Prospective observational study on predicting adverse clinical outcomes in patients with implanted defibrillating devices – a study rationale, design and principal methods
DOI:
https://doi.org/10.20883/medical.e50Keywords:
cardiac resynchronization therapy, implantable cardioverter-defibrillator, risk prediction, sudden cardiac death, ventricular arrhythmiaAbstract
The project “Predicting adverse clinical outcomes in patients with implanted defibrillating devices” is a prospective observational study in a group of high risk cardiac patients with already implanted either an implantable cardioverter-defibrillator (ICD) or a cardiac resynchronization therapy device with defibrillating mode (CRT-D). The primary project aim is to build predictive models for an appropriate ICD or CRT-D interventions and other adverse clinical outcomes based on clinical assessment of the cardiovascular system, general clinical status, advanced mathematical and statistical analysis of cardiovascular time series and biological signals, including pressure waveforms, ECG and cardiac impedance. Up to 600 ambulatory adult patients are scheduled to be enrolled and after the first visit they are expected to be followed-up every 6 months for a number of clinical outcomes, including antiarrhythmic therapy intervention, sudden and aborted cardiac death and total mortality. The project launched in March 2010 and is expected to end in February 2014.Downloads
References
Zipes DP1, Camm AJ, Borggrefe M, Buxton AE, Chaitman B, Fromer M et al. American College of Cardiology; American Heart Association Task Force; European Society of Cardiology Committee for Practice Guidelines; European Heart Rhythm Association; Heart Rhythm Society. ACC/AHA/ESC 2006 guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death: a report of the American College of Cardiology/American Heart Association Task Force and the European Society of Cardiology Committee for Practice Guidelines (Writing Committee to Develop guidelines for management of patients with ventricular arrhythmias and the prevention of sudden cardiac death) developed in collaboration with the European Heart Rhythm Association and the Heart Rhythm Society. Europace. 2006;8:746–837.
Dickstein K, Vardas PE, Auricchio A, Daubert JC, Linde C, McMurray J et al. ESC Committee for Practice Guidelines (CPG). 2010 Focused Update of ESC Guidelines on device therapy in heart failure: an update of the. 2008 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure and the. 2007 ESC guidelines for cardiac and resynchronization therapy. Developed with the special contribution of the Heart Failure Association and the European Heart Rhythm Association. Eur Heart J. 2010;31:2677–87.
Brignole M, Auricchio A, Baron-Esquivias G, Bordachar P, Boriani G, Breithardt OA et al. 2013 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy: the Task Force on cardiac pacing and resynchronization therapy of the European Society of Cardiology (ESC). Developed in collaboration with the European Heart Rhythm Association (EHRA). Eur Heart J. 2013;34:2281–2329.
Salukhe T, Dimopoulos K, Sutton R, Coats A, Piepoli M, Francis D. Life-years gained from defibrillator implantation: markedly non-linear increase during 3 years of follow-up and its implications. Circulation. 2004;109: 1848–53.
Camm J, Klein H, Nisam S. The cost of implantable defibrillators: perceptions and reality. Eur Heart J. 2007;28:392–7.
Tung R, Zimetbaum P, Josephson ME. A critical appraisal of implantable cardioverter-defibrillator therapy for the prevention of sudden cardiac death J Am Coll Cardiol. 2008;52:1111–21.
Rasekaba T, Lee AL, Naughton MT, Williams TJ, Holland AE. The six-minute walk test: a useful metric for the cardiopulmonary patient. Intern Med J. 2009;39:495–501.
Cavalcante JL, Lima JA, Redheuil A, Al-Mallah MH. Aortic stiffness: current understanding and future directions. J Am Coll Cardiol. 2011;57:1511–22.
Nagueh SF, Appleton CP, Gillebert TC, Marino PN, Oh JK, Smiseth OA et al. Recommendations for the evaluation of left ventricular diastolic function by echocardiography. Eur J Echocardiogr. 2009;10:165–93.
Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Joint ESC/ACCF/AHA/WHF Task Force for Universal Definition of Myocardial Infarction. Third universal definition of myocardial infarction. J Am Coll Cardiol. 2012;60:1581–98.
Lang RM, Bierig M, Devereux RB, Flachskampf FA, Foster E, Pellikka PA et al. American Society of Echocardiography's Nomenclature and Standards Committee; Task Force on Chamber Quantification; American College of Cardiology Echocardiography Committee; American Heart Association; European Association of Echocardiography, European Society of Cardiology. Recommendations for chamber quantification. Eur J Echocardiogr. 2006;7:79–108.
Jiamsripong P, Honda T, Reuss CS, Hurst RT, Chaliki HP, Grill DE et al. Three methods for evaluation of left atrial volume. Eur J Echocardiogr. 2008;9:351–5.
Wykretowicz A, Gerstenberger P, Guzik P, Milewska A, Krauze T, Adamska K et al. Arterial stiffness in relation to subclinical atherosclerosis. Eur J Clin Invest. 2009;39:11–6.
Douglas PS. The left atrium: a biomarker of chronic diastolic dysfunction and cardiovascular disease risk. J Am Coll Cardiol. 2003;42:1206–7.
Fieselmann JF, Hendryx MS, Helms CM, Wakefield DS. Respiratory rate predicts cardiopulmonary arrest for internal medicine patients, J Gen Intern Med. 1993;8:354–60.
Bauer A, Guzik P, Barthel P, Schneider R, Watanabe MA, Schmidt G. Reduced prognostic power of ventricular late potentials in post-infarction patients of the reperfusion era. Eur Heart J. 2005; 26: 755–61.
Bauer A, Malik M, Schmidt G, Barthel P, Bonnemeier H, Cygankiewicz I et al. Heart rate turbulence: standards of measurement, physiological interpretation, and clinical use: International Society for Holter and Noninvasive Electrophysiology Consensus. J Am Coll Cardiol. 2008;52:1353–65.
Guzik P, Piskorski J, Krauze T, Wykretowicz A, Wysocki H. Heart rate asymmetry by Poincaré plots of RR intervals. Biomed Tech (Berl). 2006;51:272–5.
Piskorski J, Guzik P. Geometry of the Poincaré plot of RR intervals and its asymmetry in healthy adults. Physiol Meas. 2007;28:287–300.
Guzik P, Piskorski J, Krauze T, Wykretowicz A, Wysocki H. Partitioning total heart rate variability. Int J Cardiol. 2010;144: 138–9.
Guzik P, Rogacka D, Tarchalski J, Minczykowski A, Baliński M, Wykrętowicz A et al. Comparison of the exercise treadmill test and 24-hour ECG Holter monitoring in patients with syndrome X or coronary atherosclerosis. Kard Pol. 2007;3:262–9.
Katarzynska-Szymanska A, Ochotny R, Oko-Sarnowska Z, Wachowiak-Baszynska H, Krauze T, Piskorski J et al. Shortening baroreflex delay in hypertrophic cardiomyopathy patients – an unknown effect of ß-blockers. Br J Clin Pharmacol. 2013;75:1516–24.
Piskorski J, Guzik P. Compensatory properties of heart rate asymmetry. J Electrocardiol. 2012;45:220–4.
Piskorski J, Guzik P. Asymmetric properties of long-term and total heart rate variability. Med Biol Eng Comput. 2011;49:1289–97.
Guzik P, Piskorski J, Barthel P, Bauer A, Müller A, Junk N et al. Heart rate deceleration runs for postinfarction risk prediction. J Electrocardiol. 2012;45:70–6.
Piskorski J, Guzik P. The structure of heart rate asymmetry: deceleration and acceleration runs. Physiol Meas. 2011;32:1011–23.
Guzik P, Piskorski J, Krauze T, Narkiewicz K, Wykretowicz A, Wysocki H. Asymmetric features of short-term blood pressure variability. Hypertens Res. 2010;33:1199–1205.
Januzzi JL Jr, Rehman SU, Mohammed AA, Bhardwaj A, Barajas L, Barajas J et al. Use of amino-terminal pro-B-type natriuretic peptide to guide outpatient therapy of patients with chronic left ventricular systolic dysfunction. J Am Coll Cardiol. 2011;58: 1881–89.
Scott PA, Barry J, Roberts PR, Morgan JM. Brain natriuretic peptide for the prediction of sudden cardiac death and ventricular arrhythmias: a meta-analysis. Eur J Heart Fail. 2009;11:958–66.
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