July’s top 10 features a video interview with Jonathan G Moss (Institute of Cardiovascular and Medical Sciences, Glasgow, UK), chief investigator of the CAVA (Central venous access devices for the delivery of systemic anticancer therapy) trial, results of which were published online in The Lancet. A meta-analysis looking at the risk of major amputation after use of paclitaxel-coated balloons (PCBs) in the peripheral arteries has attracted debate, with leading physicians propose that the methodology used needs to be carefully considered and scrutinised before these conclusions are accepted.
VIDEO: For most patients receiving systemic anticancer treatment (SACT), totally implanted ports (PORTs) are more effective and safer than both Hickman-type tunnelled catheters (Hickman) and peripherally inserted central catheters (PICCs). The CAVA trial’s results, just published online in The Lancet, recommend reshaping current guidelines and practice, so that most patients requiring chemotherapy for solid tumours receive a PORT within the UK National Health Service, foreshadowing a pivot in practice that might be “slow to start with”.
“There appears to be heightened risk of major amputation after use of paclitaxel-coated balloons [PCBs] in the peripheral arteries,” findings from a systematic review and meta-analysis of randomised controlled trials (RCTs) published in the European Journal of Vascular and Endovascular Surgery (EJVES) suggest. However, the authors clarify that the level of evidence is graded moderate, not high, due to scarce events in some studies.
A large, single-centre retrospective study has revealed the risk of acute kidney injury (AKI) following pharmacomechanical thrombolysis (PMT) for lower extremity deep vein thrombosis (DVT) is as high as 22%.
Scitech Medical has announced that it has received CE mark approval for the Embosoft microspheres for use in vascular embolization of hypervascular tumours, symptomatic uterine fibroids and prostatic arteries to relieve symptoms related to benign prostatic hyperplasia, as well as for haemostatic embolization.
Endologix announced the company’s ChEVAS (chimney endovascular aneurysm sealing) system has been granted a Breakthrough Device designation from the US Food and Drug Administration (FDA). The ChEVAS system is an investigational endovascular abdominal aortic aneurysm (AAA) sealing therapy designed to combine the Nellix 3.5 endograft with parallel visceral stents to enable treatment of patients with juxtarenal, pararenal, and suprarenal AAA.
6. Artio Medical completes enrolment of first-in-human trial investigating Amplifi vein dilation system
Artio Medical announced it has completed enrolment in its first-in-human study evaluating the Amplifi vein dilation system. In the study, five patients were treated by Adrian Ebner, head of the Cardiovascular Department at Sanatorio Italiano Hospital in Asunción, Paraguay.
7. Researchers recommend “timely interventions by specialists and guideline-based treatment” to reduce amputation rates
A population-based study from 2013 to 2015 in Germany has found that nearly one fifth of patients with peripheral arterial disease (PAD) did not receive guideline-based vascular diagnostics three months before incidence amputation. Writing online in the European Journal of Vascular and Endovascular Surgery (EJVES), authors Kristina Hagenström (University Medical Center Hamburg-Eppendorf, Hamburg, Germany) and colleagues say this “reflects an underuse of health services”.
Terumo Medical Corporation has announced the introduction of its Azur vascular plug. The addition to Terumo’s embolisation portfolio is indicated for use to reduce or block the rate of blood flow in arteries of the peripheral vasculature.
Percutaneous Deep Vein Arterialisation (pDVA) with the LimFlow System offers a cost-effective and high-value alternative to traditional therapies or amputation, according to a recent study published in the Journal of Critical Limb Ischemia.
A German claims-based cohort study has revealed that—in 13,204 patients treated with a paclitaxel-coated device for peripheral arterial disease (PAD)—mortality differences were mostly attributable to a female subgroup treated above the knee, while no statistically-significant differences were observed in male patients. These findings were recently published in the Journal of Clinical Medicine (JCM).