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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Aortic Infections and Inflammations
• Intervention / Treatment: Procedure: Explantation of a previous aortic graft or endograft and reconstruction by arterial allograft or rolled pericardium

• Study Type: Observational
• Enrollment (Actual): 150

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• no

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; In situ reconstruction with explantation of the infected graft or endograft and reconstruction by allograft or 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; In situ reconstruction with explantation of the infected graft or endograft and reconstruction by allograft or pericardium

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Permeability	Rate of reintervention for occlusion of the patch or the allograft	30 days, 6 months, 12 months, 24 months
Reinfection	Rate of reintervention for infection of the patch or the allograft	30 days, 6 months, 12 months, 24 months

Collaborators and Investigators

• Sponsor: University Paul Sabatier of Toulouse
• Collaborators: LUCAS BATISTELLA, MD; Kheira hireche, MD; Ludovic CANAUD, MD PhD

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Actual): January 2, 2010
• Study Completion (Estimated): June 15, 2024

Study Registration Dates

• First Submitted: December 18, 2023
• First Submitted That Met QC Criteria: December 18, 2023
• First Posted (Actual): January 3, 2024

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Inflammation; Infections; Communicable Diseases
• Other Study ID Numbers: Infected Aorta

Drug and device information, study documents

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