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

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• 作者：Ivan Netuka ; MD ; PhD^&lowast ; ; ^&dagger ; ; ^{ivan.netuka@ikem.cz" class="auth_mail" title="E-mail the corresponding author} ; Poornima Sood ; MD ; MBA^&Dagger ; ; Yuriy Pya ; MD^§ ; ; Daniel Zimpfer ; MD^‖ ; Thomas Krabatsch ; MD ; PhD^¶ ; ; Jens Garbade ; MD ; PhD^# ; Vivek Rao ; MD ; PhD^&lowast ; &lowast ; ; Michiel Morshuis ; MD^&dagger ; &dagger ; ; Silvana Marasco ; MBBS^&Dagger ; &Dagger ; ; Friedhelm Beyersdorf ; MD^§ ; § ; ; Laura Damme ; RN ; MPH^&Dagger ; ; Jan D. Schmitto ; MD ; PhD^‖‖
• 关键词：HeartMate 3 ; hemolysis ; pump ; quality of life ; thrombosis
• 刊名：Journal of the American College of Cardiology
• 出版年：2015
• 出版时间：15 December 2015
• 年：2015
• 卷：66
• 期：23
• 页码：2579-2589
• 全文大小：2368 K

文摘

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/m² 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. (HeartMate 3™ CE Mark Clinical Investigation Plan [HM3 CE Mark]; NCT02170363)