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Smaller, intrapericardial LVAD noninferior to HeartMate II
A smaller, centrifugal-flow left ventricular assist device that lies entirely within the pericardial space was found noninferior to the HeartMate II axial-flow device in patients with advanced heart failure who weren’t eligible for heart transplant, according to a report published online Feb. 2 in the New England Journal of Medicine.
The two LVADs were compared in ENDURANCE (A Clinical Trial to Evaluate the HeartWare Ventricular Assist System), a prospective, randomized trial in 445 patients who were treated at 48 U.S. sites and followed for 2 years. The study participants had an LV ejection fraction of 25% or less and high prevalences of abnormal renal function and dependence on intravenous inotropic support, said Joseph G. Rogers, MD, of Duke University, Durham, N.C., and his associates.
The study participants were randomly assigned to receive the HeartWare, an investigational centrifugal-flow LVAD (297 patients) or the standard axial-flow HeartMate II LVAD (148 patients). In the intention-to-treat analysis, the primary endpoint – a composite of survival free from disabling stroke and no removal of the device for malfunction or failure – was 55.4% with the new device and 59.1% in the control group. The results were similar in the per-protocol and the as-treated analyses, demonstrating that the new device was noninferior but not superior to the axial-flow LVAD, the investigators said (N Engl J Med. 2017 Feb 2. doi: 10.1056/NEJMoa1602954).
There were significantly more cases of device malfunction or failure requiring urgent surgery in the control group than in the centrifugal-flow group (16.2% vs 8.8%), but significantly more cases of stroke (29.7% vs 12.1%), sepsis, and right heart failure. Rates of major bleeding, cardiac arrhythmia, renal dysfunction, and infection were similar between the two study groups. Overall survival* also was not significantly different (60.2% with the new LVAD and 67.6% in the control group).
Both study groups showed significant and comparable improvement after LVAD implantation. Functional status improved to New York Heart Association class I or II in roughly 80% of patients. Mean 6-minute walk distance improved from 100.2 to 199.4 meters with the new device and from 91.9 to 190.1 meters in the control group, a change that was noted within 3 months of surgery and persisted through the end of follow-up. Similarly, mean scores on the Kansas City Cardiomyopathy Questionnaire improved by 25.8 points and 25.3 points, respectively, and mean scores on the European Quality of Life 5 Dimensions scale improved by 22.5 points and 25.5 points, respectively.
This trial was sponsored by HeartWare, which was also involved in data management and analysis. Dr. Rogers reported having no relevant financial disclosures; his associates reported ties to HeartWare (Medtronic), Thoratec (St. Jude Medical), Novartis, and GE HealthCare.
*Correction 2/2/17: An earlier version of this article misidentified survival rates as mortality rates.
The smaller, fully intrapericardial, centrifugal-flow LVAD met one of its goals: Compared with the existing LVAD, it significantly reduced the need for urgent reoperation due to device malfunction or failure.
However, it did not resolve some of the most important problems with LVAD support. It didn’t reduce stroke risk; in fact, the overall risk of stroke was higher with the new device. It also failed to reduce the risk of bleeding, sepsis, or right heart failure.
It appears that no LVAD is fully superior to the others.
Roland Hetzer, MD, PhD, and Eva M. Delmo Walter, MD, PhD, of Cardio Centrum in Berlin, made these remarks in an accompanying editorial (N Engl J Med. 2017 Feb 2. doi: 10.1056/NEJMe1613755). They reported having no relevant financial disclosures.
The smaller, fully intrapericardial, centrifugal-flow LVAD met one of its goals: Compared with the existing LVAD, it significantly reduced the need for urgent reoperation due to device malfunction or failure.
However, it did not resolve some of the most important problems with LVAD support. It didn’t reduce stroke risk; in fact, the overall risk of stroke was higher with the new device. It also failed to reduce the risk of bleeding, sepsis, or right heart failure.
It appears that no LVAD is fully superior to the others.
Roland Hetzer, MD, PhD, and Eva M. Delmo Walter, MD, PhD, of Cardio Centrum in Berlin, made these remarks in an accompanying editorial (N Engl J Med. 2017 Feb 2. doi: 10.1056/NEJMe1613755). They reported having no relevant financial disclosures.
The smaller, fully intrapericardial, centrifugal-flow LVAD met one of its goals: Compared with the existing LVAD, it significantly reduced the need for urgent reoperation due to device malfunction or failure.
However, it did not resolve some of the most important problems with LVAD support. It didn’t reduce stroke risk; in fact, the overall risk of stroke was higher with the new device. It also failed to reduce the risk of bleeding, sepsis, or right heart failure.
It appears that no LVAD is fully superior to the others.
Roland Hetzer, MD, PhD, and Eva M. Delmo Walter, MD, PhD, of Cardio Centrum in Berlin, made these remarks in an accompanying editorial (N Engl J Med. 2017 Feb 2. doi: 10.1056/NEJMe1613755). They reported having no relevant financial disclosures.
A smaller, centrifugal-flow left ventricular assist device that lies entirely within the pericardial space was found noninferior to the HeartMate II axial-flow device in patients with advanced heart failure who weren’t eligible for heart transplant, according to a report published online Feb. 2 in the New England Journal of Medicine.
The two LVADs were compared in ENDURANCE (A Clinical Trial to Evaluate the HeartWare Ventricular Assist System), a prospective, randomized trial in 445 patients who were treated at 48 U.S. sites and followed for 2 years. The study participants had an LV ejection fraction of 25% or less and high prevalences of abnormal renal function and dependence on intravenous inotropic support, said Joseph G. Rogers, MD, of Duke University, Durham, N.C., and his associates.
The study participants were randomly assigned to receive the HeartWare, an investigational centrifugal-flow LVAD (297 patients) or the standard axial-flow HeartMate II LVAD (148 patients). In the intention-to-treat analysis, the primary endpoint – a composite of survival free from disabling stroke and no removal of the device for malfunction or failure – was 55.4% with the new device and 59.1% in the control group. The results were similar in the per-protocol and the as-treated analyses, demonstrating that the new device was noninferior but not superior to the axial-flow LVAD, the investigators said (N Engl J Med. 2017 Feb 2. doi: 10.1056/NEJMoa1602954).
There were significantly more cases of device malfunction or failure requiring urgent surgery in the control group than in the centrifugal-flow group (16.2% vs 8.8%), but significantly more cases of stroke (29.7% vs 12.1%), sepsis, and right heart failure. Rates of major bleeding, cardiac arrhythmia, renal dysfunction, and infection were similar between the two study groups. Overall survival* also was not significantly different (60.2% with the new LVAD and 67.6% in the control group).
Both study groups showed significant and comparable improvement after LVAD implantation. Functional status improved to New York Heart Association class I or II in roughly 80% of patients. Mean 6-minute walk distance improved from 100.2 to 199.4 meters with the new device and from 91.9 to 190.1 meters in the control group, a change that was noted within 3 months of surgery and persisted through the end of follow-up. Similarly, mean scores on the Kansas City Cardiomyopathy Questionnaire improved by 25.8 points and 25.3 points, respectively, and mean scores on the European Quality of Life 5 Dimensions scale improved by 22.5 points and 25.5 points, respectively.
This trial was sponsored by HeartWare, which was also involved in data management and analysis. Dr. Rogers reported having no relevant financial disclosures; his associates reported ties to HeartWare (Medtronic), Thoratec (St. Jude Medical), Novartis, and GE HealthCare.
*Correction 2/2/17: An earlier version of this article misidentified survival rates as mortality rates.
A smaller, centrifugal-flow left ventricular assist device that lies entirely within the pericardial space was found noninferior to the HeartMate II axial-flow device in patients with advanced heart failure who weren’t eligible for heart transplant, according to a report published online Feb. 2 in the New England Journal of Medicine.
The two LVADs were compared in ENDURANCE (A Clinical Trial to Evaluate the HeartWare Ventricular Assist System), a prospective, randomized trial in 445 patients who were treated at 48 U.S. sites and followed for 2 years. The study participants had an LV ejection fraction of 25% or less and high prevalences of abnormal renal function and dependence on intravenous inotropic support, said Joseph G. Rogers, MD, of Duke University, Durham, N.C., and his associates.
The study participants were randomly assigned to receive the HeartWare, an investigational centrifugal-flow LVAD (297 patients) or the standard axial-flow HeartMate II LVAD (148 patients). In the intention-to-treat analysis, the primary endpoint – a composite of survival free from disabling stroke and no removal of the device for malfunction or failure – was 55.4% with the new device and 59.1% in the control group. The results were similar in the per-protocol and the as-treated analyses, demonstrating that the new device was noninferior but not superior to the axial-flow LVAD, the investigators said (N Engl J Med. 2017 Feb 2. doi: 10.1056/NEJMoa1602954).
There were significantly more cases of device malfunction or failure requiring urgent surgery in the control group than in the centrifugal-flow group (16.2% vs 8.8%), but significantly more cases of stroke (29.7% vs 12.1%), sepsis, and right heart failure. Rates of major bleeding, cardiac arrhythmia, renal dysfunction, and infection were similar between the two study groups. Overall survival* also was not significantly different (60.2% with the new LVAD and 67.6% in the control group).
Both study groups showed significant and comparable improvement after LVAD implantation. Functional status improved to New York Heart Association class I or II in roughly 80% of patients. Mean 6-minute walk distance improved from 100.2 to 199.4 meters with the new device and from 91.9 to 190.1 meters in the control group, a change that was noted within 3 months of surgery and persisted through the end of follow-up. Similarly, mean scores on the Kansas City Cardiomyopathy Questionnaire improved by 25.8 points and 25.3 points, respectively, and mean scores on the European Quality of Life 5 Dimensions scale improved by 22.5 points and 25.5 points, respectively.
This trial was sponsored by HeartWare, which was also involved in data management and analysis. Dr. Rogers reported having no relevant financial disclosures; his associates reported ties to HeartWare (Medtronic), Thoratec (St. Jude Medical), Novartis, and GE HealthCare.
*Correction 2/2/17: An earlier version of this article misidentified survival rates as mortality rates.
FROM THE NEW ENGLAND JOURNAL OF MEDICINE
Key clinical point: A smaller, centrifugal-flow left ventricular assist device was found noninferior to the existing FDA-approved axial-flow device in patients with advanced heart failure who weren’t eligible for heart transplant.
Major finding: The primary endpoint – a composite of survival free from disabling stroke and no removal of the device for malfunction or failure – was 55.4% with the new device and 59.1% in the control group.
Data source: ENDURANCE, a prospective multicenter randomized trial in 445 patients followed for 2 years.
Disclosures: This trial was sponsored by HeartWare, which was also involved in data management and analysis. Dr. Rogers reported having no relevant financial disclosures; his associates reported ties to HeartWare (Medtronic), Thoratec (St. Jude Medical), Novartis, and GE HealthCare.
SAVR an option for elderly with aortic stenosis
HOUSTON – Surgical aortic valve replacement can be performed in intermediate-risk elderly patients with an operative mortality rate of 4.1%, which is better than expected, according to results from a large multicenter analysis. However, the rate of in-hospital stroke was 5.4% – twice what was expected.
“This is most likely secondary to neurologic assessment [that was conducted] for all patients postoperatively,” Vinod H. Thourani, MD, said at the annual meeting of the Society of Thoracic Surgeons.
The findings come from an in-depth analysis of SAVR outcomes in patients who participated in the Placement of Aortic Transcatheter Valves trial, known as PARTNER 2A. Conducted from December 2011 to November 2013, PARTNER 2A evaluated 2,032 medium-risk patients with aortic stenosis who were randomized to SAVR or transcatheter aortic valve replacement (TAVR) in 57 North American centers and found no significant difference in the 2-year rate of death or disabling stroke (N Engl J Med. 2016 Apr 28;3749[17]:1609-20).
Dr. Thourani’s analysis focused on the 937 patients who underwent SAVR. The main objectives were to describe operative mortality and hospital morbidities compared with STS benchmarks, describe time-related mortality and stroke including preoperative predictors for these outcomes, evaluate the effect of concomitant procedures on mortality and hospital morbidities, and evaluate longitudinal valve performance after SAVR.
The average age of these patients was 82 years, 45% were female, and their mean STS risk score was 5.8. In addition, 26% had prior coronary artery bypass surgery, 10% had a previous stroke, and 12% had previous pacemaker placement. Of the 30% of patients with chronic obstructive pulmonary disease, 9.6% were oxygen dependent going into the operating room, reported Dr. Thourani, one of the PARTNER 2A investigators, and a cardiothoracic surgeon at Emory University, Atlanta.
Most of the patients (85%) had a full sternotomy, while 15% had a mini sternotomy. Isolated AVR was done in 79% of patients, 15% of patients had AVR plus CABG, and 6% had AVR and other concomitant procedures. The mean coronary bypass time for isolated AVR was 98 minutes, and rose to a mean of 129 minutes when a concomitant procedure was added. The mean cross-clamp time was 69 minutes, and rose to a mean of 95 minutes when a concomitant procedure was added.
The investigators observed that all-cause operative mortality was 4.1%, which is lower than STS predicted-risk models. At the same time, mortality for AVR plus a concomitant procedure was 5%, followed by isolated AVR (4.2%) and AVR plus CABG plus a concomitant procedure (2.9%). The rate of in-hospital stroke was 5.4% and the rate of in-hospital deep sternal wound infection was 0.8%. At 2 years postoperatively, mortality was 17% among those who underwent isolated AVR, 18% among those who underwent AVR plus CABG, and 21% among those who underwent AVR plus a concomitant procedure, differences that did not reach statistical significance. The rate of stroke at 2 years also was similar between groups: 12% among those who underwent isolated AVR, 11% in those who underwent AVR plus a concomitant procedure, and 8.2% in those who underwent AVR plus CABG.
The main risk factor for early death after SAVR was longer procedure time (P less than .0001), while risk factors for later deaths included cachexia (P = .02), lower ejection fraction (P = .01), higher creatinine (P = .03), coronary artery disease (P = .03), and smaller prostheses (P = .01)
Dr. Thourani and his associates also found that 33% of patients had severe prosthesis-patient mismatch, yet they had survival rates similar to the rates of those without severe prosthesis-patient mismatch.
“From this adjudicated, prospectively collected data in the contemporary era, SAVR can be performed in intermediate-risk elderly patients with mortality commensurate with national benchmarks,” he concluded. “Continued surveillance of these patients remains extremely important.”
Dr. Thourani disclosed that he is a consultant for and has received research support from Edwards Lifesciences. Other authors of the study reported having numerous relevant financial disclosures.
This analysis of the surgical arm of the PARTNER 2A trial reveals respectable outcome for those so-called intermediaterisk patients with severe symptomatic aortic stenosis. The fact that mortality at 2 years was similar between the surgical and the catheter arm of the trial (upward of 17%), speaks of the multiple comorbidities present in these patients (N Engl J Med. 
This analysis of the surgical arm of the PARTNER 2A trial reveals respectable outcome for those so-called intermediaterisk patients with severe symptomatic aortic stenosis. The fact that mortality at 2 years was similar between the surgical and the catheter arm of the trial (upward of 17%), speaks of the multiple comorbidities present in these patients (N Engl J Med.
This analysis of the surgical arm of the PARTNER 2A trial reveals respectable outcome for those so-called intermediaterisk patients with severe symptomatic aortic stenosis. The fact that mortality at 2 years was similar between the surgical and the catheter arm of the trial (upward of 17%), speaks of the multiple comorbidities present in these patients (N Engl J Med.
HOUSTON – Surgical aortic valve replacement can be performed in intermediate-risk elderly patients with an operative mortality rate of 4.1%, which is better than expected, according to results from a large multicenter analysis. However, the rate of in-hospital stroke was 5.4% – twice what was expected.
“This is most likely secondary to neurologic assessment [that was conducted] for all patients postoperatively,” Vinod H. Thourani, MD, said at the annual meeting of the Society of Thoracic Surgeons.
The findings come from an in-depth analysis of SAVR outcomes in patients who participated in the Placement of Aortic Transcatheter Valves trial, known as PARTNER 2A. Conducted from December 2011 to November 2013, PARTNER 2A evaluated 2,032 medium-risk patients with aortic stenosis who were randomized to SAVR or transcatheter aortic valve replacement (TAVR) in 57 North American centers and found no significant difference in the 2-year rate of death or disabling stroke (N Engl J Med. 2016 Apr 28;3749[17]:1609-20).
Dr. Thourani’s analysis focused on the 937 patients who underwent SAVR. The main objectives were to describe operative mortality and hospital morbidities compared with STS benchmarks, describe time-related mortality and stroke including preoperative predictors for these outcomes, evaluate the effect of concomitant procedures on mortality and hospital morbidities, and evaluate longitudinal valve performance after SAVR.
The average age of these patients was 82 years, 45% were female, and their mean STS risk score was 5.8. In addition, 26% had prior coronary artery bypass surgery, 10% had a previous stroke, and 12% had previous pacemaker placement. Of the 30% of patients with chronic obstructive pulmonary disease, 9.6% were oxygen dependent going into the operating room, reported Dr. Thourani, one of the PARTNER 2A investigators, and a cardiothoracic surgeon at Emory University, Atlanta.
Most of the patients (85%) had a full sternotomy, while 15% had a mini sternotomy. Isolated AVR was done in 79% of patients, 15% of patients had AVR plus CABG, and 6% had AVR and other concomitant procedures. The mean coronary bypass time for isolated AVR was 98 minutes, and rose to a mean of 129 minutes when a concomitant procedure was added. The mean cross-clamp time was 69 minutes, and rose to a mean of 95 minutes when a concomitant procedure was added.
The investigators observed that all-cause operative mortality was 4.1%, which is lower than STS predicted-risk models. At the same time, mortality for AVR plus a concomitant procedure was 5%, followed by isolated AVR (4.2%) and AVR plus CABG plus a concomitant procedure (2.9%). The rate of in-hospital stroke was 5.4% and the rate of in-hospital deep sternal wound infection was 0.8%. At 2 years postoperatively, mortality was 17% among those who underwent isolated AVR, 18% among those who underwent AVR plus CABG, and 21% among those who underwent AVR plus a concomitant procedure, differences that did not reach statistical significance. The rate of stroke at 2 years also was similar between groups: 12% among those who underwent isolated AVR, 11% in those who underwent AVR plus a concomitant procedure, and 8.2% in those who underwent AVR plus CABG.
The main risk factor for early death after SAVR was longer procedure time (P less than .0001), while risk factors for later deaths included cachexia (P = .02), lower ejection fraction (P = .01), higher creatinine (P = .03), coronary artery disease (P = .03), and smaller prostheses (P = .01)
Dr. Thourani and his associates also found that 33% of patients had severe prosthesis-patient mismatch, yet they had survival rates similar to the rates of those without severe prosthesis-patient mismatch.
“From this adjudicated, prospectively collected data in the contemporary era, SAVR can be performed in intermediate-risk elderly patients with mortality commensurate with national benchmarks,” he concluded. “Continued surveillance of these patients remains extremely important.”
Dr. Thourani disclosed that he is a consultant for and has received research support from Edwards Lifesciences. Other authors of the study reported having numerous relevant financial disclosures.
HOUSTON – Surgical aortic valve replacement can be performed in intermediate-risk elderly patients with an operative mortality rate of 4.1%, which is better than expected, according to results from a large multicenter analysis. However, the rate of in-hospital stroke was 5.4% – twice what was expected.
“This is most likely secondary to neurologic assessment [that was conducted] for all patients postoperatively,” Vinod H. Thourani, MD, said at the annual meeting of the Society of Thoracic Surgeons.
The findings come from an in-depth analysis of SAVR outcomes in patients who participated in the Placement of Aortic Transcatheter Valves trial, known as PARTNER 2A. Conducted from December 2011 to November 2013, PARTNER 2A evaluated 2,032 medium-risk patients with aortic stenosis who were randomized to SAVR or transcatheter aortic valve replacement (TAVR) in 57 North American centers and found no significant difference in the 2-year rate of death or disabling stroke (N Engl J Med. 2016 Apr 28;3749[17]:1609-20).
Dr. Thourani’s analysis focused on the 937 patients who underwent SAVR. The main objectives were to describe operative mortality and hospital morbidities compared with STS benchmarks, describe time-related mortality and stroke including preoperative predictors for these outcomes, evaluate the effect of concomitant procedures on mortality and hospital morbidities, and evaluate longitudinal valve performance after SAVR.
The average age of these patients was 82 years, 45% were female, and their mean STS risk score was 5.8. In addition, 26% had prior coronary artery bypass surgery, 10% had a previous stroke, and 12% had previous pacemaker placement. Of the 30% of patients with chronic obstructive pulmonary disease, 9.6% were oxygen dependent going into the operating room, reported Dr. Thourani, one of the PARTNER 2A investigators, and a cardiothoracic surgeon at Emory University, Atlanta.
Most of the patients (85%) had a full sternotomy, while 15% had a mini sternotomy. Isolated AVR was done in 79% of patients, 15% of patients had AVR plus CABG, and 6% had AVR and other concomitant procedures. The mean coronary bypass time for isolated AVR was 98 minutes, and rose to a mean of 129 minutes when a concomitant procedure was added. The mean cross-clamp time was 69 minutes, and rose to a mean of 95 minutes when a concomitant procedure was added.
The investigators observed that all-cause operative mortality was 4.1%, which is lower than STS predicted-risk models. At the same time, mortality for AVR plus a concomitant procedure was 5%, followed by isolated AVR (4.2%) and AVR plus CABG plus a concomitant procedure (2.9%). The rate of in-hospital stroke was 5.4% and the rate of in-hospital deep sternal wound infection was 0.8%. At 2 years postoperatively, mortality was 17% among those who underwent isolated AVR, 18% among those who underwent AVR plus CABG, and 21% among those who underwent AVR plus a concomitant procedure, differences that did not reach statistical significance. The rate of stroke at 2 years also was similar between groups: 12% among those who underwent isolated AVR, 11% in those who underwent AVR plus a concomitant procedure, and 8.2% in those who underwent AVR plus CABG.
The main risk factor for early death after SAVR was longer procedure time (P less than .0001), while risk factors for later deaths included cachexia (P = .02), lower ejection fraction (P = .01), higher creatinine (P = .03), coronary artery disease (P = .03), and smaller prostheses (P = .01)
Dr. Thourani and his associates also found that 33% of patients had severe prosthesis-patient mismatch, yet they had survival rates similar to the rates of those without severe prosthesis-patient mismatch.
“From this adjudicated, prospectively collected data in the contemporary era, SAVR can be performed in intermediate-risk elderly patients with mortality commensurate with national benchmarks,” he concluded. “Continued surveillance of these patients remains extremely important.”
Dr. Thourani disclosed that he is a consultant for and has received research support from Edwards Lifesciences. Other authors of the study reported having numerous relevant financial disclosures.
AT THE STS ANNUAL MEETING
Key clinical point:
Major finding: All-cause operative mortality was 4.1%, which is lower than STS predicted risk models.
Data source: A study of 937 medium-risk patients with aortic stenosis who were randomized to SAVR in the PARTNER 2A trial.
Disclosures: Dr. Thourani is a consultant for and has received research support from Edwards Lifesciences. Other authors of the study reported having numerous relevant financial disclosures.
STICHES boosts CABG role in severe LV dysfunction
SNOWMASS, COLO. – Coronary artery bypass graft surgery in patients with severe ischemic left ventricular dysfunction is overdue for an upgrade in status in the American College of Cardiology/American Heart Association guidelines on the strength of the landmark STICH trial and its extended follow-up stage known as STICHES, according to Vinod H. Thourani, MD.
Currently, the guidelines give CABG in this large and growing population a class IIb recommendation, meaning it “might be considered.” This undervalues the study’s core lesson: “STICHES showed a clear survival benefit with CABG, so this most likely should become a class IIa recommendation,” Dr. Thourani said at the Annual Cardiovascular Conference at Snowmass.
He went on to describe how he applies the key study findings to individual patients.
At 5 and 10 years of follow-up, the probability of all-cause mortality was reduced by 14% and 16%, respectively, in the CABG group. The surgery provided on average an 18-month extension of life. The price paid for the CABG benefit was a 3.6% mortality rate at 30 days; however, this was overcome by the 2-year mark, at which point survival in the CABG group surpassed that in controls. Thereafter, the all-cause mortality gap between the two groups continued to widen for the duration of follow-up.
For the composite endpoint of all-cause mortality or cardiovascular hospitalization, the CABG group enjoyed a 26% relative risk reduction, compared with optimal medical management alone at 5 years, and a 28% reduction in risk at 10 years. The two study groups diverged in terms of risk of cardiovascular hospitalization after only 3 months.
CABG provided a reduction in the risk of cardiovascular death that was consistent across all ages. In contrast, the reduction in all-cause mortality was not, since a higher proportion of deaths in older patients came from cancer and other noncardiovascular causes (Circulation. 2016 Nov 1;134[18]:1314-24).
There have been no randomized, controlled trials of percutaneous coronary intervention in patients with heart failure.
“An interesting finding in STICHES was that medical therapy had a much higher 10-year all-cause mortality the younger the patient was. So CABG particularly benefits those who are at a younger age – in this study, age 60 or less. As you get older, say, at 80 years of age, I’m not sure there’s a huge benefit in all-cause mortality at that point,” said Dr. Thourani, professor of surgery and medicine, and codirector of the structural heart and valve center at Emory University in Atlanta.
In a STICH substudy, roughly half of participants underwent presurgical myocardial viability testing via single-photon emission CT and/or dobutamine echocardiography. The investigators found that the results didn’t predict mortality benefit for CABG (N Engl J Med. 2011 Apr 28;364[17]:1617-25).
More recently, however, other investigators have reported MRI to have prognostic value. For example, Belgian investigators showed that medical therapy in patients with ischemic heart failure and dysfunctional but viable myocardium on delayed-enhanced MRI was associated with a 4.56-fold increased likelihood of mortality during 3 years of follow-up, compared with complete revascularization via CABG (J Am Coll Cardiol. 2012 Feb 28;59[9]:825-35).
“This observation has been useful for me,” Dr. Thourani said. “My own personal practice is if I have good targets, I don’t do viability testing, but if I have really bad targets where I know I’m going to have a tough time sewing grafts, I try to get an MRI for viability testing.”
One important lesson of STICH is that all patients with heart failure and a low left ventricular ejection fraction should have a coronary angiogram, even if they are free of ischemia on noninvasive testing and have no angina. That’s because the patients enrolled in STICH had little or no angina, the surgeon continued.
These STICH-type patients will benefit greatly from a heart team assessment factoring in an individual’s Society of Thoracic Surgeons’ predicted risk score, based on age, comorbidities, and other factors. For example, if a patient’s STS risk score with CABG is 0.7%, that’s a strong argument for opting for the surgery, since the 30-day operative mortality in STICH was 3.6%. If, on the other hand, the STS score is greater than 7%, that’s a tougher call.
“I think it’s really important that a heart team assessment includes a noninvasive cardiologist as well as an interventional cardiologist and cardiac surgeon because I think interventionalists and cardiac surgeons sometimes get a little goofy in their assessment of these patients,” Dr. Thourani said.
Patients with a low ejection fraction and coronary artery disease who are deemed poor candidates for CABG should be evaluated for a mechanical circulatory support device or a heart transplant.
“I think that’s something we don’t think about enough, quite honestly,” he said.
Dr. Thourani reported serving as a consultant to Abbott Vascular, Edwards Lifesciences, and Gore, and receiving research grants from numerous companies.
SNOWMASS, COLO. – Coronary artery bypass graft surgery in patients with severe ischemic left ventricular dysfunction is overdue for an upgrade in status in the American College of Cardiology/American Heart Association guidelines on the strength of the landmark STICH trial and its extended follow-up stage known as STICHES, according to Vinod H. Thourani, MD.
Currently, the guidelines give CABG in this large and growing population a class IIb recommendation, meaning it “might be considered.” This undervalues the study’s core lesson: “STICHES showed a clear survival benefit with CABG, so this most likely should become a class IIa recommendation,” Dr. Thourani said at the Annual Cardiovascular Conference at Snowmass.
He went on to describe how he applies the key study findings to individual patients.
At 5 and 10 years of follow-up, the probability of all-cause mortality was reduced by 14% and 16%, respectively, in the CABG group. The surgery provided on average an 18-month extension of life. The price paid for the CABG benefit was a 3.6% mortality rate at 30 days; however, this was overcome by the 2-year mark, at which point survival in the CABG group surpassed that in controls. Thereafter, the all-cause mortality gap between the two groups continued to widen for the duration of follow-up.
For the composite endpoint of all-cause mortality or cardiovascular hospitalization, the CABG group enjoyed a 26% relative risk reduction, compared with optimal medical management alone at 5 years, and a 28% reduction in risk at 10 years. The two study groups diverged in terms of risk of cardiovascular hospitalization after only 3 months.
CABG provided a reduction in the risk of cardiovascular death that was consistent across all ages. In contrast, the reduction in all-cause mortality was not, since a higher proportion of deaths in older patients came from cancer and other noncardiovascular causes (Circulation. 2016 Nov 1;134[18]:1314-24).
There have been no randomized, controlled trials of percutaneous coronary intervention in patients with heart failure.
“An interesting finding in STICHES was that medical therapy had a much higher 10-year all-cause mortality the younger the patient was. So CABG particularly benefits those who are at a younger age – in this study, age 60 or less. As you get older, say, at 80 years of age, I’m not sure there’s a huge benefit in all-cause mortality at that point,” said Dr. Thourani, professor of surgery and medicine, and codirector of the structural heart and valve center at Emory University in Atlanta.
In a STICH substudy, roughly half of participants underwent presurgical myocardial viability testing via single-photon emission CT and/or dobutamine echocardiography. The investigators found that the results didn’t predict mortality benefit for CABG (N Engl J Med. 2011 Apr 28;364[17]:1617-25).
More recently, however, other investigators have reported MRI to have prognostic value. For example, Belgian investigators showed that medical therapy in patients with ischemic heart failure and dysfunctional but viable myocardium on delayed-enhanced MRI was associated with a 4.56-fold increased likelihood of mortality during 3 years of follow-up, compared with complete revascularization via CABG (J Am Coll Cardiol. 2012 Feb 28;59[9]:825-35).
“This observation has been useful for me,” Dr. Thourani said. “My own personal practice is if I have good targets, I don’t do viability testing, but if I have really bad targets where I know I’m going to have a tough time sewing grafts, I try to get an MRI for viability testing.”
One important lesson of STICH is that all patients with heart failure and a low left ventricular ejection fraction should have a coronary angiogram, even if they are free of ischemia on noninvasive testing and have no angina. That’s because the patients enrolled in STICH had little or no angina, the surgeon continued.
These STICH-type patients will benefit greatly from a heart team assessment factoring in an individual’s Society of Thoracic Surgeons’ predicted risk score, based on age, comorbidities, and other factors. For example, if a patient’s STS risk score with CABG is 0.7%, that’s a strong argument for opting for the surgery, since the 30-day operative mortality in STICH was 3.6%. If, on the other hand, the STS score is greater than 7%, that’s a tougher call.
“I think it’s really important that a heart team assessment includes a noninvasive cardiologist as well as an interventional cardiologist and cardiac surgeon because I think interventionalists and cardiac surgeons sometimes get a little goofy in their assessment of these patients,” Dr. Thourani said.
Patients with a low ejection fraction and coronary artery disease who are deemed poor candidates for CABG should be evaluated for a mechanical circulatory support device or a heart transplant.
“I think that’s something we don’t think about enough, quite honestly,” he said.
Dr. Thourani reported serving as a consultant to Abbott Vascular, Edwards Lifesciences, and Gore, and receiving research grants from numerous companies.
SNOWMASS, COLO. – Coronary artery bypass graft surgery in patients with severe ischemic left ventricular dysfunction is overdue for an upgrade in status in the American College of Cardiology/American Heart Association guidelines on the strength of the landmark STICH trial and its extended follow-up stage known as STICHES, according to Vinod H. Thourani, MD.
Currently, the guidelines give CABG in this large and growing population a class IIb recommendation, meaning it “might be considered.” This undervalues the study’s core lesson: “STICHES showed a clear survival benefit with CABG, so this most likely should become a class IIa recommendation,” Dr. Thourani said at the Annual Cardiovascular Conference at Snowmass.
He went on to describe how he applies the key study findings to individual patients.
At 5 and 10 years of follow-up, the probability of all-cause mortality was reduced by 14% and 16%, respectively, in the CABG group. The surgery provided on average an 18-month extension of life. The price paid for the CABG benefit was a 3.6% mortality rate at 30 days; however, this was overcome by the 2-year mark, at which point survival in the CABG group surpassed that in controls. Thereafter, the all-cause mortality gap between the two groups continued to widen for the duration of follow-up.
For the composite endpoint of all-cause mortality or cardiovascular hospitalization, the CABG group enjoyed a 26% relative risk reduction, compared with optimal medical management alone at 5 years, and a 28% reduction in risk at 10 years. The two study groups diverged in terms of risk of cardiovascular hospitalization after only 3 months.
CABG provided a reduction in the risk of cardiovascular death that was consistent across all ages. In contrast, the reduction in all-cause mortality was not, since a higher proportion of deaths in older patients came from cancer and other noncardiovascular causes (Circulation. 2016 Nov 1;134[18]:1314-24).
There have been no randomized, controlled trials of percutaneous coronary intervention in patients with heart failure.
“An interesting finding in STICHES was that medical therapy had a much higher 10-year all-cause mortality the younger the patient was. So CABG particularly benefits those who are at a younger age – in this study, age 60 or less. As you get older, say, at 80 years of age, I’m not sure there’s a huge benefit in all-cause mortality at that point,” said Dr. Thourani, professor of surgery and medicine, and codirector of the structural heart and valve center at Emory University in Atlanta.
In a STICH substudy, roughly half of participants underwent presurgical myocardial viability testing via single-photon emission CT and/or dobutamine echocardiography. The investigators found that the results didn’t predict mortality benefit for CABG (N Engl J Med. 2011 Apr 28;364[17]:1617-25).
More recently, however, other investigators have reported MRI to have prognostic value. For example, Belgian investigators showed that medical therapy in patients with ischemic heart failure and dysfunctional but viable myocardium on delayed-enhanced MRI was associated with a 4.56-fold increased likelihood of mortality during 3 years of follow-up, compared with complete revascularization via CABG (J Am Coll Cardiol. 2012 Feb 28;59[9]:825-35).
“This observation has been useful for me,” Dr. Thourani said. “My own personal practice is if I have good targets, I don’t do viability testing, but if I have really bad targets where I know I’m going to have a tough time sewing grafts, I try to get an MRI for viability testing.”
One important lesson of STICH is that all patients with heart failure and a low left ventricular ejection fraction should have a coronary angiogram, even if they are free of ischemia on noninvasive testing and have no angina. That’s because the patients enrolled in STICH had little or no angina, the surgeon continued.
These STICH-type patients will benefit greatly from a heart team assessment factoring in an individual’s Society of Thoracic Surgeons’ predicted risk score, based on age, comorbidities, and other factors. For example, if a patient’s STS risk score with CABG is 0.7%, that’s a strong argument for opting for the surgery, since the 30-day operative mortality in STICH was 3.6%. If, on the other hand, the STS score is greater than 7%, that’s a tougher call.
“I think it’s really important that a heart team assessment includes a noninvasive cardiologist as well as an interventional cardiologist and cardiac surgeon because I think interventionalists and cardiac surgeons sometimes get a little goofy in their assessment of these patients,” Dr. Thourani said.
Patients with a low ejection fraction and coronary artery disease who are deemed poor candidates for CABG should be evaluated for a mechanical circulatory support device or a heart transplant.
“I think that’s something we don’t think about enough, quite honestly,” he said.
Dr. Thourani reported serving as a consultant to Abbott Vascular, Edwards Lifesciences, and Gore, and receiving research grants from numerous companies.
EXPERT ANALYSIS AT THE CARDIOVASCULAR CONFERENCE AT SNOWMASS
Clinicians underusing statins, aspirin in HIV patients
NEW ORLEANS – Clinicians may not be prescribing enough statins and/or aspirin therapy for the HIV-infected population at highest risk for atherosclerotic cardiovascular disease, according to the results of a large retrospective study from an HIV clinic in New York.
“We need to shift our paradigm for care – from ‘take antiretrovirals and that’s it’ – to a focus on the whole patient and chronic conditions,” Emma Kaplan-Lewis, MD, said during a poster presentation at an annual scientific meeting on infectious diseases. Risk of cardiovascular events increases 1.5-fold among people with HIV treated with antiretroviral therapy, compared with the uninfected population, she noted.
The investigators examined prescriptions for a statin or aspirin therapy in three high-risk groups, defined by 2013 American College of Cardiology/American Heart Association guidelines and 2011 AHA/American College of Cardiology Foundation guidelines. They classified patients with an ICD-9 code indicating a history of atherosclerotic cardiovascular disease, 40- to 75-year-olds with diabetes and LDL cholesterol greater than 70 mg/dL, and those with an LDL cholesterol level greater than 190 mg/dL.
Almost two-thirds of the higher-risk patients, 141 (61%), had a history of atherosclerotic cardiovascular disease. In this cohort, 56% were prescribed statin therapy, and 100 (71%) were prescribed aspirin.
Of the 85 high-risk patients with diabetes and an LDL greater than 70 mg/dL, 48 (57%) were on statin therapy (aspirin not indicated), and of the 5 high-risk patients with an LDL cholesterol level greater than 190 mg/dL, 3 (60%) were on statin therapy, and 1 (20%) was on aspirin.
The investigators also found 37% of the higher-risk patients were active cigarette smokers. There was a trend toward lower statin use among smokers, 33% versus 44% for nonsmokers. “Smoking was not significantly associated with statin prescription, but this is a modifiable risk factor – after which they may not need a statin,” Dr. Kaplan-Lewis said.
The findings support risk-reduction interventions for people with HIV infection who are at higher risk for cardiovascular disease, Dr. Kaplan-Lewis said. The results support previous reports in the literature, including a study that found 51% of 13,579 veterans infected with HIV had an indication for statin use, but 22% of this group was not prescribed the therapy (Clin Infect Dis. 2016;63:407-13. doi: 10.1093/cid/ciw289).
In 2017, the investigators plan to share the study data with providers. “Each provider will get a list of their patients who should be on a statin. This is about awareness and making it more of a priority,” Dr. Kaplan-Lewis said at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.
The findings of additional research assessing lower thresholds for statin use among people with HIV infection are still pending, Dr. Kaplan-Lewis added.
The study was supported in part by the New York State Department of Health Empire Clinical Research Investigator Program. Dr. Kaplan-Lewis had no relevant disclosures.
NEW ORLEANS – Clinicians may not be prescribing enough statins and/or aspirin therapy for the HIV-infected population at highest risk for atherosclerotic cardiovascular disease, according to the results of a large retrospective study from an HIV clinic in New York.
“We need to shift our paradigm for care – from ‘take antiretrovirals and that’s it’ – to a focus on the whole patient and chronic conditions,” Emma Kaplan-Lewis, MD, said during a poster presentation at an annual scientific meeting on infectious diseases. Risk of cardiovascular events increases 1.5-fold among people with HIV treated with antiretroviral therapy, compared with the uninfected population, she noted.
The investigators examined prescriptions for a statin or aspirin therapy in three high-risk groups, defined by 2013 American College of Cardiology/American Heart Association guidelines and 2011 AHA/American College of Cardiology Foundation guidelines. They classified patients with an ICD-9 code indicating a history of atherosclerotic cardiovascular disease, 40- to 75-year-olds with diabetes and LDL cholesterol greater than 70 mg/dL, and those with an LDL cholesterol level greater than 190 mg/dL.
Almost two-thirds of the higher-risk patients, 141 (61%), had a history of atherosclerotic cardiovascular disease. In this cohort, 56% were prescribed statin therapy, and 100 (71%) were prescribed aspirin.
Of the 85 high-risk patients with diabetes and an LDL greater than 70 mg/dL, 48 (57%) were on statin therapy (aspirin not indicated), and of the 5 high-risk patients with an LDL cholesterol level greater than 190 mg/dL, 3 (60%) were on statin therapy, and 1 (20%) was on aspirin.
The investigators also found 37% of the higher-risk patients were active cigarette smokers. There was a trend toward lower statin use among smokers, 33% versus 44% for nonsmokers. “Smoking was not significantly associated with statin prescription, but this is a modifiable risk factor – after which they may not need a statin,” Dr. Kaplan-Lewis said.
The findings support risk-reduction interventions for people with HIV infection who are at higher risk for cardiovascular disease, Dr. Kaplan-Lewis said. The results support previous reports in the literature, including a study that found 51% of 13,579 veterans infected with HIV had an indication for statin use, but 22% of this group was not prescribed the therapy (Clin Infect Dis. 2016;63:407-13. doi: 10.1093/cid/ciw289).
In 2017, the investigators plan to share the study data with providers. “Each provider will get a list of their patients who should be on a statin. This is about awareness and making it more of a priority,” Dr. Kaplan-Lewis said at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.
The findings of additional research assessing lower thresholds for statin use among people with HIV infection are still pending, Dr. Kaplan-Lewis added.
The study was supported in part by the New York State Department of Health Empire Clinical Research Investigator Program. Dr. Kaplan-Lewis had no relevant disclosures.
NEW ORLEANS – Clinicians may not be prescribing enough statins and/or aspirin therapy for the HIV-infected population at highest risk for atherosclerotic cardiovascular disease, according to the results of a large retrospective study from an HIV clinic in New York.
“We need to shift our paradigm for care – from ‘take antiretrovirals and that’s it’ – to a focus on the whole patient and chronic conditions,” Emma Kaplan-Lewis, MD, said during a poster presentation at an annual scientific meeting on infectious diseases. Risk of cardiovascular events increases 1.5-fold among people with HIV treated with antiretroviral therapy, compared with the uninfected population, she noted.
The investigators examined prescriptions for a statin or aspirin therapy in three high-risk groups, defined by 2013 American College of Cardiology/American Heart Association guidelines and 2011 AHA/American College of Cardiology Foundation guidelines. They classified patients with an ICD-9 code indicating a history of atherosclerotic cardiovascular disease, 40- to 75-year-olds with diabetes and LDL cholesterol greater than 70 mg/dL, and those with an LDL cholesterol level greater than 190 mg/dL.
Almost two-thirds of the higher-risk patients, 141 (61%), had a history of atherosclerotic cardiovascular disease. In this cohort, 56% were prescribed statin therapy, and 100 (71%) were prescribed aspirin.
Of the 85 high-risk patients with diabetes and an LDL greater than 70 mg/dL, 48 (57%) were on statin therapy (aspirin not indicated), and of the 5 high-risk patients with an LDL cholesterol level greater than 190 mg/dL, 3 (60%) were on statin therapy, and 1 (20%) was on aspirin.
The investigators also found 37% of the higher-risk patients were active cigarette smokers. There was a trend toward lower statin use among smokers, 33% versus 44% for nonsmokers. “Smoking was not significantly associated with statin prescription, but this is a modifiable risk factor – after which they may not need a statin,” Dr. Kaplan-Lewis said.
The findings support risk-reduction interventions for people with HIV infection who are at higher risk for cardiovascular disease, Dr. Kaplan-Lewis said. The results support previous reports in the literature, including a study that found 51% of 13,579 veterans infected with HIV had an indication for statin use, but 22% of this group was not prescribed the therapy (Clin Infect Dis. 2016;63:407-13. doi: 10.1093/cid/ciw289).
In 2017, the investigators plan to share the study data with providers. “Each provider will get a list of their patients who should be on a statin. This is about awareness and making it more of a priority,” Dr. Kaplan-Lewis said at the combined annual meetings of the Infectious Diseases Society of America, the Society for Healthcare Epidemiology of America, the HIV Medicine Association, and the Pediatric Infectious Diseases Society.
The findings of additional research assessing lower thresholds for statin use among people with HIV infection are still pending, Dr. Kaplan-Lewis added.
The study was supported in part by the New York State Department of Health Empire Clinical Research Investigator Program. Dr. Kaplan-Lewis had no relevant disclosures.
AT IDWEEK 2016
Key clinical point: Statins and aspirin therapy are underutilized in a proportion of the HIV positive population at higher risk for cardiovascular disease.
Major finding: Of the 141 high-risk people with HIV infection and a history of atherosclerotic cardiovascular disease, only 56% were prescribed a statin and 71% were prescribed aspirin.
Data source: Poster presentation at IDWeek 2016.
Disclosures: The study was supported in part by the New York State Department of Health Empire Clinical Research Investigator Program. Dr. Kaplan-Lewis had no relevant disclosures.
Multivessel PCI in STEMI gains traction
SNOWMASS, COLO. – The tide appears to have turned regarding the merits of percutaneous coronary intervention in non-infarct-related arteries in conjunction with primary PCI for ST-elevation MI in patients with multivessel disease, Douglas E. Drachman, MD, said at the Annual Cardiovascular Conference at Snowmass.
Previously, multivessel PCI in STEMI patients who are hemodynamically stable was believed harmful and was given a Class IIIb recommendation – meaning don’t do it – in the 2013 American College of Cardiology/American Heart Association STEMI guidelines. Just 2 years later, however, new evidence in the form of three randomized trials prompted a focused update of the joint guidelines in which the practice was upgraded to Class IIb status, meaning it could be considered and may be beneficial.
Roughly 50% of STEMI patients have significant lesions in non-infarct-related arteries (non-IRA). The question of how best to treat such patients is an important one because multivessel coronary disease in STEMI is associated with increased risks of both reinfarction and mortality, noted Dr. Drachman, an interventional cardiologist at Massachusetts General Hospital in Boston.
He offered several reasons why the findings of the three influential randomized trials differed from earlier negative retrospective observational studies: “I would argue there’s been significant improvement in our technique in doing PCI. We’re primarily doing transradial interventions now for our patients, so the risk associated with multiple accesses is reduced. Our ability to use more potent antithrombotic strategies is enhanced by our concern about bleeding risk. And the stent platforms that we use in our interventional strategies have improved to the point that we are tackling ever more challenging lesions with greater aplomb and less concern that we may cause harm. I think all these factors have enhanced the ability of the interventionalist to select and treat non-IRAs in a staged fashion and be less parsimonious at the point of care.”
The remaining questions are which non-IRA lesions should be treated, in whom, when relative to primary PCI, and what are the cost implications? These issues are being tackled in at least eight active randomized controlled trials. Depending upon the answers to come, multivessel PCI in STEMI patients could receive a further upgrade in the guidelines.
Since release of the 2015 focused guideline update, several large studies have provided further backing for multivessel PCI in STEMI patients with significant multivessel disease, although these weren’t randomized prospective studies and hence must be considered hypothesis-generating.
One of these major pieces of evidence was a meta-analysis of observational studies led by Eric R. Bates, MD, professor of internal medicine at the University of Michigan in Ann Arbor. He and his coinvestigators analyzed studies comparing culprit vessel-only primary PCI for STEMI patients with multivessel disease versus staged PCI in which primary PCI was done first, followed by PCI of a non-infarct-related vessel later during the same hospitalization or soon after. Staged PCI was the clear winner, with a 2.2-fold greater likelihood of freedom from mortality (J Am Coll Cardiol. 2016 Sep 6;68(10):1066-81).
When the investigators compared studies of staged PCI versus multivessel PCI in the same session as primary PCI, staged PCI was again the clear winner, with a 4-fold greater freedom from mortality.
Among the possible risks of performing PCI of a non-IRA in the same session as primary PCI are increased risks of thrombosis, contrast-induced nephropathy, stent undersizing due to vasospasm, and unintended jeopardy of distant viable myocardium due to microembolization or side branch occlusion, Dr. Drachman said.
“Maybe in certain circumstances it’s best to let the dust settle after the urgent vessel intervention. Wait a couple of days and then make your plan,” the cardiologist advised.
Another informative recent piece of evidence was provided by a Canadian retrospective observational study which compared revascularization strategies in 6,503 consecutive STEMI patients with multivessel disease. Staged multivessel PCI during the index hospitalization was performed in 658 patients, multivessel PCI during the primary PCI session in 1,325, and PCI limited to the infarct-related artery in 4,520. The study endpoints were 2-year all-cause mortality and repeat revascularization.
Staged multivessel PCI had the lowest mortality and repeat revascularization rates. The 2-year mortality rate associated with this strategy was 45% less than with multivessel intervention at the time of primary PCI and 35% lower than for culprit vessel-only PCI, which unsurprisingly had the highest repeat revascularization rate (JACC Cardiovasc Interv. 2017 Jan 9;10(1):11-23).
The first of the three randomized trials that led to a change in the guidelines was the UK PRAMI study (Preventive Angioplasty in Acute Myocardial Infarction). It showed at a mean 23-months followup that STEMI patients with multivessel disease had a 65% reduction in the relative risk of a composite endoint of cardiovascular death, MI, or refractory angina if they received non-IRA PCI at the same time as primary PCI compared with PCI limited to the IRA (N Engl J Med. 2013 Sep 19;369(12):1115-23).
Next came another UK trial: CvLPRIT (Complete vs. Culprit-Lesion Only Primary PCI) demonstrated a 65% reduction in the composite 12-month outcome of all-cause mortality, MI, heart failure, or ischemia-driven PCI with staged PCI during the index hospitalization compared with culprit vessel-only PCI (J Am Coll Cardiol. 2015 Mar 17;65(10):963-72).
Finally, DANAMI-3-PRIMULTI (the Third Danish Study of Optimal Acute Treatment of Patients with STEMI: Primary PCI in Multivessel Disease) showed a dramatic reduction in the risk of ischemia-driven PCI during a median 27 months of followup in patients who underwent staged multivessel PCI guided by the findings of fractional flow reserve measurement compared with primary PCI limited to the IRA (Lancet. 2015 Aug 15;386(9994):665-71). However, fractional flow reserve-guided multivessel PCI didn’t decrease the risk of death or nonfatal recurrent MI, leaving its role unsettled pending the results of ongoing clinical trials.
Dr. Drachman said it’s clear certain STEMI patients should not undergo non-IRA PCI. These include anyone in whom the procedure would be lengthy due to vessel tortuosity or chronic total occlusion, as well as patients with stable saphenous vein graft disease or heavily calcified lesions requiring atherectomy, since multivessel PCI in those settings would pose a high risk for additional left ventricular dysfunction.
“Be thoughtful about patients who have renal dysfunction,” he added.
Dr. Drachman reported having no financial conflicts of interest.
SNOWMASS, COLO. – The tide appears to have turned regarding the merits of percutaneous coronary intervention in non-infarct-related arteries in conjunction with primary PCI for ST-elevation MI in patients with multivessel disease, Douglas E. Drachman, MD, said at the Annual Cardiovascular Conference at Snowmass.
Previously, multivessel PCI in STEMI patients who are hemodynamically stable was believed harmful and was given a Class IIIb recommendation – meaning don’t do it – in the 2013 American College of Cardiology/American Heart Association STEMI guidelines. Just 2 years later, however, new evidence in the form of three randomized trials prompted a focused update of the joint guidelines in which the practice was upgraded to Class IIb status, meaning it could be considered and may be beneficial.
Roughly 50% of STEMI patients have significant lesions in non-infarct-related arteries (non-IRA). The question of how best to treat such patients is an important one because multivessel coronary disease in STEMI is associated with increased risks of both reinfarction and mortality, noted Dr. Drachman, an interventional cardiologist at Massachusetts General Hospital in Boston.
He offered several reasons why the findings of the three influential randomized trials differed from earlier negative retrospective observational studies: “I would argue there’s been significant improvement in our technique in doing PCI. We’re primarily doing transradial interventions now for our patients, so the risk associated with multiple accesses is reduced. Our ability to use more potent antithrombotic strategies is enhanced by our concern about bleeding risk. And the stent platforms that we use in our interventional strategies have improved to the point that we are tackling ever more challenging lesions with greater aplomb and less concern that we may cause harm. I think all these factors have enhanced the ability of the interventionalist to select and treat non-IRAs in a staged fashion and be less parsimonious at the point of care.”
The remaining questions are which non-IRA lesions should be treated, in whom, when relative to primary PCI, and what are the cost implications? These issues are being tackled in at least eight active randomized controlled trials. Depending upon the answers to come, multivessel PCI in STEMI patients could receive a further upgrade in the guidelines.
Since release of the 2015 focused guideline update, several large studies have provided further backing for multivessel PCI in STEMI patients with significant multivessel disease, although these weren’t randomized prospective studies and hence must be considered hypothesis-generating.
One of these major pieces of evidence was a meta-analysis of observational studies led by Eric R. Bates, MD, professor of internal medicine at the University of Michigan in Ann Arbor. He and his coinvestigators analyzed studies comparing culprit vessel-only primary PCI for STEMI patients with multivessel disease versus staged PCI in which primary PCI was done first, followed by PCI of a non-infarct-related vessel later during the same hospitalization or soon after. Staged PCI was the clear winner, with a 2.2-fold greater likelihood of freedom from mortality (J Am Coll Cardiol. 2016 Sep 6;68(10):1066-81).
When the investigators compared studies of staged PCI versus multivessel PCI in the same session as primary PCI, staged PCI was again the clear winner, with a 4-fold greater freedom from mortality.
Among the possible risks of performing PCI of a non-IRA in the same session as primary PCI are increased risks of thrombosis, contrast-induced nephropathy, stent undersizing due to vasospasm, and unintended jeopardy of distant viable myocardium due to microembolization or side branch occlusion, Dr. Drachman said.
“Maybe in certain circumstances it’s best to let the dust settle after the urgent vessel intervention. Wait a couple of days and then make your plan,” the cardiologist advised.
Another informative recent piece of evidence was provided by a Canadian retrospective observational study which compared revascularization strategies in 6,503 consecutive STEMI patients with multivessel disease. Staged multivessel PCI during the index hospitalization was performed in 658 patients, multivessel PCI during the primary PCI session in 1,325, and PCI limited to the infarct-related artery in 4,520. The study endpoints were 2-year all-cause mortality and repeat revascularization.
Staged multivessel PCI had the lowest mortality and repeat revascularization rates. The 2-year mortality rate associated with this strategy was 45% less than with multivessel intervention at the time of primary PCI and 35% lower than for culprit vessel-only PCI, which unsurprisingly had the highest repeat revascularization rate (JACC Cardiovasc Interv. 2017 Jan 9;10(1):11-23).
The first of the three randomized trials that led to a change in the guidelines was the UK PRAMI study (Preventive Angioplasty in Acute Myocardial Infarction). It showed at a mean 23-months followup that STEMI patients with multivessel disease had a 65% reduction in the relative risk of a composite endoint of cardiovascular death, MI, or refractory angina if they received non-IRA PCI at the same time as primary PCI compared with PCI limited to the IRA (N Engl J Med. 2013 Sep 19;369(12):1115-23).
Next came another UK trial: CvLPRIT (Complete vs. Culprit-Lesion Only Primary PCI) demonstrated a 65% reduction in the composite 12-month outcome of all-cause mortality, MI, heart failure, or ischemia-driven PCI with staged PCI during the index hospitalization compared with culprit vessel-only PCI (J Am Coll Cardiol. 2015 Mar 17;65(10):963-72).
Finally, DANAMI-3-PRIMULTI (the Third Danish Study of Optimal Acute Treatment of Patients with STEMI: Primary PCI in Multivessel Disease) showed a dramatic reduction in the risk of ischemia-driven PCI during a median 27 months of followup in patients who underwent staged multivessel PCI guided by the findings of fractional flow reserve measurement compared with primary PCI limited to the IRA (Lancet. 2015 Aug 15;386(9994):665-71). However, fractional flow reserve-guided multivessel PCI didn’t decrease the risk of death or nonfatal recurrent MI, leaving its role unsettled pending the results of ongoing clinical trials.
Dr. Drachman said it’s clear certain STEMI patients should not undergo non-IRA PCI. These include anyone in whom the procedure would be lengthy due to vessel tortuosity or chronic total occlusion, as well as patients with stable saphenous vein graft disease or heavily calcified lesions requiring atherectomy, since multivessel PCI in those settings would pose a high risk for additional left ventricular dysfunction.
“Be thoughtful about patients who have renal dysfunction,” he added.
Dr. Drachman reported having no financial conflicts of interest.
SNOWMASS, COLO. – The tide appears to have turned regarding the merits of percutaneous coronary intervention in non-infarct-related arteries in conjunction with primary PCI for ST-elevation MI in patients with multivessel disease, Douglas E. Drachman, MD, said at the Annual Cardiovascular Conference at Snowmass.
Previously, multivessel PCI in STEMI patients who are hemodynamically stable was believed harmful and was given a Class IIIb recommendation – meaning don’t do it – in the 2013 American College of Cardiology/American Heart Association STEMI guidelines. Just 2 years later, however, new evidence in the form of three randomized trials prompted a focused update of the joint guidelines in which the practice was upgraded to Class IIb status, meaning it could be considered and may be beneficial.
Roughly 50% of STEMI patients have significant lesions in non-infarct-related arteries (non-IRA). The question of how best to treat such patients is an important one because multivessel coronary disease in STEMI is associated with increased risks of both reinfarction and mortality, noted Dr. Drachman, an interventional cardiologist at Massachusetts General Hospital in Boston.
He offered several reasons why the findings of the three influential randomized trials differed from earlier negative retrospective observational studies: “I would argue there’s been significant improvement in our technique in doing PCI. We’re primarily doing transradial interventions now for our patients, so the risk associated with multiple accesses is reduced. Our ability to use more potent antithrombotic strategies is enhanced by our concern about bleeding risk. And the stent platforms that we use in our interventional strategies have improved to the point that we are tackling ever more challenging lesions with greater aplomb and less concern that we may cause harm. I think all these factors have enhanced the ability of the interventionalist to select and treat non-IRAs in a staged fashion and be less parsimonious at the point of care.”
The remaining questions are which non-IRA lesions should be treated, in whom, when relative to primary PCI, and what are the cost implications? These issues are being tackled in at least eight active randomized controlled trials. Depending upon the answers to come, multivessel PCI in STEMI patients could receive a further upgrade in the guidelines.
Since release of the 2015 focused guideline update, several large studies have provided further backing for multivessel PCI in STEMI patients with significant multivessel disease, although these weren’t randomized prospective studies and hence must be considered hypothesis-generating.
One of these major pieces of evidence was a meta-analysis of observational studies led by Eric R. Bates, MD, professor of internal medicine at the University of Michigan in Ann Arbor. He and his coinvestigators analyzed studies comparing culprit vessel-only primary PCI for STEMI patients with multivessel disease versus staged PCI in which primary PCI was done first, followed by PCI of a non-infarct-related vessel later during the same hospitalization or soon after. Staged PCI was the clear winner, with a 2.2-fold greater likelihood of freedom from mortality (J Am Coll Cardiol. 2016 Sep 6;68(10):1066-81).
When the investigators compared studies of staged PCI versus multivessel PCI in the same session as primary PCI, staged PCI was again the clear winner, with a 4-fold greater freedom from mortality.
Among the possible risks of performing PCI of a non-IRA in the same session as primary PCI are increased risks of thrombosis, contrast-induced nephropathy, stent undersizing due to vasospasm, and unintended jeopardy of distant viable myocardium due to microembolization or side branch occlusion, Dr. Drachman said.
“Maybe in certain circumstances it’s best to let the dust settle after the urgent vessel intervention. Wait a couple of days and then make your plan,” the cardiologist advised.
Another informative recent piece of evidence was provided by a Canadian retrospective observational study which compared revascularization strategies in 6,503 consecutive STEMI patients with multivessel disease. Staged multivessel PCI during the index hospitalization was performed in 658 patients, multivessel PCI during the primary PCI session in 1,325, and PCI limited to the infarct-related artery in 4,520. The study endpoints were 2-year all-cause mortality and repeat revascularization.
Staged multivessel PCI had the lowest mortality and repeat revascularization rates. The 2-year mortality rate associated with this strategy was 45% less than with multivessel intervention at the time of primary PCI and 35% lower than for culprit vessel-only PCI, which unsurprisingly had the highest repeat revascularization rate (JACC Cardiovasc Interv. 2017 Jan 9;10(1):11-23).
The first of the three randomized trials that led to a change in the guidelines was the UK PRAMI study (Preventive Angioplasty in Acute Myocardial Infarction). It showed at a mean 23-months followup that STEMI patients with multivessel disease had a 65% reduction in the relative risk of a composite endoint of cardiovascular death, MI, or refractory angina if they received non-IRA PCI at the same time as primary PCI compared with PCI limited to the IRA (N Engl J Med. 2013 Sep 19;369(12):1115-23).
Next came another UK trial: CvLPRIT (Complete vs. Culprit-Lesion Only Primary PCI) demonstrated a 65% reduction in the composite 12-month outcome of all-cause mortality, MI, heart failure, or ischemia-driven PCI with staged PCI during the index hospitalization compared with culprit vessel-only PCI (J Am Coll Cardiol. 2015 Mar 17;65(10):963-72).
Finally, DANAMI-3-PRIMULTI (the Third Danish Study of Optimal Acute Treatment of Patients with STEMI: Primary PCI in Multivessel Disease) showed a dramatic reduction in the risk of ischemia-driven PCI during a median 27 months of followup in patients who underwent staged multivessel PCI guided by the findings of fractional flow reserve measurement compared with primary PCI limited to the IRA (Lancet. 2015 Aug 15;386(9994):665-71). However, fractional flow reserve-guided multivessel PCI didn’t decrease the risk of death or nonfatal recurrent MI, leaving its role unsettled pending the results of ongoing clinical trials.
Dr. Drachman said it’s clear certain STEMI patients should not undergo non-IRA PCI. These include anyone in whom the procedure would be lengthy due to vessel tortuosity or chronic total occlusion, as well as patients with stable saphenous vein graft disease or heavily calcified lesions requiring atherectomy, since multivessel PCI in those settings would pose a high risk for additional left ventricular dysfunction.
“Be thoughtful about patients who have renal dysfunction,” he added.
Dr. Drachman reported having no financial conflicts of interest.
EXPERT ANALYSIS FROM THE CARDIOVASCULAR CONFERENCE AT SNOWMASS
New thinking on septal myectomy vs. alcohol ablation for obstructive cardiomyopathy
SNOWMASS, COLO. – The first-ever national study of the impact of hospital volume on outcomes of septal myectomy versus alcohol septal ablation for treatment of obstructive hypertrophic cardiomyopathy deserves to be practice-changing, Rick A. Nishimura, MD, said at the Annual Cardiovascular Conference at Snowmass.
Prior to release of these eye-opening data, conventional thinking held that referral for percutaneous septal ablation was the preferred option for elderly, sedentary patients with lots of comorbid conditions and a limited remaining lifespan, while surgical septal myectomy was the best fix for young, active, relatively healthy patients because of its impressive durability of benefit.
Similarly, 80% of alcohol ablations took place at centers doing less than 20 cases over 9 years. But the success of the percutaneous procedure was less dependent upon large institutional volumes. Only at the lowest-volume centers, where a total of fewer than 10 of the procedures were done over 9 years, was procedural mortality significantly higher – indeed, three- to fourfold higher – than at mid- or high-volume institutions or centers of excellence, all of which had similar mortality rates. The same was true for rates of postoperative complete heart block requiring a permanent pacemaker: significantly higher only at the lowest-volume institutions, according to the investigators from Weill Cornell Medical College in New York (JAMA Cardiol. 2016 Jun 1;1[3]:324-32).
“I think the bottom line is this: for the patient who is severely symptomatic with obstruction on optimal medical therapy, septal myectomy probably offers the best chance of excellent long-term symptomatic improvement, but the mortality depends on the center and the surgical expertise there, and complications do, too. This is something good to know that we never had data on before, that if you can’t get to a center with an experienced surgeon doing myectomies, it’s reasonable to go to a center doing ablations as long as there is some experience with the procedure there,” said Dr. Nishimura, professor of cardiovascular diseases and hypertension at the Mayo Clinic in Rochester, Minn.
Of the 11,248 patients treated for obstructive hypertrophic cardiomyopathy identified by the Cornell investigators using the Agency for Healthcare Research and Quality National Inpatient Sample database, 57% got myectomy and 43% underwent ablation. During the study years ablation increased in popularity by about 50%, rising from an annual rate of 1.6 to 2.5 procedures per million per year, while myectomy declined from 2.0 to 1.5 cases per million population per year. But that’s not what’s happened at the Mayo Clinic and other hypertrophic cardiomyopathy centers of excellence.
At the Mayo Clinic, for example, the volume of septal myectomies climbed from roughly 50 procedures per year in 2000 to close to 250 in 2015. Meanwhile the rate of alcohol septal ablation procedures remained steady at fewer than 20 per year.
“With shared decision making at Mayo, surgery has gone way up,” said Dr. Nishimura. “In an experienced surgeon’s hands, operative mortality is 0.8%, the gradient improves to 3%, and 94% of patients are postoperative New York Heart Association class I or II. This lasts for decades. We have 20-, 30-, and 40-year follow-up data now showing that over 90% of patients will have an excellent symptomatic benefit and be able to return to a normal lifestyle. The septum doesn’t come back. They’re good for life. So it’s a wonderful operation.”
In contrast, catheter-based septal ablation has a 4-year rate of survival free of death, NYHA class III or IV, or myectomy of 76%.
“One in four treated patients will not benefit,” the cardiologist emphasized.
The percutaneous procedure entails instilling alcohol into the septal perforator artery supplying the area of obstruction in order to cause a localized MI. Over a period of several weeks this causes the septum to shrink, thereby relieving the outflow tract obstruction.
When the procedure fails to bring about improvement, it’s often because the patient had a very long septal perforator artery and instilling the alcohol caused a large MI, making things worse. Or the patient didn’t have a septal perforator artery, or had one with so many branches that the cardiologist couldn’t identify the right one to treat to target the septum.
Dr. Nishimura reported having no financial conflicts.
SNOWMASS, COLO. – The first-ever national study of the impact of hospital volume on outcomes of septal myectomy versus alcohol septal ablation for treatment of obstructive hypertrophic cardiomyopathy deserves to be practice-changing, Rick A. Nishimura, MD, said at the Annual Cardiovascular Conference at Snowmass.
Prior to release of these eye-opening data, conventional thinking held that referral for percutaneous septal ablation was the preferred option for elderly, sedentary patients with lots of comorbid conditions and a limited remaining lifespan, while surgical septal myectomy was the best fix for young, active, relatively healthy patients because of its impressive durability of benefit.
Similarly, 80% of alcohol ablations took place at centers doing less than 20 cases over 9 years. But the success of the percutaneous procedure was less dependent upon large institutional volumes. Only at the lowest-volume centers, where a total of fewer than 10 of the procedures were done over 9 years, was procedural mortality significantly higher – indeed, three- to fourfold higher – than at mid- or high-volume institutions or centers of excellence, all of which had similar mortality rates. The same was true for rates of postoperative complete heart block requiring a permanent pacemaker: significantly higher only at the lowest-volume institutions, according to the investigators from Weill Cornell Medical College in New York (JAMA Cardiol. 2016 Jun 1;1[3]:324-32).
“I think the bottom line is this: for the patient who is severely symptomatic with obstruction on optimal medical therapy, septal myectomy probably offers the best chance of excellent long-term symptomatic improvement, but the mortality depends on the center and the surgical expertise there, and complications do, too. This is something good to know that we never had data on before, that if you can’t get to a center with an experienced surgeon doing myectomies, it’s reasonable to go to a center doing ablations as long as there is some experience with the procedure there,” said Dr. Nishimura, professor of cardiovascular diseases and hypertension at the Mayo Clinic in Rochester, Minn.
Of the 11,248 patients treated for obstructive hypertrophic cardiomyopathy identified by the Cornell investigators using the Agency for Healthcare Research and Quality National Inpatient Sample database, 57% got myectomy and 43% underwent ablation. During the study years ablation increased in popularity by about 50%, rising from an annual rate of 1.6 to 2.5 procedures per million per year, while myectomy declined from 2.0 to 1.5 cases per million population per year. But that’s not what’s happened at the Mayo Clinic and other hypertrophic cardiomyopathy centers of excellence.
At the Mayo Clinic, for example, the volume of septal myectomies climbed from roughly 50 procedures per year in 2000 to close to 250 in 2015. Meanwhile the rate of alcohol septal ablation procedures remained steady at fewer than 20 per year.
“With shared decision making at Mayo, surgery has gone way up,” said Dr. Nishimura. “In an experienced surgeon’s hands, operative mortality is 0.8%, the gradient improves to 3%, and 94% of patients are postoperative New York Heart Association class I or II. This lasts for decades. We have 20-, 30-, and 40-year follow-up data now showing that over 90% of patients will have an excellent symptomatic benefit and be able to return to a normal lifestyle. The septum doesn’t come back. They’re good for life. So it’s a wonderful operation.”
In contrast, catheter-based septal ablation has a 4-year rate of survival free of death, NYHA class III or IV, or myectomy of 76%.
“One in four treated patients will not benefit,” the cardiologist emphasized.
The percutaneous procedure entails instilling alcohol into the septal perforator artery supplying the area of obstruction in order to cause a localized MI. Over a period of several weeks this causes the septum to shrink, thereby relieving the outflow tract obstruction.
When the procedure fails to bring about improvement, it’s often because the patient had a very long septal perforator artery and instilling the alcohol caused a large MI, making things worse. Or the patient didn’t have a septal perforator artery, or had one with so many branches that the cardiologist couldn’t identify the right one to treat to target the septum.
Dr. Nishimura reported having no financial conflicts.
SNOWMASS, COLO. – The first-ever national study of the impact of hospital volume on outcomes of septal myectomy versus alcohol septal ablation for treatment of obstructive hypertrophic cardiomyopathy deserves to be practice-changing, Rick A. Nishimura, MD, said at the Annual Cardiovascular Conference at Snowmass.
Prior to release of these eye-opening data, conventional thinking held that referral for percutaneous septal ablation was the preferred option for elderly, sedentary patients with lots of comorbid conditions and a limited remaining lifespan, while surgical septal myectomy was the best fix for young, active, relatively healthy patients because of its impressive durability of benefit.
Similarly, 80% of alcohol ablations took place at centers doing less than 20 cases over 9 years. But the success of the percutaneous procedure was less dependent upon large institutional volumes. Only at the lowest-volume centers, where a total of fewer than 10 of the procedures were done over 9 years, was procedural mortality significantly higher – indeed, three- to fourfold higher – than at mid- or high-volume institutions or centers of excellence, all of which had similar mortality rates. The same was true for rates of postoperative complete heart block requiring a permanent pacemaker: significantly higher only at the lowest-volume institutions, according to the investigators from Weill Cornell Medical College in New York (JAMA Cardiol. 2016 Jun 1;1[3]:324-32).
“I think the bottom line is this: for the patient who is severely symptomatic with obstruction on optimal medical therapy, septal myectomy probably offers the best chance of excellent long-term symptomatic improvement, but the mortality depends on the center and the surgical expertise there, and complications do, too. This is something good to know that we never had data on before, that if you can’t get to a center with an experienced surgeon doing myectomies, it’s reasonable to go to a center doing ablations as long as there is some experience with the procedure there,” said Dr. Nishimura, professor of cardiovascular diseases and hypertension at the Mayo Clinic in Rochester, Minn.
Of the 11,248 patients treated for obstructive hypertrophic cardiomyopathy identified by the Cornell investigators using the Agency for Healthcare Research and Quality National Inpatient Sample database, 57% got myectomy and 43% underwent ablation. During the study years ablation increased in popularity by about 50%, rising from an annual rate of 1.6 to 2.5 procedures per million per year, while myectomy declined from 2.0 to 1.5 cases per million population per year. But that’s not what’s happened at the Mayo Clinic and other hypertrophic cardiomyopathy centers of excellence.
At the Mayo Clinic, for example, the volume of septal myectomies climbed from roughly 50 procedures per year in 2000 to close to 250 in 2015. Meanwhile the rate of alcohol septal ablation procedures remained steady at fewer than 20 per year.
“With shared decision making at Mayo, surgery has gone way up,” said Dr. Nishimura. “In an experienced surgeon’s hands, operative mortality is 0.8%, the gradient improves to 3%, and 94% of patients are postoperative New York Heart Association class I or II. This lasts for decades. We have 20-, 30-, and 40-year follow-up data now showing that over 90% of patients will have an excellent symptomatic benefit and be able to return to a normal lifestyle. The septum doesn’t come back. They’re good for life. So it’s a wonderful operation.”
In contrast, catheter-based septal ablation has a 4-year rate of survival free of death, NYHA class III or IV, or myectomy of 76%.
“One in four treated patients will not benefit,” the cardiologist emphasized.
The percutaneous procedure entails instilling alcohol into the septal perforator artery supplying the area of obstruction in order to cause a localized MI. Over a period of several weeks this causes the septum to shrink, thereby relieving the outflow tract obstruction.
When the procedure fails to bring about improvement, it’s often because the patient had a very long septal perforator artery and instilling the alcohol caused a large MI, making things worse. Or the patient didn’t have a septal perforator artery, or had one with so many branches that the cardiologist couldn’t identify the right one to treat to target the septum.
Dr. Nishimura reported having no financial conflicts.
Subclinical AF found in 1/3 of asymptomatic elderly
NEW ORLEANS – About a third of elderly people at high cardiovascular risk but otherwise healthy and asymptomatic had subclinical atrial fibrillation in a multicenter study of 273 people.
This finding that subclinical atrial fibrillation (AF) is “extremely common” in elderly people with cardiovascular risk factors “weakens the case that detecting subclinical AF in patients following a stroke implies causality” of the stroke “because subclinical AF is so prevalent,” Jeff S. Healey, MD, said at the American Heart Association Scientific Sessions.
“I think that subclinical AF is a distinct subgroup of AF, with a risk for stroke that is quite low, about 1.5%-2% per year,” said Dr. Healey, a cardiologist at McMaster University in Hamilton, Canada. “Given that this was an elderly population [study participants averaged 74 years old] with bleeding risk, it’s reasonable to question” whether many people with subclinical AF need anticoagulation. The question of whether “45 seconds of AF seen 6 months after a stroke is worthy of treatment with an anticoagulant should give people pause,” he said.
The Prevalence of Sub-Clinical Atrial Fibrillation Using an Implantable Cardiac Monitor (ASSERT-II) study initially enrolled 273 people at 26 sites in Canada and The Netherlands. Researchers actually placed a loop recorder in 256, and complete follow-up of at least 9 months occurred for 252. Enrolled patients had to be at 65 years old, and have at least one of these risk factors for AF or stroke: a CHA2DS2-VASc score of 2 or greater; documented obstructive sleep apnea; or a body mass index greater than 30 kg/m2. In addition, enrollees also had to have one of these risk factors for AF: a left atrial volume of at least 58 ml; a left atrial diameter of at least 4.4 cm; or a serum NT-proBNP level of at least 290 pg/mL.
Dr. Healey and his associates prespecified subclinical AF as at least 5 minutes of AF seen in the loop recording during follow-up, which occurred in 34% of the participants during an average 16 months of follow-up, he reported. At least 30 minutes of AF occurred in 22% during follow-up, at least 6 hours in 7%, and at least 24 hours in 3%.
In a prespecified set of subgroup analyses, people with a large left atrium formed the only subgroup with a statistically significant association with outcome. People with a left atrial size at or above the study median of 73.5 ml had an 85% increased rate of subclinical AF compared with those with smaller left atria in the multivariate analysis. But increased left atrial size alone did not fully explain subclinical atrial fibrillation. Even among participants in the lowest quartile for left atrial diameter, less than 4.3 cm, the prevalence of subclinical AF was 27%, Dr. Healey noted.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
The results reported by Dr. Healey provide robust data that bridges a major gap we have had in our understanding of atrial fibrillation. The new finding of a high prevalence of subclinical atrial fibrillation in elderly people with cardiovascular risk factors, regardless of whether they had a prior stroke, substantially weakens the case that subclinical atrial fibrillation detected following a stroke has a causal relationship to the stroke. This implication is quite important.
Many questions remain about the meaning of subclinical atrial fibrillation. What relationship does it have with stroke, and what thresholds exist for atrial fibrillation to raise stroke risk? Also, what are the risks and benefits of anticoagulation in people with subclinical AF and is intermittent anticoagulation helpful?
N.A. Mark Estes III, MD , is professor of medicine and director of the New England Cardiac Arrhythmia Center at Tufts Medical Center in Boston. He has been a consultant to Boston Scientific, Medtronic and St. Jude. He made these comments as designated discussant for ASSERT-II.
The results reported by Dr. Healey provide robust data that bridges a major gap we have had in our understanding of atrial fibrillation. The new finding of a high prevalence of subclinical atrial fibrillation in elderly people with cardiovascular risk factors, regardless of whether they had a prior stroke, substantially weakens the case that subclinical atrial fibrillation detected following a stroke has a causal relationship to the stroke. This implication is quite important.
Many questions remain about the meaning of subclinical atrial fibrillation. What relationship does it have with stroke, and what thresholds exist for atrial fibrillation to raise stroke risk? Also, what are the risks and benefits of anticoagulation in people with subclinical AF and is intermittent anticoagulation helpful?
N.A. Mark Estes III, MD , is professor of medicine and director of the New England Cardiac Arrhythmia Center at Tufts Medical Center in Boston. He has been a consultant to Boston Scientific, Medtronic and St. Jude. He made these comments as designated discussant for ASSERT-II.
The results reported by Dr. Healey provide robust data that bridges a major gap we have had in our understanding of atrial fibrillation. The new finding of a high prevalence of subclinical atrial fibrillation in elderly people with cardiovascular risk factors, regardless of whether they had a prior stroke, substantially weakens the case that subclinical atrial fibrillation detected following a stroke has a causal relationship to the stroke. This implication is quite important.
Many questions remain about the meaning of subclinical atrial fibrillation. What relationship does it have with stroke, and what thresholds exist for atrial fibrillation to raise stroke risk? Also, what are the risks and benefits of anticoagulation in people with subclinical AF and is intermittent anticoagulation helpful?
N.A. Mark Estes III, MD , is professor of medicine and director of the New England Cardiac Arrhythmia Center at Tufts Medical Center in Boston. He has been a consultant to Boston Scientific, Medtronic and St. Jude. He made these comments as designated discussant for ASSERT-II.
NEW ORLEANS – About a third of elderly people at high cardiovascular risk but otherwise healthy and asymptomatic had subclinical atrial fibrillation in a multicenter study of 273 people.
This finding that subclinical atrial fibrillation (AF) is “extremely common” in elderly people with cardiovascular risk factors “weakens the case that detecting subclinical AF in patients following a stroke implies causality” of the stroke “because subclinical AF is so prevalent,” Jeff S. Healey, MD, said at the American Heart Association Scientific Sessions.
“I think that subclinical AF is a distinct subgroup of AF, with a risk for stroke that is quite low, about 1.5%-2% per year,” said Dr. Healey, a cardiologist at McMaster University in Hamilton, Canada. “Given that this was an elderly population [study participants averaged 74 years old] with bleeding risk, it’s reasonable to question” whether many people with subclinical AF need anticoagulation. The question of whether “45 seconds of AF seen 6 months after a stroke is worthy of treatment with an anticoagulant should give people pause,” he said.
The Prevalence of Sub-Clinical Atrial Fibrillation Using an Implantable Cardiac Monitor (ASSERT-II) study initially enrolled 273 people at 26 sites in Canada and The Netherlands. Researchers actually placed a loop recorder in 256, and complete follow-up of at least 9 months occurred for 252. Enrolled patients had to be at 65 years old, and have at least one of these risk factors for AF or stroke: a CHA2DS2-VASc score of 2 or greater; documented obstructive sleep apnea; or a body mass index greater than 30 kg/m2. In addition, enrollees also had to have one of these risk factors for AF: a left atrial volume of at least 58 ml; a left atrial diameter of at least 4.4 cm; or a serum NT-proBNP level of at least 290 pg/mL.
Dr. Healey and his associates prespecified subclinical AF as at least 5 minutes of AF seen in the loop recording during follow-up, which occurred in 34% of the participants during an average 16 months of follow-up, he reported. At least 30 minutes of AF occurred in 22% during follow-up, at least 6 hours in 7%, and at least 24 hours in 3%.
In a prespecified set of subgroup analyses, people with a large left atrium formed the only subgroup with a statistically significant association with outcome. People with a left atrial size at or above the study median of 73.5 ml had an 85% increased rate of subclinical AF compared with those with smaller left atria in the multivariate analysis. But increased left atrial size alone did not fully explain subclinical atrial fibrillation. Even among participants in the lowest quartile for left atrial diameter, less than 4.3 cm, the prevalence of subclinical AF was 27%, Dr. Healey noted.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
NEW ORLEANS – About a third of elderly people at high cardiovascular risk but otherwise healthy and asymptomatic had subclinical atrial fibrillation in a multicenter study of 273 people.
This finding that subclinical atrial fibrillation (AF) is “extremely common” in elderly people with cardiovascular risk factors “weakens the case that detecting subclinical AF in patients following a stroke implies causality” of the stroke “because subclinical AF is so prevalent,” Jeff S. Healey, MD, said at the American Heart Association Scientific Sessions.
“I think that subclinical AF is a distinct subgroup of AF, with a risk for stroke that is quite low, about 1.5%-2% per year,” said Dr. Healey, a cardiologist at McMaster University in Hamilton, Canada. “Given that this was an elderly population [study participants averaged 74 years old] with bleeding risk, it’s reasonable to question” whether many people with subclinical AF need anticoagulation. The question of whether “45 seconds of AF seen 6 months after a stroke is worthy of treatment with an anticoagulant should give people pause,” he said.
The Prevalence of Sub-Clinical Atrial Fibrillation Using an Implantable Cardiac Monitor (ASSERT-II) study initially enrolled 273 people at 26 sites in Canada and The Netherlands. Researchers actually placed a loop recorder in 256, and complete follow-up of at least 9 months occurred for 252. Enrolled patients had to be at 65 years old, and have at least one of these risk factors for AF or stroke: a CHA2DS2-VASc score of 2 or greater; documented obstructive sleep apnea; or a body mass index greater than 30 kg/m2. In addition, enrollees also had to have one of these risk factors for AF: a left atrial volume of at least 58 ml; a left atrial diameter of at least 4.4 cm; or a serum NT-proBNP level of at least 290 pg/mL.
Dr. Healey and his associates prespecified subclinical AF as at least 5 minutes of AF seen in the loop recording during follow-up, which occurred in 34% of the participants during an average 16 months of follow-up, he reported. At least 30 minutes of AF occurred in 22% during follow-up, at least 6 hours in 7%, and at least 24 hours in 3%.
In a prespecified set of subgroup analyses, people with a large left atrium formed the only subgroup with a statistically significant association with outcome. People with a left atrial size at or above the study median of 73.5 ml had an 85% increased rate of subclinical AF compared with those with smaller left atria in the multivariate analysis. But increased left atrial size alone did not fully explain subclinical atrial fibrillation. Even among participants in the lowest quartile for left atrial diameter, less than 4.3 cm, the prevalence of subclinical AF was 27%, Dr. Healey noted.
mzoler@frontlinemedcom.com
On Twitter @mitchelzoler
AT THE AHA SCIENTIFIC SESSIONS
Key clinical point:
Major finding: One-third of asymptomatic elderly people with cardiovascular risk factors had subclinical atrial fibrillation.
Data source: A multicenter study with 252 people followed for an average of 16 months.
Disclosures: Dr. Healey has been a consultant to or received honoraria from Bayer, Medtronic, Pfizer and Servier. He has received research support from Boehringer Ingelheim, Boston Scientific, Bristol-Myers Squibb, Medtronic and St. Jude.
LAA closure during cardiac surgery cuts late mortality
NEW ORLEANS – Surgical left atrial appendage closure at the time of open heart surgery in patients with atrial fibrillation doesn’t decrease patients’ early or late risk of stroke, but it does substantially reduce their risk of late mortality, Masahiko Ando, MD, reported at the American Heart Association scientific sessions.
Solid evidence demonstrates that percutaneous left atrial appendage (LAA) closure using the Watchman or other devices in patients with atrial fibrillation offers a potential alternative to lifelong oral anticoagulation.
In contrast, even though surgical LAA closure at the time of cardiac surgery is commonly done, the data as to its long-term impact are scanty. This was the impetus for Dr. Ando and his coinvestigators at Massachusetts General Hospital in Boston to perform a comprehensive systematic review of the medical literature. They also conducted a meta-analysis that involved 7,466 patients who underwent open-heart surgery with or without surgical LAA closure in 12 studies, 3 of which were randomized controlled trials, 2 propensity-matched comparisons, and the rest cohort studies.
At 30-day follow-up, LAA closure was not associated with any significant effect on the risks of stroke, death, reexploration for bleeding, or postoperative atrial fibrillation.
At the latest follow-up in the studies, however, surgical LAA closure was associated with a highly significant 36% reduction in mortality risk compared with the no–LAA-closure control group. This remained the case even after statistical adjustment for demographics, type of cardiac surgery, and the form of preoperative atrial fibrillation.
“Given that we generally add LAA closure to those who have a higher risk of embolization, which could have negatively affected the efficacy of LAA closure, this preventive effect of LAA closure on late mortality cannot be ignored,” said Dr. Ando.
The most likely explanation for the improved survival in surgical LAA closure recipients, he continued, is that the procedure enabled them to avoid aggressive lifelong oral anticoagulation, with its attendant risks.
Dr. Ando reported having no financial conflicts regarding his study.
NEW ORLEANS – Surgical left atrial appendage closure at the time of open heart surgery in patients with atrial fibrillation doesn’t decrease patients’ early or late risk of stroke, but it does substantially reduce their risk of late mortality, Masahiko Ando, MD, reported at the American Heart Association scientific sessions.
Solid evidence demonstrates that percutaneous left atrial appendage (LAA) closure using the Watchman or other devices in patients with atrial fibrillation offers a potential alternative to lifelong oral anticoagulation.
In contrast, even though surgical LAA closure at the time of cardiac surgery is commonly done, the data as to its long-term impact are scanty. This was the impetus for Dr. Ando and his coinvestigators at Massachusetts General Hospital in Boston to perform a comprehensive systematic review of the medical literature. They also conducted a meta-analysis that involved 7,466 patients who underwent open-heart surgery with or without surgical LAA closure in 12 studies, 3 of which were randomized controlled trials, 2 propensity-matched comparisons, and the rest cohort studies.
At 30-day follow-up, LAA closure was not associated with any significant effect on the risks of stroke, death, reexploration for bleeding, or postoperative atrial fibrillation.
At the latest follow-up in the studies, however, surgical LAA closure was associated with a highly significant 36% reduction in mortality risk compared with the no–LAA-closure control group. This remained the case even after statistical adjustment for demographics, type of cardiac surgery, and the form of preoperative atrial fibrillation.
“Given that we generally add LAA closure to those who have a higher risk of embolization, which could have negatively affected the efficacy of LAA closure, this preventive effect of LAA closure on late mortality cannot be ignored,” said Dr. Ando.
The most likely explanation for the improved survival in surgical LAA closure recipients, he continued, is that the procedure enabled them to avoid aggressive lifelong oral anticoagulation, with its attendant risks.
Dr. Ando reported having no financial conflicts regarding his study.
NEW ORLEANS – Surgical left atrial appendage closure at the time of open heart surgery in patients with atrial fibrillation doesn’t decrease patients’ early or late risk of stroke, but it does substantially reduce their risk of late mortality, Masahiko Ando, MD, reported at the American Heart Association scientific sessions.
Solid evidence demonstrates that percutaneous left atrial appendage (LAA) closure using the Watchman or other devices in patients with atrial fibrillation offers a potential alternative to lifelong oral anticoagulation.
In contrast, even though surgical LAA closure at the time of cardiac surgery is commonly done, the data as to its long-term impact are scanty. This was the impetus for Dr. Ando and his coinvestigators at Massachusetts General Hospital in Boston to perform a comprehensive systematic review of the medical literature. They also conducted a meta-analysis that involved 7,466 patients who underwent open-heart surgery with or without surgical LAA closure in 12 studies, 3 of which were randomized controlled trials, 2 propensity-matched comparisons, and the rest cohort studies.
At 30-day follow-up, LAA closure was not associated with any significant effect on the risks of stroke, death, reexploration for bleeding, or postoperative atrial fibrillation.
At the latest follow-up in the studies, however, surgical LAA closure was associated with a highly significant 36% reduction in mortality risk compared with the no–LAA-closure control group. This remained the case even after statistical adjustment for demographics, type of cardiac surgery, and the form of preoperative atrial fibrillation.
“Given that we generally add LAA closure to those who have a higher risk of embolization, which could have negatively affected the efficacy of LAA closure, this preventive effect of LAA closure on late mortality cannot be ignored,” said Dr. Ando.
The most likely explanation for the improved survival in surgical LAA closure recipients, he continued, is that the procedure enabled them to avoid aggressive lifelong oral anticoagulation, with its attendant risks.
Dr. Ando reported having no financial conflicts regarding his study.
AT THE AHA SCIENTIFIC SESSIONS
Key clinical point:
Major finding: Late mortality risk was reduced by 36% in patients with atrial fibrillation who underwent surgical LAA closure during open heart surgery, compared with those who did not.
Data source: This meta-analysis included 12 published studies and 7,466 patients who either did or did not undergo surgical LAA closure during open heart surgery.
Disclosures: The study presenter reported having no financial conflicts.
Regenerative medicine is likely game changer for cardiovascular disease
NEW ORLEANS – Regenerative medicine has much to offer the cardiovascular field, although there is still a way to go before it is ready for routine clinical application, according to Andre Terzic, MD, PhD, director of the Mayo Clinic Center for Regenerative Medicine and a professor in Cardiovascular Diseases Research at the Mayo Clinic, in Rochester, Minn.
Trials testing a variety of stem cell approaches in patients with conditions such as acute myocardial infarction, peripheral arterial disease, and dilated cardiomyopathy are providing important lessons about this novel strategy and showing its potential, he said in a state of the science talk at the American Heart Association scientific sessions.
Impact on therapeutic approaches and goals
“This is a true paradigm shift in how we are approaching patients from a more traditional fighting of disease, whether it’s in the vascular or cardiac arena, to ultimately really where regenerative medicine is driving: rebuilding vascular and heart health,” Dr. Terzic maintained.
Leaders in the field have put forth an associated value proposition, estimating that a decade from now, regenerative medicine will account for about 10% of all health care delivered globally, according to Dr. Terzic. And research presented at the meeting is a major step in that direction.
The potential applications in cardiovascular medicine are numerous, he proposed. Regenerative medicine might be used in prophylactic strategies, for protection against chronic disease, and in bridging strategies, to delay transplantation in patients with end organ damage. It might also be used in combination approaches, to augment the efficacy of primary therapy, and even to generate new organs for patients who have run out of options.
The specific therapeutic goals depend on the stage of disease. For example, the goal is to boost cardioprotection and limit inflammation in acute myocardial infarction; to augment myocardial regenerative reserve and improve survival in subacute disease; and to enhance the pro-reparative environment and restore structure and function in the setting of chronic cardiomyopathy.
Bringing regenerative medicine to the clinic
Ultimately, the health care field is striving to bring the science of regenerative medicine into the clinic, and turn the research pipeline into a clinical service line, Dr. Terzic said.
As might be expected, the whole process begins with identification of an unmet need in patients, which in turn generates a specific practice advancement goal. In the cardiovascular arena, the process has largely been driven by smaller collaborative groups and champions in the field, but is increasingly garnering new support from the business world and national networks.
“The importance at the moment is the experiences that are being built allow for a true iterative process in harnessing this new knowledge and essentially developing even more refined and more effective solutions as we look into the future,” Dr. Terzic commented.
“The cardiovascular field is clearly not alone, but is working in tandem with many other fields that are evolving rapidly in this area,” he added. “And I think the collective experience will be one of the main drivers as we build this shared vision for a practice not only for regenerative solutions, but for practice-integrated regenerative medicine, ultimately, as one of the models of care in the decade to come.”
A blueprint for moving forward
Dr. Terzic and his colleagues at the Mayo Clinic have developed a framework for advancing the field that is being used at their institution but could also be used elsewhere (Eur Heart J. 2016;37:1089-90).
“What we have historically been doing for the last decade or so is really building this discovery knowledge, and then moving it into translation and ultimately application,” he explained. “We call this a blueprint, a blueprint that has helped us all collectively get where we are today.”
For each of these three domains, investigators strive to build out the concept, starting with the specific regenerative technology or product, proceeding to its manufacture or production, and eventually devising ways to deliver it to patients through a clinical-grade supply chain available at the point of care.
“There is a new evolving concept of truly building a regenerative medicine care model,” summarized Dr. Terzic, who disclosed no relevant conflicts of interest. “Today, we are not fully there. We are really speaking about technological and translational readiness. But ultimately, the goal is to ensure clinical readiness.”
NEW ORLEANS – Regenerative medicine has much to offer the cardiovascular field, although there is still a way to go before it is ready for routine clinical application, according to Andre Terzic, MD, PhD, director of the Mayo Clinic Center for Regenerative Medicine and a professor in Cardiovascular Diseases Research at the Mayo Clinic, in Rochester, Minn.
Trials testing a variety of stem cell approaches in patients with conditions such as acute myocardial infarction, peripheral arterial disease, and dilated cardiomyopathy are providing important lessons about this novel strategy and showing its potential, he said in a state of the science talk at the American Heart Association scientific sessions.
Impact on therapeutic approaches and goals
“This is a true paradigm shift in how we are approaching patients from a more traditional fighting of disease, whether it’s in the vascular or cardiac arena, to ultimately really where regenerative medicine is driving: rebuilding vascular and heart health,” Dr. Terzic maintained.
Leaders in the field have put forth an associated value proposition, estimating that a decade from now, regenerative medicine will account for about 10% of all health care delivered globally, according to Dr. Terzic. And research presented at the meeting is a major step in that direction.
The potential applications in cardiovascular medicine are numerous, he proposed. Regenerative medicine might be used in prophylactic strategies, for protection against chronic disease, and in bridging strategies, to delay transplantation in patients with end organ damage. It might also be used in combination approaches, to augment the efficacy of primary therapy, and even to generate new organs for patients who have run out of options.
The specific therapeutic goals depend on the stage of disease. For example, the goal is to boost cardioprotection and limit inflammation in acute myocardial infarction; to augment myocardial regenerative reserve and improve survival in subacute disease; and to enhance the pro-reparative environment and restore structure and function in the setting of chronic cardiomyopathy.
Bringing regenerative medicine to the clinic
Ultimately, the health care field is striving to bring the science of regenerative medicine into the clinic, and turn the research pipeline into a clinical service line, Dr. Terzic said.
As might be expected, the whole process begins with identification of an unmet need in patients, which in turn generates a specific practice advancement goal. In the cardiovascular arena, the process has largely been driven by smaller collaborative groups and champions in the field, but is increasingly garnering new support from the business world and national networks.
“The importance at the moment is the experiences that are being built allow for a true iterative process in harnessing this new knowledge and essentially developing even more refined and more effective solutions as we look into the future,” Dr. Terzic commented.
“The cardiovascular field is clearly not alone, but is working in tandem with many other fields that are evolving rapidly in this area,” he added. “And I think the collective experience will be one of the main drivers as we build this shared vision for a practice not only for regenerative solutions, but for practice-integrated regenerative medicine, ultimately, as one of the models of care in the decade to come.”
A blueprint for moving forward
Dr. Terzic and his colleagues at the Mayo Clinic have developed a framework for advancing the field that is being used at their institution but could also be used elsewhere (Eur Heart J. 2016;37:1089-90).
“What we have historically been doing for the last decade or so is really building this discovery knowledge, and then moving it into translation and ultimately application,” he explained. “We call this a blueprint, a blueprint that has helped us all collectively get where we are today.”
For each of these three domains, investigators strive to build out the concept, starting with the specific regenerative technology or product, proceeding to its manufacture or production, and eventually devising ways to deliver it to patients through a clinical-grade supply chain available at the point of care.
“There is a new evolving concept of truly building a regenerative medicine care model,” summarized Dr. Terzic, who disclosed no relevant conflicts of interest. “Today, we are not fully there. We are really speaking about technological and translational readiness. But ultimately, the goal is to ensure clinical readiness.”
NEW ORLEANS – Regenerative medicine has much to offer the cardiovascular field, although there is still a way to go before it is ready for routine clinical application, according to Andre Terzic, MD, PhD, director of the Mayo Clinic Center for Regenerative Medicine and a professor in Cardiovascular Diseases Research at the Mayo Clinic, in Rochester, Minn.
Trials testing a variety of stem cell approaches in patients with conditions such as acute myocardial infarction, peripheral arterial disease, and dilated cardiomyopathy are providing important lessons about this novel strategy and showing its potential, he said in a state of the science talk at the American Heart Association scientific sessions.
Impact on therapeutic approaches and goals
“This is a true paradigm shift in how we are approaching patients from a more traditional fighting of disease, whether it’s in the vascular or cardiac arena, to ultimately really where regenerative medicine is driving: rebuilding vascular and heart health,” Dr. Terzic maintained.
Leaders in the field have put forth an associated value proposition, estimating that a decade from now, regenerative medicine will account for about 10% of all health care delivered globally, according to Dr. Terzic. And research presented at the meeting is a major step in that direction.
The potential applications in cardiovascular medicine are numerous, he proposed. Regenerative medicine might be used in prophylactic strategies, for protection against chronic disease, and in bridging strategies, to delay transplantation in patients with end organ damage. It might also be used in combination approaches, to augment the efficacy of primary therapy, and even to generate new organs for patients who have run out of options.
The specific therapeutic goals depend on the stage of disease. For example, the goal is to boost cardioprotection and limit inflammation in acute myocardial infarction; to augment myocardial regenerative reserve and improve survival in subacute disease; and to enhance the pro-reparative environment and restore structure and function in the setting of chronic cardiomyopathy.
Bringing regenerative medicine to the clinic
Ultimately, the health care field is striving to bring the science of regenerative medicine into the clinic, and turn the research pipeline into a clinical service line, Dr. Terzic said.
As might be expected, the whole process begins with identification of an unmet need in patients, which in turn generates a specific practice advancement goal. In the cardiovascular arena, the process has largely been driven by smaller collaborative groups and champions in the field, but is increasingly garnering new support from the business world and national networks.
“The importance at the moment is the experiences that are being built allow for a true iterative process in harnessing this new knowledge and essentially developing even more refined and more effective solutions as we look into the future,” Dr. Terzic commented.
“The cardiovascular field is clearly not alone, but is working in tandem with many other fields that are evolving rapidly in this area,” he added. “And I think the collective experience will be one of the main drivers as we build this shared vision for a practice not only for regenerative solutions, but for practice-integrated regenerative medicine, ultimately, as one of the models of care in the decade to come.”
A blueprint for moving forward
Dr. Terzic and his colleagues at the Mayo Clinic have developed a framework for advancing the field that is being used at their institution but could also be used elsewhere (Eur Heart J. 2016;37:1089-90).
“What we have historically been doing for the last decade or so is really building this discovery knowledge, and then moving it into translation and ultimately application,” he explained. “We call this a blueprint, a blueprint that has helped us all collectively get where we are today.”
For each of these three domains, investigators strive to build out the concept, starting with the specific regenerative technology or product, proceeding to its manufacture or production, and eventually devising ways to deliver it to patients through a clinical-grade supply chain available at the point of care.
“There is a new evolving concept of truly building a regenerative medicine care model,” summarized Dr. Terzic, who disclosed no relevant conflicts of interest. “Today, we are not fully there. We are really speaking about technological and translational readiness. But ultimately, the goal is to ensure clinical readiness.”
Key clinical point:
Major finding: Trials testing a variety of stem cell approaches in patients with conditions such as acute MI, PAD, and dilated cardiomyopathy are providing important lessons.
Data source: Expert analysis of current trials by Dr. Terzic.
Disclosures: Dr. Terzic disclosed that he had no relevant conflicts of interest.
Diabetes, ischemic heart disease, pain lead health spending
Diabetes, ischemic heart disease, and back and neck pain are the top three conditions accounting for the highest spending on personal health care in the United States, according to a report published online Dec. 27 in JAMA.
In addition, spending on pharmaceuticals – particularly diabetes therapies, antihypertensive drugs, and medications for hyperlipidemia – drove much of the massive increase in health care spending during the past 2 decades, said Joseph L. Dieleman, PhD, of the Institute for Health Metrics and Evaluation, University of Washington, Seattle, and his associates.
Recent increases in health care spending are well documented, but less is known about what is spent for individual conditions, in different health care settings, and in various patient age groups. To assess health care spending across these categories, the investigators collected and analyzed data for 1996 through 2013 from nationally representative surveys of households, nationally representative surveys of medical facilities, insurance claims, government budgets, and other official records.
They grouped the data into six type-of-care categories: inpatient care, ambulatory care, emergency department care, nursing facility care, dental care, and prescribed pharmaceuticals. “Spending on the six types of personal health care was then disaggregated across 155 mutually exclusive and collectively exhaustive conditions and 38 age and sex groups,” with each sex being divided into 5-year age groups, the researchers noted.
Based on these data, the investigators came to the following conclusions:
• Twenty conditions accounted for approximately 58% of personal health care spending, which totaled an estimated $1.2 trillion in 2013.
• More resources were spent on diabetes than any other condition in 2013, at an estimated $101.4 billion. Prescribed medications accounted for nearly 60% of diabetes costs.
• The second-highest amount of health care spending was for ischemic heart disease, which accounted for $88.1 billion in 2013. Most such spending occurred in inpatient settings.
• Low-back and neck pain, comprising the third-highest level of spending, cost an estimated $87.6 billion. Approximately 60% of this spending occurred in ambulatory settings.
• Among all 155 conditions, spending for diabetes and low-back and neck pain increased the most during the 18-year study period.
• Among all six types of care, spending on pharmaceuticals and emergency care increased the most during the study period.
It is important to note that for the purposes of this study, cancer was disaggregated into 29 separate conditions, and none of them placed in the top 20 for health care spending, Dr. Dieleman and his associates noted (JAMA. 2016;316[24]:2627-46. doi: 10.1001/jama.2016.16885).
When spending was categorized by patient age groups, working-age adults accounted for the greatest amount spent in 2013, estimated at $1,070.1 billion. But that was followed closely by patients aged 65 and older, who accounted for an estimated $796.5 billion, much of which was spent on care in nursing facilities. The smallest amount of health care spending was in children over age 1 and adolescents, who accounted for an estimated $233.5 billion.
Among the other study findings:
• Spending on pharmaceutical treatment of two conditions, hypertension and hyperlipidemia, increased at more than double the rate of total health care spending. It totaled an estimated $135.7 billion in 2013.
• Other top-20 conditions included falls, depression, skin disorders such as acne and eczema, sense disorders such as vision correction and hearing loss, dental care, urinary disorders, and lower respiratory tract infection.
This work was supported by the National Institute on Aging and the Vitality Institute. Dr. Dieleman and his associates reported having no relevant financial disclosures.
Dieleman et al. have “followed” the health care money, and the trail could ultimately lead to the United States changing how it spends a staggering, almost unimaginable amount – roughly $3.2 trillion in 2015 – on health care.
At the very least, their data indicate that the United States should pay more attention to managing physical pain, controlling the costs of pharmaceuticals, and promoting lifestyle interventions that prevent or ameliorate obesity and other factors contributing to diabetes and heart disease.
Ezekiel J. Emanuel, MD, is provost of the department of medical ethics and health policy at the Perelman School of Medicine and in the department of health care management at The Wharton School, University of Pennsylvania, Philadelphia. He reported receiving speaking fees from numerous industry sources. Dr. Emanuel made these remarks in an editorial comment accompanying Dr. Dieleman’s report (JAMA 2016;316:2604-6. doi: 10.1001/jama.2016.16739).
Dieleman et al. have “followed” the health care money, and the trail could ultimately lead to the United States changing how it spends a staggering, almost unimaginable amount – roughly $3.2 trillion in 2015 – on health care.
At the very least, their data indicate that the United States should pay more attention to managing physical pain, controlling the costs of pharmaceuticals, and promoting lifestyle interventions that prevent or ameliorate obesity and other factors contributing to diabetes and heart disease.
Ezekiel J. Emanuel, MD, is provost of the department of medical ethics and health policy at the Perelman School of Medicine and in the department of health care management at The Wharton School, University of Pennsylvania, Philadelphia. He reported receiving speaking fees from numerous industry sources. Dr. Emanuel made these remarks in an editorial comment accompanying Dr. Dieleman’s report (JAMA 2016;316:2604-6. doi: 10.1001/jama.2016.16739).
Dieleman et al. have “followed” the health care money, and the trail could ultimately lead to the United States changing how it spends a staggering, almost unimaginable amount – roughly $3.2 trillion in 2015 – on health care.
At the very least, their data indicate that the United States should pay more attention to managing physical pain, controlling the costs of pharmaceuticals, and promoting lifestyle interventions that prevent or ameliorate obesity and other factors contributing to diabetes and heart disease.
Ezekiel J. Emanuel, MD, is provost of the department of medical ethics and health policy at the Perelman School of Medicine and in the department of health care management at The Wharton School, University of Pennsylvania, Philadelphia. He reported receiving speaking fees from numerous industry sources. Dr. Emanuel made these remarks in an editorial comment accompanying Dr. Dieleman’s report (JAMA 2016;316:2604-6. doi: 10.1001/jama.2016.16739).
Diabetes, ischemic heart disease, and back and neck pain are the top three conditions accounting for the highest spending on personal health care in the United States, according to a report published online Dec. 27 in JAMA.
In addition, spending on pharmaceuticals – particularly diabetes therapies, antihypertensive drugs, and medications for hyperlipidemia – drove much of the massive increase in health care spending during the past 2 decades, said Joseph L. Dieleman, PhD, of the Institute for Health Metrics and Evaluation, University of Washington, Seattle, and his associates.
Recent increases in health care spending are well documented, but less is known about what is spent for individual conditions, in different health care settings, and in various patient age groups. To assess health care spending across these categories, the investigators collected and analyzed data for 1996 through 2013 from nationally representative surveys of households, nationally representative surveys of medical facilities, insurance claims, government budgets, and other official records.
They grouped the data into six type-of-care categories: inpatient care, ambulatory care, emergency department care, nursing facility care, dental care, and prescribed pharmaceuticals. “Spending on the six types of personal health care was then disaggregated across 155 mutually exclusive and collectively exhaustive conditions and 38 age and sex groups,” with each sex being divided into 5-year age groups, the researchers noted.
Based on these data, the investigators came to the following conclusions:
• Twenty conditions accounted for approximately 58% of personal health care spending, which totaled an estimated $1.2 trillion in 2013.
• More resources were spent on diabetes than any other condition in 2013, at an estimated $101.4 billion. Prescribed medications accounted for nearly 60% of diabetes costs.
• The second-highest amount of health care spending was for ischemic heart disease, which accounted for $88.1 billion in 2013. Most such spending occurred in inpatient settings.
• Low-back and neck pain, comprising the third-highest level of spending, cost an estimated $87.6 billion. Approximately 60% of this spending occurred in ambulatory settings.
• Among all 155 conditions, spending for diabetes and low-back and neck pain increased the most during the 18-year study period.
• Among all six types of care, spending on pharmaceuticals and emergency care increased the most during the study period.
It is important to note that for the purposes of this study, cancer was disaggregated into 29 separate conditions, and none of them placed in the top 20 for health care spending, Dr. Dieleman and his associates noted (JAMA. 2016;316[24]:2627-46. doi: 10.1001/jama.2016.16885).
When spending was categorized by patient age groups, working-age adults accounted for the greatest amount spent in 2013, estimated at $1,070.1 billion. But that was followed closely by patients aged 65 and older, who accounted for an estimated $796.5 billion, much of which was spent on care in nursing facilities. The smallest amount of health care spending was in children over age 1 and adolescents, who accounted for an estimated $233.5 billion.
Among the other study findings:
• Spending on pharmaceutical treatment of two conditions, hypertension and hyperlipidemia, increased at more than double the rate of total health care spending. It totaled an estimated $135.7 billion in 2013.
• Other top-20 conditions included falls, depression, skin disorders such as acne and eczema, sense disorders such as vision correction and hearing loss, dental care, urinary disorders, and lower respiratory tract infection.
This work was supported by the National Institute on Aging and the Vitality Institute. Dr. Dieleman and his associates reported having no relevant financial disclosures.
Diabetes, ischemic heart disease, and back and neck pain are the top three conditions accounting for the highest spending on personal health care in the United States, according to a report published online Dec. 27 in JAMA.
In addition, spending on pharmaceuticals – particularly diabetes therapies, antihypertensive drugs, and medications for hyperlipidemia – drove much of the massive increase in health care spending during the past 2 decades, said Joseph L. Dieleman, PhD, of the Institute for Health Metrics and Evaluation, University of Washington, Seattle, and his associates.
Recent increases in health care spending are well documented, but less is known about what is spent for individual conditions, in different health care settings, and in various patient age groups. To assess health care spending across these categories, the investigators collected and analyzed data for 1996 through 2013 from nationally representative surveys of households, nationally representative surveys of medical facilities, insurance claims, government budgets, and other official records.
They grouped the data into six type-of-care categories: inpatient care, ambulatory care, emergency department care, nursing facility care, dental care, and prescribed pharmaceuticals. “Spending on the six types of personal health care was then disaggregated across 155 mutually exclusive and collectively exhaustive conditions and 38 age and sex groups,” with each sex being divided into 5-year age groups, the researchers noted.
Based on these data, the investigators came to the following conclusions:
• Twenty conditions accounted for approximately 58% of personal health care spending, which totaled an estimated $1.2 trillion in 2013.
• More resources were spent on diabetes than any other condition in 2013, at an estimated $101.4 billion. Prescribed medications accounted for nearly 60% of diabetes costs.
• The second-highest amount of health care spending was for ischemic heart disease, which accounted for $88.1 billion in 2013. Most such spending occurred in inpatient settings.
• Low-back and neck pain, comprising the third-highest level of spending, cost an estimated $87.6 billion. Approximately 60% of this spending occurred in ambulatory settings.
• Among all 155 conditions, spending for diabetes and low-back and neck pain increased the most during the 18-year study period.
• Among all six types of care, spending on pharmaceuticals and emergency care increased the most during the study period.
It is important to note that for the purposes of this study, cancer was disaggregated into 29 separate conditions, and none of them placed in the top 20 for health care spending, Dr. Dieleman and his associates noted (JAMA. 2016;316[24]:2627-46. doi: 10.1001/jama.2016.16885).
When spending was categorized by patient age groups, working-age adults accounted for the greatest amount spent in 2013, estimated at $1,070.1 billion. But that was followed closely by patients aged 65 and older, who accounted for an estimated $796.5 billion, much of which was spent on care in nursing facilities. The smallest amount of health care spending was in children over age 1 and adolescents, who accounted for an estimated $233.5 billion.
Among the other study findings:
• Spending on pharmaceutical treatment of two conditions, hypertension and hyperlipidemia, increased at more than double the rate of total health care spending. It totaled an estimated $135.7 billion in 2013.
• Other top-20 conditions included falls, depression, skin disorders such as acne and eczema, sense disorders such as vision correction and hearing loss, dental care, urinary disorders, and lower respiratory tract infection.
This work was supported by the National Institute on Aging and the Vitality Institute. Dr. Dieleman and his associates reported having no relevant financial disclosures.
FROM JAMA
Key clinical point:
Major finding: More resources were spent on diabetes than any other condition in 2013, at an estimated $101.4 billion.
Data source: A comprehensive estimate of U.S. spending on personal health care, based on information collected from nationally representative surveys of households and medical facilities, government budgets, insurance claims, and official records from 1996 through 2013.
Disclosures: The National Institute on Aging and the Vitality Institute supported the work. Dr. Dieleman and his associates reported having no relevant financial disclosures.