Project description:PURPOSE:The purpose of this study is to assess the incremental effect of tissue plasminogen activator (t-PA) dose on pulmonary artery pressure (PAP) and bleeding during catheter directed thrombolysis (CDT) of submassive pulmonary embolism (PE). MATERIALS AND METHODS:Records of 46 consecutive patients (25 men, 21 women, mean age 55±14 y) who underwent CDT for submassive PE between September 2009 and February 2017 were retrospectively reviewed. Mean t-PA rate was 0.7±0.3 mg/h. PAP was measured at baseline and daily until CDT termination. Mixed-effects regression modeling was performed of repeated PAP measures in individual patients. Bleeding events were classified by Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO) and t-PA dose at onset. RESULTS:Mean t-PA dose was 43.0±30.0 mg over 61.9± 28.8 h. Mean systolic PAP decreased from 51.7±15.5 mmHg at baseline to 35.6±12.7 mmHg at CDT termination (p<0.001). Mixed-effects regression revealed a linear decrease in systolic PAP over time (β = -0.37 (SE = 0.05), p<0.001) with reduction in mean systolic PAP to 44.8±1.9 mmHg at 12 mg t-PA/20 h, 39.5±2.0 mmHg at 24 mg t-PA/40 h, and 34.9±2.1 mmHg at 36 mg/60 h. No severe, one moderate, and 8 mild bleeding events occurred; bleeding onset was more frequent at ≤24 mg t-PA (p <0.001). One patient expired from cardiopulmonary arrest after 16 h of CDT (15.4 mg t-PA); no additional intra-procedural fatalities occurred. CONCLUSION:Increased total t-PA dose and CDT duration were associated with greater PAP reduction without increased bleeding events.
Project description:In this review, the current status of the worldwide experience on different catheter-directed treatment systems utilized as alternative reperfusion methods in acute pulmonary-embolism was evaluated, and the risk stratification algorithms in which catheter-directed treatments may be implemented, source of evidence in this setting, adjudication of benefits and risks of available techniques, and innovative multidisciplinary frameworks for referral patterns and care delivery were discussed. Moreover, our perspectives on risk-based catheter-directed treatment utilization strategies in acute pulmonary embolism were summarized.
Project description:BackgroundThe optimal therapy for patients suffering from acute pulmonary embolism (PE) classified as intermediate-high risk still needs to be identified. Catheter-directed thrombectomy (CDTE) is a safe procedure to reduce thrombus burden immediately. The lack of randomized trials is one reason: catheter-directed thrombolysis (CDT) has not yet received a clear recommendation in our guidelines. Herein, we report an unexpected event in the course of a patient with PE treated with CDTE using the FlowTriever™ system, the only FDA-approved catheter system for percutaneous mechanical thrombectomy regarding this indication.Case summaryA 57-year-old male presented with dyspnoea at the emergency department of our university hospital. The computed tomography (CT) scan showed bilateral PE, and ultrasound of the left lower limb revealed deep venous thrombosis. According to the current ESC guidelines, he was classified intermediate-high risk. We performed bilateral CDTE. On the first and third day post-intervention, our patient presented neurological deficits. Whereas the first CT scan of the cerebrum remained normal, the CT scan at Day 3 showed demarcated embolic stroke. Further imaging diagnostic gave evidence to an ischemic lesion in the left kidney. Transesophageal echocardiography revealed a patent foramen ovale (PFO) as the origin of paradoxical embolism and thus mechanism of both ischemic lesions. Compliant to the current recommendations, percutaneous PFO closure was performed. Our patient recovered properly without any sequelae.DiscussionWhether the deep venous thrombosis is the source of embolization or the catheter-directed retrieval of clots may have transported clot material to the right atrium which further on embolized systemically will remain unclear. Yet, we have to consider it as a potential complication in catheter-directed treatment of PE in patients with a PFO.
Project description:(1) Background: Catheter-directed therapies (CDT) may be considered for selected patients with pulmonary embolism (PE); (2) Methods: Retrospective observational study including all consecutive patients with acute PE undergoing CDT (mechanical or pharmacomechanical) from January 2010 through December 2020. The aim was to evaluate in-hospital and long-term mortality and its predictive factors; (3) Results: We included 63 patients, 43 (68.3%) with high-risk PE. All patients underwent mechanical CDT and, additionally, 27 (43%) underwent catheter-directed thrombolysis. Twelve (19%) patients received failed systemic thrombolysis (ST) prior to CDT, and an inferior vena cava (IVC) filter was inserted in 28 (44.5%) patients. In-hospital PE-related and all-cause mortality rates were 31.7%; 95% CI 20.6-44.7% and 42.9%; 95% CI 30.5-56%, respectively. In multivariate analysis, age > 70 years and previous ST were strongly associated with PE-related and all-cause mortality, while IVC filter insertion during the CDT was associated with lower mortality rates. After a median follow-up of 40 (12-60) months, 11 more patients died (mortality rate of 60.3%; 95% CI 47.2-72.4%). Long-term survival was significantly higher in patients who received an IVC filter; (4) Conclusions: Age > 70 years and failure of previous ST were associated with mortality in acute PE patients treated with CDT. In-hospital and long-term mortality were lower in patients who received IVC filter insertion.
Project description:Systemic thrombolysis for acute pulmonary embolism (PE) reduces the risk of death and cardiovascular collapse but is associated with an increased rate of bleeding. The desire to minimize the risk of bleeding events has driven the development of catheter-based strategies for pulmonary reperfusion in PE. These catheter-based strategies utilize lower-dose fibrinolytic regimens or purely mechanical techniques to expedite removal of the embolus. Several devices providing mechanical or suction embolectomy and catheter-directed thrombolysis, with or without facilitation by ultrasound, have been tested. Data are inconsistent regarding the efficacy and safety of mechanical and suction embolectomy. The most comprehensive data on catheter-based techniques stem from trials of ultrasound-facilitated catheter fibrinolysis. Ultrasound-facilitated catheter fibrinolysis relieves right ventricular pressure overload with a lower risk of major bleeding and intracranial haemorrhage than historical rates with systemic fibrinolysis. However, further research is required to determine the optimal application of ultrasound-facilitated catheter fibrinolysis and other catheter-based therapies in patients with acute PE.
Project description:BackgroundPulmonary embolism (PE) is an acute cardiovascular syndrome characterized by high incidence and mortality. The therapy of this condition is based on anticoagulation and hemodynamic support, but in case of high-risk mortality, the European Society of Cardiology (ESC) guidelines recommend systemic thrombolytic therapy and surgical embolectomy if thrombolysis is contraindicated or has failed; nowadays several percutaneous catheter-directed treatments for local thrombolysis or mechanical embolectomy are available, but they have IIa class of recommendation, because of lack of robust scientific evidence favoring their use.Case descriptionWe described a case of high-risk PE treated with a novel percutaneous system for mechanical embolectomy, which consists of a large aspiration catheter that was advanced in the pulmonary artery, capturing and removing a vast thrombus, of 15 centimeters in length. This therapeutic strategy avoided the risk of hemorrhagic complications related to systemic thrombolysis, exiting in the achievement of fast patient hemodynamic stabilization and symptoms resolution, without complications. Computed tomography (CT) pulmonary angiography after 10 days from the intervention revealed the complete resolution of pulmonary artery filling defects, and the patient was discharged asymptomatic.ConclusionsPercutaneous catheter-directed treatments represent an effective alternative therapy for PE, but further studies are needed to demonstrate safety and superiority over the actually recommended therapy.
Project description:BackgroundFirst-line treatment of high-risk pulmonary embolism with persistent hypotension and/or signs of shock is intravenous thrombolysis. However, if thrombolysis is contraindicated due to risk of serious bleeding, or if it yields insufficient effect, surgical thrombectomy or catheter-directed intervention (CDI) plus anticoagulation is recommended. The aim of this study was to assess the outcomes of the CDI modality introduced in a tertiary referral centre in 2013.MethodsRetrospective comparison between patients treated with CDI plus anticoagulation (n = 22) and patients treated with anticoagulation only (n = 23) as used before the CDI technique was available. The main outcomes of interest were 90-day survival and reduction of right to left ventricle diameter (RV/LV) ratio, using the Fischer's exact test and a mixed model, respectively, for statistical analysis.ResultsNinety-day survival was 59% after CDI and 61% after anticoagulation only; P = .903. The rate of RV/LV ratio reduction was 0.4 units higher per 24 hours in the CDI group (median 2.1 pre-treatment), than in the anticoagulation only group (median 1.3 pre-treatment); P = .007.ConclusionIn patients with high-risk pulmonary embolism, 90-day survival was similar after treatment with CDI plus anticoagulation compared to anticoagulation only. The mean reduction in RV/LV ratio was larger in the CDI group. Our results support the use of CDI in selected patients, respecting the limitations and potential side effects of each technical device used.
Project description:Ultrasound-facilitated and catheter-directed low-dose fibrinolysis (EKOS) has shown favorable hemodynamic and safety outcomes in intermediate- to high-risk pulmonary embolism (PE) cases. This prospective single-arm monocentric study assessed the effects of using a delivery catheter for fibrinolysis as a novel approach for acute intermediate- to high-risk patients on pulmonary artery hemodynamics PE. Forty-five patients (41 intermediate-high and 4 high risk) with computer tomography (CT)-confirmed PE underwent EKOS therapy. By protocol, a total of 6 mg of tissue-plasminogen activator (t-PA) was administered over 6 h in the pulmonary artery (unilateral 6 mg or bilateral 12 mg). Unfractionated heparin was provided periprocedurally. The primary safety outcome was death, as well as major and minor bleeding within 48 of procedure initiation and at 90 days. The primary effectiveness outcomes were: 1. to assess the difference in pulmonary artery pressure from baseline to 6 h post-treatment as a primary precise surrogate marker, and 2. to determine the echocardiographic RV/LV ratio from baseline to 48 h and at 90 days post-delivery. Pulmonary artery pressure decreased by 15/6/10 mmHg (p < 0.001). The mean RV/LV ratio decreased from 1.2 ± 0.85 at baseline to 0.85 ± 0.12 at 48 and to 0.76 ± 0.13 at 90 days (p < 0.001). Five patients (11%) died within 90 days of therapy. Pulmonary artery hemodynamics were assessed using a delivery catheter for fibrinolysis, which is reproducible for identifying PE at risk of adverse outcomes. The results matched the right heart catheter results in EKOS and Heparin arm of Ultima trial, thereby confirming the validity of this potential diagnostic tool to assess therapy effectiveness and thereby reduce additional procedure-related complications, hospital residency, and economics. These results stress the importance of having an interdisciplinary team involved in the management of PE to evaluate the quality of life of these patients and this protocol shortens ICU admission to 6 h.