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

被引：55

作者：

Kempfert, Joerg ^{[1
]}

Treede, Hendrik ^{[2
]}

Rastan, Ardawan J. ^{[3
]}

Schoenburg, Markus ^{[1
]}

Thielmann, Matthias ^{[4
]}

Sorg, Stefan ^{[5
]}

Mohr, Friedrich-W. ^{[3
]}

Walther, Thomas ^{[1
]}

机构：

[1] Kerckhoff Clin Bad Nauheim, Dept Cardiac Surg, D-61231 Bad Nauheim, Germany

[2] Univ Hamburg, Dept Cardiac Surg, Heartctr, Hamburg, Germany

[3] Univ Leipzig, Dept Cardiac Surg, Heartctr, Leipzig, Germany

[4] Univ Duisburg Essen, West German Heart Ctr Essen, Dept Cardiac Surg, Essen, Germany

[5] Univ Freiburg, Dept Cardiac Surg, Clin Cardiac Surg, D-79106 Freiburg, Germany

来源：

EUROPEAN JOURNAL OF CARDIO-THORACIC SURGERY | 2013年 / 43卷 / 01期

关键词：

Aortic valve implantation; Minimally invasive; Transapical; HIGH-RISK PATIENTS; OUTCOME SOURCE REGISTRY; EDWARDS SAPIEN VALVE; EUROPEAN REGISTRY; TRANSCATHETER; REPLACEMENT; EXPERIENCE; STENOSIS; PROSTHESIS; PREDICTORS;

D O I：

10.1093/ejcts/ezs139

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

The ACURATE TA((TM)) 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. The Symetis ACURATE TA((TM)) 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. 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((TM))). 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%. At the 6-month follow-up, the ACURATE TA((TM)) 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.

引用

页码：52 / 57

页数：6

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