Background: The Subcutaneous ICD (S-ICD) is safe and effective for sudden cardiac death prevention. However, patients in previous S-ICD studies had fewer comorbidities, less left ventricular dysfunction and received more inappropriate shocks (IAS) than in typical transvenous (TV)-ICD trials. The UNTOUCHED trial was designed to evaluate the IAS rate in a more typical, contemporary ICD patient population implanted with the S-ICD using standardized programming and enhanced discrimination algorithms. Methods: Primary prevention patients with left ventricular ejection fraction (LVEF) ≤ 35% and no pacing indications were included. Generation 2 or 3 S-ICD devices were implanted and programmed with rate-based therapy delivery for rates ≥ 250 beats per minute (bpm) and morphology discrimination for rates ≥200 and < 250 bpm. Patients were followed for 18 months. The primary endpoint was the IAS free rate compared to a 91.6% performance goal, derived from the results for the ICD-only patients in the MADIT-RIT study. Kaplan-Meier analyses were performed to evaluate event-free rates for IAS, all cause shock, and complications. Multivariable proportional hazard analysis was performed to determine predictors of endpoints. Results: S-ICD implant was attempted in 1116 patients and 1111 patients were included in post-implant follow-up analysis. The cohort had a mean age of 55.8±12.4 years, 25.6% women, 23.4% black race, 53.5% with ischemic heart disease, 87.7% with symptomatic heart failure and a mean LVEF of 26.4±5.8%. Eighteen-month freedom from IAS was 95.9% (Lower confidence limit LCL 94.8%). Predictors of reduced incidence of IAS were implanting the most recent generation of device, using the three-incision technique, no history of atrial fibrillation, and ischemic etiology. The 18-month all cause shock free rate was 90.6% (LCL 89.0%), meeting the prespecified performance goal of 85.8%. Conversion success rate for appropriate, discrete episodes was 98.4%. Complication free rate at 18 months was 92.7%. Conclusions: This study demonstrates high efficacy and safety with contemporary S-ICD devices and programming despite the relatively high incidence of co-morbidities in comparison to earlier S-ICD trials. The inappropriate shock rate (3.1% at one year) is the lowest reported for the S-ICD and lower than many TV ICD studies using contemporary programming to reduce IAS. Clinical Trial Registration: URL https://clinicaltrials.gov Unique Identifier NCT02433379
The National Health Service (NHS) has rapidly adopted telemedicine solutions as an alternative to face-to-face consultations during the COVID-19 pandemic. The majority of HCPs (Healthcare Professionals) were unfamiliar with Telemedicine prior to the current pandemic. Remote consultation is expected to continue for the foreseeable future, thus we designed this survey. A survey designed to evaluate the use of telephone consultation by HCPs, assessing its implementation, challenges and drawbacks. A web link survey conducted through SurveyMonkey was sent to HCPs across six UK Trusts the period of May 2020. The survey received 114 responses (84%) being doctors. 95% of respondents had not received training prior to engaging in telemedicine consultations. 64% were unaware of the updated General Medical Council guidance concerning remote consultations. The most common barrier in remote consultation was the inability to access patient records raised by 37% of respondents. However, 73% of respondents felt that patients understood their medical condition and the instructions given to them over the phone, and 70% agreed that videoconference consultations would add to patients care. Telemedicine can be used for selected groups of patients in the post COVID-19 era, and the HCPs carrying that should have the sufficient experience and knowledge expected to operate these clinics.
Summary Anaesthetic equipment plays a central role in anaesthetic practice but brings the potential for malfunction or misuse. We aimed to explore the national picture by reviewing patient safety incidents relating to anaesthetic equipment from the National Reporting and Learning System for England and Wales between 2006 and 2008. We searched the database using the system’s own classification and by scrutinising the free text of relevant incidents. There were 1029 relevant incidents. Of these, 410 (39.8%) concerned patient monitoring, most commonly screen failure during anaesthesia, failure of one modality or failure to transfer data automatically from anaesthetic room to operating theatre. Problems relating to ventilators made up 185 (17.9%) of the reports. Sudden failures during anaesthesia accounted for 142 (13.8%) of these, with a further 10 cases (0.9%) where malfunction caused a sustained or increasing positive pressure in the patient’s airway. Leaks made up 99 (9.6%) of incidents and 53 (5.2%) of incidents arose from the use of infusion pumps. Most (89%) of the incidents caused no patient harm; only 30 (2.9%) were judged to have led to moderate or severe harm. Although equipment was often faulty, user error or unfamiliarity also played a part. A large variety of causes led to a relatively small number of clinical scenarios, that anaesthetists should be ready, both individually and organisationally, to manage even when the cause is not apparent. We make recommendations for enhancing patient safety with respect to equipment. You can respond to this article at http://www.anaesthesiacorrespondence.com
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