Leveraging the holistic benefits of biosimilars in Europe - part 2: how payers can safeguard the future of a healthy biosimilar market environment.

Introduction: Biosimilars have improved access to biologic medicines; however, historical thinking may jeopardize the viability of future markets.

Areas Covered: An expert panel of eight diverse European stakeholders provided insights about rethinking biosimilars and cost-savings, reducing patient access inequalities, increasing inter-market equity, and improving education. The insights reported here (Part 2) follow a study that provides perspectives on leveraging the holistic benefits of biosimilars for market sustainability based on independent survey results and telephone interviews of stakeholders from diverse biosimilar markets (Part 1).

Capturing the holistic value of biosimilars in Europe - part 1: a historical perspective.

Introduction: Approved biosimilars exhibit comparable efficacy, safety, and immunogenicity to reference products. This report provides perspectives on the societal value of biosimilars within Europe and potential factors that have influenced market dynamics.

Methods: An independent, self-administered survey or one-on-one in-depth interview was used to collect viewpoints about the impact of biosimilar medicines within European markets.

Pain during cardiac implantable electronic device implantation.

In order to evaluate the extent and causes of pain during cardiac implantable electronic device (CIED) implantation in our hospital, a prospective audit over a 23-month period using a patient selfreporting questionnaire was undertaken. In total, 599 procedures were reported, 52.9% for pacemaker implantation and 23.

Initial experience of temperature-controlled irrigated radiofrequency ablation for ischaemic cardiomyopathy ventricular tachycardia ablation.

Background: The DiamondTemp ablation (DTA) catheter system delivers high power, open-irrigated, temperature-controlled radiofrequency (RF) ablation. This novel ablation system has not been previously used for ventricular tachycardia (VT) ablation.

Objective: Feasibility of using the DTA catheter system for VT ablation in ischaemic cardiomyopathy (ICM) patients.

Patient Pathways in Cardiology: Should Pharmaceutical and Medical Device Companies Care?

A shared goal of patients, providers, and the companies that produce new therapies is to have these therapies used according to guidelines. Health services specialize in patient care and may lack the capabilities to take a product from conception through to everyday use. This results in a mutually beneficial relationship between health services and industry.

Safety and feasibility of trans-venous cardiac device extraction using conscious sedation alone-Implications for the post-COVID-19 era.

Background: Transvenous lead extraction (TLE) for implantable cardiac-devices is traditionally performed under general anesthesia (GA). This can lead to greater risk of exposure to COVID-19, longer recovery-times and increased procedural-costs. We report the feasibility/safety of TLE using conscious-sedation alone with immediate GA/cardiac-surgery back-up if needed.

Impact of a high-density grid catheter on long-term outcomes for structural heart disease ventricular tachycardia ablation.

Background: Substrate mapping has highlighted the importance of targeting diastolic conduction channels and late potentials during ventricular tachycardia (VT) ablation. State-of-the-art multipolar mapping catheters have enhanced mapping capabilities. The purpose of this study was to investigate whether long-term outcomes were improved with the use of a HD Grid mapping catheter combining complementary mapping strategies in patients with structural heart disease VT.

Long-term follow-up of normal and structural heart ventricular tachycardia catheter ablation: real-world experience from a UK tertiary centre.

Background: Ventricular tachycardia (VT) is associated with increased morbidity and mortality. There is growing evidence for the effectiveness of catheter ablation in improving outcomes in patients with recurrent VT. Consequently the threshold for referral for VT ablation has fallen over recent years, resulting in increased number of procedures.

Enhanced ventricular tachycardia substrate resolution with a novel omnipolar high-density mapping catheter: the omnimapping study.

Background: Defining diastolic slow-conduction channels within the borderzone (BZ) of scar-dependent re-entrant ventricular tachycardia (VT) is key for effective mapping and ablation strategies. Understanding wavefront propagation is driving advances in high-density (HD) mapping. The newly developed Advisor™ HD Grid Mapping Catheter (HD GRID) has equidistant spacing of 16, 1 mm electrodes in a 4 × 4 3 mm interspaced arrangement allowing bipolar recordings along and uniquely across the splines (orthogonal vector) to facilitate substrate mapping in a WAVE configuration (WAVE).

An observational study of endothelial function in early arthritis.

Background: Endothelial dysfunction is present in established rheumatoid arthritis, but it is not clear at what stage of the disease this abnormality develops. We set out to determine whether endothelial damage/dysfunction is present in a group of patients with early arthritis (EA) (new onset inflammatory arthritis, EA).

Materials And Methods: Eighteen patients with EA, 48 healthy controls and 25 disease controls were recruited.

Inflammation and microvascular and macrovascular endothelial dysfunction in rheumatoid arthritis: effect of treatment.

Objective: To determine whether abnormalities in microvascular and macrovascular function in rheumatoid arthritis (RA) are associated with plasma markers [von Willebrand factor (VWF)] of endothelial dysfunction and inflammation [C-reactive protein (CRP)] and whether the abnormalities would be altered by treatment. Endothelial dysfunction and inflammation in RA may contribute to adverse cardiovascular events. Although endothelial dysfunction in RA has been demonstrated by altered plasma markers, the relationships with macrovascular and microvascular function are relatively unexplored.

Inflammatory cytokines, endothelial markers and adhesion molecules in rheumatoid arthritis: effect of intensive anti-inflammatory treatment.

Tumour necrosis factor alpha (TNF-alpha) and interlekin-6 (IL-6) are key inflammatory cytokines in the pathogenesis of rheumatoid arthritis (RA), a disease also associated with endothelial perturbation and increased serum levels of adhesion molecules. As relationships between these processes and molecules are unclear, we tested the hypotheses (a) that TNF-alpha and IL-6 are linked to endothelial activation/damage and levels of soluble adhesion molecules, and (b) that intensive anti-inflammatory treatment improves levels of these indices. We recruited 66 patients with RA, 48 community controls (CC), and 25 disease controls (DC).

Circulating endothelial cells and rheumatoid arthritis: relationship with plasma markers of endothelial damage/dysfunction.

Objectives: RA is associated with endothelial cell dysfunction (ECD) and increased cardiovascular mortality and morbidity. Circulating endothelial cells (CECs) are a novel marker of severe endothelial damage. We hypothesized altered CECs in patients with RA compared with community controls (CCs) and hospital controls (HCs, with diabetes and hypertension) correlate with established plasma markers of inflammation and of ECD.