Dataset Information

Regional variations in baseline characteristics of cardiac rhythm device recipients: The PANORAMA observational cohort study.

ABSTRACT: Background:The PANORAMA study was designed to collect concurrent data on subjects from different worldwide regions implanted with CRM devices. Methods:In this prospective, multi-center study, we analyzed baseline data on 8586 subjects implanted with CRM devices with no additional selection criteria (66% pacemaker (IPG), 16% implantable cardiac defibrillators (ICD), 17% cardiac resynchronization therapy (CRT) and < 1% Internal Loop Recorder) from 156 hospitals across 6 geographical regions between 2005 and 2011. Results:Regardless of the device implanted, subjects from the Middle East and India often had more diabetes than other regions. Eastern and Western Europe had higher rates of atrial fibrillation reported, and men were more likely to smoke than women (46% vs 11%, p < 0.001). Within the CRT cohort there was significant variation in the proportion of males receiving a device, ranging from 55% in India to 83% in Eastern Europe. Conclusions:We provide comprehensive descriptive data on patients receiving CRM devices from a range of geographies that are not typically reported in literature. We found significant variations in clinical characteristics and implant practices. Long term follow-up data will help evaluate if these variations require adjustments to outcome expectations.

SUBMITTER: Al Kandari F

PROVIDER: S-EPMC5801449 | biostudies-literature | 2014 Sep

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Regional variations in baseline characteristics of cardiac rhythm device recipients: The PANORAMA observational cohort study.

Al Kandari Fawziah F Erglis Andrejs A Sweidan Raed R Dannheimer Ingrid I Sepsi Milan M Bénézet Juan J Padour Michal M Naik Ajay A Escudero Jaime J West Teena T Holbrook Reece R Lorgat Faizel F

International journal of cardiology. Heart & vessels 20140706

<h4>Background</h4>The PANORAMA study was designed to collect concurrent data on subjects from different worldwide regions implanted with CRM devices.<h4>Methods</h4>In this prospective, multi-center study, we analyzed baseline data on 8586 subjects implanted with CRM devices with no additional selection criteria (66% pacemaker (IPG), 16% implantable cardiac defibrillators (ICD), 17% cardiac resynchronization therapy (CRT) and < 1% Internal Loop Recorder) from 156 hospitals across 6 geographical ...[more]

PMID: 29450186

Similar Datasets

Project description:BackgroundSacubitril/valsartan has been approved for the management of heart failure (HF) with reduced ejection fraction in adults. PANORAMA-HF trial (Prospective Trial to Assess the Angiotensin Receptor Blocker Neprilysin Inhibitor LCZ696 Versus Angiotensin-Converting Enzyme Inhibitor for the Medical Treatment of Pediatric HF) investigated its effects on clinical outcomes in pediatric patients with HF.MethodsPANORAMA-HF is a multicenter, Phase II/III study using an adaptive, seamless, 2-part design. The study aimed to evaluate the pharmacokinetics and pharmacodynamics of single doses of sacubitril/valsartan (Part 1), and the efficacy and safety of sacubitril/valsartan versus enalapril administered twice daily for 52 weeks (Part 2) in pediatric patients with HF due to left ventricular systolic dysfunction with biventricular heart physiology. An innovative trial design using a novel global rank assessment of severity was employed. For analysis, eligible patients were stratified into 3 age groups (Group 1, 6 to <18 years; Group 2a, 2 to <6 years; and Group 3a, 1 month to <2 years) and functional classification (New York Heart Association/Ross class I/II and III/IV).ResultsWe report the key demographic, baseline, and clinical characteristics of 375 pediatric patients randomized to receive the study medication. The mean age for patients in Groups 1, 2a, and 3a was 12.2, 3.2, and 1.3 years, respectively. About 70% of patients had a prior HF hospitalization, 85% had New York Heart Association/Ross class I/II HF, and ≈8% were angiotensin-converting enzyme inhibitor/angiotensin receptor blocker naïve.ConclusionsCompared to other pediatric HF studies, PANORAMA-HF recruited a relatively homogeneous pediatric HF population across 3 age groups, enabling a more robust evaluation of pharmacokinetics/pharmacodynamics and efficacy/safety of sacubitril/valsartan. Most patients had mildly symptomatic HF at baseline.RegistrationURL: https://www.Clinicaltrialsgov; Unique identifier: NCT02678312.

Project description:BackgroundAtrial fibrillation (AF) is the most common arrhythmia after cardiac surgery, yet the precise incidence and significance of arrhythmias after discharge home need to be better defined. Photoplethysmography (PPG)-based smartphone apps are promising tools to enable early detection and follow-up of arrhythmias.ObjectiveBy using a PPG-based smartphone app, we aimed to gain more insight into the prevalence of AF and other rhythm-related complications upon discharge home after cardiac surgery and evaluate the implementation of this app into routine clinical care.MethodsIn this prospective, single-center trial, patients recovering from cardiac surgery were asked to register their heart rhythm 3 times daily using a Food and Drug Administration-approved PPG-based app, for either 30 or 60 days after discharge home. Patients with permanent AF or a permanent pacemaker were excluded.ResultsWe included 24 patients (mean age 60.2 years, SD 12 years; 15/23, 65% male) who underwent coronary artery bypass grafting and/or valve surgery. During hospitalization, 39% (9/23) experienced postoperative AF. After discharge, the PPG app reported AF or atrial flutter in 5 patients. While the app notified flutter in 1 patient, this was a false positive, as electrocardiogram revealed a 2nd-degree, 2:1 atrioventricular block necessitating a permanent pacemaker. AF was confirmed in 4 patients (4/23, 17%) and interestingly, was associated with an underlying postoperative complication in 2 participants (pneumonia n=1, pericardial tamponade n=1). A significant increase in the proportion of measurements indicating sinus rhythm was observed when comparing the first to the second month of follow-up (P<.001). In the second month of follow-up, compliance was significantly lower with 2.2 (SD 0.7) measurements per day versus 3.0 (SD 0.8) measurements per day in the first month (P=.002). The majority of participants (17/23, 74%), as well as the surveyed primary care physicians, experienced positive value by using the app as they felt more involved in the postoperative rehabilitation.ConclusionsImplementation of smartphone-based PPG technology enables detection of AF and other rhythm-related complications after cardiac surgery. An association between AF detection and an underlying complication was found in 2 patients. Therefore, smartphone-based PPG technology may supplement rehabilitation after cardiac surgery by acting as a sentinel for underlying complications, rhythm-related or otherwise.

Project description:We examine how convolutional neural networks (CNNs) for cardiac rhythm device detection can exhibit failures in performance under suboptimal deployment scenarios and examine how medically adversarial image presentation can further impair neural network performance. We validated the publicly available Pacemaker-ID web server and mobile app on 43 local hospital emergency department (ED) cases of patients presenting with a cardiac rhythm device on anterior-posterior (AP) chest radiograph and assessed performance using Cohen's kappa coefficient for inter-rater reliability. To illustrate adversarial performance concerns, we then produced example CNN models using the 65,379 patient MIMIC-CXR chest radiograph retrospective database and evaluated performance with area under the receiver operating characteristic (AUROC). In retrospective review of 43 patients with cardiac rhythm devices on AP chest radiographs during our study period (January 1, 2020 to March 1, 2020), 74.4% (32/43) had device manufacturer information readily available within the electronic medical record. A total of 25.6% of patients (11/43) did not have this information documented in the patient chart and could ostensibly benefit from CNN-based identification of device manufacturer. For patients with known device manufacturer, the Pacemaker-ID prediction was accurate in 87.5% of cases (28/32). Mobile app accuracy varied from 62.5 to 93.75% depending on image capture settings and presentation. Cohen's kappa coefficient varied from 0.448 to 0.897 depending on mobile image capture conditions. For our additional analysis of medically adversarial performance failures with a DenseNet121 trained on MIMIC-CXR images, we showed that an AUROC of 0.9807 ± 0.0051 could be achieved on an example testing dataset while masking a 30% false positive rate in identification of cardiac rhythm devices versus clinically distinct entities such as vagal nerve stimulators. Despite the promise of CNN approaches for cardiac rhythm device analysis on chest radiographs, further study is warranted to assess potential for errors driven by user misuse when deploying these models to mobile devices as well as for cases when performance can be impaired by the presence of other support apparatuses.

Dataset Information

Regional variations in baseline characteristics of cardiac rhythm device recipients: The PANORAMA observational cohort study.

Publications

Regional variations in baseline characteristics of cardiac rhythm device recipients: The PANORAMA observational cohort study.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets