Clinical and hemodynamic outcomes of “all-comers” undergoing transapical aortic valve implantation: Results from the Italian Registry of Trans-Apical Aortic Valve Implantation (I-TA)

• Published in: The Journal of thoracic and cardiovascular surgery Vol. 142; no. 4; pp. 768 - 775
• Main Authors: D’Onofrio, Augusto, MD, Rubino, Paolo, MD, Fusari, Melissa, MD, Salvador, Loris, MD, Musumeci, Francesco, MD, Rinaldi, Mauro, MD, Vitali, Ettore O., MD, Glauber, Mattia, MD, Di Bartolomeo, Roberto, MD, Alfieri, Ottavio R., MD, Polesel, Elvio, MD, Aiello, Marco, MD, Casabona, Riccardo, MD, Livi, Ugolino, MD, Grossi, Claudio, MD, Cassese, Mauro, MD, Pappalardo, Aniello, MD, Gherli, Tiziano, MD, Stefanelli, Guglielmo, MD, Faggian, Giuseppe G., MD, Gerosa, Gino, MD
• Format: Journal Article
• Language: English
• Published: New York, NY Mosby, Inc 01.10.2011; Elsevier
• Subjects: Aged; Aged, 80 and over; Anesthesia. Intensive care medicine. Transfusions. Cell therapy and gene therapy; Aortic valve; Aortic Valve - physiopathology; Aortic Valve - surgery; Aortic Valve Stenosis - mortality; Aortic Valve Stenosis - physiopathology; Aortic Valve Stenosis - surgery; Biological and medical sciences; Cardiac Catheterization - adverse effects; Cardiac Catheterization - instrumentation; Cardiac Catheterization - mortality; Cardiology. Vascular system; Cardiothoracic Surgery; Chi-Square Distribution; Creatinine; Female; Heart; Heart Valve Prosthesis; Heart Valve Prosthesis Implantation - adverse effects; Heart Valve Prosthesis Implantation - instrumentation; Heart Valve Prosthesis Implantation - methods; Heart Valve Prosthesis Implantation - mortality; Hemodynamics; Hospitals; Humans; Italy; Kaplan-Meier Estimate; Learning; Learning Curve; Logistic Models; Male; Medical sciences; Mortality; Odds Ratio; Pneumology; Prospective Studies; Registries; Risk Assessment; Risk Factors; Surgery; Survival; Survival Rate; Thorax; Time Factors; Treatment Outcome; Italy; TF-TAVI; MPG; PPG; TAVI; odds ratio; severe symptomatic aortic valve stenosis; New York Heart Association; STS; transfemoral transcatheter aortic valve implantation; TA-TAVI; Society of Thoracic Surgeons; NYHA; transcatheter aortic valve implantation; transapical transcatheter aortic valve implantation; OR; CI; SSAVS; 35.3.5; SAVR; 35.2; mean transvalvular pressure gradient; peak transvalvular pressure gradient; confidence intervals; Italian Registry of Trans-Apical Aortic Valve Implantation; surgical aortic valve replacement; I-TA registry; Italian; Prognosis; Anesthesia; Implantation; Circulatory system; Hemodynamics; Cardiology; Aortic valve; Result
• ISSN: 0022-5223; 1097-685X
• DOI: 10.1016/j.jtcvs.2011.06.026

Objective The aim of this study was to assess clinical and hemodynamic outcomes of transapical aortic valve implantation (TA-TAVI) in patients enrolled in the Italian Registry of Trans-Apical Aortic Valve Implantation (I-TA). Methods From April 2008 until November 2010, 504 patients from 20 Italian centers were enrolled in the I-TA registry. Mean logistic EuroSCORE and Society of Thoracic Surgeons score were 24% ± 16% and 11% ± 4%, respectively. Mean follow-up was 9.2 ± 6.5 months (range, 1-26 months). Outcomes were analyzed according to intraoperative complications, procedural volume (high-volume centers, >20 cases; low-volume centers, < 20 cases) and learning curve (first 50% cases vs second 50% cases of each center). Results All-cause overall mortality was 8.3% (42 patients). Device success was 99% (500/504 patients). Intraoperative severe complications occurred in 24 (4.8%) patients. Overall 2-year survival was 71.5% ± 6.2%. At discharge, peak and mean gradients were 16.4 ± 11.2 and 8.7 ± 4.1 mm Hg, respectively, and effective orifice area was 1.67 cm2 . These values remained stable at 3, 6, and 12 months after surgery. Independent risk factors for mortality after TA-TAVI were as follows: New York Heart Association class III and IV (odds ratio [OR], 4.43; 95% confidence intervals [CI], 1.28-15.40; P  = .02); logistic EuroSCORE greater than 20 (OR, 1.83; 95% CI, 1.02-3.29; P  = .04); creatinine concentration greater than 200 μmol/L (OR, 2.56; 95% CI, 1.07-6.15; P  = .03), and intraoperative complications (OR, 5.80; 95% CI, 2.68-12.55; P  < .001). There were no significant differences in outcomes between high- and low-volume centers and between the first and the second 50% of cases. Conclusions TA-TAVI represents a safe and effective alternative treatment for patients who are inoperable or at high risk for surgery. The occurrence of an intraoperative complication significantly affects survival. Procedural volume and learning curve have no impact on patient survival.