French Registry Compares TAVR Outcomes in Catheterization Labs Versus Hybrid ORs
October 30, 2018—A study of the FRANCE TAVI (French Transcatheter Aortic Valve Implantation) registry that sought to compare outcomes of patients undergoing transcatheter aortic valve replacement (TAVR) in a catheterization lab to those undergoing TAVR in a hybrid operating room (OR) was published by Marco Spaziano, MD, et al in Journal of the American College of Cardiology (JACC): Cardiovascular Interventions (2018;11:2195–2203).
The FRANCE-TAVI registry prospectively included all TAVRs performed in 48 centers across France between January 2013 and December 2015. The primary endpoint of this study was all-cause mortality at 1 year. Secondary endpoints consisted of 30-day complications and 3-year mortality. All analyses were adjusted for baseline and procedural characteristics.
As summarized in JACC: Cardiovascular Interventions, the study included a total of 12,121 patients, of which 62% underwent TAVR in a catheterization lab versus 38% in a hybrid OR. Mean age was 82.9 ±7.2 years, 48.9% of patients were men, and mean logistic EuroSCORE was 17.9% ± 12.3%. Both procedure locations showed similar rates (< 2%) of intraprocedural complications.
After adjusting for baseline and procedural characteristics, major bleeding and infections were significantly higher in the hybrid OR group (bleeding, 6.3% vs 4.8%; infection, 6.1% vs 3.5%; P < .05). Adjusted mortality rates at 1 and 3 years did not significantly differ between groups for catheterization lab versus hybrid OR (1 year, 16.2% vs 15.8%; P = .91; 3 years, 38.4% vs 36.4%; P = .49).
The findings that midterm mortality after TAVR was similar between the catheterization lab and the hybrid OR support the performance of TAVR in either location, which has important implications on health care organization and costs, concluded the FRANCE-TAVI investigators in JACC: Cardiovascular Interventions.