Treatment Of Acute Lower Limb Ischemia Research Articles

Mechanical thrombectomy in acute limb ischemia: ad Interim results of the INDIAN UP Trial.

Penumbra/Indigo aspiration thrombectomy Systems (Penumbra Inc.) in patients with acute lower limb ischemia (ALLI) is becoming a fundamental alternative to surgical and intra-arterial thrombolysis. The INDIAN UP trial represents the second phase of the Italian national multicenter trial evaluating the safety and effectiveness of the device in the treatment of ALLI. To assess vessel patency, the TIPI (Thrombo-aspiration In Peripheral Ischemia), is used. The TIPI flow in three different moments: at presentation, immediately after thromboaspiration, and after all adjuvant procedures. The primary outcome is the technical success of the thrombo-aspiration with the investigative system, defined as near complete or complete revascularization TIPI 2 - 3. Safety and clinical success rate were collected at one month follow-up. A total of 250 patients were enrolled. The mean age was 72.2±13.1 years and 72.1% were male. Rutherford grade on enrolment was I in 10.8%, IIa in 34.9%, and IIb in 54.4%. Primary technical success (TIPI 2-3 flow) was achieved in 90.8% of patients. Adjunctive procedures were needed in 158 cases. After all interventions, assisted primary technical success was 96.4%. No systemic bleeding complications or device related serious adverse events were reported. At one month follow up, survival rate was 97.2%, limb salvage was 97.6%. Primary patency was 89.6% and 13 (5.4%) reinterventions were registered. The updated results of the INDIAN UP trial have confirmed the high value of the mechanical thromboaspiration device Indigo Penumbra in the treatment of ALLI in a large variety of clinical and anatomical settings.

Retracted: Solitaire™ Stent Thrombectomy System in the Treatment of Acute Lower-Limb Ischemia: Comparisons in Safety and Effectiveness with Conventional Catheter-Directed Thrombolysis Therapy.

[This retracts the article DOI: 10.1155/2022/6997221.].

Solitaire™ Stent Thrombectomy System in the Treatment of Acute Lower-Limb Ischemia: Comparisons in Safety and Effectiveness with Conventional Catheter-Directed Thrombolysis Therapy.

Objective The study aimed to investigate the safety and efficacy of the Solitaire™ AB Stent System (ev3 Inc., Plymouth, MN, USA) for the treatment of acute lower extremity ischemia (ALLI) compared with conventional catheter-directed thrombolytic therapy. Methods Retrospective analysis of patients with ALLI treated in the Department of Interventional Radiology at the First Hospital of Nanjing from January 2017 to April 2020 divided into a conventional (CDT) group (n = 106) and a percutaneous mechanical thrombectomy (PMT) group (n = 55) according to the procedure. PMT was performed using the Solitaire™ AB stent system. The combined clinical outcomes of mortality, major amputation, recurrent ischemia, and major morbidity were compared between the two groups. Results Of the 161 patients, 128 (79.5%) did not have a composite clinical outcome after 12 months of follow-up, namely, 78 CDT patients and 50 PMT patients, with significant differences in composite clinical outcome (26.4% vs. 9.1%, P = 0.010) and mortality (19.8% vs. 7.3%, P = 0.037) between them. Thrombolytic drug dose (19.34 ± 5.93 vs. 13.55 ± 6.54 mg, P < 0.001) and length of hospital stay (8.29 ± 3.91 vs. 5.49 ± 1.18 days, P = 0.003) were significantly lower in the PMT group. Conclusion PMT with the Solitaire™ AB Stent System is safer and more effective in treating patients with Rutherford stage I-IIB ALLI, with the advantage of rapid opening of obstructed vessels, shorter thrombolysis time, reduced thrombolytic dose, and improved blood flow to the infrapopliteal vessels.

Acute Compartment Syndrome Following Thrombolysis For Acute Lower Limb Ischemia

Acute Compartment syndrome (ACS) with subsequent need for fasciotomy is a serious and insidious complication after revascularization for acute lower limb ischemia (ALI). The development of ACS during endovascular catheter directed thrombolysis is particularly difficult to identify. The aim was to identify the incidence, predisposing factors, wound treatment, and outcome in terms of amputation and survival for patients presenting with ALI that develop ACS during catheter directed thrombolysis. Patients who did not develop ACS after thrombolysis were analyzed as controls. Descriptive retrospective analysis of prospective databases from two large tertiary-referral vascular centers. Patients with ACS after thrombolysis for ALI between 2001-2017 were analyzed. Seventy-eight cases and 621 controls were identified. Mean age was 72 years and 30 (38.5%) were women in the ACS group. Patients that developed ACS presented with significantly more severe preoperative ischemia. With 38.5% having Rutherford 2b classification as compared to 22.7 % in the control group (P=0.002). Occluded popliteal artery aneurysms were also associated with a higher incidence of ACS (P=0.041). Treatment of the fasciotomy wound was most commonly treated with regular wound dressing in 45 (58%) of cases, while wound dressing and foot pump and vacuum assisted closure were used in 14 (18%) and 19 (24%) respectively. These differing approaches did not affect the number of wound infections and amputations, which was similar regardless of treatment type. Vacuum assisted closure was associated with a higher degree of skin graft closure (P=0.001). The median time to complete wound closure was 10 days. One year after thrombolysis, the major amputation rate in the ACS group was 31% as opposed to 17% in control group, P=0.003. Mortality measured at 16.7% and 15.3%, respectively, P=0.872. Amputation-free survival in the ACS group was 62% vs. 73% in the control group, P=0.035. These differences level out, however, when applying long-term analysis of amputation-free survival in Kaplan-Meier analysis (log-rank 0.103). Patients that developed ACS during endovascular CDT presented with a more severe pre-operative ischemia, more occluded popliteal artery aneurysms and had a higher amputation rate during the first year, compared to controls. The development of ACS during endovascular treatment of ALI with thrombolysis is not uncommon and warrants both clinical awareness and rapid treatment.

The Indigo System in Acute Lower-Limb Malperfusion (INDIAN) Registry: Protocol.

BackgroundAcute lower limb ischemia (ALLI) poses a major threat to limb survival. For many years, surgical thromboembolectomy was the mainstay of treatment. Recent years have brought an endovascular revolution to the management of ALLI. It seems that the newly designed endovascular thrombectomy devices may shift treatment recommendations toward endovascular options. This protocol study aims to collect evidence supporting the latest hypothesis.ObjectiveThe devices under investigation are the Penumbra/Indigo Systems (Penumbra Inc). The objective of this clinical investigation is to evaluate, in a controlled setting, the early safety and effectiveness of the devices and to define the optimal technique for the use of these systems in patients with confirmed peripheral acute occlusions.MethodsThis study will be an interventional prospective trial of patients with a diagnosis of ALLI treated with Penumbra/Indigo devices. This project is intended to be a national platform where every physician invited to participate could register his or her own data procedure. The primary outcome is the technical success of thromboaspiration with the Indigo System. Assessment of vessel patency will be recorded using the Thrombolysis in Myocardial Infarction (TIMI) score classifications before and after use of the device. Clinical success at follow-up is defined as an improvement of Rutherford classification at 1-month follow-up of one class or more as compared to the preprocedure Rutherford classification. Secondary endpoints include the following: (1) safety rate at discharge, defined as the absence of any serious adverse events; (2) primary patency at 1 month, defined as a target lesion without a hemodynamically significant stenosis or reocclusion on duplex ultrasound (>50%) and without target lesion reintervention within 1 month; and (3) limb salvage at 1 month.ResultsThe study is currently in the recruitment phase and the final patient is expected to be treated by the end of March 2019. A total of 150 patients will be recruited. Analyses will focus on primary and secondary endpoints.ConclusionsThese new endovascular thrombectomy devices that are specifically designed for peripheral intervention in this difficult set of patients, as those under investigation in the proposed registry, may offer improved clinical outcomes with lower rates of major systemic and local complications. Following completion of this study, it is expected that the value of the Indigo Thrombectomy System in the treatment of ALLI will be better defined. As a result, a shift of treatment recommendations toward endovascular options may be observed in the near future.International Registered Report Identifier (IRRID)DERR1-10.2196/9972

Acute on chronic limb ischemia: From surgical embolectomy and thrombolysis to endovascular options

After the invention of the balloon catheter by Fogarty in 1963, surgical thromboembolectomy was considered the gold standard treatment for many years in patients with acute lower limb ischemia (ALLI). ALLI is a dramatic event, carrying a high risk of amputation and perioperative morbidity and mortality. The evolution of endovascular technologies has resulted in a variety of therapeutic options to establish arterial patency. In the 1970s, Dotter first introduced the idea of clot lysis in the treatment of ALLI, which was modified to catheter-directed thrombolysis, and now clot aspiration techniques. Currently, the majority of ALLI (about 70%) is arterial thrombosis, which generally occurs in the setting of preexisting vascular lesion. This condition is very common in patients with diabetes. Clinical presentation in case of thrombosis on atherosclerotic stenosis (so called “acute on chronic ischemia”) may be less severe, but treatment is generally more challenging than ALLI due to embolism, considering the complexity in device trackability through the diseased vessels, potential vessel injury, incomplete revascularization, and need of correction of underlying vascular lesions. Although surgery is still a treatment option, especially for ALLI, endovascular interventions have assumed a prominent role in restoring limb perfusion. In this review, the treatment options for ALLI are detailed from surgical thromboembolectomy to thrombolysis and current endovascular techniques, including mechanical fragmentation, rheolytic thrombectomy, and aspiration thrombectomy. The evolution to endovascular therapies has resulted in improved clinical outcomes and lower rates of morbidity.

Aspiration Thrombectomy versus Conventional Catheter-Directed Thrombolysis as First-Line Treatment for Noniatrogenic Acute Lower Limb Ischemia

PurposeTo examine the efficacy, safety, and procedural costs of percutaneous aspiration thrombectomy (PAT) as a first-line treatment for noniatrogenic acute lower limb ischemia (ALI) compared with conventional catheter-directed thrombolysis (CDT). Materials and MethodsAll patients who underwent endovascular intervention for ALI from January 2015 to August 2017 were included. Fifteen patients were treated with the use of primary PAT and 27 patients were treated with the use of primary CDT. The primary end point was complete thrombus clearance with improvement in Thrombolysis in Myocardial Infarction (TIMI) score. Adjunctive treatment for thrombus removal was considered to indicate technical failure. Treatment of underlying chronic disease was not considered to indicate technical failure. Procedural costs for each patient were calculated by itemizing all disposable equipment, facility overheads, and staff costs. ResultsOf the 15 primary PAT patients, technical success was achieved in 8 (53%); the remaining 7 (47%) required adjunctive CDT. Of the 27 primary CDT patients, technical success was achieved in 25 (89%); the remaining 2 (11%) required adjunctive PAT. There were 4 complications in the primary PAT group: 2 were procedure related and of a minor grade. There were 8 complications in the primary CDT group: All were procedure-related, including 2 major groin/retroperitoneal hemorrhage and 1 death from intracranial hemorrhage. Limb salvage was attained in all patients. There were no significant differences in average procedural costs per patient between the 2 groups. ConclusionsFirst-line use of PAT for endovascular treatment of ALI can reduce the need for CDT, with no significant cost difference.

Shredding Embolectomy Thrombectomy Catheter for Treatment of Acute Lower-Limb Ischemia

We undertook a prospective evaluation to prove a new mechanical thrombectomy device, the shredding embolectomy thrombectomy catheter (S.E.T. catheter), for the treatment of patients with acute lower-limb ischemia. The study evaluated the success, patency, mortality, limb salvage, and complication rates for 51 patients treated from January 1994 through June 1996, with this device, which was an 8-F three-lumen catheter. The onset of symptoms was 8.6 +/- 9 days. Thrombus length was 18 +/- 9 cm situated in 44 native vessels and in 7 bypasses, 42 limbs were graded as threatened. Hydromechanical thrombectomy with the S.E.T. catheter proved to be a quick and safe adjunct for therapy of acute femoropopliteal thromboembolic occlusions with a high initial success rate and an acceptable mid-term patency rate.

Treatment of Acute Lower-Limb Ischemia: Roles of Thrombolysis and Surgery

Treatment of Acute Lower-Limb Ischemia: Roles of Thrombolysis and Surgery

Assessment of Peripheral Intraarterial Thrombolysis versus Surgical Revascularization in Acute Lower-Limb Ischemia: A Review of Limb-Salvage and Mortality Statistics

To review the risks and benefits of using peripheral intraarterial thrombolysis (PIAT) versus surgical revascularization (SR) as the initial treatment of acute lower-limb ischemia (ALLI). Two prospective, randomized trials that compared PIAT with SR in the treatment of ALLI were analyzed along with recent large, retrospective studies. Overall, 1,051 SR cases and 895 PIAT cases were included; when possible, the ischemic events were further categorized as acute, chronic, embolic, or thrombotic. Limb salvage and mortality at 30-day and 6-12-month follow-up were assessed. Combined percentages were derived by proportionally weighing each study. When all studies were combined, limb salvage rates were 93% for PIAT and 85.5% for SR at 30 days and 89% versus 73%, respectively, at 6-12-month follow-up. Mortalities were 4% versus 15%, respectively, at 30 days and 8% versus 29%, respectively, at 6-12-month follow-up. PIAT is associated with a substantially better limb-salvage rate and mortality than SR in the treatment of ALLI.