Global Hypoperfusion Index (GHI) Algorithm

by Edwards Lifesciences  · Based in United States → — Predicting and managing global hypoperfusion events in critical care.
Anesthesiology Critical Care Emergency Medicine

Contact for pricing
Regulatory Status Disclosed

Overview

The Global Hypoperfusion Index (GHI) Algorithm is an advanced software feature developed by Edwards Lifesciences to provide clinicians with physiological insight into a patient’s likelihood of experiencing a global hypoperfusion event. Utilizing a machine-learning model based on real-time patient health data, the algorithm generates an index ranging from 0 to 100, where higher values indicate an increased probability of an event. It is designed to predict these events, defined as mixed venous oxygen saturation (SvO2) dropping to 60% or below for at least one minute, approximately 10-15 minutes before they occur. The GHI algorithm is intended for use in surgical and non-surgical patients receiving advanced hemodynamic monitoring with the Swan-Ganz catheter within a critical care environment. It serves as an adjunctive tool, offering additional information for clinical review and identifying patients at low risk for deterioration, but therapeutic decisions should not be made based solely on its predictions.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Predicts global hypoperfusion events 10-15 minutes in advance
  • Generates an index (0-100) indicating the likelihood of an event
  • Utilizes a machine-learning model based on real-time patient health data
  • Alerts clinicians when risk reaches a predefined threshold
  • Intended for use with Swan-Ganz catheter and compatible monitoring platforms (e.g., HemoSphere Alta)
  • Provides adjunctive information for clinical review, not for sole therapeutic decisions

Use Cases

  • Proactive identification of patients at risk for global hypoperfusion
  • Assisting clinicians in critical care environments to anticipate hemodynamic instability
  • Monitoring surgical and non-surgical patients receiving advanced hemodynamic monitoring

What Physicians Need to Know

Evidence Base
The GHI Algorithm was developed by Edwards Lifesciences, LLC, and received FDA premarket notification on July 26, 2023. Its verification involved prospective analyses of retrospective clinical data from multiple independent datasets, along with functional and performance testing, software and algorithm verification and validation, and bench studies. The algorithm's development and validation included the collection of patient waveforms. It was compared to predicate devices like the Acumen Hypotension Prediction Index (HPI) software feature and the CLEWICU System.
Clinical Validation Studies
Clinical validation involved prospective analyses of retrospective clinical data from diverse patients over 18 years old undergoing surgical procedures with invasive monitoring. These analyses aimed to verify the safety and performance of the device, with all performance verification and validation activities successfully demonstrating that the device meets predetermined design and performance specifications.
Alert Fatigue Management
The algorithm is designed to alert clinicians when a patient's risk reaches a predefined threshold, providing an average of 10-15 minutes lead time before a global hypoperfusion event (SvO2 u2264 60% for at least one minute) occurs. This predictive window allows for timely clinical review and action, potentially mitigating the urgency of alerts.
Override Rate Data
Specific override rate data for the GHI Algorithm is not publicly available in the provided information.
Differential Diagnosis Support
The GHI Algorithm is a predictive tool focused on identifying the likelihood of a global hypoperfusion event and future hemodynamic instability. It provides physiological insight and additional information regarding predicted risk for clinical deterioration, rather than offering a broad differential diagnosis for underlying conditions.
Clinical Workflow Integration
The GHI Algorithm is intended for use in a critical care environment by qualified personnel or trained clinicians in a hospital setting. It functions as a software feature on a compatible monitoring platform, implying integration with existing advanced hemodynamic monitoring systems, specifically those utilizing a Swan-Ganz catheter.
Decision Audit Trail
Details regarding a specific decision audit trail feature for the GHI Algorithm are not explicitly mentioned in the available information.
Physician Tip

The Global Hypoperfusion Index (GHI) Algorithm serves as an adjunctive tool to predict the likelihood of a global hypoperfusion event 10-15 minutes in advance. Physicians should integrate GHI insights with comprehensive clinical assessment, patient history, and other monitoring parameters. The index (0-100) provides a risk indication, but therapeutic decisions should never be based solely on the GHI. Utilize the predictive window to proactively review patient status and consider interventions, rather than reacting to an event already in progress. Remember that the algorithm is designed for patients receiving advanced hemodynamic monitoring with a Swan-Ganz catheter in critical care.

The GHI Algorithm is designed as a software feature for compatible monitoring platforms, indicating its integration into existing advanced hemodynamic monitoring systems, likely those provided by Edwards Lifesciences, LLC. It leverages real-time patient health data from these systems to generate its predictions. Seamless integration with such platforms is crucial for its functionality within the critical care workflow.

Details

Category Clinical Decision Support & Reference, Triage & ER/ICU AI
Pricing Contact for pricing
DeploymentIntegrated into compatible advanced hemodynamic monitoring platforms, such as the HemoSphere Alta™ Advanced Monitoring Platform.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Yes AI-estimated

The Global Hypoperfusion Index (GHI) Algorithm received FDA premarket notification (K231038) on July 26, 2023. It is intended for use in surgical or non-surgical patients receiving advanced hemodynamic monitoring with the Swan-Ganz catheter in a critical care environment, providing physiological insight into the likelihood of a global hypoperfusion event.

Integrations
EHR Not specified
Specialties Anesthesiology, Critical Care, Emergency Medicine

What the Web Says

The Global Hypoperfusion Index (GHI) Algorithm, developed by Edwards Lifesciences, is designed for use in critical care settings to predict a patient's risk of hemodynamic instability and global hypoperfusion events. It utilizes a machine-learning model based on real-time patient health data, generating an index from 0 to 100, with higher values indicating a greater likelihood of an event. The algorithm aims to alert clinicians 10-15 minutes before a significant drop in mixed venous oxygen saturation (SvO2) occurs, allowing for timely intervention.

Overall: Positive

Strengths

  • Predicts risk of global hypoperfusion events 10-15 minutes in advance, allowing for early intervention.
  • Aids in predicting a patient's risk of hemodynamic instability.
  • Utilizes a machine-learning model based on real-time patient health data.
  • Generates an easy-to-understand index (0-100) for risk assessment.
  • Intended for use in both surgical and non-surgical patients receiving advanced hemodynamic monitoring.
  • Provides additional information for clinical decision-making, not as a sole basis for therapeutic decisions.

Limitations

  • Intended for use only by qualified personnel or trained clinicians in a hospital setting.
  • Not intended as the sole basis for therapeutic decisions.
  • Requires advanced hemodynamic monitoring with a Swan-Ganz catheter.
  • Limited information available from independent tech reviewers, G2, or Capterra.
  • Reddit discussions on cerebral hypoperfusion are general and do not specifically mention the GHI Algorithm.
  • Further validation in larger prospective studies is needed to confirm its role in routine practice.

Based on reviews from: Medical News Observer, Edwards Lifesciences, LLC (FDA Premarket Notification), MDPI (Hypoperfusion Intensity Ratio as an Independent Predictor of Functional Outcome After Mechanical Thrombectomy for Large Vessel Occlusion Stroke), PubMed (New insights on the predictive value of hypoperfusion intensity ratio in thrombectomy: an updated systematic review and meta-analysis with multiple cut-offs), MDPI (Hypoperfusion Intensity Ratio as a Surrogate of Collateral Scoring on CT Angiogram in Large Vessel Stroke), PubMed (Hypoperfusion index ratio and pretreatment with intravenous thrombolysis are independent predictors of good functional outcome in acute ischemic stroke patients with large vessel occlusion treated with acute reperfusion therapies), RapidAI (Hypoperfusion intensity ratio (HIR) and CBV index predict ICAS-related LVO: What stroke teams should know), American Heart Association Journals (Hypoperfusion Intensity Ratio Is Correlated With the Risk of Parenchymal Hematoma After Endovascular Stroke Treatment), PubMed (Global White Matter Hypoperfusion on CT Predicts Larger Infarcts and Hemorrhagic Transformation after Acute Ischemia), PMC (Hypoperfusion Intensity Ratio as a Surrogate of Collateral Scoring on CT Angiogram in Large Vessel Stroke), Reddit, MDPI (Correlation between Hypoperfusion Intensity Ratio and Functional Outcome in Large-Vessel Occlusion Acute Ischemic Stroke: Comparison with Multi-Phase CT Angiography), ResearchGate (Hypoperfusion Intensity Ratio as a Surrogate of Collateral Scoring on CT Angiogram in Large Vessel Stroke), PMC (Hypoperfusion Intensity Ratio as an Independent Predictor of Functional Outcome After Mechanical Thrombectomy for Large Vessel Occlusion Stroke), Refubium - Freie Universitu00e4t Berlin (A novel approach for assessing hypoperfusion in stroke using spatial independent component analysis of restingu2010state fMRI), PubMed (Association of hypoperfusion intensity ratio and cerebral blood volume Index with good outcome in patients transferred for thrombectomy), PMC (Evaluating the prognostic impact of hypoperfusion intensity ratio in acute ischemic stroke patients undergoing early-phase endovascular thrombectomy), ResearchGate (PDF) Hypoperfusion Intensity Ratio as an Independent Predictor of Functional Outcome After Mechanical Thrombectomy for Large Vessel Occlusion Stroke

Last updated: 2026-07-17

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Press & Coverage

Medical News Observer
AI/ML: The Global Hypoperfusion Index (GHI) Algorithm
Edwards Lifesciences developed the Global Hypoperfusion Index (GHI) Algorithm, which received FDA premarket notification on July 26, 2023. The algorithm uses a machine-learning model to predict a patient's likelihood of experiencing a global hypoperfusion event 10-15 minutes in advance, assisting clinicians in critical care settings.
2023-10
PMC (PubMed Central)
The landscape of artificial intelligence-enabled medical devices in the EU and the US intended for intensive care units
This article discusses the Global Hypoperfusion Index (GHI) Algorithm (K231038, 2023) as an FDA-approved AI-enabled medical device. It analyzes hemodynamic data from Swan-Ganz catheter monitoring to predict global hypoperfusion events in surgical and non-surgical patients.
2024-02
FDA Radiology AI
Global Hypoperfusion Index (GHI) Algorithm | FDA Radiology AI
The Global Hypoperfusion Index (GHI) Algorithm, developed by Edwards Lifesciences, LLC, received FDA approval on July 26, 2023. It is a software tool used on compatible advanced monitoring platforms to predict the risk of a global hypoperfusion event.
2023-07
accessdata.fda.gov
Edwards Lifesciences, LLC - K231038
This FDA premarket notification document details the Global Hypoperfusion Index (GHI) software feature, intended for use with the Swan-Ganz catheter in critical care to provide physiological insight into a patient's likelihood of a global hypoperfusion event. The algorithm predicts events 10-15 minutes before mixed venous oxygen saturation (SvO2) reaches 60%.
2023-07
BD
HemoSphere Altau2122 Monitor
The HemoSphere Altau2122 Monitor integrates the Global Hypoperfusion Index (GHI) algorithm to predict SvOu2082 desaturations up to 15 minutes in advance. This advanced monitoring platform is designed to help detect hemodynamic instability before it occurs.
unknown
EBPOM Ireland 2024 - Abstract booklet
Global Hypoperfusion Index (GHI) Algorithm: Predicting future global hypoperfusion using the Swan Ganz catheter
This abstract from EBPOM Ireland 2024 highlights the Global Hypoperfusion Index (GHI) Algorithm as a tool for predicting future global hypoperfusion using the Swan-Ganz catheter. The authors include researchers from Edwards Lifesciences and various universities.
2024-09
accessdata.fda.gov
Edwards Lifesciences, LLC - K242451
This FDA document further discusses the Global Hypoperfusion Index (GHI) algorithm, stating its intention for use in surgical or non-surgical patients receiving advanced hemodynamic monitoring with the Swan-Ganz catheter. It provides additional information regarding predicted future risk for clinical deterioration.
2024-12
FDA.report
Edwards Lifesciences, LLC - K233075
This regulatory document from the FDA reiterates the GHI algorithm's function in providing physiological insight into a patient's likelihood of future hemodynamic instability, specifically the risk of a global hypoperfusion event within 10-15 minutes.
2023-10

Videos

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Frequently Asked Questions

The GHI Algorithm helps clinicians predict a patient's likelihood of experiencing a global hypoperfusion event, defined as mixed venous oxygen saturation (SvO2) dropping to 60% or below, approximately 10-15 minutes before it occurs. It generates an index from 0 to 100, with higher values indicating increased risk, enabling earlier intervention in critical care settings.
Yes, Edwards Lifesciences, LLC received FDA premarket notification (510(k) clearance) for the Global Hypoperfusion Index (GHI) Algorithm on July 26, 2023. It is classified as a Class II medical device, and its use requires compliance with FDA regulations including registration, labeling, and medical device reporting.
The GHI Algorithm provides a predictive, real-time assessment of hemodynamic instability using machine learning and Swan-Ganz catheter data, offering a lead time before an event. While traditional markers like lactate or base deficit indicate existing hypoperfusion, and the related Hypotension Prediction Index (HPI) predicts hypotension and its mechanisms, GHI specifically focuses on predicting global hypoperfusion events.
Specific pricing for the GHI Algorithm is not readily available in public search results, as it is typically integrated into advanced hemodynamic monitoring platforms. Costs would likely be part of the overall investment in such monitoring systems and associated consumables. For related predictive algorithms, studies have shown varying device costs but similar total costs compared to standard care.
The GHI Algorithm is intended for adjunctive use only and should not be the sole basis for therapeutic decisions. It requires advanced hemodynamic monitoring with a Swan-Ganz catheter, limiting its applicability to patients undergoing such invasive monitoring. The predictions are for reference, and clinical judgment remains paramount.
The GHI Algorithm is intended for surgical and non-surgical adult patients in a critical care environment who are receiving advanced hemodynamic monitoring. Specifically, it requires data from a Swan-Ganz catheter to function effectively.
The GHI Algorithm can predict a global hypoperfusion event, defined as SvO2 dropping to 60% or below, on average 10-15 minutes before it occurs. This lead time is clinically significant as it allows qualified personnel or trained clinicians time for appropriate clinical review and proactive intervention to potentially mitigate adverse outcomes.

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Suggest an Edit → | Last Verified: 2026-04-18 | First Added: 2026-04-18
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