Cardiac Implantable Electronic Devices Research Articles

Incidental non-infectious masses on cardiac implantable electronic device leads

Abstract Introduction Incidentally detected masses on the leads of cardiac implantable electronic devices (CIED) present a clinical challenge, raising suspicion of infective device endocarditis. Data on the prevalence of such findings are scarce and outdated. Purpose Our aim was to determine the prevalence and evaluate predisposing clinical factors of incidental non-infectious CIED lead masses during transoesophageal echocardiography (TOE). Methods In this retrospective single-centre study, we analysed all TOE examinations performed in patients with CIED leads between January 2010 and November 2023. Patients with suspected or confirmed infectious endocarditis were excluded from this study. Patients with and without incidental non-infectious lead masses were compared regarding clinical characteristics, anticoagulation, type of CIED, and indication for TOE. Results In total, 120 patients with CIED were included. Twenty-five patients (20,8%) presented with non-infectious CIED lead masses. Laboratory findings and cardiovascular risk factors, such as arterial hypertension, dyslipidaemia, diabetes mellitus or chronic kidney disease did not differ significantly between both groups. Moreover, no association was observed between the incidence of CIED lead masses and the type of CIED implanted. Of notice, patients without therapeutic anticoagulation had significantly higher prevalence of CIED lead masses (OR 2.59, 95% CI: 1.04-6.46.; p=0.02), whereas the distribution of CHA2DS2-VASc scores did not differ significantly between both groups. Conclusion Non-infectious CIED lead masses in TOE is a frequent incidental finding. The absence of the oral anticoagulation seems to be the only clinical risk factor for such finding in our study, suggesting possible thrombogenic etiology. The high prevalence of incidental non-infectious lead masses should be kept in mind in order to avoid overdiagnosis of CIED infection and unnecessary lead extraction.

Lead-related tricuspid regurgitation: an important phenotype seen through the lens of computed tomography

Abstract Background The imaging diagnostic approach of patients with cardiac implantable electronic devices (CIED)-related tricuspid regurgitation (TR) is undefined. Functional cardiac computed tomography angiography (4D-CTA) provides a complementary role to echocardiography in the evaluation of tricuspid valve (TV) apparatus and right ventricle (RV) remodeling, but the capability to assess lead-leaflet interaction is unknown. Purpose To evaluate the role of 4D-CTA anatomical and morphological diagnostic assessment in a cohort of patients with severe TR and CIED vs those without. Methods Clinical, echocardiographic and CTA data were collected from two quaternary centers for patients with severe TR and a CIED evaluated between January 2017 to October 2023. Functional and morphological CTA information assessed lead-leaflet relationship to divide patients in those with lead-related TR, those with no lead-TR causal relationship, and those with severe isolated TR but without CIED. Primary end-point was the occurrence of all-cause death. Results A total of 143 patients were identified, roughly dividng the cohort into thirds. Baseline characteristics and imaging characteristics of these 3 groups revealed important differences suggesting a more advanced patophysiology phenotype for those with lead-related TR, particularly presenting both the largest 4D-CTA-derived TV maximum coaptation gap and anatomical regurgitant orifice area (see Figure 1). At regression analysis, time from CIED implantation (OR 1.01, CI 1.00-1.09, p=0.031) and >3 leaflets valve morphology (OR 2.90, CI 1.01-8.32, p=0.040) were independently associated with lead-related TR. After a median follow-up of 18 months, the primary end-point occurred in 36 patients (25%) and was more common among patients with lead-related TR (p-value overall= 0.007, see Figure 2). While no differences in the rate of TV intervention were found, excessive mortality persisted for lead-related TR group even after adjustement for age and gender (HR 6.49, CI 1.72-14.47, p=0.006). Conclusion Systematic 4D-CTA in patients with severe TR and presence of a CIED, identified a large number of patients with lead-related TR with important functional and anatomical implications including greater TR severity and > 3 leaflets. These findings appear to have prognostic relevance that might have decision-making implications for patient management.Figure 1Figure 2

Identifying at-risk patients for atrial high-rate episodes by machine learning

Abstract Background Current evidence suggests that atrial high rate episodes (AHRE)/subclinical atrial fibrillation (AF) are associated with increasing risk of clinical AF, and subsequently, ischaemic stroke and other adverse cardiovascular events. Purpose To construct a high-performance model by machine learning (ML) for the prediction of AHRE detected by a cardiac implantable electronic device (CIED) capable of atrial sensing in a European cohort. Methods We utilized data from a prospective cohort of patients with CIED. AHRE was defined as an episode lasting at least 5 minutes with atrial rate ≥ 175 beats per minute. We divided the cohort into training and internal validation cohorts in 7:3 and used 5-fold cross-validation in the training cohort to assess model performance and prevent model overfitting. Pre-selected features were imported into eight common ML algorithms to predict AHRE, including light gradient boosting machine (LightGBM), random forest (RF), logistic regression, support vector machine, multiple perceptron, eXtreme gradient boosting machine (XGBoost), Gaussian naïve Bayes, and K nearest neighbours. The importance ranking of the features was interpreted by calculating the SHapley Additive exPlanationation (SHAP) value for each feature within the optimal model. Results A total of 500 consecutive patients with CIEDs (mean age 70.2±13.3; 39.2% female) were included. Of these, 164 patients (32.8%) were found to have AHRE. Among all ML models, RF was the best performing model, which obtained the highest AUC (0.738), recall (0.673) and F1-score (0.584) in the internal validation cohort. The results of SHAP showed that antiplatelet, statin, age, white blood cell count, and cardiomyopathy were the first five important features, indicating that the RF model had good interpretability and reliability. Conclusion Our study is the first to demonstrate in a European cohort the effectiveness and feasibility of ML algorithms in predicting AHRE in patients detected by CIEDs. The best RF models require further external validation to assess generalizability to other cohorts.Figure 1Figure 2

Relapse of infective endocarditis after cardiac implantable electronic device removal compared to a conservative strategy

Abstract Background According to current guidelines, complete removal of cardiac implantable electronic device (CIED) should be considered in patients with valvular infective endocarditis (IE), accounting for the identified pathogen and need for valve surgery (Class IIa recommendation). Unselected longitudinal data are needed to assess this strategy. Purpose To examine IE readmission after IE discharge according to status of CIED removal in patients with conservatively treated IE. Methods Using Danish nationwide registries, we identified patients aged ≥18 years with first-time IE from 2010-2021. We included patients with conservatively treated IE and a CIED, who were alive at IE discharge. Patients who underwent CIED removal during IE admission were compared to those without removal, examining the study outcome of IE readmission within six months after IE discharge. An initial blanking period of 14 days was applied after IE discharge. The Aalen-Johanson estimator and multivariable Cox regression models were used to determine cumulative incidences and adjusted hazard ratios (HRs) of IE readmission according to status of CIED removal, respectively. Results Among 6,843 patients with first-time IE, 5,731 (83.7%) were conservatively treated. Of these, 1,201 (21.0%) had a CIED, of which 205 (17.1%) died during IE admission. Thus, the final study population comprised 996 patients alive at IE discharge. The median age of the study population was 75.5 years (interquartile range [IQR]: 67.9-82.0), and 753 (75.6%) were males. In total, 574 (57.6%) patients underwent CIED removal during IE admission. Patients who underwent CIED removal were younger, compared to patients without CIED removal, 73.1 years (IQR: 65.7-79.1) versus 79.0 years (IQR: 71.3-85.1), respectively. The six-month cumulative incidence of IE readmission was 2.0% (95% confidence interval [CI]: 1.1-3.5%) in patients who underwent CIED removal versus 6.1% (95% CI: 4.0-8.9%) in patients without CIED removal (P-value=0.001) (Figure 1). CIED removal was associated with a significantly lower six-month rate of IE readmission, compared to no CIED removal (HR: 0.36 [95% CI: 0.17-0.77]). Relapse bacteraemia (including IE) with the same microorganism as first-time IE occurred in 2.2% of patients who underwent CIED removal and in 5.4% of patients without CIED removal. Staphylococcus aureus was the most common microorganism in 33.3% of patients with relapse bacteraemia who underwent CIED removal. Conclusions In this nationwide study, the six-month rate of infective endocarditis (IE) readmission was three-fold lower in patients who underwent cardiac implantable electronic device (CIED) removal, compared to patients without CIED removal. The current findings suggest that CIED removal is associated with lower risk of relapse of IE in patients with conservatively treated IE. These results are in line with current guideline recommendations. However, more randomized clinical trial data are needed.

Clinical features of infective endocarditis affecting cardiac implantable electronic devices

Abstract Introduction Infective endocarditis (IE) is a serious condition with high rates of serious complications and mortality. Furthermore, implantation of cardiac electronic devices (peacemakers, ICD, CRT) has been increasing in recent years, with technique-associated infections being one of the main adverse events. Our goal was to analise clinical features of IE as associated with cardiac implantable electronic devices (IE-CIED) and its prognostic impact. Methods Prospective study of a cohort of patients diagnosed with IE in our centre from 1987 to 2022. A comparative analysis was performed between patients with IE not associated with cardiac implantable electronic devices (group 1) and those who did (group 2). Clinical, microbiological, echocardiographic and therapeutic variables were analysed and the prognostic impact was evaluated in terms of mortality. Results 569 patients were analysed, of which 540 (94,9%) belonged to group 1, while 29 (5,1%) belonged to group 2. The mean age was higher in group 2 (65,1 years ±12,9 vs 55,7 years ± 18,7; p=0,011) with male predominance in both populations (67.5% overall). Patients with IE-CIED had a higher proportion of staphylococcus aureus (48.3% vs 19.7%; p<0.001) and staphylococcus epidermidis (34.5% vs 15.6%; p<0.001) infections; nosohusial endocarditis (56.5% vs 20.9%; p<0.001); and underlying heart disease (89.7% vs 67.3%; p=0.012). Furthermore, these patients had a higher proportion of tricuspid valve involvement (18.2% vs 81.8%; p<0.001). Regarding the approach, a higher percentage of surgery was performed in patients with IE-CIED (75.9% vs52.7%; p=0.015). On the other hand, patients with IE not associated to cardiac implantable electronic devices had a higher prevalence of cardiac complications (51.5%vs25.7%;p=0.003), defined as valvular rupture or perforation, pseudoaneurysm, abscess or intracardiac fistula; and central nervous system complications (17.2%vs2.9%;p=0.29). No significative differences were found in terms of echocardiographic findings compatibles with IE, nor were there any differences in severe complications or early, late or total mort ality. Conclusions Infective endocarditis affecting cardiac implantable electronic devices is associated to higher prevalence of staphylococci, underlying heart disease and less involvement of the left heart chambers. Surgery was used to a greater extent in this patients. This entity does not imply a worse prognosis in terms of severe complications or mortality.Table 1.Proportion of IE-CIEDTable 2.Microbiology, mortality

Mortality and patient stratification 30 days after Staphylococcus aureus bacteraemia in patients with cardiac implantable electronic devices - a Danish nationwide cohort study

Abstract Background Staphylococcus aureus bacteraemia (SAB) is a high-risk condition with a reported 30-day mortality of up to 25% even with timely and correct treatment. Patients with cardiac implantable electronic devices (CIEDs) are at increased risk of a complicated course of disease due to the risk of device infection. Purpose We aimed to estimate the 30-day mortality rate following SAB among adult Danish patients with a de novo CIED. Furthermore, we aimed to identify patients with low, intermediate, and high mortality risk following SAB. Methods Using The National Danish Staphylococcus Aureus Bacteriemia Database and The Danish Pacemaker and ICD Register, we identified all Danish patients aged 18 to 99 years with a de novo CIED implantation between 2000 and 2020, and subsequently positive Staphylococcus aureus blood culture. The primary outcome was 30-day all-cause mortality from date of SAB. Clinical variables significantly associated with increased 30-day mortality following SAB were identified (p<0.05 and 95% CI not including 1) using adjusted multivariable Cox regression modelling. We tested variables related to age, sex, calendar year of SAB, device type, timing of infection, previous SAB, concomitant medication, and clinically relevant pre-existing co-morbidities including valvular replacement, recent surgery, and renal dialysis. Patients were awarded 1 point for each of the significant variables present, and the sum was used to stratify into low-, intermediate-, and high-risk groups. The cut-offs between the groups were set at 0 and 2 points (0 points = low risk, 1-2 points = intermediate risk, ≥3 = high risk). Results We identified 1,393 patients with de novo CIED (pacemaker: n=983, implantable cardioverter defibrillator: n=230, cardiac resynchronization therapy w/wo defibrillator capacity: n=180) and subsequent SAB (median time to SAB from CIED implantation: 679 days [IQR 168-1,525]). Median age at the time of SAB diagnosis was 77 years [IQR 68-84] with 72.4% being males. In total, 469 patients died within the first 30 days from SAB, equivalent to an overall 30-day mortality rate of 33.7% (95% CI 31.2-36.2). We identified high age, left sided valvular disease, use of systemic corticosteroids, and SAB occurring >6 months from CIED implantation to be associated with an increased hazard of 30-day mortality following the SAB diagnosis (Fig. 1). The median total sum obtained from the stratification model was 2 points [IQR 1-2]. 30-day all-cause mortality was estimated to 16.2%, 31.6% and 54.9% for the low-, intermediate- and high-risk groups, respectively (Fig. 2). Conclusions In patients with a de novo cardiac implantable electronic device and subsequent Staphylococcus aureus bacteraemia the overall 30-day mortality from date of SAB was 33.7%. Patients with high age, recent surgery, left sided valvular disease, and use of systemic corticosteroids were particularly at risk.Fig. 1.Simplified stratification modelFig. 2.30-day mortality following SAB

Report of cardiac electronic device implant complications over a 7-year study period

Abstract Background The global placement of cardiac implantable electronic devices (CIEDs) is on the rise. Complications linked to device implantation present a substantial burden on healthcare systems and patients alike. It is imperative to comprehend the complication rates associated with CIED procedures, enabling informed decision-making and strategic planning for patients, thereby enhancing the overall quality of care. Purpose We sought to determine post CIED implantation complication rates and provide operator specific complication data for quality assurance at our institution. Methods A comprehensive audit of all procedures completed between April 2016 to March 2023 by 14 high volume operators at a single academic center was completed. Complications and device data were extracted using electronic medical records. Complications evaluated include pneumothorax, infections, hematomas, venous thrombosis, lead perforation, and dislodgement using standardized definitions. Results During the 7-year period, a total of 9,467 procedures were completed. Among the cohort, 62% were male, with an average age of 74.6 ± 15.2 years. The procedural breakdown comprised 60% pacemakers, 19% ICDs, 16% CRTs and 3% ILRs. A total of 11,616 leads were implanted (3,644 RA leads and 1,110 LV leads). The overall complication rate was 3.1% (n=316): device pocket infection 0.68%, superficial infection 0.19%, lead dislodgement 0.53%, lead perforation 0.24%, pericardial effusion 0.1%, pneumothorax 0.15%, pocket hematoma 0.83%, DVT 0.36%, and hemothorax 0.02%. Complication rates per operator are shown in Figure-1. Conclusion Our findings indicate that the overall complication rates for CIED implants are lower than previously reported rates, and there is no significant difference between operators in overall rates of complication. This observation can be attributed to operator experience, advancements in peri-operative care and guideline-directed post-operative protocols. However, notable variations exist among operators in rates of pocket infection. The ongoing monitoring of CIED complications as a quality indicator remains a crucial benchmark, meriting annual assessments for ongoing evaluation.

A sane approach to the high volume of alert transmissions in remote monitoring- turning of clinically non-relevant alerts decreases substantially workload

Abstract Background Remote monitoring (RM) offers a safe and effective method of monitoring patients with cardiac implantable electronic devices (CIEDs). The downside of RM is the data deluge of various transmissions, the majority of which are non-actionable. It has been suggested that optimizing alert transmissions could partly overcome this problem. Purpose The purpose of this study is to evaluate how the workload in RM can be safely decreased by thoroughly assessing the clinical relevance of each alert and deactivating non-relevant alerts. Methods Data on the number of alerts, scheduled and patient-initiated transmissions, as well as the causes and actions initiated by the transmissions, were systematically collected from the year 2023, during which the approach of actively deactivating clinically non-relevant alerts was conducted (A sane approach, Figure 1). The trend of alert transmissions and the proportion of actionable scheduled transmissions are presented. Results Overall, during the study period, 8182 transmissions were generated from 3732 followed CIEDs. Of these, 2306 were alert transmissions, and the rate of alerts decreased by 56% during the follow-up, from 0.07 to 0.04 per device per month. Additionally, our data shows that new alerts that have not occurred in the previous six months occurred on average at a rate of 0.03 per CIED per month, and this trend remained unchanged during the follow-up. Of the 3335 scheduled transmissions, 11% (364) were actionable, and both the number and proportion of actionable scheduled transmissions remained unchanged during the follow-up period. Interestingly, no alerts were triggered from 1124 (70%) of all patients but 88 (2%) of all CIEDs generated 30% of all alerts. Conclusions In this study, we demonstrate that RM workload can be decreased by actively evaluating the clinical relevance of each alert transmission. Our approach, where non-relevant alerts are turned off, likely does not impair patient safety and thus this practise enhance the RM.

Early discharge following cardiac implantable electronic device implantation: a systematic review and meta-analysis

Abstract Background As the demand for cardiac implantable electronic device (CIED) placement rises, healthcare expenses, including the post-procedure hospital stay costs, have been on the increase. This systematic review and meta-analysis were undertaken to evaluate the safety and viability of same-day discharge (SDD) following cardiac device implantations. Methods We conducted a systematic searched of PubMed, Embase and Cochrane database during November 2023 for studies comparing SDD versus discharge after overnight stay (OS) after CIED. Outcomes included all-cause mortality and complications after the procedure (lead/device dislodgment, re-hospitalization, pneumothorax, local hematoma and wound complications). Data from each study were combined using the random-effects model to calculate pooled odds ratio (OR) with 95% confidence interval (CI). Results Eleven studies, including two randomized clinical trials, were incorporated, with a total of 64,646 patients, providing 918 pooled death events (74 in SDD and 844 in OS). The meta-analysis revealed that SDD was associated with a significantly lower risk of all-cause mortality compared to OS (pooled HR 0.72; 95% CI: 0.55-0.93; I2=0%) and no difference was found regarding re-hospitalization (pooled HR 0.96; 95% CI: 0.88-1.05; I2 55%). SSD was not associated with higher lead/device dislodgement (pooled HR 0.93; 95% CI: 0.50-1.71; I2=0%), pneumothorax (pooler HR 1.04; 95% CI: 0.31-3.50; I2 0%) and wound complications (pooled HR 0.65; 95% CI 0.22-1.01; I2 0%). SSD was associated with more episodes of local hematoma (pooled HR 0.31; 95% CI 0.09-1.05; I2 0%). Conclusion Our meta-analysis suggests that SDD is associated with a decreased all-cause mortality compared to OS. Although associated with more episodes of local hematoma, SDD was not significantly different regarding lead/device dislodgment, pneumothorax, re-admissions and wound complications. SDD after CIED appears to be a safe and feasible alternative.

Clinical outcomes of atrial high-rate episodes: an updated meta-analysis

Abstract Background Atrial high-rate episodes (AHRE) are commonly detected in individuals with cardiac implantable electronic devices. Outcomes of atrial high-rate episodes remain unclear in those without a prior history of atrial fibrillation. Purpose This study aims to evaluate clinical outcomes of atrial high-rate episodes in patients who have no prior history of atrial fibrillation. Methods PubMed, EMBASE, and Cochrane databases were searched through February 2024 for studies evaluating clinical outcomes in individuals with cardiac implantable electronic devices who experienced atrial high-rate episodes, compared to those who did not. Individuals who had a prior history of atrial fibrillation were excluded. Outcomes assessed were clinical atrial fibrillation, thromboembolic events, and all-cause mortality. A fixed-effects model was used to calculate risk ratios (RRs) with 95% confidence intervals (CI). A subgroup analysis of thromboembolic events was conducted based on the duration of atrial high-rate episodes. Results A total of 9 studies met inclusion criteria with a combined enrollment of 7440 patients. Compared to those who did not experience atrial high-rate episodes, those who did had significantly increased risks of clinical atrial fibrillation (RR 3.33; 95% CI 1.99 - 5.57; P < 0.0001) and thromboembolic events (RR 2.21; 95% CI 1.72 -2.85; P < 0.0001). The risk of all-cause mortality was similar between both groups (RR 1.19; 95% CI 0.95 – 1.49; P = 0.13). Subgroup analysis revealed an increased risk of thromboembolic events among atrial high-rate episodes ≥ 24 hours (RR 12.34; 95% CI 2.70 – 56.36) while atrial high-rate episodes lasting < 24 hours were insignificantly associated with thromboembolic events (RR 0.83; 95% CI 0.12 – 5.58). Conclusions Our study indicates a heightened risk of clinical atrial fibrillation and thromboembolic events among patients with atrial high-rate episodes, with no observed increase in mortality risk. Furthermore, our findings suggest that the duration of atrial high-rate episodes influences the risk of thromboembolism. Further studies are warranted to confirm our findings.

Remote monitoring of cardiac implantable electronic devices using smart device interface versus radiofrequency-based interface: a systematic review

Abstract Background Guidelines recommended remote monitoring (RM) in managing patients with Cardiac Implantable Electronic Devices (CIED). In recent years, smart device (phone or tablet) monitoring-based RM (SM-RM) was introduced. SM-RM is a specifically developed application (app) which can be downloaded from app stores using smart devices. The app uses Bluetooth low-energy to communicate automatically and securely with the patient’s CIED. The app then uses a cellular or Wi-Fi internet connection to transfer the data securely to the manufacturer’s repository. Purpose This study aims to systematically review SM-RM versus bedside monitor RM (BM-RM) using radiofrequency in terms of compliance, connectivity, and episode transmission time. Methods We conducted a systematic review, searching three international databases from inception until July 2023 for studies comparing SM-RM (intervention group) versus BM-RM (control group). Results Two propensity score-matched studies with a total of 21978 patients were retrieved (9642 patients in the SM-RM arm and 12336 patients in the BM-RM arm) (1, 2). There is significantly higher compliance among patients using SM-RM compared with patients using BM-RM in both pacemaker and defibrillator patients. There were higher enrolment rates and completed scheduled transmissions among SM-RM compared to BM-RM. Higher connectivity was also seen in patients with SM-RM, and more SM-RM patients transmitted at least once compared to BM-RM patients. Additionally, SM-RM patients had more patient-initiated transmissions compared to BM-RM patients. Younger patients (aged <75) had more patient-initiated transmissions, and a higher proportion had ≥10 such transmissions compared with older patients (aged ≥75) in both SM-RM and BM-RM groups. The episode transmission time of SM-RM patients was also shorter than that of BM-RM patients. Conclusion SM-RM is a step in the right direction, with good compliance, connectivity, and shorter episode transmission time. It allows patients to feel empowered and in control of their health. Further research on cost-effectiveness and long-term clinical outcomes can be carried out in the future.

The influence of prolonged antibiotic treatment before lead extraction procedures on the outcomes of device reimplantation in cardiac implantable electronic device infections

Abstract Background Cardiac implantable electronic devices (CIED) related infections have a considerable clinical and economic burden in the cohort of CIED-implanted patients and require a complex and thoughtful approach of the "heart team". Complete CIED removal is recommended for all patients with confirmed CIED infection, but the optimal duration of antibiotic therapy (AT) before lead extraction (LE) and its impact on the time of reimplantation are still debatable [1-2]. This study was aimed to evaluate the impact of prolonged AT before LE on the outcomes of device reimplantation. Methods Consecutive cases of LE due to CIED infection at our centre from 2013 to 2022 were reviewed. Our approach assumed the duration of AT for a minimum of 2 weeks for patients with pocket infection (PI), and at least 4 weeks for endocarditis with the exception of non-response to the AT. The target time for reimplantation was 2-3 days after LE with the exception of uncontrolled infection, positive blood culture, logistical reasons or reevaluation of pacing indications during follow-up. Results From a total of 256 LE, 202 (in 198 patients) were due to CIED infection (pacemaker-67,8%, CRT-19,8%, ICD-12,4%). In 62,4% of the cases there was only PI, in 24,7% only endocarditis and in 12,9% it was concomitant. Systemic infection was found in 43,1% of the cases. The mean dwell time of the leads was 92.2±5.0 months (n=201, median 84, IQR 29.0-132.0). In cases of PI, the mean time of AT before LE was 21,7±1,0 days (n=124, median 21, IQR 14.0-28.0), whereas it was 31,6±1,7 days (n=76, median 28, IQR 21.0-42.0) in cases of endocarditis (p<0.05). The duration of AT after LE was 17.7±0.8 days (n=121, median 14, IQR 14.0-21.0) in cases of PI and 22.7±1.4 days (n=76, median 21, IQR 14.0-28.0) in cases of endocarditis (p<0.05). Procedural success was achieved in 98,5% and the procedural failure rate was 1,5%. Major complication rate was 2,5% and minor complication rate was 8,9%. There was no intraprocedural death. Device reimplantation after LE was performed in 68,8% (139) of all patients. The majority of reimplantations (57,6%) occurred within 7 days after LE (figure 1). The mean reimplantation time was 43.6±12.1 days (n=135, median 6, IQR 4.0-15.0), without statistically significant difference in time to reimplantation between PI and endocarditis (p=0.78). 9 patients were reimplanted with epicardial ventricular lead and 1 with leadless pacemaker. Total reinfection rate was 2% (4), all the cases were due to contralateral PI with reimplantation after LE in 11, 12, 38 and 596 days, respectively. One of the patients was also diagnosed with an allergy to silicone, nickel and palladium. Mortality rate during the first 30 days was 5%. Uneventful 12-month follow-up was achieved by 80,2%. Conclusions Appropriate prolonged AT before LE led to feasibility of early device reimplantation with a low rate of reinfection.Time to preimplantation

Preexisting pulmonary hypertension impact on in-hospital outcomes of cardiac implantable electrical device implantation

Abstract Background Preexisting pulmonary hypertension (PH) is associated with unfavorable in-hospital outcomes in cardiac as well as non-cardiac surgeries and procedures. However, its impact on cardiac implantable electronic device (CIED) implantations is not established. We investigated the extent of preexisting PH among patients undergoing CIED implantations and evaluated its effect on in-hospital outcomes. Methods Using the National Inpatient Sample (NIS) database, we identified patients who were hospitalized in the US between 2016-2019 and underwent CIED implantation with a preexisting diagnosis of PH. Patients with any CIED in-situ were excluded. Sociodemographic, clinical data, in-hospital procedures and outcomes as well as in-hospital mortality were collected. Multivariable logistic regression models were used to identify predictors of in-hospital complications. Results An estimated total of 718,980 patients underwent CIED implantation during the study period. Of them, 74,150 patients (10.3%) had preexisting PH diagnosis. Compared with non-PH patients, PH patients were older, had higher Charlson Comorbidity Index, and more often implanted with implantable cardioverter defibrillators and cardiac resynchronization therapy devices. Higher rate of total complications was observed in PH patients (14.5% versus 9.9%; P<0.001) driven mainly by respiratory complications as well as in-hospital mortality (2.3% versus 1.2%; P<0.001). Multivariable analyses confirmed PH as an independent predictor for respiratory complications, total complications and in-hospital mortality. Conclusion Preexisting PH in patients undergoing CIED implantation was associated with increased risk for respiratory complications as well as in-hospital mortality in a US nationwide, all-comer registry.

Holter monitoring in neuromuscular disorders: frequency and importance in clinical management

Abstract Introduction Cardiac involvement is a common manifestation in a variety of neuromuscular disorders (NMD) and initial cardiac manifestations in these patients are often asymptomatic. Hence, regular 24h-Holter monitoring is recommended to identify conduction disturbances and rhythm disturbances. Purpose In this study, we aimed to assess abnormal findings in 24h-Holter monitoring to screen for conduction disturbances and arrhythmias in patients with NMD and evaluate its impact in patients’ treatment. Methods A retrospective single-centre study was conducted including all adult patients with NMD who received a 24h-Holter from January 2013 to September 2023. Results A total of 76 patients with NMD were included, 39 (51.3%) were male, and mean age was 46,3 ± 11,5 years. Most patients were asymptomatic. A total of 220 Holter recording was analysed. An average of 2,9 ± 1,6 Holter recordings per patient was performed. Abnormal Holter results were found in 47 (61,8%) patients, and mainly consisted of conduction disorders such as atrioventricular block in 31 (65,9%) patients. Other abnormalities included atrial fibrillation/flutter in 6 (12,8%) patients, supraventricular tachycardia in 4 (8,5%) patients, and non-sustained ventricular tachycardia in 6 (12,8) patients. Out of the group of the patients with abnormal Holter findings, ten patients had direct clinical treatment consequences, namely implantation of cardiac electronic devices or initiation of anticoagulation therapy. Conclusion In this study, holter findings resulted in relevant clinical treatment consequences in 10 out of 76 patients (13,2%). These results suggest that 24h-Holter monitoring may improve routine cardiac screening in patients with NMD.

Cost impact of the use of a universal cardiac implantable electronic devices remote monitoring solution: results of the Evidence RM study

Abstract Background Remote monitoring (RM) is considered the standard of care for patients with cardiac implantable electronic devices (CIED). In 2023 the HRS/EHRA/APHPRS/LAHRS expert consensus highlighted the potential interest of alert-based monitoring and the use of a third-party platform for RM management. By lightening the RM workload for clinical staff, valuable time and resources can be redirected towards patient care. Purpose This study aims to assess the impact on healthcare expenditures of the adoption of a Universal, vendor-neutral, and alert-focused remote monitoring (RM) platform for CIED in France, as opposed to the Conventional RM conducted via device specific manufacturers' platforms. Methods This study utilizes the French National Health Database (SNDS) to evaluate the effectiveness of RM solutions among patients with implantable cardioverter defibrillators (ICD), including cardiac resynchronization therapy defibrillators (CRT-D). All patients under RM were categorized based on the type of monitoring, either the Universal RM or the Conventional RM. The analysis was conducted on year 2019 and included only patients maintaining consistent RM solutions and device types throughout the entirety of the study period. To mitigate potential biases, costs were adjusted according to age, gender, device type, year of first implantation, year of RM initiation, medical center experience with RM, and Elixhauser score for comorbidities. Results Study cohort consisted of 36,401 patients (age 67.3 ± 13.0 years / male 78.4% / CRT-D 40.1%), 1,482 patients followed using the Universal RM platform and 34,419 patients monitored with the Conventional RM solutions. The study findings revealed a 4% decrease in corrected total costs and a notable 17.8% reduction in hospital costs among patients utilizing the Universal RM. Analysis further identified that this decrease in hospital expenses was primarily influenced by a reduction of the costs associated with cardiovascular diseases. Conversely, the group utilizing the Universal RM experienced a 7.9% increase in total outpatient costs compared to Conventional RM, while ambulatory visit costs remained unchanged. As costs incurred by patients were not included, total costs may however be underestimated. Patients under the Universal RM solution may benefit of more proactive preventive measures delivered through outpatient care. By addressing issues preemptively, critical conditions may be averted, enhancing overall patient management, and diminishing hospital costs. The adoption of a third-party Universal platform may thus yield to cost savings, exemplified by a negative Incremental Cost-Effectiveness Ratio (ICER) of -103€ per Day Alive and Out of Hospital (DAOH) as observed in this study. Conclusions The use of a third-party Universal RM platform showed a positive impact in terms of costs reduction for the French healthcare system on this ICD population.

Ventricular and supraventricular ectopic beats burden is correlated with bone mineral density and osteoporotic fracture risk in postmenopausal females

Abstract Introduction Patients (pts) with osteoporosis (OP) have an increased 10-year cardiovascular death risk. Low bone mineral density (BMD) observed in OP may be associated with arrhythmic presentation of cardiovascular diseases (CVD). Few studies assessed the relationship between OP and arrhythmia. Aim Arrhythmias assessment in pts with OP. Methods A total of 103 postmenopausal female pts (mean age 69 +/- 7), consulted by endocrinologist, were divided into 2 groups according to BMD (assessed by dual energy X-ray absorptiometry). BMD measurements, expressed as T-score (T-sc), were taken from the femoral neck (T-sc Neck), entire total hip (T-sc TH) and/or spine (T-sc L2-L4, L1-L4). Arrhythmia was evaluated using 24-hour Holter-ECG monitoring (HM). Major osteoporotic and total hip fracture risks (MOFR and THFR, respectively) were assessed by the FRAX scale. We compared 51 pts with OP (T-sc ≤ -2.5), with 52 matched controls without OP, including 44 pts with osteopenia (T-sc > -2.5). There were no significant differences between the groups regarding the history of stroke, myocardial infarction, coronary artery disease or arterial hypertension. Exclusion criteria included heart failure NYHA >II and/or LVEF <36%, acute coronary syndrome within the last 6 months, severe valvular disease, cardiac implantable electronic device. Results There was a trend towards a greater number of supraventricular and ventricular arrhythmias in the OP group compared to the controls. Arrhythmic burden was significantly correlated with BMD measures: correlations were observed between 24-hour ventricular ectopic beats (VEB) count with T-sc Neck (r=-0.20, p=0.04), with T-sc TH (r=-0.22, p=0.03). The number of supraventricular ectopic beats (SVEB) in HM was also correlated with BMD parameters: T-sc Neck (r=-0.21, p=0.03), T-sc TH (r=-0.23, p=0.02). Multivariate analysis (linear regression model) revealed that age and T-sc TH were independently related with ectopy: age (0.07; CI: 0.01 - 0.13, p=0.03) and T-sc TH (-0.58; CI: -1.07 - -0.08, p=0.02) were predictors for VEB, and SVEB were related to age (0.07; CI: 0.03 - 0.12, p<0.01) and, with borderline significance with T-sc TH (-0.34; CI: -0.699 - 0.012, p=0.058). Ectopic beats count was also positively correlated with osteoporotic fracture risk: VEB with THFR (r=0.206, p=0.04) and SVEB with MOFR (r=0.21, p=0.04). Conclusions The study showed an increased arrhythmia burden as detected in HM in pts with OP. Beside the T-sc TH, age was identified as an independent factor of increased SVEB / VEB. The main significant negative correlations were observed between the number of VEB / SVEB and BMD in femur (T-sc Neck, T-sc TH). Ectopic beats count was also positively correlated with osteoporotic fracture risk: VEB with THFR and SVEB with MOFR.

Remote management of worsening heart failure events and subsequent rate of emergency department admission

Abstract Background Worsening heart failure (WHF) is the leading cause of hospitalization among individuals aged ≥ 65 years and constitutes a substantial burden for both the patient and the healthcare systems. Moreover, heart failure contributes to exacerbate the pressure on emergency departments which are involved in 64% of heart failure hospital admission (1). Remote management of heart failure as been shown to reduce the number of days lost due to unplanned cardiovascular hospitalizations and all-cause mortality (2, 3), but little is known about the effect on the emergency healthcare use. We aimed to describe the effect of a telemonitoring program on the rate of emergency admissions for WHF in chronic heart failure patients. Methods All patients enrolled in the heart failure remote management program of two French centers between 13 April 2020 and 31 January 2023 were included in the study. Follow-up data were collected until 31 January 2023. Inclusion criteria were chronic heart failure (HF) with New York Heart Association ≥II and an elevated B-type natriuretic peptide (BNP > 100 pg/mL or N-terminal-pro-BNP > 1000 pg/mL). Remote evaluation included measurements of body weight, blood pressure, heart rate, symptoms, biochemical parameters, and data from cardiac implantable electronic devices when available. Results A total of 1,095 patients (72±11.8 years old, 69.7% male), were followed for a median [IQR] of 437 [182; 739] days with a mean adherence to the remote monitoring system of 67.6±30.3%. Over this period, 198 (18.1%) patients had 949 WHF events, the majority of whom were remotely detected: 830 (87.5%). Overall, 246 (26%) of the WHF episodes required hospitalisation and 109 (11%) prompted an emergency department visit. When the WHF event was remotely detected, hospitalization was only required in 127 (15%) cases and the rate of emergency department visit was reduced to 3%. Conclusion In HF patients engaged in a multiparametric remote management program, the rate of emergency department admission is very low. Adopting such a strategy for patients with chronic HF may be useful in reducing emergency department overcrowding.Baseline characteristics of patientsPatients course and use of resources

Assessment of right ventricular function in patients with severe secondary tricuspid regurgitation, following to the TVARC recommendations: association with outcome

Abstract Introduction Severe tricuspid regurgitation (TR) is associated with increased mortality if left untreated. Recently, the Tricuspid Valve Academic Research Consortium (TVARC) has published standardized definitions of disease aetiology and severity, as well as endpoints for future clinical trials. Right ventricular (RV) function assessment represents one of the cornerstones for risk stratification in these patients, but current guidelines do not propose specific cut-off values for the echocardiographic measures. Also, the thresholds proposed by the TVARC have been derived from normative value and not yet validated in large cohorts of TR patients. Purpose To test the prognostic value of the TVARC proposed echocardiographic cut-offs for grading RV-dysfunction (figure1) in a large real-world cohort of patients with severe secondary TR (STR). Methods Consecutive patients from a single centre with first diagnosis of severe secondary STR, and without a cardiac implantable electronic device, were included. Tricuspid annulus plane systolic excursion (TAPSE), RV global and free wall strain (RVGLS and RVFWLS) and fractional area change (FAC) were used to measure RV function. The study endpoint was all-cause mortality, censored for tricuspid valve intervention. Results A total of 1043 patients (mean age 69 ± 13 years, 43% male), were included. Approximately half of the population (45%) was in NYHA class III or IV and 52% was treated with loop diuretics. Overall patients showed mild RV-dilatation (RV end-diastolic area indexed 12.2 [10.1-15.2cm2/m2]) and moderate-to-severe right atrial dilatation (right atrial maximal area indexed: 13.9 [11.0-17.5cm2/m2]). Using the proposed cut-off values, strain analysis identified a higher number of patients with impaired RV function as compared to standard echocardiographic parameters (89% based on RVGLS; 80% based on RVFWS, 61% based on TAPSE and 54% based on RVFAC). During a median follow-up of 51 [IQR 6 - 98] months, 445 (43%) patients died. The Kaplan-Meier survival curves for each echocardiographic parameter of RV-function are shown in Figure 1. TAPSE, which is the most widely used RV-function parameter, was able to clearly identify patients at high and intermediate risk when mildly, moderately and severely impaired. However, patients with normal TAPSE were still at intermediate risk when RVFWLS was (even mildly) reduced (figure 2). We therefore propose a stepwise practical approach including the measure of RVFWLS when measuring normal TAPSE, in order to possibly re-stratify patients into a higher risk group (Figure 2). This novel grading approach remained independently associated with all-cause mortality after correcting for relevant clinical and echocardiographic variables on multivariable analysis. Conclusion Novel TAVRC cut-off values for RV function show prognostic value in patients with severe STR; particularly the combination of TAPSE and RVFWLS could be use in clinical practice for risk stratification.Figure 1Figure 2

Prognostic implication of right ventricular - pulmonary arterial coupling in patients with non-valvular atrial fibrillation

Abstract Background The clinical importance of right ventricular (RV) - pulmonary arterial (PA) coupling has been reported in various cardiac diseases such as right heart failure, pulmonary hypertension, and valvular dysfunction. However, there is limited data on patients with non-valvular atrial fibrillation (AF). We aim to investigate whether RV-PA uncoupling affects the clinical outcome in patients with non-valvular AF. Methods A total of 807 consecutive patients with non-valvular AF who underwent echocardiography (mean age 70 ± 12 years, 39% female) were included. We excluded patients with significant (at least moderate degree) valvular diseases, left ventricular ejection fraction (LVEF) <50%, cardiac implantable electronic devices, previous cardiac surgery, and poor echocardiographic image for RV analysis. RV-PA coupling was assessed by the ratio of RV global longitudinal strain (GLS) to PA systolic pressure (PASP), and decreased RV-PA coupling was defined as less than 0.52 %/mmHg based on on the receiver operating characteristic analysis. The primary outcome was the composite of all-cause death and hospitalization for heart failure. Results Over a mean of 4.7 ± 3.5 years of follow-up, 178 (22%) patients had experienced primary outcomes. Among them, 107 (13%) patients were hospitalized for HF and 90 (11%) patients died. Patients with decreased RV-PA coupling were older (73 ± 11 vs. 68 ± 12 years, p<0.001), had a higher prevalence of females (51 vs. 33%, p<0.001) and diabetes (33 vs. 23%, p=0.003), lower left ventricular ejection fraction (60 ± 5 vs. 61 ± 5%, p=0.011), higher E/e’ (14 ± 5 vs. 11 ± 4, p<0.001), larger left atrial volume index (78 ± 37 vs. 62 ± 22 ml/m2, p<0.001) and larger RV end-systolic area (11 ± 4 vs. 10 ± 3 cm2/m2, p=0.001) compared to those with preserved RV-PA coupling. In multivariate Cox regression analysis, decreased RV-PA coupling was associated with worse clinical outcomes even after adjusting for age, diabetes, E/e’, and RV end-systolic area (Hazard ratio [HR] 1.50, 95% Confidence interval [CI] 1.09 – 2.07, p=0.014) (Figure 1). Conclusions In patients with non-valvular AF, RV-PA coupling was associated with clinical outcome, suggesting that it may provide additional information for predicting future cardiovascular risk in this population.

Complications after cardiac implantable electronic devices in patients with severe mental illness: a Danish nationwide study

Abstract Background Patients with mental illness experience higher rates of postoperative complications and mortality across several types of surgery, but knowledge is lacking in relation to cardiac implantable electronic device (CIED) implantations. Purpose Our study aimed to investigate the 7-day, 30-day, and 90-day postoperative complication rate and mortality in patients with severe mental illness compared to the general population. Methods All adult patients in Denmark with a first-time pacemaker or ICD implantation during the study period from July 1995 to December 2022 were identified using the Danish nationwide registers. Severe mental illness was defined as having a preexisting diagnosis of schizophrenia and other non-affective psychotic disorders, bipolar affective disorders or major depressive disorder. Postoperative complications were obtained as diagnosis codes possibly relating to device implantation and categorized into seven types of complications: arterial thrombosis, venous thrombosis, pneumothorax, bleeding, infection, device function problem, and death. Stratified logistic regression analyses adjusted for sex and age were used to calculate the odds of postoperative complications within 7, 30, and 90 days of device implantation. Results Among 108,790 patients who had a de novo pacemaker or ICD implantation the mean age was 73.5 (± 12.8), 37.5% were women and 3,393 (3.1%) of the patients had preexisting severe mental illness. In total, 10,690 (9.8%) patients had one or more complications within 90 days. The number of patients with severe mental illness who experienced a complication were 407 (12.0%) while it was 10,283 (9.8%) of those without severe mental illness. Odds of death (OR 1.57, 95% CI: 1.03-2.29) were higher in patients with severe mental illness 7 days postoperatively, and 30 days postoperatively odds of venous thromboembolism (OR: 1.69, 95% CI: 1.05-2.56) and death (OR: 1.62, 95% CI: 1.29-2.01) were higher in patients with severe mental illness. 90 days postoperatively odds of venous thrombosis (OR: 1.95, 95% CI: 1.37-2.70), infection (OR: 1.45, 95% CI: 1.16-1.79), and death (OR: 1.40, 95% CI: 1.19-1.65) were higher in patients with severe mental illness compared to patients without severe mental illness, while the odds of pneumothorax were lower at all three time points for patients with severe mental illness (OR 7-days: 0.49, 95% CI: 0.21-0.95). The odds of arterial thrombosis, bleeding and device function problems were similar between the two groups at all three time points. Conclusion Severe mental illness was associated with increased risk of several types of complications and death following CIED implantation. This indicates that further care and attention is needed to ensure adequate treatment of patients with severe mental illness suffering from cardiac arrhythmias.Forest plot, SMI: severe mental illness