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In LVAD cohort, stroke severity greatly affects mortality
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In a new analysis of the ENDURANCE and ENDURANCE Supplemental trials of patients with advanced HF requiring a left ventricular assist device as destination therapy, stroke severity significantly affected mortality and BP control reduced stroke and stroke mortality risk.
The researchers retrospectively analyzed 205 patients from ENDURANCE and ENDURANCE Supplemental who had a stroke within 2 years of implantation of either a centrifugal-flow LVAD (HeartWare VAD system, Medtronic) or an axial-flow LVAD (HeartMate II, Abbott). They presented their findings at the Annual Meeting and Scientific Sessions of the International Society for Heart and Lung Transplantation.
“We saw a lower incidence of stroke associated with more tight blood pressure management” in the ENDURANCE trial, Jeffrey Teuteberg, MD, associate professor of medicine at Stanford University Medical Center and section chief of heart failure, transplant and mechanical circulatory support at Stanford Health Care, told Cardiology Today. “That led to the ENDURANCE Supplemental trial, where we saw that if we managed blood pressure in a prospective study, it led to lower rates of stroke. This study followed up on that to gauge the impact of stroke severity on survival after stroke.”
The ENDURANCE trial compared the two devices, whereas ENDURANCE Supplemental evaluated a BP management system employed to reduce stroke risk in the cohort.
Severely disabling stroke was defined as modified Rankin Scale score of 4 to 6.
At 1 year, among those assigned the centrifugal-flow LVAD, 76% of patients with nondisabling stroke survived compared with 29% of patients with disabling stroke (P < .0001), whereas among those assigned the axial-flow LVAD, 71% of patients with nondisabling stroke survived compared with 17% of patients with disabling stroke (P < .0001), Palak Shah, MD, MS, assistant clinical professor of medicine at George Washington University School of Medicine and Health Sciences and director of the Inova Cardiovascular Genomics Center at Inova Heart and Vascular Institute, said during a presentation.
At 1 year, among those assigned the centrifugal-flow LVAD, the survival rates were 69% for nondisabling stroke and 26% for severely disabling stroke in the ENDURANCE study (P < .0001) and 84% for nondisabling stroke and 33% for severely disabling stroke in the ENDURANCE Supplemental study (P = .0002).
Among patients assigned the centrifugal-flow LVAD, freedom from severely disabling stroke at 2 years was 85% in the ENDURANCE study and 91% in the ENDURANCE Supplemental study (P = .06), Shah said during the presentation.
“The findings re-emphasize the importance of blood pressure control that we saw in the original trial, and we also saw a reduction in the incidence of severely disabling stroke and in the mortality of people who had stroke,” Teuteberg said in an interview. “Managing the simple things can make huge impacts on major adverse events.” – by Erik Swain
Reference:
Shah P, et al. Abstract 145. Presented at: Annual Meeting and Scientific Sessions of the International Society for Heart and Lung Transplantation; April 3-6, 2019; Orlando.
Disclosures: The study was funded by Medtronic. Shah reports he receives research grants from Abbott and Medtronic. Teuteberg reports he serves on scientific advisory boards for Abiomed, CareDx and Medtronic and on the clinical events committee of a trial sponsored by Abbott and has served as a speaker for Medtronic.