The German-developed JenaValve transcatheter heart valve may serve as an adequate option for treating severe aortic regurgitation, however, "a significant early non-cardiac mortality related to the high-risk population emphasizes the need for careful patient selection," according to a study published Aug. 13 in JACC: Cardiovascular Interventions.

Additional Resources TAVR Resource Center Interventional Clinical Collection Interventional Member Section

The study was led by Moritz Seiffert, MD, Departments of General and Interventional Cardiology and Cardiovascular Surgery, University Heart Center Hamburg, Germany, who conducted a multicenter study on the JenaValve implant for the treatment of pure aortic regurgitation in patients at high risk for surgery.

His team performed the therapy in 31 patients (age 73.8 ± 9.1 years) in nine different centers, and results showed implantation was successful in 30 of the total cases. Transcatheter heart valve dislodgement necessitated a valve-in-valve implantation in one patient. Post-procedure, aortic regurgitation was measured as absent/trace in 28 of the 31 patients, and was mild in three patients. In the event of patient follow-up, two underwent valvular re-interventions.

Ultimately all-cause mortality was 12.9 percent and 19.3 percent at 30 days and six months respectively. In the study's remaining patients, significant improvement in the New York Heart Association class was observed and persisted up to six months after the procedure.

With the JenaValve featuring a clip fixation of the native aortic valve cusps, offering secure anchorage of the transcatheter heart valve even in the absence of calcification, Seiffert et al. believe the modified prosthesis is a promising therapy for those prone to aortic regurgitation, but caution that moving forward, continued observation is warranted to confirm long-term valve function.

Keywords: Heart Valve Prosthesis, Surgical Instruments, Follow-Up Studies, Patient Selection

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