Browsing by Subject "lower extremity"

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    Impact of Procedural Bleeding in Peripheral Artery Disease: An Analysis From EUCLID Trial.
    (Circulation. Cardiovascular interventions, 2019-10-04) Kansal, Aman; Huang, Zhen; Rockhold, Frank W; Baumgartner, Iris; Berger, Jeffrey S; Blomster, Juuso I; Fowkes, F Gerry; Katona, Brian; Mahaffey, Kenneth W; Norgren, Lars; Hiatt, William R; Patel, Manesh R; Jones, W Schuyler
    BACKGROUND:The relationship between invasive vascular procedures and bleeding in patients with peripheral artery disease has not been well described in the literature. This post hoc analysis from the EUCLID trial (Examining Use of Ticagrelor in Peripheral Artery Disease) aimed to describe the incidence of major and minor postprocedural bleeding and characterize the timing and severity of bleeding events relative to the procedure. METHODS:EUCLID was a multicenter, randomized controlled trial of 13 885 patients with symptomatic peripheral artery disease that tested the efficacy and safety of ticagrelor compared with clopidogrel for the prevention of major adverse cardiovascular events. A total of 2661 patients underwent 3062 coronary revascularization, peripheral revascularization, and amputation during the study. The primary safety end point was Thrombolysis in Myocardial Infarction major or minor bleeding. All bleeding events were formally adjudicated by a clinical end point classification group. RESULTS:Major bleeding events most often occurred ≤7 days following the procedure. The incidence of Thrombolysis in Myocardial Infarction major or minor bleeding ≤7 days following peripheral revascularization (3.3%; 95% CI, 2.5%-4.1%) was similar to rates after coronary revascularization (4.0%; 95% CI, 2.6%-5.4%) and lower extremity amputation (2.3%; 95% CI, 0.8%-3.8%). The severity of bleeding events (as graded by drop in hemoglobin, need for transfusion, bleeding in a critical location, and fatal bleeding) was also similar following peripheral, coronary revascularization, and lower extremity amputation. CONCLUSIONS:The incidence of Thrombolysis in Myocardial Infarction major/minor bleeding following peripheral revascularization is comparable to rates after coronary revascularization and lower extremity amputation, and the majority of bleeding events occur within 7 days following the procedure. The severity of periprocedural bleeding is also similar after procedures, with the most frequently adjudicated reason being a drop in hemoglobin ≥2 g/dL. Future studies should be performed to enhance our understanding of bleeding risk related to revascularization and amputation procedures in peripheral artery disease patients.
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    Patient and procedural risk factors for decline in lower-extremity motor scores following adult spinal deformity surgery.
    (Journal of neurosurgery. Spine, 2023-04) Mohanty, Sarthak; Hassan, Fthimnir M; Lenke, Lawrence G; Burton, Douglas; Daniels, Alan H; Gupta, Munish C; Kebaish, Khaled M; Kelly, Michael; Kim, Han Jo; Klineberg, Eric O; Passias, Peter G; Protopsaltis, Themistocles; Schwab, Frank; Shaffrey, Christopher I; Smith, Justin S; Line, Breton G; Lafage, Renaud; Lafage, Virginie; Bess, Shay

    Objective

    The purpose of this study was to discern factors that differentiate patients who experience postoperative lower-extremity motor function decline in the early postoperative period.

    Methods

    Adult spinal deformity (ASD) patients who were enrolled in a multicenter, observational, and prospectively collected study from 2018 to 2021 at 18 spinal deformity centers in North America were queried. Eligible participants met at least one of the following radiographic and/or procedural inclusion criteria: pelvic incidence minus lumbar lordosis (PI-LL) ≥ 25°, T1 pelvic angle (T1PA) ≥ 30°, sagittal vertical axis (SVA) ≥ 15 cm, thoracic scoliosis ≥ 70°, thoracolumbar scoliosis ≥ 50°, global coronal malalignment ≥ 7 cm, 3-column osteotomy, spinal fusion ≥ 12 levels, and/or age ≥ 65 years with ≥ 7 levels of instrumentation. Patients with an inflammatory or autoimmune disease and those who were incarcerated or pregnant were excluded, as were non-English speakers. Only patients with baseline and 6-week postoperative lower-extremity motor score (LEMS) were analyzed. Patient information, including demographic data, operative data, patient-reported outcomes, and radiographic parameters, were collected. Univariate and multivariable logistic regression models were built to quantify the degree to which a patient's postoperative LEMS decline was related to demographic and clinical characteristics.

    Results

    In total, 205 patients (mean age 61.5 years, mean total instrumented levels 12.6, 67.3% female, 54.2% primary cases, 79.5% with pelvic fixation) were evaluated. Of these 205 patients, 32 (15.5%) experienced LEMS decline in the perioperative period. These patients were older (p = 0.0014) and had greater BMI (p = 0.0176), higher frailty scores (p = 0.047), longer operating room times (p = 0.033), and greater estimated blood loss (p < 0.0001), and they were more frequently observed to have intraoperative neurophysiological monitoring (IONM) changes (p = 0.018). The deteriorated cohort had greater C7SVA at baseline (p = 0.0028) but were comparable in terms of all other radiographic parameters. No radiographic differences were seen between the groups at the 6-week visit; however, the deteriorated cohort experienced greater change in PI-LL (p < 0.0001), lumbar lordosis (p = 0.0461), C7SVA (p = 0.0004), and T1PA (p < 0.0001). Multivariate logistic regression demonstrated that the presence of IONM changes and each degree of negative change in T1PA conferred 3.71 (95% CI 1.01-13.42) and 1.09 (1.01-1.19) greater odds of postoperative LEMS deterioration, respectively.

    Conclusions

    In this study, 15.6% of ASD patients incurred LEMS decline in the perioperative period. The magnitude of change in global sagittal alignment, specifically T1PA, was the strongest independent predictor of LEMS decline, which has implications for surgical planning, patient counseling, and clinical research.