AF in CF-LVAD patients was not associated with overall TE , stroke , or device thrombosis events .
These findings might be explained by the highly thrombogenic property of CF-LVADs that exceeds the thromboembolic risk driven by AF
Atrial fibrillation ( AF ) is a well-established risk factor of thromboembolism ( TE ) .
Thromboembolism is one of the most common complications in patients supported by continuous-flow left ventricular assisted devices ( CF-LVADs ) .
However , the association between AF and TE complications in this population is controversial .
We conducted a systematic review and meta- analysis to assess the association between AF and overall TE , stroke , and device thrombosis events in CF-LVAD patients .
Intrapericardial Left Ventricular Assist Device for Advanced Heart Failure
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 r and omized 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 Clinical Trials.gov number , NCT01166347 .
AF in CF-LVAD patients was not associated with overall TE , stroke , or device thrombosis events .
These findings might be explained by the highly thrombogenic property of CF-LVADs that exceeds the thromboembolic risk driven by AF
Atrial fibrillation ( AF ) is a well-established risk factor of thromboembolism ( TE ) .
Thromboembolism is one of the most common complications in patients supported by continuous-flow left ventricular assisted devices ( CF-LVADs ) .
However , the association between AF and TE complications in this population is controversial .
We conducted a systematic review and meta- analysis to assess the association between AF and overall TE , stroke , and device thrombosis events in CF-LVAD patients .