Implantable Cardioverter Defibrillator Devices Research Articles

Routine chest X-ray post cardiac implantable electronic device implantation: is it really required? Experience from a tertiary centre

Abstract Introduction The 2021 EHRA expert consensus statement on pacemaker (PPM) and transvenous implantable cardioverter defibrillator (ICD) implant technique proposes a chest X-ray (CXR) prior to hospital discharge in all patients. This recommendation serves the dual purpose of excluding pneumothorax following subclavian or axillary access (SAA) and documenting lead position. Purpose Given that cephalic venous access (CA) precludes pneumothorax, the utility of CXR as a tool for identifying early lead displacement (LD) in these patients warrants further examination. We studied the yield of post implant CXR, device interrogation (DI), or both for the identification of pneumothorax and LD in patients undergoing transvenous PPM or ICD implant via SAA or CA. Methods 4,051 consecutive PPM or ICD devices were implanted at a tertiary centre between 2016-2019. Lead position was documented fluoroscopically on conclusion of all procedures. A subsequent post implant CXR was performed in cases of SAA, plus in those CA patients requiring imaging for another indication (e.g. pulmonary oedema). Post implant DI was only performed in patients with a high anticipated burden of ventricular pacing (e.g. high-grade atrioventricular block). All patients underwent clinical review with repeat DI at 30 days post implant. LD was defined as a clinically significant translocation of a lead requiring repositioning or reprogramming. Results For the whole cohort, the incidence of LD at 30 days was 2.2% (n=89), and the incidence of pneumothorax (within the SAA group) was 0.9% (n=11). The venous access method used, post implant investigations, and the incidence of LD is shown in Figure 1. 1,282 patients (31.6%) required SAA; CXR was performed in all, and 9 LDs were identified (0.7%). However, four patients (0.3%) with ‘normal’ CXRs had evidence of LD on inpatient DI, and a further 17 LDs (1.3%) were confirmed on the 30 day DI despite a ‘normal’ CXR. 2,769 patients (68.4%) underwent CA; 309 (11%) required CXR. This identified LD in four patients (1.3%), with three further patients (1%) found to have LD on subsequent inpatient DI despite a ‘normal’ CXR. A further four LDs (1.3%) were diagnosed at 30 day DI. The majority (89%, n=2,460) of CA patients were discharged without CXR. 30% (n=825) of these patients required inpatient DI; this identified 13 LDs (1.6%). Accordingly, 59% (n=1,635) of CA patients had no post procedural investigations; 24 (1.5%) were found to have LD at 30 day DI. Conclusions In patients who developed LD within 30 days of a PPM or ICD implant, a post implant CXR identified this in only 32% of cases (n=13/41), and the overall sensitivity of CXR for LD was low (50%). Additionally, the majority of LDs (54%) occurred after hospital discharge. We suggest that the utility of post implant CXR for identifying LD is limited, and that CXR should not be considered an essential investigation in CA device implants.Figure 1

Targeting ventricular tachycardia originating from the anterolateral papillary muscle with stereotactic body radioablation therapy

Abstract Background Ventricular Tachycardia (VT) is prevalent in the setting of non-ischaemic cardiomyopathy (NICM), a heterogeneous group of conditions characterized by myocardial dysfunction in the absence of coronary artery disease. Challenges of catheter ablation to treat VT in NICM patients are well known, and recurrence rates can be as high as 58%. Stereotactic body radioablation therapy (SBRT) involves precise delivery of radiation to arrhythmogenic substrates, and represents a novel treatment to reduce recurrent implantable cardioverter defibrillator (ICD) therapies in patients with refractory VT. Though SBRT has shown preliminary effectiveness in reducing VT episodes, its effectiveness in NICM patients has not been widely evaluated. Purpose To evaluate SBRT effectiveness in NICM patients with scars at the basal anterolateral papillary muscle at a tertiary care center between November-December 2022. Methods Eligible patients had their VT substrate mapped using a single-use ECGI vest and a 4D-CT simulation scan. In addition, MRI scans were used to aid anatomical identification of the anterolateral papillary muscle which could not be seen on the non-contrast diagnostic CTs. SBRT was delivered in a single fraction of 25 Gy under image guidance. Effectiveness of the treatment was evaluated as changes in frequencies of total antitachycardia pacing (ATP) and ICD shock episodes from 6 months pre-, and within to 3, 6, and 12 months follow up post SBRT. Results Participants were 3 males with NICM, aged 56, 60, and 73 with previous dual chamber ICD implantation, 2 of whom had a history of VT ablation/ VT storm and paroxysmal atrial fibrillation. All participants had basal lateral scar, and were receiving beta blockers, mexiletine, and amiodarone with refractory VT before SBRT treatment. Prior to SBRT, ICD device interrogation showed a total of 119 (77, 7, and 35 in patients 1-3 respectively) ATPs, and 27 (10, 1, and 16 in patients 1-3 respectively) ICD shocks delivered. At 12 month follow-up, none of the participants experienced any episodes of ATP or ICD shock. Ejection fraction remained consistent pre-post SBRT. Conclusion SBRT showed remarkable success in reducing ATP and ICD shock episodes, facilitating uncomplicated 1 year follow-up in 3 male patients with NICM and VT from the anterolateral papillary muscle.

Predictors of death without prior appropriate therapy in ICD recipients: the comorbidities, frailty and functional status (COMFFORT study)

ObjectiveMost patients who have an implantable cardioverter-defibrillator (ICD) implant do not receive life-prolonging therapy from it. Little research has been undertaken to determine which patients benefit the least from ICD...

Anxiety and depression in patients with an implantable cardioverter defibrillator does personality and icd expectations play a role?

Abstract Background The implantable cardioverter defibrillator (ICD) is the treatment of choice for the prevention of sudden cardiac death. Given that 22.6% of patients with an ICD develop anxiety and 15.4% depression (1), it is paramount to identify factors contributing to their distress. Anxiety may lead to depression if untreated and both have been associated with risk of morbidity and mortality. Purpose To examine if Type D personality and expectations to ICD therapy are associated with anxiety and depression in ICD patients at 12 months follow-up. Methods Patients with a first-time ICD or cardiac resynchronization therapy device (CRT-D) participating in the national Danish ACQUIRE-ICD trial completed the Type D Scale (2), the EXPECT-ICD Scale containing both negative and positive expectations at baseline, the Generalized Anxiety Disorder scale (GAD-7), and the Patient Health Questionnaire (PHQ-9) to determine anxiety and depression, respectively, both at baseline and 12 months follow-up. Results Of the 478 patients participating in the study, the mean age was 60.2 ± 11.2, 397 (83.1%) were male and 81 (16.9%) women. Of all patients, 255 (53.3%) had a primary prevention indication for the ICD and 223 (46.7%) a secondary prevention indication, while 441 (92.3%) were in NYHA Class I-II and 37 (7.7%) in NYHA class III-IV at the time of implant. With respect to personality, 73 patients (15.3%) had a Type D personality. Mean scores on Positive expectations towards ICD implantation were 12.8 ± 3.18, and mean scores on negative expectations were 5.37 ± 3.30. In the multivariate, adjusted analysis for depression, Type D personality was independently associated with 12 months depression scores, over and above the impact of baseline depressive symptoms (B = 2.43, 95% CI [1.42, 3.43], p < .001). ICD expectations were not significantly associated with 12 months depression scores. In the multivariate, adjusted analysis for anxiety, Type D personality was independently associated with 12 months anxiety scores, over and above the impact of baseline anxiety symptoms (B = 1.90, 95% CI [1.07, 2.73], p <.001). ICD expectations were not significantly associated with 12 months depression scores. Conclusion In a large Danish national cohort of ICD patients, depressive symptoms at baseline and Type D personality were associated with increased depressive symptoms at 12 months follow-up. Neither positive nor negative ICD expectations were associated with depressive symptoms at 12 months follow-up, adjusting for other variables. Similar results were found for anxiety symptoms. Anxiety symptoms at baseline and Type D personality were associated with increased anxiety at 12 months follow-up, adjusting for all other variables, including ICD expectations. It may be worthwhile to screen cardiac patients for this personality type in clinical practice.

Accuracy and Functionality of Select Continuous Glucose Monitoring Systems Are Not Impacted by Implantable Cardioverter Defibrillator Devices.

Increasing numbers of individuals with diabetes are adopting use of continuous glucose monitoring (CGM) in their daily self-management. Many of these individuals have advanced heart disease. Implantable cardioverter defibrillator (ICD) devices can effectively reduce arrhythmic death and all-cause mortality in individuals with advanced heart disease. However, the potential impact of ICD devices on CGM system accuracy and functionality has not been well studied. This evaluation assessed whether FreeStyle Libre (FL) CGM systems can coexist and function within the same patient in the presence of wireless interference devices, including current ICD devices. Interferer sources included Wi-Fi devices, Bluetooth devices, cellular mobile devices, implantable medical devices, Bluetooth Low-Energy (BLE) devices, BLE accessory devices and BLE mobile devices, and ICD-programmer interferers. Five testing methodologies were used to evaluate the accuracy and functionality of the CGM systems when exposed to ICD functions: high-energy emergency shocking, pacing modes, anti-tachycardia pacing mode (ATP), and DC Fibber mode. All acceptance criteria and testing requirements were met for the CGM and ICD system for wireless coexistence evaluation. Our findings demonstrated that coexisting ICD devices and FL CGM systems provide safe and effective wireless communications with functional and accurate transfer of data during scenarios expected in clinical use.

Incidence, implications, and management of sense-B-noise failure in subcutaneous cardioverter-defibrillator patients: insights from a large multicentre registry.

Subcutaneous implantable cardioverter-defibrillators (S-ICDs) offer potentially distinct advantages over transvenous defibrillator systems. Recent randomized trials showed significantly lower lead failure rates than transvenous ICD. Still, S-ICDs remain associated with the risk of inappropriate shocks (IAS). While previous studies have reported varying causes of IAS, this study explores a rare cause of IAS, referred to as 'sense-B-noise.' It was recently described in case series, but its incidence has not been studied in a large cohort of S-ICD patients. We retrospectively reviewed data from patients implanted with S-ICD models 1010, A209, and A219 between October 2009 and July 2023 across nine centres in Europe and the USA. The analysis concentrated on determining the incidence and understanding the implications of sense-B-noise events. Sense-B-noise represents a rare manifestation of distinct electrogram abnormalities within the primary and alternate sensing vectors. Data were collected from medical records, device telemetry, and manufacturer reports for investigation. This registry is registered on clinicaltrials.gov (NCT05713708). Subcutaneous implantable cardioverter-defibrillator devices of the 1158 patients were analysed. The median follow-up time for all patients was 46 (IQR 23-64) months. In 107 patients (9.2%) ≥1 IAS was observed during follow-up. Sense-B-noise failure was diagnosed in six (0.5 and 5.6% of all IAS) patients, in all patients, the diagnosis was made after an IAS episode. Median lead dwell time in the affected patients was 23 (2-70) months. To resolve the sense-B-noise defect, in three patients reprogramming to the secondary vector was undertaken, and two patients underwent system removal with subsequent S-ICD reimplantation due to low amplitude in the secondary vector. In one patient, the secondary vector was initially programmed, and subsequently, an S-ICD system exchange was performed due to T-wave-oversensing IAS episodes. This multicentre analysis' findings shed light on a rare but clinically highly significant adverse event in S-ICD therapy. To our knowledge, we provide the first systematic multicentre analysis investigating the incidence of sense-B-noise. Due to being difficult to diagnose and limited options for resolution, management of sense-B-noise is challenging. Complete system exchange may be the only option for some patients. Educating healthcare providers involved in S-ICD patient care is crucial for ensuring accurate diagnosis and effective management of sense-B-noise issues.

Diagnosis of cardiac electrical storm before and after implantable cardioverter defibrillator device therapy: a case report

Diagnosis of cardiac electrical storm before and after implantable cardioverter defibrillator device therapy: a case report

Larger change in intra-thoracic impedance before and during heart failure hospitalization is associated with longer length of stay in patients with cardiovascular implanted electronic devices

Abstract Background Intra-thoracic impedance measured in implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy defibrillators (CRTD) is a measure of intravascular blood volume and have been shown to correlate with intracardiac pressures in previous studies. Purpose We investigated whether amount of change of intrathoracic impedance before admission is associated with length of stay (LOS) during heart failure (HF) hospitalizations in a large real-world cohort of patients with ICD/CRTD devices. Methods We linked a deidentified database of aggregated electronic health record during the period from 2007-2017 to a manufacturer’s device data warehouse with device based continuous diagnostic monitoring data. Patients with ICD/CRTD implants with intra-thoracic impedance measurements were included for this study. HF event was defined as an inpatient, emergency department, or observation unit stay in a hospital with primary diagnosis of HF and intravenous diuretics administration. Relative change of daily intra-thoracic impedance measurement from 60 days prior to admission and date of admission as well as from admission to discharge were compared in HF events with LOS < 5 days and LOS ≥ 5 days using a Wilcoxon rank sum test. Results A total of 17,886 patients with 1.8±1.2 years of follow-up met inclusion criteria. The average age of patients was 66.6 ±12.3 years, with 72% being males, and 51% with ICD devices. The relative change in intra-thoracic impedance from 60 days prior till date of admission and from admission to discharge for HF events with LOS < 5 days and LOS ≥ 5 days are shown in Table. A total of 1456 patients had 1720 HF events of which 874 events had LOS< 5 days and 846 had LOS≥ 5 days. HF events with a longer length of stay (LOS ≥ 5 days) had a higher relative decrease in intra-thoracic impedance prior to admission compared to HF events with a shorter length of stay. HF events with a longer length of stay (LOS≥ 5 days) had a higher relative increase in intra-thoracic impedance during hospital stay. Conclusions In a large real-world population of patients with ICD/CRTD devices, longer length of stay is more likely in patients with a larger relative decrease in intra-thoracic impedance prior to admission, indicating more accumulated fluid. Further, larger relative increase in intra-thoracic impedance during hospital stay was observed in patients with longer length of stay, indicating more fluid removal.

The role of infliximab in treating refractory cardiac sarcoidosis

Abstract Introduction Cardiac sarcoidosis (CS) is associated with therapeutic challenges, and a high morbidity and mortality. Tumour necrosis factor alpha inhibitors like infliximab may be a treatment option for patients with persistent myocardial inflammatory activity despite conventional immunosuppressive treatment with steroids and steroid-sparing agents. Purpose To identify the safety and efficacy of infliximab in the treatment of refractory cardiac sarcoidosis. Methods We conducted a review of refractory CS patients who had been or were actively on treatment with Infliximab at our specialist tertiary care hospital from January 2017 to January 2023. Serial echocardiographic and FDG-PET scan changes as well as long term clinical data on morbidity and mortality was recorded. Results Six CS patients on infliximab were retrospectively identified. The mean age at CS diagnosis was 47.0±5.9 years and mean duration between CS diagnosis and starting infliximab was 21.4±14.2 months (Table 1). Infliximab was commenced due to persistent inflammation on FDG-PET scan and/or CMR despite being on at least two agents (prednisolone and methotrexate ± hydroxychloroquine) in 5 cases and prednisolone alone (intolerance to methotrexate) in one case. At baseline, 3 patients presented with ventricular arrhythmias, 2 with atrioventricular block and 2 with heart failure. After a mean follow up of 21.2±15.5 months of being on infliximab, 5/6 CS patients had decreased myocardial uptake on PET (1 was awaiting a scan) which included complete resolution of FDG-PET signal in one patient (Table 2). A trend in improvement of mean LVEF [52.7±6.6% to 60.2±5.9%, p = 0.10] and reduction of mean prednisolone dose [19.2±6.6mg to 11.3±7.0mg, p = 0.08] was observed during Infliximab treatment. None of the patients had worsening of LVEF or admission with acute heart failure whilst being on infliximab. A total of 4/6 patients had an Implantable Cardioverter Defibrillator device in situ at the time of Infliximab initiation. No major arrhythmias were observed during follow up. One patient died following complications of patent foramen ovale repair. There were three new cases of infection (1 pneumonia and 2 COVID-19 pneumonitis) and one case of renal cell carcinoma diagnosis three years after Infliximab treatment initiation. The drug safety was overall satisfactory since none of the patients required hospitalisation (Table 2). Case 2 patient stopped infliximab after 13 months of treatment and was found to have disease relapse seven months later. During a 20 month follow up of being on infliximab again, he demonstrated complete resolution of FDG uptake on subsequent FDG-PET scan. Conclusion This study supports the use of infliximab in refractory CS by demonstrating improvement in clinical, functional and tissue characterization parameters. However, infliximab is associated with an increased risk of infections.

Lead extraction of very old leads using the PISA technique - experience of a portuguese tertiary care center

Abstract Background The "Pisa Technique" (PT) is an increasingly used method of lead extraction (LE) that is associated with the lowest rate of complications reported in the ELECTRa Registry. Lead dwell time has been recognized as the highest risk factor for extraction failure and procedure-related complications. Purpose To investigate the safety and efficacy of LE, using the PISA technique, of very old cardiac implantable electronic devices (CIED) leads. Methods Patients submitted to LE of very old leads (with an implant duration of more than 10 years) between February 2013 and October 2022 (Old group), were compared with a contemporary cohort of patients subjected to LE of leads with a shorter implant duration (New group). The PT was used in all patients. Demographic, clinical, and patient-related variables, complications, mortality, and reimplantation data were assessed. Results A total of 150 very old leads were removed from 86 patients in the Old group, and a total of 305 leads were removed from 171 patients in the New group during the study period. Regarding the baseline characteristics, patient mean age was 69.5±16.9 years, 82.6% were male. Nine patients (10.5%) had cardiac resynchronization devices, 11 (12.8%) implantable cardioverter-defibrillator devices, and 66 (76.4%) pacemaker systems (mostly DDD). Of the total LE in the Old group, 88.4% were due to CIED infection (44.1% with valvular or lead endocarditis) vs 75.9% (p=0.464) vs the New group. The mean "age" of the extracted leads was 163.7±53.4 vs 46.6±34.9 months, and there were more of active fixation in the New group 35.2% vs 58.9%, p<0.01. A previous attempt of LE had been done in 5.8% vs 11.1% (p=0.172) of the patients, there were more previous generator replacements in the Old group 67.4% vs 23.7% (p<0.01). The radiographic success rate of the attempted lead extractions was similar between both groups 90.7% vs 96.5% (p=0.063). The clinical success rate was slightly lower in the Old group 95.3% vs 99.4% (p=0.031). The procedure major complications rate in the Old group was 2.3% (there were 2 cases of cardiac tamponade that required sternotomy with no laceration of the SVC observed) vs 1.2% (p=0.294) in the New group. Minor complications occurred in 11.6% vs 8.8% (p=0.466) of the LE (mostly comprised of infected pocket hematomas). No deaths occurred during the procedures, and there was no extraction-related mortality in both groups. Conclusion Our center’s experience with the PISA technique confirms the method’s safety and feasibility for the percutaneous extraction of very old CIED leads.

Assessing the benefit of a replacement implantable cardioverter-defibrillator device for primary prevention of sudden cardiac death

Abstract Background Implantable cardioverter-defibrillators (ICDs) have been shown to reduce the burden of sudden cardiac death in at-risk populations. However, data reflecting contemporary device programming and medication would be valuable, particularly when evaluating patients for a replacement ICD when they did not receive therapy from their original device. Purpose This real-world analysis examined the incidence of ICD therapy after routine generator replacement due to battery depletion in patients who didn’t receive therapy from their first ICD. Methods Data were obtained from a query of a deidentified database from 2007 to present. The final analysis included patients that underwent a generator replacement after 2012 due to battery depletion and who had received no therapy from their first ICD. Patients were divided into two groups based on their ICD indication status (primary prevention [PP] or secondary prevention [SP]). The main endpoint was time to first appropriate shock therapy, antitachycardia pacing (ATP) therapy, or any therapy (ATP or shock) after ICD replacement. Time to first therapy was plotted using the Kaplan-Meier method. Appropriateness of therapy was modeled via LASSO regression using characteristics present in both our dataset and the adjudicated PainFree SST trial. The model was fit on episodes from 80% of PainFree SST patients and validated on the remaining 20% before applying it to our dataset. Results A total of 8,383 patients were identified who met the criteria outlined above. Of these patients, 7,299 (66.3 ± 12.6 years old; 30.3% female) had a PP indication for an ICD and 1,084 (64.2 ± 14.0 years old; 30.3% female) had an SP indication. The mean longevity of initial ICD implants before replacement was similar in PP and SP patients (91.4 ± 16.2 vs 90.9 ± 16.3 months). At 7 years post-replacement, the incidence of first shock, ATP, or any therapy received by PP patients who did not receive first-device therapy was 16%, 23% and 27% respectively. After applying the model to estimate appropriateness of therapy, the appropriate therapy rates were 14%, 22%, and 26%, respectively (Figure 1). Similarly, SP patients who received no first-device therapy had an incidence of modeled first appropriate shock, ATP, and any therapy 7 years after ICD replacement of 12%, 20%, and 25%, respectively. The modeled 7-year inappropriate shock rate post-replacement was 4% in all patients. Conclusion In this large, long-term, real-world evaluation of ICD PP patients who hadn’t experienced a treated event with their initial device, 1 in 4 eventually received appropriate therapy from their second device. The results suggest that the underlying risk persists in these patients and device replacement may be necessary to protect them from experiencing a deadly event.

Arrhythmic form of mitral valve prolapse: presentation, risk stratification and management

Abstract Background Mitral valve prolapse (MVP) is a common finding that has been considered as benign condition for a long time. However, some anatomic forms have been recently recognized to be associated with life-threatening ventricular arrhythmia and sudden cardiac death (SCD), recently known as arrhythmic MVP (AMVP). Objectives This study is aiming to clinically characterize and risk stratify patients with malignant phenotype of MVP of high risk for ventricular arrhythmia which may lead to SCD. We aim to explore characteristics and assess potential markers for MVP induced ventricular arrhythmia that might need monitoring and follow up with medical or invasive treatment as implantable cardioverter-defibrillator, catheter ablation or even surgical repair. Methods A prospective cohort study of 45 (age 35±8, 29 females), consecutive patients with MVP and/or mitral annular disjunction (MAD) and comprehensive clinical arrhythmia on resting electrocardiography (ECG) or 48-hours Holter monitoring , Doppler echocardiography and contrast based cardiac magnetic resonance (CMR) characterization were identified. Patients were followed-up for a period of maximum one year to identify any further management needed. Results Frequent ventricular arrhythmia was evidently seen associated to MVP (69% with at least ventricular ectopy ≥5%), as well as complex ventricular arrhythmia (31% with sustained or non-sustained ventricular tachycardia ) P<0.001. AMVP was strongly associated with premature ventricular contractions (PVCs) having Right bundle branch block (RBBB) morphology on ECG and late gadolinium enhancement (LGE) on CMR (all p<0.05). Furthermore, it was shown to be associated with bileaflet prolapse and higher left ventricular volumes, however not statistically significant. On Follow-up, Out of 36 patients with ventricular arrhythmia, 64% were controlled on medical anti-arrhythmic and some others were referred either for ablation after worsening of symptoms despite of medical treatment (27.8%), implantable cardioverter-defibrillator device for secondary VT prophylaxes (5.6%) or surgery (2.8%) due to progression in mitral regurgitation severity and deterioration of symptoms. Conclusion In this small cohort study, characteristic form of MVP was found to be associated with ventricular arrhythmia more common in the form of frequent PVCs and less common in the complex form. Although majority of patients were controlled on medical treatment, few patients required further invasive management despite of medical treatment . Thus, arrhythmia associated with a special form of MVP could be life threatening and needs close monitoring, long follow-up and proper management approach to prevent SCD. Large prospective studies with comprehensive approach and long term follow up is pivotal. CMR T1 mapping and electro anatomical CARTO mapping could help in better detection and proper defining of arrhythmia substrate in future studies.AMVP illustration

Combined subcutaneous implantable cardioverter defibrillator and pacemaker devices in complex congenital heart disease: a single-center experienced based study.

Subcutaneous implantable cardioverter defibrillators (S-ICD) are widely accepted therapy in congenital heart disease (CHD) patients at risk of life-threatening ventricular arrhythmias or sudden cardiac death (SCD) when pacing is not required. Occasionally, pacemaker (PM)-dependent CHD patients will subsequently develop an indication for a cardioverter defibrillator. The use of S-ICD in complex CHD patients who have had already PM devices implanted implies some specific considerations, as the safety for these patients in unknown and recommendations among physicians may vary widely. We review the data and studied the indications for S-ICD in complex CHD with previous PM and discuss its usefulness in clinical practice. From a large cohort of 345 patients enrolled in the S-ICD Monaldi care registry, which encompass all the patients implanted in the Monaldi Hospital of Naples, we considered 11 consecutive complex CHD patients (10M/1F aged 40.4 ±18.4 years) who underwent S-ICD implant after a previous PM implant, from February 2015 to October 2022. Mean follow-up was 25.5 ± 22 months. All the patients showed a good compliance to the device system with no complications (infections or skin erosions). In complex CHD with already implanted PM devices, S-ICD implant appears to be a safe alternative to PM upgrading to transvenous ICD system, avoiding abandoned leads or life-threatening lead extraction. However, there are important issues with regard to testing and programming that need to be addressed at the time of implantation.

THU662 Poor Response To Medical Treatment In A Patient With Amiodarone-induced Hyperthyroidism: A Therapeutic Dilemma

Abstract Disclosure: A.A. Asiri: None. R. Sulimani: None. W. Alkhidady: None. Introduction: Hyperthyroidism is a well-known complication of amiodarone therapy. An incidence of 3% is reported in North America1, and even higher percentages in amiodarone deplete areas of about 10%.2 Treatment of amiodarone-induced hyperthyroidism (AIH) is challenging, it depends on various factors including the type of AIH, dependence of the patient’s cardiac condition on amiodarone therapy, other complications or comorbidities of the patient such as hepatic injury or dysfunction and the response of the patient to antithyroid therapy. Clinical Case: We present a case of a 32-year-old lady with a therapeutic dilemma in treating type I AIH, resistant to medical therapy. Our patient first had acquired COVID-19-induced myocarditis in 2020 and subsequently developed sustained ventricular tachycardia and was treated with amiodarone and placed on an implantable cardioverter-defibrillators (ICD) device. Two years later in 2022, the patient developed type I amiodarone-induced hyperthyroidism, with a free T4 reaching 100 pmol/L (Reference range 15-22 pmol/L) and complicated with transaminitis. She was unresponsive to medical therapy including: anti-thyroid medications, IV high-dose hydrocortisone, potassium iodide drops, and cholestyramine. She also developed adverse events with two of the antithyroid medications, Carbimazole and PTU; where she had elevated liver enzymes more than five time upper limit of normal and a generalized skin rash with PTU. Plasmapheresis was not an option as some of her cardiac medications drug levels could be affected. She underwent an emergent total thyroidectomy with dual beta blockade (Propranolol and Sotalol) successfully without any post op events. Her T4 level normalized within 8 days of her operation and her liver enzymes normalized within 2 weeks. Conclusion: We report the success and safety of surgical management in a patient with a cardiac arrhythmia and uncontrolled severe amiodarone-induced hyperthyroidism in the setting of adequate beta blockade.

Incidence of Radiotherapy Induced Cardiac Implantable Electronic Devices Malfunction: Australian-Based Observation Study.

To assess the incidence rate of cardiac implantable electronic devices (CIED) malfunction with radiotherapy (RT) and identify factors resulting in CIED malfunction. The working hypothesis is that CIED malfunction is associated with higher photon beam energy, treatment anatomical location, device type and dose to device. This retrospective review involved 441 patients with CIED treated with RT. Clinical information, RT (prescription, dose to device, beam energy, anatomical regions treated etc.) and CIED details (type, manufacturer, and device malfunction) were collected from electronic medical records. A total of 344 patients (78%) had a permanent pacemaker (PPM), 44 patients (10%) had implantable cardioverter defibrillator (ICD), 44 patients (10%) had CRT-defibrillator (CRT-D) and 9 (2%) had cardiac resynchronization therapy-pacing (CRT-P). The median prescribed dose was 36 Gy (IQR 1.8-80 Gy). 17 out of 441 patients (3.9%) experienced an CIED malfunction event. This group had a higher prescribed median dose of 42.5 Gy (IQR 20-77 Gy) and beam energy of 14 MV (12-18 MV). None of the malfunctions resulted in clinical symptoms. Median dose to CIED was 0.28 Gy (IQR 0-3.3). No patents received dose to device ≥2 Gy. Using logistic regression, the predictors of CIED malfunction were photon beam energy use ≥10 MV (OR 5.73; 95% CI, 1.58-10.76), anatomical location of RT above the diaphragm (OR 5.2, 95% CI, 1.82-15.2), and having an ICD (OR 4.6, 95% CI, 0.75-10.2). We have demonstrated that photon beam energies ≥10 MV, RT to above the diaphragm and ICD devices are significantly associated with CIED malfunction. The recorded CIED malfunctions in this study were minor malfunctions which did not result in any clinical symptoms. Stringent adherence to the local institution's CIED treatment guidelines, utilization of safety measures and careful choice of beam energy are recommended to minimize risk of symptomatic CIED malfunctions.

New old life of patients after implantation of implantable cardioverter-defibrillator

The aim of this article is to provide a detailed description of patients' lives after implantation of an implantable cardioverter defibrillator (ICD). First, the basic function and mechanism of the device as well as the types of experienced shocks, including phantom shocks, are described. Then, the three most important dilemmas faced by patients are discussed: ICD implantation, battery replacement and device deactivation. Subsequently, the scientific literature on psychopathological symptoms in patients is reviewed. The latest results of research on anxiety and depression in patients with ICD are presented, and the relationship between anxiety and depression and experienced shocks is discussed in detail. The results of a few studies on the occurrence of stress and post-traumatic stress disorder in patients are also presented. In addition, the focus was on the perception of the implantation of a cardioverter defibrillator as a traumatic event. The aim of this article was also to discuss the quality of life of patients with a cardioverter defibrillator. The results of studies that indicate a deterioration, improvement or maintenance of the level of quality of life of patients comparable to those of healthy people are presented. In addition, a specific, important from the perspective of people with ICD aspect of the quality of life, which is the health-related quality of life, was discussed. The results of research in this area are also not unambiguous. In addition, predictors of health-related quality of life were indicated. The article also addresses the issue of changing the identity of patients after implantation of a cardioverter defibrillator. The results of research conducted in this field, which were most often of a qualitative nature, were discussed. In the discussion on the identity of people with ICD, changes in self-image were emphasized, but this issue was not a frequent subject of psychological research. Finally, the challenges faced by partners of patients with an implanted cardioverter defibrillator were characterized. Also in this area, most of the research was qualitative, and the data come from interviews with relatives of cardiac patients.

Low Risk of Inappropriate Shock Among Pediatric Patients With an Implantable Cardioverter Defibrillator: A Single Center Experience.

Implantable cardioverter-defibrillators (ICD) are increasingly being used among the pediatric population for indications of both primary and secondary prevention. There is limited long-term data on the outcomes of pediatric patients following ICD implantation. The aim of this study was to investigate the characteristics of this population, burden of appropriate and inappropriate shock and complication rate in a large tertiary pediatric medical center. Included were children under the age of 18years who underwent ICD implantation and had clinical follow up at our center. Data were retrospectively collected between study period 2005-2020. Primary outcome was the incidence of ICD shock appropriate and inappropriate. Secondary outcome was defining our patient population characteristics. Our cohort included 51 patients who underwent ICD implantation. Mean age at implantation was 10.9 ± 4.7years and average follow-up time was 67months. Diagnoses of implanted patients were: 28 (55%) patients with syndromes with risk for sudden death, cardiomyopathy in 14 patients (27%) and congenital heart disease (CHD) in 9 patients (18%). Forty-two (82%) patients had an ICD implanted for secondary prevention after experiencing a life-threatening arrhythmia and 9 (18%) for primary prevention. An endocardial system was implanted in 39 (76%) patients and an epicardial systems in 12 (24%) patients. A total of 20 (39%) patients received appropriate shocks for ventricular fibrillation(VF). 5 patients received inappropriate shocks, 4 due to sinus tachycardia and 1 due to rapidly conducted atrial fibrillation. Those who received an inappropriate shock had a significantly shorter ICD-programmed VF detection cycle length compared to those who did not receive an inappropriate shock (320ms versus 270ms, p = 0.062). This single center study demonstrates a high rate of appropriate ICD shocks (39%) and a low rate of inappropriate ICD shocks. Accurate programming of ICD devices in the pediatric population is paramount to avoid inappropriate ICD shocks.

Progression of Device-Detected Atrial High-Rate Episodes and the Risk of All-Cause Mortality

Atrial high-rate episodes (AHREs) are prevalent in approximately 1/3 of patients with cardiac implanted electronic devices and are associated with an increased risk of several adverse outcomes. This study aimed to explore the factors associated with AHRE progression and the risk of all-cause mortality. At least 1day with AHRE burden ≥15minutes was identified in 124 of 343 recipients (36.2%) of an implantable cardioverter defibrillator or cardiac resynchronization therapy device. We included patients whose AHRE burden at the time of first detection was ≥15minutes but <24hours (n=107). Various cut-off values (15minutes, 6hours, and 24hours) of daily AHRE burden were analyzed. During an average follow-up of 4.2years, 60 patients (56.1%) experienced ≥1 progression to greater AHRE burden. Patients with hypertension or greater AHRE burden at first detection were associated with faster progression. In addition, 27 deaths (45%) occurred among 60 patients with AHRE progression, compared with 25.5% (12 of 47) for those without progression. After multivariable adjustment, AHRE progression was independently associated with all-cause mortality (hazard ratio 2.56, 95% confidence interval 1.23 to 5.35, p=0.012). Notably, AHRE progression within 1month after their first detection was associated with an increased risk for all-cause mortality (hazard ratio 4.01, 95% confidence interval 1.76 to 9.16, p=0.001) compared with patients without progression. However, a similar risk was not observed among patients with AHRE progression occurring after 1month after their first detection. In conclusion, >1/2 of the patients with AHRE progressed to a greater burden over time. Continuous monitoring of the AHRE burden may help identify patients at great risk for death.

Patients' Perspectives Regarding Generator Exchanges of Implantable Cardioverter Defibrillators.

Shared decision-making is mandated for patients receiving primary prevention implantable cardioverter defibrillators (ICDs). Less attention has been paid to generator exchange decisions, although at the time of generator exchange, patients' risk of sudden cardiac death, risk of procedural complications, quality of life, or prognosis may have changed. This study was designed to explore how patients make ICD generator exchange decisions. Emory Healthcare patients with primary prevention ICDs implanted from 2013 to 2021 were recruited to complete in-depth interviews exploring perspectives regarding generator exchanges. Interviews were conducted in 2021. Transcribed interviews were qualitatively coded using multilevel template analytic methods. To investigate benefit thresholds for pursuing generator exchanges, patients were presented standard-gamble type hypothetical scenarios where their ICD battery was depleted but their 5-year risk of sudden cardiac death at that time varied (10%, 5%, and 1%). Fifty patients were interviewed; 18 had a prior generator exchange, 16 had received ICD therapy, and 17 had improved left ventricular ejection fraction. As sudden cardiac death risk decreased from 10% to 5% to 1%, the number of participants willing to undergo a generator exchange decreased from 48 to 42 to 33, respectively. Responses suggest that doctor's recommendations are likely to substantially impact patients' decision-making. Other drivers of decision-making included past experiences with ICD therapy and device implantation, as well as risk aversion. Therapeutic inertia and misconceptions about ICD therapy were common and represent substantive barriers to effective shared decision-making in this context. Strong defaults may exist to continue therapy and exchange ICD generators. Updated risk stratification may facilitate shared decision-making and reduce generator exchanges in very low-risk patients, especially if these interventions are directed toward clinicians. Interventions targeting phenomena such as therapeutic inertia may be more impactful and warrant exploration in randomized trials.

Are we missing the beat in cancer end-of-life care: Prevalence and end-of-life monitoring of implantable cardioverter defibrillators in a population-based sample of older adults diagnosed with breast, colorectal, or pancreatic cancer.

e18728 Background: More than 50,000 implantable cardioverter defibrillators (ICDs) are placed in adults aged 65 years and older in the United States each year to manage cardiac arrhythmias. Shared risk profiles between many cancers and heart disease, as well as cardiotoxic effects of anti-cancer treatments suggest individuals with cancer are likely to have ICD devices. Although ICDs have been studied extensively in Europe, little is known about the US population, and even less is known in populations with cancer. ICDs have critical implications for end-of-life care in patients with cancer. Many patients do not include wishes for their ICD in their advanced directives, and end-of-life shocks can cause pain and distress for patients and their families. We evaluated prevalence and end-of-life monitoring of ICDs in a national sample of older adults who had breast, colorectal, or pancreatic cancer. Methods: We analyzed Surveillance, Epidemiology and End Results (SEER) data for first incident breast, colorectal, and pancreas cancer cases linked to Medicare claims (years 2004-2016) in Medicare-beneficiaries aged ³66 years. We evaluated the prevalence of ICDs by cancer stage at diagnosis with descriptive statistics. For patients with late-stage cancer (III or IV) who died in our study period we also evaluated the prevalence of ICD monitoring at the end of life. Because ICD deactivation is not a billable code, we evaluated ICD monitoring as a proxy for having an active device, hence an opportunity to discuss device deactivation. Results: In our sample of 286,015 individuals with cancer, 6.8% of patients had evidence of an ICD in their Medicare claims (6.1% breast, 8.2% colorectal, 5.3% pancreas). Of these, 49.7% had evidence of an ICD before their cancer diagnosis. The prevalence of ICDs was lower among the 60,046 individuals diagnosed with late-stage cancer( p&lt; .001) (5.0% breast, 6.1% colorectal, 4.5% pancreas). Among individuals with late-stage cancer and evidence of an ICD, 27.0% of those who died had ICD monitoring in the last six months of life (21.1% breast, 27.9% colorectal, 29.3% pancreas, p= .001), and 6.2% had monitoring in the last month of life (5.1% breast, 6.5% colorectal, 6.3% pancreas, p= .46). Conclusions: To improve the quality of care at the end-of-life for people with advanced cancer, awareness, communication, and shared decision making about ICD device management options are important considerations. These data suggest there may be opportunities to discuss prognosis and implications of advanced-stage cancer at device monitoring visits or during cardio-oncology visits.