See manufacturer report # 2029214-2022-00672 for another event from this article.Liang nl, chaer ra, chaer lk, singh mj, makaroun ms, avgerinos ed.Midterm outcomes of catheter-directed interventions for the treatment of acute pulmonary embolism.Vascular.2017;25(2):130-136.Doi:10.1177/1708538116654638.If information is provided in the future, a supplemental report will be issued.
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Liang nl, chaer ra, marone lk, singh mj, makaroun ms, avgerinos ed.Midterm outcomes of catheter-directed interventions for the treatment of acute pulmonary embolism.Vascular.2017;25(2):130-136.Doi:10.1177/1708538116654638.Medtronic literature review found a report of patient complications in association with cragg-mcnamara infusion catheter.The purpose of this article was to report midterm outcomes of catheter directed thrombolysis for treatment of acute pulmonary embolism (pe).A total of 69 were included in the study.The average age was 59 years, and the majority were female (39).Of these, 36 patients underwent ultrasound-accelerated thrombolysis (usat), 27 patients had standard catheter-directed thrombolysis (cdt), and 6 patients had aspiration thrombectomy, rheolysis, or catheter- directed on-table single-dose thrombolytic therapy performed.Cdt procedures requiring continuous infusion of thrombolytic were accomplished using the cragg-mcnamara or unifuse catheters.It is unclear how many of each were used. the article does not state any technical issues during use of the cragg-mcnamara infusion catheter.The following intra- or post-procedural outcomes were noted: - two patients died perioperatively: one patient with intermediate-risk pe successfully completed usat with a good initial result but suffered a sudden cardiac arrest and death just prior to anticipated discharge.The other patient presented with high-risk pe and hemodynamic instability, arresting and expiring on the operating room table after initial placement of catheters and delivery of alteplase loading dose but prior to initiation of continuous lytic infusion.- the estimated overall survival was 96.8% at 30 days, 90.3% at 90 days, and 81.2% at one year.- six patients, all undergoing cdt or usat, met criteria for hemodynamic decompensation after initiation of catheter-directed therapy.Of these six, three had high-risk pe with preexisting hemodynamic instability, and three had new-onset postoperative hypotension.Two of these patients died as mentioned previously, one before and one after initiation of continuous lytic infusion; three patients progressed to surgical embolectomy; and one patient recovered without intervention and was discharged to a long-term acute care facility.The median length of icu stay was two days.Hemodynamic decompensation was defined as new-onset sustained hypotension, new requirement for inotropes or vasopressors, or continued or worsening hypotension despite treatment.- eight patients met criteria for a major non-mortality adverse event: three surgical embolectomy, two major bleeding events requiring intervention or transfusion, two patients with respiratory failure requiring tracheostomy, and one patient with a tricuspid valve rupture after suction thrombectomy with the angio-vac device requiring valve replacement.- there were six minor bleeding events, which was defined as all other clinically significant bleeding events without need for transfusion or intervention.- two patients had documented recurrent pe events during the follow-up period.
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