Clinical Outcomes of Arteriovenous Fistula Treatment Using the Penumbra SMART COIL System: A Subgroup Analysis from the Multicenter SMART Registry.

BACKGROUND: Endovascular embolization procedures are typically the primary treatment modality for arteriovenous fistula (AVF). The objective of this subset analysis was to evaluate the prospective long-term clinical outcomes of AVF patients treated with the SMART COIL System. METHODS: Patients who had arteriovenous fistulas (AVF) and underwent endovascular coiling using the Penumbra SMART COIL system were part of a subset analysis within the SMART registry. The SMART registry is a post-market registry that is prospective, multicenter, and single-arm in design. After the treatment, these patients were monitored for a period of 12 ± 6 months. RESULTS: A total of 41 patients were included. No patients (0/41) had a procedural device-related serious adverse event (SAE). Re-access involving a guidewire due to catheter kickout was unnecessary for 85.4% (35/41) of the patients. Complete occlusion after the procedure was achieved in 87.8% (36/41) of patients. The periprocedural SAE rate was 2.4% (1/41), and no periprocedural deaths occurred (0/41). During the follow-up period, there were instances of re-treatment in 3.4% (1/29) of patients. At one year, the lesion occlusion was better or stable in 93.3% (28/30) of patients. The rate of serious adverse events (SAE) from 24 hours to 1 year (±6 months) following the procedure was 26.8% (11/41). The one-year all-cause mortality rate stood at 2.4% (1/ 41), and at the one-year follow-up, 90.9% (20/22) of patients had a modified Rankin Scale score within the range of 0 to 2. CONCLUSION: The coiling procedure for arteriovenous fistulas using the SMART COIL System proved to be safe and effective at the one-year follow-up.

First multicenter study evaluating the utility of the BENCHMARKTM BMXTM 81 large-bore access catheter in neurovascular interventions.

INTRODUCTION: This study is the first multicentric report on the safety, efficacy, and technical performance of utilizing a large bore (0.081″ inner diameter) access catheter in neurovascular interventions. METHODS: Data were retrospectively collected from seven sites in the United States for neurovascular procedures via large bore 0.081″ inner diameter access catheter (Benchmark BMX81, Penumbra, Inc.). The primary outcome was technical success, defined as the access catheter reaching its target vessel. Safety outcomes included periprocedural device-related and access site complications. RESULTS: There were 90 consecutive patients included. The median age of the patients was 63 years (IQR: 53, 68); 53% were female. The most common interventions were aneurysm embolization (33.3%), carotid stenting (12.2%), and arteriovenous malformation embolization (11.1%). The transradial approach was most used (56.7%), followed by transfemoral (41.1%). Challenging anatomic variations included severe vessel tortuosity (8/90, 8.9%), type 2 aortic arch (7/90, 7.8%), type 3 aortic arch (2/90, 2.2%), bovine arch (2/90, 2.2%), and severe angle (<30°) between the subclavian artery and target vessel (1/90, 1.1%). Technical success was achieved in 98.9% of the cases (89/90), with six cases requiring a switch from radial to femoral (6.7%) and one case from femoral to radial (1.1%). There were no access site complications or complications related to the 0.081″ catheter. Two postprocedural complications occurred (2.2%), unrelated to the access catheter. CONCLUSION: The BMX™ 81 large-bore access catheters was safe and effective in both radial and femoral access across a wide range of neurovascular procedures, achieving high technical success without any access site or device-related complications.

Comparison of aspiration catheter performance using adaptive pulsatile aspiration in an in vitro thrombectomy model.

OBJECTIVE: Aspiration with a pump or syringe is a mainstay of mechanical thrombectomy (MT) for acute ischemic stroke (AIS), but this technology has seen minimal evolution. Non-continuous adaptive pulsatile aspiration (APA) has been proposed as a potential alternative to standard continuous aspiration as a means of improving revascularization efficiency. METHODS: Using a pathophysiological flow bench model with a synthetic clot, we performed in vitro thrombectomies using the ALGO® Von Vascular, Inc. (Sunrise, FL) APA pump. A total of 25 FDA-approved aspiration catheters were tested, representing inner diameters (ID) from 0.035 in. to 0.088 in. The pump was used in 30 trials with each catheter to remove a simulated M1 occlusion. Revascularization, clot ingestion, time to clot removal, and distal embolization were measured. RESULTS: Among catheters tested using APA, first-pass TICI 3 revascularization was achieved in 100% of the 750 thrombectomy trials using 25 different catheters. There were no distal emboli detected in any trial run. Complete clot ingestion into the pump collection chamber was achieved in 87% to 100% of trials (overall 95%) with clot in the remaining trials corking within the catheter and removed from the model. Time from clot contact to clot removal ranged from 11 s to 90 s (mean 22.6 s, SD 16.8 s), which was negatively correlated with catheter ID (p = 0.007). CONCLUSION: APA via the Von Vascular, Inc. ALGO® pump achieved a high success rate in an in vitro MT model. All catheters tested with the pump achieved complete reperfusion in all trials, and complete clot ingestion into the pump was seen in a majority of trials. The promising in vitro performance of APA using multiple catheters warrants future in vivo investigation.