Procedural and long-term outcomes of tunneled transvenous leads.

BACKGROUND: Lead-related venous stenosis and occlusion can complicate the insertion or replacement of transvenous leads in patients with cardiac implantable electronic devices (CIEDs). A possible solution is to tunnel the lead from the contralateral vasculature to the ipsilateral generator. Procedural complications and long-term outcomes remain unclear with this technique. OBJECTIVE: We sought to assess outcomes of tunneled transvenous leads. METHODS: We retrospectively identified all patients who underwent transvenous CIED lead tunneling to a contralateral pocket at our institution between 2014 and 2024. Clinical characteristics, indications for lead implantation, postoperative complications, and long-term outcomes were collected. RESULTS: We identified that 27 patients underwent transvenous lead tunneling at our institution. Most patients were men (20, 74%) with a mean age of 68.8 ± 18.3 years. Most patients had nonischemic cardiomyopathy (16, 59%) with a mean ejection fraction of 29.3% ± 11.3%. The tunneled leads were coronary sinus leads (20, 74%), followed by defibrillator leads (5, 18.5%) and right ventricular pacing leads (2, 7.4%). Implantation procedures were primarily for device upgrade (18), lead revisions (8), or de novo lead placement (1). No postoperative complications were seen. Patients were followed for a mean of 2.2 ± 1.4 years. One tunneled defibrillator lead (3.7%) had low shock impedance 3 years after implantation, which was monitored and did not require an intervention. CONCLUSION: In patients with ipsilateral venous occlusion, contralateral lead tunneling appears to be an effective and safe approach to manage patients with CIEDs and occluded ipsilateral subclavian veins.

A systematic review and meta-analysis for the efficacy of transcranial direct current stimulation (tDCS) in OCD treatment: A non-pharmacological approach to clinical interventions.

Obsessive-compulsive disorder (OCD) is a prevalent mental condition characterized by recurrent, unwanted thoughts (obsessions) and repetitive behaviors (compulsions), significantly disrupting daily functioning and social interactions. Transcranial direct current stimulation (tDCS) presents a promising non-invasive treatment modality aimed at alleviating symptoms. However, the evidence regarding its effectiveness remains inconclusive. This study seeks to address this gap by conducting a systematic review and meta-analysis of clinical trials, offering improved guidance for clinical intervention. A comprehensive search strategy was implemented across multiple databases, including PubMed, Cochrane CENTRAL, Embase, Scopus, and Web of Science. This search focused strictly on randomized controlled trials (RCTs) involving 147 patients. These trials evaluated the efficacy of tDCS in OCD patients. Subsequent data extraction, risk of bias assessment, and statistical analysis using Review Manager software revealed the potential efficacy of tDCS in reducing OCD symptoms. The meta-analysis not only fails to demonstrate significant superiority of active tDCS over sham tDCS but also suggests that sham tDCS may be more effective than active tDCS in reducing OCD symptoms. This finding diminishes the promise of tDCS as an effective treatment for OCD. Larger trials are warranted to further elucidate these findings.

Sex-based outcomes of subcutaneous implantable cardioverter-defibrillator and impact of surgical technique.

BACKGROUND: Because of differences in chest wall anatomy, female patients may have higher rates of subcutaneous implantable cardioverter-defibrillator (S-ICD) pocket-related complications. OBJECTIVE: We sought to evaluate sex-based outcomes after S-ICD implantation. METHODS: Patients implanted with an S-ICD at Emory Healthcare between 2010 and 2023 were included in the analysis. Patients' clinical characteristics and post-S-ICD implantation complications were collected. RESULTS: There were 429 male patients (68%) and 199 female patients (32%) observed for a median duration of 2.3 years (0.6-4.4 years). Male and female patients had comparable rates of diabetes (28%), end-stage renal disease (29.5%), ejection fraction (30.2% ± 13.4%), and body mass index (29.1 ± 6.6 kg/m2). There was no statistical difference in the incidence of shocks between men and women (26.3% vs 20.1%; P = .09), including appropriate shocks (14.7% vs 12%; P = .98) and inappropriate shocks (11.7% vs 9.5%; P = .98). Pocket-related complications occurred in 21 patients; these included pocket infection (n = 12), wound dehiscence (n = 7), and hematoma requiring drainage (n = 2). Female patients had a significantly higher pocket-related complication rate compared with male patients (7.2% vs 2.5%; P = .016). In controlling for age, body mass index, diabetes, and end-stage renal disease, female patients had higher odds of pocket-related complications compared with male patients (odds ratio, 3.15; 95% confidence interval, 1.27-7.75). Pocket-related complications decreased after 2018 compared with before 2018 (6% vs 2.6%, P = .052), mainly driven by reduction in complications in women (12.3% vs 3.2%; P = .034) but not in men (2.8% vs 2.4%; P = 1). CONCLUSION: In this cohort of S-ICD patients, women had a higher rate of post-S-ICD pocket-related complications that could be explained by sex-based differences in anatomy.

Accurate detection of lead malfunction from ECG-derived bipolar pacing stimulus amplitude.

BACKGROUND: One common mode of lead failure is insulation breach, which may result in myopotential noise and device malfunction. "Pseudo-unipolarization" of bipolar pacing stimuli, as observed from a routine 12-lead electrocardiogram (ECG) due to stimulus current leak, has been observed with insulation breaches. OBJECTIVE: We sought to characterize this electrocardiographic finding to detect this type of lead malfunction. METHODS: A total of 138 transvenous leads were analyzed, including 88 with known malfunction and 50 normal leads. The amplitude of a bipolar pacing stimulus on the ECG was recorded and compared with a control data set of newly implanted leads with bipolar stimuli normalized for output. RESULTS: The malfunction group consisted of 61% right atrium and 39% right ventricle leads with mean pacing output of 2.74 V at 0.5 ms. There was a significant difference in ECG bipolar stimulus amplitudes at time of identification of failure (7.89 ± 7.56 mm/V; P < .001) compared with those of normal leads (0.86 ± 0.41 mm/V). Receiver operating characteristic curve for the prediction of lead malfunction based on absolute ECG amplitude displayed an area under the curve of 0.93 (95% CI, 0.891-0.969). When normalized for programmed stimulus output, a cutoff of 5 mm/V demonstrated a sensitivity of 91% and a specificity of 92% (area under the curve, 0.967; 95% CI, 0.938-0.996). CONCLUSION: The maximum amplitude of a bipolar pacing stimulus on the ECG is significantly lower in normal functioning leads compared with those with known malfunction. This simply derived variable demonstrated good accuracy at identifying lead failure due to insulation breach.

Evaluation of the in vivo chemical reactivity of a novel copolymer insulation on cardiac leads in a single-center study.

BACKGROUND: Human in vivo data on the chemical stability of different transvenous lead materials, particularly OptimTM leads, are lacking. OBJECTIVES: The purpose of this study was to determine the chemical reactivity of insulation materials by analyzing the molar mass of extracted pacing and defibrillator leads METHODS: We collected extracted leads at Emory University Hospitals and sent the leads with thermoplastic outer insulation material for molar mass analysis, a material characteristic that informs biostability. Leads were separated based on the chemical identity of the outer insulation material, and the molar mass was measured by an independent party. The extent of chemical reaction was compared across leads having different materials: poly(ether)urethane 55D, poly(ether)urethane 80A, and Optim. RESULTS: A total of 70 leads were extracted. The subset of extracted leads having outer insulation materials composed of PEU or Optim were analyzed for molar mass, where implant times ranged from 0.12 to 16.26 years. The rate of chemical degradation was compared by plotting the extent of reaction [Mn(t = 0)/Mn(t)] as a function of implant time. The Optim molar mass decreased to 40% of its initial value at 10 years of implant. No change in the molar mass of the PEU insulations could be resolved over the same 10-year implant time. CONCLUSION: Because the molar mass of a polymer is directly related to its mechanical integrity, the observed decrease in molar mass of Optim likely translates into premature insulation defects and is consistent with the observed increased rate of electrical malfunction/noise in this subset of cardiac leads.

Outcomes of tricuspid regurgitation after lead extraction.

INTRODUCTION: Transvenous leads have been implicated in tricuspid valve (TV) dysfunction, but limited data are available regarding the effect of extracting leads across the TV on valve regurgitation. The aim of this study is to quantify tricuspid regurgitation (TR) before and after lead extraction and identify predictors of worsening TR. METHODS: We studied 321 patients who had echocardiographic data before and after lead extraction. TR was graded on a scale (0 = none/trivial, 1 = mild, 2 = moderate, 3 = severe). A change of >1 grade following extraction was considered significant. RESULTS: A total of 321 patients underwent extraction of a total of 338 leads across the TV (1.05 ± 0.31 leads across the TV per patient). There was no significant difference on average TR grade pre- and postextraction (1.18 ± 0.91 vs. 1.15 ± 0.87; p = 0.79). TR severity increased after extraction in 84 patients, but was classified as significantly worse (i.e., >1 grade change in severity) in only 8 patients (2.5%). Use of laser lead extraction was associated with a higher rate of worsening TR postextraction (44.0% vs. 31.6%, p = 0.04). CONCLUSION: In our single-center analysis, extraction of leads across the TV did not significantly affect the extent of TR in most patients. Laser lead extraction was associated with a higher rate of worsening TR after extraction.

Optimal Medical Therapy for Stable Ischemic Heart Disease: Focus on Anti-anginal Therapy.

Chronic coronary disease (CCD) is a major cause of morbidity and mortality worldwide. The most common symptom of CCD is exertional angina pectoris, a discomfort in the chest that commonly occurs during activities of daily life. Patients are dismayed by recurring episodes of angina and seek medical help in preventing or minimizing episodes. Angina occurs when the coronary arteries are unable to supply sufficient blood flow to the cardiac muscle to meet the metabolic needs of the left ventricular myocardium. While lifestyle changes and aggressive risk factor modification play a critical role in the management of CCD, management of angina usually requires pharmacologic therapy. Medications such as beta-blockers, calcium channel blockers, nitrates, ranolazine, and others ultimately work to improve the mismatch between myocardial blood flow and metabolic demand. This manuscript briefly describes the pathophysiologic basis for symptoms of angina, and how currently available anti-anginal therapies contribute to preventing or minimize the occurrence of angina.

Multi-proteomic Biomarker Risk Scores for Predicting Risk and Guiding Therapy in Patients with Coronary Artery Disease.

PURPOSE OF REVIEW: Patients with established coronary artery disease (CAD) are at high residual risk for adverse events, despite guideline-based treatments. Herein, we aimed to determine whether risk scores based on multiple circulating biomarkers that represent activation of various pathophysiologically important pathways involved in atherosclerosis and myocardial dysfunction help identify those at greatest residual risk. RECENT FINDINGS: Numerous circulating proteins, representing dysregulation of the pathways involved in the development and stability of coronary and myocardial diseases, have been identified. When aggregated together, biomarker risk scores (BRS) more accurately stratify patients with established CAD that may help target interventions in those individuals who are at elevated risk. Moreover, intensification of guideline-based therapies has been associated with parallel improvements in both BRS and outcomes, indicating that these risk scores may be employed clinically to target therapy. Multi-protein BRS are predictive of risk, independent of, and in addition to traditional risk factor assessments in patients with CAD. Those with elevated risk may benefit from optimization of therapies, and improvements in the BRS will identify those with improved outcomes.

Long-term performance of single-connector (DF4) implantable defibrillator leads.

AIMS: Single-connector (DF4) defibrillator leads have become the predominantly implanted transvenous implantable cardioverter-defibrillator lead. However, data on their long-term performance are derived predominantly from manufacturer product performance reports. METHODS AND RESULTS: We reviewed medical records in 5289 patients with DF4 leads between 2011 and 2023 to determine the frequency of lead-related abnormalities. We defined malfunction as any single or combination of electrical abnormalities requiring revision including a sudden increase (≥2×) in stimulation threshold, a discrete jump in high-voltage impedance, or sensing of non-physiologic intervals or noise. We documented time to failure, predictors of failure, and management strategies. Mean follow-up after implant was 4.15 ± 3.6 years (median = 3.63), with 37% of leads followed for >5 years. A total of 80 (1.5%) leads demonstrated electrical abnormalities requiring revision with an average time to failure of 4 ± 2.8 years (median = 3.5). Of the leads that malfunctioned, 62/80 (78%) were extracted and replaced with a new lead and in the other 18 cases, malfunctioned DF4 leads were abandoned, and a new lead implanted. In multivariable models, younger age at implant (OR 1.03 per year; P < 0.001) and the presence of Abbott/St. Jude leads increased the risk of malfunction. CONCLUSION: DF4 defibrillator leads demonstrate excellent longevity with >98.3% of leads followed for at least 5 years still functioning normally. Younger age at implant and lead manufacturer are associated with an increased risk of DF4 lead malfunction. The differences in lead survival between manufacturers require further investigation.

Prospective validation of a risk score to predict pacemaker implantation after transcatheter aortic valve replacement.

INTRODUCTION: The need for pacemaker is a common complication after transcatheter aortic valve replacement (TAVR). We previously described the Emory Risk Score (ERS) to predict the need for new pacemaker implant (PPM) after TAVR. Metrics included in the score are a history of syncope, pre-existing RBBB, QRS duration ≥140 ms, and prosthesis oversizing ≥16%. To prospectively validate the previously described risk score. METHODS: We prospectively evaluated all patients without pre-existing pacemakers, ICD, or pre-existing indications for pacing undergoing TAVR with the Edwards SAPIEN 3 prosthesis at our institution from March 2019 to December 2020 (n = 661). Patients were scored prospectively; however, results were blinded from clinical decision-making. The primary endpoint was PPM at 30 days after TAVR. Performance of the ERS was evaluated using logistic regression, a calibration curve to prior performance, and receiver operating characteristic (ROC) analysis. RESULTS: A total of 48 patients (7.3%) had PPM after TAVR. A higher ERS predicted an increased likelihood of PPM (OR 2.61, 95% CI: 2.05-3.25 per point, p < 0.001). There was good correlation between observed and expected values on the calibration curve (slope = 1.04, calibration at large = 0.001). The area under the ROC curve was 0.81 (95% CI [0.74-0.88], p < 0.001). CONCLUSIONS: The ERS prospectively predicted the need for PPM in a serial, real-world cohort of patients undergoing TAVR with a balloon-expandable prosthesis, confirming findings previously described in retrospective cohorts. Notably, the prospective performance of the score was comparable with that of the initial cohorts. The risk score could serve as a framework for preprocedural risk stratification for PPM after TAVR.

Impact of Median Sternotomy on Safety and Efficacy of the Subcutaneous Implantable Cardioverter Defibrillator.

BACKGROUND: Subcutaneous implantable cardioverter defibrillators (S-ICDs) are an attractive alternative to transvenous ICDs among those not requiring pacing. However, the risks of damage to the S-ICD electrode during sternotomy and adverse interactions with sternal wires remain unclear. We sought to determine the rates of damage to the S-ICD lead during sternotomy, inappropriate shocks from electrical noise due to interaction with sternal wires, and failure to terminate spontaneous or induced ventricular arrhythmias. METHODS: Retrospective, multicenter study of patients undergoing sternotomy before or after S-ICD implantation. Clinical, procedural, and device-related data were collected by each center and analyzed by the coordinating center. These data were compared with a historical control cohort of nonsternotomy patients. RESULTS: Of 196 identified patients (52±16 years, 47 women), 166 underwent S-ICD implantation after sternotomy and 30 sternotomy after S-ICD. There was no damage to any lead among those who underwent sternotomy after S-ICD. Defibrillation threshold testing was performed in 63% at implant, with 91% first shock success. During a median follow-up of 29 months (range, 1-188), S-ICD first shocks successfully terminated spontaneous ventricular arrhythmias in 31 of 32 patients (97%). Inappropriate shocks occurred in 22 patients, most commonly related to T wave oversensing (n=14). Compared with the nonsternotomy controls, there were no differences in rates of first shock success for induced or spontaneous arrhythmias or rate of inappropriate shocks. CONCLUSIONS: Sternotomy before or after S-ICD does not confer additional risk relative to a historical control group without sternotomy.

The Feasibility and Safety of Flecainide Use Among Patients With Varying Degrees of Coronary Disease.

BACKGROUND: Class IC antiarrhythmic agents are effective for treating atrial tachyarrhythmias, but their use is restricted in patients with coronary artery disease (CAD). Data on the safety of the use of IC agents in patients with CAD in the absence of recent acute coronary syndromes are lacking. OBJECTIVES: This study sought to evaluate the safety and feasibility of treatment with IC agents in patients with varying degrees of CAD in a large serial, real-world cohort. METHODS: We retrospectively identified all patients at our institution from January 2005 to February 2021 on a IC agent (n = 3,445) and those on sotalol or dofetilide (n = 2,216) as controls, excluding those with a prior history of ventricular tachycardia, implantable cardioverter-defibrillator placement, or nonrevascularized myocardial infarction. Baseline clinical characteristics included degree of CAD (categorized as none, nonobstructive, or obstructive), other comorbid illness, and medication use. Clinical outcomes, including survival, were ascertained. We performed Cox regression analysis to evaluate the effect of IC use on event-free survival across varying degrees of CAD. RESULTS: After adjustment for baseline characteristics, there was an independent association between IC use and improved mortality. However, there was an interaction between IC use and degree of CAD (compared to sotalol) demonstrating poorer event-free survival among those with obstructive coronary disease (HR: 3.80; 95% CI: 1.67-8.67; P = 0.002). CONCLUSIONS: Among select patients with nonobstructive CAD and without a history of ventricular tachycardia, IC agents are not associated with increased mortality. Therefore, these agents may be an option for some patients in whom they are frequently restricted. Further prospective studies are warranted.

The life and death of living systematic reviews: a methodological survey.

OBJECTIVES: The objectives of this study are to describe the characteristics of living systematic reviews (LSRs) and to understand their life cycles. STUDY DESIGN AND SETTING: We conducted a comprehensive search up to April 2021 then selected articles and abstracted data in duplicate and independently. We undertook descriptive analyses and calculated delay in version update and delay since the last published version. RESULTS: We included 76 eligible LSRs with a total of 279 eligible versions. The majority of LSRs was from the clinical field (70%), was COVID-19 related (63%), and had a funding source specified (62%). The median number of versions per LSR was 2 (interquartile range (IQR) 1-4; range 1-19). The median and IQR for the ratio of the actual period of update to the planned period of update was 1.12 (0.81; 1.71). Out of all reviews with a 'planned period of update' and at least one update (N = 19), eight LSRs (42%) had a period since last published version greater than 3 times the planned period of update. No LSR included a 'retirement notice' in their latest published version. CONCLUSION: While most LSR complied with the planned period of producing updates, a substantive proportion lagged since their last update.

A Case of Concurrent Mpox and Chlamydial Proctitis in a Patient With HIV.

The monkeypox (mpox) outbreak that began in May 2022 spread globally with a wide range of presentations. Mpox proctitis has been recognized as one of the severe forms of the virus during this outbreak. We present the case of a 33-year-old male with well-controlled HIV engaging in receptive anal intercourse presented with profuse rectal bleeding, tenesmus, and anal pain in July 2022. His symptoms persisted despite treatment for his rectal chlamydia with doxycycline. Rectal imaging with computed tomography demonstrated impressive inflammation. Contrast-enhanced images highlighted rectal wall thickening and submucosal edema. Diffuse lymphadenopathy of the anorectal region was also clearly seen. He received symptomatic treatment with tecovirimat resulting in the resolution of his symptoms and complaints. Subsequent rectal imaging displayed improvement and decreased inflammation. A better understanding of various presentations, imaging characteristics, and management is necessary to curb further dissemination.

Leadless Pacing: Where We Currently Stand and What the Future Holds.

PURPOSE OF REVIEW: Leadless pacemakers (LPs) are emerging as alternative cardiac implantable devices for the treatment of bradyarrhythmia. This article aims to review the data behind the safety and efficacy of these devices while highlighting their pros and cons. RECENT FINDINGS: Prospective non-randomized studies and registries have found that LPs are associated with lower rate of device-related complications mainly driven by lower need for lead-related interventions as compared to traditional pacemakers. On the other hand, cardiac perforation appears to occur more frequently with LPs. LPs are associated with lower rate of device-related complications as compared to the traditional pacemakers. However, the rate of pericardial effusion is higher and is more severe. As we transition to multi-chamber LPs, it is important to ensure the safety and efficacy of these devices.

The Beirut Port Explosion Injuries and Lessons Learned: Results of the Beirut Blast Assessment for Surgical Services (BASS) Multicenter Study.

OBJECTIVE: This multicenter study aims to describe the injury patterns, emergency management and outcomes of the blast victims, recognize the gaps in hospital disaster preparedness, and identify lessons to be learned. SUMMARY BACKGROUND DATA: On August 4th, 2020, the city of Beirut, Lebanon suffered the largest urban explosion since Hiroshima and Nagasaki, resulting in hundreds of deaths and thousands of injuries. METHODS: All injured patients admitted to four of the largest Beirut hospitals within 72 hours of the blast, including those who died on arrival or in the emergency department (ED), were included. Medical records were systematically reviewed for: patient demographics and comorbidities; injury severity and characteristics; prehospital, ED, operative, and inpatient interventions; and outcomes at hospital discharge. Lessons learned are also shared. RESULTS: An estimated total of 1818 patients were included, of which 30 died on arrival or in the ED and 315 were admitted to the hospital. Among admitted patients, the mean age was 44.7 years (range: 1 week-93 years), 44.4% were female, and the median injury severity score (ISS) was 10 (5, 17). ISS was inversely related to the distance from the blast epicenter (r = --0.18, P = 0.035). Most injuries involved the upper extremities (53.7%), face (42.2%), and head (40.3%). Mildly injured (ISS <9) patients overwhelmed the ED in the first 2 hours; from hour 2 to hour 8 post-injury, the number of moderately, severely, and profoundly injured patients increased by 127%, 25% and 17%, respectively. A total of 475 operative procedures were performed in 239 patients, most commonly soft tissue debridement or repair (119 patients, 49.8%), limb fracture fixation (107, 44.8%), and tendon repair (56, 23.4%). A total of 11 patients (3.5%) died during the hospitalization, 56 (17.8%) developed at least 1 complication, and 51 (16.2%) were discharged with documented long-term disability. Main lessons learned included: the importance of having key hospital functions (eg, laboratory, operating room) underground; the nonadaptability of electronic medical records to disasters; the ED overwhelming with mild injuries, delay in arrival of the severely injured; and the need for realistic disaster drills. CONCLUSIONS: We, therefore, describe the injury patterns, emergency flow and trauma outcome of patients injured in the Beirut port explosion. The clinical and system-level lessons learned can help prepare for the next disaster.