OBJECTIVE: Reperfusion of the limb after acute and persistent ischemia is associated with high rates of morbidity and mortality despite complete revascularization. Although reperfusion is a prerequisite for maintaining limb function, it may in itself cause further injury. There is experimental evidence that modification of the initial reperfusion modalities can minimize this reperfusion injury. We hypothesized that controlled reperfusion using a simple blood bag perfusion system reduces reperfusion injury and facilitates the return of normal function. METHODS:Fifteen consecutive patients (mean age, 80.5 +/- 5.0 years) with severe, acute lower-limb ischemia were allocated to two treatment arms in this prospective, controlled observational study. Group I (n = 8) underwent surgical embolectomy alone, and group II (n = 7) underwent surgical embolectomy plus controlled reperfusion using a simplified perfusion system. Indication for controlled reperfusion was made by the responsible surgeon. Controlled reperfusion consisted of a 30-minute infusion of a crystalloid reperfusion solution that was mixed with oxygenated blood (the blood:reperfusion solution ratio was 6:1) distal to the occlusion. Duration of ischemia, postoperative amputation rate, motor function of the ischemic limb, and pre- and postoperative serum creatine kinase levels were assessed. RESULTS: The duration of ischemia was 10.7 +/- 1.1 hours in group I and 19 +/- 5.2 hours in group II (P < .05). The site of the arterial occlusion was the iliac artery in nine patients and the common femoral artery in six patients. Full recovery was achieved in six of seven patients in group II and in only two of eight patients in group I (P < .05). There were three in-hospital deaths in group I, and two patients underwent major amputations. No in-hospital deaths or major amputations occurred in group II. CONCLUSION: The results from this preliminary study strongly suggest the hypothesis that the results of conventional embolectomy for acute, severe lower-limb ischemia can be improved by controlled reperfusion. To prove our preliminary findings, a large randomized, prospective, controlled, multicenter trial, the Controlled Reperfusion of the Acutely Ischemic Limb trial (CRAIL-Trial) is currently being conducted to prove our preliminary findings.
RCT Entities:
OBJECTIVE: Reperfusion of the limb after acute and persistent ischemia is associated with high rates of morbidity and mortality despite complete revascularization. Although reperfusion is a prerequisite for maintaining limb function, it may in itself cause further injury. There is experimental evidence that modification of the initial reperfusion modalities can minimize this reperfusion injury. We hypothesized that controlled reperfusion using a simple blood bag perfusion system reduces reperfusion injury and facilitates the return of normal function. METHODS: Fifteen consecutive patients (mean age, 80.5 +/- 5.0 years) with severe, acute lower-limb ischemia were allocated to two treatment arms in this prospective, controlled observational study. Group I (n = 8) underwent surgical embolectomy alone, and group II (n = 7) underwent surgical embolectomy plus controlled reperfusion using a simplified perfusion system. Indication for controlled reperfusion was made by the responsible surgeon. Controlled reperfusion consisted of a 30-minute infusion of a crystalloid reperfusion solution that was mixed with oxygenated blood (the blood:reperfusion solution ratio was 6:1) distal to the occlusion. Duration of ischemia, postoperative amputation rate, motor function of the ischemic limb, and pre- and postoperative serum creatine kinase levels were assessed. RESULTS: The duration of ischemia was 10.7 +/- 1.1 hours in group I and 19 +/- 5.2 hours in group II (P < .05). The site of the arterial occlusion was the iliac artery in nine patients and the common femoral artery in six patients. Full recovery was achieved in six of seven patients in group II and in only two of eight patients in group I (P < .05). There were three in-hospital deaths in group I, and two patients underwent major amputations. No in-hospital deaths or major amputations occurred in group II. CONCLUSION: The results from this preliminary study strongly suggest the hypothesis that the results of conventional embolectomy for acute, severe lower-limb ischemia can be improved by controlled reperfusion. To prove our preliminary findings, a large randomized, prospective, controlled, multicenter trial, the Controlled Reperfusion of the Acutely Ischemic Limb trial (CRAIL-Trial) is currently being conducted to prove our preliminary findings.
Authors: Robert S Crawford; Hassan Albadawi; Marvin D Atkins; John E Jones; Hyung-Jin Yoo; Mark F Conrad; W Gerald Austen; Michael T Watkins Journal: Surgery Date: 2010-02-04 Impact factor: 3.982
Authors: Murat Sezer; Javier Escaned; Christopher J Broyd; Berrin Umman; Zehra Bugra; Ilke Ozcan; Mehmet Rasih Sonsoz; Alp Ozcan; Adem Atici; Emre Aslanger; Z Irem Sezer; Justin E Davies; Niels van Royen; Sabahattin Umman Journal: J Am Heart Assoc Date: 2022-05-16 Impact factor: 6.106