Arterial Access Closure Research Articles

A systematic algorithm for large-bore arterial access closure after TAVI: the TAVI-MultiCLOSE study.

Despite transcatheter aortic valve implantation (TAVI) having become a routine procedure, access site bleeding and vascular complications are still a concern which contribute to procedure-related morbidity and mortality. The TAVI-MultiCLOSE study aimed to assess the safety and efficacy of a new vascular closure algorithm for percutaneous large-bore arterial access closure following transfemoral (TF)-TAVI. All consecutive TF-TAVI cases in which the MultiCLOSE vascular closure algorithm was used were prospectively included in a multicentre, observational study. This stepwise algorithm entails the reinsertion of a 6-8 Fr sheath (primary access) following the initial preclosure with one or two suture-based vascular closure devices (VCDs). This provides the operator with the opportunity to perform a quick and easy angiographic control and tailor the final vascular closure with either an additional suture- or plug-based VCD, or neither of these. Among 630 patients who underwent TF-TAVI utilising the MultiCLOSE algorithm, complete arterial haemostasis was achieved in 616 patients (98%). VCD failure occurred in 14 patients (2%), treated with either balloon inflation (N=1), covered stent (N=12) or surgical repair (N=1). Overall, this vascular closure approach resulted in a minor and major vascular complication rate of 2.2% and 0.6%, respectively. At 30 days, only one new minor vascular complication (0.2%) was noted. In-hospital and 30-day all-cause mortality rates were 0.2% and 1.0%, respectively. Use of the MultiCLOSE vascular closure algorithm was demonstrated to contribute to an easy, safe, efficacious and durable vascular closure after TF-TAVI, resulting in a major vascular complication rate of less than 1%.

Systematic review and meta-analysis comparing Manta device and Perclose device for closure of large bore arterial access.

Data comparing MANTA device with Perclose device for large bore arterial access closure is limited. We performed meta-analysis to compare safety and efficacy of the two devices in large (⩾14 Fr sheath) arteriotomy closure post-TAVR. Relevant studies were identified via PubMed, Cochrane, and EMBASE databases until June, 2022. Data was analyzed using random effect model to calculate relative odds of VARC-2 defined access-site complications and short-term (in-hospital or 30-day) mortality. A total of 12 studies (2 RCT and 10 observational studies) comprising 2339 patients were included. The odds of major vascular complications (OR 0.99, 95% CI 0.51-1.92; p = 0.98); life threatening and major bleeding (OR 0.77, 95% CI 0.45-1.33; p = 0.35); minor vascular complications (OR 1.37, 95% CI 0.63-2.99; p = 0.43); minor bleeding (OR 0.94, 95% CI 0.57-1.56; p = 0.82); device failure (OR 0.74, 95% CI 0.49-1.11; p = 0.14); hematoma formation (OR 0.76, 95% CI 0.33-1.75; p = 0.52); dissection, stenosis, occlusion, or pseudoaneurysm (OR 1.08, 95% CI 0.71-1.62; p = 0.73) and short-term mortality (OR 1.01, 95% CI 0.55-1.84; p = 0.98) between both devices were similar. MANTA device has a similar efficacy and safety profile compared to Perclose device.

MANTA vascular closure device bleeding and vascular complications in association with cardiovascular risk factors: a large single centre experience

Abstract Background Percutaneous cardiovascular interventions such as transcatheter aortic valve replacement (TAVR), balloon aortic valvuloplasty (BAV), and mechanical circulatory support (MCS) involve large-bore arterial cannulation. Clinically significant bleeding and vascular complications are frequently encountered as a consequence of arterial cannulation. Collagen-based vascular closure devices (VCD) such as MANTA VCD are increasingly utilized to achieve arterial vascular access closure. This study aims to explore the association between cardiovascular risk factors and bleeding and vascular complications in procedures utilizing MANTA VCD. Methods A large single-centre retrospective study was performed of patients who underwent TAVR, BAV, and MCS in which arterial access closure was achieved with MANTA VCD. All cases from June 2019 to September 2020 were included. The primary efficacy outcome was defined as immediate haemostasis. The secondary safety outcome was defined as Valve Academic Research Consortium-3 (VARC-3) criteria bleeding and vascular complications. Baseline patient characteristics were obtained to evaluate the association between cardiovascular risk factors and outcomes. Results One hundred and seventy-four cases involved vascular access site closure using MANTA VCD. Immediate haemostasis of the access site was achieved in 92.5% of cases (n=161) whereas 7.5% of cases had failed immediate haemostasis (n=13). VARC-3 criteria bleeding and vascular complications occurred in 12.1% of cases (n=21). Cardiovascular risk factors including coronary artery disease and smoking history were associated with an increased risk for bleeding and vascular complications. Rate of bleeding and vascular complications among patients with coronary artery disease (CAD) (n=71) was 18.3% whereas the rate among patients without CAD (n=103) was 7.8%; this association was statistically significant with an odds ratio of 2.66 (95% CI 1.04 – 6.81, p < 0.05). Rate of bleeding and vascular complications among patients with a smoking history (n=67) was 19.4% whereas the rate among patients without a smoking history (n=107) was 7.5%; this association was statistically significant with an odds ratio of 2.98 (95% CI 1.16 – 7.63, p < 0.05). There was no statistically significant difference in the rate of bleeding and vascular complications for other cardiovascular risk factors such as, hypertension, peripheral vascular disease, atrial fibrillation, obesity, diabetes, chronic kidney disease, or chronic obstructive pulmonary disease. Conclusions MANTA VCD is a safe and effective tool for arterial access closure in procedures such as TAVR, BAV, and MCS. CAD and smoking are associated with a higher risk for VARC-3 criteria bleeding and vascular complications. Further multicentre studies are necessary to explore the association of cardiovascular risk factors with vascular access site closure complications and improve outcomes.

Arm-only combined transarterial and transvenous access for neurointerventional procedures: a double-center retrospective study.

This study aims to share our experience with the arm-only combined transarterial and transvenous access approach for neurointerventional procedures and evaluate its efficacy and safety. The arm-only combined transarterial and transvenous access approach was performed using the right/bilateral proximal radial arteries and the right forearm superficial vein system, guided by ultrasonic guidance. Arterial access closure was achieved using a transradial band radial compression device, while manual compression was utilized for venous approach closure. Thirteen procedures were successfully performed using the arm-only combined transarterial and transvenous access approach, yielding favorable outcomes. The procedures included dural arteriovenous fistula embolization (seven cases), cerebral arteriovenous malformation embolization (four cases), venous sinus thrombosis catheter-directed thrombolysis and intravenous thrombectomy (one case), and cerebral venous sinus stenosis manometry (one case). All procedures were uneventful, allowing patients to ambulate on the same day. At discharge, all patients exhibited modified Rankin scores of 0-2, without any access site or perioperative complications. This double-center study preliminarily demonstrates the feasibility and safety of arm-only combined transarterial and transvenous access applied in neurointerventional procedures for complicated cerebrovascular diseases. The proximal radial artery and forearm superficial vein are recommended as the primary access sites. Unobstructed compression is strongly recommended for radial approach closure. This study aimed to add evidence and experience on the arm-only combined transarterial and transvenous access, as a new approach, for neurointerventional treatment that required arteriovenous approaches.

Comparison of percutaneous closure systems for large bore vascular access sites in endovascular procedures.

The vascular closure device (VCD) is a medical device used for achieving hemostasis of vascular access sites greater than 8 Fr. We compared complications after placement of Perclose ProGlide (Abbott Vascular, USA), a percutaneous suture-mediated closure system, with MANTA VCD (Teleflex Vascular, USA), a collagen-based closure device. This retrospective cohort study analyzed procedures performed between 2016 and 2021. We compared the incidence of bleeding complications according to the Bleeding Academic Research Consortium (BARC) and Valve Academic Research Consortium-3 (VARC-3) criteria. The comparison was made between two cohorts of patients: in the first, vascular access sites were closed with a double Perclose ProGlide system, and in the second with an 18 Fr MANTA VCD. A total of 189 patients were included in the study, out of which 63% were male and 37% were female, with a median age of 79 (72-83) years. All devices were used for femoral arterial access closure. A double Perclose ProGlide was used in 91 (48%) patients, while MANTA VCD was used in 98 patients (52%). The distribution of patients by VARC-3 and BARC bleeding criteria differs between groups (p = 0.017). A significantly higher incidence of VARC 1 (14% vs. 4%; p = 0.020) and BARC 1-2 (14% vs. 4%; p = 0.020) complications in the Perclose ProGlide cohort was observed. VARC 3 (1% vs. 5%; p = 0.213) and BARC 3b (1% vs. 5%; p = 0.213) complications showed higher, but statistically non-significant rates of major bleeding complications in the MANTA VCD cohort. The need for subsequent surgical revision did not show a significant difference between the cohorts (2% vs. 6%; p = 0.281). The Perclose ProGlide cohort was associated with a significantly higher rate of milder complications. MANTA VCD cohort had a higher rate of major bleeding complications, requiring more complex treatment with a potentially larger impact on quality of life.

Hybrid method of large bore arterial access closure: Single-center initial experience based on percutaneous coronary artery interventions assisted with left ventricle support device.

Hybrid method of large bore arterial access closure: Single-center initial experience based on percutaneous coronary artery interventions assisted with left ventricle support device.

Single arterial access closure of post-infarction ventricular septal defect: A case series.

Post-infarction ventricular septal defect (PIVSD) carries a very poor prognosis. Surgical repair offers reasonable outcomes in patients who survive the initial healing period. Percutaneous device implantation remains a potentially effective earlier alternative. From March 2018 to May 2022, 11 trans-arterial PIVSD closures were attempted in 9 patients from twocenters (aged 67.2 ± 11.1 years; 77.8% male). Two patients had a second procedure. Myocardial infarction was anterior in four patients (44.5%) and inferior in five cases (55.5%). Devices were successfully implanted in all patients. There were no major immediate procedural complications. Immediate shunt grade postprocedure was significant (11.1%), minimal (77.8%), or none (11.1%). Median length of stay after the procedure was 14.8 days. Five patients (55%) survived to discharge and were followed up for a median of 605 days, during which time no additional patients died. Single arterial access for percutaneous closure of PIVSD is a good option for these extremely high-risk patients, in the era of effective large-bore arterial access closure. Mortality remains high, but patients who survive to discharge do well in the longer term.

The “Pro-Seal” Large-Bore Arterial Access Closure Technique: Making the Best of What Is Available

The number of patients undergoing transcatheter aortic valve replacement (TAVR) and other percutaneous procedures for structural heart disease has risen in recent years and will likely continue to increase. Despite iterative improvements in delivery systems resulting in smaller sizes and entry profiles, large-bore vascular access will continue to be needed. Cardiovascular interventionalists are tasked with performing TAVR procedures as safely as possible while maintaining a low incidence of bleeding and ischemic access site complications—all while using commercially available vascular closure equipment.Multiple large-bore vascular closure devices are currently used in clinical practice; one of the most commonly employed is the suture-based Perclose ProGlide system (Abbott Vascular, Inc). Even though its versatility and effectiveness are acceptable, the Perclose ProGlide device does occasionally fail. How best to achieve complete hemostasis when a failure occurs remains to be determined.In this issue of the Journal, Cakal et al1 report their experience using an ANGIOSEAL device (Terumo Medical Corporation) in patients for whom Perclose ProGlide device deployment did not result in complete hemostasis. The authors performed a retrospective review of 185 patients who underwent TAVR in their center. In all individuals, vascular closure was performed using 2 Perclose ProGlide devices; in 46 of these patients, an 8F ANGIO-SEAL device was added as a “bailout” when the Per-close ProGlide device failed and persistent vascular bleeding was noted. The auxiliary ANGIO-SEAL device was deemed successful in all cases. No statistically significant differences in vascular complications were noted, although a higher incidence of hematoma formation was found in the ANGIO-SEAL bailout group.The findings from Cakal et al1 support the safety and feasibility of using an ANGIO-SEAL device as bailout when use of 2 Perclose ProGlide devices fails to achieve hemostasis in large-bore arterial closure—an approach that has come to be referred to as the “Pro-Seal” technique. These are welcome data because they inform current practice and broaden the operators' options in complex patients. Nonetheless, it is worth noting a particular limitation of this study and its proposed approach (beyond its limited number of patients and retrospective nature). Deciding when hemostasis is suboptimal remains a significantly subjective endeavor. It is unclear whether manual compression after Perclose ProGlide closure might have successfully controlled bleeding in some of these patients, thereby avoiding the use of an additional device that could cause further complications. Clarifying this point is especially important because the operators suggest a Perclose ProGlide failure rate exceeding 20%, which is significantly higher than expected. Fortunately, given the authors' experience, the downside of adding an ANGIO-SEAL device appears to be minimal.Even though a surgeon with experience in open vascular repair may be profoundly dissatisfied with the macroscopic and microscopic appearance of 2 Perclose ProGlide devices and 1 ANGIO-SEAL device in the arteriotomy site, the Pro-Seal technique appears to be an acceptable solution for completing the procedure safely and efficiently. This strategy is effective not only as bailout in case of bleeding but also as a planned strategy from the outset, as demonstrated in a large retrospective study.2 As expected, additional data confirming the utility, safety, and effectiveness of the Pro-Seal approach are needed, as is the development of newer and better closure devices designed from inception to be used specifically for large-bore access closure.

Large-bore arterial access closure after transcatheter aortic valve replacement: a systematic review and network meta-analysis.

AimsAs the indications to transcatheter aortic valve replacement (TAVR) expand to patients at increasingly lower risk, procedure-related vascular and bleeding complications events must be minimized. We aimed to evaluate the impact of different large-bore arterial access closure devices on clinical outcomes after TAVR.Methods and resultsWe searched for papers that reported outcomes according to the type of vascular closure device/technique used after TAVR and performed a Bayesian network meta-analysis (NMA). Fifteen studies involving 9259 patients who underwent access site closure using PROSTAR™ XL percutaneous vascular surgical system (Abbott Vascular, Santa Clara, CA, USA), Perclose ProGlide™ suture-mediated closure system (Abbott), or MANTATM vascular closure device (Teleflex, Morrisville, NC, USA) were included. NMA showed MANTA to have the highest likelihood of reducing a primary composite endpoint of intra-hospital death, major vascular complications, and major or life-threatening bleedings [surface under the cumulative ranking curve analysis (SUCRA) 94.8%], but this was mitigated when only randomized clinical trials and propensity-matched cohorts were included (SUCRA 56.1%). The ProGlide showed the highest likelihood to reduce major or life-threatening bleedings, especially with increasing procedural complexity, and the MANTA device to reduce major and minor vascular complications. The ProStar XL device performed poorly in all explored endpoints.ConclusionAvailable evidence summarized through a NMA shows that ProGlide and MANTA devices appear to be both valid vascular closure devices globally and to be the best options to minimize vascular complications and reduce bleeding in patients undergoing TAVR, respectively.

Alternative Application Technique for the MANTA Vascular Closure Device for Percutaneous Large-Bore Arterial Access Closure: The Fluoroscopic DOT Technique

Background: Vascular complications are a cause of increased morbidity and mortality when performing percutaneous procedures requiring large-bore arterial access. MANTA vascular closure device (VCD) is currently the only large-bore VCD using an intraluminal foot plate and an extraluminal collagen plug. The traditional depth locator approach might be compromised in; emergent cases without the required measurements, cases of hematoma formation, or other patient, procedure, or operator-specific variables. Furthermore, this technique can be used for postclosure in cases without the required measurement of depth. We describe vascular outcomes using fluoroscopy (fluoroscopic DOT technique) rather than traditional depth locator approach for vascular closure with the MANTA VCD. Methods: Fifty patients who underwent transcatheter aortic valve implantation (TAVI) were retrospectively analyzed using fluoroscopic DOT technique with 18F MANTA VCD between May and August 2021. All patients >18 years of age who qualified for transfemoral TAVI were included. Access was obtained with ultrasound guidance with vessel diameter of at least > 6 mm and free from anterior vessel wall calcification. Patient related factors and primary outcomes of access site bleeding and acute flow-limited limb ischemia requiring intervention were prospectively analyzed. Furthermore, 1 patient who failed hemostasis with suture-mediated VCD had successful hemostasis with fluoroscopic DOT technique as dry postclosure after balloon aortic valvuloplasty. Results: In total, 50 patients were analyzed with a mean age of 81 years and majority were male (56%). Majority had comorbidities of hypertension (88%) and hyperlipidemia (94%), 24% had peripheral arterial disease, 38% coronary artery disease, and 58% were former smokers. Importantly, 40% were obese with an average body mass index (BMI) of 29 kg/m2. There were no bleeding or ischemic limb complications post MANTA VCD deployment using the fluoroscopic DOT technique. Furthermore, none of the patients required peripheral intervention from index procedure to 1 month post verified during their 1-month post TAVR follow-up. Conclusion: Fluoroscopic DOT technique using the MANTA VCD is highly reproducible and allows hemostasis in a predictable manner for procedures requiring large-bore arterial access in the absence of MANTA depth measurement.

TCT-283 Large-Bore Arterial Access Closure After Transcatheter Aortic Valve Replacement: A Systematic Review and Network Meta-Analysis

TCT-283 Large-Bore Arterial Access Closure After Transcatheter Aortic Valve Replacement: A Systematic Review and Network Meta-Analysis

Abstract No. 458 Initial review of the Mynx control vascular closure device: comparison with the Vascade vascular closure device

A study analyzing the CathPCI Registry found that the Mynx device was associated with a significantly greater risk of any vascular complication than were alternative vascular-closure devices. In addition, the study found significantly greater risk of access-site bleeding. The Mynx Control (MC) modified the original Mynx device to facilitate use. The updated MC did not require a new study of outcomes for FDA approval. To evaluate the device, we reviewed our experience using MC for arterial access closure and compared it with our experience with Vascade vascular closure device. We reviewed imaging and medical charts for procedures where MC was deployed by Radiology at a large academic institution from March 2019 to August 2019 and where the Vascade was deployed for 3 months leading to the end of the 2017 academic year. Patient demographics, labs, device used, time to hemostasis and complications were reviewed. For statistical significance, Wilcoxon test is used to test continuous variables and Fisher’s exact for categorical variables. There were 173 cases using MC and 120 cases using the Vascade device for femoral artery access closure. Average time to hemostasis was 6.2 minutes for MC versus 5.3 minutes for Vascade. For the 5F system, time to hemostasis was 6.3 minutes for MC versus 4.5 minutes with Vascade (P < 0.05). For the 6/7F system, time to hemostasis was 6.0 minutes for MC versus 6.5 minutes for the Vascade (P > 0.05). The only reported complications with either device were hematomas treated with manual compression. For the 5F device, hematomas occurred at 1.6% for MC and 2.5% for Vascade (P > 0.05). For the 6/7F device, hematomas occurred at 3.8% for MC and 7.4% for Vascade (P > 0.05). For both MC and Vascade, mean INR was 1.06, but the mean platelet level was 244 for MC versus 235 for Vascade. Our initial experience with MC found a mean time to hemostasis of 6.2 minutes, which was slightly longer than for the Vascade, but the hematoma rate with MC was lower than that with Vascade. Overall hematoma rate for the MC of 2.7% was lower than reported 4.2% rate submitted for original Mynx device’s FDA application.

SAFETY AND EFFECTIVENESS OF MANTA VASCULAR CLOSURE DEVICE AFTER LARGE BORE ARTERIAL ACCESS FOR MECHANICAL CIRCULATORY SUPPORT - INITIAL REAL WORLD EXPERIENCE

Post-FDA approval safety and effectiveness of MANTA (Teleflex) vascular closure device for large bore arterial access closure after mechanical circulatory support is not known. All consecutive MANTA devices used for closure after circulatory support between February 2019 to October 2019 at our

TCT-364 The Closer Large Bore Vascular Sealing System: First-in-Man In-Hospital and Long-Term Experience

Effective arterial access closure following large bore (LB) transfemoral invasive procedure is desirable if it improves patient comfort, mitigates complications, and shortens length of hospital stay. The Closer LB Vascular Sealing System (Closer LB VSS; Rex Medical, Conshohocken, Pennsylvania)

Cutdown Technique is Superior to Fascial Closure for Femoral Artery Access after Elective Endovascular Aortic Repair

Arterial access closure after endovascular aneurysm repair (EVAR) can be achieved using three different approaches: percutaneous closure devices, surgical exposure and direct suture ("cutdown"), and the less invasive fascial closure technique. The aim of this study was to report on the intra-operative, in hospital, and three month outcome of fascial closure and cutdown, and to determine risk factors for failure. The primary outcome was assessed in 439 groins in 225 elective EVAR patients recruited consecutively and prospectively from February 1, 2011 to August 31, 2014. During the study period, fascial closure and cutdown were first and second line closing techniques. Compared with fascial closure, procedures completed with cutdown had lower BMI, thinner subcutaneous tissue of the groin and more complex femoral anatomy. Computed tomographic angiography (CTA) and duplex ultrasound (DUS) of the groin were performed pre-operatively and three months after EVAR. Retrospective review of medical records and CTA were used to determine intra-operative and in hospital outcome, and risk factors for failure. In total, 64%, 33%, and 3% were completed with fascial closure, cutdown, and closure device, respectively. Intra-operative, in hospital, and three month technical success rates of fascial closure vs. cutdown were 91% (283/310 groins) vs. 99% (114/115 groins), 89% (277/310 groins) vs. 99% (114/115 groins), and 89% (275/310 groins) vs. 99% (114/115 groins) (p<.001). Wound complications within three months were infrequent for both methods. No risk factor was significantly associated with failure after fascial closure. This study shows that cutdown is superior to fascial closure for femoral artery access after elective EVAR. In acute EVAR, however, fascial closure is still considered to be a good and fast method, and it has been kept in the present authors' armamentarium for this indication.

Abstract No. 463 First Independent review of the vascade vascular closure device: the only device marketed as “proven” safer than manual compression

In seeking FDA device approval, arterial access closure devices have only sought non-inferiority to manual compression. However, for the Vascade arterial access closure device, the company submitted its sponsored RESPECT trial data finding superiority of its device. Mean time to hemostasis by IR was 5.5 minutes and minor complication rate was 1.1%. No other device has been found superior to manual compression. No other published studies have analyzed this device for arterial access closure. As the MAUDE database illustrates, experiences with devices outside of a controlled trial can deviate from clinical trial data. To evaluate the device in practice, we reviewed our experience using Vascade for arterial access closure. We reviewed imaging and medical charts for procedures where the Vascade was deployed by Radiology at a large academic institution for 3 months leading to the end of the 2017 academic year. Patient demographics, labs, device used, time to hemostasis and complications were reviewed. For statistical significance, Wilcoxon test is used to test continuous variables and Fisher’s exact for categorical variables. There were 120 cases using the Vascade device for femoral artery access closure, 60% used the 5F system and 40% used the 6/7F system. Average time to hemostasis was 5.3 minutes; specifically, 4.5 minutes with the 5F system versus 6.5 minutes with the 6/7F system (p < 0.05). The only reported complications were hematomas treated with manual compression. Hematomas occurred 4.5% of the time with a higher incidence of 7.4% with the 6/7F system versus 2.5% with the 5F system but this was not statistically significant (p = 0.16). Oozing was noted at the access site 2.5% of the time with a slightly higher rate of 4.9% with the 6/7F system versus 0.8% with the 5F system (p = 0.16). The mean patient INR was 1.06 and the mean platelet level was 235. The average patient age was 60 and 46% of the cases involved a male patient. Our experience with the Vascade for arterial access closure had a similar time to hemostasis to the RESPECT trial of just over 5 minutes but our hematoma complication rate of 4.5% was higher than that reported by the RESPECT trial.

Abstract 13431: Safety And Efficacy of Angioseal Deployment in Patients With Common Femoral Artery Access During Electrophysiological Procedures Performed With Uninterrupted Oral Anticoagulation

Introduction: Retrograde access is commonly used during EP procedures to access the aortic root as well as the LV. Many patients who undergo these procedures are under uninterrupted oral anticoagulation (OAC), therefore it is important to find a way to minimize arterial access-site complications. Hypothesis: Femoral arterial access closure devices can be safely used to achieve hemostasis after common femoral artery access in EP procedures performed with uninterrupted OAC. Methods: Consecutive patients who underwent femoral arterial access closure with the AngioSeal device in two centers were included in this retrospective analysis. All patients were systemically heparinized with ACT between 300 and 500 s. Success was defined as hemostasis achieved in &lt; 5 minutes. Results: Over a 2-year period, 62 patients underwent femoral arterial access closure. 52% were PVC/VT ablations, 40% AF (NCC), and 8% SVT (NCC/WPW). 53% of the patients were female, with a mean age of 59 ± 13 years and BMI 30.0 ± 5.2; sheath size was 8F for all. 40% on uninterrupted OAC (24% factor Xa inhibitors, 16% warfarin), whereas 23% were on ASA, 5% on dual antiplatelet therapy, and 32% were not receiving any antithrombotic therapy at the time of the procedure. In all patients with uninterrupted OAC, femoral arterial access was ultrasound-guided to ensure that the arteriotomy was located above the bifurcation but below the external iliac artery. Femoral arterial closure was successful in all, without any device-related complication. There were 2 (3%) access-related complications requiring prolonged hospitalization, both related to the additional venous access, as determined by ultrasound: 1 superficial bleeding in a patient with NCC tachycardia during AF ablation who was on uninterrupted rivaroxaban and 1 large hematoma in a patient who underwent VT ablation and was on ASA. The incidence of complications was not significantly different between patients with uninterrupted OAC compared to those with uninterrupted antiplatelet thereapy or no antithrombotic therapy (Fischer’s exact test P = NS). Conclusions: Common femoral artery access closure with the AngioSeal device is safe and effective in achieving hemostasis in patients undergoing EP procedures performed with uninterrupted OAC.

Patient Satisfaction After Femoral Arterial Access Site Closure Using the ExoSeal® Vascular Closure Device Compared to Manual Compression: A Prospective Intra-individual Comparative Study

To intra-individually compare discomfort levels and patient satisfaction after arterial access closure using the ExoSeal(®) vascular closure device (VCD) and manual compression (MC) in a prospective study design. Patients undergoing two planned interventions from 07/2013 to 09/2014 could participate in the study. Access closure was performed with an ExoSeal(®)-VCD in one and MC in the other intervention. Patients were clinically and sonographically examined and were given questionnaires 1 day after intervention [groin- and back-pain during bedrest (100-point visual analog scale; 0: no pain); comfortability of bedrest (10-point Likert scale, 1: comfortable), satisfaction with closure (10-point Likert scale, 1: very satisfied)]. Results were analyzed in a cross-over design. 48 patients (29 male, median age 62.5 (32-88) years) were included. An ExoSeal(®)-VCD was used first in 25 cases. As four of these subsequently refused MC as second intervention, data from 44 patients could be analyzed. All closures were technically successful (successful device deployment) without major complications. Groin- and back-pain after VCD-use/MC was 0 (0-15) vs. 10 (0-80) and 0 (0-75) vs. 25 (0-90), respectively (p < 0.0001). Bedrest after VCD-use was more comfortable than after MC [1 (range 1-7) vs. 6 (2-10); p < 0.0001]. Satisfaction with the closure procedure and with the intervention in general was higher after VCD-use compared to MC [1 (1-3) vs. 5 (2-10) and 1 (1-2) vs. 2 (1-4), respectively; p < 0.0001]. Intra-individual comparison showed pain levels and discomfort to be significantly lower after ExoSeal(®) use compared to MC. VCD closure was associated with higher satisfaction both with the closure itself and with the intervention in general.

Single-Center Experience Comparing the Application of Small-Caliber versus Large-Caliber Arterial Access Closure in a Consecutive Series of Patients

PurposeTo compare the closure of ≤ 8-F versus 9-F to 12-F femoral access using the 8-F Angio-Seal VIP device (St. Jude Medical, Inc, St. Paul, Minnesota). Materials and MethodsIn this investigator-initiated, retrospective analysis, a consecutive series of 137 patients (n = 92 male patients [67.2%]; overall mean age, 71.0 y ± 9.8) was evaluated. Common femoral artery access was performed in all patients, and either unfractionated heparin or bivalirudin was used for anticoagulation. Access site complications were defined as follows: type 0, no bleeding; type 1, no actionable bleeding; type 2, actionable bleeding. ResultsThe 8-F Angio-Seal VIP device was used for closure of ≤ 8-F femoral access in 76 patients (55.5%) and for 9-F to 12-F femoral access in 61 patients (44.5%). Access site complications were observed after 8-F Angio-Seal deployment in 11 patients (8.0%) (≤ 8 F, n = 5 [6.6%]; 9–12 F, n = 6 [9.8%]; P = .54). Comparing ≤ 8-F with 9-F to 12-F femoral access, type 1 complications were observed in 3 and 6 patients (P = .19) and type 2 complications were observed in 2 and 0 patients (P = .50), respectively. All type 1 complications were managed by applying external compression. Type 2 complications (n = 2 pseudoaneurysms) were treated with thrombin injection in 1 patient and secondary percutaneous intervention in 1 patient. ConclusionsUse of the 8-F Angio-Seal for the closure of > 8-F femoral access is safe and effective. Complication rates when using the 8-F Angio-Seal for closure of ≤ 8-F and 9-F to 12-F femoral access are comparable.

Comparison of the risk of vascular complications associated with femoral and radial access coronary catheterization procedures in obese versus nonobese patients

In this retrospective review of 5,234 cardiac catheterizations and percutaneous coronary interventions, the rate of vascular complications was highest in extremely thin and morbidly obese patients and lowest in moderately obese patients, consistent with the previously reported "obesity paradox." The use of transradial access and arterial access closure devices was associated with reduced vascular complications in the population of obese patients.