NKC 1:14 23, 2016 原著 Penumbra 5MAX ACE の初期 7 例の使用経験多喜純也早瀬睦宮腰明典北原孝宏服部悦子中村威彦波多野武人要旨目的 Penumbra 5MAX ACE を用いて a direct aspiration first pass techniqu

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1 NKC 1:14 23, 2016 原著 Penumbra 5MAX ACE の初期 7 例の使用経験多喜純也早瀬睦宮腰明典北原孝宏服部悦子中村威彦波多野武人要旨目的 Penumbra 5MAX ACE を用いて a direct aspiration first pass technique(adapt) を行った初期経験に基づき, 有用性を報告する. 方法 2014 年 10 月から 2015 年 3 月の間に血栓回収療法を行った連続 8 症例のうち,5MAX ACE を吸引カテーテルあるいは中間径カテーテルとして用い ADAPT を行った 7 例を後方視的に解析した. 結果平均年齢 76.9 歳. 閉塞部位は中大脳動脈 M1 遠位 3 例,M2 2 例, 脳底動脈 2 例. 治療前平均 National Institutes of Health Stroke Scale(NIHSS) 16.0, 治療開始までの平均時間は 315 分.5 例 (M1 遠位 2 例,M2 1 例,BA 2 例 ) で 5MAX ACE が閉塞部位に到達し,2 例は同軸に用いた 3MAX で ADAPT を施行.6 例で有効な再開通 (Thrombolysis in Cerebral Infarction[TICI]3 5 例,TICI 2b 1 例 ) を得た. 治療 24 時間後 NIHSS は平均 7.7 であった. 手技に伴う頭蓋内出血は認めなかった. 結論 5MAX ACE は口径が拡大したが, 追従性にも優れており, より安全, 有効に血栓回収が行えるものと考えられた. Key words 5MAX ACE, Penumbra, ADAPT, mechanical thrombectomy NKC 1:14 23, 2016 緒言 Penumbra system Penumbra Inc. Alameda, CA, USA MAX MAX ACE Penumbra system separator separator a direct aspiration first pass technique ADAPT 2 Penumbra system ADAPT 5MAX ACE jtaki6@gmail.com Tel: Fax:

2 対象と方法対象 5MAX ACE MAX ACE CT MRI diffusion-weighted image: DWI MRA internal carotid artery: ICA middle cerebral artery: MCA M1 M2 A1 A2 Alberta Stroke Program Early CT Score ASPECTS +W ASPECTS vertebral artery: VA basilar artery: BA P1 P2 posterior circulation-acute Stroke Prognosis Early CT Score pc-aspects DWI DWI MRI CT ASPECTS 6 National Institutes of Health Stroke Scale NIHSS Tissue plasminogen activator tpa t PA 血管内治療 Penumbra system ADAPT 4Fr 4Fr OK2 9Fr 9Fr Optimo 6Fr JB2 ICA 6Fr Fubuki 6Fr JB2 VA tpa MAX ACE 3MAX CHIKAI cm 60 ml Penumbra 5MAX ACE Optimo balloon 5MAX ACE Optimo 3 4 5MAX ACE 3MAX ADAPT ADAPT M1 BA 3MAX stent retriever SR 評価項目 onset-to-puncture time: OPT 5MAX ACE Thrombolysis in Cerebral Infarction TICI 2b puncture-to-reperfusion time: PRT intracranial hemorrhage: ICH PRT 24 NIHSS 24 dramatic recovery DR: NIHSS modified Rankin Scale mrs embolization to new territory: ENT CT subarachnoid hemorrhage: SAH 15

または ICH とした CT は治療直後 24 時間後そ MRI 所見 DWI にて左島皮質と後部側頭葉皮質にの後は必要に応じて撮影した ICH により NIHSS が高信号域を左放線冠にも淡い高信号域を認め 4 以上増悪したものを症候性頭蓋内出血 symptomatic ASPECTS+W は 8 であった Fig.

3 または ICH とした CT は治療直後 24 時間後そ MRI 所見 DWI にて左島皮質と後部側頭葉皮質にの後は必要に応じて撮影した ICH により NIHSS が高信号域を左放線冠にも淡い高信号域を認め 4 以上増悪したものを症候性頭蓋内出血 symptomatic ASPECTS+W は 8 であった Fig. 1A 1B MRA では ICH: sich とした MCA M2 後方枝の信号が途絶していた血管内治療 tpa 静注開始 5 分後より血管造影を開始代表症例し左 M2 後方枝の閉塞を確認した Fig. 1C 1D 症例 1 76 歳女性 9Fr シースに入れ替えヘパリン静注の後 9Fr Optimo を現病歴不調を自覚し近隣の家族に自ら電話した呂 ICA に留置した 5MAX ACE を 3MAX と同軸に誘導律が回っていないため家族により救急要請され搬送し容易に M2 の閉塞部位に到達した Fig. 1E ICA された遮断下に ADAPT を施行しやや白色の血栓を回収し既往歴高血圧糖尿病膵癌多発肝転移があり末 Fig. 1H 再開通 TICI 3 を確認した Fig. 1F 1G 期の状態術後経過術直後から右片麻痺は改善し NIHSS 入院時所見 Japan Coma Scale I-3 発症直後は不明瞭 12 翌日には失語もほぼ消失し歩行可能となったな発語があったが来院時は失語症構音障害顔面 NIHSS 1 3 日後には神経脱落症状は完全に消失しを含む重度の右不全片麻痺 manual muscle testing: 2/5 た経過中も心房細動は認めず入院時採血で血小板を認めた NIHSS は 16 であった心電図は洞調律で低値や線溶系の亢進を認めたため癌末期の凝固異常あったが関連した塞栓症と考えられた出血リスクや内服抗 A B C D G H F E Fig. 1 In Case 1, preoperative diffusion-weighted image (DWI) shows hyperintense areas in the left insular cortex, left posterior temporal cortex (A), and subcortical white matter of the corona radiata (B, arrow). Left internal carotid angiography (ICAG) shows occlusion at the M2 segment of the middle cerebral artery (C, D, arrows). The 5MAX ACE is advanced to the occlusion site (E, arrow) and thrombus is removed by a direct aspiration first pass technique (F). Post-procedural left ICAG reveals thrombolysis in cerebral infarction (TICI) 3 recanalization (G, H). 16

4 結果 4MAX 1 7 5MAX ACE Table ± OPT 315±309 NIHSS 16.0±6.6 MRI ASPECTS+W M1 M1 5 mm 7 3 M2 2 BA 2 tpa MAX ACE 1 ICA M1 ICA 7 7 M1 ADAPT M2 Fig. 2A 3 pass ADAPT Fig. 2B 2C M2 2 5MAX ACE ADAPT M1 4 ICA Fig. 2D 5MAX ACE ICA C4 Fig. 2E 3MAX ADAPT Fig. 2F 5MAX ACE M2 5 Fig. 2G M1 5MAX ACE 3MAX ADAPT 3 pass 4MAX ADAPT Fig. 2H 2I TICI TICI 3 PRT 76±48 5MAX ACE SR 24 NIHSS 7.7± DR 4 4 PRT PRT GC 7 ICA 24 DR mrs ICH M MAX ACE ADAPT M1 3 MRA 6 Table 1 Case Age (year) Patient characteristics and results of endovascular procedure Sex Etiology Occlusion site ASPECTS+W / pc-aspects tpa OPT (min) Advancement of 5MAX ACE Number of aspirations TICI PRT (min) NIHSS before procedure NIHSS 24 h after procedure 1 76 F unknown Left M M2 1 pass TICI F CE BA 9 * BA 4 pass TICI M CE Left M1 distal M1 distal 1 pass TICI F CE Right M1 distal IC C4 1 pass TICI M CE Left M M1 distal N/A TICI 1 N/A M ATBI BA 9 * 118 BA 1 pass TICI 2b M ATBI Left M1 distal M2 3 pass TICI CE, cardiac embolism; ATBI, atherothrombotic brain infarction; DWI, diffusion-weighted image; ASPECTS, Alberta Stroke Program Early CT Score; tpa, tissue plasminogen activator; IC, internal carotid artery; BA, basilar artery; OPT, onset to puncture time; PRT, puncture to reperfusion time; TICI, thrombolysis in cerebral infarction; NIHSS, National Institutes of Health Stroke Scale. *pc-aspects 17

5 Table 2 Comparison of the results from the recent studies using Penumbra system and/or ADAPT Penumbra Pivotal 8) SPEED 9) POST trial Stroke Trial study 10) Jankowitz et ADAPT FAST 2) Kowoll et al. 11) al.20) Our study Total 5 MAX 5 MAX ACE Total ADAPT ADAPT+stent Number of patients Mean age (median) (median) 72 (median) 59 (median) 76.9 NIHSS at presentation (mean±sd) 17.6±5.2 16±6 18.2± (12 20) * 17.2± (2 27) ** 14 (2 27) ** 16 (6 24) ** 16.0±6.6 Site of occlusion ICA MCA Vertebrobasilar ICA (%) ICA-terminal (%) M1 proximal (%) M1 distal (%) M2 (%) VA (%) 15 BA (%) PCA (%) 1.9 others (%) Device Penumbra system Penumbra system Result Mean time from puncture to recanalization (min) Penumbra 054 ADAPT (DAC, Penumbra) Penumbra ADAPT 5MAX ACE iv tpa (%) N/A 18.5 N/A N/A TICI 2/TIMI 2 TICI 2a (%) (%) TICI 2b (%) TICI 3/ TIMI 3 (%) Dramatic recovery after 24 h (%) 32 (at discharge) 36.3 (at discharge) Penumbra ADAPT N/A N/A N/A N/A 57.1 mrs 2 at 90 days (%) # 53.3 # 37.5 # 14.3 # mrs 6 at 90 days (%) # 3.3 # 20.8 # 0.0 # Adverse event NIHSS (mean±sd) N/A N/A N/A N/A 7.3±7.5 (at discharge) 6 (0 24) ** 4 (0 24) ** 7 (0 24) ** 7.7±8.1 (24 h later) ICH (%) ## ## N/A N/A 0.0 sich (%) ## 14.0 N/A 0.0 ## ICA: internal carotid artery, MCA: middle cerebral artery, VA: vertebral artery, BA: basilar artery, PCA: posterior cerebral artery, ADAPT: a direct aspiration first pass technique, tpa: tissue plasminogen activator TICI: thrombolysis in cerebral infarction, TIMI: thrombolysis in myocardial infarction, mrs: modified Rankin Scale, NIHSS: National Institutes of Health Stroke Scale ICH: intracranial hemorrhage, sich: symptomatic ICH, ## intracerebral (parenchymal) hemorrhage * Median (interquartile range), ** Median (range), Median time from aspiratiom initiation to final aspiration use, Median time from groin puncture to recanalization, # mrs at discharge 18

6 A B C D E F G H I Fig. 2 In Case 7, the left common carotid angiography (CCAG) shows thrombus remaining in the M2 segment of the middle cerebral artery (MCA) after two passes of a direct aspiration first pass technique (ADAPT) (A, arrow). The 5MAX ACE is advanced to M2 (B, arrow) and thrombolysis in cerebral infarction (TICI) 3 is achieved by the third aspiration (C). In Case 4, right internal carotid angiography (ICAG) shows occlusion in the distal part of M1 segment of the MCA (D, arrow). The cervical portion of the internal carotid artery (ICA) is tortuous (D). The 5MAX ACE is advanced at the C4 (cavernous) segment of the ICA (E, arrow), and 3MAX reaches the occlusion site (E, arrowhead). TICI 3 recanalization is achieved by ADAPT through 3MAX (F). In Case 5, left ICAG shows occlusion at the M2 segment of the MCA (G, arrow). The 5MAX ACE is advanced to the distal portion of the M1 segment of the MCA (H, I, arrows). We tried ADAPT by coaxially advancing the 3MAX to the occlusion site (H, I, arrowheads), but recanalization was not achieved. 考察 SR Penumbra system Table 2 Penumbra system Penumbra Pivotal Stroke Trial POST trial separator Thrombolysis in Myocardial Infarction TIMI ,9 SPEED study 054 separator TIMI ADAPT ADAPT FAST A Direct Aspiration first Pass Technique For Acute 19

7 Stroke Thrombectomy 2 Kowoll 11 5MAX TICI 2b 75 5MAX ACE 82 5MAX ACE MAX ACE ADAPT SR TICI 2b 93.6 TICI TIMI TICI ADAPT Penumbra system SR Merci RCT TREVO2 Trevo versus Merci retrievers for thrombectomy revascularization of large vessel occlusions in acute ischaemic stroke SWIFT Solitaire flow restoration device versus the Merci Retriever in patients with acute ischaemic stroke SR TREVO2 TICI SWIFT TIMI ,13 RCT SR TICI 2b ADAPT SR Turk Penumbra system Separator Penumbra+Separator: PS SR SR+Local Aspiration: SRLA ADAPT TICI 2b PS 42 SRLA 80 ADAPT 78 ADAPT SRLA PS ADAPT SRLA 5MAX ACE TICI 2b 85.7 TICI TICI 3 19 PRT Jankowitz Distal Access Catheter DAC: Concentric Medical, MountainView, CA, USA Penumbra manual aspiration ADAPT FAST Kowoll ADAPT ,11,20 SR TREVO2 SWIFT GC ,13 SR RCT PRT ADAPT SR Turk PRT PS 87.7 SRLA 46.8 ADAPT 37.1 p< SRLA SR ADAPT SRLA PS PRT 75.7 GC DR ADAPT Penumbra Pivotal Stroke Trial POST trial DR ,9 ADAPT ADAPT FAST Kowoll DR NIHSS ,11 Penumbra system ADAPT 90 mrs ,8 10,20 Kowoll mrs SR RCT 90 mrs mrs 14.3 Table 2 mrs 90 mrs DR ADAPT 5MAX ACE ICA 22 M1 3 5 M MAX ACE 20

8 multiple coaxial system MAX ACE 3MAX SR 24 SR 21,24 M2 5 5MAX ACE 3MAX ADAPT 5MAX ACE SR SRLA ADAPT pass 2 BA VA 7 ICA 1 pass SR NASA registry North American Solitaire Stent Retriever Acute Stroke registry GC TICI 3 25 Turk ADAPT 26 ADAPT ICH ICH Table 2 Penumbra 054 +separator SPEED study ICH sich DAC Penumbra Jankowitz MAX 5MAX ACE ADAPT FAST 0 2 5MAX ACE Kowoll sich MAX 5MAX ACE ICH SR SAH ADAPT SAH 2,11,20 SR TREVO2 SAH 8 SAH SWIFT SAH 1.7 SAH SR SAH SAH 5MAX ACE ADAPT SAH Penumbra Pivotal Stroke trial SPEED study ,10 SWIFT SR ADAPT ENT ADAPT Turk SR TREVO2 SWIFT SR RCT ,15,18 ADAPT SR ENT Kowoll 6 11 ADAPT FAST 0 2 ADAPT SR SWIFT TREVO RCT ,16,18 ENT Humphries SRLA 105 ENT ENT 24 5MAX ACE ADAPT ADAPT ENT SRLA 結論 5MAX ACE 7 21

9 5MAX ACE 利益相反の開示 References 1 Hu YC and Stiefel MF: Force and aspiration analysis of the ADAPT technique in acute ischemic stroke treatment. J Neurointerv Surg 2015 (Epub ahead of print). 2 Turk AS, Frei D, Fiorella D, et al: ADAPT FAST study: a direct aspiration first pass technique for acute stroke thrombectomy. J Neurointerv Surg 2014; 6: Barber PA, Demchuk AM, Zhang J, et al: Validity and reliability of a quantitative computed tomography score in predicting outcome of hyperacute stroke before thrombolytic therapy. ASPECTS Study Group. Alberta Stroke Programme Early CT Score. Lancet 2000; 355: Kawano H, Hirano T, Nakajima M, et al: Modified ASPECTS for DWI including deep white matter lesions predicts subsequent intracranial hemorrhage. J Neurol 2012; 259: Puetz V, Sylaja PN, Coutts SB, et al: Extent of hypoattenuation on CT angiography source images predicts functional outcome in patients with basilar artery occlusion. Stroke 2008; 39: Felberg RA, Okon NJ, El-Mitwalli A, et al: Early dramatic recovery during intravenous tissue plasminogen activator infusion: clinical pattern and outcome in acute middle cerebral artery stroke. Stroke 2002; 33: Hirano T, Sasaki M, Mori E, et al: Residual vessel length on magnetic resonance angiography identifies poor responders to alteplase in acute middle cerebral artery occlusion patients: exploratory analysis of the Japan Alteplase Clinical Trial II. Stroke 2010; 41: Tarr R, Hsu D, Kulcsar Z, et al: The POST trial: initial postmarket experience of the Penumbra system: revascularization of large vessel occlusion in acute ischemic stroke in the United States and Europe. J Neurointerv Surg 2010; 2: Penumbra Pivotal Stroke Trial Investigators: The penumbra pivotal stroke trial: safety and effectiveness of a new generation of mechanical devices for clot removal in intracranial large vessel occlusive disease. Stroke 2009; 40: Frei D, Gerber J, Turk A, et al: The SPEED study: initial clinical evaluation of the Penumbra novel 054 Reperfusion Catheter. J Neurointerv Surg 2013; 5 Suppl 1: i Kowoll A, Weber A, Mpotsaris, A, et al: Direct aspiration first pass technique for the treatment of acute ischemic stroke: initial experience at a European stroke center. J Neurointerv Surg 2015 (Epub ahead of print). 12 Nogueira RG, Lutsep HL, Gupta R, et al: Trevo versus Merci retrievers for thrombectomy revascularisation of large vessel occlusions in acute ischaemic stroke (TREVO 2): a randomised trial. Lancet 2012; 380: Saver JL, Jahan R, Levy EI, et al: Solitaire flow restoration device versus the Merci Retriever in patients with acute ischaemic stroke (SWIFT): a randomised, parallel-group, noninferiority trial. Lancet 2012; 380: Berkhemer OA, Fransen PS, Beumer D, et al: A randomized trial of intraarterial treatment for acute ischemic stroke. N Engl J Med 2015; 372: Goyal M, Demchuk AM, Menon BK, et al: Randomized assessment of rapid endovascular treatment of ischemic stroke. N Engl J Med 2015; 372: Campbell BC, Mitchell PJ, Kleinig TJ, et al: Endovascular therapy for ischemic stroke with perfusion-imaging selection. N Engl J Med 2015; 372: Saver JL, Goyal M, Bonafe A, et al: Stent-retriever thrombectomy after intravenous t-pa vs. t-pa alone in stroke. N Engl J Med 2015; 372: Jovin TG, Chamorro A, Cobo E, et al: Thrombectomy within 8 hours after symptom onset in ischemic stroke. N Engl J Med 2015; 372: Prabhakaran S, Ruff I, Bernstein RA: Acute stroke intervention: a systematic review. JAMA 2015; 313: Jankowitz B, Aghaebrahim A, Zirra A, et al: Manual aspiration thrombectomy: adjunctive endovascular recanalization technique in acute stroke interventions. Stroke 2012; 43: Turk AS, Turner R, Spiotta A, et al: Comparison of endovascular treatment approaches for acute ischemic stroke: cost effectiveness, technical success, and clinical outcomes. J Neurointerv Surg 2015; 7: John S, Hussain MS, Toth G, et al: Initial Experience Using the 5MAX ACE Reperfusion Catheter in Intra-arterial Therapy for Acute Ischemic Stroke. J Cerebrovasc Endovasc Neurosurg 2014; 16: Kulcsár Z, Yilmaz H, Bonvin C, et al: Multiple coaxial catheter system for reliable access in interventional stroke therapy. Cardiovasc Intervent Radiol 2010; 33: Humphries W, Hoit D, Doss VT, et al: Distal aspiration with retrievable stent assisted thrombectomy for the treatment of acute ischemic stroke. J Neurointerv Surg 2015; 7: Nguyen TN, Malisch T, Castonguay AC, et al: Balloon guide catheter improves revascularization and clinical outcomes with the Solitaire device: analysis of the North American Solitaire Acute Stroke Registry. Stroke 2014; 45: Turk AS, Spiotta A, Frei D, et al: Initial clinical experience with the ADAPT technique: a direct aspiration first pass technique for stroke thrombectomy. J Neurointerv Surg 2014; 6:

10 Initial Experience of Penumbra 5MAX ACE in 7 Cases with Acute Occlusion of Cerebral Arteries Junya TAKI Makoto HAYASE Akinori MIYAKOSHI Takahiro KITAHARA Etsuko HATTORI Takehiko NAKAMURA Taketo HATANO Department of Neurosurgery, Fukui Red Cross Hospital Objective: We report our initial experience with 5MAX ACE and discuss its utility for mechanical thrombectomy. Methods: Among eight consecutive patients who underwent mechanical thrombectomy from October 2014 to March 2015, we retrospectively reviewed the seven patients treated using a direct aspiration first pass technique (ADAPT) with the Penumbra 5MAX ACE as either the aspiration catheter or the intermediate catheter. Results: The mean age was 76.9 years. Mean National Institutes of Health Stroke Scale (NIHSS) score was The mean time from symptom onset to endovascular treatment was 315 minutes. Occlusion sites were the distal part of the M1 segment of the middle cerebral artery (MCA) in 3 cases, the M2 segment of the MCA in 2 cases, and the basilar artery in 2 cases. In 5 cases (distal M1, 2 cases; M2, 1 case; BA, 2 cases), the 5MAX ACE reached the occlusion site. In the other 2 cases (distal M1 and M2), a 3MAX was advanced coaxially through the 5MAX ACE to the occlusion site. Successful recanalization ( thrombolysis in cerebral infarction [TICI] 2b) was achieved by ADAPT in 6 cases (TICI 3, 5 cases; TICI 2b, 1 case). The mean NIHSS score at 24 hours after procedure was 7.7. No procedure-related intracranial hemorrhages were observed. Conclusion: The 5MAX ACE in combination with ADAPT is useful for mechanical thrombectomy because of the large-bore catheter and good trackability. NKC 1:14 23,

HO_edit 脳梗塞の血管内治療.pptx

HO_edit 脳梗塞の血管内治療.pptx 脳梗塞の血管内治療 N Engl J Med 2015; 372:11-20 N Engl J Med 2015; 372:1019-1030 N Engl J Med 2015; 372:1009-1018 慈恵 ICU 勉強会 2015 年 3 月 31 日石垣昌志急性期脳梗塞治療戦略の基本概念閉塞している血管の再開通ペナンブラ領域を救済予後が改善慈恵 ICU 火曜勉強会脳梗塞ガイドライン

NKC 1:14 23, 2016 原著 Penumbra 5MAX ACE の初期 7 例の使用経験 多喜純也早瀬睦宮腰明典北原孝宏服部悦子中村威彦波多野武人 要 旨 目的 Penumbra 5MAX ACE を用いて a direct aspiration first pass techniqu

NKC 1:14 23, 2016 原著 Penumbra 5MAX ACE の初期 7 例の使用経験多喜純也早瀬睦宮腰明典北原孝宏服部悦子中村威彦波多野武人要旨目的 Penumbra 5MAX ACE を用いて a direct aspiration first pass techniqu