Superior Vena Cava Reconstruction in Patients on Hemodialysis (Hemodialysis)

The treatment objective for patients with SVC syndrome secondary to both malignant and benign etiologies is to reduce the elevated central venous pressures.1 However, the strategies are contingent upon the underlying disease process. Thus the management of SVC syndrome ranges from medical or supportive care to surgical bypass,3 and it is important for physicians to understand the varied treatment modalities of this potentially life-threatening disease.17 Fortunately, the overwhelming majority of patients with SVC syndrome secondary to benign causes develop a physiologic compensation for the obstruction that can be treated with anticoagulation and endovascular modalities. Intervention for symptomatic relief may not be required.1 An endovascular approach is the current standard of care to relieve SVC obstruction due to malignancy to obtain prompt relief of the rapidly emerging symptoms and improve quality of life,3 keeping in mind the short life expectancy of these patients. The role of endovascular therapy in SVC syndrome of nonmalignant etiology is undecided because the long-term durability of this treatment method remains to be assessed.

Study Overview

• Status: Completed
• Conditions: Superior Vena Cava Syndrome
• Intervention / Treatment: Procedure: Superior vena cava reconstruction

Detailed Description

This case study will retrospectively review all SVC syndrome and/or occlusion procedures since January 2009. All patients were given adequate informed consent about the procedure and its benefits and complications.

Definitions of clinical outcomes will adhere to the Subcommittee on Reporting Standards in Venous disease.27 Risk factors and outcomes of these procedures will be retrospectively analyzed. Data collected included preoperative patient demographics, clinical status, noninvasive and invasive imaging, operative procedural details, post-operative complications, post-procedural imaging surveillance, adjunctive/re-intervention procedures, clinical outcome during follow-up, and mortality. Primary endpoints will be clinical outcome and patency. Secondary endpoints will be re-intervention rate and death within 30 days.

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75203
      • Methodist Dallas Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent SVC bypass procedures from January 2010 to June 2013 at Methodist Dallas Medical Center will be screened for participation in the study.

Description

Inclusion Criteria:

• Age ≥ 18 years
• Presence of SVC syndrome or SVC occlusion
• Presence of ESRD on hemodialysis
• Presence of upper extremity or neck access, either catheter or surgical fistula
• Patients who have received endovenous or open bypass reconstruction of the SVC secondary to SVC syndrome or SVC occlusion

Exclusion Criteria:

• Patients who have not undergone endovenous or open bypass reconstruction of the SVC secondary to SVC syndrome or SVC occlusion

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical outcome and patency	To report findings in patients with ESRD on hemodialysis who underwent SVC reconstruction	Upto 30 days

Collaborators and Investigators

• Sponsor: Methodist Health System
• Investigators: Principal Investigator: Robert Feldtman, M.D., The Methodist Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2014
• Primary Completion (Actual): May 6, 2022
• Study Completion (Actual): May 6, 2022

Study Registration Dates

• First Submitted: August 12, 2019
• First Submitted That Met QC Criteria: November 18, 2020
• First Posted (Actual): November 19, 2020

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Superior Vena Cava Syndrome
• Other Study ID Numbers: 2013.00.642.A

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