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The Catch Mini Stent Retriever for Mechanical Thrombectomy in distal intracranial occlusions

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The Catch Mini Stent Retriever for Mechanical Thrombectomy in distal intracranial occlusions

HOFMEISTER, Jérémy, et al.

Abstract

Mechanical thrombectomy (MTB) is a treatment of reference for acute ischemic stroke due to large brain vessel occlusion but some concerns remain about its use in small distal branches.

In the present study, we assessed the efficacy and the safety of distal MTB using the Catch Mini (CM) stent retriever.

HOFMEISTER, Jérémy, et al. The Catch Mini Stent Retriever for Mechanical Thrombectomy in distal intracranial occlusions. Journal of Neuroradiology, 2018

PMID : 29410105

DOI : 10.1016/j.neurad.2018.01.051

Available at:

http://archive-ouverte.unige.ch/unige:103245

Disclaimer: layout of this document may differ from the published version.

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Title: The Catch Mini Stent Retriever for Mechanical Thrombectomy in distal intracranial occlusions Author: Jeremy Hofmeister Zsolt Kulcsar Gianmarco Bernava Alain Pellaton Hasan Yilmaz Gorislav Erceg Maria Isabel Vargas Karl-Olof Lovblad Paolo Machi

PII: S0150-9861(17)30459-5

DOI: https://doi.org/doi:10.1016/j.neurad.2018.01.051

Reference: NEURAD 703

To appear in: Journal of Neuroradiology Received date: 6-10-2017

Accepted date: 2-1-2018

Please cite this article as: Hofmeister J, Kulcsar Z, Bernava G, Pellaton A, Yilmaz H, Erceg G, Vargas MI, Lovblad K-O, Machi P, The Catch Mini Stent Retriever for Mechanical Thrombectomy in distal intracranial occlusions,Journal of Neuroradiology (2018), https://doi.org/10.1016/j.neurad.2018.01.051

This is a PDF file of an unedited manuscript that has been accepted for publication.

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The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

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Title Page

Title :

The Catch Mini Stent Retriever for Mechanical Thrombectomy in distal intracranial occlusions

Authors :

Jeremy Hofmeister 1, Zsolt Kulcsar 2, Gianmarco Bernava 3, Alain Pellaton 3, Hasan Yilmaz 3, Gorislav Erceg 3, Maria Isabel Vargas 3, Karl-Olof Lövblad 3, Paolo Machi 3

Affiliations :

1. Service of Radiology, University Hospital of Geneva, Geneva, Switzerland 2. Service of Neuroradiology, University Hospital of Zurich, Zurich, Switzerland 3. Service of Neuroradiology, University Hospital of Geneva, Geneva, Switzerland

* Corresponding author :

Dr Paolo Machi, Service of Neuroradiology, University Hospital of Geneva, Rue Gabrielle- Perret-Gentil 4, 1205 Geneva, Switzerland. Email : paolo.machi@hcuge.ch

Acknowledgements :

We would like to thank Dr. Kim Wiskott for helpful discussions.

Competing interests :

The authors declare no competing financial interests.

Abstract Objective:

Mechanical thrombectomy (MTB) is a treatment of reference for acute ischemic stroke due to large brain vessel occlusion but some concerns remain about its use in small

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distal branches. In the present study, we assessed the efficacy and the safety of distal MTB using the Catch Mini (CM) stent retriever.

Methods:

We retrospectively reviewed a prospectively maintained database of all consecutive patients who underwent MTB for a distal intracranial occlusion with the Catch Mini device at our hospital.

Results:

Forty-one patient underwent MTB for distal intracranial occlusions using the CM stent retriever. Good capillary reperfusion (TICT≥2b) was observed in 32 out of 41 patients (78%). Focal ischemia within the territory vascularized by the artery addressed by the CM was observed in 8 patients (19.5%). Post-procedural vasospasm was observed in 8 patients, all responding rapidly to vasodilatator administration. Two asymptomatic hemorrhages (4.9%) were noted on follow-up imaging (one patechial hemorrhage and one parenchymal hematoma) in patients with M2 occlusions. No vessel rupture were observed. Overall, good neurological outcome at three months (mRS ≤2) was observed in 28 (out of 34 patients followed; 82,4%) of patients.

Conclusions:

Our single-center experience shows that the CM stent retriever is safe and effective for the recanalization of small diameter distal branches feeding eloquent brain areas.

Keywords : stroke; mechanical thrombectomy; distal occlusion; stent retriever;

interventional neuroradiology

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Introduction

Stent retriever based mechanical thrombectomy (MTB) is a treatment of reference for acute ischemic stroke (AIS) due to a large brain vessel occlusion [1-2], as demonstrated by several recent randomized clinical trials [3-8]. Trials demonstrated the efficacy and safety of MTB in patients presenting with large proximal brain vessels but patients presenting with distal intracranial occlusions were not included in these studies. In the daily practice clinicians have to manage with patients presenting with AIS due to the occlusion of a distal vessel feeding an eloquent brain area. The recent availability of small diameter, low profile stent retrievers enables operators to address such distal occlusions; nevertheless the benefit of MTB performed in thin, distal vessels remains matter of debate.

In the present study, we aimed to retrospectively assess the efficacy and the safety of MTB performed at our institution with Catch Mini (CM) (Balt, Montmorency, France), a 3x20 mm nitinol, low profile, laser-cut stent retriever (Figure 1), in a series of patients victims of AIS presenting with a distal, eloquent intracranial vessel occlusion.

Materials and methods

The ethics board of our institution approved the study protocol. We retrospectively reviewed a prospective maintained database of all consecutive patients who underwent MTB at our institution between January 2014 and December 2016 to analyze results of patients treated for a distal intracranial occlusion with CM.

Upon admission at the hospital, patients with stroke suspicion on clinical exam underwent brain perfusion CT scan. Selection of patients for all MTB was based on perfusion CT scans, following standard practice (CBV < 70 ml and mismatch ratio > 1.8 as computed with the RAPID software) [9]. In case of primary occlusion of a proximal vessel, the choice of the MTB technique was left to operator preference. In such cases, the CM was used as rescue device following distal thrombo-embolism of the initial proximal clot (i.e. secondary occlusion). In cases of primary occlusion of a small vessel feeding eloquent brain area, the CM was used as front-line device. In all cases of failure to remove distal clot using CM device, the procedure was stopped and no other stent retriever was used. The time interval between the onset of symptoms, perfusion CT scan, groin puncture and the end of the interventional procedure were recorded.

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Clinical and radiological data of patients treated within the study period were reviewed by two operators with experience in MTB (PM and GMB). Clot location was defined according to the standard definition [10]; distal occlusion was considered for clot located at the second (M2) and the third (M3) portion of middle cerebral artery (MCA), the second (A2) and the third (A3) portion of the anterior cerebral artery (ACA), and the second (P2) and the third (P3) portion of the posterior cerebral artery (PCA). The degree of target artery reperfusion was assessed according to the modified Thrombolysis In Cerebral Infarction (TICI) score [11]. A mTICI score of ≥2b was considered for successful recanalization. Immediate post retrieval DSA control were analyzed to identify the presence of target vessel vasospasm and rupture. Vessel vasospasm was considered for a vessel diameter reduction of >50% [12]. Immediate post-operative XperCT scans (Allura Xper FD20; Philips Healthcare, Best, the Netherlands) and the 24 hours follow-up dual energy CT scan were reviewed to evaluate the presence of ischemic lesions and hemorrhagic complications. Hemorrhagic complications were defined according to the ECASS III (European Cooperative Acute Stroke Study [13]) criteria. Neurological outcome at three months was documented using the modified Ranking Scale (mRS) days.

Results

From January 2014 to December 2016, 41 patients underwent MTB with CM device at our center. Demographic and clinical variables are reported in Table 1. The CM was used either as a front-line device, in case of primary occlusion of a small eloquent vessel, or as a rescue device in cases of distal thrombo-embolism of a more proximal clot previously addressed with another device (secondary occlusion). In 20 cases (out of 41; 48.8%) CM was used as a front-line device. In the remaining 21 cases (out of 41; 51.2%) it was employed as a rescue device after embolic complication of a proximal clot previously addressed with other techniques. In such cases proximal clots were firstly addressed with the following approaches: ADAPT technique (A Direct Aspiration first Pass Technique [14]) (17 patients), standard size (4-6 mm in diameter) stent retriever based MTB (12 patients), Solumbra technique [15] (12 patients). Thirty-eight patients (out of 41; 92.7%) received intravenous rt-PA before the endovascular procedure. The distribution of distal vessels addressed with CM was as follows: M2 segment=28 cases,

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M3 segment=6 cases, A2 segment=2 cases, P2 segment=4 cases and P3 segment=1 case (Table 1). In 16 cases (out of 41; 39.0 %), the use of CM was associated to concomitant thromboaspiration. In such instances, the device was delivered through an intermediate aspiration catheter connected to an aspirating system which was activated during the stent retrieval. The median time interval between symptoms onset to CT scan was 165 minutes (interquartile range: 135-220), time to groin puncture was 210 min (150-245) and time to the end of the endovascular intervention was 290 min (220-360).

Successful recanalization (mTICI ≥2b) was observed in 32 patients (out of 41; 78.0%;

Figure 2). In 9 cases (out of 41; 22.0%), CM was not effective in adequate reperfusion, resulting in a TICI score of 1 for one patient (1 out of 41; 2.4%) and 0 for the remaining eight patients (out of 41; 19.5%). The higher rate of successful target artery recanalization was recorded for M2 occlusions (23 out of 28 patients; 82.1%). Focal ischemia within the territory vascularized by the artery treated with CM was observed in the post-operative CT scan control in 8 cases (out of 41; 19.5%). In the remaining 33 patients (out of 41; 80.4%) CM was effective in allowing the rescue of the territory vascularized by the treated vessel.

Two hemorrhagic complications (out of 41; 4.9%) were observed at 24h follow-up dual- energy CT scan: one patechial hemorrhage (HI2) and one parenchymal hematoma (PH2), respectively. Both complications occurred in patients with M2 occlusions and were asymptomatic. In four cases a focal amount of contrast media located in the extravascular space along the portion of the target artery treated with CM was observed on the immediate post- operative XperCT scan (4 out of 41 patients; 9.8%) (Figure 3).

All these patients were asymptomatic and the following 24h dual-energy CT scan showed the disappearance of the extravascular contrast media. Significant vasospasm was observed in post-procedural DSA in 8 patients (out of 41; 19.5%), in all cases vasospasm completely responded to intra-arterial vasodilator infusion (2mg of Nimodipine). No cases of intra-operative vessel rupture were observed in the present series.

Three patients died during the three months following MTB with the CM: two patient died from stroke-related complications, due to the severity of the evolving infarct, while one patient died as a result of cancer. Three-month mRS follow-up was available for 34 patients treated with the CM (out of 38 patients alive ; 89,5%). Median mRS at 3 months was 2, and 28 (out of 34) patients had a mRS of ≤2 (82,4%).

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Discussion

MTB is a treatment of reference for AIS due to large brain vessel occlusion but some concerns remains about its employ in small, distal branches. Efficacy and safety of such approach have been evaluated in a subgroup analysis of the PROACT-II [16] trial. In this study the rate of adequate reperfusion of M2 occlusion was higher for patients treated by MTB (in association or not with rt-PA) as compared to rt-PA alone. Moreover, a post- hoc analysis of STAR, SWIFT and SWIFT-PRIME studies showed that MTB achieved similar or even higher reperfusion rate when performed in distal M2 branches as compared to proximal M1 occlusions [17]. A number of retrospective series showed promising results in the treatment of AIS using a novel low profile stent retrievers ([18- 20] ; see Table 2 for details), nevertheless these study did not focus on the use of such devices for distal vessels MTB. Similarly to our study, Haussen et al. [12] reported results of a series of 8 patients treated for a distal occlusion with the Trevo XP ProVue Retriever 3-20 mm (Stryker Neurovascular, Fremont, California, USA) : the “Baby Trevo”. In this study, a total of 10 distal branches were addressed by MTB with the

“Baby Trevo”, all targeted vessels were recanalized. Follow-up MRI showed partial infarct for 5 out 10 patients and complete infarction for one. Two patients had parenchymal hematomas, one PH1 and one PH 2. The overall recanalization rate of this study is higher in comparison to our study (100% vs 78%). Nevertheless, the 24h follow-up dual-energy CT scan performed in patients of our series showed infarction within the territory vascularized by the artery targeted with the CM only in 4 out of 42 patients (19%). This is lower than the 50% of partial infarct and 10% of complete infract reported by Haussen et al. In our series, no massive hemorrhagic complications were observed after MTB in thin, distal branches. Minor hemorrhagic complications were observed in 2 out of 41 (4.9%) patients, in both cases patients were asymptomatic.

Post retrieval target vessel vasospasm was observed in 8 out of 41 (19.5%) cases. All of them promptly responded to intra-arterial nimodipine injection. Similarly, to « standard stent retriever » MTB [3] no vessel ruptures were observed in our study. In 4 cases (out of 41; 9.7%), the immediate post-procedural flat-panel CT scan showed of focal amount of extravascular contrast media located in the segment of the artery addressed with the CM (Figure 3). In all cases, the 24h dual-energy CT scan ruled out the presence of hemorrhagic transformation and showed the disappearance of the extravascular

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contrast media. Nevertheless, in 2 out of these 4 patients, CM stent retriever failed in removing the clot and the related vascular territory developed ischemia at 24h. In the remaining 2 cases, the device achieved successful recanalization resulting in the rescue on the relative brain parenchyma. Good neurological evolution at three months (mRS

≤2) was observed in 82,4% of patients treated with the CM, which compares similarly to the good neurological evolution rate reported by Kurre et al. [20] in a cohort of patients treated using another low profile stent retrievers, the “Baby Trevo”.

Conclusion

Our single center retrospective experience suggests that the CM stent retriever is safe and effective for the recanalization of small diameter distal branches feeding eloquent brain areas. Our study showed successful recanalizazion of such branches with CM stent retriever in 32 out of 41 patients; an overall recanalization rate of 78.0%. Although the results of our initial experience appear promising, they have to be compared with those of larger, prospective trials.

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References

1. Pierot L, Cognard C, Bracard S. The long way to positive trials for mechanical thrombectomy in acute ischemic stroke. J Neuroradiol 2015; 42:65-66.

2. Mendes Pereira V, Yilmaz H, Pellaton A, Slater LA, Krings T, Lovblad KO. Current status of mechanical thrombectomy for acute stroke treatment. J Neuroradiol 2015;

42:12-20.

3. Berkhemer OA, Fransen PS, Beumer D, et al. A randomized trial of intraarterial treatment for acute ischemic stroke. N Engl J Med 2015;372:11–20.

4. Campbell BC, Mitchell PJ, Kleinig TJ, et al. Endovascular therapy for ischemic stroke with perfusion-imaging selection. N Engl J Med 2015;372:1009–18.

5. Goyal M, Demchuk AM, Menon BK, et al. Randomized assessment of rapid endovascular treatment of ischemic stroke. N Engl J Med 2015; 372:1019–30.

6. Jovin, TG, Chamorro, A., Cobo, E, et al. Thrombectomy within 8 Hours after Symptom Onset in Ischemic Stroke. N Engl J Med 2015; 372:2296-2306.

7. 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; 372:2285–95.

8. Khoury NN, Darsaut TE, Ghostine J, et al. Endovascular thrombectomy and medical therapy versus medical therapy alone in acute stroke: A randomized care trial. J Neuroradiol 2017; 44:198-202.

9. Lovblad KO, Altrichter S, Mendes Pereira V, Vargas M, Marcos Gonzalez A, Haller S, Sztajzel R.Imaging of acute stroke: CT and/or MRI. J Neuroradiol 2015; 42:55-64.

10. Osborn AG. Diagnostic cerebral angiography. 2nd edn. Lippincott Williams & Wilkins, 1999.

11. Zaidat OO, Yoo AJ, Khatri P, et al. Recommendations on angiographic revascularization grading standards for acute ischemic stroke: a consensus statement.

Stroke 2013; 44:2650–2663.

12. Haussen, DC, Lima, A, Nogueira, RG. The Trevo XP 3×20 mm retriever (‘Baby Trevo’) for the treatment of distal intracranial occlusions. J Neurointerv Surg 2016; 8:295-99.

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13. Hacke W, Kaste M, Bluhmki E, et al. Thrombolysis with alteplase 3 to 4.5 hours after acute ischemic stroke. N Engl J Med 2008;359:1317–29.

14. 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; 6:260–4.

15. Deshaies, EM. Tri-axial system using the Solitaire-FR and Penumbra Aspiration Microcatheter for acute mechanical thrombectomy. J Clin Neurosci. 2013; 20:1303–5.

16. Rahme, R, Yeatts, SD, Abruzzo, TA, et al. Early reperfusion and clinical outcomes in patients with M2 occlusion: pooled analysis of the PROACT II, IMS, and IMS II studies.

J Neurosurg 2014; 121:1354-8.

17. Coutinho, JM, Liebeskind, DS, Slater, LA, et al. Mechanical Thrombectomy for Isolated M2 Occlusions: A Post Hoc Analysis of the STAR, SWIFT, and SWIFT PRIME Studies.

AJNR 2016 ; 37(4):667-72.

18. Cerejo, R, John, S, Bauer, A, et al. Emergent mechanical thrombectomy for acute stroke using the Mindframe Capture LP system: initial single-center experience. J Neurointerv Surg 2016; 8:1178-1180.

19. Kühn, AL, Wakhloo, AK, Lozano, JD, et al. Two-year single-center experience with the

‘Baby Trevo’ stent retriever for mechanical thrombectomy in acute ischemic stroke. J Neurointerv Surg 2017; 9:541–546.

20. Kurre, W, Aguilar-Pérez, M, Martinez-Moreno, R, et al. Stent Retriever Thrombectomy of Small Caliber Intracranial Vessels Using pREset LITE: Safety and Efficacy. Clin Neuroradiol 2017; 3:351-360.

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Table 1. Patients characteristics.

Characteristics

Number of patients 41

66 (18 – 87 years old) Demographic data

 Age (mean, range)

 Male gender (in %) 69%

12.1 ± 7.5 Stroke severity

 NIHSS score (mean ± SD)

 GCS (mean ± SD) 13.3 ± 3.5

28 6 2 4 Site of occlusion

 MCA M2

 MCA M3

 ACA A2

 PCA P2

 PCA P3

1

NIHSS: National Institutes of Health Stroke Scale, GCS: Glasgow Coma Scale, MCA: Middle Cerebral Artery, ACA: Anterior Cerebral Artery, PCA: Posterior Cerebral Artery.

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Table 2. Retrospective study of mechanical thrombectomy for intracranial arterial occlusion

Study Stent Analysis Segments N TICI >2b

Retrospective study using small diameter stent for proximal and distal intracranial occlusions Kühn et al. (2016) Baby Trevo Retrospective M1=7, M2=20, M3=1, A2=3,

V4=3, P1=1, P2=3

35 30/35

Kurre et al. (2015) pREset Retrospective TC=17, M1=31, M2=20, A2=2, PCA=5, BA=4

76 69/76

Cerejo et al. (2016) Mindframe Retrospective M1 = 2, M2 = 6, BA = 1 9 8/9 Retrospective study using small diameter stent for distal intracranial occlusions

Haussen et al. (2016) Baby Trevo Retrospective M3 = 5, A2 = 3, P2 = 1, P3 = 1 8 6/8

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Figure Legends

Figure 1. The Catch Mini, a nitinol, low profile, laser-cut stent retriever used for mechanical thrombectomy in distal intracranial occlusion.

Figure 2. Use of the Catch Mini device in a M2 occlusion. (A) Lateral subtracted view showing distal occlusion of M2 segment of the MCA (arrow); (B) Catch Mini stent retriever unsheathed across the occluded M2 branch (arrowhead); (C) Final DSA after MTB, revealing the complete reperfusion of the M2 branch targeted with the low profile stent retriever (asterix showing initial occlusion site).

Figure 3. (A) Immediate post-procedural xper-CT showing focal amount of extravascular contrast media along the segment of the artery addressed with the stent retriever. (B) 24h dual-energy CT scan showing the disappearance of the extravascular contrast media, and ruling out the presence of hemorrhagic transformation.

Figure 4. Use of the Catch Mini device in a P2 occlusion with (A) initial coronal DSA revealing occlusion of P2 segment of the PCA (arrow), followed by (B) Catch Mini device unsheathed in the occluded P2 branch (arrowhead), and (C) final subtracted view after MTB, showing the complete reperfusion of the P2 branch targeted (asterix indicating the initial occlusion site).

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