Health Problem: Venous thromboembolism (VTE) occurs when a blood clot blocks blood circulation and pulmonary embolism (PE) occurs when a blood clot dislodges and travels into pulmonary circulation. PE causes serious morbidity and mortality, with a 1-month mortality rate of 12%.

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 PE:

  • Are PMT and UAT effective for eliminating thromboses and emboli, restoring blood flow and vascular function, and preventing damage to tissues and organs?

  • Are PMT and UAT devices safe?

  • How do PMT and UAT devices compare with other standard treatments for thromboses and emboli?

  • Have definitive patient selection criteria been established for PMT and UAT for PE?

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