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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| triple-branched stent graft | Experimental | The triple-branched stent graft was a branched 1-piece graft and included a main stent graft and 3 sidearm stent grafts (Yuhengjia Science and Technology, Corp, Ltd, Beijing, China). The main stent graft and sidearm stent grafts were individually mounted on 4 catheters and restrained by 4 silk sutures .The triple-branched stent graft was inserted into the true lumens of the aortic arch and proximal descending aorta; the three vascular stent branches were then grafted 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| triple-branched stent graft | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| the occluded rate of false lumen by CTA | one year postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| the survive rate by the questionaire | 3 months, 6 months, 12 months postoperatively | |
| complication by the case report | 1 months postoperatively | |
| reoperation rate by the case report |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Department of Cardiovascular Surgery | Fuzhou | Fujian | 350001 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11603441 | Background | Estrera AL, Miller CC 3rd, Huynh TT, Porat E, Safi HJ. Neurologic outcome after thoracic and thoracoabdominal aortic aneurysm repair. Ann Thorac Surg. 2001 Oct;72(4):1225-30; discussion 1230-1. doi: 10.1016/s0003-4975(01)02971-x. | |
| 15618075 | Background | Chiappini B, Schepens M, Tan E, Dell' Amore A, Morshuis W, Dossche K, Bergonzini M, Camurri N, Reggiani LB, Marinelli G, Di Bartolomeo R. Early and late outcomes of acute type A aortic dissection: analysis of risk factors in 487 consecutive patients. Eur Heart J. 2005 Jan;26(2):180-6. doi: 10.1093/eurheartj/ehi024. Epub 2004 Dec 7. |
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| 1 year postoperatively |
| the growth rate of thoracic descending aorta by CTA | 3 months, 6 months, 12 months postoperatively |
| life quality by the questionaire | 3 months, 6 months, 12 months postoperatively |
| 15632832 | Background | Trimarchi S, Nienaber CA, Rampoldi V, Myrmel T, Suzuki T, Mehta RH, Bossone E, Cooper JV, Smith DE, Menicanti L, Frigiola A, Oh JK, Deeb MG, Isselbacher EM, Eagle KA; International Registry of Acute Aortic Dissection Investigators. Contemporary results of surgery in acute type A aortic dissection: The International Registry of Acute Aortic Dissection experience. J Thorac Cardiovasc Surg. 2005 Jan;129(1):112-22. doi: 10.1016/j.jtcvs.2004.09.005. |
| 17184630 | Background | Rampoldi V, Trimarchi S, Eagle KA, Nienaber CA, Oh JK, Bossone E, Myrmel T, Sangiorgi GM, De Vincentiis C, Cooper JV, Fang J, Smith D, Tsai T, Raghupathy A, Fattori R, Sechtem U, Deeb MG, Sundt TM 3rd, Isselbacher EM; International Registry of Acute Aortic Dissection (IRAD) Investigators. Simple risk models to predict surgical mortality in acute type A aortic dissection: the International Registry of Acute Aortic Dissection score. Ann Thorac Surg. 2007 Jan;83(1):55-61. doi: 10.1016/j.athoracsur.2006.08.007. |
| 1614214 | Background | Crawford ES, Kirklin JW, Naftel DC, Svensson LG, Coselli JS, Safi HJ. Surgery for acute dissection of ascending aorta. Should the arch be included? J Thorac Cardiovasc Surg. 1992 Jul;104(1):46-59. |
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| 12607666 | Background | Urbanski PP, Siebel A, Zacher M, Hacker RW. Is extended aortic replacement in acute type A dissection justifiable? Ann Thorac Surg. 2003 Feb;75(2):525-9. doi: 10.1016/s0003-4975(02)04378-3. |
| 12114376 | Background | Khan IA, Nair CK. Clinical, diagnostic, and management perspectives of aortic dissection. Chest. 2002 Jul;122(1):311-28. doi: 10.1378/chest.122.1.311. |
| 19632398 | Background | Pochettino A, Brinkman WT, Moeller P, Szeto WY, Moser W, Cornelius K, Bowen FW, Woo YJ, Bavaria JE. Antegrade thoracic stent grafting during repair of acute DeBakey I dissection prevents development of thoracoabdominal aortic aneurysms. Ann Thorac Surg. 2009 Aug;88(2):482-9; discussion 489-90. doi: 10.1016/j.athoracsur.2009.04.046. |
| 21315615 | Background | Kim JB, Chung CH, Moon DH, Ha GJ, Lee TY, Jung SH, Choo SJ, Lee JW. Total arch repair versus hemiarch repair in the management of acute DeBakey type I aortic dissection. Eur J Cardiothorac Surg. 2011 Oct;40(4):881-7. doi: 10.1016/j.ejcts.2010.12.035. Epub 2011 Feb 18. |
| 17643619 | Background | Zierer A, Voeller RK, Hill KE, Kouchoukos NT, Damiano RJ Jr, Moon MR. Aortic enlargement and late reoperation after repair of acute type A aortic dissection. Ann Thorac Surg. 2007 Aug;84(2):479-86; discussion 486-7. doi: 10.1016/j.athoracsur.2007.03.084. |
| 17198797 | Background | Halstead JC, Meier M, Etz C, Spielvogel D, Bodian C, Wurm M, Shahani R, Griepp RB. The fate of the distal aorta after repair of acute type A aortic dissection. J Thorac Cardiovasc Surg. 2007 Jan;133(1):127-35. doi: 10.1016/j.jtcvs.2006.07.043. Epub 2006 Dec 4. |
| 19101279 | Background | Park KH, Lim C, Choi JH, Chung E, Choi SI, Chun EJ, Sung K. Midterm change of descending aortic false lumen after repair of acute type I dissection. Ann Thorac Surg. 2009 Jan;87(1):103-8. doi: 10.1016/j.athoracsur.2008.09.032. |
| 18573404 | Background | Jakob H, Tsagakis K, Tossios P, Massoudy P, Thielmann M, Buck T, Eggebrecht H, Kamler M. Combining classic surgery with descending stent grafting for acute DeBakey type I dissection. Ann Thorac Surg. 2008 Jul;86(1):95-101. doi: 10.1016/j.athoracsur.2008.03.037. |
| 19231387 | Background | Uchida N, Shibamura H, Katayama A, Shimada N, Sutoh M, Ishihara H. Operative strategy for acute type a aortic dissection: ascending aortic or hemiarch versus total arch replacement with frozen elephant trunk. Ann Thorac Surg. 2009 Mar;87(3):773-7. doi: 10.1016/j.athoracsur.2008.11.061. |
| 20172130 | Background | Gorlitzer M, Weiss G, Meinhart J, Waldenberger F, Thalmann M, Folkmann S, Moidl R, Grabenwoeger M. Fate of the false lumen after combined surgical and endovascular repair treating Stanford type A aortic dissections. Ann Thorac Surg. 2010 Mar;89(3):794-9. doi: 10.1016/j.athoracsur.2009.11.054. |
| 20855660 | Result | Chen LW, Dai XF, Lu L, Zhang GC, Cao H. Extensive primary repair of the thoracic aorta in acute type a aortic dissection by means of ascending aorta replacement combined with open placement of triple-branched stent graft: early results. Circulation. 2010 Oct 5;122(14):1373-8. doi: 10.1161/CIRCULATIONAHA.110.946012. Epub 2010 Sep 20. |
| 21576657 | Result | Chen LW, Wu XJ, Lu L, Zhang GC, Yang GF, Yang ZW, Dong Y, Cao H, Chen Q. Total arch repair for acute type A aortic dissection with 2 modified techniques: open single-branched stent graft placement and reinforcement of the dissected arch vessel stump with stent graft. Circulation. 2011 Jun 7;123(22):2536-41. doi: 10.1161/CIRCULATIONAHA.110.008656. Epub 2011 May 16. |