Cardiac Implantable Devices Research Articles

Magnetic Resonance Myocardial Imaging in Patients With Implantable Cardiac Devices: Challenges, Techniques, and Clinical Applications.

Cardiovascular magnetic resonance imaging (MRI) in patients with cardiac implants, such as pacemakers and defibrillators, has gained importance in recent years with the development of modern cardiac implantable electronic devices. The increasing clinical need to perform MRI examinations in patients with cardiac implants has driven the development of new advanced MRI sequences to mitigate image artifacts associated with cardiac implants. More specifically, advances in imaging techniques, such as wideband late gadolinium enhancement imaging, wideband T1 mapping, and wideband perfusion, have been designed to improve image quality and examinations in patients with cardiac implants, enabling a comprehensive and more reliable diagnosis, which was previously unattainable in these patients. This review article explores recent developments and applications of wideband techniques in the field of cardiovascular MRI, offering insights into their transformative potential. Clinical applications of wideband cardiovascular MRI are highlighted, particularly in assessing myocardial viability, guiding ventricular tachycardia ablation, and characterizing myocardial tissue.

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.

Incidence of silent brain injury in pacemaker implanted patients with atrial high-speed episodes (AHRE)

Abstract Purpose Atrial high rate episodes (AHRE) are tachyarrhythmia attacks that can be detected by implantable cardiac devices. In the European Society of Cardiology (ESC) 2020 AF guideline, AHRE is defined as ≥ 175 bpm for the device-programmed rate criterion and ≥ 5 minutes for the duration criterion. AHRE has been shown to be one of the predisposing factors of AF and stroke. However, the relationship between AHRE and SBI has not been clarified yet. Neuron spesific enolase (NSE) is a valid biomarker for quantifying the volume of neuronal damage. In this study, we aimed to evaluate the incidence of silent brain injury (SBI), defined as elevated NSE levels in AHRE detected patients. Method Between January 2021 and June 2022, 80 patients who underwent routine pacemaker control, met the inclusion and exclusion criteria, and had AHRE detected in their permanent pacemaker records were included in a university faculty of medicine cardiology arrhythmia polyclinic. For the control group, patients who had a permanent pacemaker and did not have AHRE or any other arrhythmia were included. Of patients with AHRE detected in the last 6 months and those who had an AHRE attack within the last 72 hours were examined. Results Individuals included in the study were divided into subgroups according to AHRE duration. Group 1 (non-AHRE) 80 (50.0%), Group 2 (AHRE lasting <5 min) 24 (15.0%), Group 3 (≥5 min - <1h) 33 (20.6%), 19 (11.9%) patients in Group 4 (lasting ≥1 h - <24 h) and 4 (2.5%) patients in Group 5 (lasting ≥24 h). There was a statistically significant difference in NSE median values between groups (p=<0.001). In Mann Whitney U test with Bonferronni correction, the median values of all other groups were significantly different from each other (p=<0.001). In the correlational analysis, there was a statistically significant positive relationship between AHRE duration and NSE values (r=0.842; p=<0.001). Additionally, there was correlation between AHRE duration and age (r=0.235; p=0.036), CHA2DS2-VASc score (r=0.226, p=0.044) and LA diameter (r=0.300; p=0.007). NSE levels were positively correlated with AHRE duration (r=0.842; p=<0.001) and LA diameter (r=0.242; p=0.030). Conclusion AHRE duration was longer in patients with advanced age, increased CHA2DS2-VASc score, and increased LA diameter. This may play a role in explaining the underlying pathophysiological changes in AHRE before AF develops. Since NSE levels are related to LA diameter as well as AHRE duration, it can be thought that increasing LA diameter contributes to the development of thrombus.

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

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.

Impact of SLGT2 inhibitors treatment initiation on the reduction of atrial and ventricular arrhythmias in patients with implanted cardiac defibrillator

Abstract Introduction Sodium-glucose cotransporter type 2 inhibitors (SGLT2i) have been associated with improved prognosis in patients with heart failure; however, their impact on atrial arrhythmic (AA) and ventricular arrhythmic (VA) events is not fully understood. Methods Retrospective multicentric study of heart failure patients with implantable cardiac defibrillator device (ICD) from 2015 to 2020 with or without cardiac resynchronization therapy (CRT) receiving SGLT2 inhibitors. Device-registered arrhythmic events were analyzed and compared in two time periods for each patient: one year before and one year after starting SGLT2i. Relevant VA were defined as the occurrence of any sustained VT (SVT) (>30 seconds), ventricular fibrillation (VF), or appropriate therapy (antitachycardia pacing or shock). All VA included all the relevant VA and the occurrence of non-sustained ventricular tachycardia (NSVT). AA included atrial fibrillation (AF) burden, and episodes of more than 24 hour of AF. Results A total of 195 patients (66.8 [61.3-73.1] years, 18.5% women) were included. A reduction was observed in the percentage of patients with any VA (pre: 52.3% vs post: 30.3%; P < 0.001) and clinically relevant VA (excluding NSVT) (pre: 21.5% vs post 8.7%; P < 0.001) in the post-SGLT2i period. There was also a reduction in the number of episodes per patient/year of NSVT (pre: 2 (1-5) vs post: 1 (0-2); P < .001), and SVT (pre: 1 (1-3) vs post: 0 (0-2); p = 0.046). This protective effect was also observed after controlling confusion factors (Any VA: OR 0.35 (0,24-0,50); p<0.001 and relevant VA: OR 0.30 (0,17-0,52); p<0.001). However, no differences were observed in the prevalence of AA (24.7% vs 18.8%; P = 0.117) or the burden of atrial fibrillation (pre: 0% (0-0.1) vs post 0% (0-0); p = 0.097). Conclusions Following the initiation of SGLT2i treatment, a reduction in the percentage of patients with relevant VA was observed. However, this effect was not observed for AA.Figure 1Figure 2

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.

A prospective study of a novel pocket compression device to reduce pocket hematoma after cardiac implantable electronic device implantation in a high bleeding risk population

Abstract Background Pocket hematoma (PH) is one of the most common complications after cardiovascular implantable electronic device (CIED) implantation resulting in an up to 9 times higher risk for CIED infections.(1) Different preventive strategies have been proposed with mixed results. Current standard of care consists of preventive elastic adhesive tape leaving 2 major disadvantages: unpredictable pressure on the pocket and inability to visually assess the pocket with the bandage applied. Aim To evaluate the safety and effectiveness of a novel pocket compression device in patients undergoing CIED implantation in a high bleeding population. Material and methods This randomized controlled trial included 32 patients in the study group (pocket compression device) and 33 in the control group (elastic adhesive tape). The studied pocket compression device contains an inflatable compartment to modify the degree of pocket compression which is transparent facilitating pocket evaluation. The primary outcome was the incidence of various grades of PH. The secondary outcomes comprised the incidence of pressure lesion, pain score (0-10) and endocarditis during follow-up. Results There were no clinical or procedural differences between groups (age 78.01±9.71, heart failure 53.8%, kidney failure 20.0% and on antithrombotic drugs 49.2%). There were significantly less pocket hematomas in the study group (1/32 (3.1%) vs 20/33 (60.6%), P<0.001). Most pocket hematomas were grade I for which watchful waiting was applied (1/32 (3.1%) vs 17/33 (51.6%), P<0.001). Grade II and grade III PH only occurred in the control group (respectively 1/33 and 2/33) resulting in hospitalization prolongation and longer interruption of antithrombotic drugs >24hours. Two control patients eventually received the study device to control PH. None underwent reoperation. Pressure lesions did not occur. Patients in the study group had lower pain scores at application (0.75±1.12 vs 1.80±1.38, P=0.009), after 2 hours (0.81±1.36 vs 1.94±1.50, P=0.002) and the next day (0.38±0.91 vs 1.06±1.634, P=0.042). None of the patients experienced endocarditis during mean follow-up of 1 year. Conclusion The use of a pocket compression device in patients undergoing CIED implantation in a high bleeding population leads to less PH and postoperative pain in comparison to conventional elastic adhesive tape.bandage study

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

Routine chest X-ray post cardiac implantable electronic device implantation: is it really required? Experience from a tertiary centre

Abstract Introduction The 2021 EHRA expert consensus statement on pacemaker (PPM) and transvenous implantable cardioverter defibrillator (ICD) implant technique proposes a chest X-ray (CXR) prior to hospital discharge in all patients. This recommendation serves the dual purpose of excluding pneumothorax following subclavian or axillary access (SAA) and documenting lead position. Purpose Given that cephalic venous access (CA) precludes pneumothorax, the utility of CXR as a tool for identifying early lead displacement (LD) in these patients warrants further examination. We studied the yield of post implant CXR, device interrogation (DI), or both for the identification of pneumothorax and LD in patients undergoing transvenous PPM or ICD implant via SAA or CA. Methods 4,051 consecutive PPM or ICD devices were implanted at a tertiary centre between 2016-2019. Lead position was documented fluoroscopically on conclusion of all procedures. A subsequent post implant CXR was performed in cases of SAA, plus in those CA patients requiring imaging for another indication (e.g. pulmonary oedema). Post implant DI was only performed in patients with a high anticipated burden of ventricular pacing (e.g. high-grade atrioventricular block). All patients underwent clinical review with repeat DI at 30 days post implant. LD was defined as a clinically significant translocation of a lead requiring repositioning or reprogramming. Results For the whole cohort, the incidence of LD at 30 days was 2.2% (n=89), and the incidence of pneumothorax (within the SAA group) was 0.9% (n=11). The venous access method used, post implant investigations, and the incidence of LD is shown in Figure 1. 1,282 patients (31.6%) required SAA; CXR was performed in all, and 9 LDs were identified (0.7%). However, four patients (0.3%) with ‘normal’ CXRs had evidence of LD on inpatient DI, and a further 17 LDs (1.3%) were confirmed on the 30 day DI despite a ‘normal’ CXR. 2,769 patients (68.4%) underwent CA; 309 (11%) required CXR. This identified LD in four patients (1.3%), with three further patients (1%) found to have LD on subsequent inpatient DI despite a ‘normal’ CXR. A further four LDs (1.3%) were diagnosed at 30 day DI. The majority (89%, n=2,460) of CA patients were discharged without CXR. 30% (n=825) of these patients required inpatient DI; this identified 13 LDs (1.6%). Accordingly, 59% (n=1,635) of CA patients had no post procedural investigations; 24 (1.5%) were found to have LD at 30 day DI. Conclusions In patients who developed LD within 30 days of a PPM or ICD implant, a post implant CXR identified this in only 32% of cases (n=13/41), and the overall sensitivity of CXR for LD was low (50%). Additionally, the majority of LDs (54%) occurred after hospital discharge. We suggest that the utility of post implant CXR for identifying LD is limited, and that CXR should not be considered an essential investigation in CA device implants.Figure 1

Ultrasound-guided versus fluoroscopy-guided axillary vein puncture for cardiac implantable electronic device implantation: a meta-analysis enrolling 1257 patients.

Ultrasound-guided (Echo-AVP) and Fluoroscopy-guided Axillary Vein Puncture (Fluoro-AVP) are both acknowledged as safe and effective techniques for transvenous implantation of leads for cardiac implantable electronic devices (CIEDs). Nonetheless, it is still debated which of the two techniques has a better safety and efficacy profile. Therefore, we performed a meta-analysis to evaluate the efficacy and safety of Echo-AVP versus Fluoro-AVP for CIEDs implantation. We systematically searched Medline, Embase and Cochrane electronic databases up to May 15th, 2024, for studies that evaluated the efficacy and safety of Echo-AVP and Fluoro-AVP reporting at least one clinical outcome of interest. The primary efficacy endpoint was acute procedural success and the primary safety endpoint was a composite endpoint of pneumothorax, pocket hematoma/bleeding, pocket infection and inadvertent arterial puncture. The effect size was estimated using a random-effect model as Odds Ratio (OR) and Mean Difference (MD) with relative 95% Confidence Interval (CI). Overall, 4 studies were included, which enrolled 1257 patients (Echo-AVP: 373 patients; Fluoro-AVP: 884 patients). Echo-AVP led to a significant reduction in the primary safety endpoint (OR: 0.41; p = 0.0009), risk of inadvertent arterial puncture (OR: 0.29; p = 0.003) and fluoroscopy time ( MD: -105.02; p = 0.008). No differences were found between Echo-AVP and Fluoro-AVP for acute procedural success (OR: 0.77; p = 0.27), pneumothorax (OR: 0.66; p = 0.60), pocket hematoma/bleeding (OR: 0.68; p = 0.30), pocket infection (OR: 0.66; p = 0.60), procedural time (MD: 1.99; p = 0.65), success rate at first attempt (OR: 1.25; p = 0.34) and venous access time (MD: -0. 25; p = 0.99). Echo-AVP proved to reduce significantly the primary safety endpoint, inadvertent arterial puncture and fluoroscopy time compared to Fluoro-AVP.

Real-Time Ambulatory ECG Does Not Expedite Care.

Ambulatory ECG (AECG) monitoring is pivotal to the diagnosis of arrhythmias and can be performed with near "real-time" notification of abnormalities. There are limited data on the relative benefit of real-time monitoring compared with traditional Holter monitoring. This is a retrospective observational analysis of University of Utah Health patients who underwent ambulatory ECG studies from 2010 to 2022. The study cohort was stratified by patients with an ambulatory ECG that provides real-time event notification (non-Holter) versus those who do not (Holter). The outcomes were cardiac implantable electronic device procedure, ablation procedure, emergency department/hospitalization visit, and initiation of anticoagulation out to 6 months. We identified 20 259 patients, 16 650 with non-Holter studies and 3609 with Holter studies. Holter patients were younger (mean 52 versus 55, P<0.001), more often women (60.2% versus 57%, P<0.001), and had lower mean CHADS2-VA2Sc scores (1.7 versus 2.1, P<0.001). The median time to ablation procedure was 74 versus 72 (P=0.5), for Holter versus non-Holter, respectively. Median days to new cardiac implantable electronic device implantation was 54 days versus 52 (P=0.6); initiation of anticoagulation among patients not already treated was 42 versus 31 days (P=0.03). Time to first emergency department visit or hospitalization was 63 versus 57 (P=0.6). In multivariable models, there were no significant differences in time to intervention between Holter and non-Holter for each outcome. Real-time monitoring demonstrates mixed results in terms of reducing time to intervention, with the significant benefit limited to oral anticoagulation initiation. It is time to revisit clinical scenarios where real-time ambulatory monitoring may not improve health care efficiency.

Magnetic Resonance-Guided StereotacticRadioablation for SeptalVentricular Tachycardias.

Stereotactic arrhythmia radioablation (STAR) was introduced to treat ventricular tachycardia (VT) refractory to catheter ablation. No data are now available in the septal VT substrate setting, representing a challenge when using conventional techniques. This study sought to evaluate the arrhythmic burden in patients with septal VT treated with magnetic resonance-guided STAR (MRgSTAR). We enrolled consecutive patients with septal VT substrate. The therapy target was achieved by combining anatomic/functional and electrophysiologic information. Patients were treated with a single fraction of 25Gy adopting MRgSTAR. All patients were clinically followed up, and all implantable cardiac devices were remotely monitored. The efficacy outcome included recurrences of any sustained VT beyond the 6-week blanking period after MRgSTAR. The safety outcome was the incidence of adverse events and atrioventricular block. We included 11 patients with septal substrate VT (median age: 68 years; Q1-Q3: 64.5-78 years; 100% male). Clinical presentation was an electrical storm in 81.8% of patients. No complications occurred after MRgSTAR, and 6(54.5%) patients were discharged on the same day of treatment. During a mean follow-up of 12 ± 6months, the efficacy outcome occurred in 3 (27.3%) cases. A significative reduction of implantable cardioverter-defibrillator (ICD) therapy (23.6 before MRgSTAR vs 1.7 after MRgSTAR; P< 0.001) was observed. Left ventricular ejection fraction increased significantly after treatment (38% [Q1-Q3: 33.5%-42.0%] before MRgSTAR vs 43.8% [Q1-Q3: 35%-47%] after MRgSTAR; P=0.04). No adverse effects were observed in the implantable cardioverter-defibrillator and lead system; in the 7 patients with preserved atrioventricular conduction, no atrioventricular block was reported. MRgSTAR represents a safe and effective strategy for treating septal VT.

Características de la insuficiencia tricúspide grave inducida por dispositivos de estimulación intracardiacos

Introduction and aimsTricuspid regurgitation (TR) induced by the implantation of cardiac implantable electronic devices (CIED) is an increasingly common cause of severe TR. Our aim was to describe the echocardiographic phenotypic characteristics of CIED-induced severe TR. MethodsRetrospective cohort study that included patients with severe TR related to CIED diagnosed in the cardiac imaging unit of a Spanish tertiary hospital. Results37 patients with severe TR induced by lead/electrode interference formed our study group. TR was predominantly severe (68%), followed by massive (21%) and torrential (11%). The leaflet most affected by the interference was the septal. 58% of the sample presented severe dilatation of the right atrium (RA) (mean RA area 28cm2). Mean tricuspid annulus measurement was 42mm. The usual parameters for quantifying RV systolic function were on average within the normal range (TAPSE mean 19mm, S’ wave 10mm, FAC 41%), while global RV strain (RVGLS -15%) and free wall strain (RVFWLS -19%) were found reduced. An incipient degree of ventricular/pulmonary arterial uncoupling was evident (mean TAPSE/PSAP 0.34, SGLVD/PSAP 0.27%/mmHg). ConclusionsOur patients with CIED-induced severe TR are characterized by a heterogeneous phenotype with a high prevalence of severe RA and tricuspid annulus dilatation. RVGLS, RVFWLS, and arterial ventricular coupling were the most sensitive parameters for early assessment of RV systolic dysfunction.

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

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

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

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

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

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

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

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

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

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

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

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