Embolic Protection Devices in Transcatheter Aortic Valve Replacement: Are We Barking Up the Wrong Vascular Tree? Circulation: cardiovascular intervention.

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Presentation transcript:

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 TAVR Embolic protection devices Pitfalls of current research The purpose of this manuscript was to provide an overview of the updated ongoing clinical research on embolic protection devices and present its major caveats.

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 21st 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 21st 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 21st Century.

Stroke in TAVR Silent CNS infarction in TAVR This is nice review we have found showing that since the more frequent use of DW MRI higher rates of post procedural silent infarctions have been found.

Stroke in TAVR % % Partner cohort B Partner cohort A 30 d Stroke or TIA

Updated 30-d all neuro events rates 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

Multiple, small, widespread, clinically silent Stroke in TAVR Multiple, small, widespread, clinically silent

PPT overview Stroke in TAVR TAVR Embolic protection devices Pitfalls of current research The purpose of this manuscript was to provide an overview of the updated ongoing clinical research on embolic protection devices and present its major caveats.

Trans catheter EPD Deflector Filter Device Embrella TriGuard Sentinel Manufacturer Design Access Delivery Deployment Embrella Edwards Lifesciences, Irvine, CA, USA Deflector Radial/ brachial 6 Fr Aortic arch TriGuard Keystone Heart Ltd, Caesarea, Israel Femoral 9 Fr Sentinel Claret Medical Inc., Santa Rosa, CA, USA Filter Two filters to brachiocephalic trunk and left common carotid

Embolic protection devices Embrela However since than newer data has shown much lower rates of stroke in TAVR Show a slide of the newer articles and Corvalve Mechanism of stroke withtavr – show slide

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 No baseline MRI because because the researchers assumed a high baseline rate of silent ischemia …. European Heart Journal 2015

Embolic protection devices Triguard No baseline MRI because because the researchers assumed a high baseline rate of silent ischemia ….

Embolic protection devices Triguard No baseline MRI because because the researchers assumed a high baseline rate of silent ischemia …. European Heart Journal 2015

Embolic protection devices Triguard Safety No baseline MRI because because the researchers assumed a high baseline rate of silent ischemia …. European Heart Journal 2015

Embolic protection devices Triguard efficacy Reduction in lesion number Reduction in lesion volume No statistical significance* TriGuard use was associated with greater freedom from new ischaemic brain lesions (26.9 vs. 11.5%), European Heart Journal 2015

Embolic protection devices Triguard cognitive Lower NIHSS score on discharge Improved Montreal Cognitive Assessment (MoCA) scores. Better performance on a delayed memory task at discharge. NIH stroke scale Montreal Cognitive Assessment score 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 (P¼0.028) at discharge, and a .2-fold increase in recovery of normal cognitive function (MoCAscore .26) at 30 days. European Heart Journal 2015

Embolic protection devices Triguard No baseline MRI because because the researchers assumed a high baseline rate of silent ischemia ….

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 Sentinel trial

Embolic protection devices Claret device/Sentinel Sentinel trial

Embolic protection devices Claret device/Sentinel Sentinel trial

PPT overview Stroke in TAVR TAVR Embolic protection devices Pitfalls of current research The purpose of this manuscript was to provide an overview of the updated ongoing clinical research on embolic protection devices and present its major caveats.

Pitfalls of current research Brain infarct, stroke, and silent stroke Use of DW MRI Neuro-cognitive testing Cardiac surgery perspective However since than newer data has shown much lower rates of stroke in TAVR Show a slide of the newer articles and Corvalve Mechanism of stroke withtavr – show slide

Pitfalls of current research Brain infarct, stroke, and silent stroke Clinical manifestations of embolism depend on: Number Volume Type Location Cerebral tissue condition Temporal profile of the particle shower CNS infarct ≠ Clinical stroke CNS infarct ≠ Clinical stroke Just the presence of particulate debris in brain matter may not correlate with the extent of brain injury or clinical function as a slower rate of particle release may have less potential for ischemic injury than the same number of particles delivered in a sudden shower, and given an identical embolic insult, cerebral tissue with reduced perfusion pressure has a greater risk of permanent ischemic injury than cerebral tissue with normal perfusion pressure 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 45 TAVI patients at baseline 17 at 6 months J Cardiovasc Magn Reson. 2013; 15(Suppl 1): O59.

Pitfalls of current research Use of DW MRI Switch from 1.5T to 3T 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 Neuro-cognitive testing ‘ Cognitive function in 111 TAVR 0 3D 3M 1Y 2Y Overall Cognition intact for > 90% for 2y 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 21 SAVR patients at baseline 18 at 6 months J Cardiovasc Magn Reson. 2013; 15(Suppl 1): O59.

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