Cardiac Implantable Devices Research Articles

Abstract 4145819: Reducing the Burden of the Opioid Epidemic by Adopting a Novel Pain Control Strategy Utilizing Pectoral Nerve Block in Adults Undergoing Transvenous Cardiac Device Implants

Introduction: Despite early mitigation efforts, the opioid pandemic in the United States has persisted and affected many Americans. A public health emergency was declared urging all prescribers to use caution in prescribing opioids. Alternative approaches to postoperative pain management during transvenous cardiac device implants (TCDI) in adults have not been described. Methods: We report a single-center retrospective analysis of 612 consecutive patients that underwent TCDI between January 2021 and January 2024 with ultrasound guided pectoral nerve block (PNB) using liposomal bupivacaine prior to implant for postoperative pain management. Pain scores (0-10) were recorded systematically in the postoperative period, at discharge, and at wound check follow-up. Any need for opioid use in the postoperative period was recorded as well. Results: A total of 612 patients were evaluated, 50% female with a mean age of 71.2 years. All patients received PNB successfully with no device site infection or hematomas. The mean Visualized Analog Scale (VAS) pain scores at 1, 3, and 5 hours after the procedure, at discharge, and at the follow-up visit were 1.93, 1.22, 1.10, 1.05, and 0.13 respectively. During follow-up, no patients required opioids for pain control throughout the entire postoperative period of 14 days. Conclusion: Pectoral nerve block with liposomal bupivacaine can be performed safely preoperatively during TCDI and provides adequate pain control without need for opioid use postoperatively. Further research is needed to assess broad scale implications of this approach to larger patient populations.

Management of iatrogenic atrial perforation caused by pacemaker electrodes: a case report

BackgroundThe complications associated with cardiac device implants ranges between 5.3% and 14.3%. Cardiac perforation due to “leads” represent a very rare complication of cardiac device implantation, ranging between 0.3% and 0.7%. Clinically, they can manifest different, nonspecific symptoms; hence, the diagnosis may not be immediate.Case presentationOur clinical case describes the successful treatment of cardiac tamponade occurring in a Caucasian 79-year-old man following a pacemaker implantation. Two days after the procedure, the patient reported an episode of nonspecific chest pain associated with syncope. The echocardiogram performed revealed a pericardial effusion in the apical area, along the right chambers, with a thickness of 7 mm, not hemodynamically significant. A chest computed tomography scan with contrast showed hemopericardium (maximum thickness of 11 mm), caused by an atrial perforation. A few hours later, the patient experienced hemodynamic instability. For this reason, an urgent sternotomy was performed with drainage of a significant hemopericardial effusion, revealing a perforation of the upper free wall of the right atrium with pericardial injury caused by the retractable screw lead. The perforation site was sutured and the sternal wound was closed. The patient was discharged after 4 days without further complications. At the control visit, scheduled 30 days after the hospital discharge, the patient was in good conditions.ConclusionsAlthough the atrial perforations from leads are very rare complications of pacemaker implantation procedures, they are potentially lethal. In conclusion, this clinical case highlights the need, before hospital discharge, of an accurate screening for evaluation the pericardial effusion in patients that undergo to the cardiac implantable electronic devices.

Novel technique and assessment of available three-dimensional delivery sheath for endomyocardial biopsy during cardiac device implantation

BackgroundEarly cardiomyopathy diagnosis allows timely treatment and may help resolve problems that occur after cardiac implantable electronic device (CIED) implantation. ObjectiveTo describe a novel technique for endomyocardial biopsy (EMB) using a three-dimensional (3D) delivery sheath during CIED implantation. Additionally, we investigated 3D delivery sheath characteristics using sheath deflection during bioptome insertion. MethodsThis study of 20 patients undergoing CIED implantation analyzed the EMB success rate and pathological findings. Fluoroscopic images assessed 3D delivery sheath characteristics before and after bioptome insertion in three sheaths. CIEDs were implanted for sick sinus syndrome (n=3), atrioventricular conduction disorder (n=16), and left ventricular dysfunction (n=1). Fluoroscopic verification was performed using right anterior oblique (RAO) and left anterior oblique (LAO) views. EMB was performed with Selectra 3D (BIOTRONIK), CSP Locator 3D (Abbott) and SSPC (Boston Scientific) (12, 4, and 4 patients, respectively). The distance moved toward the right ventricular apex (RVA) in RAO was defined as Dis-RAO (mm) and that moved toward the RVA in LAO was defined as Dis-LAO (mm). ResultsAmong the three sheaths, only the CSP Locator 3D and Selectra 3D showed significant differences in Dis-RAO (13.2±2.0mm vs. 19.8±3.8mm, p<0.01) and Dis-LAO (8.1±1.3mm vs. 15.3±3.9mm, p<0.01). A total of 77 EMB samples from 20 patients were collected without any complication, and four patients (20%) were diagnosed with cardiac amyloidosis (CA) based on pathological findings. ConclusionsAll 3D delivery sheaths were safe and effective for performing EMB from the RVS during CIED implantation, enabling early CA diagnosis in 20% of patients.

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.

The feasibility and safety of Endomyocardial Biopsy by lumenless pacing lead-sheath directed method during the Cardiac Implantable Electronic Device implantation

The feasibility and safety of Endomyocardial Biopsy by lumenless pacing lead-sheath directed method during the Cardiac Implantable Electronic Device implantation

Ultrasound-Guided Axillary Access Using a Micropuncture Needle Versus Conventional Cephalic Venous Access for Implantation of Cardiac Devices: A Single-Center Randomized Trial

(1) Background: Ultrasound-guided axillary (USAX) vein puncture is a relatively new method to obtain venous access for the implantation of cardiac implantable electronic devices (CIED). However, its use is limited as most of the operators are not familiar with this technique. Our aim was to investigate the safety and efficacy of the USAX compared with the traditional cephalic vein dissection for venous access in CIED implantation. (2) Methods: This was a single-center, randomized, controlled, superiority trial. A total of 114 patients were randomized (1:1 ratio) to either USAX (u/s axillary group; 59 patients) or cephalic vein access (cephalic group; 55 patients). The primary study endpoint was defined as successful placement of all leads via the chosen access. Secondary study endpoints included time from local anesthetic injection to lead advancement in the SVC, total procedure time (skin to skin), procedure-related complications and pain perception. (3) Results: USAX was superior to cephalic access in terms of primary endpoint (OR: 4.3, 95% CI: 1.3, 14.0; p = 0.012). Total procedure duration was higher in the cephalic group (55.15 ± 16.62 vs. 48.35 ± 12.81 min, p = 0.017) but there was neither a significant difference in fluoroscopy time (p = 0.872) nor in total radiation dose (p = 0.815). The level of pain was higher in the cephalic group (p = 0.016), while the rates of complications were similar in both groups (p &gt; 0.05). (4) Conclusion: USAX was superior to cephalic access regarding success rate, total procedure duration and level of pain, while having no difference in complication rates.

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 &amp;lt;5 min) 24 (15.0%), Group 3 (≥5 min - &amp;lt;1h) 33 (20.6%), 19 (11.9%) patients in Group 4 (lasting ≥1 h - &amp;lt;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=&amp;lt;0.001). In Mann Whitney U test with Bonferronni correction, the median values of all other groups were significantly different from each other (p=&amp;lt;0.001). In the correlational analysis, there was a statistically significant positive relationship between AHRE duration and NSE values (r=0.842; p=&amp;lt;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=&amp;lt;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&amp;lt;0.001) and staphylococcus epidermidis (34.5% vs 15.6%; p&amp;lt;0.001) infections; nosohusial endocarditis (56.5% vs 20.9%; p&amp;lt;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&amp;lt;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) (&amp;gt;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 &amp;lt; 0.001) and clinically relevant VA (excluding NSVT) (pre: 21.5% vs post 8.7%; P &amp;lt; 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 &amp;lt; .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&amp;lt;0.001 and relevant VA: OR 0.30 (0,17-0,52); p&amp;lt;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&amp;lt;0.001) driven mainly by respiratory complications as well as in-hospital mortality (2.3% versus 1.2%; P&amp;lt;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&amp;lt;0.001). Most pocket hematomas were grade I for which watchful waiting was applied (1/32 (3.1%) vs 17/33 (51.6%), P&amp;lt;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 &amp;gt;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

Results of endoscopic electrode removal surgery in patients with cardiovascular implantable electronic devices

Introduction: The increasing popularity of permanent pacemakers and implantable cardioverter defibrillators (ICDs) has improved the quality of life and long-term prognosis of cardiovascular patients. However, there is also an increase in infections of cardiac implantable devices (CIEDs). The infection rate after the first implant is 4.82/1000 people, and after the device replacement is 12.12/1000. With the development of endoscopic techniques, a method of thoroughly treating infections of cardiac implantable devices is opened without increasing the severity of the patient’s condition. Method: Cross-sectional study, 08 patients with pacemaker infection underwent endoscopic surgery at the Cardiovascular Center, E Hospital from January 2020 to July 2024. Result: In 08 patients, the male ratio is mainly 06 patients, the oldest age was 85 years old and the youngest is 25 years old. There are 07 cases with permanent pacemaker implantation, 1 case of ICD placement Brugada syndrome. All cases have bacterial cultures: 05 patients have Staphylococcus aureus and 03 cases have cultured Staphylococcus epidermidis. All patients have pacemaker examination and underwent endoscopic surgery to remove the electrode. The average surgical time is 68,71± 18.3 minutes (97-40), in which 01 case has only electrode probe infection, the remaining cases has both the pacemaker and electrode probe infection. Most stable cases are discharged from hospital with an average time of 16,2± 7,8 days (11-30), 01 severe case due to sepsis in a patient with heart failure EF: 30%, kidney failure, diabetes, hypertension has to stay in treatment for additional 30 days. Conclusion: Endoscopic electrode removal surgery in patients with pacemaker infection initially achieved good results, with low complications and mortality, but a larger number of patients and long-term follow-up and evaluation are needed.

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.