Paul S Fishman1, W Jeffrey Elias2, Pejman Ghanouni3, Ryder Gwinn4, Nir Lipsman5, Michael Schwartz5, Jin W Chang6, Takaomi Taira7, Vibhor Krishna8, Ali Rezai8, Kazumichi Yamada9, Keiji Igase10, Rees Cosgrove11, Haruhiko Kashima12, Michael G Kaplitt13, Travis S Tierney11, Howard M Eisenberg1. 1. University of Maryland School of Medicine, Baltimore, Maryland, USA. 2. University of Virginia Health Sciences Center, Charlottesville, Virginia, USA. 3. Stanford University School of Medicine, Stanford, California, USA. 4. Swedish Neuroscience Institute, Seattle, Washington, USA. 5. Sunnybrook Health Sciences Center, Toronto, Ontario, Canada. 6. Yonsei University College of Medicine, Seoul, Korea. 7. Tokyo Women's Medical University, Tokyo, Japan. 8. Ohio State University Medical Center, Columbus, Ohio, USA. 9. Kumamoto University Hospital, Kumamoto and Hokuto Hospital, Obihiro City, Japan. 10. Washoukai Sadamoto Hospital, Matsuyama City, Japan. 11. Brigham and Women's Hospital, Boston, Massachusetts, USA. 12. Osaka University Hospital, Osaka, Japan. 13. Weil Cornell School of Medicine, New York, New York, USA.
Abstract
BACKGROUND: Magnetic resonance imaging-guided focused ultrasound thalamotomy is approved by the U.S. Food and Drug Administration for treatment of essential tremor. Although this incisionless technology creates an ablative lesion, it potentially avoids serious complications of open stereotactic surgery. OBJECTIVE: To determine the safety profile of magnetic resonance imaging-guided focused ultrasound unilateral thalamotomy for essential tremor, including frequency, and severity of adverse events, including serious adverse events. METHODS: Analysis of safety data for magnetic resonance imaging-guided focused ultrasound thalamotomy (186 patients, five studies). RESULTS: Procedure-related serious adverse events were very infrequent (1.6%), without intracerebral hemorrhages or infections. Adverse events were usually transient and were commonly rated as mild (79%) and rarely severe (1%). As previously reported, abnormalities in sensation and balance were the commonest thalamotomy-related adverse events. CONCLUSION: The overall safety profile of magnetic resonance imaging-guided focused ultrasound thalamotomy supports its role as a new option for patients with medically refractory essential tremor.
BACKGROUND: Magnetic resonance imaging-guided focused ultrasound thalamotomy is approved by the U.S. Food and Drug Administration for treatment of essential tremor. Although this incisionless technology creates an ablative lesion, it potentially avoids serious complications of open stereotactic surgery. OBJECTIVE: To determine the safety profile of magnetic resonance imaging-guided focused ultrasound unilateral thalamotomy for essential tremor, including frequency, and severity of adverse events, including serious adverse events. METHODS: Analysis of safety data for magnetic resonance imaging-guided focused ultrasound thalamotomy (186 patients, five studies). RESULTS: Procedure-related serious adverse events were very infrequent (1.6%), without intracerebral hemorrhages or infections. Adverse events were usually transient and were commonly rated as mild (79%) and rarely severe (1%). As previously reported, abnormalities in sensation and balance were the commonest thalamotomy-related adverse events. CONCLUSION: The overall safety profile of magnetic resonance imaging-guided focused ultrasound thalamotomy supports its role as a new option for patients with medically refractory essential tremor.
Authors: Jose A Pineda-Pardo; Raul Martínez-Fernández; Rafael Rodríguez-Rojas; Marta Del-Alamo; Frida Hernández; Guglielmo Foffani; Michele Dileone; Jorge U Máñez-Miró; Esther De Luis-Pastor; Lydia Vela; José A Obeso Journal: Hum Brain Mapp Date: 2019-03-13 Impact factor: 5.038
Authors: M Anthony Phipps; Sumeeth V Jonathan; Pai-Feng Yang; Vandiver Chaplin; Li Min Chen; William A Grissom; Charles F Caskey Journal: Sci Rep Date: 2019-11-07 Impact factor: 4.379