The purpose of this study is to investigate the short to mid term efficacy and safety of different hybrid operations who had complex aortic lesions, such as ascending aortic/arch aneurysm, pseudo-aneurysm, Stanford Type A dissection, retrograde Stanford Type B dissection, dissection with primary tear located in the aortic arch, et al.
Aneurysms and dissection involving the ascending aorta and aortic arch have historically been treated with open surgical techniques, requiring cardiopulmonary bypass and deep hypothermic circulatory arrest (DHCA). Despite increasing experience and refinement of these procedures, there remains a substantial rate of morality and morbidity. The goal of hybrid operations is to re-construct the ascending aorta and aortic arch to cover the primary entry tear of the dissection and to remodel the aorta. Hybrid Operations including debranching technique+Thoracic Endovascular Aortic Repair (TEVAR), Frozen elephant trunk technique, aortic arch replacement with concommitant TEVAR, et al. The purpose of this study is to investigate the short to mid term efficacy and safety of different hybrid operations who had complex aortic lesions, such as ascending aortic/arch aneurysm, pseudo-aneurysm, Stanford Type A dissection, retrograde Stanford Type B dissection, dissection with primary tear located in the aortic arch, et al. Primary outcome measure is all-cause mortality. Secondary outcome variables include conversion to stent and/or surgery, induced thrombosis of the false lumen, cardiovascular morbidity, aortic expansion (\>5 mm/y of maximum diameter including true and false lumina), quality of life, and length of intensive care unit and hospital stay. The study designs to enroll 50 patients to be monitored for 24 months.
Study Type
OBSERVATIONAL
Enrollment
50
Hybrid Operations including debranching technique+Thoracic Endovascular Aortic Repair (TEVAR), Frozen elephant trunk technique, aortic arch replacement with concommitant TEVAR, et al. Devices include Medtronic Stent Graft(Medtronic Medtronic, Inc., US) Microport Stent Graft(Microport Co.,LTD.,Shanghai, China) Ankura Stent Graft(Lifetech Scientific Co.,LTD.,Shenzhen, China).
Department of Cardiovascular Surgery of Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, China
RECRUITINGCumulative MACE
Cumulative MACE (including death, rupture, paraplegia, aneurysm formation et al)
Time frame: 12 months
Endoleak
Endoleak of all types from the stent graft
Time frame: 12 months
Stent-graft migration/kinking
Stent-graft migration, stenosis, kinking and other conditions requiring re-intervention
Time frame: 12 months
Cumulative cerebrovascular events
Cumulative cerebrovascular events as bleeding, thrombosis, paraplegia, transient unconsciousness, et al.
Time frame: 12 months
Liver/Kidney dysfunction
Liver dysfunction including jaundice,transaminase elevation 1.5 times more than normal, et al. Kidney dysfunction including oliguria, anuria, Creatinine/BUN elevation 1.5 times more than normal, et al.
Time frame: 12 months
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