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Initiation of SGLT2 Inhibitors and the Risk of Lower Extremity Minor and Major Amputation in Patients with Type 2 Diabetes and Peripheral Arterial Disease: A Health Claims Data Analysis.
Rodionov, RN, Peters, F, Marschall, U, L'Hoest, H, Jarzebska, N, Behrendt, CA
European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery. 2021;(6):981-990
Abstract
OBJECTIVE To assess the association between long term risk of hospitalisation for heart failure (HHF) and lower extremity minor and major amputation (LEA) in patients initiating sodium glucose cotransporter 2 inhibitors (SGLT2i) suffering from type 2 diabetes and peripheral arterial disease (PAD). Outcomes were compared with patients without PAD and evaluated separately for the time periods before and after the official warning of the European Medicines Agency (EMA) in early 2017. METHODS This study used BARMER German health claims data including all patients suffering from type 2 diabetes initiating SGLT2i therapy between 1 January 2013 and 31 December 2019 with follow up until the end of 2020. New users of glucagon like peptide 1 receptor agonists (GLP1-RAs) were used as active comparators. Inverse probability weighting with truncated stabilised weights was used to adjust for confounding, and five year risks of HHF and LEA were estimated using Cox regression. Periods before and after the EMA warning were analysed separately and stratified by presence of concomitant PAD. RESULTS In total, 44 284 (13.6% PAD) and 56 878 (16.3% PAD) patients initiated SGLT2i or GLP1-RA, respectively. Before the EMA warning, initiation of SGLT2i was associated with a lower risk of HHF in patients with PAD (hazard ratio, HR, 0.85, 95% confidence interval, CI, 0.73 - 0.99) and a higher risk of LEA in patients without PAD (HR 1.79, 95% CI 1.04 - 2.92). After the EMA warning, the efficacy and safety endpoints were no longer statistically different between groups. CONCLUSION The results from this large nationwide real world study highlight that PAD patients exhibit generally high amputation risks. This study refutes the idea that the presence of PAD explains the excess LEA risk associated with initiation of SGLT2i. The fact that differentials among study groups diminished after the EMA warning in early 2017 emphasises that regulatory surveillance measures worked in everyday clinical practice.
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Analgesics Administered for Pain During Hospitalization Following Lower Extremity Fracture: A Review of the Literature.
Griffioen, MA, OʼBrien, G
Journal of trauma nursing : the official journal of the Society of Trauma Nurses. 2018;(6):360-365
Abstract
Effective treatment of acute pain during hospitalization following lower extremity fracture is critical to improve short-term patient outcomes including wound healing, stress response, hospital length of stay, and cost as well as minimizing long-term negative patient outcomes such as delayed return to work, disability, and chronic pain. As many patients report moderate to severe pain during hospitalization, identifying the analgesics that most effectively reduces pain is a priority to improve patient outcomes. The purpose of this review was to examine published studies describing patient response to analgesics administered orally (PO) or intravenously (IV) in the immediate hospitalization following lower extremity fracture. PubMed was queried for articles published through May 2017 that included information on type of study, population, fracture site, pain measurement tool, analgesic, and result. Of 514 articles found, eight met the inclusion criteria. Analgesics administered PO or IV were fentanyl, hydromorphone, morphine, remifentanil, diclofenac, ibuprofen, ketorolac, and etoricoxib. Five of the studies focused on comparisons between one or more analgesics and three studies compared an IV analgesic to a regional anesthetic agent. Two studies compared different nonsteroidal anti-inflammatory drugs (NSAIDs). Bupivacaine, lignocaine, and levobupivacaine administered as regional nerve blocks were superior to controlling pain compared with IV fentanyl and IV hydromorphone. IV morphine provided faster and better pain relief compared with IV ibuprofen. Based on the limited data available, regional nerve blocks provided superior pain relief compared with opioids, and opioids provided superior pain relief compared with NSAIDs. Different NSAIDs provided similar pain relief.
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Treatment protocol on stasis edema in poorly mobile nursing home patients.
Benigni, JP, Uhl, JF, Balet, F, Chahim, M
International angiology : a journal of the International Union of Angiology. 2018;(5):396-399
Abstract
BACKGROUND Prolonged immobility in the sitting position in the elderly is known to produce venous stasis with leg edema and possible skin changes. METHODS The authors have tested a treatment protocol in 30 patients to quantify the reduction of volume caused by an adjustable compression Velcro® wrap (Circaid Juxtalite®, medi GmbH, Bayreuth, Germany) after 15 days and to compare its effect on the leg volume for the next 15 days with 15- to 20-mmHg compression stockings (CS). RESULTS The authors noted a volume decrease between T0 and T15 by 10.8% (52 legs) under Circaid Juxtalite®. At T30, they observed a non-significant difference between Circaid Juxtalite® (-1%) and the CS (1.3%). CONCLUSIONS A Velcro® adjustable compression wrap (Circaid Juxtalite®) is efficient in reducing stasis edema in the elderly. Stabilization of the leg volume with the use of 15-20 mmHg CS suggests that a high pressure to maintain results is not required to maintain results.
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Differences in lumbar spine and lower extremity kinematics in people with and without low back pain during a step-up task: a cross-sectional study.
Mitchell, K, Porter, M, Anderson, L, Phillips, C, Arceo, G, Montz, B, Levy, S, Gombatto, SP
BMC musculoskeletal disorders. 2017;(1):369
Abstract
BACKGROUND Low back pain (LBP) affects more than one third of the population at any given time, and chronic LBP is responsible for increased medical costs, functional limitations and decreased quality of life. A clear etiology is often difficult to identify, but aberrant posture and movement are considered contributing factors to chronic LBP that are addressed during physiotherapy intervention. Information about aberrant movement during functional activities in people with LBP can help inform more effective interventions. The purpose of this study was to determine if there are differences in lumbar spine and lower extremity kinematics in people with and without LBP during a step-up task. METHODS A convenience sample of 37 participants included 19 with LBP and 18 without a history of LBP. All participants were between the ages of 18 and 65, and controls were matched to participants with LBP based on age, gender and BMI. A motion capture system was used to record spine and lower extremity kinematics during the step-up task. ANOVA tests were used to determine differences in three-dimensional kinematics between groups. RESULTS Participants with LBP displayed less lower lumbar motion in the sagittal plane (P = 0.001), more knee motion in the coronal plane (P = 0.001), and more lower extremity motion in the axial plane (P = 0.002) than controls. CONCLUSIONS People with LBP display less lower lumbar spine motion in the sagittal plane and more out-of-plane lower extremity motion. Clinically, the step-up task can be used to identify these aberrant movements to develop more focused functional interventions for patients with LBP. TRIAL REGISTRATION Not applicable.
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Effect of dietary restriction and exercise on lower extremity tissue compartments in obese, older women: a pilot study.
Manini, TM, Buford, TW, Lott, DJ, Vandenborne, K, Daniels, MJ, Knaggs, JD, Patel, H, Pahor, M, Perri, MG, Anton, SD
The journals of gerontology. Series A, Biological sciences and medical sciences. 2014;(1):101-8
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BACKGROUND Accumulating evidence suggests that both dietary restriction and exercise (DR + E) should be incorporated in weight loss interventions to treat obese, older adults. However, more information is needed on the effects to lower extremity tissue composition-an important consideration for preserving mobility in older adults. METHODS Twenty-seven sedentary women (body mass index: 36.3±5.4kg/m(2); age: 63.6±5.6 yrs) were randomly assigned to 6 months of DR + E or a health education control group. Thigh and calf muscle, subcutaneous adipose tissue (SAT), and intermuscular adipose tissue (IMAT) size were determined using magnetic resonance imaging. Physical function was measured using a long-distance corridor walk and knee extension strength. RESULTS Compared with control, DR + E significantly reduced body mass (-6.6±3.7kg vs control: -0.05±3.5kg; p < .01). Thigh and calf muscle volumes responded similarly between groups. Within the DR + E group, adipose tissue was reduced more in the thigh than in the calf (p < .04). Knee extension strength was unaltered by DR + E, but a trend toward increased walking speed was observed in the DR + E group (p = .09). Post hoc analyses showed that reductions in SAT and IMAT within the calf, but not the thigh, were associated with faster walking speed achieved with DR + E (SAT: r = -0.62; p = .01; IMAT r = -0.62; p = .01). CONCLUSIONS DR + E preserved lower extremity muscle size and function and reduced regional lower extremity adipose tissue. Although the magnitude of reduction in adipose tissue was greater in the thigh than the calf region, post hoc analyses demonstrated that reductions in calf SAT and IMAT were associated with positive adaptations in physical function.
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Discomfort assessment in peripheral angiography: randomized clinical trial of Iodixanol 270 versus Ioversol 320 in diabetics with critical limb ischemia.
Palena, LM, Sacco, ZD, Brigato, C, Sultato, E, Barra, D, Candeo, A, Manzi, M
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions. 2014;(6):1019-25
Abstract
OBJECTIVES To assess and compare the intra-arterial injection-associated discomfort of iodinated contrast media (CM) and the impact on diagnostic efficacy in diabetics with critical limb ischemia (CLI). BACKGROUND Arterial revascularization is a mainstay in patients with CLI. Previous diagnostic angiography is a crucial step that can be affected by CM injection discomfort compromising the revascularization results, and it could vary related to the CM agents. METHODS One hundred forty-eight patients received Iodixanol 270 mg iodine pro ml or Ioversol 320 mg iodine pro ml in a prospective, double-blind, randomized, parallel-group clinical trial. Injection-associated discomfort was assessed by Visual Analogic Scale (VAS). Diagnostic efficacy and safety up to 1 week were evaluated. RESULTS The incidence of pain has been around 50% of the all population in study, with lesser incidence of pain (25.7% vs 74.3%; P < 0.0001) and of heat sensation (55.4% vs 85.1%; P < 0.0001), after Iodixanol than after Ioversol injection. Discomfort mean score, according to VAS assessment, was less in the Iodixanol group (8.1 ± 15.3) than in the Ioversol group (36.0 ± 29.7), after first injection (P < 0.001) and for all injections (P < 0.001). A significant difference was also observed in favor of Iodixanol (P < 0.001), respect to mean score of discomfort and heat sensation, assessed by the operators after all the CM injections. CONCLUSIONS Iodixanol caused less frequent and severe discomfort, characterized as pain and heat during intra-arterial administration compared with Ioversol. The pain severity is tightly related to image and diagnosis quality with an impact on the patients for additional injections and larger CM volumes.
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Oral supplementation with 25(OH)D3 versus vitamin D3: effects on 25(OH)D levels, lower extremity function, blood pressure, and markers of innate immunity.
Bischoff-Ferrari, HA, Dawson-Hughes, B, Stöcklin, E, Sidelnikov, E, Willett, WC, Edel, JO, Stähelin, HB, Wolfram, S, Jetter, A, Schwager, J, et al
Journal of bone and mineral research : the official journal of the American Society for Bone and Mineral Research. 2012;(1):160-9
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To test the effect of 25(OH)D(3) (HyD) compared to vitamin D(3) on serum 25-hydroxyvitamin D levels (25(OH)D), lower extremity function, blood pressure, and markers of innate immunity. Twenty healthy postmenopausal women with an average 25(OH)D level of 13.2 ± 3.9 ng/mL (mean ± SD) and a mean age of 61.5 ± 7.2 years were randomized to either 20 µg of HyD or 20 µg (800 IU) of vitamin D(3) per day in a double-blind manner. We measured on 14 visits over 4 months, 25(OH)D serum levels, blood pressure, and seven markers of innate immunity (eotaxin, interleukin [IL]-8, IL-12, interferon gamma-induced protein 10 kDa [IP-10], monocyte chemotactic protein-1 [MCP-1], macrophage inflammatory protein beta [MIP-1β], and "Regulated upon Activation, Normal T-cell Expressed, and Secreted" [RANTES]). At baseline and at 4 months, a test battery for lower extremity function (knee extensor and flexor strength, timed up and go, repeated sit-to-stand) was assessed. All analyses were adjusted for baseline measurement, age, and body mass index. Mean 25(OH)D levels increased to 69.5 ng/mL in the HyD group. This rise was immediate and sustained. Mean 25(OH)D levels increased to 31.0 ng/mL with a slow increase in the vitamin D(3) group. Women on HyD compared with vitamin D(3) had a 2.8-fold increased odds of maintained or improved lower extremity function (odds ratio [OR] = 2.79; 95% confidence interval [CI], 1.18-6.58), and a 5.7-mmHg decrease in systolic blood pressure (p = 0.0002). Both types of vitamin D contributed to a decrease in five out of seven markers of innate immunity, significantly more pronounced with HyD for eotaxin, IL-12, MCP-1, and MIP-1 β. There were no cases of hypercalcemia at any time point. Twenty micrograms (20 µg) of HyD per day resulted in a safe, immediate, and sustained increase in 25(OH)D serum levels in all participants, which may explain its significant benefit on lower extremity function, systolic blood pressure, and innate immune response compared with vitamin D(3).
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Comparison of orbital atherectomy plus balloon angioplasty vs. balloon angioplasty alone in patients with critical limb ischemia: results of the CALCIUM 360 randomized pilot trial.
Shammas, NW, Lam, R, Mustapha, J, Ellichman, J, Aggarwala, G, Rivera, E, Niazi, K, Balar, N
Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists. 2012;(4):480-8
Abstract
PURPOSE To evaluate the role of orbital atherectomy in calcified infrapopliteal arteries in patients with critical limb ischemia compared to balloon angioplasty (BA) alone. METHODS A randomized multicenter study was undertaken to evaluate short and 1-year outcomes in 50 patients (32 men; mean age 71 years, range 40-90) with confirmed calcified lesions using 1∶1 randomization to the Diamondback 360° Orbital Atherectomy System followed by BA vs. BA alone. All patients had severe (≥50% stenosis) peripheral artery disease (Rutherford classification 4-6) in the popliteal, tibial, and/or peroneal arteries. The primary endpoint was defined as restoration of a normal lumen (residual stenosis ≤30%) with no bailout stenting or dissection types C through F. Scheduled follow-up visits were conducted according to a common protocol at 1, 6, and 12 months. RESULTS Procedural success was 93.1% (27/29 lesions) for atherectomy + BA patients and 82.4% (28/34 lesions) for BA alone (p = 0.27). Bailout stenting was needed in 2 (6.9%) of the 29 atherectomy + BA lesions and in 5 (14.3%) of the 35 BA-treated lesions (p = 0.44). At 1 year, there were no amputations in either group related to the index procedure. Estimates for freedom from target vessel revascularization and all-cause mortality were 93.3% and 100% in the atherectomy + BA group vs. 80.0% (p = 0.14) and 68.4% (p = 0.01) in the BA group, respectively. Proportional hazard models evaluating survival time vs. status of residual stenosis determined a hazard ratio for major adverse events of 5.6 for patients with an acute post-procedure residual stenosis >30% (p = 0.01). CONCLUSION Debulking with orbital atherectomy appeared to increase the chance of reaching a desirable angioplasty result, with less acute need for bailout stenting and a higher procedure success. A negative association between procedure success and risk of serious adverse outcomes should encourage larger confirmatory studies.
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Variability and persistence of aspirin response in lower extremity peripheral arterial disease patients.
Saunders, J, Nambi, V, Kimball, KT, Virani, SS, Morrisett, JD, Lumsden, AB, Ballantyne, CM, Dong, JF, ,
Journal of vascular surgery. 2011;(3):668-75
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OBJECTIVE To determine the prevalence of poor response to aspirin (ASA) therapy over 12-month follow-up in patients with lower extremity peripheral arterial disease (PAD), and to compare the classification agreement among different ASA response assays. METHODS Patients with PAD on ASA therapy at baseline were included from the ongoing Effect of Lipid Modification on Peripheral Arterial Disease after Endovascular Intervention Trial (ELIMIT), which is a randomized trial testing whether combination treatment with ezetimibe, niacin, and a statin will halt/regress atherosclerosis compared with statin monotherapy. Patients who had baseline platelet testing and repeat testing at 6-month or 12-month follow-up were included. ASA responsiveness was tested using three different assays: Optical aggregation with 0.5 mg/mL of arachidonic acid (AA), optical aggregation with 10 μM of adenosine diphosphate (ADP), and platelet function analyzer-100 (PFA-100) testing with collagen/epinephrine (Epi) loaded cartridges. ASA response was defined as AA aggregation <30%, ADP aggregation <70%, or PFA-100 Epi >164 seconds. Patients who showed response to ASA at baseline were classified as Responders. Poor response to ASA was defined as AA aggregation ≥ 30%, ADP aggregation ≥ 70%, or PFA-100 Epi ≤ 164 seconds. Patients who showed poor response (PR) to an assay at baseline, but then were responsive at follow-up visits were classified as Initial PRs. Patients who showed poor response at baseline and all follow-up visits were classified as Persistent PRs. The classification agreement between assays was tested using the kappa statistic. RESULTS Of 102 patients randomized in ELIMIT, 80 patients satisfied inclusion criteria. There were no significant baseline demographic differences between Responders, Initial PRs, and Persistent PRs. The prevalence of persistent poor response varied by the assay used; 5% of subjects (4/80) were Persistent PRs by AA aggregation, compared with 27.5% (22/80) of subjects by ADP aggregation and 9.9% (7/71) of patients by PFA-100 Epi. Regarding the agreement of the assays, only AA aggregation and PFA-100 Epi agreed significantly (K = 0.3223; 95% confidence interval [CI] 0.15-0.493; P = .0001), and though statistically significant, the magnitude of this agreement is small. AA aggregation and ADP aggregation did not agree (K = 0.1161; 95% CI -0.004-0.236; P = .029), nor did ADP aggregation and PFA-100 Epi (K = 0.0044; 95% CI -0.151-0.160; P = .48). CONCLUSIONS Between 5% and 27.5% of PAD patients were Persistent PRs to ASA over 6- to 12-month follow-up using different platelet assays. Further, these commonly used platelet assays show weak agreement in determining poor response to aspirin.
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One-year outcome of percutaneous rotational atherectomy with aspiration in infrainguinal peripheral arterial occlusive disease: the multicenter pathway PVD trial.
Zeller, T, Krankenberg, H, Steinkamp, H, Rastan, A, Sixt, S, Schmidt, A, Sievert, H, Minar, E, Bosiers, M, Peeters, P, et al
Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists. 2009;(6):653-62
Abstract
PURPOSE To report a safety and efficacy study of a novel rotational atherectomy system with aspiration capabilities for the treatment of infrainguinal arterial lesions. METHODS From February 2006 to January 2007, 172 patients (88 women; mean age 72 years, range 51-93; 47% diabetics) with Rutherford class 1-5 lower limb ischemia were enrolled at 9 study sites. Inclusion criteria were atherosclerotic stenoses >70% and up to 10 cm long in the femoropopliteal segment or up to 3 cm long in the infrapopliteal vessels (reference vessel diameter 3.0-5.0 mm). In the study, 210 lesions (mean length 2.7 cm) were treated with the Pathway PV System, including total occlusions (31%), lesions with a moderate to high calcium score (51%), and post-angioplasty (non-stent) restenotic lesions (15%). The primary study endpoint was the 30-day major adverse event (MAE) rate. RESULTS Device success was 99% (208/210 lesions). MAE at 30 days was 1% (2 preplanned amputations). Clinically driven target lesion revascularization rates at 6 and 12 months were 15% (25/172) and 26% (42/162), respectively. The 1-year restenosis rate was 38.2% based on duplex imaging. The ankle-brachial index increased significantly from 0.59+/-0.21 at baseline to 0.82+/-0.27 (p<0.05) at 12 months. Mean Rutherford class improved from 3.0+/-0.9 at baseline to 1.5+/-1.3 at 1 year (p<0.05). CONCLUSION The use of the Pathway PV System in atherosclerotic lesions appears to be safe and effective in improving stenosis severity, even in the presence of challenging lesion conditions. Vessel patency following intervention appears to be good up to 12 months, and these results translate into clinical benefit.