Alucent Biomedical has received US Food and Drug Administration (FDA) approval to proceed with a phase 1 clinical trial to evaluate the safety and efficacy of its Natural Vascular Scaffolding (NVS) technology. The therapy is designed to treat peripheral arterial disease (PAD) of the lower extremities, a condition that affects over 200 million people worldwide.

Abbott has announced that the US Food and Drug Administration (FDA) has approved a first-of-its-kind clinical trial that will compare the effectiveness of Abbott’s MitraClip device to open heart mitral valve surgical repair in people with primary mitral regurgitation (MR) who are eligible for open-heart surgery. If successful, the trial has the potential to expand treatment options from the current indication of patients at prohibitive risk for surgery to also include patients at moderate risk.

In the area of lower limb amputation, core outcome sets “should be adopted on all future studies recruiting patients” said Graeme Ambler (University of Bristol, Bristol, UK), who was speaking at the annual meeting of the Vascular Societies’ Annual Scientific Meeting (VSASM; 27–29 November 2019, Manchester, UK). Developed in a four-stage process, Ambler discussed how the core outcome sets to address a range of concerns involved in the care of amputees.

Serena Auñón-Chancellor, clinical associate professor of medicine at Louisiana State University Health, New Orleans School of Medicine’s branch campus, in Baton Rouge, USA, is the lead author of a paper which describes a previously unrecognised risk of spaceflight discovered during a study of astronauts involved in long-duration missions.

Five-year data from the NOBLE trial have confirmed its earlier findings that in patients with unprotected left main coronary disease the risk of major adverse cardiac or cerebrovascular events (MACCE) is higher with percutaneous coronary intervention (PCI) than with coronary artery bypass graft (CABG); the mortality risk was similar for both procedures. Published in the Lancet, the findings come in the wake of an ongoing controversy surrounding the interpretation of data from EXCEL, which also compared CABG and PCI in left main disease.

The TASTE and TOTAL studies suggested that routine thombus aspiration in patients undergoing percutaneous coronary intervention (PCI) did not provide mortality benefit and may increase the risk of stroke. However, a new study (CHEETAH) is evaluating whether a next-generation aspiration catheter could lead to improved outcomes. S Jay Mathews (Manatee Memorial Hospital, Bradenton, USA), principal investigator of the study, talks to Cardiovascular News about why thrombus aspiration still has the potential to be an effective tool in PCI.

Preprocedural administration of an oral colchicine load does not reduce the risk of myocardial injury or 30-day major adverse cardiovascular events (MACE) in patients undergoing percutaneous coronary intervention (PCI), according to findings from the COLCHICINE-PCI (Effects of acute colchicine administration prior to percutaneous coronary intervention) clinical trial. However, the study concluded that colchicine could prevent vascular inflammation during an acute injury.

Daiichi Sankyo Europe has announced outcomes from an observational study in mainly caucasian atrial fibrillation (AF) patients being treated with the anti-coagulation drug edoxaban (Lixiana).

Data from the CAP and CAP2 registries—which contain the longest and largest follow-up of patients—add to previous evidence that left atrial appendage closure (LAAC) with Watchman (Boston Scientific) is a safe and effective alternative to long-term anticoagulation in patients with atrial fibrillation. Furthermore, the results show the lowest rate of haemorrhagic stroke observed in this patient population.

The US Food and Drug Administration has granted Breakthrough Device designation to the digital health and artificial intelligence (AI) company Ekofor an echocardiogram (ECG)-based algorithm to help identify induced Left Ventricular Ejection Fraction (LVEF).

The largest trial to date to compare revascularisation with a conservative strategy in patients with stable ischaemic heart disease has found no additional benefit a median of three years after the procedure.