US national hospital- and surgeon-level inverse volume–outcome associations were observed for 30-day and one-year mortality after mitral valve surgery for primary mitral regurgitation, according to a study published in JAMA Cardiology. Authors Vinay Badhwar (Department of Cardiovascular and Thoracic...
Patients who have trouble sleeping after heart bypass surgery should go for a morning walk, according to research presented on ACNAP Essentials 4 You, a scientific platform of the European Society of Cardiology (ESC). In a press release from the...
US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval has been granted for the Carag Bioresorbable Septal Occluder (CBSO). The CE-marked CBSO is a transcatheter septal occluder with a bioresorbable, metal-free framework. Carag's first US trial is designed...
Mid-term data continue to show non-inferiority of resting instantaneous wave-free ratio (iFR) when tested against hyperaemic fractional flow reserve (FFR), said Javier Escaned (Hospital Clinico San Carlos, Madrid, Spain) who reported a pooled, nearly 4,500 patient-level analysis of DEFINE...
A subanalysis of the Onyx One study found that cardiac death was significantly higher in patients who received single antiplatelet therapy with a P2Y12 inhibitor following percutaneous coronary intervention (PCI) than those who received single antiplatelet therapy with aspirin....
Left atrial appendage occlusion (LAAO) using the Amplatzer Amulet (Abbott) device has a high implant success rate and a low procedural complication rate in a population at high risk of stroke and major bleeding, one-year outcomes from a roll-in...
MedAlliance has been awarded CE mark for the Selution SLR 014 percutaneous transluminal coronary angioplasty (PTCA), a novel sirolimus drug eluting balloon (DEB), for the treatment of coronary artery disease. This includes indications for both de-novo lesions and in-stent...
BioCardia has announced that it has resumed cases in the CardiAMP Heart Failure Trial. The first patient procedure completed since elective procedures were paused due to COVID-19 took place at Morton Plant Hospital in Clearwater, Florida, USA, this month....
The feasibility, safety, and efficiency of transcatheter aortic valve implantation (TAVI) using a self-expanding platform in bicuspid aortic valves has been confirmed by the BIVOLUT X registry, Didier Tchétché (Clinique Pasteur, Toulouse, France) told PCR e-Course 2020 (25–27 June)....
According to a press release, one-year total population clinical outcome data from e-ULTIMASTER—the world’s largest registry of patients treated with a drug-eluting stent—can reinforce “the trust cardiologists worldwide have in the Ultimaster drug-eluting stent (Terumo)” while providing valuable insight...
The FABOLUS FASTER trial, which was presented at PCR e-Course 2020 and simultaneously published in Circulation, shows that cangrelor provides inferior inhibitor of platelet aggregation (IPA) to tirofiban in ST-segment elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary...
Felice Gragnano (Inselspital, Bern University Hospital, Bern, Switzerland) outlined at PCR e-Course 2020 the initial results with the CoFlo system (CorFlow Therapeutics). He explained that the system was “safe, easy to use”, follows percutaneous coronary intervention (PCI) workflow and...
Left atrial appendage occlusion (LAAO) improves clinical outcomes including ischaemic stroke, major bleeding and all-cause mortality, in atrial fibrillation (AF) patients with a high risk of stroke and major bleeding, compared to the use of novel oral anticoagulants (NOACs)....
Sripal Bangalore (New York University Grossman School of Medicine, New York, USA) presented the results of a late-breaking meta-analysis of randomised trials (including the recently published ISCHEMIA and ISCHEMIA-CKD) that compared routine revascularisation with an initial conservative strategy at...
One-year results from the TRILUMINATE study show that TriClip (Abbott) transcatheter therapy for symptomatic moderate or greater tricuspid regurgitation (TR) results in durable reduction of regurgitation, with few major adverse events, and improvement in functional and clinical outcomes. Phillip Lurz...
Clinical and imaging results at 12 months for the DynamX Novolimus-Eluting Coronary Bioadaptor system (Elixir Medical) have demonstrated “excellent” safety and efficacy, a late-breaking trial session at the PCR e-Course 2020 event (25–27 June) has been told. Stefan Verheye (Antwerp...
A systematic two-stent approach in complex coronary bifurcation lesions is associated with a significantly greater improvement in clinical outcomes at one year than provisional stenting, according to the DEFINITION II study, presented at a late-breaking trial session at the...
Patients who crossed over from the sham control arm of the RADIANCE-HTN SOLO trial to the renal denervation arm after 12 months of elevated blood pressure had decreased daytime ambulatory systolic blood pressure at both two and six months...
Full one-year follow-up from the Evolut Low Risk trial has upheld earlier findings from the study, demonstrating that transcatheter aortic valve implantation (TAVI) is non-inferior to surgical aortic valve replacement (SAVR) for all-cause mortality or disabling stroke at two...
Long-term clinical outcomes, including mortality, following an aortic valve-in-valve procedure may be affected by the size of the original degenerated bioprosthetic valve, according to findings from the Valve-in-Valve International Data (VIVID) Registry which were released at the PCR e-Course...
Use of the transseptal Evoque transmitral valve replacement (TMVR) system (Edwards Lifesciences) has been shown to be feasible in a first-in-human experience, a hotline session at PCR e-Course 2020 (25-27 June) has been told. The findings, presented by John...
A comprehensive evaluation of mitral valve-in-valve (ViV) and valve-in-ring (ViR) procedures has found that residual mitral stenosis and/or mitral regurgitation were “relatively common”, and that both were associated with a need for repeat valve replacement. Significant residual mitral regurgitation...
The American College of Cardiology (ACC) and Society for Vascular Surgery (SVS) are collaborating on a single vascular registry, according to a press release, to harness the strengths of both organisations in improving care and outcomes of patients with...
Miracor Medical has announced the award of the CE mark for its latest generation of PiCSO Impulse Catheter and PiCSO Impulse Console, which is indicated for the treatment of anterior STEMI patients. It says the new system features improvements...
Medtronic has been awarded CE mark for the use of the Evolut transcatheter aortic valve implantation (TAVI) system for patients with severe native aortic stenosis who are at low surgical risk. The Evolut TAVI platform has also received a...
Voice analysis by a smartphone app can identify lung congestion in heart failure patients, allowing early intervention before their condition deteriorates, a study presented on HFA Discoveries, a scientific platform of the European Society of Cardiology (ESC) has found. “Speech...
Proximo Medical has announced a partnership with digital health company Coala Life in select US markets. According to a press release from Proximo Medical, it provides a business acceleration solution to addresses medical device commercialisation challenges among startup and...
Abiomed has launched a virtual physician education programme, CAMP PCI (Coronary artery and myocardial protected percutaneous coronary intervention), to improve high-risk PCI patient outcomes. A press release from the company outlines that the digital education platform was developed to...
Trainee interventional cardiologists have raised concerns that reductions in patient numbers undergoing cardiac catheterisation procedures during the pandemic is impeding their professional development.  Sabeeda Kadavath (University of Arkansas for Medical Sciences, Little Rock, USA) and colleagues from the Cardiovascular Fellows...
Telemedicine has come into its own during the pandemic. Sameer Mehta details the STEMI treatment strategy of the Latin America telemedicine infarct network (LATIN), and shares lessons learnt. The response to the coronavirus pandemic has led to seismic developments around...
Blue Sail Medical has completed the acquisition of Swiss based company NVT AG. The closure of the deal was publicly announced on the Shenzhen Stock Exchange on the 9 June 2020, and a press release from Blue Sail Medical...
MicroPort has been given CE approval for its PathBuilder Steerable Introducer, PathBuilder Transseptal Guiding Introducer and PathBuilder Transseptal Needle. A company statement outlines that the PathBuilder range of products helps to build a pathway from the femoral vein into atrium,...
The British Heart Foundation (BHF) is calling on the Government and the NHS to urgently address the immediate needs of heart and circulatory patients who have had care postponed during the coronavirus pandemic. The charity made its statement after...
Abiomed has received investigational device exemption (IDE) from the US Food and Drug Administration (FDA) for an early feasibility study with a first-in-human trial of Impella ECP (expandable cardiac power), a 9 French (Fr) heart pump. It will be...
Biosensors International Group has announced the appointment of Keith G Oldroyd to the post of chief medical officer.  A press release from the company details that Oldroyd was a consultant interventional cardiologist at the West of Scotland Regional Heart...
Collaboration between cardiothoracic and vascular surgeons is key to achieving success in aortic arch interventions, a session at CX 2020 LIVE has concluded. Speakers presenting in a session entitled Aortic Arch Consensus and Stroke from Thoracic Endovascular Procedures (STEP)...
Medtronic has received the CE mark for a one-month dual antiplatelet therapy (DAPT) indication for high bleeding risk patients implanted with the Resolute Onyx drug-eluting stent. A press release reports that for high bleeding risk patients, this new, first-of-its-kind...
Clinical and echocardiographic outcomes at 30 days and one year were similar between patients with bicuspid and tricuspid aortic stenosis following transcatheter aortic valve implantation (TAVI) with a self-expanding valve in a recent analysis from the TVT Registry. Researchers...

Vinod Thourani

Mitral and tricuspid valve technologies, aortic valve replacement, and the value of the heart team are among the issues that Vinod Thourani (Marcus Valve Center, Piedmont Heart Institute, Atlanta, USA) tackles, as he reflects on his career for Cardiovascular...
The American College of Cardiology (ACC) is to host a weekly virtual meeting— the Summer COVID-19 Education Series—to provide the healthcare community with actionable insights and solutions that will address key clinical and operational concerns and challenges during the...
The European Society of Cardiology (ESC) has announced that the HFA Discoveries online event will be running six days of live sessions from 5 to 19 June, looking at prevention and treatment strategies in heart failure. The sessions will...
COVID-19 linked to a near 40% drop in STEMI cases in US cath labs Survey provides insights into how to tackle COVID-19 elective backlog Profile of Vinod Thourani Transcatheter mitral valve implantation
COVID-19 linked to a near 40% drop in STEMI cases in US cath labs Survey provides insights into how to tackle COVID-19 elective backlog Profile of Vinod Thourani Transcatheter mitral valve implantation
A Bayesian analysis of EXCEL and other randomised controlled trials comparing coronary artery bypass graft (CABG) and percutaneous coronary intervention (PCI) in left main coronary artery disease (LMCAD) suggests that PCI was associated with inferior long-term results for all...
LivaNova have presented the first data from the Perceval sutureless implant versus standard-aortic valve replacement (PERSIST-AVR) clinical study at the 100th Annual Meeting of the American Association of Thoracic Surgery (AATS), which took place online 22–23 May 2020. A...
CeloNova BioSciences has announced that it has successfully completed enrolment into the COBRA REDUCE randomised controlled trial to evaluate the safety and efficacy of the Cobra PzF nanocoated coronary stent (NCS) in percutaneous coronary intervention (PCI) with 14-day dual...
The annual Transcatheter Cardiovascular Therapeutics (TCT) meeting has become the latest in a long line of conferences this year that has had to convert their physical meeting into a virtual one. The meeting, which was to be held between...
The Society for Cardiovascular Angiography and Interventions (SCAI) and the Canadian Association of Interventional Cardiology (CAIC) have launched a new registry—NACMI (North American COVID-19 ST-segment elevation myocardial infarction registry)—to better understand the presentation of ST-segment elevation in patients with...
According to research published in JACC: Heart Failure, patients with heart failure who experience low health literacy are at an increased risk of hospitalisation and mortality. A press release reports that this finding has significant clinical and public health...
A press release reports that the Society of Cardiovascular Computed Tomography (SCCT) will present the 2020 Gold Medal Award to John Lesser (Minneapolis Heart Institute/Abbott Northwestern Hospital, Minneapolis, USA) at the SCCT 15th Annual Scientific Virtual Meeting on July...
According to a survey published in the Journal of Occupational and Environmental Medicine, NHS staff working during the pandemic are showing signs of mild depression. The survey also indicates that a large majority (81%) of workers fear contracting COVID-19...
In JACC: Heart Failure, Mathias Orban (Medizinische Klinik und Poliklinik I, Klinikum der Universität München, Munich, Germany) and colleagues report that transcatheter tricuspid valve repair for the management of severe tricuspid regurgitation is associated with reduced heart failure hospitalisations...
Several studies have suggested that, across all countries, COVID-19 mortality is higher in people of colour. Keith C Ferdinand (Tulane University School of Medicine, New Orleans, USA) and his colleague, Samar Nasser, recently wrote in the Journal of the...
Data from more than 1,000 patients presented during the virtual Society for Cardiovascular Angiography and Interventions (SCAI) 2020 Scientific Sessions (14–16 May, Eastern Time) demonstrates Impella (Abiomed) reduced in-hospital mortality when placed before a non-emergent percutaneous coronary intervention (PCI)...
Medtronic has that announced Jeffrey J Popma (Harvard Medical School; Beth Israel Deaconess Medical Center, Boston, USA) will join the company as vice president and chief medical officer supporting the coronary, renal denervation, and structural heart businesses. A press...
Edwards Lifesciences has received the CE mark for the PASCAL transcatheter valve repair system for the treatment of European patients with tricuspid regurgitation. A press release reports that the PASCAL system is indicated in Europe for the percutaneous reconstruction of...
A study published in Circulation: Cardiovascular Interventions shows that robotic percutaneous coronary intervention with the CorPath GRX system (Corindus Vascular Robotics, Siemens Healthineers) reduces patient exposure to radiation by 20% compared to manual PCI with no increase in fluoroscopy...
A late-breaking clinical trial presented at the virtual Society for Cardiovascular Angiography and Interventions (SCAI) 2020 Scientific Sessions (14–16 May, Eastern Time) demonstrated strong long-term haemodynamic and safety outcomes for the Melody transcatheter pulmonary valve (Medtronic). Additionally, results from...
Weili Xu (Department of Epidemiology and Biostatistics, School of Public Health, Tianjin Medical University, Tianjin, China) and colleagues report in the Journal of the American College of Cardiology that people with a higher risk of developing cardiovascular disease have...
A study presented at the virtual Society for Cardiovascular Angiography and Interventions (SCAI) 2020 Scientific Sessions (14–16 May, Eastern Time) has found that a non-fasting strategy prior to cardiac catheterisation is non-inferior to a traditional fasting strategy in terms...
A study presented yesterday at the virtual Society for Cardiovascular Angiography and Interventions (SCAI) 2020 Scientific Sessions (14–16 May, Eastern Time) indicates that the addition of icosapent ethyl to statin therapy in patients with elevated triglycerides and increased cardiovascular...
A novel, groundbreaking trial has examined the viability of telemedicine for remote guidance of a population-based ST-segment elevation myocardial infarction (STEMI) programme reaching more than 100 million patients. The study, presented as late-breaking science during the SCAI 2020 Scientific...
PCR has announced a new online initiative—e-Course 2020—that is to run online from 25 June 27 June. According to the PCR website, the course “will be sharing the latest scientific news and best practice for the full benefit of...
The Society for Cardiovascular Angiography and Interventions (SCAI) has published a position statement addressing optimal percutaneous coronary intervention (PCI) treatment of patients with complex coronary artery disease. The position statement was presented today during the SCAI 2020 Scientific Sessions...
MedAlliance has announced the award of its second CE mark: Selution SLR 014 percutaneous transluminal angioplasty balloon, which is a novel sirolimus-eluting balloon for the treatment of coronary arterial disease. This includes indications for both de novo lesions as...
A survey published in The Annals of Thoracic Surgery find that despite being in an intensely demanding and competitive specialty, cardiothoracic surgeons report being extremely satisfied with their jobs—more so than ever before. Administered by The Society of Thoracic...
The American College of Cardiology (ACC) is start to collecting COVID-19 data through the NCDR Chest Pain-MI and CathPCI registries with the aim of capturing the relationship between COVID-19 and heart disease and maximise data on the cardiac impact...
Royal Philips has announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) to market a wide range of its ultrasound solutions for the management of COVID-19-related cardiac and lung complications. Handheld and portable ultrasound...
The US Food and Drug Administration (FDA) has expedited clearance of an update to software from Caption Health, a medical artificial intelligence (AI) company, that is designed to aid frontline healthcare workers to perform diagnostic-quality cardiac ultrasounds. Following a...
Two-year data from the BIONYX trial show that all-comer patients who underwent percutaneous coronary intervention (PCI) with Resolute Onyx (Medtronic) had a similar rate of target vessel failure to those who underwent PCI with Orsiro (Biotronik). Additionally, unlike the...
According to a statement, Heart Valve Voice US is “deeply concerned” that the patient perspective was omitted from the recent guidance on resuming cardiovascular procedures published the Journal of the American College of Cardiology. The guidance was endorsed by...
A joint UK-US research team is applying an artificial intelligence (AI) system to map for the first time how the COVID-19 virus attacks the heart with such deadly impact. This week, British health-tech company Ultromics and Mayo Clinic in...
BioCardia has announced data from a recent animal study performed that, according to a press release, demonstrate meaningful improvements in heart function for patients treated with its allogenic neurokinin 1 receptor positive mesenchymal stem cell (NK1R+ MSC) programme for...
Corresponding author Valentin Fuster (Mount Sinai Heart, New York, USA) and colleagues report in the Journal of the American College of Cardiology that hospitalised COVID-19 patients treated with anticoagulants had improved outcomes both in and out of the intensive...
Boston Scientific has announced positive 12-month results from the PINNACLE FLX clinical trial assessing the safety and efficacy of the next-generation WATCHMAN FLX Left Atrial Appendage Closure (LAAC) Device for patients with non-valvular atrial fibrillation (NVAF). Presented as a...
  A BIBA MedTech Insights survey indicates that 50% of centres performing structural heart procedures believe that they will need to increase the number of operating days per week to manage the elective cases that have been put on hold...
Vishal Luther (final year cardiology registrar/ Electrophysiology fellow, Imperial College Healthcare NHS trust, London NW Thames Deanery, UK) and his colleague Balrik Kailey (cardiology registrar) have organised a programme of webinars—CardioWebinars during COVID19—to help cardiology fellows continue education over...
The European Society of Cardiology (ESC) is, for the first time in its 70-year history, to hold its annual meeting (ESC Congress) 100% online. A press release states that the move follows an announcement from the Dutch government banning...
According to recently presented TICO trial data, a press release reports, patients with acute coronary syndrome treated with the Orsiro drug-eluting stent (Biotronik) benefit from stopping aspirin three months after stenting and continuing only with ticagrelor monotherapy. Yang Soo...
ZOLL Medical has received CE Mark approval to market and distribute its SuperSaturated oxygen (SSO2) therapy system in Europe. A press release reports that SSO2 therapy provides interventional cardiologists with the first and only clinically proven treatment beyond percutaneous...
The Society of Cardiovascular Computed Tomography (SCCT) has announced plans to hold its annual scientific meeting in a virtual format. The in-person meeting, which was to take place in Seattle (USA), was cancelled because of coronavirus-related restrictions on travel...
The American College of Cardiology (ACC) and other North American cardiology societies, including the Canadian Association of Interventional Cardiology (CAIC), have issued guidance on ethically and safely reintroducing invasive cardiovascular procedures after the peak of COVID-19 has passed. The...
A study presented at EAPC Essentials 4 You—a virtual scientific platform of the European Society of Cardiology (ESC)—found that the top three myocardial infarction symptoms in both women and men are chest pain, sweating, and shortness of breath. These...
LifeSignals has received CE mark approval for the LifeSignals ECG Remote Monitoring Patch, a disposable wireless remote monitoring system, intended for use by healthcare professionals for continuous collection of Electrocardiography (ECG) and heart rate monitoring in ambulatory, hospital, healthcare...
A necklace that detects abnormal heart rhythm will be showcased for the first time on EHRA Essentials 4 You, a scientific platform of the European Society of Cardiology (ESC). According to the study's author, Elmeri Santala from the University of...
PCR has issued a statement announcing that it is officially cancelling the 2020 physical EuroPCR congress, which was due to take place in two weeks’ time (19–22 May, Paris, France). According to the statement, the “sanitary and legal environment”—specifically,...
Recent studies have suggested that during the pandemic, there has been a drop in ST-segment elevation myocardial infarction (STEMI) cases. This has led to fears that patients are not seeking medical attention when they experience symptoms of a STEMI...
A new study has found no significant differences in hospital mortality between multivessel percutaneous coronary intervention (PCI) and culprit-vessel only PCI for the management of cardiogenic shock patients who had received early mechanical circulatory support. These findings suggest that,...
Before the 1940s, the prognosis for babies born with complex congenital heart disease was dismal. Less than 10% of these children survived to adulthood. However, since then, major breakthroughs in the detection and treatment of congenital conditions have greatly...
Prism Schneider (Cumming School of Medicine, University of Calgary, Calgary, Canada) and others write in a commentary in the Canadian Medical Association Journal—because of an increase in domestic violence during the pandemic—healthcare providers should be aware of the signs...
Abiomed (maker of the Impella heart pump) has acquired Breethe, developer of a novel extracorporeal membrane oxygenation (ECMO) system. A press release reports that the acquisition will complement and expand Abiomed’s product portfolio to more comprehensively serve the needs of...
New guidance from the American Academy of Neurology (AAN) recommends the closure of a patent foramen ovale (PFO) for some people who have had a stroke. The updated practice advisory has been published online in Neurology. Previous guidance concluded...
On 18 March, the Centers for Medicare & Medicaid Services (CMS) recommended “limiting non-essential care and expanding surge capacity into ambulatory surgical centres and other areas” to conserve resources and staff for managing COVID-19 patients. However, in a statement...
Robocath, which designs, develops and commercialises cardiovascular robotic systems for the treatment of vascular diseases, has secured €40 million ($43M) in a series C round of financing. A press release reports that this was led by MicroPort Scientific Corporation,...
iRhythm Technologies has announced a virtual platform to support patients and clinicians in the wake of COVID-19 by offering home enrolment for the company’s Zio XT and Zio AT heart monitoring devices. Since patients with heart conditions are a particularly...
Boston Scientific, according to a press release announcing the company’s Q1 2020 financial results, has received the CE mark for its Acurate neo2 aortic valve system. The press release reports that the transcatheter aortic valve implantation (TAVI) system builds...
The Society for Cardiovascular Angiography and Interventions (SCAI) and Canadian Association of Interventional Cardiology (CAIC) have formed the North American COVID-19 ST-Segment Elevation Myocardial Infarction Registry (NACMI). The study will be chaired by Tim Henry (SCAI) and Payam Dehghani...
A press release reports that the British Heart Foundation (BHF) and the National Institute of Health research (NIHR) have joined forces to launch a nationwide research initiative to better understand why people with heart and circulatory diseases are at...
VisCardia has been granted Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its implantable VisONE system, which is designed for the treatment of moderate-to-severe heart failure with reduced ejection fraction and preserved ventricular synchrony. A...
LivaNova has announced that several of its cardiopulmonary products are can now be used in the USA for extracorporeal membrane oxygenation (ECMO) therapy for more than six hours, per guidance issued by the US Food and Drug Administration (FDA)...
In the Journal of American College of Cardiology, Ehtisham Mahmud (University of California, San Diego, Sulpizio Cardiovascular Center, La Jolla, USA) and others outline, in a consensus statement, recommendations for managing acute myocardial infarction during the COVID-19 pandemic. The...
A press release reports that several of the world’s ventilator manufacturers have formed a Ventilator Training Alliance (VTA) and partnered with Allego to create a mobile app that frontline medical providers can use to access a centralised repository of...
New data suggest that a medical device that uses vitamin B2 and ultraviolet light for treating human blood products is effective against the virus that causes COVID-19. The study results, generated by Terumo BCT in collaboration with top researchers...
Pi-Cardia has closed a US$27 million round of financing, led by Sofinnova Partners. A press release reports that Pi-Cardia’s Leaflex catheter performs mechanical scoring of valve calcification, restoring leaflets’ mobility and improving valve haemodynamics. The Leaflex catheter is designed...
Proximo Medical has announced a partnership with Elucid Bioimaging, a developer of diagnostic image analysis software used to assist in the detection and treatment of myocardial infarction and stroke. A press release states that Elucid Bioimaging’s signature technology, vascuCAP,...
Studies have shown that robotic percutaneous coronary intervention (PCI) with the CorPath GRX System (Corindus, now part of Siemens Healthineers)—compared with manual PCI—reduces radiation exposure to the cath lab staff and may also improve precision. Furthermore, during the current...
In response to a recent American College of Cardiology (ACC) review that advocated that troponin should only be measured when a diagnosis of acute myocardial infarction is being considered, Andrew R Chapman (BHF Centre for Cardiovascular Science, Royal Infirmary...
In the first of a series of webinars focusing on COVID-19, Society for Cardiovascular Angiography and Interventions (SCAI) president Ehtisham Mahmud (Cardiovascular Medicine, University of California, La Jolla, USA) and colleagues reviewed transcatheter aortic valve implantation (TAVI) procedures during...
The COVID-19 pandemic is hitting the world hard. Egypt, the most populous country in the Middle East and North Africa (MENA) region, is no exception. With more than 2,500 confirmed cases and a preliminary case fatality rate of 7%...
Impulse Dynamics has announced the publication of the FIX-HF-5C2 study in Circulation: Heart Failure. A press release reports that the study affirms the safety and efficacy of the company’s 2-lead version of the Optimizer system, which was approved by...
Enrique Ostrzega (University of Southern California, Los Angeles, USA) and colleagues report in in JACC: Case Reports that using applied abdominal pressure relived the symptoms of an apparent sudden-onset ST-segment elevation myocardial infarction (STEMI) in a patient with severe...
The US Food and Drug Administration (FDA) issued an emergency use authorisation for a blood purification system (Spectra Optia Apheresis System, Terumo BCT) combined with Adsorption Cartridge (Marker Therapeutics) to treat patients 18 years of age or older with confirmed...
Santiago Garcia (Minneapolis Heart Institute Foundation, Abbott Northwestern Hospital, Minneapolis, USA) and colleagues report in the Journal of the American College of Cardiology that there was a 38% drop in cath lab ST-segment elevation myocardial infarction (STEMI) activations in...
The American Heart Association (AHA) has compiled interim CPR guidelines to help rescuers treat cardiac arrest patients with suspected or confirmed COVID-19. The guidelines are in collaboration with the American Academy of Pediatrics, American Society of Anesthesiologists, American Association...
In a brief report in Annals of Internal Medicine, Seongman Bae (Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea) and colleagues report that neither surgical nor cotton masks appear to be an effective approach for preventing the dissemination of SARS-CoV-2 from...
Physicians recognised the importance of remote management for heart failure patients long before the COVID-19 pandemic. However, the current situation has heightened the urgency of the transition for this vulnerable population. In this commentary, Michael Kiernan reviews how remote...
In separate statements, the European Society of Cardiology (ESC) and American College of Cardiology (ACC) are calling for patients to still seek immediate medical attention if they experience symptoms of a myocardial infarction despite any fears they may have...
Abbott has received the CE mark for its TriClip transcatheter tricuspid valve repair system. It can, therefore, be used as a non-surgical treatment for people with a leaky tricuspid valve in Europe and in other regions where the CE...
Presidents of leading cardiac organisations, including the American Heart Association (AHA), the American College of Cardiology (ACC) and the Heart Rhythm Society (HRS), have published a statement that cautions against the use of hydroxychloroquine and azithromycin for the treatment...
Royal Philips has announced that the US government and Philips agreed to team up to increase the production of hospital ventilators in its manufacturing sites in the USA. Philips plans to double the production by May 2020  and achieve...
Mardil Medical has announced the successful completion of treatment for the third patient in the clinical trial of its improved VenTouch device for type IIIb functional mitral valve regurgitation. A press release reports that the device is a combination...
Shockwave Medical has completed enrolment in its US Food and Drug Administration (FDA) Investigational Device Exemption (IDE) study—DISRUPT CAD III—for the use of intravascular lithotripsy (IVL) for the management of heavily calcified coronary arteries. A press release reports that...
Ahmed Bendary describes the findings of a meta-analysis published last month that determined outcomes for cancer patients following transcatheter aortic valve implantation (TAVI). He tells Cardiovascular News what can be done to ensure that these patients survive valvular problems.  Patients...
A soft robotic heart that is designed to replace the need for a heart transplant is one of four research projects that have made the shortlist for the Big Beat Challenge initiative—organised by the British Heart Foundation—that awards £30m...
At the 2019 European Association of Cardio-Thoracic Surgeons (EACTS) annual meeting (3–5 October, Lisbon, Portual), Max Y Emmert (Institute for Regenerative Medicine, University of Zurich, Switzerland/the Department for Cardiothoracic and Vascular Surgery, German Heart Center Berlin and Charite Berlin,...
Cardiovascular specialists from across the globe shared current knowledge and key experience of managing COVID-19 patients as part of a webinar organised by the Imperial College Network of Excellence in Vascular Science at Imperial College London. The four-part COVID-19 Cardiovascular...
The American Heart Association (AHA), in conjunction with the American Association for Respiratory Care (AARC) and American Society of Anesthesiologists (ASA) is offering guidance in oxygenation and ventilation management for healthcare providers as hospital volumes surge from COVID-19. AHA released...
The reduced levels of angiotensin converting enzyme (ACE) 2 associated with cardiovascular disease and increasing age lead to a higher susceptibility to greater disease severity in COVID-19. A viewpoint published online in JAMA Cardiology hypothesises that severe acute respiratory...
Edwards Lifesciences has temporarily paused new enrolments in its active pivotal clinical trials of its transcatheter mitral and tricuspid therapies in response to ongoing COVID-19 pandemic. A press release reports that the company is coordinating closely with the trials’...
The European Commission (EC) has adopted a proposal to postpone by one year the date of application of the new Medical Devices Regulation (MDR), which was due to come into force on 26 May this year. The postponement, a press...
Athena Poppas (Providence, USA) is the new president of the American College of Cardiology (ACC). Her term officially began at the close of the ACC/World Congress of Cardiology’s virtual scientific sessions (ACC.20/WCC Virtual). Poppas has been a long-standing leader of...
Simon Ray, president of the British Cardiovascular Society (BCS), has told the COVID-19 Cardiovascular Conference that a lack of consistency in national guidance around personal protective equipment (PPE) during COVID-19 had led to a “vacuum” which has had to...
In a new statement published on 2 April 2020, all 45 societies represented by the US Council of Medical Specialty Societies (CMSS)—over 800,000 physicians—emphatically declare their belief that all frontline healthcare professionals must have access to personal protective equipment...
A raised troponin level in myocardial injury “greatly alters the prognosis adversely” in COVID-19 patients, Graham Cole (Imperial College Healthcare NHS Trust, London, UK) told a virtual cardiovascular conference, hosted today by Imperial College London. Cole explained: “Troponin rises occur...
The COVID-19 Cardiovascular Conference, hosted as a live webinar by The Imperial College Network of Excellence in Vascular Science at Imperial College (London, UK), has heard about experiences from both Italy and the USA, as well as details of...
Cardiologists from across Europe have shared their experience of having treated COVID-19 patients, in a series of videos produced by the European Society of Cardiology (ESC), part of a suite of resources provided by the society to aid physicians...
The American College of Surgeons (ACS) today leapt to the defense of healthcare workers who are heading to work in the face of increasing concerns over personal protective equipment (PPE) shortages as the COVID-19 pandemic cuts trails across the...
Daniel M Philbin Jr has been named chair of the American College of Cardiology (ACC) board of governors and secretary of the board of trustees, the main governing body of the ACC, for 2020–2021. His term began at the...
The Imperial College Network of Excellence in Vascular Science at Imperial College London (UK) is to run a COVID-19 Cardiovascular Conference as a live webinar on Thursday 2 April for all healthcare professionals battling COVID-19. The webinar aims to share...
According to Geu-Ru Hong (Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, Korea), edoxaban may be an alternative to warfarin for preventing thromboembolism in the first three months after surgical bioprosthetic valve replacement or repair....
Results from the phase 2 MAVERICK-HCM clinical trial, presented at the American College of Cardiology/World Congress of Cardiology’s virtual scientific sessions (ACC.20/WCC Virtual) suggest that the use of mavacamten (MyoKardia) for the treatment of non-obstructive hypertrophic cardiomyopathy (nHCM) may be...
The longest follow-up to date of patients with left main coronary artery disease (LMCAD) has found no significant differences in rates of death, myocardial infarction or stroke between patients who underwent percutaneous coronary intervention (PCI) and those who had...
Today at the American College of Cardiology/World Congress of Cardiology’s virtual scientific sessions (ACC.20/WCC Virtual)—originally scheduled to take place on 28–30 March in Chicago, USA—D Scott Lim (University of Virginia, Charlottesville, USA) reported that mitral regurgitation ≤1+ was achieved more frequently with MitraClipNTR or with MitraClipXTR (both Abbott) than...
Using the radial artery instead of the saphenous vein for patients undergoing coronary artery bypass graft (CABG) surgery leads to lower mortality and better cardiac outcomes, according to research presented at the American College of Cardiology’s Virtual Scientific Session...
Medtronic today announced positive results of the Onyx ONE Clear Study that evaluated the Resolute Onyx drug-eluting stent (DES) in high bleeding risk (HBR) patients with one-month dual antiplatelet therapy (DAPT) in the USA and Japan. Results from the...
“More bleeding with background clopidogrel, even if not severe by adjudication, may be associated with broad consequences, including discontinuation of therapies. In the absence of clear benefit, clopidogrel exposure along with aspirin and rivaroxaban should be minimised or avoided...
Transcatheter aortic valve implantation (TAVI) procedures had a high rate of success and low risk of death or disabling stroke at 30 days in patients with a bicuspid aortic valve, according to research presented by Basel Ramlawi (Valley Health,...
Three months after undergoing renal denervation, patients with untreated high blood pressure had statistically significant reductions in average blood pressure over 24 hours compared with patients who underwent a sham procedure according to results from the SPYRAL-HTN OFF MED pivotal...
Data from the National Cardiovascular Data Registry (NCDR) Left Atrial Appendage Occlusion (LAAO) Registry, which enrolled more than 38,000 patients implanted percutaneously with the Watchman device (Boston Scientific), reveal a high implant success rate and a low rate of...
In the POPULAR TAVI trial, patients with atrial fibrillation who took oral anticoagulants alone after undergoing transcatheter aortic valve replacement (TAVI)—had a lower rate of bleeding complications without an increased risk of clotting-related complications, compared to patients who took...
During the first Featured Clinical Research session of the virtual American College of Cardiology (ACC) event (28–30 March, Central Time), Michelle Samuel (Montreal Health Institute, Montreal, Canada) reported that the addition of low-dose colchicine (0.5mg daily) to standard-of-care therapy...
In stable atherosclerosis, a combination of aspirin plus rivaroxaban provided a similar relative degree of benefit on coronary, cerebrovascular, and peripheral endpoints in patients with and without diabetes, a prespecified analysis of the COMPASS trial has shown. It also...
Treatment with aspirin plus rivaroxaban following lower extremity revascularisation in patients with peripheral arterial disease (PAD) leads to a 15% reduction in the risk of major adverse limb and cardiovascular events when compared with aspirin alone. The VOYAGER PAD study...
Today, during the Virtual American College of Cardiology (ACC) event (28–30 March, Central Time), Naveen L Pereira (Mayo Clinic, Rochester, USA) told the online audience that using genetic testing to guide antiplatelet therapy after percutaneous coronary intervention (PCI) does...
During a Q&A section of a European Commission (EC) college meeting on 25 March, EC spokesperson Stefan de Keersmaecker stated that the commission were looking to delay the “entry into force” of the new European medical device regulations (MDR) because of...
A viewpoint in the Journal of the American Medical Association (JAMA) has offered potential solutions to modifying ongoing randomised clinical trials during the COVID-19 pandemic. It aims to “minimise disruption and preserve integrity”, while still ensuring participant health and...
Cardiac injury is common among hospitalised patients with COVID-19, and is associated with a higher risk of in-hospital mortality, a study from Wuhan, China, has shown. Although the exact mechanism of cardiac injury has not been defined, the researchers...
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) has written to the medical device industry to outline its response to the COVID-19 public health emergency in its day-to-day operations with industry. The letter from...
The American Heart Association (AHA) has committed US$2.5 million to research efforts to better understand the novel coronavirus, COVID-19, and its interaction with the body’s cardiovascular and cerebrovascular systems. Specifically, the Association will be offering fast-tracked research grants for short-term...
The British Cardiovascular Intervention Society (BCIS) and the British Cardiovascular Society (BCS) have endorsed guidance published by NHS England and NHS Improvement on the provision of cardiology services during the COVID-19 pandemic. A joint statement from Nick Curzen, president of...
The Society for Cardiology and Angiography Interventions (SCAI) has set up a dedicated section on its website to keep interventional cardiologists up to date on practice and safety measures required for interventional practice in COVID-19. The society has also...
CroíValve has announced the successful first human use of its Duo Tricuspid Coaptation Valve technology for tricuspid repair. The company says the procedure was performed by an experienced heart team in St James’ University Hospital (Dublin, Ireland). A statement from...
A new Heart & Stroke guideline published today in the Canadian Medical Association Journal does not recommend taking ASA (Acetylsalicylic acid) as a preventive measure for those who do not have a history of stroke or heart or vascular disease,...
A case series of US experience with COVID-19 has upheld suggestions of a link with cardiomyopathy, which developed in 33% of intensive care patients. In a research letter published in the Journal of the American Medical Association, Matt Arentz (Department...
The US Food and Drug Administration (FDA) has issued an immediately-in-effect guidance that allows manufacturers of certain FDA-cleared non-invasive, vital-sign-measuring devices to expand their use so that health care providers can use them to monitor patients remotely. The devices...
The first report on the impact of COVID-19 on heart transplant recipients has been published in The Journal of Heart and Lung Transplantation, outlining the management strategy by a team in Wuhan for two patients who contracted the virus...
Frailty is an independent predictor of morbidity, death, and increased costs after mitral valve replacement (MVR), a retrospective cohort study has determined. Writing in The Annals of Thoracic Surgery, Amit Iyengar (Division of Cardiac Surgery, and Perelman School of Medicine,...
The Society for Cardiovascular Angiography and Interventions (SCAI) has written an open letter to members detailing options for managing patients in the cath lab who present with COVID-19. SCAI president Ehtisham Mahmud, (University of California, San Diego) points out: “A...
Data from a pilot imaging study of commissural alignment in trancatheter aortic valve implantation (TAVI) has found that more than 30–50% of cases had overlap with one or both coronary arteries. Gilbert HL Tang (Mount Sinai Medical Center, New...
European CE mark has been awarded to the TriGUARD 3 cerebral embolic protection (CEP) device from Keystone Heart, a Venus Medtech Company. According to the company, TriGUARD 3 is the only CE marked product designed to cover and protect all...
Portola Pharmaceuticals announced new data that they say reinforces the value of Andexxa (coagulation factor Xa , inactivated-zhzo]. The company statement outlines that the data demonstrate Andexxa was associated with a lower rate of in-hospital and 30-day mortality in...
Early improvement in health status for patients in the COAPT trial who had transcatheter mitral valve repair (TMVr) with the MitraClip (Abbott) was strongly associated with reduced long-term risk of death or heart failure hospitalisation. COAPT investigators Suzanne V Arnold...
Patients who have a percutaneous coronary intervention (PCI) for chronic total occlusion following a coronary artery bypass graft (CABG) have worse outcomes than those without prior surgery, a meta-analysis published in JACC: Cardiovascular Interventions has found. The research was...
The novel left atrial appendage (LAA) closure device Appligator (Append Medical) was a finalist in the 2019 ICI Innovation Award Competition (Innovation in Cardiovascular Interventions 2019; 8–10 December, Tel Aviv, Israel).  Leonid Sternik, who came up with the concept...
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...
The American College of Cardiology Scientific Session Together with World Congress of Cardiology (ACC.20/WCC) is to run as a virtual meeting, following its cancellation due to the coronavirus outbreak. It was scheduled to take place 28–30 March 2020 in...
Vascular remodelling may occur in response to sustained, regular exercise, suggests a study of aortic dilatation among long-term endurance athletes. Timothy W Churchill (Massachusetts General Hospital, Boston, USA) et al found a “marked increase in the prevalence of aortic...
Abbott has received CE mark in Europe for the new FlexNav delivery system for the company's Portico transcatheter aortic valve implantation (TAVI) system. A statement from the company says that with the approval, physicians implanting Portico can benefit from...
The New England Journal of Medicine (NEJM) has launched a review into the data from the EXCEL trial, two members of the BBC Newsnight team have reported in the BMJ. Deborah Cohen and Ed Brown from the Newsnight current...
A short film (“Today is a Good Day”), which showcases the work of Aortic Dissection Awareness UK & Ireland, has won the Rare Disease Film Festival’s Peoples’ Choice award. According to Rare Disease UK, the organisers of the event, the film festival...
NOTE: This video is ONLY available to watch in selected countries and geographies Rajesh Kharbanda (Oxford, UK) and Oliver Husser (Dortmund, Germany) talk to BLearning Cardio about some of the major advancements in TAVI procedures over the past few years as well...
NOBLE finds PCI inferior to CABG at five years in left main disease EXCEL: repeat revascularisation after both CABG and PCI leads to increased mortality Profile: Nicolas van Mieghem BIBA Briefings: Sapien 3 becomes first TAVI valve to...
NOBLE finds PCI inferior to CABG at five years in left main disease EXCEL: repeat revascularisation after both CABG and PCI leads to increased mortality Profile: Nicolas van Mieghem BIBA Briefings: Sapien 3 becomes first TAVI valve to...
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...
Findings from an interim analysis of PROTECT III have added to the evidence for improved outcomes with Impella heart pumps in protected percutaneous coronary intervention (PCI). PROTECT III is part of the PROTECT series of trials initiated by Abiomed...
CryoLife has received CE mark for the On-X Ascending Aortic Prosthesis (AAP), allowing resumed distribution in the European Union. The On-X AAP is indicated for the treatment of diseased, damaged or malfunctioning native or prosthetic heart valves in the aortic...
The US Food and Drug Administration (FDA) has cleared a new version of the LivaNova Heater-Cooler System 3T, which is used during cardiothoracic surgery to warm or cool a patient to improve medical care and patient outcomes. The changes—designed,...
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)...
A research project at the University of Leeds aiming to identify new drug treatments for heart failure patients has been awarded a grant of almost £150,000 by British charity Heart Research UK.  The project, which will be led by Scott...
Transcatheter aortic valve implantation (TAVI) is safe in the short term in low-risk patients with symptomatic, severe bicuspid aortic stenosis (AS). Researchers also noted that subclinical leaflet thrombosis was present in a minority of patients at 30 days, but...
Patients who develop stage 3 acute kidney injury (AKI) following transcatheter aortic valve implantation (TAVI) have seven times higher adjusted one-year mortality than patients who do not develop AKI. Researchers also found that more than 10% of patients develop...
Biotronik has announced three-year data from the BIOFLOW-V trial, which were presented at the Cardiac Resynchronisation Therapy meeting (CRT 2020; 23–25 February, Washington DC, USA). A statement from the company says the three-year findings demonstrate consistently lower clinical event...
Append Medical, developer of the Appligator, a novel left atrial appendage (LAA) closure device to minimise stroke risk in atrial fibrillation (AF) patients, and Sheba Medical Center (Ramat Gan, Israel), have announced the clinical proof-of-concept data evaluating the safety...
Edwards Lifesciences has announced a new goal for its philanthropic initiative, Every Heartbeat Matters (EHM), which aims to improve the lives of 2.5 million additional underserved structural heart and critical care patients by the end of 2025. The company...
A comparison of newer generation self-expanding valves (SEV) and balloon-expandable valves (BEV) in high-risk patients with aortic stenosis undergoing transfemoral transcatheter aortic valve implantation (TAVI) has found that they are equivalent for the primary valve-related efficacy endpoint. The authors...
Ablative Solutions has revealed that positive six-month results from the Peregrine post-market study demonstrating the safety and efficacy of the company’s CE-marked Peregrine System infusion catheter were published in the Journal of the American College of Cardiology: Cardiovascular Interventions. The...
Cardiovalve has received US Food and Drug Administration (FDA) approval for an early feasibility study (EFS) of its transcatheter tricuspid valve replacement system for a tricuspid regurgitation (TR) indication. The Cardiovalve System has also been granted Breakthrough Device Designation...
Last month, Abbott announced US Food and Drug Administration (FDA) approval of a new trial—REPAIR MR—to evaluate the safety and efficacy of percutaneous edge-to-edge repair (MitraClip) for the management of patients with primary mitral regurgitation at moderate surgical risk....
The news programme BBC Newsnight has made further claims that the EXCEL investigators “held back” data from the published results of the left main trial. In a programme that aired on 18 February, reporter Deborah Cohen claims that Gregg...
VitalConnect has announced the introduction of arrhythmia detection to its remote monitoring portfolio. In partnership with CorVitals, VitalConnect now offers physicians the ability to monitor, diagnose and treat patients suffering from various heart conditions and diseases. With arrhythmia detection, clinicians...
Gregg W Stone (Icahn School of Medicine, Mount Sinai, New York, USA) addressed the EXCEL controversy today at the Joint Interventional Meeting (JIM 2020; 13–15 February, Milan, Italy), stipulating that although percutaneous coronary intervention (PCI) has early advantages and...
Nicolas van Mieghem

Nicolas van Mieghem

Nicolas van Mieghem (professor of interventional cardiology, department of cardiology, Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands) shares his thoughts on a wide range of topics with Cardiovascular News, including mechanical circulatory support and artificial intelligence, the durability...
The US Food and Drug Administration (FDA) has authorised marketing of software to assist in the acquisition of cardiac ultrasound, or echocardiography, images. The software, called Caption Guidance (Caption Health), is an accessory to compatible diagnostic ultrasound systems and...
Orsiro Mission DES

Orsiro Mission gets CE mark

Biotronik has received CE mark certification for the Orsiro Mission drug-eluting stent (DES) system. According to a company statement, the next generation of the ultrathin strut Orsiro DES provides higher deliverability than other contemporary stents. Orsiro Mission is now...
Philips has announced a new randomised controlled trial to assess percutaneous coronary intervention (PCI) guided by its coregistration platform, which combines data of an instant wave-Free Ratio (iFR) measurement and an angiogram, compared with standard of care treatment guided...
Scott Lim (Charlottesville, USA) talks to BLearning Cardio at PCR London Valves 2019 (17–19 November, 2019; London, UK) about the challenges associated with transcatheter tricuspid valve intervention. Lim explains that the patient population with tricuspid regurgitation is very heterogeneous, and so there is a need for a...
 Philippe Pibarot (Québec, Canada) talks to BLearning Cardio at PCR London Valves 2019 (17–19 November, 2019; London, UK) about the main data findings in the PARTNER 2 trial which evaluated more than 2,000 intermediate-risk patients with severe aortic stenosis who either underwent a TAVI procedure...
BioVentrix has received renewal of the highest priority reimbursement in Germany for its Revivent TC transcatheter ventricular enhancement system. A company statement announced that it has been given NUB Status 1 designation from InEk, the German Institute for Hospital...
Extended 10-year follow-up has demonstrated that in patients with a high SYNTAX score undergoing left main coronary artery (LMCA) revascularisation there is a clear prognostic benefit for coronary artery bypass graft (CABG) over percutaneous coronary intervention (PCI). PCI was...
The debate over the results of EXCEL shows no sign of abating, and there seems to be a division between cardiac surgeons and interventional cardiologists about which side of the argument they fall on, with surgeons generally supporting EACTS,...
Medtronic has announced that it will begin enrolment in a pilot study evaluating the safety and efficacy of the Symplicity Spyral renal denervation (RDN) system using a targeted procedural approach with a reduced number of radio frequency (RF) ablations....
The US Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Abbott for its in-development fully implantable left ventricular assist system (FILVAS). The FDA Breakthrough Device Designation programme will allow, according to Robert L Kormos (medical director...
Rajiv Patni has been appointed as executive vice president and chief medical officer at Portola Pharmaceuticals, effective immediately. The company announced the appointment in a press release, stating that Patni will report to Scott Garland, president and chief executive...
 Frank Arko (Charlotte, USA) talks to VEITHtv at the VEITHsymposium 2019 (19–23 November, New York, USA), about the benefits of using Shockwave Intravascular Lithotripsy (IVL) when performing EVAR and TEVAR through calcified iliac arteries. Arko, who shares some of the downsides of traditional procedures...
Guy’s and St Thomas’ and Royal Brompton & Harefield NHS Foundation Trusts are to merge. A joint statement from the two trusts has announced their plans for closer working, indicating that the arrangements include the creation of a hub...
The Tendyne transcatheter mitral valve implantation (TMVI) system (Abbott) has received the CE mark, making Abbott the first company to have such a device on a market anywhere in the world. A press release reports that this “life-changing” therapy...
Highly-tweeted articles are 11 times more likely to be cited than less tweeted articles, Ourania Preventza (Division of Cardiothoracic Surgery, Baylor College of Medicine, Houston, USA) told delegates at the 56th Annual Meeting of The Society of Thoracic Surgeons...
David Hayes, former physician administrator at Mayo Clinic, Rochester, USA, has been appointed chief medical officer of Biotronik, a company press release reports. "Our focus has always been on the patient. To help patients live their best lives, we remain...
Open heart surgery remains the best option for young and middle-aged adults with aortic valve disease, for now; However, the use of transcatheter aortic valve implantation (TAVI) is continuing to expand to a wider group of eligible patients, according...
Patients discharged three days after open heart surgery are not at increased risk of complications, an analysis of discharge patterns has shown. S Chris Malaisrie (Northwestern Medicine, Chicago, USA) unveiled the findings at the 56th Annual Meeting of the Society...
NOTE: This video is ONLY available to watch in selected countries and geographies Azeem Latib (New York, USA) talks to BLearning Cardio about some of the major advancements in TAVI over the past few years including the...
Terumo has announced the launch of a new randomised clinical trial: the DIStal vs. COnventional RADIAL access trial (DISCO RADIAL). The trial compares the novel distal radial access with conventional radial access approach, in terms of radial occlusion rates...
The largest study to date of the role of frailty indices after transcatheter aortic valve implantation (TAVI) has demonstrated that the markers of low albumin, anaemia, and slow walking speed are significant independent predictors of mortality and morbidity in...
The TASTE and TOTAL studies suggested that routine thombus aspiration in patients undergoing percutaneous coronary intervention (PCI) did not provide mortality benefit and may increase the risk of stroke. However, a new study (CHEETAH) is evaluating whether a next-generation...
FEops has announced that the first patient has been enrolled in the physician-initiated PREDICT-LAA trial. The trial is led by Righshospitalet (Copenhagen, Denmark) and aims to assess whether the use of FEops HEARTguide computer simulations based on cardiac CTimaging can...
George Adams (Raleigh, USA) talks to VEITHtv at the VEITHsymposium 2019 (19–23 November, New York, USA) about the benefits of using easy-to-use Shockwave IVL (Intravascular Lithotripsy) in calcified below-the-knee vessels, which he says, results in “great outcomes”. Adams explains that calcific plaque, particularly medial...
Emboline has completed enrolment in its SAFEPASS 2 clinical study of the Emboliner embolic protection catheter. A press release from the company, which develops total embolic protection technology for transcatheter aortic valve implantation (TAVI), also indicates that early results...
BioCardia has received US Food and Drug Administration (FDA) 510(k) clearance for its Morph DNA deflectable guide catheter, used to guide the Helix biotherapeutic delivery system during CardiAMP cell therapy delivery in the heart. A company statement explains that the...
Spartan Bioscience, a maker of precision medicine diagnostic solutions, has established a new scientific advisory board (SAB) in Europe for cardiac stent patients that consists of international clinical and academic interventional cardiologists. The company says the role of the...
A secondary analysis of repeat revascularisation in the EXCEL trial has found that it was associated with increased mortality after both percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) in patients with left main coronary artery disease...
The Society of Thoracic Surgeons (STS) has issued a statement on the controversy surrounding EXCEL, commenting that “that the final interpretation regarding the outcomes of the EXCEL study should wait until an independent analysis of all aspects of the...
The American College of Cardiology (ACC) has announced several promotions and structural changes within its senior staff. The College said that the staff changes will “further consolidate and strengthen the organisation’s efforts in achieving its strategic goals, mission and...
Abbott has announced that the US Food and Drug Administration (FDA) has approved a first-of-its-kind clinical trial that will compare the effectiveness of Abbott's MitraClip device to open heart mitral valve surgical repair in people with primary mitral regurgitation...
A retrospective registry comparing four self-expanding transcatheter heart valves has demonstrated good haemodynamic performance in small aortic annuli, with low post-procedure gradients, large orifice areas, and a low incidence of severe patient–prosthetic mismatch (PPM). Writing in JACC: Cardiovascular Interventions, investigators...
Abbott has announced US Food and Drug Administration (FDA) approval of a new alternative surgical technique for Abbott's HeartMate 3 heart pump that the company says will allow more advanced heart failure patients to avoid open heart surgery. The...
B Braun has announced the appointment of Jean-Claude Dubacher as chairman and CEO. Dubacher joined B Braun on 1 August 2019 as president, B Braun Medical. A press release reports that Dubacher’s experience in the healthcare industry spans more...
Proximo Medical is to partner with CeloNova Biosciences, supplier of the COBRA PzF nanocoated coronary stent (NCS), in select US markets. Carl St Bernard, chief executive officer of CeloNova Biosciences, states in the press release: “By partnering with Proximo Medical,...
The European Association of Cardio-Thoracic Surgeons (EACTS) has issued a statement reaching out to EXCEL investigators to “offer assistance” in resolving concerns raised about data from the trial. In a letter sent to the principal investigators, EACTS recommends that...
The European Association of Cardio-Thoracic Surgeons (EACTS) has published a detailed account of the process that led to its “unprecedented” decision to reverse its endorsement of a section of its joint 2018 myocardial revascularisation guidelines, developed with the European...
Five-year data from the NOBLE trial have confirmed its earlier findings that in patients with unprotected left main coronary disease the risk of major adverse cardiac or cerebrovascular events (MACCE) is higher with percutaneous coronary intervention (PCI) than with...
The Society for Thoracic Surgeons (STS) and the European Association of Cardio-Thoracic Surgeons (EACTS) have announced that they will participate in a strategic collaboration. A joint press release issued by Robert SD Higgins, president of the STS, and Domenico Pagano,...
The US Food and Drug Administration has granted Breakthrough Device designation to the digital health and artificial intelligence (AI) company Eko for an echocardiogram (ECG)-based algorithm to help identify induced Left Ventricular Ejection Fraction (LVEF). FDA Breakthrough Device designation helps...
Daiichi Sankyo Europe has announced outcomes from an observational study in mainly caucasian atrial fibrillation (AF) patients being treated with the anti-coagulation drug edoxaban (Lixiana). The results of the Danish observational cohort study, published in the European Heart Journal...
A pivotal, multicentre clinical trial is exploring the use of an Impella heart pump (Abiomed) to unload the left ventricle for 30 minutes prior to coronary revascularisation. The aim of the trial is to test the hypothesis that unloading...
Edwards Lifesciences has received the CE mark for its Sapien 3 transcatheter aortic valve implantation (TAVI) device to be used to manage aortic stenosis in low-risk patients. Both Edwards and Medtronic (with its CoreValve Evolut range) have FDA approval...
Gregg Stone (The Zena and Michael A Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, USA), on behalf of the EXCEL leadership, has sent Cardiovascular News (and other media outlets) a 3,500-word document refuting the...
George Dangas (Mount Sinai Hospital, New York, USA) told delegates in a late-breaking trial session at the American Heart Association Scientific Sessions (AHA 2019; 16–18 November, Philadelphia, USA) that “in patients without an established indication for oral anticoagulation after...
  The European Association of Cardio-Thoracic Surgery (EACTS) has withdrawn its support of the left main recommendations of the society’s joint guidelines with the European Society of Cardiology (ESC) on myocardial revascularisation following an investigation into the EXCEL trial by the...
InnovHeart—a developer of novel transcatheter mitral valve replacement (TMVR) systems—has appointed medical device entrepreneur J Brent Ratz as nonexecutive independent member of its Board of Directors. A press release reports that Ratz has more than 19 years of experience...
Data from the CAP and CAP2 registries—which contain the longest and largest follow-up of patients—add to previous evidence that left atrial appendage closure (LAAC) with Watchman (Boston Scientific) is a safe and effective alternative to long-term anticoagulation in patients...
Bioventrix has announced online publication of positive one-year results from its CE mark study of the Revivent TC System in the European Journal of Heart Failure. The paper will be published in print in the January issue. A press statement...
The TASTE and TOTAL studies suggested that routine thombus aspiration in patients undergoing percutaneous coronary intervention (PCI) did not provide mortality benefit and may increase the risk of stroke. However, a new study (CHEETAH) is evaluating whether a next-generation...
  A significant milestone has been reached for a landmark study into the use of short duration dual anti-platelet therapy (DAPT) in high-bleeding-risk (HBR) patients following stenting procedures, with patient recruitment just completed. A total cohort of approximately 4,500 patients have...
Michael Reardon (Houston, USA) talks to BLearning Cardio about the ADAPT tissue technology (Admedus), and the increasing importance of durability as TAVI moves to younger and lower risk patients. Reardon notes that “we would like to have technology that does even better...
The largest trial to date to compare revascularisation with a conservative strategy in patients with stable ischaemic heart disease has found no additional benefit a median of three years after the procedure. Data from the ISCHEMIA trial were presented at...
Preprocedural administration of an oral colchicine load does not reduce the risk of myocardial injury or 30-day major adverse cardiovascular events (MACE) in patients undergoing percutaneous coronary intervention (PCI), according to findings from the COLCHICINE-PCI (Effects of acute colchicine...
Meril has announced positive data on its Myval Transcatheter Heart Valve System at PCR London Valves 2019 (17–19 November 2019). A follow-up of 100 patients with intermediate- to high-risk for surgical aortic valve replacement (SAVR) in the MyVal-1 study...
Corindus has announced the completion of the first multicity, transcontinental percutaneous coronary intervention (PCI) simulations in the USA over three network connection types: 5G wireless, dedicated fibre, and commercial public internet networks. A press release reports that Ryan Madder...
The Revivent transcatheter ventricular enhancement system (Bioventrix) has been granted Breakthrough Device Designation by the US Food and Drug Administration (FDA). The Revivent investigational transcatheter device uses micro-anchors to cinch together the scarred area of the left ventricle to...
An analysis of structural valve deterioration in the PARTNER 2A trial has found that the third generation Sapien 3 transcatheter heart valve (Edwards Lifesciences) has similar durability to surgical valves, with the second generation Sapien XT (also Edwards Lifesciences)...
The use of TriClip (Abbott) for edge-to-edge repair in tricuspid regurgitation (TR) remains safe and effective at one year, preliminary outcomes from the TRILUMINATE study, presented at a late-breaking session at PCR London Valves 2019 (17–19 November, London, UK),...
Permanent pacemaker implantation (PPI) after transcatheter aortic valve implantation (TAVI) is associated with increased mortality at six years, particularly in patients who are pacemaker dependent. At an abstract session at PCR London Valves 2019 (17–19 November, London, UK), Giuliano...
Endotronix has presented first-in-human data of the Cordella pulmonary artery pressure sensor System at the 2019 American Heart Association (AHA) Scientific Sessions (16–18 November, Philadelphia, USA). Data were presented by Wilfried Mullens (Hospital Oost-Limburg, Genk, Belgium). The 90-day results from...
A single-centre real world experience has found that the vast majority of patients with severe mitral regurgitation (MR) were not eligible for inclusion in the COAPT trial, with the most frequent reason for exclusion being that they were not...
Over the past few years, the indications for transcatheter aortic valve implantation (TAVI) have expanded from inoperable patients to low-risk patients—meaning that TAVI can now be considered for all aortic stenosis patients, regardless of their surgical risk.1 However, using...
The mortality risk for patients with critical limb ischaemia (CLI) has not changed over the last few decades, despite advances in cardiovascular medicine that treat myocardial infarction and stroke, the two biggest causes of death in these patients, Sahil...
Shockwave Medical has initiated the DISRUPT CAD IV study of its intravascular lithotripsy (IVL) system with the aim of using data from the study to support regulatory device approval in Japan. The system is used in the management of...
A wrist-based optical blood pressure monitor has the potential to replace cuff monitoring systems for ambulatory blood pressure, suggests a study in the journal Blood Pressure Monitoring. A press release from Aktiia, the Swiss-based company manufacturing the device, states...
The use of multiphase computed tomography (CT) assessment, particularly during the early systolic phase, of the neo-left ventricular outflow tract (LVOT) is a better predictor of clinically relevant obstruction in transcatheter mitral valve replacement (TMVR) than end systole measurements....
A prespecified subgroup analysis of the GLOBAL LEADERS trial has found no between-sex difference in the risk of two-year all-cause mortality or new Q-wave myocardial infarction (MI) following percutaneous coronary intervention (PCI). Published online in JAMA Cardiology, the study...
Left atrial appendage closure (LAAC) via implanted device was associated with a decreased risk of admission for stroke, compared with the expected risk without anticoagulation therapy, according to a study published in the Journal of the American Medical Association...

Ehtisham Mahmud

The 2019–20 president of the Society for Cardiovascular Angiography and Interventions (SCAI) Ehtisham Mahmud (division chief, Cardiovascular Medicine, UC San Diego, San Diego, USA) tells Cardiovascular News about his career highlights, and outlines the key priorities for his presidency. 1....
Patients who have mixed aortic valve disease with pre-existing aortic regurgitation have better survival rates following transcatheter aortic valve implantation (TAVI) than those who have aortic stenosis alone. Writing in JACC: Cardiovascular Interventions, Johnny Chahine (Cleveland Clinic, Cleveland, USA)...
CorFlow Therapeutics has announced that the company has been granted Breakthrough Device designation from the US Food and Drug Administration (FDA) for its Controlled Flow Infusion (CoFI) System. It is indicated for the diagnostic assessment of the coronary microcirculation...
Cardionovum's Restore paclitaxel-coated balloon for coronary applications has received market approval for use in China. It can be used in treating two indications: in-stent restenosis and small vessel disease. A joint press release from Cardionovum and China Grand Pharmaceutical...
The stockholders of Corindus Vascular Robotics have approved the adoption of the agreement and plan of merger that was drawn up in August by Siemens Medical Solutions USA (Siemens Healthineers), Corpus Merger, and Corindus. A press statement reports that...
Further evidence for a shorter duration of dual antiplatelet therapy (DAPT) in patients implanted with a drug eluting stent has been provided with the presentation of two studies at Transcatheter Cardiovascular Therapeutics (TCT 2019; 24–29 September, San Francisco, USA). Data...
Using optical coherence tomography (OCT)-to guide percutaneous coronary intervention (PCI) is associated with a lower occurrence of major adverse cardiac events (MACE) or significant angina in patients with angiographically-intermediate coronary lesions (AICL) than fractional flow reserve (FFR)-guidance. However, FFR...
Different strategies are needed to address the continuing lack of diversity in the US cardiology workforce, say the authors of a cross-sectional study which found that numbers of underrepresented minority individuals and women remain proportionately lower, and that progress...
A study published as a research letter in JAMA Internal Network has found a “substantial misclassification” of patient deaths for the Sapien 3 and MitraClip devices in the US Food and Drug Administration (FDA) database which, the authors say,...
Clinical data presented at the 2019 European Cardio-Thoracic Surgery (EACTS) annual meeting (3-5 October, Lisbon, Portugal), from two prospective trials of the VEST external stent for vein grafts during coronary artery bypass surgery (CABG), showed low major adverse cardiac...
The National Institute for Health and Care Excellence (NICE) has published the final appraisal determination (FAD) recommending the use of Xarelto (rivaroxaban) by the National Health Service (NHS) in England at a dose of 2.5mg twice daily combined with...
Shockwave Medical, a company which provides intravascular lithotripsy (IVL) to treat complex calcified cardiovascular disease, unveiled the results of the DISRUPT CAD II study, a European postmarket study of coronary IVL, in a High Impact Clinical Research session at...
William W Pinsky and Mandeep R Mehra explain to Cardiovascular News how international medical graduates contribute to both their adopted country and their country of origin, providing benefits for all. It should come as no surprise that international medical graduates...
This content is only for readers outside of the US as it discusses a device that is not FDA approved. The PASCAL repair system (Edwards Lifesciences, Irvine, CA, USA) is a novel leaflet repair therapy. The implant uses clasps and...
During a session on radiation protection technologies at the 2019 Transcatheter Cardiovascular Therapeutics (TCT) meeting (25­–29 September, San Francisco, USA), Lloyd W Klein (Rush Medical College, Chicago, USA) said that Henry V led the heavily outnumbered English army to victory at...
Admedus has sold the distribution rights to its CardioCel and VascuCel product range for $A36.2 million to US-based LeMaitre Vascular. A press release from Admedus announces that it will focus on advancing its transcatheter aortic valve implantation (TAVI) programme...
Penumbra has announced the enrolment of the first patient into the CHEETAH study, a prospective, multicentre US study to evaluate the safety and performance of the Indigo System with CAT RX Aspiration Catheter in coronary vessels. A press release from...
Douglas Drachman has been selected as the next vice chair of the American College of Cardiology’s Annual Scientific Session. Drachman will serve as vice chair for two years, at ACC ‘21 and ACC ‘22, and then as chair for...
Cardiothoracic surgeon David Taggart (Department of Cardiac Surgery, University of Oxford, John Radcliffe Hospital, Oxford, UK) told delegates attending the 2019 European Association for Cardio-Thoracic Surgery (EACTS) meeting (3–5 October, Lisbon, Portugal) that the definition of myocardial infarction used...
Abiomed has announced the results of PROTECT III, an ongoing, prospective, single-arm US Food and Drug Administration (FDA) post-market approval (PMA) study for Impella 2.5 and Impella CP in high-risk percutaneous coronary intervention (PCI). PROTECT III follows the PROTECT...
Data from an interim analysis of heart failure patients treated in the CorCinch FMR study show, a press release reports, that the AccuCinch ventricular repair system (Ancora Heart) is associated with a favourable safety profile, with 97% freedom from...
A prespecified analysis of data from the AUGUSTUS study, released at late-breaking session at the Transcatheter Cardiovascular Therapeutics scientific symposium (TCT 2019; 25–29 September, San Francisco, USA) and published online in Circulation, indicate that anticoagulation with apixaban and a...
The Gore Cardioform Occluder for atrial septal defects (ASD) has received CE mark in Europe, the company has announced, stating that the move was supported by data from the Gore ASSURED clinical study. In its press release, Gore points out...
Interest in transseptal puncture has surged with the development of structural interventions for the left side of the heart. Francesco Maisano provides an update on its changing role in modern interventional cardiology. The transseptal puncture (TP) technique was developed in...
Endotronix has announced the expansion of its series D financing round, bringing the total to US$70 million. The expansion syndicate includes new investment from an additional unnamed medical device strategic investor, as well as participation from existing investors. The...
ONYX ONE, the first randomised trial to compare a durable polymer drug-eluting stent to a polymer-free drug-coated stent in patients at high risk of bleeding and treated with one-month dual antiplatelet therapy (DAPT), has found that both are clinically...
A subanalysis of PARTNER 3 quality of life data demonstrated a modest, but significant, improvement in one-year disease-specific quality of life after transcatheter aortic valve implantation (TAVI) compared with surgical aortic valve replacement (SAVR) in low-risk patients with severe...
A timing substudy of the COMPLETE trial has found that, compared with culprit-lesion only percutaneous coronary intervention (PCI), a strategy of non-culprit lesion PCI with the goal of complete revascularisation performed early during index hospitalisation (median one day) or...
The MitraClip device (Abbott) continues to demonstrate safety and efficacy at three years in patients with heart failure and secondary mitral regurgitation (MR), findings from the COAPT trial have shown. In addition, patients who crossed over and received the...
The first randomised trial to compare the safety and efficacy of the Acurate neo transcatheter heart valve (Boston Scientific) with the Sapien 3 TAVI device (Edwards Lifesciences) did not meet non-inferiority in patients with severe aortic stenosis. The findings were...
The Portico IDE study has found that 30-day safety and one-year effectiveness outcomes of a novel self-expanding transcatheter aortic valve implantation (TAVI) system for patients with severe aortic stenosis (AS) at high or extreme-risk for surgery was noninferior to...
Data from the TWILIGHT study demonstrate that, compared to ticagrelor plus aspirin, ticagrelor monotherapy reduces bleeding events without increasing the risk of death, myocardial infarction, or stroke in high-risk patients who have undergone successful percutaneous coronary intervention (PCI) and...

FDA approves Evolut PRO+

The US Food and Drug Administration (FDA) has approved the Evolut PRO+ transcatheter aortic valve implantation (TAVI) system, which a press release states builds off the proven self-expanding, supra-annular Evolut TAVI platform. The press release adds that the Evolut...
In our September issue, we report on the top stories from the 2019 European Society of Cardiology (ESC) congress (31 August–4 September, Paris, France). This includes COMPLETE, ISAR-REACT 5, and BIOSTEMI. We also profile Ehtisham Mahmud.
In our September issue, we report on the top stories from the 2019 European Society of Cardiology (ESC) congress (31 August–4 September, Paris, France). This includes COMPLETE, ISAR-REACT 5, and BIOSTEMI. We also profile Ehtisham Mahmud.
The August issue of Cardiovascular News covers the top stories from EuroPCR 2019, looking at PCR statements on TAVI. We also review stakeholders' response to the updated CMS coverage for TAVI and profile Josep Rodes-Cabau.
The August issue of Cardiovascular News covers the top stories from EuroPCR 2019, looking at PCR statements on TAVI. We also review stakeholders' response to the updated CMS coverage for TAVI and profile Josep Rodes-Cabau.
Ashok Seth (New Delhi, India) talks to BLearning at EuroPCR 2019 (21–24 May, Paris, France) about the MyVal-1 study which looked at the one-year clinical outcomes of India’s first indigenously designed and manufactured TAVR system. This was the first in-human study of the device...
Boston Scientific has announced the key data that will be presented at the Transcatheter Cardiovascular Therapeutics conference (TCT 2019; 25–29 September, San Francisco, USA). Data from the EVOLVE Short DAPT study, evaluating the safety of early dual antiplatelet therapy discontinuation...
Corindus Is to showcase the CorPath GRX system at the Transcatheter Cardiovascular Therapeutics Conference (TCT 2019; 25–29 September, San Francisco, USA). CorPath GRX is the only US Food and Drug Administration (FDA) cleared and CE-marked medical device for robotic-assisted...
Abbott has announced its TRILUMINATE pivotal trial to evaluate the safety and effectiveness of the TriClip transcatheter tricuspid valve repair system for the treatment of severe tricuspid regurgitation. This is the first pivotal Investigational Device Exemption (IDE) trial in...
AtriCure has entered into a definitive agreement to acquire SentreHEART, which developed the LARIAT device for left atrial appendage closure in patients with atrial fibrillation. A press release reports that the transaction consideration consists of an upfront payment of...
Martin Kostelka (Leipzig, Germany), who was the first to use the CardioCel 3D (Admedus) product after it was recently CE marked in Germany, talks to Cardiovascular News about his experience where he implanted the 3D scaffold in a small child, a...
Caution: This content is only for readers outside of France and Japan. In the US, ACURATE neo is limited by U.S. law to investigational use only. Not available for sale. Since the first implant 17 years ago, transcatheter aortic valve...
Omar Ishrak, Medtronic’s chairman and CEO is to retire on 26 April 2020, following the end of the company’s current fiscal year. Also, the Medtronic Board of Directors has announced key leadership appointments as part of its multi-year, leadership...
A new study indicates that the Meridian transcatheter aortic valve implantation (TAVI) valve (HLT) is associated with a 30-day mortality rate of 8% and a six-month mortality rate of 12%. The valve is fully retrievable after deployment, which allows...
Merit Medical Systems, a leading manufacturer and marketer of proprietary devices used primarily in cardiology, radiology, oncology, and endoscopy, has announced the commercial launch of the PreludeSYNC EVO radial compression device in the USA. PreludeSYNC EVO is a sterile,...
Virtual patient care is creating exciting learning opportunities for interventional cardiologists. Atman P. Shah considers how training through gaming can deliver a state-of-the-art profession. Recently, I was between patients, with a few minutes to spare. I opened an app on...
New data from the SwedeHF heart failure registry indicates that the use of an implantable cardioverter defibrillator (ICD) in patients with heart failure with reduced ejection fraction (HFrEF) is associated with a significant reduction in all-cause mortality at both...
At the European Society of Cardiology Congress (ESC 2019; 31 August–4 September, Paris, France), Jean-Francois Obadia (Hopital Cardiovasculaire Louis Pradel, Chirurgie Cardio-Vasculaire et Transplantation Cardiaque, Lyon, France) reported that the two-year results of MITRA-FR indicate that percutaneous edge-to-edge repair...
One-year data from the BIOSTEMI study, simultaneously published in The Lancet and presented at the European Society of Cardiology Congress (ESC 2019; 31 August–4 September, Paris, France), indicate that patients with ST-segment elevation myocardial infarction (STEMI) who undergo percutaneous...
Speaking to Cardiovascular News at the ECHSA 2019 meeting (European Congenital Heart Surgeons Association; 20–22 June; Sofia, Bulgaria), Guido Michielon (London, UK) says that the CardioCel bioscaffold (Admedus) has a wide application from neonatal age to paediatric age. The main advantage is that...
This morning at the 2019 European Society of Cardiology (ESC) Congress (31 August–4 September, Paris, France), Pavel Osmancik (Charles University and University Hospital Kralovske Vinohrady, Prague, Czech Republic) presented the results of PRAGUE-17. These showed that left atrial appendage...
A strategy of complete revascularisation was superior to culprit lesion-only percutaneous coronary intervention (PCI) in reducing the risk of cardiovascular death or myocardial infarction (MI) in patients with ST-segment myocardial infarction (STEMI) and multivessel coronary artery disease. The timing...
Stefanie Schüpke (Deutsches Herzzentrum München, and Technische Universität München, Munich, Germany) told ESC delegates today that using prasugrel rather than ticagrelor to treat patients with acute coronary syndromes is associated with a significant reduction in the incidence of death,...
At the 2019 European Society Cardiology (ESC) congress (31 August – 4 September, Paris, France), Abiomed revealed that its Impella CP with SmartAssist technology is now commercially available in Europe. A press release reports that the system is designed to...
Giovanni Stellin (Padova, Italy) talks to Cardiovascular News at the ECHSA 2019 meeting (European Congenital Heart Surgeons Association; 20–22 June; Sofia, Bulgaria) about his own experience with the CardioCel (Admedus) bioscaffold which he found “excellent in reconstructing part of the heart in small...
Although renal denervation may not hit the heights originally envisaged for it in the management of hypertension, and areas of uncertainty remain, Partha Sardar and Herb Aronow explain why they believe that it has the potential become a mainstream...
A polypill that combines four cardiovascular drugs has been shown to reduce the risk of major cardiovascular events in the general population when taken in a low-dose once-daily. Findings from the PolyIran study, a five-year randomised controlled trial, were...
AstraZeneca has announced positive results from the Phase III DAPA-HF trial which showed that FARXIGA (dapagliflozin) met the primary composite endpoint with a statistically-significant and clinically-meaningful reduction of cardiovascular death or the worsening of heart failure (defined as hospitalisation...
CeloNova has announced the appointment of Carl J St. Bernard as president and chief executive officer (CEO). According to CeloNova, St. Bernard joins the company from Tryton Medical where he was president and CEO, leading the company’s commercialisation efforts in...
The US Food and Drug Administration has approved the Barostim Neo system for the improvement of symptoms in patients with advanced heart failure who are not suited for treatment with other heart failure devices, such as cardiac resynchronisation therapy....
Horst Sievert (Frankfurt, Germany) talks to BLearning at EuroPCR 2019 (21–24 May, Paris, France) about the VECTOR-HF trial which evaluated the safety, usability and performance of a novel wireless pressure monitoring system in adult patients with New York Heart Association (NYHA) Class III Heart Failure...
According to a BIBA MedTech survey, 52% of neurointerventionalists believe that they are the only specialists who have the relevant skills and experience to perform interventional stroke procedures (e.g. mechanical thrombectomy). However, of those who believe other specialities—with the appropriate...
On 16 August, the US Food and Drug Administration (FDA) approved Edwards Lifesciences’ Sapien 3 and Sapien 3 Ultra and Medtronic’s Evolut R and Evolut PRO transcatheter aortic valve implantation (TAVI) systems for the management of low-risk patients. However,...
Edwards Lifesciences—in a press statement announcing its global second quarter (Q2) financial results—has revealed that it is taking the self-expanding transcatheter aortic valve implantation (TAVI) device Centera off the market. The company says resources will instead be focused on...
The Cardiovascular Research Foundation (CRF) has announced the 12 late-breaking trials and 16 late-breaking science presentations that will be reported at the Transcatheter Cardiovascular Therapeutics (TCT) 2019 scientific symposium. TCT, the world’s premier educational meeting specialising in interventional cardiovascular...
The Myval transcatheter aortic valve implantation (TAVI) system, designed and manufactured by Meril Lifesciences in India, recently received the CE mark for the management of severe aortic stenosis. In this commentary, Ashok Seth discusses his experience with the Myval...
 Tomasz Mroczek (Kraków, Poland) talks to Cardiovascular News at ECHSA 2019 (European Congenital Heart Surgeons Association, 20 – 22 June, Sofia, Bulgaria) – where the management of critically ill infants was a hot topic – about using CardioCel (Admedus)...
Cardiovascular Systems recently announced that it has acquired the Wirion embolic protection system and related assets from Gardia Medical. The device, which received CE Mark in June 2015 and US Food and Drug Administration (FDA) clearance in March 2018, is...
Data from two new studies suggest that transcatheter tricuspid valve repair (TTVr) is a safe and effective treatment option for patients with symptomatic or severe tricuspid regurgitation (TR) who are not suitable for surgery. Both were published in JACC:...
Hormone replacement therapy is a common treatment for menopause-related symptoms, and new research from the University of Pittsburgh Graduate School of Public Health (Pittsburgh, USA) reinforces the importance of tailoring hormone therapy to each patient, based on her individual risk...
B Braun Interventional Systems has announced that the US Food and Drug Administration (FDA) has granted breakthrough device designation for the SeQuent Please ReX drug-coated PTCA balloon catheter for the treatment of coronary in-stent restenosis (ISR). SeQuent Please ReX is...
The National Institute for Health and Care Excellence (NICE) in the UK has published a positive draft final appraisal determination recommending the use of rivaroxaban (brand name Xarelto, Bayer) by the National Health Service (NHS) in England. The NICE...
Ulrich Schäfer (Hamburg, Germany) speaks to Cardiovascular News at EuroPCR (21–24 May, Paris) about the VIVALL study which looked at the safety and efficacy of the replacement of failed surgical bioprosthetic aortic valves with the Allegra Transcatheter Heart Valve...
Caner Salih (London, UK) talks to Cardiovascular News about the CardioCel bioscaffold (Admedus) and the benefits it has brought to his practice at Guy's and St Thomas’ hospital. According to Salih, CardioCel has become the “tissue of choice” and he...
The clinical frailty score currently used to assess suitability for transcatheter aortic valve implantation (TAVI) requires further refinement, a study published in the American Journal of Cardiology has concluded. However, the investigators also say that patients aged ≥90 years...
Patients whose prescription for PCSK9 inhibitors (proprotein convertase subtilisin kexin type 9 inhibitors) are either unfilled or rejected by insurance companies have a higher rate of cardiovascular events than those whose prescriptions are paid for. Kelly D Myers (The...
Recent low-risk trials for TAVI look set to expand its indications for use. Amar Krishnaswamy and Samir Kapadia assess the impact of the findings on everyday practice, and look at areas where uncertainties remain. Transcatheter aortic valve implantation (TAVI) is...
Medtronic has entered into a partnership agreement with Viz.ai to accelerate the adoption of artificial intelligence software for stroke prevention and treatment in US centres. A press release from Medtronic announced the collaboration, describing Viz.ai as “the emerging leader...
The first patient has been randomised in the TARGET BP I trial at the Piedmont Heart Institute in Atlanta, USA, to investigate the use of the Peregrine System Kit (Ablative Solutions) in renal denervation. Target BP I is a blinded,...
Edwards Lifesciences has announced it has made the “difficult decision” to discontinue its self-expanding transcatheter aortic valve implantation (TAVI) device Centera. The company says the resources required to “optimise deliverability as well as expanding the indications to match the...
Edwards Lifesciences has issued an urgent safety notice for the latest generation of its Sapien device, Sapien 3 Ultra, after it received reports of “burst balloons, which have resulted in significant difficulty retrieving the Sapien 3 Ultra delivery system...
According to a statement, Abbott has announced it has received US Food and Drug Administration (FDA) approval for the fourth-generation MitraClip heart valve repair device to treat mitral regurgitation. The latest approval for MitraClip G4, puts new enhancements into...
Women who suffer from idiopathic intracranial hypertension (IIH) have twice the risk of heart conditions and stroke than those of the same age and body mass index (BMI) who do not have IIH, a study published in JAMA Neurology...
Five-year results suggest that surgical aortic valve replacement (SAVR) is associated with lower rates of mortality and major adverse cardiac and cerebrovascular events (MACCE) than transfemoral transcatheter aortic valve replacement (TAVI) performed using first-generation devices in low- and intermediate-risk...
Speaking to Cardiovascular News at EuroPCR 2019 (21–24 May, Paris, France), Georg Nickenig (Bonn, Germany), discusses the results of the TRILUMINATE trial which looked at the safety and efficacy of treating tricuspid regurgitation with a novel tricuspid valve repair...
Thanks to the use of robotics in healthcare, many procedures that were once highly invasive are now being performed using minimally invasive techniques, with the added benefits of precision and radiation protection. Jean Fajadet looks at how the technology...
  Cardiac Dimensions has announced in a press release that its Carillon Mitral Contour System has now been implanted in 1,000 patients in the USA, Europe, Australia, Turkey, and the Middle East. The Carillon System is a right-heart transcatheter mitral...
  Medtronic has announced plans for a global registry of its HeartWare HVAD System, following the release of two-year outcomes from the LATERAL clinical trial. The HVAD System is a left ventricular assist device (LVAD) that helps increase the amount...
FEops has won the CSI Frankfurt 2019’s Highlight of the Year Award for its FEops HEARTguide under the category of interventional imaging. A press release reports that this award celebrates promising technologies that will have the biggest impact in...
After receiving reports of difficulty tracking and manipulating the Centera transcatheter aortic valve implantation (TAVI) system around the aortic arch, Edwards Lifesciences has issued an urgent safety notice. The notice states that these difficulties have “resulted in vascular injury...
The Liverpool Centre for Cardiovascular Science, an alliance between academia and the NHS, was established to advance cardiovascular and stroke research and innovation locally, nationally, and internationally. The director of the centre, Professor Gregory YH Lip, Price-Evans chair of...
Data from the MeRes-1 and MeRes-1 Extend clinical trials, released at EuroPCR 2019 (20–24 May, Paris, France), demonstrate sustained efficacy and safety for the recently CE-approved MeRes100 (Meril) bioresorbable scaffold (BRS). A press release from Meril describes it as a...
Admedus has announced positive data from an independent study into the performance of its tissue engineered bovine pericardial implant CardioCel, which is used in the repair of congenital heart defects in children. Published in The Annals of Thoracic Surgery, the...
PASCAL’s (Edwards Lifesciences) safety and efficacy may rival that of MitraClip (Abbott) for the treatment of mitral regurgitation (MR), according to data published in JACC: Cardiovascular Interventions. Fabien Praz, Stephan Windecker (University Hospital Bern, Bern, Switzerland), and Samir Kapadia...
The National Institute for Health and Care Excellence (NICE) has released evidence-based recommendations on the percutaneous insertion of a cerebral protection device to prevent cerebral embolism during transcatheter aortic valve implantation (TAVI). It says that the evidence on percutaneous insertion...
Zoll Medical, an Asahi Kasei Group Company that manufactures medical devices and related software solutions, has acquired TherOx—a company on improving treatment of acute myocardial infarction and markets systems to deliver super saturated oxygen (SSO2) therapy. A press release reports...
Valix Medical has received a US patent—10,278,820 (percutaneous valve repair and replacement)—for its heart valve repair and replacement technology. A press release reports that the company is developing transcatheter solutions for patients suffering from valvular heart disease and heart...
Robocath has announced that that the well-known interventional cardiologists Michael Haude, Faziel Lorgat, and Holger Nef have joined its medical advisory board. Founded in 2009 by Philippe Bencteux, Robocath designs, develops and commercializes robotic solutions to treat cardiovascular diseases;...
A Philips press release reports both the EPIQ CVx and EPIQ CVxi now include automated applications for 2D assessment of the heart, as well as robust 3D right ventricle volume and ejection fraction measurements—with the aim of making accurate...
One-year data for the Myval transcatheter aortic valve implantation (TAVI) system indicate it is associated with 100% freedom from device related mortality at one year. These data, which were presented at EuroPCR 2019 (21–24 May, Paris, France) also showed...
Siemens Healthineers and Mentice have announced a collaboration to fully integrate Mentice’s Vist “Virtual Patient” into the Artis icono angiography system from Siemens Healthineers. A press release reports that the Vist Virtual Patient, thus, becomes a fully integrated simulation...
New data show that the use of the investigational HeartFlow Planner—a real-time, non-invasive interactive planning tool—led to a change in treatment strategy in 45% of patients with coronary artery disease and reduced the need for invasive physiology. The data from the...
Royal DSM is to collaborate with Strait Access Technologies (SAT) to develop the world’s first durable and cost-effective transcatheter replacement heart valves with polymeric leaflets. This collaboration is initially focused on developing valves to treat rheumatic heart disease. A press...
The Centers for Medicare & Medicaid Services (CMS) has finalised its update the US coverage for transcatheter aortic valve implantation (TAVI). It will continue to provide coverage with evidence development when furnished according to an FDA-approved indication. However, it...
The OPTION trial is to compare the compare safety and effectiveness of the next-generation Watchman FLX left atrial appendage closure platform with first-line oral anticoagulants—including direct oral anticoagulants and warfarin—for stroke risk reduction in patients with non-valvular atrial fibrillation...
A company providing what a press release calls “next-generation electrophysiology technology solutions” has announced that it now has US$170m financing. The press release reports that this includes a US$100 million Series D equity financing and a US$70 million credit...