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Non-Invasive Thrombolysis Using Microtripsy in a Porcine Deep Vein Thrombosis Model.

ABSTRACT: Histotripsy is a non-invasive therapeutic technique that uses ultrasound generated from outside the body to create controlled cavitation in targeted tissue, and fractionates it into acellular debris. We have developed a new histotripsy approach, termed microtripsy, to improve targeting accuracy and to avoid collateral tissue damage. This in vivo study evaluates the safety and efficacy of microtripsy for non-invasive thrombolysis in a porcine deep vein thrombosis model. Acute thrombi were formed in left femoral veins of pigs (?35 kg) by occluding the vessel using two balloon catheters and infusing with thrombin. Guided by real-time ultrasound imaging, microtripsy thrombolysis treatment was conducted in 14 pigs; 10 pigs were euthanized on the same day (acute) and 4 at 2 wk (subacute). To evaluate vessel damage, 30-min free-flow treatment in the right femoral vein (no thrombus) was also conducted in 8 acute pigs. Blood flow was successfully restored or significantly increased after treatment in 13 of the 14 pigs. The flow channels re-opened by microtripsy had a diameter up to 64% of the vessel diameter (?6 mm). The average treatment time was 16 min per centimeter-long thrombus. Only mild intravascular hemolysis was induced during microtripsy thrombolysis. No damage was observed on vessel walls after 2 wk of recovery, venous valves were preserved, and there was no sign of pulmonary embolism. The results of this study indicate that microtripsy has the potential to be a safe and effective treatment for deep vein thrombosis in a porcine model.

SUBMITTER: Zhang X

PROVIDER: S-EPMC5440202 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature

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Non-Invasive Thrombolysis Using Microtripsy in a Porcine Deep Vein Thrombosis Model.

Zhang Xi X Macoskey Jonathan J JJ Ives Kimberly K Owens Gabe E GE Gurm Hitinder S HS Shi Jiaqi J Pizzuto Matthew M Cain Charles A CA Xu Zhen Z

Ultrasound in medicine & biology 20170428 7

Histotripsy is a non-invasive therapeutic technique that uses ultrasound generated from outside the body to create controlled cavitation in targeted tissue, and fractionates it into acellular debris. We have developed a new histotripsy approach, termed microtripsy, to improve targeting accuracy and to avoid collateral tissue damage. This in vivo study evaluates the safety and efficacy of microtripsy for non-invasive thrombolysis in a porcine deep vein thrombosis model. Acute thrombi were formed ...[more]

PMID: 28457630

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Project description:BackgroundThe post-thrombotic syndrome frequently develops in patients with proximal deep-vein thrombosis despite treatment with anticoagulant therapy. Pharmacomechanical catheter-directed thrombolysis (hereafter "pharmacomechanical thrombolysis") rapidly removes thrombus and is hypothesized to reduce the risk of the post-thrombotic syndrome.MethodsWe randomly assigned 692 patients with acute proximal deep-vein thrombosis to receive either anticoagulation alone (control group) or anticoagulation plus pharmacomechanical thrombolysis (catheter-mediated or device-mediated intrathrombus delivery of recombinant tissue plasminogen activator and thrombus aspiration or maceration, with or without stenting). The primary outcome was development of the post-thrombotic syndrome between 6 and 24 months of follow-up.ResultsBetween 6 and 24 months, there was no significant between-group difference in the percentage of patients with the post-thrombotic syndrome (47% in the pharmacomechanical-thrombolysis group and 48% in the control group; risk ratio, 0.96; 95% confidence interval [CI], 0.82 to 1.11; P=0.56). Pharmacomechanical thrombolysis led to more major bleeding events within 10 days (1.7% vs. 0.3% of patients, P=0.049), but no significant difference in recurrent venous thromboembolism was seen over the 24-month follow-up period (12% in the pharmacomechanical-thrombolysis group and 8% in the control group, P=0.09). Moderate-to-severe post-thrombotic syndrome occurred in 18% of patients in the pharmacomechanical-thrombolysis group versus 24% of those in the control group (risk ratio, 0.73; 95% CI, 0.54 to 0.98; P=0.04). Severity scores for the post-thrombotic syndrome were lower in the pharmacomechanical-thrombolysis group than in the control group at 6, 12, 18, and 24 months of follow-up (P<0.01 for the comparison of the Villalta scores at each time point), but the improvement in quality of life from baseline to 24 months did not differ significantly between the treatment groups.ConclusionsAmong patients with acute proximal deep-vein thrombosis, the addition of pharmacomechanical catheter-directed thrombolysis to anticoagulation did not result in a lower risk of the post-thrombotic syndrome but did result in a higher risk of major bleeding. (Funded by the National Heart, Lung, and Blood Institute and others; ATTRACT ClinicalTrials.gov number, NCT00790335 .).

Project description:Additional catheter-directed thrombolysis (CDT) for acute deep vein thrombosis (DVT) reduces long-term postthrombotic syndrome and is likely to represent a cost-effective alternative treatment compared to the standard treatment of anticoagulation and elastic compression stockings. Accelerated thrombus resolution has also been suggested to improve symptoms and patient function in the acute phase. We aimed to investigate whether additional CDT led to fewer symptoms and job absenteeism during the first 6 months after initiation of DVT treatment compared to standard treatment alone.The Catheter-directed Venous Thrombolysis (CaVenT) study was a multicenter open label, randomized controlled trial of patients ages 18 years to 75 years with a verified high proximal DVT, <21 days of symptoms, and no apparent bleeding risk. Patients were allocated to additional CDT or to standard treatment only. Symptoms were assessed at baseline and at 6 months using items from the generic and disease-specific quality of life questionnaires EQ-5D and VEINES-QOL/Sym, respectively. Individual data on sickness benefits related to venous thromboembolic disease were obtained from the national welfare service.A total of 90 patients allocated additional CDT and 99 control patients completed long-term follow-up and were included in the analyses. Twenty-four in the CDT arm and 40 controls received sick leave (P = 0.046). When considering working patients only (54 in the CDT arm and 72 controls) this difference was no longer statistically significant. Mean duration of job absenteeism was 86.4 days (95% confidence interval 59.4-113.5) in the CDT arm and 60.1 days (95% confidence interval 42.3-77.8) in controls (P = 0.072). After 6 months, more controls experienced frequent swelling of the leg compared with those allocated to CDT (47 [49.0%] patients versus 25 [29.4%] patients, respectively, [P = 0.007]).There are limitations to our data, but the findings indicate improved symptom relief and less frequent job absenteeism in patients treated with additional CDT; this expands upon previously established benefits from this treatment.

Dataset Information

Non-Invasive Thrombolysis Using Microtripsy in a Porcine Deep Vein Thrombosis Model.

Publications

Non-Invasive Thrombolysis Using Microtripsy in a Porcine Deep Vein Thrombosis Model.

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