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.
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
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
Parallel
Conventional hemiarch replacement
Procedure/SurgeryConventional open hemiarch replacement
E-vita® Open Neo; Artivion
Procedure/SurgeryE-vita® Open Neo is a hybrid stent graft system for aortic arch and descending thoracic aorta repair with Frozen Elephant Trunk Technique.
Thoraflex Hybrid; Terumo
Procedure/SurgeryThe 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.
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.
Malperfusion with respect to radiological evidence
True lumen cross sectional area divided by total aortic cross sectional area at the narrowest part in descending thoracic aorta. Significant radiological ischemia definited as \<20% (True Lumen/Total aortic cross sectional area)
Malperfusion with respect to biochemical evidence
High lactate: Lactate \> 4
Malperfusion with respect to biochemical evidence
Acidosis: pH \< 7.35
Malperfusion with respect to biochemical evidence
Dearranged LFT: any increase in ALP, ALT, Bilirubin 5% more than baseline
Percentage of patients with Major Adverse Events
Rate of patients who are free from the following Major Adverse Events (MAEs) (new permanent disabling stroke), new permanent (\> 30 days) paraplegia or paraparesis, reintervention (excluding reoperation for bleeding or planned or unplanned additional intervention), visceral mal-perfusion, limb(s) ischemia
Percentage of patients requiring additional aortic intervention
Rate of patients with aortic rupture and additional intervention (planned / unplanned)
Percentage of patients with Renal failure
Renal failure requiring permanent (\> 90 days) dialysis or hemofiltration in a patient with a normal pre-procedure serum creatinine level
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Chinese University of Hong Kong
Lead sponsor
University of Vienna
Collaborator
Mahidol University
Collaborator
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