Reviewer: Dr. Ekrem Şahan

Study: JenaValve Trilogy for the Treatment of Aortic Regurgitation: First Worldwide Results

Published in Congress: EUROPCR 2022

Introduction: Transcatheter aortic valve replacement (TAVR), which is currently a treatment option for severe aortic stenosis, may now be a treatment option for aortic regurgitation in the light of updated data. In studies on aortic regurgitation (AR), valve prostheses designed for calcified aortic stenosis were used, and the implantation process was problematic in patients without adequate calcification. After the new results obtained from Europe recently, the Trilogy heart valve system (JenaValve Technology) was indicated for use in aortic insufficiency and aortic stenosis with CE approval in Europe about 1 year ago. The United States Food and Drug Administration awaits the ALIGN-AR study results.

Objective: Aortic valve calcification, which plays an important role in the involvement of the aortic valve in the TAVR procedure, is absent in some patients with aortic regurgitation and makes implantation of the TAVR prosthesis impossible. However, the clip system attached to the native aortic valves in the Trilogy valve system allows implantation in these patients with aortic insufficiency without calcified valves and reduces the rate of paravalvular leak. The aim of the study is to reveal the results of the Trilogy valve system in severe non-calcific aortic regurgitation.

Methods: Patients with aortic insufficiency in six different centers in Germany were included in the study. All patients included in the study had moderate-to-severe or severe aortic regurgitation. The mean age of patients was 77 years, 40% of patients were female, and the mean EuroSCORE II was 7.1%. Seven out of 10 patients had functional capacity to be NYHA class III or IV. Approximately one-third of patients had previous cardiac surgery, more than half (58%) had LVEF ≤ 50%. TAVR was performed via transfemoral access in all patients, most patients (82% of patients) underwent conscious sedation, mean procedure time 77 minutes. The mean fluoroscopy time was 19 minutes and the mean contrast dose was 180.58 mL. The valve diameters used were 27 mm in 60%, 25 mm in 31%, and 23 mm in 9%. Post-dilatation was performed in two cases.

Results: Successful implantation of the aortic valve with a mean gradient <20 mm Hg was performed after the procedure, and a reduction of one degree or more in aortic regurgitation, the primary efficacy endpoint, was achieved in 100% of patients. Stage 2/3 acute kidney injury did not develop in any patient. No major and/or life-threatening bleeding was observed and the rate of minor bleeding was 6.7%. A major vascular complication developed in one patient. Regarding safety, none of the patients required conversion to open surgery, and no cerebrovascular accident or death occurred. A pacemaker was required in nine patients. The mean aortic valve gradient at discharge was 4.04 mm Hg and the mean aortic valve area was 2.62 cm2. Most patients had no or minimal paravalvular regurgitation (56% and 36%, respectively), and 8.9% had mild paravalvular AR.

Conclusion: Severe aortic insufficiency patients who are unsuitable for SAVR or at high surgical risk were previously deprived of treatment options, but in line with these presented data, TAVR can be used as a therapeutic procedure for patients with severe aortic regurgitation. However, studies in larger patient populations are needed.

Comment: TAVR is an important treatment option for patients with aortic stenosis at high risk for surgical aortic valve replacement. Similarly, TAVR may be a treatment option for patients with severe aortic regurgitation. TAVR prostheses designed for calcified aortic stenosis have been used in off-label procedures and small-scale studies before, and the absence of calcific annulus necessary for fixation of the aortic valve prevents optimum implantation in patients with aortic insufficiency. In the Trilogy valve system, the clip system attached to the naive valves eliminates the need for calcific annulus and is a treatment option for patients with severe non-calcific aortic insufficiency. One of the remarkable issues is the high need for permanent pacemaker after the procedure in study patients. This study, in which the data of 45 patients are presented, has shown that there is a chance for treatment for patients who do not have a chance for surgery and who do not have calcific structure. It would be appropriate to reinforce these results with large-scale studies.