Ivan Netuka1, Poornima Sood2, Yuriy Pya3, Daniel Zimpfer4, Thomas Krabatsch5, Jens Garbade6, Vivek Rao7, Michiel Morshuis8, Silvana Marasco9, Friedhelm Beyersdorf10, Laura Damme2, Jan D Schmitto11. 1. 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. 2. Clinical Affairs, St. Jude Medical, Burlington, Massachusetts. 3. National Research Cardiac Surgery Center, Astana, Kazakhstan. 4. Department of Surgery, Division of Cardiac Surgery, Medical University of Vienna, Vienna, Austria. 5. Department of Cardiothoracic and Vascular Surgery, German Heart Center, Berlin, Germany. 6. Heart Center Leipzig, Department of Cardiac Surgery, University of Leipzig, Leipzig, Germany. 7. Toronto General Hospital, Toronto, Canada. 8. Thoracic and Cardiovascular Surgery Clinic, Bad Oeynhausen, Germany. 9. Cardiothoracic Surgical Unit, The Alfred Hospital, Melbourne, Australia. 10. Department of Cardiovascular Surgery Freiburg, University Heart Center Freiburg-Bad Krozingen, Freiburg, Germany. 11. Department of Cardiac, Thoracic, Transplantation and Vascular Surgery, Hannover Medical School, Hannover, Germany.
Abstract
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).
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).
Authors: Jonathan S Gordon; Elizabeth J Maynes; Thomas J O'Malley; Behzad B Pavri; Vakhtang Tchantchaleishvili Journal: J Interv Card Electrophysiol Date: 2021-01-12 Impact factor: 1.900
Authors: Christina Feldmann; Anamika Chatterjee; Jasmin S Hanke; Guenes Dogan; Axel Haverich; Jan D Schmitto Journal: J Thorac Dis Date: 2017-06 Impact factor: 2.895
Authors: Marcel Ricklefs; Jasmin S Hanke; Guenes Dogan; Anamika Chatterjee; Christina Feldmann; Ezin Deniz; Wilhelm Korte; Felix Kirchhoff; Axel Haverich; Jan D Schmitto Journal: J Thorac Dis Date: 2018-06 Impact factor: 2.895