Embolic Protection Devices in Transcatheter Aortic Valve Replacement
Embolic Protection Devices in Transcatheter Aortic Valve Replacement: Are We Barking Up the Wrong Vascular Tree? Circulation: cardiovascular intervention 2016 Arie Steinvil, Richard T. Benson, Ron Waksman
PPT overview Stroke in TAVR Embolic protection devices Pitfalls of current research
Stroke in TAVR Mechanism of embolic stroke during TAVR • Balloon dilatation in a severely calcified valve • Passage of devices at aortic arch • Catheter debri • Carotid disease • Thrombi JACC Cardiovasc Interv. 2015; 8: 718 -724
Stroke in TAVR How is stroke defined in TAVR trials? How common is clinical stroke in TAVR? How common is silent CNS infarction?
Stroke in TAVR New definition of stroke Stroke. 2013; 44: 2064 -2089. AHA/ASA : An Updated Definition of Stroke for the 21 st Century.
Stroke in TAVR Silent CNS infarction Silent infarcts are well recognized to be associated with several adverse neurological and cognitive consequences: Impaired mobility, Physical decline, Depression, Cognitive dysfunction, Dementia Parkinson’s disease, Alzheimer disease Stroke. 2013; 44: 2064 -2089. AHA/ASA An Updated Definition of Stroke for the 21 st Century. .
Stroke in TAVR Silent CNS infarction Figure of brain and rates Fingerprints statement Stroke. 2013; 44: 2064 -2089. An Updated Definition of Stroke for the 21 st Century.
Stroke in TAVR Silent CNS infarction in TAVR
Stroke in TAVR Partner cohort B Partner cohort A P=0. 03 P=0. 04 % % 30 d Stroke or TIA
Stroke in TAVR Updated 30 -d all neuro events rates
Stroke in TAVR New Silent CNS infarction following TAVR % Clinical stroke: 0/32 2/31 2/60
Stroke in TAVR Multiple, small, widespread, clinically silent
PPT overview Stroke in TAVR Embolic protection devices Pitfalls of current research
Trans catheter EPD Device Manufacturer Embrella Edwards Lifesciences, Irvine, CA, USA Tri. Guard Keystone Heart Ltd, Caesarea, Israel Sentinel Claret Medical Inc. , Santa Rosa, CA, USA Design Deflector Filter Access Delivery Deployment Radial/ 6 Fr Aortic arch Femoral 9 Fr Aortic arch Radial/ 6 Fr Two filters to brachiocephalic trunk brachial and left common carotid
Embolic protection devices Embrela
Embolic protection devices Embrela PROTAVI-C pilot study J Am Coll Cardiol Intv 2014; 7: 1146– 55.
Embolic protection devices Embrela PROTAVI-C pilot study J Am Coll Cardiol Intv 2014; 7: 1146– 55.
Embolic protection devices Triguard
Embolic protection devices Triguard
Embolic protection devices Triguard European Heart Journal 2015
Embolic protection devices Triguard
Embolic protection devices Triguard European Heart Journal 2015
Embolic protection devices Triguard Safety European Heart Journal 2015
Embolic protection devices Triguard efficacy Reduction in lesion number Reduction in lesion volume No statistical significance* European Heart Journal 2015
Embolic protection devices Triguard cognitive Lower NIHSS score on discharge Improved Montreal Cognitive Assessment (Mo. CA) scores. Better performance on a delayed memory task at discharge. European Heart Journal 2015
Embolic protection devices Triguard
Embolic protection devices Claret device/Sentienl Clean TAVI Sentinel
Embolic protection devices Claret device/Sentinel Clean TAVI trial
Embolic protection devices Claret device/Sentinel Clean TAVI trial
Embolic protection devices Claret device/Sentinel Clean TAVI trial
Embolic protection devices Claret device/Sentinel Clean TAVI trial
Embolic protection devices Claret device/Sentinel trial
Embolic protection devices Claret device/Sentinel trial
Embolic protection devices Claret device/Sentinel trial
PPT overview Stroke in TAVR Embolic protection devices Pitfalls of current research
Pitfalls of current research • Brain infarct, stroke, and silent stroke • Use of DW MRI • Neuro-cognitive testing • Cardiac surgery perspective
Pitfalls of current research Brain infarct, stroke, and silent stroke Clinical manifestations of embolism depend on: Number C NS Volume infa Type rct ≠ Clin Location i cal Cerebral tissue condition stro ke Temporal profile of the particle shower Derdeyn CP. Diffusion-weighted imaging as a surrogate marker for stroke as a complication of cerebrovascular procedures and devices. AJNR Am J Neuroradiol. 2001; 22: 1234 -1235.
Pitfalls of current research Brain infarct, stroke, and silent stroke • EPD trial define surrogate markers of the disease as the primary outcome • Not recommended by the AHA/ASA guidelines
Pitfalls of current research Brain infarct, stroke, and silent stroke • EPD trial do not use updated stroke definitons which include silent CNS ischemia
Pitfalls of current research Use of DW MRI Lack of long term DW MRI follow up The number of CNS lesions: • Increase following TAVR • Reduce with time J Cardiovasc Magn Reson. 2013; 15(Suppl 1): O 59. 45 TAVI patients at baseline 17 at 6 months
Pitfalls of current research Use of DW MRI Switch from 1. 5 T to 3 T • Inability to compare to historic cohorts • Enhanced sensitivity might cause over estimation of lesions otherwise ignored in real world setting • No standardization
Pitfalls of current research Neuro-cognitive testing ‘Neurocognitive assessment battery’ • • Interobserver variability No standardization No long term follow up in trials Current TAVR patients have other reasons for cognitive decline
Pitfalls of current research Cognitive function in 111 TAVR Neuro-cognitive testing ‘ 0 3 D 3 M 1 Y 2 Y Overall Cognition intact for > 90% for 2 y after TAVR Circ interventions 2013. Cognitive Trajectory After Transcatheter Aortic Valve Implantation
Pitfalls of current research Cardiac surgery perspective
Pitfalls of current research Cardiac surgery perspective This road has been taken… No EPD used EPD trials EPD devices New post op CNS lesions on MRI
Pitfalls of current research Cardiac surgery perspective Similar to TAVR The number of CNS lesions: Increase following SAVR Reduce with time J Cardiovasc Magn Reson. 2013; 15(Suppl 1): O 59. 21 SAVR patients at baseline 18 at 6 months
Pitfalls of current research Cardiac surgery perspective Similar to TAVR • MRI Lesions were multiple, small, widespread • Weakness in the reproducibility and objectivity of neurocognitive testing • Various protection devices tested without benefit
Summary Silent stroke in TAVR is common Stroke is not The clinical significance of silent stroke In TAVR is unknown
Summary EPD may reduce silent CNS infarcts EPD may reduce cognitive decline EPD Trials investigate surrogate markers, not yet proven to cause harm
Thank you What is the true significance of new post TAVR CNS lesions? No EPD used EPD trials EPD devices New post op CNS lesions on MRI
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