Total Arch Replacement With Frozen Elephant Trunk Versus Hemiarch Replacement in the Management of Acute Type A Aortic Dissection

NCT06676371 | Not Yet Recruiting DMC

• 1 other identifier: CRER Ref No.: NTEC-2024-574
• Study Type: interventional
• Target: 150
• Locations: 3 countries
• Sites: 3

Brief Summary

Acute Type A aortic dissection (ATAAD) and its complications are life-threatening conditions that cause more than 1400 hospital admissions and 300 deaths every year in Hong Kong and cause 172,927 deaths globally in 2019. There is an increasing trend in recent years. Given the hyperacute presentation and complexity of the clinical manifestation with various mal-perfusion syndromes, the mortality of ATAAD remained high in all international reported registries and published series. Conventional Hemiarch (HAR) replacement has been the gold standard procedure for ATAAD in most of cardiac surgical centers around the world because of the relative simplicity of the procedure. However, around 50-70% of patients were reported to develop distal anastomosis new entry after hemiarch procedure and for those with entry tear over aortic arch and distal mal-perfusion, hemiarch alone might not be able to solve the downstream problem. On the other hand, total arch replacement and frozen elephant trunk procedure (TARFET) is more complex, technically demanding procedure that could potentially cover/resect the arch entry tear and exclude tear over proximal descending thoracic aorta and, hence, solve the distal mal-perfusion syndrome. To date, there is no randomized control trial to answer whether HAR or TARFET procedure is superior in patients with ATAAD and entry tear is over the aortic arch or proximal descending thoracic aorta. We plan to conduct a multi-center trial to recruit consecutive patients with ATAAD with entry tear beyond ascending aorta and randomized them, after informed consent, into either the conventional hemiarch replacement group (HAR) or total arch replacement and frozen elephant trunk (TARFET). The participating centers will collect pre- operative, intra-operative and post-operative clinical parameters for two groups of patients via REDCap system. Written informed consent, specifically allowing the use of clinical records for this randomized study, will be obtained from every patient prior to data collection. The primary outcome is the 30-day mortality of the ATAAD patients with surgically treated by HAR versus TARFET approach. The secondary outcomes are the major adverse cardiovascular and cerebral events, post-op renal replacement therapy, re-exploration for bleeding and re-intervention within 30-days. This study will be the world's first multi-center randomized control trial in ATAAD to compare the 30-day mortality of patients treated with HAR and TARFET. It could be a guideline-changing study for the treatment of ATAAD and its impact on the surgical approach to patients suffering from ATAAD.

Conditions

Aortic Dissection Type A

Keywords

Total Arch Replacement and Frozen Elephant Trunk (TARFET); Conventional Hemiarch (HAR) replacement; Acute Type A aortic dissection (ATAAD)

Outcome Measures

Primary Outcomes (1)

• To evaluate the all-cause 30-day mortality rate between the TARFET and HAR groups in patients with acute type A aortic dissection with entry tear beyond ascending aorta.

  From enrollment to the end of treatment at 30 days

Secondary Outcomes (10)

• Malperfusion with respect to radiological evidence

  From enrollment to 12 months after treatment.

• Malperfusion with respect to biochemical evidence

  From enrollment to 12 months after treatment.

• Malperfusion with respect to biochemical evidence

  From enrollment to 12 months after treatment.

• Malperfusion with respect to biochemical evidence

  From enrollment to 12 months after treatment.

• Malperfusion with respect to biochemical evidence

  From enrollment to 12 months after treatment.

Other Outcomes (3)

• Percentage of patients with Major Adverse Events

  From enrollment to the end of treatment at 30 days

• Percentage of patients requiring additional aortic intervention

  From enrollment to the end of treatment at 30 days

• Percentage of patients with Renal failure

  From enrollment to the end of treatment at 30 days

Study Arms (2)

Conventional Hemiarch group (HAR)

ACTIVE COMPARATOR

Under general anesthesia and transesophageal echocardiogram monitoring, a median sternotomy will be performed. Patients will be placed on cardiopulmonary bypass using arterial inflow from the femoral artery, axillary artery, or direct aortic cannulation, along with right atrial appendage venous cannulation. Systemic cooling to 25 degrees Celsius will commence, followed by thiopental coma and circulatory arrest. The aorta will be trimmed to the distal ascending aorta or proximal arch, and antegrade cerebral perfusion will be initiated to the brachiocephalic branch. The distal anastomosis will connect a vascular graft to the distal ascending aorta or aortic arch. After completing this, systemic perfusion and rewarming will begin, followed by the proximal anastomosis with the vascular graft. After de-airing, the aorta will be de-clamped, and the patient will be weaned from cardiopulmonary bypass and decannulated. Hemostasis and sternal closure will follow standard institutional protocols

Procedure: Conventional hemiarch replacement

Total Arch Replacement and Frozen Elephant Trunk group (TARFET)

ACTIVE COMPARATOR

Under general anesthesia and transesophageal echocardiogram monitoring, a median sternotomy will be performed. Patients will be placed on cardiopulmonary bypass via femoral, axillary, or direct aortic cannulation. Systemic cooling to 25 degrees Celsius will lead to thiopental coma and circulatory arrest. The aorta will be trimmed to the distal arch, with antegrade cerebral perfusion initiated. Distal anastomosis will connect a vascular graft to the distal arch, followed by visceral perfusion, rewarming, and proximal anastomosis. After de-airing, the aorta will be de-clamped, and the patient will be weaned from bypass and decannulated. Hemostasis and sternal closure will follow standard protocols. Arterial cannulation sites for HAR and TARFET will be determined by the surgeon based on the clinical scenario.

Procedure: E-vita® Open Neo; Artivion; Procedure: Thoraflex Hybrid; Terumo

Interventions

Conventional hemiarch replacement PROCEDURE

Conventional open hemiarch replacement

Conventional Hemiarch group (HAR)

E-vita® Open Neo; Artivion PROCEDURE

E-vita® Open Neo is a hybrid stent graft system for aortic arch and descending thoracic aorta repair with Frozen Elephant Trunk Technique.

Total Arch Replacement and Frozen Elephant Trunk group (TARFET)

Thoraflex Hybrid; Terumo PROCEDURE

The Thoraflex Hybrid is a device system designed to repair a weakened and bulging section (aneurysm) and/or a tear in the lining (dissection) of the aorta behind the heart (aortic arch). The system includes a polyester graft section that reinforces a weakened section of the blood vessel, a connected stented section (nitinol wire frame on polyester graft material) that holds the artery open, and a delivery catheter that is used to place the device. The polyester graft and stented sections are coated with a protein substance taken from animal body parts (gelatin) to seal the implant and prevent blood from leaking out.

Total Arch Replacement and Frozen Elephant Trunk group (TARFET)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient 's age is between 18 and 80 years.
• Patient is willing and able to give informed consent.
• Patient has acute type A aortic dissection with entry tear beyond ascending aorta.
• Patient not in coma/irreversible end organ failure/cardiac massage for resuscitation

You may not qualify if:

• There is no identifiable entry tear in the aorta
• The ascending entry tear extends into aortic arch
• Patient has entry tear only in ascending aorta
• Patient with Type B aortic dissection
• Patient has co-morbidity (i.e. active malignancy (progressive, stable or partial remission)) causing expected survival to be less than 2 years.
• Patient has any other medical, social, or psychological problems, that in the opinion of the investigator, preclude the patient from participating in this study.

Sponsors & Collaborators

• Mahidol University: collaborator
• Chinese University of Hong Kong: lead
• University of Vienna: collaborator

Study Sites (3)

University Hospital Vienna

Vienna, Austria

Location

Prince of Wales Hospital

Hong Kong, Hong Kong

Location

Siriraj Hospital - Mahidol University

Bangkok, Thailand

Location

Related Publications (10)

• Lombardi JV, Hughes GC, Appoo JJ, Bavaria JE, Beck AW, Cambria RP, Charlton-Ouw K, Eslami MH, Kim KM, Leshnower BG, Maldonado T, Reece TB, Wang GJ. Society for Vascular Surgery (SVS) and Society of Thoracic Surgeons (STS) Reporting Standards for Type B Aortic Dissections. Ann Thorac Surg. 2020 Mar;109(3):959-981. doi: 10.1016/j.athoracsur.2019.10.005. Epub 2020 Jan 27.

  PMID: 32000979 BACKGROUND

• Ho JYK, Kim CH, Chow SCY, Kwok MWT, Lee H, Kim TH, Fujikawa T, Wong RHL, Song SW. Initial Asian experience of the branched E-vita open NEO in complex aortic pathologies. J Thorac Dis. 2023 Feb 28;15(2):484-493. doi: 10.21037/jtd-22-1055. Epub 2023 Feb 22.

  PMID: 36910067 BACKGROUND

• Fujikawa T, Kwok M, Ho J, Wong R. Open descending aortic replacement after Thoraflex hybrid graft implantation. Multimed Man Cardiothorac Surg. 2020 Jan 27;2020. doi: 10.1510/mmcts.2020.004.

  PMID: 32191402 BACKGROUND

• Tsagakis K, Kempfert J, Zierer A, Martens A, Dohle DS, Castiglioni A, Wong RH, Widenka K, Liakopoulos O, Borger MA, Oo AY, Holubec T, Luehr M, Legarra Calderon JJ, Grabenwoger M. E-vita OPEN NEO in the treatment of acute or chronic aortic pathologies: first interim results of the NEOS study. Eur J Cardiothorac Surg. 2024 Jun 3;65(6):ezae206. doi: 10.1093/ejcts/ezae206.

  PMID: 38830042 BACKGROUND

• Rylski B, Hahn N, Beyersdorf F, Kondov S, Wolkewitz M, Blanke P, Plonek T, Czerny M, Siepe M. Fate of the dissected aortic arch after ascending replacement in type A aortic dissectiondagger. Eur J Cardiothorac Surg. 2017 Jun 1;51(6):1127-1134. doi: 10.1093/ejcts/ezx062.

  PMID: 28369453 BACKGROUND

• 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.

  PMID: 26088302 BACKGROUND

• Hagan PG, Nienaber CA, Isselbacher EM, Bruckman D, Karavite DJ, Russman PL, Evangelista A, Fattori R, Suzuki T, Oh JK, Moore AG, Malouf JF, Pape LA, Gaca C, Sechtem U, Lenferink S, Deutsch HJ, Diedrichs H, Marcos y Robles J, Llovet A, Gilon D, Das SK, Armstrong WF, Deeb GM, Eagle KA. The International Registry of Acute Aortic Dissection (IRAD): new insights into an old disease. JAMA. 2000 Feb 16;283(7):897-903. doi: 10.1001/jama.283.7.897.

  PMID: 10685714 BACKGROUND

• Hospital Authority Statistical Report 2011-2012, Page 30, Table 1.2 www.ha.org.hk/upload/publication_15/471.pdf

  BACKGROUND

• Hospital Authority Statistical Report 2009-2010, Page 28, Table 1.1 www.ha.org.hk/upload/publication_15/321.pdf

  BACKGROUND

• Centre for Health Protection, Vital Statistics, Death Rates by Leading Causes of Death 1981-2000 www.chp.gov.hk/en/data/4/10/27/115.html

  BACKGROUND

Related Links

• Sample size calculator
• Total Aortic Arch Replacement

Central Study Contacts

Randolph Hung Leung Wong

CONTACT

+85235052622; wonhl1@surgery.cuhk.edu.hk

Eunice Man Ki Lo

CONTACT

+85235052629; eunicelo@surgery.cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Chief of Division of Cardiothoracic Surgery, Department of Surgery

Model Details: Randomized control trial of two groups

Study Record Dates

• First Submitted: October 28, 2024
• First Posted: November 6, 2024
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): October 1, 2029
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will become available when we complete our analysis and for a 12-month period
• Access Criteria: Approval needs to be sought from the Principal Investigator

Locations

AU (1); HK (1); TH (1)