BACKGROUND: The use of shunting in carotid endarterectomy (CEA) is controversial. This randomized trial compared the results of routine (RS) vs selective shunting (SS) based on stump pressure (SP). METHODS:Two-hundred CEA patients under general anesthesia were randomized into RS (98 patients) or SS (102 patients), where shunting was used only if systolic SP (SSP) was <40 mm Hg. Clinical and demographic characteristics were comparable in both groups. Patients underwent immediate and 30-day postoperative duplex ultrasound follow-up. Analysis was by intention-to-treat. RESULTS: Of 102 SS patients, 29 (28%) received shunting. Indications for CEA were similar (42% symptomatic for RS; 47% for SS, P = .458). The mean internal carotid artery diameter was comparable (5.5 vs 5.5 mm, P = .685). Mean preoperative ipsilateral and contralateral stenosis was 76% and 38% for RS (P = .268) vs 78% and 40% for SS (P = .528). Mean preoperative ipsilateral and contralateral stenosis was 79% and 56% in the shunted (P = .634) vs 78% and 34% in the nonshunted subgroup of SS patients (P = .002). The mean SSP was 55.9 mm Hg in RS vs 56.2 for SS (P = .915). The mean SSP was 33 mm Hg in the shunted vs 65 in the nonshunted subgroup (P < .0001). Mean clamp time in the nonshunted subgroup of SS was 32 minutes. Mean shunt time was 35 minutes in RS and 33 in SS (P = .354). Mean operative time was 113 minutes for RS and 109 for SS (P = .252), and 111 minutes in shunted and 108 in the nonshunted subgroup (P = .586). Mean arteriotomy length was 4.4 cm for RS and 4.2 for SS (P = .213). Perioperative stroke rate was 0% for RS vs 2% for SS (one major and one minor stroke, both related to carotid thrombosis; P = .498). No patients died perioperatively. Combined perioperative transient ischemic attack (TIA) and stroke rates were 2% in RS vs 2.9% in SS (P > .99). The overall perioperative complication rates were 8.3% in RS (2 TIA, 3 hemorrhage, 1 myocardial infarction [MI], and 1 asymptomatic carotid thrombosis) vs 7.8% in SS (2 strokes, 1 TIA, 3 hemorrhage, 1 MI, and 1 congestive heart failure; P = .917). CONCLUSIONS: RS and SS were associated with a low stroke rate. Both methods are acceptable, and surgeons should select the method with which they are more comfortable. Copyright (c) 2010 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.
RCT Entities:
BACKGROUND: The use of shunting in carotid endarterectomy (CEA) is controversial. This randomized trial compared the results of routine (RS) vs selective shunting (SS) based on stump pressure (SP). METHODS: Two-hundred CEA patients under general anesthesia were randomized into RS (98 patients) or SS (102 patients), where shunting was used only if systolic SP (SSP) was <40 mm Hg. Clinical and demographic characteristics were comparable in both groups. Patients underwent immediate and 30-day postoperative duplex ultrasound follow-up. Analysis was by intention-to-treat. RESULTS: Of 102 SSpatients, 29 (28%) received shunting. Indications for CEA were similar (42% symptomatic for RS; 47% for SS, P = .458). The mean internal carotid artery diameter was comparable (5.5 vs 5.5 mm, P = .685). Mean preoperative ipsilateral and contralateral stenosis was 76% and 38% for RS (P = .268) vs 78% and 40% for SS (P = .528). Mean preoperative ipsilateral and contralateral stenosis was 79% and 56% in the shunted (P = .634) vs 78% and 34% in the nonshunted subgroup of SSpatients (P = .002). The mean SSP was 55.9 mm Hg in RS vs 56.2 for SS (P = .915). The mean SSP was 33 mm Hg in the shunted vs 65 in the nonshunted subgroup (P < .0001). Mean clamp time in the nonshunted subgroup of SS was 32 minutes. Mean shunt time was 35 minutes in RS and 33 in SS (P = .354). Mean operative time was 113 minutes for RS and 109 for SS (P = .252), and 111 minutes in shunted and 108 in the nonshunted subgroup (P = .586). Mean arteriotomy length was 4.4 cm for RS and 4.2 for SS (P = .213). Perioperative stroke rate was 0% for RS vs 2% for SS (one major and one minor stroke, both related to carotid thrombosis; P = .498). No patients died perioperatively. Combined perioperative transient ischemic attack (TIA) and stroke rates were 2% in RS vs 2.9% in SS (P > .99). The overall perioperative complication rates were 8.3% in RS (2 TIA, 3 hemorrhage, 1 myocardial infarction [MI], and 1 asymptomatic carotid thrombosis) vs 7.8% in SS (2 strokes, 1 TIA, 3 hemorrhage, 1 MI, and 1 congestive heart failure; P = .917). CONCLUSIONS: RS and SS were associated with a low stroke rate. Both methods are acceptable, and surgeons should select the method with which they are more comfortable. Copyright (c) 2010 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.
Authors: Philip P Goodney; Jessica B Wallaert; Salvatore T Scali; David H Stone; Virendra Patel; Palma Shaw; Brian W Nolan; Jack L Cronenwett Journal: J Vasc Surg Date: 2011-11-03 Impact factor: 4.268