Volume 390, Issue 10096, Pages (August 2017)

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Volume 390, Issue 10096, Pages 773-780 (August 2017) Compassionate use of the PASCAL transcatheter mitral valve repair system for patients with severe mitral regurgitation: a multicentre, prospective, observational, first-in-man study Fabien Praz, MD, Konstantinos Spargias, MD, Michael Chrissoheris, MD, Lutz Büllesfeld, MD, Prof Georg Nickenig, MD, Florian Deuschl, MD, Robert Schueler, MD, Neil P Fam, MD, Robert Moss, MD, Moody Makar, MD, Robert Boone, MD, Jeremy Edwards, MD, Aris Moschovitis, MD, Saibal Kar, MD, Prof John Webb, MD, Ulrich Schäfer, MD, Prof Ted Feldman, MD, Prof Stephan Windecker, MD The Lancet Volume 390, Issue 10096, Pages 773-780 (August 2017) DOI: 10.1016/S0140-6736(17)31600-8 Copyright © 2017 Elsevier Ltd Terms and Conditions

Figure 1 Procedural sequence of the Edwards PASCAL transcatheter mitral valve repair system (A) Illustration showing the introduction of the implant into the left atrium. (B) Fluoroscopy image showing the unfolded PASCAL device. (C) Fluoroscopy image showing the device being folded to reduce its length. (D) Flexion of the steerable catheter and orientation of the device towards the mitral valve. (E) Three-dimensional echocardiographical view of the mitral valve from the left atrium with the PASCAL system oriented towards the valve. (F) Deployment of the PASCAL device. (G) After deployment of the device, a double orifice mitral valve is typically created. LA=left atrium. LV=left ventricle. MV=mitral valve. The Lancet 2017 390, 773-780DOI: (10.1016/S0140-6736(17)31600-8) Copyright © 2017 Elsevier Ltd Terms and Conditions

Figure 2 Procedural and 30 day echocardiogram results Echocardiogram images before the procedure (A), immediately after the procedure (B), and 30 days after implantation (C) of one PASCAL device in a patient with severe functional mitral regurgitation and short posterior leaflet (6 mm). Echocardiogram images before the procedure (D), immediatley after the procedure (E), and 30 days after the procedure (F) in a patient with severe mixed mitral regurgitation (prolapse of the posterior leaflet and ventricular dilation with left ventricular ejection fraction of 30%). LA=left atrium. LV=left ventricle. Asterisks (*) show the spacer. The Lancet 2017 390, 773-780DOI: (10.1016/S0140-6736(17)31600-8) Copyright © 2017 Elsevier Ltd Terms and Conditions

Figure 3 Clinical and functional outcomes of patients 30 days after device implantation (A) Severity of mitral regurgitation in patients at baseline, discharge, and 30 days. (B) NYHA class of patients with mitral regurgitation at baseline and 30 days after device implantation. For (A) and (B), the Wilcoxon signed-rank test was used to test for statistical significance among paired values (n) and for the calculation of effect size, denoted by Cohen's d. (C) Results of the 6 min walk test done in a subgroup of 11 patients with paired data. Paired t test was used to test for statistical significance and for the calculation of effect size, denoted by Cohen's d. Boxes indicate the 25–75th percentiles, whiskers represent the minimum and maximum values, and solid lines within the boxes represent the median values. d=Cohen's effect size. NYHA=New York Heart Association. The Lancet 2017 390, 773-780DOI: (10.1016/S0140-6736(17)31600-8) Copyright © 2017 Elsevier Ltd Terms and Conditions