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Aims: During transvenous lead extraction (TLE) longer dwelling time often requires the use of powered sheaths. This study aimed to compare outcomes with the laser and powered mechanical tools.Methods and Results: Single-centre data from consecutive patients undergoing TLE between 2012 and 2021 were retrospectively analysed. Efficacy and safety of the primary extraction tool were compared. Procedures requiring crossover between powered sheaths were also analysed. Moreover, we examined the efficacy of each level of the stepwise approach. Out of 166 patients, 142 (age 65.4 ± 13.7 years) underwent TLE requiring advanced techniques with 245 leads (dwelling time 9.4 ± 6.3 years). Laser sheaths were used in 64.9%, powered mechanical sheaths in 35.1% of the procedures as primary extraction tools. Procedural success rate was 85.5% with laser and 82.5% with mechanical sheaths (P = 0.552). Minor and major complications were observed in similar rate. Procedural mortality occurred only in the laser group in the case of three patients. Crossover was needed in 19.5% after laser and in 12.8% after mechanical extractions (P = 0.187). Among crossover procedures, only clinical success favoured the secondary mechanical arm (87.1 vs. 54.5%, aOR: 0.09, 95% CI: 0.01-0.79, P = 0.030). After step-by-step efficacy analysis, procedural success was 64.9% with the first-line extraction tool, 75.1% after crossover, 84.5% with bailout femoral snare, and 91.8% by non-emergency surgery.Conclusion: The efficacy and safety of laser and mechanical sheaths were similar, however in the subgroup of crossover procedures mechanical tools had better performance regarding clinical success. Device diversity seems to help improving outcomes, especially in the most complicated cases. [ABSTRACT FROM AUTHOR]

Key Clinical Message Nonspecific symptoms such as pleuritic or pericardial chest pain in cardiovascular implantable electronic devices patients, even with unremarkable ECG or device parameters, should always raise suspicion of electrode perforation, regardless of how long ago the implantation was performed. Abstract We report the successful percutaneous management of a 77‐year‐old woman who had a dual‐chamber pacemaker implanted more than 1 year ago and presented with pericarditis pain and compensated pericardial hemorrhagic tamponade. The symptoms were due to very late acute perforation of the atrial lead. This report is intended to raise awareness of procedure‐related complications in the large group of cardiovascular implantable electronic device patients. Pleuritic or pericardial pain in these patients should raise suspicion of electrode perforation, as the risk of perforation is not restricted to the period immediately after implantation and a lifelong risk cannot apparently be excluded.

IntroductionRemote monitoring (RM) technologies have the potential to improve patient care by increasing compliance, providing early indications of heart failure (HF), and potentially allowing for therapy optimization to prevent HF admissions. The aim of this retrospective study was to assess the clinical and economic consequences of RM vs. standard monitoring (SM) through in-office cardiology visits, in patients carrying a cardiac implantable electronic device (CIED).MethodsClinical and resource consumption data were extracted from the Electrophysiology Registry of the Trento Cardiology Unit, which has been systemically collecting patient information from January 2011 to February 2022. From a clinical standpoint, survival analysis was conducted, and incidence of cardiovascular (CV) related hospitalizations was measured. From an economic standpoint, direct costs of RM and SM were collected to compare the cost per treated patient over a 2-year time horizon. Propensity score matching (PSM) was used to reduce the effect of confounding biases and the unbalance of patient characteristics at baseline.ResultsIn the enrollment period, N = 402 CIED patients met the inclusion criteria and were included in the analysis (N = 189 patients followed through SM; N = 213 patients followed through RM). After PSM, comparison was limited to N = 191 patients in each arm. After 2-years follow-up since CIED implantation, mortality rate for any cause was 1.6% in the RM group and 19.9% in the SM group (log-rank test, p

Unlimited access to ECGs using an over-the-counter smartwatch constitutes a real revolution for our discipline, and the application is rapidly expanding to include patients with cardiac implantable electronic devices (CIEDs) such as pacemakers (PMs) and implantable cardioverter defibrillators (ICDs). CIEDs require periodic evaluation and adjustment by healthcare professionals. In addition, implanted patients often present with symptoms that may be related to their PMs or ICDs. An ECG smartwatch could reveal information about device functioning, confirm normal device function, or aid in the case of device troubleshooting. In this review, we delve into the available evidence surrounding smartwatches with ECG registration and their integration into the care of patients with implanted pacemakers and ICDs. We explore safety considerations and the benefits and limitations associated with these wearables, drawing on relevant studies and case series from our own experience. By analyzing the current landscape of this emerging technology, we aim to provide a comprehensive overview that facilitates informed decision-making for both healthcare professionals and patients.

The article explores the impact of cardiac implantable electronic devices (CIEDs) on tricuspid regurgitation (TR) and discusses the challenges in management. Topics discussed include the pathophysiologic mechanisms of CIED-associated TR, imaging methods for assessing TR with a focus on three-dimensional transesophageal echocardiography (3DTEE), and the role of different pacing strategies in mitigating TR severity.

The Polish Cardiac Society is celebrating its 70th anniversary this year. Since its establishment in 1950, the society has played a significant role in the development of cardiology in Poland, shaping cardiac thought, initiating new research directions, and creating innovative therapeutic procedures. The society organizes annual congresses and conferences to disseminate modern knowledge and improve patient care. It currently has about 5,300 members and publishes the scientific journal Polish Heart Journal. The society is involved in various initiatives, including programs for managing myocardial infarction and lipid disorders, as well as advocating for the inclusion of cardiology services in healthcare reimbursement. They also collaborate with patient organizations and participate in national programs for cardiovascular diseases. [Extracted from the article]

The feasibility and effectiveness of virtual visits (VVs) for cardiac electrophysiology patients are still unknown. We aimed to assess the feasibility and effectiveness of VVs as compared to in-person visits, and to describe patient experience with virtual care in clinical electrophysiology. We prospectively enrolled patients scheduled to receive a clinical electrophysiology evaluation, dividing them in two groups: a VV group and an in-person visit group. Outcomes of interest were: (1) improvement in symptoms after the index visit, (2) disappearance of remote monitoring (RM) alerts at follow-up, (3) necessity of urgent hospitalization and (4) patient satisfaction measured by the Patient Satisfaction Questionnaire-18 (PSQ-18). This study included 162 patients in the VV group and 185 in the in-office visit group. As compared to in-person visits, VVs resulted in a similar reduction in RM alerts (51.5% vs. 43.2%, p-value 0.527) and in symptomatic patient rates (73.6% vs. 56.9%, p-value 0.073) at follow-up, without differences in urgent hospitalization rates (p-value 0.849). Patient satisfaction with VVs was higher than with in-person evaluation (p-value < 0.012). VVs proved to be as feasible and as effective as in-person visits, with high patient satisfaction. A hybrid model of care including VVs and in-person visits may become the new standard of care after the COVID-19 pandemic is over. [ABSTRACT FROM AUTHOR]

Aims Cardiac implantable electronic device (CIED) infection is a severe complication to modern management of cardiac arrhythmias. The CIED type and the type of surgery are recognized as risk factors for CIED infections, but knowledge of patient-related risk factors is scarce. This study aimed to identify lifelong patient-related risk factors for CIED infections. Methods and results Consecutive Danish patients undergoing a CIED implantation or reoperation between January 1996 and April 2018 were included. The cohort consisted of 84 429 patients undergoing 108 494 CIED surgeries with a combined follow-up of 458 257 CIED-years. A total of 1556 CIED explantations were classified as either pocket (n = 1022) or systemic CIED infection (n = 534). Data were cross-linked with records from the Danish National Patient Registry and the Danish National Prescription Registry. Using multiple-record and multiple-event per subject proportional hazard analysis, specific patient-related risk factors were identified but with several variations amongst the subtypes of CIED infection. CIED reoperations were associated with the highest risk of pocket CIED infection but also CIED type, young age, and prior valvular surgery [hazard ratio (HR): 1.62, 95% confidence interval (CI): 1.29–2.04]. Severe renal insufficiency/dialysis (HR: 2.40, 95% CI: 1.65–3.49), dermatitis (HR: 2.80, 95% CI: 1.92–4.05), and prior valvular surgery (HR: 2.09, 95% CI: 1.59–2.75) were associated with the highest risk of systemic CIED infections. Congestive heart failure, ischaemic heart disease, malignancy, chronic obstructive pulmonary disease, and temporary pacing were not significant at multivariate analysis. Conclusion Specific comorbidities and surgical procedures were associated with a higher risk of CIED infections but with variations amongst pocket and systemic CIED infection. Pocket CIED infections were associated with CIED reoperations, young age and more complex type of CIED, whereas systemic CIED infections were associated with risk factors predisposing to bacteraemia. [ABSTRACT FROM AUTHOR]

Infections are important complications of cardiac implantable electronic devices (CIED), with a high prognostic impact. Several risk factors for CIED infections are known. Different studies have been published proposing different risk scores, in order to preoperatively assess the individual likelihood of developing a CIED infection. Among the different scores, large heterogeneity exists and there is no consensus or convergence on a single score finding large applicability in global practice. The aim of this review is to comprehensively present and analyze all the available risk scores for CIED infection, with particular regard to the evidence of comparison studies. [ABSTRACT FROM AUTHOR]

One of the most concerning adverse events related to the SARS-CoV-2 vaccination is arrhythmia. To ascertain the relationship between vaccination and arrhythmic events, we studied the occurrence of arrhythmia in patients with cardiac implantable electronic devices (CIEDs) before and after a SARS-CoV-2 vaccination. Patients with CIEDs aged ≥18 who visited the CIED clinic at King Chulalongkorn Memorial Hospital and Vajira hospital from August 2021 to February 2022 were included. Information about the SARS-CoV-2 vaccination and side effects was obtained. One hundred eighty patients were included in our study, which compared the incidence of arrhythmias in the 14 days post-vaccination to the 14 days before vaccination. The median age was 70 years. The number of patients who received one, two, and three doses of the vaccine was 180, 88, and 4, respectively. ChAdOx1 was the primary vaccine used in our institutes, accounting for 86% of vaccinations. The vaccination was significantly associated with a 73% increase incidence of supraventricular tachycardia (SVT). In an adjusted model, factors associated with the incidence of SVT were the post-vaccination period, female sex, increasing BMI, chronic kidney disease, and a history of atrial fibrillation. Increased ventricular arrhythmia (VA) episodes were also associated with the post-vaccination period, female sex, decreasing BMI, and chronic kidney disease, but to a lesser degree than those with SVT episodes. No life-threatening arrhythmia was noted in this study. In conclusion, the incidence of arrhythmia in patients implanted with CIEDs was significantly increased after the SARS-CoV-2 vaccination. [ABSTRACT FROM AUTHOR]

[Display omitted] • We synthesized peptidomimetic FK-13 for cardiac implantable electronic devices pocket infections. • Our composite hydrogel possessed satisfactory sustained release effect on FK-13. • The PN-FK hydrogel exhibited broad-spectrum antibacterial capacity. • PN-FK coated CIED surfaces enhanced anti-infection and tissue regeneration capabilities in vivo. • The transcriptomic analysis revealed the cellular mechanisms and pathways influenced by PN-FK. Elderly patients predispose to cardiovascular implantable electronic devices (CIEDs) pocket infections due to multiple comorbidities. Treating infections with the antibiotics further carry higher risks for complications, and surgical intervention can be costly when device removal and reimplantation are required, both emphasizing the importance of novel preventive strategies to minimize the incidence of pocket infections. To meet the unique needs for elderly, we constructed an CIED surface modified hydrogel which crosslinked polyethylene glycol diacrylate (PEGDA) with hyaluronic acid-nitrobenzene (HN) to form the polymeric structures that mimic the natural environment for promoting "Pocket" surrounding tissue integration and healing. Importantly, we synthesized the new peptidomimetics FK-13 derived by shortening amino acid sequence of LL-37 which is the only human cathelicidin-derived antimicrobial peptide. By incorporating FK-13 with initial PN hydrogel via Schiff base formation, the created PN-FK hydrogel exhibited broad-spectrum antimicrobial activity against bacteria with excellent biocompatibility and mechanical properties in a long-term release manner. In an in vitro setting, PN-FK hydrogel demonstrated the regeneration capacity by expression of Hmox1, Col5 and Col6 associated genes in fibroblasts as well as expression of Gpx1, Cdc20 and MMP9 genes in stem cells to accelerate self-renewal, collagen secretion and reconstitution of matrix components. In the following in vivo model of subcutaneous implantation, CIED-shape titanium mesh with surface modification by PN-FK hydrogel efficiently subsided over-inflammation compared to bare titanium implant, and expedited collagen deposition and angiogenesis in peri -pocket tissues within 2 weeks. These findings underscore the potential of the PN-FK hydrogel as a transformative approach to CIED postoperative management, offering a dual-action solution that combines infection resistance with tissue regeneration capabilities. [ABSTRACT FROM AUTHOR]

Introduction: Magnetic interaction of portable electronic devices (PEDs), such as state-of-the art mobile phones, with cardiovascular implantable electronic devices (CIEDs) has been reported. The aim of the study was to quantify the magnetic fields of latest generation smartwatches and other PEDs and to evaluate and predict their risk of CIED interactions. Methods: High resolution magnetic field characterization of five smartwatches (Apple Watch 6/7, Fitbit Sense, Samsung Galaxy 3, Withings Scanwatch) was performed using a novel magnetic field camera. Ex vivo measurements of the minimal safety distance (MSD) at which no mode switch can be observed were performed between 11 PEDs and six representative CIEDs. Results: Maximal 1 mT distances ranged between 10 mm (Withings) and 19 mm (Fitbit and AppleWatch), and 1 mT volumes between 6 cm3 (Withings) and 19 cm3 (Fitbit). All these measures were observed only for the back side of the smartwatches. While most smartwatches with measured 1 mT distance 15 mm showed device interaction up to > 15 mm. Linear regression analysis showed a linear relationship of the MSD with 1 mT distance (B coefficient: 0.46; 95 %-CI: 0.25–0.67, p

Summary: Background: Cardiac implantable electronic devices (CIED) have become an indispensable part in everyday clinical practice in cardiology. The indications for CIED implantation are based on the guidelines of the European Heart Rhythm Association (EHRA). Nevertheless, numbers of CIED implantations in Europe are subject to considerable differences. We hypothesized that reimbursements linked to the respective health systems may influence implantation behavior. Methods: Based on the EHRA White Book 2017, CIED implantation data as well as socioeconomic key figures were collected, in particular gross domestic product (GDP) and share of gross domestic product spent on healthcare. Implantation numbers for pacemakers, implantable cardioverter defibrillators and cardiac resynchronization treatment as well as all in total were assessed, compared with the health care expenditures and visualized using heat maps. Results: Total implantation numbers per 100,000 inhabitants varied from 196.53 (Germany) to 2.81 (Kosovo). Higher implantation numbers correlated moderately with a higher GDP (r = 0.456, p 0.002) and higher health expenditure (r = 0.586, p < 0.001). The annual financial resources per inhabitant were also subject to fluctuations ranging from 9476 $ (Switzerland) to 140 $ (Ukraine); however, there were countries with high financial means, such as Switzerland or Scandinavian countries, which showed significantly lower implantation rates. Conclusion: There were considerable differences in CIED implantations in Europe. These seem to be explained in part by socioeconomic disparities within Europe. Also, a potential influence by the respective remuneration system is likely. [ABSTRACT FROM AUTHOR]

Background: There is insufficient evidence regarding postoperative systemic antibiotic prophylaxis use for more than 24 h following cardiovascular implantable electronic devices (CIED) implantation and its impact on infection prevention. However, this strategy remains a common practice in many institutions. Methods: We conducted a systematic review and meta‐analysis including studies that compared the outcomes of patients: (1) who received preoperative plus 24 h or more of postoperative antibiotic prophylaxis (intervention group); and (2) who received either preoperative only or preoperative plus less than 24 h of antibiotic prophylaxis (control group). Risk of bias was assessed with ROBINS‐I and ROB‐2 tools. Risk ratio (RR) was pooled using random‐effect meta‐analyses with inverse variance method. Results: Eight studies that included two randomized controlled trials (RCTs) and six cohort studies with a total of 26,187 patients were included in the analysis. Overall, there were no differences in outcomes between the two groups, which included rates of CIED infection (RR 0.77, 95% CI 0.42, 1.42), mortality (RR 1.19, 95% CI 0.69, 2.06), pocket hematoma (RR 1.15, 95% CI 0.44, 3.00) or reintervention (RR 0.87, 95% CI 0.22, 3.46). Of note, the results were primarily impacted by the larger RCT. Conclusions: There was no benefit of postoperative antibiotic prophylaxis for more than 24 h following CIED implantation in the current systematic review and meta‐analysis. This supports the practice advocated by current guidelines which foster antibiotic stewardship and may result in reductions of adverse drug events, selection for antibiotic resistance, and financial costs of prolonged postoperative antibiotic prophylaxis. [ABSTRACT FROM AUTHOR]

Cardiac implantable electronic devices (CIEDs) are essential for the management of a variety of cardiac conditions, including tachyarrhythmias, bradyarrhythmias, and medically refractory heart failure (HF). Recent advancements in CIED technology have led to innovative solutions that overcome shortcomings associated with traditional devices or address unmet needs. Leadless pacemakers, subcutaneous implantable cardioverter defibrillators (ICDs), and extravascular ICDs eliminate lead-related complications common with conventional pacemakers or ICDs. Conduction system pacing (His bundle pacing and left bundle branch pacing) is a more physiologic method of pacing and avoids the deleterious consequences associated with long-term right ventricular pacing. For HF-related devices, cardiac contractility modulation is an emerging therapy that bridges a gap for many patients ineligible for cardiac resynchronization therapy and has been shown to improve HF symptoms and decrease hospitalizations and mortality in select patients. Implantable pulmonary artery pressure monitors help guide HF management and reduce hospitalizations. Lastly, new phrenic nerve stimulating devices are being utilized to treat central sleep apnea, a common comorbidity associated with HF. While further long-term studies are still underway for many of these new technologies, it is anticipated that these devices will become indispensable therapeutics in the expanding cardiovascular armamentarium. [ABSTRACT FROM AUTHOR]

A large proportion of patients referred for transcatheter tricuspid valve intervention (TTVI) will have the presence of a cardiac implantable electronic device (CIED). In such patients, surgical correction of tricuspid regurgitation (TR) is associated with high rates of morbidity and mortality. Transvenous lead extraction (TLE) could potentially ameliorate CIED-induced TR; however, it carries inherent risks and frequently does not result in TR improvement. As multiple TTVI devices are in trial to gain regulatory approval, understanding which therapy is most appropriate among patients with a CIED is essential. This review centers on the nonsurgical treatment, including TLE and transcatheter tricuspid valve repair and replacement options, aimed at enhancing outcomes in patients with TR who also have concurrent CIEDs., (© 2024 Wiley Periodicals LLC.)

Aims: Cardiac implantable electrical devices such as cardiac resynchronization therapy with defibrillator (CRT-Ds) or cardiac contractility modulation (CCMs) are therapy options for patients with symptomatic heart failure (HF) and reduced left ventricular ejection fraction (LVEF) despite optimal medical treatment. As yet, a comparison between both devices has not been performed., Methods and Results: The Mannheim Cardiac Resynchronization Therapy Registry (MARACANA) and the Mannheim Cardiac Contractility Modulation Observational Study (MAINTAINED) included all patients who received CRTs or CCMs in our medical centre between 2012 and 2021. For the present analysis, we retrospectively compared patients provided with either CRT-Ds (n = 220) or CCMs with additional defibrillators (n = 105) regarding New York Heart Association classification (NYHA), LVEF, tricuspid annular plane systolic excursion (TAPSE), QRS-width and other HF modification aspects after 12 months. Before implantation, CCM patients presented with lower LVEF (23.6 ± 6.2 vs. 26.3 ± 6.5%) and worse NYHA (3.03 ± 0.47 vs. 2.81 ± 0.48, both P < 0.05), compared with CRT-D patients. Follow-up improvements in NYHA (2.43 ± 0.67 vs. 2.28 ± 0.72), LVEF (30.5 ± 10.7 vs. 35.2 ± 10.5%) and TAPSE (17.2 ± 5.2 vs. 17.1 ± 4.8 to 18.9 ± 3.4 vs. 17.3 ± 3.6 mm, each P < 0.05) were comparable. The intrinsic QRS-width was stable with CCM (109.1 ± 18 vs. 111.7 ± 19.7 ms, P > 0.05), while the paced QRS-width with CRT-D after 12 months was lower than intrinsic values at baseline (157.5 ± 16.5 vs. 139.2 ± 16 ms, P < 0.05). HF hospitalizations occurred more often for CCM than CRT-D patients (45.7 vs. 16.8%/patient years, odds ratio 4.2, P < 0.001)., Conclusions: Chronic heart failure patients could experience comparable 12-month improvements in functional status and ventricular reverse remodelling, with appropriately implanted CCMs and CRT-Ds. Differences in HF hospitalization rates may be due to the more advanced HF of CCM patients at implantation., (© 2024 The Author(s). ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

OBJECTIVE: Implantation or replacement of a cardiovascular implantable electronic device (CIED) may be associated with complications, such as pocket hematomas and infections. This study aims to determine whether a lyophilized gentamycin-containing collagen implant (GCCI) reduces major CIED infections and pocket hematomas after implant. SUBJECTS AND METHODS: A retrospective study was conducted among patients who underwent implantation or replacement of CIED at the Tor Vergata Polyclinic (Rome, Italy) between June 2007 and November 2019. The primary combined endpoint was infection and hematoma occurrence through 12 months of follow-up post-procedure. The rate of single infectious complications, pocket hematomas or both were also assessed. RESULTS: We compared 475 patients treated with the GCCI (GCCI group) with 714 patients who did not receive it (control group). Complications occurred in 127 patients (11%); a statistically significant reduction of infections and pocket hematomas in the GCCI group was reported when compared with control patients (1% vs. 17%; p<0.0001). A total of 20 (2%) infectious events were reported, 102 (8%) patients developed a pocket hematoma, and 5 (0.4%) had both. The rate of single complications was significantly lower in GCCI group: infection 0.2% vs. 2.6% (p=0.002), pocket hematoma 0.6% vs. 13.8% (p<0.001). The association between antiplatelet/anticoagulation therapy and hematoma development was not statistically significant. CONCLUSIONS: The GCCI is a medical device that can be used in addition to local hemostasis and prophylactic doses of systemic antibiotics with the aim of reducing infective complications and pocket hematoma after permanent CIED implantation or replacement. [ABSTRACT FROM AUTHOR]

Background The implantation of cardiac implantable electronic devices is a globally established therapy to treat cardiac arrhythmias with low complication rates. Apart from technical problems, however, complications can arise from the implanted material. This can lead to bleeding, infections, or chronic irritation of the generator pocket, resulting in swellings, seromas, perforations, or fistulas. However, the cause of tissue changes is not always clear, and therefore, we would like to report on a rare tissue degeneration diagnosed in a patient. Case summary After a history of ventricular fibrillation, a 46-year-old patient received an implantable cardioverter-defibrillator (ICD) for secondary prevention. Six years later, the generator pocket swelled without evidence of infection. With the suspected diagnosis of a chronically irritated pocket, the device was then surgically relocated. After a 2-year symptom-free period, the patient presented again with a severely swollen but only slightly painful device pocket. Once again, there were no signs of infection, and so the pocket was revised again, assuming a chronic irritant effusion. Intraoperatively, a lipomatous structure (12 × 6 × 3 cm) emerged from the subpectoral ICD pocket. After its complete removal, the histopathological examination revealed a lipoma. A bacterial genesis could be ruled out by microbiological samples, and the wound healed cosmetically well and without further discomfort. Conclusion This case shows that the reason of chronically irritated generator pockets, in addition to the usually known tissue changes, can also be tumours. Therefore, resected tissue should be examined histopathologically and, if indicated, specific therapy initiated. [ABSTRACT FROM AUTHOR]

Cardiac Implantable Electronic Device (CIED) infections pose significant mortality and morbidity despite optimal treatment. This survey aimed to understand whether and how the risk of CIED infection is assessed and mitigated in clinical practice in Europe, and to detect gaps with respect to EHRA recommendations. An Expert Group of 8 European cardiologists with specific expertise across CIED therapy designed and distributed electronically a survey to a number of European Cardiologists. 302 physicians from 18 European countries responded to the survey. 288/302 (95%) physicians agreed that CIED-related infections represent a burden on healthcare resources and are associated with significant morbidity and mortality. 285/302 respondents (94%) primarily assess the risk of CIED infections by only evaluating the patient's clinical profile (137/302, 46%) or with the support of a risk score (148/302, 49%). Intravenous antibiotic prophylaxis is used by 282/302 (93%), followed by the implantation of the lowest number of leads possible (182/302, 60%), and by the use of an antibacterial envelope (173/302, 57%). 230/302 respondents (76%) declared that there is need for clear and concise guidelines and more sensitive risk-scores for CIED infection, to maximize the chances of preventative strategies. This survey demonstrates a high level of awareness about the multifaceted issue of CIED infection, however, it also highlights an incomplete penetration of scoring systems for risk stratification owing to their perceived limitations, and detects a strong commitment to increase the effectiveness of preventative strategies. [Display omitted] • Awareness towards CIED infection and preventative strategies are recorded across all European countries. • Risk scores to predict CIED infection are perceived as limited, and confidence with them is incomplete. • Simpler and more sensitive tools for risk assessment represent an unmet need. Education campaigns are desirable. [ABSTRACT FROM AUTHOR]

Background & Aims: Early identification of worsening HF enables timely adjustments to prevent hospitalization. Recent studies show the HeartLogic™ algorithm detects congestion and reduces HF events. However, it is unclear which patients benefit most. Therefore, this study aims to identify and characterize HF patients who benefit most from CIED-based remote monitoring with HeartLogic™. Methods: In this multicenter retrospective study, patients with a CIED and HeartLogic™ algorithm under structured follow-up were included. Patients were classified as having "substantial benefit" or "no benefit" from monitoring. Results: In total, 242 patients were included (male n = 190, 79%, median age 61 years [IQR 61–77]). Median follow-up was 1.2 years [IQR 1.1–2.7]. Among 378 alerts, 266 were true positive (70%) and 112 false positive (30%). Of the 242 patients, 69 (29%) were classified as having "substantial benefit", while 173 (71%) had "no benefit" from HeartLogic™ monitoring. Univariate and multivariate analysis showed that patients with "substantial benefit" had higher NYHA functional class (OR 2.64, P = 0.004), higher NT-ProBNP (OR 1.02, P = 0.003), higher serum creatinine (OR 1.10, P < 0.001), lower LVEF (OR 1.19, P = 0.004), more severe mitral regurgitation (OR 2.16, P = 0.006), higher right ventricular end diastolic volume (OR 1.05, P = 0.040), higher pulmonary artery pressures (OR 1.19, P = 0.003), and were more likely to use loop diuretics (OR 2.79, P = 0.001). Among patients with "substantial benefit," the positive predictive value (PPV) of HeartLogic™ to detect congestion was 92%. Conclusion: The utilization of CIED-based HeartLogic™ driven HF care demonstrated pronounced efficacy, predominantly in patients exhibiting characteristics of HF at a more advanced disease stage. Graphical abstract [Display omitted] • HeartLogicTM algorithm detects impending fluid retention in heart failure patients with CIED. • Heart failure patients with more advanced disease are likely to benefit more from the HeartLogicTM algorithm. • HeartLogicTM was useful in about one third of the patients analyzed and a patient centered approach is needed to selectively monitor those patients who are likely to benefit most. [ABSTRACT FROM AUTHOR]

AimEarly detection of impending fluid retention and timely adjustment of (medical) therapy can prevent heart failure related hospitalizations. The multisensory cardiac implantable electronic device (CIED) based algorithm HeartLogicTM aims to alert in case of impending fluid retention. The aim of the current analysis is to evaluate the performance of the HeartLogicTM guided heart failure care path in a real-world heart failure population and to investigate whether the height of the index and the duration of the alert state are indicative of the degree of fluid retention.MethodsConsecutive adult heart failure patients with a CIED and an activated HeartLogicTM algorithm were eligible for inclusion. Patients were followed up according to the hospital's heart failure care path. The device technician reviewed alerts for a technical CIED checkup. Afterwards, the heart failure nurse contacted the patient to identify impending fluid retention. An alert was either true positive or false positive. Without an alert a patient was true negative or false negative.ResultsAmong 107 patients, [82 male, 70 (IQR 60–77) years, left ventricular ejection fraction 37 ± 11%] 130 HeartLogicTM alerts were available for analysis. Median follow up was 14 months [IQR 8–23]. The sensitivity to detect impending fluid retention was 79%, the specificity 88%. The positive predictive was value 71% and the negative predictive value 91%. The unexplained alert rate was 0.23 alerts/patient year and the false negative rate 0.17 alerts/patient year. True positive alerts [42 days (IQR 28–63)] lasted longer than false positive alerts [28 days (IQR 21–44)], p = 0.02. The maximal HeartLogicTM index was higher in true positive alerts [26 (IQR 21–34)] compared to false positive alerts [19 (IQR 17–24)], p < 0.01. Patients with higher HeartLogicTM indexes required more intense treatment (index height in outpatient setting 25 [IQR 20–32], day clinic treatment 28 [IQR 24–36] and hospitalized patients 45 [IQR 35–58], respectively), p < 0.01.ConclusionThe CIED-based HeartLogicTM algorithm facilitates early detection of impending fluid retention and thereby enables clinical action to prevent this at early stage. The current analysis illustrates that higher and persistent alerts are indicative for true positive alerts and higher index values are indicative for more severe fluid retention.

Axillary vein puncture (AVP) is a valid alternative to Subclavan vein puncture for leads insertion in cardiac implantable electronic device implantation, that may reduce acute and delayed complications. Very few data are available about ICD recipients. A simplified AVP technique is described. All the patients who consecutively underwent "de novo" ICD implantation, from March 2006 to December 2020 at the University of Verona, were considered. Leads insertion was routinely performed through an AVP, according to a simplified technique. Outcome and complications have been retrospectively analyzed. The study population consisted of 1711 consecutive patients. Out of 1711 patients, 38 (2.2%) were excluded because they were implanted with Medtronic Sprint Fidelis lead. Out of 1673 ICD implantations, 963 (57.6%) were ICD plus cardiac resynchronization therapy, 434 (25.9%) were dual-chamber defibrillators, and 276 (16.5%) were single-chamber defibrillators, for a total of 3879 implanted leads. The AVP success rate was 99.4%. Acute complications occurred in 7/1673 (0.42%) patients. Lead failure (LF) occurred in 20/1673 (1.19%) patients. Comparing the group of patients with lead failure with the group without LF, the presence of three leads inside the vein was significantly associated with LF, and the multivariate analysis confirmed three leads in place as an independent predictor of LF. AVP, according to our simplified technique, is safe, effective, has a high success rate, and a very low complication rate. The incidence of LF was exceptionally low. The advantages of AVP are maintained over time in a population of ICD recipients. • Axillary vein puncture is safe and effective for CIED implantation. • Simplified axillary vein puncture introduces some technical details that contributes to simplify the vein access. • The study population is a unique cohort of patients composed of ICD recipients. • The study provides a long follow-up and lead survival analysis. [ABSTRACT FROM AUTHOR]

Simple Summary: According to our analysis of the multicenter EORP ELECTRa (European Lead Extraction ConTRolled) Registry, about one-third of the candidates to complete removal of an implantable pacemaker/defibrillator because of device infection, through standard transvenous lead extraction, presents a systemic infection. Systemic infection is associated with a higher incidence of major in-hospital complications overall and a strong trend for procedure-related complications. Moreover, systemic infection is associated with increased procedure-related and non-procedure-related in-hospital mortality. Patients with cardiac implantable devices (CIED)-related infection with systemic vs. local involvement present different characteristics suggesting that in a relevant subgroup of patients the infection can be systemic from the beginning, without progression from CIED pocket. Background: Infections of cardiac implantable devices (CIEDI) have poor outcomes despite improvement in lead extraction (TLE) procedures. Methods: To explore the influence of CIEDI on the outcomes of TLE and the differences between patients with systemic (Sy) vs. local (Lo) CIEDI, we performed a sub-analysis of the EORP ELECTRa (European Lead Extraction ConTRolled) Registry. Results: Among 3555 patients enrolled by 73 centers in 19 Countries, the indication for TLE was CIEDI in 1850: 1170 with Lo-CIEDI and 680 with Sy-CIEDI. Patients with CIEDI had a worse in-hospital prognosis in terms of major complications (3.57% vs. 1.71%; p = 0.0007) and mortality (2.27% vs. 0.49%; p < 0.0001). Sy-CIEDI was an independent predictor of in-hospital death (H.R. 2.14; 95%CI 1.06–4.33. p = 0.0345). Patients with Sy-CIEDI more frequently had an initial CIED implant and a higher prevalence of comorbidities, while subjects with Lo-CIEDI had a higher prevalence of previous CIED procedures. Time from signs of CIEDI and TLE was longer for Lo-CIEDI despite a shorter pre-TLE antibiotic treatment. Conclusions: Patients with CIEDI have a worse in-hospital prognosis after TLE, especially for patients with Sy-CIEDI. These results raise the suspicion that in a relevant group of patients CIEDI can be systemic from the beginning without progression from Lo-CIEDI. Future research is needed to characterize this subgroup of patients. [ABSTRACT FROM AUTHOR]

During the coronavirus disease 2019 (COVID-19) worldwide pandemic, patients with cardiac implantable electronic device (CIED) refused scheduled follow-up visits because of the risk of infection. In this scenario, different telemedicine strategies have been implemented to ensure continuity of care to CIED patients. Patients can be monitored through dedicated applications, telephone calls, or virtual visits providing easy access to valuable information, such as arrhythmic events, acute decompensation manifestations, and device-related issues, without the need for in-person visits. This review provides a comprehensive description of the many possible applications of telemedicine for CIED patients during the COVID-19 period. [ABSTRACT FROM AUTHOR]

The subcutaneous implantable cardioverter defibrillator (S-ICD) is currently in its third generation and has been adopted in guidelines and in mainstream clinical practice. Considerable improvements have been made since the introduction of this device over a decade ago. A literature search was undertaken in Pubmed on articles relating to the S-ICD. The therapy has been proven to be safe and effective and is a valuable option in selected patients. Nevertheless, there remain many shortcomings of the S-ICD which are discussed in this review, and which hopefully will be addressed by future generations of the device. [ABSTRACT FROM AUTHOR]

Background: Goa is the smallest state in India with a native population of 15 lakhs and floating population of another 15 lakhs. There are no studies done on the patients who undergo procedures for cardiovascular implantable electronic device (CIED). Objective: Aim of our study is to find out the indications for device implantation, demographics, the rate, and type of complications post CIED implant in this population. Method: It is a descriptive observational study of patients who underwent CIED implantation procedure. Result: Of the 120 patients, 58.33% were males and 41.67% were females. Median age of study population was 70 years. 78.33% patients underwent CIED for atrio-ventricular (AV) block. Dual chamber pacemaker (DDD) and single-chamber ventricular pacemaker (VVI) were commonly used CIEDs. 20.83% patients experienced complications from CIED. Conclusion: As per our study, the commonest indication for CIED in our study population was an Atrioventricular block (AV block). Third degreeAV block consisted 62.50% of all patients. Male patients more often receive CIED than females. Use of DDI and VVI implant was more and equal at our centre. 20.83% patients experienced complications of CIED. Pneumothorax and infections were major complications of CIED in our study population. [ABSTRACT FROM AUTHOR]

Introduction: Cardiac implantable electronic devices (CIED) such as pacemakers or cardioverter defibrillators prevent dangerous heart arrhythmias and conduction abnormalities. Post-intervention education is crucial in the patient recovery process and aims to avoid both dangerous behavior and unnecessary restraints in daily living. Objective: The evaluation of knowledge of daily activities' safety among patients with CIEDs and an analysis of the relationship between the state of knowledge and perceived post-intervention quality of life. Materials and Methods: The study group included 100 patients (57% men) with CIEDs, recruited in the University Hospital in Kraków. Data on the patients' knowledge about permissible daily activities, medical procedures and perceived quality of life was collected using a dedicated questionnaire, which comprised 57 simple and multiple-choice questions. Results: The analyzed group included patients aged 28 to 97 years (mean age 73). Among them, 26% either have not received or have not read the information booklet. Two-thirds of them either need more information about their device (51%) or do not possess essential knowledge (15%). Patients raised concerns about performing daily activities such as: car-driving (38%), using seat belts (14%), bathing (15%), returning to work (51%) or climbing stairs (16%). They reported anxiety when using computers (39%), mobile phones (51%), microwaves (73%) and even electric toothbrushes (51%). It has been observed that patients with a greater general understanding of the pacemaker and post-implantation restraints had a higher quality of life on average. Conclusions: Patients with CIEDs restrain themselves excessively in daily living. There is a strong need to provide them with knowledge of their medical condition, concomitant capabilities, and limitations to undergo a fully successful rehabilitation. Comprehensive and easily comprehensible recommendations may play a key role in improving patients' quality of life. [ABSTRACT FROM AUTHOR]

Background: At peak COVID-19 lockdown, patients with symptomatic atrial fibrillation (AF) were faced with an equipoise between a palliative rate-control versus cautious rhythm-control strategy, including hospitalization for initiation of antiarrhythmic drug/s (AADs) and cardiac procedures which was impossible due to hospitalization restrictions. Objectives: We aimed to evaluate the efficacy and safety of outpatient initiation of dofetilide in patients with AF using cardiac implantable electronic devices (CIEDs) for rhythm and QTc interval monitoring. Methods: Adult patients with symptomatic AF with prior failure or intolerance to other AADs were enrolled if they were willing to in-office insertion of implantable loop recorders or already implanted with pacemakers or defibrillators capable of remote monitoring. Exclusion criteria were known medical contraindications of dofetilide and unable to provide consent. After making a shared management decision, dofetilide was initiated in a physician office, and rhythm and QTc intervals were monitored by ECGs and CIEDs. Patients were followed to assess the efficacy and safety of the treatment. Results: The study cohort comprised of 30 patients, age 76 ± 7 years (mean ± standard deviation), 10 female (33%), CHA2DS2-VASc score 3.25 ± 1.3, ejection fraction 63.45% ± 8.52, and QTc interval 431.68 ± 45.09 ms. From 22 (73%) patients in AF at presentation, SR was restored in 14 (64%) patients after 4 doses of dofetilide. At 46 ± 59 days of follow-up, maintenance of SR in total 22 (73%) patients without cardiac adverse effects was accomplished. Conclusion: Effective and safe outpatient initiation of dofetilide during the extenuating circumstance of COVID-19 lockdown was possible in patients with AF who had CIEDs. [ABSTRACT FROM AUTHOR]

Anesthesiologists increasingly are involved in the perioperative management of cardiac implantable electronic devices (CIEDs). The variety of devices available and the ongoing advancements in technology, programming capabilities, and responses to conventional management (eg, magnet application) complicate the management of these devices. As an aid to this clinical challenge, this manuscript reviews 469 interrogations performed by a single cardiac anesthesiologist during a 4.5-year period to derive useful information with which to guide anesthesiologists who have chosen to pursue training in this area of perioperative care. Retrospective review of prospectively collected data. Single institution, quaternary care hospital. Patients with CIEDs presenting for surgery; the quality assurance (QA) reports of 469 interrogations performed between May 2015 and September 2019 were reviewed. No intervention. The distributions of surgical procedures, device types, device manufacturers, pacing modes, rate-response sensors, special functions, and performed interventions were reviewed and analyzed. The QA reports were evaluated to identify information or experiences that demonstrated important lessons for anesthesiologists engaging in perioperative CIED management. This database review provides general guidance for anesthesiologists managing CIEDs in the perioperative period. Concepts germane to the operating room are emphasized. [ABSTRACT FROM AUTHOR]

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Abstract Background There have been a few cases of echogenic cardiac implantable electric device (CIED) lead‐associated oscillating intracardiac masses (ICMs) in leads imaged by echocardiography. The histological properties of ICMs could help clarify the etiological diagnosis. Although there is extensive literature on mass size, the histological properties of such masses have not been characterized. The aim of this research was to clarify the histological features of oscillating ICMs in CIED patients. Methods Preoperative echocardiography was performed in all candidates for CIED removal. In the patients with ICMs, specimens were obtained by 3 methods: direct tissue collection during open‐heart surgery; tissue collection together with the CIED lead during transvenous extraction; and tissue collection by catheter vacuum during transvenous CIED removal. A standard histopathological examination of ICM tissue was performed. Results A total of 106 patients underwent lead removal in our institute (April 2009‐March 2018); 14 patients had an ICM (13.2%), and 7 specimens were obtained in patients with CIED lead‐related ICM. Following histological examination, 2 types of ICM were identified: one mainly composed of thickened endocardium (EN type; 3 patients), and the other mainly an aggregate of inflammatory cells as a neutrophil cell (NC type; 4 patients). Conclusions Two histological types of intracardiac masses, including a thickened endocardium type and a neutrophil cell type, were identified. These classifications might help make an accurate histological diagnosis of lead‐associated intracardiac masses.

Background: Limited data are available on leadless pacemaker (LPM) outcomes according to different stages of chronic kidney disease (CKD)., Objective: The purpose of this study was to investigate differences in the safety and efficacy of LPMs among patients stratified per different stages of renal function., Methods: Consecutive patients enrolled in the multicenter international i-LEAPER registry (International LEAdless PacemakEr Registry) were analyzed. Patients were divided into 3 groups according to CKD stage. The primary end point was the comparison of LPM-related major complication rate at implantation and during follow-up. Differences in electrical performance were deemed secondary outcomes., Results: Of the 1748 patients enrolled, 33% were in CKD stage G3a/G3b and 9.4% were in CKD stage G4/G5. Patients with CKD presented cardiovascular comorbidities more frequently. During a median follow-up of 39 months (interquartile range [IQR] 18-59 months), major complication rate did not differ between groups (normal kidney function [NKF] group 1.8% vs CKD stage G3a/G3b group 2.9% vs CKD stage G4/G5 group 2.4%; P = .418). All-cause mortality resulted higher in the CKD stage G4/G5 group than in the NKF group (19.5% vs 9.8%; adjusted hazard ratio 1.9; 95% confidence interval 1.25-2.89; P = .003). LPM electrical performance was comparable between groups, except for patients with CKD who showed a slightly higher pacing threshold during 1-month follow-up (NKF group 0.50 V [IQR 0.35-0.70 V] vs G3a/G3b group 0.56 V [IQR 0.38-0.81 V] vs G4/G5 group 0.51 V [0.38-0.84 V] @ 0.24 ms; P < .001)., Conclusion: In a real-world setting, patients with advanced CKD who underwent LPM implantation were underrepresented. Although all-cause mortality was higher in end-stage CKD, periprocedural complications and LPM performance were overall comparable between NKF and different stages of CKD, except for higher values of pacing threshold in patients with CKD up to first-month follow-up., Competing Interests: Disclosures Dr Tondo is a member of an advisory board of Medtronic. Other authors do not report disclosures regarding this article., (Copyright © 2024 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.)

Cardiac implantable electronic devices (CIEDs) offer the benefit of remote monitoring and decision making and find particular applications in special populations such as the elderly. Less transportation, reduced costs, prompt diagnosis, a sense of security, and continuous real-time monitoring are the main advantages. On the other hand, less physician-patient interactions and the technology barrier in the elderly pose specific problems in remote monitoring. CIEDs nowadays are abundant and are mostly represented by rhythm control/monitoring devices, whereas hemodynamic remote monitoring devices are gaining popularity and are evolving and becoming refined. Future directions include the involvement of artificial intelligence, yet disparities of availability, lack of follow-up data, and insufficient patient education are still areas to be improved. This review aims to describe the role of CIED in the very elderly and highlight the merits and possible drawbacks.

Aims: Debulking of infective mass to reduce the burden if infective material is a fundamental principle in the surgical management of infection. The aim of this study was to investigate the validity of this principle in patients undergoing transvenous lead extraction in the context of bloodstream infection (BSI)., Methods and Results: We performed an observational single-centre study on patients that underwent transvenous lead extraction due to a BSI, with or without lead-associated vegetations, in combination with a percutaneous aspiration system during the study period 2015-22. One hundred thirty-seven patients were included in the final analysis. In patients with an active BSI at the time of intervention, the use of a percutaneous aspiration system had a significant impact on survival (log-rank: P = 0.0082), while for patients with a suppressed BSI at the time of intervention, the use of a percutaneous aspiration system had no significant impact on survival (log-rank: P = 0.25)., Conclusion: A reduction of the infective burden by percutaneous debulking of lead vegetations might improve survival in patients with an active BSI., Competing Interests: Conflict of interest: C.S. has received workshop fees, consulting fees, educational grants, and research support from Cook Medical and consulting fees from AngioDynamics. R.H. has received research support from AngioDynamics., (© The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.)

One of the most concerning adverse events related to the SARS-CoV-2 vaccination is arrhythmia. To ascertain the relationship between vaccination and arrhythmic events, we studied the occurrence of arrhythmia in patients with cardiac implantable electronic devices (CIEDs) before and after a SARS-CoV-2 vaccination. Patients with CIEDs aged ≥18 who visited the CIED clinic at King Chulalongkorn Memorial Hospital and Vajira hospital from August 2021 to February 2022 were included. Information about the SARS-CoV-2 vaccination and side effects was obtained. One hundred eighty patients were included in our study, which compared the incidence of arrhythmias in the 14 days post-vaccination to the 14 days before vaccination. The median age was 70 years. The number of patients who received one, two, and three doses of the vaccine was 180, 88, and 4, respectively. ChAdOx1 was the primary vaccine used in our institutes, accounting for 86% of vaccinations. The vaccination was significantly associated with a 73% increase incidence of supraventricular tachycardia (SVT). In an adjusted model, factors associated with the incidence of SVT were the post-vaccination period, female sex, increasing BMI, chronic kidney disease, and a history of atrial fibrillation. Increased ventricular arrhythmia (VA) episodes were also associated with the post-vaccination period, female sex, decreasing BMI, and chronic kidney disease, but to a lesser degree than those with SVT episodes. No life-threatening arrhythmia was noted in this study. In conclusion, the incidence of arrhythmia in patients implanted with CIEDs was significantly increased after the SARS-CoV-2 vaccination.

Background: Transvenous lead extraction (TLE) is standard of care for the management of patients with cardiac implantable electronic device infection or lead‐related complications. Currently, objective data on TLE in Latin America is lacking. Objective: To describe the current practice standards in Latin American centers performing TLE. Methods: An online survey was sent through the mailing list of the Latin American Heart Rhythm Society. Online reminders were sent through the mailing list; duplicate answers were discarded. The survey was available for 1 month, after which no more answers were accepted. Results: A total of 48 answers were received, from 44 different institutions (39.6% from Colombia, 27.1% from Brazil), with most respondents (82%) being electrophysiologists. Twenty‐nine institutions (66%) performed <10 lead extractions/year, with 7 (16%) institutions not performing lead extraction. Although most institutions in which lead extraction is performed reported using several tools, mechanical rotating sheaths were cited as the main tool (66%) and only 13% reported the use of laser sheaths. Management of infected leads was performed according to current guidelines. Conclusion: This survey is the first attempt to provide information on TLE procedures in Latin America and could provide useful information for future prospective registries. According to our results, the number of centers performing high volume lead extraction in Latin America is smaller than that reported in other continents, with most interventions performed using mechanical tools. Future prospective registries assessing acute and long‐term success are needed. [ABSTRACT FROM AUTHOR]

Background: Implantable pacemakers and implantable cardioverter-defibrillators (ICDs) are designed to include a "magnet mode" feature that can be activated from magnets stronger than 10 G. This feature is designed to be used when a patient is undergoing a procedure where electromagnetic interference is possible, or anytime suspension of tachycardia detection and therapy is needed. A publication in Heart Rhythm demonstrates an iPhone 12 triggering the magnet mode of a Medtronic ICD.Objective: The purpose of this study is to determine the separation distance between consumer electronic devices that may create magnetic interference, including cell phones and smart watches, and implantable pacemakers and ICDs where magnet mode can be triggered.Methods: The static magnetic fields of the iPhone 12 models and Apple Watch were measured at several planes in 1 cm resolution using an FW Bell 5180 Gauss Meter with STD18-0404 Transverse probe (unidirectional probe).Results: All iPhone 12 and Apple Watch 6 models tested have static magnetic fields significantly greater than 10 G in close proximity (1-11 mm), which attenuates to below 10 G between 11 and 20 mm.Conclusion: The findings of this study support the US Food and Drug Administration recommendation that patients keep any consumer electronic devices that may create magnetic interference, including cell phones and smart watches, at least 6 inches away from implanted medical devices, in particular pacemakers and cardiac defibrillators. [ABSTRACT FROM AUTHOR]

Purpose: Cardiac implantable electronic devices (CIED) are sensitive to scattered secondary neutrons from proton beam irradiation. This experimental in vitro study investigated risk of CIED errors during pencil beam proton therapy.Methods and Materials: We used 62 explanted CIEDs from 4 manufacturers; 49 CIEDs were subjected to a simulated clinical protocol with daily 2 Gy relative biological effectiveness fractions prescribed to the phantom. Devices were located at 3 different lateral distances from the spread-out Bragg peak to investigate the risk of permanent or temporary device errors. Additionally, 13 devices with leads connected were monitored live during consecutive irradiations to investigate the risk of noise, over- or undersense, pace inhibition, and inappropriate shock therapy.Results: We detected 61 reset errors in 1728 fractions, and all except 1 CIED were reprogrammed to normal function. All, except 1 reset, occurred in devices from the same manufacturer. These were successfully reprogrammed to normal function. The 1 remaining CIED was locked in permanent safety mode. Secondary neutron dose, as estimated by Monte Carlo simulations, was found to significantly increase the odds of CIED resets by 55% per mSv. Clinically significant battery depletion was observed in 5 devices. We observed no noise, over- or undersense, pace inhibition, or inappropriate shock therapy during 362 fractions of live monitoring.Conclusions: Reprogrammable CIED reset was the most commonly observed malfunction during proton therapy, and reset risk depended on secondary neutron exposure. The benefits of proton therapy are expected to outweigh the risk of CIED malfunctioning for most patients. [ABSTRACT FROM AUTHOR]

Background: Cardiac implantable electronic device (CIED) therapy contributes to an improvement in morbidity and mortality across all patient demographics. Patient age is a recognized risk factor for unfavorable outcomes in invasive procedures. This is the largest series of non‐laser transvenous lead extraction (TLE) evaluating the association between patient age and procedure outcomes. Methods: Data of 2205 (3849 leads) patients was collected retrospectively from six European TLE centers between January 2005–December 2018 in the PROMET study. Of these, 153 patients with 319 leads were excluded for incomplete data. A comparison of outcomes was performed between the age groups young [< 50 years], young intermediate [50–69 years], older intermediate [70–79 years], and octogenarian [≥80 years]. Results: Infection was most common indication for TLE in the octogenarian cohort, less common in the younger population (60.1% vs. 33.2%, respectively, p <.01). High‐voltage leads were extracted most frequently from young patients, less frequently from octogenarians (31.6% vs. 10%, p <.001), while the opposite was evident for pacemaker leads (p <.001). Rotational sheath use was equally prevalent across all patient groups (p =.79). Minor and major complications across all the age groups were statistically similar, as was procedural success; the 30‐day mortality was most significant in the octogenarian and least in the young patients (4.9% vs. 0.4%, p =.005). Propensity matching multivariate analysis found systemic infection, lead dwell time, and patient age (p =.013, OR 1.064 [1.013–1.116]) increased risk of 30‐day mortality. Conclusion: TLE is safe and effective across all age groups. 30‐day mortality risk is significantly higher in the older patients. [ABSTRACT FROM AUTHOR]