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Lansky A.J.,Yale University | Lansky A.J.,Yale Cardiovascular Research Group | Lansky A.J.,Queen Mary, University of London | Messe S.R.,University of Pennsylvania | And 37 more authors.
Journal of the American College of Cardiology | Year: 2017

Surgical and catheter-based cardiovascular procedures and adjunctive pharmacology have an inherent risk of neurological complications. The current diversity of neurological endpoint definitions and ascertainment methods in clinical trials has led to uncertainties in the neurological risk attributable to cardiovascular procedures and inconsistent evaluation of therapies intended to prevent or mitigate neurological injury. Benefit-risk assessment of such procedures should be on the basis of an evaluation of well-defined neurological outcomes that are ascertained with consistent methods and capture the full spectrum of neurovascular injury and its clinical effect. The Neurologic Academic Research Consortium is an international collaboration intended to establish consensus on the definition, classification, and assessment of neurological endpoints applicable to clinical trials of a broad range of cardiovascular interventions. Systematic application of the proposed definitions and assessments will improve our ability to evaluate the risks of cardiovascular procedures and the safety and effectiveness of preventive therapies. © 2017 The Authors


Baumbach A.,Royal Infirmary | Pietras C.,Yale Cardiovascular Research Group | Lansky A.,Yale Cardiovascular Research Group
Expert Review of Medical Devices | Year: 2015

The incidence of embolic ischemic cerebral events during transcatheter aortic valve implantation remains high. The effects range from clinically silent embolic lesions in the brain to severe disabling stroke. Memory loss and other functional neurocognitive impairment are a direct result of embolic strokes. The TriGuard embolic deflection device is a nitinol frame filter that is placed across all three aortic cerebral vessel ostia to prevent particles from entering the brain circulation during the procedure. The results of clinical studies suggest that this procedure can lead to a reduction of embolic events, and an improvement of neurocognitive function when compared with unprotected transcatheter aortic valve implantation. © 2015 © 2015 Taylor & Francis.


Lansky A.J.,Yale University | Lansky A.J.,Yale Cardiovascular Research Group | Schofer J.,University of Hamburg | Tchetche D.,Clinique Pasteur | And 22 more authors.
European Heart Journal | Year: 2015

Aims To evaluate the safety, efficacy, and performance of the TriGuard™ HDH Embolic Deflection Device (TriGuard) compared with no cerebral protection in patients undergoing transcatheter aortic valve implantation (TAVI). Methods and results From February 2014 to March 2015, 85 subjects undergoing TAVI at 13 centres in Europe and Israel were randomized to TriGuard protection vs. no protection. Subjects underwent neurologic and cognitive evaluation at baseline, pre-discharge and 30 days; cerebral diffusion-weighted magnetic resonance imaging was performed at 4 ± 2 days post-procedure and at 30 days. Technical success, which included complete 3-vessel cerebral coverage, was achieved in 88.9% (40/45) of cases. The primary in-hospital procedural safety endpoint (death, stroke, life-threatening or disabling bleeding, stage 2 or 3 acute kidney injury, or major vascular complications) occurred in 21.7% of TriGuard and 30.8% of control subjects (P = 0.34). In the Per Treatment population (subjects with complete three-vessel cerebral coverage), TriGuard use was associated with greater freedom from new ischaemic brain lesions (26.9 vs. 11.5%), fewer new neurologic deficits detected by the National Institutes of Health Stroke Scale (3.1 vs. 15.4%), improved Montreal Cognitive Assessment (MoCA) scores, better performance on a delayed memory task (P = 0.028) at discharge, and a >2-fold increase in recovery of normal cognitive function (MoCA score >26) at 30 days. Conclusion TriGuard cerebral protection during TAVI is safe and complete cerebral vessel coverage was achieved in 89% of subjects. In this exploratory study, subjects undergoing protected TAVI had more freedom from ischaemic brain lesions, fewer neurologic deficits, and improved cognitive function in some domains at discharge and 30 days compared with controls. © 2015 The Author.


PubMed | Baptist Hospital of Miami, St Francis Hospital, Yale University, The Heart Hospital and 4 more.
Type: Journal Article | Journal: The American journal of cardiology | Year: 2016

Cerebral embolization during transcatheter aortic valve implantation (TAVI) can lead to a spectrum of clinically relevant manifestations, ranging from overt stroke to mild neurologic or cognitive deficits and subclinical cerebral infarcts. This study sought to determine the frequency of neurologic injury, cerebral ischemic lesions, and cognitive dysfunction in subjects undergoing contemporary commercial TAVI in the United States. Neuro-TAVR is the first prospective, multicenter study to use serial systematic neurologic and cognitive assessments and diffusion-weighted magnetic resonance imaging (at 4 2days after procedure) to investigate the incidence and severity of neurologic injury after contemporary unprotected TAVI in the United States. A total of 44 consecutive patients underwent TAVI at 5 US sites. Diffusion-weighted magnetic resonance imaging lesions were detected in 94%, with a mean of 10.4 15.3 lesions per subject and a median total lesion volume of 295mm


Nolan J.P.,Royal United Hospital | Lyon R.M.,London Air Ambulance | Sasson C.,Aurora University | Rossetti A.O.,University of Lausanne | And 3 more authors.
Heart | Year: 2012

The outcome for patients after an out-of-hospital cardiac arrest (OHCA) has been poor over many decades and single interventions have mostly resulted in disappointing results. More recently, some regions have observed better outcomes after redesigning their cardiac arrest pathways. Optimised resuscitation and prehospital care is absolutely key, but in-hospital care appears to be at least as important. OHCA treatment requires a multidisciplinary approach, comparable to trauma care; the development of cardiac arrest pathways and cardiac arrest centres may dramatically improve patient care and outcomes. Besides emergency medicine physicians, intensivists and neurologists, cardiologists are playing an increasingly crucial role in the post-resuscitation management, especially by optimising cardiac output and undertaking urgent coronary angiography/ intervention.

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