Transapical Coaptation Plate for Functional Mitral Regurgitation: An In Vitro Study

A novel transapical coaptation plate (TCP) device was developed and anchored by sutures in the mitral valve to treat functional mitral regurgitation. The objective of this study was to test efficacy of the TCP in an in vitro model. Eight fresh porcine mitral valves were mounted in a left heart simulator to simulate functional mitral regurgitation by means of annular dilatation and asymmetrical or symmetrical papillary muscle (PM) displacement. Six polyurethane TCPs in thickness of 6.4(#1), 4.8(#2), 3.2(#3) mm and hardness of durometer 30 A (H) and 30 OO(S),were fabricated and labeled as H1, H2, H3 and S1, S2, S3, respectively. These TCPs were anchored by the sutures in the mitral annulus and left ventricle apex, and tested. Steady backward flow leakage in a hydrostatic condition and regurgitant volume in a pulsatile flow were measured before and after implantation of the TCPs. Mean regurgitant volume fractions in the asymmetric PM displacement were reduced significantly from 59.1 to 37.2% for H1, 43.2% for H2, 35.9% for S1 and 34.2% for S2 (p < 0.021), after implantation of the TCPs. No significant reduction in mitral regurgitation was seen for H3 and S3 (p > 0.067). Mitral regurgitation was mild in the symmetric PM displacement, and was not significantly reduced after implantation of the TCPs. In conclusion, the TCP anchored by the sutures in the mitral annulus and left ventricle apex functions successfully as a plug in the mitral valve leaflet gap. The TCP with thickness equal to or greater than 4.8 mm is effective to reduce functional mitral regurgitation. The TCP hardness has no effect on difference in reduction of functional mitral regurgitation.

[1]  R. Levine,et al.  Efficacy of Chordal Cutting to Relieve Chronic Persistent Ischemic Mitral Regurgitation , 2003, Circulation.

[2]  M. Carrier,et al.  Is a good perioperative echocardiographic result predictive of durability in ischemic mitral valve repair? , 2006, The Journal of thoracic and cardiovascular surgery.

[3]  P. Pibarot,et al.  Preoperative Posterior Leaflet Angle Accurately Predicts Outcome After Restrictive Mitral Valve Annuloplasty for Ischemic Mitral Regurgitation , 2007, Circulation.

[4]  Jeroen J. Bax,et al.  Restrictive mitral annuloplasty cures ischemic mitral regurgitation and heart failure. , 2008, The Annals of thoracic surgery.

[5]  E. Tayama,et al.  Edge-to-edge repair for mitral regurgitation: a clinical and exercise echocardiographic study. , 2008, The Journal of heart valve disease.

[6]  J. Solis-Martin Polymer Injection Therapy to Reverse Remodel the Papillary Muscles: Efficacy in Reducing Mitral Regurgitation in a Chronic Ischemic Model , 2008 .

[7]  Wei Sun,et al.  In vitro stretches of the mitral valve anterior leaflet under edge-to-edge repair condition. , 2009, Journal of biomechanical engineering.

[8]  Wei Sun,et al.  Effects of papillary muscle position on anterior leaflet stretches under mitral valve edge-to-edge repair. , 2009, The Journal of heart valve disease.

[9]  R. Levine,et al.  Polymer Injection Therapy to Reverse Remodel the Papillary MusclesClinical Perspective , 2010 .

[10]  Robert C Gorman,et al.  Posterior leaflet augmentation improves leaflet tethering in repair of ischemic mitral regurgitation. , 2011, European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery.

[11]  Robert C Gorman,et al.  Ischemic mitral regurgitation: a quantitative three-dimensional echocardiographic analysis. , 2011, The Annals of thoracic surgery.

[12]  A Novel Coaptation Plate Device for Functional Mitral Regurgitation: An In Vitro Study , 2014, Annals of Biomedical Engineering.

[13]  L. Svensson,et al.  Mitral Valve Regurgitation and Left Ventricular Dysfunction Treatment with an Intravalvular Spacer , 2015, Journal of cardiac surgery.

[14]  M. Acker,et al.  Repair or replace for severe ischemic mitral regurgitation: prospective randomized multicenter data. , 2015 .

[15]  M. Acker,et al.  Repair or replace for severe ischemic mitral regurgitation: prospective randomized multicenter data. , 2015, Annals of cardiothoracic surgery.

[16]  H. Ince,et al.  Meta-analysis of the usefulness of Mitraclip in patients with functional mitral regurgitation. , 2015, The American journal of cardiology.

[17]  Denis Bouchard,et al.  Predicting recurrent mitral regurgitation after mitral valve repair for severe ischemic mitral regurgitation. , 2015, The Journal of thoracic and cardiovascular surgery.

[18]  Antonio Colombo,et al.  The future of transcatheter mitral valve interventions: competitive or complementary role of repair vs. replacement? , 2015, European heart journal.

[19]  G. Gerosa,et al.  Transapical off-pump mitral valve repair with Neochord implantation: Early clinical results. , 2016, International journal of cardiology.

[20]  Emilia Bagiella,et al.  Two-Year Outcomes of Surgical Treatment of Moderate Ischemic Mitral Regurgitation. , 2016, The New England journal of medicine.

[21]  Francois Dagenais,et al.  Two-Year Outcomes of Surgical Treatment of Severe Ischemic Mitral Regurgitation. , 2016, The New England journal of medicine.