Worldwide experience with the 29-mm Edwards SAPIEN XT™ transcatheter heart valve in patients with large aortic annulus

TY - JOUR

T1 - Worldwide experience with the 29-mm Edwards SAPIEN XT™ transcatheter heart valve in patients with large aortic annulus

AU - Wendler, Olaf

AU - Thielmann, Matthias

AU - Schroefel, Holger

AU - Rastan, Ardawan

AU - Treede, Hendrik

AU - Wahlers, Thorsten

AU - Eichinger, Walther

AU - Walther, Thomas

PY - 2013/2

Y1 - 2013/2

N2 - 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.

AB - 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.

KW - Aged, 80 and over

KW - Aortic Valve/abnormalities

KW - Aortic Valve Stenosis/surgery

KW - Bioprosthesis

KW - Cardiac Catheterization/methods

KW - Conversion to Open Surgery

KW - Female

KW - Heart Valve Prosthesis

KW - Heart Valve Prosthesis Implantation/methods

KW - Humans

KW - Male

KW - Operative Time

KW - Postoperative Complications/etiology

KW - Treatment Outcome

U2 - 10.1093/ejcts/ezs203

DO - 10.1093/ejcts/ezs203

M3 - SCORING: Journal article

C2 - 22522982

VL - 43

SP - 371

EP - 377

JO - EUR J CARDIO-THORAC

JF - EUR J CARDIO-THORAC

SN - 1010-7940

IS - 2

ER -