Surgical Strategy for Repair of Aortic Dissection: A Multicenter Registry
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 1,200
- 试验地点
- 2
- 主要终点
- Rate of mesenteric ischemia
研究概览
简要总结
Type A aortic dissection (TAAD) is a potentially life-threatening pathology associated with significant risk of mortality and morbidity. In acute forms of type A aortic dissection (TAAD) mortality is 50% by 24 h and 50% of patients die before reaching a specialist center. Rapid diagnosis and subsequent prompt surgical repair remain the primary goal for these patients.
In the last decade it has been observed that improvements in diagnostic techniques, initial management and increased clinical awareness have contributed to a substantial increase in the number of patients benefiting from a prompt diagnosis and undergoing surgery.However, survival after surgical repair has not yet reached optimal follow-ups and is burdened by high in-hospital mortality(16-18%)The main approach to acute type B non-complicated aortic dissection (TBAD) has always been to use medicines to control the patient's heart rate and blood pressure. However, recent findings suggest that a large number of patients treated for acute complicated (TBAAD) and non-complicated TBAD experience aortic complications, such as aneurysmal degeneration, at a later stage.
详细描述
For patients requiring surgical repair for a TAAD, there is still some disagreement regarding which factors should be considered during the preoperative evaluation, the best decision-making process to undertake that best assesses procedural risk, and how operative mortality can be predicted. Furthermore, the impact of different surgical strategies on outcomes remains unclear.This prospective study was designed to evaluate the impact of the center volume-outcome relationship and that on mortality which remain poorly understood. A better understanding of the determinants of outcome in patients undergoing surgery could support decision making, aid in the design of service delivery, and improve outcomes for surviving patients who are referred to specialized centers for treatment of aortic disease.Furthermore, the study aims to evaluate whether precise risk stratification can provide better patient counseling and be used for unit-surgeon benchmarking. Ultimately in the present study, we aimed to investigate outcome predictors in patients undergoing surgery for TAAD, including clinical and perioperative variables as well as to evaluate follow up beyond 15 years.TBAD occurring beyond the left subclavian artery (LSA) is classified in chronological order based on the timing of clinical presentation: acute (14 days or less), subacute (more than 14 days and less than or equal to 3 months), and chronic (more than 3 months).TBADs are also divided into complicated or non-complicated based on their initial clinical manifestation. Acute complicated TBAD is characterised by tearing of the aorta, pain, rapid expansion, hypertension, or blockages in the vasculature.Malperfusion syndrome is the most common complication, occurring in nearly 30% of cases. More than 30% of patients with mesenteric compromise following aortic dissection die .
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
- 否
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-day
Rate of abdominal pain with or without nausea and vomiting and rectal bleeding or bloody diarrhea
Operative Mortality (OM)
时间窗: 30-day
Patients who died within 30 days
Rate of permanent Neurologic Deficit (PND)
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 composite of Major Adverse Events (MAE)
时间窗: 30-day
Number of participants with MAE which will include the composite rate of myocardial infarction, cerebrovascular accident, need for dialysis, or need for tracheostomy according to Common Terminology Criteria for Adverse Events v4.0 (CTCAE)
Rate of perioperative Myocardial Infarction (MI)
时间窗: 30-day
Number of participants with MI based on fourth universal definition.
Rate of acute heart failure (AHF)
时间窗: 30-day and in-hospital mortality
Number of participants with postoperative AHF 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.
次要结局
- Rate of late survival(18-years)
- Rate of acute kidney injury(30-day)
- Rate of spinal Cord Injury (SCI)(30-day)
- Rate of Transient Neurologic Deficit (TND)(30-day)
- Rate of perioperative bleeding(30-day)
- Reoperation for bleeding(30-day)
- Rate of mechanical circulatory support(30-day)
- Rate of composite of Major Adverse Pulmonary Events (MAPE)(30-day)
- Rate of reintervention(18-years)
研究者
Francesco Nappi
Doctor
Centre Cardiologique du Nord