Effectiveness of Remote Ischaemic Conditioning in Critical Ischemia of the Digitals of Upper and Lower Limbs

N. Schahab, A. Aksoy, Schamim Schahab, M. Steinmetz, Christian Berg, C. Schaefer, G. Nickenig, V. Tiyerili
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Abstract

`Aim: The aim of our study was to determine the effectiveness and safety of remote ischaemic conditioning (RIC) in combination with i.v. prostavasin as a method of treatment for patients with peripheral acral vasculopathy, presenting as critical ischemia of the digitals of upper and lower limbs at the time of presentation with either surgical nor interventional treatment option Method: 33 patients were included in this non-randomized, prospective pilot-study with compassionate use. Primary endpoints were healing of ulcerations and amputation free time, secondary endpoint was safety of RIC. For the RIC, a blood flow reduction in the extremities was held in 2 cycles for over 5 minutes (20 mmHg over the systolic blood pressure) with 5 minutes reperfusion. During this time the medical agents were infused through a superficial vein into index extremity transvenously. The medication included: 2500 i.e., Heparin bolus, 5 μg PGE-1 in a 50 mL syringe with an isotonic solution. In cases where a vascular occlusion was seen in angiography additionally to PGE-1, 20 mg rt-PA was infused. Results: In 33 cases, transcutaneous oxygen partial pressure (TcPO2) levels increased significantly from 33 ± 16 mmHg to 48 ± 13 mmHg (p=0.0005) after the therapy compared to baseline. In 33 cases there was an improvement from 55 ± 27 mmHg to 73 ± 27 mmHg (p ≤ 0.004) in the acral arterial pressure measurement. 31 patients showed significantly better perfusion and vascularisation of the ischemic extremity after the therapy demonstrated in acral oscillography (31/94%) and angiography (6/18%). In 16 cases ulcerations (n=20) healed after 15 sessions of RIC. There was no need of any major or minor amputation in all patients. Conclusion: The presented RIC therapy proved to be an effective and safe treatment in addition to best medical treatment for patients with acute acral vascular disorder, especially in acute digital ischaemia, without a surgical or an interventional option.
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远端缺血调理治疗下肢和上肢严重缺血的疗效
目的:我们研究的目的是确定远程缺血调节(RIC)联合前列他伐辛静脉注射作为一种治疗外周肢端血管病变患者的有效性和安全性,这些患者在手术或介入治疗时表现为上肢和下肢手指严重缺血。方法:33名患者被纳入这项非随机的前瞻性试点研究。主要终点是溃疡愈合和截肢空闲时间,次要终点是RIC的安全性。对于RIC,在2个周期内保持四肢血流减少超过5分钟(比收缩压高20 mmHg),再灌注5分钟。在此期间,药物通过浅表静脉经静脉注入食指。药物包括:2500即肝素丸,5 μg PGE-1, 50ml注射器加等渗溶液。在血管造影中除PGE-1外还发现血管闭塞的病例中,输注20 mg rt-PA。结果:33例患者治疗后经皮氧分压(TcPO2)水平从33±16 mmHg显著升高至48±13 mmHg (p=0.0005)。33例患者的肢端动脉压由55±27 mmHg改善至73±27 mmHg (p≤0.004)。经肢端示波(31/94%)和血管造影(6/18%)检查,31例患者缺血肢体灌注和血管化明显改善。16例溃疡(n=20)在15次RIC治疗后愈合。所有患者均无需进行或大或小的截肢。结论:对于急性肢端血管紊乱患者,特别是急性指端缺血患者,在没有手术或介入选择的情况下,RIC治疗被证明是一种有效和安全的治疗方法,也是最佳的药物治疗方法。
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