Catheter-directed therapies for the treatment of high risk (massive) and intermediate risk (submassive) acute pulmonary embolism.
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ABSTRACT:
SUBMITTER: Harvey JJ
PROVIDER: S-EPMC9358724 | biostudies-literature | 2022 Aug
REPOSITORIES: biostudies-literature
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Catheter-directed therapies for the treatment of high risk (massive) and intermediate risk (submassive) acute pulmonary embolism.
Harvey John J JJ Huang Shiwei S Uberoi Raman R
The Cochrane database of systematic reviews 20220808
<h4>Background</h4>Acute pulmonary embolism (APE) is a major cause of acute morbidity and mortality. APE results in long-term morbidity in up to 50% of survivors, known as post-pulmonary embolism (post-PE) syndrome. APE can be classified according to the short-term (30-day) risk of mortality, based on a variety of clinical, imaging and laboratory findings. Most mortality and morbidity is concentrated in high-risk (massive) and intermediate-risk (submassive) APE. The first-line treatment for APE ...[more]
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Project description:BackgroundCatheter-directed thrombolysis (CDL) is increasingly being used for the treatment of submassive and massive pulmonary embolism. Although this therapy has been shown to be effective at reducing right ventricle strain, the impact on clinical outcomes remains unclear. We therefore aimed to evaluate the outcomes of CDL compared to standard anticoagulation for submassive pulmonary embolism patients in a large cohort.MethodsWe conducted a retrospective observational study of consecutive patients with a primary diagnosis of submassive pulmonary embolism admitted to an intensive care unit within our health system between June 2014 and April 2016. We compared the outcome of patients treated with systemic anticoagulation (medical therapy) vs. catheter-based delivery of tissue plasminogen activator (tPA) (CDL). CDL patients were matched with medical therapy controls using a propensity-score matching algorithm based on the components of the simplified pulmonary embolism severity index (sPESI) score.ResultsUnadjusted mortality rates were 3.0% for CDL vs. 10.4% for medical therapy at 30 days and 8.1% for CDL vs. 22.9% for medical therapy at 1 year. In the propensity-score matched cohort, mortality rates were 3.1% for CDL vs. 6.1% for medical therapy at 30 days and 8.2% for CDL vs. 18.2% for medical therapy at 1 year. Length of stay was significantly shorter in the CDL group. The index admission bleeding and transfusion rates were not increased in the CDL group.ConclusionsIn patients presenting with acute submassive pulmonary embolism who are admitted to an intensive care unit, the group treated with CDL experienced reduced mortality at 30 days and 1 year when compared to medical therapy without increase in bleeding. Further randomized studies are required to confirm these findings.
| S-EPMC7144676 | biostudies-literature
Project description:BackgroundThe optimal therapy for submassive pulmonary embolism remains in question. The following meta-analysis compiles the current evidence comparing Catheter-Directed Thrombolysis (CDT) versus Systemic Anticoagulation (SA).MethodsAn electronic search through PubMed and Google scholar revealed studies comparing CDT versus SA in terms of mortality and major bleeding events. Thirty-day, 90-day, and one-year mortality results were analyzed.ResultsSix studies were included in the meta-analysis. Thirty-day and one-year mortality were less with CDT compared to SA (OR 0.27 [CI 0.11-0.67]; and OR 0.50 [CI 0.28-0.89]). Ninety-day mortality was similar between the two methods (OR 0.57 [CI 0.17-1.92]). Compilation of all studies reporting at least greater than 30-day mortality revealed less mortality with CDT (OR 0.51 [0.30-0.86]). Major bleeding was similar between the two treatments (OR 1.63 [CI 0.63-4.20]).ConclusionCDT has less 30-day and 1-year mortality with equivalent rates of major bleeding compared to SA for treatment of submassive pulmonary embolism.
| S-EPMC9241122 | biostudies-literature
Project description:BackgroundLittle data exist on the use of direct oral anticoagulant (DOAC) factor Xa inhibitors for submassive pulmonary embolism (PE) after catheter-directed thrombolysis (CDT). The objective of this evaluation was to determine whether the transition from parenteral anticoagulation to DOACs for submassive PE after CDT would decrease hospital length of stay (LOS) compared to warfarin.MethodsA retrospective review of patients diagnosed with submassive PE who underwent CDT was conducted from January 1, 2012, to February 28, 2017. Hospital LOS and major and minor bleeding events were recorded during hospitalization and at 90 days.ResultsSixty-two patients met the inclusion criteria, 36 in warfarin group and 26 in the DOAC group. Overall, patients receiving rivaroxaban or apixaban had a shorter median hospital LOS compared to warfarin (4.0 vs 6.1 days, P = .002). In the multivariate regression analysis, administration of DOAC was an independent predictor of decreased hospital LOS, β: -2.1, 95% confidence interval (-3.5 to -0.7).ConclusionAmong patients with submassive PE, initiation of a DOAC shortly after CDT may result in a decreased hospital LOS compared to parenterally bridged warfarin.
| S-EPMC6714714 | biostudies-literature
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.
| S-EPMC6364916 | biostudies-literature
Project description:BackgroundCatheter-directed thrombolysis (CDT) and large-bore mechanical thrombectomy (MT) are the leading percutaneous-based therapies for the management of intermediate-risk pulmonary embolism (PE). While previous studies have demonstrated their procedural safety and efficacy, the cost implications of these interventions remain unclear. This study aims to conduct a cost-benefit analysis to evaluate the economic advantages associated with CDT and MT from the perspective of the treating hospital.MethodsA total of 372 consecutive patients with intermediate-risk acute PE who underwent either MT or CDT at 3 academic centers between 2013 and 2021 were included in this analysis. The costs of care incurred during the index hospitalization for the 2 treatment groups were collected and compared using an adjusted cost model.ResultsThis study compared the hospital costs of 226 patients who underwent CDT and 146 patients who underwent MT. In the unadjusted overall cohort, the use of CDT was associated with a numerical but nonsignificant increase in costs amounting to $5120 relative to MT (P = .062). This cost difference was primarily driven by the longer length of stay in the intensive care unit and hospital for CDT patients, particularly earlier in the studied timeframe. However, when accounting for confounders including variations between the treating institutions and the timing of treatment during the study period, the adjusted cost differential between CDT and MT narrowed to $1351 (P = .71).ConclusionsThis multicenter cost analysis does not reveal a clear cost advantage of 1 treatment over the other for intermediate-risk PE. The observed cost differences were influenced by variations in practice patterns across the study period and among the 3 participating institutions. Future efforts should also focus on strategies to reduce the length of stay, improve efficiency, and minimize the overall cost of care for intermediate-risk PE patients.
| S-EPMC11308306 | biostudies-literature
Project description:BackgroundThe benefit of catheter-directed therapy (CDT) for submassive pulmonary embolism (sPE) has been the subject of debate. We sought to determine the short- and long-term mortality and outcomes of CDT compared with anticoagulation for patients with sPE.MethodsWe performed a single healthcare network, multihospital, retrospective cohort study of hospitalizations for sPE from 2012 to 2019. sPE was defined as the presence of right heart strain or elevated biomarkers (troponin I or B-type natriuretic peptide). Patients with massive PE and those who had undergone systemic thrombolysis were excluded. The sPE groups included therapeutic anticoagulation alone or anticoagulation plus CDT (ie, thrombolysis or suction thrombectomy). The primary outcome was mortality at 1, 3, and 5 years. The other measured outcomes included PE-related death, short term mortality (30 days and 3 and 6 months), 30-day treatment-related complications (eg, bleeding, transfusion, stroke), chronic thromboembolic pulmonary hypertension, and 6-minute walk test at 1 year. After 1:1 nearest-neighbor propensity score matching, Kaplan-Meier survival plots were generated, and the treatment groups were compared using log-rank testing. We used Cox multivariate analysis to evaluate the outcomes after clustering at the hospital level, generating matched hazard ratios (mHRs) with associated 95% confidence intervals (CIs).ResultsOf 6746 sPE hospitalizations, the patients who had received CDT were younger (age, 58.9 ± 15.5 years vs 61.5 ± 17.4 years; P = .004), were more frequently White (92.5% vs 85.7%; P < .001), and had presented with a higher mean heart rate (104.6 bpm vs 94.9 bpm; P < .001), lower median systolic blood pressure (129 mm Hg vs 135 mm Hg; P < .001), and a greater incidence of right heart strain (79.2% vs 20.3%; P < .001). A total of 470 patients were matched, with 235 in the CDT group and 235 in the anticoagulation-only group. CDT was associated with a lower risk of mortality compared with anticoagulation at 1 year (7.6% vs 9.8%; mHR, 0.77; 95% CI, 0.65-0.92; P = .004), 3 years (11.1% vs 16.6%; mHR, 0.64; 95% CI, 0.55-0.73; P < .001), and 5 years (14.5% vs 19.1%; mHR, 0.71; 95% CI, 0.66-0.77; P < .001). Anticoagulation alone resulted in a greater incidence of PE-related deaths at 1, 3, and 5 years. The mortality at 30 days and 3 months was similar; however, CDT had resulted in better survival at 6 months (mHR, 0.81; 95% CI, 0.68-0.97; P = .02). No differences were found between the two groups in the incidence of bleeding complications at 30 days, development of chronic thromboembolic pulmonary hypertension, or the mean walking distance at 1 year.ConclusionsCDT plus anticoagulation for sPE was associated with improved long-term survival compared with anticoagulation alone, with a lower incidence of PE-related death and a low complication rate. CDT should be considered for select patients with sPE given its survival benefit.
| S-EPMC10024252 | biostudies-literature
Project description:ImportanceThe optimal treatment of intermediate-high-risk pulmonary embolism (PE) remains unknown.ObjectiveTo assess the effect of conventional catheter-directed thrombolysis (cCDT) plus anticoagulation vs anticoagulation monotherapy in improving echocardiographic measures of right ventricle (RV) to left ventricle (LV) ratio in acute intermediate-high-risk PE.Design, setting, and participantsThe Catheter-Directed Thrombolysis vs Anticoagulation in Patients with Acute Intermediate-High-Risk Pulmonary Embolism (CANARY) trial was an open-label, randomized clinical trial of patients with intermediate-high-risk PE, conducted in 2 large cardiovascular centers in Tehran, Iran, between December 22, 2018, through February 2, 2020.InterventionsPatients were randomly assigned to cCDT (alteplase, 0.5 mg/catheter/h for 24 hours) plus heparin vs anticoagulation monotherapy.Main outcomes and measuresThe proportion of patients with a 3-month echocardiographic RV/LV ratio greater than 0.9, assessed by a core laboratory, was the primary outcome. The proportion of patients with an RV/LV ratio greater than 0.9 at 72 hours after randomization and the 3-month all-cause mortality were among secondary outcomes. Major bleeding (Bleeding Academic Research Consortium type 3 or 5) was the main safety outcome. A clinical events committee, masked to the treatment assignment, adjudicated clinical outcomes.ResultsThe study was prematurely stopped due to the COVID-19 pandemic after recruiting 94 patients (mean [SD] age, 58.4 [2.5] years; 27 women [29%]), of whom 85 patients completed the 3-month echocardiographic follow-up. Overall, 2 of 46 patients (4.3%) in the cCDT group and 5 of 39 patients (12.8%) in the anticoagulation monotherapy group met the primary outcome (odds ratio [OR], 0.31; 95% CI, 0.06-1.69; P = .24). The median (IQR) 3-month RV/LV ratio was significantly lower with cCDT (0.7 [0.6-0.7]) than with anticoagulation (0.8 [0.7-0.9); P = .01). An RV/LV ratio greater than 0.9 at 72 hours after randomization was observed in fewer patients treated with cCDT (13 of 48 [27.0%]) than anticoagulation (24 of 46 [52.1%]; OR, 0.34; 95% CI, 0.14-0.80; P = .01). Fewer patients assigned to cCDT experienced a 3-month composite of death or RV/LV greater than 0.9 (2 of 48 [4.3%] vs 8 of 46 [17.3%]; OR, 0.20; 95% CI, 0.04-1.03; P = .048). One case of nonfatal major gastrointestinal bleeding occurred in the cCDT group.Conclusions and relevanceThis prematurely terminated randomized clinical trial of patients with intermediate-high-risk PE was hypothesis-generating for improvement in some efficacy outcomes and acceptable rate of major bleeding for cCDT compared with anticoagulation monotherapy and provided support for a definitive clinical outcomes trial.Trial registrationClinicalTrials.gov Identifier: NCT05172115.
| S-EPMC9582964 | biostudies-literature
Project description:Little data exist regarding the functional capacity of patients following acute pulmonary embolism. We sought to characterize the natural history of symptom burden, right ventricular (RV) structure and function, and exercise capacity among survivors of massive and submassive pulmonary embolism. Survivors of submassive or massive pulmonary embolism (n=20, age 57±13.3 years, 8/20 female) underwent clinical evaluation, transthoracic echocardiography, and cardiopulmonary exercise testing at 1 and 6 months following hospital discharge. At 1 month, 9/20 (45%) patients had New York Heart Association II or greater symptoms, 13/20 (65%) demonstrated either persistent RV dilation or systolic dysfunction, and 14/20 (70%) had objective exercise impairment as defined by a peak oxygen consumption (V˙O2) of <80% of age-sex predicted maximal values (16.25 [13.4-20.98] mL/kg per minute). At 6 months, no appreciable improvements in symptom severity, RV structure or function, and peak V˙O2 (17.45 [14.08-22.48] mL/kg per minute, P=NS) were observed. No patients demonstrated an exercise limitation attributable to either RV/pulmonary vascular coupling, as defined by a VE/VCO2 slope >33, or a pulmonary mechanical limit to exercise at either time point. Similarly, persistent RV dilation or dysfunction was not significantly related to symptom burden or peak V˙O2 at either time point. Persistent symptoms, abnormalities of RV structure and function, and objective exercise limitation are common among survivors of massive and submassive pulmonary embolism. Functional impairment appears to be attributable to general deconditioning rather than intrinsic cardiopulmonary limitation, suggesting an important role for prescribed exercise rehabilitation as a means toward improved patient outcomes and quality of life.
| S-EPMC5866315 | biostudies-literature
Project description:Approximately 30-50% of hemodynamically stable patients presenting with acute pulmonary embolism (PE) have evidence of right ventricular (RV) dysfunction. These patients are classified as submassive PE and the role of reperfusion therapy remains unclear. We sought to identify the circumstances under which catheter-directed thrombolysis (CDT) would represent high-value care for submassive PE. We used a computer-based, individual-level, state-transition model with one million simulated patients to perform a cost-effectiveness analysis comparing the treatment of submassive PE with CDT followed by anticoagulation to treatment with anticoagulation alone. Because RV function impacts prognosis and is commonly used in PE outcomes research, our model used RV dysfunction to differentiate health states. One-way, two-way, and probabilistic sensitivity analyses were used to quantify model uncertainty. Our base case analysis generated an incremental cost-effectiveness ratio (ICER) of $119,326 per quality adjusted life year. Sensitivity analyses resulted in ICERs consistent with high-value care when CDT conferred a reduction in the absolute probability of RV dysfunction of 3.5% or more. CDT yielded low-value ICERs if the absolute reduction was less than 1.56%. Our model suggests that catheter-directed thrombolytics represents high-value care compared to anticoagulation alone when CDT offers an absolute improvement in RV dysfunction of 3.5% or more, but there is substantial uncertainly around these results. We estimated the monetary value of clarifying the costs and consequences surrounding RV dysfunction after submassive PE to be approximately $268 million annually, suggesting further research in this area could be highly valuable.
| S-EPMC8314388 | biostudies-literature
Project description:BackgroundEarly data on use of catheter-directed therapies (CDT) for treatment of Intermediate or High-Risk pulmonary embolism (PE) show improvement in pulmonary artery systolic pressures (PAsP) and RV/LV ratios. Occasionally a paradoxical rise in PAsP was observed with CDT utilizing ultrasound-assisted thrombolysis (USAT). It is unclear whether this pattern is seen with CDT utilizing mechanical aspiration.ObjectivesTo investigate and compare the changes in PAsP between those who underwent CDT with USAT to those with mechanical aspiration.MethodsA retrospective analysis of those diagnosed with Intermediate or High-Risk PE who underwent CDT using USAT or mechanical aspiration from 7/2013 to 3/2023. The primary outcome was comparison of PAsP changes between the two modalities. Secondary outcomes include length of stay, mortality, and bleeding complications.ResultsA total of 142 patients were analyzed, of which 93 underwent USAT and 49 underwent mechanical thrombectomy. The mechanical thrombectomy group had significantly lower post-intervention PAsP than the USAT group (42.2 ± 13.4 mmHg vs 54.5 ± 15.2 mmHg, p < 0.0001) and a greater adjusted mean reduction (-16.5 ± 2.7 vs. -7.7 ± 3.2 mmHg. p < 0.0001). A higher frequency of a paradoxical rise in PAsP was observed in the USAT group (22 % vs 4.1 %, p < 0.001).ConclusionsCDT utilizing mechanical thrombectomy was associated with lower post-interventional PAsP and greater mean negative change compared to USAT. Occasional paradoxical rises in PAsP were observed with both types of CDT, but they were more frequent with USAT. Hemodynamic monitoring should be considered after CDT.Condensed unstructured abstractWe report a retrospective comparison of changes to pulmonary artery systolic pressures (PAsPs) between catheter-directed ultrasound-assisted thrombolysis (USAT) and catheter-directed mechanical thrombectomy in Intermediate and High-Risk pulmonary embolism. Those treated with mechanical thrombectomy compared to USAT had significantly lower post-interventional PAsP (42.2 ± 13.4 mmHg vs 54.5 ± 15.2 mmHg, p < 0.0001) and a greater adjusted mean reduction (-16.2 ± 2.7 vs. -7.5 ± 3.2 mmHg, p < 0.0001). A paradoxical rise in PAsP was observed more frequently in the USAT group than the mechanical thrombectomy group (22 % vs 4.1 %, p < 0.001).
| S-EPMC10946050 | biostudies-literature