Functional Mitral Regurgitation and Congestive Heart Failure: Medical Therapy, Surgery, or Transcatheter Mitral Valve Therapy? Michael Mack, M.D. Baylor Scott & White Healthcare System Dallas, TX Conflict of Interest Disclosure • Co- PI of COAPT Trial -MitraClip - Abbott Vascular is trial sponsor • Uncompensated Mitral Regurgitation Functional Degenerative (Secondary) (Primary) Type IIIb Type II Mitral Regurgitation Functional Degenerative (Secondary) (Primary) Ischemic Non-ischemic FMR Disease of the Left Ventricle NOT the Mitral Valve Normal LV Dilated LV tethering one or both leaflets Mechanisms of Ischemic Mitral Regurgitation Papillary muscle traction Increased tethering Decreased closing force Bulging MR Annular dilatation Levine and Schwammenthal. Circulation 2005 FMR A Vicious Annular-Ventricular dilatation Cycle Volume overload FMR IMR Frequency of MR in a CHF population=90% Heart failure clinic, EF≤35%, Class III-IV Mod-Sev 12.5 Retrospective Severe 4.3 0-Trace 10.4 1996-2001 Echo reports Quantitative MR Mild 31.9 Moderate 21.9 Mild-Mod 11.8 Patel JB- J Cardiac Failure 10:285, 2004 N = 558 Hospital-Free Survival (%) Ischemic or Nonischemic Cardiomyopathy 100 100 EF 34% LVSD 51mm 80 80 40 40 EF 29% LVSD 57mm 20 20 00 No FMR EF 33% LVSD 53mm 60 60 1 1 2 3 Mild-Mod FMR 24% p<0.0001 0 51% Severe FMR 2 4 5 3 4 6 7 8 Time (years) 5 11% 6 7 Rossi et al. Heart 2011;97:1675-1680 FMR: …a marker of a sicker LV - and/or …a target for therapy? Therapies that produce beneficial reverse remodeling also reduce severity of functional MR FMR Goals of Treatment 1. Slow or reverse LV remodeling 2. Improve symptoms/functional class 3. Decrease hospitalizations for CHF 4. Increase time to transplant or VAD (slow progression to advanced HF) 5. Improve survival Functional Mitral Regurgitation and CHF Medical Therapy Surgery MitraClip Medical Treatment of FMR Current Options • Pharmacologic Therapy o RAAS inhibition (ACE-I, ARB) o Beta-Blockers o Aldosterone Antagonists • Cardiac Resynchronization Therapy (CRT) Undersized Annuloplasty Undersized Surgical Annuloplasty How to treat this 69-year old male ? • Mitral regurgitation III-IV, EF 35 %, AFib, NYHA class III-IV • Medical history: o o o o s/p anterior myocardial infarction 1988 s/p posterior myocardial infarction in 1991 2-CABG 1993 biventricular ICD 2005 • Concomitant diseases: o o o o COPD renal insufficiency III° hyperlipidaemia arterial hypertension Echocardiography EF 29 %, LVEDD: 61 mm MV: annulus 47 mm restrictive AML, MI III°, Type IIIB LA: 47 mm Postoperative echo result No residual MI Orifice area: 3.3 cm2 Mean gradient: 2 mmHg How are Patients with Isolated FMR Treated? Duke Databank: 1,538 pts with echocardiographic 3+ - 4+ FMR and LVEF ≥20% between 2000 and 2010 not undergoing CABG Management: Conservative management 100% 11.4% 5.9% All pts N=1538 Isolated MV surgery 8.4% 11.8% 18.4% 20%-30% 30%-40% 40%-50% 50%-60% N=440 N=298 N=313 N=479 75% 50% 25% 0% 8 other pts had LVEF >60%; none underwent MV surgery LVEF c/o Mitch Krucoff Bolling Annuloplasty • 419 patients with No annuloplasty – LVEF <30% – mod-severe MR – considered surgical candidates • Non-randomized (adjusted) comparison of – 126 MV annuloplasty and MV annuloplasty – 293 no surgery • No difference in adjusted mortality with or without CAD Wu and Bolling et al, J Am Coll Cardiol 2005;45:381-7 Durability of Ischemic Mitral Valve Repair • 78 patients with IMR treated with Mitral Valve Repair • Mean - 28 months: • Echo- 94% o Recurrent MR (2+) in 37% o Severe MR (3 to 4+) in 20% Serri et al. JTCVS 131:565-573, 2006 Chronic Severe Secondary Mitral Regurgitation: Intervention Recommendations MV surgery is reasonable for patients with chronic severe secondary MR (stages C and D) who are undergoing CABG or AVR MV surgery may be considered for severely symptomatic patients (NYHA class III-IV) with chronic severe secondary MR (stage D) MV repair may be considered for patients with chronic moderate secondary MR (stage B) who are undergoing other cardiac surgery COR LOE IIa C IIb B IIb C What Causes Recurrent IMR After MV Repair? Kuwahara et al, Circulation, 2006;114:I529-I534 Mitral Valve Surgery Repair vs. Replacement November 18, 2013, at NEJM.org. N=251 35.00% 32.60% 30.00% 25.00% 20.00% P<0.001). Repair 15.00% Replacement 10.00% 5.00% 2.30% 0.00% Recurrent MR at 12 Months When Should We Be Performing MV Replacement for IMR? Ruptured papillary muscle (acute IMR) • Patients in cardiogenic shock • Severe apical tenting (>11mm) •PLA > 45 degrees • During second CPB run • Complex MR leaks? • Surgeons who do not do many repairs? Valve of choice – bioprosthesis • Post-Infarct Bend MR Post-Infarct Chord Cut Intermediate chord cut No MR Improved coaptation Messas et al Circulation 2001 Chordae Tendinae Anatomy Anterior leaflet “strut” chord Transcatheter Mitral Valve Repair MitraClip COAPT: Trial design ~420 patients enrolled at up to 75 US sites Significant FMR (≥3+ by core lab) Not appropriate for mitral valve surgery (local heart team) Specific anatomical criteria Randomize 1:1 MitraClip N=210 April 2014 Control group Screened 328 Standard of care Randomized 65 N=210 Clinical and TTE follow-up: 1, 6, 12, 18, 24, 36, 48, 60 months PIs: Michael Mack and Gregg W. Stone Sponsor: Abbott Vascular COAPT Trial Patient • • • • • • • • • • 72 year old male Hypertension Type II DM Fe deficiency anemia –IV Fe therapy Previous CABG Previous PCI I COPD- remote smoker NYHA Class IV CHF Ascites – 2 paracenteses in 2 months STS PROM- 18% Medications • • • • • • • • • Carvedilol 6.25mg BID Captopril 12.5mg TID Trandolapril 2mg daily Metolazone 5mg daily Furosemide 40 mg BID Sildenafil Atorvastatin Ventolin Spiriva Echo Second Clip TTE 30 Days Post Procedure Chronic Primary Mitral Regurgitation: Intervention (cont.) Recommendations Percutaneous MV repair may be considered for severely symptomatic patients (NYHA class IIIIV) with chronic severe primary MR (stage D) who have a reasonable life expectancy, but a prohibitive surgical risk because of severe comorbidities MVR should not be performed for the treatment of isolated severe primary MR limited to less than one half of the posterior leaflet unless MV repair has been attempted and was unsuccessful COR LOE IIb B III: Harm B Adjustable Annuloplasty Surgically or Delivered via a Catheter Surgery Cardioband 54 Valtech Cardioband 55 FIM, Feb 2013, San Raffaele Hospital, Milano, Italy High risk IMR patient with previous CABG, Severe type IIIb MR 57 Sixth Anchor Implantation Posterior Band Deployed Trigone to Trigone Cardioband implant Cardioband delivery system 61 Current Study – Preliminary Results Core Lab 18 patients enrolled Successful implantations in all 18 patients Septo-lateral (A-P) diameter reduced in all patients. MR reduced in all patients One case of recurrent MR due to partial device dehiscence resulted in operation 30 days post implantation. The patient died 60 days post procedure, unrelated to the device. 17 patients discharged, with no major adverse safety events. Confidential Mitral Regurgitation (TTE) SEVERE ( 3 – 4+ MR) MODERATE ( 2+ MR) MILD (1+MR) No. of patients 4 8 7 7 1 1 BASELINE (N=11) DISCHARGE (N=10) Confidential 2 5 1 1-MONTH 6-MONTH FOLLOWUP (N=10) FOLLOWUP (N=5) 35.00% 32.60% 30.00% 25.00% 20.00% P<0.001 Repair 15.00% Replacement 10.00% 5.00% 2.30% 0.00% Recurrent MR at 12 Months TMVR CardiaQ Tendyne Valtech Neovasc Tiara Edwards CardiAQ™ TMVI System For illustration only – the devices depicted are not an accurate reflection of the CardiAQ TMVI technology CardiAQ TMVI Animal Model Tendyne Transapical Mitral Valve • Fully Retrievable and repositionable • NiTi Stent with porcine pericardium • Left ventricular apical tether • Simple, controlled deployment • Requires no rapid pacing or CPB support FIM Tendyne Baseline Post TMVR Tendyne Valve - Human Implant Tiara Cardiovalve Sealing Test Edwards First-in-Human Mitral THV • Designed to minimize PV leak • Self-expanding • Unique anchoring • GLX bovine pericardial tissue • Large profile requires transapical delivery • 3 FIM patients done by Vinnie Bapat and Martyn Thomas in London February , 2014 12/9/13 84 85 FMR Summary • Secondary MR is a disease of the ventricle NOT of the valve • Correcting the MR has never been shown to change the course of the disease • COAPT trial may help answer that question • CTSN trial has helped define patients in whom replacement may be preferable • 2014 will see the first-in-man and early feasibility with a number of devices for TMVR via a transapical approach
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