Acumen IQ cuff and Acumen HPI software

About the Trial

The HPI Care Trial is designed to determine whether the use of the Acumen Hypotension Prediction Index (HPI) software to guide hemodynamic management in patients undergoing cardiac surgery requiring cardiopulmonary bypass reduces the mean duration of hypotension (defined as mean arterial pressure (MAP) < 65 mmHg for at least one minute) from the post bypass period in the cardiac operating room (OR) and the cardiovascular intensive care unit (CVICU).

Intraoperative Hypotension

Though many studies have been conducted on the risks of intraoperative hypotension during noncardiac surgery, intraoperative hypotension during cardiac surgery and post-cardiac surgery is relatively unexplored. There is an unmet need in cardiac surgery and the cardiovascular intensive care unit (CVICU), as there is a lack of research into the impact that reduced hypotension may have on this patient population, and studies have not yet been conducted to determine whether hemodynamic goal-directed therapies could improve the burden of intraoperative hypotension in these patients.

Acumen IQ cuff and Acumen HPI software
Acumen IQ cuff and Acumen HPI software

The Technology

  • Acumen Hypotension Prediction Index software, predicts the likelihood of a patient trending towards a hypotensive event,* is unlocked by minimally-invasive Acumen IQ sensor.
  • ForeSight sensor continuously monitors cerebral oxygen saturation noninvasively
*A hypotensive event is defined as MAP <65 mmHg for a duration of at least one minute.

Patient eligibility

Inclusion criteria:

  1. At least 18 years of age
  2. Has signed the informed consent form
  3. Has planned pressure monitoring with an arterial line
  4. Has planned sternotomy
  5. Has planned general anesthesia
  6. Has ASA Physical Status ≤ 4
  7. Has planned cerebral oximetry monitoring
  8. Has a planned overnight hospitalization
  9. Has a planned cardiopulmonary bypass (CPB) “on-pump” surgery

Exclusion criteria:

  1. Has a physical site area too limited for proper sensor placement
  2. Has contraindications for arterial line placement
  3. Is participating in another (interventional) study
  4. An intraoperative MAP target will be <65 mmHg
  5. Pre-op or pre-pump or post-pump LVEF ≤ 15%
  6. Requiring heart transplant
  7. Pre-existing circulatory support devices or planned circulatory support devices post-bypass
  8. Requiring emergency surgery
  9. Known or identified severe PAH as determined by a preoperative echocardiogram or intraoperative Swan-Ganz catheter
  10. Cardiovascular instability in the operating room necessitating the need to go back on bypass for a subsequent run
Acumen IQ cuff and Acumen HPI software

Cohort design

This is currently planned to be a single-site trial and will be taking place at Wake Forest Baptist Medical Center.

Someone in this trial can expect to be randomized to either the HPI software group (use of Acumen HPI software) or the control group (standard of care). If the patient is randomized into the HPI software group, the clinician will use the Acumen HPI software to guide hemodynamic management in the patient post bypass in the OR and for up to 8 hours in the CVICU. The patient will then be expected to complete follow-up surveys led by site staff until discharge. At 30 days post-surgery, the patient will complete another follow-up.

Support Agent

We’re here for you

We are committed to providing the highest levels of customer service to help our patients improve their quality of life. For any questions, or if you are interested in being part of this study, contact Edwards Patient Support Center. For details about the trial, visit
NCT05083403 at Clinical Trials.gov.

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Give us a call
(888) 713-1564

Important safety information

CAUTION: Federal (United States) law restricts this device to sale by or on the order of a physician.
See Instructions For Use (IFU) / Directions For Use (DFU) for full prescribing information, including indications, contraindications, warnings, precautions and adverse events.

Important safety information

CAUTION: Federal (United States) law restricts this device to sale by or on the order of a physician.
See Instructions For Use (IFU) / Directions For Use (DFU) for full prescribing information, including indications, contraindications, warnings, precautions and adverse events.

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