TY - JOUR
T1 - Lessons learned from the first fully magnetically levitated centrifugal LVAD trial in the United States
T2 - The duraheart trial
AU - Moazami, Nader
AU - Steffen, Robert J.
AU - Naka, Yoshifumi
AU - Jorde, Ulrich
AU - Bailey, Stephen
AU - Murali, Srinivas
AU - Camacho, Margarita T.
AU - Zucker, Mark
AU - Marascalco, Philip J.
AU - Rao, Vivek
AU - Feldman, David
PY - 2014/8
Y1 - 2014/8
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=84905589169&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=84905589169&partnerID=8YFLogxK
U2 - 10.1016/j.athoracsur.2014.04.048
DO - 10.1016/j.athoracsur.2014.04.048
M3 - Article
C2 - 24928670
AN - SCOPUS:84905589169
SN - 0003-4975
VL - 98
SP - 541
EP - 547
JO - Annals of Thoracic Surgery
JF - Annals of Thoracic Surgery
IS - 2
ER -