Lars G Svensson1, Eugene H Blackstone2, Carolyn Apperson-Hansen3, Paul M Ruggieri4, Ponnuthurai Ainkaran5, Richard I Naugle6, Brian Lima7, Eric E Roselli8, Maxwell Cooper7, David Somogyi9, E Murat Tuzcu10, Samir Kapadia10, Daniel G Clair11, Joseph F Sabik8, Bruce W Lytle8. 1. Aortic Center, Cleveland Clinic, Cleveland, Ohio; Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio. Electronic address: svenssl@ccf.org. 2. Aortic Center, Cleveland Clinic, Cleveland, Ohio; Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio; Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio. 3. School of Medicine, Case Western Reserve University, Cleveland, Ohio. 4. Department of Neuroradiology, Cleveland Clinic, Cleveland, Ohio. 5. Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio. 6. Department of Psychiatry and Psychology, Cleveland Clinic, Cleveland, Ohio. 7. Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio. 8. Aortic Center, Cleveland Clinic, Cleveland, Ohio; Department of Thoracic and Cardiovascular Surgery, Cleveland Clinic, Cleveland, Ohio. 9. Department of Perfusion Services, Cleveland Clinic, Cleveland, Ohio. 10. Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio. 11. Aortic Center, Cleveland Clinic, Cleveland, Ohio; Department of Vascular Surgery, Cleveland Clinic, Cleveland, Ohio.
Abstract
OBJECTIVE: The study objective was to perform a randomized trial of brain protection during total aortic arch replacement and identify the best way to assess brain injury. METHODS:From June 2003 to January 2010, 121 evaluable patients were randomized to retrograde (n = 60) or antegrade (n = 61) brain perfusion during hypothermic circulatory arrest. We assessed the sensitivity of clinical neurologic evaluation, brain imaging, and neurocognitive testing performed preoperatively and 4 to 6 months postoperatively to detect brain injury. RESULTS: A total of 29 patients (24%) experienced neurologic events. Clinical stroke was evident in 1 patient (0.8%), and visual changes were evident in 2 patients; all had brain imaging changes. A total of 14 of 95 patients (15%) undergoing both preoperative and postoperative brain imaging had evidence of new white or gray matter changes; 10 of the 14 patients had neurocognitive testing, but only 2 patients experienced decline. A total of 17 of 96 patients (18%) undergoing both preoperative and postoperative neurocognitive testing manifested declines of 2 or more reliable change indexes; of these 17, 11 had neither imaging changes nor clinical events. Thirty-day mortality was 0.8% (1/121), with no neurologic deaths and a similar prevalence of neurologic events after retrograde and antegrade brain perfusion (22/60, 37% and 15/61, 25%, respectively; P = .2). CONCLUSIONS: Although this randomized clinical trial revealed similar neurologic outcomes after retrograde or antegrade brain perfusion for total aortic arch replacement, clinical examination for postprocedural neurologic events is insensitive, brain imaging detects more events, and neurocognitive testing detects even more. Future neurologic assessments for cardiovascular procedures should include not only clinical examination but also brain imaging studies, neurocognitive testing, and long-term assessment.
RCT Entities:
OBJECTIVE: The study objective was to perform a randomized trial of brain protection during total aortic arch replacement and identify the best way to assess brain injury. METHODS: From June 2003 to January 2010, 121 evaluable patients were randomized to retrograde (n = 60) or antegrade (n = 61) brain perfusion during hypothermic circulatory arrest. We assessed the sensitivity of clinical neurologic evaluation, brain imaging, and neurocognitive testing performed preoperatively and 4 to 6 months postoperatively to detect brain injury. RESULTS: A total of 29 patients (24%) experienced neurologic events. Clinical stroke was evident in 1 patient (0.8%), and visual changes were evident in 2 patients; all had brain imaging changes. A total of 14 of 95 patients (15%) undergoing both preoperative and postoperative brain imaging had evidence of new white or gray matter changes; 10 of the 14 patients had neurocognitive testing, but only 2 patients experienced decline. A total of 17 of 96 patients (18%) undergoing both preoperative and postoperative neurocognitive testing manifested declines of 2 or more reliable change indexes; of these 17, 11 had neither imaging changes nor clinical events. Thirty-day mortality was 0.8% (1/121), with no neurologic deaths and a similar prevalence of neurologic events after retrograde and antegrade brain perfusion (22/60, 37% and 15/61, 25%, respectively; P = .2). CONCLUSIONS: Although this randomized clinical trial revealed similar neurologic outcomes after retrograde or antegrade brain perfusion for total aortic arch replacement, clinical examination for postprocedural neurologic events is insensitive, brain imaging detects more events, and neurocognitive testing detects even more. Future neurologic assessments for cardiovascular procedures should include not only clinical examination but also brain imaging studies, neurocognitive testing, and long-term assessment.