Transcatheter Aortic Valve Replacement in Low Surgical Risk Patients: An Updated Metanalysis of Extended Follow-Up Randomized Controlled Trials

Gianluca Di Pietro; Riccardo Improta; Ovidio De Filippo; Francesco Bruno; Lucia Ilaria Birtolo; Marco Tocci; Tommaso Fabris; Wael Saade; Riccardo Colantonio; Paola Celli; Gennaro Sardella; Giovanni Esposito; Giuseppe Tarantini; Mancone Massimo; Fabrizio D'Ascenzo

doi:10.1016/j.amjcard.2024.05.005

Transcatheter Aortic Valve Replacement in Low Surgical Risk Patients: An Updated Metanalysis of Extended Follow-Up Randomized Controlled Trials

Am J Cardiol. 2024 May 8:S0002-9149(24)00358-8. doi: 10.1016/j.amjcard.2024.05.005. Online ahead of print.

Authors

Affiliations

¹ Department of Clinical, Internal, Anesthesiology and Cardiovascular Sciences, Umberto I Hospital, Sapienza University of Rome, Italy; Department of Medical Science, Division of Cardiology, Molinette Hospital, Turin University, Italy.
² Department of Medical Science, Division of Cardiology, Molinette Hospital, Turin University, Italy.
³ Department of Clinical, Internal, Anesthesiology and Cardiovascular Sciences, Umberto I Hospital, Sapienza University of Rome, Italy.
⁴ Department of Cardiac, Thoracic and Vascular Sciences and Public Health, University of Padova, Italy.
⁵ Department of General and Specialistic Surgery "Paride Stefanini", "Sapienza" University of Rome, Rome, Italy.
⁶ Division of Cardiology, Department of Advanced Biomedical Sciences, Federico II University of Naples, Naples, Italy.
⁷ Department of Clinical, Internal, Anesthesiology and Cardiovascular Sciences, Umberto I Hospital, Sapienza University of Rome, Italy. Electronic address: massimo.mancone@uniroma1.it.

PMID: 38729335
DOI: 10.1016/j.amjcard.2024.05.005

Abstract

The long-term safety and effectiveness of transcatheter aortic valve replacement (TAVR) compared with surgical aortic valve replacement (SAVR) in low surgical risk has not been evaluated in a pooled analysis. An electronic database search was conducted for randomized controlled trials with a maximal 5 years clinical and echocardiographic follow-up including low surgical risk patients who underwent TAVR or SAVR. We calculated odds ratio (OR) and 95% confidence intervals (CIs) using a random-effects model. Subgroups analysis was performed for permanent pacemaker implantation and paravalvular leaks. Three randomized controlled trials were included with a total of 2,611 low surgical risk patients (Society of Thoracic Surgeons score <4%). Compared with SAVR, the TAVR group had similar rates of all-cause mortality (OR 0.94,95% CI 0.65 to 1.37, p = 0.75) and disabling stroke (OR 0.84, 95% CI 0.52 to 1.36, p = 0.48). No significant differences were registered in the TAVR group in terms of major cardiovascular events (OR 0.96, 95% CI 0.67 to 1.38, p = 0.83), myocardial infarction (OR 0.69, 95% CI 0.34 to 1.40, p = 0.31), valve thrombosis (OR 3.11, 95% CI 0.29 to 33.47, p = 0.35), endocarditis (OR 0.71,95% CI 0.35 to 1.48, p = 0.36), aortic valve reintervention (OR 0.93, 95% CI 0.52 to 1.66, p = 0.80), and rehospitalization (OR 0.80, 95% CI 0.52 to 1.02, p = 0.07) compared with SAVR. However, TAVR patients had a higher risk of paravalvular leaks (OR 8.21, 95% CI 4.18 to 16.14, p <0.00001), but lower rates of new-onset atrial fibrillation (OR 0.27,95% CI 0.17 to 0.30, p <0.0001). The rates of permanent pacemaker implantation were comparable from 1 year up to a maximum of 5 years (OR 1.32, 95% CI 0.88 to 1.97, p = 0.18). Lastly, TAVR had a greater effective orifice area (0.10 cm²/m², 95% CI 0.05 to 0.15, p = 0.0001), but similar transvalvular mean gradients (0.60, 95% CI 3.94 to 2.73, p = 0.72). In conclusion, TAVR patients had similar long-term outcomes compared with SAVR, except for an elevated risk of paravalvular leaks in the TAVR group and increased rates of atrial fibrillation in the SAVR cohort.

Keywords: Long-term; Low surgical risk; Metanalysis; Outcomes; SAVR; TAVR.