Status Of The MitraClip: Trials (EVEREST II & COAPT) & FDA Ted Feldman, M.D., FSCAI FACC FESC Evanston Hospital SCAI Fall Fellows Course Las Vegas, Nevada December 8 11 th, 2013
Ted Feldman MD, FACC, FESC, FSCAI Disclosure Information The following relationships exist: Grant support: Abbott, BSC, Edwards, WL Gore Consultant: Abbott, BSC, Coherex, Edwards, Intervalve, Diiachi Sankyo-Lilly, WL Gore Off label use of products and investigational devices will be discussed in this presentation
CONCLUSIONS Although percutaneous repair was less effective at reducing mitral regurgitation than conventional surgery, the procedure was associated with superior safety and similar improvements in clinical outcomes.
Kaplan-Meier Freedom from MV Surgery (Device) or Re-operation (Surgery) Intention to Treat 78.2% of Device patients are free from MV surgery at 2 years At Risk: Percutaneous Surgery 5 0 Days 6m 1yr 1.5yr 2yr 3yr 184 138 131 124 109 44 95 77 72 69 69 24
Gary G, Feldman T: The basic technique for the Evalve MitraClip procedure in Feldman T, St. Goar F: Percutaneous mitral leaflet repair. Informa, London, 2012.
Endovascular Valve Edge-to-Edge REpair STudy Subgroup Analyses for the Primary End Point at 12 Months Feldman T et al. N Engl J Med 2011;364:1395-1406
The EVEREST II High Surgical Risk Cohort n=351 Age 76 ± 11 Predicted Surgical Mortality Risk, (%) 18.2±8.4 NYHA Functional Class III or IV 85% Atrial Fibrillation 69% Mitral Regurgitation Grade 3+ 86% Left Ventricular Ejection Fraction (%) 47.5 ± 14.2 Functional MR 70% 30 day Mortality 6.8% Home ±home health care 91.7 % MR Grade I II at 2 years 87% Decrease LV EDV/ESV at 1 year 17.9 / 8.1 ml Event Free Survival 1 year 77.1% ACC 2013
6/4/2004
Hospitalizations for Heart Failure HF Hospitalization Rate Per Patient Year All treated 1.0 0.8 0.6 0.4 0.2 0.0 0.79 1 Year Prior to MitraClip 48% reduction p<0.0001 0.41 N=351 N=338 1 Year Post Discharge
Reduction in HF Hospitalization Rate by MR Reduction All Treated MR Grade 1+ or 2+ MR Grade 3+ or 4+ 54% Reduction Exploratory analysis 1 Year Prior to MitraClip 1 Year Post Discharge 1 Year Prior to MitraClip 1 Year Post Discharge
Implant Rate & Acute Procedural Success in Clinical Series 2010 2012 Author n Patient Status Follow up Implant Rate Acute success (MR 2+) Tamburino 31 Not specified 30 day 100% 97% Franzen 51 High surgical risk Procedural 96% 96% Schillinger 50 High surgical risk 6 12 months 98% 80% Pleger 51 High surgical risk 30day 92% ~82% Rudolph 104 High surgical risk 12 months 92% 82.5% Van den Branden 52 Extreme surgical risk 6 months 96% 79% Ussia 39 High surgical risk 6 months 100% 100% Baldus 486 High surgical risk 6 months 99% 94% Franzen 48 End stage heart failure 6 months 96% 92% Aurrichio 51 CRT non responders 12 months 100% ~80% Tamburino Eur Heart J 2010;31:1382-89. Franzen Eur Heart J 2010;31:1373-81. Schillinger Kardiologe 2011;5:91-97. Pleger AJC 2011;108:1478-82. Rudolph JACC 2011;58:2190-95. Van den Branden JACC Intervention 2012;5:105-11. Ussia Int J Cardiol 2012;155:194-200. Baldus Eur J Heart Fail 2012;14:1050-55. Franzen Eur J Heart Fail 2011;13:569-76. Aurrichio JACC 2011;58:2183-89. Gaemperli Heart 2012;98:126-32.
INDICATIONS FOR MITRAL VALVE OPERATION
Guidelines on the management of valvular heart disease 2012 European Heart Journal (2012) 33, 2474
Clinical Outcomes Assessment of the MitraClip Percutaneous Therapy for High Surgical Risk ~420 patients enrolled at up to 75 US sites Significant FMR 3+ core lab High risk for mitral valve surgery- Local Heart Team Specific valve anatomic criteria Randomize 1:1 MitraClip Control group Standard of care Safety: Composite death, stroke, worsening renal function, LVAD implant, heart transplant at 12 months Effectiveness: Recurrent heart failure hospitalizations Protocol conditionally approved by FDA July 26, 2012
CRT in Patients With Moderate-Severe Functional MR and High Operative Risk Circulation. 2011;124:912-919
Improved Functional Status and Quality of Life in Prohibitive Surgical Risk Patients With Degenerative Mitral Regurgitation Following Transcatheter Mitral Valve Repair with the MitraClip System Lim DS, MD, Reynolds MR, MD, Feldman T, MD, Kar S, MD, Herrmann HC, MD, Wang A, MD, Whitlow PL, MD, Gray WA, MD, Grayburn P, MD, Mack MJ, MD, Glower D, MD:
MitraClip Clip Delivery System Approved October 24, 2013 Indication for Use: The MitraClip Clip Delivery System is indicated for the percutaneous reduction of significant symptomatic mitral regurgitation (MR 3+) due to primary abnormality of the mitral apparatus [degenerative MR] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation.