Anthony W A Wassef1, Josep Rodes-Cabau2, Yaqing Liu1, John G Webb3, Marco Barbanti4, Antonio J Muñoz-García5, Corrado Tamburino4, Antonio E Dager6, Vicenç Serra7, Ignacio J Amat-Santos8, Juan H Alonso Briales5, Alberto San Roman8, Marina Urena9, Dominique Himbert9, Lius Nombela-Franco10, Alexandre Abizaid11, Fabio S de Brito12, Henrique B Ribeiro13, Marc Ruel14, Valter C Lima15, Fabian Nietlispach16, Asim N Cheema17. 1. Division of Cardiology, Department of Medicine, St. Michael's Hospital, Toronto, Canada. 2. Quebec Heart & Lung Institute, Laval University, Quebec City, Canada. 3. Division of Cardiology, Department of Medicine, St. Paul's Hospital, University of British Columbia, Vancouver, Canada. 4. Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy. 5. Department of Cardiology, Hospital Universitario Virgen de la Victoria, Universidad de Málaga, Málaga, Spain. 6. Department of Cardiology, Clínica de Occidente de Cali, Cali, Colombia. 7. Department of Interventional Cardiology, Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Barcelona, Spain. 8. CIBERCV, Hospital Clínico Universitario de Valladolid, Valladolid, Spain. 9. Department of Cardiology, Bichat Hôpital, AP-HP, University Paris Diderot, Paris, France. 10. Instituto Cardiovascular, Hospital Universitario Clínico San Carlos, Madrid, Spain. 11. Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil. 12. Interventional Cardiology Department, Hospital Israelita Albert Einstein, São Paulo, Brazil. 13. Heart Institute (InCor), São Paulo, Brazil. 14. Division of Cardiac Surgery, Ottawa Heart Institute, Ottawa, Canada. 15. Hospital São Francisco-Santa Casa de Misericórdia de Porto Alegre, Porto Alegre, Brazil. 16. University Hospital Zürich, Zürich, Switzerland. 17. Division of Cardiology, Department of Medicine, St. Michael's Hospital, Toronto, Canada. Electronic address: cheemaa@smh.ca.
Abstract
OBJECTIVES: The authors aimed to determine the procedural learning curve and minimum annual institutional volumes associated with optimum clinical outcomes for transcatheter aortic valve replacement (TAVR). BACKGROUND: Transcatheter aortic valve replacement (TAVR) is a complex procedure requiring significant training and experience for successful outcome. Despite increasing use of TAVR across institutions, limited information is available for its learning curve characteristics and minimum annual volumes required to optimize clinical outcomes. METHODS: The study collected data for patients at 16 centers participating in the international TAVR registry since initiation of the respective TAVR program. All cases were chronologically ordered into initial (1 to 75), early (76 to 150), intermediate (151 to 225), high (226 to 300), and very high (>300) experience operators for TAVR learning curve characterization. In addition, participating institutions were stratified by annual TAVR case volume into low-volume (<50), moderate-volume (50 to 100), and high-volume (>100) groups for comparative analysis. Procedural and 30-day clinical outcomes were collected and multivariate regression analysis performed for 30-day mortality and the early safety endpoint. RESULTS: A total of 3,403 patients comprised the study population. On multivariate analysis, all-cause mortality was significantly higher for initial (odds ratio [OR]: 3.83; 95% confidence interval [CI]: 1.93 to 7.60), early (OR: 2.41; 95% CI: 1.51 to 5.03), and intermediate (OR: 2.53; 95% CI: 1.19 to 5.40) experience groups compared with the very high experience operators. In addition, the early safety endpoint was significantly worse for all experience groups compared with the very high experience operators. Low annual volume (<50) TAVR institutions had significantly higher all-cause 30-day mortality (OR: 2.70; 95% CI: 1.44 to 5.07) and worse early safety endpoint (OR: 1.60; 95% CI: 1.17 to 2.17) compared with the moderate- and high-volume groups. There was no difference in patient outcomes between intermediate and high annual volume groups. CONCLUSIONS: TAVR procedures display important learning curve characteristics with both greater procedural safety and a lower mortality when performed by experienced operators. In addition, TAVR performed at low annual volume (<50 procedures) institutions is associated with decreased procedural safety and higher patient mortality. These findings have important implications for operator training and patient care at centers performing TAVR.
OBJECTIVES: The authors aimed to determine the procedural learning curve and minimum annual institutional volumes associated with optimum clinical outcomes for transcatheter aortic valve replacement (TAVR). BACKGROUND: Transcatheter aortic valve replacement (TAVR) is a complex procedure requiring significant training and experience for successful outcome. Despite increasing use of TAVR across institutions, limited information is available for its learning curve characteristics and minimum annual volumes required to optimize clinical outcomes. METHODS: The study collected data for patients at 16 centers participating in the international TAVR registry since initiation of the respective TAVR program. All cases were chronologically ordered into initial (1 to 75), early (76 to 150), intermediate (151 to 225), high (226 to 300), and very high (>300) experience operators for TAVR learning curve characterization. In addition, participating institutions were stratified by annual TAVR case volume into low-volume (<50), moderate-volume (50 to 100), and high-volume (>100) groups for comparative analysis. Procedural and 30-day clinical outcomes were collected and multivariate regression analysis performed for 30-day mortality and the early safety endpoint. RESULTS: A total of 3,403 patients comprised the study population. On multivariate analysis, all-cause mortality was significantly higher for initial (odds ratio [OR]: 3.83; 95% confidence interval [CI]: 1.93 to 7.60), early (OR: 2.41; 95% CI: 1.51 to 5.03), and intermediate (OR: 2.53; 95% CI: 1.19 to 5.40) experience groups compared with the very high experience operators. In addition, the early safety endpoint was significantly worse for all experience groups compared with the very high experience operators. Low annual volume (<50) TAVR institutions had significantly higher all-cause 30-day mortality (OR: 2.70; 95% CI: 1.44 to 5.07) and worse early safety endpoint (OR: 1.60; 95% CI: 1.17 to 2.17) compared with the moderate- and high-volume groups. There was no difference in patient outcomes between intermediate and high annual volume groups. CONCLUSIONS: TAVR procedures display important learning curve characteristics with both greater procedural safety and a lower mortality when performed by experienced operators. In addition, TAVR performed at low annual volume (<50 procedures) institutions is associated with decreased procedural safety and higher patientmortality. These findings have important implications for operator training and patient care at centers performing TAVR.
Authors: Gudrun Lamm; Matthias Hammerer; Uta C Hoppe; Martin Andreas; Rudolf Berger; Ronald K Binder; Nikolaos Bonaros; Georg Delle-Karth; Matthias Frick; Michael Grund; Bernhard Metzler; Thomas Neunteufl; Philipp Pichler; Albrecht Schmidt; Wilfried Wisser; Andreas Zierer; Rainald Seitelberger; Michael Grimm; Alexander Geppert Journal: Wien Klin Wochenschr Date: 2021-03-23 Impact factor: 1.704
Authors: Sameer A Hirji; Ellen McCarthy; Dae Kim; Siobhan McGurk; Julius Ejiofor; Fernando Ramirez-Del Val; Ahmed A Kolkailah; Bernard Rosner; Douglas Shook; Charles Nyman; Natalia Berry; Piotr Sobieszczyk; Marc Pelletier; Pinak Shah; Patrick O'Gara; Tsuyoshi Kaneko Journal: JACC Cardiovasc Interv Date: 2020-02-10 Impact factor: 11.195
Authors: G J van Steenbergen; D van Veghel; D N Schulz; M Soliman-Hamad; P A Tonino; S Houterman; L Dekker Journal: Neth Heart J Date: 2020-12-07 Impact factor: 2.380
Authors: Amgad Mentias; Marwan Saad; Milind Y Desai; Phillip A Horwitz; James D Rossen; Sidakpal Panaich; Ayman Elbadawi; Abdul Qazi; Paul Sorajja; Hani Jneid; Samir Kapadia; Barry London; Mary S Vaughan Sarrazin Journal: J Am Heart Assoc Date: 2019-10-31 Impact factor: 5.501