Clinical outcomes after transcatheter aortic valve replacement in South America: A centre‐level systematic review and meta‐analysis of observational data

Abstract

Objectives To estimate in‐hospital and 30‐day outcomes after transcatheter aortic valve replacement (TAVR) in South America through a systematic review and meta‐analysis of observational data. Methods We comprehensively searched for papers published in peer‐reviewed medical journals and for abstracts presented in medical conferences of the region from 1 September 2008, through 29 June 2020, using predefined criteria. We included single‐centre studies on TAVR populations with ≥10 patients from South America reporting any in‐hospital or 30‐day clinical outcome. Results Fifty‐five cohorts from seven countries, pooling 3001 patients, were included in a random‐effects meta‐analysis. Self‐expandable prostheses were the most frequently implanted. Pooled estimate of procedure success by VARC2 criteria was 90.0% (95%CI 81.8%‐94.7%; I2 75.0%). The pooled estimate rates of the outcomes were as follow: post‐procedure moderate or severe aortic regurgitation, 9.7% (95%CI 6.0%‐15.4%; I2 65.4%), in‐hospital cardiac tamponade, 4.0% (95%CI 2.5%‐6.6%; I2 0%), in‐hospital stroke, 4.1% (95%CI 2.9%‐5.7%; I2 0%), in‐hospital major vascular complication, 7.8% (95%CI 5.2%‐11.5%; I2 22.3%), in‐hospital permanent pacemaker implantation, 19.4% (95%CI 15.9%‐23.4%; I2 53.8%), in‐hospital mortality, 8.0% (95%CI 6.7%‐9.6%; I2 0%), and 30‐day mortality, 9.7% (95%CI 7.9%‐11.8%; I2 26.4%). Conclusion As compared with published international registries, the overall results of TAVR in South America seemed underrated. Significant heterogeneity was observed in procedural success, pacemaker requirement, and post‐procedure moderate or severe aortic regurgitation. This study provides a real‐life framework for the analysis of the performance of this technology in the region, intended to be a starting point for quality improvement.

Evaluaciones económicas en salud: ¿qué debemos tener en cuenta al leerlas?

“…11 Finalmente, a la hora de considerar el beneficio clínico de una TS, es importante resaltar que cada país o jurisdicción tiene características propias (población, infraestructura, recursos humanos, accesibilidad al sistema de salud, acceso a medicamentos) que también podrían modificar los resultados clínicos de una enfermedad 12 y el impacto esperado de una TS sobre una determinada enfermedad o condición. 13 En lo referente al precio (o costo, según se lo mire) es importante remarcar que se debe considerar no sólo el precio de compra o la adquisición de una TS, sino también todos los costos asociados al manejo de la enfermedad, tal como señalamos previamente. 5 Es decir, una TS puede tener un alto costo de adquisición pero representar un menor costo final por resultar en un menor uso de recursos (por ejemplo, hospitalizaciones, muertes).…”