Percutaneous ventricular partitioning

Emerging interventional technologies for heart failure management Percutaneous ventricular partitioning Hüseyin Ince MD, PhD University of Rostock Germany

Potential conflicts of interest Speaker s name: Hüseyin Ince I do not have any potential conflict of interest

Overview: The Problem - Remodeling After MI Leads to Heart Failure Myocardial Infarction Cell Death infarct expansion LV dilation LV remodeling HF Initial Infarct Hours to days Months to years

PVRT (Percutaneous Ventricular Restoration Therapy) A new structural heart category for percutanous medical devices that address ventricular remodeling in heart failure patients PARACHUTE

Treatment of post LAD MI Structural Damage with PARACHUTE Left Ventricular Implant Dilated LV Dysfunctional Apical Region Reduces diastolic & systolic volumes Restores conical apical shape Provides synchronized contraction PARACHUTE Excludes Akinetic/Dyskinetic Apex Partitions the Left Ventricle

PARACHUTE Implant Nitinol struts with anchors eptfe membrane Radiopaque polymer foot 65, 75, 85 and 95 mm nominal diameters Implanted oversized position

PARACHUTE Delivery System Delivery Guide 14 and 16 Fr. guides Multiple shapes Variable stiffness Kink resistant Dilator with 6 Fr lumen Delivery Catheter Shaped to match guides Flexible torque drive Threaded implant attachment Lockable handle Large balloon > 30mm

Target Patient Population NYHA Class II-IV EF >15% and < 40% Post LAD MI Dilated apical region with akinetic or dyskinetic wall motion abnormality Warfarin and ASA 1 yr post implant

Pre-Parachute Implantation (TTE)

Pre-Parachute Implantation (CT)

Pre-Parachute Implantation (Cardiac CT)

Parachute Implantation

Post-Parachute Implantation (Cardiac CT)

Improvement in NYHA Class all p<0.001 baseline vs. time points Nicolic S TCT 2011

12 Month Event Rate: PARACHUTE Patients PARACHUTE non-randomized feasibility trials All cause mortality and hospitalization for HF Events/pts Intent to Treat 17.9% (2D, 5 WHF)/39 As Treated 16.1% (1D, 4WHF)/31 Event Rate in Comparable Study Population is ~40% Nicolic S TCT 2011

Histology The luminal surface is completely endothelialized by smooth, glistening tan-white tissue. The foot is centered at the LV apex. Foot is well apposed to the endocardial surface at the LV apex, with good healing response characterized by endothelialization on both sides of the eptfe membrane. Dr. R. Virmani (CV Path)

Patient Demographic and Baseline Table1. Baseline clinical characteristics of patients with IHF, who were selected by according to echocardiographic criteria and 3D Cardiac CT examination to VPD implantation IHF patients (n=8) Age 62 10 m/f 5/3 Cardiovascular Risk Factors (%) Hypertension 60 Hyperlipidemia 60 Smoking 80 Diabetes 20 Positive family history of CAD 20 Transmural myocardial infarction, months before VPD Implantation 28 13 No. of diseased vessels 1.9 0.5 Infarct-related vessel (LAD/LCX/RCA) 8/0/0 PTCA/Stent at the time of AMI 8/8 Medication (%) Aspirin 100 Clopidogrel 20 ACE inhibitor or AT II blocker 100 Beta-blocker 100 Aldosterone Antagonist 100 Statin 100

LVEF p<0.05 28±6 33±6

LVEDV and LVESV p<0.05 p<0.05 220±78 190±72 154±52 132±56

NYHA Class and NT-ProBNP p<0.05 p<0.05 2.8±0.7 1.6±0.5 850±398 702±202

6 min walk test p<0.05 305±68 495±82

Quality of Life Score p<0.05 29±13 15±10

Clinical Program Overview Trial Status Geography N PARACHUTE cohort A (The PARACHUTE Trial) PARACHUTE US Feasibility Trial Enrollment completed in 2007 Enrollment completed in 2009 Europe 19 US primarily 20 PARACHUTE cohort B (The PARACHUTE Trial) Active enrollment Europe up to 80 PARACHUTE III Post Market Study PARACHUTE IV IDE Study Enrollment to begin Feb 2012 Enrollment to begin Oct 2012 Europe 100 United States 478

Conclusions Percutaneous Ventricular Restoration Therapy (PVRT) to date has shown to be safe, prevents dilation and improves clinical status in HF patients with LV structural damage post LAD infarct

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