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Technology Overview and Perspective from DEFLECT III

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Presentation on theme: "Technology Overview and Perspective from DEFLECT III"— Presentation transcript:

1 Technology Overview and Perspective from DEFLECT III
Alexandra Lansky, MD Professor of Medicine, Section of Cardiology Yale School of Medicine

2 Disclosure Statement of Financial Interest
Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship Company Grant/Research Support Consulting Fees/Honoraria Major Stock Shareholder/Equity Royalty Income Ownership/Founder Intellectual Property Rights Other Financial Benefit KeyStone Heart Company Names

3 Stroke Underreported in AVR Studies
In reported clinical trials disabling stroke rates with TAVR range from 1.6%-5.9% Stroke rate is 15-27% after TAVR by current AHA/ASA definitions Neurologist identified deficits with new brain MRI lesions 1Van Mieghem NM, EuroIntervention. 2016;12:499. 2Messe S, Circulation. 2014;129: Lansky AJ, Eur Heart J. 2015; 36:2070. 4Lansky AJ, PCR London Vlaves 2015, AJC 2016 (in press). 5Haussig S, JAMA. 2016;316:592. 3

4 US NeuroTAVR Trial: Outcome
Neurologic and Cognitive Impairment % of patients with worsening MRS, NIHSS and MoCA + new brain lesions Stroke defined by AHA/ASA stroke definitions are common: Discharge: 22.6% 30-Days: 14.8% MoCA scores (surrogate of Cognition) get worse in 40% of patients after TAVR: More than 40% of patients have worse cognition at 30 days after TAVR based on MoCA and a broad range of other validated cognitive tests Lansky et al AJC (2016), 4

5 TriGuard: Cerebral Embolic Protection
• Highly flexible nitinol frame and mesh • Low profile • Reduced mesh pore size (130µ X 250µ) improves efficacy without compromising hemodynamics • Easily maneuverable • 4 marker bands on frame for visibility • Designed to cover ALL major cerebral vessels entire cerebro-vascular system: innominate, left carotid, and subclavian • Over the arch delivery vs down the carotids designed to minimize brain emboli 5

6 Equal distribution of cerebral embolization to all cerebral vessels
validates the need for complete 3 vessel protection Potential Paths of Cerebral Embolism Distribution of Embolic Cerebral Damage by DWI 33.0% 27.0% 38.0% Vertigo, falling to left Diplopia, dysarthria Hemiparesis or quadriparesis Hemisensory loss Hemianopia or cortical blindness Layton KF et al. Bovine Aortic Arch Variant in Humans. AJNR 2006. Arnold et al. Embolic Cerebral Insults After TAVI Detected by MRI. JACC 2010. 6

7 Intent To Treat Population Embolic Protection (TriGuardTM)
DEFLECT III Trial Intent To Treat Population N=83 Embolic Protection (TriGuardTM) n = 45 Unprotected TAVR (Control) n = 38 In-hospital FU Safety n = 45 DW-MRI: n = 32 (ITT), n = 26 (PT) Safety n = 38 n = 25 (ITT), n = 25 (PT) Deployment Success: 93.5% Successful positioning: 87%(complete 3-vessel coverage until final valve deployment of first valve, verified by QCA) Safety at 30 days (death, stroke, life threatening bleed, AKI, major vascular Complications) 26% TG vs 31% control Lansky AJ, Eur Heart J. 2015; 36:2070. 7

8 DW-MRI Results – Patients with no Ischemic Brain Lesions
Protection increases freedom from ischemic lesions 42% 55% 8

9 Clinical Efficacy Outcomes – Stroke and Cognition
Protection reduces worsening of neurologic and cognitive outcomes Patients with worsening NIHSS and MoCA with MRI brain injury from baseline to discharge ASA/AHA Stroke Cognition (MoCA) Worse 9

10 Embolic Protection with TAVR
Patients who underwent TAVR without embolic protection demonstrated reductions in cognitive function (MoCA Score) and memory, while patients undergoing TAVR with the TriGuard device demonstrated improved scores on cognition and memory testing.1 At 30 days >2 fold recovery in cognition with protection: Age Normalized MoCA Score: 45% TG vs 20% of controls RR %CI [ ] 1Lansky AJ, Eur Heart J. 2015;36:2070.

11 Pooled Analysis of Keystone Heart Clinical Trials
OBJECTIVES: To evaluate the safety and efficacy of the TriGuard device as an adjunct to TAVI compared to no protection in an expanded patient level pooled analysis of 3 prospective clinical trials METHODS: A total of 142 patients (TriGuard N=59 vs Controls N=83). This per-treatment analysis includes all TG patients with adjudicated complete cerebral coverage Trials included: DEFLECT I, DEFLECT III and NeuroTAVR ENDPOINTS: • MACCE: all death, stroke, bleeding, AKI, Vasc Complications • Stroke: VARC2 defined * and AHA/ASA defined:** • CNS infarction: Number an Volume New MRI lesions • Worsening NIHSS and cognitive function (MoCA) *AP Kappetein et al. EHJ (2012) 33, 2403–2418; **Sacco et al. Stroke. 2013;44: 11

12 TriGuard Pooled Analysis: In Hospital Results
Primary Safety Endpoint of 30 day MACCE: 18.2% TG vs 24.1% Control, p=0.44 Efficacy Measures, % Lansky et al PCR 2016 12

13 REFLECT US IDE Trial Design
Roll-In N≤90 Subject with AS undergoing TAVI N=285 2:1 Randomization TriGuard Embolic Protection n=190 Unprotected TAVI n=95 :07:24 PM MA 31 4 4 MA :07:24 PM 31 SAFETY • Combined safety endpoint (VARC-2) at 30 days • TriGuard vs. Performance Goal EFFICACY • Hierarchical composite efficacy endpoint (Finkelstein-Schoenfeld): - Death or stroke (30 d) - NIHSS (in-hospital) or MoCA worsening (30 days) - Total lesion volume by DW-MRI (post-procedure) • TriGuard vs. Control Co-PI: Lansky A, Moses J, Baumbach A, Makkar R 13

14 NeuroARC Definitions and Classification
Type 1: Overt CNS Injury (Acutely Symptomatic) Type 1a Ischemic Stroke Focal or multi-focal vascular territory Symptoms ≥24 hours or until death or Symptoms <24 hours with neuroimaging confirmation Subtype 1aH: Ischemic Stroke with Hemorrhagic conversion Class A: Petechial Hemorrhage Class B: Confluent Hemorrhage (with space occupying effect) Type 1.b Intracerebral Hemorrhage Symptoms (focal or global) caused by an intraparenchymal or intraventricular bleed Type 1.c Subarachnoid Hemorrage Symptoms (focal or global) caused by a subarachnoid bleed Type 1.d Stroke, not otherwise specified Symptoms ≥24 hours or until death, without imaging Type 1.e Hypoxic-Ischemic Injury Global neurologic symptoms due to diffuse brain injury attributable to hypotension and/or hypoxia NeuroARC Definitions and Classification Relevant to Patients, Comprehensive, Practical Type 2: Covert CNS Injury (Acutely Asymptomatic brain injury detected by NeuroImaging) Type 2.a Covert CNS Infarction Acutely asymptomatic focal or multi-focal ischemia, based on neuroimaging Subtype 2aH: Ischemic Stroke with Hemorrhagic conversion Class A: Petechial Hemorrhage Class B: Confluent Hemorrhage (with space occupying effect) Type 2.b Covert Cerebral Hemorrhage Neuroimaging or Acutely asymptomatic CNS hemorrhage on neuroimaging that is not caused by trauma Type 3: Neurologic Dysfunction without CNS Injury (Acutely Symptomatic) Type 3.a Transient Ischemic Attack (TIA) Symptoms <24 hours with no evidence of acute infarction by neuroimaging Type 3.b Delirium without CNS injury Transient non-focal (global) neurologic signs or symptoms (variable duration) without evidence of cell death by pathology or neuroimaging 14

15 Conclusions Stroke and neurocognitive decline are a significant complication of TAVR TriGuard during TAVR is safe and provided complete cerebral coverage in 87% of cases Cerebral protection with TriGuard reduces stroke risk, unintended cerebral injury and measures of cognition The ongoing REFLECT Trial is designed to demonstrated safety and efficacy and will be complete in Q3 2017 15

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