Fully Magnetically Levitated Left Ventricular Assist System for Treating Advanced HF A Multicenter Study

JOURNAL OF THE AMERICAN COLLEGE OF CARDIOLOGY

卷:66

Article

Netuka, Ivan^1,2  Sood, Poornima³  Pya, Yuriy⁴  Zimpfer, Daniel⁵  Krabatsch, Thomas⁶  Garbade, Jens⁷  Rao, Vivek⁸  Morshuis, Michiel⁹  Marasco, Silvana¹⁰  Beyersdorf, Friedhelm¹¹  Damme, Laura³  Schmitto, Jan D.¹² 

[1] Inst Clin & Expt Med, Dept Cardiac Surg, Prague 14021 4, Czech Republic

[2] Charles Univ Prague, Fac Med 1, Dept Cardiovasc Surg, Dept Surg 2, Prague, Czech Republic

[3] St Jude Med, Clin Affairs, Burlington, MA USA

[4] Natl Res Cardiac Surg Ctr, Astana, Kazakhstan

[5] Med Univ Vienna, Div Cardiac Surg, Dept Surg, Vienna, Austria

[6] German Heart Ctr, Dept Cardiothorac & Vasc Surg, Berlin, Germany

[7] Univ Leipzig, Heart Ctr Leipzig, Dept Cardiac Surg, D-04109 Leipzig, Germany

[8] Toronto Gen Hosp, Toronto, ON, Canada

[9] Thorac & Cardiovasc Surg Clin, Bad Oeynhausen, Germany

[10] Alfred Hosp, Cardiothorac Surg Unit, Melbourne, Vic, Australia

[11] Univ Heart Ctr Freiburg Bad Krozingen, Dept Cardiovasc Surg Freiburg, Freiburg, Germany

[12] Hannover Med Sch, Dept Cardiac Thorac Transplantat & Vasc Surg, Hannover, Germany

关键词: HeartMate 3;    hemolysis;    pump;    quality of life;    thrombosis;   

DOI  :  10.1016/j.jacc.2015.09.083

来源: Elsevier

【 摘 要 】

BACKGROUND The HeartMate 3 left ventricular assist system (LVAS) is intended to provide long-term support to patients with advanced heart failure. The centrifugal flow pump is designed for enhanced hemocompatibility by incorporating a magnetically levitated rotor with wide blood-flow paths and an artificial pulse. OBJECTIVES The aim of this single-arm, prospective, multicenter study was to evaluate the performance and safety of this LVAS. METHODS The primary endpoint was 6-month survival compared with INTERMACS (Interagency Registry for Mechanically Assisted Circulatory Support)-derived performance goal. Patients were adults with ejection fraction <= 25%, cardiac index <= 2.2 l/min/m(2) without inotropes or were inotrope-dependent on optimal medical management, or listed for transplant. RESULTS Fifty patients were enrolled at 10 centers. The indications for LVAS support were bridge to transplantation (54%) or destination therapy (46%). At 6 months, 88% of patients continued on support, 4% received transplants, and 8% died. Thirty-day mortality was 2% and 6-month survival 92%, which exceeded the 88% performance goal. Support with the fully magnetically levitated LVAS significantly reduced mortality risk by 66% compared with the Seattle Heart Failure Model-predicted survival of 78% (p = 0.0093). Key adverse events included reoperation for bleeding (14%), driveline infection (10%), gastrointestinal bleeding (8%), and debilitating stroke (modified Rankin Score >3) (8%). There were no pump exchanges, pump malfunctions, pump thrombosis, or hemolysis events. New York Heart Association classification, 6-min walk test, and quality-of-life scores showed progressive and sustained improvement. CONCLUSIONS The results show that the fully magnetically levitated centrifugal-flow chronic LVAS is safe, with high 30-day and 6-month survival rates, a favorable adverse event profile, and improved quality of life and functional status. (C) 2015 by the American College of Cardiology Foundation.

【 授权许可】

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