Learning curves for transfemoral transcatheter aortic valve replacement in the PARTNER-I trial: Success and safety.
Citation: Catheterization & Cardiovascular Interventions. 87(1):165-75, 2016 Jan 01PMID: 26425793Institution: MedStar Heart & Vascular InstituteForm of publication: Journal ArticleMedline article type(s): Journal Article | Multicenter Study | Randomized Controlled TrialSubject headings: *Aortic Valve Stenosis/su [Surgery] | *Aortic Valve/su [Surgery] | *Education, Medical, Graduate/mt [Methods] | *Heart Valve Prosthesis | *Learning Curve | *Transcatheter Aortic Valve Replacement/ed [Education] | Aged, 80 and over | Female | Femoral Artery | Humans | Male | Retrospective Studies | Severity of Illness Index | Transcatheter Aortic Valve Replacement/mt [Methods] | Treatment OutcomeYear: 2016Local holdings: Available online from MWHC library: 1996 - present, Available in print through MWHC library: 1996 - 2006ISSN:- 1522-1946
Item type | Current library | Collection | Call number | Status | Date due | Barcode |
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Journal Article | MedStar Authors Catalog | Article | 26425793 | Available | 26425793 |
Available online from MWHC library: 1996 - present, Available in print through MWHC library: 1996 - 2006
BACKGROUND: TF-TAVR is a complex procedure with an incompletely characterized learning curve for clinical outcomes.
CONCLUSIONS: By end of trial, a consistent low risk of adverse events was achieved after ~26 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.
Copyright © 2015 Wiley Periodicals, Inc.
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.
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.
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).
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