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The placement of cardiovascular implantable electronic devices (CIED) comes with a risk of adverse events (AE). AE comprise complications associated with the procedure and the device. CIED infection is a severe AE. Reported CIED infection rates are regionally differing and publications of contemporary large cohort data regarding CIED infections for Germany are lacking. This investigation provides rates of CIED infection related hospital admission and CIED infection related mortality in Germany. Data from Germany's largest healthcare insurance fund was screened for CIED procedures during the period: January to December 2015. These data included placement, revision with aim to up- or downgrade, generator substitution, early revision and partial or complete extraction using specific procedure codes for reimbursement. Among the total population of beneficiaries undergoing CIED procedures, International Classification of Diseases codes (ICD 10 GM), operational and procedural codes for partial or complete hardware removal were used to identify CIED infections and lead related endocarditis. To report the corresponding mortality rates, the hospital discharge status was documented. In 2015, from a population of more than 27 million beneficiaries, we identified the cohort of 60,296 patients (57.3% male) who underwent any invasive CIED procedure. Within three months from the index procedure, 1,595 patients developed a major CIED infection. 1,129 (1.87%) were related to the generator pocket and 466 (0.8%) were related to the transvenous proportions of the leads, mortality after those infections was 8.4% and 15.24%, respectively. In summary, our data reveals a higher prevalence of acute CIED infection than previously noted. The elevated number of additional procedures in cases of CIED infection implies a deficiency in infection awareness., Competing Interests: Declarations. Competing interests: BB currently holds or held the following positions during the last three years - medical consultant/ part of the advisory board of: Abbott, BiolineSupply, Boston Scientific, CRM Microport, CrosstecGmbH, DrugsalesLtd., Implicity, Kappamed, KimalPLC, M3 Medical/EcclipseMedical, Medival SRL, Medtronic, Philips/Spectranetics, SintecSRL, Tauro-ImplantGmbH, Tauropharm GmbH, Transcutan The other authors declare no competing interests., (© 2024. The Author(s).)

Introduction: Infection is a significant complication of cardiac implantable electronic device (CIED) therapy. The European TauroPace™ Registry investigates the safety and efficacy of TauroPace™ (TP), an antimicrobial solution containing taurolidine, designed to prevent CIED infections., Methods: This multicenter study included patients undergoing CIED procedures at participating centers where TP was used as a disinfectant for external hardware surfaces and an antiseptic for irrigating surgical sites. All patients eligible for CIED placement with adjunctive TP as the standard of care were included. Other aspects of CIED procedures adhered to current guidelines. Data on CIED-related infective endocarditis, CIED pocket infection, device and procedure-related complications, adverse events, and all-cause mortality were prospectively collected for 12 months. In cases of revision, the previous procedure was censored, and a new procedure was created. Binomial and Kaplan-Meier statistics were employed to analyze event rates., Results: From January 2020 to November 2022, TP was used in 822 out of 1170 CIED procedures. Among patients who completed the 3-month follow-up, no CIED pocket infections were observed, and one case of CIED-related infective endocarditis was reported. In the 12-month follow-up cohort, two additional local pocket CIED infections were observed, resulting in a total of three major CIED infections within 1 year after the CIED placement procedure. The 3-month and 12-month major CIED infection rates were 0.125% and 0.51%, respectively. During the observation a complication rate of 4.4% was reported. No adverse events related to TP were observed., Conclusions: TP appears to be effective and safe in preventing CIED infections., Clinicaltrials: gov Identifier: NCT04735666., (© 2024. The Author(s).)

Background: We recently described a novel pacemaker-mediated arrhythmia in Abbott cardiac implantable electronic devices (CIED), called pseudo-RNRVAS, that mimics repetitive non-reentrant ventriculoatrial synchrony (RNRVAS), but can appear in patients with ventriculoatrial (VA) block. It is caused by sinus-p-waves, trapped in the post-ventricular atrial refractory period (PVARP), which mimic VA conduction. The p-waves are followed by atrial pacing during the myocardial refractory time, which can trigger atrial fibrillation (AF). Pseudo-RNRVAS and RNRVAS are probably more common than appreciated, but the recognition and differentiation of the two can be challenging because most CIEDs do not recognize and store them., Objective: We illustrate practical challenges in the assessment of Pseudo-RNRVAS and provide programming options that proved safe and effective for preventing Pseudo-RNRVAS and reducing the risk for typical RNRVAS., Methods and Results: We illustrate in 10 patients the characteristics of Pseudo-RNRVAS and their treatment. The outcome regarding the recurrence of pseudo-RNRVAS after 6 months of follow-up was collected. Inappropriate atrial pacing during pseudo-RNRVAS resulted in AF in six patients. After shortening the PVARP in nine, inactivation/reduction of rate response in four, and reduction of the basic pacing rate in one patient, pseudo-RNRVAS was avoided in eight patients and reduced in one. In one patient AF became permanent., Conclusions: Pseudo-RNRVAS is a pacemaker-mediated arrhythmia that can appear in patients without VA conduction and may lead to AF. The suggested adjustments of pacing parameters were safe and effective in preventing the arrhythmia., (© 2023 The Authors. Pacing and Clinical Electrophysiology published by Wiley Periodicals LLC.)

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

Cardiovascular implantable electronic devices can initiate and sustain pacemaker-mediated arrhythmias. Endless loop tachycardia and repetitive non-re-entrant ventriculoatrial synchrony (RNRVAS) are well-described examples of pacemaker-mediated arrhythmias. However, such arrhythmias only occur in the presence of ventriculoatrial conduction. We identified a novel pacemaker-mediated arrhythmia that closely mimics RNRVAS but in the absence of ventriculoatrial conduction. We identified these arrhythmias in 9 patients, all with a St. Jude Medical/Abbott device, recorded as inappropriate mode-switch episodes by a device algorithm that includes paced events in the atrial counter. This report describes the mechanism, discusses clinical implications, and outlines programming options to eliminate this pseudo-RNRVAS., Competing Interests: Author Disclosures The authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Introduction: Cardiac perforation is a rare complication of cardiac implantable electronic device (CIED) implantation. Transvenous revision of perforated leads is associated with the risk of cardiac tamponade and death. Little is known about periprocedural complications and outcome of these patients., Methods and Results: All patients referred to our department with evidence or suspicion of cardiac perforation following CIED implantation underwent chest X-ray, transthoracic echocardiography, device interrogation, and, if necessary, a cardiac computed tomography (CT)-scan to diagnose lead perforation and associated complications. Transvenous lead revision (TLR) was performed in all patients with evidence of lead perforation. Patient characteristics, procedural complications, and outcome were recorded and analyzed. Fifty-six patients (75 ± 10 years, 43% male) were diagnosed with cardiac perforation, 34 patients (61%) early within 30 days post-implantation, and 22 patients (39%) thereafter. The most frequent perforation site was the right ventricular (RV) apex (75%), followed by the RV free wall (16%) and the right atrial appendage (9%). A total of 16 patients (29%) presented with severe complications; 12 patients (21%) with pericardial effusion treated by pericardiocentesis before lead revision and four patients (7%) with hematothorax requiring drainage. Late perforations showed significantly more frequent cardiac tamponades (P = .041). TLR was performed without further complications in 54 patients (96%). None of the patients required surgical treatment or experienced in-hospital death., Conclusions: Cardiac perforation following CIED implantation is associated with severe complications in nearly one-third of the cases. Transvenous revision of the perforated lead can safely be performed with a very low complication rate., (© 2020 The Authors. Pacing and Clinical Electrophysiology published by Wiley Periodicals LLC.)

The advantages of upgrade to cardiac resynchronisation therapy (CRT) have not been explored as carefully as the outcomes of de novo CRT implantations. Furthermore selection criteria for patients with the potential to benefit the most from this therapy are unknown. Therefore, we analyzed the long term outcome and its predictors in a real-world cohort receiving a CRT upgrade from previous pacemaker (PM) and defibrillator devices (ICD). We analyzed 86 patients (mean age 68 ± 9 years; 89% male) undergoing CRT upgrade procedures. Response to CRT as well as long term patient outcome was analyzed. NYHA class improved in majority of the patients during short term period (61%), and this trend remained constant during long term follow-up (54%). The observed all-cause mortality was 54% with mean survival of 49 ± 4 months. 11 patients underwent left ventricular assist device implantation or heart transplantation. In the multivariate analysis, only kidney function assessed by GFR (HR 0.97; 95% CI 0.95-0.99; p = 0.009) and LVEF (HR 0.92; 95% CI 0.87-0.97; p = 0.002) remain predictors for mortality. Patients who undergo an upgrade procedure to CRT demonstrate a significant response rate assessed by improvement in NYHA class, with initial baseline parameters such as LVEF and kidney function remaining significant predictors for mortality.

Aims: Transvenous lead extraction for cardiac implantable electronic devices (CIED) is of growing importance. Nevertheless, the optimal anaesthetic approach, general anaesthesia vs. deep sedation (DS), remains unresolved. We describe our tertiary centre experience of the feasibility and safety of DS., Methods and Results: Extraction procedures were performed in the electrophysiology (EP) laboratory by two experienced electrophysiologists. We used intravenous Fentanyl, Midazolam, and Propofol for DS. A stepwise approach with locking stylets, dilator sheaths, and mechanical sheaths via subclavian, femoral, or internal jugular venous access was utilized. Patient characteristics and procedural data were collected. Logistic regression models were used to identify parameters associated with sedation-related complications. Extraction of 476 leads (dwelling time/patient 88 ± 49 months, 30% ICD leads) was performed in 220 patients (64 ± 17 years, 80% male). Deep sedation was initiated with bolus administration of Fentanyl, Midazolam, and Propofol; mean doses 0.34 ± 0.12 μg/kg, 24.3 ± 6.8 μg/kg, and 0.26 ± 0.13 mg/kg, respectively. Deep sedation was maintained with continuous Propofol infusion (initial dose 3.7 ± 1.1 mg/kg/h; subsequently increased to 4.7 ± 1.2 mg/kg/h with 3.9 ± 2.6 adjustments) and boluses of Midazolam and Fentanyl as indicated. Sedation-related episodes of hypotension, requiring vasopressors, and hypoxia, requiring additional airway management, occurred in 25 (11.4%) and 5 (2.3%) patients, respectively. These were managed without adverse consequences. Five patients (2.3%) experienced major intraprocedural complications; there were no procedure-related deaths. All of our logistic regression models indicated intraprocedural support was associated with administration higher Fentanyl doses., Conclusion: Transvenous lead extraction under DS in the EP laboratory is a safe procedure with high success rates when performed by experienced staff., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2019. For permissions, please email: journals.permissions@oup.com.)

Aims: Proper management of post-interventional pain relieves unwarranted patient distress and enhances patient satisfaction. There have been only a limited number of investigations into patient discomfort following electrophysiological interventions. This study aims to quantify pain after interventional procedures, including ablation of atrial fibrillation (AF) or ventricular tachycardia (VT), as well as implant or explant of pacemakers or implantable cardioverter defibrillators., Methods and Results: One-hundred and two consecutive patients (mean age 66 years, 70 men) were asked to quantify post-interventional pain on a numeric rating scale (NRS 0-10) every 2 h during a period of 24 h after their intervention (49 ablations in deep propofol sedation, 53 device surgeries in local anaesthesia with mepivacaine 1%) and to specify the type of pain. Pain was classified as moderate to severe in case of NRS > 3. Post-operative pain medication included non-opioid and opioid analgesics as per the treating physicians' discretion. Sixty-one patients (60%) suffered from moderate-to-severe pain within the first 24 h after the procedure, despite the use of analgesics in 47 patients (46%). Pain was present in an early period (0-6 h) in 54% and in a late period (8-24 h) in 40% of patients. Patients complained of back pain (44%), pain at the site of the device pocket (39%), pain at the groin after puncture (7%), and pericarditic pain (5%). Multivariate analysis identified female gender (P = 0.046) associated with early post-interventional pain while age, diabetes mellitus, body mass index, type of intervention, and procedure time were not related to early or late post-interventional pain., Conclusion: The findings highlight the high prevalence and the poor predictability of moderate-to-severe post-interventional pain within the first 24 h after catheter ablation and cardiac device surgery procedures, despite the use of peri-interventional analgesics. These findings highlight the need for more careful pain assessment and management programmes., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2014. For permissions please email: journals.permissions@oup.com.)

Background: Despite modern treatment strategies, cardiogenic shock (CS) is still associated with high mortality., Objective: To evaluate the feasibility and safety of temporary percutaneous left ventricular (LV) stimulation as rescue therapy in patients with CS refractory to standard clinical care., Methods: Consecutive patients with deteriorating CS without further treatment options received transjugular placement of a temporary LV lead if they exhibited signs of asynchronous LV contraction. To maintain atrioventricular synchronous contraction, an additional right atrial lead was placed in patients with sinus rhythm. The leads were externally connected to a conventional pacemaker. Hemodynamic course, clinical outcome, and adverse events were assessed., Results: A total of 15 patients [ischemic cardiomyopathy (n = 8), dilated cardiomyopathy (n = 6), and acute myocarditis (n = 1)] underwent successful lead placement. Median procedure and fluoroscopy times measured 60 minutes (interquartile range [IQR] 55-90) and 12 minutes (IQR 7-34), respectively. Ten patients (67%) acutely responded by improvement of hemodynamic parameters with simultaneous reduction of catecholamine support. Catecholamine therapy was discontinued after a median of 28 hours (IQR 16-60). The temporary leads were removed after a median of 6 days (IQR 3-10). Total in-hospital mortality was 47%, measuring 80% in nonresponders and 30% in responders (P = .119). There was no therapy-related serious adverse event., Conclusions: Our data indicate that there may be a role for temporary LV stimulation as rescue therapy in selected patients with refractory CS. In clinical situations where aggressive therapies are used for urgent hemodynamic stabilization, temporary LV stimulation may evolve as a further and less invasive treatment option., (Copyright © 2013 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)