Thoracic Epidural Anesthesia Reduces Mortality and Rehospitalization for Patients With Heart Failure With Reduced Ejection Fraction

Thoracic Epidural Anesthesia Reduces Mortality and Rehospitalization for Patients With Heart Failure With Reduced Ejection Fraction：a Retrospective Matched Case-control Study

Despite significant scientific breakthrough in management, patients with heart failure with reduced ejection fraction (HFrEF) remain high morbidity and mortality, with a 5-year survival rate of 25% after hospitalization for HFrEF. The autonomic nervous system (ANS), particularly the sympathetic nervous system (SNS), plays a critical compensatory role in maintaining cardiovascular homeostasis in the failing heart. This is critical given the huge unmet need for novel treatment strategies for HFrEF.

Thoracic epidural anesthesia (TEA), the infusion of anesthetic agents (eg, lidocaine or ropivacaine) into the epidural space, is used to achieve sympathetic block at the T1 to T4 levels in thoracic and abdominal surgical procedures. Since 1995, Professor Liu Fengqi has pioneered the use of TEA to treat end-stage HFrEF and achieved surprising results. TEA could reduce the enlarged heart cavity, halt and reverse cardiac remodeling, and improve cardiac systolic and diastolic function. Currently, thousands of HFrEF patients have received TEA procedure. However, it is unclear whether TEA could positively impact the clinical outcomes of patients with HFrEF.

Study Overview

• Status: Completed
• Conditions: Heart Failure With Reduced Ejection Fraction; Thoracic Epidural Anesthesia
• Intervention / Treatment: Combination product: TEA plus GDMT; Drug: GDMT

• Study Type: Interventional
• Enrollment (Actual): 1840
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• The present study was a retrospective, observational, matched case-control study of 1,840 consecutive inpatients, in New York Heart Association functional class II-IV with a left ventricular ejection fraction (LVEF) ≤40%, who were hospitalized from July 2013 to August 2019.

Exclusion Criteria:

• Patients were excluded because of insufficient patient information, refusal to participate, or loss to follow-up by telephone. In patients with multiple hospitalizations during the time period, the first hospitalization was utilized in the analysis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GDMT plus TEA; The patients received maximally tolerated guideline-directed medical therapy (GDMT) plus TEA. Thoracic epidural anesthesia (TEA), the infusion of anesthetic agents (eg, lidocaine or ropivacaine) into the epidural space, is used to achieve sympathetic block at the T1 to T4 levels in thoracic and abdominal surgical procedures.	Combination product: TEA plus GDMT; Thoracic epidural anesthesia (TEA), the infusion of anesthetic agents (eg, lidocaine or ropivacaine) into the epidural space, is used to achieve sympathetic block at the T1 to T4 levels in thoracic and abdominal surgical procedures. Since 1995, Professor Liu Fengqi has pioneered the use of TEA to treat end-stage HFrEF and achieved surprising results. TEA could reduce the enlarged heart cavity, halt and reverse cardiac remodeling, and improve cardiac systolic and diastolic function. Currently, thousands of HFrEF patients have received TEA procedure. All the patients received maximally tolerated guideline-directed medical therapy (GDMT).
Active Comparator: GDMT; The patients received maximally tolerated GDMT.	Drug: GDMT; All the patients received maximally tolerated guideline-directed medical therapy (GDMT) alone.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of heart failure mortality in the patients with HFrEF	Rate of heart failure mortality in the patients with HFrEF	8.5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of heart failure rehospitalization in the patients with HFrEF	Rate of heart failure rehospitalization in the patients with HFrEF	8.5 years

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Harbin Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2013
• Primary Completion (Actual): August 31, 2019
• Study Completion (Actual): August 31, 2023

Study Registration Dates

• First Submitted: September 28, 2023
• First Submitted That Met QC Criteria: September 28, 2023
• First Posted (Actual): October 5, 2023

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: TEA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No