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

I. Netuka, P. Sood, Y. Pya, D. Zimpfer, T. Krabatsch, J. Garbade, V. Rao, M. Morshuis, S. Marasco, F. Beyersdorf, L. Damme, JD. Schmitto,

. 2015 ; 66 (23) : 2579-89.

Language English Country United States

Document type Clinical Trial, Journal Article, Multicenter Study, Research Support, Non-U.S. Gov't

Persistent link   https://www.medvik.cz/link/bmc16020089

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

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$a Netuka, Ivan $u Department of Cardiac Surgery, Institute for Clinical and Experimental Medicine, Prague, Czech Republic; Second Department of Surgery, Department of Cardiovascular Surgery, First Faculty of Medicine, Charles University in Prague, Prague, Czech Republic. Electronic address: ivan.netuka@ikem.cz.
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$a 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. (HeartMate 3™ CE Mark Clinical Investigation Plan [HM3 CE Mark]; NCT02170363).
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$a Sood, Poornima $u Clinical Affairs, St. Jude Medical, Burlington, Massachusetts.
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$a Pya, Yuriy $u National Research Cardiac Surgery Center, Astana, Kazakhstan.
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$a Zimpfer, Daniel $u Department of Surgery, Division of Cardiac Surgery, Medical University of Vienna, Vienna, Austria.
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$a Morshuis, Michiel $u Thoracic and Cardiovascular Surgery Clinic, Bad Oeynhausen, Germany.
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$a Marasco, Silvana $u Cardiothoracic Surgical Unit, The Alfred Hospital, Melbourne, Australia.
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$a Beyersdorf, Friedhelm $u Department of Cardiovascular Surgery Freiburg, University Heart Center Freiburg-Bad Krozingen, Freiburg, Germany.
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$a Damme, Laura $u Clinical Affairs, St. Jude Medical, Burlington, Massachusetts.
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