OBJECTIVES: To investigate the in vivo haemodynamic performance and neurological outcome of two types of carotid shunt. DESIGN: Randomised single surgeon study of consecutive symptomatic patients. SETTING:163 consecutive patients undergoingcarotid endarterectomyfor symptomatic carotid disease were randomised to the Javid or Pruitt shunt. CHIEF OUTCOME MEASURES: Middle cerebral artery velocity (MCAV), preoperatively, during clamping, during shunting and post-restoration of flow, embolic episodes, neurological outcome. MAIN RESULTS: The MCAV preoperatively, at carotid clamping, and postoperatively was the same for both groups (p > 0.15). During shunting the MCAV was significantly lower in the Pruitt group, p < 0.005, 59% of the Javid and 34% of the Pruitt shunts maintained MCAV at preoperative levels p < 0.005, chi 2 = 8.92. The Javid shunt produced significantly more emboli (73% of cases) at declamping than the Pruitt (41%), p < 0.0002, chi 2 = 14.7. Four Javid patients and one Pruitt had disabling thromboembolic strokes; overall thromboembolic stroke rate 3.7%. The difference in stroke rates was not statistically significant (p = 0.14). CONCLUSIONS: The Pruitt shunt was unable to maintain preoperative MCAV in 66% of cases, the Javid shunt had a higher incidence of emboli on declamping. These factors may lead to an increased risk of stroke; however, the numbers required for statistical confirmation would be large.
RCT Entities:
OBJECTIVES: To investigate the in vivo haemodynamic performance and neurological outcome of two types of carotid shunt. DESIGN: Randomised single surgeon study of consecutive symptomatic patients. SETTING: 163 consecutive patients undergoing carotid endarterectomy for symptomatic carotid disease were randomised to the Javid or Pruitt shunt. CHIEF OUTCOME MEASURES: Middle cerebral artery velocity (MCAV), preoperatively, during clamping, during shunting and post-restoration of flow, embolic episodes, neurological outcome. MAIN RESULTS: The MCAV preoperatively, at carotid clamping, and postoperatively was the same for both groups (p > 0.15). During shunting the MCAV was significantly lower in the Pruitt group, p < 0.005, 59% of the Javid and 34% of the Pruitt shunts maintained MCAV at preoperative levels p < 0.005, chi 2 = 8.92. The Javid shunt produced significantly more emboli (73% of cases) at declamping than the Pruitt (41%), p < 0.0002, chi 2 = 14.7. Four Javid patients and one Pruitt had disabling thromboembolic strokes; overall thromboembolic stroke rate 3.7%. The difference in stroke rates was not statistically significant (p = 0.14). CONCLUSIONS: The Pruitt shunt was unable to maintain preoperative MCAV in 66% of cases, the Javid shunt had a higher incidence of emboli on declamping. These factors may lead to an increased risk of stroke; however, the numbers required for statistical confirmation would be large.