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PRISM: Aspiration technique safe, effective for removing peripheral, vascular arterial occlusions
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CHICAGO — An aspiration technique designed for removal of thrombi and emboli in the arterial system was safe and effective as front-line therapy for removal of peripheral and vascular arterial occlusions or after failed thrombolysis or thrombectomy, according to results from the PRISM study.
George Adams, MD, MHS, FACC, FSCAI, from the UNC Rex Hospital in Raleigh, North Carolina, presented the data at AMP: The Amputation Prevention Symposium.
The PRISM study was a multicenter, retrospective analysis of 79 patients (mean age, 69 years; 42% women) treated with a power aspiration-based extraction technique (Xtract) using the Indigo Aspiration System (Penumbra). To qualify for inclusion, patients had to have evidence of visceral arterial or peripheral occlusion (TIMI risk score, 0-1), and indications for treatment included failed thrombolysis, acute limb ischemia or distal emboli from preceding intervention.
At baseline, the researchers found high rates of peripheral vascular disease (86.1%), hypertension (82.9%), smoking (74.3%) and dyslipidemia (69.7%). Additionally, 33.3% had diabetes and 37.3% had CAD. Although the locations of target vessels were varied, the majority were popliteal, superficial femoral or below-the-knee, Adams noted.
The device was used as front line in 49.4% of patients, after thrombolytics in 15.2%, after other mechanical therapy in 19% and after both thrombolytics and mechanical therapy in 16.5%.
Treatment with the device appeared to be highly effective, according to Adams.
Among those who received front-line treatment with the device, 79.5% were TIMI 2 or 3 after treatment with the Indigo system and 94.9% were TIMI 2 or 3 after all interventions. Among those who underwent thrombolytic therapy first, 91.7% were TIMI 2 or 3 after treatment with the device, with no change after all interventions. Among those who received mechanical thrombectomy first, 92.9% were TIMI 2 or 3 after treatment with the device and 100% of patients were TIMI 2 or 3 after all interventions. Similarly, all patients who received thrombolysis and mechanical therapies first were TIMI 2 of 3 after treatment with the device and all patients were TIMI 2 or 3 after all interventions.
Additionally, among all patients, 87.2% were TIMI 2 or 3 after treatment with the device and 96.2% were TIMI 2 or 3 after all interventions. Moreover, TIMI 3 was achieved in 77.2% after all interventions.
The median procedure time from puncture to aspiration was 67.5 minutes.
The device was also deemed safe, with 8.9% of patients experiencing procedure-related adverse events within 24 hours and no patients experiencing device-related events.
“The Xtract technique is atraumatic, versatile, safe and effective at removing peripheral vascular arterial occlusion. It’s effective as a front-line treatment and after failed thrombolysis or thrombectomy, with no device-related side effects,” Adams said during his presentation. “The device has other applications, including emboli after prior interventions, acute ischemia, failed thrombolysis and as front-line therapy.” – by Melissa Foster
Reference:
Adams G. General sessions 4: Aortic iliac and below: Where do we stand? Presented at: AMP: The Amputation Prevention Symposium; Aug. 9-12, 2017; Chicago.
Disclosure: Adams reports being a consultant for, receiving research support from and/or being a speaking representative for Abbott Vascular, Asah Intecc, Bard, Boston Scientific, Cardinal-Cordis, Cook Medical, CloSys, Cardiovascular Systems Inc., Daiichi Sankyo, Gore, Intact Vascular, Lake Region Medical, Medtronic, Mercator Medsystems, Penumbra, Philips-Volcano, Roxwood Medical, Shockwave Medical, Spectranetics and Terumo.