Medium term outcomes of transapical aortic valve implantation: Results from the Italian registry of trans-apical aortic valve implantation

Background: Transcatheter aortic valve implantation (TAVI) has been proposed as a therapeutic option for high-risk or inoperable patients with severe symptomatic aortic valve stenosis. The aim of this multicenter study was to assess early and medium term outcomes of transapical aortic valve implantation (TA-TAVI). Methods: From April 2008 through June 2012, a total of 774 patients were enrolled in the Italian Registry of Trans-Apical Aortic Valve Implantation (I-TA). Twenty-one centers were included in the I-TA registry. Outcomes were also analyzed according to the impact of the learning curve (first 50% cases versus second 50% cases of each center) and of the procedural volume (high-volume versus low-volume centers). Results: Mean age was 81.0 ± 6.7 years, mean logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) I, EuroSCORE II, and The Society of Thoracic Surgeons risk score were 25.6% ± 16.3%, 9.4% ± 11.0%, and 10.6% ± 8.5%, respectively. Median follow-up was 12 months (range, 1 to 44). Thirty-day mortality was 9.9% (77 patients). Overall 1-, 2-, and 3-year survival was 81.7% ± 1.5%, 76.1% ± 1.9%, and 67.6% ± 3.2%, respectively. Thirty-day mortality of the first 50% patients of each center was higher when compared with the second half (p = 0.04) but 3-year survival was not different (p = 0.64). Conversely, 30-day mortality at low-volume centers versus high-volume centers was similar (p = 0.22). At discharge, peak and mean transprosthetic gradients were 21.0 ± 10.3 mm Hg and 10.2 ± 4.1 mm Hg, respectively. These values remained stable 12 and 24 months after surgery. Conclusions: Transapical TAVI provides good results in terms of early and midterm clinical and hemodynamic outcomes. Thus it appears to be a safe and effective alternative treatment for patients who are inoperable or have high surgical risk.