Abstract

Background The effectiveness of vascular closure devices (VCDs) to reduce bleeding after transfemoral percutaneous coronary intervention remains unsettled. Methods and Results Participants in the REGULATE-PCI (Effect of the REG1 anticoagulation system versus bivalirudin on outcomes after percutaneous coronary intervention) trial who underwent transfemoral percutaneous coronary intervention with VCD implantation were compared with those who underwent manual compression. The primary effectiveness end point was type 2, 3, or 5 Bleeding Academic Research Consortium access site bleeding at day 3. Univariate and multivariate analyses were adjusted by the inverse probability weighting method using propensity score. Time to hemostasis and time to ambulation were compared between groups. Of the 1580 patients who underwent transfemoral percutaneous coronary intervention, 1004 (63.5%) underwent VCD implantation and 576 (36.5%) had manual compression. The primary effectiveness end point occurred in 64 (6.4%) participants in the VCD group and in 38 (6.6%) participants in the manual compression group (inverse probability weighting-adjusted odds ratio, 1.02 [95% CI, 0.77-1.36]; P=0.89). There were statistically significant 2-way interactions between VCD use and female sex, chronic kidney disease, and use of high-potency P2Y12 inhibition (ticagrelor or prasugrel) (P<0.05 for all) with less bleeding with VCD use in these high-risk subgroups. Median time to hemostasis and time to ambulation were shorter in the VCD versus the manual compression group (P<0.01 for both). Conclusions Following transfemoral percutaneous coronary intervention, VCD use is associated with a shorter time to hemostasis and time to ambulation but not less bleeding. Further study of patients with high-bleeding risk is required, including women, patients with chronic kidney disease, and those using high-potency P2Y12 inhibitors. Registration URL: https://clinicaltrials.gov/ct2/show/NCT01848106; Unique identifier: NCT01848106.

Abstract

BACKGROUND Blood loss and incision-related complications caused by the surgical procedure to release gluteal muscle contracture (GMC) put negative effects on the surgical outcomes. Current procedures to prevent blood loss and complications are not satisfactory. The current study aimed to determine whether tranexamic acid (TXA) in combination with pressure dressing reduce the amount of blood loss, the rate of incision-related complications, and the rate of readmission for patients undergoing surgeries to release GMC. METHODS 49 GMC patients were finally included in the study and were randomly divided into two groups: study group and control group. Patients in both groups received minimally invasive surgery to release GMC except that in the study group, patients were administered a dosage of 20 mg/kg of intravenous TXA preoperatively, and 2 subsequent dosages of TXA at 10 mg/kg at two time points: 3 and 6 h after the first dose. Gauze soaked with TXA was used to pack the wound for 10 min before the incision closure. Then the wound was pressure-wrapped with a hip-spica bandage for 24 h after the surgery in the study group. RESULTS The level of UBL in the study group was significantly lower compared to that in the control group. Similar results were also found for UMHD and UMAD. The incision-related postoperative complications were greatly decreased in the study group compared to those of the control group as well. So was the 30-day readmission rate. All patients in both groups reached "excellent" or "good" level with respect to the postoperative function evaluation. CONCLUSIONS Intravenous and topical application of TXA combined with 24 h pressure hip-spica bandage reduces perioperative blood loss, rate of incision-related complications, and the rate of readmission for GMC patients undergoing minimally invasive surgical releasing procedure. Trial Registration Chinese Clinical and Trial Registry ChiCTR2000039216, registration date 2020/10/22, retrospectively registered.

Abstract

BACKGROUND The clinical efficacy of platelet-rich plasma (PRP) in the treatment of total joint replacement (TJR) remains inconclusive. In this paper, systematic review and meta-analysis was adopted to assess the efficacy of using PRP for the treatment of TJR. METHODS A comprehensive search of Medline, Embase, and Cochrane library databases for randomized controlled trial (RCT) articles recording data of PRP for TJR was conducted from inception to February 2022. Outcomes concerned were pain, range of motion (ROM), WOMAC score, length of hospital stay (LOS), hemoglobin (Hb) drop, total blood loss, wound healing rate, and wound infection. The methodological quality of the included RCTs was evaluated by using the Cochrane Risk of Bias Tool 2.0 (RoB 2.0). The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) was utilized to assess the level of evidence for the outcomes. Subgroup analysis was conducted according to the type of TJR. RESULTS Ten RCTs were included in the meta-analysis. In the TKA subgroup, the available data demonstrated that there were significant differences in the outcomes of pain and Hb drop, while it was the opposite of ROM, WOMAC score, LOS, total blood loss, wound healing rate, and wound infection. In the THA subgroup, no significant differences could be seen between two groups in the outcomes of LOS and wound infection. However, the PRP group gained a higher wound healing rate in the THA subgroup. CONCLUSION The application of PRP did not reduce blood loss but improved the wound healing rate. However, more prospective and multicenter studies are warranted to confirm these results.

Abstract

BACKGROUND Restrictive blood transfusion is recommended by major guidelines for perioperative management, but requires objective assessment at 7-10 g/dl haemoglobin (Hb). A scoring system that considers the physiological needs of the heart may simply the practice and reduce transfusion. METHODS Patients (14-65 years of age) undergoing non-cardiac surgery were randomised at a 1:1 ratio to a control group versus a Perioperative Transfusion Trigger Score (POTTS) group. POTTS (maximum of 10) was calculated as 6 plus the following: adrenaline infusion rate (0 for no infusion, 1 for ≤0.05 μg·kg(-1) ·min(-1) , and 2 for higher rate), FiO(2) to keep SpO(2) at ≥95% (0 for ≤35%, 1 for 36%-50%, and 2 for higher), core temperature (0 for <38°C, 1 for 38-40°C, and 2 for higher), and angina history (0 for no, 1 for exertional, and 2 for resting). Transfusion is indicated when actual Hb is lower than the calculated POTTS in individual patients. Transfusion in the control group was based on the 2012 American Association for Blood Banks (AABB) guideline. The primary outcome was the proportion of the patients requiring transfusion of allogeneic red blood cells (RBCs) during the perioperative period (until discharge from hospital), as assessed in the intention-to-treat (ITT) population (all randomised subjects). RESULT A total of 864 patients (mean age 44.4 years, 244 men and 620 women) were enrolled from December 2017 to January 2021 (433 in the control and 431 in the POTTS group). Baseline Hb was 9.2 ± 1.8 and 9.2 ± 1.7 g/dl in the control and POTTS groups, respectively. In the ITT analysis, the proportion of the patients receiving allogeneic RBCs was 43.9% (190/433) in the control group versus 36.9% (159/431) in the POTTS group (p = 0.036). Lower rate of allogeneic RBCs transfusion in the POTTS group was also evident in the per-protocol analysis (42.8% vs. 35.5%, p = 0.030). Transfusion volume was 4.0 (2.0, 6.0) and 3.5 (2.0, 5.5) units (200 ml/unit) in the control and POTTS groups, respectively (p = 0.25). The rate of severe postoperative complications (Clavien-Dindo grade IIIa and higher) was 3.9% in the control group versus 1.2% in the POTTS group (p = 0.010). CONCLUSION Transfusion of allogeneic RBCs based on the POTTS was safe and reduced the transfusion requirement in patients undergoing non-cardiac surgery.

Abstract

OBJECTIVE To explore the clinical efficacy and mechanism of compound Shenlu granule (SLG) treatment in patients with aplastic anemia (AA). METHODS A total of 89 AA patients were randomly divided into an SLG supportive group (group A, n = 44) and a control group (group B, n = 45) while continuing Western medical management. After 6 months, hemograms, traditional Chinese medicine (TCM) syndrome scores, and overall clinical efficacy rate were assessed. Serum metabolomics characteristics were observed using ultraperformance liquid chromatography-mass spectrometry after SLG intervention. RESULTS The levels of red blood cell (RBC), hemoglobin (Hb), and platelet (PLT) were increased in both groups after treatment for 6 months (P < 0.05), and in group A, the elevation of PLT became much more significant (P < 0.01). The TCM syndrome score was lower in group A than in group B after treatment (P < 0.05). Metabolomics data showed a significant difference in the patients using SLG after 6 months, and 14 biomarkers were identified. CONCLUSION SLG supportive treatment showed positive results in patients with AA, and metabolomics data indicated that SLG influenced aminoacyl-tRNA biosynthesis and glycerophospholipid metabolism to gradually return to normal.

Abstract

The optimal regimes of tranexamic acid (TXA) and dexamethasone (DXM) in total knee arthroplasty (TKA) are still uncertain. The aim of this study was to assess the efficacy and safety of a prolonged course of intravenous TXA and DXM involving a high initial dose in TKA. Patients who underwent primary TKA at our center were randomized to receive one of four regimes: control (group A), prolonged course of TXA (B), prolonged course of DXM (C), or the combination of a prolonged course of TXA and DXM (D). The four groups were compared in primary outcomes (fibrinolytic and inflammatory markers, knee function, postoperative pain levels, and consumption of opioids) and secondary outcomes (blood loss, maximal drop in hemoglobin, coagulation, fasting blood glucose, and complications). A total of 162 patients were enrolled. On postoperative days 2 and 3, fibrinolytic markers were lower in groups B and D than in groups A and C; inflammatory markers were lower in groups C and D than in groups A and B. Inflammatory markers were lower in group B than in group A on postoperative day 3. Postoperative pain levels and oxycodone consumption were lower, and knee function was better in groups C and D. The four groups did not differ in any of the secondary outcomes. A prolonged course of intravenous TXA and DXM involving high initial doses can effectively inhibit postoperative fibrinolytic and inflammatory responses, reduce pain, and improve knee function after TKA.

Abstract

BACKGROUND To investigate the regenerative effect of adjunctive use of guided tissue regeneration (GTR), bovine porous bone mineral (BPBM) and platelet-rich fibrin (PRF) in intrabony defects. METHODS Fourteen participants were enrolled, and for each patient their left and right 2 sides were randomized to the test group or control group. Only the worst intrabony defect on each side was analyzed. The test group received GTR, BPBM and PRF, while the control group received only GTR and BPBM. The PRF used in the trial was fluid PRF, which combined with the BPBM to form a BPBM-PRF complex. The patients were followed up by clinical and radiographic evaluation for 24 months after surgery. RESULTS Probing depth (PD) in the test group was significantly less than that in the control group at 12 and 24 months after surgery, and the mean difference was approximately 0.5-0.7 mm. Clinical attachment level (CAL) gain in the test group was approximately 0.9 mm higher than that in the control group at 6 months after surgery, and the difference reached 1.0-1.1 mm 12 and 24 months after surgery. None of the other clinical or radiographic parameters differed significantly between the two groups at any time-point after the surgery. CONCLUSION Compared with GTR and BPBM, the combination of GTR and BPBM-PRF complex is more effective clinically, and results in better clinical outcomes. This article is protected by copyright. All rights reserved.

Abstract

OBJECTIVE The aim of this study is to analyze the clinical effect of small bone-window craniotomy with microscope combined postoperative ICP monitoring, and further explore an appropriate treatment for HICH patients. METHODS One hundred fifty patients with HICH were selected according to inclusion and exclusion criteria and divided into 3 groups at random, 50 each group. Patients in 3 groups were treated with conventional craniotomy, small bone-window craniotomy and small bone-window craniotomy combined ICP monitoring respectively. The surgical efficiency, treatment effect and outcomes were recorded and analyzed. RESULTS The intraoperative blood loss and operation time of small window groups were significantly less than that of conventional group, and the hematoma clearance rate in small window groups were significantly higher than in conventional group (P < 0.05). Compared with conventional group, the hospital stays and mannitol dose used were less in small window groups and least in small window combined ICP monitoring group (P < 0.05). The complication rate in small window combined ICP monitoring group was 10%, which was significantly lower than in conventional group (26%, P < 0.05), while no significant difference was found between small window group (18%) compared with the other 2 groups respectively (P > 0.05). The difference of morality rate between 3 groups wasn't significant (P > 0.05). Three treatment significantly increased the Barthel index score, and the improvement of small window combined ICP monitoring group was significantly higher than in other 2 groups respectively (P < 0.05), while the difference between this two groups wasn't significant (P > 0.05). CONCLUSION Small bone-window craniotomy is more efficient and convenient than conventional craniotomy in the treatment of HICH. In the meantime, small bone-window craniotomy simultaneous with ICP monitoring significantly improved clinical effect and treatment outcomes of HICH patients.

Abstract

BACKGROUND Rates and predictors of major bleeding in patients with peripheral artery disease (PAD) treated with antiplatelets have not been well studied. This post hoc analysis of EUCLID aimed to determine the incidence of major/minor bleeding, predictors of major bleeding, and risk of major adverse cardiovascular events (MACE) following major bleeding events. METHODS EUCLID, a multicenter randomized controlled trial of 13,885 patients with symptomatic PAD, compared ticagrelor with clopidogrel for the prevention of MACE. The primary safety end point was Thrombolysis in Myocardial Infarction (TIMI) major bleeding. Baseline characteristics were used to develop a multivariable model to determine factors associated with TIMI major bleeding. The occurrence and timing of MACE relative to a first major bleeding event were determined. RESULTS TIMI major bleeding occurred in 2.3% of participants overall (0.94 event/100 patient-years). There was no significant difference in major bleeding rates by treatment assignment. Factors associated with TIMI major bleeding included older age, geographic region, Rutherford class, and beta-blocker use. Patients with TIMI major bleeding postrandomization had an increased risk of MACE (hazard ratio [HR] 4.46; 95% CI 3.40-5.84; P<.0001) compared with those without major bleeding; the association was strongest within 30days after a bleeding event. CONCLUSIONS In patients with symptomatic PAD, 0.94 major bleeding event/100 patient-years was observed and associated with older age, residing in North America, disease severity, and beta-blocker use. Patients who had a major bleeding event were significantly more likely to experience MACE, especially within the first 30days, when compared with patients who did not have major bleeding.

Abstract

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.