First-in-human results presented Thursday show that the novel transseptal EVOQUE transcatheter mitral valve replacement system is feasible, with high implant success, low complication rates and reduced mitral regurgitation (MR) at 30 days.
John G. Webb, MD, of St. Paul’s Hospital, Vancouver, British Columbia, presented the initial experience of the first 14 patients treated with the EVOQUE system on behalf of the investigators at the PCR e-Course. The results were simultaneously published online in JACC: Cardiovascular Interventions.
In recent years, several new devices have been developed to allow a less-invasive option than surgery for the treatment of mitral regurgitation. The EVOQUE valve has a self-expanding nitinol frame, bovine pericardial leaflets and fabric skirt to minimize paravalvular leak. In addition, the valve has a unique anchoring mechanism to utilize the annulus, leaflets and chords for secure placement in the anatomy. Available in two sizes (44 mm and 48 mm), the valve is delivered through a 28-Fr delivery sheath via a transseptal puncture.
The study enrolled 14 patients between September 2018 and October 2019 with greater than moderate mitral regurgitation who were deemed to be of prohibitive risk for surgery. The median age of the patients was 84 years. Patients with degenerative, functional and mixed mitral valve disease were included.
The authors report that technical success was achieved in 13 patients. One patient was converted to open surgery. At 30-day follow up, the authors reported one non-cardiovascular death, two strokes, no myocardial infarctions and no repeat hospitalizations. Two patients had to undergo additional closure of a paravalvular leak, and one patient required an alcohol septal ablation to reduce a left ventricular outflow tract obstruction. More than 80% of patients had less than or equal to mild mitral regurgitation at follow-up, with an associated improvement in their New York Heart Association functional class.
“This first-in-human experience has demonstrated the feasibility of the transseptal EVOQUE TMVR system,” Webb and colleagues conclude. “Further clinical studies are required to establish safety and clinical outcomes.”
Webb added in his PCR e-Course presentation that an early feasibility study is currently enrolling.
The study was funded by Edwards Lifesciences.
PCR e-Course is the virtual meeting being held in place of the annual in-person EuroPCR congress, which was canceled because of the COVID-19 pandemic.