Comparison of Low-Dose Catheter-Directed Thrombolysis with and without Pharmacomechanical Thrombectomy for Acute Lower Extremity Ischemia.
Gandhi Sagar S,Ewing Joseph A,Cooper Emily,Chaves Jose Mauro,Gray Bruce H
Annals of vascular surgery
BACKGROUND:Catheter-directed thrombolysis (CDT) and/or pharmacomechanical thrombectomy (PMT) can dissolve/remove thrombus; PMT alone, however, may require the adjunctive use of CDT. The aim of this study was to compare the use of CDT with and without PMT for the treatment of acute lower extremity ischemia (ALI). METHODS:We retrospectively reviewed all patients with ALI who underwent CDT with or without PMT between January 2008 and April 2014 (n = 99). Patients with incomplete medical charts were excluded (n = 16). Remaining patients were divided into 2 cohorts: group 1 included patients who underwent PMT + CDT (n = 54); group 2 included those who underwent CDT alone (n = 29). Lesions were further characterized by anatomic location: iliac disease (n = 14), femoropopliteal disease (n = 53), tibial disease (n = 2), and multilevel disease (n = 14). Data collection included patient and limb characteristics, duration of treatment, complications, clinical outcomes, adjunctive interventions, and follow-up. RESULTS:No significant differences were seen between treatment groups in terms of patient characteristics, occlusion length and location, Rutherford class, median duration of ischemia time (P = 0.22), or mean lysis time (P = 0.58). Treatment groups were also similar with regard to outcomes, including periprocedure complications, patency, reintervention, limb salvage, and amputation-free survival. CONCLUSIONS:There was no different between PMT + CDT and CDT alone in terms of periprocedural complications or outcomes. In the quest to resolve ALI, initial thrombus extraction with PMT may not reduce the need, duration, or efficacy of CDT.
10.1016/j.avsg.2017.07.008
Comparative assessment of patient outcomes with intraluminal or subintimal crossing of infrainguinal peripheral artery chronic total occlusions.
Kondapalli Ananya,Jeon-Slaughter Haekyung,Lu Hua,Xu Hao,Khalili Houman,Prasad Anand,Armstrong Ehrin J,Brilakis Emmanouil S,Banerjee Subhash
Vascular medicine (London, England)
This study compares procedural complications and clinical outcomes between subintimal crossing versus intraluminal crossing during endovascular treatment of infrainguinal peripheral artery chronic total occlusions (CTO). We identified 1335 CTO interventions in 1001 patients from the multicenter Excellence in Peripheral Artery Disease (XLPAD) registry from January 2005 to October 2015. Outcomes included 30-day and 12-month all-cause death, non-fatal myocardial infarction or stroke, peripheral artery stent, or vessel, thrombosis (ST), need for any target limb endovascular or surgical revascularization, target limb major amputation and procedural complications. A subintimal crossing technique was necessary in 388 lesions (27% overall in 1335 lesions; 34% ( n=351) in 1023 femoropopliteal lesions, and 12% ( n=37) in 312 infrapopliteal lesions, p<0.01) with a lower procedural ( p<0.01) and technical ( p<0.01) success than the intraluminal in both femoropopliteal and infrapopliteal interventions. There were no significant differences in procedural complications, major adverse cardiac events, or clinically driven target limb revascularization at 1 year between the two groups, except a higher residual dissection rate in the subintimal crossing group than the intraluminal group in femoropopliteal target vessels ( p = 0.04).
10.1177/1358863X17735192
Subacute lower extremity arterial thrombosis; early outcomes of catheter directed thrombolysis with alteplase and importance of malnutrition assessed by CONUT score.
Sarı Münevver,Çakmak Ender Özgün,Karagöz Ali,Yılmaz Fatih,Aytürk Mehmet,Fidan Serdar,Alizade Elnur,Arslantaş Uğur,Tokgöz Hacer Ceren,Güner Zeynep Esra,Alıcı Gökhan,Özkan Birol,Pala Selçuk
Turk Kardiyoloji Dernegi arsivi : Turk Kardiyoloji Derneginin yayin organidir
OBJECTIVE:In this study, we aimed to report early outcomes of catheter-directed thrombolysis (CDT) with alteplase in patients with subacute limb ischemia and to assess whether there is a link between malnutrition (determined by Controlling Nutritional Status [CONUT] score) and response to thrombolysis and bleeding. METHODS:This was a retrospective study conducted between 2007 and 2020 with 118 patients with Rutherford class 3 (34.7%), class 4 (40.7%), and class 5 (24.6%) symptoms owing to infraaortic subacute thrombotic occlusion who were treated with catheter-directed thrombolysis. RESULTS:Immediate technical success (Thrombolysis in Myocardial Infarction [TIMI] grade 2/3) was achieved in 56%, overall technical success after all adjunctive procedures was seen in 83.9%. Clinical success was obtained in 74.5% within 30 days. Major bleeding occurred in 11.8%. When we excluded access site hematomas, the rate of major bleeding was 5.1%. In-hospital mortality rate was 5.1%, and the amputation rate within 30 days was 12.7%. Any-degree malnutrition was detected in 48.3% according to CONUT score (≥2). Any-degree malnutrition was associated with failed thrombolysis and bleeding. The CONUT score predicted insufficient lytic response even after adjustment for confounding factors; however, serum C-reactive protein or neutrophil/lenfosit ratio did not. Other predictors of immediate technical failure after thrombolysis were symptom duration, Rutherford class 4/5 symptoms, and worsened distal runoff. CONCLUSION:In patients with subacute limb ischemia, CDT combined with adjunctive interventions was effective in many patients at the expense of a substantial risk of bleeding and death. Malnutrition was associated with insufficient lytic response and bleeding. Physicians should be aware of malnutrition and consider the nutritional status of patients with limb ischemia when selecting appropriate treatment.
10.5543/tkda.2021.21140
A comparative study of percutaneous atherectomy for femoropopliteal arterial occlusive disease.
Gu Yongquan,Malas Mahmoud B,Qi Lixing,Guo Lianrui,Guo Jianming,Yu Hengxi,Tong Zhu,Gao Xixiang,Zhang Jian,Wang Zhonggao
International angiology : a journal of the International Union of Angiology
BACKGROUND:SilverHawk™ directional atherectomy has been used to treat more than 300 thousand cases of lower extremity atherosclerotic occlusive disease in the world since it was approved by FDA in 2003. This study aimed to analyze the safety and effectiveness of symptomatic femoral popliteal atherosclerotic disease treated by directional atherectomy (DA). METHODS:Clinical data of all consecutive patients treated with percutaneous atherectomy utilizing the SilverHawk™ plaque excision was retrospectively analyzed. The anatomic criteria of the atherosclerotic lesions were divided into four types: type I stenosis; type II occlusion; type III in-stent restenosis; type IV stent occlusion. RESULTS:There were 160 patients treated during the study period. Intermittent claudication in 75 patients (47%), rest pain in 55 patients (34.5%) and tissue loss in 30 patients (18.5%). The number of patients was 72, 15, 49 and 24 in type I, II, III and IV lesions, respectively. Technical success rate was 98.6%, 93.3%, 97.9% and 91.7% in type I, II, III and IV lesions, respectively. Debris of intimal plaque was captured by protection device in 92 patients (71.3%). The mean follow-up period was 23.5±10.4 months. Restenosis rate of type I to IV lesions was 21%, 36%, 36% and 40% respectively. Restenosis rate in type I lesion was significantly lower than that in type III and IV lesions (P<0.05). Patients with tissue loss responded to revascularization as follow: type I, 11/13 healed or reduced (84.6%), type II, 3/3 patients improved (100%), type III, 5/6 patients improved (83.3%) and type IV 4/4 healed (100%). In type IV group, four patients had in-stent thrombosis found by postoperative Duplex ultrasonography. They all underwent DA after catheter-directed thrombolysis with good angiographic results. CONCLUSIONS:Percutaneous DA is safe and effective for both de-novo atherosclerotic and in-stent stenotic or occlusive lesions. Thrombolysis before plaque excision is recommended in case of in-stenting thrombosis.
10.23736/S0392-9590.17.03797-X
Treatment of subacute and chronic thrombotic occlusions of lower extremity peripheral arteries with the excimer laser: a feasibility study.
Shammas Nicolas W,Weissman Neil J,Coiner Denise,Shammas Gail A,Dippel Eric,Jerin Michael
Cardiovascular revascularization medicine : including molecular interventions
BACKGROUND:Thrombus is highly prevalent in patients with recent symptoms (< 6 months) of claudication or limb ischemia due to an occluded culprit lower extremity vessels. Treatment of these thrombotic occlusions is challenging. In this feasibility study, the excimer laser (Spectranetics, Colorado Springs, CO) has been tested for its safety and ability to ablate thrombus in patients with recent arterial occlusions. METHODS:Angiographic operator assessment and volumetric core lab quantitation of the thrombus were performed at baseline and after excimer laser but prior to definitive treatment of the vessel to evaluate thrombus resolution. Consecutive patients were prospectively enrolled at a single site. Procedural success was defined as achieving a residual stenosis of <30% after final treatment with no intraprocedural complications requiring additional treatment. RESULTS:20 consecutive patients were enrolled in this study (8 males, mean age 69.5±11.1 years). Based on patients symptom onset, 12 patients were subacute (> 24 h, < 30 days), and 8 chronic (between 1 to 6 months). 15/20 (75%) had restenotic occlusions. Due to the long, occlusive nature of these lesions, only 8 patients had complete intravascular ultrasound images at each time point which allowed volumetric analysis by the core lab. There was no statistical difference in plaque/thrombus volume between baseline (pretreatment) and excimer laser (P=.68). There was however a significant reduction in residual angiographic stenosis post laser alone (100% vs. 66.75%±23.9%, P=.001). Procedural success was 100%. There were no deaths or amputations. Bail out stenting was performed in 10/20 (50%) patients. Embolic filters were used in 15/20 (75%) of patients. Macrodebris>2 mm were seen in 85.7% of filters. There was no in-hospital or 30-day reocclusion of the treated vessel but one patient had a vascular access complication (small AV fistula) conservatively managed. No other serious adverse events were noted. CONCLUSION:Using the excimer laser appears safe in this small feasibility study of subacute and chronic thrombotic occlusions. Angiographically, there was a significant reduction in percent stenosis with the laser alone. The limited IVUS data did not show a reduction in plaque/thrombus volume but the number of interpretable ultrasounds was small. Further data are needed to address the effectiveness of the laser in treating these thrombotic occlusions and its advantages over balloon angioplasty.
10.1016/j.carrev.2012.05.004
[Debulking strategy of endovascular treatment for lower extremity artery lesions].
Jiang X L,Ju S,Chen B,Jiang J H,Shi Y,Ma T,Lin C P,Guo D Q,Xu X,Dong Z H,Fu W G
Zhonghua wai ke za zhi [Chinese journal of surgery]
To explore the debulking strategy of lower extremity artery lesions. Retrospectively analyzed the clinical data of 101 patients underwent debulking therapy at Department of Vascular Surgery,Zhongshan Hospital,Fudan University from June 2019 to June 2020.There were 74 males and 27 females,aged (73.2±11.7)years (range:35 to 93 years).There were 31 cases in Rutherford class 3,39 cases in class 4 and 31 cases in class 5. Hypertension occurred in 72 patients. One hundred and forty lesions were treated in 101 patients. Among them, there were 13 lesions(9.3%) in iliac artery,72 lesions(51.4%) in superficial femoral artery,41 (29.3%) lesions in popliteal artery,10 lesions(7.1%) in tibiofibular trunk,and 4 lesions(2.9%) in below the knee artery.Percutaneous mechanical thrombectomy (PMT) was mainly used in acute thrombosis,excimer laser ablation (ELA) was mainly used for chronic in-stent restenosis and chronic stenosis or totally occlusive lesions,while directional atherectomy (DA) was mainly used for short calcified lesions. All of the patients underwent debulking therapy. Eighty-two lesions(58.6%,82/140) were treated by PMT, 56 (40.0%,56/140) were treated by ELA,and 2 (1.4%,2/140) were treated by DA.The ankle-brachial index of the patient was 0.44±0.19 before surgery, 0.87±0.17 immediately after surgery (=-16.26, <0.01), and 0.81±0.20 at 6 months after surgery(=-14.67,<0.01),and 0.79±0.15 (=-14.12,<0.01) at 12 months after surgery. At 12 months,the primary patency was 86.1% (87/101),mortality was 5.0% (5/101), freedom from major-amputation survival rate was 93.1% (94/101),and target lesion reintervention rate was 9.9% (10/101). Debulking is feasible and effective to eliminate the arterial contents and maximize the acquisition of lumen.Selection of suitable debulking methods for different segments and lesions would be helpful to improve the technical success and obtain satisfactory results.
10.3760/cma.j.cn112139-20210901-00412
Catheter-directed thrombolysis is not limited to acute limb ischemia treatment: experience from a division of vascular surgery.
Lukasiewicz Aleksander,Flisinski Piotr,Lichota Wojciech
The Journal of cardiovascular surgery
BACKGROUND:Thrombolytic treatment has many potential indications in the era of modern vascular surgery. We aimed to analyze the contemporary experience in the catheter-directed, intraarterial thrombolysis in different clinical scenarios. METHODS:The available data of 121 patients with different types (acute, subacute, complications of vascular procedures) of lower limb ischemia treated by means of the intraarterial, catheter-directed thrombolysis between November 2011 and December 2016 were retrospectively analyzed. The basic treatment protocol, utilized in 92% of patients, was a catheter-directed infusion of 40 mg of alteplase within 3.5 hours. Pre- and intraprocedural factors (indications, demographic details, comorbidities, the dose of alteplase utilized, underlying lesions procedures), as well as postoperative outcomes (lysis grade, death, complications, reinterventions, and limb loss after 1-month observation), were analyzed. RESULTS:Successful thrombolysis was achieved in 76.1% (92 of 121) patients. The success rate was similar for acute, subacute limb ischemia and thrombotic complications of vascular procedures. Around 67.8% of patients (N.=82) had procedures to correct underlying lesions performed. Overall complication rate was 28.1%, but the major bleeding was observed in only 5% (6 patients). Neither intracranial bleeding nor gastrointestinal bleeding occurred. No mortality, 1.7% reintervention rate and 10.7% amputation rate were recorded during one-month follow-up. CONCLUSIONS:Accelerated intraarterial thrombolysis is an effective measure in the treatment of acute, sub-acute limb ischemia as well as thromboembolic complications of vascular procedures. It carries a low risk of major bleeding. The location of thrombus in the crural arteries adversely affects the treatment results. Atrial fibrillation increases the risk of amputation while complete thrombus lysis is protective.
10.23736/S0021-9509.17.10023-6
Prospective Single-Arm Trial of Endovascular Mechanical Debulking as Initial Therapy in Patients With Acute and Subacute Lower Limb Ischemia: One-Year Outcomes.
Bulvas Miroslav,Sommerová Zuzana,Vaněk Ivan,Weiss Jiří
Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists
PURPOSE:To report the results of a prospective, single-arm study to establish whether the initial treatment of acute or subacute limb ischemia (ALI and SLI, respectively) can be accomplished successfully using endovascular mechanical debulking of the target vessels to avoid the risks associated with thrombolysis and/or open surgery. MATERIALS AND METHODS:From April 2009 to April 2015, 316 consecutive patients (mean age 70.9±12 years; 184 men) with ALI (202, 63.9%) or SLI (114, 36.1%) were enrolled; the only exclusion criterion was irreversible ischemia. The ALI group included 146 (72.3%) participants with category IIb ischemia and 56 (27.7%) with category IIa. Critical limb ischemia was diagnosed in 74 (64.9%) of the 114 patients with SLI. Target occlusions of thrombotic (n=256) or embolic (n=60) origin were located in the femoropopliteal segment (n=231), prosthetic or venous femoropopliteal bypass grafts (n=75), and the aortoiliac segment (n=35). The mean occlusion length was 22.9±14.8 cm. RESULTS:The overall technical success (residual stenosis ≤30%) was 100% after debulking and adjunctive techniques (aspiration, dilation, stenting) at the level of the target lesions. No open surgical or thrombolytic modalities were necessary to bypass or recanalize the target vessels, and no death occurred in association with target occlusion therapy. Additional infrapopliteal interventions were performed in 195 (61.7%) patients (adjunctive thrombolysis in 29) to treat acute, subacute, and chronic lesions. Minor complications directly related to the debulking procedure occurred in 26 (8.2%) patients. Serious complications occurred in 11 (3.5%) patients, including hemorrhage in 8 (2.5%) patients (associated with infrapopliteal thrombolysis in 5). At 30 days, primary and secondary patency rates were 94.3% and 97.2%, respectively; mortality was 0.3% (1 fatal intracranial hemorrhage after adjunctive thrombolysis). Of 229 patients eligible for 1-year follow-up, amputation-free survival was estimated to be 87.4% in 199 patients with available data. CONCLUSION:In this all-comers study, mechanical debulking with the Rotarex alone or with adjunctive techniques is feasible as a primary therapy for occluded supratibial vessels in patients with ALI or SLI.
10.1177/1526602819840697
Long-term outcomes of low-dose catheter-directed thrombolytic therapy: a 5-year single-center experience.
Sebastian Arun J,Robinson Graham J,Dyet John F,Ettles Duncan F
Journal of vascular and interventional radiology : JVIR
PURPOSE:To determine immediate and long-term outcomes following catheter-directed intraarterial thrombolysis of occluded native arteries and infrainguinal vein grafts by using low-dose tissue-type plasminogen activator (tPA) in patients with lower limb ischemia. MATERIALS AND METHODS:One hundred eleven intraarterial thrombolysis procedures were performed in 96 patients during the 2-year study period. Patient records were available for retrospective review in 85 thrombolytic procedures performed in 74 (77%) of the 96 patients. Forty-one native vessels (four iliac, 24 superficial/common femoral, and 13 popliteal/below-knee vessels), six iliac stents, and 38 infrainguinal vein grafts were treated by using a low-dose (0.5 mg/h recombinant tPA) catheter-directed thrombolytic regimen. Procedural success was based on angiographic and clinical outcomes, and the need for further reconstructive surgery or amputation was documented. RESULTS:Intraarterial thrombolysis was successful in 76%, was partially successful in 11%, and failed in 13%. Adjunctive angioplasty was performed in 33 of 55 patients (60%) with successful lysis, and immediate reconstructive surgery was required in five patients. There was one episode of puncture site bleeding and one gastrointestinal hemorrhage but no procedure-related deaths at 30 days. After a median follow-up of 6.5 years, 30 of the 55 patients (55%) who underwent successful thrombolysis required no further surgical intervention; however, further surgery was required in 45% of patients after a mean interval of 301 days (range, 2-1,344 days), including 10 (18%) amputations (six major and four minor). CONCLUSIONS:Low-dose intraarterial thrombolysis is safe and effective, delaying and dramatically reducing the need for surgical intervention in lower limb ischemia due to native vessel or infrainguinal graft occlusion.
10.1016/j.jvir.2010.03.018
Safety and efficacy of mechanical aspiration thrombectomy for patients with acute lower extremity ischemia.
Journal of vascular surgery
OBJECTIVE:Acute limb ischemia (ALI) is associated with high rates of amputation and consequent morbidity and mortality. The objective of this study is to report on the safety and efficacy of aspiration thrombectomy using the Indigo Aspiration System in patients with lower extremity (LE) ALI. METHODS:The STRIDE study was an international, multicenter, prospective, study that enrolled 119 participants presenting with LE-ALI. Patients were treated firstline with mechanical thrombectomy using the Indigo Aspiration System, before stenting or angioplasty, or other therapies as determined by treating physician. The primary end point was target limb salvage at 30 days after the procedure. Secondary end points within 30 days included technical success, defined as core laboratory-adjudicated Thrombolysis in Myocardial Infarction (TIMI) 2/3 flow rate immediately after the procedure, changes in modified Society for Vascular Surgery runoff score, improvement of Rutherford classification compared with before the procedure, patency, rate of device-related serious adverse events, and major periprocedural bleeding. Secondary end points that will be evaluated at 12 months include target limb salvage and mortality. RESULTS:Of the 119 participants enrolled at 16 sites, the mean age was 66.3 years (46.2% female). At baseline (n = 119), ischemic severity was classified as Rutherford I in 10.9%, Rutherford IIa in 54.6%, and Rutherford IIb in 34.5%. The mean target thrombus length was 125.7 ± 124.7 mm. Before the procedure, 93.0% (of patients 107/115) had no flow (TIMI 0) through the target lesion. The target limb salvage rate at 30 days was 98.2% (109/111). The rate of periprocedural major bleed was 4.2% (5/119) and device-related serious adverse events was 0.8% (1/119). Restoration of flow (TIMI 2/3) was achieved in 96.3% of patients (105/109) immediately after the procedure. The median improvement in the modified Society for Vascular Surgery runoff score (before vs after the procedure) was 6.0 (interquartile range, 0.0-11.0). Rutherford classifications also improved after discharge in 86.5% of patients (83/96), as compared with preprocedural scores. Patency at 30 days was achieved in 89.4% of patients (101/113). CONCLUSIONS:In the STRIDE (A Study of Patients with Lower Extremity Acute Limb Ischemia to Remove Thrombus with the Indigo Aspiration System) study, aspiration thrombectomy with the Indigo System provided a safe and effective endovascular treatment for patients with LE-ALI, resulting in a high rate (98.2%) of successful limb salvage at 30 days, with few periprocedural complications.
10.1016/j.jvs.2023.10.062
The effectiveness of percutaneous mechanical thrombectomy in the treatment of acute thromboembolic occlusions of lower extremity.
Liu Liguo,Zhang Xiujun,Huang Mei,Li Junhai,Zhao Ziyuan,Huang Junjie
Vascular
OBJECTIVES:The objective of this study was to evaluate the effectiveness of percutaneous mechanical thrombectomy as the initial thrombus removal method in the treatment of acute lower extremity ischemia. METHODS:The patients with acute lower limb ischemia who underwent percutaneous mechanical thrombectomy between August 2016 and February 2018 were retrospectively reviewed. The patients were diagnosed by clinical examination and computed tomography angiography. The percutaneous mechanical thrombectomy was performed as the initial thrombus removal method, followed by anticoagulation therapy. The patients were followed up by clinical examination, imaging, and ankle brachial index (ABI) examination. RESULTS:Thirty-two patients (21 males, 11 females; average age of 68.53 ± 8.05; three cases of grade III, 29 cases of grade IIB) were reviewed. Recanalization of the thromboembolic occlusions were achieved in all patients. ABI significantly ( < 0.01) increased postoperatively (preoperative ABI: 0.51 ± 0.13; postoperative ABI: 0.85 ± 0.65, ABI at three months postoperatively: 0.84 ± 0.66). Eleven patients underwent balloon dilation and three patients had stent placement. Complete thrombus removal was achieved in all patients. The primary patency at 3 months, 6 months, and 12 months postoperatively was 90%, 85%, and 56%, respectively. The secondary patency at 3 months, 6 months, and 12 months postoperatively was 93%, 87%, and 65%, respectively. CONCLUSIONS:The immediate result appeared to be effective to use percutaneous mechanical thrombectomy as the first thrombus removal method in the treatment of acute thromboembolic occlusions in the lower extremity, while the midterm result needs to be further improved.
10.1177/1708538120981226
Aspiration Thrombectomy with the Indigo System for Acute Lower Limb Ischemia: Preliminary experience and analysis of parameters affecting the outcome.
Rossi Michele,Tipaldi Marcello Andrea,Tagliaferro Francesco Bruno,Pisano Andrea,Ronconi Edoardo,Lucertini Elena,Daffina Julia,Caruso Damiano,Laghi Andrea,Laurino Florindo
Annals of vascular surgery
BACKGROUND:The purpose of our study is to assess the short-term technical success and the safety of the Indigo System in a series of patients undergoing vacuum-assisted catheter direct thrombus aspiration (IS-CDTA) for acute lower limb ischemia (ALLI) and to evaluate which parameters may affect the outcome. METHODS:All procedures using the IS-CDTA for ALLI, performed in a single-centre Interventional Radiology Unit from February 2016 to March 2020, were retrospectively analysed. Technical success was defined as the achievement of nearly-complete or complete revascularization (TIPI grade 2/3) and considered as a good outcome. Variables potentially correlated with the IS-CDTA outcome were analysed. RESULTS:33 procedures were performed in 29 patients. Mean age was 69 years old (range 47 - 88), 24 males (83%) and 5 females (18%). The technical success was 70%. Catheter-directed thrombolysis following IS-CDTA was performed in 23 cases and the overall technical success increased from 70% to 90%, afterwards. The median time between symptoms insurgency and IS-CDTA was significantly shorter in patients with good outcome (10 hours; IQR 2.75-48) compared to those with poor outcome (168 hours; IQR 36-336) (P = 0.003). No statistically significant differences were found between the two groups regarding ATK vs. BTK (P = 0.34), native vessel vs. graft (P = 0.25), occlusion nature P = 0.28) or Rutherford score (P = 0.80). CONCLUSION:IS-CDTA is a valid option for a rapid and percutaneous treatment of ALLI. Our experience indicates that the time elapsing from the symptoms insurgency and the endovascular procedure is the best positive predictor of the outcome.
10.1016/j.avsg.2021.04.016
The "DEBELLUM"--lower limb multilevel treatment with drug eluting balloon--randomized trial: 1-year results.
Fanelli F,Cannavale A,Corona M,Lucatelli P,Wlderk A,Salvatori F M
The Journal of cardiovascular surgery
AIM:The aim of the present paper was to make a report of the 12-month clinical outcomes of the DEBELLUM (Drug-Eluting-Balloon-Evaluation-for-Lower-Limb- mUltilevel-treatMent) randomized trial. METHODS:From September 2010 to March 2011, 50 patients were randomized between drug eluting balloon (DEB, N.=25) and conventional angioplasty balloon (PTA, N.=25). Patients were symptomatic for claudication and critical limb ischemia, with de novo stenosis or occlusion in the femoropopliteal (SFA) and infrapopliteal (BTK) region. Only in the SFA primary stenting was allowed and postdilatation performed with DEB or PTA depending on the assigned group. RESULTS:One hundred and twenty-two lesions were treated: 92 (75.4%) SFA, 30 (24.6%) BTK. Twenty (40%) patients presented multilevel concomitant femoropopliteal and infra-popliteal lesions. Late lumen loss (LLL) was 0.64±0.9 mm in DEB group vs. 1.81±0.1 mm in the control group (P=0.01). In non-stented segment LLL was 0.63±0.9 mm (DEB) vs. 1.70±0.6 mm (PTA), P<0.01. In the stent subgroup was LLL 0.65±0.2 mm (DEB) vs. 1.91±0.3 mm (PTA), P<0.01. In the femoropopliteal region the overall LLL was 0.61±0.8 mm for DEB vs. 1.84±0.3 mm for PTA (P=0.02). BTK the overall LLL was 0.66±0.9 mm (DEB) vs. 1.69±0.5 mm (PTA) (P=0.03). The overall TLR was 12.2% for DEB and 35.3% for PTA (P<0.05). Amputation rate was 4% (DEB) vs. 12% (PTA), P=0.36. Thrombosis was 4% (DEB) vs. 8% (PTA), P≥0.05. Major adverse events 24% (DEB) vs. 60% (PTA), P<0.05. ABI improved more in the DEB group: 0.81±0.3 vs. 0.68±0.13 (P=0.02). Fontaine stage increased (from II b to I) 80% DEB vs. 56% PTA (P<0.05). CONCLUSION:Results confirm and reinforce initial 6-month outcomes. In.Pact DEB balloons can be considered efficient to reduce restenosis rate.
Thrombectomy Using Myocardial Biopsy Forceps in Acute Limb Ischemia Patients.
Shimada Takenobu,Urasawa Kazushi,Haraguchi Takuya,Kitani Shunsuke,Tan Michinao,Koshida Ryoji,Igarashi Yasumi,Sato Katsuhiko
Journal of vascular and interventional radiology : JVIR
PURPOSE:To evaluate the efficacy and safety of thrombectomy using myocardial biopsy forceps for the treatment of acute limb ischemia (ALI). MATERIALS AND METHODS:A retrospective review of 11 ALI patients (12 affected limbs, 18 affected vessels) who underwent thrombectomy using biopsy forceps between November 2011 and April 2016 was performed. Of the 12 affected limbs, 2 limbs had stent thrombosis, 1 limb had thrombotic occlusion at a de novo stenosis site, and 9 limbs had embolic ALI. Biopsy forceps were used for angiographically limited arterial flow that persisted after the use of an aspiration catheter and conventional balloon angioplasty. The general technique for use of the biopsy forceps included advancement in parallel to a guidewire to the thrombus site, grasping of the thrombus with the forceps, and confirmation of grasping the thrombus with injection of a contrast medium prior to thrombus extraction. RESULTS:Partial or total retrieval of the thrombus was angiographically confirmed in 12 of the 18 affected vessels, with restoration of normal blood flow in 11 vessels. Unsuccessful results in the remaining 6 affected vessels appeared to be due to friction at the aortoiliac bifurcation caused by the contralateral approach, small vessel size, or curvature of the anterior tibial artery. None of the 18 treated vessels had any complications such as dissection or perforation of the target vessel wall and distal emboli. None of the surviving patients required major or minor amputation. CONCLUSIONS:Thrombectomy using biopsy forceps is a feasible technique for removal of an arterial thrombus in patients with ALI.
10.1016/j.jvir.2018.02.021
Long-term Outcome after Thrombolysis for Acute Lower Limb Ischaemia.
Grip O,Wanhainen A,Acosta S,Björck M
European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery
OBJECTIVES:The purpose was to study long-term outcome after thrombolysis for acute arterial lower limb ischaemia, and to evaluate the results depending on the underlying aetiology of arterial occlusion. METHODS:This was a retrospective study of patients entered into a prospective database. Patients were identified in prospective databases from two vascular centres, including a large number of variables. Case records were analysed retrospectively. Through cross linkage with the Population Registry 100% accurate survival data were obtained. Between January 2001 and December 2013, 689 procedures were included. The aetiology of ischaemia was graft/stent/stent graft occlusion in 39.8%, arterial thrombosis in 27.7%, embolus in 25.1% and popliteal aneurysm in 7.4%. RESULTS:The mean follow-up was 59.4 months (95% CI, 56.1-62.7), during which 32.9% needed further re-interventions, 16.4% underwent amputation without re-intervention, and 50.7% had no re-intervention. The need for re-intervention during follow-up was 48.0% in the graft/stent occlusions group, 34.0% of the popliteal aneurysm group, 25.4% in the thrombosis group, and 16.3% in the embolus group (p < .001). The overall primary patency rates were 69.1% and 55.9% at 1 and 5 years, respectively. Primary patency at 5 years was higher for the embolus group (83.3%, p = .002) and lower for the occluded graft/stent group (43.3%, p < .001). Secondary patency rates were 80.1% and 75.2% at 1 and 5 years, respectively, without difference between the subgroups. The amputation rate was lower in the embolic group at 1 and 5 years (8.1% and 11.1%, respectively, p = .001). Survival was higher in the group with occluded popliteal aneurysms at 5 years (83.3%, p = 0.004). Amputation free survival was 72.1% and 45.2% at 1 and 5 years; lower in the occluded graft/stent group at five years (37.9%, p = .007). CONCLUSION:Intra-arterial thrombolytic therapy achieves good medium and long-term clinical outcome, reducing the need of open surgical treatment in most patients.
10.1016/j.ejvs.2017.02.003
Fast-track thrombolysis protocol for acute limb ischemia.
Ascher Enrico,Kibrik Pavel,Rizvi Syed Ali,Alsheekh Ahmad,Marks Natalie,Hingorani Anil
Journal of vascular surgery
OBJECTIVE:Catheter-directed thrombolysis in the treatment of acute lower extremity arterial occlusions often requires several interventional sessions to generate successful outcomes. It is typically an expensive procedure, necessitating extended hospital length of stay (LOS) that may be associated with an increase in both local and systemic hemorrhagic complications. Five years ago, we created the fast-track thrombolysis protocol for arteries (FTTP-A) to deal with these concerns. The goal of our protocol is to re-establish patency during the first session of thrombolysis, thus decreasing costs and complications associated with prolonged periods of thrombolytic exposure. METHODS:A retrospective study of 42 patients who were treated for acute limb ischemia at our institution by FTTP-A from January 2014 to February 2019 was performed. FTTP-A includes periadventitial lidocaine injection at the arterial puncture site under ultrasound guidance, contrast arteriography of the entire targeted segment, pharmacomechanical rheolytic thrombectomy of the occluded arterial segment, tissue plasminogen activator infusion along the occluded segment, balloon maceration of the thrombus, and (if deemed necessary) placement of a stent in an area of significant (≥30%) stenosis that is refractory to balloon angioplasty and thrombolysis. After the stenosis or thrombus is cleared, patients are prescribed an oral anticoagulant agent. RESULTS:Primary FTTP-A (50 total interventions) was performed in 42 patients. The median age of patients was 67.2 ± 12.2 years (range, 41-98 years), and 54.8% were male; 59.5% of the procedures were performed on the left lower extremity. Initial arterial access was obtained through the common femoral artery in 39 of 42 cases (92.9%); in the remaining 3 cases, it was obtained in a left bypass access site, a right femoral-popliteal graft, and a right femoral-femoral graft. The mean operative time was 148.9 ± 62.9 minutes (range, 83-313 minutes), and the mean volume of tissue plasminogen activator infused was 9.7 ± 4.0 mg (range, 2-20 mg). The median cost including medications and interventional tools was $4673.19 per procedure. The mean postoperative LOS was 3.1 ± 4.5 days (range, 1-25 days). Median postoperative LOS was 1 day. Mean postoperative follow-up was 27 ± 19.2 months (range, 0-62 months). Single-session FTTP-A was successful in 81% (n = 34/42) of patients; the remaining 8 patients (19%) required a single additional session. Of the 42 patients, 34 (81%) required arterial stenting. Periprocedural complications consisted of one patient with hematuria, which resolved, and one patient with thrombocytopenia, which resolved. No patients experienced rethrombosis within 30 days of FTTP-A. During the 5-year study period, there was no significant local or systemic hemorrhage, limb loss, or mortality related to this protocol. CONCLUSIONS:FTTP-A appears to be a safe, efficacious, and cost-effective procedure in the resolution of acute lower extremity arterial occlusions.
10.1016/j.jvs.2020.03.061
[Application of mechanical debulking in arteriosclerosis occlusive disease of lower extremity].
Zhonghua wai ke za zhi [Chinese journal of surgery]
To evaluate the effect of mechanical debulking in treating arteriosclerosis occlusive disease of lower extremity. The clinical data of 52 arteriosclerosis occlusive disease of lower extremity cases treated with Rotarex mechanical debulking system from June 2017 to June 2020 at Department of Intervention Vascular Surgery,Peking University Third Hospital were retrospectively analyzed. There were 37 males and 15 females,aged(69.4±10.1)years(range:47 to 89 years).Lesion length was (21.6±12.9)cm(range:4 to 45 cm),occlusion length was (18.5±11.8)cm(range:4 to 45 cm).The lesion was located in iliac artery(IA) in 6 cases,femoral-popliteal artery(FPA) in 42 cases,and both IA and FPA in 4 cases. All the cases were treated with Rotarex mechanical debulking system. Residual stenosis more than 50% were treated with percutaneous transluminal angioplasty(PTA).Drug coated balloon was used in part of them,and stent was used only when it was necessary. The patient's operation, complications, postoperative target vessel restenosis and reoperation were collected. The paired sample test and rank sum test was used for data comparison and the postoperative target vessel patency rate was analyzed by Kaplan-Meier survival curve. All the 52 cases obtained technical success. Percutaneous transluminal angioplasty was used in all cases,and drug coated balloon were used in 11 cases. Twenty-six stents were implanted in 24 cases (2 cases implanted 2 stents).Nine stents were implanted in IA and 15 in FPA. The length of stents was (11.3±3.3)cm(range:6 to 23 cm).There were 3 procedure related complications: one of them was acute occlusion in an iliac lesion,and thrombectomy was applied urgently,and the result was good. And the other two were distal embolism. The thrombus were took out with guiding catheter. The hospital stay was (4.8±1.9)days. The ankle brachial index increased from 0.34±0.16 to 0.81±0.16 after treatment(=-25.160,<0.01).The Rutherford stages decreased from ((IQR)) 3(1) to 1(1(=-6.825,<0.01).The median followed up time was 19 months(range:6 to 42 months).Two cases stopped antiplatelet agents during follow-up and which result in acute thrombosis 2 weeks and 2 months later respectively. One of them was treated with percutaneous mechanical thrombectomy and the other one was not for gastrointestinal hemorrhage. Four cases died during follow-up,one case died of lung cancer,one died of abdominal infection,and the other 2 cases died of cardiovascular disease,and no amputation was observed. Target lesion restenosis(TLR) more than 50% occurred in 13 cases during the follow-up. All TLR were observed in FPA,and target lesion revascularization was taken in 3 of them. According to Kaplan-Meier survival curve analysis,half-year,1-year and 2-year cumulative patency rates of target vessels in this group was 94.2%,87.4% and 51.4%, respectively. And half-year and 1-year cumulative patency rates just in FPA cases was 92.9% and 84.3%, respectively. Percutaneous mechanical debulking using Rotarex catheter combining PTA can reduce the use of stents in femoral-popliteal artery. It is safe and effective in treating with arteriosclerosis obliterans of lower extremity.
10.3760/cma.j.cn112139-20211022-00498
Catheter-directed intra-arterial thrombolysis for lower extremity arterial occlusions.
Güneş Yılmaz,Sincer Isa,Erdal Emrah
Anatolian journal of cardiology
Catheter-directed intra-arterial thrombolysis (CDT) is a rational treatment method in patients with acute/subacute and even some chronic occlusions of lower extremity arteries and bypass grafts having salvageable limb ischemia. Immediate vessel patency can be achieved with an acceptable complication rate in many patients, especially those with fresh thrombus or emboli. It can be also an adjuvant treatment modality for endovascular interventions for chronic occlusions. There is no standard method of CDT including thrombolytic agent dose and technique. Selection of treatment strategy should be based on individual judgment based on viability of limb, lesion characteristics, and risks of hemorrhage.
10.14744/AnatolJCardiol.2019.63296