Evaluation of a novel PVC and PAC detection algorithm in an implantable cardiac monitor for longitudinal risk monitoring.
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ABSTRACT:
SUBMITTER: Marmerstein J
PROVIDER: S-EPMC10513916 | biostudies-literature | 2023 Sep
REPOSITORIES: biostudies-literature
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Evaluation of a novel PVC and PAC detection algorithm in an implantable cardiac monitor for longitudinal risk monitoring.
Marmerstein Joseph J Reddy Ravi R Whittington R Hollis RH Dukes Jonathan J
Heart rhythm O2 20230827 9
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Project description:IntroductionWe conducted this study to show the safety and efficacy of a new implantable cardiac monitor (ICM), the BioMonitor 2 (Biotronik SE & Co. KG; Berlin, Germany), and to describe the arrhythmia detection performance.MethodsThe BioMonitor 2 has an extended sensing vector and is implanted close to the heart. It can transmit up to six subcutaneous electrocardiogram strips by Home Monitoring each day. We enrolled 92 patients with a standard device indication for an ICM in a single-arm, multicenter prospective trial. Patients were followed for 3 months, and 48-h Holter recordings were used to evaluate the arrhythmia detection performance.ResultsOne patient withdrew consent and in one patient, the implantation failed. Two study device-related serious adverse events were reported, satisfying the primary safety hypothesis. Implantations took 7.4 ± 4.4 min from skin cut to suture. At 1 week, the R-wave amplitude was 0.75 ± 0.53 mV. In the 82 patients with completed Holter recordings, all patients with arrhythmias were correctly identified. False positive detections of arrhythmia were mostly irregular rhythms wrongly detected as atrial fibrillation (episode-based positive predictive value 72.5%). Daily Home Monitoring transmission was 94.9% successful.ConclusionSafety and efficacy of the new device has been demonstrated. The detected R-wave amplitudes are large, leading to a low level of inappropriate detections due to over- or undersensing.
| S-EPMC6851891 | biostudies-literature
Project description:BackgroundImplantable cardiac monitors (ICMs) help investigate the cause of unexplained syncope, but the probability and predictors of needing a pacing device thereafter remain unclear.MethodsWe retrospectively analyzed the data of patients who received ICM insertion for unexplained syncope with suspected arrhythmic etiology. The data were obtained from a nationwide database obtained between April 1, 2012 and March 31, 2020. Multivariable mixed-effects survival analysis was performed to identify predictors of pacing device implantation (PDI), and a risk score model was developed accordingly.ResultsIn total, 2905 patients (age: 72 years [range: 60-78]) implanted with ICMs to investigate the cause of syncope were analyzed. During the median follow-up period of 128 days (range: 68-209) days, 473 patients (16%) underwent PDI. Older age, history of atrial fibrillation, bundle branch block (BBB), and diabetes were independent predictors of PDI in multivariable analysis. A risk score model was developed with scores ranging from 0 to 32 points. When patients with the lowest quartile score (0-13 points) were used as a reference, those with higher quartiles had a higher risk of PDI (second quartile: 14-15 points, hazard ratio [HR]: 3.86, 95% confidence interval [CI]: 2.62-5.68; third quartile: 16-18 points, HR: 4.67, 95% CI: 3.14-6.94; fourth quartile: 19-32 points, HR: 6.59, 95% CI: 4.47-9.71).ConclusionsThe 4 identified predictors are easily assessed during the initial evaluation of patients with syncope. They may help identify patients with a higher risk of requiring permanent PDI.
| S-EPMC10140738 | biostudies-literature
Project description:Cardiac monitoring after heart surgeries is crucial for health maintenance and detecting postoperative complications early. However, current methods like rigid implants have limitations, as they require performing second complex surgeries for removal, increasing infection and inflammation risks, thus prompting research for improved sensing monitoring technologies. Herein, we introduce a nanosensor platform that is biodegradable, biocompatible, and integrated with multifunctions, suitable for use as implants for cardiac monitoring. The device has two electrochemical biosensors for sensing lactic acid and pH as well as a pressure sensor and a chemiresistor array for detecting volatile organic compounds. Its biocompatibility with myocytes has been tested in vitro, and its biodegradability and sensing function have been proven with ex vivo experiments using a three-dimensional (3D)-printed heart model and 3D-printed cardiac tissue patches. Moreover, an artificial intelligence-based predictive model was designed to fuse sensor data for more precise health assessment, making it a suitable candidate for clinical use. This sensing platform promises impactful applications in the realm of cardiac patient care, laying the foundation for advanced life-saving developments.
| S-EPMC10825867 | biostudies-literature
Project description:AimsRemote monitoring for patients with cardiac implantable electronic devices (CIEDs) is well established in clinical routine and recommended by current guidelines. Nevertheless, data regarding patients' perceptions are limited. Therefore, this study aims to analyze the patient perspectives on the remote monitoring of cardiac devices in Germany.Methods and resultsPatients with CIEDs and remote monitoring of all current manufacturers from three German centers were asked to participate. The questionnaire consisted of 37 questions regarding the patients' individual use and perspectives on remote monitoring. Survey participation was anonymous and on a voluntary basis. A total of 617 patients (71.6% men) participated. Most patients reported feeling well informed (69.3%) and reported having unchanged or improved coping (98.8%) since the start of remote monitoring. At least 39.7% of patients experienced technical problems regarding the transmitter, whereas most patients (60.3%) reported that they never noted technical issues. Older patients had significantly less interest than younger patients in using their own smartphones for data transfer (p < 0.001).ConclusionPatients with remote follow-up of CIED reported that they felt well informed about the remote monitoring approach. Remote monitoring can support coping with their disease. With remote monitoring, patients experienced a prolongation of intervals of in-person follow-up visits, and especially younger patients would appreciate smartphone-based data transfer of their CIEDs.
| S-EPMC10017432 | biostudies-literature
Project description:While several studies have compared the radiofrequency current (RFC) and cryoablation for the treatment of patients with atrial fibrillation (AF), no study has monitored the long-term outcomes with the usage of implantable loop recorders (ILRs).We enrolled 89 consecutive patients with nonvalvular paroxysmal AF (N = 44 for RFC and N = 45 for cryoballoon). The primary efficacy end point was the assessment of effectiveness for each group (RFC versus cryoballoon) when examining freedom from arrhythmia by monitoring with ECG, Holter, and implantable loop recoder (ILR). The primary safety end point compared rates of adverse events between both groups. The secondary efficacy end point examined the duration of the postablation blanking period from ILR retrieved data.The mean age of the study population was 56.6 ± 10.2 years, and the follow-up duration was 12 months. There were no differences in baseline patient characteristics between groups. At 12 months, the absolute effectiveness (measured by ILR) was 65.9% in the RFC group and 51.1% in the cryoballoon group (OR = 1.85; 95% CI: 0.79-4.35; p = 0.157), and the clinical effectiveness (measured by ECG and Holter) was 81.8% in the RFC group and 55.6% in the cryoballoon group (OR = 3.6; 95% CI: 1.37-9.46; p = 0.008). There was no difference in safety between both groups. Asymptomatic episodes were significantly more present in the RFC group as measured by ILRs (p < 0.010). In cryoballoon group, arrhythmia episodes were recorded equally irrespective of the follow-up method (i.e., ECG and Holter versus ILR (p > 0.010)). The blanking period does not seem to be as important in cryoballoon as compared to RFC.RFC and cryoballoon ablation had similar absolute effectiveness at 12 months. ECG and Holter were effective when assessing the efficacy of the cryoballoon ablation; however, in the RFC group, ILR was necessary to accurately assess long-term efficacy.
| S-EPMC5867681 | biostudies-literature
Project description:Measurement of changes in brain cortical thickness is useful for the assessment of regional gray matter atrophy in neurodegenerative conditions. A new longitudinal method, called CLADA (cortical longitudinal atrophy detection algorithm), has been developed for the measurement of changes in cortical thickness in magnetic resonance images (MRI) acquired over time. CLADA creates a subject-specific cortical model which is longitudinally deformed to match images from individual time points. The algorithm was designed to work reliably for lower resolution images, such as the MRIs with 1×1×5 mm(3) voxels previously acquired for many clinical trials in multiple sclerosis (MS). CLADA was evaluated to determine reproducibility, accuracy, and sensitivity. Scan-rescan variability was 0.45% for images with 1mm(3) isotropic voxels and 0.77% for images with 1×1×5 mm(3) voxels. The mean absolute accuracy error was 0.43 mm, as determined by comparison of CLADA measurements to cortical thickness measured directly in post-mortem tissue. CLADA's sensitivity for correctly detecting at least 0.1mm change was 86% in a simulation study. A comparison to FreeSurfer showed good agreement (Pearson correlation=0.73 for global mean thickness). CLADA was also applied to MRIs acquired over 18 months in secondary progressive MS patients who were imaged at two different resolutions. Cortical thinning was detected in this group in both the lower and higher resolution images. CLADA detected a higher rate of cortical thinning in MS patients compared to healthy controls over 2 years. These results show that CLADA can be used for reliable measurement of cortical atrophy in longitudinal studies, even in lower resolution images.
| S-EPMC2965022 | biostudies-literature
Project description:ObjectiveWith the recent development of various MRI-conditional cardiac implantable electronic devices (CIEDs), the accurate identification and characterization of CIEDs have become critical when performing MRI in patients with CIEDs. We aimed to develop and evaluate a deep learning-based algorithm (DLA) that performs the detection and characterization of parameters, including MRI safety, of CIEDs on chest radiograph (CR) in a single step and compare its performance with other related algorithms that were recently developed.Materials and methodsWe developed a DLA (X-ray CIED identification [XCID]) using 9912 CRs of 958 patients with 968 CIEDs comprising 26 model groups from 4 manufacturers obtained between 2014 and 2019 from one hospital. The performance of XCID was tested with an external dataset consisting of 2122 CRs obtained from a different hospital and compared with the performance of two other related algorithms recently reported, including PacemakerID (PID) and Pacemaker identification with neural networks (PPMnn).ResultsThe overall accuracies of XCID for the manufacturer classification, model group identification, and MRI safety characterization using the internal test dataset were 99.7% (992/995), 97.2% (967/995), and 98.9% (984/995), respectively. These were 95.8% (2033/2122), 85.4% (1813/2122), and 92.2% (1956/2122), respectively, with the external test dataset. In the comparative study, the accuracy for the manufacturer classification was 95.0% (152/160) for XCID and 91.3% for PPMnn (146/160), which was significantly higher than that for PID (80.0%,128/160; p < 0.001 for both). XCID demonstrated a higher accuracy (88.1%; 141/160) than PPMnn (80.0%; 128/160) in identifying model groups (p < 0.001).ConclusionThe remarkable and consistent performance of XCID suggests its applicability for detection, manufacturer and model identification, as well as MRI safety characterization of CIED on CRs. Further studies are warranted to guarantee the safe use of XCID in clinical practice.
| S-EPMC8546129 | biostudies-literature
Project description:BackgroundTranscatheter aortic valve implantation (TAVI) is associated with new onset brady- and tachyarrhythmias which may impact clinical outcome.AimsTo investigate the true incidence of new onset arrhythmias within 12 months after TAVI using an implantable cardiac monitor (ICM).MethodsOne hundred patients undergoing TAVI received an ICM within 3 months before or up to 5 days after TAVI. Patients were followed-up for 12 months after discharge from TAVI for the occurrence of atrial fibrillation (AF), bradycardia (≤30 bpm), advanced atrioventricular (AV) block, sustained ventricular and supraventricular tachycardia.ResultsA previously undiagnosed arrhythmia was observed in 31 patients (31%) and comprised AF in 19 patients (19%), advanced AV block in 3 patients (3%), and sustained supraventricular and ventricular tachycardia in 10 (10%) and 2 patients (2%), respectively. Three patients had a clinical diagnosis of sick-sinus-syndrome. A permanent pacemaker (PPM) was implanted in six patients (6%). The prevalence of pre-existing AF was 28%, and 47% of the patients had AF at the end of the study period. AF burden was significantly higher in patients with pre-existing [26.7% (IQR 0.3%; 100%)] compared to patients with new-onset AF [0.0% (IQR 0.0%; 0.06%); p = 0.001]. Three patients died after TAVI without evidence of an arrhythmic cause according to the available ICM recordings.ConclusionsRhythm monitoring for 12 months after TAVI revealed new arrhythmias, mainly AF, in almost one third of patients. Atrial fibrillation burden was higher in patients with prevalent compared to incident AF. Selected patients may benefit from short-term remote monitoring.Trial registrationhttps://clinicaltrials.gov/: NCT02559011.
| S-EPMC9149277 | biostudies-literature
Project description:BackgroundSince the CRYSTAL-AF trial, implantation and usage of implantable loop recorder (ICM) after cryptogenic stroke (CS) for detection of atrial fibrillation (AF) has increased. However, it is unclear which CS patients would most benefit from long term ICM monitoring. This study aims to determine the risk factors in patients that would confer maximum benefit from ICM placement following CS.MethodsA Columbia University Institutional Review Board (IRB) approved retrospective analysis of medical records of 125 patients with CS followed by implantation of ICM was evaluated. Univariable and multivariable time-to-event analyses were performed on demographics, hours of activity and variability (HRV), stroke location, thrombosis etiology, and CHA2DS2 - VASc score. The primary outcome was presence of ICM-detected AF defined as AF lasting at least 2 min.ResultsOne hundred twenty-five patients (mean 67.6 years ± 2.4 years, 60% male) were followed for at least 3 months. Twenty-two patients (18%) were found to have clinically verified detected AF; median of time to detection was 95 days. Upon univariable demographic analysis followed by multivariable Cox regression analysis, individuals with age 75 or older (HR: 3.987, p = 0.0046) or LVEF 40% and lower (HR: 3.056, p = 0.0213) had significantly higher risk of AF. Diabetics also had a lower AF detection in multivariable analysis (HR: 0.128, p = 0.0466).ConclusionsAge 75 or older and LVEF ≤40% were the factors on multivariable analysis that predicted AF detection. Diabetes is a possible significant factor which should be evaluated further. CHA2DS2 - VASc score was notably not predictive of AF detected on ICM.
| S-EPMC8016653 | biostudies-literature
Project description:Background and purposeCurrent guidelines do not provide firm directions on atrial fibrillation (AF) screening after ischemic stroke (IS). We sought to investigate the association of implantable cardiac monitoring (ICM) duration with the yield of AF detection in IS patients.MethodsWe included studies reporting AF detection rates by ICM in IS patients with negative initial AF screening. We excluded studies reporting prolonged cardiac monitoring with devices other than ICM, not providing AF detection rates or monitoring duration, and reporting overlapping data for the same population. The random-effects model was used for all pooled estimates and meta-regression analyses.ResultsWe included 28 studies (4,531 patients, mean age 65 years). In meta-regression analyses, the proportion of AF detection by ICM was independently associated with monitoring duration (coefficient=0.015; 95% confidence interval [CI], 0.005 to 0.024) and mean patient age (coefficient=0.009; 95% CI, 0.003 to 0.015). No associations were detected with other patient characteristics, including IS subtype (cryptogenic vs. embolic stroke of undetermined source) or time from IS onset to CM implantation. In subgroup analyses, significant differences (P<0.001) in the AF detection rates were found for ICM duration (<6 months: 5% [95% CI, 3% to 6%]; ≥6 and ≤12 months: 21% [95% CI, 16% to 25%]; >12 and ≤24 months: 26% [95% CI, 22% to 31%]; >24 months: 34% [95% CI, 29% to 39%]).Conclusions Extended duration of ICM monitoring and increased patient age are factors that substantially increase AF detection in IS patients with initial negative AF screening.
| S-EPMC6780018 | biostudies-literature