TY  - BOOK
AU  - Boyce, Steven W
AU  - Najjar, Samer S
TI  - Intrapericardial Left Ventricular Assist Device for Advanced Heart Failure
SN  - 0028-4793
PY  - 2017///
KW  - *Heart Failure/th [Therapy]
KW  - *Heart-Assist Devices
KW  - Adult
KW  - Aged
KW  - Disease-Free Survival
KW  - Heart Failure/mo [Mortality]
KW  - Heart-Assist Devices/ae [Adverse Effects]
KW  - Humans
KW  - Intention to Treat Analysis
KW  - Kaplan-Meier Estimate
KW  - Middle Aged
KW  - Prosthesis Design
KW  - Prosthesis Failure
KW  - Quality of Life
KW  - Stroke/et [Etiology]
KW  - MedStar Heart & Vascular Institute
KW  - Comparative Study
KW  - Journal Article
KW  - Multicenter Study
KW  - Randomized Controlled Trial
KW  - Research Support, Non-U.S. Gov't
N1  - Available online from MWHC library: 1993 - present, Available in print through MWHC library: 1980 - present
N2  - Background Mechanical circulatory support with a left ventricular assist device (LVAD) is an established treatment for patients with advanced heart failure. We compared a newer LVAD design (a small intrapericardial centrifugal-flow device) against existing technology (a commercially available axial-flow device) in patients with advanced heart failure who were ineligible for heart transplantation. Methods We 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 end point 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 end point was achieved in 164 patients in the study group and 85 patients in the control group. The analysis of the primary end point 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 In this trial involving patients with advanced heart failure who were ineligible for heart transplantation, 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. (Funded by HeartWare; ENDURANCE ClinicalTrials.gov number, NCT01166347 .)
UR  - https://dx.doi.org/10.1056/NEJMoa1602954
ER  -