We have begun multicenter testing of mitral cerclage annuloplasty to treat secondary mitral regurgitation in patients in the USA. We have continued preclinical development with an industry partner for our transauricular intrapericardial tricuspid annuloplasty (TRAIPTA) technique and device to treat secondary tricuspid regurgitation. We expect to begin USA early feasibility testing next year. We completed enrollment and primary reporting of a multicenter early feasibility study of a dedicated closure device for transcaval access developed by NHLBI in partnership with a small business. We completed enrollment and reporting of a multicenter early feasibility study of Bioprosthetic or native Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction after TAVR (BASILICA). We are leading education and proctorship, directly and in industry partnership, for this technique which has been applied to hundreds of patients worldwide. We completed enrollment and reporting of a multicenter early feasibility study of intentional Laceration of the Anterior Mitral leaflet to Prevent left ventricular Outflow ObstructioN (LAMPOON) after transcatheter mitral valve replacement. We have led education efforts. The technique has been applied to hundreds of patients worldwide. We developed and reported a LAMPOON-variant to allow TMVR after Alfieri-stitch (ELASTIC) and after mitra-clip (ELASTA-a-CLIP). The latter will prove important now that Mitra-Clip will be used more often to treat secondary mitral valve replacement. We continue education and proctorship for transcaval access, which has been performed across the globe in over 1000 patients to date.

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Support Year
10
Fiscal Year
2019
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National Heart, Lung, and Blood Institute
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Greenbaum, Adam B; Condado, Jose F; Eng, Marvin et al. (2018) Long or redundant leaflet complicating transcatheter mitral valve replacement: Case vignettes that advocate for removal or reduction of the anterior mitral leaflet. Catheter Cardiovasc Interv 92:627-632
Khan, Jaffar M; Rogers, Toby; Babaliaros, Vasilis C et al. (2018) Predicting Left Ventricular Outflow Tract Obstruction Despite Anterior Mitral Leaflet Resection: The ""Skirt NeoLVOT"". JACC Cardiovasc Imaging 11:1356-1359
Khan, Jaffar M; Dvir, Danny; Greenbaum, Adam B et al. (2018) Transcatheter Laceration of Aortic Leaflets to Prevent Coronary Obstruction During Transcatheter Aortic Valve Replacement: Concept to First-in-Human. JACC Cardiovasc Interv 11:677-689
Khan, Jaffar M; Rogers, Toby; Eng, Marvin H et al. (2018) Guidewire electrosurgery-assisted trans-septal puncture. Catheter Cardiovasc Interv 91:1164-1170
Babaliaros, Vasilis; Greenbaum, Adam B; Kamioka, Norihiko et al. (2018) Bedside Modification of Delivery System for Transcatheter Transseptal Mitral Replacement With POULEZ System and SAPIEN-3 Valve. JACC Cardiovasc Interv 11:1207-1209
Khan, Jaffar M; Rogers, Toby; Schenke, William H et al. (2018) Transcatheter pledget-assisted suture tricuspid annuloplasty (PASTA) to create a double-orifice valve. Catheter Cardiovasc Interv 92:E175-E184
Khan, Jaffar M; Lederman, Robert J; Sanon, Saurabh et al. (2018) Transcatheter Mitral Valve Replacement After Transcatheter Electrosurgical Laceration of Alfieri STItCh (ELASTIC): First-in-Human Report. JACC Cardiovasc Interv 11:808-811
Rogers, Toby; Lederman, Robert J (2018) Percutaneous transaxillary access for TAVR: Another opportunity to stay out of the chest. Catheter Cardiovasc Interv 91:157-158
Kasel, A Markus; Rumpf, Moritz; Frangieh, Antonio H et al. (2018) International LAMPOON: first European experience with laceration of the anterior mitral valve leaflet prior to transseptal transcatheter mitral valve implantation. EuroIntervention 14:746-749
Khan, Jaffar M; Lederman, Robert J (2018) Transcatheter electrosurgery in bipolar or monopolar modes. Catheter Cardiovasc Interv 91:1052-1053

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