The totally subcutaneous implantable-defibrillator (S-ICD) is a new alternative to the conventional transvenous ICD system to minimize intravascular lead complications. There are limited data ...describing the long-term performance of the S-ICD. This paper presents the first large international patient population collected as part of the EFFORTLESS S-ICD Registry.
The EFFORTLESS S-ICD Registry is a non-randomized, standard of care, multicentre Registry designed to collect long-term, system-related, clinical, and patient reported outcome data from S-ICD implanted patients since June 2009. Follow-up data are systematically collected over 60-month post-implant including Quality of Life. The study population of 472 patients of which 241 (51%) were enrolled prospectively has a mean follow-up duration of 558 days (range 13-1342 days, median 498 days), 72% male, mean age of 49 ± 18 years (range 9-88 years), 42% mean left ventricular ejection fraction. Complication-free rates were 97 and 94%, at 30 and 360 days, respectively. Three hundred and seventeen spontaneous episodes were recorded in 85 patients during the follow-up period. Of these episodes, 169 (53%) received therapy, 93 being for Ventricular Tachycardia/Fibrillation (VT/VF). One patient died of recurrent VF and severe bradycardia. Regarding discrete VT/VF episodes, first shock conversion efficacy was 88% with 100% overall successful clinical conversion after a maximum of five shocks. The 360-day inappropriate shock rate was 7% with the vast majority occurring for oversensing (62/73 episodes), primarily of cardiac signals (94% of oversensed episodes).
The first large cohort of real-world data from an International patient S-ICD population demonstrates appropriate system performance with clinical event rates and inappropriate shock rates comparable with those reported for conventional ICDs. Clinical trial registration URL: http://www.clinicaltrials.gov. Unique identifier NCT01085435.
Objectives
Paediatric feeding difficulties are common, affecting up to 25% of otherwise healthy children, symptoms include food refusal, gagging, choking, and excessive mealtime duration. These ...symptoms are commonly described in pre‐operative discussions about tonsillectomy. This prospective study explores the impact of tonsillectomy on paediatric feeding difficulties.
Design
This prospective cohort study invited caregivers of children undergoing tonsillectomy to complete a PediEAT questionnaire about their children's feeding behaviours, pre and post‐operatively. The study was completed in two phases with 9 questions administered in phase 1 and three additional questions added for phase 2. A free text comments box was also provided. Responses were graded from 0 to 5, where 0 is ‘never a problem’ and 5 is ‘always a problem’ with eating behaviours.
Setting
The study was conducted at our institution, a tertiary paediatric ENT unit.
Participants
Children aged between 6 months ‐ 7 years undergoing tonsillectomy for any indication were invited to participate.
Main outcome measures
Changes to the Pedi‐EAT scores pre and post operatively were the main outcome measure.
Results
102 participants were recruited between January 2020 and January 2022. The mean age of participants was 4.1 years, 87% had a concurrent adenoidectomy. The mean time to completion of post‐operative questionnaire was 23 weeks after surgery. 9 of the 12 questions showed a statistically significant improvement in post‐operative scores using a paired student t‐test (p < 0.05). The most significant improvements related to ‘gets tired from eating and is not able to finish’ (1.49 pre‐op, 0.91 post op, p < 0.01) and ‘eats food that needs to be chewed’ (1.4 pre‐op, 0.72 post‐op, p < 0.01). 13% of participants only underwent tonsillectomy and this group also showed a statistically significant improvement in fatigue during eating (p < 0.05).
Conclusion
Symptoms of fatigue during eating and avoidance of food requiring mastication are most likely to improve following tonsillectomy in children.
Abstract Over the past two decades the quest for quantitative evaluation of left ventricular function and regional wall motion has escalated, allowing several aspects of myocardial contractile ...patterns to be quantified, both during stress echocardiography and in the assessment of dyssynchrony. Most of the literature to date has used Tissue Doppler Imaging (TDI) techniques to assess essentially long-axis function due to the angle dependency of Doppler based techniques. This brief review introduces the early development, validation and potential clinical applications of a new technique of quantifying two-dimensional (radial and circumferential) strains and strain rates through tracking myocardial “speckles”. In-vivo and in-vitro validation of this 2D-strain imaging technique has been undertaken and reached a point where it is considered ready for more widespread investigations into clinical utility. One important advantage over TDI techniques is that it is not limited by dependency on the angle of insonation. Several recent studies looking at ventricular function in specific groups of patients have reported practical ability to distinguish the abnormally from the normally contracting regions of ventricular walls. It provides new and complementary quantitative information about ventricular dyssynchrony and regional wall motion abnormalities. More research studies are needed to determine the sensitivity and specificity of the measurements obtained using this technique and define its strengths and limitations. In particular, whether the measured values correlate well with clinical outcomes will need to be established in longitudinal interventional studies. The clinical utilities of this technique over the coming years are likely to expand rapidly.
The ecto-enzyme CD38 is gaining momentum as a novel therapeutic target for patients with hematological malignancies, with several anti-CD38 monoclonal antibodies in clinical trials with promising ...results. In chronic lymphocytic leukemia (CLL) CD38 is a marker of unfavorable prognosis and a central factor in the pathogenetic network underlying the disease: activation of CD38 regulates genetic pathways involved in proliferation and movement. Here we show that CD38 is enzymatically active in primary CLL cells and that its forced expression increases disease aggressiveness in a xenograft model. The effect is completely lost when using an enzyme-deficient version of CD38 with a single amino-acid mutation. Through the enzymatic conversion of NAD into ADPR (ADP-ribose) and cADPR (cyclic ADP-ribose), CD38 increases cytoplasmic Ca(2+) concentrations, positively influencing proliferation and signaling mediated via chemokine receptors or integrins. Consistently, inhibition of the enzymatic activities of CD38 using the flavonoid kuromanin blocks CLL chemotaxis, adhesion and in vivo homing. In a short-term xenograft model using primary cells, kuromanin treatment traps CLL cells in the blood, thereby increasing responses to chemotherapy. These results suggest that monoclonal antibodies that block the enzymatic activities of CD38 or enzyme inhibitors may prove therapeutically useful.
To assess the cost-effectiveness of radiofrequency catheter ablation (RFCA) compared with anti-arrhythmic drug (AAD) therapy for the treatment of atrial fibrillation (AF) from the perspective of the ...UK NHS.
Bayesian evidence synthesis and decision analytical model.
A systematic review and meta-analysis was conducted and Bayesian statistical methods used to synthesise the effectiveness evidence from randomised control trials. A decision analytical model was developed to assess the costs and consequences associated with the primary outcome of the trials over a lifetime time horizon.
Costs from a health service perspective and outcomes measured as quality-adjusted life years (QALYs).
The incremental cost-effectiveness ratio of RFCA varied between pound7763 and pound7910 for each additional QALY according to baseline risk of stroke, with a probability of being cost-effective from 0.98 to 0.99 for a cost-effectiveness threshold of pound20 000. Results were sensitive to the duration of quality of life benefits from treatment.
RFCA is potentially cost-effective for the treatment of paroxysmal AF in patients' predominantly refractory to AAD therapy provided the quality-of-life benefits from treatment are maintained for more than 5 years. These findings remain subject to limitations in the existing evidence regarding the nature of life benefits and the prognostic importance of restoring normal sinus rhythm conferred using RFCA.