Endovascular Neurointervention in Cerebral Ischemia

Transcription

1 Endovascular Neurointervention in Cerebral Ischemia Beyond Thrombolytics Curtis A. Given II, MD Co-Director, Neurointerventional Services Baptist Physician Lexington

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3 72 y/o female with a recent diagnosis of paroxysmal atrial fibrillation developed right hemiparesis and global aphasia while at interstate rest stop. Patient was taken to regional medical facility (Corbin Baptist Regional) within 1 ½ hours of onset of symptoms. NIHSS was 16 and head CT was normal. IV-tPA was administered by the Emergency room physician and the patient was transferred to UK. Upon arrival to UK, the patient was hemiplegic with global aphasia and NIHSS was 22. Repeat head CT was normal. Patient was immediately taken to the Angiography suite

4 First pass with Merci retriever was performed at approximately 6 hours after the onset of symptoms

5 Two passes of the Merci retriever resultant in complete recanalization of the left middle cerebral artery

6 The patient began to have purposeful movement of her right arm and leg Immediately after the procedure. MRI of the head on the following day revealed only a few small infarcts. She was discharged home, independent and without the need for rehabilitation, and an NIHSS of 0.

7 Impact Stroke Every 45 seconds someone in the U.S. has a stroke Stroke is #3 cause of death Stroke is #1 cause of adult disability Approximately 87% ischemic Limited treatment options Intravenous lytic Limitation: must be administered within 3 hours of stroke onset Estimated <5% of stroke patients receive IV lytic Mechanical revascularization with Merci and Penumbra Retrieval Systems Option beyond 3 hour window, and for patients who are ineligible for or who fail IV t-pa therapy

8 Time Window for Potential Stroke Treatments Time Window hrs 0-6 hrs >6 hrs Options IV tpa Merci* Penumbra* Solitaire Merci Penumbra Solitaire IA Lytic Merci Penumbra Solitaire * 0-3 hours in patients who are contraindicated for IV tpa or who fail IV tpa therapy. Not FDA approved. The MERCI and Multi MERCI trials evaluated patients up to 8 hours

9 Patient Selection for Intra-arterial Therapy Generally patients with symptoms of large vessel occlusion (NIHSS > 8) No changes of large infarct (less than 1/3 of vascular territory) on CT or DWI No hemorrhage on CT < 8 hours since last seen normal OR significant tissue at-risk/penumbra on Perfusion imaging Any patient with basilar occlusion Large vessel occlusion on CTA/MRA

10 Contraindications to IA Thrombolysis CT-documented hemorrhage or significant mass effect Fibrinogen < 120 mg* Platelet count < 80,000* Active internal bleeding or recent surgery (<10 days)* Prior allergic reaction to r-tpa* BP > 200 systolic or >120 diastolic despite medical therapy No clot on angiography * Not contraindication to mechanical thrombectomy

11 What about patients presenting after 8 hours or wake up strokes? Significant problem, particularly in patients with an unknown time to onset ( wake up strokes). Traditionally, these patients offered only supportive measures 50% of patients may have a persistent ischemic penumbra at 24 hrs. Slide borrowed from Dr. Lev s ASNR presentation 2008

12 TTP > 6 sec rcbf 60% rcbv 110%

13 Trials of Intra-arterial Thrombolytic Agents PROACT II Furlan A. et al. JAMA 282:2003, 1999 Randomized open-label trial of prourokinase (r-pro-uk) 9 mg with heparin vs systemic heparin in patients with middle cerebral artery occlusions within 6 hours of onset. Pro-urokinase delivered over 2 hours by microcatheter into the middle cerebral artery at the face of the clot. Mechanical clot disruption was not permitted. Final angiogram at 2 hours in both groups.

14 Pre Interim Post 20 mg IA r-tpa

15 Endovascular Thrombectomy of Cerebral Vessels Merci Retriever First surgical device cleared by the FDA for acute ischemic stroke patients Restores blood flow to the brain by physically removing thrombus from the occluded precerebral or cerebral vessel

16 Candidates for Merci Therapy Only used for patients with ischemic stroke, not hemorrhagic stroke Patients who are ineligible for treatment with intravenous tpa : outside hour window other clinical factors, eg. recent surgery, long-term current use of anticoagulants for atrial fibrillation, allergy to t-pa Patients who have failed (or not responding to) prior intravenous t-pa therapy

17 Specialized Devices Merci Retriever Merci Microcatheter Merci Balloon Guide Catheter Endovascular thrombectomy devices were cleared by the FDA in August 2004

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24 Merci Registry Background The Merci Registry is a Post-Market study designed to capture real-world interventional treatment of acute stroke with the Merci Retriever system, unconstrained from the trial environment

25 Merci Registry The Largest, Prospective Multi-Center Study of Mechanical Embolectomy for AIS Prospective, multi-center study (36 centers) 1,000 patients enrolled in 3 years Interim results presented at ISC 2010 analyzed 625 patients Inclusion criteria: procedure must have included a Merci Retriever and patient informed consent No exclusion criteria Interim results validated MERCI and Multi MERCI results in a much larger unconstrained cohort

26 Revasc Rates by Final TICI Score Merci Registry Interim Analysis

27 Good Outcomes by Final TICI Score Merci Registry Interim Analysis Good Outcomes defined as mrs=0-2 at 90 days

28 Penumbra Thrombectomy System The Penumbra System is designed to revascularize large vessel occlusions in the intracranial circulation. The Penumbra System uses a unique microcatheter and Separator TM based thrombus debulking approach to intracranial vessel revascularization. The Penumbra advantages are: Proximal working position Continuous Aspiration Variable sizing for variable anatomy

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31 So What s Next? Stent-trievers Solitaire and Trevo Allow for faster and higher recanalization rates, with fewer device deployments ( passes ), and improved clinical outcomes relative to Merci Trevo Retrieve with Confidence

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33 Merci Retriever Clinical History The Solitaire FR device Retrospective data demonstrates higher angiographic and neurological outcomes when compared to these Merci registries. **TICI 2a-3 classification was used

34 Merci Competitive Messages: x improvement in Recanalization x improvement in neurological outcomes 3. 55% reduction in mortality

35 Solitaire FR revascularization device vs. The Concentric Merci Retriever 1 (SWIFT Study) (Core Lab)

36 79 yo WM awoke and walked to bathroom at 9am, wife heard loud noise and went to find husband lying in the floor of bathroom, aphasic and right sided hemiplegic. Transferred to CBH and received full-dose tpa at 12pm (approx. 3hrs after symptom onset). Initial NIHSS was 24 upon arrival to CBH. CT Perfusion scan shows large area of ischemia in left MCA territory consistent with large vessel occlusion, sent for possible thrombectomy.

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40 Partial flow restoration with Solitaire at 130pm (4.5 hrs after sx onset)

41 Two passes with 4x20mm Solitaire

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43 The next day, the patient had regained anti-gravity strength in the right upper and lower extremities and significant improvement in speech (mild-moderate residual expressive aphasia). 24 hr NIHSS had improved to 6 (initial was 24).

44 TTD rcbv 24 hr CT

45 TREVO 2 Thrombectomy REvascularization of large Vessel Occlusions in acute ischemic stroke Randomized, prospectively controlled, multi-center, noninferiority IDE study of arterial revascularization in acute ischemic stroke patients Up to 25 sites (at least 20 sites in North America) 1 st and only site in Kentucky 178 patients, with a planned interim analysis at 120 Randomized 1:1, with test arm using the Trevo device, the control arm using the Merci device

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50 27 yo male with history of eosinophilic myocarditis and dilated cardiomyopathy, presented with acute onset of left facial droop, left hemiplegia, dysarthria and gaze defect. Initial NIHSS=16. He was antiocoagulated for his cardiomyopathy and prior stroke (prior full recovery) with a PT/INR or 26.7/2.3 (therapeutic anticoagulation). Given anticoagulation, he was not a candidate for thrombolytic therapy (tpa). Was evaluated and treated my partner Christian Ramsey. TTD time-to-drain rcbv relative cerebral blood volume TTD time-to-drain rcbv relative cerebral blood volume TTD time-to-drain rcbv relative cerebral blood volume

51 TTD time-to-drain rcbv relative cerebral blood volume TTD time-to-drain rcbv relative cerebral blood volume TTD time-to-drain rcbv relative cerebral blood volume

52 4x20mm Solitaire

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54 The next day, the patient had regained full strength in the left upper and lower extremities and with only minimal residual facial droop. 24 hr NIHSS had improved to 1 (initial was 16).

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56 TTD time-to-drain 57 yo BF with wake up stroke manifesting as slurred speech and right arm/leg paralysis, resulting in fall to floor upon getting out of bed. PMH significant for non-ischemic cardiomyopathy with pacemaker (EF 30-35%), type II DM, and dyslipidemia (not on statin therapy). Initial NIHSS was 8 in the ED, and was NIHSS of 11 prior to procedure.

57 rcbv relative cerebral blood volume

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61 4 passes with the Solitaire and 6mg of IA tpa into the left MCA

62 TTD Initial CT Perfusion TTD F/u CT Perfusion 3 days later At the time of transfer to rehab, she regained full strength in her right lower extremity and her speech had significantly improved. Unfortunately she was still plegic in the right upper extremity.

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65 334 patients received endovascular therapy after IV t-pa administration (11 patients did not receive angiogram, 89 patients endovascular therapy was not administered). 142 patients received standard therapy consisting of additional IA t-pa 42.5% of patients in the endovascular arm received intra-arterial t-pa as MONO THERAPY. 22 patients - EKOS cath and t-pa 95 patients Merci (57 got additional IA t- PA) 54 patients Penumbra (38 got additional IA t-pa) 5 patients Solitaire (2 got additional IA t- PA) ONLY 1.5% of patients in the endovascular received most current treatment. 16 patients other (9 got additional IA t- PA) not specified as to what other is Endovascular Treatment 181 patients, 163 patients completed (18 excluded lack of occlusion, clinical improvement, etc.) Median time to treat 3.75 hrs 109 patients (67%) received intra-arterial t-pa as MONO THERAPY (0.9mg/kg given over 1hr, median dose 40mg) ONLY 56 patients (33%) received adjunctive mechanical thrombectomy 23 stent-treivers ONLY 14 % of the endovascular arm received current treatment 18 Solitaire 5 Trevo 5 Merci 9 Penumbra Remainder of devices not specified in the article.

66 In the 2 landmark trials assessing endovascular stroke therapy recently published Only 28 patients (5.4%) of the endovascular arm were treated with current technology (i.e. stent-trievers) 63% of patients receiving endovascular therapy received only IA tpa therapy (no mechanical thrombectomy of any method, i.e. no Merci, no Penumbra, no stent-triever) In my opinion, these trials were largely a revisit of the PROACT trials circa 1998.

67 CBH is one of sites that are conducting a prospective randomized trial comparing IV tpa versus IV tpa and Solitaire in the treatment of large vessel occlusions and acute stroke.

68 62 yo WF with history of CHF (20-25% EF), Cardiomyopathy, COPD, and recent ablation Normal state of health until 11pm, when she sustained a witnessed fall, with acute onset of aphasia and right sided hemiplegia 4/26/11 Presented to CBH ED and received IV tpa (bolus at 1:30 am, 2.5 hrs after sx onset) Initial NIHSS was 17

69 Right CCA Left CCA Only mild clinical improvement (NIHSS 15), brought to cath lab, initial angios at 2:30am

70 Left CCA Right CCA Left ICA with occluded left MCA Left VA

71 s/p aspiration thrombectomy with 9F Concentric Balloon catheter

72 Carotid Wallstent, effectively (luckily) trapped residual clot against ECA origin, protecting the CCA/ICA

73 Opening flow to ICA, allowed for tpa to reach intracranial circulation, and natural lysis of clot. No further intervention done.

74 4/27/11 She regained full strength in the right side of her body and had only expressive aphasia on 4/27/11. She began to recover speech on 4/28/11, and was left with only a mild aphasia

75 Be Proactive You do not have to wait for the stroke

76 Conclusion Evolving field with new technologies allowing us to extend the therapeutic window well beyond 3 hours Perfusion imaging will likely triage patient care in future Future (? current) standard of care likely to involve a combination of IV and Endovascular therapies