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1.
Cochrane Database Syst Rev ; 7: CD015232, 2023 07 18.
Article in English | MEDLINE | ID: mdl-37462258

ABSTRACT

BACKGROUND: At least 7000 major lower limb amputations (MLLAs) are performed in the UK each year, 80% of which are due to peripheral arterial disease (PAD). Intraoperative blood loss can have a deleterious effect on patient outcomes, and its replacement with transfused blood is not without risk. Tourniquets can be used in lower limb surgical procedures to provide a bloodless surgical field, minimise intraoperative blood loss, and reduce perioperative blood transfusion requirements. Although their safety has been demonstrated in certain orthopaedic operations, their use among people with PAD undergoing MLLA remains controversial. Many clinicians are concerned about tourniquets potentially compromising perfusion of the stump and thereby impacting wound healing through direct tissue injury, damage to the arterial supply of the wound, or both. OBJECTIVES: To assess the safety and effectiveness of tourniquet use in people undergoing MLLA for complications of PAD, specifically with regard to intraoperative blood loss, change in haemoglobin levels, transfusion rates, wound healing, need for revision surgery, and postoperative complications including mortality. SEARCH METHODS: We searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase, and CINAHL databases and World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers from inception to 17 May 2022. SELECTION CRITERIA: We included randomised controlled trials (RCTs) comparing tourniquet use to no tourniquet use among people with PAD undergoing MLLA. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Primary outcomes were intraoperative blood loss, fall in haemoglobin levels, and perioperative blood transfusion requirement. Secondary outcomes were primary wound-healing rates, stump revision rates, other postoperative complications defined as per Clavien-Dindo classification, and postoperative mortality at 30 days and at maximal follow-up. We used GRADE to assess the certainty of evidence for each outcome. MAIN RESULTS: One RCT met our inclusion criteria, which was a prospective randomised blinded controlled trial conducted in Sheffield, UK in 2006. In total 64 participants undergoing transtibial amputation for non-reconstructable PAD were randomised to either tourniquet or no tourniquet to assess for intraoperative blood loss, fall in haemoglobin, transfusion requirement, wound healing, stump breakdown and revision. Ten participants were excluded postrandomisation (five from the tourniquet group and five from the no tourniquet group). The reported median volume of intraoperative blood loss was significantly less in the tourniquet group (255 mL (interquartile range (IQR) 150 to 572.5 mL))) compared to the control group (550 mL (IQR 255 to 1050 mL)) (P = 0.014). There was a significantly lower median drop in haemoglobin concentration in the tourniquet group (1.0 g/dL (IQR 0.6 to 2.4 g/dL)) compared to the control group (1.8 g/dL (IRQ 0 to 1.2 g/dL)) (P = 0.035). There was a significantly lower perioperative blood transfusion requirement in the tourniquet group (8 participants, 32%) compared to the control group (14 participants, 48%) (P = 0.047). There were no clear differences in wound breakdown, stump revision, primary wound healing at six weeks, postoperative complications (myocardial infarction, cardiac arrhythmias, pulmonary oedema), and death between groups. We assessed the one included study as at low risk of bias for sequence generation and blinding of outcome assessors; high risk of bias for incomplete outcome data and selective outcome reporting; and unclear risk of bias for allocation concealment, blinding of participants and personnel, and other sources of bias. We assessed the certainty of the evidence as low or very low due to risk of bias, small sample size, and the study being insufficiently powered for most outcomes. AUTHORS' CONCLUSIONS: This review identified only one small historical RCT evaluating tourniquet use in MLLA. Tourniquets appeared to reduce intraoperative blood loss, drop in haemoglobin, and blood transfusion requirements following transtibial amputations for people with PAD. However, it is unclear whether tourniquets affect wound healing, stump revision rates, postoperative complications, or mortality. High-certainty evidence is required to inform clinical decision-making for the use of tourniquets in these patients.


Subject(s)
Blood Loss, Surgical , Peripheral Arterial Disease , Humans , Blood Loss, Surgical/prevention & control , Peripheral Arterial Disease/surgery , Amputation, Surgical/adverse effects , Postoperative Complications/epidemiology , Lower Extremity/surgery , Randomized Controlled Trials as Topic
3.
4.
J Arthroplasty ; 31(9): 2004-7, 2016 09.
Article in English | MEDLINE | ID: mdl-27021701

ABSTRACT

BACKGROUND: Popliteal artery pseudoaneurysm is a rare complication after total knee arthroplasty. Early recognition is imperative in its management to prevent the subsequent development of compartment syndrome and soft tissue ischemia. The aim of this study was to evaluate the complication rate, recognition, and management of symptomatic popliteal artery pseudoaneurysm after total knee arthroplasty. METHODS: Between January 2004 and October 2014, 7937 consecutive total knee arthroplasties were identified from the Theatre Management (Ormis) System and cross-referenced against 1304 radiology reports containing the key words "popliteal" and "aneurysm' identified from the Patient Archiving Communication System. RESULTS: Seven patients (0.088%) were found to have had a symptomatic popliteal artery pseudoaneurysm. The median (range) interval between total knee arthroplasty and the radiological diagnosis of a pseudoaneurysm was 15 (7-27) days. Popliteal artery pseudoaneurysm was diagnosed on duplex imaging (n = 4), arteriogram (n = 2), and computed tomography angiogram (n = 1). Fasciotomies were undertaken in 3 patients. CONCLUSION: The complication rate of popliteal artery pseudoaneurysm was comparable to the literature. Recognition was identified as a problem. An appreciation of the mechanisms of injury and an awareness of this potential complication among orthopedic surgeons are imperative in reducing the complication rate and interval to diagnosis. Popliteal artery pseudoaneurysm should be included in the differential diagnosis for patients with a clinical presentation of postoperative compartment syndrome or deep vein thrombosis, and examination of the popliteal pulse should be undertaken early.


Subject(s)
Aneurysm, False/etiology , Arthroplasty, Replacement, Knee/adverse effects , Compartment Syndromes/surgery , Popliteal Artery/injuries , Aged , Aged, 80 and over , Computed Tomography Angiography , Female , Humans , Ischemia , Male , Middle Aged , Orthopedics , Postoperative Period , Radiography
5.
Cochrane Database Syst Rev ; (6): CD006767, 2014 Jun 24.
Article in English | MEDLINE | ID: mdl-24959692

ABSTRACT

BACKGROUND: Lower limb peripheral arterial disease (PAD) is a common, important manifestation of systemic atherosclerosis. Stenoses or occlusions in the superficial femoral artery may result in intermittent claudication or even critical ischaemia, which may be treated by balloon angioplasty with or without stenting. This is the first update of a review published in 2009. OBJECTIVES: The primary aim was to determine the effect of percutaneous transluminal angioplasty (PTA) compared with PTA with bare metal stenting for superficial femoral artery (SFA) stenoses on vessel patency in people with symptomatic (Rutherford categories1 to 6; Fontaine stages II to IV) lower limb peripheral vascular disease.In addition, we assessed the efficacy of PTA and stenting in improving quality of life, ankle brachial index and treadmill walking distance. SEARCH METHODS: For this update the Cochrane Peripheral Vascular Diseases Group Trials Search Co-ordinator searched the Specialised Register (last searched August 2013) and the Cochrane Central Register of Controlled Trials (CENTRAL) (2013, Issue 6). SELECTION CRITERIA: Randomised trials of angioplasty alone versus angioplasty with bare metal stenting for the treatment of superficial femoral artery stenoses. DATA COLLECTION AND ANALYSIS: Two review authors (MC, CT) independently selected suitable trials, assessed trial quality and extracted data. Furthermore, these two review authors performed assessments of methodological quality and wrote the final manuscript. The third review author (ADM) cross-checked all stages of the review process. MAIN RESULTS: We include three new studies in this update, making a total of 11 included trials with 1387 participants. The average age was 69 years and all trials included men and women. Participants were followed for up to two years. There was an improvement in primary duplex patency at six and 12 months in participants treated with PTA plus stent over lesions treated with PTA alone (six months: odds ratio (OR) 2.90, 95% confidence interval (CI) 1.17 to 7.18, P = 0.02, six studies, 578 participants; 12 months: OR 1.78, 95% CI 1.02 to 3.10, P = 0.04, nine studies, 858 participants). This was lost by 24 months (P = 0.06). There was a significant angiographic patency benefit at six months (OR 2.49, 95% CI 1.49 to 4.17, P = 0.0005, four studies, 329 participants) which was lost by 12 months (OR 1.30, 95% CI 0.84 to 2.00, P = 0.24, five studies, 384 participants). Ankle brachial index (ABI) and treadmill walking distance showed no improvement at 12 months (P = 0.49 and P = 0.57 respectively) between participants treated with PTA alone or PTA with stent insertion. Three trials (660 participants) reported quality of life, which showed no significant difference between participants treated with PTA alone or PTA with stent insertion at any time interval. Antiplatelet therapy protocols and inclusion criteria regarding affected arteries between trials showed marked heterogeneity. AUTHORS' CONCLUSIONS: Although there was a short-term gain in primary patency there was no sustained benefit from primary stenting of lesions of the superficial femoral artery in addition to angioplasty. Future trials should focus on quality of life for claudication and limb salvage for critical ischaemia.


Subject(s)
Angioplasty, Balloon/methods , Femoral Artery , Peripheral Vascular Diseases/therapy , Stents , Aged , Anticoagulants/therapeutic use , Combined Modality Therapy/methods , Female , Humans , Intermittent Claudication/therapy , Male , Quality of Life , Randomized Controlled Trials as Topic , Vascular Patency
6.
Cochrane Database Syst Rev ; (5): CD001487, 2010 May 12.
Article in English | MEDLINE | ID: mdl-20464717

ABSTRACT

BACKGROUND: Femoro-popliteal bypass is implemented to save limbs that might otherwise require amputation, in patients with ischaemic rest pain or tissue loss; and to improve walking distance in patients with severe life-limiting claudication. Contemporary practice involves using autologous vein, polyterafluoroethylene (PTFE) or Dacron as a bypass conduit.This is an update of a Cochrane review first published in 1999 and previously updated in 2002. OBJECTIVES: The objective of this review was to determine the most effective type of graft for femoro-popliteal bypass surgery. SEARCH STRATEGY: The Cochrane Peripheral Vascular Diseases Group searched their Specialised Register (last searched January 2010) and the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2010, Issue 1 for last search). The authors searched reference lists of relevant articles, and handsearched conference proceedings from the British and European Vascular Surgical Societies. SELECTION CRITERIA: Randomised trials comparing femoro-popliteal grafts. DATA COLLECTION AND ANALYSIS: Two authors (CT and ADM) screened studies, extracted data and assessed trials. MAIN RESULTS: Thirteen randomised control trials were included with a total of 2313 patients (1955 above knee, 358 below knee bypass surgery). Seven graft types were compared (reversed and in situ autologous vein, PTFE with and without vein cuff, human umbilical vein (HUV), Dacron and heparin bonded Dacron (HBD).Above the knee, there was a benefit in primary patency for autologous vein over PTFE (P = 0.0001) and HUV (P = 0.0003) by 60 months. Dacron showed primary patency benefit over PTFE by 24 months (P = 0.02), continuing to 60 months (P = 0.02). HUV also showed benefit over PTFE by 24 months (P = 0.0003) in one trial. Below the knee, in the one trial there was a significant benefit in primary patency for PTFE with a vein cuff when compared to PTFE alone at all time intervals to 24 months (P = 0.03).Limited data were available for limb survival. Antiplatelet and anticoagulant protocols varied extensively between trials, and in some cases within trials. AUTHORS' CONCLUSIONS: There was a clear primary patency benefit for autologous vein when compared to synthetic materials for above knee bypasses. In the long term (five years) Dacron confers a small primary patency benefit over PTFE for above knee bypass. PTFE with a vein cuff improved primary patency when compared to PTFE alone for below knee bypasses. Further randomised data is needed to ascertain whether this information translates into improvement in limb survival.


Subject(s)
Arterial Occlusive Diseases/surgery , Femoral Artery/surgery , Leg/blood supply , Popliteal Artery/surgery , Saphenous Vein/transplantation , Umbilical Veins/transplantation , Blood Vessel Prosthesis Implantation , Humans , Intermittent Claudication/surgery , Polyethylene Terephthalates , Polytetrafluoroethylene , Randomized Controlled Trials as Topic , Transplantation, Autologous , Vascular Surgical Procedures
7.
Cochrane Database Syst Rev ; (2): CD006767, 2009 Apr 15.
Article in English | MEDLINE | ID: mdl-19370653

ABSTRACT

BACKGROUND: Lower limb peripheral arterial disease (PAD) is a common, important manifestation of systemic atherosclerosis. Stenoses or occlusions in the superficial femoral artery may result in intermittent claudication as an early consequence, which may be treated by balloon angioplasty with or without stenting. OBJECTIVES: The objective was to determine the effect of percutaneous transluminal angioplasty (PTA) when compared with PTA with stenting for lesions of the superficial femoral artery, for people with intermittent claudication or critical limb ischaemia. SEARCH STRATEGY: The Cochrane Peripheral Vascular Diseases (PVD) Group searched their trials register (last searched February 2009) and the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library (2009, Issue 1) for publications describing randomised controlled trials (RCTs) of percutaneous angioplasty with or without stenting. SELECTION CRITERIA: Randomised trials of angioplasty alone versus angioplasty with stenting for the treatment of superficial femoral artery stenoses. DATA COLLECTION AND ANALYSIS: Two authors (CT, JC) independently selected suitable trials,assessed trial quality and extracted data. A third author (AS) ranked the concealment of allocation and checked the final manuscript. The fourth author (DM) cross checked all stages of the review process. MAIN RESULTS: Eight trials with 968 participants were included. The average age was 67 and all trials included men and women. Participants were followed for up to two years.There was a small but statistically significant improvement in primary angiographic and duplex patency at six months in patients treated with PTA plus stent over lesions treated with PTA alone (three trials and four trials, respectively). However, primary angiographic patency was non-significant 12 months (five trials, P = 0.23) and 24 months (two trials, P = 0.45). A similar but lesser effect was seen for ankle brachial pressure index (ABPI), while a more pronounced improvement in treadmill walking distance in patients with PTA plus stent insertion was observed at six and 12 (P < 0.0001), but not 24 months (P = 0.81). Only one trial reported quality of life, which showed no significant difference between patients treated with PTA alone or PTA with stent insertion at any time interval. Antiplatelet therapy protocols and inclusion criteria between trials showed marked heterogenicity. AUTHORS' CONCLUSIONS: There is limited benefit to stenting lesions of the superficial femoral artery in addition to angioplasty, however this cannot be recommended routinely based on the results of this analysis.


Subject(s)
Angioplasty, Balloon/methods , Femoral Artery , Peripheral Vascular Diseases/therapy , Stents , Aged , Anticoagulants/therapeutic use , Combined Modality Therapy/methods , Female , Humans , Intermittent Claudication/therapy , Male , Randomized Controlled Trials as Topic
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