Randomized Control Trial of Total Arch Replacement With Frozen Elephant Trunk Versus Conventional Hemiarch Replacement in Patients With Acute Type A Aortic Dissection (TARFET-TAAD)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 3
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
Project Objectives:
- The primary objective is 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.
- The secondary objective is to evaluate the impact of TARFET and HAR in patients with ATAAD complicated with mal-perfusion syndrome.
- The third objectives include comparing the rates of major adverse cardiovascular and cerebrovascular events (MACCE), renal replacement therapy, aortic reintervention, and other relevant clinical outcomes within 30 days.
Background 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. (IRAD and GERAAD). For the same reason, high quality clinical studies are lacking, and the current guideline are largely based on non-randomized clinical trials and prospective studies (EACTS/STS/AHA guideline). Data from international registries showed the mortality of surgically treated ATAAD was around 17-26% and those with mal-perfusion had even higher mortality. The primary goals of surgical therapy in ATAAD are to replace the ascending thoracic aorta together with the primary entry tear, sealing of the false lumen (FL) and the distal anastomotic site and decompression the false lumen and resolve distal mal-perfusion. 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 (DANE) 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 a more complex and 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 where entry tear is beyond ascending aorta. The investigators aim to conduct a multi-centers, randomized control trial to compare the 30-day mortality of patients with ATAAD who undergo HAR versus TARFET.
Main research questions
- To evaluate the all-cause 30-day mortality rate between the TARFET and HAR groups in patients with ATAAD where entry tear is beyond the ascending aorta.
- To evaluate the impact of TARFET and HAR in patients with ATAAD complicated with mal-perfusion syndrome.
- To compare the rates of major adverse cardiovascular and cerebrovascular events (MACCE), renal replacement therapy, aortic reintervention, and other relevant clinical outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Conventional Hemiarch group (HAR)
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
干预措施: Conventional hemiarch replacement (Procedure)
Total Arch Replacement and Frozen Elephant Trunk group (TARFET)
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.
干预措施: E-vita® Open Neo; Artivion (Procedure)
Total Arch Replacement and Frozen Elephant Trunk group (TARFET)
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.
干预措施: Thoraflex Hybrid; Terumo (Procedure)
结局指标
主要结局
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.
时间窗: From enrollment to the end of treatment at 30 days
次要结局
- 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 clinical evidence(From enrollment to 12 months after treatment.)
研究者
Randolph Wong
Professor and Chief of Division of Cardiothoracic Surgery, Department of Surgery
Chinese University of Hong Kong