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

• Published in: The Journal of thoracic and cardiovascular surgery Vol. 152; no. 3; pp. 773 - 780.e14
• Main Authors: Suri, Rakesh M., MD, DPhil, Minha, Sa'ar, MD, Alli, Oluseun, MD, Waksman, Ron, MD, Rihal, Charanjit S., MD, Satler, Lowell P., MD, Greason, Kevin L., MD, Torguson, Rebecca, MPH, Pichard, Augusto D., MD, Mack, Michael, MD, Svensson, Lars G., MD, PhD, Rajeswaran, Jeevanantham, PhD, Lowry, Ashley M., MS, Ehrlinger, John, PhD, Mick, Stephanie L., MD, Tuzcu, E. Murat, MD, Thourani, Vinod H., MD, Makkar, Raj, MD, Holmes, David, MD, Leon, Martin B., MD, Blackstone, Eugene H., MD
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.09.2016
• Subjects: Aged, 80 and over; Aortic Valve Stenosis - surgery; Cardiothoracic Surgery; Clinical Competence; Female; Humans; Learning Curve; Male; Operative Time; Patient Safety; Postoperative Complications; safety; success; technical performance; transapical transcatheter aortic valve replacement; Transcatheter Aortic Valve Replacement - education; Transcatheter Aortic Valve Replacement - methods; Treatment Outcome; PARTNER; Placement of Aortic Transcatheter Valves; TA; technical performance; transapical; TAVR; AR; TF; aortic regurgitation; transapical transcatheter aortic valve replacement; success; safety; transfemoral; transcatheter aortic valve replacement; learning curve
• ISSN: 0022-5223; 1097-685X
• DOI: 10.1016/j.jtcvs.2016.04.028

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.