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Treatment of symptomatic peripheral atherosclerotic disease with a rotational atherectomy device
N M Zacca1, A E Raizner, G P Noon
1Department of Internal Medicine, Baylor College of Medicine, Houston, Texas.
Insights
The Squibb Rotablator effectively reduced arterial narrowings in patients, showing promising initial safety and feasibility. While symptomatically improving patients, long-term patency requires further investigation.
Area of Science:
- Vascular Surgery
- Interventional Cardiology
- Biomedical Engineering
Background:
- Significant arterial stenoses in iliac, superficial femoral, and popliteal arteries pose clinical challenges.
- Surgical bypass procedures are common but can be invasive.
Purpose of the Study:
- To evaluate the feasibility and safety of atherectomy using the Squibb Rotablator for treating peripheral arterial stenoses.
- To assess the effectiveness of the Rotablator in reducing arterial diameter and improving blood flow.
Main Methods:
- Atherectomy was performed on 6 patients with severe arterial narrowings (70-90%) using the Squibb Rotablator under angiographic guidance.
- The Rotablator device features a rotating burr with diamond blades.
- Effluent particles were analyzed for size, and animal studies were conducted to assess safety.
Main Results:
- Successful reduction of stenoses to ≤50% luminal diameter in all treated arteries (iliac, superficial femoral, popliteal).
- No significant complications were observed during the atherectomy procedures.
- Follow-up showed symptomatic improvement in all patients, though angiographic patency varied (37% at 5.2 months).
- Analysis of effluent particles indicated a predominance of smaller sizes (<8 microns), with larger particles decreasing with technique refinement.
- In vivo studies in pigs showed no acute adverse effects from injected effluent.
Conclusions:
- The Squibb Rotablator demonstrates promising feasibility and safety for atherectomy in peripheral arterial disease.
- While initial results are encouraging, long-term patency rates warrant further investigation and technique optimization.
- The device effectively reduces arterial stenosis, leading to symptomatic improvement in patients.
Abstract:
Narrowings 70 to 90% in diameter in 3 iliac, 4 superficial femoral and 2 popliteal arteries were crossed and atherectomized successfully in 6 patients using the Squibb Rotablator under angiographic guidance during surgical bypass procedures on these arteries. The Rotablator consists of a 1.25 to 4.5 mm diameter oblong burr with tiny diamond blades mounted on a flexible shaft, which tracks over a spring-tip guidewire and rotates at speeds greater than 120,000 rpm. All stenoses were reduced to less than or equal to 50% of the normal luminal diameter. No significant complications occurred. Of the 6 patients having the atherectomy procedure, 5 were reevaluated by duplex Doppler measurements 1.5 to 5.5 (mean 3.5) months after atherectomy and found to be patient with only mild residual flow disturbance. Repeat follow-up by angiography after a mean of 5.2 months, however, showed only 3 (37%) of the atherectomized segments in 3 patients to still be patent. All were symptomatically improved. Of the effluent particles analyzed, 90% were less than 8 microns in size, while only 5% reached 250 microns. With improvements in technique, the largest particles were 150 to 180 microns, constituting only 1.4% of effluent debris. Samples of the effluent from 2 patients were injected in vivo into the left coronary system of 2 pigs. There were no acute hemodynamic or electrocardiographic complications or pathologic evidence of muscle necrosis or vascular thrombosis 18 to 48 hours later. These preliminary results with respect to feasibility and safety of the Rotablator are promising.