Procedural success and 30-day clinical outcomes after percutaneous aortic valve replacement using current third-generation self-expanding CoreValve prosthesis.

Background: Percutaneous aortic valve replacement (PAVR) is an emerging alternative for high-risk patients with severe aortic stenosis. The aim of this study was to report acute and short-term outcomes of PAVR with the 18 Fr CoreValve Revalving System.
Methods: From January 2007 to July 2008, 69 high-risk symptomatic patients with severe aortic stenosis were screened to assess their eligibility criteria for PAVR. All candidates were evaluated by a cardiac surgeon and a cardiologist. Thirty patients (13 men, 17 women, ages 82 +/- 5 years, range 73-88 years) met all the eligibility criteria and were enrolled in the study.
Results: Twenty-nine patients (97%) underwent successful valve implantation by a retrograde approach, with improvement in valve area (0.61 +/- 0.18 cm(2) to 1.49 +/- 0.39 cm(2); p < 0.001) and transvalvular gradient (58.1 +/- 17.6 mmHg to 9.2 +/- 4.0; p < 0.001). Paravalvular leakages were 1+ (n = 12) and 2+ (n = 2). Procedural success was achieved in 93% of patients, with 1 case of pericardial tamponade occurred during the first 48 hours after implantation. At 30-day mortality was 7%. The mean NYHA Functional Class declined from 2.72 +/- 0.59 to 1.31 +/- 0.47 (p < 0.001). No other major adverse events occurred at a mean follow up of 4.9 +/- 4.0 months (range 1-13 months).
Conclusions: Our initial experience of PAVR in a cohort of older and high-risk surgical patients has been positive, with excellent acute and encouraging short-term results in terms of safety and efficacy.