(C) The laser emission created a “pilot channel” (red circle), which enabled safe delivery and adequate positioning of a stent. In both cases, the patients underwent imaging that included CTA followed by diffusion/perfusion MRI. A man in his early 50s presented in the emergency department with left lower extremity swelling and increased pain and numbness. Objectives: In the acute ischemic stroke, endovascular devices have shown promising clinical results and are also likely to represent value for money, as several modeling studies have shown. Created with Sketch. Mortality rates associated with occlusions of the basilar artery, internal carotid artery (ICA) terminus, and M1 segment of the middle cerebral artery (MCA) are particularly high despite best available medical therapy.1–3 The paucity of safe and effective treatment strategies presents a profound unmet clinical need in the management of this prevalent and debilitating disease. Coupled with Lightning’s intelligent aspiration, the system is effective in thrombus retrieval and designed for blood loss reduction. The trackability and torqueability is bolstered by the hypotube that aims to support the removal of thrombus from large vessels with wall-adherent thrombus. Found insideThis book covers all aspects and the most vibrant topics of ischemic stroke research: from basic sciences to latest methods of clinical applications. Post-thrombectomy images showed complete resolution of the thrombus (Figure 2). Mechanical thrombectomy has been the mainstay therapy in large-vessel occlusion. The PS (Penumbra, Alameda, California) is a new mechanical thrombectomy device, specifically designed to remove the thrombus in acute ischemic stroke secondary to large-vessel thromboembolism. Jason Thomas Salsamendi, Issam Kably, in Atlas of Endovascular Venous Surgery (Second Edition), 2019. Then, Lightning 12 was taken first into the left PA where there was a smaller amount of thrombus that was cleared quickly. This comparison is shown in Figure 6-37, A and B. Kalpa De Silva, ... Peter O'Kane, in Cardiovascular Thrombus, 2018. Operators should exercise caution because large thrombus particles may be attached to the tip of the aspiration catheter even if there is no flow into the syringe. Figure 9.3. Venogram confirming complete thrombotic occlusion of the right iliac veins above the femoral vein (arrow) (B). Figure 1. Found inside – Page iiWritten in a style that is accessible to students and experienced practitioners alike, the book covers all the important recent advances that have reshaped the field in dramatic ways. A 14-F DrySeal sheath (Gore & Associates) was inserted into the main PA over a Supra Core guidewire (Abbott). Thrombectomy devices have shown benefit in terms of surrogate end points such as angiographic TIMI flow, infarct size reduction, ST-segment resolution, and biomarker analysis [52]. Levy, in Principles of Neurological Surgery (Third Edition), 2012, The Penumbra System (Penumbra, Inc., San Leandro, CA) is the second FDA-approved mechanical treatment for acute stroke. Subjects in the treatment group did experience a higher rate of symptomatic ICH (6.4% versus 0.6%); however, the investigators showed the benefits of the treatment outweighed the risk. The 5-F sheath was upsized to a 7-F Destination sheath (Terumo Interventional Systems) and an 0.018-inch crossing catheter and wire were used to cross the occluded segment into the popliteal artery. Recirculation mechanical thrombectomy devices use either high-speed rotation (>90,000 rpm) or retrograde fluid jets ranging from 1000 to 10,000 psi to generate hydrodynamic vortexes that ablate the thrombus. Using the circumferential sweep and the Separator 7 (SEP7; Penumbra, Inc.), wall-adherent thrombus was removed from the stent, allowing the catheter to work in a 360° fashion throughout the posterior tibial artery (Figure 1C). The catheter is soft, has an atraumatic design, and can be used with or without the wire. A 12-F sheath access was obtained in the right popliteal vein with the patient supine. The Lightning 12 aspiration catheter has excellent torqueability and a curved tip that allows for a 360° sweep. First, clot maceration and aspiration did not occur simultaneously, such that the resulting fragmented thrombus was aspirated through a guide catheter or sheath. In an attempt to reduce systemic adverse effects associated with the use of thrombolytic agents, focus has shifted to mechanical rather than pharmaceutical means of recanalizing the site of primary occlusion in subjects experiencing acute ischemic stroke. There are data to support thrombolytic therapy as well as some evidence that mechanical intervention can be clinically useful. Division of Vascular and Interventional Radiology Created with Sketch. Program Director Vascular Fellowship & Integrated Residency The Indigo System utilizes the Penumbra ENGINE ® aspiration source capable of delivering nearly pure, continuous vacuum (-29 inHg or 98.2 kPa) to our catheters, enabling thrombus removal in vessels of various sizes. Lightning 12 and SEP12 being used in the right PA (B). With percutaneous embolectomy, our practice has seen no issues of surgical site incisions, infections, or complicated fasciotomies. If residual thrombus remains after revascularization with aspiration, the thrombus removal ring is used to directly engage and remove the thrombus. The operator can focus on removing thrombus completely rather than being limited by the estimated blood loss (EBL). right-arrow Fig. A subject was considered enrolled into the study when the reperfusion catheter was deployed from the guide catheter to the site of occlusion. This subject died at 32 days postprocedure from worsening of pre-existing heart failure, unrelated to the procedure or the device. Karan Garg, MD The main entry criteria for the study were as follows: 1) clinical signs consistent with acute ischemic stroke; 2) age 18 years or older; 3) a score of TIMI 0 or 1 in a vessel accessible by the PS; and 4) presentation within 8 hours of stroke symptom onset (if presenting within 3 hours of stroke symptom onset, the subject must have been ineligible for or refractory to treatment with intravenous [IV] recombinant tissue plasminogen activation [rtPA]). Chief of Vascular Surgery CT demonstrating left iliac stent migration. There were no reports of adverse events during the procedures. Right lower extremity runoff angiogram demonstrating proximal long-segment occlusion of the SFA with distal reconstitution. Mechanical aspiration thrombectomy devices are dual-lumen catheters that are passed across the culprit lesion over a standard 0.014-inch guidewire. Stent placed to reduce irregularity from the ectasia (C). ACE™ devices (Penumbra, Inc.), reported >97% revas - cularization rates (thrombolysis in cerebral infarction [TICI] 2b/3), no instances of emboli to new territory (ENT), and groin puncture to revascularization times of 37 minutes or less.1 Another mechanical thrombectomy approach involves the use of a stent retriever, either in combi- … After this, we advanced the Lightning 7 into the AT, which had mid-vessel occlusion. The aspiration pump was then turned on to initiate revascularization. Complementary to the simple method described by Hakimelahi et al. Penumbra Embolectomy Aspiration System [INDIGO Aspiration System] Applicant. No tissue plasminogen activator (tPA) was given for the case. Figures 16.16 and 16.17 illustrate this principle. This early clinical experience suggests that the PS may have potential as treatment for acute ischemic stroke secondary to large-vessel thromboembolism and that further clinical testing is warranted. 60Co has a wide penumbra because the source size is large and the geometric penumbra is large. Scattered electrons and photons that have a higher effective energy have a corresponding higher lateral range of scatter outside the beam edge. With the inherent risks of using tPA, a mechanical thrombectomy option that can minimize the need to use tPA and may reduce intensive care unit (ICU) stay is ideal. The ischaemic penumbra can be visualized using a combination of perfusion-weighted and diffusion-weighted magnetic resonance imaging (PWI and DWI). Mortality for the 2 groups was equivalent (25% in the treatment arm versus 27% in the control arm), and the symptomatic ICH rate was 10% for the treatment group and 2% for the control group. Pharmacoeconomic evaluations in this field, however, have little impact on the procurement of these devices. Postintervention digital subtraction angiography demonstrated improvement of vascular flow in the bilateral PAs (Figure 3). In many instances, PE requires emergent interventions. 16.17. The Penumbra System enables physicians to use aspiration, which acts like a minimally invasive “vacuum” inside the artery, to remove stroke-causing blood clots from the brain safely and effectively. About Penumbra. Figure 9.2. We report our experience using the Penumbra system (PS; Penumbra, Alameda, California, USA) in a series of four patients with venous sinus thrombosis. Los Angeles, California Jay Mathews, MD, MS, FACC, FSCAI In terms of ease of use, Lightning 12 is easy to manipulate not only in the main PA but also distally into the lobar PA. Additionally, the audiovisual cues from Lightning and the thrombus detection algorithm are very helpful when removing thrombus from the PA. A significant amount of thrombus was removed throughout the left lower extremity (Figure 1E). Of the remaining 50% who presented within 3 hours, 6 were refractory to rtPA therapy, and 4 were not eligible for thrombolytic therapy. 9.3). Left popliteal venous access was obtained to correct the migrated stent (Figure 4). Found inside – Page iiAn invaluable contribution to the clinical literature, 12 Strokes: A Case-based Guide to Acute Ischemic Stroke Management will be of great interest to not only neurosurgeons and neurologists but other specialists, primary care providers, ... The International Commission on Radiation Units and Measurements (ICRU) recommends that penumbra be reported as the distance from the 80% point to the 20% point on a beam profile.9 They also recommend that the penumbra be reported at the depth of R85/2. Figure 3. When systemic anticoagulation therapy fails or is high risk, endovascular chemical thrombolysis or mechanical thrombectomy may be necessary. Acute lower extremity ischemia, defined as a rapidly developing or sudden decrease in perfusion to the lower extremity, often results in threatened limb viability. Found inside – Page iiThis is followed by a chapter about the most common complications of MT and post-procedural care of these patients. The last chapter covers different aspects of acute stroke care and MT in the developing world. 16.18. Pull-back thrombectomy and trapping devices engage and remove thrombus with a balloon catheter or basket, which retrieves the clot into a trapping device. Right lower extremity runoff angiography demonstrated patency of the right CFA and profunda femoris artery with proximal long-segment occlusion of the right SFA, including in-stent occlusion with distal reconstitution (Figure 1). It has also been used as inclusion criteria in successful phase II trials of desmoteplase, Desmoteplase in Acute Ischemic Stroke (DIAS) and Dose Escalation of Desmoteplase for Acute Ischemic Stroke (DEDAS) (Hacke et al., 2005; Furlan et al., 2006), in which patients were given the drug outside the 3-hour limit. The emergence of newer technologies such as Lightning 12 may be an example of where technology has outpaced clinical data. 17.2 and Video 17.2) The Penumbra System (Penumbra, Inc., San Leandro, CA) is the second FDA-approved mechanical treatment for acute stroke. Penumbra said today that it has received 510(k) clearance from the FDA for its Ace64 aspiration thrombectomy device, based on data from the … Found insideThis open access book offers an essential overview of brain, head and neck, and spine imaging. Over the last few years, there have been considerable advances in this area, driven by both clinical and technological developments. About the Penumbra System The fully integrated Penumbra System is designed specifically for mechanical thrombectomy. The Lightning 7 Intelligent Aspiration technology provides intraprocedural audiovisual cues to help detect thrombus, as well as dual-pressure sensors for real-time flow monitoring. In our experience, the Lightning 12 Intelligent Aspiration system has effectively removed clot with minimal complications. With the advent of endovascular therapy, a number of alternative mechanical approaches have shown promise in restoring blood flow in an occluded artery in acute ischemic stroke. Direct aspiration of the occluding thrombus is performed under fluoroscopic guidance by slowly advancing and withdrawing the catheter across (1) the lesion or (2) the area of greatest angiographic evidence of thrombus, while the catheter is attached to a syringe on fixed negative pressure. A large amount of thrombus was removed successfully (Figure 1D). Fig. This effect is seen as a degradation of the profile (more pronounced shoulder and toe). With the advent of endovascular therapy, a number of alternative mechanical approaches have shown promise in restoring blood flow in an occluded artery in acute ischemic stroke.5,6 The Penumbra System (PS; Penumbra, Alameda, Calif) is a new embolectomy device specifically designed to remove the thrombus in acute ischemic stroke secondary to large vessel thromboembolism. Amit Srivastava, MD, FACC, FABVM The catheter was advanced into the peroneal, and clot was quickly removed (Figure 2A). The ischemic penumbra is generally defined as severely hypoperfused brain tissue that may eventually be recruited into the infarct core, in the absence of timely reperfusion (Baron, 1999). UCLA Santa Monica Medical Center His right thigh and medial foot and ankle were cool to the touch on examination. Figure 1. It will be important to see in the future if case representations such as this are the norm and the paradigm shifts to more emergent intervention of intermediate to high-risk PE. Keval K. Patel, ... Tarek Helmy, in The Interventional Cardiac Catheterization Handbook (Fourth Edition), 2018. The catheter was then further advanced into the posterior tibial (PT) artery and completely cleared the vessel (not shown). The Penumbra System is a fully integrated system designed specifically for mechanical thrombectomy by aspiration that first received 510(k) clearance by the U.S. Food & Drug Administration in December 2007. Figure 1. There were no other reports of arterial perforation, dissection, or embolization of a previously uninvolved territory of the brain. All these catheters are available in both 6F and 7F sizes. Found inside – Page 449Suction Pump Thrombectomy The Penumbra Indigo (Penumbra, Alameda, CA) device is an aspiration thrombectomy catheter (Fig. 55.9) connected to a high-pressure Penumbra suction pump. It is available in a 6Fr or 8Fr catheter, ... Figure 2. We do not capture any email address. Cincinnati, Ohio Substantial evidence in the published literature suggests that early and safe revascularization of the primary occlusion correlates with improved clinical outcome.4 The probable basis for this correlation is that, although some brain tissue experiences near immediate and irreversible infarction during acute stroke, there remains a region of ischemic penumbra surrounding this area where at-risk tissue can be salvaged.4 Therefore, if timely revascularization can be effected and reperfusion established, then damage to the penumbral region could be reversed, resulting in a diminished neurologic deficit, reduced stroke-related mortality and morbidity, and improved clinical outcome. Catheter-directed therapy can be performed using catheter-directed thrombolysis or endovascular thrombus aspiration. Lakeland, Florida Manatee Memorial Hospital After obtaining signed informed consent, all of the eligible subjects were evaluated for neurologic and functional status, and an angiographic assessment of the suspected vascular occlusion was obtained. Among the 8 cases of hemorrhage, 1 was thought to have been caused by the device (see above description of intraprocedural subarachnoid hemorrhage). Among the 20 subjects, 8 (40%) were women. Throughout the procedure, the Lightning device flashed yellow without any clicking, indicating thrombus was most likely occluding the catheter. Once the left side was cleared, access was gained in the left CFA with the same sheath to clear the right popliteal. 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