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Intrapericardial Left Ventricular Assist Device
Study Questions:
What are the outcomes with a newer left ventricular assist device (LVAD) design (a small intrapericardial centrifugal-flow device), as compared with existing technology (a commercially available axial-flow device) in patients with advanced heart failure who were ineligible for heart transplantation?
Methods:
The ENDURANCE trial investigators conducted a multicenter randomized trial involving 446 patients who were assigned, in a 2:1 ratio, to the study (centrifugal-flow) device or the control (axial-flow) device. Adults who met contemporary criteria for LVAD implantation for permanent use were eligible to participate in the trial. The primary endpoint was survival at 2 years free from disabling stroke or device removal for malfunction or failure. The trial was powered to show noninferiority with a margin of 15 percentage points.
Results:
The intention-to-treat population included 297 participants assigned to the study device and 148 participants assigned to the control device. The primary endpoint was achieved in 164 patients in the study group and 85 patients in the control group. The analysis of the primary endpoint showed noninferiority of the study device relative to the control device (estimated success rates, 55.4% and 59.1%, respectively, calculated by the Weibull model; absolute difference, 3.7 percentage points; 95% upper confidence limit, 12.56 percentage points; p = 0.01 for noninferiority). More patients in the control group than in the study group had device malfunction or device failure requiring replacement (16.2% vs. 8.8%), and more patients in the study group had strokes (29.7% vs. 12.1%). Quality of life and functional capacity improved to a similar degree in the two groups.
Conclusions:
The authors concluded that a small, intrapericardial, centrifugal-flow LVAD was found to be noninferior to an axial-flow LVAD with respect to survival free from disabling stroke or device removal for malfunction or failure.
Perspective:
This study reports that an intrapericardial centrifugal-flow device was found to be noninferior to the axial-flow device with respect to survival free from disabling stroke or need for device replacement. However, the centrifugal device was associated with more strokes, right heart failure, and sepsis, whereas the axial device was associated with more frequent device malfunction or failure requiring surgical intervention. It should be noted that this trial did not address the durability of the devices beyond 2 years, and longer-term data are needed since patients who are not eligible for transplantation typically need lifelong LVAD support.
Keywords: Cardiac Surgical Procedures, Device Removal, Equipment Failure, Heart-Assist Devices, Heart Failure, Heart Transplantation, Quality of Life, Sepsis, Stroke
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