The Use of App-based Follow-up of Cardiac Implantable Electronic Devices

There has been a steady rise in the number of patients treated with cardiac implantable electrical devices. Remote monitoring and remote follow-up have proven superior to conventional care in the follow-up of these patients and represent the new standard of care. With the widespread availability of smartphones and with more people using them for health queries, app-based remote care offers a promising new digital health solution promoting the shift of follow-up to exception-based assessments. It focuses on patients’ enablement and has shown promising results, but also highlights the need to increase the system’s automaticity to achieve acceptable follow-up adherence rates. MyCareLink Heart is a fully automated app-based system that represents the next generation of app-based monitoring and is currently being evaluated in an international study with promising initial results

Incidence of premature battery depletion in subcutaneous cardioverter-defibrillator patients: insights from a multicenter registry.

BACKGROUND The subcutaneous ICD established its role in the prevention of sudden cardiac death in recent years. The occurrence of premature battery depletion in a large subset of potentially affected devices has been a cause of concern. The incidence of premature battery depletion has not been studied systematically beyond manufacturer-reported data. METHODS Retrospective data and the most recent follow-up data on S-ICD devices from fourteen centers in Europe, the US, and Canada was studied. The incidence of generator removal or failure was reported to investigate the incidence of premature S-ICD battery depletion, defined as battery failure within 60 months or less. RESULTS Data from 1054 devices was analyzed. Premature battery depletion occurred in 3.5% of potentially affected devices over an observation period of 49 months. CONCLUSIONS The incidence of premature battery depletion of S-ICD potentially affected by a battery advisory was around 3.5% after 4 years in this study. Premature depletion occurred exclusively in devices under advisory. This is in line with the most recently published reports from the manufacturer. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT04767516

Burnout among surgeons before and during the SARS-CoV-2 pandemic: an international survey

Background: SARS-CoV-2 pandemic has had many significant impacts within the surgical realm, and surgeons have been obligated to reconsider almost every aspect of daily clinical practice. Methods: This is a cross-sectional study reported in compliance with the CHERRIES guidelines and conducted through an online platform from June 14th to July 15th, 2020. The primary outcome was the burden of burnout during the pandemic indicated by the validated Shirom-Melamed Burnout Measure. Results: Nine hundred fifty-four surgeons completed the survey. The median length of practice was 10 years; 78.2% included were male with a median age of 37 years old, 39.5% were consultants, 68.9% were general surgeons, and 55.7% were affiliated with an academic institution. Overall, there was a significant increase in the mean burnout score during the pandemic; longer years of practice and older age were significantly associated with less burnout. There were significant reductions in the median number of outpatient visits, operated cases, on-call hours, emergency visits, and research work, so, 48.2% of respondents felt that the training resources were insufficient. The majority (81.3%) of respondents reported that their hospitals were included in the management of COVID-19, 66.5% felt their roles had been minimized; 41% were asked to assist in non-surgical medical practices, and 37.6% of respondents were included in COVID-19 management. Conclusions: There was a significant burnout among trainees. Almost all aspects of clinical and research activities were affected with a significant reduction in the volume of research, outpatient clinic visits, surgical procedures, on-call hours, and emergency cases hindering the training. Trial registration: The study was registered on clicaltrials.gov "NCT04433286" on 16/06/2020

Subcutaneous implantable cardiac defibrillator - A personalised approach

Sudden cardiac death (SCD) remains one of the leading causes of death in the modern world with most of these deaths being attributed to ventricular arrhythmias. Implantable cardiac defibrillators (ICDs) are well established treatment and are recommended by the international guidelines for prevention of sudden cardiac death triggered by ventricular arrhythmias in high-risk populations. But they are not risk-free, and traditional transvenous ICDs are associated with long-term complications with potentially fatal consequences. The subcutaneous ICD (S-ICD) was designed utilising a totally extra-thoracic approach avoiding the complications which have been associated with transvenous ICDs (TV-ICD). The results of clinical trials demonstrated the efficacy of the S-ICD systems in recognising and treating ventricular arrythmias with fewer lead-related complications when compared to the TV-ICDs. However, the downside of the S-ICDs is that unlike TV-ICDs, they are unable to provide bradycardia pacing or Anti-tachycardia pacing (ATP) therapy to terminate ventricular arrythmias painlessly without the need to deliver a shock. Also, they exhibit a relatively higher rate of inappropriate shocks when compared with TV-ICDs. Most of these shocks can be attributed to Twave oversensing (TWO), an inherent risk to the sensing mechanism of the S-ICD. Not all patients are eligible for S-ICDs and mandatory screening of all potential candidates following device manufacturer guidelines helps identify eligible patients based on their underlying ECG morphology. Variable rates of screening success and S-ICD eligibility are reported in the literature. In this thesis I will start by reporting a retrospective analysis of S-ICD eligibility using current recommended screening practices at a tertiary centre for cardiac devices (University Hospital of Southampton). I will then proceed to suggest adopting a different approach towards screening of S-ICD candidates which considers the dynamicity of the ECG signal. I will explore the role of applying prolonged screening using Holter monitors in a wide range of patients’ cohorts and prove there is variation in the S-ICD eligibility overtime which can explain oversensing and inappropriate shocks in S-ICDs despite current screening practices. I will also introduce and explain a novel technique utilising artificial intelligence and deep learning methods which has the potential to be applied to clinical practice to help identify S-ICD eligible patients as well as guide vector selection in S-ICD recipients. I will justify choosing R:T ratio as the main determinant of S-ICD eligibility and validate the novel deep learning methodology used in my studies by comparing the outcomes to those produced by the “gold standard” S-ICD simulator. I will then proceed to propose targeting less strict R:T ratios in S-ICD screening in vectors that prove to be stable with prolonged screening. I will then compare the eligibility rates for S-ICD using different R:T ratios, proposing that it is reasonable to revisit the S-ICD Screening thresholds if we adopt prolonged screening approaches. Afterwards, I will address the inability of S-ICDs to provide pacing therapy and the need to coimplant pacemaker devices to cover pacing therapy when clinically indicated. I will highlight that the effect of pacing on the S-ICD sensing has not been well studied before. I will proceed by first introducing a simple radiological method to define the LP position, then demonstrate that there is no effect of LP position on short- and long-term LPs performances. Afterwards I will show that pacing regardless of the pacing site has a significant effect on the R:T ratio, one of the main determinants of S-ICD eligibility and increases the risk of S-ICD oversensing. However, I will conclude that with adoption of personalised approach towards device therapy, it is theoretically feasible to utilise concomitant device therapies in most patients, without increasing the risk of adverse clinical events. In summary, I believe that extravascular cardiac devices are soon to establish themselves as the new standard of care to provide defibrillation protection and pacing therapy. Current issues with S-ICDs can be overcome by incorporating efficient artificial intelligence methods to help with more accurate and yet efficient screening for better patient selection. Together with adopting a personalised approach, higher S-ICD eligibility can be achieved, and the risk of inappropriate shocks can be mitigated

Evaluation of a quality improvement intervention to reduce anastomotic leak following right colectomy (EAGLE): pragmatic, batched stepped-wedge, cluster-randomized trial in 64 countries

Background Anastomotic leak affects 8 per cent of patients after right colectomy with a 10-fold increased risk of postoperative death. The EAGLE study aimed to develop and test whether an international, standardized quality improvement intervention could reduce anastomotic leaks. Methods The internationally intended protocol, iteratively co-developed by a multistage Delphi process, comprised an online educational module introducing risk stratification, an intraoperative checklist, and harmonized surgical techniques. Clusters (hospital teams) were randomized to one of three arms with varied sequences of intervention/data collection by a derived stepped-wedge batch design (at least 18 hospital teams per batch). Patients were blinded to the study allocation. Low- and middle-income country enrolment was encouraged. The primary outcome (assessed by intention to treat) was anastomotic leak rate, and subgroup analyses by module completion (at least 80 per cent of surgeons, high engagement; less than 50 per cent, low engagement) were preplanned. Results A total 355 hospital teams registered, with 332 from 64 countries (39.2 per cent low and middle income) included in the final analysis. The online modules were completed by half of the surgeons (2143 of 4411). The primary analysis included 3039 of the 3268 patients recruited (206 patients had no anastomosis and 23 were lost to follow-up), with anastomotic leaks arising before and after the intervention in 10.1 and 9.6 per cent respectively (adjusted OR 0.87, 95 per cent c.i. 0.59 to 1.30; P = 0.498). The proportion of surgeons completing the educational modules was an influence: the leak rate decreased from 12.2 per cent (61 of 500) before intervention to 5.1 per cent (24 of 473) after intervention in high-engagement centres (adjusted OR 0.36, 0.20 to 0.64; P < 0.001), but this was not observed in low-engagement hospitals (8.3 per cent (59 of 714) and 13.8 per cent (61 of 443) respectively; adjusted OR 2.09, 1.31 to 3.31). Conclusion Completion of globally available digital training by engaged teams can alter anastomotic leak rates. Registration number: NCT04270721 (http://www.clinicaltrials.gov)