Post-TAVI Coronary Access Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- PCI device success
研究概览
简要总结
Coronary access after trans-catheter aortic valve implantation (TAVI) remains a major challenge. With the evolution of TAVI procedure and the inclusion of lower-risk patients with aortic stenosis, future coronary access is an even greater concern, because this lower-risk patient group has a greater cumulative risk of requiring coronary angiography for acute coronary events compared to their octogenarian counterparts.
It is only speculated that the intra-annular position of the self-expandable valves together with the frame covering coronary ostia would impose a significant technical challenge as compared to the balloon-expandable valve (1). However, this remains to be proven. With any valve used, increased catheter manipulations may result in longer fluoroscopy times, larger volumes of contrast, and reduced imaging quality due to non-selective injections (2).
Although complex, coronary procedures after TAVR are considered relatively safe and feasible on experience hands (3-6). A number of techniques to increase the likelihood of successful coronary intubation after TAVR have been described in the published reports and include the use of intracoronary guidewires (1), as well as balloon-assisted tracking with guideliner extension (7). It is therefore essential to fully understand the potential challenges of coronary angiography and PCI in this specific patient population. Guidance by a specific algorithm may help to overcome difficulties in coronary angiography and facilitate selective coronary intubation particularly during primary PCI (8).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 100 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prior TAVI for aortic stenosis or regurgitation in bicuspid or tricuspid valve
- •Clinical indication for PCI
排除标准
- •Prior TAVI valve-in-valve procedures
- •Prior TAVI-in-TAVI procedures
结局指标
主要结局
PCI device success
时间窗: 5 year
次要结局
- Final TIMI flow(5 year)
- Incidence of procedural complications(5 year)
- Successful withdrawal of the device delivery system(5 year)
- Attainment of a final in-stent or in-scaffold residual stenosis of <20%(5 year)
- Successful delivery, balloon expansion, and deployment of the first assigned device, at the intended target lesion(5 year)
- Successful selective engagement of guiding catheter(5 year)
- Procedural mortality(5 year)
研究者
Dr. Issi Barbash
Prof
Sheba Medical Center
