TAVI: Study prompts FDA notice on blood clot risk

A small study published yesterday in the New England Journal of Medicine, finding reduced leaflet mobility in some replacement heart valves, prompted the FDA to caution doctors about the risk of blood clots on the devices. The finding is notable because it involves both transcatheter aortic heart implants and surgical aortic valve implants, which have been in use for roughly 30 years. The researchers looked at data from St. Jude Medical‘s (NYSE:STJ) investigational device exemption trial for its Portico TAVI device and a pair of registry studies following patients treated with TAVI and SAVI devices. Examining CT scans from all 3 trials, they found reduced leaflet mobility in 22 of 55 (40%) patients in the Portico trial and 17 of 132 patients (13%) in the registries. In the Portico IDE trial, all of the 11 patients treated with the anti-coagulation drug warfarin showed restored leaflet motion, according to the NEJM study. The FDA said it still believes that the valves “remain reasonably safe and effective when used according to their approved indications,” but said that follow-up CT scans or transesophageal echocardiographies may be warranted. “These reports have raised important questions about bioprosthetic aortic valves. However, limited available data do not allow us to fully characterize the causes, incidence, and short and long-term risks of reduced valve leaflet motion, or to recommend appropriate treatment. The FDA is wo...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Cardiovascular Clinical Trials Food & Drug Administration (FDA) Regulatory/Compliance Replacement Heart Valves Edwards Lifesciences St. Jude Medical Source Type: news

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(Wyss Institute for Biologically Inspired Engineering at Harvard) Researchers at the Wyss Institute have created a novel 3D printing workflow that allows cardiologists to evaluate how different valve sizes will interact with each patient's unique anatomy, before the medical procedure is actually performed. This protocol uses CT scan data to produce physical models of individual patients' aortic valves, in addition to a 'sizer' device to determine the perfect replacement valve size.
Source: EurekAlert! - Medicine and Health - Category: International Medicine & Public Health Source Type: news
At this week’s Computer Assisted Radiology and Surgery conference (CARS 2018) in Berlin, scientists from the Fraunhofer Institute for Medical Image Computing in Germany will be showing off their unique software that helps to fix cardiac va...
Source: Medgadget - Category: Medical Devices Authors: Tags: Cardiac Surgery Cardiology Radiology Source Type: blogs
Tal Golesworthy is the inventor of the ExoVasc, a bespoke implant that supports the aortic root when it has becomes weak and dilated. Tal’s invention was born out of his personal need for the device to support his aorta that was expanding dange...
Source: Medgadget - Category: Medical Devices Authors: Tags: Cardiac Surgery Cardiology Exclusive Source Type: blogs
CONCLUSIONS: In different studies reported in the literature, 18F-FDG PET/CT proved to improve the diagnostic accuracy of the conventional modified DUKE criteria in patients with suspected IE, and in particular with PVE, giving the highest diagnostic performance and providing additional diagnostic benefits. Thus, the radioisotopic hybrid procedure should be included in the diagnostic protocol of PVE as complementary tool to modified DUKE criteria. Finally, the usefulness of 18F-FDG PET/CT in monitoring the response to antibiotic therapy, although the few data reported in the literature are encouraging, needs more numerous ...
Source: European Review for Medical and Pharmacological Sciences - Category: Drugs & Pharmacology Tags: Eur Rev Med Pharmacol Sci Source Type: research
Implanting prosthetic heart valves is a challenge requiring careful matching of the implanted device to the patient anatomy, as well as placing the implant so that there are no leaks, hemodynamic occlusions, nor a configuration that promotes clot for...
Source: Medgadget - Category: Medical Devices Authors: Tags: Cardiac Surgery Cardiology Source Type: blogs
(MediaSource) Engineers are exploring applications for 3-D printers in the medical field, and the newest research is now going from the lab to the operating room. Experts at The Ohio State University Wexner Medical Center use CT scans to model a patient's aorta, then create a 3D-printed replica down to its exact texture based on the calcification in a patient's tissue.
Source: EurekAlert! - Social and Behavioral Science - Category: International Medicine & Public Health Source Type: news
LivaNova (NSDQ:LIVN) announced today that the first patient has been enrolled in a post-market trial evaluating the overall incidence of reduced leaflet motion identified by CT imaging in patients receiving a bioprosthetic aortic heart valve. Four-dimensional CT scans will be taken of the trial’s 230 participants at least 30 days after they stop anticoagulation or dual antiplatelet therapy, according to LivaNova. The study will also include one year of follow-up. “Thrombus formation on valve leaflets has been shown to occur in some patients receiving prosthetic tissue valve replacement via transcatheter or...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cardiovascular Clinical Trials Imaging Wall Street Beat LivaNova Source Type: news
Rationale: Fever of unknown origin (FUO) can be determined by different conditions among which infectious diseases represent the main cause. Patient concerns: A young woman, with a history of aortic stenosis, was admitted to our unit for a month of intermittent fever associated with a new diastolic heart murmur and splenomegaly. Laboratory tests were negative for infectious screening. The total body computed tomography (CT) scan excluded abscesses, occulted neoplasia, or lymphadenopathy. Diagnoses: The transthoracic and transesophageal echocardiogram showed an aortic valve vegetation. Three sets of blood cultures w...
Source: Medicine - Category: Internal Medicine Tags: Research Article: Clinical Case Report Source Type: research
CONCLUSIONS: Based on experience acquired in the operating room, the acute-angle subcommissural triangles were considered normal, the equilateral triangles mildly dilated, and the obtuse triangles severely dilated. According to this classification, different reparative approaches were selected. A CTscan 3D reconstruction method, as validated by the present data, allows a preoperative evaluation of the triangles and VAJ in order to best plan a surgical reparative approach tailored to a single patient. PMID: 28544826 [PubMed - in process]
Source: Journal of Heart Valve Disease - Category: Cardiology Tags: J Heart Valve Dis Source Type: research
Conclusion: This case illustrates the value of F-18 FDG PET/CT in the diagnosis of and localization of a periaortic valve abscess in a patient with multiple valve replacements, recurrent fevers/sepsis and inconclusive imaging with transthoracic echocardiogram, transesophageal echocardiogram and Indium-111 WBC scan. The localization of the FDG activity to the posterior aspect of the valve which corresponded to the findings on transthoracic echocardiogram was key. Research Support:
Source: Journal of Nuclear Medicine - Category: Nuclear Medicine Authors: Tags: Educational Exhibits Posters Source Type: research
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