The three-year results of the ISAR-DESIRE 3 (Intracoronary stenting and angiographic results: drug eluting stent in-stent restenosis: 3 treatment approaches) study, as reported in JACC: Cardiovascular Interventions, suggest that the use of paclitaxel-coated balloons to treat patients with drug-eluting stent restenosis has similar long-term safety and efficacy to that of using paclitaxel-eluting stents in this indication. The study also shows that the superiority of paclitaxel-coated balloons over balloon angioplasty in this setting is maintained at three years.
Biotectix has announced that its Amplicoat electro-conductive polymer coating has been licensed by Acutus Medical for use on the company’s real-time 3D Cardiac Chamber Imaging and Dipole Density Mapping system.
New results from two clinical studies, both of which were presented at EuroPCR (19–22 May, Paris, France) provide further support to the use of St Jude Medical’s fractional flow reserve (FFR) technology to optimise percutaneous coronary intervention (PCI) procedures. According to a company press release, the results—from the 15-year follow-up of DEFER study and from the CONTRAST study—contribute to the growing body of evidence supporting FFR as a valuable and important decision-making tool for physicians.
CardiAQ Valve Technologies has received FDA investigational device exemption approval for a US early feasibility study of its second-generation transfemoral and transapical transcatheter mitral valve implantation system. With this study approval, a company press release reports, US clinical investigators will now be able to commence assessing the feasibility and safety of the two CardiAQ Systems in preparation for a future pivotal study.
Patients with On-X aortic heart valves may be able to reduce their regular blood-thinning medication regimen, thanks to an expanded labelling claim granted by the US Food and Drug Administration (FDA) to On-X Life Technologies.
Direct Flow Medical has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to broaden its SALUS trial, including the addition of high risk patients and randomisation against a commercial device, the Medtronic CoreValve.
Maquet Cardiovascular USA has announced publication of a manuscript comparing the clinical and economic impact of percutaneous ventricular assist devices (pVAD) with intraaortic balloon pumps for high-risk patients undergoing percutaneous coronary intervention. The paper was published in the Journal of Invasive Cardiology.
A meta-analysis published in Circulation: Cardiovascular Interventions indicates that the prevalence of non-access site bleeding after percutaneous coronary intervention (PCI) is similar to that of access-site bleeding. However, it also shows that while both are associated with adverse outcomes, the former is associated with a significantly worse prognosis than is the latter.
Tim P van de Hoef (Academic Center, AMC Heartcenter, Amsterdam, The Netherlands) and others report in EuroIntervention that pressure-controlled intermittent coronary sinus occlusion (PICSO) may be associated with enhanced myocardial recovery in patients with ST-segment elevation myocardial infarction (STEMI) who have undergone percutaneous coronary intervention (PCI). However, they also report that the feasibility of the system is limited.
Hospitals in the Midwest of the USA were more likely than others to refer patients for guideline-recommended cardiac rehabilitation following angioplasty, possibly because more rehab programs are available in the region, according to original research and an accompanying editorial published in the Journal of the American College of Cardiology (JACC).
In the last decade, substantial effort has been made to ease the delivery of drug-coated balloons—especially because we now understand that device delivery does not automatically warrant drug delivery. With the first-generation drug-coated balloons, we often had to deal with devices that had paclitaxel “sprinkled on”. While we may have been able to deliver a device to the lesion, we were not always sure how much drug we actually delivered. Fortunately, because of this problem, there have been huge improvements to drug-coated balloon technology. However, certain “tricks” are needed to achieve optimum results with drug-coated balloons.
There is increasing concern about the damaging effects of radiation exposure to the operating room staff during interventional procedures, particularly as a recent study found that the majority of interventional cardiologists with brain tumours have left-side tumours (the side most often exposed to radiation). Ryan Madder, an interventional cardiologist at the Frederik Meijer Heart & Vascular Institute (Spectrum Health, Grand Rapids, Michigan, USA) explains why he believes a robotic system (CorPath, Corindus Vascular Robotics) for performing percutaneous coronary intervention (PCI) may help to reduce radiation exposure.
Last year, the GHOST-EU registry indicated that the rate of scaffold thrombosis with the bioresorbable vascular scaffold (Absorb, Abbott Vascular) was “not negilible”. This led to concerns about the risk of this potentially fatal complication with the device. However, as technological refinements continue, bioresorbable scaffolds may yet become a workhorse stent of percutaneous coronary intervention (PCI).
At the 64th Annual Scientific Session & Expo of the American College of Cardiology (ACC), (14-16 March, San Diego, USA) Siemens Healthcare offered solutions for sustainable cardiovascular care that help ensure “more cardiology, less heartache”—the theme of this year’s booth. Siemens offered a portfolio of systems and support solutions ranging from imaging modalities to information technology to in vitro diagnostics,.
Favourable outcomes from the initial commercial experience of transcatheter mitral valve repair with MitraClip in the USA were presented during the late-breaking clinical trial session at the American College of Cardiology (ACC)’s 64th Annual Meeting (14–16 March, San Diego, USA).
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