Superiority of Transcutaneous Oxygen Tension Measurements in Predicting Limb Salvage After Below-the-Knee Angioplasty: A Prospective Trial in Diabetic Patients With Critical Limb Ischemia

Redlich, Ulf; Xiong, Yan; Pech, Maciej; Tautenhahn, J.; Halloul, Z.; Lobmann, Ralf; Adolf, Daniela; Ricke, Jens; Dudeck, Oliver

doi:10.1007/s00270-010-9968-x

Cited by 26 publications

(20 citation statements)

References 28 publications

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“…Redlich et al reported that TcPO 2 was a valid predictor for limb salvage in diabetic patients with CLI after infrapopliteal PTA, even when angiographic outcome criteria failed and that ABI measurement was of no prognostic value [33].…”

Section: Discussionmentioning

confidence: 98%

Comparison of the effect of stem cell therapy and percutaneous transluminal angioplasty on diabetic foot disease in patients with critical limb ischemia

et al. 2014

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Section: Discussionmentioning

confidence: 98%

Comparison of the effect of stem cell therapy and percutaneous transluminal angioplasty on diabetic foot disease in patients with critical limb ischemia

et al. 2014

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“…4,5 Indeed, although vessel patency alone cannot match patient-centered clinical end points 6 and any endovascular program has to be integrated into a network-based system of care involving different professionals, 7,8 an increased cutaneous oxygen pressure resulting from successful revascularization promotes infection clearance and ulcer granulation at a crucial time point. 9 The efficacy of percutaneous transluminal angioplasty (PTA) with conventional balloons, however, is limited by the high 12-month restenosis and target lesion revascularization (TLR) rates. 10 Loss of vessel patency affects the healing process, resulting in no healing, decrease-increase behavior of the ulcer, or appearance of new foot lesions.…”

Section: Clinical Perspective On P 621mentioning

confidence: 99%

Drug-Eluting Balloon in Peripheral Intervention for Below the Knee Angioplasty Evaluation (DEBATE-BTK)

et al. 2013

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Background-The 1-year restenosis rate after balloon angioplasty of long lesions in below-the-knee arteries may be as high as 70%. Our aim was to investigate the efficacy of a paclitaxel drug-eluting balloons versus conventional percutaneous transluminal angioplasty (PTA) for the reduction of restenosis in diabetic patients with critical limb ischemia undergoing endovascular intervention of below-the-knee arteries. Methods and Results-The Drug-Eluting Balloon in Peripheral Intervention for Below the Knee Angioplasty Evaluation(DEBATE-BTK) is a randomized, open-label, single-center study comparing drug-eluting balloons and PTA. Inclusion criteria were diabetes mellitus, critical limb ischemia (Rutherford class 4 or higher), significant stenosis or occlusion >40 mm of at least 1 below-the-knee vessel with distal runoff, and life expectancy >1 year. Binary in-segment restenosis at a 1-year angiographic or ultrasonographic follow-up was the primary end point. Clinically driven target lesion revascularization, major amputation, and target vessel occlusion were the secondary end points. One hundred thirty-two patients with 158 infrapopliteal atherosclerotic lesions were enrolled. Mean length of the treated segments was 129±83 mm in the drugeluting balloon group compared with 131±79 mm in the PTA group (P=0.7). Binary restenosis, assessed by angiography in >90% of patients, occurred in 20 of 74 lesions (27%) in the drug-eluting balloon group compared with 55 of 74 lesions (74%) in the PTA group (P<0.001); target lesion revascularization, in 12 (18%) versus 29 (43%; P=0.002); and target vessel occlusion, in 12 (17%) versus 41 (55%; P<0.001). Only 1 major amputation occurred, in the PTA group (P=0.9). Conclusions-Drug-eluting balloons compared with PTA strikingly reduce 1-year restenosis, target lesion revascularization, and target vessel occlusion in the treatment of below-the-knee lesions in diabetic patients with critical limb ischemia. Clinical Trial Registration-URL: http://ClinicalTrials.gov. Unique identifier: NCT01558505. Received February 6, 2013; accepted June 12, 2013. From the Cardiovascular and Neurological Department (F.L., I.P., P.A., S.G., K.D., G.F., G.V., F.T., G.B., L.B.) and Diabetes Unit (L.R.), San Donato Hospital, Arezzo, Italy; and Department of Cardiovascular Diseases, University of Siena, Le Scotte Hospital, Siena, Italy (S.G.).Correspondence to Francesco Liistro, MD, Cardiovascular and Neurological Department, San Donato Hospital, Via Pietro Nenni 20, 52100, Arezzo, Italy. E-mail francescoliistro@hotmail.com We designed a prospective, randomized trial to compare the performance of a novel DEB (IN.PACT Amphirion, Medtronic, Santa Rosa, CA) with conventional PTA in diabetics with de novo, long atherosclerotic lesions of the BTK area using 1-year binary restenosis rate as the primary end point. Drug-Eluting Balloon in Peripheral Intervention for Below the Knee Angioplasty Evaluation (DEBATE-BTK) A Randomized Trial in Diabetic Patients With Critical Limb Ischemia Methods Study DesignThe Drug-Eluting...

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“…6 In our hospital, non-invasive tests (pain in the lower limb, Doppler, ABI and TcPO 2 ) are performed by the nursing department in the Vascular Radiology Service, and our results are consistent with the progression of our professional activity. 4,7 We have observed that ABI cannot be determined in some cases (2.5%) or is unreliable when there is a calcified arterial medial layer (12.5% of cases), showing limitations in outcomes of success in PTA-treated patients (15% of total). 4,6,7 In this study, we monitored TcPO 2 while performing PTA revealing variations in each phase of the radiological procedure.…”

Section: Discussionmentioning

confidence: 95%

“…4,7 We have observed that ABI cannot be determined in some cases (2.5%) or is unreliable when there is a calcified arterial medial layer (12.5% of cases), showing limitations in outcomes of success in PTA-treated patients (15% of total). 4,6,7 In this study, we monitored TcPO 2 while performing PTA revealing variations in each phase of the radiological procedure. We have not found previous references for this observation except that by Wagner et al 6 that described similar changes in only one patient.…”

Section: Discussionmentioning

confidence: 95%

Transcutaneous oxygen tension measurements following peripheral transluminal angioplasty procedure has more specificity and sensitivity than ankle brachial index

Pardo¹,

Baños²,

Bernal³

et al. 2015

BJR

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Superiority of Transcutaneous Oxygen Tension Measurements in Predicting Limb Salvage After Below-the-Knee Angioplasty: A Prospective Trial in Diabetic Patients With Critical Limb Ischemia

Abstract: Below-the-knee PTA as an isolated part of therapy was effective to prevent major amputation in more than a half of diabetic patients with CLI. TcPO₂ was a valid predictor for limb salvage, even when angiographic outcome criteria failed.

Cited by 26 publications

References 28 publications

Comparison of the effect of stem cell therapy and percutaneous transluminal angioplasty on diabetic foot disease in patients with critical limb ischemia

Comparison of the effect of stem cell therapy and percutaneous transluminal angioplasty on diabetic foot disease in patients with critical limb ischemia

Drug-Eluting Balloon in Peripheral Intervention for Below the Knee Angioplasty Evaluation (DEBATE-BTK)

Transcutaneous oxygen tension measurements following peripheral transluminal angioplasty procedure has more specificity and sensitivity than ankle brachial index

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