Cost Effectiveness of Early Endovenous Thrombus Removal for Acute Iliofemoral Deep Vein Thrombosis in the United Kingdom.

OBJECTIVE: Early clot removal using endovascular intervention aims to reduce post-thrombotic syndrome (PTS) following iliofemoral deep venous thrombosis (DVT). This may reduce long term morbidity but incurs a higher initial cost. This study examined the cost effectiveness of catheter directed thrombolysis (CDT) and pharmacochemical thrombectomy (PMT) compared with oral anticoagulation (OAC) alone for treatment of acute iliofemoral DVT in the United Kingdom. METHODS: A combined decision tree (acute DVT complications) and Markov model (long term complications [PTS]) was used for decision analytic modelling with five states: no PTS, mild PTS, moderate PTS, severe PTS, and dead. All patients started with acute DVT. Patients who survived acute complications transitioned into the Markov model. Cycle time was six months. A healthcare payer perspective and lifetime horizon was used, adjusting for excess mortality due to history of thrombosis. Data for probabilities, transition probabilities, mortality, and utilities were obtained from the published literature. Cost data were obtained from UK NHS tariffs and published literature. Outcomes were mean lifetime cost, quality adjusted life years (QALYs), and cost effectiveness. RESULTS: Over a patient's lifetime, OAC was more costly (£37 206) than CDT (£32 043) and PMT (£36 288). Mean lifetime QALYs for OAC (12.9) were lower than CDT (13.5) and PMT (13.3). Therefore, in the incremental cost effectiveness analysis, both CDT and PMT were dominant: CDT was less costly (-£5 163) and more effective (+0.6 QALYs) than OAC, and PMT was also less costly (-£917) and more effective (+0.3 QALYs) than OAC. Results were robust to univariable sensitivity analyses, but probabilistic sensitivity analyses suggested considerable parameter uncertainty. CONCLUSION: Early interventional treatment of iliofemoral DVT is cost effective in the UK. Future clinical and epidemiological studies are needed to characterise parameter uncertainty. Further analysis of modern practice, alternative treatments, and optimised care models is warranted.

Central Venous Catheter as a Novel Approach to Postoperative Thrombolysis in Patients with Acute Iliofemoral Deep Venous Thrombosis.

BACKGROUND AND AIMS: Percutaneous mechanical thrombectomy (PMT) along with postoperative thrombolysis (POT) has been the standard treatment for acute iliofemoral deep venous thrombosis (IFDVT). However, commonly used catheter directed thrombolysis (CDT) approaches for POT carry certain disadvantages, including the need for a sheath, inferior comfortability, and catheter-related complications. Therefore, we propose a new simplified method of POT using a central venous catheter (CVC). METHODS: The retrospective study analyzed patients with IFDVT who underwent POT using CVC from January 2020 to August 2021. The treatment modalities included filter placement, thrombus removal, iliac vein obstruction release, postoperative CVC thrombolysis, filter retrieval, and adequate full course anticoagulation. RESULTS: A total of 39 patients were included in this retrospective study. All patients underwent PMT surgery with a procedure success rate of 100%. In the post-PMT CVC thrombolysis, the puncture sites were located in the below-knee vein, including 58.97% in the peroneal vein. The mean duration of CVC-directed thrombolysis was 3.69 ± 1.08 days, and the total urokinase dose was 2.27 ± 0.71 MIU. A total of 37 patients (94.87%) had successful thrombolysis with a length of hospital stay of 5.82 ± 2.21 days. During CVC-directed thrombolysis, only four minor bleeding complications occurred, two of which were indwelling catheter-related. During the 12-month follow-up period, the patency rate and post-thrombotic syndrome incidences were 97.44% and 2.56%, respectively. CONCLUSION: Thrombolysis through a CVC is a feasible, safe, and effective POT method, and could be an alternative to the conventional CDT approach for patients with IFDVT.

Exploration of risk factors for hemoglobinuria and acute kidney injury following iliofemoral venous mechanical thrombectomy.

Objective: To evaluate the risk factors for hemoglobinuria and acute kidney injury (AKI) after percutaneous mechanical thrombectomy (MT) with or without catheter-directed thrombolysis (CDT) for iliofemoral deep vein thrombosis (IFDVT). Methods: Patients with IFDVT who had MT with the AngioJet catheter (group A), MT plus CDT (group B), or CDT alone (group C) from January 2016 to March 2020 were retrospectively evaluated. Hemoglobinuria was monitored throughout the treatment course, and postoperative AKI was assessed by comparing the preoperative (baseline) and postoperative serum creatinine (sCr) levels from the electronic medical records of all patients. AKI was defined as an elevation in the sCr level exceeding 26.5 â€‹µmol/L within 72 â€‹h after the operation according to the Kidney Disease Improving Global Outcomes criteria. Results: A total of 493 consecutive patients with IFDVT were reviewed, of which 382 (mean age, 56 â€‹± â€‹11 years; 41% of them were females; 97 in group A, 128 in group B, and 157 in group C) were finally analyzed. Macroscopic hemoglobinuria was evident in 44.89% of the patients of the MT groups (101/225, 39 in group A, and 62 in group B), with no significant difference between the groups (P â€‹= â€‹0.219), but not in the patients in group C. None of the patients developed AKI (mean sCr difference -2.76 â€‹± â€‹13.80 â€‹µmol/L, range â€‹= â€‹-80.20 to 20.60 â€‹µmol/L) within 72 â€‹h after surgery. Conclusions: Rheolytic MT is an independent risk factor for hemoglobinuria. A proper aspiration strategy, hydration, and alkalization following thrombectomy are particularly favorable for preventing AKI.

Improvement following restoration of inline flow argues against comprehensive thrombus removal strategies and for selective stenting in acute symptomatic iliofemoral venous thrombosis.

OBJECTIVE: Randomized trials have demonstrated the benefit of thrombus removal strategies in iliofemoral deep venous thrombosis (IFDVT) in providing early symptom relief and decreasing the incidence of post-thrombotic syndrome (PTS), especially severe PTS. However, the impact of quantum of residual thrombus burden (RTB) on PTS as determined by intravascular ultrasound examination and the role of venous stenting in the acute setting have not been evaluated and represent the focus of this study. METHODS: Sixty-nine limbs (65 patients) undergoing thrombus removal for acute symptomatic IFDVT between 2015 and 2021 formed the study cohort. The Venous Clinical Severity Score (VCSS) (range, 0-27) grade of swelling (GOS) (range, 0-4), and visual analog scale (VAS) pain scores (range, 0-10) were evaluated initially and at 6, 12, and 24 months after thrombus removal. Quality of life was appraised using the CIVIQ-20 instrument. The extent of initial and RTB after the intervention was estimated using intravascular ultrasound examination. Grading was done as less than 50% (1), 50% to 99% (2), or 100% (3) of luminal thrombus fill within each segment (common femoral vein, external iliac vein, and common iliac vein) by a blinded rater and then combined to generate a total score. The use of stenting, both concurrent (severe residual stenosis/persistent occlusion) and delayed (quality of life impairing residual or recurrent symptoms), was evaluated. RESULTS: Of the 69 limbs, 53 underwent pharmacomechanical/mechanical thrombectomy (PMT), whereas 16 patients underwent PMT and catheter-directed thrombolysis with restoration of inline flow in all limbs. Post-intervention VCSS improved from 6 to 2 at 24 months (P < .0001). GOS improved from 4 to 0 at 24 months (P < .0001). The VAS pain score went from 5 to 0 at 6 months (P < .0001) and remained at 0 at 12 months (P < .0001), but increased to 3 at 24 months (P = .02). The CIVIQ-20 score improved from 38 to 22 (P = .001) over a median follow-up of 19 months. The median RTB total score improved from 9 to 4 (P < .0001). There was no impact of RTB total score (<3 vs >3) on VCSS (P = NS), GOS (P = NS), VAS pain score (P = NS) or CIVIQ-20 score (P = NS) at the various time points. Concurrent stenting was used in 23 limbs (33%) and delayed stenting was carried out in 10 limbs (14%). The median time to delayed stenting was 4 months after the initial thrombus removal intervention. CONCLUSIONS: In patients undergoing PMT or PMT with catheter-directed thrombolysis for acute symptomatic IFDVT, the restoration of inline flow seems to be adequate to provide symptom relief and decrease the incidence of PTS. The extent of RTB does not seem to impact the VCSS, GOS, VAS pain score, or quality of life after such restoration. Stenting can be pursued selectively in the acute setting to help restore inline flow.

Outcomes of endovascular venous stenting in patients on direct oral anticoagulants and antiplatelet therapy at a tertiary referral center.

BACKGROUND: Endovenous revascularization is the standard in the management of acute thrombotic, chronic post-thrombotic iliocaval or iliofemoral obstruction, and nonthrombotic iliac vein lesions. The purpose of this study is to describe our single-center experience of postprocedure anticoagulation and antiplatelet regimens used after endovenous revascularization for a variety of venous occlusive conditions. METHODS: We conducted a retrospective analysis of 100 consecutive patients who underwent endovenous stenting for iliocaval or iliofemoral obstruction from January 1, 2014, to April 30, 2018. Patients treated with direct oral anticoagulants, warfarin, or low-molecular-weight heparin (LMWH) with or without antiplatelet therapy were identified. Demographic, procedural, patency, and follow-up data were collected. Stent patency was evaluated using duplex Doppler ultrasound examination or contrast venography. RESULTS: Seventy-one of 100 patients were treated with direct oral anticoagulant therapy (DOAC). Sixteen (23%) were lost to follow-up, leaving 55 (77%) available for analysis. The mean follow-up was 14 months (range, 1-43 months) with 32 patients (58%) followed for 12 months or longer. Primary, primary-assisted, and secondary-assisted patency rates were 87%, 97%, and 98%, respectively, at 12 months. In the non-DOAC group (patients treated with warfarin or LMWH), these rates were 87%, 93%, and 95%, respectively, at 12 months. Antiplatelet therapy, including clopidogrel, aspirin, or both, was used in 53 of 55 patients in the DOAC cohort and 18 of 19 patients in the non-DOAC group. CONCLUSIONS: Our-single center retrospective analysis demonstrates acceptable primary patency rates when using DOAC therapy compared with those treated with warfarin or LMWH.

Endovascular mechanical thrombectomy versus thrombolysis in patients with iliofemoral deep vein thrombosis - a systematic review and meta-analysis.

Background: This study sought to compare effectiveness and safety of percutaneous mechanical thrombectomy (PMT) and thrombolysis alone (THR) in patients with acute or subacute iliofemoral deep vein thrombosis (IfDVT). Patients and methods: Observational and randomized trials, published between January 2001 to February 2019 were identified by searching MEDLINE. Studies on deep venous thrombosis (DVT) treated with either THR or PMT adjunctive to conventional anticoagulation and compressive intervention were included. Meta-analysis of proportions was conducted to assess effectiveness outcomes of successful lysis and primary patency, post-thrombotic syndrome (PTS), valvular reflux, recurrent DVT, as well as safety outcomes of major bleeding, hematuria, and pulmonary embolism. Results: Of 77 identified records, 17 studies including 1417 patients were eligible. Pooled proportion of successful lysis was similar between groups (THR: 95 % [I2 = 68.4 %], PMT 96 %, [I2 = 0 %]; Qbet [Cochran's Q between groups] 0.3, p = 0.61). However, pooled proportion of 6-month primary patency was lower after THR than after PMT (68 % [I2 = 15.6 %] versus 94 %; Qbet 26.4, p < 0.001). Considerable heterogeneity within groups did not allow for between-group comparison of PTS and recurrent DVT. Major bleeding was more frequent after THR than after PMT (6.0 % [I2 = 0 %] versus 1.0 % [I2 = 0 %]; Qbet 12.3, p < 0.001). Incidence of hematuria was lower after THR as compared to PMT (2 % [I2 = 56 %] versus 91.3 % [I2 = 91.7 %]; Qbet 714, p < 0.001). Incidences of valvular reflux and pulmonary embolism were similar across groups (THR: 61 % versus PMT: 53 %; Qbet 0.7, p = 0.39 and THR: 2 % versus PMT: 1 %; Qbet 1.1, p = 0.30, respectively). Conclusions: In patients with iliofemoral DVT, percutaneous mechanical thrombectomy was associated with a higher cumulative 6-month primary patency and a lower incidence of major bleeding compared to thrombolysis alone. Risk of hemolysis from mechanical thrombectomy needs further consideration.

AngioJet Pharmacomechanical Thrombectomy and Catheter Directed Thrombolysis vs. Catheter Directed Thrombolysis Alone for the Treatment of Iliofemoral Deep Vein Thrombosis: A Single Centre Retrospective Cohort Study.

OBJECTIVE: Percutaneous thrombus removal is used for the treatment of iliofemoral deep vein thrombosis (DVT), but the efficacy of different treatment modalities has not yet been determined. The aim of this study was to compare the outcomes of patients treated with additional AngioJet pharmacomechanical thrombectomy (PCDT) vs. catheter directed lysis (CDT) alone. METHODS: A retrospective review of all patients who received thrombolysis for the treatment of symptomatic acute iliofemoral DVT between 2011 and 2017 was carried out. Outcome measures included the incidence of post-thrombotic syndrome (PTS), procedural outcomes (lytic exposure), the incidence of complications, and vessel patency. All patients were followed up for a minimum of one year. RESULTS: A total of 151 limbs were treated, 70 limbs with PCDT and 81 limbs with CDT alone. Demographic data and prevalence of risk factors were comparable. Incidence of PTS (Villalta score at one year) showed no significant difference (22.2% PCDT vs. 24.7% CDT alone, p = .74). Use of PCDT resulted in a non-statistically significant trend for fewer bleeds (n = 4/63 [6.3%] vs. 13/76 [17.1%]; relative risk 0.37, 95% confidence interval [CI] 0.13-1.08; p = .07), a statistically significant reduction in lysis duration (40 h [95% CI 34-46] vs. 53 h [95% CI 49-58]; p < .001) and a reduction in lytic dose (49 mg [95% CI 42-55] vs. 57 mg [95% CI 52-61]; p = .011) compared with CDT. This reduction was accentuated in 24 cases primarily treated with AngioJet PowerPulse mode (27 h, 95% CI 20-34 [p < .001] and 42 mg, 95% CI 34-50 [p = .009]). Incidences of complications were comparable between groups, with one death due to an intracranial haemorrhage following CDT. Although the incidence of haemoglobinuria was increased following PCDT (12/63 [19.0%] vs. 3/76 [3.9%]; p = .006), no significant difference in acute kidney injury was observed (3/63 [4.8%] vs. 1/76 [1.3%]; p = .33). No significant difference in vessel patency over two years was observed (p = .73). CONCLUSION: The use of PCDT for the treatment of iliofemoral DVT was observed to provide comparable patient outcomes, comparable vessel patency, an acceptable safety profile, and reduced overall lytic dose.

Posterior tibial vein approach to catheter-directed thrombolysis for iliofemoral deep venous thrombosis.

OBJECTIVE: Deep venous thrombosis (DVT) remains a significant cause of morbidity in the American population. Catheter-directed thrombolysis for acute iliofemoral DVT is an effective therapy not only to restore venous patency but also to reduce the development of post-thrombotic syndrome (PTS), especially in patients with extensive thrombosis involving the iliac and femoral venous segments. We hypothesized that delivery of thrombolytics through an access site in a vein distal to the segments containing thrombus would provide the greatest short- and long-term therapeutic clinical benefit with similar safety and efficacy. METHODS: All patients treated at a single institution between 2009 and 2016 undergoing mechanical and chemical thrombolysis for iliofemoral DVT were retrospectively reviewed. Patients were divided into groups by access site, including contralateral and ipsilateral femoral vein, popliteal vein, and posterior tibial vein (PTV). Preoperative demographics, intraoperative data, and postoperative outpatient charts were analyzed. Primary end points included evidence of incompetence after the procedure by duplex ultrasound assessment and development of complications of PTS as defined by the Villalta scale. RESULTS: Fifty-eight patients underwent mechanical and chemical thrombolysis, and 51 patients met the inclusion criteria. Thrombolysis access was through PTV (n = 27), popliteal vein (n = 20), or femoral vein (n = 4). More patients were female (55%), and the mean age was 57 years. Forty patients had unilateral DVT, whereas 11 patients had bilateral involvement. After lysis, 44 patients underwent percutaneous venous angioplasty and 11 patients underwent venous stenting in the acute setting. Although not statistically significant, mean operative times were slightly longer in the posterior tibial approach (156.7 minutes vs 130.6 minutes; P = .08), and mean fluoroscopy time was higher in the posterior tibial group (18.1 minutes vs 14.3 minutes; P = .17). Overall 90-day morbidity was 9.8%, and no deaths were recorded. Patency of the deep venous system was similar between the posterior tibial and the popliteal or femoral approach (95% vs 88%; P = .29); 21.6% developed symptoms of PTS. There was no difference for development of PTS between posterior tibial and popliteal or femoral approaches (22% vs 20.8%; P = .52). There was no difference in development of chronic nonocclusive DVT (37% vs 35%; P = .61). Median follow-up was 8.7 months (range, 0.4-58.9 months). CONCLUSIONS: The PTV approach to catheter-directed thrombolysis is a safe and sensible option for the treatment of iliofemoral and femoropopliteal DVT. A larger cohort will be necessary to demonstrate superiority of tibial vein access in the treatment of iliofemoral DVT with popliteal involvement.

[Endovascular treatment of acute iliofemoral deep venous thrombosis - our results with catheter-directed thrombolysis and AngioJet]. / Az akut proximális mélyvénás thrombosis endovascularis kezelése ­ a lokális katéteres lysissel és az AngioJet-tel szerzett tapasztalataink.

INTRODUCTION: Most of the patients with iliofemoral thrombosis treated with anticoagulants only are affected with postthrombotic syndrome (PTS) that worsens the patients' quality of life. In the acute phase of proximal deep venous thrombosis (DVT) catheter-directed (CDT) and pharmacomechanical thrombolysis may be a reasonable alternative therapeutic method. Our aim was to summarize our results using these methods. METHODS: Since 2009 twenty-four patients with iliofemoral DVT were treated with these endovascular procedures and with stenting at our Institution. RESULTS: The median age of the patients was 35.83 ± 15.9 years, the female: male ratio was approximately 2:1. The mean time between the onset of the symptoms and the procedures was eleven days. CDT alone was performed in 8 patients, thrombus aspiration in addition to CDT using AngioJet device in 16 patients; in 19 cases the procedure was completed with venous stenting. During the follow-up we performed US examinations and estimated the severity of PTS by Villalta-scale. The total recanalization-rate was more than 50%, which even improved during the follow-up. The total lysis time and the amount of used recombinant tissue plasminogen activator decreased significantly by applying the AngioJet. We did not find any severe PTS among our patients during the follow-up visits. CONCLUSION: Our data suggests that these methods can be used efficiently and safely in the treatment of acute iliofemoral DVT.

Should catheter-directed thrombolysis be monitored?

Catheter-directed thrombolysis for deep venous thrombosis is considered the basic treatment modality for intrathrombus removal. This method is preferably used in patients with iliofemoral deep venous thrombosis due to poor spontaneous recanalization in this segment, especially on the left side. The method was published almost 25 years ago and has gained ground in the treatment because of poor results from systemic thrombolysis and because of the possibility of stenting any underlying iliac obstruction during the procedure. However, the publications of catheter-directed thrombolysis reveal a great heterogeneity concerning catheter-directed thrombolysis technique and the lack of high quality evidence about monitoring as a tool to minimize the risk of bleeding and pulmonary embolism. Strict inclusion and exclusion criteria, correct composition and infusion of thrombolysis agent, imaging thrombus clearance during catheter-directed thrombolysis, ensuring flow enhancement during the bedridden situation, careful evaluation of indication for stenting based on imaging, and sufficient conversion to anticoagulation treatment following catheter-directed thrombolysis are essential. The aim of this paper is to discuss different treatment aspects of catheter-directed thrombolysis for iliofemoral thrombosis and to suggest a monitoring model for future treatment.