Key result
Transapical Direct Flow Medical TMVR improves functional status to functional class I-II without LVOT obstruction.
Why the study?
High surgical risk precluded conventional surgery in a patient with severe mitral valve stenosis and circumferential mitral annular calcification, prompting first-in-man transapical mitral valve replacement using a repositionable non-metallic Direct Flow Medical aortic valve prosthesis.
Case Report (n=1)
No
This first-in-man case demonstrates that severe mitral valve stenosis with circumferential mitral annular calcification can be feasibly treated via transapical mitral valve replacement using a repositionable Direct Flow Medical aortic valve prosthesis in selected high-risk patients.
Answers are grounded in this paper and cite their sources.
Feasibility shown in high-risk mitral annular calcification; leaves open safety, durability, and generalizability in larger cohorts.
F.M. and J.-M.S. contributed equally to the manuscript. F.M. and J.-M.S. contributed equally to the manuscript. A 74-year-old male presented with progressive dyspnoea NYHA functional class III–IV. Echocardiography revealed severe mitral valve (MV) stenosis with an MV area of 0.6 cm2 (Panel A) and an increase in systolic pulmonary artery pressure from 36 to 75 mmHg during exercise stress echocardiography. Multi-slice computed tomography (MSCT) showed a circumferential mitral annular calcification with involvement of both MV leaflets (Panel B, MSCT of MV annulus: perimeter 90.6 mm). Due to high surgical risk (STS score 6.8%) with a history of surgical aortic valve replacement and coronary artery bypass grafting in 2006, the Heart Team decided for transcatheter MV replacement (TMVR) via transapical access. A 26 mm balloon valvuloplasty catheter was used for predilation and sizing simultaneously to left ventriculography (Panels C and D, see Supplementary material online, Videos 1 and 2). Due to MV annulus size and shape, the non-metallic Direct Flow Medical® (DFM) (Direct Flow Medical, Santa Rosa, CA, USA) valve was chosen and implanted transapically under transoesophageal echocardiographic (TEE) and fluoroscopic guidance with a pigtail catheter in the left ventricle to rule out relevant left ventricular outflow tract (LVOT) obstruction. This valve is repositionable and fully recapturable in case of LVOT obstruction or intolerable paravalvular leckage. 3D-TEE and fluoroscopy confirmed proper valve positioning with mild paravalvular mitral regurgitation (MR) after valve expansion (Panel E), without relevant residual stenosis or LVOT obstruction (Panel F, see Supplementary material online, Videos 3 and 4). After the procedure, the patient improved significantly (NYHA I-II). The case demonstrates that MV disease with severely calcified MV annulus may be treated by TMVR with a repositionable transcatheter aortic valve prosthesis in selected high risk patients. Supplementary material is available at European Heart Journal online.
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Mellert et al. (2015) conducted a case report in Severe mitral valve stenosis with circumferential mitral annular calcification (n=1). Transapical mitral valve replacement using the Direct Flow Medical aortic valve prosthesis was evaluated on Valve positioning, residual mitral regurgitation/stenosis, LVOT obstruction, and NYHA functional class improvement. Transapical mitral valve replacement using the Direct Flow Medical prosthesis improved functional status from NYHA III-IV to I-II with mild paravalvular regurgitation and no LVOT obstruction.
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