The FRANCE TAVI registry provided reassuring data regarding trends in TAVR performance in an all-comers population on a national scale. Nonetheless, given that TAVR indications are likely to expand to patients at lower surgical risk, concerns remain regarding potentially life-threatening complications and pacemaker implantation. (Registry of Aortic Valve Bioprostheses Established by Catheter [FRANCE TAVI]; NCT01777828).

The presence of HMW-multimer defects and a high value for a point-of-care hemostatic test, the CT-ADP, were each predictive of the presence of aortic regurgitation after TAVR and were associated with higher mortality 1 year after the procedure. (Funded by Lille 2 University and others; ClinicalTrials.gov number, NCT02628509.).

We demonstrated that the VWF defect reflects the balance between degradation induced by the shear stress and the endothelial release of new VWF triggered by the pulsatility. This modulation of VWF levels could explain the relationship between pulsatility and bleeding observed in CF-MCS recipients. Preservation of pulsatility may be a new target to improve clinical outcomes of patients.

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Background: No randomized study powered to compare balloon-expandable (BE) with self-expanding (SE) transcatheter heart valve (THV) on individual endpoints after transcatheter aortic valve replacement (TAVR) has been conducted to date. Methods: From January 2013 to December 2015, the FRANCE-TAVI nationwide registry included 12,141 patients undergoing BE-THV (Edwards, n=8038) or SE-THV (Medtronic, n=4103) for native aortic stenosis (AS). Long-term mortality status was available in all patients (median 20 months, IQR:14-30). Patients treated with BE-THV (n=3910) were successfully matched 1:1 with 3910 patients treated with SE-THV by using propensity-score (25 clinical, anatomical and procedural variables) and by date of the procedure (within 3 months). The first co-primary outcome was the occurrence of paravalvular regurgitation (PVR)≥moderate and/or in-hospital mortality. The 2 nd co-primary outcome was 2-year all-cause mortality. Results: In matched-propensity analyses, the incidence of the 1st co-primary outcome was higher with SE-THV (19.8%) compared with BE-THV(11.9%; RR=1.68; 95%CI:1.46-1.91; p<0.0001). Each component of the outcome was also higher in SE-THV patients: PVR≥moderate (15.5% vs. 8.3%; RR=1.90; 95% CI:1.63-2.22; p<0.0001) and in-hospital mortality (5.6% vs 4.2%, RR=1.34; 95%CI:1.07-1.66; p=0.01). During follow-up, all-cause mortality occurred in 899 patients treated with SE-THV (2-year mortality was 29.8%) and in 801 patients treated with BE-THV (2-year mortality 26.6%; HR=1.17; 95% CI:1.06-1.29; p=0.003). Similar results were found using inverse probability of treatment weighting using propensity score analysis. Conclusions: The present study suggests that use of SE-THV was associated with a higher risk of PVR and higher in-hospital and 2-year mortality as compared with BE-THV. These data strongly support the need for a randomized trial sufficiently powered to compare head-to-head the latest generation of SE and BE-THV.

We thank Drs Iqbal and Serruys for their interesting comments on our study.1 Transcatheter aortic valve replacement is a very good alternative to conventional surgical replacement in patients with aortic stenosis at increased risk for surgery. 2,3 As efficient as it is, transcatheter aortic valve replacement has important limitations, including postprocedural aortic regurgitation (AR). Our study was designed to (1) describe the rate of postprocedural AR evaluated at discharge in a large series of consecutive patients treated with balloon-expandable (BE) and self-expandable devices, (2) analyze the predictors of postprocedural ARs in the overall population for each device, and (3) analyze the impact of postprocedural ARs on clinical outcome.The results of our study 1 and others 2 demonstrate clearly that postprocedural AR≥moderate as evaluated by echocardiography at discharge is frequent (15%) and is an independent predictor of long-term mortality. Our study demonstrates also that the clinical significance of a postprocedural AR≥moderate is similar in patients treated with a BE or a self-expandable device, with an hazards ratio for 1-year mortality of 2.5 and 2.1, respectively.It was suggested that postprocedural AR could regress over time, in particular after the implantation of a self-expandable device, thus minimizing the clinical impact of postprocedural AR. Although a serial echocardiography analysis of the CoreValve-Extreme-RiskPivotal-Trial 4 suggested that such late regression could occur, the CoreValve-High-Risk-Pivotal-Trial 3 was less conclusive. In that study, postprocedural AR≥moderate was observed in 9.1% (33/363) at discharge, in 10% (36/356) at 1 month, and in 7.0% (21/291) at 1 year (Supplementary Table S10).3 These figures do not show any regression of postprocedural AR between discharge and 1 month, but the apparent trend observed between 1 month and 1 year could have been as likely attributable to the increased mortality in patients with AR as to a real regression of AR between 1 month and 1 year. The absence of regression of postprocedural AR during the first month 3,4 together with our finding that a postprocedural AR≥moderate at discharge is associated with the same extrarisk of mortality by 1 year for both devices demonstrates that the evaluation of AR at discharge is clinically relevant and suggests that the late regression of AR, if it occurs, is too late to impact mortality.As pointed out, despite a lower rate of postprocedural AR in a BE device, 1,5 there is no clear evidence that implantation of a BE rather than a self-expandable device is associated with a survival advantage. Although there is no definite explanation to this observation, it is likely that some other differences could obviate the benefit of a lower rate of postprocedural AR. Trans apical delivery, which is associated with a high 1-year mortality, and aortic annulus rupture, which is a deadly complication, are highly specific to BE devices and are among the potential candidates. This unanswered question should not mini...

The transcarotid approach for TAVR is feasible using general or local anesthesia. A higher rate of perioperative strokes was observed with GA.

Rationale: Percutaneous aortic valve procedures are a major breakthrough in the management of patients with aortic stenosis. Residual gradient and residual aortic regurgitation are major predictors of midterm and long-term outcome after percutaneous aortic valve procedures. We hypothesized that (1) induction/recovery of high molecular weight (HMW) multimers of von Willebrand factor defect could be instantaneous after acute changes in blood flow, (2) a bedside point-of-care assay (platelet function analyzer-closure time adenine DI-phosphate [PFA-CADP]), reflecting HMW multimers changes, could be used to monitor in real-time percutaneous aortic valve procedures. Objective: To investigate the time course of HMW multimers changes in models and patients with instantaneous induction/reversal of pathological high shear and its related bedside assessment. Methods and Results: We investigated the time course of the induction/recovery of HMW multimers defects under instantaneous changes in shear stress in an aortic stenosis rabbit model and in patients undergoing implantation of a continuous flow left ventricular assist device. We further investigated the recovery of HMW multimers and monitored these changes with PFA-CADP in aortic stenosis patients undergoing transcatheter aortic valve implantation or balloon valvuloplasty. Experiments in the aortic stenosis rabbit model and in left ventricular assist device patients demonstrated that induction/recovery of HMW multimers occurs within 5 minutes. Transcatheter aortic valve implantation patients experienced an acute decrease in shear stress and a recovery of HMW multimers within minutes of implantation which was sustained overtime. In patients with residual high shear or with residual aortic regurgitation, no recovery of HMW multimers was observed. PFA-CADP profiles mimicked HMW multimers recovery both in transcatheter aortic valve implantation patients without aortic regurgitation (correction) and transcatheter aortic valve implantation patients with aortic regurgitation or balloon valvuloplasty patients (no correction). Conclusions: These results demonstrate that variations in von Willebrand factor multimeric pattern are highly dynamic, occurring within minutes after changes in blood flow. It also demonstrates that PFA-CADP can evaluate in real time the results of transcatheter aortic valve procedures.