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 underwentTF-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 ∼26 cases. However, these improved results were due to change in patient risk profile; outcomes were not linked to the technical performance learning curve.
RCT Entities:
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 ∼26 cases. However, these improved results were due to change in patient risk profile; outcomes were not linked to the technical performance learning curve.
Authors: Sahil Khera; Dhaval Kolte; Tanush Gupta; Andrew Goldsweig; Poonam Velagapudi; Ankur Kalra; Gilbert H L Tang; Wilbert S Aronow; Gregg C Fonarow; Deepak L Bhatt; Herbert D Aronow; Neal S Kleiman; Michael Reardon; Paul C Gordon; Barry Sharaf; J Dawn Abbott Journal: JAMA Cardiol Date: 2017-07-01 Impact factor: 14.676
Authors: Matthew C Henn; Thomas Percival; Alan Zajarias; Spencer J Melby; Brian R Lindman; Nishath Quader; Ralph J Damiano; Marc R Moon; John M Lasala; Ravinder S Rao; Jennifer Bell; Marci S Damiano; Hersh S Maniar Journal: Ann Thorac Surg Date: 2016-10-17 Impact factor: 4.330
Authors: Rakesh M Suri; Sa'ar Minha; Oluseun Alli; Ron Waksman; Charanjit S Rihal; Lowell P Satler; Kevin L Greason; Rebecca Torguson; Augusto D Pichard; Michael Mack; Lars G Svensson; Jeevanantham Rajeswaran; Ashley M Lowry; John Ehrlinger; Stephanie L Mick; E Murat Tuzcu; Vinod H Thourani; Raj Makkar; David Holmes; Martin B Leon; Eugene H Blackstone Journal: J Thorac Cardiovasc Surg Date: 2016-04-13 Impact factor: 5.209
Authors: Fleur V Y Tjong; Niek E G Beurskens; Petr Neuzil; Pascal Defaye; Peter-Paul Delnoy; John Ip; Juan Jose Garcia Guerrero; Mayer Rashtian; Rajesh Banker; Vivek Reddy; Derek Exner; Johannes Sperzel; Reinoud E Knops Journal: J Interv Card Electrophysiol Date: 2018-08-13 Impact factor: 1.900