Percutaneous Treatment of Mitral Regurgitation Why do we

Percutaneous Treatment of Mitral Regurgitation: Why do we need it at the VA? Santiago Garcia, MD Associate Professor of Medicine, University of Minnesota Director, Structural Heart Program MVAHCS Garci 205@umn. edu

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Prevalence of Valvular Heart Disease by Age Nkomo et al. The Lancet (368) Sept 16, 2016

The mitral valve

Primary MR: The problem is in the leaflets

Secondary MR: The problem is in the MV complex (annulus, PM, chordae, LV)

Primary (degenerative or DMR) vs. Secondary (functional or FMR) Mitral Regurgitation • • • Severe Primary MR Central jet > 40% of LA or holosystolic eccentric jet Vena contracta ≥ 0. 7 cm Regurgitant volume > 60 ml Regurgitant fraction ≥ 50% ERO ≥ 0. 40 cm 2 Angiographic grade 3 -4+ Severe Secondary MR (ACC 2014) • ERO > 0. 2 cm 2 • Regurgitant volume > 30 cc • Regurgitant fraction > 50% Severe Secondary MR (ACC 2017) • ERO ≥ 0. 40 cm 2 • Regurgitant volume > 60 ml JACC/AHA Valvular Heart Disease Guidelines. JACC (63). N 22. June 10 th 2014. Nishimura et al. J Am Coll Cardiol 2017; 70: 252– 89.

Stages of MR Nishimura et al. J Am Coll Cardiol 2017; 70: 252– 89.

Indications for Surgery

Indications for Intervention: Primary MR

Indications for Intervention: Secondary MR No Class I Indications

Standard of care: MV Repair

Double Lumen Valve: Alfieri’s Procedure or “Surgical Clip”

Transcatheter Therapies: Why? • Surgery is associated with mortality rates of 1 -5% • Morbidity rates 10%-20% (stroke, prolonged ventilation, renal failure, bleeding) • Mortality in octogenarians as high as 17% with > 20% risk of hospitalization within 30 days • 30% recurrence of 3 -4+ MR in patients with ischemic MR treated with surgery • Up to 50% of patients that have an indication for MVR do not undergo surgery

Transcatheter Therapies for MR (2018) Anatomic Target Device Name Manufacturer Status Leaflet/Chordal Mitra. Clip Abbott Vascular CE Mark/FDA approved Neochord (MN) CE Mark PASCAL Edwards Phase I, FIM Carrillon Cardiac Dimensions CE Mark Cardioband Valtech Cardio CE Mark GDS Accucinch Guided delivery systems Phase I Hybrid surgical Annuloplasty ring SJM (MN) CE Mark LV remodeling Basal Annuloplasty (BACE) Mardil Medical (MN) Phase I Replacement Tiara Neovasc Phase I, FIM Intrepid Medtronic (MN) Phase I, FIM Cardia Q Edwards Phase I, FIM Tendyne Abbott Vascular Phase I, FIM Annuloplasty

The Clinical Evidence: EVEREST II Trial

EVEREST II 1 -Year Results “percutaneous repair less effective… but associated with superior safety” Device Control (Surgery) Death 6% 6% Surgery for MV dysfunction 20% 2% Grade 3+ or 4+ MR 21% 20% Primary End-Point (freedom from death, MV surgery or MR grade 3 -4) MACE 55% 73% 15% 48% Feldman et al. NEJM 2011; 364: 1395 -406

FDA approved indications and ACC/AHA Guidelines: Mitra. Clip

Commercial Experience in the US Average Age=83, STS=8 Sorajja et al. JACC 2016 (67): 1129 -40

Residual MR After Mitra. Clip 93 % with Residual MR Grade 1 or 2. 37% required > 1 Clip

Predictors of Success after Mitra. Clip : A 2 -P 2 Pathology and Case Volume

Short-Term (30 -day) Outcomes Sorajja et al. JACC 2016 (67): 1129 -40

Sorajja et al. JACC 2016 (67): 1129 -40

Sorajja et al. JACC 2016 (67): 1129 -40

Sorajja et al. JACC 2016 (67): 1129 -40

Sorajja et al. JACC 2016 (67): 1129 -40

Ongoing Mitra. Clip Trials • COAPT: Clinical Outcomes Assessment of the Mitra. Clip Percutaneous Therapy for Extremely High-Surgical Risk Patients (NCT: 01626079)

Worldwide Mitra. Clip Registries: Most Patients Treated in Europe have FMR

FDA approved indications and ACC/AHA Guidelines: Mitra. Clip (2017)

Percutaneous Treatment of Mitral Regurgitation Santiago Garcia, MD Associate Professor of Medicine, University of Minnesota Director, Structural Heart Program MVAHCS Garci 205@umn. edu