Xavier Armoiry1, Jean-François Obadia2, Léa Pascal3, Stéphanie Polazzi4, Antoine Duclos5. 1. Division of Health Sciences, Warwick Medical School, University of Warwick, Coventry, England; Hospices Civils de Lyon/Quai des Célestins, Lyon, France; UMR-CNRS 5510/MATEIS, Lyon, France. Electronic address: armoiryxa@gmail.com. 2. Service de Chirurgie Cardio-thoracique et Transplantation, Hôpital Cardio-thoracique Louis Pradel, Lyon-Bron, Bron, France. 3. Hospices Civils de Lyon, Pôle de Santé Publique, Service des Données de Santé, Lyon, France. 4. Hospices Civils de Lyon, Pôle de Santé Publique, Service des Données de Santé, Lyon, France; Université Claude Bernard Lyon 1, Health Services and Performance Research lab (HESPER EA7425), F-69008, Lyon, France. 5. Hospices Civils de Lyon, Pôle de Santé Publique, Service des Données de Santé, Lyon, France; Université Claude Bernard Lyon 1, Health Services and Performance Research lab (HESPER EA7425), F-69008, Lyon, France; Center for Surgery and Public Health, Brigham and Women's Hospital, Harvard Medical School, Boston, Mass.
Abstract
OBJECTIVE: To compare the clinical outcomes and direct costs at 5 years between transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) using real-world evidence. METHODS: We performed a nationwide longitudinal study using data from the French Hospital Information System from 2009 to 2015. We matched, inside hospitals, 2 cohorts of adults who underwent TAVI or SAVR during 2010 on propensity score based on patient characteristics. Outcomes analysis included mortality, morbidity, and total costs and with a maximum 60-month follow-up. Clinical outcomes were compared between cohorts using hazard ratios (HRs) estimated from a Cox proportional hazards model for all-cause death, and from Fine and Gray's competing risk model for morbidity. RESULTS: Based on a cohort of 1598 patients (799 in each group) from 27 centers, a higher risk of death was observed after 1 year with TAVI compared with SAVR (16.8% vs 12.8%, respectively; HR, 1.33; 95% confidence interval [CI], 1.02-1.72) and was sustained up to 5 years (52.4% vs 37.2%; HR, 1.56; 95% CI, 1.33-1.84). At 5 years, the risk of stroke was increased (HR, 1.64; 95% CI, 1.07-2.54) as was myocardial infarction (HR, 2.30; 95% CI, 1.12-4.69) and pacemaker implantation (HR, 2.40; 95% CI, 1.81-3.17) after TAVI. The hospitalization costs per patient at 5 years were €69,083 after TAVI and €55,687 after SAVR (P < .001). CONCLUSIONS: In our study, high-risk patients harbored a greater risk of mortality and morbidity at 5 years after TAVI compared with those who underwent SAVR and higher hospitalizations costs. Those results should encourage caution before expanding the indications of TAVI.
OBJECTIVE: To compare the clinical outcomes and direct costs at 5 years between transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR) using real-world evidence. METHODS: We performed a nationwide longitudinal study using data from the French Hospital Information System from 2009 to 2015. We matched, inside hospitals, 2 cohorts of adults who underwent TAVI or SAVR during 2010 on propensity score based on patient characteristics. Outcomes analysis included mortality, morbidity, and total costs and with a maximum 60-month follow-up. Clinical outcomes were compared between cohorts using hazard ratios (HRs) estimated from a Cox proportional hazards model for all-cause death, and from Fine and Gray's competing risk model for morbidity. RESULTS: Based on a cohort of 1598 patients (799 in each group) from 27 centers, a higher risk of death was observed after 1 year with TAVI compared with SAVR (16.8% vs 12.8%, respectively; HR, 1.33; 95% confidence interval [CI], 1.02-1.72) and was sustained up to 5 years (52.4% vs 37.2%; HR, 1.56; 95% CI, 1.33-1.84). At 5 years, the risk of stroke was increased (HR, 1.64; 95% CI, 1.07-2.54) as was myocardial infarction (HR, 2.30; 95% CI, 1.12-4.69) and pacemaker implantation (HR, 2.40; 95% CI, 1.81-3.17) after TAVI. The hospitalization costs per patient at 5 years were €69,083 after TAVI and €55,687 after SAVR (P < .001). CONCLUSIONS: In our study, high-risk patients harbored a greater risk of mortality and morbidity at 5 years after TAVI compared with those who underwent SAVR and higher hospitalizations costs. Those results should encourage caution before expanding the indications of TAVI.
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Authors: Xiling Zhang; Thomas Puehler; Derk Frank; Janarthanan Sathananthan; Stephanie Sellers; David Meier; Marcus Both; Philipp Blanke; Hatim Seoudy; Mohammed Saad; Oliver J Müller; Lars Sondergaard; Georg Lutter Journal: J Cardiovasc Dev Dis Date: 2022-07-12
Authors: Stephanie Louise Swift; Thomas Puehler; Kate Misso; Shona Helen Lang; Carol Forbes; Jos Kleijnen; Marion Danner; Christian Kuhn; Assad Haneya; Hatim Seoudy; Jochen Cremer; Norbert Frey; Georg Lutter; Robert Wolff; Fueloep Scheibler; Kai Wehkamp; Derk Frank Journal: BMJ Open Date: 2021-12-06 Impact factor: 2.692