title: Platelet activation is a preoperative risk factor for the development of thromboembolic complications in patients with continuous‐flow left ventricular assist device Intrapericardial Left Ventricular Assist Device for Advanced Heart Failure HeartWare ventricular assist system for bridge to transplant: combined results of the bridge to transplant and continued access protocol trial.
abstract: AIMS To correlate the dynamics of platelet activation with the development of thromboembolic events in patients with continuous-flow left ventricular assist device ( cf-LVAD ) . METHODS AND RESULTS The  platelet activity state ( PAS ) assay  was utilized to evaluate platelet activation in 68 cf-LVAD patients implanted with the HeartMate II ( n = 15 , 22 % ) , HeartMate 3 ( n = 15 , 22 % ) , or HeartWare HVAD ( n = 38 , 56 % ) .  PAS  was measured preoperatively , early post-implant , and at long-term follow-up ( 1 , 3 , 6 , 12 , 18 , and 24 months post-implant ) .  PAS  was also measured at the occurrence of adverse events in patients who developed thrombotic complications . Data on patient demographics , medical history , antithrombotic therapy , and coagulation parameters were also analysed . Over a median follow-up of 602 ( 234 - 942 ) days , PAS values did not increase over time in the overall population ( P = 0.15 ) . However , PAS measured at event was 15-fold higher in the six patients ( 9 % ) who suffered pump thrombosis ( n = 2 ) or ischaemic stroke ( n = 4 ) vs. the rest of the population [ 6.67 % ( 5.59%-11.98 % ) vs. 0.45 % ( 0.33%-0.75 % ) ; P = 0.012 ] , despite comparable coagulation profile . Pre-implant PAS values were 4.5-fold higher in these patients [ 1.90 % ( 1.24%-3.17 % ) vs. 0.42 % ( 0.32%-0.72 % ) ; P = 0.006 ] . Neither preoperative variables nor the type of the pump or the antiplatelet strategy were associated with a higher risk of complications . CONCLUSIONS Thrombotic events are associated with altered PAS values . Moreover , baseline elevated PAS values in patients who developed thrombotic events suggest patient-specific tendency to post-implant thromboembolic complications . Prospect ively , systematic monitoring of PAS might guide the development of refined patient-tailored antithrombotic strategies and the technological improvement of LVAD design 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 . BACKGROUND The HeartWare Ventricular Assist System ( HeartWare Inc , Framingmam , MA ) is a miniaturized implantable , centrifugal design , continuous-flow blood pump . The pivotal bridge to transplant and continued access protocol s trials have enrolled patients with advanced heart failure in a bridge-to-transplant indication . METHODS The primary outcome , success , was defined as survival on the originally implanted device , transplant , or explant for ventricular recovery at 180 days . Secondary outcomes included an evaluation of survival , functional and quality of life outcomes , and adverse events . RESULTS A total of 332 patients in the pivotal bridge to transplant and continued access protocol s trial have completed their 180-day primary end-point assessment . Survival in patients receiving the HeartWare pump was 91 % at 180 days and 84 % at 360 days . Quality of life scores improved significantly , and adverse event rates remain low . CONCLUSIONS The use of the HeartWare pump as a bridge to transplant continues to demonstrate a high 180-day survival rate despite a low rate of transplant . Adverse event rates are similar or better than those observed in historical bridge-to-transplant trials , despite longer exposure times due to longer survival and lower transplant rates
target: 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
background: 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 .