Mortality After TAVI in Patients With Severe Aortic Stenosis Studied

January 18, 2011—According to Corrado Tamburino, MD, et al, 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 (Medtronic, Inc., Minneapolis, MN). To address this need, the investigators conducted a study of the incidence and predictors of early and late mortality after TAVI. The findings were published in Circulation (2011;123:299–308).

The investigators reported that 663 consecutive patients (mean age, 81 ± 7.3 years) at 14 centers underwent TAVI with the third-generation 18-F CoreValve device. Procedural success and intraprocedural mortality rates were 98% and 0.9%, respectively. The cumulative incidences of mortality were 5.4% at 30 days, 12.2% at 6 months, and 15% at 1 year. The incidence density of mortality was 12.3 per 100 person-years of observation. Clinical and hemodynamic benefits observed acutely after TAVI were sustained at 1 year.

The investigators found that 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), previous balloon valvuloplasty (OR, 2.87), and diabetes mellitus (OR, 2.66) were independent predictors of mortality at 30 days, whereas previous stroke (hazard ratio [HR], 5.47), postprocedural paravalvular leak ≥ 2+ (HR, 3.79), previous acute pulmonary edema (HR, 2.7), and chronic kidney disease (HR, 2.53) were independent predictors of mortality between 30 days and 1 year.

The investigators concluded that the 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 affect late outcomes between 30 days and 1 year.