Permanent pacemaker implantation and paravalvular leak rates following sutureless aortic valve operations

Abstract

Background: Permanent pacemaker (PPM) implantation and paravalvular leak (PVL) rates after sutureless aortic valve replacement (SuAVR) vary widely. The aim of this meta-analysis was to examine the incidence of new PPM implantation and PVL after SuAVR.

Methods: Studies evaluating PPM implantation and PVL rates after SuAVR were searched in Medline/PubMed, Ovid Journals, Clinicaltrials.gov, Cochrane central register of controlled trials and database. Studies with a sample size ≥10 were included in this analysis. Pooled proportions were calculated using both the fixed and random-effects models. The heterogeneity among studies was tested using I² statistic. The study design was written in accordance with PRISMA guidelines.

Results: Thirty studies involving 3993 patients with a median follow-up of 12 months were included. The median age was 77 years and males constituted 50%. There was a history of stroke and coronary artery disease in 6% and 31% of the population. Pooled proportions demonstrate a cumulative postoperative PPM rate of 8.5% (95% confidence interval [CI] 7.6-9.5%, I² = 68.8%) and the overall rate of any PVL was 4.2% (95%CI 3.4-5%, I² = 76.1%) across all major SuAVR devices. The rate of severe PVL was only 0.4% (95%CI 0.2-0.7%, I² = 0%) at discharge and 0.5% (95%CI 0.2-0.9%, I² = 0%) at 12 months.

Conclusions: In SuAVR prostheses implanted in this meta-analysis, the postoperative permanent pacemaker rate was higher (8.5%) than reported for non-SuAVR prosthesis. While the overall PVL rate was 4.2%, the incidence of severe PVL was only 0.4% at discharge and remained stable at 0.5% at 12 months.

Keywords: paravalvular leak; permanent pacemaker; rapid deployment aortic valve; sutureless aortic valve.