Dedicated Versus Conventional Devices in Patients With Pure Native Aortic Regurgitation: A Systematic Review and Meta-Analysis

Background: Surgical aortic valve replacement is the gold standard for treating pure native aortic regurgitation. However, many patients have unacceptable surgical risk. Increasing evidence supports the use of transcatheter aortic valve replacement in this subset. This metanalysis aims to evaluate transcatheter aortic valve replacement efficacy in pure native aortic regurgitation. Methods: We systematically searched MEDLINE/PubMed, Embase, the Cochrane Database, Google Scholar, ClinicalTrials.gov, and major cardiology conference abstracts from inception to April 1, 2024, and included 19 observational studies with ≥20 patients with pure native aortic regurgitation undergoing transcatheter aortic valve replacement. The primary end point was 30-day all-cause mortality; secondary end points were device success, valve migration, and 1-year all-cause mortality. Pooled estimates were calculated using random-effects meta-analysis. Risk of bias was assessed using the Newcastle-Ottawa Scale and publication bias with funnel plots and Egger's test. The study protocol was registered in International Prospective Register of Systematic Reviews (CRD42024534117). Results: The pooled 30-day mortality was 8.7% (95% CI, 5.8%-10.7%), and decreased from first (16.9% [95% CI, 13.2%-18.9%]) to second generation (7.2% [95% CI, 6.1%-9.2%]) and dedicated devices (4.7% [95% CI, 1.8%-8.9%; P<0.0001]). Overall device success was 84.1% (95% CI, 78.0%-88.9%), improving from first (63.1% [95% CI, 52.0%-72.5%]) to second generation (86.3% [95% CI, 80.1%-90.4%]) and dedicated devices (93.0% [95% CI, 86.2%-97.3%]; P<0.00001). Valve migration occurred in 7.8% (95% CI, 5.0%-11.7%) of cases, decreasing from first (19.0% [95% CI, 15.2%-24.7%]) to second generation (6.9% [95% CI, 3.7%-10.0%]) and dedicated devices (3.0% [95% CI, 1.3%-5.6%]; P<0.00001). Overall 1-year mortality was 14.0% (95% CI, 10.1%-19.9%) and decreased from first (27.2% [95% CI, 15.4%-43.2%]) to second generation (12.7% [95% CI, 8.8%-18.9%]) and dedicated devices (8.7% [95% CI, 3.5%-16.7%]; P<0.0001). Conclusions: Although the observational design, lack of patient-level data, device heterogeneity, and potential publication bias limit definitive conclusions, transcatheter aortic valve replacement using dedicated devices may be considered a safe and effective therapeutic option for patients with pure native aortic regurgitation and unacceptable risk for surgery. Registration: URL: https://www.crd.york.ac.uk/prospero/; Unique identifier: CRD42024534117.