| Objective : To compare the effectiveness and safety of Fogarty balloon catheter thrombectomy with catheter-directed thrombolysis in the treatment of acute lower limb ischemia.Methods: The clinical data of 86 patients（86 limbs）admitted to the Department of Vascular Surgery of the First Affiliated Hospital of Dali University from June 2018 to December 2021 with acute lower limb ischemia and treated with Fogarty balloon catheter thrombectomy or catheter-directed thrombolysis were retrospectively analyzed,including:patients’ general information,risk factors,plane of vessel occlusion,duration and degree of ischemia,postoperative bed rest,length of hospital stay and cost of treatment were included.All patients with acute lower limb ischemia were divided into a Fogarty balloon catheter thrombectomy group and a catheter-directed thrombolysis group according to the procedure.By comparing patients’ 30-day postoperative mortality,amputation rate,incidence of complications（surgical site bleeding,hematoma,lymphatic leak,osteofascial compartment syndrome,incisional infection,cerebral hemorrhage,and heart failure）,changes in anklebrachial index and pain relief before and 3 days after surgery.The Cooley efficacy criteria were used to evaluate the degree of improvement in lower limb ischemia at discharge in patients with Rutherford ischemia grade Ⅱ,and to follow up the improvement in intermittent claudication time and distance at 3 months after discharge to comprehensively evaluate the effectiveness and safety of the two treatment modalities.For patients with amputation or toe amputation,we divided them into amputation and non-amputation groups.Factors that may affect amputation,including laboratory indicators at admission,age,ischemic grading,treatment modality,ischemic time,risk factors and gender were firstly analysis as single factors,while statistically significant indicators were then included in a binary logistic model for multi-factor analysis,which ultimately led to the conclusion that patients with acute lower limb ischemia were affected by the independent risk factors for amputation.outcome: A total of 86 patients（86 limbs）with acute lower limb ischemia were included,of which 39 limbs were treated with Fogarty balloon catheter thrombectomy and 47 limbs were treated with catheter-directed thrombolysis.（1）Improvement in lower limb ischemia at discharge in 75 patients with Rutherford ischemia class II: the percentage of patients who recovered from ischemia due to arterial embolism was greater in the Fogarty balloon catheter thrombectomy group than in the catheter-directed thrombolysis group（71.43 % vs 28.57%）,and the percentage of patients who recovered from ischemia due to arterial thrombosis was lower in the Fogarty balloon catheter thrombectomy group than in the catheter-directed thrombolysis group（57.89% vs 74.29%）,and the difference was statistically significant（p <0.05）.（2）Among 86 patients with acute lower limb ischemia,the mean ankle-brachial index was higher in the Fogarty balloon catheter thrombectomy group（0.80 ±0.16）than in the preoperative group（0.28 ± 0.11）at 3 days after surgery,with a statistically significant difference（p<0.05）;the mean ankle-brachial index was higher in the catheter-directed thrombolysis group（0.82±0.21）than in the preoperative group（0.32±0.14）at 3 days after surgery,with a statistically significant difference（p<0.05）The difference was statistically significant（p<0.05）.（3）The incidence of osteofascial compartment syndrome was higher in the Fogarty balloon catheter thrombectomy group than in the catheter-directed thrombolysis group（12.82% vs 2.13%）and the incidence of bleeding was lower in the Fogarty balloon catheter thrombectomy group than in the catheter-directed thrombolysis group（2.56% vs12.77%）,both differences being statistically significant（p<0.05）.（4）The time spent in bed was shorter in the Fogarty balloon catheter thrombectomy group（1.49±0.68 days）than in the catheter-directed thrombolysis group（3.30±1.27 days）,and the hospital cost was lower in the Fogarty balloon catheter thrombectomy group（RMB 25,489.80 ± 11,804.95）than in the catheter-directed thrombolysis group（RMB 30,618.56 ± 13,586.79）,with both differences being statistically significant（p < 0.05）.（5）There was no statistically significant difference in amputation rate（17.95% vs 8.51%）and mortality rate（0% vs 2.13%）between the Fogarty balloon catheter thrombectomy and the catheter-directed thrombolysis group（p>0.05）.（6）The prognosis of patients with a Rutherford ischemia classification of Ⅱ according to the Cooley’s efficacy criteria for different ischemia times under the two procedures was not statistically significant between the two groups（p > 0.05）.（7）No statistically significant difference in postoperative pain relief between the Fogarty balloon catheter thrombectomy group and the catheter-directed thrombolysis group（p>0.05）.（8）No statistically significant difference in length of stay between the Fogarty balloon catheter thrombectomy group and the catheterdirected thrombolysis group（p>0.05）.（9）There were 11 cases of amputation or toe amputation in 85 patients with acute lower limb ischemia（except for one fatal patient）,with an amputation rate of 12.94%,including 6 cases of above-knee amputation,3 cases of below-knee amputation,and 2 cases of foot or toe amputation.Univariate statistical analysis of amputations showed that phosphocreatine kinase >195 U/L,ischemic grading（grade IIb and III）,age ≥60 years,ischemic time >48 h,and C-reactive protein >10 mg/L were risk factors for amputation（p<0.05）;multifactorial analysis by incorporating statistically significant indicators of single factors into a binary logistic model showed that ischemic grading（grades IIb and III）,and phosphocreatine kinase >195 U/L,age≥60years,were independent risk factors for amputation（p< 0.05）.（10）During the 3-month follow-up period,all 74 patients completed the follow-up except for 1 death and 11 amputations.There was no statistically significant difference in the improvement of intermittent claudication between the Fogarty balloon catheter thrombectomy group and the catheter-directed thrombolysis group（p > 0.05）.Conclusion:1.Both Fogarty balloon catheter thrombectomy and catheter-directed thrombolysis are effective and feasible methods of treating acute lower limb ischemia.The specific treatment modality should be based on a comprehensive assessment of the patient’s ischemic classification,the cause of the ischemia and his or her underlying disease.2.The incidence of compartment syndrome in the Fogarty balloon catheter thrombectomy group was higher than in the catheter-directed thrombolysis group,and the incidence of bleeding in the catheter-directed thrombolysis group was higher than in the Fogarty balloon catheter thrombectomy group,and the differences were statistically significant,the differences in amputation rate and mortality between the two groups were not statistically significant.3.In this study,the amputation rate of patients with acute lower limb ischemia was 12.94%.Rutherford ischemia grade Ⅱb and Ⅲ,creatine kinase > 195U/L and patients aged ≥ 60 years were independent risk factors for amputation. |
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