Pacing And Clinical Electrophysiology[JOURNAL]
Sun
200 papers
A Standardized Zero-Fluoroscopy, 3D-Guided Workflow for AVNRT Ablation With Same-Day Discharge: PICENO AVNRT Approach.
Marchese P, Gennaro F, Mazzotta G … +8 more , Cocchiara L, Crapisi G, Pratolongo C, Desiro D, Berardini FL, Shebabeddine K, Mirarchi M, Grossi P
Pacing Clin Electrophysiol · 2026 May · PMID 42205103 · Publisher ↗
INTRODUCTION: Slow-pathway ablation for atrioventricular nodal re-entrant tachycardia (AVNRT) is highly effective but carries a small risk of atrioventricular block. A fully standardized, safety-driven 3D-guided workflow...
INTRODUCTION: Slow-pathway ablation for atrioventricular nodal re-entrant tachycardia (AVNRT) is highly effective but carries a small risk of atrioventricular block. A fully standardized, safety-driven 3D-guided workflow tailored to AVNRT ablation has not been clearly defined. METHODS AND RESULTS: We retrospectively analyzed 150 consecutive day-hospital patients with invasive electrophysiological confirmation of AVNRT who underwent ablation using the standardized PICENO AVNRT approach between 2017 and 2025. The protocol integrates Koch's triangle pace mapping and voltage-bridge mapping to guide slow-pathway ablation. Acute success was achieved in 100% of patients. No transient or permanent AV block occurred. Fluoroscopy was not required in any case. Mean procedure time was 62 ± 14 min. At 30.5 ± 18.8 months of follow-up, one recurrence (0.7%) was observed. CONCLUSION: A standardized 3D-guided safety-driven workflow for AVNRT ablation is feasible and reproducible in a day-hospital setting, achieving excellent outcomes while eliminating fluoroscopy because of procedural reliability.
12-Month Clinical Outcomes Using a Variable-Loop Circular Catheter for PFA in a Chinese Atrial Fibrillation Population.
Tao H, Cai H, Fu H … +9 more , Liu S, Chen S, Gao L, Yin X, Xue Y, Liao H, Zeng R, Cui K, Dong J
Pacing Clin Electrophysiol · 2026 May · PMID 42205100 · Publisher ↗
BACKGROUND: The variable-loop circular catheter (VLCC) showed promising outcomes in European and US studies, but evidence is limited in Asian populations. afIRE trial assessed 12-month safety and effectiveness of the VLC...
BACKGROUND: The variable-loop circular catheter (VLCC) showed promising outcomes in European and US studies, but evidence is limited in Asian populations. afIRE trial assessed 12-month safety and effectiveness of the VLCC in Chinese patients with symptomatic, drug-refractory paroxysmal atrial fibrillation (AF). METHODS: AfIRE was a prospective, multicenter, single-arm trial for adults undergoing first-time pulmonary vein isolation (PVI) with the VLCC. Primary effectiveness was 12-month freedom from atrial arrhythmia recurrence (systematically assessed by electrocardiogram and Holter monitoring at 3-, 6-, and 12-months post-ablation or when symptomatic), repeat ablation, procedural failure, or Class I/III antiarrhythmic drug use. Safety was defined by incidence of primary adverse events (PAEs). RESULTS: Of 142 patients enrolled, 123 (mean age 57.0 years, 45.5% female) comprised the main-stage cohort (patients treated with the VLCC after roll in). Median procedure, pulsed field ablation (PFA), and fluoroscopy times were 115.0, 36.1, and 5.0 min, respectively. Acute PVI was achieved in all patients, with 89.4% without acute reconnection and 11.4% undergoing non-PV ablation. Twelve-month primary effectiveness success and freedom from symptomatic recurrence were 74.8% and 87.0%, respectively. Safety was favorable, with PAEs in 2 patients (1.6%; vascular complications; unlikely device-related). Multivariable analysis of the primary endpoint showed that preserved left ventricular ejection fraction (≥ 60%) was associated with 86% reduction in odds of 12-month atrial arrhythmia recurrence; diabetes, ≥ 9 symptomatic AF episodes, and < 48 valid PFA applications (16 ablations) numerically increased odds of recurrence. CONCLUSION: The first Asian VLCC experience demonstrated favorable 12-month effectiveness and excellent safety, reinforcing reproducibility across global AF populations. CLINICAL TRIAL REGISTRATION: NCT05552963.
Pulsed Field Ablation Integrated With 3D Mapping System for Pulmonary Vein Isolation in a Swine Model.
Gong Z, Lu Y, Shen C … +14 more , Zhou J, Tang X, Zhou T, Hu Y, Sun Y, Hu S, Feng M, Chen S, Yu L, Zhuo W, Zhang J, Ouyang F, Bai R, Chu H
Pacing Clin Electrophysiol · 2026 May · PMID 42189730 · Publisher ↗
BACKGROUND: Pulsed field ablation (PFA) is a breakthrough therapeutic modality for atrial fibrillation that employs nonthermal irreversible electroporation to selectively ablate cardiomyocytes. This preclinical study eva...
BACKGROUND: Pulsed field ablation (PFA) is a breakthrough therapeutic modality for atrial fibrillation that employs nonthermal irreversible electroporation to selectively ablate cardiomyocytes. This preclinical study evaluated the safety and efficacy of a novel PFA system for pulmonary vein isolation (PVI). OBJECTIVES: This study aimed to assess the safety and efficacy of a preclinical used PFA system in achieving acute and durable PVI. METHODS: The PFA system-comprising two flexible circular catheters, a three-dimensional mapping system (3DMS), and a pulsed field generator-was utilized for PVI. Bipolar, biphasic waveforms were delivered in six swine using a 7-electrode circular catheter at the right superior pulmonary vein (RSPV) and a 14-electrode catheter at the common inferior pulmonary vein (CIPV). All animals underwent repeat electrophysiological mapping immediately post-procedure and at 3-month follow-up to assess lesion durability and procedural safety, followed by gross necropsy and histology. RESULTS: All targeted pulmonary veins were successfully isolated. A total of 22.7 ± 5.3 applications were delivered per animal, comprising 11.0 ± 1.9 applications using the 7-electrode catheter and 11.7 ± 4.7 applications using the 14-electrode catheter. Acute and durable PVI at 3-month follow-up was achieved in all swine. Histopathology assessment revealed 100% of transmural fibrotic lesions with a mean depth of 2.7 ± 0.6 mm at RSPV and 3.3 ± 1.4 mm at CIPV (p = 0.372) with no evidence of inflammation, or thrombus formation. No ventricular arrhythmias occurred during PFA delivery, and no periprocedural adverse events were observed. Furthermore, no collateral damage-including esophageal injury or phrenic nerve paralysis-was detected at the 3-month evaluation. CONCLUSIONS: The 3DMS integrated PFA system demonstrated excellent acute and chronic efficacy in achieving PVI, with durable lesion formation and a favorable safety profile free from collateral tissue injury.
Early Intervention for Early Recurrence After Atrial Fibrillation Ablation: Is Atrial Remodeling the True Mechanism?
Kataoka N, Imamura T
Pacing Clin Electrophysiol · 2026 Jul · PMID 42189728 · Publisher ↗
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Compound Heterozygous SLC12A3 Variants in Gitelman Syndrome Presenting With Ventricular Fibrillation and Cardiac Arrest.
Kemal H, Ergoren MC, Koyutourk B … +2 more , Cerit L, Duygu H
Pacing Clin Electrophysiol · 2026 May · PMID 42189724 · Publisher ↗
BACKGROUND: Gitelman syndrome (GS) is an autosomal recessive salt-losing tubulopathy characterized by hypokalemia, hypomagnesemia, and metabolic alkalosis. Although often considered benign, GS may predispose to malignant...
BACKGROUND: Gitelman syndrome (GS) is an autosomal recessive salt-losing tubulopathy characterized by hypokalemia, hypomagnesemia, and metabolic alkalosis. Although often considered benign, GS may predispose to malignant ventricular arrhythmias. CASE PRESENTATION: A 41-year-old male presented with cardiac arrest due to ventricular fibrillation (VF). Severe hypokalemia (1.6 mmol/L) and hypomagnesemia were identified, with no structural heart disease on imaging. Recurrent VF persisted despite antiarrhythmic therapy and resolved only after electrolyte correction. Genetic testing revealed pathogenic SLC12A3 variants. CONCLUSION: GS can cause an electrical storm in structurally normal hearts; prompt recognition and electrolyte management are essential.
Clinical Superiority of Active Fixation Quadripolar Leads in Cardiac Resynchronization Therapy.
Yamanaka K, Murase Y, Inden Y … +7 more , Ikeda T, Mamiya K, Kano N, Imai H, Ogawa Y, Kawaguchi K, Murohara T
Pacing Clin Electrophysiol · 2026 May · PMID 42189717 · Publisher ↗
BACKGROUND: The effectiveness of cardiac resynchronization therapy (CRT) depends on stable and optimal left ventricular (LV) lead placement. The Attain Stability Quadripolar (ASQ) lead uses active fixation to improve per...
BACKGROUND: The effectiveness of cardiac resynchronization therapy (CRT) depends on stable and optimal left ventricular (LV) lead placement. The Attain Stability Quadripolar (ASQ) lead uses active fixation to improve performance. We aimed to assess the clinical superiority of ASQ leads over conventional quadripolar leads. METHODS: This single-center retrospective cohort study included 65 CRT recipients (31 ASQ, 34 non-ASQ). Primary endpoints were lead stability and CRT response at 6 months (relative LVESV reduction and absolute LVEF increase); secondary endpoints included pacing thresholds, QRS changes, and LV functional parameters. RESULTS: No intraoperative dislodgement occurred with ASQ leads, versus six cases (17.6%) in the non-ASQ group (p = 0.014). At 6 months, pacing thresholds were lower with ASQ (1.35 ± 0.81 V vs. 1.80 ± 0.77 V, p = 0.047). In patients with left bundle branch block, reverse remodeling as assessed by LVESV reduction was more frequent with ASQ (≥15%: 82% vs. 29%, p = 0.008; ≥30%: 64% vs. 21%, p = 0.032), and this was accompanied by greater improvement in LVEF (≥10 percentage points: 73% vs. 21%, p = 0.01; ≥20 points: 64% vs. 21%, p = 0.032). ASQ leads provided stable fixation across vessel diameters from 1.9-5.4 mm, including large veins >4.0 mm. CONCLUSIONS: ASQ leads offer superior stability, lower pacing thresholds, and higher CRT response, supporting wider use of active fixation technology in CRT.
Differential HFpEF Response After Catheter Ablation in Persistent AF Patients With Small Low Voltage Areas.
Egami Y, Mukai T, Kise M … +10 more , Kobayashi N, Sugino A, Abe M, Nohara H, Kawanami S, Yasumoto K, Okamoto N, Matsunaga-Lee Y, Yano M, Nishino M
Pacing Clin Electrophysiol · 2026 May · PMID 42189702 · Publisher ↗
BACKGROUND: Low voltage areas (LVAs) in the left atrium (LA) is associated with atrial fibrillation (AF) recurrence and heart failure with preserved ejection fraction (HFpEF). The clinical significance of small LVAs (< 5...
BACKGROUND: Low voltage areas (LVAs) in the left atrium (LA) is associated with atrial fibrillation (AF) recurrence and heart failure with preserved ejection fraction (HFpEF). The clinical significance of small LVAs (< 5.0 cm) in patients with persistent atrial fibrillation (PerAF) remains unclear. This study evaluated the impact of catheter ablation (CA) on HFpEF status in PerAF patients with small LVAs. METHODS: We included 62 consecutive PerAF patients with total LA LVAs < 5.0 cm undergoing initial CA between June 2019 and March 2023. Patients were divided by the median LVA into the sLVA-Low (0.0-1.6 cm) and sLVA-High (1.7-4.9 cm). HFA-PEFF scores were assessed at baseline and 12 months. Changes in HFA-PEFF scores (ΔHFA-PEFF), arrhythmia recurrence, and adverse clinical events were compared. RESULTS: Baseline HFA-PEFF scores were higher in sLVA-High than in sLVA-Low (4 [3-4] vs. 2 [2-3], p = 0.013). At 12 months, HFA-PEFF scores remained elevated in sLVA-High (3.5 [2-5] vs. 2 [2-4], p = 0.037), with a greater prevalence of HFA-PEFF scores 5-6 (30% vs. 8%, p = 0.043). However, ΔHFA-PEFF scores, AF recurrence rates, the incidence of adverse events did not differ significantly between the two groups. CONCLUSION: Among PerAF patients with small LVAs (<5 cm), relatively larger LVAs within the small range were associated with worse HFpEF profiles despite similar rhythm outcomes. Even small LVAs may indicate substrate prone to HFpEF progression, warranting careful follow-up.
Healthcare Utilization and Use of Implantable Cardiac Monitors in Syncope of Unknown Origin.
Blasutti S, Zhang M, Ng S … +1 more , Wilsmore B
Pacing Clin Electrophysiol · 2026 May · PMID 42173812 · Publisher ↗
BACKGROUND: Syncope of unknown origin ('SUO') is a challenge for clinicians. Investigation and admission rates vary despite attempts at standardization. Implantable cardiac monitors (ICMs) are valuable in streamlining wo...
BACKGROUND: Syncope of unknown origin ('SUO') is a challenge for clinicians. Investigation and admission rates vary despite attempts at standardization. Implantable cardiac monitors (ICMs) are valuable in streamlining work-up for SUO. OBJECTIVES: Compare admission rates in SUO in our ED to European Society of Cardiology ('ESC') 2018 guidelines and Canadian Syncope Risk Score ('CSRS') recommendations. Secondary outcomes included assessing clinician adherence to ESC and CSRS, differences between admission rates and syncope recurrence across age and gender, and healthcare utilization and outcomes over 24-months including ICM insertion when indicated. METHODS: Retrospective review of 50 patients with SUO in 2020. Admission rates were compared to the ESC and CSRS recommendations for significance. ICM was indicated for recurrent SUO > 30 days apart. RESULTS: Admission rates (64%) weren't significantly higher than ESC (60%) or CSRS (54%). Adherence was 83%-89% for admissions and 65% for discharges. Admitted patients were older with no difference in recurrence. Gender differences for admission rates or recurrence weren't significant. Admissions were diagnostic for 25%. Rates of most investigations were reduced compared to prior studies. 26% suffered recurrence and 10% injuries. ∼20% of patients met indications for ICM, and 89% meeting criteria received one. CONCLUSIONS: Our study shows no difference in admission rates in SUO compared to ESC or CSRS with 83%-89% adherence for admissions, and 65% for discharge, high diagnostic yield (25%) for admissions and reduced low-yield investigations with appropriate use of ICMs as an early investigation for recurrent SUO.
Magnetic Resonance Imaging Safety in Patients With Conditional Mixed-Manufacturer Devices.
Tashakkor RM, Zamanian K, Scott N … +3 more , Farhoumand S, Hernandez M, Tashakkor B
Pacing Clin Electrophysiol · 2026 May · PMID 42171269 · Publisher ↗
BACKGROUND: Magnetic resonance imaging (MRI) is a critical diagnostic tool known for its non-invasive nature and high-resolution imaging capabilities. However, its safety in patients with cardiac implantable electronic d...
BACKGROUND: Magnetic resonance imaging (MRI) is a critical diagnostic tool known for its non-invasive nature and high-resolution imaging capabilities. However, its safety in patients with cardiac implantable electronic devices (CIEDs), particularly those with mixed-lead systems, remains a significant clinical concern. This report investigates the safety and efficacy of MRI in such patients, where generators and leads originate from different manufacturers and are not officially deemed MRI-conditional. METHODS: A retrospective, non-randomized single center study was conducted involving 16 patients with mixed company lead CIEDs that obtained 23 MRIs. All patients underwent clinically indicated 1.5 Tesla MRI scans between July 2021 and August 2025. RESULTS: Pre- and post-scan measurements included lead impedance, sensing thresholds, and battery voltage, along with monitoring for clinical complications such as arrhythmias, syncope, or cardiac arrest. No adverse effects or device malfunctions were observed, and all key parameters remained stable post-scan. CONCLUSION: This study shows the safe use of MRIs for patients with mixed-lead CIEDs.
Pacing-Induced Cardiomyopathy in Leadless and Transvenous Pacemakers: A Meta-Analysis and Meta-Regression.
Wijayanto FPS, Simanjuntak AMT, Tristan CD … +3 more , Undarsa AC, Lukito AA, Pranata R
Pacing Clin Electrophysiol · 2026 May · PMID 42171073 · Publisher ↗
BACKGROUND: Leadless pacemakers have been developed to reduce complications associated with transvenous systems; however, their impact on pacing-induced cardiomyopathy (PICM) remains uncertain. This study aimed to evalua...
BACKGROUND: Leadless pacemakers have been developed to reduce complications associated with transvenous systems; however, their impact on pacing-induced cardiomyopathy (PICM) remains uncertain. This study aimed to evaluate the prevalence of PICM following leadless pacing, compared PICM risk with transvenous pacing, and assessed cardiac resynchronization therapy (CRT) upgrade. METHODS: This systematic review and meta-analysis followed PRISMA guidelines. PubMed, Scopus, and ScienceDirect were searched up to January 2026. Studies reporting PICM following leadless pacing or comparing leadless and transvenous systems were included. Random-effects models estimated pooled prevalence and risk ratios (RRs), and meta-regression explored potential modifiers. RESULTS: Eight studies comprising 3224 patients with leadless pacing were included. The pooled prevalence of PICM following leadless pacing was 13% (95%CI: 4%-23%; I = 92%). In comparative analysis (5 studies; n = 6025), the risk of PICM was similar between leadless and transvenous pacing (RR 1.00; 95%CI: 0.77-1.29; I = 52%). Leadless pacing was associated with a lower observed rate of CRT upgrade (RR 0.56; 95%CI: 0.48-0.66; I = 42%), although this finding should be interpreted cautiously because it may reflect patient selection, procedural factors, and differing thresholds for CRT upgrade. Meta-regression identified baseline heart failure (HF) as a significant predictor of PICM (p < 0.0001). CONCLUSION: Leadless pacemakers demonstrate a non-inferior risk of PICM and similar safety profiles to transvenous systems, while a lower observed rate of CRT upgrade. Future studies should standardize PICM definitions and improve reporting of pacing burden, ventricular function, and patient-level outcomes.
Nifekalant-Magnesium Cocktail for Chemical Cardioversion of Atrial Flutter: A Multicenter Pilot Study.
Sairaku A, Amioka M, Watanabe Y … +3 more , Tomomori S, Fukuda Y, Nakano Y
Pacing Clin Electrophysiol · 2026 May · PMID 42165177 · Publisher ↗
BACKGROUND: Pharmacologic cardioversion of atrial flutter (AFL) remains challenging, particularly in older or frail patients who are not candidates for catheter ablation. Nifekalant is effective for AFL but is limited by...
BACKGROUND: Pharmacologic cardioversion of atrial flutter (AFL) remains challenging, particularly in older or frail patients who are not candidates for catheter ablation. Nifekalant is effective for AFL but is limited by QT prolongation and the risk of torsades de pointes (TdP). Magnesium sulfate may mitigate this risk. METHODS: In this multicenter, investigator-initiated pilot study, 86 patients with symptomatic persistent AFL received intravenous magnesium sulfate followed by nifekalant. The primary outcome was AFL termination within 60 min. Time to termination and safety outcomes, including TdP, were assessed. Multivariable logistic regression analyses were performed to identify factors associated with AFL termination. RESULTS: AFL terminated in 42 patients (48.8%). Among patients with successful cardioversion, 80% achieved termination within 20 min. Larger left atrial diameter was associated with a lower likelihood of AFL termination. Adverse events occurred in 2 patients (2.3%), including sinus pauses requiring pacemaker implantation and transient hypotension requiring vasopressor support. No cases of TdP were observed. CONCLUSIONS: These findings suggest that the nifekalant-magnesium cocktail may be a feasible and potentially safe option for chemical cardioversion of AFL, warranting further investigation in larger studies.
Empiric and Trigger-Guided Superior Vena Cava Isolation in AF Ablation: Systematic Review and Meta-Analysis.
Sehrawat O, Garg V, Foo CY … +6 more , Xue C, Khandekar N, Matai P, Asirvatham S, Siontis KC, Noseworthy PA
Pacing Clin Electrophysiol · 2026 May · PMID 42154216 · Publisher ↗
BACKGROUND: Superior vena cava isolation (SVCI) is performed as an adjunct to pulmonary vein isolation (PVI) for atrial fibrillation, yet whether an empiric or trigger-guided strategy is preferable remains uncertain. Pri...
BACKGROUND: Superior vena cava isolation (SVCI) is performed as an adjunct to pulmonary vein isolation (PVI) for atrial fibrillation, yet whether an empiric or trigger-guided strategy is preferable remains uncertain. Prior meta-analyses have been largely restricted to index procedures in paroxysmal AF and have not explicitly stratified by ablation strategy. We sought to address these gaps through a systematic review of available randomized evidence. METHODS: Major databases were searched through November 2025 for RCTs comparing PVI+SVCI versus PVI alone. Trials were stratified by strategy: empiric SVCI (performed irrespective of SVC ectopy) or trigger-guided SVCI (performed only upon demonstrated SVC triggers). The primary outcome was atrial tachyarrhythmia recurrence (≥30 s) beyond the blanking period. Random-effects models, pre-specified subgroup analyses, meta-regression, and GRADE certainty assessment were performed. RESULTS: Eight RCTs (n = 1231) were included; most enrolled paroxysmal AF, while two incorporated non-paroxysmal AF subtypes and one evaluated repeat ablation procedures. Overall, SVCI+PVI significantly reduced recurrence versus PVI alone (97/604 vs. 135/627; RR 0.77, 95% CI 0.61-0.97; p = 0.03; I = 0%). On stratified analysis, empiric SVCI demonstrated a significant recurrence reduction (RR 0.70, 95% CI 0.53-0.92; p = 0.01; I = 0%), while trigger-guided SVCI did not reach statistical significance (RR 0.80, 95% CI 0.37-1.74; p = 0.57; I = 52%). In paroxysmal AF (n = 1038), adjunctive SVCI significantly reduced recurrence compared with PVI alone (RR 0.68, 95% CI 0.52-0.90; p = 0.01; I = 0%). Fluoroscopy time was longer with SVCI; total procedure duration was comparable. Major complications were infrequent but numerically higher with SVCI+PVI (15/604 vs. 7/627; RR 1.96, 95% CI 0.87-4.38; p = 0.10). Meta-regression identified no significant effect modifiers. GRADE certainty was high for overall and empiric analyses, and moderate for trigger-guided SVCI. CONCLUSIONS: Empiric SVCI significantly reduced AT/AF recurrence as an adjunct to PVI, while trigger-guided SVCI did not demonstrate a significant benefit. These findings suggest SVC isolation confers benefit independent of prior trigger documentation, supporting the role of empiric SVCI as an adjunct to AF ablation.
Prior Stroke Increases Residual Shunt Risk After Combined Ablation and LAAO: A Device-Specific Interaction.
Ren H, Lai H
Pacing Clin Electrophysiol · 2026 May · PMID 42143608 · Publisher ↗
BACKGROUND: The safety and efficacy profile of the combined "one-stop" catheter ablation (CA) and left atrial appendage occlusion (LAAO) procedure in atrial fibrillation (AF) patients with a prior history of cerebral inf...
BACKGROUND: The safety and efficacy profile of the combined "one-stop" catheter ablation (CA) and left atrial appendage occlusion (LAAO) procedure in atrial fibrillation (AF) patients with a prior history of cerebral infarction requires further validation. METHODS: In this retrospective, single-center study, 242 consecutive AF patients undergoing the one-stop procedure were categorized into Stroke (n = 103) and Non-Stroke (n = 139) groups. A 1:1 propensity score matching (PSM) was performed, yielding 57 balanced pairs. The primary efficacy endpoint was procedural success. Key safety endpoints included post-procedural residual shunt assessed at 45 days, device-related thrombosis (DRT), and stroke recurrence. RESULTS: After PSM, baseline characteristics were well-balanced. Procedural success (91.2% vs. 87.7%, p = 0.484) and freedom from AF recurrence (88.6% vs. 89.3%, p = 0.979) were comparable between Stroke and Non-Stroke groups. However, the incidence of residual shunt was significantly higher in the Stroke group (5.3% vs. 0%, p = 0.028). No significant differences were observed in DRT or stroke recurrence rates. Notably, a significant interaction was found between prior stroke and LAAO device type on residual shunt risk (p-for-interaction = 0.045), indicating the risk varied substantially depending on the occluder used. CONCLUSION: A history of prior stroke does not impair the procedural success or mid-term rhythm control of the one-stop CA+LAAO strategy. However, it is associated with an increased risk of residual shunt, a relationship significantly modified by the type of occluder device. These findings highlight the potential need for individualized device selection in stroke survivors.
Infection of Cardiac Implantable Electronic Devices in Low and Middle Income Countries: A Systematic Review.
G V, Sundaram PS, V M
Pacing Clin Electrophysiol · 2026 May · PMID 42143606 · Publisher ↗
BACKGROUND: Cardiac implantable electronic devices (CIEDs), including pacemakers, implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices, are increasingly used in low- and mid...
BACKGROUND: Cardiac implantable electronic devices (CIEDs), including pacemakers, implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices, are increasingly used in low- and middle-income countries (LMICs). However, device-related infections remain a significant complication, leading to increased morbidity, mortality, and healthcare burden. Evidence from LMICs is limited and fragmented. OBJECTIVE: To systematically review the incidence, microbiological profile, management strategies, and clinical outcomes of CIED-related infections in LMICs. METHODS: A comprehensive literature search was conducted across PubMed and Google Scholar up to September 2025. Studies from LMICs reporting on CIED-related infections were included. Data on infection rates, device types, reuse practices, microbiology, and outcomes were extracted and synthesized. RESULTS: Fifty-five studies encompassing 96 448 CIED recipients were included. A total of 1910 infected patients were analyzed, yielding an overall infection rate of 1.65%. Infection rates ensuing reused CIED implantation (1.82%) are not consistently higher than those reported for new devices. Infection risk was higher with complex devices-5.9% in CRTs and 4.74% in ICDs-compared to 1.75% in pacemakers. Replacement and revision procedures had significantly higher infection rates (2.1%) than de novo implantations (0.57%). Among 1063 infections with available microbiological data, coagulase-negative Staphylococci (26.0%) and Staphylococcus aureus (25.4%) were predominant, though 35.4% were culture-negative. Device extraction was performed in 75% of treated patients. Infection-related mortality was 8.87%, and long-term follow-up data were limited. CONCLUSION: CIED infections in LMICs occur at higher rates than in high-income settings, particularly with complex devices and reinterventions. Culture-negative infections are common, and access to guideline-recommended care, including device extraction, is often limited.
Association Between Micra Transcatheter Pacing System Curvature and Capture Threshold During Implantation.
Xing Q, Tuerhong Z, Guo R … +5 more , Xiaokereti J, Zhang J, Li Y, Zhou X, Tang B
Pacing Clin Electrophysiol · 2026 May · PMID 42142311 · Publisher ↗
BACKGROUND: No previous studies have examined the relationship between Micra transcatheter pacing system (TPS) curvature and acceptable thresholds during implantation. This study aimed to evaluate the association between...
BACKGROUND: No previous studies have examined the relationship between Micra transcatheter pacing system (TPS) curvature and acceptable thresholds during implantation. This study aimed to evaluate the association between Micra TPS curvature and pre-deployment capture thresholds. METHODS: The Micra TPS was successfully implanted with the assistance of right ventriculography in 180 patients. The curvature of the Micra TPS prior to deployment was analyzed using archived right anterior oblique (RAO) images from the first deployment, with the aid of Origin software (OriginLab Corporation, USA), while electrical parameters were recorded from 0 to 30 min at 10-min intervals. RESULTS: Among 159 eligible patients, 126 (79.2%) demonstrated acceptable thresholds with a mean curvature of 0.58 ± 0.18. The high-threshold group (n = 33, 20.8%) exhibited significantly greater curvature (1.36 ± 0.64). Receiver operating characteristic analysis indicated that Micra TPS curvature ≤0.799 predicted acceptable thresholds with 90.9% sensitivity and 91.3% specificity (area under the curve = 0.958, 95% confidence interval: 0.924-0.992), with stable thresholds maintained in the acceptable group. No procedural complications occurred. CONCLUSIONS: A curvature of ≤0.799 in the RAO view of the Micra TPS prior to deployment reliably indicates acceptable capture thresholds. Combining curvature assessment with right ventriculography enhances the procedural safety of Micra implantation.
Remote Monitoring of Implantable Loop Recorders in Syncope Patients: Management of High Volume of Transmissions.
Oinonen A, Torvinen E, Marjamaa A … +5 more , Jäntti T, Parry M, Karvonen J, Raatikainen P, Sane M
Pacing Clin Electrophysiol · 2026 May · PMID 42142309 · Publisher ↗
BACKGROUND: Implantable loop recorder (ILR) is among the first line diagnostic tools in patients with unexplained syncope. When ILRs are followed with remote monitoring (RM) diagnosis can be established readily. However,...
BACKGROUND: Implantable loop recorder (ILR) is among the first line diagnostic tools in patients with unexplained syncope. When ILRs are followed with remote monitoring (RM) diagnosis can be established readily. However, the challenge in RM is the substantial workload related to false positive findings. The aim of this study was to evaluate the impact of symptom base scheduled monitoring (SBSM) on the efficacy and safety on follow-up of patients with unexplained syncope and large number of nonactionable RM transmissions. METHODS: The data of all patients (n = 176) with ILR implantation due to unexplained syncope from first of January 2021 to 31st of December 2024 were collected. Symptom based scheduled monitoring (SBSM), where the alert transmissions were replaced by scheduled quarterly and symptom-triggered transmissions, was introduced after 3 months alert-based follow-up in patients with a high burden of nonactionable transmissions. RESULTS: Mean age of the patients was 60 ± 17 years (56% female). ILR monitoring led to diagnosis in 34 % of the patients. Median time to diagnosis was 84 days (18-216 days) and the therapy included a pacemaker or an ICD implantation in 85% of them. SBSM was used in 18% of the patients. It was associated neither with an increased need for emergency room visits (p = 0.6) nor with hospitalization (p = 0.8). With SBMS the number of monthly RM transmissions decreased almost 80% from 1.5 to 0.3 transmission/device (p = 0.001). CONCLUSIONS: Our data indicates that the burden related to the non-actionable ILR alerts can be significantly reduced with SBMS without compromising patient safety. CAPSULE SUMMARY: Implantable loop recorders (ILRs) enable prompt diagnosis in patients with unexplained syncope. Unfortunately, they also generate a deluge of false-positive alerts. However, turning off alerts in patients with the highest burden of nonactionable transmissions can reduce the remote-monitoring workload without compromising patient safety.
Safety and Performance of INVICTA DF4 Ventricular Defibrillation Lead: Results From APOLLO Prospective Multicenter Study.
Witte KK, Martínez JG, Oliveira MM … +11 more , Barrera A, Izquierdo M, Mandurino C, Trucco ME, García Salvador JJ, Dompnier A, Jean F, Millán PJS, Israel C, Martino M, Marques P
Pacing Clin Electrophysiol · 2026 May · PMID 42142287 · Publisher ↗
BACKGROUND: Implantable cardioverter-defibrillator (ICD) therapy relies on reliable right ventricular leads for pacing, sensing, and defibrillation. The INVICTA DF4 lead is an active-fixation, quadripolar design intended...
BACKGROUND: Implantable cardioverter-defibrillator (ICD) therapy relies on reliable right ventricular leads for pacing, sensing, and defibrillation. The INVICTA DF4 lead is an active-fixation, quadripolar design intended to optimize implant workflow and long-term safety and performance. METHODS: APOLLO was a prospective, multicenter, single-arm, observational study enrolling adults across Europe with guideline-based indications for de novo ICD or Cardiac Resynchronization Therapy Defibrillator (CRT-D) implantation who received an INVICTA DF4 lead (single- or dual-coil; 58 or 68 cm). The co-primary endpoints focused on safety and performance at 3 months, while secondary endpoints included long-term electrical variables, arrhythmia termination, and lead-related complications through 24 months. RESULTS: Between June 4, 2021, and October 19, 2022, 446 patients were implanted across 45 sites in 8 European countries. The INVICTA lead was successfully implanted in 100% of the 446 enrolled patients. Leads were positioned either in the apex in 57.2% or right ventricle (RV) septum in 42.8%. Electrical variables stabilized after discharge and remained stable up to 24 months (M24 mean pacing threshold 0.85 ± 0.33 V at 0.5 ms; sensing 13.39 ± 3.17 mV; pacing impedance 525.5 ± 94.2 Ohms; right ventricular (RV) coil continuity 427.8 ± 82.7 Ohms). Of 86 arrhythmic episodes requiring defibrillation, 97.7% were successfully terminated. Lead-related complication free rate was 97.5% at 30 days, 98.9% at 31-730 days, and 96.4% overall. Mortality was 8.5% (38/446) at two years, of which 63% was due to cardiovascular causes. CONCLUSIONS: In a large, contemporary European cohort, the INVICTA DF4 ventricular lead demonstrated high implant success, durable electrical performance, effective arrhythmia termination, and low complication rates through 24 months. A trend toward less complication in septal positioning was observed compared to apical placement, with comparable electrical performance.
Safety and Efficacy of a Novel Radiofrequency Wire-Based Transseptal Puncture System.
Wardak FA, Fernandez AG, Paisey JR … +3 more , Bowers RW, Yue AM, Ullah W
Pacing Clin Electrophysiol · 2026 May · PMID 42142284 · Publisher ↗
BACKGROUND: Transseptal puncture (TSP) is a key component of cardiac ablation and structural interventional procedures. Procedural efficacy and safety of the VersaCross TSP platform, a novel blunt radiofrequency (RF)-wir...
BACKGROUND: Transseptal puncture (TSP) is a key component of cardiac ablation and structural interventional procedures. Procedural efficacy and safety of the VersaCross TSP platform, a novel blunt radiofrequency (RF)-wire based system, was compared with conventional equipment. METHODS: Consecutive patients undergoing TSP with VersaCross or a control group using conventional equipment were studied. Procedures were carried out using fluoroscopy alone or with additional transesophageal echocardiography (TEE) or intracardiac echocardiography (ICE) guidance. Procedural metrics including TSP and fluoroscopy times were recorded. Complications, both acute and up to a month post procedure, were included. RESULTS: Two hundred and fifty procedures were included (150 VersaCross, 100 control) in the registry. Of these, 100 consecutive cases (75 VersaCross, 25 control) had prospective data collected for procedural metrics. Between the VersaCross and control cases, there was no difference between echocardiographic use (50 vs. 52%, p = 0.8) or conscious sedation use (53 vs. 55%, p = 0.56). AF ablations predominated in both groups (81% vs. 90%). There was no difference between median TSP or fluoroscopy times for either single or double transseptal access between groups. There were five minor (one momentary AV-block and four acute pericardial effusions not requiring intervention) and two major (cardiac tamponade and hemothorax) complications in the VersaCross group, with two major (cardiac tamponade) complications in the control group. CONCLUSIONS: The VersaCross TSP system can be used in a variety of ablation procedures with or without TEE/ICE guidance under conscious sedation or general anesthesia. Compared with conventional TSP technologies, there is no increase in major complications, TSP or fluoroscopy times.
Recurrent Takotsubo Syndrome After Pacemaker Implantation.
Wang R, Xia T, Liang Y … +2 more , Sun L, Gu X
Pacing Clin Electrophysiol · 2026 May · PMID 42132897 · Publisher ↗
BACKGROUND: Takotsubo syndrome (stress cardiomyopathy) is a reversible ventricular systolic dysfunction presenting as acute heart failure, typically precipitated by emotional or physical stress. It features transient api...
BACKGROUND: Takotsubo syndrome (stress cardiomyopathy) is a reversible ventricular systolic dysfunction presenting as acute heart failure, typically precipitated by emotional or physical stress. It features transient apical ballooning or regional wall-motion abnormalities and often requires distinction from acute coronary syndrome. Although episodes soon after pacemaker implantation are described, recurrence within three months of apparent recovery is rare. CASE SUMMARY: We report a case of a patient who underwent dual-chamber pacemaker implantation for atrioventricular block. One day after discharge, the patient developed acute heart failure and was subsequently diagnosed with previously undiagnosed stress cardiomyopathy. After recovery from the initial episode, the patient experienced a recurrence of stress cardiomyopathy three months later. DISCUSSION: This case illustrates very early, procedure-associated Takotsubo syndrome with short-interval recurrence. Recognition in the peri-implant setting is crucial, as management is supportive and outcomes hinge on timely echocardiography, exclusion of acute coronary syndrome, and structured follow-up. TAKE-HOME MESSAGES: Consider Takotsubo syndrome in peri-implant decompensation after pacemaker implantation; obtain early bedside echocardiography and selective coronary evaluation. Manage with obstruction-aware supportive care; continue RAS blockade after discharge and ensure structured follow-up, as recurrence can occur despite guideline-concordant therapy.
Complications of Temporary Transvenous Cardiac Pacing by Access Site: A Systematic Review and Meta-Analysis.
Pereira RA, Barcellos G, Lenz G … +4 more , Tumelero M, Collin B, Peruzzo N, Gordon D
Pacing Clin Electrophysiol · 2026 May · PMID 42132883 · Publisher ↗
INTRODUCTION: The femoral and internal jugular veins are the most commonly used access routes for TTVPM placement. Femoral access is associated with higher rates of infection and bleeding due to groin proximity, whereas...
INTRODUCTION: The femoral and internal jugular veins are the most commonly used access routes for TTVPM placement. Femoral access is associated with higher rates of infection and bleeding due to groin proximity, whereas jugular access may increase the risk of vascular injury or pneumothorax when performed without imaging guidance. Despite numerous observational studies comparing these access sites, the evidence remains inconclusive due to heterogeneous methodologies, small sample sizes, and varying definitions of complications. To address these limitations, we conducted a meta-analysis to compare the relative safety and effectiveness of jugular versus femoral access for TTVPM placement. METHODS: A comprehensive search of PubMed, Embase, and Cochrane was performed from June 28, 2025, without language restrictions. Eligible studies included adult patients (≥18 years) undergoing TTVPM placement and directly comparing femoral and jugular venous access. Trials were considered if they reported at least one of the following outcomes: bleeding, infection, lead repositioning, cardiac perforation, or other major procedural complications. RESULTS AND DISCUSSION: Six observational studies published between 2013 and 2024 met the inclusion criteria and encompassed 2,267 patients from diverse clinical settings. Bleeding complications were reported in five studies (n = 1,457), showing no statistically significant difference between access sites (RR 0.54; 95% CI 0.18-1.60; p = 0.27). Four studies (n = 528) reported catheter-related infections, demonstrating a significantly lower risk with jugular access (RR 0.25; 95% CI 0.11-0.53; p = 0.0003). Lead repositioning (RR 0.73; p = 0.46) and cardiac perforation (RR 0.50; p = 0.33) showed no significant differences. CONCLUSION: Jugular venous access for TTVPM placement is associated with a significantly lower risk of catheter-related infections compared with femoral access, while rates of bleeding, lead repositioning, and cardiac perforation do not significantly differ between approaches. Jugular access may be preferred for patients expected to require prolonged pacing or those at high infection risk, whereas femoral access remains reasonable for short-term or emergent indications.
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