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.

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.

Pulsed field ablation in patients with cardiac implantable electronic devices: an ex vivo assessment of safety.

BACKGROUND: Pulse field ablation (PFA) is a novel catheter ablation technology with potential safety benefits due to its tissue selectivity. It has the potential to directly damage or interact with the functionality of cardiac implantable electronic devices (CIEDs) in the form of electromagnetic interference (EMI). The aim of our study was to assess the impact of PFA on CIEDs. METHODS: PFA lesions (45 per CIED) were applied from the Farapulse system to CIEDs (< 5 cm from the lead tip and < 15 cm from the generator). All devices were checked before and after PFA application for proper sensing and pacing functionality as well as for integrity of shock circuits in ICDs using a heart simulator. Moreover, devices were then interrogated for any spontaneous reprogramming, mode switching or other EMI effects. RESULTS: In total, 44 CIEDs were tested (16 pacemaker, 21 ICDs, 7 CRT-P/D) with 1980 PFA applications. There was no change in device settings, functionality and electrical parameters, and there was no macroscopic damage to the devices. The risk of damage to the electric components or leads on a patient-based analysis is 0/44 (95% CI 0-8%) and on a PFA pulse-based analysis is 0/1980 (95% CI 0-0.2%). Clinically relevant EMI appeared with oversensing and pacing inhibition but not tachycardia detection. CONCLUSIONS: Bipolar PFA appears safe and does not result in damage to CIEDs or leads. Clinically relevant EMI does occur, but appropriate peri-procedural programming may mitigate this. In vivo studies are needed to confirm our findings.

Deep sedation with propofol in patients undergoing left atrial ablation procedures-Is it safe?

Background: Catheter ablation for atrial fibrillation (AF) or left atrial tachycardia is well established. To avoid body movement and pain, sedative and analgesic agents are used. Objective: The aim was to investigate safety of sedation/anti-pain protocol administered by electrophysiology (EP) staff. Methods: A total of 3211 consecutive patients (61% male) undergoing left atrial ablation for paroxysmal AF (37.1%), persistent AF (35.3%) or left atrial tachycardia (27.6%) were included. Midazolam, fentanyl, and propofol were administered by EP staff. In case of respiratory depression, endotracheal intubation (eIT) or noninvasive ventilation (NIV) was implemented. Risk factors for eIT or NIV were analyzed. Results: Mean doses of propofol, midazolam, and fentanyl were 33.7 ± 16.7 mg, 3 ± 11.1 mg, and 0.16 ± 2.2 mg, respectively. Norepinephrine was administered in 396 of 3211 patients (12.3%) because of blood pressure drop (mean arterial pressure <60 mm Hg). NIV was necessary in 47 patients (1.5%) and eIT in 1 patient (0.03%). Procedure duration, high body mass index (BMI), high CHADS2-VASC2 score, high age, low glomerular filtration rate, diabetes mellitus, and low baseline oxygen saturation were associated with NIV or eIT. The only independent predictor for NIV/eIT was high BMI (>30.1 ± 9.0 kg/m2). Therefore, patients with a BMI of ≥30 had a 40% higher risk for the need of NIV/eIT during the procedure in our study. Conclusion: Sedation/anti-pain control including midazolam, propofol, and fentanyl administered by EP staff is safe, with only 1.53% requirement of NIV/eIT. High BMI (>30 kg/m2) emerged as an independent predictor for eIT/NIV.

Role of the Ambulatory Assessed Apnea-Hypopnea Index for Predicting Recurring Atrial Fibrillation After Ablation Therapy.

Catheter ablation is an effective treatment for atrial fibrillation (AF). Obstructive sleep apnea (OSA) is a known risk factor for recurrent AF. The apnea-hypopnea index (AHI) is a measurement tool to screen patients for OSA. We sought to evaluate if the ambulatory assessed AHI is associated with AF recurrence following AF catheter ablation. 187 patients with paroxysmal (n = 155) or early persistent (n = 32) AF presenting for catheter ablation were included in the study. AHI was determined prior to ablation using an ambulatory screening device. All patients underwent pulmonary vein isolation (PVI). In patients with early persistent AF (17%) additional ablation of complex fractionated atrial electrograms (CFAE) was performed. Clinical follow-up was available after 3 and 12 months including 7-day Holter-ECG. All 187 patients (60.3 ± 11.4 years, 64.2% male) completed the 3 months follow-up and 170 patients the 12 months follow-up. A pathological AHI ≥15 was found in 45/187 (24.1%) patients. Additional CFAE did not differ between patients with an AHI ≥15 and AHI <15 (p = 0.663). After 3 months, 12/41 (29.3%) patients with AHI ≥15 showed recurrent AF compared to 24/146 (16.4%) patients with AHI <15 (p = 0.066). After 12 months, AHI ≥15 was associated with a significant higher rate of AF recurrence of 47.4% (18/38) versus 26.5% (35/132) in patients with AHI <15 (p = 0.014). In the logistic regression analysis AHI ≥15 was an independent predictor of recurrent AF at 12 months (p = 0.011). In conclusion, ambulatory assessed AHI ≥15 is associated with increased risk for AF recurrence following catheter ablation. OSA screening should be performed in AF patients as it might influence catheter ablation success.

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.

Patients with pacemakers or defibrillators do not need to worry about e-Cars: An observational study.

BACKGROUND: Electric cars are increasingly used for public and private transportation and represent possible sources of electromagnetic interference (EMI). Potential implications for patients with cardiac implantable electronic devices (CIED) range from unnecessary driving restrictions to life-threatening device malfunction. This prospective, cross-sectional study was designed to assess the EMI risk of electric cars on CIED function. METHODS: One hundred and eight consecutive patients with CIEDs presenting for routine follow-up between May 2014 and January 2015 were enrolled in the study. The participants were exposed to electromagnetic fields generated by the four most common electric cars (Nissan Leaf, Tesla Model S, BMW i3, VW eUp) while roller-bench test-driving at Institute of Automotive Technology, Department of Mechanical Engineering, Technical University, Munich. The primary endpoint was any abnormalities in CIED function (e.g. oversensing with pacing-inhibition, inappropriate therapy or mode-switching) while driving or charging electric cars as assessed by electrocardiographic recordings and device interrogation. RESULTS: No change in device function or programming was seen in this cohort which is representative of contemporary CIED devices. The largest electromagnetic field detected was along the charging cable during high current charging (116.5 µT). The field strength in the cabin was lower (2.1-3.6 µT). CONCLUSIONS: Electric cars produce electromagnetic fields; however, they did not affect CIED function or programming in our cohort. Driving and charging of electric cars is likely safe for patients with CIEDs.

Myocardial Minimal Damage After Rapid Ventricular Pacing - the prospective randomized multicentre MyDate-Trial.

Therapy of choice for the primary and secondary prevention of sudden cardiac death is the implantation of an implantable cardioverter defibrillator (ICD). Whereas appropriate and inappropriate ICD shocks lead to myocardial microdamage, this is not known for antitachycardia pacing (ATP). In total, 150 ICD recipients (66 ± 12 years, 81.3% male, 93.3% primary prevention, 30.0% resynchronization therapy) were randomly assigned to an ICD implantation with or without intraoperative ATP. In the group with ATP, the pacing maneuver was performed twice, each time applying 8 impulses à 6 Volt x 1.0 milliseconds to the myocardium. High sensitive Troponin T (hsTnT) levels were determined prior to the implantation and thereafter. There was no significant difference in the release of hsTnT between the two randomization groups (delta TnT without ATP in median 0.010 ng/ml [min. -0.016 ng/ml-max. 0.075 ng/ml] vs. with ATP in median 0.013 ng/ml [min. -0.005-0.287 ng/ml], p = 0.323). Setting a hsTnT cutoff of 0.059 ng/dl as a regularly augmented postoperative hsTnT level, no relevant difference between the two groups regarding the postoperative hsTnT levels above this cutoff could be identified (without ATP n = 10 [14.7%] vs. with ATP n = 16 [21.9%], p = 0.287). There was no significant difference in the release of high sensitive Troponin between patients without intraoperative ATP compared to those with intraoperative ATP. Hence, antitachycardia pacing does not seem to cause significant myocardial microdamage. This may further support its use as a painless and efficient method to terminate ventricular tachycardia in high-risk patients.

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.

The incidence, indications and predictors of acute pacemaker implantation after ablation of persistent atrial fibrillation.

INTRODUCTION: Patients with persistent atrial fibrillation (AF) may additionally suffer from a concealed sinus node disease. We sought to determine the incidence, indications and predictors of acute pacemaker [PM] implantation within 1 week after the ablation of persistent AF. METHODS AND RESULTS: We performed a retrospective analysis of patients, who had had an ablation of persistent AF at our center. Between 01/2011 and 08/2016, 1234 patients (mean age 65 ± 10 years, 66.7% male) without prior PM implantation underwent an ablation of persistent AF. Pulmonary vein isolation (PVI) was performed in 1158 (93.8%), the additional ablation of complex fractionated atrial electrograms (CFAE) in 1109 (89.9%) and linear ablation in 524 (42.5%) patients. Temporary cardiac pacing was necessary in 27 (2.2%) patients. The temporary PM was removed in 15 patients (1.2%) because sinus node recovered after a median of 1.0 (minimum 0.1-maximum 2.0) day. The remaining 12 (1.0%) patients required the implantation of a permanent PM. Another 13 (1.1%) patients required permanent PM implantation without prior temporary pacing. In a multivariable regression model, age [OR 1.07 (1.02-1.12), p = 0.006], sinus pauses prior to ablation [OR 7.97 (2.36-26.88), p = 0.001] and atria with low voltage [OR 2.83 (1.31-6.11), p = 0.008] were identified as significant predictors for acute cardiac pacing. CONCLUSION: Acute cardiac pacing within 1 week after the ablation of persistent AF was necessary in 40 (3.2%) patients. Age, sinus pauses in history prior to ablation and the existence of low-voltage areas in the atria were identified as relevant risk factors.

Pacemaker Implantation Associated Myocardial Micro-Damage: A Randomised Comparison between Active and Passive Fixation Leads.

Fixation of the pacemaker leads during pacemaker implantation leads to an increase of cardiac Troponin T (cTnT) that can be interpreted as a sign of minimal myocardial damage. This trial evaluates whether the mechanism type of lead fixation influences the magnitude of cTnT release. Patients having a de-novo cardiac pacemaker implantation or a lead revision were centrally randomized to receive either a ventricular lead with an active (screw) or passive (tine) fixation mechanism. High-sensitive Troponin T (hsTnT) was determined on the day of the procedure beforehand and on the following day. 326 Patients (median age (IQR) 75.0 (69.0-80.0) years, 64% male) from six international centers were randomized to receive ventricular leads with an active (n = 166) or passive (n = 160) fixation mechanism. Median (IQR) hsTnT levels increased by 0.009 (0.004-0.021) ng/ml in the group receiving screw-in ventricular leads and by 0.008 (0.003-0.030) ng/ml in the group receiving tined ventricular leads (n.s.). In conclusion pacemaker implantations are followed by a release of hsTnT. The choice between active or passive fixation ventricular leads does not have a significant influence on the extent of myocardial injury and the magnitude of hsTnT release.

The impact of multipole pacing on left ventricular function in patients with cardiac resynchronization therapy - A real-time three-dimensional echocardiography approach.

BACKGROUND: Cardiac resynchronization therapy (CRT) is standard of care in heart failure (HF), however this technique is associated with a non-responder rate of 30%. Multipole pacing (MPP) with a quadripolar lead may optimize CRT and responder rate by creating two electrical wave fronts in the left ventricular (LV) myocardium simultaneously in order to reduce mechanical dyssynchrony. The objective of this study was to investigate the acute impact of MPP on LV function by assessing systolic dyssynchrony index (SDI) and left ventricular ejection fraction (LVEF) via real-time three-dimensional echocardiography (RT3DE). METHODS: In 41 consecutive patients (87.8% male; mean age 66.0 ±â€¯12.7 years) who received CRT defibrillators with a quadripolar LV lead, RT3DE datasets were acquired the day after implantation under the following pacing configurations: Baseline AAI, conventional biventricular pacing using distal or proximal LV poles and MPP. Datasets were analyzed in paired samples evaluating SDI and LVEF depending on programmed pacing modality. RESULTS: MPP resulted in statistically significant reduction of SDI compared to baseline (6.3%; IQR 4.4-7.8 and 9.9%; IQR 8.0-12.7; p < 0.001) and to conventional biventricular pacing using distal (7.6%; IQR 6.5-9.1; p < 0.001) or proximal (7.4%; IQR 6.2-8.8; p < 0.001) LV poles respectively. MPP yielded significant increase in LVEF compared to baseline (30.6%; IQR 25.8-37.5 and 27.2%; IQR 21.1-33.6; p < 0.001) and to conventional biventricular pacing configuration with distal (28.1%; IQR 22.1-34.5; p < 0.001) or proximal (28.6%; IQR 23.2-34.9; p < 0.001) LV poles respectively. CONCLUSIONS: Multipole pacing improves mechanical dyssynchrony of the left ventricular myocardium as assessed by SDI and LVEF.

Biomarker-based diagnosis of pacemaker and implantable cardioverter defibrillator pocket infections: A prospective, multicentre, case-control evaluation.

BACKGROUND: The use of cardiac implantable electronic devices (CIED) has risen steadily, yet the rate of cardiac device infections (CDI) has disproportionately increased. Amongst all cardiac device infections, the pocket infection is the most challenging diagnosis. Therefore, we aimed to improve diagnosis of such pocket infection by identifying relevant biomarkers. METHODS: We enrolled 25 consecutive patients with invasively and microbiologically confirmed pocket infection. None of the patients had any confounding conditions. Pre-operative levels of 14 biomarkers were compared in infected and control (n = 50) patients. Our selected biomarkers included white blood cell count (WBC), C-reactive protein (CRP), procalcitonin (PCT), lipopolysaccharide binding protein, high-sensitivity C-reactive protein (HS-CRP), polymorphonuclear-elastase, presepsin, various interleukins, tumor necrosis factor α (TNF-α), and granulocyte macrophage colony-stimulating factor (GM-CSF). RESULTS: Of the 25 patients with isolated pocket infection (70±13years, 76% male, 40% ICDs), none presented with leukocytosis. In contrast, they had higher serum levels of HS-CRP (p = 0.019) and PCT (p = 0.010) than control patients. Median PCT-level was 0.06 ng/mL (IQR 0.03-0.07 ng/mL) in the study group versus 0.03 ng/mL (IQR 0.02-0.04 ng/mL) in controls. An optimized PCT cut-off value of 0.05 ng/mL suggests pocket infection with a sensitivity of 60% and specificity of 82%. In addition TNF-α- and GM-CSF-levels were lower in the study group. Other biomarkers did not differ between groups. CONCLUSION: Diagnosis of isolated pocket infections requires clinical awareness, physical examination, evaluation of blood cultures and echocardiography assessment. Nevertheless, measurement of PCT- and HS-CRP-levels can aid diagnosis. However, no conclusion can be drawn from normal WBC-values. CLINICAL TRIAL REGISTRATION: clinicaltrials.gov identifier: NCT01619267.