Determining the prevalence and predictors of sleep disordered breathing in patients with chronic heart failure: rationale and design of the SCHLA-HF registry

Holger Woehrle, Olaf Oldenburg, Michael Arzt, Andrea Graml, Erland Erdmann, Helmut Teschler, Karl Wegscheider, SCHLA-HF Investigators, Holger Woehrle, Olaf Oldenburg, Michael Arzt, Andrea Graml, Erland Erdmann, Helmut Teschler, Karl Wegscheider, SCHLA-HF Investigators

Abstract

Background: The objective of the SCHLA-HF registry is to investigate the prevalence of sleep-disordered breathing (SDB) in patients with chronic heart failure with reduced left ventricular systolic function (HF-REF) and to determine predictors of SDB in such patients.

Methods: Cardiologists in private practices and in hospitals in Germany are asked to document patients with HF-REF into the prospective SCHLA-HF registry if they meet predefined inclusion and exclusion criteria. Screening was started in October 2007 and enrolment was completed at the end of May 2013. After enrolment in the registry, patients are screened for SDB. SDB screening is mainly undertaken using the validated 2-channel ApneaLink™ device (nasal flow and pulse oximetry; ResMed Ltd., Sydney, Australia). Patients with a significant number of apneas and hypopneas per hour recording time (AHI ≥15/h) and/or clinical symptoms suspicious of SDB will be referred to a cooperating sleep clinic for an attended in-lab polysomnography with certified scoring where the definite diagnosis and, if applicable, the differentiation between obstructive and central sleep apnea will be made. Suggested treatment will be documented.

Discussion: Registries play an important role in facilitating advances in the understanding and management of cardiovascular disease. The SCHLA-HF registry will provide consistent data on a large group of patients with HF-REF that will help to answer questions on the prevalence, risk factors, gender differences and stability of SDB in these patients by cross-sectional analyses. Further insight into the development of SDB will be gained by extension of the registry to include longitudinal data.

Figures

Figure 1
Figure 1
Patient flow and populations in the SCHLA-HF registry. AHI, apnea-hypopnea index; BMI, body mass index; LVEF, left ventricular ejection fraction; NYHA, New York Heart Association; PG, polygraphy; PSG, polysomnography; SDB, sleep-disordered breathing.

References

    1. Mosterd A, Hoes AW. Clinical epidemiology of heart failure. Heart. 2007;93:1137–1146. doi: 10.1136/hrt.2003.025270.
    1. Hogg K, Swedberg K, McMurray J. Heart failure with preserved left ventricular systolic function; epidemiology, clinical characteristics, and prognosis. J Am Coll Cardiol. 2004;43:317–327. doi: 10.1016/j.jacc.2003.07.046.
    1. McMurray JJ, Adamopoulos S, Anker SD, Auricchio A, Böhm M, Dickstein K, Falk V, Filippatos G, Fonseca C, Gomez-Sanchez MA, Jaarsma T, Køber L, Lip GY, Maggioni AP, Parkhomenko A, Pieske BM, Popescu BA, Rønnevik PK, Rutten FH, Schwitter J, Seferovic P, Stepinska J, Trindade PT, Voors AA, Zannad F, Zeiher A, Bax JJ, Baumgartner H, Ceconi C. ESC Committee for Practice Guidelines (CPG) ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure 2012: The Task Force for the Diagnosis and Treatment of Acute and Chronic Heart Failure 2012 of the European Society of Cardiology. Developed in collaboration with the Heart Failure Association (HFA) of the ESC. Eur Heart J. 2012;33:1787–1847.
    1. Bhatia RS, Tu JV, Lee DS, Austin PC, Fang J, Haouzi A, Gong Y, Liu PP. Outcome of heart failure with preserved ejection fraction in a population-based study. N Engl J Med. 2006;355:260–269. doi: 10.1056/NEJMoa051530.
    1. Bitter T, Faber L, Hering D, Langer C, Horstkotte D, Oldenburg O. Sleep-disordered breathing in heart failure with normal left ventricular ejection fraction. Eur J Heart Fail. 2009;11:602–608. doi: 10.1093/eurjhf/hfp057.
    1. Oldenburg O, Lamp B, Faber L, Teschler H, Horstkotte D, Topfer V. Sleep-disordered breathing in patients with symptomatic heart failure: a contemporary study of prevalence in and characteristics of 700 patients. Eur J Heart Fail. 2007;9:251–257. doi: 10.1016/j.ejheart.2006.08.003.
    1. Herrscher TE, Akre H, Øverland B, Sandvik L, Westheim AS. High prevalence of sleep apnea in heart failure outpatients: even in patients with preserved systolic function. J Card Fail. 2011;17:420–425. doi: 10.1016/j.cardfail.2011.01.013.
    1. Shahar E, Whitney CW, Redline S, Lee ET, Newman AB, Javier Nieto F, O'Connor GT, Boland LL, Schwartz JE, Samet JM. Sleep-disordered breathing and cardiovascular disease: cross-sectional results of the Sleep Heart Health Study. Am J Respir Crit Care Med. 2001;163:19–25. doi: 10.1164/ajrccm.163.1.2001008.
    1. Gottlieb DJ, Yenokyan G, Newman AB, O’Connor GT, Punjabi NM, Quan SF, Redline S, Resnick HE, Tong EK, Diener-West M, Shahar E. A prospective study of obstructive sleep apnea and incidence coronary heart disease and heart failure: the sleep health heart study. Circulation. 2010;122:352–360. doi: 10.1161/CIRCULATIONAHA.109.901801.
    1. Carmona-Bernal C, Ruiz-Garcia A, Villa-Gil M, Villa-Gil M, Sánchez-Armengol A, Quintana-Gallego E, Ortega-Ruiz F, Barón-Esquivias G, Capote F. Quality of life in patients with heart failure and central sleep apnea. Sleep Med. 2008;9:646–651. doi: 10.1016/j.sleep.2007.11.008.
    1. Lanfranchi PA, Somers VK, Braghiroli A, Corra U, Eleuteri E, Giannuzzi P. Central sleep apnea in left ventricular dysfunction: prevalence and implications for arrhythmic risk. Circulation. 2003;107:727–732. doi: 10.1161/.
    1. Oldenburg O, Schmidt A, Lamp B, Bitter T, Muntean BG, Langer C, Horstkotte D. Adaptive servoventilation improves cardiac function in patients with chronic heart failure and Cheyne-Stokes respiration. Eur J Heart Fail. 2008;10:581–586. doi: 10.1016/j.ejheart.2008.04.007.
    1. Solin P, Bergin P, Richardson M, Kaye DM, Walters EH, Naughton MT. Influence of pulmonary capillary wedge pressure on central apnea in heart failure. Circulation. 1999;99:1574–1579. doi: 10.1161/01.CIR.99.12.1574.
    1. Jilek C, Krenn M, Sebah D, Obermeier R, Braune A, Kehl V, Schroll S, Montalvan S, Riegger GA, Pfeifer M, Arzt M. Prognostic impact of sleep disordered breathing and its treatment in heart failure: an observational study. Eur J Heart Fail. 2011;13:68–75. doi: 10.1093/eurjhf/hfq183.
    1. Wang H, Parker JD, Newton GE, Floras JS, Mak S, Chiu KL, Ruttanaumpawan P, Tomlinson G, Bradley TD. Influence of obstructive sleep apnea on mortality in patients with heart failure. J Am Coll Cardiol. 2007;49:1625–1631. doi: 10.1016/j.jacc.2006.12.046.
    1. Javaheri S, Shukla R, Zeigler H, Wexler L. Central sleep apnea, right ventricular dysfunction, and low diastolic blood pressure are predictors of mortality in systolic heart failure. J Am Coll Cardiol. 2007;49:2028–2034. doi: 10.1016/j.jacc.2007.01.084.
    1. Khayat R, Abraham W, Patt B, Brinkman V, Wannemacher J, Porter K, Jarjoura D. Central sleep apnea is a predictor of cardiac readmission in hospitalized patients with systolic heart failure. J Card Fail. 2012;18:534–540. doi: 10.1016/j.cardfail.2012.05.003.
    1. Oldenburg O, Bitter T, Vogt J, Fischbach T, Dimitriadis Z, Bullert K, Horstkotte D. Central and obstructive sleep apnea are associated with increased mortality in patients with long-term cardiac resynchronization therapy. J Am Coll Cardiol. 2011;54(Suppl. A):E100.
    1. Gitt AK, Bueno H, Danchin N, Fox K, Hochadel M, Kearney P, Maggioni AP, Opolski G, Seabra-Gomes R, Weidinger F. The role of cardiac registries in evidence-based medicine. Eur Heart J. 2010;31:525–529. doi: 10.1093/eurheartj/ehp596.
    1. Krumholz HM. Registries and selection bias. The need for accountability. Circ Cardiovasc Qual Outcomes. 2009;2:517–518. doi: 10.1161/CIRCOUTCOMES.109.916601.
    1. Gliklich RE, Dreyer NA, editor. (Prepared by Outcome DEcIDE Center [Outcome Sciences, Inc. dba Outcome] under Contract No. HHSA29020050035ITO1.) AHRQ Publication No. 07-EHC001-1. Rockville, MD: Agency for Healthcare Research and Quality; 2007. Registries for Evaluating Patient Outcomes: A User’s Guide.
    1. Cowie MR, Woehrle H, Wegscheider K, Angermann C, D’Ortho M-P, Erdmann E, Levy P, Simonds A, Somers VK, Zannad F, Teschler H. Rationale and design of the SERVE-HF study: adaptive servo-ventilation treatment of sleep-disordered breathing with predominant central sleep apnoea in patients with chronic heart failure. Eur J Heart Fail. 2013;15:937–943. doi: 10.1093/eurjhf/hft051.
    1. Swedberg K, Cleland J, Dargie H, Drexler H, Follath F, Komajda M, Tavazzi L, Smiseth OA, Gavazzi A, Haverich A, Hoes A, Jaarsma T, Korewicki J, Lévy S, Linde C, Lopez-Sendon JL, Nieminen MS, Piérard L, Remme WJ. Task Force for the Diagnosis and Treatment of Chronic Heart Failure of the European Society of Cardiology: 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;26:1115–1140.
    1. Wang Y, Teschler T, Weinreich G, Hess S, Wessendorf TE, Teschler H. [Validation of microMESAM as screening device for sleep disordered breathing] Pneumologie. 2003;57:734–740.
    1. Erman MK, Stewart D, Einhorn D, Gordon N, Casal E. Validation of the ApnoeaLink for the screening of sleep apnoea: a novel and simple single-channel recording device. J Clin Sleep Med. 2007;3:387–392.
    1. Ng SS, Chan TO, To KW, Ngai J, Tung A, Ko FW, Hui DS. Validation of a portable recording device (ApnoeaLink) for identifying patients with suspected obstructive sleep apnoea syndrome. Intern Med J. 2009;39:757–762. doi: 10.1111/j.1445-5994.2008.01827.x.
    1. Chen H, Lowe AA, Bai Y, Hamilton P, Fleetham JA, Almeida FR. Evaluation of a portable recording device (ApnoeaLink) for case selection of obstructive sleep apnoea. Sleep Breath. 2009;13:213–219. doi: 10.1007/s11325-008-0232-4.
    1. Clark AL, Crabbe S, Aziz A, Reddy P, Greenstone M. Use of a screening tool for detection of sleep-disordered breathing. J Laryngol Otol. 2009;123:746–749. doi: 10.1017/S0022215109004794.
    1. Ragette R, Wang Y, Weinreich G, Teschler H. Diagnostic performance of single airflow channel recording (ApnoeaLink) in home diagnosis of sleep apnoea. Sleep Breath. 2010;14:109–114. doi: 10.1007/s11325-009-0290-2.
    1. Weinreich G, Armitstead J, Töpfer V, Wang YM, Wang Y, Teschler H. Validation of ApneaLink as screening device for Cheyne-Stokes respiration. Sleep. 2009;32(4):553–557.
    1. Randerath WJ, Treml M, Priegnitz C, Stieglitz S, Hagmeyer L, Morgenstern C. Evaluation of a noninvasive algorithm for differentiation of obstructive and central hypopneas. Sleep. 2013;36(3):363–368.
    1. Berry RB, Budhiraja R, Gottlieb DJ, Gozal D, Iber C, Kapur VK, Marcus CL, Mehra R, Parthasarathy S, Quan SF, Redline S, Strohl KP, Davidson Ward SL, Tangredi MM. American Academy of Sleep Medicine: Rules for scoring respiratory events in sleep: update of the 2007 AASM Manual for the Scoring of Sleep and Associated Events. Deliberations of the Sleep Apnea Definitions Task Force of the American Academy of Sleep Medicine. J Clin Sleep Med. 2012;8(5):597–619.
    1. Brown ML, Gersh BJ, Holmes DR, Bailey KR, Sundt TM 3rd. From randomized trials to registry studies: translating data into clinical effectiveness. Nat Clin Pract Cardiovasc Med. 2008;5:38–39.
    1. Budhiraja R, Budhiraja P, Quan SF. Sleep disordered breathing and cardiovascular disorder. Respir Care. 2010;55:1322–1332.
    1. Damy T, Margarit L, Noroc A, Bodez D, Guendouz S, Boyer L, Drouot X, Lamine A, Paulino A, Rappeneau, Stoica M-H, Dubois-Randé J-L, Adnot S, Hittinger L, D’Ortho MP. Prognostic impact of sleep-disordered breathing and its treatment with nocturnal ventilation for chronic heart failure. Eur J Heart Fail. 2012;14:1009–1019. doi: 10.1093/eurjhf/hfs085.
    1. Kasai T, Bradley D. Obstructive sleep apnea and heart failure. J Am Coll Cardiol. 2011;57:119–127. doi: 10.1016/j.jacc.2010.08.627.
    1. Schulz R, Blau A, Börgel J, Duchna HW, Fietze I, Koper I, Prenzel R, Schädlich S, Schmitt J, Tasci S, Andreas S. working group Kreislauf und Schlaf of the German Sleep Society (DGSM) Sleep apnoea in heart failure. Eur Respir J. 2007;29(6):1201–1205. doi: 10.1183/09031936.00037106.
    1. Javaheri S. Sleep disorders in systolic heart failure: a prospective study of 100 male patients. The final report Int J Cardiol. 2006;106(1):21–28. doi: 10.1016/j.ijcard.2004.12.068.
    1. Sin DD, Fitzgerald F, Parker JD, Newton G, Floras JS, Bradley TD. Risk factors for central and obstructive sleep apnea in 450 men and women with congestive heart failure. Am J Respir Crit Care Med. 1999;160(4):1101–1106. doi: 10.1164/ajrccm.160.4.9903020.
    1. Yumino D, Wang H, Floras JS, Newton GE, Mak S, Ruttanaumpawan P, Parker JD, Bradley TD. Prevalence and physiological predictors of sleep apnea in patients with heart failure and systolic dysfunction. J Card Fail. 2009;15(4):279–285. doi: 10.1016/j.cardfail.2008.11.015.
    1. Paulino A, Damy T, Margarit L, Stoïca M, Deswarte G, Khouri L, Vermes E, Meizels A, Hittinger L, D’Ortho M-P. Prevalence of sleep-disordered breathing in a 316-patient French cohort of stable congestive heart failure. Arch Cardiovasc Dis. 2009;102:169–175. doi: 10.1016/j.acvd.2008.12.006.
    1. Dolliner P, Brammen L, Graf S, Huelsmann M, Stielbellehner L, Gleiss A, Uhl P, Steurer G. Portable recording for detecting sleep disorder breathing in patients under the care of a heart failure clinic. Clin Res Cardiol. 2013;102:535–542. doi: 10.1007/s00392-013-0563-4.
    1. Kourouklis SP, Filippatos G. Central sleep apnea treatment in heart failure: are we counting chickens before they are hatched? Expert Rev Cardiovasc Ther. 2012;10:275–278. doi: 10.1586/erc.12.12.

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