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Support Devices for Acute CHF Destination LVADs to exclude Transplant Expectations, Indications, Benefits ,Risks Donna Mancini, MD Mt Sinai School of Medicine Conflict of Interest • None Refractory cardiogenic Shock • 1. Use of temporary percutaneous devices in AHF/cardiogenic shock • 2. Durable devices for Destination therapy Cardiogenic Shock Definition (SHOCK Trial) • Hypotension systolic BP < 90 mm Hg for > 30 min or mean BP 30 mm Hg lower than baseline • Need for pharmacologic or IABP support to maintain SBP > 90 • End organ hypoperfusion • • • • • Cool extremities Urine output < 30 cc/hr Altered mental status Lactate > 2 mmol/l Pulmonary congestion • Hemodynamic criteria • CI < 2.2 l/min/m2 and PCW >15 mm Hg Etiology of Cardiogenic Shock • Acute Myocardial Infarction • • • • Large infarct Moderate or small infarct w pre existing LV dysfn Mechanical complication of MI- acute MR, VSD, LV rupture RV infarct • End Stage Cardiomyopathy • Myocarditis • Valvular Heart Disease • Stress induced cadiomyopathy • Cardiac Tamponade Cardiogenic Shock • AMI occurs in 1 million patients in US and 8 million patients annually worldwide • Cardiogenic Shock occurs in 4-12% of AMI patients • 1 yr Mortality rate is about 65% • IABP-SHOCK II trial failed to show 30 day survival benefit in AMI patients w cardiogenic shock supported by IABP • Shift now is to examine use of other percutaneous devices in these patients The downward spiral of refractory cardiogenic shock SIRS Shock Trial Hochman JAMA 2001;285:190 SHOCK II Trial 2012 Thiele NEJM 2012;367:1287 Non Selective NOS inhibitor Cardiogenic Shock IABP ECMO LV to Aorta LA-Aorta Short Term Mechanical Circulatory Support Devices V-A IABP ECMO TandemHeart Impella Afterload Reduced Increased Increased Neutral LV stroke volume Slight increase Reduced Reduced Reduced Coronary perfusion Slight increase Unknown Unknown Unknown LV pre-load Slightly reduced Reduced Reduced Slightly reduced PCW pressure Slightly reduced Reduced Reduced Slightly reduced Peripheral tissue perfusion No significant increase Improved Improved Improved VA ECMO Elastase EDV to ESP EDP and arterial elastase as ECMO flow TPR ECMO + IABP Ecpella J Am Coll Cardiol. 2015;66(23):2663-2674. KVAD = ECMO+ mini LVAD Koji Takeda Md, Phd Axillary outflow Oxygenator Pulmonary unloading Centrimag pump Femoral v. drainage RV unloading LV apical cannula through mini-thoracotomy LV unloading Tandem Heart LA to Ao J Am Coll Cardiol. 2015;66(23):2663-2674. . Effect of LV to arterial MCS Impella; durable VADs J Am Coll Cardiol. 2015;66(23):2663-2674. Randomized trials of Percutaneous MCS vs IABP in AMI Tandem Heart n=41 Tandem Heart n=33 Impella 2.5 n=26 3 trials totaling 100 patients Reyentovich, A. et al. (2016) Nat. Rev. Cardiol. Randomized trials of Percutaneous MCS vs IABP in AMI Reyentovich, A. et al. (2016) Nat. Rev. Cardiol. Guideline Recommendations of Short Term Mechanical Assist Devices in Cardiogenic shock ACC/AHA/SCAI ESC/EACTS IABP Class IIA Hemodynamic instability after AMI IIb Hemodynamic instability after AMI ECMO none none none ECMO implantation should be considered for temporary support in patients with acute heart failure with potential for functional recovery following revascularization. Tandem Heart IIB Same as IABP IIb Routine use of percutaneous centrifugal pumps is not recommended. Impella IIB Same as IABP none none Evolution of Heart Failure Classification ACC/AHA Stages: One-way progression A Risk B Asx Structural dx D= IV sx C Sx ever Refractory to Optimal Med Rx NYHA Symptom Class: Back and forth NYHA I II III NYHA IV e.g. Tx, VAD, Continuous Inotropes only indicated for Stage D INTERMACS Profiles INTERMACS: Interagency Registry for Mechanically Assisted Circulatory Support Green Bars DT LVAD vs Tx LVAD Body Size Tx Age Still w limits All sizes BSA<1.3 ?? No age limit 70 RV failure RVSWI PVR< 6 Wood U Restrictive CM Inadequate Yes Urgent Situations Assess Neuro Status Yes No Yes No Patient Selection for VADs • Severity of CHF • INTERMACS; HFSS; Seattle HFM • Exclude significant co-morbidity: if unclear support with short term device • Assess need for biventricular support • Assess need for short vs long term support • Assess peri-operative risk No severe end-organ dysfunction/failure Ability to tolerate anticoagulant or antiplatelet therapieswithout plans for correction NYHA CLASS ADULT PROFILES IV Ino IABP/V ent Official Shorthand INTERMACS LEVEL 1 X X “Crash and burn” IV INTERMACS LEVEL 2 X X “Sliding fast” on inotropes IV INTERMACS LEVEL 3 X “Stable” Continuous Ino-”Dependent” * IV INTERMACS LEVEL 4 Resting symptoms on oral therapy at home. ambul IV INTERMACS LEVEL 5 “Housebound”, Comfortable at rest, symptoms with minimum activity ADL ambuI IV INTERMACS LEVEL 6 “Walking wounded”-ADL possible but meaningful activity limited IIIB INTERMACS LEVEL 7 Advanced Class III III HeartMate IITM LVAS The HeartMate II LVAS (St. Jude Medical, Inc.) is a mechanical bearing axial continuous-flow blood pump; only device in the US approved for both Bridge-To-Transplant (BTT) and Destination Therapy (DT) patients Mehra MR, Naka Y, et al. Published Nov 16, 2016 at NEJM.org Estep J JACC 2015;66:1748 Estep J JACC 2015;66:1748 Adverse Events in ROADMAP Adverse Events OMM (n = 103) LVAD (n = 94) DT Trial§(EPPY) Bleeding 1 (1) [0.02] 44 (47) [1.22]‡ GI bleeding 1 (1) [0.02] 29 (31) [0.76]‡‖ Driveline infection — 9 (9.6) [0.14]‡ 0.22 Pump thrombus — 6 (6.4) [0.08]† 0.07¶ Pump exchange yr 1 — 4 (4.3) 2.10% Stroke 2 (2) [0.02] 8 (8.5) [0.09]∗ 0.08 Arrhythmias VT/VF 6 (5.8) [0.12] 17 (18.1) [0.23]∗ 0.46 Worsening HF# 36 (35) [0.68] 10 (10.6) [0.12]‡ — Rehospitalizations 64 (62) [1.43] 75 (79.8) [2.49]‡ 2.64∗∗ Composite event rate†† 39 (38) [0.83] 62 (66) [1.89]‡ Relative Risk (95% CI): OMM/LVAD: 0.44 (0.35).56) 1.13 — 2.09 HeartMate 3TM LVAS Magnetic HeartMate II LVAS Levitation Technology • • • Wide blood-flow passages to reduce shear stress The HeartMate 3 LVAS (St. Jude Medical, Inc.) is a centrifugal-flow, fully magnetically levitated blood pump Frictionless with absence of mechanical bearings engineered to minimize destruction of red blood cells and Intrinsic Pulse designed tothrombosis reduce stasis and avert thrombosis Mehra MR, Naka Y, et al. Published Nov 16, 2016 at NEJM.org Target Population • Patients with advanced heart failure and severe limitations (NYHA IIIB or IV), refractory to standard medical therapy and deemed as necessary candidates for left ventricular assist device implantation, irrespective of the intended goal of pump support (BTT or DT) • Key exclusion criteria included planned biventricular support, irreversible end-organ dysfunction, or active infection Study Design Patient meets MOMENTUM 3 eligibility criteria? HeartMate II HeartMate 3 Randomization 1:1 Short Term (ST) Cohort N=294 6-month follow-up Intent-to-Treat (ITT) Population N=294 HeartMate 3 N=152 HeartMate II N=142 Treatment failures Full Study Cohort N=1028 24-month follow-up for powered secondary endpoint Treatment failures (not treated with study device) (not treated with study device) N=1 N=4 Death: 1 As Treated Population N=289 Long Term (LT) Cohort N=366 24-month follow-up Implanted with HeartMate 3 N=151 Implanted with HeartMate II N=138 No LVAD implant: 1 Withdrawal of consent: 1 Transplant: 1 Implanted with non-study LVAD: 1 Study Endpoint • Primary Endpoint (composite, by ITT): • Survival at 6 months free of disabling stroke (modified Rankin score >3) or reoperation to replace or remove the pump (other than for recovery) • Demonstration of non-inferiority of HeartMate 3™ LVAS to HeartMate II™ LVAD Caution – HeartMate 3 LVAS is an investigational device. Limited by Federal (United States) law to investigational use SJM-HM3-1116-0003 | Item approved for global use. Baseline Characteristics Characteristic Age - years Mean Left ventricular ejection fraction - % Male sex - no. (%) Race – no. (%) White Black or African American Other* Body surface area - m2 Ischemic cause of heart failure - no. (%) History of stroke - no. (%) Concomitant medication or intervention - no (%) Intravenous inotropic agents IABP INTERMACS 2 INTERMACS 3 Bridge to Transplant (BTT) Bridge to Candidacy Destination Therapy (DT) HeartMate 3 (n=152) HeartMate II (n=142) 60 ± 12 17.1 ± 5.0 121 (80) 59 ± 12 17.3 ± 4.9 114 (80) 104 (68) 37 (24) 11 (8) 2.1 ± 0.3 68 (45) 12 (8) 107 (75) 24 (17) 11 (8) 2.1 ± 0.3 72 (51) 14 (10) 132 (87) 18 (12) 50 (33) 76 (50) 41 (27) 27 (18) 121 (85) 21 (15) 44 (31) 69 (49) 37 (26) 27 (18) 84 (55) 78 (55) Primary End Point Analysis (ITT) Survival at 6 months free of disabling stroke or reoperation to replace or remove the pump 1.00 HeartMate 3 Probability of Event Free Survival 86% 0.80 HeartMate II 77% 0.60 Non-inferiority Analysis Absolute difference +9.4% (95% LCB -2.1%), P<0.0001 0.40 Superiority Analysis HR 0.55, (95% CI 0.32-0.95), P=0.037 0.20 0.00 no. at risk HeartMate 3 152 0 HeartMate II 142 146 125 1 138 119 1352 116 130 110 Months 3 128 106 1274 103 5 6 Primary Endpoint (ITT) HeartMate 3 (n=152) n (% [95%CI]) HeartMate II (n=142) n (% [95%CI]) Superiority Analysis Survival free from disabling stroke and reoperation to repair or replace the LVAD at 6 months Hazard Ratio† P value 131 (86.2 [80 - 91]) 109 (76.8 [69 - 83]) 0.55 (0.32 - 0.95) 0.037 1(1[0-4]) 4 (3 [1 - 7]) 0.23 (0.03 – 2.09) 0.15 Disabling stroke (Rankin Score > 3) 6 (4 [1 - 8]) 4 (3 [1 - 7]) 1.31 (0.37 - 4.64) 0.59 Reoperation to repair or replace pump* 1 (1 [0 - 4]) 11 (8 [4 - 13]) 0.08 (0.01 - 0.60) 0.002 13 (9 [5 - 14]) 14 (10 [6 - 16]) 0.82 (0.38 - 1.73) 0.70 First event that prevented patient from reaching the primary endpoint Did not receive assigned pump Death within 180 days after implant †Hazard ratios were calculated with the use of Cox regression. * includes two cases of urgent heart transplant due to device malfunction in the axial-flow pump group CI denotes confidence interval and LVAD left ventricular assist device Caution – HeartMate 3 LVAS is an investigational device. Limited by Federal (United States) law to investigational use SJM-HM3-1116-0003 | Item approved for global use. * Conclusions • Short and long term mechanical support devices are being used for the treatment of cardiogenic shock and Stage D Heart Failure • There are continued improvements in pump design • Short term devices have not yet been shown to improve survival in cardiogenic shock but clearly provide greater hemodynamic support • Adverse events remain common in the use of durable device support