Background
The JenaValve Trilogy (JV; JenaValve Technology GmbH) represents a first-in-class dedicated device for transcatheter aortic valve implantation (TAVI) for the treatment of pure non-calcific aortic regurgitation (AR). Using a dedicated anchoring mechanism, enabled by three locators that are placed in the nadirs of the three aortic cusps and "clip" the device onto the leaflets after release of the self-expanding frame, the system allows for secure placement, not needing leaflet calcification for proper anchoring.
Per design the device with its three locators ideally conforms to a standard tri-leaflet anatomy. Whether such system could also be safely and effectively used in a bicuspid anatomy remains to be tested.
Patient History
Here, we report the case of a 80-years old male patient with a history of partial lung resection and cardiac history of persistent atrial fibrillation and calcific coronary disease. The patient presented to the clinic with persistent dyspnea on exertion (NYHA III). Echocardiography revealed severe aortic regurgitation (VC 7.3mm, holodoastolic flow reversal in AoDesc, jet 75% of LVOT diameter) and showed a LVEF 54%. Coronary calcification showed no progression and no need for intervention.
Pre-Procedural Work-Up
Severe AR represented the main pathology leaving the patient with significant symptomatic valvular heart disease. As further diagnostic work-up a CT scan was performed. Here, a bicuspid aortic valve (BAV) anatomy was seen with fused R/N cusps, while potential femoral access for transcatheter based treatment seemed feasible. However, apart from the raphe there was almost no calcification of the aortic valve. Given the increased surgical risk of the patient, heart team decision was to treat the patients by means of transfemoral TAVI.
Procedure
Due to the non-calcific form of the aortic disease, TAVI using a dedicated device for pure AR, namely the JV system size L 27mm, was planned. Transfemoral access was obtained in standard fashion. Balloon-valvuloplasty using a 23mm VACS III balloon was performed and then the long sheath of the JV was placed above the diseased aortic valve. The three locators, which “clip” the device onto the aortic valve were exposed and brought down towards the valve. Isolating each cusp, the R/N fused ones as well as the single L one, and confirming placement by root shoots with an MP catheter (used instead of a pigtail to not entangle with the locators) placement was confirmed. After proper positioning the self-expandable device was released. Following release fluoroscopically para-valvular leackage was evident and circular device expansion seemed sub-optimal. Thus, post-dilatation using a 25mm TD balloon (BD Medical) was performed. Afterwards PVL was resolved and the valve showed good hemodynamic performance (mean gradient: 7mmHg). The patient showed an uncomplicated post-procedural course and was discharged on the third post-operative day.
Conclusion
This is the first report of this dedicated device to treat pure AR for the use in a bicuspid aortic valve, showing technical feasibility of the “clippable” anchoring mechanism and effectiveness in the elimination of AR. More data on the use of this device in such anatomies needs to be aggregated and potentially also the role of leaflet modification (i.e., splitting of bicuspid leaflets), which could represent a treatment pathway to optimize implantation of the device in bicuspid anatomies should be explored.
