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Background:
The purpose of this study was to assess the safety and efficacy with midterm outcomes of pharmacomechanical thrombectomy (PMT) performed by using a relatively new thrombectomy device in the treatment of lower extremity deep vein thrombosis (DVT).
Methods:
Between February 2014 and February 2016, a total of 46 patients with lower extr...
Context in source publication
Context 1
... A number of percutaneous endovenous mechanical throm- bectomy are available. The Cleaner rotational thrombectomy device (Rex Medical, Fort Worth, Texas; Figure 1) functions by autorotating, helical shaping, and spinning a flexible guide wire within the vessel. This function allows the clots to be macerated and fragmented and aspirated through a sheath. ...
Citations
... Active removal of thrombi located in the deep veins during the acute phase of DVT has been confirmed by randomized controlled studies to be useful in preventing PTS [4]. In recent years, alternative and new methods like pharmacomechanical thrombectomy (PMT) with catheter-directed thrombolysis (CDT) have gained popularity as a result of their excellent results [5,6]. These procedures reduce post-thrombotic morbidity, maintain venous valve competency and also provide early clot elimination. ...
... Nevertheless, there is significant amount of research reporting the efficacy outcomes of combined PMT and CDT. In a multicenter, randomizedcontrolled CAVENT trial, CDT was performed on 189 patients with IFDVT, and it was demonstrated that CDT reduced PTS in cases at follow-up, with major complications developing in 3% in the study cohort [5]. Furthermore, in the ATTRACT study, which was conducted to determine PMT and CDT in preventing the development of PTS in 692 individuals with IFDVTs, it was shown that both the severity of PTS as well as leg pain and swelling were significantly improved in patients who underwent PMT and CDT [14,15]. ...
Aim: The purpose of this research was to investigate the early outcomes of pharmacomechanical thrombectomy (PMT) with the Mantis device and adjunctive catheter-directed thrombolysis (CDT) for the treatment of acute iliofemoral deep vein thrombosis (IFDVT). Material and Methods: Twenty patients with symptomatic acute IFDVT were successfully treated with the Mantis rotational thrombectomy device and CDT, between August 2020 and March 2021. Patients' demographical, clinical and follow-up data were obtained and analysed retrospectively. Villalta and Pain Severity scores were utilized to assess the patients for the occurrence of post-thrombotic syndrome (PTS). Results: The procedural success rate was 100%. All cases presented early clinical improvement. No device related complications were encountered. Reocclusion was observed in 3 (15%) patients. Pre-procedural median pain score was 7 (range: 6–8) and 1 (range: 0–7) at 12-month following thrombectomy (P < .001). Pre-procedural median Villalta score was 7 (range: 3–11) and 1 (range: 0–13) at 12-month following thrombectomy (P<.001). At 12-month follow-up, no PTS was reported in 15 (75%) patients, mild PTS was reported in 2 (10%) patients, moderate PTS was reported in 2 (10%) patients and no severe PTS was observed. Conclusion: The Mantis PMT system with CDT seems to be an efficient treatment approach for acute IFDVT with encouraging early results.
... Additionally, to promote continuous restoration of venous flow, balloon angioplasty and/or stenting were selectively used. The Cleaner Rotational Thrombectomy System was effective in the treatment of acute iliofemoral and femoropopliteal DVT [40][41][42]. Long-term outcomes using the Cleaner were reported in a study by Yuksel et al. (2017), which demonstrated a 67.5% PTS-free survival rate after a mean follow-up time of 16 months [42]. ...
... The Cleaner Rotational Thrombectomy System was effective in the treatment of acute iliofemoral and femoropopliteal DVT [40][41][42]. Long-term outcomes using the Cleaner were reported in a study by Yuksel et al. (2017), which demonstrated a 67.5% PTS-free survival rate after a mean follow-up time of 16 months [42]. ...
... The Cleaner Rotational Thrombectomy System was effective in the treatment of acute iliofemoral and femoropopliteal DVT [40][41][42]. Long-term outcomes using the Cleaner were reported in a study by Yuksel et al. (2017), which demonstrated a 67.5% PTS-free survival rate after a mean follow-up time of 16 months [42]. ...
Lower extremity deep vein thrombosis (DVT) leads to significant morbidity including pain, swelling, and difficulty walking in the affected limb. If left untreated, DVT increases the risk of pulmonary embolism (PE), recurrent venous thromboembolism (VTE), and post thrombotic syndrome (PTS). The objective of this review was to identify catheter-directed interventions and their success rates for the treatment of lower extremity DVT. A comprehensive search of current and emerging catheter-directed interventions for lower extremity DVT treatment was conducted in PubMed and Google Scholar. Clinical trials, retrospective and prospective observational studies, and case reports were identified to classify percutaneous mechanical thrombectomy (PMT), catheter-directed thrombolysis (CDT), and pharmacomechanical CDT (PCDT) devices based on their mechanism of action and indication of use. Catheter-directed interventions such as PMT, CDT, and PCDT offer an alternative therapeutic strategy for DVT management, particularly in patients with limb-threatening conditions and absolute contraindications to anticoagulants. Currently, there are limited guidelines for the use of mechanical and pharmacomechanical devices because of the lack of clinical evidence available for their use in treatment. Future studies are required to determine the short and long-term effects of using catheter-directed interventions as well as their effectiveness in treating acute versus subacute and chronic DVT.
... 11 The most well-known factors in the etiology of lower-extremity deep vein thrombosis are genetic predisposition, malignancy, history of surgical operation, immobilization, trauma, bone fractures, long journeys and oral contraceptive use. 12 Nevertheless, there may also be other factors that play a role in the etiopathogenesis of deep vein thrombosis. ...
Background:
Vitamin D has relationships with pathogenesis and inflammation pathways in many diseases. Its deficiency may make clinicians think not only of supplementation but also of presence of other diseases.
Objective:
To investigate the relationship between vitamin D levels and deep vein thrombosis (DVT), given that reduced levels are related to increased risk of cardiovascular diseases.
Design and setting:
Case-control study conducted in the cardiovascular surgery and family medicine departments of a hospital in Turkey.
Methods:
A total of 280 participants were included: 140 each in the DVT and control groups. Basic clinical characteristics, comorbidities and serum 25-hydroxyvitamin D (25(OH)D) levels were recorded and then compared between the groups. Serum 25(OH)D levels were also evaluated separately in three subgroups (sufficient, insufficient and deficient).
Results:
Serum 25(OH)D levels were significantly lower in the DVT group than in the controls (P < 0.001). Females in the DVT group had lower 25(OH)D levels than those in the control group (P = 0.002). Nonetheless, the median 25(OH)D level (16.41 ng/ml) of the control group was still below the reference value. Logistic regression analysis showed that 25(OH)D was a significant predictor of DVT. Weight, height and body mass index, which all presented interaction, were significant in the logistic regression analysis but not in individual analyses.
Conclusion:
The serum vitamin D levels of DVT patients were lower than those of controls. If the results obtained from our study are supported by further large-scale randomized controlled trials, vitamin D replacement may be brought into the agenda for protection against DVT.
... While commonly used, a paucity of data currently exists on this device for arteriovenous access maintenance, with only a handful of published studies which are limited to its use in deep vein thrombosis. [10][11][12] This study therefore aimed to assess the safety and efficacy of arteriovenous dialysis shunt thrombectomy utilizing the Cleaner ® rotational thrombectomy device in patients with pseudoaneurysms and clotted accesses refractory to conventional thrombectomy methods. ...
Aims: To assess the safety and efficacy of dialysis shunt thrombectomy utilizing a rotational thrombectomy device in patients with pseudoaneurysms refractory to declot by conventional treatments. Methods: Between July 2016 and August 2019, 34 dialysis shunt thrombectomies were retrospectively examined in 29 individual patients. All patients presented with pseudoaneurysms and clotted accesses that were refractory to angioplasty balloon sweeps (“push–pull”) to restore patency. The Cleaner® rotational thrombectomy device was used as a bail-out in an attempt to restore patency to the clotted shunt. Procedure success, complications, primary patency, primary-assisted patency, secondary patency, average number of shunt pseudoaneurysms, and average pseudoaneurysm size were documented and analyzed. Results: Thirty-three of the 34 (97%) thrombectomies were successful in restoring patency and facilitating same-day hemodialysis. An average of 1.5 pseudoaneurysms were present per patient (range 1–3 pseudoaneurysms, standard deviation [SD] 0.65 pseudoaneurysms), with an average size of 15.0 mm (range 9.4–31.1 mm, SD 4.87 mm). Postprocedural complications occurred in 14.7% of the cases, none of which were definitively device related. Primary patency to the time of data collection was achieved in 29% of the cases, and the average primary patency for these cases was 124.5 days (range 10–946 days, SD 186.9 days). The average primary-assisted patency was 126.8 days (range 1–564 days, SD 169.8 days). Dialysis accesses were eventually abandoned or surgically revised in ten instances, resulting in an average secondary patency of 157.5 days (range 6–712 days, SD 257 days). Conclusions: In patients with pseudoaneurysms, rotational thrombectomy with the Cleaner® device appeared to be a safe and effective option for restoring patency to thrombosed dialysis accesses refractory to standard push–pull techniques with angioplasty balloons.
... Although medical and surgical treatment modalities have evolved in recent years, DVT still poses a potential problem, as it is associated with various clinical entities such as chronic venous insufficiency, phlegmasia cerulea dolens, venous gangrene, and pulmonary thromboembolism which all can have severe consequences. [2][3][4][5] Hereditary or acquired tendency to thrombosis, hypercoagulability, venous stasis, endothelial damage, and inflammation are the main factors which play a role in the etiopathogenesis of DVT. ...
Background:
The aim of this study was to investigate whether routine complete blood count parameters such as the mean platelet volume, red cell distribution width, white blood cell and platelet counts, and novel inflammatory biomarkers such as platelet-to-lymphocyte ratio and neutrophil-to-lymphocyte ratio could be used as the predictors of acute deep vein thrombosis.
Methods:
This retrospective study included a total of 68 patients (29 males, 39 females; mean age 55.2±1.6 years; range, 22 to 80 years) with acute lower extremity deep vein thrombosis and 34 healthy controls (15 males, 19 females; mean age 52.8±2.5 years; range, 21 to 77 years) without acute lower extremity deep vein thrombosis between March 2016 and August 2018. Demographic and clinical characteristics of the participant and laboratory data including complete blood count parameters were recorded. Univariate and multivariate analyses were used to identify significant predictors of deep vein thrombosis.
Results:
Demographic and clinical characteristics were similar between the groups. According to the univariate analysis, platelet count and red cell distribution width were found to be significantly higher in the patient group compared to the control group. However, the red cell distribution width was not considered a significant predictor of acute deep vein thrombosis. According to the multivariate logistic regression analysis, the platelet-to-lymphocyte ratio and platelet count were significant predictors of acute deep vein thrombosis.
Conclusion:
Our study results show that the platelet-tolymphocyte ratio may be a useful biomarker to support the diagnosis of acute deep vein thrombosis.
... V enous thromboembolism (VTE) refers to the development of thrombi into the veins and an occlusion in the pulmonary artery and branches caused by embolic fragments from these thrombi. [1][2][3] Since in general deep vein thrombosis (DVT) occurring with the formation of thrombi in deep veins of lower extremity and its complication pulmonary embolism (PE) are associated, venous thromboembolism (VTE) term is often used for DVT and/or PE. VTE is an Objectives: To evaluate patients diagnosed with venous thromboembolism (VTE) in terms of hereditary thrombophilic risk factors and to assess genetic and biochemical factors affecting the development of VTE. ...
... Iliofemoral deep venous thrombosis (IFDVT) is strongly related to severe postthrombotic morbidity, embodied by a reduction in the quality of life. 1 It can impact the daily routine and lead to consequential complications, such as varicosity, limitation in activity, postthrombotic syndrome (PTS), and even pulmonary embolism (PE). 2 Treatment options for IFDVT have developed with the increasing utilization of catheter-directed thrombolysis (CDT) and pharmacomechanical thrombolysis (PMT). 3,4 Catheter-directed thrombolysis is a therapy that the guidewire passed through the thrombus lesion under the assistance of a supporting catheter, followed by a multiple-sidehole infusion catheter. The catheter was placed within the thrombosed vessel and secured in place. ...
Early catheter-directed thrombolysis (CDT) for deep vein thrombosis (DVT) can reduce postthrombotic morbidity. Pharmacomechanical thrombolysis (PMT) is a new therapy that can be selected for the treatment of iliofemoral deep vein thrombosis (IFDVT). We performed a meta-analysis of clinical trials comparing PMT versus CDT for treatment of acute IFDVT. Literature on this topic published between January 1, 1990, and June 1, 2018, was identified using PubMed, Embase, Cochrane Library, and Web of Science. Six trials were included in the meta-analysis. Compared to CDT, PMT significantly reduced the Villalta score (P = .007; I² = 0%), thrombus score (P = .01; I² = 0%), the duration in the hospital (P = .03; I² = 64%), and thrombolysis time (P < .00001, I² = 0%). There was no significant difference in valvular incompetence events (P = .21; I² = 0%), minor bleeding events (P = .59; I² = 0%), stent events (P = .09; I² = 24%), and clot reduction grade I events (P = .16; I² = 43%) between PMT and CDT. Subgroup analysis was performed by dividing the clot reduction grade I events group into PMT plus CDT versus CDT group and significant differences were found (P = .03, I² = 0%) as well as for PMT alone versus CDT group (P = .88, I² = 37%). This meta-analysis shows that PMT reduces the severity of postthrombotic syndrome (PTS), thrombus score, duration in hospital, and thrombolysis time compared to CDT. More specifically, PMT plus CDT reduces clot reduction grade I events. No significant difference in valvular incompetence events, stent events, and minor bleeding events were found when PMT was compared to CDT.
Background
We report our single-center immediate and follow-up results in the management of acute iliofemoral deep vein thrombosis (IFDVT) with pharmacomechanical catheter-directed thrombolysis (PMCDT), to determine the safety, accuracy, and affect the quality of life (QOL) and to determine whether this treatment strategy prevents post-thrombotic syndrome (PTS).
Method
A total of 230 patients who underwent PMCDT due to IFDVT between January 2017 and December 2018 were retrospectively reviewed. Preoperative, operative, and postoperative variables, Marder scores, outcome, and follow-up assessments with Villalta (VS) and venous clinical severity scores (VCSS) were investigated.
Results
Anatomical success was achieved in 95.2% of patients. Mean Marder score decreased from 12.65 + 2.1 to 2.4 + 1.3 postoperatively (p<0.01). Early re-thrombosis occurred in 13 patients (5.65%). Primary patency at the 1-, 6-, and 12-month follow-up visits was 94.0%. and 87.2%, and 81.7%, respectively. From the 1st month to the 6th month, VS decreased from 8.32 + 4.14 to 3.43 + 0.61 and Venous Clinical Severity Score decreased from 4.0 + 1.8 to 1.82 + 0.36 (p<0.05). No statistically significant difference was found in PTS severity scores at the 12th-month follow-up compared to the 6th month. Mean change at venous disease-specific QOL from baseline to 12 months was 29.41 + 1.99 (p=0.029). Total recurrence was 19.63% at one year.
Conclusion
In a selected group of patients with acute IFDVT, PMCDT and postoperative anticoagulation offered significant reductions in clot burden, leg pain, and swelling, achieving a significant reduction in PTS severity scores at sixth months.
