Surgical Options for Temporary MCS
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1 Surgical Options for Temporary MCS Michael A. Acker, MD Julian Johnson Professor of Surgery Chief of Cardiovascular Surgery Director of Heart and Vascular Center University of Pennsylvania Health System
2 Goals of Temporary/Percutaneous Mechanical Circulatory Support in Cardiogenic Shock Eliminate shock and support end-organ function Allows neurologic recovery Relatively inexpensive means of triage Bridge to revascularization ± mechanical repair (Limit infarct size-theoretical) Potential for Recovery Allows time to optimize for durable long-term VADs BTT; DT; heart Transplant Terminal weaning.death Division of Cardiothoracic Surgery University of Pennsylvania
3 National Trends in the Utilization of Short-Term Mechanical Circulatory Support (STCS) LVAD PercTCS Surgical TCS From 2007 to 2011, use of percutaneous devices for short-term MCS increased by 1,511% compared with a 101% increase in non-percutaneous devices. J Am Coll Cardiol 2014;64:
4 MCS in Cardiogenic Shock: Management Algorythm Acute Refractory Cardiogenic Shock Medical Therapy IABP Temporary VAD/ECMO Support Rapid Deterioration (hrs) Revascularization, surgery Recovery/Assessment Long-term MCS Days -Weeks MSOF Neurologic Deficit MCS Explant Palliative Care Rehabilitation Bridge to Transplant Destination Therapy Bridge to Recovery Gregoric I, Bermudez C. Braunwald Comp., Mechanical Support 2011
5 Temporary Devices Available and Characteristics TandemHeart LVAD RVAD Impella CP / RP ECMO Impella 5.0 Temp. VADs Surgical Bedside Implantation No No Yes (No in CC) No No Flow l/min LV Unloading Yes Yes Partially*** (YES in CC) Yes Yes RV support No YES* No YES** Yes NoYES** Yes Pulmonary support Duration of support No No Yes No no Days-weeks? Days-week? < 2 weeks weeks Months Insertion Percut. Percut. Percut. Graft Stern. Cannula Size Fr flvad 30 Fr for RVAD 9 Fr,13F Sheath Fr 9Fr, 21FR Pump (LD) * TH-Protek Duo ** Impella RP *** Peripheral ECMO 5
6 Surgical Temporary Mechanical Support Options Centrifugal Pump (Centrimag, Rotaflow) Thoratec PVAD Impella 5.0 LVAD / RVAD/BiVAD Membrane Oxygenator Central Cannulation - Peripheral Ischemia - LV decompression Inflow: LA, LV RA, RV, Femoral Vein, SVC Outflow: Aorta, femoral, axillary PA Exit sites Attempt to tunnel cannula/tubing Close sternum with 3 wires Plan for permanent VAD if possible
7 Clinical outcome of mechanical circulatory support for refractory cardiogenic shock in the current era. (CPR) Takayam et al ( Columbia) Overall SV 7 Entire cohort 44 pts (49%) survived to hospital discharge. 92 % (44 of 48) survived to hospital discharge if reached destination- VAD/OHT/recovery 7
8 Bridge-to-Decision Therapy With a Continuous-Flow External Ventricular Assist Device in Refractory Cardiogenic Shock of Various Causes 143 pts (148 Cmag) 70.6% Intermacs 1 69% (30 day) 49% 8 Circ Heart Fail. 2014;7:
9 Bridge-to-Decision Therapy With a Continuous-Flow External Ventricular Assist Device in Refractory Cardiogenic Shock of Various Causes Complications Outcomes Takayama et al.circ Heart Fail. 2014;7:
10 Centrimag Minimally Invasive Approach 10
11 Novel minimally invasive surgical approach using an external ventricular assist device and extracorporeal membrane oxygenation in refractory cardiogenic shock 25 pts in CS ADHG (52%) AMI (48%) Mean Arterial Flow (l/min) 5.3±1.1 Mean duration of support 28±14 d Procedure performed off CPB 68 % Survival to Discharge Takeda et al, European Journal of Cardio-Thoracic Surgery 0 (2016)
12 Percutaneous Temporary Circulatory Support Options LV Support Impella RP Tandem Heart-Protek-Duo ECMO RV Support
13 Cardiogenic Shock : Limits of percutaneous support? IMPELLA3.5 IABP ECMO 13
14 14 IABP-SHOCK II Trial (Thiele et al, NEJM 2012)
15 EuroShock Registry: Impella patients with AMI/CS 35% 30d SV In patients with AMI-CS Impella 2.5 treatment is feasible, reduces lactate however early mortality remains high. Lauten et al. Circ Heart Failure
16 Outcomes of Patients Receiving Temporary Circulatory Support Before Durable Ventricular Assist Device Mechanical Circulatory Support Research Network TCS pts sicker than Profile 1 Conclusions. Temporary circulatory support restores hemodynamics and reverses end-organ dysfunction. Nevertheless, these patients have high residual risk with postoperative morbidity and mortality that parallels profile 1 patients without TCS. Shah et al.ann Thorac Surg 2017;103:
17 Percutaneous left ventricular assist devices vs. IABP for treatment of cardiogenic shock: a meta-analysis of controlled trials Tandem Heart Impella 2.5 Cheng et al. European Heart Journal 2009l doi:
18 IMPELLA CP (3.5) in CS : IMPRESS trial 48 pts with STEMI complicated with CS (MV, SBP <90mmhg 30 min, need of inotropes randomized to Impella CP or IABP All patients had primary PCI and 92 % had CA before randomization All cause mortality was 50 % in the IMPELLA group vs 46% in the IABP group (HR 0.96,95%Cl ). Similar SV at 6 months 50%. Similar CVA rate, 1 major vasc complication in the IMPELLA group, 8 vs. 2 bleeding events in the IMPELLA vs IABP group (3-1 deviced related ). Similar LVEF on follow up 46% IMPELLA and 49% IABP IMPELLA CP DOES NOT PROVIDE A SURVIVAL ADVANTAGE OVER IABP IN PATIENTS WITH STEMI-CS AND ITS USE MAY BE ASSOCIATED WITH INCREASING BLEEDING COMPLICATIONS. TCT
19 Inadequate unloading LV using Percutaneous Support (Impella CP) 19
20 IMPELLA Registry CS Patients: 2.5 =189 CP = /LD= 24 IMPELLA Registry, Summary of Safety and Effectiveness Data.PMA Appl
21 Short-term mechanical circulatory support with Impella 5.0 for CS La Pitie 14 patients,7 STEMI-7 PC 57.2 % SV at 2 years 43% weaning from Imp % bridge to VAD Average support 8 days Mastroiani et al, European Heart Journal: Acute CV Care
22 48 patients 80% Impella % Recovered LV Fx 8% Bridge to VAD
23 AMBULATION WITH IMPELLA AXILLARY APPROACH Impella Axillary Approach Implantable LVAD / Sternotomy 22 * Impella 5.0 patient pictured ICU patient
24 IMPELLA 5.0 vs ECMO 38% Mortality 30 days with Impella % Mortality 30 days with ECMO Lamarche, JTCVS 2011,142:
25 Impella RP: Percutaneous Right Ventricular Assist Device Pump outflow in PA Transfemoral venous insertion Pump Outflow in IVC 3D shaped cannula RCT 30 pts completed In post LVAD and Post MI RVF FDA Approval Sept Fr motor housing Pump mounted on a 11Fr catheter Flow: 4 33,000 rpm Anticoagulation: ACT ~ sec Approved Sept, 2017
26 Mechanical Circulatory Support for Right Ventricular Failure ( THRIVE Registry) : Surgical and percutaneous RVAD Total mortality 57 % (50% in the PRVAD) and lower in LVAD and AMI group. Increased age, biventricular failure, and major bleeding were associated with increased in-hospital mortality. Use of the CF-RVSD for RVF is clinically feasible and associated with improved hemodynamic status Higher flows with surgical RVADs and better decompression Kapur et Al J Am Coll Cardiol HF 2013;1:127 34) 26
27 27
28 Extracorporeal Membrane Oxygenation Rapid deployment Central or Peripheral Right, left, biventricular Cardio-pulmonary support? LV decompression Inexpensive
29 Penn ECMO Contraindications Veno-Arterial (VA) ECMO Contraindications Age > 75 (except failure to wean from CPB) Active malignancy: with estimated survival<1 yr Severe peripheral vascular disease Chronic respiratory failure (COPD on home O2) Advanced chronic liver disease Acute aortic dissection Severe aortic valve regurgitation Current intracranial hemorrhage Witnessed CPR > 60 min (in the absence of ROSC) Unwitnessed arrest > 5 min Veno-Arterial (VA) ECMO Relative Contraindications End stage renal disease on hemodialysis or peritoneal dialysis with acute cardiovascular collapse Severe baseline disability (significant dementia, quadriplegia, etc.) which would inhibit ventilator weaning/rehabilitation Weight >140kg 29
30 Percutaneous Technique and Distal Leg Perfusion on VA ECMO to minimize vascular complications. FV Near Infrared Spectroscopy Fr Fr FA 8Fr Distal LE perfusion using cannula may be superior to sheath introd. Rhino Dilator The incidences of limb ischemia and limb ischemia requiring surgical intervention were significantly higher for the introducer sheath compared with the cannula (30.6 vs. 15.6% and 15.4 vs. 6.25%, respectively). Artificial Organs 2014, 38(11): /17 (30%) pts patients had persistent unilateral lower limb oximetry events, which resolved upon placement or replacement of a distal perfusion cannula. Artificial Organs 2012, 36(8):
31 Concomitant implantation of Impella on top of veno-arterial extracorporeal membrane oxygenation may improve survival of patients with cardiogenic shock. Prospective match cohort Concomitant treatment with VA-ECMO and Impella may improve outcome in patients with cardiogenic shock compared with VA-ECMO only. (Propensity Matched) Pappalardo et al European Journal of Heart Failure (2016) doi: / 31
32 ECMO Conceived as a therapy for respiratory failure Provides a temporary cardiac output in Veno-Arterial configuration Promoter of LV Recovery Direct Ventricular Mechanical Unloading Termination of systemic shock Low inflammation Preload optimisation Improved Coronary Perfusion Reverse Remodeling VA-ECMO Ventricular Afterload Increased Normally effective at terminating shock Inflammatory insult Little direct preload control Marginal effect on coronary perfusion No evidence of VA-ECMO induced reverse remodeling
33 A PROSPECTIVE RANDOMISED TRIAL OF EARLY LV VENTING USING IMPELLA CP FOR RECOVERY IN PATIENTS WITH CARDIOGENIC SHOCK MANAGED WITH VA ECMO (REVERSE) Investigators from Cardiac Surgery, HF and Interventional Cardiology and Critical Care at HUP, PPMC, LGH 96 patients over 3 sites Balanced for aetiology, sex and age 48 VA-ECMO 48 VA-ECMO + Impella Randomised within 12 hours of VA-ECMO when screening criteria met Impella inserted within 12 hours of randomisation, maximum of 24 hours since ECMO institution
34 MCS Overview Hospital Cost Temporary Extracorporeal Permanent Intracorporeal ECMO Heart Assist Devices Heart Assist Devices ECMO anomaly: lower cost but higher revenue vs. temporary devices Percutaneous Surgical HeartMate III HeartMate III Impella Centrimag HeartWare Tandem RotoFlow SynCardia Hospital Revenue 34
35 Three primary cost factors 1. Device cost can vary widely SynCardia $130K Heartmate II, III & Heartware $70 $100K per kit Impella 2.5 / 5.0 $25K / $28K Tandem $20K (plus equipment rental) Centrimag ECMO $9K Rotoflow $2K (plus capital investment) 2. Length of Stay varies widely 3. Site of Stay ICU days versus Med/Surg days SICU days are twice as costly 35
36 Summary 36 TMCS are increasingly used as a bridge to decision in patients with CS. The technical simplicity and lack of definite guidelines has favored the use of percutaneous technologies, without evidence supporting their superiority over surgically implanted devices. The limitations of flow and LV unloading of percutaneous TCS leads frequently to the need to combine devices increasing vascular complications and hemolysis, with unclear effects on clinical outcomes and recovery. Surgically implanted devices provide longer and more stable support with adequate flow and LV unloading, with the potential to facilitate recovery and second destination and should be considered as first option in patients where percutaneous support may not be sufficient or may be contraindicated. As the indications and type of support needed may vary, the use of TMCS should be directed by an experienced team (Shock Team) capable of defining the correct candidate and destination alternatives, but also with the experience to identify futile support. 36
37 Percutaneous (non-surgical) vs Surgical approach in CS. When things get rough who do we call? Interventional Cadiologist VAD/ECMO Surgeon SHOCK TEAM 37
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MANAGEMENT OF CARDIOGENIC SHOCK
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ECMO BASICS CHLOE STEINSHOUER, MD PULMONARY AND SLEEP CONSULTANTS OF KANSAS
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Left Ventricular Assist Devices (LVADs): Overview and Future Directions
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LVAD Complications, Recovery
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Overview of MCS in Bruce B Reid, MD Surgical Director Artificial Heart Program/Heart Transplantation
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Preoperative intraaortic balloon counterpulsation in high-risk CABG Stefan Klotz, M.D. Preoperative IABP in high-risk CABG Questions?? Useful? Definition of High-risk? Pre-OP/Intra-OP/Post-OP? Complication
Risk Factors for Adverse Outcome after HeartMate II Jennifer Cowger, MD, MS St. Vincent Heart Center of Indiana
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Description. Section: Surgery Effective Date: April 15, Subsection: Transplant Original Policy Date: September 13, 2012 Subject:
Last Review Status/Date: March 2016 Page: 1 of 30 Description Mechanical devices to assist or replace a failing heart have been developed over many decades of research. A ventricular assist device (VAD)
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How to do Primary Angioplasty. - Patients with Cardiogenic Shock
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Name of Policy: Ventricular Assist Devices and Total Artificial Hearts
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ECMELLA. Associate Prof. Dirk Westermann, MD, PhD. Department of General and Interventional Cardiology Hamburg, Germany. Department of Medicine
ACS in Women ECMELLA Combined Impella and ECMO in Cardiogenic Shock Prof. Peter Clemmensen, MD, DMSc, FESC, FSCAI Associate Prof. Dirk Westermann, MD, PhD University Heart Center Hamburg-Eppendorf Department
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Implantable Ventricular Assist Devices and Total Artificial Hearts Policy Number: Original Effective Date: MM.06.017 05/21/1999 Line(s) of Business: Current Effective Date: PPO; HMO; QUEST Integration