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(Circulation. 2003;108:1795.)
© 2003 American Heart Association, Inc.
Brief Rapid Communications |
From Wynn Department of Metabolic Cardiology (D.M.K.) and the Cardiac Division (D.M.K., M.B., J.P.), Baker Heart Research Institute, Melbourne, Victoria, Australia; and Cardiac Dimensions, Inc (C.A.), Kirkland, Wash.
Correspondence to Associate Professor David Kaye, Wynn Department of Metabolic Cardiology, Baker Heart Research Institute, P.O. Box 6492, St Kilda Rd Central, Melbourne, Victoria 8008, Australia. E-mail d.kaye{at}alfred.org.au
Received March 5, 2003; de novo received June 18, 2003; revision received August 22, 2003; accepted August 22, 2003.
| Abstract |
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Methods and Results CHF and MR were induced in 9 adult sheep by rapid ventricular pacing for 5 to 8 weeks. A mitral annular constraint device was implanted percutaneously through the right internal jugular vein in the coronary sinus and great cardiac vein to create a short-term stable reduction (24.9±2.5%) in the mitral annular septal-lateral dimension as assessed echocardiographically. Right and left heart pressures and cardiac output were determined before and 15 minutes after device implantation. MR extent was examined echocardiographically and expressed as a ratio of left atrial area (MR/LAA). After device placement, MR was substantially reduced from an MR/LAA of 42+6% to 4±3% (P<0.01). In association, mean pulmonary wedge pressure was significantly reduced (26±3 to 18±3 mm Hg; P<0.01) and mean cardiac output significantly increased (3.4±0.3 to 4.3±0.4 L/min; P=0.01).
Conclusions In this model of CHF, percutaneous placement of a mitral annular constraint device in the coronary sinus resulted in the short-term elimination or minimization of MR and was accompanied in the short term by favorable hemodynamic effects.
Key Words: regurgitation heart failure, congestive catheterization mitral valve
| Introduction |
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,9 which could also influence the outcome of CHF.10,11 The presence of functional MR in CHF also contributes substantially to the development of symptoms. During exercise, load-dependent increases in regurgitant fraction develop in conjunction with substantial elevations in pulmonary arterial pressures and blunted forward cardiac output responses.12 In CHF without primary valvular pathology, various therapeutic approaches have been used, including pharmacological and surgical approaches. To date, the full potential role of anatomic intervention on the mitral valve in CHF has been limited in most centers by virtue of the relatively high associated operative mortality rate.13 Nevertheless, recent data suggest that in patients with moderate to severe symptoms of CHF, surgical correction of MR can provide long-term benefit.14 Most typically, this is achieved by placement of an annuloplasty ring in an effort to reduce the mitral valve annulus and to improve coaptation of the valvular leaflets.
Given concerns about the mortality associated with primary mitral valve surgery in CHF, we have developed a strategy for the percutaneous insertion of a device placed in the coronary sinus (CS) and great cardiac vein that could be used to reduce MR in the setting of CHF.
| Methods |
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Device Implantation and Hemodynamic Assessment
On the day of device implantation, the pacemaker rate was reduced below the underlying native rhythm. Approximately 30 minutes later, the animals were anesthetized with bolus propofol (4 mg/kg intravenously) followed by a continuous intravenous infusion of 15 mg/kg ketamine per hour and 30 mg/kg propofol per hour in conjunction with positive pressure ventilation. All animals were placed in the left lateral decubitus position and underwent transthoracic echocardiography. Left atrial cross-sectional area and mitral annular dimensions were measured in the parasternal long-axis view. The extent and area of the regurgitant jet was assessed using color Doppler echocardiography. A 9F introducer sheath was subsequently positioned in the right internal jugular vein. A flow-directed thermodilution (Swan-Ganz, Baxter-Edwards) catheter was positioned for the determination of pulmonary arterial pressures and cardiac output. An 8F guide sheath containing the device was subsequently placed in the CS and advanced along the great cardiac vein to the level of the anterior interventricular vein. A novel mitral annular constraint device (Figure) was then placed in the CS/great cardiac vein. The device is constructed of nitinol wire with distal and proximal anchors connected by an intervening cable. The distal anchor was first deployed from the guide sheath into the distal great cardiac vein and locked in position. Tension was then applied to the device such that there was a reduction in the underlying mitral annular diameter of
25%. The tension was maintained while the proximal anchor was deployed into the body of the CS and locked in position. The echocardiographic and hemodynamic assessments were then repeated.
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The investigation conforms with the Guide for the Care and Use of Laboratory Animals published by the US National Institutes of Health (NIH Publication No. 82-23, revised 1996).
Statistical Methods
Data are presented as mean±SEM. Within-subject responses were analyzed using a paired t test. A probability value <0.05 was considered statistically significant.
| Results |
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| Discussion |
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The present study was performed in a well-characterized model of CHF, in which the major cause of MR has been previously shown to be annular dilatation and subsequent loss of leaflet coaptation.1 As a corollary, further studies will focus on determining whether this novel approach is applicable to MR that accompanies other forms of cardiomyopathy, particularly that resulting from ischemic heart disease.
Study Limitations
In the present study, we only evaluated the short-term hemodynamic effects of percutaneous mitral annular reduction in an experimental model in which MR developed secondary to pacing-induced left ventricular dilatation. Accordingly, we cannot comment about the long-term efficacy of this therapy alone, or in comparison to medical or surgical therapy for heart failure-associated MR. In this study, we used a relatively short-term model of MR, and device deployment was accompanied by significant reductions in both wedge pressure and pulmonary artery pressure. In the setting of chronic severe MR, it is conceivable that chronic increases in the pulmonary vascular resistance could limit the reduction in pulmonary artery pressure. The significance of this remains unclear because chronic remodeling of the pulmonary vasculature could occur some time after reduction of MR. Nevertheless, the hemodynamic benefit that we observed in the present study resulted in a similar improvement in cardiac output as that seen chronically with surgical mitral annuloplasty.20
Conclusion
We have shown for the first time that placement of a mitral annular constraint device in the CS has the potential to substantially reduce MR in an experimental model of dilated cardiomyopathy. This was well tolerated in the short term and accompanied by favorable hemodynamic effects. Further detailed studies are required to evaluate the tolerability and effectiveness of this novel therapy on left ventricular function in the long term.
| Acknowledgments |
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| Footnotes |
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| References |
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