Meeting News

ENDURANCE Supplemental: Centrifugal-flow LVAD with BP management confers benefits

Patients with advanced HF ineligible for a transplant who were implanted with a centrifugal-flow left ventricular assist device and received BP management were more likely to survive and be free of disabling stroke than those implanted with an alternative LVAD, according to the ENDURANCE Supplemental trial results presented at the International Society for Heart and Lung Transplantation Annual Meeting and Scientific Sessions.

The study, conducted by Carmelo Milano, MD, surgical director of cardiac transplantation and left ventricular assist device programs for the division of cardiothoracic surgery at Duke University Medical Center, and colleagues, did not reach its primary endpoint of incidence of neurologic injury, defined as any stroke with modified Rankin scale > 0 at 24 weeks after stroke or transient ischemic attack, at 1 year.

ENDURANCE Supplemental was a prospective, randomized, unblinded trial following the ENDURANCE trial, which showed the centrifugal-flow LVAD was noninferior to an axial-flow LVAD.

Participants were randomly assigned 2:1 to either the centrifugal-flow LVAD (HeartWare VAD System, Medtronic/HeartWare; n = 308) or to a control group of an alternative FDA-approved LVAD (HeartMate II LV Assist System, St. Jude Medical; n = 157).

The primary endpoint for the trial was neurologic injury, and secondary endpoints included BP, survival at 1 year without disabling stroke, death or device malfunction, and functional improvement.

The Supplemental trial did not reach its primary endpoint. In participants receiving the centrifugal-flow LVAD, 14.7% had neurologic injury vs. 12.1% of the control group within 1 year (P = .14).

The BP management protocol in the Supplemental trial resulted in significantly reduced mean arterial BP in participants receiving the centrifugal-flow LVAD vs. the control group and those from the ENDURANCE trial receiving the centrifugal-flow LVAD but not BP management.

Participants receiving the centrifugal-flow LVAD and BP management had higher rates of freedom from death, disabling stroke (modified Rankin scale 4), device exchange and urgent transplant at 1 year (76.4%) vs. the control group (66.9%).

In the ENDURANCE trial, those receiving the centrifugal-flow LVAD but not BP management had slightly lower rates (70.9%) of secondary outcomes vs. the control arm (72.3%; P = .035).

With the BP management protocol, those receiving the centrifugal-flow LVAD had a 24.7% reduction in overall stroke and a 50% reduction in hemorrhagic stokes vs. the study group in the ENDURANCE trial.

“In the ENDURANCE trial, we were concerned about the higher rate of stroke in the [centrifugal-flow LVAD] group compared to the control,” Milano said in a press release. “In the ENDURANCE Supplemental trial, that gap closed and the stroke rates are comparable: There was no statistically significant difference between the [centrifugal-flow LVAD] and [the control group]. We believe the narrowing of those rates was most likely due to [BP] management.” – by Cassie Homer

Reference:

Milano C, et al. Session PL-1. Presented at: International Society for Heart and Lung Transplantation Annual Meeting and Scientific Sessions; April 5-8, 2017; San Diego.

Disclosure : The study was funded by Medtronic/HeartWare. Milano reports consulting for Abbott and Medtronic.

Patients with advanced HF ineligible for a transplant who were implanted with a centrifugal-flow left ventricular assist device and received BP management were more likely to survive and be free of disabling stroke than those implanted with an alternative LVAD, according to the ENDURANCE Supplemental trial results presented at the International Society for Heart and Lung Transplantation Annual Meeting and Scientific Sessions.

The study, conducted by Carmelo Milano, MD, surgical director of cardiac transplantation and left ventricular assist device programs for the division of cardiothoracic surgery at Duke University Medical Center, and colleagues, did not reach its primary endpoint of incidence of neurologic injury, defined as any stroke with modified Rankin scale > 0 at 24 weeks after stroke or transient ischemic attack, at 1 year.

ENDURANCE Supplemental was a prospective, randomized, unblinded trial following the ENDURANCE trial, which showed the centrifugal-flow LVAD was noninferior to an axial-flow LVAD.

Participants were randomly assigned 2:1 to either the centrifugal-flow LVAD (HeartWare VAD System, Medtronic/HeartWare; n = 308) or to a control group of an alternative FDA-approved LVAD (HeartMate II LV Assist System, St. Jude Medical; n = 157).

The primary endpoint for the trial was neurologic injury, and secondary endpoints included BP, survival at 1 year without disabling stroke, death or device malfunction, and functional improvement.

The Supplemental trial did not reach its primary endpoint. In participants receiving the centrifugal-flow LVAD, 14.7% had neurologic injury vs. 12.1% of the control group within 1 year (P = .14).

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The BP management protocol in the Supplemental trial resulted in significantly reduced mean arterial BP in participants receiving the centrifugal-flow LVAD vs. the control group and those from the ENDURANCE trial receiving the centrifugal-flow LVAD but not BP management.

Participants receiving the centrifugal-flow LVAD and BP management had higher rates of freedom from death, disabling stroke (modified Rankin scale 4), device exchange and urgent transplant at 1 year (76.4%) vs. the control group (66.9%).

In the ENDURANCE trial, those receiving the centrifugal-flow LVAD but not BP management had slightly lower rates (70.9%) of secondary outcomes vs. the control arm (72.3%; P = .035).

With the BP management protocol, those receiving the centrifugal-flow LVAD had a 24.7% reduction in overall stroke and a 50% reduction in hemorrhagic stokes vs. the study group in the ENDURANCE trial.

“In the ENDURANCE trial, we were concerned about the higher rate of stroke in the [centrifugal-flow LVAD] group compared to the control,” Milano said in a press release. “In the ENDURANCE Supplemental trial, that gap closed and the stroke rates are comparable: There was no statistically significant difference between the [centrifugal-flow LVAD] and [the control group]. We believe the narrowing of those rates was most likely due to [BP] management.” – by Cassie Homer

Reference:

Milano C, et al. Session PL-1. Presented at: International Society for Heart and Lung Transplantation Annual Meeting and Scientific Sessions; April 5-8, 2017; San Diego.

Disclosure : The study was funded by Medtronic/HeartWare. Milano reports consulting for Abbott and Medtronic.