ABSTRACT
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.
Introduction
Deep venous thrombosis (DVT) is a highly prevalent disease, with an annual incidence of 1.6 per 1000 worldwide (Citation1). Although anticoagulation therapy has been the mainstay of DVT treatment, 20–50% of DVT patients who receive anticoagulation alone can still develop post-thrombotic syndrome (PTS) (Citation2), which results in significant lower quality of life and a higher economic burden (Citation3). Iliofemoral deep venous thrombosis (IFDVT), as a specific subgroup with the highest rate of PTS, accounts for 80% of symptomatic DVT (Citation4,Citation5). Studies have shown that patients with extensive IFDVT receiving conventional anticoagulant therapy are more than twice as likely to develop recurrent DVT as patients without IFDVT (Citation6). Therefore, more effective treatment modalities have been investigated to reduce the recurrence of DVT and the occurrence of PTS.
Current international guidelines suggest that early thrombus removal should be performed in patients with acute IFDVT (Citation7–10). Various catheter-based endovascular techniques have been attempted in minimally invasive thrombus removals, such as standard catheter-directed thrombolysis (CDT), ultrasound-assisted CDT, pharmacomechanical CDT (PCDT), and percutaneous mechanical thrombectomy (PMT) without thrombolysis (Citation11,Citation12). It has been suggested that the risk of PTS is associated with the amount of thrombus remaining after CDT (Citation13–16). The ATTRACT trial did not provide evidence that PCDT reduced the incidence of PTS but did reduce the severity due to its ability to decrease the thrombus burden immediately after PCDT (Citation17,Citation18). This indicates that complete clot lysis and restoration of ideal antegrade in-line flow during the first thrombolysis treatment immediately after initial thrombus removal procedure may be crucial for improving long-term outcomes of IFDVT management.
Early thrombus removal with PMT is commonly combined with postoperative thrombolysis (POT) (Citation19). The treatment methods of DVT have become increasingly diverse, but attention to POT remains deficient. CDT, one of the most commonly used POT methods (Citation20,Citation21), has several shortcomings associated with long-term in-dwelling, including the need for sheath placement, lack of comfort, and various catheter-related complications (Citation22). Therefore, we propose a novel POT method that enables continuous infusion of thrombolytic drugs through a central venous catheter (CVC) with a portable syringe pump. We found that the thin, short, and flexible CVC exhibits great potential for safe, comfortable, and effective thrombolysis. Moreover, patients were able to receive early rehabilitation training during thrombolysis, which could promote DVT recovery. The purpose of this single-center study was to evaluate the safety and efficacy of this novel thrombolytic method after PMT in patients with overall acute IFDVT.
Materials and methods
Patient profiles
This study retrospectively selected all patients with acute IFDVT who underwent PMT and subsequently received POT treatment through CVC with a portable syringe pump in our vascular surgery department between January 2020 and August 2021. The diagnostic standard for IFDVT in this study was detailed as iliac and/or common femoral vein thrombus, with/without inferior vena cava thrombus for less than 14 days (Citation23). All patients underwent ultrasonography to diagnose IFDVT and received computed tomographic pulmonary angiography (CTPA) as well as computed tomography venography (CTV) to assess the presence of pulmonary embolism (PE) and iliac vein compression, respectively. The extent of thrombosis in the imaging studies was further graded as follows:
Grade I: Thrombosis involving the external or common iliac vein only.
Grade II: Thrombosis involving both iliac and femoral veins.
Grade III: Thrombosis extending from the iliac to the popliteal vein (Citation24).
The study was approved by the institutional ethical committee, and individual consent for this retrospective analysis was waived.
Procedural technique
All procedures were done in the supine position and performed under conscious sedation with local anesthesia. The choice of anesthetic agent was determined by the surgeons. According to Chinese national guidelines (Citation25), a retrievable inferior vena cava filter (IVCF) was routinely placed below the bilateral renal veins and above the opening of the iliac vein through a femoral venipuncture angiogram after ascertaining the patency of the inferior vena cava in the beginning of the procedure to prevent PE development. Angiography was done to rule out any deviation in the position of the filter. Afterward, the long sheath was left in place for subsequent use.
All venous access was established in the vessels below the knee (BTK), including in the proximal posterior tibial vein (PPTV), anterior tibial vein (ATV), distal posterior tibial vein (DPTV), and peroneal vein (PeV), to sufficiently facilitate thrombi removal during the procedures and maintain patient comfort and ambulatory care after the procedures (). Venous access was obtained through four approaches: ultrasound-guided puncture, crossover guidewire- or roadmap-guided puncture, great saphenous vein roadmap-guided puncture, or fluoroscopic image of tibial bone-guided puncture. Twenty-one gauge microneedles with associated microwires and introducers (COOK, USA) were used in all punctures. A 10 French vascular sheath (Cordis, USA) was introduced to accommodate the aspiration catheter, and stents with different sizes were placed to manage iliac vein compression.
Figure 1. Surgical procedures and follow-up of patients with IFDVT. (a) the distal posterior tibial vein (DPTV) was punctured using a 21 G puncture needle, visualized by pushing contrast through the saphenous vein to the filling defect in the lumen at the point of thrombosis. (b&c) a 5 F vascular sheath was placed and then replaced by a 10 F vascular sheath. (d&e) the angiography showed extensive thrombosis in the iliac, femoral, and popliteal veins with blood flow obstruction. (f&g) After MAT, iliac vein PTA and stenting restored linear blood flow from the popliteal vein to the inferior vena cava, but residual thrombus was seen in the distal superficial femoral vein. A one-lumen 5 F CVC was placed for POT. (h&i) After 3 days of POT therapy, the repeated angiography showed an ideal restoration of blood flow without thrombosis in the iliac, femoral, and popliteal veins. (j&k) the CTV at 1 month after endovascular POT demonstrated good visualization of the popliteal vein and DPTV (red arrow mark) with restoration of blood flow in the lumen compared with the pre-operative condition.
The thrombus was sufficiently removed before our proposed thrombolytic method began. Angiogram of iliofemoral and popliteal veins was used to determine the extent of the thrombus and guide further endovascular intervention. In all patients, we initially performed PCDT and/or manual aspiration thrombectomy (MAT) to remove the fresh thrombi. The ANGIOJET™ peripheral thrombectomy system (Boston Scientific, USA) on the drug spray mode was used for PCDT. A total of 0.2 MIU of urokinase (UK) (Tianpu, China) was dissolved into 100 ml of stroke-physiological saline solution, which was sprayed on the thrombus site. Then the system was reset to the aspiration mode 15 min after spraying to aspirate the thrombus segment by segment. MAT was performed with a 10 F catheter (OptEase, Cordis, USA) by aspirating through the catheter using a 20 mL syringe while gradually pulling the catheter out. This process was repeated until most of the fresh thrombus was removed. Following aspiration of the thrombus, angiogram was repeated to confirm restoration of in-line blood flow.
Percutaneous transluminal angioplasty (PTA) was performed through inflation of balloon in the stenosed or occluded segment of the iliac vein. During angioplasty, iliac vein compression was determined by the balloon contour under fluoroscopy, and if the stenosis of the residual iliac vein was more than 50% of the venous lumen, a stent was inserted. The length and number of stents were selected according to the length of the stenotic lesion on venography, and the stent diameter varied from 12 to 16 mm depending on the intraoperative 3D imaging assessment. According to the intra-operative linear flow recovery, the POT methods were chosen as follows: CDT was used if linear flow was not restored intra-operatively or CVC was used if linear flow was restored intra-operatively.
CVC procedure
After the PMT operation, the previous BTK venous vascular sheath was replaced with a one-lumen 5 F CVC (Teleflex, Arrow, USA) for POT therapy. Thereafter, all patients underwent CVC-directed thrombolysis with continuous administration of UK at 0.2–0.4 MIU/8–12 h using a portable syringe pump (Fornia, China) in the clinic for 1–5 consecutive days (). Oral rivaroxaban was also administered at 15 mg twice per day to prevent re-thrombosis. Vital signs and the puncture site were monitored daily, and hemoglobin, fibrinogen, blood platelet count, D-dimer, and activated partial thromboplastin were monitored twice a day for each patient. Active ankle pump exercise, passive massage of the calf, early bed removal, and rehabilitation were encouraged. Any definitive or suspected bleeding during thrombolysis was properly managed.
Figure 2. The process of CVC thrombolysis. (a&b) the vascular sheath of the PMT thrombectomy access was replaced by a 5 F one-lumen CVC secured with transdermal sutures. (c&d) the thrombolytic drug in the reservoir bag was loaded into the portable infusion pump, which was adjusted to the adequate dosage. (e) the infusion pump was connected to the CVC and turned on, which allowed patients to freely move their lower limbs and even ambulate during the period of thrombolysis.
Upon the judgment of the attending surgeons, POT therapy was discontinued if the limb swelling was completely resolved, elevated plasma D-dimer levels returned to normal levels, any severe thrombolysis-related complications like major bleeding had occurred, the value of fibrinogen dropped to a dangerous level (<1.0 g/L), or the patient had autonomously decided to terminate the treatment. Afterward, venography was performed through the CVC in each patient to determine the effects of thrombolysis. The venogram was reviewed carefully and graded on the scores from seven segments according to a modified standard: grade I, indicating less than 50% reduction in thrombus size; grade II, indicating 50–90% reduction in thrombus size; and grade III, indicating more than 90% reduction in thrombus size. The study considered grades II and III (≥50%) of thrombolysis as procedure success (Citation26). The IVCF was retrieved from the contralateral femoral venous access if the filter did not capture any migratory thrombus or developed filter-related thrombosis. Finally, the CVC was removed immediately after POT, and hemostasis was obtained by manual compression on the puncture site.
Postoperative medical management
A six-month oral anticoagulation therapy with rivaroxaban was prescribed to treat residual DVT and prevent thrombotic development in the stent. Compression stockings were also used to prevent PTS from occurring. The dose of rivaroxaban was 30 mg/day for the first 21 days and then 20 mg/day for the remaining days. All patients underwent ultrasound examination of both the lower limb veins and iliac veins at 1, 6, and 12 months, and the Villalta score and venous CTV were recorded at 1 and 12 months after the procedure.
Statistical analysis
Continuous data are expressed as mean ± standard deviation, and all data were analyzed using SPSS, version 26.0 (IBM, SPSS, Inc., IL)
Results
A total of 39 patients with IFDVT were included in this study. There were more female patients (n = 22, 56.41%) than male patients. The mean age of all included patients was 61.40 ± 14.40 years, and the mean BMI was 24.11 ± 3.38 kg/m2. Among the included patients, 46.15% had different risk factors, such as recent surgery and fracture. Most of the patients in the study involved the left side DVT (n = 32, 82.05%) with a symptom duration of 4.10 ± 2.66 days. According to the grading, 29 patients (74.36%) were classified as having Grade III thrombi (see ).
Table 1. Patients’ characteristics.
Operation
The mean waiting time from admission to CVC placement was 1.56 ± 1.35 days. Apart from 4 patients who already had an IVCF before this admission, 35 patients received IVCF before PMT-based thrombus removal and had the filter retrieved after thrombolytic procedures with a mean in-place duration of 3.72 ± 1.08 days; 32 (91.43%) of these patients had successful removal immediately following thrombolysis, and 3 kept the filters in place until 20–30 days after discharge due to captured thrombus by the filter (). Thrombus aspiration was performed for all 39 patients, who were further stratified as 17 with MAT alone, 14 with PCDT alone, and 8 with PCDT in combination with MAT. Thirty-two patients (82.05%) had May‒Thurner syndrome (MTS), and 29 (90.63%) of these patients underwent adjuvant PTA with stent placement, of whom 17 patients required only one stent placement, 7 required two stents, and 5 patients had three stents placed in either the common iliac vein, the common femoral vein, and in between. The success rate of the technique was 100%, and the thrombosed veins all regained linear blood flow after thrombolysis.
Table 2. Details related to the operation.
Before CVC placement, intra-operative saphenous vein angiography was preferred for access in 66.67% of patients. Since the thrombosis existed at the popliteal vein access in 22 of 39 patients, it was necessary to relocate the puncture site in a healthy intrapopliteal deep vein. Of all the access sites, 58.97% were located in the PeV, 25.64% in the PPTV, 10.27% in the ATV, and 5.13% in the DPTV, which facilitated patient activity after CVC-directed thrombolysis.
The mean operative duration from IVCF placement, thrombus removal, PTA, stent placement, and CVC placement was 122.97 ± 32.9 min, and the intra-operative bleeding volume was 193.03 ± 66.99 ml. There were no major intra-operative complications that resulting in aborting the procedure, and blood transfusion was not needed for any of procedures. One patient presented with minor complications of chills and discomfort presented during thrombus aspiration, and 2 patients reported mild lower back pain during stent placement.
CVC thrombolysis
The mean duration of thrombolysis for CVC was 3.69 ± 1.08 days, and the total UK dose was 2.27 ± 0.71 MIU (). Four patients (10.26%) developed minor bleeding complications, including one transient blood in urine, one inguinal hematoma formation, and two bleeding at the puncture site, without transfusion required. There were no new peri-operative pulmonary embolisms, intracranial hemorrhages, or deaths associated with thrombolysis.
Table 3. Outcomes during hospitalization.
The total length of stay (LOS) in the hospital was 5.82 ± 2.21 days, of which 29 patients (74.36%) were discharged one day after CVC thrombolysis. Thrombolysis was completed in 94.87% of patients (≥90%) and partially completed in 5.13% (<90%). None of the patients underwent thrombectomy twice or more. Thrombectomy failure and all-cause death were not observed. During hospitalization, the average cost of all interventions was $13,562.25.
Follow-up and outcome assessment
All included patients were followed up for at least one year until August 10, 2022. One patient developed mural thrombosis along the iliac vein stent, which was continuously treated with rivaroxaban, and disappeared at the 12-month follow-up. The patients were given rivaroxaban after CVC-directed thrombolysis with a mean duration of 6 months. None of the patients required re-thrombolysis or was admitted to the hospital for recurrent venous thrombosis. At the 12-month follow-up, the incidences of venous patency rate and PTS were 97.44% and 2.56%, respectively ().
Table 4. One-year follow up.
Discussion
This present study reports a novel POT method that can be used to administer thrombolytic drugs continuously through a CVC with a portable syringe pump to achieve early ambulation during the POT procedure. We have coined this new method as “walking thrombolysis.” This novel approach possesses several advantages (Citation1): Compared with conventional CDT catheters, CVC is shorter and more flexible, and does not require a vascular sheath, resulting in lower incidence of catheter-induced thrombosis, catheter kinking or migration, or other catheter-related complications (Citation2); CVC-directed thrombolysis does not require the patients to be confined to their bed. Thus, CVC thrombolysis can remarkably improve patient comfort and compliance (Citation3); This method allows for early rehabilitation training and the contained use of a compression and can improve the efficacy of thrombolysis via a CVC externally connected to a portable syringe pump. Furthermore, our study found that the new POT method achieved complete thrombolysis in 94.87% of patients, that was higher than 37%~68% of conventional CDT methods in most other studies (Citation20,Citation27–29). We also report that 97.44% of patients were free from PTS during the one-year follow-up, which was significantly higher than that in the ATTRACT study (Citation22). Taken together, our study indicates that this novel thrombus removal procedure is effective and provides favorable long-term outcomes.
Most studies have only focused on the efficacy of thrombus clearance by different PMT methods but did not give enough attention to the effectiveness of POT. Thus, there is no consensus on procedural details of POT. CDT has been one of the most commonly used approaches to treatment IFDVT due to its high efficiency (Citation20,Citation21), and its access sheath has been also reported to be used for postoperative thrombolysis (Citation30). In this study, CVC replaced the CDT or access sheath as a new thrombolytic approach. The ATTRACT trial infused rt-PA for no longer than 24 h if residual thrombus was present after PCDT (Citation22). However, the results of that study did not reach significance with regard to lowering the high incidence of PTS even in the premise of effective thrombus removal during operation, which made us speculate whether the POT was sufficient. Some other studies reported a longer thrombolytic time of 4.5 days after CDT (Citation27), here, we report a thrombolytic time of 3.69 ± 1.08 days, which suggests the longer POT duration may affect PTS development.
During our POT procedure, thrombolytic drugs were administered until symptoms were completely relieved in the absence of complications. Then the thrombolytic duration was determined and adjusted using plasma D-dimer levels as a predictive value of the thrombolytic effect (Citation31,Citation32). With regards to thrombolytic dosage, our POT protocol uses a much lower UK dosage of 2.27 ± 0.71 MIU compared to doses reported in other studies (Citation33,Citation34). The low dose of thrombolytic agent was justified in our study with the early ankle pump exercise and early ambulation, which can promote timely venous blow, thereby potentially increasing the efficacy of thrombolysis. All patients in our study underwent two or more venographies during POT and had a significant reduction in residual thrombus burden in the last venography, which further confirmed the effectiveness of the CVC-directed POT.
Bleeding complications remain a major risk factor for early thrombus removal strategies. CDT has been associated with increases in risk of bleeding, chance of blood transfusion, and incidence of procedure-related complications (Citation35,Citation36). Our present study found that CVC, as the novel thrombolytic administration pathway, significantly reduced the incidence of these CDT-related complications. We only found two incidences of CVC indwelling-related minor bleeding and two incidences of thrombolytic therapy-related minor bleeding. However, well-designed comparative studies with CDT are required to verify the safety of CVC-directed POT.
The implementation of the enhanced recovery after surgery (ERAS) protocol in DVT management is noteworthy. The need for strict bedrest and immobilization during post-PMT CDT is disadvantageous for ERAS in DVT patients; however, our CVC-based method offers early ambulation as well as rehabilitation training during CVC-directed thrombolysis. The median hospital LOS for our cohort was 5.82 ± 2.21 days, which is lower than the LOS reported in many other studies (Citation20,Citation21,Citation33,Citation37). It demonstrates that CVC-directed POT can enhance postoperative recovery and shorten LOS. Overall, the CVC-directed POT method in this study was safe, effective, and comfortable for DVT patients.
Several crucial premises are required for this CVC-directed POT: First, BTK venous access should be established to facilitate postoperative rehabilitation. Second, antegrade in-line flow from the popliteal vein to the IVC should be restored to maintain the effective thrombolytic concentration. Recent studies have shown that BTK venous access is feasible and safe for CDT placement for lower extremity DVT (Citation30,Citation37–39). Up to 20% of acute calf venous thrombosis may spread to the proximal deep vein, which significantly contributes to the development of subsequent PTS (Citation40,Citation41). BTK access provides sufficient space to clear the thrombus in the distal segments so that the incidence of PTS can be significantly reduced (Citation39). Surprisingly, 74.36% of the thrombi in our cohort involved the popliteal vein, so the establishment of BTK access was justified. Moreover, thrombus clearance from the popliteal vein trunk can promote relief of calf swelling symptoms postoperatively, which may restore ideal inflow velocity and improve thrombolytic efficacy. Third, the puncture site of BTK is located in front of the calf, which is more suitable for supine operation and postoperative care. Finally, BTK access does not affect knee movement, thus providing sufficient convenience for early postoperative ambulation and rehabilitation training. Patients can even walk freely during thrombolysis without the restrictions of catheters and electronic pumps.
Stent placement is also a vital step to eliminate venous stenosis and compression and restore in-line flow. In this study, 82.05% of patients were involved in MTS, of which 90.63% underwent assisted PTA and stenting to facilitate linear venous flow with good outflow tracts and a technical success rate of 100%. Our data are consistent with the outcomes reported in other studies, which demonstrated that more than 70% of patients with DVT developed proximal iliac vein stenosis (Citation42). Meanwhile, many studies have shown that residual stenosis after MTS was a risk factor for the recurrence of DVT and that it increases the incidence of PTS, which should be further treated with stenting to improve prognosis (Citation43,Citation44). Therefore, screening for iliac vein stenosis in patients with DVT and stent management can contribute to better prognosis after MTS.
The limitations of this study mainly include the following points. First, the small sample size, retrospective nature and single-arm nature of the study mean that it may not provide strong evidence. Second, since the patients selected for this study only used UK as a thrombolytic agent, the conclusions should be cautiously applied to other thrombolytic therapies. Third, the follow-up duration for the patients in this study was only one year. Thus, a study with more patients and longer follow-up period should be done to confirm the clinical outcomes of CVC-directed CDT in patients with DVT.
Conclusions
In summary, CVC-directed thrombolysis with a portable syringe pump can be used as a feasible, safe, and effective thrombolytic approach after PMT for IFDVT. This new method reduces the dose of the thrombolytic agent, minimizes thrombolysis-related complications, and improves the efficacy of thrombolysis. Collaterally, our method can also enhance early ambulation and rehabilitation training during treatment, which promotes patient comfort and shortens the recovery period after the procedure. Altogether, CVC-directed thrombolysis can be considered as an alternative to the conventional CDT approach in POT treatment.
Author contributions
QZ and YZ designed the study. FL, XW, HT and BT collected and analyzed the data. BT and QZ wrote the manuscript. All authors approved the final manuscript.
Ethics approval
The study was approved by the ethical committee of The First Affiliated Hospital of Chongqing Medical University and individual consent for this retrospective analysis was waived.
Acknowledgments
We thank all the members involved in this work.
Disclosure statement
The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.
Data availability statement
The data sets used and/or analyzed during the current study are available from the corresponding author upon request.
Additional information
Funding
References
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