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Catheter-Directed Thrombolysis via Great Saphenous Vein for Mixed Deep Veinous Thrombosis of Lower Extremity Xicheng Zhang1,2, Xiaoqiang Li1, Zhaolei Chen2, Guangrui Pan2, Qingyou Meng1, Jianjie Rong1 [Abstract] Objective: To explore the feasibility of catheter-directed thrombolysis(CDT) via great saphenous vein-perforater vein to deep vein for treatment of mixed lower extremity deep veinous thrombosis(DVT) , and to evaluate its clinical efficacy. Methods: We performed this retrospective analysis of the clinical data in 25 cases with acute mixed lower extremity DVT. All the patients were punctured through ankle great saphenous vein, and the catheter were delivered through perforater vein into deep vein for thrombolysis. The thrombolysis efficacy was evaluated by angiography.For some patients with residual iliac vein stenosis or occlusion, balloon-dilatation and stent placement were performed through great saphenous vein or femoral vein. Results: In 25 patients, the catheters were successfully delivered into deep veins through great saphenous vein-perforater vein , without severe complications. The thrombolysis time through catheter is 5-7 d. The symptoms such as swollen of the lower limb and pain improved significantly after CDT, the circumference difference of thigh and calf significantly reduced, statistically significant (P<0.01, P<0.01). The vein patency scores are different before (11.56±0.917) and after catheterization (2.64±2.018), statistically significant (P<0.01). The improvement of vein patency was 30%~100%,averaged at (76.66±18.10) %. The stents were delivered through great saphenous vein of lesion side in 8 patients, through femoral vein to iliac vein in 3 patients.21 patients were followed up for 3-12 months. One patient received intra-lumenial therapy due to re-stenosis distal to the stent. There was no recurrence of lower extremity swollen for the rest 20 patients. Conclusion: CDT via great saphenous vein for mixed lower Author affiliation:Department of Vascular Surgery, Second Hospital Affiliated to Soochow University, 215004 Department of Vascular Surgery, Clinical Medical school of Yangzhou University, 225001 Corresponding author:Xiaoqing Li. E-mail:[email protected] extremity DVT is a simple procedure, easy to perform, with minimal invasion and high thrombolysis efficacy. It is an optional, safe, and practical thrombolysis in the clinic. [Key word] Deep veinous thrombosis ; Catheter-directed thrombolysis; Great saphenous vein; perforater vein Deep venous thrombosis (DVT) is common in the clinic. Its incidence increases every year. Acute DVT may cause fetal pulmonary embolus (PE), and affect the quality of patient life in the late stage due to the high incidence of post-thrombosis syndrome (PTS). In recent years, catheter-directed thrombolysis (CDT)has been used to treat acute DVT and revealed good medium and long term efficacy, and reduced incidence of PTS 1-2 . CDT mainly performed through popliteal vein, the small saphenous vein and the contralateral femoral vein. We performed CDT through great saphenous to vein perforater vein in 25 patients with acute mixed lower extremity DVT, who were admitted in our department during Oct of 2011 to Dec of 2012, with great success. Herein, we are reporting as follows. Material and Method 1. General information There were 25 patients in this group totally, 11 males and 15 females, aged at 28~68 years. The onset of the disease was 2~14d. All of cases are lateral DVT,19 at the left and 6 on the right. Clinical presentations were lateral limb swollen, pain, dysfunctional mobility, without significant chest pain, or dyspnea, or hemoptysis or other symptoms of pulmonary embolus. The circumference difference of thigh at lesion side and healthy side was 5.6~11.2cm,averaged at 7.696±1.576cm;the circumference difference of calf was 2.5~6.1cm,averaged at 4.420±1.117cm. All the patients were confirmed for mixed DVT with color doppler or CT angiography. 2. Management 2.1 Placement of inferior vena cava filter:to prevent PE during thrombolysis, Page 2 of 9 all the patients were placed recyclable(Optease,USA Cordis)or permanent inferior vena cava filter(TrapEase,USA Cordis). Puncture femoral vein of the healthy side, perform angiography in inferior vena cava, label bilateral renal veins, and place the filter. If the thrombus involved the inferior segment of inferior vena cava, puncture through jugular vein, and place the filter above the thrombus. 2.2 Thrombolysis via great saphenous vein: Puncture great saphenous vein at the ankle of the lesion side. First, place tourniquet at the upper middle segment of the calf. Dorsalis pedis superficial vein was punctured for injection of contrast. Take a look at the perforater vein between the shallow vein and deep vein. If this perforater vein is good for catheter, pass through it; or else, go through small saphenous vein. After great saphenous vein is filled up, puncture great saphenous vein at the ankle, place a 5F sheath, and then deliver the tubing through the sheath, inject some contrast. Under the vision of “road map” track, select calf perforater vein, match the guide wire with the tubing, and then deliver the guide wire into calf deep vein via perforater vein, and then deliver the guide wire via DVT into inferior vena cava. Withdraw the guide wire; deliver Unifuse-catheter with 50cm of thrombolysis segment (AngioDynmics inc. USA),with the tip close to the proximal side of the thrombus. Fix the exterior catheter. 2.3 Thrombolysis and anti-coagulation: First, iv. push urokinase 200 thousand u into Unifuse catheter as the initial dosage, and then continues infuse urokinase through mini-pump at 200~400 thousand U/h, and exam the thrombolysis every 24 hr by angiography. Use low molecular heparin subcutaneously for anti-coagulation, 4000U/12h. Monitor coagulation regularly. 2.4 Management after thrombolysis: for those with complete dissolved thrombus with CDT, those with severe residual iliac vein stenosis or occlusion were treated with intra-lumenal therapy via great saphenous vein or femoral vein of the lesion side, suggesting with balloon-dilatation and stent placement. All patients with CDT should take warfarin orally for at least 3~6 months, and followed up for coagulation parameters regularly, wear elastic stockings, and take oral flavonoids. Page 3 of 9 3. Efficacy evaluation 3.1 Clinical efficacy evaluation: Observe the symptom improvement of the limb with lesion, including swollen of the lower limb, soar and pain etc. Measure the circumference 10cm above and under the knee, calculate the circumference difference of thigh and calf between the lesion side and healthy side. 3.2 Patency of vein:By using vein patency score, evaluate the outcome of thrombolysis 3 as follows: Divide the lesion limb deep veins into inferior vena cava, iliac general vein, iliac external vein, common femoral vein, superficial femoral vein upper segment, superficial femoral vein lower segment and popliteal vein, totally 7 segments. According to the results of angiography, score the vein patency of the above 7 segments and add up. Complete patency was scored as 0, partial for 1, and no patency for 2. Vein patency improvement rate=( vein patency score before thrombolysis-vein patency score after thrombolysis) / vein patency score before thrombolysis ×100%. Improvement rate of vein patency<50% was regarded as thrombus dissolve grade I; Improvement rate of vein patency 50% ~ 90% was regarded as thrombus dissolve grade II;Improvement rate of vein patency> 90% was regarded as thrombus dissolve grade III4. 4. Statistical analysis SPSS19.0 software was used for statistical analysis; quantitative data were presented as X±S. The circumference difference of bilateral limbs and the score value of vein patency were examined with paired t test;P<0.05 was regarded statistically significant. Results 1. Clinical efficacy: These 25 patients were successfully placed catheter thrombolysis via great saphenous vein. After the therapy, the symptoms such as swollen of the lower limb and pain improved significantly. The circumference difference between the lesion side and healthy side reduced dramatically. The Page 4 of 9 circumference difference of the thigh reduced from 7.696±1.576 cm to 2.032±0.824cm,statistically significant(T=17.081,P<0.01);The circumference difference of the calf dropped from 4.420±1.117cm to 1.304±0.662cm , statistically significant(T=12.045,P<0.01). 2. Medications and complications:The treatment time of CDT for these patients was about 3 ~7d,averaged at 4.80±1.38d,the total dosage of urokinase was 150×104 ~525×104U,averaged at (322.8±110.28)×104U. There were four cases with complications (16%),including one case of oozing blood at the puncture site, 2 cases of hematuria, and one case of mild hemoptysis. There was no symptomatic PE or other severe complications. 3. Angiography Comparison before and after CDT:Before CDT, perform deep vein angiography to evaluate the vein patency score. Before CDT, the vein patency score was 10~13, averaged at 11.56±0.917. After CDT, the score was 0~8, averaged at 2.64±2.018. There was significant difference for the score before and after CDT(T=19.029,P<0.01). The patency improvement rate was 30%~100%,averaged at(76.66±18.11)%. Among those, the vein patency improvement rate in 3 cases reached thrombus dissolve grade ( I 12%),14 reached grade II(56%),and 8 reached grade III(32%). 4. Subsequent therapy:Among these 25 patients,16 were discovered with severe stenosis or occlusion of iliac vein after CDT treatment with vein angiography, among which, 11 were treated with further iliac intra-lumenial therapy, with 8 via great saphenous vein and 3 via ipsilateral femoral vein and performed iliac vein angioplasty and stent placement. The patients took oral warfarin regularly after being discharged and followed up with coagulation parameters regularly. Twenty-one patients were followed up, for about 3~12 months. 8 months after surgery, one patient presented with left lower limb bulge discomfort after long standing, and was found with imaging examination that there was severe stenosis at the distal of iliac vein stent. The patient was treated with intralumenal therapy and the symptoms were relieved. There was no other recurrence of lower limb swollen. Page 5 of 9 Discussion Compared with systemic anti-coagulation, thrombolysis, CDT for lower limb DVT delivers the thrombolytic drugs directly into the thrombus via tubing. Not only it has a high thrombolytic rate, it also protects vein valve function, and reduces the incidence of thrombus sequela 1,5-6. In china, in the second edition of the guideline for diagnosis and treatment of lower limb DVT in 2012, it was recommended CDT as the first choice of treatment for DVT7. In the commonly used CDT road, different centers use different roads for cathetering with different experiences. The common used roads include via ipsilateral popliteal vein, small saphenous vein, contralateral femoral vein, and jugular vein etc. Among them, popliteal vein and small saphenous vein were often used 8. Popliteal vein puncture has the following flaws: the patient should be supine when performed, which made it difficult for the old, weak and after trauma; it is easy to injure popliteal artery and tibia nerve during puncture. Furthermore, the thrombolysis catheter were delivered via popliteal vein to deep vein, making it difficult for the thrombus in deep vein distal to popliteal vein dissolved, unable to supply good entrance, and reduce the rate of thrombolysis. Moreover, due to the injury to popliteal vein and catheter placement, it may cause subsequent thrombus worse 9-10 . The path via small saphenous vein can solve this problem very well, which makes it a good path. But small saphenous vein has many variances, the locations vary, the successful rate of puncture was low, and it often requires a minor incision for cathetering, and it often requires the patients adduct and internal rotate the lesion limb, and it is difficult to be exposed, the incision for cathetering is easy to ooze blood and it is very inconvenient for nursing. Cragg or Armon et al9-10 had reported successful cases with catheter-directed thrombolysis punctured shallow vein of calf and catheter delivered via perforater vein between superficial and deep vein of calf. In our practice, we found that puncturing great saphenous vein at ankle via perforater vein can be used as routine road. This is because that the location of great saphenous vein at the ankle is rather stable, often had compensated dilatation after DVT, it is easy to puncture, and with a high Page 6 of 9 successful rate. Furthermore, there is no important structure along with great saphenous vein, there is not many complication for puncture, there is little oozing of blood after the procedure and it is convenient for nursing. The patient can move without specific limitation after the procedure. There are many perforater veins to the deep vein for great saphenous vein above ankle and below the knee. Injection of contrast into dorsalis pedis superficial vein before the procedure, and evaluate the feasibility of placement of catheter in perforater vein. Generally speaking, the perforater vein will compensate and dilate after DVT. The mixed DVT is the most common 11. Therefore, it improved the successful rate of cathetering in perforater vein via great saphenous vein. Those with up-sloping inserted into perforater vein to deep vein without curve had a high successful rate. If there are several perforater veins, those with low surface branch veins should be chosen for getting into deep vein, to increase the dissolving range of deep vein thrombus of the calf. For those without parforater vein displayed with angiography or those tiny, downsloping or curvedly into deep vein, the successful rate was low. The puncture path should be given up. Choose small saphenous vein to catheter. Although cathetering via great saphenous vein perforater vein has many advantages, there are shortcomings. Not every patient can be placed successfully. According to our experience, mixed DVT patients can be cathetered via great saphenous vein, with a successful rate of 70%. Puncture via great saphenous vein at the ankle and go through perforater vein for CDT to treat lower limb acute mixed DVT made the catheter directly into deep vein below knee which improved the dissolved area of thrombus. Medication thrombolysis can set up good vein entrance and improve thrombolytic rate. This is a simple procedure with few complications, and easy for nursing afterword. It is a worthy option for good cathetering. References 1. Gasparis AP,Labropoulos N,Tassiopoulos AK,Phillips B,Pagan J,Chen Lo,et al.Midterm follow-up after pharmacomechanical thrombolysis for lower extremity deep venous thrombosis.Vasc Endovasc Surg,2009,43:61-8 Page 7 of 9 2. Enden T,Haig Y, Kløw NE,Slagsvold CE,Sandvik L,Ghanima W,et al.Long-term outcome after additional catheter-directed thrombolysis versus standard treatment for acute iliofemoral deep vein thrombosis (the CaVenT study): a randomised controlled trial. Lancet. 2012,379:31-8 3. Porter JM , Moneta GL. Reporting standards in venous disease : an update.International Consensus Committee on Chronic Venous disease.J Vasc Surg,1995,21:635-45 4. Protack CD,Bakken AM,Patel N,Saad WE,Waldman DL,Davies MG.Long-term outcomes of catheter directed thrombolysis for lower extremity deep venous thrombosis without prophylactic inferior vena cava filter placement.J Vasc Surg,2007,45:992-7 5. Enden T,Kløw NE,Sandvik L,Slagsvold CE,Ghanima W,Hafsahl G, et al.Catheter-directed thrombolysis vs. anticoagulant therapy alone in deep vein thrombosis:results of an open randomized,controlled trial reporting on short-term patency.J Thromb Haemost,2009,7:1268-75 6. Comerota AJ.Catheter-directed thrombolysis prevents post-thrombotic syndrome in patients with acute deep vein thrombosis in the upper half of the thigh.Evid Based Med,2012,17:182-3 7. Chinese medicine association surgery section vascular surgery group (written by Xiaoqing Li and Shenming Wang). Guideline for diagnosis and treatment of DVT (2nd edition). Chinese surgery journal,2012;50:611-4 8. Sharafuddin MJ,Sun S,Hoballah JJ, Youness FM, Sharp WJ, Roh BS.Endovascular management of venous thrombotic and occlusive diseases of the lower extremities.J Vasc Interv Radiol,2003,14:405-23 9. Cragg AH. Lower extremity deep venous thrombolysis: a new approach to obtaining access. J Vasc Interv Radiol,1996, 7: 283-8. 10. Armon MP,Whitaker SC,Tennant WG.Catheter-directed thrombolysis of iliofemoral deep vein thrombosis,A new approach via the posterior tibial vein.Eur J Vasc Endovasc Surg,1997,13:413-6 11. Guo Q, Tian J, Du G, Wang Y,Jiang S,Wang X, et al. Evaluation of the effect of Page 8 of 9 DVT on perforater vein under Color Doppler angiography. Chinese journal of medicine ultrasound. Electronic version, 2011,8:2153-9 Page 9 of 9