ZEBRA study: The Z stitch Early Bed Rest Assessment study.

Background: Safe and effective management of venous vascular access is a key component of electrophysiology (EP) procedures. Recently, the Z-stitch method has been developed for effective venous hemostasis. However, the standard postprocedure protocol often includes prolonged bed rest, which may affect patient satisfaction. The ZEBRA (Z stitch Early Bed Rest Assessment) study aims to systematically investigate and quantify patient satisfaction metrics and safety parameters associated with the early mobilization after Z-stitch placement. Objective: This study primarily investigates whether early mobilization following Z-stitch placement in venous vascular access management during EP procedures enhances patient satisfaction without compromising safety. Methods: In this prospective, multicenter, randomized clinical trial, approximately 200 patients undergoing various EP procedures at Oregon Health and Science University and Veterans Affairs Portland Health Care System will be randomly assigned to either a 1- or 4-hour bed rest regimen post-Z stitch. Patient satisfaction will be assessed through survey, alongside monitoring for hematomas, bleeding complications, and other safety endpoints. The study includes stratification based on heparin administration and sheath size to ensure robust and nuanced data analysis. Results: We anticipate that early mobilization will lead to higher patient satisfaction scores. We also expect to closely monitor and report the incidence of hematomas, pain medication use, healthcare costs, patient outcomes at 30 days, time to ambulation, and hospital readmissions or emergency visits related to groin complications. Conclusion: The ZEBRA study is poised to fill a critical knowledge gap in postprocedure care in EP labs. By rigorously evaluating the impact of early mobilization on patient satisfaction and safety, this study could significantly influence future guidelines and improve patient experiences in EP procedures.

Out with the old: Single center experience with transvenous extraction of leads older than 15 years.

BACKGROUND: Lead dwell time is the single strongest predictor of failure and complications in transvenous lead extraction. OBJECTIVES: To report the success rate and complications of transvenous lead extractions with implant dwell time of at least 15 years. METHODS: Procedural and patient data were prospectively collected into a database. The excimer laser was the primary method for lead extraction with the use of mechanical rotational sheaths and femoral snares at operator discretion. RESULTS: A total of 442 patients between 2011 and 2020 underwent lead extraction (705 leads) primarily for infection or device failure at our high-volume center. Forty-one patients with 71 leads > 15 years old were included in this cohort. Mean patient age was 53.5 ± 18.5 years, 67.5% were male. Mean lead dwell time was 19.6 ± 4.4 years. Thirty-six of 41 (88%) patients had successful extraction of all leads compared to 96% in the remaining 401 patients, p value.004. Of the five patients without fully successful extractions two of these patients had abandoned leads (three total) that were clinically significant. There were two (4.9%) major complications in the very old lead group and six (1.5%) in the other group. In the very old lead group, one patient experienced right atrial appendage perforation requiring surgical repair and recovered well. One patient experienced new complete heart block requiring 2 min of CPR but did well thereafter. There was no procedure-related mortality. CONCLUSIONS: Despite challenges posed by older leads, very old leads can be safely and effectively extracted with low complication rates.

Impact of fixation mechanism and helix retraction status on right ventricular lead extraction.

Background: The impact of lead fixation mechanism on extractability is poorly characterized. Objective: We aimed to compare the technical difficulty of transvenous lead extraction (TLE) of active vs passive fixation right ventricular (RV) leads. Methods: A total of 408 patients who underwent RV TLE by a single expert electrophysiologist at Oregon Health & Science University between October 2011 and June 2022 were identified and retrospectively analyzed; 331 (81%) had active fixation RV leads and 77 (19%) had passive fixation RV leads. The active fixation cohort was further stratified into those with successfully retracted helices (n = 181) and failed helix retraction (n = 109). A numerical system (0-9) devised using 6 procedural criteria quantified a technical extraction score (TES) for each RV TLE. The TES was compared between groups. Results: Helix retraction was successful in ≥55% of active fixation TLEs. The mean TES for active-helix retracted, active-helix non-retracted, and passive fixation groups was 1.8, 3.5, and 3.7, respectively. The TES of the active-helix retracted group was significantly lower than those of the active-helix non-retracted group (adjusted P < .01) and the passive fixation group (adjusted P < .01). There was no significant difference in TES between the passive fixation and active-helix non-retracted groups in multivariate analysis (P = .18). The TLE success rate of the entire cohort was >97%, with a major complication rate of 0.5%. Conclusion: TLE of active fixation leads where helical retraction is achieved presents fewer technical challenges than does passive fixation RV lead extraction; however, if the helix cannot be retracted, active and passive TLE procedures present similar technical challenges.

Extract-stent-replace for treatment of upper baffle stenosis with pacing leads after atrial switch procedures for transposition of the great arteries: An approach to avoid "jailing" the lead.

INTRODUCTION: Venous stenosis is a late complication of the atrial switch (Mustard/Senning) procedure seen in patients with transposition of the great arteries ( d-TGA). Many atrial switch patients require cardiac implantable electronic devices (CIEDs) which further increases the incidence of venous stenosis. Stenosis of the superior limb of the systemic venous pathway (SLSVP) in the presence of CIED leads presents a management challenge. We propose a method for navigating SLSVP stenosis in atrial switch patients with CIEDs. METHODS: The pulse generator and leads were removed using standard extraction techniques. Axillary access was retained via existing leads or new access was obtained. The interventional cardiology team, via groin access, performed stent-angioplasty of the stenotic SLSVP. After stent deployment, the axillary access wire was snared from below, guided through the stent, and pulled into a long groin sheath. A sheath was then advanced over the axillary wire and into the groin sheath creating a path for passage of leads through the stent. New leads were advanced through the axillary sheath into the heart. Leads were secured using standard techniques. RESULTS: All patients had a history of d-TGA and prior atrial switch procedures. In each case, there was stenosis of the SLSVP in the setting of a CIED lead. There were no immediate complications and there was no restenosis on follow-up. CONCLUSION: Post-atrial switch patients with CIEDs can develop stenosis of the SLSVP. A collaboration between electrophysiology and interventional cardiology can allow for device extraction, stent-angioplasty, and lead reimplantation to avoid "jailing" the leads.

Magnetic resonance imaging in patients with cardiac implantable electronic devices: a single-center prospective study.

PURPOSE: Cardiac implantable electronic devices (CIEDs) have traditionally been a contraindication for magnetic resonance imaging (MRI). Recent studies suggest that MRI can be conducted safely in select patients with pacemakers (PPMs) and implantable cardioverter defibrillators (ICDs). We sought to determine the safety of MRI in patients with CIEDs, using a protocol for patient selection and device programming. METHODS: This is a prospective, single-center study. Patients with a PPM or ICD and a clinical indication for MRI were considered. Exclusion criteria included newly implanted devices (<4 weeks), PPMs manufactured before 1996 and ICDs before 2000, epicardial and abandoned leads, and pacemaker-dependent ICD patients. Pacemaker-dependent PPM patients were programmed to asynchronous pacing. Tachycardia detection/therapies were disabled for ICDs. Devices were interrogated pre- and post-scan, and at follow-up 1-6 weeks later. Defibrillation threshold (DFT) was not tested post-scan. Patients were followed to monitor device therapies. RESULTS: Two hundred twenty-seven patients underwent 293 scans. Devices included 170 (70.6%) PPMs and 71 (29.5%) ICDs. Thirteen (4.4%) scans were aborted mainly due to subjective complaints or artifact on scout cardiac imaging. Post-scan and follow-up interrogation demonstrated no changes in device parameters requiring reprogramming or revision. Over long-term follow-up (median, 354 days [IQR 65-629]), nine ICD patients had appropriate shocks (median, 3 [IQR 1-8]). One had four inappropriate shocks for atrial fibrillation. All tachyarrhythmias meeting criteria for defibrillation were successfully terminated. CONCLUSIONS: MRI can be conducted safely in patients with CIEDs when done in a protocoled manner with appropriate supervision. DFT testing after MRI may not be necessary.

Premature failure of a Riata defibrillator lead without impedance change or inappropriate sensing: a case report and review of the literature.

A 63-year-old woman with a St. Jude Medical Riata 1570 right ventricular lead complained of intermittent hiccups 2 months after implant. Interrogation revealed elevated pacing threshold and diaphragmatic stimulation. Pacing and shock lead impedances remained stable. No inappropriate sensing was noted. Fluoroscopic examination of the lead revealed a thin radio-opaque wire seen between the 2 defibrillator coils away from the main body of the lead. After extraction, a tear in the insulation of the lead was noted allowing the inner wire to protrude. This case illustrates a novel mechanism of insulation failure without inappropriate sensing or impedance change.