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. 2016 Sep;152(3):773-780.e14.
doi: 10.1016/j.jtcvs.2016.04.028. Epub 2016 Apr 13.

Learning curves for transapical transcatheter aortic valve replacement in the PARTNER-I trial: Technical performance, success, and safety

Rakesh M Suri  1 , Sa'ar Minha  2 , Oluseun Alli  3 , Ron Waksman  4 , Charanjit S Rihal  5 , Lowell P Satler  4 , Kevin L Greason  5 , Rebecca Torguson  4 , Augusto D Pichard  4 , Michael Mack  6 , Lars G Svensson  7 , Jeevanantham Rajeswaran  7 , Ashley M Lowry  7 , John Ehrlinger  7 , Stephanie L Mick  7 , E Murat Tuzcu  7 , Vinod H Thourani  8 , Raj Makkar  9 , David Holmes  5 , Martin B Leon  10 , Eugene H Blackstone  7
Affiliations

Learning curves for transapical transcatheter aortic valve replacement in the PARTNER-I trial: Technical performance, success, and safety

Rakesh M Suri et al. J Thorac Cardiovasc Surg. 2016 Sep.

Abstract

Objectives: Introduction of hybrid techniques, such as transapical transcatheter aortic valve replacement (TA-TAVR), requires skills that a heart team must master to achieve technical efficiency: the technical performance learning curve. To date, the learning curve for TA-TAVR remains unknown. We therefore evaluated the rate at which technical performance improved, assessed change in occurrence of adverse events in relation to technical performance, and determined whether adverse events after TA-TAVR were linked to acquiring technical performance efficiency (the learning curve).

Methods: From April 2007 to February 2012, 1100 patients, average age 85.0 ± 6.4 years, underwent TA-TAVR in the PARTNER-I trial. Learning curves were defined by institution-specific patient sequence number using nonlinear mixed modeling.

Results: Mean procedure time decreased from 131 to 116 minutes within 30 cases (P = .06) and device success increased to 90% by case 45 (P = .0007). Within 30 days, 354 patients experienced a major adverse event (stroke in 29, death in 96), with possibly decreased complications over time (P ∼ .08). Although longer procedure time was associated with more adverse events (P < .0001), these events were associated with change in patient risk profile, not the technical performance learning curve (P = .8).

Conclusions: The learning curve for TA-TAVR was 30 to 45 procedures performed, and technical efficiency was achieved without compromising patient safety. Although fewer patients are now undergoing TAVR via nontransfemoral access, understanding TA-TAVR learning curves and their relationship with outcomes is important as the field moves toward next-generation devices, such as those to replace the mitral valve, delivered via the left ventricular apex.

Trial registration: ClinicalTrials.gov NCT00530894.

Keywords: learning curve; safety; success; technical performance; transapical transcatheter aortic valve replacement.

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Conflict of interest statement

Statement R.M.S. is a member of the Clinical Steering Committee at Abbott and S.J.M., consults with Sorin and Abbott, has a patent application with Sorin, and does research with Sorin, Edwards Lifesciences, Abbott, and St Jude; A.D.P. is a proctor for Edwards Lifesciences; M.M. is a member of the executive committee for Edward Lifesciences’ PARTNER trial; L.G.S. is on executive committees for Edwards Lifesciences’ PARTNER and COMMENCE trials; V.H.T. consults with Edwards Lifesciences; R.M. has research support from Edwards Lifesciences and St Jude Medical, consults with Abbott Vascular, Cordis, and Medtronic, and has equity in Entourage Medical; E.H.B. is on executive committees for Edwards Lifesciences’ PARTNER and COMMENCE trials and leads the Cleveland Clinic PARTNER Publications Office, which carries out and publishes independent analyses of PARTNER data. All other authors have nothing to disclose with regard to commercial support.

Figures

FIGURE 1
FIGURE 1
Overall profile of procedure time and device success for transapical transcatheter aortic valve replacement, ordered by institution-specific patient sequence number. Solid red line represents average procedure time adjusted for institution and solid blue line represents average percent of patients who experienced successful device deployment.
FIGURE 2
FIGURE 2
Overall profile of mean technical performance for transapical transcatheter aortic valve replacement, ordered by institution-specific patient sequence number. Solid line represents average profiles adjusted for institution, enclosed within a dashed 68% confidence band equivalent to 1 standard error. For crude verification of model fit, symbols in (A) through (C) are mean responses of data unadjusted for institution grouped into deciles by patient sequence number, and dotted curves in (D) are profiles for each institution. A, Procedure time (minutes). B, Total fluoroscopy time (minutes). C, Contrast volume (mL). D, Number of postdilatations.
FIGURE 3
FIGURE 3
Profile of percentage of patients who experienced successful device deployment during transapical transcatheter aortic valve replacement, ordered by institution-specific patient sequence number. Format is as in Figure 2.
FIGURE 4
FIGURE 4
Patients who experienced an adverse event during or after transapical transcatheter aortic valve replacement, ordered by institution-specific patient sequence number. Format is as in Figure 2. A, Adverse events during procedure. B, Major adverse events within 30 days.
FIGURE 5
FIGURE 5
Length of hospital stay after transapical transcatheter aortic valve replacement, ordered by institution-specific patient sequence number. Format is as in Figure 2.
FIGURE 6
FIGURE 6
Percentage of patients in each paravalvular aortic regurgitation (AR) grade at discharge, ordered by institution-specific patient sequence number. Format is as in Figure 2.
FIGURE 7
FIGURE 7
Association between procedure time and major adverse events within 30 days after transapical transcatheter aortic valve replacement. Solid line represents average profiles adjusted for institution, enclosed within a dashed 68% confidence band equivalent to 1 standard error.
VIDEO 1
VIDEO 1
Transapical transcatheter aortic valve replacement procedure using an Edwards SAPIEN S3 valve. Video available at http://www.jtcvsonline.org/article/S0022-5223(16)30099-X/addons.
See this image and copyright information in PMC

Comment in

  • Navigating the s-curve of transapical therapy.
    Alkhouli MA, Raybuck BD, Badhwar V. Alkhouli MA, et al. J Thorac Cardiovasc Surg. 2016 Sep;152(3):781-2. doi: 10.1016/j.jtcvs.2016.06.055. Epub 2016 Jul 15. J Thorac Cardiovasc Surg. 2016. PMID: 27530638 No abstract available.

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