Disclosures. Overcoming TAH Challenges: Innovation in PT Practice. Learning Objectives. Outline. Cedars-Sinai Medical Center.

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1 Disclosures Overcoming TAH Challenges: Innovation in PT Vicky Hu no relevant financial relationship exists Suzanne Seidel no relevant financial relationship exists Suzanne Seidel, PT, CCS Vicky Hu, PT, DPT, CCS, CSCS Cedars-Sinai Medical Center APTA Combined Sections Meeting Anaheim, California February 17-20, 2016 Learning Objectives 1. Explain the indications and contraindications for use of Total Artificial Heart (TAH) 2. Describe indications and contraindications for timing of physical therapy related to TAH 3. Describe physical therapy progression and functional outcomes for TAH patient population 4. Recognize critical elements from case examples that impact PT practice Outline Introduction TAH mechanics, indications/contraindications to TAH implantation Pathophysiology necessitating TAH implantation Indications/contraindications, early mobilization with TAH with physical therapy Research study highlighting the optimal timing of physical therapy including barriers to early mobilization Case examples to illustrate physical therapy intervention from TAH implant to transplantation Implications and strategies for optimal physical therapy practice with the TAH patient population Q&A Cedars-Sinai Medical Center Primary service area includes 3.3 million people 962 beds including 24 cardiothoracic ICU, 24 step-down unit, 32 advanced heart failure unit : 241 heart transplants, 47 Total Artificial Heart implants Introduction Current standard of care for end-stage heart failure is cardiac transplantation As of 11/13/2015, approximately 4,200 people are listed with UNOS National organ transplant registry waiting for a heart transplant, 350 of those are in California (8%) Status 1A 479, Status 1B 1787 Status Status Approximately 2,200 donor hearts are available each year in the US Mechanical circulatory support is increasingly being utilized to treat end-stage heart failure, as bridge to transplant UNOS, 2015 Copeland, Arabia, Tsau, et al 2003 Copeland, Smith, Arabia, et al 2004 without permission. 1

2 INTERMACS Interagency Registry for Mechanically Assisted Circulatory Support Facilitate refinement of patient selection to maximize outcomes with current and new device options Identify predictors of good outcomes, risk factors for adverse events after device implant Develop consensus best practice guidelines to improve clinical management by reducing short and long term complications Guide clinical application, improvements in technology, and evolution of next generation devices INTERMACS, 2015 INTERMACS Clinical Profile Time Frame for Intervention 1. Critical cardiogenic shock crash and burn Within hours 2. Progressive decline on inotrope support sliding on inotropes 3. Stable but inotrope dependent dependent stability 4. Resting symptoms, recurrent heart failure frequent flyer Within few days Elective, over a few weeks to months 5. Exertion intolerant housebound Variable urgency, depends on maintenance of 6. Exertion limited walking wounded nutrition, organ function, and activity 7. Advanced NYHA III symptoms placeholder Not currently indicated Mechanical Circulatory Support Indications Frequent hospitalizations for heart failure Intolerance to neurohormonal antagonists NYHA IIIb IV functional limitations despite optimal maximal therapy End-organ dysfunction owing to low CO Increasing diuretic requirement Cardiac resynchronizing therapy nonresponder Inotrope dependence Low peak VO2 (< 14 ml/kg/min) Mechanical Circulatory Support Contraindications Relative Age 80 y for DT Obesity or malnutrition MS disease that impairs rehabilitation Active systemic infection or prolonged intubation Untreated malignancy Severe PVD Active substance abuse Impaired cognitive function Unmanaged psychiatric disorder Lack of social support Absolute Irreversible hepatic disease Irreversible renal disease Irreversible neurological disease Medical nonadherence Severe psychosocial limitations Mechanical Circulatory Support Implant Strategies Bridge to recovery Bridge to transplant (BTT) Destination therapy (DT) Bridge to candidacy without permission. 2

3 Bridge to Recovery Temporary maintenance of circulation after an acute event, during which time the heart is expected to recover, and mechanical support is then removed without need for transplant Patients with reversible cardiac insults such as cardiogenic shock, peripartum cardiomyopathy Too high risk for durable implantable MCS device Allows stabilization, and clarification of potential cardiac recovery or reversal of other medical issues that may interfere with transplantation or durable implantable MCS device placement Non-durable MCS Temporary/rescue devices: Intra-aortic balloon pump Extracorporeal membrane oxygenation Percutaneous TandemHeart Impella 2.5 Extracorporeal CentriMag (Thoratec pvad) Bridge to Transplant Transplant candidate that would not survive, or would develop progressive end-organ dysfunction from low cardiac output before an organ becomes available Improve survival, functional status, quality of life particularly for those predicted to have a long wait for an appropriate donor Reverse or prevent end-organ dysfunction Destination Therapy Not transplant candidate but need long term support Failed to respond to optimal medical management for 45 of last 60 days, or balloon pump dependent for 7 days, or IV inotrope dependent for 14 days EF < 25% Demonstrates functional limitation with peak VO2 14 ml/kg/min unless balloon pump or inotrope dependent, or physically unable to perform the test Centers for Medicare & Medicaid Services, 2013 Bridge to Candidacy Not currently listed for transplant Potential for recovery unclear No absolute or permanent contraindication to transplantation Transplant eligibility dependent on condition after device implantation Development or resolution of comorbidities Durable MCS Devices Thoratec HeartMate II BTT, DT Thoratec pvad BTT, DT HeartWare HVAD BTT, (DT) SynCardia Total Artificial Heart BTT, (DT) without permission. 3

4 Overcoming TAH Challenges: Innovation in PT MCS Common Components Thoratec CentriMag Pump Driveline System controller/console Power source External Short term 6 hrs, up to 30 days Magnetically-levitated pump impeller continuous blood flow Pump speed up to 5,500 RPM Cardiac output up to 9.9 L/min Reprinted with the permission of Thoratec Corporation Thoratec pvad Thoratec HeartMate II External Rigid plastic housing, 2 chambers separated by polyurethane membrane Pneumatic compressor shuttles air in/out pulsatile SV = 65 ml CO up to 7.1 L/min Auto/fixed rate up to 110 bpm Reprinted with the permission of Thoratec Corporation HeartWare HVAD Internal pump, 160 g (5.6 oz) Motor speed RPM, recommended RPM Impeller spins blood, continuous flow cardiac output up to 10 L/min Calculated by pump power and speed, hematocrit Courtesy: HeartWare, Inc. without permission. Internal pump, 10 oz implanted beneath diaphragm, in preperitoneal or intra-abdominal space Rotor (magnet), located inside a thin-walled titanium duct 12 mm in diameter, spins on bearings 6,000-15,000 RPM (normal 8,00010,000 RPM) Continuous flow, cardiac output 3-10 L/min Designed for several years of circulatory support BTT, DT Reprinted with the permission of Thoratec Corporation SynCardia Total Artificial Heart Internal pump, 160 g (5.6 oz) 70 cc or 50 cc sizes Replaces both ventricles, all 4 valves Pneumatic pulsatile Physiological response partial fill (3/4), full eject SV up to 70 ml (or 50 ml) CO up to 9.5 L/min Fixed rate, bpm Courtesy: 4

5 TAH Indications Bridge to transplantation Transplant eligible At risk of imminent death from non-reversible biventricular failure Destination therapy (investigational) Ineligible for cardiac transplantation Remote likelihood of becoming eligible for a transplant TAH Contraindications Patients who do not have sufficient space in the chest < 10 cm distance between the sternum and T10 measured by CT scan Body surface area < 1.7 m 2 for 70 cc > 1.85 m 2 for 50 cc Patients who cannot be adequately anticoagulated Big Blue Freedom Driver C2 hospital driver cart, caddy Courtesy: Courtesy: Typical settings Beat Rate: 125 ± 15 bpm Right Drive Pressure: mmhg Left Drive Pressure: mmhg Right Vacuum Pressure: 0 (-10) mmhg Left Vacuum Pressure: 0 (-13) mmhg Left Vacuum typically greater than Right Vacuum Freedom Driver Multi-component electro-mechanical unit designed to provide pneumatic power to implanted TAH Intended for in-hospital and out-of-hospital use Weighs 13.5 pounds, wearable power supply Only beat rate is adjustable Allows clinically stable TAH patients to be discharged home to wait for transplantation instead of in the hospital % Systole: 50 ± 5 % without permission. 5

6 Freedom Driver Pathophysiology Necessitating TAH Biventricular heart failure final common pathway of all cardiovascular disease Pediatric and adult congenital conditions Cardiomyopathy Persistent ventricular tachycardia Refractory cardiogenic shock Transplant rejection Acquired VSD Cardiac amyloidosis INTERMACS profile 1 or 2 Courtesy: Benefits of TAH Eliminates native heart complications: Arrhythmias Failing ventricles Malfunctioning heart valves Shortest blood path of any MCS device CO up to 9.5 L/min speeds recovery of vital organs Highest bridge to transplant rate 79% Immediately available TAH and Patient Recovery Within 2 weeks: 65% of core patients were OOB by post-op day 5 60% of core patients were walking > 100 ft at 2 weeks after implant Liver function returned to normal Kidney function improved significantly, trending to normal FDA Summary of Safety and Effectiveness, 2004 TAH and Physical Therapy Limited published research regarding PT intervention after TAH implantation Comparison of BP response following TAH vs LVAD implantation Single patient case studies Early progressive mobilization Utilizing previously established guidelines for patients with heart failure and MCS Canada and Flattery, 2012 Kohli, Canada, Arena, et al, 2011 Nicholson and Paz, 2010 Fernandez and Ford, 2014 Indications/Contraindications to Initiating PT Medically stable, chest closed Able to follow simple commands Abdominal binder to secure driveline No telemetry monitoring necessary Monitor signs/symptoms of exercise intolerance, orthostasis, vitals BP, O2 sat, RR, RPE/Borg Monitor device rate, flow, volume Partial fill, full eject Ensure power source, air tanks sufficient for duration of session without permission. 6

7 PT Progression/Functional Outcomes Case Examples Acknowledgements Acute Therapy Physical Therapy Staff especially the cardiac physical therapy team Lorraine Kimura, PT, Acute Therapy Manager Diane Salgado, PT and Louise Wall, PT, Therapy Supervisors Pamela Roberts, PhD, CPHQ, FNAP, Program Director Syncardia Systems, Inc. Accessed November 17, SynCardia CardioWest TAH Instructions for Use. Accessed January 22, UNOS Donation and Transplantation Data. Accessed November 16, Copeland JG, Arabia FA, Tsau PH, Nolan PE, McClellan D, Smith RG. Total artificial hearts: bridge to transplantation. Cardiol Clin. 2003; 21(1): Copeland JG, Smith RG, Arabia FA, Nolan PE, Sethi GK, Tsau PH, et al. Cardiac replacement with a total artificial heart as a bridge to transplantation. N Engl J Med. 2004; 351(9): Accessed November 17, INTERMACS Website. INTERMACS Quarterly Statistical Report: June 30, 2015 Q2. Interagency Registry for Mechanically Assisted Circulatory Support, National Heart Lung and Blood Institute. Contract Award HHSN C. Accessed November 26, Peura JL, Colvin-Adams M, Francis GS, Grady KL, Hoffman TM, Jessup M, et al. Recommendations for the use of mechanical circulatory support: device strategies and patient selection: a scientific statement from the American Heart Association. Circulation. 2012; 126: doi: /cir.0b013e a54. Stewart GC, Givertz MM. Mechanical circulatory support for advanced heart failure patients and technology in evolution. Circulation. 2012; 125: doi: /circulationaha Stevenson LW, Pagani FD, Young JB, Jessup M, Miller L, Kormos RL, et al. INTERMACS profiles of advanced heart failure: the current picture. J Heart Lung Transplant. 2009; 28(6): doi: Jacques L, Jensen TS, Schafer J, Smith K, Casey M, Lotfi R. Decision memo for ventricular assist devices for bridge-to-transplant and destination therapy (CAG-00432R). Centers for Medicare and Medicaid Services. Published October 30, Accessed November 25, Thoratec Corporation. Accessed November 30, HeartWare. Accessed November 30, without permission. 7

8 FDA Summary of Safety and Effectiveness Data. March 17, Accessed November 30, Canada J, Flattery, M. Exercising the patient with a mechanical circulatory support device. International Society of Heart Lung Transplantation Links. 2012; 3(8). Flattery.html. Accessed November 17, Kohli H, Canada J, Arena R, Tang D, Peberdy M, Harton S, et al. Exercise blood pressure response during assisted circulatory support: Comparison of the total artificial heart with a left ventricular assist device during rehabilitation. J Heart Lung Transplant. 2011; 30(11): Accessed November 17, Fernandez N, Ford K. Early progressive mobilization and physical therapy management in a patient with a total artificial heart device. Cardiopulm Phys Ther J. 2014; 25(1): Nicholson C, Paz J. Total artificial heart and physical therapy management. Cardiopulm Phys Ther J. 2010; 21(2): Accessed January 22, Holman WL. Interagency registry for mechanically assisted circulatory support (INTERMACS): what have we learned and what will we learn? Circulation 2012; 126: doi: /CIRCULATIONAHA Jaroszewski DE, Anderson EM, Pierce CN, Arabia FA. The SynCardia freedom driver: A portable driver for discharge home with the total artificial heart. 2011; 30(7): doi: /j.healun Pierce C, Staley L, Bright H. The total artificial heart patient: building the bridge from implant to transplant. [PowerPoint Slides]. American Association of Cardiovascular and Pulmonary Rehabilitation 28th Annual Meeting MSyllabus/S401_Bright,%20Pierce,%20Staley.pdf. Accessed January 22, Kirsch M, Mazzucotelli JP, Roussel JC, Bouchot O, N Loga J, Leprince P, et al. Survival after biventricular mechanical circulatory support: Does the type of device matter?. J Heart Lung Transplant. 2012; 31(5): doi: /j.healun Barnard J, Tsui S. The total artificial heart in a cardiac replacement therapy programme. Br J Hosp Med. 2012; 73(12): Shah KB, Tang DG, Cooke RH, Harton S, Flattery M, Katlaps GJ, et al. Review: Implantable mechanical circulatory support: Demystifying patients with ventricular assist devices and artificial hearts. Clinical Cardiology. 2011; 34: doi: /clc Johnson W. Editors pick: Total artificial heart transplants: Future or biding time? Royal College of Surgeons in Ireland Student Medical Journal. 2011; Accessed November 17, without permission. 8