Platelet activation is a preoperative risk factor for the development of thromboembolic complications in patients with continuous‐flow left ventricular assist device Thromboembolic event rate in paroxysmal and persistent atrial fibrillation: Data from the GISSI-AF trial Detection of atrial high-rate events by continuous Home Monitoring: clinical significance in the heart failure–cardiac resynchronization therapy population
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 Few data on the thromboembolic ( TE ) risk of paroxysmal and persistent atrial fibrillation ( AF ) are available . This study aim ed to assess the incidence of TE events in paroxysmal and persistent AF . Methods We performed a subset post hoc analysis of 771 patients with paroxysmal and 463 with persistent AF enrolled in the multicenter , prospect i ve , r and omized , double-blind , placebo-controlled GISSI-AF trial - comparing the efficacy of valsartan versus placebo in preventing AF recurrences – where the choice of antithrombotic treatment was left to the judgment of the referring physician . TE and major outcome events were central ly vali date d. AF recurrences were detected by frequent clinic visits and a transtelephonic monitoring device with weekly and symptomatic transmissions . Results Eighty-five percent of patients had a history of hypertension , and the 7.7 % had heart failure , left ventricular dysfunction , or both .  The mean CHADS2 score was 1.41±0.84 . TE and major bleeding events were observed at a low incidence among the overall population at 1-year follow-up ( 0.97 % and 0.81 % , respectively ) . The univariate and multivariable analyses revealed no statistically significant differences in the incidence of TE , major bleeding events or mortality in paroxysmal and persistent AF patients . TE events were more common among women than men ( p=0.02 ) . The follow-up examination showed under- or overtreatment with warfarin in many patients , according to guideline suggestions . Warfarin was more frequently prescribed to patients with persistent AF ( p<0.0001 ) and patients with AF recurrences ( p<0.0001 ) . AF recurrences were noninvasively detected in 632 ( 51.2 % ) patients . In patients without AF recurrences , the TE event rate was 0.5 % versus 1.74 % , 1.28 % , and 1.18 % for those with only symptomatic , only asymptomatic or both symptomatic and asymptomatic AF recurrences , respectively , but the difference was not statistically significant , even after adjusting for warfarin treatment and the CHADS2 score ( HR 2.93 ; CI 95 % ; 0.8 - 10.9 ; p=0.11 ) . Conclusions TE and major bleeding events showed a very low incidence in the GISSI-AF trial population , despite under- or overtreatment with warfarin in many patients . TE events had a similar rate in paroxysmal and persistent AF.Trial registration Trial registration number : Aims Uncertainty exists over the importance of device-detected short- duration atrial arrhythmias . Continuous atrial diagnostics , through home monitoring ( HM ) technology ( BIOTRONIK , Berlin , Germany ) , provides a unique opportunity to assess frequency and quantity of atrial fibrillation ( AF ) episodes defined as atrial high-rate events ( AHRE ) . Methods and results Prospect i ve data from 560 heart failure ( HF ) patients ( age 67 ± 10 years , median ejection fraction 27 % ) patients with a cardiac resynchronization therapy ( CRT ) device capable of HM from two multi-centre studies were analysed . Atrial high-rate events burden was defined as the duration of mode switch in a 24-h period with atrial rates of > 180 beats for at least 1 % or total of 14 min per day . The primary endpoint was incidence of a thromboembolic ( TE ) event . Secondary endpoints were cardiovascular death , hospitalization because of AF , or worsening HF . Over a median 370-day follow-up AHRE occurred in 40 % of patients with 11 ( 2 % ) patients developing TE complications and mortality rate of 4.3 % ( 24 deaths , 16 with cardiovascular aetiology ) . Compared with patients without detected AHRE , patients with detected AHRE>3.8 h over a day were nine times more likely to develop TE complications ( P= 0.006 ) . The majority of patients ( 73 % ) did not show a temporal association with the detected atrial episode and their adverse event , with a mean interval of 46.7 ± 71.9 days ( range 0–194 ) before the TE complication . Conclusion In a high-risk cohort of HF patients , device-detected atrial arrhythmias are associated with an increased incidence of TE events . A cut-off point of 3.8 h over 24 h was associated with significant increase in the event rate . Routine assessment of AHRE should be considered with other data when assessing stroke risk and considering anti-coagulation initiation and should also prompt the optimization of cardioprotective HF therapy in CRT patients
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 .