Economic evaluation of stent retrievers in basilar artery occlusion: An analysis from Chinese healthcare system perspective.

PURPOSE: This study aimed to investigate the cost-effectiveness of stent retriever (SR) versus best medical management (BMM) in patients with basilar artery occlusion (BAO) in China. METHODS: We used a two-step approach to compare the cost-effectiveness of SR plus BMM with that of BMM alone over 20 years. A decision tree was initially constructed for the first 3 months, followed by a Markov model for the subsequent period. Collected data on clinical aspects were extracted from the BAOCHE investigation, while costs-related information was sourced from previously published research. The key metric for evaluating the primary outcome was the incremental cost-effectiveness ratio (ICER), achieved $/QALY. The threshold for identifying SR as highly cost-effective was set at an ICER below $12,551/QALY, SR was deemed cost-effective if the ICER ranged from $12,551 to $37,654 per QALY. Uncertainty was addressed using scenario, one-way sensitivity, and probabilistic sensitivity analyses (PSA). FINDINGS: For Chinese patients with BAO, the 20-year cost per patient was $8678 with BMM alone and $21,988 for SR plus BMM. Effectiveness was 1.45 QALY for BMM alone, and 2.77 QALY for SR plus BMM. The ICER of SR + BMM versus BMM alone was $10,050 per QALY. The scenario and one-way sensitivity analyses revealed that in certain situations the ICER could exceed $12,551 per QALY, but remain below $37,654 per QALY. Results from the PSA suggested that SR was likely to be cost-effective for Chinese patients with BAO, with a probability exceeding 98% when considering a willingness-to-pay (WTP) threshold of $12,551 per QALY. IMPLICATIONS: Our study indicates that SR is an intervention option that is highly likely to be cost-effective for Chinese patients with BAO, with a probability of over 98% under the current WTP threshold of $12,551 per QALY.

Utility of a Mechanical Thrombectomy Device in Treating Calcified Instent Restenosis Post Iliofemoral Venous Stenting.

Instent restenosis (ISR) following iliofemoral venous stenting is quite common with up to three-quarters of patients developing some degree of ISR. However, only around 16% develop recurrent symptoms impairing their quality-of-life meriting reintervention. The first line of treatment for such ISR involves the use of angioplasty balloons to recreate an adequate flow channel. At times such angioplasty alone is inadequate particularly in the presence of calcified ISR. It is in this setting that the authors decided to explore the utility of a mechanical thrombectomy device to debulk the ISR and thereby help create an adequate flow channel. The successful utilization of such a device in a patient presenting with recurrent, disabling, quality of life impairing symptoms due to ISR represents the focus of this report.

Percutaneous Transhepatic AngioJet-assisted Mechanical Thrombectomy for the Treatment of Post-Transplant Portal Vein Thrombosis: A Case Report.

Portal vein thrombosis (PVT) is an uncommon but serious complication after liver transplantation (LT). Treatments for PVT include thrombolysis, surgical treatment or percutaneous intervention. We here report a case of PVT after LT successfully treated by an AngioJet device using the percutaneous transhepatic approach. A 36-year-old male presented with substantial thrombosis of the portal vein/superior mesenteric vein 2 years after a liver transplant. He was managed with an Angiojet thrombectomy and subsequent stent placement. This approach may be a safe and effective treatment for PVT in post-orthotopic LT patients.

Balloon-Assisted Endovascular Thrombectomy for Tibial Thromboembolism.

We present a novel approach to endovascular thrombectomy using the Penumbra Indigo® Aspiration System with balloon assistance for a thromboembolic occlusion to the tibioperoneal trunk and tibial arteries causing acute limb ischemia. This technique allows for effective suction thrombectomy of distal vessels into a shorter, large-diameter aspiration catheter, thereby overcoming the limitations of the longer but smaller aspiration catheters.

Application of the AngioJet Ultra Thrombectomy Device for the Percutaneous Mechanical Treatment (PMT) of Iliac Limb Occlusion after Endovascular Aneurysm Repair (EVAR).

BACKGROUND: To investigate the safety and efficacy of applying the AngioJet Ultra thrombectomy device in treating endograft occlusions in the iliac arteries following endovascular aneurysm repair (EVAR). METHODS: This study utilized a retrospective analysis of 452 patients with infrarenal abdominal aortic aneurysm (AAA). Twelve of the patients experienced iliac limb occlusion during their follow-up period, and the AngioJet Ultra thrombectomy device was used in tandem with iliac angioplasty to treat these patients. The safety of the device was assessed through the amount of blood drawn, the duration of the procedure, and the occurrence of post-operative complications, while its efficacy was assessed through aortic computed tomography angiography (CTA) imaging and post-operative symptomatology results. RESULTS: All 12 patients were male, and they had a mean age of 62.8 ± 11.8 years. Iliac limb occlusion occurred on the left side of 4 patients and on the right side of 8 patients. The AngioJet Ultra thrombectomy device was used together with iliac angioplasty during surgery, with a success rate of 100%. A bifurcated endograft was successfully implanted in 9 patients following AngioJet Ultra thrombectomy and balloon dilation angioplasty, while a unibody endograft was successfully implanted in 3 patients following AngioJet Ultra thrombectomy and balloon dilation angioplasty. The mean surgery duration was 2.4 hrs, and the patients were hospitalized for an average of 4.5 days. After surgery, the patients' intermittent claudication/buttock claudication gradually vanished. Two patients experienced hemoglobinuria, with one of them developing mild renal dysfunction. Currently, the twelve patients have been followed up for an average of 12 months, and none have experienced any lower extremity ischemia. CONCLUSIONS: The use of the AngioJet Ultra thrombectomy device as a supplementary treatment for iliac limb occlusion following abdominal EVAR is safe, effective, and minimally invasive.

Successful IVC thrombus extraction with the AngioVac device following five vessel coronary artery bypass graft: a case report.

BACKGROUND: Inferior vena cava thrombosis is cited to be a complication of inferior vena cava filter placement and post coronary artery bypass surgery. Often only mild symptoms arise from these thrombi; however, due to the chronic nature of some thrombi and the recanalization process, more serious complications can arise. Although anticoagulation remains the gold standard of treatment, some patients are unable to be anticoagulated. In this case, we present a 65-year-old male who underwent IVC filter placement and open-heart surgery who later developed extensive femoral and iliocaval thrombosis leading to right heart failure, which required thrombus extraction with an AngioVac suction device. CASE PRESENTATION: We present a 65-year-old male who presented with bilateral pulmonary emboli with extensive right lower extremity deep vein thrombosis. Upon investigation he had ischemic heart disease and underwent a five-vessel coronary artery bypass for which he had an IVC filter placed preoperatively. On post operative day 3 to 4, he was decompensated and was diagnosed with an IVC thrombus. He progressed to right heart failure and worsening cardiogenic shock despite therapeutic anticoagulation and was taken for a suction thrombectomy using the AngioVac (AngioDynamics, Latham, NY) aspiration thrombectomy device. The thrombectomy was successful and he was able to recover and was discharged from the hospital. CONCLUSION: Despite being a rare complication, IVC thrombosis can have detrimental effects. This case is an example of how IVC thrombus in the post-operative setting can lead to mortality. The gold standard is therapeutic anticoagulation but despite that, this patient continued to have worsening cardiogenic shock. Other therapies have been described but because of its rarity, they are only described in case reports. This case shows that the AngioVac device is a successful treatment option for IVC thrombus and can have the possibility of future use.

AngioVac Aspiration Thrombectomy of Right Atrial Thrombus is Safe and Effective in Cancer Patients.

OBJECTIVES: The aim of this study was to test the hypothesis that endovascular aspiration thrombectomy of right atrial thrombus (RAT) using the AngioVac device is as safe and effective in patients with cancer as those without cancer. BACKGROUND: RAT is a uniquely challenging clinical presentation of venous thromboembolism due to its low incidence and historically high-risk of mortality due to thrombus propagation into the pulmonary arteries. There is a lack of consensus regarding management, particularly in high-risk cancer patients. Endovascular aspiration thrombectomy utilizing the AngioVac device is effective in removal of right atrial thrombus and may be a safer option for patients with cancer in whom avoidance of higher-risk intervention is preferred. METHODS: This was an institutional review board-approved retrospective single-center case control study of patients with RAT who underwent AngioVac aspiration thrombectomy between August 2013 and July 2020. Analysis of patient demographics and clinical characteristics, thrombus-related factors, and operative details was performed. Primary endpoints included survival, safety, and technical success. RESULTS: A total of 44 patients met inclusion criteria, 20 of whom with active malignancy. The oncology group had a significantly higher Charlson comorbidity index (P = 0.01). Comparative outcomes between the oncology and non-oncology group showed no difference in survival (P = 0.8) or technical success (OR 3, 95% CI 0.83-10.9). There were 9 complications, including 6 minor, 1 moderate, 1 severe, and 1 death. CONCLUSIONS: AngioVac aspiration thrombectomy of RAT is as safe and effective in patients with cancer as those without cancer.

Aspiration Thrombectomy with the Indigo System for Acute Lower Limb Ischemia: Preliminary experience and analysis of parameters affecting the outcome.

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.

A Simple Rescue Maneuver to Retrieve Intravascular Foreign Body: The Triple Wire Twisting Technique.

INTRODUCTION: Device fracture causing intravascular foreign body (IFB) is a rare event during endovascular procedures, with potential catastrophic outcome if not promptly removed. We present two cases of retrieval of fractured devices during peripheral lower limb procedures using three guidewires tangled around the IFB. TECHNIQUES: Case 1 was a patient with critical limb ischemia. During balloon angioplasty of a high calcified peroneal artery, the balloon catheter Amphirion Deep 2.5/150 mm (Medtronic) fractured in two pieces, leaving a 20 cm distal part into the artery. Three 0.014" guides were advanced distally the IFB and twisted all together using a single torque-device. It was possible to pull back the long balloon fragment into the popliteal and to reline it inside a 5 French sheath. Case 2 was a patient with acute limb ischemia. During the mechanical thrombo-aspiration using the Indigo System (Penumbra inc.), the distal wire of the olive-shaped separator cracked in the posterior tibial artery. By crossing the IFB with three 0.014" wires and twisting them around it, this 15mm fragment was successfully recaptured. CONCLUSIONS: We named this procedure Triple Wire Twisting Technique and, in our experience, this technique is safe and effective to recapture IFB during complex peripheral procedures. This poorly known rescue technique is not complex and requires materials that are available in all cath-lab. We truly believe that physicians can take advantage of knowing it when facing with IFB in any vessel.

Safety and Efficacy of Vacuum Assisted Thrombo-Aspiration in Patients with Acute Lower Limb Ischaemia: The INDIAN Trial.

OBJECTIVE: The aim was to evaluate the short term safety and effectiveness of the Penumbra/Indigo aspiration thrombectomy Systems (Penumbra Inc.) in patients with acute lower limb ischaemia. (ALLI). Recently, endovascular vacuum assisted thrombectomy devices, similar to those used in the management of acute ischaemic stroke, have become available for peripheral arteries, but data are still scarce. METHODS: To assess vessel patency, a modified Thrombolysis in Myocardial Infarction (TIMI) classification, called TIPI (Thrombo-aspiration In Peripheral Ischaemia), is proposed. The TIPI flow is assessed at presentation, immediately after treatment with the study device, 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 revascularisation TIPI 2 - 3. Safety and clinical success rate were collected at one month. RESULTS: One hundred and fifty patients were enrolled. The mean age was 72.4 years and 73.3% were male. Rutherford grade on enrolment was I in 16%, IIa in 40.7%, and IIb in 43.3% with a mean ankle brachial index of 0.19. Primary technical success (TIPI 2 - 3 flow) was achieved in 88.7% of patients. Adjunctive procedures included angioplasty/stenting of chronic atherosclerotic lesions (n = 39), thrombolysis (n = 31), covered stenting (n = 15), and supplementary Fogarty embolectomy (n = 6). After all interventions, assisted primary technical success was 95.3% (TIPI 2 - 3 in 143/150). No systemic bleeding complications or device related serious adverse events were reported. At one month follow up, one death, and one below the knee amputation were recorded. Primary patency was 92% (138/150), and the re-intervention rate was 7.33%, resulting in an assisted primary and secondary patency of 94% and 99.33%, respectively. CONCLUSION: Results from the INDIAN registry reveal that mechanical thrombectomy using the Indigo system is safe and effective for revascularisation of ALLI as a primary therapy.

Management of Renal Cell Carcinoma With Extensive Caval Thrombosis Utilizing a Temporary Atrial Caval Filter Through a Combined Endovascular and Open Surgical Technique.

The most common cause of neoplastic thrombotic infiltration of the inferior vena cava is renal cell carcinoma (RCC). In the present report we described a case of a patient with massive RCC and extensive neoplastic thrombosis reaching the retrohepatic tract of the inferior vena cava. After a discussion in a multidisciplinary team meeting we decided to perform a radical nephrectomy with vena cava thrombectomy along with the support of a novel removable vena cava filter in order to avoid thromboembolism during the surgical procedure. Furthermore, a preoperative renal artery embolization with a non-adhesive liquid embolic agent was performed ahead of the surgical procedure in order to reduce the risk of intraoperative bleeding. The surgical procedure performed the day after was based on a hybrid endovascular-surgical approach consisting in nephrectomy, liver derotation, cavotomy with the additional use of a novel temporary caval filter, thus reducing the risk of intraoperative thromboembolic dissemination.

MeVO SAVE technique: initial experience with the 167 cm long NeuroSlider 17 for a combined approach in medium vessel occlusions (MeVOs).

Goyal et al described occlusions in M2/3, A2/3 and P2/3 as medium vessel occlusions (MeVOs); the only available controlled data of mechanical thrombectomy (MT) in MeVOs is limited to the middle cerebral artery M2 segment, suggesting that MT may be effective and safe with high functional independence and recanalization rates. The Stent retriever Assisted Vacuum-locked Extraction (SAVE) technique in mechanical thrombectomy consists of the simultaneous use of a stent retriever and a distal aspiration catheter (DAC), with the removal of both as a unit when performing the thrombectomy pass; however, so far the low-profile (0.035 inch distal inner diameter) DACs were longer (160 cm) than conventional 0.017 inch microcatheters for MeVOs. We present a case of a combined approach MT in MeVO with the use of the new 167 cm long NeuroSlider 17 (Acandis, Pforzheim, Germany) 0.0165 inch microcatheter and 3MAX (Penumbra, Alameda, CA) through the SAVE technique-the MeVO SAVE technique. (video 1). neurintsurg;13/8/768/V1F1V1video 1.

Outcomes of Aspirex®S thrombectomy system combined with catheter-directed thrombolysis for treating bilateral lower extremity deep venous thrombosis.

BACKGROUND: Pharmacomechanical catheter-directed thrombolysis (PCDT) is rarely reported in treating bilateral lower extremity deep venous thrombosis (LEDVT). This study was aimed to investigate the safety, patency, and mid-term outcomes of the Aspirex®S thrombectomy system combined with catheter-directed thrombolysis (CDT) in treating symptomatic bilateral LEDVT. PATIENTS AND METHODS: The clinical data of 45 consecutive patients with acute or subacute bilateral LEDVT (60.00% male; mean age, 53.8 ± 16.5 years) who received endovascular treatment with PCDT between January 2015 and June 2019 were retrospectively analyzed in this study. The clinical efficacy of thrombolysis (≥50% thrombolysis), complications, primary patency, valvular function, and cumulative prevalence of post-thrombotic syndrome (PTS) were retrospectively analyzed. RESULTS: PCDT was performed in all 45 patients successfully. No serious procedure-related complication or death was observed. The average urokinase dosage was 4.1 ± 1.5 million IU, and the average thrombolysis time was 5.3 ± 1.3 days. The mean length of hospital stay was 9.9 ± 2.5 days. The primary patency was 100% after lysis. The clinical efficacy of thrombolysis was 86.7% (39/45). Deep venous thrombosis recurrence was observed in six (13.3%) patients within 12 months after discharge. The primary patency at 1-, 3-, 6-, 9-, and 12-month follow-up was 97.8%, 93.3%, 88.9%, 82.2%, and 73.3%, respectively. The cumulative prevalence of PTS was 24.4% (11/45) throughout the follow-up period, whereas the prevalence of moderate and severe PTS was only 6.7% (3/45). CONCLUSIONS: PCDT for treating bilateral LEDVT is feasible, effective, and safe.

Mechanical Thrombectomy of Symptomatic Acute Carotid Stent Thrombosis Using Transcarotid Artery Revascularization Neuroprotection Flow Reversal Technique.

Carotid artery stent thrombosis is a relatively rare yet devastating complication of endovascular carotid interventions and manifests as ipsilateral neurological aberrancies such as transient ischemic attack or cerebrovascular accident. Prompt evaluation is necessary, and appropriate imaging is warranted to ascertain the urgency for intervention. Traditionally, anticoagulation with stent explantation and associated thrombectomy is performed. With patients presenting with more high-risk criteria and medical comorbidities, we describe the successful use of transcarotid artery revascularization flow reversal technique with the Penumbra mechanical thrombectomy device to extirpate the thrombus.

Acute carotid stenting in patients undergoing thrombectomy: a systematic review and meta-analysis.

BACKGROUND: The benefit of acute carotid stenting compared with no acute stenting on clinical outcomes among patients with tandem lesions (TL) undergoing endovascular thrombectomy (EVT) remains unknown. METHODS: We conducted a a systematic review and meta-analysis of studies comparing acute carotid stenting versus no stenting among TL patients undergoing EVT with regards to 90 day modified Rankin Scale (mRS) score, symptomatic intracerebral hemorrhage (sICH), and mortality. Four reviewers screened citations for eligibility and two assessed retained studies for risk of bias and data extraction. A random effects model was used for the synthesis of aggregated data. RESULTS: 21 studies (n=1635 patients) were identified for the systematic review; 19 were cohort studies, 1 was a post-hoc analysis of an EVT trial, and 1 was a pilot randomized controlled trial. 16 studies were included in the meta-analysis. Acute stenting was associated with a favorable 90 day mRS score: OR 1.43 (95% CI 1.07, 1.91). No significant heterogeneity between studies was found for this outcome (I2=17.0%; χ2=18.07, p=0.26). There were no statistically significant differences for 3 month mortality (OR 0.80 (95% CI 0.50, 1.28)) or sICH (OR 1.41 (95% CI 0.91, 2.19)). CONCLUSIONS: This meta-analysis suggests that among TL patients undergoing EVT, acute carotid stenting is associated with a greater likelihood of favorable outcome at 90 days compared with no stenting.

Outcomes of rheolytic thrombectomy in phlegmasia cerulea dolens.

OBJECTIVE: The purpose of this study was to assess the clinical features of phlegmasia cerulea dolens and present the treatment outcomes with rheolytic thrombectomy device. METHODS: From January 2014 and March 2019, 329 patients were diagnosed and hospitalized for acute iliofemoral deep vein thrombosis, and among those patients, seven patients diagnosed with lower extremity phlegmasia cerulea dolens were consecutively enrolled. Diagnosis of phlegmasia cerulea dolens was initially made on clinical findings followed by imaging with Doppler ultrasound. The rheolytic thrombectomy device was used in all patients with a combination of catheter-directed thrombolysis as an adjunctive therapy to facilitate more rapid thrombus clearance except for one patient who had a contraindication to the use of tissue plasminogen activator. RESULTS: Seven patients (four men, three women; median age, 63 years, range 52-68 years) were included. One patient had a relative contradiction to thrombolysis due to history of coronary artery bypass graft surgery; all other patients underwent pharmaco-mechanical thrombectomy with power pulse mode. The upper limit of 480 s was completed in all patients, and this time was not exceeded to prevent hemolysis-related complications. Six Fr catheters were used in four (57.1%) patients, and 8 Fr catheters were used in three patients (42.9%). Mean thrombolytic infusion duration was 28 ± 6.2 h for patients who received tissue plasminogen activator. After catheter-directed thrombolysis, total radiological success was achieved in two patients, and partial radiologic success was achieved in five patients; however, in all seven patients, clinical success was achieved. The mean duration for complete regression of cyanosis was 18.9 ± 8.1 h. Although no patients required blood replacement, mean decreases in hemoglobin and hematocrit were 2.7 ± 1.37 g/dl and 6.42 ± 4.47%, respectively. Acute kidney injury developed in three patients (42.9%). One patient required continuous renal replacement therapy. No cardiac complication was observed. One (14.3%) patient died of ventilator-related pneumonia on postprocedural day 10. The median duration of intensive care unit stay and hospital stay were 72 h (min-max: 24-264 h) and six days (min-max: 5-33 days), respectively. CONCLUSION: Rheolytic thrombectomy was less invasive and effective strategy for early stage phlegmasia cerulea dolens at creating rapid thrombus clearance to establish clinical success and facilitate more conservative management with catheter-directed thrombolysis.