Transapical Transcatheter Aortic Valve Implantation in Pure Aortic Regurgitation: Midterm Outcomes

Objectives: Recently, we evaluated the self-expandable ACURATE-TA device (Symetis S.A., Ecublens, Switzerland) in patients with pure aortic regurgitation. As current experience with transcatheter aortic valve implantation (TAVI) in this specific entity is limited, we aimed to analyze the fate of the aortic annulus as well as the implanted self-expandable prosthesis in the mid-term.

Methods: Between 04/2012 and 09/2014, a total of 10 high-risk patients with pure, severe aortic regurgitation were enrolled (grade III + ). Clinical and hemodynamic data and most importantly, CT-data were collected at 3-years follow-up. Post-interventional non-contrast CT scans were performed using a 2 × 192 slice CT scanner (Somatom Definition Force; Siemens Healthcare, Germany; 70 kV; collimation, 0.6mm; reconstructed slice thickness, 0.75mm). CT data analysis was performed by using dedicated, commercially available software that enables post processing of cardiac CT data (Syngo Via, Siemens Healthcare, Germany).

Results: Patients mean age was 72.3 ± 7.9 years (mean ± SD) and 40% were female. Mean logistic EuroSCORE I was 31.9 ± 8.7%. Three patients had undergone emergency aortic operation before due to acute type-A aortic dissection, whereas the other patients suffered from primary aortic regurgitation. All patients underwent successful transapical TAVI with the transapical ACURATE TA device (size S, n = 1, size M, n = 4 and size L, n = 5) without any intra-procedural complications according to the VARC-2 criteria. At 30-days, stroke incidence and all-cause mortality were 0%. At 3-years follow-up, all, but one patient were alive and in NYHA functional class I or II. Mean pressure gradients were 8.1 ± 2.1mmHg and one patient showed mild paravalvular leakage. One patient required pacemaker implantation. Post-interventional CT-scan revealed a slightly increased aortic annulus diameter (compared with pre-intervention) after implantation of the self-expandable bioprosthesis with no migration of the prosthesis, or any fractures of the Nitinol stent frame itself.

Conclusion: The present small single-center observational study proves a stable situation of the aortic annulus in patients with pure aortic regurgitation treated with the self-expandable ACURATE-TA device with no migration of the prosthesis at 3-years follow-up.