Health Problem: Venous thromboembolism (VTE) occurs when a blood clot blocks blood circulation. Deep vein thrombosis (DVT) is a blood clot that forms in a deep vein, usually the leg or pelvis, although sometimes in the arm. DVT causes serious morbidity and mortality, with a 1-month mortality rate of 6%.

Technology Description: Percutaneous mechanical thrombectomy (PMT) and ultrasound-assisted thrombolysis (UAT) involve the mechanical or ultrasound-facilitated removal of a thrombus or embolism from the venous system using percutaneous access. PMT and UAT devices utilize various mechanisms to disrupt and remove thromboembolisms, including rheolytic, rotational, and ultrasound-assisted systems. PMT and UAT are often used in concert with local application of thrombolytic drugs.

Controversy: PMT and UAT may pose benefits for treatment of VTE, particularly in more severe cases requiring immediate intervention, and when anticoagulation alone has failed or is contraindicated. However, the technology is invasive and relatively new, warranting assessment of effectiveness, safety, and the performance of the different commercially available devices.

Key Questions:

For adult patients with DVT:

  • Are PMT or UAT effective for eliminating thromboses and restoring blood flow and vascular function?
  • Are PMT and UAT devices safe for DVT, including for bleeding and pulmonary embolism (PE)?
  • How do PMT and UAT devices compare with other treatments for DVT?
  • Have definitive patient selection criteria been established for PMT or UAT for treatment of DVT?

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