Edwards Lifesciences
(NYSE: EW)
today announced results from a registry demonstrating the effect of software on reducing hypotension.
The EU-HYPROTECT registry evaluated patients having non-cardiac surgery. Results indicated that the Edwards Acumen HPI software may help reduce the duration and severity of intraoperative hypotension.
Edwards said the European multicenter prospective observational registry included, in its final analysis, 702 patients. These patients, scheduled for elective major non-cardiac surgery, spanned 12 medical centers in France, Germany, Italy, Spain and the UK. The company said it marks the first multicenter registry involving a predictive monitoring technology. It establishes a large, prospectively college database on hypotension management in patients undergoing non-cardiac surgery. All patients had intraarterial blood pressure monitoring with an arterial catheter and intraoperative Acumen HPI software.
Edwards developed its Acumen HPI software 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.
About the Edwards software analysis
According to Edwards, both the duration and severity of intraoperative hypotension are associated with postoperative complications. The investigators set the primary endpoint for the registry as intraoperative hypotension quantified using the time-weighted average mean arterial pressure (MAP) <65 mmHg. The study defined secondary endpoints as the proportion of patients with at least one ≥1-min-episode of a MAP <65 mmHg, and the number of ≥1-min-episodes of a MAP <65 mmHg.
Between September 2021 and May 2022, the registry enrolled 749 patients. In total, the final analysis included 702 patients. Edwards reports the median time-weighted average MAP <65 mmHg as 0.03 (0.00, 0.20) mmHg. The study saw 285 patients (41%) with no ≥1-minute episode of a MAP <65 mmHg. Meanwhile, 417 patients (59%) registered at least one. The median number of ≥1-minute episodes of a MAP <65 mmHg totaled one (0, 3).
The study also saw the incidence of acute kidney injury fall at the lower end of what is reported in 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.”
