Additional Catheter-directed Thrombolysis Research Articles

Percutaneous mechanical thrombectomy using the Rotarex®S device for the treatment of acute lower limb artery embolism: A retrospective single-center, single-arm study.

Acute limb embolism (ALE) is a challenging, highly morbid, and frequently fatal vascular emergency. Percutaneous mechanical thrombectomy (PMT) devices are an alternative treatment to restore perfusion by removing emboli in the limb arterial system. We evaluated the outcomes of treatment of ALE patients using PMT devices in our center. A retrospective review of ALE patients treated with Rotarex S (Straub Medical) at a single institution from 2018 to 2022 was performed. The primary outcome was technical success, defined as complete recanalization of the occluded segment with satisfactory outflow and good capillary filling of the distal parts of the foot without any major or obstructing residual emboli or thrombi either in the treated segment or in the outflow tract without the need for additional catheter-directed thrombolysis (CDT) or conversion to open surgery. Embolized segments treated, treatment outcomes, and perioperative complications were reviewed. A total of 17 ALE patients (29% men, 71% women; mean age, 73 years) underwent PMT procedures. The femoral arteries and popliteal arteries are the most commonly treated vessels, with both present in 59% of the patients. The technical success rate was 100%, but the majority of cases (82%) had concurrent percutaneous transluminal angioplasty or stent grafting, and two patients were treated with urokinase during the operation. There was one thrombotic recurrence that required amputation. There were no 30-day deaths. Complications included extravasation after PMT (two), intraoperative embolization of the outflow tract (one), access site hematoma (one), target artery thrombosis (one), and acute kidney injury (one). There were no severe bleeding complications. The Rotarex S device has a satisfactory success rate, although complementary use of various adjunctive techniques is frequently required. It seems to be a moderately effective tool for treating ALE to avoid CDT or open surgery. The device appears safe, with low risks of amputation and mortality rates, but special attention should be given to the potential for extravasation and distal embolism.

Sex-related differences in the effect of rotational thrombectomy for thrombus-containing lower limbs ischemic lesions

BackgroundTo assess the immediate effect and factors affecting the efficacy of rotational thrombectomy (RT) in patients with thrombus-containing lower-limb ischaemic lesions.MethodsPatients were retrospectively divided into two groups: RT and RT+ CDT (Catheter-directed thrombolysis). The RT group included patients in whom intraoperative thrombus aspiration was successful, while the RT + CDT group included patients in whom intraoperative thrombus aspiration was less effective and remedial CDT treatment was used. The primary outcome was the immediate effect of RT on thrombus-containing lower-limb ischaemic lesions.ResultsFrom May 2015 to July 2021, 170 patients (113 men, 57 women; mean age, 74.0 years) with thrombus-containing lower-limb ischaemic lesions were treated in our centre. Of these patients, 113 received RT only, while 57 received RT + CDT. There were no significant intergroup differences in terms of age, disease duration, or comorbidities, but a higher proportion of male patients and higher preoperative plasma D-dimer levels (1.23 vs. 0.84; p = .017) was observed in the RT + CDT group. There were no significant intergroup differences in terms of diagnosis, lesion characteristics, lesion location, or lesion length. Multivariate logistic regression analysis revealed that male sex (odds ratio [OR], 2.65; 95% confidence interval [CI], 1.098–6.410; p = .030) and poor distal runoff (OR, 2.94; 95% CI, 1.439–5.988; p = .003) were associated with higher rates of additional CDT. Male patients also had a significantly longer onset time, more thrombotic occlusions, and a greater frequency of in-stent restenosis.ConclusionsRT alone or with CDT is a feasible primary treatment option for thrombus debulking. Sex significantly influences the effect of RT on thrombus-containing lower-limb ischaemic lesions.

Predictors of long-term post-thrombotic syndrome following high proximal deep vein thrombosis: a cross-sectional study

BackgroundPost-thrombotic syndrome (PTS) is a frequent chronic complication of proximal deep vein thrombosis (DVT) of the lower limb, but predictors of PTS are not well established. We aimed to examine predictors of PTS in patients with long-term PTS following proximal DVT.MethodsDuring 2006–09, 209 patients with a first time acute upper femoral or iliofemoral DVT were randomized to receive either additional catheter-directed thrombolysis or conventional therapy alone. In 2017, the 170 still-living participants were invited to participate in a cross-sectional follow-up study. In the absence of a gold standard diagnostic test, PTS was defined in line with clinical practice by four mandatory, predefined clinical criteria: 1. An objectively verified DVT; 2. Chronic complaints (> 1 month) in the DVT leg; 3. Complaints appeared after the DVT; and 4. An alternative diagnosis was unlikely. Possible predictors of PTS were identified with multivariate logistic regression.ResultsEighty-eight patients (52%) were included 8–10 years following the index DVT, and 44 patients (50%) were diagnosed with PTS by the predefined clinical criteria. Younger age and higher baseline Villalta score were found to be independent predictors of PTS, i.e., OR 0.96 (95% CI, 0.93–0.99), and 1.23 (95% CI, 1.02–1.49), respectively. Lack of iliofemoral patency at six months follow-up was significant in the bivariate analysis, but did not prove to be significant after the multivariate adjustments.ConclusionsIn long-term follow up after high proximal DVT, younger age and higher Villalta score at DVT diagnosis were independent predictors of PTS.

A CASE OF PHLEGMASIA CERULEA DOLENS AND MAY-THURNER SYNDROME IN A YOUNG MALE WITH TRIPLE-POSITIVE ANTIPHOSPHOLIPID ANTIBODY SYNDROME

SESSION TITLE: Medical Student/Resident Critical Care Posters SESSION TYPE: Med Student/Res Case Rep Postr PRESENTED ON: October 18-21, 2020 INTRODUCTION: Phlegmasia cerulea dolens (PCD) is an uncommon form of deep vein thrombosis (DVT) typically presenting with acute limb swelling, pain, and cyanosis. Diagnosis of PCD should be made promptly as these patients may develop limb-threatening complications such as gangrene and compartment syndrome. We describe a young male presenting with his first episode of provoked venous thromboembolism (VTE) as PCD complicated with May-Thurner syndrome (MTS) and Antiphospholipid antibody syndrome (APS). CASE PRESENTATION: A 37-year-old obese male with type 2 diabetes, hypertension, and hyperlipidemia was directly admitted to the medicine floor with extensive left lower extremity DVT (including ileofemoral vein thrombosis) found on outpatient duplex ultrasonography. At initial hospitalization, he was tachycardic but without respiratory distress or hemodynamic instability. His left lower extremity was tender and edematous with cyanosis. Diagnosis of PCD was made and patient was treated with subcutaneous enoxaparin. He received catheter-directed thrombolysis for PCD with alteplase and heparin infusion. During left leg venogram, he was discovered to have MTS, and subsequently underwent stent placement of left common iliac vein, external iliac vein, and common femoral vein. After stent placement, patient received bridging to warfarin with enoxaparin and was discharged home two days later. Patient’s family history was significant for Systemic Lupus Erythematosus. During hospitalization, his antibody testing revealed positivity for anti-cardiolipin, anti-beta-2 glycoprotein antibodies in addition to positive functional lupus anticoagulant assay. Positivity confirmed with repeat testing of anti-cardiolipin antibodies and lupus anticoagulant assay at 15 weeks after hospitalization - confirming the diagnosis of triple-positive APS. DISCUSSION: Treatment of PCD is anticoagulation therapy with adjunctive catheter-directed thrombolysis. Outcomes comparing additional catheter-directed thrombolysis versus anticoagulation alone have shown that combination treatment reduces the incidence of post-thrombotic syndrome in patients with acute iliofemoral DVT. Recognition of DVT associated with MTS is important as treatment includes stent placement to maintain venous outflow. Recognition of triple-positive APS is an indication for extended anticoagulation as this portends a high risk of recurrent VTE. Patient was discharged with warfarin therapy because the use of direct oral anticoagulation in patients with APS remains controversial. Recent studies showed increased risk of recurrent thrombosis, particularly in patients with APS who are triple-positive. CONCLUSIONS: We reported a case, 37 year old male with phlegmasia cerulea dolens and May-Thurner syndrome resulting from triple-positive antiphospholipid antibody syndrome. Reference #1: Casey ET, Murad MH, Zumaeta-garcia M, et al. Treatment of acute iliofemoral deep vein thrombosis. J Vasc Surg. 2012;55(5):1463-73 Reference #2: Haig Y, Enden T, Grøtta O, et al. Post-thrombotic syndrome after catheter-directed thrombolysis for deep vein thrombosis (CaVenT): 5-year follow-up results of an open-label, randomised controlled trial. Lancet Haematol. 2016;3(2):e64-71 Reference #3: Dufrost V, Risse J, Reshetnyak T, et al. Increased risk of thrombosis in antiphospholipid syndrome patients treated with direct oral anticoagulants. Results from an international patient-level data meta-analysis. Autoimmun Rev. 2018;17(10):1011-1021 DISCLOSURES: No relevant relationships by Waqas Adeel, source=Web Response No relevant relationships by Robert Decker, source=Admin input No relevant relationships by Shuisen Li, source=Web Response No relevant relationships by Preysi Patel, source=Web Response No relevant relationships by Chun Siu, source=Web Response

Aspiration thrombectomy for the management of acute deep venous thrombosis in the setting of venous thoracic outlet syndrome.

Objectives Venous thoracic outlet syndrome, known by the eponym Paget–Schroetter syndrome, is seen in healthy, young individuals with “effort-induced thrombosis.” Endovascular therapies, including catheter-directed thrombolysis, have been described in the acute management of the upper extremity deep venous thrombosis; however, we assessed the technical success of treating this entity using a mechanical aspiration thrombectomy system. Methods This was a multi-center retrospective review of patients with venous thoracic outlet syndrome with acute thrombosis treated with the Indigo continuous aspiration mechanical thrombectomy system. Charts from patients with venous thoracic outlet syndrome and acute deep venous thrombosis treated with this system at our institution along with three data sharing locations were reviewed for demographics, deep venous thrombosis risk factors, imaging modalities used for diagnosis, extent of axillosubclavian deep venous thrombosis, treatment details, adjunctive therapies, and complications. The primary outcome was technical success (resolution of >70% of thrombus). Results There were 16 patients (50% male) with a mean age of 33 years (range 17–69 years). Six patients had underlying venous thromboembolism risk factors including use of contraceptives ( n = 2), prior deep venous thrombosis ( n = 3), and known thrombophilia ( n = 1). Fifteen patients had complete venous occlusion, and the extent of venous involvement included subclavian ( n = 14), axillary ( n = 16), and brachial ( n = 7). The majority (81.25%) of patients were treated in a single setting, and technical success was achieved in all cases with the use of adjunctive therapies. Only three patients required additional overnight thrombolytic therapy. Conclusions The Penumbra Indigo system, often in combination with adjunctive catheter-directed thrombolysis and venoplasty, is a safe and effective device for the treatment of acute upper extremity deep venous thrombosis in the setting of Paget–Schroetter syndrome. No patients experienced central embolization or post-operative renal insufficiency. One-third of patients avoided any additional catheter-directed thrombolysis exposure, and technical success was achieved in all cases. A single bleeding complication was observed in a patient undergoing overnight adjunctive catheter-directed thrombolysis. All patients maintained patency until time of first rib resection.

Ultrasound-accelerated catheter-directed thrombolysis versus anticoagulation for the prevention of post-thrombotic syndrome (CAVA): a single-blind, multicentre, randomised trial

Early thrombus removal might prevent post-thrombotic syndrome by preserving venous function and restoring flow. Previous trials comparing additional catheter-directed thrombolysis to standard treatment showed conflicting outcomes. We aimed to assess the benefit of additional ultrasound-accelerated catheter-directed thrombolysis for the prevention of post-thrombotic syndrome compared with standard therapy in patients with iliofemoral deep-vein thrombosis. We did a multicentre, randomised, single-blind, allocation-concealed, parallel group, superiority trial in 15 hospitals in the Netherlands. Patients aged 18-85 years with a first-time acute iliofemoral deep-vein thrombosis and symptoms for no more than 14 days were randomly assigned (1:1) to either standard treatment with additional ultrasound-accelerated catheter-directed thrombolysis or standard treatment alone. Randomisation was done with a web-based automatic programme and a random varying block size (2-12), stratified by age and centre. Standard treatment included anticoagulant therapy, compression therapy (knee-high elastic compression stockings; 30-40 mmHg), and early ambulation. Additional ultrasound-accelerated catheter-directed thrombolysis was done with urokinase with a starting bolus of 250 000 international units (IU) in 10 mL NaCl followed by a continuous dose of 100 000 IU/h for a maximum of 96 h through the Ekos Endowave-system. Adjunctive percutaneous transluminal angioplasty, thrombosuction, or stenting was performed at the discretion of the physician who performed the intervention. The primary outcome was the proportion of patients with post-thrombotic syndrome at 12 months diagnosed according to the original Villalta criteria-a Villalta-score of at least 5 on two consecutive occasions at least 3 months apart or the occurrence of venous ulceration-and was assessed in a modified intention-to-treat population of all randomly assigned patients who passed screening and started treatment. The safety analysis was assessed in the same modified intention-to-treat population. This study is complete and is registered at ClinicalTrials.gov, NCT00970619. Between May 28, 2010, and Sept 18, 2017, 184 patients were randomly assigned to either additional ultrasound-accelerated catheter-directed thrombolysis (n=91) or standard treatment alone (n=93). Exclusion because of screening failure or early withdrawal of informed consent resulted in 77 patients in the intervention group and 75 in the standard treatment group starting allocated treatment. Median follow-up was 12·0 months (IQR 6·0-12·0). 12-month post-thrombotic syndrome occurred in 22 (29%) patients allocated to additional treatment versus 26 (35%) patients receiving standard treatment alone (odds ratio 0·75 [95% CI 0·38 to 1·50]; p=0·42). Major bleeding occurred in four (5%) patients in the intervention group, with associated neuropraxia or the peroneal nerve in one patient, and no events in the standard treatment group. No serious adverse events occurred. None of the four deaths (one [1%] in the intervention group vs three [4%] in the standard treatment group) were treatment related. This study showed that additional ultrasound-accelerated catheter-directed thrombolysis does not change the risk of post-thrombotic syndrome 1 year after acute iliofemoral deep-vein thrombosis compared with standard therapy alone. Although this trial is inconclusive, the outcome suggests the possibility of a moderate beneficial effect with additional ultrasound-accelerated catheter-directed thrombolysis. Further research is therefore warranted to better understand this outcome in the context of previous trials, preferably by combining the available evidence in an individual patient data meta-analysis. The Netherlands Organisation for Health Research and Development (ZonMw), Maastricht University Medical Centre, BTG-Interventional Medicine.

Anticoagulation alone versus combined catheter-directed thrombolysis and anticoagulation in treatment of acute ilio-femoral deep venous thrombosis

Background: It was found that 50% of patients with iliofemoral deep venous thrombosis (DVT) treated by anticoagulant alone and compression stocking developed post thrombotic syndrome (PTS). Accelerated removal of thrombus by thrombolytic agents may increase venous patency and prevent PTS. The objective of the study was to assess short-term efficacy of additional catheter directed thrombolysis (CDT) compared with standard anticoagulant therapy alone.Methods: Prospective, randomized, controlled study on 50 patients (18–75 years) with acute iliofemoral DVT and symptoms <21 days were randomized to receive additional CDT or standard anticoagulant therapy alone. After 6 months, vein patency and insufficiency (reflux) was assessed using duplex ultrasound by an investigator blinded to previous treatments.Results: Fifty patients were allocated additional CDT (n=25) or ACs alone (n=25). After CDT, grade III (complete) lysis was achieved in 17 (68%) and grade II (50%–90%) lysis in 5 patients (20%). One patient suffered major bleeding and two had clinically relevant bleeding related to the CDT procedure. After 6 months, iliofemoral patency was found in 17 (68%) in the CDT group vs. 8 (32%) controls, corresponding to an absolute risk reduction 36% (95% CI, p=0.002). Femoral venous insufficiency was found to be higher among the ACs group 11 patients (44%) vs. 7 patients (28%) in the CDT group.Conclusions: After 6 months, additional CDT increased iliofemoral patency from 32% to 68% and decreased venous insufficiency from 44% to 28%.

Systematic review with meta‐analysis: portal vein recanalisation and transjugular intrahepatic portosystemic shunt for portal vein thrombosis

Transjugular intrahepatic portosystemic shunt has been increasingly used in patients with portal vein thrombosis to obtain patency, but evidenced-based decisions are challenging. To evaluate published data on efficacy and safety of endovascular therapy in portal vein thrombosis. Systematic search of PubMed, ISI, Scopus, and Embase for studies (in English, until October 2017) reporting feasibility, safety, 12-month portal vein recanalisation, transjugular intrahepatic portosystemic shunt patency, and survival in patients with benign portal vein thrombosis undergoing endovascular treatment. An independent extraction of articles using predefined data fields and quality indicators was used; pooled analyses based on random-effects models; heterogeneity assessment by Cochran's Q, I2 statistic, subgroup analyses, and meta-regression. Thirteen studies including 399 patients (92% cirrhosis; portal vein thrombosis: complete 46%, chronic 87%, cavernous transformation 17%, superior mesenteric vein involvement 55%) were included. Transjugular intrahepatic portosystemic shunt was technically feasible in 95% (95% CI: 89%-98%) with heterogeneity (I2 =57%, P<0.001) explained by cavernous transformation. Major complications occurred in 10% (95% CI: 6.0%-18.0%; I2 =52%, P=0.55). Additional catheter-directed thrombolysis was associated with more complications compared to transjugular intrahepatic portosystemic shunt alone or plus thrombectomy (17.6% vs 3.3%). Twelve-month portal vein recanalisation was 79% (95% CI: 67%-88%; I2 =78%, P<0.01). Shunt patency at 12 months was 84% (95% CI: 76%-90%; I2 =62%, P<0.01). Overall 12-month survival rate was 89%, with no heterogeneity. Transjugular intrahepatic portosystemic shunt for portal vein thrombosis recanalisation was highly feasible, effective, and safe. Cavernous transformation was the main determinant of technical failure. Additional catheter-directed thrombolysis was associated with higher risk of severe complications.

Catheter Directed Thrombolysis in Treatment of Acute Iliofemoral Deep Venous Thrombosis : Determinants of Outcome

Background: Acute deep vein thrombosis (DVT) of the lower limbs occurs in about 1.0 person per 1000 population per year and is associated with substantial morbidity. Although anticoagulation effectively prevents thrombus extension, pulmonary embolism, death, and recurrence may occur. Moreover, many patients develop venous dysfunction resulting in post-thrombotic syndrome (PTS). PTS is associated with reduced individual health-related quality of life and a substantially increased economic burden.Hence, additional and more aggressive treatment, including systemic thrombolysis, thrombectomy, and catheter- directed thrombolysis (CDT), has been introduced to accelerate thrombus removal. Numerous studies suggest that additional CDT may provide highly effective clot lysis.There is little doubt that the overall benefit of thrombolysis depends on multiple factors, including predisposing risks, symptom duration, thrombus extension, and technical approaches and interventional success. Aim of the Work: This study aimed to define predictors of immediate and mid-long-term anatomic and clinical failures to guide patient selection and to set a standard for patient and physician expectations. Patients and Methods: This is a prospective observational cohort study that enrolled 20 patients (22 limbs) who presented to the Ain Shams University hospitals in the period from 7/2015 to 7/2017 with acute iliofemoral deep venous thrombosis (IFDVT) and fulfilled the inclusion criteria (mentioned below). Intrathrombus catheter directed thrombolysis (CDT) was done. Assessments of predictors of immediate periprocedural success was based on degree of clot lysis and resolution of symptoms and signs. Incidence of postthrombotic syndrome (PTS) was calculated at 6 months postoperative using Villalta score (≥5 vs <5). Results: During the study duration, 20 patients (22 limbs) were recruited. The mean age was 40.95 ± 12.35 years old, 11 patients (12 limbs) were women. The indication for CDT was severe progressive pain/swelling (18 limbs), and phlegmasia cerulea dolens (4 limbs). 5 patients (7 limbs) had IVC thrombosis at the initial venography. 5 limbs had balloon dilatation only while iliac stenting was done in 12 limbs. 15 patients received CDT for 48 hours while 5 patients (7 limbs) received CDT for 24 hours (mean duration of CDT was 1.68 days). As regards bleeding, only 2 cases of those who had CDT for 24 hours had bleeding, while bleeding occurred in 12 cases of those who had CDT for 48 hours. There were no recurrent DVT, intra or postoperative pulmonary embolism nor death within the study population till the end of the follow up period (6months). 6 months post intervention, 7 limbs were free of PTS (Villalta score < 5), 15 limbs had mild to moderate PTS, and no patients had severe PTS. The mean Villalta score was 5.14 ± 1.859. Conclusion: In our study, determinants of outcome following CDT for acute IFDVT were: 1) access site, 2) dose of thrombolytic agent used, 3) duration of thrombolysis, and 4) thrombus score at the end of the procedure. More studies should be done comparing not only the effect of CDT on incidence of PTS but also its effect on its severity (e.g. Villalta score) on short and long term.

A Blue Leg: An Interventional Approach to a Limb-Threatening Deep Vein Thrombosis

A Blue Leg: An Interventional Approach to a Limb-Threatening Deep Vein Thrombosis

Post-thrombotic syndrome after catheter-directed thrombolysis for deep vein thrombosis (CaVenT): 5-year follow-up results of an open-label, randomised controlled trial

Post-thrombotic syndrome is a common complication after acute proximal deep vein thrombosis (DVT) and is associated with reduced quality of life and a substantial cost burden. In the 2-year results of the CaVenT study, additional catheter-directed thrombolysis reduced the risk of post-thrombotic syndrome by 14% compared with conventional therapy, but did not affect quality of life. In this study we report results at the 5-year follow-up, aiming to assess whether findings for post-thrombotic syndrome and quality of life have persisted. Between Jan 3, 2006, and Dec 22, 2009, we recruited patients aged 18-75 years with a first-time high proximal leg DVT from 20 hospitals in the Norwegian southeastern health region. With sealed envelopes, participants were randomly assigned (1:1) to standard treatment with compression stockings and anticoagulants (control group) or to standard treatment plus catheter-directed thrombolysis with alteplase within 21 days from symptom onset. Pre-specified outcomes in this analysis were post-thrombotic syndrome at 5 years as assessed with the Villalta score and scores for quality of life at 5 years with EQ-5D and the disease-specific VEINES-QOL/Sym. Analyses were by intention to treat. The trial is registered with ClinicalTrials.gov, number NCT00251771. At 5 year follow-up (last date Oct 14, 2014), data were available for 176 patients (84% of the 209 patients originally randomised)--87 originally assigned to catheter-directed thrombolysis and 89 originally assigned to the control group. 37 patients (43%; 95% CI 33-53) allocated to catheter-directed thrombolysis developed post-thrombotic syndrome, compared with 63 (71%; 95% CI 61-79) allocated to the control group (p<0·0001), corresponding to an absolute risk reduction of 28% (95% CI 14-42) and a number needed to treat of 4 (95% CI 2-7). Four (5%) patients assigned to catheter-directed thrombolysis and one (1%) to standard treatment had severe post-thrombotic syndrome (Villalta score ≥ 15 or presence of an ulcer). Quality-of-life scores with either assessment scale did not differ between the treatment groups. Additional catheter-directed thrombolysis resulted in a persistent and increased clinical benefit during follow-up for up to 5 years, supporting the use of additional catheter-directed thrombolysis in patients with extensive proximal DVT. However, allocation to this therapy did not lead to better quality of life. The optimal endovascular thrombolytic approach needs further investigation. Southeastern Norway Regional Health Authority, the Research Council of Norway, University of Oslo, Oslo University Hospital.

Catheter-directed thrombolysis plus anticoagulation versus anticoagulation alone in the treatment of proximal deep vein thrombosis - a meta-analysis.

The aim of this meta-analysis was to compare the clinical outcomes of catheter-directed thrombolysis (CDT) plus anticoagulation with anticoagulation alone in patients with lower-extremity proximal deep vein thrombosis (DVT). We systematically searched Pubmed, Embase, and the Cochrane Library from inception to October, 2014. All randomized controlled trials (RCTs) and non-randomized studies comparing the clinical outcomes between additional CDT and anticoagulation alone were included. The primary outcomes were postthrombotic syndrome and major bleeding complications. The secondary outcomes included the iliofemoral patency rate, deep venous function, mortality, pulmonary embolism, and recurrent DVT. Three RCTs and 3 non-randomized studies were included. Compared with standard anticoagulation treatment, additional CDT was associated with a significantly higher rate of complete lysis within 30 days (OR = 91; 95 % CI 19.28 to 429.46), a higher rate of 6-month patency (OR = 5.77; 95 % CI 1.99 to 16.73), a lower rate of postthrombotic syndrome (OR = 0.4; 95 % CI 0.19 to 0.96), and a lower rate of venous obstruction (OR = 0.20; 95 % CI 0.09 to 0.44). More major bleeding episodes occurred in the CDT group (Peto OR 2.0; 95 % CI 1.62 to 2.62). CDT was not found to reduce mortality, pulmonary embolism, or recurrent DVT. Additional CDT therapy appeared to be more effective than standard anticoagulation treatment in improving the venous patency and preventing venous obstruction and postthrombotic syndrome. Caution should be taken when performing CDT given the increased risk of major bleeding. However, no evidence supported benefits of CDT in reducing mortality, recurrent DVT, or pulmonary embolism.

Catheter-Directed Thrombolysis Along with Mechanical Thromboaspiration versus Anticoagulation Alone in the Management of Lower Limb Deep Venous Thrombosis-A Comparative Study.

Catheter-directed thrombolysis (CDT) with assisted mechanical thrombolysis is now considered as the standard of medical care for deep vein thrombosis (DVT). The study was conducted to describe the immediate and long-term (6 months) safety and effectiveness of CDT in patient with lower limb DVT compared with the routine anticoagulation alone. All 12 to 85 years old patients with recent (0-8 weeks) DVT were included. In CDT group, thrombus was aspirated mechanically and streptokinase (STK) was given along with unfractionated heparin (UFH). After 6 months, deep venous patency and postthrombotic syndrome (PTS) was assessed by using duplex ultrasound and Villalta scale, respectively. Among 51 patients with completed data, 25 patients were allocated additional CDT given for a mean duration of 108 ± 32 hours and 26 patients were allocated standard treatment alone. Grade III (complete) lysis was achieved in 37% patients and grade II (50-90%) lysis in 63% of patients. Patients with partial lysis underwent percutaneous transluminal angioplasty and/or venous stenting. After 6 months, iliofemoral patency was found in 20 (80%) in the CDT group versus 7 (23%) in anticoagulation alone group (p < 0.01). PTS was seen in 5 (20%) in the CDT group versus 19 (77%) in anticoagulation alone group (p < 0.01). We conclude that CDT and conventional manual aspiration thrombectomy are an effective treatment for lower extremity DVT. STK infusion can be safely given up to 6 days. As addition of UFH can cause thrombocytopenia, so daily monitoring of complete blood counts is needed during CDT.

Residual rates of reflux and obstruction and their correlation to post-thrombotic syndrome in a randomized study on catheter-directed thrombolysis for deep vein thrombosis.

Deep vein thrombosis (DVT) often results in venous valvular incompetence and incomplete recanalization, followed by post-thrombotic syndrome (PTS). Treatment with additional catheter-directed thrombolysis (CDT) in patients with an iliofemoral DVT has been shown to reduce the frequency of PTS. The objective of this study was to assess the effect of CDT on venous reflux and patency and to identify possible predictors for the development of PTS. Open, multicenter, randomized, controlled clinical trial. Patients (18-75years) with a first-time iliofemoral DVT were randomized to receive conventional treatment with anticoagulation and compression stockings or CDT in addition to conventional treatment. Follow-up after 6 and 24months included ultrasound and air plethysmography for evaluation of venous reflux and patency. PTS was assessed with the Villalta score. Possible predictors of PTS were analyzed in multivariate logistic regression models. Following additional CDT, deep venous reflux was detected in 65.2% (95% confidence interval [CI], 54.8-74.2) of patients at 6months and 66.7% (95% CI, 56.4-75.6) at 24months. The absolute risk reduction of deep venous reflux was 11.9% (95% CI, 1.1-24.9) after 6months and 16.5% (95% CI, 4.2-28.8) after 24months in the CDT arm compared with controls. Correspondingly, venous patency was regained in 65.9% (95% CI, 55.5-75.0) of patients at 6months and 74.7% (95% CI, 64.9-82.6) after 24months. Patency was regained in 18.5% (95% CI, 4.4-32.6) more patients after 6months and 15.1% (95% CI, 1.8-28.5) more patients after 24months compared with controls. Independent of treatment allocation, patients with fully recanalized and competent deep veins at 6-month follow-up had a 40.5% (95% CI, 26.4-54.7) absolute risk reduction of developing PTS compared with patients with abnormal vein assessment. Reflux and lack of patency at 6months were found to be independent predictors of PTS development in patients treated with CDT (odds ratio, 8.3; 95% CI, 2.6-26.8 for patients with reflux, and odds ratio, 0.17; 95% CI, 0.06-0.49 for patients with patency). Additional CDT improved patency and reduced reflux. Both parameters were found to be strong predictors of PTS in patients treated with CDT. Noninvasive vein assessments of patency and reflux may be helpful to identify and monitor patients at high risk of PTS. Our findings provide evidence for the importance of early recanalization with CDT for acute iliofemoral DVT.

Symptom burden and job absenteeism after treatment with additional catheter-directed thrombolysis for deep vein thrombosis

IntroductionAdditional catheter-directed thrombolysis (CDT) for acute deep vein thrombosis (DVT) reduces long-term postthrombotic syndrome and is likely to represent a cost-effective alternative treatment compared to the standard treatment of anticoagulation and elastic compression stockings. Accelerated thrombus resolution has also been suggested to improve symptoms and patient function in the acute phase. We aimed to investigate whether additional CDT led to fewer symptoms and job absenteeism during the first 6 months after initiation of DVT treatment compared to standard treatment alone.MethodsThe Catheter-directed Venous Thrombolysis (CaVenT) study was a multicenter open label, randomized controlled trial of patients ages 18 years to 75 years with a verified high proximal DVT, <21 days of symptoms, and no apparent bleeding risk. Patients were allocated to additional CDT or to standard treatment only. Symptoms were assessed at baseline and at 6 months using items from the generic and disease-specific quality of life questionnaires EQ-5D and VEINES-QOL/Sym, respectively. Individual data on sickness benefits related to venous thromboembolic disease were obtained from the national welfare service.ResultsA total of 90 patients allocated additional CDT and 99 control patients completed long-term follow-up and were included in the analyses. Twenty-four in the CDT arm and 40 controls received sick leave (P = 0.046). When considering working patients only (54 in the CDT arm and 72 controls) this difference was no longer statistically significant. Mean duration of job absenteeism was 86.4 days (95% confidence interval 59.4–113.5) in the CDT arm and 60.1 days (95% confidence interval 42.3–77.8) in controls (P = 0.072). After 6 months, more controls experienced frequent swelling of the leg compared with those allocated to CDT (47 [49.0%] patients versus 25 [29.4%] patients, respectively, [P = 0.007]).ConclusionThere are limitations to our data, but the findings indicate improved symptom relief and less frequent job absenteeism in patients treated with additional CDT; this expands upon previously established benefits from this treatment.

Health-related quality of life after catheter-directed thrombolysis for deep vein thrombosis: secondary outcomes of the randomised, non-blinded, parallel-group CaVenT study

ObjectivesTo investigate whether additional catheter-directed thrombolysis (CDT) improves long-term quality of life (QOL) compared with standard treatment with anticoagulation and compression stockings alone in patients with proximal deep vein thrombosis...

Cost-effectiveness of additional catheter-directed thrombolysis for deep vein thrombosis

Additional treatment with catheter-directed thrombolysis (CDT) has recently been shown to reduce post-thrombotic syndrome (PTS). To estimate the cost effectiveness of additional CDT compared with standard treatment alone. Using a Markov decision model, we compared the two treatment strategies in patients with a high proximal deep vein thrombosis (DVT) and a low risk of bleeding. The model captured the development of PTS, recurrent venous thromboembolism and treatment-related adverse events within a lifetime horizon and the perspective of a third-party payer. Uncertainty was assessed with one-way and probabilistic sensitivity analyzes. Model inputs from the CaVenT study included PTS development, major bleeding from CDT and utilities for post DVT states including PTS. The remaining clinical inputs were obtained from the literature. Costs obtained from the CaVenT study, hospital accounts and the literature are expressed in US dollars ($); effects in quality adjusted life years (QALY). In base case analyzes, additional CDT accumulated 32.31 QALYs compared with 31.68 QALYs after standard treatment alone. Direct medical costs were $64,709 for additional CDT and $51,866 for standard treatment. The incremental cost-effectiveness ratio (ICER) was $20,429/QALY gained. One-way sensitivity analysis showed model sensitivity to the clinical efficacy of both strategies, but the ICER remained < $55,000/QALY over the full range of all parameters. The probability that CDT is cost effective was 82% at a willingness to pay threshold of $50,000/QALY gained. Additional CDT is likely to be a cost-effective alternative to the standard treatment for patients with a high proximal DVT and a low risk of bleeding.

Percutaneous Right Ventricular Assist Device for Massive Pulmonary Embolism

The strategies for management of massive pulmonary embolism (PE) are diverse, and limited by a paucity of data from randomized controlled trials. Institutional preferences shape management of massive PE, with most institutions selecting between surgical embolectomy and systemic thrombolysis. In addition, systemic thrombolytics may be used in conjunction with, or substituted by, catheter-directed approaches including thrombectomy, fragmentation, directed thrombolysis, and ultrasound-assisted thrombolysis. In patients who fail to respond to first line interventions and develop refractory cardiogenic shock secondary to right ventricular (RV) failure, options for escalation of care are limited. Sparse case reports suggest managing refractory RV failure from PE with peripheral extracorporeal membrane oxygenation, 1–3 whereas another case report describes the use of a surgically placed right ventricular assist devices (RVAD) after surgical embolectomy. 4 Here we describe a patient with persistent cardiogenic shock and RV failure after a massive PE despite treatment with systemic thrombolysis, who was rescued with the percutaneous placement of an RVAD followed by additional catheter-directed thrombolysis. A 48-year-old man with recent abdominal surgeries, including an ileocolostomy 1 month prior to presentation, had a witnessed syncopal event at home. The patient was found in the field to be unresponsive, with a systolic blood pressure of 70 mm Hg. On arrival to the hospital, the patient had regained consciousness, although his systolic blood pressure remained <75 mm Hg. An electrocardiogram on arrival showed sinus tachycardia at a rate of 110 bpm and a new right bundle branch block. A computed tomography angiogram showed extensive thrombus within the distal main pulmonary arteries (PA) bilaterally, extension of the clot into the segmental upper and lower bilateral pulmonary arteries, and an RV to left ventricle ratio of 1.7 (Figure 1). A bedside echocardiogram revealed an under-filled left ventricle, a normal left ventricular ejection fraction, and a severely enlarged RV with significant impair ment in global RV systolic function (Figure 2). His initial treatment included intravenous heparin, multiple vasoactive medications, and fluid resuscitation. He was deemed to be a poor candidate for surgical embolectomy. Catheter-based thrombectomy procedures were considered but systemic thrombolysis was chosen as the first therapeutic intervention. The patient received 100 mg of intravenous alteplase over 2 hours. Despite thrombolysis, the patient developed progressive acidemia with a pH of 6.98 and hypotension despite support with 4 vasoactive agents. Although arterial oxygenation remained stable, there was clinical evidence and laboratory evidence of hypoperfusion, including cool extremities, rising creatinine, and an elevated lactic acid, consistent with refractory shock. The patient underwent a right heart catheterization that showed severely elevated filling pressures with an RA pressure of 19 mm Hg, and PA pressures of 53/28 mm Hg. Pulmonary angiography revealed that after systemic thrombolysis, much of the proximal thrombus seen on computed tomography had moved distally. A bedside venous ultrasound and an intraprocedural iliac venogram showed patent common femoral and iliac veins. RV support was accomplished by placing a

Catheter-directed thrombolysis reduced the postthrombotic syndrome in acute iliofemoral DVT

Source Citation Enden T, Haig Y, Klow NE, et al; CaVenT Study Group. Long-term outcome after additional catheter-directed thrombolysis versus standard treatment for acute iliofemoral deep vein thro...

Long-term Outcome After Additional Catheter-Directed Thrombolysis Versus Standard Treatment for Acute Iliofemoral Deep Vein Thrombosis (the CaVen T Study): A Randomised Controlled Trial

Long-term Outcome After Additional Catheter-Directed Thrombolysis Versus Standard Treatment for Acute Iliofemoral Deep Vein Thrombosis (the CaVen T Study): A Randomised Controlled Trial