Outcomes of an expedited same-day discharge protocol following cardiac implantable electronic device (CIED) implantation.

BACKGROUND: With increasing constraints on healthcare resources, greater attention is being focused on improved resource utilization. Prior studies have demonstrated safety of same-day discharge following CIED implantation but are limited by vague protocols with long observation periods. In this study, we evaluate the safety of an expedited 2 hour same-day discharge protocol following CIED implantation. METHODS: Patients undergoing CIED implantation at three centers between 2015 and 2021 were included. Procedural, demographic, and adverse event data were abstracted from the electronic health record. Patients were divided into same-day discharge (SDD) and delayed discharge (DD) cohorts. The primary outcome was complications including lead malfunction requiring revision, pneumothorax, hemothorax, lead dislodgement, lead perforation with tamponade, and mortality within 30 days of procedure. Outcomes were compared between the two cohorts using the χ2 test. RESULTS: A total of 4543 CIED implantation procedures were included with 1557 patients (34%) in the SDD cohort. SDD patients were comparatively younger, were more likely to be male, and had fewer comorbidities than DD patients. Among SDD patients, the mean time to post-operative chest X-ray was 2.6 h. SDD had lower rates of complications (1.3% vs 2.1%, p = 0.0487) and acute care utilization post-discharge (9.6% vs 14.0%, p < 0.0001). There was no difference in the 90-day infection rate between the cohorts. CONCLUSIONS: An expedited 2 hour same-day discharge protocol is safe and effective with low rates of complications, infection, and post-operative acute care utilization.

EsophAguS Deviation During RadiofrequencY Ablation of Atrial Fibrillation: The EASY AF Trial.

BACKGROUND: Injury to the esophagus has been reported in a high percentage of patients undergoing ablation of atrial fibrillation (AF). OBJECTIVES: This study assessed the incidence of esophageal injury in patients undergoing ablation of AF with and without an esophageal deviating device. METHODS: This prospective, randomized, multicenter, double-blinded, controlled Food and Drug Administration investigational device exemption trial compared the incidence of ablation-related esophageal lesions, as assessed by endoscopy, in patients undergoing AF ablation assigned to a control group (luminal esophageal temperature [LET] monitoring alone) compared with patients randomized to a deviation group (esophagus deviation device + LET). This novel deviating device uses vacuum suction and mechanical deflection to deviate a segment of the esophagus, including the trailing edge. RESULTS: The data safety and monitoring board recommended stopping the study early after randomizing 120 patients due to deviating device efficacy. The primary study endpoint, ablation injury to the esophageal mucosa, was significantly less in the deviation group (5.7%) in comparison to the control group (35.4%; P < 0.0001). Control patients had a significantly higher severity and greater number of ablation lesions per patient. There was no adverse event assigned to the device. By multivariable analysis, the only feature associated with reduced esophageal lesions was randomization to deviating device (OR: 0.13; 95% CI: 0.04-0.46; P = 0.001). Among control subjects, there was no difference in esophageal lesions with high power/short duration (31.8%) vs other radiofrequency techniques (37.2%; P = 0.79). CONCLUSIONS: The use of an esophageal deviating device resulted in a significant reduction in ablation-related esophageal lesions without any adverse events.

Outcomes of a Remote Cardiac Rehabilitation Program for Patients Undergoing Atrial Fibrillation Ablation: Pilot Study.

BACKGROUND: Risk factor modification, in particular exercise and weight loss, has been shown to improve outcomes for patients with atrial fibrillation (AF). However, access to structured supporting programs is limited. Barriers include the distance from appropriate facilities, insurance coverage, work or home responsibilities, and transportation. Digital health technology offers an opportunity to address this gap and offer scalable interventions for risk factor modification. OBJECTIVE: This study aims to assess the feasibility and effectiveness of a 12-week asynchronous remotely supervised exercise and patient education program, modeled on cardiac rehabilitation programs, in patients with AF. METHODS: A total of 12 patients undergoing catheter ablation of AF were enrolled in this pilot study. Participants met with an exercise physiologist for a supervised exercise session to generate a personalized exercise plan to be implemented over the subsequent 12-week program. Disease-specific education was also provided as well as instruction in areas such as blood pressure and weight measurement. A digital health toolkit for self-tracking was provided to facilitate monitoring of exercise time, blood pressure, weight, and cardiac rhythm. The exercise physiologist remotely monitored participants and completed weekly check-ins to titrate exercise targets and provide further education. The primary end point was program completion. Secondary end points included change in self-tracking adherence, weight, 6-minute walk test (6MWT), waist circumference, AF symptom score, and program satisfaction. RESULTS: The median participant age was 67.5 years, with a mean BMI of 33.8 kg/m2 and CHADs2VASC (Congestive Heart Failure, Hypertension, Age [≥75 years], Diabetes, Stroke/Transient Ischemic Attack, Vascular Disease, Age [65-74 years], Sex [Female]) of 1.5. A total of 11/12 (92%) participants completed the program, with 94% of expected check-ins completed and 2.9 exercise sessions per week. Adherence to electrocardiogram and blood pressure tracking was fair at 81% and 47%, respectively. Significant reductions in weight, waist circumference, and BMI were observed with improvements in 6MWT and AF symptom scores (P<.05) at the completion of the program. For program management, a mean of 2 hours per week or 0.5 hours per patient per week was required, inclusive of time for follow-up and intake visits. Participants rated the program highly (>8 on a 10-point Likert scale) in terms of the impact on health and wellness, educational value, and sustainability of the personal exercise program. CONCLUSIONS: An asynchronous remotely supervised exercise program augmented with AF-specific educational components for patients with AF was feasible and well received in this pilot study. While improvements in patient metrics like BMI and 6MWT are encouraging, they should be viewed as hypothesis generating. Based on insights gained, future program iterations will include particular attention to improved technology for data aggregation, adjustment of self-monitoring targets based on observed adherence, and protocol-driven exercise titration. The study design will need to incorporate strategies to facilitate the recruitment of a diverse and representative participant cohort.

Dry suction water seal system for management of pericardial fluid during epicardial ablation.

INTRODUCTION: Epicardial ablation is an important approach in the management of patients with complex ventricular arrhythmias. Irrigated ablation catheters present a challenge in this potential space due to fluid accumulation that can cause hemodynamic compromise, requiring frequent manual fluid aspiration. In this series, we report our initial experience with the use of a dry suction water seal system for pericardial fluid management during epicardial ablation. METHODS: Consecutive patients undergoing epicardial ventricular tachycardia (VT) ablation at a single center were included. All patients underwent epicardial access via a subxiphoid approach with a single operator. A deflectable sheath was advanced into the pericardial space, and the side port was attached to a dry suction water seal system attached to wall suction at -20 mmHg. Procedural information including patient characteristics, outcomes, and adverse events. After a period of initial experience, pericardial fluid infusion and aspiration volumes were recorded. RESULTS: Eleven patients were included in this series. All patients underwent epicardial ablation with complete success achieved in 8 of the 11 patients and partial success in the remaining patients. Pericardial fluid intake ranging from 485 to 3050 mL with aspiration of 350-3050 mL using the dry suction water seal system. No adverse events occurred. CONCLUSION: Dry suction water seal drainage systems can provide a safe strategy for efficient pericardial fluid management during epicardial VT ablation, potentially shortening procedure duration.

Outcomes of transvenous lead extraction using the TightRail™ mechanical rotating dilator sheath and excimer laser sheath.

BACKGROUND: Transvenous lead extraction (TLE) is an important part of comprehensive lead management. The selection of tools available has expanded in recent years but data on their efficacy is limited. OBJECTIVE: To evaluate outcomes using the TightRail™ mechanical rotating mechanical dilator sheath in comparison to excimer laser sheaths and describe factors predictive of successful extraction. METHODS: Patients undergoing TLE at a single tertiary center (2013-2019) were included in a prospective registry. Leads targeted for extraction with either an SLS II/Glidelight™ or TightRail™ sheath were included. Outcomes were analyzed on a per-lead basis. Generalized estimating equation (GEE) models were used to assess differences in lead extraction success by extraction tool used while adjusting for nonindependence of multiple leads extracted from the same patient. Covariates included patient comorbidities, lead characteristics, and sheath size. RESULTS: A total of 575 leads extracted from 372 patients were included. Overall success rate was 97%. TightRail™ was the first tool used in 180 (31.3%) leads with success rate of 61.7%; laser sheaths were the first tool in 395 leads (68.7%) with success rate of 67.8%. Predictors of successful extraction included lead age, lead type, and sheath sizing. Extraction success did not differ based on whether a laser or TightRail™ sheath was used (adjusted odds ratio = 0.94; 95% confidence interval = 0.59-1.50). CONCLUSION: The TightRail™ sheath is an effective tool for TLE. Lead age, lead type, and sheath sizing were predictive of successful extraction but sheath type was not. These findings are hypothesis generating and warrant further investigation in a prospective, randomized study.

The Accuracy of Portable Monitoring in Diagnosing Significant Sleep Disordered Breathing in Hospitalized Patients.

BACKGROUND: Polysomnograms are not always feasible when sleep disordered breathing (SDB) is suspected in hospitalized patients. Portable monitoring is a practical alternative; however, it has not been recommended in patients with comorbidities. OBJECTIVE: We evaluated the accuracy of portable monitoring in hospitalized patients suspected of having SDB. DESIGN: Prospective observational study. SETTING: Large, public, urban, teaching hospital in the United States. PARTICIPANTS: Hospitalized patients suspected of having SDB. METHODS: Patients underwent portable monitoring combined with actigraphy during the hospitalization and then polysomnography after discharge. We determined the accuracy of portable monitoring in predicting moderate to severe SDB and the agreement between the apnea hypopnea index measured by portable monitor (AHIPM) and by polysomnogram (AHIPSG). RESULTS: Seventy-one symptomatic patients completed both tests. The median time between the two tests was 97 days (IQR 25-75: 24-109). Forty-five percent were hospitalized for cardiovascular disease. Mean age was 52±10 years, 41% were women, and the majority had symptoms of SDB. Based on AHIPSG, SDB was moderate in 9 patients and severe in 39. The area under the receiver operator characteristics curve for AHIPM was 0.8, and increased to 0.86 in patients without central sleep apnea; it was 0.88 in the 31 patients with hypercapnia. For predicting moderate to severe SDB, an AHIPM of 14 had a sensitivity of 90%, and an AHIPM of 36 had a specificity of 87%. The mean±SD difference between AHIPM and AHIPSG was 2±29 event/hr. CONCLUSION: In hospitalized, symptomatic patients, portable monitoring is reasonably accurate in detecting moderate to severe SDB.

Formulation and in vitro evaluation of Eudragit S-100 coated naproxen matrix tablets for colon-targeted drug delivery system.

The purpose of the present investigation was to prepare matrix tablets of naproxen using a hydrophobic polymer, i.e., Eudragit RLPO, RSPO, and combination of both, by wet granulation method. The tablets were further coated with different concentrations of Eudragit S-100, a pH-sensitive polymer, by dip immerse method. In vitro drug release studies of tablets were carried out in different dissolution media, i.e., 0.1 N HCl (pH 1.2), phosphate buffers pH 6.8 and 7.4, with or without rat cecal content. The swelling studies of the optimized formulation were carried out. The physicochemical parameters of all the formulations were found to be in compliance with the pharmacopoeial standards. The effect of dissolution medium on the surface of matrix tablet was determined by using Scanning Electron Microscopy technique. The stability studies of all formulations were performed as per ICH guidelines. The results demonstrated that the tablets coated with Eudragit S-100 (2% w/v) showed a sustained release of 94.67% for 24 h, but drug release increased to about 98.60% for 24 h in the presence of rat cecal content while the uncoated tablets released the drug within 5 h. With regard to release kinetics, the data were best fitted with the Higuchi model with non-Fickian drug release kinetics mechanism. The stability studies of tablets showed less degradation during accelerated and room temperature storage conditions for 6 months. The enteric-coated Eudragit S-100 coated matrix tablets of naproxen showed promising site-specific drug delivery in the colon region.

Survival implications: hypertrophic cardiomyopathy in Noonan syndrome.

OBJECTIVES: To understand relationships and survival implications between structural heart disease and hypertrophic cardiomyopathy in Noonan syndrome (Noonan syndrome-HCM), we reviewed the clinical course of 138 children with Noonan syndrome diagnosed with cardiovascular abnormalities and compared survival with the 30 children with Noonan syndrome-HCM with 120 contemporaneous children with nonsyndromic HCM. METHODS: Study cohorts represent consecutive cases diagnosed at our institution 1966 through 2006. Outcomes were modeled using multiphase parametric techniques followed by multivariable regression with bagging. RESULTS: Cardiac abnormalities in Noonan syndrome: Cardiac abnormalities in the 138 Noonan syndrome children included pulmonary valve dysplasia (52%), hypertrophic cardiomyopathy (22%), atrial septal defect (20%), ventricular septal defect (10%), mitral valve dysplasia (6%), coarctation (3%), and Fallot's tetralogy (2%). Need for surgery was high but not different from children with structural defects coexisting with HCM. Overall, late survival in children with Noonan syndrome and cardiac defects was good (91 ± 3% at 15 years), although significantly worse for those with Noonan syndrome-HCM (P < .01). Noonan syndrome-HCM vs. nonsyndromic HCM: In the 30 children with Noonan syndrome-HCM, structural cardiac malformations coexisted in 18 (57%). The incidence of structural cardiac malformations in nonsyndromic HCM was instead 3/120 (2.5%, P < .001). Risk-adjusted late survival was significantly worse for Noonan syndrome-HCM than for nonsyndromic HCM (P= .02). CONCLUSIONS: Noonan syndrome-HCM frequently coexists with structural cardiac malformations, whereas nonsyndromic HCM does not; their natural histories may therefore be different. Late survival is significantly worse for Noonan syndrome-HCM than nonsyndromic HCM.

Latent development of occlusive coronary atherosclerosis as a cause of decompensation of non-ischemic dilated cardiomyopathy.

Four patients with chronically well-compensated, non-ischemic dilated cardiomyopathy (NIDC) presented with occlusive atherosclerotic coronary artery disease as the cause of subacute decompensation (FC III-IV heart failure) 8-13 years following the diagnosis of NIDC. In addition to the atherogenic condition of heart failure, 3 of the patients acquired major atherosclerotic risk factors (dyslipidemia, diabetes mellitus) during the interval between the diagnoses of NIDC and problematic atherosclerotic coronary disease. For each patient, dyspnea on exertion was the primary symptom during the subacute decompensation. Only 1 patient noted precordial chest pain in the form of atypical angina during some of the dyspneic events. The diagnosis of occlusive coronary artery disease was made by coronary angiography, followed by angioplasty-stent deployment in 3 patients and coronary artery bypass surgery in 1; all improved to their baseline FC I-II status following these coronary interventions. As survival of patients with NIDC increases, occlusive coronary artery disease may enter an otherwise stable clinical course to provoke unanticipated decompensation (principally dyspnea), and can do so without causing angina pectoris as a heralding symptom.

Comparison of computed tomography imaging with intraprocedural contrast esophagram: implications for catheter ablation of atrial fibrillation.

BACKGROUND: Computed tomography (CT) has been used to localize the esophagus before radiofrequency ablation (RFA) of atrial fibrillation (AF). OBJECTIVE: The purpose of this study was to compare esophageal imaging by CT versus esophagram. METHODS: CT imaging of the left atrium was performed in 57 patients 1 week before RFA and was imported into the CARTO mapping system. The electrophysiologist created a virtual shell of the left atrium and pulmonary veins (PVs) that was merged with the CT image; however, the CT-defined location of the esophagus was not displayed. The patient was then given 10 mL of oral contrast. Using fluoroscopy, an electroanatomic catheter tagged the esophageal borders outlined by esophagram. The CT-defined esophagus was then imported, and the borders were tagged on the merged map. In this manner, the esophagus borders by esophagram versus those by CT were compared. RESULTS: The maximum diameter of the esophagus by esophagram versus CT was not different (16.3 +/- 3.4 vs. 16.5 +/- 3.1 mm; P = .7). The esophagus was near the left PVs in 34 (62%), center in 13 (24%), and near the right PVs in eight (15%) patients. There was concordance between CT and esophagram in 48 of 55 patients (87%; P = .2). Ye, in 21 (44%) of 48 patients with concordant location, the CT-defined esophageal borders were separated from the esophagram-defined borders by >or=50% of the esophagus diameter. CONCLUSIONS: Reliance on remotely acquired CT images does not ensure adequate intraprocedural localization of the esophagus or enhance recognition of esophageal motility.

Complications of pediatric cardiac catheterization: a review in the current era.

OBJECTIVE: To determine types of complications and risks associated with pediatric cardiac catheterization in the current era. BACKGROUND: Pediatric cardiac catheterization is an important diagnostic and therapeutic tool. Although in the last decade, there have been significant improvements in technology and equipment, the risk for complications remains, adversely effecting outcomes. DESIGN: The clinical records of 11,073 children undergoing cardiac catheterizations between January 1994 and March 2006 were reviewed to identify procedures associated with complications within the first 24 h after catheterization. All children's electronic and paper chart records were reviewed to obtain demographic, procedural, and treatment data. RESULTS: A total of 858 (7.3%) complications (classified as major or minor) occurred in 816 studies (510 males, 63%), in children ranging in age from 8 h to 20 years (median 4.13 years). There were 195 major (22%) and 663 (78%) minor complications. Vascular complications represented the majority (n = 278; 32.4%) and were major in 53 instances (P < 0.0001). Twenty-five children died within 24 h (0.23% of total case numbers). Independent risk factors for a complication included young patient age (<6 months), male gender, inpatient status, and year of catheterization. CONCLUSIONS: Complications continue to be associated with pediatric cardiac catheterization, although overall incidence appears to be decreasing. Patient age, gender, and inpatient status continue to be risk factors for morbidity and mortality. Efforts at improving equipment for flexibility and size, and developing strategies for the use of alternative methods for catheter access should be encouraged.

Successful ablation of focal left atrial tachycardia using Stereotaxis Niobe remote magnetic navigation system.

Stereotaxis Niobe remote magnetic navigation system (MNS) (St Louise, USA), is a new technology that has applications in the field of catheter based ablation treatment of cardiac arrhythmias. Most if not all data on the feasibility, safety, and efficacy of the Stereotaxis Niobe MNS comes from select centres where highly skilled personnel have acquired considerable experience using this technology. Herein, we report a case where the Stereotaxis Niobe MNS was successfully used to perform remotely-controlled high density three-dimensional electroanatomical mapping and radiofrequency ablation of a focal atrial tachycardia originating from the anteroseptal region of the left atrium.

Verapamil-sensitive left posterior fascicular ventricular tachycardia after myocardial infarction.

Verapamil-sensitive fascicular ventricular tachycardia (VT) of right bundle branch block (RBBB) and superior axis pattern is typically seen in young patients with structurally normal hearts and considered "idiopathic". Recently, involvement of the Purkinje system in post-infarction monomorphic VT that mimics such idiopathic fascicular VT has been described. In this report we describe a case of a patient who following myocardial infarction developed left posterior fascicular Purkinje reentrant VT that was sensitive to verapamil. The VT was successfully treated by radiofrequency ablation guided by three dimensional electroanatomical CARTO mapping. Our case highlights that involvement of Purkinje fibers should be considered in post infarction patients with VT of narrow QRS duration, RBBB morphology and superior axis. Recognition of such VT is clinically important, as this arrhythmia is amenable to curative catheter ablation.

Percutaneous coronary artery fistula closure in adults: technical and procedural aspects.

BACKGROUND: Coronary artery fistulae (CAF) are an uncommon congenital anomaly characterized by an abnormal connection between the coronary arteries and cardiac chambers or vessels without traversing the usual capillary network. CAF are associated with a number of well-described symptomatic sequelae, which may necessitate treatment. With a tendency for symptoms to develop over time, symptomatic CAF may present for the first time in adulthood, with limited data existing on the technical aspects related to transcatheter fistula closure in adults. METHODS: We describe our experience in percutaneous closure of CAF in an exclusively adult population, with an emphasis on the various procedural features of device closure in this patient group. RESULTS: Attempted transcatheter CAF closure was performed in 14 patients between 1990 and 2006. Procedural success was achieved in 11 patients, with vessel tortuosity and lumen caliber important limitations in occlusion device delivery. Procedural complications included vessel dissection and device embolization. CONCLUSION: Transcatheter occlusion is a safe and effective method of therapy for symptomatic adults with CAF.

Feasibility and clinical impact of transcatheter closure of interatrial communications after a fenestrated Fontan procedure: medium-term outcomes.

OBJECTIVE: This study was to review an institutional experience with transcatheter closure of Fontan fenestrations and its impact on clinical care. BACKGROUND: An interatrial fenestration improves postoperative outcomes in high-risk children undergoing a Fontan repair. While technical feasibility has been well defined, the clinical impact of subsequent closure is not well defined. METHODS: Transcatheter closure of a surgically created or additional interatrial communication was attempted in 152 children at a median interval of 13.8 months after surgery. The clinical records were reviewed for demographic and anatomical characteristics, previous surgeries; catheterization data, and status at latest follow-up. RESULTS: Mean oxygen saturation and right atrial pressure increased acutely from 87% +/- 5% to 96% +/- 3% (P < 0.001) and 12 +/- 2 mm Hg to 13 +/- 3 mm Hg (P < 0.001), respectively. Higher systemic venous atrial pressures after occlusion correlated with higher pulmonary artery pressures (P = 0.05) before the Fontan procedure and with higher right (P < 0.001) and left atrial (P = 0.001) and ventricular end-diastolic pressures (P < 0.001) immediately before occlusion. Complications included device malposition in 2 children, 1 child each had an air embolism and post-procedural bleeding, and each self-limiting and 1 child had acute ST elevation in inferior ECG leads because of occlusion of the acute marginal branch which was treated with angioplasty and placement of a stent. At follow-up (median 4.5 years), the mean oxygen saturation was 95% +/- 3%. Residual interatrial leaks were noted echocardiographically in 9%. Two children developed protein-losing enteropathy after fenestration closure. No deaths or strokes were observed in follow-up. CONCLUSIONS: Transcatheter occlusion of Fontan fenestrations is safe with acute and persistent improvements in oxygen saturations.