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New devices
Original research
Initial experience with a new distal intermediate and aspiration catheter in the treatment of acute ischemic stroke: clinical safety and efficacy
  1. Sibylle Stampfl1,
  2. Christoph Kabbasch2,
  3. Marguerite Müller3,
  4. Anastasios Mpotsaris2,
  5. Marc Brockmann3,
  6. Thomas Liebig2,
  7. Martin Wiesmann3,
  8. Martin Bendszus1,
  9. Markus A Möhlenbruch1
  1. 1Department of Neuroradiology, University Hospital Heidelberg, Heidelberg, Germany
  2. 2Department of Radiology and Neuroradiology, University Hospital of Cologne, Cologne, Germany
  3. 3Department of Diagnostic and Interventional Neuroradiology, RWTH Aachen University, Aachen, Germany
  1. Correspondence to Dr Sibylle Stampfl, Department of Neuroradiology, University Hospital Heidelberg, Im Neuenheimer Feld 400, Heidelberg 69120, Germany; sibylle.stampfl{at}med.uni-heidelberg.de

Abstract

Purpose To describe our initial experience with the novel 5 F SOFIA (Soft Torqueable catheter Optimized For Intracranial Access) intermediate and aspiration catheter for endovascular treatment of patients with acute ischemic stroke.

Methods A retrospective review was performed in three centers of prospectively collected data of all stroke patients who underwent endovascular therapy using the SOFIA catheter. Patients were enrolled between November 2013 and December 2014. The primary endpoint of the study was accessibility of the thrombus with the SOFIA catheter. As a secondary endpoint, the study assessed recanalization success (Thrombolysis In Cerebral Infarction (TICI) ≥2b). Clinical presentation on admission and discharge was also documented. In addition, catheter- and procedure-related complications (particularly thromboembolic complications) were recorded.

Results The SOFIA catheter was used in 115 acute stroke procedures. In 110 cases (96%) the catheter could be advanced to the occlusion site. After mechanical thrombectomy, successful recanalization (TICI ≥2b) was documented in 86.9%. There were no complications related to positioning of the catheter. Distal thrombus migration into a new vascular territory occurred in three patients following thrombectomy with a stent retriever (2.6%). The mean NIH Stroke Scale (NIHSS) score on admission was 16.8±6 and at discharge the mean NIHSS score was 8.2±7.7. Sixteen patients died.

Conclusions The SOFIA catheter is a safe and efficient catheter for endovascular stroke therapy.

  • Catheter
  • Stroke
  • Thrombectomy

https://doi.org/10.1136/neurintsurg-2015-011801

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    Introduction

    Endovascular therapy has become a standard procedure for the treatment of acute ischemic stroke.1–4 The technology of neuroendovascular devices has improved considerably since their introduction. Innovations and technological advances include thrombectomy devices and also catheter design and properties aimed at stable target vessel access—an essential requirement for every neurointervention.

    The newly designed SOFIA (Soft Torqueable catheter Optimized For Intracranial Access; MicroVention, Tustin, California, USA) catheter has recently been introduced. It can be used as an intermediate catheter as well as a single guiding catheter. It has a length of 125 cm, an outer diameter of 5 F, and an inner luminal diameter of 0.055 inch. The catheter tip has a straight configuration. The hybrid braid-coil design of the catheter is supposed to enable easy navigation into the distal vasculature, even in tortuous vessels, thus simplifying access to the thrombus. Furthermore, the softness of the distal catheter shaft was designed to facilitate atraumatic vessel access.

    We report the initial experiences of three centers using the SOFIA catheter in endovascular treatment of patients with acute ischemic stroke. Patients were enrolled between November 2013 and December 2014. The primary endpoint of the study was accessibility of the thrombus with the SOFIA catheter. As a secondary endpoint, the study assessed recanalization success (Thrombolysis In Cerebral Infarction (TICI) ≥2b). This was investigated only as a secondary endpoint as it depends more on the thrombectomy than on the SOFIA catheter itself.

    Methods

    Patients

    In three centers, prospectively collected data of all patients with acute stroke undergoing endovascular therapy using the SOFIA catheter as an intermediate aspiration catheter in combination with a stent retriever were retrospectively reviewed. Patients were enrolled between November 2013 and December 2014. On admission, all patients were examined by a neurologist for assessment of the initial NIH Stroke Scale (NIHSS) score. CT/CT angiography or MRI/MR angiography were performed to rule out hemorrhage or advanced ischemic parenchymal damage and to demonstrate main intracranial vessel occlusion. At discharge, the NIHSS score was assessed by a neurologist.

    Endovascular procedure

    Procedures were performed under general anesthesia or conscious sedation using a transfemoral access. During all the procedures the 5 F SOFIA catheter was used as intermediate catheter. An 8 F guiding catheter was placed in the common carotid artery of the affected side (or subclavian artery in the case of basilar artery occlusion). Subsequently, the SOFIA catheter was positioned in the internal carotid artery (ICA) or the vertebral artery. Angiographic runs were performed in standard projections. The SOFIA catheter was then advanced to the occlusion site, usually over a microcatheter. Depending on the operator’s preference, sole aspiration through the SOFIA catheter lumen was performed using a 20–60 mL syringe. Alternatively, for thrombectomy, the microcatheter was positioned across the occluded segment. Angiographic runs through the microcatheter lumen were performed to document the correct position of the microcatheter tip beyond the occluding thrombus. A stent retriever was then inserted through the microcatheter and carefully deployed by pulling back the microcatheter. Angiographic runs were performed to control for flow restoration. Immediately prior to thrombectomy, continuous manual aspiration through the SOFIA catheter lumen was applied using a 20–60 mL syringe. The deployed stent retriever and the microcatheter were pulled back simultaneously under continuous aspiration. In case of persistent occlusion or insufficient flow restoration, the device was reinserted and the maneuver was repeated.

    If patients presented with tandem occlusions, emergency percutaneous transluminal angioplasty (PTA) and/or emergency extracranial stent implantation was performed to gain access to the intracranial occlusion site. In these cases, medication with 500 mg aspirin intravenously and an initial dose of 600 mg clopidogrel via the gastric tube was administered.

    For angiographic image evaluation, angiographic images before and after the recanalization procedure were classified according to the TICI score.5 A post-interventional TICI score of ≥2b was classified as successful recanalization. Furthermore, for all procedures, the time to recanalization (defined as the time interval from the first diagnostic angiogram to the completion angiogram) was recorded.

    In addition, patients were assessed for the following parameters: site of occlusion, time interval from symptom onset to the first diagnostic angiogram, and procedure-related complications.

    Statistics

    Continuous data were collected in a database and are described as mean and SD. Statistical analysis was performed using GraphPad V.5.0 for OS X (GraphPad software, San Diego, California).

    Results

    Patients

    Overall, 115 patients (60 men and 55 women) of mean age 69.8 years (range 11–92 years) underwent endovascular stroke therapy using the SOFIA catheter. All patients presented with occlusions of main intracranial arteries (distal ICA, n=28; middle cerebral artery, n=67; basilar artery, n=17; anterior cerebral artery, n=2; posterior cerebral artery, n=1). On admission the mean NIHSS score was 16.8±6. Mean time from symptom onset to the first diagnostic angiogram was 194±87 min (median 176 min) in 94 patients (in the other patients, time of stroke onset was unknown). At discharge the mean NIHSS score was 8.2±7.7. Sixteen patients (13.9%) died.

    Endovascular procedure

    Mean time from the first diagnostic angiogram to the final recanalization result was 73.1±59.9 min. Regarding the primary endpoint of the study, advancement of the SOFIA catheter to the occlusion site was possible in a high percentage (96%). In only five cases was it not possible to navigate the catheter to the thrombus level due to extensive elongation of the proximal vessels. The secondary endpoint (successful recanalization TICI ≥2b) was achieved in 86.9%. In 17 patients, aspiration through the SOFIA catheter alone resulted in recanalization and, in another 3 patients, thrombectomy attempts had failed prior to successful sole aspiration. Overall, the following additional mechanical devices were used: Solitaire FR (Covidien, Dublin, Ireland); Trevo (Stryker, Arizona, USA); Penumbra System (Penumbra, California, USA); Embotrap (Neuravi, Galway, Ireland). In 10 patients additional emergency interventions in the cervical ICA were necessary due to high-grade stenosis (emergency stenting n=8, emergency PTA n=2). In two patients, stenting of a proximal vertebral artery stenosis was necessary to gain access to the occlusion site.

    Complications

    In six patients (5.2%) embolic complications with thrombus migration into a new vascular territory (n=3, 2.6%) or into the periphery of the same vascular territory (n=3, 2.6%) occurred during thrombectomy with a stent retriever. This affected the pericallosal artery (n=1), the ipsilateral A1 segment (n=1), the ipsilateral A2 segment (n=1), the P2 segment (n=1), the ipsilateral M3 segment (n=1), and the superior cerebellar artery and posterior inferior cerebellar artery origin (n=1).

    There was no intracranial or extracranial dissection related to positioning of the SOFIA catheter. In one patient, contrast extravasation was observed after the thrombectomy maneuver and subarachnoid hemorrhage as well as a small parenchymal hematoma were detected on the follow-up CT scan without clinical sequelae (improvement from NIHSS score of 17 on admission to NIHSS score of 6 at discharge). In seven patients (6.1%), symptomatic intracranial hemorrhage occurred within the infarction area. In one patient, cervical ICA dissection occurred after emergency PTA of a high-grade cervical ICA stenosis. However, the dissection caused no relevant flow restriction. In two patients, complications affected the puncture site (pseudoaneurysm, n=1; arteriovenous fistula, n=1). Both patients had to be transferred to the vascular surgery department for surgical repair.

    An example of a patient who underwent the procedure is shown in figures 1⇓⇓⇓–5.

    Figure 1
    Figure 1

    MRI of a patient in their 70s with symptom onset 5.5 h previously. Initial NIH Stroke Scale score was 16. MRI reveals a diffusion-weighted image lesion in the left basal ganglia.

    Figure 2
    Figure 2

    Angiogram (anteroposterior view) confirms a distal internal carotid artery occlusion on the left side.

    Figure 3
    Figure 3

    Advancement of the Soft Torqueable catheter Optimized For Intracranial Access (SOFIA) catheter (arrow indicates catheter tip) into the thrombus.

    Figure 4
    Figure 4

    (A, B) Final angiogram after three thrombectomy maneuvers using a stent retriever under continuous aspiration in lateral and anteroposterior views demonstrates complete recanalization corresponding to Thrombolysis In Cerebral Infarction (TICI) grade 3.

    Figure 5
    Figure 5

    CT scan 24 h after stroke onset shows an infarction area in the left basal ganglia corresponding to the diffusion-weighted image lesion on the stroke MRI. No infarction was noted in the peripheral middle cerebral artery territory. The patient`s clinical condition improved from a NIH Stroke Scale score of 16 to a score of 4.

    Discussion

    In patients with acute stroke, fast recanalization is crucial for a good clinical outcome.6 To achieve this goal, technological advances include thrombectomy devices and also new catheter technology. In this report we summarize the experience of three endovascular stroke centers with the novel 5 F SOFIA catheter.

    A stable access to the intracranial vasculature is a fundamental prerequisite for endovascular stroke therapy. This is of particular importance as stroke affects predominantly older patients with elongated and tortuous vessels. Therefore, the catheter tip should be soft to avoid any vessel injury during the catheter positioning and the catheter should be flexible to facilitate navigation through tortuous vessels. A flexible catheter with a distal catheter tip position provides more stability than a stiff catheter that cannot be advanced close to the intracranial target lesion.7 Furthermore, a distal catheter tip position helps to visualize and control the guide catheter even on a magnified field-of-view, and migration of the catheter toward the aortic arch due to increased friction during microcatheter advancement can be easily detected.

    In our study the primary endpoint was distal positioning of the SOFIA catheter tip at the occlusion site to achieve maximal stability and to support the thrombectomy maneuver by manual aspiration through the catheter lumen, which is supposed to prevent thrombus migration to a new vascular territory.8 Furthermore, the distal catheter position is helpful to rapidly reinsert the stent retriever in case of insufficient recanalization after the first thrombectomy attempt. In our series, in a high number of cases (96%) the catheter could be successfully navigated into the distal vasculature to the thrombus level, typically within the distal ICA or proximal middle cerebral artery. This offers the opportunity of direct thrombus aspiration with potentially very fast recanalization. This recanalization strategy seems especially promising in cases with a large thrombus burden, which would require a higher number of thrombectomy attempts. In our series it was shown that the SOFIA catheter easily reached a distal position allowing direct aspiration. However, a sole aspiration attempt was not an inclusion criterion for our study and was only performed depending on the operator's preference.

    Several reports on the direct aspiration first-pass technique using catheters other than the SOFIA catheter have recently been published. Kowoll et al9 and Turk et al10 investigated the efficacy of the Penumbra 5 MAX aspiration catheter (Penumbra, Alameda, California, USA). They advanced the aspiration catheter to the thrombus level and, subsequently, the catheter was withdrawn under continuous aspiration, which was applied either via a 20 or 60 mL syringe or via the Penumbra aspiration pump. Kowoll et al described a successful direct aspiration attempt in 56% of patients within a mean time to recanalization of only 30 min. However, the additional use of a stent retriever was necessary in a considerable number of patients to achieve a favourable recanalization result. Turk et al10 reported successful recanalization in 75% of patients and found that aspiration alone was significantly faster than thrombectomy, as reported in the literature.11 ,12

    Most recently, Jankowitz et al13 described their experience with a manual aspiration technique as first-line treatment that resulted in successful recanalization in 59% of patients. In the other cases, treatment with adjunctive devices was required. Aspiration was performed mostly with a Navien catheter (Covidien, Dublin, Ireland) between 0.072 inch and 0.058 inch. The authors concluded that the technique they used is feasible as a first step approach in most patients. Furthermore, they see a chance for cost reduction as large-bore catheters are usually less expensive than stent retriever devices. Although they used large-bore catheters, no intracranial dissection occurred.

    There are few reports in the literature on combined aspiration/device thrombectomy. Dumont et al8 described the technique of advancing a large-caliber aspiration catheter over the microcatheter to the occlusion site. The microcatheter was then advanced through the thrombus and a stent retriever was deployed. Subsequently, aspiration was started and thrombectomy was performed with ongoing aspiration. The authors concluded that recanalization time in patients with multiple thrombectomy attempts was reduced due to the distal catheter tip position, which facilitates repeated catheterization of the occluded vessel. Furthermore, distal embolization is limited because thrombus debris can be aspirated through the catheter lumen.

    More experience regarding the role of adjunctive thrombectomy has been gained in cardiology. In a meta-analysis of randomized trials in 2008, catheter thrombus aspiration during acute coronary interventions was considered to be beneficial in reducing the mortality compared with percutaneous coronary interventions alone.14

    Regarding the secondary endpoint (recanalization success), final recanalization corresponding to TICI ≥2b was reached in a very high percentage (86.9%), which is comparable to other endovascular stroke studies using stent retrievers.12 As the final recanalization result is much more strongly influenced by the thrombectomy maneuver than by the SOFIA catheter, it was assessed only as a secondary endpoint.

    There were no complications related to the positioning of the SOFIA catheter in our series. This is most likely due to the soft and flexible catheter shaft design. Overall, thromboembolic complications occurred in 5.2% during the thrombectomy device maneuver. However, thrombus migration into a new vascular territory occurred in only 2.6%. This rate is lower than previously reported (6% in the EXTEND-IA trial,15 8.6% in the MR Clean trial,16 and 11.4% in the study by Kurre et al17), which is probably due to the distal position of the SOFIA catheter tip preventing most thromboembolic events by manual aspiration of thrombus fragments.

    Limitations of the study

    The study has several potential limitations. Although the patients were enrolled prospectively, data analysis was performed retrospectively. Another limitation is the limited follow-up period which does not allow us to predict the long-term clinical outcome.

    Conclusion

    The primary endpoint of the study (navigation of the SOFIA catheter to the thrombus level) was achieved in a high percentage of cases (96%). Regarding the secondary endpoint (TICI ≥2b), high recanalization rates were achieved. There were no complications related to the SOFIA catheter. The rate of distal embolization into a new vascular territory was lower than in other reported studies of endovascular stroke. This finding is most likely due to manual aspiration of thrombus fragments through the catheter made possible by the close position of the catheter tip to the occlusion site. We therefore conclude that the novel 5 F SOFIA catheter is a safe and efficient catheter for endovascular stroke therapy.

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    View Abstract

    Footnotes

    • Contributors SS and MAM: study conception and design, interventions, acquisition of data, analysis and interpretation of data, drafting of the manuscript. CK, MM, AM and MB: interventions, acquisition of data, critical revision of the manuscript. TL, MW and MB: study conception and design, interventions, critical revision of the manuscript.

    • Competing interests AM: travel grant from Microvention, modest speaker honoraria from Penumbra. MB: research support from Terumo/Microvention. TL: other interests, non-related: Proctor and consult for Sequent Medical GmbH, Acandis, and Stryker. MW: has been working as a consultant for Stryker Neurovascular, Silk Road Medical, Philips; has received reimbursement for lectures or travel support from Boston Scientific, Bracco, Codman Neurovascular, Covidien, General Electric, Penumbra, Siemens, Stryker Neurovascular, Toshiba; has received grants for research projects or educational exhibits from Abbott, ab medica, Acandis, Bayer, Bracco, B Braun, Codman Neurovascular, Covidien, Dahlhausen, Microvention, Penumbra, Phenox, Philips, Siemens, St Jude, Stryker Neurovascular. MAM: speakers’ bureau or consultant: Codman, Microvention, Phenox.

    • Ethics approval Data were collected with approval of the ethics committees of the participating centers.

    • Patient consent Informed consent was obtained from the patients or their legal representatives.

    • Provenance and peer review Not commissioned; externally peer reviewed.