Rolled Pericardium Versus Cryopreserved Allograft to Treat Native or Prosthetic Aortic Infection
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 150
- 主要终点
- Reintervention
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
结局指标
主要结局
Reintervention
时间窗: 30 days, 6 months, 12 months, 24 months
Rate of reintervention during post operative stay
Post operative Major cardiovascular adverse events (MACE)
时间窗: day 30 post operative
Rate of nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death
Mortality
时间窗: day 30 post operative
Number of patients death during post operative stay
次要结局
- Reinfection(30 days, 6 months, 12 months, 24 months)
- Permeability(30 days, 6 months, 12 months, 24 months)
研究者
Aurélien Hostalrich
Clinical Professor
University Paul Sabatier of Toulouse
