Final results from the RESPECT trial found that percutaneously closing a patent foramen ovale (PFO) using the Amplatzer PFO Occluder (St Jude Medical) was superior to medical management in the prevention of recurrent ischaemic stroke in patients who previously had a cryptogenic stroke.
A study in JACC: Cardiovascular Interventions indicates that patients who require a pacemaker after undergoing transcatheter aortic valve implantation (TAVI) often have worse outcomes than those who did not need a pacemaker. It shows that the risks are both short- and long-term and include lengthier hospital and intensive care unit stays as well as a greater risk of death.
Pfizer is to discontinue the global clinical development program for bococizumab—its investigational PCSK9 inhibitor. According to a press release, the totality of clinical information now available for bococizumab—taken together with the evolving treatment and market landscape for lipid-lowering agents—indicates that the drug is not likely to provide value to patients, physicians, or shareholders. As a result, Pfizer has decided to discontinue the development programme, including the two ongoing cardiovascular outcome studies.
Svelte Medical Systems has announced the start of enrolment in the DIRECT III post-market registry study. DIRECT III is an “all-comer” study in Europe undertaken to evaluate the procedural efficiency and long-term safety of the Slender IDS, which a press release reports is the first advance in stent delivery since the rapid-exchange catheter. According to the press release, the device is the world’s lowest profile drug-eluting stent—reducing the catheter size necessary to perform percutaneous coronary intervention (PCI) and facilitating transradial interventions in more patients.
The National Institute of Health and Care Excellence (NICE) has published a final appraisal determination that states dual antiplatelet therapy with ticagrelor 60mg (Brilique, AstraZeneca) and aspirin is a potential option for patients who have had a myocardial infarction and are at high risk of a further event. It advises that treatment should be stopped when clinically indicated or at a maximum of three years.
Mitralign presented 30-day data from the SCOUT I study, which designed to evaluate the performance of its Trialign system for tricuspid repair, at the 2016 Transcatheter Cardiovascular Therapeutics (TCT) meeting (29 October–2 November, Washington, DC, USA). The data, which were presented by SCOUT I principal investigator Rebecca T Hahn (Center for Interventional Vascular Therapy, Columbia University Medical Center, New York, USA), showed positive data from the study’s first 15 patient cohort.
Data presented at the 2016 Transcatheter Cardiovascular Therapeutics (TCT) meeting (29 October–2 November, Washington, DC, USA) indicate that intermediate-risk patients who undergo transcatheter aortic valve implantation (TAVI) with a Sapien XT or Sapien 3 device (Edwards Lifesciences) have significantly better quality of life at 30 days compared with those who undergo surgical aortic valve replacement. However, according to these data, there were no significant differences in quality of life between TAVI and surgery patients at one year.
Neovasc has announced today its notable presentations at the 2016 Transcatheter Cardiovascular Therapeutics (TCT) meeting (29 October–2 November, Washington, DC, USA). On 31 October, Anson Cheung (St Paul’s hospital, Vancouver, Canada) presented an update on the ongoing Tiara programme, discussing the clinical data to date for the 19 patients treated with the Neovasc Tiara transcatheter mitral valve implantation (TMVI) valve. The 30-day survival rate for these 19 patients is 84%. Overall, the data presented was very encouraging, in this very sick cohort of patients treated with Tiara.
Medtronic has unveiled new clinical data that shows that patients treated with its self-expanding CoreValve Evolut R transcatheter aortic valve implantation (TAVI) device continued to experience excellent clinical outcomes at one year. Presented at the 2016 Transcatheter Cardiovascular Therapeutics (TCT) meeting (29 October–2 November, Washington, DC, USA), the Evolut US investigational device exemption (IDE) study showed that 241 patients deemed extreme and high risk with symptomatic severe aortic stenosis had high rates of survival (91.4%) and low rates of disabling stroke (5.1 %) at one year.
UK charity Heart Valve Voice has launched a report—Towards a Heart Healthy Future: a 2020 Vision for Heart Valve Disease’—that sets out recommendations to prioritise the development of National Institute for Health and Care Excellence (NICE) guidelines to ensure that people living with heart valve disease receive a timely diagnosis and have equal opportunity to access effective and appropriate treatment for the condition, regardless of where they live.
Six-month clinical data for Elixir Medical’s bioresorbable scaffold (Desolve) were presented at the 2016 Transcatheter Cardiovascular Therapeutics (TCT) meeting (29 October–2 November, Washington, DC, USA). These data, of the first 25 patients, indicate that at six months, the rate of late lumen loss was 0.18 ± 0.29 mm (“excellent” according to a press release), no cases of scaffold thrombosis, and no (0%) clinically-driven major adverse cardiac events. Imaging results by intravascular ultrasound (IVUS) demonstrated low neointimal volume obstruction of 5%.
At the 2016 Transcatheter Cardiovascular Therapeutics (TCT) meeting (29 October–2 November, Washington, DC, USA), Cardiovascular Systems debuted the design of its new ECLIPSE clinical trial. The trial will compare the company’s Diamondback 360 coronary orbital atherectomy system with conventional angioplasty, including specialty balloons, for vessel preparation prior to drug-eluting stent implantation.
Arterys has received 510(k) clearance from the FDA for its Arterys Software. This clearance allows the Arterys product to be used in clinical settings for the quantification of cardiac flow, which includes 4D flow and 2D phase contrast workflows, and cardiac function measurements. The product is deigned to seamlessly integrate into clinical practice to provide comprehensive, simple and quick cardiac magnetic resonance (MR) imaging. Previously, the Arterys Software received FDA clearance for its 4D Flow visualisation feature.
Arrhythmia Alliance, the UK-based heart rhythm charity, is calling on NHS England to reconsider a programme that it says will mean the “hundreds” of patients with atrial fibrillation in England who cannot take oral anticoagulation will be left without protection against stroke. It notes that under the commissioning through evaluation programme, after the end of November, NHS England will no longer provide funding for patients to undergo percutaneous left atrial appendage occlusion.
A study published, as a research letter, in the Journal of the American College of Cardiology indicates that smartphone communication among medical teams at different hospitals can significantly reduce the time it takes for myocardial infarction patients to get lifesaving treatment after a hospital transfer. It showed that patients with ST-segment elevated myocardial infarction (STEMI) needing a hospital transfer underwent percutaneous coronary intervention (PCI)—on average—27 minutes faster when their medical teams used a smartphone app-based social network system (SNS) to coordinate the hospital transfer than patients whose medical teams communicated with a non-smartphone based STEMI hotline.
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