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

BACKGROUND: 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. AIMS: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.

A Novel Risk Score Facilitates Femoral Artery Access in Transcatheter Aortic Valve Implantation: Passage-Puncture Score.

Background: Vascular complications remain high in transfemoral transcatheter aortic valve implantation (TAVI). Careful evaluation of the femoral arteries is important to select the optimal access site. Objectives: This study sought to describe a novel risk score (the passage-puncture score) for transfemoral access using a single suture-based closure system. Methods: The passage-puncture score consists of the evaluation of 1) passage feasibility of the ilio-femoral arteries (passage score) and 2) puncture site feasibility (puncture score) based on pre-TAVI computed tomography. All patients underwent fluoroscopy-guided arterial puncture and closure with a suture-based closure system. The primary endpoint was the rate of vascular complications in discharge, including minor and major vascular complications according to the definitions of the Third Valve Academic Research Consortium. Results: From September 2020 to June 2021, transfemoral TAVI was performed in 98 of 99 patients. Passage score (right) was significantly higher in patients treated by left compared to those treated by right femoral access (3 vs. 1; p <0.001). Puncture score was significantly different between patients undergoing mid-femoral as compared to nonmid-femoral puncture (0 vs. 3, p <0.001). Minor vascular complications occurred in six (6%) patients. Conclusions: The passage-puncture score is effective in defining the optimal access site for transfemoral TAVI. The systematic evaluation has the potential to further reduce access-site complications.

Endovascular Perclose ProGlide complication puncture site, treated successful by cutting balloon dilatation: A case report and literature review.

Perclose ProGlide were created as preferred for puncture site closure of femoral artery. Femoral artery occlusion is one of the serious device-related complications. This report presents a continuous endovascular technique combined with peripheral cutting balloon (PCB) treatment for a case of a 32s woman diagnosed with lower extremity ischaemia caused by right superficial femoral artery (SFA) occlusion following the use of the Perclose ProGlide system in minimally invasive cardiac surgery. During the primary operation, limb ischaemia symptoms were relieved with vessel perfusion and reconstruction after regular balloon dilatation. A secondary operation was conducted 6 weeks later, and the obstructive lesions were recanalised without residual stenosis after PCB dilatation. No vessel-related adverse events such as dissection, rupture or distal embolisation occurred during the perioperative period. The patient recovered uneventfully after the operation, with complete alleviation of symptoms. Follow-up computed tomography angiography 3 month post-operatively revealed an undeformed shape and excellent patency of the right SFA.

Collagen-Based Vascular Closure Device Multicenter Italian Experience in Endovascular Aortic Aneurysm Repair Compared With Suture-Mediated Closure Vascular Device.

PURPOSE: The Manta Vascular Closure Device is a novel collagen-based vascular closure device that has been designed specifically for closure of large-bore percutaneous arterial accesses. The aim of this retrospective study is to evaluate the immediate and 30-day outcome of Manta at the completion of endovascular aneurysm repair (EVAR) or thoracic endovascular aortic repair (TEVAR). The hypothesis is that Manta is not inferior in obtaining hemostasis compared with the Perclose ProGlide Suture-Mediated Closure System device. MATERIALS AND METHODS: We recruited all the percutaneous accesses for (T)EVAR performed from January 2021 to April 2023 by all the Italian Divisions of Vascular Surgery using Manta at the time of data collection (May 2023). The primary outcome is to evaluate the incidence of complications at the puncture site after Manta implantation and at 1 month, and compare this with ProGlide. We applied the STROBE (Strengthening the Reporting of Observational Studies in Epidemiology) criteria for observational studies. RESULTS: Overall, 524 consecutive femoral accesses for (T)EVAR procedures were collected: 355 in the Manta cohort and 169 in the ProGlide cohort, respectively. The size of the sheath was 17.2±2.7 Fr for Manta, 15.7±2.3 Fr for ProGlide (p<0.001). No statistically significant differences between the groups regarding age, sex, body mass index, ultrasound-guided access, femoral calcifications, intraoperative, and 30-day complications. Successful arterial closure at groin puncture sites for (T)EVAR using Manta is 90.5% and 93.1% using ProGlide. Freedom for any reintervention for any complication is 95.5% for Manta and 96% for ProGlide. CONCLUSION: The 2 vascular closure devices have proved to be similar in terms of complications, without any statistically significant difference, although the median size of the sheaths for (T)EVAR was statistically significantly larger when Manta has been used, compared with ProGlide. CLINICAL IMPACT: Manta® is effective in the hemostasis of the access sites following the completion of (T)EVAR in this multicenter, retrospective, case-control study on 524 percutaneous femoral accesses. Compared to the more popular Proglide®, the average size of the introducers in the Manta® group was significantly larger than in the Proglide® group.

Acute lower limb ischemia caused by repeat deployment of vascular closure device.

Vascular closure devices are used to facilitate faster hemostasis and earlier ambulation, improve patient comfort, and reduce length of hospital stay after percutaneous endovascular procedures. However, their use may rarely be associated with limb ischemia due to endothelial damage and arterial thrombosis. This report illustrates the case of a patient who experienced acute lower limb ischemia due to superficial femoral artery occlusion caused by repeat closure with Angio-Seal vascular closure device within 30 days in a small-caliber superficial femoral artery. The patient was surgically treated by vascular repair with a synthetic graft, and remains symptom-free in 3-year follow-up. Repeat deployment of vascular closure devices in the same access site within a period of 30 days may cause acute limb ischemia due to arterial thrombosis, especially in patients with small-caliber arteries, even in the absence of evident risk factors.

Preliminary Insights Into Early Ambulation and Hemostasis After Atrial Fibrillation Ablation Using the Perclose Vascular Closure Device.

Background: The introduction of the Perclose vascular closure device (VCD) for atrial fibrillation (AF) ablation procedures in Japan is expected to facilitate early ambulation. Methods and Results: The study population comprised 554 patients undergoing AF ablation, of whom 377 successfully underwent Perclose VCD deployment at the end of the procedure. At 4 h after the procedure, 94% (353/377 patients) achieved early hemostasis and 57% (213/377 patients) achieved early ambulation. Notably, 0.5% (2/377 patients) developed acute deep vein thrombosis. Conclusions: The Perclose VCD demonstrated promising efficacy in achieving early hemostasis, potentially facilitating early ambulation and discharge in appropriate patients.

Hepatic and splenic venous access tract closure using the VASCADE vascular closure system following percutaneous intervention in patients with CHD.

BACKGROUND: Hepatic and splenic venous access are specialised techniques used to perform diagnostic and interventional procedures in the cardiac catheterisation laboratory. Bleeding events are the most commonly reported complication following hepatic or splenic venous access. The VASCADE Vascular Closure System (Cardiva Medical Inc. Santa Barbara, CA) is an approved device for closure of femoral vascular access tracts in patients ≥18 years of age. We report our experience using VASCADE to close the hepatic or splenic venous access site in the cardiac catheterisation laboratory. METHODS: This is a single centre retrospective review of all patients who had percutaneous hepatic or splenic venous access obtained in the cardiac catheterisation laboratory from March 1, 2022 through October 30, 2023 and underwent tract closure with VASCADE. RESULTS: Ten patients (six male) underwent 16 procedures (median age and weight 3.5 years and 12.5 kg) with 15 hepatic and two splenic veins accessed. Successful closure of the access tracts with VASCADE was performed in all patients. There were no major adverse events related to closure of the access sites with VASCADE. CONCLUSION: VASCADE can be used following transhepatic and trans-splenic venous access in the cardiac catheterisation laboratory to safely close the access tract and potentially reduce the risk of post-procedural bleeding complications. Further evaluation in a larger cohort of patients is needed to ensure VASCADE is safe for use and provides adequate haemostasis following hepatic or splenic venous access, particularly in children.

ESR Essentials: arterial vascular access and closure devices-practice recommendations by the Cardiovascular and Interventional Radiological Society of Europe.

Vascular access is the initial, very important, step of endovascular procedures. Various access sites include the common femoral artery, brachial artery, radial artery, popliteal artery, and distal tibial vessels (pedal arteries). Successful arterial access requires advanced knowledge of anatomy, as well as proper training and experience. Today, vascular access should be obtained using real-time, ultrasound guidance to reduce access time, patient discomfort, and puncture-related complications including dissection, arteriovenous communication, and bleeding. Nevertheless, high-level evidence to support this recommendation in peripheral procedures is limited and level A data are mainly derived from randomized cardiac trials investigating only radial and femoral access. Vascular closure devices (VCDs) for femoral access can be broadly categorized as active closure devices, compression assist devices, and external/topical hemostasis devices. There is high-level evidence demonstrating that their use is related to less time for ambulation and increased patient satisfaction. However, available data failed to clearly demonstrate a benefit in complications compared to standard manual compression in peripheral endovascular arterial procedures, and thrombotic and infectious complications reported following VCD use remain an issue. Heterogeneity noted in the literature, caused by the vast variety of devices, access sites, sheath sizes, clinical scenarios, and procedures, poses difficulties in data analysis and future study design. As a result, an individualized VCD use is currently suggested for ≥ 5 Fr femoral artery access not only to reduce time to hemostasis and ambulation and to improve patient comfort, but also to reduce bleeding complications in cases of femoral access with increased bleeding risk, deranged coagulation, and large-bore access, though a high level of evidence to support this later recommendation is limited. KEY POINTS: US guidance is strongly recommended for femoral access and is mandatory to obtain more challenging access. The use of VCDs for femoral hemostasis is generally safe, effective, and currently supported by level I evidence. Proper training and correct VCD choice, based on the patient's individual characteristics, are imperative to optimize outcomes.

Procedure-Related Complication Rates With the Use of Vascular Closure Devices; Does Size Only Matter? A Large Single Centre Retrospective Study.

INTRODUCTION: Our retrospective study aimed at assessing safety of vascular closure devices (VCDs) used in a large single-centre Interventional Radiology (IR) department. Complication and deployment failure rates using collagen-based (Angio-seal) and suture-based (ProGlide) devices for common femoral artery haemostasis were compared. MATERIALS AND METHODS: Data from VCDs deployed over a 6-year period were retrospectively analysed for patient age, procedure indication, puncture mode (antegrade/retrograde), sheath size, deployment failure and complications (haematoma, pseudoaneurysm formation, limb occlusion). Numerical and statistical analysis was undertaken. RESULTS: Overall, 1321 common femoral artery punctures in 1217 patients were closed using VCDs. Failure rate using ProGlide was significantly higher when compared with Angio-seal (P=<0.001) in sheath sizes ≤8 Fr. Heparin was not administered in embolisation procedures compared with angioplasty with or without stenting. Therefore, haematoma tended to occur more frequently following angioplasty without stenting (P = 0.003) and angioplasty with stenting (P = 0.001), when compared with embolisation. Deployment failure occurred more frequently when heparin was used during the procedure (P = 0.005). CONCLUSION: Although complications relating to sheath size are well established in the literature, there remains a paucity of data assessing the impact of procedure specific factors when comparing VCDs. Our study challenges that size is the sole determinant of VCD success and invites a more holistic view of VCD deployment strategies. This study advocates continued research into the nuances of other potential confounding variables to optimise patient outcomes.

Compare efficacy and safety of autologous blood clot injection with C-clamp vascular closure device in treatment of iatrogenic pseudoaneurysm after femoral artery puncture.

INTRODUCTION: Iatrogenic femoral artery pseudoaneurysm (FAP) is a complication following femoral artery puncture, with an incidence rate of 0.2%-5.5% post-cardiac catheterization procedures. Management typically involves observation or interventional treatments such as ultrasound-guided compression (UGC) or ultrasound-guided thrombin injections. This study compares the efficacy and safety of ultrasound-guided autologous blood clot injection (UGCI) with C-clamp vascular closure device-assisted UGC in treating FAP. MATERIALS AND METHODS: Conducted at a high-volume training and research center, this prospective study enrolled patients with iatrogenic FAP post-femoral artery puncture. Patients were randomized into two treatments: UGC with a C-clamp device or UGCI. Primary endpoints were thrombosis induction within 24 h, average procedure time, and length of hospital stay (LOS). RESULTS: The study included 105 patients with 51 undergoing UGCI and 54 undergoing UGC. UGCI achieved a primary success rate of 96% versus 63% for UGC. The mean procedure duration for UGCI was significantly shorter (22 min) compared with UGC (49 min, p ⩽ 0.0001). LOS was also reduced in the UGCI group (1.5 days) compared to the UGC group (4.5 days). Complication rates were low for both procedures, with one deep vein thrombosis and one infection observed in the UGC group. CONCLUSION: UGCI demonstrated to be a safe, efficient, and faster alternative for treating iatrogenic FAPs with a higher success rate, reduced LOS, and similar low complication rates compared to UGC. This study suggests that UGCI could be considered a preferred method for the management of FAP post-femoral artery catheterization.

Angio-Seal Closure for Traumatic Left Subclavian Artery Pseudoaneurysm: A Case Report.

Subclavian artery pseudoaneurysms are rare and associated with high morbidity and mortality. Alternative approaches to open surgical repair can include endovascular repair or ultrasound-guided thrombin injection. Here, we describe a safe and novel technique of closure of a subclavian artery pseudoaneurysm with Angio-Seal that was unresponsive to thrombin injection and in a difficult location for open repair.

Axillary compared to brachial access for endovascular procedures.

OBJECTIVES: Limited knowledge exists regarding access site complication rates between trans-axillary and trans-brachial approaches with sheath sizes ≥6Fr. We retrospectively reviewed our institution experience with access site complications for percutaneous trans-axillary and trans-brachial arterial interventions using sheath sizes ranging from 6Fr to 10Fr. METHODS: We examined 67 endovascular interventions performed over 18 months, restricted to sheath sizes of 6Fr to 10Fr. Procedures utilizing trans-brachial (41 cases) and trans-axillary (26 cases) approaches under sonographic guidance were included. Cases involving hemodialysis accesses and those requiring surgical cut-down were excluded. The primary outcome measure was the occurrence of major access site complications (SIR grade-II/III) within 30 days, with data collected on hemostasis method, sheath size, and complications. Statistical analysis involved ANCOVA and Fisher's exact tests, with significance set at p < .05. RESULTS: Successful percutaneous arterial access was achieved in all cases using either approach (trans-axillary or trans-brachial). Closure devices were employed in all axillary punctures and in 71% of brachial punctures. Major access site complications occurred in 7 out of 41 cases (17%) in the trans-brachial group and in 4 out of 26 cases (15%) in the trans-axillary group. However, there was no statistically significant difference in complication rates between the two groups, regardless of access site or sheath size. CONCLUSION: Trans-axillary access serves as a safe and effective upper limb access method for percutaneous endovascular procedures requiring sheath size of 7Fr or larger when compared to trans-brachial approach.

A Novel Suture-Based Vascular Closure Device to Achieve Hemostasis after Venous or Arterial Access While Leaving Nothing behind: A Review of the Technological Assessment and Early Clinical Outcomes.

Vascular hemostasis after venous and arterial access in cardiovascular procedures remains a challenge. As sheath size gets larger for structural heart and vascular procedures, no dedicated closure devices exist that can overcome all the challenges of achieving vascular hemostasis, in particular on the venous side. Efficiently and reliably ensuring hemostasis at the access point is crucial for enhancing the safety of a procedure. Historically, hemostasis relied on manually compressing venous access sites. However, the shift towards larger sheaths and the more frequent use of continuous anticoagulation has strained this approach. Achieving hemostasis solely through compression in these scenarios demands heightened vigilance and prolonged application, resulting in increased patient discomfort and extended immobility. Consequently, manual compression may consume more time for healthcare providers and contribute to bed occupancy in hospitals. This review article summarizes the development of the SiteSeal® Vascular Closure Device, a novel leave-nothing-behind approach to achieve hemostasis. The introduction of this technology has provided clinicians with a safer and more effective way to achieve immediate hemostasis, facilitate early ambulation, and enable earlier discharges with fewer access site complications compared with traditional manual compression.

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

INTRODUCTION: 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. OBJECTIVES: We evaluate postprocedural hemostasis and vascular closure outcomes after using LockeT following cardiac electrophysiologic procedures. METHODS: We performed a single-center, observational study of patients who underwent vascular closure for electrophysiology procedures using LockeT. Postprocedural outcomes were subsequently analyzed. RESULTS: 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 h and 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. CONCLUSION: The LockeT can effectively close venous access sites with no major complications.

Incidence and predictors of vascular complications following transcatheter aortic valve implantation: A comparison of the MANTA and suture-based vascular closure devices.

BACKGROUND: Vascular complications post-transcatheter aortic valve implantation (TAVI) are common. Recent data regarding predictors of vascular complications are limited, particularly comparing newer plug-based devices versus traditional suture-based vascular closure devices (VCD). AIM: The primary objective was to identify characteristics that predict a higher risk of vascular complications in TAVI patients, as judged by the VARC-3 criteria, specifically comparing risk factors between suture-based vs MANTA device closure. METHODS: Retrospective analysis of patients who underwent TAVI between December 2019 and September 2023 was performed. Logistic regression and propensity score matching was performed to ascertain risk factors for vascular complications post-TAVI. RESULTS: Of the 1763 patients, there were 106 vascular complications (6%). There was a nonsignificant increased complication rate in MANTA vs suture-based device closure (8.3% vs 5.3%, p = 0.064). Among these, the most common complications were VCD failure (23%), pseudoaneurysm (20%) and arterial dissection (19%). Obesity (p = 0.021), anemia (p = 0.039) and MANTA device use (p = 0.027) were predictors of vascular complications. Within the MANTA cohort, novel oral anticoagulant (NOAC) use was predictive of vascular complications (p = 0.002). Among suture-based devices, obesity (p = 0.037) and anaemia (p = 0.017) were significant predictors. A propensity matched analysis derived 90 pairs of patients matched for age, gender, diabetes, peripheral arterial disease, NOAC use, anemia and obesity, identifying an average treatment effect of 0.039 (p = 0.04) when MANTA device closure was performed. CONCLUSION: Vascular complications in TAVI remain common. Identifying predictors such as MANTA device closure, obesity, anemia, and baseline NOAC use will allow for improved risk stratification and appropriate VCD selection in patients undergoing TAVI.

SURgical vs. PERcutaneous ACCESS in Transfemoral Transcatheter Aortic Valve Implantation (SU-PER-ACCESS Study).

Background: The transfemoral (TF) approach is the most common route in TAVI, but it is still associated with a risk of bleeding and vascular complications. The aim of this study was to compare the clinical outcomes between surgical cut-down (SC) and percutaneous (PC) approach. (2) Methods: Between January 2018 and June 2022, 774 patients underwent a transfemoral TAVI procedure. After propensity matching, 323 patients underwent TAVI in each group. (3) Results: In the matched population, 15 patients (4.6%) in the SC group vs. 34 patients in the PC group (11%) experienced minor vascular complications (p = 0.02), while no difference for major vascular complication (1.5% vs. 1.9%) were reported. The rate of minor bleeding events was higher in the percutaneous group (11% vs. 3.1%, p <.001). The SC group experienced a higher rate of non-vascular-related access complications (minor 8% vs. 1.2%; major 2.2% vs. 1.2%; p < 0.001). (4) Conclusions: SC for TF-TAVI did not alter the mortality rate at 30 days and was associated with reduced minor vascular complication and bleeding. PC showed a lower rate of non-vascular-related access complications and a lower length of stay. The specific approach should be tailored to the patient's clinical characteristics.

Same-day discharge after percutaneous closure of persistent foramen ovale using intracardiac echocardiography and the Gore Septal Occluder.

Aim: Periprocedural and postinterventional care of patients undergoing closure of patent foramen ovale (PFO) varies significantly across care providers. Same-day discharge (SDD) after transcatheter interventions is an evolving concept. This study aimed to assess the same-day discharge rate and incidence of complications in patients undergoing PFO closure with intracardiac echocardiography (ICE) using the Gore®Cardioform Septal Occluder (GSO) device. The secondary aim was to analyse the efficacy of femoral vein closure with Perclose ProGlide. Methods: Patients who underwent PFO closure with the GSO device at a university hospital in Stockholm, Sweden, were retrospectively included between March 1, 2017, and June 30, 2020, all with cryptogenic stroke as the indication for the procedure. All patients underwent PFO closure with conscious sedation and local anaesthesia. The indication for all patients was a cryptogenic stroke. Periprocedural imaging was performed using ICE and fluoroscopy in all patients. Patient characteristics and periprocedural data were collected from patient charts. Patients were kept on bed rest for 4-6 h post-intervention. Transthoracic echocardiography and clinical examination, including groin status, were performed before discharge. No clinical routine follow-up was performed the day following the intervention. Clinical follow-up was done by phone call two weeks after the procedure, and echocardiographic follow-up was done after 12 months. Data were analysed using linear and logistic regression models. Results: In total, 262 patients were included, of which 246 (94%) had SDD. 166 patients (63%) received the ProGlide™ system for femoral vein access closure. Post-procedural arrhythmias occurred in 17 (6%) patients, and vascular complications in 9 patients (3%). The overall closure rate at follow-up was 98.5%. 25 out of 264 patients (9.5%) had to be readmitted within the first eight weeks after PFO closure, 16 due to atrial fibrillation warranting electric cardioversion, one due to an arteriovenous fistula that was operated, four due to chest pain/pain at the access site, and four patients developed fever. There was no difference in SDD among patients who received ProGlide™ vs. patients who did not receive ProGlide™. Conclusion: SDD appears safe after transcatheter PFO closure with the GSO device with high procedural success rates. Low rates of complications and readmissions make the intervention suitable for this patient-friendly and cost-effective concept.

Importance of pseudoaneurysms after TAVI - a retrospective analysis of 2063 patients.

Background: Bifemoral arterial access is common in patients undergoing transcatheter aortic valve implantation (TAVI), with a primary treatment access (TAVI access) and a secondary non-TAVI access. Pseudoaneurysm (PSA) is an important complication of femoral arterial puncture. Major vascular complications after TAVI are well described, but little is known about PSA. Patients and methods: A total of 2063 patients underwent transfemoral TAVI between January 2014 and January 2020. Vascular ultrasound of the common femoral artery was assessed before and after TAVI. We compared patient characteristics, periprocedural risk scores, procedural characteristics, and access site bleeding events according to Valve Academic Research Consortium 3 (VARC-3) criteria, length of stay (LOS), and all-cause mortality at one year between patients with (46) and without (2017) PSA. Results: The incidence of PSA after TAVI was 2.2% (46/2063). All PSA were successfully treated with ultrasound-guided manual compression (UGMC) or thrombin injection (UGTI) without complications. Patients with PSA had lower platelet counts (210×1000/µl vs. 234×1000/µl; p<0.05), more heart failure symptoms on admission (91% vs. 25%; p<0.05), were more often treated with (N)OACs for atrial fibrillation (AF; 54% vs. 38%; p <0.05), and were less often treated with aspirin (35% vs. 51%; p<0.03). Multivariate analysis identified secondary access site (odds ratio [OR] 8.11; p<0.001) and (N)OAC therapy (OR 1.31; p = 0.037) as risk factors for PSA development. PSA is associated with VARC-3 type 1-3 access site bleeding and longer LOS (15.2 ± 11.3 d vs. 11.6 ± 8.9 d; p<0.01), but this did not affect one year mortality (17% vs. 14%; p = 0.53). Conclusions: Pseudoaneurysms are an important complication after TAVI and are associated with access site bleeding and prolonged hospital stay. (N)OAC therapy and secondary access are important risk factors. Pseudoaneurysms can be safely and effectively treated with thrombin injection and do not affect one-year mortality.