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1 Focused Issue of This Month Treatment of Medically Intractable EndStage Heart Failure Jin Ho Choi, MD Department of Emergency Medicine, Sungkyunkwan University School of Medicine jinho.choi@samsung.com Eun Seok Jun, MD Department of Cardiology, Sungkyunkwan University School of Medicine esjeon@skku.edu J Korean Med Assoc 2008; 51(4): Abstract Heart failure is the final pathway for myriad diseases that affect the heart. Patients with refractory symptoms of heart failure despite ultimate medical therapy have very poor prognosis. In these patients, replacement of failing heart with permanent organ transplantation or ventricular assist device, which is temporarily or permanently implanted, is often lifesaving and can improve long term prognosis. Cardiac transplantation is the established standard for the treatment of endstage cardiac disease refractory to medical therapy. The clinical success of transplantation has been streadily improving with the refinement of recipient selection, better donor management, and better immunosuppressive agents. Recent substantial evolution of mechanical circulatory assist devices improved dramatically the outcome of not only patients in decompensated heart failure but also a large proportion of acute heart failure patients in cardiogenic shock. With this evolution, implantable sophisticated devices are being used as destination therapy as a substitute for transplantation and are expected to diminish the intrinsic shortage of donor compared to the epidemic of heart failure. Keywords : Endstage heart failure; Heart transplantation; Mechanical assist device 306

2 Treatment of Medically Intractable End Stage Heart Failure Table 1. Anticipated survival according to severity of advanced heart failure (adapted from Consensus Conference Report, J Am Coll Cardiol 2001; 37: 340). Disease entity Severity of Heart Failure Expected > 50% Mortality Cardiogenic shock Chronic heart failure with exacerbation into critical low output state Inhospital Acute myocardial infarction Postcardiotomy shock Chronic heart failure Dependent on intravenous inotropic therapy 3 ~6 months Class IV symptoms on oral therapy 12~24 months Refractory symptoms at rest or minimal exertion Less than 12 months Risk factors such as decreasing sodium, Less than 12 months increasing creatinine and/or blood urea nitrogen Stabilization as class III More than 24 months Heart failure Refractory ventricular arrhythmias Variable, not estimated Chronic severe posttransplant graft dysfunction with allograft vasculopathy Less than 12 months 307

3 Jun ES Choi JH Table 2. Indications and Contraindications for heart transplantation (adapted from Edwards NM ed, Cardiac Transplantation. The Columbia University Medical Center/New YorkPresbyterian Hospital Manual. Totowa, New Jersey: Humana Press, 2004). Indications VO 2 max < 10~14mg/kg/min NYHA class IV History of recurrent hospitalization for congestive heart failure Recurrent symptomatic ventricular arrhythmia Refractory ischemia without feasibility of revascularization and left ventricular Ejection fraction < 20~25% Contraindications Age > 65 year Active infection Active ulcer disease Severe diabetes mellitus with endorgan damage Severe peripheral vascular or cerebrovascular disease Coexisting neoplasm Morbid obesity Creatinine clearance < 40~50ml/min, effective renal plasma flow < 200ml/min Biliribin > 2.5mg/dl, transaminases > 2 normal Severe pulmonary dysfunction with FVC and FEV1 < 40% of predicted Especially with intrinsic lung disease Pulmonary artery systolic pressure > 60mmHg, Mean transpulmonary gradient > 15mmHg Pulmonary vascular resistance > 5 Wood units Active pulmonary thromboembolism Active diverticulitis 308

4 Treatment of Medically Intractable End Stage Heart Failure Table 3. Immunosuppressive agents after heart transplantation Classification Drugs Mechanism Steroid Prednisolone, Methylprednisolone Nonspecific anti inflammatory agent Inhibition of IL2 gene transcription Calcineurin inhibitor Cyclosporine Binds FKBP, inhibit IL 2 gene transcription Tacrolimus (Prograf) Azathioprine Inhibit purine metabolism Antiproliferative agents Mycophenolate mofetil (MMF, Cellcept) Inhibit purine metabolism Sirolimus, Everolimus Block IL2R downstream Polyclonal anti T cell Ab Anti T cell ATGAM, RATG, ATS Monoclonal anti T cell Ab Anti T cell Antibodies Anti CD3: OKT3 Anti IL2R: Daclizumab (Zenapax), Basiliximab (Simulect) Monoclonal anti B cell Ab Anti B cell Anti CD20: Rituximab (Rituxan, MabThera) 309

5 Jun ES Choi JH 310

6 Treatment of Medically Intractable End Stage Heart Failure Figure 1. Survival rates of heart failure (Adapted from Levy, N Engl J Med 2002; 347: ). 311

7 Jun ES Choi JH Oxygenator Femoral artery Centrifugal pump Femoral vein 7Fr 16Fr 20Fr Figure 2. Diagram of percutaneous cardiopulmonary support system (PCPS; EBS Capiox, Terumo, Japan). 312

Treatment of Medically Intractable End Stage Heart Failure Outflow conduit Outflow conduit Inflow conduit

sided pump A Pneumatic drive line B External battery pack Skin entry site Aorta Left ventricle To aorta

Percutaneous lead Percutaneous lead Rotor Blood flow Inlet stator and blood flow straightener C Figure 3.

8 Treatment of Medically Intractable End Stage Heart Failure Outflow conduit Outflow conduit Inflow conduit Inflow conduit Rt. sided pump Lt. sided pump A Pneumatic drive line B External battery pack Skin entry site Aorta Left ventricle To aorta Outlet stator and diffuser Motor Pump housing From left ventricle System controller Continuous flow LVAD Percutaneous lead Percutaneous lead Rotor Blood flow Inlet stator and blood flow straightener C Figure 3. Diagrams of ventricular assist device (A: Impella (Abiomed, USA), B: BiVAD, C: implantable continuous flow pump)(adapted from Miller, New Engl J Med 2007: 357; 9: ). 313

9 Jun ES Choi JH Figure 4. Scheme for selection of patients with acute cardiac disease or congestive heart failure for implantation of left ventricular assist devices (adapted from Rose, et al. N Engl J Med 2001; 345: ). 314

10 Treatment of Medically Intractable End Stage Heart Failure 11. Decline in deaths from heart disease and strokeunited States, 1900~1999. MMWR Morb Mortal Wkly Rep 1999; 48: Ford ES, Ajani UA, Croft JB, Critchley JA, Capewell S. Explaining the decrease in U.S. deaths from coronary disease, 1980~ N Engl J Med 2007; 356: Changes in mortality from heart failure United States, 1980~ MMWR Morb Mortal Wkly Rep 1998; 47: Levy D, Kenchaiah S, Larson MG, Vasan RS. Long term trends in the incidence of and survival with heart failure. N Engl J Med 2002; 347: Goldberg RJ, Ciampa J, Lessard D, Meyer TE, Spencer FA. Long term survival after heart failure: a contemporary populationbased perspective. Arch Intern Med 2007; 167: Lee MM, Oh BH, Park HS, Han SW, Ryu KH. Multicenter Analysis of Clinical Characteristics of the Patients with Congestive Heart Failure in Korea. Korean Circulation J 2003; 33: Swedberg K, Cleland J, Nieminen MS, Pierard L, Remme WJ. Guidelines for the diagnosis and treatment of chronic heart failure: executive summary (update 2005): The Task Force for the Diagnosis and Treatment of Chronic Heart Failure of the European Society of Cardiology. Eur Heart J 2005; 26: Lindenfield J, Miller GG, Shaker SF, Zolty R, Kobashigawa J. Drug therapy in the Heart transplant recipient Part I to part III. Circulation 2004; 110: , 2004; 110: and 2005; 111: Eisen HJ, Tuzcu EM, Dorent R, Bernhart P for the RAD study group. Everolimus for the prevention of allograft rejection and vasculopathy in cardiac transplant recipients. N Engl J Med 2003; 349: Beniaminovita A, Itescu S, Letz K, Mancini DM. Prevention of rejection in cardiac transplantation by blockade of the interleukin 2 receptor with a monoclonal antibody. N Engl J Med 2000; 342: Balfore IC, Fiore A, Graff RJ, Knutsen AP. Use of rituximab to decrease panelreactive antibodies. J Heart Lung Transplant 2005; 24: Taylor DO, Edwards LB, Boucek MM, Hertz MI. Registry of the International Society for Heart and Lung Transplantation: twentyfourth official adult heart transplant report J Heart Lung Transplant 2007; 26: Goldstein DJ, Oz MC, Rose EA. Implantable left ventricular assist devices. N Engl J Med 1998; 339: Stevenson LW, Kormos RL, Bourge RC, Gelijns A, Griffith BP, Wichman A. Mechanical cardiac support 2000: current applications and future trial design. June 15~16, 2000 Bethesda, Maryland. J Am Coll Cardiol 2001; 37: Maybaum S, Mancini D, Xydas S, Torre Amione G. Cardiac improvement during mechanical circulatory support: a prospective multicenter study of the LVAD Working Group. Circulation 2007; 115: Muller J, Wallukat G, Weng YG, Hetzer R. Weaning from mechanical cardiac support in patients with idiopathic dilated cardiomyopathy. Circulation 1997; 96: McCarthy RE, 3rd, Boehmer JP, Hruban RH, Hutchins GM, Kasper EK, Hare JM, Baughman KL. Long term outcome of fulminant myocarditis as compared with acute (nonfulminant) myocarditis. N Engl J Med 2000; 342: Seong IW, Choe SC, Jeon ES. Fulminant coxsackieviral myocarditis. N Engl J Med 2001; 345: Cooper LT, Jr, Berry GJ, Shabetai R. Idiopathic giant cell myocarditis natural history and treatment. Multicenter Giant Cell Myocarditis Study Group Investigators. N Engl J Med 1997; 336:

11 Jun ES Choi JH 20. Park JI, Jeon ES. Mechanical Circulatory Supports in the Treatment of Fulminant Myocarditis. Korean Circulation J. 2005; 35: Rhee I, Jeon ES. Giant Cell Myocarditis Manifested as Fulminant Myocarditis. Korean Circulatio J 2006; 36: Graner M, Lommi J, Kupari M, RaisanenSokolowski A, Toivonen L. Multiple forms of sustained monomorphic ventricular tachycardia as common presentation in giantcell myocarditis. Heart 2007; 93: Rose EA, Gelijns AC, Moskowitz AJ, Oz MC, Poirier VL. Longterm mechanical left ventricular assistance for end stage heart failure. N Engl J Med 2001; 345: Catanese KA, Goldstein DJ, Williams DL, Foray AT, Illick CD, Gardocki MT, Weinberg AD, Levin HR, Rose EA, Oz MC. Outpatient left ventricular assist device support: a destination rather than a bridge. Ann Thorac Surg 1996; 62: ; discussion Lietz K, Long JW, Kfoury AG, Miller LW. Outcomes of left ventricular assist device implantation as destination therapy in the postrematch era: implications for patient selection. Circulation 2007; 116: Miller LW, Pagani FD, Russell SD, John R, Farrar DJ, Frazier OH. Use of a continuousflow device in patients awaiting heart transplantation. N Engl J Med 2007; 357: Rhee I, Gwon HC, Choi J, Sung K, Lee YT, Kwon SU, Cho DK, Lim SH, Kim SW, Lee SH, Hong KP, Park JE. Percutaneous Cardiopulmonary Support for Emergency InHospital Cardiac Arrest or Cardiogenic Shock. Korean Circulation J 2006; 36: Sung K, Lee YT, Park PW, Park KH, Jun TG, Yang JH, Ha YK. Improved survival after cardiac arrest using emergent autopriming percutaneous cardiopulmonary support. Ann Thorac Surg 2006; 82: Peer Reviewers Commentary 316

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A 617 Special Issue Diabetic Retinopathy Won Ki Lee, M.D. Department of Ophthalmology The Catholic University of Korea College of Medicine Kangnam St. Mary s Hospital E mail : wklee@catholic.ac.kr Abstract R