BACKGROUND/AIMS: The RNS® System utilizes a cranially implanted neurostimulator attached to leads placed at the seizure focus to provide brain responsive stimulation for the treatment of medically intractable partial onset epilepsy. Infection and erosion rates related to the cranial implant site were assessed overall and by neurostimulator procedure to determine whether rates increased with additional procedures. METHODS: Infection and erosion rates were calculated as (1) chance per neurostimulator procedure, (2) incidence per patient implant year, and (3) rates for initial and each subsequent neurostimulator implant (generalized estimating equation). RESULTS: In 256 patients followed for an average of 7 years, the infection rate was 3.7% per neurostimulator procedure (n = 31/840), and the rate of erosions was 0.8% per neurostimulator procedure (n = 7/840). Rates did not increase with subsequent neurostimulator procedures (p = 0.66, infection; p = 0.70, erosion). A prior infection or erosion at the implant site did not significantly increase the risk at a later procedure (p ≥ 0.05 for all combinations). CONCLUSION: These data indicate that the risk for infection compares favorably to other neurostimulation devices and suggest that rates of infection and erosion do not increase with subsequent neurostimulator replacements.
BACKGROUND/AIMS: The RNS® System utilizes a cranially implanted neurostimulator attached to leads placed at the seizure focus to provide brain responsive stimulation for the treatment of medically intractable partial onset epilepsy. Infection and erosion rates related to the cranial implant site were assessed overall and by neurostimulator procedure to determine whether rates increased with additional procedures. METHODS:Infection and erosion rates were calculated as (1) chance per neurostimulator procedure, (2) incidence per patient implant year, and (3) rates for initial and each subsequent neurostimulator implant (generalized estimating equation). RESULTS: In 256 patients followed for an average of 7 years, the infection rate was 3.7% per neurostimulator procedure (n = 31/840), and the rate of erosions was 0.8% per neurostimulator procedure (n = 7/840). Rates did not increase with subsequent neurostimulator procedures (p = 0.66, infection; p = 0.70, erosion). A prior infection or erosion at the implant site did not significantly increase the risk at a later procedure (p ≥ 0.05 for all combinations). CONCLUSION: These data indicate that the risk for infection compares favorably to other neurostimulation devices and suggest that rates of infection and erosion do not increase with subsequent neurostimulator replacements.
Authors: Vicenta Salanova; Thomas Witt; Robert Worth; Thomas R Henry; Robert E Gross; Jules M Nazzaro; Douglas Labar; Michael R Sperling; Ashwini Sharan; Evan Sandok; Adrian Handforth; John M Stern; Steve Chung; Jaimie M Henderson; Jacqueline French; Gordon Baltuch; William E Rosenfeld; Paul Garcia; Nicholas M Barbaro; Nathan B Fountain; W Jeffrey Elias; Robert R Goodman; John R Pollard; Alexander I Tröster; Christopher P Irwin; Kristin Lambrecht; Nina Graves; Robert Fisher Journal: Neurology Date: 2015-02-06 Impact factor: 9.910
Authors: Frances M Weaver; Kenneth Follett; Matthew Stern; Kwan Hur; Crystal Harris; William J Marks; Johannes Rothlind; Oren Sagher; Domenic Reda; Claudia S Moy; Rajesh Pahwa; Kim Burchiel; Penelope Hogarth; Eugene C Lai; John E Duda; Kathryn Holloway; Ali Samii; Stacy Horn; Jeff Bronstein; Gatana Stoner; Jill Heemskerk; Grant D Huang Journal: JAMA Date: 2009-01-07 Impact factor: 56.272
Authors: Gregory K Bergey; Martha J Morrell; Eli M Mizrahi; Alica Goldman; David King-Stephens; Dileep Nair; Shraddha Srinivasan; Barbara Jobst; Robert E Gross; Donald C Shields; Gregory Barkley; Vicenta Salanova; Piotr Olejniczak; Andrew Cole; Sydney S Cash; Katherine Noe; Robert Wharen; Gregory Worrell; Anthony M Murro; Jonathan Edwards; Michael Duchowny; David Spencer; Michael Smith; Eric Geller; Ryder Gwinn; Christopher Skidmore; Stephan Eisenschenk; Michel Berg; Christianne Heck; Paul Van Ness; Nathan Fountain; Paul Rutecki; Andrew Massey; Cormac O'Donovan; Douglas Labar; Robert B Duckrow; Lawrence J Hirsch; Tracy Courtney; Felice T Sun; Cairn G Seale Journal: Neurology Date: 2015-01-23 Impact factor: 9.910
Authors: Christianne N Heck; David King-Stephens; Andrew D Massey; Dileep R Nair; Barbara C Jobst; Gregory L Barkley; Vicenta Salanova; Andrew J Cole; Michael C Smith; Ryder P Gwinn; Christopher Skidmore; Paul C Van Ness; Gregory K Bergey; Yong D Park; Ian Miller; Eric Geller; Paul A Rutecki; Richard Zimmerman; David C Spencer; Alica Goldman; Jonathan C Edwards; James W Leiphart; Robert E Wharen; James Fessler; Nathan B Fountain; Gregory A Worrell; Robert E Gross; Stephan Eisenschenk; Robert B Duckrow; Lawrence J Hirsch; Carl Bazil; Cormac A O'Donovan; Felice T Sun; Tracy A Courtney; Cairn G Seale; Martha J Morrell Journal: Epilepsia Date: 2014-02-22 Impact factor: 5.864
Authors: Dileep R Nair; Kenneth D Laxer; Peter B Weber; Anthony M Murro; Yong D Park; Gregory L Barkley; Brien J Smith; Ryder P Gwinn; Michael J Doherty; Katherine H Noe; Richard S Zimmerman; Gregory K Bergey; William S Anderson; Christianne Heck; Charles Y Liu; Ricky W Lee; Toni Sadler; Robert B Duckrow; Lawrence J Hirsch; Robert E Wharen; William Tatum; Shraddha Srinivasan; Guy M McKhann; Mark A Agostini; Andreas V Alexopoulos; Barbara C Jobst; David W Roberts; Vicenta Salanova; Thomas C Witt; Sydney S Cash; Andrew J Cole; Gregory A Worrell; Brian N Lundstrom; Jonathan C Edwards; Jonathan J Halford; David C Spencer; Lia Ernst; Christopher T Skidmore; Michael R Sperling; Ian Miller; Eric B Geller; Michel J Berg; A James Fessler; Paul Rutecki; Alica M Goldman; Eli M Mizrahi; Robert E Gross; Donald C Shields; Theodore H Schwartz; Douglas R Labar; Nathan B Fountain; W Jeff Elias; Piotr W Olejniczak; Nicole R Villemarette-Pittman; Stephan Eisenschenk; Steven N Roper; Jane G Boggs; Tracy A Courtney; Felice T Sun; Cairn G Seale; Kathy L Miller; Tara L Skarpaas; Martha J Morrell Journal: Neurology Date: 2020-07-20 Impact factor: 9.910