title: Learning curves for transapical transcatheter aortic valve replacement in the PARTNER-I trial: Technical performance, success, and safety.
abstract: 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).
  
  
  
  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.
  
  
  
  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).
  
  
  
  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.
authors.affiliation: Cleveland Clinic, Cleveland, Ohio. Electronic address: surir@ccf.org.
authors.forename: Rakesh M
authors.initials: RM
authors.lastname: Suri
authors.affiliation: Assaf-Harofeh Medical Center, Zerifin, Israel.
authors.forename: Sa'ar
authors.initials: S
authors.lastname: Minha
authors.affiliation: University of Alabama, Birmingham, Ala.
authors.forename: Oluseun
authors.initials: O
authors.lastname: Alli
authors.affiliation: MedStar Washington Hospital Center, Washington, DC.
authors.forename: Ron
authors.initials: R
authors.lastname: Waksman
authors.affiliation: Mayo Clinic, Rochester, Minn.
authors.forename: Charanjit S
authors.initials: CS
authors.lastname: Rihal
authors.affiliation: MedStar Washington Hospital Center, Washington, DC.
authors.forename: Lowell P
authors.initials: LP
authors.lastname: Satler
authors.affiliation: Mayo Clinic, Rochester, Minn.
authors.forename: Kevin L
authors.initials: KL
authors.lastname: Greason
authors.affiliation: MedStar Washington Hospital Center, Washington, DC.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Torguson
authors.affiliation: MedStar Washington Hospital Center, Washington, DC.
authors.forename: Augusto D
authors.initials: AD
authors.lastname: Pichard
authors.affiliation: Baylor Scott & White Health, Plano, Tex.
authors.forename: Michael
authors.initials: M
authors.lastname: Mack
authors.affiliation: Cleveland Clinic, Cleveland, Ohio.
authors.forename: Lars G
authors.initials: LG
authors.lastname: Svensson
authors.affiliation: Cleveland Clinic, Cleveland, Ohio.
authors.forename: Jeevanantham
authors.initials: J
authors.lastname: Rajeswaran
authors.affiliation: Cleveland Clinic, Cleveland, Ohio.
authors.forename: Ashley M
authors.initials: AM
authors.lastname: Lowry
authors.affiliation: Cleveland Clinic, Cleveland, Ohio.
authors.forename: John
authors.initials: J
authors.lastname: Ehrlinger
authors.affiliation: Cleveland Clinic, Cleveland, Ohio.
authors.forename: Stephanie L
authors.initials: SL
authors.lastname: Mick
authors.affiliation: Cleveland Clinic, Cleveland, Ohio.
authors.forename: E Murat
authors.initials: EM
authors.lastname: Tuzcu
authors.affiliation: Emory University School of Medicine, Atlanta, Ga.
authors.forename: Vinod H
authors.initials: VH
authors.lastname: Thourani
authors.affiliation: Cedars Sinai Medical Center, Los Angeles, Calif.
authors.forename: Raj
authors.initials: R
authors.lastname: Makkar
authors.affiliation: Mayo Clinic, Rochester, Minn.
authors.forename: David
authors.initials: D
authors.lastname: Holmes
authors.affiliation: Columbia University Medical Center/New York-Presbyterian Hospital, New York, NY.
authors.forename: Martin B
authors.initials: MB
authors.lastname: Leon
authors.affiliation: Cleveland Clinic, Cleveland, Ohio.
authors.forename: Eugene H
authors.initials: EH
authors.lastname: Blackstone
mesh_terms: D000369:Aged, 80 and over; D001024:Aortic Valve Stenosis / Q000601:surgery*; D002983:Clinical Competence; D005260:Female; D006801:Humans; D059032:Learning Curve; D008297:Male; D061646:Operative Time; D061214:Patient Safety; D011183:Postoperative Complications; D065467:Transcatheter Aortic Valve Replacement / Q000193:education* / Q000379:methods*; D016896:Treatment Outcome
keywords: learning curve; safety; success; technical performance; transapical transcatheter aortic valve replacement