Outcomes of vascular closure devices for femoral venous hemostasis following catheter ablation of atrial fibrillation.

INTRODUCTION: Access site complications remain common following atrial fibrillation (AF) catheter ablation. Femoral vascular closure devices (VCDs) reduce time to hemostasis compared with manual compression, although large-scale data comparing clinical outcomes between the two approaches are lacking. METHODS: Two cohorts of patients undergoing AF ablation were identified from 36 healthcare organizations using a global federated research network (TriNetX): those receiving a VCD for femoral hemostasis, and those not receiving a VCD. A 1:1 propensity score matching (PSM) model based on baseline characteristics was used to create two comparable cohorts. The primary outcome was a composite of all-cause mortality, vascular complications, bleeding events, and need for blood transfusion. Outcomes were assessed during early (within 7 days of ablation) and extended follow-up (within 8-30 days of ablation). RESULTS: After PSM, 28 872 patients were included (14 436 in each cohort). The primary composite outcome occurred less frequently in the VCD cohort during early (1.97% vs. 2.60%, odds ratio (OR) 0.76, 95% confidence interval (CI) 0.65-0.88; p < .001) and extended follow-up (1.15% vs. 1.43%, OR 0.80, 95% CI 0.65-0.98; p = .032). This was driven by a lower rate of vascular complications during early follow-up in the VCD cohort (0.83% vs. 1.26%, OR 0.66, 95% CI 0.52-0.83; p < .001), and fewer bleeding events during early (0.90% vs. 1.23%, OR 0.73, 95% CI 0.58-0.92; p = .007) and extended follow-up (0.36% vs. 0.59%, OR 0.61, 95% CI 0.43-0.86; p = .005). CONCLUSION: Following AF ablation, femoral venous hemostasis with a VCD was associated with reduced complications compared with hemostasis without a VCD.

Evaluation of the safety and efficacy of the Axiostat® dressing device to achieve radial artery access hemostasis: The R3A study.

BACKGROUND: Radial access is the default approach in interventional cardiology. The Axiostat® surgical hemostatic dressing, using chitosan as its active component, has demonstrated potential in accelerating blood clotting. This study aims to assess the efficacy and the safety of the Axiostat® dressing in achieving hemostasis in patients undergoing transradial coronary angioplasty (TRCA). METHODS: This prospective, single-center observational study, conducted in 2022, enrolled consecutive patients undergoing TRCA, with a target of 150 participants. The primary outcome was the success rate of radial artery hemostasis at 120 min, without bleeding necessitating immediate re-compression. The secondary outcome included Axiostat® performance at 24 h and 30 days Postprocedure. RESULTS: The study was terminated prematurely for ethical and patient safety reasons, after inclusion of 41 consecutive TRCA patients due to an unexpectedly high radial artery thrombosis rate (19.5%, n = 8/41) observed 24 h Postprocedure. The success rate of radial hemostasis with the Axiostat® dressing was 78.0%. Procedural details and patient characteristics were comparable between successful Axiostat® removal and device failure cases. CONCLUSION: The use of the Axiostat® dressing to achieve hemostasis after TRCA is effective but is associated with an unexpectedly high incidence of radial thrombosis. Our results should encourage caution in the future evaluation and use of this device for radial artery compression following TRCA.

Single suture-mediated closure system after transfemoral transcatheter aortic valve implantation: A single-center real-world experience.

BACKGROUND: Despite the use of two crossed Perclose ProGlide™ (Abbott Vascular Devices) is the most widespread technique to close the main arterial access in transfemoral transcatheter aortic valve implantation (TF-TAVI), the safest and most effective strategy still remains much debated. AIMS: The aim of the present study was to evaluate the performance of a single Perclose ProGlide suture-mediated closure device to obtain femoral hemostasis after sheathless implantation of self-expanding transcatheter heart valves through their 14 F-equivalent fix delivery systems. METHODS: This prospective observational study included 439 patients undergoing TF-TAVI at the "Montevergine" Clinic of Mercogliano, Italy. All patients underwent hemostasis of the large-bore access using a single Perclose ProGlide with preclose technique, after sheathless implantation of self-expanding transcatheter heart valves through 14 F-equivalent fix delivery systems. A multidetector computed tomography analysis of size, tortuosity, atherosclerotic, and calcification burdens of the ilio-femoral access route was made by a dedicated corelab. Vascular complications (VCs), percutaneous closure device (PCD) failure, and bleedings were adjudicated by a clinical events committee. RESULTS: A total of 81 different VCs were observed in 60 patients (13.7%); among these, 41 (5% of patients) were categorized as major. PCD failure occurred in 14 patients (3.2%). At the logistic regression analysis, no predictors of PCD failure have been identified. CONCLUSION: This registry suggests that the use of a single suture-mediated closure device could be considered a safe and efficient technique to achieve access site hemostasis in patients undergoing TF-TAVI through 14 F-equivalent fix delivery systems.

Venous vascular closure system vs. figure-of-eight suture following atrial fibrillation ablation: the STYLE-AF Study.

AIMS: Simplified ablation technologies for pulmonary vein isolation (PVI) are increasingly performed worldwide. One of the most common complications following PVI are vascular access-related complications. Lately, venous closure systems (VCSs) were introduced into clinical practice, aiming to reduce the time of bed rest, to increase the patients' comfort, and to reduce vascular access-related complications. The aim of the present study is to compare the safety and efficacy of using a VCS to achieve haemostasis following single-shot PVI to the actual standard of care [figure-of-eight suture and manual compression (MC)]. METHODS AND RESULTS: This is a prospective, multicentre, randomized, controlled, open-label trial performed at three German centres. Patients were randomized 1:1 to undergo haemostasis either by means of VCS (VCS group) or of a figure-of-eight suture and MC (F8 group). The primary efficacy endpoint was the time to ambulation, while the primary safety endpoint was the incidence of major periprocedural adverse events until hospital discharge. A total of 125 patients were randomized. The baseline characteristics were similar between the groups. The VCS group showed a shorter time to ambulation [109.0 (82.0, 160.0) vs. 269.0 (243.8, 340.5) min; P < 0.001], shorter time to haemostasis [1 (1, 2) vs. 5 (2, 10) min; P < 0.001], and shorter time to discharge eligibility [270 (270, 270) vs. 340 (300, 458) min; P < 0.001]. No major vascular access-related complication was reported in either group. A trend towards a lower incidence of minor vascular access-related complications on the day of procedure was observed in the VCS group [7 (11.1%) vs. 15 (24.2%); P = 0.063] as compared to the control group. CONCLUSION: Following AF ablation, the use of a VCS results in a significantly shorter time to ambulation, time to haemostasis, and time to discharge eligibility. No major vascular access-related complications were identified. The use of MC and a figure-of-eight suture showed a trend towards a higher incidence of minor vascular access-related complications.

A latent bleeding complication in ipsilateral common femoral puncture involving delayed diagnosis: a case report.

BACKGROUND: The trans femoral ipsilateral approach is often adopted for endovascular treatment (EVT) for better steerability of guidewires or better device deliverability. However, contrary to the trans femoral contralateral approach, ipsilateral antegrade puncture sometimes causes peculiar bleeding complications. CASE PRESENTATION: A 76-year-old female underwent EVT for chronic occlusion of the left superficial femoral artery (SFA) via the ipsilateral antegrade approach. After guidewire passage, we inflated the drug-coated balloons, but angiography showed blood flow stasis at the mid segment of the SFA. We also ensured prolonged balloon inflation, which resulted in favorable blood flow. While trying to ensure hemostasis, the blood pressure remained decreased, but neither bleeding nor superficial hematoma were observed at the puncture site. After hemostasis was achieved, we removed the surgical drape and noticed a swelling in the mid-portion of the thigh, distant from the puncture point. We then approached the left common femoral artery (CFA) contralaterally. Angiography showed continuous bleeding from a little bit distally to the sheath insertion point that was spreading through an intramuscular space. We stopped the bleeding with balloon tamponade inside the CFA. Angiography after hemostasis demonstrated blood flow stasis at the mid-segment of the SFA, similarly as that seen before. We confirmed compression of the SFA by a large hematoma using both intra- and extra- vascular ultrasound. Therefore, we deployed a self-expandable stent at the compressed SFA position. Finally, we achieved favorable blood flow on angiography. CONCLUSION: We encountered a case that latent bleeding unrecognized in the surgical field persisted while prolonged inflation of DCB was conducted at just proximal SFA. We could have avoided bailout stenting by noticing the bleeding incident in a timely manner. Prediction and prevention are essential for all kinds of procedural complications in EVT.

Enhancing Arterial Closure in Endovascular Aortic Procedures: The Efficacy of Echo-Guided ProGlide Technique.

BACKGROUND: Endovascular aortic surgery is increasingly becoming the standard treatment. Percutaneous access preclosing systems appear to be effective and notably the Proglide (PG). We aimed to prospectively assess the clinical effectiveness of combining ultrasound-guided femoral puncture with ultrasound-guided PG deployment. METHODS: Our single-center study consecutively included patients managed at a tertiary center from May to September 2023, undergoing endovascular aortic surgery. The placement of PG was performed under ultrasound guidance. Preoperative patient characteristics were evaluated using preoperative computed tomography scans. Clinical and technical success were defined, respectively, as the ability to achieve complete hemostasis confirmed by ultrasound 48 hr postprocedure and as the successful placement of a PG under ultrasound guidance contributing to final hemostasis. RESULTS: Twenty patients were included over a 6-month period, totaling 34 common femoral arteries (CFAs). Fourteen were male, with an average age of 72.8 ± 8.2 years. Among the 34 CFA, CFA had diameter of 12.05 ± 2.4 mm and a depth of 38.0 ± 13.4 mm. The mean introducer sheath diameter was 6.2 ± 1.5 mm with a sheath to femoral artery ratio of 0.54 ± 0.18. Successful Proglide placement under ultrasound guidance was achieved in 100% of cases. No PG failure occurred. Clinical and technical success were, respectively, of 95% and 100%. One small pseudoaneurysm was observed at 48 hr treated medically. No CFA access reintervention was required. CONCLUSIONS: The technique of ultrasound-guided PG deployment in aortic surgery is a safe and effective method for achieving hemostasis. It effectively prevents PG failures at a lower cost.

Rapid haemostasis to achieve dressing longevity: evaluation trial results using StatSeal catheter exit site protection.

Peripherally inserted central catheters (PICCs) are vital in delivering intravenous therapy. Despite their advantages, PICCs can lead to complications such as catheter exit site bleeding, which can cause patient distress and increase infection risk. This study evaluated the efficacy of StatSeal, a topical haemostatic device, in managing PICC exit site bleeding. StatSeal uses a hydrophilic polymer and potassium ferrate to form a seal, reducing access site bleeding and minimising dressing changes. For this study, Patients were recruited at Frimley Health NHS Foundation Trust; the trial involved 177 patients with StatSeal, and shows that 99% did not require additional dressing changes within the standard 7-day period. The findings demonstrate StatSeal's effectiveness in improving patient outcomes by reducing exit site bleeding and associated complications, enhancing the efficiency of vascular access maintenance and potentially lowering associated healthcare costs. The trial emphasises the importance of innovative solutions such as StatSeal to advance PICC care and improve patient experience.

Sheath Size Up and Down With Single Proglide - A Technique for Achieving Hemostasis With Use of Large Size Delivery System During Endovascular Graft Placement.

BACKGROUND: A total percutaneous approach for management of aortic pathologies with endovascular grafts requires the use of large size delivery-systems. The diameter of these delivery systems usually exceeds the recommended sizes for most of the currently available percutaneous closure devices. A safe, effective and simple vascular access site closure device is desirable for success for percutaneous procedures for aortic pathologies. Hence, we aim to study safety and effectiveness of the use of a single suture based vascular access closure device (ProGlide) using a technique involving serial up and downsizing of the sheath size to achieve access site hemostasis in patients undergoing endovascular graft placement using femoral artery approach. MATERIALS AND METHODS: We studied all consecutive patients who underwent endovascular grafting from January 2018 to December 2019. It is a retrospective observational study comparing procedural and short-term outcomes between single ProGlide use and surgical cut-down for femoral access site closure. We excluded patients with femoral artery minimal luminal diameter less than 5 mm, the presence of an aneurysm of the femoral artery, ≥180 degrees of calcium present at femoral/ external iliac artery and history of any vascular closure device use in the last six months. RESULTS: We included 30 patients in single ProGlide group and 30 patients in the surgical cut-down group. One-third of the procedures were urgent procedures in the single Proglide group. Single ProGlide was successful in 93.34% patients and failure (6.66%) was seen due to hematoma and pseudoaneurysm in one patient each detected before discharge. The primary end-point defined by the success of procedure did not differ between the two groups. There were higher complications in the surgical group till 30 days as evidenced by infection, hematoma and neuronal injury. The secondary end-point, defined by the composite of complication events after discharge till 30 days was significantly higher in the surgical group (P-0.005) CONCLUSION: In patients with suitable femoral artery anatomy who undergo endovascular graft placement, effective hemostasis can be achieved safely using up and downsizing of the sheath with a single suture-based technique (Proglide). The results of the study could be considered hypothesis generating and needs to be confirmed in a randomized controlled trial before being adopted in clinical practice.

Expedient Endovascular Hemorrhage Control During Anterior Lumbar Spinal Exposure Allows Procedural Completion in Rescued Patients.

OBJECTIVES: To propose a contemporary management strategy for venous injury during anterior lumbar spinal exposure that incorporates endovascular treatment. METHODS: Vein injuries suffered by patients treated in a single practice were reviewed. A treatment algorithm based on these experiences was formulated. RESULTS: Between 2015 and 2018, 914 patients received anterior access procedures for indicated lumbar interbody fusions. Of these patients, 15 (1.6%) suffered minor vascular injuries treated with manual pressure or suture repair. Four (0.4%) patients undergoing anterior lumbar spine surgery suffered major venous injuries, all of whom received the indicated spinal hardware following endovascular rescue. Primary repair was attempted in three patients before endovascular control and not at all in one. Vascular access was obtained via the bilateral femoral veins in 2 patients, unilateral femoral in one, and bilateral femoral plus right internal jugular vein in one. Stent choice included both uncovered (5, 63%) and covered stents (3, 38%). Deep venous thrombosis occurred in 2 patient's post-treatment. 1 DVT was encountered in the setting of a covered stent and 1 uncovered stent thrombosis was treated with catheter-directed lysis 4 weeks post-operatively. Ultimately, 3 patients were therapeutically anticoagulated. Mean follow-up is 13 months (range 1-36) with duplex ultrasounds available at 6 months or later in 3 of 4 patients. There is no evidence of post-thrombotic syndrome in the 2 patients that developed DVT's or in-stent stenosis in the 3 patients with available follow-up imaging. CONCLUSIONS: Endovascular techniques are important adjuncts when controlling large-volume hemorrhage associated with venous tears during anterior spinal exposure. Adequate direct compression allowing occlusion balloon inflation are key steps to reduce blood loss. Covered and uncovered stents are both appropriate choices to treat injuries. Patients must be anticoagulated post-operatively and surveilled for the sequelae of venous insufficiency. With expedient hemostasis, the indicated spinal surgery may be safely completed.

Outcomes of routine use of percutaneous access with large-bore introducer sheaths (>21F outer diameter) during endovascular aneurysm repair.

OBJECTIVE: The objective of this study was to evaluate the performance of percutaneous femoral access with large-bore sheaths (>21F outer diameter) mainly employed for thoracic and thoracoabdominal aortic endovascular treatment and to stratify the outcomes on the basis of the introducer size. METHODS: Between December 2015 and December 2018, all consecutive patients who received endovascular repair through a percutaneous approach with a suture-mediated vascular closure device (VCD) and the preclose technique were included in a retrospective single-center study called Totally Percutaneous Approach to Endovascular Treatment of Aortic Aneurysms (PEVAR-PRO). The morphologic characteristics of the access vessels and patients' demographics were recorded, and 30-day closure success was defined as the primary end point. Analysis of the closure success comparing large-bore sheaths vs small-bore sheaths (≤21F outer diameter) was performed after 1:1 propensity score matching of preoperative confounding variables. RESULTS: The closure success rate of the entire study cohort was 94% (622 femoral accesses in 360 patients; median age, 74 years; 84% male). Univariate analysis identified eight different factors associated with failure, but only two remained significant on multivariate analysis: diabetes (odds ratio [OR], 2.8; 95% confidence interval [CI], 1.3-6.2; P = .011) and common femoral artery stenosis >50% (OR, 4.5; 95% CI, 1.3-13.7; P = .019). After propensity score matching (1:1, 172 femoral accesses per group), closure success rate was not significantly different between large-bore and small-bore sheaths (90.7% vs 93.0%; P = .43). Multivariate analysis of the large-sheath group identified two factors associated with failure: small (<9 mm) femoral arteries (OR, 6.9; 95% CI, 1.5-31.6; P = .13) and access vessel calcifications involving more than one-third of the circumference (OR, 7.9; 95% CI, 2.1-29.4; P = .002). Neither previous femoral cutdown (44 accesses [23%]) nor percutaneous closure with VCDs (38 accesses [20%]) affected the closure success rate in the large-sheath group. Closure failure did not significantly increase the need for postoperative blood transfusions or hospital length of stay. CONCLUSIONS: Off-label use of VCDs and the preclose technique for percutaneous approach with large-bore sheaths needed for complex aortic endovascular procedures is safe and feasible. Closure success rate is not significantly different from that obtained with on-label application of VCDs with smaller sheaths.

Complication rates associated with antegrade use of vascular closure devices: a systematic review and pooled analysis.

BACKGROUND: Vascular closure devices (VCDs) have become a mainstay in endovascular interventions in recent years. On-label use only allows for retrograde interventions originating at the common femoral artery (CFA). However, off-label use in antegrade and/or superficial femoral artery (SFA) access has become more common in the treatment of peripheral arterial disease. Despite this, there is a paucity of comparative literature assessing individual VCD safety profiles and relative complication risks of CFA vs SFA applications. METHODS: MEDLINE and EMBASE systematic searches were performed from inception to October 2019 to identify studies assessing VCD use in antegrade CFA and SFA interventions. Abstract selection and data extraction were performed by two independent reviewers. Primary outcomes included bleeding-related complications, vessel occlusion or stenosis, embolization, pseudoaneurysm formation, or arteriovenous fistula formation. RESULTS: Twenty-four unique studies with 4124 vascular closure events via six unique VCDs were included (Angioseal, Exoseal, Femoseal, Glubran 2, Mynx, Starclose; 3698 CFA, 426 SFA). Pooled occurrence of all complications across closure devices used in the CFA and SFA ranged from 0.9% (Mynx) to 7.4% (Starclose) and 0% (Perclose) to 10.1% (Starclose), respectively, depending on VCD type. Clinically meaningful differences were identified between devices with a trend toward significance (P = .08 CFA, P = .07 SFA). Individual devices demonstrated a range of bleeding complication rates from 0.4% (Mynx) to 7.2% (Femoseal) for the CFA site and from 0% (Perclose) to 6.4% (Starclose) for the SFA site (P = .01 and P = .03, respectively). Significant heterogeneity between studies precludes definitive characterization of the device as cause for variations in bleeding complication rates. Pooled complication rates did not differ between the CFA and SFA arms (4.6% vs 5.8%, P = .56). Bleeding complication rates also did not differ between the CFA and SFA arms (3.6% vs 3.6%, P = .98). CONCLUSIONS: Clinically meaningful differences in overall pooled complications were identified between VCDs with a trend toward significance. Significant differences between VCDs exist with respect to bleeding risk. However, this must be interpreted with caution as these differences could be secondary to interstudy heterogeneity. Finally, no difference was identified between antegrade SFA and CFA VCD use with respect to overall complication and bleeding risks.

Initial single centre experience of Aquablation of the prostate using the AquaBeam system with athermal haemostasis for the treatment of benign prostatic hyperplasia: 1-year outcomes.

PURPOSE: Aquablation using the AquaBeam system combines real-time image guidance and robotics to enable precise and heat-free removal of prostatic tissue with a high velocity water jet. The aim of this study is to report the outcomes of Aquablation up to 1 year in a single centre within the UK employing an athermal approach to haemostasis. METHODS: Fifty-five consecutive men underwent Aquablation between September 2017 and December 2018 (as part of OPEN WATER trial). Standard Aquablation was performed with the AquaBeam system (PROCEPT® BioRobotics) with 2 passes of Aquablation followed by bladder washout with application of continuous bladder irrigation via a catheter on a continuous traction device. Patients were followed up at 3 and 12 months. The data were prospectively collected on patient demographics, uroflowmetry, prostate volume, International Prostate Symptom Score (IPSS), Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD) and International Index of Erectile Function (IIEF-15). RESULTS: The mean age was 64.1 ± 7.9 years. Operating time was 26.9 ± 9.2 min. Mean prostate volume decreased from 58.2 ± 23.9 cc to 33.2 ± 12.9 cc (p < 0.0001). There were significant improvements at the 12 month follow-up in maximum urinary flow rate (9.9 ± 5.1 ml/s vs. 23.9 ± 11.6 ml/s), IPSS (21.7 ± 7.4 vs. 6.1 ± 4.2) and quality of life score (4.8 ± 1.1 vs. 1.4 ± 1.4) (p < 0.0001). There was no significant change in IIEF-15 and MSHQ-EjD scores. There were 8 (14.5%) Clavien grade 2 or higher complications. CONCLUSION: Our single centre experience suggests Aquablation using an entirely athermal approach is a safe cavitating procedure resulting in significant LUTS improvement comparable to standard cavitating procedures with greater preservation of sexual function.

The quantra hemostasis analyzer compared to thromboelastography (TEG) in the surgical oncologic population: A prospective observational trial.

BACKGROUND: Management of coagulopathy during major oncologic surgery can be multifactorial and challenging. Viscoelastic assays (VEAs) can be useful in providing vital data about the mechanism of coagulopathy in these dynamic circumstances. OBJECTIVES: A prospective nonrandomized observational study with the aim of describing the coagulation parameters of patients undergoing major oncologic surgery using the Quantra® and TEG® 5000 systems. Our secondary objectives included the correlation between Quantra and TEG parameters, and the times to result for both technologies. METHODS: This study included 74 adults undergoing oncologic surgery with an anticipated blood loss of more than 500 ml. For each subject, whole blood samples for each device were collected at multiple points perioperatively for comparison. RESULTS: Correlation coefficients between Quantra and TEG parameters were 0.8 and above, indicating a very strong correlation (p < .001). Correlation coefficients between conventional laboratory tests and Quantra ranged from 0.74 to 0.83, indicating a moderate correlation (p < .001). The mean time to obtain results and total processing time was shorter for Quantra in comparison to TEG. CONCLUSIONS: Quantra parameters strongly correlated with TEG parameters; however, Quantra parameters were available in shorter amount of time as it is specifically designed as a closed point of care device.

Ultrasound-Guided Deployment of a Plug-Based Vascular Closure Device in Femoral Arteries with Calcified Plaque or Stenosis.

From January 2019 to January 2020, 106 patients (age, 64.8 ± 14.1 years; male, 63.2%) were included to retrospectively investigate the feasibility and safety of ultrasound-guided deployment of ExoSeal after femoral artery access. Baseline characteristics were not different except for age (P = .022), body mass index (P = .009), and diameter (P < .001) between the calcified plaque or stenosis (CS) group (n = 49) and non-CS group (n = 57). The overall technical and clinical success rates were 96.2% and 100%, respectively. The technical (CS group, 48/49; non-CS group, 54/57) and clinical success rates (100%), time to hemostasis (CS group, 3.21 ± 0.54 min; non-CS group, 3.39 ± 0.71 min), and complication rates (CS group, 1/49; non-CS group, 0/57) were not different between the 2 groups. ExoSeal seems to be safe to use under ultrasound guidance in the femoral arteries with CS.

Effectiveness of uterine tamponade devices for refractory postpartum haemorrhage after vaginal birth: a systematic review.

OBJECTIVES: To evaluate uterine tamponade devices' effectiveness for atonic refractory postpartum haemorrhage (PPH) after vaginal birth and the effect of including them in institutional protocols. SEARCH STRATEGY: PubMed, EMBASE, CINAHL, LILACS, POPLINE, from inception to January 2021. STUDY SELECTION: Randomised and non-randomised comparative studies. OUTCOMES: Composite outcome including surgical interventions (artery ligations, compressive sutures or hysterectomy) or maternal death, and hysterectomy. RESULTS: All included studies were at high risk of bias. The certainty of the evidence was rated as very low to low. One randomised study measured the effect of the condom-catheter balloon compared with standard care and found unclear results for the composite outcome (relative risk [RR] 2.33, 95% CI 0.76-7.14) and hysterectomy (RR 4.14, 95% CI 0.48-35.93). Three comparative studies assessed the effect of including uterine balloon tamponade in institutional protocols. A stepped wedge cluster randomised controlled trial suggested an increase in the composite outcome (RR 4.08, 95% CI 1.07-15.58) and unclear results for hysterectomy (RR 4.38, 95% CI 0.47-41.09) with the use of the condom-catheter or surgical glove balloon. One non-randomised study showed unclear effects on the composite outcome (RR 0.33, 95% CI 0.11-1.03) and hysterectomy (RR 0.49, 95% CI 0.04-5.38) after the inclusion of the Bakri balloon. The second non-randomised study found unclear effects on the composite outcome (RR 0.95, 95% CI 0.32-2.81) and hysterectomy (RR 1.84, 95% CI 0.44-7.69) after the inclusion of Ebb or Bakri balloon. CONCLUSIONS: The effect of uterine tamponade devices for the management of atonic refractory PPH after vaginal delivery is unclear, as is the role of the type of device and the setting. TWEETABLE ABSTRACT: Unclear effects of uterine tamponade devices and their inclusion in institutional protocols for atonic refractory PPH after vaginal delivery.

Closure device use for common femoral artery antegrade access is higher risk than retrograde access.

OBJECTIVE: Although the use of closure devices (CD) for femoral artery antegrade access (AA) is not in the instructions for use (IFU) for many devices, AA has been reported to be associated with a lower incidence of access site complications compared to manual compression alone. We hypothesized that CD use for AA would not be associated with a clinically significant increased odds of access site complications compared to CD use for retrograde access (RA). METHODS: This was a retrospective review of the Vascular Quality Initiative from 2010 to 2019 for infrainguinal peripheral vascular interventions with common femoral artery access closed with a CD. Patients who had a cutdown or multiple access sites were excluded. Cases were then stratified into whether access was antegrade or retrograde. Hierarchical multivariable logistic regressions controlling for hospital level variation were used to examine the independent association between AA and access site complications. The primary outcomes were access site hematoma, stenosis, or occlusion as defined in the VQI. The secondary outcome was the development of an access site hematoma requiring an intervention, which was defined as transfusion, thrombin injection, or surgery. Sensitivity analyses after coarsened exact matching were performed to reduce residual bias. RESULTS: Overall, 72,463 cases were identified and 6,070 (8.4%) had AA. Patients with AA were less likely to be smokers (27.2% vs 33.0%) or obese (31.5% vs 35.6%; all P<0.05). Patients with AA were more likely to be on dialysis (12.8% vs 10.1%) and have ultrasound-guided access (76.4% vs 66.2%; P<0.05 for all). Compared to RA, patients with AA were more likely to develop any access site hematoma (2.5% vs 1.8%; P<0.01) and a hematoma requiring intervention (0.7% vs 0.5%; P=0.03), but had no difference in access site stenosis or occlusion (0.3% vs 0.2%; P=0.21). On multivariable analyses, AA had increased odds of developing any access site hematoma (OR=1.46; 95% CI=1.22-1.76) and a hematoma requiring intervention (OR=1.48; 95% CI=1.10-1.98). Sensitivity analyses after coarsened exact matching confirmed these findings. CONCLUSION: In this nationally representative sample, the use of CDs for femoral access was associated with an overall low rate of access site complications. However, there was an increased odds of access site hematomas with AA. Patient selection for AA remains important and ultrasound guided access should be the standard of care for this approach.

Pledget Reinforcement and Tractional Compression as Adjunctive Techniques for Suture-Mediated Closure (SMC) in Percutaneous Endovascular Aneurysm Repair (pEVAR): A Retrospective Observational Cohort Study.

BACKGROUND: Percutaneous endovascular aneurysm repair (pEVAR) is commonly utilized and requires the use of suture-mediated closure (SMC) devices to ensure adequate femoral artery hemostasis. Despite the use of such devices, puncture-related complications remain relatively common. We introduced two new adjuncts (pledget reinforcement and tractional compression) along with SMC to reduce such puncture-related complications. The aim of the study was to assess the efficacy and safety of the new adjunct techniques. METHODS: This retrospective observational cohort study examines the impact of two adjunctive techniques on puncture-related complications compared with the previous year data before this new introduction of adjunct techniques. RESULTS: Sixty-one percutaneous femoral punctures (in 31 patients) utilizing adjunct techniques for closure (the adjunct group) were retrospectively compared with 89 punctures (in 46 patients) closed with standard SMC technique (the standard group). The use of adjunctive techniques led to a significant reduction in overall puncture-related complications (3/61 (4.9%) vs. 20/89 (22.5%), P = 0.0106) and the need for emergent surgical repair after failed hemostasis (2/61 (3.3%) vs. 13/89 (14.6%), P = 0.037). CONCLUSIONS: These novel adjunctive techniques (pledget reinforcement and tractional compression) of SMC for pEVAR reduce puncture-related complications and increase the confidence to offer percutaneous techniques for more patients.

The Use of a Suture Mediated Vascular Closure Device to Achieve Hemostasis following Arterial Access through Previously Implanted Synthetic Grafts.

BACKGROUND: Percutaneous endovascular aneurysm repair (EVAR) and peripheral interventions using the Perclose Proglide suture mediated system has not been adequately studied in patients with synthetic grafts at access sites. METHODS: We report the use of the Perclose Proglide in 10 patients in whom previously inserted synthetic grafts in the groin were punctured for arterial access (5 for peripheral interventions and 5 undergoing EVAR). In patients undergoing peripheral interventions a single device was used, while in patients undergoing EVAR 2 devices were employed per access site. The preclosing technique was used in every case. RESULTS: Hemostasis was achieved in all patients. No complications were observed except for a small laceration and a localized hemodynamically nonsignificant stenosis, without any clinical sequel. CONCLUSIONS: This small case series indicates the feasibility of percutaneous access with the Perclose Proglide system to perform EVAR and peripheral endovascular interventions in the presence of synthetic grafts in the groin, with promising outcomes.

Delayed Complication Secondary to Unsuccessful Deployment of the StarClose Device.

The introduction of vascular closure devices (VCD) such as the StarClose device, has been an innovative step in interventional procedures. Earlier post-procedure ambulation, reduced hematoma formation, the time to hemostasis and the need for blood transfusion have been achievable.1 Few case reports describe complications following deployment of the StarClose device, resulting in acute ischemia. Here we present a unique case of unsuccessful deployment of the StarClose device in a patient following an elective right superficial femoral artery angioplasty, resulting in delayed deterioration of the patient's symptoms, necessitating surgery months after the initial intervention.

Vascular Access Complications and Clinical Outcomes of Vascular Surgical Repairs Following Transcatheter Aortic Valve Implantation (TAVI).

BACKGROUND: Transcatheter aortic valve implantation (TAVI) procedures have revolutionized the treatment of aortic stenosis. However, due to large sheaths, improperly deployed closure devices, and the comorbidities and challenges innate to this population, vascular access complications can be devastating. The objective of this study is to evaluate vascular access complications in one of the largest TAVI sites in North America. METHODS: This was a retrospective single center review between January 2014 and December 2018 of vascular access complications necessitating operative intervention by vascular surgery. Patient demographics and preoperative comorbidities were collected. Type of vascular access complication, types of repair, closure device used, and postoperative outcomes were analyzed. RESULTS: A total of 37 cases out of a total of 985 TAVI procedures were identified. TAVI was carried out in the operating suite (70%) or the catheterization lab (30%). Consults to vascular surgery were requested intraoperatively (60%), immediately postoperative (14%), later in the day of the TAVI (20%), and on postoperative day 1 (6%). The location of injury included common femoral artery (49%), superficial femoral artery (11%) and external iliac artery (41%), with some cases injuring multiple vessels. Closure devices were found in the subcutaneous tissue (26%), anterior wall (37%), posterior wall (11%), intra-arterial (11%), closing the anterior to the posterior wall (16%), and in the inguinal ligament (5%). Injuries included tears (11%), dissections (38%), and vessel rupture (19%). The majority of repairs were done primarily (64%), with patch (28%) and bypass (8%) less frequently. Four patients died perioperatively (11%), 2 from hemorrhage, 1 from cardiac arrest, and 1 from progressive respiratory disease. CONCLUSIONS: Access complications during TAVI procedures predispose complex patients to increased risk of morbidity and mortality. Careful patient selection, proper access techniques, and performing high risk patients in the operating suite with vascular surgery are fundamental in minimizing complications.