CRT 2011 Washington DC February 27 th March
CRT 2011 Washington DC, February 27 th – March 1 st Stroke in TAVI procedures: Will it limit its use to high risk patients? Cardiology View Eberhard Grube, MD, FACC, FSCAI University Hospital, Dept of Medicine II, Bonn, Germany Hospital Alemaõ Oswaldo Cruz, Saõ Paulo, Brazil Stanford University, School of Medicine, Palo Alto, CA
Disclosure Statement of Financial Interest Within the past 12 months, the presenter or their spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Physician Name Eberhard Grube, MD Company/Relationship Medtronic, Core. Valve: C, SB, AB, OF Sadra Medical: E, C, SB, AB Direct Flow: C, SB, AB Mitralign: AB, SB, E Boston Scientific: C, SB, AB Biosensors: E, SB, C, AB Cordis: AB Abbott Vascular: AB Capella: SB, C, AB Devax: SB, AB, Embrella, SB Claret, SB Key G – Grant and or Research Support E – Equity Interests S – Salary, AB – Advisory Board C – Consulting fees, Honoraria R – Royalty Income I – Intellectual Property Rights SB – Speaker’s Bureau O – Ownership OF – Other Financial Benefits‘
Aortic Atheroma: High Risk • 268 of 3404 CABG patients (8%) had atheroma (>/= 5 mm) defined by epi-aortic US 1 • 15. 3% of group had intra-operative stroke 1 1 Protruding aortic arch atheromas: risk of stroke during heart surgery with and without aortic arch endarterectomy. Stern et al. American Heart Journal Oct. 1999.
Stroke by Procedure Stroke Reference Rate Isolated CABG 1. 4 -3. 8% Review Article, Current Concepts of Perioperative Stroke, Selim N Engl J Med 2007: 356 -706 -13 PCI 0. 38% Stroke Complicating Percutaneous Coronary Interventions Incidence, Predictors, and Prognostic Implications Fuchs Circulation 2002; 106 Isolated Valve 4. 8 -8. 8% Review Article, Current Concepts of Perioperative Stroke, Selim N Engl J Med 2007: 356 -706 -13 Double Valve 9. 7% Review Article, Current Concepts of Perioperative Stroke, Selim N Engl J Med 2007: 356 -706 -13 CABG + Valve 7. 4% 4 Review Article, Current Concepts of Perioperative Stroke, Selim N Engl J Med 2007: 356 -706 -13
Perioperative Stroke by Type Study showed Most Strokes were Embolic – 62% www. nejm. org 706 February 15, 2007
84% “SILENT STROKE” following TAVI
Cerebral Ischemia After TAVI Kahlert PK et al. Circulation 2010; 121: 870 -878 New Lesions % Lesion Volume mm 3
30 -Day Stroke Rate 20% 15% 10% 9. 6% 4. 5% 5% 4. 0% 1. 9% 2. 6% 4. 0% 1. 7% 0% 18 Fr S&E 1* N = 125 ANZ 2 N = 118 French 3 N = 66 Belgian 4 N = 119 German 5 N = 588 UK 6 N = 460 Stroke is not defined consistently across all studies. Italian 7 N = 772 * Stroke is defined as permanent neurologic defects, included patients who had reversible neurologic events if there was structural evidence of an intracranial event. .
Clinical Outcomes at 30 Days & 1 Year 30 Days n=179 Outcome TAVI Death All (%) Cardiovascular (%) 1 Year n=179 Standard P-value Rx TAVI Standard P-value Rx Repeat hospitalization (%) 5. 0 4. 5 5. 6 2. 8 1. 7 10. 1 0. 41 0. 22 0. 17 30. 7 19. 6 22. 3 49. 7 41. 9 44. 1 0. 0004 <. 0001 Death (all) or repeat hosp (%) 10. 6 12. 3 0. 74 42. 5 70. 4 <. 0001 All (%) TIA (%) Minor stroke (%) Major stroke (%) 6. 7 0 1. 7 5. 0 1. 7 0 0. 6 1. 1 0. 03. 0. 62 0. 06 10. 6 2. 2 7. 8 4. 5 0 0. 6 3. 9 0. 04 1. 00 0. 37 0. 18 Death (all) or major stroke (%) 8. 4 3. 9 0. 12 33. 0 50. 3 0. 001 0 0 . 0. 6 1. 00 0 0 . Stroke or TIA Myocardial infarction All (%) Peri-procedural (%
Major VARC Endpoints • MORTALITY • MYOCARDIAL INFARCTION – All-cause and cardiovascular – Critical timepoints = 30 days and ≥ 1 year – Life table analytical analysis – Peri-procedural (< 72 hrs) and spontaneous – “Centrist” approach; higher thresholds; not solely biomarker dependent criteria – “clinically significant myocardial necrosis” • STROKE – TIA, minor stroke, and major stroke (clinically significant and – disabling); sub-classification based on etiology; neuro-imaging recommended Disability = Mod Rankin Score and neurologist adjudication
Cerebral Embolic Protection Device Goal – to improve the safety of the procedure Embrella Embolic Deflector Device Claret Dual Filter Deviceer
Average # of TCD HITS/Subject 841 379
Claret Summary • Carotid Filtration (embolic material captured and removed in all patients done (n=30) • Right Radial/Brachial Access • 6 F Sheath • 140 Micron Pore Size • 30 TAVI Clinical cases (Germany) • CE Mark approval target Q 1 2011
Embolic Material JIM Live Transmission February 2011
Embolic Material Emboli
FDA Stroke Definition • Any transient neurological deficit less than 24 hrs • associated with a structural deficit by imaging or Neurological Deficit for more than 24 hrs are considered to be a Stroke - • Minor – Major Stroke (assessed at 90 days) – – Minor = modified ranking 0 – 1 Major = modified ranking >1
Summary Stoke due to embolized plaques from the arch or the diseased native valve remains an issue with variable reported incidences (1. 4 -9. 3%) Event range in reported studies is partially due to differences in endpoint definitions which is now taken care of by the joint VARC efforts Various protection tools are currently in development with remarkable demonstration of usefulness and efficacy We have to learn more about embolic risk predictors, dividing patients in low risk and high risk, who are likely to benefit from protective tools. Until then. . .
Summary Given prior surgical and present TAVI experiences with new cerebral lesions occuring in up to 84% of cases (with or without neurological deficits), documented clinically or by imaging techniques…. and given the highly atheromatous environment within the aortic arch… TAVI procedures should be performed under cerebral protection in order to lower or even eliminate procedurally caused cerebral events
Thank you!
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