Ultrafiltration in cardiac surgery: Results of a systematic review and meta-analysis
Hensley, N. B., Colao, J. A., Zorrilla-Vaca, A., Nanavati, J., Lawton, J. S., Raphael, J., Mazzeffi, M. A., Wierschke, C., Kostibas, M. P., Cho, B. C., et al
Background: Ultrafiltration is used with cardiopulmonary bypass to reduce the effects of hemodilution and restore electrolyte balance. We performed a systematic review and meta-analysis to analyze the effect of conventional and modified ultrafiltration on intraoperative blood transfusion.Methods: Utilizing the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) statement, we systematically searched MEDLINE, EMBASE, Web of Science, and Cochrane Library to perform a meta-analysis of studies of randomized controlled trials (RCTs) and observational studies evaluating conventional ultrafiltration (CUF) and modified ultrafiltration (MUF) on the primary outcome of intraoperative red cell transfusions.Results: A total of 7 RCTs (n = 928) were included, comparing modified ultrafiltration (n = 473 patients) to controls (n = 455 patients) and 2 observational studies (n = 47,007), comparing conventional ultrafiltration (n = 21,748) to controls (n = 25,427). Overall, MUF was associated with transfusion of fewer intraoperative red cell units per patient (n = 7); MD -0.73 units; 95% CI -1.12 to -0.35 p = 0.04; p for heterogeneity = 0.0001, I(2) = 55%) compared to controls. CUF was no difference in intraoperative red cell transfusions compared to controls (n = 2); OR 3.09; 95% CI 0.26-36.59; p = 0.37; p for heterogeneity = 0.94, I(2) = 0%. Review of the included observational studies revealed an association between larger volumes (>2.2 L in a 70 kg patient) of CUF and risk of acute kidney injury (AKI).Conclusion: The results of this systematic review and meta-analysis suggest that MUF is associated with fewer intraoperative red cell transfusions. Based on limited studies, CUF does not appear to be associated with a difference in intraoperative red cell transfusion.
Effects of Shared Decision Making with Patient Decision Aid for Post-Angiography Hemostasis Method Selection: A Randomized Controlled Trial
Huang YC, Kao CC, Lu YH, Chou YY, Lin YK, Tam KW
Journal of vascular and interventional radiology : JVIR. 2023
PURPOSE To evaluate the effects of shared decision-making (SDM) with patient decision aid (PtDA) on hemostasis device selection and reduction of decisional conflicts in patients undergoing transfemoral angiography. MATERIALS AND METHODS Patients undergoing angiography were randomized to receive either a standard explanation or the process aid of PtDA for choosing hemostasis devices. The decisional conflict was assessed using the 4-item SURE (Sure of myself; Understand information; Risk-benefit ratio; Encouragement) scale. Differences in demographic variables, clinical variables, and final choice of hemostasis devices were compared through univariable and multivariable logistic regression analyses. RESULTS In total, 158 patients were included-80 in the PtDA group and 78 in the standard group. No difference was found between the two groups in terms of patient demographic and clinical variables. The PtDA group scored better on all questions of the SURE scale both individually and collaboratively (P < .001). PtDA intervention (P = .031) and the reason for angiography (P = .0006) were the main variables that influenced patient hemostasis device choice in the univariable logistic regression analysis. Reason for angiography remained the only deciding factor that affected patient choice in multivariable logistic regression analysis (P = .015). CONCLUSIONS Step-by-step guidance and pictorial explanation with the assistance of PtDA led to improvements in patient knowledge but show no significant impact in multivariate analysis for the influence on the choice of hemostasis device. Implementation of PtDA-aided SDM is recommended for improving patient-centered care.
Efficacy of Harmonic Scalpel Versus Bipolar Diathermy in Hemorrhoidectomy: A Systematic Review and Meta-Analysis of Nine Randomized Controlled Trials
Albazee, E., Alenezi, A., Alenezi, M., Alabdulhadi, R., Alhubail, R. J., Ahmad Al Sadder, K., AlDabbous, F., Almutairi, A. N., Almutairi, S. N., Almutairi, A. N., et al
Hemorrhoidectomy is one of the most common surgical interventions to remove the third and fourth degrees of prolapse hemorrhoid. We carried out this systematic review and meta-analysis of the randomized controlled trials (RCTs) to comprehensively evaluate the efficacy of harmonic scalpel (HS) versus bipolar diathermy (BD) methods in terms of decreasing intraoperative and postoperative morbidities among patients undergoing hemorrhoidectomy. Suitable citations were found utilizing digital medical sources, including the CENTRAL, Web of Science, PubMed, Scopus, and Google Scholar, from inception until December 2022. Only RCTs that matched the inclusion requirements were selected. We used the updated Cochrane risk of bias (ROB) tool (version 2) to assess the quality of the involved citations. The Review Manager (version 5.4 for Windows) was used to perform the pooled analysis. Data were pooled and reported as mean difference (MD) or risk ratio (RR) with a 95% confidence interval (CI) in random-effects models. Overall, there was no significant difference between HS and BD in terms of decreasing intraoperative morbidities like operative time, intraoperative blood loss, mean duration of hospital stay, and mean duration of first bowel movement (P>0.05). Similarly, the rate of postoperative complications like pain, bleeding, urinary retention, anal stenosis, flatus incontinence, and wound edema; was similar in both groups with no significant difference (P>0.05). In conclusion, our pooled analysis revealed there was no substantial difference between HS and BD in terms of intraoperative and postoperative endpoints. Additional RCTs with larger sample sizes are needed to consolidate the power and quality of the presented evidence.
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
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.
Comparison of post-operative bleeding incidence in laser hemorrhoidoplasty with and without hemorrhoidal artery ligation: a double-blinded randomized controlled trial
Lim SY, Rajandram R, Roslani AC
BMC surgery. 2022;22(1):146
INTRODUCTION The effectiveness of hemorrhoidal artery ligation supplementation in reducing the incidence of post laser hemorrhoidoplasty bleeding has not been investigated. METHODS This was a double-blind, randomized controlled trial comparing post-operative bleeding incidence in patients undergoing laser hemorrhoidoplasty (LHP) only versus LHP with hemorrhoidal artery ligation (HAL). Outcome measures included post-operative bleeding and its severity (i.e. verbal rating scale and Clavien-Dindo classification), presence of perianal swelling and pain score (visual analog score) at 1-day, 1-week and 6-weeks post-operatively. Statistical tests were performed and a value of P < 0.05 was considered significant. RESULTS Seventy-six patients were randomized. There was no difference in median operating time. The bleeding incidence was highest at 1-week post-operatively (17.1%), and decreased to 1.3% at 6-weeks. There was no significant difference in bleeding incidence between both groups at any of the measured timepoints (P > 0.05). Severity of bleeding and incidence of post-operative perianal swelling were similar in both groups (P > 0.05). There was no difference in median pain scores. CONCLUSION Supplementation of HAL to LHP does not reduce the post-operative bleeding incidence. LHP is sufficient as a stand-alone procedure for treating haemorrhoids. TRIAL REGISTRATION National Registration Number is NMRR-15-1112-24065 (IIR). The trial start date was 1st January 2015 with the ClinicalTrials.gov identifier and registration number as NCT04667169.
Comparison of Suture-Based and Collagen-Based Vascular Closure Devices for Large Bore Arteriotomies-A Meta-Analysis of Bleeding and Vascular Outcomes
Sohal S, Mathai SV, Nagraj S, Kurpad K, Suthar K, Mehta H, Kaur K, Wasty N, Waxman S, Cohen M, et al
Journal of cardiovascular development and disease. 2022;9(10)
BACKGROUND Large bore access procedures rely on vascular closure devices to minimize access site complications. Suture-based vascular closure devices (S-VCD) such as ProGlide and ProStar XL have been readily used, but recently, newer generation collagen-based vascular closure devices (C-VCD) such as MANTA have been introduced. Data on comparisons of these devices are limited. METHODS PubMed, Scopus and Cochrane were searched for articles on vascular closure devices using keywords, ("Vascular closure devices" OR "MANTA" OR "ProStar XL" OR "ProGlide") AND ("outcomes") that resulted in a total of 875 studies. Studies were included if bleeding or vascular complications as defined by Valve Academic Research Consortium-2 were compared between the two types of VCDs. The event level data were pooled across trials to calculate the Odds Ratio (OR) with 95% CI, and analysis was done with Review Manager 5.4 using random effects model. RESULTS Pooled analyses from these nine studies resulted in a total of 3410 patients, out of which 2855 were available for analysis. A total of 1229 received C-VCD and 1626 received S- VCD. Among the patients who received C-VCD, the bleeding complications (major and minor) were similar to patients who received S-VCD ((OR: 0.70 (0.35-1.39), p = 0.31, I(2) = 55%), OR: 0.92 (0.53-1.61), p = 0.77, I(2) = 65%)). The vascular complications (major and minor) in patients who received C-VCD were also similar to patients who received S-VCD ((OR: 1.01 (0.48-2.12), p = 0.98, I(2) = 52%), (OR: 0.90 (0.62-1.30), p = 0.56, I(2) = 35%)). CONCLUSIONS Bleeding and vascular complications after large bore arteriotomy closure with collagen-based vascular closure devices are similar to suture-based vascular closure devices.
Comparison of Application Effects of Different Hemostasis Methods After Ischemic Cerebrovascular Intervention
Zhou Y, Xu C
Frontiers in surgery. 2022;9:850139
OBJECTIVE To explore the effects of two different hemostasis methods, namely, arterial compression devices and vascular closure devices, in the ischemic cerebrovascular intervention to provide a theoretical basis for clinical selection of hemostasis methods. METHODS A total of 302 patients who underwent ischemic cerebrovascular intervention in our hospital from January 2016 to December 2020 were selected as the research subjects and randomly divided into the control group (n = 151) and the observation group (n = 151). The patients in both groups underwent cerebrovascular intervention. The patients in the control group were treated with an artery compressor for hemostasis after the operation, while those in the observation group were treated with vascular closure devices for hemostasis. The hemostatic indexes and vascular parameters at the puncture site before and after the operation were compared between the two groups. The comfort level of the patients was assessed at 6, 12, and 24 h after the operation with the Kolcaba Comfort Scale score, and the postoperative complications were recorded. RESULTS There was no significant difference in the success rate of hemostasis between the two groups (p > 0.05). The hemostatic time and immobilization time of (2.69 ± 0.62) min and (4.82 ± 0.93) h in the observation group were lower than those in the control group with (16.24 ± 3.58) min and (7.94 ± 1.86) h (p < 0.05). The differences in the minimum inner diameter of the puncture site and its nearby vessels and the peak velocity of blood flow between the two groups before and after the operation were not statistically significant within or between groups (p > 0.05). The scores of the Kolcaba comfort scale in the observation group (80.16 ± 8.49) and (93.65 ± 9.26) at 6 and 12 h, respectively, after the operation, were higher than those in the control groups (72.08 ± 7.54) and (85.49 ± 8.63) (p < 0.05). The 24 h postoperative Kolcaba comfort scale score was (97.54 ± 9.86) in the observation group and (96.82 ± 9.64) in the control group, and the difference was not statistically significant (p > 0.05). In the control group, there were 7 cases of dysuria, 12 cases of low back pain, 14 cases of sleep disorder, 20 cases of mental stress, and 5 cases of wound bleeding, and the total incidence of complications was 38.41% (58/151). In the observation group, there were 4 cases of dysuria, 8 cases of low back pain, 10 cases of sleep disorder, 14 cases of mental stress, and 3 cases of wound bleeding, and the total incidence of complications was 25.83% (39/151). The total incidence of complications in the observation group was lower than that in the control group (p < 0.05). CONCLUSION For patients with ischemic cerebrovascular disease undergoing femoral artery puncture intervention, the use of vascular closure devices can stop the bleeding quickly, which can significantly shorten the bleeding time, and the postoperative braking time of patients is short, with high comfort and fewer complications.
Rubber band ligation versus coagulation for the treatment of haemorrhoids: a meta-analysis of randomised controlled trials
Ding Z, Xuan J, Tang G, Shi S, Liang X, An Q, Wang F
Postgraduate medical journal. 2022
Non-surgical therapies have the advantage of lower postoperative pain and complication rates compared with surgical therapies. Rubber band ligation and coagulation are two kinds of non-surgical therapies. The aim of this study is to compare the clinical outcomes of rubber band ligation and coagulation. A systematic review was conducted to identify randomised clinical trials that compare rubber band ligation and coagulation treatments for haemorrhoids. PubMed and Web of Science were searched, from inception to April 30th,2022. Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were followed. Fifty-nine studies were identified. Nine trials met the inclusion criteria. All trials were of moderate methodological quality. No significant difference was found between rubber band ligation and coagulation in terms of efficacy rate, postoperative prolapse rate, recurrence rate and postoperative urine retention rate after treatment. Patients undergoing rubber band ligation had higher postoperative pain rate and lower postoperative bleeding rate than patients undergoing coagulation. The subgroup analysis showed that there was no significant difference between rubber band ligation and infrared coagulation or non-infrared coagulation in terms of efficacy rate, postoperative bleeding and postoperative urine retention rate after treatment. Patients undergoing rubber band ligation had a higher postoperative pain rate than patients undergoing infrared coagulation or non-infrared coagulation. We believe that coagulation for haemorrhoids still has a good future. PROSPERO registration number CRD42022311281.
Radial versus femoral access in ACS patients undergoing complex PCI is associated with consistent bleeding benefit and no excess of risks
Landi A, Branca M, Vranckx P, Leonardi S, Frigoli E, Heg D, Calabro P, Esposito G, Sardella G, Tumscitz C, et al
The Canadian journal of cardiology. 2022
BACKGROUND The comparative effectiveness of transradial (TRA) compared with transfemoral access (TFA) in acute coronary syndrome (ACS) patients undergoing complex percutaneous coronary intervention (PCI) remains unclear. METHODS Among 8,404 ACS patients in the Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX (MATRIX)-Access trial, 5,233 underwent noncomplex (TRA, n=2,590 and TFA, n=2,643) and 1,491 complex PCI (TRA, n=777 and TFA, n=714). Co-primary outcomes were major adverse cardiovascular events (MACE, the composite of all-cause mortality, myocardial infarction, or stroke) and the composite of MACE and BARC type 3-5 bleeding (net adverse cardiovascular events, NACE) at 30 days. RESULTS Rates of 30-day MACE (hazard ratio [HR]:0.94; 95% confidence interval [CI]:0.72-1.22) or NACE (HR:0.89; 95% CI:0.69-1.14) did not significantly differ between groups in the complex PCI group, whereas both primary endpoints were lower (HR:0.84; 95% CI:0.70-1.00, HR:0.83; 95% CI:0.70-0.98, respectively) with TRA among noncomplex PCI patients, with negative interaction testing (P(int) 0.473 and 0.666, respectively). Access-site BARC type 3 or 5 bleeding was lower with TRA, consistently among complex (HR:0.18; 95% CI:0.05-0.63) and noncomplex (HR:0.41; 95% CI:0.20-0.85) PCI patients, whereas the former group had a greater absolute risk reduction of 1.7% (number needed to treat: 59) due to their higher absolute risk. CONCLUSIONS Among ACS patients, PCI complexity does not affect the comparative efficacy and safety of TRA versus TFA, whereas the absolute risk reduction of access-site major bleeding was greater with TRA compared with TFA in complex as opposed to noncomplex PCI.
Study on the Safety of the New Radial Artery Hemostasis Device
Wu, B., Zhang, R., Liang, C., Zhang, C., Qin, G.
Journal of Interventional Cardiology. 2022;2022:2345584
OBJECTIVE At present, the use of particular radial hemostatic devices after coronary angiography (CAG) or percutaneous coronary intervention (PCI) has become the primary method of hemostasis. Most control studies are based on the products already on the market, while only a few studies are on the new hemostatic devices. The aim of this study is to compare a new radial artery hemostasis device which is transformed based on the invention patent (Application number: CN201510275446) with TR Band (Terumo Medical) to evaluate its clinical effects. METHODS In a prospective randomized clinical trial, 60 patients after CAG or PCI were randomly divided into two groups, patients in the trial group (CD group) using a new radial artery hemostasis device to stop bleeding and the control group (TR group) using the TR Band. The method is to collect relevant data of the two groups and compare the differences in hemostasis, local complications, and patient discomfort between the two groups. RESULTS The hemostatic devices in both groups achieved adequate hemostasis, and there was no failure to stop bleeding. The new radial artery hemostasis device was better than the TR band in pain and swelling (P < 0.05). There were no significant differences in bleeding, hematoma, ecchymosis, skin damage, and local infection between the two groups (P > 0.05). CONCLUSIONS The sample of the new radial artery hemostasis device can stop bleeding effectively at the puncture site after CAG or PCI and is not inferior to the TR Band balloon hemostatic device in safety and is better in comfort.