Safety and efficacy of mechanical aspiration thrombectomy for patients with acute lower extremity ischemia.

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.

One-year limb salvage and quality of life following mechanical aspiration thrombectomy in patients with acute lower extremity ischemia.

OBJECTIVE: Lower extremity acute limb ischemia (LE-ALI) is associated with high morbidity and mortality rates, and a burden on patient quality of life (QoL). There is limited medium- to long-term evidence on mechanical aspiration thrombectomy (MT) in patients with LE-ALI. The STRIDE study was designed to assess safety and efficacy of MT using the Indigo Aspiration System in patients with LE-ALI. Thirty-day primary and secondary endpoints and additional outcomes were previously published. Here, we report 365-day secondary endpoints and QoL data from STRIDE. METHODS: STRIDE was a multicenter, prospective, single-arm, observational cohort study that enrolled 119 patients across 16 sites in the United States and Europe. Patients were treated first-line with MT using the Indigo Aspiration System (Penumbra, Inc). The study completed follow-up in October 2023. Secondary endpoints at 365 days included target limb salvage and mortality. Additionally, the VascuQoL-6 questionnaire, developed for evaluating patient-centered QoL outcomes for peripheral arterial disease, was assessed at baseline and follow-up through 365 days. RESULTS: Seventy-three percent of patients (87/119) were available for 365-day follow-up. Mean age of these patients was 65.0 ± 13.3 years, and 44.8% were female. Baseline ischemic severity was classified as Rutherford I in 12.6%, Rutherford IIa in 51.7%, and Rutherford IIb in 35.6%. In general, baseline and disease characteristics (demographics, medical history, comorbidities, target thrombus) of these patients are similar to the enrolled cohort of 119 patients. The secondary endpoints at 365 days for target limb salvage was 88.5% (77/87) and mortality rate was 12.0% (12/100). VascuQoL-6 improved across all domains, with a median total score improvement from 12.0 (interquartile range, 9.0-15.0) at baseline to 19.0 (interquartile range, 16.0-22.0) at 365 days. CONCLUSIONS: These 365-day results from STRIDE demonstrate that first-line MT with the Indigo Aspiration System for LE-ALI portray continued high target limb salvage rates and improved patient-reported QoL. These findings indicate Indigo as a safe and effective therapeutic option for LE-ALI.

Intravascular Ultrasound Use in Peripheral Arterial and Deep Venous Interventions: Multidisciplinary Expert Opinion From SCAI/AVF/AVLS/SIR/SVM/SVS.

Percutaneous revascularization is the primary strategy for treating lower extremity venous and arterial disease. Angiography is limited by its ability to accurately size vessels, precisely determine the degree of stenosis and length of lesions, characterize lesion morphology, or correctly diagnose postintervention complications. These limitations are overcome with use of intravascular ultrasound (IVUS). IVUS has demonstrated the ability to improve outcomes following percutaneous coronary intervention, and there is increasing evidence to support its benefits in the setting of peripheral vascular intervention. At this stage in its evolution, there remains a need to standardize the use and approach to peripheral vascular IVUS imaging. This manuscript represents considerations and consensus perspectives that emerged from a roundtable discussion including 15 physicians with expertise in interventional cardiology, interventional radiology, and vascular surgery, representing 6 cardiovascular specialty societies, held on February 3, 2023. The roundtable's aims were to assess the current state of lower extremity revascularization, identify knowledge gaps and need for evidence, and determine how IVUS can improve care and outcomes for patients with peripheral arterial and deep venous pathology.

Duplex Ultrasound Surveillance after Transcarotid Artery Revascularization (TCAR) in Clinical Practice.

BACKGROUND: To propose a protocol for the routine clinical use of duplex ultrasound (DUS) assessment after transcarotid artery revascularization (TCAR) procedures, with its specific point of vascular access, based on DUS data from routine clinical practice. METHODS: DUS data were retrospectively collected at 2 centers from a total of 97 patients who underwent a TCAR procedure with at least 30-day and up to 12-month follow-up. Peak systolic velocity (PSV), end diastolic velocity (EDV), and the internal carotid artery (ICA)/common carotid artery (CCA) PSV ratio were collected at baseline (≤30 days after the procedure) and compared with subsequent measurements. RESULTS: Baseline data were established within 30 days after the procedure. There were no access site stenoses, pseudoaneurysms, or dissections detected in follow-up. Average hemodynamics measurements at 12 months after the procedure (36% of patients reached this time point to date) were PSV 167 ± 153 cm/sec, EDV 51 ± 55 cm/sec, and ICA/CCA PSV 2.3 ± 1.9. Five patients (5.2%) exhibited velocities indicative of ≥80% in-stent restenosis (ISR) at 12 months after the procedure. Two patients (2.1%) underwent repeat intervention for ISR based on high velocities and before significant clinical consequence. The other 3 patients (3.1%) were asymptomatic and are being managed medically and monitored for neurological symptoms. One intraprocedural stroke (1.0% of total treated) was observed. CONCLUSIONS: This protocol not only illustrates the utility of using the CCA for the arterial access sheath for carotid stenting, but also successfully identifies patients with clinically significant restenosis >80%-99%. A surveillance regimen of baseline at ≤30 days after the procedure, followed by assessment at 6 and 12 months, and yearly thereafter appears to be a safe and effective protocol, based on the data available to date. A PSV >340 cm/sec and ICA/CCA ratio >4.15 is consistent with an 80-99% restenosis after TCAR. Although a small number, this study serves as a starting point for those who perform TCAR to specifically look at the CCA access site to rule out these potential pitfalls which did occur in the early trials.

Lower Extremity Revascularization Using Optical Coherence Tomography-Guided Directional Atherectomy: Final Results of the EValuatIon of the PantheriS OptIcal COherence Tomography ImagiNg Atherectomy System for Use in the Peripheral Vasculature (VISION) Study.

PURPOSE: To evaluate the safety and efficacy of a novel optical coherence tomography (OCT)-guided atherectomy catheter in treating patients with symptomatic femoropopliteal disease. METHODS: The VISION trial ( ClinicalTrials.gov identifier NCT01937351) was a single-arm, multicenter, global investigational device exemption study enrolling 158 subjects (mean age 67.2±10.5 years; 87 men) across 20 participating sites. In this cohort, 198 lesions were treated with an average length of 53±40 mm using the Pantheris catheter alone or Pantheris + adjunctive therapy. The primary safety endpoint was the composite of major adverse events (MAEs) through 6 months (objective performance goal 43.2%). Technical success (primary efficacy outcome) was defined as the percent of target lesions with a residual diameter stenosis ≤50% after treatment with the Pantheris device alone (objective performance goal 87.0%). Procedural success was defined as reduction in stenosis to ≤30% after Pantheris ± adjunctive therapy. Tissue specimens retrieved from each treated lesion were histologically analyzed to evaluate the accuracy and precision of OCT image guidance. RESULTS: The primary efficacy outcome was achieved in 192 (97.0%) of the 198 lesions treated with the Pantheris catheter. Across all lesions, mean diameter stenosis was reduced from 78.7%±15.1% at baseline to 30.3%±11.8% after Pantheris alone (p<0.001) and to 22.4%±9.9% after Pantheris ± adjunctive therapy (p<0.001). Of the 198 target lesions, 104 (52.5%) were treated with the Pantheris alone, 84 (42.4%) were treated with Pantheris + adjunctive angioplasty, and 10 (5.1%) with Pantheris + angioplasty + stenting. The composite MAE outcome through 6 months occurred in 25 (16.6%) of 151 subjects. There were no clinically significant perforations, 1 (0.5%) catheter-related dissection, 4 (2%) embolic events, and a 6.4% clinically driven target lesion revascularization rate at 6 months. The 40-lesion chronic total occlusion (CTO) subset (mean lesion length 82±38 mm) achieved a similar significant reduction in stenosis to 35.5%±13.6% after Pantheris alone (p<0.001). Histological analysis of atherectomy specimens confirmed <1% adventitia in 82.1% of the samples, highlighting the precision of OCT guidance. Characterization of the OCT-guided lesions revealed evidence of an underestimation of disease burden when using fluoroscopy. CONCLUSION: OCT-guided atherectomy for femoropopliteal disease is safe and effective. Additionally, the precision afforded by OCT guidance leads to greater removal of plaque during atherectomy while sparing the adventitia.

Initial Experiences with Endovascular Management of Submassive Pulmonary Embolism: Is It Safe?

BACKGROUND: Interventional strategies for massive and submassive pulmonary embolism (smPE) have historically included either systematic intravenous thrombolytic alteplase or surgical embolectomy, both of which are associated with significant morbidity and mortality. However, with the advent of endovascular techniques, recent studies have suggested that an endovascular approach to the treatment of acute smPE may be both safe and effective with excellent outcomes. The purpose of this study was to evaluate the outcomes of patients who have undergone catheter-directed thrombolysis (CDT) for smPE at our institution in an effort to determine the safety of the procedure. METHODS: A retrospective review was conducted from December 2012 to June 2015 to identify patients whom underwent CDT in the treatment of a smPE at our institution. Primary measure was safety of the procedure. Outcome variables were classified as serious or minor adverse events. Serious events included death, stroke, myocardial infarction, and bleeding complications requiring surgical intervention or transfusion. Minor events included groin hematoma, development of arteriovenous fistula, and bleeding requiring interruption or cessation of CDT. In addition, a secondary measure included effectiveness of CDT based on preinterventional and postinterventional clinical examination and radiographic findings. RESULTS: A total of 27 patients undergoing CDT for smPE at our institution were evaluated. The standard procedure included access via bilateral femoral veins and placement of bilateral EKOS catheters for ultrasound-assisted thrombolysis (USAT), with Activase (alteplase) at 1 mg per hour in each catheter for a total of 12 hr. There were no serious adverse events and only 4 patients (14.8%) had minor events, of which only 1 patient required premature termination of therapy due to bleeding resulting in a 3.7% clinically relevant bleeding rate. In addition, a reduction in a right-to-left ventricular end-diastolic diameter ratio (RV/LV ratio) on follow-up imaging was observed in each of the 18 patients where preinterventional and postinterventional imaging was available. Likewise, via chart review, all patients reported significant cessation of shortness-of-breath and resolution of chest pain with associated decrease in supplemental oxygen requirement. CONCLUSIONS: Current evidence, the majority of which has been industry funded, suggests that CDT should be considered as the first-line therapy for smPE. Our experience, in this single-institution retrospective review, demonstrates that CDT with USAT in the treatment of smPE is safe, while providing immediate resolution of both RV strain and clinical symptoms such as shortness-of-breath and chest pain. We hope that these data will allow other institutions to consider CDT as a plausible option in the treatment of smPE.

New Diagnostic Tools for Pulmonary Embolism Detection.

The presentation of pulmonary embolism (PE) varies from asymptomatic to life-threatening, and management involves multiple specialists. Timely diagnosis of PE is based on clinical presentation, D-dimer testing, and computed tomography pulmonary angiogram (CTPA), and assessment by a Pulmonary Embolism Response Team (PERT) is critical to management. Artificial intelligence (AI) technology plays a key role in the PE workflow with automated detection and flagging of suspected PE in CTPA imaging. HIPAA-compliant communication features of mobile and web-based applications may facilitate PERT workflow with immediate access to imaging, team activation, and real-time information sharing and collaboration. In this review, we describe contemporary diagnostic tools, specifically AI, that are important in the triage and diagnosis of PE.

Transcarotid repair of carotid artery pseudoaneurysm after carotid artery endarterectomy with tandem distal internal carotid artery stenosis.

Pseudoaneurysm development after carotid endarterectomy is a rare occurrence. Even rarer is pseudoaneurysm formation associated with a distal carotid artery stenosis. We report the case of stent grafting of a carotid artery pseudoaneurysm and tandem high-grade distal stenosis through a transcarotid approach with active flow reversal. No reported cases of a transcarotid artery approach to address a carotid artery aneurysm with tandem stenosis were found in the literature. We show that it may be a safe alternative to a transfemoral artery approach or open surgery.

Use of vacuum-assisted closure (VAC) therapy in treating lymphatic complications after vascular procedures: new approach for lymphoceles.

OBJECTIVE: Lymphatic complications, such as lymphocutaneous fistula (LF) and lymphocele, are relatively uncommon after vascular procedures, but their treatment represents a serious challenge. Vacuum assisted closure (VAC) therapy has been reported to be an effective therapeutic option for LF, but the effectiveness of VAC therapy for lymphoceles is unclear. METHODS: For LF, we apply the VAC directly to the skin defect after extending it to achieve a clean wound of at least one inch in length. To treat lymphocele, we convert the lymphocele to a LF in a sterile fashion by making a one inch incision in the overlying skin and applying the VAC. The setting was a community teaching hospital. We used 10 patients that we treated with VAC therapy for LF (n = 4) and lymphoceles (n = 6). RESULTS: Duration of in-patient stay, duration of in-patient VAC treatment, duration of out-patient VAC treatment, total duration of VAC treatment. The median duration of in-patient stay was 4 (range, 0-18) days, the median duration of in-patient VAC treatment was 1 (range, 0-5) days, the median duration of out-patient VAC treatment was 16 (range, 7-28) days), and the median total duration of VAC therapy was 18 (range, 13-29) days. Successful wound healing was achieved in all patients with no recurrence after VAC removal. VAC therapy for treatment of both LFs and lymphoceles resulted in early control of drainage, rapid wound closure, and short hospital stays. CONCLUSION: Our results suggest that VAC therapy is a convenient and effective therapeutic option for both LFs and lymphoceles.

A multidisciplinary approach to carotid paragangliomas.

The surgical management of carotid paragangliomas can be problematic. A multidisciplinary approach was used to include vascular surgery, otolaryngology, and neuroradiology to treat these patients over 9 years. From January 1992 to July 2001, a multidisciplinary team evaluated patients with carotid paragangliomas. Analyzed patient data included age, gender, diagnostic evaluation, tumor size, preoperative tumor embolization, operative exposure, need for extracranial arterial sacrifice/reconstruction, postoperative morbidity including cranial nerve dysfunction, and long-term follow-up. Twenty-five carotid paragangliomas in 20 patients underwent multidisciplinary evaluation and management. Average age was 51 years (range, 28-83 years), and 52% were male. Diagnostic evaluation included computed tomography in 76%, magnetic resonance imaging/magnetic resonance angiography in 52%, catheter angiography in 60%, and duplex ultrasonography in 16%. An extended neck exposure was required in 11 cases (44%), mandibulotomy was used once (4%), and mandibular subluxation was never required. The external carotid artery (ECA) was sacrificed in 8 cases (32%). The carotid bifurcation was resected in 1 patient (4%) requiring interposition reconstruction of the internal carotid artery. Preoperative tumor embolization was performed for 13 tumors (52%). Operative blood loss for patients undergoing preoperative embolization (Group I) was comparable to the nonembolized group (group II): group I lost 365 +/-180 mL versus 360 +/- 101 mL for group II (P = .48). This occurred despite larger tumors (group I - 4.2 cm versus group II - 2.1 cm, P = .03) and a higher mean Shamblin class (group I - 2.5 versus group II - 1.45, P = .001) for group I. There were no perioperative mortalities. Transient cranial nerve dysfunction occurred in 13 CBTs (52%), 2 (8%) of which remained present after 4 months. Patients with carotid paragangliomas benefit from a multidisciplinary team approach. Neuroradiology has been used for selective preoperative embolization, which has decreased estimated blood loss during excision of larger complex tumors. A combined surgical team of otolaryngology and vascular surgery provides for exposure of the distal internal carotid artery as high as the skull base, limited permanent cranial nerve dysfunction, and selective early division and excision of the external carotid artery for complete tumor resection.

Venous duplex and pathologic differences in thrombus characteristics between de novo deep vein thrombi and endovenous heat-induced thrombi.

OBJECTIVE: Superficial venous reflux disease has been treated with endovenous ablation techniques for more than 15 years. Thrombi discovered in the postoperative period are referred to as endovenous heat-induced thrombi (EHIT). In spite of the few studies of the ultrasound differentiation between EHIT and deep vein thrombi (DVT), there remains a paucity of literature regarding the evaluation of ultrasound examination and pathologic differentiation. METHODS: Six Yorkshire cross swine underwent femoral vein thrombosis by suture ligation or endovenous radiofrequency ablation. At 1 week after the procedure, each femoral vein was imaged by color Duplex ultrasound and sent for histologic interpretation for differentiation between EHIT and DVT. Five blinded vascular surgery faculty, two vascular surgery fellows, and three vascular surgery residents reviewed the ultrasound images. RESULTS: Thrombi associated with radiofrequency ablation demonstrated a greater degree of hypercellular response, fibroblastic reaction, and edema (3.42 vs 2.92; 3.75 vs 2.42; 2.83 vs 1.33). Specimens harvested from the iatrogenic-induced DVT swine demonstrated a more prolific response to trichrome staining (3.42 vs 2.67). Evidence of revascularization was found in all of the EHIT specimens but in 33% of DVT specimens. On the basis of histologic findings, the pathologist predicted correct modality 92% of the time. Subgroup analysis comparing paired specimens from each swine failed to demonstrate any marked pathologic differences. Recorded ultrasound images from EHIT and DVT samples were reviewed by fellows, residents, and vascular surgery staff to determine whether clot was stationary or free-floating (n = 111; 93%), evidence of retracted or adherent vein (n = 105; 88%), and absence of color flow (n = 102; 85%). The degree of occlusion (partial vs total) and degree of distention of a visualized vein were least likely to be agreed on by reviewers (n = 95; 79% each, respectively). In subgroup (DVT vs EHIT) analyses, the percentage agreement was greatest among vascular surgery fellows (89% and 92%) compared with residents (82% and 79%) and faculty (78% and 77%). CONCLUSIONS: It is possible to differentiate the thrombus origin on pathologic examination but not clinically on ultrasound. Wide variability exists for ultrasound diagnosis of EHIT and de novo DVT. Care must be taken in evaluating post-treatment duplex scans to not assign diagnosis of EHIT when DVT may well be present and extending into the deep venous system. The modulation of collagen production in the treatment of DVT may be helpful in preventing vascular dysfunction and reducing the post-thrombotic changes. Further studies on injury after radiofrequency ablation and laser ablation are needed.

Blunt injury to the external iliac artery: a case report.

Blunt vascular trauma is rare as compared with penetrating vascular trauma. The incidence of iliac artery injury has been reported as low as 0.4 per cent of total arterial trauma. Iliac artery injury in blunt trauma is rare because of its anatomic location and protection by the pelvis. This article presents a case of external iliac artery injury secondary to blunt trauma. A deceleration-type mechanism is suggested that results in the production of an intimal flap and later vessel thrombosis. We discuss the clinical details of presentation and angiographic diagnosis as well as treatment options.