Table 1.
Currently Available Animal Models and Methods of THV Evaluation
| Carney et al (2022)7 | Eltchaninoff et al (2006)5 | Scherman et al (2019)11 | PMA P130009: FDA Summary of Safety and Effectiveness Data (2012)4 | |
|---|---|---|---|---|
| Model | Sheep underwent the MAA procedure and were recovered. At 60 days post-MAA TAVI was performed. | Moderate to severe aortic insufficiency was created in 14 juvenile sheep using a bioptome device. A 23-mm PHV was implanted distal to the left subclavian artery. | None | Annuloplasty rings were surgically implanted into the aortic annulus to model the semirigid environment of the diseased aortic root found in the stenotic clinical situation. |
| Methods | TAVI 60 days after model creation. | TAVI in the heterotopic position following model creation. | A modified THV valve with anchoring mechanisms and stabilization arms implanted transapically. | THVs were surgically implanted, but deployed using a delivery system for simulated use. |
| Sheep | 5 p | 14 | 5 | 34 |
| Follow-up duration, d | 140 | 150 | 150 | 70 and 140 |
| Procedural success, % | 100 | 71 | 60 (2 significant paravalvular leaks) | 97 |
| Procedural mortality | 0 | 4 | 0 | 1 |
| 30-d mortality | 2 | 4 | 0 | NA |
| 70-d mortality | NA | NA | NA | 11 |
| 90-d mortality | NA | 2 | 0 | NA |
| 140-/150-d mortality | NA | 2 | 0 | 5 |
| Cumulative mortality at terminal follow-up | 2 (40) | 8 (57.1) | 0 | 17 (50) |
Values are n or n (%) unless otherwise indicated.
MAA = modified aortic annuloplasty; NA = not available; PHV = prosthetic heart valve; TAVI = transcatheter aortic valve implantation; THV = transcatheter heart valve.