Hemostasis Time Research Articles

Tie or do not tie: comparing knot tying hemostasis in tonsillectomy with other methods of hemostasis. A systematic review and meta-analysis.

This meta-analysis sought to compare knot tying against other methods of haemostasis in terms of post-operative haemorrhage, intraoperative blood loss and tonsillectomy time. Two independent reviewers performed a literature search according to PRISMA guidelines. Three databases were consulted, Pubmed, Google Scholar and Embase. Studies comparing knot tying with any other form of tonsillectomy haemostasis were included. Six studies met inclusion criteria for meta-analysis, comprising 1764 patients. When comparing knot tying with other forms of haemostasis there was no significant difference in terms of post-operative haemorrhage rates (odds ratio) (OR: 2.31, 95% CI 0.37to14.28, P = 0.37, I2 = 81%). There was significantly less intraoperative blood loss when haemostasis methods other than knot tying were used for tonsillectomy (OR: - 1.66, 95% CI: - 2.64 to - 0.69, P < 0.0008, I2=97%). haemostasis time was significantly shorter without knot tying (OR: - 1.49, 95% CI: - 2.61 to - 0.36, P < 0.01, I2 = 97%) as was total operation time (OR: - 1.93, 95% CI: - 3.61 to - 0.23, P < 0.03, I2 = 97%). Tonsillectomy is one of the oldest operations and traditional tonsil surgery has preceded the advent of evidence-based practice. Tie ligation of bleeding vessels is an effective method of securing intraoperative haemostasis and a skill all surgeons should be competent in. Our systematic review and meta-analysis found no evidence to support knot tying of tonsils to prevent post tonsillectomy bleeding compared to any haemostatic intervention during any method of tonsillectomy.

Post-closure Technique for Access Hemostasis During Emergency Endovascular Repair in Ruptured Abdominal Aortic Aneurysms: Technical Note on a Preliminary Experience.

To describe the downsizing post-closure technique for access hemostasis during emergency endovascular repair (EVAR) in ruptured abdominal aortic aneurysms (RAAA). A cohort of eight patients underwent emergency EVAR through 16 femoral access sites for infrarenal RAAA. The downsizing post-closure technique, which involves a reduction in the size of the large-bore access by advancing a 10F sheath, was consistently applied. Technical success was defined as complete hemostasis without a bailout intervention. Primary outcome measure was the incidence of access-related complications. Secondary outcome measures included manual compression time, hemostasis time, hospital stay, additional use of Proglide, and the 30-day mortality rate. The techniqueresulted in a 100% success rate (mean age: 69.5 ± 11.7years; 75% males). The mean arterial sheath size was 18.1 ± 1.9F. The mean manual compression time was 3.6 ± 1.2min, and the mean hemostasis time was 6.8 ± 1.4min. No patients required additional use of Proglide, and no access-related complications were observed. The 30-day mortality rate was 12.5%. The downsizing post-closure technique may offer an alternative for access hemostasis during emergency EVAR for RAAA. However, further evaluations through larger comparative studies are required.

Mussel-inspired oxidized sodium alginate/cellulose composite sponge with excellent shape recovery and antibacterial properties for the efficient control of non-compressible hemorrhage

Enhancing the hemostatic efficacy and minimizing blood loss in the body has consistently been a primary objective for researchers. This study improved the hemostatic efficacy and tissue adhesion strength of the hemostatic material by augmenting the aldehyde groups in the side chains of sodium alginate. Additionally, it immobilized the aldehyde-modified sodium alginate onto the surface of the hemostatic material through complexation with iron ions, thereby enhancing its antibacterial properties. The mechanical performance results demonstrated that the composite hemostatic sponge can rapidly absorb water, swell to counteract arterial blood pressure, and seal the bleeding wound. The results of tissue and blood cell adhesion and in vivo hemostasis showed that the composite hemostatic sponge can enhance the rate of blood clot formation and the adhesion strength of tissue, thereby reducing the hemostasis time and blood loss. The bacterial and cell growth results demonstrated that the composite hemostatic sponge displays excellent biocompatibility and antibacterial properties. Based on the excellent water absorption, swelling properties, and softness of cellulose sponge, the composite hemostatic sponge offered a significant advantage for achieving rapid hemostasis in penetrating wounds or deep wounds with substantial bleeding.

Traditional Versus Distal Radial Access for Coronary Diagnostic and Revascularization Procedures: Final Results of the TENDERA Multicenter, Randomized Controlled Study.

Traditional transradial access (TRA) is widely used for coronary and non-coronary interventions with significant improvements in procedural outcomes; however, it is associated with RAO that precludes repeat use of the same artery for possible future TRI and other purposes. Distal radial access (DRA) has been proposed as an effective alternative to decrease RAO rates. Published literature describing the RAO rate after DRA versus TRA from various RCT and clinical registries has shown conflicting results. This study compared the forearm radial artery occlusion (RAO) rate assessed by Doppler ultrasound between distal and conventional radial access at 1-year follow-up after the initial procedure. TENDERA was a multicenter, randomized controlled study comparing DRA versus TRA for coronary diagnostic and interventional procedures using 5 or 6F hydrophilic-coated sheaths. The primary endpoint was forearm RAO at 12 months after radial access. The secondary endpoints included puncture time, sheath insertion and total procedure time, radiation dose, and vascular access site-related complications. Eight hundred and fifty patients were randomized to either TRA (n = 418) and DRA (n = 432) groups. In the intention-to-treat analysis, the rate of forearm RAO at 12 months was observed in 39 patients (4.6%) and was significantly reduced in the DRA group compared with the TRA group (2.5% vs. 6.7%, RR 2.59 [95% CI 1.29-5.59], p = 0.010). Analysis in per protocol population has shown consistent results with forearm RAO rate 2.8% in the DRA group versus 6.5% in the TRA group (p = 0.008). The crossover rate was higher (4.6% vs. 1%, p = 0.013) and median hemostasis time was shorter (156.5 min vs. 180 min, p < 0.001) with DRA. Overall bleeding (BARC 1-2) and postprocedure hematoma > 5 cm occurred less frequently in the DRA group compared with the TRA group (3.2% vs. 20.5%, p < 0.001% and 9.0% vs. 27.0%, p < 0.001, respectively). No significant differences were observed in total procedure time and radiation dose between groups. DRA for coronary diagnostic and interventional procedures is associated with reduced forearm RAO rate and shorter hemostasis time, but a longer sheath insertion time and higher crossover rate compared with TRA. ClinicalTrials.gov: NCT04211584.

Impact of the thin-walled sheath on the distal radial artery occlusion: a randomized trial

Abstract Background Distal transradial access (dTRA) has been increasingly accepted as an alternative to the transradial access (TRA) for coronary angiography (CAG) and/or percutaneous coronary intervention (PCI). Although the dTRA has been significantly associated with better patient comfort, shorter haemostasis time, and fewer vascular access-related complications, such as haematoma and proximal radial artery occlusion (pRAO), it has also been associated with an increased risk of distal radial artery occlusion (dRAO). Purpose The aim of the present study was to investigate whether the 6-Fr thin-walled sheath was superior to the conventional radial sheath with respect to the incidence of distal radial artery occlusion (dRAO) at 24 h after CAG and/or PCI via dTRA. Methods A prospective, single-centre trial of patients who were randomized to undergo CAG and/or PCI with either a 6-Fr thin-walled sheath or a 6-Fr conventional sheath. The primary endpoint was the incidence of dRAO at 24 h postoperatively, as evaluated by Doppler ultrasound. The second endpoints included the puncture success rate, puncture time, the incidence of pRAO, pain during the sheath placement, and other vascular-associated complications. Results A total of 620 patients were included in the study. The mean age of the patients was 66.6± 9.7 years (median age 69.0 years [interquartile range 60.0- 74.0 years]), and 66.3% were men. The baseline patient and procedural characteristics were similar between the two groups. For the primary endpoint, the incidence of dRAO at 24 h after the procedure was 1.0% (3/314) in the thin-walled sheath group and 3.6% (11/306) in the conventional sheath group (RR= 0.266, 95%CI= 0.075-0.943, P= 0.027) according to the intention-to-treat (ITT) analysis. For secondary endpoints, the incidence of pRAO was 0.3% (1/314) in the thin-walled sheath group and 2.3% (7/306) in the conventional sheath group (P= 0.029). No significant difference was observed between the thin-walled sheath and the conventional sheath groups regarding the puncture success rate (92.4% vs. 92.5%, P= 0.952). The severity of pain experienced during the sheath placement was similar between the two groups (VAS 2 vs. 2 P=0.426). Other secondary endpoints, including procedural outcomes and other puncture-related outcomes and access-related complications, were not significantly different between the two groups. Conclusion A thin-walled sheath can reduce the incidence of early-term dRAO in patients who underwent CAG and/or PCI via the dTRA.The primary endpoint of the trial

Solution-blow spinning halloysite nanotube loaded chitosan-polyethylene oxide fibrous membrane as hemostatic dressings

In this study, chitosan/polyethylene oxide fibrous membranes (CS/PEO) with varying halloysite nanotubes (HNTs) contents were prepared by solution-blow spinning. The HNTs-CS/PEO membranes with a 12 wt% HNTs content exhibited excellent hydrophilicity, air permeability, and flexibility. The in vitro hemostasis time of the 12 % HNTs-CS/PEO was 217 s, and it was observed to form a stable thrombus. Moreover, the antibacterial efficacy of 12 % HNTs-CS/PEO against Escherichia coli and Staphylococcus aureus was 90.05 % and 69.86 %, respectively. Furthermore, the in vitro cytotoxicity study demonstrated the nontoxic nature of the 12 % HNTs-CS/PEO. The solution-blow spinning HNTs-CS/PEO fibrous membrane can potentially prevent the risk of distal thrombosis caused by separating individual HNTs and offer the advantages of a simple preparation and application process. This study presents a novel first-aid hemostatic dressing and offers a novel approach to loading inorganic nanoparticles onto fibers.

Self-gelling, tunable adhesion, antibacterial and biocompatible quaternized cellulose/tannic acid/polyethylene glycol/montmorillonite composite powder for quick hemostasis

Hemostatic powders are widely used in incompressible or irregularly shaped bleeding wounds, but traditional hemostatic powders exhibit low adhesion, unsatisfactory hemostatic effect, limited infection control, and are not suitable for clinical or emergency situations. This study developed a novel self-gelling hemostatic powder (QTPM) consisting of quaternized cellulose (QC)/ tannic acid (TA)/ polyethylene glycol (PEG)/ montmorillonite (MMT). QTPM could absorb interfacial liquid hydrating to a stable hydrogel which form a switchable adhesion to tissues. Moreover, QTPM exhibits excellent antibacterial property by the synergistic effect of QC and TA. Furthermore, QTPM directly activate intrinsic and extrinsic coagulation hemostatic pathways to enhance hemostasis, and it concentrate coagulation factors. In vivo hemostasis study results show that QTPM significantly accelerated hemostasis and reduced blood loss compared with the blank group (>75 % reduction in hemostatic time, >85 % reduction in blood loss) in liver bleeding model (hemostasis time of 71.67 ± 7.09 s, blood loss of 19.23 ± 2.60 mg) and tail amputation model (hemostasis time of 91.03 ± 12.05 s, blood loss of 15.24 ± 1.77 mg). Therefore, the advantages of QTPM including rapid and effective hemostasis, easy usage, easy storability and adaptability make it a potential biomaterial for rapid hemostasis direction in the clinical setting.

Second-generation MOSES 2.0 versus MOSES 1.0 pulse-modulation technologies for holmium laser enucleation of the prostate (HoLEP).

To report our initial experience with enhanced MOSES 2.0 technology in patients who underwent holmium laser enucleation of the prostate (HoLEP) for the treatment of benign prostatic hyperplasia (BPH), in comparison to those who underwent HoLEP with MOSES 1.0 technology at our institution. We retrospectively reviewed data of patients who underwent HoLEP using MOSES 1.0 or MOSES 2.0 pulse-modulation technology from December 2020 to September 2023. Preoperative and intraoperative parameters, postoperative outcomes, as well as perioperative complications were collected and analyzed. A total of 196 patients were included in the study. Among them, 146 patients underwent MOSES 1.0 HoLEP, while 50 had MOSES 2.0 HoLEP. No statistically significant differences in preoperative characteristics were observed between the two groups. The median prostate volume for the MOSES 1.0 and MOSES 2.0 HoLEP groups was 109cc and 117.5cc, respectively. Patients in the MOSES 2.0 group had a shorter median enucleation time (52.5 vs. 42.5min, p < 0.001) and hemostasis time (8 vs. 6min, p = 0.002), along with lower laser energy usage (101 vs. 86.4kJ, p = 0.012), when compared to those in the MOSES 1.0 cohort. Postoperative outcomes, including IPSS, QoL, Qmax, and PVR, were comparable between the two groups at 1, 3, and 6 months postoperative. The incidence of hospital readmission (p = 0.42), as well as one-month postoperative urge urinary incontinence (p = 0.2) and stress urinary incontinence (p = 0.13) were also comparable between the cohorts. HoLEP with second-generation MOSES 2.0 technology is a safe and effective treatment option for BPH. It offers notable improvements, including reduced enucleation and hemostasis times, while using less energy when compared to MOSES 1.0.

Costs, efficiency, and patient-reported outcomes associated with suture-mediated percutaneous closure for atrial fibrillation ablation: Secondary analysis of a randomized clinical trial.

To evaluate the cost and efficiency of suture-mediated percutaneous closure (SMC) compared to manual compression (MC) after atrial fibrillation (AF) ablation. SMC has been demonstrated to be efficacious in reducing hemostasis and bedrest times after AF ablation. To date, randomized data comparing the direct and indirect cost between the two techniques have not been described. We conducted a 1:1 randomized trial comparing SMC to MC following AF ablation. The primary endpoints have been previously published. However, secondary endpoints pertinent to indirect cost including complication rates, hospital utilization (i.e., delays in discharge, additional patient encounters, nursing utilization), pain, patient reported outcomes, as well as the direct costs of care associated with AF ablation were collected. We also performed secondary analysis of the primary endpoint to evaluate for a learning curve, and subgroups analysis comparing efficacy across different numbers of access sites and compared to those in the MC group with a figure-of-eight suture (Fo8), that could potentially have impacted the relative efficiency of the procedure. A total of 107 patients were randomized and included: 53 in the SMC group and 54 in MC. A learning curve was observed in the SMC group between the first and second half of the study group (p = 0.037), with no such difference in the MC group. After accounting for the number of access sites, time to hemostasis remained shorter in the SMC Group (p = 0.002). Compared to those in the Fo8 arm (n = 37), the time to hemostasis remained shorter in the SMC group (p = 0.001). Among those planned for same-day discharge, there were more delays in the MC group (31.5% vs. 11.3%, p = 0.0144). Rates of major and minor complications were similar between SMC and MC groups at discharge (p = 0.243) and 30 days (p = 1.00), as were nursing utilization, self-reported pain, and overall patient reported outcomes. The overall cost of care related to the procedure was similar between the MC and SMC groups ($56 533.65 [$45 699.47, $66 987.64] vs. $57 050.44 [$47 251.40, $66 426.34], p = 0.601). SMC has been shown to decrease time to hemostasis and ambulation and facilitate earlier same-day discharge after AF ablation without an increase in direct or indirect costs.

Effect of lateral extent of pulp tissue removal on the outcome of partial pulpotomy for managing cariously exposed mature permanent molars with symptomatic irreversible pulpitis: A randomized clinical trial.

The aim of this study is to compare the outcomes of restricted partial pulpotomy (R-PP) versus extended partial pulpotomy (E-PP) for managing cariously exposed mature permanent molars with symptomatic irreversible pulpitis (SIP). This double-arm, parallel designed randomized clinical trial was registered at clinicaltrials.gov (registration number: NCT05406557). Following random allocation, 43 participants of each group received the designated intervention. In the R-PP group, 2-3 mm of superficial pulp tissue was removed only from the exposure site, while chamber was completely de-roofed and 2-3 mm of superficial pulp tissue from entire chamber was removed in the E-PP group. Haemostasis was achieved using 3% sodium hypochlorite-soaked cotton pellets. Upon haemostasis, ProRoot mineral trioxide aggregate (ProRoot MTA) was placed over the pulpal wound, overlaid with a resin-modified glass ionomer liner, and restored with composite resin in the same visit. Outcome measures included clinical and radiographic success evaluation at 6 and 12 months, and pain assessment using the visual analogue scale pre-operatively and daily for 7 post-operative days. Nonparametric tests were used for variables including patient's age, pain intensities, mean analgesic consumption, and haemostasis time. Categorical variables including gender, caries type, analgesic intake, hard tissue barrier formation, clinical and radiographic success, and pulp sensibility responses were assessed using Chi-square or Fisher's exact test. Tooth survival was analysed using Kaplan-Meier analysis. A total of 81 cases were analysed at 12 months follow-up. Comparable success was observed in both groups (97.6% in E-PP & 97.5% in R-PP; p > .05). The R-PP group reported significantly lower pain scores on the 1st and 2nd post-operative days than E-PP (p < .05) and required significantly less analgesic intake (p < .05). Hard tissue barrier formation was significantly lower in the R-PP group (p < .05). No significant differences were observed between groups regarding haemostasis time, pulp sensibility responses, and tooth survival (p > .05). Both the PP approaches exhibited comparable success for managing cariously exposed mature permanent molars with SIP. Given the conservative nature of R-PP, it may be used as preferred PP approach for managing such cases. Being the first study of this kind, further work is necessary to draw definitive conclusions.

Comparative Analysis of Electrosurgical Energy and Hemostatic Sealant for Hemostasis in Laparoscopic Ovarian Cystectomy: A Randomized Controlled Phase III Study

To evaluate the efficacy of hemostatic sealant versus elertrosurgical energy in achieving hemostasis and preserving postoperative ovarian reserve during laparoscopic ovarian cystectomy DESIGN: Randomized controlled trial SETTING: Single center study PATIENTS: A total of 121 patients undergoing laparoscopic ovarian cystectomy INTERVENTIONS: Patients were randomized to receive either hemostatic sealant or elertrosurgical energy for hemostasis during surgery MEASUREMENTS AND MAIN RESULTS: The primary outcome measured was the time required to achieve hemostasis. Secondary outcomes included operating time, estimated blood loss, and assessment of postoperative ovarian reserve through hormone levels (AMH, FSH, E2, Inhibin) at three follow-up intervals. The results showed comparable hemostasis times between the two groups. Postoperative hormone levels indicated no significant differences in the impact on ovarian reserve between the groups, except in cases of bilateral ovarian cystectomy (BOC), where the hemostatic sealant group exhibited a lesser decline in AMH levels. Both hemostatic sealant and electrosurgical energy showed equivalent effectiveness in achieving hemostasis during laparoscopic ovarian cystectomy, with comparable results in hemostasis time, blood loss, postoperative complications, and ovarian reserve preservation. However, in cases of bilateral ovarian cystectomy (BOC), the hemostatic sealant group exhibited a lesser decline in AMH levels, suggesting a potential advantage in preserving ovarian reserve in these specific cases.

A retrospective study on the outcome of pulpotomy with iRoot BP plus in primary molars and its relationship with hemostasis time

BackgroundPulpotomy is a crucial method to preserve primary teeth until natural exfoliation. This study aimed to evaluate the clinical and radiographic outcomes of pulpotomy with iRoot BP Plus in primary molars and to explore the association between hemostasis time and these outcomes.MethodsPrimary molars that underwent iRoot BP Plus pulpotomy and were followed for at least 12 months were selected for this study. Clinical and radiographic data were collected, and the success rate was analyzed in relation to factors such as hemostasis time, tooth type, and arch type. The tests of significance used were the chi-square test, Fisher’s exact test, or Kruskal-Wallis test. Statistical significance was set at P < 0.05.ResultsA total of 183 teeth in 106 patients were included in the analysis. The follow-up period fell into a range of 1–3 years, with a mean of 1.6 years. The clinical and radiographic success rates were 96.7% and 92.9%, respectively. The earliest time to observe the radiographic failures was half a year after the treatment, and the latest time was two years after the treatment. Among all the teeth, 130 were recorded with hemostasis time before the application of iRoot BP Plus. Compared to teeth with a hemostasis time of 5 min or less, teeth with a hemostasis time exceeding 5 min showed no significant differences in clinical and radiographic success (P = 1.000 and 0.879). Additionally, neither arch nor teeth type showed a relationship with the pulpotomy success rate (P > 0.05).ConclusionsPulpotomy using iRoot BP Plus in primary molars achieved favorable results. The hemostasis time may not significantly impact the outcomes of pulpotomy using iRoot BP Plus in primary molars.

Distal versus proximal radial access in coronary angiography: a meta-analysis.

Distal radial access (DRA) represents a promising alternative to conventional proximal radial access (PRA) for coronary angiography. Substantial advantages regarding safety and efficacy have been suggested for DRA, but the ideal access route remains controversial. The aim of this study was to compare safety, efficacy and feasibility of DRA to PRA. National Library of Medicine PubMed, Web of Science, clinicaltrials.gov and Cochrane Library were systematically searched for randomized controlled trials and registry studies comparing DRA and PRA that were published between January 1, 2017 and April, 2024. Primary endpoint was the rate of radial artery occlusion (RAO). Secondary endpoints were access failure, access time, procedure time, arterial spasm, hematoma, and hemostasis time. Data extraction was performed by two independent investigators. Relative risks were aggregated using a random effects model. We applied meta-analytic regression to assess study characteristic variables as possible moderators of the study effects. 44 studies with a total of 21,081 patients were included. We found a significantly lower rate of RAO after DRA (DRA 1.28%, PRA 4.76%, p < .001) with a 2.92 times lower risk compared to the proximal approach (Log Risk Ratio = -1.07, p < .001). Conversely, the risk for access failure was 2.42 times higher for DRA compared to PRA (Log Risk Ratio = 0.88, p < .001). In this largest meta-analysis to date, we were able to show that rates of RAO are reduced with DRA compared to conventional PRA. This suggests DRA is a safe alternative to PRA.

Efficacy and safety of the VASCADE® MVP venous vascular closure device in patients undergoing percutaneous left atrial appendage occlusion with WATCHMAN.

The VASCADE MVP venous vascular closure system is commonly used for percutaneous venotomy closure in catheter-based procedures utilizing sheath sizes 6-12 French. However, its application with larger sheaths such as ones required in left atrial appendage occlusion (LAAO) has yet to be explored. This study compared the efficacy and safety of VASCADE MVP versus conventional Figure-of-8 sutures (Fo8) for femoral venotomy closure in patients undergoing Watchman LAAO. This single-center retrospective analysis included patients who underwent post-LAAO femoral venotomy closure with either VASCADE MVP or Fo8 sutures. The primary efficacy endpoint was time to hemostasis (TTH). Primary safety endpoints were 30-day access site-related readmissions and major complications. Minor access-site-related complications were also assessed. 107 patients underwent post-LAAO femoral venotomy closure with VASCADE MVP, of which 101 were successful (94.4%). 99 patients underwent conventional closure with Fo8 sutures and supplemental manual pressure. Baseline characteristics were similar between groups. TTH was significantly shorter with VASCADE MVP (152.9 vs. 335.8 s, p = 0.001). Major safety outcomes were comparable. However, the conventional group experienced a higher incidence of ecchymosis (16.2% vs 4.7%, p = 0.007) and 30-day all-cause readmission (18.2% vs 8.4%, p = 0.038). VASCADE MVP significantly reduced TTH compared to Fo8 sutures after LAAO. While demonstrating a similar safety profile, VASCADE MVP may offer a more efficient approach to femoral vein closure in this patient population.

Synergistic Procoagulant Mechanism and Application of Kaolin-Zeolite Composite Hemostat for Effective Hemorrhage Control.

Achieving timely and effective hemorrhage control is imperative for the survival of individuals with severe bleeding. Hemostatic materials, by enhancing the natural cell-based coagulation response, are essential tools in modern and military medical practice for controlling bleeding, especially in emergency and surgical settings. Here, we report a new type of composite hemostatic material with two different aluminosilicate-based components, kaolin and zeolite, which synergistically work together in different stages of the coagulation cascade reactions. Kaolin can effectively activate the clotting factor FXII in the early stage, and zeolite can accumulate and assemble FXa and FVa on its surface and thereafter lead to the formation of highly active thrombin in the later stage. The synergistic action mechanism between kaolin and zeolite significantly boosts the levels of FXIIa and FXa, and it also greatly enhances plateau thrombin activity. For practical application, a kaolin-modified zeolite gauze is fabricated, and it demonstrates excellent hemostatic effectiveness. Compared to the combat gauze currently used in front-line treatment, it reduces blood loss by 75% and shortens hemostasis time by 33% in a rabbit femoral artery injury model. In addition, this kaolin-zeolite gauze has no heat release problem and a nearly zero particle shedding rate, which greatly decreases the safety risk compared to current commercial inorganic-based hemostatic gauzes.

Routine Protamine Administration for Bleeding in Transcatheter Aortic Valve Implantation

Vascular complications after transfemoral transcatheter aortic valve implantation (TAVI) remain an important cause of procedure-related morbidity. Routine reversal of anticoagulation with protamine at the conclusion of transfemoral TAVI could reduce complications, but data remain scarce. To evaluate the efficacy and safety of routine protamine administration after transfemoral TAVI. The ACE-PROTAVI trial was an investigator-initiated, double-blind, placebo-controlled randomized clinical trial performed at 3 Australian hospitals between December 2021 and June 2023 with a 1-year follow-up period. All patients accepted for transfemoral TAVI by a multidisciplinary heart team were eligible for enrollment. Eligible patients were randomized 1:1 between routine protamine administration and placebo. The coprimary outcomes were the rate of hemostasis success and time to hemostasis (TTH), presented as categorical variables and compared with a χ2 test or as continuous variables as mean (SD) or median (IQR), depending on distribution. The major secondary outcome was a composite of all-cause death, major and minor bleeding complications, and major and minor vascular complications after 30 days, reported in odds ratios (ORs) with 95% CIs and P values. The study population consisted of 410 patients: 199 patients in the protamine group and 211 in the placebo group. The median (IQR) patient age in the protamine group was 82 (77-85) years, and 68 of 199 patients receiving protamine (34.2%) were female. The median (IQR) patient age in the placebo group was 80 (75-85) years, and 89 of 211 patients receiving the placebo (42.2%) were female. Patients receiving up-front protamine administration had a higher rate of hemostasis success (188 of 192 patients [97.9%]) than patients in the placebo group (186 of 203 patients [91.6%]; absolute risk difference, 6.3%; 95% CI, 2.0%-10.6%; P = .006); in addition, patients receiving up-front protamine had a shorter median (IQR) TTH (181 [120-420] seconds vs 279 [122-600] seconds; P = .002). Routine protamine administration resulted in a reduced risk of the composite outcome in the protamine group (10 of 192 [5.2%]) vs the placebo group (26 of 203 [12.8%]; OR, 0.37; 95% CI, 0.1-0.8; P = .01). This difference was predominantly driven by the difference in the prevalence of minor vascular complications. There were no adverse events associated with protamine use. In the ACE-PROTAVI randomized clinical trial, routine administration of protamine increased the rate of hemostasis success and decreased TTH. The beneficial effect of protamine was reflected in a reduction in minor vascular complications, procedural time, and postprocedural hospital stay duration in patients receiving routine protamine compared with patients receiving placebo. anzctr.org.au Identifier: ACTRN12621001261808.

Novel Flowable Hemostatic Agent ActiClot: Efficacy and Safety Assessment in Rat and Porcine Models.

Background/Objectives: This study evaluated the hemostatic performance and safety of ActiClot (ATC), a new flowable hemostatic agent, through in vivo tests. Methods: ATC was compared with the commercially available FLOSEAL®. ATC consists of carboxymethyl starch, thrombin, and sorbitol powders in Syringe I, and a calcium chloride solution in Syringe II. In vivo evaluation used rat liver bleeding and porcine heart bleeding models. Safety was assessed using a rat subcutaneous implantation model. Results: ATC significantly reduced hemostasis time (70.00 ± 7.35 s) compared to gauze control (240.63 ± 32.31 s) in the rat liver model, showing a 70% reduction. There was no significant difference between ATC and FLOSEAL® (58.75 ± 13.42 s). In the porcine heart model, both agents achieved 100% hemostasis within 3 min, with no significant difference in success rates within 2 min (ATC 87.5%, FLOSEAL® 75%). The gauze control group failed in all tests. The rat subcutaneous implantation model showed no visual ATC observation after 48 h, indicating biocompatibility, with no inflammation observed. Conclusions: ATC demonstrated effective hemostatic performance similar to FLOSEAL® in two in vivo models, with faster hemostasis in the rat liver model. It also showed excellent safety and biocompatibility, indicating its potential for surgical and emergency bleeding control.

A thermal cross-linking approach to developing a reinforced elastic chitosan cryogel for hemostatic management of heavy bleeding

Uncontrolled hemorrhage stands as the primary cause of potentially preventable deaths following traumatic injuries in both civilian and military populations. Addressing this critical medical need requires the development of a hemostatic material with rapid hemostatic performance and biosafety. This work describes the engineering of a chitosan-based cryogel construct using thermo-assisted cross-linking with α-ketoglutaric acid after freeze-drying. The resulting cryogel exhibited a highly interconnected macro-porous structure with low thermal conductivity, exceptional mechanical properties, and great fluid absorption capacity. Notably, assessments using rabbit whole blood in vitro, as well as rat liver volume defect and femoral artery injury models simulating severe bleeding, showed the remarkable hemostatic performance of the chitosan cryogel. Among the cryogel variants with different chitosan molecular weights, the 150 kDa one demonstrated superior hemostatic efficacy, reducing blood loss and hemostasis time by approximately 73 % and 63 % in the hepatic model, and by around 60 % and 68 %, in the femoral artery model. Additionally, comprehensive in vitro and in vivo evaluations underscored the good biocompatibility of the chitosan cryogel. Taken together, these results strongly indicate that the designed chitosan cryogel configuration holds significant potential as a safe and rapid hemostatic material for managing severe hemorrhage.

Feasibility, safety, and efficacy of a novel external compression vascular closure device: The LockeT® study.

Hemostasis following large-bore femoral vein access remains a challenge. Manual compression has been the standard of care but requires bedside staff, prolonged bed rest, and longer length of stay. The LockeT is an external compression device that attempts to address these issues while achieving venous hemostasis. We evaluate postprocedural hemostasis and vascular closure outcomes after using LockeT following cardiac electrophysiologic procedures. We performed a single-center, observational study of patients who underwent vascular closure for electrophysiology procedures using LockeT. Postprocedural outcomes were subsequently analyzed. We studied 102 patients (N) for whom LockeT was used to close 182 separate vascular access sites (n). Common procedures were atrial fibrillation ablation (56.9%, N = 58) and left atrial appendage occlusion (28.4%, N = 29). Most often, 8-Fr [48.3% (n = 126)], 11-Fr [27.2% (n = 71)], and 8.5-Fr [16.9% (n = 44)] sheaths were used, with an average procedure time of 82.1 ± 29.4 min. Hemostasis was achieved in 97.8% (n = 187) of all LockeT cases. Time to ambulation and discharge were 3.93 ± 1.10 hand 8.1 ± 4.4 h, respectively. No major complications were noted. Postprocedurally, 52% (N = 53) of patients were discharged on the same day. There were no differences in hemostasis (p = .859) or ambulation times (p = .202) between procedure types. The LockeT can effectively close venous access sites with no major complications.

Ultrasound-Assisted Sagittal View for Retrograde Puncture of the P2 Segment of Popliteal Artery for Recanalization of Femoropopliteal Lesions

To assess the safety and efficacy of ultrasound-assisted sagittal view for retrograde puncture of the P2 segment of popliteal artery (PA) for treating femoropopliteal lesions. A retrospective study was conducted on consecutive patients who underwent retrograde puncture of the PA for the recanalization of femoropopliteal lesions. A retrograde access was made to either the P2 or P3 segment of the PA in 23 cases. In 10 cases (8 men; mean age 68±9years), ultrasound-guided retrograde PA (P2 segment) puncture using the long-axis in-the-plane approach was performed, and in 13 cases (11 men; mean age 69±5years), angiography-guided retrograde PA (P3 segment) puncture was performed. Clinical data was compared preintraoperatively and postoperatively in the 2 groups. All occluded lesions were successfully recanalized via dual channel intervention. Puncture success were 100% (10/10) in the P2 group compared with 92.3% (12/13) in the P3 group (P>0.05). The mean puncture time in the P2 group was significantly shorter when compared to the P3 group (4.70±0.95mins vs 11.33±6.37mins; P<0.05). There was no difference in mean hemostasis time between the 2 groups (6.11±2.20mins vs 8.46±3.76mins; P>0.05). There were no in-hospital deaths in all patients. The occurrence of puncture-related complications in the P2 group was 10% compared with 15% in the P3 group (P>0.05). A low-flow arteriovenous fistula was observed in one case in the P3 group. None of the patients reported any access-related complication at a mean follow-up of 11.3±5.5months. Ultrasound-assisted sagittal view for retrograde puncture of the P2 segment of PA is at least as safe as angiography-guided retrograde puncture of the P3 segment for femoropopliteal lesions. Furthermore, this technique appears to be more suitable for patients with tandem iliofemoral artery occlusion, as it allows for the creation of a retrograde access.