Innovations in Mitral Valve Repair Update on Latest

Innovations in Mitral Valve Repair: Update on Latest Trials Chandan Devireddy, MD, MBA, FSCAI Associate Professor, Emory University Director, Cardiac Catheterization Laboratory, Emory University Hospital Midtown May 15, 2020

Disclosures Scientific Advisory Board: Medtronic Re. Cor Medical Consultant: Shockwave Medical

Learning Objectives • Instead of delivering a barrage of start-up device images in their infancy • Will focus on performance data of the newest iterations of the two mitral repair systems most likely to commercially be seen in near future: • Mitraclip • Pascal

Mitra. Clip™ Evolution -NTR/XTR

EXPAND Study: Contemporary Real World Outcomes with Mitraclip NTR/XTR Lim S. EXPAND Investigators. ACC. 20

EXPAND: Study Flow

EXPAND: Baseline Characteristics

EXPAND: Corelab Adjudicated Baseline Echo Parameters *These patients assessed as baseline MR Severity 3+/4+ by the sites.

EXPAND Procedural Outcomes vs Previous Trials

Mitraclip type used in subjects with Primary MR

EXPAND: 30 day Major Adverse Events

Device Related Leaflet Adverse Events

Corelab Adjudicated MR Severity: By Baseline MR

EXPAND: Qo. L and Functional Capacity

XTR vs NTR use in varying Mitral anatomic characteristics

30 d MR reduction ≥ 2 grades by XTR/NTR use

EXPAND: Conclusions • • This study represents the first contemporary report of core lab adjudicated 30 day clinical outcomes in patients with primary MR treated with next generation NTR and XTR Mitra. Clips • MR ≤ 1+ was achieved more often with Mitra. Clip™ NTR and XTR than previously observed in EVEREST II trials • Mitra. Clip™ XTR was associated with greater MR reduction compared to NTR, in specific types of anatomic complexity • Discrepancies persist in how severe MR is being defined at the community level •

Mitraclip EXPAND G 4 Study: Stay Tuned… G 4 NTW G 4 XTW

PASCAL Mitral Repair System

CLASP: Key study criteria

CLASP: Study Endpoints

CLASP: Study Flow Kar S. and CLASP Investigators. TCT 2019

CLASP: Baseline Demographics Kar S. and CLASP Investigators. TCT 2019

CLASP: Procedural Characteristics Kar S. and CLASP Investigators. TCT 2019

CLASP: Composite MAE at 30 days Kar S. and CLASP Investigators. TCT 2019

CLASP: Qo. L and Functional Capacity Kar S. and CLASP Investigators. TCT 2019

Stay tuned…

Conclusions • Contemporary studies of transcatheter mitral leaflet repair demonstrate continued evolution of operator and technology towards higher efficiency, success, and safety • Continued research required to better understand: • Which device? • In which patient? • In what anatomy?