Tag: TAVI

SCCT releases new guideline for use of computed tomography in TAVR...

The Society of Cardiovascular Computed Tomography (SCCT) has released a new expert consensus document for computed tomography imaging to improve outcomes for patients undergoing...

Combination of high-sensitive C-reactive protein with logistic EuroSCORE improves risk stratification...

According to Anja Stundl (Department of Medicine II, Heart Center Bonn, University Hospital, Bonn, Germany) and others, high-sensitive C-reactive protein (hs-CRP) can be used...

SCAI 2018: 3D model could be used to predict paravalvular leak...

A new study presented at the 2018 Society for Cardiovascular Angiography and Interventions (SCAI) Scientific Sessions (25–28 April, San Diego, USA) indicates 3D printing...

TAVI is increasingly seen as the preferred approach for aortic valve...

A review of the trends in the use and propensity-matched analysis of in-hospital outcomes, published in Circulation: Cardiovascular Interventions, indicates that the number of...

“Favourable” in-hospital outcomes for younger patients undergoing TAVI

Registry data for younger patients—under 75 years—undergoing transcatheter aortic valve implantation (TAVI) is associated with similar in-hospital outcomes to propensity-matched patients undergoing surgical aortic...

Depression significantly increases mortality after aortic valve replacement

Data from the FRALITY-AVR (Frality aortic valve replacement) study suggest that the presence of depression in patients undergoing aortic valve replacement—either via surgery or...

Next-day discharge appears safe for TAVI patients without in-hospital complications

Patients who undergo transfemoral transcatheter aortic valve implantation (TAVI) with a minimalist approach and who are discharged the day after the procedure have similar...

Modifying procedural technique during TAVI may lower radiation exposure to patients

Andrew Goldsweig (Division of Cardiology, University of Nebraska Medical Center, Omaha, USA) and others report in Catheterization and Cardiovascular Interventions that eight factors are...

Claret Medical closes on series C financing of US$14.5m

Claret Medical has announced that it has closed on a series C financing of US$14.5m led by Lightstone Ventures, with participation from existing investors...

Relatively few chronic kidney disease patients require dialysis after TAVI

James W Hansen (Lahey Hospital and Medical Center, Burlington, USA) and others report in JACC: Cardiovascular Interventions that the number of patients with chronic...

No significant differences in post TAVI outcomes between African Americans and...

Fahad Alqahtani (Division of Cardiology, West Virginia University Heart & Vascular Institute, Morgantown, USA) and others report in Catheterization and Cardiovascular Interventions that there...

All-comers data indicate stroke-free survival is improved with Sentinel embolic protection...

Jochen Wöhrle (Department of Internal Medicine II, Cardiology, University of Ulm, Ulm, Germany) and his team report in JACC: Cardiovascular Interventions that, in an...

ESC 2017: Post-TAVI clinical leaflet thrombosis is “infrequently reported” but is...

Of 5,691 adverse events following transcatheter aortic valve implantation (TAVI) that were reported to the FDA’s manufacturer and user facility device experience (MAUDE) database,...

ProtEmbo cerebral protection system used for first time

The ProtEmbo cerebral protection system (Protembis) has been used, to complement a transcatheter aortic valve implantation (TAVI) procedure, for the first time in a...

CE mark for CoreValve Evolut Pro

Medtronic has received the CE mark for its CoreValve Evolut Pro valve for the treatment of severe aortic stenosis for symptomatic patients who are...

EuroPCR 2017: A “golden era” for valve disease therapies

At this year’s EuroPCR (16–19 May, Paris, France), Philip MacCarthy writes, I had the pleasure of welcoming onto the podium a team of determined cyclists...

Embolic protection device company raises US$5million in series B financing for...

Innovative Cardiovascular Solutions has announced today completion of an oversubscribed Series B round of financing totalling US$5M. The company is currently developing the Emblok...

CoreValve Evolut can be used to treat intermediate-risk patients in the...

Medtronic has announced that the FDA has approved the company’s self-expanding transcatheter aortic valve implantation (TAVI) system CoreValve Evolut for the management of intermediate-risk...

Essential Frailty Toolset may be best assessment of frailty for aortic...

Jonathan Afilalo (Division of Cardiology, Jewish General Hospital, McGill University, Montreal, Canada) and others report in the Journal of American College of Cardiology that...

Unique 3D-printed heart valves could reduce TAVI paravalvular leakage rates

Researchers at Georgia Institute of Technology and the Piedmont Heart Institute (both Atlanta, USA) are using standard medical imaging and new 3-D printing technologies...

Nearly one in 10 US TAVI procedures is off label but...

Ravi S Hira (Section of Cardiology, University of Washington, Seattle, USA) and others report in JAMA Cardiology that 9.5% of US transcatheter aortic valve...

EuroPCR 2017: Study provides “first step” towards showing long-term durability of...

New data presented, by Luca Testa (Department of Cardiology, IRCCS Policlinico S. Donato, Milan, Italy), at EuroPCR (16–19 May, Paris, France) indicates that there...

Study confirms that volume matters for achieving lower in-hospital mortality after...

A study, published in EuroIntervention, provides further evidence that there is an inverse relationship between the number of transcatheter aortic valve implantation (TAVI) procedures...

Bicuspid aortic stenosis: TAVI’s next challenge

Most of the initial registries, and the large randomised trials, for transcatheter aortic valve implantation (TAVI) excluded patients with bicuspid aortic valves. The presence...

EuroPCR 2017: Greater risks with standard approach of dual antiplatelet therapy...

The ARTE study, which was simultaneously presented at EuroPCR (16–19 May, Paris, France) and published in JACC: Cardiovascular Interventions, indicates that dual antiplatelet therapy...

TVT 2017: Presentation showcases safety of Tempo temporary pacing lead

BioTrace Medical announced that its Tempo temporary pacing lead was featured in an oral presentation during the 2017 Transcatheter Valve Therapies (TVT) meeting (14–17...

US centres of TAVI excellence start to use newly approved Sentinel...

Claret Medical has announced that several of the largest centres of excellence for transcatheter aortic valve implantation (TAVI) have now performed the first US...

HLT’s TAVI system implanted in first US patients

The first patients in an early feasibility study of HLT’s transcatheter aortic valve implantation (TAVI) system have been implanted with the device. The implant...

TVT 2017: “I predict a very exciting and bright future” for...

This year marks the 10th anniversary of the Transcatheter Valve Therapies (TVT) meeting (14–17 June, Chicago, USA). Course director Martin B Leon (Interventional Vascular...

Sentinel becomes first cerebral protection device to receive FDA approval

Claret Medical has received regulatory clearance from the FDA for its Sentinel cerebral protection system, via de novo classification, meaning that the device can...

EuroPCR 2017: Excellent early outcomes for Edwards Lifesciences’ self-expanding valve

According to late-breaking trial presented at EuroPCR (16–19 May, Paris, France), a novel self-expanding transcatheter aortic valve implantation device (TAVI, Centera, Edward Lifesciences) is...

EuroPCR 2017: Lotus TAVI device has superior efficacy to CoreValve at...

Data from the REPRISE III trial indicate that the Lotus transcatheter aortic valve implantation (TAVI) device (Boston Scientific) is associated with a significantly lower...

Boston Scientific closes Symetis acquisition

Boston Scientific Corporation has announced the close of its acquisition of Symetis SA, a privately-held Swiss structural heart company focused on transcatheter aortic valve...

The role of nurses in ensuring a patient-focused TAVI service

Preadmission clinics for patients awaiting elective procedures or surgery are not a new concept. Over the years, several studies have highlighted the multiple benefits...

Reduced baseline left ventricular function may explain female survival benefit after...

A new study indicates that the apparent survival benefit after transcatheter aortic valve implantation (TAVI) that women have over men relates to the baseline...

Daiichi Sankyo initiates ENVISAGE-TAVI AF study to investigate once-daily edoxaban in...

The ENVISAGE-TAVI AF is the first study to evaluate the effects of a novel oral anticoagulant on clinical outcomes exclusively in atrial fibrillation patients...

Meta-analysis supports transaortic approach in TAVI

A meta-analysis of single-centre studies indicates that the use of the transaortic appraoch in patients undergoing transcatheter aortic valve implantation (TAVI) is associated with...

First patients enrolled in HLT’s Meridian transcatheter aortic valve feasibility study

HLT has announced that the first patient implants in a feasibility clinical study to assess the safety and performance outcomes of its Meridian transcatheter...

CE mark granted to NVT for Allegra transcatheter aortic valve

NVT has received the CE mark for its Allegra transcatheter aortic valve, which it describes as “distinctive” in a company release. The product features...

Boston Scientific agrees to acquire Symetis

Boston Scientific Corporation have definitively agreed to acquire Symetis, a privately-held Swiss structural heart company focused on minimally-invasive transcatheter aortic valve implantation devices, for...

TAVI pacemaker issue is “an engineering problem that will be solved”

The SURTAVI trial indicates that transcatheter aortic valve implantation (TAVI)  with CoreValve/CoreValve Evolut R (Medtronic) is non-inferior to surgery for the management of severe...

ACC 2017: FDA approves launch of CoreValve Evolut Pro

The FDA has approved Medtronic’s CoreValve Evolut Pro transcatheter aortic valve implantation (TAVI) device. This approval follows data for the device that were presented...

ACC 2017: TAVI Linked with bleeding in the brain and neurological...

Of 84 older patients undergoing transcatheter aortic valve implantationt (TAVI), nearly a quarter developed new microbleeds in the brain after their procedure, according to...

TAVI may benefit certain heart valve patients, update society guidelines say

New recommendations have been published by the American Heart Association and the American College of Cardiology, aiming to clarify which patients who have malfunctioning...

ACC 2017: No significant differences in two-year morality between bicuspid and...

Sung-Han Yoon (Cedars-Sinai Heart Institute, Los Angeles, USA) and others report in the Journal of the American College of Cardiology that all-cause mortality at...

ACC 2017: CoreValve non-inferior to surgery in intermediate-risk patients

Results from the SURTAVI clinical trial, which were presented today at the 2017 scientific sessions of the American College of Cardiology (17–19 March, Washington,...

Innovative Cardiovascular Solutions announces successful first use of its Emblok embolic...

  Innovative Cardiovascular Solutions has announced the successful first European clinical cases using its Emblok embolic protection system in patients undergoing transcatheter aortic valve implantation...

Early hospital discharge after TAVI less likely in women

A study, published in the Journal of Interventional Cardiology, indicates that females, bleeding, and blood transfusions—among others—are associated with lower odds for an early...

Valve replacement may better than vavluloplasty for aortic stenosis patients with...

A new study published in Catheterization and Cardiovascular Interventions indicates that valve replacement, via surgery or transcatheter aortic valve implantation (TAVI), significantly increases survival...

FDA advisory panel recommend de novo approval of Sentinel cerebral protection...

In an open public hearing of the FDA’s circulatory system devices panel, according to a press release, nearly all panel members recommended the de...

Locking mechanism problems prompt Boston Scientific to recall all ranges of...

According to Reuters, Boston Scientific is recalling all ranges of its transcatheter aortic valve implantation (TAVI) device Lotus. The news agency reports that the...

New guidelines released to improve stroke reporting following cardiac procedures

In response to a growing body of evidence of the existence of "covert" brain injury to patients undergoing transcatheter aortic valve implantation (TAVI) and...

Meta-analysis indicates embolic protection does reduce stroke after TAVI

In a research letter published in the Journal of the American College of Cardiology, Gennaro Giustino (The Icahn School of Medicine, Mount Sinai Hospital,...

Positive results for heart surgery in elderly aortic stenosis patients

Elderly patients with aortic stenosis and medium surgical risk experienced better than expected results after undergoing traditional surgical aortic valve replacement, according to research...

Left atrial appendage thrombus may increase the risk of stroke after...

Sonny Palmer (St Vincent’s Hospital, Melbourne, Australia) and others report in JACC: Cardiovascular Interventions that left atrial appendage thrombus, as identified with computed tomography...

Medtronic receives CE mark for 34mm size CoreValve Evolut R

The CE mark has been granted to Medtronic for the 34mm-valve version of its CoreValve Evolut R, the largest sized transcatheter aortic valve implantation...

TAVI company Direct Flow Medical closes after failing to secure funding

Direct Flow Medical, which markets a CE-marked transcatheter aortic valve implantation (TAVI) device, has closed after funding from a Chinese pharmaceutical company did not...

The management of leaflet thickening after TAVI remains controversial

Ryo Yanagisawa (Department of Cardiology, Keio University School of Medicine, Tokyo, Japan) and colleagues report in JACC: Cardiovascular Imaging that hypoattenuated leaflet thickening after...

New AHA/ACC guidance released for TAVI

A new expert consensus decision pathway will assist clinicians and hospitals in assessing patients’ eligibility for transcatheter aortic valve implantation (TAVI), performing the procedure...

Perform PCI prior to TAVI in patients with both coronary artery...

Stephen Ramee (Ochsner Medical Center, New Orleans, USA) and others outline in a paper in JACC: Cardiovascular Interventions, the rationale for performing percutaneous coronary...

Women fare better than men one year after transcatheter aortic valve...

Women with significant aortic valve disease who undergo transcatheter aortic valve implantation (TAVI) have been traditionally considered at a higher risk than men in...

Minimally invasive TAVI has “several potential benefits”

Recently, there has been a move towards transcatheter aortic valve implantation (TAVI) procedures that are more “minimally invasive”. In this interview, Jay Giri (Cardiovascular...

Pacemaker after TAVI is associated with worse outcomes

A study in JACC: Cardiovascular Interventions indicates that patients who require a pacemaker after undergoing transcatheter aortic valve implantation (TAVI) often have worse outcomes...

NICE should develop heart valve guidelines says Heart Valve Voice

UK charity Heart Valve Voice has launched a report—Towards a Heart Healthy Future: a 2020 Vision for Heart Valve Disease’—that sets out recommendations to...

TCT 2016: SENTINEL trial fails to meet overall primary efficacy endpoint...

The SENTINEL trial, which was presented at the 2016 Transcatheter Cardiovascular Therapeutics (TCT) meeting (29 October-2 November, Washington , DC, USA) today, has not...

TCT 2016: Positive real-world data for CoreValve Evolut R presented

Today, Medtronic presented new positive data from two large registries aimed at evaluating 30-day clinical performance outcomes for its self-expanding, recapturable and repositionable CoreValve...

FDA clear temporary pacing lead for use during TAVI and other...

BioTrace Medical has received FDA 510(k) clearance for its Tempo Lead, which a press release describes as an innovative temporary pacing lead that has...

TAVI is “technically feasible” for managing aortic regurgitation in high-risk patients

Anna Franzone (Department of Cardiology, Swiss Cardiovascular Center, University Hospital, Bern, Switzerland) and others report in the JACC: Cardiovascular Interventions that transcatheter aortic valve implantation...

TAVI at the end of life: Knowing when it is futile

Understanding how aggressively to treat patients in their last years of life is challenging for a number of reasons. Beyond the difficulty of predicting...

Simplified TAVI device may benefit patients with rheumatic heart disease

At the South Africa Heart Association annual congress (8–11 September, Cape Town, South Africa), Jacques Scherman (Chris Barnard Division of Cardiothoracic Surgery, Groote Schuur...

PCRLV 2016: New approaches to TAVI are still being explored

Although much of the innovation in transcatheter solutions for structural heart disease is now focused on mitral and tricuspid approaches, novel devices for transcatheter...

TriGuard cerebral protection associated with significant improvements in brain protection in...

Preliminary real-world findings, presented at PCR London Valves (18–20 September, London, UK), indicate that the use of the cerebral protection device (TriGuard, Keystone Heart)...

Claret Medical submits application for FDA approval of its cerebral protection...

Claret Medical has announced its filing of a marketing application with the FDA for clearance of the Sentinel cerebral protection system. According to a...

Sapien 3 now approved for intermediate-risk patients in Europe as well...

Following last month’s FDA approval for the expanded indication of Sapien 3 for the treatment of intermediate-risk patients with aortic stenosis, the device can...

PCRLV 2016: Next-generation of Lotus TAVI receives CE mark

Coinciding with PCR London Valves (18-20 September, London, UK), Boston Scientific has announced it has received the CE mark for its Lotus Edge transcatheter...

TCT 2016: Pivotal trial on cerebral protection device to be presented...

Data from the SENTINEL pivotal IDE trial will be presented during a late-breaking trial session at the  2016 Transcatheter Cardiovascular Therapeutics (TCT) meeting (29...

Redo TAVI procedures are safe and feasible

Marco Barbanti (Ferrarotto Hospital, University of Catania, Catania, Italy) and others report in Circulation: Cardiovascular Interventions that “redo” transcatheter aortic valve implantation (TAVI)—using TAVI...

“Keep it fast and simple” to avoid periprocedural stroke after TAVI

At PCR London Valves (18–20 September, London, UK), Holger Eggebrecht (Cardioangiological Center Bethanien and AGAPLESION Bethanien Hospital, Frankfurt, Germany) will give the talk “Preventing...

Vivasure Medical secures €16.2 million series C financing

Vivasure Medical has announced that the company has completed a series C financing of €16.2 million. The round was led by LSP (Life Sciences Partners)...

Edwards Sapien 3 granted expanded indication from US FDA

Edwards Lifesciences has announced US Food and Drug Administration (FDA) approval to expand use of the Edwards Sapien 3 transcatheter heart valve for the...

CE mark granted to InSeal Medical for InClosure vascular closure device

InSeal Medical has received CE mark approval for its InClosure VCD; a large bore vascular closure device. According to a press release, the InClosure...

Boston Scientific issues urgent recall of Lotus systems manufactured prior to...

Boston Scientific has sent a letter to its customers notifying them that it is implementing a “voluntary Field Safety Corrective Action (FSCA)” for its...

Medtronic CoreValve Evolut becomes first TAVI to receive CE mark for...

Medtronic has received CE marking for the self-expanding, recapturable and repositionable CoreValve Evolut R system to treat aortic stenosis patients who are at intermediate...

What is required for TAVI to become the new gold standard?

Since its introduction into clinical practice, transcatheter aortic valve implantation (TAVI) has revolutionised the treatment of aortic stenosis and has entered international guideline recommendations.1,2...

TAVI with Sapien 3 may be better than surgery for intermediate-risk...

A ccording to Vinod H Thourani (Emory University School of Medicine, Atlanta, USA) and others, intermediate-risk patients undergoing transcatheter aortic valve implantation (TAVI) with the...

Moderate sedation during TAVI associated with significantly better outcomes

Jay Giri (Cardiovascular Medicine Division, Hospital of the University of Pennsylvania, Philadelphia, USA) reported at the annual meeting of the Society for Cardiac Angiography...