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This report details a prospectively randomized clinical trial comparing mechanical clamp compression to hand applied pressure for attaining vascular hemostasis after coronary intervention. Effectiveness was determined by comparing the incidence of femoral vascular complications resulting from each of the 2 techniques. Eligible participants included 778 consecutive patients scheduled for percutaneous coronary intervention over an 8-month period. An unselected cohort of the eligible patients (n = 592), determined by the availability of cross-trained clinicians, underwent follow-up serial physical examinations by blinded observers for the duration of their hospital stay. A second, similarly determined cohort (n = 390), underwent color-duplex ultrasonography within 24 hours of sheath removal. Baseline demographic and clinical characteristics, sheath removal parameters, and subsequent outcomes were collected prospectively. The primary end point was a composite of ultrasound-defined femoral vascular complications: femoral artery thrombosis, echogenic hematoma, pseudoaneurysm, or arteriovenous fistulae formation. Complications diagnosed by physical examination constituted the second fundamental end point and included: persistent oozing, ecchymosis, hematoma, bruit, and pulsatile mass. Compared to manual compression, mechanical clamp hemostasis reduced the primary adverse end point by 63% (p = 0.041). Physical examination detected ecchymosis, oozing, and hematomas at equally high frequencies in the two cohorts. Although 65% of the patients in both treatment groups encountered at least one of these cosmetic complications, the diagnoses made by physical examination did not correlate with ultrasound-defined pathology. Multivariable stepwise logistic regression analysis identified a relationship of advanced age and lower body weight to vascular complications. Utilization of a mechanical clamp rather than conventional hand pressure to attain vascular hemostasis significantly reduces ultrasound-defined femoral vascular pathology. Discrepancies between physical examination and ultrasound diagnoses challenge the utility of clinical assessment alone and establish ultrasound as the diagnostic modality of choice. [ABSTRACT FROM AUTHOR]

Background Context: Spinal fusion surgeries are one of the most common types of operations performed during inpatient stays in the United States. Successful wound closure, including watertight closure at the skin layer, plays in important role in patient outcomes.Purpose: To compare the economic and clinical outcomes of spinal fusion surgeries using one of two sutureless skin closure techniques: skin staples plus waterproof wound dressings (SSWWD) or 2-octyl cyanoacrylate plus polymer mesh tape (2OPMT).Study Design/setting: Retrospective study using a multi-hospital database.Patient Sample: Patients undergoing inpatient spinal fusion surgery for a spine disorder between October 1, 2015 and March 31, 2019.Outcome Measures: Total costs from the hospital perspective, operating room time (ORT), hospital length of stay (LOS), non-home discharge, infection/wound complications during the 90-day global period (index surgery through 90 days post-discharge), and 30/60/90-day all-cause readmissions.Methods: Outcomes were compared between study groups using nearest neighbor propensity score matching with exact matching on 45 primary procedure/diagnosis code groupings and generalized estimating equations to account for hospital-level clustering. This study was sponsored by Ethicon, Inc., a Johnson & Johnson company; the authors are employees or consultants of Johnson & Johnson.Results: A total of 11,991 patients met the study criteria (2OPMT=5,961; SSWWD=6,030), of which 3,602 were included in each post-match study comparison group (total=7,204). As compared with the SSWWD group, the 2OPMT group had statistically significant lower median ORT (240 vs. 270 minutes; p=0.002), mean LOS (3.35 [SD=2.6] vs. 3.86 [SD=2.8] days, p=0.031), risks of non-home discharge status (17.63% vs. 23.10%, p=0.035), overall infections/wound complications (1.37% vs. 2.48%, p=0.015), and surgical site infection (1.11% vs. 2.07%, p=0.023). Differences between the study groups in total hospital costs, all-cause readmissions, and other sub-components of the infection/wound complication composite outcome were statistically insignificant (p>0.05).Conclusions: In this retrospective observational study of patients undergoing elective inpatient spinal fusion surgery, the use of 2OPMT for skin closure was associated with significantly lower ORT, LOS, non-home discharge, and 90-day rates of infections/wound complications as compared with SSWWD. [ABSTRACT FROM AUTHOR]

We compared the safety and effectiveness of minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) to open TLIF (O-TLIF) for lumbar degenerative disease. We systematically searched Medline, Embase, and the Cochrane Central Register of Controlled Trials for randomized trials of MI-TLIF versus O-TLIF. The perioperative outcomes included the procedure time, fluoroscopy time, blood loss, complications, and hospital stay. The midterm outcomes included pseudarthrosis, the Oswestry Disability Index, and pain severity—all reported at 1-year minimum follow-up. A total of 7 randomized trials including 496 patients (246 MI-TLIF; 250 O-TLIF) were included in our review. No statistically significant group differences in procedure time (mean difference [MD], −4 minutes; P = 0.70) were found. However, the fluoroscopy time was significantly longer with MI-TLIF (MD, 48 seconds; P < 0.001). MI-TLIF resulted in less perioperative blood loss (MD, −200 mL; P < 0.001) and shorter hospitalization (MD, −2.2 days; P < 0.001) compared with O-TLIF. The risk of perioperative complications was comparable between the 2 groups (risk ratio, 1.03; P = 0.94). No group differences were found in the incidence of pseudarthrosis at the 1-year minimum follow-up (risk ratio, 0.84; P = 0.67). Pain severity at midterm follow-up was comparable between the 2 groups (MD, −1; P = 0.59), and the ODI was slightly lower in the MI-TLIF group (MD, −3; P = 0.01). Relative to O-TLIF, MI-TLIF was associated with less blood loss, a shorter hospital stay, and slightly less disability, at the expense of longer fluoroscopy times. [ABSTRACT FROM AUTHOR]