Favorable 30-day safety and clinical outcomes were observed in patients with high surgical risk and moderate-severe/severe mitral regurgitation (MR) who were treated with the Intrepid transfemoral transcatheter mitral valve replacement (TMVR) system, according to early feasibility study results presented Nov. 6 during TCT 2021 and simultaneously published in JACC: Cardiovascular Interventions.

“Early 30-day results from the Intrepid transfemoral TMVR system demonstrated excellent valve function and safe transfemoral delivery of the valve, including favorable performance with no mortality, stroke, reintervention, or new pacemaker at 30 days, and a significant reduction in MR severity to trace or none in all implanted patients,” said Firas E. Zahr, MD, FACC, and colleagues.

The prospective, nonrandomized study evaluated the safety and performance of the Intrepid transfemoral TMVR system in 15 patients from six sites between February 2020 and May 2021. The median age was 80 years, 87% were male and 53% had prior sternotomy. The median stay post-procedure was five days and median follow-up was 30 days.

Overall, 14 implants were successful, with one patient converting to surgery. At 30 days there were no deaths, strokes or reinterventions and all implanted patients had trace or no valvular or paravalvular MR (mean gradient 4.7±1.8 mmHg). Six access site bleeds (40%) and 11 iatrogenic atrial septal defect closures (73%) were reported.

According to Zahr et al., the findings demonstrate “feasibility of this less invasive access route,” however, they add that larger trials and longer follow-up are needed to “evaluate this device and assess whether elimination of MR transform into reversal of left ventricular remodeling.” They also noted that quality of life survey data will also be important.

In a related editorial comment, Mohamad Alkhouli, MD, FACC; Mayra E. Guerrero, MD, FACC; and Charanjit S. Rihal, MD, write that the “excellent initial outcomes … bring transseptal TMVR one step closer to becoming a therapeutic option in our armamentarium for MR management. Although several questions remain, the future of transseptal TMVR seems bright.”

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Interventions and Imaging, Angiography, Nuclear Imaging

Keywords: Transcatheter Cardiovascular Therapeutics, TCT21, Mitral Valve, Heart Valve Prosthesis, Angiography

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