AlcoChange: A digital therapeutic for patients with alcohol-related liver disease.

Background & Aims: Maintenance of abstinence in alcohol-related liver disease (ARLD) is a major unmet therapeutic need. Digital therapeutics can deliver ongoing behavioural therapy, in real-time, for chronic conditions. The aim of this project was to develop and clinically test AlcoChange, a novel digital therapeutic for ARLD. Methods: AlcoChange was developed using validated behaviour change techniques and a digital alcohol breathalyser. This was an open-label, single-centre study. Patients with ARLD, ongoing alcohol use (within 1 month) and possession of a suitable smartphone were eligible. Patients were recruited from inpatient and outpatient settings, and received AlcoChange therapy for 3 months. The primary outcome was reduction in alcohol use from baseline to 3 months, measured by timeline follow-back. Secondary outcomes included: (i) compliance with the AlcoChange app, (ii) alcohol-related and all-cause hospital re-admissions up to 1 year, (iii) qualitative analysis to determine factors associated with compliance. Results: Sixty-five patients were recruited, of whom 41 completed the study per protocol. Patients compliant with the intervention (>60 logins over 3 months) had a significant reduction in alcohol use from baseline compared to non-compliant patients (median [IQR]: -100% [100% to -55.1%] vs. -57.1% [-95.3% to +32.13%], p = 0.029). The proportion attaining abstinence at 3 months was higher in the compliant group (57.1% vs. 22.2%, p = 0.025). The compliant group had a significantly decreased risk of subsequent alcohol-related re-admission up to 12 months (p = 0.008). Qualitative analysis demonstrated that receiving in-app feedback and the presence of a health-related 'sentinel event' were predictors of compliance with the intervention. Conclusions: Use of the novel digital therapeutic, AlcoChange, was associated with a significant reduction in alcohol use and an increase in the proportion of patients with ARLD attaining abstinence. Definitive randomised trials are warranted for this intervention. Impact and implications: Alcohol-related liver disease (ARLD) is an increasing health problem worldwide. The main cause of death and disability in ARLD is ongoing alcohol consumption, but few patients receive medications or talking therapy to maintain abstinence. This study demonstrated that a digital therapeutic, linked to a smartphone, may help reduce alcohol consumption and alcohol-related hospital admissions in these patients. If validated in larger, randomised, trials, digital therapeutics may have a role in the primary and secondary prevention of complicatons from ARLD.

Outcomes of transcatheter pulmonary SAPIEN 3 valve implantation: an international registry.

BACKGROUND AND AIMS: Transcatheter pulmonary valve implantation (TPVI) is indicated to treat right-ventricular outflow tract (RVOT) dysfunction related to congenital heart disease (CHD). Outcomes of TPVI with the SAPIEN 3 valve that are insufficiently documented were investigated in the EUROPULMS3 registry of SAPIEN 3-TPVI. METHODS: Patient-related, procedural, and follow-up outcome data were retrospectively assessed in this observational cohort from 35 centres in 15 countries. RESULTS: Data for 840 consecutive patients treated in 2014-2021 at a median age of 29.2 (19.0-41.6) years were obtained. The most common diagnosis was conotruncal defect (70.5%), with a native or patched RVOT in 50.7% of all patients. Valve sizes were 20, 23, 26, and 29 mm in 0.4%, 25.5%, 32.1%, and 42.0% of patients, respectively. Valve implantation was successful in 98.5% [95% confidence interval (CI), 97.4%-99.2%] of patients. Median follow-up was 20.3 (7.1-38.4) months. Eight patients experienced infective endocarditis; 11 required pulmonary valve replacement, with a lower incidence for larger valves (P = .009), and four experienced pulmonary valve thrombosis, including one who died and three who recovered with anticoagulation. Cumulative incidences (95%CI) 1, 3, and 6 years after TPVI were as follows: infective endocarditis, 0.5% (0.0%-1.0%), 0.9% (0.2%-1.6%), and 3.8% (0.0%-8.4%); pulmonary valve replacement, 0.4% (0.0%-0.8%), 1.3% (0.2%-2.4%), and 8.0% (1.2%-14.8%); and pulmonary valve thrombosis, 0.4% (0.0%-0.9%), 0.7% (0.0%-1.3%), and 0.7% (0.0%-1.3%), respectively. CONCLUSIONS: Outcomes of SAPIEN 3 TPVI were favourable in patients with CHD, half of whom had native or patched RVOTs.

Infective endocarditis after transcatheter pulmonary valve implantation in patients with congenital heart disease: Distinctive features.

The introduction of transcatheter pulmonary valve implantation (TPVI) has greatly benefited the management of right ventricular outflow tract dysfunction. Infective endocarditis (IE) is a feared complication of TPVI that affects valve durability and patient outcomes. Current recommendations provide only limited guidance on the management of IE after TPVI (TPVI-IE). This article, by a group of experts in congenital heart disease in children and adults, interventional cardiology, infectious diseases including IE, and microbiology, provides a comprehensive review of the current evidence on TPVI-IE, including its incidence, risk factors, causative organisms, diagnosis, and treatment. The incidence of TPVI-IE varies from 13-91/1000 person-years for Melody valves to 8-17/1000 person-years for SAPIEN valves. Risk factors include history of IE, DiGeorge syndrome, immunosuppression, male sex, high residual transpulmonary gradient and portal of bacteria entry. Staphylococci and streptococci are the most common culprits, whereas Staphylococcus aureus is associated with the most severe disease. In addition to the modified Duke criteria, a high residual gradient warrants a strong suspicion. Imaging studies are helpful for the diagnosis. Intravenous antibiotics guided by blood culture results are the mainstay of treatment. Invasive re-intervention may be required. TPVI-IE in patients with congenital heart disease exhibits several distinctive features. Whether specific valve types are associated with a higher risk of TPVI-IE requires further investigation. Patient and parent education regarding IE prevention may have a role to play and should be offered to all patients.

Transcatheter closure with a "single lobe" Amplatzer Vascular Plug of a tubular patent ductus arteriosus in a neonate with transposition of the great arteries and heart failure.

A patent ductus arteriosus in patients with transposition of the great arteries is usually beneficial to allow shunting between pulmonary and systemic circulations. However, if the duct is too large, it can cause haemodynamic instability, pulmonary oedema and compromised organ perfusion. We present a neonate in whom a 5 mm short and tubular ductus arteriosus was causing significant cardiac failure with necrotising enterocolitis and liver impairment, leaving him too unstable for the arterial switch operation. At day 14 of life (3.1 kg), the baby underwent successful transcatheter closure using an Amplatzer vascular plug (Abbott, Chicago, Il, USA) delivered through a 5Fr catheter from the aortic side. The procedure was uncomplicated and successful as the neonate was extubated 2 days later. He subsequently underwent successful arterial switch surgery.

Clinico-radiological Presentation of COVID-19 Patients at a Tertiary Care Center at Bhilwara Rajasthan, India.

BACKGROUND: COVID-19 has now become a pandemic. From Wuhan, China, in December 2019 to European countries, USA and now it seems to gain a strong foothold in India. The objective of this work is to report the initial experience with demographic and clinical features, and management of COVID-19 patients admitted in medical college Bhilwara, India. METHODS: This is a descriptive case series of first 26 COVID-19 patients. Demographical, clinical, laboratory, and radiological characteristics and treatment and outcomes data were obtained with data collection forms and history given by 26 COVID-19 patients. RESULTS AND DISCUSSION: During this study 26 COVID-19 positive patients were admitted in MG Hospital, Bhilwara. Male patients were 61.54% and majority (88.46%) were below 60 years of age. Approximately 30.76 % patients were asymptomatic. Fever was the most common symptom (61.54%) followed by sore throat (53.84 %), cough (42.30%) myalgia (38.46%)and dyspnea(23.07%). Six patients (23.07%) of total 26 had comorbidities. Leucopenia was seen in in 9 (34.61%) and leukocytosis was seen in 2 patient. Ten patient (38.46%) out of 26 shown increased lymphocyte/neutrophil ratio. Chest X- ray was normal in 20 patients (76.92%). Abnormalities in chest CT were detected among 10 (38.46%) patients. Typical findings were bilateral multifocal patchy peripheral subsegmental areas of consolidation more towards middle and lower zones and bilateral ground glass opacities involving multiple segments. Oseltamivir and chloroquine were given to all 26 patients. Azithromycin was given in 24 patients. Mean duration of conversion of COVID-19 patients was 6.83 days. All discharged patients advised home quarantine for 14 days as per guidelines. CONCLUSION: Patients often present without fever, and many may not have abnormal radiologic findings. Patients with older age and associated comorbid conditions (COPD and diabetes) seem to have greater risk for lung injury.

Improved ventilation in premature babies after transcatheter versus surgical closure of patent ductus arteriosus.

AIMS: Patent ductus arteriosus (PDA) is common in preterm infants and can contribute to morbidity and mortality. We aimed to compare results and outcome of transcatheter closure using the Amplatzer Piccolo Occluder versus surgical closure in 2 matched groups of preterm infants weighing <3000 g. METHODS AND RESULTS: A total of 147 babies from three tertiary centres were retrospectively analysed. Sixty-four babies undergoing catheter closure were compared with 83 matched surgical cases. Patent ductus arteriosus closure was successful in all cases. During neonatal unit course, mortality was 6.3% (n = 4) after catheterization and 12% (n = 10) after surgery (p = 0.24). Median duration of mechanical ventilation was shorter after catheterisation than after surgery (3 vs 5 days, p = 0.035). Before 4 weeks of age the difference between transcatheter and surgical closure for mechanical ventilation was even more pronounced (3 vs 9 days, p = 0.022). Additionally, when catheterisation was performed before 4 weeks, babies were discharged home earlier as compared to those who underwent closure later in life (39+1 vs. 42+1 weeks, p = 0.021). Such difference was not found in the surgical group. CONCLUSIONS: Transcatheter closure of patent ductus arteriosus is safe, effective and is associated with shorter mechanical ventilation than after surgery. Hospital stay might be shorter when performed earlier in life.

Severe Migraine Associated With Nickel Allergy Requiring Surgical Removal of Atrial Septal Device.

Few patients experience migraines after transcatheter closure of secundum atrial septal defects with nitinol devices. These migraines are usually treated with analgesics and resolve after a few months as the device endothelializes. This report describes the case of a 16-year-old male patient who required surgical explantation of the device 6 years after closure because of debilitating headaches. He had a grade 1 reaction to nickel after skin testing. Intraoperatively, the device had not fully endothelialized. Immediately after removal of the device, his headaches completely resolved. Long-term nickel allergy may cause severe migraine secondary to a lack of endothelialization of a device. Patients with extreme cases may require surgical removal of the device.

Atrial septal defect closure: indications and contra-indications.

Transcatheter closure has become an accepted alternative to surgical repair for ostium secundum atrial septal defects (ASD). However, large ASDs (>38 mm) and defects with deficient rims are usually not offered transcatheter closure but are referred for surgical closure. Transcatheter closure also remains controversial for other complicated ASDs with comorbidities, additional cardiac features and in small children. This article not only provides a comprehensive, up-to-date description of the current indications and contra-indications for ASD device closure, but also further explores the current limits for transcatheter closure in controversial cases. With the devices and technology currently available, several cohort studies have reported successful percutaneous closure in the above-mentioned complex cases. However the feasibility and safety of transcatheter technique needs to be confirmed through larger studies and longer follow-up.