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. (C) 2013 by The Society of Thoracic Surgeons