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GOP health reform: Essential health benefits, community rating under fire
Republicans are targeting two key consumer protections in their latest attempt to gain enough votes to pass the American Health Care Act, phase 1 of their Affordable Care Act repeal and replace plan.
On the chopping block are the essential health care benefits package and so-called community rating provisions – which prevent insurers from charging significantly more for older patients and those with preexisting conditions.
“Obamacare is already in a race to the bottom in terms of quality coverage for the sick and that’s because of the law’s community rating provisions, which penalize high-quality coverage for the sick,” Michael F. Cannon, director of health policy studies at the Cato Institute, said in an interview. “The [AHCA] would arguably accelerate that race to the bottom. The waiver provision in this amendment definitely would and it would because the bill would allow states to waive the community rating provisions, but only for people who were not previously insured.”
The waiver provisions would “increase premiums for the previously uninsured and discourage them from enrolling,” Mr. Cannon predicted.
David Anderson, research associate at the Margolis Center for Health Policy at Duke University, Durham, N.C., said that, if a state elects to take a waiver, so-called high-cost patients “such as individuals with cancer, individuals with cystic fibrosis, individuals with coagulation disorders, [would be] shrugged to the side into a high-cost risk pool or some kind of risk sharing ... with their own premium pool.” This could lower premium costs for healthy patients, he added.
This could be enhanced by narrowing the essential health benefits. For example, Mr. Anderson said that a state could keep the drug benefit, but apply for a waiver to narrow its coverage for all generics plus a limited list of brand names.
“Someone with cystic fibrosis with a $300,000-a-year medication will not have that covered and will be put in the high-cost risk pool,” Mr. Anderson said. “What it does is that it makes insurance cheaper for individuals who are highly unlikely to be high cost, and it makes it much more expensive for any individuals with known high-cost conditions.”
The draft amendment also would make it easier a whole lot easier to get such waivers approved: If enacted, the legislation would give default approval of such waivers and allow just 60 days for the Department of Health & Human Services to deny waiver request.
States would be able to apply for a waiver from the essential health benefits requirements for the 2020 plan year and a waiver to charge higher premiums to certain individuals for the 2019 plan year.
Waivers to change the essential health benefits package would need to meet one or more of the following conditions:
- Reduce average premiums.
- Increase enrollment.
- Stabilize the health insurance market.
- Stabilize premiums for individuals with preexisting conditions.
- Increase consumer choice.
For a state to change community rating provisions, its waiver also would need to create a mechanism, such as high-risk pools, to help those patients. Funding for these pools is provided for in the AHCA, but has been criticized as being inadequate on a national level.
Mr. Cannon of the Cato Institute predicted that such waivers ultimately would lead to more adverse selections for people needing comprehensive coverage and could force more people to lose coverage than to gain access to affordable, high-quality plans.
“If you waive essential health benefits in a community-rated market, you get even more adverse selection against comprehensive plans that sick people want, so those plans disappear,” Mr. Cannon said. “They either disappear because the insurers stop offering them or they disappear because insurers try to make the coverage worse, because Obamacare penalizes them if they don’t make coverage worse.”
He said these waivers provide little incentive for health insurers to stay in the individual markets and they could, as they are already, flee the individual markets.
The AHCA is phase 1 of the GOP repeal and replace plan. Congressional Republicans want to use the budget reconciliation process for the AHCA, so that they need only a simple majority to change revenue-generating provisions of the ACA. Phase 2 is a comprehensive review of all federal health care regulations and phase 3 is slated to be new legislation to replace the ACA with a new health care reform plan, which will require a two-thirds majority in the Senate to pass.
Republicans are targeting two key consumer protections in their latest attempt to gain enough votes to pass the American Health Care Act, phase 1 of their Affordable Care Act repeal and replace plan.
On the chopping block are the essential health care benefits package and so-called community rating provisions – which prevent insurers from charging significantly more for older patients and those with preexisting conditions.
“Obamacare is already in a race to the bottom in terms of quality coverage for the sick and that’s because of the law’s community rating provisions, which penalize high-quality coverage for the sick,” Michael F. Cannon, director of health policy studies at the Cato Institute, said in an interview. “The [AHCA] would arguably accelerate that race to the bottom. The waiver provision in this amendment definitely would and it would because the bill would allow states to waive the community rating provisions, but only for people who were not previously insured.”
The waiver provisions would “increase premiums for the previously uninsured and discourage them from enrolling,” Mr. Cannon predicted.
David Anderson, research associate at the Margolis Center for Health Policy at Duke University, Durham, N.C., said that, if a state elects to take a waiver, so-called high-cost patients “such as individuals with cancer, individuals with cystic fibrosis, individuals with coagulation disorders, [would be] shrugged to the side into a high-cost risk pool or some kind of risk sharing ... with their own premium pool.” This could lower premium costs for healthy patients, he added.
This could be enhanced by narrowing the essential health benefits. For example, Mr. Anderson said that a state could keep the drug benefit, but apply for a waiver to narrow its coverage for all generics plus a limited list of brand names.
“Someone with cystic fibrosis with a $300,000-a-year medication will not have that covered and will be put in the high-cost risk pool,” Mr. Anderson said. “What it does is that it makes insurance cheaper for individuals who are highly unlikely to be high cost, and it makes it much more expensive for any individuals with known high-cost conditions.”
The draft amendment also would make it easier a whole lot easier to get such waivers approved: If enacted, the legislation would give default approval of such waivers and allow just 60 days for the Department of Health & Human Services to deny waiver request.
States would be able to apply for a waiver from the essential health benefits requirements for the 2020 plan year and a waiver to charge higher premiums to certain individuals for the 2019 plan year.
Waivers to change the essential health benefits package would need to meet one or more of the following conditions:
- Reduce average premiums.
- Increase enrollment.
- Stabilize the health insurance market.
- Stabilize premiums for individuals with preexisting conditions.
- Increase consumer choice.
For a state to change community rating provisions, its waiver also would need to create a mechanism, such as high-risk pools, to help those patients. Funding for these pools is provided for in the AHCA, but has been criticized as being inadequate on a national level.
Mr. Cannon of the Cato Institute predicted that such waivers ultimately would lead to more adverse selections for people needing comprehensive coverage and could force more people to lose coverage than to gain access to affordable, high-quality plans.
“If you waive essential health benefits in a community-rated market, you get even more adverse selection against comprehensive plans that sick people want, so those plans disappear,” Mr. Cannon said. “They either disappear because the insurers stop offering them or they disappear because insurers try to make the coverage worse, because Obamacare penalizes them if they don’t make coverage worse.”
He said these waivers provide little incentive for health insurers to stay in the individual markets and they could, as they are already, flee the individual markets.
The AHCA is phase 1 of the GOP repeal and replace plan. Congressional Republicans want to use the budget reconciliation process for the AHCA, so that they need only a simple majority to change revenue-generating provisions of the ACA. Phase 2 is a comprehensive review of all federal health care regulations and phase 3 is slated to be new legislation to replace the ACA with a new health care reform plan, which will require a two-thirds majority in the Senate to pass.
Republicans are targeting two key consumer protections in their latest attempt to gain enough votes to pass the American Health Care Act, phase 1 of their Affordable Care Act repeal and replace plan.
On the chopping block are the essential health care benefits package and so-called community rating provisions – which prevent insurers from charging significantly more for older patients and those with preexisting conditions.
“Obamacare is already in a race to the bottom in terms of quality coverage for the sick and that’s because of the law’s community rating provisions, which penalize high-quality coverage for the sick,” Michael F. Cannon, director of health policy studies at the Cato Institute, said in an interview. “The [AHCA] would arguably accelerate that race to the bottom. The waiver provision in this amendment definitely would and it would because the bill would allow states to waive the community rating provisions, but only for people who were not previously insured.”
The waiver provisions would “increase premiums for the previously uninsured and discourage them from enrolling,” Mr. Cannon predicted.
David Anderson, research associate at the Margolis Center for Health Policy at Duke University, Durham, N.C., said that, if a state elects to take a waiver, so-called high-cost patients “such as individuals with cancer, individuals with cystic fibrosis, individuals with coagulation disorders, [would be] shrugged to the side into a high-cost risk pool or some kind of risk sharing ... with their own premium pool.” This could lower premium costs for healthy patients, he added.
This could be enhanced by narrowing the essential health benefits. For example, Mr. Anderson said that a state could keep the drug benefit, but apply for a waiver to narrow its coverage for all generics plus a limited list of brand names.
“Someone with cystic fibrosis with a $300,000-a-year medication will not have that covered and will be put in the high-cost risk pool,” Mr. Anderson said. “What it does is that it makes insurance cheaper for individuals who are highly unlikely to be high cost, and it makes it much more expensive for any individuals with known high-cost conditions.”
The draft amendment also would make it easier a whole lot easier to get such waivers approved: If enacted, the legislation would give default approval of such waivers and allow just 60 days for the Department of Health & Human Services to deny waiver request.
States would be able to apply for a waiver from the essential health benefits requirements for the 2020 plan year and a waiver to charge higher premiums to certain individuals for the 2019 plan year.
Waivers to change the essential health benefits package would need to meet one or more of the following conditions:
- Reduce average premiums.
- Increase enrollment.
- Stabilize the health insurance market.
- Stabilize premiums for individuals with preexisting conditions.
- Increase consumer choice.
For a state to change community rating provisions, its waiver also would need to create a mechanism, such as high-risk pools, to help those patients. Funding for these pools is provided for in the AHCA, but has been criticized as being inadequate on a national level.
Mr. Cannon of the Cato Institute predicted that such waivers ultimately would lead to more adverse selections for people needing comprehensive coverage and could force more people to lose coverage than to gain access to affordable, high-quality plans.
“If you waive essential health benefits in a community-rated market, you get even more adverse selection against comprehensive plans that sick people want, so those plans disappear,” Mr. Cannon said. “They either disappear because the insurers stop offering them or they disappear because insurers try to make the coverage worse, because Obamacare penalizes them if they don’t make coverage worse.”
He said these waivers provide little incentive for health insurers to stay in the individual markets and they could, as they are already, flee the individual markets.
The AHCA is phase 1 of the GOP repeal and replace plan. Congressional Republicans want to use the budget reconciliation process for the AHCA, so that they need only a simple majority to change revenue-generating provisions of the ACA. Phase 2 is a comprehensive review of all federal health care regulations and phase 3 is slated to be new legislation to replace the ACA with a new health care reform plan, which will require a two-thirds majority in the Senate to pass.
Antithrombotics no deterrent for emergent lap appendectomy
HOUSTON – Few studies have looked at the risk of irreversible antithrombotic therapy in patients who need emergent or urgent laparoscopic appendectomy, but a new study showed that the operation poses no significantly greater risk for such patients, compared with people who are not on antithrombotics.
The study’s findings do not apply to all patients on anticoagulation, specifically those on new novel oral anticoagulants (NOACs), said Christopher Pearcy, MD, of Methodist Dallas Medical Center.
NOAC agents include dabigatran, rivaroxaban, and apixaban.
Appendicitis is the third most common indication for abdominal surgery in the elderly, Dr. Pearcy noted, and their mortality rates are eight times greater than those of younger patients. However, these patients often proceed to operation with minimal workup, “given that laparoscopic appendectomy is a relatively benign procedure,” he said at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.
The retrospective study evaluated two groups of 195 patients who had urgent or emergent laparoscopic appendectomy at three centers from 2010 to 2014. One group was on irreversible antithrombotic therapy, and the other served as controls.
The primary outcomes were blood loss, transfusion requirement, and mortality. Secondary outcomes were duration of operation, length of hospital stay, rates of infections, complications, and 30-day readmissions.
“Compared with controls, we didn’t find any significant difference in any outcome whatsoever after laparoscopic appendectomy in patients on prehospital antithrombotic therapy,” Dr. Pearcy said.
Specifically, average estimated blood loss was 18 cc in controls vs. 22 cc in patients on antithrombotics, and mortality was 0% in the former vs. 1% in the latter. Patients on antithrombotics had a lower rate of complications: 3% vs. 11%.
Dr. Pearcy discussed a case of a 70-year-old man with acute appendicitis. He had a history of coronary artery disease, hypertension, hyperlipidemia, type 2 diabetes, and stroke, and was taking clopidogrel and aspirin daily.
“Is it safe to proceed with surgery given this patient’s irreversible antithrombotic therapy? We would say yes,” he said.
Dr. Pearcy reported having no financial disclosures.
HOUSTON – Few studies have looked at the risk of irreversible antithrombotic therapy in patients who need emergent or urgent laparoscopic appendectomy, but a new study showed that the operation poses no significantly greater risk for such patients, compared with people who are not on antithrombotics.
The study’s findings do not apply to all patients on anticoagulation, specifically those on new novel oral anticoagulants (NOACs), said Christopher Pearcy, MD, of Methodist Dallas Medical Center.
NOAC agents include dabigatran, rivaroxaban, and apixaban.
Appendicitis is the third most common indication for abdominal surgery in the elderly, Dr. Pearcy noted, and their mortality rates are eight times greater than those of younger patients. However, these patients often proceed to operation with minimal workup, “given that laparoscopic appendectomy is a relatively benign procedure,” he said at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.
The retrospective study evaluated two groups of 195 patients who had urgent or emergent laparoscopic appendectomy at three centers from 2010 to 2014. One group was on irreversible antithrombotic therapy, and the other served as controls.
The primary outcomes were blood loss, transfusion requirement, and mortality. Secondary outcomes were duration of operation, length of hospital stay, rates of infections, complications, and 30-day readmissions.
“Compared with controls, we didn’t find any significant difference in any outcome whatsoever after laparoscopic appendectomy in patients on prehospital antithrombotic therapy,” Dr. Pearcy said.
Specifically, average estimated blood loss was 18 cc in controls vs. 22 cc in patients on antithrombotics, and mortality was 0% in the former vs. 1% in the latter. Patients on antithrombotics had a lower rate of complications: 3% vs. 11%.
Dr. Pearcy discussed a case of a 70-year-old man with acute appendicitis. He had a history of coronary artery disease, hypertension, hyperlipidemia, type 2 diabetes, and stroke, and was taking clopidogrel and aspirin daily.
“Is it safe to proceed with surgery given this patient’s irreversible antithrombotic therapy? We would say yes,” he said.
Dr. Pearcy reported having no financial disclosures.
HOUSTON – Few studies have looked at the risk of irreversible antithrombotic therapy in patients who need emergent or urgent laparoscopic appendectomy, but a new study showed that the operation poses no significantly greater risk for such patients, compared with people who are not on antithrombotics.
The study’s findings do not apply to all patients on anticoagulation, specifically those on new novel oral anticoagulants (NOACs), said Christopher Pearcy, MD, of Methodist Dallas Medical Center.
NOAC agents include dabigatran, rivaroxaban, and apixaban.
Appendicitis is the third most common indication for abdominal surgery in the elderly, Dr. Pearcy noted, and their mortality rates are eight times greater than those of younger patients. However, these patients often proceed to operation with minimal workup, “given that laparoscopic appendectomy is a relatively benign procedure,” he said at the annual meeting of the Society of American Gastrointestinal and Endoscopic Surgeons.
The retrospective study evaluated two groups of 195 patients who had urgent or emergent laparoscopic appendectomy at three centers from 2010 to 2014. One group was on irreversible antithrombotic therapy, and the other served as controls.
The primary outcomes were blood loss, transfusion requirement, and mortality. Secondary outcomes were duration of operation, length of hospital stay, rates of infections, complications, and 30-day readmissions.
“Compared with controls, we didn’t find any significant difference in any outcome whatsoever after laparoscopic appendectomy in patients on prehospital antithrombotic therapy,” Dr. Pearcy said.
Specifically, average estimated blood loss was 18 cc in controls vs. 22 cc in patients on antithrombotics, and mortality was 0% in the former vs. 1% in the latter. Patients on antithrombotics had a lower rate of complications: 3% vs. 11%.
Dr. Pearcy discussed a case of a 70-year-old man with acute appendicitis. He had a history of coronary artery disease, hypertension, hyperlipidemia, type 2 diabetes, and stroke, and was taking clopidogrel and aspirin daily.
“Is it safe to proceed with surgery given this patient’s irreversible antithrombotic therapy? We would say yes,” he said.
Dr. Pearcy reported having no financial disclosures.
AT SAGES 2017
Key clinical point: Emergent laparoscopic appendectomy poses no significant risk for patients on irreversible antithrombotic therapy.
Major finding: Average estimated blood loss was 18 cc in controls vs. 22 cc in patients on antithrombotics, and mortality was 0% vs. 1%, respectively.
Data source: A retrospective study of 390 patients who had urgent or emergent laparoscopic appendectomy at three centers from 2010 to 2014.
Disclosures: Dr. Pearcy reported having no financial disclosures.
CRT-D beneficial in mild HF with ejection fraction above 30%
WASHINGTON – Patients with mild heart failure symptoms, left bundle branch block, and a left ventricular ejection fraction of 31% to 44% who received cardiac resynchronization therapy with a built-in defibrillator experienced a significant reduction in all-cause mortality, compared with those randomized to an implantable cardioverter-defibrillator alone during 7 years of follow-up.
These results from a new MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy) long-term follow-up substudy “suggest that patients with a relatively preserved ejection fraction greater than 30% benefit from CRT-D [cardiac resynchronization therapy defibrillator] and could potentially be considered for this therapy,” said Katherine Vermilye, MD, at the annual meeting of the American College of Cardiology.
In a subsequent publication, the MADIT-CRT investigators reported that, with extension of follow-up to 7 years, CRT-D also provided a significant benefit in terms of all-cause mortality in addition to the reduced rate of heart failure events (N Engl J Med. 2014 May 1;370[18]:1694-701).
However, even though an LVEF of 30% or less was a requirement for participation in MADIT-CRT, it turned out that, when the initial screening echocardiograms were eventually analyzed in a central core laboratory, one-third of study participants actually had a baseline LVEF of 31% to 44%, with the majority of excessive values being in the 31%-35% range.
Dr. Vermilye, of the University of Rochester in New York, presented a post hoc analysis of long-term outcomes in the subgroup having a baseline LVEF greater than 30%. They totaled 450 of 1,224 MADIT-CRT participants with left bundle branch block. They were significantly older and more likely to be female than the 824 subjects with an LVEF of 30% or less. They also had a shorter QRS duration – an average of 160 ms, versus 165 ms in patients with an LVEF of 30% or lower – and a smaller baseline left ventricular end systolic volume of 151 mL, compared with 196 mL in patients with a lower LVEF.
In a multivariate Cox regression analysis adjusted for potential confounders, CRT-D in patients with a baseline LVEF greater than 30% was associated with a 54% reduction in the risk of all-cause mortality at 7 years of follow-up, compared with receipt of an ICD-only device and with a smaller yet significant 31% reduction in risk in those with an LVEF of 30% or less. Worsening heart failure events were reduced by 64% in patients with a baseline LVEF greater than 30% who received CRT-D, compared with ICD-only, and by 54% in those with a lower baseline LVEF.
The reduction in all-cause mortality seen with CRT-D was confined to patients who were high responders to CRT as defined echocardiographically by at least a 35% change in left ventricular end systolic volume 1 year post implantation. They had an 85% reduction in the risk of death during 7 years of follow-up with CRT-D if their baseline LVEF was greater than 30% and a 58% relative risk reduction if their LVEF was 30% or less.
In contrast, CRT-D brought a significantly reduced risk of heart failure events regardless of whether a patient was a low or high responder, although the magnitude of benefit was greater in the high responders. Among patients with a baseline LVEF greater than 30%, CRT-D low responders had a 52% reduction in risk of heart failure events, compared with ICD recipients, while CRT-D high responders had an 81% relative risk reduction. Similarly, in patients with a baseline LVEF of 30% or less, CRT-D low responders had 48% reduction in heart failure events and high responders had a 79% risk reduction, compared with the ICD-only group.
Because this is a post hoc analysis, these new MADIT-CRT findings require validation in future studies, Dr. Vermilye observed.
MADIT-CRT was supported by Boston Scientific. Dr.. Vermilye reported having no financial conflicts.
The authors demonstrate the benefit of cardiac resynchronization therapy in patients with a defibrillator. The reduction in mortality at 5 years was greater in high responders to CRT-D, although overall mortality was significantly reduced in all comers.
The authors demonstrate the benefit of cardiac resynchronization therapy in patients with a defibrillator. The reduction in mortality at 5 years was greater in high responders to CRT-D, although overall mortality was significantly reduced in all comers.
The authors demonstrate the benefit of cardiac resynchronization therapy in patients with a defibrillator. The reduction in mortality at 5 years was greater in high responders to CRT-D, although overall mortality was significantly reduced in all comers.
WASHINGTON – Patients with mild heart failure symptoms, left bundle branch block, and a left ventricular ejection fraction of 31% to 44% who received cardiac resynchronization therapy with a built-in defibrillator experienced a significant reduction in all-cause mortality, compared with those randomized to an implantable cardioverter-defibrillator alone during 7 years of follow-up.
These results from a new MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy) long-term follow-up substudy “suggest that patients with a relatively preserved ejection fraction greater than 30% benefit from CRT-D [cardiac resynchronization therapy defibrillator] and could potentially be considered for this therapy,” said Katherine Vermilye, MD, at the annual meeting of the American College of Cardiology.
In a subsequent publication, the MADIT-CRT investigators reported that, with extension of follow-up to 7 years, CRT-D also provided a significant benefit in terms of all-cause mortality in addition to the reduced rate of heart failure events (N Engl J Med. 2014 May 1;370[18]:1694-701).
However, even though an LVEF of 30% or less was a requirement for participation in MADIT-CRT, it turned out that, when the initial screening echocardiograms were eventually analyzed in a central core laboratory, one-third of study participants actually had a baseline LVEF of 31% to 44%, with the majority of excessive values being in the 31%-35% range.
Dr. Vermilye, of the University of Rochester in New York, presented a post hoc analysis of long-term outcomes in the subgroup having a baseline LVEF greater than 30%. They totaled 450 of 1,224 MADIT-CRT participants with left bundle branch block. They were significantly older and more likely to be female than the 824 subjects with an LVEF of 30% or less. They also had a shorter QRS duration – an average of 160 ms, versus 165 ms in patients with an LVEF of 30% or lower – and a smaller baseline left ventricular end systolic volume of 151 mL, compared with 196 mL in patients with a lower LVEF.
In a multivariate Cox regression analysis adjusted for potential confounders, CRT-D in patients with a baseline LVEF greater than 30% was associated with a 54% reduction in the risk of all-cause mortality at 7 years of follow-up, compared with receipt of an ICD-only device and with a smaller yet significant 31% reduction in risk in those with an LVEF of 30% or less. Worsening heart failure events were reduced by 64% in patients with a baseline LVEF greater than 30% who received CRT-D, compared with ICD-only, and by 54% in those with a lower baseline LVEF.
The reduction in all-cause mortality seen with CRT-D was confined to patients who were high responders to CRT as defined echocardiographically by at least a 35% change in left ventricular end systolic volume 1 year post implantation. They had an 85% reduction in the risk of death during 7 years of follow-up with CRT-D if their baseline LVEF was greater than 30% and a 58% relative risk reduction if their LVEF was 30% or less.
In contrast, CRT-D brought a significantly reduced risk of heart failure events regardless of whether a patient was a low or high responder, although the magnitude of benefit was greater in the high responders. Among patients with a baseline LVEF greater than 30%, CRT-D low responders had a 52% reduction in risk of heart failure events, compared with ICD recipients, while CRT-D high responders had an 81% relative risk reduction. Similarly, in patients with a baseline LVEF of 30% or less, CRT-D low responders had 48% reduction in heart failure events and high responders had a 79% risk reduction, compared with the ICD-only group.
Because this is a post hoc analysis, these new MADIT-CRT findings require validation in future studies, Dr. Vermilye observed.
MADIT-CRT was supported by Boston Scientific. Dr.. Vermilye reported having no financial conflicts.
WASHINGTON – Patients with mild heart failure symptoms, left bundle branch block, and a left ventricular ejection fraction of 31% to 44% who received cardiac resynchronization therapy with a built-in defibrillator experienced a significant reduction in all-cause mortality, compared with those randomized to an implantable cardioverter-defibrillator alone during 7 years of follow-up.
These results from a new MADIT-CRT (Multicenter Automatic Defibrillator Implantation Trial With Cardiac Resynchronization Therapy) long-term follow-up substudy “suggest that patients with a relatively preserved ejection fraction greater than 30% benefit from CRT-D [cardiac resynchronization therapy defibrillator] and could potentially be considered for this therapy,” said Katherine Vermilye, MD, at the annual meeting of the American College of Cardiology.
In a subsequent publication, the MADIT-CRT investigators reported that, with extension of follow-up to 7 years, CRT-D also provided a significant benefit in terms of all-cause mortality in addition to the reduced rate of heart failure events (N Engl J Med. 2014 May 1;370[18]:1694-701).
However, even though an LVEF of 30% or less was a requirement for participation in MADIT-CRT, it turned out that, when the initial screening echocardiograms were eventually analyzed in a central core laboratory, one-third of study participants actually had a baseline LVEF of 31% to 44%, with the majority of excessive values being in the 31%-35% range.
Dr. Vermilye, of the University of Rochester in New York, presented a post hoc analysis of long-term outcomes in the subgroup having a baseline LVEF greater than 30%. They totaled 450 of 1,224 MADIT-CRT participants with left bundle branch block. They were significantly older and more likely to be female than the 824 subjects with an LVEF of 30% or less. They also had a shorter QRS duration – an average of 160 ms, versus 165 ms in patients with an LVEF of 30% or lower – and a smaller baseline left ventricular end systolic volume of 151 mL, compared with 196 mL in patients with a lower LVEF.
In a multivariate Cox regression analysis adjusted for potential confounders, CRT-D in patients with a baseline LVEF greater than 30% was associated with a 54% reduction in the risk of all-cause mortality at 7 years of follow-up, compared with receipt of an ICD-only device and with a smaller yet significant 31% reduction in risk in those with an LVEF of 30% or less. Worsening heart failure events were reduced by 64% in patients with a baseline LVEF greater than 30% who received CRT-D, compared with ICD-only, and by 54% in those with a lower baseline LVEF.
The reduction in all-cause mortality seen with CRT-D was confined to patients who were high responders to CRT as defined echocardiographically by at least a 35% change in left ventricular end systolic volume 1 year post implantation. They had an 85% reduction in the risk of death during 7 years of follow-up with CRT-D if their baseline LVEF was greater than 30% and a 58% relative risk reduction if their LVEF was 30% or less.
In contrast, CRT-D brought a significantly reduced risk of heart failure events regardless of whether a patient was a low or high responder, although the magnitude of benefit was greater in the high responders. Among patients with a baseline LVEF greater than 30%, CRT-D low responders had a 52% reduction in risk of heart failure events, compared with ICD recipients, while CRT-D high responders had an 81% relative risk reduction. Similarly, in patients with a baseline LVEF of 30% or less, CRT-D low responders had 48% reduction in heart failure events and high responders had a 79% risk reduction, compared with the ICD-only group.
Because this is a post hoc analysis, these new MADIT-CRT findings require validation in future studies, Dr. Vermilye observed.
MADIT-CRT was supported by Boston Scientific. Dr.. Vermilye reported having no financial conflicts.
AT ACC 2017
Key clinical point:
Major finding: The risk of all-cause mortality was reduced by 54% with CRT-D as compared with an ICD alone in MADIT-CRT participants with a baseline LVEF greater than 30% and by 31% in those with an LVEF of 30% or lower.
Data source: An analysis of 7-year rates of all-cause mortality and worsening heart failure events in 1,224 MADIT-CRT participants with left bundle branch block, 450 of whom had a baseline LVEF greater than 30%.
Disclosures: The MADIT-CRT study was supported by Boston Scientific. The presenter reported having no financial conflicts.
Hospital infections top WHO’s list of priority pathogens
The World Health Organization is urging governments to focus antibiotic research efforts on a list of urgent bacterial threats, topped by several increasingly powerful superbugs that cause hospital-based infections and other potentially deadly conditions.
The WHO listed the top 20 bacteria that it believes are most harmful to human health, other than mycobacteria such as Mycobacterium tuberculosis, which causes tuberculosis. The germ was not included in the list because it’s generally accepted to be the most urgent priority for new antibiotic research and development, Marie-Paule Kieny, PhD, a WHO assistant director, said at a press conference.
The priority list is needed because the antibiotic pipeline is “practically dry,” thanks to scientific research challenges and a lack of financial incentives, according to Dr. Kieny. “Antibiotics are generally used for the short term, unlike therapies for chronic diseases, which bring in much higher returns on investment,” she said. The list “is intended to signal to the scientific community and the pharmaceutical industry the areas they should focus on to address urgent public health threats.”
The WHO list begins with Priority 1/“Critical” pathogens that it believes most urgently need to be targeted through antibiotic research and development: Acinetobacter baumannii, carbapenem-resistant; Pseudomonas aeruginosa, carbapenem-resistant; and Enterobacteriaceae (including Klebsiella pneumonia, Escherichia coli, Enterobacter spp., Serratia spp., Proteus spp., Providencia spp., and Morganella spp.), carbapenem-resistant, extended-spectrum beta-lactamase–producing.
“These bacteria are responsible for severe infections and high mortality rates, mostly in hospitalized patients, transplant recipients, those receiving chemotherapy, or patients in intensive care units,” Dr. Kieny said. “While these bacteria are not widespread and do not generally affect healthy individuals, the burden for patients and society is now alarming – and new, effective therapies are imperative.”
Priority 2/”High” pathogens are Enterococcus faecium, vancomycin-resistant; Staphylococcus aureus, methicillin-resistant, vancomycin intermediate and resistant; Helicobacter pylori, clarithromycin-resistant; Campylobacter, fluoroquinolone-resistant; Salmonella spp., fluoroquinolone-resistant; Neisseria gonorrhoeae, third-generation cephalosporin-resistant and fluoroquinolone-resistant.
Pathogens in this category can infect healthy individuals, Dr. Kieny noted. “These infections, although not associated with significant mortality, have a dramatic health and economic impact on communities and, in particular, in low-income countries.”
Priority 3/”Medium” pathogens are Streptococcus pneumoniae, penicillin–non-susceptible; Haemophilus influenzae, ampicillin-resistant; and Shigella spp., fluoroquinolone-resistant.
These pathogens “represent a threat because of increasing resistance but still have some effective antibiotic options available,” Dr. Kieny said.
According to a statement provided by the WHO, the priority list doesn’t include streptococcus A and B or chlamydia, because resistance hasn’t reached the level of a public health threat.
One goal of the list is to focus attention on the development of small-market, gram-negative drugs that combat hospital-based infections, explained Nicola Magrini, MD, a WHO scientist who also spoke at the press conference.
Over the last decade, he said, the pipeline has instead focused more on gram-positive agents – mostly linked to beta-lactamase – that have wider market potential and generate less resistance.
“From a clinical point of view, these multidrug-resistant gram-negative clinical trials are very difficult and expensive to do, more than for gram-positive,” noted Evelina Tacconelli, MD, PhD, a contributor to the WHO report. “Because when we talk about gram-negative, we need to cover multiple pathogens and not just one or two, as in the case of gram-positive.”
Dr. Magrini said he couldn’t provide estimates about how many people worldwide are affected by the listed pathogens. However, he said a full report with numbers will be released by June.
It does appear that patients with severe infection from antibiotic-resistant germs face a mortality rate of up to 60%, while extended-spectrum beta-lactamase–positive E. coli accounts for up to 70% of urinary tract infections in many countries, explained Dr. Tacconelli, head of the division of infectious diseases at the University of Tübingen, Germany.
“Even if we don’t know exactly how many,” she said, “we are talking about millions of people affected.”
The World Health Organization is urging governments to focus antibiotic research efforts on a list of urgent bacterial threats, topped by several increasingly powerful superbugs that cause hospital-based infections and other potentially deadly conditions.
The WHO listed the top 20 bacteria that it believes are most harmful to human health, other than mycobacteria such as Mycobacterium tuberculosis, which causes tuberculosis. The germ was not included in the list because it’s generally accepted to be the most urgent priority for new antibiotic research and development, Marie-Paule Kieny, PhD, a WHO assistant director, said at a press conference.
The priority list is needed because the antibiotic pipeline is “practically dry,” thanks to scientific research challenges and a lack of financial incentives, according to Dr. Kieny. “Antibiotics are generally used for the short term, unlike therapies for chronic diseases, which bring in much higher returns on investment,” she said. The list “is intended to signal to the scientific community and the pharmaceutical industry the areas they should focus on to address urgent public health threats.”
The WHO list begins with Priority 1/“Critical” pathogens that it believes most urgently need to be targeted through antibiotic research and development: Acinetobacter baumannii, carbapenem-resistant; Pseudomonas aeruginosa, carbapenem-resistant; and Enterobacteriaceae (including Klebsiella pneumonia, Escherichia coli, Enterobacter spp., Serratia spp., Proteus spp., Providencia spp., and Morganella spp.), carbapenem-resistant, extended-spectrum beta-lactamase–producing.
“These bacteria are responsible for severe infections and high mortality rates, mostly in hospitalized patients, transplant recipients, those receiving chemotherapy, or patients in intensive care units,” Dr. Kieny said. “While these bacteria are not widespread and do not generally affect healthy individuals, the burden for patients and society is now alarming – and new, effective therapies are imperative.”
Priority 2/”High” pathogens are Enterococcus faecium, vancomycin-resistant; Staphylococcus aureus, methicillin-resistant, vancomycin intermediate and resistant; Helicobacter pylori, clarithromycin-resistant; Campylobacter, fluoroquinolone-resistant; Salmonella spp., fluoroquinolone-resistant; Neisseria gonorrhoeae, third-generation cephalosporin-resistant and fluoroquinolone-resistant.
Pathogens in this category can infect healthy individuals, Dr. Kieny noted. “These infections, although not associated with significant mortality, have a dramatic health and economic impact on communities and, in particular, in low-income countries.”
Priority 3/”Medium” pathogens are Streptococcus pneumoniae, penicillin–non-susceptible; Haemophilus influenzae, ampicillin-resistant; and Shigella spp., fluoroquinolone-resistant.
These pathogens “represent a threat because of increasing resistance but still have some effective antibiotic options available,” Dr. Kieny said.
According to a statement provided by the WHO, the priority list doesn’t include streptococcus A and B or chlamydia, because resistance hasn’t reached the level of a public health threat.
One goal of the list is to focus attention on the development of small-market, gram-negative drugs that combat hospital-based infections, explained Nicola Magrini, MD, a WHO scientist who also spoke at the press conference.
Over the last decade, he said, the pipeline has instead focused more on gram-positive agents – mostly linked to beta-lactamase – that have wider market potential and generate less resistance.
“From a clinical point of view, these multidrug-resistant gram-negative clinical trials are very difficult and expensive to do, more than for gram-positive,” noted Evelina Tacconelli, MD, PhD, a contributor to the WHO report. “Because when we talk about gram-negative, we need to cover multiple pathogens and not just one or two, as in the case of gram-positive.”
Dr. Magrini said he couldn’t provide estimates about how many people worldwide are affected by the listed pathogens. However, he said a full report with numbers will be released by June.
It does appear that patients with severe infection from antibiotic-resistant germs face a mortality rate of up to 60%, while extended-spectrum beta-lactamase–positive E. coli accounts for up to 70% of urinary tract infections in many countries, explained Dr. Tacconelli, head of the division of infectious diseases at the University of Tübingen, Germany.
“Even if we don’t know exactly how many,” she said, “we are talking about millions of people affected.”
The World Health Organization is urging governments to focus antibiotic research efforts on a list of urgent bacterial threats, topped by several increasingly powerful superbugs that cause hospital-based infections and other potentially deadly conditions.
The WHO listed the top 20 bacteria that it believes are most harmful to human health, other than mycobacteria such as Mycobacterium tuberculosis, which causes tuberculosis. The germ was not included in the list because it’s generally accepted to be the most urgent priority for new antibiotic research and development, Marie-Paule Kieny, PhD, a WHO assistant director, said at a press conference.
The priority list is needed because the antibiotic pipeline is “practically dry,” thanks to scientific research challenges and a lack of financial incentives, according to Dr. Kieny. “Antibiotics are generally used for the short term, unlike therapies for chronic diseases, which bring in much higher returns on investment,” she said. The list “is intended to signal to the scientific community and the pharmaceutical industry the areas they should focus on to address urgent public health threats.”
The WHO list begins with Priority 1/“Critical” pathogens that it believes most urgently need to be targeted through antibiotic research and development: Acinetobacter baumannii, carbapenem-resistant; Pseudomonas aeruginosa, carbapenem-resistant; and Enterobacteriaceae (including Klebsiella pneumonia, Escherichia coli, Enterobacter spp., Serratia spp., Proteus spp., Providencia spp., and Morganella spp.), carbapenem-resistant, extended-spectrum beta-lactamase–producing.
“These bacteria are responsible for severe infections and high mortality rates, mostly in hospitalized patients, transplant recipients, those receiving chemotherapy, or patients in intensive care units,” Dr. Kieny said. “While these bacteria are not widespread and do not generally affect healthy individuals, the burden for patients and society is now alarming – and new, effective therapies are imperative.”
Priority 2/”High” pathogens are Enterococcus faecium, vancomycin-resistant; Staphylococcus aureus, methicillin-resistant, vancomycin intermediate and resistant; Helicobacter pylori, clarithromycin-resistant; Campylobacter, fluoroquinolone-resistant; Salmonella spp., fluoroquinolone-resistant; Neisseria gonorrhoeae, third-generation cephalosporin-resistant and fluoroquinolone-resistant.
Pathogens in this category can infect healthy individuals, Dr. Kieny noted. “These infections, although not associated with significant mortality, have a dramatic health and economic impact on communities and, in particular, in low-income countries.”
Priority 3/”Medium” pathogens are Streptococcus pneumoniae, penicillin–non-susceptible; Haemophilus influenzae, ampicillin-resistant; and Shigella spp., fluoroquinolone-resistant.
These pathogens “represent a threat because of increasing resistance but still have some effective antibiotic options available,” Dr. Kieny said.
According to a statement provided by the WHO, the priority list doesn’t include streptococcus A and B or chlamydia, because resistance hasn’t reached the level of a public health threat.
One goal of the list is to focus attention on the development of small-market, gram-negative drugs that combat hospital-based infections, explained Nicola Magrini, MD, a WHO scientist who also spoke at the press conference.
Over the last decade, he said, the pipeline has instead focused more on gram-positive agents – mostly linked to beta-lactamase – that have wider market potential and generate less resistance.
“From a clinical point of view, these multidrug-resistant gram-negative clinical trials are very difficult and expensive to do, more than for gram-positive,” noted Evelina Tacconelli, MD, PhD, a contributor to the WHO report. “Because when we talk about gram-negative, we need to cover multiple pathogens and not just one or two, as in the case of gram-positive.”
Dr. Magrini said he couldn’t provide estimates about how many people worldwide are affected by the listed pathogens. However, he said a full report with numbers will be released by June.
It does appear that patients with severe infection from antibiotic-resistant germs face a mortality rate of up to 60%, while extended-spectrum beta-lactamase–positive E. coli accounts for up to 70% of urinary tract infections in many countries, explained Dr. Tacconelli, head of the division of infectious diseases at the University of Tübingen, Germany.
“Even if we don’t know exactly how many,” she said, “we are talking about millions of people affected.”
How to reduce the open hysterectomy rate
SAN ANTONIO – About a decade ago, the Northern California Permanente Medical Group realized it had a problem: There were too many open hysterectomies being performed.
“We had a large number of low-volume surgeons doing a lot of open hysterectomies,” said Andrew Walter, MD, a gynecologic surgeon at the Permanente Medical Group (TPMG) campus in Roseville, Calif., part of Kaiser Permanente. Across 15 hospitals in the system, “our open rate was 64% in 2007.”
To address the problem, “our leadership basically set targets; we then provided surgical education and training in minimally invasive hysterectomy,” Dr. Walter said at the annual scientific meeting of the Society of Gynecologic Surgeons.
Kaiser Permanente is a capitated system, but even so, its experience in reducing open hysterectomy rates may be useful for other systems dealing with the same problem.
At first, Dr. Walter and his colleagues didn’t know how much of an improvement could be made. “In 2008, we said, ‘Okay, 60% seems doable’” as a minimally invasive target rate, Dr. Walter said. TPMG hit that target, and “the chiefs looked at the numbers and said we can do a little bit better.” With some more effort, the rate of minimally invasive hysterectomies hit 80%, and then 90%, about where it stands today, with a corresponding drop in open rates.
“It will be interesting to see if someone says, ‘Let’s try 95%,’ ” Dr. Walter said.
However, the process hasn’t been easy, and it hasn’t been entirely evidence based, he said. “We are working with hundreds of gynecologists, and very few of them have had advanced training. But ultimately, it worked.”
Surgeons trained with TPMG peers experienced in minimally invasive hysterectomy, and both surgeons were kept on full salary during the learning process. It took about 5-15 cases before learner surgeons were considered proficient. “Funded proctoring is the most important aspect of the program,” he said.
TPMG also reduced the number of physicians doing hysterectomies from 416 to 228 in 2015. “This was the hard part, deciding who is a surgeon and who is not,” Dr. Walter said. “I would like to tell you that these were Kumbaya moments, but there was consternation, and there remains consternation about the process.” A number of ob.gyns. voluntarily gave up their surgical privileges, saying, ‘Thank God I don’t have to operate anymore,’ ” he said.
For low-volume surgeons – those who performed 10 or fewer hysterectomies a year – who wanted stay in the operating room, “we either had to push them into this training or encourage them to give up their surgical practices.” The more than 3,600 hysterectomies performed annually at TPMG facilities are now mostly done by surgeons doing at least 11 of these procedures a year, and often more than 20.
TPMG also paid for training courses at outside institutions, and department chiefs were held accountable for performance.
“Obviously, there are unique processes within Kaiser Permanente that facilitated this, but some of them are not unique. Physician support by enhanced training – that’s something that can be done. The barriers are reimbursement, and deciding who is a surgeon,” he said.
The next target is vaginal hysterectomy. Rates have been stable lately at about 30%, but “we have found that many patients, when reviewed, are vaginal hysterectomy candidates. We’ve set a target of 40%.” The procedure needs to be incentivized, Dr. Walter said, but it’s unclear how to do that at this point.
Dr. Walter reported having no relevant financial disclosures.
* The meeting sponsor information was updated 6/9/2017.
SAN ANTONIO – About a decade ago, the Northern California Permanente Medical Group realized it had a problem: There were too many open hysterectomies being performed.
“We had a large number of low-volume surgeons doing a lot of open hysterectomies,” said Andrew Walter, MD, a gynecologic surgeon at the Permanente Medical Group (TPMG) campus in Roseville, Calif., part of Kaiser Permanente. Across 15 hospitals in the system, “our open rate was 64% in 2007.”
To address the problem, “our leadership basically set targets; we then provided surgical education and training in minimally invasive hysterectomy,” Dr. Walter said at the annual scientific meeting of the Society of Gynecologic Surgeons.
Kaiser Permanente is a capitated system, but even so, its experience in reducing open hysterectomy rates may be useful for other systems dealing with the same problem.
At first, Dr. Walter and his colleagues didn’t know how much of an improvement could be made. “In 2008, we said, ‘Okay, 60% seems doable’” as a minimally invasive target rate, Dr. Walter said. TPMG hit that target, and “the chiefs looked at the numbers and said we can do a little bit better.” With some more effort, the rate of minimally invasive hysterectomies hit 80%, and then 90%, about where it stands today, with a corresponding drop in open rates.
“It will be interesting to see if someone says, ‘Let’s try 95%,’ ” Dr. Walter said.
However, the process hasn’t been easy, and it hasn’t been entirely evidence based, he said. “We are working with hundreds of gynecologists, and very few of them have had advanced training. But ultimately, it worked.”
Surgeons trained with TPMG peers experienced in minimally invasive hysterectomy, and both surgeons were kept on full salary during the learning process. It took about 5-15 cases before learner surgeons were considered proficient. “Funded proctoring is the most important aspect of the program,” he said.
TPMG also reduced the number of physicians doing hysterectomies from 416 to 228 in 2015. “This was the hard part, deciding who is a surgeon and who is not,” Dr. Walter said. “I would like to tell you that these were Kumbaya moments, but there was consternation, and there remains consternation about the process.” A number of ob.gyns. voluntarily gave up their surgical privileges, saying, ‘Thank God I don’t have to operate anymore,’ ” he said.
For low-volume surgeons – those who performed 10 or fewer hysterectomies a year – who wanted stay in the operating room, “we either had to push them into this training or encourage them to give up their surgical practices.” The more than 3,600 hysterectomies performed annually at TPMG facilities are now mostly done by surgeons doing at least 11 of these procedures a year, and often more than 20.
TPMG also paid for training courses at outside institutions, and department chiefs were held accountable for performance.
“Obviously, there are unique processes within Kaiser Permanente that facilitated this, but some of them are not unique. Physician support by enhanced training – that’s something that can be done. The barriers are reimbursement, and deciding who is a surgeon,” he said.
The next target is vaginal hysterectomy. Rates have been stable lately at about 30%, but “we have found that many patients, when reviewed, are vaginal hysterectomy candidates. We’ve set a target of 40%.” The procedure needs to be incentivized, Dr. Walter said, but it’s unclear how to do that at this point.
Dr. Walter reported having no relevant financial disclosures.
* The meeting sponsor information was updated 6/9/2017.
SAN ANTONIO – About a decade ago, the Northern California Permanente Medical Group realized it had a problem: There were too many open hysterectomies being performed.
“We had a large number of low-volume surgeons doing a lot of open hysterectomies,” said Andrew Walter, MD, a gynecologic surgeon at the Permanente Medical Group (TPMG) campus in Roseville, Calif., part of Kaiser Permanente. Across 15 hospitals in the system, “our open rate was 64% in 2007.”
To address the problem, “our leadership basically set targets; we then provided surgical education and training in minimally invasive hysterectomy,” Dr. Walter said at the annual scientific meeting of the Society of Gynecologic Surgeons.
Kaiser Permanente is a capitated system, but even so, its experience in reducing open hysterectomy rates may be useful for other systems dealing with the same problem.
At first, Dr. Walter and his colleagues didn’t know how much of an improvement could be made. “In 2008, we said, ‘Okay, 60% seems doable’” as a minimally invasive target rate, Dr. Walter said. TPMG hit that target, and “the chiefs looked at the numbers and said we can do a little bit better.” With some more effort, the rate of minimally invasive hysterectomies hit 80%, and then 90%, about where it stands today, with a corresponding drop in open rates.
“It will be interesting to see if someone says, ‘Let’s try 95%,’ ” Dr. Walter said.
However, the process hasn’t been easy, and it hasn’t been entirely evidence based, he said. “We are working with hundreds of gynecologists, and very few of them have had advanced training. But ultimately, it worked.”
Surgeons trained with TPMG peers experienced in minimally invasive hysterectomy, and both surgeons were kept on full salary during the learning process. It took about 5-15 cases before learner surgeons were considered proficient. “Funded proctoring is the most important aspect of the program,” he said.
TPMG also reduced the number of physicians doing hysterectomies from 416 to 228 in 2015. “This was the hard part, deciding who is a surgeon and who is not,” Dr. Walter said. “I would like to tell you that these were Kumbaya moments, but there was consternation, and there remains consternation about the process.” A number of ob.gyns. voluntarily gave up their surgical privileges, saying, ‘Thank God I don’t have to operate anymore,’ ” he said.
For low-volume surgeons – those who performed 10 or fewer hysterectomies a year – who wanted stay in the operating room, “we either had to push them into this training or encourage them to give up their surgical practices.” The more than 3,600 hysterectomies performed annually at TPMG facilities are now mostly done by surgeons doing at least 11 of these procedures a year, and often more than 20.
TPMG also paid for training courses at outside institutions, and department chiefs were held accountable for performance.
“Obviously, there are unique processes within Kaiser Permanente that facilitated this, but some of them are not unique. Physician support by enhanced training – that’s something that can be done. The barriers are reimbursement, and deciding who is a surgeon,” he said.
The next target is vaginal hysterectomy. Rates have been stable lately at about 30%, but “we have found that many patients, when reviewed, are vaginal hysterectomy candidates. We’ve set a target of 40%.” The procedure needs to be incentivized, Dr. Walter said, but it’s unclear how to do that at this point.
Dr. Walter reported having no relevant financial disclosures.
* The meeting sponsor information was updated 6/9/2017.
EXPERT ANALYSIS FROM SGS 2017
Series supports viability of ambulatory laparoscopic sleeve gastrectomy
HOUSTON – An ambulatory approach to laparoscopic sleeve gastrectomy is a safe and viable option to improve patient satisfaction and soften the economic blow of these procedures on patients, based on a large series at one surgery center in Cincinnati.
“With proper patient selection, utilization of enhanced recovery pathways with an overall low readmission rate and the complication profile point to the feasibility of laparoscopic sleeve gastrectomy [LSG] as a safe outpatient procedure,” said Sepehr Lalezari, MD, now a surgical fellow at Johns Hopkins University, Baltimore.
About 105,000 LSG operations were performed in the United States in 2015, representing 54% of all bariatric operations, according to the American Society for Metabolic and Bariatric Surgery.
Patient selection and strict adherence to protocols are keys to success for ambulatory LSG, Dr. Lalezari said. Suitable patients were found to be ambulatory, between ages 18 and 65 years; had a body mass index (BMI) less than 55 kg/m2 for males and less than 60 kg/m2 for females; weighed less than 500 lb; had an American Society of Anesthesiologists’ classification score less than 4; and had no significant cardiopulmonary impairment, had no history of renal failure or organ transplant, and were not on a transplant wait list.
In this series, 71% of patients (579) were female, and the average BMI was 43. The total complication rate was 2.3% (19); 17 of these patients required hospital admission.
Postoperative complications included gastric leaks (seven, 0.9%); intra-abdominal abscess requiring percutaneous drainage (four, 0.5%); dehydration, nausea, and/or vomiting (four, 0.5%); and one of each of the following: acute cholecystitis, postoperative bleeding, surgical site infection (SSI), and portal vein thrombosis/pulmonary embolism.
The two complications managed on an outpatient basis were the SSI and one intra-abdominal abscess, Dr. Lalezari said.
“The only readmissions in our series that could have been possibly prevented with an overnight stay in the hospital were the four cases of nausea, vomiting, and/or dehydration,” he said. “These only accounted for 0.5% of the total cases performed.”
The readmission rates for ambulatory LSG in this series compared favorably with large trials that did not distinguish between ambulatory and inpatient LSG procedures, Dr. Lalezari noted. A 2016 analysis of 35,655 patients in the American College of Surgeons National Surgical Quality Improvement Program database reported a readmission rate of 3.7% for LSG (Surg Endosc. 2016 Jun;30[6]:2342-50).
A larger study of 130,000 patients who had bariatric surgery reported an LSG readmission rate of 2.8% (Ann Surg. 2016 Nov 15. doi: 10.1097/SLA.0000000000002079). The most common cause for readmissions these trials reported were nausea, vomiting, and/or dehydration.
Bariatric surgeons have embraced enhanced recovery pathways and fast-track surgery, with good results, Dr. Lalezari said, citing work by Zhamak Khorgami, MD, and colleagues at the Cleveland Clinic (Surg Obes Relat Dis. 2017 Feb;13[2]:273-80).
“Looking at fast-track surgery, they found that patients discharged on postoperative day 1 vs. day 2 or 3 did not change outcomes”; those discharged later than postoperative day 1 trended toward a higher readmission rate of 2.8% vs. 3.6%, Dr. Lalezari said.
The enhanced recovery/fast track protocol Dr. Lalezari and his coauthors used involves placing intravenous lines and infusing 1 L crystalloid before starting the procedure, and administration of famotidine and metoclopramide prior to anesthesia. The protocol utilizes sequential compression devices and avoids Foley catheters and intra-abdominal drains. Patients receive dexamethasone and ondansetron during the operation. The protocol emphasizes early ambulation and resumption of oral intake.
The operation uses a 36-French bougie starting about 5 cm from the pylorus, and all staple lines are reinforced with buttress material. At the end of the surgery, all incisions are infiltrated with 30 cc of 0.5% bupivacaine with epinephrine.
Patients are ambulating about 90 minutes after surgery and are monitored for 3-4 hours. They receive a total volume of 3-4 L crystalloids. When they’re tolerating clear liquids, voiding spontaneously, and walking independently, and their pain is well controlled (pain score less than 5/10) and vital signs are within normal limits, they’re discharged.
Postoperative follow-up involves a call at 48 hours and in-clinic follow-up at weeks 1 and 4. Additional follow-up is scheduled at 3-month intervals for 1 year, then at 6 months for up to 2 years, and then yearly afterward.
“With proper patient selection and utilization of enhanced recovery pathways, the low overall readmission rate (2.1%) and complication profile (2.3%) in our series point to the feasibility of laparoscopic sleeve gastrectomy as a safe outpatient procedure,” Dr. Lalezari said.
He reported having no relevant financial disclosures.
HOUSTON – An ambulatory approach to laparoscopic sleeve gastrectomy is a safe and viable option to improve patient satisfaction and soften the economic blow of these procedures on patients, based on a large series at one surgery center in Cincinnati.
“With proper patient selection, utilization of enhanced recovery pathways with an overall low readmission rate and the complication profile point to the feasibility of laparoscopic sleeve gastrectomy [LSG] as a safe outpatient procedure,” said Sepehr Lalezari, MD, now a surgical fellow at Johns Hopkins University, Baltimore.
About 105,000 LSG operations were performed in the United States in 2015, representing 54% of all bariatric operations, according to the American Society for Metabolic and Bariatric Surgery.
Patient selection and strict adherence to protocols are keys to success for ambulatory LSG, Dr. Lalezari said. Suitable patients were found to be ambulatory, between ages 18 and 65 years; had a body mass index (BMI) less than 55 kg/m2 for males and less than 60 kg/m2 for females; weighed less than 500 lb; had an American Society of Anesthesiologists’ classification score less than 4; and had no significant cardiopulmonary impairment, had no history of renal failure or organ transplant, and were not on a transplant wait list.
In this series, 71% of patients (579) were female, and the average BMI was 43. The total complication rate was 2.3% (19); 17 of these patients required hospital admission.
Postoperative complications included gastric leaks (seven, 0.9%); intra-abdominal abscess requiring percutaneous drainage (four, 0.5%); dehydration, nausea, and/or vomiting (four, 0.5%); and one of each of the following: acute cholecystitis, postoperative bleeding, surgical site infection (SSI), and portal vein thrombosis/pulmonary embolism.
The two complications managed on an outpatient basis were the SSI and one intra-abdominal abscess, Dr. Lalezari said.
“The only readmissions in our series that could have been possibly prevented with an overnight stay in the hospital were the four cases of nausea, vomiting, and/or dehydration,” he said. “These only accounted for 0.5% of the total cases performed.”
The readmission rates for ambulatory LSG in this series compared favorably with large trials that did not distinguish between ambulatory and inpatient LSG procedures, Dr. Lalezari noted. A 2016 analysis of 35,655 patients in the American College of Surgeons National Surgical Quality Improvement Program database reported a readmission rate of 3.7% for LSG (Surg Endosc. 2016 Jun;30[6]:2342-50).
A larger study of 130,000 patients who had bariatric surgery reported an LSG readmission rate of 2.8% (Ann Surg. 2016 Nov 15. doi: 10.1097/SLA.0000000000002079). The most common cause for readmissions these trials reported were nausea, vomiting, and/or dehydration.
Bariatric surgeons have embraced enhanced recovery pathways and fast-track surgery, with good results, Dr. Lalezari said, citing work by Zhamak Khorgami, MD, and colleagues at the Cleveland Clinic (Surg Obes Relat Dis. 2017 Feb;13[2]:273-80).
“Looking at fast-track surgery, they found that patients discharged on postoperative day 1 vs. day 2 or 3 did not change outcomes”; those discharged later than postoperative day 1 trended toward a higher readmission rate of 2.8% vs. 3.6%, Dr. Lalezari said.
The enhanced recovery/fast track protocol Dr. Lalezari and his coauthors used involves placing intravenous lines and infusing 1 L crystalloid before starting the procedure, and administration of famotidine and metoclopramide prior to anesthesia. The protocol utilizes sequential compression devices and avoids Foley catheters and intra-abdominal drains. Patients receive dexamethasone and ondansetron during the operation. The protocol emphasizes early ambulation and resumption of oral intake.
The operation uses a 36-French bougie starting about 5 cm from the pylorus, and all staple lines are reinforced with buttress material. At the end of the surgery, all incisions are infiltrated with 30 cc of 0.5% bupivacaine with epinephrine.
Patients are ambulating about 90 minutes after surgery and are monitored for 3-4 hours. They receive a total volume of 3-4 L crystalloids. When they’re tolerating clear liquids, voiding spontaneously, and walking independently, and their pain is well controlled (pain score less than 5/10) and vital signs are within normal limits, they’re discharged.
Postoperative follow-up involves a call at 48 hours and in-clinic follow-up at weeks 1 and 4. Additional follow-up is scheduled at 3-month intervals for 1 year, then at 6 months for up to 2 years, and then yearly afterward.
“With proper patient selection and utilization of enhanced recovery pathways, the low overall readmission rate (2.1%) and complication profile (2.3%) in our series point to the feasibility of laparoscopic sleeve gastrectomy as a safe outpatient procedure,” Dr. Lalezari said.
He reported having no relevant financial disclosures.
HOUSTON – An ambulatory approach to laparoscopic sleeve gastrectomy is a safe and viable option to improve patient satisfaction and soften the economic blow of these procedures on patients, based on a large series at one surgery center in Cincinnati.
“With proper patient selection, utilization of enhanced recovery pathways with an overall low readmission rate and the complication profile point to the feasibility of laparoscopic sleeve gastrectomy [LSG] as a safe outpatient procedure,” said Sepehr Lalezari, MD, now a surgical fellow at Johns Hopkins University, Baltimore.
About 105,000 LSG operations were performed in the United States in 2015, representing 54% of all bariatric operations, according to the American Society for Metabolic and Bariatric Surgery.
Patient selection and strict adherence to protocols are keys to success for ambulatory LSG, Dr. Lalezari said. Suitable patients were found to be ambulatory, between ages 18 and 65 years; had a body mass index (BMI) less than 55 kg/m2 for males and less than 60 kg/m2 for females; weighed less than 500 lb; had an American Society of Anesthesiologists’ classification score less than 4; and had no significant cardiopulmonary impairment, had no history of renal failure or organ transplant, and were not on a transplant wait list.
In this series, 71% of patients (579) were female, and the average BMI was 43. The total complication rate was 2.3% (19); 17 of these patients required hospital admission.
Postoperative complications included gastric leaks (seven, 0.9%); intra-abdominal abscess requiring percutaneous drainage (four, 0.5%); dehydration, nausea, and/or vomiting (four, 0.5%); and one of each of the following: acute cholecystitis, postoperative bleeding, surgical site infection (SSI), and portal vein thrombosis/pulmonary embolism.
The two complications managed on an outpatient basis were the SSI and one intra-abdominal abscess, Dr. Lalezari said.
“The only readmissions in our series that could have been possibly prevented with an overnight stay in the hospital were the four cases of nausea, vomiting, and/or dehydration,” he said. “These only accounted for 0.5% of the total cases performed.”
The readmission rates for ambulatory LSG in this series compared favorably with large trials that did not distinguish between ambulatory and inpatient LSG procedures, Dr. Lalezari noted. A 2016 analysis of 35,655 patients in the American College of Surgeons National Surgical Quality Improvement Program database reported a readmission rate of 3.7% for LSG (Surg Endosc. 2016 Jun;30[6]:2342-50).
A larger study of 130,000 patients who had bariatric surgery reported an LSG readmission rate of 2.8% (Ann Surg. 2016 Nov 15. doi: 10.1097/SLA.0000000000002079). The most common cause for readmissions these trials reported were nausea, vomiting, and/or dehydration.
Bariatric surgeons have embraced enhanced recovery pathways and fast-track surgery, with good results, Dr. Lalezari said, citing work by Zhamak Khorgami, MD, and colleagues at the Cleveland Clinic (Surg Obes Relat Dis. 2017 Feb;13[2]:273-80).
“Looking at fast-track surgery, they found that patients discharged on postoperative day 1 vs. day 2 or 3 did not change outcomes”; those discharged later than postoperative day 1 trended toward a higher readmission rate of 2.8% vs. 3.6%, Dr. Lalezari said.
The enhanced recovery/fast track protocol Dr. Lalezari and his coauthors used involves placing intravenous lines and infusing 1 L crystalloid before starting the procedure, and administration of famotidine and metoclopramide prior to anesthesia. The protocol utilizes sequential compression devices and avoids Foley catheters and intra-abdominal drains. Patients receive dexamethasone and ondansetron during the operation. The protocol emphasizes early ambulation and resumption of oral intake.
The operation uses a 36-French bougie starting about 5 cm from the pylorus, and all staple lines are reinforced with buttress material. At the end of the surgery, all incisions are infiltrated with 30 cc of 0.5% bupivacaine with epinephrine.
Patients are ambulating about 90 minutes after surgery and are monitored for 3-4 hours. They receive a total volume of 3-4 L crystalloids. When they’re tolerating clear liquids, voiding spontaneously, and walking independently, and their pain is well controlled (pain score less than 5/10) and vital signs are within normal limits, they’re discharged.
Postoperative follow-up involves a call at 48 hours and in-clinic follow-up at weeks 1 and 4. Additional follow-up is scheduled at 3-month intervals for 1 year, then at 6 months for up to 2 years, and then yearly afterward.
“With proper patient selection and utilization of enhanced recovery pathways, the low overall readmission rate (2.1%) and complication profile (2.3%) in our series point to the feasibility of laparoscopic sleeve gastrectomy as a safe outpatient procedure,” Dr. Lalezari said.
He reported having no relevant financial disclosures.
AT SAGES 2017
Key clinical point: Laparoscopic sleeve gastrectomy is a safe outpatient procedure – with strict adherence to enhanced recovery pathways and fast-track protocols.
Major finding: This series reported an overall readmission rate of 2.1% and a complication rate of 2.3% in patients who had outpatient LSG.
Data source: A retrospective review of 821 patients who had ambulatory LSG by a single surgeon from 2011 to 2015.
Disclosures: Dr. Lalezari reported having no relevant financial disclosures.
High readmits after peripheral arterial procedures
WASHINGTON – More than one in six patients who undergo a lower extremity arterial endovascular or surgical procedure are readmitted within 30 days, according to a large national study.
The annual total cost of these early readmissions is high, in excess of $360 million. But because there turned out to be surprisingly little difference in readmission rates between hospitals, 30-day readmissions may not be a rational quality measure on which to base institutional reimbursement or withholding of payment for peripheral arterial interventions, Eric A. Secemsky, MD, said at the annual meeting of the American College of Cardiology.
Forty-seven percent of patients had an endovascular procedure, 42% had surgery, and the remainder had hybrid procedures in which both endovascular and surgical interventions took place during the same admission. Patients with hybrid procedures contributed data to both treatment groups.
In-hospital mortality occurred in 2.5% of patients.
Of the patients who survived to discharge, 21,589, or 17.4%, were readmitted within 30 days. The early readmission rate was higher following endovascular procedures, at 18.7%, than the 16.1% rate in the surgical group. The average cost of a readmission was $15,876. Death during readmission occurred in 4.2% of patients.
The median rate ratio – a measure of the amount of variance in readmission rates between hospitals – was 1.12. That’s a low figure.
“If the median rate ratio is lower, like here, it says there’s not a lot of interhospital variability across the country. So overall this burden seems to be pretty uniform across the institutions included in our analysis,” Dr. Secemsky explained.
This observation drew the attention of session comoderator Naomi M. Hamburg, MD.
“It’s interesting that you didn’t see a lot of heterogeneity across hospitals, because we often think of readmissions as a potentially modifiable quality metric. Do you think it’s modifiable, or is this just the nature of the disease?” asked Dr. Hamburg of Boston Medical Center.
It’s the disease process, Dr. Secemsky replied.
“We were surprised by the lack of hospital variation,” he added. None of the institutional characteristics examined, including teaching hospital status, bed size, and procedural volume, had a significant impact on readmission rates.
But that doesn’t mean there aren’t opportunities to whittle down those readmissions, according to Dr. Secemsky.
He noted that the high readmission rates were driven by procedural complications such as graft or stent failure. Indeed, procedural complications accounted for 29% of all early readmissions. The procedural complication rate was about 20% following endovascular procedures and 39% after surgery. It’s likely that identification and implementation of best practices could trim those high rates. Unfortunately, however, the nationwide database relies upon ICD-9 codes, which don’t provide the granular level of detail required to home in on specific best practices. That will require further studies, according to Dr. Secemsky.
A distant second on the list of causes of early readmission was peripheral atherosclerosis, meaning persistent claudication or rest pain. This accounted for 8.8% of readmissions. Rounding out the top five causes of readmission were sepsis, which was the reason for 6.7% of readmissions; diabetes with complications, at 4.7%; and heart failure, at 4.6%.
The strongest predictors of readmission included having renal disease at baseline, Medicare rather than private insurance, and discharge to a subacute nursing facility or home with home care.
Dr. Hamburg commented that a focus on reducing readmissions for sepsis as well as for skin and soft tissue infections, which accounted for 2.1% of 30-day hospitalizations, could be fruitful.
Dr. Secemsky reported having no financial conflicts regarding his study.
WASHINGTON – More than one in six patients who undergo a lower extremity arterial endovascular or surgical procedure are readmitted within 30 days, according to a large national study.
The annual total cost of these early readmissions is high, in excess of $360 million. But because there turned out to be surprisingly little difference in readmission rates between hospitals, 30-day readmissions may not be a rational quality measure on which to base institutional reimbursement or withholding of payment for peripheral arterial interventions, Eric A. Secemsky, MD, said at the annual meeting of the American College of Cardiology.
Forty-seven percent of patients had an endovascular procedure, 42% had surgery, and the remainder had hybrid procedures in which both endovascular and surgical interventions took place during the same admission. Patients with hybrid procedures contributed data to both treatment groups.
In-hospital mortality occurred in 2.5% of patients.
Of the patients who survived to discharge, 21,589, or 17.4%, were readmitted within 30 days. The early readmission rate was higher following endovascular procedures, at 18.7%, than the 16.1% rate in the surgical group. The average cost of a readmission was $15,876. Death during readmission occurred in 4.2% of patients.
The median rate ratio – a measure of the amount of variance in readmission rates between hospitals – was 1.12. That’s a low figure.
“If the median rate ratio is lower, like here, it says there’s not a lot of interhospital variability across the country. So overall this burden seems to be pretty uniform across the institutions included in our analysis,” Dr. Secemsky explained.
This observation drew the attention of session comoderator Naomi M. Hamburg, MD.
“It’s interesting that you didn’t see a lot of heterogeneity across hospitals, because we often think of readmissions as a potentially modifiable quality metric. Do you think it’s modifiable, or is this just the nature of the disease?” asked Dr. Hamburg of Boston Medical Center.
It’s the disease process, Dr. Secemsky replied.
“We were surprised by the lack of hospital variation,” he added. None of the institutional characteristics examined, including teaching hospital status, bed size, and procedural volume, had a significant impact on readmission rates.
But that doesn’t mean there aren’t opportunities to whittle down those readmissions, according to Dr. Secemsky.
He noted that the high readmission rates were driven by procedural complications such as graft or stent failure. Indeed, procedural complications accounted for 29% of all early readmissions. The procedural complication rate was about 20% following endovascular procedures and 39% after surgery. It’s likely that identification and implementation of best practices could trim those high rates. Unfortunately, however, the nationwide database relies upon ICD-9 codes, which don’t provide the granular level of detail required to home in on specific best practices. That will require further studies, according to Dr. Secemsky.
A distant second on the list of causes of early readmission was peripheral atherosclerosis, meaning persistent claudication or rest pain. This accounted for 8.8% of readmissions. Rounding out the top five causes of readmission were sepsis, which was the reason for 6.7% of readmissions; diabetes with complications, at 4.7%; and heart failure, at 4.6%.
The strongest predictors of readmission included having renal disease at baseline, Medicare rather than private insurance, and discharge to a subacute nursing facility or home with home care.
Dr. Hamburg commented that a focus on reducing readmissions for sepsis as well as for skin and soft tissue infections, which accounted for 2.1% of 30-day hospitalizations, could be fruitful.
Dr. Secemsky reported having no financial conflicts regarding his study.
WASHINGTON – More than one in six patients who undergo a lower extremity arterial endovascular or surgical procedure are readmitted within 30 days, according to a large national study.
The annual total cost of these early readmissions is high, in excess of $360 million. But because there turned out to be surprisingly little difference in readmission rates between hospitals, 30-day readmissions may not be a rational quality measure on which to base institutional reimbursement or withholding of payment for peripheral arterial interventions, Eric A. Secemsky, MD, said at the annual meeting of the American College of Cardiology.
Forty-seven percent of patients had an endovascular procedure, 42% had surgery, and the remainder had hybrid procedures in which both endovascular and surgical interventions took place during the same admission. Patients with hybrid procedures contributed data to both treatment groups.
In-hospital mortality occurred in 2.5% of patients.
Of the patients who survived to discharge, 21,589, or 17.4%, were readmitted within 30 days. The early readmission rate was higher following endovascular procedures, at 18.7%, than the 16.1% rate in the surgical group. The average cost of a readmission was $15,876. Death during readmission occurred in 4.2% of patients.
The median rate ratio – a measure of the amount of variance in readmission rates between hospitals – was 1.12. That’s a low figure.
“If the median rate ratio is lower, like here, it says there’s not a lot of interhospital variability across the country. So overall this burden seems to be pretty uniform across the institutions included in our analysis,” Dr. Secemsky explained.
This observation drew the attention of session comoderator Naomi M. Hamburg, MD.
“It’s interesting that you didn’t see a lot of heterogeneity across hospitals, because we often think of readmissions as a potentially modifiable quality metric. Do you think it’s modifiable, or is this just the nature of the disease?” asked Dr. Hamburg of Boston Medical Center.
It’s the disease process, Dr. Secemsky replied.
“We were surprised by the lack of hospital variation,” he added. None of the institutional characteristics examined, including teaching hospital status, bed size, and procedural volume, had a significant impact on readmission rates.
But that doesn’t mean there aren’t opportunities to whittle down those readmissions, according to Dr. Secemsky.
He noted that the high readmission rates were driven by procedural complications such as graft or stent failure. Indeed, procedural complications accounted for 29% of all early readmissions. The procedural complication rate was about 20% following endovascular procedures and 39% after surgery. It’s likely that identification and implementation of best practices could trim those high rates. Unfortunately, however, the nationwide database relies upon ICD-9 codes, which don’t provide the granular level of detail required to home in on specific best practices. That will require further studies, according to Dr. Secemsky.
A distant second on the list of causes of early readmission was peripheral atherosclerosis, meaning persistent claudication or rest pain. This accounted for 8.8% of readmissions. Rounding out the top five causes of readmission were sepsis, which was the reason for 6.7% of readmissions; diabetes with complications, at 4.7%; and heart failure, at 4.6%.
The strongest predictors of readmission included having renal disease at baseline, Medicare rather than private insurance, and discharge to a subacute nursing facility or home with home care.
Dr. Hamburg commented that a focus on reducing readmissions for sepsis as well as for skin and soft tissue infections, which accounted for 2.1% of 30-day hospitalizations, could be fruitful.
Dr. Secemsky reported having no financial conflicts regarding his study.
AT ACC 2017
Key clinical point:
Major finding: Readmission within 30 days after a peripheral arterial procedure occurred nationally in 17.4% of patients, with little between-hospital variation in rates.
Data source: A retrospective analysis of nearly 124,000 hospital admissions for lower extremity arterial endovascular or surgical procedures.
Disclosures: The study presenter reported having no financial conflicts of interest.
Drugmakers Dramatically Boosted Lobbying Spending In Trump’s First Quarter
Eight pharmaceutical companies more than doubled their lobbying spending in the first three months of 2017, when the Affordable Care Act was on the chopping block and high drug prices were clearly in the crosshairs of Congress and President Donald Trump.
Congressional records show that those eight, including Celgene and Mylan, kicked in an extra $4.42 million versus that quarter last year. Industry giant Teva Pharmaceutical Industries spent $2.67 million, up 115% from a year ago as several companies embroiled in controversies raised their outlays significantly.
“It’s certainly a rare event” when lobbying dollars double, noted Timothy LaPira, PhD, an associate professor of political science at James Madison University. “These spikes are usually timed when Congress in particular is going to be really hammering home on a particular issue. Right now, that’s health care and taxes.”
Trump has come down hard on drugmakers, stating in a press conference before his inauguration that the industry is “getting away with murder.” He has promised to lower drug prices and increase competition with faster approvals and fewer regulations. Sen. Bernie Sanders (I-Vt.), Sen. John McCain (R-Ariz.), and Rep. Elijah E. Cummings (D-Md.) have introduced bills to allow lower-cost drug imports from Canada or other countries.
Lobbyists weren’t expecting much by way of big policy changes during the comparatively sleepy end of the Obama administration this time last year, but, with a surprise Trump administration and a Republican-controlled House and Senate, trade groups and companies are probably “going all in,” Dr. LaPira said.
Thirty-eight major drugmakers and trade groups spent a total of $50.9 million, up $10.1 million from the first quarter of last year, according to a Kaiser Health News analysis. They deployed 600 lobbyists in all.
PhRMA, the drug industry’s largest trade group, spent $7.98 million during the quarter – more than in any single quarter in almost a decade, congressional records show, topping even its quarterly lobbying ahead of the Affordable Care Act’s passage in 2010.
In their congressional disclosures, companies listed Medicare price negotiation, the American Health Care Act, drug importation, and the orphan drug program as issues they were lobbying for or against. They do not have to disclose on which side of an issue they lobbied.
When Medicare prices are on the table, it should come as no surprise that pharmaceutical companies are interested in influencing congress.
“It’s quite literally hitting their bottom line,” LaPira said.
Drugmakers, under fire, more than doubled their lobbying dollars. Mylan spent $1.45 million during the quarter, up from $610,000 last year. The company’s CEO faced a congressional hearing in the fall when it raised the price of EpiPen to over $600.
Marathon Pharmaceuticals spent $230,000, which was $120,000 more than last year. Marathon was criticized in February after setting the price of Emflaza, a steroid to treat Duchenne muscular dystrophy, at $89,000 a year. That angered advocates, Congress, and patients who had been importing the same drug for as little as $1,000 a year. Marathon has since sold the drug to another company, and the price may come down.
Teva and Shire also more than doubled their spending. Teva was accused, as part of an alleged generic price-fixing scheme in December, and the Federal Trade Commission sued Shire because one of its recently acquired companies allegedly filed “sham” petitions with the Food and Drug Administration to stave off generics.
Companies that make drugs for rare diseases also more than doubled lobbying dollars as congressional leaders and the Government Accountability Office work to determine whether the Orphan Drug Act is being abused. Those firms include BioMarin, Celgene, and Vertex Pharmaceuticals. Celgene, which makes a rare cancer drug, more than tripled its first quarter lobbying to more than $1 million.
Despite efforts to make good on campaign promises to repeal the Affordable Care Act, House Republicans canceled a floor vote on the American Health Care Act in March after multiple studies estimated that millions of people would lose coverage if it passed, and neither Democrats nor ultraconservatives lined up in opposition to the bill’s provisions. Drug prices weren’t a key part of the package.
KHN’s coverage of prescription drug development, costs, and pricing is supported in part by the Laura and John Arnold Foundation. Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
Eight pharmaceutical companies more than doubled their lobbying spending in the first three months of 2017, when the Affordable Care Act was on the chopping block and high drug prices were clearly in the crosshairs of Congress and President Donald Trump.
Congressional records show that those eight, including Celgene and Mylan, kicked in an extra $4.42 million versus that quarter last year. Industry giant Teva Pharmaceutical Industries spent $2.67 million, up 115% from a year ago as several companies embroiled in controversies raised their outlays significantly.
“It’s certainly a rare event” when lobbying dollars double, noted Timothy LaPira, PhD, an associate professor of political science at James Madison University. “These spikes are usually timed when Congress in particular is going to be really hammering home on a particular issue. Right now, that’s health care and taxes.”
Trump has come down hard on drugmakers, stating in a press conference before his inauguration that the industry is “getting away with murder.” He has promised to lower drug prices and increase competition with faster approvals and fewer regulations. Sen. Bernie Sanders (I-Vt.), Sen. John McCain (R-Ariz.), and Rep. Elijah E. Cummings (D-Md.) have introduced bills to allow lower-cost drug imports from Canada or other countries.
Lobbyists weren’t expecting much by way of big policy changes during the comparatively sleepy end of the Obama administration this time last year, but, with a surprise Trump administration and a Republican-controlled House and Senate, trade groups and companies are probably “going all in,” Dr. LaPira said.
Thirty-eight major drugmakers and trade groups spent a total of $50.9 million, up $10.1 million from the first quarter of last year, according to a Kaiser Health News analysis. They deployed 600 lobbyists in all.
PhRMA, the drug industry’s largest trade group, spent $7.98 million during the quarter – more than in any single quarter in almost a decade, congressional records show, topping even its quarterly lobbying ahead of the Affordable Care Act’s passage in 2010.
In their congressional disclosures, companies listed Medicare price negotiation, the American Health Care Act, drug importation, and the orphan drug program as issues they were lobbying for or against. They do not have to disclose on which side of an issue they lobbied.
When Medicare prices are on the table, it should come as no surprise that pharmaceutical companies are interested in influencing congress.
“It’s quite literally hitting their bottom line,” LaPira said.
Drugmakers, under fire, more than doubled their lobbying dollars. Mylan spent $1.45 million during the quarter, up from $610,000 last year. The company’s CEO faced a congressional hearing in the fall when it raised the price of EpiPen to over $600.
Marathon Pharmaceuticals spent $230,000, which was $120,000 more than last year. Marathon was criticized in February after setting the price of Emflaza, a steroid to treat Duchenne muscular dystrophy, at $89,000 a year. That angered advocates, Congress, and patients who had been importing the same drug for as little as $1,000 a year. Marathon has since sold the drug to another company, and the price may come down.
Teva and Shire also more than doubled their spending. Teva was accused, as part of an alleged generic price-fixing scheme in December, and the Federal Trade Commission sued Shire because one of its recently acquired companies allegedly filed “sham” petitions with the Food and Drug Administration to stave off generics.
Companies that make drugs for rare diseases also more than doubled lobbying dollars as congressional leaders and the Government Accountability Office work to determine whether the Orphan Drug Act is being abused. Those firms include BioMarin, Celgene, and Vertex Pharmaceuticals. Celgene, which makes a rare cancer drug, more than tripled its first quarter lobbying to more than $1 million.
Despite efforts to make good on campaign promises to repeal the Affordable Care Act, House Republicans canceled a floor vote on the American Health Care Act in March after multiple studies estimated that millions of people would lose coverage if it passed, and neither Democrats nor ultraconservatives lined up in opposition to the bill’s provisions. Drug prices weren’t a key part of the package.
KHN’s coverage of prescription drug development, costs, and pricing is supported in part by the Laura and John Arnold Foundation. Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
Eight pharmaceutical companies more than doubled their lobbying spending in the first three months of 2017, when the Affordable Care Act was on the chopping block and high drug prices were clearly in the crosshairs of Congress and President Donald Trump.
Congressional records show that those eight, including Celgene and Mylan, kicked in an extra $4.42 million versus that quarter last year. Industry giant Teva Pharmaceutical Industries spent $2.67 million, up 115% from a year ago as several companies embroiled in controversies raised their outlays significantly.
“It’s certainly a rare event” when lobbying dollars double, noted Timothy LaPira, PhD, an associate professor of political science at James Madison University. “These spikes are usually timed when Congress in particular is going to be really hammering home on a particular issue. Right now, that’s health care and taxes.”
Trump has come down hard on drugmakers, stating in a press conference before his inauguration that the industry is “getting away with murder.” He has promised to lower drug prices and increase competition with faster approvals and fewer regulations. Sen. Bernie Sanders (I-Vt.), Sen. John McCain (R-Ariz.), and Rep. Elijah E. Cummings (D-Md.) have introduced bills to allow lower-cost drug imports from Canada or other countries.
Lobbyists weren’t expecting much by way of big policy changes during the comparatively sleepy end of the Obama administration this time last year, but, with a surprise Trump administration and a Republican-controlled House and Senate, trade groups and companies are probably “going all in,” Dr. LaPira said.
Thirty-eight major drugmakers and trade groups spent a total of $50.9 million, up $10.1 million from the first quarter of last year, according to a Kaiser Health News analysis. They deployed 600 lobbyists in all.
PhRMA, the drug industry’s largest trade group, spent $7.98 million during the quarter – more than in any single quarter in almost a decade, congressional records show, topping even its quarterly lobbying ahead of the Affordable Care Act’s passage in 2010.
In their congressional disclosures, companies listed Medicare price negotiation, the American Health Care Act, drug importation, and the orphan drug program as issues they were lobbying for or against. They do not have to disclose on which side of an issue they lobbied.
When Medicare prices are on the table, it should come as no surprise that pharmaceutical companies are interested in influencing congress.
“It’s quite literally hitting their bottom line,” LaPira said.
Drugmakers, under fire, more than doubled their lobbying dollars. Mylan spent $1.45 million during the quarter, up from $610,000 last year. The company’s CEO faced a congressional hearing in the fall when it raised the price of EpiPen to over $600.
Marathon Pharmaceuticals spent $230,000, which was $120,000 more than last year. Marathon was criticized in February after setting the price of Emflaza, a steroid to treat Duchenne muscular dystrophy, at $89,000 a year. That angered advocates, Congress, and patients who had been importing the same drug for as little as $1,000 a year. Marathon has since sold the drug to another company, and the price may come down.
Teva and Shire also more than doubled their spending. Teva was accused, as part of an alleged generic price-fixing scheme in December, and the Federal Trade Commission sued Shire because one of its recently acquired companies allegedly filed “sham” petitions with the Food and Drug Administration to stave off generics.
Companies that make drugs for rare diseases also more than doubled lobbying dollars as congressional leaders and the Government Accountability Office work to determine whether the Orphan Drug Act is being abused. Those firms include BioMarin, Celgene, and Vertex Pharmaceuticals. Celgene, which makes a rare cancer drug, more than tripled its first quarter lobbying to more than $1 million.
Despite efforts to make good on campaign promises to repeal the Affordable Care Act, House Republicans canceled a floor vote on the American Health Care Act in March after multiple studies estimated that millions of people would lose coverage if it passed, and neither Democrats nor ultraconservatives lined up in opposition to the bill’s provisions. Drug prices weren’t a key part of the package.
KHN’s coverage of prescription drug development, costs, and pricing is supported in part by the Laura and John Arnold Foundation. Kaiser Health News is a national health policy news service that is part of the nonpartisan Henry J. Kaiser Family Foundation.
Blood donor age, sex do not affect recipient survival
The age and sex of blood donors do not affect the recipient’s survival and do not need to be considered in blood allocation, according to a report published online April 24 in JAMA Internal Medicine.
A recent observational Canadian study suggested that blood from young donors and female donors increased the recipients’ risk of death – a finding which, if confirmed, would have immediate implications for medical practice.
A separate group of Scandinavian researchers attempted to replicate these findings by performing a retrospective cohort study using similar but more nuanced statistical methods. Gustaf Edgren, MD, PhD, of the department of medical epidemiology and biostatistics, Karolinska Institutet, Stockholm, and his associates analyzed information collected on 968,264 patients over a 10-year period from a Swedish and Danish transfusion database.
In initial, unadjusted analyses, both extremes of age (young and old) and female sex in the donor were associated with reduced survival in the recipient. However, that association disappeared when the data were adjusted to account for the total number of transfusions a patient received, a marker of their severity of illness. The hazard ratio per transfusion from a donor younger than age 20 was 0.98, and the hazard ratio per transfusion from a female donor was 0.99. This pattern also occurred in sensitivity analyses, the investigators noted (JAMA Intern. Med. 2017 April 24. doi: 10.1001/jamainternmed.2017.0890).
“When studying associations between ... transfusions with a particular characteristic and the risk of death in the recipient, [the] underlying disease severity ... may still confound the association. However, with meticulous adjustment for total number of transfusions, it should be possible to block the confounding effect of patient disease severity entirely,” they noted.
“We believe that, rather than reflecting true biologic effects, the Canadian results can be explained by residual confounding (i.e., that the observations resulted from incomplete adjustment for the number of transfusions),” Dr. Edgren and his associates said.
“In addition, we believe these data reinforce the importance of extreme caution in assessing epidemiologic analyses in this field, given the tremendous clinical and logistical implications of false-positive findings,” they added.
The findings of Edgren et al. provide reassurance regarding the safety of current transfusion practice.
They present a convincing argument that differences in the statistical approach for controlling confounding likely explained the discrepant results of the Canadian study and their study.
This subtle confounding stems from the fact that increased transfusions expose the recipient to a greater total number of blood products, which in turn is associated with higher comorbidity, greater severity of illness, and higher mortality.
Nareg Roubinian, MD, is at the Blood Systems Research Institute, San Francisco, and in the division of research at Kaiser Permanente Northern California, Oakland. He and his associates reported having no relevant financial disclosures. They made these remarks in an invited commentary accompanying Dr. Edgren’s report (JAMA Intern. Med. 2017 April 24. doi: 10.1001/jamainternmed.2017.0914).
The findings of Edgren et al. provide reassurance regarding the safety of current transfusion practice.
They present a convincing argument that differences in the statistical approach for controlling confounding likely explained the discrepant results of the Canadian study and their study.
This subtle confounding stems from the fact that increased transfusions expose the recipient to a greater total number of blood products, which in turn is associated with higher comorbidity, greater severity of illness, and higher mortality.
Nareg Roubinian, MD, is at the Blood Systems Research Institute, San Francisco, and in the division of research at Kaiser Permanente Northern California, Oakland. He and his associates reported having no relevant financial disclosures. They made these remarks in an invited commentary accompanying Dr. Edgren’s report (JAMA Intern. Med. 2017 April 24. doi: 10.1001/jamainternmed.2017.0914).
The findings of Edgren et al. provide reassurance regarding the safety of current transfusion practice.
They present a convincing argument that differences in the statistical approach for controlling confounding likely explained the discrepant results of the Canadian study and their study.
This subtle confounding stems from the fact that increased transfusions expose the recipient to a greater total number of blood products, which in turn is associated with higher comorbidity, greater severity of illness, and higher mortality.
Nareg Roubinian, MD, is at the Blood Systems Research Institute, San Francisco, and in the division of research at Kaiser Permanente Northern California, Oakland. He and his associates reported having no relevant financial disclosures. They made these remarks in an invited commentary accompanying Dr. Edgren’s report (JAMA Intern. Med. 2017 April 24. doi: 10.1001/jamainternmed.2017.0914).
The age and sex of blood donors do not affect the recipient’s survival and do not need to be considered in blood allocation, according to a report published online April 24 in JAMA Internal Medicine.
A recent observational Canadian study suggested that blood from young donors and female donors increased the recipients’ risk of death – a finding which, if confirmed, would have immediate implications for medical practice.
A separate group of Scandinavian researchers attempted to replicate these findings by performing a retrospective cohort study using similar but more nuanced statistical methods. Gustaf Edgren, MD, PhD, of the department of medical epidemiology and biostatistics, Karolinska Institutet, Stockholm, and his associates analyzed information collected on 968,264 patients over a 10-year period from a Swedish and Danish transfusion database.
In initial, unadjusted analyses, both extremes of age (young and old) and female sex in the donor were associated with reduced survival in the recipient. However, that association disappeared when the data were adjusted to account for the total number of transfusions a patient received, a marker of their severity of illness. The hazard ratio per transfusion from a donor younger than age 20 was 0.98, and the hazard ratio per transfusion from a female donor was 0.99. This pattern also occurred in sensitivity analyses, the investigators noted (JAMA Intern. Med. 2017 April 24. doi: 10.1001/jamainternmed.2017.0890).
“When studying associations between ... transfusions with a particular characteristic and the risk of death in the recipient, [the] underlying disease severity ... may still confound the association. However, with meticulous adjustment for total number of transfusions, it should be possible to block the confounding effect of patient disease severity entirely,” they noted.
“We believe that, rather than reflecting true biologic effects, the Canadian results can be explained by residual confounding (i.e., that the observations resulted from incomplete adjustment for the number of transfusions),” Dr. Edgren and his associates said.
“In addition, we believe these data reinforce the importance of extreme caution in assessing epidemiologic analyses in this field, given the tremendous clinical and logistical implications of false-positive findings,” they added.
The age and sex of blood donors do not affect the recipient’s survival and do not need to be considered in blood allocation, according to a report published online April 24 in JAMA Internal Medicine.
A recent observational Canadian study suggested that blood from young donors and female donors increased the recipients’ risk of death – a finding which, if confirmed, would have immediate implications for medical practice.
A separate group of Scandinavian researchers attempted to replicate these findings by performing a retrospective cohort study using similar but more nuanced statistical methods. Gustaf Edgren, MD, PhD, of the department of medical epidemiology and biostatistics, Karolinska Institutet, Stockholm, and his associates analyzed information collected on 968,264 patients over a 10-year period from a Swedish and Danish transfusion database.
In initial, unadjusted analyses, both extremes of age (young and old) and female sex in the donor were associated with reduced survival in the recipient. However, that association disappeared when the data were adjusted to account for the total number of transfusions a patient received, a marker of their severity of illness. The hazard ratio per transfusion from a donor younger than age 20 was 0.98, and the hazard ratio per transfusion from a female donor was 0.99. This pattern also occurred in sensitivity analyses, the investigators noted (JAMA Intern. Med. 2017 April 24. doi: 10.1001/jamainternmed.2017.0890).
“When studying associations between ... transfusions with a particular characteristic and the risk of death in the recipient, [the] underlying disease severity ... may still confound the association. However, with meticulous adjustment for total number of transfusions, it should be possible to block the confounding effect of patient disease severity entirely,” they noted.
“We believe that, rather than reflecting true biologic effects, the Canadian results can be explained by residual confounding (i.e., that the observations resulted from incomplete adjustment for the number of transfusions),” Dr. Edgren and his associates said.
“In addition, we believe these data reinforce the importance of extreme caution in assessing epidemiologic analyses in this field, given the tremendous clinical and logistical implications of false-positive findings,” they added.
Key clinical point: The age and sex of blood donors do not affect the recipient’s survival and do not need to be considered in blood allocation.
Major finding: The hazard ratio per transfusion from a donor younger than age 20 was 0.98, and the hazard ratio per transfusion from a female donor was 0.99.
Data source: A retrospective cohort study involving 968,264 transfusion recipients in Sweden and Denmark during a 10-year period.
Disclosures: The Swedish Research Council, the Swedish Heart-Lung Foundation, the Swedish Society for Medical Research, Karolinska Institutet’s Strategic Research Program, and the Danish Council for Independent Research supported the study. Dr. Edgren and his associates reported having no relevant financial disclosures.
VIDEO: Study confirms uneven access to liver cancer treatment at VA hospitals
Only 25% of Veterans Affairs (VA) patients with potentially curable (Barcelona Clinic Liver Cancer stage 0/A) hepatocellular carcinoma received resection, transplantation, or ablative therapy, according to the results of a national retrospective cohort study published in the June issue of Gastroenterology (doi: 10.1053/j.gastro.2017.02.040).
Furthermore, 13% of the fittest (ECOG performance status 1-2) patients received no active treatment for their hepatocellular carcinoma, Marina Serper, MD, of Corporal Michael J. Crescenz VA Medical Center, Philadelphia, and Tamar H. Taddei, MD, of VA New York Harbor Health Care System, Brooklyn, New York, wrote with their associates in Gastroenterology.
Source: American Gastroenterological Association
“Delivery of curative therapies conferred the highest survival benefit, and notable geographic and specialist variation was observed in the delivery of active treatment,” they added. “Future studies should further evaluate modifiable health system and provider-specific barriers to delivering high quality, multidisciplinary care in hepatocellular carcinoma [in order] to optimize patient outcomes.”
Hepatocellular carcinoma ranks second worldwide and fifth in the United States as a cause of cancer mortality. Gastroenterologists, hepatologists, medical oncologists, or surgeons may take primary responsibility for treatment in community settings, but little is known about how provider and health system factors affect outcomes or the likelihood of receiving active treatments, such as liver transplantation, resection, ablative or transarterial therapy, sorafenib, systemic chemotherapy, or radiation. Accordingly, the researchers reviewed medical records and demographic data from all 3,988 U.S. patients diagnosed with hepatocellular carcinoma between 2008 and 2010 who received care at 128 Veterans Affairs centers. Patients were followed through the end of 2014. Data were from the Veterans Outcomes and Costs Associated with Liver Disease (VOCAL) cohort study (Gastroenterology. 2017 Mar 7. doi: 10.1053/j.gastro.2017.02.040).
After diagnosis, most (54%) patients only underwent transarterial palliative therapy, and 24% received no cancer treatment, the researchers reported. Being treated at an academically affiliated VA hospital nearly doubled the odds of receiving active therapy (odds ratio, 1.97; 95% confidence interval, 1.6 to 2.4; P less than .001), even after the researchers controlled for race, Charlson-Deyo comorbidity, and presenting Barcelona Clinic Liver Cancer stage. Evaluation by multiple specialists also significantly increased the odds of active treatment (OR, 1.60; 95% CI, 1.15 to 2.21; P = .005), but review by a multidisciplinary tumor board did not (OR, 1.19; P = .1).
Receipt of active therapy also varied significantly by region. Compared with patients in the Northeastern United States, those in the mid-South were significantly less likely to receive active therapy (HR, 0.62; 95% CI, 0.44-0.85). Patients in the Southeast, Central, and Western United States also were less likely to receive active treatment than were those in the Northeast, but 95% CIs for these hazard ratios were nonsignificant. Virtual tumor boards could help overcome diagnostic and treatment delays, but costs, care coordination, patient factors, and compensation issues are major barriers against implementation, the investigators noted.
Overall survival was associated with active treatment of hepatocellular carcinoma, including liver transplantation (hazard ratio, 0.22; 95% CI, 0.16-0.31), liver resection (HR, 0.38; 95% CI, 0.28-0.52), ablative therapy (HR, 0.63; 95% CI, 0.52-0.76), and transarterial therapy (HR, 0.83; 95% CI, 0.74-0.92). Reduced mortality was associated with seeing a hepatologist (HR, 0.7), medical oncologist (HR, 0.82), or surgeon (HR, 0.79) within 30 days of diagnosis (P less than .001 for each). Undergoing review by a multidisciplinary tumor board was associated with significantly reduced mortality (HR, 0.83; P less than .001), said the researchers.
“Findings from the VOCAL cohort of predominantly older males with significant medical comorbidities are important in light of the aging U.S. population and a nearly 70% expected increase in cancer among older adults,” they wrote. Together, the results indicate that access to multidisciplinary and expert care “is critical for optimizing treatment choices and for maximizing survival, but that such access is non-uniform,” they noted. “Detailed national VA clinical and administrative data are a unique resource that may be tapped to facilitate development of a parsimonious set of evidence-based, patient-centered, liver cancer–specific quality measures,” they emphasized. Quality measures based on timeliness, receipt of appropriate care, survival, or patient-reported outcomes “could be applicable both within and outside the VA system.”
The study was funded by unrestricted grants from Bayer Healthcare Pharmaceuticals and the VA HIV, Hepatitis and Public Health Pathogens Programs. The investigators had no conflicts.
The treatment of hepatocellular carcinoma (HCC) can be challenging because of the presence of underlying chronic liver disease and cirrhosis in the majority of patients. The study by Dr. Serper and colleagues evaluated the care of patients diagnosed with HCC in the Veterans Affairs (VA) system between 2008 and 2010. There are important aspects of this study worth highlighting.
First, 36% of patients presented with early-stage HCC and clearly had a better overall survival. This highlights the need for surveillance of patients with cirrhosis not only in the VA but also in other health systems. Second, only a minority of patients with early-stage HCC received curative interventions. In order to improve outcomes, patients with early stage disease should receive appropriate curative interventions. Third, gastroenterologists saw a large number of patients with HCC in the VA system, but, unfortunately, this led to less receipt of active therapy and a trend for a worse all-cause mortality, compared with hepatologists and other specialties. It is critical that gastroenterologists refer patients to specialties more adept at treating HCC in order to achieve better outcomes.
Lastly, only 34% of patients with HCC were managed via a multidisciplinary tumor conference. Importantly, these patients had an increased probability of receipt of active treatment and a 17% reduction in all-cause mortality. Our group has shown that a multidisciplinary approach to treating HCC improves overall survival. It is critical that medical centers develop a multidisciplinary treatment approach to HCC.
Jorge A. Marrero, MD, MS, AGAF, is professor of medicine and medical director for liver transplantation at UT Southwestern Medical Center Dallas. He has no conflicts of interest to report regarding this manuscript or commentary.
The treatment of hepatocellular carcinoma (HCC) can be challenging because of the presence of underlying chronic liver disease and cirrhosis in the majority of patients. The study by Dr. Serper and colleagues evaluated the care of patients diagnosed with HCC in the Veterans Affairs (VA) system between 2008 and 2010. There are important aspects of this study worth highlighting.
First, 36% of patients presented with early-stage HCC and clearly had a better overall survival. This highlights the need for surveillance of patients with cirrhosis not only in the VA but also in other health systems. Second, only a minority of patients with early-stage HCC received curative interventions. In order to improve outcomes, patients with early stage disease should receive appropriate curative interventions. Third, gastroenterologists saw a large number of patients with HCC in the VA system, but, unfortunately, this led to less receipt of active therapy and a trend for a worse all-cause mortality, compared with hepatologists and other specialties. It is critical that gastroenterologists refer patients to specialties more adept at treating HCC in order to achieve better outcomes.
Lastly, only 34% of patients with HCC were managed via a multidisciplinary tumor conference. Importantly, these patients had an increased probability of receipt of active treatment and a 17% reduction in all-cause mortality. Our group has shown that a multidisciplinary approach to treating HCC improves overall survival. It is critical that medical centers develop a multidisciplinary treatment approach to HCC.
Jorge A. Marrero, MD, MS, AGAF, is professor of medicine and medical director for liver transplantation at UT Southwestern Medical Center Dallas. He has no conflicts of interest to report regarding this manuscript or commentary.
The treatment of hepatocellular carcinoma (HCC) can be challenging because of the presence of underlying chronic liver disease and cirrhosis in the majority of patients. The study by Dr. Serper and colleagues evaluated the care of patients diagnosed with HCC in the Veterans Affairs (VA) system between 2008 and 2010. There are important aspects of this study worth highlighting.
First, 36% of patients presented with early-stage HCC and clearly had a better overall survival. This highlights the need for surveillance of patients with cirrhosis not only in the VA but also in other health systems. Second, only a minority of patients with early-stage HCC received curative interventions. In order to improve outcomes, patients with early stage disease should receive appropriate curative interventions. Third, gastroenterologists saw a large number of patients with HCC in the VA system, but, unfortunately, this led to less receipt of active therapy and a trend for a worse all-cause mortality, compared with hepatologists and other specialties. It is critical that gastroenterologists refer patients to specialties more adept at treating HCC in order to achieve better outcomes.
Lastly, only 34% of patients with HCC were managed via a multidisciplinary tumor conference. Importantly, these patients had an increased probability of receipt of active treatment and a 17% reduction in all-cause mortality. Our group has shown that a multidisciplinary approach to treating HCC improves overall survival. It is critical that medical centers develop a multidisciplinary treatment approach to HCC.
Jorge A. Marrero, MD, MS, AGAF, is professor of medicine and medical director for liver transplantation at UT Southwestern Medical Center Dallas. He has no conflicts of interest to report regarding this manuscript or commentary.
Only 25% of Veterans Affairs (VA) patients with potentially curable (Barcelona Clinic Liver Cancer stage 0/A) hepatocellular carcinoma received resection, transplantation, or ablative therapy, according to the results of a national retrospective cohort study published in the June issue of Gastroenterology (doi: 10.1053/j.gastro.2017.02.040).
Furthermore, 13% of the fittest (ECOG performance status 1-2) patients received no active treatment for their hepatocellular carcinoma, Marina Serper, MD, of Corporal Michael J. Crescenz VA Medical Center, Philadelphia, and Tamar H. Taddei, MD, of VA New York Harbor Health Care System, Brooklyn, New York, wrote with their associates in Gastroenterology.
Source: American Gastroenterological Association
“Delivery of curative therapies conferred the highest survival benefit, and notable geographic and specialist variation was observed in the delivery of active treatment,” they added. “Future studies should further evaluate modifiable health system and provider-specific barriers to delivering high quality, multidisciplinary care in hepatocellular carcinoma [in order] to optimize patient outcomes.”
Hepatocellular carcinoma ranks second worldwide and fifth in the United States as a cause of cancer mortality. Gastroenterologists, hepatologists, medical oncologists, or surgeons may take primary responsibility for treatment in community settings, but little is known about how provider and health system factors affect outcomes or the likelihood of receiving active treatments, such as liver transplantation, resection, ablative or transarterial therapy, sorafenib, systemic chemotherapy, or radiation. Accordingly, the researchers reviewed medical records and demographic data from all 3,988 U.S. patients diagnosed with hepatocellular carcinoma between 2008 and 2010 who received care at 128 Veterans Affairs centers. Patients were followed through the end of 2014. Data were from the Veterans Outcomes and Costs Associated with Liver Disease (VOCAL) cohort study (Gastroenterology. 2017 Mar 7. doi: 10.1053/j.gastro.2017.02.040).
After diagnosis, most (54%) patients only underwent transarterial palliative therapy, and 24% received no cancer treatment, the researchers reported. Being treated at an academically affiliated VA hospital nearly doubled the odds of receiving active therapy (odds ratio, 1.97; 95% confidence interval, 1.6 to 2.4; P less than .001), even after the researchers controlled for race, Charlson-Deyo comorbidity, and presenting Barcelona Clinic Liver Cancer stage. Evaluation by multiple specialists also significantly increased the odds of active treatment (OR, 1.60; 95% CI, 1.15 to 2.21; P = .005), but review by a multidisciplinary tumor board did not (OR, 1.19; P = .1).
Receipt of active therapy also varied significantly by region. Compared with patients in the Northeastern United States, those in the mid-South were significantly less likely to receive active therapy (HR, 0.62; 95% CI, 0.44-0.85). Patients in the Southeast, Central, and Western United States also were less likely to receive active treatment than were those in the Northeast, but 95% CIs for these hazard ratios were nonsignificant. Virtual tumor boards could help overcome diagnostic and treatment delays, but costs, care coordination, patient factors, and compensation issues are major barriers against implementation, the investigators noted.
Overall survival was associated with active treatment of hepatocellular carcinoma, including liver transplantation (hazard ratio, 0.22; 95% CI, 0.16-0.31), liver resection (HR, 0.38; 95% CI, 0.28-0.52), ablative therapy (HR, 0.63; 95% CI, 0.52-0.76), and transarterial therapy (HR, 0.83; 95% CI, 0.74-0.92). Reduced mortality was associated with seeing a hepatologist (HR, 0.7), medical oncologist (HR, 0.82), or surgeon (HR, 0.79) within 30 days of diagnosis (P less than .001 for each). Undergoing review by a multidisciplinary tumor board was associated with significantly reduced mortality (HR, 0.83; P less than .001), said the researchers.
“Findings from the VOCAL cohort of predominantly older males with significant medical comorbidities are important in light of the aging U.S. population and a nearly 70% expected increase in cancer among older adults,” they wrote. Together, the results indicate that access to multidisciplinary and expert care “is critical for optimizing treatment choices and for maximizing survival, but that such access is non-uniform,” they noted. “Detailed national VA clinical and administrative data are a unique resource that may be tapped to facilitate development of a parsimonious set of evidence-based, patient-centered, liver cancer–specific quality measures,” they emphasized. Quality measures based on timeliness, receipt of appropriate care, survival, or patient-reported outcomes “could be applicable both within and outside the VA system.”
The study was funded by unrestricted grants from Bayer Healthcare Pharmaceuticals and the VA HIV, Hepatitis and Public Health Pathogens Programs. The investigators had no conflicts.
Only 25% of Veterans Affairs (VA) patients with potentially curable (Barcelona Clinic Liver Cancer stage 0/A) hepatocellular carcinoma received resection, transplantation, or ablative therapy, according to the results of a national retrospective cohort study published in the June issue of Gastroenterology (doi: 10.1053/j.gastro.2017.02.040).
Furthermore, 13% of the fittest (ECOG performance status 1-2) patients received no active treatment for their hepatocellular carcinoma, Marina Serper, MD, of Corporal Michael J. Crescenz VA Medical Center, Philadelphia, and Tamar H. Taddei, MD, of VA New York Harbor Health Care System, Brooklyn, New York, wrote with their associates in Gastroenterology.
Source: American Gastroenterological Association
“Delivery of curative therapies conferred the highest survival benefit, and notable geographic and specialist variation was observed in the delivery of active treatment,” they added. “Future studies should further evaluate modifiable health system and provider-specific barriers to delivering high quality, multidisciplinary care in hepatocellular carcinoma [in order] to optimize patient outcomes.”
Hepatocellular carcinoma ranks second worldwide and fifth in the United States as a cause of cancer mortality. Gastroenterologists, hepatologists, medical oncologists, or surgeons may take primary responsibility for treatment in community settings, but little is known about how provider and health system factors affect outcomes or the likelihood of receiving active treatments, such as liver transplantation, resection, ablative or transarterial therapy, sorafenib, systemic chemotherapy, or radiation. Accordingly, the researchers reviewed medical records and demographic data from all 3,988 U.S. patients diagnosed with hepatocellular carcinoma between 2008 and 2010 who received care at 128 Veterans Affairs centers. Patients were followed through the end of 2014. Data were from the Veterans Outcomes and Costs Associated with Liver Disease (VOCAL) cohort study (Gastroenterology. 2017 Mar 7. doi: 10.1053/j.gastro.2017.02.040).
After diagnosis, most (54%) patients only underwent transarterial palliative therapy, and 24% received no cancer treatment, the researchers reported. Being treated at an academically affiliated VA hospital nearly doubled the odds of receiving active therapy (odds ratio, 1.97; 95% confidence interval, 1.6 to 2.4; P less than .001), even after the researchers controlled for race, Charlson-Deyo comorbidity, and presenting Barcelona Clinic Liver Cancer stage. Evaluation by multiple specialists also significantly increased the odds of active treatment (OR, 1.60; 95% CI, 1.15 to 2.21; P = .005), but review by a multidisciplinary tumor board did not (OR, 1.19; P = .1).
Receipt of active therapy also varied significantly by region. Compared with patients in the Northeastern United States, those in the mid-South were significantly less likely to receive active therapy (HR, 0.62; 95% CI, 0.44-0.85). Patients in the Southeast, Central, and Western United States also were less likely to receive active treatment than were those in the Northeast, but 95% CIs for these hazard ratios were nonsignificant. Virtual tumor boards could help overcome diagnostic and treatment delays, but costs, care coordination, patient factors, and compensation issues are major barriers against implementation, the investigators noted.
Overall survival was associated with active treatment of hepatocellular carcinoma, including liver transplantation (hazard ratio, 0.22; 95% CI, 0.16-0.31), liver resection (HR, 0.38; 95% CI, 0.28-0.52), ablative therapy (HR, 0.63; 95% CI, 0.52-0.76), and transarterial therapy (HR, 0.83; 95% CI, 0.74-0.92). Reduced mortality was associated with seeing a hepatologist (HR, 0.7), medical oncologist (HR, 0.82), or surgeon (HR, 0.79) within 30 days of diagnosis (P less than .001 for each). Undergoing review by a multidisciplinary tumor board was associated with significantly reduced mortality (HR, 0.83; P less than .001), said the researchers.
“Findings from the VOCAL cohort of predominantly older males with significant medical comorbidities are important in light of the aging U.S. population and a nearly 70% expected increase in cancer among older adults,” they wrote. Together, the results indicate that access to multidisciplinary and expert care “is critical for optimizing treatment choices and for maximizing survival, but that such access is non-uniform,” they noted. “Detailed national VA clinical and administrative data are a unique resource that may be tapped to facilitate development of a parsimonious set of evidence-based, patient-centered, liver cancer–specific quality measures,” they emphasized. Quality measures based on timeliness, receipt of appropriate care, survival, or patient-reported outcomes “could be applicable both within and outside the VA system.”
The study was funded by unrestricted grants from Bayer Healthcare Pharmaceuticals and the VA HIV, Hepatitis and Public Health Pathogens Programs. The investigators had no conflicts.
FROM GASTROENTEROLOGY
Key clinical point: Undertreatment of hepatocellular carcinoma was common within the Veterans Affairs system, and varied by geographic region.
Major finding: Only 25% of Barcelona Clinic Liver Cancer stage 0/A patients received potentially curative therapies. Those in the mid-South were significantly less likely to receive active treatment than were those in the Northeast (HR, 0.62; 95% CI, 0.44-0.85). In an adjusted model, treatment at an academically affiliated VA hospital nearly doubled the odds of receiving active therapy (odds ratio, 1.97; P less than .001).
Data source: A national, retrospective cohort study of all 3,988 patients who were diagnosed with hepatocellular carcinoma between 2008 and 2010 and received care through Veterans Affairs.
Disclosures: The study was funded by unrestricted grants from Bayer Healthcare Pharmaceuticals and the VA HIV, Hepatitis and Public Health Pathogens Programs. The investigators had no conflicts.
