Cardiac Implantable Devices Research Articles

Angle Dependence of Electrode Lead-Related Artifacts in Single- and Dual-Energy Cardiac ECG-Gated CT Scanning-A Phantom Study.

Background: The electrodes of implantable cardiac devices (ICDs) may cause significant problems in cardiac computed tomography (CT) because they are a source of artifacts that obscure surrounding structures and possible pathology. There are a few million patients currently with ICDs, and some of these patients will require cardiac imaging due to coronary artery disease or problems with ICDs. Modern CT scanners can reduce some of the metal artifacts because of MAR software, but in some vendors, it does not work with ECG gating. Introduced in 2008, dual-energy CT scanners can generate virtual monoenergetic images (VMIs), which are much less susceptible to metal artifacts than standard CT images. Objective: This study aimed to evaluate if dual-energy CT can reduce metal artifacts caused by ICD leads by using VMIs. The second objective was to determine how the angle between the electrode and the plane of imaging affects the severity of the artifacts in three planes of imaging. Methods: A 3D-printed model was constructed to obtain a 0-90-degree field at 5-degree intervals between the electrode and each of the planes: axial, coronal, and sagittal. This electrode was scanned in dual-energy and single-energy protocols. VMIs with an energy of 40-140 keV with 10 keV intervals were reconstructed. The length of the two most extended artifacts originating from the tip of the electrode and 2 cm above it-at the point where the thick metallic defibrillating portion of the electrode begins-was measured. Results: For the sagittal plane, these observations were similar for both points of the ICDs that were used as the reference location. VMIs with an energy over 80 keV produce images with fewer artifacts than similar images obtained in the single-energy scanning mode. Conclusions: Virtual monoenergetic imaging techniques may reduce streak artifacts arising from ICD electrodes and improve the quality of the image. Increasing the angle of the electrode as well as the imaging plane can reduce artifacts. The angle between the electrode and the beam of X-rays can be increased by tilting the gantry of the scanner or lifting the upper body of the patient.

Remotely monitored physical activity from older people with cardiac devices associates with physical functioning

IntroductionAccelerometer-derived physical activity (PA) from cardiac devices are available via remote monitoring platforms yet rarely reviewed in clinical practice. We aimed to investigate the association between PA and clinical measures of frailty and physical functioning.MethodsThe PATTErn study (A study of Physical Activity paTTerns and major health Events in older people with implantable cardiac devices) enrolled participants aged 60 + undergoing remote cardiac monitoring. Frailty was measured using the Fried criteria and gait speed (m/s), and physical functioning by NYHA class and SF-36 physical functioning score. Activity was reported as mean time active/day across 30-days prior to enrolment (30-day PA). Multivariable regression methods were utilised to estimate associations between PA and frailty/functioning (OR = odds ratio, β = beta coefficient, CI = confidence intervals).ResultsData were available for 140 participants (median age 73, 70.7% male). Median 30-day PA across the analysis cohort was 134.9 min/day (IQR 60.8–195.9). PA was not significantly associated with Fried frailty status on multivariate analysis, however was associated with gait speed (β = 0.04, 95% CI 0.01–0.07, p = 0.01) and measures of physical functioning (NYHA class: OR 0.73, 95% CI 0.57–0.92, p = 0.01, SF-36 physical functioning: β = 4.60, 95% CI 1.38–7.83, p = 0.005).ConclusionsPA from cardiac devices was associated with physical functioning and gait speed. This highlights the importance of reviewing remote monitoring PA data to identify patients who could benefit from existing interventions. Further research should investigate how to embed this into clinical pathways.

Impact of Immunosuppressive Therapy on Lead Dislodgement After Cardiac Implantable Electronic Device Implantation.

Lead dislodgement is a severe complication in cardiac implantable electronic device (CIED) implantation. Inflammation after CIED implantation results in the development of adhesions between lead and tissues, resulting in the lead becoming fixed in the body. In patients with immunosuppressive therapy, however, adhesion is inhibited by anti-inflammatory effects. However, the association between lead dislodgement and immunosuppressive therapy has not been clarified. The purpose of this study was to investigate the association between lead dislodgement and immunosuppressive therapy. We hypothesized that lead dislodgement more frequently occur in patients with immunosuppressive therapy than those without. In total, 651 consecutive patients who underwent CIED implantation or lead addition (age, 76 ± 11 years; and males, 374 [58%], high voltage device, 121 [19%], lead addition 23 [4%]) were retrospectively enrolled. Immunosuppressive therapy was with regular steroids or immunosuppressants. Lead placement was guided by fluoroscopy, and active fixation leads were used. Restraint of the upper limb by chest tape was performed for 1 week after the procedure. Lead dislodgement was defined as a change in lead position and/or lead failure requiring reoperation. Twenty (3.1%) patients received immunosuppressive therapy. Among these, 15 (2.3%) patients regularly took steroids and 8 (1.2%) took immunosuppressants. Lead dislodgement occurred in 10 (1.5%) patients. Lead dislodgement was more frequent in patients with immunosuppressive therapy than in those without (3 [15%] vs. 7 [1%], p = 0.003). In patients with CIED implantation or lead addition, lead dislodgement is more frequent in patients with immunosuppressive therapy than in those without.

Near-zero fluoroscopy technique for cardiac electronic device implantation: long-term outcomes

Abstract Introduction Radiation hazards are a major concern for both patients and staff. We have previously described a near-zero fluoroscopy technique for cardiac electronic device implantation. In this study, we aimed to investigate the long-term safety of this technique and compare outcomes and procedural metrics with a conventional approach in a larger population. Methods Low-dose fluoroscopy technique. Radiation exposure during fluoroscopy is directly proportional to the time the unit is activated. Typically, the pedal switch is depressed for at least a few seconds per imaging sequence in order to visualize "live" movements of either the leads during their positioning or the needle during a fluoroscopy-guided puncture of the subclavian vein. Our technique consists of setting a low frame rate per second (0.5-3.75fps) and momentarily triggering the foot pedal switch only to obtain screenshots of the position of the leads/needle. Use of live electrograms to assist spatial awareness of lead position (e.g. Atrial, Coronary Sinus, Ventricular signals) acts as an adjunct to guidance. Study design We included consecutive patients undergoing permanent pacemaker (PPM) or cardiac defibrillator (ICD) implant at our center from July 2018 to December 2022 using the near-zero fluoroscopy technique. Procedures were performed by three operators (AC, MD, MF). Cumulative radiation dose was measured using dose-area product (DAP). We assessed procedure success and complication rate during long-term follow-up. We compared the procedural metrics and outcomes with a cohort of patients with PPM or ICD implanted in our centre by senior operators, using a traditional fluoroscopic approach. Propensity score was adopted to match baseline characteristics between the study and control group. Results The total population consisted of 412 patients (74.2±13.9 years, 60.9% male). We included 206 who underwent PPM or ICD implantation using the low-dose fluoroscopy technique, and 206 matched-control. A PPM or ICD was successfully implanted in all patients. Fluoroscopy time and DAP were significantly lower in the low-dose fluoroscopy group, mean 2.3±2.0 seconds versus 258.4±252.1 seconds (P<0.001) and 3.4±3.5 µGym2 versus 29.8±55.4 µGym2 (P<0.001), respectively. Mean procedure time was 49.0±20.8 minutes in the low fluoroscopy group and 65.7±26.8 minutes in the control group (P<0.001). Median frame per second setting was 0.5 in the low-dose cohort. After a mean follow-up of 441±470 days, the rate of complications was identical across groups (2.4%, p = 1.0). Conclusion This near-zero dose fluoroscopy technique is effective and safe, enabling a 10x reduction in radiation exposure during device implant. Modification of traditional implant and imaging techniques can provide material reductions in fluoroscopy dose to even below that for a standard PA chest radiograph.

Impact of taurolidine use during cardiac electronic implantable device implantation in heart failure patients

Abstract Background Cardiac Implantable Electronic Device (CIED) infections represent a critical health threat with potentially fatal consequences. The TauroPace™ is an innovative solution that contains taurolidine specifically formulated to eradicate environmental microbial contamination on the surface of CIEDs. To date, scarce data are available in literature about Taurolidine’s effect on preventing CIED infections. Aims To investigate the ability of the TauroPace™ to reduce major CIED infections through 12 months follow-up in fragile patients such as heart failure (HF) patients. Methods This prospective cohort study included patients with HF and an ejection fraction ≤ 35%, who were referred for de novo implantation, upgrading or battery replacement of Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy with defibrillator (CRT-D), to the EP labs of two tertiary care hospitals. Patients with previous CIED infections were excluded. During the procedures, the catheters were submerged in the TauroPace™ solution and the pocket was irrigated with taurolidine. Starting from the main risk factors for the development of CIED-related infections as identified in the literature (including individuals with heart failure, diabetes, chronic kidney disease, and those undergoing defibrillators implantation, especially upgrades or revisions procedure), we conducted a meta-analysis and meta-regression to evaluate the relationship between the treatment effect's magnitude and various predictors. To estimate the incidence of CIED infections in high-risk subgroups, we utilized the percentage of patients with diabetes, chronic renal failure, or those undergoing replacement, upgrade, or revision procedures, along with other risk factors for CIED infections, as continuous variables and we were able to modify our comparison parameters based on the real percentage of risk factors that we obtained. Results The study included 69 consecutive patients (53 male [76.8 %], 34 ischemic [49,3 %], median [IQR] age 68 [59-73] years, 19 diabetic [27.5 %] and 34 [49.2 %] with chronic renal failure), of whom 39 (56.5 %) received ICD and 30 (43.5 %) CRT-D, with 28 (40.6 %) replacement procedures, 2 (2.9 %) upgrades, and 39 (57%) de novo implantations. During the one-year follow-up period, 1 [1.45 (Standard Error, SE 0.014) %] patient undergoing a CRT replacement developed an infection. The available data from the literature estimate an incidence rate of 6% (SE 0.0106) when considering a selected patient population with a very high risk of infection similar to our population. This is significantly higher than our cohort (z-score -2.5447, p value = 0.011). Conclusions Taurolidine has yielded promising results, demonstrating a low incidence rate of infections within our cohort of high-risk patients, which is below that reported in the literature. Further data will be necessary to validate and confirm these initial findings.

Efficacy of Different Exercise Modalities in Patients with Implantable Cardiac Devices: A Systematic Review

Efficacy of Different Exercise Modalities in Patients with Implantable Cardiac Devices: A Systematic Review

Ablation of persistent atrial fibrillation based on atrial electrogram duration map: methodology and clinical outcomes from the AEDUM pilot study

Abstract Background Catheter ablation of persistent atrial fibrillation (PsAF) represents a challenge for the electrophysiologist and there are still divergences regarding the best ablative approach to adopt. Objectives Create a new map of the duration of atrial bipolar electrograms (Atrial Electrogram DUration Map, AEDUM) to recognize a functional substrate during sinus rhythm and guide a patient-tailored ablative strategy for PsAF. Methods 40 PsAF subjects were assigned in a 1:1 ratio to either for PVI alone (Group B1) or PVI+AEDUM areas ablation (Group B2). A cohort of 15 patients without AF history undergoing left-sided accessory pathway ablation was used as a control group (Group A). In all patients, voltage and AEDUM maps were created during sinus rhythm. The minimum follow-up was 12-months, with rhythm monitoring via 48-h ECG Holter or by implantable cardiac device. Results Electrogram (EGM) duration was higher in Group B than in Group A (49±16.2ms vs 34.2±3.8ms; p-value<0.001). In Group B the mean cumulative AEDUM area was 21.8±8.2cm2; no difference between the two subgroups was observed (22.3±9.1cm2 vs 21.2±7.2cm2; p-value=0.45). The overall bipolar voltage recorded inside the AEDUM areas was lower than in the remaining atrial areas [median:1.30mV (IQR:0.71–2.38mV) vs 1.54mV (IQR:0.79–2.97mV); p-value:<0.001)]. Low voltage areas (<0.5mV) were recorded in three (7.5%) patients in Group B. During the follow-up [median 511 days(376-845days)] patients who underwent PVI-only experienced more AF recurrence than those receiving a tailored approach (65% vs 35%; p-value=0.04). Conclusions All PsAF patients exhibited AEDUM areas. An ablation approach targeting these areas resulted in a more effective strategy compared with PVI only.AEDUM mapAEDUM map and lesion set

Remote monitoring is an independent predictor of better survival in patients with ischemic cardiomyopathy and implantable cardioverter-defibrillators

Abstract Introduction Despite improvements in pharmacotherapy and advancements in invasive techniques, patients with ischemic cardiomyopathy are at high risk of adverse events and death. Strategies aimed at improving prognosis, including patient-centered individualization of care are needed. Remote monitoring (RM) of patients with heart failure, which allows for a continuous assessment of device- and some patient-related parameters, has been shown to reduce the risk of hospitalization and death, although no analyses were focused specifically on patients with ischemic cardiomyopathy after percutaneous coronary intervention (PCI). Purpose To determine whether RM is associated with outcomes in patients with ischemic cardiomyopathy after percutaneous coronary intervention. Methods The clinical, echocardiographic and angiographic data of consecutive patients with ICM and ICD or CRT-D, who had undergone PCI were obtained from the single-centre COMMIT-HF registry. Each consecutive patient with ICM was offered RM at the discretion of the treating physician. The RM center in our facility monitors patients with cardiac implantable devices in all working days. In case of any clinical, or device-related events potentially requiring reaction, patients are telephonically invited to contact healthcare system, either in the local emergency departments, or in our hospital, or outpatient clinic. Patients supervised with RM undergo routine in-person visits in the outpatient device clinic every 12 months. In the conventional arm, routine visits in the outpatient clinic occur every 6 months. The long-term data were acquired from the National Health Fund – the sole Polish healthcare provider. The primary outcome of the study was 36-month all-cause mortality. Results In the years 2009-2017, there were a total of 1019 patients with ICM and ICD, who underwent PCI, and those constituted the study group. Of those, 227 (22.3%) were monitored remotely, while the remaining were treated conventionally. The studied groups did not differ significantly, apart from that the patients with RM had a history of CABG, and had a lower mean left ventricular ejection fraction (LVEF, 26% vs 32%, p<0.001) than subjects without RM, while the percentage of CRT-D devices was significantly higher in patients with RM (36.2% vs 6.2%, p<0.001). The 36-month all-cause mortality rate was 18.9% in patients monitored remotely and 25.3% in subjects without RM (p log rank = 0.028). In the multivariable analysis, RM was identified as an independent predictor of lower mortality. The other variables independently associated with higher survival were lower age, absence of anemia, optimal glomerular filtration rate, and higher LVEF. Conclusions Remote monitoring of patients with ischemic cardiomyopathy is independently associated with lower all-cause mortality in a real-world cohort of patients with ICDs.Baseline characteristicsMultivariable analysis

Feasibility and outcomes of ultrasound-guided transcutaneous access to the axillary vein for implantation, revision, and upgrade of cardiac electronic devices

Abstract Background Implanting leads for cardiac implantable electronic devices (CIED) requires venous access. Venous access is commonly established through the cephalic and subclavian vein. For CIED upgrades or revisions, the preferred cephalic vein access is often not viable. Several reports suggest that fluoroscopy-guided axillary vein puncture may reduce thoracic complications. Purpose This study reports on procedural outcomes of ultrasound-guided axillary vein access for CIED implantation, revision, or upgrade in a large tertiary care centre. Outcomes were compared to the traditional subclavian vein approach. Methods This retrospective, single-center non-randomized study, conducted from January 2021 to August 2023, analyzed patients undergoing CIED implantation, revision, or upgrade. Axillary access, initially introduced by one operator, was increasingly adapted by additional operators. The axillary access was obtained by ultrasound-guided visualization of the axillary vein at the deltopectoral groove (Figure 1A and B). Subsequently, the wire(s) were transcutaneously inserted. An adjacent skin incision allowed for threading the wire(s) followed by standard lead implantation (Figure 1C). The study evaluated the acute success of each venous access method and the incidence of adverse events. Those were defined as pneumothorax, hemothorax, and pocket hematoma. An intention-to-treat analysis was performed. A p-value assessed the comparative outcomes between the axillary and subclavian access methods. Results In this study, 986 patients (mean age 74, IQR 64-82 years, 35% women) underwent CIED implantation, revision, or upgrade with 1636 lead implants. Axillary access was used in 578 patients with 532 (92%) successful implantations. Subclavian access yielded a higher success rate with 394/408 patients (97%) (p=0.003). For device upgrades or revisions specifically, axillary access was successful in 68/79 patients (86%), versus 44/47 patients (94%) with subclavian access (p=0.193). Acute complications were less frequent with axillary access (0.3%, 2/578 patients) and consisting of two cases of pneumothorax requiring intervention. In CIED implantations via subclavian access, complications occurred in 17/408 patients (4.2%) (p<0.001) including pneumothorax in 12 patients (2.9%, with 2% requiring intervention), hemothorax in three patients (0.7%), and pocket hematoma in two patients (0.5%). No additional complications were observed in the axillary group. Conclusion The implementation of transcutaneous, ultrasound-guided axillary access for CIED implantations, revisions and upgrades in a major CIED training centre is feasible. Complication rates were low compared to subclavian venous access.Figure 1

Investigating long-term outcomes and predictors of primary outcomes in patients treated for cardiac implantable electronic device infections

Abstract Background The estimated current infection rate after cardiac implantable electronic devices (CIED) implantation ranges between 1% and 2%, with variations in the literature from 0.13% to 12.6% (2). The rise in CIED implantation rates over the years has led to an escalation in the frequency of device-related infections. This trend is compounded by the elongation of patient comorbidities and life expectancy (3). Purpose The study aimed to investigate the primary outcome rates (including death, myocardial infarction (MI), cerebrovascular accidents (CVA), and reinfection) and identify predictors of primary outcomes in patients receiving treatment for CIED infection. Methods A retrospective analysis was conducted at a single-center. The study encompassed 2322 patients who sought treatment at the arrhythmia clinic of our Institute between March 2011 and July 2020 and underwent CIED implantation. After excluding 20 patients with active infections and 3 patients postoperative cardiac arrest, 36 patients were diagnosed with CIED infection (1.55% incidence). Diagnosis was based on the Novel 2019 International CIED Infection Criteria. Patients were categorized into groups based on the occurrence of all-cause death, MI, CVA, and reinfection during the follow-up period. Results The median follow-up period post admission with CIED infection was 42.5 (7-141) months. Table 1 presents patient characteristics, procedure details, and management-related parameters in the groups stratified by the primary endpoint. Notably, 58.3% of the patients had previously undergone a replacement procedure. Among patients with CIED infection, reinfection was observed in 20.0% of those who had a de novo procedure and 38.1% of those who underwent a secondary procedure (p: 0.25). Cox regression analysis revealed that pre-procedure C-reactive protein (CRP) levels and CHA2DS2-VASc score were independent predictors of the primary outcome (OR: 1.03 (1.00-1.06); P: 0.035, OR: 1.34(1.03-1.88); P: 0.030, respectively) (Table 2). Conclusion Long-term outcomes in patients with CIED infection appear to be correlated with pre-procedure CRP levels, indicating the severity of infection, and the CHA2DS2-VASc score, providing valuable insights into patient comorbidities. These factors seem to outweigh the impact of the specific procedure and antibiotic regimens administered. Management should not only focus on the history of CIED infection during follow-up but also prioritize the management of existing comorbidities to improve outcomes. Given the study's limitations such as the small sample size and retrospective nature, further investigations are warranted to confirm these findings.Table 1Table 2

Severe lead induced tricuspid regurgitation - clinical impact of repair or replacement of tricuspid valve

Abstract The prevalence of lead-induced tricuspid regurgitation (LITR) ranges between 7 to 45%. The most frequent mechanism of LITR is the impingement of the leaflets, but right ventricle remodelling, pacing-induced cardiomyopathy and tricuspid annular dilatation also can contribute to the severity of tricuspid regurgitation (TR). Different studies concluded that LITR was associated with an increased risk of all-cause mortality and heart failure hospitalizations. Beyond diuretics, patients (P) may be candidates for interventional treatment, including lead extraction, surgery, or percutaneous tricuspid trans-catheter ‘edge-to-edge’ repair (TEER) and heterotopic bicaval devices (HBD). Despite its importance, there is a scarcity of data concerning the management and clinical impact of severe LITR. The purpose of the current analysis is to improve the knowledge regarding the impact of interventional treatment on the outcomes in this population. Methods A retrospective, single-centre analysis was made including P with severe LITR referred to evaluation regarding eligibility for tricuspid percutaneous intervention in a tertiary hospital. All P were evaluated using both transthoracic echocardiography (TTE) and transoesophageal echocardiography (TEE). Data were collected regarding clinical characterization, management, intervention and follow-up. Results From January 2020 to September 2023, of the 97 P referred for tricuspid intervention eligibility, 36 (37%) had LITR, with 14 cases (39%) presenting lead impingement as the TR mechanism. The majority of P were female (58%), with a median age of 78 [IQR 72-83] years. Median Euroscore II was 6 % [IQR 3-9]), with 51% of the P having a previous heart surgery, and 97% presenting atrial fibrillation. Prior to cardiac electronic device (CIED) implantation, 14% already presented TR. When analysing post-CIED TR, 30% increased 1 grade of TR at 1-year follow-up, and 68% increased 2 grades of TR at 5 years. According to TTE, ventricular desynchrony was present in 30% of the P. After evaluation of TR, 30% underwent intervention (22% percutaneous - TEER or HBD - and 8% surgical). All P remained with the previous electrodes. Mortality was 21.1% in the intervention population and 78.9% on the remaining pts (p=0.027). The type of intervention had no statistically significant differences in outcome. Conclusions In our study, more than 1/3 of the cases referred due to severe TR presented lead impingement as the mechanism underlying TR. As previously reported, the intervened population had better outcomes than the remaining pts.

In-hospital mortality following catheter ablation procedures in Germany: insights from the VARY project

Abstract Background The number of catheter ablation (CA) procedures has increased significantly over the last decade. 102,737 CA have been performed in Germany in 2021. Although CA of different types of arrhythmias is generally considered to be safe, serious complications, including in-hospital death, may occur. There is a paucity of real-world national healthcare data in Germany. Aim To investigate the overall in-hospital mortality in patients undergoing any type of CA procedure in Germany and to identify variables associated with in-hospital mortality. Methods According to the German law German hospitals are obliged to provide a dataset including case data, diagnosis based on the ICD-10-GM, operational and procedural codes to the Institute for hospital remuneration system (InEK) every year. The VARY project aims at analyzing and monitoring these data to report the real world scenario on patients undergoing CA in Germany. As of now, 22 German centers were contacted by the Institute for Myocardial Infarction Research (IHF). Their Data between 2019 and 2023 provided from seven of those centers were used for this analysis. Datasets from ten centers are pending. Five centers were not able to provide their data. The project is supported by the German Heart Foundation. Results A total 21,028 patients underwent inpatient CA. 49 patients (69.4% males) died in-hospital following a CA procedure resulting in an overall in-hospital mortality rate of 0.23%. A percutaneous epicardial ablation approach was used in 6.1% of the patients who died (Group A) compared to 0.3% in the surviving patients (Group B). Radiofrequency ablation was used in 83.7% vs. 72.6%, cryoablation in 10.2% vs 27.1%. Patients who died were older compared to those who survived (mean age: 66.7 ± 14.6 vs. 62.0 ± 14.4 years, p <0.01) and had more comorbidities such as diabetes (19/49 (38.8.%) vs. 2274/20,979 (10.8%), p <0,01), chronic obstructive pulmonary disease (5/49 (10.2%) vs. 555/20,979 (2.6%), p < 0,01) and heart failure (39/49 (79.6%) vs. 5116/20,979 (24.4%), p <0.01). There was no difference with regards to gender between the two groups. The most common arrhythmia in both groups was atrial fibrillation with 67.3% and 75.3% (p < 0.01). Cardiac arrest was observed in 44.9% of patients in group A compared to only 0.3% in group B. The median hospital stay was longer in group A (19.0 (IQR 8.0; 42.0) vs. 2.0 (IQR 1.0; 3.0), p < 0.01). 46/49 (93.9%) patients who died were treated on an intensive care unit for a median time of 13.5 days (IQR 3.8; 33.8) compared to 1272/20,979 (6.1%) (p < 0.01) in group B. A cardiac implantable electronic device implantation or revision was performed in 18.4% patients in group A (4 defibrillator implantations, 2 pacemaker implantations, 5 revisions) compared to 2.9% in group B (survivors). Conclusion Inpatient catheter ablation procedures in Germany are associated with a very low in-hospital mortality comparable to data reported from the US.

Risk factors for asymptomatic bacterial colonization of cardiac implantable electronic devices

Abstract Introduction With broadening indications and a progressively ageing demographic, incidence of cardiac electronic implantable device (CIED) implantation increased. Despite device infection being rare, it persists as a serious complication concomitant with a high mortality rate. While extensive research on cardiac device infection (CDI) has been conducted, the incidence and clinical significance of asymptomatic bacterial CIED colonisation has not been investigated so far. Purpose Our study aims to elucidate potential risk factors for and investigate the clinical significance of asymptomatic bacterial CIED colonisation. Methods and Results In this prospective single centre study, 345 patients with no clinical signs of CIED infection underwent a generator exchange. In total, 78 pacemakers (PM), 97 implantable cardiac defibrillators (ICD), 67 cardiac resynchronisation therapy devices (CRT), 1 baroreceptor stimulator, as well as 102 implantable loop recorders were sonicated to determine the presence of adherent microorganisms (biofilms). Intraoperative swabs were collected in 329 patients. For statistical analysis, detection of ≥1 colony forming units (CFU) during sonication was considered a significant level of bacterial colonisation. The ≥50 CFU threshold was established in order to examine risk factors relevant for higher levels of bacterial colonization. 88 CIED (25.5%) showed bacterial colonisation ≥1 CFU while 44 CIED (12.8%) were colonised with ≥50 CFU. Multivariate analysis revealed male gender as independent risk factor for both ≥1 CFU (p<0.001; OR 7.73, CI 2.84-21.04) and ≥50 CFU (p<0.001; OR 12.14, CI 2.79-52.78). and immunosuppressive medication (p=0.018; OR 3.31; CI 1.23-8.92) as independent risk factor identified for ≥50 CFU colonisation. For both cutoffs, Cutibacterium acnes emerged as the most frequently detected bacterium during sonication, followed by coagulase negative Staphylococci (CoNS) with Staphylococcus epidermidis being the most common within this CoNS group. During the follow-up (384.5 +/- 480.6 days), 287 patients showed absence of CDI (53 patients lost to follow-up). Of the five patients with CDI, one exhibited concordant results between sonication, swab, and blood culture for Cutibacterium acnes, one presented with partially concordant results, whereas the other three showed varying degrees of disconcordance between index event microbiological results and subsequent CDI pathogens. Conclusion Remarkably, 27.2% of CIEDs with leads (PM, ICD, CRT) exhibited bacterial colonisation. Out of the 5 CDIs identified, 4 were associated with positive sonication results. In addition, our study identifies male gender and immunosuppressive medication as significant risk factors for asymptomatic bacterial CIED colonisation. Thus, in patients with these given risk factors, CIED sonication should be considered for risk stratification with regard to a subsequent CIED infection and possible targeted antimicrobial therapy.Flow Chart

Transfemoral leadless pacemaker implantation after tricuspid valve surgery and intervention

Abstract Background and Purpose Pacemaker (PM) implantation after surgical or transcatheter tricuspid valve (TV) repair or replacement may be challenging. Transcatheter leadless pacemaker (LPM) implantation has become a routine procedure and is frequently adopted in patients without the need for an atrial lead, in cases with cardiac implantable device infection or in patients with marked comorbidities. The use of LPM in patients with previous TV repair or replacement has only been described in singular cases in literature. We present our single center experience of LPM implantation after TV repair. Methods Patients with a history of TV repair or replacement who underwent LPM in our institution between 01/2020 and 11/2023 were retrospectively analyzed. All patients underwent routine clinical follow-up investigations including LPM interrogation and transthoracic echocardiography to assess for TV status. For LPM implantation right anterior oblique (RAO) and left anterior oblique (LAO) caudal fluoroscopy projections were utilized to enable LPM device passage across the TV. Results The study population consisted of 10 patients (9 females, mean age 74.0±10.0 years). Two patients had a history of surgical TV annuloplasty repair and two patients a history of surgical valve replacement, four patients of transcatheter TV repair (one through the mitral clip), one patient of transcatheter valve-in-ring bio prosthesis implantation prosthesis after previous surgical ring deployment and one patient transcatheter TV replacement (Figure1). All patients suffered from permanent atrial fibrillation previous to implantation procedures. Three patients were on chronic hemodialysis therapy before LPM implantation. LPM systems were successfully implanted in all cases with a mean procedure time of 43.5±26.5 minutes and a mean fluoroscopy time of 5.9±5.5 minutes and a radiation dose of 1148,7±1424,9 cGy·cm2. For fluoroscopically guided TV crossing a mean LAO angle of 43.6±14.1° (range 22 to 53°) and caudal angle of 8.5±6.9° (range 0 to 20°) was utilized (Figure 2). The LPM device was positioned in the first positioning attempt in a right ventricular high septal localization in 8 cases. Mean pacing threshold was 0.36±0.07 V at 0.25 ms, with a mean sensing amplitude of 10.5±2.9 mV and a mean of 853±324 Ohms pacing impedance. No periprocedural complications occurred. Mean duration of follow-up was 8.1±9.2 months. There were no newly developed TV regurgitations noted. Pacing thresholds (0.37±0.1 V/0.25 ms), sensing amplitude (11.8±4.5 mV) as well as pacing impedances (865±365 Ohms) remained stable until the last follow-up investigation. Conclusion LPM implantation was feasible in patients with a history of TV repair or replacement. LPM implantation was safe and effective in various modalities of TV repair. LPM may be an alternative to conventional pacemaker implantations as well as surgical lead placement in selected patients.Figure 1.Figure 2.

MAGNETIC RESONANCE AND CARDIAC IMPLANTABLE DEVICES: A SAFE COMBINATION

Abstract Despite guidelines the presence of a cardiac implantable device (CIED) in a magnetic resonance (MR) ambient raises fears and perplexities and generates the often inappropriate request for support from the electrophysiologist. From January 2019 to November 2023 all patients with a cardiac implantable device (CIED) undergoing magnetic resonance (MR) were evaluated. All CIEDS were classified into three subgroups: MR–conditional, MR–unsafe and "non MR–conditional" (catheters and generators MR–conditional but of different manufacturers). No implantable loop recorders were enrolled. We performed a device control immediately before and after the RM procedure. We analyzed the percentage variations of each parameter (sensing, impedance and pacing threshold) pre– and post–MR and the variation versus the latest or the subsequent ambulatory control. 151 patients were proposed to undergo MR. 16 patients underwent multiple exams. The districts explored from RM were head (47%), column (21%), breast (1%), heart (3%), abdomen (20%), prostate (2%) and arms (16%). The median age was 70 years old, and 102 patients were males. CIEDS were pacemaker in 67% (3 leadless and 1 CRT–P), 33% defibrillators (5 S–ICD and 10 CRT–D). 85% of the systems were classified as MR–conditional, 3% as MR–unsafe and 12% as "non MR–conditional". The percentage median variation of atrial and ventricular sensing, impedance and threshold during the exam was 0%. MR did not significantly modify the parameters considered. No adverse events arise at the end of MR or in the days after. In our experience, there is no need for the presence of the electrophysiologist during the procedure due to safety even in "non MRI–conditional" or MR–unsafe patients.

MANAGEMENT OF REMOTE MONITORING FOR IMPLANTABLE DEVICES CONTROLS: SINGLE CENTER EXPERIENCE

Abstract Background Nowadays the benefits of remote monitoring (RM)of cardiac implantable electronic devices (CIEDs) are Known: an improved both device surveillance and patient clinical management and a decrease in office follow up. So RM is used as supplement in clinic follow up for patients with CIED.However despite decades to RM utilization there are challenges in managing patients with RM including large number of trasmissions and lack of trained staff. There are many different model of care to RM management. Methods We describe our model of care to management CIED recipients with RM considering data collected from January 2021 to November 2023. Results Our model of care consists of 4 electrophysiologists Physicians and 4 Tecnicians. RM enrollment is performed at scheduled in office visit after ten days from hospital discharge after device implantation. implantable cardiac device(ICD)recipients with RM are annualy followed in office and biennal for pacemaker (PM) recipients and they send every three months transmissions. Trained tecnicians gives home monitor, take care of patients education and collected and screen transmissions. Tecnicians inform immediately physicians in case of urgent alert (shock or antitachicardia pacing therapy (ATP), sustained ventricular tachycardia(TV), ventricular fibrillation (Fv) indicator of elective replacement (ERI), lead releted alert or noise). Physician contact patients the same day (exept Saturday and Sunday). In addiction Physicians twice a week review less urgent and scheduled transmissions and call the patients by phone for visit in office for patients with low rate of biventricular pacing, detection of atrial fibrillation. We have 1000 patients with RM: 746 ICD recipients (103 Biotronik, 150 Abbott, 200 Boston scientific, 293 medtronic), 50 implantable cardiac monitor (ICM) recipients and 204 PM recipients. We analyze 12721 transmissions.Considering ICD recipient we detect 96 episode of ATP and 31 of shock. Shock of ICD was registered in 52 patients (6,9%)We received 1982 atrial fibrillation (AF) detection, with 35 for new detectable AF.The most of transmisisone were for low bIV pacing. We contacted these patients by phone about clinical status and in some case we called them in office. Conclusions Our model of care allows to control a large number of trasmissions with fast management of urgent alert trasmissions.

INFECTIOUS ENDOCARDITIS, ITS CHALLENGES AND UPDATING THE DUKE CRITERIA: A LITERATURE REVIEW

Infective endocarditis (IE) is an inflammatory process that occurs in the endocardium and also in implantable cardiac devices, the septum between the heart chambers, and in particular the heart valves, whether biological or prosthetic, this process comes from infection by some microorganism, especially bacteria. In 2023, the International Society of Cardiovascular Infectious Diseases (ISCVID) reformulated the diagnostic criteria, in particular those related to microbiological aspects. The aim of this study is to discuss the modified Duke criteria, therapeutic measures, and future challenges. The present study is a narrative bibliographical review that analyzed scientific production in online databases. Because it is a rare pathology, its annual incidence is between 3 and 10 cases per 100,000 people, and it is twice as common in males. Its treatment is complex, but its mainstay is antibiotic therapy and, when necessary, cardiac surgery. Empirical antibiotic treatment should be carried out as soon as possible after blood culture tests have been taken. In conclusion, IE is one of the most laborious and difficult medical conditions for physicians to practice, so it is important to employ a systemic approach based on scientific evidence for diagnostic investigation and therapeutic care for good results and patient well-being.

Implantable Cardiac Devices in Patients with Brady- and Tachy-Arrhythmias: An Update of the Literature.

Implantable cardiac devices are a vital treatment option in the management of tachy/brady-arrhythmias and heart failure with conduction disease. In the recent years, these devices have become increasingly sophisticated, with high implantation success rates and longevity. However, these devices are not without risks and complications, which need to be carefully considered before implantation. In an era of rapidly evolving cardiac device therapies, this review article will provide an update on the literature and outline some of the emerging technologies that aim to maximise the efficiency of implantable devices and reduce complications. We discuss novel pacing techniques, including alternative pacing sites in anti-bradycardia and biventricular pacing, as well as the latest evidence surrounding leadless device technologies and patient selection for implantable device therapies.

Treatment with cardiac electronic implantable devices

Cardiac device therapy provides not only treatment options for bradyarrhythmia but also advanced treatment for heart failure and preventive measures against sudden cardiac death. In heart failure treatment it enables synergistic reverse remodelling and reduces pharmacological side effects. Cardiac resynchronization therapy (CRT) has revolutionized the treatment of reduced left ventricular ejection fraction (LVEF) and left bundle branch block by decreasing the mortality and morbidity with improvement of the quality of life and resilience. Conduction system pacing (CSP) as an alternative method of physiological stimulation can improve heart function and reduce the risk of pacemaker-induced cardiomyopathy. Leadless pacers and subcutaneous/extravascular defibrillators offer less invasive options with lower complication rates. The prevention of infections through preoperative and postoperative strategies enhances the safety of these therapies.

Prevention and Risk Assessment of Cardiac Device Infections in Clinical Practice.

The implantation of cardiac electronic devices (CIEDs), including pacemakers and defibrillators, has become increasingly prevalent in recent years and has been accompanied by a significant rise in cardiac device infections (CDIs), which pose a substantial clinical and economic burden. CDIs are associated with hospitalizations and prolonged antibiotic therapy and often necessitate device removal, leading to increased morbidity, mortality, and healthcare costs worldwide. Approximately 1-2% of CIED implants are associated with infections, making this a critical issue to address. In this contemporary review, we discuss the burden of CDIs with their risk factors, healthcare costs, prevention strategies, and clinical management.