Transapical aortic valve implantation: predictors of leakage and impact on survival: an update.

Background: In line with our institutional strategy, we do not accept paravalvular leakage after transcatheter aortic valve implantation (TAVI). Apart from data from very limited initial experience, predictors of leakage in large cohorts treated with new types of TAVI prostheses are still lacking.

Methods: From April 2008 to August 2013, 730 patients underwent transapical TAVI at our institution. The study group consisted of all 324 patients who received the new generation of balloon-expandable prostheses (SAPIEN XT; Edwards Lifesciences, LLC, Irvine, CA). Based on the Society of Thoracic Surgeons predicted risk of mortality, the arithmetic risk for surgery in the study cohort was 11% ± 9% (1% to 62%) and 20 (6%) patients were in cardiogenic shock.

Results: In study cohort, the overall 30-day mortality rate was 4.0% (3.3% in patients without cardiogenic shock). The postprocedural grade of regurgitation was absent or trace in 269 of 324 patients (83%), mild in 52 of 324 (16%), and moderate in 3 of 324 (< 1%); there was no severe postprocedural regurgitation. Regurgitation occurred less often (p < 0.001) in patients who received the XT-type prosthesis. Patients with more than trace regurgitation presented with less oversizing of the prosthesis in terms of annular area (p < 0.001) and higher calcium scores of the device landing zone (p < 0.001). The presence of calcified plaques in the left ventricular outflow tract was the strongest predictor of leakage (odds ratio 10.23, 95% confidence interval 5.12 to 20.45, p < 0.001). The regurgitation grade was not predictive for follow-up mortality (hazard ratio 1.08, 95% confidence interval 0.61 to 1.90, p = 0.800).

Conclusions: In transapical TAVI, the risk of relevant paravalvular leakage may be eliminated completely. There is no negative impact on survival in patients with lesser, irrelevant grades of regurgitation.