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Background and Objective: Implantable Cardioverter Defibrillator (ICD) insertion is a common therapeutic method for patients at risk of sudden cardiac death due to ventricular arrhythmias. The present research aimed to identify predictive factors for mortality in patients undergoing ICD implantation. Materials and Methods: In this mix-cohort study, 225 patients undergoing ICD placement were enrolled through a census from March 2017 to March 2021 at Farshchian Heart Center in Hamadan, Iran. The patients' demographic characteristics and blood tests were collected by accessing their electronic records and conducting telephone interviews. Participants were followed up to investigate the factors that influence the death. The Cox regression model was performed using Stata software (version 14) to identify predictive factors for premature mortality. Results: The survey results from the study of 225 individuals indicated that 183 people (80.88%) were male, 91 people (40.44%) were in the age group of 55-65 years, and 87 people (34.66%) were in the age group above 65 years. Moreover, 25 cases (11.1%) of death occurred, with 1, 2, 3, and 4-year survival rates of 96.3%, 93%, 83.2%, and 83.2%, respectively. Additionally, being older than 65 years (hazard ratio [HR] 5.84, CI: 1.20, 21.89) was associated with an increased risk of mortality, while ejection fraction greater than 15% (HR 0.22, CI: 0.06, 0.76) was associated with a decreased risk of mortality following ICD implantation. Conclusion: In this study, being older than 65 years and an ejection fraction of less than 15% were associated with an increased risk of mortality following ICD implantation. Given the negative outcomes, the follow-up of these patients should be conducted with greater precision.

Introduction: Patients with hypertrophic cardiomyopathy (HCM) are at risk for lethal ventricular arrhythmia, but the electrophysiological substrate behind this is not well-understood. We used non-invasive electrocardiographic imaging to characterize patients with HCM, including cardiac arrest survivors. Methods: HCM patients surviving ventricular fibrillation or hemodynamically unstable ventricular tachycardia (n = 17) were compared to HCM patients without a personal history of potentially lethal arrhythmia (n = 20) and a pooled control group with structurally normal hearts. Subjects underwent exercise testing by non-invasive electrocardiographic imaging to estimate epicardial electrophysiology. Results: Visual inspection of reconstructed epicardial HCM maps revealed isolated patches of late activation time (AT), prolonged activation-recovery intervals (ARIs), as well as reversal of apico-basal trends in T-wave inversion and ARI compared to controls (p < 0.005 for all). AT and ARI were compared between groups. The pooled HCM group had longer mean AT (60.1 ms vs. 52.2 ms, p < 0.001), activation dispersion (55.2 ms vs. 48.6 ms, p = 0.026), and mean ARI (227 ms vs. 217 ms, p = 0.016) than structurally normal heart controls. HCM ventricular arrhythmia survivors could be differentiated from HCM patients without a personal history of life-threatening arrhythmia by longer mean AT (63.2 ms vs. 57.4 ms, p = 0.007), steeper activation gradients (0.45 ms/mm vs. 0.36 ms/mm, p = 0.011), and longer mean ARI (234.0 ms vs. 221.4 ms, p = 0.026). A logistic regression model including whole heart mean activation time and activation recovery interval could identify ventricular arrhythmia survivors from the HCM cohort, producing a C statistic of 0.76 (95% confidence interval 0.72-0.81), with an optimal sensitivity of 78.6% and a specificity of 79.8%. Discussion: The HCM epicardial electrotype is characterized by delayed, dispersed conduction and prolonged, dispersed activation-recovery intervals. Combination of electrophysiologic measures with logistic regression can improve differentiation over single variables. Future studies could test such models prospectively for risk stratification of sudden death due to HCM. [ABSTRACT FROM AUTHOR]

Background Purpose Methods Results Conclusions The programing of subcutaneous implantable cardioverter‐defibrillators (S‐ICD) in clinical practice has been little studied, as the activation status of the SMART Pass filter, which was implemented to reduce inappropriate shocks.We assessed device programing during follow‐up and the rate of detected arrhythmias in consecutive S‐ICD recipients.We analyzed data from 670 S‐ICD patients followed on the remote network at 17 Italian centers for a median of 31 months (25th–75th percentile: 16–51). The enhanced SMART Pass version, introduced in October 2022, was expected to reduce the unintentional deactivation rate.At the latest remote data transmission, the median conditional zone cut‐off was set to 210 bpm (25th–75th percentile: 200–220), the shock zone cutoff was 250 bpm (25th–75th percentile: 240–250), and the SMART Pass was enabled in 586 (87%) patients. During follow‐up, 194 automatic deactivation events were reported in 118 (18%) patients. Shocks were delivered in 129 (19%) patients, and untreated arrhythmias were recorded in 136 (20%) patients. The rate of shocks was lower when SMART Pass was enabled ‐0.12/patient‐year (95% CI: 0.10–0.14) versus 0.20 (95% CI: 0.15–0.26) (p = .002), as it was the rate of untreated arrhythmias ‐0.12/patient‐year (95% CI: 0.11–0.14) versus 0.23 (95% CI: 0.18–0.30) (p = .001). The enhanced SMART Pass version was associated with a lower rate of deactivations ‐0.04/patient‐year (95% CI: 0.02–0.05) versus 0.14 (95% CI: 0.12–0.16) (p < .001), and with a reduction in treated and untreated arrhythmias (Incidence rate ratios: 0.40 (95% CI: 0.28–0.53) and 0.40 (95% CI: 0.30–0.55), respectively (p < .001)).Centers tend to program devices to detect high ventricular rates for arrhythmia detection, to minimize inappropriate shock occurrences. SMART Pass activation is associated with lower rates of detected and treated arrhythmias. The enhanced SMART Pass version seems associated with a lower deactivation rate and with a further decrease in treated arrhythmias. [ABSTRACT FROM AUTHOR]

Introduction: Long QT syndrome (LQTS) is an autosomal dominant inherited cardiac condition characterized by a QT interval prolongation and risk of sudden death. There are 17 subtypes of this syndrome associated with genetic variants in 11 genes. The second most common is type 2, caused by a mutation in the KCNH2 gene, which is part of the potassium channel and influences the final repolarization of the ventricular action potential. This case report presents an Ecuadorian teen with congenital Long QT Syndrome type 2 (OMIM ID: 613688), from a family without cardiac diseases or sudden cardiac death backgrounds. Case presentation: A 14-year-old girl with syncope, normal echocardiogram, and an irregular electrocardiogram was diagnosedwith LQTS. Moreover, by performingNext-Generation Sequencing, a pathogenic variant in theKCNH2 gene p.(Ala614Val) (ClinVar ID: VCV000029777.14) associated with LQTS type 2, and two variants of uncertain significance in the AKAP9 p.(Arg1654GlyfsTer23) (rs779447911), and TTN p. (Arg34653Cys) (ClinVar ID: VCV001475968.4) genes were identified. Furthermore, ancestry analysis showed a mainly Native American proportion. Conclusion: Based on the genomic results, the patient was identified to have a high-risk profile, and an implantable cardioverter defibrillator was selected as the best treatment option, highlighting the importance of including both the clinical and genomics aspects for an integral diagnosis. [ABSTRACT FROM AUTHOR]

IntroductionLong QT syndrome (LQTS) is an autosomal dominant inherited cardiac condition characterized by a QT interval prolongation and risk of sudden death. There are 17 subtypes of this syndrome associated with genetic variants in 11 genes. The second most common is type 2, caused by a mutation in the KCNH2 gene, which is part of the potassium channel and influences the final repolarization of the ventricular action potential. This case report presents an Ecuadorian teen with congenital Long QT Syndrome type 2 (OMIM ID: 613688), from a family without cardiac diseases or sudden cardiac death backgrounds.Case presentationA 14-year-old girl with syncope, normal echocardiogram, and an irregular electrocardiogram was diagnosed with LQTS. Moreover, by performing Next-Generation Sequencing, a pathogenic variant in the KCNH2 gene p.(Ala614Val) (ClinVar ID: VCV000029777.14) associated with LQTS type 2, and two variants of uncertain significance in the AKAP9 p.(Arg1654GlyfsTer23) (rs779447911), and TTN p. (Arg34653Cys) (ClinVar ID: VCV001475968.4) genes were identified. Furthermore, ancestry analysis showed a mainly Native American proportion.ConclusionBased on the genomic results, the patient was identified to have a high-risk profile, and an implantable cardioverter defibrillator was selected as the best treatment option, highlighting the importance of including both the clinical and genomics aspects for an integral diagnosis.

In 2022 and 2023, Medtronic recalled implantable defibrillators because they may deliver less than full-energy shocks. The 2022 problem truncates the second phase of the waveform (SCP-T2), resulting in ∼32-J shocks, and is mitigated by downloadable software. The 2023 malfunction truncates the first phase of the waveform, resulting in 0- to 12-J shocks due to a glassed feedthrough problem (GFT-T1) that might be avoided by programming B>AX shock polarity. The purpose of this study was to assess the consequences of GFT-T1 and SCP-T2 shocks in the Food and Drug Administration's Manufacturers and User Facility Device Experience (MAUDE) database and to estimate the incidences of GFT-T1 and SCP-T2. We analyzed MAUDE reports supplemented by Medtronic data; lead failures were excluded. The incidences of SCP-T2 and GFT-T1 were estimated using USA volumes for devices with glassed feedthroughs. One hundred thirty-two devices delivered truncated shocks: 27 (20.5%) were GFT-T1; 103 (78.0%) were SCP-T2; and 2 (1.5%) truncated both phases (BOTH-T1&2). Of 54 ventricular fibrillation (VF) patients, 21 (38.9%) were not defibrillated by truncated shocks: 8 (38.1%) received GFT-T1 shocks, 12 (57.1%) received SCP-T2 shocks, and 1 received a BOTH-T1&2 shock; 2 patients suffered unrelated deaths; 1 was externally rescued; 1 outcome was unknown; the others were defibrillated by subsequent shocks or terminated spontaneously. The majority of patients (79.1%) shocked for ventricular tachycardia (VT) were converted, primarily (94.1%) by SCP-T2 shocks. Estimated incidences of GFT-T1 and SCP-T2 were 0.0078%–0.0088% and 0.1062%–0.1110%. GFT-T1 and SCP-T2 shocks can result in failure to terminate VF/VT, but they may be preventable. Although the incidences of these truncated shocks are very low, heightened surveillance is warranted. [ABSTRACT FROM AUTHOR]

Aims Electrophysiological (EP) operations that have traditionally involved long hospital lengths of stay (LOS) are now being undertaken as day case procedures. The coronavirus disease-19 pandemic served as an impetus for many centres to shorten LOS for EP procedures. This survey explores LOS for elective EP procedures in the modern era. Methods and results An online survey consisting of 27 multiple-choice questions was completed by 245 respondents from 35 countries. With respect to de novo cardiac implantable electronic device (CIED) implantations, day case procedures were reported for 79.5% of implantable loop recorders, 13.3% of pacemakers (PMs), 10.4% of implantable cardioverter defibrillators (ICDs), and 10.2% of cardiac resynchronization therapy (CRT) devices. With respect to CIED generator replacements, day case procedures were reported for 61.7% of PMs, 49.2% of ICDs, and 48.2% of CRT devices. With regard to ablations, day case procedures were reported for 5.7% of atrial fibrillation (AF) ablations, 10.7% of left-sided ablations, and 17.5% of right-sided ablations. A LOS ≥ 2 days for CIED implantation was reported for 47.7% of PM, 54.5% of ICDs, and 56.9% of CRT devices and for 54.5% of AF ablations, 42.2% of right-sided ablations, and 46.1% of left-sided ablations. Reimbursement (43–56%) and bed availability (20–47%) were reported to have no consistent impact on the organization of elective procedures. Conclusion There is a wide variation in the LOS for elective EP procedures. The LOS for some procedures appears disproportionate to their complexity. Neither reimbursement nor bed availability consistently influenced LOS. [ABSTRACT FROM AUTHOR]

The Implantable Cardioverter-Defibrillator (ICD) is a well-established life-saving therapy for heart failure patients, but due to the risk for unnecessary shocks, deactivation of ICD:s is recommended at the end of life. We aimed to identify i) how many people with HF and an ICD who died in Sweden in 2018 received Specialized Palliative Care (SPC), ii) of those dying outside of hospital, the proportion with deactivated ICDs prior to death for the group as a whole and by SPC access. We analyzed data from i) the Swedish ICD and Pacemaker Registry to find all who died with an ICD in Sweden in 2018, ii) the Swedish Register of Palliative Care and, iii) the Swedish Causes of Death Certificate Register to find those who died outside of hospital. Clinical records were obtained to assess if ICDs were deactivated before death. Descriptive statistics, t -tests and chi-squared tests were applied. 46/406 (11%) of those who died with an ICD in Sweden in 2018 had SPC access, of whom 50% also had cancer. 86/164 (52%) ICDs were deactivated prior to death in people dying outside of hospital; higher in those accessing SPC (36/46, (78%) SPC access versus 151/360, (42%) no SPC access; p < 0.05). Half of those with HF and an ICD dying outside of hospital had ICD deactivation prior to death. Those accessing SPC were more likely to have their ICD deactivated but few received SPC, without a comorbid cancer diagnosis. • This is a nationwide, register based study of all who died with heart failure and an ICD in Sweden in 2018. • A study of ICD-deactivation in patients dying outside of hospital and the impact of Specialized Palliative Care (SPC). • Half of those with HF and an ICD dying outside of hospital had ICD deactivation prior to death. • Those in SPC were more likely to have their ICD deactivated but few received SPC, without a comorbid cancer diagnosis. [ABSTRACT FROM AUTHOR]

Aims Patients with cardiomyopathies and channelopathies are usually younger and have a predominantly arrhythmia-related prognosis; they have nearly normal life expectancy thanks to the protection against sudden cardiac death provided by the implantable cardioverter defibrillator (ICD). The subcutaneous ICD (S-ICD) is an effective alternative to the transvenous ICD and has evolved over the years. This study aimed to evaluate the rate of inappropriate shocks (IS), appropriate therapies, and device-related complications in patients with cardiomyopathies and channelopathies who underwent modern S-ICD implantation. Methods and results We enrolled consecutive patients with cardiomyopathies and channelopathies who had undergone implantation of a modern S-ICD from January 2016 to December 2020 and who were followed up until December 2022. A total of 1338 S-ICD implantations were performed within the observation period. Of these patients, 628 had cardiomyopathies or channelopathies. The rate of IS at 12 months was 4.6% [95% confidence interval (CI): 2.8–6.9] in patients with cardiomyopathies and 1.1% (95% CI: 0.1–3.8) in patients with channelopathies (P = 0.032). No significant differences were noted over a median follow-up of 43 months [hazard ratio (HR): 0.76; 95% CI: 0.45–1.31; P = 0.351]. The rate of appropriate shocks at 12 months was 2.3% (95% CI: 1.1–4.1) in patients with cardiomyopathies and 2.1% (95% CI: 0.6–5.3) in patients with channelopathies (P = 1.0). The rate of device-related complications was 0.9% (95% CI: 0.3–2.3) and 3.2% (95% CI: 1.2–6.8), respectively (P = 0.074). No significant differences were noted over the entire follow-up. The need for pacing was low, occurring in 0.8% of patients. Conclusion Modern S-ICDs may be a valuable alternative to transvenous ICDs in patients with cardiomyopathies and channelopathies. Our findings suggest that modern S-ICD therapy carries a low rate of IS. Clinical Trial Registration URL: http://clinicaltrials.gov/ Identifier: NCT02275637. [ABSTRACT FROM AUTHOR]

Aims: Cardiac device–related infective endocarditis (CDRIE) is a severe complication of cardiac device (CD) implantation and is usually treated by antibiotic therapy and percutaneous device extraction. Few studies report the management and prognosis of CDRIE in real life. In particular, the rate of device extraction in clinical practice and the management of patients with left heart infective endocarditis (LHIE) and an apparently non-infected CD (LHIE+CDRIE−) are not well described. Methods and results: We sought to study in EURO-ENDO, the characteristics, prognosis, and management of 483 patients with a CD included in the European Society of Cardiology EurObservational Research Programme EURO-ENDO registry. Three populations were compared: 280 isolated CDRIE (66.7 ± 14.3 years), 157 patients with LHIE and an apparently non-infected CD (LHIE+CDRIE−) (71.1 ± 13.6), and 46 patients with both LHIE and CDRIE (LHIE+CDRIE+) (70.2 ± 10.1). Echocardiography was not always transoesophageal echography (TOE); it was transthoracic echography (TTE) for isolated CDRIE in 88.4% (TOE = 67.6%), for LHIE+CDRIE− TTE = 93.0% (TOE = 58.6%), and for CDRIE+LHIE+ TTE = 87.0% (TOE = 63.0%). Nuclear imaging was performed in 135 patients (positive for 75.6%). In-hospital mortality was lower in isolated CDRIE 13.2% vs. 22.3% and 30.4% for LHIE+CDRIE− and LHIE+CDRIE+ (P = 0004). Device extraction was performed in 62.1% patients with isolated CDRIE, 10.2% of LHIE+CDRIE− patients, and 45.7% of CDRIE+LHIE+ patients. Device extraction was associated with a better prognosis [hazard ratio 0.59 (0.40–0.87), P = 0.0068] even in the LHIE+CDRIE− group (P = 0.047). Conclusion: Prognosis of endocarditis in patients with a CD remains poor, particularly in the presence of an associated LHIE. Although recommended by guidelines, device extraction is not always performed. Device removal was associated with better prognosis, even in the LHIE+CDRIE− group. Infective endocarditis associated with the presence of a cardiac device remains a serious disease and should be treated with device extraction, even in patients with left heart infective endocarditis and an apparently non-infected device. Graphical abstract [ABSTRACT FROM AUTHOR]

Background Transcutaneous electrical nerve stimulation (TENS) is an established method for pain relief. But electrical TENS currents are also a source of electromagnetic interference (EMI). Thus, TENS is considered to be contraindicated in implantable cardioverter-defibrillator (ICD) patients. However, data might be outdated due to considerable advances in ICD and cardiac resynchronization therapy (CRT) filtering and noise protection algorithm technologies. The aim of this pilot safety study was to re-evaluate the safety of TENS in patients with modern ICDs. Methods and results One hundred and seven patients equipped with 55 different models of ICD/CRT with defibrillators from 4 manufacturers underwent a standardized test protocol including TENS at the cervical spine and the thorax, at 2 stimulation modes—high-frequency TENS (80 Hz) and burst-mode TENS (2 Hz). Potential interference monitoring included continuous documentation of ECG Lead II, intracardiac electrograms and the marker channel. Electromagnetic interference was detected in 17 of 107 patients (15.9%). Most frequent were: interpretations as a premature ventricular beats (VS/S) in 15 patients (14%), noise reversion in 5 (4.6%) which resulted in temporary asynchronous pacing in 3 (2.8%), interpretation as ventricular tachycardia/ventricular fibrillation in 2 (1.9%), and premature atrial beat in 2 (1.9%) patients. Electromagnetic interference occurrence was influenced by position (chest, P < 0.01), higher current intensity (P < 0.01), and manufacturer (P = 0.012). Conclusion Overall, only intermittent and minor EMI were detected. Prior to the use of TENS in patients with ICDs, they should undergo testing under the supervision of a cardiac device specialist. [ABSTRACT FROM AUTHOR]

Aims Subcutaneous implantable cardioverter–defibrillator (S-ICD) therapy is expanding rapidly. However, there are few data on the S-ICD extraction procedure and subsequent patient management. The aim of this analysis was to describe the procedure, management, and outcome of S-ICD extractions in clinical practice. Methods and results We enrolled consecutive patients who required complete S-ICD extraction at 66 Italian centres. From 2013 to 2022, 2718 patients undergoing de novo implantation of an S-ICD were enrolled. Of these, 71 required complete S-ICD system extraction (17 owing to infection). The S-ICD system was successfully extracted in all patients, and no complications were reported; the median procedure duration was 40 (25th–75th percentile: 20–55) min. Simple manual traction was sufficient to remove the lead in 59 (84%) patients, in whom lead-dwelling time was shorter [20 (9–32) months vs. 30 (22–41) months; P = 0.032]. Hospitalization time was short in the case of both non-infectious [2 (1–2) days] and infectious indications [3 (1–6) days]. In the case of infection, no patients required post-extraction intravenous antibiotics, the median duration of any antibiotic therapy was 10 (10–14) days, and the re-implantation was performed during the same procedure in 29% of cases. No complications arose over a median of 21 months. Conclusion The S-ICD extraction was safe and easy to perform, with no complications. Simple traction of the lead was successful in most patients, but specific tools could be needed for systems implanted for a longer time. The peri- and post-procedural management of S-ICD extraction was free from complications and not burdensome for patients and healthcare system. Clinical Trial Registration URL: http://clinicaltrials.gov/ Identifier: NCT02275637. [ABSTRACT FROM AUTHOR]

A 72-year-old male with severe dilated cardiomyopathy, benefited of implantable cardiac defibrillator implementation. Device control shows high impedance. On X-ray, electrodes were completely twisted in the generator pocket, they were replaced and the generator was fixed to pectoralis-major fascia. Nurses report patient abnormal movements, scratching implantation area. This was identified as probably the trigger of the complication.

Aims In subcutaneous implantable cardioverter defibrillator (S-ICD) recipients, the UNTOUCHED study demonstrated a very low inappropriate shock rate on programming a conditional zone between 200 and 250 bpm and a shock zone for arrhythmias >250 bpm. The extent to which this programming approach is adopted in clinical practice is still unknown, as is its impact on the rates of inappropriate and appropriate therapies. Methods and results We assessed ICD programming on implantation and during follow-up in a cohort of 1468 consecutive S-ICD recipients in 56 Italian centres. We also measured the occurrence of inappropriate and appropriate shocks during follow-up. On implantation, the median programmed conditional zone cut-off was set to 200 bpm (IQR: 200–220) and the shock zone cut-off was 230 bpm (IQR: 210–250). During follow-up, the conditional zone cut-off rate was not significantly changed, while the shock zone cut-off was changed in 622 (42%) patients and the median value increased to 250 bpm (IQR: 230–250) (P < 0.001). UNTOUCHED-like programming of detection cut-offs was adopted in 426 (29%) patients immediately after device implantation, and in 714 (49%, P < 0.001) at the last follow-up. UNTOUCHED-like programming was independently associated with fewer inappropriate shocks (hazard ratio 0.50, 95%CI 0.25–0.98, P = 0.044), and had no impact on appropriate and ineffective shocks. Conclusions In recent years, S-ICD implanting centres have increasingly programmed high arrhythmia detection cut-off rates, at the time of implantation in the case of new S-ICD recipients, and during follow-up in the case of pre-existing implants. This has contributed significantly to reducing the incidence of inappropriate shocks in clinical practice. Rordorf: Programming of the S-ICD   Clinical Trial Registration URL: http://clinicaltrials.gov/ Identifier: NCT02275637 [ABSTRACT FROM AUTHOR]

Aims Patients with atrial fibrillation frequently experience sleep disorder breathing, and both conditions are highly prevalent in presence of heart failure (HF). We explored the association between the combination of an HF and a sleep apnoea (SA) index and the incidence of atrial high-rate events (AHRE) in patients with implantable defibrillators (ICDs). Methods and results Data were prospectively collected from 411 consecutive HF patients with ICD. The IN-alert HF state was measured by the multi-sensor HeartLogic Index (>16), and the ICD-measured Respiratory Disturbance Index (RDI) was computed to identify severe SA. The endpoints were as follows: daily AHRE burden of ≥5 min, ≥6 h, and ≥23 h. During a median follow-up of 26 months, the time IN-alert HF state was 13% of the total observation period. The RDI value was ≥30 episodes/h (severe SA) during 58% of the observation period. An AHRE burden of ≥5 min/day was documented in 139 (34%) patients, ≥6 h/day in 89 (22%) patients, and ≥23 h/day in 68 (17%) patients. The IN-alert HF state was independently associated with AHRE regardless of the daily burden threshold: hazard ratios from 2.17 for ≥5 min/day to 3.43 for ≥23 h/day (P < 0.01). An RDI ≥ 30 episodes/h was associated only with AHRE burden ≥5 min/day [hazard ratio 1.55 (95% confidence interval: 1.11–2.16), P = 0.001]. The combination of IN-alert HF state and RDI ≥ 30 episodes/h accounted for only 6% of the follow-up period and was associated with high rates of AHRE occurrence (from 28 events/100 patient-years for AHRE burden ≥5 min/day to 22 events/100 patient-years for AHRE burden ≥23 h/day). Conclusions In HF patients, the occurrence of AHRE is independently associated with the ICD-measured IN-alert HF state and RDI ≥ 30 episodes/h. The coexistence of these two conditions occurs rarely but is associated with a very high rate of AHRE occurrence. Clinical trial registration URL: http://clinicaltrials.gov/ Identifier: NCT02275637. [ABSTRACT FROM AUTHOR]

Aims A previous randomized study demonstrated that the subcutaneous implantable cardioverter defibrillator (S-ICD) was noninferior to transvenous ICD with respect to device-related complications and inappropriate shocks. However, that was performed prior to the widespread adoption of pulse generator implantation in the intermuscular (IM) space instead of the traditional subcutaneous (SC) pocket. The aim of this analysis was to compare survival from device-related complications and inappropriate shocks between patients who underwent S-ICD implantation with the generator positioned in an IM position in comparison with an SC pocket. Methods and results We analysed 1577 consecutive patients who had undergone S-ICD implantation from 2013 to 2021 and were followed up until December 2021. Subcutaneous patients (n = 290) were propensity matched with patients of the IM group (n = 290), and their outcomes were compared. : During a median follow-up of 28 months, device-related complications were reported in 28 (4.8%) patients and inappropriate shocks were reported in 37 (6.4%) patients. The risk of complication was lower in the matched IM group than in the SC group [hazard ratio 0.41, 95% confidence interval (CI) 0.17–0.99, P = 0.041], as well as the composite of complications and inappropriate shocks (hazard ratio 0.50, 95% CI 0.30–0.86, P = 0.013). The risk of appropriate shocks was similar between groups (hazard ratio 0.90, 95% CI 0.50–1.61, P = 0.721). There was no significant interaction between generator positioning and variables such as gender, age, body mass index, and ejection fraction. Conclusion Our data showed the superiority of the IM S-ICD generator positioning in reducing device-related complications and inappropriate shocks. Clinical trial registration Clinical Trial Registration: ClinicalTrials.gov; NCT02275637. [ABSTRACT FROM AUTHOR]

Syncopal events in patients with hypertrophic cardiomyopathy (HCM) are of concern as they are a vital consideration in algorithms for risk stratification for sudden cardiac death (SCD) and ICD implantation. However, the cause of syncope is often under-investigated and/or unexplained. Current syncope guidelines do not provide a detailed definition of unexplained syncope. To address this important gap, an international panel of experts in the field of both syncope and HCM wrote a consensus document with the aim of providing practical guidance for the diagnosis and management of syncope in patients with HCM. [ABSTRACT FROM AUTHOR]

Anti-tachycardia pacing (ATP) is frequently used to terminate ventricular tachycardia (VT), however it is not always successful and may accelerate VT requiring defibrillation. REVRAMP is a novel concept of ATP that involves delivering pacing at a faster rate than VT, but instead of abruptly terminating pacing after eight beats, pacing is gradually slowed until VT continues or normal rhythm is restored. In a pilot study we show that REVRAMP can restore normal rhythm, and that if REVRAMP is unsuccessful, VT is not accelerated.

Background: In response to the COVID-19 pandemic, the US states of New York and New Jersey instituted a "lockdown" that closed schools and most businesses except for essential services. The public was urged to remain at home. The 78-day lockdown period extended from 22 March 2020 to 6 June 2020. We sought to evaluate the impact of COVID-19 lockdown on continuously recorded physical activity in our patients with congenital heart disease with implanted cardiac rhythm management (CRM) devices—pacemakers (PPM), defibrillators (ICD) and implantable loop recorders (ILR) enabled with accelerometers that translate motion into a measure of active hours/day. Methods: All patients from our congenital CRM database with accelerometer-enabled devices who had stable cardiac status residing in NY and NJ were included. Forty-one patients met the inclusion criteria; the median age was 29.6 years (range 7–60); 54% female; 23 ICD, 15 PPM and 3 ILR. The patient activity was averaged for the 2 months prior to lockdown, during the lockdown, and the 2 months afterward. Paired t-tests were used to compare activity before and during lockdown, and before and after lockdown. Each patient served as his/her own control. Results: Active hours/day decreased by a mean of 32% (±27%) from baseline (p < 0.001). A total of 32 patients experienced a decline, 6 had no change and 3 had an increase. Active hours rebounded after lockdown and were unchanged compared to pre-lockdown levels. Conclusions: The COVID-19 lockdown in NY/NJ during the Spring of 2020 resulted in a significant drop in active hours/day in children and adults with congenital heart disease. Active hours/day rebounded to baseline after restrictions were lifted. [ABSTRACT FROM AUTHOR]

Purpose: The implantable cardioverter-defibrillator (ICD) is the therapy of choice for the prevention of sudden cardiac death. The number of elderly patients receiving ICDs is increasing. This study aimed to assess the outcome of patients according to their age at the time of implantation, and to identify variables potentially associated with patient survival. Methods: Between June 2009 and December 2019, we retrospectively enrolled all consecutive patients in whom ICD implantation had been performed for primary or secondary prevention at our center. Results: During the study period, 670 patients underwent ICD implantation. We stratified the population into four age-classes: Class 1 (23%) (pts aged less than 60 years), Class 2 (28%) (pts aged between 60 and 70 years), Class 3 (39%) (pts aged between 70 and 80 years) and Class 4 (9%) (pts aged 80 years or older). Over a median follow-up of 42 months, the rate of deaths in Class 4 was higher than in Classes 1 and 2 (log-rank test, P < 0.01), but was comparable to that in Class 3 (P = 0.407). With increasing age, we observed more complications at the time of implantation and during follow-up. On multivariate analysis, higher NYHA class, creatinine level and CHA2DS2-VASc score were identified as independent predictors of death, while age was not associated with worse prognosis. Higher body mass index, higher NYHA class and CHA2DS2-VASc score were also confirmed as independent predictors of hospitalizations or death due to any cause. Conclusion: This study showed good survival in ICD patients in all age-groups, including those aged ≥80 years. The CHA2DS2-VASc score seems to be a stronger predictor of death than age. [ABSTRACT FROM AUTHOR]

Cardiac implantable electronic devices (CIEDs) could still have adequate battery life and functionality when they are explanted after the death of the carrier, supposing an important resource for low- and middle- income countries where patients cannot afford new devices. The aim was to analyze the remaining battery life and reusability of CIEDs recovered from funeral homes. A descriptive study of postmortem explanted CIEDs was conducted. Devices were collected from three funeral homes in the Spanish region of the Basque Country (participation rate 33.3%). Devices with a remaining battery life of >75% or > 4 years, preserved external integrity and no evidence of malfunction were considered reusable. A total of 188 CIEDs were collected (175 pacemakers and 13 defibrillators). Of the total number of devices, 95 (50.5%) had enough battery to be interrogated. Among the interrogable devices, a total of 20 pacemakers (22.4%) had an estimated battery life of more than 4 years, as well as preserved integrity and no record of malfunction. A non-negligible number of postmortem explanted devices had battery life, external integrity and functionality to be considered reusable. Postmortem CIED donation could provide treatment to patients unable to afford new devices. [ABSTRACT FROM AUTHOR]

Background: To predict worsening heart failure hospitalizations (WHFHs), the HeartInsight multiparametric algorithm calculates a heart failure (HF) Score based on temporal trends of physiologic parameters obtained through automatic daily remote monitoring of implantable cardioverter-defibrillators (ICDs)., Objective: We studied the association of the baseline HF Score, determined at algorithm activation, with long-term patient outcomes., Methods: Data from 9 clinical trials were pooled, including 1841 ICD patients with a preimplantation ejection fraction ≤35%, New York Heart Association class II/III, and no long-standing atrial fibrillation. The primary end point was a composite of death or WHFH., Results: After a median follow-up of 631 days (interquartile range, 385-865 days), there were 243 WHFHs in 173 patients (9.4%) and 122 deaths (6.6%), 52 of which (42.6%) were cardiovascular. The primary end point occurred in 265 patients (14.4%). A multivariable time-to-first-event analysis showed that a high baseline HF Score (>23, as determined by a time-dependent receiver operating characteristics curve analysis) was significantly associated with the occurrence of the primary end point (adjusted hazard ratio [HR], 2.05; 95% confidence interval [CI], 1.54-2.71; P < .0001), all-cause death (HR, 2.37; CI, 1.56-3.58; P < .0001), cardiovascular death (HR, 2.19; CI, 1.14-4.22; P = .019), and WHFH (HR, 1.91; CI, 1.35-2.71; P = .0003). In a hierarchical event analysis of all-cause death as the outcome with highest priority and WHFHs as repeated event outcomes, the win ratio was 2.47 (CI, 1.89-3.24; P < .0001)., Conclusion: Based on a retrospective analysis of clinical trial data with adjudicated events, baseline HF Score derived from device-monitored variables was able to stratify patients at higher long-term risk of death or WHFH., Competing Interests: Disclosures G.B. received speaker’s fee from Abbott, Biotronik, Boston Scientific, Medtronic, and MicroPort. A.B. received consultant fees and/or grant support from Abbott, Biotronik, and Boston Scientific. M.S. received grant support from Abbott, Biotronik, Boston Scientific, and Medtronic., (Copyright © 2024 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Competing Interests: Disclosures Dr Williams reports Boston Scientific advisory board membership. Dr Brisben, Mr Al Koshiol, and Mr Nathan Carter are employees of Boston Scientific. Dr Saba reports research support from Abbott and Boston Scientific; and advisory board membership in Boston Scientific and Medtronic. All other authors have no conflicts of interest to disclose.

Abstract Objective To assess the clinical and radiographic factors associated with lead failure by comparing subjects with lead failure within 10 years of implantation with an implant‐year‐matched group without lead failure. Methods A case‐control study with 49 subjects who received Cardiac Implantable Electronic Device (CIED) between January 1, 1999 and July 31, 2008 and developed lead failure within 10 years of implantation in a single center. The control group consisted of subjects (n = 54) with normally functioning leads matched one‐to‐one by implant year. Results Among the failure group, the meantime from implantation to device lead failure was 4.70 ± 2.94 years. Older age at implantation was associated with a lower likelihood of lead failure (Odds Ratio (OR) = 0.28 (75 vs 42 years old), 95% CI 0.12‐0.63, P = .002). A larger smallest loop diameter on the chest radiograph was also associated with a lower likelihood of lead failure (OR = 0.51 (31 vs 14 mm), 95% CI 0.27‐0.97, P = .04). CIED type (defibrillator vs pacemaker) and Ottawa scores were not significantly associated with lead failure. Among lead‐specific parameters, defibrillation lead vs pace‐sense lead was associated with lead failure (OR = 3.91, 95% CI 1.95‐7.81, P

Background: Acceptance of the implantable cardioverter-defibrillator (ICD) device may be affected by a variety of factors. This study aimed to investigate the predictor roles of spiritual wellbeing, healthcare professionals' support and shock anxiety in accepting ICD. Methods: This cross-sectional study was conducted on 100 patients with ICD. The data were collected by the Florida Patient Acceptance Scale, Florida Shock Anxiety Scale, Spiritual Well-Being Scale and Healthcare Professionals' Support Questionnaire. Results: The mean (SD) scores of patient acceptance, shock anxiety, spiritual well-being and healthcare professionals' support were 65.4 (13.56), 21.93 (8.95), 88.92 (11.78) and 76.41 (10.54), respectively. The results revealed higher acceptance among the participants with lower shock anxiety levels (r = -0.51, P < 0.001), higher mean scores of spiritual well-being (r = 0.33, P = 0.001) and higher healthcare professionals' support (r = 0.40, P < 0.01). Additionally, the results of linear regression indicated that spiritual well-being, healthcare professionals' support and shock anxiety predicted 36% of the patient acceptance variance (R = 0.61, R² = 0.38, adj R² = 0.36) and shock anxiety and healthcare professionals' support were the predictors of patient acceptance. Conclusion: The study results indicated that the patients' mean score of acceptance was relatively high. In addition, the mean scores of shock anxiety, spiritual well-being and healthcare professionals' support were low, moderate and relatively high, respectively. Conducting healthcare professionals' support interventions, spiritual therapy and reducing shock anxiety can help patients accept ICDs. [ABSTRACT FROM AUTHOR]

To describe health related quality of life (HRQOL) and symptoms in the SPIRIT trial and determine effects of implantable cardioverter defibrillator (ICD) shocks on HRQOL over 24 months. Ninety participants aged 66 ± 10 years, 96% men, 75% with NYHA class II, with an ICD were randomized to spironolactone 25 mg (N = 44) or placebo (N = 46). HRQOL was measured every 6 months for 24 months using: Patient Concerns Assessment (PCA), Short Form Health Survey-Veterans Version (SF-36V), and Kansas City Cardiomyopathy Questionnaire (KCCQ). Linear mixed modeling compared changes in HRQOL over-time and ANCOVA compared HRQOL between those getting an ICD shock or not. Over 24-months, there were no differences in HRQOL between the spironolactone versus placebo groups. Those with at least one ICD shock reported significantly lower HRQOL and more symptoms at 6- and 24-months. Patients receiving one or more ICD shocks reported significant reductions in HRQOL and higher symptoms. [ABSTRACT FROM AUTHOR]

Introduction: Efficiency and safety are important features in the selection of lead extraction tools. We report our experience with different endovascular techniques to extract individual pacing and defibrillator leads. Methods: This is a single-centre study of consecutive lead extraction procedures from 1997 until 2019. A total of 1725 leads were extracted in 775 patients. Direct traction sufficed for 588 leads, and 22 leads were primarily removed by surgery. The endovascular techniques used in the remainder were a laser sheath (190 leads), the femoral approach (717 leads) and rotating mechanical sheaths (208 leads). Results: The three approaches were comparably effective in completely removing the leads (p = 0.088). However, there were more major complications with the laser sheath than with the femoral approach or rotating mechanical sheaths (8.4%, 0.5% and 1.2%, respectively). Therefore, the procedural result—extraction without major complications—was significantly better with both the femoral approach and rotating mechanical sheaths than with the laser sheath (p < 0.001). This result was confirmed after propensity score matching to compensate for differences between lead cohorts (p = 0.007). Cross-over to another endovascular tool was necessary in 7.9%, 7.1% and 8.2% of laser, femoral and rotating mechanical attempts, respectively. Conclusion: All three endovascular lead extraction techniques showed comparable efficacy. However, there were significantly more major complications using the laser sheath compared to the femoral approach or rotating mechanical sheaths, leading us to abandon the laser technique. Importantly, no single endovascular technique sufficed to successfully extract all leads. [ABSTRACT FROM AUTHOR]

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The article presents the discussion on societal impact arrhythmia papers reporting on important public health issues. Topics include foods and food supplements, health behaviours, work and sleep environment, and life events increasing the incidence of AF; and daily alcohol consumption of one standard drink being protective in myocardial infarction, heart failure, and stroke.

Background Implantable cardioverter‐defibrillators (ICDs) are indicated in patients with severe left ventricular dysfunction, but many eligible patients do not receive them, especially women and Black patients. Our group had previously demonstrated that a best practice alert (BPA) improves overall rates of electrophysiology referrals and ICD implantations. This study examined the impact of a BPA by sex and race. Methods and Results This is a cluster randomized trial of cardiology (n=106) and primary care (n=89) providers who were randomized to receive (BPA, n=93) or not receive (No BPA, n=102) the alert and managed 1856 patients meeting primary prevention criteria for ICD implantation (965 BPA and 891 No BPA). After a median follow up of 34 months, 630 (34%) patients were referred to electrophysiology, and 522 (28%) patients received an ICD. Compared with the No BPA arm, patients in the BPA arm saw a modest differential increase in the rate of electrophysiology referrals at 18 months in men (+4%) compared with women (+7%) but a profound increase in Black patients (+16%) compared with White patients (+2%), thus closing the sex and race gaps. Similar trends were noted for rates of ICD implantation. Conclusions Use of a BPA improves rates of electrophysiology referrals and ICD implantations in all comers with severe cardiomyopathy and no prior ventricular arrhythmias but has a more pronounced impact in women and Black patients. The use of a BPA at the point of care is an effective tool in the fight against sex and race inequities in health care.

The use of implantable cardioverter defibrillators (ICDs) in young women has been increasing in recent years owing to greater awareness about inherited cardiac conditions that increase the risk of sudden death. Traditional placement of ICDs in the infraclavicular region among young women often leads to visible scars, a constant prominence that causes irritation from purse or bra straps and can result in body image concerns and device-related emotional distress. In this case series, two women with long QT syndrome required placement of ICDs for prevention of sudden cardiac death. Submammary placement of ICDs was performed in collaboration with electrophysiologists. We describe our local experience and technique in submammary placement of ICDs as well as the challenges faced. [ABSTRACT FROM AUTHOR]

Purpose: We hypothesized that data in manufacturers' product performance reports (PPRs) can provide clinically valuable ICD and cardiac resynchronization defibrillator (CRT-D) reliability and longevity information.Methods: Data were obtained from 2019 PPRs. Kaplan-Meier (K-M) probabilities of freedom from malfunction, normal battery depletion (NBD), and NBD + malfunction were calculated for ICD and CRT-D pulse generators (PGs) with LiMnO2 or LiSVO/CFx batteries marketed in the USA from 2010 to 2019 and compared using the log-rank test. Malfunctions (MAL) included PGs that were found outside specifications.Results: Study population included 1,149,803 ICD and CRT-D PGs: Abbott (ABT; 35.1%), Biotronik (BIO; 4.6%), Boston Scientific (BSC; 23.5%), and Medtronic (MDT; 36.9%). Significant differences in reliability (p < 0.001), defined by freedom from MAL, were found between manufacturers; the majority of 6808 MAL occurred in ABT devices (n = 4045; 59.4%), followed by BSC (n = 2384; 35.0%), MDT (n = 338;5.0%), and BIO (n = 41; 0.6%). Battery failure (n = 890; 57.9%) was the most common cause of MAL compromising therapy; analysis of unique ABT battery MAL-indicated problem appeared a year prior to advisory. Significant differences (p < 0.001) in battery longevity, as defined by freedom from NBD, were found between manufacturers. Overall performance (freedom from NBD + MAL) favored BSC for CRT-D PGs and MDT and BIO for ICDs. BSC subcutaneous ICD reliability was inferior to its transvenous ICD (p < 0.001).Conclusion: PPRs contain valuable data that can be aggregated and analyzed to inform physicians. Differences in product reliability exist between manufacturers. Battery longevity has improved, but MAL have significantly impacted performance. PPR data may be useful for assessing product problems and new technology. [ABSTRACT FROM AUTHOR]

Abstract Background Due to demographic transition, multimorbidity and high numbers of medicinal products, polypharmacy rates will presumably further increase. This could lead to higher risks of potentially inappropriate medications with potential drug-drug interactions (PDDI). PDDI has already been investigated by several studies, but not for patients with indication for prophylactic implantation of a cardioverter defibrillator (ICD). Thus, the objective of this analysis was to examine the frequency of PDDI in that specific group of patients and compare patients with or without PDDI regarding potential underlying factors. Methods Cross-sectional data analyses were performed using data of the prospective EU-CERT-ICD study that primarily aimed to assess ICD effectiveness in Europe. Self-reported baseline medication data of patients from Germany and Switzerland were used. Patients who reported to take at least two drugs simultaneously for at least 80 days were defined as population at risk. By means of a publicly available interaction checker, we analyzed the medication data regarding occurrence and characteristics of PDDI categorized as minor, moderate, and major PDDI. The analyses were done using descriptive methods and chi square testing. Results The total population (n = 524) and the population at risk (n = 383) were rather similar with an average age of 64 years and about 80% male. PDDIs were found for 296 patients (in 57% of total population vs. 77% of population at risk). The moderate PDDI category was most frequently with 268 affected patients. Comparing patients with and without any PDDI, the proportion of patients with place of residence in Germany varied distinctly (93% vs. 78%). The frequency of any PDDI for the total population was twice as high in Germany as in Switzerland (p value

Background: Defibrillation testing (DT) can be omitted in patients undergoing transvenous implantable cardioverter–defibrillator (T-ICD) implantation, but it is still recommended for patients at risk for a high defibrillation threshold and for ICD generator changes. Moreover, DT is still recommended on implantation of subcutaneous ICD (S-ICD). The aim of the present survey was to analyze the current practice of DT during T-ICD and S-ICD implantations. Methods: In March 2021, an ad hoc questionnaire on the current performance of DT and the standard practice adopted during testing was completed at 72 Italian centers implanting S-ICD and T-ICD. Results: 48 (67%) operators reported never performing DT during de-novo T-ICD implantations, while no operators perform it systematically. The remaining respondents perform it for patients at risk for a high defibrillation threshold. DT is never performed at T-ICD generator change. At the time of de-novo S-ICD implantation, DT is never performed by 9 (13%) operators and performed systematically by 48 (66%). The remaining operators frequently omit DT in patients with more severe systolic dysfunction. DT is not performed at S-ICD generator change by 92% of operators. DT is conducted by delivering a first shock energy of 65 J by 60% of operators, while the remaining 40% test lower energy values. Conclusions: In current clinical practice, most operators omit DT at T-ICD implantation, even when still recommended in the guidelines. DT is also frequently omitted at S-ICD implantation, and a wide variability exists among operators in the procedures followed during DT.

Introduction: Patients with hypertrophic cardiomyopathy (HCM) are at risk for lethal ventricular arrhythmia, but the electrophysiological substrate behind this is not well-understood. We used non-invasive electrocardiographic imaging to characterize patients with HCM, including cardiac arrest survivors. Methods: HCM patients surviving ventricular fibrillation or hemodynamically unstable ventricular tachycardia (n = 17) were compared to HCM patients without a personal history of potentially lethal arrhythmia (n = 20) and a pooled control group with structurally normal hearts. Subjects underwent exercise testing by non-invasive electrocardiographic imaging to estimate epicardial electrophysiology. Results: Visual inspection of reconstructed epicardial HCM maps revealed isolated patches of late activation time (AT), prolonged activation-recovery intervals (ARIs), as well as reversal of apico-basal trends in T-wave inversion and ARI compared to controls ( p < 0.005 for all). AT and ARI were compared between groups. The pooled HCM group had longer mean AT (60.1 ms vs. 52.2 ms, p < 0.001), activation dispersion (55.2 ms vs. 48.6 ms, p = 0.026), and mean ARI (227 ms vs. 217 ms, p = 0.016) than structurally normal heart controls. HCM ventricular arrhythmia survivors could be differentiated from HCM patients without a personal history of life-threatening arrhythmia by longer mean AT (63.2 ms vs. 57.4 ms, p = 0.007), steeper activation gradients (0.45 ms/mm vs. 0.36 ms/mm, p = 0.011), and longer mean ARI (234.0 ms vs. 221.4 ms, p = 0.026). A logistic regression model including whole heart mean activation time and activation recovery interval could identify ventricular arrhythmia survivors from the HCM cohort, producing a C statistic of 0.76 (95% confidence interval 0.72-0.81), with an optimal sensitivity of 78.6% and a specificity of 79.8%. Discussion: The HCM epicardial electrotype is characterized by delayed, dispersed conduction and prolonged, dispersed activation-recovery intervals. Combination of electrophysiologic measures with logistic regression can improve differentiation over single variables. Future studies could test such models prospectively for risk stratification of sudden death due to HCM., Competing Interests: Medtronic has not influenced or sponsored any of the research here but has provided speaker fees to PK for a topic unrelated to this work. Imperial Innovations holds the patent for the intellectual property of the Ventricular Conduction Stability algorithm on behalf of the authors MS-S, KL, FN, AV, DF, and PK. The remaining authors declare that the research was conducted in the absence of any commercial or financial relationship that could be construed as a potential conflict of interest. The author(s) declared that they were an editorial board member of Frontiers, at the time of submission. This had no impact on the peer review process and the final decision., (Copyright © 2024 Chow, Leong, Shun-Shin, Jones, Guttmann, Mohiddin, Lambiase, Elliott, Ormerod, Koa-Wing, Lefroy, Lim, Linton, Ng, Qureshi, Whinnett, Peters, Francis, Varnava and Kanagaratnam.)

Background Optimal management of asymptomatic Brugada syndrome (BrS) with spontaneous type I electrocardiographic pattern is uncertain. Methods and Results We developed an individual‐level simulation comprising 2 000 000 average‐risk individuals with asymptomatic BrS and spontaneous type I electrocardiographic pattern. We compared (1) observation, (2) electrophysiologic study (EPS)‐guided implantable cardioverter‐defibrillator (ICD), and (3) upfront ICD, each using either subcutaneous or transvenous ICD, resulting in 6 strategies tested. The primary outcome was quality‐adjusted life years (QALYs), with cardiac deaths (arrest or procedural‐related) as a secondary outcome. We varied BrS diagnosis age and underlying arrest rate. We assessed cost‐effectiveness at $100 000/QALY. Compared with observation, EPS‐guided subcutaneous ICD resulted in 0.35 QALY gain/individual and 4130 cardiac deaths avoided/100 000 individuals, and EPS‐guided transvenous ICD resulted in 0.26 QALY gain and 3390 cardiac deaths avoided. Compared with observation, upfront ICD reduced cardiac deaths by a greater margin (subcutaneous ICD, 8950; transvenous ICD, 6050), but only subcutaneous ICD improved QALYs (subcutaneous ICD, 0.25 QALY gain; transvenous ICD, 0.01 QALY loss), and complications were higher. ICD‐based strategies were more effective at younger ages and higher arrest rates (eg, using subcutaneous devices, upfront ICD was the most effective strategy at ages 20–39.4 years and arrest rates >1.37%/year; EPS‐guided ICD was the most effective strategy at ages 39.5–51.3 years and arrest rates 0.47%–1.37%/year, and observation was the most effective strategy at ages >51.3 years and arrest rates

Background: When an implantable-cardioverter defibrillator (ICD) lead becomes non-functional, a recommendation currently exists for either lead abandonment or removal. Lead abandonment and subcutaneous ICD (S-ICD) implantation may represent an additional option for patients who do not require pacing. The aim of this study was to investigate the outcomes of a strategy of lead abandonment and S-ICD implantation in the setting of lead malfunction.Methods: We analyzed all consecutive patients who underwent S-ICD implantation after abandonment of malfunctioning leads and compared their outcomes with those of patients who underwent extraction and subsequent reimplantation of a single-chamber transvenous ICD (T-ICD).Results: Forty-three patients underwent S-ICD implantation after abandonment of malfunctioning leads, while 62 patients underwent extraction and subsequent reimplantation of a new T-ICD. The two groups were comparable. In the extraction group, no major complications occurred during extraction, while the procedure failed and an S-ICD was implanted in 4 patients. During a median follow-up of 21 months, 3 major complications or deaths occurred in the S-ICD group and 11 in the T-ICD group (HR 1.07; 95% CI 0.29–3.94; P = 0.912). Minor complications were 4 in the S-ICD group and 5 in the T-ICD group (HR 2.13; 95% CI 0.49–9.24; P = 0.238).Conclusions: In the event of ICD lead malfunction, extraction avoids the potential long-term risks of abandoned leads. Nonetheless the strategy of lead abandonment and S-ICD implantation was feasible and safe, with no significant increase in adverse outcomes, and may represent an option in selected clinical settings. Further studies are needed to fully understand the potential risks of lead abandonment.Clinical Trial Registration: URL: ClinicalTrials.gov Identifier: NCT02275637

Introduction: Obstructive sleep apnea is often underdiagnosed in atrial fibrillation (AF) patients although it is an important risk factor. A systematic review and meta‐analysis was performed to assess which techniques cardiac implantable electronic devices (CIED) and Holter monitors use to screen for sleep apnea (SA), and to evaluate if these are suitable for AF patients from a diagnostic accuracy perspective. Methods: The search was conducted in accordance with the PRISMA‐guidelines. PICO was defined as (P) patients with AF, (I) Holter monitors or CIED suitable for screening for SA, (C) overnight polysomnography (PSG), (O) positive screening with subsequent positive polysomnographic diagnosis of SA. Optimal index test cut‐off points corresponding to reference test cut‐off for severe SA (PSG‐AHI ≥ 30) were compared. Meta‐analysis was conducted for the diagnostic odds ratio (DOR), with forest plot and ROC‐curve for summary DOR. Results: A total of five prospective cohort studies (n = 192) were included in the systematic review of which four studies (n = 132) were included in the meta‐analysis. All included studies use transthoracic impedance measurement as a screening parameter. No studies evaluating Holter monitors were included. The population consisted of patients indicated for pacemaker implantation. The summary DOR was 27.14 (8.83; 83.37), AUC was 0.8689 (0.6872; 0.9456) and Q* was 0.8390 (0.7482; 0.9013). Conclusion: At optimal pacemaker‐cut‐off, pacemaker‐guided screening for severe SA in patients with AF can be an effective triage tool for clinical practice. Further studies with larger sample sizes are needed to strengthen the evidence for this conclusion. [ABSTRACT FROM AUTHOR]

Objective: To assess the clinical and radiographic factors associated with lead failure by comparing subjects with lead failure within 10 years of implantation with an implant‐year‐matched group without lead failure. Methods: A case‐control study with 49 subjects who received Cardiac Implantable Electronic Device (CIED) between January 1, 1999 and July 31, 2008 and developed lead failure within 10 years of implantation in a single center. The control group consisted of subjects (n = 54) with normally functioning leads matched one‐to‐one by implant year. Results: Among the failure group, the meantime from implantation to device lead failure was 4.70 ± 2.94 years. Older age at implantation was associated with a lower likelihood of lead failure (Odds Ratio (OR) = 0.28 (75 vs 42 years old), 95% CI 0.12‐0.63, P =.002). A larger smallest loop diameter on the chest radiograph was also associated with a lower likelihood of lead failure (OR = 0.51 (31 vs 14 mm), 95% CI 0.27‐0.97, P =.04). CIED type (defibrillator vs pacemaker) and Ottawa scores were not significantly associated with lead failure. Among lead‐specific parameters, defibrillation lead vs pace‐sense lead was associated with lead failure (OR = 3.91, 95% CI 1.95‐7.81, P <.001). Conclusions: Younger age, defibrillation leads, and small lead loops are associated with lead failure in CIEDs. Techniques to avoid tight loops in the pocket could potentially reduce the risk of lead failure and bear important implications for the implanting physician. [ABSTRACT FROM AUTHOR]

Cardiovascular implantable electronic devices have revolutionized the management of heart failure with reduced ejection fraction. New device generations tend to be launched every few years, with incremental improvements in performance and safety and with an expectation that these will improve patient management and outcomes while remaining cost-effective. As a result, today's cardiac resynchronization therapy (CRT) and implantable cardioverter defibrillator devices are quite different from the pioneering but often bulky devices of the late 20th century. This review discusses new and improved features developed to target specific needs in managing heart failure patients, some of which are especially pertinent to the current worldwide healthcare situation, with focus on the latest generation of CRTs with defibrillator (CRT-Ds) and implantable cardioverter defibrillators from Medtronic. [ABSTRACT FROM AUTHOR]

Cardiovascular implantable electronic devices (CIED) are effective and important components of modern cardiovascular care. Despite the dramatic improvements in the functionality and reliability of these devices, over time patients are at risk for developing several morbidities, the most feared of which are local and systemic infections. Despite significant financial investment and aggressive therapy with hospitalization, intravenous antibiotics, and transvenous lead extraction, the outcomes include a 1-year mortality rate as high as 25%. This risk of infection has increased over time, likely due to the increased complexity of the surgical interventions required to insert and replace these devices. The only way to reduce this morbidity and mortality is to prevent these infections, and other than preoperative antibiotics, there were little data supporting effective therapy until the WRAP-IT trial provided randomized data showing that pocket infections can be reduced by 60% at 12 months and major CIED infections reduced by 40% at 1 year with the use of the absorbable antibiotic eluting envelope in patient CIED procedures at high risk of infection. Not all CIED procedures are at high risk of infection and justify the use of the envelope, but cost-effectiveness data support the use of the antibiotic envelope particularly in patients with defibrillator replacements, revisions, and upgrades, such as to a resynchronization device and in patients with prior CIED infection, history of immunocompromise, two or more prior procedures, or a history of renal dysfunction. [ABSTRACT FROM AUTHOR]