Increased respiratory disturbance index measured using an advanced device algorithm is associated with heart failure development.

Previous studies suggested that sleep-disordered breathing was associated with cardiovascular diseases such as heart failure (HF). Recently, algorithms of cardiac implantable electronic devices (CIEDs) have been developed to detect advanced sleep apnea (SA); the Apnea Scan (AP Scan) being an example. The purpose of this study was to investigate the association between respiratory disturbance index (RDI) measured using the AP Scan algorithm and HF development. We retrospectively studied consecutive patients with CIEDs equipped with the AP Scan algorithm which were implanted between December 1, 2011 and March 31, 2019. These patients were divided into 2 groups according to the trends of RDI: patients with a continually high RDI > 30 (severe SA group) and those without a continually high RDI (non-severe SA group). There were 16 and 46 patients in the severe and non-severe SA groups, respectively. Increased left ventricular end-diastolic and end-systolic dimensions were observed in the severe SA group. Regarding cardiovascular events, HF was observed in 8 patients (50.0%) in the severe SA group and 1 patient (2.2%) in the non-severe SA group; thus, there was a significantly higher proportion of patients with HF in the severe SA group. In conclusion, continually high RDI was associated with HF development in patients with CIEDs equipped with the AP Scan algorithm. Therefore, an elevated RDI may be a risk factor for the development of HF in patients with CIEDs.

Validity analysis of respiratory events of polysomnography using a plethysmography chest and abdominal belt.

PURPOSE: Respiratory inductive plethysmography (RIP) is recommended as an alternative respiratory sensor for the identification of each apnea and hypopnea event in polysomnography. Using this sensor, the cumulative RIP results from the chest and abdomen (RIP sum) and time-derived results of the RIP sum (RIP flow) are calculated to track respiratory flow. However, the effectiveness of this sensor and the calculated respiratory results is still unclear, and validation studies for the scoring of respiratory events in polysomnography are rare. METHODS: Two hundred subjects were selected according to the severity of obstructive sleep apnea. A sleep specialist re-evaluated the respiratory events based on RIP flow data in a single-blind study. Statistical analysis was conducted with paired respiratory events scored in each of the RIP flow and polysomnography datasets. RESULTS: All respiratory events scored from the RIP flow were strongly correlated with those identified with standard sensors of polysomnography, regardless of disease severity. Most of the respiratory parameters from RIP flow trended toward underestimation. The RIP flow obtained from the alternative RIP sensor was appropriate for the diagnosis of obstructive sleep apnea based on a receiver operating characteristic curve. CONCLUSIONS: Scored respiratory events from RIP flow data effectively reflected the respiratory flow and statistically correlated with the results from standard polysomnography sensors. Therefore, analyzing RIP flow utilizing an RIP sensor is considered a reliable method for respiratory event scoring.

Evaluation of thoracic impedance trends for implant-based remote monitoring in heart failure patients - Results from the (J-)HomeCARE-II Study.

AIMS: Remote monitoring by implantable devices substantially improves management of heart failure (HF) patients by providing diagnostic day-to-day data. The use of thoracic impedance (TI) as a surrogate measure of fluid accumulation is still strongly debated. The multicenter HomeCARE-II study evaluated clinically apparent HF events in the context of remote device diagnostics, focusing on the controversial role of TI. METHODS AND RESULTS: We followed 497 patients (66.6 ±â€¯10.1 years, 77% male, QRS 139.8 ±â€¯36.0 ms, ejection fraction 26.8 ±â€¯7.0%) implanted with a CRT-D (67%) or an ICD (33%) for 21.4 ±â€¯8.1 months. An independent event committee confirmed 171 HF events of which 82 were used to develop a TI-based algorithm for the prediction of imminent cardiac decompensation. Highly inter-individual variations in patterns of TI trends were observed. The algorithm resulted in a sensitivity of 41.5% (50.0%) with 0.95 (1.34) false alerts per patient year, and a positive predictive value of 7.9% overall and 27.9% in the HF event group of patients. Averaged ratio statistics showed a significant pre-hospital decrease and a highly significant in-hospital increase in TI after intensified diuresis. Recurrent decompensations turned out to be preceded by a significantly stronger decrease of TI compared to first events with a higher chance for detection (63.6% sensitivity, p < 0.05). CONCLUSIONS: Overall performance in predicting imminent decompensation by monitoring TI alone is limited due to its high inter-patient variability. TI stand-alone applications should be redirected towards a target population with more advanced symptoms where post-hospital observation aimed to maintain the patient's discharge status might be the most valuable approach. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT00711360 (HomeCARE-II) and NCT01221649 (J-HomeCARE-II).

Maternal cardiovascular hemodynamics in normotensive versus preeclamptic pregnancies: a prospective longitudinal study using a noninvasive cardiac system (NICaS™).

BACKGROUND: Preeclampsia is among the most common medical complications of pregnancy. The clinical utility of invasive hemodynamic monitoring in preeclampsia (e.g., Swan-Ganz catheter) is controversial. Thoracic impedance cardiography (TIC) and Doppler echocardiography are noninvasive techniques but they both have important limitations. NICaS™ (NI Medical, PetachTikva, Israel) is a noninvasive cardiac system for determining cardiac output (CO) that utilizes regional impedance cardiography (RIC) by noninvasively measuring the impedance signal in the periphery. It outperformed any other impedance cardiographic technology and was twice as accurate as TIC. METHODS: We used the NICaS™ system to compare the hemodynamic parameters of women with severe preeclampsia (PET group, n = 17) to a cohort of healthy normotensive pregnant women with a singleton pregnancy at term (control group, n = 62) (1/2015-6/2015). Heart rate (HR), stroke volume (SV), CO, total peripheral resistance (TPR) and mean arterial pressure (MAP) were measured 15-30 min before CS initiation, immediately after administering spinal anesthesia, immediately after delivery of the fetus and placenta, at the abdominal fascia closure and within 24-36 and 48-72 h postpartum. RESULTS: The COs before and during the CS were significantly higher in the control group compared to the PET group (P < .05), but reached equivalent values within 24-36 h postpartum. CO peaked at delivery of the newborn and the placenta and started to decline afterwards in both groups. The MAP and TPR values were significantly higher in the PET group at all points of assessment except at 48-72 h postpartum when it was still significantly higher for MAP while the TPR only exhibited a higher trend but not statistically significant. The NICaS™ device noninvasively demonstrated low CO and high TPR profiles in the PET group compared to controls. CONCLUSIONS: The immediate postpartum period is accompanied by the most dramatic hemodynamic changes and fluid shifts, during which the parturient should be closely monitored. The NICaS™ device may help the clinician to customize the most optimal management for individual parturients. Our findings require validation by further studies on larger samples.

Pacemaker-detected severe sleep apnea predicts new-onset atrial fibrillation.

AIMS: Sleep apnea (SA) diagnosed on overnight polysomnography is a risk factor for atrial fibrillation (AF). Advanced pacemakers are now able to monitor intrathoracic impedance for automatic detection of SA events. METHODS AND RESULTS: We enrolled 160 consecutive recipients of a dual-chamber pacemaker endowed with the ApneaScan algorithm (Boston Scientific). If the pacemaker-measured Respiratory Disturbance Index was ≥30 episodes per hour for at least one night during the first week after implantation, SA was defined as severe. Patients were considered to have experienced AF episodes if the device detected a cumulative AF burden ≥6 h in a day. Sixteen patients in AF at the time of implantation were excluded from our analysis. During follow-up, AF burden ≥6 h/day was documented in 35 (24%) of the patients included in the analysis and in 12 (13%) of the 96 patients with no history of AF. Severe SA was detected in 89 patients during the first week after implantation; 58 of these had no history of AF. Severe SA at the baseline was associated with a higher risk of AF both in the whole population (log-rank test, hazard ratio: 2.38; 95% CI: 1.21-4.66; P = 0.025) and among patients with no previous history of AF (log-rank test, hazard ratio: 2.80; 95% CI: 1.10-7.10; P = 0.047). Moreover, severe SA at the time of follow-up device interrogation predicted AF occurrence within the next 3 months (log-rank test, hazard ration: 2.13; 95% CI: 1.11-4.08; P = 0.036). CONCLUSIONS: In pacemaker patients, device-diagnosed severe SA was independently associated with a higher risk of AF (≥6 h/day) and new-onset AF. In particular, severe SA on follow-up data review identified patients who were ∼2-fold more likely to experience an AF episode in the next 3 months.

Non-invasive measurement of cardiac output using AESCULON® mini after Fontan operation.

BACKGROUND: Electrical velocimetry correlates well with established methods of measuring cardiac output (CO) such as thermodilution and echocardiography. In this study, we compared the cardiac function of children with single right ventricle (SRV) and single left ventricle (SLV) on non-invasive postoperative measurement of hemodynamic parameters using AESCULON® mini. METHODS: Demographic, preoperative, and perioperative data were obtained from medical records. We retrospectively reviewed the AESCULON mini data of 21 patients with single ventricle who underwent Fontan operation. The patients were divided into two groups according to morphologic diagnosis: SRV (n = 9) and SLV (n = 12). The following hemodynamic parameters were analyzed: stroke volume (SV); CO; cardiac index (CI); stroke volume variation (SVV); and ventricular ejection time (VET). RESULTS: Hemodynamic parameters were as follows (SRV vs SLV): heart rate (HR), 140.5 beats/min versus 121 beats/min; SV, 14.5 mL vs 19.9 mL; CO, 2 L/min vs 2.3 L/min; CI, 4.3 L/min/m2 versus 4.4 L/min/m2 ; SVV, 15.5% versus 13.9%; and VET, 167.7 s versus 197.7 s. HR and VET were statistically different between the two groups. CONCLUSIONS: CI does not differ with laterality of the single ventricle. SRV VET, however, was significantly shorter than SLV VET in the acute postoperative period. Conversely, SRV HR was higher than SLV HR, which may mean that SRV compensates for lower VET by increasing HR.

Cardiac Output Assessment by Transthoracic Electrical Bio-impedance in Patients of Acute Myocardial Infarction: Comparative Analysis with Echocardiography.

Objectives: Transthoracic electrical bio-impedance (TEB) has been proposed as a non-invasive and continuous method of cardiac output (CO) measurement, but it still has not found wide usages in clinics. The present study measured CO, using a new instrument NICOMON, and compared it with Echocardiography (ECHO) in acute myocardial infarction (AMI) patients. Methods: In the present study 100 patients of AMI were assessed by both ECHO and NICOMON for cardiac output and ECHO is considered as a reference method for comparison. TEB CO was measured by passing an alternating current and measuring the bio-impedance across the thorax. End diastolic volume (EDV), End systolic volume (ESV) & Left ventricular outflow tract (LVOT) diameter, measured by ECHO were used to calculate CO. Various statistical methods like "t"-test & correlation coefficient (r) were used where found suitable. Results: Results: Mean TEB-CO (4.03±1.11 l/min) was significantly higher (p<0.001) than mean ECHO-CO (3.80±1.28 l/min) with a mean difference of 0.25±1.02 l/min. Conclusions: NICOMON measures CO non-invasively but, it needs more elaborative studies on a larger sample to establish it as an alternative method of ECHO for cardiac output measurement on regular basis.

Making sense of clinical outcomes following cardiac arrest.

PURPOSE OF REVIEW: To provide a summary of the recent literature on clinical outcomes in adults with cardiac arrest, focusing on the impact of patient-specific factors in combination with cardio-pulmonary resuscitation (CPR) related, and postresuscitative-related factors. RECENT FINDINGS: Cardiac arrest is a major cause of morbidity and mortality worldwide. Despite the use of conventional cardiopulmonary resuscitation, rates of return of spontaneous circulation and survival with minimal neurologic impairment remain low. A number of recent studies have examined the impact of patient-specific factors (duration of cardiac arrest, initial rhythm, age, premorbid states), CPR-related (the use of mechanical CPR, the use of impedance threshold device, vasopressors, extra-corporeal membrane oxygenation, active compression-decompression, and impedance threshold device), and postresuscitative-related factors (hypothermia, coronary angiography, hyperoxia, hyper/hypocapnia, mean arterial blood pressure) on cardiac arrest outcomes. SUMMARY: Further studies, namely randomized controlled trials, assessing the impact of advanced therapies are warranted to evaluate their impact on survival and neurologic function in adults with cardiac arrest.

Decreased Intrathoracic Impedance Associated With OptiVol Alert Can Diagnose Increased B-Type Natriuretic Peptide - MOMOTARO (Monitoring and Management of OptiVol Alert to Reduce Heart Failure Hospitalization) Study - .

BACKGROUND: Ambulatory measurement of intrathoracic impedance (ITI) with an implanted device may detect increases in pulmonary fluid retention early, but the clinical utility of this method is not well established. The goal of this study was to test whether conventional ITI-derived parameters can diagnose fluid retention that may cause early stage heart failure (HF). METHODS AND RESULTS: HF patients implanted with high-energy devices with OptiVol (Medtronic) monitoring were enrolled in this study. Patients were monitored remotely. At both baseline and OptiVol alert, patients were assessed on standard examinations, including analysis of serum brain natriuretic peptide (BNP). From April 2010 to August 2011, 195 patients from 12 institutes were enrolled. There were 154 primary OptiVol alert events. BNP level at the alerts was not significantly different from that at baseline. Given that ITI was inversely correlated with log BNP, we added a criterion specifying that the OptiVol alert is triggered only when ITI decreases by ≥4% from baseline. This change improved the diagnostic potential of increase in BNP at OptiVol alert (sensitivity, 75%; specificity, 88%). CONCLUSIONS: BNP increase could not be identified based on OptiVol alert. Decrease in ITI ≥4% compared with baseline, in addition to the alert, however, may be a useful marker for the likelihood of HF (Clinical trial info: UMIN000003351).

A Novel Noninvasive Device to Assess Sympathetic Nervous System Function in Patients With Heart Failure.

BACKGROUND: Heart failure is a complex syndrome associated with sympathetic nervous system and renin-angiotensin-aldosterone system hyperactivity. Sympathoinhibition and downregulation of sympathetic activity using medications and exercise training improve outcomes in patients with heart failure. Impedance cardiography provides data on hemodynamic and autonomic function that may assist with safe medication, exercise monitoring, and titration. PURPOSE: The purpose of this pilot study was to evaluate the sensitivity of the Vrije Universiteit Ambulatory Monitoring System (VU-AMS) version 5fs to detect hemodynamic and sympathetic nervous system changes associated with postural shift in persons with heart failure with reduced ejection fraction. METHODS: In this descriptive study, participants (N = 28) were recruited from an outpatient device clinic at a tertiary care hospital in Ontario, Canada. They completed a sit-to-stand posture protocol wearing an ambulatory blood pressure (ABP) and a noninvasive VU-AMS version 5fs impedance cardiography system. RESULTS: Most (n = 18, 64%) participants were eliminated from the final analyses in this sample because of difficulty in Q-onset and B-point identification in peculiar electrocardiogram and impedance cardiogram waveforms. The remaining participants (n = 10) had a mean age of 69 years (SD = 10 years) and responses to a sit-to-stand posture protocol that included a 5% increase in heart rate (p = .001), an 18% decrease in stroke volume (p = .01), and an 8% decrease in left ventricular ejection time (p = .01). Participants had an increased preejection period (11%, p = .01), a drop in cardiac output of 13% (p = .02), and a reduced mean arterial pressure of approximately 4% (p = .09) with standing. DISCUSSION: Although the VU-AMS version 5fs system detected anticipated hemodynamic and sympathetic nervous system changes to postural shift in participants (n = 10), the elimination of 64% (n = 18) of the sample because of scoring difficulties limits the use of this impedance cardiography device using standard scoring algorithms in persons with heart failure with reduced ejection fraction.

Validation of stroke volume and cardiac output by electrical interrogation of the brachial artery in normals: assessment of strengths, limitations, and sources of error.

The goal of this study is to validate a new, continuous, noninvasive stroke volume (SV) method, known as transbrachial electrical bioimpedance velocimetry (TBEV). TBEV SV was compared to SV obtained by cardiac magnetic resonance imaging (cMRI) in normal humans devoid of clinically apparent heart disease. Thirty-two (32) volunteers were enrolled in the study. Each subject was evaluated by echocardiography to assure that no aortic or mitral valve disease was present. Subsequently, each subject underwent electrical interrogation of the brachial artery by means of a high frequency, low amplitude alternating current. A first TBEV SV estimate was obtained. Immediately after the initial TBEV study, subjects underwent cMRI, using steady-state precession imaging to obtain a volumetric estimate of SV. Following cMRI, the TBEV SV study was repeated. Comparing the cMRI-derived SV to that of TBEV, the two TBEV estimates were averaged and compared to the cMRI standard. CO was computed as the product of SV and heart rate. Statistical methods consisted of Bland-Altman and linear regression analysis. TBEV SV and CO estimates were obtained in 30 of the 32 subjects enrolled. Bland-Altman analysis of pre- and post-cMRI TBEV SV showed a mean bias of 2.87 % (2.05 mL), precision of 13.59% (11.99 mL) and 95% limits of agreement (LOA) of +29.51% (25.55 mL) and -23.77% (-21.45 mL). Regression analysis for pre- and post-cMRI TBEV SV values yielded y = 0.76x + 25.1 and r(2) = 0.71 (r = 0.84). Bland-Altman analysis comparing cMRI SV with averaged TBEV SV showed a mean bias of -1.56% (-1.53 mL), precision of 13.47% (12.84 mL), 95% LOA of +24.85% (+23.64 mL) and -27.97% (-26.7 mL) and percent error = 26.2 %. For correlation analysis, the regression equation was y = 0.82x + 19.1 and correlation coefficient r(2) = 0.61 (r = 0.78). Bland-Altman analysis of averaged pre- and post-cMRI TBEV CO versus cMRI CO yielded a mean bias of 5.01% (0.32 L min(-1)), precision of 12.85% (0.77 L min(-1)), 95% LOA of +30.20 % (+0.1.83 L min(-1)) and -20.7% (-1.19 L min(-1)) and percent error = 24.8%. Regression analysis yielded y = 0.92x + 0.78, correlation coefficient r(2) = 0.74 (r = 0.86). TBEV is a novel, noninvasive method, which provides satisfactory estimates of SV and CO in normal humans.

Nonhemodynamic parameters from implantable devices for heart failure risk stratification.

"Implantable devices are well suited to monitor and record several parameters that carry prognostic information. Specifically, the primary function of implantable cardioverter defibrillators (ICDs) is to monitor for changes in heart rhythm and treat both tachyarrhythmias and bradyarrhythmias. They are efficient in monitoring the heart rate, incidence of arrhythmias, and patient activity level, which provide prognostic information. Parameters such as thoracic impedance, heart sounds, and respiratory rate and patterns may further refine prognostic information available from ICDs. Combining parameters may provide a better way to interpret and use the available information."

Assessment of intrathoracic impedance algorithm in the pediatric and adult congenital population.

BACKGROUND: Decreased intrathoracic impedance has been used in adults to predict heart failure (HF) exacerbations. A commercial algorithm, OptiVol® (Medtronic Inc., Minneapolis, MN, USA), identifies patients with decreased impedance. We sought to determine the specificity, sensitivity, and positive predictive value (PPV) of OptiVol for predicting HF exacerbation or increased arrhythmia burden in pediatric and adult congenital heart disease (CHD) patients. METHODS: A multicenter retrospective chart review was undertaken. Inclusion criteria were: (1) <19 years or CHD adults, (2) an implanted device with OptiVol capability, (3) implanted between April 9 and September 6, and (4) follow-up of >30 days postimplant. Clinical events were defined as clinical HF exacerbation/hospital admission, initiation/uptitration of medication, or increased arrhythmia burden. RESULTS: Seventy-two patients (19 ± 9 years) were identified with the following indications: 20% dilated cardiomyopathy (DCM), 11% hypertrophic cardiomyopathy (HCM), 43% CHD, 15% channelopathy, and 11% other. Thirty-nine had 122 OptiVol crossings (median 2, range 1-11); 30% were linked to a cause. The remaining 33 had no crossing, though 17 had 89 clinical events. The clinical event rate was 19% greater in patients with crossings, though not statistically significant (P = 0.4). The algorithm had a 59% sensitivity, 52% specificity, and 62% PPV. Clinical HF exacerbation and arrhythmia burden did not significantly correlate with decreased impedance though uptitration or initiation of HF medication did correlate significantly (P = 0.03). CONCLUSION: The algorithm sensitivity for pediatric DCM, HCM, CHD, and adult CHD was equivalent to the general adult population. Further studies are warranted to assess whether inaccuracy in prediction is secondary to the algorithm or to differences in the clinical response of pediatric/CHD patients.

Parasympathetic nervous system activity and children's sleep.

We examined indices of children's parasympathetic nervous system activity (PNS), including respiratory sinus arrhythmia during baseline (RSAB) and RSA reactivity (RSAR), to a laboratory challenge, and importantly the interaction between RSAB and RSAR as predictors of multiple parameters of children's sleep. Lower RSAR denotes increased vagal withdrawal (reductions in RSA between baseline and task) and higher RSAR represents decreased vagal withdrawal or augmentation (increases in RSA between baseline and task). A community sample of school-attending children (121 boys and 103 girls) participated [mean age = 10.41 years; standard deviation (SD) = 0.67]. Children's sleep parameters were examined through actigraphy for 7 consecutive nights. Findings demonstrate that RSAB and RSAR interact to predict multiple sleep quality parameters (activity, minutes awake after sleep onset and long wake episodes). The overall pattern of effects illustrates that children who exhibit more disrupted sleep (increased activity, more minutes awake after sleep onset and more frequent long wake episodes) are those with lower RSAB in conjunction with lower RSAR. This combination of low RSAB and low RSAR probably reflects increased autonomic nervous system arousal, which interferes with sleep. Results illustrate the importance of individual differences in physiological regulation indexed by interactions between PNS baseline activity and PNS reactivity for a better understanding of children's sleep quality.

[Applicability of the two-compartment coaxial cylindrical model for ambulatory measuring of cardiac output with spot-electrodes].

The principle of ambulatory cardiac output (CO) measuring technique is introduced in this paper. Experimental studies about the applicability of the two-compartment coaxial cylindrical model for ambulatory measurement of cardiac output with spot-electrodes have been carried out with using our newly-developed multi-channel impedance mapping system. The key factors using a spot-electrode array instead of a conventional band-electrode array for non-invasive CO) measurement are elaborated. The variations of the electric impedance pulsatile component (deltaZ waveform) and the two kinds of typical modes of deltaZ distributions measured by six electrodes on the midsternal (midian) line from the medial portion at the level of clavicle to the portion above the xiphisternum are discussed. The applicability of the two-compartment coaxial cylindrical model for ambulatory measurement of CO with spot-electrodes is analyzed. Synthesizing the deltaZ distributions and their typical changing models on the midsternal (midian) line during blood inflowing into aorta is the optimal positions of a pair of spot-electrodes for voltage pick-up at the level of clavicle for the upper electrode and the position at the level of nipple for the lower electrode when spot-electrode is being used to measure non-invasive CO.

Clinical evaluation of a new tracheal impedance cardiography method.

Non-invasive cardiac output measurement by means of impedance cardiography has been evaluated before, and agreement with other methods has been variable. We decided to study a newly developed tracheal impedance device, that is claimed to be more accurate and reliable. This incorporates new software and mathematical formulae, that are designed to reduce signal noise from diathermy, leading to improved accuracy. In 25 cardiothoracic surgery patients, simultaneous measurements were performed using both pulmonary artery thermodilution and the tracheal impedance device, at five peri-operative time points: before skin incision; after weaning from cardiopulmonary bypass; after sternal closure; and 30 min and 2 h after arrival in the intensive care unit. Mean cardiac output, bias and 95% limits of agreement were 5.3, 0.03 and -2.8 to 2.8 l.min(-1) , respectively. Tracheal impedance showed good correlation with measurement trends using thermodilution in 88% of measurements, with a mean (95% limit of agreement) angular bias of -9.0° (-83.3 to 65.3°). However, the wide limits of agreement and high percentage error of 53% that were apparent in this study mean that, in its present guise, tracheal impedance is not an acceptable alternative to thermodilution in cardiac surgical patients.

Multi-modal ECG Holter system for sleep-disordered breathing screening: a validation study.

BACKGROUND: The high prevalence of sleep disordered breathing (SDB) among heart diseases patients becomes increasingly recognized. A reliable exploring tool of SDB well adapted to cardiologists practice would be very useful for the management of these patients. METHODS: We assessed a novel multi-modal electrocardiogram (ECG) Holter which incorporated both thoracic impedance and pulse oximetry signals. We compared in a home setting, a standard condition for Holter recordings, results from the novel device to a classical ambulatory polygraph in subjects with suspected SDB. The analysis of cardiac arrhythmias in relationship with SDB is also presented. A total of 118 patients clinically suspected of having SDB were evaluated (mean age 57 ± 14 years, mean body mass index [BMI] 32 ± 6 kg/m(2)). The new device allows calculating a new index called thoracic impedance (TI) disturbance index (TIDI+) evaluated from TI and SpO(2) signals recorded from a Holter monitor. RESULTS: In the population under study, 93% had more than 70% of usable TI signal and 95% had more than 90% for SpO(2) during sleep time recording. Screening performance results based on automatic analysis is accurate: TIDI + demonstrates a high level of sensitivity (96.8%), specificity (72.3%) as well as positive (82.4%) and negative (94.4%) predictive value for the detection of SDB. Moreover, detection of SDB periods permits us to observe a possible respiratory association of several nocturnal arrhythmias. CONCLUSIONS: The multi-modal Holter should be considered as a valuable evaluating tool for SDB screening and as a case selection technique for facilitating access to a full polysomnography for severe cases. Moreover, it offers a unique opportunity to study arrhythmia consequences with both respiratory and hypoxia disturbances.

Implantable cardiovascular sensors and computers: interventional heart failure strategies.

Despite evidence-based medical and pharmacologic advances the management of heart failure remains challenging, whether in the ambulatory setting where daily weight monitoring has failed, or in the inpatient setting where readmission rates and morbidity remains high. There is an urgent need to develop strategies to reduce hospitalizations and readmission rates for heart failure in general. There may be a shift in the paradigm with respect to the treatment of heart failure, which may usher in an era of invasive heart failure therapies and specialists. Experimental invasive devices and monitors have the potential to be game-changing therapies, and cardiac resynchronization therapy has evolved beyond just resynchronization and has the potential to provide important real-time hemodynamic feedback.

Sensitivity and positive predictive value of implantable intrathoracic impedance monitoring as a predictor of heart failure hospitalizations: the SENSE-HF trial.

AIMS: Early recognition of impending decompensation and timely intervention may prevent heart failure (HF) hospitalization. We investigated the performance of OptiVol® intrathoracic fluid monitoring for the prediction of HF events in chronic HF patients newly implanted with a device (implantable cardioverter-defibrillator with or without cardiac resynchronization therapy). METHODS AND RESULTS: SENSE-HF was a prospective, multi-centre study that enrolled 501 patients. Phase I (double blinded, 6 months) determined the sensitivity and positive predictive value (PPV) of the OptiVol data in predicting HF hospitalizations. Of 58 adjudicated HF hospitalizations that occurred during the first 6 months in Phase I, 12 were predicted by OptiVol (sensitivity = 20.7%). Sensitivity appeared to be dynamic in nature and at the end of Phase I, had increased to 42.1%. With 253 OptiVol detections, PPV for Phase I was 4.7%. Phase II/III (unblinded, 18 months) determined the PPV of the first OptiVol Patient Alert for detection of worsening HF status with signs and/or symptoms of pulmonary congestion. A total of 233 patients noted such an OptiVol alert and for 210, HF status was evaluated within 30 days. Heart failure status had worsened for 80 patients (PPV = 38.1%). CONCLUSIONS: An intrathoracic impedance-derived fluid index had low sensitivity and PPV in the early period after implantation of a device in chronic HF patients. Sensitivity improved within the first 6 months after implant. Further studies are needed to assess the place of this monitoring technology in the clinical management of patients with HF.

Temporal associations between thoracic volume overload and malignant ventricular arrhythmias: a study of intrathoracic impedance.

BACKGROUND: Acute exacerbations of heart failure (HF) are believed to trigger malignant ventricular arrhythmias, but the temporal association between fluid accumulation and ventricular arrhythmias has not been evaluated in an objective manner. We hypothesized that increased intrathoracic fluid accumulation in patients with HF, as measured by an index of intrathoracic impedance, is associated with an increased risk of ventricular arrhythmias. METHODS AND RESULTS: We analyzed interrogations in a cohort of 96 patients with left ventricular dysfunction (EF ≤ 35%) with devices that monitor intrathoracic impedance (OptiVol fluid index). Treated episodes of ventricular tachycardia or fibrillation (VT/VF) were adjudicated and stratified according to predetermined fluid index thresholds (OptiVol indices of 15, 30, 45, 60 Ω-days). VT/VF episodes occurred in 16 patients (17%). VT/VF was more common on days when the fluid index was elevated using threshold values of 15, 30, and 45 Ω-days (P = 0.006, 0.04, 0.02, respectively). There were no differences in the percent of time above any threshold between patients with and without VT/VF. CONCLUSIONS: In patients with HF who develop VT/VF, volume overload, as detected by an index incorporating changes in intrathoracic impedance, was temporally associated with malignant ventricular tachyarrhythmias.