Balloon-Expandable Versus Self-Expanding Transcatheter Aortic Valve Replacement

Abstract

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.

Mid-term outcomes of Sapien 3 versus Perimount Magna Ease for treatment of severe aortic stenosis

“…A low incidence (1.9%) of moderate paravalvular regurgitation with Sapien 3 in our study was in concordance with other studies, and potentially impacted the outcomes [25]. Secondly, including different generations of balloon-expandable and self-expanding TAVR prostheses in previous observational studies may have introduced a significant bias [16].…”

“…However, a higher rate of structural valve deterioration leading to hemodynamic compromise was observed with the second-generation Sapien XT valve compared to the third-generation Sapien 3 valve prosthesis and the surgical valves in the PARTNER 2 trial [14]. Importantly, TAVR with different valve types and their iterations may result in discrepant outcomes and valve performance [14][15][16]. Therefore it is important to compare the outcomes of each TAVR prosthesis separately against SAVR prostheses with proven long-term durability [17,18].…”

Conduction disturbances following trancatheter aortic valve implantation: increasing the ‘pace’ towards prospective evidence

“…In particular, the exact role of electrophysiological studies, patch ECG recorders, and implantable loop recorders in the management of new-onset LBBB or transient high-degree atrioventricular block should be delineated (Take-home Figure). Moreover, some recent studies questioned the class effect of TAVI, suggesting that not all transcatheter heart valve's designs are equal, especially regarding conduction disturbances 13,14 . Collectively, these observational data, along with the meta-analysis by Faroux et al 12 , should ultimately spur adequately-powered randomized comparisons of the commercially-available valves most commonly implanted in routine practice.…”

Next-generation transcatheter aortic valve implantation

“…[11][12][13] Current commercialized TAVI also causes serious complications, which include paravalvular leakage, aortic regurgitation, aortic stenosis, complete atrioventricular block requiring permanent pacemaker implantation, stent migration, coronary obstruction, and myocardial infarction. 2,3 The complication of new-onset atrioventricular and intraventricular conduction block is most common, 1,14 and the complication of prosthesis dislocation is the most important. 1,15 Alternative strategies are needed to avoid such complications.…”

“…1,15 Alternative strategies are needed to avoid such complications. [1][2][3]14,15 To solve current issues related to periprocedural safety, a stented valve for TAVI should be customized by 3-dimensional (3D) printing technology. 16 In this study, we proved the first preclinical safety and efficacy for next-generation TAVI.…”