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Advanced Therapy for Heart and Lung Failure June 8, 2012 Alan Simeone, M.D. Johns Hopkins Cardiac Surgery Please Ask Questions Today’s Discussion • End-Stage Heart Failure – Heart Transplantation – Mechanical Circulatory Support • End-Stage Lung disease – Lung Transplantation Common Causes of Heart Failure • Ischemic Cardiomyopathy (60%) • Non-Ischemic Cardiomyopathy • • • • • • Idiopathic Hypertensive Valvular Toxin-induced Infectious/Inflammatory Result of Congenital Disease Classification New York Heart Association (NYHA) Heart Failure Symptom Classification System American College of Cardiology-American Heart Association Classification of Chronic Heart Failure • I: No symptom limitation with ordinary physical activity • • II: Ordinary physical activity somewhat limited by dyspnea (e.g., long-distance walking, climbing two flights of stairs) A: High risk for developing heart failure: Hypertension, diabetes mellitus, CAD, family history of cardiomyopathy • B: Asymptomatic heart failure: Previous MI, LV dysfunction, valvular heart disease • C: Symptomatic heart failure: Structural heart disease, dyspnea and fatigue, impaired exercise tolerance • D: Refractory end-stage heart failure: Marked symptoms at rest despite maximal medical therapy • • III: Exercise limited by dyspnea with moderate workload (e.g., short-distance walking, climbing one flight of stairs) IV: Dyspnea at rest or with very little exertion Low Ejection Fraction Heart Failure 400,000 Americans Hospitalized yearly despite best medical therapy When Hospitalization Required • 30 to 50% re-admitted within the first 6 months One Year Mortality Class II: 10 - 15% Class III: 15 – 25% Class IV: 30 – 50% The Survival numbers are even worse with more advanced Heart Failure Clearly, better treatment options are needed Heart Transplantation Mechanical Circulatory Support History – Heart Transplantation • First success 1967 in South Africa • 54 year old man with Ischemic Cardiomyopathy • Donor a 24 year old woman • Lived 18 days pneumonia • Initial Enthusiasm • Poor results • Most gave up • Norman Shumway at Stanford persisted with an organized research program • Cyclosporine, first used in 1980, helped improve long-term results • This rekindled interest in Heart Transplantation • Over 44,000 have been performed in the U.S. Current Results • One-year survival about 90 percent • Three-year survival 80 percent • Ten-year survival 50 percent Dilated, End-Stage Cardiomyopathy Transplant for End-Stage Heart Failure • Transplant Evaluation – – – – Medical Psychological Social Financial • Goal is to ensure that transplant is the right treatment for the patient and maximize chance of a successful outcome Contraindications to Cardiac Transplantation Pulmonary Hypertension Diabetes with End-Organ Dysfunction Immunologic Sensitization Severe Lung or Liver Disease Active Malignancy Psychosocial Deficiencies Substance Dependence Documented Medical Noncompliance Kidney Disease with GFR<40 Tobacco Use in previous 6 Months Advanced Age Symptomatic Vascular Disease Obesity, BMI>30 History of Malignancy Donor Heart Allocation • Status (How sick are you?) • • • • • 1A, 1B, 2 Age (pediatric or adult) Blood Type Distance from Donor Hospital Time accrued on the waitlist Other factors, such as size, weight, sex, HLA typing The Surgery • Early Risks • • • • • • • • • Death Stroke Bleeding/Transfusion/Return to Operating Room Infection Other Organ Dysfunction Primary Graft Dysfunction Rejection Right Ventricular Failure Respiratory Failure • Late Risks and Important Issues • Rejection • Infection • Graft Coronary Disease Immunosuppressive Drugs Steroids, FK 506, CellCept Commitment to close Follow up and Monitoring The Process • • • • • Donor organ offered to a specific recipient Organ accepted for a specific recipient You get the call to head to JHU Procurement team heads off to donor hospital Once heart quality is confirmed and timing settled a “Go Call” is made • The recipient moves to the operating room • In the Operating Room • • • • • • • • • • • Sedation Arterial catheter General anesthesia, breathing tube Large neck IV catheter, Pulmonary Artery Catheter Sterile Surgical Prep and Drape Median Sternotomy Incision Heart/Lung Bypass Circuit Sick Heart removed when new heart “on the ground” New Heart implanted, allowed to beat and recover Hardware removed Heart/Lung Bypass weaned off Median Sternotomy Incision Heart-Lung Bypass Relevant Anatomy The Empty Chest The Diseased Heart The Donor Heart on Ice The Left Atrial Anastomosis • In CVSICU • • • • • Sedated, on the ventilator, with a breathing tube, Nitric Oxide Multiple chest drains Catheter in bladder for urine IV drugs to support heart function and blood pressure Possibly a Balloon Pump or other advanced support device Milestones to achieve • Stability (blood pressure, heart and lung function) • No Bleeding • Normal Brain Function Post-Transplant, in the ICU • When those Goals have been reached • Wean from Ventilator, remove breathing tube (Extubation) • Wean off any other Advanced Support Device • Remove Pulmonary Artery Catheter • Out of Bed! • Deep Breathe and Cough to prevent pneumonia and respiratory failure • When Stable, move out to Step Down Unit • On Step Down Unit • • • • • • • • • • Breath, Cough, Walk Eat Move bowels Pee (diurese) Wean off Oxygen Remove tubes, drains, etc. First Right Heart Catheterization and Biopsy at 7 days Remove temporary pacing wires Get medications adjusted correctly Discharge Post-transplant, ready to go home The Bad News 2322 hearts were transplanted in the U.S. in 2011 3202 people are on the national waitlist Listing Issues • Median Times on the Waitlist by Blood Type O 327 days A 111 days B 102 days AB 31 days • The “High-Risk” Donor Mechanical Circulatory Support An Interesting History & Current Devices Concepts • Bridge to Recovery • Bridge to Transplant • Bridge to Decision • Destination Therapy First LVAD (Left Ventricular Assist Device) 1963 Liotta and Crawford 1966 DeBakey and Liotta Current Devices Heartmate II HeartWare Current Devices Heartmate II HeartWare Current Devices Heartmate II HeartWare First Total Artificial Heart (TAH) • Cooley, DeBakey and Liotta • 1969 • First Bridge to Transplant • Pneumatic Device • Dacron and Silastic First TAH Other Support Devices Thoratec PVAD Heartmate II Lung Transplantation Dr. James Hardy Dr. Joel Cooper NUMBER OF LUNG TRANSPLANTS REPORTED BY YEAR AND PROCEDURE TYPE 2196 2200 2000 Bilateral/Double Lung Single Lung 1600 1366 1229 1400 1200 1924 1789 1788 1615 1574 1461 14571481 1375 1087 923 1000 707 800 600 418 400 189 200 45 83 15 14 ISHLT 2008 J Heart Lung Transplant 2008;27: 937-983 06 20 05 20 04 20 03 20 02 20 01 20 00 20 99 19 98 19 97 19 96 19 95 19 94 19 93 19 92 19 91 19 90 19 89 19 88 19 87 19 86 19 85 0 19 Number of Transplants 1800 2168 NOTE: This figure includes only the lung transplants that are reported to the ISHLT Transplant Registry. As such, this should not be construed as representing changes in the number of lung transplants performed worldwide. Lung Transplant 2011 Wait list 1655 Transplants 1822 How are Lung Offers Allocated • Patients are matched by blood type and size • Patients are listed by Lung Allocation Score (LAS) – Based on the chance of Dying while waiting • Time on the list doesn’t matter anymore Adult Lung Transplant Diagnoses 50% 45% COPD 40% 37% Percent of total 35% 30% 31% IPF 25% Other 20% 19% CF 15% 13% 10% LAS implemented May 2005 5% 0% 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 Total Cases 789 827 893 995 975 1006 1298 1090 1343 1283 Contraindications to Lung Transplantation Diabetes with End-Organ Dysfunction Immunologic Sensitization Severe Heart or Liver Disease Active Malignancy Psychosocial Deficiencies Substance Dependence Documented Medical Non-compliance Kidney Disease with GFR<40 Tobacco Use in previous 6 Months Advanced Age Symptomatic Vascular Disease Obesity History of Malignancy ADULT LUNG TRANSPLANTATION Kaplan-Meier Survival (Transplants: January 1994 - June 2006) 100 Double lung: 1/2-life = 6.2 Years; Conditional 1/2-life = 8.8 Years Single lung: 1/2-life = 4.5 Years; Conditional 1/2-life = 6.4 Years All lungs: 1/2-life = 5.2 Years; Conditional 1/2-life = 7.3 Years . 80 P < 0.0001 Survival (%) 60 40 Bilateral/Double Lung (N=10,064) Single Lung (N=9,384) All Lungs (N=19,448) 20 0 0 1 2 3 4 5 Years ISHLT 2008 J Heart Lung Transplant 2008;27: 937-983 6 7 8 9 10 Healthy vs. Diseased After Lung Transplant After Lung Transplant • ICU with Breathing Tube, sedated • When stable with good lung function Epidural Pain Control Wean Ventilator Bronchoscopy Deep Breathing and Coughing AMBULATION BREATHE / COUGH BRONCHOSCOPY I hope I haven’t put anyone to sleep! QUESTIONS?