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Edwards Lifesciences announces study findings that support the use of its Acumen HPI software

Edwards Lifesciences, has recently unveiled study findings endorsing the effectiveness of its Acumen HPI software.

Data from the EU-HYPROTECT registry indicates that the implementation of Acumen HPI could potentially lead to a reduction in the severity and duration of intraoperative hypotension in non-cardiac surgery patients. In June, Edwards had previously presented registry results showcasing the software’s achievements.

The company developed Acumen HPI with the intention of providing medical professionals with insights into the likelihood of hypotension occurrence in patients. The software employs an algorithm that processes data from hemodynamic monitoring during perioperative management. Through predictive analytics, it alerts clinicians about potential drops in blood pressure before they happen.

Acumen HPI received FDA 510(k) clearance in June 2022.

This European multicenter prospective observational registry involved 702 patients in its final assessment. These patients, who were scheduled for elective major non-cardiac surgery, were sourced from 12 medical centers spanning five countries. Edwards highlights that this marks the first multicenter registry to incorporate predictive monitoring technology, creating a substantial, prospectively gathered hypertension management database. All patients underwent intraarterial blood pressure monitoring via an arterial catheter, coupled with intraoperative utilization of the Acumen HPI software.

The primary focus of Edwards was intraoperative hypotension, assessed using the time-weighted average mean arterial pressure (MAP) of less than 65 mmHg. Secondary objectives comprised the proportion of patients with at least one episode of MAP dropping below 65 mmHg for a duration of one minute or longer. It also encompassed the count of episodes of MAP below 65 mmHg lasting at least one minute.

The registry enrolled 749 patients from September 2021 to May 2022, with 702 subjects included in the final analysis. The median time-weighted average MAP below 65 mmHg was recorded at 0.03. Edwards reported that 285 patients (41%) had no MAP episodes exceeding one minute, with a median count of one such episode.

Additionally, Edwards noted that although the study was not specifically powered for this aspect, instances of acute kidney injury were observed at the lower end of the typical range for patients undergoing major non-cardiac surgery.

“The consequences of the COVID-19 pandemic have drastically accelerated the need for solutions that improve patient safety and outcomes, reduce hospital length of stay and increase hospital efficiencies,” said Edwards senior director of medical affairs, Thomas Scheeren. “The results of the EU-HYPROTECT registry are promising and demonstrate the need to better monitor hypotension in the perioperative pathway. Improving patient safety and outcomes is our ultimate goal and we believe the use of predictive monitoring can help achieve this.”

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