Key result
Transapical aortic valve implantation using the 29-mm Edwards SAPIEN XT bioprosthesis in patients with a large aortic annulus achieved a 95.8% procedural success rate and 95.8% 30-day survival.
Why the study?
Does transapical aortic valve implantation using a 29-mm Edwards SAPIEN XT bioprosthesis achieve procedural success and acceptable survival in high-risk elderly patients with a large aortic annulus?
Observational (n=120)
Yes
Does transapical aortic valve implantation using a 29-mm Edwards SAPIEN XT bioprosthesis achieve procedural success and acceptable survival in high-risk elderly patients with a large aortic annulus?
The 29-mm Edwards SAPIEN XT bioprosthesis demonstrates high procedural success and acceptable 1-year survival in high-risk elderly patients with a large aortic annulus undergoing transapical TAVI.
Answers are grounded in this paper and cite their sources.
May support TAVI feasibility in large annuli; leaves open need for randomized comparisons on durability and outcomes.
OBJECTIVES: The feasibility of transcatheter aortic valve implantation is limited by the diameter of the aortic annulus. Patients with an annulus of >25 mm were previously unsuitable for transcatheter valve implantation using the Edwards SAPIEN™ bioprosthesis. The 29-mm Edwards SAPIEN XT™ bioprosthesis is a new device suitable for transapical aortic valve implantation in patients with a large aortic annulus. We report the worldwide experience in using this device. METHODS: A total of 120 patients (age 80.3 ± 5.7 years, 2.5% female) underwent transapical aortic valve implantation using a 29-mm Edwards SAPIEN XT™ bioprosthesis between the period of December 2009 and February 2011. The mean values of the logistic EuroSCORE and the STS score were 23.4 ± 7.7 and 6.8 ± 4.0, respectively. A total of 20 centres participated in this study and all patients gave written informed consent. RESULTS: There were two conversions to open heart surgery (1.7%) and four patients (3.3%) required a temporary cardiopulmonary bypass support. A mean of 131 ± 68.0-ml contrast dye was used. The procedural success, defined as one valve implanted, no aortic regurgitation (AR) >2+ and a transcatheter valve in the appropriate position, was achieved in 95.8% of patients. Early postoperative complications at ≤ 30 days included renal failure requiring temporary dialysis (n = 7, 5.8%), reopening for bleeding (n = 5, 4.2%), stroke (n = 2, 1.7%), respiratory complications requiring prolonged mechanical ventilation (n = 11, 9.2%) and postoperative pacemaker implantation (n = 15/12.5%). The Kaplan-Meier survival estimates were 95.8% at 30-day, 88.9% at 6-month and 79.8% at the 1-year follow-up. The controlled echocardiography data at 30 days (n = 95) revealed no/trivial AR in 79 (84.1%), mild AR in 12 (12.8%) and moderate in two (2.2%) patients. The univariable analysis of baseline characteristics revealed no predictor for 30-day mortality. CONCLUSIONS: The 29-mm Edwards SAPIEN XT™ bioprosthesis provides an excellent outcome in patients with a large aortic annulus undergoing transapical aortic valve implantation. Using this larger transcatheter heart valve, a broader population of high-risk elderly patients with aortic stenosis can be treated by minimally invasive transapical implantation techniques.
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Wendler et al. (2012) conducted an observational in Aortic stenosis with large aortic annulus (n=120). 29-mm Edwards SAPIEN XT bioprosthesis was evaluated on Procedural success (one valve implanted, no AR >2+, appropriate position). Transapical aortic valve implantation using the 29-mm Edwards SAPIEN XT bioprosthesis in patients with a large aortic annulus achieved a 95.8% procedural success rate and 95.8% 30-day survival.
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