Abbott made history in January when it became the first company in the world to receive market approval for a transcatheter mitral valve implantation (TMVI) device. Its Tendyne system now has a CE-mark indication for the management of patients with mitral regurgitation who cannot undergo mitral valve surgery or percutaneous edge-to-edge repair (MitraClip). TMVI devices have been in the pipeline for years but, until now, none have been commercially available. In this interview, Nicolas Dumonteil (Clinique Pasteur, Toulouse, France) talks to Cardiovascular News about what the approval of Tendyne means for the management of patients with mitral regurgitation.
The early months of 2020 have seen the emergence of new technologies in the intraoperative navigation space. Here, Vascular News considers Philips’ Fiber Optic RealShape (FORS) technology and Centerline Biomedical’s IntraOperative Positioning System (IOPS)—data on which have been presented at various meetings in recent months.
Reflow Medical has announced that they have received US Food and Drug Administration (FDA) clearance for an expanded indication for the Wingman crossing catheter after completing the Wing-IT clinical trial. The Wingman catheter crosses peripheral chronic total occlusions (CTOs) using an extendable bevelled tip that creates a channel to help penetrate, or cross, the occlusion with a guidewire, enabling further treatment of the lesion with therapeutic devices.
CryoLife has announced that it has received CE mark for the E-vita Open NEO, a hybrid stent graft system for the treatment of aortic arch disease.
Paclitaxel drug coated balloons (DCB) for percutaneous treatment of coronary artery disease (CAD) are not associated with increased mortality, and longer term evaluation suggests a trend towards lower mortality compared to control therapies. The authors of a meta-analysis of randomised controlled trials, published in the Journal of the American College of Cardiology, say the findings are “in contrast to reported experience with paclitaxel-coated devices for superficial femoral artery interventions” and that the data “reassure the safety of these devices when used in coronary arteries”.
Endotronix has announced the enrollment of the first two patients in the PROACTIVE-HF trial. The trial is a premarket investigational device exempt (IDE) study evaluating the safety and efficacy of the Cordella pulmonary artery pressure sensor system (Cordella sensor) for the treatment of heart failure. The first two patients were successfully implanted with the Cordella Sensor by Navin Kapur and Michael Kiernan (both Tufts Medical Center, Boston, USA) and Liviu Klein (University of California San Francisco, San Francisco, USA).
While drug-coated balloons (DCBs) have been “consistently efficacious” across various studies, the mortality signal has not, Peter Schneider (University of California San Francisco, San Francisco, USA) noted at this year’s Leipzig Interventional Course (LINC 2020; 28–31 January, Leipzig, Germany). He concluded that this is partly because of ascertainment bias, but also “probably” because of treatment bias across different geographies.
Cerebrospinal fluid (CSF) drainage is a key component in the treatment of spinal cord injury but the evidence that prophylactic drainage decreases such injury during endovascular repair (EVAR) is “at best weak,” Gustavo Oderich (Mayo Clinic, Rochester, USA) told this year’s Critical Issues America annual meeting (7–8 February, Miami, USA).
CryoLife has announced it has received CE mark for the On-X Ascending Aortic Prosthesis (AAP), allowing resumed distribution in the European Union (EU). The On-X AAP is indicated for the treatment of diseased, damaged or malfunctioning native or prosthetic heart valves in the aortic position involving an ascending aortic aneurysm. These associated aortic root diseases coexist in as many as 10% of all aortic valve replacements.
Biotronik has announced three-year data from the Bioflow-V trial, which was presented recently at the 2020 Cardiovascular Research Technologies (CRT) conference. The three-year follow-up data demonstrates consistently lower clinical event rates and improvement in patient outcomes, reinforcing the differentiation of the Orsiro coronary drug-eluting stent (DES)—the first and only ultrathin strut DES to outperform Xience. Orsiro received FDA approval in 2019 and has been used to treat more than two million patients worldwide to date. The study results have been simultaneously published in JACC: Cardiovascular Interventions.
February 2020 brings another paclitaxel device meta-analysis of randomised controlled trials in chronic limb-threatening ischaemia (CLTI) patients. Krystal Dinh (Westmead Hospital, Sydney, Australia) et alreport online ahead of print that the risk of all-cause mortality after treatment with paclitaxel-coated devices versus uncoated controls in patients with CLTI in the Journal of Endovascular Therapy (JEVT) very differently than did Katsanos and colleagues earlier this year. In fact, Dinh et al, due to the clear benefit and no suggestion of a link between the use of paclitaxel-coated devices and mortality, “recommend their continued use in this high-risk patient population”.
Robert Shahverdyan, head of the Vascular Access Center at Asklepios Klinik Barmbek, Hamburg, Germany, has recently published a retrospective analysis of his first 32 consecutive radiocephalic (forearm) VasQ External Support procedures in the Journal of Vascular Access. The paper demonstrated that using VasQ as standard of care for radiocephalic fistulas resulted in a significant improvement in his centre’s primary fistula failure and longer-term secondary patency rates with less repeat interventions when compared to historical controls.
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