On the third day of the American Heart Association scientific sessions, antithrombotic therapy is the focus of the Late-Breaking Science 5 presentation, at 10:45 a.m.-12 p.m. on Tuesday, Nov. 14, followed by innovative investigations in evaluating quality improvement and patient-centered care interventions in the Late-Breaking Science 6 session, to be held at 3:45-5:15 p.m. Here are some highlights.

Late-Breaking Science 5, antithrombotic therapy

• RE-DUAL PCI: Jonas Oldgren, MD, of Uppsala (Sweden) University, will present an unspecified subgroup analysis from the RE-DUAL PCI (Dual Antithrombotic Therapy With Dabigatran in Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention) trial, focusing on one arm of the study. The main results, presented in August, showed patients with atrial fibrillation who had undergone percutaneous coronary intervention had a lower risk of bleeding if they received dual therapy with dabigatran plus clopidogrel or ticagrelor than did those treated with warfarin, clopidogrel, or ticagrelor.
• POISE-2 PCI: Michelle M. Graham, MD, of the University of Alberta, Edmonton, will present a substudy of POISE-2 focusing on the patients in undergoing noncardiac surgery who had a previous percutaneous coronary intervention. POISE-2, published in 2014, showed that administering aspirin periprocedurally had no effect on the rate of a composite of death or nonfatal MI, but increased the risk of major bleeding.

  

• GEMINI-ACS-1: In the main study, the risk of major bleeding was similar between ACS patients treated with a combination of low-dose rivaroxaban and a P2Y12 inhibitor and those treated with aspirin and P2Y12 inhibitor. Matthew T. Roe, MD, Duke Clinical Research Institute, Durham, N.C., will present the substudy focusing on P2Y12 inhibitor switching in response to routine notification of CYP2C19 clopidogrel metabolizer status following ACS.
• PRAGUE-18: Zuzana Motovska, MD, of Charles University in Prague, will present an unspecified substudy of PRAGUE-18, which in August 2016 showed no difference in safety or efficacy between prasugrel and ticagrelor in AMI patients undergoing primary angioplasty.

Late-Breaking Session 6, quality improvement and patient-centered care

The seven presentations in this session range from findings from the enormous SWEDEHEART registry on how treatments have improved for ST-elevation MI over 20 years, to STIC2IT, a cluster randomized, controlled trial to test whether a novel telepharmacist-based intervention for patients with metabolic syndrome improves medication adherence and disease control.

Other presentations include evaluation of a quality improvement toolkit on AMI in India called ACS QUIK; a trial of a decision support intervention for patients and caregivers offered a heart assist device as destination therapy called DECIDE-LVAD; a national rollout of a clinical guidance framework for the assessment of patients with possible ACS in emergency departments (iCARE-ACS); and a report from the American College of Cardiology’s Mission: Lifeline STEMI ACCELERATOR-2 study.

[email protected]

On Twitter @cardionews

On the third day of the American Heart Association scientific sessions, antithrombotic therapy is the focus of the Late-Breaking Science 5 presentation, at 10:45 a.m.-12 p.m. on Tuesday, Nov. 14, followed by innovative investigations in evaluating quality improvement and patient-centered care interventions in the Late-Breaking Science 6 session, to be held at 3:45-5:15 p.m. Here are some highlights.

Late-Breaking Science 5, antithrombotic therapy

• RE-DUAL PCI: Jonas Oldgren, MD, of Uppsala (Sweden) University, will present an unspecified subgroup analysis from the RE-DUAL PCI (Dual Antithrombotic Therapy With Dabigatran in Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention) trial, focusing on one arm of the study. The main results, presented in August, showed patients with atrial fibrillation who had undergone percutaneous coronary intervention had a lower risk of bleeding if they received dual therapy with dabigatran plus clopidogrel or ticagrelor than did those treated with warfarin, clopidogrel, or ticagrelor.
• POISE-2 PCI: Michelle M. Graham, MD, of the University of Alberta, Edmonton, will present a substudy of POISE-2 focusing on the patients in undergoing noncardiac surgery who had a previous percutaneous coronary intervention. POISE-2, published in 2014, showed that administering aspirin periprocedurally had no effect on the rate of a composite of death or nonfatal MI, but increased the risk of major bleeding.

  

• GEMINI-ACS-1: In the main study, the risk of major bleeding was similar between ACS patients treated with a combination of low-dose rivaroxaban and a P2Y12 inhibitor and those treated with aspirin and P2Y12 inhibitor. Matthew T. Roe, MD, Duke Clinical Research Institute, Durham, N.C., will present the substudy focusing on P2Y12 inhibitor switching in response to routine notification of CYP2C19 clopidogrel metabolizer status following ACS.
• PRAGUE-18: Zuzana Motovska, MD, of Charles University in Prague, will present an unspecified substudy of PRAGUE-18, which in August 2016 showed no difference in safety or efficacy between prasugrel and ticagrelor in AMI patients undergoing primary angioplasty.

Late-Breaking Session 6, quality improvement and patient-centered care

The seven presentations in this session range from findings from the enormous SWEDEHEART registry on how treatments have improved for ST-elevation MI over 20 years, to STIC2IT, a cluster randomized, controlled trial to test whether a novel telepharmacist-based intervention for patients with metabolic syndrome improves medication adherence and disease control.

Other presentations include evaluation of a quality improvement toolkit on AMI in India called ACS QUIK; a trial of a decision support intervention for patients and caregivers offered a heart assist device as destination therapy called DECIDE-LVAD; a national rollout of a clinical guidance framework for the assessment of patients with possible ACS in emergency departments (iCARE-ACS); and a report from the American College of Cardiology’s Mission: Lifeline STEMI ACCELERATOR-2 study.

[email protected]

On Twitter @cardionews

On the third day of the American Heart Association scientific sessions, antithrombotic therapy is the focus of the Late-Breaking Science 5 presentation, at 10:45 a.m.-12 p.m. on Tuesday, Nov. 14, followed by innovative investigations in evaluating quality improvement and patient-centered care interventions in the Late-Breaking Science 6 session, to be held at 3:45-5:15 p.m. Here are some highlights.

Late-Breaking Science 5, antithrombotic therapy

• RE-DUAL PCI: Jonas Oldgren, MD, of Uppsala (Sweden) University, will present an unspecified subgroup analysis from the RE-DUAL PCI (Dual Antithrombotic Therapy With Dabigatran in Patients With Atrial Fibrillation Undergoing Percutaneous Coronary Intervention) trial, focusing on one arm of the study. The main results, presented in August, showed patients with atrial fibrillation who had undergone percutaneous coronary intervention had a lower risk of bleeding if they received dual therapy with dabigatran plus clopidogrel or ticagrelor than did those treated with warfarin, clopidogrel, or ticagrelor.
• POISE-2 PCI: Michelle M. Graham, MD, of the University of Alberta, Edmonton, will present a substudy of POISE-2 focusing on the patients in undergoing noncardiac surgery who had a previous percutaneous coronary intervention. POISE-2, published in 2014, showed that administering aspirin periprocedurally had no effect on the rate of a composite of death or nonfatal MI, but increased the risk of major bleeding.

  

• GEMINI-ACS-1: In the main study, the risk of major bleeding was similar between ACS patients treated with a combination of low-dose rivaroxaban and a P2Y12 inhibitor and those treated with aspirin and P2Y12 inhibitor. Matthew T. Roe, MD, Duke Clinical Research Institute, Durham, N.C., will present the substudy focusing on P2Y12 inhibitor switching in response to routine notification of CYP2C19 clopidogrel metabolizer status following ACS.
• PRAGUE-18: Zuzana Motovska, MD, of Charles University in Prague, will present an unspecified substudy of PRAGUE-18, which in August 2016 showed no difference in safety or efficacy between prasugrel and ticagrelor in AMI patients undergoing primary angioplasty.

Late-Breaking Session 6, quality improvement and patient-centered care

The seven presentations in this session range from findings from the enormous SWEDEHEART registry on how treatments have improved for ST-elevation MI over 20 years, to STIC2IT, a cluster randomized, controlled trial to test whether a novel telepharmacist-based intervention for patients with metabolic syndrome improves medication adherence and disease control.

Other presentations include evaluation of a quality improvement toolkit on AMI in India called ACS QUIK; a trial of a decision support intervention for patients and caregivers offered a heart assist device as destination therapy called DECIDE-LVAD; a national rollout of a clinical guidance framework for the assessment of patients with possible ACS in emergency departments (iCARE-ACS); and a report from the American College of Cardiology’s Mission: Lifeline STEMI ACCELERATOR-2 study.

[email protected]

On Twitter @cardionews

NATIONAL HARBOR, MD. – Psychological screening prior to bariatric surgery is not effective for identifying who will do poorly after the procedure, but it can identify patients who are at risk for less weight loss and likely to benefit from additional support, according to one of the largest studies designed to evaluate the predictive accuracy of this screening. The results were presented at Obesity Week 2017.

“Psychological evaluations should not be used to exclude patients, because we do not appear to be very good at predicting who does well,” said Nina E. Boulard, PhD, a psychologist who currently performs preoperative psychological screening of bariatric surgery candidates at Eastern Maine Medical Center, Bangor. Rather, “our evaluations identify those who need to be followed more closely so we can intervene early when patients struggle,” she said at an annual meeting presented by the American Society for Metabolic and Bariatric Surgery and The Obesity Society.

NATIONAL HARBOR, MD. – Psychological screening prior to bariatric surgery is not effective for identifying who will do poorly after the procedure, but it can identify patients who are at risk for less weight loss and likely to benefit from additional support, according to one of the largest studies designed to evaluate the predictive accuracy of this screening. The results were presented at Obesity Week 2017.

“Psychological evaluations should not be used to exclude patients, because we do not appear to be very good at predicting who does well,” said Nina E. Boulard, PhD, a psychologist who currently performs preoperative psychological screening of bariatric surgery candidates at Eastern Maine Medical Center, Bangor. Rather, “our evaluations identify those who need to be followed more closely so we can intervene early when patients struggle,” she said at an annual meeting presented by the American Society for Metabolic and Bariatric Surgery and The Obesity Society.

NATIONAL HARBOR, MD. – Psychological screening prior to bariatric surgery is not effective for identifying who will do poorly after the procedure, but it can identify patients who are at risk for less weight loss and likely to benefit from additional support, according to one of the largest studies designed to evaluate the predictive accuracy of this screening. The results were presented at Obesity Week 2017.

“Psychological evaluations should not be used to exclude patients, because we do not appear to be very good at predicting who does well,” said Nina E. Boulard, PhD, a psychologist who currently performs preoperative psychological screening of bariatric surgery candidates at Eastern Maine Medical Center, Bangor. Rather, “our evaluations identify those who need to be followed more closely so we can intervene early when patients struggle,” she said at an annual meeting presented by the American Society for Metabolic and Bariatric Surgery and The Obesity Society.

Pregnant women who were offered access to a website with vaccine information and interactive social media were more likely to vaccinate their infants on time than were those receiving usual care, said Jason M. Glanz, PhD, of the Institute for Health Research, Kaiser Permanente Colorado, Denver, and his associates.

“These results suggest that interactive, informational interventions administered outside of the physician’s office can improve vaccine acceptance,” the investigators said. “The information appears to be effective when presented to parents before their children are born.”

GEOLEE/Thinkstock

[email protected]

Pregnant women who were offered access to a website with vaccine information and interactive social media were more likely to vaccinate their infants on time than were those receiving usual care, said Jason M. Glanz, PhD, of the Institute for Health Research, Kaiser Permanente Colorado, Denver, and his associates.

“These results suggest that interactive, informational interventions administered outside of the physician’s office can improve vaccine acceptance,” the investigators said. “The information appears to be effective when presented to parents before their children are born.”

GEOLEE/Thinkstock

[email protected]

Pregnant women who were offered access to a website with vaccine information and interactive social media were more likely to vaccinate their infants on time than were those receiving usual care, said Jason M. Glanz, PhD, of the Institute for Health Research, Kaiser Permanente Colorado, Denver, and his associates.

“These results suggest that interactive, informational interventions administered outside of the physician’s office can improve vaccine acceptance,” the investigators said. “The information appears to be effective when presented to parents before their children are born.”

GEOLEE/Thinkstock

[email protected]

Analyses of landmark, practice-changing trials will pepper the three late-breaking science sessions.

Late-Breaking Science 2

The Late-Breaking Science 2 session will focus on prevention and will include analyses from the two most illuminating and perhaps practice-changing trials presented this year, FOURIER and CANTOS. REVEAL, another large and important trial of 2017, also spawned a subanalysis in this deep-diving session at 9:00 a.m.-10:15 a.m.:

Bruce Jancin/Frontline Medical News

• REAL-CAD: This study evaluated the prevention of cardiovascular disease with pitavastatin 1 mg/day or 4 mg/day in patients with stable coronary artery disease followed for 3-6 years. In the REAL-CAD (Randomized Evaluation of Aggressive or Moderate Lipid Lowering Therapy With Pitavastatin in Coronary Artery Disease) trial, presented by Takeshi Kimura, MD, of Kyoto (Japan) University, the primary endpoint was the occurrence of cardiovascular death, nonfatal MI, nonfatal cerebral infarction, or unstable angina.
• REVEAL: Presented in August at the European Society of Cardiology Congress (ESC), the primary results of REVEAL (Randomized Evaluation of the Effects of Anacetrapib Through Lipid-Modification), a multicenter, pivotal trial with more than 30,000 patients treated for about 4 years, showed that patients treated with anacetrapib had a statistically significant 9% decrease in major coronary events, compared with placebo-treated controls. The analysis to be presented at AHA by Martin Landrey, MD of the University of Oxford, England, examined the effects of anacetrapib on the incidence of new-onset diabetes and on vascular events in people with diabetes.

  

  Frontline Medical News

• FOURIER: This blockbuster trial in more than 27,000 patients showed that the PCSK9 inhibitor evolocumab significantly improved cardiovascular outcomes in high-risk patients already on statin therapy and has already started spawning important subanalyses. Two will be presented in this session. First, Marc P. Bonaca, MD, of Brigham & Women’s Hospital in Boston, will present outcomes in patients with peripheral artery disease. Second, Marc S. Sabatine, MD, also of Brigham & Women’s, will present the clinical benefit of evolocumab in patients with a history of MI.

  

• CANTOS: The findings of CANTOS (Canakinumab Anti-Inflammatory Thrombosis Outcome Study) stunned the cardiovascular world and piqued interest in their oncology colleagues. “These data provide the first proof that inflammation inhibition in the absence of lipid lowering can improve atherogenic outcomes and potentially alter progression of some fatal cancers,” declared Paul M. Ridker, MD, of Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, both in Boston, at ESC. In CANTOS, the fully human monoclonal antibody canakinumab, which targets IL-1B, reduced the risk of recurrent cardiovascular events by 15% in a very-high-risk population, compared with placebo, while cutting incident lung cancer by 67%.

Late-Breaking Science 3

This session promises insights into hypertension management and will be held at 10:45 a.m.-12:00 p.m.:

• Chinese BP trial: Presented by Mar Pujades-Rodriguez, PhD, of the University of Leeds, (England), this study examined time at blood pressure target and the risk of cardiovascular diseases and mortality in a Chinese population.
• SPRINT: Yes, the trial that upended hypertension guidelines is bearing fruit again. This analysis of SPRINT (Systolic Blood Pressure Intervention Trial) looked at blood pressure measurement. Karen C. Johnson, MD, of the University of Tennessee, Memphis, will present the results.

  

• GATEWAY: As the benefits of bariatric surgery seem to pile up, the GATEWAY (Gastric Bypass to Treat Obese Patients With Steady Hypertension) trial focused on reducing the need for antihypertensive drugs and decreasing systemic arterial blood pressure and other risk factors for cardiovascular events in patients with arterial hypertension randomized to Roux-en-Y gastroplasty or to clinical treatments. Carlos A. Schiavon, MD, of Heart Hospital in São Paulo will present the results.

Late-Breaking Science 4

Billed as covering the “sweet spot in cardiometabolic care,” this session will highlight new findings from three of the biggest trials in type 2 diabetes management. The session will run at 3:45 p.m.-5:00 p.m.

• CANVAS: Presented at ESC, the results of this large, FDA-mandated cardiovascular outcomes trial showed that canagliflozin significantly reduced the risk of cardiovascular and renal events but doubled the risk of amputation, compared with placebo, in patients with type 2 diabetes. In this subanalysis of CANVAS (the Canagliflozin Cardiovascular Assessment Study), presenter Kenneth W. Mahaffey, MD, of Stanford (Calif.) University, and his coinvestigators looked at primary and secondary prevention of cardiovascular events in the same population.

  

  Sara Freeman/Frontline Medical News

• EXSCEL: The results of this trial, also presented at ESC, showed that exenatide was noninferior to placebo with respect to cardiovascular safety but not superior with respect to efficacy. Presenter Robert J. Mentz, MD, of Duke University, Durham, N.C., will present more news from the EXSCEL (Exenatide Study of Cardiovascular Event Lowering) trial.
• EMPA-REG OUTCOME: The first trial to show a cardioprotective effect of an SGLT-2 inhibitor in type 2 diabetes patients, EMPA-REG OUTCOME, marked a new era in diabetes treatment. Bernard Zinman, MD, of the University of Toronto, will present an subset analysis of patients with type 2 diabetes and peripheral artery disease. The session title signals more good news: Empagliflozin Reduces Mortality and Hospitalization for Heart Failure in Patients With Type 2 Diabetes and Peripheral Artery Disease.

[email protected]

On Twitter @cardionews

Analyses of landmark, practice-changing trials will pepper the three late-breaking science sessions.

Late-Breaking Science 2

The Late-Breaking Science 2 session will focus on prevention and will include analyses from the two most illuminating and perhaps practice-changing trials presented this year, FOURIER and CANTOS. REVEAL, another large and important trial of 2017, also spawned a subanalysis in this deep-diving session at 9:00 a.m.-10:15 a.m.:

Bruce Jancin/Frontline Medical News

• REAL-CAD: This study evaluated the prevention of cardiovascular disease with pitavastatin 1 mg/day or 4 mg/day in patients with stable coronary artery disease followed for 3-6 years. In the REAL-CAD (Randomized Evaluation of Aggressive or Moderate Lipid Lowering Therapy With Pitavastatin in Coronary Artery Disease) trial, presented by Takeshi Kimura, MD, of Kyoto (Japan) University, the primary endpoint was the occurrence of cardiovascular death, nonfatal MI, nonfatal cerebral infarction, or unstable angina.
• REVEAL: Presented in August at the European Society of Cardiology Congress (ESC), the primary results of REVEAL (Randomized Evaluation of the Effects of Anacetrapib Through Lipid-Modification), a multicenter, pivotal trial with more than 30,000 patients treated for about 4 years, showed that patients treated with anacetrapib had a statistically significant 9% decrease in major coronary events, compared with placebo-treated controls. The analysis to be presented at AHA by Martin Landrey, MD of the University of Oxford, England, examined the effects of anacetrapib on the incidence of new-onset diabetes and on vascular events in people with diabetes.

  

  Frontline Medical News

• FOURIER: This blockbuster trial in more than 27,000 patients showed that the PCSK9 inhibitor evolocumab significantly improved cardiovascular outcomes in high-risk patients already on statin therapy and has already started spawning important subanalyses. Two will be presented in this session. First, Marc P. Bonaca, MD, of Brigham & Women’s Hospital in Boston, will present outcomes in patients with peripheral artery disease. Second, Marc S. Sabatine, MD, also of Brigham & Women’s, will present the clinical benefit of evolocumab in patients with a history of MI.

  

• CANTOS: The findings of CANTOS (Canakinumab Anti-Inflammatory Thrombosis Outcome Study) stunned the cardiovascular world and piqued interest in their oncology colleagues. “These data provide the first proof that inflammation inhibition in the absence of lipid lowering can improve atherogenic outcomes and potentially alter progression of some fatal cancers,” declared Paul M. Ridker, MD, of Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, both in Boston, at ESC. In CANTOS, the fully human monoclonal antibody canakinumab, which targets IL-1B, reduced the risk of recurrent cardiovascular events by 15% in a very-high-risk population, compared with placebo, while cutting incident lung cancer by 67%.

Late-Breaking Science 3

This session promises insights into hypertension management and will be held at 10:45 a.m.-12:00 p.m.:

• Chinese BP trial: Presented by Mar Pujades-Rodriguez, PhD, of the University of Leeds, (England), this study examined time at blood pressure target and the risk of cardiovascular diseases and mortality in a Chinese population.
• SPRINT: Yes, the trial that upended hypertension guidelines is bearing fruit again. This analysis of SPRINT (Systolic Blood Pressure Intervention Trial) looked at blood pressure measurement. Karen C. Johnson, MD, of the University of Tennessee, Memphis, will present the results.

  

• GATEWAY: As the benefits of bariatric surgery seem to pile up, the GATEWAY (Gastric Bypass to Treat Obese Patients With Steady Hypertension) trial focused on reducing the need for antihypertensive drugs and decreasing systemic arterial blood pressure and other risk factors for cardiovascular events in patients with arterial hypertension randomized to Roux-en-Y gastroplasty or to clinical treatments. Carlos A. Schiavon, MD, of Heart Hospital in São Paulo will present the results.

Late-Breaking Science 4

Billed as covering the “sweet spot in cardiometabolic care,” this session will highlight new findings from three of the biggest trials in type 2 diabetes management. The session will run at 3:45 p.m.-5:00 p.m.

• CANVAS: Presented at ESC, the results of this large, FDA-mandated cardiovascular outcomes trial showed that canagliflozin significantly reduced the risk of cardiovascular and renal events but doubled the risk of amputation, compared with placebo, in patients with type 2 diabetes. In this subanalysis of CANVAS (the Canagliflozin Cardiovascular Assessment Study), presenter Kenneth W. Mahaffey, MD, of Stanford (Calif.) University, and his coinvestigators looked at primary and secondary prevention of cardiovascular events in the same population.

  

  Sara Freeman/Frontline Medical News

• EXSCEL: The results of this trial, also presented at ESC, showed that exenatide was noninferior to placebo with respect to cardiovascular safety but not superior with respect to efficacy. Presenter Robert J. Mentz, MD, of Duke University, Durham, N.C., will present more news from the EXSCEL (Exenatide Study of Cardiovascular Event Lowering) trial.
• EMPA-REG OUTCOME: The first trial to show a cardioprotective effect of an SGLT-2 inhibitor in type 2 diabetes patients, EMPA-REG OUTCOME, marked a new era in diabetes treatment. Bernard Zinman, MD, of the University of Toronto, will present an subset analysis of patients with type 2 diabetes and peripheral artery disease. The session title signals more good news: Empagliflozin Reduces Mortality and Hospitalization for Heart Failure in Patients With Type 2 Diabetes and Peripheral Artery Disease.

[email protected]

On Twitter @cardionews

Analyses of landmark, practice-changing trials will pepper the three late-breaking science sessions.

Late-Breaking Science 2

The Late-Breaking Science 2 session will focus on prevention and will include analyses from the two most illuminating and perhaps practice-changing trials presented this year, FOURIER and CANTOS. REVEAL, another large and important trial of 2017, also spawned a subanalysis in this deep-diving session at 9:00 a.m.-10:15 a.m.:

Bruce Jancin/Frontline Medical News

• REAL-CAD: This study evaluated the prevention of cardiovascular disease with pitavastatin 1 mg/day or 4 mg/day in patients with stable coronary artery disease followed for 3-6 years. In the REAL-CAD (Randomized Evaluation of Aggressive or Moderate Lipid Lowering Therapy With Pitavastatin in Coronary Artery Disease) trial, presented by Takeshi Kimura, MD, of Kyoto (Japan) University, the primary endpoint was the occurrence of cardiovascular death, nonfatal MI, nonfatal cerebral infarction, or unstable angina.
• REVEAL: Presented in August at the European Society of Cardiology Congress (ESC), the primary results of REVEAL (Randomized Evaluation of the Effects of Anacetrapib Through Lipid-Modification), a multicenter, pivotal trial with more than 30,000 patients treated for about 4 years, showed that patients treated with anacetrapib had a statistically significant 9% decrease in major coronary events, compared with placebo-treated controls. The analysis to be presented at AHA by Martin Landrey, MD of the University of Oxford, England, examined the effects of anacetrapib on the incidence of new-onset diabetes and on vascular events in people with diabetes.

  

  Frontline Medical News

• FOURIER: This blockbuster trial in more than 27,000 patients showed that the PCSK9 inhibitor evolocumab significantly improved cardiovascular outcomes in high-risk patients already on statin therapy and has already started spawning important subanalyses. Two will be presented in this session. First, Marc P. Bonaca, MD, of Brigham & Women’s Hospital in Boston, will present outcomes in patients with peripheral artery disease. Second, Marc S. Sabatine, MD, also of Brigham & Women’s, will present the clinical benefit of evolocumab in patients with a history of MI.

  

• CANTOS: The findings of CANTOS (Canakinumab Anti-Inflammatory Thrombosis Outcome Study) stunned the cardiovascular world and piqued interest in their oncology colleagues. “These data provide the first proof that inflammation inhibition in the absence of lipid lowering can improve atherogenic outcomes and potentially alter progression of some fatal cancers,” declared Paul M. Ridker, MD, of Brigham and Women’s Hospital and professor of medicine at Harvard Medical School, both in Boston, at ESC. In CANTOS, the fully human monoclonal antibody canakinumab, which targets IL-1B, reduced the risk of recurrent cardiovascular events by 15% in a very-high-risk population, compared with placebo, while cutting incident lung cancer by 67%.

Late-Breaking Science 3

This session promises insights into hypertension management and will be held at 10:45 a.m.-12:00 p.m.:

• Chinese BP trial: Presented by Mar Pujades-Rodriguez, PhD, of the University of Leeds, (England), this study examined time at blood pressure target and the risk of cardiovascular diseases and mortality in a Chinese population.
• SPRINT: Yes, the trial that upended hypertension guidelines is bearing fruit again. This analysis of SPRINT (Systolic Blood Pressure Intervention Trial) looked at blood pressure measurement. Karen C. Johnson, MD, of the University of Tennessee, Memphis, will present the results.

  

• GATEWAY: As the benefits of bariatric surgery seem to pile up, the GATEWAY (Gastric Bypass to Treat Obese Patients With Steady Hypertension) trial focused on reducing the need for antihypertensive drugs and decreasing systemic arterial blood pressure and other risk factors for cardiovascular events in patients with arterial hypertension randomized to Roux-en-Y gastroplasty or to clinical treatments. Carlos A. Schiavon, MD, of Heart Hospital in São Paulo will present the results.

Late-Breaking Science 4

Billed as covering the “sweet spot in cardiometabolic care,” this session will highlight new findings from three of the biggest trials in type 2 diabetes management. The session will run at 3:45 p.m.-5:00 p.m.

• CANVAS: Presented at ESC, the results of this large, FDA-mandated cardiovascular outcomes trial showed that canagliflozin significantly reduced the risk of cardiovascular and renal events but doubled the risk of amputation, compared with placebo, in patients with type 2 diabetes. In this subanalysis of CANVAS (the Canagliflozin Cardiovascular Assessment Study), presenter Kenneth W. Mahaffey, MD, of Stanford (Calif.) University, and his coinvestigators looked at primary and secondary prevention of cardiovascular events in the same population.

  

  Sara Freeman/Frontline Medical News

• EXSCEL: The results of this trial, also presented at ESC, showed that exenatide was noninferior to placebo with respect to cardiovascular safety but not superior with respect to efficacy. Presenter Robert J. Mentz, MD, of Duke University, Durham, N.C., will present more news from the EXSCEL (Exenatide Study of Cardiovascular Event Lowering) trial.
• EMPA-REG OUTCOME: The first trial to show a cardioprotective effect of an SGLT-2 inhibitor in type 2 diabetes patients, EMPA-REG OUTCOME, marked a new era in diabetes treatment. Bernard Zinman, MD, of the University of Toronto, will present an subset analysis of patients with type 2 diabetes and peripheral artery disease. The session title signals more good news: Empagliflozin Reduces Mortality and Hospitalization for Heart Failure in Patients With Type 2 Diabetes and Peripheral Artery Disease.

[email protected]

On Twitter @cardionews

Fear of malpractice litigation weighs on many physicians, including hospitalists. Specific concerns that physicians have about facing a malpractice claim include stigmatization, loss of confidence in one’s own clinical skills, and a possible personal financial toll if an award exceeds the limit of one’s malpractice insurance.

Physician worries about malpractice are increasingly being raised during discussions of burnout, with a recent National Academy of Medicine discussion paper listing malpractice concerns as a possible factor that could contribute to physician burnout.¹

Dr. Schaffer is an attending physician in the Hospital Medicine Unit at Brigham and Women’s Hospital, an instructor at Harvard Medical School, and a senior clinical analytics specialist at CRICO/Risk Management Foundation of the Harvard Medical Institutions, all in Boston. Dr. Kachalia is an attending physician in the Hospital Medicine Unit at Brigham and Women’s Hospital, an associate professor at Harvard Medical School, and the chief quality officer at Brigham and Women’s Hospital.

References

1. Dyrbye LN et al. Burnout among health care professionals: A call to explore and address this underrecognized threat to safe, high-quality care. National Academy of Medicine Perspectives. 2017 Jul 5.

2. Helland E et al. Bargaining in the shadow of the website: Disclosure’s impact on medical malpractice litigation. American Law and Economics Review. 2010;12(2):423-61.

3. Bishop TF et al. Physicians’ views on defensive medicine: A national survey. Arch Intern Med. Jun 28 2010;170(12):1081-3.

4. Kachalia A et al. Overuse of testing in preoperative evaluation and syncope: A survey of hospitalists. Ann Intern Med. 2015 Jan 20;162(2):100-8.

5. Schaffer AC et al. Liability impact of the hospitalist model of care. J Hosp Med. Dec 2014;9(12):750-5.

6. CRICO Strategies. Medication-related malpractice risks: 2016 CBS Benchmarking Report. Boston. The Risk Management Foundation of Harvard Medical Institutions; 2016. Available at: www.rmf.harvard.edu/cbsreport (accessed Sept. 14, 2017).

7. Schaffer AC et al. Rates and characteristics of paid malpractice claims among US physicians by specialty, 1992-2014. JAMA Intern Med. May 2017;177(5):710-8.

8. Kachalia A et al. Liability claims and costs before and after implementation of a medical error disclosure program. Ann Intern Med. Aug 17 2010;153(4):213-21.
 

Fear of malpractice litigation weighs on many physicians, including hospitalists. Specific concerns that physicians have about facing a malpractice claim include stigmatization, loss of confidence in one’s own clinical skills, and a possible personal financial toll if an award exceeds the limit of one’s malpractice insurance.

Physician worries about malpractice are increasingly being raised during discussions of burnout, with a recent National Academy of Medicine discussion paper listing malpractice concerns as a possible factor that could contribute to physician burnout.¹

Dr. Schaffer is an attending physician in the Hospital Medicine Unit at Brigham and Women’s Hospital, an instructor at Harvard Medical School, and a senior clinical analytics specialist at CRICO/Risk Management Foundation of the Harvard Medical Institutions, all in Boston. Dr. Kachalia is an attending physician in the Hospital Medicine Unit at Brigham and Women’s Hospital, an associate professor at Harvard Medical School, and the chief quality officer at Brigham and Women’s Hospital.

References

1. Dyrbye LN et al. Burnout among health care professionals: A call to explore and address this underrecognized threat to safe, high-quality care. National Academy of Medicine Perspectives. 2017 Jul 5.

2. Helland E et al. Bargaining in the shadow of the website: Disclosure’s impact on medical malpractice litigation. American Law and Economics Review. 2010;12(2):423-61.

3. Bishop TF et al. Physicians’ views on defensive medicine: A national survey. Arch Intern Med. Jun 28 2010;170(12):1081-3.

4. Kachalia A et al. Overuse of testing in preoperative evaluation and syncope: A survey of hospitalists. Ann Intern Med. 2015 Jan 20;162(2):100-8.

5. Schaffer AC et al. Liability impact of the hospitalist model of care. J Hosp Med. Dec 2014;9(12):750-5.

6. CRICO Strategies. Medication-related malpractice risks: 2016 CBS Benchmarking Report. Boston. The Risk Management Foundation of Harvard Medical Institutions; 2016. Available at: www.rmf.harvard.edu/cbsreport (accessed Sept. 14, 2017).

7. Schaffer AC et al. Rates and characteristics of paid malpractice claims among US physicians by specialty, 1992-2014. JAMA Intern Med. May 2017;177(5):710-8.

8. Kachalia A et al. Liability claims and costs before and after implementation of a medical error disclosure program. Ann Intern Med. Aug 17 2010;153(4):213-21.
 

Fear of malpractice litigation weighs on many physicians, including hospitalists. Specific concerns that physicians have about facing a malpractice claim include stigmatization, loss of confidence in one’s own clinical skills, and a possible personal financial toll if an award exceeds the limit of one’s malpractice insurance.

Physician worries about malpractice are increasingly being raised during discussions of burnout, with a recent National Academy of Medicine discussion paper listing malpractice concerns as a possible factor that could contribute to physician burnout.¹

Dr. Schaffer is an attending physician in the Hospital Medicine Unit at Brigham and Women’s Hospital, an instructor at Harvard Medical School, and a senior clinical analytics specialist at CRICO/Risk Management Foundation of the Harvard Medical Institutions, all in Boston. Dr. Kachalia is an attending physician in the Hospital Medicine Unit at Brigham and Women’s Hospital, an associate professor at Harvard Medical School, and the chief quality officer at Brigham and Women’s Hospital.

References

1. Dyrbye LN et al. Burnout among health care professionals: A call to explore and address this underrecognized threat to safe, high-quality care. National Academy of Medicine Perspectives. 2017 Jul 5.

2. Helland E et al. Bargaining in the shadow of the website: Disclosure’s impact on medical malpractice litigation. American Law and Economics Review. 2010;12(2):423-61.

3. Bishop TF et al. Physicians’ views on defensive medicine: A national survey. Arch Intern Med. Jun 28 2010;170(12):1081-3.

4. Kachalia A et al. Overuse of testing in preoperative evaluation and syncope: A survey of hospitalists. Ann Intern Med. 2015 Jan 20;162(2):100-8.

5. Schaffer AC et al. Liability impact of the hospitalist model of care. J Hosp Med. Dec 2014;9(12):750-5.

6. CRICO Strategies. Medication-related malpractice risks: 2016 CBS Benchmarking Report. Boston. The Risk Management Foundation of Harvard Medical Institutions; 2016. Available at: www.rmf.harvard.edu/cbsreport (accessed Sept. 14, 2017).

7. Schaffer AC et al. Rates and characteristics of paid malpractice claims among US physicians by specialty, 1992-2014. JAMA Intern Med. May 2017;177(5):710-8.

8. Kachalia A et al. Liability claims and costs before and after implementation of a medical error disclosure program. Ann Intern Med. Aug 17 2010;153(4):213-21.
 

The program committee of the American Heart Association deemed the following four studies the best for the first Late-Breaking Science 1 session at the AHA scientific sessions in Anaheim, exploring solutions to periprocedural dilemmas in coronary artery bypass surgery and electrophysiology.

The session is on Sunday, Nov. 12, 3:45-5:00 p.m. in Hall D.

• TRiCS III: Opening with a transfusion study, C. David Mazer, MD, of St. Michaels Hospital, University of Toronto, will present results of the Transfusion Requirements in Cardiac Surgery (TRiCS) III trial. The international, open-label, randomized noninferiority trial compared two commonly used transfusion strategies in high-risk patients having cardiac surgery. Specifically, it compared a restrictive transfusion strategy in which patients receive a red cell transfusion if their hemoglobin was below 75 g/L intraoperatively and/or postoperatively with a liberal transfusion strategy (where the cutoff for red cell transfusion was 95 g/L intraoperatively), or below 85 g/L postoperatively in the intensive care unit and on the ward. The primary outcome is a composite of any of the following events (up to hospital discharge or postoperative day 28, whichever comes first): all-cause mortality, myocardial infarction, new renal failure, or new focal neurological deficit.
• DACAB: Second in the session is the phase 4 trial to Compare the Efficacy of Different Antiplatelet Therapy Strategy After Coronary Artery Bypass Graft Surgery (DACAB), presented by Qiang Zhao, MD, of Shanghai Jiaotong University. This three-pronged study was designed to show the superiority of ticagrelor alone and ticagrelor plus aspirin over aspirin monotherapy for the 1-year primary efficacy endpoint of vein graft patency.
• PRESERVE: Seeking to reduce complications of angiography, presenter Steven Weisbord, MD, of the University of Pittsburgh, and his colleagues carried out the PRESERVE (Prevention of Serious Adverse Events Following Angiography) trial. It compared the effectiveness of intravenous isotonic sodium bicarbonate with intravenous isotonic sodium chloride and oral N-acetylcysteine with oral placebo for the prevention of serious adverse outcomes following angiographic procedures in high-risk patients. The primary outcome is a composite of serious, adverse, patient-centered events, including death, need for acute dialysis, or persistent decline in kidney function at 90 days.
• BRUISE CONTROL-2: The purpose of this study was to determine the best way to prevent hematoma by managing novel oral anticoagulants (NOACs) at the time of pacemaker or defibrillator surgery. Presenter David H. Birnie, MD, of the University of Ottawa Heart Institute, and his coinvestigators hypothesized that performing device surgery without interruption of the NOAC will result in a reduced rate of clinically significant hematoma. In the trial, called Strategy of Continued Versus Interrupted Novel Oral Anti-coagulant at Time of Device Surgery in Patients With Moderate to High Risk of Arterial Thromboembolic Events (BRUISE CONTROL-2), continued or interrupted anticoagulation with dabigatran, rivaroxaban, and apixaban were compared.
• ABRIDGE J: Presenter Akihiko Nogami, MD, of the University of Tsukuba (Japan), and his coinvestigators aimed to evaluate the efficacy and safety of perioperative anticoagulants during catheter ablation of atrial fibrillation. In the Clinical Benefit of Minimally-Interrupted Dabigatran versus Uninterrupted Warfarin for Catheter Ablation of Atrial Fibrillation (ABRIDGE-J) trial, patients with drug-resistant paroxysmal AF were randomized to receive dabigatran or warfarin perioperatively. The main outcome measures were incidence of embolism during the perioperative period and presence or absence of an intracardiac thrombus just before ablation.

[email protected]

On Twitter @cardionews

The program committee of the American Heart Association deemed the following four studies the best for the first Late-Breaking Science 1 session at the AHA scientific sessions in Anaheim, exploring solutions to periprocedural dilemmas in coronary artery bypass surgery and electrophysiology.

The session is on Sunday, Nov. 12, 3:45-5:00 p.m. in Hall D.

• TRiCS III: Opening with a transfusion study, C. David Mazer, MD, of St. Michaels Hospital, University of Toronto, will present results of the Transfusion Requirements in Cardiac Surgery (TRiCS) III trial. The international, open-label, randomized noninferiority trial compared two commonly used transfusion strategies in high-risk patients having cardiac surgery. Specifically, it compared a restrictive transfusion strategy in which patients receive a red cell transfusion if their hemoglobin was below 75 g/L intraoperatively and/or postoperatively with a liberal transfusion strategy (where the cutoff for red cell transfusion was 95 g/L intraoperatively), or below 85 g/L postoperatively in the intensive care unit and on the ward. The primary outcome is a composite of any of the following events (up to hospital discharge or postoperative day 28, whichever comes first): all-cause mortality, myocardial infarction, new renal failure, or new focal neurological deficit.
• DACAB: Second in the session is the phase 4 trial to Compare the Efficacy of Different Antiplatelet Therapy Strategy After Coronary Artery Bypass Graft Surgery (DACAB), presented by Qiang Zhao, MD, of Shanghai Jiaotong University. This three-pronged study was designed to show the superiority of ticagrelor alone and ticagrelor plus aspirin over aspirin monotherapy for the 1-year primary efficacy endpoint of vein graft patency.
• PRESERVE: Seeking to reduce complications of angiography, presenter Steven Weisbord, MD, of the University of Pittsburgh, and his colleagues carried out the PRESERVE (Prevention of Serious Adverse Events Following Angiography) trial. It compared the effectiveness of intravenous isotonic sodium bicarbonate with intravenous isotonic sodium chloride and oral N-acetylcysteine with oral placebo for the prevention of serious adverse outcomes following angiographic procedures in high-risk patients. The primary outcome is a composite of serious, adverse, patient-centered events, including death, need for acute dialysis, or persistent decline in kidney function at 90 days.
• BRUISE CONTROL-2: The purpose of this study was to determine the best way to prevent hematoma by managing novel oral anticoagulants (NOACs) at the time of pacemaker or defibrillator surgery. Presenter David H. Birnie, MD, of the University of Ottawa Heart Institute, and his coinvestigators hypothesized that performing device surgery without interruption of the NOAC will result in a reduced rate of clinically significant hematoma. In the trial, called Strategy of Continued Versus Interrupted Novel Oral Anti-coagulant at Time of Device Surgery in Patients With Moderate to High Risk of Arterial Thromboembolic Events (BRUISE CONTROL-2), continued or interrupted anticoagulation with dabigatran, rivaroxaban, and apixaban were compared.
• ABRIDGE J: Presenter Akihiko Nogami, MD, of the University of Tsukuba (Japan), and his coinvestigators aimed to evaluate the efficacy and safety of perioperative anticoagulants during catheter ablation of atrial fibrillation. In the Clinical Benefit of Minimally-Interrupted Dabigatran versus Uninterrupted Warfarin for Catheter Ablation of Atrial Fibrillation (ABRIDGE-J) trial, patients with drug-resistant paroxysmal AF were randomized to receive dabigatran or warfarin perioperatively. The main outcome measures were incidence of embolism during the perioperative period and presence or absence of an intracardiac thrombus just before ablation.

[email protected]

On Twitter @cardionews

The program committee of the American Heart Association deemed the following four studies the best for the first Late-Breaking Science 1 session at the AHA scientific sessions in Anaheim, exploring solutions to periprocedural dilemmas in coronary artery bypass surgery and electrophysiology.

The session is on Sunday, Nov. 12, 3:45-5:00 p.m. in Hall D.

• TRiCS III: Opening with a transfusion study, C. David Mazer, MD, of St. Michaels Hospital, University of Toronto, will present results of the Transfusion Requirements in Cardiac Surgery (TRiCS) III trial. The international, open-label, randomized noninferiority trial compared two commonly used transfusion strategies in high-risk patients having cardiac surgery. Specifically, it compared a restrictive transfusion strategy in which patients receive a red cell transfusion if their hemoglobin was below 75 g/L intraoperatively and/or postoperatively with a liberal transfusion strategy (where the cutoff for red cell transfusion was 95 g/L intraoperatively), or below 85 g/L postoperatively in the intensive care unit and on the ward. The primary outcome is a composite of any of the following events (up to hospital discharge or postoperative day 28, whichever comes first): all-cause mortality, myocardial infarction, new renal failure, or new focal neurological deficit.
• DACAB: Second in the session is the phase 4 trial to Compare the Efficacy of Different Antiplatelet Therapy Strategy After Coronary Artery Bypass Graft Surgery (DACAB), presented by Qiang Zhao, MD, of Shanghai Jiaotong University. This three-pronged study was designed to show the superiority of ticagrelor alone and ticagrelor plus aspirin over aspirin monotherapy for the 1-year primary efficacy endpoint of vein graft patency.
• PRESERVE: Seeking to reduce complications of angiography, presenter Steven Weisbord, MD, of the University of Pittsburgh, and his colleagues carried out the PRESERVE (Prevention of Serious Adverse Events Following Angiography) trial. It compared the effectiveness of intravenous isotonic sodium bicarbonate with intravenous isotonic sodium chloride and oral N-acetylcysteine with oral placebo for the prevention of serious adverse outcomes following angiographic procedures in high-risk patients. The primary outcome is a composite of serious, adverse, patient-centered events, including death, need for acute dialysis, or persistent decline in kidney function at 90 days.
• BRUISE CONTROL-2: The purpose of this study was to determine the best way to prevent hematoma by managing novel oral anticoagulants (NOACs) at the time of pacemaker or defibrillator surgery. Presenter David H. Birnie, MD, of the University of Ottawa Heart Institute, and his coinvestigators hypothesized that performing device surgery without interruption of the NOAC will result in a reduced rate of clinically significant hematoma. In the trial, called Strategy of Continued Versus Interrupted Novel Oral Anti-coagulant at Time of Device Surgery in Patients With Moderate to High Risk of Arterial Thromboembolic Events (BRUISE CONTROL-2), continued or interrupted anticoagulation with dabigatran, rivaroxaban, and apixaban were compared.
• ABRIDGE J: Presenter Akihiko Nogami, MD, of the University of Tsukuba (Japan), and his coinvestigators aimed to evaluate the efficacy and safety of perioperative anticoagulants during catheter ablation of atrial fibrillation. In the Clinical Benefit of Minimally-Interrupted Dabigatran versus Uninterrupted Warfarin for Catheter Ablation of Atrial Fibrillation (ABRIDGE-J) trial, patients with drug-resistant paroxysmal AF were randomized to receive dabigatran or warfarin perioperatively. The main outcome measures were incidence of embolism during the perioperative period and presence or absence of an intracardiac thrombus just before ablation.

[email protected]

On Twitter @cardionews

SAN DIEGO – For the first time, a forthcoming evidence-based guideline for the management of psoriatic arthritis recommends tumor necrosis factor inhibitor biologics as first-line therapy.

“Guidelines that have been around for the last several years have been skirting around the fact that there’s really no evidence that methotrexate works for PsA,” Dafna D. Gladman, MD, said during a press briefing at the annual meeting of the American College of Rheumatology. “So it’s refreshing and reassuring that when you do an appropriate, evidence-based approach, you finally find the truth in front of you, and you have TNF inhibitors as the first-line treatment. Obviously, they’re not for everybody. There are patients in whom we cannot use TNF inhibitors, either because they don’t like needles, or because they have contraindications to getting these particular needles, but at least we have a recommendation for the use of these drugs as a first-line treatment.”

Doug Brunk/Frontline Medical News

[email protected]

SAN DIEGO – For the first time, a forthcoming evidence-based guideline for the management of psoriatic arthritis recommends tumor necrosis factor inhibitor biologics as first-line therapy.

“Guidelines that have been around for the last several years have been skirting around the fact that there’s really no evidence that methotrexate works for PsA,” Dafna D. Gladman, MD, said during a press briefing at the annual meeting of the American College of Rheumatology. “So it’s refreshing and reassuring that when you do an appropriate, evidence-based approach, you finally find the truth in front of you, and you have TNF inhibitors as the first-line treatment. Obviously, they’re not for everybody. There are patients in whom we cannot use TNF inhibitors, either because they don’t like needles, or because they have contraindications to getting these particular needles, but at least we have a recommendation for the use of these drugs as a first-line treatment.”

Doug Brunk/Frontline Medical News

[email protected]

SAN DIEGO – For the first time, a forthcoming evidence-based guideline for the management of psoriatic arthritis recommends tumor necrosis factor inhibitor biologics as first-line therapy.

“Guidelines that have been around for the last several years have been skirting around the fact that there’s really no evidence that methotrexate works for PsA,” Dafna D. Gladman, MD, said during a press briefing at the annual meeting of the American College of Rheumatology. “So it’s refreshing and reassuring that when you do an appropriate, evidence-based approach, you finally find the truth in front of you, and you have TNF inhibitors as the first-line treatment. Obviously, they’re not for everybody. There are patients in whom we cannot use TNF inhibitors, either because they don’t like needles, or because they have contraindications to getting these particular needles, but at least we have a recommendation for the use of these drugs as a first-line treatment.”

Doug Brunk/Frontline Medical News

[email protected]

NATIONAL HARBOR, MD. – When combined with bariatric surgery, adjunctive therapies for obesity should be individualized for specific drivers of weight gain, which can differ among obesity phenotypes, according to an expert view presented at an annual meeting presented by the American Society for Metabolic and Bariatric Surgery and The Obesity Society .

“Surgery is the most effective therapy we have, but it is only one of multiple treatments that should be considered in a treatment paradigm,” suggested Robert F. Kushner, MD, a professor of endocrinology and specialist in obesity at the Northwestern University, Chicago.

Ted Bosworth

NATIONAL HARBOR, MD. – When combined with bariatric surgery, adjunctive therapies for obesity should be individualized for specific drivers of weight gain, which can differ among obesity phenotypes, according to an expert view presented at an annual meeting presented by the American Society for Metabolic and Bariatric Surgery and The Obesity Society .

“Surgery is the most effective therapy we have, but it is only one of multiple treatments that should be considered in a treatment paradigm,” suggested Robert F. Kushner, MD, a professor of endocrinology and specialist in obesity at the Northwestern University, Chicago.

Ted Bosworth

NATIONAL HARBOR, MD. – When combined with bariatric surgery, adjunctive therapies for obesity should be individualized for specific drivers of weight gain, which can differ among obesity phenotypes, according to an expert view presented at an annual meeting presented by the American Society for Metabolic and Bariatric Surgery and The Obesity Society .

“Surgery is the most effective therapy we have, but it is only one of multiple treatments that should be considered in a treatment paradigm,” suggested Robert F. Kushner, MD, a professor of endocrinology and specialist in obesity at the Northwestern University, Chicago.

Ted Bosworth

President Trump recently announced his decision to officially end the Deferred Action for Childhood Arrivals program, also known as DACA. The program has been controversial since its inception, almost as controversial as the decision to end it. What impact has DACA had on the medical community, including hospitalists, and what are the implications of ending it?

DACA is a program started in 2012 by an executive action under the Obama administration. The program currently protects approximately 800,000 undocumented immigrants in the United States from being deported. All DACA recipients were brought to this country illegally as children. When the DACA program began, in order to enroll, recipients had to prove that they had arrived to here before age 16, and that they had been living in the United States continuously since 2007. Once enrolled, the protections they receive from the program include the ability to legally work and to go to school, as well as obtain a social security number and driver’s license. These protections are then afforded for renewable 2-year periods of time.¹

• No new applications will be accepted.
• All existing permits will be honored until they expire.
• All applications in process will continue to be processed.

They contend that no current DACA recipients will be affected before March 2018. Unfortunately for the Trump administration, this has been a very unpopular move, as two-thirds of Americans support allowing the Dreamers to stay in the United States.¹

Impact on health care

The concern for the medical industry is that a “dismantling” of DACA could exacerbate an already existing physician shortage in the United States. For example, the Association of American Medical Colleges estimates the physician shortage will rise as the population ages and medical access increases; they currently estimate a physician shortage of approximately 40,000-104,000 by 2030.

Wikimedia Commons/Seattle City Council/ CCO Attribution 2.0 Generic

• The Bridge Act, which effectively extends the present DACA program by 3 years.
• Recognizing America’s Children Act, which would allow people who meet DACA eligibility criteria to apply for conditional permanent residence with a path toward citizenship.
• The American Hope Act and updated DREAM Act, both of which propose broader eligibility criteria and faster pathways to citizenship.⁴

There is great hope that some definitive action can be employed by Congress, as most legislators on both sides of the aisle have expressed some support for at least one of the proposed policies (although that certainly does not guarantee sufficient votes to pass). There also is support from many Americans, given that most DACA recipients have been productive members of society, and most Americans believe that DACA recipients should not be held accountable “for the sins of their parents.”⁴

It appears that the dismantling of DACA would be quite unsettling and certainly would affect some areas of the country more severely than others. Regardless of political stance, everyone can agree that Congress needs to do something, as the ambiguity and uncertainty caused by a million undocumented immigrants living and working in the United States cannot be ignored or indefinitely deferred. Any of the above options that offer a pathway to citizenship would be welcomed by most Americans. Having Dreamers in limbo is bad for everyone; the time to act is now.
 

Dr. Scheurer is a hospitalist and chief quality officer at the Medical University of South Carolina in Charleston. She is physician editor of The Hospitalist. Email her at [email protected].

References

1. http://www.npr.org/2017/09/05/548754723/5-things-you-should-know-about-daca

2. https://www.forbes.com/sites/brucejapsen/2017/09/05/how-trumps-move-to-end-daca-worsens-the-doctor-shortage/#5143320d5b06

3. http://www.chicagomag.com/city-life/September-2017/DACA-Stritch-Medical-School/

4. http://www.nejm.org/doi/full/10.1056/NEJMp1711416?query=TOC
 

President Trump recently announced his decision to officially end the Deferred Action for Childhood Arrivals program, also known as DACA. The program has been controversial since its inception, almost as controversial as the decision to end it. What impact has DACA had on the medical community, including hospitalists, and what are the implications of ending it?

DACA is a program started in 2012 by an executive action under the Obama administration. The program currently protects approximately 800,000 undocumented immigrants in the United States from being deported. All DACA recipients were brought to this country illegally as children. When the DACA program began, in order to enroll, recipients had to prove that they had arrived to here before age 16, and that they had been living in the United States continuously since 2007. Once enrolled, the protections they receive from the program include the ability to legally work and to go to school, as well as obtain a social security number and driver’s license. These protections are then afforded for renewable 2-year periods of time.¹

• No new applications will be accepted.
• All existing permits will be honored until they expire.
• All applications in process will continue to be processed.

They contend that no current DACA recipients will be affected before March 2018. Unfortunately for the Trump administration, this has been a very unpopular move, as two-thirds of Americans support allowing the Dreamers to stay in the United States.¹

Impact on health care

The concern for the medical industry is that a “dismantling” of DACA could exacerbate an already existing physician shortage in the United States. For example, the Association of American Medical Colleges estimates the physician shortage will rise as the population ages and medical access increases; they currently estimate a physician shortage of approximately 40,000-104,000 by 2030.

Wikimedia Commons/Seattle City Council/ CCO Attribution 2.0 Generic

• The Bridge Act, which effectively extends the present DACA program by 3 years.
• Recognizing America’s Children Act, which would allow people who meet DACA eligibility criteria to apply for conditional permanent residence with a path toward citizenship.
• The American Hope Act and updated DREAM Act, both of which propose broader eligibility criteria and faster pathways to citizenship.⁴

There is great hope that some definitive action can be employed by Congress, as most legislators on both sides of the aisle have expressed some support for at least one of the proposed policies (although that certainly does not guarantee sufficient votes to pass). There also is support from many Americans, given that most DACA recipients have been productive members of society, and most Americans believe that DACA recipients should not be held accountable “for the sins of their parents.”⁴

It appears that the dismantling of DACA would be quite unsettling and certainly would affect some areas of the country more severely than others. Regardless of political stance, everyone can agree that Congress needs to do something, as the ambiguity and uncertainty caused by a million undocumented immigrants living and working in the United States cannot be ignored or indefinitely deferred. Any of the above options that offer a pathway to citizenship would be welcomed by most Americans. Having Dreamers in limbo is bad for everyone; the time to act is now.
 

Dr. Scheurer is a hospitalist and chief quality officer at the Medical University of South Carolina in Charleston. She is physician editor of The Hospitalist. Email her at [email protected].

References

1. http://www.npr.org/2017/09/05/548754723/5-things-you-should-know-about-daca

2. https://www.forbes.com/sites/brucejapsen/2017/09/05/how-trumps-move-to-end-daca-worsens-the-doctor-shortage/#5143320d5b06

3. http://www.chicagomag.com/city-life/September-2017/DACA-Stritch-Medical-School/

4. http://www.nejm.org/doi/full/10.1056/NEJMp1711416?query=TOC
 

President Trump recently announced his decision to officially end the Deferred Action for Childhood Arrivals program, also known as DACA. The program has been controversial since its inception, almost as controversial as the decision to end it. What impact has DACA had on the medical community, including hospitalists, and what are the implications of ending it?

DACA is a program started in 2012 by an executive action under the Obama administration. The program currently protects approximately 800,000 undocumented immigrants in the United States from being deported. All DACA recipients were brought to this country illegally as children. When the DACA program began, in order to enroll, recipients had to prove that they had arrived to here before age 16, and that they had been living in the United States continuously since 2007. Once enrolled, the protections they receive from the program include the ability to legally work and to go to school, as well as obtain a social security number and driver’s license. These protections are then afforded for renewable 2-year periods of time.¹

• No new applications will be accepted.
• All existing permits will be honored until they expire.
• All applications in process will continue to be processed.

They contend that no current DACA recipients will be affected before March 2018. Unfortunately for the Trump administration, this has been a very unpopular move, as two-thirds of Americans support allowing the Dreamers to stay in the United States.¹

Impact on health care

The concern for the medical industry is that a “dismantling” of DACA could exacerbate an already existing physician shortage in the United States. For example, the Association of American Medical Colleges estimates the physician shortage will rise as the population ages and medical access increases; they currently estimate a physician shortage of approximately 40,000-104,000 by 2030.

Wikimedia Commons/Seattle City Council/ CCO Attribution 2.0 Generic

• The Bridge Act, which effectively extends the present DACA program by 3 years.
• Recognizing America’s Children Act, which would allow people who meet DACA eligibility criteria to apply for conditional permanent residence with a path toward citizenship.
• The American Hope Act and updated DREAM Act, both of which propose broader eligibility criteria and faster pathways to citizenship.⁴

There is great hope that some definitive action can be employed by Congress, as most legislators on both sides of the aisle have expressed some support for at least one of the proposed policies (although that certainly does not guarantee sufficient votes to pass). There also is support from many Americans, given that most DACA recipients have been productive members of society, and most Americans believe that DACA recipients should not be held accountable “for the sins of their parents.”⁴

It appears that the dismantling of DACA would be quite unsettling and certainly would affect some areas of the country more severely than others. Regardless of political stance, everyone can agree that Congress needs to do something, as the ambiguity and uncertainty caused by a million undocumented immigrants living and working in the United States cannot be ignored or indefinitely deferred. Any of the above options that offer a pathway to citizenship would be welcomed by most Americans. Having Dreamers in limbo is bad for everyone; the time to act is now.
 

Dr. Scheurer is a hospitalist and chief quality officer at the Medical University of South Carolina in Charleston. She is physician editor of The Hospitalist. Email her at [email protected].

References

1. http://www.npr.org/2017/09/05/548754723/5-things-you-should-know-about-daca

2. https://www.forbes.com/sites/brucejapsen/2017/09/05/how-trumps-move-to-end-daca-worsens-the-doctor-shortage/#5143320d5b06

3. http://www.chicagomag.com/city-life/September-2017/DACA-Stritch-Medical-School/

4. http://www.nejm.org/doi/full/10.1056/NEJMp1711416?query=TOC
 

BOSTON – Amyloid imaging with the PET agent florbetaben changed the clinical management of 80% of dementia patients with a complicated or uncertain presentation, Mathieu Ceccaldi, MD, reported at the Clinical Trials on Alzheimer’s Disease conference.

The French real-world study also found that 51% of the patients had a medication change after their amyloid imaging study, said Dr. Ceccaldi, a neurologist at the Timone Hospital in Marseille, France.

“In daily practice, we are sometimes faced with complex presentations and diagnostic uncertainty in patients who have early onset dementia, atypical nonamnestic dementia, unusual behavioral symptoms, or an unexpected rate of progression,” he said. “Amyloid imaging can help resolve those issues.”

The results echo – and even exceed – those returned in an interim analysis of the large U.S.-based Imaging Dementia–Evidence for Amyloid Scanning study. The IDEAS study is examining how amyloid imaging with the PET agent florbetapir may change clinical management of dementia patients. According to data presented at last summer’s Alzheimer’s Association International Conference, knowledge of patients’ brain amyloid status changed clinical management in 68% of cases.

In France, as in the United States, amyloid imaging is not routinely available outside of clinical research programs. French patients normally undergo a lumbar puncture (LP) to obtain amyloid biomarkers. However, if an LP isn’t feasible because of the patient’s clinical condition, it’s attempted and fails, the patient refuses, or the results are unclear, then imaging may be employed.

Dr. Ceccaldi’s study comprised 205 such patients seen in any of 18 memory clinics for dementia of uncertain etiology. The study evaluated how often amyloid PET imaging with florbetaben changed the patient’s diagnosis or management and how often it contributed to improving diagnostic uncertainty.

The patients were a mean of 71 years old, with a mean Mini-Mental State Exam score of 22. An LP had been performed in 42%, but those results were either ambiguous or inconsistent with the patient’s clinical presentation. Other patients (37%) refused the procedure, and the rest had a medical contraindication to LP or had a failed procedure.

The most common diagnosis at baseline was Alzheimer’s dementia (72%), which included typical and atypical sporadic AD, young-onset AD, and rapidly progressing AD. In 16% of the cohort, the diagnosis was non-Alzheimer’s dementia, including frontotemporal dementia, primary progressive aphasia, Lewy body dementia, corticobasal degeneration, semantic dementia, and Parkinson’s disease dementia. The diagnosis was mixed dementia in 8% and nonneurodegenerative dementia in the remainder – a catchall that included vascular dementia, psychiatric disorders, and other forms of dementia.

Imaging determined that 73 patients were amyloid negative and that 132 patients were amyloid positive. These results changed diagnosis in 67% of cases overall, in 58% of amyloid-positive patients, and in 84% of amyloid-negative patients.

In the absence of cerebrospinal fluid data, florbetaben imaging significantly improved diagnostic confidence in 81% of the entire cohort (167 patients). Before imaging, clinicians rated fewer than 5% of their diagnoses as very highly confident; this rose to nearly 100% after imaging. Similarly, before imaging, about 40% of clinicians said they had weak confidence in their initial diagnoses; this dropped to fewer than 5% after imaging.

Of the 67% with a changed diagnosis (137 patients), 76 were amyloid positive, and 61 were amyloid negative. Positive scans reclassified 18 patients as having AD; negative scans removed an AD diagnosis for 38 patients.

AD was the most commonly altered diagnosis, dropping from 72% to 62% of the entire cohort. The proportion of those with non-AD dementia increased from 16% before imaging to 18% after. Mixed dementias decreased from 8% to 5%, and the number diagnosed with nonneurodegenerative dementias increased from 5% to 17%.

In particular, Dr. Ceccaldi noted, the number of patients with potentially treatable nonneurodegenerative dementia rose from 10 to 35. These included revised diagnoses for those with psychiatric disorders (from 3 patients before imaging to 11 patients after), vascular dementias (from 2 to 8 patients), and other treatable causes of dementia (from 5 to 16 patients).

All of these altered diagnoses changed management in 80% of both positive and negative patients. Among these changes were the addition of a new medication (50% of amyloid-positive patients, 18% of amyloid-negative patients), the withdrawal of a medication (15% of amyloid-negative cases), additional testing (5% of amyloid-positive cases, 20% of amyloid-negative cases), and referral to another specialist (5% of amyloid-positive patients, 20% of amyloid-negative patients).

“Our results highlight the significant utility of amyloid PET for patients with complex dementia presentations in the context of the existing work-up,” Dr. Ceccaldi said.

He reported financial relationships with a number of pharmaceutical companies, including Piramal, which developed and manufactures florbetaben.

[email protected]

On Twitter @alz_gal

BOSTON – Amyloid imaging with the PET agent florbetaben changed the clinical management of 80% of dementia patients with a complicated or uncertain presentation, Mathieu Ceccaldi, MD, reported at the Clinical Trials on Alzheimer’s Disease conference.

The French real-world study also found that 51% of the patients had a medication change after their amyloid imaging study, said Dr. Ceccaldi, a neurologist at the Timone Hospital in Marseille, France.

“In daily practice, we are sometimes faced with complex presentations and diagnostic uncertainty in patients who have early onset dementia, atypical nonamnestic dementia, unusual behavioral symptoms, or an unexpected rate of progression,” he said. “Amyloid imaging can help resolve those issues.”

The results echo – and even exceed – those returned in an interim analysis of the large U.S.-based Imaging Dementia–Evidence for Amyloid Scanning study. The IDEAS study is examining how amyloid imaging with the PET agent florbetapir may change clinical management of dementia patients. According to data presented at last summer’s Alzheimer’s Association International Conference, knowledge of patients’ brain amyloid status changed clinical management in 68% of cases.

In France, as in the United States, amyloid imaging is not routinely available outside of clinical research programs. French patients normally undergo a lumbar puncture (LP) to obtain amyloid biomarkers. However, if an LP isn’t feasible because of the patient’s clinical condition, it’s attempted and fails, the patient refuses, or the results are unclear, then imaging may be employed.

Dr. Ceccaldi’s study comprised 205 such patients seen in any of 18 memory clinics for dementia of uncertain etiology. The study evaluated how often amyloid PET imaging with florbetaben changed the patient’s diagnosis or management and how often it contributed to improving diagnostic uncertainty.

The patients were a mean of 71 years old, with a mean Mini-Mental State Exam score of 22. An LP had been performed in 42%, but those results were either ambiguous or inconsistent with the patient’s clinical presentation. Other patients (37%) refused the procedure, and the rest had a medical contraindication to LP or had a failed procedure.

The most common diagnosis at baseline was Alzheimer’s dementia (72%), which included typical and atypical sporadic AD, young-onset AD, and rapidly progressing AD. In 16% of the cohort, the diagnosis was non-Alzheimer’s dementia, including frontotemporal dementia, primary progressive aphasia, Lewy body dementia, corticobasal degeneration, semantic dementia, and Parkinson’s disease dementia. The diagnosis was mixed dementia in 8% and nonneurodegenerative dementia in the remainder – a catchall that included vascular dementia, psychiatric disorders, and other forms of dementia.

Imaging determined that 73 patients were amyloid negative and that 132 patients were amyloid positive. These results changed diagnosis in 67% of cases overall, in 58% of amyloid-positive patients, and in 84% of amyloid-negative patients.

In the absence of cerebrospinal fluid data, florbetaben imaging significantly improved diagnostic confidence in 81% of the entire cohort (167 patients). Before imaging, clinicians rated fewer than 5% of their diagnoses as very highly confident; this rose to nearly 100% after imaging. Similarly, before imaging, about 40% of clinicians said they had weak confidence in their initial diagnoses; this dropped to fewer than 5% after imaging.

Of the 67% with a changed diagnosis (137 patients), 76 were amyloid positive, and 61 were amyloid negative. Positive scans reclassified 18 patients as having AD; negative scans removed an AD diagnosis for 38 patients.

AD was the most commonly altered diagnosis, dropping from 72% to 62% of the entire cohort. The proportion of those with non-AD dementia increased from 16% before imaging to 18% after. Mixed dementias decreased from 8% to 5%, and the number diagnosed with nonneurodegenerative dementias increased from 5% to 17%.

In particular, Dr. Ceccaldi noted, the number of patients with potentially treatable nonneurodegenerative dementia rose from 10 to 35. These included revised diagnoses for those with psychiatric disorders (from 3 patients before imaging to 11 patients after), vascular dementias (from 2 to 8 patients), and other treatable causes of dementia (from 5 to 16 patients).

All of these altered diagnoses changed management in 80% of both positive and negative patients. Among these changes were the addition of a new medication (50% of amyloid-positive patients, 18% of amyloid-negative patients), the withdrawal of a medication (15% of amyloid-negative cases), additional testing (5% of amyloid-positive cases, 20% of amyloid-negative cases), and referral to another specialist (5% of amyloid-positive patients, 20% of amyloid-negative patients).

“Our results highlight the significant utility of amyloid PET for patients with complex dementia presentations in the context of the existing work-up,” Dr. Ceccaldi said.

He reported financial relationships with a number of pharmaceutical companies, including Piramal, which developed and manufactures florbetaben.

[email protected]

On Twitter @alz_gal

BOSTON – Amyloid imaging with the PET agent florbetaben changed the clinical management of 80% of dementia patients with a complicated or uncertain presentation, Mathieu Ceccaldi, MD, reported at the Clinical Trials on Alzheimer’s Disease conference.

The French real-world study also found that 51% of the patients had a medication change after their amyloid imaging study, said Dr. Ceccaldi, a neurologist at the Timone Hospital in Marseille, France.

“In daily practice, we are sometimes faced with complex presentations and diagnostic uncertainty in patients who have early onset dementia, atypical nonamnestic dementia, unusual behavioral symptoms, or an unexpected rate of progression,” he said. “Amyloid imaging can help resolve those issues.”

The results echo – and even exceed – those returned in an interim analysis of the large U.S.-based Imaging Dementia–Evidence for Amyloid Scanning study. The IDEAS study is examining how amyloid imaging with the PET agent florbetapir may change clinical management of dementia patients. According to data presented at last summer’s Alzheimer’s Association International Conference, knowledge of patients’ brain amyloid status changed clinical management in 68% of cases.

In France, as in the United States, amyloid imaging is not routinely available outside of clinical research programs. French patients normally undergo a lumbar puncture (LP) to obtain amyloid biomarkers. However, if an LP isn’t feasible because of the patient’s clinical condition, it’s attempted and fails, the patient refuses, or the results are unclear, then imaging may be employed.

Dr. Ceccaldi’s study comprised 205 such patients seen in any of 18 memory clinics for dementia of uncertain etiology. The study evaluated how often amyloid PET imaging with florbetaben changed the patient’s diagnosis or management and how often it contributed to improving diagnostic uncertainty.

The patients were a mean of 71 years old, with a mean Mini-Mental State Exam score of 22. An LP had been performed in 42%, but those results were either ambiguous or inconsistent with the patient’s clinical presentation. Other patients (37%) refused the procedure, and the rest had a medical contraindication to LP or had a failed procedure.

The most common diagnosis at baseline was Alzheimer’s dementia (72%), which included typical and atypical sporadic AD, young-onset AD, and rapidly progressing AD. In 16% of the cohort, the diagnosis was non-Alzheimer’s dementia, including frontotemporal dementia, primary progressive aphasia, Lewy body dementia, corticobasal degeneration, semantic dementia, and Parkinson’s disease dementia. The diagnosis was mixed dementia in 8% and nonneurodegenerative dementia in the remainder – a catchall that included vascular dementia, psychiatric disorders, and other forms of dementia.

Imaging determined that 73 patients were amyloid negative and that 132 patients were amyloid positive. These results changed diagnosis in 67% of cases overall, in 58% of amyloid-positive patients, and in 84% of amyloid-negative patients.

In the absence of cerebrospinal fluid data, florbetaben imaging significantly improved diagnostic confidence in 81% of the entire cohort (167 patients). Before imaging, clinicians rated fewer than 5% of their diagnoses as very highly confident; this rose to nearly 100% after imaging. Similarly, before imaging, about 40% of clinicians said they had weak confidence in their initial diagnoses; this dropped to fewer than 5% after imaging.

Of the 67% with a changed diagnosis (137 patients), 76 were amyloid positive, and 61 were amyloid negative. Positive scans reclassified 18 patients as having AD; negative scans removed an AD diagnosis for 38 patients.

AD was the most commonly altered diagnosis, dropping from 72% to 62% of the entire cohort. The proportion of those with non-AD dementia increased from 16% before imaging to 18% after. Mixed dementias decreased from 8% to 5%, and the number diagnosed with nonneurodegenerative dementias increased from 5% to 17%.

In particular, Dr. Ceccaldi noted, the number of patients with potentially treatable nonneurodegenerative dementia rose from 10 to 35. These included revised diagnoses for those with psychiatric disorders (from 3 patients before imaging to 11 patients after), vascular dementias (from 2 to 8 patients), and other treatable causes of dementia (from 5 to 16 patients).

All of these altered diagnoses changed management in 80% of both positive and negative patients. Among these changes were the addition of a new medication (50% of amyloid-positive patients, 18% of amyloid-negative patients), the withdrawal of a medication (15% of amyloid-negative cases), additional testing (5% of amyloid-positive cases, 20% of amyloid-negative cases), and referral to another specialist (5% of amyloid-positive patients, 20% of amyloid-negative patients).

“Our results highlight the significant utility of amyloid PET for patients with complex dementia presentations in the context of the existing work-up,” Dr. Ceccaldi said.

He reported financial relationships with a number of pharmaceutical companies, including Piramal, which developed and manufactures florbetaben.

[email protected]

On Twitter @alz_gal