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Background: The aim of this study was to compare differences between Polish ICD recipients and ICD recipients from other European countries in terms of quality of life, information provision before ICD implantation, and end-of-life issues., Methods: This is a sub-analysis of the "Living with an ICD" patient survey (25-item questionnaire) organized by the European Heart Rhythm Association between 12 April 2021 and 5 July 2021 in ten European countries., Results: There were 410 (22.7%) patients from Poland and 1399 (77.3%) from other European countries. A total of 51.0% of Polish patients reported improvement in their quality of life compared with 44.3% in other countries ( p = 0.041). Remote monitoring was three times more often utilized in other countries than in Poland (66.8% vs. 21.0%, p < 0.001). While 78.1% of Poles felt well informed before ICD implantation compared with 69.6% of subjects from other countries ( p = 0.001), they were less familiar with the ICD deactivation process than others (38.9% vs. 52.5%, p < 0.001)., Conclusions: Despite the less frequent use of remote monitoring and gaps in end-of-life issues, Polish ICD recipients reported more favorable quality of life and a higher level of information received before device placement than patients in other European countries.

The aim of the study was to systematically review evidence on the effectiveness and safety of oral mexiletine administered in monotherapy or in combination with other antiarrhythmic drugs for recurrent ventricular arrhythmia (ventricular tachycardia/ventricular fibrillation, VT/VF) in adult patients with structural heart disease (SHD) and implantable cardioverter defibrillators (ICDs). We systematically searched MEDLINE, Embase, and CENTRAL databases from inception to 27 August 2021 for prospective and retrospective studies investigating mexiletine in the target population. The main outcome was the reduction of ICD therapy. The main safety outcome was the presence of any serious adverse events (SAEs) leading to mexiletine discontinuation. Study quality was assessed using the Cochrane risk of bias tool or the Newcastle-Ottawa scale. Four studies comprising 86 mexiletine recipients were included in the review. We also obtained individual data of 50 patients from two studies. Ischaemic cardiomyopathy (ICM) was present in 86% of patients. The quality of included studies was moderate/low. A narrative review was undertaken as studies varied widely in terms of study population and treatment. Across studies, mexiletine treatment (with or without amiodarone) seemed to consistently reduce the number of ICD therapies especially in a population where catheter ablation (CA) was unsuccessful or contraindicated. In ICM patients deemed eligible for CA, mexiletine seemed to be inferior to CA. Mexiletine was discontinued in 14% of cases, mainly for gastrointestinal or neurological SAE. Mexiletine seems to be an option for the long-term treatment of recurrent VT/VF in adult patients with SHD, especially ICM, and ICD in whom CA was unsuccessful or not suitable., Competing Interests: Conflict of interest: None declared., (© The Author(s) 2022. Published by Oxford University Press on behalf of the European Society of Cardiology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Objectives . The aim of the study was to assess the long-term influence of catheter ablation (CA) of different arrhythmias on cardiovascular implantable electronic devices (CIED) endocardial leads durability. Design . This was a retrospective case-control study. Ablation protocols and in- or outpatient medical records were reviewed to identify and extract data on adult patients with CIED undergoing a CA. A cohort of patients with hypertrophic cardiomyopathy and implantable cardioverter-defibrillators (ICD) served as a historical control group. The primary endpoint was the diagnosis of lead damage defined as permanent loss of proper function demanding replacement or removal. Results . Among 145 patients n  = 177 catheter ablations were performed. Patients' mean age was 66.4 ± 10.5, 66.1% had an ICD or ICD with cardiac resynchronization function (CRT-D), 18.1% had >1 CA. During median 812 days [IQR 381-1588] of follow-up, there were 11 (6.2%) cases of lead damage in the examined and 13 cases (13%) in the control group, p  = 0.054. None of the technical aspects of the CA (indication, type of catheter, transseptal sheath) influenced the primary outcome. Both the number of leads and observation time after CA were significantly related to the risk of endocardial lead damage. Conclusion . This study did not find any significant influence of CA on the long-term durability of CIED endocardial leads. Reported risk factors were consistent with general population of CIED patients.

Background: Antiarrhythmic treatment of patients with recurrent ventricular tachyarrhythmia, in whom catheter ablation and amiodarone treatment were ineffective or contraindicated, is an unsolved clinical problem., Aim: The study aims to evaluate the efficacy and tolerability of mexiletine in patients with recurrent ventricular tachyarrhythmias and/or electrical storm events, in whom standard treatment strategies failed to prevent ventricular tachyarrhythmia., Methods: We performed a retrospective cohort analysis of all patients treated with mexiletine for recurrent ventricular tachycardia and/or ventricular fibrillation in our institution between January 2011 and September 2015. The primary endpoints were total number of electrical storm events and ventricular tachycardia/ventricular fibrillation (VT/VF) episodes after the beginning of mexiletine therapy. Secondary endpoints were total number of implantable cardioverter-defibrillator (ICD) therapies and discontinuation of the therapy. Events were compared with a matched duration period before initiating mexiletine. Patients served as self-controls., Results: Seventeen patients were included in the study; 11 patients were males. Mean age was 64.2 ± 15.4 years. The median time of mexiletine treatment was eight months (interquartile range [IR]: 1-22 months). The mexiletine dose was 600 mg/day in 13 patients and 400 mg/day in four patients. In four patients the dose was modified during treatment in a range from 400 to 600 mg/day depending on clinical decision. Treatment with mexiletine significantly reduced the number of electrical storm events (14 episodes vs. two episodes; median and IR for 17 patients: 1 [0-1] vs. 0 [0-0], p = 0.0010), VT/VF episodes (285 vs. 74 episodes; median and IR for 17 patients: 7 [5-27] vs. 0 [0-5], p = 0.0115), and ICD interventions (317 interven-tions vs. nine interventions; median and IR for 17 patients: 10 [5-25] vs. 0 [0-2], p = 0.0006), in comparison with a matched period before initiation of treatment. In 14 out of 17 patients (82%) sufficient tolerability of mexiletine was observed. Only in three (18%) patients severe side effects of mexiletine treatment occurred requiring discontinuation of therapy., Conclusions: Mexiletine was a sufficiently tolerated antiarrhythmic drug in short-term treatment of ventricular tachyarrhyth-mias in the studied population. Mexiletine may be effective in the treatment of recurring ventricular tachyarrhythmias or electrical storm events.

Background: Cardiovascular implantable electronic device (CIED) infection is a complication of increasing incidence. We present a protocol of an observational case control clinical trial "Positron Emission Tomography Combined With Computed Tomography (PET CT) in Suspected Cardiac Implantable Electronic Device Infection, a Pilot Study - PET Guidance I" (NCT02196753)., Aim: The aim of this observational clinical trial is to assess and standardise diagnostic algorithms for CIED infections (lead-dependent infective endocarditis, generator pocket infection, fever of unknown origin) with PET CT in Poland., Methods and Results: Study group will consist of 20 patients with initial diagnosis of CIED-related infection paired with a control group of 20 patients with implanted CIEDs, who underwent PET CT due to other non-infectious indications and have no data for infectious process in follow-up. All patients included in the study will undergo standard diagnostic pro-cess. Conventional/standard diagnostic and therapeutic process will consist of: medical interview, physical examination, laboratory tests, blood cultures; imaging studies: echocardiography: transthoracic (TTE), and, if there are no contraindications transoesophageal, computed tomography scan for pulmonary embolism if indicated; if there are abnormalities in other systems, decisions concerning further diagnostics will be made at the physician's discretion. As well as standard diagnostic procedures, patients will undergo whole body PET CT scan to localise infection or inflammation. Diagnosis and therapeutic decision will be obtained from the Study Committee. Follow-up will be held within six months with control visits at three and six months. During each follow-up visit, all patients will undergo laboratory tests, two blood cultures collected 1 h apart, and TTE. In case of actual clinical suspicion of infective endocarditis or local generator pocket infection, patients will be referred for further diagnostics. Endpoints for the results assessment - primary endpoints are to standardise PET CT in the diagnostic process: sensitivity, specificity, positive predictive value, and negative predictive value of the diagnosis made by PET CT; secondary endpoints are: assessment of usefulness of PET CT for detection of remote infective complications (metastatic abscesses, infected pulmonary emboli), incidence of particular localisations of infection, influence of PET CT on therapeutic decision: confirmation or change of decision based on PET CT, safety and complications of diagnostic process of CIED-related infections with PET CT., Conclusions: Evaluation of PET CT use for device-related infections in a case control study may be conclusive and improve diagnostic pathway.

Purpose: Effectiveness of implantable defibrillators (ICD) has been proven with large randomized trials. Unfortunately, ICD discharge is painful and potentially threatening for the patient despite its life saving effects. We analyzed influence of the clinical parameters present before implantation on the effectiveness of antitachycardia pacing therapy (ATP) in terminating ventricular tachycardia (VT) slower than 200 bpm in the coronary artery disease patients with prophylactic implanted ICD in a single centre retrospective trial., Patients/methods: We analyzed 121 consecutive coronary disease patients with ICD implanted in primary prophylaxis between 2001 and 2007, with the mean age of 62 ± 10 years. The mean follow-up was 876 ± 538 days., Results: 32 of them had VT. In 27 persons (84.4%) at least one ATP attempt terminate VT. ATP was always successful in 21 patients. We analyzed age, sex, LVEF, NYHA class, widening of QRS complex, atrial fibrillation, type of myocardial infarction or diabetes. There were no significant differences in clinical features between patients with successful and unsuccessful ATP therapy., Conclusions: High effectiveness of ATP was shown in this group. There were no clinical factors indicating success of this type of therapy. That could justify programming ATP as the first line therapy in the VT zone in primary prophylaxis coronary artery disease patients to reduce application of shock therapy. It should be possible to apply a single mode of programming when discharging patients after the implantation procedure regardless of the patient's clinical condition. This could help to control and programme the devices, thus reducing the risk of errors., (Copyright © 2014. Published by Elsevier Urban & Partner Sp. z o.o.)

We present a case report of potential reduction of hospitalization costs due to utilization of PET/CT in a diagnostic work-up of a patient with an implantable cardioverter-defibrillator and suspicion of infective endocarditis. The PET/CT scan would have shorten hospital stay, prevented clinical complications and reduced the cost of hospitalization by 45%., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Background: The increasing number of patients with cardiac implantable electronic devices (CIEDs) causes a rise in the absolute percentage of individuals qualifying for a transvenous lead extraction (TLE) due to infectious, vascular or lead failure related indications. As the survival time prolongs, TLE procedures more and more often concern the electrodes of long- -term functioning. Authors provide a retrospective analysis of the effectiveness and safety of TLE performed on leads implanted at least 10 years before the extraction., Methods: Between 2008 and 2012 we performed TLE of 364 electrodes in 217 patients. Out of these, 66 (18.1%) leads in 43 (19.8%) patients had been implanted for at least 10 years. The mean dwelling time for electrodes was 161 months (120 to 330). In 62% of cases CIED-related infection was an indication for TLE. The following extracting techniques were used: manual direct traction, device traction, mechanical telescopic sheaths, autorotational cutting sheaths and femoral approach., Results: Fifty-eight pacemakers and 8 defibrillating leads were extracted. Sixty-three (95%) completely, in the remaining 3 cases the clinical success was achieved with the small portion of the lead left into the vascular space. No major procedure complications were observed; minor complications were found in 3 (6%) patients., Conclusions: TLE with the use of various endovascular techniques is an effective and safe method for treating infectious, vascular and mechanical complications of long-lasting CIEDs therapy.

Background and Aim: Effectiveness of implantable cardioverter-defibrillators (ICD) in patients with reduced left ventricular ejection fraction after myocardial infarction has been documented in large randomised trials. We analysed the predictive value of clinical factors at the time of implantation for adequate ICD interventions and mortality risk., Methods: We analysed 121 consecutive patients (15 women, 106 [88%] men; mean age 62 ± 10 years) with coronary artery disease in whom ICD was implanted for primary prevention between 2001 and 2007. Mean duration of follow-up was 876 ± 538 days., Results: Forty-four (36.4%) patients had adequate ICD interventions. In the Cox analysis, wider QRS complexes (hazard ration [HR] per each 10 ms increment: 1.13, confidence interval [CI] 1.039-1.229, p = 0.0045) and younger age at the time of ICD implantation (HR per each 10 year increment: 0.7, CI 0.5-0.9, p = 0.0081) were associated with a higher probability of adequate intervention. Wider QRS complexes were associated with a higher probability of electrical storm (HR 1.059, CI 1.014-1.045, p = 0.0002). During follow-up, 21 (17.4%) patients died. In the Cox analysis, wider QRS complexes (HR per each 10 ms increment: 1.123, CI 1.011-1.248, p = 0.0306 [in univariate analysis only]), older age at the time of implantation (HR per each 10 year increment: 1.7, CI 1.1-2.8, p = 0.0396) and higher NYHA class (HR 4.4, CI 1.7-11.5, p = 0.0022) were associated with increased mortality. Mortality was reduced by previous revascularisation (HR 0.3, CI 0.1-0.7, p = 0.006)., Conclusions: Patients with wider QRS complexes at the time of ICD implantation had a higher probability of adequate device intervention and mortality risk. QRS complex widening was also associated with a higher incidence of electrical storm.

Background: Transvenous implantable cardioverter-defibrillators (ICD) have been implanted in Poland since 1995. As the method spreads it is important to consider its long-term benefits and disadvantages., Aim: To assess survival, efficacy and complication rate in ICD patients, who received the device more than ten years earlier., Methods: Retrospective analysis of 60 ICD patients implanted between 1995-1999., Results: There were 42 (70%) males, mean age 50.6 ± 16.4 years. In 59 patients ICD was implanted for sudden cardiac death (SCD) secondary prevention. Thirty eight patients (34 M, 63.3%) had coronary artery disease (CAD). The CAD was diagnosed in 89.5% of males and 10.5% of females (p〈 0.0001). Mean follow-up time was 75.4 ± 34.7 months. During this time 22 patients died (37%, 19 M, 3 F). Three deaths were SCD. Mean one-year mortality was 6.7%. Deaths were more frequent among males: 45.2% vs 16.7%, p〈 0.005. In CAD mortality was higher than in non-CAD patients (50% vs 13.6%, p〈 0.005). Appropriate ICD discharges in the ventricular fibrillation (VF) zone occurred in 35 (58%) patients, and in ventricular tachycardia (VT) zone - in 26 (43%) patients. Mean intervention rate per year was 3.7 for VF and 0.6 for VT. Complications occurred in 27 (45%) patients and 5 (8%) of them had no ICD intervention during follow-up. In 5 patients more than one complication was diagnosed. There were inappropriate discharges in 15 (25%) patients, 11 (18%) had electrical storm, and ICD-related infections were noted in 3 (5%) patients. During the perioperative period, lead revisions were done in 4 patients; in 3 with discharges induced by T-wave oversensing and in one with lead dislocation. Four cases of lead failure occurred during follow-up, requiring new lead implantation. In 4 patients, electrical storm (3 patients) and supraventricular tachycardia with ICD discharges (1 patient) were treated with radiofrequency ablation. Only 10 (17%) patients did not demonstrate any ICD interventions or ICD-related complications., Conclusions: 1. ICD interventions caused by malignant ventricular arrhythmias occurred in 75% patients with the device implanted more than 10 years earlier. 2. Almost a half of the analysed population suffered from complications and side effects related to implanted ICD and they were present in 8% of subjects without ICD intervention. Neither ICD interventions nor device-related adverse events were recorded in 17% of patients.

Introduction: Although implantable cardioverter-defibrillators (ICDs) are used in sudden cardiac death (SCD) prevention in high-risk patients with hypertrophic cardiomyopathy (HCM), long-term results as well as precise risk stratification are discussed in a limited number of reports. The aim of the study was to assess the incidence of ICD intervention in HCM patients with relation to clinical risk profile., Methods and Results: We studied 104 consecutive patients with HCM implanted in a single center. The mean age of study population was 35.6 (SD, 16.2) years with the average follow-up of 4.6 (SD, 2.6) years. ICD was implanted for secondary (n = 26) and primary (n = 78) prevention of SCD. In the secondary prevention group, 14 patients (53.8%) experienced at least 1 appropriate device intervention (7.9%/year). In the primary prevention (PP) group appropriate ICD discharges occurred in 13 patients (16.7%) and intervention rate was 4.0%/year. Nonsustained VT was the only predictive risk factor (RF) for an appropriate ICD intervention in the PP (positive predictive value 22%, negative predictive value 96%). No significant difference was observed in the incidence of appropriate ICD discharges between PP patients with 1, 2, or more RF. Complications of the treatment included: inappropriate shocks (33.7%), lead dysfunction (12.5%), and infections: 4.8% of patients. Four patients died during follow-up., Conclusion: ICD therapy is effective in SCD prevention in patients with HCM, although the complication rate is significant. Nonsustained ventricular tachycardia seems to be the most predictive RF for appropriate device discharges. Number of RF did not impact the incidence of appropriate ICD interventions.

We describe a case of percutaneous removal of endocardial implantable cardioverter-defibrillator lead displaced to the right pulmonary artery. The procedure was performed from two accesses; from the lower one (femoral) and then, due to technical problems, from the upper one (subclavian). In the last stage the flattened Dotter's basket was introduced to the heart inside the Byrd dilator and then fastened to the described lead as the external 'splint'. This solution is an alternative to the recommended use of the internal metal leader with anchoring function in case of significant malformation of the internal lumen of the lead. The procedure we describe is an example of the sort of individual, original solution indispensable for the efficient and safe removal of untypically displaced leads.

Aims: Having several recently published reports on increased rate of cardiac perforation with some lead models as background, we assess the relation between cardiac perforations and models of leads used., Methods and Results: All pacing and defibrillation leads implantations between 1 January 2007 and 31 March 2008 were analysed retrospectively. There were 2247 leads implanted in 1419 patients aged 67.6 +/- 14.1, 1200 (53%) active and 1047 (47%) passive fixation leads. Cardiac perforation occurred in eight patients (0.5%). The number of perforations does not differ significantly between the pacemaker and implantable cardioverter defibrillator implantations (five and three cases, respectively, P = 0.13). All perforations were associated with the active fixation leads implantation (8 vs. 0, P < 0.01). Only four models of leads were associated with perforations, but the risk of their use was not statistically significantly increased, when compared with other active fixation leads placed in the adequate position., Conclusions: The incidence of cardiac perforation related to pacing and defibrillation leads is low. The use of active fixation leads is associated with an increased risk of cardiac perforation. We did not find any correlation between the perforation rate and any particular model of the implanted lead.

Introduction: The implantation of a cardioverter-defibrillator (ICD) is an established method of sudden cardiac death (SCD) prevention. The value of ICD therapy in secondary prevention of SCD is unquestionable. Precise identification of high-risk patients and ICD use for primary prevention of SCD, especially in patients with hypertrophic cardiomyopathy (HCM), remain controversial. Problems include the high prevalence of complications associated with ICD implantation and optimal selection of ICDs., Aim: To estimate the frequency and type of complications after ICD implantations in HCM patients in a long-term follow-up., Method: The efficacy and safety of ICD therapy were estimated in 46 HCM patients with devices implanted for a secondary (n-18) or primary prevention (n-28) of SCD., Results: During the mean follow-up period of 28.2+/-26.1 months (from 2 to 68) appropriate ICD interventions occurred in 10 (55%) patients of the secondary prevention group and in 3 (10%) patients of the primary prevention group. Complications were documented in 15 (33%) patients. The most frequent were inappropriate ICD interventions recorded in 14 (30%) patients. The causes of these inappropriate ICD shocks were: T-wave oversensing (7 patients), atrial fibrillation with rapid ventricular rhythm (3 patients), lead failure (2 patients), and sinus tachycardia (2 patients). In two patients infections of the ICD pocket requiring removal of the system occurred. Displacement of the lead occurred in one patient. There were no significant differences in the prevalence of complications between the primary and secondary prevention groups or in the number of inappropriate interventions with respect to ICD type., Conclusions: The high rate of appropriate ICD shocks provides proof of high ICD-based SCD prevention efficacy. There is a high rate of complications observed after ICD implantation with inappropriate interventions being the most frequent among them. This indicates that careful programming of the device as well as the use of a programme with T-wave oversensing prevention should be ensured.