Abstract
Abstract: :
Purpose: To evaluate the safety and potential efficacy of an electrically driven plasma mediated cutting device, the Pulsed Electron Avalanche Knife (PEAKTM), for specific surgical maneuvers associated with vitreoretinal dissection Methods: Patients aged 18 to 85, with proliferative diseases of the retina and vitreous associated with retinal detachment including diabetic retinopathy, proliferative vitreoretinopathy, and trauma, visual acuity 20/400 or less in the study eye and greater than or equal to 20/400 in the fellow eye, were eligible for inclusion. Four specific maneuvers were evaluated including 1. Transection of transvitreal membranes, 2. Dissection of fibroglial epiretinal membranes, 3. Dissection of fibrovascular epiretinal membranes, and 4. Retinotomy. The performance of the device, as well as the achievement of surgical goals, were evaluated in a prospective manner on standardized data collection forms. Institutional review board approval and patient informed consent were obtained in all cases. Results: As of November 2001, three patients were treated, two males, and one female, ranging in age from 32 to 59 years. Cutting occurred at rates of 0 to 30 Hz, with energy output ranging from 0.05 - 1.0 micro joules, selected by the surgeon using a specialized illuminated handpiece, console and footswitch. The mean number of pulses applied was 11,214 ranging from 3,007 to 15,885. The device was judged to have excellent ergonomic operating characteristics including fineness of cut, control, tissue distinction, illumination, and reliability. Compared with other optical based cutters including the erbium YAG endo probe, there appeared to be less ejection of debris, and fewer gas bubbles, and no signs of coagulation of adjacent tissue. One patient developed an iatrogenic retinal break associated with mild hemorrhage treated successfully with photocoagulation with no long-term sequela. Cumulative patient data as of February 2002 will be presented. Conclusion: The PEAKTM device is a novel and potentially useful tool for vitreoretinal dissection in humans with performance characteristics comparable or superior to, conventional mechanical and optical-based instrumentation. We present the first human experience with this device.
Keywords: 628 vitreoretinal surgery • 563 retinal detachment • 524 proliferative vitreoretinopathy