Cleaner XT Rotational Thrombectomy: An Efficacious Endovascular Technique for Salvage of Thrombosed Arteriovenous Access and a 12 Month Outcome Analysis.

PURPOSE: This study aims to describe an efficacious method using Cleaner XT rotational thrombectomy with catheter-directed thrombolysis and drug-eluting balloon angioplasty for the salvage of thrombosed arteriovenous fistulae and grafts. MATERIALS AND METHODS: Retrospective analysis of all patients with thrombosed hemodialysis accesses who underwent endovascular salvage using the Cleaner XT rotational thrombectomy system at a single institution between June 2019 and September 2020 was performed. Patency was presented as Kaplan-Meier survival curves, and regression analysis was performed to examine predictors of postintervention primary patency and assisted primary patency based on Cox proportional-hazards model. RESULTS: Thirty-four patients with thrombosed accesses underwent Cleaner XT rotational thrombectomy between June 2019 and September 2020. Technical and clinical success were both 100%. Mean procedure time was 62 ± 20 minutes. Mean postintervention primary patency time was 152 ± 51 days; 30, 90, 180, and 365 day postintervention primary patency rates were 89%, 80%, 68%, and 56%, respectively. Mean postintervention-assisted primary patency time was 157 ± 59 days; 30, 90, 180, and 365 day postintervention-assisted primary patency rates were 91%, 82%, 71%, and 59%, and 180 and 365 day secondary patency rates were 97.2% and 94.4%, respectively. CONCLUSION: The Cleaner XT rotational thrombectomy device demonstrates excellent clinical and technical success rates, with good patency results at all time points up to 12 months postintervention.

Aspirex S catheter malfunction during arteriovenous fistula thrombectomy secondary to a jammed helix-guidewire complex.

PURPOSE: To report a potential complication when using the Aspirex S rotational thrombectomy catheter. CASE REPORT: A 76-year-old woman with end-stage renal failure presented with left brachiocephalic arteriovenous fistula (BCAVF) dysfunction and subsequently underwent percutaneous thrombectomy using the Aspirex S catheter. During the course of the thrombectomy, device malfunction ultimately resulted in complete thrombosis of the cephalic outflow tract; eventually, a new right BCAVF had to be created. CONCLUSION: There are possible complications when using the Aspirex S catheter in thrombectomy of dialysis accesses, and further experience with this thrombectomy device is needed to fully understand its potential and limitations.

Rotational thrombectomy versus balloon maceration in dialysis access salvage.

BACKGROUND: Although end stage renal disease patients who undergo hemodialysis frequently experience dialysis-associated thrombotic complications, there remains a paucity of literature comparing the efficacy of different endovascular salvage techniques for grafts and fistulas. This study aims to compare primary patency in dialysis access following salvage mechanical thrombolysis/thrombectomy with a rotational thrombolysis device versus balloon maceration. METHODS: Using a database of patient records at a tertiary medical center, all patients who underwent rotational thrombectomy with the Cleaner XT™ Rotational Thrombectomy System for endovascular salvage of arteriovenous fistula or arteriovenous graft from August 2016 to July 2022 were included in the population. Fourteen patients who underwent balloon maceration for endovascular salvage were matched to the patients in the rotational thrombectomy group based on date of procedure. The primary patency of the fistula or graft for the two groups was measured. RESULTS: A total of 13 patients who underwent dialysis access salvage with rotational thrombectomy (10 grafts, 3 fistulas) were matched with 14 patients who underwent balloon maceration for dialysis access salvage (10 grafts, 4 fistulas). Six patients in both groups required additional graft access salvage (46% rotational thrombectomy; 43% balloon maceration). The median time to next dialysis salvage was 51 days for rotational thrombectomy and 43.5 days for balloon maceration (W + 9, critical value 1; compatible with statistically significant difference). CONCLUSION: Endovascular access salvage by rotational thrombectomy may provide longer primary patency compared to salvage by balloon maceration. However, a longer follow-up prospective study of a larger study population is necessary to clarify the safety and efficacy of rotational thrombectomy using the Cleaner XT™ device.

Management of a complex transjugular intrahepatic portosystemic shunt dysfunction with endotipsitis through rotational thrombectomy.

Transjugular intrahepatic portosystemic shunting (TIPS) is an established strategy for the management of complications of portal hypertension. Endoprosthetic infection ("endotipsitis") is a rare but serious and difficult-to-treat complication of TIPS placement. Here we report the occurrence of an infected thrombus complicating TIPS placement in a patient with extra-hepatic portal vein obstruction, recurrent variceal bleeding and portal biliopathy accompanied by recurrent cholangitis. Infected thrombotic material within TIPS could be removed only by employing rotational thrombectomy. This procedure revealed the presence of a biliary fistula which carried pathogens in the systemic circulation. The multiple episodes of sepsis did no longer recur following exclusion of the biliary fistula. This case highlights the possibility to use rotational thrombectomy for the management of complex cases of TIPS dysfunction.

Percutaneous Mechanical Thromboembolectomy in Acute Lower Limb Ischemia.

PURPOSE: To analyze the immediate outcome of percutaneous mechanical thromboembolectomy in acute infrainguinal leg ischemia in a consecutive cohort of patients with acute lower limb ischemia. MATERIAL AND METHOD: We retrospectively analyzed the data of 156 acute infrainguinal ischemic events in 148 patients. Patients presented with acute limb ischemia Rutherford category I in 68 cases (44%), Rutherford category II A in 64 instances (41%) and Rutherford II B in 24 instances (15%). In 62 cases (39.7%), the occlusion site started below the knee joint level, in 94 (60.3%) cases above. As a basic technique, an intervention was started by manual aspiration but if aspiration failed, an additional device was added. Most frequently, a rotational thrombectomy device (Rotarex, Straub Medical, Wangs, Switzerland) was used. An antegrade access to the femoral artery was the preferred access to the limb (154/156). RESULTS: In 145 of 156 incidents, a technical success was achieved (93%). Aspiration was used in 153 cases (98%). Rotational thrombectomy by use of the Rotarex catheter was added in 60 cases (38%). Directional atherectomy was applied in a total of five patients. As main technical complications, a downward embolization occurred (n = 11). There were four surgical groin revisions. Five patients died during the early follow-up with four not related to the intervention. Clinically, 135 patients (86.5%) showed an improvement in their clinical situation. CONCLUSION: Acute lower limb ischemia can be successfully treated by mechanical thromboembolectomy only by combining aspiration embolectomy with rotational thrombectomy in most cases but manual aspiration alone will frequently fail especially above the knee joint level.

Stenting of modified Blalock-Taussig shunt in adult with palliated pulmonary atresia and ventricular septal defect: a case report.

BACKGROUND: Adults with complex congenital heart disease palliated with systemic-to-pulmonary artery shunts have become rare and represent a particularly challenging patient group for the cardiologist. One of the complications and causes of severe clinical deterioration during long-term follow-up are progressive obstruction or total occlusion of the shunt. The risk for surgical intervention is frequently high and catheter intervention may be complicated by complex anatomy and shunt calcification. CASE SUMMARY: We report the case of a 47-year-old man with uncorrected (palliated) pulmonary atresia and ventricular septal defect who presented with progressive cyanosis (oxygen saturation 69%) and decreasing exercise capacity. Computed tomography revealed a totally occluded modified left Blalock-Taussig (BT) shunt and a severely stenosed central shunt (Waterston-Cooley) in a patient with confluent but hypoplastic pulmonary arteries and multiple major aortic pulmonary collaterals. Due to a high operative risk, an interventional, percutaneous approach was preferred to re-do surgery. From a radial access the calcified BT shunt could be crossed with a hydrophilic guidewire. Then, a rotational thrombectomy, balloon dilatation, and bare-metal stenting at the proximal and distal anastomoses were performed. Post-interventionally, peripheral oxygen saturation increased from 69% to 82%. Clopidogrel was administered for 1 month after bare-metal stenting. At 1-year follow-up, the BT shunt was still patent on echocardiography and exercise tolerance markedly improved. DISCUSSION: This case highlights the benefit of percutaneous rotational thrombectomy followed by stenting of chronically occluded systemic-to-pulmonary artery shunts for further palliation in adult patients with complex congenital heart disease not suitable for surgical repair.

Rotarex Mechanical Debulking in Acute and Subacute Arterial Lesions.

INTRODUCTION: Data regarding the effectiveness and safety of percutaneous mechanical thrombectomy (PMT) in contemporary routine care are scarce. MATERIALS AND METHODS: Consecutive patients undergoing PMT of native lower limb acutely/subacutely occluded arteries were included. RESULTS: In all, 525 consecutive patients were available for analysis with a mean age of 66.7 ± 10.7 years. Almost two-third (n = 324; 61.7%) were men with acutely (n = 211; 40.2%) or subacutely (n = 314; 59.8%) occluded lesions presenting mostly in Rutherford-Becker category (RBC): 3 (30.3%) and 4 (47.6%). Mean lesion length was 159 mm (range 22-279 mm), with moderate and severe calcification in 119 (23.3%) lesions. PMT was performed solely in 161(27.2%), PMT + balloon angioplasty in 232 (39.1%), provisional stenting in 169 (28.4%), and thrombolysis in 77 (13.9%) interventions. Procedural technical success rate was 97.7%, with improvement in RBC persisting in 74.1% of patients after 12 ± 2.4 months mean time follow-up. Overall 30 days major adverse events (MAEs) was 6.9% with a mortality rate of 1.1%. No death was directly related to the device. After 12 months, a promising overall target lesion revascularization (TLR; 10.1%), non-TLR (6.6%), and major amputation rates (2.3%) were found. One-year mortality was 8%. CONCLUSION: Treatment with PMT resulted in clinic and hemodynamic improvement in the majority of patients, thereby reducing the need for thrombolysis in a significant proportion of patients. Prospective studies in this issue are recommended.

Midterm Results Following Percutaneous Rotational Thrombectomy for Acute Thrombotic Occlusions of Prosthetic Arteriovenous Access Grafts.

Patent vascular access is critical for patients on regular hemodialysis. Prosthetic grafts are good alternatives when the superficial venous system is of poor quality. However, thrombosis is one of the main drawbacks of synthetic grafts, with reports of 59% to 90% patency rates for 1 year. In cases of thrombotic occlusion of prosthetic arteriovenous fistula grafts, percutaneous mechanical thrombectomy has recently gained clinical popularity as a potential alternative to surgical thrombectomy or pharmacologic thrombolysis. We reviewed our preliminary results from 30 percutaneous rotational thrombectomies performed in a total of 22 patients in the setting of acute dialysis-access prosthetic graft occlusion of the upper extremity. Among the 30 cases of acute occlusion of the arteriovenous graft, immediate success with angiographic flow restoration was observed in all patients except for 2 patients (both females; 6%), with de novo occlusion where reocclusion occurred within 12 hours despite apparent immediate angiographic patency. The mean duration between the initial presentation with acute arteriovenous graft occlusion and the thrombectomy procedure was 27.4 ± 12.4 hours. The mean duration of graft patency was 10.45 ± 0.6 months. A total of 75% of the arteriovenous grafts were patent at the end of 12 months of follow-up. Female gender, diabetes mellitus, and diagnosis to intervention interval were reviewed for midterm graft failure, and the presence of diabetes mellitus yielded significance (P < 0.05). Percutaneous techniques play important roles in the treatment of failed or failing arteriovenous fistulae and grafts. Ongoing analysis of outcomes of both percutaneous and surgical intervention is necessary to continue to identify optimum treatment algorithms.

Endovascular treatment of acute limb ischemia and proximal deep vein thrombosis using rotational thrombectomy: A review of published literature.

Acute and subacute ischemia of the lower extremity is still a common reason for amputation. The treatment of this condition includes the well known procedure of local thrombolysis, surgical thrombectomy and, in recent times, percutaneous mechanical thrombectomy procedures such as rotational thrombectomy. However, in randomized studies Fogarty's procedure of surgical thrombectomy was associated with a high rate of perioperative complications and, in part, low technical success rates. On the other hand, local thrombolysis is associated with hemorrhage as well as high costs because of measures requiring substantial resources, such as intensive care monitoring or repeat angiographies. In several studies, the endovascular therapy options of Straub Rotarex® and Aspirex® systems, both products of technical advancements in the field, were shown to be successful in terms of amputation-free survival. Their use was also associated with low complication rates. The majority of studies were focused on arterial blood flow in the femur. However, in the meantime several registers and studies have shown that the systems can also be effectively used to treat proximal deep vein thrombosis. In the present report we review the current study-based value of rotational thrombectomy in the venous and arterial system.

Percutaneous mechanical thrombectomy for treatment of acute femoropopliteal bypass occlusion.

Acute and subacute ischemia of the legs in acute and subacute femoropopliteal bypass occlusion is a dramatic situation that endangers the survival of the limbs, depending on the severity of the ischemia. Different therapy options like percutaneous mechanical thrombectomy procedures, which include rotational thrombectomy, have become available in recent years, in addition to local lysis and surgical thrombectomy. Surgical thrombectomy using the Fogarty catheter technique, in particular, shows an increased incidence of perioperative complications but only small technical success rates in randomized trials. On the other hand, local lysis is associated with increased costs due to resource-consuming measures, such as intensive monitoring and repeat angiographies, in addition to bleeding complications. In the past, further development of the Straub Rotarex(®) system as an endovascular therapy option has demonstrated good success leading to amputation-free survival in multiple studies. At the same time, a low rate of complications with use has been documented. Most examinations have been conducted in the thigh. To date, there are little investigational data on its use in acutely and subacutely occluded femoropopliteal bypasses. In this paper, the current study-based significance of the Rotarex system for this indication is analyzed based on the existing literature and the authors' own experiences with 22 patients.