NCT06347211

"Hypotension Probability Indicator" in TAVI/MitraClip for Hypotension Management

Is the Hypotension Probability Indicator with Goal Directed Haemodynamic Treatment Useful in Predicting and Treating Hypotension in Patients Undergoing Transcatheter Aortic Valve Implantation(TAVI) or MitraClip

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Attikon Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study will investigate whether the use of Goal Directed Hemodynamic Therapy implemented with the HPI algorithm using a treatment algorithm will reduce the incidence of hypotension and improve treatment of hypotension.

Detailed description

The perioperative period is characterized by hemodynamic instability. Intraoperative hypotension (IOH) can be caused by anesthesia drugs, surgical manipulations, hypovolemia or inhibition of the sympathetic nervous system and impairment of baroreflex regulatory mechanisms. In a retrospective analysis performed at the Cleveland Clinic, the risk for acute kidney injury(AKI) and myocardial injury (MI) increased when mean arterial pressure (MAP) was less than 55 mmHg. Further, even short durations of intraoperative hypotension were associated with AKI and MI. Salmasi and coll analyzed whether associations based on relative thresholds were stronger than those based on absolute thresholds regarding blood pressure. They found that there were no clinically important interactions between preoperative blood pressures and the relationship between hypotension and MI or AKI at intraoperative mean arterial blood pressures less than 65 mmHg. Absolute and relative thresholds had comparable ability to discriminate patients with MI or AKI from those without it. The authors concluded that anesthetic management can thus be based on intraoperative pressures without regard to preoperative pressure. In a retrospective cohort study Sun and coll conclude that an increased risk of postoperative stage I AKI occurs when intraoperative MAP was less than 60 mmHg for more than 20 min and less than 55 mmHg for more than 10 min. Hence it is fundamental for the management of any hemodynamically unstable patient the rapid assessment of the factors that determine the cardiovascular collapse, followed by prompt treatment and, ultimately, reversal of the responsible process. Recently a Hypotension Probability Indicator (HPI) algorithm has been developed from Edwards Lifesciences using continuous invasively-measured arterial waveforms to predict hypotension with high accuracy minutes before blood pressure actually decreases. The HPI algorithm can be integrated with a goal-directed hemodynamic treatment (GDHT) to achieve hemodynamic optimization by increasing global blood flow and prevent organ failure. The HPI index, combined with a hypotension management protocol, has shown efficacy in reducing hypotension during surgical procedures. Its effectiveness has been demonstrated in ICU patients with Covid-19. Studies in cardiac surgery cases have been conducted, with ongoing research in cardiac surgery patients (HYPE2 and HPI Care Trial). Maintaining stable arterial pressure and avoiding intraoperative hypotension are crucial during TAVI or MitraClip procedures, achieved through monitored anesthesia care (MAC) or general anesthesia. Based on recent publications and Pinsky's work, a hypotension management protocol integrating GDHT with the HPI algorithm has been developed for TAVI or MitraClip patients.

Conditions

• Hypotension During Surgery
• Prevention of Hypotension

Interventions

Type	Name	Description
DEVICE	Acumen IQ sensor with Hemosphere monitor incorporating the HPI algorithm	Hemosphere monitoring and requires the use of a AcumenIQ sensor connected to an arterial line (Edwards Lifesciences Corp., Irvine, CA, USA). The sensor has a splitter which enables the splitting of the arterial blood pressure signal to facilitate a blood pressure signal on both the anesthesia machine monitor (standard care) and the HemoSphere monitor (study). In the intervention arm we asked the anesthesiologist and anesthesia nurse to use the study treatment flowchart. If the HPI alarm goes off, which entails both a sound and a flickering light, we ask the anesthesiologist to act upon this alarm immediately. Use of the study treatment flowchart ensures that the anesthesiologist has to think about the underlying cause. The HemoSphere with HPI software has a second screen with variables that provide information about the underlying cause of the predicted hypotension.

Timeline

• Start date: 2024-01-10
• Primary completion: 2024-12-10
• Completion: 2024-12-10
• First posted: 2024-04-04
• Last updated: 2025-01-14

Locations

1 site across 1 country: Greece