MedStar Authors catalog › Details for: Learning curves for transfemoral transcatheter aortic valve replacement in the PARTNER-I trial: Success and safety.
Learning curves for transfemoral transcatheter aortic valve replacement in the PARTNER-I trial: Success and safety. Journal: Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions.Published: 2016ISSN: 1522-1946.UI/PMID: 26425793.Subject(s): Aged, 80 and over | *Aortic Valve/su [Surgery] | *Aortic Valve Stenosis/su [Surgery] | *Education, Medical, Graduate/mt [Methods] | Female | Femoral Artery | *Heart Valve Prosthesis | Humans | *Learning Curve | Male | Retrospective Studies | Severity of Illness Index | *Transcatheter Aortic Valve Replacement/ed [Education] | Transcatheter Aortic Valve Replacement/mt [Methods] | Treatment OutcomeInstitution(s): MedStar Heart & Vascular InstituteActivity type: Journal Article.Medline article type(s): Journal Article | Multicenter Study | Randomized Controlled TrialDigital Object Identifier: https://dx.doi.org/10.1002/ccd.26121 (Click here) Abbreviated citation: Catheter Cardiovasc Interv. 87(1):165-75, 2016 Jan 01.Local Holdings: Available online from MWHC library: 1996 - present, Available in print through MWHC library: 1996 - 2006.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.Abstract: BACKGROUND: TF-TAVR is a complex procedure with an incompletely characterized learning curve for clinical outcomes.Abstract: 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.Abstract: 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).Abstract: 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.Abstract: Copyright © 2015 Wiley Periodicals, Inc.