Blood Pressure and Outcomes in Contemporary Left Ventricular Assist Device Recipients

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Blood Pressure and Outcomes in Contemporary Left Ventricular Assist Device Recipients PI: Himabindu Vidula, MD, MS University of Rochester Medical Center, Rochester, NY A growing number of advanced heart failure patients are supported by a continuous-flow (CF) left ventricular assist device (LVAD) around the world, but the optimal blood pressure (BP) range for patients on CF-LVAD support has yet to be fully characterized. Previous studies of patients with older LVAD technology have suggested that elevated BP is associated with adverse outcomes, including stroke and mortality. However, the thresholds for maximal and minimal BP for patients supported by contemporary centrifugal flow pumps, such as the HeartMate 3 (HM3) LVAD, are largely based on expert consensus. In addition, limited data exist regarding the lower limit for BP control and BP goals for women, Blacks, and patients with right heart failure (RHF). Finally, the optimal anti-hypertensive medication regimen for LVAD patients is not well defined. A recent study from the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) suggested that both low and very high BP are associated with increased mortality in CF-LVAD patients, but these retrospective analyses were limited by the availability of BP measurements only at fixed timepoints unrelated to the time of the adverse event. Our preliminary data from the University of Rochester Database, employing time-dependent analysis of 66,618 non-invasive BP measurements in 310 CF-LVAD patients, demonstrate that maintaining mean arterial pressure (MAP) less than 80 mmHg is associated with increased risk of stroke or death during the first year after LVAD implantation. Furthermore, our findings suggest a sex and racial difference in optimal BP thresholds. The association of BP and stroke or death has not been previously studied in a prospective study of HM3 LVAD patients and accordingly BP guidelines in this population are not well defined. We propose a prospective study of 200 newly implanted HM3 LVAD outpatients at 4 different LVAD implantation centers. Following index discharge, patients will measure their BP at home 3 days a week for a 6-month period with a Doppler ultrasound in addition to a standardized protocol of weekly home BP measurements and in-clinic BP assessment every 3 months throughout follow-up. BP will be assessed as a time-dependent covariate for the endpoint of stroke or death. We will evaluate the following specific aims: Specific aim #1 is to validate our findings regarding the association of low BP and the risk of stroke or death and to identify appropriate BP thresholds in HM3 LVAD patients. Specific aim #2 is to determine the optimal BP range in the following subgroups: 1) women as compared to men; 2) Black vs. White; and 3) patients with RHF as compared to patients without RHF. Specific aim #3 is to evaluate the interaction of anti-hypertensive medication use with BP to identify the optimal medical regimen for LVAD patients. Findings from this study, using novel modalities of home BP monitoring with a prespecified follow-up protocol, have important implications for the prevention of death and stroke in LVAD patients and will be used to guide management in this growing population.