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J Am Coll Cardiol, 2009; 54:638-651, doi:10.1016/j.jacc.2009.03.071
© 2009 by the American College of Cardiology Foundation
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PRE-CLINICAL RESEARCH

Mitral Cerclage Annuloplasty, A Novel Transcatheter Treatment for Secondary Mitral Valve Regurgitation

Initial Results in Swine

June-Hong Kim, MD*,{dagger}, Ozgur Kocaturk, MSc*, Cengizhan Ozturk, PhD, MD*,{ddagger}, Anthony Z. Faranesh, PhD*, Merdim Sonmez, MSc*,{ddagger}, Smita Sampath, PhD*, Christina E. Saikus, BS*, Ann H. Kim, BS*, Venkatesh K. Raman, MD*, J. Andrew Derbyshire, PhD*, William H. Schenke, BS*, Victor J. Wright, BS*, Colin Berry, PhD, MD*, Elliot R. McVeigh, PhD* and Robert J. Lederman, MD*,*

* Translational Medicine Branch, Division of Intramural Research, National Heart Lung and Blood Institute, National Institutes of Health, Bethesda, Maryland
{dagger} Cardiology Division, Pusan National University, Busan, Korea
{ddagger} Department of Biomedical Engineering, Bogazici University, Istanbul, Turkey

Manuscript received November 23, 2008; revised manuscript received March 9, 2009, accepted March 10, 2009.

* Reprint requests and correspondence: Dr. Robert J. Lederman, Translational Medicine Branch, Division of Intramural Research, National Heart Lung, and Blood Institute, National Institutes of Health, Building 10, Room 2c713, Bethesda, Maryland 20892-1538 (Email: ledermar{at}nhlbi.nih.gov).

Objectives: We developed and tested a novel transcatheter circumferential annuloplasty technique to reduce mitral regurgitation in porcine ischemic cardiomyopathy.

Background: Catheter-based annuloplasty for secondary mitral regurgitation exploits the proximity of the coronary sinus to the mitral annulus, but is limited by anatomic variants and coronary artery entrapment.

Methods: The procedure, "cerclage annuloplasty," is guided by magnetic resonance imaging (MRI) roadmaps fused with live X-ray. A coronary sinus guidewire traverses a short segment of the basal septal myocardium to re-enter the right heart where it is exchanged for a suture. Tension is applied interactively during imaging and secured with a locking device.

Results: We found 2 feasible suture pathways from the great cardiac vein across the interventricular septum to create cerclage. Right ventricular septal re-entry required shorter fluoroscopy times than right atrial re-entry, which entailed a longer intramyocardial traversal but did not cross the tricuspid valve. Graded tension progressively reduced septal-lateral annular diameter, but not end-systolic elastance or regional myocardial function. A simple arch-like device protected entrapped coronary arteries from compression even during supratherapeutic tension. Cerclage reduced mitral regurgitation fraction (from 22.8 ± 12.7% to 7.2 ± 4.4%, p = 0.04) by slice tracking velocity-encoded MRI. Flexible cerclage reduced annular size but preserved annular motion. Cerclage also displaced the posterior annulus toward the papillary muscles. Cerclage introduced reciprocal constraint to the left ventricular outflow tract and mitral annulus that enhanced leaflet coaptation. A sample of human coronary venograms and computed tomography angiograms suggested that most have suitable venous anatomy for cerclage.

Conclusions: Transcatheter mitral cerclage annuloplasty acutely reduces mitral regurgitation in porcine ischemic cardiomyopathy. Entrapped coronary arteries can be protected. MRI provided insight into the mechanism of cerclage action.

Key Words: image-guided intervention • catheter-based intervention, noncoronary • magnetic resonance imaging • multimodality image fusion

Abbreviations and Acronyms
  CT = computed tomography
  MRI = magnetic resonance imaging


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