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CABG best for diabetes patients with CKD – or is it?
ROME – The use of coronary artery bypass graft surgery for revascularization in patients with multivessel CAD and comorbid diabetes plus chronic kidney disease was associated with a significantly lower risk of major cardiovascular and cerebrovascular events than was PCI with first-generation drug-eluting stents in a new secondary analysis from the landmark FREEDOM trial.
“The reason for this presentation is that even though chronic kidney disease is common in patients with diabetes, until now there has not been a large study of the efficacy and safety of coronary revascularization with drug-eluting stents versus CABG in this population in a randomized trial cohort,” explained Usman Baber, MD, who reported the results at the annual congress of the European Society of Cardiology.
FREEDOM (Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease) randomized 1,900 diabetic patients with multivessel CAD to PCI or CABG. As previously reported, CABG proved superior to PCI, with a significantly lower rate of the composite primary endpoint composed of all-cause mortality, MI, or stroke (N Engl J Med. 2012 Dec 20;367[25]:2375-84).
Dr. Baber presented a post hoc analysis of the 451 FREEDOM participants with baseline comorbid chronic kidney disease (CKD). Their mean SYNTAX score was 27, and their mean baseline estimated glomerular filtration rate was 44 mL/min per 1.73 m2, indicative of mild to moderate CKD.
“Only 28 patients in the FREEDOM trial had an estimated GFR below 30, therefore we can’t make any inferences about revascularization in that setting, which I think is a completely different population,” he noted.
The 5-year rate of major adverse cardiovascular and cerebrovascular events in patients with CKD was 26% in the CABG group, an absolute 9.4% less than the 35.6% rate in subjects randomized to PCI.
Roughly one-quarter of FREEDOM participants had CKD. They fared significantly worse than did those without CKD. The 5-year incidence of major adverse cardiovascular and cerebrovascular events was 30.8% in patients with CKD and 20.1% in patients without renal impairment. In a multivariate analysis adjusted for age, gender, hypertension, peripheral vascular disease, and other potential confounders, the risk of all-cause mortality was twofold higher in the CKD group. Their risk of cardiac death was increased 1.8-fold, and they were at 1.9-fold increased risk for stroke. Interestingly, however, the acute MI risk did not differ between patients with or without CKD, Dr. Baber observed.
Drilling deeper into the data, the cardiologist reported that CABG was associated with significantly lower rates of MI and a nonsignificant trend for fewer deaths, but with a significantly higher stroke rate than PCI.
One audience member rose to complain that this information won’t be helpful in counseling his diabetic patients with CKD and multivessel CAD because the choices look so grim: a higher risk of MI with percutaneous therapy, and a greater risk of stroke with surgery.
Dr. Baber replied by pointing out that the 10.8% absolute reduction in the risk of MI with CABG compared with PCI was more than twice as large as the absolute 4.6% increase in stroke risk with surgery.
“Most people would say that a heart attack is an inconvenience, and a stroke is a life-changing experience for them and their family,” said session cochair Kim A. Williams, MD, professor of medicine and chairman of cardiology at Rush University Medical Center in Chicago.
At that, Dr. Baber backtracked a bit, observing that since this was a post hoc analysis, the FREEDOM findings in patients with CKD must be viewed as hypothesis-generating rather than definitive. And, of course, contemporary second-generation drug-eluting stents have a better risk/benefit profile than do those used in FREEDOM.
“The number needed to treat/number needed to harm ratio for CABG and PCI probably ends up being roughly equal. The pertinence of an analysis like this is if you look at real-world registry-based data, you find a therapeutic nihilism that’s highly prevalent in CKD patients, where many patients who might benefit are not provided with revascularization therapy. It’s clear that we as clinicians – either because we don’t know there is a benefit or we are too concerned about potential harm – deprive patients of a treatment that might be beneficial. This analysis makes clinicians who might be concerned feel somewhat comforted that there is not unacceptable harm and that there is benefit,” Dr. Baber said.
Follow-up of FREEDOM participants continues and will be the subject of future reports, he added.
The FREEDOM trial was sponsored by the National Heart, Lung and Blood Institute. Dr. Baber reported having no financial conflicts of interest.
ROME – The use of coronary artery bypass graft surgery for revascularization in patients with multivessel CAD and comorbid diabetes plus chronic kidney disease was associated with a significantly lower risk of major cardiovascular and cerebrovascular events than was PCI with first-generation drug-eluting stents in a new secondary analysis from the landmark FREEDOM trial.
“The reason for this presentation is that even though chronic kidney disease is common in patients with diabetes, until now there has not been a large study of the efficacy and safety of coronary revascularization with drug-eluting stents versus CABG in this population in a randomized trial cohort,” explained Usman Baber, MD, who reported the results at the annual congress of the European Society of Cardiology.
FREEDOM (Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease) randomized 1,900 diabetic patients with multivessel CAD to PCI or CABG. As previously reported, CABG proved superior to PCI, with a significantly lower rate of the composite primary endpoint composed of all-cause mortality, MI, or stroke (N Engl J Med. 2012 Dec 20;367[25]:2375-84).
Dr. Baber presented a post hoc analysis of the 451 FREEDOM participants with baseline comorbid chronic kidney disease (CKD). Their mean SYNTAX score was 27, and their mean baseline estimated glomerular filtration rate was 44 mL/min per 1.73 m2, indicative of mild to moderate CKD.
“Only 28 patients in the FREEDOM trial had an estimated GFR below 30, therefore we can’t make any inferences about revascularization in that setting, which I think is a completely different population,” he noted.
The 5-year rate of major adverse cardiovascular and cerebrovascular events in patients with CKD was 26% in the CABG group, an absolute 9.4% less than the 35.6% rate in subjects randomized to PCI.
Roughly one-quarter of FREEDOM participants had CKD. They fared significantly worse than did those without CKD. The 5-year incidence of major adverse cardiovascular and cerebrovascular events was 30.8% in patients with CKD and 20.1% in patients without renal impairment. In a multivariate analysis adjusted for age, gender, hypertension, peripheral vascular disease, and other potential confounders, the risk of all-cause mortality was twofold higher in the CKD group. Their risk of cardiac death was increased 1.8-fold, and they were at 1.9-fold increased risk for stroke. Interestingly, however, the acute MI risk did not differ between patients with or without CKD, Dr. Baber observed.
Drilling deeper into the data, the cardiologist reported that CABG was associated with significantly lower rates of MI and a nonsignificant trend for fewer deaths, but with a significantly higher stroke rate than PCI.
One audience member rose to complain that this information won’t be helpful in counseling his diabetic patients with CKD and multivessel CAD because the choices look so grim: a higher risk of MI with percutaneous therapy, and a greater risk of stroke with surgery.
Dr. Baber replied by pointing out that the 10.8% absolute reduction in the risk of MI with CABG compared with PCI was more than twice as large as the absolute 4.6% increase in stroke risk with surgery.
“Most people would say that a heart attack is an inconvenience, and a stroke is a life-changing experience for them and their family,” said session cochair Kim A. Williams, MD, professor of medicine and chairman of cardiology at Rush University Medical Center in Chicago.
At that, Dr. Baber backtracked a bit, observing that since this was a post hoc analysis, the FREEDOM findings in patients with CKD must be viewed as hypothesis-generating rather than definitive. And, of course, contemporary second-generation drug-eluting stents have a better risk/benefit profile than do those used in FREEDOM.
“The number needed to treat/number needed to harm ratio for CABG and PCI probably ends up being roughly equal. The pertinence of an analysis like this is if you look at real-world registry-based data, you find a therapeutic nihilism that’s highly prevalent in CKD patients, where many patients who might benefit are not provided with revascularization therapy. It’s clear that we as clinicians – either because we don’t know there is a benefit or we are too concerned about potential harm – deprive patients of a treatment that might be beneficial. This analysis makes clinicians who might be concerned feel somewhat comforted that there is not unacceptable harm and that there is benefit,” Dr. Baber said.
Follow-up of FREEDOM participants continues and will be the subject of future reports, he added.
The FREEDOM trial was sponsored by the National Heart, Lung and Blood Institute. Dr. Baber reported having no financial conflicts of interest.
ROME – The use of coronary artery bypass graft surgery for revascularization in patients with multivessel CAD and comorbid diabetes plus chronic kidney disease was associated with a significantly lower risk of major cardiovascular and cerebrovascular events than was PCI with first-generation drug-eluting stents in a new secondary analysis from the landmark FREEDOM trial.
“The reason for this presentation is that even though chronic kidney disease is common in patients with diabetes, until now there has not been a large study of the efficacy and safety of coronary revascularization with drug-eluting stents versus CABG in this population in a randomized trial cohort,” explained Usman Baber, MD, who reported the results at the annual congress of the European Society of Cardiology.
FREEDOM (Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease) randomized 1,900 diabetic patients with multivessel CAD to PCI or CABG. As previously reported, CABG proved superior to PCI, with a significantly lower rate of the composite primary endpoint composed of all-cause mortality, MI, or stroke (N Engl J Med. 2012 Dec 20;367[25]:2375-84).
Dr. Baber presented a post hoc analysis of the 451 FREEDOM participants with baseline comorbid chronic kidney disease (CKD). Their mean SYNTAX score was 27, and their mean baseline estimated glomerular filtration rate was 44 mL/min per 1.73 m2, indicative of mild to moderate CKD.
“Only 28 patients in the FREEDOM trial had an estimated GFR below 30, therefore we can’t make any inferences about revascularization in that setting, which I think is a completely different population,” he noted.
The 5-year rate of major adverse cardiovascular and cerebrovascular events in patients with CKD was 26% in the CABG group, an absolute 9.4% less than the 35.6% rate in subjects randomized to PCI.
Roughly one-quarter of FREEDOM participants had CKD. They fared significantly worse than did those without CKD. The 5-year incidence of major adverse cardiovascular and cerebrovascular events was 30.8% in patients with CKD and 20.1% in patients without renal impairment. In a multivariate analysis adjusted for age, gender, hypertension, peripheral vascular disease, and other potential confounders, the risk of all-cause mortality was twofold higher in the CKD group. Their risk of cardiac death was increased 1.8-fold, and they were at 1.9-fold increased risk for stroke. Interestingly, however, the acute MI risk did not differ between patients with or without CKD, Dr. Baber observed.
Drilling deeper into the data, the cardiologist reported that CABG was associated with significantly lower rates of MI and a nonsignificant trend for fewer deaths, but with a significantly higher stroke rate than PCI.
One audience member rose to complain that this information won’t be helpful in counseling his diabetic patients with CKD and multivessel CAD because the choices look so grim: a higher risk of MI with percutaneous therapy, and a greater risk of stroke with surgery.
Dr. Baber replied by pointing out that the 10.8% absolute reduction in the risk of MI with CABG compared with PCI was more than twice as large as the absolute 4.6% increase in stroke risk with surgery.
“Most people would say that a heart attack is an inconvenience, and a stroke is a life-changing experience for them and their family,” said session cochair Kim A. Williams, MD, professor of medicine and chairman of cardiology at Rush University Medical Center in Chicago.
At that, Dr. Baber backtracked a bit, observing that since this was a post hoc analysis, the FREEDOM findings in patients with CKD must be viewed as hypothesis-generating rather than definitive. And, of course, contemporary second-generation drug-eluting stents have a better risk/benefit profile than do those used in FREEDOM.
“The number needed to treat/number needed to harm ratio for CABG and PCI probably ends up being roughly equal. The pertinence of an analysis like this is if you look at real-world registry-based data, you find a therapeutic nihilism that’s highly prevalent in CKD patients, where many patients who might benefit are not provided with revascularization therapy. It’s clear that we as clinicians – either because we don’t know there is a benefit or we are too concerned about potential harm – deprive patients of a treatment that might be beneficial. This analysis makes clinicians who might be concerned feel somewhat comforted that there is not unacceptable harm and that there is benefit,” Dr. Baber said.
Follow-up of FREEDOM participants continues and will be the subject of future reports, he added.
The FREEDOM trial was sponsored by the National Heart, Lung and Blood Institute. Dr. Baber reported having no financial conflicts of interest.
AT THE ESC CONGRESS 2016
Key clinical point: Coronary artery bypass graft surgery resulted in fewer myocardial infarctions but more strokes than did percutaneous coronary intervention at 5 years of follow-up in diabetic patients with multivessel coronary artery disease and chronic kidney disease.
Major finding: The cumulative MI rates in patients randomized to CABG versus PCI were 4.5% and 15.3%, respectively, while the stroke rates were 8.2% versus 3.6%.
Data source: A post hoc analysis of clinical outcomes in 451 diabetic patients with multivessel CAD and chronic kidney disease who were randomized to CABG or PCI in the prospective multicenter FREEDOM trial.
Disclosures: The FREEDOM trial was sponsored by the National Heart, Lung, and Blood Institute. The presenter reported having no financial conflicts of interest.
Aspirin not prescribed appropriately to cut cardiovascular risk in diabetes
MUNICH – Many patients with diabetes who could benefit from low-dose aspirin therapy may not be getting it – and many who are getting aspirin should not be, according to data presented at the annual meeting of the European Association for the Study of Diabetes.
A large, randomized trial concluded that 21% of diabetes patients who qualified for aspirin therapy for cardiovascular risk reduction were not getting it, and that it was contraindicated in almost 60% of those who were taking it, Lauren Crain, PhD, reported at the meeting.
Balancing the risks and benefits of aspirin therapy is not an easy challenge, said Dr. Crain, a health behavior researcher at HealthPartners Institute, Minneapolis. The clinical information necessary for the assessment is “rather lengthy, and not always readily available in primary care settings,” she said, and it’s clear from this study that clinicians could use some help in this area. Unfortunately, the electronic algorithm tested, which was meant to improve appropriate aspirin prescribing, didn’t improve the situation very much.
“At the final visit in the diabetes group [after the algorithm was employed], the total proportion of patients using aspirin was higher than at the first visit,” Dr. Crain noted. “However, that was the case regardless of whether patients were over- or underusing aspirin at the first visit.”
The aspirin findings were part of a large, randomized trial testing the algorithm as a way to reduce cardiovascular risk factors. The study was conducted in 19 primary care practices.
The decision-making algorithm, Cardiovascular Wizard, uses electronic health records to identify and advise patients with uncontrolled cardiovascular risk factors. Priorities and clinical recommendations are displayed for the provider and patient in the hope of facilitating shared decision making, Dr. Crain said.
One of the Wizard’s algorithms concerns aspirin prescribing. It is programmed with data from the United States Preventive Services Task Force, and recommends aspirin if cardiovascular risk scores are high and if consistent with providing a benefit greater than the risk of gastrointestinal bleeding. Aspirin is not recommended if the benefit is determined to be low or if major contraindications are present, including anticoagulant use or history of intracerebral hemorrhage.
The tool also alerts providers to the presence of other potential risks including aspirin allergy or intolerance, history of GI bleeds or risk conditions, and the concomitant use of nonsteroidal anti-inflammatory drugs.
The study comprised 11,000 adults, 4,000 of whom had diabetes. The remainder had high-risk, reversible cardiovascular risk factors (hypertension, dyslipidemia, or tobacco use). Each group was randomized to either cardiovascular risk assessment by usual care or with the Cardiovascular Wizard program.
The aspirin substudy looked at aspirin use at the baseline visit and the patient’s final, 1-year follow-up visit. At both visits, aspirin use was documented, and the clinician used the Wizard to assess whether or not it was indicated.
At the baseline visit, 71% of the diabetes group was using aspirin. However, according to the Wizard tool, more than one-third of them should not have been taking it – and among these, 57% were doing so. Among the remaining two-thirds of patients, all of whom should have been using aspirin, 21% were not taking it, Dr. Crain said.
Among the patients with reversible high-risk factors, 27% were using aspirin. However, according to the Wizard tool, the drug was contraindicated in 34% of those patients. “Most importantly, however, among those for whom aspirin was indicated, only 25% were using it – so, we’re talking about a 75% underusage,” Dr. Crain said.
By the 1-year follow-up visit, the situation was not much changed, despite the tool’s recommendations. Among those with diabetes, 56% in the usual care group and 60% in Wizard group were still overusing aspirin. Underuse was occurring in 21% of the usual care group and 17% of the Wizard group.
Patients with reversible high-risk factors fared a little better at 1 year, especially those who, at baseline, should have been taking aspirin but were not. Among these, 10% in the usual care group and 13% in the Wizard group had started taking aspirin.
The results were a bit of a disappointment, Dr. Crain said, but they don’t invalidate the investigators’ faith in an algorithmic advising system.
“We do think that electronic health record tools like this can help providers follow guidelines and improve the quality of their aspirin recommendations and prescribing, and hopefully reduce cardiovascular events and aspirin-related hazards,” she said. “Unfortunately, that didn’t happen here in the diabetes patients,” and the results in the second group were not stellar.
She added that the Wizard development team will be tweaking the tool to clarify some of the choices available as it guides patients and providers through the algorithm, in hopes of improving its efficacy.
Dr. Crain made no financial disclosures.
On Twitter @alz_gal
MUNICH – Many patients with diabetes who could benefit from low-dose aspirin therapy may not be getting it – and many who are getting aspirin should not be, according to data presented at the annual meeting of the European Association for the Study of Diabetes.
A large, randomized trial concluded that 21% of diabetes patients who qualified for aspirin therapy for cardiovascular risk reduction were not getting it, and that it was contraindicated in almost 60% of those who were taking it, Lauren Crain, PhD, reported at the meeting.
Balancing the risks and benefits of aspirin therapy is not an easy challenge, said Dr. Crain, a health behavior researcher at HealthPartners Institute, Minneapolis. The clinical information necessary for the assessment is “rather lengthy, and not always readily available in primary care settings,” she said, and it’s clear from this study that clinicians could use some help in this area. Unfortunately, the electronic algorithm tested, which was meant to improve appropriate aspirin prescribing, didn’t improve the situation very much.
“At the final visit in the diabetes group [after the algorithm was employed], the total proportion of patients using aspirin was higher than at the first visit,” Dr. Crain noted. “However, that was the case regardless of whether patients were over- or underusing aspirin at the first visit.”
The aspirin findings were part of a large, randomized trial testing the algorithm as a way to reduce cardiovascular risk factors. The study was conducted in 19 primary care practices.
The decision-making algorithm, Cardiovascular Wizard, uses electronic health records to identify and advise patients with uncontrolled cardiovascular risk factors. Priorities and clinical recommendations are displayed for the provider and patient in the hope of facilitating shared decision making, Dr. Crain said.
One of the Wizard’s algorithms concerns aspirin prescribing. It is programmed with data from the United States Preventive Services Task Force, and recommends aspirin if cardiovascular risk scores are high and if consistent with providing a benefit greater than the risk of gastrointestinal bleeding. Aspirin is not recommended if the benefit is determined to be low or if major contraindications are present, including anticoagulant use or history of intracerebral hemorrhage.
The tool also alerts providers to the presence of other potential risks including aspirin allergy or intolerance, history of GI bleeds or risk conditions, and the concomitant use of nonsteroidal anti-inflammatory drugs.
The study comprised 11,000 adults, 4,000 of whom had diabetes. The remainder had high-risk, reversible cardiovascular risk factors (hypertension, dyslipidemia, or tobacco use). Each group was randomized to either cardiovascular risk assessment by usual care or with the Cardiovascular Wizard program.
The aspirin substudy looked at aspirin use at the baseline visit and the patient’s final, 1-year follow-up visit. At both visits, aspirin use was documented, and the clinician used the Wizard to assess whether or not it was indicated.
At the baseline visit, 71% of the diabetes group was using aspirin. However, according to the Wizard tool, more than one-third of them should not have been taking it – and among these, 57% were doing so. Among the remaining two-thirds of patients, all of whom should have been using aspirin, 21% were not taking it, Dr. Crain said.
Among the patients with reversible high-risk factors, 27% were using aspirin. However, according to the Wizard tool, the drug was contraindicated in 34% of those patients. “Most importantly, however, among those for whom aspirin was indicated, only 25% were using it – so, we’re talking about a 75% underusage,” Dr. Crain said.
By the 1-year follow-up visit, the situation was not much changed, despite the tool’s recommendations. Among those with diabetes, 56% in the usual care group and 60% in Wizard group were still overusing aspirin. Underuse was occurring in 21% of the usual care group and 17% of the Wizard group.
Patients with reversible high-risk factors fared a little better at 1 year, especially those who, at baseline, should have been taking aspirin but were not. Among these, 10% in the usual care group and 13% in the Wizard group had started taking aspirin.
The results were a bit of a disappointment, Dr. Crain said, but they don’t invalidate the investigators’ faith in an algorithmic advising system.
“We do think that electronic health record tools like this can help providers follow guidelines and improve the quality of their aspirin recommendations and prescribing, and hopefully reduce cardiovascular events and aspirin-related hazards,” she said. “Unfortunately, that didn’t happen here in the diabetes patients,” and the results in the second group were not stellar.
She added that the Wizard development team will be tweaking the tool to clarify some of the choices available as it guides patients and providers through the algorithm, in hopes of improving its efficacy.
Dr. Crain made no financial disclosures.
On Twitter @alz_gal
MUNICH – Many patients with diabetes who could benefit from low-dose aspirin therapy may not be getting it – and many who are getting aspirin should not be, according to data presented at the annual meeting of the European Association for the Study of Diabetes.
A large, randomized trial concluded that 21% of diabetes patients who qualified for aspirin therapy for cardiovascular risk reduction were not getting it, and that it was contraindicated in almost 60% of those who were taking it, Lauren Crain, PhD, reported at the meeting.
Balancing the risks and benefits of aspirin therapy is not an easy challenge, said Dr. Crain, a health behavior researcher at HealthPartners Institute, Minneapolis. The clinical information necessary for the assessment is “rather lengthy, and not always readily available in primary care settings,” she said, and it’s clear from this study that clinicians could use some help in this area. Unfortunately, the electronic algorithm tested, which was meant to improve appropriate aspirin prescribing, didn’t improve the situation very much.
“At the final visit in the diabetes group [after the algorithm was employed], the total proportion of patients using aspirin was higher than at the first visit,” Dr. Crain noted. “However, that was the case regardless of whether patients were over- or underusing aspirin at the first visit.”
The aspirin findings were part of a large, randomized trial testing the algorithm as a way to reduce cardiovascular risk factors. The study was conducted in 19 primary care practices.
The decision-making algorithm, Cardiovascular Wizard, uses electronic health records to identify and advise patients with uncontrolled cardiovascular risk factors. Priorities and clinical recommendations are displayed for the provider and patient in the hope of facilitating shared decision making, Dr. Crain said.
One of the Wizard’s algorithms concerns aspirin prescribing. It is programmed with data from the United States Preventive Services Task Force, and recommends aspirin if cardiovascular risk scores are high and if consistent with providing a benefit greater than the risk of gastrointestinal bleeding. Aspirin is not recommended if the benefit is determined to be low or if major contraindications are present, including anticoagulant use or history of intracerebral hemorrhage.
The tool also alerts providers to the presence of other potential risks including aspirin allergy or intolerance, history of GI bleeds or risk conditions, and the concomitant use of nonsteroidal anti-inflammatory drugs.
The study comprised 11,000 adults, 4,000 of whom had diabetes. The remainder had high-risk, reversible cardiovascular risk factors (hypertension, dyslipidemia, or tobacco use). Each group was randomized to either cardiovascular risk assessment by usual care or with the Cardiovascular Wizard program.
The aspirin substudy looked at aspirin use at the baseline visit and the patient’s final, 1-year follow-up visit. At both visits, aspirin use was documented, and the clinician used the Wizard to assess whether or not it was indicated.
At the baseline visit, 71% of the diabetes group was using aspirin. However, according to the Wizard tool, more than one-third of them should not have been taking it – and among these, 57% were doing so. Among the remaining two-thirds of patients, all of whom should have been using aspirin, 21% were not taking it, Dr. Crain said.
Among the patients with reversible high-risk factors, 27% were using aspirin. However, according to the Wizard tool, the drug was contraindicated in 34% of those patients. “Most importantly, however, among those for whom aspirin was indicated, only 25% were using it – so, we’re talking about a 75% underusage,” Dr. Crain said.
By the 1-year follow-up visit, the situation was not much changed, despite the tool’s recommendations. Among those with diabetes, 56% in the usual care group and 60% in Wizard group were still overusing aspirin. Underuse was occurring in 21% of the usual care group and 17% of the Wizard group.
Patients with reversible high-risk factors fared a little better at 1 year, especially those who, at baseline, should have been taking aspirin but were not. Among these, 10% in the usual care group and 13% in the Wizard group had started taking aspirin.
The results were a bit of a disappointment, Dr. Crain said, but they don’t invalidate the investigators’ faith in an algorithmic advising system.
“We do think that electronic health record tools like this can help providers follow guidelines and improve the quality of their aspirin recommendations and prescribing, and hopefully reduce cardiovascular events and aspirin-related hazards,” she said. “Unfortunately, that didn’t happen here in the diabetes patients,” and the results in the second group were not stellar.
She added that the Wizard development team will be tweaking the tool to clarify some of the choices available as it guides patients and providers through the algorithm, in hopes of improving its efficacy.
Dr. Crain made no financial disclosures.
On Twitter @alz_gal
AT EASD 2016
Key clinical point: Many diabetes patients who should be taking aspirin for cardiovascular risk reduction are not doing so, and many who should not be taking it are.
Major finding: Aspirin was underused in 21% of diabetes patients and overused in 57% of patients.
Data source: A randomized study of 11,000 patients.
Disclosures: Dr. Lauren Crain had no financial disclosures.
AATS Submission Opportunities
Current and future CT surgery division chiefs/department chairs are invited to apply for the AATS Leadership Academy Program.
Friday, April 28, 2017
AATS Centennial
Boston, MA
This intensive, didactic and interactive program brings together up to 20 international surgeons who have demonstrated significant promise as potential future division chiefs or have recent assumed that role. The program provides participants with administrative, interpersonal, mentoring and negotiating skills, as well as the opportunity to network with well-known thoracic surgeon leaders and potential mentors.
Deadline: November 30, 2016
Qualifications/More Information
Don’t miss the opportunity to submit to one of these AATS scholarship programs.
Deadline: January 20, 2017
AATS Member for a Day
North American medical students, and general and up to third year integrated CT Surgery
(I-6) surgery residents can accompany an AATS Member during portions of the AATS Centennial as an AATS Member for a Day.
The meeting takes place April 29-May 3, 2017 in Boston, MA.
Those selected will receive free hotel accommodations for three to four night in an AATS Centennial hotel. They will also be given a $250 meal and $500 travel stipend at the end of the meeting.
Eligibility/More information
Summer Internship Opportunity for First/Second Year Medical Students
First and second year medical students can spend the summer being exposed to cardiothoracic surgery thanks to the AATS Summer Intern Scholarship. For eight weeks (June – September), students will work in the CT department of an AATS member.
Those chosen receive $2,500 for living expenses. They also will be able to attend the AATS Centennial gratis.
The meeting takes place April 29 – May 3, 2017 in Boston, MA.
More information
AATS Resident Poster Competition
International cardiothoracic surgery residents and/or congenital heart surgery fellows: Take advantage of this opportunity to represent your institution and present a scientific poster of your clinical/investigative research at the AATS Centennial.
The meeting will take place April 29 - May 3, 2017 in Boston, MA.
Awardee institutions get a $500 stipend to offset meal/travel costs. Each winner receives free registration to the AATS Centennial and access to the Skills Course (April 30) and Postgraduate Course (May 1).
More information
Non-MD CT Surgical Team Scientific Poster Competition
Non-MD cardiothoracic team professionals can submit a scientific poster for the Perioperative/Team-Based Care Poster Competition.
Winning posters will be displayed at the AATS Centennial, April 29 – May 3, 2017 in Boston, MA.
The competition winner will receive a $1,000 stipend to offset travel and accommodation costs.
More information
Share:
Current and future CT surgery division chiefs/department chairs are invited to apply for the AATS Leadership Academy Program.
Friday, April 28, 2017
AATS Centennial
Boston, MA
This intensive, didactic and interactive program brings together up to 20 international surgeons who have demonstrated significant promise as potential future division chiefs or have recent assumed that role. The program provides participants with administrative, interpersonal, mentoring and negotiating skills, as well as the opportunity to network with well-known thoracic surgeon leaders and potential mentors.
Deadline: November 30, 2016
Qualifications/More Information
Don’t miss the opportunity to submit to one of these AATS scholarship programs.
Deadline: January 20, 2017
AATS Member for a Day
North American medical students, and general and up to third year integrated CT Surgery
(I-6) surgery residents can accompany an AATS Member during portions of the AATS Centennial as an AATS Member for a Day.
The meeting takes place April 29-May 3, 2017 in Boston, MA.
Those selected will receive free hotel accommodations for three to four night in an AATS Centennial hotel. They will also be given a $250 meal and $500 travel stipend at the end of the meeting.
Eligibility/More information
Summer Internship Opportunity for First/Second Year Medical Students
First and second year medical students can spend the summer being exposed to cardiothoracic surgery thanks to the AATS Summer Intern Scholarship. For eight weeks (June – September), students will work in the CT department of an AATS member.
Those chosen receive $2,500 for living expenses. They also will be able to attend the AATS Centennial gratis.
The meeting takes place April 29 – May 3, 2017 in Boston, MA.
More information
AATS Resident Poster Competition
International cardiothoracic surgery residents and/or congenital heart surgery fellows: Take advantage of this opportunity to represent your institution and present a scientific poster of your clinical/investigative research at the AATS Centennial.
The meeting will take place April 29 - May 3, 2017 in Boston, MA.
Awardee institutions get a $500 stipend to offset meal/travel costs. Each winner receives free registration to the AATS Centennial and access to the Skills Course (April 30) and Postgraduate Course (May 1).
More information
Non-MD CT Surgical Team Scientific Poster Competition
Non-MD cardiothoracic team professionals can submit a scientific poster for the Perioperative/Team-Based Care Poster Competition.
Winning posters will be displayed at the AATS Centennial, April 29 – May 3, 2017 in Boston, MA.
The competition winner will receive a $1,000 stipend to offset travel and accommodation costs.
More information
Share:
Current and future CT surgery division chiefs/department chairs are invited to apply for the AATS Leadership Academy Program.
Friday, April 28, 2017
AATS Centennial
Boston, MA
This intensive, didactic and interactive program brings together up to 20 international surgeons who have demonstrated significant promise as potential future division chiefs or have recent assumed that role. The program provides participants with administrative, interpersonal, mentoring and negotiating skills, as well as the opportunity to network with well-known thoracic surgeon leaders and potential mentors.
Deadline: November 30, 2016
Qualifications/More Information
Don’t miss the opportunity to submit to one of these AATS scholarship programs.
Deadline: January 20, 2017
AATS Member for a Day
North American medical students, and general and up to third year integrated CT Surgery
(I-6) surgery residents can accompany an AATS Member during portions of the AATS Centennial as an AATS Member for a Day.
The meeting takes place April 29-May 3, 2017 in Boston, MA.
Those selected will receive free hotel accommodations for three to four night in an AATS Centennial hotel. They will also be given a $250 meal and $500 travel stipend at the end of the meeting.
Eligibility/More information
Summer Internship Opportunity for First/Second Year Medical Students
First and second year medical students can spend the summer being exposed to cardiothoracic surgery thanks to the AATS Summer Intern Scholarship. For eight weeks (June – September), students will work in the CT department of an AATS member.
Those chosen receive $2,500 for living expenses. They also will be able to attend the AATS Centennial gratis.
The meeting takes place April 29 – May 3, 2017 in Boston, MA.
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AATS Resident Poster Competition
International cardiothoracic surgery residents and/or congenital heart surgery fellows: Take advantage of this opportunity to represent your institution and present a scientific poster of your clinical/investigative research at the AATS Centennial.
The meeting will take place April 29 - May 3, 2017 in Boston, MA.
Awardee institutions get a $500 stipend to offset meal/travel costs. Each winner receives free registration to the AATS Centennial and access to the Skills Course (April 30) and Postgraduate Course (May 1).
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Non-MD CT Surgical Team Scientific Poster Competition
Non-MD cardiothoracic team professionals can submit a scientific poster for the Perioperative/Team-Based Care Poster Competition.
Winning posters will be displayed at the AATS Centennial, April 29 – May 3, 2017 in Boston, MA.
The competition winner will receive a $1,000 stipend to offset travel and accommodation costs.
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Has mystery of exercise-intolerant chronic thromboembolic disease been solved?
The pathophysiology of exercise intolerance in chronic thromboembolic disease (CTED) and mechanism of improvement after pulmonary endarterectomy have not been well understood, but researchers in the Netherlands have identified those key clinical characteristics of exercise intolerance as well as the mechanisms to response of treatment.
This is the first study to identify the pathophysiology of the exercise intolerance—abnormal pulmonary vascular response—and the underlying mechanism for the pulmonary improvement, Coen van Kan, MD, of Our Lady’s Hospital in Amsterdam and colleagues at the University of Amsterdam reported in the September issue of the Journal of Thoracic and Cardiovascular Surgery (2016;152[3]:763-71).
“Our observations point to a hampered pulmonary vascular response and decreased ventilatory efficiency as underlying pathophysiological mechanisms to explain the exercise limitation observed in patients with CTED,” Dr. van Kan and colleagues wrote. “The clinically significant symptomatic improvement after surgery was shown to be related to significant improvements in both circulatory and ventilatory responses indicative for an improved right ventricle stroke volume during exercise and ventilatory efficiency.”
The researchers studied 14 patients with symptomatic CTED but with normal pulmonary pressures at rest. The patients underwent cardiopulmonary exercise testing (CPET) during right heart catheterization and then had noninvasive CPET 1 year later. During exercise the study subjects showed four features of abnormal pulmonary vascular responses:
• Steep mean pulmonary artery pressure/cardiac output (2.7 mm Hg/min per L).
• Low pulmonary vascular compliance (2.8 mL/mm Hg).
• Mean pulmonary artery pressure (mPAP)/cardiac output slope correlated with dead space ventilation (r = 0.586; P = .028).
• Ventilatory equivalents for carbon dioxide slope (r = 0.580; P = .030).
After screening for exercise-induced pulmonary hypertension, nine patients went on to have pulmonary endarterectomy (three patients had mPAP within normal limits during exercise and hence were not candidates, while two others declined surgery). All nine patients who had surgery survived, and a year afterward, their New York Heart Association functional class scores had improved from class II or II to class I in all patients. “Also, mean peak workload and mean oxygen consumption peak had increased, and the improvements observed tended to reach statistical significance,” Dr. van Kan and colleagues said.
After catheterization, improvement in exercise capacity was related to restoration of right ventricle stroke volume response, as measured by oxygen pulse improvement from 11.7 to 13.3 (P = .027) and heart rate response from 80.9 to 72 (P = .003); and a decrease in ventilatory equivalents for carbon dioxide slope from 38.2 to 32.8 (P = .014).
Dr. van Kan and coauthors had no financial relationships to disclose.
By studying subjects with symptomatic chronic thromboembolic disease and normal pulmonary pressures, Dr. van Kan and colleagues “cleverly opted to study an interesting group,” Robert B. Cameron, MD, of the University of California, Los Angeles, said in his invited commentary.
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Dr. Robert B. Cameron |
“Logically, this patient group, representing potentially early pathophysiologic CTED, could reveal more pathophysiologic information about mechanisms active during the development of chronic thromboembolic pulmonary hypertension than would be seen in patients with more end-stage disease,” Dr. Cameron said (J Thorac Cardiovasc Surg. 2016;152[3]:771-2).
The early physiologic changes in patients with CTED that Dr. van Kan and colleagues reported on may make it possible to detect chronic thromboembolic pulmonary hypertension and intervene before advance disease sets in, Dr. Cameron said. “Surgical mortality may decrease to very-low levels simply from early surgical intervention,” he said.
Although the retrospective design is a limitation of the study, “these data improve our understanding of CTED and motivate all surgeons to promote prospective trials evaluating these findings and early intervention in a disease that is notoriously difficult to understand and treat,” Dr. Cameron said.
Dr. Cameron had no financial relationships to disclose.
By studying subjects with symptomatic chronic thromboembolic disease and normal pulmonary pressures, Dr. van Kan and colleagues “cleverly opted to study an interesting group,” Robert B. Cameron, MD, of the University of California, Los Angeles, said in his invited commentary.
|
Dr. Robert B. Cameron |
“Logically, this patient group, representing potentially early pathophysiologic CTED, could reveal more pathophysiologic information about mechanisms active during the development of chronic thromboembolic pulmonary hypertension than would be seen in patients with more end-stage disease,” Dr. Cameron said (J Thorac Cardiovasc Surg. 2016;152[3]:771-2).
The early physiologic changes in patients with CTED that Dr. van Kan and colleagues reported on may make it possible to detect chronic thromboembolic pulmonary hypertension and intervene before advance disease sets in, Dr. Cameron said. “Surgical mortality may decrease to very-low levels simply from early surgical intervention,” he said.
Although the retrospective design is a limitation of the study, “these data improve our understanding of CTED and motivate all surgeons to promote prospective trials evaluating these findings and early intervention in a disease that is notoriously difficult to understand and treat,” Dr. Cameron said.
Dr. Cameron had no financial relationships to disclose.
By studying subjects with symptomatic chronic thromboembolic disease and normal pulmonary pressures, Dr. van Kan and colleagues “cleverly opted to study an interesting group,” Robert B. Cameron, MD, of the University of California, Los Angeles, said in his invited commentary.
|
Dr. Robert B. Cameron |
“Logically, this patient group, representing potentially early pathophysiologic CTED, could reveal more pathophysiologic information about mechanisms active during the development of chronic thromboembolic pulmonary hypertension than would be seen in patients with more end-stage disease,” Dr. Cameron said (J Thorac Cardiovasc Surg. 2016;152[3]:771-2).
The early physiologic changes in patients with CTED that Dr. van Kan and colleagues reported on may make it possible to detect chronic thromboembolic pulmonary hypertension and intervene before advance disease sets in, Dr. Cameron said. “Surgical mortality may decrease to very-low levels simply from early surgical intervention,” he said.
Although the retrospective design is a limitation of the study, “these data improve our understanding of CTED and motivate all surgeons to promote prospective trials evaluating these findings and early intervention in a disease that is notoriously difficult to understand and treat,” Dr. Cameron said.
Dr. Cameron had no financial relationships to disclose.
The pathophysiology of exercise intolerance in chronic thromboembolic disease (CTED) and mechanism of improvement after pulmonary endarterectomy have not been well understood, but researchers in the Netherlands have identified those key clinical characteristics of exercise intolerance as well as the mechanisms to response of treatment.
This is the first study to identify the pathophysiology of the exercise intolerance—abnormal pulmonary vascular response—and the underlying mechanism for the pulmonary improvement, Coen van Kan, MD, of Our Lady’s Hospital in Amsterdam and colleagues at the University of Amsterdam reported in the September issue of the Journal of Thoracic and Cardiovascular Surgery (2016;152[3]:763-71).
“Our observations point to a hampered pulmonary vascular response and decreased ventilatory efficiency as underlying pathophysiological mechanisms to explain the exercise limitation observed in patients with CTED,” Dr. van Kan and colleagues wrote. “The clinically significant symptomatic improvement after surgery was shown to be related to significant improvements in both circulatory and ventilatory responses indicative for an improved right ventricle stroke volume during exercise and ventilatory efficiency.”
The researchers studied 14 patients with symptomatic CTED but with normal pulmonary pressures at rest. The patients underwent cardiopulmonary exercise testing (CPET) during right heart catheterization and then had noninvasive CPET 1 year later. During exercise the study subjects showed four features of abnormal pulmonary vascular responses:
• Steep mean pulmonary artery pressure/cardiac output (2.7 mm Hg/min per L).
• Low pulmonary vascular compliance (2.8 mL/mm Hg).
• Mean pulmonary artery pressure (mPAP)/cardiac output slope correlated with dead space ventilation (r = 0.586; P = .028).
• Ventilatory equivalents for carbon dioxide slope (r = 0.580; P = .030).
After screening for exercise-induced pulmonary hypertension, nine patients went on to have pulmonary endarterectomy (three patients had mPAP within normal limits during exercise and hence were not candidates, while two others declined surgery). All nine patients who had surgery survived, and a year afterward, their New York Heart Association functional class scores had improved from class II or II to class I in all patients. “Also, mean peak workload and mean oxygen consumption peak had increased, and the improvements observed tended to reach statistical significance,” Dr. van Kan and colleagues said.
After catheterization, improvement in exercise capacity was related to restoration of right ventricle stroke volume response, as measured by oxygen pulse improvement from 11.7 to 13.3 (P = .027) and heart rate response from 80.9 to 72 (P = .003); and a decrease in ventilatory equivalents for carbon dioxide slope from 38.2 to 32.8 (P = .014).
Dr. van Kan and coauthors had no financial relationships to disclose.
The pathophysiology of exercise intolerance in chronic thromboembolic disease (CTED) and mechanism of improvement after pulmonary endarterectomy have not been well understood, but researchers in the Netherlands have identified those key clinical characteristics of exercise intolerance as well as the mechanisms to response of treatment.
This is the first study to identify the pathophysiology of the exercise intolerance—abnormal pulmonary vascular response—and the underlying mechanism for the pulmonary improvement, Coen van Kan, MD, of Our Lady’s Hospital in Amsterdam and colleagues at the University of Amsterdam reported in the September issue of the Journal of Thoracic and Cardiovascular Surgery (2016;152[3]:763-71).
“Our observations point to a hampered pulmonary vascular response and decreased ventilatory efficiency as underlying pathophysiological mechanisms to explain the exercise limitation observed in patients with CTED,” Dr. van Kan and colleagues wrote. “The clinically significant symptomatic improvement after surgery was shown to be related to significant improvements in both circulatory and ventilatory responses indicative for an improved right ventricle stroke volume during exercise and ventilatory efficiency.”
The researchers studied 14 patients with symptomatic CTED but with normal pulmonary pressures at rest. The patients underwent cardiopulmonary exercise testing (CPET) during right heart catheterization and then had noninvasive CPET 1 year later. During exercise the study subjects showed four features of abnormal pulmonary vascular responses:
• Steep mean pulmonary artery pressure/cardiac output (2.7 mm Hg/min per L).
• Low pulmonary vascular compliance (2.8 mL/mm Hg).
• Mean pulmonary artery pressure (mPAP)/cardiac output slope correlated with dead space ventilation (r = 0.586; P = .028).
• Ventilatory equivalents for carbon dioxide slope (r = 0.580; P = .030).
After screening for exercise-induced pulmonary hypertension, nine patients went on to have pulmonary endarterectomy (three patients had mPAP within normal limits during exercise and hence were not candidates, while two others declined surgery). All nine patients who had surgery survived, and a year afterward, their New York Heart Association functional class scores had improved from class II or II to class I in all patients. “Also, mean peak workload and mean oxygen consumption peak had increased, and the improvements observed tended to reach statistical significance,” Dr. van Kan and colleagues said.
After catheterization, improvement in exercise capacity was related to restoration of right ventricle stroke volume response, as measured by oxygen pulse improvement from 11.7 to 13.3 (P = .027) and heart rate response from 80.9 to 72 (P = .003); and a decrease in ventilatory equivalents for carbon dioxide slope from 38.2 to 32.8 (P = .014).
Dr. van Kan and coauthors had no financial relationships to disclose.
FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: This study identifies key clinical features of the pathophysiology of exercise intolerance in chronic thromboembolic disease (CTED) as well and the mechanisms of responses to treatment that have not been well understood .
Major finding: Exercise intolerance may result from an abnormal pulmonary vascular response and decreased ventilatory efficiency, while pulmonary endarterectomy restores right ventricle stroke volume response and ventilatory efficiency.
Data source: Fourteen subjects with exercise-intolerant CTED but normal pulmonary pressure underwent cardiopulmonary exercise testing (CPET) during right heart catheterization and noninvasive CPET 1 year later.
Disclosures: Dr. van Kan and coauthors had no financial relationships to disclose.
Survival shorter in extended-criteria lung recipients
The availability of lungs for transplant has been severely limited by usable donors, but organs from so-called extended criteria donors – those aged 65 years or older, had a 20 pack-years or more smoking history or history of diabetes mellitus, or were black – were found to be associated with shorter survival than lungs from standard donor lungs, and recipients with more severe lung disease had the lowest survival rates from extended-criteria organs, an analysis of the national donor database found.
“Matching donor quality to recipient severity is critical to achieve optimal outcomes in lung transplantation,” Matthew J. Mulligan, MD, and his colleagues from the University of Maryland, Baltimore, said in the September issue of the Journal of Thoracic and Cardiovascular Surgery (2016;152:891-8). Dr. Mulligan previously presented the study results in April 2015 at the annual meeting of the American Association for Thoracic Surgery in Seattle.
The researchers analyzed 10,995 patients who received donor lungs between May 2005 and December 2012, 3,792 of whom received extended-criteria donor (ECD) organs. The study population was taken from the Organ Procurement and Transplantation Network/United Network for Organ Sharing database. Dr. Mulligan and his coauthors said this is the largest study examining ECD in lung transplants to date.
The goal of the study was to identify donor factors associated with reduced 1-year survival after transplantation, Dr. Mulligan and his colleagues said. “In the current literature, there is a paucity of data to guide the decision of matching donor quality to recipient severity,” the study authors said.
Recipients of extended-criteria lungs had a 41% increased risk of death, compared with recipients standard donor lungs, but individuals with more severe lung disease were at even greater risk with extended-criterial lungs, Dr. Mulligan and his colleagues said. Those who had a lung allocation score (LAS) less than 70 had a 1-year survival of 87% with standard donor lungs vs. 82% with extended-criteria lungs, while those who had a LAS of 70 or greater had survival rates of 80% and 72%, respectively.
Other donor factors that were inconsequential in recipient survival, Dr. Mulligan and his coauthors reported, included an abnormal chest x-ray, purulent secretions on bronchoscopy, blood type, mechanism of death (stroke, blunt trauma, gunshot, asphyxiation, and so on), or diagnosis of coronary artery disease and hypertension.
The researchers also did a Cox regression analysis, and found that recipients of extended-criteria lungs with a LAS greater than 70 had an 81% greater risk of death, compared with 37% for those with a LAS of 70 or greater who received standard-donor lungs, and 42% with a LAS of 70 or less and an extended-criteria donor lung.
These findings support the idea of not using ECD lungs in high-risk individuals with LAS greater than 70. “More important, ECD lungs were associated with the worst survival when transplanted into high-risk recipients,” Dr. Mulligan and his colleagues said.
The authors did acknowledge the inherent limitations of a retrospective analysis, but the large patient population is a redeeming factor of the study, Dr. Mulligan and his colleagues said. “Notwithstanding these limitations, the current study provides a rigorous analysis of a large number of lung transplants in the modern era, and the results reported will be useful to the lung transplant community,” the study authors said.
Dr. Mulligan and his coauthors had no relationships to disclose.
This study provides “greater clarity to the definition and significance of using lungs from an extended-criteria donor,” Benjamin Wei, MD, of the University of Alabama at Birmingham said in his invited commentary (J Thorac Cardiovasc Surg. 2016;152:899-900). “Now, we have more data about what constitutes an ECD for lung transplantation.”
The study also brought clarity on components of donor factors that do not affect survival – namely radiologic, bronchoscope, or laboratory criteria – Dr. Wei said. At the same time, the study raises questions about how transplant surgeons should use the findings. “Do we shy away from using donors with these high risk factors in low-risk recipients, high-risk recipients, neither, or both?” Dr. Wei asks. The study did not compare ECD lungs vs. no transplant, and becoming more selective in donors could cause more patients to die on the waiting list, he said.
A host of other questions also remain unanswered, Dr. Wei said, such as how a single standard-donor lung transplant compares with bilateral ECD transplants, or a single ECD lung vs. bilateral ECD lungs, and if use of ECD lungs by the criteria Dr. Mulligan and his coauthors outlined influences allograft patient survival.
“Of note, this study also did not include recipients receiving donor after cardiac death lungs or extracorporeal membrane oxygenation, both increasingly common situations,” he said. Nonetheless, the findings provide more information that transplant surgeons can base their decision-making on.
Dr. Wei had no financial relationships to disclose.
This study provides “greater clarity to the definition and significance of using lungs from an extended-criteria donor,” Benjamin Wei, MD, of the University of Alabama at Birmingham said in his invited commentary (J Thorac Cardiovasc Surg. 2016;152:899-900). “Now, we have more data about what constitutes an ECD for lung transplantation.”
The study also brought clarity on components of donor factors that do not affect survival – namely radiologic, bronchoscope, or laboratory criteria – Dr. Wei said. At the same time, the study raises questions about how transplant surgeons should use the findings. “Do we shy away from using donors with these high risk factors in low-risk recipients, high-risk recipients, neither, or both?” Dr. Wei asks. The study did not compare ECD lungs vs. no transplant, and becoming more selective in donors could cause more patients to die on the waiting list, he said.
A host of other questions also remain unanswered, Dr. Wei said, such as how a single standard-donor lung transplant compares with bilateral ECD transplants, or a single ECD lung vs. bilateral ECD lungs, and if use of ECD lungs by the criteria Dr. Mulligan and his coauthors outlined influences allograft patient survival.
“Of note, this study also did not include recipients receiving donor after cardiac death lungs or extracorporeal membrane oxygenation, both increasingly common situations,” he said. Nonetheless, the findings provide more information that transplant surgeons can base their decision-making on.
Dr. Wei had no financial relationships to disclose.
This study provides “greater clarity to the definition and significance of using lungs from an extended-criteria donor,” Benjamin Wei, MD, of the University of Alabama at Birmingham said in his invited commentary (J Thorac Cardiovasc Surg. 2016;152:899-900). “Now, we have more data about what constitutes an ECD for lung transplantation.”
The study also brought clarity on components of donor factors that do not affect survival – namely radiologic, bronchoscope, or laboratory criteria – Dr. Wei said. At the same time, the study raises questions about how transplant surgeons should use the findings. “Do we shy away from using donors with these high risk factors in low-risk recipients, high-risk recipients, neither, or both?” Dr. Wei asks. The study did not compare ECD lungs vs. no transplant, and becoming more selective in donors could cause more patients to die on the waiting list, he said.
A host of other questions also remain unanswered, Dr. Wei said, such as how a single standard-donor lung transplant compares with bilateral ECD transplants, or a single ECD lung vs. bilateral ECD lungs, and if use of ECD lungs by the criteria Dr. Mulligan and his coauthors outlined influences allograft patient survival.
“Of note, this study also did not include recipients receiving donor after cardiac death lungs or extracorporeal membrane oxygenation, both increasingly common situations,” he said. Nonetheless, the findings provide more information that transplant surgeons can base their decision-making on.
Dr. Wei had no financial relationships to disclose.
The availability of lungs for transplant has been severely limited by usable donors, but organs from so-called extended criteria donors – those aged 65 years or older, had a 20 pack-years or more smoking history or history of diabetes mellitus, or were black – were found to be associated with shorter survival than lungs from standard donor lungs, and recipients with more severe lung disease had the lowest survival rates from extended-criteria organs, an analysis of the national donor database found.
“Matching donor quality to recipient severity is critical to achieve optimal outcomes in lung transplantation,” Matthew J. Mulligan, MD, and his colleagues from the University of Maryland, Baltimore, said in the September issue of the Journal of Thoracic and Cardiovascular Surgery (2016;152:891-8). Dr. Mulligan previously presented the study results in April 2015 at the annual meeting of the American Association for Thoracic Surgery in Seattle.
The researchers analyzed 10,995 patients who received donor lungs between May 2005 and December 2012, 3,792 of whom received extended-criteria donor (ECD) organs. The study population was taken from the Organ Procurement and Transplantation Network/United Network for Organ Sharing database. Dr. Mulligan and his coauthors said this is the largest study examining ECD in lung transplants to date.
The goal of the study was to identify donor factors associated with reduced 1-year survival after transplantation, Dr. Mulligan and his colleagues said. “In the current literature, there is a paucity of data to guide the decision of matching donor quality to recipient severity,” the study authors said.
Recipients of extended-criteria lungs had a 41% increased risk of death, compared with recipients standard donor lungs, but individuals with more severe lung disease were at even greater risk with extended-criterial lungs, Dr. Mulligan and his colleagues said. Those who had a lung allocation score (LAS) less than 70 had a 1-year survival of 87% with standard donor lungs vs. 82% with extended-criteria lungs, while those who had a LAS of 70 or greater had survival rates of 80% and 72%, respectively.
Other donor factors that were inconsequential in recipient survival, Dr. Mulligan and his coauthors reported, included an abnormal chest x-ray, purulent secretions on bronchoscopy, blood type, mechanism of death (stroke, blunt trauma, gunshot, asphyxiation, and so on), or diagnosis of coronary artery disease and hypertension.
The researchers also did a Cox regression analysis, and found that recipients of extended-criteria lungs with a LAS greater than 70 had an 81% greater risk of death, compared with 37% for those with a LAS of 70 or greater who received standard-donor lungs, and 42% with a LAS of 70 or less and an extended-criteria donor lung.
These findings support the idea of not using ECD lungs in high-risk individuals with LAS greater than 70. “More important, ECD lungs were associated with the worst survival when transplanted into high-risk recipients,” Dr. Mulligan and his colleagues said.
The authors did acknowledge the inherent limitations of a retrospective analysis, but the large patient population is a redeeming factor of the study, Dr. Mulligan and his colleagues said. “Notwithstanding these limitations, the current study provides a rigorous analysis of a large number of lung transplants in the modern era, and the results reported will be useful to the lung transplant community,” the study authors said.
Dr. Mulligan and his coauthors had no relationships to disclose.
The availability of lungs for transplant has been severely limited by usable donors, but organs from so-called extended criteria donors – those aged 65 years or older, had a 20 pack-years or more smoking history or history of diabetes mellitus, or were black – were found to be associated with shorter survival than lungs from standard donor lungs, and recipients with more severe lung disease had the lowest survival rates from extended-criteria organs, an analysis of the national donor database found.
“Matching donor quality to recipient severity is critical to achieve optimal outcomes in lung transplantation,” Matthew J. Mulligan, MD, and his colleagues from the University of Maryland, Baltimore, said in the September issue of the Journal of Thoracic and Cardiovascular Surgery (2016;152:891-8). Dr. Mulligan previously presented the study results in April 2015 at the annual meeting of the American Association for Thoracic Surgery in Seattle.
The researchers analyzed 10,995 patients who received donor lungs between May 2005 and December 2012, 3,792 of whom received extended-criteria donor (ECD) organs. The study population was taken from the Organ Procurement and Transplantation Network/United Network for Organ Sharing database. Dr. Mulligan and his coauthors said this is the largest study examining ECD in lung transplants to date.
The goal of the study was to identify donor factors associated with reduced 1-year survival after transplantation, Dr. Mulligan and his colleagues said. “In the current literature, there is a paucity of data to guide the decision of matching donor quality to recipient severity,” the study authors said.
Recipients of extended-criteria lungs had a 41% increased risk of death, compared with recipients standard donor lungs, but individuals with more severe lung disease were at even greater risk with extended-criterial lungs, Dr. Mulligan and his colleagues said. Those who had a lung allocation score (LAS) less than 70 had a 1-year survival of 87% with standard donor lungs vs. 82% with extended-criteria lungs, while those who had a LAS of 70 or greater had survival rates of 80% and 72%, respectively.
Other donor factors that were inconsequential in recipient survival, Dr. Mulligan and his coauthors reported, included an abnormal chest x-ray, purulent secretions on bronchoscopy, blood type, mechanism of death (stroke, blunt trauma, gunshot, asphyxiation, and so on), or diagnosis of coronary artery disease and hypertension.
The researchers also did a Cox regression analysis, and found that recipients of extended-criteria lungs with a LAS greater than 70 had an 81% greater risk of death, compared with 37% for those with a LAS of 70 or greater who received standard-donor lungs, and 42% with a LAS of 70 or less and an extended-criteria donor lung.
These findings support the idea of not using ECD lungs in high-risk individuals with LAS greater than 70. “More important, ECD lungs were associated with the worst survival when transplanted into high-risk recipients,” Dr. Mulligan and his colleagues said.
The authors did acknowledge the inherent limitations of a retrospective analysis, but the large patient population is a redeeming factor of the study, Dr. Mulligan and his colleagues said. “Notwithstanding these limitations, the current study provides a rigorous analysis of a large number of lung transplants in the modern era, and the results reported will be useful to the lung transplant community,” the study authors said.
Dr. Mulligan and his coauthors had no relationships to disclose.
FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: Lung transplant recipients who received extended-criteria donor (ECD) lungs have lower rates of 1-year survival than recipients of standard donor lungs.
Major finding: Recipients of ECD lungs had a 41% higher risk of death than recipients of standard lungs, and those who had more severe lung disease had lower rates of 1-year survival after receiving ECD lungs, compared with standard donor lungs.
Data source: Retrospective analysis of 10,995 lung recipients, from the Organ Procurement and Transplantation Network/United Network for Organ Sharing database, 3,792 of whom who received extended-criteria donor organs over 7.5 years.
Disclosures: Dr. Mulligan and his coauthors had no financial relationships to disclose.
Can TEE find septal defects in conotruncal repair?
Intramural ventricular septal defects (VSD), residual defects that can occur after repair of conotruncal defects in newborns, increase the risk of complications and death if they’re not detected and closed during the index operation. While various methods have been tried to find these defects during surgery, researchers from Children’s Hospital of Philadelphia (CHOP) reported that the use of transesophageal echocardiography (TEE) has a good chance of finding VSDs and giving cardiac surgeons the opportunity to correct these residual defects.
“TEE has modest sensitivity but high specificity for identifying intramural VSDs and can identify most defects requiring reinterventions,” Jyoti Patel, MD, and her coauthors reported in a study published in the September issue of the Journal of Thoracic and Cardiovascular Surgery (2016;152:688-95).
Previous studies have shown that intraoperative TEE is safe for evaluating operations in congenital heart disease, but this is the first study to evaluate the modality for detecting intramural VSDs, Dr. Patel and her colleagues said.
Dr. Patel and her coinvestigators analyzed results of TEE and postoperative transthoracic echocardiography (TTE) in patients who had biventricular repair of conotruncal anomalies at CHOP from January 2006 through June 2013. Intramural VSDs occurred in 34 of 337 patients who met the inclusion criteria out of a total population of 903. Actually, 462 patients had biventricular repairs of conotruncal defects involving baffle closure of a VSD, but 125 were excluded for various reasons, including 105 for inadequate intraoperative TEE.
TTE identified a total of 177 residual VSDs, 34 of which were intramural in nature. Among the evaluated procedures, both TEE at the end of the index operation and TTE detected VSD in 19 patients; TTE alone found VSD in 15. “Sensitivity was 56% and specificity was 100% for TEE to identify intramural VSDs,” Dr. Patel and her colleagues said.
What’s more, both TTE and TEE combined identified peripatch VSDs in 90 patients, while TTE only in 53 and TEE only in 15, “yielding a sensitivity of 63% and specificity of 92%,” Dr. Patel and her colleagues said.
Of the VSDs that required catheterization or reintervention during surgery, intraoperative TEE detected six of seven intramural VSDs and all five peripatch VSDs, the study found.
“In this study, TEE identified most intramural VSDs and all peripatch VSDs that required subsequent reintervention,” Dr. Patel and her colleagues said.
“This finding underscores the importance of adequate imaging of the superior aspect of the VSD patch during intraoperative TEE for conotruncal anomalies, given that many intramural defects may be repaired during the initial operation.”
Coauthor Andrew Glatz, MD, disclosed receiving consulting fees from Bristol-Myers Squibb, and coauthor Chitra Ravishankar, MD, disclosed lecture fees from Danone Medical. Dr. Patel and the remaining coauthors had no financial relationships to disclose.
Because of the clinical importance of intramural VSDs, cardiac surgeons need to be highly suspicious in any operation to repair conotruncal defects where the VSD margins are close to the trabeculae, Edward Buratto, MBBS, Philip Naimo, MD, and Igor Konstantinov, MD, PhD, of Royal Children’s Hospital at the University of Melbourne said in their invited commentary (J Thorac Cardiovasc Surg. 2016;152:696-7). “The best way to resolve the problem would be to prevent it,” they said.
While intraoperative TEE can detect VSDs preemptively, the imaging technique is “not without its flaws,” the commentators said, as evidenced by the 105 subjects the CHOP study excluded because of inadequate TEE imaging. Those excluded cases comprised patients aged 30 days and younger with lower body weight and higher early death rates. “It is these patients who would benefit most from intraoperative identification of intramural VSD,” the commentators said.
They also noted that TEE in detecting intramural and peripatch VSD in children aged 30 days and older “was not perfect either,” with sensitivities of 56% and 63%, respectively. In the CHOP study, TEE was more likely to detect intramural VSD in patients older than 30 days with higher body weight, Dr. Buratto and his colleagues said.
The favored approach at Royal Children’s Hospital in Melbourne is routine epicardial echocardiograms in conotruncal repair. This imaging technique provides “superb imaging quality,” they said. “This is of particular importance in small children.” They advocate closing a significant VSD once it’s identified.
“After all, failure to close intramural VSD occurs when surgeons do not realize how close they were to success when they gave up,” the commentators said. Precise echocardiographic guidance would “dramatically facilitate” that strategy.
Dr. Buratto, Dr. Naimo, and Dr. Konstantinov had no financial relationships to disclose.
Because of the clinical importance of intramural VSDs, cardiac surgeons need to be highly suspicious in any operation to repair conotruncal defects where the VSD margins are close to the trabeculae, Edward Buratto, MBBS, Philip Naimo, MD, and Igor Konstantinov, MD, PhD, of Royal Children’s Hospital at the University of Melbourne said in their invited commentary (J Thorac Cardiovasc Surg. 2016;152:696-7). “The best way to resolve the problem would be to prevent it,” they said.
While intraoperative TEE can detect VSDs preemptively, the imaging technique is “not without its flaws,” the commentators said, as evidenced by the 105 subjects the CHOP study excluded because of inadequate TEE imaging. Those excluded cases comprised patients aged 30 days and younger with lower body weight and higher early death rates. “It is these patients who would benefit most from intraoperative identification of intramural VSD,” the commentators said.
They also noted that TEE in detecting intramural and peripatch VSD in children aged 30 days and older “was not perfect either,” with sensitivities of 56% and 63%, respectively. In the CHOP study, TEE was more likely to detect intramural VSD in patients older than 30 days with higher body weight, Dr. Buratto and his colleagues said.
The favored approach at Royal Children’s Hospital in Melbourne is routine epicardial echocardiograms in conotruncal repair. This imaging technique provides “superb imaging quality,” they said. “This is of particular importance in small children.” They advocate closing a significant VSD once it’s identified.
“After all, failure to close intramural VSD occurs when surgeons do not realize how close they were to success when they gave up,” the commentators said. Precise echocardiographic guidance would “dramatically facilitate” that strategy.
Dr. Buratto, Dr. Naimo, and Dr. Konstantinov had no financial relationships to disclose.
Because of the clinical importance of intramural VSDs, cardiac surgeons need to be highly suspicious in any operation to repair conotruncal defects where the VSD margins are close to the trabeculae, Edward Buratto, MBBS, Philip Naimo, MD, and Igor Konstantinov, MD, PhD, of Royal Children’s Hospital at the University of Melbourne said in their invited commentary (J Thorac Cardiovasc Surg. 2016;152:696-7). “The best way to resolve the problem would be to prevent it,” they said.
While intraoperative TEE can detect VSDs preemptively, the imaging technique is “not without its flaws,” the commentators said, as evidenced by the 105 subjects the CHOP study excluded because of inadequate TEE imaging. Those excluded cases comprised patients aged 30 days and younger with lower body weight and higher early death rates. “It is these patients who would benefit most from intraoperative identification of intramural VSD,” the commentators said.
They also noted that TEE in detecting intramural and peripatch VSD in children aged 30 days and older “was not perfect either,” with sensitivities of 56% and 63%, respectively. In the CHOP study, TEE was more likely to detect intramural VSD in patients older than 30 days with higher body weight, Dr. Buratto and his colleagues said.
The favored approach at Royal Children’s Hospital in Melbourne is routine epicardial echocardiograms in conotruncal repair. This imaging technique provides “superb imaging quality,” they said. “This is of particular importance in small children.” They advocate closing a significant VSD once it’s identified.
“After all, failure to close intramural VSD occurs when surgeons do not realize how close they were to success when they gave up,” the commentators said. Precise echocardiographic guidance would “dramatically facilitate” that strategy.
Dr. Buratto, Dr. Naimo, and Dr. Konstantinov had no financial relationships to disclose.
Intramural ventricular septal defects (VSD), residual defects that can occur after repair of conotruncal defects in newborns, increase the risk of complications and death if they’re not detected and closed during the index operation. While various methods have been tried to find these defects during surgery, researchers from Children’s Hospital of Philadelphia (CHOP) reported that the use of transesophageal echocardiography (TEE) has a good chance of finding VSDs and giving cardiac surgeons the opportunity to correct these residual defects.
“TEE has modest sensitivity but high specificity for identifying intramural VSDs and can identify most defects requiring reinterventions,” Jyoti Patel, MD, and her coauthors reported in a study published in the September issue of the Journal of Thoracic and Cardiovascular Surgery (2016;152:688-95).
Previous studies have shown that intraoperative TEE is safe for evaluating operations in congenital heart disease, but this is the first study to evaluate the modality for detecting intramural VSDs, Dr. Patel and her colleagues said.
Dr. Patel and her coinvestigators analyzed results of TEE and postoperative transthoracic echocardiography (TTE) in patients who had biventricular repair of conotruncal anomalies at CHOP from January 2006 through June 2013. Intramural VSDs occurred in 34 of 337 patients who met the inclusion criteria out of a total population of 903. Actually, 462 patients had biventricular repairs of conotruncal defects involving baffle closure of a VSD, but 125 were excluded for various reasons, including 105 for inadequate intraoperative TEE.
TTE identified a total of 177 residual VSDs, 34 of which were intramural in nature. Among the evaluated procedures, both TEE at the end of the index operation and TTE detected VSD in 19 patients; TTE alone found VSD in 15. “Sensitivity was 56% and specificity was 100% for TEE to identify intramural VSDs,” Dr. Patel and her colleagues said.
What’s more, both TTE and TEE combined identified peripatch VSDs in 90 patients, while TTE only in 53 and TEE only in 15, “yielding a sensitivity of 63% and specificity of 92%,” Dr. Patel and her colleagues said.
Of the VSDs that required catheterization or reintervention during surgery, intraoperative TEE detected six of seven intramural VSDs and all five peripatch VSDs, the study found.
“In this study, TEE identified most intramural VSDs and all peripatch VSDs that required subsequent reintervention,” Dr. Patel and her colleagues said.
“This finding underscores the importance of adequate imaging of the superior aspect of the VSD patch during intraoperative TEE for conotruncal anomalies, given that many intramural defects may be repaired during the initial operation.”
Coauthor Andrew Glatz, MD, disclosed receiving consulting fees from Bristol-Myers Squibb, and coauthor Chitra Ravishankar, MD, disclosed lecture fees from Danone Medical. Dr. Patel and the remaining coauthors had no financial relationships to disclose.
Intramural ventricular septal defects (VSD), residual defects that can occur after repair of conotruncal defects in newborns, increase the risk of complications and death if they’re not detected and closed during the index operation. While various methods have been tried to find these defects during surgery, researchers from Children’s Hospital of Philadelphia (CHOP) reported that the use of transesophageal echocardiography (TEE) has a good chance of finding VSDs and giving cardiac surgeons the opportunity to correct these residual defects.
“TEE has modest sensitivity but high specificity for identifying intramural VSDs and can identify most defects requiring reinterventions,” Jyoti Patel, MD, and her coauthors reported in a study published in the September issue of the Journal of Thoracic and Cardiovascular Surgery (2016;152:688-95).
Previous studies have shown that intraoperative TEE is safe for evaluating operations in congenital heart disease, but this is the first study to evaluate the modality for detecting intramural VSDs, Dr. Patel and her colleagues said.
Dr. Patel and her coinvestigators analyzed results of TEE and postoperative transthoracic echocardiography (TTE) in patients who had biventricular repair of conotruncal anomalies at CHOP from January 2006 through June 2013. Intramural VSDs occurred in 34 of 337 patients who met the inclusion criteria out of a total population of 903. Actually, 462 patients had biventricular repairs of conotruncal defects involving baffle closure of a VSD, but 125 were excluded for various reasons, including 105 for inadequate intraoperative TEE.
TTE identified a total of 177 residual VSDs, 34 of which were intramural in nature. Among the evaluated procedures, both TEE at the end of the index operation and TTE detected VSD in 19 patients; TTE alone found VSD in 15. “Sensitivity was 56% and specificity was 100% for TEE to identify intramural VSDs,” Dr. Patel and her colleagues said.
What’s more, both TTE and TEE combined identified peripatch VSDs in 90 patients, while TTE only in 53 and TEE only in 15, “yielding a sensitivity of 63% and specificity of 92%,” Dr. Patel and her colleagues said.
Of the VSDs that required catheterization or reintervention during surgery, intraoperative TEE detected six of seven intramural VSDs and all five peripatch VSDs, the study found.
“In this study, TEE identified most intramural VSDs and all peripatch VSDs that required subsequent reintervention,” Dr. Patel and her colleagues said.
“This finding underscores the importance of adequate imaging of the superior aspect of the VSD patch during intraoperative TEE for conotruncal anomalies, given that many intramural defects may be repaired during the initial operation.”
Coauthor Andrew Glatz, MD, disclosed receiving consulting fees from Bristol-Myers Squibb, and coauthor Chitra Ravishankar, MD, disclosed lecture fees from Danone Medical. Dr. Patel and the remaining coauthors had no financial relationships to disclose.
FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: Intraoperative transesophageal echocardiography has modest sensitivity but high specificity for detecting ventricular septal defects after repair of conotruncal anomalies.
Major finding: TEE is useful for identifying most VSDs during the index operation, providing the opportunity to repair the defects during the index operation.
Data source: A single-institution database of 337 patients who had operations to repair conotruncal anomalies between January 2006 and June 2013.
Disclosures: Coauthor Andrew Glatz, MD, disclosed receiving consulting fees from Bristol-Myers Squibb, and coauthor Chitra Ravishankar, MD, disclosed lecture fees from Danone Medical. Dr. Patel and the remaining coauthors had no financial relationships to disclose.
Transcatheter mitral valve therapy at ‘event horizon’
As investigational transcatheter mitral valve therapies continue to explode onto the scene, cardiac surgeons must act now to seize and assert their place in the multidisciplinary team with interventional, imaging, and heart failure colleagues to deliver these treatments to people with complex mitral valve regurgitation, an expert opinion report in the August issue of the Journal of Thoracic and Cardiovascular Surgery states (J Thorac Cardiovasc Surg. 2016;152:330-6).
“There is a growing population of patients with primary and secondary mitral regurgitation underserved by surgical therapy because of comorbid risk,” Vinay Badhwar, MD, of West Virginia University and his colleagues said. “This has led to a tremendous activity of device development.”
With more than 25 different transcatheter mitral valve devices in development (MitraClip, Abbott Vascular, is the only FDA-approved transcatheter for primary mitral regurgitation [MR]), cardiac surgeons will soon have the tools to offer transcatheter mitral valve repair (TMVr) and transcatheter mitral valve replacement (TMVR) to more complex patients who have MR along with other health problems. Today about half of those patients do not get surgery because they are too frail, Dr. Badhwar and his colleagues said.
The authors used the astrophysical phrase “event horizon” to define the current state of transcatheter mitral valve therapies – “a point of no return.” They expect surgery to remain the treatment of choice for MR for the next 10 years. “However, as our patient cohorts become increasingly more complex and transcatheter mitral therapies more facile, the day when this will become a daily clinical reality will soon be upon us,” Dr. Badhwar and his colleagues said.
The multidisciplinary team approach will be integral in achieving the full potential of transcatheter mitral valve replacement or repair, Dr. Badhwar and his coauthors said. While surgery is the most effective treatment for primary MR, cardiac surgeons are challenged to introduce transcatheter treatments in patients who have other health problems. “The best way to adjudicate innovative surgical and interventional mitral therapies is through a robust collaboration within a well-functioning heart team that includes not only a cardiac surgeon and interventional cardiologist but also an imaging specialist,” the authors said.
The time to reach out to those other specialties is now, before those investigational devices start emerging from the development pipeline, Dr. Badhwar and his colleagues said. “This will soon enable the team-based mitral specialist to be facile in safely transitioning patients from open mitral surgery to TMVr or TMVR as most appropriate for durable long-term outcomes.”
Dr. Badhwar disclosed he is an uncompensated member of the Abbott Vascular advisory board. Coauthor Vinod Thourani, MD, disclosed relationships with Edwards Lifesciences, Medtronic Cardiovascular, Abbott Vascular, St. Jude Medical, Mitralign, and AtriCure. Coauthor Michael Mack, MD, serves on the Edwards Lifesciences steering committee Partner Trial and is an uncompensated co-principal investigator of the Abbott Vascular Clinical Outcomes Assessment of the MitraClip Percutaneous Therapy Trial.
Channeling Bob Dylan’s “The Times They Are A-Changin’” in his invited commentary, W. Randolph Chitwood Jr., MD, of East Carolina University in Greenville, N.C., called Dr. Badhwar’s expert opinion “the clarion call for cardiac surgeons to become engaged in this rapidly evolving parade.”
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Dr. W. Randolph Chitwood Jr. |
The evidence supporting the safety and efficacy of transcatheter aortic valve replacement (TAVR) is already strong, Dr. Chitwood noted. “It seems reasonable to suspect that the evolving pathway for the development of transcatheter mitral valve replacement (TMVR) could recapitulate the success of TAVR, with each generation having improved results,” he said (J Thorac Cardiovasc Surg. 2016;152:336-7).
Cardiac surgeons need to develop alternate access platforms and acquire the skills to use the new generation of transcatheter mitral devices, Dr. Chitwood said. The expert opinion “should encourage cardiac surgeons to become members of a heart team,” he said. “Guidewire skills are at the pinnacle of necessity to remain a player in this new world.”
Dr. Chitwood’s advice to colleagues: “Then you better start swimming or you’ll sink like a stone, For the times they are a-changin’.”
Dr. Chitwood disclosed he is a consultant to Direct Flow Medical and co-principal investigator for the Edwards Lifesciences Transform Trial.
Channeling Bob Dylan’s “The Times They Are A-Changin’” in his invited commentary, W. Randolph Chitwood Jr., MD, of East Carolina University in Greenville, N.C., called Dr. Badhwar’s expert opinion “the clarion call for cardiac surgeons to become engaged in this rapidly evolving parade.”
|
Dr. W. Randolph Chitwood Jr. |
The evidence supporting the safety and efficacy of transcatheter aortic valve replacement (TAVR) is already strong, Dr. Chitwood noted. “It seems reasonable to suspect that the evolving pathway for the development of transcatheter mitral valve replacement (TMVR) could recapitulate the success of TAVR, with each generation having improved results,” he said (J Thorac Cardiovasc Surg. 2016;152:336-7).
Cardiac surgeons need to develop alternate access platforms and acquire the skills to use the new generation of transcatheter mitral devices, Dr. Chitwood said. The expert opinion “should encourage cardiac surgeons to become members of a heart team,” he said. “Guidewire skills are at the pinnacle of necessity to remain a player in this new world.”
Dr. Chitwood’s advice to colleagues: “Then you better start swimming or you’ll sink like a stone, For the times they are a-changin’.”
Dr. Chitwood disclosed he is a consultant to Direct Flow Medical and co-principal investigator for the Edwards Lifesciences Transform Trial.
Channeling Bob Dylan’s “The Times They Are A-Changin’” in his invited commentary, W. Randolph Chitwood Jr., MD, of East Carolina University in Greenville, N.C., called Dr. Badhwar’s expert opinion “the clarion call for cardiac surgeons to become engaged in this rapidly evolving parade.”
|
Dr. W. Randolph Chitwood Jr. |
The evidence supporting the safety and efficacy of transcatheter aortic valve replacement (TAVR) is already strong, Dr. Chitwood noted. “It seems reasonable to suspect that the evolving pathway for the development of transcatheter mitral valve replacement (TMVR) could recapitulate the success of TAVR, with each generation having improved results,” he said (J Thorac Cardiovasc Surg. 2016;152:336-7).
Cardiac surgeons need to develop alternate access platforms and acquire the skills to use the new generation of transcatheter mitral devices, Dr. Chitwood said. The expert opinion “should encourage cardiac surgeons to become members of a heart team,” he said. “Guidewire skills are at the pinnacle of necessity to remain a player in this new world.”
Dr. Chitwood’s advice to colleagues: “Then you better start swimming or you’ll sink like a stone, For the times they are a-changin’.”
Dr. Chitwood disclosed he is a consultant to Direct Flow Medical and co-principal investigator for the Edwards Lifesciences Transform Trial.
As investigational transcatheter mitral valve therapies continue to explode onto the scene, cardiac surgeons must act now to seize and assert their place in the multidisciplinary team with interventional, imaging, and heart failure colleagues to deliver these treatments to people with complex mitral valve regurgitation, an expert opinion report in the August issue of the Journal of Thoracic and Cardiovascular Surgery states (J Thorac Cardiovasc Surg. 2016;152:330-6).
“There is a growing population of patients with primary and secondary mitral regurgitation underserved by surgical therapy because of comorbid risk,” Vinay Badhwar, MD, of West Virginia University and his colleagues said. “This has led to a tremendous activity of device development.”
With more than 25 different transcatheter mitral valve devices in development (MitraClip, Abbott Vascular, is the only FDA-approved transcatheter for primary mitral regurgitation [MR]), cardiac surgeons will soon have the tools to offer transcatheter mitral valve repair (TMVr) and transcatheter mitral valve replacement (TMVR) to more complex patients who have MR along with other health problems. Today about half of those patients do not get surgery because they are too frail, Dr. Badhwar and his colleagues said.
The authors used the astrophysical phrase “event horizon” to define the current state of transcatheter mitral valve therapies – “a point of no return.” They expect surgery to remain the treatment of choice for MR for the next 10 years. “However, as our patient cohorts become increasingly more complex and transcatheter mitral therapies more facile, the day when this will become a daily clinical reality will soon be upon us,” Dr. Badhwar and his colleagues said.
The multidisciplinary team approach will be integral in achieving the full potential of transcatheter mitral valve replacement or repair, Dr. Badhwar and his coauthors said. While surgery is the most effective treatment for primary MR, cardiac surgeons are challenged to introduce transcatheter treatments in patients who have other health problems. “The best way to adjudicate innovative surgical and interventional mitral therapies is through a robust collaboration within a well-functioning heart team that includes not only a cardiac surgeon and interventional cardiologist but also an imaging specialist,” the authors said.
The time to reach out to those other specialties is now, before those investigational devices start emerging from the development pipeline, Dr. Badhwar and his colleagues said. “This will soon enable the team-based mitral specialist to be facile in safely transitioning patients from open mitral surgery to TMVr or TMVR as most appropriate for durable long-term outcomes.”
Dr. Badhwar disclosed he is an uncompensated member of the Abbott Vascular advisory board. Coauthor Vinod Thourani, MD, disclosed relationships with Edwards Lifesciences, Medtronic Cardiovascular, Abbott Vascular, St. Jude Medical, Mitralign, and AtriCure. Coauthor Michael Mack, MD, serves on the Edwards Lifesciences steering committee Partner Trial and is an uncompensated co-principal investigator of the Abbott Vascular Clinical Outcomes Assessment of the MitraClip Percutaneous Therapy Trial.
As investigational transcatheter mitral valve therapies continue to explode onto the scene, cardiac surgeons must act now to seize and assert their place in the multidisciplinary team with interventional, imaging, and heart failure colleagues to deliver these treatments to people with complex mitral valve regurgitation, an expert opinion report in the August issue of the Journal of Thoracic and Cardiovascular Surgery states (J Thorac Cardiovasc Surg. 2016;152:330-6).
“There is a growing population of patients with primary and secondary mitral regurgitation underserved by surgical therapy because of comorbid risk,” Vinay Badhwar, MD, of West Virginia University and his colleagues said. “This has led to a tremendous activity of device development.”
With more than 25 different transcatheter mitral valve devices in development (MitraClip, Abbott Vascular, is the only FDA-approved transcatheter for primary mitral regurgitation [MR]), cardiac surgeons will soon have the tools to offer transcatheter mitral valve repair (TMVr) and transcatheter mitral valve replacement (TMVR) to more complex patients who have MR along with other health problems. Today about half of those patients do not get surgery because they are too frail, Dr. Badhwar and his colleagues said.
The authors used the astrophysical phrase “event horizon” to define the current state of transcatheter mitral valve therapies – “a point of no return.” They expect surgery to remain the treatment of choice for MR for the next 10 years. “However, as our patient cohorts become increasingly more complex and transcatheter mitral therapies more facile, the day when this will become a daily clinical reality will soon be upon us,” Dr. Badhwar and his colleagues said.
The multidisciplinary team approach will be integral in achieving the full potential of transcatheter mitral valve replacement or repair, Dr. Badhwar and his coauthors said. While surgery is the most effective treatment for primary MR, cardiac surgeons are challenged to introduce transcatheter treatments in patients who have other health problems. “The best way to adjudicate innovative surgical and interventional mitral therapies is through a robust collaboration within a well-functioning heart team that includes not only a cardiac surgeon and interventional cardiologist but also an imaging specialist,” the authors said.
The time to reach out to those other specialties is now, before those investigational devices start emerging from the development pipeline, Dr. Badhwar and his colleagues said. “This will soon enable the team-based mitral specialist to be facile in safely transitioning patients from open mitral surgery to TMVr or TMVR as most appropriate for durable long-term outcomes.”
Dr. Badhwar disclosed he is an uncompensated member of the Abbott Vascular advisory board. Coauthor Vinod Thourani, MD, disclosed relationships with Edwards Lifesciences, Medtronic Cardiovascular, Abbott Vascular, St. Jude Medical, Mitralign, and AtriCure. Coauthor Michael Mack, MD, serves on the Edwards Lifesciences steering committee Partner Trial and is an uncompensated co-principal investigator of the Abbott Vascular Clinical Outcomes Assessment of the MitraClip Percutaneous Therapy Trial.
FROM THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY
Key clinical point: Transcatheter mitral valve repair and replacement technology has reached a critical point that requires cardiac surgeons to assume their place in a multidisciplinary team.
Major finding: One transcatheter device is commercially available in the United States and more than 25 companies have devices in development.
Data source: Review of 22 published reports on transcatheter mitral valve technology.
Disclosures: Dr. Badhwar disclosed he is an uncompensated member of the Abbott Vascular advisory board. Coauthor Vinod Thourani, MD, disclosed relationships with Edwards Lifesciences, Medtronic Cardiovascular, Abbott Vascular, St. Jude Medical, Mitralign and AtriCure. Coauthor Michael Mack, MD, serves on the Edwards Lifesciences steering committee Partner Trial, and is an uncompensated co-principal investigator of the Abbott Vascular Clinical Outcomes Assessment of the MitraClip Percutaneous Therapy Trial.
VIDEO: When is it time to jump into MACRA with both feet?
LAS VEGAS – Change in federal reimbursement for physicians is coming. Though the change is inevitable, physicians still have to weigh choices about when they might want to jump in with both feet, since entry into the full incentive payment system will be optional – for a time.
The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) is “basically a reorganization of all of these disparate reward and penalty systems” that have existed within the federal health care reimbursement landscape, said Joseph S. Eastern, MD. “The idea was to collect them all within one system.”
The new system is called the Medicare Incentive Payment System, or MIPS. Physicians are already familiar with many MIPS components, including meaningful use of the electronic health record, “which everybody thought was going away, but it isn’t,” said Dr. Eastern, a dermatologist in private practice in Belleville, N.J., who’s affiliated with Seton Hall University, South Orange, N.J. Also included are the Physician Quality Reimbursement System (PQRS) and the value-based modifier system.
MIPS is designed so that “you’ll either get a reward or a penalty depending on how well you do, compared with other physicians,” said Dr. Eastern, speaking at the annual Perspectives in Rheumatic Diseases held by Global Academy for Medical Education.
The alternative, he said, is to opt for one of the Alternative Payment Models, or APMs. However, details about APMs are “really up in the air, because a lot of them have either not been doing very well, or have not been very well defined,” so that physicians often don’t currently have enough data to make an informed choice. He expects the APM landscape to sort out over the next year or two.
Opting not to comply and take the 1%-3% cut in Medicare reimbursement associated with noncompliance might make sense for just a few physicians, though it might seem tempting, Dr. Eastern said in a video interview. Since the penalties will escalate significantly over the next few years, he feels that only physicians who are considering retiring soon or selling their practices should consider opting out.
Global Academy for Medical Education and this news organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @karioakes
LAS VEGAS – Change in federal reimbursement for physicians is coming. Though the change is inevitable, physicians still have to weigh choices about when they might want to jump in with both feet, since entry into the full incentive payment system will be optional – for a time.
The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) is “basically a reorganization of all of these disparate reward and penalty systems” that have existed within the federal health care reimbursement landscape, said Joseph S. Eastern, MD. “The idea was to collect them all within one system.”
The new system is called the Medicare Incentive Payment System, or MIPS. Physicians are already familiar with many MIPS components, including meaningful use of the electronic health record, “which everybody thought was going away, but it isn’t,” said Dr. Eastern, a dermatologist in private practice in Belleville, N.J., who’s affiliated with Seton Hall University, South Orange, N.J. Also included are the Physician Quality Reimbursement System (PQRS) and the value-based modifier system.
MIPS is designed so that “you’ll either get a reward or a penalty depending on how well you do, compared with other physicians,” said Dr. Eastern, speaking at the annual Perspectives in Rheumatic Diseases held by Global Academy for Medical Education.
The alternative, he said, is to opt for one of the Alternative Payment Models, or APMs. However, details about APMs are “really up in the air, because a lot of them have either not been doing very well, or have not been very well defined,” so that physicians often don’t currently have enough data to make an informed choice. He expects the APM landscape to sort out over the next year or two.
Opting not to comply and take the 1%-3% cut in Medicare reimbursement associated with noncompliance might make sense for just a few physicians, though it might seem tempting, Dr. Eastern said in a video interview. Since the penalties will escalate significantly over the next few years, he feels that only physicians who are considering retiring soon or selling their practices should consider opting out.
Global Academy for Medical Education and this news organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @karioakes
LAS VEGAS – Change in federal reimbursement for physicians is coming. Though the change is inevitable, physicians still have to weigh choices about when they might want to jump in with both feet, since entry into the full incentive payment system will be optional – for a time.
The Medicare Access and CHIP Reauthorization Act of 2015 (MACRA) is “basically a reorganization of all of these disparate reward and penalty systems” that have existed within the federal health care reimbursement landscape, said Joseph S. Eastern, MD. “The idea was to collect them all within one system.”
The new system is called the Medicare Incentive Payment System, or MIPS. Physicians are already familiar with many MIPS components, including meaningful use of the electronic health record, “which everybody thought was going away, but it isn’t,” said Dr. Eastern, a dermatologist in private practice in Belleville, N.J., who’s affiliated with Seton Hall University, South Orange, N.J. Also included are the Physician Quality Reimbursement System (PQRS) and the value-based modifier system.
MIPS is designed so that “you’ll either get a reward or a penalty depending on how well you do, compared with other physicians,” said Dr. Eastern, speaking at the annual Perspectives in Rheumatic Diseases held by Global Academy for Medical Education.
The alternative, he said, is to opt for one of the Alternative Payment Models, or APMs. However, details about APMs are “really up in the air, because a lot of them have either not been doing very well, or have not been very well defined,” so that physicians often don’t currently have enough data to make an informed choice. He expects the APM landscape to sort out over the next year or two.
Opting not to comply and take the 1%-3% cut in Medicare reimbursement associated with noncompliance might make sense for just a few physicians, though it might seem tempting, Dr. Eastern said in a video interview. Since the penalties will escalate significantly over the next few years, he feels that only physicians who are considering retiring soon or selling their practices should consider opting out.
Global Academy for Medical Education and this news organization are owned by the same parent company.
The video associated with this article is no longer available on this site. Please view all of our videos on the MDedge YouTube channel
On Twitter @karioakes
EXPERT ANALYSIS FROM THE ANNUAL PERSPECTIVES IN RHEUMATIC DISEASES
CABG reduces cardiovascular mortality in ischemic heart failure regardless of age
ROME – Coronary artery bypass surgery reduces cardiovascular mortality in heart failure patients with ischemic cardiomyopathy to a consistent extent regardless of age at the time of surgery, according to a secondary analysis from the landmark STICH trial, Eric J. Velazquez, MD, reported at the annual congress of the European Society of Cardiology.
“Cardiologists and cardiac surgeons can confidently offer patients CABG in addition to optimal medical therapy with the knowledge that cardiovascular mortality is reduced by CABG to a similar extent across all age groups in this trial through 10 years of follow-up,” said Dr. Velazquez, professor of medicine at Duke University in Durham, N.C.
However, that’s only part of the story. Cardiovascular mortality was a secondary endpoint in STICH (Surgical Treatment for Ischemic Heart Failure). The primary endpoint was all-cause mortality. And CABG’s impact on all-cause mortality was diminished in older STICH participants because of their greater comorbidity burden and the competing risk of noncardiovascular death, he added.
The take-home message is that cardiologists and heart surgeons need to carefully assess competing mortality risks before pursuing CABG in older patients, according to Dr. Velazquez.
Session cochair Kim A. Williams, MD, professor and chief of cardiology at Rush University Medical Center in Chicago, posed a direct question: “Is there an age cutoff for your group for bypass surgery?”
No, Dr. Velazquez replied. He pointed out that cardiovascular mortality remained the No. 1 cause of mortality across all age groups.
“If the expectation is that the major cause of fatal events is going to be cardiovascular, and CABG plus medical therapy reduces that risk consistently regardless of age, we think that there really is no particular age cutoff. There is a point at which the noncardiovascular risk predominates, but in the population we studied we did not see that point,” Dr. Velazquez added.
STICH was a 22-nation trial in which 1,212 patients with a left ventricular ejection fraction of 35% or less and coronary artery disease amenable to CABG were randomized to CABG plus optimal medical therapy or optimal medical therapy alone and followed for a median of 9.8 years (JACC Heart Fail. 2013;1[5]:400-8). For purposes of this secondary analysis, participants were divided into quartiles according to baseline age: Quartile 1 patients were up to 54 years old; quartile 2 were ages 55-60; quartile 3 were ages 61-67; and quartile 4 were ages 68 and up.
Older subjects had more comorbidities. All-cause mortality was significantly higher in older than younger patients: for CABG, 68% vs. 48% in quartiles 4 and 1, respectively; for medical therapy, 79% vs. 60% in the same two quartiles. In contrast, cardiovascular mortality did not differ significantly by age: It was 39% in quartile 4 and 35% in quartile 1 in the CABG group, and 53%, compared with 49%, in medically managed patients in quartiles 4 and 1.
For the secondary composite endpoint of all-cause mortality or cardiovascular hospitalization, the benefit of CABG plus medical management over medical management alone was significantly greater in younger than in older patients.
The rate of noncardiovascular mortality was 5.8% in quartiles 1 and 2, then leapt to 14.7% in quartile 3 and 21.1% in quartile 4.
Although the main focus of Dr. Velazquez’s presentation was the impact of CABG with advancing age, he said he found an important lesson in the younger population as well.
“We saw roughly a 40% relative risk reduction in all-cause mortality with CABG in the youngest quartile, compared with the three older groups. My interpretation of that data is that it’s probably not appropriate to avoid CABG in favor of another strategy in a younger patient when you see this kind of mortality benefit,” the cardiologist said.
One limitation of the STICH analysis, said session cochair Stephan Achenbach, MD, is that the study population was relatively young overall. The oldest patients in STICH were roughly the same age as the average patients undergoing CABG for left ventricular systolic dysfunction today at most centers, according to Dr. Achenbach, professor of cardiology at the University of Erlangen-Nuremberg (Germany).
Dr. Velazquez agreed. “I can’t speak as to whether these trial results would apply to the very elderly, patients age 90 and above,” he said.
Simultaneously with the presentation , the new STICH analysis was published online (Circulation. 2016 Aug 29. doi: 10.1161/CIRCULATIONAHA.116.024800).
STICH was funded by the National Institutes of Health. Dr. Velazquez reported having no relevant financial conflicts.
ROME – Coronary artery bypass surgery reduces cardiovascular mortality in heart failure patients with ischemic cardiomyopathy to a consistent extent regardless of age at the time of surgery, according to a secondary analysis from the landmark STICH trial, Eric J. Velazquez, MD, reported at the annual congress of the European Society of Cardiology.
“Cardiologists and cardiac surgeons can confidently offer patients CABG in addition to optimal medical therapy with the knowledge that cardiovascular mortality is reduced by CABG to a similar extent across all age groups in this trial through 10 years of follow-up,” said Dr. Velazquez, professor of medicine at Duke University in Durham, N.C.
However, that’s only part of the story. Cardiovascular mortality was a secondary endpoint in STICH (Surgical Treatment for Ischemic Heart Failure). The primary endpoint was all-cause mortality. And CABG’s impact on all-cause mortality was diminished in older STICH participants because of their greater comorbidity burden and the competing risk of noncardiovascular death, he added.
The take-home message is that cardiologists and heart surgeons need to carefully assess competing mortality risks before pursuing CABG in older patients, according to Dr. Velazquez.
Session cochair Kim A. Williams, MD, professor and chief of cardiology at Rush University Medical Center in Chicago, posed a direct question: “Is there an age cutoff for your group for bypass surgery?”
No, Dr. Velazquez replied. He pointed out that cardiovascular mortality remained the No. 1 cause of mortality across all age groups.
“If the expectation is that the major cause of fatal events is going to be cardiovascular, and CABG plus medical therapy reduces that risk consistently regardless of age, we think that there really is no particular age cutoff. There is a point at which the noncardiovascular risk predominates, but in the population we studied we did not see that point,” Dr. Velazquez added.
STICH was a 22-nation trial in which 1,212 patients with a left ventricular ejection fraction of 35% or less and coronary artery disease amenable to CABG were randomized to CABG plus optimal medical therapy or optimal medical therapy alone and followed for a median of 9.8 years (JACC Heart Fail. 2013;1[5]:400-8). For purposes of this secondary analysis, participants were divided into quartiles according to baseline age: Quartile 1 patients were up to 54 years old; quartile 2 were ages 55-60; quartile 3 were ages 61-67; and quartile 4 were ages 68 and up.
Older subjects had more comorbidities. All-cause mortality was significantly higher in older than younger patients: for CABG, 68% vs. 48% in quartiles 4 and 1, respectively; for medical therapy, 79% vs. 60% in the same two quartiles. In contrast, cardiovascular mortality did not differ significantly by age: It was 39% in quartile 4 and 35% in quartile 1 in the CABG group, and 53%, compared with 49%, in medically managed patients in quartiles 4 and 1.
For the secondary composite endpoint of all-cause mortality or cardiovascular hospitalization, the benefit of CABG plus medical management over medical management alone was significantly greater in younger than in older patients.
The rate of noncardiovascular mortality was 5.8% in quartiles 1 and 2, then leapt to 14.7% in quartile 3 and 21.1% in quartile 4.
Although the main focus of Dr. Velazquez’s presentation was the impact of CABG with advancing age, he said he found an important lesson in the younger population as well.
“We saw roughly a 40% relative risk reduction in all-cause mortality with CABG in the youngest quartile, compared with the three older groups. My interpretation of that data is that it’s probably not appropriate to avoid CABG in favor of another strategy in a younger patient when you see this kind of mortality benefit,” the cardiologist said.
One limitation of the STICH analysis, said session cochair Stephan Achenbach, MD, is that the study population was relatively young overall. The oldest patients in STICH were roughly the same age as the average patients undergoing CABG for left ventricular systolic dysfunction today at most centers, according to Dr. Achenbach, professor of cardiology at the University of Erlangen-Nuremberg (Germany).
Dr. Velazquez agreed. “I can’t speak as to whether these trial results would apply to the very elderly, patients age 90 and above,” he said.
Simultaneously with the presentation , the new STICH analysis was published online (Circulation. 2016 Aug 29. doi: 10.1161/CIRCULATIONAHA.116.024800).
STICH was funded by the National Institutes of Health. Dr. Velazquez reported having no relevant financial conflicts.
ROME – Coronary artery bypass surgery reduces cardiovascular mortality in heart failure patients with ischemic cardiomyopathy to a consistent extent regardless of age at the time of surgery, according to a secondary analysis from the landmark STICH trial, Eric J. Velazquez, MD, reported at the annual congress of the European Society of Cardiology.
“Cardiologists and cardiac surgeons can confidently offer patients CABG in addition to optimal medical therapy with the knowledge that cardiovascular mortality is reduced by CABG to a similar extent across all age groups in this trial through 10 years of follow-up,” said Dr. Velazquez, professor of medicine at Duke University in Durham, N.C.
However, that’s only part of the story. Cardiovascular mortality was a secondary endpoint in STICH (Surgical Treatment for Ischemic Heart Failure). The primary endpoint was all-cause mortality. And CABG’s impact on all-cause mortality was diminished in older STICH participants because of their greater comorbidity burden and the competing risk of noncardiovascular death, he added.
The take-home message is that cardiologists and heart surgeons need to carefully assess competing mortality risks before pursuing CABG in older patients, according to Dr. Velazquez.
Session cochair Kim A. Williams, MD, professor and chief of cardiology at Rush University Medical Center in Chicago, posed a direct question: “Is there an age cutoff for your group for bypass surgery?”
No, Dr. Velazquez replied. He pointed out that cardiovascular mortality remained the No. 1 cause of mortality across all age groups.
“If the expectation is that the major cause of fatal events is going to be cardiovascular, and CABG plus medical therapy reduces that risk consistently regardless of age, we think that there really is no particular age cutoff. There is a point at which the noncardiovascular risk predominates, but in the population we studied we did not see that point,” Dr. Velazquez added.
STICH was a 22-nation trial in which 1,212 patients with a left ventricular ejection fraction of 35% or less and coronary artery disease amenable to CABG were randomized to CABG plus optimal medical therapy or optimal medical therapy alone and followed for a median of 9.8 years (JACC Heart Fail. 2013;1[5]:400-8). For purposes of this secondary analysis, participants were divided into quartiles according to baseline age: Quartile 1 patients were up to 54 years old; quartile 2 were ages 55-60; quartile 3 were ages 61-67; and quartile 4 were ages 68 and up.
Older subjects had more comorbidities. All-cause mortality was significantly higher in older than younger patients: for CABG, 68% vs. 48% in quartiles 4 and 1, respectively; for medical therapy, 79% vs. 60% in the same two quartiles. In contrast, cardiovascular mortality did not differ significantly by age: It was 39% in quartile 4 and 35% in quartile 1 in the CABG group, and 53%, compared with 49%, in medically managed patients in quartiles 4 and 1.
For the secondary composite endpoint of all-cause mortality or cardiovascular hospitalization, the benefit of CABG plus medical management over medical management alone was significantly greater in younger than in older patients.
The rate of noncardiovascular mortality was 5.8% in quartiles 1 and 2, then leapt to 14.7% in quartile 3 and 21.1% in quartile 4.
Although the main focus of Dr. Velazquez’s presentation was the impact of CABG with advancing age, he said he found an important lesson in the younger population as well.
“We saw roughly a 40% relative risk reduction in all-cause mortality with CABG in the youngest quartile, compared with the three older groups. My interpretation of that data is that it’s probably not appropriate to avoid CABG in favor of another strategy in a younger patient when you see this kind of mortality benefit,” the cardiologist said.
One limitation of the STICH analysis, said session cochair Stephan Achenbach, MD, is that the study population was relatively young overall. The oldest patients in STICH were roughly the same age as the average patients undergoing CABG for left ventricular systolic dysfunction today at most centers, according to Dr. Achenbach, professor of cardiology at the University of Erlangen-Nuremberg (Germany).
Dr. Velazquez agreed. “I can’t speak as to whether these trial results would apply to the very elderly, patients age 90 and above,” he said.
Simultaneously with the presentation , the new STICH analysis was published online (Circulation. 2016 Aug 29. doi: 10.1161/CIRCULATIONAHA.116.024800).
STICH was funded by the National Institutes of Health. Dr. Velazquez reported having no relevant financial conflicts.
AT THE ESC CONGRESS 2016
Key clinical point: There should be no age cutoff in offering CABG to older patients with ischemic heart failure.
Major finding: CABG provided an absolute 14.4% reduction in cardiovascular mortality, compared with medical management, in both the youngest and oldest quartiles of patients with heart failure due to ischemic cardiomyopathy.
Data source: A secondary analysis of the STICH trial, in which 1,212 heart failure patients with ischemic cardiomyopathy were randomized to CABG plus medical therapy or medical therapy alone and followed for nearly 10 years.
Disclosures: The study was funded by the National Institutes of Health. The presenter reported having no relevant financial conflicts.
Guideline recommends optimal periop management of geriatric patients
SAN DIEGO – As the number of surgery patients over the age of 65 continues to burgeon, clinicians have a resource to help them provide optimal perioperative care to this patient population.
At the American College of Surgeons/National Surgical Quality Improvement Program National Conference, Ronnie A. Rosenthal, MD, discussed highlights from “Optimal Perioperative Management of the Geriatric Patient: A Best Practice Guideline from the ACS NSQIP/American Geriatrics Society,” which was published in January 2016.
Work on the guideline began in 2013, when a 28-member multidisciplinary panel began to conduct a structured search of Medline to identify systematic reviews, meta-analyses, practice guidelines, and clinical trials on the topic. The panel included experts from ACS, the ACS Geriatric Surgery Task Force, the American Society of Anesthesiologists, the American Geriatrics Society, and the AGS’ Geriatrics for Specialists Initiative. The 61-page document is divided into four categories: immediate preoperative period, intraoperative management, postoperative care, and care transitions.
Working with patients on goals
As noted in the guideline, a primary goal of the immediate preoperative period is to discuss with the patient his or her goals and expectations. Patient expectations are influenced by their treatment preferences. In fact, researchers have found that older patients are less likely to want a treatment – even if it results in cure – that may result in severe functional or cognitive impairment. For patients with existing advanced directives, organizations representing nurses, anesthesiologists, and surgeons all agree that there must be a “reconsideration” of these directives prior to surgery. A discussion that includes the new risks of the procedure must be conducted to ensure that the approach to potential life-threatening problems is consistent with the patient’s values.
Preoperative management of medications
Another recommendation for the preoperative period is to ensure that older patients have shorter fasts, have appropriate prophylactic antibiotics, continue medications with withdrawal potential, and discontinue medications that are not essential. The latter point is based on the Beers Criteria, a list of medications that are inappropriate or potentially inappropriate to use in older adults (J Am Geriatr Soc. 2015 Nov;63[11]:2227-46). “You want to discontinue as many inappropriate medications as possible, because one of the main side effects of their use is delirium, and you want to avoid that,” said Dr. Rosenthal, professor of surgery at the Yale University, New Haven, Conn., and one of the guideline authors.
Anesthesia and pain management
Intraoperative management strategies contained in the guideline include establishing an anesthetic approach and a perioperative analgesia pain plan, preventing postoperative nausea and vomiting, assessing patient safety in the OR, preventing predictable complications, and optimizing fluid management. Physiologic effects of anesthesia medications include changes in systemic vascular resistance, cardiac preload, baroreceptor responses, lung mechanics, oxygen diffusion, neurotransmitter function, and end-organ blood flow, among others. “These physiologic changes of aging have significant clinical implications,” Dr. Rosenthal noted. “These are variable among individuals and variable among organ systems, and it’s important that we pay attention to that. Because of this variability, there is insufficient evidence to recommend a single ‘best’ anesthetic plan for all older adults.”
The guideline recommends that each patient have an individualized pain plan that consists of a directed pain history and physical exam and is appropriately titrated for increased sensitivity. “It should include a prophylactic bowel regimen for anybody who’s on an opioid in particular,” she said. “We should avoid inappropriate medications like benzodiazepines, and we should use a multimodal therapy with opioid-sparing and regional techniques.”
Pulmonary considerations for anesthesia include susceptibility to hypocarbia and hypoxemia, and susceptibility to residual anesthetic effects. “Because of physiologic changes, the anesthesia medications aren’t metabolized in the same way,” she said. “Older people may have lower drug requirements and may not recover as quickly from the effects of these drugs. This can lead to respiratory compromise and also can increase the risk of aspiration.” Strategies to prevent pulmonary complications include using regional anesthesia when possible and avoiding the use of intermediate- and long-acting neuromuscular blocking agents. Dr. Rosenthal said that there is insufficient evidence in the current medical literature to recommend a single “best” intraoperative fluid management plan for all older adults. “Part of the reason it’s so difficult is because of the cardiac physiologic changes [with aging],” she explained. “Older people are susceptible to volume overload. On the other hand, they also may have an exaggerated decline in cardiac function if you give them too little fluid and they have insufficient preload. It’s a very fine line and that’s why it’s hard to recommend a single best strategy.”
Be alert to postoperative delirium
Postoperatively, the guideline recommends that care plans include controlling perioperative acute pain; addressing delirium/cognitive issues; preventing functional decline, falls, pressure ulcers, and urinary track infections; maintaining adequate nutrition; and avoiding pulmonary complications. Dr. Rosenthal underscored the importance of using the four-question Short Confusion Assessment Method (Short CAM) to assess for delirium. “For it to be delirium, there has to be evidence of acute change in mental status from baseline; it has to be acute and fluctuating, and characterized by inattention,” she said. “The patient also has to have either disorganized thinking or an altered level of consciousness.”
Many of the precipitating factors of delirium can be prevented by treating pain, watching medications, preventing dehydration and undernutrition, removing catheters and other devices when possible, preventing constipation, and using minimally invasive techniques to reduce the physiologic stress of surgery. “Sometimes symptoms of delirium are a warning sign that something else is going on, such as an infection, hypoxemia, electrolyte imbalance, neurological events, and major organ dysfunction,” she said. The first-line therapy for treating delirium as recommended in the guideline is a multicomponent intervention that focuses on frequent reorientation with voice, calendars, and clocks; eliminating use of restraints; having familiar objects in the room; and ensuring the use of assistive devices. The second-line therapy is antipsychotic medications at the lowest effective dose. “The mantra is start low and go slow,” she said.
Preventing postoperative functional decline
Another postoperative strategy in the guideline involves targeted fall prevention, such as having an assistive device at the bedside if used as an outpatient and prescribing early physical therapy focused on maintaining mobility as the primary event. “Every day an older patient is immobilized it takes at least 3 days to regain the lost function,” Dr. Rosenthal said. “And for older surgical patients, one in four experiences a significant decline in function by hospital discharge and 60% experience some loss of independence.” (The latter statistic comes from a study published online July 13, 2016, in JAMA Surgery: doi:10.1001/jamasurg.2016.1689.) Interventions for preventing functional decline include promotion of family participation in care, early mobilization, early physical/occupational therapy referral, geriatric consultation, comprehensive discharge planning, and nutritional support. She pointed out that an estimated 40% of community-dwelling elders and two-thirds of nursing home residents are either malnourished or “at risk” of malnutrition.
Transition of care
The final category in the guideline, transition of care, recommends an assessment of social support/home health needs, complete medication review, predischarge geriatric assessment, formal written discharge instructions, and communication with the patient’s primary care physician. “Common models of transitional care involve good coordination with the primary care physician,” she said. “There’s good data to show that people who see their primary care physician within 2 weeks of discharge do better in terms of readmission.”
Dr. Rosenthal reported having no financial disclosures.
SAN DIEGO – As the number of surgery patients over the age of 65 continues to burgeon, clinicians have a resource to help them provide optimal perioperative care to this patient population.
At the American College of Surgeons/National Surgical Quality Improvement Program National Conference, Ronnie A. Rosenthal, MD, discussed highlights from “Optimal Perioperative Management of the Geriatric Patient: A Best Practice Guideline from the ACS NSQIP/American Geriatrics Society,” which was published in January 2016.
Work on the guideline began in 2013, when a 28-member multidisciplinary panel began to conduct a structured search of Medline to identify systematic reviews, meta-analyses, practice guidelines, and clinical trials on the topic. The panel included experts from ACS, the ACS Geriatric Surgery Task Force, the American Society of Anesthesiologists, the American Geriatrics Society, and the AGS’ Geriatrics for Specialists Initiative. The 61-page document is divided into four categories: immediate preoperative period, intraoperative management, postoperative care, and care transitions.
Working with patients on goals
As noted in the guideline, a primary goal of the immediate preoperative period is to discuss with the patient his or her goals and expectations. Patient expectations are influenced by their treatment preferences. In fact, researchers have found that older patients are less likely to want a treatment – even if it results in cure – that may result in severe functional or cognitive impairment. For patients with existing advanced directives, organizations representing nurses, anesthesiologists, and surgeons all agree that there must be a “reconsideration” of these directives prior to surgery. A discussion that includes the new risks of the procedure must be conducted to ensure that the approach to potential life-threatening problems is consistent with the patient’s values.
Preoperative management of medications
Another recommendation for the preoperative period is to ensure that older patients have shorter fasts, have appropriate prophylactic antibiotics, continue medications with withdrawal potential, and discontinue medications that are not essential. The latter point is based on the Beers Criteria, a list of medications that are inappropriate or potentially inappropriate to use in older adults (J Am Geriatr Soc. 2015 Nov;63[11]:2227-46). “You want to discontinue as many inappropriate medications as possible, because one of the main side effects of their use is delirium, and you want to avoid that,” said Dr. Rosenthal, professor of surgery at the Yale University, New Haven, Conn., and one of the guideline authors.
Anesthesia and pain management
Intraoperative management strategies contained in the guideline include establishing an anesthetic approach and a perioperative analgesia pain plan, preventing postoperative nausea and vomiting, assessing patient safety in the OR, preventing predictable complications, and optimizing fluid management. Physiologic effects of anesthesia medications include changes in systemic vascular resistance, cardiac preload, baroreceptor responses, lung mechanics, oxygen diffusion, neurotransmitter function, and end-organ blood flow, among others. “These physiologic changes of aging have significant clinical implications,” Dr. Rosenthal noted. “These are variable among individuals and variable among organ systems, and it’s important that we pay attention to that. Because of this variability, there is insufficient evidence to recommend a single ‘best’ anesthetic plan for all older adults.”
The guideline recommends that each patient have an individualized pain plan that consists of a directed pain history and physical exam and is appropriately titrated for increased sensitivity. “It should include a prophylactic bowel regimen for anybody who’s on an opioid in particular,” she said. “We should avoid inappropriate medications like benzodiazepines, and we should use a multimodal therapy with opioid-sparing and regional techniques.”
Pulmonary considerations for anesthesia include susceptibility to hypocarbia and hypoxemia, and susceptibility to residual anesthetic effects. “Because of physiologic changes, the anesthesia medications aren’t metabolized in the same way,” she said. “Older people may have lower drug requirements and may not recover as quickly from the effects of these drugs. This can lead to respiratory compromise and also can increase the risk of aspiration.” Strategies to prevent pulmonary complications include using regional anesthesia when possible and avoiding the use of intermediate- and long-acting neuromuscular blocking agents. Dr. Rosenthal said that there is insufficient evidence in the current medical literature to recommend a single “best” intraoperative fluid management plan for all older adults. “Part of the reason it’s so difficult is because of the cardiac physiologic changes [with aging],” she explained. “Older people are susceptible to volume overload. On the other hand, they also may have an exaggerated decline in cardiac function if you give them too little fluid and they have insufficient preload. It’s a very fine line and that’s why it’s hard to recommend a single best strategy.”
Be alert to postoperative delirium
Postoperatively, the guideline recommends that care plans include controlling perioperative acute pain; addressing delirium/cognitive issues; preventing functional decline, falls, pressure ulcers, and urinary track infections; maintaining adequate nutrition; and avoiding pulmonary complications. Dr. Rosenthal underscored the importance of using the four-question Short Confusion Assessment Method (Short CAM) to assess for delirium. “For it to be delirium, there has to be evidence of acute change in mental status from baseline; it has to be acute and fluctuating, and characterized by inattention,” she said. “The patient also has to have either disorganized thinking or an altered level of consciousness.”
Many of the precipitating factors of delirium can be prevented by treating pain, watching medications, preventing dehydration and undernutrition, removing catheters and other devices when possible, preventing constipation, and using minimally invasive techniques to reduce the physiologic stress of surgery. “Sometimes symptoms of delirium are a warning sign that something else is going on, such as an infection, hypoxemia, electrolyte imbalance, neurological events, and major organ dysfunction,” she said. The first-line therapy for treating delirium as recommended in the guideline is a multicomponent intervention that focuses on frequent reorientation with voice, calendars, and clocks; eliminating use of restraints; having familiar objects in the room; and ensuring the use of assistive devices. The second-line therapy is antipsychotic medications at the lowest effective dose. “The mantra is start low and go slow,” she said.
Preventing postoperative functional decline
Another postoperative strategy in the guideline involves targeted fall prevention, such as having an assistive device at the bedside if used as an outpatient and prescribing early physical therapy focused on maintaining mobility as the primary event. “Every day an older patient is immobilized it takes at least 3 days to regain the lost function,” Dr. Rosenthal said. “And for older surgical patients, one in four experiences a significant decline in function by hospital discharge and 60% experience some loss of independence.” (The latter statistic comes from a study published online July 13, 2016, in JAMA Surgery: doi:10.1001/jamasurg.2016.1689.) Interventions for preventing functional decline include promotion of family participation in care, early mobilization, early physical/occupational therapy referral, geriatric consultation, comprehensive discharge planning, and nutritional support. She pointed out that an estimated 40% of community-dwelling elders and two-thirds of nursing home residents are either malnourished or “at risk” of malnutrition.
Transition of care
The final category in the guideline, transition of care, recommends an assessment of social support/home health needs, complete medication review, predischarge geriatric assessment, formal written discharge instructions, and communication with the patient’s primary care physician. “Common models of transitional care involve good coordination with the primary care physician,” she said. “There’s good data to show that people who see their primary care physician within 2 weeks of discharge do better in terms of readmission.”
Dr. Rosenthal reported having no financial disclosures.
SAN DIEGO – As the number of surgery patients over the age of 65 continues to burgeon, clinicians have a resource to help them provide optimal perioperative care to this patient population.
At the American College of Surgeons/National Surgical Quality Improvement Program National Conference, Ronnie A. Rosenthal, MD, discussed highlights from “Optimal Perioperative Management of the Geriatric Patient: A Best Practice Guideline from the ACS NSQIP/American Geriatrics Society,” which was published in January 2016.
Work on the guideline began in 2013, when a 28-member multidisciplinary panel began to conduct a structured search of Medline to identify systematic reviews, meta-analyses, practice guidelines, and clinical trials on the topic. The panel included experts from ACS, the ACS Geriatric Surgery Task Force, the American Society of Anesthesiologists, the American Geriatrics Society, and the AGS’ Geriatrics for Specialists Initiative. The 61-page document is divided into four categories: immediate preoperative period, intraoperative management, postoperative care, and care transitions.
Working with patients on goals
As noted in the guideline, a primary goal of the immediate preoperative period is to discuss with the patient his or her goals and expectations. Patient expectations are influenced by their treatment preferences. In fact, researchers have found that older patients are less likely to want a treatment – even if it results in cure – that may result in severe functional or cognitive impairment. For patients with existing advanced directives, organizations representing nurses, anesthesiologists, and surgeons all agree that there must be a “reconsideration” of these directives prior to surgery. A discussion that includes the new risks of the procedure must be conducted to ensure that the approach to potential life-threatening problems is consistent with the patient’s values.
Preoperative management of medications
Another recommendation for the preoperative period is to ensure that older patients have shorter fasts, have appropriate prophylactic antibiotics, continue medications with withdrawal potential, and discontinue medications that are not essential. The latter point is based on the Beers Criteria, a list of medications that are inappropriate or potentially inappropriate to use in older adults (J Am Geriatr Soc. 2015 Nov;63[11]:2227-46). “You want to discontinue as many inappropriate medications as possible, because one of the main side effects of their use is delirium, and you want to avoid that,” said Dr. Rosenthal, professor of surgery at the Yale University, New Haven, Conn., and one of the guideline authors.
Anesthesia and pain management
Intraoperative management strategies contained in the guideline include establishing an anesthetic approach and a perioperative analgesia pain plan, preventing postoperative nausea and vomiting, assessing patient safety in the OR, preventing predictable complications, and optimizing fluid management. Physiologic effects of anesthesia medications include changes in systemic vascular resistance, cardiac preload, baroreceptor responses, lung mechanics, oxygen diffusion, neurotransmitter function, and end-organ blood flow, among others. “These physiologic changes of aging have significant clinical implications,” Dr. Rosenthal noted. “These are variable among individuals and variable among organ systems, and it’s important that we pay attention to that. Because of this variability, there is insufficient evidence to recommend a single ‘best’ anesthetic plan for all older adults.”
The guideline recommends that each patient have an individualized pain plan that consists of a directed pain history and physical exam and is appropriately titrated for increased sensitivity. “It should include a prophylactic bowel regimen for anybody who’s on an opioid in particular,” she said. “We should avoid inappropriate medications like benzodiazepines, and we should use a multimodal therapy with opioid-sparing and regional techniques.”
Pulmonary considerations for anesthesia include susceptibility to hypocarbia and hypoxemia, and susceptibility to residual anesthetic effects. “Because of physiologic changes, the anesthesia medications aren’t metabolized in the same way,” she said. “Older people may have lower drug requirements and may not recover as quickly from the effects of these drugs. This can lead to respiratory compromise and also can increase the risk of aspiration.” Strategies to prevent pulmonary complications include using regional anesthesia when possible and avoiding the use of intermediate- and long-acting neuromuscular blocking agents. Dr. Rosenthal said that there is insufficient evidence in the current medical literature to recommend a single “best” intraoperative fluid management plan for all older adults. “Part of the reason it’s so difficult is because of the cardiac physiologic changes [with aging],” she explained. “Older people are susceptible to volume overload. On the other hand, they also may have an exaggerated decline in cardiac function if you give them too little fluid and they have insufficient preload. It’s a very fine line and that’s why it’s hard to recommend a single best strategy.”
Be alert to postoperative delirium
Postoperatively, the guideline recommends that care plans include controlling perioperative acute pain; addressing delirium/cognitive issues; preventing functional decline, falls, pressure ulcers, and urinary track infections; maintaining adequate nutrition; and avoiding pulmonary complications. Dr. Rosenthal underscored the importance of using the four-question Short Confusion Assessment Method (Short CAM) to assess for delirium. “For it to be delirium, there has to be evidence of acute change in mental status from baseline; it has to be acute and fluctuating, and characterized by inattention,” she said. “The patient also has to have either disorganized thinking or an altered level of consciousness.”
Many of the precipitating factors of delirium can be prevented by treating pain, watching medications, preventing dehydration and undernutrition, removing catheters and other devices when possible, preventing constipation, and using minimally invasive techniques to reduce the physiologic stress of surgery. “Sometimes symptoms of delirium are a warning sign that something else is going on, such as an infection, hypoxemia, electrolyte imbalance, neurological events, and major organ dysfunction,” she said. The first-line therapy for treating delirium as recommended in the guideline is a multicomponent intervention that focuses on frequent reorientation with voice, calendars, and clocks; eliminating use of restraints; having familiar objects in the room; and ensuring the use of assistive devices. The second-line therapy is antipsychotic medications at the lowest effective dose. “The mantra is start low and go slow,” she said.
Preventing postoperative functional decline
Another postoperative strategy in the guideline involves targeted fall prevention, such as having an assistive device at the bedside if used as an outpatient and prescribing early physical therapy focused on maintaining mobility as the primary event. “Every day an older patient is immobilized it takes at least 3 days to regain the lost function,” Dr. Rosenthal said. “And for older surgical patients, one in four experiences a significant decline in function by hospital discharge and 60% experience some loss of independence.” (The latter statistic comes from a study published online July 13, 2016, in JAMA Surgery: doi:10.1001/jamasurg.2016.1689.) Interventions for preventing functional decline include promotion of family participation in care, early mobilization, early physical/occupational therapy referral, geriatric consultation, comprehensive discharge planning, and nutritional support. She pointed out that an estimated 40% of community-dwelling elders and two-thirds of nursing home residents are either malnourished or “at risk” of malnutrition.
Transition of care
The final category in the guideline, transition of care, recommends an assessment of social support/home health needs, complete medication review, predischarge geriatric assessment, formal written discharge instructions, and communication with the patient’s primary care physician. “Common models of transitional care involve good coordination with the primary care physician,” she said. “There’s good data to show that people who see their primary care physician within 2 weeks of discharge do better in terms of readmission.”
Dr. Rosenthal reported having no financial disclosures.
EXPERT ANALYSIS AT THE ACS NSQIP NATIONAL CONFERENCE
