Contemporary trends of leadless pacemaker implantation in the United States.

INTRODUCTION: Leadless pacemakers (LPM) have established themselves as the important therapeutic modality in management of selected patients with symptomatic bradycardia. To determine real-world utilization and in-hospital outcomes of LPM implantation since its approval by the Food and Drug Administration in 2016. METHODS: For this retrospective cohort study, data were extracted from the National Inpatient Sample database from the years 2016-2020. The outcomes analyzed in our study included implantation trends of LPM over study years, mortality, major complications (defined as pericardial effusion requiring intervention, any vascular complication, or acute kidney injury), length of stay, and cost of hospitalization. Implantation trends of LPM were assessed using linear regression. Using years 2016-2017 as a reference, adjusted outcomes of mortality, major complications, prolonged length of stay (defined as >6 days), and increased hospitalization cost (defined as median cost >34 098$) were analyzed for subsequent years using a multivariable logistic regression model. RESULTS: There was a gradual increased trend of LPM implantation over our study years (3230 devices in years 2016-2017 to 11 815 devices in year 2020, p for trend <.01). The adjusted mortality improved significantly after LPM implantation in subsequent years compared to the reference years 2016-2017 (aOR for the year 2018: 0.61, 95% CI: 0.51-0.73; aOR for the year 2019: 0.49, 95% CI: 0.41-0.59; and aOR for the year 2020: 0.52, 95% CI: 0.44-0.62). No differences in adjusted rates of major complications were demonstrated over the subsequent years. The adjusted cost of hospitalization was higher for the years 2019 (aOR: 1.33, 95% CI: 1.22-1.46) and 2020 (aOR: 1.69, 95% CI: 1.55-1.84). CONCLUSION: The contemporary US practice has shown significantly increased implantation rates of LPM since its approval with reduced rates of inpatient mortality.

Pericardial effusion requiring intervention in patients undergoing leadless pacemaker implantation: A real-world analysis from the National Inpatient Sample database.

Background: Pericardial effusion requiring percutaneous or surgical-based intervention remains an important complication of a leadless pacemaker implantation. Objective: The study sought to determine real-world prevalence, risk factors, and associated outcomes of pericardial effusion requiring intervention in leadless pacemaker implantations. Methods: The National Inpatient Sample and International Classification of Diseases-Tenth Revision codes were used to identify patients who underwent leadless pacemaker implantations during the years 2016 to 2020. The outcomes assessed in our study included prevalence of pericardial effusion requiring intervention, other procedural complications, and in-hospital outcomes. Predictors of pericardial effusion were also analyzed. Results: Pericardial effusion requiring intervention occurred in a total of 325 (1.1%) leadless pacemaker implantations. Patient-level characteristics that predicted development of a serious pericardial effusion included >75 years of age (odds ratio [OR] 1.38, 95% confidence interval [CI] 1.08-1.75), female sex (OR 2.03, 95% CI 1.62-2.55), coagulopathy (OR 1.50, 95% CI 1.12-1.99), chronic pulmonary disease (OR 1.36, 95% CI 1.07-1.74), chronic kidney disease (OR 1.53, 95% CI 1.22-1.94), and connective tissue disorders (OR 2.98, 95% CI 2.02-4.39). Pericardial effusion requiring intervention was independently associated with mortality (OR 5.66, 95% CI 4.24-7.56), prolonged length of stay (OR 1.36, 95% CI 1.07-1.73), and increased cost of hospitalization (OR 2.49, 95% CI 1.92-3.21) after leadless pacemaker implantation. Conclusion: In a large, contemporary, real-world cohort of leadless pacemaker implantations in the United States, the prevalence of pericardial effusion requiring intervention was 1.1%. Certain important patient-level characteristics predicted development of a significant pericardial effusion, and such effusions were associated with adverse outcomes after leadless pacemaker implantations.

Physical Activity is Associated with a Decreased Risk of Developing Inflammatory Bowel Disease: A Systematic Review and Meta-analysis.

BACKGROUND AND AIMS: Modifiable risk factors in inflammatory bowel disease [IBD], such as physical activity, may be used as prevention strategies. However, the findings of previous studies on the association between physical activity and IBD risk have been inconsistent. We aimed to perform a systematic review and meta-analysis to estimate the effect of physical activity on IBD risk. METHODS: A search was conducted for relevant studies published before April 2023 that assessed the effect of pre-IBD diagnosis levels of physical activity on IBD incidence. Individual summary statistics [relative risks; RR], and confidence intervals [CI] were extracted with forest plots generated. We used the Grading of Recommendations Assessment, Development and Evaluation [GRADE] approach to assess the quality of evidence. RESULTS: Ten observational studies were included. For cohort studies, there were 1182 Crohn's disease [CD] and 2361 ulcerative colitis [UC] patients, with 860 992 participants without IBD. For case-control studies, there were 781 CD to 2636 controls, and 1127 UC to 3752 controls. Compared with individuals with low physical activity levels, the RRs of CD in individuals with high physical activity levels for cohort and case-control studies were 0.78 [95% CI 0.68-0.88, p = 0.0001] and 0.87 [95% CI 0.79-0.95, p = 0.003], respectively. For UC, the RRs were 0.62 [95% CI 0.43-0.88, p = 0.008] and 0.74 [95% CI 0.51-1.07, p = 0.11]. CONCLUSION: This meta-analysis suggests that physical activity is inversely associated with the risk of developing IBD, more so in CD than in UC.

Association of chronic kidney disease and end-stage renal disease with procedural complications and inpatient outcomes of leadless pacemaker implantations across the United States.

BACKGROUND: Leadless pacemakers have emerged as a promising alternative to transvenous pacemakers in patients with kidney disease. However, studies investigating leadless pacemaker outcomes and complications based on kidney dysfunction are limited. OBJECTIVE: The objective of this study was to evaluate the association of chronic kidney disease (CKD) and end-stage renal disease (ESRD) with inpatient complications and outcomes of leadless pacemaker implantations. METHODS: National Inpatient Sample and International Classification of Diseases, Tenth Revision codes were used to identify patients with CKD and ESRD who underwent leadless pacemaker implantations in the United States from 2016 to 2020. Study end points assessed included inpatient complications, outcomes, and resource utilization of leadless pacemaker implantations. RESULTS: A total of 29,005 leadless pacemaker placements were identified. Patients with CKD (n = 5245 [18.1%]) and ESRD (n = 3790 [13.1%]) were younger than patients without CKD and had higher prevalence of important comorbidities. In crude analysis, ESRD was associated with higher prevalence of major complications, peripheral vascular complications, and inpatient mortality. After multivariable adjustment, CKD and ESRD were associated with inpatient mortality (CKD: adjusted odds ratio [aOR], 1.62 [95% CI, 1.40-1.86]; ESRD: aOR, 1.38 [95% CI, 1.18-1.63]) and prolonged length of stay (CKD: aOR, 1.55 [95% CI, 1.46-1.66]; ESRD: aOR, 1.81 [95% CI 1.67-1.96]). ESRD was also associated with higher hospitalization costs (aOR, 1.63; 95% CI, 1.50-1.77) and major complications (aOR, 1.33; 95% CI, 1.13-1.57) after leadless pacemaker implantation. CONCLUSION: Approximately one-third of patients undergoing leadless pacemaker implantation had CKD or ESRD. CKD and ESRD were associated with greater length and cost of stay and inpatient mortality.

Different leadless pacemakers working in harmony (Aveir in the atrium/Micra AV2 in the ventricle) in a patient with dextrocardia and double outlet right ventricle after high-risk infected device extraction.

INTRODUCTION: Patients with congenital heart disease are at increased risk for requiring cardiac pacing during their lifetime. METHODS: We present the first described case of using two leadless pacing systems manufactured by separate companies implanted within the same patient to provide atrial and ventricular pacing due to complex congenital anatomy. RESULTS: A 27-year-old male with dextrocardia with double outlet right ventricle, subaortic ventricular septal defect, and pulmonary stenosis status-post pulmonary valve replacement complicated by ventricular pacing dependence and subsequent atrial pacing dependence after atriotomy-based atypical flutter ablation developed recurrent mediastinitis and pocket infection with erosion despite prolonged antibiotic treatment. Due to atrial and ventricular pacing dependence, a comprehensive congenital care team concluded the need for lead extraction and replacement of pacemaker via leadless peacemaking device. Laser-lead extraction and temporary atrial pacemaker placement was performed. Afterward, a transesophageal echocardiogram guided implantation of both a Micra AV 2 (Medtronic) leadless pacemaker in the interventricular septum within the right ventricle and an Aveir (Abbott) leadless pacemaker in the superior base of the right atrial appendage was performed with successful pacing. Although there is no communication between these devices, atrial-mechanical ventricular pacing was reliable with good implant thresholds, impedances and sensing from both devices. CONCLUSION: Our case demonstrates the feasibility of using dual leadless pacing modalities to simultaneously pace someone at complex, prohibitive risk for temporary permanent or permanent pacemaker devices.

2023 Chinese expert consensus on the impact of COVID-19 on the management of cardiovascular diseases.

The primary site of infection in COVID-19 exhibit is the respiratory system, but multiple organ systems could be affected. The virus could directly invade cardiomyocytes. Alternatively, cytokine storm could lead to myocardial injury. More importantly, the management of existing cardiovascular diseases must be re-examined in COVID-19 due to, for example, interaction between antiviral agents and with a wide variety of pharmacological agents. The Branch of Cardiovascular Physicians of Chinese Medical Doctor Association organized a panel of experts in cardiovascular and related fields to discuss this important issue, and formulated the "2023 Chinese Expert Consensus on the Impact of COVID-19 on the Management of Cardiovascular Diseases." The Consensus was drafted on the basis of systematic review of existing evidence and diagnosis and treatment experience, and covers three major aspects: myocardial injury caused by COVID-10 and COVID-19 vaccine, the impact of COVID-19 on patients with cardiovascular disease, and the impact of COVID-19 on the cardiovascular system of healthy people, and rehabilitation guidance recommendations. The Consensus involves 11 core clinical issues, including incidence, pathogenesis, clinical manifestations, treatment strategies, prognosis, and rehabilitation. It is our hope that this Consensus will provide a practical guidance to cardiologists in the management of cardiovascular diseases in the new era of COVID-19 pandemic.

Exploratory use of intraprocedural transesophageal echocardiography to guide implantation of the leadless pacemaker.

Background: Fluoroscopy is the standard tool for transvenous implantation of traditional and leadless pacemakers (LPs). LPs are used to avoid complications of conventional pacemakers, but there still is a 6.5% risk of major complications. Mid-right ventricular (RV) septal device implantation is suggested to decrease the risk, but helpful cardiac landmarks cannot be visualized under fluoroscopy. Transesophageal echocardiography (TEE) is an alternative intraprocedural imaging method. Objective: The purpose of this study was to explore the spatial relationship of the LP to cardiac landmarks via TEE and their correlations with electrocardiographic (ECG) parameters, and to outline an intraprocedural method to confirm mid-RV nonapical lead positioning. Methods: Fifty-six patients undergoing implantation of LP with TEE guidance were enrolled in the study. Device position was evaluated by fluoroscopy, ECG, and TEE. Distances between the device and cardiac landmarks were measured by TEE and analyzed with ECG parameters with and without RV pacing. Results: Mid-RV septal positioning was achieved in all patients. TEE transgastric view (0°-40°/90°-130°) was the optimal view for visualizing device position. Mean tricuspid valve-LP distance was 4.9 ± 0.9 cm, mean pulmonary valve-LP distance was 4.2 ± 1 cm, and calculated RV apex-LP distance was 2.9 ± 1 cm. Mean LP paced QRS width was 160.8 ± 28 ms and increased from 117.2 ± 34 ms at baseline. LP RV pacing resulted in left bundle branch block pattern on ECG and 37.8% QRS widening by 43.5 ± 29 ms. Conclusion: TEE may guide LP implantation in the nonapical mid-RV position. Further studies are required to establish whether this technique reduces implant complications compared with conventional fluoroscopy.

The disease severity index for inflammatory bowel disease is associated with psychological symptoms and quality of life, and predicts a more complicated disease course.

BACKGROUND: The Disease Severity Index (DSI) is a novel tool to predict disease severity in inflammatory bowel disease (IBD). However, its ability to predict disease complications and the presence of psychosocial comorbidity is unclear. AIMS: To assess prospectively associations between the DSI and psychological symptoms, quality-of-life (QoL) and disease outcomes in an IBD cohort. METHODS: Patients with IBD undergoing ileocolonoscopy were followed prospectively for 12 months. DSI, psychological symptoms (perceived stress (PSS-10), depression (PHQ-9), anxiety (GAD-7)) and QoL (IBDQ-32) scores were assessed at baseline. Logistic regression identified variables predicting a complicated IBD course at 12 months (composite outcome of need for escalation of biological/immunomodulator for disease relapse, recurrent corticosteroid use, IBD-related hospitalisation and surgery). Receiver operating characteristics (ROC) analysis identified optimal DSI thresholds predicting a complicated disease course and multivariable logistic regression assessed the risk of reaching this outcome. RESULTS: One hundred and seventy-two patients were recruited (100 Crohn's disease, 91 female). Median DSI was 21 (IQR 11-32) and 97 patients had endoscopically active disease at baseline. The DSI was significantly higher in patients with symptoms of moderate-severe stress (PSS-10 > 14, p < 0.01), depression (PHQ-9 ≥ 10, p < 0.01), anxiety (GAD-7 ≥ 10, p < 0.05) and impaired quality-of-life (IBDQ-32 < 168, p < 0.01). Only the baseline DSI (OR 1.05, p < 0.01) and endoscopically active disease (OR 6.12, p < 0.01) were associated with a complicated IBD course. A DSI > 23 was strongly predictive of a complicated IBD course (OR 8.31, p < 0.001). CONCLUSIONS: The DSI is associated with psychological distress, impaired QoL and predicts a more complicated disease course in patients with IBD.

Effects of Supervised Exercise Training on Atrial Fibrillation: A META-ANALYSIS OF RANDOMIZED CONTROLLED TRIALS.

PURPOSE: Atrial fibrillation (AF) is associated with the comorbidities of a sedentary lifestyle. Endurance athletes also show an increased incidence of AF. The role of exercise in the treatment of AF is unknown so this study aimed to examine the effects of supervised exercise on AF. METHODS: A meta-analysis of randomized controlled trials (RCTs) examining supervised exercise training in participants with AF was performed. The primary outcome was AF recurrence and burden. Secondary outcomes included AF symptoms, quality of life, and cardiorespiratory fitness (CRF). RESULTS: Thirteen RCTs, involving 1155 participants, were included. Paroxysmal AF was present in 34% and persistent AF in 64%. The types of exercise were diverse and included cardiac rehabilitation (64%), aerobic training (7%), Qi Gong (4%), interval training (11%), and yoga (15%). Exercise training reduced AF recurrence (relative risk = 0.77: 95% CI, 0.60-0.99), improved quality of life in 5 of the 10 components of the Short Form 36 survey, and improved CRF (standardized mean difference [SMD] = 0.56: 95% CI, 0.27-0.85). The AF burden was reduced only in studies that included continuous ambulatory monitoring (SMD =-0.49: 95% CI, -0.96 to -0.01) but not when all studies were included (SMD =-0.12: 95% CI, -0.61 to 0.38). There was no difference in adverse events between exercise and control. CONCLUSIONS: Supervised exercise training is safe, reduces AF recurrence, and improves quality of life and CRF in participants with AF. Further large RCTs with ambulatory monitoring and robust exercise regimens are needed to assess the effects of exercise training on AF burden and AF symptoms.

Contrast-enhanced transesophageal echocardiography predicts neo-intimal coverage of device post-left atrial appendage closure.

BACKGROUND: Left atrial appendage (LAA) closure (LAAC) is a viable alternative to anticoagulation for stroke prevention in non-valvular atrial fibrillation. However, device-associated thrombosis (DAT) is known as a complication of LAAC as observed within the first few weeks after implantation. A noninvasive method is needed to predict the progress for endothelialization surveillance. The aim of the study was to develop a noninvasive visual contrast-enhanced transesophageal echocardiography (cTEE) method for monitoring the communication between left atrium (LA) and LAA post-LAAC by cTEE-score evaluating the contrast enhancement in LAA. METHODS: A total of 29 healthy dogs were studied by LAAC at < 24 h and 1, 2, 3 and 6-months. The LAAC procedure was assessed by TEE with color Doppler flow imaging (CDFI) and contrast imaging. The cTEE score was calculated based on the differential contrast opacification of LA and LAA cavities, the CDFI on the width of peri-device color flow, and that of histology on the level of occluder surface endothelialization in postmortem histological examination. Spearman's correlation analysis was used to correlate these scores. RESULTS: The correlation between cTEE and histology scores was superior to that between CDFI and histology scores. The trend of average cTEE score was tracked with that of histology, while that of CDFI was far from that of histology. The correlation coefficient of CDFI and histology scores was not significant (p > 0.05). CONCLUSIONS: The noninvasive visual cTEE is feasible and reliable to monitor communication between the LA and LAA post-LAAC. cTEE is superior to CDFI as a tool in predicting the progress for endothelialization surveillance.

A comparison of major trauma admissions to Christchurch Hospital during and after COVID-19 lockdown in New Zealand.

AIMS: To describe any change in the volume and mechanisms of injury of major trauma admissions during and after COVID-19 lockdown, and in doing so, to provide information for resource planning and identification of priority areas for injury prevention initiatives. METHODS: A retrospective, descriptive study conducted on Canterbury District Health Board trauma registry data. The study population consisted of all major trauma patients of all age groups admitted to Christchurch Hospital over three 33-day periods: before, during and after COVID-19 lockdown in New Zealand. Broadly speaking, major trauma is defined as having an injury severity score 13 or death following injury. RESULTS: There was a 42% reduction in the volume of major trauma admissions during lockdown. Falls were the most common injury during lockdown, and transport-related injuries after lockdown. Alcohol intoxication was associated with 19 to 33% of all injuries across the study periods. CONCLUSION: Major trauma inevitably occurred during lockdown, although at considerably lower volumes. After lockdown, once restrictions were eased, major trauma admissions reverted to pre-lockdown patterns. Injury prevention strategies can reduce avoidable pressures on hospitals at a time of pandemic. In New Zealand, focus should be placed on reducing alcohol- and transport-related injuries and increasing community awareness on falls prevention.

Electrical abnormalities with St. Jude/Abbott pacing leads: A systematic review and meta-analysis.

BACKGROUND: Although there is a paucity of contemporary data on pacemaker lead survival rates, small studies suggest that some leads may have higher malfunction rates than do others. OBJECTIVE: The purpose of this study was to determine the malfunction rates of current pacemaker leads. METHODS: A meta-analysis including studies that examined the non-implant-related lead malfunction rates of current commercially available active fixation pacemaker leads was performed. An electronic search of MEDLINE/PubMed, Scopus, and Embase was performed. DerSimonian and Laird random effects models were used. RESULTS: Eight studies with a total of 14,579 leads were included. Abbott accounted for 10,838 (74%), Medtronic 2510 (17%), Boston Scientific 849 (6%), and MicroPort 382 (3%) leads. The weighted mean follow-up period was 3.6 years. Lead abnormalities occurred in 5.0% of all leads, 6.1% of Abbott leads, 1.1% of Medtronic, 1.4% of Boston Scientific, and 5.5% of MicroPort. The most common lead abnormality was lead noise with normal impedance. Abbott leads were associated with an increased risk of abnormalities (relative risk [RR] 7.81; 95% confidence interval [CI] 3.21-19.04), reprogramming (RR 7.95; 95% CI 3.55-17.82), and lead revision or extraction (RR 8.91; 95% CI 3.36-23.60). Abbott leads connected to an Abbott generator had the highest abnormality rate (8.0%) followed by Abbott leads connected to a non-Abbott generator (4.7%) and non-Abbott leads connected to an Abbott generator (0.4%). CONCLUSIONS: Abbott leads are associated with an increased risk of abnormalities compared with leads of other manufacturers, primarily manifesting as lead noise with normal impedance, and are associated with an increased risk of lead reprogramming and lead revision or extraction.

Adjunctive use of fluoroscopy during MitraClip implantation reduces procedural complexity: The parallax technique.

BACKGROUND: During MitraClip implantation sub-valvular correction of trajectory and/or alignment may increase adverse clip or leaflet events. With systematic adjunctive use of fluoroscopy ("Parallax technique"), we aimed to assess parameters that minimize the need for corrective measures and help increase procedural efficiency. METHODS: We retrospectively analyzed 30 patients without (Fl-) and 39 patients utilizing adjunctive fluoroscopy (Fl+) during MitraClip implantation. After establishing trajectory and supra-valvular alignment, the Parallax technique was utilized. Trajectory and alignment are maintained during advancement. RESULTS: All patients had 3 or 4+ MR. There were no differences in baseline demographics. The average number of clips (Fl- vs Fl+) was 1.72 ± 0.8 vs 1.59 ± 0.5, p = .57. For the first clip, the need for sub-valvular alignment (80% vs. 36%, p = .0001), eversion with retraction back to left atrium (23% vs. 10%, p = .001) and the number of grasps (2.3 ± 1.2 vs 1.4 ± 0.9) was reduced. The time from transseptal puncture to first clip deployment (71 ± 21 vs 44 ± 16 min, p = .01) was reduced. Procedural success was achieved in all but one patient in the Fl- group (p = ns). There were no differences noted for in-hospital or 30-day outcomes. CONCLUSIONS: Systematic use of a simple and easy to implement "Parallax technique" was associated with reduced need for sub-valvular manipulation and was associated with improved procedural times. Further larger scale studies are needed to assess the applicability of the technique.

A novel clock-face method for characterizing peridevice leaks after left atrial appendage occlusion.

OBJECTIVES: To propose a novel method for mapping leak location and frequency to a clock-face representation of the left atrial appendage (LAA) ostium. BACKGROUND: LAA occlusion with the Watchman device (WD) is an established therapy to reduce thromboembolic events in patients with atrial fibrillation (AF) and intolerance to long-term oral anticoagulation. Postimplantation leaks are known sequelae, but leak locations and characteristics are poorly described. METHODS: We retrospectively reviewed 101 consecutive WD implants from April 2015 to February 2018. Leak locations from 6-week post-implant transesophageal echocardiograms were mapped to a clock-face representation of the LAA ostium: 12:00 as cranial near the limbus, 3:00 as anterior toward the pulmonary artery, 6:00 as caudal near the mitral annulus, and 9:00 as posterior. Patient demographics, LAA dimensions, and procedural characteristics were also collected. RESULTS: Thirty-four patients had ≥1 leak totaling 45 leaks at 6-week follow-up. Baseline patient demographics showed a mean age 77, CHA2 DS2 VASc 4.69, and 64% of patients with permanent AF. No patient had a detectable leak at the time of implant. At 6 weeks, mean leak size was 2.67 ± 0.89 mm with no leak over 5 mm (largest 4.60 mm). Most leaks occurred along the posterior 6:00-12:00 segment (39/45) and the 6:00-9:00 quadrant (16/45). CONCLUSION: Six-week post-WD implant leaks localize to the posterior LAA ostium. This could result from the elliptical LAA orifice, differential LAA tissue composition, or implantation technique. This study provides a novel method for describing the location of post-implant leaks and serves as the basis for further investigations.

Patient Perception of the Remote Versus Clinic Visits for Interrogation of Implantable Cardioverter Defibrillators.

Implantable Cardioverter Defibrillators (ICDs) are used in the management of sudden cardiac arrest. Compared with clinic visits, remote interrogation of these devices has shown clinical benefit and lower cost. We hypothesize that demographic and socioeconomic factors influence patient satisfaction with remote monitoring and therefore the choice of a pathway for follow-up. Questionnaires were mailed to 85 patients (mean age 63 ± 13.5 years, 73% male), with ICDs implanted for primary prevention of sudden cardiac arrest. Information regarding education, social support, employment, and income was collected. To compare clinic and remote monitoring, patients were given questionnaires to assess which parameters they consider important: convenience, accuracy, human contact, scheduling, and cost. Of the 34 responders, patients rated clinic visit to be as accurate with better opportunity to ask questions and better human contact, but there was no difference in perception of convenience, scheduling, or cost between the 2 groups. Significant number of patients dropped from the labor market after ICD implantation; however labor status, education, or income did not influence the preference of clinic appointment. Survey respondents preferred clinic to remote interrogation because they believe clinic appointments allow better interaction. Educating patients about the benefits of remote interrogation and improved communication will enhance utilization of this sophisticated technology for superior patient care.