Edwards Lifesciences
(NYSE: EW)
today announced study results that support the use of its Acumen HPI software.
Results from the EU-HYPROTECT registry indicate that using Acumen HPI may help reduce the duration and severity of intraoperative hypotension in patients having non-cardiac surgery. In June, Edwards shared results from the registry that also demonstrated the software’s success.
The company developed Acumen HPI to provide clinicians with information regarding the likelihood of a patient developing hypotension. The software uses an algorithm that calculates data from hemodynamic monitoring in perioperative management. It then leverages predictive analytics to alert clinicians of potential blood pressure drops before they occur.
Acumen HPI received FDA 510(k) clearance in June 2022.
The European, multicenter, prospective, observational registry included 702 patients in its final analysis. These patients, scheduled for elective major non-cardiac surgery, spanned 12 medical centers in five countries. Edwards says it marked he first multicenter registry to involve a predictive monitoring technology. It established a large, prospectively collected database on hypertension management. All patients had intraarterial blood pressure monitoring with an arterial catheter and intraoperative Acumen HPI software.
Edwards set its primary endpoint as intraoperative hypotension quantified using the time-weighted average mean arterial pressure (MAP) less than 65 mmHg. Secondary endpoints included the proportion of patients with at least one episode of a MAP less than 65 mmHg for at least one minute or longer. They also included the number of at least one minute episodes of MAP at less than 65 mmHg.
The registry enrolled 749 patients between September 2021 and May 2022, with 702 included in the final analysis. Median time-weighted average MAP less than 65 mmHG came in at 0.03. Edwards reported that 285 patients (41%) had no MAP episode greater than one minute. The median number of those episodes was reported as one.
Edwards also said that — while not powering the study for this outcome — it saw acute kidney injury incidences at the lower end of usual reports for patients having 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 Thomas Scheeren, senior director of medical affairs EMEACLA at Edwards. “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.”
