An Experimental Ventricular Assist Device for Heart Failure

Summary and Comment |
February 16, 2017

An Experimental Ventricular Assist Device for Heart Failure

  1. Frederick A. Masoudi, MD, MSPH, FACC, FAHA

The device was noninferior to an FDA-approved device, but patients need devices that pose fewer risks.

  1. Frederick A. Masoudi, MD, MSPH, FACC, FAHA

Although left ventricular assist devices (LVADs) have revolutionized the treatment of advanced heart failure and the technology has improved over time, they are by no means a cure. Because deaths and complications (e.g., thromboembolism, device failure, and infection) remain common after LVAD implantation, investigators continue to search actively for better devices (e.g., NEJM JW Cardiol Jan 2017 and N Engl J Med 2017; 376:440). The current study, a randomized, manufacturer-sponsored, noninferiority trial (#NCT01166347), compared an FDA-approved axial-flow LVAD (HeartMate II) with an experimental, non–FDA-approved, intrapericardial centrifugal-flow device. The 446 patients had severe symptomatic systolic heart failure ineligible for cardiac transplantation for whom LVAD was recommended (i.e., “destination” therapy; mean age, 63; 77% men; mean LV ejection fraction, 16%; ischemic etiology, 57%).

The primary combined 2-year endpoint (survival free of disabling stroke and without device removal for malfunction or failure) occurred in 55.4% of the experimental-device group and 59.1% in the control group; the finding met pre-specified criteria for noninferiority. Fewer intrapericardial-device patients required device removal (8.8% vs. 16.2%). Disabling stroke occurred in three patients (all in the experimental group). Still, the intrapericardial-device group had a significantly higher proportion of patients with any ischemic or hemorrhagic stroke (29.7% vs. 12.1%), as well as significantly higher rates of clinical right heart failure and sepsis.

Comment

Although an intrapericardial centrifugal-flow LVAD was noninferior to an established axial-flow device, the two treatments involved trade-offs on individual or secondary outcomes. Further, a finding of noninferiority is not entirely encouraging, especially if the new device is more expensive. The editorialists appropriately laud the investigators who surmounted the many challenges particular to randomized trials of this technology. Nevertheless, we still need better mechanical support for advanced heart failure that reduces the risks for LVADs' feared complications.

Editor Disclosures at Time of Publication

  • Disclosures for Frederick A. Masoudi, MD, MSPH, FACC, FAHA at time of publication Grant / Research support National Heart, Lung, and Blood Institute; American College of Cardiology; Patient-Centered Outcomes Research Institute; John. A. Hartford Foundation Editorial boards Circulation: Cardiovascular Quality and Outcomes Leadership positions in professional societies American College of Cardiology (Chief Science Officer, National Cardiovascular Data Registries; Member, Board of Trustees); American Heart Association (Immediate Past Chair, Council on Quality of Care and Outcomes Research); American Board of Internal Medicine (Member, Cardiology Board)

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