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Transapical aortic valve implantation using a new self-expandable bioprosthesis (ACURATE TA™): 6-month outcomes

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Transapical aortic valve implantation using a new self-expandable bioprosthesis (ACURATE TA™): 6-month outcomes. / Kempfert, Jörg; Treede, Hendrik; Rastan, Ardawan J; Schönburg, Markus; Thielmann, Matthias; Sorg, Stefan; Mohr, Friedrich-W; Walther, Thomas.

In: EUR J CARDIO-THORAC, Vol. 43, No. 1, 01.2013, p. 52-56.

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

Harvard

Kempfert, J, Treede, H, Rastan, AJ, Schönburg, M, Thielmann, M, Sorg, S, Mohr, F-W & Walther, T 2013, 'Transapical aortic valve implantation using a new self-expandable bioprosthesis (ACURATE TA™): 6-month outcomes', EUR J CARDIO-THORAC, vol. 43, no. 1, pp. 52-56. https://doi.org/10.1093/ejcts/ezs139

APA

Kempfert, J., Treede, H., Rastan, A. J., Schönburg, M., Thielmann, M., Sorg, S., Mohr, F-W., & Walther, T. (2013). Transapical aortic valve implantation using a new self-expandable bioprosthesis (ACURATE TA™): 6-month outcomes. EUR J CARDIO-THORAC, 43(1), 52-56. https://doi.org/10.1093/ejcts/ezs139

Vancouver

Kempfert J, Treede H, Rastan AJ, Schönburg M, Thielmann M, Sorg S et al. Transapical aortic valve implantation using a new self-expandable bioprosthesis (ACURATE TA™): 6-month outcomes. EUR J CARDIO-THORAC. 2013 Jan;43(1):52-56. https://doi.org/10.1093/ejcts/ezs139

Bibtex

@article{e674604aa84d4b0bae84a640b63af616,
title = "Transapical aortic valve implantation using a new self-expandable bioprosthesis (ACURATE TA{\texttrademark}): 6-month outcomes",
abstract = "OBJECTIVES: The ACURATE TA({\texttrademark}) Aortic Bioprosthesis and Delivery System (Symetis S.A., Ecublens, Switzerland) is a new transcatheter aortic valve designed for transapical implantation. The six-month results from the completed first-in-man study are reported.METHODS: The Symetis ACURATE TA({\texttrademark}) is composed of a porcine biological tissue valve attached to a self-expandable nitinol stent. It allows for anatomical orientation and facilitates intuitive implantation providing tactile feedback. Since November 2009, a total of 40 high-risk elderly patients have been treated.RESULTS: The mean age of enrolled patients was 83.2 ± 4.0; 60.0% were female, with a mean logistic EuroSCORE of 21.2 ± 10.8% and a mean Society of Thoracic Surgeons (STS) score of 9.0 ± 4.7%. All implants were delivered successfully in the intra-annular and subcoronary position. One patient was converted to conventional surgery due to coronary impingement (after valve-in-valve implantation). One additional patient received valve-in-valve treatment (SAPIEN THV TA({\texttrademark})). Five patients expired within 30 days and two additional patients expired during the 6-month follow-up due to non-valve-related causes resulting in a mid-term survival rate of 82.5%. Two patients suffered a stroke and another three required new onset pacemaker implantation. The mean aortic gradient significantly improved and remained stable throughout the follow-up (baseline: 51.9 ± 14.3 mmHg, 30 days: 12.3 ± 5.1 mmHg, 6 months: 11.9 ± 5.8 mmHg). At the 6-month follow-up, 96.7% of patients demonstrated either none/trace or mild (1+/4) paravalvular leakage only. According to the Valve Academic Research Council the device's success rate was 92.5%, with a 30-day safety profile of 25%.CONCLUSIONS: At the 6-month follow-up, the ACURATE TA({\texttrademark}) device showed stable valve function with low rates of paravalvular leakages. The cohort of high-risk patients demonstrated good clinical outcomes and 6-month survival.",
keywords = "Aged, Aged, 80 and over, Aortic Valve/surgery, Cause of Death, Female, Heart Valve Diseases/surgery, Heart Valve Prosthesis, Heart Valve Prosthesis Implantation/instrumentation, Humans, Kaplan-Meier Estimate, Male, Minimally Invasive Surgical Procedures/instrumentation, Prospective Studies, Survival Rate, Treatment Outcome",
author = "J{\"o}rg Kempfert and Hendrik Treede and Rastan, {Ardawan J} and Markus Sch{\"o}nburg and Matthias Thielmann and Stefan Sorg and Friedrich-W Mohr and Thomas Walther",
year = "2013",
month = jan,
doi = "10.1093/ejcts/ezs139",
language = "English",
volume = "43",
pages = "52--56",
journal = "EUR J CARDIO-THORAC",
issn = "1010-7940",
publisher = "Elsevier",
number = "1",

}

RIS

TY - JOUR

T1 - Transapical aortic valve implantation using a new self-expandable bioprosthesis (ACURATE TA™): 6-month outcomes

AU - Kempfert, Jörg

AU - Treede, Hendrik

AU - Rastan, Ardawan J

AU - Schönburg, Markus

AU - Thielmann, Matthias

AU - Sorg, Stefan

AU - Mohr, Friedrich-W

AU - Walther, Thomas

PY - 2013/1

Y1 - 2013/1

N2 - OBJECTIVES: The ACURATE TA(™) Aortic Bioprosthesis and Delivery System (Symetis S.A., Ecublens, Switzerland) is a new transcatheter aortic valve designed for transapical implantation. The six-month results from the completed first-in-man study are reported.METHODS: The Symetis ACURATE TA(™) is composed of a porcine biological tissue valve attached to a self-expandable nitinol stent. It allows for anatomical orientation and facilitates intuitive implantation providing tactile feedback. Since November 2009, a total of 40 high-risk elderly patients have been treated.RESULTS: The mean age of enrolled patients was 83.2 ± 4.0; 60.0% were female, with a mean logistic EuroSCORE of 21.2 ± 10.8% and a mean Society of Thoracic Surgeons (STS) score of 9.0 ± 4.7%. All implants were delivered successfully in the intra-annular and subcoronary position. One patient was converted to conventional surgery due to coronary impingement (after valve-in-valve implantation). One additional patient received valve-in-valve treatment (SAPIEN THV TA(™)). Five patients expired within 30 days and two additional patients expired during the 6-month follow-up due to non-valve-related causes resulting in a mid-term survival rate of 82.5%. Two patients suffered a stroke and another three required new onset pacemaker implantation. The mean aortic gradient significantly improved and remained stable throughout the follow-up (baseline: 51.9 ± 14.3 mmHg, 30 days: 12.3 ± 5.1 mmHg, 6 months: 11.9 ± 5.8 mmHg). At the 6-month follow-up, 96.7% of patients demonstrated either none/trace or mild (1+/4) paravalvular leakage only. According to the Valve Academic Research Council the device's success rate was 92.5%, with a 30-day safety profile of 25%.CONCLUSIONS: At the 6-month follow-up, the ACURATE TA(™) device showed stable valve function with low rates of paravalvular leakages. The cohort of high-risk patients demonstrated good clinical outcomes and 6-month survival.

AB - OBJECTIVES: The ACURATE TA(™) Aortic Bioprosthesis and Delivery System (Symetis S.A., Ecublens, Switzerland) is a new transcatheter aortic valve designed for transapical implantation. The six-month results from the completed first-in-man study are reported.METHODS: The Symetis ACURATE TA(™) is composed of a porcine biological tissue valve attached to a self-expandable nitinol stent. It allows for anatomical orientation and facilitates intuitive implantation providing tactile feedback. Since November 2009, a total of 40 high-risk elderly patients have been treated.RESULTS: The mean age of enrolled patients was 83.2 ± 4.0; 60.0% were female, with a mean logistic EuroSCORE of 21.2 ± 10.8% and a mean Society of Thoracic Surgeons (STS) score of 9.0 ± 4.7%. All implants were delivered successfully in the intra-annular and subcoronary position. One patient was converted to conventional surgery due to coronary impingement (after valve-in-valve implantation). One additional patient received valve-in-valve treatment (SAPIEN THV TA(™)). Five patients expired within 30 days and two additional patients expired during the 6-month follow-up due to non-valve-related causes resulting in a mid-term survival rate of 82.5%. Two patients suffered a stroke and another three required new onset pacemaker implantation. The mean aortic gradient significantly improved and remained stable throughout the follow-up (baseline: 51.9 ± 14.3 mmHg, 30 days: 12.3 ± 5.1 mmHg, 6 months: 11.9 ± 5.8 mmHg). At the 6-month follow-up, 96.7% of patients demonstrated either none/trace or mild (1+/4) paravalvular leakage only. According to the Valve Academic Research Council the device's success rate was 92.5%, with a 30-day safety profile of 25%.CONCLUSIONS: At the 6-month follow-up, the ACURATE TA(™) device showed stable valve function with low rates of paravalvular leakages. The cohort of high-risk patients demonstrated good clinical outcomes and 6-month survival.

KW - Aged

KW - Aged, 80 and over

KW - Aortic Valve/surgery

KW - Cause of Death

KW - Female

KW - Heart Valve Diseases/surgery

KW - Heart Valve Prosthesis

KW - Heart Valve Prosthesis Implantation/instrumentation

KW - Humans

KW - Kaplan-Meier Estimate

KW - Male

KW - Minimally Invasive Surgical Procedures/instrumentation

KW - Prospective Studies

KW - Survival Rate

KW - Treatment Outcome

U2 - 10.1093/ejcts/ezs139

DO - 10.1093/ejcts/ezs139

M3 - SCORING: Journal article

C2 - 22491663

VL - 43

SP - 52

EP - 56

JO - EUR J CARDIO-THORAC

JF - EUR J CARDIO-THORAC

SN - 1010-7940

IS - 1

ER -