Thrombolysis For Submassive Pulmonary Embolism Research Articles

Predictors of chronic thromboembolic pulmonary hypertension in patients with submassive pulmonary embolism treated with catheter-directed thrombolysis versus anticoagulation alone: A secondary analysis of the SUNSET sPE trial

ObjectiveChronic thromboembolic pulmonary hypertension (CTEPH) after pulmonary embolism (PE) is a morbid complication with suboptimal treatment. We aimed to evaluate the biomarker profile and functional outcomes in patients with submassive PE (sPE) treated with catheter-directed thrombolysis (CDT) compared with anticoagulation alone (ACA). We performed a secondary biomarker and survey analysis of the SUNSET sPE (standard vs ultrasound-assisted catheter thrombolysis for submassive pulmonary embolism) randomized trial comparing standard CDT to ultrasound-assisted thrombolysis in patients with sPE. MethodsAs a part of the SUNSET sPE study, patients who did not receive an intervention were enrolled in the medical (ACA) arm. The biomarkers associated with CTEPH in the literature (ie, CCL2, CXCL10, PTX3, GDF-15, RAGE, BCA-1, TFPI) were collected and measured using a multiplex assay at diagnosis, discharge, and 3-month follow-up. Patients underwent a 6-minute walk test and answered quality-of-life questionnaires (pulmonary embolism quality of life; University of California, San Diego, shortness of breath questionnaire; 36-item short-form survey) at 3 months after diagnosis. Comparisons were made using the Student t test. Nonparametric tests were used when the distributions were not normal. Significance was set at P ≤ .05. ResultsA total of 72 patients (age, 56 ± 15 years; 40.3% women) were included in the present analysis. Of these 72 patients, 53 underwent CDT and 19 were included in the ACA arm. The baseline right ventricle/left ventricle ratios were similar between the two groups (CST, 1.8; ACA, 1.7). The survival and complication rates were similar between the two groups. At discharge, CXCL10 (768.9 ± 148.6 pg/mL vs 3032.0 ± 1201.0 pg/mL; P = .018) and PTX3 (3203.5 ± 1298.0 pg/mL vs 12,716.2 ± 6961.5 pg/mL; P = .029) were lower in the CDT group and displayed a quicker return to baseline than in the ACA group. This trend, although not significant, was also seen with the other biomarkers. At 3 months, the 6-minute walking distance and quality-of-life scores were similar between both groups. ConclusionsIn patients with sPE, the biomarkers of CTEPH were lower with CDT compared with ACA. At 3 months, both groups demonstrated similar biomarker levels, 6-minute walking distances, and quality-of-life scores.

Repeat angiography in patients undergoing conventional catheter-directed thrombolysis for submassive pulmonary embolism: a large single-center experience

Purpose Few studies have examined conventional catheter directed thrombolysis (CDT) for the treatment of submassive pulmonary embolism (PE). Moreover, angiographic resolution of thrombus burden following CDT has infrequently been characterized. This study describes a single-center experience treating submassive PE with CDT while utilizing repeat angiography to determine treatment efficacy. Methods A retrospective analysis of 140 consecutive patients who underwent CDT for submassive PE from December 2012 to June 2019 was performed. Angiographic resolution of thrombus burden after CDT was reported as high (>75%), moderate (51-75%), low (26-50%), or insignificant (≤25%). All angiograms were reviewed by two interventional radiologists. Secondary endpoints included reduction in pulmonary artery pressure (PAP) and clinical outcomes. Bleeding events were classified according to the Society of Interventional Radiology (SIR) adverse event criteria. Results CDT was performed in 140 patients with a mean rtPA dose of 25.3 mg and a mean treatment time of 26.0 hours. Angiographic resolution of thrombus burden was high in 70.0%, moderate in 19.3%, low in 5.7%, and insignificant in 3.6%; in 2 patients (1.4%) repeat angiography was not performed. Systolic PAP was reduced (47 vs. 35 mmHg, p Conclusion In patients with submassive PE undergoing CDT, angiographic resolution of thrombus burden is a safe and directly observable metric that can be used to determine procedural success. In this study, CDT with repeat angiography was associated with a 5.7% bleeding event rate and thirty-day mortality of 1.4%.

Fibrinogen Levels and Bleeding Risk in Patients Undergoing Ultrasound-Assisted Catheter-Directed Thrombolysis for Submassive Pulmonary Embolism

Fibrinogen Levels and Bleeding Risk in Patients Undergoing Ultrasound-Assisted Catheter-Directed Thrombolysis for Submassive Pulmonary Embolism

Low-dose thrombolysis for submassive pulmonary embolism

The role of thrombolysis in submassive pulmonary embolism (PE) is controversial due to the high risk of hemorrhage. This study aimed to evaluate the role of half-dose tissue-type plasminogen activator...

Randomized Trial Comparing Standard Versus Ultrasound-Assisted Thrombolysis for Submassive Pulmonary Embolism: TheSUNSET sPE Trial.

The aim of this trial was to determine whether ultrasound-assisted thrombolysis (USAT) is superior to standard catheter-directed thrombolysis (SCDT) in pulmonary arterial thrombus reduction for patients with submassive pulmonary embolism (sPE). Catheter-directed therapy has been increasingly used in sPE and massive pulmonary embolism as a decompensation prevention and potentially lifesaving procedure. It is unproved whether USAT is superior to SCDT using traditional multiple-side-hole catheters in the treatment of patients with pulmonary embolism. Adults with sPE were enrolled. Participants were randomized 1:1 to USAT or SCDT. The primary outcome was 48-hour clearance of pulmonary thrombus assessed by pre- and postprocedural computed tomographic angiography using a refined Miller score. Secondary outcomes included improvement in right ventricular-to-left ventricular ratio, intensive care unit and hospital stay, bleeding, and adverse events up to 90days. Eighty-one patients with acute sPE were randomized and were available for analysis. The mean total dose of alteplase for USAT was 19 ± 7mg and for SCDT was 18 ± 7mg (P=0.53), infused over 14 ± 6 and 14 ± 5 hours, respectively (P=0.99). In the USAT group, the mean raw pulmonary arterial thrombus score was reduced from 31 ± 4 at baseline to 22 ± 7 (P< 0.001). In the SCDT group, the score was reduced from 33 ± 4 to 23 ± 7 (P< 0.001). There was no significant difference in mean thrombus score reduction between the 2 groups (P=0.76). The mean reduction in right ventricular/left ventricular ratio from baseline (1.54 ± 0.30 for USAT, 1.69 ± 0.44 for SCDT) to 48 hours was 0.37 ± 0.34 in the USAT group and 0.59 ± 0.42 in the SCDT group (P=0.01). Major bleeding (1 stroke and 1 vaginal bleed requiring transfusion) occurred in 2 patients, both in the USAT group. In the SUNSET sPE (Standard vs. Ultrasound-Assisted Catheter Thrombolysis for Submassive Pulmonary Embolism) trial, patients undergoing USAT had similar pulmonary arterial thrombus reduction compared with those undergoing SCDT, using comparable mean lytic doses and durations of lysis.

Pragmatic Use of Catheter-Directed Thrombolysis in Venous Thromboembolism and a Comparative Evaluation With Traditional Therapies in Submassive Pulmonary Embolism

Background: Catheter-directed thrombolysis (CDT) is a novel treatment for venous thromboembolism (VTE). Limited data describe pragmatic use of CDT and compare CDT to other VTE therapies. Objective: Assess the use of CDT and comparatively evaluate CDT, anticoagulation, and systemic thrombolysis in submassive pulmonary embolism (PE). Methods: Retrospective, single-center, chart audit. Part 1 described all patients who received CDT for VTE. Part 2 matched patients with submassive PE who received CDT, heparin, or systemic thrombolysis and assessed length of stay (LOS), bleeding, all cause in-hospital mortality, and escalation of care. Results: For part 1, 70 CDT patients were identified; 42 with DVT and 28 with PE. ICU LOS was longer (2.5 ± 2.9 vs. 4.9 ± 8.4 days, p = 0.07), escalation of care more frequent (0% vs. 35.7%, p < 0.0001), and hospital mortality greater (2.4% vs. 21.4%, p = 0.014) in the PE group. For part 2, 21 CDT patients were matched to 21 heparin and 21 systemic thrombolysis patients. All CDT and tPA patients were admitted to the ICU versus only 6 (28.6%, p < 0.001) heparin patients. ICU LOS was significantly longer in the CDT group versus systemic tPA and systemic anticoagulation (80.7 ± 64.1 vs. 48.2 ± 27.7 vs. 24.9 ± 59.1 hours; p = 0.0048). More IVC filters and thrombectomies were performed in the CDT group. Conclusions: CDT is frequently used for both DVT and PE and requires ICU admission. Escalation of care is common when CDT is used for PE. For submassive PE, CDT is associated with prolonged ICU LOS compared to heparin or systemic thrombolysis. Resource utilization with CDT requires further evaluation.

What to Do When They’re Eating for Two? A Case of Catheter-Directed Thrombolysis for Submassive Pulmonary Embolism in Pregnancy

ABSTRACTA 33-year-old G7P0 female at 8 weeks gestation presented to the emergency department (ED) following a syncopal episode. She complained of chest pain and dyspnea, and had hemodynamic instability, which responded to intravenous fluids. Continued fluid resuscitation, supplemental oxygen, as well as therapeutic dose low molecular weight heparin (LMWH) were administered in the ED. Computed tomography (CT) pulmonary angiogram confirmed saddle pulmonary embolism (PE). After 12 h of continued chest pain and high oxygen requirements, a decision was made to use catheter-directed thrombolysis (CDT) involving alteplase with manual thrombus maceration in bilateral pulmonary arteries. There were no immediate hemorrhagic complications and follow-up fetal ultrasound demonstrated a normal viable intrauterine pregnancy. She clinically improved and was discharged on LMWH. Cesarean section was scheduled, and the patient delivered a healthy term infant at 37 weeks gestation without complications. Our case demonstrates that CDT may be a safe and effective treatment for submassive PE in pregnancy. RÉSUMÉUne femme âgée de 33 ans et enceinte de huit semaines (G7P0) se présente aux urgences à la suite d’un épisode syncopal. Elle se plaint de douleurs thoraciques et de dyspnée et présente une instabilité hémodynamique qui répond aux solutés intraveineux. Une réanimation liquidienne continue, une oxygénothérapie ainsi qu’une dose thérapeutique d’héparine de faible poids moléculaire sont administrées aux urgences. L’angiographie pulmonaire par tomodensitométrie confirme une embolie pulmonaire en selle. Après 12 heures de douleurs thoraciques continues et de besoins élevés en oxygène, on décide d’utiliser la thrombolyse dirigée par cathéter (TDC) à l’aide de l’altéplase avec macération manuelle du thrombus dans les artères pulmonaires bilatérales. Il n’y a pas eu de complications hémorragiques immédiates et le suivi échographique du fœtus a démontré une grossesse intra utérine normale et viable. Son état clinique s’est amélioré et elle a obtenu son congé sous héparine de faible poids moléculaire. Une césarienne a été planifiée et la patiente a accouché d’un enfant à terme et en bonne santé à 37 semaines de grossesse, sans complications. Notre cas démontre que la TDC peut être un traitement sûr et efficace de l’embolie pulmonaire submassive en cours de grossesse.

To Thrombolyse or Not to Thrombolyse: Two Years Experience of Thrombolysis of Sub-Massive Pulmonary Embolism in a District General Hospital.

AimsCurrent British Thoracic Society (BTS) guidelines only recommend thrombolysis of pulmonary embolism (PE) in patients who are haemodynamically compromised. Newer evidence suggests a mortality benefit for the thrombolysis of sub-massive PE with right ventricular strain. We wanted to assess the outcome and safety of thrombolysis in patients with sub-massive PE in a DGH.MethodsThe notes for patients with sub-massive PE and thrombolysis from a two-year period were reviewed. Evidence of right ventricular strain and myocardial necrosis based on bedside echocardiography, computed tomography (CT) scan and troponin T were indications for thrombolysis.ResultsA total of 22 patients had thrombolysis of PE in the study period (56±14 years). Fourteen patients were classified as sub-massive PE (55±15 years). Out of eight patients who had thrombolysis of massive PE (58±14 years), three were initially classified as sub-massive PE but deteriorated within the next 48 hours and became haemodynamically unstable. In all patients, the diagnosis was confirmed with a CT pulmonary angiography (CTPA).Mean troponin was 82 in the sub-massive PE group and 102 in the massive PE group. The clinical condition and haemodynamic of patients improved rapidly within a few hours after thrombolysis.Post-thrombolysis echocardiography was performed, 17 patients had normal right ventricles with normal pulmonary arterial pressures.ConclusionThrombolysis of sub-massive pulmonary embolism is feasible in a district general hospital and seems to be a safe procedure, particularly in younger patients. It results in rapid improvement in the clinical condition of patients with a small incidence of bleeding complications.

Catheter directed thrombolytic therapy and aspiration thrombectomy in intermediate pulmonary embolism with long term results.

Catheter directed thrombolysis (CDT) and thrombectomy represent well established techniques for the treatment of intermediate pulmonary embolism (IPE). The long-term effect of catheter directed thrombolysis of IPE is unknown. Clinical, interventional and echocardiographic data from 80 consecutive patients with IPE who were treated with CDT were evaluated. Primary end-points were technical success and major adverse events. Secondary end-points were cardiovascular mortality, all-cause mortality, clinical success, rate of bleeding complications, improvement in pulmonary pressure and echocardiography parameters. CDT completed with alteplase (10 mg bolus and 1 mg/h maintenance dose) through a pig-tail catheter for 24 h. After 24 h, control pulmonary angiography was performed. In total, 80 patients with a mean age of 59.0 ± 16.8 years were treated. CDT was successful after the first post-operative day in 72 (90%) patients, but thrombus aspiration and fragmentation was performed due to failed thrombolysis in 8 (10%) patients. Final technical and clinical success was reached in 79 (98.8%) and 77 (96.3%) patients, respectively. The mean CDT time in IPE was 27.8 ± 9.6 h. Invasive pulmonary pressure dropped from 57.5 ± 16.7 to 38.9 ± 13.5 (p < 0.001). A caval filter was implanted in 4 (5%) patients. The 1-year major adverse events and cardiovascular mortality rate was 4.0% and 1.4%, respectively. Access site complications (6 major and 6 minor) were encountered in 12 (16.2%) patients. Catheter directed thrombolysis in submassive pulmonary embolism had excellent results. However, additional mechanical thrombectomy was necessary in some patients to achieve good clinical outcomes.

Catheter-Directed Thrombolysis in Submassive Pulmonary Embolism and Acute Cor Pulmonale

Treatment of submassive (intermediate-risk) pulmonary embolism (PE), defined as hemodynamically stable with right ventricular (RV) dysfunction, showed lower in-hospital all-cause mortality with intravenous thrombolytic therapy than with anticoagulants, but at an increased risk of major bleeding. The present investigation was performed to test whether catheter-directed thrombolysis reduces mortality without increasing bleeding in submassive PE. This was a retrospective cohort study based on administrative data from the Nationwide Inpatient Sample. In 2016, 13,130 patients were hospitalized with PE and acute cor pulmonale, were stable, and treated with catheter-directed thrombolysis in 1,500 (11%) or anticoagulants alone in 11,630 (89%). Mortality was lower with catheter-directed thrombolysis than with anticoagulants in unmatched patients, 35 of 1,500 (2.3%) compared with 755 of 11,630 (6.5%; p <0.0001) and in matched patients, 30 of 1,260 (2.4%) compared with 440 of 6,910 (6.4%; p <0.0001). Time-dependent analysis showed catheter-directed thrombolysis reduced mortality if administered within the first 3 days. Patients with saddle PE treated with anticoagulants had lower mortality than non-saddle PE, 75 of 1,730 (4.3%) compared with 680 of 9,900 (6.9%; p < 0.0001) in unmatched patients and 45 of 1,305 (3.4%) compared with 395 of 5,605 (7.0%; p < 0.0001) in matched patients. Mortality was not lower with inferior vena cava filters either in those who received catheter-directed thrombolysis or those treated with anticoagulants. There were no fatal or nonfatal adverse events associated with catheter-directed thrombolysis. In conclusion, patients with submassive PE appear to have lower in-hospital all-cause mortality with catheter-directed thrombolysis administered within 3 days than with anticoagulants, and risks are low.

Cost-effectiveness microsimulation of catheter-directed thrombolysis in submassive pulmonary embolism using a right ventricular function model.

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.

Feasibility of ultrasound-assisted catheter-directed thrombolysis for submassive pulmonary embolism: A meta-analysis of case series.

During the past few years, there has been a surge in the use of ultrasound-assisted catheter-directed thrombolysis (UACDT) for submassive pulmonary embolism (SPE). However, few studies evaluated the feasibility of UACDT for SPE. To evaluate the feasibility of UACDT in treating SPE. A comprehensive search of online databases was performed. Search terms UACDT in SPE were entered into PubMed, Embase, Scopus and the Cochrane Library to identify related articles published until October 2018. A quality assessment and data extraction were performed by two researchers. Meta-analysis was performed using R statistical software. Twelve studies with 485 patients were included in this meta-analysis. The pooled right ventricular/left ventricular ratio decrease and pulmonary artery systolic pressure drop after treatment was -0.34 (95% CI: -0.43, -0.25) and -15.05 (95% CI: -18.10, -12.00) mm Hg, respectively. The pooled major bleeding rate was 1.0% (95% CI: 0.0%, 3.0%), and the in-hospital mortality was 0.0% (95% CI: 0.0%, 1.0%). This up to data meta-analysis confirms that UACDT is a feasible treatment for SPE.

Ultrasound-Accelerated, Catheter-Directed Thrombolysis for Submassive Pulmonary Embolism: Single-Center Retrospective Review with Intermediate-Term Outcomes

To evaluate ultrasound-accelerated, catheter-directed thrombolysis (CDT) for treatment of acute submassive pulmonary embolism (PE). This single-center, retrospective study included patients who underwent CDT for acute submassive PE (N= 113, 52% men/48% women) from 2013 to 2017. Baseline characteristics included history of deep venous thrombosis (12%), history of PE (6%), and history of cancer (18%). Of cohort patients, 88% (n=99) had a simplified PE severity index score of ≥ 1 indicating a high risk of mortality. A technical success rate of 100% was achieved with 84% of patients having bilateral catheter placements. Average tissue plasminogen activator (tPA) therapy duration was 20.7 hours ± 1.5, and median tPA dose was 21.5 mg. Three patients (2.6%) experienced minor hemorrhagic complications. Mean hospital length of stay was 6 days. Mean pulmonary arterial pressure decreased from 55 mm Hg on presentation to 37 mm Hg (P < .01) 1 day following initiation of thrombolytic therapy. All-cause mortality rate of 4% (n= 4) was noted on discharge, which increased to 6% (n= 7) at 6 months. At 6-month follow-up compared with initial presentation, symptom improvements (93%), physiologic improvements (heart rate 72 beats/min vs 106 beats/min, P < .01), oxygen requirement improvements (fraction of inspired oxygen 20% vs 28%, P < .01), and right ventricular systolic pressure improvements by echocardiography (30 mm Hg vs 47 mm Hg, P < .01) were observed. CDT for acute submassive PE was associated with low complications and mortality, decreased right ventricular systolic pressure, high rates of clinical improvement, and improved intermediate-term clinical outcomes.

Catheter-directed thrombolysis for submassive pulmonary embolism in children: A case series.

Incidence of venous thromboembolism, including pulmonary embolism (PE), continues to rise in children. Optimum management of submassive PE is unclear. The principal objective of this retrospective study was to investigate the radiological and clinical outcomes in children with submassive PE treated with catheter-directed thrombolysis (CDT). Five patients underwent six episodes of CDT. No patient developed major/clinically relevant non-major bleeding. Most patients had complete radiological thrombus resolution and no patient had evidence of chronic thromboembolic pulmonary hypertension. There is an urgent need for larger prospective cohort studies/randomized controlled trials to investigate the role of CDT in pediatric PE.

Thrombolysis for Submassive Pulmonary Embolism

Thrombolysis for Submassive Pulmonary Embolism

Tissue plasminogen activator dose and pulmonary artery pressure reduction in catheter directed thrombolysis of submassive pulmonary embolism.

PurposeThe 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 methodsRecords 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.ResultsMean 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.ConclusionIncreased total t-PA dose and CDT duration were associated with greater PAP reduction without increased bleeding events.

Catheter-Directed Thrombolysis for Submassive Pulmonary Embolism.

Acute pulmonary embolism (PE) is a leading cause of morbidity and mortality in the United States. PE associated with right ventricular strain, termed submassive or intermediate-risk PE, is associated with an increased rate of clinical deterioration and short-term mortality. Trials have demonstrated systemic thrombolytics may improve patient outcomes, but they carry a risk of major hemorrhage. Catheter-directed thrombolysis (CDT) may offer similar efficacy to and a lower risk of catastrophic hemorrhage than systemic thrombolysis. Three prospective trials have evaluated CDT for submassive PE; ULTIMA, SEATTLE II, and PERFECT. These trials provide evidence that CDT may improve radiographic efficacy endpoints in submassive PE with acceptable rates of major hemorrhage. However, the lack of clinical endpoints, long-term follow-up, and adequate sample size limit their generalizability. Future trials should be adequately powered and controlled so that the short- and long-term effectiveness and safety of CDT can be definitively determined.

4:03 PM Abstract No. 228 Ultrasound-assisted catheter-directed thrombolysis for submassive pulmonary embolism: efficacy in relief of right heart strain

To determine the outcomes, safety profile, and efficacy of ultrasound-assisted catheter-directed thrombolysis for pulmonary embolism with right heart strain. The charts of 30 consecutive patients who underwent CDT as treatment for pulmonary embolism were reviewed. Risk factors for bleeding were noted. Indicators of right heart strain on computed tomography and echocardiogram, as well as degree of pulmonary vascular obstruction, were recorded before and after CDT. Thirty-day mortality and occurrence of bleeding events were recorded. Right ventricular systolic pressure decreased from an average of 53.1 mm Hg to 38.5 mm Hg (p = <0.001) and average Qanadli index of pulmonary vascular obstruction decreased from 49 to 34 (p = <0.001) after CDT. The average ratio of RV/LV diameter decreased from 1.48 to 1.17 (p = <0.001) The number of patients with RV hypokinesis decreased significantly (p = 0.016) from 19 (95% of those with available data) to 12 (60%). The number of patients with RV dilation decreased significantly (p = 0.031) from 19 (95% of those with available data) to 13 (65%). Nine (30%) patients had three or more minor contraindications to thrombolysis and fourteen (47%) had had major surgery in the month prior to CDT. No patients experienced major or moderate bleeding attributed to CDT. In our experience CDT proved effective in the rapid alleviation of right heart strain with minimal bleeding risk. Right heart strain is associated with increased mortality and long-term morbidity in pulmonary embolism and CDT may allow for a safe means of improving outcomes in submassive pulmonary embolism. We found CDT to be a safe alternative to systemic thrombolysis in patients with risk factors for bleeding such as prior surgery.Tabled 1Measures of Right Heart Strain Before and After CDTPre-CDT MeanSDPost-CDT MeanSDDifference MeanSDP ValueRVSP53.115.138.510.214.512.6<0.001RV/LV1.480.321.170.260.322.16<0.001Qanadli Index4918341315.410.1<0.001 Open table in a new tab

Ultrasound-Assisted Catheter-Directed Thrombolysis for Submassive Pulmonary Embolism

Catheter-directed thrombolysis (CDT) is a relatively new therapy for pulmonary embolism that achieves the superior clot resolution compared to systemic thrombolysis while avoiding the high bleeding risk intrinsically associated with that therapy. In order to examine the efficacy and safety of CDT, we conducted a retrospective cohort study of patients undergoing ultrasound-assisted CDT at our institution. The charts of 30 consecutive patients who underwent CDT as a treatment of pulmonary embolism at our institution were reviewed. Risk factors for bleeding during thrombolysis were noted. Indicators of the right heart strain on computed tomography and echocardiogram, as well as the degree of pulmonary vascular obstruction, were recorded before and after CDT. Thirty-day mortality and occurrence of bleeding events were recorded. Nine (30%) patients had 3 or more minor contraindications to thrombolysis and 14 (47%) had major surgery in the month prior to CDT. Right ventricular systolic pressure and vascular obstruction decreased significantly after CDT. There was a significant decrease in the proportion of patients with right ventricular dilation or hypokinesis. Decrease in pulmonary vascular obstruction was associated with nadir of fibrinogen level. No patients experienced major or moderate bleeding attributed to CDT. Catheter-directed thrombolysis is an effective therapy in rapidly alleviating the right heart strain that is associated with increased mortality and long-term morbidity in patients with pulmonary embolism with minimal bleeding risk. Catheter-directed thrombolysis is a safe alternative to systemic thrombolysis in patients with risk factors for bleeding such as prior surgery. Future studies should examine the safety of CDT in patients with contraindications to systemic thrombolysis.

Design and rationale of a randomized trial comparing standard versus ultrasound-assisted thrombolysis for submassive pulmonary embolism.

Catheter-directed interventions for the treatment of patients with submassive pulmonary embolism (sPE) have shown promise in rapidly improving right-sided heart strain and preventing decompensation to massive pulmonary embolism. Among various catheter interventions, ultrasound-assisted thrombolysis (USAT) has attracted interest as potentially having more efficient lytic effect that could achieve thrombolysis faster and with a reduced lytic dose. However, based on clinical evidence, it is unclear whether USAT is superior to standard catheter-directed thrombolysis (SCDT). We herein describe the study design of the Standard vs UltrasouNd-assiSted CathEter Thrombolysis for Submassive Pulmonary Embolism (SUNSET sPE) trial, an ongoing randomized clinical trial designed to address this question. Adults with sPE presenting or referred to our institution are considered for enrollment in the trial. At the discretion of the treatment team, all patients undergo a catheter-directed intervention plus concomitant therapeutic anticoagulation. Participants are randomized 1:1 to a USAT catheter or an SCDT catheter. Study assessors are blinded to treatment group. The primary outcome is clearance of pulmonary thrombus burden, assessed by postprocedure computed tomography angiography. Secondary outcomes include resolution of right ventricular strain by echocardiography; improvement in pulmonary artery pressures; and 3- and 12-month improvement in echocardiographic, functional capacity, and quality of life measures. The study is powered to detect a 50% improvement in pulmonary artery thrombus clearance. Our enrollment target is 40 patients per treatment arm. SUNSET sPE is an ongoing randomized, head-to-head, single-blinded clinical trial with the goal of assessing whether USAT results in superior thrombus clearance compared with SCDT in patients with sPE. We expect the results ofour study to inform future guidelines on choice of thrombolysis modality in this population of challenging patients.