NCT04649190

Post-TAVI Coronary Access Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 200 (actual)
• Sponsor: Sheba Medical Center · Other Government
• Sex: All
• Age: 100 Years
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Transcatheter Aortic Valve Replacement

Interventions

Type	Name	Description
DEVICE	TAVI	Coronary access for PCI after TAVI

Timeline

• Start date: 2010-01-01
• Primary completion: 2023-01-01
• Completion: 2023-06-01
• First posted: 2020-12-02
• Last updated: 2023-06-13

Locations

1 site across 1 country: Israel