User login
FFR-guided PCI in stable CAD beats medical management
DENVER – Percutaneous coronary intervention plus optimal medical therapy in stable coronary artery disease (CAD) patients with at least one coronary lesion having an abnormal fractional flow reserve measurement resulted in superior clinical outcomes, better quality of life, and virtually identical cost, compared with optimal medical management alone over 3 years of follow-up in the FAME 2 trial.
“These results reinforce the point that the greater the burden of ischemia, the greater the benefit of revascularization with PCI [percutaneous coronary intervention],” William F. Fearon, MD, said while presenting the FAME 2 findings at the Transcatheter Cardiovascular Therapeutics annual meeting.
FAME 2 was a randomized, multicenter trial designed to help bring clarity regarding the optimal treatment strategy for patients with stable angina and CAD. This is an issue surrounded by considerable controversy. The fog descended a decade ago, when the COURAGE trial created a stir with its conclusion that optimal medical therapy (OMT) alone was as good as PCI plus OMT in terms of clinical outcome and quality of life – and was considerably less expensive as well. And the British ORBITA trial, presented earlier in the same session at TCT 2017 as Dr. Fearon’s report on FAME 2, caused an uproar with its finding that PCI plus OMT was no more effective than sham PCI plus OMT in the setting of stable CAD.
However, FAME 2 (Fractional Flow Reserve versus Angiography for Multivessel Evaluation) differed from those studies in a crucial aspect: randomization in FAME 2 was restricted to patients with physiologically significant cardiac ischemia as evidenced by a fractional flow reserve (FFR) measurement of 0.80 or less.
In contrast, COURAGE and ORBITA randomized patients without FFR guidance. As a result, in those trials PCI was performed in a substantial proportion of patients who actually should not have undergone the intervention because they didn’t have physiologic evidence of clinically important ischemia. The non–physiologically based approach to PCI utilized in COURAGE and ORBITA – disappointingly commonplace in daily clinical practice – diluted any true benefit of the procedure when applied appropriately, explained Dr. Fearon, professor of medicine and director of interventional cardiology at Stanford (Calif.) University.
FAME 2 randomized 888 patients with stable single- or multivessel CAD and an FFR of 0.80 or less to PCI plus OMT or an initial strategy of OMT alone at 28 European and North American sites. The primary outcome was the rate of major adverse cardiac events – death, MI, and urgent revascularization – at 3 years. The rate was 10.1% in the PCI group, compared with 22% in the medically managed cohort, Dr. Fearon reported at the meeting sponsored by the Cardiovascular Research Foundation.
Death or MI occurred in 8.3% of the PCI group versus 10.4% in the OMT group, a trend that didn’t reach significance. Of note, however, fully 44% of patients in the OMT group crossed over to PCI during the 3-year study. In the prespecified intent-to-treat analysis they were counted in the OMT group, whereas an as-treated analysis might well have shown statistically significant reductions in death and MI in the PCI group.
The proportion of patients with class II-IV angina was significantly lower in the PCI plus medical therapy group at every time point, including 5.9% versus 15.2% for OMT alone at 1 year, 5.9% versus 12% at 2 years, and 5.2% versus 9.7% at 3 years. This was the case even though the OMT group received significantly more antianginal therapy in an effort to control symptoms.
FAME 2 featured a first-of-its-kind comprehensive cost-effectiveness analysis of OMT vs. PCI over a 3-year period. It showed that, while mean initial costs were as expected higher in the PCI group ($9,944 versus $4,440), by 3 years the cumulative costs were near identical at $16,792 in the PCI group and $16,737 in the initial OMT group. The incremental cost-effectiveness ratio for PCI, compared with OMT at 3 years was attractive at $1,600 per quality-adjusted life-year gained.
The question on TCT attendees’ minds following presentation of the bombshell ORBITA findings was, what would have happened had FAME 2 featured a sham PCI arm? Could the advantageous outcomes for the initial PCI strategy seen in FAME 2 possibly have been due to a placebo effect?
Extremely unlikely, according to Dr. Fearon. For one thing, when he and his coinvestigators broke down the FFR values in the OMT group into quintiles, they saw a clear dose-response effect: The clinical event rate rose further with worsening quintile of FFR. Also, the study endpoints were death, MI, and urgent revascularization – triggered by ACS in half of cases – which are less susceptible to a placebo effect than, say, treadmill exercise time, the primary endpoint in ORBITA.
Moreover, as noted by Gary S. Mintz, MD, who moderated a press conference highlighting the ORBITA and FAME 2 results, placebo effects don’t last for years.
“Most people would say the placebo effect wanes over time. That’s why these 3-year data, analyzed by intent-to-treat, which allow for crossovers to still be analyzed in the medical therapy arm, are pretty compelling to me,” commented Dr. Mintz, chief medical officer for the Cardiovascular Research Foundation in New York.
FAME 2 was supported by St. Jude Medical. Dr. Fearon reported receiving institutional research support from Medtronic, Abbott Vascular, ACIST Medical, CathWorks, and Edwards LifeSciences.
DENVER – Percutaneous coronary intervention plus optimal medical therapy in stable coronary artery disease (CAD) patients with at least one coronary lesion having an abnormal fractional flow reserve measurement resulted in superior clinical outcomes, better quality of life, and virtually identical cost, compared with optimal medical management alone over 3 years of follow-up in the FAME 2 trial.
“These results reinforce the point that the greater the burden of ischemia, the greater the benefit of revascularization with PCI [percutaneous coronary intervention],” William F. Fearon, MD, said while presenting the FAME 2 findings at the Transcatheter Cardiovascular Therapeutics annual meeting.
FAME 2 was a randomized, multicenter trial designed to help bring clarity regarding the optimal treatment strategy for patients with stable angina and CAD. This is an issue surrounded by considerable controversy. The fog descended a decade ago, when the COURAGE trial created a stir with its conclusion that optimal medical therapy (OMT) alone was as good as PCI plus OMT in terms of clinical outcome and quality of life – and was considerably less expensive as well. And the British ORBITA trial, presented earlier in the same session at TCT 2017 as Dr. Fearon’s report on FAME 2, caused an uproar with its finding that PCI plus OMT was no more effective than sham PCI plus OMT in the setting of stable CAD.
However, FAME 2 (Fractional Flow Reserve versus Angiography for Multivessel Evaluation) differed from those studies in a crucial aspect: randomization in FAME 2 was restricted to patients with physiologically significant cardiac ischemia as evidenced by a fractional flow reserve (FFR) measurement of 0.80 or less.
In contrast, COURAGE and ORBITA randomized patients without FFR guidance. As a result, in those trials PCI was performed in a substantial proportion of patients who actually should not have undergone the intervention because they didn’t have physiologic evidence of clinically important ischemia. The non–physiologically based approach to PCI utilized in COURAGE and ORBITA – disappointingly commonplace in daily clinical practice – diluted any true benefit of the procedure when applied appropriately, explained Dr. Fearon, professor of medicine and director of interventional cardiology at Stanford (Calif.) University.
FAME 2 randomized 888 patients with stable single- or multivessel CAD and an FFR of 0.80 or less to PCI plus OMT or an initial strategy of OMT alone at 28 European and North American sites. The primary outcome was the rate of major adverse cardiac events – death, MI, and urgent revascularization – at 3 years. The rate was 10.1% in the PCI group, compared with 22% in the medically managed cohort, Dr. Fearon reported at the meeting sponsored by the Cardiovascular Research Foundation.
Death or MI occurred in 8.3% of the PCI group versus 10.4% in the OMT group, a trend that didn’t reach significance. Of note, however, fully 44% of patients in the OMT group crossed over to PCI during the 3-year study. In the prespecified intent-to-treat analysis they were counted in the OMT group, whereas an as-treated analysis might well have shown statistically significant reductions in death and MI in the PCI group.
The proportion of patients with class II-IV angina was significantly lower in the PCI plus medical therapy group at every time point, including 5.9% versus 15.2% for OMT alone at 1 year, 5.9% versus 12% at 2 years, and 5.2% versus 9.7% at 3 years. This was the case even though the OMT group received significantly more antianginal therapy in an effort to control symptoms.
FAME 2 featured a first-of-its-kind comprehensive cost-effectiveness analysis of OMT vs. PCI over a 3-year period. It showed that, while mean initial costs were as expected higher in the PCI group ($9,944 versus $4,440), by 3 years the cumulative costs were near identical at $16,792 in the PCI group and $16,737 in the initial OMT group. The incremental cost-effectiveness ratio for PCI, compared with OMT at 3 years was attractive at $1,600 per quality-adjusted life-year gained.
The question on TCT attendees’ minds following presentation of the bombshell ORBITA findings was, what would have happened had FAME 2 featured a sham PCI arm? Could the advantageous outcomes for the initial PCI strategy seen in FAME 2 possibly have been due to a placebo effect?
Extremely unlikely, according to Dr. Fearon. For one thing, when he and his coinvestigators broke down the FFR values in the OMT group into quintiles, they saw a clear dose-response effect: The clinical event rate rose further with worsening quintile of FFR. Also, the study endpoints were death, MI, and urgent revascularization – triggered by ACS in half of cases – which are less susceptible to a placebo effect than, say, treadmill exercise time, the primary endpoint in ORBITA.
Moreover, as noted by Gary S. Mintz, MD, who moderated a press conference highlighting the ORBITA and FAME 2 results, placebo effects don’t last for years.
“Most people would say the placebo effect wanes over time. That’s why these 3-year data, analyzed by intent-to-treat, which allow for crossovers to still be analyzed in the medical therapy arm, are pretty compelling to me,” commented Dr. Mintz, chief medical officer for the Cardiovascular Research Foundation in New York.
FAME 2 was supported by St. Jude Medical. Dr. Fearon reported receiving institutional research support from Medtronic, Abbott Vascular, ACIST Medical, CathWorks, and Edwards LifeSciences.
DENVER – Percutaneous coronary intervention plus optimal medical therapy in stable coronary artery disease (CAD) patients with at least one coronary lesion having an abnormal fractional flow reserve measurement resulted in superior clinical outcomes, better quality of life, and virtually identical cost, compared with optimal medical management alone over 3 years of follow-up in the FAME 2 trial.
“These results reinforce the point that the greater the burden of ischemia, the greater the benefit of revascularization with PCI [percutaneous coronary intervention],” William F. Fearon, MD, said while presenting the FAME 2 findings at the Transcatheter Cardiovascular Therapeutics annual meeting.
FAME 2 was a randomized, multicenter trial designed to help bring clarity regarding the optimal treatment strategy for patients with stable angina and CAD. This is an issue surrounded by considerable controversy. The fog descended a decade ago, when the COURAGE trial created a stir with its conclusion that optimal medical therapy (OMT) alone was as good as PCI plus OMT in terms of clinical outcome and quality of life – and was considerably less expensive as well. And the British ORBITA trial, presented earlier in the same session at TCT 2017 as Dr. Fearon’s report on FAME 2, caused an uproar with its finding that PCI plus OMT was no more effective than sham PCI plus OMT in the setting of stable CAD.
However, FAME 2 (Fractional Flow Reserve versus Angiography for Multivessel Evaluation) differed from those studies in a crucial aspect: randomization in FAME 2 was restricted to patients with physiologically significant cardiac ischemia as evidenced by a fractional flow reserve (FFR) measurement of 0.80 or less.
In contrast, COURAGE and ORBITA randomized patients without FFR guidance. As a result, in those trials PCI was performed in a substantial proportion of patients who actually should not have undergone the intervention because they didn’t have physiologic evidence of clinically important ischemia. The non–physiologically based approach to PCI utilized in COURAGE and ORBITA – disappointingly commonplace in daily clinical practice – diluted any true benefit of the procedure when applied appropriately, explained Dr. Fearon, professor of medicine and director of interventional cardiology at Stanford (Calif.) University.
FAME 2 randomized 888 patients with stable single- or multivessel CAD and an FFR of 0.80 or less to PCI plus OMT or an initial strategy of OMT alone at 28 European and North American sites. The primary outcome was the rate of major adverse cardiac events – death, MI, and urgent revascularization – at 3 years. The rate was 10.1% in the PCI group, compared with 22% in the medically managed cohort, Dr. Fearon reported at the meeting sponsored by the Cardiovascular Research Foundation.
Death or MI occurred in 8.3% of the PCI group versus 10.4% in the OMT group, a trend that didn’t reach significance. Of note, however, fully 44% of patients in the OMT group crossed over to PCI during the 3-year study. In the prespecified intent-to-treat analysis they were counted in the OMT group, whereas an as-treated analysis might well have shown statistically significant reductions in death and MI in the PCI group.
The proportion of patients with class II-IV angina was significantly lower in the PCI plus medical therapy group at every time point, including 5.9% versus 15.2% for OMT alone at 1 year, 5.9% versus 12% at 2 years, and 5.2% versus 9.7% at 3 years. This was the case even though the OMT group received significantly more antianginal therapy in an effort to control symptoms.
FAME 2 featured a first-of-its-kind comprehensive cost-effectiveness analysis of OMT vs. PCI over a 3-year period. It showed that, while mean initial costs were as expected higher in the PCI group ($9,944 versus $4,440), by 3 years the cumulative costs were near identical at $16,792 in the PCI group and $16,737 in the initial OMT group. The incremental cost-effectiveness ratio for PCI, compared with OMT at 3 years was attractive at $1,600 per quality-adjusted life-year gained.
The question on TCT attendees’ minds following presentation of the bombshell ORBITA findings was, what would have happened had FAME 2 featured a sham PCI arm? Could the advantageous outcomes for the initial PCI strategy seen in FAME 2 possibly have been due to a placebo effect?
Extremely unlikely, according to Dr. Fearon. For one thing, when he and his coinvestigators broke down the FFR values in the OMT group into quintiles, they saw a clear dose-response effect: The clinical event rate rose further with worsening quintile of FFR. Also, the study endpoints were death, MI, and urgent revascularization – triggered by ACS in half of cases – which are less susceptible to a placebo effect than, say, treadmill exercise time, the primary endpoint in ORBITA.
Moreover, as noted by Gary S. Mintz, MD, who moderated a press conference highlighting the ORBITA and FAME 2 results, placebo effects don’t last for years.
“Most people would say the placebo effect wanes over time. That’s why these 3-year data, analyzed by intent-to-treat, which allow for crossovers to still be analyzed in the medical therapy arm, are pretty compelling to me,” commented Dr. Mintz, chief medical officer for the Cardiovascular Research Foundation in New York.
FAME 2 was supported by St. Jude Medical. Dr. Fearon reported receiving institutional research support from Medtronic, Abbott Vascular, ACIST Medical, CathWorks, and Edwards LifeSciences.
REPORTING FROM TCT 2017
Key clinical point:
Major finding: The rate of major adverse cardiac events at 3 years was 10.1% in the PCI group and 22% in the medically managed cohort.
Data source: The FAME 2 trial randomized 888 patients with stable single- or multivessel CAD and an FFR of 0.80 or less to PCI plus optimal medical therapy or an initial strategy of optimal medical management alone.
Disclosures: The trial was supported by St. Jude Medical. The presenter reported receiving institutional research support from Medtronic, Abbott Vascular, ACIST Medical, CathWorks, and Edwards LifeSciences.
EVAR, venous CPT coding revamped for 2018
CHICAGO – Current Procedural Terminology coding for endovascular aneurysm repair has been totally overhauled for 2018 with the introduction of a family of 20 new codes and codes for other vascular procedures have also been updated.
The new EVAR CPT codes attempt to capture the work involved in performing the procedures based upon the anatomy of the aneurysm and the treated vessels rather than being device-based, as previously, Matthew J. Sideman, MD, explained in presenting the coding and reimbursement for 2018 at a symposium on vascular surgery sponsored by Northwestern University.
“The new EVAR codes for 2018 have got a lot of gains. There are some losses as well, but overall, I think it’s going to be very positive moving forward,” according to Dr. Sideman, a vascular surgeon at the University of Texas, San Antonio, who serves as chair of the Society for Vascular Surgery Coding and Reimbursement Committee and an adviser to the American Medical Association Relative Value Scale Update Committee (RUC).
“What we gained was a new code for ruptured aneurysm repair, a new code for enhanced fixation, a new code for percutaneous access, new codes for alternative access options, and now all the access codes are add-on codes. But what we traded off was loss due to bundling. So catheterization is now bundled into the main procedure, radiographic supervision and interpretation is now bundled. The big thing that really hurt was we lost all proximal extensions to the renal arteries and all distal extensions to the iliac bifurcations – they’re also bundled into the main procedure,” he said.
Restructuring the EVAR codes was a multiyear collaborative project of the SVS, the American College of Surgeons, the Society of Interventional Radiology, the Society of Thoracic Surgery, the American College of Cardiology, and the Society for Cardiovascular Angiography and Interventions. The impetus was twofold: recognition that the existing codes seriously undervalued the work involved in EVAR because, for example, they didn’t distinguish between ruptured and elective aneurysm repair, nor did they recognize the unique challenges and advantages of percutaneous access.
Also, representatives of the professional societies involved with vascular medicine recognized that they had to develop a detailed proposal for coding restructuring or matters might be taken out of their hands. Bundling of codes has become the prevailing dogma at the RUC and the Centers for Medicare and Medicaid. Their current policy is that when analysis of coding patterns indicates two codes are billed together at least 51% of the time, that’s considered a ‘typical’ situation and a new code must be created combining them. The harsh reality for clinicians is that under what Dr. Sideman called “RUC math,” the new bundled codes invariably pay less than the two old ones.
“There was a little bit of smoke and mirrors – ‘Look at the pretty flashing lights and not what’s going on behind over here’ – as we tried to maintain value as we bundled these EVAR codes,” Dr. Sideman recalled. “I can stand here and tell you I did my very best to push for the best values possible. It can be a painful process, but I thought we came out ok.”
How the new EVAR codes work
Dr. Sideman explained that the impact of the new EVAR codes will depend upon a surgeon’s practice pattern.
He offered as a concrete example a patient undergoing elective EVAR of the aorta and both iliac arteries with percutaneous access and placement of a bifurcated device with one docking limb. In 2017, this might have been handled using CPT codes 34802, 36200-50, and 75952-26, for a total of 31.05 Relative Value Units (RVUs) of work.
In 2018, however, this same surgical strategy would be coded as 34705 (elective endovascular repair of infrarenal aorta and/or iliac artery or arteries) plus 34713 x 2 (percutaneous access and closure), for a total of 34.58 RVUs. Thus, the surgeon would come out 3.53 RVUs ahead in 2018, which at a conversion factor of $35.78/RVU translates to an extra $126.30.
On the other hand, if the surgeon chose to use a bifurcated device with one docking limb, a left iliac bell-bottom extension, a right iliac bell-bottom extension, and percutaneous access, in 2017, this would have been coded as 34802, 34825, 34826, 36200-50, 75952-26, and 75953-26 x 2, for a total of 44.29 RVUs of work. In 2018, this same treatment strategy would be coded as 34705 plus 34713 x 2, for a total of 34.58 RVUs, or a knockdown of 9.71 fewer RVUs compared with the year before, which translates to $347.42 less.
“The more extensions you use, the more you’re going to come out behind going forward,” according to Dr. Sideman.
Other coding changes in 2018
Sclerotherapy of single and multiple veins (codes 36470 and 36471) got down-valued from 1.10 and 2.49 to 0.75 and 1.5 RVUs, respectively.
Angiography of the extremities (75710 and 75716) will be better reimbursed in 2018. In what Dr. Sideman called “a good win,” unilateral angiography will be rated as 1.75 RVUs, up from 1.14 in 2017, while bilateral angiography increased from 1.31 to 1.97 RVUs.
“The other nice thing I can tell you is that through campaigning and lobbying and comments to CMS [Centers for Medicare & Medicaid Services], we got them to reverse their recommendations from 2017 to 2018 on the dialysis family of codes,” the surgeon continued.
Reimbursement for the dialysis codes took a big hit from 2016 to 2017, amounting to several hundred million dollars less in reimbursement, but CMS has reversed its policy on that score. The RVUs for the various dialysis codes have increased from 2017 to 2018 by 5%-21%, with central venous angioplasty (CPT 36907) garnering the biggest increase.
Existing RVUs were retained for 2018 in three of the four selective catheter placement codes. However, reimbursement for 36215 (first order catheterization of the thoracic or brachiocephalic branch) dropped from 4.67 to 4.17 RVUs because physician surveys showed the time involved was less than previously rated. Once the RUC and CMS saw that the time involved in a procedure has decreased, it became impossible to maintain the RVU, Dr. Sideman explained.
And speaking of time involved in procedures, Dr. Sideman offered a final plea to his vascular medicine colleagues:
“When you get surveys from the RUC asking for your input, please, please, please, fill them out because that’s how we get our direct physician input into the valuation of codes.”
He reported having no financial conflicts of interest regarding his presentation.
A detailed listing of many of the codes and changes can be found at the American College of Radiology website, and the Society for Vascular Surgery has coding resources available on their website, as well.
CHICAGO – Current Procedural Terminology coding for endovascular aneurysm repair has been totally overhauled for 2018 with the introduction of a family of 20 new codes and codes for other vascular procedures have also been updated.
The new EVAR CPT codes attempt to capture the work involved in performing the procedures based upon the anatomy of the aneurysm and the treated vessels rather than being device-based, as previously, Matthew J. Sideman, MD, explained in presenting the coding and reimbursement for 2018 at a symposium on vascular surgery sponsored by Northwestern University.
“The new EVAR codes for 2018 have got a lot of gains. There are some losses as well, but overall, I think it’s going to be very positive moving forward,” according to Dr. Sideman, a vascular surgeon at the University of Texas, San Antonio, who serves as chair of the Society for Vascular Surgery Coding and Reimbursement Committee and an adviser to the American Medical Association Relative Value Scale Update Committee (RUC).
“What we gained was a new code for ruptured aneurysm repair, a new code for enhanced fixation, a new code for percutaneous access, new codes for alternative access options, and now all the access codes are add-on codes. But what we traded off was loss due to bundling. So catheterization is now bundled into the main procedure, radiographic supervision and interpretation is now bundled. The big thing that really hurt was we lost all proximal extensions to the renal arteries and all distal extensions to the iliac bifurcations – they’re also bundled into the main procedure,” he said.
Restructuring the EVAR codes was a multiyear collaborative project of the SVS, the American College of Surgeons, the Society of Interventional Radiology, the Society of Thoracic Surgery, the American College of Cardiology, and the Society for Cardiovascular Angiography and Interventions. The impetus was twofold: recognition that the existing codes seriously undervalued the work involved in EVAR because, for example, they didn’t distinguish between ruptured and elective aneurysm repair, nor did they recognize the unique challenges and advantages of percutaneous access.
Also, representatives of the professional societies involved with vascular medicine recognized that they had to develop a detailed proposal for coding restructuring or matters might be taken out of their hands. Bundling of codes has become the prevailing dogma at the RUC and the Centers for Medicare and Medicaid. Their current policy is that when analysis of coding patterns indicates two codes are billed together at least 51% of the time, that’s considered a ‘typical’ situation and a new code must be created combining them. The harsh reality for clinicians is that under what Dr. Sideman called “RUC math,” the new bundled codes invariably pay less than the two old ones.
“There was a little bit of smoke and mirrors – ‘Look at the pretty flashing lights and not what’s going on behind over here’ – as we tried to maintain value as we bundled these EVAR codes,” Dr. Sideman recalled. “I can stand here and tell you I did my very best to push for the best values possible. It can be a painful process, but I thought we came out ok.”
How the new EVAR codes work
Dr. Sideman explained that the impact of the new EVAR codes will depend upon a surgeon’s practice pattern.
He offered as a concrete example a patient undergoing elective EVAR of the aorta and both iliac arteries with percutaneous access and placement of a bifurcated device with one docking limb. In 2017, this might have been handled using CPT codes 34802, 36200-50, and 75952-26, for a total of 31.05 Relative Value Units (RVUs) of work.
In 2018, however, this same surgical strategy would be coded as 34705 (elective endovascular repair of infrarenal aorta and/or iliac artery or arteries) plus 34713 x 2 (percutaneous access and closure), for a total of 34.58 RVUs. Thus, the surgeon would come out 3.53 RVUs ahead in 2018, which at a conversion factor of $35.78/RVU translates to an extra $126.30.
On the other hand, if the surgeon chose to use a bifurcated device with one docking limb, a left iliac bell-bottom extension, a right iliac bell-bottom extension, and percutaneous access, in 2017, this would have been coded as 34802, 34825, 34826, 36200-50, 75952-26, and 75953-26 x 2, for a total of 44.29 RVUs of work. In 2018, this same treatment strategy would be coded as 34705 plus 34713 x 2, for a total of 34.58 RVUs, or a knockdown of 9.71 fewer RVUs compared with the year before, which translates to $347.42 less.
“The more extensions you use, the more you’re going to come out behind going forward,” according to Dr. Sideman.
Other coding changes in 2018
Sclerotherapy of single and multiple veins (codes 36470 and 36471) got down-valued from 1.10 and 2.49 to 0.75 and 1.5 RVUs, respectively.
Angiography of the extremities (75710 and 75716) will be better reimbursed in 2018. In what Dr. Sideman called “a good win,” unilateral angiography will be rated as 1.75 RVUs, up from 1.14 in 2017, while bilateral angiography increased from 1.31 to 1.97 RVUs.
“The other nice thing I can tell you is that through campaigning and lobbying and comments to CMS [Centers for Medicare & Medicaid Services], we got them to reverse their recommendations from 2017 to 2018 on the dialysis family of codes,” the surgeon continued.
Reimbursement for the dialysis codes took a big hit from 2016 to 2017, amounting to several hundred million dollars less in reimbursement, but CMS has reversed its policy on that score. The RVUs for the various dialysis codes have increased from 2017 to 2018 by 5%-21%, with central venous angioplasty (CPT 36907) garnering the biggest increase.
Existing RVUs were retained for 2018 in three of the four selective catheter placement codes. However, reimbursement for 36215 (first order catheterization of the thoracic or brachiocephalic branch) dropped from 4.67 to 4.17 RVUs because physician surveys showed the time involved was less than previously rated. Once the RUC and CMS saw that the time involved in a procedure has decreased, it became impossible to maintain the RVU, Dr. Sideman explained.
And speaking of time involved in procedures, Dr. Sideman offered a final plea to his vascular medicine colleagues:
“When you get surveys from the RUC asking for your input, please, please, please, fill them out because that’s how we get our direct physician input into the valuation of codes.”
He reported having no financial conflicts of interest regarding his presentation.
A detailed listing of many of the codes and changes can be found at the American College of Radiology website, and the Society for Vascular Surgery has coding resources available on their website, as well.
CHICAGO – Current Procedural Terminology coding for endovascular aneurysm repair has been totally overhauled for 2018 with the introduction of a family of 20 new codes and codes for other vascular procedures have also been updated.
The new EVAR CPT codes attempt to capture the work involved in performing the procedures based upon the anatomy of the aneurysm and the treated vessels rather than being device-based, as previously, Matthew J. Sideman, MD, explained in presenting the coding and reimbursement for 2018 at a symposium on vascular surgery sponsored by Northwestern University.
“The new EVAR codes for 2018 have got a lot of gains. There are some losses as well, but overall, I think it’s going to be very positive moving forward,” according to Dr. Sideman, a vascular surgeon at the University of Texas, San Antonio, who serves as chair of the Society for Vascular Surgery Coding and Reimbursement Committee and an adviser to the American Medical Association Relative Value Scale Update Committee (RUC).
“What we gained was a new code for ruptured aneurysm repair, a new code for enhanced fixation, a new code for percutaneous access, new codes for alternative access options, and now all the access codes are add-on codes. But what we traded off was loss due to bundling. So catheterization is now bundled into the main procedure, radiographic supervision and interpretation is now bundled. The big thing that really hurt was we lost all proximal extensions to the renal arteries and all distal extensions to the iliac bifurcations – they’re also bundled into the main procedure,” he said.
Restructuring the EVAR codes was a multiyear collaborative project of the SVS, the American College of Surgeons, the Society of Interventional Radiology, the Society of Thoracic Surgery, the American College of Cardiology, and the Society for Cardiovascular Angiography and Interventions. The impetus was twofold: recognition that the existing codes seriously undervalued the work involved in EVAR because, for example, they didn’t distinguish between ruptured and elective aneurysm repair, nor did they recognize the unique challenges and advantages of percutaneous access.
Also, representatives of the professional societies involved with vascular medicine recognized that they had to develop a detailed proposal for coding restructuring or matters might be taken out of their hands. Bundling of codes has become the prevailing dogma at the RUC and the Centers for Medicare and Medicaid. Their current policy is that when analysis of coding patterns indicates two codes are billed together at least 51% of the time, that’s considered a ‘typical’ situation and a new code must be created combining them. The harsh reality for clinicians is that under what Dr. Sideman called “RUC math,” the new bundled codes invariably pay less than the two old ones.
“There was a little bit of smoke and mirrors – ‘Look at the pretty flashing lights and not what’s going on behind over here’ – as we tried to maintain value as we bundled these EVAR codes,” Dr. Sideman recalled. “I can stand here and tell you I did my very best to push for the best values possible. It can be a painful process, but I thought we came out ok.”
How the new EVAR codes work
Dr. Sideman explained that the impact of the new EVAR codes will depend upon a surgeon’s practice pattern.
He offered as a concrete example a patient undergoing elective EVAR of the aorta and both iliac arteries with percutaneous access and placement of a bifurcated device with one docking limb. In 2017, this might have been handled using CPT codes 34802, 36200-50, and 75952-26, for a total of 31.05 Relative Value Units (RVUs) of work.
In 2018, however, this same surgical strategy would be coded as 34705 (elective endovascular repair of infrarenal aorta and/or iliac artery or arteries) plus 34713 x 2 (percutaneous access and closure), for a total of 34.58 RVUs. Thus, the surgeon would come out 3.53 RVUs ahead in 2018, which at a conversion factor of $35.78/RVU translates to an extra $126.30.
On the other hand, if the surgeon chose to use a bifurcated device with one docking limb, a left iliac bell-bottom extension, a right iliac bell-bottom extension, and percutaneous access, in 2017, this would have been coded as 34802, 34825, 34826, 36200-50, 75952-26, and 75953-26 x 2, for a total of 44.29 RVUs of work. In 2018, this same treatment strategy would be coded as 34705 plus 34713 x 2, for a total of 34.58 RVUs, or a knockdown of 9.71 fewer RVUs compared with the year before, which translates to $347.42 less.
“The more extensions you use, the more you’re going to come out behind going forward,” according to Dr. Sideman.
Other coding changes in 2018
Sclerotherapy of single and multiple veins (codes 36470 and 36471) got down-valued from 1.10 and 2.49 to 0.75 and 1.5 RVUs, respectively.
Angiography of the extremities (75710 and 75716) will be better reimbursed in 2018. In what Dr. Sideman called “a good win,” unilateral angiography will be rated as 1.75 RVUs, up from 1.14 in 2017, while bilateral angiography increased from 1.31 to 1.97 RVUs.
“The other nice thing I can tell you is that through campaigning and lobbying and comments to CMS [Centers for Medicare & Medicaid Services], we got them to reverse their recommendations from 2017 to 2018 on the dialysis family of codes,” the surgeon continued.
Reimbursement for the dialysis codes took a big hit from 2016 to 2017, amounting to several hundred million dollars less in reimbursement, but CMS has reversed its policy on that score. The RVUs for the various dialysis codes have increased from 2017 to 2018 by 5%-21%, with central venous angioplasty (CPT 36907) garnering the biggest increase.
Existing RVUs were retained for 2018 in three of the four selective catheter placement codes. However, reimbursement for 36215 (first order catheterization of the thoracic or brachiocephalic branch) dropped from 4.67 to 4.17 RVUs because physician surveys showed the time involved was less than previously rated. Once the RUC and CMS saw that the time involved in a procedure has decreased, it became impossible to maintain the RVU, Dr. Sideman explained.
And speaking of time involved in procedures, Dr. Sideman offered a final plea to his vascular medicine colleagues:
“When you get surveys from the RUC asking for your input, please, please, please, fill them out because that’s how we get our direct physician input into the valuation of codes.”
He reported having no financial conflicts of interest regarding his presentation.
A detailed listing of many of the codes and changes can be found at the American College of Radiology website, and the Society for Vascular Surgery has coding resources available on their website, as well.
EXPERT ANALYSIS FROM THE NORTHWESTERN VASCULAR SYMPOSIUM
QI enthusiast to QI leader: Sheri Chernetsky Tejedor, MD
Armed with a background in engineering, Sheri Chernetsky Tejedor, MD, SFHM, had already adopted a mindset of system reliability and design improvement when she began her journey in hospital medicine at Johns Hopkins University in Baltimore.
After completing her studies there, Dr. Tejedor was quick to find a place at Emory Healthcare in Atlanta and began working toward a future in health care quality improvement (QI).
“I gravitated early on toward what was essentially quality improvement work,” Dr. Tejedor told The Hospitalist.
Dr. Tejedor worked with two mentors at a community hospital associated with Emory University who helped influence her success in QI: Mark V. Williams, MD, FACP, MHM, who is now the director of the Center for Health Services Research at the University of Kentucky in Lexington, and Jason Stein, MD, SFHM, who is currently a hospitalist at Emory University Hospital.
“They wanted to develop quality improvement expertise and get some of us trained,” she said. “These advocates, or mentors, were critical for me. They are people who went above and beyond to help with career planning and thinking through possibilities.”
Dr. Tejedor and Dr. Stein traveled to Intermountain Healthcare, a not-for-profit health system based in Salt Lake City that focuses on medical innovation, to participate in a rigorous quality training program.
“It was extremely intense,” said Dr. Tejedor. “You worked over several months to get a certificate from the Institute for Healthcare Delivery Research, and it’s all focused on quality improvement methodology.”
After completing this program, Dr. Tejedor continued on her quality improvement path by focusing on research while also simultaneously working part time and taking care of her three young children. During this phase of her career, Dr. Tejedor and her colleagues published a study on idle central venous catheters, which became a primary reference for part of the ABIM Foundation’s Choosing Wisely® campaign.
Dr. Tejedor said that, in addition to research, she explored different leadership roles, such as taking charge of central line teams and nurses working on device insertion practices. Her successful projects drew notice, and soon Dr. Tejedor and Dr. Stein helped to implement a stronger focus on quality improvement at their organization.
“Our health system was very entrenched in that QI culture,” Dr. Tejedor said. “After Jason and I went to Intermountain, many of the Emory Healthcare leadership also got trained in Utah, and we ultimately built a quality course at Emory that mirrored it.”
Dr. Tejedor’s research evolved to intersect with clinical informatics. She leveraged the organization’s electronic medical record to test her work.
“[The EMR] is ubiquitous, and that was a good way to reach staff, test interventions, and get data,” Dr. Tejedor said. “I built a lot of tools that were helpful for the health system.”
One of these tools was a device to monitor central line infections that was linked with clinical informatics as part of a large grant project. This led to another leadership opportunity: She assumed the role of chief research information officer and director for analytics at Emory Healthcare in 2013.
In 2014, Dr. Tejedor began working with the Centers for Disease Control and Prevention as the first hospitalist and informatics specialist on the Healthcare Infection Control Practices Advisory Committee, where she continues to hold a position. She is also a medical advisor for the CDC’s Division of Healthcare Quality Promotion, focusing on electronic quality measures.
For those hospitalists pursuing QI, exposure to formal training is essential, Dr. Tejedor said. That may not mean flying to Utah, she noted, but garnering a deeper understanding of informatics is crucial.
When it comes to leadership, Dr. Tejedor recommends that those looking to take charge develop social skills and embrace parts of medicine that may be unfamiliar yet essential.
“Learn a little bit about the business side, which you may not know much about as a doctor taking care of patients,” she said. “Learn just enough to understand what goes into people’s decision making when they are choosing what projects get approved.”
Dr. Tejedor encourages hospitalists to focus on developing relationships because that was one of the keys to her success as a quality improvement leader.
“It’s about gaining the trust of the staff, mutual respect, working with the nurses, and getting to know the leadership and the people who make the financial decisions,” she said. “Even if you have the money for a quality improvement project, it will fail if you don’t work with the various teams to understand their needs and how to make it work for them.”
[email protected]
On Twitter @eaztweets
Armed with a background in engineering, Sheri Chernetsky Tejedor, MD, SFHM, had already adopted a mindset of system reliability and design improvement when she began her journey in hospital medicine at Johns Hopkins University in Baltimore.
After completing her studies there, Dr. Tejedor was quick to find a place at Emory Healthcare in Atlanta and began working toward a future in health care quality improvement (QI).
“I gravitated early on toward what was essentially quality improvement work,” Dr. Tejedor told The Hospitalist.
Dr. Tejedor worked with two mentors at a community hospital associated with Emory University who helped influence her success in QI: Mark V. Williams, MD, FACP, MHM, who is now the director of the Center for Health Services Research at the University of Kentucky in Lexington, and Jason Stein, MD, SFHM, who is currently a hospitalist at Emory University Hospital.
“They wanted to develop quality improvement expertise and get some of us trained,” she said. “These advocates, or mentors, were critical for me. They are people who went above and beyond to help with career planning and thinking through possibilities.”
Dr. Tejedor and Dr. Stein traveled to Intermountain Healthcare, a not-for-profit health system based in Salt Lake City that focuses on medical innovation, to participate in a rigorous quality training program.
“It was extremely intense,” said Dr. Tejedor. “You worked over several months to get a certificate from the Institute for Healthcare Delivery Research, and it’s all focused on quality improvement methodology.”
After completing this program, Dr. Tejedor continued on her quality improvement path by focusing on research while also simultaneously working part time and taking care of her three young children. During this phase of her career, Dr. Tejedor and her colleagues published a study on idle central venous catheters, which became a primary reference for part of the ABIM Foundation’s Choosing Wisely® campaign.
Dr. Tejedor said that, in addition to research, she explored different leadership roles, such as taking charge of central line teams and nurses working on device insertion practices. Her successful projects drew notice, and soon Dr. Tejedor and Dr. Stein helped to implement a stronger focus on quality improvement at their organization.
“Our health system was very entrenched in that QI culture,” Dr. Tejedor said. “After Jason and I went to Intermountain, many of the Emory Healthcare leadership also got trained in Utah, and we ultimately built a quality course at Emory that mirrored it.”
Dr. Tejedor’s research evolved to intersect with clinical informatics. She leveraged the organization’s electronic medical record to test her work.
“[The EMR] is ubiquitous, and that was a good way to reach staff, test interventions, and get data,” Dr. Tejedor said. “I built a lot of tools that were helpful for the health system.”
One of these tools was a device to monitor central line infections that was linked with clinical informatics as part of a large grant project. This led to another leadership opportunity: She assumed the role of chief research information officer and director for analytics at Emory Healthcare in 2013.
In 2014, Dr. Tejedor began working with the Centers for Disease Control and Prevention as the first hospitalist and informatics specialist on the Healthcare Infection Control Practices Advisory Committee, where she continues to hold a position. She is also a medical advisor for the CDC’s Division of Healthcare Quality Promotion, focusing on electronic quality measures.
For those hospitalists pursuing QI, exposure to formal training is essential, Dr. Tejedor said. That may not mean flying to Utah, she noted, but garnering a deeper understanding of informatics is crucial.
When it comes to leadership, Dr. Tejedor recommends that those looking to take charge develop social skills and embrace parts of medicine that may be unfamiliar yet essential.
“Learn a little bit about the business side, which you may not know much about as a doctor taking care of patients,” she said. “Learn just enough to understand what goes into people’s decision making when they are choosing what projects get approved.”
Dr. Tejedor encourages hospitalists to focus on developing relationships because that was one of the keys to her success as a quality improvement leader.
“It’s about gaining the trust of the staff, mutual respect, working with the nurses, and getting to know the leadership and the people who make the financial decisions,” she said. “Even if you have the money for a quality improvement project, it will fail if you don’t work with the various teams to understand their needs and how to make it work for them.”
[email protected]
On Twitter @eaztweets
Armed with a background in engineering, Sheri Chernetsky Tejedor, MD, SFHM, had already adopted a mindset of system reliability and design improvement when she began her journey in hospital medicine at Johns Hopkins University in Baltimore.
After completing her studies there, Dr. Tejedor was quick to find a place at Emory Healthcare in Atlanta and began working toward a future in health care quality improvement (QI).
“I gravitated early on toward what was essentially quality improvement work,” Dr. Tejedor told The Hospitalist.
Dr. Tejedor worked with two mentors at a community hospital associated with Emory University who helped influence her success in QI: Mark V. Williams, MD, FACP, MHM, who is now the director of the Center for Health Services Research at the University of Kentucky in Lexington, and Jason Stein, MD, SFHM, who is currently a hospitalist at Emory University Hospital.
“They wanted to develop quality improvement expertise and get some of us trained,” she said. “These advocates, or mentors, were critical for me. They are people who went above and beyond to help with career planning and thinking through possibilities.”
Dr. Tejedor and Dr. Stein traveled to Intermountain Healthcare, a not-for-profit health system based in Salt Lake City that focuses on medical innovation, to participate in a rigorous quality training program.
“It was extremely intense,” said Dr. Tejedor. “You worked over several months to get a certificate from the Institute for Healthcare Delivery Research, and it’s all focused on quality improvement methodology.”
After completing this program, Dr. Tejedor continued on her quality improvement path by focusing on research while also simultaneously working part time and taking care of her three young children. During this phase of her career, Dr. Tejedor and her colleagues published a study on idle central venous catheters, which became a primary reference for part of the ABIM Foundation’s Choosing Wisely® campaign.
Dr. Tejedor said that, in addition to research, she explored different leadership roles, such as taking charge of central line teams and nurses working on device insertion practices. Her successful projects drew notice, and soon Dr. Tejedor and Dr. Stein helped to implement a stronger focus on quality improvement at their organization.
“Our health system was very entrenched in that QI culture,” Dr. Tejedor said. “After Jason and I went to Intermountain, many of the Emory Healthcare leadership also got trained in Utah, and we ultimately built a quality course at Emory that mirrored it.”
Dr. Tejedor’s research evolved to intersect with clinical informatics. She leveraged the organization’s electronic medical record to test her work.
“[The EMR] is ubiquitous, and that was a good way to reach staff, test interventions, and get data,” Dr. Tejedor said. “I built a lot of tools that were helpful for the health system.”
One of these tools was a device to monitor central line infections that was linked with clinical informatics as part of a large grant project. This led to another leadership opportunity: She assumed the role of chief research information officer and director for analytics at Emory Healthcare in 2013.
In 2014, Dr. Tejedor began working with the Centers for Disease Control and Prevention as the first hospitalist and informatics specialist on the Healthcare Infection Control Practices Advisory Committee, where she continues to hold a position. She is also a medical advisor for the CDC’s Division of Healthcare Quality Promotion, focusing on electronic quality measures.
For those hospitalists pursuing QI, exposure to formal training is essential, Dr. Tejedor said. That may not mean flying to Utah, she noted, but garnering a deeper understanding of informatics is crucial.
When it comes to leadership, Dr. Tejedor recommends that those looking to take charge develop social skills and embrace parts of medicine that may be unfamiliar yet essential.
“Learn a little bit about the business side, which you may not know much about as a doctor taking care of patients,” she said. “Learn just enough to understand what goes into people’s decision making when they are choosing what projects get approved.”
Dr. Tejedor encourages hospitalists to focus on developing relationships because that was one of the keys to her success as a quality improvement leader.
“It’s about gaining the trust of the staff, mutual respect, working with the nurses, and getting to know the leadership and the people who make the financial decisions,” she said. “Even if you have the money for a quality improvement project, it will fail if you don’t work with the various teams to understand their needs and how to make it work for them.”
[email protected]
On Twitter @eaztweets
Burnout among surgical residents mitigated by traits of mindfulness
General surgery residents reported high levels of stress linked to burnout, but those who exhibited characteristics of mindfulness were less likely to experience this dynamic, a survey-based study has found.
Carter C. Lebares, MD, of the department of surgery at the University of California, San Francisco, and her colleagues wrote, “Stress is a double-edged sword, with a dose-response relationship between stress and performance described as an ‘inverted U-shaped curve.’ Although stress is initially stimulating, there is a tipping point when demands outstrip resources and stress becomes overwhelming,” the researchers wrote. Surgical trainees purposefully join a high-stress profession and presumably thrive on a demanding environment, but “that does not make individuals immune to the effects of overwhelming stress.”
The investigative team aimed to assess the prevalence and root causes of burnout among surgical trainees. They sent a survey questionnaire to 246 general surgery training program directors and asked them to distribute the survey to their residents (J Am Coll Surg. 2018 Jan;226[1]:80-90. doi: 10.1016/j.jamcollsurg.2017.10.010). The investigators focused on the components of burnout identified in the literature (emotional exhaustion, depersonalization, perceived stress, depression, anxiety, and alcohol misuse/abuse).
The survey, a voluntary and confidential exercise, was based on scales and tools to assess symptoms of burnout (Maslach Burnout Inventory), stress (Cohen’s Perceived Stress Scale), anxiety (Spielberger’s State Trait Anxiety Index), and depression/suicidal ideation (Patient Health Questionnaire).
The researchers also looked at personality traits that could make the difference between the usual stress of residency and burnout in individual trainees. Mindfulness was studied using the Cognitive Affective Mindfulness Scale–Revised. A personality characteristic “trait resilience” was captured in a 10-item Block Ego-Resiliency Scale, which measured ability to adapt to a demanding and changing environment. “Dispositional mindfulness, that is, the innate ability to pay attention to one’s thoughts, emotions, and experiences in a nonreactive way, has been shown to have a buffering effect against perceived stress and burnout among healthcare workers and trainees,” they wrote.
A total of 566 surgery residents responded to the survey; 51% were female and 76% were based in an academic training program. Overall, the survey found that burnout prevalence among general surgery residents was 69%, which confirms the findings of earlier studies of this population, and was significantly higher than rates seen in age-matched peers in the general population and among practicing surgeons. Burnout was equally prevalent among men and women, but men appeared more likely to experience depersonalization (62% vs. 51%). Emotional exhaustion was lower among lab trainees. Alcohol misuse and abuse was somewhat higher in women (58% vs. 41% and 40% vs. 26%, respectively). Although symptoms of burnout were not strongly associated with training level, PGY3 residents experienced the most (58% reported higher stress, 16% suicidal ideation, 50% high anxiety, and 61% alcohol abuse). A high level of stress was reported significantly less often by lab trainees, but alcohol misuse was significantly greater. A high level of stress and emotional exhaustion and depersonalization were strongly linked. And all of these elements were strongly associated with moderate to severe depressive symptoms, suicidal ideation, and high anxiety.
The study is limited by potential biases in the responses, inevitable in a voluntary, self-selected sample. The survey was sent to ACGME-accredited program directors who may or may not have distributed it to their trainees. The investigators suggested that whereas the findings of this study in general confirm earlier research on trainee burnout, the perception of lack personal accomplishment in this sample was less dominant in this sample. “Although this might be because we included residents in lab/research years (widely thought to be a time of very high productivity), it is more likely due to our use of an abbreviated (9-item) form of the Maslach Burnout Inventory-Human Services Survey” and therefore underreported the personal accomplishment factor.
The impact that personality traits (mindfulness and trait resilience) on burnout risk was notable in this sample. “Greater dispositional mindfulness was associated with an 85% decrease in the risk of high stress, and a greater trait resilience was associated with a 65% decrease in the risk of high stress.” Some individuals have traits to help them cope better with stress but the investigators stated that mindfulness and resilience can be taught and fostered in trainees.
The current research on burnout has identified both institutional factors and personal factors. This study suggests that strategies to address both, simultaneously, are needed to truly change the current burnout risk prevalence among surgical trainees. They concluded: “Our findings demonstrate that inherent mindfulness is already in use to combat stress and burnout in surgical trainees and, more importantly, it appears to work. Based on this evidence, mindfulness training can be a critical component of any intervention aimed at enhancing stress resilience and preventing or treating burnout in surgical trainees.”
The researchers reported no relevant financial conflicts.
SOURCE: J Am Coll Surg. 2018 Jan;226(1):80-90. doi: 10.1016/j.jamcollsurg.2017.10.010)
General surgery residents reported high levels of stress linked to burnout, but those who exhibited characteristics of mindfulness were less likely to experience this dynamic, a survey-based study has found.
Carter C. Lebares, MD, of the department of surgery at the University of California, San Francisco, and her colleagues wrote, “Stress is a double-edged sword, with a dose-response relationship between stress and performance described as an ‘inverted U-shaped curve.’ Although stress is initially stimulating, there is a tipping point when demands outstrip resources and stress becomes overwhelming,” the researchers wrote. Surgical trainees purposefully join a high-stress profession and presumably thrive on a demanding environment, but “that does not make individuals immune to the effects of overwhelming stress.”
The investigative team aimed to assess the prevalence and root causes of burnout among surgical trainees. They sent a survey questionnaire to 246 general surgery training program directors and asked them to distribute the survey to their residents (J Am Coll Surg. 2018 Jan;226[1]:80-90. doi: 10.1016/j.jamcollsurg.2017.10.010). The investigators focused on the components of burnout identified in the literature (emotional exhaustion, depersonalization, perceived stress, depression, anxiety, and alcohol misuse/abuse).
The survey, a voluntary and confidential exercise, was based on scales and tools to assess symptoms of burnout (Maslach Burnout Inventory), stress (Cohen’s Perceived Stress Scale), anxiety (Spielberger’s State Trait Anxiety Index), and depression/suicidal ideation (Patient Health Questionnaire).
The researchers also looked at personality traits that could make the difference between the usual stress of residency and burnout in individual trainees. Mindfulness was studied using the Cognitive Affective Mindfulness Scale–Revised. A personality characteristic “trait resilience” was captured in a 10-item Block Ego-Resiliency Scale, which measured ability to adapt to a demanding and changing environment. “Dispositional mindfulness, that is, the innate ability to pay attention to one’s thoughts, emotions, and experiences in a nonreactive way, has been shown to have a buffering effect against perceived stress and burnout among healthcare workers and trainees,” they wrote.
A total of 566 surgery residents responded to the survey; 51% were female and 76% were based in an academic training program. Overall, the survey found that burnout prevalence among general surgery residents was 69%, which confirms the findings of earlier studies of this population, and was significantly higher than rates seen in age-matched peers in the general population and among practicing surgeons. Burnout was equally prevalent among men and women, but men appeared more likely to experience depersonalization (62% vs. 51%). Emotional exhaustion was lower among lab trainees. Alcohol misuse and abuse was somewhat higher in women (58% vs. 41% and 40% vs. 26%, respectively). Although symptoms of burnout were not strongly associated with training level, PGY3 residents experienced the most (58% reported higher stress, 16% suicidal ideation, 50% high anxiety, and 61% alcohol abuse). A high level of stress was reported significantly less often by lab trainees, but alcohol misuse was significantly greater. A high level of stress and emotional exhaustion and depersonalization were strongly linked. And all of these elements were strongly associated with moderate to severe depressive symptoms, suicidal ideation, and high anxiety.
The study is limited by potential biases in the responses, inevitable in a voluntary, self-selected sample. The survey was sent to ACGME-accredited program directors who may or may not have distributed it to their trainees. The investigators suggested that whereas the findings of this study in general confirm earlier research on trainee burnout, the perception of lack personal accomplishment in this sample was less dominant in this sample. “Although this might be because we included residents in lab/research years (widely thought to be a time of very high productivity), it is more likely due to our use of an abbreviated (9-item) form of the Maslach Burnout Inventory-Human Services Survey” and therefore underreported the personal accomplishment factor.
The impact that personality traits (mindfulness and trait resilience) on burnout risk was notable in this sample. “Greater dispositional mindfulness was associated with an 85% decrease in the risk of high stress, and a greater trait resilience was associated with a 65% decrease in the risk of high stress.” Some individuals have traits to help them cope better with stress but the investigators stated that mindfulness and resilience can be taught and fostered in trainees.
The current research on burnout has identified both institutional factors and personal factors. This study suggests that strategies to address both, simultaneously, are needed to truly change the current burnout risk prevalence among surgical trainees. They concluded: “Our findings demonstrate that inherent mindfulness is already in use to combat stress and burnout in surgical trainees and, more importantly, it appears to work. Based on this evidence, mindfulness training can be a critical component of any intervention aimed at enhancing stress resilience and preventing or treating burnout in surgical trainees.”
The researchers reported no relevant financial conflicts.
SOURCE: J Am Coll Surg. 2018 Jan;226(1):80-90. doi: 10.1016/j.jamcollsurg.2017.10.010)
General surgery residents reported high levels of stress linked to burnout, but those who exhibited characteristics of mindfulness were less likely to experience this dynamic, a survey-based study has found.
Carter C. Lebares, MD, of the department of surgery at the University of California, San Francisco, and her colleagues wrote, “Stress is a double-edged sword, with a dose-response relationship between stress and performance described as an ‘inverted U-shaped curve.’ Although stress is initially stimulating, there is a tipping point when demands outstrip resources and stress becomes overwhelming,” the researchers wrote. Surgical trainees purposefully join a high-stress profession and presumably thrive on a demanding environment, but “that does not make individuals immune to the effects of overwhelming stress.”
The investigative team aimed to assess the prevalence and root causes of burnout among surgical trainees. They sent a survey questionnaire to 246 general surgery training program directors and asked them to distribute the survey to their residents (J Am Coll Surg. 2018 Jan;226[1]:80-90. doi: 10.1016/j.jamcollsurg.2017.10.010). The investigators focused on the components of burnout identified in the literature (emotional exhaustion, depersonalization, perceived stress, depression, anxiety, and alcohol misuse/abuse).
The survey, a voluntary and confidential exercise, was based on scales and tools to assess symptoms of burnout (Maslach Burnout Inventory), stress (Cohen’s Perceived Stress Scale), anxiety (Spielberger’s State Trait Anxiety Index), and depression/suicidal ideation (Patient Health Questionnaire).
The researchers also looked at personality traits that could make the difference between the usual stress of residency and burnout in individual trainees. Mindfulness was studied using the Cognitive Affective Mindfulness Scale–Revised. A personality characteristic “trait resilience” was captured in a 10-item Block Ego-Resiliency Scale, which measured ability to adapt to a demanding and changing environment. “Dispositional mindfulness, that is, the innate ability to pay attention to one’s thoughts, emotions, and experiences in a nonreactive way, has been shown to have a buffering effect against perceived stress and burnout among healthcare workers and trainees,” they wrote.
A total of 566 surgery residents responded to the survey; 51% were female and 76% were based in an academic training program. Overall, the survey found that burnout prevalence among general surgery residents was 69%, which confirms the findings of earlier studies of this population, and was significantly higher than rates seen in age-matched peers in the general population and among practicing surgeons. Burnout was equally prevalent among men and women, but men appeared more likely to experience depersonalization (62% vs. 51%). Emotional exhaustion was lower among lab trainees. Alcohol misuse and abuse was somewhat higher in women (58% vs. 41% and 40% vs. 26%, respectively). Although symptoms of burnout were not strongly associated with training level, PGY3 residents experienced the most (58% reported higher stress, 16% suicidal ideation, 50% high anxiety, and 61% alcohol abuse). A high level of stress was reported significantly less often by lab trainees, but alcohol misuse was significantly greater. A high level of stress and emotional exhaustion and depersonalization were strongly linked. And all of these elements were strongly associated with moderate to severe depressive symptoms, suicidal ideation, and high anxiety.
The study is limited by potential biases in the responses, inevitable in a voluntary, self-selected sample. The survey was sent to ACGME-accredited program directors who may or may not have distributed it to their trainees. The investigators suggested that whereas the findings of this study in general confirm earlier research on trainee burnout, the perception of lack personal accomplishment in this sample was less dominant in this sample. “Although this might be because we included residents in lab/research years (widely thought to be a time of very high productivity), it is more likely due to our use of an abbreviated (9-item) form of the Maslach Burnout Inventory-Human Services Survey” and therefore underreported the personal accomplishment factor.
The impact that personality traits (mindfulness and trait resilience) on burnout risk was notable in this sample. “Greater dispositional mindfulness was associated with an 85% decrease in the risk of high stress, and a greater trait resilience was associated with a 65% decrease in the risk of high stress.” Some individuals have traits to help them cope better with stress but the investigators stated that mindfulness and resilience can be taught and fostered in trainees.
The current research on burnout has identified both institutional factors and personal factors. This study suggests that strategies to address both, simultaneously, are needed to truly change the current burnout risk prevalence among surgical trainees. They concluded: “Our findings demonstrate that inherent mindfulness is already in use to combat stress and burnout in surgical trainees and, more importantly, it appears to work. Based on this evidence, mindfulness training can be a critical component of any intervention aimed at enhancing stress resilience and preventing or treating burnout in surgical trainees.”
The researchers reported no relevant financial conflicts.
SOURCE: J Am Coll Surg. 2018 Jan;226(1):80-90. doi: 10.1016/j.jamcollsurg.2017.10.010)
FROM JOURNAL OF THE AMERICAN COLLEGE OF SURGERY
Key clinical point: Burnout prevalence is high among surgical trainees, but individual traits such as mindfulness are linked to a lower risk of burnout.
Major finding: Among surgery residents, the total prevalence of burnout was 69%.
Study details: 566 responses to a voluntary and confidential survey of general surgery residents.
Disclosures: Investigators had no relevant financial disclosures.
Source: J Am Coll Surg. 2018 Jan;226(1):80-90. doi: 10.1016/j.jamcollsurg.2017.10.010.
Sneak Peek: The Hospital Leader blog – Dec. 2017
Cultivating women leaders in health care #WIMmonth #ThisIsWhatADoctorLooksLike
On my flight home from Scotland, I had a moment to watch a movie while my daughter was caught up in the encore adventures of Moana. I stumbled upon “Hidden Figures,” the story of the African American women at NASA who helped launch John Glenn into space, reviving the nation’s space program.
Turns out I wasn’t the only one who stumbled upon this. Harvard researcher Julie Silver, MD, raised the question about invisible women leaders when reviewing quotes in magazines like Modern Healthcare or Forbes. Moreover, her research demonstrates that, for many professional society awards, 0% are given to women! This is happening in specialties that had nearly even proportions of women and men in practice, such as dermatology and rehab medicine. Last month, I was dumbfounded when I saw a full-page New York Times ad of Top Surgeons by Castle Connolly featuring 16 surgeons, all male.
While Castle Connolly does name female top doctors and market ad opportunities to women and men, I learned that only men sign up for the ads. While this raises more questions, the optics remain problematic – women doctors are hidden. Regardless of the venue, we must do a better job profiling our female leaders. In addition, it is important to recognize that female leaders face well-documented and somewhat controversial challenges that require careful thought:
- Stereotype threat: Some of the original research on stereotype threat done in college students showed that, if women who are about to take a math test are told that the test will expose gender differences, such as men do better at math, women will perform worse AND men will do better. The threat of stereotypes is that women can internalize them and this may hamper their progress. The good news is that education on stereotype threat apparently helps.
- Impostor syndrome: Even highly successful people apparently suffer from impostor syndrome, the fear that they do not deserve their success, but it is much worse in women than in men. You are always trying to conquer the little voice in your head that tells you that you are not good enough.
Read the full post at hospitalleader.org.
Also on The Hospital Leader …
- If I were you, I would not be bullish on long-term care by Brad Flansbaum, DO, MPH, MHM
- Da Vinci wuz here by Jordan Messler, MD, SFHM
- Making the implicit explicit by Leslie Flores, MHA, SFHM
- Should we really focus on “patient-centered care”? by Tracy Cardin, ACNP-BC, SFHM
Cultivating women leaders in health care #WIMmonth #ThisIsWhatADoctorLooksLike
On my flight home from Scotland, I had a moment to watch a movie while my daughter was caught up in the encore adventures of Moana. I stumbled upon “Hidden Figures,” the story of the African American women at NASA who helped launch John Glenn into space, reviving the nation’s space program.
Turns out I wasn’t the only one who stumbled upon this. Harvard researcher Julie Silver, MD, raised the question about invisible women leaders when reviewing quotes in magazines like Modern Healthcare or Forbes. Moreover, her research demonstrates that, for many professional society awards, 0% are given to women! This is happening in specialties that had nearly even proportions of women and men in practice, such as dermatology and rehab medicine. Last month, I was dumbfounded when I saw a full-page New York Times ad of Top Surgeons by Castle Connolly featuring 16 surgeons, all male.
While Castle Connolly does name female top doctors and market ad opportunities to women and men, I learned that only men sign up for the ads. While this raises more questions, the optics remain problematic – women doctors are hidden. Regardless of the venue, we must do a better job profiling our female leaders. In addition, it is important to recognize that female leaders face well-documented and somewhat controversial challenges that require careful thought:
- Stereotype threat: Some of the original research on stereotype threat done in college students showed that, if women who are about to take a math test are told that the test will expose gender differences, such as men do better at math, women will perform worse AND men will do better. The threat of stereotypes is that women can internalize them and this may hamper their progress. The good news is that education on stereotype threat apparently helps.
- Impostor syndrome: Even highly successful people apparently suffer from impostor syndrome, the fear that they do not deserve their success, but it is much worse in women than in men. You are always trying to conquer the little voice in your head that tells you that you are not good enough.
Read the full post at hospitalleader.org.
Also on The Hospital Leader …
- If I were you, I would not be bullish on long-term care by Brad Flansbaum, DO, MPH, MHM
- Da Vinci wuz here by Jordan Messler, MD, SFHM
- Making the implicit explicit by Leslie Flores, MHA, SFHM
- Should we really focus on “patient-centered care”? by Tracy Cardin, ACNP-BC, SFHM
Cultivating women leaders in health care #WIMmonth #ThisIsWhatADoctorLooksLike
On my flight home from Scotland, I had a moment to watch a movie while my daughter was caught up in the encore adventures of Moana. I stumbled upon “Hidden Figures,” the story of the African American women at NASA who helped launch John Glenn into space, reviving the nation’s space program.
Turns out I wasn’t the only one who stumbled upon this. Harvard researcher Julie Silver, MD, raised the question about invisible women leaders when reviewing quotes in magazines like Modern Healthcare or Forbes. Moreover, her research demonstrates that, for many professional society awards, 0% are given to women! This is happening in specialties that had nearly even proportions of women and men in practice, such as dermatology and rehab medicine. Last month, I was dumbfounded when I saw a full-page New York Times ad of Top Surgeons by Castle Connolly featuring 16 surgeons, all male.
While Castle Connolly does name female top doctors and market ad opportunities to women and men, I learned that only men sign up for the ads. While this raises more questions, the optics remain problematic – women doctors are hidden. Regardless of the venue, we must do a better job profiling our female leaders. In addition, it is important to recognize that female leaders face well-documented and somewhat controversial challenges that require careful thought:
- Stereotype threat: Some of the original research on stereotype threat done in college students showed that, if women who are about to take a math test are told that the test will expose gender differences, such as men do better at math, women will perform worse AND men will do better. The threat of stereotypes is that women can internalize them and this may hamper their progress. The good news is that education on stereotype threat apparently helps.
- Impostor syndrome: Even highly successful people apparently suffer from impostor syndrome, the fear that they do not deserve their success, but it is much worse in women than in men. You are always trying to conquer the little voice in your head that tells you that you are not good enough.
Read the full post at hospitalleader.org.
Also on The Hospital Leader …
- If I were you, I would not be bullish on long-term care by Brad Flansbaum, DO, MPH, MHM
- Da Vinci wuz here by Jordan Messler, MD, SFHM
- Making the implicit explicit by Leslie Flores, MHA, SFHM
- Should we really focus on “patient-centered care”? by Tracy Cardin, ACNP-BC, SFHM
Massachusetts and the opioid crisis: Can involuntary holds work?
My son played on a neighborhood little league team for several years. I have such sweet memories of little boys in baseball uniforms lined up on the bench singing cheers while they waited their turns to go to bat. The two devoted dads who worked together coaching the team were a gentle presence in the background of my family’s life every spring for years. One might hope that the love and attention those fathers invested in their sons and their teammates might confer some special protection from life’s tragedies, but the opioid epidemic spares no hostages, and last year, one of those singing little boys from so many years ago – the son of one of the coaches – died of a drug overdose.
President Trump has punted on how to stop the epidemic, one he finally deemed a national public health emergency in October, with no clear addition of federal resources. States have varied in their responses, and Massachusetts, in particular, has been aggressive with new legislation and funding. The laws in Massachusetts allow for involuntary rehab for substance abusers if a family member petitions the court under the state’s decades-old section 35. The irony is that much of this “involuntary” treatment is voluntary: People will ask family members to apply for them as a way of getting into treatment and as a way of bypassing the cost. Section 35 admissions are funded by the state, not by the individual or by health insurance.
As a Boston Globe article (“Mass. governor aims to expand battle against opioid addiction,” Nov. 15, 2017) explains, “Two years ago, Baker stirred controversy with a proposal to hold addicted patients for 72 hours against their will in emergency departments. That idea was rejected by the Legislature. The new bill takes a different approach to the 72-hour hold, enabling doctors to transfer patients with addiction to a treatment facility, much as they would with a person deemed a danger because of mental illness.”
The issues with involuntary care are complicated and nuanced in psychiatric disorders, and perhaps even more so with substance abuse. The time frame of 72 hours for mental health conditions allows for assessment and sometimes for the start of treatment. In some states, a hearing must be held for continued involuntary detention; in other states, a decision must be made as to whether further inpatient care will be pursued, and the actual hearing takes place days to weeks later, depending on the state. For the purposes of allowing someone to clear from an opioid intoxication, then persuading them to engage in voluntary substance abuse treatment, it seems that 72 hours could be the exact wrong time period.
Ideally, a patient would be placed in a comfortable inpatient unit, begun on medication-assisted withdrawal, and offered a high quality of care for those 72 hours so that continuing with treatment might be a palatable option. But would that actually happen? Does Massachusetts have the means and facilities for all its overdose patients? Massachusetts has, in fact, been aggressive with funding. Since 2015, the state has added 1,100 new treatment beds. The efforts to fund and offer novel treatments are commendable. My concern remains that without adequate treatment or a positive experience – a difficult target in the best of circumstances for a patient who is 72 hours into opioid withdrawal – patients would leave only to resume their substance abuse. In a disastrous scenario, patients who have overdosed and fear being detained might not call for help, and the death rate could actually rise.
John A. Renner Jr., MD, is the past president of the American Academy of Addiction Psychiatry and coeditor of Office-Based Buprenorphine Treatment of Opioid Use Disorder (American Psychiatric Association Publishing, 2018). Dr. Renner, who is a professor at Boston University, said, “I would like to see some evidence and research to be sure there were not unintended harms before we go this route.”
Eric C. Strain, MD, director of the Johns Hopkins Center for Substance Abuse Treatment and Research, Baltimore, noted: “Simply holding someone for 3 days, especially against their will, doesn’t make a lot of sense. They are certainly not going to be all better either from a physiological or psychological standpoint. It might, however, be possible to get a person who was not interested in treatment engaged in treatment, and that would be a success.”
Despite the increased numbers of beds and aggressive, thoughtful interventions, Massachusetts still had 1,450 overdose deaths in the first 9 months of 2017, a decrease of only 10% from the year before, according to the Globe article. For the sake of the former Little League players in Maryland, and all the other victims of this lethal nationwide epidemic, it is imperative that any untested treatments be the source of new research. If these measures are implemented, it is essential that Massachusetts follow the people who are the beneficiaries of interventions and create the data that allow other states to either follow suit if these efforts are successful, or allocate resources to other treatments if they are not.
Dr. Miller is coauthor with Annette Hanson, MD, of Committed: The Battle Over Involuntary Psychiatry Care (Baltimore: Johns Hopkins University Press, 2016).
My son played on a neighborhood little league team for several years. I have such sweet memories of little boys in baseball uniforms lined up on the bench singing cheers while they waited their turns to go to bat. The two devoted dads who worked together coaching the team were a gentle presence in the background of my family’s life every spring for years. One might hope that the love and attention those fathers invested in their sons and their teammates might confer some special protection from life’s tragedies, but the opioid epidemic spares no hostages, and last year, one of those singing little boys from so many years ago – the son of one of the coaches – died of a drug overdose.
President Trump has punted on how to stop the epidemic, one he finally deemed a national public health emergency in October, with no clear addition of federal resources. States have varied in their responses, and Massachusetts, in particular, has been aggressive with new legislation and funding. The laws in Massachusetts allow for involuntary rehab for substance abusers if a family member petitions the court under the state’s decades-old section 35. The irony is that much of this “involuntary” treatment is voluntary: People will ask family members to apply for them as a way of getting into treatment and as a way of bypassing the cost. Section 35 admissions are funded by the state, not by the individual or by health insurance.
As a Boston Globe article (“Mass. governor aims to expand battle against opioid addiction,” Nov. 15, 2017) explains, “Two years ago, Baker stirred controversy with a proposal to hold addicted patients for 72 hours against their will in emergency departments. That idea was rejected by the Legislature. The new bill takes a different approach to the 72-hour hold, enabling doctors to transfer patients with addiction to a treatment facility, much as they would with a person deemed a danger because of mental illness.”
The issues with involuntary care are complicated and nuanced in psychiatric disorders, and perhaps even more so with substance abuse. The time frame of 72 hours for mental health conditions allows for assessment and sometimes for the start of treatment. In some states, a hearing must be held for continued involuntary detention; in other states, a decision must be made as to whether further inpatient care will be pursued, and the actual hearing takes place days to weeks later, depending on the state. For the purposes of allowing someone to clear from an opioid intoxication, then persuading them to engage in voluntary substance abuse treatment, it seems that 72 hours could be the exact wrong time period.
Ideally, a patient would be placed in a comfortable inpatient unit, begun on medication-assisted withdrawal, and offered a high quality of care for those 72 hours so that continuing with treatment might be a palatable option. But would that actually happen? Does Massachusetts have the means and facilities for all its overdose patients? Massachusetts has, in fact, been aggressive with funding. Since 2015, the state has added 1,100 new treatment beds. The efforts to fund and offer novel treatments are commendable. My concern remains that without adequate treatment or a positive experience – a difficult target in the best of circumstances for a patient who is 72 hours into opioid withdrawal – patients would leave only to resume their substance abuse. In a disastrous scenario, patients who have overdosed and fear being detained might not call for help, and the death rate could actually rise.
John A. Renner Jr., MD, is the past president of the American Academy of Addiction Psychiatry and coeditor of Office-Based Buprenorphine Treatment of Opioid Use Disorder (American Psychiatric Association Publishing, 2018). Dr. Renner, who is a professor at Boston University, said, “I would like to see some evidence and research to be sure there were not unintended harms before we go this route.”
Eric C. Strain, MD, director of the Johns Hopkins Center for Substance Abuse Treatment and Research, Baltimore, noted: “Simply holding someone for 3 days, especially against their will, doesn’t make a lot of sense. They are certainly not going to be all better either from a physiological or psychological standpoint. It might, however, be possible to get a person who was not interested in treatment engaged in treatment, and that would be a success.”
Despite the increased numbers of beds and aggressive, thoughtful interventions, Massachusetts still had 1,450 overdose deaths in the first 9 months of 2017, a decrease of only 10% from the year before, according to the Globe article. For the sake of the former Little League players in Maryland, and all the other victims of this lethal nationwide epidemic, it is imperative that any untested treatments be the source of new research. If these measures are implemented, it is essential that Massachusetts follow the people who are the beneficiaries of interventions and create the data that allow other states to either follow suit if these efforts are successful, or allocate resources to other treatments if they are not.
Dr. Miller is coauthor with Annette Hanson, MD, of Committed: The Battle Over Involuntary Psychiatry Care (Baltimore: Johns Hopkins University Press, 2016).
My son played on a neighborhood little league team for several years. I have such sweet memories of little boys in baseball uniforms lined up on the bench singing cheers while they waited their turns to go to bat. The two devoted dads who worked together coaching the team were a gentle presence in the background of my family’s life every spring for years. One might hope that the love and attention those fathers invested in their sons and their teammates might confer some special protection from life’s tragedies, but the opioid epidemic spares no hostages, and last year, one of those singing little boys from so many years ago – the son of one of the coaches – died of a drug overdose.
President Trump has punted on how to stop the epidemic, one he finally deemed a national public health emergency in October, with no clear addition of federal resources. States have varied in their responses, and Massachusetts, in particular, has been aggressive with new legislation and funding. The laws in Massachusetts allow for involuntary rehab for substance abusers if a family member petitions the court under the state’s decades-old section 35. The irony is that much of this “involuntary” treatment is voluntary: People will ask family members to apply for them as a way of getting into treatment and as a way of bypassing the cost. Section 35 admissions are funded by the state, not by the individual or by health insurance.
As a Boston Globe article (“Mass. governor aims to expand battle against opioid addiction,” Nov. 15, 2017) explains, “Two years ago, Baker stirred controversy with a proposal to hold addicted patients for 72 hours against their will in emergency departments. That idea was rejected by the Legislature. The new bill takes a different approach to the 72-hour hold, enabling doctors to transfer patients with addiction to a treatment facility, much as they would with a person deemed a danger because of mental illness.”
The issues with involuntary care are complicated and nuanced in psychiatric disorders, and perhaps even more so with substance abuse. The time frame of 72 hours for mental health conditions allows for assessment and sometimes for the start of treatment. In some states, a hearing must be held for continued involuntary detention; in other states, a decision must be made as to whether further inpatient care will be pursued, and the actual hearing takes place days to weeks later, depending on the state. For the purposes of allowing someone to clear from an opioid intoxication, then persuading them to engage in voluntary substance abuse treatment, it seems that 72 hours could be the exact wrong time period.
Ideally, a patient would be placed in a comfortable inpatient unit, begun on medication-assisted withdrawal, and offered a high quality of care for those 72 hours so that continuing with treatment might be a palatable option. But would that actually happen? Does Massachusetts have the means and facilities for all its overdose patients? Massachusetts has, in fact, been aggressive with funding. Since 2015, the state has added 1,100 new treatment beds. The efforts to fund and offer novel treatments are commendable. My concern remains that without adequate treatment or a positive experience – a difficult target in the best of circumstances for a patient who is 72 hours into opioid withdrawal – patients would leave only to resume their substance abuse. In a disastrous scenario, patients who have overdosed and fear being detained might not call for help, and the death rate could actually rise.
John A. Renner Jr., MD, is the past president of the American Academy of Addiction Psychiatry and coeditor of Office-Based Buprenorphine Treatment of Opioid Use Disorder (American Psychiatric Association Publishing, 2018). Dr. Renner, who is a professor at Boston University, said, “I would like to see some evidence and research to be sure there were not unintended harms before we go this route.”
Eric C. Strain, MD, director of the Johns Hopkins Center for Substance Abuse Treatment and Research, Baltimore, noted: “Simply holding someone for 3 days, especially against their will, doesn’t make a lot of sense. They are certainly not going to be all better either from a physiological or psychological standpoint. It might, however, be possible to get a person who was not interested in treatment engaged in treatment, and that would be a success.”
Despite the increased numbers of beds and aggressive, thoughtful interventions, Massachusetts still had 1,450 overdose deaths in the first 9 months of 2017, a decrease of only 10% from the year before, according to the Globe article. For the sake of the former Little League players in Maryland, and all the other victims of this lethal nationwide epidemic, it is imperative that any untested treatments be the source of new research. If these measures are implemented, it is essential that Massachusetts follow the people who are the beneficiaries of interventions and create the data that allow other states to either follow suit if these efforts are successful, or allocate resources to other treatments if they are not.
Dr. Miller is coauthor with Annette Hanson, MD, of Committed: The Battle Over Involuntary Psychiatry Care (Baltimore: Johns Hopkins University Press, 2016).
Laparoscopic nerve-sparing approach is effective in deep infiltrating endometriosis
NATIONAL HARBOR, MD. – Laparoscopic retroperitoneal nerve-sparing surgery is a safe approach that relieves pain in women with deep infiltrating endometriosis, according to findings presented by Giovanni Roviglione, MD, at the AAGL Global Congress.
The prospective case series study with a single gynecologic surgeon in Verona, Italy, involved 382 women who had deep infiltrating endometriosis with sciatica and anogenital pain. All of the women had some level of nervous compression of somatic structures and infiltration of their fascial envelope.
The surgery involved whole decompression and partial neurolysis of nervous structures for most patients, while nearly 20% of women required complete neurolysis based on their level of infiltration. Most women (64%) had severe enough infiltration that a concomitant bowel resection was also necessary.
The surgeon performed a medial approach for deep pelvic endometriosis with rectal and/or parametrial involvement extending to the pelvic wall and somatic nerve, or a lateral approach for isolated endometriosis of the pelvic wall and somatic nerves.
At 6 months after surgery, all patients reported complete relief from pain. However, 77 women (20%) experienced postoperative neuritis, which was successfully treated with corticosteroids, antiepileptics, and opioids.
Endometriosis that extends into somatic nerves and the sacral roots is a common cause of pelvic pain, Dr. Roviglione said.
“This kind of endometriosis is resistant to opioids and drugs,” he said. The difficulty in treating deep infiltrating endometriosis is compounded by the often long delay in diagnosis, he added.
Using laparoscopy for neurolysis and decompression of somatic nerves affected by endometriosis is a “more accurate and effective treatment” for providing pain relief, Dr. Roviglione said. But laparoscopic retroperitoneal nerve-sparing surgery should be performed only by skilled neuroanatomy surgeons at referral centers because of the complex nature of the procedure, he noted.
Dr. Roviglione reported having no relevant financial disclosures.
SOURCE: Ceccaroni M et al. AAGL 2017 Abstract 166.
NATIONAL HARBOR, MD. – Laparoscopic retroperitoneal nerve-sparing surgery is a safe approach that relieves pain in women with deep infiltrating endometriosis, according to findings presented by Giovanni Roviglione, MD, at the AAGL Global Congress.
The prospective case series study with a single gynecologic surgeon in Verona, Italy, involved 382 women who had deep infiltrating endometriosis with sciatica and anogenital pain. All of the women had some level of nervous compression of somatic structures and infiltration of their fascial envelope.
The surgery involved whole decompression and partial neurolysis of nervous structures for most patients, while nearly 20% of women required complete neurolysis based on their level of infiltration. Most women (64%) had severe enough infiltration that a concomitant bowel resection was also necessary.
The surgeon performed a medial approach for deep pelvic endometriosis with rectal and/or parametrial involvement extending to the pelvic wall and somatic nerve, or a lateral approach for isolated endometriosis of the pelvic wall and somatic nerves.
At 6 months after surgery, all patients reported complete relief from pain. However, 77 women (20%) experienced postoperative neuritis, which was successfully treated with corticosteroids, antiepileptics, and opioids.
Endometriosis that extends into somatic nerves and the sacral roots is a common cause of pelvic pain, Dr. Roviglione said.
“This kind of endometriosis is resistant to opioids and drugs,” he said. The difficulty in treating deep infiltrating endometriosis is compounded by the often long delay in diagnosis, he added.
Using laparoscopy for neurolysis and decompression of somatic nerves affected by endometriosis is a “more accurate and effective treatment” for providing pain relief, Dr. Roviglione said. But laparoscopic retroperitoneal nerve-sparing surgery should be performed only by skilled neuroanatomy surgeons at referral centers because of the complex nature of the procedure, he noted.
Dr. Roviglione reported having no relevant financial disclosures.
SOURCE: Ceccaroni M et al. AAGL 2017 Abstract 166.
NATIONAL HARBOR, MD. – Laparoscopic retroperitoneal nerve-sparing surgery is a safe approach that relieves pain in women with deep infiltrating endometriosis, according to findings presented by Giovanni Roviglione, MD, at the AAGL Global Congress.
The prospective case series study with a single gynecologic surgeon in Verona, Italy, involved 382 women who had deep infiltrating endometriosis with sciatica and anogenital pain. All of the women had some level of nervous compression of somatic structures and infiltration of their fascial envelope.
The surgery involved whole decompression and partial neurolysis of nervous structures for most patients, while nearly 20% of women required complete neurolysis based on their level of infiltration. Most women (64%) had severe enough infiltration that a concomitant bowel resection was also necessary.
The surgeon performed a medial approach for deep pelvic endometriosis with rectal and/or parametrial involvement extending to the pelvic wall and somatic nerve, or a lateral approach for isolated endometriosis of the pelvic wall and somatic nerves.
At 6 months after surgery, all patients reported complete relief from pain. However, 77 women (20%) experienced postoperative neuritis, which was successfully treated with corticosteroids, antiepileptics, and opioids.
Endometriosis that extends into somatic nerves and the sacral roots is a common cause of pelvic pain, Dr. Roviglione said.
“This kind of endometriosis is resistant to opioids and drugs,” he said. The difficulty in treating deep infiltrating endometriosis is compounded by the often long delay in diagnosis, he added.
Using laparoscopy for neurolysis and decompression of somatic nerves affected by endometriosis is a “more accurate and effective treatment” for providing pain relief, Dr. Roviglione said. But laparoscopic retroperitoneal nerve-sparing surgery should be performed only by skilled neuroanatomy surgeons at referral centers because of the complex nature of the procedure, he noted.
Dr. Roviglione reported having no relevant financial disclosures.
SOURCE: Ceccaroni M et al. AAGL 2017 Abstract 166.
REPORTING FROM AAGL 2017
Key clinical point:
Major finding: All patients reported complete relief of neurologic symptoms at 6 months after surgery.
Study details: Single center, prospective case series of 382 women who underwent laparoscopic retroperitoneal nerve-sparing surgery to treat pain associated with deep infiltrating endometriosis.
Disclosures: Dr. Roviglione reported having no relevant financial disclosures.
Source: Ceccaroni M et al. AAGL 2017 Abstract 166.
Enzalutamide plus exemestane improves PFS in HR+ breast cancer subset
SAN ANTONIO – Enzalutamide added to exemestane improved progression-free survival (PFS) in patients with hormone receptor (HR)-positive advanced breast cancer, investigators reported.
Specifically, it improved outcomes in patients who had not received any prior endocrine therapy and who were positive for a gene signature-based biomarker indicating androgen receptor (AR) signaling.
Patients in this subset who were treated with combination enzalutamide and exemestane achieved a median PFS of 16.5 months, which was significantly higher than the 4 months observed with placebo and exemestane.
However, the addition of enzalutamide had no effect on PFS in the overall cohort or among patients who were biomarker positive but who had received prior endocrine therapy.
“The study met its primary endpoint in improving PFS in the enzalutamide plus exemestane-treated patients who were biomarker positive and HR positive with no prior endocrine therapy for advanced disease as compared [with] exemestane alone,” Denise A. Yardley, MD, of Tennessee Oncology, Nashville, said at the San Antonio Breast Cancer Symposium.
“The role of the AR in HR-positive breast cancer and the predictive value of the identified biomarker are still unclear and will require further studies and validation,” said Dr. Yardley.
Targeting AR is an active area of breast cancer research, as a majority of HR-positive tumors express the AR, as do a moderate number of HER2-positive tumors and almost a third of triple-negative breast cancers. AR signaling has also been associated with resistance to endocrine therapy. Aromatase inhibitors divert estrogen precursors to androgens and data from preclinical models have shown that enzalutamide blocked both estrogen- and androgen-mediated growth of HR+ cells.
Enzalutamide is an inhibitor of AR signaling that is currently used to treat patients with castration-resistant prostate cancer, and has demonstrated clinical activity and was well tolerated in patients with AR-positive advanced triple negative breast cancer, explained Dr. Yardley.
In this study, Dr. Yardley and her colleagues conducted a placebo-controlled phase 2 randomized trial that included 247 patients with HR+/HER2-normal advanced/metastatic breast cancer who were assigned to either 25 mg exemestane plus placebo or 50 mg exemestane and 160 mg enzalutamide daily.
The patients were divided into two parallel cohorts: those with no prior endocrine therapy (C1; n = 127) or those who had received one prior endocrine therapy for metastatic disease (C2; n = 120).
The primary endpoint was PFS in the intent-to-treat population and in the biomarker subgroup of each cohort. Secondary endpoints included the clinical benefit rate at 24 weeks, best overall response, and safety.
The authors found that the PFS in the intent-to-treat population did not significantly differ between those randomized to enzalutamide or placebo in either cohort. In cohort 1, the median PFS was 11.8 months in the enzalutamide arm and 5.8 months in the placebo arm (hazard ratio, 0.82; P = .3631), and in cohort 2, 3.6 months and 3.9 months, respectively (HR, 1.02; P = .9212).
However, statistically significant improvements in median PFS and clinical benefit rate at 24 weeks were observed only in the group with a positive biomarker who had not received any prior endocrine therapy. In cohort 1, the median PFS was 16.5 months in the enzalutamide arm vs. 4.3 months in the placebo arm (HR, 0.44, P = .0335). In cohort 2, median PFS did not significantly differ between groups (6.0 vs. 5.3 months; HR, 0.55; P = .1936).
The clinical response rate in cohort 1 of the biomarker positive group was 83% in the enzalutamide arm versus 38% in the placebo arm (P = .0012).
Adverse events with enzalutamide was similar to those previously reported, and the most common were nausea (39%) in cohort 1 and fatigue (37%) in cohort 2. Dose interruptions due to adverse events occurred in 21.0% and 25.0% of patients randomized to enzalutamide in cohorts 1 and 2 vs. 20.6% and 15.0% in the placebo group.
Dr. Yardley explained that the biomarker used in the study was identified on PAM50. “It was exploratory and proprietary,” she noted, adding that she is unable to share any further information about it at this time.
SOURCE: Yardley et al. SABCS Abstract GS4-07
SAN ANTONIO – Enzalutamide added to exemestane improved progression-free survival (PFS) in patients with hormone receptor (HR)-positive advanced breast cancer, investigators reported.
Specifically, it improved outcomes in patients who had not received any prior endocrine therapy and who were positive for a gene signature-based biomarker indicating androgen receptor (AR) signaling.
Patients in this subset who were treated with combination enzalutamide and exemestane achieved a median PFS of 16.5 months, which was significantly higher than the 4 months observed with placebo and exemestane.
However, the addition of enzalutamide had no effect on PFS in the overall cohort or among patients who were biomarker positive but who had received prior endocrine therapy.
“The study met its primary endpoint in improving PFS in the enzalutamide plus exemestane-treated patients who were biomarker positive and HR positive with no prior endocrine therapy for advanced disease as compared [with] exemestane alone,” Denise A. Yardley, MD, of Tennessee Oncology, Nashville, said at the San Antonio Breast Cancer Symposium.
“The role of the AR in HR-positive breast cancer and the predictive value of the identified biomarker are still unclear and will require further studies and validation,” said Dr. Yardley.
Targeting AR is an active area of breast cancer research, as a majority of HR-positive tumors express the AR, as do a moderate number of HER2-positive tumors and almost a third of triple-negative breast cancers. AR signaling has also been associated with resistance to endocrine therapy. Aromatase inhibitors divert estrogen precursors to androgens and data from preclinical models have shown that enzalutamide blocked both estrogen- and androgen-mediated growth of HR+ cells.
Enzalutamide is an inhibitor of AR signaling that is currently used to treat patients with castration-resistant prostate cancer, and has demonstrated clinical activity and was well tolerated in patients with AR-positive advanced triple negative breast cancer, explained Dr. Yardley.
In this study, Dr. Yardley and her colleagues conducted a placebo-controlled phase 2 randomized trial that included 247 patients with HR+/HER2-normal advanced/metastatic breast cancer who were assigned to either 25 mg exemestane plus placebo or 50 mg exemestane and 160 mg enzalutamide daily.
The patients were divided into two parallel cohorts: those with no prior endocrine therapy (C1; n = 127) or those who had received one prior endocrine therapy for metastatic disease (C2; n = 120).
The primary endpoint was PFS in the intent-to-treat population and in the biomarker subgroup of each cohort. Secondary endpoints included the clinical benefit rate at 24 weeks, best overall response, and safety.
The authors found that the PFS in the intent-to-treat population did not significantly differ between those randomized to enzalutamide or placebo in either cohort. In cohort 1, the median PFS was 11.8 months in the enzalutamide arm and 5.8 months in the placebo arm (hazard ratio, 0.82; P = .3631), and in cohort 2, 3.6 months and 3.9 months, respectively (HR, 1.02; P = .9212).
However, statistically significant improvements in median PFS and clinical benefit rate at 24 weeks were observed only in the group with a positive biomarker who had not received any prior endocrine therapy. In cohort 1, the median PFS was 16.5 months in the enzalutamide arm vs. 4.3 months in the placebo arm (HR, 0.44, P = .0335). In cohort 2, median PFS did not significantly differ between groups (6.0 vs. 5.3 months; HR, 0.55; P = .1936).
The clinical response rate in cohort 1 of the biomarker positive group was 83% in the enzalutamide arm versus 38% in the placebo arm (P = .0012).
Adverse events with enzalutamide was similar to those previously reported, and the most common were nausea (39%) in cohort 1 and fatigue (37%) in cohort 2. Dose interruptions due to adverse events occurred in 21.0% and 25.0% of patients randomized to enzalutamide in cohorts 1 and 2 vs. 20.6% and 15.0% in the placebo group.
Dr. Yardley explained that the biomarker used in the study was identified on PAM50. “It was exploratory and proprietary,” she noted, adding that she is unable to share any further information about it at this time.
SOURCE: Yardley et al. SABCS Abstract GS4-07
SAN ANTONIO – Enzalutamide added to exemestane improved progression-free survival (PFS) in patients with hormone receptor (HR)-positive advanced breast cancer, investigators reported.
Specifically, it improved outcomes in patients who had not received any prior endocrine therapy and who were positive for a gene signature-based biomarker indicating androgen receptor (AR) signaling.
Patients in this subset who were treated with combination enzalutamide and exemestane achieved a median PFS of 16.5 months, which was significantly higher than the 4 months observed with placebo and exemestane.
However, the addition of enzalutamide had no effect on PFS in the overall cohort or among patients who were biomarker positive but who had received prior endocrine therapy.
“The study met its primary endpoint in improving PFS in the enzalutamide plus exemestane-treated patients who were biomarker positive and HR positive with no prior endocrine therapy for advanced disease as compared [with] exemestane alone,” Denise A. Yardley, MD, of Tennessee Oncology, Nashville, said at the San Antonio Breast Cancer Symposium.
“The role of the AR in HR-positive breast cancer and the predictive value of the identified biomarker are still unclear and will require further studies and validation,” said Dr. Yardley.
Targeting AR is an active area of breast cancer research, as a majority of HR-positive tumors express the AR, as do a moderate number of HER2-positive tumors and almost a third of triple-negative breast cancers. AR signaling has also been associated with resistance to endocrine therapy. Aromatase inhibitors divert estrogen precursors to androgens and data from preclinical models have shown that enzalutamide blocked both estrogen- and androgen-mediated growth of HR+ cells.
Enzalutamide is an inhibitor of AR signaling that is currently used to treat patients with castration-resistant prostate cancer, and has demonstrated clinical activity and was well tolerated in patients with AR-positive advanced triple negative breast cancer, explained Dr. Yardley.
In this study, Dr. Yardley and her colleagues conducted a placebo-controlled phase 2 randomized trial that included 247 patients with HR+/HER2-normal advanced/metastatic breast cancer who were assigned to either 25 mg exemestane plus placebo or 50 mg exemestane and 160 mg enzalutamide daily.
The patients were divided into two parallel cohorts: those with no prior endocrine therapy (C1; n = 127) or those who had received one prior endocrine therapy for metastatic disease (C2; n = 120).
The primary endpoint was PFS in the intent-to-treat population and in the biomarker subgroup of each cohort. Secondary endpoints included the clinical benefit rate at 24 weeks, best overall response, and safety.
The authors found that the PFS in the intent-to-treat population did not significantly differ between those randomized to enzalutamide or placebo in either cohort. In cohort 1, the median PFS was 11.8 months in the enzalutamide arm and 5.8 months in the placebo arm (hazard ratio, 0.82; P = .3631), and in cohort 2, 3.6 months and 3.9 months, respectively (HR, 1.02; P = .9212).
However, statistically significant improvements in median PFS and clinical benefit rate at 24 weeks were observed only in the group with a positive biomarker who had not received any prior endocrine therapy. In cohort 1, the median PFS was 16.5 months in the enzalutamide arm vs. 4.3 months in the placebo arm (HR, 0.44, P = .0335). In cohort 2, median PFS did not significantly differ between groups (6.0 vs. 5.3 months; HR, 0.55; P = .1936).
The clinical response rate in cohort 1 of the biomarker positive group was 83% in the enzalutamide arm versus 38% in the placebo arm (P = .0012).
Adverse events with enzalutamide was similar to those previously reported, and the most common were nausea (39%) in cohort 1 and fatigue (37%) in cohort 2. Dose interruptions due to adverse events occurred in 21.0% and 25.0% of patients randomized to enzalutamide in cohorts 1 and 2 vs. 20.6% and 15.0% in the placebo group.
Dr. Yardley explained that the biomarker used in the study was identified on PAM50. “It was exploratory and proprietary,” she noted, adding that she is unable to share any further information about it at this time.
SOURCE: Yardley et al. SABCS Abstract GS4-07
REPORTING FROM SABCS 2017
Key clinical point: Enzalutamide added to exemestane improves progression-free survival in hormone receptor–positive advanced breast cancer patients with a biomarker indicating androgen receptor signaling.
Major finding: In this subset of patients, combination therapy improved PFS: 16.5 months vs. 4.3 months for the placebo arm (HR 0.44, P = .0335).
Data source: A placebo-controlled phase 2 randomized trial comprising 247 patients with HR+/HER2-normal advanced/metastatic breast cancer.
Disclosures: Study funding was not disclosed.
Source: Yardley et al. SABCS Abstract GS4-07.
FDA bans 24 ingredients from OTC health care antiseptic products
in hospital settings and other health care situations outside the hospital, the U.S. Food and Drug Administration announced in a final rule.
The affected products include health care personnel hand washes and hand rubs, surgical hand scrubs and hand rubs, and patient antiseptic skin preparations. The final rule was published Dec. 20 in the Federal Register and becomes effective in December 2018.
The agency determined that a deferral is warranted for six health care antiseptic active ingredients – benzalkonium chloride, benzethonium chloride, chloroxylenol, alcohol, isopropyl alcohol, and povidone-iodine – to allow more time for interested parties to complete the studies necessary to fill the safety and effectiveness data gaps identified for these ingredients.
“The FDA expects that this information may help better inform us on antiseptic resistance and antibiotic cross-resistance in the health care setting,” FDA Commissioner Scott Gottlieb, MD, said in a statement. “Importantly, this doesn’t mean that products containing these six ingredients are ineffective or unsafe. These antiseptic products remain an important resource in health care settings. Personnel should continue to use these products consistent with infection control guidelines while the additional data are gathered.”
No additional data was provided for another 24 products, which were deemed not generally recognized as safe and effective. The minimum data needed to demonstrate safety for all health care antiseptic active ingredients fall into four broad categories: human safety studies, nonclinical safety studies (developmental and reproductive toxicity studies and carcinogenicity studies), data to characterize potential hormonal effects, and data to evaluate the development of antimicrobial resistance, the final rule states.
The FDA noted that manufacturers started to remove nearly all of these 24 active ingredients from their products following a 2015 proposed rule. Triclosan is currently being used in available products.
The active ingredients affected are chlorhexidine gluconate; cloflucarban; fluorosalan; hexachlorophene; hexylresorcinol; iodophors (iodine-containing ingredients including iodine complex [ammonium ether sulfate and polyoxyethylene sorbitan monolaurate], iodine complex [phosphate ester of alkylaryloxy polyethylene glycol], iodine tincture USP, iodine topical solution USP, nonylphenoxypoly [ethyleneoxy] ethanoliodine, poloxamer–iodine complex, undecoylium chloride iodine complex); mercufenol chloride; methylbenzethonium chloride; phenol; secondary amyltricresols; sodium oxychlorosene; tribromsalan; triclocarban; triclosan; triple dye; combination of calomel, oxyquinoline benzoate, triethanolamine, and phenol derivative; and combination of mercufenol chloride and secondary amyltricresols in 50% alcohol.
If manufacturers want to use one or more of these 24 active ingredients in future OTC health care antiseptic drug products, those products will be considered new drugs for which a new drug application approval will be required, the agency said.
The rule does not affect health care antiseptics that are currently marketed under new drug applications and abbreviated new drug applications.
FDA’s action follows a similar final rule published Sept. 6, 2016, which removed triclosan and 18 other active ingredients from consumer antiseptic products.
in hospital settings and other health care situations outside the hospital, the U.S. Food and Drug Administration announced in a final rule.
The affected products include health care personnel hand washes and hand rubs, surgical hand scrubs and hand rubs, and patient antiseptic skin preparations. The final rule was published Dec. 20 in the Federal Register and becomes effective in December 2018.
The agency determined that a deferral is warranted for six health care antiseptic active ingredients – benzalkonium chloride, benzethonium chloride, chloroxylenol, alcohol, isopropyl alcohol, and povidone-iodine – to allow more time for interested parties to complete the studies necessary to fill the safety and effectiveness data gaps identified for these ingredients.
“The FDA expects that this information may help better inform us on antiseptic resistance and antibiotic cross-resistance in the health care setting,” FDA Commissioner Scott Gottlieb, MD, said in a statement. “Importantly, this doesn’t mean that products containing these six ingredients are ineffective or unsafe. These antiseptic products remain an important resource in health care settings. Personnel should continue to use these products consistent with infection control guidelines while the additional data are gathered.”
No additional data was provided for another 24 products, which were deemed not generally recognized as safe and effective. The minimum data needed to demonstrate safety for all health care antiseptic active ingredients fall into four broad categories: human safety studies, nonclinical safety studies (developmental and reproductive toxicity studies and carcinogenicity studies), data to characterize potential hormonal effects, and data to evaluate the development of antimicrobial resistance, the final rule states.
The FDA noted that manufacturers started to remove nearly all of these 24 active ingredients from their products following a 2015 proposed rule. Triclosan is currently being used in available products.
The active ingredients affected are chlorhexidine gluconate; cloflucarban; fluorosalan; hexachlorophene; hexylresorcinol; iodophors (iodine-containing ingredients including iodine complex [ammonium ether sulfate and polyoxyethylene sorbitan monolaurate], iodine complex [phosphate ester of alkylaryloxy polyethylene glycol], iodine tincture USP, iodine topical solution USP, nonylphenoxypoly [ethyleneoxy] ethanoliodine, poloxamer–iodine complex, undecoylium chloride iodine complex); mercufenol chloride; methylbenzethonium chloride; phenol; secondary amyltricresols; sodium oxychlorosene; tribromsalan; triclocarban; triclosan; triple dye; combination of calomel, oxyquinoline benzoate, triethanolamine, and phenol derivative; and combination of mercufenol chloride and secondary amyltricresols in 50% alcohol.
If manufacturers want to use one or more of these 24 active ingredients in future OTC health care antiseptic drug products, those products will be considered new drugs for which a new drug application approval will be required, the agency said.
The rule does not affect health care antiseptics that are currently marketed under new drug applications and abbreviated new drug applications.
FDA’s action follows a similar final rule published Sept. 6, 2016, which removed triclosan and 18 other active ingredients from consumer antiseptic products.
in hospital settings and other health care situations outside the hospital, the U.S. Food and Drug Administration announced in a final rule.
The affected products include health care personnel hand washes and hand rubs, surgical hand scrubs and hand rubs, and patient antiseptic skin preparations. The final rule was published Dec. 20 in the Federal Register and becomes effective in December 2018.
The agency determined that a deferral is warranted for six health care antiseptic active ingredients – benzalkonium chloride, benzethonium chloride, chloroxylenol, alcohol, isopropyl alcohol, and povidone-iodine – to allow more time for interested parties to complete the studies necessary to fill the safety and effectiveness data gaps identified for these ingredients.
“The FDA expects that this information may help better inform us on antiseptic resistance and antibiotic cross-resistance in the health care setting,” FDA Commissioner Scott Gottlieb, MD, said in a statement. “Importantly, this doesn’t mean that products containing these six ingredients are ineffective or unsafe. These antiseptic products remain an important resource in health care settings. Personnel should continue to use these products consistent with infection control guidelines while the additional data are gathered.”
No additional data was provided for another 24 products, which were deemed not generally recognized as safe and effective. The minimum data needed to demonstrate safety for all health care antiseptic active ingredients fall into four broad categories: human safety studies, nonclinical safety studies (developmental and reproductive toxicity studies and carcinogenicity studies), data to characterize potential hormonal effects, and data to evaluate the development of antimicrobial resistance, the final rule states.
The FDA noted that manufacturers started to remove nearly all of these 24 active ingredients from their products following a 2015 proposed rule. Triclosan is currently being used in available products.
The active ingredients affected are chlorhexidine gluconate; cloflucarban; fluorosalan; hexachlorophene; hexylresorcinol; iodophors (iodine-containing ingredients including iodine complex [ammonium ether sulfate and polyoxyethylene sorbitan monolaurate], iodine complex [phosphate ester of alkylaryloxy polyethylene glycol], iodine tincture USP, iodine topical solution USP, nonylphenoxypoly [ethyleneoxy] ethanoliodine, poloxamer–iodine complex, undecoylium chloride iodine complex); mercufenol chloride; methylbenzethonium chloride; phenol; secondary amyltricresols; sodium oxychlorosene; tribromsalan; triclocarban; triclosan; triple dye; combination of calomel, oxyquinoline benzoate, triethanolamine, and phenol derivative; and combination of mercufenol chloride and secondary amyltricresols in 50% alcohol.
If manufacturers want to use one or more of these 24 active ingredients in future OTC health care antiseptic drug products, those products will be considered new drugs for which a new drug application approval will be required, the agency said.
The rule does not affect health care antiseptics that are currently marketed under new drug applications and abbreviated new drug applications.
FDA’s action follows a similar final rule published Sept. 6, 2016, which removed triclosan and 18 other active ingredients from consumer antiseptic products.
Preventing cardiovascular disease in older adults: One size does not fit all
When assessing and attempting to modify the risk of cardiovascular disease in older patients, physicians should consider incorporating the concept of frailty. The balance of risk and benefit may differ considerably for 2 patients of the same age if one is fit and the other is frail. Because the aging population is a diverse group, a one-size-fits-all approach to cardiovascular disease prevention and risk-factor management is not appropriate.
A GROWING, DIVERSE GROUP
The number of older adults with multiple cardiovascular risk factors is increasing as life expectancy improves. US residents who are age 65 today can expect to live to an average age of 84 (men) or 87 (women).1
However, the range of life expectancy for people reaching these advanced ages is wide, and chronologic age is no longer sufficient to determine a patient’s risk profile. Furthermore, the prevalence of cardiovascular disease rises with age, and age itself is the strongest predictor of cardiovascular risk.2
Current risk calculators have not been validated in people over age 80,2 making them inadequate for use in older patients. Age alone cannot identify who will benefit from preventive strategies, except in situations when a dominant disease such as metastatic cancer, end-stage renal disease, end-stage dementia, or end-stage heart failure is expected to lead to mortality within a year. Guidelines for treating common risk factors such as elevated cholesterol3 in the general population have generally not focused on adults over 75 or recognized their diversity in health status.4 In order to generate an individualized prescription for cardiovascular disease prevention for older adults, issues such as frailty, cognitive and functional status, disability, and comorbidity must be considered.
WHAT IS FRAILTY?
Clinicians have recognized frailty for decades, but to date there remains a debate on how to define it.
Clegg et al5 described frailty as “a state of increased vulnerability to poor resolution of homeostasis after a stressor event,”5 a definition generally agreed upon, as frailty predicts both poor health outcomes and death.
Indeed, in a prospective study of 5,317 men and women ranging in age from 65 to 101, those identified as frail at baseline were 6 times more likely to have died 3 years later (mortality rates 18% vs 3%), and the difference persisted at 7 years.6 After adjusting for comorbidities, those identified as frail were also more likely to fall, develop limitations in mobility or activities of daily living, or be hospitalized.
The two current leading theories of frailty were defined by Fried et al6 and by Rockwood and Mitnitski.7
Fried et al6 have operationalized frailty as a “physical phenotype,” defined as 3 or more of the following:
- Unintentional weight loss of 10 pounds in the past year
- Self-reported exhaustion
- Weakness as measured by grip strength
- Slow walking speed
- Decreased physical activity.6
Rockwood and Mitnitski7 define frailty as an accumulation of health-related deficits over time. They recommend that 30 to 40 possible deficits that cover a variety of health systems be included such as cognition, mood, function, and comorbidity. These are added and divided by the total possible number of variables to generate a score between 0 and 1.8
The difficulty in defining frailty has led to varying estimates of its prevalence, ranging from 25% to 50% in adults over 65 who have cardiovascular disease.9
CAUSE AND CONSEQUENCE OF CARDIOVASCULAR DISEASE
Studies have highlighted the bidirectional connection between frailty and cardiovascular disease.10 Frailty may predict cardiovascular disease, while cardiovascular disease is associated with an increased risk of incident frailty.9,11
Frail adults with cardiovascular disease have a higher risk of poor outcomes, even after correcting for age, comorbidities, disability, and disease severity. For example, frailty is associated with a twofold higher mortality rate in individuals with cardiovascular disease.9
A prospective cohort study12 of 3,895 middle-aged men and women demonstrated that those with an elevated cardiovascular risk score were at increased risk of frailty over 10 years (odds ratio [OR] 1.35, 95% confidence interval [CI] 1.21–1.51) and incident cardiovascular events (OR 1.36, 95% CI 1.15–1.61). This suggests that modification of cardiovascular risk factors earlier in life may reduce the risk of subsequently becoming frail.
Biologic mechanisms that may explain the connection between frailty and cardiovascular disease include derangements in inflammatory, hematologic, and endocrine pathways. People who are found to be clinically frail are more likely to have insulin resistance and elevated biomarkers such as C-reactive protein, D-dimer, and factor VIII.13 The inflammatory cytokine interleukin 6 is suggested as a common link between inflammation and thrombosis, perhaps contributing to the connection between cardiovascular disease and frailty. Many of these biomarkers have been linked to the pathophysiologic changes of aging, so-called “inflamm-aging” or immunosenescence, including sarcopenia, osteoporosis, and cardiovascular disease.14
ASSESSING FRAILTY IN THE CLINIC
For adults over age 70, frailty assessment is an important first step in managing cardiovascular disease risk.15 Frailty status will better identify those at risk of adverse outcomes in the short term and those who are most likely to benefit from long-term cardiovascular preventive strategies. Additionally, incorporating frailty assessment into traditional risk factor evaluation may permit appropriate intervention and prevention of a potentially modifiable risk factor.
Gait speed is a quick, easy, inexpensive, and sensitive way to assess frailty status, with excellent inter-rater and test-retest reliability, even in those with cognitive impairment.16 Slow gait speed predicts limitations in mobility, limitations in activities of daily living, and death.8,17
In a prospective study18 of 1,567 men and women, mean age 74, slow gait speed was the strongest predictor of subsequent cardiovascular events.18
Gait speed is usually measured over a distance of 4 meters (13.1 feet),17 and the patient is asked to walk comfortably in an unobstructed, marked area. An assistive walking device can be used if needed. If possible, this is repeated once after a brief recovery period, and the average is recorded.
The FRAIL scale19,20 is a simple, validated questionnaire that combines the Fried and Rockwood concepts of frailty and can be given over the phone or to patients in a waiting room. One point is given for each of the following, and people who have 3 or more are considered frail:
- Fatigue
- Resistance (inability to climb 1 flight of stairs)
- Ambulation (inability to walk 1 block)
- Illnesses (having more than 5)
- Loss of more than 5% of body weight.
Other measures of physical function such as grip strength (using a dynamometer), the Timed Up and Go test (assessing the ability to get up from a chair and walk a short distance), and Short Physical Performance Battery (assessing balance, chair stands, and walking speed) can be used to screen for frailty, but are more time-intensive than gait speed alone, and so are not always practical to use in a busy clinic.21
MANAGEMENT OF RISK FACTORS
Management of cardiovascular risk factors is best individualized as outlined below.
LOWERING HIGH BLOOD PRESSURE
The incidence of ischemic heart disease and stroke increases with age across all levels of elevated systolic and diastolic blood pressure.22 Hypertension is also associated with increased risk of cognitive decline. However, a J-shaped relationship has been observed in older adults, with increased cardiovascular events for both low and elevated blood pressure, although the clinical relevance remains controversial.23
Odden et al24 performed an observational study and found that high blood pressure was associated with an increased mortality rate in older adults with normal gait speed, while in those with slow gait speed, high blood pressure neither harmed nor helped. Those who could not walk 6 meters appeared to benefit from higher blood pressure.
HYVET (the Hypertension in the Very Elderly Trial),25 a randomized controlled trial in 3,845 community-dwelling people age 80 or older with sustained systolic blood pressure higher than 160 mm Hg, found a significant reduction in rates of stroke and all-cause mortality (relative risk [RR] 0.76, P = .007) in the treatment arm using indapamide with perindopril if necessary to reach a target blood pressure of 150/80 mm Hg.
Frailty was not assessed during the trial; however, in a reanalysis, the results did not change in those identified as frail using a Rockwood frailty index (a count of health-related deficits accumulated over the lifespan).26
SPRINT (the Systolic Blood Pressure Intervention Trial)27 randomized participants age 50 and older with systolic blood pressure of 130 to 180 mm Hg and at increased risk of cardiovascular disease to intensive treatment (goal systolic blood pressure ≤ 120 mm Hg) or standard treatment (goal systolic blood pressure ≤ 140 mm Hg). In a prespecified subgroup of 2,636 participants over age 75 (mean age 80), hazard ratios and 95% confidence intervals for adverse outcomes with intensive treatment were:
- Major cardiovascular events: HR 0.66, 95% CI 0.51–0.85
- Death: HR 0.67, 95% CI 0.49–0.91.
Over 3 years of treatment this translated into a number needed to treat of 27 to prevent 1 cardiovascular event and 41 to prevent 1 death.
Within this subgroup, the benefit was similar regardless of level of frailty (measured both by a Rockwood frailty index and by gait speed).
However, the incidence of serious adverse treatment effects such as hypotension, orthostasis, electrolyte abnormalities, and acute kidney injury was higher with intensive treatment in the frail group. Although the difference was not statistically significant, it is cause for caution. Further, the exclusion criteria (history of diabetes, heart failure, dementia, stroke, weight loss of > 10%, nursing home residence) make it difficult to generalize the SPRINT findings to the general aging population.27
Tinetti et al28 performed an observational study using a nationally representative sample of older adults. They found that receiving any antihypertensive therapy was associated with an increased risk of falls with serious adverse outcomes. The risks of adverse events related to antihypertensive therapy increased with age.
Recommendations on hypertension
Managing hypertension in frail patients at risk of cardiovascular disease requires balancing the benefits vs the risks of treatment, such as polypharmacy, falls, and orthostatic hypotension.
The Eighth Joint National Committee suggests a blood pressure goal of less than 150/90 mm Hg for all adults over age 60, and less than 140/90 mm Hg for those with a history of cardiovascular disease or diabetes.29
The American College of Cardiology/American Heart Association (ACC/AHA) guidelines on hypertension, recently released, recommend a new blood pressure target of <120/<80 as normal, with 120–129/<80 considered elevated, 130–139/80–89 stage 1 hypertension, and ≥140/≥90 as stage 2 hypertension.30 An important caveat to these guidelines is the recommendation to measure blood pressure accurately and with accurate technique, which is often not possible in many busy clinics. These guidelines are intended to apply to older adults as well, with a note that those with multiple morbidities and limited life expectancy will benefit from a shared decision that incorporates patient preferences and clinical judgment. Little guidance is given on how to incorporate frailty, although note is made that older adults who reside in assisted living facilities and nursing homes have not been represented in randomized controlled trials.30
American Diabetes Association guidelines on hypertension in patients with diabetes recommend considering functional status, frailty, and life expectancy to decide on a blood pressure goal of either 140/90 mm Hg (if fit) or 150/90 mm Hg (if frail). They do not specify how to diagnose frailty.31
Canadian guidelines say that in those with advanced frailty (ie, entirely dependent for personal care and activities of daily living) and short life expectancy (months), it is reasonable to liberalize the systolic blood pressure goal to 160 to 190 mm Hg.32
Our recommendations. In both frail and nonfrail individuals without a limited life expectancy, it is reasonable to aim for a blood pressure of at least less than 140/90 mm Hg. For those at increased risk of cardiovascular disease and able to tolerate treatment, careful lowering to 130/80 mm Hg may be considered, with close attention to side effects.
Treatment should start with the lowest possible dose, be titrated slowly, and may need to be tailored to standing blood pressure to avoid orthostatic hypotension.
Home blood pressure measurements may be beneficial in monitoring treatment.
MANAGING LIPIDS
For those over age 75, data on efficacy of statins are mixed due to the small number of older adults enrolled in randomized controlled trials of these drugs. To our knowledge, no statin trial has examined the role of frailty.
The PROSPER trial (Prospective Study of Pravastatin in the Elderly at Risk)33 randomized 5,804 patients ages 70 to 82 to receive either pravastatin or placebo. Overall, the incidence of a composite end point of major cardiovascular events was 15% lower with active treatment (P = .014). However, the mean age was 75, which does little to address the paucity of evidence for those over age 75; follow-up time was only 3 years, and subgroup analysis did not show benefit in those who did not have a history of cardiovascular disease or in women.
The JUPITER trial (Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin)34 randomized 5,695 people over age 70 without cardiovascular disease to receive either rosuvastatin or placebo. Exploratory analysis showed a significant 39% reduction in all-cause mortality and major cardiovascular events with active treatment (HR 0.61, 95% CI 0.46–0.82). Over 5 years of treatment, this translates to a number needed to treat of 19 to prevent 1 major cardiovascular event and 29 to prevent 1 cardiovascular death.
The benefit of statins for primary prevention in these trials began to be apparent 2 years after treatment was initiated.
The Women’s Health Initiative,35 an observational study, found no difference in incident frailty in women older than 65 taking statins for 3 years compared with those who did not take statins
Odden et al36 found that although statin use is generally well tolerated, the risks of statin-associated functional and cognitive decline may outweigh the benefits in those older than 75. The ongoing Statin in Reducing Events in the Elderly (STAREE) trial may shed light on this issue.
Recommendations on lipid management
The ACC/AHA,3 in their 2013 guidelines, do not recommend routine statin treatment for primary prevention in those over age 75, given a lack of evidence from randomized controlled trials. For secondary prevention, ie, for those who have a history of atherosclerotic cardiovascular disease, they recommend moderate-intensity statin therapy in this age group.
Our recommendations. For patients over age 75 without cardiovascular disease or frailty and with a life expectancy of at least 2 years, consider offering a statin for primary prevention of cardiovascular disease as part of shared decision-making.
In those with known cardiovascular disease, it is reasonable to continue statin therapy except in situations where the life expectancy is less than 6 months.37
Although moderate- or high-intensity statin therapy is recommended in current guidelines, for many older adults it is prudent to consider the lowest tolerable dose to improve adherence, with close monitoring for side effects such as myalgia and weakness.
TYPE 2 DIABETES
Evidence suggests that tight glycemic control in type 2 diabetes is harmful for adults ages 55 to 79 and does not provide clear benefits for cardiovascular risk reduction, and controlling hemoglobin A1c to less than 6.0% is associated with increased mortality in older adults.38
The American Diabetes Association31 and the American Geriatrics Society39 recommend hemoglobin A1c goals of:
- 7.5% or less for older adults with 3 or more coexisting chronic illnesses requiring medical intervention (eg, arthritis, hypertension, and heart failure) and with intact cognition and function
- 8.0% or less for those identified as frail, or with multiple chronic illnesses or moderate cognitive or functional impairment
- 8.5% or 9.0% or less for those with very complex comorbidities, in long-term care, or with end-stage chronic illnesses (eg, end-stage heart failure), or with moderate to severe cognitive or functional limitation.
These guidelines do not endorse a specific frailty assessment, although the references allude to the Fried phenotype criteria, which include gait speed. An update from the American Diabetes Association provides a patient-centered approach to tailoring treatment regimens, taking into consideration the risk of hypoglycemia for each class of drugs, side effects, and cost.40
Our recommendations. Hyperglycemia remains a risk factor for cardiovascular disease in older adults and increases the risk of many geriatric conditions including delirium, dementia, frailty, and functional decline. The goal in individualizing hemoglobin A1c goals should be to avoid both hyper- and hypoglycemia.
Sulfonylureas and insulins should be used with caution, as they have the highest associated incidence of hypoglycemia of the diabetes medications.
ASPIRIN
For secondary prevention in older adults with a history of cardiovascular disease, pooled trials have consistently demonstrated a long-term benefit for aspirin use that exceeds bleeding risks, although age and frailty status were not considered.41
Aspirin for primary prevention?
The evidence for aspirin for primary prevention in older adults is mixed. Meta-analysis suggests a modest decrease in risk of nonfatal myocardial infarction but no appreciable effects on nonfatal stroke and cardiovascular death.42
The Japanese Primary Prevention Project,43 a randomized trial of low-dose aspirin for primary prevention of cardiovascular disease in adults ages 60 to 85, showed no reduction in major cardiovascular events. However, the event rate was lower than expected, the crossover rates were high, the incidence of hemorrhagic strokes was higher than in Western studies, and the trial may have been underpowered to detect the benefits of aspirin.
The US Preventive Services Task Force44 in 2016 noted that among individuals with a 10-year cardiovascular disease risk of 10% or higher based on the ACC/AHA pooled cohort equation,3 the greatest benefit of aspirin was in those ages 50 to 59. In this age group, 225 nonfatal myocardial infarctions and 84 nonfatal strokes were prevented per 10,000 men treated, with a net gain of 333 life-years. Similar findings were noted in women.
However, in those ages 60 to 69, the risks of harm begin to rise and the benefit of starting daily aspirin necessitates individualized clinical decision-making, with particular attention to bleeding risk and life expectancy.44
In those age 70 and older, data on benefit and harm are mixed. The bleeding risk of aspirin increases with age, predominantly due to gastrointestinal bleeding.44
The ongoing Aspirin in Reducing Events in Elderly trial will add to the evidence.
Aspirin recommendations for primary prevention
The American Geriatrics Society Beers Criteria do not routinely recommend aspirin use for primary prevention in those over age 80, even in those with diabetes.45
Our recommendations. In adults over age 75 who are not frail but are identified as being at moderate to high risk of cardiovascular disease using either the ACC/AHA calculator or any other risk estimator, and without a limited life expectancy, we believe it is reasonable to consider low-dose aspirin (75–100 mg daily) for primary prevention. However, there must be careful consideration particularly for those at risk of major bleeding. One approach to consider would be the addition of a proton pump inhibitor along with aspirin, though this requires further study.46
For those who have been on aspirin for primary prevention and are now older than age 80 without an adverse bleeding event, it is reasonable to stop aspirin, although risks and benefits of discontinuing aspirin should be discussed with the patient as part of shared decision-making.
In frail individuals the risks of aspirin therapy likely outweigh any benefit for primary prevention, and aspirin cannot be routinely recommended.
EXERCISE AND WEIGHT MANAGEMENT
A low body mass index is often associated with frailty, and weight loss may be a marker of underlying illness, which increases the risk of poor outcomes. However, those with an elevated body mass index and increased adiposity are in fact more likely to be frail (using the Fried physical phenotype definition) than those with a low body mass index,47 due in part to unrecognized sarcopenic obesity, ie, replacement of lean muscle with fat.
Physical activity is currently the only intervention known to improve frailty.5
Physical activity and a balanced diet are just as important in older adults, including those with reduced functional ability and multiple comorbid conditions, as in younger individuals.
A trial in frail long-term care residents (mean age 87) found that high-intensity resistance training improved muscle strength and mobility.48 The addition of a nutritional supplement with or without exercise did not affect frailty status. In community-dwelling older adults, physical activity has also been shown to improve sarcopenia and reduce falls and hip fractures.49
Progressive resistance training has been shown to improve strength and gait speed even in those with dementia.50
Tai chi has shown promising results in reducing falls and improving balance and function in both community-dwelling older adults and those in assisted living.51,52
Exercise recommendations
The US Department of Health and Human Services53 issued physical activity guidelines in 2008 with specific recommendations for older adults that include flexibility and balance training, which have been shown to reduce falls, in addition to aerobic activities and strength training.
Our recommendations. For all older adults, particularly those who are frail, we recommend a regimen of general daily activity, balance training such as tai chi, moderate-intensity aerobics such as cycling, resistance training such as using light weights, and stretching. Sessions lasting as little as 10 minutes are beneficial.
Gait speed can be monitored in the clinic to assess improvement in function over time.
SMOKING CESSATION
Although rates of smoking are decreasing, smoking remains one of the most important cardiovascular risk factors. Smoking has been associated with increased risk of frailty and significantly increased risk of death compared with never smoking.54 Smoking cessation is beneficial even for those who quit later in life.
The US Department of Health and Human Services in 2008 released an update on tobacco use and dependence,55 with specific attention to the benefit of smoking cessation for older adults.
All counseling interventions have been shown to be effective in older adults, as has nicotine replacement. Newer medications such as varenicline should be used with caution, as the risk of side effects is higher in older patients.
NUTRITION
Samieri et al,56 in an observational study of 10,670 nurses, found that those adhering to Mediterranean-style diets during midlife had 46% increased odds of healthy aging.
The PREDIMED study (Primary Prevention of Cardiovascular Disease With a Mediterranean Diet)57 in adults ages 55 to 80 showed the Mediterranean diet supplemented with olive oil and nuts reduced the incidence of major cardiovascular disease.
Leon-Munoz et al.58 A prospective study of 1,815 community-dwelling older adults followed for 3.5 years in Spain demonstrated that adhering to a Mediterranean diet was associated with a lower incidence of frailty (P = .002) and a lower risk of slow gait speed (OR 0.53, 95% CI 0.35–0.79). Interestingly, this study also found a protective association between fish and fruit consumption and frailty.
Our recommendations. A well-balanced, diverse diet rich in whole grains, fruits, vegetables, nuts, fish, and healthy fats (polyunsaturated fatty acids), with a moderate amount of lean meats, is recommended to prevent heart disease. However, poor dental health may limit the ability of older individuals to adhere to such diets, and modifications may be needed. Additionally, age-related changes in taste and smell may contribute to poor nutrition and unintended weight loss.59 Involving a nutritionist and social worker in the patient care team should be considered especially as poor nutrition may be a sign of cognitive impairment, functional decline, and frailty.
SPECIAL CONSIDERATIONS
Special considerations when managing cardiovascular risk in the older adult include polypharmacy, multimorbidity, quality of life, and the patient’s personal preferences.
Polypharmacy, defined as taking more than 5 medications, is associated with an increased risk of adverse drug events, falls, fractures, decreased adherence, and “prescribing cascade”— prescribing more drugs to treat side effects of the first drug (eg, adding hypertensive medications to treat hypertension induced by nonsteroidal anti-inflammatory drugs).60 This is particularly important when considering adding additional medications. If a statin will be the 20th pill, it may be less beneficial and more likely to lead to additional adverse effects than if it is the fifth medication.
Patient preferences are critically important, particularly when adding or removing medications. Interventions should include a detailed medication review for appropriate prescribing and deprescribing, referral to a pharmacist, and engaging the patient’s support system.
Multimorbidity. Many older individuals have multiple chronic illnesses. The interaction of multiple conditions must be considered in creating a comprehensive plan, including prognosis, patient preference, available evidence, treatment interactions, and risks and benefits.
Quality of life. Outlook on life and choices made regarding prolongation vs quality of life may be different for the older patient than the younger patient.
Personal preferences. Although interventions such as high-intensity statins for a robust 85-year-old may be appropriate, the individual can choose to forgo any treatment. It is important to explore the patient’s goals of care and advanced directives as part of shared decision-making when building a patient-centered prevention plan.61
ONE SIZE DOES NOT FIT ALL
The heterogeneity of aging rules out a one-size-fits-all recommendation for cardiovascular disease prevention and management of cardiovascular risk factors in older adults.
There is significant overlap between cardiovascular risk status and frailty.
Incorporating frailty into the creation of a cardiovascular risk prescription can aid in the development of an individualized care plan for the prevention of cardiovascular disease in the aging population.
- Social Security Administration (SSA). Calculators: life expectancy. www.ssa.gov/planners/lifeexpectancy.html. Accessed December 8, 2017.
- Benjamin EJ, Blaha MJ, Chiuve SE, et al. Heart disease and stroke statistics—2017 update: a report from the American Heart Association. Circulation 2017; 135:e146–e603.
- Stone NJ, Robinson JG, Lichtenstein AH, et al; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 2014; 63:2889–2934.
- Rich MW, Chyun DA, Skolnick AH, et al; American Heart Association Older Populations Committee of the Council on Clinical Cardiology, Council on Cardiovascular and Stroke Nursing, Council on Cardiovascular Surgery and Anesthesia, and Stroke Council; American College of Cardiology; and American Geriatrics Society. Knowledge gaps in cardiovascular care of the older adult population: a scientific statement from the American Heart Association, American College of Cardiology, and American Geriatrics Society. Circulation 2016; 133:2103–2122.
- Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet 2013; 381:752–762.
- Fried LP, Tangen CM, Walston J, et al; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci 2001; 56:M146–M156.
- Rockwood K, Mitnitski A. Frailty in relation to the accumulation of deficits. J Gerontol A Biol Sci Med Sci 2007; 62:722–727.
- Studenski S, Perera S, Patel K, et al. Gait speed and survival in older adults. JAMA 2011; 305:50–58.
- Afilalo J, Alexander KP, Mack MJ, et al. Frailty assessment in the cardiovascular care of older adults. J Am Coll Cardiol 2014; 63:747–762.
- Afilalo J, Karunananthan S, Eisenberg MJ, Alexander KP, Bergman H. Role of frailty in patients with cardiovascular disease. Am J Cardiol 2009; 103:1616–1621.
- Woods NF, LaCroix AZ, Gray SL, et al; Women’s Health Initiative. Frailty: emergence and consequences in women aged 65 and older in the Women's Health Initiative Observational Study. J Am Geriatr Soc 2005; 53:1321–1330.
- Bouillon K, Batty GD, Hamer M, et al. Cardiovascular disease risk scores in identifying future frailty: the Whitehall II prospective cohort study. Heart 2013; 99:737–742.
- Walston J, McBurnie MA, Newman A, et al; Cardiovascular Health Study. Frailty and activation of the inflammation and coagulation systems with and without clinical comorbidities: results from the Cardiovascular Health Study. Arch Intern Med 2002; 162:2333–2341.
- De Martinis M, Franceschi C, Monti D, Ginaldi L. Inflammation markers predicting frailty and mortality in the elderly. Exp Mol Pathol 2006; 80:219–227.
- Morley JE. Frailty fantasia. J Am Med Dir Assoc 2017; 18:813–815.
- Munoz-Mendoza CL, Cabanero-Martinez MJ, Millan-Calenti JC, Cabrero-Garcia J, Lopez-Sanchez R, Maseda-Rodriguez A. Reliability of 4-m and 6-m walking speed tests in elderly people with cognitive impairment. Arch Gerontol Geriatr 2011; 52:e67–e70.
- Abellan van Kan G, Rolland Y, Andrieu S, et al. Gait speed at usual pace as a predictor of adverse outcomes in community-dwelling older people an International Academy on Nutrition and Aging (IANA) Task Force. J Nutr Health Aging 2009; 13:881–889.
- Sergi G, Veronese N, Fontana L, et al. Pre-frailty and risk of cardiovascular disease in elderly men and women: the Pro.V.A. study. J Am Coll Cardiol 2015; 65:976–983.
- Abellan van Kan G, Rolland Y, Bergman H, Morley JE, Kritchevsky SB, Vellas B. The I.A.N.A Task Force on frailty assessment of older people in clinical practice. J Nutr Health Aging 2008; 12:29–37.
- Morley JE, Malmstrom TK, Miller DK. A simple frailty questionnaire (FRAIL) predicts outcomes in middle-aged African Americans. J Nutr Health Aging 2012;16:601–608.
- Forman DE, Arena R, Boxer R, et al; American Heart Association Council on Clinical Cardiology; Council on Cardiovascular and Stroke Nursing; Council on Quality of Care and Outcomes Research; and Stroke Council. Prioritizing functional capacity as a principal end point for therapies oriented to older adults with cardiovascular disease: a scientific statement for healthcare professionals from the American Heart Association. Circulation 2017; 135:e894–e918.
- Lewington S, Clarke R, Qizilbash N, Peto R, Collins R; Prospective Studies Collaboration. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet 2002; 360:1903–1913.
- Mancia G, Grassi G. Aggressive blood pressure lowering is dangerous: the J-curve: pro side of the argument. Hypertension 2014; 63:29–36.
- Odden MC, Peralta CA, Haan MN, Covinsky KE. Rethinking the association of high blood pressure with mortality in elderly adults: the impact of frailty. Arch Intern Med 2012; 172:1162–1168.
- Beckett NS, Peters R, Fletcher AE, et al; HYVET Study Group. Treatment of hypertension in patients 80 years of age or older. N Engl J Med 2008; 358:1887–1898.
- Warwick J, Falaschetti E, Rockwood K, et al. No evidence that frailty modifies the positive impact of antihypertensive treatment in very elderly people: an investigation of the impact of frailty upon treatment effect in the HYpertension in the Very Elderly Trial (HYVET) study, a double-blind, placebo-controlled study of antihypertensives in people with hypertension aged 80 and over. BMC Med 2015 9;13:78.
- Williamson JD, Supiano MA, Applegate WB, et al; SPRINT Research Group. Intensive vs standard blood pressure control and cardiovascular disease outcomes in adults aged ≥ 75 years: a randomized clinical trial. JAMA 2016; 315:2673–2682.
- Tinetti ME, Han L, Lee DS, et al. Antihypertensive medications and serious fall injuries in a nationally representative sample of older adults. JAMA Intern Med 2014; 174:588–595.
- James PA, Oparil S, Carter BL, et al. 2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA 2014; 311:507–520.
- Whelton PK, Carey RM, Aronow WS, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension 2017. Nov 13 [Epub ahead of print].)
- American Diabetes Association. 11. Older adults. Diabetes Care 2017; 40(suppl 1):S99–S104.
- Mallery LH, Allen M, Fleming I, et al. Promoting higher blood pressure targets for frail older adults: a consensus guideline from Canada. Cleve Clin J Med 2014; 81:427–437.
- Shepherd J, Blauw GJ, Murphy MB, et al; PROSPER study group. PROspective Study of Pravastatin in the Elderly at Risk. Pravastatin in elderly individuals at risk of vascular disease (PROSPER): a randomised controlled trial. Lancet 2002; 360:1623–1630.
- Glynn RJ, Koenig W, Nordestgaard BG, Shepherd J, Ridker PM. Rosuvastatin for primary prevention in older persons with elevated C-reactive protein and low to average low-density lipoprotein cholesterol levels: exploratory analysis of a randomized trial. Ann Intern Med 2010; 152:488–496, W174.
- LaCroix AZ, Gray SL, Aragaki A, et al; Women’s Health Initiative. Statin use and incident frailty in women aged 65 years or older: prospective findings from the Women’s Health Initiative Observational Study. J Gerontol A Biol Sci Med Sci 2008; 63:369–375.
- Odden MC, Pletcher MJ, Coxson PG, et al. Cost-effectiveness and population impact of statins for primary prevention in adults aged 75 years or older in the United States. Ann Intern Med 2015; 162:533–541.
- Kutner JS, Blatchford PJ, Taylor DH Jr, et al. Safety and benefit of discontinuing statin therapy in the setting of advanced, life-limiting illness: a randomized clinical trial. JAMA Intern Med 2015; 175:691–700.
- Huang ES, Liu JY, Moffet HH, John PM, Karter AJ. Glycemic control, complications, and death in older diabetic patients: the diabetes and aging study. Diabetes Care 2011; 34:1329–1336.
- Kirkman MS, Briscoe VJ, Clark N, et al; Consensus Development Conference on Diabetes and Older Adults. Diabetes in older adults: a consensus report. J Am Geriatr Soc 2012; 60:2342–2356.
- Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes, 2015: a patient-centered approach: update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2015; 38:140–149.
- Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. BMJ (Clinical research ed) 2002; 324:71–86.
- Antithrombotic Trialists’ (ATT) Collaboration; Baigent C, Blackwell L, Collins R, et al. Aspirin in the primary and secondary prevention of vascular disease: collaborative meta-analysis of individual participant data from randomised trials. Lancet 2009; 373:1849–1860.
- Ikeda Y, Shimada K, Teramoto T, et al. Low-dose aspirin for primary prevention of cardiovascular events in Japanese patients 60 years or older with atherosclerotic risk factors: a randomized clinical trial. JAMA 2014; 312:2510–2520.
- Bibbins-Domingo K; US Preventive Services Task Force. Aspirin use for the primary prevention of cardiovascular disease and colorectal cancer: US Preventive Services Task Force Recommendation Statement. Ann Intern Med 2016; 164:836–845.
- American Geriatrics Society 2012 Beers Criteria Update Expert Panel. American Geriatrics Society updated Beers Criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc 2012; 60:616–631.
- Li L, Geraghty OC, Mehta Z, Rothwell PM. Age-specific risks, severity, time course, and outcome of bleeding on long-term antiplatelet treatment after vascular events: a population-based cohort study. Lancet 2017; 390:490–499.
- Barzilay JI, Blaum C, Moore T, et al. Insulin resistance and inflammation as precursors of frailty: the Cardiovascular Health Study. Arch Intern Med 2007; 167:635–641.
- Fiatarone MA, O’Neill EF, Ryan ND, et al. Exercise training and nutritional supplementation for physical frailty in very elderly people. N Engl J Med 1994; 330:1769–1775.
- Uusi-Rasi K, Patil R, Karinkanta S, et al. Exercise and vitamin D in fall prevention among older women: a randomized clinical trial. JAMA Intern Med 2015; 175:703–711.
- Hauer K, Schwenk M, Zieschang T, Essig M, Becker C, Oster P. Physical training improves motor performance in people with dementia: a randomized controlled trial. J Am Geriatr Soc 2012; 60:8–15.
- Li F, Harmer P, Fitzgerald K. Implementing an evidence-based fall prevention intervention in community senior centers. Am J Public Health 2016; 106:2026–2031.
- Manor B, Lough M, Gagnon MM, Cupples A, Wayne PM, Lipsitz LA. Functional benefits of tai chi training in senior housing facilities. J Am Geriatr Soc 2014; 62:1484–1489.
- Physical Activity Guidelines Advisory Committee report, 2008. To the Secretary of Health and Human Services. Part A: executive summary. Nutr Rev 2009; 67:114–120.
- Hubbard RE, Searle SD, Mitnitski A, Rockwood K. Effect of smoking on the accumulation of deficits, frailty and survival in older adults: a secondary analysis from the Canadian Study of Health and Aging. J Nutr Health Aging 2009; 13:468–472.
- Clinical Practice Guideline Treating Tobacco Use and Dependence 2008 Update Panel, Liaisons, and Staff. A clinical practice guideline for treating tobacco use and dependence: 2008 update. A US Public Health Service report. Am J Prev Med 2008; 35:158–176.
- Samieri C, Sun Q, Townsend MK, et al. The association between dietary patterns at midlife and health in aging: an observational study. Ann Intern Med 2013; 159:584–591.
- Estruch R, Ros E, Martinez-Gonzalez MA. Mediterranean diet for primary prevention of cardiovascular disease. N Engl J Med 2013; 369:676–677.
- Leon-Munoz LM, Guallar-Castillon P, Lopez-Garcia E, Rodriguez-Artalejo F. Mediterranean diet and risk of frailty in community-dwelling older adults. J Am Med Dir Assoc 2014; 15:899–903.
- Doty RL, Shaman P, Applebaum SL, Giberson R, Siksorski L, Rosenberg L. Smell identification ability: changes with age. Science 1984; 226:1441–1443.
- Merel SE, Paauw DS. Common drug side effects and drug-drug interactions in elderly adults in primary care. J Am Geriatr Soc 2017 Mar 21. Epub ahead of print.
- Epstein RM, Peters E. Beyond information: exploring patients’ preferences. JAMA 2009; 302:195–197.
When assessing and attempting to modify the risk of cardiovascular disease in older patients, physicians should consider incorporating the concept of frailty. The balance of risk and benefit may differ considerably for 2 patients of the same age if one is fit and the other is frail. Because the aging population is a diverse group, a one-size-fits-all approach to cardiovascular disease prevention and risk-factor management is not appropriate.
A GROWING, DIVERSE GROUP
The number of older adults with multiple cardiovascular risk factors is increasing as life expectancy improves. US residents who are age 65 today can expect to live to an average age of 84 (men) or 87 (women).1
However, the range of life expectancy for people reaching these advanced ages is wide, and chronologic age is no longer sufficient to determine a patient’s risk profile. Furthermore, the prevalence of cardiovascular disease rises with age, and age itself is the strongest predictor of cardiovascular risk.2
Current risk calculators have not been validated in people over age 80,2 making them inadequate for use in older patients. Age alone cannot identify who will benefit from preventive strategies, except in situations when a dominant disease such as metastatic cancer, end-stage renal disease, end-stage dementia, or end-stage heart failure is expected to lead to mortality within a year. Guidelines for treating common risk factors such as elevated cholesterol3 in the general population have generally not focused on adults over 75 or recognized their diversity in health status.4 In order to generate an individualized prescription for cardiovascular disease prevention for older adults, issues such as frailty, cognitive and functional status, disability, and comorbidity must be considered.
WHAT IS FRAILTY?
Clinicians have recognized frailty for decades, but to date there remains a debate on how to define it.
Clegg et al5 described frailty as “a state of increased vulnerability to poor resolution of homeostasis after a stressor event,”5 a definition generally agreed upon, as frailty predicts both poor health outcomes and death.
Indeed, in a prospective study of 5,317 men and women ranging in age from 65 to 101, those identified as frail at baseline were 6 times more likely to have died 3 years later (mortality rates 18% vs 3%), and the difference persisted at 7 years.6 After adjusting for comorbidities, those identified as frail were also more likely to fall, develop limitations in mobility or activities of daily living, or be hospitalized.
The two current leading theories of frailty were defined by Fried et al6 and by Rockwood and Mitnitski.7
Fried et al6 have operationalized frailty as a “physical phenotype,” defined as 3 or more of the following:
- Unintentional weight loss of 10 pounds in the past year
- Self-reported exhaustion
- Weakness as measured by grip strength
- Slow walking speed
- Decreased physical activity.6
Rockwood and Mitnitski7 define frailty as an accumulation of health-related deficits over time. They recommend that 30 to 40 possible deficits that cover a variety of health systems be included such as cognition, mood, function, and comorbidity. These are added and divided by the total possible number of variables to generate a score between 0 and 1.8
The difficulty in defining frailty has led to varying estimates of its prevalence, ranging from 25% to 50% in adults over 65 who have cardiovascular disease.9
CAUSE AND CONSEQUENCE OF CARDIOVASCULAR DISEASE
Studies have highlighted the bidirectional connection between frailty and cardiovascular disease.10 Frailty may predict cardiovascular disease, while cardiovascular disease is associated with an increased risk of incident frailty.9,11
Frail adults with cardiovascular disease have a higher risk of poor outcomes, even after correcting for age, comorbidities, disability, and disease severity. For example, frailty is associated with a twofold higher mortality rate in individuals with cardiovascular disease.9
A prospective cohort study12 of 3,895 middle-aged men and women demonstrated that those with an elevated cardiovascular risk score were at increased risk of frailty over 10 years (odds ratio [OR] 1.35, 95% confidence interval [CI] 1.21–1.51) and incident cardiovascular events (OR 1.36, 95% CI 1.15–1.61). This suggests that modification of cardiovascular risk factors earlier in life may reduce the risk of subsequently becoming frail.
Biologic mechanisms that may explain the connection between frailty and cardiovascular disease include derangements in inflammatory, hematologic, and endocrine pathways. People who are found to be clinically frail are more likely to have insulin resistance and elevated biomarkers such as C-reactive protein, D-dimer, and factor VIII.13 The inflammatory cytokine interleukin 6 is suggested as a common link between inflammation and thrombosis, perhaps contributing to the connection between cardiovascular disease and frailty. Many of these biomarkers have been linked to the pathophysiologic changes of aging, so-called “inflamm-aging” or immunosenescence, including sarcopenia, osteoporosis, and cardiovascular disease.14
ASSESSING FRAILTY IN THE CLINIC
For adults over age 70, frailty assessment is an important first step in managing cardiovascular disease risk.15 Frailty status will better identify those at risk of adverse outcomes in the short term and those who are most likely to benefit from long-term cardiovascular preventive strategies. Additionally, incorporating frailty assessment into traditional risk factor evaluation may permit appropriate intervention and prevention of a potentially modifiable risk factor.
Gait speed is a quick, easy, inexpensive, and sensitive way to assess frailty status, with excellent inter-rater and test-retest reliability, even in those with cognitive impairment.16 Slow gait speed predicts limitations in mobility, limitations in activities of daily living, and death.8,17
In a prospective study18 of 1,567 men and women, mean age 74, slow gait speed was the strongest predictor of subsequent cardiovascular events.18
Gait speed is usually measured over a distance of 4 meters (13.1 feet),17 and the patient is asked to walk comfortably in an unobstructed, marked area. An assistive walking device can be used if needed. If possible, this is repeated once after a brief recovery period, and the average is recorded.
The FRAIL scale19,20 is a simple, validated questionnaire that combines the Fried and Rockwood concepts of frailty and can be given over the phone or to patients in a waiting room. One point is given for each of the following, and people who have 3 or more are considered frail:
- Fatigue
- Resistance (inability to climb 1 flight of stairs)
- Ambulation (inability to walk 1 block)
- Illnesses (having more than 5)
- Loss of more than 5% of body weight.
Other measures of physical function such as grip strength (using a dynamometer), the Timed Up and Go test (assessing the ability to get up from a chair and walk a short distance), and Short Physical Performance Battery (assessing balance, chair stands, and walking speed) can be used to screen for frailty, but are more time-intensive than gait speed alone, and so are not always practical to use in a busy clinic.21
MANAGEMENT OF RISK FACTORS
Management of cardiovascular risk factors is best individualized as outlined below.
LOWERING HIGH BLOOD PRESSURE
The incidence of ischemic heart disease and stroke increases with age across all levels of elevated systolic and diastolic blood pressure.22 Hypertension is also associated with increased risk of cognitive decline. However, a J-shaped relationship has been observed in older adults, with increased cardiovascular events for both low and elevated blood pressure, although the clinical relevance remains controversial.23
Odden et al24 performed an observational study and found that high blood pressure was associated with an increased mortality rate in older adults with normal gait speed, while in those with slow gait speed, high blood pressure neither harmed nor helped. Those who could not walk 6 meters appeared to benefit from higher blood pressure.
HYVET (the Hypertension in the Very Elderly Trial),25 a randomized controlled trial in 3,845 community-dwelling people age 80 or older with sustained systolic blood pressure higher than 160 mm Hg, found a significant reduction in rates of stroke and all-cause mortality (relative risk [RR] 0.76, P = .007) in the treatment arm using indapamide with perindopril if necessary to reach a target blood pressure of 150/80 mm Hg.
Frailty was not assessed during the trial; however, in a reanalysis, the results did not change in those identified as frail using a Rockwood frailty index (a count of health-related deficits accumulated over the lifespan).26
SPRINT (the Systolic Blood Pressure Intervention Trial)27 randomized participants age 50 and older with systolic blood pressure of 130 to 180 mm Hg and at increased risk of cardiovascular disease to intensive treatment (goal systolic blood pressure ≤ 120 mm Hg) or standard treatment (goal systolic blood pressure ≤ 140 mm Hg). In a prespecified subgroup of 2,636 participants over age 75 (mean age 80), hazard ratios and 95% confidence intervals for adverse outcomes with intensive treatment were:
- Major cardiovascular events: HR 0.66, 95% CI 0.51–0.85
- Death: HR 0.67, 95% CI 0.49–0.91.
Over 3 years of treatment this translated into a number needed to treat of 27 to prevent 1 cardiovascular event and 41 to prevent 1 death.
Within this subgroup, the benefit was similar regardless of level of frailty (measured both by a Rockwood frailty index and by gait speed).
However, the incidence of serious adverse treatment effects such as hypotension, orthostasis, electrolyte abnormalities, and acute kidney injury was higher with intensive treatment in the frail group. Although the difference was not statistically significant, it is cause for caution. Further, the exclusion criteria (history of diabetes, heart failure, dementia, stroke, weight loss of > 10%, nursing home residence) make it difficult to generalize the SPRINT findings to the general aging population.27
Tinetti et al28 performed an observational study using a nationally representative sample of older adults. They found that receiving any antihypertensive therapy was associated with an increased risk of falls with serious adverse outcomes. The risks of adverse events related to antihypertensive therapy increased with age.
Recommendations on hypertension
Managing hypertension in frail patients at risk of cardiovascular disease requires balancing the benefits vs the risks of treatment, such as polypharmacy, falls, and orthostatic hypotension.
The Eighth Joint National Committee suggests a blood pressure goal of less than 150/90 mm Hg for all adults over age 60, and less than 140/90 mm Hg for those with a history of cardiovascular disease or diabetes.29
The American College of Cardiology/American Heart Association (ACC/AHA) guidelines on hypertension, recently released, recommend a new blood pressure target of <120/<80 as normal, with 120–129/<80 considered elevated, 130–139/80–89 stage 1 hypertension, and ≥140/≥90 as stage 2 hypertension.30 An important caveat to these guidelines is the recommendation to measure blood pressure accurately and with accurate technique, which is often not possible in many busy clinics. These guidelines are intended to apply to older adults as well, with a note that those with multiple morbidities and limited life expectancy will benefit from a shared decision that incorporates patient preferences and clinical judgment. Little guidance is given on how to incorporate frailty, although note is made that older adults who reside in assisted living facilities and nursing homes have not been represented in randomized controlled trials.30
American Diabetes Association guidelines on hypertension in patients with diabetes recommend considering functional status, frailty, and life expectancy to decide on a blood pressure goal of either 140/90 mm Hg (if fit) or 150/90 mm Hg (if frail). They do not specify how to diagnose frailty.31
Canadian guidelines say that in those with advanced frailty (ie, entirely dependent for personal care and activities of daily living) and short life expectancy (months), it is reasonable to liberalize the systolic blood pressure goal to 160 to 190 mm Hg.32
Our recommendations. In both frail and nonfrail individuals without a limited life expectancy, it is reasonable to aim for a blood pressure of at least less than 140/90 mm Hg. For those at increased risk of cardiovascular disease and able to tolerate treatment, careful lowering to 130/80 mm Hg may be considered, with close attention to side effects.
Treatment should start with the lowest possible dose, be titrated slowly, and may need to be tailored to standing blood pressure to avoid orthostatic hypotension.
Home blood pressure measurements may be beneficial in monitoring treatment.
MANAGING LIPIDS
For those over age 75, data on efficacy of statins are mixed due to the small number of older adults enrolled in randomized controlled trials of these drugs. To our knowledge, no statin trial has examined the role of frailty.
The PROSPER trial (Prospective Study of Pravastatin in the Elderly at Risk)33 randomized 5,804 patients ages 70 to 82 to receive either pravastatin or placebo. Overall, the incidence of a composite end point of major cardiovascular events was 15% lower with active treatment (P = .014). However, the mean age was 75, which does little to address the paucity of evidence for those over age 75; follow-up time was only 3 years, and subgroup analysis did not show benefit in those who did not have a history of cardiovascular disease or in women.
The JUPITER trial (Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin)34 randomized 5,695 people over age 70 without cardiovascular disease to receive either rosuvastatin or placebo. Exploratory analysis showed a significant 39% reduction in all-cause mortality and major cardiovascular events with active treatment (HR 0.61, 95% CI 0.46–0.82). Over 5 years of treatment, this translates to a number needed to treat of 19 to prevent 1 major cardiovascular event and 29 to prevent 1 cardiovascular death.
The benefit of statins for primary prevention in these trials began to be apparent 2 years after treatment was initiated.
The Women’s Health Initiative,35 an observational study, found no difference in incident frailty in women older than 65 taking statins for 3 years compared with those who did not take statins
Odden et al36 found that although statin use is generally well tolerated, the risks of statin-associated functional and cognitive decline may outweigh the benefits in those older than 75. The ongoing Statin in Reducing Events in the Elderly (STAREE) trial may shed light on this issue.
Recommendations on lipid management
The ACC/AHA,3 in their 2013 guidelines, do not recommend routine statin treatment for primary prevention in those over age 75, given a lack of evidence from randomized controlled trials. For secondary prevention, ie, for those who have a history of atherosclerotic cardiovascular disease, they recommend moderate-intensity statin therapy in this age group.
Our recommendations. For patients over age 75 without cardiovascular disease or frailty and with a life expectancy of at least 2 years, consider offering a statin for primary prevention of cardiovascular disease as part of shared decision-making.
In those with known cardiovascular disease, it is reasonable to continue statin therapy except in situations where the life expectancy is less than 6 months.37
Although moderate- or high-intensity statin therapy is recommended in current guidelines, for many older adults it is prudent to consider the lowest tolerable dose to improve adherence, with close monitoring for side effects such as myalgia and weakness.
TYPE 2 DIABETES
Evidence suggests that tight glycemic control in type 2 diabetes is harmful for adults ages 55 to 79 and does not provide clear benefits for cardiovascular risk reduction, and controlling hemoglobin A1c to less than 6.0% is associated with increased mortality in older adults.38
The American Diabetes Association31 and the American Geriatrics Society39 recommend hemoglobin A1c goals of:
- 7.5% or less for older adults with 3 or more coexisting chronic illnesses requiring medical intervention (eg, arthritis, hypertension, and heart failure) and with intact cognition and function
- 8.0% or less for those identified as frail, or with multiple chronic illnesses or moderate cognitive or functional impairment
- 8.5% or 9.0% or less for those with very complex comorbidities, in long-term care, or with end-stage chronic illnesses (eg, end-stage heart failure), or with moderate to severe cognitive or functional limitation.
These guidelines do not endorse a specific frailty assessment, although the references allude to the Fried phenotype criteria, which include gait speed. An update from the American Diabetes Association provides a patient-centered approach to tailoring treatment regimens, taking into consideration the risk of hypoglycemia for each class of drugs, side effects, and cost.40
Our recommendations. Hyperglycemia remains a risk factor for cardiovascular disease in older adults and increases the risk of many geriatric conditions including delirium, dementia, frailty, and functional decline. The goal in individualizing hemoglobin A1c goals should be to avoid both hyper- and hypoglycemia.
Sulfonylureas and insulins should be used with caution, as they have the highest associated incidence of hypoglycemia of the diabetes medications.
ASPIRIN
For secondary prevention in older adults with a history of cardiovascular disease, pooled trials have consistently demonstrated a long-term benefit for aspirin use that exceeds bleeding risks, although age and frailty status were not considered.41
Aspirin for primary prevention?
The evidence for aspirin for primary prevention in older adults is mixed. Meta-analysis suggests a modest decrease in risk of nonfatal myocardial infarction but no appreciable effects on nonfatal stroke and cardiovascular death.42
The Japanese Primary Prevention Project,43 a randomized trial of low-dose aspirin for primary prevention of cardiovascular disease in adults ages 60 to 85, showed no reduction in major cardiovascular events. However, the event rate was lower than expected, the crossover rates were high, the incidence of hemorrhagic strokes was higher than in Western studies, and the trial may have been underpowered to detect the benefits of aspirin.
The US Preventive Services Task Force44 in 2016 noted that among individuals with a 10-year cardiovascular disease risk of 10% or higher based on the ACC/AHA pooled cohort equation,3 the greatest benefit of aspirin was in those ages 50 to 59. In this age group, 225 nonfatal myocardial infarctions and 84 nonfatal strokes were prevented per 10,000 men treated, with a net gain of 333 life-years. Similar findings were noted in women.
However, in those ages 60 to 69, the risks of harm begin to rise and the benefit of starting daily aspirin necessitates individualized clinical decision-making, with particular attention to bleeding risk and life expectancy.44
In those age 70 and older, data on benefit and harm are mixed. The bleeding risk of aspirin increases with age, predominantly due to gastrointestinal bleeding.44
The ongoing Aspirin in Reducing Events in Elderly trial will add to the evidence.
Aspirin recommendations for primary prevention
The American Geriatrics Society Beers Criteria do not routinely recommend aspirin use for primary prevention in those over age 80, even in those with diabetes.45
Our recommendations. In adults over age 75 who are not frail but are identified as being at moderate to high risk of cardiovascular disease using either the ACC/AHA calculator or any other risk estimator, and without a limited life expectancy, we believe it is reasonable to consider low-dose aspirin (75–100 mg daily) for primary prevention. However, there must be careful consideration particularly for those at risk of major bleeding. One approach to consider would be the addition of a proton pump inhibitor along with aspirin, though this requires further study.46
For those who have been on aspirin for primary prevention and are now older than age 80 without an adverse bleeding event, it is reasonable to stop aspirin, although risks and benefits of discontinuing aspirin should be discussed with the patient as part of shared decision-making.
In frail individuals the risks of aspirin therapy likely outweigh any benefit for primary prevention, and aspirin cannot be routinely recommended.
EXERCISE AND WEIGHT MANAGEMENT
A low body mass index is often associated with frailty, and weight loss may be a marker of underlying illness, which increases the risk of poor outcomes. However, those with an elevated body mass index and increased adiposity are in fact more likely to be frail (using the Fried physical phenotype definition) than those with a low body mass index,47 due in part to unrecognized sarcopenic obesity, ie, replacement of lean muscle with fat.
Physical activity is currently the only intervention known to improve frailty.5
Physical activity and a balanced diet are just as important in older adults, including those with reduced functional ability and multiple comorbid conditions, as in younger individuals.
A trial in frail long-term care residents (mean age 87) found that high-intensity resistance training improved muscle strength and mobility.48 The addition of a nutritional supplement with or without exercise did not affect frailty status. In community-dwelling older adults, physical activity has also been shown to improve sarcopenia and reduce falls and hip fractures.49
Progressive resistance training has been shown to improve strength and gait speed even in those with dementia.50
Tai chi has shown promising results in reducing falls and improving balance and function in both community-dwelling older adults and those in assisted living.51,52
Exercise recommendations
The US Department of Health and Human Services53 issued physical activity guidelines in 2008 with specific recommendations for older adults that include flexibility and balance training, which have been shown to reduce falls, in addition to aerobic activities and strength training.
Our recommendations. For all older adults, particularly those who are frail, we recommend a regimen of general daily activity, balance training such as tai chi, moderate-intensity aerobics such as cycling, resistance training such as using light weights, and stretching. Sessions lasting as little as 10 minutes are beneficial.
Gait speed can be monitored in the clinic to assess improvement in function over time.
SMOKING CESSATION
Although rates of smoking are decreasing, smoking remains one of the most important cardiovascular risk factors. Smoking has been associated with increased risk of frailty and significantly increased risk of death compared with never smoking.54 Smoking cessation is beneficial even for those who quit later in life.
The US Department of Health and Human Services in 2008 released an update on tobacco use and dependence,55 with specific attention to the benefit of smoking cessation for older adults.
All counseling interventions have been shown to be effective in older adults, as has nicotine replacement. Newer medications such as varenicline should be used with caution, as the risk of side effects is higher in older patients.
NUTRITION
Samieri et al,56 in an observational study of 10,670 nurses, found that those adhering to Mediterranean-style diets during midlife had 46% increased odds of healthy aging.
The PREDIMED study (Primary Prevention of Cardiovascular Disease With a Mediterranean Diet)57 in adults ages 55 to 80 showed the Mediterranean diet supplemented with olive oil and nuts reduced the incidence of major cardiovascular disease.
Leon-Munoz et al.58 A prospective study of 1,815 community-dwelling older adults followed for 3.5 years in Spain demonstrated that adhering to a Mediterranean diet was associated with a lower incidence of frailty (P = .002) and a lower risk of slow gait speed (OR 0.53, 95% CI 0.35–0.79). Interestingly, this study also found a protective association between fish and fruit consumption and frailty.
Our recommendations. A well-balanced, diverse diet rich in whole grains, fruits, vegetables, nuts, fish, and healthy fats (polyunsaturated fatty acids), with a moderate amount of lean meats, is recommended to prevent heart disease. However, poor dental health may limit the ability of older individuals to adhere to such diets, and modifications may be needed. Additionally, age-related changes in taste and smell may contribute to poor nutrition and unintended weight loss.59 Involving a nutritionist and social worker in the patient care team should be considered especially as poor nutrition may be a sign of cognitive impairment, functional decline, and frailty.
SPECIAL CONSIDERATIONS
Special considerations when managing cardiovascular risk in the older adult include polypharmacy, multimorbidity, quality of life, and the patient’s personal preferences.
Polypharmacy, defined as taking more than 5 medications, is associated with an increased risk of adverse drug events, falls, fractures, decreased adherence, and “prescribing cascade”— prescribing more drugs to treat side effects of the first drug (eg, adding hypertensive medications to treat hypertension induced by nonsteroidal anti-inflammatory drugs).60 This is particularly important when considering adding additional medications. If a statin will be the 20th pill, it may be less beneficial and more likely to lead to additional adverse effects than if it is the fifth medication.
Patient preferences are critically important, particularly when adding or removing medications. Interventions should include a detailed medication review for appropriate prescribing and deprescribing, referral to a pharmacist, and engaging the patient’s support system.
Multimorbidity. Many older individuals have multiple chronic illnesses. The interaction of multiple conditions must be considered in creating a comprehensive plan, including prognosis, patient preference, available evidence, treatment interactions, and risks and benefits.
Quality of life. Outlook on life and choices made regarding prolongation vs quality of life may be different for the older patient than the younger patient.
Personal preferences. Although interventions such as high-intensity statins for a robust 85-year-old may be appropriate, the individual can choose to forgo any treatment. It is important to explore the patient’s goals of care and advanced directives as part of shared decision-making when building a patient-centered prevention plan.61
ONE SIZE DOES NOT FIT ALL
The heterogeneity of aging rules out a one-size-fits-all recommendation for cardiovascular disease prevention and management of cardiovascular risk factors in older adults.
There is significant overlap between cardiovascular risk status and frailty.
Incorporating frailty into the creation of a cardiovascular risk prescription can aid in the development of an individualized care plan for the prevention of cardiovascular disease in the aging population.
When assessing and attempting to modify the risk of cardiovascular disease in older patients, physicians should consider incorporating the concept of frailty. The balance of risk and benefit may differ considerably for 2 patients of the same age if one is fit and the other is frail. Because the aging population is a diverse group, a one-size-fits-all approach to cardiovascular disease prevention and risk-factor management is not appropriate.
A GROWING, DIVERSE GROUP
The number of older adults with multiple cardiovascular risk factors is increasing as life expectancy improves. US residents who are age 65 today can expect to live to an average age of 84 (men) or 87 (women).1
However, the range of life expectancy for people reaching these advanced ages is wide, and chronologic age is no longer sufficient to determine a patient’s risk profile. Furthermore, the prevalence of cardiovascular disease rises with age, and age itself is the strongest predictor of cardiovascular risk.2
Current risk calculators have not been validated in people over age 80,2 making them inadequate for use in older patients. Age alone cannot identify who will benefit from preventive strategies, except in situations when a dominant disease such as metastatic cancer, end-stage renal disease, end-stage dementia, or end-stage heart failure is expected to lead to mortality within a year. Guidelines for treating common risk factors such as elevated cholesterol3 in the general population have generally not focused on adults over 75 or recognized their diversity in health status.4 In order to generate an individualized prescription for cardiovascular disease prevention for older adults, issues such as frailty, cognitive and functional status, disability, and comorbidity must be considered.
WHAT IS FRAILTY?
Clinicians have recognized frailty for decades, but to date there remains a debate on how to define it.
Clegg et al5 described frailty as “a state of increased vulnerability to poor resolution of homeostasis after a stressor event,”5 a definition generally agreed upon, as frailty predicts both poor health outcomes and death.
Indeed, in a prospective study of 5,317 men and women ranging in age from 65 to 101, those identified as frail at baseline were 6 times more likely to have died 3 years later (mortality rates 18% vs 3%), and the difference persisted at 7 years.6 After adjusting for comorbidities, those identified as frail were also more likely to fall, develop limitations in mobility or activities of daily living, or be hospitalized.
The two current leading theories of frailty were defined by Fried et al6 and by Rockwood and Mitnitski.7
Fried et al6 have operationalized frailty as a “physical phenotype,” defined as 3 or more of the following:
- Unintentional weight loss of 10 pounds in the past year
- Self-reported exhaustion
- Weakness as measured by grip strength
- Slow walking speed
- Decreased physical activity.6
Rockwood and Mitnitski7 define frailty as an accumulation of health-related deficits over time. They recommend that 30 to 40 possible deficits that cover a variety of health systems be included such as cognition, mood, function, and comorbidity. These are added and divided by the total possible number of variables to generate a score between 0 and 1.8
The difficulty in defining frailty has led to varying estimates of its prevalence, ranging from 25% to 50% in adults over 65 who have cardiovascular disease.9
CAUSE AND CONSEQUENCE OF CARDIOVASCULAR DISEASE
Studies have highlighted the bidirectional connection between frailty and cardiovascular disease.10 Frailty may predict cardiovascular disease, while cardiovascular disease is associated with an increased risk of incident frailty.9,11
Frail adults with cardiovascular disease have a higher risk of poor outcomes, even after correcting for age, comorbidities, disability, and disease severity. For example, frailty is associated with a twofold higher mortality rate in individuals with cardiovascular disease.9
A prospective cohort study12 of 3,895 middle-aged men and women demonstrated that those with an elevated cardiovascular risk score were at increased risk of frailty over 10 years (odds ratio [OR] 1.35, 95% confidence interval [CI] 1.21–1.51) and incident cardiovascular events (OR 1.36, 95% CI 1.15–1.61). This suggests that modification of cardiovascular risk factors earlier in life may reduce the risk of subsequently becoming frail.
Biologic mechanisms that may explain the connection between frailty and cardiovascular disease include derangements in inflammatory, hematologic, and endocrine pathways. People who are found to be clinically frail are more likely to have insulin resistance and elevated biomarkers such as C-reactive protein, D-dimer, and factor VIII.13 The inflammatory cytokine interleukin 6 is suggested as a common link between inflammation and thrombosis, perhaps contributing to the connection between cardiovascular disease and frailty. Many of these biomarkers have been linked to the pathophysiologic changes of aging, so-called “inflamm-aging” or immunosenescence, including sarcopenia, osteoporosis, and cardiovascular disease.14
ASSESSING FRAILTY IN THE CLINIC
For adults over age 70, frailty assessment is an important first step in managing cardiovascular disease risk.15 Frailty status will better identify those at risk of adverse outcomes in the short term and those who are most likely to benefit from long-term cardiovascular preventive strategies. Additionally, incorporating frailty assessment into traditional risk factor evaluation may permit appropriate intervention and prevention of a potentially modifiable risk factor.
Gait speed is a quick, easy, inexpensive, and sensitive way to assess frailty status, with excellent inter-rater and test-retest reliability, even in those with cognitive impairment.16 Slow gait speed predicts limitations in mobility, limitations in activities of daily living, and death.8,17
In a prospective study18 of 1,567 men and women, mean age 74, slow gait speed was the strongest predictor of subsequent cardiovascular events.18
Gait speed is usually measured over a distance of 4 meters (13.1 feet),17 and the patient is asked to walk comfortably in an unobstructed, marked area. An assistive walking device can be used if needed. If possible, this is repeated once after a brief recovery period, and the average is recorded.
The FRAIL scale19,20 is a simple, validated questionnaire that combines the Fried and Rockwood concepts of frailty and can be given over the phone or to patients in a waiting room. One point is given for each of the following, and people who have 3 or more are considered frail:
- Fatigue
- Resistance (inability to climb 1 flight of stairs)
- Ambulation (inability to walk 1 block)
- Illnesses (having more than 5)
- Loss of more than 5% of body weight.
Other measures of physical function such as grip strength (using a dynamometer), the Timed Up and Go test (assessing the ability to get up from a chair and walk a short distance), and Short Physical Performance Battery (assessing balance, chair stands, and walking speed) can be used to screen for frailty, but are more time-intensive than gait speed alone, and so are not always practical to use in a busy clinic.21
MANAGEMENT OF RISK FACTORS
Management of cardiovascular risk factors is best individualized as outlined below.
LOWERING HIGH BLOOD PRESSURE
The incidence of ischemic heart disease and stroke increases with age across all levels of elevated systolic and diastolic blood pressure.22 Hypertension is also associated with increased risk of cognitive decline. However, a J-shaped relationship has been observed in older adults, with increased cardiovascular events for both low and elevated blood pressure, although the clinical relevance remains controversial.23
Odden et al24 performed an observational study and found that high blood pressure was associated with an increased mortality rate in older adults with normal gait speed, while in those with slow gait speed, high blood pressure neither harmed nor helped. Those who could not walk 6 meters appeared to benefit from higher blood pressure.
HYVET (the Hypertension in the Very Elderly Trial),25 a randomized controlled trial in 3,845 community-dwelling people age 80 or older with sustained systolic blood pressure higher than 160 mm Hg, found a significant reduction in rates of stroke and all-cause mortality (relative risk [RR] 0.76, P = .007) in the treatment arm using indapamide with perindopril if necessary to reach a target blood pressure of 150/80 mm Hg.
Frailty was not assessed during the trial; however, in a reanalysis, the results did not change in those identified as frail using a Rockwood frailty index (a count of health-related deficits accumulated over the lifespan).26
SPRINT (the Systolic Blood Pressure Intervention Trial)27 randomized participants age 50 and older with systolic blood pressure of 130 to 180 mm Hg and at increased risk of cardiovascular disease to intensive treatment (goal systolic blood pressure ≤ 120 mm Hg) or standard treatment (goal systolic blood pressure ≤ 140 mm Hg). In a prespecified subgroup of 2,636 participants over age 75 (mean age 80), hazard ratios and 95% confidence intervals for adverse outcomes with intensive treatment were:
- Major cardiovascular events: HR 0.66, 95% CI 0.51–0.85
- Death: HR 0.67, 95% CI 0.49–0.91.
Over 3 years of treatment this translated into a number needed to treat of 27 to prevent 1 cardiovascular event and 41 to prevent 1 death.
Within this subgroup, the benefit was similar regardless of level of frailty (measured both by a Rockwood frailty index and by gait speed).
However, the incidence of serious adverse treatment effects such as hypotension, orthostasis, electrolyte abnormalities, and acute kidney injury was higher with intensive treatment in the frail group. Although the difference was not statistically significant, it is cause for caution. Further, the exclusion criteria (history of diabetes, heart failure, dementia, stroke, weight loss of > 10%, nursing home residence) make it difficult to generalize the SPRINT findings to the general aging population.27
Tinetti et al28 performed an observational study using a nationally representative sample of older adults. They found that receiving any antihypertensive therapy was associated with an increased risk of falls with serious adverse outcomes. The risks of adverse events related to antihypertensive therapy increased with age.
Recommendations on hypertension
Managing hypertension in frail patients at risk of cardiovascular disease requires balancing the benefits vs the risks of treatment, such as polypharmacy, falls, and orthostatic hypotension.
The Eighth Joint National Committee suggests a blood pressure goal of less than 150/90 mm Hg for all adults over age 60, and less than 140/90 mm Hg for those with a history of cardiovascular disease or diabetes.29
The American College of Cardiology/American Heart Association (ACC/AHA) guidelines on hypertension, recently released, recommend a new blood pressure target of <120/<80 as normal, with 120–129/<80 considered elevated, 130–139/80–89 stage 1 hypertension, and ≥140/≥90 as stage 2 hypertension.30 An important caveat to these guidelines is the recommendation to measure blood pressure accurately and with accurate technique, which is often not possible in many busy clinics. These guidelines are intended to apply to older adults as well, with a note that those with multiple morbidities and limited life expectancy will benefit from a shared decision that incorporates patient preferences and clinical judgment. Little guidance is given on how to incorporate frailty, although note is made that older adults who reside in assisted living facilities and nursing homes have not been represented in randomized controlled trials.30
American Diabetes Association guidelines on hypertension in patients with diabetes recommend considering functional status, frailty, and life expectancy to decide on a blood pressure goal of either 140/90 mm Hg (if fit) or 150/90 mm Hg (if frail). They do not specify how to diagnose frailty.31
Canadian guidelines say that in those with advanced frailty (ie, entirely dependent for personal care and activities of daily living) and short life expectancy (months), it is reasonable to liberalize the systolic blood pressure goal to 160 to 190 mm Hg.32
Our recommendations. In both frail and nonfrail individuals without a limited life expectancy, it is reasonable to aim for a blood pressure of at least less than 140/90 mm Hg. For those at increased risk of cardiovascular disease and able to tolerate treatment, careful lowering to 130/80 mm Hg may be considered, with close attention to side effects.
Treatment should start with the lowest possible dose, be titrated slowly, and may need to be tailored to standing blood pressure to avoid orthostatic hypotension.
Home blood pressure measurements may be beneficial in monitoring treatment.
MANAGING LIPIDS
For those over age 75, data on efficacy of statins are mixed due to the small number of older adults enrolled in randomized controlled trials of these drugs. To our knowledge, no statin trial has examined the role of frailty.
The PROSPER trial (Prospective Study of Pravastatin in the Elderly at Risk)33 randomized 5,804 patients ages 70 to 82 to receive either pravastatin or placebo. Overall, the incidence of a composite end point of major cardiovascular events was 15% lower with active treatment (P = .014). However, the mean age was 75, which does little to address the paucity of evidence for those over age 75; follow-up time was only 3 years, and subgroup analysis did not show benefit in those who did not have a history of cardiovascular disease or in women.
The JUPITER trial (Justification for the Use of Statins in Prevention: an Intervention Trial Evaluating Rosuvastatin)34 randomized 5,695 people over age 70 without cardiovascular disease to receive either rosuvastatin or placebo. Exploratory analysis showed a significant 39% reduction in all-cause mortality and major cardiovascular events with active treatment (HR 0.61, 95% CI 0.46–0.82). Over 5 years of treatment, this translates to a number needed to treat of 19 to prevent 1 major cardiovascular event and 29 to prevent 1 cardiovascular death.
The benefit of statins for primary prevention in these trials began to be apparent 2 years after treatment was initiated.
The Women’s Health Initiative,35 an observational study, found no difference in incident frailty in women older than 65 taking statins for 3 years compared with those who did not take statins
Odden et al36 found that although statin use is generally well tolerated, the risks of statin-associated functional and cognitive decline may outweigh the benefits in those older than 75. The ongoing Statin in Reducing Events in the Elderly (STAREE) trial may shed light on this issue.
Recommendations on lipid management
The ACC/AHA,3 in their 2013 guidelines, do not recommend routine statin treatment for primary prevention in those over age 75, given a lack of evidence from randomized controlled trials. For secondary prevention, ie, for those who have a history of atherosclerotic cardiovascular disease, they recommend moderate-intensity statin therapy in this age group.
Our recommendations. For patients over age 75 without cardiovascular disease or frailty and with a life expectancy of at least 2 years, consider offering a statin for primary prevention of cardiovascular disease as part of shared decision-making.
In those with known cardiovascular disease, it is reasonable to continue statin therapy except in situations where the life expectancy is less than 6 months.37
Although moderate- or high-intensity statin therapy is recommended in current guidelines, for many older adults it is prudent to consider the lowest tolerable dose to improve adherence, with close monitoring for side effects such as myalgia and weakness.
TYPE 2 DIABETES
Evidence suggests that tight glycemic control in type 2 diabetes is harmful for adults ages 55 to 79 and does not provide clear benefits for cardiovascular risk reduction, and controlling hemoglobin A1c to less than 6.0% is associated with increased mortality in older adults.38
The American Diabetes Association31 and the American Geriatrics Society39 recommend hemoglobin A1c goals of:
- 7.5% or less for older adults with 3 or more coexisting chronic illnesses requiring medical intervention (eg, arthritis, hypertension, and heart failure) and with intact cognition and function
- 8.0% or less for those identified as frail, or with multiple chronic illnesses or moderate cognitive or functional impairment
- 8.5% or 9.0% or less for those with very complex comorbidities, in long-term care, or with end-stage chronic illnesses (eg, end-stage heart failure), or with moderate to severe cognitive or functional limitation.
These guidelines do not endorse a specific frailty assessment, although the references allude to the Fried phenotype criteria, which include gait speed. An update from the American Diabetes Association provides a patient-centered approach to tailoring treatment regimens, taking into consideration the risk of hypoglycemia for each class of drugs, side effects, and cost.40
Our recommendations. Hyperglycemia remains a risk factor for cardiovascular disease in older adults and increases the risk of many geriatric conditions including delirium, dementia, frailty, and functional decline. The goal in individualizing hemoglobin A1c goals should be to avoid both hyper- and hypoglycemia.
Sulfonylureas and insulins should be used with caution, as they have the highest associated incidence of hypoglycemia of the diabetes medications.
ASPIRIN
For secondary prevention in older adults with a history of cardiovascular disease, pooled trials have consistently demonstrated a long-term benefit for aspirin use that exceeds bleeding risks, although age and frailty status were not considered.41
Aspirin for primary prevention?
The evidence for aspirin for primary prevention in older adults is mixed. Meta-analysis suggests a modest decrease in risk of nonfatal myocardial infarction but no appreciable effects on nonfatal stroke and cardiovascular death.42
The Japanese Primary Prevention Project,43 a randomized trial of low-dose aspirin for primary prevention of cardiovascular disease in adults ages 60 to 85, showed no reduction in major cardiovascular events. However, the event rate was lower than expected, the crossover rates were high, the incidence of hemorrhagic strokes was higher than in Western studies, and the trial may have been underpowered to detect the benefits of aspirin.
The US Preventive Services Task Force44 in 2016 noted that among individuals with a 10-year cardiovascular disease risk of 10% or higher based on the ACC/AHA pooled cohort equation,3 the greatest benefit of aspirin was in those ages 50 to 59. In this age group, 225 nonfatal myocardial infarctions and 84 nonfatal strokes were prevented per 10,000 men treated, with a net gain of 333 life-years. Similar findings were noted in women.
However, in those ages 60 to 69, the risks of harm begin to rise and the benefit of starting daily aspirin necessitates individualized clinical decision-making, with particular attention to bleeding risk and life expectancy.44
In those age 70 and older, data on benefit and harm are mixed. The bleeding risk of aspirin increases with age, predominantly due to gastrointestinal bleeding.44
The ongoing Aspirin in Reducing Events in Elderly trial will add to the evidence.
Aspirin recommendations for primary prevention
The American Geriatrics Society Beers Criteria do not routinely recommend aspirin use for primary prevention in those over age 80, even in those with diabetes.45
Our recommendations. In adults over age 75 who are not frail but are identified as being at moderate to high risk of cardiovascular disease using either the ACC/AHA calculator or any other risk estimator, and without a limited life expectancy, we believe it is reasonable to consider low-dose aspirin (75–100 mg daily) for primary prevention. However, there must be careful consideration particularly for those at risk of major bleeding. One approach to consider would be the addition of a proton pump inhibitor along with aspirin, though this requires further study.46
For those who have been on aspirin for primary prevention and are now older than age 80 without an adverse bleeding event, it is reasonable to stop aspirin, although risks and benefits of discontinuing aspirin should be discussed with the patient as part of shared decision-making.
In frail individuals the risks of aspirin therapy likely outweigh any benefit for primary prevention, and aspirin cannot be routinely recommended.
EXERCISE AND WEIGHT MANAGEMENT
A low body mass index is often associated with frailty, and weight loss may be a marker of underlying illness, which increases the risk of poor outcomes. However, those with an elevated body mass index and increased adiposity are in fact more likely to be frail (using the Fried physical phenotype definition) than those with a low body mass index,47 due in part to unrecognized sarcopenic obesity, ie, replacement of lean muscle with fat.
Physical activity is currently the only intervention known to improve frailty.5
Physical activity and a balanced diet are just as important in older adults, including those with reduced functional ability and multiple comorbid conditions, as in younger individuals.
A trial in frail long-term care residents (mean age 87) found that high-intensity resistance training improved muscle strength and mobility.48 The addition of a nutritional supplement with or without exercise did not affect frailty status. In community-dwelling older adults, physical activity has also been shown to improve sarcopenia and reduce falls and hip fractures.49
Progressive resistance training has been shown to improve strength and gait speed even in those with dementia.50
Tai chi has shown promising results in reducing falls and improving balance and function in both community-dwelling older adults and those in assisted living.51,52
Exercise recommendations
The US Department of Health and Human Services53 issued physical activity guidelines in 2008 with specific recommendations for older adults that include flexibility and balance training, which have been shown to reduce falls, in addition to aerobic activities and strength training.
Our recommendations. For all older adults, particularly those who are frail, we recommend a regimen of general daily activity, balance training such as tai chi, moderate-intensity aerobics such as cycling, resistance training such as using light weights, and stretching. Sessions lasting as little as 10 minutes are beneficial.
Gait speed can be monitored in the clinic to assess improvement in function over time.
SMOKING CESSATION
Although rates of smoking are decreasing, smoking remains one of the most important cardiovascular risk factors. Smoking has been associated with increased risk of frailty and significantly increased risk of death compared with never smoking.54 Smoking cessation is beneficial even for those who quit later in life.
The US Department of Health and Human Services in 2008 released an update on tobacco use and dependence,55 with specific attention to the benefit of smoking cessation for older adults.
All counseling interventions have been shown to be effective in older adults, as has nicotine replacement. Newer medications such as varenicline should be used with caution, as the risk of side effects is higher in older patients.
NUTRITION
Samieri et al,56 in an observational study of 10,670 nurses, found that those adhering to Mediterranean-style diets during midlife had 46% increased odds of healthy aging.
The PREDIMED study (Primary Prevention of Cardiovascular Disease With a Mediterranean Diet)57 in adults ages 55 to 80 showed the Mediterranean diet supplemented with olive oil and nuts reduced the incidence of major cardiovascular disease.
Leon-Munoz et al.58 A prospective study of 1,815 community-dwelling older adults followed for 3.5 years in Spain demonstrated that adhering to a Mediterranean diet was associated with a lower incidence of frailty (P = .002) and a lower risk of slow gait speed (OR 0.53, 95% CI 0.35–0.79). Interestingly, this study also found a protective association between fish and fruit consumption and frailty.
Our recommendations. A well-balanced, diverse diet rich in whole grains, fruits, vegetables, nuts, fish, and healthy fats (polyunsaturated fatty acids), with a moderate amount of lean meats, is recommended to prevent heart disease. However, poor dental health may limit the ability of older individuals to adhere to such diets, and modifications may be needed. Additionally, age-related changes in taste and smell may contribute to poor nutrition and unintended weight loss.59 Involving a nutritionist and social worker in the patient care team should be considered especially as poor nutrition may be a sign of cognitive impairment, functional decline, and frailty.
SPECIAL CONSIDERATIONS
Special considerations when managing cardiovascular risk in the older adult include polypharmacy, multimorbidity, quality of life, and the patient’s personal preferences.
Polypharmacy, defined as taking more than 5 medications, is associated with an increased risk of adverse drug events, falls, fractures, decreased adherence, and “prescribing cascade”— prescribing more drugs to treat side effects of the first drug (eg, adding hypertensive medications to treat hypertension induced by nonsteroidal anti-inflammatory drugs).60 This is particularly important when considering adding additional medications. If a statin will be the 20th pill, it may be less beneficial and more likely to lead to additional adverse effects than if it is the fifth medication.
Patient preferences are critically important, particularly when adding or removing medications. Interventions should include a detailed medication review for appropriate prescribing and deprescribing, referral to a pharmacist, and engaging the patient’s support system.
Multimorbidity. Many older individuals have multiple chronic illnesses. The interaction of multiple conditions must be considered in creating a comprehensive plan, including prognosis, patient preference, available evidence, treatment interactions, and risks and benefits.
Quality of life. Outlook on life and choices made regarding prolongation vs quality of life may be different for the older patient than the younger patient.
Personal preferences. Although interventions such as high-intensity statins for a robust 85-year-old may be appropriate, the individual can choose to forgo any treatment. It is important to explore the patient’s goals of care and advanced directives as part of shared decision-making when building a patient-centered prevention plan.61
ONE SIZE DOES NOT FIT ALL
The heterogeneity of aging rules out a one-size-fits-all recommendation for cardiovascular disease prevention and management of cardiovascular risk factors in older adults.
There is significant overlap between cardiovascular risk status and frailty.
Incorporating frailty into the creation of a cardiovascular risk prescription can aid in the development of an individualized care plan for the prevention of cardiovascular disease in the aging population.
- Social Security Administration (SSA). Calculators: life expectancy. www.ssa.gov/planners/lifeexpectancy.html. Accessed December 8, 2017.
- Benjamin EJ, Blaha MJ, Chiuve SE, et al. Heart disease and stroke statistics—2017 update: a report from the American Heart Association. Circulation 2017; 135:e146–e603.
- Stone NJ, Robinson JG, Lichtenstein AH, et al; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 2014; 63:2889–2934.
- Rich MW, Chyun DA, Skolnick AH, et al; American Heart Association Older Populations Committee of the Council on Clinical Cardiology, Council on Cardiovascular and Stroke Nursing, Council on Cardiovascular Surgery and Anesthesia, and Stroke Council; American College of Cardiology; and American Geriatrics Society. Knowledge gaps in cardiovascular care of the older adult population: a scientific statement from the American Heart Association, American College of Cardiology, and American Geriatrics Society. Circulation 2016; 133:2103–2122.
- Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet 2013; 381:752–762.
- Fried LP, Tangen CM, Walston J, et al; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci 2001; 56:M146–M156.
- Rockwood K, Mitnitski A. Frailty in relation to the accumulation of deficits. J Gerontol A Biol Sci Med Sci 2007; 62:722–727.
- Studenski S, Perera S, Patel K, et al. Gait speed and survival in older adults. JAMA 2011; 305:50–58.
- Afilalo J, Alexander KP, Mack MJ, et al. Frailty assessment in the cardiovascular care of older adults. J Am Coll Cardiol 2014; 63:747–762.
- Afilalo J, Karunananthan S, Eisenberg MJ, Alexander KP, Bergman H. Role of frailty in patients with cardiovascular disease. Am J Cardiol 2009; 103:1616–1621.
- Woods NF, LaCroix AZ, Gray SL, et al; Women’s Health Initiative. Frailty: emergence and consequences in women aged 65 and older in the Women's Health Initiative Observational Study. J Am Geriatr Soc 2005; 53:1321–1330.
- Bouillon K, Batty GD, Hamer M, et al. Cardiovascular disease risk scores in identifying future frailty: the Whitehall II prospective cohort study. Heart 2013; 99:737–742.
- Walston J, McBurnie MA, Newman A, et al; Cardiovascular Health Study. Frailty and activation of the inflammation and coagulation systems with and without clinical comorbidities: results from the Cardiovascular Health Study. Arch Intern Med 2002; 162:2333–2341.
- De Martinis M, Franceschi C, Monti D, Ginaldi L. Inflammation markers predicting frailty and mortality in the elderly. Exp Mol Pathol 2006; 80:219–227.
- Morley JE. Frailty fantasia. J Am Med Dir Assoc 2017; 18:813–815.
- Munoz-Mendoza CL, Cabanero-Martinez MJ, Millan-Calenti JC, Cabrero-Garcia J, Lopez-Sanchez R, Maseda-Rodriguez A. Reliability of 4-m and 6-m walking speed tests in elderly people with cognitive impairment. Arch Gerontol Geriatr 2011; 52:e67–e70.
- Abellan van Kan G, Rolland Y, Andrieu S, et al. Gait speed at usual pace as a predictor of adverse outcomes in community-dwelling older people an International Academy on Nutrition and Aging (IANA) Task Force. J Nutr Health Aging 2009; 13:881–889.
- Sergi G, Veronese N, Fontana L, et al. Pre-frailty and risk of cardiovascular disease in elderly men and women: the Pro.V.A. study. J Am Coll Cardiol 2015; 65:976–983.
- Abellan van Kan G, Rolland Y, Bergman H, Morley JE, Kritchevsky SB, Vellas B. The I.A.N.A Task Force on frailty assessment of older people in clinical practice. J Nutr Health Aging 2008; 12:29–37.
- Morley JE, Malmstrom TK, Miller DK. A simple frailty questionnaire (FRAIL) predicts outcomes in middle-aged African Americans. J Nutr Health Aging 2012;16:601–608.
- Forman DE, Arena R, Boxer R, et al; American Heart Association Council on Clinical Cardiology; Council on Cardiovascular and Stroke Nursing; Council on Quality of Care and Outcomes Research; and Stroke Council. Prioritizing functional capacity as a principal end point for therapies oriented to older adults with cardiovascular disease: a scientific statement for healthcare professionals from the American Heart Association. Circulation 2017; 135:e894–e918.
- Lewington S, Clarke R, Qizilbash N, Peto R, Collins R; Prospective Studies Collaboration. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet 2002; 360:1903–1913.
- Mancia G, Grassi G. Aggressive blood pressure lowering is dangerous: the J-curve: pro side of the argument. Hypertension 2014; 63:29–36.
- Odden MC, Peralta CA, Haan MN, Covinsky KE. Rethinking the association of high blood pressure with mortality in elderly adults: the impact of frailty. Arch Intern Med 2012; 172:1162–1168.
- Beckett NS, Peters R, Fletcher AE, et al; HYVET Study Group. Treatment of hypertension in patients 80 years of age or older. N Engl J Med 2008; 358:1887–1898.
- Warwick J, Falaschetti E, Rockwood K, et al. No evidence that frailty modifies the positive impact of antihypertensive treatment in very elderly people: an investigation of the impact of frailty upon treatment effect in the HYpertension in the Very Elderly Trial (HYVET) study, a double-blind, placebo-controlled study of antihypertensives in people with hypertension aged 80 and over. BMC Med 2015 9;13:78.
- Williamson JD, Supiano MA, Applegate WB, et al; SPRINT Research Group. Intensive vs standard blood pressure control and cardiovascular disease outcomes in adults aged ≥ 75 years: a randomized clinical trial. JAMA 2016; 315:2673–2682.
- Tinetti ME, Han L, Lee DS, et al. Antihypertensive medications and serious fall injuries in a nationally representative sample of older adults. JAMA Intern Med 2014; 174:588–595.
- James PA, Oparil S, Carter BL, et al. 2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA 2014; 311:507–520.
- Whelton PK, Carey RM, Aronow WS, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension 2017. Nov 13 [Epub ahead of print].)
- American Diabetes Association. 11. Older adults. Diabetes Care 2017; 40(suppl 1):S99–S104.
- Mallery LH, Allen M, Fleming I, et al. Promoting higher blood pressure targets for frail older adults: a consensus guideline from Canada. Cleve Clin J Med 2014; 81:427–437.
- Shepherd J, Blauw GJ, Murphy MB, et al; PROSPER study group. PROspective Study of Pravastatin in the Elderly at Risk. Pravastatin in elderly individuals at risk of vascular disease (PROSPER): a randomised controlled trial. Lancet 2002; 360:1623–1630.
- Glynn RJ, Koenig W, Nordestgaard BG, Shepherd J, Ridker PM. Rosuvastatin for primary prevention in older persons with elevated C-reactive protein and low to average low-density lipoprotein cholesterol levels: exploratory analysis of a randomized trial. Ann Intern Med 2010; 152:488–496, W174.
- LaCroix AZ, Gray SL, Aragaki A, et al; Women’s Health Initiative. Statin use and incident frailty in women aged 65 years or older: prospective findings from the Women’s Health Initiative Observational Study. J Gerontol A Biol Sci Med Sci 2008; 63:369–375.
- Odden MC, Pletcher MJ, Coxson PG, et al. Cost-effectiveness and population impact of statins for primary prevention in adults aged 75 years or older in the United States. Ann Intern Med 2015; 162:533–541.
- Kutner JS, Blatchford PJ, Taylor DH Jr, et al. Safety and benefit of discontinuing statin therapy in the setting of advanced, life-limiting illness: a randomized clinical trial. JAMA Intern Med 2015; 175:691–700.
- Huang ES, Liu JY, Moffet HH, John PM, Karter AJ. Glycemic control, complications, and death in older diabetic patients: the diabetes and aging study. Diabetes Care 2011; 34:1329–1336.
- Kirkman MS, Briscoe VJ, Clark N, et al; Consensus Development Conference on Diabetes and Older Adults. Diabetes in older adults: a consensus report. J Am Geriatr Soc 2012; 60:2342–2356.
- Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes, 2015: a patient-centered approach: update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2015; 38:140–149.
- Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. BMJ (Clinical research ed) 2002; 324:71–86.
- Antithrombotic Trialists’ (ATT) Collaboration; Baigent C, Blackwell L, Collins R, et al. Aspirin in the primary and secondary prevention of vascular disease: collaborative meta-analysis of individual participant data from randomised trials. Lancet 2009; 373:1849–1860.
- Ikeda Y, Shimada K, Teramoto T, et al. Low-dose aspirin for primary prevention of cardiovascular events in Japanese patients 60 years or older with atherosclerotic risk factors: a randomized clinical trial. JAMA 2014; 312:2510–2520.
- Bibbins-Domingo K; US Preventive Services Task Force. Aspirin use for the primary prevention of cardiovascular disease and colorectal cancer: US Preventive Services Task Force Recommendation Statement. Ann Intern Med 2016; 164:836–845.
- American Geriatrics Society 2012 Beers Criteria Update Expert Panel. American Geriatrics Society updated Beers Criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc 2012; 60:616–631.
- Li L, Geraghty OC, Mehta Z, Rothwell PM. Age-specific risks, severity, time course, and outcome of bleeding on long-term antiplatelet treatment after vascular events: a population-based cohort study. Lancet 2017; 390:490–499.
- Barzilay JI, Blaum C, Moore T, et al. Insulin resistance and inflammation as precursors of frailty: the Cardiovascular Health Study. Arch Intern Med 2007; 167:635–641.
- Fiatarone MA, O’Neill EF, Ryan ND, et al. Exercise training and nutritional supplementation for physical frailty in very elderly people. N Engl J Med 1994; 330:1769–1775.
- Uusi-Rasi K, Patil R, Karinkanta S, et al. Exercise and vitamin D in fall prevention among older women: a randomized clinical trial. JAMA Intern Med 2015; 175:703–711.
- Hauer K, Schwenk M, Zieschang T, Essig M, Becker C, Oster P. Physical training improves motor performance in people with dementia: a randomized controlled trial. J Am Geriatr Soc 2012; 60:8–15.
- Li F, Harmer P, Fitzgerald K. Implementing an evidence-based fall prevention intervention in community senior centers. Am J Public Health 2016; 106:2026–2031.
- Manor B, Lough M, Gagnon MM, Cupples A, Wayne PM, Lipsitz LA. Functional benefits of tai chi training in senior housing facilities. J Am Geriatr Soc 2014; 62:1484–1489.
- Physical Activity Guidelines Advisory Committee report, 2008. To the Secretary of Health and Human Services. Part A: executive summary. Nutr Rev 2009; 67:114–120.
- Hubbard RE, Searle SD, Mitnitski A, Rockwood K. Effect of smoking on the accumulation of deficits, frailty and survival in older adults: a secondary analysis from the Canadian Study of Health and Aging. J Nutr Health Aging 2009; 13:468–472.
- Clinical Practice Guideline Treating Tobacco Use and Dependence 2008 Update Panel, Liaisons, and Staff. A clinical practice guideline for treating tobacco use and dependence: 2008 update. A US Public Health Service report. Am J Prev Med 2008; 35:158–176.
- Samieri C, Sun Q, Townsend MK, et al. The association between dietary patterns at midlife and health in aging: an observational study. Ann Intern Med 2013; 159:584–591.
- Estruch R, Ros E, Martinez-Gonzalez MA. Mediterranean diet for primary prevention of cardiovascular disease. N Engl J Med 2013; 369:676–677.
- Leon-Munoz LM, Guallar-Castillon P, Lopez-Garcia E, Rodriguez-Artalejo F. Mediterranean diet and risk of frailty in community-dwelling older adults. J Am Med Dir Assoc 2014; 15:899–903.
- Doty RL, Shaman P, Applebaum SL, Giberson R, Siksorski L, Rosenberg L. Smell identification ability: changes with age. Science 1984; 226:1441–1443.
- Merel SE, Paauw DS. Common drug side effects and drug-drug interactions in elderly adults in primary care. J Am Geriatr Soc 2017 Mar 21. Epub ahead of print.
- Epstein RM, Peters E. Beyond information: exploring patients’ preferences. JAMA 2009; 302:195–197.
- Social Security Administration (SSA). Calculators: life expectancy. www.ssa.gov/planners/lifeexpectancy.html. Accessed December 8, 2017.
- Benjamin EJ, Blaha MJ, Chiuve SE, et al. Heart disease and stroke statistics—2017 update: a report from the American Heart Association. Circulation 2017; 135:e146–e603.
- Stone NJ, Robinson JG, Lichtenstein AH, et al; American College of Cardiology/American Heart Association Task Force on Practice Guidelines. 2013 ACC/AHA guideline on the treatment of blood cholesterol to reduce atherosclerotic cardiovascular risk in adults: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines. J Am Coll Cardiol 2014; 63:2889–2934.
- Rich MW, Chyun DA, Skolnick AH, et al; American Heart Association Older Populations Committee of the Council on Clinical Cardiology, Council on Cardiovascular and Stroke Nursing, Council on Cardiovascular Surgery and Anesthesia, and Stroke Council; American College of Cardiology; and American Geriatrics Society. Knowledge gaps in cardiovascular care of the older adult population: a scientific statement from the American Heart Association, American College of Cardiology, and American Geriatrics Society. Circulation 2016; 133:2103–2122.
- Clegg A, Young J, Iliffe S, Rikkert MO, Rockwood K. Frailty in elderly people. Lancet 2013; 381:752–762.
- Fried LP, Tangen CM, Walston J, et al; Cardiovascular Health Study Collaborative Research Group. Frailty in older adults: evidence for a phenotype. J Gerontol A Biol Sci Med Sci 2001; 56:M146–M156.
- Rockwood K, Mitnitski A. Frailty in relation to the accumulation of deficits. J Gerontol A Biol Sci Med Sci 2007; 62:722–727.
- Studenski S, Perera S, Patel K, et al. Gait speed and survival in older adults. JAMA 2011; 305:50–58.
- Afilalo J, Alexander KP, Mack MJ, et al. Frailty assessment in the cardiovascular care of older adults. J Am Coll Cardiol 2014; 63:747–762.
- Afilalo J, Karunananthan S, Eisenberg MJ, Alexander KP, Bergman H. Role of frailty in patients with cardiovascular disease. Am J Cardiol 2009; 103:1616–1621.
- Woods NF, LaCroix AZ, Gray SL, et al; Women’s Health Initiative. Frailty: emergence and consequences in women aged 65 and older in the Women's Health Initiative Observational Study. J Am Geriatr Soc 2005; 53:1321–1330.
- Bouillon K, Batty GD, Hamer M, et al. Cardiovascular disease risk scores in identifying future frailty: the Whitehall II prospective cohort study. Heart 2013; 99:737–742.
- Walston J, McBurnie MA, Newman A, et al; Cardiovascular Health Study. Frailty and activation of the inflammation and coagulation systems with and without clinical comorbidities: results from the Cardiovascular Health Study. Arch Intern Med 2002; 162:2333–2341.
- De Martinis M, Franceschi C, Monti D, Ginaldi L. Inflammation markers predicting frailty and mortality in the elderly. Exp Mol Pathol 2006; 80:219–227.
- Morley JE. Frailty fantasia. J Am Med Dir Assoc 2017; 18:813–815.
- Munoz-Mendoza CL, Cabanero-Martinez MJ, Millan-Calenti JC, Cabrero-Garcia J, Lopez-Sanchez R, Maseda-Rodriguez A. Reliability of 4-m and 6-m walking speed tests in elderly people with cognitive impairment. Arch Gerontol Geriatr 2011; 52:e67–e70.
- Abellan van Kan G, Rolland Y, Andrieu S, et al. Gait speed at usual pace as a predictor of adverse outcomes in community-dwelling older people an International Academy on Nutrition and Aging (IANA) Task Force. J Nutr Health Aging 2009; 13:881–889.
- Sergi G, Veronese N, Fontana L, et al. Pre-frailty and risk of cardiovascular disease in elderly men and women: the Pro.V.A. study. J Am Coll Cardiol 2015; 65:976–983.
- Abellan van Kan G, Rolland Y, Bergman H, Morley JE, Kritchevsky SB, Vellas B. The I.A.N.A Task Force on frailty assessment of older people in clinical practice. J Nutr Health Aging 2008; 12:29–37.
- Morley JE, Malmstrom TK, Miller DK. A simple frailty questionnaire (FRAIL) predicts outcomes in middle-aged African Americans. J Nutr Health Aging 2012;16:601–608.
- Forman DE, Arena R, Boxer R, et al; American Heart Association Council on Clinical Cardiology; Council on Cardiovascular and Stroke Nursing; Council on Quality of Care and Outcomes Research; and Stroke Council. Prioritizing functional capacity as a principal end point for therapies oriented to older adults with cardiovascular disease: a scientific statement for healthcare professionals from the American Heart Association. Circulation 2017; 135:e894–e918.
- Lewington S, Clarke R, Qizilbash N, Peto R, Collins R; Prospective Studies Collaboration. Age-specific relevance of usual blood pressure to vascular mortality: a meta-analysis of individual data for one million adults in 61 prospective studies. Lancet 2002; 360:1903–1913.
- Mancia G, Grassi G. Aggressive blood pressure lowering is dangerous: the J-curve: pro side of the argument. Hypertension 2014; 63:29–36.
- Odden MC, Peralta CA, Haan MN, Covinsky KE. Rethinking the association of high blood pressure with mortality in elderly adults: the impact of frailty. Arch Intern Med 2012; 172:1162–1168.
- Beckett NS, Peters R, Fletcher AE, et al; HYVET Study Group. Treatment of hypertension in patients 80 years of age or older. N Engl J Med 2008; 358:1887–1898.
- Warwick J, Falaschetti E, Rockwood K, et al. No evidence that frailty modifies the positive impact of antihypertensive treatment in very elderly people: an investigation of the impact of frailty upon treatment effect in the HYpertension in the Very Elderly Trial (HYVET) study, a double-blind, placebo-controlled study of antihypertensives in people with hypertension aged 80 and over. BMC Med 2015 9;13:78.
- Williamson JD, Supiano MA, Applegate WB, et al; SPRINT Research Group. Intensive vs standard blood pressure control and cardiovascular disease outcomes in adults aged ≥ 75 years: a randomized clinical trial. JAMA 2016; 315:2673–2682.
- Tinetti ME, Han L, Lee DS, et al. Antihypertensive medications and serious fall injuries in a nationally representative sample of older adults. JAMA Intern Med 2014; 174:588–595.
- James PA, Oparil S, Carter BL, et al. 2014 evidence-based guideline for the management of high blood pressure in adults: report from the panel members appointed to the Eighth Joint National Committee (JNC 8). JAMA 2014; 311:507–520.
- Whelton PK, Carey RM, Aronow WS, et al. 2017 ACC/AHA/AAPA/ABC/ACPM/AGS/APhA/ASH/ASPC/NMA/PCNA Guideline for the Prevention, Detection, Evaluation, and Management of High Blood Pressure in Adults: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines. Hypertension 2017. Nov 13 [Epub ahead of print].)
- American Diabetes Association. 11. Older adults. Diabetes Care 2017; 40(suppl 1):S99–S104.
- Mallery LH, Allen M, Fleming I, et al. Promoting higher blood pressure targets for frail older adults: a consensus guideline from Canada. Cleve Clin J Med 2014; 81:427–437.
- Shepherd J, Blauw GJ, Murphy MB, et al; PROSPER study group. PROspective Study of Pravastatin in the Elderly at Risk. Pravastatin in elderly individuals at risk of vascular disease (PROSPER): a randomised controlled trial. Lancet 2002; 360:1623–1630.
- Glynn RJ, Koenig W, Nordestgaard BG, Shepherd J, Ridker PM. Rosuvastatin for primary prevention in older persons with elevated C-reactive protein and low to average low-density lipoprotein cholesterol levels: exploratory analysis of a randomized trial. Ann Intern Med 2010; 152:488–496, W174.
- LaCroix AZ, Gray SL, Aragaki A, et al; Women’s Health Initiative. Statin use and incident frailty in women aged 65 years or older: prospective findings from the Women’s Health Initiative Observational Study. J Gerontol A Biol Sci Med Sci 2008; 63:369–375.
- Odden MC, Pletcher MJ, Coxson PG, et al. Cost-effectiveness and population impact of statins for primary prevention in adults aged 75 years or older in the United States. Ann Intern Med 2015; 162:533–541.
- Kutner JS, Blatchford PJ, Taylor DH Jr, et al. Safety and benefit of discontinuing statin therapy in the setting of advanced, life-limiting illness: a randomized clinical trial. JAMA Intern Med 2015; 175:691–700.
- Huang ES, Liu JY, Moffet HH, John PM, Karter AJ. Glycemic control, complications, and death in older diabetic patients: the diabetes and aging study. Diabetes Care 2011; 34:1329–1336.
- Kirkman MS, Briscoe VJ, Clark N, et al; Consensus Development Conference on Diabetes and Older Adults. Diabetes in older adults: a consensus report. J Am Geriatr Soc 2012; 60:2342–2356.
- Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes, 2015: a patient-centered approach: update to a position statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care 2015; 38:140–149.
- Collaborative meta-analysis of randomised trials of antiplatelet therapy for prevention of death, myocardial infarction, and stroke in high risk patients. BMJ (Clinical research ed) 2002; 324:71–86.
- Antithrombotic Trialists’ (ATT) Collaboration; Baigent C, Blackwell L, Collins R, et al. Aspirin in the primary and secondary prevention of vascular disease: collaborative meta-analysis of individual participant data from randomised trials. Lancet 2009; 373:1849–1860.
- Ikeda Y, Shimada K, Teramoto T, et al. Low-dose aspirin for primary prevention of cardiovascular events in Japanese patients 60 years or older with atherosclerotic risk factors: a randomized clinical trial. JAMA 2014; 312:2510–2520.
- Bibbins-Domingo K; US Preventive Services Task Force. Aspirin use for the primary prevention of cardiovascular disease and colorectal cancer: US Preventive Services Task Force Recommendation Statement. Ann Intern Med 2016; 164:836–845.
- American Geriatrics Society 2012 Beers Criteria Update Expert Panel. American Geriatrics Society updated Beers Criteria for potentially inappropriate medication use in older adults. J Am Geriatr Soc 2012; 60:616–631.
- Li L, Geraghty OC, Mehta Z, Rothwell PM. Age-specific risks, severity, time course, and outcome of bleeding on long-term antiplatelet treatment after vascular events: a population-based cohort study. Lancet 2017; 390:490–499.
- Barzilay JI, Blaum C, Moore T, et al. Insulin resistance and inflammation as precursors of frailty: the Cardiovascular Health Study. Arch Intern Med 2007; 167:635–641.
- Fiatarone MA, O’Neill EF, Ryan ND, et al. Exercise training and nutritional supplementation for physical frailty in very elderly people. N Engl J Med 1994; 330:1769–1775.
- Uusi-Rasi K, Patil R, Karinkanta S, et al. Exercise and vitamin D in fall prevention among older women: a randomized clinical trial. JAMA Intern Med 2015; 175:703–711.
- Hauer K, Schwenk M, Zieschang T, Essig M, Becker C, Oster P. Physical training improves motor performance in people with dementia: a randomized controlled trial. J Am Geriatr Soc 2012; 60:8–15.
- Li F, Harmer P, Fitzgerald K. Implementing an evidence-based fall prevention intervention in community senior centers. Am J Public Health 2016; 106:2026–2031.
- Manor B, Lough M, Gagnon MM, Cupples A, Wayne PM, Lipsitz LA. Functional benefits of tai chi training in senior housing facilities. J Am Geriatr Soc 2014; 62:1484–1489.
- Physical Activity Guidelines Advisory Committee report, 2008. To the Secretary of Health and Human Services. Part A: executive summary. Nutr Rev 2009; 67:114–120.
- Hubbard RE, Searle SD, Mitnitski A, Rockwood K. Effect of smoking on the accumulation of deficits, frailty and survival in older adults: a secondary analysis from the Canadian Study of Health and Aging. J Nutr Health Aging 2009; 13:468–472.
- Clinical Practice Guideline Treating Tobacco Use and Dependence 2008 Update Panel, Liaisons, and Staff. A clinical practice guideline for treating tobacco use and dependence: 2008 update. A US Public Health Service report. Am J Prev Med 2008; 35:158–176.
- Samieri C, Sun Q, Townsend MK, et al. The association between dietary patterns at midlife and health in aging: an observational study. Ann Intern Med 2013; 159:584–591.
- Estruch R, Ros E, Martinez-Gonzalez MA. Mediterranean diet for primary prevention of cardiovascular disease. N Engl J Med 2013; 369:676–677.
- Leon-Munoz LM, Guallar-Castillon P, Lopez-Garcia E, Rodriguez-Artalejo F. Mediterranean diet and risk of frailty in community-dwelling older adults. J Am Med Dir Assoc 2014; 15:899–903.
- Doty RL, Shaman P, Applebaum SL, Giberson R, Siksorski L, Rosenberg L. Smell identification ability: changes with age. Science 1984; 226:1441–1443.
- Merel SE, Paauw DS. Common drug side effects and drug-drug interactions in elderly adults in primary care. J Am Geriatr Soc 2017 Mar 21. Epub ahead of print.
- Epstein RM, Peters E. Beyond information: exploring patients’ preferences. JAMA 2009; 302:195–197.
KEY POINTS
- With the aging of the population, individualized prevention strategies must incorporate geriatric syndromes such as frailty.
- However, current guidelines and available evidence for cardiovascular disease prevention strategies have not incorporated frailty or make no recommendation at all for those over age 75.
- Four-meter gait speed, a simple measure of physical function and a proxy for frailty, can be used clinically to diagnose frailty.
