Author + information
- Received September 26, 2017
- Revision received May 28, 2018
- Accepted June 26, 2018
- Published online September 3, 2018.
- Anthony W.A. Wassef, MDa,
- Josep Rodes-Cabau, MDb,
- Yaqing Liu, MSca,
- John G. Webb, MDc,
- Marco Barbanti, MDd,
- Antonio J. Muñoz-García, MD, PhDe,
- Corrado Tamburino, MD, PhDd,
- Antonio E. Dager, MDf,
- Vicenç Serra, MDg,
- Ignacio J. Amat-Santos, MD, PhDh,
- Juan H. Alonso Briales, MDe,
- Alberto San Roman, MDh,
- Marina Urena, MD, PhDi,
- Dominique Himbert, MDi,
- Lius Nombela-Franco, MD, PhDj,
- Alexandre Abizaid, MD, PhDk,
- Fabio S. de Brito Jr., MDl,
- Henrique B. Ribeiro, MD, PhDm,
- Marc Ruel, MDn,
- Valter C. Lima, MDo,
- Fabian Nietlispach, MDp and
- Asim N. Cheema, MD, PhDa,∗ ()
- aDivision of Cardiology, Department of Medicine, St. Michael’s Hospital, Toronto, Canada
- bQuebec Heart & Lung Institute, Laval University, Quebec City, Canada
- cDivision of Cardiology, Department of Medicine, St. Paul’s Hospital, University of British Columbia, Vancouver, Canada
- dDivision of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy
- eDepartment of Cardiology, Hospital Universitario Virgen de la Victoria, Universidad de Málaga, Málaga, Spain
- fDepartment of Cardiology, Clínica de Occidente de Cali, Cali, Colombia
- gDepartment of Interventional Cardiology, Hospital Universitari Vall d’Hebron, Universitat Autònoma de Barcelona, Barcelona, Spain
- hCIBERCV, Hospital Clínico Universitario de Valladolid, Valladolid, Spain
- iDepartment of Cardiology, Bichat Hôpital, AP-HP, University Paris Diderot, Paris, France
- jInstituto Cardiovascular, Hospital Universitario Clínico San Carlos, Madrid, Spain
- kInstituto Dante Pazzanese de Cardiologia, São Paulo, Brazil
- lInterventional Cardiology Department, Hospital Israelita Albert Einstein, São Paulo, Brazil
- mHeart Institute (InCor), São Paulo, Brazil
- nDivision of Cardiac Surgery, Ottawa Heart Institute, Ottawa, Canada
- oHospital São Francisco-Santa Casa de Misericórdia de Porto Alegre, Porto Alegre, Brazil
- pUniversity Hospital Zürich, Zürich, Switzerland
- ↵∗Address for correspondence:
Dr. Asim N. Cheema, Division of Cardiology, St. Michael's Hospital, 30 Bond Street, Toronto, Ontario M5B 1W8, Canada.
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.
Dr. Rodes-Cabau has received research grants from Edwards Lifesciences and Medtronic. Dr. Webb has received research grants from and served as a consultant for Edwards Lifesciences and Abbott. Dr. Barbanti has served as a consultant for Edwards Lifesciences. Dr. Ruel has received research grants from Medtronic and Edwards Lifesciences. Dr. Himbert has served as a proctor for Edwards Lifesciences and Medtronic. Dr. Nombela-Franco has served as a proctor for Abbott. Dr. Abizaid has served as a proctor for Edwards Lifesciences. Drs. de Brito and Nietlispach has served as a consultant for Edwards Lifesciences, Abbott, and Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received September 26, 2017.
- Revision received May 28, 2018.
- Accepted June 26, 2018.
- 2018 American College of Cardiology Foundation