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Background: Acute mortality for high-risk, or massive, pulmonary embolism (PE) is almost 30% even when treated using advanced therapies. This analysis assessed the safety and effectiveness of mechanical thrombectomy (MT) for high-risk PE. Methods: The prospective, multicenter FlowTriever All-comer Registry for Patient Safety and Hemodynamics (FLASH) study is designed to evaluate real-world PE patient outcomes after MT with the FlowTriever System (Inari Medical). In this study, acute outcomes through 30 days were evaluated for the subset of patients with high-risk PE as determined by the sites and following European Society of Cardiology guidelines. An independent medical monitor adjudicated adverse events (AEs), including major AEs: device-related mortality, major bleeding, or intraprocedural device-related or procedure-related AEs. Results: Of the 799 patients in the US cohort, 63 (7.9%) were diagnosed with high-risk PE; 30 (47.6%) patients showed a systolic blood pressure <90 mm Hg, 29 (46.0%) required vasopressors, and 4 (6.3%) experienced cardiac arrest. The mean age of patients with high-risk PE was 59.4 ± 15.6 years, and 34 (54.0%) were women. At baseline, 45 (72.6%) patients were tachycardic, 18 (54.5%) showed elevated lactate levels of ≥2.5 mM, and 21 (42.9%) demonstrated depressed cardiac index of <2 L/min/m2. Immediately after MT, heart rate improved to 93.5 ± 17.9 bpm. Twenty-five (42.4%) patients did not require an overnight stay in the intensive care unit, and no mortalities or major AEs occurred through 48 hours. Moreover, no mortalities occurred in 61 (96.8%) patients followed up through the 30-day visit. Conclusions: In this cohort of 63 patients with high-risk PE, MT was safe and effective, with no acute mortalities reported. Further prospective data are needed in this population.
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OBJECTIVE: The objective of this study was to compare the outcomes of pharmacomechanical thrombolysis and thrombectomy (PCDT) plus catheter-directed thrombolysis (CDT) vs CDT alone for the treatment of acute iliofemoral deep vein thrombosis (DVT) and summarize the clinical experience, safety outcomes, and short- and long-term efficacy. METHODS: We performed a 4-year retrospective, case-control study. A total of 95 consecutive patients with acute symptomatic iliofemoral deep vein thrombosis (DVT) with a symptom duration of ≤7 days involving the iliac and/or common femoral veins underwent endovascular interventions. The patients were divided into two groups according to their clinical indications: PCDT plus CDT vs CDT alone. Statistical analyses were used to compare the clinical characteristics and outcomes between the two groups. Additionally, the patients were followed up for 3 to 36 months after treatment, and the proportions of post-thrombotic syndrome (PTS) and moderate to severe PTS were analyzed using the Kaplan-Meier survival method. RESULTS: A total of 95 consecutive patients were analyzed in this retrospective study, of whom, 51 underwent CDT alone and 44 underwent PCDT plus CDT. Between the two groups, in terms of immediate-term efficacy and safety, significant differences were found in the catheter retention time (60.64 ± 12.04 hours vs 19.42 ± 4.04 hours; P < .001), dosages of urokinase required (5.82 ± 0.81 million units vs 1.80 ± 0.64 million units; P < .001), the detumescence rate at 24 hours postoperatively (48.46% ± 8.62% vs 76.79% ± 7.98%; P = .026), the descent velocity of D-dimer per day (2266.28 ± 1358.26 µg/L/D vs 3842.34 ± 2048.02 µg/L/D; P = .018), total hospitalization stay (6.2 ± 1.40 days vs 3.8 ± 0.70 days; P = .024), number of postoperative angiograms (2.4 ± 0.80 vs 1.2 ± 0.30; P = .042), and grade III venous patency (>95% lysis: 54.5% vs 68.6%; P = .047). Furthermore, during the follow-up period, significant differences were found in the incidence of PTS (Villalta scale ≥5 or a venous ulcer: 47.0% vs 27.7%; P = .037), and the incidence proportion of moderate to severe PTS at 12 months (15.7% vs 4.5%; P = .024) and 24 months (35.3% vs 11.4%; P = .016). CONCLUSIONS: Compared with CDT alone, in the iliofemoral DVT subgroup with a symptom duration of ≤7 days, PCDT plus CDT could significantly relieve early leg symptoms, shorten the hospitalization stay, reduce bleeding complications, promote long-term venous patency, and decrease the occurrence of PTS and the incidence proportion of moderate to severe PTS. Thus, the short- and long-term outcomes both support the superiority of PCDT plus CDT vs CDT in this subgroup.
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Síndrome Postrombótico , Trombosis de la Vena , Humanos , Estudios Retrospectivos , Terapia Trombolítica/efectos adversos , Terapia Trombolítica/métodos , Fibrinolíticos , Estudios de Casos y Controles , Resultado del Tratamiento , Vena Ilíaca/diagnóstico por imagen , Vena Ilíaca/cirugía , Trombosis de la Vena/diagnóstico por imagen , Trombosis de la Vena/terapia , Trombosis de la Vena/complicaciones , Síndrome Postrombótico/diagnóstico por imagen , Síndrome Postrombótico/etiología , Síndrome Postrombótico/terapia , Catéteres/efectos adversos , Enfermedad AgudaRESUMEN
The incidence of pulmonary tumor embolism in patients with solid tumors is estimated to be between 3% and 26% yet is rarely diagnosed. In this case, a 74-year-old male with sarcomatoid variant of urothelial carcinoma and recently diagnosed left renal vein thrombus treated with low-molecular-weight-heparin, presented to the emergency department with acute syncope and dyspnea. He was found to have CT imaging of segmental and subsegmental arterial filling defects, a right atrial filling defect concerning for thrombus in transit and was diagnosed with pulmonary tumor embolism syndrome. The patient was treated with aspiration thrombectomy, with pathology demonstrating sarcomatoid urothelial carcinoma cells. He was initiated on a combination of gemcitabine plus carboplatin to decrease the tumor burden. While pulmonary tumor embolism syndrome is associated with a poor prognosis, prompt diagnosis and initiation of cancer-specific therapies can significantly improve survival.
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Removal of thrombosed inferior vena cava (IVC) filters can be complicated by the risk of thrombus embolization. A 67-year-old patient presented for temporary IVC filter retrieval with complaints of worsening lower extremity swelling. Diagnostic imaging identified significant filter thrombosis and bilateral lower extremity deep vein thrombosis (DVT). In the present case, the novel Protrieve sheath was used to successfully remove the IVC filter and thrombus, with an estimated blood loss of 100 mL. The intraprocedurally generated embolus was trapped and removed without complication. This approach could mitigate embolization risks when removing thrombosed IVC filters or complex DVT.
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OBJECTIVE: This study aimed to evaluate the safety and effectiveness of the Penumbra Indigo percutaneous aspiration thrombectomy (PAT) system in the clinical presentation of iliac limb occlusion (ILO) after endovascular aortic repair (EVAR). METHODS: A retrospective, observational, multicentre study conducted in eight Italian vascular centres. Consecutive patients presenting with ILO after EVAR were eligible. To assess vessel revascularisation, Thrombo-aspiration In Peripheral Ischaemia (TIPI) classification (score 0-3) was used at presentation (t1), after PAT (t2), and after adjunctive procedures (t3). Successful revascularisation was considered TIPI 2-3 (near complete or complete). Primary intra-operative outcomes were technical success (TS) of Indigo PAT and combined TS of PAT associated with adjunctive procedures when needed. Primary follow up outcomes were safety and effectiveness at one, six, and 12 months. RESULTS: From September 2019 to December 2021, there were 48 ILO and 17 patients (35%) [median age 75 years, IQR 71, 83 years; male, 14 (82%); urgent, 8 (47%)] were treated and enrolled. The median time after primary EVAR was 24 months (IQR 0, 42 months). The median clot age from ILO diagnosis to PAT was three days (IQR 1, 12 days). Ten patients (59%) presented with limb threatening ischaemia. At t1, TIPI 0 and 1 was present in 13 (76%) and four (24%) cases, respectively. At t2, primary TS (TIPI 2-3) was achieved in 14 cases (82%) after Indigo PAT (p < .001). Fifteen patients (88%) required adjunctive procedures (14 re-linings, one surgical patch angioplasty). At t3, combined TS was achieved in 16 cases (94%). Intra-operative complication included one (6%) distal embolisation, treated successfully. The 30 day mortality was one case (6%) due to pneumonia. At one, six, and 12 months, clinical success was 100% without ILO recurrence. The median follow up was 23 months (IQR 11, 41 months): at 18 months, survival and freedom from re-intervention were 91 ± 8% and 90 ± 9%, respectively. CONCLUSION: This study reports for the first time the efficacy and safety of Penumbra Indigo PAT for ILO after EVAR, with promising technical and clinical success up to one year.
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Aneurisma de la Aorta Abdominal , Implantación de Prótesis Vascular , Procedimientos Endovasculares , Humanos , Masculino , Anciano , Prótesis Vascular , Carmin de Índigo , Implantación de Prótesis Vascular/métodos , Estudios Retrospectivos , Resultado del Tratamiento , Aneurisma de la Aorta Abdominal/cirugía , Diseño de Prótesis , Factores de Riesgo , Trombectomía/efectos adversos , Isquemia/diagnóstico por imagen , Isquemia/etiología , Isquemia/cirugía , Sistema de Registros , Procedimientos Endovasculares/efectos adversosRESUMEN
Non-bacterial thrombotic endocarditis is an uncommon entity that tends to be related to malignancy or rheumatological disorders. The diagnosis is complex and requires a high index of suspicion. It commonly causes recurrent emboli; however, coronary embolism remains an infrequently reported entity. Herein we report a unique case of sequential pulmonary embolism, ST-elevation myocardial infarction (MI), and stroke associated with multi-valvular non-bacterial thrombotic endocarditis. The cornerstone of management is treating the underlying cause and anticoagulation therapy. Surgical treatment should be considered in patients with acute heart failure secondary to valvular dysfunction and recurrent thromboembolism despite proper anticoagulation. We have performed an extensive literature search and found nine cases of established antemortem diagnosis of myocardial infarction secondary to non-bacterial thrombotic endocarditis, and we reviewed them according to cause, treatment, and outcome.
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Purpose: To retrospectively evaluate single-centre experience in endovascular therapy (EVT) of acute superior mesenteric artery (SMA) occlusion by assessing technical success, mortality, and its dependence on the level and aetiology of occlusion. Material and methods: Eighty patients presented with acute SMA occlusion and underwent EVT at our centre from 2018 to 2020. Clinical diagnosis was confirmed by computed tomography angiography (CTA). Based on findings of CTA and digital subtraction angiography, we classified all cases by the number of SMA large branches that remained non-occluded (ostial, proximal, distal occlusion), as well as according to aetiology (embolic, thrombotic). Technical success was evaluated according to restoration of blood flow to the SMA stem and all large branches (successful, partially successful, failure). Results: Thrombotic aetiology was identified in 25.0% and embolic in 75.0% of patients. We distinguished 3 occlusion level types: ostial occlusion (23.8%), proximal occlusion (47.5%), and distal occlusion (28.7%). 67.5% of cases were technically successful, 12.5% were partially successful, and 20.0% resulted in technical failure. The 30-day mortality rate was 55.0%. EVT technical success did not statistically depend on the aetiology or on the level of occlusion. The aetiology of occlusion had no statistical significance regarding intrahospital mortality. In the group with EVT failure, fewer non-occluded large branches meant more fatal cases, and vice versa. Conclusions: Despite EVT technical success rates being adequate, mortality rates remain extremely high. While the occlusion level appeared to have no influence over EVT technical success rates, it may be a potentially useful prognostic factor in the case of failed recanalization. Aetiology of the occlusion seemed to have no impact on technical success or mortality.
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OBJECTIVE: The purpose of this study was to assess the clinical features of phlegmasia cerulea dolens and present the treatment outcomes with rheolytic thrombectomy device. METHODS: From January 2014 and March 2019, 329 patients were diagnosed and hospitalized for acute iliofemoral deep vein thrombosis, and among those patients, seven patients diagnosed with lower extremity phlegmasia cerulea dolens were consecutively enrolled. Diagnosis of phlegmasia cerulea dolens was initially made on clinical findings followed by imaging with Doppler ultrasound. The rheolytic thrombectomy device was used in all patients with a combination of catheter-directed thrombolysis as an adjunctive therapy to facilitate more rapid thrombus clearance except for one patient who had a contraindication to the use of tissue plasminogen activator. RESULTS: Seven patients (four men, three women; median age, 63 years, range 52-68 years) were included. One patient had a relative contradiction to thrombolysis due to history of coronary artery bypass graft surgery; all other patients underwent pharmaco-mechanical thrombectomy with power pulse mode. The upper limit of 480 s was completed in all patients, and this time was not exceeded to prevent hemolysis-related complications. Six Fr catheters were used in four (57.1%) patients, and 8 Fr catheters were used in three patients (42.9%). Mean thrombolytic infusion duration was 28 ± 6.2 h for patients who received tissue plasminogen activator. After catheter-directed thrombolysis, total radiological success was achieved in two patients, and partial radiologic success was achieved in five patients; however, in all seven patients, clinical success was achieved. The mean duration for complete regression of cyanosis was 18.9 ± 8.1 h. Although no patients required blood replacement, mean decreases in hemoglobin and hematocrit were 2.7 ± 1.37 g/dl and 6.42 ± 4.47%, respectively. Acute kidney injury developed in three patients (42.9%). One patient required continuous renal replacement therapy. No cardiac complication was observed. One (14.3%) patient died of ventilator-related pneumonia on postprocedural day 10. The median duration of intensive care unit stay and hospital stay were 72 h (min-max: 24-264 h) and six days (min-max: 5-33 days), respectively. CONCLUSION: Rheolytic thrombectomy was less invasive and effective strategy for early stage phlegmasia cerulea dolens at creating rapid thrombus clearance to establish clinical success and facilitate more conservative management with catheter-directed thrombolysis.
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Trombectomía/instrumentación , Tromboflebitis/terapia , Trombosis de la Vena/terapia , Anciano , Femenino , Fibrinolíticos/administración & dosificación , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Trombectomía/efectos adversos , Terapia Trombolítica , Tromboflebitis/diagnóstico por imagen , Tromboflebitis/fisiopatología , Factores de Tiempo , Activador de Tejido Plasminógeno/administración & dosificación , Resultado del Tratamiento , Trombosis de la Vena/diagnóstico por imagen , Trombosis de la Vena/fisiopatologíaRESUMEN
OBJECTIVE: To evaluate efficacy, safety and feasibility of targeted intracoronary injection using pro-urokinase combined with anisodamine (TCA) versus thrombus aspiration (TA) in ST-elevation myocardial infarction (STEMI) patients with high thrombus loads. BACKGROUND: The best method of avoiding thrombus detachment and stroke in PCI patients with high thrombus loads has not yet been established. METHODS: STEMI patients receiving coronary artery angiography or percutaneous coronary intervention (CAG/PCI) with thrombus grade ≥ 3 from January 1, 2017 to June 30, 2018 were randomly assigned to targeted intracoronary thrombolysis (pro-urokinase and anisodamine via catheter (TCA) group), or the TA group which followed the standard thrombus aspiration procedure. Parameters compared included thrombus grade, index of microcirculatory resistance (IMR), postoperative myocardial SPECT, thrombosis in myocardial infarction (TIMI) scores including flow grade, corrected TIMI frame counts (CTFCs), and TIMI myocardial perfusion grade (TMPG). Adverse events were followed up within 3 months. RESULTS: Thirty-nine patients were finally enrolled. In primary CAG/PCI, the TCA group had higher percentages of TIMI 3 flow and lower IMR values compared with the TA group. The ratio of TMPG 3 grade in the TCA group was higher in repeat CAG, and the perfusion descending area (PDA) presented by SPECT was lower than in the TA group. No significant difference was seen in major adverse coronary events (MACEs) or bleeding events at follow-up. CONCLUSIONS: TCA appears to be effective, safe, and feasible for repatency and reduction of high thrombus burden in primary PCI and may protect myocardial microcirculation with improved outcomes.