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Ramin hamidizadeh, emeka nzekwu, oliver halliwell; canadian association of radiologists¿ journal; 2020; 72(4) 890-897; factors influencing clinical success following endovascular treatment of type ii endoleaks; doi: 10.1177/0846537120981100.Medtronic received information in a literature article that patient's treated with onyx had complications.The purpose of the article was to compare long-term outcomes of transarterial (ta) and translumbar (tl) embolization of type ii endoleaks (t2e) following endovascular aortic aneurysm repair (evar), as well as factors that predict clinical success. 129 (mean age, 71.4 years) with t2e referred for embolization from august-2003 to december-2017 were retrospectively reviewed. in total, 180 embolizations (139 transarterial (ta), 41 translumbar (tl)) were performed by 10 interventional radiologists with 2-15 years of experience.Eleven of 129 patients were lost to follow-up.(7 ta, 4tl) due to death within 6 months of embolization.Transarterial approach: transarterial embolization was performed via a common femoral access.Most commonly the superior mesenteric artery was cannulated with a 5french base catheter and the marginal artery of drummond was negotiated with a renegade stc or progreat microcatheter.The microcatheter was passed through the inferior mesenteric artery (ima) into the endoleak sac and then attempts were made to access and embolize any involved lumbar vessels prior to using coils or liquid embolic agents to embolize the endoleak cavity and the ima. in the setting of ima occlusion or untenable access via the sma, one of the internal iliac arteries was cannulated with the 5-f base catheter and a microcather was used to negotiate the iliolumbar branch of the posterior division, via collateral vessels to a low lumbar artery in order to access the sac.With the transarterial approach, liquid embolic was usually used when considered safe, to occlude as many out-flow vessels as possible and to thrombose the endoleak cavity.Nbca and onyx both preclude the subsequent use of any other embolic agent without repeating the time-consuming process of repeated sac access, thus often coils were used first to slow and control flow through the endoleak cavity so that subsequent liquid embolic could be used in a more controlled manner.If the direction of flow was appropriate (away from the ima / sigmoid arcade) a slurry of sodium tetradecyl sulfate with gelfoam was sometimes used (before the availability of onyx) to occlude the outflow lumbar vessels if they could not be cannulated individually.Nbca was mixed with ethiodized oil in a ratio of between 1:1 and 1:3 varied by the operator to achieve the desired flow assisted distal penetration.Similarly, if onyx was being used onyx 18 was used over onyx 34 when more distal penetration was desirable.Although onyx is non-adherent, so that reflux around the catheter is less important than with nbca, it was found that if an onyx ball was formed around loops of the microcatheter, there was sufficient friction that controlled catheter withdrawal into t he ima could be difficult, with a risk of drawing onyx into the sigmoid arcade.Translumbar approach: translumbar embolization was performed in correlation with preprocedural ct scan.If the imaging findings were equivocal for the type of endoleak, time resolved sac perfusion was frequently assessed with contrast enhanced ultrasound to confirm a type ii endoleak.Fluoroscopic landmarks were identified (boney structures and radiopaque markers on the stent graft) to find the appropriate level after which the lateral position was marked on the skin.Subsequently the angle of approach was defined by positioning the c-arm so that the needle was being advanced along the same plane.A 21-gauge needle was then advanced to defined depth.The stylet was removed to demonstrate back bleeding.Once appropriate position of the needle tip had been confirmed by brisk back bleeding and sac angiography, a microwire was positioned and an introducer cannula was inserted.A microcatheter or 4-f catheter and microcatheter could then be advanced through the introducer into the endoleak cavity.At this stage coil embolization of as many feeding vessels as possible was attempted, prior to embolizing the endoleak cavity with liquid embolic with or without coils.The access sheath was usually withdrawn with injection of liquid embolic to try and ensure adequate sac hemostasis, although problems with significant retroperitoneal bleeding after translumbar embolization were not encountered.For both access techniques most operators administered antibiotic prophylaxis.Technical success was defined as successful aneurysm sac embolization and/or target branch vessel embolization. clinical success was defined as a technically successful procedure that showed sac stability or a decrease in sac size on follow up imaging, with or without a residual endoleak.Results: clinical success perpatient after all embolization attempts was 83/118 (70%) at a median follow-up time of 34 months.This was assessed by looking at the results of the most recent embolization procedure each of the 129 patients underwent.When evaluating all procedures, ta approaches had a clinical success of 52.3% (58/111) compared to 62.2% (23/37) for tl cases. successful sac access and embolization was achieved in all 41 tl procedures.For ta procedures, sac access was achieved in 87/139 (62.5%) of cases. in all onyx procedures with or without coils there was a 50% clinical success rate. adverse events: 2 patients had groin hematoma with no intervention required.1 had callateral vessel perforation with retroperitoneal extravasation.Treated with multiple coils.Procedure abandoned but patient remained asymptomatic.1 had inadvertent proximal sigmoid arcade embolization with small amount of onyx.Patient remained asymptomatic.1 had extravasation noted during procedure.Patient admitted overnight for monitoring and remained stable.And 1 periprocedural death following 24 days post a ta procedure secondary to a bacterial aortitis.
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Event related to regulatory report: 2029214-2023-01580.See attachments for literature article.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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