Search Results (47)

Background and Objectives: Patients with severe aortic stenosis (AS) frequently present with concomitant peripheral artery disease (PAD), which complicates transcatheter aortic valve implantation (TAVI) and increases the risk of vascular complications. Early identification of significant PAD may facilitate optimized procedural planning and risk stratification. This study aimed to develop and internally validate a clinical score for estimating the likelihood of significant PAD in patients with severe AS undergoing TAVI evaluation and to exploratorily assess its association with femoral access-site closure-device failure after TAVI. Materials and Methods: In this retrospective study, 138 patients with severe AS (124 undergoing TAVI) were evaluated. Logistic regression analyses identified independent predictors of significant PAD (≥50% stenosis), which were incorporated into the AS-PAD Score. The Score integrates age >75 years, diabetes mellitus, BMI ≥25 kg/m², Lp(a) >50 mg/dL (105 nmol/L), and Fontaine clinical stage. Model performance was assessed using receiver operating characteristic (ROC) analysis and internally validated using bootstrap resampling and stratified five-fold cross-validation. Vascular complications were adjudicated according to VARC-3 criteria. Results: The AS-PAD Score demonstrated good discriminatory performance, with an AUROC of 0.804. Advanced age (OR 2.43, 95% CI:1.05–5.70; p = 0.039) and diabetes (OR 3.18, 95% CI:1.29–7.83; p = 0.012) were independently associated with significant PAD, while BMI ≥25 kg/m² showed an inverse association. Elevated Lp(a) (>50 mg/dL) remained independently associated with significant PAD. Internal validation using bootstrap resampling and stratified five-fold cross-validation demonstrated consistent model performance. Femoral access-site closure-device failure occurred more frequently among patients classified as intermediate or high risk by the AS-PAD Score compared with low-risk patients. Conclusions: The AS-PAD Score may serve as an adjunctive clinical tool for estimating the likelihood of significant PAD in patients with severe AS undergoing TAVI evaluation. Its association with femoral access-site closure-device failure should be interpreted as exploratory and hypothesis-generating. Further external validation is required to confirm its role alongside standard CT-based vascular assessment. Full article

Background: Venous closure devices (VCDs) are being increasingly used after femoral venous access to facilitate recovery, but their comparative efficacy and safety versus manual compression or figure-of-eight suture remain uncertain. Because femoral venous access management is influenced by patient-related and procedural factors, VCDs may contribute to a more personalized postprocedural recovery strategy. Objective: Evaluation of the impact of VCDs on procedural recovery and vascular complications in patients undergoing cardiac procedures via femoral venous access. Methods: We systematically searched PubMed, Embase, and CENTRAL through to April 2025 for randomized controlled trials (RCTs) comparing VCDs with manual compression and/or figure-of-eight suture. Primary efficacy outcomes were time to hemostasis (TTH), time to ambulation (TTA), time to discharge (TTD), and time to discharge eligibility (TTDe). Safety outcomes were major and minor vascular complications. Risk of bias was assessed with RoB 2, and certainty of evidence assessed with GRADE. Random-effects models were used to pool standardized mean differences (SMDs) or risk ratios (RRs) with 95% confidence intervals (CIs). Results: Seven RCTs (n = 948) were included. VCDs use significantly reduced TTH (SMD: −1.00; 95% CI: −1.57 to −0.42) and TTA (SMD: −1.50; 95% CI: −2.42 to −0.58). TTD showed a non-significant trend favoring VCDs (SMD: −0.99; 95% CI: −2.13 to 0.15), while TTDe was consistently shorter with VCDs across three trials. Major vascular complications were rare and similar between groups (RR: 0.41; 95% CI: 0.09–1.89). Minor vascular complications were significantly reduced with VCDs (RR: 0.42; 95% CI: 0.22–0.79). Conclusions: In patients requiring femoral venous access for interventional cardiology procedures, VCDs improve time to hemostasis and ambulation and reduce minor vascular complications without increasing major events. These findings support VCDs as an effective and safe strategy for venous closure. Full article

Background: Femoral arteriotomy closure after peripheral angiography and intervention is commonly achieved using vascular closure devices (VCDs) or compression-based strategies; however, comparative randomised data in contemporary peripheral endovascular practice remain limited. Methods: In this prospective randomised trial, adults undergoing femoral-access diagnostic angiography or peripheral endovascular intervention were assigned in a 1:1 ratio to haemostasis with the FemoStop™ II Gold pneumatic compression system or a contemporary VCD strategy. The primary endpoint was a composite of major or minor groin-site complications immediately after sheath removal. Secondary endpoints included composite complications at recovery, discharge, and 30 days, with separate analyses of major and minor complications. Patient-reported pain was assessed using the Verbal Numerical Rating Scale (VNRS). Efficacy and safety analyses were performed according to the intention-to-treat and as-treated principles, respectively. Risk ratios were estimated using modified Poisson regression with robust variance, with prespecified adjustment for sex, systolic blood pressure before sheath removal, and sheath size. Results: A total of 130 participants underwent randomisation, including 66 assigned to FemoStop™ II Gold and 64 assigned to VCDs. The primary composite endpoint occurred in 23/66 participants (34.9%) in the FemoStop™ II Gold group and 16/64 (25.0%) in the VCD group (absolute difference, 9.9 percentage points; 95% confidence interval [CI], −6.1 to 25.7; p = 0.25), with the numerical difference driven predominantly by minor-only events (28.8% versus 15.6%; p = 0.09). At 30 days, the composite endpoint occurred in 17/66 participants (25.8%) and 12/64 participants (18.8%), respectively (absolute difference, 7.0 percentage points; 95% CI, −13.3 to 26.4; p = 0.40). Serious access-site events remained infrequent both immediately post-procedure (6.1% versus 9.4%; p = 0.53) and at 30 days (6.1% versus 4.7%; p = 0.72). The adjusted risk ratios were 1.28 (95% CI, 0.74 to 2.21) for the primary composite endpoint and 1.23 (95% CI, 0.63 to 2.40) for the 30-day composite endpoint. Ordinal VNRS pain distributions did not differ significantly at any timepoint, although “any pain” immediately post-procedure was less frequent with FemoStop™ II Gold (22.7% versus 40.6%; unadjusted risk ratio, 0.56; 95% CI, 0.33 to 0.93); this association was attenuated after adjustment (adjusted risk ratio, 0.63; 95% CI, 0.38 to 1.03). Prespecified interaction testing suggested that the effect of treatment on composite complications varied according to sheath size both immediately post-procedure and at 30 days (p < 0.001 for both interactions). Conclusions: In patients undergoing femoral-access diagnostic angiography or peripheral endovascular intervention, haemostasis with FemoStop™ II Gold resulted in 30-day groin-site complication rates that did not differ significantly from those observed with contemporary VCD strategies. Serious access-site events remained infrequent in both groups, and the apparent early reduction in patient-reported pain with FemoStop™ II Gold was not definitive after adjustment. Larger, adequately powered multicentre studies are warranted to clarify sheath size-dependent effects and uncommon clinically consequential vascular events. Full article

Transcatheter aortic valve implantation (TAVI) has become the standard of care for patients with severe aortic stenosis. Despite significant procedural refinement, vascular complications (VCs) remain among the most frequent and clinically relevant adverse events associated with TAVI. These complications are closely associated with adverse clinical outcomes and continue to represent one of the most significant limiting factors for the broader expansion of TAVI indications to larger patient populations. Over the past decade, their incidence has declined substantially, largely due to device evolution, improved closure techniques, and the widespread adoption of meticulous pre-procedural imaging and planning. This narrative review provides a comprehensive overview of VCs in TAVI, focusing on contemporary incidence rates, underlying mechanisms, and patient as well as procedural-related risk factors. Additionally, the role of alternative access routes is discussed, alongside emerging technologies and future perspectives aimed at further reducing complication rates. Full article

Background/Objectives: Plug-based vascular closure devices (Pb-VCDs) are routinely used in 14 and 18 French (F) size for percutaneous vascular access site closure during transfemoral transcatheter aortic valve replacement (TAVR). Recently, larger 18F Pb-VCDs were linked to increased incidence of vascular complications in randomized comparisons. Smaller 14F devices are hypothesized to decrease the incidence of vascular complications, but real-world data on their safety in routine clinical practice is scarce. Methods: We performed a retrospective, propensity score-matched comparison of patients receiving either 14F or 18F Pb-VCDs during TAVR from March 2019 to December 2020. The choice of 14F or 18F Pb-VCD utilization depended on the sheath size during the procedure. No other vascular closure systems (VCDs) were used despite the MANTA (Teleflex Inc.^®, Morrisville, NC, USA) Pb-VCD. The primary endpoints were major and minor vascular complications defined by valve academic research consortium-3 (VARC 3) criteria. Secondary endpoints included VARC-3 bleeding events, length of hospital stay and in-hospital mortality. Results: A total of 183 (14F Pb-VCD) and 110 (18F Pb-VCD) patients were included in 1:1 propensity score matching and resulted in 85 matched patient pairs. The primary endpoint of major and minor vascular complications was balanced between the groups (major: 3.5% (14F Pb-VCD) versus (vs.) 0.0% (18F Pb-VCD), p = 0.25; minor: 12.9% vs. 14.1, p = 1.00). Secondary endpoints of VARC-3 bleeding events (p = 1.00), length of hospital stay (p = 0.34), and in-hospital mortality (p = 1.00) were equally distributed. Conclusions: There is no difference in major and minor VARC-3-defined vascular complications between the 14F and 18F groups in our study. Following this real-world observational analysis, observed rates of vascular complications need to be validated in prospective controlled trials. Full article

Background: Femoral cannulation is essential for minimally invasive mitral valve surgery (MIMVS). Our center transitioned from open femoral cut-down to ultrasound-guided percutaneous cannulation supported by smart venous cannulas, ThruPort arterial access, and the MANTA closure device. This study evaluates how this transition affects procedural efficiency, vascular safety, and postoperative outcomes. Methods: We retrospectively analyzed 575 consecutive MIMVS patients (2014–2025). Patients treated before 2021 formed the cut-down group, while those from 2021 onward underwent percutaneous cannulation. The outcomes included operative times, groin and lymphatic complications, MANTA performance, and 30-day mortality. Propensity score matching (PSM) was performed to adjust for baseline differences. Results: Of 575 patients, 393 (68.3%) underwent cut-down and 182 (31.7%) percutaneous access. Percutaneous access was associated with shorter cardiopulmonary bypass times (115 vs. 128 min, p < 0.0001), total operative times (210 vs. 242 min, p < 0.0001), ICU stays (2 vs. 3 days, p = 0.0267), and hospital stays (8 vs. 11 days, p < 0.0001). Lymph fistula occurred in 4.3% of cut-down cases and in 0% after the adoption of percutaneous access (p = 0.0004). Overall groin complication rates were comparable (2.8% vs. 4.9%, p = 0.51). MANTA closure had a 2.2% device-related complication rate (1.1% bleeding; 1.1% ischemia) with no documented long-term sequelae. Regarding 30-day mortality, this was 4.6% in the cut-down group and 1.6% in the percutaneous group (p = 0.096). In PSM (72 matched pairs), percutaneous access retained significantly shorter operative, bypass, and ICU times, with identical groin complication rates. Conclusions: Ultrasound-guided percutaneous femoral cannulation was associated with improved procedural efficiency and elimination of lymphatic morbidity, without increasing vascular risk or mortality. It represented a safe and effective standard strategy for contemporary MIMVS. Full article

Paravalvular leak (PVL) remains a clinically important complication after surgical or transcatheter valve implantation, presenting predominantly with heart failure (HF) and/or high-shear hemolysis. While redo surgery can be definitive, contemporary candidates frequently carry prohibitive operative risk, positioning transcatheter PVL closure as a key therapeutic alternative. However, available outcome data are largely derived from observational series and registries with heterogeneity in PVL mechanisms, prosthesis types, imaging protocols, and endpoint definitions. Standardized frameworks—such as those proposed by the PVL Academic Research Consortium—support harmonized PVL grading and clinically meaningful composite endpoints that integrate imaging/hemodynamic results with patient-centered outcomes. Across datasets, the most consistent determinant of benefit is residual PVL severity: procedural efficacy is most commonly defined as achieving ≤ mild residual regurgitation without prosthetic leaflet interference, device embolization, or major complications. This review provides a step-by-step, phenotype-driven approach to transcatheter PVL closure, emphasizing multimodality imaging (TEE and cardiac CT, with adjunct CMR and PET when appropriate), access and support planning tailored to valve position, and morphology-matched device selection—often requiring modular multi-device strategies for elongated crescentic channels, particularly in hemolysis-predominant presentations. We also synthesize evidence on complications and bailout management, with a focus on preventable high-severity events (leaflet impingement, embolization, stroke/air, vascular injury, tamponade) and standardized pre-release safety checks. Collectively, contemporary practice supports high implant success in experienced programs, with clinical improvement tightly coupled to procedural endpoint quality and careful Heart Team selection. Full article

Background: Inadvertent arterial cannulation during central venous catheter placement is a recognized complication with potentially serious consequences, particularly when involving large-caliber catheters. While management strategies have evolved from mandatory surgical repair to various percutaneous approaches, limited data exist regarding collagen-based vascular closure devices for large-bore carotid arteriotomies. Case Presentation: We report the case of a 59-year-old male patient with acute Stanford Type A aortic dissection who underwent emergency surgical repair of the ascending aorta. During central venous cannulation, a five-lumen Certofix Quinto catheter (12-French outer diameter) was inadvertently inserted into the left common carotid artery. Given the complexity of concurrent cardiac surgery and the large-bore nature of the arteriotomy, percutaneous closure with an 18-French MANTA vascular closure device was successfully performed following completion of the aortic repair. The procedure achieved immediate hemostasis without complications. Outcomes: The patient remained neurologically intact throughout a 12-month follow-up period. Serial duplex ultrasonography and computed tomography angiography confirmed carotid artery patency without evidence of stenosis, dissection, pseudoaneurysm formation, or thromboembolic complications. Conclusions: This case demonstrates the technical feasibility of using a collagen-based vascular closure device for percutaneous management of a large-bore carotid arteriotomy in the acute surgical setting. While the outcome was favorable in this patient, this approach represents an off-label application that requires further validation and should be reserved for carefully selected cases in experienced centers where the benefits of percutaneous closure are judged to outweigh the uncertainties of supra-aortic device deployment. Full article

Background and Objectives: Access-site complications (ASCs) remain clinically relevant after peripheral endovascular procedures, particularly with large femoral sheaths and complex anatomy. While randomized coronary trials show non-inferiority of vascular closure devices (VCDs) versus manual compression (MC), real-world data in peripheral interventions performed under systematic ultrasound-guided access are limited. Materials and Methods: This retrospective single-center cohort included consecutive peripheral arterial revascularizations (2010–2023) performed via common femoral access under real-time ultrasound guidance. Hemostasis was achieved using MC or VCDs, categorized as collagen plug-based, suture-mediated, or clip-based systems. The primary endpoint was 30-day ASCs, defined as hematoma requiring management, pseudoaneurysm, bleeding requiring transfusion, access-site thrombosis/occlusion, arteriovenous fistula, or infection. The secondary endpoint was VCD failure, defined as unsuccessful hemostasis requiring adjunctive measures. Multivariable logistic regression adjusted for prespecified anatomical and procedural covariates, including sheath size > 6 Fr and puncture-site calcification. Results: Among 231 procedures, VCDs were used in 139 (60.2%) and MC in 92 (39.8%). ASC occurred in 28 cases (12.1%), with higher rates in the MC group compared with VCDs (18.5% vs. 9–14% across device types; p = 0.044). In adjusted analyses, MC (vs any VCD) (odds ratio [OR] 2.41, 95% confidence interval [CI] 1.06–5.47; p = 0.035), sheath size > 6 Fr, and puncture-site calcification were independently associated with ASCs. VCD failure occurred in 5 cases (3.6%) and was not observed with collagen plug-based devices. Conclusions: In this ultrasound-guided real-world peripheral cohort, VCD use was associated with lower 30-day ASC rates and low device failure rates compared with MC. Given the retrospective and non-randomized design, these findings should be considered hypothesis-generating and support individualized, imaging-guided strategies for femoral closure in peripheral interventions. Full article

Background/Objectives: Emergency arterial embolization is a life-saving procedure typically performed via femoral access. This study evaluated the safety and efficacy of immediate femoral sheath removal following emergency embolization. Methods: A retrospective cohort study was conducted at a Level 1 trauma center (January 2022–May 2025). Adult patients undergoing emergency embolization with immediate sheath removal were included. Endpoints were reintervention (repeat embolization within 7 days) and access site complications. Multivariate logistic regression identified independent predictors of outcomes. Results: A total of 322 emergency embolization procedures in 299 patients were included. The most common indication was gastrointestinal hemorrhage (45.7%). Vascular closure devices (VCDs) were used in 92.5% of cases. The re-intervention rate was 4.0% (13/322). The overall access site complication rate was 6.2% (20/322), with a major complication rate of 0.9% (3/322). On univariate analysis, pre-procedural platelet level ≤ 80 × 10⁹/L (p = 0.034) and INR > 1.5 (p = 0.034) were significantly associated with an increased risk of complications. On multivariate analysis, pre-procedural platelets ≤ 80 × 10⁹/L was the strongest independent predictor of access site complications (OR 7.28, 95% CI 1.51–35.12; p = 0.013). Choice of vascular closure device was an independent predictor for both reintervention and complications (p < 0.05), likely reflecting bias. Conclusions: Immediate femoral sheath removal following emergency embolization is safe for most patients. However, thrombocytopenia is a significant risk factor for access site complications. A risk-stratified approach with consideration for delayed sheath removal is warranted for patients with platelet counts ≤ 80 × 10⁹/L. Full article

Background: Vascular closure of the femoral artery during transcatheter aortic valve implantation (TAVI) remains a critical step prone to complications, despite advancements in introducer technology. The traditional technique involves using two ProGlide^® suture closure devices (2P), but alternative approaches, such as employing a single ProGlide^® device (1P), have emerged. Aims: We sought to evaluate the efficacy and safety of the 1P strategy compared to the standard 2P closure technique during transfemoral TAVI procedures. Methods: A registry-based study was conducted at the University Hospitals of Strasbourg, France, from January 2020 to December 2023. Consecutive patients who underwent TAVI via the transfemoral approach were deemed eligible. Results: The study cohort consisted of 1303 patients, with a mean age of 81.7 years and 47% female. The 1P strategy was used in 733 cases (56.3%), while the 2P technique was employed in 570 patients (43.7%). Hemostasis was achieved in the catheterization laboratory without additional devices in 30.4% of the single-ProGlide^® pre-closing cases. Vascular complication rates were similar in both groups, at 11.3% for the 1P technique and 11.4% for the 2P technique (p = 0.964). However, vascular closure device failure was significantly less frequent in the 1P group (1.6%) compared to the 2P group (5.3%). Conclusions: The 1P strategy for pre-closing during TAVI is as effective and safe as the conventional 2P approach. The 1P method offers potential advantages in terms of simplicity and cost-effectiveness. Full article

Background: Left atrial appendage occlusion (LAAO) is a valuable alternative to long-term anticoagulation in patients with atrial fibrillation (AF) and a high bleeding risk. However, effective vascular closure following large-bore venous access remains a clinical challenge, particularly in patients with multiple comorbidities. This study compares two venous closure techniques—Z-sutures and the suture-mediated ProGlide™ device—regarding their safety and efficacy in patients undergoing LAAO. Methods: We conducted a single-center observational study including 163 patients treated with LAAO between 2021 and 2024. Closure was achieved via a Z-suture (n = 126) or the ProGlide™ (n = 37) based on operator preference. The primary endpoint was clinically relevant bleeding (BARC ≥ 2). The secondary endpoints included 30-day mortality and hospital stay duration. Results: The Z-suture group included older and more comorbid patients. Despite these differences, the bleeding rates were comparable between groups. Clinically relevant bleeding was infrequent (Z-suture: 12.6%; ProGlide™: 13.5%). No 30-day deaths occurred in either group, and their hospital stay durations were similar. Conclusions: Both the Z-suture and ProGlide™ techniques demonstrated comparable safety and efficacy. Due to their simplicity and potential cost advantage, Z-sutures may be a practical alternative in routine care for high-risk patients. Full article

Transseptal puncture (TSP) is an essential step for left heart procedures that allows access to the left atrium (LA) through the fossa ovalis (FO) of the interatrial septum (IS). Initially developed for diagnostic purposes, today, it is performed for procedures that require large-bore device delivery systems and complex three-dimensional navigation in the left atrium. TSP supports various interventions, including atrial fibrillation ablation, left atrial appendage closure, and transcatheter mitral valve repair and replacement. While traditionally performed with Brockenbrough needles under fluoroscopic guidance, the integration of transesophageal and intracardiac echocardiography (TEE/ICE) has significantly improved its safety and precision. Despite its generally high success rate, TSP poses challenges in complex anatomies or for less experienced operators, with complications such as cardiac tamponade, aortic root puncture, and embolic events. Anatomical variations, such as thickened or floppy septa, further complicate the procedure. Technological advancements, including radiofrequency-based systems and specialized guidewires, have enhanced safety in difficult cases. Effective training, including echocardiography and complication management, is vital for operator proficiency. This review outlines the procedural steps for safe TSP, emphasizing proper equipment selection, anatomical considerations, and vascular access techniques. Common complications are discussed alongside management strategies. Advanced tools and techniques for addressing challenging scenarios are highlighted. Full article

Purpose: This study aimed to evaluate the efficacy and safety of the Angio-Seal™ VIP vascular closure device (VCD) in achieving hemostasis following percutaneous transhepatic portal venous interventions. Methods: This retrospective study evaluated 20 patients (mean age: 52.85 ± 16.18 years; 80% male) who underwent percutaneous transhepatic portal vein interventions followed by tract closure with the Angio-Seal™ device between January 2016 and September 2024. Procedural data, pre- and post-procedural hemoglobin and hematocrit levels, and complications were analyzed. Technical success was defined as the successful deployment of the device with immediate hemostasis and no evidence of bleeding on post-procedural imaging. Results: Technical success, as defined in this study, was achieved in all 20 procedures (100%). The mean hemoglobin level declined from 11.91 ± 2.01 g/dL to 11.09 ± 2.19 g/dL (p < 0.001), and the mean hematocrit level decreased from 36.18 ± 6.03% to 32.98 ± 5.80% (p = 0.001). A hemoglobin drop ≥2 g/dL occurred in two patients (10%) and a hematocrit drop ≥4% in six patients (30%); none were associated with imaging or clinical evidence of hemorrhage. No major complications were observed. Minor complications, including localized pain managed with analgesics, occurred in five patients (25%). Follow-up imaging confirmed the absence of hemoperitoneum or device-related failure. Conclusions: Angio-Seal™ is a technically feasible, safe, and effective option for tract closure following percutaneous transhepatic portal vein access. This single-device approach may offer a cost-effective alternative to traditional embolization techniques. However, more extensive prospective studies are required to validate these findings. Full article

Background: The accidental puncture of the supra-aortal arteries during central venous catheterization is a rare but potentially life-threatening complication. Traditional management often requires open surgical repair, which is associated with significant morbidity. This study evaluates an endovascular approach for managing such cases using an Angio-Seal™ vascular closure device (Terumo Medical Corporation, Somerset, NJ, USA). Methods: Between January 2010 and December 2024, 47 patients with misplaced catheters in supra-aortal arteries were treated at our institution. Of these, 37 cases involving subclavian artery catheter misplacements were managed using a standardized algorithm and form the focus of this study. Additional interventions, such as stent graft placement or balloon inflation, were performed as needed. Results: Primary technical success was achieved in 86.5% of cases. Four patients required stentgrafts and one balloon inflation for persistent extravasations. One patient developed a small subclavian pseudoaneurysm, which resolved spontaneously. Primary assisted technical success and clinical success rates were both 100%. Conclusions: This study demonstrates the efficacy and safety of our minimally invasive endovascular approach for managing subclavian artery catheter misplacements. With a high success rate, low complication rate, and the avoidance of open surgery, this algorithm offers a promising alternative for treating this rare but serious complication of central venous catheterization. Full article