Early Complication and Outcomes in Surgical vs no Surgical Involvement of Aortic Arch in Type A Aortic Dissection
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 900
- 试验地点
- 2
- 主要终点
- Rate of mesenteric ischemia
研究概览
简要总结
Acute Stanford type A aortic dissection (TAAD) is a life-threatening clinical status requiring surgery that is usually performed as a salvage procedure.We planned a multicenter study to evaluate the balance between the patient's condition and those therapeutic strategies that may limit the risk of late adverse events in patients who will be underwent surgery for appropriate management of TAAD
详细描述
Substantial evidence has suggested a decrease of early mortality during the last years, however recently the Nordic Consortium for Acute Type A Aortic Dissection registry recorded 18% of 30-day mortality after surgery for ATAAD. Similarly, the prospective German Registry for Acute Aortic Dissection Type A confirmed this data reporting a 30-day mortality of 16.9%. Again, results from recent analysis of the Society of Thoracic Surgeon database that report 7353 procedures from 2014 and 2017 for acute TAAD revealed a 30-day mortality of 17%. Understanding the balance between the patient's conditions which may not allow extensive procedure and those treatment strategies which may limit the risk of late adverse events in patients who remain alive long after the surgery is essential for an appropriate management of ATAAD. The best treatment option in patients with ATAAD is dictated by the balance between patient conditions that may not allow for extensive procedures and those more conservative treatment strategies that limit the risk of late adverse events in patients who remain alive long after surgery. surgery. However, previous evidence from large series of patients do not provide information on the long-term durability of these procedures.
Here investigators planned a multicenter study to evaluate the contemporary early outcomes and duration of different surgical strategies for 15-year acute ATAAD in a large study population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged > 18 years
- •TAAD or intramural hematoma involving the ascending aorta
- •Symptoms started within 7 days from surgery
- •Primary surgical repair of acute TAAD
- •Any other major cardiac surgical procedure concomitant with surgery for TAAD.
排除标准
- •Patients aged < 18 years
- •Onset of symptoms > 7 days from surgery
- •Prior procedure for TAAD
- •Concomitant endocarditis;
- •TAAD secondary to blunt or penetrating chest trauma.
结局指标
主要结局
Rate of mesenteric ischemia
时间窗: 30-days
Rate of abdominal pain with or without nausea and vomiting and rectal bleeding or bloody diarrhea
Rate of acute kidney injury
时间窗: 30-days
Number of participants with postoperative change in serum creatinine concentration. Severity will be stratified on the basis of number of participants with the KDIGO (Kney Disease Improving Global Outcomes) criteria.
Operative Mortality (OM)
时间窗: 30-day
Patients who died within 30 days
Rate of acute heart failure
时间窗: 30-day
Number of participants with postoperative heart failure who will require prolonged use of concentration of inotropes for a period greater than 24 h and/or the insertion of any mechanical circulatory support device.
Stroke
时间窗: 30-day
Number of participants with acute episode of a focal or global neurological deficit. Rates of alteration of degree of consciousness, hemiplegia, hemiparesis, numbness or sensory loss affecting one side of the body, dysphasia or aphasia, hemianopsia, amaurosis fugax. To consider rate of other neurologic signs or symptoms consistent with stroke duration of focal or global neurologic deficit greater than 24 hours.
Rate of global brain ischemia
时间窗: 30-days
Rate of diffuse hypoxic damage as diagnosed at brain imaging and electroencephalography.
次要结局
- Rate of paraplegia/paraparesis(30-day)
- Late outcomes(18 years)
- Rate of perioperative bleeding(30-day)
- Rate of reoperation for bleeding(30-day)
- Rate of mechanical circulatory support(30-day)
研究者
Francesco Nappi
Director
Centre Cardiologique du Nord