Safety and Effectiveness of Mechanical Thrombectomy From the Fully Enrolled Multicenter, Prospective CLOUT Registry

Dexter, David J.; Kado, Herman; Shaikh, Abdullah; Schor, Jonathan; Annambhotla, Suman; Zybulewski, Adam; Paulisin, Joseph; Bisharat, Mohannad; Mouawad, Nicolas J.; Bunte, Matthew C.; Maldonado, Thomas S.; Skripochnik, Edvard; Raskin, Adam; Gandhi, Sagar S.; Ichinose, Eugene; Beasley, Robert E.; Mojibian, Hamid

doi:10.1016/j.jscai.2023.100585

Cited by 10 publications

(14 citation statements)

References 27 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Mechanical thrombectomy with this system appears safe and effective; in the 500-patient ClotTriever Outcomes (CLOUT) registry, the device-related serious adverse event rate was .2%, with a median estimated blood loss of 40.0 mL, and 91.2% of limbs demonstrating ≥75% thrombus extraction despite the presence of nonacute DVT in over two-thirds of the limbs. [1][2][3][4] Still, the chance for adverse events is heightened in cases of complex DVT. 6 The ClotTriever catheter is designed for use in veins with a maximum diameter of 16 mm, smaller than the IVC diameter of many adult patients.…”

Section: Discussionmentioning

confidence: 99%

“…Recent advances in mechanical thrombectomy devices designed to treat deep vein thrombosis (DVT) have led to significant improvements in the effectiveness and safety of interventional procedures. [1][2][3][4] However, the risk of potentially life-threatening thrombus embolization remains when treating complex DVT, 5 which includes cases of inferior vena cava (IVC) thrombosis. 6 The central location of IVC thrombus makes it particularly susceptible to mobilization during thrombectomy procedures.…”

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Intraprocedural Use of the Novel Protrieve Sheath Removes Embolus During Mechanical Thrombectomy of a Complex Iliocaval Deep Vein Thrombosis

Reynolds

2023

Vasc Endovascular Surg

View full text Add to dashboard Cite

Extension of proximal deep vein thrombosis (DVT) into the inferior vena cava (IVC) complicates treatment with mechanical thrombectomy, as the presence of IVC thrombus increases embolization risks. In the case of a 39-year-old man with left-sided iliocaval DVT, the novel Protrieve sheath (Inari Medical, Irvine, California) was intraprocedurally placed in the IVC to ensure such complications would not outweigh the benefits of intervention. During successful thrombectomy, the sheath’s wall-apposing funnel trapped and removed procedural embolus from the IVC, with no complications occurring. Studies to determine whether the device can broadly improve the safety of complex DVT procedures are warranted.

show abstract

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Intraprocedural Use of the Novel Protrieve Sheath Removes Embolus During Mechanical Thrombectomy of a Complex Iliocaval Deep Vein Thrombosis

Reynolds

2023

Vasc Endovascular Surg

View full text Add to dashboard Cite

show abstract

“…This window offers an opportunity for reperfusion therapies to restore blood flow and limit cerebral damage 13 . Currently, the two primary therapies employed during this stage are intravenous thrombolysis (IVT) 14,15 and mechanical thrombectomy (MT) 16–19 …”

Section: Introductionmentioning

confidence: 99%

“…13 Currently, the two primary therapies employed during this stage are intravenous thrombolysis (IVT) 14,15 and mechanical thrombectomy (MT). [16][17][18][19] IVT involves the administration of a thrombolytic agent, such as tissue plasminogen activator (tPA), which dissolves the clot obstructing the cerebral artery. IVT has been demonstrated to improve outcomes in patients with acute ischemic stroke within the first 4.5-h. 14,15,[20][21][22] In 1996, the Food and Drug Administration (FDA) approved intravenous-tPA (IV-tPA) for treating acute ischemic stroke, based on successful outcomes in the National Institute of Neurological Disorders and Stroke study.…”

mentioning

confidence: 99%

Hemiplegia in acute ischemic stroke: A comprehensive review of case studies and the role of intravenous thrombolysis and mechanical thrombectomy

Carrillo Navarrete,

Chapa González

2024

Ibrain

View full text Add to dashboard Cite

Acute ischemic stroke is a significant health concern worldwide, often leading to long‐term disability and decreased quality of life. Rapid and appropriate treatment is crucial for achieving optimal outcomes in these patients. Intravenous thrombolysis (IVT) and mechanical thrombectomy (MT) are two commonly used interventions for acute ischemic stroke, but their effectiveness in improving neurological symptoms and functional outcomes in patients with hemiplegia remains uncertain. The aim of this work was to evaluate the impact of IVT and MT within a 4.5‐h time frame on patients with acute ischemic stroke and hemiplegia. A systematic review was conducted following the Preferred Reporting Items for Systematic Reviews and Meta‐Analyses guidelines. Relevant studies that assessed the impact of IVT and MT within 4.5‐h on hemiplegia in patients with an acute ischemic stroke were included. Data were extracted and analyzed to determine the overall effects of these interventions. Most included case reports indicate positive outcomes in terms of neurological symptom improvement and functional recovery in patients with hemiplegia after receiving IVT and MT within the specified time frame. However, the heterogeneity among the patients and the limited use of IVT due to contraindications posed challenges in determining the most effective treatment option. The findings from the included studies demonstrate that both interventions led to a decrease in National Institutes of Health Stroke Scale scores, indicating an improvement in neurological symptoms. The results highlight the beneficial effects of early thrombolytic interventions and MT on the neurological status and functional outcomes of patients with an acute ischemic stroke.

show abstract

“…Interventional DVT treatment aimed at removing thrombus may improve the longer-term outcomes of patients by reducing venous obstruction (9,10). The ClotTriever System (Inari Medical, Irvine, CA) is a percutaneous mechanical thrombectomy (PMT) device shown to be effective in removing thrombus in veins affected by DVT with acute or chronic presentation (11)(12)(13)(14). The ClotTriever BOLD catheter (Inari Medical, Irvine, CA, USA) is a newer addition to the system that has a coring element with an increased wall thickness compared with the legacy device.…”

Section: Introductionmentioning

confidence: 99%

Single-center experience with the ClotTriever BOLD catheter for deep vein thrombosis percutaneous mechanical thrombectomy of the lower extremity

De Marco Garcia

2023

Front. Surg.

View full text Add to dashboard Cite

BackgroundThe ClotTriever System is a percutaneous mechanical thrombectomy system used to treat deep vein thrombosis (DVT). The BOLD catheter is a newer compatible component with a modified coring element for which reported outcomes are limited. This retrospective study aims to assess the preliminary procedural safety and success data for patients treated with the BOLD catheter.MethodsAll consecutive patients with symptomatic lower extremity DVT who underwent thrombectomy with the BOLD catheter between 23 November 2021 and 26 June 2022 at a single center were included. Baseline and procedural characteristics were reported. The primary outcome, intraprocedural safety, was assessed by a chart review of recorded intraprocedural adverse events (AEs) or device malfunction. The secondary outcome, procedural success, was defined as ≥75% reduction in the total occlusion across treated venous segments. This was assessed by an interventionalist review of pre- and postprocedural venograms. Additional outcomes included length of postprocedural hospital stay and assessment of AEs at discharge and a 30-day follow-up visit.ResultsEleven patient cases were reviewed. The median patient age was 65 years, the majority were women, and all were treated unilaterally. All procedures were completed in a single session without intraprocedural AEs or device malfunction. The median procedural blood loss was 50 ml. A review of pre- and postprocedural venograms showed that 35 venous segments were treated, including the femoral (n = 9), common femoral (n = 9), external iliac (n = 10), and common iliac (n = 7) veins. Procedural success was achieved in 10 patients (90.9%), and the median reduction rate in venous occlusion was 100%. The median length of postprocedural hospital stay was 1 day, and no AEs were noted at discharge (N = 11). One adverse event occurred among the eight patients who completed their follow-up visit. A patient with advanced-stage cancer and medication failure had a recurrent DVT 13 days postprocedure, which was not related to the device or procedure.ConclusionsNo safety concerns concerning the BOLD catheter were raised during the review of the cases included in this analysis, and the device was successful in reducing venous occlusion in patients with symptomatic proximal lower extremity DVT.

show abstract

Safety and Effectiveness of Mechanical Thrombectomy From the Fully Enrolled Multicenter, Prospective CLOUT Registry

Cited by 10 publications

References 27 publications

Intraprocedural Use of the Novel Protrieve Sheath Removes Embolus During Mechanical Thrombectomy of a Complex Iliocaval Deep Vein Thrombosis

Intraprocedural Use of the Novel Protrieve Sheath Removes Embolus During Mechanical Thrombectomy of a Complex Iliocaval Deep Vein Thrombosis

Hemiplegia in acute ischemic stroke: A comprehensive review of case studies and the role of intravenous thrombolysis and mechanical thrombectomy

Single-center experience with the ClotTriever BOLD catheter for deep vein thrombosis percutaneous mechanical thrombectomy of the lower extremity

Contact Info

Product

Resources

About