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.

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.

Cardiologist-Directed Sedation Management in Patients Undergoing Transvenous Lead Extraction: A Single-Centre Retrospective Analysis.

BACKGROUND: The demand for transvenous lead extraction (TLE) has increased. In line with this, the safety of such procedures has also increased. Traditionally, TLE is performed under resource-intensive general anaesthesia. This study aims to evaluate the safety and outcomes of Cardiologist-lead deep sedation for TLE. METHODS: We retrospectively analysed 328 TLE procedures performed under deep sedation from 2016 to 2019. TLE procedures were performed by experienced electrophysiologists. Sedation was administered by a specifically trained cardiologist (bolus midazolam/fentanyl and propofol infusion). Procedural sedation data including blood pressure, medication administration and sedation time were collected. Complications related to sedation and the operative component of the procedure were analysed retrospectively. RESULTS: The sedation-associated complication rate during TLE was 22.0%. The most common complication (75% of complications) was hypotension requiring noradrenaline, followed by bradycardia requiring atropine (13% of complications). Additionally, the unplanned presence of an anaesthesiologist was needed in one case (0.3%). Deep sedation was achieved with midazolam (mean dose 42.9 ± 26.5 µg/kg), fentanyl (mean dose 0.4 ± 0.6 µg/kg) and propofol (mean dose 3.5 ± 1.2 mg/kg/h). There was no difference in medication dosage between those with a sedation-associated complication and those without. Sedation-associated complications appeared significantly more in patients with reduced LVEF (p = 0.01), renal impairment (p = 0.01) and a higher American Society of Anaesthesiologists (ASA) class (p = 0.01). CONCLUSION: Deep sedation for TLE can be safely performed by a specifically trained cardiologist, with a transition to general anaesthesia required in only 0.3% of cases. We continue to recommend the on-call availability of an anaesthesiologist and cardiac surgeon in case of major complications.

Patient Characteristics, Procedural Characteristics, and Outcomes in Patients Having Lead Extraction in a High-Volume Center.

The rate of transvenous lead extraction (TLE) is increasing, with an increasing rate of complex devices being implanted. TLE is now a routine part of cardiac device management and up-to-date data on the safety and efficacy of TLE with modern tools and techniques is essential to management decisions regarding noninfectious indications for lead extraction. We present a contemporary, prospective review of TLE at our high-volume cardiac center. All patients who underwent TLE from June 2016 to June 2019 were enrolled in our local database, and baseline clinical data, procedural information, and outcome data were collected. In total, 561 leads were explanted (n = 153) or extracted (n = 408) from 341 patients over the study period. Patients were predominantly male (71%), with a mean age of 65 ± 17 years. The most common indication for lead removal was lead failure (45.2%, n = 154), followed by infection of the pocket or device (29.3%, n = 100). In total, complete success was achieved in 96.4% (n = 541) leads, clinical success in a further 2.1% (n = 12), and failure only in 1.4% (n = 8). There was an overall complication rate of 0.9% (3/341) for major complications and 1.5% (5/341) for minor complications. There were no deaths. In conclusion, our data suggest that there are ongoing improvements in the safety profile and success rates of lead extraction undertaken by experienced operators. The major complication rate now is <1%.

A prospective case-control validation of procalcitonin as a biomarker diagnosing pacemaker and implantable cardioverter-defibrillator pocket infection.

BACKGROUND: The diagnosis of device infections, especially pocket infections, is challenging and relies primarily on clinical presentation. The prospective DIRT (Device associated Infections Role of new diagnostic Tools) study identified procalcitonin (PCT) as the most promising biomarker among other 14 biomarkers to aid the diagnosis of pocket infection. It also identified an optimized cut-off value of 0.05 ng/ml for a localized generator pocket infection. AIMS: The present study aims to validate the proposed PCT cut-off value of 0.05 ng/ml for the diagnosis of pocket infection in an independent cohort. METHODS: We prospectively enrolled 81 patients with pocket infections and 81 controls matched for age and renal function presenting for elective device exchange or lead revision. Patients with concomitant infectious or inflammatory diseases, end-stage renal failure, current active malignancy, or receiving immunosuppressive therapy were excluded. RESULTS: An elevated PCT over 0.05 ng/ml was found in 68% (n = 55) of pocket infections and 24% (n = 19) of controls, corresponding to a sensitivity of 68% and a specificity of 77% for diagnosing a pocket infection. In receiver operating characteristic (ROC) analysis, PCT showed an area under the curve of 0.75 (95% confidence interval, 0.68-0.83; P < 0.001). Sensitivity remained high with antibiotic pretreatment (65% compared to 69% without pretreatment) and in cases with minimal inflammatory signs (67% compared to 70% with extensive inflammation). CONCLUSION: Our study validates the cut-off value of 0.05 ng/ml PCT for diagnosis of a pocket infection, even in patients pre-treated with antibiotics or with minimal clinical signs of inflammation.

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.

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.

[Optimisation of subcutaneous defibrillator programming after inappropriate shocks due to new onset of right bundle branch block]. / Optimierung der Geräteeinstellung eines subkutanen Defibrillators nach inadäquaten Schocks durch neu aufgetretenen Rechtsschenkelblock.

The subcutaneous implantable defibrillator (S-ICD) has become an established tool for the prevention of sudden cardiac death. Based on its detection properties, the S­ICD is essentially dependent on correct morphology discrimination of the QRS complex and avoidance of potential T­wave sensing. We report on a patient who experienced multiple inappropriate S­ICD shocks due to T­wave oversensing in the setting of new onset of right bundle branch block. Strategies for the optimisation of the device programming are discussed.