Searching Optimal Tailored Strategy for Repair of Acute Type A Acute Aortic Dissection
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Aortic Dissection
- Sponsor
- Centre Cardiologique du Nord
- Enrollment
- 900
- Locations
- 1
- Primary Endpoint
- Rate of Transient Neurologic Deficit (TND)
- Status
- Enrolling By Invitation
- Last Updated
- last year
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Francesco Nappi
Director
Centre Cardiologique du Nord
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Rate of Transient Neurologic Deficit (TND)
Time Frame: 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)
Time Frame: 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)
Time Frame: 30-day
Patients who died within 30 days
Secondary Outcomes
- 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)