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Rotational atherectomy with a new device: initial clinical experience
O Kjellgren1, A Motarjeme, S Feld
1Department of Internal Medicine, University of Texas Medical School, Houston 77030, USA.
Catheterization and Cardiovascular Diagnosis
|April 1, 1996
Summary
The Bard Atherectomy Catheter effectively treats peripheral artery disease, improving blood flow and patient symptoms. This rotational atherectomy device shows promise for small and medium vessels.
Area of Science:
- Cardiovascular Interventions
- Medical Devices
- Peripheral Artery Disease
Background:
- Peripheral artery disease (PAD) significantly impacts limb salvage and quality of life.
- Existing atherectomy devices have limitations in efficacy and vessel size applicability.
Purpose of the Study:
- To evaluate the initial clinical experience and safety of the Bard Atherectomy Catheter.
- To assess the device's effectiveness in treating peripheral arterial lesions.
Main Methods:
- Initial clinical experience with the Bard Atherectomy Catheter in 10 patients with 20 peripheral lesions.
- Rotational atherectomy at 1,500 RPM followed by adjunctive balloon angioplasty.
Main Results:
- Successful atherectomy and angioplasty in all 20 lesions, achieving <50% stenosis in 100% post-angioplasty.
- Significant lumen diameter improvement from 0.8 mm to 3.9 mm (P < 0.001).
- Initial symptom improvement in all patients; 80% showed persistent improvement at 6 months.
Conclusions:
- The Bard Atherectomy Catheter is a valuable new tool for atherectomy in small- and medium-sized peripheral vessels.
- The device demonstrates safety and efficacy in improving lumen diameter and patient symptoms.
- Further investigation is warranted for its use in coronary arteries.