Valvular & structural heart disease
Optimized Balloon-Expandable Transcatheter Aortic Valve Implantation and Clinical Outcomes
Main finding · Modified early safety endpointResult — go to the resultAdjusted odds ratio 3.05 95% CI 2.30–4.04Authors' conclusion
Optimal THV implantation was associated with improved early procedural safety and long-term THV durability in balloon-expandable TAVR. Systematic fluoroscopic assessment of optimized valve implantation may enhance patient outcomes.
Study context
- Population
- Patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) with balloon-expandable prostheses (Sapien S3, Sapien S3 Ultra) between February 2014 and June 2022mean age 81 ± 6 years, 35.1% female
- Participants
- 1,032 patients
- Exposure
- Suboptimal vs optimal transcatheter heart valve (THV) implantation
- Suboptimal implantationn = 443
Methodological detailsconsecutive patients
- Consecutive patients
Main finding
Modified early safety endpoint · 30 days
Adjusted odds ratio
3.05
95% CI 2.30–4.04
By group
Suboptimal implantation vs Optimal implantation
adjusted odds ratio 3.05 (95% CI 2.30–4.04)
As reported in the abstract
Observational data: associations, not effects.
Further findings
| Outcome | subHR (95% CI) | |
|---|---|---|
| Stage 2 bioprosthetic valve failure · 5 years | 4.40 (1.25–13.59) | |
| Hemodynamic valve deterioration, patients with ≥2 determinants · 5 years · higher rates with ≥2 determinants; comparator not stated | 3.48 (1.24–9.80) | |
| 0.050.21520Subdistribution hazard ratio (log scale) |
Determinants of suboptimal implantation
- Suboptimal THV implantation
- 443 (42.9%)
- Noncoaxial deployment
- n = 240, 23.3%
- Excessive implantation depth
- n = 261, 25.3%
- Underexpansion
- n = 54, 5.2%
Original publication
Optimized Balloon-Expandable Transcatheter Aortic Valve Implantation and Clinical Outcomes. JACC Adv. doi:10.
Summarised from the published abstract; every number is checked against it