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The learning curve in transcatheter aortic valve implantation clinical studies: A systematic review

Published online by Cambridge University Press:  21 April 2020

Anne-Pauline Thivilliers
Affiliation:
Pharmacy Department, Georges Pompidou European Hospital, AP-HP, 20 Rue Leblanc, 75015Paris, France
Rémi Ladarré
Affiliation:
Pharmacy Department, Georges Pompidou European Hospital, AP-HP, 20 Rue Leblanc, 75015Paris, France
Océane Merabti
Affiliation:
Pharmacy Department, Georges Pompidou European Hospital, AP-HP, 20 Rue Leblanc, 75015Paris, France
Caroline François
Affiliation:
Pharmacy Department, Georges Pompidou European Hospital, AP-HP, 20 Rue Leblanc, 75015Paris, France
Sarah Fontenay
Affiliation:
Pharmacy Department, Georges Pompidou European Hospital, AP-HP, 20 Rue Leblanc, 75015Paris, France
Hélène van den Brink
Affiliation:
Faculty of Pharmacy, University Paris-Sud, GRADES, 5 Rue Jean-Baptiste Clément, 92290 Châtenay-Malabry, France
Judith Pineau
Affiliation:
Pharmacy Department, Georges Pompidou European Hospital, AP-HP, 20 Rue Leblanc, 75015Paris, France
Patrice Prognon
Affiliation:
Pharmacy Department, Georges Pompidou European Hospital, AP-HP, 20 Rue Leblanc, 75015Paris, France
Isabelle Borget
Affiliation:
Department of Health Economics, Gustave Roussy Institute, 114, Rue Edouard-Vaillant, 94805Villejuif, France Faculty of Pharmacy, University Paris-Sud, GRADES, 5 Rue Jean-Baptiste Clément, 92290 Châtenay-Malabry, France
Nicolas Martelli
Affiliation:
Pharmacy Department, Georges Pompidou European Hospital, AP-HP, 20 Rue Leblanc, 75015Paris, France Faculty of Pharmacy, University Paris-Sud, GRADES, 5 Rue Jean-Baptiste Clément, 92290 Châtenay-Malabry, France

Abstract

Background

Transcatheter aortic-valve implantation (TAVI) has become an essential alternative to surgical aortic-valve replacement in the treatment of symptomatic severe aortic stenosis, and this procedure requires technical expertise. The aim of this study was to identify prospective studies on TAVI from the past 10 years, and then to analyze the quality of information reported about the learning curve.

Materials and methods

A systematic review of articles published between 2007 and 2017 was performed using PubMed and the EMBASE database. Prospective studies regarding TAVI were included. The quality of information reported about the learning curve was evaluated using the following criteria: mention of the learning curve, the description of a roll-in phase, the involvement of a proctor, and the number of patients suggested to maintain skills.

Results

A total of sixty-eight studies met the selection criteria and were suitable for analysis. The learning curve was addressed in approximately half of the articles (n = 37, 54 percent). However, the roll-in period was mentioned by only eight studies (12 percent) and with very few details. Furthermore, a proctorship was disclosed in three articles (4 percent) whereas twenty-five studies (37 percent) included authors that were proctors for manufacturers of TAVI.

Conclusion

Many prospective studies on TAVI over the past 10 years mention learning curves as a core component of successful TAVI procedures. However, the quality of information reported about the learning curve is relatively poor, and uniform guidance on how to properly assess the learning curve is still missing.

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Assessment
Copyright
Copyright © Cambridge University Press 2020

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