Journal article
The Learning Curve and Annual Procedure Volume Standards for Optimum Outcomes of Transcatheter Aortic Valve Replacement: Findings From an International Registry.
- Wassef AWA Division of Cardiology, Department of Medicine, St. Michael's Hospital, Toronto, Canada.
- Rodes-Cabau J Quebec Heart & Lung Institute, Laval University, Quebec City, Canada.
- Liu Y Division of Cardiology, Department of Medicine, St. Michael's Hospital, Toronto, Canada.
- Webb JG Division of Cardiology, Department of Medicine, St. Paul's Hospital, University of British Columbia, Vancouver, Canada.
- Barbanti M Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
- Muñoz-García AJ Department of Cardiology, Hospital Universitario Virgen de la Victoria, Universidad de Málaga, Málaga, Spain.
- Tamburino C Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
- Dager AE Department of Cardiology, Clínica de Occidente de Cali, Cali, Colombia.
- Serra V Department of Interventional Cardiology, Hospital Universitari Vall d'Hebron, Universitat Autònoma de Barcelona, Barcelona, Spain.
- Amat-Santos IJ CIBERCV, Hospital Clínico Universitario de Valladolid, Valladolid, Spain.
- Alonso Briales JH Department of Cardiology, Hospital Universitario Virgen de la Victoria, Universidad de Málaga, Málaga, Spain.
- San Roman A CIBERCV, Hospital Clínico Universitario de Valladolid, Valladolid, Spain.
- Urena M Department of Cardiology, Bichat Hôpital, AP-HP, University Paris Diderot, Paris, France.
- Himbert D Department of Cardiology, Bichat Hôpital, AP-HP, University Paris Diderot, Paris, France.
- Nombela-Franco L Instituto Cardiovascular, Hospital Universitario Clínico San Carlos, Madrid, Spain.
- Abizaid A Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.
- de Brito FS Interventional Cardiology Department, Hospital Israelita Albert Einstein, São Paulo, Brazil.
- Ribeiro HB Heart Institute (InCor), São Paulo, Brazil.
- Ruel M Division of Cardiac Surgery, Ottawa Heart Institute, Ottawa, Canada.
- Lima VC Hospital São Francisco-Santa Casa de Misericórdia de Porto Alegre, Porto Alegre, Brazil.
- Nietlispach F University Hospital Zürich, Zürich, Switzerland.
- Cheema AN Division of Cardiology, Department of Medicine, St. Michael's Hospital, Toronto, Canada. Electronic address: cheemaa@smh.ca.
- 2018-09-08
Published in:
- JACC. Cardiovascular interventions. - 2018
learning curve
transcatheter aortic valve replacement
volume-outcome relationship
Aged
Aged, 80 and over
Clinical Competence
Female
Hospitals, High-Volume
Hospitals, Low-Volume
Humans
Learning Curve
Male
Outcome and Process Assessment, Health Care
Patient Safety
Postoperative Complications
Registries
Risk Factors
Surgeons
Time Factors
Transcatheter Aortic Valve Replacement
Treatment Outcome
Workload
English
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.
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.
- Language
-
- English
- Open access status
- bronze
- Identifiers
-
- DOI 10.1016/j.jcin.2018.06.044
- PMID 30190058
- Persistent URL
- https://sonar.ch/global/documents/47419
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