Clinical trial NCT05927090: Outcomes of Aortic Dissection Repair
Official title: Surgical Strategy for Repair of Aortic Dissection: A Multicenter Registry
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Type A Aortic Dissection
Ascending Aortic Dissection
Aortic Diseases
Aortic Arch
Aortic Valve Insufficiency
Aortic Root Dissection
Aortic Root Dilatation
Type B Aortic Dissection
Keywords: DeBakey type I Dissection
DeBakey type II Dissection
Type A Acute Aortic Dissection (TAAAD)
Root-Sparing Replacement
Ascending Aorta Replacement
Partial Arch Repair
Hemiarch Procedures
Total Arch Replacement (TARP)
Frozen Elephant Trunk (FET) Hemiarch Procedures
Type B Acute Aortic Dissection (TBAAD)
Type B non acuteAortic Dissection (TBAD)
Lead sponsor: Centre Cardiologique du Nord
Sponsor class: OTHER
Collaborators: name: Henri Mondor University Hospital
name: Universita degli Studi di Genova
name: Pitié-Salpêtrière Hospital
name: Ospedale San Camillo, Rome, Italy
name: Campus Bio-Medico University
First posted: 2023-07-03
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The STAAD study is a prospective multicenter registry including patients who will underwent surgery for acute TAAD at 6 centers of cardiac surgery located in 2 European countries and Japan (3 France, 2 Italy and 1 Hokkaido ). Data will be prospectively collected from patients (conservative vs estensive Type A aortic dissection repair) who will be treated during the study period. In addition, the aim will be to gather further data for future clinical research on this topic. Preoperative and postoperative variables will be included during in-hospital stay and follow-up data instead they will be included on subsequent encounters for all other patients who will be hospitalized.

Brief summary: 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.

Detailed description: 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 .

Eligibility criteria: Inclusion Criteria:

* 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.

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.

Primary outcomes:
measure: Operative Mortality (OM)
timeFrame: 30-day
measure: Rate of mesenteric ischemia
timeFrame: 30-day
measure: Rate of permanent Neurologic Deficit (PND)
timeFrame: 30-day
measure: Rate of composite of Major Adverse Events (MAE)
timeFrame: 30-day
measure: Rate of perioperative Myocardial Infarction (MI)
timeFrame: 30-day
measure: Rate of acute heart failure (AHF)
timeFrame: 30-day and in-hospital mortality
Secondary outcomes:
measure: Rate of Transient Neurologic Deficit (TND)
timeFrame: 30-day
measure: Rate of spinal Cord Injury (SCI)
timeFrame: 30-day
measure: Rate of acute kidney injury
timeFrame: 30-day
measure: Rate of perioperative bleeding
timeFrame: 30-day
measure: Reoperation for bleeding
timeFrame: 30-day
measure: Rate of mechanical circulatory support
timeFrame: 30-day
measure: Rate of composite of Major Adverse Pulmonary Events (MAPE)
timeFrame: 30-day
measure: Rate of reintervention
timeFrame: 18-years
measure: Rate of late survival
timeFrame: 18-years
Other outcomes:
measure: Rate of urgent procedure
timeFrame: 30-day
measure: Rate of emergency grade 1
timeFrame: 30-day
measure: Rate of emergency grade 2
timeFrame: 30-day
measure: Rate of salvage grade 1
timeFrame: 30-day
measure: Rate of salvage grade 2
timeFrame: 30-day
Locations:
city: Saint-Denis
country: France
facility: Francesco Nappi
Study officials:
affiliation: Cardiac Surgery Centre Cardiologique du Nord de Saint-Denis, Paris, France
name: Francesco Nappi, MD
role: STUDY_CHAIR
References:
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