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Fibrin Glue Sac Filling for Preventing Type II Endoleak, Short-Term Outcomes of a Prospective Randomized Controlled Trial
Chen Y, Zhang L, Liu Z, Bi J, Niu F, Zhang X, Lu Q, Dai X
Journal of endovascular therapy : an official journal of the International Society of Endovascular Specialists. 2023;:15266028231159245
Abstract
OBJECTIVE Type II endoleak (T2EL) worsens the long-term results of endovascular aneurysm repair (EVAR). How to prevent T2ELs remains controversial. This study aimed to evaluate the efficacy and safety of fibrin glue sac filling (FGSF) to prevent T2ELs after EVAR. METHODS A prospective randomized controlled trial was conducted. Patients were randomly divided into group A (standard EVAR + FGSF) and group B (standard EVAR). The follow-up plans included outpatient or telephone consultation at 1 and 3 months and computed tomography (CT) angiography at 6 months, 1 year, and once a year after EVAR. RESULTS A total of 64 abdominal aortic aneurysm (AAA) patients were randomized to the 2 groups. All patients were followed up for more than 6 months. The 2 groups showed similar baseline characteristics. The rate of T2ELs on immediate angiography in group A (9.6%) was significantly lower than that in group B (33.3%, p=0.033). Moreover, the sac area change was significantly reduced in group A at 6 months after EVAR (p=0.021). However, T2EL incidence was similar at the 6-month (p=0.055) and 1-year (p=0.057) follow-ups, and AAA diameter change was also similar at 1 year. There were similar operation times, radiation doses, severe adverse events (SAEs), and reinterventions between the 2 groups. CONCLUSION Fibrin glue sac filling could prevent short-term type II endoleaks and promote AAA shrinkage after 6 months. The FGSF procedure is swift and straightforward; however, patients are at risk of bowel ischemia, especially after previous bowel resections or concomitant superior mesenteric artery (SMA) disease. CLINICAL IMPACT Standard endovascular aneurysm repair (EVAR) couldn't prevent type II endoleak (T2EL). In this study, we found fibrin glue sac filling (FGSF) could prevent T2EL and promote AAA shrinkage in a short term. And the FGSF procedure is easy, it will be a useful supplement to standard EVAR for clinicians. And FGSF might have potential usefulness on ruptured aneurysms, although without direct evidence.Fibrin glue is often used to hemostasis and tissue adhesion in surgical patients and burn patients, we firstly carry out a randomized controlled study and prove that fibrin glue sac filling could prevent T2EL and promote sac remodeling.
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Endoscopic Delivery of Polymers Reduces Delayed Bleeding after Gastric Endoscopic Submucosal Dissection: A Systematic Review and Meta-Analysis
Chen Y, Zhao X, Wang D, Liu X, Chen J, Song J, Bai T, Hou X
Polymers. 2022;14(12)
Abstract
New endoscopic approaches for the prevention of delayed bleeding (DB) after gastric endoscopic submucosal dissection (ESD) have been reported in recent years, and endoscopic delivery of biodegradable polymers for iatrogenic ulcer hemostasis and coverage has emerged as one of the most promising techniques for post-ESD management. However, the comparative efficacy of these techniques remains uncertain. We performed a systematic search of multiple databases up to May 2022 to identify studies reporting DB rates as outcomes in patients undergoing gastric ESD who were treated with subsequent endoscopic management, including endoscopic closure (clip-based methods and suturing), PGA sheet tissue shielding, and hemostatic powder/gel spray (including polymeric sealants and other adhesives). The risk ratios (RRs) of delayed bleeding in treatment groups and control groups were pooled, and the Bayesian framework was used to perform a network meta-analysis (NMA). Among these studies, 16 head-to-head comparisons that covered 2742 lesions were included in the NMA. Tissue shielding using PGA sheets significantly reduced the risk of DB by nearly two thirds in high-risk patients, while hemostatic spray systems, primarily polymer-based, reduced DB in low-risk patients nine-fold. Researchers should recognize the essential role of polymers in the management of ESD-induced ulcers, and develop and validate clinical application strategies for promising materials.
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An alternative method for personalized tourniquet pressure in total knee arthroplasty: a prospective randomized and controlled study
Wu J, Fu Q, Li H, Han Y, Deng J, Chen Y, Qian Q
Scientific reports. 2022;12(1):9652
Abstract
Tourniquet use always carries potential risks, which can range from mild transient functional impairments of thigh pain, skin blisters to severe permanent dysfunction of limb paralysis, nerve injuries or compartment syndrome. The ideal method for minimizing intraoperative tourniquet pressure (TP) for reducing postoperative complications remains controversial. In this prospective, randomized and controlled study, we reinvestigated an estimation formula for TP based on thigh circumferences and systolic blood pressure (SBP) with two traditional methods for TP determination in total knee arthroplasty (TKA): SBP plus 100 mmHg and a fixed value of 300 mmHg. TP values and postoperative thigh pain scores were compared among three groups. The intraoperative TP value of the formula-calculated group was lower than that of the traditional groups (14.7 mmHg, Pā=ā0.3475 and 94.7 mmHg, Pā<ā0.0001, respectively), while no differences of hemostatic effect at the surgical fields and wound complications were detected among groups. The thigh pain scores at the tourniquet site decreased gradually over time and the estimation group had the lowest scores at each timepoint after surgery. Estimation method for TP was easy and rapid, without relying on specific equipment. It could provide a practical low TP and comparable hemostatic effect in TKA using an inflating tourniquet.
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Regular bleeding risk assessment associated with reduction in bleeding outcomes: The mAFA II randomised trial
Guo Y, Lane DA, Chen Y, Lip GYH
Am J Med. 2020
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Editor's Choice
Abstract
BACKGROUND The mobile Atrial fibrillation application (mAFA-II) randomised trial reported that a holistic management strategy supported by mobile Health reduced atrial fibrillation-related adverse outcomes. The present study aimed to assess whether regular reassessment of bleeding risk using the HAS-BLED score would improve bleeding outcomes and anticoagulant (OAC) uptake. METHODS Bleeding risk (HAS-BLED score) was monitored prospectively using mAFA, and calculated as 30 days, Days 31-60, Days 61-180, and Days 181-365. Clinical events and OAC changes in relation to the dynamic monitoring were analysed. RESULTS We studied 1793 patients with atrial fibrillation (mean, standard deviation, age 64, 24 years, 32.5% female). Comparing baseline and 12 months, the proportion of atrial fibrillation patients with HAS-BLED ≥3 decreased (11.8% vs. 8.5%, p=0.008), with changes in use of concomitant NSAIDs/antiplatelets, renal dysfunction, and labile international normalized ratio contributing to the decreased proportions of patients with HAS-BLED ≥3 (p<0.05). Among 1077 (60%) patients who had four bleeding risk assessments, incident bleeding events decreased significantly from Days 1-30, to Days 181-365 (1.2% to 0.2%, respectively, p<0.001). Total OAC usage increased from 63.4% to 70.2% (ptrend<0.001). Compared to atrial fibrillation patients receiving usual care (n=1136), bleeding events were significantly lower in atrial fibrillaiton patients with dynamic monitoring of their bleeding risk (mAFA vs usual care, 2.1%, 4.3%, p=0.004). (p<0.001). CONCLUSION Dynamic risk monitoring using the HAS-BLED score, together with holistic App-based management using mAFA II reduced bleeding events, addressed modifiable bleeding risks and increased uptake of OACs.
PICO Summary
Population
Patients with atrial fibrillation enrolled in the mAFA-II trial (n=1793).
Intervention
Dynamic risk monitoring on anticoagulant and bleeding events using the HAS-BLED score at four timepoints (n=1077).
Comparison
Usual care (n=1136).
Outcome
Comparing baseline and 12 months, the proportion of atrial fibrillation patients with HAS-BLED >/=3 decreased (11.8% vs. 8.5%), with changes in use of concomitant NSAIDs/antiplatelets, renal dysfunction, and labile international normalized ratio contributing to the decreased proportions of patients with HAS-BLED >/=3. Among 1077 (60%) patients who had four bleeding risk assessments, incident bleeding events decreased significantly from Days 1-30, to Days 181-365 (1.2% to 0.2%, respectively). Total OAC usage increased from 63.4% to 70.2%. Compared to atrial fibrillation patients receiving usual care (n=1136), bleeding events were significantly lower in atrial fibrillation patients with dynamic monitoring of their bleeding risk (mAFA vs usual care, 2.1%, 4.3%).
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The efficacy of bipolar sealer on blood loss in spine surgery: a meta-analysis
Lan T, Hu SY, Yang XJ, Chen Y, Qiu YY, Guo WZ, Lin JZ., Ren K
European Spine Journal : Official Publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society. 2017;26((7):):1796-1802
Abstract
OBJECTIVE The purpose of this meta-analysis of randomized controlled trials (RCTs) and non-RCTs was to gather data to evaluate the efficacy and safety of bipolar sealer versus standard electrocautery in the management of spinal disease. METHODS The electronic databases including Embase, PubMed and Cochrane library were searched to identify relevant studies published from the time of the establishment of these databases up to January 2017. The primary outcomes were total blood loss, requirement of transfusion (rate and amount), and operation time. The secondary outcomes were length of hospital stay and postoperative wound infection. Data analysis was conducted with RevMan 5.3 software. RESULTS A total of five studies involving 500 patients (261 patients in the BS group and 239 in the control group) were included in the meta-analysis. The pooled results revealed that application of bipolar sealer could decrease the total blood loss in spine surgery [WMD = -467.49, 95% CI (685.47 to -249.51); p < 0.05; I 2 = 91%]. Compared with standard electrocautery, bipolar sealer was associated with lower rates of need for transfusion [OR = 0.30, 95% CI (0.16-0.55), p < 0.05; I 2 = 0%]. In addition, patients in the BS group were likely to receive less amount of blood transfusion compared with patients in the control group[WMD = -0.73, 95% CI (-1.37 to -0.09), p < 0.05; I 2 = 76%]. The mean operative time was shorter in the BS groups compared with the control group [SMD = -0.36, 95% CI (-0.60 to -0.13), p < 0.05; I 2 = 0%]. There was no significant difference in terms of length of hospital stay [WMD = -0.73, 95% CI (-1.96 to 0.51), p = 0.25; I 2 = 67%] and postoperative wound infection [OR = 0.88, 95% CI (0.31-2.48), p = 0.81; I 2 = 0.0%] between both groups. CONCLUSIONS The available evidence suggests that bipolar sealer is superior to standard electrocautery with less blood loss, shorter operation time and less transfusion requirement. There is no significant difference between both groups regarding length of hospitalization and wound infection. Hence, bipolar sealer is recommended in spine surgery. Because of the limitation of our study, more well-designed RCTs with large sample are required to provide further evidence of safety and efficacy between bipolar sealer and standard electrocautery in the treatment of spinal disease.