Corrado Tamburino1, Marco Barbanti2, Paola D'Errigo3, Marco Ranucci4, Francesco Onorati5, Remo Daniel Covello6, Francesco Santini7, Stefano Rosato4, Gennaro Santoro8, Danilo Fusco9, Claudio Grossi10, Fulvia Seccareccia3. 1. Division of Cardiology, Ferrarotto Hospital, University of Catania, Italy; ETNA Foundation, Catania, Italy. 2. Division of Cardiology, Ferrarotto Hospital, University of Catania, Italy; ETNA Foundation, Catania, Italy. Electronic address: mbarbanti83@gmail.com. 3. National Centre for Epidemiology, Surveillance and Health Promotion, Istituto Superiore di Sanità, Rome, Italy. 4. Department of Cardiothoracic and Vascular Anesthesia and ICU, IRCCS Policlinico San Donato, San Donato Milanese, Milan, Italy. 5. Division of Cardiac Surgery, University of Verona Medical School, Verona, Italy. 6. Department of Cardiac Anesthesia, IRCCS San Raffaele, Milan, Italy. 7. Division of Cardiac Surgery, San Martino Hospital, Genova, Italy. 8. Division of Cardiology, Careggi Hospital, Florence, Italy. 9. Department of Epidemiology, Lazio Regional Health Service, Rome, Italy. 10. Division of Cardiac Surgery, ASO S. Croce e Carle, Cuneo, Italy.
Abstract
BACKGROUND: There is a paucity of prospective and controlled data on the comparative effectiveness of transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR) in a real-world setting. OBJECTIVES: This analysis aims to describe 1-year clinical outcomes of a large series of propensity-matched patients who underwent SAVR and transfemoral TAVR. METHODS: The OBSERVANT (Observational Study of Effectiveness of SAVR-TAVI Procedures for Severe Aortic Stenosis Treatment) trial is an observational prospective multicenter cohort study that enrolled patients with aortic stenosis (AS) who underwent SAVR or TAVR. The propensity score method was applied to select 2 groups with similar baseline characteristics. All outcomes were adjudicated through a linkage with administrative databases. The primary endpoints of this analysis were death from any cause and major adverse cardiac and cerebrovascular events (MACCE) at 1 year. RESULTS: The unadjusted enrolled population (N = 7,618) included 5,707 SAVR patients and 1,911 TAVR patients. The matched population had a total of 1,300 patients (650 per group). The propensity score method generated a low-intermediate risk population (mean logistic EuroSCORE 1: 10.2 ± 9.2% vs. 9.5 ± 7.1%, SAVR vs. transfemoral TAVR; p = 0.104). At 1 year, the rate of death from any cause was 13.6% in the surgical group and 13.8% in the transcatheter group (hazard ratio [HR]: 0.99; 95% confidence interval [CI]: 0.72 to 1.35; p = 0.936). Similarly, there were no significant differences in the rates of MACCE, which were 17.6% in the surgical group and 18.2% in the transcatheter group (HR: 1.03; 95% CI: 0.78 to 1.36; p = 0.831). The cumulative incidence of cerebrovascular events, and rehospitalization due to cardiac reasons and acute heart failure was similar in both groups at 1 year. CONCLUSIONS: The results suggest that SAVR and transfemoral TAVR have comparable mortality, MACCE, and rates of rehospitalization due to cardiac reasons at 1 year. These data need to be confirmed in longer term and dedicated ongoing randomized trials.
BACKGROUND: There is a paucity of prospective and controlled data on the comparative effectiveness of transcatheter aortic valve replacement (TAVR) versus surgical aortic valve replacement (SAVR) in a real-world setting. OBJECTIVES: This analysis aims to describe 1-year clinical outcomes of a large series of propensity-matched patients who underwent SAVR and transfemoral TAVR. METHODS: The OBSERVANT (Observational Study of Effectiveness of SAVR-TAVI Procedures for Severe Aortic Stenosis Treatment) trial is an observational prospective multicenter cohort study that enrolled patients with aortic stenosis (AS) who underwent SAVR or TAVR. The propensity score method was applied to select 2 groups with similar baseline characteristics. All outcomes were adjudicated through a linkage with administrative databases. The primary endpoints of this analysis were death from any cause and major adverse cardiac and cerebrovascular events (MACCE) at 1 year. RESULTS: The unadjusted enrolled population (N = 7,618) included 5,707 SAVR patients and 1,911 TAVR patients. The matched population had a total of 1,300 patients (650 per group). The propensity score method generated a low-intermediate risk population (mean logistic EuroSCORE 1: 10.2 ± 9.2% vs. 9.5 ± 7.1%, SAVR vs. transfemoral TAVR; p = 0.104). At 1 year, the rate of death from any cause was 13.6% in the surgical group and 13.8% in the transcatheter group (hazard ratio [HR]: 0.99; 95% confidence interval [CI]: 0.72 to 1.35; p = 0.936). Similarly, there were no significant differences in the rates of MACCE, which were 17.6% in the surgical group and 18.2% in the transcatheter group (HR: 1.03; 95% CI: 0.78 to 1.36; p = 0.831). The cumulative incidence of cerebrovascular events, and rehospitalization due to cardiac reasons and acute heart failure was similar in both groups at 1 year. CONCLUSIONS: The results suggest that SAVR and transfemoral TAVR have comparable mortality, MACCE, and rates of rehospitalization due to cardiac reasons at 1 year. These data need to be confirmed in longer term and dedicated ongoing randomized trials.
Authors: Anna Kostopoulou; Panagiotis Karyofillis; Efthimios Livanis; George Karavolias; George Theodorakis; John Paraskevaides; Vassilis Voudris Journal: Curr Treat Options Cardiovasc Med Date: 2016-02
Authors: Zhenglun Alan Wei; Simon Johannes Sonntag; Milan Toma; Shelly Singh-Gryzbon; Wei Sun Journal: Cardiovasc Eng Technol Date: 2018-04-19 Impact factor: 2.495
Authors: Adam Chakos; Ashley Wilson-Smith; Sameer Arora; Tom C Nguyen; Abhijeet Dhoble; Giuseppe Tarantini; Matthias Thielmann; John P Vavalle; Daniel Wendt; Tristan D Yan; David H Tian Journal: Ann Cardiothorac Surg Date: 2017-09
Authors: Susheel Kodali; Vinod H Thourani; Jonathon White; S Chris Malaisrie; Scott Lim; Kevin L Greason; Mathew Williams; Mayra Guerrero; Andrew C Eisenhauer; Samir Kapadia; Dean J Kereiakes; Howard C Herrmann; Vasilis Babaliaros; Wilson Y Szeto; Rebecca T Hahn; Philippe Pibarot; Neil J Weissman; Jonathon Leipsic; Philipp Blanke; Brian K Whisenant; Rakesh M Suri; Raj R Makkar; Girma M Ayele; Lars G Svensson; John G Webb; Michael J Mack; Craig R Smith; Martin B Leon Journal: Eur Heart J Date: 2016-03-31 Impact factor: 29.983