Ineffective Cardiac Resynchronization Pacing is Associated with Poor Outcomes in a Nationwide Cohort Analysis.

BACKGROUND: Delivery of cardiac resynchronization therapy (CRT) requires left ventricular myocardial capture to achieve clinical benefits. OBJECTIVE: We sought to determine whether ineffective pacing impacts survival. METHODS: Ineffective ventricular pacing (VP) was defined as the difference between percent delivered CRT (%VP) and percent EffectivCRTTM in CRT devices. Using the Optum® de-identified Electronic Health Record dataset (Optum® EHR) and Medtronic CareLinkTM data warehouse, we identified patients implanted with applicable devices with at least 30 days follow-up. Kaplan-Meier and Cox proportional hazards models assessed the impact of %VP and % ineffective VP on survival. RESULTS: Among 7,987 patients with 2.1±1.0 years follow up, increasing ineffective VP was associated with decreasing survival: the highest observed survival was in the quartile with <0.08% ineffective VP and the lowest survival was in the quartile with >1.47% ineffective VP (85.1% vs. 75.7% at 3 years, p<0.001). As expected, patients with more than the median %VP of 97.7% had better survival than patients with <97.7% VP (84.2% vs. 77.8%, p < 0.001). However, patients that had >97.7% VP but >2% ineffective VP had similar survival to patients with <97.7% VP but ≤2% ineffective VP (81.6% vs 79.4%, p = 0.54). A multivariable Cox proportional hazards model demonstrated that <97.7% VP (adjusted HR 1.29; 95% CI 1.14-1.46; p <0.001) and >2% ineffective VP (HR 1.35; 95% CI 1.18-1.54; p<0.001) were both significantly associated with decreased survival. CONCLUSIONS: Ineffective VP is associated with decreased survival. In addition to maximizing the percentage of delivered CRT pacing, every effort should be made to minimize ineffective VP.

Noninvasive Electrical Mapping Compared with the Paced QRS Complex for Optimizing CRT Programmed Settings and Predicting Multidimensional Response.

The aim was to test the hypothesis that left ventricular (LV) and right ventricular (RV) activation from body surface electrical mapping (CardioInsight 252-electrode vest, Medtronic) identifies optimal cardiac resynchronization therapy (CRT) pacing strategies and outcomes in 30 patients. The LV80, RV80, and BIV80 were defined as the times to 80% LV, RV, or biventricular electrical activation. Smaller differences in the LV80 and RV80 (|LV80-RV80|) with synchronized LV pacing predicted better LV function post-CRT (p = 0.0004) than the LV-paced QRS duration (p = 0.32). Likewise, a lower RV80 was associated with a better pre-CRT RV ejection fraction by CMR (r = - 0.40, p = 0.04) and predicted post-CRT improvements in myocardial oxygen uptake (p = 0.01) better than the biventricular-paced QRS (p = 0.38), while a lower LV80 with BIV pacing predicted lower post-CRT B-type natriuretic peptide (BNP) (p = 0.02). RV pacing improved LV function with smaller |LV80-RV80| (p = 0.009). In conclusion, 3-D electrical mapping predicted favorable post-CRT outcomes and informed effective pacing strategies.

First-in-human noninvasive left ventricular ultrasound pacing: A potential screening tool for cardiac resynchronization therapy.

Background: A screening tool to predict response to cardiac resynchronization therapy (CRT) could improve patient selection and outcomes. Objective: The purpose of this study was to investigate the feasibility and safety of noninvasive CRT via transcutaneous ultrasonic left ventricular (LV) pacing applied as a screening test before CRT implants. Methods: P-wave-triggered ultrasound stimuli were delivered during bolus dosing of an echocardiographic contrast agent to simulate CRT noninvasively. Ultrasound pacing was delivered at a variety of LV locations with a range of atrioventricular delays to achieve fusion with intrinsic ventricular activation. Three-dimensional cardiac activation maps were acquired via the Medtronic CardioInsight 252-electrode mapping vest during baseline, ultrasound pacing, and after CRT implantation. A separate control group received only the CRT implants. Results: Ultrasound pacing was achieved in 10 patients with a mean of 81.2 ± 50.8 ultrasound paced beats per patient and up to 20 consecutive beats of ultrasound pacing. QRS width at baseline (168.2 ± 17.8 ms) decreased significantly to 117.3 ± 21.5 ms (P <.001) in the best ultrasound paced beat and to 125.8 ± 13.3 ms (P <.001) in the best CRT beat. Electrical activation patterns were similar between CRT pacing and ultrasound pacing with stimulation from the same area of the LV. Troponin results were similar between the ultrasound pacing and the control groups (P = .96), confirming safety. Conclusion: Noninvasive ultrasound pacing before CRT is safe and feasible, and it estimates the degree of electrical resynchronization achievable with CRT. Further study of this promising technique to guide CRT patient selection is warranted.

Prolonged PR interval and incidence of atrial fibrillation, heart failure admissions, and mortality in patients with implanted cardiac devices: A real-world survey.

Background: Prolongation of the PR interval has long been considered a benign condition, particularly in the setting of nonstructural heart disease. Objective: The purpose of this study was to investigate the effect of PR interval on various well-adjudicated cardiovascular outcomes using a large real-world population data of patients with implanted dual-chamber permanent pacemakers or implantable cardioverter-defibrillators. Methods: PR intervals were measured during remote transmissions in patients with implanted permanent pacemakers or implantable cardioverter-defibrillators. Study endpoints (time to the first occurrence of AF, heart failure hospitalization [HFH], or death) were obtained between January 2007 and June 2019 from the deidentified Optum de-identified Electronic Health Record dataset. Results: A total of 25,752 patients (age 69.3 ± 13.9 years; 58% male) were evaluated. The average intrinsic PR interval was 185 ± 55 ms. In the subset of 16,730 patients with available long-term device diagnostic data, a total of 2555 (15.3%) individuals developed AF during 2.59 ± 2.18 years of follow-up. The incidence of AF was significantly higher (up to 30%) in patients with a longer PR interval (ie, PR interval ≥270 ms; P < .05). Time-to-event survival analysis and multivariable analysis showed that PR interval ≥190 ms was significantly associated with higher incidence of AF, HFH, or HFH or death when compared with shorter PR intervals (P < .05 for all 3 parameters). Conclusion: In a large real-world population of patients with implanted devices, PR interval prolongation was significantly associated with increased incidence of AF, HFH, or death.

Validation of Intrinsic Left Ventricular Assist Device Data Tracking Algorithm for Early Recognition of Centrifugal Flow Pump Thrombosis.

Advanced stage heart failure patients can benefit from the unloading effects of an implantable left ventricular assist device. Despite best clinical practice, LVADs are associated with adverse events, such as pump thrombosis (PT). An adaptive algorithm alerting when an individual's appropriate levels in pump power uptake are exceeded, such as in the case of PT, can improve therapy of patients implanted with a centrifugal LVAD. We retrospectively studied 75 patients implanted with a centrifugal LVAD in a single center. A previously optimized adaptive pump power-tracking algorithm was compared to clinical best practice and clinically available constant threshold algorithms. Algorithm performances were analyzed in a PT group (n = 16 patients with 30 PT events) and a thoroughly selected control group (n = 59 patients, 34.7 patient years of LVAD data). Comparison of the adaptive power-tracking algorithm with the best performing constant threshold algorithm resulted in sensitivity of 83.3% vs. 86.7% and specificity of 98.9% vs. 95.3%, respectively. The power-tracking algorithm produced one false positive detection every 11.6 patient years and early warnings with a median of 3.6 days prior to PT diagnosis. In conclusion, a retrospective single-center validation study with real-world patient data demonstrated advantageous application of a power-tracking algorithm into LVAD systems and clinical practice.

A Power Tracking Algorithm for Early Detection of Centrifugal Flow Pump Thrombosis.

Logfiles from the HeartWare HVAD System provide operational pump trend data to aid in patient management. Pump thrombosis is commonly associated with increases in the logfile power that may precede the clinical presentation. A Power Tracking algorithm was developed to detect significant deviations in pump power that may be associated with pump thrombus (PT). The Power Tracking algorithm was applied retrospectively to logfiles captured in the ENDURANCE, ENDURANCE Supplemental, and LATERAL clinical trials. From a combined dataset of 896 patients, available logfiles with suspected PT (n = 70 events in 60 patients) and available logfiles from patients without adverse events (AEs) (n = 106 patients, consisting of 27.4 patient-years of monitoring) were organized into two cohorts. The Power Tracking algorithm detected PT cases on or before the recorded AE date with a sensitivity of 85.7%, with detection occurring an average of 3.9 days before clinical presentation. The algorithm averaged one false alarm for every 6.85 patient-years of monitoring from logfiles without AEs. The favorable performance of the Power Tracking algorithm may enable earlier detection of pump thrombosis and allow early medical management versus surgical intervention.

Adaptive cardiac resynchronization therapy is associated with decreased risk of incident atrial fibrillation compared to standard biventricular pacing: A real-world analysis of 37,450 patients followed by remote monitoring.

BACKGROUND: The AdaptivCRT algorithm (aCRT) automatically adjusts atrioventricular delays each minute to achieve ventricular fusion through left ventricular (LV) or biventricular (BiV) pacing. aCRT is associated with superior clinical outcomes compared to standard BiV pacing, but the association of aCRT and subsequent atrial fibrillation (AF) in a real-world population has not been fully evaluated. OBJECTIVE: The purpose of this study was to investigate the incidence of AF ≥48 hours with aCRT vs standard BiV pacing after implant. METHODS: Patients implanted with a cardiac resynchronization therapy (CRT) device between 2013 and 2016 were studied via the de-identified Medtronic CareLink database. For univariate and multivariate survival analyses, Kaplan-Meier and Cox proportional hazards were used, respectively. RESULTS: Of 37,450 patients (mean age 69.1 ± 11.0 years; 67.9% male) followed for a mean 15.5 ± 9.1 months, 9.7% (n = 3647) developed ≥48 hours of AF. In univariate analysis, compared with standard BiV pacing, the aCRT BiV and LV mode was associated with a 54% lower risk of ≥48 hours of AF (P <.001) at 2 years, which persisted after multivariate adjustment (hazard ratio 0.53; 95% confidence interval 0.49-0.57; P <.001), even when stratified by sensed PR interval ≤200 ms and >200 ms. Higher percentages of LV-only pacing with aCRT were associated with lower incidence of AF (comparing >92% LV-only pacing vs 0%-5% LV-only pacing: HR 0.05; 95% CI 0.04-0.06; P <.001). CONCLUSION: In a large, real-world population of CRT recipients, aCRT pacing compared to standard BiV pacing was associated with a lower incidence of AF in patients with both long and short PR intervals. A higher percentage of LV-only pacing during aCRT was also associated with lower incidence of AF.

A novel algorithm increases the delivery of effective cardiac resynchronization therapy during atrial fibrillation: The CRTee randomized crossover trial.

BACKGROUND: Cardiac resynchronization therapy (CRT) requires a high percentage of ventricular pacing (%Vp) to maximize its clinical benefits. Atrial fibrillation (AF) has been shown to reduce %Vp in CRT due to competition with irregular intrinsic atrioventricular (AV) conduction. We report the results of a prospective randomized crossover trial evaluating the amount of effective CRT delivered during AF with a novel algorithm (eCRTAF). OBJECTIVE: The purpose of this study was to determine whether eCRTAF increases the amount of effective CRT delivered during AF compared to a currently available rate regularization algorithm. METHODS: Patients previously implanted with a cardiac resynchronization therapy-defibrillator and with a history of AF and intact AV conduction received up to 4 weeks of control (Conducted AF Response) and up to 4 weeks of eCRTAF in a randomized sequence. The percent effective CRT (%eCRT) pacing, which excludes beats without left ventricular capture, %Vp, and mean heart rate (HR) were recorded during AF and sinus rhythm. RESULTS: The eCRTAF algorithm resulted in a significantly higher %eCRT during AF than control (87.8% ± 7.8% vs 80.8% ± 14.3%; P <.001) and %Vp during AF than control (90.0% ± 5.9% vs 83.2% ± 11.9%; P <.001), with a small but statistically significant increase in mean HR of 2.5 bpm (79.5 ± 9.7 bpm vs 77.0 ± 9.9 bpm; P <.001). CONCLUSION: In a cohort of CRT patients with a history of AF, eCRTAF significantly increased %eCRT pacing and %Vp during AF with a small increase in mean HR. This algorithm may represent a novel noninvasive method of significantly increasing effective CRT delivery during AF, potentially improving CRT response.

Influence of automatic frequent pace-timing adjustments on effective left ventricular pacing during cardiac resynchronization therapy.

AIMS: Cardiac resynchronization therapy (CRT) requires effective left ventricular (LV) pacing (i.e. sufficient energy and appropriate timing to capture). The AdaptivCRT™ (aCRT) algorithm serves to maintain ventricular fusion during LV or biventricular pacing. This function was tested by comparing the morphological consistency of ventricular depolarizations and percentage effective LV pacing in CRT patients randomized to aCRT vs. echo-optimization. METHODS AND RESULTS: Continuous recordings (≥20 h) of unipolar LV electrograms from aCRT (n = 38) and echo-optimized patients (n = 22) were analysed. Morphological consistency was determined by the correlation coefficient between each beat and a template beat. Effective LV pacing of paced beats was assessed by algorithmic analysis of negative initial EGM deflection in each evoked response. The %CRT pacing delivered, %effective LV pacing (i.e. % of paced beats with effective LV pacing), and overall %effective CRT (i.e. product of %CRT pacing and %effective LV pacing) were compared between aCRT and echo-optimized patients. Demographics were similar between groups. The mean correlation coefficient between individual beats and template was greater for aCRT (0.96 ± 0.03 vs. 0.91 ± 0.13, P = 0.07). Although %CRT pacing was similar for aCRT and echo-optimized (median 97.4 vs. 98.6%, P = 0.14), %effective LV pacing was larger for aCRT [99.6%, (99.1%, 99.9%) vs. 94.3%, (24.3%, 99.8%), P=0.03]. For aCRT vs. echo-optimized groups, the proportions of patients with ≥90% effective LV pacing was 92 vs. 55% (P = 0.002), and with ≥90% effective CRT was 79 vs. 45%, respectively (P = 0.018). CONCLUSION: AdaptivCRT™ significantly increased effective LV pacing over echo-optimized CRT.

Automated detection of effective left-ventricular pacing: going beyond percentage pacing counters.

AIMS: Cardiac resynchronization therapy (CRT) devices report percentage pacing as a diagnostic but cannot determine the effectiveness of each paced beat in capturing left-ventricular (LV) myocardium. Reasons for ineffective LV pacing include improper timing (i.e. pseudofusion) or inadequate pacing output. Device-based determination of effective LV pacing may facilitate optimization of CRT response. METHODS AND RESULTS: Effective capture at the LV cathode results in a negative deflection (QS or QS-r morphology) on a unipolar electrogram (EGM). Morphological features of LV cathode-RV coil EGMs were analysed to develop a device-based automatic algorithm, which classified each paced beat as effective or ineffective LV pacing. The algorithm was validated using acute data from 28 CRT-defibrillator patients. Effective LV pacing and pseudofusion was simulated by pacing at various AV delays. Loss of LV capture was simulated by RV-only pacing. The algorithm always classified LV or biventricular (BV) pacing with AV delays ≤60% of patient's intrinsic AV delay as effective pacing. As AV delays increased, the percentage of beats classified as effective LV pacing decreased. Algorithm results were compared against a classification truth based on correlation coefficients between paced QRS complexes and intrinsic rhythm QRS templates from three surface ECG leads. An average correlation >0.9 defined a classification truth of ineffective pacing. Compared against the classification truth, the algorithm correctly classified 98.2% (3240/3300) effective LV pacing beats, 75.8% (561/740) of pseudofusion beats, and 100% (540/540) of beats with loss of LV capture. CONCLUSION: A device-based algorithm for beat-by-beat monitoring of effective LV pacing is feasible.

Tachycardia detection performance of implantable loop recorders: results from a large 'real-life' patient cohort and patients with induced ventricular arrhythmias.

AIMS: Implantable loop recorders (ILRs) are valuable for diagnosing arrhythmias. We evaluated tachycardia detection performance of the Medtronic Reveal(®) ILR with FullView™ Software. METHODS AND RESULTS: The rate of occurrence of tachycardia detection [supraventricular tachycardia, ventricular tachycardia (VT), and ventricular fibrillation (VF)] and the percentage of appropriately detected tachycardias were determined from all 2190 ILR patients that transmitted to CareLink over a 4-month period (total follow-up = 135.6 patient-years). All 1909 tachycardia episodes were reviewed. Episodes with actual heart rate above the programmed tachycardia detection rate were classified as appropriate. Sensitivity to detect true ventricular arrhythmias was assessed in another group of 215 patients undergoing implantable cardioverter defibrillator (ICD) implant testing. Skin electrodes represented ILR electrodes. Induced VF (404 episodes) and VT (93 episodes) were processed by an emulation of FullView Software. Generalized estimation equation analysis adjusted for multiple episodes per patient. In the CareLink cohort, 68.7% (63.9% adjusted) of detected episodes had tachycardia above the detection rate. Of 1642 episodes detected in the VT zone (12.1 episodes/patient-year), 78.8% (79.0% adjusted) had tachycardia above the detection rate. Of 267 episodes detected in the fast VT zone (1.9 episodes/patient-year), 6.7% (9.4% adjusted) had tachycardia above the detection rate. Twelve true VT/VF episodes were observed in 10 patients. In the ICD patient cohort, 95.9% (96.5% adjusted) of induced VT/VF segments were correctly detected at nominal rate cutoffs. When VT detection was set to 130 b.p.m. (to include the slowest VT), 99.0% (99.3% adjusted) were correctly detected. CONCLUSION: The majority (63.9%) of detected tachycardias contained true tachycardia. Sensitivity to detect induced VT/VF was 99.3%.

Reasons for loss of cardiac resynchronization therapy pacing: insights from 32 844 patients.

BACKGROUND: The efficacy of cardiac resynchronization therapy (CRT) is associated with the amount of CRT pacing delivered. The specific causes of CRT pacing loss and their relative frequencies remain poorly defined. METHODS AND RESULTS: CRT patients who transmitted device data from 2006 to 2011 were screened for inclusion. Device diagnostics were analyzed using an automated algorithm to categorize CRT loss into 10 different causes. The algorithm was validated against manual adjudications using a portion of the entire cohort. There were 80 768 patients analyzed with a median time of 594 (interquartile range, 294-1003) days from implant to time of analysis. In this cohort, 40.7% of patients had <98% pacing, and 11.5% of patients had <90% pacing. For patients with <98% pacing, device diagnostics explained 55.8% of pacing loss: 30.6% atrial tachycardia/atrial fibrillation; 16.6% premature ventricular contractions; and 8.6% captured as episodes with at least 10 consecutive beats of CRT loss (ventricular sensing episodes). Inappropriately programmed sensed and paced atrioventricular (AV) intervals (SAV/PAV) accounted for 34.5% of all ventricular sensing episodes. As the severity of CRT loss increased, the contribution of atrial tachycardia/atrial fibrillation and SAV/PAV to the loss increased. Atrial tachycardia/atrial fibrillation accounted for >50% and premature ventricular contractions accounted for <10% of CRT loss in those with <90% CRT pacing. CONCLUSIONS: CRT pacing <98% was observed in 40.7% of patients. Among those with suboptimal pacing, atrial tachycardia/atrial fibrillation was the most common reason for CRT pacing loss. Inappropriately programmed SAV/PAV intervals was the most common reason for episodes of sustained loss of CRT pacing. This information can help in defining more effective treatments to improve CRT delivery.

Downloadable algorithm to reduce inappropriate shocks caused by fractures of implantable cardioverter-defibrillator leads.

BACKGROUND: The primary method for monitoring implantable cardioverter-defibrillator lead integrity is periodic measurement of impedance. Sprint Fidelis leads are prone to pace-sense lead fractures, which commonly present as inappropriate shocks caused by oversensing. METHODS AND RESULTS: We developed and tested an algorithm to enhance early identification of lead fractures and to reduce inappropriate shocks. This lead-integrity algorithm, which can be downloaded into presently implanted implantable cardioverter-defibrillators, alerts the patient and/or physician when triggered by either oversensing or excessive increases in impedance. To reduce inappropriate shocks, the lead-integrity algorithm increases the number of intervals to detect (NID) ventricular fibrillation when triggered. The lead-integrity algorithm was tested on data from 15 970 patients with Fidelis leads (including 121 with clinically diagnosed fractures) and 95 other fractured leads confirmed by analysis of returned product. The effect of the NID on inappropriate shocks was tested in 92 patients with 927 shocks caused by lead fracture. Increasing the NID reduced inappropriate shocks (P<0.0001). The lead-integrity algorithm provided at least a 3-day warning of inappropriate shocks in 76% (95% CI, 66 to 84) of patients versus 55% (95% CI, 43 to 64) for optimal impedance monitoring (P=0.007). Its positive predictive value was 72% for lead fractures and 81% for lead fractures or header-connector problems requiring surgical intervention. The false-positive rate was 1 per 372 patient-years of monitoring. CONCLUSIONS: A lead-integrity algorithm developed for download into existing implantable cardioverter-defibrillators increases short-term warning of inappropriate shocks in patients with lead fractures and reduces the likelihood of inappropriate shocks. It is the first downloadable RAMware to enhance the performance of nominally functioning implantable cardioverter-defibrillators and the first implantable cardioverter-defibrillator monitoring feature that triggers real-time changes in ventricular fibrillation detection parameters to reduce inappropriate shocks.

Improved arrhythmia detection in implantable loop recorders.

INTRODUCTION: Implantable loop recorders (ILR) have an automatic arrhythmia detection feature that can be compromised by inappropriately detected episodes. This study evaluated a new ILR sensing and detection scheme for automatically detecting asystole, bradyarrhythmia, and tachyarrhythmia events, which is implemented in the next generation device (Reveal DX/XT). METHODS AND RESULTS: The new scheme employs an automatically adjusting R-wave sensing threshold, enhanced noise rejection, and algorithms to detect asystole, bradyarrhythmia, and tachyarrhythmia. Performance of the new algorithms was evaluated using 2,613 previously recorded, automatically detected Reveal Plus episodes from 533 patients. A total of 71.9% of episodes were inappropriately detected by the original ILR, and at least 88.6% of patients had one or more inappropriate episodes, with most inappropriate detections due to R-wave amplitude reductions, amplifier saturation, and T-wave oversensing. With the new scheme, inappropriate detections were reduced by 85.2% (P < 0.001), with a small reduction in the detection of appropriate episodes (1.7%, P < 0.001). The new scheme avoided inappropriate detections in 67.4% of patients that had them with the original scheme. CONCLUSIONS: The new sensing and detection scheme is expected to substantially reduce the occurrence of inappropriately detected episodes, relative to that of the original ILR.

Intrathoracic impedance to monitor heart failure status: a comparison of two methods in a chronic heart failure dog model.

In patients with heart failure (HF), a convenient and accurate assessment of HF status could enhance titration of medications and possibly reduce hospitalizations for fluid overload. This study examined the feasibility of monitoring HF status by measuring intrathoracic impedance with either an implantable cardioverter-defibrillator or a pacemaker. Six canines were each instrumented with four devices: two capable of measuring intrathoracic impedance between a right ventricular coil electrode and the device case, one custom pacemaker for inducing HF, and an implantable hemodynamic monitor to measure left ventricular end-diastolic pressure as an assessment of HF status. High-rate ventricular pacing for 3-7 weeks induced HF, followed by a 4-week recovery period. During high-rate pacing, left ventricular end-diastolic pressure was inversely correlated with impedance measurements from both systems (median r=-0.66; range r=-0.38 to -0.81). During recovery, the inverse correlation between left ventricular end-diastolic pressure and impedance was enhanced (median r=-0.88; range r=-0.58 to -0.95). The two types of impedance measurements were highly correlated (median r=-0.68 during pacing and r=-0.91 during recovery). These results suggest that various methods of measurement of intrathoracic impedance over time could be used to monitor HF status.

Intrathoracic impedance monitoring in patients with heart failure: correlation with fluid status and feasibility of early warning preceding hospitalization.

BACKGROUND: Patients with heart failure are frequently hospitalized for fluid overload. A reliable method for chronic monitoring of fluid status is therefore desirable. We evaluated an implantable system capable of measuring intrathoracic impedance to identify potential fluid overload before heart failure hospitalization and to determine the correlation between intrathoracic impedance and standard measures of fluid status during hospitalization. METHODS AND RESULTS: Thirty-three patients with NYHA class III and IV heart failure were implanted with a special pacemaker in the left pectoral region and a defibrillation lead in the right ventricle. Intrathoracic impedance was regularly measured and recorded between the lead and the pacemaker case. During hospitalizations, pulmonary capillary wedge pressure and fluid status were monitored. Ten patients were hospitalized for fluid overload 25 times over 20.7+/-8.4 months. Intrathoracic impedance decreased before each admission by an average of 12.3+/-5.3% (P<0.001) over an average of 18.3+/-10.1 days. Impedance reduction began 15.3+/-10.6 days (P<0.001) before the onset of worsening symptoms. There was an inverse correlation between intrathoracic impedance and pulmonary capillary wedge pressure (r=-0.61, P<0.001) and between intrathoracic impedance and net fluid loss (r=-0.70, P<0.001) during hospitalization. Automated detection of impedance decreases was 76.9% sensitive in detecting hospitalization for fluid overload, with 1.5 false-positive (threshold crossing without hospitalization) detections per patient-year of follow-up. CONCLUSIONS: Intrathoracic impedance is inversely correlated with pulmonary capillary wedge pressure and fluid balance and decreased before the onset of patient symptoms and before hospital admission for fluid overload. Regular monitoring of impedance may provide early warning of impending decompensation and diagnostic information for titration of medication.

Continuous autonomic assessment in patients with symptomatic heart failure: prognostic value of heart rate variability measured by an implanted cardiac resynchronization device.

BACKGROUND: Heart rate variability (HRV) as an indirect autonomic assessment provides prognostic information when measured over short time periods in patients with heart failure. Long-term continuous HRV can be measured from an implantable device, but the clinical value of these measurements is unknown. METHODS AND RESULTS: A total of 397 patients with New York Heart Association class III or IV heart failure were studied. Of these, 370 patients had information from their implanted cardiac resynchronization device for mortality risk stratification, and 288 patients had information for measured parameters (ie, HRV, night heart rate, and patient activity) and clinical event analyses. Continuous HRV was measured as the standard deviation of 5-minute median atrial-atrial intervals (SDAAM) sensed by the device. SDAAM <50 ms when averaged over 4 weeks was associated with increased mortality risk (hazard ratio 3.20, P=0.02) and SDAAM were persistently lower over the entire follow-up period in patients who required hospitalization or died. SDAAM decreased a median of 16 days before hospitalization and returned to baseline after treatment. Automated detection of decreases in SDAAM was 70% sensitive in detecting cardiovascular hospitalization, with 2.4 false-positives per patient-year of follow-up. CONCLUSIONS: This study demonstrates that SDAAM continuously measured from an implanted cardiac resynchronization device is lower in patients at high mortality and hospitalization risk. SDAAM declines as patient status decompensates. Continuous long-term SDAAM may be a useful tool in the clinical management of patients with chronic heart failure.

An adaptive interval-based algorithm for withholding ICD therapy during sinus tachycardia.

Avoiding inappropriate ICD therapy during supraventricular tachycardia (SVT) while assuring 100% sensitivity for VT/VF remains a challenge. Inappropriate VT/VF therapy during sinus tachycardia (ST) is particularly distressing to the patient because the full sequence of ICD therapies is often delivered. ST or 1:1 atrial tachycardia (AT) with long PR intervals and ST or AT with atrial oversensing of far-field R waves cause the majority of inappropriate therapy in the Medtronic GEM DR (Model 7271) ICD. The goals of the present effort were to define an adaptive interval-based algorithm for withholding VT/VF therapy in dual chamber ICDs during ST and to compare performance of the adaptive algorithm with that of the original ST withholding algorithm in the GEM DR. The adaptive algorithm uses a combination of 1:1 atrial to ventricular conduction pattern, changes in RR intervals and changes in intrinsic PR intervals to establish evidence for or against the presence of ST. Performances of the adaptive and original ST withholding algorithms were compared on 3 databases collected by implanted GEM DR devices. The first database included 684 spontaneous VT/VF episodes. The second database included 216 spontaneous SVT episodes that received inappropriate VT/VF therapy. These databases included up to 2,000 atrial or ventricular sensed or paced events preceding the spontaneous tachycardias. The third database included 320 spontaneous ST/AT episodes for which therapy was appropriately withheld by the GEM DR. Performance of the adaptive algorithm on the third database was predicted rather than directly computed because of record length limitations. VT/VF therapy was classified as "withheld" if evidence of ST remained high for one algorithm (i.e., at least 7 more beats to VT/VF detection) at the point of VT/VF detection by the other algorithm. For the 684 true VT/VF episodes, the original algorithm withheld VT/VF therapy in 5 episodes and the adaptive algorithm withheld VT/VF therapy in 3 episodes. The 95% confidence interval for the difference in VT/VF sensitivity between the adaptive and original algorithms was [-0.5 to + 1.1%]. Twelve of the 320 ST/AT episodes (3.8%) that were appropriately classified by the original algorithm were predicted to receive inappropriate therapy by the adaptive algorithm. However, relative to the original algorithm, the adaptive algorithm appropriately withheld VT/VF therapy for 76 of 216 true SVT episodes (i.e., incremental specificity of 35.2%). For the specific SVT episodes that were the targets for improvement by the adaptive ST algorithm (ST/AT with long PR intervals and ST/AT with intermittent atrial oversensing of far-field R waves), the adaptive algorithm reduced inappropriate therapy by 63.2%.

Comparison of electrocardiogram and intrathoracic electrogram signals for detection of ischemic ST segment changes during normal sinus and ventricular paced rhythms.

INTRODUCTION: The aim of this study was to compare surface ECGs with electrograms (EGM) that are available from implanted devices for the ability to detect ischemic ST segment changes during normal sinus (NS) and ventricular paced (VP) rhythms. METHODS AND RESULTS: ECG leads I, II, and V2, right atrial ring to left pectoral patch (representing the can of the device), right ventricular ring to left pectoral patch, and right atrial ring to right ventricular ring EGM were recorded continuously during percutaneous transluminal coronary angioplasty. One balloon inflation (> or = 60 sec) was analyzed from each of 22 NS and 22 VP subjects. The parameter AST was defined as the maximum absolute ST segment deviation (from isoelectric) during the first 60 seconds of inflation, measured relative to the baseline (preinflation) ST segment deviation. For EGM, a normalized deltaST was defined as the AST divided by the ratio of QRS amplitudes of EGM to ECG. During NS, the deltaST for EGM (0.43 mV) was significantly larger than that of ECG (0.09 mV, P = 0.0001) but the normalized deltaST for EGM (0.11 mV) was comparable to that of ECG (0.09 mV, P = 0.45). During VP, the AST for EGM (1.08 mV) was significantly larger than that of ECG (0.17 mV, P = 0.0001), but the normalized AST for EGM (0.11 mV) was significantly smaller than that of ECG (0.17 mV, P = 0.02). CONCLUSION: During both NS and VP, ischemic ST segment changes were significantly larger in EGM than in ECG. Much of this difference appears to be related to larger amplitudes of EGM signals. (J