What is the remaining status of adaptive servo-ventilation? The results of a real-life multicenter study (OTRLASV-study) : Adaptive servo-ventilation in real-life conditions

Dany Jaffuel, Carole Philippe, Claudio Rabec, Jean-Pierre Mallet, Marjolaine Georges, Stefania Redolfi, Alain Palot, Carey M Suehs, Erika Nogue, Nicolas Molinari, Arnaud Bourdin, Dany Jaffuel, Carole Philippe, Claudio Rabec, Jean-Pierre Mallet, Marjolaine Georges, Stefania Redolfi, Alain Palot, Carey M Suehs, Erika Nogue, Nicolas Molinari, Arnaud Bourdin

Abstract

Backgrounds: As a consequence of the increased mortality observed in the SERVE-HF study, many questions concerning the safety and rational use of ASV in other indications emerged. The aim of this study was to describe the clinical characteristics of ASV-treated patients in real-life conditions.

Methods: The OTRLASV-study is a prospective, 5-centre study including patients who underwent ASV-treatment for at least 1 year. Patients were consecutively included in the study during the annual visit imposed for ASV-reimbursement renewal.

Results: 177/214 patients were analysed (87.57% male) with a median (IQ25-75) age of 71 (65-77) years, an ASV-treatment duration of 2.88 (1.76-4.96) years, an ASV-usage of 6.52 (5.13-7.65) hours/day, and 54.8% were previously treated via continuous positive airway pressure (CPAP). The median Epworth Scale Score decreased from 10 (6-13.5) to 6 (3-9) (p < 0.001) with ASV-therapy, the apnea-hypopnea-index decreased from 50 (38-62)/h to a residual device index of 1.9 (0.7-3.8)/h (p < 0.001). The majority of patients were classified in a Central-Sleep-Apnea group (CSA; 59.3%), whereas the remaining are divided into an Obstructive-Sleep-Apnea group (OSA; 20.3%) and a Treatment-Emergent-Central-Sleep-Apnea group (TECSA; 20.3%). The Left Ventricular Ejection Fraction (LVEF) was > 45% in 92.7% of patients. Associated comorbidities/etiologies were cardiac in nature for 75.7% of patients (neurological for 12.4%, renal for 4.5%, opioid-treatment for 3.4%). 9.6% had idiopathic central-sleep-apnea. 6.2% of the patients were hospitalized the year preceding the study for cardiological reasons. In the 6 months preceding inclusion, night monitoring (i.e. polygraphy or oximetry during ASV usage) was performed in 34.4% of patients, 25.9% of whom required a subsequent setting change. According to multivariable, logistic regression, the variables that were independently associated with poor adherence (ASV-usage ≤4 h in duration) were TECSA group versus CSA group (p = 0.010), a higher Epworth score (p = 0.019) and lack of a night monitoring in the last 6 months (p < 0.05).

Conclusions: In real-life conditions, ASV-treatment is often associated with high cardiac comorbidities and high compliance. Future research should assess how regular night monitoring may optimize devices settings and patient management.

Trial registration: The OTRLASV study is registered on ClinicalTrials.gov (Identifier: NCT02429986 ) on 1 April 2015.

Keywords: Adaptive servo-ventilation; CPAP; Central sleep apnea; Chronic heart failure; Obstructive sleep apnea; Sleep-disordered breathing; Treatment emergent central sleep apnea.

Conflict of interest statement

Dr. Dany Jaffuel has performed lecturing at sponsored meetings for the following companies in the last 5 years: Apard, Bastide, Loewenstein Medical, Philips, SEFAM. He has sat on advisory boards for the following companies in the last 5 years: Lowenstein Medical, SEFAM. He has received sponsorship support to attend academic meetings in the last 5 years from Lowenstein Medical, Resmed, Philips and SEFAM.

- Dr. Alain Palot has performed lecturing at sponsored meetings for the following companies in the last 5 years: ARARD, Resmed, Philips. He has sat on advisory boards for the following company in the last 5 years: Resmed

- Dr. Claudio Rabec has performed lecturing at sponsored meetings and/or participated in boards for the following companies in the last 5 years: Resmed, Philips, Lowenstein, Air Liquide Medical Systems

AB, CMS, CP, EN, JPM, NM, MG, SR report no conflicts of interest in relation to the present work.

Figures

Fig. 1
Fig. 1
Flow chart of the study. ASV: Adaptive Servo-Ventilation; AHI: Apnea Hypopnea Index; TECSA: Treatment Emergent Central Sleep Apnea; SA: Sleep Apnea, SDB: Sleep Disordered Breathing
Fig. 2
Fig. 2
Comorbidities/etiologies associated with ASV prescription. The number and percentages of the total population are presented (1 patient = 0.6%). For 33 patients (18.6%), no comorbidity was related to SA
Fig. 3
Fig. 3
Exams (polygraphy (PG) or oximetry) performed in the 6 months preceding study inclusion, depending of the ASV-initiation date

References

    1. Javaheri S, Brown LK, Randerath WJ. Positive airway pressure therapy with adaptive servoventilation: part 1: operational algorithms. Chest. 2014;146:514–523. doi: 10.1378/chest.13-1776.
    1. Teschler H, Döhring J, Wang YM, Berthon-Jones M. Adaptive pressure support servo-ventilation: a novel treatment for Cheyne-stokes respiration in heart failure. Am J Respir Crit Care Med. 2001;164:614–619. doi: 10.1164/ajrccm.164.4.9908114.
    1. Aurora RN, Chowdhuri S, Ramar K, Bista SR, Casey KR, Lamm CI, et al. The treatment of central sleep apnea syndromes in adults: practice parameters with an evidence-based literature review and meta-analyses. Sleep. 2012;35:17–40. doi: 10.5665/sleep.1580.
    1. Javaheri S, Brown LK, Randerath WJ. Clinical applications of adaptive servoventilation devices: part 2. Chest. 2014;146:858–868. doi: 10.1378/chest.13-1778.
    1. Randerath W, Verbraecken J, Andreas S, Arzt M, Bloch KE, Brack T, et al. Definition, discrimination, diagnosis and treatment of central breathing disturbances during sleep. Eur Respir J. 2017;49. 10.1183/13993003.00959-2016.
    1. Aurora RN, Bista SR, Casey KR, Chowdhuri S, Kristo DA, Mallea JM, et al. Updated adaptive servo-ventilation recommendations for the 2012 AASM guideline: “The treatment of central sleep apnea syndromes in adults: practice parameters with an evidence-based literature review and meta-analyses.”. J Clin Sleep Med Med. 2016;12:757–761. doi: 10.5664/jcsm.5812.
    1. Cowie MR, Woehrle H, Wegscheider K, Angermann C, d’Ortho M-P, Erdmann E, et al. Adaptive servo-ventilation for central sleep apnea in systolic heart failure. N Engl J Med. 2015;373:1095–1105. doi: 10.1056/NEJMoa1506459.
    1. Oldenburg O, Wellmann B, Bitter T, Fox H, Buchholz A, Freiwald E, et al. Adaptive servo-ventilation to treat central sleep apnea in heart failure with reduced ejection fraction: the Bad Oeynhausen prospective ASV registry. Clin Res. 2018;107:719–728.
    1. Oldenburg O. Cheyne-stokes respiration in chronic heart failure. Treatment with adaptive servoventilation therapy. Circ J. 2012;76:2305–2317. doi: 10.1253/circj.CJ-12-0689.
    1. Carnevale C, Georges M, Rabec C, Tamisier R, Levy P, Pépin J-L. Effectiveness of adaptive servo ventilation in the treatment of hypocapnic central sleep apnea of various etiologies. Sleep Med. 2011;12:952–958. doi: 10.1016/j.sleep.2011.07.008.
    1. Momomura S-I, Seino Y, Kihara Y, Adachi H, Yasumura Y, Yokoyama H. Adaptive servo-ventilation therapy using an innovative ventilator for patients with chronic heart failure: a real-world, multicenter, retrospective, observational study (SAVIOR-R) Heart Vessel. 2015;30:805–817. doi: 10.1007/s00380-014-0558-8.
    1. Malfertheiner MV, Lerzer C, Kolb L, Heider K, Zeman F, Gfüllner F, et al. Whom are we treating with adaptive servo-ventilation? A clinical post hoc analysis. Clin Res. 2017;106:702–710.
    1. Randerath W, Schumann K, Treml M, Herkenrath S, Castrogiovanni A, Javaheri S, et al. Adaptive servoventilation in clinical practice: beyond SERVE-HF? ERJ Open Res. 2017;3(4):00078–02017. doi: 10.1183/23120541.00078-2017.
    1. Mansukhani MP, Kolla BP, Naessens JM, Gay PC, Morgenthaler TI. Effects of adaptive servoventilation therapy for central sleep apnea on health care utilization and mortality: a population-based study. J Clin Sleep Med. 2019;15:119–128. doi: 10.5664/jcsm.7584.
    1. Jaffuel D, Molinari N, Berdague P, Pathak A, Galinier M, Dupuis M, et al. Impact of sacubitril-valsartan combination in patients with chronic heart failure and sleep apnoea syndrome: the ENTRESTO-SAS study design. ESC Heart Fail. 2018;5:222–230. doi: 10.1002/ehf2.12270.
    1. Pépin J-LD, Woehrle H, Liu D, Shao S, Armitstead JP, Cistulli PA, et al. Adherence to positive airway therapy after switching from CPAP to ASV: a big data analysis. J Clin Sleep Med. 2018;14:57–63. doi: 10.5664/jcsm.6880.
    1. O’Connor CM, Whellan DJ, Fiuzat M, Punjabi NM, Tasissa G, Anstrom KJ, et al. Cardiovascular outcomes with minute ventilation-targeted adaptive servo-ventilation therapy in heart failure: the CAT-HF trial. J Am Coll Cardiol. 2017;69:1577–1587. doi: 10.1016/j.jacc.2017.01.041.
    1. Huang H-CC, Hillman DR, McArdle N. Control of OSA during automatic positive airway pressure titration in a clinical case series: predictors and accuracy of device download data. Sleep. 2012;35:1277–1283A. doi: 10.5665/sleep.2086.
    1. Weaver TE, Maislin G, Dinges DF, Bloxham T, George CFP, Greenberg H, et al. Relationship between hours of CPAP use and achieving normal levels of sleepiness and daily functioning. Sleep. 2007;30:711–719. doi: 10.1093/sleep/30.6.711.
    1. Piccini JP, Pokorney SD, Anstrom KJ, Oldenburg O, Punjabi NM, Fiuzat M, et al. Adaptive servo-ventilation reduces atrial fibrillation burden in patients with heart failure and sleep apnea. Heart Rhythm. 2019;16:91–97. doi: 10.1016/j.hrthm.2018.07.027.
    1. Woehrle H, Cowie MR, Eulenburg C, Suling A, Angermann C, d’Ortho M-P, et al. Adaptive servo ventilation for central sleep apnoea in heart failure: SERVE-HF on-treatment analysis. Eur Respir J. 2017;50. 10.1183/13993003.01692-2016.
    1. Lee C-H, Barbé F. Adaptive servoventilation for central sleep apnoea in heart failure: a broken dream. Lancet Respir Med. 2016;4:846–847. doi: 10.1016/S2213-2600(16)30271-5.
    1. Platt AB, Kuna ST, Field SH, Chen Z, Gupta R, Roche DF, et al. Adherence to sleep apnea therapy and use of lipid-lowering drugs: a study of the healthy-user effect. Chest. 2010;137:102–108. doi: 10.1378/chest.09-0842.
    1. Villar I, Izuel M, Carrizo S, Vicente E, Marin JM. Medication adherence and persistence in severe obstructive sleep apnea. Sleep. 2009;32:623–628. doi: 10.1093/sleep/32.5.623.
    1. Reiter J, Zleik B, Bazalakova M, Mehta P, Thomas RJ. Residual events during use of CPAP: prevalence, predictors, and detection accuracy. J Clin Sleep Med. 2016;12:1153–1158. doi: 10.5664/jcsm.6056.
    1. Schwab RJ, Badr SM, Epstein LJ, Gay PC, Gozal D, Kohler M, et al. An official American Thoracic Society statement: continuous positive airway pressure adherence tracking systems. The optimal monitoring strategies and outcome measures in adults. Am J Respir Crit Care Med. 2013;188:613–620. doi: 10.1164/rccm.201307-1282ST.
    1. Thomas RJ, Bianchi MT. Urgent need to improve PAP management: the devil is in two (fixable) details. J Clin Sleep Med. 2017;13:657–664. doi: 10.5664/jcsm.6574.
    1. Tomita Y, Kasai T, Kasuga S, Morimoto K, Takaya H, Maeno K, et al. Evaluation of the apnea-hypopnea index determined by adaptive-servo ventilation devices in heart failure patients with sleep disordered breathing. Eur Respir J. 2014;44:P2008.
    1. Gunn S, Naik S, Bianchi MT, Thomas RJ. Estimation of adaptive ventilation success and failure using polysomnogram and outpatient therapy biomarkers. Sleep. 2018;41(9). 10.1093/sleep/zsy033.
    1. Silveira M-G, Sampol G, Cambrodi R, Ferre À, Lloberes P. Adaptive servoventilation device software in the assessment of residual respiratory events in patients with central or complex apnoeas. Arch Bronconeumol. 2017;53:455–457. doi: 10.1016/j.arbres.2016.11.026.
    1. The report of an American Academy of Sleep Medicine Task Force. Sleep-related breathing disorders in adults: recommendations for syndrome definition and measurement techniques in clinical research. Sleep. 1999;22:667–89.
    1. Berry RB, Budhiraja R, Gottlieb DJ, Gozal D, Iber C, Kapur VK, et al. 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;8:597–619.

Source: PubMed

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