Heart Rhythm New Zealand consensus statement on the practical management of cardiac implanted electronic devices in the peri-operative environment.

Electrosurgery is commonly used during a range of operations in order to maintain effective haemostasis. This can cause electromagnetic interference (EMI) with cardiac implanted electronic devices (CIEDs), which prevents normal device function. CIEDs include pacemakers (PPM), implantable cardiac defibrillators (ICD), cardiac resynchronisation therapy devices-both pacemakers and defibrillators (CRT-P/CRT-D)-and implantable loop recorders (ILRs). Damage to the generator, inhibition of pacing, activation of asynchronous pacing and ventricular fibrillation can all be induced by electrocautery. An active management plan for CIEDs during electrosurgery is critical to minimise these adverse effects of EMI. Purpose: To facilitate the safe and effective peri-operative management of CIED patients during electrosurgery.

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.

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.

Final results from the ribavirin pregnancy registry, 2004-2020.

INTRODUCTION: Significant teratogenic effects have been demonstrated for ribavirin in animal studies. Ribavirin is prescribed for chronic hepatitis C and is contraindicated in pregnant women and their male sexual partners. Both are advised to avoid pregnancy for 6 months after exposure. The registry monitored pregnancy exposures to oral formulations of ribavirin for hepatitis C for signals of possible human teratogenicity from 2004 to 2020. METHODS: Pregnant women were voluntarily enrolled following direct exposure (ribavirin use during pregnancy or the 6 months prior) or indirect exposure (through sexual contact during pregnancy or 6 months prior, with a man who has taken ribavirin within 6 months). Women were followed until the end of pregnancy. Infants were followed until 1 year of age. Birth defect rates were compared with the published rate of 2.67 per 100 live births from the Metropolitan Atlanta Congenital Defects Program (MACDP). RESULTS: The registry enrolled 280 pregnancies resulting in 186 live births: eight birth defect cases among 88 directly exposed [9.09% (8/88, 95% CI: 4.01, 17.13)], and six birth defect cases among 98 indirectly exposed [6.12% (6/98, 95% CI: 2.28, 12.85)]. The 95% CI around the birth defect rate among directly exposed pregnancies exceeds the MACDP rate; however, no patterns suggestive of a teratogenic mechanism or safety signal were detected. CONCLUSION: Based on the patterns of birth defects reported, the final results from this registry do not suggest a clear signal of human teratogenicity for ribavirin. The registry did not meet sample size requirements; therefore, caution should be exercised when interpreting the results.

An Innovative Online Qualitative Study to Explore the Symptom Experience of Patients with Primary Sjögren's Syndrome.

INTRODUCTION: Primary Sjögren's syndrome (pSS) is a complex, heterogenous autoimmune disease; no immunomodulatory drug has demonstrated efficacy, and no current treatments target the underlying cause. This study aimed to explore the disease and treatment experiences of patients with pSS. METHODS: This qualitative study (208399) comprised moderated online forum discussions and online one-to-one questions conducted in the USA over a 2-week period. Participants were self-reported patients with pSS; physician confirmation of diagnosis was sought. Participants described disease and symptom severity and satisfaction with current pSS treatments. Qualitative data analysis was performed using inductive coding analysis via open coding. RESULTS: Fifty-two participants entered the study, of whom 48 provided analysable data. Symptoms were described as highly unpredictable and variable, with fatigue rated as the most severe and burdensome. Participants discussed how their pSS symptoms and the frequent need for regular treatment impacted their daily activities, social life, career and finances. Many participants perceived a poor understanding of pSS amongst physicians, leading to emotional distress and difficulties obtaining a diagnosis. All participants stated that an ideal medication would address the cause of pSS and not just treat symptoms. CONCLUSION: New insights into patients' perspectives of pSS were generated from online discussion forums, revealing the additional impact of unpredictable symptoms and multiple symptomatic treatments to the high disease burden. Improving physician education of pSS may help to alleviate frustrations and delays associated with diagnosis; the advent of novel effective treatments would be welcomed by patients with pSS.

Completeness of ANZACS-QI Cardiac Implanted DEVICE Registry and agreement with national datasets: ANZACS-QI 30.

AIMS: The ANZACS-QI Cardiac Implanted Device Registry (ANZACS-QI DEVICE) collects data on cardiac implantable electronic devices inserted in New Zealand. We evaluated completeness of data capture and quality of ANZACS-QI DEVICE in 2016. METHODS: Complete datasets within ANZACS-QI DEVICE, comprising DEVICE-PPM (permanent pacemakers) and DEVICE-ICD (implantable cardioverter defibrillators), from 1 January 2016 to 31 December 2016 were linked with the National Hospitalisation dataset (all New Zealand public hospital admissions). The total number of implants included procedures captured in either dataset. Variables assessed included age, gender, ethnicity, procedure type, implanting centre, admission and procedure date. RESULTS: DEVICE-PPM captured 85.9% of all PPM procedures (n=2,512). This was similar regardless of age, sex and ethnicity. In the 84.4% of procedures captured in both datasets, agreement was >97% for all variables except admission date (90.1%). DEVICE-ICD captured 81.3% of all ICD procedures (n=690). Capture was similar across age, sex and ethnicity groups. In the 76.8% of procedures captured in both datasets, agreement was >96% for all variables except admission date (90.6%). CONCLUSION: The ANZACS-QI DEVICE registry had a good capture rate and excellent agreement with the national dataset. This high concordance supports the use of both datasets for future research.

Change in total sugars consumption among Canadian children and adults.

BACKGROUND: Free sugars are nutrients of public health concern that have been associated with negative health outcomes, including dental caries in children and excess weight gain. Since national-level free sugars data are not currently available for Canadians, total sugars intake was examined to understand sugars intake in the population. The objective of this analysis was to describe and compare total sugars consumption among Canadians in 2004 and 2015. DATA AND METHODS: Data are from the 2004 and 2015 Canadian Community Health Survey-Nutrition. Separate descriptive analyses of total sugars for children aged 2 to 18 (n=13,919) and adults aged 19 and older (n=31,156) were conducted by year and by misreporting status (under-, plausible and over-reporters), and the top sources of total sugars were identified. Misreporting status was studied to better understand differences in sugars intakes between survey years. T-tests were used to determine significant differences between survey years. RESULTS: In 2015, the average daily total sugars consumption was 101 grams (24 teaspoons) for children aged 1 to 8, 115 grams (27 teaspoons) for children aged 9 to 18, and 85 grams (20 teaspoons) for adults. Sugary beverages, taken together, were the top source of sugars for all age groups. Total sugars consumption decreased from 2004 to 2015 overall, although not by misreporting status. Total sugars from food alone increased from 2004 to 2015, and total sugars from beverages alone decreased, regardless of age or misreporting status. DISCUSSION: The overall decrease in total sugars consumption from 2004 to 2015 may be explained by changes in misreporting. Total sugars from food alone increased, while total sugars from beverages alone decreased. This was true for all age groups and for plausible reporters.

Nurses best practices for the management of thrombotic thrombocytopenic purpura.

A group of Canadian apheresis nurses developed best practice for in the management of thrombotic thrombocytopenic purpura (TTP). The recommendations address issues related to infusion protocols, preventing and managing adverse events, comprehensive patient assessments, treatment procedures, as well as pre- and post- treatment care. The Canadian group encourages institutes to include nurses on committees that examine recommendations for TTP management.

The Ribavirin Pregnancy Registry: An Interim Analysis of Potential Teratogenicity at the Mid-Point of Enrollment.

INTRODUCTION: Significant teratogenic effects have been demonstrated in all animal species exposed to ribavirin. Ribavirin is prescribed for chronic hepatitis C and is contraindicated in women who are pregnant and in the male sexual partners of women who are pregnant. Both sexes are advised to avoid pregnancy for 6 months after exposure. The Ribavirin Pregnancy Registry was established in 2003 to monitor pregnancy exposures to ribavirin for signals of possible human teratogenicity. METHODS: This voluntary registry enrolls pregnant women with prenatal exposure to ribavirin. Exposure is classified as direct-women taking ribavirin during pregnancy or the 6 months prior to conception-or indirect-women exposed through sexual contact, 6 months prior to or during pregnancy, with a man who is taking or has taken ribavirin in the past 6 months. Women are followed until delivery and infants for 1 year. When enrollment is complete, birth defect rates will be compared with the Metropolitan Atlanta Congenital Defects Program's published rate of 2.67. Using data collected since inception in 2003 through February 2016, preliminary rates were calculated. RESULTS: The registry has enrolled 272 pregnant women, with 180 live births: there were seven birth defect cases among 85 directly exposed women [7/85 (8.2%) (95% confidence interval (CI) 3.4-16.2)] and four birth defect cases among 95 indirectly exposed women [4/95 (4.2%) (95% CI 1.2-10.4)]. Of the 11 infants, nine had structural defects and two had chromosomal anomalies. Patterns suggesting a common etiology or relationship with ribavirin exposure are not seen. CONCLUSION: Based on the patterns of birth defects reported, preliminary findings do not suggest a clear signal of human teratogenicity for ribavirin. However, the current sample size is insufficient for definitive conclusions, and ribavirin exposure should be avoided during pregnancy and during the 6 months prior to pregnancy, in accordance with prescribing information. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT00114712.

Medication Safety During Pregnancy: Improving Evidence-Based Practice.

Nearly 90% of women in the United States have taken medications during pregnancy. Medication exposures during pregnancy can result in adverse pregnancy and neonatal outcomes including birth defects, fetal loss, intrauterine growth restriction, prematurity, and longer-term neurodevelopmental outcomes. Advising pregnant women about the safety of medication use during pregnancy is complicated by a lack of data necessary to engage the woman in an informed discussion. Routinely, health care providers turn to the package insert, yet this information can be incomplete and can be based entirely on animal studies. Often, adequate safety data are not available. In a busy clinical setting, health care providers need to be able to quickly locate the most up-to-date information in order to counsel pregnant women concerned about medication exposure. Deciding where to locate the best available information is difficult, particularly when the needed information does not exist. Pregnancy registries are initiated to obtain more data about the safety of specific medication exposures during pregnancy; however, these studies are slow to produce meaningful information, and when they do, the information may not be readily available in a published form. Health care providers have valuable data in their everyday practice that can expand the knowledge base about medication safety during pregnancy. This review aims to discuss the limitations of the package insert regarding medication safety during pregnancy, highlight additional resources available to health care providers to inform practice, and communicate the importance of pregnancy registries for expanding knowledge about medication safety during pregnancy.

Advantages and problems with pregnancy registries: observations and surprises throughout the life of the International Lamotrigine Pregnancy Registry.

PURPOSE: The International Lamotrigine Pregnancy Registry monitored for a signal of a substantial increase in the frequency of major congenital malformations associated with lamotrigine exposures in pregnancy over an 18-year period. Key methodological lessons are discussed. METHODS: The strengths and weaknesses of the Registry were assessed using quantifiable methodological and operational parameters including enrollment, completeness of exposure and outcome data reporting, and lost to follow-up. The choice of comparator groups and stopping rules for registry closure were critically evaluated. RESULTS: The reliance on voluntary reporting was associated with a clustered geographical distribution of registered pregnancies. The enrollment rate increased over time with new approvals and indications for lamotrigine and publication of interim data. Reporter burden was minimized through a streamlined data collection approach resulting in a high level of completeness of exposure and primary outcome data. Lost to follow-up rates were high (28.5% overall) representing a major limitation; incentives to increase the completeness of reporting failed to reduce rates. A lack of an internal comparator group complicated data interpretation; but external comparisons with multiple external groups allowed an assessment of consistency of outcome data across multiple data sources. A lack of a priori closure criteria prolonged the life of the Registry, and consideration of regulatory guidelines on this subject is encouraged at the time of conception of future registries. CONCLUSIONS: A successful pregnancy exposure registry requires ongoing flexibility and continuous re-assessment of enrollment, recruitment, and retention methods and the availability of comparison data, throughout its lifecycle.

The influence of menu labeling on calories selected or consumed: a systematic review and meta-analysis.

Recent menu labeling initiatives in North America involve posting the calorie content of standard menu items, sometimes with other nutrients of public health concern, with or without contextual information (such as the recommended daily caloric intake for an average adult) or interpretive information (such as traffic light symbols). It is not clear whether this is an effective method to convey nutrition information to consumers wanting to make more-informed food choices. Of particular concern are those consumers who may be limited in their food and health literacy skills to make informed food choices to meet their dietary needs or goals. The purpose of this systematic review was to determine whether the provision of menu-based nutrition information affects the selection and consumption of calories in restaurants and other foodservice establishments. A secondary objective was to determine whether the format of the nutrition information (informative vs contextual or interpretive) influences calorie selection or consumption. Several bibliographic databases were searched for experimental or quasiexperimental studies that tested the effect of providing nutrition information in a restaurant or other foodservice setting on calories selected or consumed. Studies that recruited generally healthy, noninstitutionalized adolescents or adults were included. When two or more studies reported similar outcomes and sufficient data were available, meta-analysis was performed. Menu labeling with calories alone did not have the intended effect of decreasing calories selected or consumed (-31 kcal [P=0.35] and -13 kcal [P=0.61], respectively). The addition of contextual or interpretive nutrition information on menus appeared to assist consumers in the selection and consumption of fewer calories (-67 kcal [P=0.008] and -81 kcal [P=0.007], respectively). Sex influenced the effect of menu labeling on selection and consumption of calories, with women using the information to select and consume fewer calories. The findings of this review support the inclusion of contextual or interpretive nutrition information with calories on restaurant menus to help consumers select and consume fewer calories when eating outside the home. Further exploration is needed to determine the optimal approach for providing this menu-based nutrition information, particularly for those consumers who may be limited in their food and health literacy skills.

Final results from the 16-year sumatriptan, naratriptan, and treximet pregnancy registry.

OBJECTIVES: To monitor for a signal of major teratogenicity by determining the risk of all birth major defects following in utero exposure to sumatriptan, naratriptan, and the sumatriptan/naproxen sodium combination product (tablets marketed in the United States as Treximet [GlaxoSmithKline, Research Triangle Park, NC, USA]), and to monitor for unusual patterns of defects that might suggest teratogenicity. BACKGROUND: The prevalence of migraine is highest in women of childbearing age. Coupled with the recurrent nature of migraine attacks and the high proportion of unplanned pregnancies, intentional and inadvertent exposure to anti-migraine drugs in pregnancy is likely. The Sumatriptan, Naratriptan, and Treximet Pregnancy Registry captured data on women exposed to those drugs during pregnancy to monitor for evidence of major teratogenicity. METHODS: In this primarily prospective, observational study, health care professionals from anywhere in the world enrolled, on a voluntary basis, women exposed to sumatriptan, naratriptan, or the sumatriptan/naproxen sodium combination product during their pregnancies. Only pregnancies with unknown outcomes at the time of enrollment were included in the analysis. The proportion of infants or fetuses with major birth defects was calculated as the total number of infants/fetuses with major birth defects divided by the sum of the number of infants/fetuses with major birth defects + the number of live births without defects. The risk of major birth defects was further stratified by earliest trimester of pregnancy exposure. RESULTS: The registry enrolled 680 evaluable exposed pregnant women, which resulted in 689 infants and fetuses (outcomes). Of these outcomes, 626 were exposed to sumatriptan, 57 were exposed to naratriptan (seven were exposed to both sumatriptan and naratriptan), and six were exposed to the sumatriptan/naproxen sodium combination product. Twenty outcomes with major birth defects were reported among 528 outcomes exposed in the first trimester to sumatriptan. The estimated risk of major birth defects following first-trimester sumatriptan exposure is 4.2% (20/478 [95% confidence interval [CI] 2.6%-6.5%]). Among 52 first-trimester exposures to naratriptan, major birth defects were reported in one outcome, an infant with exposure to both sumatriptan and naratriptan [birth defect risk of 2.2% (1/46 [95% CI 0.1%-13.0%]). No major defects were reported among the five outcomes with first-trimester exposure to the sumatriptan/naproxen sodium combination products. CONCLUSIONS: The Sumatriptan, Naratriptan, and Treximet Pregnancy Registry detected no signal of teratogenicity associated with major birth defects for sumatriptan. This finding is consistent with results from other observational studies using a variety of control groups. Enrollment in the registry was insufficient to permit definitive conclusions of the risks associated with naratriptan or sumatriptan/naproxen sodium tablets, or to assess the risk of individual birth defects in any of the products studied. Low enrollment and high rates of loss to follow up within the registry over an extended period of time led the registry's scientific advisory committee to conclude that continuation of the registry beyond its 16 years would offer little additional power to rule out more moderate increases in the risk of birth defects. Data from the other ongoing surveillance sources constitute an important element of post-marketing surveillance of these medications. The lack of a signal of major teratogenicity with sumatriptan across these several sources of data is encouraging.

The Green Lane and Auckland City Hospital cardiac resynchronisation therapy experience.

AIM: To evaluate the outcome of cardiac resynchronisation therapy (CRT) in Auckland since its inception in 2000. Outcome measures were periprocedural events including procedure duration, fluoroscopic time, procedure success, complications, and echocardiographic markers of response. METHODS: Retrospective review of those undergoing CRT implantation at Green Lane and Auckland City Hospitals. RESULTS: 159 CRT procedures were performed on 139 patients between 2000 and April 2011. Of all procedures: 63% had new device implants, and 23% were upgraded from a pacemaker or defibrillator to CRT. Mean age 62 years, 77% male, mean left ventricular ejection fraction (LVEF) 25%, mean QRS duration 175 ms, 91% LBBB, 36% ischaemic cardiomyopathy. Mean procedure time 147 min and fluoroscopy time 30 min. Eight patients had significant periprocedural complications (6%), 17 experienced lead displacement (12%), and 15 (11%) had unsuccessful procedures. 46% of patients had complete echocardiographic data, of these LVEF improved by >5% in 52%, and decreased by >5% in 6% over a 16-month follow-up. CONCLUSIONS: Our service performs well with respect to complication rate, though less well when failure of implantation and lead dislodgement are considered. Where complete echocardiographic data was present 52% of our patients derived significant improvement in LVEF.

Emergency cardiac resynchronisation in a 4kg infant post surgical closure of ventricular septal defect.

Cardiac resynchronisation therapy (CRT) is an established treatment for adult patients with cardiac failure due to mechanical and electrical dyssynchrony. Data on CRT in infants are scarce. We report the remarkable success of emergent CRT by epicardial pacing of the left ventricular apex in a 4kg infant with left ventricular failure due to LV dyssynchrony from left bundle branch block.