Analysis Of Risk Factors And Therapy On Lead-related Venous Thrombosis Complicated With Cardiovascular Implantable Electronic Device

Backgroud: Cardiovascular Implantable Electronic Device(CIED) including Permanent Pacemaker(PPM), Implantable Cardioerter Defibrillator(ICD) and Cardiac Resynchronization Therapy(CRT) and now is widely used in the treatment of patients with severe slow arrhythmia, sustained rapid ventricular arrhythmia and heart failure with ventricular systolic dyssynchrony. Percutaneous intravenous implantion is the most common method to implant CIED leads. In recent years, many letters reported that implanted leads can cause venous thrombosis, followed with pulmonary embolism(PE) caused by the caducous blood clots and vein stenosis or occlusion caused by thrombosis can lead to superior vena cava syndrome(SVCS) and other complications,and it is also difficult to replace or upgrade CIED system.Objective: Our study is based on the patients with CIEDs, aimed to investigate risk factors of CIED lead-related venous thrombosis and compare the differences of CIED lead-related venous thrombosis after different drug therapy regimens, which provides the basis for clinical prevention and treatment.Methods: We enrolled consecutive patients with CIED, who were admitted to hospital for the first time of PPM, ICD and CRT(including CRT-P and CRT-D) implantation, from September 2013 to December 2015 in the Department of Cardiology, PLA General Hospital. All of them were undergone bilateral upper limb vein, subclavian vein and the superior vena cava vascular ultrasound testing respectively before and 1/4,1,3, 6 months after implantation. According to the result of postoperative vascular ultrasound, they were assigned to thrombosis group and non-thrombosis group. Their clinical data were collected and we compared the differences between two groups. Logistic regression analysis was utilized to assess the relationship between clinical datas and venous thrombosis. The patients in thrombosis group were divided into two groups with different drugs: (1)warfarin group: patients initial treated with warfarin combined with low molecular weight heparin(LMWH) for 3～5 days, when international normalized ratio(INR) reached 2.0,warfarin alone long-term oral treatment, then regularly monitoring to ensure that INR is between 2.0-3.0; (2) new oral anticoagulants(NOACs) group: patients treated with dabigatran(110mg bid). Digital subtraction angiography(DSA) was performed in both of two groups paitents before and 1, 3, 6, 12 months after treatment respectively to evaluate whether the vascular stenosis degree changed obviously. According to measure the reducing percentage of vascular caliber from vascular stenosis diameter to normal proximal vascular by QAngio XA, vascular stenosis degree was divided into four levels: <50% is mid, >50% and <70% is moderate, >70% and <100% is severe and 100% is totally occluded. Compared with prethearpy, we defined vascular stenosis degree reduced one or more level as effective, no improve or worsen one or more level as invalid.Results: A total of 164 cases with CIED were enrolled in our study. 56 cases with CIED lead-related venous thrombosis were selected as thrombosis group,while the other 108 patients who were never found CIED lead-related venous thrombosis as non-thrombosis group. We found that: (1) There was no significant differences in clinical characteristics such as age, sex, body mass index(BMI), smoking, hypertension, history of myocardial infarction(MI), stroke history between two groups(P>0.05). (2) There was statistical differences in the percentage of patients with atrial fibrillation(AF), implanted defibrillator lead, taking anticoagulant drugs and glycosylated hemoglobin(HbAlc), left ventricular ejection fraction(LVEF), the times of venipuncture, operation time, lead numbers(P<0.05).(3) Logistic regression analysis showed that AF(OR=15.816;P<0.05),HbA1c(OR=2.799;P=0.003), times of venipuncture(OR=3.438; P<0.05) and operation time(OR= 1.054;P<0.05) were risk factors for CIED lead-related venous thrombosis,taking anticoagulant drugs(OR=0.016 ; P<0.05) was protective factor. (4) Anticoagulation therapy can significantly reduce vascular stenosis degree caused by CIED lead-related venous thrombosis and with the extension of treatment time, the treatment efficiency gradually increased. One year after drug treatment, treatment effectiveness of NOACs group was obviously higher than that of warfarin group (P<0.05).Conclusion: Our study found that AF, hyperglycemia, times of venipuncture and operation time were the independent risk factors for CIED lead-related venous thrombosis;Aticoagulants had obvious therapeutic effect for CIED lead-related venous thrombosis and treatment effectiveness increased with prolonged treatment; NOACs group’s long-term effectiveness is better than that of warfarin group.