Evaluation of the safety and efficacy of a novel Anatomical classification and dUal anchoRing theory to Optimize the tavR strategy for pure severe Aortic regurgitation (AURORA): a prospective cohort study.

BACKGROUND: Success rate of transcatheter aortic valve replacement (TAVR) in aortic regurgitation (AR) patients is relatively low on account of the absence of calcified anchoring structures. Morphological classification and corresponding TAVR strategies for AR are lacking yet. METHODS: The AURORA study is a prospective, multicenter, single-arm cohort study to evaluate the safety and efficacy of transfemoral TAVR for severe AR in patients with high or prohibitive risk for surgery. Patients who are ≥ 65 years and diagnosed with severe pure AR as defined by the Echocardiographic Core Laboratory will be consecutively enrolled for further multidetector computed tomography (MDCT) scanning and multiplanar analyses. Based on a new anatomical classification and dual anchoring theory, patients will be classified into 4 types according to the level of the anchoring area. Types 1, 2 and 3 (at least 2 anchoring areas) will undergo the TAVR procedure with a domestic Chinese self-expanding valve (VitaFlow Valve, MicroPort, Shanghai, China), whereas type 4 (0 or 1 anchoring area) patients will be considered unsuitable for TAVR and will receive medical treatment. Our goal is to recruit 100 patients to account for 10% missing data or loss of patients to follow-up. Procedural, 30-day, 6-month and 12-month outcomes will be assessed according to Valve Academic Research Consortium-3 criteria. DISCUSSION: The AURORA study will establish a new AR anatomical classification based on dual anchoring theory through MDCT multiplanar measurement and assess the safety and efficacy of TAVR guided by this new classification and strategy in AR patients. TRIAL REGISTRATION: This Study was registered at Chinses Clinical Trial Registry. The registration number: ChiCTR2200055415; The date of registration: 9, January 2022; The URL of the registration: http://www.chictr.org.cn/showproj.aspx?proj=141209 .

[Endovascular stent-graft repair for penetrating atherosclerotic ulcer of the descending aorta].

OBJECTIVE: To summarize the clinical experience and effectiveness of endovascular stent-graft placement for the treatment of penetrating atherosclerotic ulcer of the descending thoracic aorta. METHODS: From August 2002 to February 2006, 14 patients with penetrating atherosclerotic ulcer accepted endovascular stent-grafts placement. All patients were men, their average age was 60 years. The clinical symptoms included thoracalgia or notalgia or celiodynia (n = 13) and hemoptysis (n = 3). 11 patients had hypertension. All patients were diagnosed by CT or MRI scans. Via the cutdown on a femoral artery at local anesthesia, the stent-graft was placed after completion angiography. Then DSA examine was repeated. X-ray and EBCT or MDCT scans were performed at follow-up. RESULTS: 16 Stent-grafts were successfully placed in 14 patients, in which 2 cases were placed with two stent-grafts respectively. There were Talent stent-grafts (n = 11) and Aegis stent-grafts (n = 5). The diameter of endovascular stent-graft ranged 32 mm to 38 mm exceeding by 10% - 20% of aortic diameter of anchoring zone. Instant angiography revealed no endoleak in 12 patients, minor endoleak in 2 patients. Within the follow-up average 17.2 months, CT scans demonstrated the disappearances of penetrating atherosclerotic ulcer or exclusion of aortic pseudoaneurysm in all patients, and absorption of intramural hematoma in two patients. One patient died of rupture of aortic pseudoaneurysm after one month. CONCLUSION: Penetrating atherosclerotic ulcer can leads to intramural hematoma, dissection, aneurysmal dilatation, pseudoaneurysm, or aortic rupture. Therefore it should be treated once diagnosed. Endovascular stent-graft placement may be an effective treatment for penetrating atherosclerotic ulcer, especially in patients with poor condition.