The point on the treatment of arrhythmic storm.

Arrhythmic storm is a clinical emergency associated with high mortality, which requires multi-disciplinary management. Reprogramming of the implantable cardiac defibrillator (ICD) aimed at reducing shocks, adrenergic blockade using beta-blockers, sedation/anxiolysis, and blockade of the stellate ganglion represent the first simple and effective manoeuvres, but further suppression of arrhythmias with antiarrhythmics is often required. A low-risk patient (e.g. monomorphic ventricular tachycardia, functioning ICD, and haemodynamically stable) should be managed with a beta-blocker (possibly non-selective) plus amiodarone, in addition to sedation with a benzodiazepine or dexmedetomidine; in patients at greater risk (high burden and haemodynamic instability), autonomic modulation with blockade of the stellate ganglion and the addition of a second antiarrhythmic (lidocaine) should be considered. In patients refractory to these measures, with advanced heart failure, general anaesthesia with intubation and the establishment of a haemodynamic circulatory support should be considered. Ablation, performed early, appears to be superior in terms of mortality and reduction of future shocks compared with titration of antiarrhythmics.

Cardiac Magnetic Resonance and Cardiac Implantable Electronic Devices: Are They Truly Still "Enemies"?

The application of cardiac magnetic resonance (CMR) imaging in clinical practice has grown due to technological advancements and expanded clinical indications, highlighting its superior capabilities when compared to echocardiography for the assessment of myocardial tissue. Similarly, the utilization of implantable cardiac electronic devices (CIEDs) has significantly increased in cardiac arrhythmia management, and the requirements of CMR examinations in patients with CIEDs has become more common. However, this type of exam often presents challenges due to safety concerns and image artifacts. Until a few years ago, the presence of CIED was considered an absolute contraindication to CMR. To address these challenges, various technical improvements in CIED technology, like the reduction of the ferromagnetic components, and in CMR examinations, such as the introduction of new sequences, have been developed. Moreover, a rigorous protocol involving multidisciplinary collaboration is recommended for safe CMR examinations in patients with CIEDs, emphasizing risk assessment, careful monitoring during CMR, and post-scan device evaluation. Alternative methods to CMR, such as computed tomography coronary angiography with tissue characterization techniques like dual-energy and photon-counting, offer alternative potential solutions, although their diagnostic accuracy and availability do limit their use. Despite technological advancements, close collaboration and specialized staff training remain crucial for obtaining safe diagnostic CMR images in patients with CIEDs, thus justifying the presence of specialized centers that are equipped to handle these type of exams.

Diagnostic evaluation of unexplained ventricular tachyarrhythmias in younger adults.

BACKGROUND: The diagnostic work-up for cardiac arrest from ventricular tachyarrhythmias occurring in younger adults and structurally normal hearts is variable and often incomplete. METHODS: We reviewed records for all recipients of a secondary prevention implantable cardiac defibrillator (ICD) younger than 60 years at a single quaternary referral hospital from 2010 to 2021. Patients with unexplained ventricular arrhythmias (UVA) were identified as those with no structural heart disease on echocardiogram, no obstructive coronary disease, and no clear diagnostic features on ECG. We specifically evaluated the adoption rate of five modalities of "second-line" cardiac investigations: cardiac magnetic resonance imaging (CMR), exercise ECG, flecainide challenge, electrophysiology study (EPS), and genetic testing. We also evaluated patterns of antiarrhythmic drug therapy and device-detected arrhythmias and compared them with secondary prevention ICD recipients with a clear etiology found on initial assessment. RESULTS: One hundred and two recipients of a secondary prevention ICD under the age of 60 were analyzed. Thirty-nine patients (38.2%) were identified with UVA and were compared with the remaining 63 patients with VA of clear etiology (61.8%). UVA patients were younger (35.6 ± 13.0 vs. 46.0 ± 8.6 years, p < .001) and were more often female (48.7% vs. 28.6%, p = .04). CMR was performed in 32 patients with UVA (82.1%), whereas flecainide challenge, stress ECG, genetic testing, and EPS were only performed in a minority of patients. Overall, the use of a second-line investigation suggested an etiology in 17 patients with UVA (43.5%). Compared to patients with VA of clear etiology, UVA patients had lower rates of antiarrhythmic drug prescription (64.1% vs. 88.9%, p = .003) and had a higher rate of device-delivered tachy-therapies (30.8% vs. 14.3%, p = .045). CONCLUSION: In this real-world analysis of patients with UVA, the diagnostic work-up is often incomplete. While CMR was increasingly utilized at our institution, investigations for channelopathies and genetic causes appear to be underutilized. Implementation of a systematic protocol for work-up of these patients requires further study.

Clinical outcomes of subcutaneous implantable cardiac defibrillator implantation - Iran SICD registry.

BACKGROUND: The subcutaneous implantable-defibrillator (S-ICD) is a relatively new alternative to the transvenous ICD system to minimize intravascular lead-related complications. This paper presents outcome of SICD implantation in patients enrolled in Iran S-ICD registry. METHODS: Between October 2015 and June 2022, this prospective multicenter national registry included 223 patients with a standard indication for an ICD, who neither required bradycardia pacing nor needed cardiac resynchronization to evaluate the early post-implant complications and long-term follow-up results of the S-ICD system. RESULTS: The mean age of the patients was 45 ± 17 years. The majority (79.4%) were male. Ischemic cardiomyopathy (39.5%) was the most common underlying disorder among patients selected for S-ICD implant. Most study patients (68.6%) had ICD for primary prevention of sudden cardiac death. Seven patients (3.1%) were found to have suboptimal lead positions. Six patients (2.7%) developed a pocket hematoma; all were managed medically. During a mean follow-up of 2 years, the appropriate therapy was recorded in 13% of the patients and inappropriate ICD intervention mainly due to supraventricular tachycardia in 8.9%. Pocket infection was observed in four patients (1.8%) and five patients (2.2%) died mainly due to heart failure. CONCLUSION: S-ICDs were effective at detecting and treating both induced and spontaneous ventricular arrhythmias. Major clinical complications were rare.

Role of deep learning methods in screening for subcutaneous implantable cardioverter defibrillator in heart failure.

INTRODUCTION: S-ICD eligibility is assessed at pre-implant screening where surface ECG traces are used as surrogates for S-ICD vectors. In heart failure (HF) patients undergoing diuresis, electrolytes and fluid shifts can cause changes in R and T waves. Subsequently, T:R ratio, a major predictor of S-ICD eligibility, can be dynamic. METHODS: This is a prospective study of patients with structurally normal hearts and HF patients undergoing diuresis. All patients were fitted with Holters® to record their S-ICD vectors. Our deep learning model was used to analyze the T:R ratios across the recordings. Welch two sample t-test and Mann-Whitney U were used to compare the data between the two groups. RESULTS: Twenty-one patients (age 58.43 ± 18.92, 62% male, 14 HF, 7 normal hearts) were enrolled. There was a significant difference in the T:R ratios between both groups. Mean T: R was higher in the HF group (0.18 ± 0.08 vs 0.10 ± 0.05, p < .001). Standard deviation of T: R was also higher in the HF group (0.09 ± 0.05 vs 0.07 ± 0.04, p = .024). There was no difference between leads within the same group. CONCLUSIONS: T:R ratio, a main determinant for S-ICD eligibility, is higher and has more tendency to fluctuate in HF patients undergoing diuresis. We hypothesize that our novel neural network model could be used to select HF patients eligible for S-ICD by better characterization of T:R ratio reducing the risk of T-wave over-sensing (TWO) and inappropriate shocks. Further work is required to consolidate our findings before applying to clinical practice.

Contact allergy to a subcutaneous implantable cardiac defibrillator - A rare problem with a golden solution.

Contact allergy to implantable cardiac defibrillators (ICD) is an uncommon and underdiagnosed complication. We report a case of a 20-years-old man patient that was resuscitated from sudden cardiac death. Workup imaging study was unremarkable, but genetic testing identified a mutation in the KCNH2 gene of uncertain significance. The patient underwent a subcutaneous implantable cardiac defibrillator (S-ICD) implantation, with no complications. The patient suffered two hospital re-admissions due to a device-related inflammatory reaction, leading to two device re-implantations. At the first time, it was considered a bacterial infection and the S-ICD was replaced by an endovascular device. At the second time, a tissue-device interaction, with hypersensitivity reaction and device rejection was suspected. The skin patch-tests were inconclusive, but it was decided to implant a custom-made gold-coated endovascular ICD. Indeed, the tendency is an initial misdiagnosis as an infection and a high clinical suspicion is essential to an early diagnosis.

Predictors of appropriate implantable cardiac defibrillator therapy in cardiac sarcoidosis.

BACKGROUND: Cardiac sarcoidosis (CS) is associated with an increased risk for sudden cardiac death. An implantable cardiac defibrillator (ICD) is recommended in a subgroup of CS patients. However, the recommendations for primary prevention differ between guidelines. The purpose of the study was to evaluate the efficacy and safety of ICDs in CS and to identify predictors of appropriate therapy. METHODS: A retrospective cohort study was performed in CS patients with an ICD implantation between 2010 and 2019. Primary outcome was appropriate ICD therapy. Independent predictors were calculated using Cox proportional hazard analysis. RESULTS: 105 patients were included. An ICD was implanted for primary prevention in 79%. During a median follow-up of 2.8 years, 34 patients (32.4%) received appropriate ICD therapy of whom 24 (22.9%) received an appropriate shock. Three patients (2.9%) received an inappropriate shock due to atrial fibrillation. Independent predictors of appropriate therapy included prior ventricular arrhythmias (hazard ratio [HR]: 10.5 [95% confidence interval (CI): 5.0-21.9]) and right ventricular late gadolinium enhancement (LGE) (HR: 3.6 [95% CI: 1.7-7.6]). Within the primary prevention group, right ventricular LGE (HR: 5.7 [95% CI: 1.6-20.7]) was the only independent predictor of appropriate therapy. Left ventricular ejection fraction did not differ between patients with and without appropriate therapy (44.4% vs. 45.6%, p = .70). CONCLUSION: In CS patients with an ICD, a high rate of appropriate therapy was observed and a low rate of inappropriate shocks. Prior ventricular arrhythmias and right ventricular LGE were independent predictors of appropriate therapy.

A randomized trial of non-fasting vs. fasting for cardiac implantable electronic device procedures (Fast-CIED Study).

AIMS: Data on safety and efficacy of a non-fasting strategy in minimal invasive cardiac procedures are lacking. We assessed a non-fasting strategy compared with a fasting strategy regarding patient's well-being and safety in elective cardiac implantable electronic device (CIED) procedures. METHODS AND RESULTS: In this randomized, single-blinded clinical trial, 201 patients (non-fasting = 100, fasting = 101) with a mean age of 72.0 ± 11.6 years (66.7% male) were assigned to a non-fasting strategy (solids/fluids allowed up to 1 h) or a fasting strategy (at least 6 h no solids and 2 h no fluids) before the procedure and analysed on an intention-to-treat basis. The co-primary outcomes were patients' well-being scores (based on numeric rating scale, 0-10) and incidence of intra-procedural food-related adverse events, including vomiting, perioperative pulmonary aspiration, and emergency intubation. Renal, haematological, and metabolic blood parameters and 30-day follow-up data were gathered. The summed pre-procedural patients' well-being score was significantly lower in the non-fasting group [non-fasting: 13.1 ± 9.6 vs. fasting: 16.5 ± 11.4, 95% confidence interval (CI) of mean difference (MD) -6.35 to -0.46, P = 0.029], which was mainly driven by significantly lower scores for hunger and tiredness in the non-fasting group (non-fasting vs. fasting; hunger: 0.9 ± 1.9 vs. 3.1 ± 3.2, 95% CI of MD -2.86 to -1.42, P < 0.001; tiredness: 1.6 ± 2.3 vs. 2.6 ± 2.7, 95% CI of MD -1.68 to -0.29, P = 0.023). No intra-procedural food-related adverse events were observed. Relevant blood parameters and 30-day follow-up did not show significant differences. CONCLUSION: These results showed that a non-fasting strategy is beneficial to a fasting one regarding patient's well-being and comparable in terms of safety for CIED procedures (NCT04389697).

Fragmented QRS is associated with ventricular arrhythmias in heart failure patients: A systematic review and meta-analysis.

INTRODUCTION: Many primary prevention heart failure (HF) patients with an implantable cardiac defibrillator (ICD) rarely experience life-threatening ventricular arrhythmias (VA). New strategies are required to identify patients most at risk of VA and sudden cardiac death who would benefit from an ICD. One potential method is the detection of fragmented QRS (fQRS) on the electrocardiogram. The aim was to assess the predictive capacity of fQRS for VA and mortality in ischemic (ICM) and non-ischemic cardiomyopathy (NICM) primary prevention HF patients. METHODS AND RESULTS: A systematic review and meta-analysis of studies examining fQRS in HF patients with or without an ICD who met primary prevention indications with reduced ejection fraction ≤40%. Outcome measures were VA (or appropriate ICD therapy) and all-cause mortality. Ten studies involving 3885 patients were included for analysis. Most patients were male with non-fQRS patients being significantly younger (-1.5[-2.66, -0.42], p = .03). Diabetes was more likely in fQRS patients (1.12[1.01, 1.25], p = .03) while non-fQRS patients were 28% more likely to have a history of atrial fibrillation (0.82[0.67,1.00], p = .05). Ventricular arrhythmias were significantly 1.5 times more likely in patients with fQRS (1.51[1.02, 2.25], p = .04). HF patients were 1.7 times more likely to die of any cause if fQRS was present (1.68[1.13, 2.52], p = .01). NICM patients with fQRS have a significant 2.6-fold increased incidence of death compared with ICM patients (2.55[1.63, 3.98], p < .0001). CONCLUSION: fQRS is associated with VA and all-cause mortality and may be a novel marker in the risk stratification of primary prevention HF patients indicated for ICD implantation.

Validation of CalECG software for primary prevention heart failure patients: Reducing inter-observer measurement variability.

BACKGROUND: In primary prevention heart failure patients the 12­lead electrocardiogram (ECG) may be useful for the prediction of ventricular arrhythmias. However, inter-observer measurement variability first needs to be identified and any software used, validated. OBJECTIVE: To compare manual ECG measures with CalECG software and to assess the reliability of visual recognition of fragmented QRS (fQRS) by advanced cardiology trainees. METHODS: 30 pre-implant ECGs were assessed on patients who met guidelines for primary prevention Implantable Cardiac Defibrillator. Parameters included RR, PR, QT, QRS duration, axis location, fQRS and T wave peak to T wave end (TpTe). ECGs were analyzed by members of the cardiology department with different levels of experience, and compared to CalECG software. Interobserver agreement was assessed using Fleiss' Kappa (κ) and intraclass correlation coefficients (ICC). Pearson correlation coefficient (r) was used to compare human and software measures. RESULTS: Strong/very strong correlation was recorded across manual ECG measures (ICC = 0.749-0.979, p ≤ 0.0001) with moderate/strong correlation for TpTe (ICC = 0.547-0.765, p ≤ 0.001). Advanced cardiology trainees demonstrated substantial agreement on ECG interpretation (κ = 0.788, p ≤ 0.0001), however, reliability of fQRS assessment was only moderate for identification (κ = 0.5, p ≤ 0.0001) and fair for location (κ = 0.295, p = 0.001). CalECG software showed strong/very strong correlation with manual measurement for standard measures (r = 0.756-0.977, p ≤ 0.001). Concordance between human and software TpTe measurements varied between leads, with V5 showing a non-significant weak correlation (r = 0.197). CONCLUSION: CalECG software showed strong/very strong correlation with standard manual measures which affirms its use in ECG analysis. Advanced cardiology trainees showed greater variability in the identification and location of fQRS.

The value of C-reactive protein-to-albumin ratio in predicting long-term mortality among HFrEF patients with implantable cardiac defibrillators.

BACKGROUND: Patients with heart failure with reduced ejection fraction (HFrEF) who received implantable cardiac defibrillator (ICD) still remain at high risk due to pump failure and prevalent comorbid conditions. The primary aim of this research was to evaluate the predictive value of C-reactive protein-to-albumin ratio (CAR) for all-cause mortality among patients with HFrEF despite ICD implantation. MATERIALS AND METHODS: Those who were implanted ICD for HFrEF in our institution between 2009 and 2019 were included. Data were extracted from hospital's database. CAR was calculated as ratio of C-reactive protein (CRP) to serum albumin concentration. Patients were grouped into tertiles in accordance with CAR at the time of the implantation. During follow-up duration of 38 [17-77] months, survival times of tertiles were compared by using Kaplan-Meier survival method. Forward Cox proportional regression model was used for multivariable analysis. RESULTS: Thousand and eleven patients constituted the study population. Ischaemic cardiomyopathy was the primary diagnosis in 92.3%, and ICD was implanted for the primary prevention among 33.9% of patients. Of those, 14.5% died after the discharge. Patients in tertile 3 (T3) had higher risk of mortality (4.2% vs 11.0% vs 28.5%) compared with those in other tertiles. Multivariable analysis revealed that when patients in T1 were considered as the reference, both those in T2 and those in T3 had independently higher risk of all-cause mortality. This finding was consistent in the unadjusted and adjusted multivariable models. CONCLUSION: Among patients with HFrEF and ICD, elevated CAR increased the risk of all-cause mortality at long term.

Reduction in new cardiac electronic device implantations in Catalonia during COVID-19.

AIMS: During the COVID-19 pandemic, concern regarding its effect on the management of non-communicable diseases has been raised. However, there are no data on the impact on cardiac implantable electronic devices (CIED) implantation rates. We aimed to determine the impact of SARS-CoV2 on the monthly incidence rates and type of pacemaker (PM) and implantable cardiac defibrillator (ICD) implantations in Catalonia before and after the declaration of the state of alarm in Spain on 14 March 2020. METHODS AND RESULTS: Data on new CIED implantations for 2017-20 were prospectively collected by nine hospitals in Catalonia. A mixed model with random intercepts corrected for time was used to estimate the change in monthly CIED implantations. Compared to the pre-COVID-19 period, an absolute decrease of 56.5% was observed (54.7% in PM and 63.7% in ICD) in CIED implantation rates. Total CIED implantations for 2017-19 and January and February 2020 was 250/month (>195 PM and >55 ICD), decreasing to 207 (161 PM and 46 ICD) in March and 131 (108 PM and 23 ICD) in April 2020. In April 2020, there was a significant fall of 185.25 CIED implantations compared to 2018 [95% confidence interval (CI) 129.6-240.9; P < 0.001] and of 188 CIED compared to 2019 (95% CI 132.3-243.7; P < 0.001). No significant differences in the type of PM or ICD were observed, nor in the indication for primary or secondary prevention. CONCLUSIONS: During the first wave of the COVID-19 pandemic, a substantial decrease in CIED implantations was observed in Catalonia. Our findings call for measures to avoid long-term social impact.

Impact of delayed device re-implantation on outcomes of patients with cardiovascular implantable electronic device related infective endocarditis.

BACKGROUND: Optimal timing of cardiovascular implantable electronic device (CIED) re-implantation following device removal due to infection is undefined. Multinational guidelines reflect this and include no specific recommendation for this timing, while others have recommended waiting at least 14 days in cases of CIED related infective endocarditis (CIED-IE). The current work seeks to clarify this issue. METHODS: We retrospectively reviewed institutional data at Mayo Clinic, Minnesota of patients aged ≥ 18 years who developed CIED-IE from January 1, 1991 to February 1, 2016. CIED-IE was defined as echocardiogram reported device lead or valvular vegetation. Regression analyses were used to relate the risk of clinical outcomes to the interval between CIED removal and re-implantation and the location of vegetations. RESULTS: A total of 109 patients met study inclusion criteria. A majority (68.8%) of patients were men and the median age was 68.0 years. Transoesophageal echocardiogram (TEE) was performed in 95.4% of patients, with valve vegetations detected in 33.9% (n = 37). Survival analysis comparing patients in whom device re-implantation was < 14 days vs. ≥14 days, and further categorized by those with and without valve vegetation, showed a significant difference (P = 0.028); patients with valve vegetation and reimplantation interval < 14 days had the lowest (58.7%) 12-month survival. When adjusted for valve vegetation, longer time interval for reimplantation trended toward increased hospital length of stay (P = 0.079). CONCLUSION: Our findings suggest that the recommended 14-day delay between CIED extraction and re-implantation in CIED-IE patients is associated with a survival benefit, but longer length of hospital stay following re-implantation.

Risk stratification in cardiomyopathies (dilated, hypertrophic, and arrhythmogenic cardiomyopathy) by cardiac magnetic resonance imaging.

Cardiac magnetic resonance imaging (CMR) is a non-invasive, multiplanar, and high spatial resolution imaging technique, which represents the current gold standard for the evaluation of biventricular volumes and function. Furthermore, unlike other methods, it has the great advantage of characterizing the myocardial tissue by identifying the presence of alterations, such as oedema and focal and diffuse fibrosis. In particular, the late gadolinium enhancement technique makes it possible to identify areas of focal fibrosis that often constitute the substrate for the triggering of threatening ventricular arrhythmias at the basis of sudden cardiac death. For this reason, the use of CMR in the study of cardiomyopathies has become of primary importance, both for the differential diagnosis and for patient risk stratification. In this brief review, the ability of CMR in prognostic stratification of patients with dilated, hypertrophic, and arrhythmogenic cardiomyopathy will be analysed. In particular, the role of CMR in the prediction of arrhythmic risk and in the decision-making process for the implantation of a cardiac defibrillator will be examined.

Remote Device Interrogation Kiosks (ReDInK) - Pharmacy Kiosk Remote Testing of Pacemakers and Implantable Cardioverter-Defibrillators for Rural Victorians. A Novel Strategy to Tackle COVID-19.

BACKGROUND: In the era of COVID-19, travel restrictions and social distancing measures have changed the landscape for device interrogations of pacemakers and defibrillators for rural Victorians. Previously, device checks were performed infrequently in large volume, face-to-face rural clinics by visiting cardiologists and technicians. Access to remote areas and social distancing restrictions have made these clinics unfeasible to operate. The Cardiac Society of Australia and New Zealand (CSANZ) and Heart Rhythm Society (HRS) COVID-19 consensus statements have suggested the utilisation of remote monitoring to minimise the potential spread of COVID-19 infections between clinicians and high-risk patients. A novel solution to this challenge was the implementation of a remote device interrogation (RI) service located in two kiosks at two rural pharmacies. This service was termed Remote Device Interrogation Kiosks (ReDInK). AIM: This cross-sectional observational study aimed to describe the set-up process, safety and efficacy of RI and customer satisfaction of the ReDInK program. METHODS: Two-hundred-and-ninety-two (292) rurally located patients with implantable cardiac devices were identified via the cardiology department database. Of these, 101 (44%) were enrolled into the ReDInK program across two rurally located pharmacies between April and July 2020. RI was performed and download outcomes were reviewed. A customer satisfaction survey assessed attitudes towards the program and explored options of ongoing service application. RESULTS: Of 101 patients enrolled into ReDInK, 96 (95%) resulted in satisfactory device checks. Four (4) individuals failed-to-attend and one individual experienced technical download issues. Of the 96 satisfactory device checks, three required in-person follow-up for reasons including battery replacement, lead repositioning and in-person programming. No adverse events were reported. A satisfaction telephone survey was conducted with 81 (83%) participants enrolled in ReDInK. Seventy-one (71) individuals (88%) of those surveyed expressed satisfaction and 73 (90%) labelled the process as efficiently conducted. Sixty-nine (69) (85%) participants felt reassured that this service was established during the pandemic. However 47 (58%) participants reported they would still feel comfortable to undergo in-person reviews despite social distancing recommendations. CONCLUSIONS: With the COVID-19 pandemic posing restrictions to social distancing and reducing unnecessary in-person interaction, the ReDInK program emerges as an efficacious and safe solution for patients in rural Victoria. The program's widely positive reception and successful conduction in rural Victoria invites further opportunity for a wider application of similar programs, expanding its role to metropolitan areas.

Safety of bioelectrical impedance analysis in advanced heart failure patients.

BACKGROUND: Cardiac cachexia and frailty are major complications of advanced heart failure (AHF). Bioelectrical impedance analysis (BIA) may provide valuable information regarding fluid balance, muscle mass and prognosis. The main concerns regarding the use of BIA in AHF patients remain arrhythmias and electromagnetic interferences with cardiac implantable electronic devices (CIEDs). Reliable data regarding patients on continuous-flow ventricular assist device (cf-VAD) remain scarce. The aim of this study is to evaluate the safety of BIA in AHF patients on pro-arrhythmogenic therapy with an implanted CIED and/or with a cf-VAD. METHODS: We prospectively performed 217 BIA measurements in 143 AHF patients at risk of severe arrhythmias due to inotropic support/a history of ventricular arrhythmias and/or treated with CIED, including 104 patients with an ICD, CRT or pacemaker and 95 patients with a cf-VAD. All patients were under continuous Electrocardiogram (ECG) monitoring and clinical surveillance for 24 hours. RESULTS: No adverse events were observed during the 217 BIA measurements: No rhythm disturbances were documented in the telemetric monitoring during or within 30 minutes after the measurement. CIEDs showed no malfunction, regardless of the location measured or the device manufacturer. In particular, no inappropriate shocks were observed. No alarms, flow disturbances, or malfunctions of the cf-VAD occurred during or after the measurements. CONCLUSION: We consider BIA a safe measurement with major clinical relevance in our cohort of AHF patients, despite an increased arrhythmic potential on inotropic support or the presence of implanted electronic devices (ICD, CRT, pacemaker and cf-VAD).

Phantom Model Testing of Active Implantable Cardiac Devices at 50/60 Hz Electric Field.

Exposure to external extremely low-frequency (ELF) electric and magnetic fields induces the development of electric fields inside the human body, with their nature depending on multiple factors including the human body characteristics and frequency, amplitude, and wave shape of the field. The objective of this study was to determine whether active implanted cardiac devices may be perturbed by a 50 or 60 Hz electric field and at which level. A numerical method was used to design the experimental setup. Several configurations including disadvantageous scenarios, 11 implantable cardioverter-defibrillators, and 43 cardiac pacemakers were tested in vitro by an experimental bench test up to 100 kV/m at 50 Hz and 83 kV/m at 60 Hz. No failure was observed for ICNIRP public exposure levels for most configurations (in more than 99% of the clinical cases), except for six pacemakers tested in unipolar mode with maximum sensitivity and atrial sensing. The implants configured with a nominal sensitivity in the bipolar mode were found to be resistant to electric fields exceeding the low action levels, even for the highest action levels, as defined by the Directive 2013/35/EU. Bioelectromagnetics. 2020;41:136-147. © 2020 Bioelectromagnetics Society.

Safety and efficiency of a common and simplified protocol for pacemaker and defibrillator surveillance based on remote monitoring only: a long-term randomized trial (RM-ALONE).

AIMS: This trial aimed to evaluate the safety and efficiency of a common and simplified protocol for the surveillance of cardiac implantable electronic devices based on remote monitoring (RM) in patients with pacemakers (PMs) and implantable cardiac defibrillators (ICDs) for at least 24 months. METHODS AND RESULTS: The RM-ALONE is a multicentre prospective trial that randomly assigned 445 patients in two groups, both followed by RM: the home monitoring-only (HMo) based on RM + remote interrogations (RIs) every 6 months and the HM + IO that adds in-office evaluations every 6 months to RM. Four hundred and forty-five patients were enrolled in the study, 294 PMs and 151 ICDs recipients. In the HMo group, 20% of patients experienced ≥1 major adverse cardiac event (MACE) vs. 19.5% in HM + IO group (P = 0.006 for non-inferiority). The proportion of patients with a PM/ICD who experienced ≥1 MACE was 15.2/29.3% in HMo group and 16.1/26.3% in HM + IO group (hazard ratio 0.95/1.15, 95% confidence interval 0.53-1.70/0.62-2.10). There were 789 in-office evaluations (136 in the HMo and 653 in the HM + IO; P < 0.001). There was a 79.2% reduction of in-office evaluations with no significant differences in unscheduled visits between groups: 122 (54.5%) in HMo and 101 (45.3%) in HM + IO; P = 0.15. The time a physician/nurse spent per patient/follow-up was significantly reduced in the HMo group: 4/5 min (0-30)/(1-30) vs. 10/10 min (0-40)/(1-40) in HM + IO (P < 0.0001). CONCLUSION: The RM-ALONE protocol common for ICD and PM surveillance, consisting of RM + RI every 6 months has proven safe and efficient in reducing hospital visits and staff workload.

Postmortem interrogation of cardiac implantable electrical devices may clarify time and cause of death.

BACKGROUND: Postmortem interrogation of cardiac implantable electrical devices (CIED) in autopsy is not routinely performed. Thus, it remains unclear whether an interrogation might clarify time and cause of death. METHODS: Seventy of 4401 patients (1.6%) undergoing autopsy in 2014 and 2015 presented with a CIED. The explanted CIED were interrogated with respect to time and possible cause of death. Battery and lead parameters, clinical and technical alerts, and arrhythmia episodes were reviewed and afterwards correlated with the results of autopsy and clinical data. RESULTS: Twenty-five implantable cardioverter defibrillators (ICD) and 45 pacemaker (PM) devices were analyzed. Death was classified as cardiac by autopsy in 17 of 70 patients. Accordingly, presumably lethal ventricular arrhythmias were documented in six patients (8.6%; 5 ICD, 1 PM). In two of 30 patients with unknown cause of death after autopsy (6.7%), interrogation revealed ventricular tachycardia as potential reason for decease (1 ICD, 1 PM). Postmortem CIED interrogation additionally allowed to make a statement regarding the day of death in 36 patients (51%; 13 ICD, 23 PM). This was in accordance with clinical data or the results of autopsy in nine patients (25%; 3 ICD, 6 PM) or could even clarify the time of death in six patients (16.7%; 4 ICD, 2 PM). CONCLUSION: Interrogation of CIED revealed potentially lethal ventricular arrhythmias in 9 of 70 patients investigated and enabled valid estimation of the day of death in 15 patients. We therefore conclude that routinely performed postmortem CIED interrogation may clarify time and cause of death.

Sudden cardiac death: an update.

Sudden cardiac death (SCD) is a devastating and all too common result of both acquired and genetic heart diseases. The profound sadness endured by families is compounded by the risk many of these deaths confer upon surviving relatives. For those with known cardiac disease, disease-specific therapy and risk stratification are key to reducing sudden death. For families of a SCD victim, uncovering a definitive cause of death can help relieve the agonising uncertainty and is a vital first step in screening surviving relatives and instituting therapy to reduce SCD risk. Increasing knowledge about the molecular mechanisms and genetic drivers of malignant arrhythmias in the diverse clinical entities that can cause SCD is vital if we are to optimise risk stratification and personalise patient care. Advances in diagnostic tools, disease-specific therapy and defibrillator technology are improving outcomes for patients and their families but there is still much progress to be made.