Antonio Colombo. Centro Cuore Columbus and S. Raffaele Scientific Institute, Milan, Italy. Miracor Symposium. Speaker: 15. Parigi: May 16-19, 2017

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1 Parigi: May 16-19, 2017 Miracor Symposium Speaker: 15 Antonio Colombo Centro Cuore Columbus and S. Raffaele Scientific Institute, Milan, Italy

2 Nothing to disclose

3 PiCSO Impulse System Elective high risk cases in Milan

4 Case: 81y Female Baseline angiogram

5 LMT dis 50-75% LCX os 90% RCA CTO IMos 90% LAD tandem 90% calcification SYNTAXscore 50 Collateral from LCA to RCA Planned to perform LMT-LAD PCI under the support of PICSO system

6 Procedures Antegrade CS visualization 8.5Fr sheath Connecting the catheter to the system CS angio PiCSO impulse catheter

7 Starting the PiCSO system 1st Inflation cycle 2nd Inflation cycle 3rd Inflation cycle = 1 st CS occlusion CS pressure (Tip of the catheter) Adjustment of balloon volume to CS diameter

8 PiCSO system in Progress Intermittent occlusion of the CS (min. 3 sec., max. 30sec.) Duration of occlusion individually calculated for each cycle based on CS pressure Inflation cycle Deflation cycle

9 Baseline NC2.5*20mm NC2.5*20mm Post NC2.5mm EES 2.5*28mm NC2.5mm

10 PiCSO system during and after LAD stenting CSP decreasing CSP increasing LAD ballooning Deflate

11 CSP increased due to increased LAD flow after stenting/ballooning

12 LMT-LAD EES 3.0*23 NC 4.0mm KBT 3.5mm/2.5mm Final angio

13 Final angiogram PMI (-)

14 PiCSO Therapy completed Intervention time Picso time (cumulative balloon inflation time) Picso Quantity Target (In STEMI) Recommended PiCSO Quantity: 800 mmhg Picso therapy should be applied during complete stenting procedure Minimum recommended Intervention Time 20min

15 Clinical case presentation 75-year-old male; family history of CAD, hypertension, dyslipidemia, diabetes, peripheral artery disease, chronic kidney disease (egfr 35 ml/min/1.73 m 2 ) Prior PCI (Cypher) on M1 and RCA in 2004, aortic valve replacement with mechanical prosthesis and CABG (LIMA- LAD) in 2006, atrial fibrillation (warfarin) Dyspnea on exertion (NYHA III) for the past 2 weeks Echo: dilated LV, LVEF 25%, aortic prosthesis functioning well (mean gradient 5 mmhg, no leaks), moderate MR Labs: Hb 10.3, platelets 328, creatinine 172 (his baseline), INR 2.28, hs-tht 338 ECG: atrial fibrillation at 90 bpm, non-specific ST-T changes

16 Critical and calcified distal LM- LAD-Cx stenosis (Medina 1-1-1) Long and severe stenosis in the proximal LAD Patent LIMA-LAD Occluded distal RCA Diseased distal LAD

17 Pressure-controlled intermittent coronary sinus occlusion PICSO is a balloon-tipped catheter that intermittently occludes the coronary sinus, thus increasing coronary sinus pressure. This translates into an increase in (arterial) wedge pressure over ischemic areas of myocardium, thus improving microvascular perfusion. Promising data in anterior-wall STEMI patients treated with ppci PICSO led to infarct size reduction at 4 months (CMR), as compared with matched controls (van de Hoef et al. EuroIntervention 2015;11:37-44). No experience using PICSO to relieve myocardial ischemia during high-risk PCI. PICSO, Miracor Medical Systems

18 Procedural planning Right femoral vein and artery access (9 Fr and 6 Fr, respectively) PICSO Impulse System (Miracor Medical Systems GmbH, Vienna, Austria) before PCI PCI: Rotablator on LM-Cx, high likelihood of a two-stent strategy, final IVUS Remove PICSO at the end of the procedure

19 CSP dynamics confirm increased LAD flow after stenting PICSO supports myocardial perfusion and wash-out during procedure Rotational atherectomy PICSO Impulse catheter (8 Fr) Increased coronary sinus pressure (CSP) Increased CSP during/after Rotablator Steerable OSCOR guide sheath (8.5 Fr) Inflated PICSO balloon

20 Rotablator on LM-Cx Culotte stenting on LM-LAD-Cx 1.50 mm burr at 180,000 rpm Cx: Xience Pro x 3.5x28 mm LAD: Xience Pro x 3.5x23 mm Kissing balloon, POT (4.5x6 mm NC balloon) Residual disease distal to LAD stent Overlapping Xience Alpine 3.0x15 mm in the LAD

21 LM MLA mm 2, ø 4.20x4.99 mm Final result LM bifurcation Optimal apposition, no protruding struts PICSO removed after PCI. Peak hs-tnt 144 ng/l. Hospital stay uneventful. LVEF before discharge increased to 35%. Patient asymptomatic and hemodinamically stable throughout the procedure. PICSO quantity was 816 mmhg (values >800 mmhg correlate with myocardial salvage).

22 Severe Acute LV Dysfunction not recovering despite ECMO

23 CASE 2 Male, 32 yo CV risk factors: No major CV risk factors Aortic valve disease: Bicuspid aortic valve Severe aortic regurgitation; normal ascending aorta Dilated left ventricle; normal systolic function (LVEF 60%)

24 CLINICAL COURSE The patient underwent aortic valve repair with free margin plication and subvalvular annuloplasty Five hours after surgery ventricular fibrillation cardiogenic shock severe LV dysfunction Peripheral venous-arterial extracorporeal membrane oxygenation (VA-ECMO) and intra-aortic balloon pump (IABP) were implanted The patient was carried in the cath lab to undergo coronary angiography

25 ECHO Severe LV dysfunction

26 CORONARY ANGIO

27 CLINICAL COURSE 1st PO day: Impella placement due to poor LV unload IABP removal 1st to 15th PO day: Full mechanical support with VA-ECMO and Impella No LV function recovery 15th PO day: repeated coronary angiography due to persistent severe LV dysfunction

28 CORONARY ANGIO

29 PICSO

30 CLINCAL COURSE The day after PICSO placement (17th PO day): Complete recovery of normal LV function 17th to 20th PO day: Prolonged pressure-controlled intermittent coronary sinus occlusion Total treatment time: 4 days, 9 hours PICSO quantity*: mmhg * PICSO quantity = balloon inflation hold time*(mean systolic coronary sinus pressure plateau - mean coronary sinus pressure during deflation)*(mean systolic coronary sinus pressure plateau - mean diastolic coronary sinus pressure plateau) 20th PO day: Weaning from VA ECMO completed Removal of VA ECMO and Impella Placement of venous-venous ECMO because of persistent respiratory failure

31 Echo after 12-hrs of PICSO Severe LV Dysfunction Complete recovery of LV function

32 Conclusions I We successfully treated high risk case under myocardial protection with PiCSO system During the procedure, the patient was stable without any symptom and hemodynamic change PiCSO system might be one option as a support for elective high risk PCI

33 Conclusions II Standard PICSO treatment: To reduce the extent of myocardial necrosis in STEMI patients Usually minutes (max 60 minutes) Novel applications: 1. Microcirculatory support for High-Risk PCI 2. Prolonged PICSO therapy To treat refractory LV dysfunction and ongoing ischemia Efficacy probably related to redistribution of venous blood and improvement in microvascular perfusion