Evaluating the Impact of Psoas Muscle Size, Composition, and Clinical Frailty on Long-term Outcomes Following Elective Endovascular Aneurysm Repair

March 7, 2025 updated by: National Taiwan University Hospital

Evaluating the Impact of Psoas Muscle Size, Composition, and Clinical Frailty on Long-term Outcomes Following Elective Endovascular Aneurysm Repair: a Multicenter Retrospective Study

Sarcopenia, which is characterized by the progressive loss of skeletal muscle mass and strength, has emerged as a significant prognostic biomarker in the field of vascular surgery, particularly regarding endovascular aneurysm repair (EVAR). This article delves into the implications of sarcopenia on the outcomes of EVAR, emphasizing its predictive value for long-term survival and potential as a tool for patient risk stratification.

Recent research suggests that sarcopenia could be used as a biomarker for prognosis. A systematic review and meta-analysis have underscored sarcopenia's negative prognostic value for survival during long-term follow-up post-EVAR. The presence of sarcopenia, as determined by decreased core muscle area in axial abdominal computed tomography (CT) scans, has been widely discussed as a predictor of outcomes in patients undergoing EVAR.1

Moreover, studies have consistently reported an association between sarcopenia and increased mortality and adverse outcomes following EVAR.2 For instance, a retrospective review investigating sarcopenia as a method to predict 1-year survival in patients undergoing EVAR found a significant increase in overall mortality among patients with the lowest quartile of normalized total psoas cross-sectional area (nTPA).2 Therefore, researchers suggested that physicians can use sarcopenia for risk stratification and patient selection before an EVAR. The evaluation of sarcopenia from preoperative CT scans can assist clinicians in identifying EVAR candidates who may be less likely to benefit from the procedure.2 This objective radiographic finding offers a standardized method for patient selection, which could be particularly useful in telemedicine and remote patient evaluation.

The integration of sarcopenia assessment into the preoperative evaluation of patients considered for EVAR can revolutionize the approach to managing abdominal aortic aneurysms (AAA). By providing a reliable biomarker for risk stratification, sarcopenia can enable a more personalized treatment plan, potentially improving patient outcomes and optimizing healthcare resources. Nonetheless, the majority of the studies were conducted among Western populations. The implications are questionable for Taiwan patients. This study aims to fill the gap and to analyze the sarcopenia and its impact on patient outcomes following EVAR in Taiwan

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

525

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • New taipei city, Taiwan, 100
        • National Taiwan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

The AAA patients undergoing EVAR procedures

Description

Inclusion Criteria:

  • The AAA patients undergoing EVAR procedures

Exclusion Criteria:

  • The AAA patients undergoing open surgery procedures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
The AAA patients undergoing EVAR procedures
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Death
Time Frame: From enrollment to the end at 8 years
The social security death was queried to confirm all deaths and survey patients lost to follow-ups
From enrollment to the end at 8 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical outcomes
Time Frame: From enrollment to the end at 8 years
Clinical adverse events, number of participants with cardiac events, number of participants with cerebrovascular events, number of participants with amputation events, number of participants with accesssite events, number of participants with reintervention events.
From enrollment to the end at 8 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2024

Primary Completion (Actual)

January 3, 2025

Study Completion (Actual)

March 3, 2025

Study Registration Dates

First Submitted

March 3, 2025

First Submitted That Met QC Criteria

March 3, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 7, 2025

Last Verified

August 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Endovascular Aneurysm Repair (EVAR)

Clinical Trials on No Intervention: Observational Cohort

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