# Blood Pressure and Outcomes in Contemporary Left Ventricular Assist Device Recipients

> **NIH NIH R01** · UNIVERSITY OF ROCHESTER · 2022 · $576,509

## Abstract

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 re...

## Key facts

- **NIH application ID:** 10428457
- **Project number:** 5R01HL155201-02
- **Recipient organization:** UNIVERSITY OF ROCHESTER
- **Principal Investigator:** Himabindu Vidula
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $576,509
- **Award type:** 5
- **Project period:** 2021-06-15 → 2023-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10428457

## Citation

> US National Institutes of Health, RePORTER application 10428457, Blood Pressure and Outcomes in Contemporary Left Ventricular Assist Device Recipients (5R01HL155201-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10428457. Licensed CC0.

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