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Condition: Heart Valve Disease
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Total 330 results found since Jan 2013.
Edwards Lifesciences wins FDA nod for new Sapien 3 trial
Edwards Lifesciences (NYSE:EW) said today that the FDA approved a new trial of its Sapien 3 replacement heart valve.
The Sapien 3 transcatheter aortic valve replacement was approved last year by the federal safety watchdog for patients at high risk of death from open surgical procedures to replace their aortic valve. The new investigational device exemption for the Partner III trial is designed to evaluate the Sapien 3 TAVR in patients with a low mortality risk from open surgical valve replacement, the Irvine, Calif.-based company said.
“If this trial is successful, it will allow heart teams to choose a treatment ap...
Source: Mass Device - January 15, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Clinical Trials Food & Drug Administration (FDA) Regulatory/Compliance Replacement Heart Valves Edwards Lifesciences Source Type: news
Outcomes After Transcatheter Aortic Valve Replacement With Balloon-Expandable Versus Self-Expandable Valves CHOICE Trial Results
We read with interest the paper by Abdel-Wahab et al. (1) on 1-year outcomes of the CHOICE (Randomized Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: Medtronic CoreValve Versus Edwards SAPIEN XT Trial) randomized clinical trial comparing transcatheter aortic valve replacement (TAVR) with the balloon-expandable (BE) Edwards SAPIEN XT valve (Edwards Lifesciences, Irvine, California) versus self-expandable (SE) Medtronic CoreValve (Medtronic, Minneapolis, Minnesota). Of interest, the authors concluded that mortality was not statistically different between the 2 groups, but there w...
Source: Journal of the American College of Cardiology - January 12, 2016 Category: Cardiology Source Type: research
Transient ischemic attack during smoking: The thrombotic state of erythrocytes and platelets illustrated visually.
Abstract
Transient ischemic attack (TIA) is an important predictor of future ischemic events, including stroke. Due to the typically brief period of neurologic dysfunction, patients often overlook the importance of reporting a TIA. We have recently shown that platelet activation plays an important role in TIA pathology. In a similar vein, smoking is associated with a hypercoagulable state and is also one of the important risk factors for stroke. Here we present an interesting case where a 61-year-old male, with hypercholesterolemia, and a previous heart valve replacement, developed a TIA 5 months after he started ...
Source: Ultrastructural Pathology - December 21, 2015 Category: Pathology Authors: Bester J, van Rooy MJ, Mbotwe S, Duim W, Pretorius E Tags: Ultrastruct Pathol Source Type: research
At UCLA, it's medicine 2.0
Tucked deep in the basement of UCLA’s Center for the Health Sciences is a room that looks more like an inventor’s fantasy workshop than the medical research facility it is. Tables are piled high with tools, electronics, prototype equipment parts and a few stray robotic arms. Posters on the wall describe pending projects in dense technical language with accompanying photos of futuristic devices.
This hidden space is where scientists are working at the very forefront of technological advances in medicine. Its assemblage of smarts, parts and computers is contributing to an emerging era of personalized, tech-enabled health...
Source: UCLA Newsroom: Health Sciences - December 16, 2015 Category: Universities & Medical Training Source Type: news
Automatic extraction of forward stroke volume using dynamic PET/CT: a dual-tracer and dual-scanner validation in patients with heart valve disease
Background:
The aim of this study was to develop and validate an automated method for extracting forward stroke volume (FSV) using indicator dilution theory directly from dynamic positron emission tomography (PET) studies for two different tracers and scanners.
Methods:
35 subjects underwent a dynamic
11
C-acetate PET scan on a Siemens Biograph TruePoint-64 PET/CT (scanner I). In addition, 10 subjects underwent both dynamic
15
O-water PET and
11
C-acetate PET scans on a GE Discovery-ST PET/CT (scanner II). The left ventricular (LV)-aortic time-activity curve...
Source: Epidemiologic Perspectives and Innovations - October 26, 2015 Category: Epidemiology Authors: Hendrik HarmsLars TolbodNils HanssonTanja KeroLovisa OrndahlWon KimTomas BjernerKirsten BoucheloucheHenrik WiggersJørgen FrøkiærJens Sörensen Source Type: research
Medtech approvals: FDA releases August 2015 PMAs
The FDA today released its list of the pre-market approvals it granted for medical devices in August 2015:
Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 70
Summary of PMA Originals Under Review
Total Under Review: 57
Total Active: 28
Total On Hold: 29
Summary of PMA Supplements Under Review
Total Under Review: 569
Total Active: 422
Total On Hold: 147
Summary of All PMA Submissions
Originals: 5
Supplements: 90
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 70
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 229.0
FDA Time: 130...
Source: Mass Device - October 23, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Pre-Market Approval (PMA) Regulatory/Compliance Source Type: news
TCT 2015: Medtronic touts CoreValve TAVI real-world registry data
Update: Added data from study of new patient populations
Medtronic (NYSE:MDT) said today it released the 1st real-world registry study of its CoreValve transcatheter aortic valve implant, reporting outcomes in-line with its clinical trials of the device.
The medtech giant also released new data from 3 studies focusing on new patient populations with significant comorbidities today. Data from all of the CoreValve studies was presented at the annual Transcatheter Cardiovascular Therapeutics conference in San Franscisco.
The 6,160-patient Society of Thoracic Surgeons and American College of Cardiology TVT registry study repo...
Source: Mass Device - October 13, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Catheters Clinical Trials Medtronic TCT 2015 Source Type: news
Procedural Results and Clinical Outcomes of Transcatheter Aortic Valve Implantation in Switzerland: An Observational Cohort Study of Sapien 3 Versus Sapien XT Transcatheter Heart Valves Structural Heart Disease
Conclusions—
The use of the new generation S3 balloon-expandable THV reduced the risk of more than mild paravalvular regurgitation and vascular complications but was associated with an increased permanent pacemaker rate compared with the XT. Transcatheter aortic valve implantation using the newest generation balloon-expandable THV is associated with a low risk of stroke and favorable clinical outcomes.
Clinical Trial Registration—
URL: http://www.clinicaltrials.gov. Unique identifier: NCT01368250.
Source: Circulation: Cardiovascular Interventions - October 9, 2015 Category: Cardiology Authors: Binder, R. K., Stortecky, S., Heg, D., Tueller, D., Jeger, R., Toggweiler, S., Pedrazzini, G., Amann, F. W., Ferrari, E., Noble, S., Nietlispach, F., Maisano, F., Raber, L., Roffi, M., Grunenfelder, J., Juni, P., Huber, C., Windecker, S., Wenaweser, P. Tags: Catheter-based coronary and valvular interventions: other, CV surgery: valvular disease Structural Heart Disease Source Type: research
Stroke prevention in valvular heart disease: from the procedure to long-term management.
Authors: Giustino G, Dangas GD
Abstract
Stroke in patients with valvular heart disease undergoing transcatheter intervention is relatively rare but associated with significant morbidity and mortality. Risks vary according to the underlying valve disease and proposed procedure. While major improvements have been made in developing and understanding the technical factors associated with intra- and peri-procedural stroke, uncertainty exists regarding the optimal antithrombotic management strategy after transcatheter heart valve intervention and the utility of routine cerebral embolic protection. Further clinical studi...
Source: EuroIntervention - September 20, 2015 Category: Cardiovascular & Thoracic Surgery Tags: EuroIntervention Source Type: research
Glomerular filtration rate and association to stroke, major bleeding, and death in patients with mechanical heart valve prosthesis
Conclusion In patients with MHV on anticoagulation, eGFR is an independent predictor of major bleeding and death and not TE.
Source: American Heart Journal - September 15, 2015 Category: Cardiology Source Type: research
Dabigatran is Less Effective Than Warfarin at Attenuating Mechanical Heart Valve-Induced Thrombin Generation Valvular Heart Disease
Conclusions
MHV induce thrombin generation via the intrinsic pathway and generate sufficient thrombin to overwhelm clinically relevant dabigatran concentrations. In contrast, warfarin is more effective than dabigatran at suppressing MHV-induced thrombin generation. These data explain why dabigatran failed in MHV patients and suggest that strategies targeting FXII or FXI may suppress the root cause of thrombosis in such patients.
Source: JAHA:Journal of the American Heart Association - August 24, 2015 Category: Cardiology Authors: Jaffer, I. H., Stafford, A. R., Fredenburgh, J. C., Whitlock, R. P., Chan, N. C., Weitz, J. I. Tags: Valvular Heart Disease Source Type: research
Preoperative statin therapy for patients undergoing cardiac surgery.
CONCLUSIONS: Preoperative statin therapy reduces the odds of postoperative atrial fibrillation (AF) and shortens the patient's stay on the ICU and in the hospital. Statin pretreatment had no influence on perioperative mortality, stroke, myocardial infarction or renal failure, but only two of all included studies assessed mortality. As analysed studies included mainly individuals undergoing myocardial revascularisation, results cannot be extrapolated to patients undergoing other cardiac procedures such as heart valve or aortic surgery.
PMID: 26270008 [PubMed - as supplied by publisher]
Source: Cochrane Database of Systematic Reviews - August 13, 2015 Category: Journals (General) Authors: Kuhn EW, Slottosch I, Wahlers T, Liakopoulos OJ Tags: Cochrane Database Syst Rev Source Type: research
Study: Edwards’ Sapien and Medtronic’s CoreValve outcomes are similar
A new study published in the Journal of the American College of Cardiology found that patients treated with Edwards Lifesciences‘s (NYSE:EW) and Medtronic‘s (NYSE:MDT) CoreValve showed similar results after 1 year.
The 241-patient trial examined high-risk patients with symptomatic severe aortic stenosis 1 year after being treated with either Edwards’s Sapien balloon expanding or Medtronic’ self-expanding transcatheter heart valve.
The rates of all-cause death and cardiovascular death were not statistically different between the groups, with a 3-5% difference between the 2 devices, according to the ...
Source: Mass Device - August 11, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Edwards Lifesciences medtronic Source Type: news
TAVI: Study finds low stroke rates with Medtronic’s CoreValve
A clinical study of nearly 1,000 patients implanted with Medtronic‘s (NYSE:MDT) CoreValve replacement heart valve found a low rate of stroke out to 2 years.
The study, published last month in the Journal of the American College of Cardiology, evaluated patients for neurological events over 3 periods after the procedure to implant the CoreValve transcatheter aortic valve implant: Periprocedural (0 to 1 days); early (2 to 30 days); and late (31 to 730 days).
Results from the 996-patient trial, “The Incidence and Predictors of Early- and Mid-Term Clinically Relevant Neurological Events After Transcatheter Aortic ...
Source: Mass Device - August 3, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Clinical Trials Regulatory/Compliance CoreValve Inc. medtronic Source Type: news
Clinical Value of Ankle-Brachial Index in Asymptomatic Aortic Stenosis Patients.
CONCLUSION: Among asymptomatic AS patients, 35.8% had an abnormal ABI and this was related to previous diabetes. These patients walked less in the 6MWT but did not have a worse prognosis at follow up.
PMID: 26204678 [PubMed - in process]
Source: Journal of Heart Valve Disease - July 25, 2015 Category: Cardiology Tags: J Heart Valve Dis Source Type: research
