Permanent pacemaker implantation following transcatheter aortic valve implantation: a systematic review and Bayesian network meta-analysis

Abstract

Abstract Funding Acknowledgements Type of funding sources: None. Introduction Permanent pacemaker implantation (PPI) remains a common complication after transcatheter aortic valve implantation (TAVI). Different transcatheter heart valves (THVs) exist, and newly approved devices are growing. A comparison according to the mechanisms of TAVI prosthesis with longer follow-up needs to be made. We address this issue using a systematic review and a Bayesian network meta-analysis (NMA). Methods A systematic literature review was carried out up to Oct 31, 2022, to identify studies reporting the use of balloon-expandable valves (BEVs), self-expandable valves (SEVs), and mechanically expandable valves (MEVs). We compared the various THVs, or standard medical treatment (STD), with a common comparator of surgical aortic valve replacement (SAVR) concerning PPI. Data at the most extended follow-up for each study were extracted. A random-effects Bayesian NMA was used to calculate odds ratios (OR) and 95% credible intervals (CrI) using MetInsight V4.0.0. The surface under the cumulative ranking area (SUCRA) probabilities was selected to calculate the ranking and hierarchy of the different treatments. The larger SUCRA indicates the greater likelihood of becoming the best intervention. Results We included 15 RCTs comprising 12.783 patients, among whom 8.585 underwent TAVI using various commercially available THVs, including BEVs (Sapien & Sapien XT, Sapien 3), MEVs (Corevalve, Evolut & Pro/R, Acurate Neo, Portico), and MEVs (Lotus). The median follow-up was 2.5 years (IQR 1-5). No significant differences in the risk of PPI were observed between STD: 1.70 [0.556, 5.39], Sapien & Sapien XT: 1.39 [0.834, 2.41], Sapien 3: 1.70 [0.977, 2.88], and Acurate Neo: 1.68 [0.768, 3.789], compared with SARV. All the other THVs (Corevalve: 3.07 [1.99. 4.959]; Evolut & Pro/R: 3.19 [1.80, 6.03]; Lotus: 5.22 [2.08, 13.7]; Portico: 7.22 [2.85, 19.4]) showed significant differences in the risk of PPI compared with SARV. In Bayesian ranking results, Sapien & Sapien XT had the highest chance (77%) of providing a lower PPI rate. Meanwhile, Portico THV was ranked the worst (5%) regarding the likelihood of PPI rate (Figure 1). According to the mechanism, all the THVs showed a higher risk for PPI than SARV (BEVs: 1.60 [1.01, 2.54]; SEVs: 3.09 [1.97, 4.96]; and MEV: 5.30 [1.62, 17.7]). STD: 1.92 [0.518, 7.14] had a non-significant PPI rate compared with SARV. SUCRA plot showed that SARV was the intervention with the lowest (95%) probability of PPI, followed by BEVs (65%), STD (55%), SEVs (27%) and MEVs (7%) (Figure 2). In both analyses, the assessment of inconsistency between direct and indirect estimates was not significant (P > 0.05). Conclusions This NMA of RCTs includes a more significant number of patients with longer follow-up. We demonstrated that BEVs are associated with lower PPI rates than SEVs and MEVs. Some newer generations of THVs (Acurate Neo, Evolut R/Pro) performed better than the older ones, reducing the PPI rate.