Professional education for transcatheter aortic valve implantation (TAVI) – a way to manage the learning curve?

ORIGINAL ARTICLE, June 2014, VOL III ISSUE I, ISSN 2042-4884
10.5083/ejcm.20424884.117 , Cite or Link Using DOI
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Martin Thoenes, Peter Bramlage, Jana Kurucova, Leen van Garsse, Alain Cribier, Francis G. Duhay, Gerhard Schymik

ABSTRACT

Introduction:
In full compliance with the ESC/EACTS guidelines, Edwards Lifesciences has implemented specific institutional requirements for prospective TAVI centers, and a comprehensive and structured training program in an effort to maximize procedural success. We report on the impact of this program on the rate of procedural success and early complications.

Methods and Results: Professional education included: (1) two days of fundamental TAVI training; (2) physician-proctored sessions; and, (3) procedure support by clinical specialists, which was repeated with each new device generation. Primary efficacy endpoint was the Procedural Success Rate (PSR), defined as freedom from death, second valve implant, and conversion to conventional surgery at the day of the procedure; and, the primary safety endpoints were procedure-related complications. Between January 2008 and December 2012 (n=14,768), PSR was 95.0% and peaked at 97.6% with evidence of a learning curve for transapical (93.5-97.4%) but not transfemoral procedures. Procedure-related complications were low (< 1%). Most frequent were ventricular embolization (n = 43; 0.41%), valvular/paravalvular leakage (n = 41; 0.39%) and aortic embolization (n = 35; 0.34%). Procedure failures were low (2010-2012; 10,422 patients) with valve-in-valve (0.7%), conversion to surgery (0.85%), and early mortality (0.82%) with no major change over time. Introduction of new device technology was associated with an increase in PSR from 96.4% to 98.5%.

Conclusions: These data demonstrated that a comprehensive, structured training program is effective in centers in which a new TAVI program is initiated or new device technology introduced.