Author + information
- 1Changhai Hospital, Shanghai, Shanghai, China
- 2Shanghai Changhai Hospital, Shanghai, Shanghai, China
- 3Ningbo Jenscare Biotechnology Co., Ltd, Ningbo, Zhejiang, China
- 4Ningbo Jenscare Biotechnology Co.,ltd, Ningbo, Zhejiang, China
- 5Ningbo Jenscare Biotechnology Co., Ltd, NIngbo, Zhejiang, China
- 6Shanghai Changhai Hosipital, Shanghai, Shanghai, China
Transcatheter aortic valve implantation (TAVI) has become an effective therapy for severe aortic stenosis in high-risk surgical candidates. The current challenge for TAVI in the treatment of aortic regurgitation is exact positioning and stable fixation of the valve in the aortic annulus. We evaluated a new bovine pericardial self-expandable TAVI device with a novel mechanism of leaflet-fixation (Ken-Valve, Jenscare Ltd, China) by a long-term animal experiment.
The Ken-valves were implanted transapically in 20 healthy adult goats under fluoroscopic guidance through a 28F sheath via a specially designed delivery catheter. The deployment was performed on the beating heart without cardiopulmonary bypass or rapid ventricular pacing. Serial TTE and aortic root angiography were performed immediately after each operation and also during their recovery stage (6months). Aortic root specimens were collected for pathologic examination and calcification evaluation in leaflets.
The Ken-Valves were successfully implanted and positioned accurately. Eighteen animals survived until they were sacrificed. TEE showed that the Ken-valves worked well with no stenosis or regurgitation in all animals, except for paravalvular leakage in 5 (4 mild and 1 mild-to-moderate). The mean transvalvular gradient at 3 months and 6 months were 3.2 ± 0.6mmHg and 2.4 ± 0.8mmHg, respectively, with no significant difference from that immediately after operation (2.3±0.4mmHg). Autopsy showed no stent fracture, stent displacement or coronary obstruction at 6 months. Histological examination showed well preserved leaflet collagen fiber structures. The calcium content of the pericardial leaflets was 37.7 ± 12.8ug / g at 6 months after operation, with no significant difference from that before implantation (30.8 ± 7.6ug / g).
The Ken-valve provides an effective concept of fixation with a special clamping and anchoring mechanism that allows exact positioning and anchoring the valve to the native leaflets. The design of leakproof ring can effectively avoid the occurrence of paravalvular leakage. This bioprosthetic valve has a good safety and durability, and further investigations by clinical trial are necessary.
STRUCTURAL: Valvular Disease: Aortic