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Vacuum-assisted thrombectomy system effective for treating peripheral, visceral arterial occlusions
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HOLLYWOOD, Fla. — A vacuum-assisted thrombectomy system is safe and effective for treatment of patients with peripheral or visceral arterial occlusions, according to interim results of the PRISM registry.
The multicenter PRISM study is designed to assess the safety and efficacy of the Indigo system (Penumbra) in a variety of clinical applications and to determine the optimal technique and implementation of the system, including how it works with and without adjunctive lytic therapy, James F. Benenati, MD, from Miami Cardiac and Vascular Institute, said during the International Symposium on Endovascular Therapy.
The system may be an improvement on current interventions for such occlusions, which “are often associated with incomplete revascularization, serious bleeding complications, long treatment times and morbidity,” he said.
The vacuum-based aspiration system, designed for recovery of thrombi and emboli in small and medium vessels, is modeled after devices that have successfully treated acute ischemic stroke, Benenati said. The procedure usually takes less than 30 minutes.
Benenati and colleagues enrolled 83 patients (90% with lower-extremity occlusions) in the retrospective, single-arm registry. The primary outcome was TIMI flow. Most patients had TIMI 0 or 1 flow at baseline.
The system achieved revascularization to TIMI 2 or 3 flow in 96.3% of patients; in 87.8% of cases, this was achieved without any adjunctive therapies, Benenati said.
Use of the system was effective in a variety of clinical scenarios, including treatment of intra-procedural emboli, acute ischemia, patients who had failed thrombolysis and patients who received the system as a frontline therapy, he said.
No serious device-related adverse events were reported.
“We have enough information to suggest that this is a viable option,” Benenati said. “This is a safe and effective device. Improvement in TIMI scores supports the use of this system for a wide range of applications.”
Benenati noted that there is a learning curve. “It is not particularly steep, but one issue we to have to be aware of is blood loss. Based on this registry, we have evidence to perform further prospective trials to validate this information.” – by Erik Swain
Reference:
Benenati JF, et al. Concurrent Session I: Peer-Reviewed Abstracts. Presented at: International Symposium on Endovascular Therapy; Feb. 6-10, 2016; Hollywood, Fla.
Disclosure: Benenati reports speaking for and receiving a royalty from Penumbra.