Hypotension prediction index smart alerts and trends to improve compliance with goal-directed hemodynamic therapy: a feasibility study.

BACKGROUND: Goal-directed hemodynamic therapy (GDHT) and Hypotension Prediction Index (HPI, Edwards Lifesciences, Irvine, CA) technology are used to improve post-operative patient outcomes. Trials evaluating GDHT are frequently limited by poor algorithm compliance. The Acumen HPI Software incorporates smart trends and alerts that highlight the probable mechanism(s) of hypotension and facilitate compliance with the GDHT algorithm. We hypothesized that prompts from the Acumen HPI Smart Alerts would improve compliance to a GDHT algorithm during moderate-to-high-risk elective noncardiac surgery. METHODS: This IRB-approved, multicenter, mixed-methods, single-arm feasibility trial included adults undergoing elective, moderate-to-high-risk noncardiac surgery requiring intra-arterial blood pressure monitoring. The HPI-guided GDHT algorithm included actionable trends at HPI > 50 and automated HPI Smart Alert notifications at HPI ≥ 85, displaying the most likely hypotension mechanism(s). The primary outcome was the proportion of HPI notifications resulting in timely algorithm-concordant interventions. The sample size was estimated to achieve a true compliance rate of at least 75% with a 95% confidence level above 60%. RESULTS: A total of 122 subjects were included. The enrollment among centers was balanced. The overall compliance rate was 77.1% (95% CI: 74.5-79.6%). The median area under the curve, time-weighted average, and minutes of hypotension below 65 mmHg were 8.8 (0.3, 33.7) mmHg*min, 0.0 (0.0, 0.1) mmHg, and 2.9 (0.4, 8.7) minutes, respectively. CONCLUSIONS: This study demonstrated the potential for HPI Smart Alerts to improve compliance with an intraoperative GDHT algorithm in adults undergoing moderate to high-risk non-cardiac surgery. A low burden of intra-operative hypotension was observed, suggesting potential decreases in other associated adverse outcomes. Larger-scale randomized studies are warranted. TRIAL REGISTRATION: This trial was retrospectively registered at ClinicalTrials.gov on 14 July 2023 (NCT05957406).