High-power chargers for electric vehicles: are they safe for patients with pacemakers and defibrillators?

AIMS: Battery electric vehicle (BEV) sales and use are rapidly expanding. Battery electric vehicles, along with their charging stations, are a potential source of electromagnetic interference (EMI) for patients with cardiac implantable electronic devices (CIEDs). The new 'high-power' charging stations have the potential to create strong electromagnetic fields and induce EMI in CIEDs, and their safety has not been evaluated. METHODS AND RESULTS: A total of 130 CIED patients performed 561 charges of four BEVs and a test vehicle (350 kW charge capacity) using high-power charging stations under continuous 6-lead electrocardiogram monitoring. The charging cable was placed directly over the CIED, and devices were programmed to maximize the chance of EMI detection. Cardiac implantable electronic devices were re-interrogated after patients charged all BEVs and the test vehicle for evidence of EMI. There were no incidences of EMI, specifically no over-sensing, pacing inhibition, inappropriate tachycardia detection, mode switching, or spontaneous reprogramming. The risk of EMI on a patient-based analysis is 0/130 [95% confidence interval (CI) 0%-2%], and the risk of EMI on a charge-based analysis is 0/561 (95% CI 0%-0.6%). The effective magnetic field along the charging cable was 38.65 µT and at the charging station was 77.9 µT. CONCLUSIONS: The use of electric cars with high-power chargers by patients with cardiac devices appears to be safe with no evidence of clinically relevant EMI. Reasonable caution, by minimizing the time spent in close proximity with the charging cables, is still advised as the occurrence of very rare events cannot be excluded from our results.

Better Together: Data Harmonization and Cross-Study Analysis of Abdominal MRI Data From UK Biobank and the German National Cohort.

OBJECTIVES: The UK Biobank (UKBB) and German National Cohort (NAKO) are among the largest cohort studies, capturing a wide range of health-related data from the general population, including comprehensive magnetic resonance imaging (MRI) examinations. The purpose of this study was to demonstrate how MRI data from these large-scale studies can be jointly analyzed and to derive comprehensive quantitative image-based phenotypes across the general adult population. MATERIALS AND METHODS: Image-derived features of abdominal organs (volumes of liver, spleen, kidneys, and pancreas; volumes of kidney hilum adipose tissue; and fat fractions of liver and pancreas) were extracted from T1-weighted Dixon MRI data of 17,996 participants of UKBB and NAKO based on quality-controlled deep learning generated organ segmentations. To enable valid cross-study analysis, we first analyzed the data generating process using methods of causal discovery. We subsequently harmonized data from UKBB and NAKO using the ComBat approach for batch effect correction. We finally performed quantile regression on harmonized data across studies providing quantitative models for the variation of image-derived features stratified for sex and dependent on age, height, and weight. RESULTS: Data from 8791 UKBB participants (49.9% female; age, 63 ± 7.5 years) and 9205 NAKO participants (49.1% female, age: 51.8 ± 11.4 years) were analyzed. Analysis of the data generating process revealed direct effects of age, sex, height, weight, and the data source (UKBB vs NAKO) on image-derived features. Correction of data source-related effects resulted in markedly improved alignment of image-derived features between UKBB and NAKO. Cross-study analysis on harmonized data revealed comprehensive quantitative models for the phenotypic variation of abdominal organs across the general adult population. CONCLUSIONS: Cross-study analysis of MRI data from UKBB and NAKO as proposed in this work can be helpful for future joint data analyses across cohorts linking genetic, environmental, and behavioral risk factors to MRI-derived phenotypes and provide reference values for clinical diagnostics.

Automated imaging-based abdominal organ segmentation and quality control in 20,000 participants of the UK Biobank and German National Cohort Studies.

Large epidemiological studies such as the UK Biobank (UKBB) or German National Cohort (NAKO) provide unprecedented health-related data of the general population aiming to better understand determinants of health and disease. As part of these studies, Magnetic Resonance Imaging (MRI) is performed in a subset of participants allowing for phenotypical and functional characterization of different organ systems. Due to the large amount of imaging data, automated image analysis is required, which can be performed using deep learning methods, e. g. for automated organ segmentation. In this paper we describe a computational pipeline for automated segmentation of abdominal organs on MRI data from 20,000 participants of UKBB and NAKO and provide results of the quality control process. We found that approx. 90% of data sets showed no relevant segmentation errors while relevant errors occurred in a varying proportion of data sets depending on the organ of interest. Image-derived features based on automated organ segmentations showed relevant deviations of varying degree in the presence of segmentation errors. These results show that large-scale, deep learning-based abdominal organ segmentation on MRI data is feasible with overall high accuracy, but visual quality control remains an important step ensuring the validity of down-stream analyses in large epidemiological imaging studies.

Release of high-sensitive TROPonin T by implantation of an entirely subcutaneous Implantable Cardioverter-defibrillator compared to a conventional transvenous approach: the TROPIC registry.

PURPOSE: Implantation of a subcutaneous implantable cardioverter-defibrillator (S-ICD) has become an alternative option when a conventional transvenous approach is not suitable. The myocardial damage caused by S-ICD implantation appears to be minimal despite mandatory defibrillation threshold (DFT) testing. However, there has not been a direct comparison with the traditional transvenous placement of a single-chamber ICD (VVI-ICD). The aim of this study was to determine the extent of myocardial damage by analysing the changes in serum levels of cardiac enzymes after S-ICD implantation in comparison with VVI-ICD. METHODS: In 43 patients who received an S-ICD system, differences in serum levels of high-sensitive troponin T (ΔhsTnT) and creatine kinase total (ΔCK) and muscle brain fraction (ΔCK-MB) were acquired by blood sampling before and the day after implantation. The control group consisted of 43 patients from the TropShock study who had received a transvenous VVI-ICD without DFT. RESULTS: After S-ICD implantation and testing procedure, ΔhsTnT (0.000 ng/ml, IQR - 0.003-0.002 ng/ml) was significantly lower than after conventional VVI-ICD implantation (0.018 ng/ml, IQR 0.004-0.032 ng/ml; p < 0.001). There was no significant difference in CK (ΔCKS-ICD 85.0 U/I, IQR 30.5-225.8 U/I vs ΔCKVVI-ICD 69.5 U/I, IQR 22.9-172.3 U/I; p = 0.357), but there was a significant difference in CK-MB (ΔCK-MBS-ICD of - 0.60, IQR - 2.60-1.0 vs ΔCK-MBVVI-ICD 1.0, IQR - 1.08-3.18; p = 0.030). CONCLUSION: S-ICD implantation causes less myocardial damage than VVI-ICD implantation evidenced by ΔhsTnT and ΔCK-MB.

Security millimetre wave body scanner safe for patients with leadless pacemakers or subcutaneous implantable cardioverter-defibrillators.

PURPOSE: This study was designed to evaluate the electromagnetic interference (EMI) effects and safety of the new security screening millimetre wave body scanners (MWBSs) for patients with rare cardiac implantable electronic devices (CIEDs). METHODS: We identified 73 patients with either entirely subcutaneous implantable cardioverter-defibrillators (S-ICD) or leadless pacemakers (LPM) attending routine device follow-up. CIED programming was optimised for the detection of EMI occurrence, and high-voltage therapy was disabled. Patients then underwent millimetre wave body scans under continuous ECG monitoring. Scanning was performed at the recommended distance as well as in close proximity to the scanner emulating accidental exposure. CIED function was observed for EMI effects. RESULTS: There were no episodes of inhibition of pacing in the leadless pacemaker subgroup, no oversensing in the S-ICD subgroup and no spontaneous device reprogramming in any group. There was no change in pacing or sensing thresholds, and S-ICD vector eligibility remained unchanged after scanning with the MWBS. No CIEDs were identified by the MWBS during the study. CONCLUSION: No EMI events were detected during the use of MWBSs by patients with either S-ICDs or LPMs. This data should be reassuring for patients suggesting that they can undergo security body scans without worries or disclosure of their CIED status.

Cardiac resynchronisation therapy in patients with left bundle branch block with residual conduction.

AIM: To evaluate whether left bundle branch block with residual conduction (rLBBB) is associated with worse outcomes after cardiac resynchronisation therapy (CRT). METHODS: All consecutive CRT implants at our institution between 2006 and 2013 were identified from our local device registry. Pre- and post-implant patient specific data were extracted from clinical records. RESULTS: A total of 690 CRT implants were identified during the study period. Prior to CRT, 52.2% of patients had true left bundle branch block (LBBB), 19.1% a pacing-induced LBBB (pLBBB), 11.2% a rLBBB, 0.8% a right bundle branch block (RBBB), and 16.5% had a nonspecific intraventricular conduction delay (IVCD) electrocardiogram pattern. Mean age at implant was 67.5 years (standard deviation [SD] = 10.6), mean left ventricular ejection fraction (LV EF) was 25.7% (SD = 7.9%), and mean QRS duration was 158.4 ms (SD = 32 ms). After CRT, QRS duration was significantly reduced in the LBBB (p < 0.001), pLBBB (p < 0.001), rLBBB (p < 0.001), RBBB (p = 0.04), and IVCD groups (p = 0.03). LV EF significantly improved in the LBBB (p < 0.001), rLBBB (p = 0.002), and pLBBB (p < 0.001) groups, but the RBBB and IVCD groups showed no improvement. There was no significant difference in mortality between the LBBB and rLBBB groups. LV EF post-CRT, chronic kidney disease, hyperkalaemia, hypernatremia, and age at implant were significant predictors of mortality. CONCLUSION: CRT in patients with rLBBB results in improved LV EF and similar mortality rates to CRT patients with complete LBBB. Predictors of mortality post-CRT include post-CRT LV EF, presence of CKD, hyperkalaemia, hypernatremia, and older age at implant.

Feasibility and reliability of a German guideline for farm's self-monitoring in sows and piglets.

The present study's aim was to test a German guideline for farm's self-monitoring in sows and piglets for its feasibility as well as its interobserver and test-retest reliability. The study was performed between September 2016 and April 2018 on 13 farrowing farms in Northern Germany. Contrary to the guideline, the testing was not carried out by the farmers themselves but by 2 observers with experience in pigs representing common farmers. For the interobserver reliability study, the observers performed 20 joint farm visits independently assessing the same animals. For the test-retest reliability study, each farm was visited 5 times by 1 observer (day 0, day 3, week 7, month 5, month 10). Farm visit 1 (day 0) was used as reference and compared with the remaining farm visits. The reliability was evaluated using Spearman's rank correlation coefficient (RS), intraclass correlation coefficient (ICC), and limits of agreement (LoA). As results, the guideline's feasibility was limited. The indicators' reliability also presented divergent results: All indicators in piglets revealed acceptable to good interobserver reliability (RS 0.64 to 0.77 ICC 0.33 to 0.48 LoA between the intervals -0.02 to 0.13 and -0.02 to 0.00). Contrarily, interobserver reliability was low for indicators in sows (e.g., claw alterations: RS -0.41 ICC 0.00 LoA -0.97 to 0.68). Overall acceptable test-retest reliability could be assigned to all indicators although no exact agreement existed but only the pursuit of trends is indicated. On the basis of the present results, the guideline in its present form cannot be recommended for farms' self-monitoring. Given the restricted applicability, it should be reconsidered whether it might not be more appropriate to use scientifically tested and generally accepted animal welfare assessment systems such as the Welfare Quality animal welfare assessment protocols, although their application is also time-consuming.

Incidence of magnet mode in patients with implantable cardioverter defibrillators.

PURPOSE: To determine the current incidence of antitachycardia therapy suspension due to magnet reversion in patients with implantable cardioverter defibrillators (ICDs). METHODS: From March 2012 to September 2018, all St. Jude Medical ICD interrogations performed at the Deutsches Herzzentrum München were screened for stored events of antitachycardia therapy suspension caused by static magnetic fields (flux densities ≥ 1 mT as defined in St. Jude Medical ICDs) affecting the giant magnetoresistance (GMR) sensor. Intentional ICD deactivation or inappropriate magnet application in the hospital was classified as non-environmental electromagnetic interference (EMI) whereas in the case of any other stored magnet reversion, the event was classified as presumably environmental EMI. RESULTS: Data from 201 St. Jude Medical ICD patients (mean age 62 ± 24 years, 165 males/36 females) were included in the analysis. ICD interrogations occurred at a mean follow-up of 25.1 months ± 15.6 months and summed up to a total of 464 patient-years of follow-up. A total number of 43 magnet reversion events were detected in 21 patients. Thirty-two events in 13 patients were presumably related to environmental EMI sources. Suspension of antitachycardia therapy only occurred in a temporary fashion. None of the patients experienced any ventricular tachyarrhythmia during ICD inhibition. The incidence of antitachycardia therapy suspension due to magnet reversion related to presumably environmental EMI sources was 6.9% per patient and year. CONCLUSION: Although none of the patients experienced any harmful event, antitachycardia therapy suspension due to magnet reversion is a common issue. Patients should be well-educated about potential EMI sources as well as trained in handling them.

Test-Retest Reliability of the 'Welfare Quality® Animal Welfare Assessment Protocol for Sows and Piglets'. Part 1. Assessment of the Welfare Principle of 'Appropriate Behavior'.

The present study's aim was to assess the test-retest reliability (TRR) of the 'Welfare Quality® animal welfare assessment protocol for sows and piglets' focusing on the welfare principle 'appropriate behavior'. TRR was calculated using Spearman's rank correlation coefficient (RS), intraclass correlation coefficient (ICC), smallest detectable change (SDC), and limits of agreement (LoA). Principal component analysis (PCA) was used for deeper analysis of the Qualitative Behavior Assessment (QBA). The study was conducted on thirteen farms in Northern Germany, which were visited five times by the same observer. Farm visits 1 (F1; day 0) were compared to farm visits 2 to 5 (F2-F5). The QBA indicated no TRR when applying the statistical parameters introduced above (e.g., 'playful' (F1-F4) RS 0.08 ICC 0.00 SDC 0.50 LoA [-0.62, 0.38]). The PCA detected contradictory TRR. Acceptable TRR could be found for parts of the instantaneous scan sampling (e.g., negative social behavior (F1-F3) RS 0.45 ICC 0.37 SDC 0.02 LoA [-0.03, 0.02]). The human-animal relationship test solely achieved poor TRR, whereas scans for stereotypies showed sufficient TRR (e.g., floor licking (F1-F4) RS 0.63 ICC 0.52 SDC 0.05 LoA [-0.08, 0.04]). Concluding, the principle 'appropriate behavior' does not represent TRR and further investigation is needed before implementation on-farm.

Test-retest reliability of the Welfare Quality Assessment protocol for pigs applied to sows and piglets. Part 2. Assessment of the principles good feeding, good housing, and good health1.

The present study aimed at testing the feasibility and on-farm test-retest reliability of the Welfare Quality Assessment protocol for pigs applied to sows and piglets. The study was conducted on 13 farms in Northern Germany, which were visited 5 times by the same observer, and included 2 experimental setups: first, the complete Welfare Quality Assessment protocol for sows and piglets was applied to the farms. Second, additional assessments in the gestation unit considered all sows. The complete protocol assessments were used to evaluate the feasibility of the protocol. Furthermore, the data were analyzed with regard to on-farm test-retest reliability. The present publication focuses on the Welfare Quality principles good feeding, good housing, and good health, which are based on individual indicators (IN). The second experimental setup was utilized to verify the test-retest reliability of IN in the gestation unit with an increased number of animals under assessment. The test-retest reliability was calculated using Spearman's rank correlation coefficient (RS), intraclass correlation coefficient (ICC), smallest detectable change (SDC), and limits of agreement (LoA). Farm visit 1 (F1; day 0) was set as a reference and compared with farm visits 2 to 5 (F2 to 5; day 3, week 7, month 5, month 10). The IN of the above-named Welfare Quality principles achieved mostly acceptable test-retest reliability (e.g., wounds on the body F1 to F4: RS 0.34 to 0.57, ICC 0.40 to 0.41, SDC 0.02 to 0.12, LoA [-0.03; 0.02] to [-0.09; 0.14]) in terms of the on-farm test-retest reliability. Poor test-retest reliability was detected for body condition score concerning the principle good feeding, for bursitis and panting in sows and for huddling and panting in piglets within the principle good housing, and finally for vulva lesions, metritis, and local infections in sows and for scouring and lameness in piglets in the principle good health. Variations among the farm visits, which resulted in poor test-retest reliability, may be explained by seasonal effects (panting), moving animals (bursitis, lameness, huddling), rare occurrences of diseases (metritis, local infections, scouring), and differently conditioned sow groups (body condition score). The second experimental setup confirmed the results for IN in the gestation unit. Thus, the reported test-retest reliability determines the Welfare Quality Assessment protocol for sows and piglets to be a reliable approach to assess welfare in sows and piglets.

[Hygienic Inspections of Ventilation Systems Under Resting Conditions (According to DIN 1946-4:1999-03) - A Retrospective Assessment]. / Hygienische Abnahmeprüfungen raumlufttechnischer Anlagen unter Ruhebedingungen nach DIN 1946-4:1999-03 ­ eine retrospektive Auswertung.

BACKGROUND: Hygienic and microbiologically sterile air quality is essential for successful guideline-based work in operating theatres. To ensure clean air and to reduce contamination during surgery, ventilation systems are indispensable. Ventilation systems should be especially designed to keep the number of particles and germs under statutory limits. Therefore, they must be operated to recognised standards of good practice and be periodically inspected and maintained. The objective of this study was to prove, through the analysis of observation outside surgery time (rest condition), the effects of ventilation systems on air quality in a medical facility. METHODS: Measurements were taken in 34 operating theatres annually over a period of ten years outside surgery time (resting condition) but with the air ventilation system operating under full load. 29 operating theatres were provided with laminar air flow and five theatres with turbulent air flow systems. In each operating theatre, air cleanliness was analysed by measuring the amount of airborne particles and airborne germs. Measuring points were determined 10 mm beneath the supply-air ceiling in the centre of the operating theatre and at one position outside the supply-air ceiling. RESULTS: The number of airborne particles at the supply-air ceiling was between 0/m³ and 4,441/m³ of air and, as such, the limiting factor was never exceeded. However, airborne germ measurements of between 0 CFU/m³ and 200 CFU/m³ (CFU: colony forming units) demonstrated that the limiting factor for this criterion was exceeded in 10.9% of occasions. In general, the values in the middle of the room were higher than at the supply-air ceiling. There were significant differences (p < 0.001) between the values at the supply-air ceiling, the surgery table and the values outside the supply-air ceiling. CONCLUSIONS: The results show the positive impact of ventilation systems on the air cleanliness in operating theatres. However, laminar airflow systems seem to create cleaner air than conventional ventilation systems. The size of the supply-air ceiling plays an important role in the prevention of the contamination of the staff, the surgical field, the instrument table and the patient. However, the effect on surgical site infections has not been verified. Improved measuring methods should be considered.

Combined gracilis tendon autograft reconstruction and discus repair of a chronic anterior-superior sternoclavicular joint dislocation.

A case of an 18-year-old gardener who sustained an anterior-superior dislocation of the sternoclavicular joint while playing handball and falling on his right shoulder is presented. Non-surgical treatment failed, and the patient could willingly dislocate the right clavicle while abduction and external rotation of the arm. This painful condition was finally treated with surgical reconstruction of the sternoclavicular joint using gracilis tendon autograft and repair of the discus. Level of evidence Therapeutic study, case report and technical note, Level IV.