Remote noninvasive allograft rejection monitoring for heart transplant recipients: study protocol for the novel evaluation with home electrocardiogram and remote transmission (NEW HEART) study

BMC Cardiovascular Disorders

Barbara J Drew²  Belinda Chen¹  David Pickham²  Kathleen Hickey³  Lynn V Doering⁴ 

[1]University of California, Los Angeles (UCLA), School of Nursing 700 Tiverton Ave. Factor Building 4-266, Los Angeles, Ca 90095, USA

[2]University of California, San Francisco (UCSF), 2 Koret Way, N611H, San Francisco, CA 94143-0610, USA

[3]Columbia University, School of Nursing, 630 West 168th Street, New York, NY 10032, USA

[4]University of California, Los Angeles (UCLA), School of Nursing, 700 Tiverton Ave., Factor Building 4-266, Los Angeles, Ca 90095, USA

关键词: Allograft rejection;    Heart transplantation;    QT interval;    ECG monitoring;   

Others  :  1085242
DOI  :  10.1186/1471-2261-12-14

 received in 2012-01-11, accepted in 2012-03-02,  发布年份 2012

【 摘 要 】

Background

Acute allograft rejection is a major cause of early mortality in the first year after heart transplantation in adults. Although endomyocardial biopsy (EMB) is not a perfect "gold standard" for a correct diagnosis of acute allograft rejection, it is considered the best available test and thus, is the current standard practice. Unfortunately, EMB is an invasive and costly procedure that is not without risk. Recent evidence suggests that acute allograft rejection causes delays in ventricular repolarization and thereby increases the cellular action potential duration resulting in a longer QT interval on the electrocardiogram (ECG). No prospective study to date has investigated whether such increases in the QT interval could provide early detection of acute allograft rejection. Therefore, in the Novel Evaluation With Home Electrocardiogram And Remote Transmission (NEW HEART) study, we plan to investigate the potential benefit of daily home QT interval monitoring to predict acute allograft rejection.

Methods/design

The NEW HEART study is a prospective, double-blind, multi-center descriptive research study. A sample of 325 adult heart transplant recipients will be recruited within six weeks of transplant from three sites in the United States. Subjects will receive the HeartView™ ECG recorder and its companion Internet Transmitter, which will transmit the subject's ECG to a Core Laboratory. Subjects will be instructed to record and transmit an ECG recording daily for 6 months. An increase in the QT_C interval from the previous day of at least 25 ms that persists for 3 consecutive days will be considered abnormal. The number and grade of acute allograft rejection episodes, as well as all-cause mortality, will be collected for one year following transplant surgery.

Discussion

This study will provide "real world" prospective data to determine the sensitivity and specificity of QT_C as an early non invasive marker of cellular rejection in transplant recipients during the first post-transplant year. A non-invasive indicator of early allograft rejection in heart transplant recipients has the potential to limit the number and severity of rejection episodes by reducing the time and cost of rejection surveillance and by shortening the time to recognition of rejection.

Trial Registration

ClinicalTrials.gov: NCT01365806

【 授权许可】

   
2012 Doering et al; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

【 参考文献 】

• [1]The Organ Procurement and Transplantation Network [http://optn.transplant.hrsa.gov/data/] webcite
• [2]Stehlik J, Edwards LB, Kucheryavaya AY, Benden C, Christie JD, Dobbels F, Kirk R, Rahmel AO, Hertz MI: The Registry of the International Society for Heart and Lung Transplantation: Twenty-eighth adult heart transplant report - 2011. The Journal of Heart and Lung Transplantation 2011, 30(10):1078-1094.
• [3]Jalowiec A, Grady KL, White-Williams C: Predictors of rehospitalization time during the first year after heart transplant. Heart Lung 2008, 37(5):344-355.
• [4]Fiorelli AI, Coelho GHB, Oliveira JL Jr, Aiello VD, Benvenuti LA, Santos A, Chi A, Tallans A, Igushi ML, Bacal F, et al.: Endomyocardial Biopsy as Risk Factor in the Development of Tricuspid Insufficiency After Heart Transplantation. Transplant Proc 2009, 41(3):935-937.
• [5]Hamour IM, Burke MM, Bell AD, Panicker MG, Banerjee R, Banner NR: Limited Utility of Endomyocardial Biopsy in the First Year after Heart Transplantation. Transplantation 2008, 85(7):969-974.
• [6]Pham MX, Teuteberg JJ, Kfoury AG, Starling RC, Deng MC, Cappola TP, Kao A, Anderson AS, Cotts WG, Ewald GA, et al.: Gene-Expression Profiling for Rejection Surveillance after Cardiac Transplantation. N Engl J Med 2010, 362(20):1890-1900.
• [7]Jarcho JA: Fear of Rejection - Monitoring the Heart-Transplant Recipient. N Engl J Med 2010, 362(20):1932-1933.
• [8]Richartz BM, Radovancevic B, Bologna MT, Frazier OH: Usefulness of the QTc interval in predicting acute allograft rejection. Thorac Cardiovasc Surg 1998, 46(4):217-221.
• [9]Kolasa MW, Lee JC, Atwood JE, Marcus RR, Eckart RE: Relation of QTc duration heterogeneity to mortality following orthotopic heart transplantation. Am J Cardiol 2005, 95(3):431-432.
• [10]Tenderich G, Jahanyar J, Zittermann A, Schleithoff SS, Wlost S, Korfer R: Predictive value of ECG changes for acute cardiac rejections in heart transplant recipients. Med Klin (Munich) 2006, 101(2):99-106.
• [11]Vrtovec B, Radovancevic R, Thomas CD, Yazdabakhsh AP, Smart FW, Radovancevic B: Prognostic value of the QTc interval after cardiac transplantation. J Heart Lung Transplant 2006, 25(1):29-35.
• [12]Vrtovec B, Haddad F, Tsai V, Al-Ahmad A, Cause T, Pham M, Fisher P, Fearon W, Valentine H, Hunt S: QT Interval Prolongation during Severe Acute Rejection is Predictive of Sudden Cardiac Death in Heart Transplant Recipients. Circulation 2008, 118(18):S801-S801.
• [13]Überfuhr P, Frey AW, Ziegler S, Reichart B, Schwaiger M: Sympathetic reinnervation of sinus node and left ventricle after heart transplantation in humans: regional differences assessed by heart rate variability and positron emission tomography. The Journal of Heart and Lung Transplantation 2000, 19(4):317-323.
• [14]Diagnostic electrocardiographic devices In American National Standard. second edition. Arlington: Association for the Advancement of Medical Instrumentation; 2001. Edited by ANSI/AAMI, vol. EC11-1991 (R)
• [15]ARIZONA CERT Center for Education and Research on Therapeutics
• [16]Drew BJ, Ackerman MJ, Funk M, Gibler WB, Kligfield P, Menon V, Philippides GJ, Roden DM, Zareba W, The American Heart Association Acute Cardiac Care Committee of the Council on Clinical Cardiology tCoCN, et al.: Prevention of Torsade de Pointes in Hospital Settings: A Scientific Statement From the American Heart Association and the American College of Cardiology Foundation. Circulation 2010, 121(8):1047-1060.
• [17]Babuty D, Aupart M, Cosnay P, Sirinelli A, Rouchet S, Marchand M, Fauchier JP: Electrocardiographic and electrophysiologic properties of cardiac allografts. J Cardiovasc Electrophysiol 1994, 5(12):1053-1063.
• [18]Postema PG, De Jong JS, Van der Bilt IA, Wilde AA: Accurate electrocardiographic assessment of the QT interval: teach the tangent. Hear Rhythm 2008, 5(7):1015-1018.
• [19]Topilski I, Rogowski O, Rosso R, Justo D, Copperman Y, Glikson M, Belhassen B, Hochenberg M, Viskin S: The morphology of the QT interval predicts torsade de pointes during acquired bradyarrhythmias. J Am Coll Cardiol 2007, 49(3):320-328.
• [20]Antzelevitch C, Shimizu W: Cellular mechanisms underlying the long QT syndrome. Curr Opin Cardiol 2002, 17(1):43-51.
• [21]Akar FG, Yan GX, Antzelevitch C, Rosenbaum DS: Unique topographical distribution of M cells underlies reentrant mechanism of torsade de pointes in the long-QT syndrome. Circulation 2002, 105(10):1247-1253.
• [22]Winters GL, McManus BM: Consistencies and controversies in the application of the International Society for Heart and Lung Transplantation working formulation for heart transplant biopsy specimens. Rapamycin Cardiac Rejection Treatment Trial Pathologists J Heart Lung Transplant 1996, 15(7):728-735.
• [23]Yang HM, Lai CK, Gjertson DW, Baruch-Oren T, Ra SH, Watts W, Wallace WD, Shintaku P, Kobashigawa JA, Fishbein MC: Has the 2004 revision of the International Society of Heart and Lung Transplantation grading system improved the reproducibility of the diagnosis and grading of cardiac transplant rejection? Cardiovasc Pathol 2009, 18(4):198-204.
• [24]Marboe CC, Billingham M, Eisen H, Deng MC, Baron H, Mehra M, Hunt S, Wohlgemuth J, Mahmood I, Prentice J, et al.: Nodular endocardial infiltrates (Quilty lesions) cause significant variability in diagnosis of ISHLT Grade 2 and 3A rejection in cardiac allograft recipients. J Heart Lung Transplant 2005, 24(7 Suppl):S219-S226.
• [25]REDCap [http://www.project-redcap.org/] webcite
• [26]Chen JM: "Take Another Little Piece of My Heart Now": Should Endomyocardial Biopsy Remain the Gold Standard? [Editorial]. Transplantation 2008, 85(7):934.