Cardiac Implantable Devices Research Articles

Thrombosis of the superior vena cava in a patient with an implanted cardioverter–defibrillator: A case report

BACKGROUND: Superior vena cava syndrome results from the occlusion of blood flow in the superior vena cava due to external compression, internal obstruction, or infiltration of the vessel wall by a tumor. Although thrombotic complications caused by electrodes of cardiac implantable devices are uncommon in clinical practice, their incidence has been increasing due to the increasing need for such devices, which effectively correct the compromised electrical or mechanical functions of the heart chambers. CLINICAL CASE DESCRIPTION: Herein, we have presented a case of superior vena cava thrombosis syndrome in a patient who had undergone cardioverter–defibrillator implantation for dilated cardiomyopathy. We have discussed the classification of superior vena cava syndromes, its pathogenesis, and the types of collateral circulation. CONCLUSION: As observed in our patient, the concurrent presence of chronic heart failure syndrome can make it challenging to recognize superior vena cava syndrome in the early stages of diagnosis.

Sustainability inspired fabrication of next generation neurostimulation and cardiac rhythm management electrodes via reactive hierarchical surface restructuring

Over the last two decades, platinum group metals (PGMs) and their alloys have dominated as the materials of choice for electrodes in long-term implantable neurostimulation and cardiac rhythm management devices due to their superior conductivity, mechanical and chemical stability, biocompatibility, corrosion resistance, radiopacity, and electrochemical performance. Despite these benefits, PGM manufacturing processes are extremely costly, complex, and challenging with potential health hazards. Additionally, the volatility in PGM prices and their high supply risk, combined with their scarce concentration of approximately 0.01 ppm in the earth’s upper crust and limited mining geographical areas, underscores their classification as critical raw materials, thus, their effective recovery or substitution worldwide is of paramount importance. Since postmortem recovery from deceased patients and/or refining of PGMs that are used in the manufacturing of the electrodes and microelectrode arrays is extremely rare, challenging, and highly costly, therefore, substitution of PGM-based electrodes with other biocompatible materials that can yield electrochemical performance values equal or greater than PGMs is the only viable and sustainable solution to reduce and ultimately substitute the use of PGMs in long-term implantable neurostimulation and cardiac rhythm management devices. In this article, we demonstrate for the first time how the novel technique of “reactive hierarchical surface restructuring” can be utilized on titanium—that is widely used in many non-stimulation medical device and implant applications—to manufacture biocompatible, low-cost, sustainable, and high-performing neurostimulation and cardiac rhythm management electrodes. We have shown how the surface of titanium electrodes with extremely poor electrochemical performance undergoes compositional and topographical transformations that result in electrodes with outstanding electrochemical performance.

Incidence of Staphylococcus aureus Bacteremia in Patients Following Implantation of Cardiac Implantable Electronic Devices: A Danish Nationwide Cohort Study.

Staphylococcus aureus bacteremia (SAB) is a high-risk condition associated with high morbidity and mortality. In the presence of cardiac implantable electronic devices (CIEDs), SAB may cause or clinically indicate device infection. We aimed to estimate the 10-year absolute risk of SAB in adult Danish first-time CIED carriers. Secondary aims included identification of risk factors associated with SAB. A registry-based study utilizing Danish nationwide registers and including consecutive Danish patients undergoing first CIED implantation between 2000 and 2020 was conducted. The primary outcome was first-time SAB after CIED implantation. A total of 87 257 patients with first CIED implantation in the study period were identified (median age, 75 years; 62.6% were male; median follow-up, 3.8 years). Patients with pacemakers (PMs) were older and with more noncardiovascular comorbidities compared to patients with implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy devices with or without defibrillator capacity (CRTs). In total, 1366 patients (1.6%) developed SAB. The 10-year absolute risk (95% confidence interval) of SAB was 2.0% (1.9%-2.1%) for PM, 2.6% (2.2%-3.1%) for ICD, and 3.7% (3.0%-4.5%) for CRT. A multivariable Cox analysis identified hemodialysis (hazard ratio [HR], 8.51), SAB before CIED (HR, 2.76), liver disease (HR, 2.35), and carrying a CRT device (HR, 1.68) among the covariates associated with increased risk of SAB. The absolute risk of SAB in Danish CIED carriers increased with more advanced CIED systems. The risk was highest within the first 3 months after CIED implantation and increased with the presence of certain covariates including renal dialysis, SAB before CIED, male sex, and advancing age.

Incidence, Time Course, and Outcomes of Worsening Tricuspid Regurgitation Following Transvenous Cardiac Implantable Electronic Device Implantation

Data regarding the incidence, time course, and outcomes of worsening tricuspid regurgitation (TR) after transvenous cardiac implantable electronic device (CIED) implantation are limited. We screened 834 consecutive patients who underwent first-time transvenous CIED implantation. After excluding patients without preoperative or follow-up echocardiography (n = 361) and patients with severe TR before implantation (n = 15), the present study population consisted of 458 patients. Worsening TR was defined as moderate or more TR that was newly developed or increased by at least 1 grade compared with baseline. During the median follow-up period of 2.1 years, worsening TR occurred in 93 patients (20%). The cumulative incidence of worsening TR was 10.2% at 1 year and 18.6% at 3 years. Of the 67 patients with worsening TR who underwent follow-up echocardiography, excluding those who underwent tricuspid valve surgery, 76% showed improvement in TR severity, with 70% having none or mild TR. On the landmark analysis, the 5-year cumulative incidence of all-cause death and heart failure hospitalization was significantly higher in patients with worsening TR at 1 year than those without worsening TR at 1 year (24.8% vs 11.4%, p = 0.002 and 35.2% vs 17.9%, p = 0.012, respectively). When considering worsening TR as a time-dependent covariate, worsening TR was significantly associated with an increased risk of all-cause death and heart failure hospitalization after adjustment for the differences in baseline patient characteristics (hazard ratio 1.99, 95% confidence interval 1.21 to 3.27, p = 0.006 and hazard ratio 2.64, 95% confidence interval 1.59 to 4.37, p <0.001, respectively). In conclusion, worsening TR after transvenous CIED implantation was not uncommon and had a dynamic nature with an improvement in the majority of patients, suggesting the functional etiology. Nonetheless, worsening TR was independently associated with an increased risk for mortality and heart failure hospitalization.

Economic Evaluation of Remote Monitoring for Implantable Cardiac Devices: Evidence from a Remote-Care Study.

The adoption of remote monitoring (RM) is especially relevant for patients with implantable cardiac devices due to their high risk of hospitalization and the need for frequent outpatient visits. Though RM can help with early detection of cardiac episodes, it may also increase the number of tasks healthcare providers engage in to monitor patients' health. The adoption of RM may increase healthcare providers' workloads, potentially impacting the quality of care and increasing the risk of clinician-provider burnout. Little is known about the link between RM adoption and changes in healthcare providers' workloads. Using data from a non-randomized clinical trial conducted in 2021-2022 at a University Hospital in Korea, we examined the relationship between RM adoption and changes in patient time savings and healthcare providers' workloads. The clinical trial included patients with a cardiac implantable electronic device compatible with the Biotronik Home Monitoring System. For patients, RM was associated with a 41-minute decrease in total visit duration, attributed to reductions in both wait time (37 minutes; P<0.001) and total examination time (3.7 minutes; P=0.137). For healthcare providers, RM was linked to an increase in overall workload by 107.9 minutes per patient. The increase was primarily due to managing RM alerts (91.8 minutes) and preparing monthly patient reports (19.9 minutes). Our findings suggest that RM was associated with a decrease of 1540 KRW (44%) in average cost of care per minute. RM is associated with time-saving patient benefits and increased healthcare providers' workloads. Even though this was a single-center study with a small number of patients, our research highlights the importance of carefully examining changes in healthcare staff workloads linked to the adoption of RM within the national health insurance system.

Surgical skill simulation training to proficiency reduces procedural errors among novice cardiac device implanters: a randomized study.

In cardiac device implantation, having both surgical skills and ability to manipulate catheter/lead/wire is crucial. Few cardiologists, however, receive formal surgical training prior to implanting. Skills are mostly acquired directly on-the-job and surgical technique varies across institutions; suboptimal approaches may increase complications. We investigated how novel proficiency-based progression (PBP) simulation training impacts the surgical quality of implantations, compared to traditional simulation (SIM) training. In this international prospective study, novice implanters were randomized (blinded) 1:1 to participate in a simulation-based procedure training curriculum, with proficiency demonstration requirements for advancing (PBP approach) or without (SIM). Ultimately, trainees performed the surgical tasks of an implant on a porcine tissue that was video-recorded and then scored by two independent assessors (blinded to group), using previously validated performance metrics. Primary outcomes were the number of procedural Steps Completed, Critical Errors, Errors (non-critical), and All Errors Combined. Thirty novice implanters from 10 countries participated. Baseline experiences were similar between groups. Compared to SIM-trained, the PBP-trained group completed on average 11% more procedural Steps (P < 0.001) and made 61.2% fewer Critical Errors (P < 0.001), 57.1% fewer Errors (P = 0.140), and 60.7% fewer All Errors Combined (P = 0.001); 11/15 (73%) PBP trainees demonstrated the predefined target performance level vs. 3/15 SIM trainees (20%) in the video-recorded performance. Proficiency-based progression training produces superior objectively assessed novice operators' surgical performance in device implantation compared with traditional (simulation) training. Systematic PBP incorporation into formal academic surgical skills training is recommended before in vivo device practice. Future studies will quantify PBP training's effect on surgery-related device complications.

Predictors of Mortality in Patients with Cardiac Device-Related Infective Endocarditis.

Infective endocarditis (IE) associated with implantable cardiac devices (ICD) is a serious disease with high mortality rates. The increased number of ICD implants has led to increased ICD infection rates. The aim of this study was to characterize clinical, laboratory profiles and the prognosis of cardiac-device-related endocarditis (CDIE), as well as to identify predictors of in-hospital death. A total of 274 patients with IE were included in a prospective cohort (2007-2019). From these, 82 patients (30%) had CDIE (46 pacemakers, 23 cardioverter defibrillators, and 13 cardiac resynchronization therapy devices). Predisposed conditions; clinical, laboratory and echocardiographic parameters; etiologic agents; and in-hospital outcomes were evaluated. The mean age was 55.8 ± 16.4 years, where 64.6% were male. Among the clinical manifestations at diagnosis, the most prevalent were heart failure (67.9%), fever (60.5%), anorexia/hyporexia (44.4%), and heart murmur (37.5%). The median serum C-reactive protein (CRP) level at diagnosis was 63 mg/L (interquartile range [IQR] 20-161). Etiological agents were identified through positive blood cultures in 55% of cases. The main etiologic agents were negative-coagulase staphylococci (19.5%) and Staphylococcus aureus (18.3%). Vegetation was identified in 74 patients (90.1%). In-hospital mortality was 28%. CRP concentrations at diagnosis were identified as markers of disease severity (odds ratio [OR] 1.006; 95%CI 1.001-1.011; p = 0.016), and the worsening of heart failure was associated with unfavorable outcomes (OR 3.105; 95%CI 1.397-6.902; p = 0.005). Unlike what is traditionally accepted, CDIE does not have a better prognosis.

Subcutaneous versus Transvenous Implantable Cardioverter Defibrillator in Patients with End-Stage Renal Disease Requiring Dialysis: Extended Long-Term Retrospective Multicenter Follow-Up.

Implantable cardioverter defibrillators (ICD) prevent sudden cardiac death (SCD). Patients with end-stage renal disease (ESRD) requiring dialysis are at a very high risk of infection from cardiac implantable electronic device (CIED) implantation as well as mortality. In the present study, we compared the long-term complications and outcomes between subcutaneous ICD (S-ICD) and transvenous ICD (TV-ICD) recipients. In this retrospective analysis, we analyzed a total of 43 patients with ESRD requiring dialysis who received either a prophylactic S-ICD (26 patients) or a single right ventricular lead TV-ICD (17 patients) at seven experienced centers in Germany. Follow-up was performed bi-annually, at the end of which the data concerning comorbidities and, if applicable, reason for death were checked and confirmed with patients' general practitioner, nephrologist and cardiologist. The median follow up duration was 95.6 months (range 42.8-126.3 months). Baseline characteristics were without noteworthy significant differences between groups. During follow-up (FU), there were significantly more device-associated infections (HR 8.72, 95% confidence interval (CI), 1.18 to 12.85, p < 0.05) and device-associated hospitalizations (HR 10.20, 95% CI 1.22 to 84.61, p < 0.001), as well as a higher cardiovascular mortality (HR 9.17, 95% CI 1.12 to 8.33, p < 0.05), in the TV-ICD group. The number of patients requiring hospitalization for any reason was significantly higher in the TV-ICD group (HR 2.59, 95% CI 1.12 to 6.41, p < 0.05). There was no significant difference in overall mortality (HR 1.92, 95% CI 0.96 to 6.15, p = 0.274). Our data suggest that, in this extended follow-up in seriously compromised renal patients on dialysis, the S-ICD patients have statistically fewer device infections and hospitalizations as well as lower cardiac mortality compared with the TV-ICD cohort.

Microporous polysaccharide hemospheres for reducing pocket hematomas after cardiac device implantation in patients on antithrombotic therapy.

Various surgical procedures have employed microporous polysaccharide hemosphere (MPH) hemostatic agents. However, data regarding their effectiveness in preventing pocket hematomas (PHs) during the implantation of cardiac implantable electronic devices (CIED) among the Asian population are limited. Therefore, this study aimed to investigate the potential benefits of using MPH hemostatic agents during CIED implantations as a preventive measure against post-procedural PHs. We conducted a retrospective, single-center, observational study involving 255 consecutive Japanese patients who underwent CIED implantation between November 2017 and April 2021. We compared PH occurrences within 28 days after CIED implantation between patients who received MPH hemostatic agents (n = 145) and those who did not (n = 110). PH development was observed in nine (6.2%) patients who received MPH hemostatic agents and in 13 (11.8%) patients without MPH hemostatic (p = .111). Kaplan-Meier analysis of PH development revealed no significant difference between the two groups (log-rank p = .102). However, utilizing MPH hemostatic agents among patients taking antithrombotic drugs, including antiplatelet medications, direct oral anticoagulants, and warfarin, significantly reduced PH incidence (log-rank p = .03). The multivariate Cox proportional hazards model demonstrated that MPH hemostatic agent utilization independently correlated with a decreased PH risk (hazard ratio 0.22, 95% confidence interval 0.08-0.63, p = .004). The findings of this study suggest that the incorporation of MPH hemostatic agents into standard practice may benefit to mitigate PH risk during CIED implantations in patients on antithrombotic therapy. This simple and practical measure may be valuable, especially in high-risk patients, such as those taking antithrombotic medications.

Switching to a 100% remote follow-up of implantable cardiac electronic devices: Organizational model and results of a single center experience.

During the SARS-CoV-2 COVID-19 pandemic, the global health system needed to review important processes involved in daily routines such as outpatient activities within the hospital, including follow-up visits of implantable cardiac electronic devices (CIEDs) carried out in office. The aim of this study is to describe our 3.5 years of real-world experience of a full remote CIED follow-up, evaluate the success rate of remote transmissions, and verify the adopted organizational model. From April 2020 to November 2023, all patients with an activated and well-functioning remote monitoring (RM) system and automatic algorithms, like autocapture and autosensing, underwent exclusive RM follow-up. Unscheduled in-office visits were only prompted by remote yellow or red alerts. Patients were divided into two groups, based on available technology: Manual Transmission System (MTS) and Automatic Transmission System (ATS). The ATS group, in addition to ensuring a daily transmission of any yellow or red alerts, was checked at least every 15 days to ensure a valid connection. An automatic transmission was scheduled once a year, irrespective of alerts occurred. The MTS group provided a manual transmission every 6 months. One thousand nine hundred thirty-seven consecutive patients were included in the study. By the end of November 2023, a total of 1409 patients (1192 in the ATS and 217 in the MTS group) were still actively followed by our remote clinic (384 expired, 137 dismissed, 7 transferred). The overall success rate of transmissions with the adopted organizational model was 96.6% in the ATS group (connection index) and 87% in the MTS group. Conventional in-hospital follow-up visits decreased by 44%. Total clinic working time, resulting from the sum of the time spent during in-hospital and remote follow-up, after an initial increase, was progressively reduced to the actual -25%. Mortality rate for any cause was 7.5% per year in remote follow-up patients and 8.3% (p=NS) in in-office patients. In the ATS group, no device malfunctions were notified to our remote clinic, before we had already realized it through appropriate alerts. The available technology makes moving to a 100% remote clinic possible, without overwhelming clinic workflow, safely. Adopting an appropriate organizational model, it is possible to maintain high transmission success rates. The automatic transmissions allow a more frequent control of patients with CIED.

Safety and feasibility of cardiac electrophysiology procedures in ambulatory surgery centers

BackgroundDespite their improved safety, by and large, cardiac electrophysiology procedures including catheter ablation (CA), are presently performed in hospital outpatient departments. ObjectiveThis large multicenter study investigated the safety and outcomes associated with various cardiac electrophysiology procedures performed at 6 ambulatory surgery centers (ASCs), primarily during the coronavirus disease 2019 pandemic under the Center for Medicare and Medicaid Services Hospitals Without Walls program. MethodsWe retrospectively analyzed the outcomes from consecutive electrophysiology procedures performed in ASCs with same-day discharge, including transesophageal echocardiography, cardioversion, cardiac implantable electronic device (CIED) implantation, electrophysiology studies, and CA for atrial fibrillation (AF), atrial flutter (AFL)/supraventricular tachycardia, ventricular premature complexes (VPCs), and atrioventricular node. ResultsAltogether, 4037 procedures were performed, including 779 transesophageal echocardiography/cardioversion procedures (19.3%), 1453 CIED implantation procedures (36.0%), 26 electrophysiology studies (0.6%), and 1779 CA procedures (44.1%) for AF (75.4%), AFL/supraventricular tachycardia (18.8%), VPC (4.7%), and atrioventricular node (1.1%). Overall, 80.2% of CA procedures were for left-sided atrial arrhythmias (AF/atypical AFL) requiring transseptal catheterization. Left-sided VPC ablation procedures (42.2%) were performed using a transseptal/retrograde approach. Adverse event rates were low, but comparable between CIED implantation and CA (0.76% vs 0.73%; P = .93), as were the incidences of urgent/unplanned postprocedure hospitalization (0.48% vs 0.45%; P = .89), respectively. Moreover, the adverse event rates in ASCs vs hospital outpatient departments did not differ for CIED (0.76% vs 0.65%; P = .71) or CA (0.73% vs 0.80%; P = .79). ConclusionThe results from this large multicenter study suggest that ASCs represent a safe and effective setting to perform a variety of cardiac electrophysiology procedures including CA. These findings bear important implications for healthcare delivery and policy.

Left bundle branch block cardiomyopathy (LBBB-CMP): from the not-so-benign finding of idiopathic LBBB to LBBB-CMP diagnosis and treatment.

two main objectives: (1) to explore the natural history of "asymptomatic" iLBBB carriers; (2) to characterize the outcomes and therapeutic approach used in a "real-world" cohort of possible LBBB-CMP patients (pts). tertiary care centre retrospective study of pts with iLBBB and possible LBBB-CMP, screened from a large hospital electrocardiographic database from 2011 to 2017 (LBBB = 347). To assign the 1st objective, only pts with left ventricular ejection fraction (LVEF) ≥ 50% and available follow-up (FU) data were included (n = 152). Regarding the 2nd objective, possible LBBB-CMP pts were selected and defined as iLBBB pts with LVD (LVEF < 50%) and no secondary causes for LVD (n = 53). Data were based on pts' careful review of medical records. focusing our 1st objective, 152 iLBBB carriers were identified. Median FU time were 8years, and 61% were female. During FU, approximately 25% developed LVD, 20% needed ≥ 1 cardiovascular (CV) hospitalization, and 15% needed a cardiac device implantation. The majority (2/3) of pts with LVD on FU (n = 35) had no secondary causes for LVD, being classified as possible LBBB-CMP pts. Time-to-LVD analysis showed no differences between pts with a known cause for LVD vs LBBB-CMP pts (Log-rank = 0.713). Concerning the 2nd objective, 53 possible LBBB-CMP pts were identified. Median FU time were 10years, and 51% were female. During the FU, 77% presented heart failure (HF) symptoms, and 42% needed ≥ 1 CV hospitalization, mainly due to HF. Half presented severe LVD at some point in time, and 55% needed a cardiac device, most of them a cardiac resynchronization therapy (CRT) device. Comparing CRT with non-CRT pts, no differences were found in terms of medical therapy, but better outcomes were observed in CRT group: LVEF improvement was higher (median LVEF improvement of 11% in non-CRT vs 27% in CRT; p < 0.001), and fully recovery from LVD was more frequent (50% of CRT vs 14% non-CRT; p = 0.028). our data strengthen current evidence on natural history of iLBBB, showing significant CV morbidity associated with the presence of iLBBB, and reinforces the need for a serial and proper FU of these carriers. Our data on "real-world" possible LBBB-CMP pts shows high rates of CV events, namely HF-related events, and supports the growing evidence pointing out CRT as this subgroup of pts' cornerstone of treatment. In conclusion, our work sheds additional light on these largely unknown topics and underlines the urgent need for larger and prospective studies addressing the identification of LVD development predictors in iLBBB carriers, as well as the establishment of diagnostic criteria and therapeutic approach for LBBB-CMP.

The primary nursing model of remote monitoring in patients with implantable cardiac devices (CIED)

Abstract Introduction The treatment of cardiac pathologies with devices has led to an exponential increase in patients with CIED, who need more frequent, more careful check-ups, with a consequent increase in the number and clinical complexity of patients who refer to cardiac stimulation centers. Aim The use of remote monitoring makes it possible to have a continuous flow of information relating not only to the performance of the device but also to clinical events such as arrhythmias and heart failure without the need for direct contact, drastically reducing hospital accesses and at the same time promptly detecting any critical issues that require intervention in a more or less short time. The benefits of remote monitoring, as we have seen over the years, intervene at multiple levels, economic, social and clinical. Materials and methods Numerous studies have shown how remote monitoring can replace outpatient check-ups without compromising patient safety, reducing resource consumption, while scheduling at least one outpatient follow-up per year as recommended by international guidelines. With the introduction of telecardiology and remote monitoring in clinical practice, new organizational models have been implemented, which harmonize and codify the activity of the various professionals involved in the diagnostic and therapeutic process. This model must guarantee a precise definition of roles and responsibilities, traceability of actions, continuity of care, low consumption of resources, patient satisfaction and acceptance, integration with traditional hospital and out-of-hospital diagnosis and treatment pathways. A model that encompasses all these peculiar features is the PRIMARY NURSE MODEL. Primary nursing is a relationship based and resource driven system of care delivery, the building blocks are: attribution and acceptance by each individual of personal responsibility in making decisions; assignment of day to day care according to the case method; direct person to person communication; a person operationally responsible for the quality of care provided to patients. The decentralised decision making approach is based on three basic concepts: the nurse's decision making authority, responsibility and accountability. Results and conclusions The real CORE of this model is represented by the responsibility for the decisions made by a single nurse. Then each patient is assigned to a nurse responsible for continuity of care, whose duties include patient and caregiver education and training, website data entry, review of critical case transmissions and assessments, and submission of critical cases to the physician.

Contemporary Role of Positron Emission Tomography (PET) in Endocarditis: A Narrative Review.

Endocarditis, a serious infectious disease, remains a diagnostic challenge in contemporary clinical practice. The advent of advanced imaging modalities has contributed significantly to the improved understanding and management of this complex disease. 18F-fluorodeoxyglucose (18F-FDG) positron emission tomography (PET) imaging has shown remarkable potential in improving the diagnostic accuracy of endocarditis. In the update of the Modified Duke Criteria, in 2023, The International Society for Cardiovascular Infectious Diseases (ISCVID) Working Group recognized specific 18F-FDG PET/CT findings as a major diagnostic criterion, particularly in patient with prosthetic valve endocarditis. The ability of PET to visualize metabolic activity allows for the identification of infective foci and could differentiate between infective and non-infective processes. This review examines the clinical utility of PET in differentiating infective endocarditis from other cardiovascular pathologies, highlighting its sensitivity and specificity in detecting native and prosthetic valve infections, including patients with transcatheter aortic valve implantation (TAVI), cardiac implantable devices (CIEDs), and left ventricular assistance devices (LVAD). Also, practical aspects and indications are illustrated to optimize the quality of imaging and reduce potential false positive results. In conclusion, the current use of PET in endocarditis has become a valuable diagnostic tool; as technological advances continue, PET will play an increasingly important role in the multidisciplinary approach to the management of endocarditis.

Long- and short-term outcomes after transvenous lead extraction in a large single-centre patient cohort using the clinical frailty scale as a risk assessment tool

Background and aimsThe rate of cardiac implantable electronic device (CIED) implantations and the need for transvenous lead extraction (TLE) are growing worldwide. This study examined a large Swedish cohort with the aim of identifying possible predictors of post-TLE mortality with special focus on systemic infection patients and frailty. MethodsThis was a single centre study. Records of patients undergoing TLE between 2010 and 2018 were analysed. Statistical analyses were conducted to compare baseline characteristics of patients with different indications and identify risk factors of 30-day and 1-year mortality. ResultsA total of 893 patients were identified. Local infection was the dominant indication and pacemaker was the most common CIED. The mean age was 65 ± 16 years, 73 % were male and median follow-up was 3.9 years. Heart failure was the most common comorbidity. Patients with systemic infection were significantly older, frailer and had significantly higher levels of comorbidities. 30-day mortality and 1-year mortality rates were 2.5 % and 9.9 %, respectively. Systemic infection and chronic kidney disease (CKD) were independently associated with 30-day and 1-year mortality. Clinical frailty scale (CFS) 5–7 correlated independently with 1-year mortality in the entire cohort and specifically in systemic infection patients. CKD, cardiac resynchronization therapy and CFS 5–7 were significant risk factors for long-term mortality (death >1 year after TLE) in multivariable analysis. ConclusionsSystemic infection, kidney failure in addition to the novel parameter of frailty were associated with post-TLE all-cause mortality. These risk factors should be considered during pre-procedure risk stratification to improve post-TLE outcomes.

Pocket Closure of CIED using Single Absorbable Subcuticular Suture Vicryl 3-0: A Single Operator Observational Study on Safety and Incidence of Pocket Site Infection

Pocket closure is a critical aspect of cardiac implantable electronic device (CIED) implantation procedures. Pocket infection is the most feared complication of CIED.The more complex CIED system implanted, the higher is the risk of infection. This observational study, conducted between July 2017 and June 2023, aimed to evaluate the safety and effectiveness of pocket closure using single absorbable 3 layers subcuticular suture Vicryl 3-0 in patients undergoing CIED implantation. A total of 564 consecutive patients were included in the study, with pocket closure performed using three layers of single continuous absorbable subcuticular suture Vicryl 3-0 and followed up on average of 3 years and 2 months. Postoperative outcomes, including the incidence of pocket site infections, device salvage success rate, and device explantation incidences were assessed. Results demonstrated a low incidence of pocket site infections (3.75%) and device explantation (0.34%), with satisfactory device salvage rates (81.9%) among infected cases with overall procedural success of 99.64 %. These findings support the safety and efficacy of pocket closure using absorbable subcuticular sutures in reducing postoperative complications and optimizing outcomes following CIED implantation.

Ultrasound Guided Pectoralis Nerve Block as a Novel Approach in Pacemaker Implantation

Abstract Background The use of implantable cardiac electronic devices (CEDs), including pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronized therapy (CRT), is increasing worldwide for the treatment of cardiac arrhythmias. The aim of this work was to evaluate the effectiveness of PECS I, PECS II blocks as the primary anesthesia technique in patients undergoing subcutaneous pacemaker in comparison to local infiltration anesthesia. Methods This prospective cohort randomized study was carried out on 40 patients between the ages of 21 to 80 years old undergoing pacemaker implantation in Aswan heart center. Patients were randomly allocated into two equal groups: Group (1): received Pecs block and group (2): control group, received standard local infiltration anesthesia with lidocaine 0.2 (10-15ml).All patients were subjected tolaboratory examinations) Hemoglobin, platelet count international normalized ratio, prothrombin time, partial thromboplastin time), Echocardiography (ECG), VAS, PCIA and preoperative medications. Results Number of patients required postoperative analgesia was significantly lower in group 1 compared to the group 2 (P value &amp;lt;0.001). Time to first require analgesia was significantly delayed in PECS blocks group compared to the control group and postoperative analgesia was significantly lower in group 1 compared to the group 2 (P value &amp;lt;0.001). The hospital stay was significantly lower in PECS blocks group compared to control group (&amp;lt;0.001). Conclusions Ultrasound guided PECs provided adequate analgesia as shown by reducing the times of start procedure and technique, postoperative pain scores and total opioid usage, delayed the time to first require analgesia and better operator and patient satisfaction in pacemaker implantation as compared to infiltration anesthesia.

British Heart Rhythm Society Standards for Implantation and Follow-up of Cardiac Rhythm Management Devices in Adults: January 2024 Update.

This updated guidance is designed to help with implantation and follow-up with agreed standards of practice. The update includes new guidance on subcutaneous defibrillators, leadless pacemakers and conduction system pacing. It includes new guidance on considerations at the time of a potential box change and techniques to be considered to minimise the risk of infection.

Analysis of survival time in patients receiving cardiac implantable devices after heart transplantation

Analysis of survival time in patients receiving cardiac implantable devices after heart transplantation

Unexpected Genetic Twists in Patients with Cardiac Devices.

Objective: To assess the frequency and types of genetic mutations in patients with arrhythmias who underwent cardiac device implantation. Methods: Retrospective observational study, including 38 patients with different arrhythmias and cardiac arrest as a first cardiac event. Treatment modalities encompass pacemakers, transvenous defibrillators, loop recorders, subcutaneous defibrillators, and cardiac resynchronization therapy. All patients underwent genetic testing, using commercially available panels (106-174 genes). Outcome measures include mortality, arrhythmia recurrence, and device-related complications. Results: Clinical parameters revealed a family history of sudden cardiac death in 19 patients (50%), who were predominantly male (58%) and had a mean age of 44.5 years and a mean left ventricle ejection fraction of 40.3%. Genetic testing identified mutations in various genes, predominantly TMEM43 (11%). In two patients (3%) with arrhythmogenic cardiomyopathy, complete subcutaneous defibrillator extraction with de novo transvenous implantable cardioverter-defibrillator implantation was needed. The absence of multiple associations among severe gene mutations was crucial for cardiac resynchronization therapy response. Mortality in this group was around 3% in titin dilated cardiomyopathy patients. Conclusions: Integration of genetic testing into the decision-making process for patients with electronic devices represents a paradigm shift in personalized medicine. By identifying genetic markers associated with arrhythmia susceptibility, heart failure etiology, and cardiac resynchronization therapy response, clinicians can tailor device choices to optimize patient outcomes.