Valvular & structural heart diseaseCohort study
30-Day and 1-Year Outcomes From the Optimize PRO Transcatheter Aortic Valve Replacement (TAVR) Evolut FX Addendum Study
- Prospective nonrandomised study
- postmarket
- multicentre
- single-group
- Median follow-up 371 days (Q1-Q3: 352-388 days)
Authors' conclusion
Implantation of the Evolut FX device with a refined COT was associated with low PPI rates and no severe AR at 1 year. Postprocedural CT demonstrated consistent commissural and coronary alignment.
Study context
- Population
- Patients with severe AS undergoing TAVR
- Participants
- 151 patients
- Outcome
- All-cause mortality or all stroke
- Follow-up
- 30 days and 1 year
Main finding
As reported in the abstract
All-cause mortality or all stroke at 30 days
2.7% (95% CI: 1.0%-6.9%)
All-cause mortality or all stroke at 1 year
7.5% (95% CI: 4.2%-13.1%)
Observational data: associations, not effects.
Further findings
Commissural alignment
- By marker positioning on fluoroscopy
- 91.5% (107 of 117)
- By computed tomography (CT)
- 86.9% (113 of 130)
- good agreement
Compliance with the refined cusp overlap technique (COT)
- Compliance with the refined COT
- 86.0%
Length of stay
- Median length of stay
- 1 day
Coronary alignment on CT
- No severe coronary misalignment
- >92%
Safety
New permanent pacemaker implantation (PPI)
- New PPI at 30 days
- 6.7% (95% CI: 3.7%-12.1%)
- New PPI at 1 year
- 8.8% (95% CI: 5.2%-14.6%)
Aortic regurgitation (AR) · 1 year
- Moderate AR
- 1
- Severe AR
- 0
Original publication
30-Day and 1-Year Outcomes From the Optimize PRO TAVR Evolut FX Addendum Study. JACC Cardiovasc Interv. Published 25 June 2025. doi:10.1016/j.jcin.2025.06.021
Summarised from the published abstract; every number is checked against it