A patient who received the HeartMate III LVAD system showing off his external battery pack. He served as a patient ambassador in the Abbott booth at ACC.18. The HeartMate III, with its magnetic levitated pump, showed a big reduction in clotting over previous LVADs in a key late-breaking trial at this year's conference.
There were several notable presentations of new data on cardiovascular technologies at the recent 2018 American College of Cardiology (ACC) meeting. Here are a few of the key studies highlighted in the late-breaking trials at ACC.18.
Wearable Defibrillator Cuts Overall Mortality, But Not Sudden Deaths After Heart Attack
The Vest Prevention of Early Sudden Death Trial (VEST) was the first randomized, controlled, multi-center trial of the Zoll LifeVest wearable cardioverter defibrillator (WCD). It was designed to test if this device could effectively reduce sudden death in patients who had recently suffered a heart attack and had reduced ejection fraction of 35 percent or less. In many cases, ejection fractions will improve in the months after a heart attack, but there is a high rate of sudden death during the first three months following a heart attack. Implantable cardioverter defibrillators (ICDs) are not indicated for this patient population before 40-90 days, mainly due to the high recovery rate. The VEST study showed 60 percent of patients recovered and no longer met the criteria for an ICD at 90 days.
“There is a very high risk of death immediately after a heart attack that tails off after about three months,” said Jeffrey E. Olgin, M.D., professor and chief of cardiology, University of California San Francisco, and lead author of the study. “The challenge is that we don’t currently have a good way of preventing deaths during this very vulnerable period.”
Generally, the three-month mortality rate for people recovering from a heart attack who also have reduced heart function on optimal medical therapy is around 5 percent, Olgin said. In VEST, 4.9 percent of participants in the control group died compared with only 3.2 percent of those wearing the WCD — an absolute difference of 1.7 percent.
“It is possible that sudden deaths were misclassified as it’s difficult to define sudden death with accuracy when a death is unwitnessed and there is little documentation,” Olgin said. “But the cause of death is irrelevant if we can prevent it. This study found that the device was associated with fewer deaths among people recovering from a heart attack with low ejection fraction. It’s also the first therapy associated with a mortality benefit above and beyond standard medical therapy immediately after heart attack.”
Data from the trial showed an overall 35 percent reduction in death for any reason in patients wearing the Zoll LifeVest compared with those who received medications alone. However, the study did not find a significant benefit in terms of reducing sudden cardiac death, the primary endpoint
Heart Attack Risk Increases With Six-month Dual Antiplatelet Therapy
There is a big interest in reducing dual antiplatelet therapy (DAPT) following the placement of a drug-eluting stent and there are several ongoing trials looking at the safety of this strategy. The late-breaking SMART-DATE Study enrolled 2,712 Korean patients and is the largest trial to date looking at using six months vs. 12 months of DAPT. While the combined rate of death from any cause, heart attack or stroke within 18 months was not significantly different in the two groups, patients with a six-month duration had more than double the risk of a heart attack.
The risk of heart attack was 2.4-fold higher in the DAPT six-month group. Heart attacks occurred in 1.8 percent of DAPT six-month patients versus 0.8 percent of DAPT 12-month patients. Patients in the six-month group also had a 69 percent higher risk of dying from any cause or having a heart attack or stroke.
“Based on our findings, we can’t say that short-term DAPT is safe in patients with acute coronary syndromes [ACS] who have received drug-eluting stents,” said Hyeon Cheol Gwon, M.D., a professor in the Division of Cardiology at Sungkyunkwan University, director of the cardiac center at Samsung Medical Center in Seoul, South Korea, and principal investigator of the study. “We conclude that current guidelines that recommend prolonged DAPT in patients with ACS who are not at excessive risk for bleeding should continue to be followed.”
Reduced LVAD Clotting, Decreased Strokes With HeartMate 3
At two years of follow-up, severely ill patients with advanced heart failure who received Abbott’s fully implantable HeartMate 3 left ventricular assist device (LVAD) experienced no malfunctions requiring replacement or removal of the device for blood clotting. The risk of stroke was cut in half compared with patients who received the previous-generation HeartMate II pump, which required an abdominal location for the implant.
The new device tested in the MOMENTUM-3 Trial is the first to use fully magnetic levitation technology, which replaces mechanical bearings and makes the pump frictionless. The trial enrolled 1,028 patients at 69 centers in the U.S.
“We saw a marked decrease in pump malfunction requiring re-operation, mostly driven by an absence of confirmed pump thrombosis, and a halving of observed stroke rates in patients implanted with the HeartMate 3 compared with patients who were implanted with the HeartMate 2,” said Mandeep R. Mehra, M.D., medical director of the Heart and Vascular Center, Brigham and Women’s Hospital in Boston and lead author of the study.
Although the trial was designed to show only that outcomes with the HeartMate 3 were no worse than those with the HeartMate II, the results demonstrate that outcomes are, in fact, clearly superior with the HeartMate 3 than with the standard device, he said.
Some patients in the study needed an LVAD to sustain them until they were able to receive a heart transplant. Others, because of age or other health problems, were not candidates for a transplant and relied on an LVAD as a destination therapy. The study found 82.8 percent of HeartMate III patients were alive at two years, compared with 76.2 percent of HeartMate II patients, Mehra said. One percent of HeartMate III patients needed additional surgery to remove or replace the device (due to an electrical or mechanical malfunction), compared with 17 percent of HeartMate II patients (two-thirds of which were for pump clotting).
Watch the VIDEO “Therapies for Advanced Heart Failure,” an interview with David Lanfear, M.D., FACC, head of advanced heart failure and cardiac transplantation, Henry Ford Hospital, Detroit, who discusses LVAD support technologies at the 2018 American College of Cardiology (ACC) meeting.
His Bundle Pacing vs. Right Ventricular Pacing
Permanent His bundle pacing (HBP) was found feasible and safe in a large, real-world population requiring permanent pacemakers. This was the finding of a late-breaking presentation on the Geisinger His Bundle Pacing Registry data collected between 2013-2016. Right ventricular pacing (RVP) is associated with heart failure and increased mortality, and this study looks at using HBP as an alternative.
HBP was successful in 304 of 332 (92 percent) consecutive patients. The study also included 433 patients who underwent RVP. The primary endpoint of death, heart failure hospitalization or upgrade to biventricular pacing was significantly reduced in the HBP group to 25 percent, compared to 32 percent of the RVP group. This difference was primarily in patients with ventricular pacing.
The incidence of heart failure hospitalization was significantly reduced in HBP, 12.4 vs 17.6 percent. There also was a trend toward reduced mortality in HBP (17.2 vs. 21.4 percent).
Adhesive Chest Patch Catches AFib Earlier Than Usual Care
The expo floor at ACC.18 had numerous vendors showing self-adhering chest patch wearable heart monitors. A late-breaking trial on one of these devices showed the device was capable of identifying atrial fibrillation (AFib) heart patterns to enable diagnosis and treatment faster than relying on usual care. This was according to one-year data presented from the mHealth Screening to Prevent Strokes (mSToPS) trial.
The study is one of the first completely digital, nationwide, direct-to-participant and site-less clinical research programs. Patients consented and enrolled exclusively via a web-based platform to undergo active monitoring at home using the iRhythm Zio patch. The patch, about the size of a large Band-Aid, continuously records an electrocardiogram (ECG). But instead of only providing a brief snapshot of someone’s heart rhythm — which is often the case with an ECG in the clinic — this technology allowed researchers to collect 14 consecutive days of data capturing the electrical activity of an individual’s heart.
“At one year, people who wore the chest monitor had nearly three times the likelihood of being diagnosed with AFib. A significantly higher proportion of these patients were started on anticoagulant therapy to lower their stroke risk compared with those who received usual care,” said Steven R. Steinhubl, M.D., director of digital medicine, Scripps Translational Science Institute, La Jolla, Calif., and lead author of the study. “The data also provide a first glimpse into how this type of ECG screening might influence heart care utilization.”
iFR More Cost-Effective Than FFR
An economic analysis of the DEFINE FLAIR clinical trial compared the cost-effectiveness between instant wave-free ratio (iFR) and fractional flow reserve (FFR) in the guidance of treatment of ischemic heart disease. The study found iFR offered a one-year average cost savings of $896 per patient compared to an FFR-guided strategy. Both methods to determine the impact of lesions on coronary blood flow delivered consistent patient outcomes, according to the study.
The study found that iFR offers a total procedure cost saving of about 10 percent per patient over FFR. Additionally, patients treated with the use of an iFR-guided revascularization strategy had fewer coronary artery bypass graft procedures and fewer subsequent revascularizations. Previous data from DEFINE FLAIR released in 2017 found that iFR-guided treatments reduced procedure time by 10 percent versus FFR-guided treatments, while reducing patient discomfort by 90 percent because it eliminates the use of the pharmacologic stress agent adenosine.
"The findings from DEFINE FLAIR continue to demonstrate the benefits of iFR, showing that an iFR-guided treatment offers proven outcomes, reduced costs and procedure time, and enhanced patient comfort compared to FFR," said Manesh Patel, M.D., FACC, FSCAI, chief of the division of cardiology and co-director of the Duke Heart Center at Duke University School of Medicine. "iFR is not only a faster diagnostic solution, but it also offers the advantage of significantly reduced patient discomfort. By implementing an iFR program at a hospital, this solution can deliver the clinical outcome benefits of physiology-driven PCI, while reducing annual healthcare costs significantly across the organization."
DEFINE FLAIR is a randomized, controlled, single-blinded comparison of clinical outcomes and cost efficiencies of iFR and FFR-guided interventions of 2,492 patients in 49 centers across Europe, Asia, North America and Africa.
Managing Blood Pressure in Black Barbershops
One study with an interesting and unique approach to patient engagement was through barber shops. African-American men who received medical intervention aimed at controlling their high blood pressure while at the barber saw a marked drop in blood pressure in just six months. Men who received frequent monitoring and medication management from a specially-trained pharmacist who met them monthly in their barbershop lowered their systolic blood pressure by 21 mm Hg or more, on average, compared with men who were encouraged by their barber to follow up with a doctor and to make healthy lifestyle choices. The study was presented by Ronald G. Victor, M.D., associate director of the Smidt Heart Institute at Cedars-Sinai.
African-American men are more likely than other groups to have high blood pressure that is not adequately controlled and tend to have less contact with the healthcare system.
“By bringing state-of-the-art medicine directly to the people who need it on their home turf, in this case in a barbershop, and making it both convenient and rigorous, blood pressure can be controlled just as well in African-American men as in other groups,” Victor explained. “If this model was scaled up and sustained, millions of lives could be saved, and many heart attacks and strokes could be prevented.”
Previous studies have shown that equipping barbers — who remain trusted, consistent and convenient influencers for many African-American men — with health information can positively affect health. The new study is unique because it combined barbershop-based health outreach with the delivery of care by medical professionals at the barbershop and evaluated subsequent efficacy with a randomized trial.
Trial Supports Closing PFOs After Stroke
There has been debate about whether to use transcatheter closure devices to seal patent foramen ovale (PFO) in patients after they suffer a stroke.
A late-breaking trial at ACC.18 may help boost closure, with a noticeable reduced stroke rate at two years, compared with those who received anticoagulants alone.
Researchers stopped enrollment for the trial early after determining, based on the results of several recent trials, that it would be unethical to continue assigning some patients to not receive the PFO closure device in light of mounting evidence of its clear benefits. Despite the smaller-than-expected number of participants, researchers said the new trial helps clarify which patients are likely to benefit most from the medical device based on the physical characteristics of their PFO.
“Considering the high prevalence of PFO in the general population and cryptogenic stroke patients, the key to appropriate use of this medical device is determining how to select optimal candidates for the procedure,” said Jae Kwan Song, M.D., a cardiologist at Asan Medical Center in Seoul, South Korea, and the study’s lead author. “Our study showed that the potential benefit from closure can be determined on the basis of the size of the PFO and the movement of the heart wall around the PFO.”
The trial enrolled 120 patients at two centers in South Korea. All patients had recently experienced a cryptogenic stroke and were found to have a high-risk PFO, meaning either the PFO was 2 millimeters across (about the size of a peppercorn) or larger, or the PFO was accompanied by an outgrowth of tissue protruding into one of the heart’s chambers.
The study’s primary endpoint was a composite of stroke, major bleeding events and death from vascular causes (death related to the blockage or rupture of blood vessels). While no such events occurred in the 60 patients receiving PFO closure, among the 60 patients receiving medications alone, six had a stroke and one had a transient ischemic attack, or “mini-stroke.” These results suggest that treating 10 PFOs with a closure device would be expected to prevent, on average, about one stroke after two years.
“We believe that PFO closure should be done in selected patients with cryptogenic stroke and PFO,” Song said. “With our study and other recent trials, the criteria for selecting patients for the procedure are becoming clearer; in particular, the results suggest that closure is beneficial for those with high-risk PFO.”