The efficacy of rotational pharmaco-mechanical thrombectomy in patients with acute iliofemoral deep vein thrombosis: Is the standard treatment of deep vein thrombosis changing?

Abstract

Objective

In this study, we aimed to evaluate the efficiency of rotational thrombectomy device in pharmaco-mechanical thrombolysis for symptomatic acute ilio-femoral deep vein thrombosis.

Materials and methods

Between August 2013 and May 2018,82 patients with acute deep vein thrombosis comprising the iliofemoral segment whom underwent Pharmaco-mechanical thrombolysis were evaluated retrospectively. The Cleaner thrombectomy device was used. The resolution of thrombi was examined and graded. Development of post-thrombotic syndrome was assessed with Villalta scores.

Results

75 patients (91.4%) had complete thrombus resolution. Between 50–99% resolution was noted in 6 patients (7.4%) and in one (1.2%) case less than %50 thrombus resolution was obtained. Seventy-five patients (91%) of the cohort could be treated in a single session; 7 patients (8.6%) required reintervention(s). Although improved post-thrombotic syndrome rates were lower at the short term, Villalta scores gradually increased during follow up.

Conclusions

In conclusion, Pharmaco-mechanical thrombolysis with Cleaner thrombectomy device is a safe and beneficial method for the treatment of acute iliofemoral deep vein thrombosis. Long term follow up data of large volume multicenter studies are warranted.

Keywords

Deep vein thrombosis pharmaco-mechanical thrombolysis post-thrombotic syndrome

Introduction

Deep vein thrombosis (DVT) is a serious health problem and one of the main reasons of morbidity and mortality throughout the world.¹Pathology may be lethal by pulmonary embolism or associated with lifelong debilitating symptoms due to post-thrombotic syndrome (PTS); hence, it requires immediate action with available pharmacologic, mechanical or combinational treatment options.² Post-thrombotic syndrome has characteristic components such as extremity pain, swelling, chronic deep venous insufficiency, venous claudication, skin changes including thickening and discoloration and even ulcer formation which end up with a chronic unresolvable situation with multiple hospital admissions and psychosocial impairment as well as increasing healthcare expenses.^3,4 The syndrome is partially attributed to venous obstruction otherwise clot organization at the valve levels with resultant impairment of the valvular functions.^5,6 The incidence of PTS ranges from 35% to 70% in patients especially experiencing proximal deep vein thrombosis (DVT).^7,8

Conventional treatment of deep vein thrombosis includes recanalization attempts with thrombolytics and anticoagulants. Pharmaco-mechanical thrombolysis (PMT) combining catheter induced thrombus derangement with thrombolytic agents is considered as an effective method for the treatment of DVT with increasing clinical experience. Several PMT devices have been instituted^9,10 in the past two decades and ‘Cleaner thrombectomy device’ (Argon Medical Devices, Plano, TX, US) which is a battery-operated thrombectomy catheter¹¹ is among them. The wire of this device is helical-shaped, flexible, and has autorotating function inside the vessel. Distal atraumatic catheter tip with sinusoidal wire design enables gentle mechanical thrombectomy with fluid vortex, macerating the thrombus¹² which facilitates the efficiency of the thrombolytic agent.

In this study, we aimed to evaluate the use and efficiency of Cleaner rotational thrombectomy device for pharmaco-mechanical thrombolysis in patients with symptomatic acute iliofemoral DVT.

Patients and methods

In this study, 82 patients with the symptoms of acute iliofemoral DVT lasting less than 14 days between August 2013 and May 2018, who were treated with Cleaner Rotational Pharmaco-Mechanical Thrombectomy Device (Argon Medical Devices, Plano, TX, US) were studied retrospectively. All the patients presenting to the clinic with the symptoms of DVT were diagnosed with venous duplex ultrasonography (USG).During the interventional therapy, the extent of the thrombosis was examined. The patients who had acute symptomatic iliofemoral DVT involving the iliofemoral or iliocaval segments for the first time in their lives were included to the study. Exclusion criteria were the patients younger than 16 years of age and older than 85 years of age, the patients with upper extremity thrombosis, severe renal failure, terminally ill patients or the patients who had contraindications to thrombolytic therapy.

Working principle of cleaner rotational pharmaco-mechanical thrombectomy device

All the procedures were carried out with Cleaner Rotational Pharmaco-Mechanical Thrombectomy Device (Argon Medical Devices, Plano, TX, US).The working principle of the device relies on an “S” shaped guide wire. The wire functions by spinning within the vessel.¹¹ The device rotates at approximately 4,000 rpm, and the clot is macerated and aspirated through the sheath.¹² The system enables safe maceration of the clot by liquid vortex without the endothelial damage. The guide-wire provides good directionality. The three-way side port on the distal part of the catheter provides thrombolytic agent and contrast infusion.¹³

Follow up evaluation of the patients

After 3, 6 and 12 months of the intervention, the PTS was examined with the Villalta scale.¹⁴The scale contains five symptoms that are pain, cramps, heaviness, pruritus, and paresthesia. In addition the assessment has six objective signs such as edema, skin induration, hyperpigmentation, venous ectasia, redness, and pain during calf compression.¹¹The rates are 0 (absent), 1 (mild), 2 (moderate), and 3 (severe).The total score was calculated in all patients and scores less than 5 indicated the absence of PTS, scores of 5–9 indicated mild PTS, scores of 10–14 indicated moderate PTS, and scores greater than 15 or ulceration indicated severe PTS.^11,15,16

Pharmaco-mechanical thrombectomy technique

In all patients, a retrievable inferior vena cava filter (Option retrievable vena cava filter; Argon Medical Devices, Plano, TX, US) was placed using contralateral femoral or internal jugular vein access before the procedure. All of the applications were made with local anesthesia. A 6-F sheath was inserted percutaneously into the popliteal or posterior tibial vein with local anesthesia with ultrasonography guidance.100 units/kg unfractionated heparin was administered intravenously. The activated partial thromboplastin time was increased two- to three folds and activated clotting time was increased above 180-220 seconds. A 6-F Cleaner thrombectomy device was inserted through the introducer sheath. A recombinant form of tissue plasminogen activator (tPA),(alteplase; Actilyse; Boehringer Ingelheim, Ingelheim am Rhein, Germany) was administered through the port side of the device. The device was operated to use the S-shaped wire (Figure 1; Supplement 1).Thrombolysis was performed for 2–5-minutes, then the device was stopped and temporarily withdrawn. The macerated thrombus and residual lytic components were aspirated through the sheath. Subsequently, venogram was performed to control the treated area and the device was inserted to apply repeated thrombolysis to the more cranial segments. The amount of the administered dose of tPA was set depending on the patient’s weight and the thrombus load, a total of up to 0.9 mg/kg. After device removal, a last control venogram was performed. If the thrombus removal was less than 50% of the thrombosed segment, reintervention was performed.

Figure 1.

Appearance of the device in the iliac vein.

Most retrospective studies demonstrated that PMT is associated with shorter treatment time, lower thrombolytics dose, and shorter hospital stay compared to catheter directed thrombolysis treatment.^17–19 Therefore, only Pharmaco-mechanical thrombectomy treatment was performed in patients with acute DVT who meet the inclusion criteria for thrombolysis during study period. Cleaner Rotational Pharmaco-Mechanical Thrombectomy Device (Argon Medical Devices, Plano, TX, US) was preferred due to satisfying procedural results, clinical experience of the physicians with the catheter and availability of the catheter at the institution during the study period.

Catheter directed thrombolysis was reserved only for cases with residual thrombosis after PMT application as a complementary procedure. In those cases, if the control venogram revealed residual thrombosis, the procedure was either terminated or a 4-F infusion catheter (Cragg-McNamara Micro Therapeutics, CA, USA) was inserted, and 1 mg/h tPA was administered for 24 hours.²⁰ After the first ten cases, lytic reinfusion was administered routinely for cases with residual thrombus, rather than the termination of the procedure. If there was a severe stenosis or non-responding iliocaval obstruction, percutaneous transluminal angioplasty was performed. Repeated thrombectomy and balloon angioplasty were not hesitated as reinterventions in the acute phase (Supplement 2), whereas stenting was mainly reserved for non-responsive or partially responsive cases usually with chronic DVTs during the follow-up.

After the interventional therapy, subcutaneous low molecular weight heparin was given to all patients, then the therapy was converted to oral warfarin. The aim of the warfarin therapy was to keep International Normalized Ratio at a range between 2–3. The inferior vena cava filters were removed within 1 week. All the patients were strongly advised to wear compression stockings at least for 3 months and to be continued depending on the symptoms and PTS.

During follow up, thrombolysis, bleeding, pulmonary emboli and DVT were examined. Control venography was performed by the same interventionalist, and the venograms were compared with the venograms before the procedure; also graded depending on the thrombus extraction. Grade III was defined the complete thrombolysis.²⁰ While Grade I lysis was defined as an extent of thrombus resolution less than 50%, Grade II was defined as 50%–99% resolution.²⁰ Following completion venogram, inferior vena cava filter was evaluated with inferior vena cava venogram to examine if there was thrombus trapped in the filter. Again, before discharge of the patient, a clinical assessment and Doppler ultrasonography was performed.

Statistical analysis

The statistical analysis were performed with SPSS 18.0 software (Statistical Package for Social Sciences Inc., Chicago, IL, US).Data are expressed as mean ± SD for continuous variables and as counts for categorical variables. Comparisons of clinical, angiographic and procedural characteristics were performed with the Fisher exact test for categorical variables and Mann-Whitney U test for continuous variables. Thrombolysis rate and PTS were compared with χ² test. The correlation analysis between the onset of first symptoms and Villalta Scores to evaluate the PTS was performed with Pearson Rank correlation analysis. A p value <0.05 was described statistically significant.

Results

Among 82 cases included into the study, there were 50 male and 32 female patients. Mean age was 45.7 ± 18.9 years (range: 22–78 years). The symptoms of the patients were lower extremity swelling, extremity pain, or phlegmasia cerulea dolens. Phlegmasia cerulea dolens was noted in eleven patients (13.4%). All patients had an iliofemoral venous thrombosis. The patients were within acute state of DVT and mean duration of symptoms was 7.2 ± 5.6 days (range: 1–14 days). Forty-eight (58.5%) patients had thrombosis on the left side. The patients underwent intervention within 12–48 hours of hospital admission. In all patients, a retrievable IVC filter was used. Popliteal vein was the main access site for PMT in all other patients. The mean amount of tPA infused was 22.5 ± 12.7 mg (range:10–50 mg), and the mean procedure time was 55.8 ± 20.4 minutes, (range: 35–125 min).Throughout the course of the study, the doses of tPA administered per case were increased and the procedure time was decreased in correlation with the clinical experience. Moreover, catheter directed thrombolysis was administered routinely for cases with residual thrombus as a complementary therapy, rather than the termination of the procedure. When a severe stenosis is detected or in non-responding iliocaval obstructions, percutaneous transluminal angioplasty was performed. Seventy-five of the 82 patients (91.4%) did not require any other interventions and could be treated successfully in single session. All the partially responsive 7 cases (8.6%) received balloon angioplasty and complementary catheter directed thrombolytic infusion was administered to these patients for 24 hours due to residual thrombus. Failure of the device or side effects secondary to the device were not observed in any patients during the procedures.

There was more than 50% lysis of thrombus in 81 patients (98.7%) with single session of PMT detected with control venograms at the end of the procedure. In 75 patients (91.6%) Grade III lysis (complete resolution) was achieved. Grade II lysis was observed in 6 patients (7.3%). Only 1 case (1.2%) had been non-responsive to balloon angioplasty and catheter directed thrombolysis (Grade I); however, the decision was to follow the patient with conventional anticoagulation and stenting was reserved for the chronic state if the symptoms of the patient persisted. The symptom duration and degree of lysis had an inverse relationship and symptoms of the patients immediately disappeared upon recanalization (Table 1).

Table 1.

The relationship between the duration of symptoms and resolution grade.

Resolution grade	Patients (n)	Symptoms duration
Grade I resolution	1	10–14 days
Grade II resolution	6	7–10 days
Grade III resolution	75	1–7 days

According to the table there is an inverse relationship between the duration of symptoms and the degree of lysis.

Including the additional interventions, Grade III, II, and I thrombus resolution rates were increased to 93.9% (n = 77), 4.9% (n = 4), and, 1.2% (n = 1), respectively. Prominent clinical improvement was observed in 81 patients (98.7%) before discharge. The Doppler ultrasonographies that were performed before discharge revealed patent veins in 81 patients (98.7%). The mean follow-up was 7.8 ± 4.3 months (range, 6–18 months). Recanalized veins were detected in 81 patients (98.7%) with clinical assessment and Doppler ultrasonographies in the first 6 months controls. The remaining patient was re-admitted to the clinic on the 5th month with acute onset deep vein thrombosis, severe pain and phlegmasia cerulea dolens. He was a heavy smoker, incompatible with the anticoagulant regime and had a history of long train travel. He was re-intervened and iliac vein stenting (16 mm) was performed at the session.

Villalta scoring was applied to detect the severity of PTS in the patients. The average Villalta score was 2.68 ± 1.4 (range: 1–5) at 3 months. No statistically significant correlation between Villalta scores and onset of the treatment after the initiation of the symptoms was detected in patients in the first 3 months follow up (p > 0.05) (Table 2). According to Villalta scores, in 75 patients (91.5%) PTS did not occur, and 7 patients (8.5%) had mild PTS at the end of the 3rd-month follow up. The mean Villalta scores as well as the number of patients with PTS increased over time. From the 82 initially treated patients, at the end of 6 months, 15 patients were lost to follow up due to various reasons. Mean Villalta scores of the remaining 67 patients were calculated as 3.82 ± 2.41 (range: 2–11).Accordingly, there were 48 patients (71.6%) with no PTS,11 patients (16.4%) with mild PTS and 8 patients (11.9%) with moderate PTS. The increase in Villalta score; hence, the increasing incidence and severity of PTS was not significantly correlated with early hospital admission and onset of treatment after the initiation of first symptoms (p > 0.05) (Table 2). The longest follow up duration in our cohort could be up to 18 months; however, we were able to calculate the Villalta scores of 54 patients at the end of 12 months. The mean Villalta scores was 4.2 ± 3.68 (range: 2–15). Again, we did not detect a significant correlation between initial hospital admission-recanalization and development of PTS in our cohort (p > 0.05) (Table 2). Results indicated that the PTS over time was not associated with early hospital admission or recanalization attempts.

Table 2.

The relationship between Post-thrombotic Syndrome (PTS) based on the Villalta scores and the duration of symptoms during the first 3,6 and 12 months after the interventions.

Villalta Scale Score	Post-thrombotic Syndrome	Patients (n)	Symptoms duration
3 Months
<5	None	75 (91%)	3–14 days
5–9	Mild	7 (9%)	1–12 days
10–14	Moderate	–
>15	Severe	–
6 Months
<5	None	48 (72%)	2–14 days
5–9	Mild	11 (16%)	1–13 days
10–14	Moderate	8 (12%)	3–12 days
>15	Severe	–
12 Months
<5	None	36 (67%)	1–14 days
5–9	Mild	9 (17%)	1–9 days
10–14	Moderate	7 (13%)	3–12 days
>15	Severe	2 (3%)	3–10 days

Complications

Periprocedural mortality and pulmonary embolism did not occur in any of the patients. Major bleeding did not occur; however, in thirteen patients (15.8%) minor bleeding at the access site was observed. In 21 patients (25.6%) patients minor hematoma or various degrees of ecchymosis was detected. None of the complications were debilitating and affected the routine daily lives of the patients.

Discussion

Deep venous thrombosis is a serious health condition, which carries the risk of pulmonary embolism. The treatment of the pathology was considered with an aim to prevent symptomatic pulmonary embolism, early thrombus progression, and recurrent venous thromboembolism.^21,22 Conventional treatment is performed medically with thrombolytics and anticoagulants.²³ Together with advances in technologic therapeutic interventional tools, with an aim to achieve rapid thrombolysis and recanalization percutaneous endovascular techniques alone or in combination with thrombus aspiration and thrombolytic agent infusion systems are frequently applied worldwide for the treatment of DVT in the current era.²³ In our patient group, we preferred Cleaner Rotational Pharmaco-Mechanical Thrombectomy Device (Argon Medical Devices, Plano, TX, US) and achieved more than 50% thrombolysis in 98.8% of patients. Similar success rates within a single session were reported in the literature previously.²⁴ The optimal result of this therapy is to achieve Grade III lysis.We have detected Grade III lysis in 91.4% of patients. Seven patients who had Grade II lysis after first intervention underwent additional session and in one patient complete lysis could not be provided.

The success of thrombolysis increases when DVT symptoms are present shorter than 10–14 days. This supports that thrombolysis has better results in the presence of recently formed thrombi.²⁵ Various studies indicated that in the patients with symptoms longer than 10 days, complete thrombolysis rates had been lower.²⁶ Our results were consistent with the literature as when applied in acute cases, Pharmaco-mechanical thrombectomy had been associated with increased recanalization rates.

In a study by Lopez et al, the Indigo continuous aspiration mechanical thrombectomy 8 system (Penumbra, Inc, Alameda, C, USA) was used in the patients with acute iliofemoral or central DVT. The success of the technique was defined as resolution of more than 70% of thrombus without catheter directed thrombolysis at any stage. The technical success was %60 in one setting. Recurrence following successful procedure was detected in 2 patients.²⁷ In another study by Hong Shian et al,⁷ F Amplatz thrombectomy device was used for mechanical thrombectomy in the patients with acute massive lower extremity deep venous thrombosis. In 92% of the patients, grade III lysis was observed and in 2 patients among 25 cases, grade II lysis was achieved.²⁸ In the study by Bozkurt et al, the Cleaner thrombectomy device was used in patients with extensive iliofemoral and/or femoropopliteal acute DVT. The procedure was successful in 14 patients among 16 patients.¹² Our results were similar to the studies with successful results in the patients who underwent mechanical thrombectomy.

Post-thrombotic syndrome is one of the most important complications secondary to DVT. It is caused by venous obstruction and valvular reflux following DVT.^11,29 In a study by Enden et al. the risk of PTS was lower in the patients who underwent catheter directed thrombolysis over a 2-year follow-up period.³⁰ In contrary to these results, CAVA trial showed that there was no significant reduction of PTS following ultrasound-accelerated catheter-directed thrombolysis in patients with acute iliofemoral DVT.³¹ The risk of PTS was not significantly different when compared with standard therapy after 1 year of acute iliofemoral DVT.³² The ATTRACT trial, compared Pharmaco-mechanical thrombolysis plus standard therapy and standard anticoagulant therapy alone in patients with acute DVT at the femoropopliteal segments and proximal iliac segments.³³ The risk of PTS did not differ between groups. However, in patients with proximal iliac DVT, the patients who underwent PMT had decreased number of moderate to severe PTS(34) The main limitation of the study was lack of subgroup analysis.³⁴ Similar results were obtained in our cohort evaluated with Villata scores. Both trials were unable to demonstrate the effectivity of Pharmaco-mechanical thrombectomy against the overall development of PTS in the duration of one year and two years, respectively.^32,33 On the other hand, our results were suggestive for the reduced severity of PTS for future follow-up, as the percentage of PTS free patients were quite high and there were no patients with severe PTS within the first 6 months and only two severe PTS cases within the first 12 months.

Residual iliac vein compression is attributed as an important risk factor for PTS and DVT. Restoration of smooth venous return contributes significantly to better outcomes against DVT, PTS and improved Villalta scores which may be achieved with angioplasty or stenting.³⁵ Routine stenting following PMT was applied by Engelberger et al. with promising high patency and low PTS rates.³⁶ Despite our promising early results, the Villalta scores seemed to worsen with time in our cohort. This could be associated with very low stenting rate in our study.

Bleeding is another important complication of thrombolysis.³⁷ Incidence of major bleeding is approximately 2–4% in patients receiving catheter directed thrombolysis.³ We noted minor bleeding at the access sites, which occurred in thirteen patients (15.8%). In some studies, when Pharmaco-mechanical thrombectomy was compared with conventional catheter directed thrombolysis, doses of thrombolytic agents and bleeding complications were found lower with Pharmaco-mechanical thrombectomy.^24,38

There is not an accepted consensus about the use of IVC filters before thrombolytic therapy. Retrievable IVC filters are efficacious in preventing pulmonary embolism and in trapping embolus. In our patients, we did not observe IVC filter associated complications, such as insertion site thrombosis, filter migration, symptomatic pulmonary embolisms, or vena cava injury. Filters are routinely used in our cases as an extra precaution against pulmonary embolism.

Conclusion

The Pharmaco-mechanical thrombectomy with Cleaner thrombectomy device is a safe and beneficial procedure with good results in the treatment of acute iliofemoral deep vein thrombosis. Although together with increasing experience the early results have been promising with regards to lower rates of post-thrombotic syndrome and prompt interference with the occlusion, follow up results are still associated with similar post-thrombotic syndrome issues in accordance with the literature.

Limitations

The retrospective nature of this study is one of the major limitations. The small number of patients and the relatively short follow up period are the other limitations of the study. The researched patients were the longest followed cases and even up to 1/3 of the patients refused hospital controls due to various reasons. The use of only the Cleaner Pharmaco-mechanical Thrombectomy system and not the other available devices in the market as well as their comparative results may be other limiting factor. The Cleaner system was available at the institution during the period and the primary physician has sufficient experience it; thus, it was the primary choice for the treatment of the patients. As a last limitation, we did not compare the results of interventional deep vein thrombosis with conventionally medically managed cases; however, our results had been consistent with well-known other studies in the literature. A separate study was also designed to provide our institutional findings on the issue with increased number of patients longer duration of follow up as well.

Footnotes

Acknowledgements

Declaration of Conflicting Interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

Ethical approval

It is a retrospective study, and the patients’ consents had been taken.

Guarantor

OR.

Contributorship

OR, CEY, DMO, MOB, MOU, OU, and MU acted in study design. OR and CEY are the responsible authors for data collection and analysis. Manuscript was primarily written by OR and CEY. DMO, MOB, MOU, OU, and MU helped in writing and linguistic revision of the paper.

Acknowledgements

None.

ORCID iD

Didem Melis Oztas

Supplemental material

Supplemental material for this article is available online

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