clevelandclinic.org/transplant

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Esmond Webster
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1 LANE EBERHARDT HEART TRANSPLANT RECIPIENT I m running around like crazy now. Lane Eberhardt, 8, New Philadelphia, Ohio. Lane was born with severe aortic stenosis, a condition that worsened considerably in February Given just a few days to live, Lane received a BiVAD in May 2010 that saved his life and enabled him to gain much needed weight. In December 2010, Lane received his heart transplant. He and his family are looking forward to their first vacation together a trip to Hawaii in 2012.

2 CARDIAC TRANSPLANTATION Leadership 2010 Highlights Cleveland Clinic s Cardiac Transplant Program is a key component of the George M. and Linda H. Kaufman Center for Heart Failure. The clinical activity of the Cardiac Transplant Program remained robust in A total of 238 patients were formally evaluated for transplantation; 95 candidates were listed and 52 transplants were performed, of which five were heart/lung transplants. The program also continued to achieve excellent outcomes. The Scientific Registry of Transplant Recipients (SRTR) demonstrates that for patients receiving their first transplant between July 1, 2007, and Dec. 31, 2009, 92 percent of adult recipients were alive one year after transplant, compared with the expected 88 percent (based on the characteristics of recipients and donors, as well as on the experience of similar patients throughout the United States). For patients receiving their first transplant between Jan. 1, 2005, and June 30, 2007, the three-year survival rate for our program was 84 percent, compared with the 81 percent that was expected, based on national experience. These excellent results are testimony to the outstanding multidisciplinary care of our transplant program. Eiran Gorodeski, MD, MPH, and Guilherme H. Oliveira, MD, joined the Section of Heart Failure in Cardiovascular Medicine in Dr. Gorodeski specializes in cardiovascular epidemiology, cardiovascular risk modeling and heart failure outcomes. Dr. Oliveira specializes in cardiac oncology, cancer-related heart failure and chemotherapy-induced cardiomyopathy. Mechanical Circulatory Support The use of mechanical circulatory support for our end-stage heart failure population continues to grow. Fifty-two support devices were implanted in 51 patients at the Kaufman Center for Heart Failure. Of these, 28 were implanted as a bridge to transplant and 24 as destination therapy. Access to and expertise with mechanical support devices (Thoratec s Heartmate II, Syncardia s Total Artificial Heart and HeartWare ) allow us to utilize the optimal device for each individual patient. Randall Starling, MD, MPH Program and Medical Director, Heart Transplant Program; Vice Chairman, Department of Cardiovascular Diseases; Section Head, Heart Failure and Cardiac Transplant Medicine; Medical Director, Kaufman Center for Heart Failure Nicholas Smedira, MD Program and Surgical Director, Heart Transplant Program and Kaufman Center for Heart Failure; Polly and W. Neil Rossborough Chair in Cardiac Transplantation CARDIAC TRANSPLANTATION 32 33

3 Fast facts Initiated: 1984 First adult heart transplant: Aug. 15, 1984 UNOS approval: March 21, 1988 Medicare approval: June 13, 1988 As of Dec. 31, 2010, 1,521 heart transplants have been performed at Cleveland Clinic. Cleveland Clinic developed and tested temporary and permanent artificial heart devices. In 2005, Cleveland Clinic was the first in America to implant the CardioWest Total Artificial Heart after its approval by the FDA. The Total Artificial Heart can provide a bridge to transplantation for patients who are at risk of imminent death from nonreversible biventricular failure. Pediatric patient Lane Eberhardt, featured on page 32, was diagnosed as an infant with a severe aortic stenosis, a heart valve defect that prevents complete blood flow from the heart s left ventricle to the rest of the body. In February 2010, he experienced trouble breathing and showed other signs of heart failure. By May, he had deteriorated so much that his cardiologists recommended a ventricular assist device. Now, the 8-year-old New Philadelphia resident is only the third patient in Ohio to receive the EXCOR Pediatric implant. Manufactured by Berlin Heart GmbH, the device supported the function of Lane s diseased heart until he was transplanted with a donor heart in December. Research and Innovations The cardiac transplant and heart failure program continues to participate in many clinical research studies. Three important trials concluded in The goals of these trials were to manage acute heart failure, improve long-term survival, minimize postoperative morbidity in the transplant population, and evaluate the safety and effectiveness of mechanical circulatory support as a bridge to transplant. Principal Investigator Dr. Randall Starling Double-blind, placebo-controlled, multicenter acute study of clinical effectiveness of nesiritide in subjects with decompensated heart failure. ASCEND-HF randomized 7,141 patients in 30 countries (including 45 percent from North America) in double-blind fashion and within 24 hours of hospitalization and institution of acute IV therapy for acute decompensated heart failure (ADHF) to receive IV nesiritide or placebo on top of standard therapy. Researchers concluded that the IV vasodilator nesiritide (Natrecor, Scios/Johnson & Johnson) doesn t compromise renal function or increase mortality within a month of its use in ADHF. Nor, of note, does it have much more of an effect against acute dyspnea than can be currently achieved in ADHF with conventional diuretics and vasodilators, both of which are less expensive than nesiritide, a mass-production version of a native natriuretic peptide. The trial results were presented at the American Heart Association 2010 Scientific Sessions. Principal Investigator Dr. Randall Starling The Invasive Monitoring Attenuation Through Gene Expression (IMAGE) trial reported that in low-risk cardiac-transplant recipients, a blood assay for rejection-related gene expression is at least as effective a way to monitor for rejection episodes as a strategy of routine endomyocardial biopsy. Patients followed with the AlloMap gene-expression profiling test (XDx, Brisbane, Calif.) who primarily underwent biopsy when indicated clinically, echocardiographically

4 or by the test itself suffered significantly fewer of the invasive procedures than did those who underwent biopsy as the main surveillance method. The gene-expression test had been validated as a reflection of endomyocardial biopsy results in the multicenter CARGO study; it was approved by the FDA in August The group s report on the IMAGE trial was published online April 22, 2010, in the New England Journal of Medicine and presented at the International Society for Heart & Lung Transplantation Principal Investigator Dr. Nicholas G. Smedira HeartWare, an LVAD, has proven to be a viable alternative to the only other widely used LVAD, Thoratec s HeartMate II, as a bridge to heart transplant. The findings were presented at the American Heart Association s 2010 Scientific Sessions. Phone number Children s Hospital First pediatric heart transplant: March 30, 1985 Four pediatric heart transplants were performed in Survival analysis: For patients receiving their first transplant of this type between July 1, 2007, and Dec. 31, 2009, and for the one-month and one-year models; between Jan. 1, 2005, and June 30, 2007, for the three-year model. Single-organ transplants only; re-transplants excluded. (Source: Scientific Registry of Transplant Recipients, January 2011.) Adult survival 1 month 1 year 3 years Patient survival percent CARDIAC TRANSPLANTATION Pediatric survival 1 month 1 year 3 years Patient survival percent

5 Number of transplants Heart Only Heart/Lung Heart/Kidney Heart/Liver Total* * Includes re-transplants. Number of transplants Heart Only Heart/Lung Heart/Kidney Heart/Liver , Total 1,521 Days on waiting list and post-transplant length of stay (LOS) for patients transplanted in 2010 Mean Median Number Days waiting Post-transplant LOS UNOS status of patients transplanted in 2010 Status Frequency Percent 1A B

6 Primary diagnoses for patients transplanted in 2010 Diagnosis Number Percent Coronary artery disease Dilated cardiomyopathy Congenital heart defect with surgery Viral cardiomyopathy Hypertrophic cardiomyopathy Postpartum cardiomyopathy Valvular heart disease Other Total 52 Heart transplant mortality 2010 Hospital deaths (within 30 days post-transplant) 0 CARDIAC TRANSPLANTATION 36 37

7 Selected Publications Gorodeski EZ, Chu EC, Chow CH, Levy WC, Hsich E, Starling RC. Application of the Seattle Heart Failure Model in ambulatory patients presented to an advanced heart failure therapeutics committee. Circ Heart Fail Nov 1;3(6): Mehra MR, Crespo-Leiro MG, Dipchand A, Ensminger SM, Hiemann NE, Kobashigawa JA, Madsen J, Parameshwar J, Starling RC, Uber PA. International Society for Heart and Lung Transplantation working formulation of a standardized nomenclature for cardiac allograft vasculopathy J Heart Lung Transplant Jul;29(7): Cantillon DJ, Tarakji KG, Hu T, Hsu A, Smedira NG, Starling RC, Wilkoff BL, Saliba WI. Long-term outcomes and clinical predictors for pacemaker-requiring bradyarrhythmias after cardiac transplantation: analysis of the UNOS/OPTN cardiac transplant database. Heart Rhythm Nov;7(11): Pham MX, Teuteberg JJ, Kfoury AG, Starling RC, Deng MC, Cappola TP, Kao A, Anderson AS, Cotts WG, Ewald GA, Baran DA, Bogaev RC, Elashoff B, Baron H, Yee J, Valantine HA; IMAGE Study Group. Gene-expression profiling for rejection surveillance after cardiac transplantation. N Engl J Med May 20;362(20): Smedira NG, Hoercher KJ, Yoon DY, Rajeswaran J, Klingman L, Starling RC, Blackstone EH. Bridge to transplant experience: factors influencing survival to and after cardiac transplant. J Thorac Cardiovasc Surg May;139(5): , 1305.e1-4. Ogletree ML, Sweet WE, Talerico C, Klecka ME, Young JB, Smedira NG, Starling RC, Moravec CS. Duration of left ventricular assist device support: effects on abnormal calcium cycling and functional recovery in the failing human heart. J Heart Lung Transplant May;29(5): Yoon DY, Smedira NG, Nowicki ER, Hoercher KJ, Rajeswaran J, Blackstone EH, Lytle BW. Decision support in surgical management of ischemic cardiomyopathy. J Thorac Cardiovasc Surg Feb;139(2): Cantillon DJ, Gorodeski EZ, Caccamo M, Smedira NG, Wilkoff BL, Starling RC, Saliba W. Long-term outcomes and clinical predictors for pacing after cardiac transplantation. J Heart Lung Transplant Aug;28(8):791-8.

8 Staff Eugene Blackstone, MD Corinne Bott-Silverman, MD Gerard J. Boyle, MD Gonzalo V. Gonzalez-Stawinski, MD Eiran Gorodeski, MD, MPH Mazen A. Hanna, MD Robert Hobbs, MD Eileen Hsich, MD Karen James, MD Constantine Mavroudis, MD Tomislav Mihaljevic, MD Christine Moravec, PhD Maria Mountis, DO Guilherme H. Oliveira, MD Gustavo Rincon, MD Rene Rodriguez, MD Edward Soltesz, MD CARDIAC TRANSPLANTATION Robert Stewart, MD, MPH Carmela Tan, MD W.H. Wilson Tang MD, FACC, FAHA David Taylor, MD James Young, MD 38 39

Populations Interventions Comparators Outcomes Individuals: With heart transplant

Populations Interventions Comparators Outcomes Individuals: With heart transplant Protocol Laboratory Tests for Heart Transplant Rejection (20168) Medical Benefit Effective Date: 07/01/14 Next Review Date: 05/18 Preauthorization No Review Dates: 05/13, 05/14, 05/15, 05/16, 05/17 This