Learning curves for transfemoral transcatheter aortic valve replacement in the PARTNER-I trial: Success and safety.
Catheter Cardiovasc Interv
; 87(1): 165-75, 2016 Jan 01.
Article
em En
| MEDLINE
| ID: mdl-26425793
ABSTRACT
OBJECTIVES:
To identify number of cases needed to maximize device success and minimize adverse events after transfemoral transcatheter aortic valve replacement (TF-TAVR), and determine if adverse events were linked to the technical performance learning curve.BACKGROUND:
TF-TAVR is a complex procedure with an incompletely characterized learning curve for clinical outcomes.METHODS:
From 4/2007-2/2012, 1521 patients underwent TF-TAVR in the PARTNER-I trial. Outcomes learning curves were defined as number of cases needed to reach a plateau for device success, adverse events, and post-procedure length of stay. Institutional variation was accounted for by mixed-model non-linear techniques, which were also used to identify contribution of the procedure time learning curve to 30-day major adverse events and length of stay.RESULTS:
Eighty percent device success was achieved after 22 cases; major vascular complications fell below 5% after 70 cases and major bleeding below 10% after 25 cases. It took an average of 28 cases to achieve a consistent low risk of 30-day major adverse events, but institutions entering in the middle of the trial achieved it after about 26. The most significant correlate of 30-day major adverse events and post-procedure length of stay was procedure time (P < 0.0001). However, this association was related to patient and unmeasured variables, not the procedure time learning curve (P = 0.6).CONCLUSIONS:
By end of trial, a consistent low risk of adverse events was achieved after â¼26 cases. However, these improved results were due to change in patient risk profile; outcomes were not linked to the technical performance learning curve. © 2015 Wiley Periodicals, Inc.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Valva Aórtica
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Estenose da Valva Aórtica
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Próteses Valvulares Cardíacas
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Educação de Pós-Graduação em Medicina
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Curva de Aprendizado
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Substituição da Valva Aórtica Transcateter
Tipo de estudo:
Observational_studies
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Prognostic_studies
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Risk_factors_studies
Limite:
Aged80
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Female
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Humans
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Male
Idioma:
En
Revista:
Catheter Cardiovasc Interv
Assunto da revista:
CARDIOLOGIA
Ano de publicação:
2016
Tipo de documento:
Article