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Solitaire fr

Manufactured by Medtronic
Sourced in United States

The Solitaire FR is a medical device designed for use in a laboratory setting. It is a flexible aspiration catheter that is intended to assist in the removal of blood clots from blood vessels. The device features a self-expanding stent that can be used to capture and remove the clot. Its core function is to provide a tool for medical professionals to perform minimally invasive clot removal procedures.

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11 protocols using solitaire fr

1

Posterior Circulation Thrombectomy Techniques

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All patients were treated in the neuro-angiography suites under general anesthesia and were therefore sedated and intubated irrespective of their clinical status at admission. The devices used to achieve recanalization were at the discretion of the operator. Procedures were performed via the right common femoral route as standard using a 6F sheath. A brachial access route was used in patients if femoral access was not successful. Balloon guide catheters were not used as standard due to the location of the occlusions in the posterior circulation. The standard guide catheters included 6F Guider Softip (Boston Scientific) and 5F Envoy (Cordis). The microcatheters used in mechanical thrombectomy were either RapidTransit or Prowler Select Plus (Cordis, now Cerenovus); Trevo pro 18 MC (Stryker) or Velocity (Penumbra), The standard microguidewires were Synchro2 0.014” (Stryker) or pORTAL (phenox). Navien A+ 0.058” ID (Medtronic) and SOFIA Plus 0.070” ID (Microvention) were used for aspiration thrombectomies. Mechanical thrombectomy was performed with Solitaire FR (Medtronic) or pRESET (phenox). The earliest cases in the subset (2008–2009) used pCRC (phenox) or BONnet (phenox)devices.
The procedure time was defined as groin puncture time to final angiographic run. The date of treatment was recorded to test for any longitudinal effect on the clinical outcome.
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2

Endovascular Thrombectomy Techniques Evaluation

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All the patients underwent MT and were divided into different groups according to the first treatment with SR or CA. All endovascular treatments were completed by 2 interventional neuroradiologists with more than 5 years of interventional experience (BM. and DS). The first-line thrombectomy method was selected by the interventional neuroradiologists during the operation. The retrievers used in the study included Solitaire FR (Medtronic, Minneapolis, MN, United States), Solitaire AB (Medtronic, Minneapolis, MN, United States), and Trevo (Stryker Neurovascular, Salt Lake City, UT, United States). A large-bore aspiration catheter (Penumbra System Reperfusion Catheter ACE™ 60; Penumbra, CA, United States) or an intermediate catheter was used in CA. If the first-line method initially selected failed to achieve effective recanalization, another method would be used for rescue treatment. All the patients had completed CT and CTA examinations and signed informed consent before surgery.
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3

Endovascular Thrombectomy Techniques for LVO

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The following types of SR were used: Trevo (Stryker), Reco (Jiangsu Nico), Revive (Cordis) or Solitaire FR (Medtronic) device. The following ACs were used: Penumbra ACE60 reperfusion catheter (Penumbra), Catalyst 5/6 (Stryker), Sofia/Sofia plus (Microvention) or Navien 058/072 (Medtronic).16 (link)
Only trained and experienced neurointerventionists were allowed to perform MT for LVO in the ANGEL-ACT registry, and the first-line thrombectomy technique selection was as per the neurointerventionists’ preference.
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4

Large Vessel Occlusion Mechanical Thrombectomy

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In all patients, MT was performed under conscious sedation. The treatment devices used in MT were Solitaire FR (Medtronic, Minneapolis, MN, USA), Trevo ProVue (Stryker, Kalamazoo, MI, USA), EmboTrapII (Johnson and Johnson, New Brunswick, NJ, USA), Penumbra (Penumbra, Alameda, CA, USA), AXS Catalyst (Stryker), and Sofia Flow Plus (Terumo, Tokyo, Japan). Treating physicians selected the devices and singular (aspiration or stent retriever) or combined approaches.
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5

Mechanical Thrombectomy for Acute Ischemic Stroke

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On all patients, MT was performed under local anesthesia. As to access route, right transfemoral approach was adopted. As a rule, a balloon guiding catheter was used. Stent retrievers, such as a Solitaire FR (Medtronic, Minneapolis, MN, USA) and Trevo ProVue (Stryker, Kalamazoo, MI, USA), were selected as a first-line device, and a Penumbra System (Penumbra, Inc., Alameda, CA, USA) was combined with each stent retriever when recanalization was not achieved by a single pass or when necessary.
Recanalization was evaluated using the thrombolysis in cerebral infarction (TICI) grade.11) (link) Patients with TICI 2b or 3 were regarded as achieving effective recanalization.
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6

Thrombectomy Techniques in Acute Ischemic Stroke

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Anesthesiology team support was requested for all patients. The indication between conscious sedation or general anesthesia was defined on a case-by-case basis. The target mean blood pressure values were ≥100 mmHg if there was no rTPA infusion, and <180/105 mmHg if rTPA was performed. Intravenous heparin was infused (3000 IU bolus) for cases that did not receive rTPA. No patients required intra-arterial thrombolysis with rTPA.
Arterial accesses were obtained with 8 or 9F femoral sheaths. The access catheters used were conventional guides 7 or 8F, long sheaths Destination 7F (Terumo), NeuronMax 088 (Penumbra, Alameda, CA), balloon guide catheter (BGC) Cello 8 or 9F (Medtronic; Irvine, CA), or Merci 8F (Stryker; Kalamazoo, MI). The thrombectomy devices used were the stentriever Solitaire AB, Solitaire FR, Solitaire Platinum (Medtronic; Irvine, CA), Trevo Stentriever (Stryker; Kalamazoo, MI), or ACE aspiration system (Penumbra, Oakland, CA). Usually, at least three passes were made with the first-choice device before performing device association (stentriever and aspiration catheter). A total of ≥6 passes were performed before the procedure was deemed a failure in recanalization. For cases with occlusion in the proximal segment of the carotid artery, angioplasty with X-Act (Abbott Vascular) or Wallstent (Boston Scientific Target, Fremont, CA) was performed.
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7

Temporal Trends in Reperfusion Therapy

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For this study, reperfusion therapy referred to the use of IV rt-PA and/or EVT. IV rt-PA was defined as alteplase administered to patients with ischemic stroke. IV administration of alteplase was first approved in Japan in October 2005 for patients with acute ischemic stroke if it can be started within 3 hours of onset. The new labeled indication for IV rt-PA that extended the time window to 4.5 hours after onset was approved on 31 August 2012. In September 2012, the Japan Stroke Society released a statement indicating that the therapeutic time window for IV alteplase was extended to 4.5 hours after onset. Thus, we defined the period before and including August 2012 as the pre-extension period (29 months) and the period from September 2012 onward as the post-extension period (43 months).
EVT was defined as the use of percutaneous thrombectomy (Japanese medical service code: K178-4) or any type of thrombectomy catheter for ischemic stroke. Four types of percutaneous thrombectomy devices were approved in Japan from 2010 to 2014: the Merci Retrieval System (Concentric Medical Inc., Mountain View, CA) in 2010, Penumbra System (Penumbra Inc., Alameda, CA) in 2011, Solitaire FR (Covidien, Mansfield, MA) in 2014, and Trevo ProVue (Stryker Neurovascular, Fremont, CA) in 2014.
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8

Intravenous Thrombolysis and Mechanical Thrombectomy for Acute Ischemic Stroke

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If patients were eligible for intravenous thrombolysis, 0.9 mg/kg recombinant tissue-type fibrinogen activator (rt-PA) was administered before mechanical thrombectomy according to Chinese guidelines for the endovascular treatment of acute ischemic stroke (15 (link)). The mechanical thrombectomy procedure was performed by two interventional neuroradiologists with 10 years of practice in neurointerventions. The choice of STR or ADAPT was left to the discretion of the operator, usually based on the anatomical location of the thrombus obstruction, preoperative judgment of the etiology and pathogenesis, and the size of the thrombus. All patients were treated with local anesthesia, preferably through the right femoral artery, to establish access. A balloon guide catheter (BGC) was not used in all procedures due to limitations in available device conditions. The ADAPT and SRT techniques have been described previously (16 (link), 17 (link)). Patients received ADAPT using AXS Catalyst-6 (Stryker, USA) as front-line therapy. All stent retriever procedures were performed using the Solitaire FR (Covidien, USA). Meanwhile, intermediate catheters (AXS Catalyst-6) were routinely used. The operator could choose any necessary thrombectomy device and method to obtain an acceptable therapeutic effect if a successful recanalization could not be accomplished after three attempts using SRT or ADAPT.
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9

Stroke Thrombectomy Under Local Anesthesia

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All enrolled patients were selected according to stroke guidelines and underwent EVT under local anesthesia by two neurointerventionists with 10 years of experience. EVT was performed using stent retrievers [Solitaire AB (Covidien/ev3, Irvine, United States) and Solitaire FR (Covidien/ev3, Irvine, United States)] or react suction devices (Covidien/ev3, Irvine, United States). The physician performing the neurointervention regularly reported the number of stent retriever passes. If targeted arterial recanalisation failed, rescue therapies such as stent implantation, balloon angioplasty, intracatheter tirofiban administration or intra-arterial thrombolysis would be used.
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10

Intraarterial Treatment for Ischemic Stroke

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A neurointerventionalist (C.J.) performed intraarterial treatment (IAT) of all the cases on a biplane angiography machine (Integris Allura, Philips, the Netherlands). We used a 9 French balloon guiding catheter. In case of a tortuous cervical ICA, a second guiding catheter was used for the coaxial system. The primary device for IAT was a stent retriever (Solitaire FR; Covidien, Irvine, California; Trevo-XP; Stryker, Kalamazoo, MI, USA). Mechanical aspiration device, thrombolytics, or permanent stenting were also used at the discretion of operator. The reperfusion grading was measured by using modified treatment in cerebral infarction before and after IAT [13 (link)].
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