Mechanical Thrombectomy: Where Are We Now? T. Adam Oliver, MD Tallahassee Neurological Clinic Tallahassee, Florida TMH Neurosymposium June 11, 2016

Transcription

1 Mechanical Thrombectomy: Where Are We Now? T. Adam Oliver, MD Tallahassee Neurological Clinic Tallahassee, Florida TMH Neurosymposium June 11, 2016

2 none DISCLOSURES

3 Where did we come from?

4 Spiotta, et al. JNIS 2014

5 Devices we started with Microcatheter and wire Microcatheter and IA tpa Balloons Alligator Snare

6 STROKE EVOLUTION

7 Penumbra Seperators STROKE EVOLUTION

8 Penumbra STROKE EVOLUTION Stent Retriever 1

9 Penumbra STROKE EVOLUTION Stent Retriever 1 Stent Retriever w/ Direct Aspiration SOLUMBRA

10 STROKE EVOLUTION

11 Stroke Therapy Evolution Trial Merci Penumbra SWIFT 2012 TREVO 2012 NASA NASA Balloon Guide Solumbra Humphri es, et al jnis 2014 STAR ADAPT FAST Patients /58 / Time Window 8 hours 8 hours 8 hours 8 hours 8 hours 8 hours None 8 hours None sich % % 1.7% 7% 9.9% 12.2% 5% 1.5% 0 Mortality 90 days 31-44% 22-45% 18% 34% 30% 26% 29% 6.9% 20% mrs 2 90 days 28-35% 25-40% 37% 40% 42% 52% 44% 58% 40% TICI 2a % % 83% site 86.4% 87.5% 88% TICI 2b % 68% Core lab 72.5% 76% 88% 85% 95%

12 Stroke Therapy Evolution Trial Merci Penumbra SWIFT 2012 TREVO 2012 NASA NASA Balloon Guide Solumbra Humphri es, et al jnis 2014 STAR ADAPT FAST Patients /58 / Time Window 8 hours 8 hours 8 hours 8 hours 8 hours 8 hours None 8 hours None sich % % 1.7% 7% 9.9% 12.2% 5% 1.5% 0 Mortality 90 days 31-44% 22-45% 18% 34% 30% 26% 29% 6.9% 20% mrs 2 90 days 28-35% 25-40% 37% 40% 42% 52% 44% 58% 40% TICI 2a % % 83% site 86.4% 87.5% 88% TICI 2b % 68% Core lab 72.5% 76% 88% 85% 95%

13 Stroke Therapy Evolution Trial Merci Penumbra SWIFT 2012 TREVO 2012 NASA NASA Balloon Guide Solumbra Humphri es, et al jnis 2014 STAR ADAPT FAST Patients /58 / Time Window 8 hours 8 hours 8 hours 8 hours 8 hours 8 hours None 8 hours None sich % % 1.7% 7% 9.9% 12.2% 5% 1.5% 0 Mortality 90 days 31-44% 22-45% 18% 34% 30% 26% 29% 6.9% 20% mrs 2 90 days 28-35% 25-40% 37% 40% 42% 52% 44% 58% 40% TICI 2a % % 83% site 86.4% 87.5% 88% TICI 2b % 68% Core lab 72.5% 76% 88% 85% 95%

14 Stroke Therapy Evolution Trial Merci Penumbra SWIFT 2012 TREVO 2012 NASA NASA Balloon Guide Solumbra STAR ADAPT FAST Patients /58 90/ Time Window 8 hours 8 hours 8 hours 8 hours 8 hours 8 hours None 8 hours None sich % % 1.7% 7% 9.9% 12.2% 5% 1.5% 0 Mortality 90 days 31-44% 22-45% 18% 34% 30% 26% 29% 6.9% 20% mrs 2 90 days 28-35% 25-40% 37% 40% 42% 52% 44% 58% 40% TICI 2a-3 TICI 2b % % 83% site 75.9% 68% 86.4% 87.5% 88% Core lab 72.5% 76% 88% 85% 95%

15 Lessons Learned ( )

16 Not all revascularization is the same!! TICI Grading Scale Most stroke trials utilize TICI 2a as success.. BUT We should hold ourselves to higher standard!

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18 Final Infarct Volume

19 Spiotta et al. The golden hour of stroke intervention: effect of thrombectomy procedural time in acute ischemic stroke on outcome. JNIS 2014;6:

20 MUSC experience IMPROVED PROCEDURAL TIME TIME TIME Group P Group S Aspiration Penumbra Aspiration N-144 cases Stent Retriever w direct aspiration N=33 cases 34 ADAPT N=44 cases 20

21 Lessons Learned Modern devices (Stent-retrievers/Aspiration) are very good at recanalization Recanalization is a powerful predictor of good outcomes Not all revascularization is the same Final infarct volume (core infarct size) is a strong predictor of outcome Time is of the essence

22 While as all these advances were being made.. WE WERE STUCK IN OLD TRIALS

23 IMS III SYNTHESIS MR RESCUE

24 IMS III

25 IMS III SYNTHESIS

26 IMS III SYNTHESIS MR RESCUE

27 SIGNIFICANT LIMITATIONS

28 The studies did not evaluate patients with large vessel occlusions IMS III Less than half of patients were screened with CTA SYNTHESIS 30% of patients screened with CTA the demonstration of vessel occlusion was not a precondition for inclusion in our trial

29 Modern thrombectomy devices were not the primary means of revascularization IMS III > 75% treated with IA t-pa, EKOS or MERCI 17% treated with Penumbra Aspiration system or Solitaire SYNTHESIS 2/3 rds treated with IA t-pa 1/3 rd treated with Devices (Solitaire, Trevo, Merci, Penumbra) MR RESCUE 64 total IA patients >50% treated with MERCI <20% treated with modern devices

30 Poor rates of recanalization IMS III TICI 2-3 at conclusion (2b-3) ICA occlusion 65% (38%) M1 occlusion 81% (44%) M2 occlusion 70% (44%) Multiple M2 occlusion 77% (23%) MR RESCUE 27% TICI 2b or 3 SYNTHESIS Not Reported

31 Poor Patient selection IMS III Majority of patients imaged with Basic CT head >40% of IMS III patients had baseline ASPECTS 7 SYNTHESIS Only 30% of patients screened with CTA IV t-pa withheld from patients presenting hrs MR RESCUE Favorable penumbral pattern was defined as a predicted infarct core of 90 ml or less Median core infarct size: 60 ml

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33 In patients with baseline CTA occlusion present (pre-specified analysis) Endovascular confers a statistically significant benefit across the spectrum of mrs A. Demchuk, IMS III: Comparison of Outcomes between IV and IV/IA Treatment in Baseline CTA Confirmed ICA, M1, M2 and Basilar Occlusions, slide 20, Presented at ISC 2013, Honolulu Hawaii With CTA-confirmed occlusion at baseline, representative of current practice, IMS III has a statistically significant positive outcome for endovascular 35

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35 MR CLEAN (Multicenter Randomized Clinical Trial of Endovascular Treatment of Acute Stroke in the Netherlands) Objective To asses the effect of intra-arterial treatment on functional outcome after AIS caused by intracranial arterial occlusion, against a background of best medical management Inclusion Criteria Acute Ischemic Stroke Intracranial anterior circulation occlusion (CTA confirmed) IA treatment with 6 hrs from onset Age 18 NIHSS 2 (World Stroke Congress; Istanbul, Turkey October 2014)

36 MR CLEAN (Multicenter Randomized Clinical Trial of Endovascular Treatment of Acute Stroke in the Netherlands) Results Statistically significant positive outcomes for stroke patients with LV anterior circulation occlusion with IA thrombectomy (33% vs. 19% mrs 2) Conclusion Intra-arterial treatment in patients with AIS caused by intracranial anterior circulation occlusion is effective and safe within 6 hours from stroke onset. (ISC, Nashville Feb. 2015)

37 Randomized Trial Status SWIFT PRIME, ESCAPE and EXTEND IA, have been stopped early due to overwhelming efficacy. All major stroke trials comparing catheter-based treatment to medical management have halted enrolling patients in the 0-6 hour window.

38 Strong emphasis on hospital workflow and intervention Door to CT Door to IV CT to Groin Stick Door to Revascularization

39 Lessons Learned Modern devices (Stentretrievers/ADAPT) are very good at recanalization MR CLEAN 97% stent retrievers ESCAPE 86% stent retrievers SWIFT PRIME 100% stent retrievers EXTEND-IA 100% stent retrievers

40 Lessons Learned Modern devices (Stent-retrievers/ADAPT) are very good at recanalization Recanalization is a powerful predictor of good outcomes MR CLEAN 58.7% TICI2B/3 ESCAPE 72.4% TICI 2B/3 SWIFT PRIME 88% TICI 2B/3 EXTEND-IA 86% TICI 2B/3

41 Lessons Learned Modern devices (Stent-retrievers/ADAPT) are very good at recanalization Recanalization is a powerful predictor of good outcomes Not all revascularization is the same Goal of recanalization was 2B/3 not > 2

42 Lessons Learned Final infarct volume (core infarct size) is a strong predictor of outcome Careful selection of patients utilizing ASPECTS and PERFUSION imaging ESCAPE Endovascular treatment for Small Core and Anterior circulation Proximal occlusion with Emphasis on minimizing CT to recanalization times ASPECTS >5 EXTEND IA Extending the time for Thrombolysis in Emergency Neurological Deficits Intra-Arterial selected with a dual target of vessel occlusion and evidence of salvageable tissue on perfusion imaging

43 Lessons Learned Time is of the essence ESCAPE CT Head to groin puncture CT Head to first recanalization 60 min 90 min EXTEND IA Onset to groin puncture within 6 hrs of stroke onset Completion of IAT within 8 hrs of stroke onset SWIFT PRIME Imaging to groin puncture Imaging to stent retriever min min

44 ESCAPE Scores on the Modified Rankin Scale at 90 Days in the Intention-to-Treat Population. Goyal M et al. N Engl J Med DOI: /NEJMoa

45 ESCAPE Scores on the Modified Rankin Scale at 90 Days in the Intention-to-Treat Population. Good Outcome (mrs 0-2): 53% vs. 29%; OR % mrs 2 53% mrs 2 Goyal M et al. N Engl J Med DOI: /NEJMoa

46 SWIFT PRIME

47 SWIFT PRIME 60.2% vs 35.5%

48 EXTEND IA

49 EXTEND IA 72% vs 39%

50 MR CLEAN ESCAPE EXTEND-IA SWIFT PRIME N Device Usage Enrollment Time Window 500 patients IAT Control Open Label - Mostly stent retrievers IAT Control Open Label - 86% Stent Retrievers IAT - 35 Control Only Solitaire (provided free by Covidien) IAT - 98 Control Only Solitaire 6 hrs from symptom onset 12 hrs from symptom onset 4.5 hrs from symptom onset 6 hrs from sympton onset Key Selection Criteria - CTA confirmation LVO - CTA confirmation LVO - Mismatch with ischemic core < 70 ml on CTP - CTA confirmation LVO - ASPECTS 6 Baseline NIHSS - 17 IAT - 18 Control - 16 IAT - 17 Control - 17 IAT - 13 Control 17 both IAT and Control Median ASPECTS 9 both IAT and Control 9 both IAT and Control Not applicable 9 both IAT and Control mrs 90 Days IAT: 32.6% Control: 19.1% IAT: 53% Control: 29.3% IAT: 71% Control: 40% IAT: 61.1% Control: 35.5% Revas Rate of IAT 58.7% TICI 2b/3 72.4% TICI 2b/3 86% TICI 2b/3 88% TICI 2b/3 Mortality at 90 Days IAT: 21% Control: 22% IAT: 10% Control: 19% IAT: 9% Control: 20% IAT: 12.2% Control: 25.8% sich IAT: 7.7% Control: 6.4% IAT: 3.6% Control: 2.7% IAT: 0% Control: 6% IAT: 1.0% Control: 3.1%

51 MR CLEAN ESCAPE EXTEND-IA SWIFT PRIME N Device Usage Enrollment Time Window 500 patients IAT Control Open Label - Mostly stent retrievers IAT Control Open Label - 86% Stent Retrievers IAT - 35 Control Only Solitaire (provided free by Covidien) IAT - 98 Control Only Solitaire 6 hrs from symptom onset 12 hrs from symptom onset 4.5 hrs from symptom onset 6 hrs from sympton onset Key Selection Criteria - CTA confirmation LVO - CTA confirmation LVO - ASPECTS 6 - Moderate/Good Collaterals - CTA confirmation LVO - Mismatch with ischemic core < 70 ml on CTP - CTA confirmation LVO - ASPECTS 6 Baseline NIHSS - 17 IAT - 18 Control - 16 IAT - 17 Control - 17 IAT - 13 Control 17 both IAT and Control Median ASPECTS 9 both IAT and Control 9 both IAT and Control Not applicable 9 both IAT and Control mrs 90 Days IAT: 32.6% Control: 19.1% IAT: 53% Control: 29.3% IAT: 71% Control: 40% IAT: 61.1% Control: 35.5% Revas Rate of IAT 58.7% TICI 2b/3 72.4% TICI 2b/3 86% TICI 2b/3 88% TICI 2b/3 Mortality at 90 Days IAT: 21% Control: 22% IAT: 10% Control: 19% IAT: 9% Control: 20% IAT: 12.2% Control: 25.8% sich IAT: 7.7% Control: 6.4% IAT: 3.6% Control: 2.7% IAT: 0% Control: 6% IAT: 1.0% Control: 3.1%

52 MR CLEAN ESCAPE EXTEND-IA SWIFT PRIME N Device Usage Enrollment Time Window 500 patients IAT Control Open Label - Mostly stent retrievers IAT Control Open Label - 86% Stent Retrievers IAT - 35 Control Only Solitaire (provided free by Covidien) IAT - 98 Control Only Solitaire 6 hrs from symptom onset 12 hrs from symptom onset 4.5 hrs from symptom onset 6 hrs from sympton onset Key Selection Criteria - CTA confirmation LVO - CTA confirmation LVO - ASPECTS 6 - Moderate/Good Collaterals - CTA confirmation LVO - Mismatch with ischemic core < 70 ml on CTP - CTA confirmation LVO - ASPECTS 6 Baseline NIHSS - 17 IAT - 18 Control - 16 IAT - 17 Control - 17 IAT - 13 Control 17 both IAT and Control Median ASPECTS 9 both IAT and Control 9 both IAT and Control Not applicable 9 both IAT and Control mrs 90 Days IAT: 32.6% Control: 19.1% IAT: 53% Control: 29.3% IAT: 72% Control: 40% IAT: 60.2% Control: 35.5% Revas Rate of IAT 58.7% TICI 2b/3 72.4% TICI 2b/3 86% TICI 2b/3 88% TICI 2b/3 Mortality at 90 Days IAT: 21% Control: 22% IAT: 10% Control: 19% IAT: 9% Control: 20% IAT: 12.2% Control: 25.8% sich IAT: 7.7% Control: 6.4% IAT: 3.6% Control: 2.7% IAT: 0% Control: 6% IAT: 1.0% Control: 3.1%

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54 SW 77 yo female with acute onset right sided facial, UE and LE weakness. Time of onset ~4.5 hours. Brought to TMH by family, seen by neurology in ER PMHx: Afib, DM, HTN INR 2.1 Neuro exam: intubated, eyes open to stimulateion, plegic RUE, wiggles Right ties to command, FSC/antigravity Left side NIHSS 8

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56 SW Not a tpa candidate because of INR Taken for CT Angiogram and CT Perfusion

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59 Taken for mechanical thrombectomy within 40 minutes of arrival

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61 Solitaire 2 4x40mm stentriever

62 One pass with Solitaire

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64 Postop Awake, alert, fluent speech Full strength in all four extremities

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66 Conclusion There is (Level 1) evidence that IA thrombectomy is beneficial for patients with AIS and LVO within 0-6 hrs.