Clinical trial NCT05912634: Repair Versus Non-repair of the Aortic Arch in Type A Aortic Dissection
Official title: Early Complication and Outcomes in Surgical vs no Surgical Involvement of Aortic Arch in Type A Aortic Dissection
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Aortic Dissection
Aortic Arch
Aortic Dissection Rupture
Aortic Dilatation
Keywords: Type A Aortic Dissection (TAAAD)
Root-Sparing Replacement
Ascending Aorta Replacement
Partial Arch Repair
Total Arch Replacement (TARP)
Frozen Elephant Trunk (FET)
Hemiarch Procedures
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
First posted: 2023-06-22
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The retrospective multicenter study including patients who underwent surgery for acute TAAAD at 5 centers of cardiac surgery located in 2 European countries and Japan (2 France, 2 Italy and 1 Hokkaido ). Data will be prospectively collected fron patients (conservative vs estensive TAAD- R) treated during the study period and 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. Data on consecutive patients with acute TAAD will be collected with pre-specified baseline, operative and outcome variables.

Brief summary: 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

Detailed description: 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.

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 acute heart failure
timeFrame: 30-day
measure: Stroke
timeFrame: 30-day
measure: Rate of global brain ischemia
timeFrame: 30-days
measure: Rate of mesenteric ischemia
timeFrame: 30-days
measure: Rate of acute kidney injury
timeFrame: 30-days
Secondary outcomes:
measure: Rate of paraplegia/paraparesis
timeFrame: 30-day
measure: Rate of perioperative bleeding
timeFrame: 30-day
measure: Rate of reoperation for bleeding
timeFrame: 30-day
measure: Rate of mechanical circulatory support
timeFrame: 30-day
measure: Late outcomes
timeFrame: 18 years
Other outcomes:
measure: Rate of urgent procedure
timeFrame: 30-days
measure: Rate of emergency grade 1
timeFrame: 30-days
measure: Rate of emergency grade 2
timeFrame: 30-days
measure: Rate of salvage grade 1
timeFrame: 30-days
measure: Rate of salvage grade 2
timeFrame: 30-days
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
role: STUDY_CHAIR
References:
citation: Geirsson A, Shioda K, Olsson C, Ahlsson A, Gunn J, Hansson EC, Hjortdal V, Jeppsson A, Mennander A, Wickbom A, Zindovic I, Gudbjartsson T. Differential outcomes of open and clamp-on distal anastomosis techniques in acute type A aortic dissection. J Thorac Cardiovasc Surg. 2019 May;157(5):1750-1758. doi: 10.1016/j.jtcvs.2018.09.020. Epub 2018 Sep 29.
citation: Harris KM, Nienaber CA, Peterson MD, Woznicki EM, Braverman AC, Trimarchi S, Myrmel T, Pyeritz R, Hutchison S, Strauss C, Ehrlich MP, Gleason TG, Korach A, Montgomery DG, Isselbacher EM, Eagle KA. Early Mortality in Type A Acute Aortic Dissection: Insights From the International Registry of Acute Aortic Dissection. JAMA Cardiol. 2022 Oct 1;7(10):1009-1015. doi: 10.1001/jamacardio.2022.2718.
citation: Benedetto U, Dimagli A, Kaura A, Sinha S, Mariscalco G, Krasopoulos G, Moorjani N, Field M, Uday T, Kendal S, Cooper G, Uppal R, Bilal H, Mascaro J, Goodwin A, Angelini G, Tsang G, Akowuah E. Determinants of outcomes following surgery for type A acute aortic dissection: the UK National Adult Cardiac Surgical Audit. Eur Heart J. 2021 Dec 28;43(1):44-52. doi: 10.1093/eurheartj/ehab586.
citation: O'Hara D, McLarty A, Sun E, Itagaki S, Tannous H, Chu D, Egorova N, Chikwe J. Type-A Aortic Dissection and Cerebral Perfusion: The Society of Thoracic Surgeons Database Analysis. Ann Thorac Surg. 2020 Nov;110(5):1461-1467. doi: 10.1016/j.athoracsur.2020.04.144. Epub 2020 Jun 26.
citation: Czerny M, Schoenhoff F, Etz C, Englberger L, Khaladj N, Zierer A, Weigang E, Hoffmann I, Blettner M, Carrel TP. The Impact of Pre-Operative Malperfusion on Outcome in Acute Type A Aortic Dissection: Results From the GERAADA Registry. J Am Coll Cardiol. 2015 Jun 23;65(24):2628-2635. doi: 10.1016/j.jacc.2015.04.030.