Triple-branch Stent Graft Placement for the Treatment of Acute DeBakey I Aortic Dissection
Condition: Acute Aortic Dissection
MeSH terms: Aortic Dissection
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate triple-branched stent placement in the treatment of
      acute DeBakey I aortic dissection . The investigators design a prospective, single-center,
      open-label, non-controlled clinical trial.
    

Detailed description: 
      From November 2015, 150 consecutive patients with acute DeBakey I aortic dissection were
      treated with triple-branched stent placement.

      In all cases, surgery was performed under general anesthesia with tracheal intubation and
      cardiopulmonary bypass (CPB). During surgery arterial pressures at the upper and lower limbs
      were monitored. An esophageal echocardiography probe was placed routinely, and a sternal
      incision was performed. To establish CPB, the perfusion tube was placed in the right axillary
      artery and the drainage tube was placed in the superior and inferior vena cava through the
      right atrium. The CPB flow rate was of 2.4-2.6 L/kg/min. Intermittent cold blood cardioplegia
      was perfused through the left and right coronary arteries for myocardial protection.

      The innominate artery and the left common carotid artery were fully isolated during the CPB
      cooling process. The ascending aorta proximal to the innominate artery was occluded, and the
      ascending aorta was transected slightly above the sinus tube connection; the left and right
      coronary arteries were directly perfused with blood-containing cold cardioplegia. Proximal
      procedures such as aortic valve repair, sinus reconstruction, and root replacement were
      performed first. Afterwards, the stumps were reconstructed. The reconstructed aortic root
      stump was anastomosed with a Dacron graft of corresponding size using 4-0 polypropylene
      suture (ascending aorta replacement). The nasopharyngeal temperature was then decreased to
      25° (usually a rectal temperature of 27-29°C), the aortic perfusion flow was set to 10-15
      ml/kg/min, and the innominate artery and the left common carotid artery were occluded 5-6 cm
      above the aortic arch. The aortic occlusion clamp was removed and a half aortic arch
      transection was made about 2 cm proximal to the innominate artery. Through the incision, the
      true lumens of the aortic arch, the proximal descending aorta, and the three aortic branches
      were identified. The triple-branched stent graft was inserted into the true lumens of the
      aortic arch and proximal descending aorta; the three stent graft branches were then placed
      into the corresponding true lumens of the aortic arch branch vessels followed by the
      sequential release of the vascular stent backbone and the branch stents in the left
      subclavian artery, the left common carotid artery, and the innominate artery. A catheter with
      a balloon or a probe was used to expand the vascular stents and the graft and branches were
      examined for kinks or folding of the backbone. A sandwich reconstruction was performed
      between the aortic stump, the aortic external Dacron graft, and the proximal stentless suture
      zone of the intraluminal artificial vessel backbone. The reconstructed stump was anastomosed
      with the Dacron graft that replaced the ascending aorta using 4-0 polypropylene suture. The
      occlusions of the left common carotid artery and the innominate artery were then relieved,
      and air was fully flushed out from the heart and the aorta. The right axillary artery
      perfusion was stopped, and systemic perfusion via an aortic perfusion tube at the artificial
      portion of the ascending aorta was performed. The patient was rewarmed after oxygen debt
      repayment, followed by the cardiac resuscitation.

      Telephone contact was maintained with the patients after discharge. At 3,6,12 months
      postoperatively , patients received a follow-up examination, chest radiography,
      echocardiography, bilateral carotid artery Doppler examinations and CT angiography (CTA)
      examinations Numerical data were expressed as percentages. Quantitative data were expressed
      as mean ± standard deviation. The primary end point is the occluded rate of the false lumen
      one year postoperatively. The secondary end point are the survive rate ,complication,
      reoperation rate, the growth rate of thoracic descending aorta, security index
      perioperatively, life quality postoperatively.Statistical analysis were performed with SPSS
      11.5 software. A value of P < 0.05 was considered statistically significant.
    

Intervention name(s): triple-branched stent graft
Intervention type(s): Procedure
Intervention description(s): place the triple-branched stent graft into the aortic arch, descending aorta ,the left subclavian artery, the left common carotid artery, and the innominate artery.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: triple-branched stent graft; the occluded rate of false lumen