Clinical and hemodynamic outcomes of "all-comers" undergoing transapical aortic valve implantation: results from the Italian Registry of Trans-Apical Aortic Valve Implantation (I-TA).

OBJECTIVE: The aim of this study was to assess clinical and hemodynamic outcomes of transapical aortic valve implantation (TA-TAVI) in patients enrolled in the Italian Registry of Trans-Apical Aortic Valve Implantation (I-TA). METHODS: From April 2008 until November 2010, 504 patients from 20 Italian centers were enrolled in the I-TA registry. Mean logistic EuroSCORE and Society of Thoracic Surgeons score were 24% ± 16% and 11% ± 4%, respectively. Mean follow-up was 9.2 ± 6.5 months (range, 1-26 months). Outcomes were analyzed according to intraoperative complications, procedural volume (high-volume centers, >20 cases; low-volume centers, < 20 cases) and learning curve (first 50% cases vs second 50% cases of each center). RESULTS: All-cause overall mortality was 8.3% (42 patients). Device success was 99% (500/504 patients). Intraoperative severe complications occurred in 24 (4.8%) patients. Overall 2-year survival was 71.5% ± 6.2%. At discharge, peak and mean gradients were 16.4 ± 11.2 and 8.7 ± 4.1 mm Hg, respectively, and effective orifice area was 1.67 cm(2). These values remained stable at 3, 6, and 12 months after surgery. Independent risk factors for mortality after TA-TAVI were as follows: New York Heart Association class III and IV (odds ratio [OR], 4.43; 95% confidence intervals [CI], 1.28-15.40; P = .02); logistic EuroSCORE greater than 20 (OR, 1.83; 95% CI, 1.02-3.29; P = .04); creatinine concentration greater than 200 µmol/L (OR, 2.56; 95% CI, 1.07-6.15; P = .03), and intraoperative complications (OR, 5.80; 95% CI, 2.68-12.55; P < .001). There were no significant differences in outcomes between high- and low-volume centers and between the first and the second 50% of cases. CONCLUSIONS: TA-TAVI represents a safe and effective alternative treatment for patients who are inoperable or at high risk for surgery. The occurrence of an intraoperative complication significantly affects survival. Procedural volume and learning curve have no impact on patient survival.

Mitral valve repair: is there still a place for suture annuloplasty?

Prosthetic ring annuloplasty is considered the gold standard technique for mitral valve repair, but it has been associated with some drawbacks. Suture annuloplasty is less expensive and may have some physiopathologic advantages. We reviewed the literature to assess clinical results of mitral suture annuloplasty. Thirteen series, each reporting more than 50 patients and published in the last 10 years, were included in the analysis. They comprised 1,648 patients with cumulative follow-up of 5,607 patient-years. Our review suggests that suture annuloplasty is a safe procedure, but a trend toward recurrence of annular dilatation with time was reported. In selected cases, suture annuloplasty is effective, and its mid-term clinical results are encouraging and compare well with those of prosthetic ring repair series. The quality of the results varies according to the particular annuloplasty technique used and to the mitral valve pathology treated. Recent technical modifications have been found to decrease the incidence of repair failure and promise to improve the reproducibility of the procedure. Further investigations are warranted to better assess the long-term results of suture annuloplasty, and to determine whether its theoretical functional advantages translate into a real clinical benefit.