PiCSO to Improve Myocardial Salvage and Reduce Infarct Size in STEMI: Emerging Data

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1 PiCSO to Improve Myocardial Salvage and Reduce Infarct Size in STEMI: Emerging Data Azfar G. Zaman, MD Freeman Hospital, Newcastle upon Tyne, UK

2 Disclosure Statement of Financial Interest Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship Grant/Research Support Consulting Fees/Honoraria Company Miracor Medical Systems Miracor Medical Systems

3 Disclosure Statement of Financial Interest I, Azfar G. Zaman DO NOT have a financial interest/arrangement or affiliation with one or more organizations that could be perceived as a real or apparent conflict of interest in the context of the subject of this presentation.

4 Acknowledgement Co-investigators Mohaned Egred - Freeman Hospital, Newcastle upon Tyne, UK Alan Bagnall - Freeman Hospital, Newcastle upon Tyne, UK Ioakim Spyridopoulos - Freeman Hospital, Newcastle upon Tyne, UK Ian Purcell - Freeman Hospital, Newcastle upon Tyne, UK Rajiv Das - Freeman Hospital, Newcastle upon Tyne, UK Nick Palmer - Liverpool Heart and Chest Hospital, Liverpool, UK Ever Grech - Sheffield Teaching Hospital, Sheffield, UK Ajay Jain - St. Bartholomew s Hospital, London, UK Gregg W. Stone - Columbia University; CRF, New York, NY, USA Robin Nijveldt - VU University Medical Center, Amsterdam, NL Roger Kessels - Miracor Medical Systems GmbH, Vienna, Austria

5 Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) PiCSO increases average coronary sinus pressure and improves coronary perfusion in the ischemic zone The mechanism of action is reduction of reperfusion injury through improved microvascular perfusion PiCSO Impulse Catheter in Coronary Sinus

6 PiCSO during primary PCI PiCSO is applied after flow restoration and during stenting Balloon catheter is introduced via the femoral vein and placed in the coronary sinus Therapy runs automatically, intermittently inflating and deflating the balloon based on patient s individual anatomy and hemodynamic pressures Stenting Flow Re- PCI storation PiCSO Median CS cannulation time: 12 minutess* Median PiCSO therapy duration: 40 minutes* * Interim study analysis

7 PiCSO during primary PCI Inflation Cycle CS Pressure Deflation Cycle

8 PiCSO in a controlled STEMI Study DESIGN: Prospective, parallel controlled, multi-center clinical evaluation of the PiCSO Impulse System in STEMI patients 70 STEMI patients enrolled between Jan and Sept in 4 clinical sites in the UK (ongoing) 7 NSTEMI patients as training cases Patients allocated to PCI + PiCSO or PCI only depending on availability of PiCSO-trained physicians OBJECTIVE: To evaluate the effect of PiCSO on infarct size when applied during ppci in STEMI patients PRINCIPAL INVESTIGATOR Azfar G. Zaman, MD Freeman Hospital, Newcastle upon Tyne, UK Treatment PCI + PiCSO (n=29) 5-day follow-up cmri MVO, Cardiac Function, Infarct Size 4-month follow-up cmri Cardiac Function, Infarct Size Control PCI (n=34) 5-day follow-up cmri MVO, Cardiac Function, Infarct Size 4-month follow-up cmri Cardiac Function, Infarct Size Interim analysis; status Aug. 31, 2016

9 PiCSO in a controlled STEMI Study Enrollment NSTEMI (training) STEMI Control* STEMI PiCSO LHCH, Liverpool, UK Sheffield Teaching Hospital, Sheffield, UK St. Bartholomew s Hospital, London, UK The Freeman Hospital, Newcastle, UK Total Interim analysis; status Aug. 31, 2016 * Consecutive parallel control

10 PiCSO in a controlled STEMI Study Baseline characteristics STEMI Control* STEMI PiCSO P- value Male 32/34 19/ Age 54.18±9.6* 59.41±11.70* NS Height (cm) ±7.73* ±11.07* Weight (kg) 87.20±17.47* 81.6±18.18* NS Pre PCI TIMI flow % 69.0% Post PCI TIMI flow % 100% NS Total ischemic Time 2:30 [1:41-3:59]** 3:17 [1:47-5:24]** NS * average ± SD, ** Median [Q1-Q3] Normal distribution then Independent samples T-test, Interim analysis; status Aug. 31, 2016 if not normal distributed Independent Samples Mann-Whitney Test

11 Myocardial Salvage Reduced infarct size and incidence of MVO MVO (% of patients) 5 days post MI p = Infarct Size (% LV) 5 days post MI p = Control PiCSO Control PiCSO n=19 n=16 n=19 n=16 After multivariate analysis to adjust for differences in baseline characteristics, PiCSO was associated with a predicted reduction in absolute IS by percent points (95% CI (-17.19; -3.44), p=0.005) compared to controls Interim analysis; status Aug. 31, 2016

12 Cardiac Function Improved LVEF, LVEDV, LVESV 100 LVEF (%) 5 days post MI 140 LVEDV (ml/m 2 ) 5 days post MI 140 LVESV (ml/m 2 ) 5 days post MI 80 p = p = p = Control PiCSO Control PiCSO Control PiCSO n=21 n=20 n=21 n=20 n=21 n=20 Interim analysis; status Aug. 31, 2016

13 Conclusions This ongoing study shows that after anterior STEMI, adjunctive PiCSO therapy during ppci is safe, feasible and results in: Reduced incidence of MVO Significantly smaller infarct size Significantly reduced end-diastolic volume Significantly improved left ventricular function 4-month follow-up data are currently being analysed and trending in same direction as 5-day data Next steps: Complete enrollment (n=90) Planning for RCT Interim analysis; status Aug. 31, 2016

14 PiCSO in a controlled STEMI Study Recruiting Centers Freeman Hospital, Newcastle upon Tyne, UK Azfar Zaman Mohaned Egred Alan Bagnall Ioakim Spyridopoulos Ian Purcell Rajiv Das Liverpool Heart and Chest Hospital, Liverpool, UK Nick Palmer Sheffield Teaching Hospital, Sheffield, UK Ever Grech St. Bartholomew s Hospital, London, UK Ajay Jain