Preliminary real-world findings, presented at PCR London Valves (18–20 September, London, UK), indicate that the use of the cerebral protection device (TriGuard, Keystone Heart) in patients undergoing transcatheter aortic valve implantation (TAVI) is associated with a significant reduction in the number of brain lesions. The aim of the study was to evaluate the safety and effectiveness of the TriGuard embolic deflection device in protecting the brain from lesions during TAVI procedures compared to the current standard of care in the US and Europe, which is no cerebral protection during these procedures.
The Phase 3 GLAGOV (Global assessment of plaque regression with a PCSK9 antibody as measured by intravascular iltrasound) trial has met both its primary and secondary endpoints. The study is a large serial coronary intravascular imaging trial that is designed to test whether treatment with the proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor evolocumab (Repatha, Amgen) modifies atherosclerotic plaque build-up in the coronary arteries of patients already treated with optimised statin therapy. Detailed results of the trial be presented at the 2016 American Heart Association scientific sessions (12–16 November, New Orleans, USA).
Claret Medical has announced its filing of a marketing application with the FDA for clearance of the Sentinel cerebral protection system. According to a press release, Sentinel is the only device designed to protect the brain by capturing and removing debris dislodged during transcatheter aortic valve implantation (TAVI). There are currently no cerebral embolic protection technologies available in the US to protect TAVI patients from cerebral embolic events.
Following last month’s FDA approval for the expanded indication of Sapien 3 for the treatment of intermediate-risk patients with aortic stenosis, the device can now be used for intermediate-risk patients in Europe after receiving the CE mark for this indication. Data from the Sapien 3 study indicate that the device is associated with superior outcomes to surgery in intermediate-risk patients.
4Tech´s transcatheter tricuspid valve repair device (TriCinch) has been used for the first time to treat patient with tricuspid regurgitation. The procedure was performed without transoesophageal echocardiography (TEE) or general anaesthesia at the San Raffaele Hospital (Milan, Italy), took less than one hour and allowed substantial reduction of tricuspid regurgitation.
Coinciding with PCR London Valves (18-20 September, London, UK), Boston Scientific has announced it has received the CE mark for its Lotus Edge transcatheter aortic valve implantation (TAVI) system. A press release reports that compared with the previous generation valve (Lotus), the Lotus Edge iteration incorporates a more flexible, lower profile catheter designed to improve ease of use and accommodate tortuous anatomy.
Valtech Cardio will present the first-in-human data for its Cardioband Tricuspid Repair (TR) system at PCR London Valves 2016 (18–20 September, London, UK). Updated two-year follow-up results from the multicentre Cardioband Mitral study will also be presented at the meeting. Furthermore, a Valtech symposium titled—“Cardioband: clinical reality for mitral and tricuspid valve repair”—will be held on 20 September and will be chaired by Eberhard Grube (University of Bonn, Germany) and Karl-Heinz Kuck (Asklepios Klinic St Georg, Hamburg, Germany)
Caisson Interventional has announced the first successful human implants of its fully percutaneous, transvascular mitral valve implant, which is designed as a functional replacement in a diseased, damaged, or malfunctioning mitral valve. Mathew R Williams (Heart Valve Center, NYU Langone, New York, USA) and his team from the successfully implanted three patients with the Caisson transcatheter mitral valve system.
Data from a new study, BASKET-SAVAGE, indicate that patients who receive a drug-eluting stent when undergoing percutaneous coronary intervention (PCI) in a saphenous venous graft have a significantly lower rate of major adverse cardiac events (MACE) at three years than saphenous venous graft PCI patients who receive a bare metal stent. BASKET-SAVAGE was presented at the 2016 European Society of Cardiology (ESC) congress (27–31 August) during the same hot line session Rome, Italy) as NORSTENT, which showed no difference in long-term mortality between bare metal stents and drug-eluting stents in native vessel PCI.
Data from the SENTINEL pivotal IDE trial will be presented during a late-breaking trial session at the 2016 Transcatheter Cardiovascular Therapeutics (TCT) meeting (29 October–2 November, Washington, USA). The trial evaluated Claret Medical’s Sentinel cerebral protection system (CPS)—according to a press release, the only device designed to protect the brain by capturing and removing embolic debris dislodged during transcatheter aortic valve implantation (TAVI).
The Cardiovascular Research Foundation (CRF) has announced the 11 late-breaking trials and 16 first report investigations that will be presented at the 2016 Transcatheter Cardiovascular Therapeutics (TCT) 2016 scientific symposium (29 October–2 November, Washington DC, USA). The studies will examine the safety and effectiveness of minimally invasive techniques, pharmaceuticals, technologies, and devices that show potential to treat or prevent cardiovascular disease.
Marco Barbanti (Ferrarotto Hospital, University of Catania, Catania, Italy) and others report in Circulation: Cardiovascular Interventions that “redo” transcatheter aortic valve implantation (TAVI)—using TAVI vavles to treat patients with failed TAVI valves—seems to be safe and is associated with favourable acute and midterm clinical outcomes.
A study presented at the 2016 European Society of Cardiology (ESC) congress (27–31 August, Rome, Italy) indicates that functional imaging—using cardiac magnetic resonance (MR) and myocardial perfusion scintigraphy (MPS)—is associated with significantly reduced rates of unnecessary angiography than is guideline-directed care.
A team of clinical scientists at the University of Bristol (Bristol, UK) have found a new way to treat hypertension. The research study, entitled “Unilateral carotid body resection in resistant hypertension: a safety and feasibility trial,” was led by Julian Paton at the university, and Angus Nightingale, cardiology consultant at the Bristol Heart Institute, Bristol, UK, and was published recently in the Journal of American College of Cardiology: Basic to Translational Science.
European standards to prevent repeat heart attacks have been published in the European Journal of Preventive Cardiology. The standards were defined by the European Society of Cardiology (ESC).
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