Transapical transcatheter aortic valve implantation: Follow-up to 3 years

• Published in: The Journal of thoracic and cardiovascular surgery Vol. 139; no. 5; pp. 1107 - 1113.e1
• Main Authors: Ye, Jian, MD, Cheung, Anson, MD, Lichtenstein, Samuel V., MD, PhD, Nietlispach, Fabian, MD, Albugami, Saad, MD, Masson, Jean-Bernard, MD, Thompson, Christopher R., MD, Munt, Brad, MD, Moss, Robert, MD, Carere, Ronald G., MD, Jamieson, W. R. Eric, MD, Webb, John G., MD
• Format: Journal Article
• Language: English
• Published: United States Mosby, Inc 01.05.2010
• Subjects: Aged; Aged, 80 and over; Aortic Valve - diagnostic imaging; Aortic Valve - physiopathology; Aortic Valve Stenosis - diagnostic imaging; Aortic Valve Stenosis - mortality; Aortic Valve Stenosis - physiopathology; Aortic Valve Stenosis - therapy; Bioprosthesis; Cardiac Catheterization - adverse effects; Cardiac Catheterization - instrumentation; Cardiac Catheterization - mortality; Cardiothoracic Surgery; Female; Follow-Up Studies; 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; Humans; Kaplan-Meier Estimate; Logistic Models; Male; Patient Selection; Prosthesis Design; Recovery of Function; Risk Assessment; Severity of Illness Index; Time Factors; Treatment Outcome; Ultrasonography; NYHA; New York Heart Association; 35; STS; AVI; aortic valve replacement; CPB; 28; cardiopulmonary bypass; aortic valve implantation; The Society of Thoracic Surgeons; AVR
• ISSN: 0022-5223; 1097-685X
• DOI: 10.1016/j.jtcvs.2009.10.056

Background We performed the first human case of successful transapical transcatheter aortic valve implantation on a beating heart in October 2005, and therefore we have the longest follow-up on transapical aortic valve implantation in humans. We now report clinical and echocardiographic outcomes of transapical aortic valve implantation in 71 patients. Methods Between October 2005 and February 2009, 71 patients (44 female) underwent transcatheter transapical aortic valve implantation with either 23- or 26-mm Edwards Lifesciences transcatheter bioprostheses. All patients with symptomatic aortic stenosis were declined for conventional aortic valve replacement owing to unacceptable operative risks and were not candidates for transfemoral aortic valve implantation because of poor arterial access. Clinical and echocardiographic follow-ups were performed before discharge, at 1 and 6 months, and then yearly. The mean follow-up was 12.9 ± 11.5 months with a total of 917.3 months of follow-up. Results Mean age was 80.0 ± 8.1 years and predicted operative mortality was 34.5% ± 20.4% by logistic EuroSCORE and 12.1% ± 7.7% by The Society of Thoracic Surgeons Risk Calculator. Valves were successfully implanted in all patients. Twelve patients died within 30 days (30-day mortality: 16.9% in all patients, 33% in the first 15 patients, and 12.5% in the remainder), and 10 patients died subsequently. Overall survival at 24 and 36 months was 66.3% ± 6.4% and 58.0% ± 9.5%, respectively. Among 59 patients who survived at least 30 days, 24- and 36-month survivals were 79.8% ± 6.4% and 69.8% ± 10.9%, respectively. Late valve-related complications were rare. New York Heart Association functional class improved significantly from preoperative 3.3 ± 0.8 to 1.8 ± 0.8 at 24 months. The aortic valve area and mean gradient remained stable at 24 months (1.6 ± 0.3 cm2 and 10.3 ± 5.9 mm Hg, respectively). Conclusion Our outcome suggests that transapical transcatheter aortic valve implantation provides sustained clinical and hemodynamic benefits for up to 36 months in selected high-risk patients with symptomatic severe aortic stenosis.