Is the redesigned Edwards Sapien XT THV linked to a more frequent occur of perivalvular Leckage in comparison to the predecessor model?

Objective: In 2011 the Edwards Sapien transcatheter heart valve (ES-THV) was redesigned in order to reduce the diameter of the implantation tool. The modification of the stent design as well as the new stent material made the new valve more competitive for endovascular implantation.

Aim of this study was to evaluate differences in periprosthetic aortic reurgitation (pAR) in patients which had undergone transapical aortic valve implantation with either an ESV-THV Model 9000 TFX (ES-THV) or the redesigned Edwards Sapien XT transcatheter heart valve Model 9300 TFX (ES-XT-THV).

Methods: As from June 2010 we included all patients which had undergone transapical TAVI with correct positioning of the valve in first attempt. 2 patients were excluded due to dislocation of the valve – one in each group. All implantations were performed by the same team and same technique. The annulus size was determined using peroperative TEE, supported by contrast enhanced CT-Scans. Valve sizes were chosen according to industry guidelines.

The severity of the pAR was evaluated by an experienced examiner immediately after implantation and before the patients discharge using TEE and TTE. The pAR was graded into the following groups: no pAR, mild pAR (grade I, trace) and relevant pAR (≥ grade II).

Results: We analyzed 52 patients which had undergone transapical TAVI using either an ES-THV (n = 26) or an ES- XT-THV (n = 26). Mean age was 80 ± 9 years (9 male) and 77 ± 7 years (13 male) in the ES-THV and ES-XT-THV group respectively.

Mean annulus size was 21 ± 2 mm and 23 ± 3 mm in the ES-THV and ES-XT-THV group respectively. We saw a significantly higher portion of overall pAR in the ES-XT-THV group (n (ES-THV)= 8 vs. n (XT-THV)= 15, p = 0.0261) but no significant higher rate of clinically relevant pAR (n (ES-THV)= 0, n (XT-THV)= 2, p = 0.0539) using the chi-square test. In the ES-THV group, no patients died within 30 days or within the hospital stay, in the ES-XT-THV group 3 (11.5%) patients died within this time.

Conclusion: Our data suggest that the ES-XT-THV causes a higher rate of pAR than its predecessor model ES-THV. There is no significance for a clinical relevance of this finding. Nevertheless, should larger series support our findings, the “old” ES-THV model could be brought back to market and offered for transapical implantation. Our paper discusses the localization and the possible reasons for these “new” perivalvular leackages.