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Endoventricular shaper supports reproducibility of outcomes and decreased mitral regurgitation with Surgical Ventricular Restoration (SVR). Authors: Tea Acuff, MD; Steven Boyce, MD; John Conte, MD; Marisa Di Donato, MD; and Lorenzo Menicanti, MD STUDY DESIGN INTRODUCTION TR3ISVR SURGICAL VENTRICULAR RESTORATION PROCEDURE The TR3ISVR™ procedure helps to ensure predictable and reproducible outcomes. To restore the ventricle to its more anatomically correct size, shape and orientation, the Mannequin™, (Chase Medical, Richardson, TX) an endoventricular shaping device, is inserted into the ventricle allowing for optimization of volume, identification of the position of the new apex, and restoration of a more normal elliptical shape. The correctly sized shaper is inserted into the ventricle following incision of the akinetic or scar tissue area of the ventricle. Sizing is determined using the BSA of each individual patient. The basal portion of the shaper is seated against the aortic and mitral valve annuluses and placement of the tip of the Mannequin clearly identifies the new apex location of the reshaped ventricle. The Mannequin serves as an outline for the suturing and patch placement in forming the more elliptically shaped ventricle. AGGREGATE U.S. AND INTERNATIONAL RETROSPECTIVE INITIAL EXPERIENCE NYHA Classification Pre and Post Baseline Patient Characteristics M= F= 82.5% 17.6% 80 70 60 50 40 30 20 10 0 % PRE % POST Mitral Regurgitation I Age n = 139 < 45 = 45 - 54 = 55 - 64 = 65 - 74 = 75 - 85 = Mean = StDev = I= II = III = IV = 10 - 20 = 21 - 30 = 31 - 40 = 2.9% 16.5% 30.2% 33.2% 17.3% 64.1 10.3 IV 5.7% 25.7% 34.3% 34.3% n = 70 Percent Of Total Population NYHA Classification I II III IV Mean = StDev = 3 Pre Post 5.7% 25.7% 34.3% 34.3% 25.7% 68.6% 5.7% 0% DISCUSSION 1.24 1 0.57 Pre n = 103 Size, Shape and Orientation are Key Post Degree of Mitral Regurgitation Mean = Pre Post 1.24 0.57 Mean = StDev = Mitral Regurgitation Percent of Total (n = 103) Mean 39.1 StDev 10.3 Mean 31.5 StDev 8.4 Degree Pre None I (Trivial) II (Mild) III (Moderate) IV (Severe) Post Pre Post 31.5 8.4 39.1 10.3 Pre Post 21% 56% 10% 6% 7% 45% 48% 7% 0% 0% The TR3ISVR Procedure Progression of Heart Failure 1. Normal heart Copyright © 2003, Chase Medical and the Chase Medical logo are registered service marks of Chase Medical. Reshaping the Future, TR3ISVR, Mannequin, and SVR are trademarks and registered trademarks of Chase Medical. When surgically re-sizing the ventricle without the use of a shaping device, the surgeon must estimate the resulting size and final ventricular volume. Three outcomes are possible: the resulting ventricle is too small, too large or the correct size. Making the ventricle too small is the worst scenario, because it will lead to immediate pulmonary hypertension (Dor, Seminars in Thoracic and Cardiovascular Surgery, Vol. 13, #3, Oct 2001). Making the ventricle too large leaves the patient’s heart in a state similar to its pre-operative condition and may fail to arrest the continuing deterioration of the patient’s condition. Though it is possible, restoring the ventricle to the optimal size without the use of a Mannequin may be dangerous. Shaping the ventricle is even more difficult. It is a “3-D tailoring” challenge (Jatene, JTCS, Vol. 89 #3, March 1985) where the surgeon “imagines” to what shape the ventricle should be restored. Use of the Mannequin device ensures that each TR3ISVR procedure will result in an optimal elliptically shaped ventricle. Mitral valve apparatus misalignment causes mitral regurgitation (Aikawa et. al., The severity of functional mitral regurgitation depends on the shape of the mitral apparatus, presented at AHA 1998) and reduces the ability of the mitral valve apparatus to assist in the contraction of the ventricle. Restoring the proper shape of the ventricle helps restore this orientation and enables the ventricle and mitral valve to function more efficiently and reduces the amount of work required by the papillary muscles. CONCLUSION Elliptical Ventricle formed with an Endoventricular Shaping Device NewEra2004 Cardiac Care: Innovation and Technology - January 9-11, 2004 A multi-center retrospective evaluation of pre-operative and post-operative functional data for 153 patients who underwent the TR3ISVR procedure with the Mannequin was completed in September 2003. Graphical representation of the reviewed data was prepared and reviewed at the TR3ISVR Registry Principal Investigators Meeting held concurrent to the 2003 Heart Failure Society of America meeting in Las Vegas, Nevada on September 21-24, 2003. Patient characteristics reviewed included: gender, age and New York Heart Association (NYHA) classification. Functional measurements were reported using degree of mitral valve regurgitation and ejection fraction pre-and post-operatively. 2 Mean LVEF 45 40 35 30 25 20 15 10 5 0 7.7% 46.2% 16.5% 78.5 33.6 4 0 Ejection Fraction Pre and Post n = 91 LVESVI n = 114 III NYHA Classification NYHA n = 70 LVEF n = 91 II Degree of Regurg Gender n = 153 Mitral Regurgitation Pre and Post NYHA % of Total Clinical research has shown that the progressive degradation of physiologic function, diminished quality of life, repeated hospitalizations and early mortality associated with congestive heart failure (CHF) are direct consequences of a dilated spherical ventricle with limited contractile and filling capacities. A variety of studies have demonstrated the success of SVR® in treatment of dilation of the post-infarcted ventricle. However, restoration of normal ventricular shape presented a challenge and resulted in the introduction of secondary mitral regurgitation. Initial SVR procedures were performed using only a cardiovascular patch; while the recent introduction of an endoventricular shaping device to assist the surgeon in restoring the ventricle to its normal elliptical shape has resulted in improved functional and clinical outcomes. Mannequin 2. Damaged left ventricle 3. Dilated left ventricle Dyskinetic/Akinetic scar Location of Fontan suture at transition area Tighten Fontan suture for correct size and shape Surgical ventricular restoration using a Mannequin allows the surgeon to restore elliptical shape, to optimally resize and to reorient the ventricle in the ischemic heart failure patient. This replicable process produces consistent outcomes with a decrease in degree of mitral regurgitation. Functional improvements have been measured using ejection fraction and mitral regurgitation measurements in this retrospective study. Further studies will provide additional key indicators useful in patient selection for this procedure.