U S Department of Health and Human Services

U. S. Department of Health and Human Services Transcatheter mitral cerclage annuloplasty to treat functional mitral valve regurgitation Robert J. Lederman, MD National Institutes of Health National Heart, Lung, and Blood Institute Division of Intramural Research National Heart Lung and Blood Institute National Institutes of Health Bethesda, MD, USA lederman@nih. gov Disclosures : • No financial conflicts of interest. NIH & Siemens have a Collaborative R&D Agreement. • These are non-clinical or investigational procedures.

Inspiration: epicardial pursestring suture annuloplasty Glover & Davila, Circulation, 1957

Acknowledgements n n n June-Hong Kim, MD; Pusan University, Korea Ozgur Kocaturk, Ph. D; NHLBI Catheter Fab Christina Saikus, BS; NHLBI/Georgia Tech/Emory MSTP Anthony Faranesh, Ph. D; NHLBI Imaging Merdim Sonmez, BS; NHLBI Imaging Venkatesh Raman, MD; NHLBI J. Andrew Derybyshire, Ph. D; Cengizhan Ozturk, Ph. D, MD; Bogazici University, Istanbul William H. Schenke, BS, NHLBI Technologist Smita Sampath, Ph. D; Yale University Ann Kim, BS; NHLBI Student

The concept of mitral cerclage Kim JH et al JACC 2009; 54: 638

XFM guidance of cerclage

Cerclage technique 1: GCV angiogram 4: Septal traversal 2: Balloon occlusion 5: Snare 3: Microcatheter engage septal perforator 6: Snare, Tension, Lock

The concept of mitral cerclage Kim JH et al JACC 2009; 54: 638

Necropsy after RV cerclage septal reentry Viewed from right ventricle

Coronary artery compression & protection (-) Protection; 0 -400 g Tension D (+) Protection; 0 -800 g Tension

Cerclage-Annulus Planar Mismatch Compensates for Sinus-Annular Discordance Mitral annulus Cerclage Plane Coronary Sinus

Cerclage tension reduces annular dimensions Kim JH et al JACC 2009; 54: 638

Immediate impact of cerclage 40 p=0. 04 30 20 Categorical mitral regurgitation Regurgitation grade (1 -4) Regurgitant fraction (%) Mitral regurgitation measured using MRI II p<0. 01 I 1. 7 ± 0. 8 10 0. 7 ± 0. 5 (–) Tension (+) Tension Kim JH et al JACC 2009; 54: 638

Immediate impact of cerclage Kim JH et al JACC 2009; 54: 638

Potential Pitfalls n Tricuspid dysfunction – Trabecular entrapment – Mural leaflet entrapment n Myocardial erosion: unlikely n Unsuitable venous anatomy n Conduction system

U. S. Department of Health and Human Services Serendipitous findings National Institutes of Health National Heart, Lung, and Blood Institute

Reciprocal LVOT & MVA constraint by cerclage: Enhances coaptation while avoiding LVOT obstruction 2. 0 ± 0. 3 cm 2. 4 ± 0. 4 cm Diastole AV open AV closed MV open 1. 6 ± 0. 4 cm 2. 8 ± 0. 4 cm 4. 5 ± 0. 7 cm 4. 4 ± 0. 5 cm Systole

Improved leaflet coaptation and Apical displacement of posterior annulus Preserved annular dynamics

Humans usually have suitable septal perforator veins Kim JH et al JACC 2009; 54: 638

Summary: Cerclage Annuloplasty Circumferential tension around annulus n Treats mitral regurgitation in porcine ischemic cardiomyopathy n Novel features n – Coronary protection device – Annular-cerclage plane discordance – Reciprocal constraint of LVOT & Mitral annulus – Accommodates papillary traction n Simple and fun