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Multimodal thrombectomy device for treatment of acute deep venous thrombosis.

ABSTRACT: Deep vein thrombosis (DVT) is a potentially deadly medical condition that is costly to treat and impacts thousands of Americans every year. DVT is characterized by the formation of blood clots within the deep venous system of the body. If a DVT dislodges it can lead to venous thromboembolism (VTE) and pulmonary embolism (PE), both of which can lead to significant morbidity or death. Current treatment options for DVT are limited in both effectiveness and safety, in part because the treatment of the DVT cannot be confined to a defined sequestered treatment zone. We therefore developed and tested a novel thrombectomy device that enables the sequesteration of a DVT to a defined treatment zone during fragmentation and evacuation. We observed that, compared to a predicate thrombectomy device, the sequestered approach reduced distal DVT embolization during ex vivo thrombectomy. The sequestered approach also facilitated isovolumetric infusion and suction that enabled clearance of the sequestered treatment zone without significantly impacting vein wall diameter. Results suggest that our novel device using sequestered therapy holds promise for the treatment of high risk large-volume DVTs.

SUBMITTER: Ismail U

PROVIDER: S-EPMC8964697 | biostudies-literature | 2022 Mar

REPOSITORIES: biostudies-literature

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Multimodal thrombectomy device for treatment of acute deep venous thrombosis.

Ismail Usama U Rowe Roger A RA Cashin John J Genin Guy M GM Zayed Mohamed A MA

Scientific reports 20220328 1

Deep vein thrombosis (DVT) is a potentially deadly medical condition that is costly to treat and impacts thousands of Americans every year. DVT is characterized by the formation of blood clots within the deep venous system of the body. If a DVT dislodges it can lead to venous thromboembolism (VTE) and pulmonary embolism (PE), both of which can lead to significant morbidity or death. Current treatment options for DVT are limited in both effectiveness and safety, in part because the treatment of t ...[more]

PMID: 35351922

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Project description:AbstractDeep venous thrombosis (DVT) is associated with high mortality in coronavirus disease 2019 (COVID-19) but there remains uncertainty about the benefit of anti-coagulation prophylaxis and how to decide when ultrasound screening is indicated. We aimed to determine parameters predicting which COVID-19 patients are at risk of DVT and to assess the benefit of prophylactic anti-coagulation.Adult hospitalized patients with positive severe acute respiratory syndrome coronavirus-2 reverse transcription-polymerase chain reaction (RT-PCR) undergoing venous duplex ultrasound for DVT assessment (n = 451) were retrospectively reviewed. Clinical and laboratory data within 72 hours of ultrasound were collected. Using split sampling and a 10-fold cross-validation, a random forest model was developed to find the most important variables for predicting DVT. Different d-dimer cutoffs were examined for classification of DVT. We also compared the rate of DVT between the patients going and not going under thromboprophylaxis.DVT was found in 65 (14%) of 451 reverse transcription-polymerase chain reaction positive patients. The random forest model, trained and cross-validated on 2/3 of the original sample (n = 301), had area under the receiver operating characteristic curve = 0.91 (95% confidence interval [CI]: 0.85-0.97) for prediction of DVT in the test set (n = 150), with sensitivity = 93% (95%CI: 68%-99%) and specificity = 82% (95%CI: 75%-88%). The following variables had the highest importance: d-dimer, thromboprophylaxis, systolic blood pressure, admission to ultrasound interval, and platelets. Thromboprophylaxis reduced DVT risk 4-fold from 26% to 6% (P < .001), while anti-coagulation therapy led to hemorrhagic complications in 14 (22%) of 65 patients with DVT including 2 fatal intra-cranial hemorrhages. D-dimer was the most important predictor with area under curve = 0.79 (95%CI: 0.73-0.86) by itself, and a 5000 ng/mL threshold at 7 days postCOVID-19 symptom onset had 75% (95%CI: 53%-90%) sensitivity and 81% (95%CI: 72%-88%) specificity. In comparison with d-dimer alone, the random forest model showed 68% versus 32% specificity at 95% sensitivity, and 44% versus 23% sensitivity at 95% specificity.D-dimer >5000 ng/mL predicts DVT with high accuracy suggesting regular monitoring with d-dimer in the early stages of COVID-19 may be useful. A random forest model improved the prediction of DVT. Thromboprophylaxis reduced DVT in COVID-19 patients and should be considered in all patients. Full anti-coagulation therapy has a risk of life-threatening hemorrhage.

Dataset Information

Multimodal thrombectomy device for treatment of acute deep venous thrombosis.

Publications

Multimodal thrombectomy device for treatment of acute deep venous thrombosis.

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