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One-year multicentre outcomes of transapical aortic valve implantation using the SAPIEN XT™ valve: the PREVAIL transapical study

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One-year multicentre outcomes of transapical aortic valve implantation using the SAPIEN XT™ valve: the PREVAIL transapical study. / Walther, Thomas; Thielmann, Matthias; Kempfert, Joerg; Schroefel, Holger; Wimmer-Greinecker, Gerhard; Treede, Hendrik; Wahlers, Thorsten; Wendler, Olaf.

In: EUR J CARDIO-THORAC, Vol. 43, No. 5, 05.2013, p. 986-992.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Walther, T, Thielmann, M, Kempfert, J, Schroefel, H, Wimmer-Greinecker, G, Treede, H, Wahlers, T & Wendler, O 2013, 'One-year multicentre outcomes of transapical aortic valve implantation using the SAPIEN XT™ valve: the PREVAIL transapical study', EUR J CARDIO-THORAC, vol. 43, no. 5, pp. 986-992. https://doi.org/10.1093/ejcts/ezs589

APA

Walther, T., Thielmann, M., Kempfert, J., Schroefel, H., Wimmer-Greinecker, G., Treede, H., Wahlers, T., & Wendler, O. (2013). One-year multicentre outcomes of transapical aortic valve implantation using the SAPIEN XT™ valve: the PREVAIL transapical study. EUR J CARDIO-THORAC, 43(5), 986-992. https://doi.org/10.1093/ejcts/ezs589

Vancouver

Walther T, Thielmann M, Kempfert J, Schroefel H, Wimmer-Greinecker G, Treede H et al. One-year multicentre outcomes of transapical aortic valve implantation using the SAPIEN XT™ valve: the PREVAIL transapical study. EUR J CARDIO-THORAC. 2013 May;43(5):986-992. https://doi.org/10.1093/ejcts/ezs589

Bibtex

@article{97c1acf792c148a8a1b2646cb0e943fe,
title = "One-year multicentre outcomes of transapical aortic valve implantation using the SAPIEN XT{\texttrademark} valve: the PREVAIL transapical study",
abstract = "OBJECTIVES: The study aimed to evaluate 1-year outcomes of the multicentre PREVAIL transapical (TA) study of TA-aortic valve implantation (AVI) in high-risk patients.METHODS: From September 2009 to August 2010, a total of 150 patients, aged 81.6 ± 5.8 years, 40.7% female, were included at 12 European TA-AVI experienced sites. Patients received 23 (n = 36), 26 (n = 57) and 29 mm (n = 57) second-generation SAPIEN XT{\texttrademark} (Edwards Lifesciences, Irvine, CA, USA) valves. The mean logistic EuroSCORE was 24.3 ± 7.0, and mean Society Thoracic Surgeons score was 7.5 ± 4.4%.RESULTS: Survival was 91.3% at 30 days and 77.9% at 1 year. Subgroup analysis revealed survivals of 91.7/88.9, 86.0/70.2, 96.55/91.2% for patients receiving 23-, 26- and 29-mm valves at 30 days and at 1 year, respectively. Transthoracic echocardiography revealed preserved left ventricular ejection fraction and low gradients. Aortic incompetence was none in 41/48, trace 30/36, mild 22/12 and moderate in 7/4% at discharge and 1 year. Walking distance increased from 221 (postimplant) to 284 m (at 1 year, P = 0.0004). Three patients required reoperation due to increasing aortic incompetence during follow-up. Causes of mortality at 1 year were cardiac (n = 7), stroke (n = 1) and others (n = 5).CONCLUSIONS: The European PREVAIL multicentre trial demonstrates good functionality and good outcomes for TA-AVI using the second-generation SAPIEN XT prosthesis and the ASCENDRA-II delivery system. The 29-mm SAPIEN XT valve was successfully introduced and showed excellent results.",
keywords = "Aged, Aged, 80 and over, Aortic Valve/surgery, Aortic Valve Insufficiency/diagnostic imaging, Aortic Valve Stenosis/surgery, Echocardiography, Female, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation/adverse effects, Humans, Kaplan-Meier Estimate, Male, Treatment Outcome",
author = "Thomas Walther and Matthias Thielmann and Joerg Kempfert and Holger Schroefel and Gerhard Wimmer-Greinecker and Hendrik Treede and Thorsten Wahlers and Olaf Wendler",
year = "2013",
month = may,
doi = "10.1093/ejcts/ezs589",
language = "English",
volume = "43",
pages = "986--992",
journal = "EUR J CARDIO-THORAC",
issn = "1010-7940",
publisher = "Elsevier",
number = "5",

}

RIS

TY - JOUR

T1 - One-year multicentre outcomes of transapical aortic valve implantation using the SAPIEN XT™ valve: the PREVAIL transapical study

AU - Walther, Thomas

AU - Thielmann, Matthias

AU - Kempfert, Joerg

AU - Schroefel, Holger

AU - Wimmer-Greinecker, Gerhard

AU - Treede, Hendrik

AU - Wahlers, Thorsten

AU - Wendler, Olaf

PY - 2013/5

Y1 - 2013/5

N2 - OBJECTIVES: The study aimed to evaluate 1-year outcomes of the multicentre PREVAIL transapical (TA) study of TA-aortic valve implantation (AVI) in high-risk patients.METHODS: From September 2009 to August 2010, a total of 150 patients, aged 81.6 ± 5.8 years, 40.7% female, were included at 12 European TA-AVI experienced sites. Patients received 23 (n = 36), 26 (n = 57) and 29 mm (n = 57) second-generation SAPIEN XT™ (Edwards Lifesciences, Irvine, CA, USA) valves. The mean logistic EuroSCORE was 24.3 ± 7.0, and mean Society Thoracic Surgeons score was 7.5 ± 4.4%.RESULTS: Survival was 91.3% at 30 days and 77.9% at 1 year. Subgroup analysis revealed survivals of 91.7/88.9, 86.0/70.2, 96.55/91.2% for patients receiving 23-, 26- and 29-mm valves at 30 days and at 1 year, respectively. Transthoracic echocardiography revealed preserved left ventricular ejection fraction and low gradients. Aortic incompetence was none in 41/48, trace 30/36, mild 22/12 and moderate in 7/4% at discharge and 1 year. Walking distance increased from 221 (postimplant) to 284 m (at 1 year, P = 0.0004). Three patients required reoperation due to increasing aortic incompetence during follow-up. Causes of mortality at 1 year were cardiac (n = 7), stroke (n = 1) and others (n = 5).CONCLUSIONS: The European PREVAIL multicentre trial demonstrates good functionality and good outcomes for TA-AVI using the second-generation SAPIEN XT prosthesis and the ASCENDRA-II delivery system. The 29-mm SAPIEN XT valve was successfully introduced and showed excellent results.

AB - OBJECTIVES: The study aimed to evaluate 1-year outcomes of the multicentre PREVAIL transapical (TA) study of TA-aortic valve implantation (AVI) in high-risk patients.METHODS: From September 2009 to August 2010, a total of 150 patients, aged 81.6 ± 5.8 years, 40.7% female, were included at 12 European TA-AVI experienced sites. Patients received 23 (n = 36), 26 (n = 57) and 29 mm (n = 57) second-generation SAPIEN XT™ (Edwards Lifesciences, Irvine, CA, USA) valves. The mean logistic EuroSCORE was 24.3 ± 7.0, and mean Society Thoracic Surgeons score was 7.5 ± 4.4%.RESULTS: Survival was 91.3% at 30 days and 77.9% at 1 year. Subgroup analysis revealed survivals of 91.7/88.9, 86.0/70.2, 96.55/91.2% for patients receiving 23-, 26- and 29-mm valves at 30 days and at 1 year, respectively. Transthoracic echocardiography revealed preserved left ventricular ejection fraction and low gradients. Aortic incompetence was none in 41/48, trace 30/36, mild 22/12 and moderate in 7/4% at discharge and 1 year. Walking distance increased from 221 (postimplant) to 284 m (at 1 year, P = 0.0004). Three patients required reoperation due to increasing aortic incompetence during follow-up. Causes of mortality at 1 year were cardiac (n = 7), stroke (n = 1) and others (n = 5).CONCLUSIONS: The European PREVAIL multicentre trial demonstrates good functionality and good outcomes for TA-AVI using the second-generation SAPIEN XT prosthesis and the ASCENDRA-II delivery system. The 29-mm SAPIEN XT valve was successfully introduced and showed excellent results.

KW - Aged

KW - Aged, 80 and over

KW - Aortic Valve/surgery

KW - Aortic Valve Insufficiency/diagnostic imaging

KW - Aortic Valve Stenosis/surgery

KW - Echocardiography

KW - Female

KW - Heart Valve Prosthesis

KW - Heart Valve Prosthesis Implantation/adverse effects

KW - Humans

KW - Kaplan-Meier Estimate

KW - Male

KW - Treatment Outcome

U2 - 10.1093/ejcts/ezs589

DO - 10.1093/ejcts/ezs589

M3 - SCORING: Journal article

C2 - 23345186

VL - 43

SP - 986

EP - 992

JO - EUR J CARDIO-THORAC

JF - EUR J CARDIO-THORAC

SN - 1010-7940

IS - 5

ER -