Cedars-Sinai Leads the Way with First-In-Human Experience of Promising Transcatheter Mitral Valve Therapy
Nov 18, 2021 Cedars-Sinai Staff
After the success and worldwide adoption of transcatheter aortic valve implantation (TAVI) to treat aortic stenosis, the percutaneous replacement of a diseased mitral valve has rapidly become a goal for physicians looking to improve outcomes for these patients. Mitral valve disease is more common than aortic stenosis, and the surgical approach remains the gold standard treatment for degenerative mitral regurgitation (MR), whereas patients with functional MR are often helped by transcatheter therapy with the MitraClip device. In certain patients, for whom surgery is not appropriate and medical therapy is not sufficient, transcatheter mitral valve replacement may mature as a reliable, safe and reproducible therapeutic option to improve both quality of life and avoid hospital admissions.
Over the past decade, the interventional cardiologists at Cedars-Sinai have led developments in transcatheter therapies for heart valve disease and have the greatest experience within the United States in treating both the mitral and the aortic valve. This experience makes our team ideally suited to lead future advances with new technologies to improve outcomes.
Raj Makkar, MD, an interventional cardiologist at Cedars-Sinai and the Stephen R. Corday, MD, Chair in Interventional Cardiology, is the national principal investigator of the MISCEND study—an evaluation of a novel device (Eos Valve, Edwards Lifesciences, Irvine, California) to treat clinically significant, symptomatic mitral valve disease with transcatheter mitral valve replacement in patients who are unsuitable for conventional open-heart surgery.
"With this procedure, interventional cardiologists are able to accomplish what the surgeons do, but without opening the chest"
Using this therapy, the heart is accessed by placing a catheter in a vein in the patient’s leg, as operators carefully guide the new valve into position. This valve is precisely deployed to ensure a good result and then is released. The valve is fully repositionable and recapturable, allowing for it to be adjusted or removed if necessary. After the valve is released and the catheters are removed, the patient returns to the floor and can walk the same day with a normally functioning valve. Typically, patients stay one or two nights post-procedure to recover before being discharged and returning home.
"With this procedure, interventional cardiologists are able to accomplish what the surgeons do, but without opening the chest," says Makkar.
Makkar has treated the first seven patients in the world with this device and has seen excellent results with regards to safety and reduction in mitral valve disease. All seven of the patients were unsuitable for conventional open-heart surgery and have limiting symptoms despite medical therapy. Interestingly, they include patients who had failed previous attempts at other transcatheter therapies to repair or replace the valve, highlighting the utility of the device.
"There has been a huge paradigm shift over the last five years where doctors can offer patients with mitral valve disease a variety of options, including both mitral valve repair and replacement," says Makkar. "The Eos device is the next steppingstone to improve options and outcomes for selected patients."
A 67-year-old woman with a history of atrial fibrillation, hypothyroidism and morbid obesity was referred with shortness of breath on activity due to significant mitral regurgitation.
She was unable to perform more than 10 minutes of work in her yard due to shortness of breath and struggled to lie flat due to her heart failure. Given her comorbidity, she was considered high risk for open-heart surgery and would most likely need a prolonged period of recovery.
Due to this, she was considered for transcatheter therapies and was assessed with ultrasound studies and a CT scan before being treated with the Eos device. She had suitable anatomy and in May 2021, she underwent transcatheter mitral valve replacement with a 44 mm device, experiencing an excellent result.
She had a two-night hospital stay and was discharged home already feeling less short of breath. She has continued her improvement and was recently seen in the clinic with much more energy, less shortness of breath and the ability to lie flat. Scans of her heart demonstrated that the leakiness of her heart valve had completely resolved.