Initial Experience of Transcatheter Mitral Valve Replacement

Study Questions:

What are the immediate and short-term results associated with a mitral transcatheter heart valve (FORTIS, Edwards Lifesciences)?


Three patients (71 ± 9 years, two men) underwent Edwards FORTIS transcatheter mitral valve replacement under a compassionate clinical use program. All patients had functional mitral regurgitation (MR) secondary to ischemic cardiomyopathy (left ventricular ejection fraction 25-30%, all with history of prior bypass surgery), and were considered to be at very high surgical risk (mean Society of Thoracic Surgeons [STS] score 9.3).


The procedure was performed using a transapical approach. The valve was successfully implanted in all three cases, with no major procedural complications. At hospital discharge, echocardiography revealed trace MR in two patients and no MR in one patient; the mean transmitral gradient was ≤4 mm Hg in all three patients. At 3-month follow-up, valve function remained unchanged, and transesophageal echocardiography and computed tomography revealed no evidence of structural failure. All patients had improved functional status and exercise capacity on 6-minute walk test, and all patients reported improved quality of life. At 6-month follow-up, all patients remained alive with New York Heart Association class ≤II, and without hospital re-admission for heart failure.


The authors concluded that transcatheter mitral valve replacement with the FORTIS valve is feasible and associated with a low complication rate, further concluding that optimal functional results were obtained acutely, and sustained at 6-month follow-up in all patients.


Unlike reported cases in which a transcatheter aortic valve device was implanted in the mitral position in the setting of dense annular calcification or a degenerated bioprosthesis, it might be feasible to use the FORTIS device in the setting of primary or secondary noncalcific MR. This first report of three patients with 6-month follow-up after transcatheter mitral valve replacement is encouraging, yet it might be premature to draw firm conclusions about procedural complication rates and clinical outcomes from this very small single-center experience. If positive results are borne out in a larger, multicenter trial or trials, then transcatheter mitral valve replacement with this or another device might provide an attractive alternative to the limited MR reduction afforded by transcatheter edge-to-edge repair.

Clinical Topics: Cardiac Surgery, Congenital Heart Disease and Pediatric Cardiology, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Valvular Heart Disease, Cardiac Surgery and CHD and Pediatrics, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Congenital Heart Disease, CHD and Pediatrics and Imaging, CHD and Pediatrics and Interventions, Acute Heart Failure, Interventions and Imaging, Interventions and Structural Heart Disease, Echocardiography/Ultrasound, Mitral Regurgitation

Keywords: Bioprosthesis, Cardiac Surgical Procedures, Coronary Artery Bypass, Echocardiography, Echocardiography, Transesophageal, Heart Defects, Congenital, Heart Failure, Heart Valve Diseases, Mitral Valve Insufficiency, Quality of Life, Tomography, Transcatheter Aortic Valve Replacement

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