Nader Moazami1, Robert J Steffen2, Yoshifumi Naka3, Ulrich Jorde4, Stephen Bailey5, Srinivas Murali6, Margarita T Camacho7, Mark Zucker8, Philip J Marascalco9, Vivek Rao10, David Feldman11. 1. Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio. Electronic address: moazamn@ccf.org. 2. Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio. 3. Division of Cardiothoracic Surgery, Columbia University, New York, New York. 4. Division of Cardiology, Columbia University, New York, New York. 5. Division of Cardiothoracic Surgery, Allegheny General Hospital, Pittsburgh, Pennsylvania. 6. Division of Cardiology, Allegheny General Hospital, Pittsburgh, Pennsylvania. 7. Division of Cardiac Surgery, Newark Beth Israel Medical Center, Newark, New Jersey. 8. Division of Cardiology, Newark Beth Israel Medical Center, Newark, New Jersey. 9. Terumo Heart, Inc, Ann Arbor, Michigan. 10. Division of Cardiovascular Surgery, Peter Munk Cardiac Centre, Toronto, Ontario, Canada. 11. Department of Cardiology, Minneapolis Heart Institute at Abbott Northwestern Hospital, Minneapolis, Minnesota.
Abstract
BACKGROUND: The DuraHeart is a continuous centrifugal-flow left ventricular assist device that uses active magnetic levitation for impeller positioning designed for improved hemocompatibility and durability. This study reviews the results of the US trial with specific attention to hemolysis, thrombotic complications, and pump failure. METHODS: The US SUSTAIN trial was a multicenter, prospective, single-arm observational study in advanced heart failure patients listed for transplantation. Follow-up was complete in 100% of the patients at 6 months. RESULTS: Sixty-three patients were enrolled at 23 centers. Forty-six patients (73%) reached the primary end points of survival to transplantation, alive on the original device at 180 days and listed for transplantation, or explant for recovery. Median duration of support was 267 days (range, 10 to 952 days) with a total support time of 46 patient-years. There was no clinical hemolysis reported during the study. Mean lactate dehydrogenase values peaked at day 4 and significantly decreased during support (435±236 U/L and 297±142 U/L on day 3 and day 180, respectively). There were no cases of pump thrombosis reported, and 3 cases of pump thrombus "in transit" (0.06 events/patient-year) were observed. There were 6 (10%) cases of magnetic levitation system failure, all secondary to cable wire fractures (0.12 events/patient-year). All patients were hemodynamically stable with the backup hydrodynamic mode. Major adverse events included gastrointestinal bleeding (0.52 events/patient-year), ischemic and hemorrhagic strokes (0.17 events/patient-year and 0.09 events/patient-year, respectively), and driveline infections (0.67 events/patient-year). CONCLUSIONS: The DuraHeart demonstrated good hemocompatibility; however, the reliability of full magnetic levitation systems should be a high priority in future pump designs.
BACKGROUND: The DuraHeart is a continuous centrifugal-flow left ventricular assist device that uses active magnetic levitation for impeller positioning designed for improved hemocompatibility and durability. This study reviews the results of the US trial with specific attention to hemolysis, thrombotic complications, and pump failure. METHODS: The US SUSTAIN trial was a multicenter, prospective, single-arm observational study in advanced heart failurepatients listed for transplantation. Follow-up was complete in 100% of the patients at 6 months. RESULTS: Sixty-three patients were enrolled at 23 centers. Forty-six patients (73%) reached the primary end points of survival to transplantation, alive on the original device at 180 days and listed for transplantation, or explant for recovery. Median duration of support was 267 days (range, 10 to 952 days) with a total support time of 46 patient-years. There was no clinical hemolysis reported during the study. Mean lactate dehydrogenase values peaked at day 4 and significantly decreased during support (435±236 U/L and 297±142 U/L on day 3 and day 180, respectively). There were no cases of pump thrombosis reported, and 3 cases of pump thrombus "in transit" (0.06 events/patient-year) were observed. There were 6 (10%) cases of magnetic levitation system failure, all secondary to cable wire fractures (0.12 events/patient-year). All patients were hemodynamically stable with the backup hydrodynamic mode. Major adverse events included gastrointestinal bleeding (0.52 events/patient-year), ischemic and hemorrhagic strokes (0.17 events/patient-year and 0.09 events/patient-year, respectively), and driveline infections (0.67 events/patient-year). CONCLUSIONS: The DuraHeart demonstrated good hemocompatibility; however, the reliability of full magnetic levitation systems should be a high priority in future pump designs.
Authors: Marykay A Pavol; Joshua Z Willey; Ying Wei; Melana Yuzefpolskaya; Randolph S Marshall; Philip J Marascalco; Jason Harwood; Ronald M Lazar Journal: Gen Thorac Cardiovasc Surg Date: 2018-05-23
Authors: John C O'Horo; Omar M Abu Saleh; John M Stulak; Mark P Wilhelm; Larry M Baddour; M Rizwan Sohail Journal: ASAIO J Date: 2018 May/Jun Impact factor: 2.872