2023 HRS/EHRA/APHRS/LAHRS Expert Consensus Statement on Practical Management of the Remote Device Clinic.

Remote monitoring is beneficial for the management of patients with cardiovascular implantable electronic devices by impacting morbidity and mortality. With increasing numbers of patients using remote monitoring, keeping up with higher volume of remote monitoring transmissions creates challenges for device clinic staff. This international multidisciplinary document is intended to guide cardiac electrophysiologists, allied professionals, and hospital administrators in managing remote monitoring clinics. This includes guidance for remote monitoring clinic staffing, appropriate clinic workflows, patient education, and alert management. This expert consensus statement also addresses other topics such as communication of transmission results, use of third-party resources, manufacturer responsibilities, and programming concerns. The goal is to provide evidence-based recommendations impacting all aspects of remote monitoring services. Gaps in current knowledge and guidance for future research directions are also identified.

2023 HRS/EHRA/APHRS/LAHRS Expert Consensus Statement on Practical Management of the Remote Device Clinic.

Remote monitoring is beneficial for the management of patients with cardiovascular implantable electronic devices by impacting morbidity and mortality. With increasing numbers of patients using remote monitoring, keeping up with higher volume of remote monitoring transmissions creates challenges for device clinic staff. This international multidisciplinary document is intended to guide cardiac electrophysiologists, allied professionals, and hospital administrators in managing remote monitoring clinics. This includes guidance for remote monitoring clinic staffing, appropriate clinic workflows, patient education, and alert management. This expert consensus statement also addresses other topics such as communication of transmission results, use of third-party resources, manufacturer responsibilities, and programming concerns. The goal is to provide evidence-based recommendations impacting all aspects of remote monitoring services. Gaps in current knowledge and guidance for future research directions are also identified.

Creating Interdisciplinary Engagement Through a Hospital-Based Endowed Chair in Nursing Research: The "Conway Chair Conversations".

Although clinical nurses' involvement in research is a role expectation, efforts to engage clinical nurses in nurse-led research have had notably mixed results. These efforts have most typically been single discipline-focused (nursing), although nursing care is a collaborative, interdisciplinary practice. Adding an interdisciplinary strategy to multiple other efforts to engage clinical nurses in research may contribute to more nurse involvement. Here, we describe the use of a hospital-based endowed chair in nursing research to simultaneously engage nursing and other disciplines in a monthly dialogue about clinically relevant, research-related challenges and solutions. Outcomes indicate that the research-related dialogue among nurses and interprofessional colleagues would likely not have taken place without this approach.

Mindful Mentors: Is a Longitudinal Mind-Body Skills Training Pilot Program Feasible for Pediatric Cardiology Staff?

BACKGROUND: Stress and burnout among medical professionals are common and costly, placing professionals, organizations, and patients at risk. OBJECTIVES: To determine feasibility and acceptability of a longitudinal mind-body skills training initiative to help staff decrease stress and burnout, improve well-being, and empower them to utilize basic mindfulness methods with coworkers, patients, and families. METHODS: Prospective cohort, mixed methods approach. Nurses, doctors, technicians, social workers, child life specialists were eligible to participate. The 12-month curriculum consisted of 16 hours of intensive education/practice over 2 days, with training in mindfulness skills, self-compassion, nonviolent communication, overcoming barriers to practice, and mindful listening/speaking, followed by monthly 1 hour booster/debriefing sessions. RESULTS: A total of 37 staff participated (RN = 18, MD = 5, Technician = 6, Social Worker = 3, Child life = 3, others = 2) in the initial training, and 24 (65%) completed the 3- and 12-month follow-up surveys. Compared with pretraining scores, there were significant improvements 3 to 12 months after the initial training in stress (P < .0001), distress (P ≤ .04), anxiety (P = .01), self-efficacy in providing non-drug therapies (P < .0001), mindfulness (P = .002), burnout (P < .0001), and confidence in providing compassionate care (P < .0001). In addition, 25 (67%) participants initiated projects incorporating what they learned into staff/patient wellness activities. CONCLUSION: This longitudinal pilot program was feasible and was associated with improvements in measures of psychological well-being over the 12-month intervention. The innovative approach of training participants to teach basic techniques to coworkers and other staff can increase the impact of this program beyond any individual participant. Future research will investigate the aspects of implementation and potential effects on patient care and experience.

Mindfulness-Based Stress Reduction and Group Support Decrease Stress in Adolescents with Cardiac Diagnoses: A Randomized Two-Group Study.

Adolescents with cardiac diagnoses face unique challenges that can cause psychosocial distress. This study compares a Mindfulness-Based Stress Reduction (MBSR) program to a video online support group for adolescents with cardiac diagnoses. MBSR is a structured psycho-educational program which includes yoga, meditation, cognitive restructuring, and group support. A published feasibility study by our group showed significant reduction in anxiety following this intervention. Participants were randomized to MBSR or video online support group, and completed measures of anxiety, depression, illness-related stress, and coping pre- and post-6-session interventions. Qualitative data were obtained from post-intervention interviews. A total of 46 teens participated (mean 14.8 years; 63% female). Participants had congenital heart disease and/or cardiac device (52%), or postural orthostatic tachycardia syndrome (48%). Illness-related stress significantly decreased in both groups. Greater use of coping skills predicted lower levels of depression in both groups post-study completion. Higher baseline anxiety/depression scores predicted improved anxiety/depression scores in both groups. Each group reported the benefits of social support. The MBSR group further expressed benefits of learning specific techniques, strategies, and skills that they applied in real-life situations to relieve distress. Both the MBSR intervention and video support group were effective in reducing distress in this sample. Qualitative data elucidated the added benefits of using MBSR techniques to manage stress and symptoms. The video group format is useful for teens that cannot meet in person but can benefit from group support. Psychosocial interventions with stress management techniques and/or group support can reduce distress in adolescents with cardiac diagnoses.

Intravenous Hydration for Management of Medication-Resistant Orthostatic Intolerance in the Adolescent and Young Adult.

Orthostatic intolerance (OI) is common in teenagers (T) and young adults (A). Despite treatment with oral fluids, medication, and exercise, a significant number have symptoms from multiple organ systems and suffer low quality of life (QOL). Previous studies showed that acute intravenous (IV) hydration (IH) could help restore orthostatic tolerance; however, no data are available about the intermediate-term effects of IH. We therefore studied the efficacy of IH to improve QOL and manage medication-refractory OI patients. Our study population consisted of 39 patients (mean age = 16.1 ± 3.3) years; thirty-two were female. Average number of medications failed = 3.1. Average QOL score on self-reported OI questionnaire was 4.2 (normal QOL = 10). IV hydration consisted of normal saline (1-2 l/day, 3-7 days/week). 1) Orthostatic testing revealed Postural Orthostatic Tachycardia (24), Neurally Mediated Hypotension (14) or OI (1). 2) Average orthostatic change in heart rate was 48 ± 18 bpm. 3) IH was performed via intermittent IV access (10), PICC line (22), and Port (7). 4) Duration of IH varied from 1 week to 3.8 years (mean = 29 ± 47 weeks). 5) Overall, 79 % (n = 31) demonstrated clinically improved self-reported QOL. 6) Six patients who discontinued IH requested to restart treatment. (7) Complications consisted of upper extremity deep vein thrombosis (n = 3) and infection (n = 4). IH is an effective therapy to improve QOL in T&A with medication-resistant OI. Most patients continued to report improved QOL once IH was discontinued. IH should be considered a therapeutic option in medication-resistant OI patients with low QOL.

A pilot study of a mindfulness based stress reduction program in adolescents with implantable cardioverter defibrillators or pacemakers.

Adolescents with implantable cardioverter defibrillators (ICDs) or pacemakers (PMs) face unique challenges that can cause psychosocial distress. Psychosocial interventions are effective for adults with cardiac devices and could potentially impact adolescents' adjustment to these devices. Mindfulness Based Stress Reduction (MBSR) is a structured psycho-educational program that includes meditation, yoga, and group support and has been studied extensively among adults. This study examined the feasibility of the MBSR program for adolescents with ICDs/PMs, a population previously unexamined in the research literature. The participants completed measures of anxiety and depression (Hospital Anxiety and Depression Scale) and coping (Responses to Stress Questionnaire) at baseline and after the six-session MBSR intervention. Mean age of the cohort (n = 10) was 15 ± 3 years, 6 were male, 6 had a PM, and 4 had an ICD. Feasibility was demonstrated by successful recruitment of 10 participants, 100 % participation and completion. Anxiety decreased significantly following the intervention, with a large effect size, t[9] = 3.67, p < .01, ŋ (2) = .59. Anxiety frequency decreased from baseline to post-intervention (Fisher's exact test p = .024), and 90 % of participants reported decreased anxiety scores post-intervention. Coping skills related negatively to anxiety (r = -.65, p = .04) and depression (r = -.88, p = .001). Post-intervention, the group independently formed their own Facebook group and requested to continue meeting monthly. Although generalizability is limited due to the small sample size, this successful pilot study paves the way for larger studies to examine the efficacy of MBSR interventions in adolescents with high-risk cardiac diagnoses.

Implant and clinical characteristics for pediatric and congenital heart patients in the national cardiovascular data registry implantable cardioverter defibrillator registry.

BACKGROUND: In 2010, the National Cardiovascular Data Registry enhanced pediatric, nonatherosclerotic structural heart disease and congenital heart disease (CHD) data collection. This report characterizes CHD and pediatric patients undergoing implantable cardioverter defibrillator implantation. METHODS AND RESULTS: In this article, we report implantable cardioverter defibrillator procedures (April 2010 to December 2012) in the registry for 2 cohorts: (1) all patients with CHD (atrial septal defect, ventricular septal defect, tetralogy of Fallot, Ebstein anomaly, transposition of the great vessels, and common ventricle) and (2) patients <21 years. We evaluated indications and characteristics to include transvenous and nontransvenous lead implants, CHD type, and New York Heart Association class. There were 3139 CHD procedures, 1601 for patients <21 years and 126 for CHD <21 years. Implantable cardioverter defibrillator indications for patients with CHD were primary prevention in 1943 (61.9%) and secondary prevention in 1107 (35.2%). Pediatric patients had 935 (58.4%) primary prevention and 588 (36.7%) secondary prevention devices. Primary prevention had higher New York Heart Association class. Nontransvenous age (35.9 ± 23.2 versus 40.1 ± 24.6 years; P=0.05) and nontransvenous height (167.1 ± 18.9 cm; range, 53-193 cm versus 170.4 ± 13.1 cm; range, 61-203 cm; P<0.01) were lower than for transvenous patients. CHD and pediatrics had similar rates of transvenous (97%) and nontransvenous (3%) leads and did not differ from the overall registry. Transposition of the great vessels and common ventricle had higher rates of nontransvenous leads. CONCLUSIONS: Primary prevention exceeds secondary prevention for CHD and pediatrics. Nontransvenous lead patients were younger, with higher rates of transposition of the great vessels and common ventricle patients compared with transvenous lead patients.

Multi-institutional study of implantable defibrillator lead performance in children and young adults: results of the Pediatric Lead Extractability and Survival Evaluation (PLEASE) study.

BACKGROUND: Implantable cardioverter-defibrillator (ICD) therapy in children and congenital heart disease patients is hampered by poor long-term lead survival. Lead extraction is technically difficult and carries substantial morbidity. We sought to determine the outcomes of ICD leads in pediatric and congenital heart disease patients. METHODS AND RESULTS: The Pediatric Lead Extractability and Survival Evaluation (PLEASE) is a 24-center international registry. Pediatric and congenital heart disease patients with ICD lead implantations from 2005 to 2010 were eligible. Study subjects comprised 878 ICD patients (44% congenital heart disease). Mean±SD age at implantation was 18.6±9.8 years. Of the 965 total leads, 54% were thin (≤7F), of which 57% were Fidelis, and 23% were coated with expanded polytetrafluoroethylene. There were 139 ICD lead failures (14%) in 132 patients (15%) at a mean lead age of 2.0±1.4 years, causing shocks in 53 patients (40%). Independent predictors of lead failure included younger implantation age and Fidelis leads. Actuarial analysis showed an incremental risk of lead failure with younger age at implantation: <8 years compared with >18 years (P=0.015). The actuarial yearly failure rate was 2.3% for non-Fidelis and 9.1% for Fidelis leads. Extraction was performed on 143 leads (80% thin, 7% expanded polytetrafluoroethylene coated), with lead age as the only independent predictor for advanced extraction techniques. There were 6 major extraction complications (4%) but no procedural mortality. CONCLUSIONS: This study demonstrates that ICD leads in children and congenital heart disease patients have an age-related suboptimal performance, further compounded by a high failure rate of Fidelis leads. Advanced extraction techniques were common and correlated with older lead age. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00335036.

Intra/extracardiac fenestrated modification leads to lower incidence of arrhythmias after the Fontan operation.

OBJECTIVE: The study objective was to compare the incidence of short- and intermediate-term arrhythmias among 3 different surgical modifications of the Fontan procedure. METHODS: We performed a retrospective review of all patients who underwent the Fontan operation at a single institution between January 2004 and May 2010 for preoperative, perioperative, and follow-up variables. Three surgical modifications were studied: intra/extracardiac conduit with limited atriotomy, standard extracardiac conduit, and lateral tunnel. Rhythm was classified as normal or abnormal. A rhythm dysfunction grading was devised and used to identify worsening of rhythm for patients with abnormal rhythm preoperatively. Multivariable logistic regression was used to determine predictors of abnormal rhythm. To eliminate confounding effects of transient immediate postoperative arrhythmias, data were analyzed for abnormal rhythm within the first 2 weeks and for more than 2 weeks after surgery. RESULTS: Of the 134 patients (n = 50 with intra/extracardiac conduit with limited atriotomy, n = 19 with standard extracardiac conduit, n = 65 with lateral tunnel) (median follow-up, 36 months; interquartile range, 22-50 months; 2 operative deaths and 6 late deaths), rhythm data for more than 2 weeks postoperatively were available in 88 (40 with lateral tunnel, 14 with standard extracardiac conduit, 34 with intra/extracardiac conduit with limited atriotomy). These patients constituted the study groups. Patients in the lateral tunnel group were relatively younger at the time of the Fontan operation (P < .001) and had a longer follow-up (P < .001). Multivariable logistic regression confirmed that greater than moderate atrioventricular valve regurgitation was the only independent predictor of abnormal rhythm during the first 2 postoperative weeks. Older age at Fontan (odds ratio, 1.20; 95% confidence interval, 1.05-1.38; P = .012) and higher preoperative mean pulmonary artery pressure (odds ratio, 1.2; 95% confidence interval, 1.03-1.44; P = .026) were predictors of abnormal rhythm more than 2 weeks postoperatively. Intra/extracardiac conduit with limited atriotomy Fontan modification was associated with a significantly lower incidence of abnormal rhythm after 2 weeks postoperatively compared with lateral tunnel modification (odds ratio, 0.28; 95% confidence interval, 0.10-0.84; P = .015). CONCLUSIONS: Intra/extracardiac conduit with limited atriotomy Fontan modification has a significantly lower risk of abnormal rhythm postoperatively in the short and intermediate term when compared with the lateral tunnel.

Anxiety and depression in implanted cardioverter-defibrillator recipients and heart failure: a review.

Although implanted cardioverter-defibrillators (ICDs) clearly reduce mortality, their effects on patients' psychological status is equivocal, with a substantial number of patients becoming depressed or anxious after ICD implantation. Significant numbers of ICD recipients, including those with heart failure (HF), remain anxious and depressed 1 year after ICD implantation. ICD recipients who are younger, female, and received ICD shocks are especially vulnerable to psychological distress. Screening for anxiety and depression is appropriate for all ICD recipients. Cognitive behavioral therapy and psychoeducational programs show promise for reducing psychological distress in ICD recipients with HF.

Dilated cardiomyopathy following right ventricular pacing for AV block in young patients: resolution after upgrading to biventricular pacing systems.

INTRODUCTION: Cardiac resynchronization therapy (CRT) has been demonstrated to result in clinical improvement in older adult patients with dilated cardiomyopathy (DCM), specifically those with left bundle branch block and prolonged QRS duration. We sought to demonstrate the benefits of CRT on improvement in cardiac function and clinical outcome in young patients that developed congestive heart failure (CHF) and DCM following cardiac pacing for AV block. METHODS AND RESULTS: We reviewed the charts of six patients who developed CHF or low cardiac output symptoms and DCM following implantation of right ventricular (RV)-based pacing systems for AV block, and subsequently underwent CRT. Patients ranged in age from 6 months to 23.7 years (mean: 11.3 +/- 3.6 years). AV block was congenital (3), post-surgery (2), and acquired (1). Pacing had been performed for 0.1-14.5 (7.6 +/- 2.4) years prior to development of DCM. Two patients required listing for cardiac transplantation. Following CRT: (1) QRS duration shortened from 204 +/- 15 to 138 +/- 10 msec, P = 0.002, (2) left ventricular ejection fraction improved from 34 +/- 6 to 60 +/- 2%, P = 0.003, and (3) left ventricular end diastolic dimension shortened from 5.5 +/- 0.8 to 4.3 +/- 0.5 cm, P = 0.03. All patients demonstrated clinical improvement and have been weaned from CHF medications and listing for cardiac transplantation. CONCLUSIONS: CRT can benefit young patients that develop CHF and DCM following RV pacing for AV block. Upgrading to biventricular pacing systems should be considered early in the management of these patients prior to listing for cardiac transplantation.

Effectiveness of excimer laser-assisted pacing and ICD lead extraction in children and young adults.

BACKGROUND: High capture thresholds, decreased electrical sensing, and lead fractures continue to be a problem in children undergoing transvenous pacing. The clinician must therefore decide at the time of pacing system revision to either abandon chronically implanted transvenous pacing leads or extract them. METHODS: We report our experience using an excimer laser-assisted (LA) strategy for removing chronically implanted pacing (36) and implantable cardioverter/defibrillator (ICD) (7) leads in children and young adults. The study population consisted of 25 patients, in whom 29 procedures were performed. The patients ranged in age from 8.4 to 39.9 years, median age was 13.9 years, at the time of the extraction procedure. In all procedures, a Spectranectics locking stylet and excimer laser sheath were used to assist in lead extraction. RESULTS: Lead removal was complete for 39 (91%) leads, and partial for four leads. In two patients, the pacing lead tip was retained and in two, the ring electrode from a bipolar pacing lead was left in situ. All ICD leads were removed completely. Two major complications occurred--cardiac perforation and tamponade (1), and thrombosis of the left subclavian/innominate vein (1). LA extraction facilitated the implantation of new pacing or ICD leads in three patients with obstructed venous access. CONCLUSIONS: Removal of pacing and ICD leads using an excimer LA technique was highly successful. Lead removal was complete in 91%. The most common indication for lead removal in our study was lead fracture. Complications were few, but may be significant.