Journal article
Lessons learned from the first fully magnetically levitated centrifugal LVAD trial in the United States: the DuraHeart trial
The Annals of thoracic surgery, v 98(2), pp 541-547
01 Aug 2014
PMID: 24928670
Featured in Collection : UN Sustainable Development Goals @ Drexel
Abstract
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.
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.
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).
The DuraHeart demonstrated good hemocompatibility; however, the reliability of full magnetic levitation systems should be a high priority in future pump designs.
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Details
- Title
- Lessons learned from the first fully magnetically levitated centrifugal LVAD trial in the United States: the DuraHeart trial
- Creators
- Nader Moazami - Cleveland ClinicRobert J Steffen - Cleveland ClinicYoshifumi Naka - Columbia UniversityUlrich Jorde - Columbia UniversityStephen Bailey - Allegheny General HospitalSrinivas Murali - Allegheny General HospitalMargarita T Camacho - Newark Beth Israel Medical CenterMark Zucker - Newark Beth Israel Medical CenterPhilip J Marascalco - TerumoVivek Rao - Division of Cardiovascular Surgery, Peter Munk Cardiac Centre, Toronto, Ontario, CanadaDavid Feldman - Abbott Northwestern HospitalSUSTAIN Investigators
- Publication Details
- The Annals of thoracic surgery, v 98(2), pp 541-547
- Publisher
- Elsevier
- Resource Type
- Journal article
- Language
- English
- Academic Unit
- Cardiothoracic Surgery; Medicine (Graduate)
- Web of Science ID
- WOS:000341974900031
- Scopus ID
- 2-s2.0-84905589169
- Other Identifier
- 991021960812604721
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- Collaboration types
- Domestic collaboration
- International collaboration
- Web of Science research areas
- Cardiac & Cardiovascular Systems
- Respiratory System
- Surgery