Learning curves for transfemoral transcatheter aortic valve replacement in the PARTNER-I trial

Success and safety

Sa'Ar Minha, Ron Waksman, Lowell P. Satler, Rebecca Torguson, Oluseun Alli, Charanjit Rihal, Michael Mack, Lars G. Svensson, Jeevanantham Rajeswaran, Eugene H. Blackstone, E. Murat Tuzcu, Vinod H. Thourani, Raj Makkar, John Ehrlinger, Ashley M. Lowry, Rakesh M. Suri, Kevin L. Greason, Martin B. Leon, David Holmes, Augusto D. Pichard

Research output: Contribution to journalArticle

48 Citations (Scopus)

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 ∼26 cases. However, these improved results were due to change in patient risk profile; outcomes were not linked to the technical performance learning curve.

Original languageEnglish (US)
Pages (from-to)165-175
Number of pages11
JournalCatheterization and Cardiovascular Interventions
Volume87
Issue number1
DOIs
StatePublished - Jan 1 2016

Fingerprint

Learning Curve
Safety
Length of Stay
Equipment and Supplies
Nonlinear Dynamics
Transcatheter Aortic Valve Replacement
Blood Vessels
Hemorrhage

Keywords

  • adverse events
  • device success
  • outcomes learning curves
  • transcatheter aortic valve replacement
  • transfemoral

ASJC Scopus subject areas

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

Cite this

Learning curves for transfemoral transcatheter aortic valve replacement in the PARTNER-I trial : Success and safety. / Minha, Sa'Ar; Waksman, Ron; Satler, Lowell P.; Torguson, Rebecca; Alli, Oluseun; Rihal, Charanjit; Mack, Michael; Svensson, Lars G.; Rajeswaran, Jeevanantham; Blackstone, Eugene H.; Tuzcu, E. Murat; Thourani, Vinod H.; Makkar, Raj; Ehrlinger, John; Lowry, Ashley M.; Suri, Rakesh M.; Greason, Kevin L.; Leon, Martin B.; Holmes, David; Pichard, Augusto D.

In: Catheterization and Cardiovascular Interventions, Vol. 87, No. 1, 01.01.2016, p. 165-175.

Research output: Contribution to journalArticle

Minha, SA, Waksman, R, Satler, LP, Torguson, R, Alli, O, Rihal, C, Mack, M, Svensson, LG, Rajeswaran, J, Blackstone, EH, Tuzcu, EM, Thourani, VH, Makkar, R, Ehrlinger, J, Lowry, AM, Suri, RM, Greason, KL, Leon, MB, Holmes, D & Pichard, AD 2016, 'Learning curves for transfemoral transcatheter aortic valve replacement in the PARTNER-I trial: Success and safety', Catheterization and Cardiovascular Interventions, vol. 87, no. 1, pp. 165-175. https://doi.org/10.1002/ccd.26121
Minha, Sa'Ar ; Waksman, Ron ; Satler, Lowell P. ; Torguson, Rebecca ; Alli, Oluseun ; Rihal, Charanjit ; Mack, Michael ; Svensson, Lars G. ; Rajeswaran, Jeevanantham ; Blackstone, Eugene H. ; Tuzcu, E. Murat ; Thourani, Vinod H. ; Makkar, Raj ; Ehrlinger, John ; Lowry, Ashley M. ; Suri, Rakesh M. ; Greason, Kevin L. ; Leon, Martin B. ; Holmes, David ; Pichard, Augusto D. / Learning curves for transfemoral transcatheter aortic valve replacement in the PARTNER-I trial : Success and safety. In: Catheterization and Cardiovascular Interventions. 2016 ; Vol. 87, No. 1. pp. 165-175.
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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 ∼26 cases. However, these improved results were due to change in patient risk profile; outcomes were not linked to the technical performance learning curve.",
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AU - Torguson, Rebecca

AU - Alli, Oluseun

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AU - Tuzcu, E. Murat

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AU - Suri, Rakesh M.

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AU - Leon, Martin B.

AU - Holmes, David

AU - Pichard, Augusto D.

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N2 - 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.

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