Searching Optimal Tailored Strategy for Repair of Acute Type A Acute 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 Transient Neurologic Deficit (TND)
研究概览
简要总结
Acute type A aortic dissection (TAAD) persists as a clinicopathologic entity with high lethality in the current era. Several procedures are presently used to repair the TAAAD. The objective of this study is to analyze two groups of individuals using a conservative approach through root-sparing and hemiarch techniques in patients who are hospitalized in higher-risk clinical conditions or more aggressive procedures such as root replacement and total arch replacement in low-risk patients.
详细描述
The target population enrolled in the registry includes patients with TAAAD.The high volume of patients that will be enrolled in this registry will receive proximal and distal aortic repair in elective, urgent or emergency clinical condition. Efforts of investigators will be concentrated in TAAAD repair using a conservative approach of root preservation and hemiarch reconstruction in the majority of patients who will be referred in critical clinical condition. High-risk patients with older age or more comorbidities had more conservative repairs to limit surgical insult to these complicated patients. Total arch reconstruction and root replacement will be optional procedures for specific subgroups of patients who may benefit from a more complex index finger operation without incurring additional immediate risk.
Investigators hope to demonstrate a reduction in operative mortality and an improvement in early and late outcomes. The experience of investigators will be summarized in an algorithm for TAAAD repair with an analysis of early morbidity and mortality, as well as late survival and no reoperation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •TAAD or intramural hematoma involving the ascending aorta
- •Patients aged > 18 years
- •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.
研究组 & 干预措施
Conservative Type A Acute Aortic Dissection Repair (TAAAD-R)
All conservative TAAAD-R will be performed through a median sternotomy. The conservative TAAAD-R will include patients receiving valve-sparing root procedures and recipients of ascending aortic root sparing replacement if the intima separation extended into the sinuses resulting in commissural collapse.When necessary, the hemiarch technique will be used with a limited extension of the conservative procedure by resection of all the aortic tissue up to the left common carotid artery and which will be dictated according to the presentation of the lesion.
干预措施: Conservative TAAAD-R (Procedure)
Conservative Type A Acute Aortic Dissection Repair (TAAAD-R)
All conservative TAAAD-R will be performed through a median sternotomy. The conservative TAAAD-R will include patients receiving valve-sparing root procedures and recipients of ascending aortic root sparing replacement if the intima separation extended into the sinuses resulting in commissural collapse.When necessary, the hemiarch technique will be used with a limited extension of the conservative procedure by resection of all the aortic tissue up to the left common carotid artery and which will be dictated according to the presentation of the lesion.
干预措施: Extensive TAAAD-R (Procedure)
Extensive Type A Acute Aortic Dissection Repair (TAAAD-R)
All extensive TAAAD-R will be performed through a median sternotomy.The extensive TAAAD-R will include patients receiving replacement of the aortic root and total arch replacement procedures (TARP)
干预措施: Extensive TAAAD-R (Procedure)
Extensive Type A Acute Aortic Dissection Repair (TAAAD-R)
All extensive TAAAD-R will be performed through a median sternotomy.The extensive TAAAD-R will include patients receiving replacement of the aortic root and total arch replacement procedures (TARP)
干预措施: Conservative TAAAD-R (Procedure)
结局指标
主要结局
Rate of Transient Neurologic Deficit (TND)
时间窗: 30-day
Number of participants who will complicate postoperatively with episode of TND which will include complication rate such as confusion, delirium, agitation
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.
Operative Mortality (OM)
时间窗: 30-day
Patients who died within 30 days
次要结局
- Late survival(10 years)
- Rate of spinal Cord Injury (SCI)(30-day)
- Rate of composite of Major Adverse Events (MAE)(30-day)
- Rate of reintervention(10 years)
- Rate of perioperative Myocardial Infarction (MI)(30-day)
- Rate of composite of Major Adverse Pulmonary Events (MAPE)(30-day)
研究者
Francesco Nappi
Director
Centre Cardiologique du Nord