Rolled Pericardium Versus Cryopreserved Allograft to Treat Native or Prosthetic Aortic Infection

NCT06188819 | Unknown

• 1 other identifier: Infected Aorta
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

While surgery with anatomic reconstruction of prosthetic aortic infections and native infectious aortitis has become established over time, the ideal substitute is not clearly defined. The cryopreserved arterial allograft (AAC) recognized as resistant to infections not only presents availability problems making its use complicated, particularly in emergencies, with a certain number of long-term aneurysmal developments. The tubulized pericardium patch (PP), available in all cases, seems to give promising results in recent literature. The investigators propose a comparative study of these two substitutes in this indication. We carried out a two-center observational study including retrospectively from January 2010 to July 2023 all patients operated on for aortic prosthesis infection and native infectious aortitis with AAC reconstruction and prospectively PP patch reconstructions from July 2018 to July 2023. The diagnosis of infection was established according to the MAGIC criteria. The patients' preoperative comorbidities were collected to compare the groups. Postoperative morbidity and mortality was then compared. The medium-term evaluation consisted of comparing according to the Kaplan Meier method: postoperative mortality, permeability, reinfection rate, reoperation rate.

Conditions

Aortic Infections and Inflammations

Outcome Measures

Primary Outcomes (3)

• Mortality

  Number of patients death during post operative stay

  day 30 post operative

• Reintervention

  Rate of reintervention during post operative stay

  30 days, 6 months, 12 months, 24 months

• Post operative Major cardiovascular adverse events (MACE)

  Rate of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death

  day 30 post operative

Secondary Outcomes (2)

• Permeability

  30 days, 6 months, 12 months, 24 months

• Reinfection

  30 days, 6 months, 12 months, 24 months

Study Arms (2)

Cryopreserved arterial allograft

Aortic infection treated by cryopreserved arterial allograft

Procedure: Explantation of a previous aortic graft or endograft and reconstruction by arterial allograft or rolled pericardium

Rolled pericardium patch

Aortic infection treated by Pericardium patch rolled

Procedure: Explantation of a previous aortic graft or endograft and reconstruction by arterial allograft or rolled pericardium

Interventions

Explantation of a previous aortic graft or endograft and reconstruction by arterial allograft or rolled pericardium PROCEDURE

In situ reconstruction with explantation of the infected graft or endograft and reconstruction by allograft or pericardium

Cryopreserved arterial allograft; Rolled pericardium patch

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients operated on for a native infection or an aortic prosthesis who had pericardium or allograft reconstruction

You may qualify if:

• All aortic intervention performed for native aortic infection reconstruction with patch or allograft
• All aortic intervention performed for infected graft reconstruction with patch or allograft

Sponsors & Collaborators

• University Paul Sabatier of Toulouse: lead
• LUCAS BATISTELLA, MD: collaborator
• Kheira hireche, MD: collaborator
• Ludovic CANAUD, MD PhD: collaborator

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 18, 2023
• First Posted: January 3, 2024
• Study Start: January 1, 2010
• Primary Completion: January 2, 2010
• Study Completion: June 15, 2024
• Last Updated: January 10, 2024

Record last verified: 2024-01