Sex, Race, and Socioeconomic Disparities in the Utilization of Transvenous Lead Removal for Patients Hospitalized With Cardiac Implantable Electronic Device Infections in the United States
ABSTRACT Background Transvenous lead removal (TLR) is a Class I indication for patients with cardiac implantable electronic device (CIED) infections. However, disparities in the utilization of TLR have not been fully explored, particularly concerning demographic and socioeconomic factors. Objectives This study aims to examine whether disparities exist among patients hospitalized for CIED infections with respect to the utilization of TLR, focusing on sex, race, and income characteristics. Methods We utilized the 2019 National Inpatient Sample (NIS) to assess patients hospitalized with CIED infections and identify those who underwent TLR. Multiple logistic regression was used to examine risk factors for TLR utilization, including age, sex, race/ethnicity, and socioeconomic characteristics. Results A total of 56 709 patients were hospitalized for CIED infection in the United States in 2019, of which 9867 (17.4%) underwent TLR. On an adjusted analysis, females and Black patients were found to have lower odds of undergoing TLR compared to males and White patients (OR: 0.62; 95% CI: 0.59–0.78; p < 0.01; and OR: 0.47; 95% CI: 0.39–0.57; p < 0.01, respectively). Hispanic patients also had reduced odds of TLR (OR: 0.73; 95% CI: 0.58–0.93; p = 0.01). No significant associations were observed between income or insurance status and the likelihood of receiving TLR after adjustment. Conclusions This study identified significant disparities in the utilization of TLR among patients hospitalized for CIED infections. Female, Black, and Hispanic patients were significantly less likely to receive TLR.
Cardiac function after catheter ablation of ventricular arrhythmias in patients with arrhythmogenic right ventricular cardiomyopathy
Abstract Aims Catheter ablation is commonly performed in patients with arrhythmogenic right ventricular cardiomyopathy (ARVC) for management of ventricular arrhythmias (VAs). The impact of catheter ablation on cardiac function is unknown. The aim is to assess the impact of catheter ablation for VAs on cardiac function in patients with ARVC. Methods and results This retrospective study included consecutive patients with ARVC who underwent catheter ablation for VAs. Cardiac and valvular functions were assessed on pre- and post-procedure cardiac imaging. The severities of tricuspid regurgitation, pulmonic regurgitation, right ventricular (RV) enlargement, and RV systolic dysfunction was graded as absent (=0), mild (=1), mild-moderate (=2), moderate (=3), moderate-severe (=4), or severe (=5). Thirty-four patients were included. Median age at the time of ablation was 49 [inter-quartile range (IQR), 23] years, and 10 (29%) patients were female. After a median follow-up of 1 (IQR, 0) day, 11 (34%) patients had worsening RV function, and 4 (12%) patients had worsening left ventricular ejection fraction (LVEF) >5%. Five (15%) patients required inotropic support. After a median follow-up of 6.5 (IQR, 6.4) months, 20 (59%) patients had repeat transthoracic echocardiograms. Among patients with worsening RV function post-ablation, one-sixth (17%) had improvement in the RV function at follow-up. In contrast, among patients who had an acute drop in LVEF post-ablation, two-thirds (67%) had improvement at follow-up. Conclusion Right ventricular dysfunction following catheter ablation in patients with ARVC is common, affecting one-third of patients. Patients undergoing catheter ablation of VAs should be counselled on the potential negative impact of ablation on cardiac function.
Late Sustained Ventricular Arrhythmias After Left Ventricular Assist Device Implantation: Outcomes and Predictors
ABSTRACTBackgroundThe factors contributing to sustained ventricular arrhythmias (VAs) >30 days after left ventricular assist device (LVAD) implantation are not well‐established.ObjectivesThis study aimed to predict the factors associated with late sustained VAs after LVAD implantation and develop a predictive score to identify patients with an increased risk of late sustained VAs after the procedure.MethodsWe performed a retrospective cohort study on a training cohort of 623 patients and a validation cohort of 157 patients who underwent LVAD implantation at the Mayo Clinic (Rochester, Phoenix, and Jacksonville) from January 1, 2000, to December 30, 2020. Late sustained VAs were defined as ventricular tachycardia (VT) and ventricular fibrillation (VF) occurring >30 days after the LVAD procedure. Detailed chart reviews of the electronic health records within the Mayo Clinic and outside medical records were performed.ResultsA total of 780 patients were included in our study. Late sustained VAs occurred in 30% (n = 232) of the patients. The significant factors associated with late sustained VAs after LVAD were the history of VAs prior to LVAD (34.1% vs. 23.0%, p < 0.01), implantable cardiac defibrillator (ICD) (87.9% vs. 77.6%, p < 0.01) or cardiac resynchronization therapy (CRT) in situ (43.5% vs. 33.6%, p = 0.008), VT ablation prior to LVAD (5.2% vs. 1.8%, p = 0.010), use of amiodarone (49.1% vs. 38.7%, p = 0.007), use of mexiletine (15.5% vs. 5.7%, p < 0.01), and higher left ventricular end‐diastolic diameter (LVEDD) on echocardiography prior to LVAD implantation (71.4 vs. 68.7 mm, p = 0.002). During follow‐up, the patients who developed late sustained VAs after LVAD had lower survival than those who did not (HR = 1.96, 95% CI:156–2.4, p < 0.001). The average time from LVAD to orthotopic heart transplant was longer among late sustained VAs patients (23 vs. 14 months, p < 0.01). The “VIN” risk score was created to identify four risk groups: low (scores 0), intermediate (score 1), high (score 2), and very high (score 3). The rates of late VA's in the training cohort at 1 year were 9.5%, 14%, 18%, and 25% which was almost similar to the risk of late VA's at validation cohort 10%, 12%, 20%, and 63%, respectively.ConclusionsLate sustained VAs occurred in 30% of the patients who received LVAD and were associated with lower survival. The VIN risk score was developed and validated to stratify patients into low, intermediate, high, and very high risk of late sustained VAs.
Abstract 4147722: Clinical impact of new severe tricuspid regurgitation following device lead extraction
Introduction: Tricuspid regurgitation (TR) is a common complication of right ventricle lead extraction (RVLE) in 5 to 10% of cases. This study aims to identify clinical outcomes such as predictors of heart failure hospitalization, need for tricuspid valve intervention, and death among patients with new severe TR after device lead removal (DLR). Methods: Patients who underwent DLR (pacemaker/ICD) between 3/1997 and 3/2024 were identified. Those who had an echocardiogram before and after RVLE with evidence of new severe TR were included. Cox univariable regression controlling for current age was used to assess association with death. Prentice Williams Peterson total time (PWPTT) Cox univariable regression was used to determine the rate of heart failure hospitalization up to three events per subject. Bivariable cox regression was used to control for ejection fraction for ICD and coil removal. Analysis was conducted using Stata IC16. Results: We identified 2,122 people who underwent RVLE, of whom 90 (4.24%) developed new severe TR and were included in the analysis. There were 68 hospitalizations among 38 people at a median of 2 years following lead extraction (IQR 0.57 to 4.5 years). The rate of hospitalization was 11.60 [9.14 to 14.71] per 100 person-years. Removal of an ICD was associated with increased hospitalization (HR 5.48 p<0.001) but not mortality (HR 1.21, p=0.707). Removal of a single coil ICD lead was associated with increased hospitalization rate (HR 3.01, p=0.031) but not mortality (HR =0.51, p=0.380). Removal of dual coil ICD lead was associated with more than a tenfold increase in hospitalization rate (HR 11.55, p=0.001) and four times the mortality rate (HR 4.05, p=0.031) (Figures 1&2). The presence of an abandoned (pacemaker/ICD) lead was associated with increased hospitalization (HR 5.75, p=0.004) and mortality (HR4.95, p=0.034). There was no change in hospitalization rate following tricuspid valve replacement (HR 1.33, p=0.716, n=18). Conclusion: Among people with new severe TR following DLR, the characteristics of the leads are strongly correlated with morbidity and mortality.
Abstract 4134594: More than One Way to Catch a Fish: Micra Extraction Case Series
Description of Cases: Case 1: A 72 year old male with atrial fibrillation (AF) and tachy-brady syndrome underwent Micra implantation. On post-procedure day 2, pacing thresholds were unacceptably elevated. A new Micra device was deployed; subsequently, a microsnare was placed through the Micra delivery catheter and the docking button of the old Micra was successfully snared (Figure A). The old Micra was then captured over the delivery catheter and removed from the body. Case 2: A 76 year old male underwent Micra implantation and AV node ablation for AF with persistent tachycardia. One month later, he presented with heart failure and interval decrease in ejection fraction from 66% to 33%. After biventricular leads were implanted, an Agilis catheter was advanced towards the Micra. The docking button was successfully snared with a gooseneck snare (Figure B), and the Micra was extracted with gentle traction. Case 3: A 76 year old male with complete heart block and longstanding persistent AF received a Micra. Nine months later, he presented with heart failure and interval decrease in ejection fraction from 55% to 25%. A defibrillator lead was implanted but no suitable CS branch was identified. The Aveir retrieval catheter was advanced and the Micra docking button was captured with the triloop snare (Figure C). The protective sleeve was advanced over the Micra and it was successfully removed. Subsequently, a left bundle area lead was placed. Discussion: Although uncommon, extraction of the tined leadless pacemaker (Micra) may be indicated at times. As rates of implantation continue to increase, establishing uniform procedures for extraction becomes increasingly important. These three cases highlight unique options for Micra extraction, and the feasibility of each approach. However, a dedicated tool and protocol would be ideal for patient safety and consistency. No complications occurred with the above cases.
Association between COVID‐19 vaccination and atrial arrhythmias in individuals with cardiac implantable electronic devices
AbstractIntroductionThe impact of mRNA‐based coronavirus disease‐2019 (COVID‐19) vaccines on atrial arrhythmias (AA) and ventricular arrhythmias incidence is unknown.MethodsBIOTRONIK Home Monitoring data and Medicare Claims data were utilized to identify individuals implanted with a cardiac implantable electronic device (CIED) between 2010 and 2020 who received one or more doses of COVID‐19 vaccine in 2021. The burden of AA (%) in the 3 months postvaccination was compared to those noted in the preceding 3 months using the Wilcoxon signed rank test. Sub‐analyses comparing the effects of the influenza vaccine against the COVID‐19 vaccine were also evaluated for individuals who received the influenza vaccine in 2020. A 1:1 propensity score match comparison between COVID‐19 vaccine and non‐vaccinated patients was also performed.ResultsFirst and second doses of the COVID‐19 vaccine were administered to 7757 and 6579 individuals with a CIED (age 76.2 ± 9.0 years, 49% males), respectively. While a small but statistically significant increase in the burden of AA was noted in the 3 months postvaccination compared to the preceding 3 months after the first dose of the COVID‐19 vaccine (0.43 ± 9.04%, p = .028) a similar rise in AA was found following the influenza vaccine and for matched patients who did not receive the COVID‐19 vaccine. No significant difference in device therapies was seen pre‐ and postvaccination.ConclusionsThough we report a small but significant increase in the number of CIED‐detected AAs following vaccination for COVID‐19 over a 3‐month window, we believe these results correlate more with time and the progressive nature of AF rather than the vaccine itself. While these data should not dissuade from the use of these vaccines, increased vigilance and prompt treatment of AF is required for high‐risk groups, specifically males over 70 years of age, following vaccination.
Abstract 18059: Utility of Infarct Edge Homogenization in Controlling Ventricular Tachycardia in Patients With Underlying Ischemic Heart Disease
Introduction: Point source ablation may be effective in eliminating stable ventricular tachycardia (VT), where actual mapping and ablation are possible. Ablating patients with unstable VT is more complicated and may require aggressive intervention. While small linear lesions have been utilized, the actual utility of longer linear homogenization for eliminating ventricular arrhythmias has not been examined. Methods: Therefore, the results of 86 patients undergoing VT ablation at Mayo Clinic were examined. 42 had underlying ischemic heart disease with an EF of 33.5 ± 16.8 had VT with a cycle length of 326 ± 165 ms, and had 2.5± 1.6 episodes of VT in the preceding three months. 32 required shocks for that tachycardia. Results: Of these, 21 patients (16 male, 5 female Age 67±18) underwent detailed linear ablation at the scar margin in an effort to homogenize that region. This was drawn into the infarct scar by decreasing the upper voltage boundary to 2.0. In these patients, 18 showed elimination of clinical VT. In addition, 12 showed a decrease in VT from 10 ± 8.7 episodes down to 2.5 ± 1.2 episodes of actual ventricular arrhythmias. The shock requirement decreased from 8.6 ±4.7 to 1.5 ±2.7. These patients had 7 ± 3.5 different VTs at the time of ablation. These data suggest not only a decrease the occurrence of VT, but an improved control of the arrhythmia as manifested by decreased frequency of episodes and a decrease in shock. This suggests a straightforward alternative to point source ablation or to the requirement of detailed LAVA intervention. Conclusion: Linear infarct edge homogenization is a straightforward means of ablating ventricular tachycardia’s, even when unstable. This approach may be simpler than seen with LAVA interventions.
Long‐term outcomes with abandoning versus extracting sterile leads: A 10‐year population‐based study
Abstract Background Long‐term outcomes of sterile lead management strategies of lead abandonment (LA) or transvenous lead extraction (TLE) remain unclear. Methods We performed a retrospective study of a population residing in southeastern Minnesota with follow‐up at the Mayo Clinic and its health systems. Patients who underwent LA or TLE of sterile leads from January 1, 2000, to January 1, 2011, and had follow‐up for at least 10 years or until their death were included. Results A total of 172 patients were included in the study with 153 patients who underwent LA and 19 who underwent TLE for sterile leads. Indications for subsequent lead extraction arose in 9.1% ( n = 14) of patients with initial LA and 5.3% ( n = 1) in patients with initial TLE, after an average of 7 years. Moreover, 28.6% of patients in the LA cohort who required subsequent extraction did not proceed with the extraction, and among those who proceeded, 60% had clinical success and 40% had a clinical failure. Subsequent device upgrades or revisions were performed in 18.3% of patients in the LA group and 31.6% in the TLE group, with no significant differences in procedural challenges (5.2% vs. 5.3%). There was no difference in 10‐year survival probability among the LA group and the TLE group ( p = .64). Conclusion An initial lead abandonment strategy was associated with more complicated subsequent extraction procedures compared to patients with an initial transvenous lead extraction strategy. However, there was no difference in 10‐year survival probability between both lead management approaches.
First‐in‐man report of transsubclavian venous implantation of the Aveir leadless cardiac pacing system
Abstract Introduction Transsubclavian venous implantation of the Aveir leadless cardiac pacemaker (LCP) has not been previously reported. Methods and Results Three cases of transsubclavian implantation of the Aveir LCP are reported. Two cases were postbilateral orthotopic lung transplant, without appropriate femoral or jugular access due to recent ECMO cannulation and jugular central venous catheters. In one case, there was strong patient preference for same‐day discharge. Stability testing confirmed adequate fixation and electrical testing confirmed stable parameters in all cases. All patients tolerated the procedure well without significant immediate complications. Conclusions We demonstrate the feasibility of transsubclavian implantation of the Aveir LCP.
Cardiac implantable electronic devices in female patients: Esthetic, breast implant, and anatomic considerations
Abstract Introduction The implantation of a cardiac implantable electronic device (CIED) can have esthetic and psychological consequences on patients. We explore a heart team model for care coordination and discuss esthetic approaches for improved cosmetic outcomes in patients undergoing (CIED)‐related procedures or de novo implantation. Methods Patients undergoing CIED surgery for approved indications between June 2015 and June 2022 were identified. Patients were included when surgical care was provided by a collaborative relationship between the primary electrophysiologist and the plastic surgeon. Patient demographics, details of the surgical procedure, information on breast implants, complications, and outcomes related to cosmesis were recorded. Results Twenty‐two female patients were included in this study. The mean age was 50.2 ± 18.2 years. The mean follow‐up duration was 2.2 ± 5.5 months. The top two indications for the procedure included CIED generator change ( n = 9, 41%) and implantable cardioverter‐defibrillator (ICD) implantation ( n = 7, 32%). The most common reasons for involving plastic surgery in the procedure included surgery near breast implants ( n = 10, 45%) and device displacement or discomfort ( n = 8, 36%). CIED pocket position was prepectoral in 10 cases (45%), subpectoral in 11 patients (50%), and intramuscular in one patient (4.5%). The majority of the patients (20, 91%) had cosmetically acceptable results postprocedure. One patient (4.5%) had breast asymmetry on the CIED side, and another continued to have skin erosion over the CIED and leads. Conclusion A heart team approach incorporating the expertize of cardiac electrophysiology and plastic surgery is essential for providing optimal care for patients with breast implants and patients requesting esthetic appeal.