Incidence and Predictors of Early and Late Mortality After Transcatheter Aortic Valve Implantation in 663 Patients With Severe Aortic Stenosis

TLDR

There is limited data on early (30‑day) and late (30‑day to 1‑year) mortality rates and their predictors following transcatheter aortic valve implantation with the CoreValve Revalving system. The study enrolled 663 consecutive patients (mean age 81 ± 7.3 years) who underwent third‑generation 18‑Fr CoreValve TAVI across 14 centers. Procedural success was 98 % with 0.9 % intraprocedural mortality; cumulative mortality reached 5.4 % at 30 days, 12.2 % at 6 months, and 15.0 % at 1 year, with early death driven by conversion to surgery, tamponade, access complications, low LVEF, prior balloon valvuloplasty, and diabetes, and late death driven by prior stroke, ≥2+ paravalvular leak, prior pulmonary edema, and chronic kidney disease, yet clinical benefits and low leak rates were sustained over 1 year.

Abstract

Background— There is a lack of information on the incidence and predictors of early mortality at 30 days and late mortality between 30 days and 1 year after transcatheter aortic valve implantation (TAVI) with the self-expanding CoreValve Revalving prosthesis. Methods and Results— A total of 663 consecutive patients (mean age 81.0±7.3 years) underwent TAVI with the third generation 18-Fr CoreValve device in 14 centers. Procedural success and intraprocedural mortality were 98% and 0.9%, respectively. The cumulative incidences of mortality were 5.4% at 30 days, 12.2% at 6 months, and 15.0% at 1 year. The incidence density of mortality was 12.3 per 100 person-year of observation. Clinical and hemodynamic benefits observed acutely after TAVI were sustained at 1 year. Paravalvular leakages were trace to mild in the majority of cases. Conversion to open heart surgery (odds ratio [OR] 38.68), cardiac tamponade (OR 10.97), major access site complications (OR 8.47), left ventricular ejection fraction <40% (OR 3.51), prior balloon valvuloplasty (OR 2.87), and diabetes mellitus (OR 2.66) were independent predictors of mortality at 30 days, whereas prior stroke (hazard ratio [HR] 5.47), postprocedural paravalvular leak ≥2+ (HR 3.79), prior acute pulmonary edema (HR 2.70), and chronic kidney disease (HR 2.53) were independent predictors of mortality between 30 days and 1 year. Conclusions— Benefit of TAVI with the CoreValve Revalving System is maintained over time up to 1 year, with acceptable mortality rates at various time points. Although procedural complications are strongly associated with early mortality at 30 days, comorbidities and postprocedural paravalvular aortic regurgitation ≥2+ mainly impact late outcomes between 30 days and 1 year.