The next patient you are seeing in the cardiology office is a 69-year-old male with long standing ischemic cardiomyopathy. He has New York Heart Association Class III-IV symptoms with a left ventricular ejection fraction <20%. Previously, he was on all four main categories of guideline directed medical therapy with initial response but has now developed worsening heart failure symptoms despite escalation of medical therapy. On your last visit, you referred him to the heart failure team for consideration of advanced therapies. Unfortunately, he was not a candidate for heart transplant due to elevated body mass index as well as poorly controlled diabetes mellitus. However, left ventricular assist device therapy (LVAD) was offered. He was provided educational material on the HeartMate3™ (HM3, Abbott, Abbott Park, IL) device. Today, the patient asks for your guidance on this therapy option.
You provide him the following counsel:
Show Answer
The correct answer is: C. Compared to prior centrifugal pumps, the HM3 has a better hemocompatibility profile with decreased events of pump thrombosis, stroke, and bleeding.
The HM3 pump is the only LVAD currently being implanted in the United States.1-3 The initial randomized control trial supporting its use was published in 2019.4 Patients were randomized to receive either the HM3 or the HeartMate®II (HMII, Thoratec Corp, Pleasanton, CA) axial flow pump. Unlike prior studies, the MOMENTUM 3 trial enrolled patients who were receiving LVAD therapy as both a "bridge to transplant" or a "destination therapy". The primary endpoint was survival free from disability stroke or re-operation to repair/replace the pump at 24 months. This was reported in 74.7% HM3 versus 60.6% HMII patients (hazard ratio [HR] 0.60; 95% confidence interval [CI] 0.47 – 0.75) and statistically met both non-inferiority and superiority margins. Actual survival was similar between pumps (79.0% vs. 76.7%, HR 0.88; 95% CI 0.67-1.16) but stroke of any severity, pump thrombosis, major bleeding and gastrointestinal hemorrhage were significantly lower in the HM3 group.
Recently, at the 2022 European Society of Cardiology Congress, 5-year follow up results were presented.5 Follow-up data were available for 457/515 (88.7%) HM3 and 440/505 (87.1%) HMII of the original cohort patients. The primary endpoint was overall survival with additional endpoints matching those of the initial trial. At 5 years, the overall survival was 58.4% versus 43.7% in the HM3 versus HMII groups respectively, with a HR 0.72 (95% CI 0.58-0.89, p=0.003). Even for patients with a destination therapy pump designation, survival benefit was seen with HM3 (54.8% vs. 39.4%, HR 0.70; 95% CI 0.55-0.90, p=0.005). Likewise, HM3 pulled ahead for the composite endpoint of event free survival from disabling stroke or need for reoperation (54.0% vs. 29.7%, HR 0.55; 95% CI 0.45- 0.67, p< 0.001). Hemocompatibility events including any stroke, bleeding or pump thrombosis were also statistically lower with the HM3 as seen previously in the 2-year study (p<0.001).
Both study results affirm that HM3 therapy is a safe and life prolonging alternative for patients with end stage heart failure who are not candidates for heart transplantation.
References
Stawiarski K, Stulak JM, Ramakrishna H. HeartMate 3 ΜΆ analysis of recent trial data. J Cardiothorac Vasc Anesth 2021;35:3105-07.
Molina EJ, Shah P, Kiernan MS, et al. The Society of Thoracic Surgeons Intermacs 2020 Annual Report. Ann Thorac Surg 2021;111:778-92.
Mehra MR, Uriel N, Naka Y, et al. A fully magnetically levitated left ventricular assist device: final report. N Engl J Med 2019;380:1618–27.
Mehra MR, Golstein DJ, Cleveland JC, et al. Five-year outcomes in patients with fully magnetically levitated vs axial-flow left ventricular assist devices in the MOMENTUM-3 randomized trial. Presented by Dr. Mandeep R. Mehra at the European Society of Cardiology Congress (ESC 2022), Barcelona, Spain, August 28, 2022.
Log in to MyACC
