Adaptive Servo-ventilation Therapy Research Articles

Clinical advantages of reduced expiratory positive airway pressure setting in adaptive servo-ventilation therapy

Clinical advantages of reduced expiratory positive airway pressure setting in adaptive servo-ventilation therapy

Chronic Effects of Adaptive Servo-Ventilation Therapy on Mortality and the Urgent Rehospitalization Rate in Patients Experiencing Recurrent Admissions for Heart Failure - A Multicenter Prospective Observational Study (SAVIOR-L).

This study investigated whether the chronic use of adaptive servo-ventilation (ASV) reduces all-cause mortality and the rate of urgent rehospitalization in patients with heart failure (HF). This multicenter prospective observational study enrolled patients hospitalized for HF in Japan between 2019 and 2020 who were treated either with or without ASV therapy. Of 845 patients, 110 (13%) received chronic ASV at hospital discharge. The primary outcome was a composite of all-cause death and urgent rehospitalization for HF, and was observed in 272 patients over a 1-year follow-up. Following 1:3 sequential propensity score matching, 384 patients were included in the subsequent analysis. The median time to the primary outcome was significantly shorter in the ASV than in non-ASV group (19.7 vs. 34.4 weeks; P=0.013). In contrast, there was no significant difference in the all-cause mortality event-free rate between the 2 groups. Chronic use of ASV did not impact all-cause mortality in patients experiencing recurrent admissions for HF.

Abstract 12622: Long Term Use of Adaptive Servo Ventilation Improves and Maintains Cardiac Function in Patients With Heart Failure With Central Sleep Apnea and Prevents Readmission Due to Worsening Heart Failure Compared to Short Term Use

Introduction: Central sleep apnea (CSA) is closely associated with poor prognosis in heart failure (HF) patients. Adaptive servo-ventilation (ASV) was expected as a new treatment for HF patients with CSA. However, the efficacy of ASV is controversial, especially the efficacy of long-term use has remained unclear. Methods: We retrospectively examined all HF patients with CSA treated with ASV seen between May 2008 and November 2022 in our hospital who had not been admitted to the hospital due to worsening HF in the 6 months before initiating ASV therapy. We divided them into 2 groups: (A) non-continues-ASV-treated patients; (B) continues-ASV-treated patients. The outcome was a composite of readmission due to worsening HF and all-cause mortality. Results: During a median follow-up of 10.3 years after leaving the hospital, 11 patients died out of 101 patients. Twenty-two patients (group A) could not continue to use ASV because of its discomfort. Seventy-nine patients (group B) could continue to use the ASV device at night after leaving the hospital over a long period. There were almost no significant differences in the baseline characteristics between the two groups. In group B, during 6-, 12-, and 24-month observations, left ventricular ejection fraction (46.4 +/- 17.9 to 47.1 +/- 15.6, 49.8 +/- 15.8, and 48.2+/- 18.9%, p<0.05 compared with baseline) and brain natriuretic peptide (685.5 +/- 1087.2 to 233.1+/- 362.9, 391.8 +/- 929.0 and 166.9 +/- 195.1 pg/ml, p<0.05 compared with baseline) improved significantly. And there was significantly less readmission by worsening HF than in group A (log-rank P<0.001). However, there were no significant differences in all-cause mortality between the two groups (log-rank P=0.221). Conclusions: This study showed that long-term ASV therapy for more than 10 years reduced readmission by worsening HF with CSA patients compared to short-term use due to improved and maintained cardiac function but did not affect mortality.

The efficacy and safety of adaptive servo-ventilation therapy for heart failure with preserved ejection fraction.

It is unclear whether adaptive servo-ventilation (ASV) therapy for heart failure with preserved ejection fraction (HFpEF) is effective. The aim of this study was to investigate the details of ASV use, and to evaluate the effectiveness and safety of ASV in real-world HFpEF patients. We retrospectively enrolled 36 HFpEF patients at nine cardiovascular centers who initiated ASV therapy during hospitalization or on outpatient basis and were able to continue using it at home from 2012 to 2017 and survived for at least one year thereafter. The number of hospitalizations for heart failure (HF) during the 12months before and 12months after introduction of ASV at home was compared. The median number of HF hospitalizations for each patient was significantly reduced from 1 [interquartile range: 1-2] in the 12months before introduction of ASV to 0 [0-0] in the 12months after introduction of ASV (p < 0.001). In subgroup analysis, reduction in heart failure hospitalization was significantly greater in female patients, patients with a body mass index < 25, and those with moderate or severe tricuspid valve regurgitation. In patients with HFpEF, the number of HF hospitalizations was significantly decreased after the introduction of ASV. HFpEF patients with female sex, BMI < 25, or moderate to severe tricuspid valve regurgitation are potential candidates who might benefit from ASV therapy.

Experience With Adaptive Servo-Ventilation Among Veterans in the Post-SERVE-HF Era.

The sleep medicine community has struggled to identify the ideal role for adaptive servo-ventilation (ASV) therapy following a study that found increased mortality in patients with central sleep apnea (CSA) and heart failure with reduced ejection fraction who used ASV therapy. We aimed to identify characteristics of patients who benefit from ASV therapy. We performed a record review of all patients treated with ASV therapy at the Hampton Veterans Affairs Medical Center in Virginia from January 1, 2015, to April 30, 2020. Clinical and polysomnographic characteristics of patients adherent to therapy were compared with those that were not adherent. Our cohort of 31 patients was entirely male with a mean age of 67.2 years, body mass index of 34.0, and Epworth Sleepiness Scale score of 10.9. Primary CSA was initially diagnosed in 3 patients (10%), comorbid obstructive sleep apnea (OSA) and CSA in 9 (29%), and primary OSA in 19 (61%). Seventeen patients (55%) met minimal adherence criteria with ASV therapy. The obstructive apnea-hypopnea index (AHI), as a proportion of the total pretreatment AHI, was higher in adherent patients (81.5%) vs nonadherent patients (46.7%) (P = .02). The median residual AHI was lower in the adherent group, both as absolute values (1.7 vs 4.7 events/h; P = .004) and as a percentage of the pretreatment AHI (3.1% vs 10.2%; P = .002). Patients using ASV devices regularly have a larger component of obstructive sleep-disordered breathing and obtain greater objective benefit from ASV than those that do not. This understanding may help to identify patients that will most benefit from this debated form of therapy.

Abstract 10454: Heart Failure With Recovered Ejection Fraction is Good Therapeuticmerkmal for Adaptive-Servo Ventilation Therapy in Patients With Heart Failure

Introduction: Heart failure with recovered ejection fraction (HFrecEF) is a complex clinical entity in which biology and clinical management. Previous clinical trial showed adaptive-servo ventilation (ASV) therapy is harmful for patient with heart failure with reduced ejection fraction (HFrEF), whereas we can initiate ASV for patients with HFrEF by adhering rigidly to Japanese statement about the proper use of ASV for HF. Hypothesis: It is still unclear whether ASV therapy is really harmful in patients with HFrecEF. Our aim is to estimate that ASV therapy is really harmful in patients with HFrecEF by estimating biomarkers and fatal cardiovascular events. Methods: The study group consisted of 78 patients with HF (age;70±12 years). Baseline LVEF was 27.8±8.5%. After optimal medical therapy, ASV was initiated as an additional HF treatment. After 6-month follow-up, we classified into 2 groups by result of LVEF after ASV therapy. Group A (n=20) was categorized as HFrecEF {low pre-LVEF (&lt;45%) and improved post-LVEF (≧45%)}, Group B (n=58) was categorized as HFrEF {low pre-LVEF (&lt;45%) and not improved post-LVEF (&lt;45%)}. We estimate the changes of BNP and fatal cardiovascular events after ASV therapy. Results: Before ASV therapy, BNP did not show significant difference in 2 groups {Group A: 439(149-1344) pg/ml vs. Group B: 531(265-892) pg/ml, p=0.73}. After ASV therapy, the changes of BNP showed significant differences (Figure 1A), LVEF also showed significant differences in 2 groups (Group A: 52.3±7.5% vs. Group B: 30.8±3.7%, p=0.039). The fatal cardiovascular events rate after three-year follow-up showed significant good prognosis in Group A (Figure 1B). Conclusions: Our study showed that approximately one in four patients can change from HFrEF to HFrecEF, and ASV is acceptable and effective treatment for patients with HFrecEF by contributing to low fatal cardiovascular events and improvement of BNP level.

Effect of adaptive servo ventilation on central sleep apnea and sleep structure in systolic heart failure patients: polysomnography data from the SERVE-HF major sub study.

This SERVE-HF (Treatment of Predominant Central Sleep Apnea by Adaptive Servo Ventilation in Patients With Heart Failure) sub study analysis evaluated polysomnography (PSG) data in patients with heart failure with reduced ejection fraction (HFrEF) and predominant central sleep apnea (CSA) randomised to guideline-based medical therapy, with or without adaptive servo ventilation (ASV). Patients underwent full overnight PSG at baseline and at 12 months. All PSG recordings were analysed by a core laboratory. Only data for patients with baseline and 3- or 12-month values were included. The sub study included 312 patients; the number with available PSG data differed for each variable (94-103 in the control group, 77-99 in the ASV group). After 12 months, baseline-adjusted respiratory measures were significantly better in the ASV group versus control. Although some between-group differences in sleep measures were seen at 12 months (e.g., better sleep efficiency in the ASV group), these were unlikely to be clinically significant. The number of periodic leg movements during sleep (PLMS) increased in the ASV group (p=0.039). At 12 months, the respiratory arousal index was significantly lower in the ASV versus control group (p < 0.001), whilst the PLMS-related arousal index was significantly higher in the ASV group (p=0.04 versus control). ASV attenuated the respiratory variables characterising sleep apnea in patients with HFrEF and predominant CSA in SERVE-HF. Sleep quality improvements during ASV therapy were small and unlikely to be clinically significant. The increase in PLMS and PLMS-related arousals during ASV warrants further investigation, particularly relating to their potential association with increased cardiovascular risk.

Sleep Breathing Disorders in Heart Failure.

Sleep-disordered breathing (SDB), including obstructive sleep apnea, central sleep apnea (CSA), and Cheyne-Stokes respiration, is common in patients with heart failure (HF) and associated with lower left ventricular ejection fraction (EF), increased arrhythmia burden, and increased mortality. Continuous positive airway pressure therapy improves short-term and long-term outcomes in HF patients. Adaptive servoventilation (ASV) therapy in patients with low-EF HF with predominant CSA is not recommended. Ongoing trials are evaluating whether ASV will have a role in SDB treatment. Phrenic nerve stimulation is an emerging treatment option that has shown promising outcomes. All HF patients should be screened for SDB.

Pressure Ramp Testing for Optimization of End-Expiratory Pressure Settings in Adaptive Servo-Ventilation Therapy.

Background: Clinical outcomes of adaptive servo-ventilation (ASV) therapy have not been rigorously assessed. Optimal device settings ascertained by a pressure ramp test may increase the utility of ASV therapy. Methods and Results: Patients with congestive heart failure (CHF) who underwent ASV therapy were prospectively included in the study. Patients in the ramp test group underwent a pressure ramp test, during which the end-expiratory pressure was optimized to maximize cardiac output (assessed using the AESCLONE mini). The control group consisted of age-matched patients who received ASV therapy with a default pressure 5 cmH2O. The primary endpoint was a composite of all-cause death and heart failure recurrence, and was compared between the 2 groups. Of a total of 37 patients, 11 each were included in the ramp test and control groups. Median patient age was 73 years (interquartile range 59–75 years) and 16 were men. There were no significant differences in baseline characteristics between the 2 groups. In the ramp test group, end-expiratory pressure was optimized between 2 and 5 cmH2O in each patient. The 2-year incidence of the primary endpoint tended to be lower in the ramp test than control group (0% vs. 59%; P=0.080). Conclusions: Pressure ramp testing may be a promising strategy to optimize device pressure settings in patients with CHF undergoing ASV therapy. Larger-scale trials are needed to validate our findings.

Joubert Sendromu ve Biot Solunumunun Epilepsi Olarak Yanlış Teşhisi

Joubert syndrome (JS) is a rare ciliopathy characterized by neurodevelopmental delay and irregular breathing patterns. Here we present a patient with JS, who was misdiagnosed as having epilepsy. A five year-old girl with JS was referred due to excessive daytime sleepiness. She was diagnosed as having apneic seizures, and given antiseizure medications with no benefit. Apneas were present during wakefulness lasting for more than one minute, with sudden myoclonic jerks characterized by the extension of the body and the flexion of the limbs at the resume of respiration with paradoxical breathing, hyperventilation and tachypnea. A full-night polysomnography (PSG) revealed pediatric obstructive and central sleep apnea syndromes. The patient was effectively treated by adaptive servo ventilation therapy. Respiratory control disturbances are commonly encountered in the children with JS. Although routine electroencephalography may be helpful in differentiation of the apneas of epileptic origin, polygraphic recordings and/or PSG better delineate the pathophysiology.

Opioids and obstructive sleep apnea.

Freire C, Sennes LU, Polotsky VY. Opioids and obstructive sleep apnea. J Clin Sleep Med. 2022;18(2):647-652.

Large telemonitoring databases: the good, the bad, and the useful.

Large telemonitoring databases: the good, the bad, and the useful.

Association Between Adaptive Servo-Ventilation Therapy and Renal Function.

Cardio-renal syndrome is a challenging clinical entity to manage, and is often associated with increased morbidity and mortality. We hypothesized that adaptive servo-ventilation (ASV), non-invasive positive pressure ventilation that ameliorates systemic/pulmonary congestion, may improve renal function in patients with symptomatic heart failure complicated by the cardio-renal syndrome. Patients with symptomatic congestive heart failure who underwent ASV therapy for over 1 month were included in this retrospective study. The trajectory of the estimated glomerular filtration ratio (eGFR) between the pre-1 month period and the post-one-month period (on ASV) were compared. A total of 81 patients (median 65 years old, 65 men) were included. eGFR decreased during the pre-1 month period from 52.7 (41.7, 64.6) down to 49.9 (37.3, 63.5) mL/minute/1.73 m2 (P < 0.001) whereas we observed an increase following one-month of ASV therapy up to 53.4 (38.6, 68.6) mL/minute/1.73 m2 (P = 0.022). A reduction in furosemide equivalent dose following the initiation of ASV therapy was independently associated with increases in eGFR with an adjusted odds ratio of 13.72 (95% confidence interval 3.40-55.3, P < 0.001). In conclusion, short-term ASV therapy was associated with the preservation of renal function, particularly when the dose of loop diuretics was concomitantly reduced.

Characterizing respiratory parameters, settings, and adherence in real-world patients using adaptive servo ventilation therapy: big data analysis.

There is minimal guidance around how to optimize inspiratory positive airway pressure (IPAP) levels during use of adaptive servo ventilation (ASV) in clinical practice. This real-world data analysis investigated the effects of IPAP and minimum pressure support settings on respiratory parameters and adherence in ASV-treated patients. A United States-based telemonitoring database was queried for patients starting ASV between August 1, 2014 and November 30, 2019. Patients meeting the following criteria were included: United States-based patients aged ≥ 18 years; AirCurve 10 device (ResMed); and ≥ 1 session with usage of ≥ 1 hour in the first 90 days. Key outcomes were mask leak and residual apnea-hypopnea index at different IPAP settings, adherence and therapy termination rates, and respiratory parameters at different minimum pressure support settings. There were 63,996 patients included. Higher IPAP was associated with increased residual apnea-hypopnea index and mask leak but did not impact device usage per session (average > 6 h/day at all IPAP settings; 6.7 h/day at 95th percentile IPAP 25 cm H2O). There were no clinically relevant differences in respiratory rate, minute ventilation, leak, and residual apnea-hypopnea index across all possible minimum pressure support settings. Patients with a higher 95th percentile IPAP or with minimum pressure support of 3 cm H2O were most likely to remain on ASV therapy at 1 year. Our findings showed robust levels of longer-term adherence to ASV therapy in a large group of real-world patients. There were no clinically important differences in respiratory parameters across a range of pressure and pressure support settings. Future work should focus on the different phenotypes of patients using ASV therapy. Malhotra A, Benjafield AV, Cistulli PA, etal. Characterizing respiratory parameters, settings, and adherence in real-world patients using adaptive servo ventilation therapy: big data analysis. J Clin Sleep Med. 2021;17(12):2355-2362.

Adaptive Servo-ventilation Therapy Results in the Prevention of Arrhythmias in Patients with Heart Failure Due to Ischemic Heart Disease.

Objective Whether or not adaptive servo-ventilation (ASV) is effective in preventing arrhythmias in patients with heart failure (HF) due to ischemic heart disease (IHD) is unclear. This study estimated the effects of ASV therapy on arrhythmias in patients with HF due to IHD. Methods One hundred and forty-one consecutive hospitalized patients with HF due to IHD (mean age: 74.9±11.9 years old) were retrospectively assessed in this study. Of the 141 patients, 75 were treated with ASV (ASV group), and 66 were treated without ASV (Non-ASV group). We estimated the incidence of arrhythmias, including paroxysmal atrial fibrillation (PAF) and ventricular tachycardia (VT), during one-year follow-up in both groups using multivariable logistic regression models. Results Men accounted for 55.3% of the study population. There were no significant differences in the baseline clinical characteristic data between the ASV and Non-ASV groups with respect to age, sex, heart rate, risk factors, oral medication, or laboratory data, including the estimated glomerular filtration rate (eGFR), brain natriuretic peptide, and left ventricular ejection fraction. ASV therapy was associated with a reduced incidence of arrhythmia after adjusting for demographic and cardiovascular disease risk factors (odds ratio, 0.27; 95% confidence interval, 0.11 to 0.63; p<0.01; compared to the Non-ASV group). In addition, at the 1-year follow-up, an improvement (increase) in the eGFR was found in the ASV group but not in the Non-ASV group. Conclusion ASV therapy was able to prevent arrhythmias, including PAF and VT, with short-term improvements in the renal function in patients with HF due to IHD.

826 Central Sleep Apnea associated with Sodium Oxybate– A Case Series

Abstract Introduction Sodium oxybate (SO) is indicated to treat cataplexy and excessive daytime sleepiness (EDS) in patients with narcolepsy. Only a handful of cases have been reported of new-onset Central Sleep Apnea (CSA) in the setting of SO use. We present 3 patients who developed CSA in the setting of use of SO. Report of case(s) Patient 1: A 25-y/o man presented with hypersomnolence. His diagnostic polysomnogram (PSG) showed moderate Obstructive Sleep Apnea (OSA), and he was placed on Continuous Positive Airway Pressure (CPAP) therapy. Due to persistent hypersomnia in the setting of effectively treated OSA, he had a Multiple Sleep Latency Test (MSLT), which revealed pathological sleepiness with a mean latency of 3.8 minutes with a sleep-onset REM on the overnight polysomnogram. SO was started for clinical diagnosis of Narcolepsy after he failed other stimulant medications. Hypersomnolence improved though data from his PAP device, home sleep studies, re-titration studies performed when he was on SO demonstrated CSA following 1st or 2nd dose of SO. Patient 2: A 17-y/o man was diagnosed to have Narcolepsy with Cataplexy, based on PSG followed by MSLT. 20 years later, he was diagnosed with OSA based on a PSG and was treated with CPAP. A few years later, he was started on SO for fragmented sleep and EDS. A home sleep study performed when he was on SO, revealed CSA. Later, an in-lab titration study showed CSA with Cheyne-Stokes respiration (CSR), treated with Adaptive Servo-Ventilation (ASV) therapy. Patient 3: A 15-y/o man initially presented after several cataplectic episodes and was diagnosed with Narcolepsy with Cataplexy. His initial PSG showed no evidence of sleep-disordered breathing. A few years later, for persistent cataplectic events, he was started on SO with improvement in the episodes’ frequency. Several years later, a baseline PSG demonstrated OSA and CSA, with frequent CSA events soon after taking SO. The CPAP titration study, performed following the PSG, also revealed frequent CSA following the second dose of SO. Conclusion Close monitoring is warranted with SO use, given some narcolepsy patients’ predisposition to develop CSA. Follow-up studies are needed to address the pathogenesis and management strategies. Support (if any) None

1246 Resolution of Cyclical Ventricular Ectopy with ASV Therapy in a Patient with Cheyne-Stokes Respirations

Abstract Introduction Nocturnal cardiac arrhythmias, ranging from ventricular ectopy to heart blocks, have been commonly reported in patients with obstructive sleep apnea syndrome (OSAS). Potential mechanisms for these rhythm disturbances include OSA-associated hypoxemia, arousal trigger increased sympathetic activity and alterations in intrathoracic pressures leading to cardiac mechanical structural changes. A beneficial effect of CPAP treatment on rhythm abnormalities in patients with obstructive sleep apnea has also been demonstrated. However, the relationship of cardiac arrhythmias and central sleep apnea is not well established. Report of Case We report an 82-year-old male with CAD and Atrial fibrillation s/p PPM who presented for management of his sleep disordered breathing (SDB). Upon review, his original sleep studies performed at an outside facility revealed obstructive sleep apnea and central sleep apnea with Cheyne-Stokes Respirations. The patient presented to us on treatment with an auto-adjusting PAP (APAP) of 7-15 cmH2O with an average delivered pressure of 12 cmH2O. A re-titration study was recommended and demonstrated persistent central sleep apnea with Cheyne-Stokes breathing despite treatment with CPAP 12-18 cmH2O. During this time, EKG monitoring revealed an atrial paced rhythm with frequent premature ventricular beats (PVBs) which occurred in a cyclical pattern. After initiation of Adaptive Servo-Ventilation (ASV), periodic breathing was well controlled and cyclical ventricular ectopy had completely resolved. Conclusion Although CPAP therapy has been shown to improve nocturnal arrhythmias in patients with obstructive sleep apnea, the same relationship, to our knowledge, has not been reported in patients with central sleep apnea and Cheyne-Stokes breathing. This case demonstrates the improvement of cyclical ventricular ectopy with ASV therapy.

Adaptive servo-ventilation therapy does not favourably alter sympatho-vagal balance in sleeping patients with systolic heart failure and central apnoeas: Preliminary data

BackgroundIn contrast to continuous positive airway pressure (CPAP), the use of adaptive servo-ventilation (ASV) for treatment of central sleep apnoea (CSA) was associated with increased mortality in patients with chronic systolic heart failure (CHF). In order to characterize the interplay between sleep-disordered breathing, CHF and sympathovagal balance (SVB) this study investigated the effect of nocturnal CPAP and ASV on SVB in CSA patients with or without CHF. MethodsThirty-seven patients with ongoing positive airway pressure therapy (CPAP or ASV) for CSA (17 patients with systolic CHF - left ventricular ejection fraction <50% - and 20 patients with CSA but no CHF) underwent evaluation of SVB (spectral analysis of heart rate -HRV- and diastolic blood pressure variability) during full nocturnal polysomnography. The night was randomly split into equal parts including no treatment (NT), automatic CPAP and ASV. Data analysis was restricted to stable N2 sleep. ResultsIn patients with CSA and systolic CHF, neither automatic CPAP nor ASV showed favourable effects on parameters reflecting SVB during N2 sleep (all p > 0.05). In contrast, in subjects with CSA without CHF automatic CPAP, but not ASV, favourably altered SVB by decreasing the low frequency and increasing the high frequency component of HRV (both p = 0.03). ConclusionsEffects of various modes of positive airway pressure therapy of CSA on SVB during sleep depend on the mode of pressure support and underlying cardiac function. Automatic CPAP but not ASV favourably influences SVB in subjects without CHF, whereas both interventions leave SVB unchanged in patients with CHF.

Rationale and design of the randomised Treatment of sleep apnoea Early After Myocardial infarction with Adaptive Servo-Ventilation trial (TEAM-ASV I)

AimsIn acute myocardial infarction (AMI), impaired myocardial salvage and large infarct size result in residual heart failure, which is one of the most important predictors of morbidity and mortality after AMI. Sleep-disordered breathing (SDB) is associated with reduced myocardial salvage index (MSI) within the first 3 months after AMI. Adaptive servo-ventilation (ASV) can effectively treat both types of SDB (central and obstructive sleep apnoea). The Treatment of sleep apnoea Early After Myocardial infarction with Adaptive Servo-Ventilation trial (TEAM-ASV I) will investigate the effects of ASV therapy, added to percutaneous coronary intervention (PCI) and optimal medical management of AMI, on myocardial salvage after AMI.Methods/designTEAM ASV-I is a multicentre, randomised, parallel-group, open-label trial with blinded assessment of PCI outcomes. Patients with first AMI and successful PCI within 24 h after symptom onset and SDB (apnoea–hypopnoea index ≥ 15/h) will be randomised (1:1 ratio) to PCI and optimal medical therapy alone (control) or plus ASV (with stratification of randomisation by infarct location; left anterior descending (LAD) or no LAD lesion). The primary outcome is the MSI, assessed by cardiac magnetic resonance imaging. Key secondary outcomes are change of infarct size, left ventricular ejection fraction and B-type natriuretic peptide levels and disease-specific symptom burden at 12 weeks.ConclusionTEAM ASV-I will help to determine whether treatment of SDB with ASV in the acute phase after myocardial infarction contributes to more myocardial salvage and healing.Trial registrationClinicalTrials.gov, NCT02093377. Registered on March 21, 2014.

Positive airway pressure therapy for the treatment of central sleep apnoea associated with heart failure.

Ischaemic heart disease including heart failure is the most common cause of death in the world, and the incidence of the condition is rapidly increasing. Heart failure is characterised by symptoms such as fatigue and breathlessness during light activity, as well as disordered breathing during sleep. In particular, sleep disordered breathing (SDB), including central sleep apnoea (CSA) and obstructive sleep apnoea (OSA), is highly prevalent in people with chronic heart failure. A previous meta-analysis demonstrated that positive airway pressure (PAP) therapy dramatically increased the survival rate of people with heart failure who had CSA, and thus could contribute to improving the prognosis of these individuals. However, recent trials found that adaptive servo-ventilation (ASV) including PAP therapy had a higher risk of all-cause mortality and cardiovascular mortality. A meta-analysis that included recent trials was therefore needed. To assess the effects of positive airway pressure therapy for people with heart failure who experience central sleep apnoea. We searched the Cochrane Central Register of Controlled Trials (CENTRAL) in the Cochrane Library, MEDLINE, Embase, and Web of Science Core Collection on 7 February 2019 with no limitations on date, language, or publication status. We also searched two clinical trials registers in July 2019 and checked the reference lists of primary studies. We excluded cross-over trials and included individually randomised controlled trials, reported as full-texts, those published as abstract only, and unpublished data. Two review authors independently extracted outcome data from the included studies. We double-checked that data had been entered correctly by comparing the data presented in the systematic review with study reports. We analysed dichotomous data as risk ratios (RRs) with 95% confidence intervals (CIs) and continuous data as mean difference (MD) or standardised mean difference (SMD) with 95% CIs. Furthermore, we performed subgroup analysis in the ASV group or continuous PAP group separately. We used GRADEpro GDT software to assess the quality of evidence as it relates to those studies that contribute data to the meta-analyses for the prespecified outcomes. We included 16 randomised controlled trials involving a total of 2125 participants. The trials evaluated PAP therapy consisting of ASV or continuous PAP therapy for 1 to 31 months. Many trials included participants with heart failure with reduced ejection fraction. Only one trial included participants with heart failure with preserved ejection fraction. We are uncertain about the effects of PAP therapy on all-cause mortality (RR 0.81, 95% CI 0.54 to 1.21; participants = 1804; studies = 6; I2 = 47%; very low-quality evidence). We found moderate-quality evidence of no difference between PAP therapy and usual care on cardiac-related mortality (RR 0.97, 95% CI 0.77 to 1.24; participants = 1775; studies = 5; I2 = 11%). We found low-quality evidence of no difference between PAP therapy and usual care on all-cause rehospitalisation (RR 0.95, 95% CI 0.70 to 1.30; participants = 1533; studies = 5; I2 = 40%) and cardiac-related rehospitalisation (RR 0.97, 95% CI 0.70 to 1.35; participants = 1533; studies = 5; I2 = 40%). In contrast, PAP therapy showed some indication of an improvement in quality of life scores assessed by all measurements (SMD -0.32, 95% CI -0.67 to 0.04; participants = 1617; studies = 6; I2 = 76%; low-quality evidence) and by the Minnesota Living with Heart Failure Questionnaire (MD -0.51, 95% CI -0.78 to -0.24; participants = 1458; studies = 4; I2 = 0%; low-quality evidence) compared with usual care. Death due to pneumonia (N = 1, 3% of PAP group); cardiac arrest (N = 18, 3% of PAP group); heart transplantation (N = 8, 1% of PAP group); cardiac worsening (N = 3, 9% of PAP group); deep vein thrombosis/pulmonary embolism (N = 1, 3% of PAP group); and foot ulcer (N = 1, 3% of PAP group) occurred in the PAP therapy group, whereas cardiac arrest (N = 16, 2% of usual care group); heart transplantation (N = 12, 2% of usual care group); cardiac worsening (N = 5, 14% of usual care group); and duodenal ulcer (N = 1, 3% of usual care group) occurred in the usual care group across three trials. The effect of PAP therapy on all-cause mortality was uncertain. In addition, although we found evidence that PAP therapy did not reduce the risk of cardiac-related mortality and rehospitalisation, there was some indication of an improvement in quality of life for heart failure patients with CSA. Furthermore, the evidence was insufficient to determine whether adverse events were more common with PAP than with usual care. These findings were limited by low- or very low-quality evidence. PAP therapy may be worth considering for individuals with heart failure to improve quality of life.