Access Site-related Complications Research Articles

Comparison of strategies for vascular ACCESS closure after transcatheter aortic valve implantation: the ACCESS-TAVI randomized trial.

Data from randomized trials investigating different access closure strategies after transfemoral transcatheter aortic valve implantation (TF-TAVI) remain scarce. In this study, two vascular closure device (VCD) strategies to achieve hemostasis after TF-TAVI were compared. The ACCESS-TAVI (Comparison of Strategies for Vascular ACCESS Closure after Transcatheter Aortic Valve Implantation) is a prospective, multicenter trial in which patients undergoing TF-TAVI were randomly assigned to a strategy with a combined suture-/plug-based VCD strategy (suture/plug group) using one ProGlideTM/ProStyleTM (Abbott Vascular) and one Angio-Seal® (Terumo) versus a suture-based VCD strategy (suture-only group) using two ProGlidesTM/ProStylesTM. The primary endpoint was a composite of major or minor access site-related vascular complications during index hospitalization according to Valve Academic Research Consortium (VARC)-3 criteria. Key secondary endpoints included time to hemostasis, VARC-3 bleeding type ≥2 and all-cause mortality over 30 days. Between September 2022 and April 2024, 454 patients were randomized. The primary endpoint occurred in 27% (62/230) in the suture/plug group and 54% (121/224) in the suture-only group (relative risk [RR] 0.55 [95% confidence interval: 0.44;0.68]; p<0.001). Time to hemostasis was significantly shorter in the suture/plug group compared to the suture-only group (108±208 s vs. 206±171 s; p <0.001). At 30 days, bleeding type ≥2 occurred less often in the suture/plug group compared to the sutureonly group (6.2% vs. 12.1%, RR 0.66 [0.43;1.02]; p=0.032), with no significant difference in mortality. With regard to the composite of major or minor access-related vascular complications, a combined suture-/plug-based VCD strategy was superior to a suturebased VCD strategy for vascular access closure in patients undergoing TF-TAVI.

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.

Risk factors for access site-related complications after distal transradial catheterization

Abstract Introduction Distal transradial catheterization (dTRA) has emerged as a viable alternative to conventional transradial access for various interventional procedures. Purpose This study aims to identify the risk factors associated with access site-related complications following dTRA. Methods A total of 4,977 patients who underwent dTRA were included in this retrospective study. The patients were divided into two groups based on the occurrence of access site-related complications: Complication(+) group (n=272) and Complication(-) group (n=4,705). Various demographic, clinical, and procedural parameters were analyzed to identify potential risk factors. Univariate and multivariate logistic regression models were employed to determine the adjusted odds ratios (ORs) and 95% confidence intervals (CIs) for each risk factor. Results The Complication(+) group exhibited a higher prevalence of male gender (53.7% vs. 68.4%, p&amp;lt;0.001), older age (68.140 ± 11.46 vs. 66.33 ± 11.90, p=0.014), lower body mass index (BMI) (24.35 ± 3.54 vs. 24.97 ± 3.55, p=0.005), larger sheath size (2.45 ± 0.24 vs. 2.40 ± 0.24, p&amp;lt;0.001), increased serum creatinine (Cr) levels (1.33 ± 1.76 vs. 1.10 ± 1.46, p=0.013), longer access time (209.26 ± 237.72 vs. 149.26 ± 143.98, p&amp;lt;0.001), prolonged hemostasis time (257.64 ± 202.40 vs. 197.60 ± 133.39, p&amp;lt;0.001), and extended procedure time (32.24 ± 29.07 vs. 23.04 ± 26.19, p&amp;lt;0.001). Additionally, the Complication(+) group received higher heparin doses (6275.48 ± 2971.05 vs. 5282.74 ± 2952.31, p&amp;lt;0.001) and had a higher incidence of multiple antiplatelet therapy (73.2% vs. 51.3%, p&amp;lt;0.001). However, no significant differences were observed in hypertension, dyslipidemia, diabetes mellitus, or smoking history between the two groups. The multivariate analysis identified male gender (adjusted OR: 2.073, 95% CI: 1.376 - 3.123, p&amp;lt;0.001), and increased Cr levels (adjusted OR: 1.083, 95% CI: 1.024 - 1.144, p=0.005) as independent risk factors for access site-related complications after dTRA. Moreover, the use of multiple antiplatelet therapy was found to be significantly associated with an increased risk of complications (adjusted OR: 1.948, 95% CI: 1.420 - 2.671, p&amp;lt;0.001). Conclusion In patients undergoing dTRA, male gender, increased serum creatinine levels, and the use of multiple antiplatelet therapy were identified as independent risk factors for access site-related complications. These findings highlight the importance of careful patient selection and procedural optimization to minimize complications during dTRA.

Peri-procedural anesthesia and patient pain experience in pulmonary vein isolation by means of very high-power short-duration radiofrequency ablation.

Very high-power short-duration (vHPSD) temperature-controlled radiofrequency ablation (vHPSD) may reduce ablation times and improve patient tolerability, permitting pulmonary vein (PV) isolation under mild conscious sedation. We evaluated of the anesthetic drugs use and patients' pain experience during vHPSD PV isolation. Fifty-eight patients, with paroxysmal and persistent atrial fibrillation (AF), treated with QDot Micro catheter and vHPSD (90 w for 4s) (vHPSD group), were compared with the last 33 patients treated with a surround flow contact force-sensing catheter guided by the ablation index (450 anteriorly at 50 W, 330 posteriorly at 40 W) (AI group). Anesthetic drugs use was compared as well as pain experience, measured using a 0-10 scale. All PVs were acutely isolated. Procedural time (78 ± 10min vs 84 ± 12min, p = 0.012), fluoroscopy time (369 ± 139s vs 441 ± 172s, p = 0.03), and RF time in the vHPSD group (8.3 ± 2.1min) were shorter than in the AI group (25 ± 11min, p < 0.001). Only 4 patients experienced an access site-related vascular complication (groin hematoma). Midazolam was required in 36 (62%) vHPSD group patients vs 31 (94%) AI group patients (p < 0.001). Fentanyl was required in 4 (7%) vHPSD group patients vs 25 (76%) AI group patients (p < 0.001). No patients required general anesthesia. Twenty-two (38%) vHPSD group patients underwent PV isolation without any anesthetic drug. Pain experience was significantly lower in vHPSD group (4.9 ± 2 vs 6.6 ± 1.8, p < 0.001). vHPSD radiofrequency ablation for PVI can be performed under conscious sedation using only benzodiazepine in most of patients without compromising patient pain experience.

Preliminary Experience With Novel Straight 3-Fr Guiding Sheath for Transradial Access in Endovascular Treatment: Feasibility and Safety.

Radial artery diameter may limit whether a guiding sheath (GS) can be used via transradial artery access (TRA). A smaller GS may reduce the risk of access site-related complications. This study investigated the feasibility and safety of endovascular treatment (EVT) using a straight-shaped 3-Fr GS (Axcelguide; Medikit). Patients who underwent EVT with a straight-shaped 3-Fr GS at 3 institutions between April 2022 and March 2024 were retrospectively reviewed. Patient background, anatomic and procedural factors, and complications were recorded. Twenty-six pathologies were treated with EVT using a 3-Fr GS. Median radial artery diameter was 1.9 mm, and distal TRA (73.1%) was selected more often than TRA (26.9%) as the access site. The breakdown of target pathologies and the role of the 3-Fr GS were as follows: 12 unruptured cerebral aneurysms for intra-aneurysmal coiling, with 5 dural arteriovenous fistulas, 5 brain or head and neck tumors, 2 chronic subdural hematoma, 1 arteriovenous malformation, and 1 hereditary hemorrhagic telangiectasia for transarterial embolization. A success rate of 96.2% was achieved, with no access site- or non-access site-related complications observed within 30 days. The straight-shaped 3-Fr GS may be applicable for selected pathologies, allowing access even with RAs <2 mm in diameter and facilitating EVT without complications. Preliminary experience with the 3-Fr GS via TRA demonstrated excellent feasibility and safety.

Results from a multicenter retrospective study of transradial iliac artery stenting in Japan.

Large-scale multicenter studies demonstrating the safety and effectiveness of transradial iliac artery stenting are lacking. We evaluated the data from a multicenter database in Japan. Transradial iliac artery stenting was performed on 115 lesions in 105 patients. The approach site was determined at the discretion of the operator. Patients with scheduled multiple sheath insertions for the bidirectional approach were excluded. Clinical data were retrospectively analyzed. The average age of this cohort was 71.1 ± 8.3years. Eighty-six patients (81.9%) were male. Diabetes mellitus, hypertension, dyslipidemia, and smoking habit were present in 39 (37.1%), 84 (80.0%), 69 (65.7%), and 78 patients (74.3%), respectively. Rutherford classifications 1, 2, 3, 4, and 5 comprised 40 (34.8%), 42 (36.5%), 28 (24.3%), 3 (2.6%), and 2 (1.7%) lesions, respectively, while Trans-Atlantic Inter-Society Consensus II classifications A, B, C, and D comprised 74 (64.3%), 21 (18.3%), 15 (13.0%), and 5 (4.3%), respectively. Twenty-seven lesions (23.5%) had chronic total occlusion. All lesions were successfully treated with 141 stents. Four patients (3.8%) required additional puncture of the common femoral artery for successful stent implantation. The ankle-brachial index significantly improved from 0.65 ± 0.17 to 0.95 ± 0.15 (P < 0.0001). None of the patients experienced any procedural or access site-related complications. Asymptomatic radial artery occlusion was observed in three cases (2.9%) after the procedure. There were no target lesion revascularizations or complications at 1month. Compared to the traditional transfemoral approach, transradial iliac artery stenting is safe and feasible without any specific complications in carefully selected patients.

Upper extremity versus lower extremity for secondary access during transcatheter aortic valve implantation: rationale and design of the randomised TAVI XS trial.

During transcatheter aortic valve implantation (TAVI), secondary access is required for angiographic guidance and temporary pacing. The most commonly used secondary access sites are the femoral artery (angiographic guidance) and the femoral vein (temporary pacing). An upper extremity approach using the radial artery and an upper arm vein instead of the lower extremity approach using the femoral artery and femoral vein may reduce clinically relevant secondary access site-related bleeding complications, but robust evidence is lacking. The TAVI XS trial is amulticentre, randomised, open-label clinical trial with blinded evaluation of endpoints. Atotal of 238 patients undergoing transfemoral TAVI will be included. The primary endpoint is the incidence of clinically relevant bleeding (i.e. Bleeding Academic Research Consortium (BARC) type2, 3or 5bleeding) of the randomised secondary access site (either diagnostic or pacemaker access, or both) within 30days after TAVI. Secondary endpoints include time to mobilisation after TAVI, duration of hospitalisation, any BARC type2, 3or 5bleeding, and early safety at 30days according to Valve Academic Research Consortium‑3 criteria. The TAVI XS trial is the first randomised trial comparing an upper extremity approach to alower extremity approach with regard to clinically relevant secondary access site-related bleeding complications. The results of this trial will provide important insights into the safety and efficacy of an upper extremity approach in patients undergoing transfemoral TAVI.

Feasibility and efficacy of real-time ultrasound-guided venous closure with suture-mediated vascular closure device

BackgroundVenous vascular access complications are usually nonfatal but are the most common complications after transvenous catheter intervention. Vascular closure devices (VCDs) have recently become available for venous closure. ObjectiveThis study aimed to evaluate the feasibility and efficacy of real-time ultrasound-guided venous closure with suture-mediated VCDs in patients who underwent catheter ablation. MethodsThis single-center observational study enrolled 226 consecutive patients who underwent elective catheter ablation with femoral venipuncture. For hemostasis, vessel closure by VCD was performed with real-time ultrasound guidance after 2022 (n = 123) and without ultrasound guidance in 2021 (n = 103). The occurrence of venous access site–related complications (major, minor, or other) was compared. ResultsThe rate of device failure was significantly lower in patients with ultrasound guidance than in those without (1.6% vs 6.3%; P = .048). The occurrence of all venous access site–related complications was significantly lower in patients with ultrasound guidance than in those without (4.9% vs 18.4%; P = .001). Time to ambulation was shorter in patients with ultrasound guidance than in those without (2.0 ± 0.1 hours vs 2.2 ± 0.6 hours; P < .001). ConclusionReal-time ultrasound guidance can reduce device failure, access site–related complications, and time to ambulation in performing venous closure with a VCD.

Distal Versus Proximal Radial Arterial Access for Percutaneous Coronary Angiography and Intervention: Updated Meta-Analysis of Randomized Controlled Trials

Radial artery occlusion (RAO) is a major impediment to reintervention in patients who underwent proximal transradial access (p-TRA) for coronary catheterization. Distal transradial access (d-TRA) at the level of snuffbox distal to the radial artery bifurcation is a novel alternative to p-TRA. We conducted an updated meta-analysis of all available randomized controlled trials (RCTs) to compare the incidence of RAO between p-TRA and d-TRA, along with access site-related complications. PubMed, Web of Science, and Google Scholar were searched for RCTs published since 2017 to October 2023 comparing d-TRA and p-TRA for coronary angiography and/or intervention. Risk ratios (RRs) and mean differences (MDs) with 95% confidence intervals were calculated using the random-effects model for procedural and clinical outcomes for the 2 approaches. A total of 18 RCTs with 8,205 patients (d-TRA n = 4,096, p-TRA n = 4,109) were included. The risk of RAO (RR 0.31, 0.21 to 0.46, p ≤0.001) and time to hemostasis (minutes) (MD -51.18, -70.62 to -31.73, p <0.001) was significantly lower in the d-TRA group. Crossover rates (RR 2.39, 1.71 to 3.32, p <0.001), access time (minutes) (MD 0.93, 0.50 to 1.37, p <0.001), procedural pain (MD 0.46, 0.13 to 0.79, p = 0.006), and multiple puncture attempts (RR 2.13, 1.10 to 4.11, p = 0.03) were significantly higher in the d-TRA group. The use of d-TRA for coronary angiography and/or intervention is associated with a lower risk of RAO at the forearm and may preserve p-TRA site for reintervention in selective patients by reducing the incidence of RAO.

Strategies to Minimize Access Site-related Complications in Patients Undergoing Transfemoral Artery Procedures with Large-bore Devices.

Large bore accesses refer to accesses with a diameter of 10 French or greater and are necessary for various medical devices, including those used in transcatheter aortic valve replacement, endovascular aneurysm repair stent-grafts, and percutaneous mechanical support devices. Notably, the utilization of these devices via femoral access is steadily increasing due to advancements in technology and implantation techniques, which are expanding the pool of patients suitable for percutaneous procedures. However, procedures involving large bore devices carry a high risk of bleeding and vascular complications (VCs), impacting both morbidity and long-term mortality. In this review article, we will first discuss the incidence, determinants, and prognostic impact of VCs in patients undergoing large bore access procedures. Subsequently, we will explore the strategies developed in recent years to minimize VCs, including techniques for optimizing vascular puncture through femoral cannulation, such as the use of echo-guided access cannulation and fluoroscopic guidance. Additionally, we will evaluate existing vascular closure devices designed for large bore devices. Finally, we will consider new pharmacological strategies aimed at reducing the risk of periprocedural access-related bleeding.

Distal Radial Access for Coronary Procedures in a Large Prospective Multicenter Registry: The KODRA Trial

BackgroundDistal radial access (DRA) as an alternative access route lacks evidence, despite its recent reputation. ObjectivesThe aim of this study was to evaluate the safety and feasibility of DRA on the basis of daily practice. MethodsThe KODRA (Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach) trial was a prospective multicenter registry conducted at 14 hospitals between September 2019 and September 2021. The primary endpoints were the success rates of coronary angiography (CAG) and percutaneous coronary intervention (PCI). The secondary endpoints included successful distal radial artery puncture, access-site crossover, access site–related complications, bleeding events, and predictors of puncture failure. ResultsA total of 4,977 among 5,712 screened patients were recruited after the exclusion of 735 patients. The primary endpoints, the success rates of CAG and PCI via DRA, were 100% and 98.8%, respectively, among successful punctures of the distal radial artery (94.4%). Access-site crossover occurred in 333 patients (6.7%). The rates of distal radial artery occlusion and radial artery occlusion by palpation were 0.8% (36 of 4,340) and 0.8% (33 of 4,340) at 1-month follow-up. DRA-related bleeding events were observed in 3.3% of patients, without serious hematoma. Multilevel logistic regression analysis identified weak pulse (OR: 9.994; 95% CI: 7.252-13.774) and DRA experience <100 cases (OR: 2.187; 95% CI: 1.383-3.456) as predictors of puncture failure. ConclusionsIn this large-scale prospective multicenter registry, DRA demonstrated high success rates of CAG and PCI, with a high rate of puncture success but low rates of distal radial artery occlusion, radial artery occlusion, bleeding events, and procedure-related complications. Weak pulse and DRA experience <100 cases were predictors of puncture failure. (Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach [KODRA]; NCT04080700)

Octogenarians fare better under local anesthesia for elective endovascular aortic aneurysm repair

ObjectiveWith an aging patient population, an increasing number of octogenarians are undergoing elective endovascular abdominal aortic aneurysm repair (EVAR) in the United States. Multiple studies have shown that, for the general population, use of local anesthetic (LA) for EVAR is associated with improved short-term and long-term outcomes as compared with performing these operations under general anesthesia (GA). Therefore, this study aimed to study the association of LA for elective EVARs with perioperative outcomes, among octogenarians. MethodsThe Vascular Quality Initiative database (2003-2021) was used to conduct this study. Octogenarians (Aged ≥80 years) were selected and sorted into two study groups: LA (Group I) and GA (Group II). Our primary outcomes were length of stay and mortality. Secondary outcomes included operative time, estimated blood loss, return to operating room, cardiopulmonary complications, and discharge location. ResultsOf the 16,398 selected patients, 1197 patients (7.3%) were included in Group I, and 15,201 patients (92.7%) were in Group II. Procedural time was significantly shorter for the LA group (114.6 vs 134.6; P < .001), as was estimated blood loss (152 vs 222 cc; P < .001). Length of stay was significantly shorter (1.8 vs 2.6 days; P < .001), and patients were more likely to be discharged home (LA 88.8% vs GA 86.9%; P = .036) in the LA group. Group I also experienced fewer pulmonary complications; only 0.17% experienced pneumonia and 0.42% required ventilator support compared with 0.64% and 1.02% in Group II, respectively. This finding corresponded to fewer days in the intensive care unit for Group I (0.41 vs 0.69 days; P < .001). No significant difference was seen in 30-day mortality cardiac, renal, or access site-related complications. Return to operating room was also equivocal between the two groups. Multivariate regression analysis confirmed GA was associated with a significantly longer length of stay and significantly higher rates of non-home discharge (adjusted odds ratio [AOR], 1.59; P < .001 and AOR, 1.40; P = .025, respectively). When stratified by the New York Heart Association classification system, classes I, II, III, and IV (1.55; P < .001; 1.26; P = .029; 2.03; P < .001; 4.07; P < .001, respectively) were associated with significantly longer hospital stays. ConclusionsThe use of LA for EVARs in octogenarians is associated with shorter lengths of stay, fewer respiratory complications, and home discharge. These patients also experienced shorter procedure times and less blood loss. There was no statistically significant difference in 30-day mortality, return to operating room, or access-related complications. LA for octogenarians undergoing EVAR should be considered more frequently to shorten hospital stays and decrease complication rates.

Comparing Planned Surgical versus Percutaneous Access Vascular Outcomes and Complications in Patients Undergoing Transcatheter Aortic Valve Implantation

Abstract Background Increased expertise and technical advancements lead to a significant reduction of major access site-related vascular complications that occur, nowadays Post and intra-procedural in &amp;lt; 10% of cases. Due to its wide diffusion and feasibility, the trans-femoral access is the preferred route in the majority of the clinical trials and is recommended as first choice by all guidelines and consensus documents, as vascular complications are a non-comparable factor to traditional SAVR so it is a new side effect that has emerged with TAVI that is in need to be minimized. Aim The aim of this work is to compare surgical versus percutaneous access peripheral vascular outcomes in TAVI procedure during hospital stay. Patients and Methods This was a Comparative cross-sectional study that was conducted at Ain Shams university hospitals &amp; Helwan university hospital this study included 68 retrospective and prospective patients that were scheduled for TAVI 29 with percutaneous access followed by device closure (Proglide) and 37 surgical cut-down patients followed by surgical closure. Result A total of 68 patients were enrolled, 34 patients were females (50 %) and 34 patients were males (50 %). Their age ranged from 65-97 years with mean age (75.12) years. Patients in this study are classified into 2 groups: Group I: included patients who did the procedure with percutaneous vascular approach followed by device closure. Group II: included patients included patients who did the procedure with surgical cutdown vascular approach. Conclusion There is no significant difference in vascular complications between the 2 approaches indicating that whenever closure devices (Proglide) are available it can be used safely on patients undergoing TAVI, a more dedicated closure device to larger puncture sites such as MANTA should be properly studied as a promising step. Recommendation Larger studies with increased sample size are recommended for proper evaluation of intra and post procedural predictors of vascular complications. Further studies on the new MANTA device as it is a dedicated device to larger puncture sites. Long-term follow up.

Percutaneous VA-ECMO from Cannulation to Decannulation: Novel Use of a Vascular Closure Device in Pediatrics.

VA-ECMO can be lifesaving in cardiogenic shock in children. While surgical vascular repair is the current standard of care for decannulation, it comes with notable risks. We present a series of eight patients who underwent decannulation with a collagen plug-based vascular closure device (MANTA) for the common femoral artery. Seven of the patients were successfully decannulated without access site-related vascular complications. One required conversion to surgical cut-down with arterial repair due to device failure. This series demonstrates the successful use of the MANTA device in percutaneous VA-ECMO decannulation in the pediatric population, while highlighting potential technical challenges for success.

Efficacy and Safety of Low-Dose Protamine in Reducing Bleeding Complications during TAVI: A Propensity-Matched Comparison

Objectives: We aimed to evaluate the efficacy and safety of low-dose protamine in reducing access site-related complications during Transcatheter Aortic Valve Implantation (TAVI) as compared to full-dose protamine. Background: Access site-related complications represent an independent predictor of poor outcomes of TAVI. Data regarding heparin reversal with protamine and the dosage needed to prevent bleeding complications are scarce among patients undergoing TAVI. Methods: A total of 897 patients were retrospectively included in the study. Patients who underwent percutaneous coronary intervention within 4 weeks before or concomitantly with TAVI (n = 191) were given 0.5 mg protamine for each 100 units of unfractionated heparin. All other patients (n = 706) were considered as a control group and 1 mg protamine for each 100 units of heparin was administered. Results: The combined intra-hospital endpoint of death, life-threatening major bleeding, and major vascular complications were significantly more frequent in patients receiving low-dose protamine [29 (15.2%) vs. 50 (7.1%), p &lt; 0.001]. After propensity matching (n = 130 for each group) for relevant clinical characteristics including anti-platelet therapy [19 (14.6%) vs. 6 (4.6%), p = 0.006], low-dose protamine predicted the combined endpoint (OR 3.54, 95%-CI 1.36–9.17, p = 0.009), and even in multivariable analysis, low-dose protamine continued to be a predictor of the combined endpoint in the matched model (OR 3.07, 95%-CI 1.17–8.08, p = 0.023) alongside baseline hemoglobin. Conclusions: In this propensity-matched retrospective analysis, a low-dose protamine regime is associated with a higher rate of major adverse events compared to a full-dose protamine regime following transfemoral TAVI.

Distal radial artery access is a safe and feasible technique in the anatomical snuffbox for visceral intervention.

Regarding the site of arterial access during the intervention, transracial intervention can reduce the risk of bleeding and vessel-related complications as well as improve patient comfort. Importantly, the distal radial artery (DRA) approach may reduce the incidence of radial artery occlusion and digital ischemia, but the feasibility and safety of DRA in performing subdiaphragmatic vascular interventions remain unclear. From January 2018 to December 2019, 106 patients were admitted to our department for visceral angiography and intervention by left distal radial artery accessing in an anatomical snuffbox. In total, 152 times of vascular interventions were performed during this period. Patients demographics, procedure details, technical success, and access site-related complications were recorded and evaluated. The mean age was 58.9 (range 22-86) years. Males accounted for 80.2%. Thirty-five patients (33%) had 2 or more procedures via the DRA approach. Technical success was achieved for 96.1% of procedures (146 cases) and 3.9% of cases failed to perform the intended procedure via the DRA approach (6 cases). The 4-Fr sheath was used in 86.8% of cases, and the 5 Fr sheath was used in the rest of the 13.2% of procedures. The rate of asymptomatic radial artery occlusion was 5.7% (6 of 106 patients). No patient suffered from distal limb ischemia after a long-time follow-up. Eight patients suffered postoperative local pain, transient numbness, or local bruised in the anatomical snuffbox without major complications. Patients with postoperative complications recovered quickly by using nonsteroidal anti-inflammatory drugs or without further treatment. Left distal radial artery access is safe and feasible as a new technique for visceral angiography and intervention.

Head and neck angiography in the pediatric population: single-center experience with indications, safety, feasibility, and technical differences among infants, childhood, and adolescents.

Pediatric patients are candidates for head and neck endovascular procedures less frequently than adults. Data on utilization, feasibility, safety, and technical details of head and neck angiography in the pediatric population are scarce. The authors performed a retrospective review of their center's endovascular database to identify all patients ≤ 18 years of age who underwent diagnostic or interventional catheter-based angiography of the head and neck. Procedure-related variables for identified patients were compared across infancy (birth to 2 years), childhood (> 2-11 years), and adolescence (> 11-18 years). One hundred twenty-one pediatric patients who underwent 274 angiogram procedures were included in this study. Of these angiograms, 197 were diagnostic and 118 were interventional (including 41 of the diagnostic angiogram procedures that were performed concurrently with the intervention). The most common indications for diagnostic angiograms were suspected vascular malformations in 52 cases (26.4%) and aneurysms in 23 (11.7%). The rate of positive findings on diagnostic angiograms ranged from 27.3% to 80% according to the indication. Access site-related complications were observed after 2 punctures (0.7%). Procedure-related complications occurred in 3 patients (1.1%). In adolescents, the rates of general anesthesia use and sheathless access were significantly lower (each p < 0.001), and the rates of radial artery access (p < 0.001); 5-French (5F) (p = 0.01), 6F (p < 0.001), and 8F (p = 0.03) access; and closure device usage (p < 0.001) were significantly higher. In infants, the rates of ultrasound guidance, 4F access, and failure of the primary puncture site were significantly higher (each p < 0.001). Head and neck angiograms in the pediatric population were feasible and safe in the authors' overall experience. Technical differences were observed across the infant, childhood, and adolescent groups, but safe outcomes were similar throughout these age ranges.

Abstract Number ‐ 81: Safety and Efficacy of Trans‐carotid Intervention in Multiple Scenarios: Medellin Experience Direct Carotid access.

Introduction Direct carotid puncture has been validated such as an alternative route to reach the intracranial vasculature. However, this approach has not been considered routinely in INR. A believe of higher risk for neurovascular procedures or major accesssite related complications restrict its use. This study was conducted to investigate the feasibility and safety of trans carotid Neurointervention for a variety of pathologies. Methods Since 2018 we implemented a direct carotid access under special considerations to perform a therapeutic approach. A total of 14 patients from our centers were analyzed. Patients were divided into a variety of neurovascular conditions: Carotid Stenting CAS (n = 2), Mechanical Thrombectomy MT (n = 5), AVM´s treatment (n = 2), intracranial Aneurysms treatment (n = 5). Patient demographics, technical data, intervention time, type of intervention, closure device used, local or systemic complications and a patient perception assessment were registered. Results Mean age was 64.3 ± 10.3 years. all cases but two we treated the patients under General Anesthesia GA. Major indication to this approach was : anatomical and access limitations. (in 12 cases wasn’t possible to reach the ICA through femoral or radial access due to extreme aortic arc tortuosity. Two patients with Leriche Syndrome) All cases performed with ultrasound US assistance. A 4 Fr. Micro‐ puncture set were used in all procedures and posteriorly a 6Fr. Introducer was inserted. Technical success in all cases (100%). Two patients presented mild vasospasm and resolved using IA vasodilators. Both CAS were performed without any complications and none embolic protection device used. For MT(n = 5): a SOFIA 6Fr for ADAPT was used in 3 cases with TICI 2b‐3 in all cases. Combined approach ¨Solumbra¨ solitaire and aspiration catheter was used in two cases, one TICI 2a and one TICI 3. For the AVM´s treatment we use a 6Fr guiding catheter and non‐detachable microcatheters to inject Onix with a high grade of obliteration. Five aneurysms were treated with this approach (2 ICA – ophthalmic; 2 MCA and one AcomA) Mean average time of the procedure was 34.5 min. (ranged 9–59 min) just one bleeding complication observed at the closure device use. In all cases but one we use Angio‐Seal 6Fr as closure device, in a single case where we used a ProGlide suture device we had a serious complication at the puncture site. Conclusions Trans Carotid Intervention TCI. was feasible and safe in selected patients in this small series. A multiple variety of neurovascular conditions would be treated successfully by this way improving the learning curve. Complication rates and clinical outcomes were comparable with those in trans femoral or radial approach.

Vascular Access in Patients With Peripheral Arterial Disease Undergoing TAVR: The Hostile Registry

BackgroundThe optimal access route in patients with severe peripheral artery disease (PAD) undergoing transcatheter aortic valve replacement (TAVR) remains undetermined. ObjectivesThis study sought to compare clinical outcomes with transfemoral access (TFA), transthoracic access (TTA), and nonthoracic transalternative access (TAA) in TAVR patients with severe PAD. MethodsPatients with PAD and hostile femoral access (TFA impossible, or possible only after percutaneous treatment) undergoing TAVR at 28 international centers were included in this registry. The primary endpoint was the propensity-adjusted risk of 30-day major adverse events (MAE) defined as the composite of all-cause mortality, stroke/transient ischemic attack (TIA), or main access site–related Valve Academic Research Consortium 3 major vascular complications. Outcomes were also stratified according to the severity of PAD using a novel risk score (Hostile score). ResultsAmong the 1,707 patients included in the registry, 518 (30.3%) underwent TAVR with TFA after percutaneous treatment, 642 (37.6%) with TTA, and 547 (32.0%) with TAA (mostly transaxillary). Compared with TTA, both TFA (adjusted HR: 0.58; 95% CI: 0.45-0.75) and TAA (adjusted HR: 0.60; 95% CI: 0.47-0.78) were associated with lower 30-day rates of MAE, driven by fewer access site–related complications. Composite risks at 1 year were also lower with TFA and TAA compared with TTA. TFA compared with TAA was associated with lower 1-year risk of stroke/TIA (adjusted HR: 0.49; 95% CI: 0.24-0.98), a finding confined to patients with low Hostile scores (Pinteraction = 0.049). ConclusionsAmong patients with PAD undergoing TAVR, both TFA and TAA were associated with lower 30-day and 1-year rates of MAE compared with TTA, but 1-year stroke/TIA rates were higher with TAA compared with TFA.

Compressão pneumática prolongada e guiada por ultrassom de um pseudoaneurisma da artéria radial após intervenção coronariana percutânea: solução simples e eficaz para um problema raro e desafiador

Abstract Transradial access is associated with fewer access site-related complications, earlier patient mobilization, and greater postprocedural comfort. Pseudoaneurysms are an extremely rare complication after transradial procedures and the radial artery itself is the most atypical arterial site of occurrence. We report a case in which a non-surgical, non-invasive, simple, and effective solution (prolonged pneumatic compression) was used to manage a radial artery pseudoaneurysm, a very rare and challenging complication of transradial procedures.