Sponsore Penumbra, Inc. Venous And Arterial Thrombus Removal With The .


FEATURED TECHNOLOGYINDIGO SYSTEMSponsored by Penumbra, Inc.Venous and Arterial ThrombusRemoval With the Indigo System:Pulmonary Embolism IndicationWITH ROBERT A. LOOKSTEIN, MD, MHCDL, FSIR, FAHA, FSVM; JOSÉ A. GUIROLA, MD,P h D, EBIR; MIGUEL A. de GREGORIO, P h D, EBIR, FSIR, FCIRSE; ANDREW GEMMELL, MBC h B,FRCR; JUAN JOSÉ CIAMPI-DOPAZO, MD, EBIR; PEDRO PARDO MORENO, MD, P h D;GONZALO RUIZ VILLAVERDE, MD, P h D; ABDULRAHMAN ALVI, MRCS, FRCR;FRANCESCO INTRIERI, MD; VINCENZO MOLINARI, MD; AND HEIKO WENDORFF, MD, FEBVSRobert A. Lookstein, MD, MHCDL, FSIR,FAHA, FSVMProfessor of Radiology and SurgeryVice Chair, Interventional Services Mount Sinai Health SystemNew York, New YorkThe acute pulmonary embolism (PE) treatment paradigm is evolving to treat patients who have emergentsymptoms and are unable to tolerate long thromboaspiration procedures. Now, the goal with thrombus removalin PE is to safely and effectively remove thrombus andpotentially reduce treatment time. Thrombolysis is nota universal option for all patient groups, especially if thepatient has an absolute or relative contraindication to afibrinolytic agent. Large-bore embolectomy, when pairedwith a syringe, has led to variable results, with questionsregarding the ideal technique to achieve a uniform state ofvacuum aspiration.1 The catheters used to aspirate shouldideally be atraumatic and easily deliverable to be able toaccess and establish flow through the lobar branches ofthe pulmonary artery (PA), reducing right heart strain andPA pressure (PAP). Sustained aspiration from the IndigoSystem provides physicians with an alternative option forpatients who are not ideal candidates for lytics or openembolectomy and provides a frontline therapy optionthat still preserves the use of any adjunctive therapy.The Indigo Aspiration System provides a treatmentoption that is CE Marked. The sustained aspiration from thePenumbra ENGINE provides constant uninterrupted fullvacuum aspiration throughout the procedure, addressingthe constraints of syringe-based large-bore embolectomy,which include vacuum dropoff from the syringe fillingwith fluid. The CAT8’s large lumen can allow for efficient22 INSERT TO ENDOVASCULAR TODAY EUROPE 2020 VOLUME 8, NO. 5clot removal, which can be enhanced when paired withmechanical separation from the SEP8. Engineered to betrackable, deliverable, and torqueable, the CAT8’s atraumatic tip can navigate the lobar anatomy of the PA to helpestablish inflow and outflow, helping to restore patientvitals to normal.The EXTRACT-PE study completed in 2019 evaluated the safety and efficacy of the Indigo AspirationSystem in the management of submassive PE. The IndigoSystem Catheter CAT8 was used across 22 sites in theUnited States in patients with submassive PE who did notreceive thrombolytics (98.3%), with a right ventricular/leftventricular (RV/LV) ratio reduction of 27.3% at 48 hours.The on-table PA pressures were statistically reduced, andthe median device time was 37 minutes. This proceduretime has been embraced by countless interventionalists concerned about prolonged case times with otherthromboaspiration technologies. The major adverse eventrate in EXTRACT-PE was 1.7%, and patients had a medianintensive care unit stay of 1 day. The EXTRACT-PE trialdemonstrated that the Indigo System can provide immediate mechanical relief using sustained aspiration. As PEtreatment options continue to grow, the EXTRACT-PEresults with the Indigo System serve as a promising dataset in helping move the PE landscape forward.This new thromboaspiration technology allows for clotremoval and potential reduction in right heart and PA pressure. It is low-profile and deliverable to all vascular territoriesin the pulmonary circulation. It is a welcome addition toour existing endovascular technologies for the treatment ofacute PE.1. Giri J, Sista A, Weinberg I, et al. Interventional therapies for acute pulmonary embolism: current status andprinciples for the development of novel evidence: a scientific statement from the American Heart Association.Circulation. 2019;140:e774-e801. doi: 10.1161/CIR.0000000000000707

FEATURED TECHNOLOGYINDIGO SYSTEMSponsored by Penumbra, Inc.HIGH-RISK PULMONARY EMBOLISMCONTRAINDICATED FOR FIBRINOLYSISTREATED WITH INDIGO SYSTEMJosé A. Guirola, MD, PhD, EBIRInterventional RadiologistHospital Clínico Universitario “Lozano Blesa”Zaragoza, Spainjoseandresguirola@gmail.com; @guiro iradMiguel A. de Gregorio, PhD, EBIR, FSIR,FCIRSEInterventional RadiologistCatedrático de Universidad de ZaragozaZaragoza, Spainmgregori@unizar.es; @madga gitmiPATIENT PRESENTATIONA 73-year-old woman developed swelling of both legsas well as difficulty breathing. She was admitted to theemergency department with a pulse oximetry of 85%,a FiO2 of 21%, and a blood pressure of 90/60 mm Hg.She had a history of head injury with intraparenchymal cerebral, subdural, and subarachnoid hemorrhage30 days prior to the hospital consultation.CTA was performed and showed thrombus in theright and left main PAs with a Qanadli score of 70% to80%, RV/LV ratio 0.9, and moderate pericardial effusion (Figure 1). She also had elevated high-sensitivitytroponin T and a transthoracic echocardiogram showedRV dysfunction with a tricuspid annular plane systolicexcursion (TAPSE) 16 mm. Compression ultrasounddemonstrated a proximal vein thrombosis in the left andright femoral veins.Catheter-directed thrombolysis and systemic fibrinolysis were contraindicated. A nearby center with aspecialized team for surgical thrombectomy was notavailable. Mechanical thrombectomy using the IndigoABABFigure 1. Thrombus in the main right PA (white arrow) (A).RV/LV ratio 0.9; moderate pericardial effusion (black star) (B).System (Penumbra, Inc.) was established as the treatment of choice.INTERVENTIONThe patient was monitored by an anesthesiologistwithout performing tracheal intubation or the administration of intravenous sedation. Right jugular access witha 10-F Super Sheath XL (Boston Scientific Corporation)was used, and a Günther Tulip inferior vena cava (IVC)filter (Cook Medical) was placed infrarenal before thepulmonary procedure to prevent additional thromboticembolization. A 6-F angled-pigtail catheter (Cordis,a Cardinal Health company) was introduced in the mainPA, and PAP was measured at 43/16 mm Hg (mean,27 mm Hg). A 260-cm stiff guidewire was insertedinto the pigtail catheter and exchanged for the IndigoSystem’s Aspiration Catheter CAT8 XTORQ. The CAT8catheter was delivered into the highest thrombus burden in the patient’s right PA. Power aspiration using theCAT8 and Separator 8 allowed thrombus removal andcreated the first channels for flow restoration. Aspirationof thrombus from distal to proximal was finalized afterhemodynamic stability was achieved and the decreasein systolic PAP was 10 mm Hg. The final PAP was32/14 mm Hg (mean, 17 mm Hg) (Figures 2 and 3).The patient was admitted to the intensive care unitfor monitoring and remained there for 7 days because ofuncontrolled atrial fibrillation and urinary infection. Thepatient remained hemodynamically stable and a nasalCFigure 2. Thrombus in the main right PA (white arrow) (A). CAT8 and SEP8 (white arrows) in the right superior trunk artery (B).Angiography postthrombectomy shows recanalization (white arrow) of the superior trunk and inferior PA (C).2020 VOLUME 8, NO. 5 INSERT TO ENDOVASCULAR TODAY EUROPE 23

FEATURED TECHNOLOGYINDIGO SYSTEMSponsored by Penumbra, Inc.Figure 3. Partial thrombus aspirated with CAT8.Figure 4. Pulmonary angiography control after 1 monthscheduled for IVC filter retrieval.cannula was used for oxygen therapy after thrombectomy was performed.The patient was scheduled for IVC filter retrieval1 month after PE thrombectomy. Final PAP was25/4 mm Hg (mean, 14 mm Hg); pulmonary angiographyshowed complete recanalization of both PAs (Figure 4).or mechanical thrombectomy.1,2 An IVC filter wasimplanted to prevent the migration of more thrombithat can worsen the patient’s status. The Indigo SystemCAT8 is an effective, safe, and simple device that allowsthe aspiration of emboli and thrombi in the PAs. CAT8paired with continuous power aspiration delivered byPenumbra ENGINE can remove thrombus, even in largediameter vessels as demonstrated in this case. In addition, SEP8 can be utilized to aid in thrombus removal byhelping clear thrombus from the catheter tip.DISCUSSIONThe typical treatment option for high-risk PE is systemic fibrinolysis with urokinase or recombinant tissueplasminogen activator (tPA). In this case, both fibrinolysis and anticoagulation with unfractionated heparinor low-molecular-weight heparin were contraindicatedbecause of the history of intracerebral hemorrhage30 days prior to presentation. The only therapeuticoptions for this patient were surgical thrombectomyINDIGO SYSTEM FOR ILIOFEMORALPOPLITEAL VENOUS THROMBOSISAndrew Gemmell, MBChB, FRCRConsultant RadiologistRoyal Devon and Exeter HospitalExeter, United Kingdomandrew.gemmell@nhs.netPATIENT PRESENTATIONA 66-year-old woman presented with a 1-day historyof acute-onset left leg swelling. Contrast-enhanced CTrevealed thrombosis of the left common and externaliliac veins extending into the left femoral veins. Thedistal extent of thrombus was not established. The ori24 INSERT TO ENDOVASCULAR TODAY EUROPE 2020 VOLUME 8, NO. 51. De Gregorio MA, Guirola JA, Kuo WT, et al. Catheter-directed aspiration thrombectomy and low-dose thrombolysis for patients with acute unstable pulmonary embolism: prospective outcomes from a PE registry. Int J Cardiol.2019;287:106-110. doi: 10.1016/j.ijcard.2019.02.0612. Ciampi-Dopazo JJ, Romeu-Prieto JM, Sánchez-Casado M, et al. Aspiration thrombectomy for treatment of acutemassive and submassive pulmonary embolism: initial single-center prospective experience. J Vasc Interv Radiol.2018;29:101-106. doi: 10.1016/j.jvir.2017.08.010gin of the left common iliac vein appeared compressedfrom the right common iliac artery, suggesting MayThurner syndrome. The medical team referred the caseto interventional radiology.Due to the acute presentation and severity of the leftleg swelling in an otherwise fit and very active patient,mechanical thrombectomy with the Indigo System wasused.INTERVENTIONAn infrarenal IVC filter (Celect Platinum, Cook Medical)was placed initially accessing the right internal jugularvein with a 9-F sheath (Brite Tip; Cordis, a Cardinal Healthcompany). A hydrophilic guidewire passed easily throughthe left iliac thrombus. Venography confirmed thrombosisextending to the mid femoral vein level (Figure 1).

FEATURED TECHNOLOGYINDIGO SYSTEMSponsored by Penumbra, Inc.Figure 1. Venogramdemonstrating anextensive iliofemoral thrombosis.Figure 2. Parts of thrombus removed,which wrapped around the SEP8.Thrombus was laced with 10 mg of tPA administeredthrough a multipurpose catheter (Glidecath, TerumoInterventional Systems) and left for 15 minutes. Theorigin of the left common iliac vein was then dilatedusing a 10-mm balloon (Advance, Cook Medical);a marked degree of balloon wasting was observed.The 115-cm CAT8 XTORQ aspiration catheter easilytracked into the thrombus. Under power aspiration,the CAT8 was slowly advanced distally into the common iliac vein in combination with SEP8 allowing forthrombus removal in a single passage. By cycling theSeparator back and forth under aspiration, the thrombus was removed (Figure 2).Repeat venography revealed a good result with a verysmall amount of residual thrombus (Figure 3).Venous access was then secured using a 6-F sheath(Avanti ; Cordis, a Cardinal Health company) viathe left popliteal vein. Thrombolysis was continuedovernight using tPA and a heparin infusion. Repeatvenography the following day revealed a moderatedegree of residual thrombus involving femoral and iliacveins; however, the veins were patent. A 10-F Brite Tipsheath was placed in the left common femoral vein toplace an 8-cm X 16-mm sinus-Obliquus stent (optimedMedizinische Instrumente GmbH) to cover the leftcommon iliac stenosis. A final venogram confirmedgood venous flow (Figure 4).Figure 3. Following use ofthe Indigo System, a venoFigure 4. Final venogram congram showed patency offirming good venous outflow.the iliofemoral segmentwith a small amount ofresidual thrombus.PATIENT OUTCOME AND FOLLOW-UPA mild degree of left leg swelling persisted the day aftertreatment, although this had improved. The pain had alsoreduced. The patient was discharged the following daywithout complication with continued oral rivaroxaban.DISCUSSIONEndovascular management is currently recommendedfor acute presentations of thrombotic May-Thurnersyndrome with moderate to severe symptoms.1 Weprefer to place a temporary IVC filter prior to intervention to protect against PE, although the British Societyfor Haematology guidelines state thrombolysis is not anindication for filter insertion.2The Indigo System was well tolerated and allowed forrestoration of flow. The Separator helped evacuate thethrombus effectively by limiting catheter clogging, whichhelped to reduce the procedure time. The appropriatelysized venous stent was not available at the time of aspiration. Had this been available, venous stenting couldhave been completed immediately after clot aspirationto help avoid the risks of overnight catheter thrombolysis and a second procedure.1. Patel NH, Stookey KR, Ketcham DB, Cragg AH. Endovascular management of acute extensive iliofemoral DVT causedby May-Thurner syndrome. J Vasc Interv Radiol. 2000;11:1297-1302. doi: 10.1016/s1051-0443(07)61304-92. Baglin TP, Brush J, Streiff M. Guidelines on use of vena cava filters. Br J Haematol. 2006;134:590-595.doi: 10.1111/j.1365-2141.2006.06226.x2020 VOLUME 8, NO. 5 INSERT TO ENDOVASCULAR TODAY EUROPE 25

FEATURED TECHNOLOGYINDIGO SYSTEMSponsored by Penumbra, Inc.ACUTE UPPER LIMB THROMBOSIS TREATEDWITH INDIGO SYSTEMJuan José Ciampi-Dopazo, MD, EBIRInterventional Radiology UnitHospital Virgen de las Nieves Granada, Spainjuanciampi@hotmail.comPedro Pardo Moreno, MD, PhDInterventional Radiology UnitHospital Virgen de las NievesGranada, Spainpedropardomoreno@gmail.comGonzalo Ruiz Villaverde, MD, PhDInterventional Radiology UnitHospital Virgen de las Nieves Granada, Spainlalousso@hotmail.com(Figure 1). An 85-cm CAT8 XTORQ85 aspiration catheter was advanced over an 0.035-inch guidewire facingthe occlusion. Aspiration was initiated and CAT8 wasused with the SEP8 to facilitate thrombus engagementinto the canister. After only 10 minutes of a few passeswith power aspiration, a 90% thrombotic load reductionwas achieved (Figure 2). Subsequent venography showedunderlying focal stenosis in the infraclavicular subclavianvein segment, which could be secondary to thoracicoperculum syndrome. Simple angioplasty was performedusing an 8-mm X 4-cm balloon catheter (Mustang,Boston Scientific Corporation), with significant stenosisresolution (Figure 3A and 3B).PATIENT FOLLOW-UP AND DISCHARGEA control venogram showed minimal residual clot(Figure 4). The procedure lasted approximately 45 minutes. The patient was asymptomatic at 24 hours anddischarged with low-molecular-weight heparin for3 months. The patient’s thoracic operculum syndromewill be followed on an outpatient basis to plan surgery.PATIENT PRESENTATIONDISCUSSIONA woman in her 50s with no previous diseases preThe Indigo System can be considered a safe andsented with an acute left arm and shoulder edema andefficient instrument for the removal of acute venouspurple skin coloration after sudden physical exercise. Dopplerultrasound was performed,identifying a complete thrombosis of the left axillary and subclavian veins.Therapeutic anticoagulationtreatment with low-molecularweight heparin was initiated,and 12 hours later, the patientwas sent for treatment in thevascular and interventionalFigure 1. An intraoperative venogramFigure 2. The first result after power aspiradiology unit.showed occlusion of the subclavian vein.INTERVENTIONThe procedure was performed under conscious sedation and a total volume of5,000 IU heparin was administrated intravenously. Retrogradevascular access to the venoussegment was performed underultrasound guidance usingan 8-F short sheath in the leftbrachial vein. Venographyconfirmed thrombus in thesubclavian and axillary veinsAration using CAT8/SEP8 showed successful thrombus removal.BFigure 3. Placement of the 8-mm X 4-cm Mustang balloon catheter for angioplasty ofstenosis in the infraclavicular subclavian vein segment.26 INSERT TO ENDOVASCULAR TODAY EUROPE 2020 VOLUME 8, NO. 5

FEATURED TECHNOLOGYINDIGO SYSTEMSponsored by Penumbra, Inc.thrombosis of the upper limb. In cases of heavy clotburden, its main advantage includes the use of continuous power aspiration through large lumen cathetersto help with thrombotic load removal while helpingto reduce hemolysis complications. In addition, it mayreduce the risk of bleeding complications by potentiallylimiting or diminishing the need of fibrinolytic agents,which can help avoid the need for intensive care tohelp shorten the length of hospital stay.1Figure 4. The final venogram demonstrated almost completeremoval of thrombus in the subclavian and axillary veins.PORTAL VEIN THROMBOSIS AFTERLIVER TRANSPLANT TREATED WITHINDIGO SYSTEM AND THROMBOLYSISAbdulRahman Alvi, MRCS, FRCRConsultant Vascular and InterventionalRadiologist King Abdul Aziz Medical City, Ministry ofNational Guard Health AffairsRiyadh, Saudi Arabiaarjalvi@gmail.com; @DRARJA VIRPATIENT PRESENTATIONA 71-year-old man presented to a local hospital withabdominal pain, vomiting, and weight loss. He had aliver transplant for hepatitis C cirrhosis in 2006. His initial blood tests, including white blood cell count, liverfunction tests, and serum lactate, were normal. A dualphase CT of the liver demonstrated extensive portalvein thrombosis involving the intrahepatic portal veinbranches and extending into the superior mesentericvein (SMV) and splenic vein. Despite mesenteric fatstranding, there were no signs of bowel ischemia. Lowmolecular-weight heparin was started, and the patientwas subsequently transferred to our tertiary liver transplant center for further management.Despite a prolonged lytic drip, a second CT scanshowed no change in the distribution and volume ofportal venous-mesenteric thrombosis. Endovasculartreatment options included either a transjugular intrahepatic portosystemic shunt (TIPS) or percutaneous transsplenic/transhepatic thrombectomy and thrombolysis.A TIPS procedure was undertaken given the extensiveintrahepatic portal vein thrombus and the need toestablish satisfactory outflow.1. Vemuri C, Payam S, Benarroch-Gampel J, et al. Diagnosis and treatment of effort-induced thrombosis of the axillary subclavian vein due to venous thoracic outlet syndrome. J Vasc Surg Venous Lymphat Disord. 2016;4:485-500.doi: 10.1016/j.jvsv.2016.01.004ABCFigure 1. Initial portal venogram showed extensive portalvein (A, B) and SMV (C) thrombus.ABFigure 2. Significant residual thrombus in portal vein afterTIPS implantation (A). Improved flow across the TIPS afterdeployment of 12-mm Venovo stent into the thrombosedmain portal vein (B).INTERVENTIONThe thrombosed portal vein was accessed from theright hepatic vein under ultrasound guidance, and initialvenography correlated with the CT findings of the extensive portal and SMV thrombosis (Figure 1). A 10-mm (7 2 cm) Viatorr TIPS endoprosthesis (Gore & Associates)2020 VOLUME 8, NO. 5 INSERT TO ENDOVASCULAR TODAY EUROPE 27

FEATURED TECHNOLOGYINDIGO SYSTEMSponsored by Penumbra, Inc.was implantedbetween the rightportal vein andright hepatic vein.Extensive residualthrombus remained,therefore, a 12-mmVenovo venous stent(BD Interventional)was placed into theportal vein, resulting in improvedflow; however, significant thrombusremained (Figure 2).Figure 3. Extensive residualConsequently, an overSMV thrombus after 24 hours ofnight lytic drip wascatheter-directed thrombolysis.attempted.After 24 hours of lysis, repeat venography demonstrated suboptimal results with residual thrombus (Figure 3).Mechanical thrombectomy of the portal vein, SMV, andits tributaries was undertaken using the Indigo System.The CAT8 XTORQ aspiration catheter was deliveredthrough a transjugular approach via the 10-F sheathto the thrombus. Aspiration was commenced allowingfor gentle removal of the high thrombus burden at themain portal vein using the CAT8 in conjunction withSEP8. An Indigo CAT6 catheter was telescoped throughthe CAT8 XTORQ to facilitate thrombus removal in thesmaller vessel of the SMV and deep into its tributariesto improve the inflow to the portal vein (Figure 4). Thepostprocedure venogram showed restoration of flowthrough the TIPS, portal vein, and the main trunk of theSMV and its tributaries (Figure 5).Liver Doppler ultrasound performed on day 3 afterTIPS demonstrated patent TIPS and portal vein withresidual nonocclusive thrombus within the SMV andsplenic vein. Systemic anticoagulation (apixaban) wascommenced on discharge. CT scan at 2 months anda TIPS surveillance angiogram (Figure 6) at 3 monthsshowed a patent portal vein, SMV, and TIPS stent with aportocaval pressure gradient of 7 mm Hg.DISCUSSIONThe incidence of portal vein thrombosis after liver transplantation is uncommon but can cause significant mortalityand morbidity. TIPS provides access into the portal veinwith a theoretically lower bleeding risk because of a reducedrisk of liver capsule transgression as well as increased portalvein flow, which helps dissolve residual thrombus.This case illustrates the versatility of the Indigo System,with its wide range of highly trackable and atraumatic28 INSERT TO ENDOVASCULAR TODAY EUROPE 2020 VOLUME 8, NO. 5ABFigure 4. Power aspiration with CAT8/SEP8 the SMV and portal vein (A). Telescoping of the CAT6 through CAT8 (B).Figure 5. Postthrombectomy venogram demonstrated patent TIPS, portal vein, main trunk of the SMV, as well aspartial recanalization of some of its tributaries.Figure 6. TIPS surveillance angiogram at 3 months showed apatent TIPS. The portocaval pressure gradient was 7 mm Hg.

FEATURED TECHNOLOGYINDIGO SYSTEMSponsored by Penumbra, Inc.catheters facilitating thrombectomy deep within themesenteric venous system. The powerful aspirationpump generates a sustained vacuum that facilitatesthrombus extraction in cases with significant thrombusACUTE ISCHEMIA OF THE LEFT UPPER LIMBTREATED WITH INDIGO SYSTEMFrancesco Intrieri, MDChief of Vascular SurgeryOspedale Annunziata–AO CosenzaCosenza, Italyf.intrieri@alice.it; francesco.intrieri@pec.itVincenzo Molinari, MDVascular SurgeryOspedale Annunziata–AO CosenzaCosenza, Italyvincenzomolinari79@gmail.comPATIENT PRESENTATIONA 70-year-old man presented in the emergencydepartment with acute ischemia of the left hand.He had a history of coronary artery disease, cardiacarrhythmia, chronic obstructive pulmonary disease,and chronic lymphatic leukemia and was undergoingantiplatelet therapy. CTA showed evidence of parietalthrombosis in the subclavian and axillary arteries thatlooked slightly dilated. Furthermore, the distal part ofFigure 2. CAT6 and SEP6 tracked tothe distal radial artery.burden. The Indigo System can potentially reduce thevolume of fibrinolytic agents administered, which mayhelp lowering the risk of hemorrhage in these patients.the radial artery,ulnar artery, and thesuperficial and deeppalmar arch werethrombosed. In theclinical examination,the hand lookedcyanotic and ischemic with a deficit inmobility and sensitivity and, therefore,was scheduled forrevascularizationwith thrombolysis.The cause of theFigure 1. Preprocedural angiogramischemic hand wasshowed total occlusion of the radialan embolic eventartery after thrombolysis.from atrial fibrillation. An attempt ofintra-arterial thrombolysis was unsuccessful (heparinand urokinase infusion).INTERVENTIONPercutaneous access was performed throughthe right femoral artery with a 6-F, 90-cm sheathFigure 3. Postprocedural angiogramafter CAT6 and CAT3 showing successfulrecanalization.Figure 4. Complete restoration of flowafter Indigo System and thrombolysis.2020 VOLUME 8, NO. 5 INSERT TO ENDOVASCULAR TODAY EUROPE 29

FEATURED TECHNOLOGYINDIGO SYSTEMSponsored by Penumbra, Inc.(Destination, Terumo Interventional Systems) up tothe left axillary artery, and angiography was performed.Despite the thrombolysis treatment, the radial arterywas occluded distally with no runoff into the palmar orinterdigital branches (Figure 1).A 135-cm Indigo CAT6 aspiration catheter was inserted through the Tuohy-Borst adapter of the 6-F sheath. Iteasily tracked over an 0.018-inch Command ST (Abbott)guidewire into the radial artery. Mechanical thrombectomy using power aspiration was performed. CAT6and SEP6 were used to engage the emboli occludingthe distal radial artery (Figure 2). Partial thrombectomywas achieved with CAT6, and a 150-cm CAT3 was telescoped through the CAT6 to reach the superficial anddeep palmar arch, resulting in complete revascularization. The patient’s clinical conditions improved, showingparenchymal enhancement at the level of the radial andpalmar artery as well as the interdigital branches. Controlangiography was performed (Figure 3).THROMBOSIS OF THE MAIN BODY AND RIGHTLIMB OF AN AORTIC STENT GRAFT TREATEDWITH INDIGO SYSTEMHeiko Wendorff, MD, FEBVSSenior Physician Vascular Surgery Specialist, EndovascularSurgeon and Specialist, PhlebologyClinic and Polyclinic for Vascular andEndovascular SurgeryTechnical University of MunichMunich, Germanyheiko.wendorff@mri.tum.dePATIENT PRESENTATIONA 79-year-old man underwent total endovascularaneurysm repair (EVAR) of his abdominal aortic aneurysm in 2015. The patient’s medical history includedarterial hypertension and hyperlipidemia. In 2019,he presented with bilateral iliac aneurysms. Iliac sidebranch (ISB) grafts were planned on both sides tomaintain blood flow into the internal iliac arteries andprevent buttock claudication. In May 2019, he receivedhis left ISB, and in July 2019, an E-liac side branch prosthesis (Jotec) was implanted. Before discharge, thepatient underwent a control CTA showing thrombusformation in the aortic stent graft bifurcation extending into the right limb.30 INSERT TO ENDOVASCULAR TODAY EUROPE 2020 VOLUME 8, NO. 5To further improve flow, a 24-hour intra-arteriallow-dose thrombolysis was continued. Final angiography showed a complete resolution of the thromboticobstruction of the radial artery, the superficial palmararch, and a full recovery of the interruption of theinterdigital arteries (Figure 4). The patient was discharged with anticoagulation therapy considering theembolic background of acute ischemia.DISCUSSIONCatheter-directed thrombolysis provides a therapeutic option in situations of acute occlusive thrombusof the hand. There are times when thrombolytics arecontraindicated or fail to lyse the thrombus. In thiscase, the Indigo System offered an alternative treatment option for thrombus removal in vessels of different diameters. The Indigo System catheters range from3 to 8 F, permitting power aspiration as far as into thesuperficial palmar arch.INTERVENTIONRight femoral access was achieved with a 5-F shortsheath. An angiogram through a 5-F pigtail catheterconfirmed the findings from the CTA. There was freefloating thrombus formation riding on the bifurcation ofthe main body extending into the right ISB (Figure 1).An 8-F, 45-cm sheath (Destination, TerumoInterventional Systems) was inserted to stabilize theposition of the Indigo aspiration catheter within thestent graft limb (Figure 2).An 85-cm CAT8 TORQ aspiration catheter was carefully advanced over an 0.035-inch guidewire aspirationcatheter through the crosscut valve of the 8-F sheathusing the peel-away introducer. Once the CAT8 wasfacing the thrombus, the guidewire was removed andpower aspiration was turned on. The first pass was completed without the Separator, however, the thrombuswas already too organized to be removed without theSeparator technique. CAT8 and SEP8 were advancedcarefully into the thrombus from proximal to distal. TheSeparator was cycled back and forth to facilitate clotfragmentation at the catheter tip.When the tip of the catheter appeared to be blocked,the CAT8 was withdrawn by the millimeter with thorough movement of SEP8 until flow appeared in the tubing and then advanced again.A shot of contrast through the sheath confirmedthe full removal of thrombus after only 20 minutes(Figure 3). Control angiography showed runoff in bothlegs and ruled out distal thrombosis or emboli resulting

FEATURED TECHNOLOGYINDIGO SYSTEMSponsored by Penumbra, Inc.Figure 1. Thrombus presenting in the mainbody extending into the right limb.Figure 2. Stabilization of retrograde accessthrough the right ISB.from the intervention. The total procedure time was52 minutes.The patient was discharged with 100 mg of aspirin and75 mg clopidogrel for 3 months, then monotherapy withaspirin.DISCUSSIONThe treatment of occluded or partially occludedstent graft limbs is challenging. Full anticoagulationwith vitamin K antagonists or open embolectomymight be an option in patients without symptoms. Therisks associated with full anticoagulation are a potentialincreased risk of hemorrhagic or other complications.Residual thrombus removal and the risk of dislodgingstent graft limbs with open embolectomy may limit thesuccess rate of these procedures.The Indigo System is an essential tool that can helptreat challenging complications that may arise afterFigure 3. Successful thrombusremoval after the procedure withCAT8/SEP8.EVAR. In this case, continuous power aspiration resultedin restoration of blood flow in only 20 minutes withoutcomplication. The Indigo System’s large lumen aspiration catheter and its atraumatic distal tip allowed savingaccess into the existing prosthesis and enabled targetedthrombus removal. nDrs. Robert A. Lookstein, Miguel A. de Gregorio, AndrewGemmell, Juan José Ciampi-Dopazo, AbdulRahman Alvi,Francesco Intri

An infrarenal IVC filter (Celect Platinum, Cook Medical) was placed initially accessing the right internal jugular vein with a 9-F sheath (Brite Tip; Cordis, a Cardinal Health company). A hydrophilic guidewire passed easily through the left iliac thrombus. Venography confirmed thrombosis extending to the mid femoral vein level (Figure 1).