Investigation of the safety and feasibility of AAV1/SERCA2a gene transfer in patients with chronic heart failure supported with a left ventricular assist device - the SERCA-LVAD TRIAL.

The SERCA-LVAD trial was a phase 2a trial assessing the safety and feasibility of delivering an adeno-associated vector 1 carrying the cardiac isoform of the sarcoplasmic reticulum calcium ATPase (AAV1/SERCA2a) to adult chronic heart failure patients implanted with a left ventricular assist device. The SERCA-LVAD trial was one of a program of AAV1/SERCA2a cardiac gene therapy trials including CUPID1, CUPID 2 and AGENT trials. Enroled subjects were randomised to receive a single intracoronary infusion of 1 × 10 DNase-resistant AAV1/SERCA2a particles or a placebo solution in a double-blinded design, stratified by presence of neutralising antibodies to AAV.

A Portable Chemiluminescence Assay of Alkaline Phosphatase Activity To Monitor Pasteurization of Milk Products.

A chemiluminescence assay using a handheld luminometer to measure the activity of alkaline phosphatase was developed that can detect 0.002% or more of unpasteurized milk in various milk products. Evaluation of the assay followed an National Conference on Interstate Milk Shipments (NCIMS)-approved protocol in which aliquots of pasteurized milk products were spiked with raw milk at various levels.

Prioritising transplantation for adult congenital heart disease, UK national data.

Objective: There are no multi-centre data on the outcomes of transplant for adult congenital heart disease (ACHD) outside of North America. The literature has identified a number of concerns for this population such as increased wait-list and early post-operative mortality. We investigated outcomes in a national cohort to see if these problems are replicated outside of America.

Heart or heart-lung transplantation for patients with congenital heart disease in England.

Background: Increased longevity in patients with congenital heart disease (CHD) is associated with late complications, mainly heart failure, which may not be amenable to redo surgery and become refractory to medical therapy and so, trigger referral for transplantation. We assessed the current role and future prospects of heart and heart-lung transplantation for patients with CHD in England.

Methods: We performed a retrospective analysis of hospital episodes for England for 1997-2015, identifying patients with a CHD code (ICD-10 'Q2xx.

Durable left ventricular assist device support as a bridge to heart transplant candidacy†.

Objectives: Left ventricular assist devices are funded in the UK exclusively as a bridge to transplant (BTT). However, patients who potentially could receive a transplant may develop reversible contraindications to transplant. Bridge to candidacy (BTC) has sometimes been controversial, given the uncertain clinical efficacy of BTC and the risk that reimbursement could be denied.

Patient survival and therapeutic outcome in the UK bridge to transplant left ventricular assist device population.

Objective: To study the survival and patient outcome in a population of UK patients supported by an implantable left ventricular assist device (LVAD) as a bridge to heart transplantation.

Methods: Data on all adult patients (n=342) who received a HeartMate II or HVAD as a first long-term LVAD between January 2007 and 31 December 2013 were extracted from the UK Ventricular Assist Device (VAD) Database in November 2015. Outcomes analysed include survival on a LVAD, time to urgent listing, heart transplantation and complications including those needing a pump exchange.

'Your DNA, Your Say': global survey gathering attitudes toward genomics: design, delivery and methods.

Our international study, 'Your DNA, Your Say', uses film and an online cross-sectional survey to gather public attitudes toward the donation, access and sharing of DNA information. We describe the methodological approach used to create an engaging and bespoke survey, suitable for translation into many different languages. We address some of the particular challenges in designing a survey on the subject of genomics.

ISHLT Primary Graft Dysfunction Incidence, Risk Factors, and Outcome: A UK National Study.

Background: Heart transplantation (HTx) remains the most effective long-term treatment for advanced heart failure. Primary graft dysfunction (PGD) continues to be a potentially life-threatening early complication. In 2014, a consensus statement released by International Society for Heart and Lung Transplantation (ISHLT) established diagnostic criteria for PGD.

Right atrial and ventricular echocardiographic strain analysis predicts requirement for right ventricular support after left ventricular assist device implantation.

Aims: The need for right ventricular assist device (RVAD) support after left ventricular assist device (LVAD) therapy is associated with increased morbidity and mortality. We used 2D echocardiographic strain analysis to assess right atrial (RA) and right ventricular (RV) mechanics and predict the need for RV mechanical support after LVAD implantation.

Methods And Results: Seventy advanced chronic heart failure (ACHF) patients [59 male, age 47 ± 12 years, 79% dilated cardiomyopathy, left ventricular ejection fraction 23 ± 10%] received continuous-flow LVAD as a bridge to transplantation over an 18 month period.

Cardiac transplantation in a 20-year-old woman with scleroderma.

Purpose: To describe cardiac transplantation in a young woman with juvenile onset diffuse scleroderma and cardiac involvement.

Methods: Case report.

Results: A young White girl developed anti-topoisomerase-1 positive diffuse scleroderma aged 14 years with myositis.

The interval between brainstem death and cardiac assessment influences the retrieval of hearts for transplantation.

Objectives: The optimum time after brainstem death (BSD) at which to assess the function of donor hearts is unknown. We hypothesized that a longer interval may be associated with a higher transplantation rate due to improved function.

Methods: Data were obtained from the UK Transplant Registry for the period between April 2010 and March 2015.

The global forum on bioethics in research meeting, "ethics of research in pregnancy": emerging consensus themes and outputs.

Research during pregnancy is affected by multiple ethical challenges which have not received sufficient international attention and consideration from the bioethics, clinical, and policymaking communities working together. Unresolved ethical questions about research in pregnancy have significant detrimental impacts on maternal and newborn health, in part because they inhibit an evidence base being developed on the efficacy and safety of medicines and health interventions for pregnant women. These problems are compounded in low- and middle-income country (LMIC) settings due to variability in regulatory provisions, the burden of maternal morbidity and mortality, and many social and cultural conventions that impact on pregnant women's ability to participate in research.

Acute fulminant necrotizing eosinophilic myocarditis: early diagnosis and treatment.

Necrotizing eosinophilic myocarditis is a rare but potentially fatal condition that requires prompt recognition and treatment. We describe a case of a young athlete presenting with chest pain and breathlessness, with evidence of rapidly deteriorating cardiac function. The condition was successfully treated with corticosteroids, with no evidence of residual myocardial damage.

Algorithms to guide ambulance clinicians in the management of emergencies in patients with implanted rotary left ventricular assist devices.

Advances in left ventricular assist device (LVAD) therapy have resulted in increasing numbers of adult LVAD recipients in the community. However, device failure, stroke, bleeding, LVAD thrombosis and systemic infection can be life-threatening emergencies. Currently, four LVAD systems are implanted in six UK transplant centres, each of which provides device-specific information to local emergency services.

Quality of life of advanced chronic heart failure: medical care, mechanical circulatory support and transplantation.

Objectives: Advanced chronic heart failure (ACHF) is progressive with poor prognosis and quality of life (QoL). Heart transplantation (HTx) is an effective treatment for ACHF, but is limited by scarcity of donor hearts. Left ventricular assist device (LVAD) support is a useful bridging therapy, and short- and medium-term outcomes have improved.

Investigation of the Characteristics of HeartWare HVAD and Thoratec HeartMate II Under Steady and Pulsatile Flow Conditions.

The aim of this study was to elucidate the dynamic characteristics of the Thoratec HeartMate II (HMII) and the HeartWare HVAD (HVAD) left ventricular assist devices (LVADs) under clinically representative in vitro operating conditions. The performance of the two LVADs were compared in a normothermic, human blood-filled mock circulation model under conditions of steady (nonpulsatile) flow and under simulated physiologic conditions. These experiments were repeated using 5% dextrose in order to determine its suitability as a blood analog.

Preoperative predictors and outcomes of right ventricular assist device implantation after continuous-flow left ventricular assist device implantation.

Objective: The outcomes of ventricular assist device therapy remain limited by right ventricular failure. We sought to define the predictors and evaluate the outcomes of right ventricular failure requiring right ventricular assist device support after long-term continuous-flow left ventricular assist device implantation.

Methods: Records of all continuous-flow left ventricular assist device recipients for the last 10 years were analyzed, including patients on preoperative intra-aortic balloon pump, extracorporeal membrane oxygenation, and short-term ventricular assist device support.

Does postoperative blood pressure influence development of aortic regurgitation following continuous-flow left ventricular assist device implantation?†.

Objectives: The true impact of postoperative blood pressure (BP) control on development of aortic regurgitation (AR) following continuous-flow left ventricular assist device (CF-LVAD) implantation remains uncertain. This study examines the influence of BP in patients with de novo AR following CF-LVAD implantation.

Methods: All patients with no or View Article and Find Full Text PDF

Usefulness of Rabbit Anti-thymocyte Globulin in Patients With Giant Cell Myocarditis.

Giant cell myocarditis (GCM) is an aggressive inflammatory myocardial disease. Immunosuppression is an effective treatment for some cases. However, the duration of action of agents such as muromonab CD3 is short and others such as the calcineurin inhibitors may lead to renal failure.