In people with the most advanced stage of heart failure, a left ventricular assist device (LVAD) can be life-saving. Once implanted, this mechanical pump helps the heart’s weakened left ventricle, the major pumping chamber of the heart, pump blood throughout the body. The LVAD can be used either as a bridge-to-transplant, to help a patient survive until a donor heart is available; or as destination therapy. “LVADs have been around a long time but in recent years, the devices have improved — and we have gotten better at managing our patients who have them,” says Nader Moazami, MD, Surgical Director of the Cleveland Clinic Kaufman Center for Heart Failure, and Director of the Cardiac Transplantation and Ventricular Assist Device Therapy Program.
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Until very recently, LVADs had only been studied in patients with the most severe form of heart failure—those who are hospitalized and dependent on intravenous inotropic drugs, which stimulate the heart to pump harder and increase the force of its contractions.
Ground-breaking study looks at earlier intervention
A group of clinical researchers — including experts at Cleveland Clinic — recently examined an important question: Could earlier LVAD therapy improve outcomes in patients with advanced heart failure, and do so safely? The results of the first-of-its-kind study, called ROADMAP (Risk Assessment and Comparative Effectiveness of Left Ventricular Assist Device [LVAD] and Medical Management), were recently published in the Journal of the American College of Cardiology.
The study, which included 200 patients from 41 centers across the country, focused on patients with advanced heart failure who had been hospitalized for the condition at least once in the past year and who could walk no more than 300 meters (a little less than ¼ mile) in 6 minutes. About half the patients received an LVAD, and half received optimal medical management (OMM).
While the patients included in the study met all of the Food & Drug Administration’s (FDA’s) requirements for LVAD implantation, their heart failure was less advanced than patients included in previous studies, with none of them dependent on inotropic drugs.
“We wanted to know how patients with heart failure who are less ill would do when an LVAD is implanted earlier,” says Randall C. Starling, MD, MPH, FACC FESC, Head of the Section of Heart Failure and Cardiac Transplant Medicine, and the Medical Director of the Kaufman Center for Heart Failure. “Overall, they did very well, with similar survival rates to the OMM patients at 1 year, and with only a 1 percent risk of dying from the surgery. That’s one of the lowest surgical mortality rates in any LVAD study,” he says. “The LVAD patients also had better functional outcomes and greater improvements in quality of life and depression than those who were treated medically.”
The average hospital stay following LVAD implantation was 17 to 18 days. “When patients come to us more electively — when they aren’t in the ICU on inotropes or a balloon pump — they get through surgery easier,” Dr. Moazami says.
As the lead enrolling center in the clinical trial, Cleveland Clinic researchers played a key role in this ground-breaking study. Dr. Starling also served on the steering committee that designed the study.
Benefits and limitations
The main measure that was used to determine whether treatment was successful was survival on the original therapy with improvement in the patient’s 6-minute walk distance of at least 75 meters at 12 months. More LVAD patients than patients on OMM patients (39 percent versus 21 percent) met that endpoint.
The main limitation of the LVAD therapy was the adverse event rate — primarily due to bleeding, especially GI bleeding — which overall was about twice as high in LVAD versus OMM patients. However, Dr. Moazami points out that the vast majority of adverse events related to bleeding were nonfatal, treatable and manageable, with the exception of stroke.
Dr. Moazami points out that when patients with more advanced heart failure are in the ICU on inotropic therapy and they are given the option of LVAD placement, almost all will say yes. “They feel their back is against the wall, because at that point, it truly is a life and death decision.” With patients who are “still very ill” but aren’t yet in the ICU depend on inotropes, it becomes “more of an individualized decision,” he says.
“It really comes down to what they want their life to be like,” Dr. Moazami says. “If they have a miserable poor quality of life: sitting in a chair all day and can’t catch their breath, they may feel they can’t live like that anymore, and the potential benefits of earlier LVAD therapy may outweigh the risk of adverse events. This device can provide huge advantages by allowing someone to go from being a couch potato to being able to walk to their mailbox or go shopping.”
Patients who are considering LVAD placement receive in-depth counseling and an exhaustive medical work-up to determine if they are good candidates for the therapy. “There’s also a prolonged educational process,” Dr. Moazami says. “We want to ensure that LVAD therapy is right for the patient, and we also involve their family.”
As time goes on and newer generations of LVAD devices are introduced to the market, the risk of adverse events from LVAD therapy likely will become smaller — which could make earlier intervention an even easier decision, Dr. Starling says. Cleveland Clinic is currently participating in a clinical trial testing one of those newer devices.
Dr. Moazami adds: “The future for LVAD therapy is becoming brighter. The technology is getting better, and we’re getting a better understanding of any limitations of the therapy and how to handle them. It’s a great therapy now, and it will be fantastic several years from now.”