Lead Revision Research Articles

Risk profiles and outcomes of patients receiving antibacterial cardiovascular implantable electronic device envelopes: A retrospective analysis.

BACKGROUNDCardiovascular implantable electronic devices (CIEDs) are implanted in an increasing number of patients each year, which has led to an increase in the risk of CIED infection. Antibacterial CIED envelopes locally deliver antibiotics to the implant site over a short-term period and have been shown to reduce the risk of implant site infection. These envelopes are derived from either biologic or non-biologic materials. There is a paucity of data examining patient risk profiles and outcomes from using these envelope materials in the clinical setting and comparing these results to patients receiving no envelope with their CIED implantation.AIMTo evaluate risk profiles and outcomes of patients who underwent CIED procedures with an antibacterial envelope or no envelope.METHODSAfter obtaining Internal Review Board approval, the records of consecutive patients who underwent a CIED implantation procedure by a single physician between March 2017 and December 2019 were retrospectively collected from our hospital. A total of 248 patients within this period were identified and reviewed through 12 mo of follow up. The CIED procedures used either no envelope (n = 57), a biologic envelope (CanGaroo®, Aziyo Biologics) that was pre-hydrated by the physician with vancomycin and gentamicin (n = 89), or a non-biologic envelope (Tyrx™, Medtronic) that was coated with a resorbable polymer containing the drug substances rifampin and minocycline by the manufacturer (n = 102). Patient selection for receiving either no envelope or an envelope (and which envelope to use) was determined by the treating physician. Statistical analyses were performed between the 3 groups (CanGaroo, Tyrx, and no envelope), and also between the No Envelope and Any Envelope groups by an independent, experienced biostatistician. RESULTSOn average, patients who received any envelope (biologic or non-biologic) were younger (70.7 ± 14.0 vs 74.9 ± 10.6, P = 0.017), had a greater number of infection risk factors (81.2% vs 49.1%, P < 0.001), received more high-powered devices (37.2% vs 5.8%, P = 0.004), and were undergoing more reoperative procedures (47.1% vs 0.0%, P < 0.001) than patients who received no envelope. Between the two envelopes, biologic envelopes tended to be used more often in higher risk patients (84.3% vs 78.4%) and reoperative procedures (62.9% vs 33.3%) than non-biologic envelopes. The rate of CIED implant site pocket infection was low (any envelope 0.5% vs no envelope 0.0%) and was statistically equivalent between the two envelope groups. Other reported adverse events (lead dislodgement, lead or pocket revision, device migration or erosion, twiddler’s syndrome, and erythema/fever) were low and statistically equivalent between groups (biologic 2.2%, non-biologic 3.9%, no envelope 1.8%). CONCLUSIONCIED infection rates for biologic and non-biologic antibacterial envelopes are similar. Antibacterial envelopes may benefit patients who are higher risk for infection, however additional studies are warranted to confirm this.

Is sacral neuromodulation effective in patients with Parkinson's disease? A retrospective review.

Parkinson's disease (PD) is the second-most common degenerative neurologic disease worldwide. Overactive bladder (OAB) is prevalent in this population but can be challenging to treat. Sacral neuromodulation (SNM) is an attractive option but remains understudied. We have utilized SNM in PD patients and herein describe our outcomes. We performed a retrospective chart review of PD patients who underwent peripheral nerve evaluation (PNE) or Stage 1 SNM from 2000 to 2020. The primary outcome was progression to a permanent implant. The impact of PD stage and preprocedural urodynamic (UDS) parameters on test-phase outcome were investigated. Long-term efficacy was assessed using Wilcoxon matched-pairs test looking at a change in urinary symptoms (frequency, nocturia, incontinence episodes, and pad use) documented at follow-up visits and further need for treatment. Thirty-four patients underwent test phase SNM (7 PNE and 27 Stage 1). Median follow-up was 11 (interquartile range 5.8-29.8) months. Indications included refractory OAB (30/34) and nonobstructive urinary retention (4/34). Overall, 82% (28/34) of patients proceeded to a permanent implant. 71% (5/7) of PNEs were successful. Test-phase success did not differ based on PD disease severity or UDS parameters. In patients with OAB/urgency incontinence who progressed to the permanent implant, there was a statistically significant improvement in their urinary symptoms from baseline. Most (68%) patients were able to discontinue OAB medications post-implant. The overall lead revision rate was 14% (4/28) and 3 devices required removal. SNM is an efficacious treatment option for PD patients with a high percentage of patients having improvement in their urinary symptoms.

LCRR Compliance Involves More Than Lead Service Lines

LCRR Compliance Involves More Than Lead Service Lines

Halifax Water's Lead Service Line Replacement Program Gets the Lead Out

Key TakeawaysHalifax, N.S., has been addressing concerns over lead in its water supply since the 1940s. Today, there are about 3,500 private‐side lead service lines (LSLs) in Halifax Water's service area.Research findings have guided Halifax Water in examining and modifying its approaches to LSL replacement, corrosion control, and sampling protocol.Motivated by recommended US Lead and Copper Rule revisions, Halifax Water updated its lead removal program and later its Get the Lead Out program to be even more comprehensive.

Power of Partnerships: Public Health and Water Systems Protect Community Health Together

Key TakeawaysWater systems can positively influence public well‐being by teaming up with health agencies.Two case studies are presented that show how this collaborative work can happen at a local level.In the United States, the Lead and Copper Rule Revisions open the way for stronger communications across the water and public health sectors.

His-Purkinje Conduction System Pacing inAtrioventricular Block: New Insights Into Site of Conduction Block.

This study aims to assess the safety and feasibility of achieving His-Purkinje conduction system pacing (HPCSP) in consecutive patients with atrioventricular block (AVB) and to describe the site of conduction block in patients with infranodal AVB. HPCSP has evolved as the preferred form of physiologic pacing. Left bundle branch area pacing (LBBAP) has emerged as an effective alternative to His bundle pacing (HBP). Consecutive patients with AVB referred for pacemaker implantation were included in the study. HBP or LBBAP was attempted in all patients. Site of conduction block was identified as nodal or infranodal (intra-Hisian or infra-Hisian) AVB. HPCSP was attempted in 333 consecutive patients with AVB and was successful in 322 (97%) patients. HBP was achieved in 140 patients, LBBAP in 179 patients, and both in 3 patients. Site of conduction block was nodal in 55% and infranodal in 45% (intra-Hisian 89%; infra-Hisian 4%; indeterminate 7%). QRS duration at baseline was 111 ± 27 versus 129 ± 31 (P< 0.001) compared to 126 ± 24 vs 125 ± 21 milliseconds (P=0.75) during HBP and LBBAP, respectively. HBP thresholds at implant were higher compared to LBBAP (1.2 ± 0.7V at 0.9 milliseconds vs 0.6 ± 0.3V at 0.5 milliseconds; P< 0.001) but remained stable during follow-up. Lead revision was required in 3% and 2% of patients with HBP and LBBAP, respectively. HPCSP pacing was successfully performed in 97% of unselected patients with AVB irrespective of the site of conduction block. True infra-Hisian block (distal His-Purkinje conduction disease) is rare. HBP and LBBAP were complementary in achieving stable and low capture thresholds.

Can permanent His Bundle Pacing be safely started by operators new to this technique? Data from a multicenter registry

Right ventricular pacing (RVP) induces ventricular asynchrony in patients with normal QRS and increases the risk of heart failure and atrial fibrillation on long-term. His bundle pacing (HBP) is a physiological alternative to RVP, and could overcome its drawbacks. Recent studies assessed feasibility and safety of HBP in expert centers with a vast experience of this technique. These results may not apply to less experienced centers. We aim to evaluate feasibility and safety of permanent HBP performed by physicians who are new to this technique. We included all patients who underwent pacemaker implantation with attempt of HBP in 3 hospitals between September 2017 and January 2020. Indication for HBP was left to operators’ discretion. All the operators were new for HBP. His Bundle (HB) electrical parameters were recorded at implant, 3- and 12-month follow-up. HBP was successful in 141 of 170 patients (82.9%); selective HBP was obtained in 96 patients and nonselective HBP in 45. The mean procedure and fluoroscopy durations were 67.0 ± 28.8 min, and 7.3 ± 8.1 min (3.1 ± 4.1 Gy.cm 2 ), respectively. The mean HB paced QRS duration was 106 ± 18 ms. The mean HB capture threshold was 1.29 ± 0.77 V and did not increase at 3- and 12-month follow-up. Ventricular lead revision was required in 5 patients. Our results showed a rapid technical learning allowing a high procedure success rate (89.8%) after 15 procedures ( Fig. 1 ). HBP performed by operators new to this technique appeared feasible and safe. This should encourage HBP to be performed in patients expected to experience high RVP burden.

Using the Lead and Copper Rule Revisions Five-Sample Approach to Identify Schools with Increased Lead in Drinking Water Risks

Despite public concern, the risk of lead exposure from schools remains poorly understood. The Lead and Copper Rule Revisions (LCRR) include, for the first time, a five-sample lead testing requirement for all elementary schools. However, the United States Environmental Protection Agency does not define school-wide lead risk or provide clear guidance on how results should be interpreted. Using the Massachusetts Lead in School Drinking Water Database, we explored the application of the LCRR sampling approach and provide insight into the magnitude and distribution of lead in water in Massachusetts public schools. We observed that 12% of fixtures had first draw lead >15 ppb and 3% after a 30 s flushing. Approximately 90% of fixtures with lead >15 ppb were clustered in 34% of schools. We determined a school-wide 90th percentile of 10 ppb closely approximated this clustering of problem fixtures and were able to identify schools with problem fixtures using the five-sample results with a confidence >90%. Fixtures releasing lead >1 ppb occurred in >90% of schools and represented 58% of first draws and 33% of 30-s flushed samples. Overall, our study provides an approach to classify a school’s lead risk, which could help water utilities and schools prioritizing testing and remediation efforts.

Implantable cardioverter-defibrillators with end stage renal disease: Nationwide inpatient sample database results.

When compared to patients with normal renal function, patients with chronic kidney disease develop higher in-hospital complications post implantable cardioverter-defibrillator (ICD) therapy. However, real world data on in-hospital complications post ICD therapy in patients with end stage renal disease (ESRD) is limited. In this study, we aim to explore the procedure-related complications of ICD therapy in patients with ESRD. Using the nationwide inpatient sample (NIS) database, we conducted a retrospective analysis on ESRD patients who underwent inpatient ICD placement from 2010 to 2016. Using 1:2 propensity score matching, we compared ESRD patients to those with normal renal function. Outcomes of interest were postoperative hemorrhage and hematoma formation, blood transfusion, pericardial complications, mechanical complications requiring lead revision, vascular injury, in-hospital mortality, and length of stay. Our sample included 40,075 cases with subsequent propensity score matching between ESRD and normal renal function. Comparatively, patients with ESRD had higher odds of postoperative hemorrhage (Odds ratio [OR]=1.67, 95% confidence interval [CI] 1.4-1.99, p=<.0001), blood transfusion (OR, 3.88; CI 3.29-4.56; p=<.0001), mechanical complications requiring lead revision (OR, 1.24; CI 1.01-1.51; p=.035), vascular injury (OR, 2.02; CI 1.27-3.24; p=.0027), in-hospital mortality (OR, 4.56; CI 3.08-6.76; p=<.0001), and longer hospitalization (11 vs. 7 days, p=<.0001), but without significant difference in pericardial complications (OR, 1.9; CI 0.92-1.54; p=<.18). In this large contemporary cohort, patients with ESRD undergoing inpatient ICD therapy are at higher risk of developing postprocedural complications including hemorrhage and hematoma, blood transfusion, mechanical complications requiring lead revision, and in hospital mortality, without increased risk of pericardial complications.

Transvenous lead implantation via the accessory hemiazygos vein in superior vena cava occlusion.

Occlusion of the superior vena cava (SVCO) hinders pacemaker and defibrillator lead delivery. Central venous stenosis or occlusion due to pacemaker or defibrillator leads is relatively common at the time of lead revision or device upgrade; however, complete occlusion occurs in less than 10%.1,2 Multiple implanted leads is associated with increased risk of developing SVCO.3 The presence of a persistent left superior vena cava (SVC) also complicates lead delivery and impacts lead stability; however, lead delivery is often still feasible.

Prospective long-term follow-up of silicone-polyurethane–insulated implantable cardioverter-defibrillator leads

BackgroundSt Jude Medical (now Abbott) Optim-insulated implantable cardioverter-defibrillator (ICD) leads were expected to overcome problems with insulation abrasion and externalized conductors in earlier models. Long-term follow-up is essential to the evaluation of lead performance.ObjectiveTo determine, in a prospective cohort of Optim-insulated ICD leads, the rates of all-cause mechanical failure and its subtypes (conductor fracture, insulation abrasion, externalized conductors, and other mechanical failures) and electrical dysfunction adjudicated as nonmechanical failure.MethodsAbbott established 3 prospective registries, enrolling 11,155 leads among 10,872 patients beginning in 2006. There was standardized baseline documentation, 6-monthly follow-up, adverse events reporting, and documentation of lead revision or inactivation, study withdrawal, and death or transplant. The Population Health Institute (McMaster University) reviewed database functions, adjudicated all potential mechanical lead failures, and conducted independent data analyses.ResultsDuring a median follow-up of 4.6 years, there were 171 mechanical failures (1.53%, 95.4% freedom from failure by 12 years). There were no significant differences in survival among Durata DF4 and DF1 and Riata ST Optim leads. The year-to-year rate of failure of leads increased over time. There were 69 electrical dysfunctions (0.62%, 98.8% freedom from failure by 12 years) adjudicated as nonmechanical failure.ConclusionDuring follow-up as long as 12 years (median 4.6 years), Optim-insulated leads had low rates of mechanical failure and electrical dysfunction. Independent analyses provide reliable data on the long-term outcomes essential to analyzing ICD lead performance.

Adopting permanent His bundle pacing: learning curves and medium-term outcomes.

This study aims to determine procedural characteristics, acute success rates, and medium-term outcomes of consecutive patients undergoing His bundle pacing (HBP); and learning curves of experienced electrophysiologists adopting HBP. Consecutive HBP patients at three hospitals were recruited. Clinical characteristics, acute procedural details, and medium-term outcomes were extracted from electronic medical records. Two hundred and thirty-three patients [mean age 74.6 ± 10.1 years, 48% female, 68% narrow QRS, 71% normal left ventricular ejection fraction (LVEF), 55.8% atrioventricular block] underwent HBP. Acute procedural success was 81.1% (mean procedural and fluoroscopic times of 105.5 ± 36.5 and 13.8 ± 9.3 min). Broad QRS was associated with lower HBP success (odds ratio 0.39, P = 0.02). Fluoroscopic and procedural times decreased and plateaued after 30-40 cases per operator. Implant HBP threshold was 1.3 ± 0.7 V at 1.0 ± 0.2 ms and R wave was 5.0 ± 3.9 mV. During follow-up, loss of HBP occurred in a further 12.4% and 11.3% of patients experienced a ≥1 V increase in HBP threshold. Five (2.6%) patients required HBP revision for pacing difficulties. About 8.6% of patients had a >50% decrease in R wave but lead revision for sensing issues was not necessary. On an intention to treat basis, 56.7% of patients in whom HBP was attempted had persisting HBP capture and thresholds of <2 V. Physicians adopting HBP should be cognizant of the learning curve and preferentially select non-dependent patients with normal QRS and LVEF, to minimize risk of lead revision. Further rises in HBP threshold may increase battery drain and need for reoperations, important considerations when choosing HBP for cardiac resynchronization therapy.

Sacral nerve stimulator success after filum section for refractory dysfunctional voiding

Filum section (FS) has been used to treat tethered cord syndrome (on MRI or occult) in pediatric patients with refractory dysfunctional voiding (DV). While controversial, some groups have previously reported significant improvement in patients' symptoms after FS, even in the presence of a normal preoperative spinal MRI. Until recently, it was our practice to refer patients with DV to pediatric neurosurgery for evaluation, MRI, and possible FS. We report our experience with sacral nerve stimulator (SNS) placement for pediatric patients with refractory DV after failed FS with the primary outcome being complications and explantations. The secondary outcome being change in quality of life. We retrospectively reviewed all consecutive patients <18 years old who underwent second stage SNS placement after FS at our institution between November 2012 and December 2019. We abstracted rate of 2nd stage implantation, complication, and explantation. We also collected age-appropriate preoperative and postoperative 15-question quality of life questionnaires (PedsQL™). The PedsQL scores ranged 0-100, higher numbers correlating with higher quality of life. A paired t-test was used for statistical analysis. Overall, 23 children proceeded to the second stage SNS due to persistent symptoms following FS. Median age at SNS implantation was 10.3 years (IQR 7.5-11.8 years), and 13 were female (56.5%). There were no intraoperative complications. Median follow-up was 2.8 years (IQR 1.1-3.7 years). One patient had the SNS removed due to a need for MRI, one for resolution of symptoms, and 4 patients underwent lead revision for lead fracture and return of symptoms (17.4%). All 15 patients who completed both preoperative and postoperative PedsQL reported significantly improved overall scores after SNS (Figure). Median scores improved from 61.7 to 86.7 (p<0.0001). Symptom relief in the child with refractory DV using SNS is not new. However, we sought to review our results in those with previous FS for tethered cord syndrome. While our study is limited by its small size, we assessed both surgical and patient-reported outcomes. Our patients' marked improvement in quality of life is similar to that of other reported pediatric SNS cohorts. SNS placement after FS is feasible, safe, and can result in significant improvement in overall quality of life. Given these findings, we have changed our practice to offer SNS in patients with refractory DV with a normal lumbosacral spinal MRI. For those with MRI abnormalities, we seek neurosurgical evaluation for FS (if deemed necessary) prior to considering SNS.

Left bundle branch pacing: 2 year single-centre experience

Abstract Background Left Bundle Branch Pacing (LBBP) ensures a physiologic ventricular activation and shows better electrical parameters compared to His bundle pacing (HBP). A growing body of experience is encouraging a large applicability. Objective To analyse feasibility and technical outcomes of LBBP in the daily clinical practice. Methods During 2019 and 2020, 132 patients (mean age 79±10 years; 72 males) with standard indication for pacing, received the lead deeply intraseptal aiming to pace the left bundle. The indication for pacing were AV block 72 (55%) pts, SND 14 (11%), AF and slow ventricular rate 21 (16%), ablate&amp;pace in 4 (3%); HF in 10 (7.5%), PICM 6 (4%) pts, lead revision in 5 (3.5%). 75% of pts had ischemic cardiopathy; 82% hypertension, 30% diabetes and 21% severe kidney disease. Baseline QRS was 141±38 ms and 68% of pts had bundle branch block. The basal mean EF 49±15%. 91 (69%) of the pts were in sinus rhythm at implant. Criteria for LBBP were: RBB morphology in V1 together with left ventricular activation time (LVAT)&amp;lt;80 ms in V6. Final lead position was always confirmed with injection of 5 ml of dye contrast in left anterior oblique view. Results The lead was successfully implanted in the left bundle in 129 (97,7%) patients. In the remaining 3 patients the cathode only penetrated the septum. In 90 cases LBBP was the first choice, in the remaining 42 patients LBBP was aimed after unsatisfactory HBP (His threshold&amp;gt;2V or paced QRS&amp;gt;140 ms). In 107 cases we utilized the 3830 4Fr lumenless lead; in 25 cases the stylet-driven 6 Fr leads. The LBBP lead was connected to the RV port in the 92 dual-chamber PMs; in the LV port in the 22 three-chamber devices as part of cardiac resynchronization therapy; in the only port in 18 single-chamber PM. Mean fluoroscopy time was 10±6 min including implant of all leads. Electrical parameters were highly favourable (R wave sensing 10,5±5 mV; threshold 0,9±0,2 V@0,5 ms; impedance 829±234 ohm). Paced QRS duration was 114±20 ms (P&amp;lt;0.005). The devices were checked 48 hours after implant and 1 month later. Thereafter were remotely monitored. At the 1-month in clinic interrogation all LB lead showed good performance and QRS morphology and duration like the post implant one (115±21 ms). Mean VP% was 81% and mean AP% 28%. VP ≥90% was detected in 42 (32%) of patients. Chronic AF (AT/AF 100%) in 24 (18%) of patients. In 3 cases the LB lead showed early dislodgement requiring lead revision (1 macroscopic dislodgement and 2 rise in threshold), all of them within 7 days after implant. Conclusion The new technique of pacing the left bundle of the conduction system (LBBP), is safe and feasible in the clinical practice. It is applicable in all pacing indications including heart failure and resynchronization. In our experience lead dislodgement were 2,2% (3/132, all in the first week after implant) whereas paced QRS duration was significantly shortened and ejection fraction remained normal. Funding Acknowledgement Type of funding sources: None.

Antibiotic selection and risk profiles in patients receiving antibacterial cardiovascular implantable electronic device envelopes – a real world sample and analysis

Abstract Background The use of a cardiovascular implantable electronic device (CIED) envelope impregnated with antibiotics provides short-term local antibiotic delivery in the implant pocket and may lower infection risk. Biologic antibacterial (BIO) envelopes, such as the porcine extracellular matrix (ECM) device hydrated with antibiotics, facilitate active remodeling of the pocket into vital, vascularized tissue and provide short-term local antibiotic delivery. Limited clinical data is available on real-world clinician patient selection criteria, antibiotic choices, or clinical outcomes. Purpose To explore antibiotic hydration solution physician choices with respect to patient profiles, and to determine post-implant infection outcomes in patients receiving a CIED BIO envelope. Methods A post-hoc sub-analysis of a multicenter, non-randomized study of 1017 patients receiving a biologic envelope (hydrated with or without antibiotics) during CIED procedures (SECURE Study) assessed antibiotic hydration choices, patient risk profiles, and the type and timing of infection for days 0–90 post procedure. Patient selection and antibiotic hydration choice were at the discretion of the treating physician. Results 850 patients received BIO envelopes, with a mean age of 71.9 years, and 60.5% having ≥2 standard infection risk factors. High power devices accounted for 47.6% and reoperations for 44.0% of the procedures. Antibiotic choice for envelope hydration prior to implantation is described in Table 1 below. Also, antibiotic combinations with gentamicin were used in 18.1% and other antibiotic combinations in 9.2% of patients. Patients receiving gentamicin hydrated BIO envelopes (BIO+G) trended toward fewer pocket infections vs. those without gentamicin (BIO-G) (0.0% vs. 1.6%, p=0.070) but the overall pocket infection rate of 1.2% was not significantly different based upon antibiotic choice. In a multivariate logistic regression model designed to predict the total infection rate, the use of gentamicin was associated with a 3-fold reduction in likelihood of infection, OR 3.0 (1.0–10.0); AUC=0.70. No differences in overall infection rates among patients undergoing lead or pocket revision only procedures (0.0% vs. 0.0%) or other major adverse events were observed based upon antibiotic usage. Conclusions Real world clinical decision-making regarding antibiotic choice for biologic antibacterial envelopes varies among implanting clinicians and influences observed outcomes. The use of biologic antibacterial envelopes hydrated with gentamicin was associated with a lower likelihood of infection within 90 days when compared to biologic envelopes hydrated without gentamicin. Clinical trials to optimize patient selection processes and determine the best antibiotic choice when employing a CIED envelope merit further investigation. Funding Acknowledgement Type of funding sources: Other. Main funding source(s): The work was supported by Aziyo Biologics, Inc. Table 1. BIO Envelope Hydration

Left Bundle Branch Area Pacing: Implant Technique, Definitions, Outcomes, and Complications.

Conduction system pacing (CSP) has emerged during the last few years as the cornerstone of physiological pacing. Two different CSP modalities have been described so far: His bundle pacing (HBP) and left bundle branch area pacing (LBBAP). This review will be focused on the description of LBBAP technique, definitions, outcomes, and complications. Large observational studies have demonstrated the safety and feasibility of LBBAP in different scenarios. LBBAP has been associated with excellent pacing electrical parameters (pacing threshold and R wave sensing) and low complication rates including lead revision < 1%. In patients with cardiac resynchronization therapy (CRT) indication, LBBAP has shown significant improvement of functional class and left ventricular ejection fraction during short-term follow-up. LBBAP is a relatively new CSP modality showing excellent results for patients with conventional bradycardia pacing indications and promising expectations about its potential role for CRT.

A critical opportunity: Detecting and Reducing Lead in Drinking Water at child care facilities

There is no safe level of lead exposure. As exposure from point sources like lead paint have decreased, non-point sources such as drinking water have become a greater proportional source of total lead exposure. Even at low levels, lead exposure is shown to harm children, contributing to impaired development as well as learning and behavioral issues. This paper summarizes the key results of an Environmental Defense Fund (EDF) pilot study conducted at 11 child care facilities in 4 US states to evaluate approaches to testing and remediating lead in water at child care facilities.Over 75% of first draw samples contained lead levels under the 1 μg/L level recommended by the American Academy of Pediatrics (AAP). However, 10 of 11 child care facilities produced at least one sample above 1 μg/L. Fixture flushing, aerator cleaning, and fixture replacement were evaluated as remediation strategies. Fixture replacement was effective when initial lead was above 5 μg/L. Aerator cleaning did not have a measurable effect on lead levels for most fixtures but unexpectedly significantly increased lead levels in approximately 30% of fixtures. The 2021 Lead and Copper Rule (LCR) revision was applied to study data to determine whether updates would flag cases of low-level lead in child care settings and was found insufficient to prompt mitigation unless high lead was present at most taps.

Safety and feasibility of conduction system pacing in patients with congenital heart disease.

Conduction system pacing (CSP) has emerged as an ideal physiologic pacing strategy for patients with permanent pacing indications. We sought to evaluate the safety and feasibility of CSP in a consecutive series of unselected patients with congenital heart disease (CHD). Consecutive patients with CHD in which CSP was attempted were included. Safety and feasibility, implant tools and electrical parameters at implant and at follow-up were evaluated. A total of 20 patients were included (10 with a previous device). A total of 10 patients had complex forms of CHD, 9 moderate defects and 1 a simple defect. CSP was achieved in 75% of cases (10 His bundle pacing, 5 left bundle branch pacing) with left ventricular septal pacing in the remaining 5 patients. Procedure times and fluoroscopy times were prolongued (126 ± 82 min and 27 ± 30 min, respectively). Ventricular lead implant times widely varied ranging from 4 to 115 min, (mean 31 ± 28 min) and the use of multiple delivery sheaths was frequent (50%). The QRS width was reduced from 145 ± 36 ms at baseline to 116 ± 18 ms with CSP. Implant electrical parameters included: CSP pacing threshold 0.95 ± 0.65 V; R wave amplitude 9.2 ± 8.8 mV and pacing impedance 632 ± 183 Ohms, and remained stable at a median follow-up of 478 days (interquartile range: 225-567). Systemic ventricle systolic function and NYHA class (1.50 ± 0.51 vs. 1.10 ± 0.31; p = .008) significantly improved at follow-up. Lead revision was required in one patient at Day 4. Permanent CSP is safe and feasible in patients with CHD although implant technique is complex.

Outcomes of conduction system pacing compared to right ventricular pacing as a primary strategy for treating bradyarrhythmia: systematic review and meta-analysis

BackgroundRight ventricular pacing (RVP) may cause electrical and mechanical desynchrony leading to impaired left ventricular ejection fraction (LVEF). We investigated the outcomes of RVP with His bundle pacing (HBP) and left bundle branch pacing (LBBP) for patients requiring a de novo permanent pacemaker (PPM) for bradyarrhythmia.Methods and resultsSystematic review of randomized clinical trials and observational studies comparing HBP or LBP with RVP for de novo PPM implantation between 01 January 2013 and 17 November 2020 was performed. Random and fixed effects meta-analyses of the effect of pacing technology on outcomes were performed. Study outcomes included all-cause mortality, heart failure hospitalization (HFH), LVEF, QRS duration, lead revision, atrial fibrillation, procedure parameters, and pacing metrics. Overall, 9 studies were included (6 observational, 3 randomised). HBP compared with RVP was associated with decreased HFH (risk ratio [RR] 0.68, 95% confidence interval [CI] 0.49–0.94), preservation of LVEF (mean difference [MD] 0.81, 95% CI − 1.23 to 2.85 vs. − 5.72, 95% CI − 7.64 to -3.79), increased procedure duration (MD 15.17 min, 95% CI 11.30–19.04), and increased lead revisions (RR 5.83, 95% CI 2.17–15.70, p = 0.0005). LBBP compared with RVP was associated with shorter paced QRS durations (MD 5.6 ms, 95% CI − 6.4 to 17.6) vs. (51.0 ms, 95% CI 39.2–62.9) and increased procedure duration (MD 37.78 min, 95% CI 20.04–55.51).ConclusionOf the limited studies published, this meta-analysis found that HBP and LBBP were superior to RVP in maintaining physiological ventricular activation as an initial pacing strategy.

Safety of Lead Repair Compared to Lead Revision for Visible Lead Insulation Defects in Patients With Cardiac Implantable Electronic Devices

BackgroundCardiac implantable electronic devices deliver life-sustaining therapy and may be prone to hardware degeneration over time. Functioning transvenous endocardial leads with visible insulation breaks are amenable to lead revision (LRV) or lead repair (LRP), with medical adhesive. The latter is a less invasive and more cost-effective strategy. However, data are sparse on the overall safety of such an approach. MethodsThis is a retrospective cohort study of patients with lead insulation defects managed by either LRV or LRP with medical adhesive. The data analyzed were from January 2010 to January 2021. All-cause mortality, and both early and late complications, was ascertained for all cases. ResultsA total of 57 cases were identified, with a mean age (standard deviation) of 75 (±11.8) years; 18 (31.6%) were women. A total of 35 patients (62.5%) underwent LRV for an insulation defect, and 21 (37.5%) underwent LRP. There was no statistical difference in the rate of early and late complications between the 2 groups over a mean follow-up period of 1.15 (±0.78) years [3 (8%)] LRV vs 1 (5%) LRP, P = 0.88). One death was identified in each group, unrelated to either the device or a device-related procedure. There was no association between device type and the likelihood of LRP vs LRV as an attempted strategy (χ2 = 2.25, P = 0.53). ConclusionsThe results of this study suggest that the use of a lead-repair strategy, with silicone adhesive glue and an anchoring sleeve, is not associated with an increased rate of early or late complications, compared with lead revision in the management of visible lead insulation defects with stable lead function.