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, Jahrgang 43, Nr. 1, 01.2013, S. 52-56.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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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 -