Response to Letter Regarding Article, “Postprocedural Aortic Regurgitation in Balloon-Expandable and Self-Expandable Transcatheter Aortic Valve Replacement Procedures: Analysis of Predictors and Impact on Long-Term Mortality: Insights From the FRANCE2 Registry”

Abstract

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...

Transcatheter aortic valve implantation with the self‐expandable venus A‐Valve and CoreValve devices: Preliminary Experiences in China

“…The high frequency of valve‐in‐valve procedures might be related to two major factors. First of all, moderate aortic regurgitation was considered unacceptable in our study, as it has been reported to independently predict mid‐term mortality . Therefore, in cases with persistent moderate or severe aortic regurgitation after several attempts of postdilation, we always chose to implant a second valve.…”

Analysis of Long-Term Survival Following Transcatheter Aortic Valve Implantation from a Single High-Volume Center

“…In the French Aortic National CoreValve and Edwards registry, 16 those patients with postprocedural aortic regurgitation !2þ were associated with higher risk for 1-year mortality. It appears that there is no association of mild aortic regurgitation after TAVI with short-term mortality.…”

Impact and Management of Paravalvular Regurgitation After Transcatheter Aortic Valve Replacement

“…In several large registries, moderate or higher PVR but not mild PVR was shown to have a significant impact on survival. 13,14 In the meta-analysis by Athappan and colleagues, 17 mild PVR was associated with a 1.9-fold increase in mortality, but this association was not confirmed in sensitivity analysis. Several factors may explain the intriguing association between mild PVR and mortality including (i) the difficulty of grading PVR and the possibility that it may have been underestimated in a substantial number of patients and (ii) the worse baseline risk profile of patients with mild PVR versus those with none or trace PVR.…”

“…29,30 Several nonrandomized studies have reported a greater incidence of PVR with the self-expanding CoreValve versus the balloon expandable SAPIEN valve. 14,17,33,34 In a recent meta-analysis, the incidence of moderate or severe PVR was 16% with the CoreValve versus 9% for the SAPIEN (P 5 .005). The randomized, controlled trial CHOICE confirmed that moderate/severe PVR is more frequent with the CoreValve compared with the SAPIEN (18.3% vs 4.1%; P<.001).…”