Making all the right moves with TAVR
Every move in chess is crucial, especially the first move. Similarly, it’s crucial to choose the right TAVR platform for the index procedure to ensure successful lifetime management for your patients.
Successful lifetime management with TAVR depends on:
- Consistent clinical outcomes starting with the index procedure
- Robust valve durability that enhances long-term outcomes
- Design that allows for future interventions
Experts recommend that any TAVR platform should offer successful lifetime management. Outcomes should be reliable despite patient anatomy, location, and valve size. The design should target non-structural and structural drivers of reintervention, such as mitigating calcification, a leading cause to valve failure. Lastly, TAVR platforms need to provide coronary access and options for re-do procedures.
What valve is your first choice for TAVR and why?
Nov. 29,2023
The valve of first choice is usually the Edwards SAPIEN 3 valve. The investigators in the PARTNER 3 Trial (New England Journal of Medicine, May 2, 2019) concluded that among patients with severe aortic stenosis who were at low surgical risk, the rate of the composite of death, stroke, or re-hospitalization at 1 year was significantly lower with TAVR (utilizing an Edwards SAPIEN 3 valve) than with surgery. Patients will also regain their independence quicker.
A systemic review demonstrated coronary obstruction is more common after TAVI with a balloon- expandable valve then a self-expanding valve, a finding corroborated by a subsequent multicenter registry. The inability to reposition or retrieve makes the Sapien family of balloon expandable valves an unattractive choice in patients at high risk of coronary obstruction.
While I really like the advances in Evolut FX platform, I would say my first choice for TAVR would be the 5th generation Sapien X4 THV platform which has been redesigned for lifetime management of AS. Some of the improvements are 1) Enhanced anticalcification technology with the RESILIA tissue platform, 2) 3 available THV sizes (23, 26, and 29 mm, with 16 unique deployment diameters in increments), 3) Enhanced polyethylene (PET) outer skirt designed to minimize PVL while maintaining low profile access. 4) All this improvement is still going to be available in a 14/16F expandable sheath.
This concept is being tested in the ALLIANCE study (ongoing) assessing the safety/efficacy of the new SAPIEN X4 in a broad patient population, including any surgical risk level, bicuspid anatomy, and valve-in-valve patients.