GDMT for percutaneous mitral valve repair

Transcription

1 GDMT for percutaneous mitral valve repair Ted Feldman, M.D., MSCAI FACC FESC Evanston Hospital The 11th Annual Innovations & Trends in Cardiovascular Care New Brunswick, NJ October 18 th 2014

2 Ted Feldman MD, MSCAI FACC FESC Disclosure Information The following relationships exist: Grant support: Abbott, BSC, Edwards, WL Gore Consultant: Abbott, BSC, Coherex, Edwards, Intervalve, JenaValve, Diiachi Sankyo-Lilly, WL Gore Off label use of products and investigational devices will be discussed in this presentation

3 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:

4 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.

5 Clinical Outcomes Assessment of the MitraClip Percutaneous Therapy for High Surgical Risk ~430 patients enrolled at up to 75 US sites Significant FMR 3+ core lab; EF<50%; CHF hospitalization or BNP>300 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

6 COAPT Inclusion Symptomatic functional MR ( 3+) due to cardiomyopathy of either ischemic or nonischemic Functional MR requires the presence of global or regional left ventricular wall motion abnormalities, which are believed to be the primary cause of the MR LVEF 20% and 50% Version 5.1 November 11, 2013

7 COAPT Inclusion Qualifying TTE must be obtained after the subject has been stabilized on optimal therapy and at least 30 days after: any change in GDMT revascularization and/or implant of CRT device or reprogramming of an implanted CRT or CRT-D that results in increased biventricular pacing (from <92% to 92%) In the judgment of the HF specialist investigator at the site, the subject has been adequately treated per applicable standards Version 5.1 November 11, 2013

8 COAPT Inclusion at least one hospitalization for heart failure in the 12 months prior to subject registration and/or a corrected BNP 300 pg/ml or corrected NT-proBNP 1500 pg/ml measured within 90 days New York Heart Association (NYHA) Functional Class II, III or ambulatory IV Heart Team and the Central Eligibility Committee concur that surgery will not be offered Version 5.1 November 11, 2013

9 COAPT Exclusion Physical evidence of right-sided CHF with echo evidence of moderate or severe RV dysfunction Implant of any Cardiac Resynchronization Therapy (CRT) or Cardiac Resynchronization Therapy with cardioverter-defibrillator (CRT- D) within the last 30 days prior to subject registration Mitral valve orifice area < 4.0 cm2 assessed by site based on TTE Version 5.1 November 11, 2013

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12 2013 ACCF/AHA Guideline for the Management of Heart Failure GDMT J Am Coll Cardiol. 2013;62(16):e147-e239. doi: /j.jacc

13 2013 ACCF/AHA Guideline for the Management of Heart Failure CRT J Am Coll Cardiol. 2013;62(16):e147-e239. doi: /j.jacc

14 2013 ACCF/AHA Guideline for the Management of Heart Failure Therapy by Stage J Am Coll Cardiol. 2013;62(16):e147-e239. doi: /j.jacc

15 2013 ACCF/AHA Guideline for the Management of Heart Failure Pharmacological management of patients with newly discovered AF J Am Coll Cardiol. 2013;62(16):e147-e239. doi: /j.jacc

16 Guideline-Directed Medical Therapy (GDMT)

17 Managing GDMT Site HF Specialist to confirm that subjects are on adequate guideline-directed medical therapy (GDMT) not only at registration but also throughout the trial Reason(s) for subject not being on a guideline directed drug or dosage must be thoroughly documented using GDMT source worksheet and electronic Case Report Form

18 GDMT Source Worksheet

19 GDMT Source Worksheet (cont.)

20 GDMT Source Worksheet (cont.)

21 GDMT Source Worksheet (cont.)

22 GDMT Source Worksheet (cont.)

23 GDMT Source Worksheet (cont.)

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27 If you can't explain it simply, you don't understand it well enough.