Forensic, legal, and clinical aspects of deaths associated with implanted cardiac devices
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SUBMITTER: Federspiel J
PROVIDER: S-EPMC10713765 | biostudies-literature | 2023 Jan
REPOSITORIES: biostudies-literature
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Project description:BACKGROUND:Physical activity is predictive of cardiovascular outcomes in patients with cardiovascular implantable electronic devices, yet it is not regularly assessed in routine care. Current-generation cardiovascular implantable electronic devices, however, continuously monitor patient activity through a built-in accelerometer, which provides new opportunities to remotely assess patient activity, detect changes in clinical status, and incorporate these data in risk stratification models. This review critically examines the literature on device-measured physical activity (D-PA), with a focus on identifying methodological issues that may affect interpretation of study results. METHODS AND RESULTS:We conducted a systematic review of D-PA studies published from January 1 1995 to December 30 2017, identifying 29 studies meeting inclusion criteria, 5 of which were validation reports. Few technical details about D-PA sensors are reported, and procedures for analyzing and interpreting D-PA data are heterogeneous. Trends in D-PA over time and associations with clinical outcomes were reported by 22 studies, and in 7 studies, D-PA was combined with other device parameters in risk stratification models, demonstrating modest-to-good sensitivity in predicting acute heart failure decompensation, hospitalization, and mortality. CONCLUSIONS:Current evidence suggests that D-PA may be useful for assessing physical activity and predicting clinical outcomes in patients with cardiovascular implantable electronic devices when combined with other device parameters. Future work must address challenges related to D-PA data measurement, interpretation, and generalizability to support expanded clinical applications of this technology.
| S-EPMC6015387 | biostudies-literature
Project description: Not available
| S-EPMC9615444 | biostudies-literature
Project description:BackgroundMagnetic resonance imaging (MRI) has been performed safely in patients without MRI-conditional cardiac implantable electronic devices (CIEDs), but experience specifically with cardiac magnetic resonance imaging (CMR) is limited in this patient population.ObjectiveEvaluate the safety of CMR in non-MRI-conditional CIEDs and the interpretability of images using wideband sequences.MethodsWe performed 114 consecutive CMR studies in 111 patients (mean age 59 ± 14 years, with 12 pacemakers, 73 implantable cardioverter defibrillators, 29 biventricular defibrillators) using a wideband pulse sequence for late gadolinium enhancement (LGE) imaging. A standardized protocol for device management and patient monitoring was followed. Patients were evaluated for major clinical adverse events and device parameter changes immediately after CMR and at clinical follow-up.ResultsIn total, 111 CMR studies were completed successfully. There were no patient deaths, new arrhythmias, immediate generator or lead failures, electrical resets, or pacing capture failures in dependent patients. Right atrial, right ventricular, and left ventricular lead impedances were significantly lower post CMR, with median differences -7 Ω (interquartile range [IQR] -20 to 0 Ω; P < .0001), 0 Ω (IQR -19 to 0 Ω; P = .0001), and -10 Ω (IQR -30 to 0 Ω; P = .023), respectively. These changes persisted through the follow-up period, with median differences -18.5 Ω (IQR -41 to -66 Ω; P = .007), -19 Ω (IQR -44 to -7 Ω; P = .006), and -30 Ω (IQR -130 to 0 Ω; P = .003), respectively. Ninety-seven studies (87%) had no artifact limiting interpretation.ConclusionsCMR can be performed safely in non-MRI-conditional CIEDs using a standardized protocol. Use of a wideband pulse sequence for LGE imaging yields a high rate of studies unaffected by artifact.
| S-EPMC5823604 | biostudies-literature
Project description:PurposeTo propose and test a modified wideband late gadolinium enhancement (LGE) magnetic resonance (MR) imaging technique to overcome hyperintensity image artifacts caused by implanted cardiac devices.Materials and methodsWritten informed consent was obtained from all participants, and the HIPAA-compliant study protocol was approved by the institutional review board. Studies in phantoms and in a healthy volunteer were performed to test the hypothesis that the hyperintensity artifacts that are typically observed on LGE images in patients with implanted cardiac devices are caused by insufficient inversion of the affected myocardial signal. The conventional LGE MR imaging pulse sequence was modified by replacing the nonselective inversion pulse with a wideband inversion pulse. The modified LGE sequence, along with the conventional LGE sequence, was evaluated in 12 patients with implantable cardioverter defibrillators (ICDs) who were referred for cardiac MR imaging.ResultsThe ICD causes 2-6 kHz in frequency shift at locations 5-10 cm away from the device. This off-resonance falls outside the typical spectral bandwidth of the nonselective inversion pulse used in conventional LGE, which results in the hyperintensity artifact. In 10 of the 12 patients, the conventional LGE technique produced severe, uninterpretable hyperintensity artifacts in the anterior and lateral portions of the left ventricular wall. These artifacts were eliminated with use of the wideband LGE sequence, thereby enabling confident evaluation of myocardial viability.ConclusionThe modified wideband LGE MR imaging technique eliminates the hyperintensity artifacts seen in patients with cardiac devices. The technique may enable LGE MR imaging in patients with cardiac devices, in whom LGE MR imaging otherwise could not be used for diagnosis.
| S-EPMC4228714 | biostudies-literature
Project description:Mass spectrometry has made profound contributions to the criminal justice system by providing an instrumental method of analysis that delivers exquisite analytical figures of merit for a wide variety of samples and analytes. Applications include the characterization of trace metal impurities in hair and glass to the identification of drugs, explosives, polymers, and ignitable liquids. This review describes major historical developments and, where possible, relates the developed capabilities to casework and legal precedents. This review also provides insight into how historical applications have evolved into, and out of, modern consensus standards. Unlike many pattern-based techniques and physical-matching methods, mass spectrometry has strong scientific foundations and a long history of successful applications that have made it one of the most reliable and respected sources of scientific evidence in criminal and civil cases. That said, in several appellate decisions in which mass spectrometric evidence was challenged but admitted, decisions sometimes still went against the mass spectrometric data anyway, which goes to show that mass spectrometric evidence is always just one piece of the larger legal puzzle.
| S-EPMC10326920 | biostudies-literature
Project description:Cardiac implantable electric devices are commonly used to treat heart failure. Little is known about temporal and geographic variation in use of cardiac resynchronization therapy (CRT) devices in usual care settings. We identified new CRT with pacemaker (CRT-P) or defibrillator generators (CRT-D) implanted between 2008 and 2013 in the United States from a commercial claims database. For each implant, we characterized prior medication use, comorbidities, and geography. Among 17 780 patients with CRT devices (median age 69, 31% women), CRT-Ps were a small and increasing share of CRT devices, growing from 12% to 20% in this study period. Compared to CRT-D recipients, CRT-P recipients were older (median age 76 versus 67), and more likely to be female (40% versus 30%). Pre-implant use of β-blockers and angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers was low in both CRT-D (46%) and CRT-P (31%) patients. The fraction of CRT-P devices among all new implants varied widely across states. Compared to the increasing national trend, the share of CRT-P implants was relatively increasing in Kansas and relatively decreasing in Minnesota and Oregon. In this large, contemporary heart failure population, CRT-D use dwarfed CRT-P, though the latter nearly doubled over 6 years. Practice patterns vary substantially across states and over time. Medical therapy appears suboptimal in real-world practice.
| S-EPMC5015279 | biostudies-literature
Project description:AimsForensic autopsies are important for the investigation of deaths with a legal or public-health interest, as well as being a source for cause-of-death statistics. The aim of this study was to investigate the use of forensic autopsies in Norway, with a special emphasis on geographical variation.MethodsData from the Norwegian Cause of Death Registry for the years 1996-2017 included 920,232 deaths and 37,398 forensic autopsies. We used logistic regression to identify factors that were associated with the proportion of forensic autopsies, grouped according to the registered cause of death. Explanatory variables were age and sex, place of death, police district, population size and urbanity level of the municipality and distance to the autopsy facility.ResultsThe proportion of deaths undergoing forensic autopsy was 4.1%, with the highest being homicides (96.6%) and the lowest being deaths from natural causes (1.7%). Variation between police districts was 0.9-7.8%, and the span persisted during the study period. The most important explanatory variables across the strata were place of death (there were few autopsies of deaths in health-care facilities), police district and age of the deceased. Distance to the autopsy facility, sex, population size and the level of urbanity had only a minor influence. The variation between police districts was not fully accounted for by the other investigated factors.Conclusions
| S-EPMC9152604 | biostudies-literature
Project description:BackgroundForensic patients are often admitted to psychiatric hospitals without any details of illness or treatment. They pose a unique challenge for clinical services in the context of diagnosis, management, and particularly legal issues.Materials and methodsWe conducted a retrospective chart review using a structured data-extraction tool. A total of 23 female forensic inpatients were admitted under the Department of Psychiatry from January 2006 to June 2016. Data were analyzed by descriptive statistics.ResultsThe mean age of the patients was 31.3 ± 7.9 years. In total, 82.6% of them were married, 87% were from a nuclear family, and 78.3% were from an urban background. Totally, 73.9% were referred from prison and 26.1% from the court. However, 73.9% were referred for the purpose of diagnosis and treatment and 21.7% for assessment of fitness to stand trial. Moreover, 47.8% had an alleged charge of murder (of killing close family members). A total of 30.4% had schizophrenia and other psychotic disorders, and 47.8% had a mood disorder. The mean duration of inpatient care was 6.2 ± 7.4 weeks, and 87% had shown considerable clinical improvement at the time of discharge.ConclusionsThe majority of female forensic patients were young adults from nuclear families. They had mood disorders, schizophrenia, and other psychotic disorders. They were referred primarily for treatment purposes. Prospective studies are required for a better characterization of the relationship between crime and psychiatric disorders.
| S-EPMC6436409 | biostudies-literature
Project description:BackgroundAtrial fibrillation (AF) and heart failure (HF) often accompany one another, and each is independently associated with poor outcomes. However, the association between AF burden and outcomes is poorly understood.ObjectiveThe purpose of this study was to describe the association between device-based AF burden and HF clinical outcomes.MethodsWe used a nationwide, remote monitoring database of cardiac implantable electronic devices (CIEDs) linked to Medicare claims. We included patients with nonpermanent AF, undergoing new CIED implant, stratified by baseline HF. The outcomes were new-onset HF, HF hospitalization, and all-cause mortality at 1 and 3 years.ResultsWe identified 39,710 patients who met inclusion criteria (25,054 with HF; 14,656 without HF). Patients with HF were younger (mean age 76.3 vs 78.5 years; P <.001), more often male (65% vs 54%; P <.001), and had higher mean CHA2DS2-VASc scores (5.4 vs 4.1; P <.001). Among those without HF, increasing device-based AF burden was significantly associated with increased risk of new-onset HF (adjusted hazard ratio [HR] 1.09 per 10% AF burden; 95% confidence interval [CI] 1.06-1.12; P <.001) and all-cause mortality (adjusted HR 1.05 per 10% AF burden; 95% CI 1.01-1.10; P = .012). Among patients with HF, increasing AF burden was significantly associated with increased risk of HF hospitalization (adjusted HR 1.05 per 10% AF burden; 95% CI 1.04-1.06; P <.001) and all-cause mortality (adjusted HR 1.06 per 10% AF burden; 95% CI 1.05-1.08; P <.001).ConclusionAmong older patients with AF receiving a CIED, increasing AF burden is significantly associated with increasing risk of adverse HF outcomes and all-cause mortality.
| S-EPMC8096675 | biostudies-literature
Project description:Background The risks associated with MRI in individuals who have implanted cardiac devices are thought to arise from the interaction between the implanted device and static, gradient, and radiofrequency magnetic fields. Purpose To determine the relationship between the peak whole-body averaged specific absorption rate (SAR) and change in magnetic field per unit time (dB/dt), maximum specific energy dose, imaging region, and implanted cardiac device characteristics and their function in patients undergoing MRI. Materials and Methods This prospective observational cohort study was conducted from October 16, 2003, to January 22, 2015 (https://ClinicalTrials.gov, NCT01130896). Any individual with an implanted cardiac device who was referred for MRI was included. Clinical MRI protocols without SAR restriction were used. Exclusion criteria were newly implanted leads, abandoned or epicardial leads, and dependence on a pacemaker with an implantable cardioverter defibrillator without asynchronous pacing capability. For each MRI pulse sequence, the calculated whole-body values for SAR, dB/dt, and scan duration were collected. Atrial and ventricular sensing, lead impedance, and capture threshold were evaluated before and immediately after (within 10 minutes) completion of each MRI examination. Generalized estimating equations with Gaussian family, identity link, and an exchangeable working correlation matrix were used for statistical analysis. Results A total of 2028 MRI examinations were performed in 1464 study participants with 2755 device leads (mean age, 67 years ± 15 [standard deviation]; 930 men [64%]). There was no evidence of an association between radiofrequency energy deposition, dB/dt, or scan duration and changes in device parameters. Thoracic MRI was associated with decreased battery voltage immediately after MRI (β = -0.008 V, P < .001). Additionally, right ventricular (RV) lead length was associated with decreased RV sensing (β = -0.012 mV, P = .05) and reduced RV capture threshold (β = -0.002 V, P < .01) immediately after MRI. Conclusion There was no evidence of an association between MRI parameters that characterize patient exposure to radiofrequency energy and changes in device and lead parameters immediately after MRI. Nevertheless, device interrogation before and after MRI remains mandatory due to the potential for device reset and changes in lead or generator parameters. © RSNA, 2020 See also the editorial by Shellock in this issue.
| S-EPMC7193917 | biostudies-literature