Early and Midterm Outcomes of Transcatheter Aortic-Valve Replacement with Balloon-Expandable Versus Self-Expanding Valves: A Systematic Review and Meta-Analysis

Background The comparative performances of transcatheter aortic-valve replacement (TAVR) with balloon-expandable valves (BEV) and self-expanding valves (SEV) in severe aortic stenosis remain unclear. Purpose To compare the early (30-day) and midterm (1-year) mortality and cardiovascular outcomes of BEV with SEV. Data Sources PubMed, EMBASE, and the Cochrane Library from inception until February 13, 2020. Study Selection 3 randomized controlled trials (RCTs) and 12 propensity-score matched (PSM) studies, with 37,958 patients. Data Extraction 2 reviewers independently extracted study data and rated study quality. Data Synthesis: Compared with SEV, BEV was associated with significantly lower mortality at 30 days (OR 0.77, 95% CI 0.71–0.83, P< 0.00001, I 2 =0) and a trend toward lower mortality at 1 year (OR 0.88, 95% CI 0.78–1.00, P= 0.05, I 2 =15.8%), mainly driven from PSM studies, but regardless of valve generations and SEV types. 30-day and 1-year cardiovascular mortality, 30-day incidences of moderate to severe paravavular leak, procedural contrast agent volume and procedure time were lower, but transvalvular pressure gradient was higher in BEV than SEV. 30-day incidences of permanent pacemaker implantation (PPI), acute kidney injury, stroke, major bleeding, major vascular complications and rehospitalization were not statistically different between BEV and SEV. Early-generation SEV was associated with a higher 30-day PPI risk than corresponding BEV comparators. PPI risk was lower in ACURATE neo but higher in Evolut R SEV, both compared with SAPIEN 3 BEV. Limitations Study-level but not patient-level data; residual confounders in PSM studies; study designs and patient characteristics were heterogeneous. Conclusions Compared with SEV, BEV might be associated with lower early and midterm mortality. Results from adequately powered RCTs with long-term follow-up are critically needed to confirm these findings. Registration PROSPERO (CRD42020172889). Funding Source National Natural Science Foundation of China (NO. 81600312). ### Competing Interest Statement The authors have declared no competing interest. ### Clinical Trial PROSPERO (CRD42020172889) ### Funding Statement National Natural Science Foundation of China (NO. 81600312). ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: The ethics committee of Nanjing Drum Tower hospital provided exemption of our study. All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable. Yes All data were presented in the main manuscript or supplementary materials.