Boston Scientific (Barbados)

Objectives: BT is a one-time treatment recommended as a GINA Step 5 add-on treatment for severe uncontrolled asthma as an alternative to monthly injected biologic OM. No clinical trials have directly compared BT and OM. An indirect treatment comparison (ITC) is presented using optimized asthma therapy (OAT) as a common control. ITCs are often utilised in health technology assessment to establish comparative effectiveness in the absence of direct trial evidence. Methods: The ITC comprises a sham-controlled trial of BT (AIR2) and two placebo-controlled trials of OM (INNOVATE; EXTRA), identified in a systematic literature review, and uses Bucher9s method. Results: Comparing the post-treatment period with BT to ongoing treatment with OM, there were no significant differences in the rate ratios (RRs) for severe exacerbations (RR of BT versus OM via OAT 0.92, p=0.67) or hospitalisations (RR 0.68; p=0.63). The rate of emergency department (ED) visits was reduced by 75% with BT versus OM and was statistically significant (RR 0.25, p=0.01). Improvements in patients9 quality of life (response on asthma quality of life questionnaire - AQLQ) were comparable (RR 1.06; p=0.59). Conclusion: BT compares favourably to potentially more-costly pharmaceutical therapies for asthma. We observe a significant decrease in Post-treatment ED visits; clinicians evaluating these two add-on treatments should consider the totality of evidence as well as patient preferences to make an informed decision. Due to potential differences of the trial populations and the indirect comparison, the analyses should be interpreted with some caution.

Recently, catheter ablation (CA) has become a therapeutic option to target focal triggers of polymorphic ventricular tachycardia and ventricular fibrillation (VF) in the setting of electrical storm (ES). This strategy was first described in subjects without organic heart disease (i.e. idiopathic VF) and subsequently in other conditions, especially in patients with ischaemic heart disease. In the majority of cases, the triggering focus originates in the ventricular Purkinje system. In patients with Brugada syndrome, besides ablation of focal trigger in the right ventricular outflow tract, modification of a substrate in this region has been described to prevent recurrences of VF. In conclusion, CA appears to be a reasonable strategy for intractable cases of ES due to focally triggered polymorphic ventricular tachycardia and VF. Therefore, early transport of the patient into the experience centre for CA should be considered since the procedure could be in some cases life-saving. Therefore, the awareness of this entity and link to the nearest expert centre are important.

A patent foramen ovale is a relatively common finding in the general population and is associated with a number of conditions, including cryptogenic stroke. In 2014, percutaneous patent foramen ovale (PFO) closure is a frequently performed procedure; the bulk of these procedures being carried out for secondary prevention of cryptogenic stroke, along with other indications, such as prevention of decompression illness, platypnoea-orthodeoxia syndrome and migraine. Of these conditions the largest body of evidence available is for cryptogenic stroke and there is ongoing debate of the benefit of PFO closure over medical therapy. This article will review the available evidence of PFO closure in each of these contexts, with a particular focus on randomised controlled trials, and endeavour to outline in whom the evidence suggests closure should be considered.

Unlike user facilities, manufacturers are directly under the jurisdiction of FDA and rely on device users to report adverse events in a timely manner to help them comply with their strict regulatory requirements. Therefore, an effective postmarket surveillance program is directly dependent on the active participation of health care professionals. However, the limitations of the spontaneous reporting system challenge the agency's and manufacturers' efforts to promptly identify, quantitate, and understand new risks associated with marketed products. Underreporting and lack of quality of information make it extremely difficult for FDA and manufacturers to determine the magnitude of the problem as well as recognize safety trends. The MedSun pilot program was developed in response to the recognition that FDA needed to augment the reporting of device-related adverse events by health care facilities. MedSun has been favorably received by participating user facilities as well as being an extremely valuable resource in helping to promote patient safety.