Worldwide experience with the 29-mm Edwards SAPIEN XT™ transcatheter heart valve in patients with large aortic annulus
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Worldwide experience with the 29-mm Edwards SAPIEN XT™ transcatheter heart valve in patients with large aortic annulus. / Wendler, Olaf; Thielmann, Matthias; Schroefel, Holger; Rastan, Ardawan; Treede, Hendrik; Wahlers, Thorsten; Eichinger, Walther; Walther, Thomas.
in: EUR J CARDIO-THORAC, Jahrgang 43, Nr. 2, 02.2013, S. 371-377.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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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 -