Thirty-day incidence of stroke after transfemoral transcatheter aortic valve implantation: meta-analysis and mixt-treatment comparison of self-expandable versus balloon-expandable valve prostheses

Abstract Aims Stroke is a major complication after transcatheter aortic valve implantation (TAVI). Although multifactorial, it remains unknown whether the valve deployment system itself has an impact on the incidence of early stroke. We performed a meta- and network analysis to investigate the 30-day stroke incidence of self-expandable (SEV) and balloon-expandable (BEV) valves after transfemoral TAVI. Methods and results Overall, 2723 articles were searched directly comparing the performance of SEV and BEV after transfemoral TAVI, from which 9 were included (3086 patients). Random effects models were used for meta- and network meta-analysis based on a frequentist framework. Thirty-day incidence of stroke was 1.8% in SEV and 3.1% in BEV (risk ratio of 0.62, 95% confidence interval (CI) 0.49–0.80, p = 0.004). Treatment ranking based on network analysis (P-score) revealed CoreValve with the best performance for 30-day stroke incidence (75.2%), whereas SAPIEN had the worst (19.0%). However, network analysis showed no inferiority of SAPIEN compared with CoreValve (odds ratio 2.24, 95% CI 0.70–7.2). Conclusion Our analysis indicates higher 30-day stroke incidence after transfemoral TAVI with BEV compared to SEV. We could not find evidence for superiority of a specific valve system. More randomized controlled trials with head-to-head comparison of SEV and BEV are needed to address this open question. Graphic abstract

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Thirty-day incidence of stroke after transcatheter aortic valve implantation: a meta- and network meta-analysis comparing self-expandable versus balloon-expandable valve prostheses

European Heart Journal ◽

10.1093/ehjci/ehaa946.2593 ◽

2020 ◽

Vol 41 (Supplement_2) ◽

Author(s):

P.C Seppelt ◽

S Mas-Peiro ◽

R De Rosa ◽

I Murray ◽

S Fichtlscherer ◽

...

Keyword(s):

Aortic Valve ◽

Random Effects ◽

Transcatheter Aortic Valve Implantation ◽

Meta Analysis ◽

Stroke Incidence ◽

Randomized Controlled ◽

Transcatheter Aortic Valve ◽

Aortic Valve Implantation ◽

Sapien 3 ◽

Valve Implantation

Abstract Introduction Stroke is a major and feared complication after transcatheter aortic valve implantation (TAVI). So far it is unknown, weather the valve deployment system itself has an impact on the incidence of periinterventional stroke. We sought to identify the incidence of 30-day stroke after transfemoral TAVI with self-expandable (SE) and balloon-expandable (BE) valves and performed a meta- and network meta-analysis to analyze differences related to the valve deployment system. Methods Overall 2706 articles were searched comparing directly the performance of SE and BE TAVI valves, from which 7 were included for analysis (one randomized controlled trial, 6 propensity score matching studies) with a total number of 2488 patients. Meta-analysis used random effects model and reported risk ratios (RRs). To compare different type of valves a random-effects network meta-analysis based on a frequentist framework for indirect and mixed comparisons was applied and reported odds rations (ORs). Using P-Score the relative ranking probability of each valve was estimated and the hierarchy of competing valves was obtained. Results Thirty-day incidence of stroke was 1.9% in SE (22 out of 1139, Medtronic CoreValve, Medtronic Evolut R and Pro, Boston Scientific ACURATE neo and St. Jude Medical Portico) and 3.1% in BE TAVI valves (42 out of 1349, Edwards Sapien 3 and XT) resulting in a RR of 0.65, (95% confidence interval (CI) 0.51 to 0.82). In accordance with the estimated P-Score CoreValve was the best effective for a reduction of 30-day stroke (72,5%) whereas the worst were Sapien 3 and XT (19.%). Combined direct and indirect evidence showed no superiority of CoreValve compared with Sapien valves (OR 0.469, 95% CI 0.13–1.64) concerning 30-day stroke incidence. Conclusion Our meta-analysis indicates a higher thirty-day incidence of stroke after TAVI with BE valves compared to SE valves. Furthermore, we could not find evidence for superiority of a specific valve system. Randomized controlled trials with head to head comparison of SE and BE valves are needed to address this open question. Funding Acknowledgement Type of funding source: None

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