Meta-analysis of complications in aortic valve replacement: comparison of Medtronic-Corevalve, Edwards-Sapien and surgical aortic valve replacement in 8,536 patients.

BACKGROUND: We sought to establish the complication rates following transcatheter aortic valve replacement (TAVR) in the context of high risk and octogenarian surgical aortic valve replacement (SAVR) in the contemporary literature, and to critically analyze population characteristics and outcomes.

METHODS: TAVR studies were selected from nonoverlapping series and SAVR studies for comparison if they met similar entry criteria. Bayesian meta-analytic methods were employed.

RESULTS: For the 5024 TAVR and 3512 SAVR patients included in the study, TAVR subjects had greater baseline renal impairment (P < 0.001), a higher incidence of prior myocardial infarction (P = 0.032) and respiratory disease (P = 0.005) and a higher logistic EuroSCORE (P = 0.039). There were no significant differences observed in complications studied in SAVR and TAVR: 30 day mortality (9% vs 8.5%, P = 0.31), 1 year mortality (18.4% vs 22.8%, P = 0.65), 30 day stroke (2.4% vs 2.6%, P = 0.72), new permanent pacemaker (5.9% vs 12.1%, P = 0.055) and dialysis inception (2.4% vs 4.1%, P = 0.70). We also compared demographics and outcomes between the two types of transcatheter valves. Apart from some variation in functional status, there were no significant differences at baseline with different TAVR designs. The only difference in complications was the need for pacemaker insertion, higher with the Medtronic-Corevalve than with the Edwards-Sapien design (24.5% vs 5.9% P < 0.0001).

CONCLUSIONS: Complications for elderly and high risk aortic stenosis patients being treated by TAVR appear comparable to those selected for SAVR in the real-world.