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Summary: Idecabtagene vicleucel (ide‐cel), a chimeric antigen receptor T‐cell therapy targeting B‐cell maturation antigen (BCMA), received early access program (EAP) authorization in France in April 2021 for relapsed/refractory multiple myeloma (RRMM). We conducted a real‐world registry‐based multicentre observational study in 11 French hospitals to evaluate ide‐cel outcomes. Data from 176 RRMM patients who underwent apheresis between June 2021 and November 2022 were collected from the French national DESCAR‐T registry. Of these, 159 patients (90%) received ide‐cel. Cytokine release syndrome occurred in 90% with 2% grade ≥3, and neurotoxicity occurred in 12% with 3% grade ≥3. Over the first 6 months, the best overall response and ≥complete response rates were 88% and 47% respectively. The median progression‐free survival (PFS) from the ide‐cel infusion was 12.5 months, the median overall survival (OS) was 20.8 months and the estimated OS rate at 12 months was 73.3%. Patients with extra‐medullary disease (EMD) had impaired PFS (6.2 months vs. 14.8 months). On multivariable analysis, EMD and previous exposure to BCMA‐targeted immunoconjugate or T‐cell‐redirecting GPRC5D bispecific antibody were associated with inferior PFS. Our study supports ide‐cel's feasibility, safety and efficacy in real‐life settings, emphasizing the importance of screening for EMD and considering prior treatments to optimize patient selection. [ABSTRACT FROM AUTHOR]

Goals Of Work: Treatments for early-stage prostate cancer (PCa) are highly effective; therefore, research studies that explore quality of life (QOL) issues associated with different treatments are important. The purposes of this study were to (a) examine differences among treatment groups of men treated with either radiation therapies or radical prostatectomy for PCa and (b) examine quality of life outcomes over time.Patients and Methods: We report outcomes 6 and 12 months after 159 men began treatment for PCa with either one of two types of radiation treatment (intensity-modulated radiation therapy plus high dose rate or intensity-modulated radiation therapy plus seed implantation) or radical prostatectomy.Main Results: Significant differences among groups are described. Significant predictors of QOL at 6 months included urinary, bowel, and sexual symptoms, anxiety, depression, problem-focused coping, and physiological self-efficacy. Significant predictors of QOL at 12 months were urinary and bowel symptoms, stress, depression, problem-focused coping, and physiological self-efficacy. Demographic variables, race, and living status were significant predictors of quality of life at 12 months.Conclusions: Physiological symptoms and psychological symptoms were both significant predictors of QOL. The psychological factors that predicted quality of life in this study have potential for intervention and point to the next stage of the research. [ABSTRACT FROM AUTHOR]

Pain management is essential for patients requiring high dose rate (HDR) brachytherapy due to required immobility and supine positioning as well as invasive equipment (HDR catheters) sutured to the perineum to administer the radiation into the prostate. The use of patient controlled epidural analgesia for the management of pain associated with HDR radiation therapy for prostate cancer appears to be more effective than peripheral patient controlled analgesea, and is considered a 'best practice' for effective pain management resulting in positive patient outcomes. [ABSTRACT FROM AUTHOR]

Urolithiasis (urinary tract calculi or stones) and nephrolithiasis (kidney calculi or stones) are well-documented common occurrences in the general population of the United States. The etiology of this disorder is mutifactorial and is strongly related to dietary lifestyle habits or practices. Proper management of calculi that occur along the urinary tract includes investigation into causative factors in an effort to pre-vent recurrences. Urinary calculi or stones are the most common cause of acute ureteral obstruction. Approximately 1 in 1,000 adults in the United States are hospitalized annually for treatment of urinary tract stones, resulting in medical costs of approximately $2 billion per year (Ramello, Vitale, & Marangella, 2000; Tanagho & McAninch, 2004). [ABSTRACT FROM AUTHOR]

Radiation oncology nurses must be adequately educated on the care and management of patients and families undergoing high-dose rate brachytherapy for early-stage prostate cancer. The application of advanced assessment skills, while incorporating the treatment aspects of radiation, provides a framework for standards of nursing practice in this field. Current methodologies of radiation therapy are recommended for overall professional growth and improvement of patient care. [ABSTRACT FROM AUTHOR]

Amyloidosis is a rare multisystem disorder characterized by extracellular accumulation of insoluble fibrils in various organs and tissues. The most common subtype in the pediatric population is systemic reactive amyloidosis, typically developing secondary to chronic inflammatory conditions and resulting in deposition of serum amyloid A protein in association with apolipoprotein HDL3. Clinical presentation is highly variable and is mostly influenced by specific organs involved, precursor protein type, and extent of amyloid deposition, often closely reflecting clinical features of the underlying disease. The most critical determinants of prognosis are cardiac and renal involvement. Diagnosis of amyloidosis is confirmed by tissue biopsy, which remains the gold standard, followed by precise amyloid fibril typing. The primary therapeutic approach is directed towards controlling underlying disease and reducing serum levels of precursor proteins to prevent further amyloid deposition. This study aims to highlight the main clinical characteristics of amyloidosis with onset in childhood, emphasizing the key differences compared to adult form.

Neonatal diabetes mellitus is a rare disorder of glucose metabolism with onset within the first 6 months of life. The initial treatment is based on insulin infusion. The technologies for diabetes treatment can be very helpful, even if guidelines are still lacking. The current study aimed to provide a comprehensive review of the literature about the safety and efficacy of insulin treatment with technology for diabetes to support clinicians in the management of infants with neonatal diabetes mellitus. A total of 22 papers were included, most of them case reports or case series. The first infants with neonatal diabetes mellitus treated with insulin pumps were described nearly two decades ago. Over the years, continuous glucose monitoring systems were added to treat these individuals, allowing for a better customization of insulin administration. Insulin was diluted in some cases to further minimize the doses. Improvement in technology for diabetes prompted clinicians to use new devices and algorithms for insulin delivery in infants with neonatal diabetes as well. These systems are safe and effective, may shorten hospital stay, and help clinicians weaning insulin during the remission phase in the transient forms or switching from insulin to sulfonylurea when suggested by the molecular diagnosis. New technologies for insulin delivery in infants with neonatal diabetes can be used safely and closed-loop algorithms can work properly in these situations, optimizing blood glucose control., (© 2024. The Author(s).)

Community-based policy, systems, and environmental interventions have the potential to reduce modifiable risk factors for obesity early in life. The purpose of this scoping review was to characterize the breadth, generalizability, and methodological quality of community-based diet and obesity-related policy, system, and environmental interventions during the first 1000 days of life, from pregnancy to 24 months of age. Eight databases were searched, and 83 studies (122 references) were included. Data were extracted for breadth (intervention characteristics), generalizability (reach, effectiveness, adoption, implementation, and maintenance), and study quality (Downs and Black Checklist). Systems and environmental approaches were common (> 80%), relative to policy approaches (39%). The majority (60-69%) occurred in the prenatal period and early infancy (0-3 months), assessed breastfeeding or child growth/obesity (53% for both), and included people with lower income (80%) or racial and/or ethnic minority groups (63%). Many interventions reported positive outcomes (i.e., in the expected direction) for child diet, breastfeeding, and feeding practices (> 62%). Few reported intervention maintenance or spanned the full 1000 days. Most studies were classified as good (32%) or fair (56%) methodological quality. The interventions mainly addressed pregnancy and early infancy. Rigorous and representative investigation is needed to improve intervention reach, sustainability, and application in toddlerhood., (© 2024 The Author(s). Obesity Reviews published by John Wiley & Sons Ltd on behalf of World Obesity Federation.)

Introduction: The dST-Tiso is a newly proposed electrocardiographic (ECG) marker during Brugada (BrS) type I pattern, that predicts the likelihood of ventricular arrhythmia (VA) inducibility in patients with ajmaline-induced pattern. The objective of this study was to validate the effectiveness of this criterion using an independent data set., Methods: Consecutive patients exhibiting a BrS type I ECG pattern following ajmaline administration underwent programmed ventricular stimulation (PVS). dST-Tiso interval was measured in all patients and tested as a predictor for positive VA inducibility., Results: Among 128 patients (median age 43 years, 59% male) with drug-induced BrS type I ECG pattern who underwent PVS, 32 (25.0%) had VA inducibility that required defibrillation. Compared to noninducible subjects, those with positive PVS were more commonly male (81% vs. 51%, p = 0.003), had longer PQ (165 vs. 160 ms, p = 0.016) and dST-Tiso (310 vs. 230 ms, p < 0.001) intervals, and shorter QT interval (412 vs. 420 ms, p = 0.022). When treated as a continuous variable, dST-Tiso confirmed significant association with VA inducibility, with an adjusted odds ratio of 1.02 (95% confidence interval: 1.01-1.03, p < 0.001) for each 1 ms increase in duration. A dST-Tiso interval >300 ms yielded a sensitivity of 75%, a specificity of 86%, and positive and negative predictive values of 69% and 91%, respectively., Conclusion: The validation of the model based on the dST-Tiso interval >300 ms confirmed its high accuracy in predicting VA inducibility in drug-induced BrS type I pattern. This straightforward ECG marker might be linked to the extent of the electrical substrate of the disease., (© 2024 Wiley Periodicals LLC.)

Background: Despite the high success rate of radiofrequency catheter ablation (RFCA) in Wolff-Parkinson-White Syndrome (WPW), localizing the successful ablation site can be challenging and may require multiple radiofrequency (RF) applications., Objective: This study aims to evaluate the efficacy of a novel workflow for the automatic and precise identification of accessory pathway ablation site, named Delta Wave Automatic Mapping., Methods: Patients undergoing a first procedure for RF ablation of a manifest accessory pathway were included. Electro-Anatomical Mapping (EAM) was performed with the CARTO 3 system (Biosense Webster, Johnson & Johnson Medical S.p.a., Irvine, CA) leveraging auto-acquisition algorithms already present in the CARTO 3 software. Mapping and ablation were performed with an irrigated tip catheter with contact force sensor. Procedure success was defined as loss of pathway function after ablation. The number of RF applications required and time to effect were measured for each patient. Recurrences were evaluated during follow-up visits. Additionally, at the end of each procedure, historical predictors of ablation success were measured offline to evaluate their relationship with the successful ablation site found with the novel workflow., Results: A total of 50 patients were analysed (62% APs right and 38% APs left). All 50 APs were successfully eliminated in each procedure with a median Time-to-effect (TTE) of 2.0 (IQR 1.2-3.5) seconds. No AP recurrences during a median follow-up of 10 (IQR 6-13) months were recorded. Offline analysis of successful ablation site revealed a pre-ablation delta/ventricular interval of ≤-10 msec in 52% of the patients and in 100% of the patients the signal related to the Kent bundle was identified., Conclusions: The novel workflow efficiently localizes APs without requiring manual annotations. Historical endocardial parameters predicting success were measured offline for each case and they corresponded to the ablation target automatically annotated by the proposed workflow. This novel mapping workflow holds promise in enhancing the efficacy of RFCA in the presence of manifest APs., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The author(s) declared that they were an editorial board member of Frontiers, at the time of submission. This had no impact on the peer review process and the final decision., (© 2024 Iacopino, Fabiano, Sorrenti, Petretta, Colella, Vilio, Statuto, Diomede, Artale, Filannino, Pardeo, Placentino, Campagna, Peluso, Cecchini, Cecchini, Speziale and Gaita.)

Introduction: Patients with Brugada syndrome (BrS) face an increased risk of ventricular arrhythmias and sudden cardiac death. Implantable cardiac monitors (ICMs) have emerged as effective tools for detecting arrhythmias in BrS. Technological advancements, including temperature sensors and improved subcutaneous electrocardiogram (subECG) signal quality, hold promise for further enhancing their utility in this population., Methods and Results: We present a case of a 40-year-old man exhibiting a BrS type 2 pattern on 12-lead ECG, who underwent ICM insertion (BIOMONITOR IIIm, BIOTRONIK) due to drug-induced BrS type 1 pattern and a history of syncope, with a negative response to programmed ventricular stimulation. The device contains an integrated temperature sensor and can transmit daily vital data, such as mean heart rate and physical activity. Several months later, remote alerts indicated a temperature increase, along with transmitted subECGs suggesting a fever-induced BrS type 1 pattern. The patient was promptly advised to commence antipyretic therapy. Over the following days, remotely monitored parameters showed decreases in mean temperature, physical activity, and mean heart rate, without further recurrence of abnormal subECGs., Conclusion: ICMs offer valuable insights beyond arrhythmia detection in BrS. Early detection of fever using embedded temperature sensors may improve patient management, while continuous subECG morphological analysis has the potential to enhance risk stratification in BrS patients., (© 2024 Wiley Periodicals LLC.)

Objectives: The authors report their experience of a protocol for deep sedation with ketamine in spontaneous respiration during the pulsed-field ablation (PFA) of atrial fibrillation (AF)., Design: Observational, prospective, nonrandomized fashion., Setting: Single-center hospitalized patients., Participants: All consecutive patients undergoing PFA of AF., Interventions: Patients undergoing deep sedation with intravenous ketamine., Measurements and Main Results: The authors' sedation protocol involves the intravenous administration of fentanyl (1.5 µg/kg) and midazolam (2 mg) at low doses before local anesthesia with lidocaine. A ketamine adjunct (1 mg/kg) in 5-minute boluses was injected about 5 minutes before the first PFA delivery. The authors enrolled 117 patients (age = 59 ± 10 y, 74.4% males, body mass index = 27.6 ± 5 kg/m 2 , fluoroscopy time = 24 ± 14 minutes, skin-to-skin time = 80 ± 40 minutes and PFA LA dwell time = 24 ± 7 minutes). By the end of the procedure, pulmonary vein isolation had been achieved in all patients using PFA alone. The mean time under sedation was 54.9 ± 6 minutes, with 92 patients (79%) being sedated for <1 hour. A satisfactory Ramsay Sedation Scale level before ketamine administration was achieved in all patients, except one (80.3% of the patients with rank 3; 18.4% with rank 2). In all procedures, the satisfaction level was found acceptable by both the patient and the primary operator (satisfactory in 98.2% of cases). All patients achieved a Numeric Rating Scale for Pain ≤3 (none or mild). No major procedure or anesthesia-related complications were reported., Conclusion: The authors' standardized sedation protocol with the administration of drugs with rapid onset and pharmacologic offset at low doses was safe and effective, with an optimal degree of patient and operator satisfaction., Competing Interests: Declaration of Competing Interest M. Malacrida is an employee of Boston Scientific. The other authors have no conflicts of interest to declare that they are relevant to the content of this article., (Copyright © 2023 Elsevier Inc. All rights reserved.)

Purpose: A new cryoballoon (CB) technology (POLARx™; Boston Scientific) for pulmonary vein (PV) isolation in patients with atrial fibrillation (AF) has recently been introduced. The aim of this study was to evaluate procedural and biophysical parameters resulting in acute PV isolation when using this new CB., Methods: We assessed the first 69 consecutive patients indicated for AF ablation who underwent PV isolation by means of a novel CB system. Procedural metrics were prospectively recorded., Results: A total of 274 PVs were targeted in 69 patients. PV isolation was achieved in all patients by means of cryoablation alone. The median time to isolation (TTI) was 44 [31-68] s (median temperature at TTI =  - 49 [- 53 to - 41] °C). The median duration of CB ablation was 180 [180 to 240] s. The median nadir temperature was - 56.0 [- 61 to - 52] °C, and the median thaw time to 0 °C was 18 [15-21] s. The median grade of PV occlusion was 4 [3 to 4]. On the basis of ROC analysis, we defined the following cut-off values for acute PV isolation: - 56 °C for nadir temperature (sensitivity = 73.3%, specificity = 64.6%, AUC = 0.716; positive predictive value = 88.1%), 30 s for TTT (60.2%, 53.3%, 0.578; 79.7%), thaw time > 17 s (65.3%, 70.0%, 0.709; 86.9%), and grade of PV occlusion = 4 (79.4%, 66.7%, 0.738; 88.5%). No major procedure-related adverse events were observed at 30-day post-procedure., Conclusions: The new POLARx™ CB appears to be effective and safe. A nadir temperature of - 56 °C, a thaw time to 0 °C ≥ 17 s, and complete PV occlusion were the best predictors of acute PV isolation., Clinical Trial Registration: Catheter Ablation of Arrhythmias with a High-Density Mapping System in Real-World Practice (CHARISMA). URL: http://clinicaltrials.gov/Identifier : NCT03793998. Registration date: January 4, 2019., (© 2021. Springer Science+Business Media, LLC, part of Springer Nature.)

The 4S-AF scheme [Stroke risk, Symptom severity, Severity of atrial fibrillation (AF) burden, Substrate severity] was recently proposed to characterize AF patients. In this post hoc analysis we evaluated the agreement between the therapeutic strategy (rate or rhythm control, respectively), as suggested by the 4S-AF scheme, and the actual strategy followed in a patients cohort. Outcomes of interest were as follows: all-cause death, a composite of all-cause death/any thromboembolism/acute coronary syndrome, and a composite of all-cause death, any thrombotic/ischemic event, and major bleeding (net clinical outcome). We enrolled 615 patients: 60.5% male, median age 74 [interquartile range (IQR) 67-80] years; median CHA 2 DS 2 VASc 4 and median HAS-BLED 2. The 4S-AF score would have suggested a rhythm-control strategy in 351 (57.1%) patients while a rate control in 264 (42.9%). The strategy adopted was concordant with the 4S-AF suggestions in 342 (55.6%) cases, and non-concordant in 273 (44.4%). After a median follow-up of 941 days (IQR 365-1282), 113 (18.4%) patients died, 158 (25.7%) had an event of the composite endpoint. On adjusted Cox regression analysis, when 4S-AF score suggested rate control, disagreement with that suggestion was not associated with a worse outcome. When 4S-AF indicated rhythm control, disagreement was associated with a higher risk of all-cause death (HR 7.59; 95% CI 1.65-35.01), and of the composite outcome (HR 2.69; 95% CI 1.19-6.06). The 4S-AF scheme is a useful tool to comprehensively evaluate AF patients and aid the decision-making process. Disagreement with the rhythm control suggestion of the 4S-AF scheme was associated with adverse clinical outcomes., (© 2021. Società Italiana di Medicina Interna (SIMI).)

The aim of this study was to investigate the reliability of a novel electrocardiographic (ECG) marker in predicting ventricular arrhythmia (VA) inducibility in individuals with drug-induced Brugada syndrome (BrS) type I pattern. Consecutive patients with drug-induced type I BrS pattern underwent programmed ventricular stimulation (PVS) and, according to their response, were divided into 2 groups. Clinical characteristics and 12-lead ECG intervals before and after ajmaline infusion were compared between the 2 groups. A novel ECG marker named dST-Tiso interval consisting in the interval between the onset of the coved ST-segment elevation and its termination at the isoelectric line was also evaluated. Our cohort included 76 individuals (median age 44 years, 75% male). Twenty-five (32.9%) had VA inducibility requiring defibrillation. As compared with not inducible subjects, those with VA inducibility were more frequently male (92% vs 65%, p = 0.013), had longer PQ interval (basal: 172 vs 152 ms, p = 0.033; after ajmaline: 216 vs 200 ms, p = 0.040), higher J peak (0.6 vs 0.5 mV, p = 0.006) and longer dST-Tiso (360 vs 240 ms, p < 0.001). The dST-Tiso showed a C-statistics of 0.90 (95% confidence interval: 0.82 to 0.99) and an adjusted odds ratio for VA of 1.03 (1.01 to 1.04, p < 0.001). A dST-Tiso interval >300 ms yielded a sensitivity of 92.0%, a specificity of 90.2%, positive and negative predictive values of 82.1% and 95.8%. In conclusion, the dST-Tiso interval is a powerful predictor of VA inducibility in drug-induced BrS type I pattern. External validation is needed, but this marker might be useful in the clinical counseling process of these individuals before invasive PVS., (Copyright © 2021 Elsevier Inc. All rights reserved.)

Background and Purpose: The Advanced Practice Nurse (APN) Council refined the APN peer review to an objective, data-driven process. The purpose of the study was to assess the interrater reliability of APN peer reviews using the APN Rubric based on Hamric, Spross & Hanson's Model of Advanced Practice Nursing., Methods: A quantitative single-site study with a convenience sample of 80 APN Portfolios., Results: Analysis of six core competencies (direct clinical practice, leadership, consultation/collaboration, coaching/guiding, research, and ethical decision-making) within the APN Rubric demonstrated substantial and near perfect agreement levels in the APN peer review process., Conclusions: The application of APN core competencies within the peer review process demonstrated high consistency, thereby increasing the significance and objectivity of peer review outcomes., (© Copyright 2021 Springer Publishing Company, LLC.)

Background: The COVID-19 pandemic has challenged the ability of health care organisations to provide adequate care. We report the experience of a national tertiary electrophysiology centre in the management of patients with cardiac implantable electronic devices (CIEDs) through the use of a fully remote follow-up model., Methods: We daily and prospectively collected remote monitoring (RM) relevant findings and following clinical actions performed from March 10 th to April 3 rd 2020, a period of suspension of routine ambulatory activity due to the national lockdown., Results: During the study period (25 days), we received 2,215 transmissions from 2,955 devices. Among them, 129 patients reported potential clinically actionable RM observations (event rate: 12.0/1000 patient-week). In 77 patients (60%), RM events triggered a clinical action, but only 5 patients needed an urgent in-hospital access (4 urgent procedures and 1 device reprogramming)., Conclusions: In the unprecedented COVID-19 pandemic, RM became an essential tool in healthcare delivery for CIED patients. We observed that RM was effective in "keep people safe" and "focus only on individuals with health care needs".