Benefit of transcatheter aortic valve implantation (TAVI) with the CoreValve Revalving system (Medtronic) is maintained up to one year, with “acceptable mortality rates” at various time points, based on results of an Italian muliticenter registry that were published online Jan. 10 in Circulation. Also, the study authors were able to establish unique mortality predictors, which vary at 30 days and one year.
According to Corrado Tamburino, MD, PhD, from Ferrarotto Hospital in Catania, Italy, and his colleagues, there is a lack of information on the incidence and predictors of early mortality at 30 days and late mortality between 30 days and one year after TAVI with the self-expanding CoreValve Revalving prosthesis.
In the registry, a total of 663 consecutive patients (mean age 81) underwent TAVI with the third-generation 18F CoreValve device in 14 centers.
The researchers reported that the procedural success and intraprocedural mortality were 98 percent and 0.9 percent, respectively. The cumulative incidences of mortality were 5.4 percent at 30 days, 12.3 percent at six months, and 15 percent at one year. The incidence density of mortality was 12.3 per 100 person-year of observation.
They observed that one-third of deaths were within the first 30 days after the procedure and almost 25 percent occurred within the first two weeks, “frequently as the effect of procedure-related issues; the incidence of mortality after 30 days did not stop, but continued at a steady state of 0.9 percent per month during the first year, driven primarily by comorbidities unrelated to aortic valve disease.”
Clinical and hemodynamic benefits observed acutely after TAVI were sustained at one year, the authors reported. Paravalvular leakages were trace to mild in the majority of cases.
Tamburino and colleagues reported that 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 percent (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 one year.
“Although procedural complications are strongly associated with early mortality at 30 days, comorbidities and post-procedural paravalvular aortic regurgitation >2+ mainly impact late outcomes between 30 days and one year,” the authors concluded.
“This study highlights the fact that different causes may be called into question when analyzing the incidence of mortality within a short or late timeframe following the percutaneous procedure,” they added.