Vascular Closure Device Failure 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%.

Strategy for Totally Percutaneous Management of Vascular Injury in Combined Transfemoral Transcatheter Aortic Valve Replacement and Endovascular Aortic Aneurysm Repair Procedures

Minimally invasive treatment of severe aortic stenosis by transcatheter aortic valve replacement (TAVR) and infrarenal abdominal aortic aneurysm by endovascular aortic aneurysm repair (EVAR) requires large-bore vascular access. These percutaneous transfemoral interventions may be performed as a combined procedure, however, vascular injury may necessitate surgical vascular repair. We implemented a strategy designed to enable percutaneous vascular repair, with stent-graft implantation, if necessary, after these combined procedures. We identified all combined percutaneous TAVR and EVAR procedures which were performed at our institution. Patient and procedural characteristics and clinical outcomes were analyzed. Six consecutive patients underwent total percutaneous combined TAVR and EVAR procedures. In all cases, TAVR was performed first and was followed by EVAR. Both common femoral arteries served as primary access sites for delivery of the implanted devices and hemostasis was achieved by deployment of vascular closure devices. Secondary access sites included the right brachial artery in all patients and superficial femoral arteries in 50% of the patients. In all cases an "0.014" 300-cm length "safety" wire was delivered to the common femoral artery or descending aorta by way of a secondary access site to facilitate stent graft delivery. Successful device implantation was achieved in all cases. Vascular closure device failure occurred in 2 patients and was treated by stent graft implantation by way of the brachial and superficial femoral arteries, without need for surgical vascular repair. A strategy designed to facilitate percutaneous vascular repair after combined EVAR and TAVR procedures may enable a truly minimally invasive procedure.

Outcomes with plug-based versus suture-based vascular closure device after transfemoral transcatheter aortic valve replacement: A systematic review and meta-analysis.

Studies comparing plug-based (i.e., MANTA) with suture-based (i.e., ProStar XL and ProGlide) vascular closure devices (VCDs) for large-bore access closure after transcatheter aortic valve replacement (TAVR) have yielded mixed results. To examine the comparative safety and efficacy of both types of VCDs among TAVR recipients. An electronic database search was performed through March 2022 for studies comparing access-site related vascular complications with plug-based versus suture-based VCDs for large-bore access site closure after transfemoral (TF) TAVR. Ten studies (2 randomized controlled trials[RCTs] and 8 observational studies) with 3113 patients (MANTA = 1358, ProGlide/ProStar XL = 1755) were included. There was no difference between plug-based and suture-based VCD in the incidence of access-site major vascular complications (3.1% vs. 3.3%, odds ratio [OR]: 0.89; 95% confidence interval [CI]: 0.52-1.53). The incidence of VCD failure was lower in plug-based VCD (5.2% vs. 7.1%, OR: 0.64; 95% CI: 0.44-0.91). There was a trend toward a higher incidence of unplanned vascular intervention in plug-based VCD (8.2% vs. 5.9%, OR: 1.35; 95% CI: 0.97-1.89). Length of stay was shorter with MANTA. Subgroup analyses suggested significant interaction based on study designs such that there was higher incidence of access-site vascular complications and bleeding events with plug-based versus suture-based VCD among RCTs. In patients undergoing TF-TAVR, large-bore access site closure with plug-based VCD was associated with a similar safety profile as suture-based VCD. However, subgroup analysis showed that plug-based VCD was associated with higher incidence of vascular and bleeding complications in RCTs.

Comparison of plug-based versus suture-based vascular closure for large-bore arterial access: a collaborative meta-analysis of observational and randomized studies

BackgroundLarge-bore arteriotomies can be percutaneously closed with suture-based or plug-based vascular closure device (VCD) strategies. The efficacy of both techniques remains controversial.AimsWe conducted a meta-analysis of comparative studies between both VCD strategies, focusing on the most commonly applied VCDs (MANTA and ProGlide).MethodsWe searched MEDLINE, the Cochrane Central Register of Controlled Trials and Google scholar for observational studies (OS) and randomized controlled trials (RCT) comparing vascular closure with the MANTA-based and the ProGlide-based technique. The principal endpoint of this analysis was access-site related vascular complications. Both study types were analyzed separately.ResultsAccess-site related vascular complications were less frequent after vascular closure with the MANTA technique in the analysis of OS (RR 0.61 [95%CI 0.43–0.89], p = 0.01, I2 = 0%), but more frequent in the analysis of RCT data (RR 1.70 [95%CI 1.16–2.51], p = 0.01, I2 = 0%). Both data sets provided no significant difference between the VCD techniques in terms of overall bleeding events (OS: RR 0.57 [95%CI 0.32–1.02], p = 0.06, I2 = 70%; and RCT: RR 1.37 [95%CI 0.82–2.28], p = 0.23, I2 = 30%). RCT data showed that endovascular stenting or vascular surgery due to VCD failure occurred more often after MANTA application (RR 3.53 [95%CI 1.07–11.33], p = 0.04, I2 = 0%).ConclusionsWhile OS point to favorable outcomes for large-bore vascular closure with the MANTA-based technique, RCT data show that this strategy is associated with more access-site related vascular complications as well as endovascular stenting or vascular surgery due to device failure compared with the ProGlide-based technique.Graphical abstract

Combined strategy for large-bore arteriotomy closure after transcatheter aortic valve implantation

Abstract Background The access site vascular complications remain a relevant complication following transcatheter aortic valve implantation (TAVI). They are frequently associated with vascular closure device failure (VCD). Incidence of vascular complications depends on different factors such as patient's characteristics and clinical risk profile, femoral morphology, access sheath size or technical procedural experience. Their rate is reported between 4–19% [1]. Vascular complications negatively affect morbidity and mortality following TAVI [2]. VCDs that are most commonly used include the suture-based ProGlide and the plug-based MANTA. ProGlide was originally developed for small-bore vessel closure between 6–8F, but a combination of 2 or more devices is suitable for large-bore vessel closure >12F. The MANTA device is originally dedicated for large-bore vessel closure. The MANTA device was not superior to the use of 2 ProGlides in their direct comparison in terms of access site–related vascular complications or access site bleedings. Plug-based VCDs required fewer, but a different kind of bailout maneuvers [3,4]. The alternative and less frequently used strategy is intentional combination of one suture-based VCD – ProGlide with small-bore plug-based VCD AngioSeal. The data supporting this approach are very limited, but showing this concept as a safe, with lower risk of vascular or bleeding complications. Moreover, this strategy requires less additional endovascular interventions when compared with vascular closure using two suture-based VCDs [5]. Methods Retrospectively analysed single centre comparison of two different large-bore vessel closure strategies: two suture-based ProGlides (SB group) vs. intentional combination of one ProGlide with plug-based AngioSeal 8F (CB group). The primary endpoint was occurrence of access site–related vascular complications at 30-days. Results 71 consecutive patients treated between Aug/2020 and May/2021 (SB group) were compared with 68 consecutive patients treated between May/2021 and Jan/2022 (CB group). There wasn`t any significant difference in patient's characteristics between both groups: mean age 80 vs. 81 years, females 53,8% vs. 54,9%, STS score 3,46% vs. 3,47%. The only difference was higher proportion of the patients treated oral anticoagulation in SB group (46,4% vs. 38,5%). The lower rate of vascular complication was observed in CB group 2,9% vs. 7,1%. Moreover, we had to use additional VCD in 14 cases among patients from SB group to achieve haemostasis. Conclusion The intentional combination of one suture-based VCD with one plug-based VCD is effective and safe. This combined strategy was associated with lower rate of vascular complication compare the use of 2 suture-based VCDs in our patient's cohort following TAVI. Funding Acknowledgement Type of funding sources: None.

MANTA Versus Suture-based Closure Devices Following Transcatheter Aortic Valve Replacement: An Updated Meta-analysis

BackgroundVascular access closure is essential in large-bore arteriotomy procedures, such as transcatheter aortic valve replacement. ​Suture-based devices are frequently used for vascular access closure. MANTA (Teleflex) is a collagen plug–based device used to achieve hemostasis with evolving efficacy and safety data. This study aimed to evaluate plug-based versus suture-based closure devices following large-bore arteriotomy procedures.MethodsWe conducted a systematic review searching PubMed, Cochrane Library, and ClinicalTrials.gov (inception through November 2021) for studies evaluating plug-based versus suture-based closure devices following large-bore arteriotomy procedures. We performed a meta-analysis comparing the length of stay, device failure, mortality, bleeding, and vascular complications between these 2 types of devices.ResultsEleven studies (2 randomized controlled trials and 9 observational studies) with a total of 3123 patients were included in this analysis. Compared with suture-based devices, plug-based devices were associated with a significant decrease in the length of stay (standardized mean difference: −0.14; 95% CI, −0.25 to −0.03) and vascular closure device failure (odds ratio, 0.63; 95% CI, 0.44-0.91) following the procedure. There were no significant differences in all-cause mortality, major or minor bleeding, and major or minor vascular complications between plug-based and suture-based closure devices.ConclusionsPlug-based vascular closure devices were associated with a shorter length of stay and lower risk of device failure following large-bore arteriotomy procedures without differences in mortality, bleeding, or vascular complications than suture-based closure devices.

Ultrasound-Guided Versus Conventional MANTA Vascular Closure Device Deployment After Transcatheter Aortic Valve Implantation

Despite the development of device technology and operators' experience, access site vascular complications (VCs) remain one of the major concerns after transcatheter aortic valve implantation (TAVI). MANTA (Teleflex, Wayne, Pennsylvania) is a large-bore vascular closure device (VCD) with promising incidence of VC. Previously, we demonstrated that the ultrasound-guided MANTA (US-MANTA) technique further improved the outcomes compared with conventional MANTA (C-MANTA) without ultrasound guidance. The present study was established to prove the effectiveness of the technique in a larger population. In this study, we included 1,150 patients (335 patients with C-MANTA and 815 with US-MANTA) who received MANTA after TAVI from April 2017 to September 2021. The primary endpoint was MANTA-related VC. Overall VC, VCD failure, and bleeding complications were also assessed based on the Valve Academic Research Consortium 3 criteria. MANTA-related VC occurred in 12.5% in the C-MANTA group and 6.8% in the US-MANTA group (p=0.001). VCD failure rate were 7.5% and 3.9%, respectively (p=0.012). Valve Academic Research Consortium 3 major and minor VC were more frequent in C-MANTA group (major: 7.8% vs 4.4%, p=0.023; minor: 8.1% vs 4.4%, p=0.022). Multivariate analysis revealed US-MANTA as the negative predictor of MANTA-related VC (odds ratio 0.57, 95% confidence interval 0.36 to 0.89, p=0.013). However, subgroup analysis showed the efficacy of the US-MANTA technique was limited to the patients without severely calcified puncture site (P_interaction=0.048). In conclusion, the US-MANTA technique was an effective strategy to reduce VC after transfemoral TAVI compared with C-MANTA.

Pledget-assisted hemostasis to fix residual access-site bleedings after double pre-closure technique.

BACKGROUNDThe use of pre-closure suture-based devices represents a widely access-site hemostasis technique in percutaneous transfemoral transcatheter-aortic-valve-replacement (TF-TAVR); yet this technique is associated with the risk of a device failure that may result in clinically relevant residual bleeding. Thus, a bailout intervention is needed. So far, the best management of pre-closure device failure has not been recognized.AIMTo report the first clinical results obtained using a novel bailout hemostasis technique for patients with double suture-based vascular closure device failure in the setting of TF-TAVR.METHODSWe developed a “pledget-assisted hemostasis” technique to manage residual access-site bleeding. This consists of the insertion of a surgical, non-absorbable, polytetrafluoroethylene pledget over the sutures of the two ProGlide (Abbott Vascular, CA, United States). The ProGlide’s knot-pushers are used to push down the pledget and the hand-made slipknot to seal the femoral artery leak. This technique was used as a bailout strategy in patients undergoing TF-TAVR with a systematic double pre-closure technique. Post-procedural access-site angiography was systematically performed. In-hospital complications were systematically detected and classified according to Valve Academic Research Consortium-2 criteria.RESULTSOut of 136 consecutive patients who underwent TF-TAVR, 15 patients (mean age 80.0 ± 7.2 years, 66.7% female) with access-site bleeding after double pre-closure technique failure were treated by pledget-assisted hemostasis. In the majority of patients, 16F sheath was used (n = 12; 80%). In 2 cases (13%), a peripheral balloon was also inflated in the iliac artery to limit blood loss during pledget preparation. Angiography-confirmed hemostasis (primary efficacy endpoint) was achieved in all patients. After the procedure, 1 patient required blood transfusion (2 units), and no other bleeding or major ischemic complication was noticed. CONCLUSIONThe “pledget assisted hemostasis” might be considered as a possible bailout technique to treat patients with residual access site bleeding. Further studies are needed to compare this approach with other bail-out techniques.

Meta-analysis of ProGlide versus MANTA vascular closure devices for large-bore access site management

IntroductionThe comparative effectiveness of ProGlide® compared with MANTA® vascular closure devices (VCDs) in large-bore access site management is not entirely certain, and has only been evaluated in underpowered studies. This meta-analysis aimed to evaluate the outcomes of ProGlide® compared with MANTA® VCDs. MethodsPubMed, EMBASE, and Cochrane Central Register of Controlled Trials (CENTRAL) were searched systematically for relevant articles from the inception of the database until August 27, 2021. The outcomes of interest were all bleeding events, major bleeding, major and minor vascular complications, pseudoaneurysm, stenosis or dissection, and VCD failure. Risk ratios were used as point estimates of endpoints. All statistical analyses were carried out using R version 4.0.3. ResultsFour observational studies and 1 pilot randomized controlled trial (RCT) were included in the final analysis. There was no significant difference between the ProGlide® and MANTA® groups in the risk of all bleeding events, major/life-threatening bleeding, major vascular complications, minor vascular complications, pseudoaneurysms, and/or stenosis or dissection of the entry site vessel. However, the incidence of VCD failure was higher in the ProGlide® group compared with the MANTA® group (RR 1.94; 95% CI 1.31–2.84; I2 = 0%). ConclusionIn conclusion, both VCDs (ProGlide® and MANTA®) have comparable outcomes with regard to risk of bleeding, vascular complications, pseudoaneurysms, and/or stenosis or dissection of entry vessel. ProGlide® was however associated with higher device failure.

Suture- or Plug-Based Large-Bore Arteriotomy Closure: A Pilot Randomized Controlled Trial.

This study sought to test the superiority in terms of efficacy and safety of a dedicated plug-based vascular closure device (VCD) during transcatheter aortic valve replacement (TAVR) over a suture-based VCD. Vascular complications after TAVR are relevant and often associated with VCD failure. The MASH (MANTA vs. Suture-based vascular closure after transcatHeter aortic valve replacement) trial is an international, 2-center pilot randomized controlled trial comparing the MANTA VCD (Teleflex, Wayne, Pennsylvania) versus 2 ProGlides (Abbott Vascular, Abbott Park, Illinois). The primary composite endpoint consisted of access site-related major or minor vascular complications at 30-days' follow-up. Secondary endpoints included clinically relevant access site bleeding, time to hemostasis, and modified VCD failure (defined as failure to achieve hemostasis within 5min or requiring additional endovascular maneuvers such as endovascular stenting, surgical techniques, or additional closure devices). Adverse events were adjudicated by an independent clinical events committee according to the VARC-2 definitions. A total of 210 TAVR patients were included between October 2018 and January 2020. Median age was 81 years, 54% were male, and the median STS score was 2.7%. There was no significant difference in the primary endpoint of access site-related vascular complications between MANTA and ProGlide (10% vs. 4%; p=0.16). Clinically significant access site bleedings were similar with both closure techniques (9% vs. 6%; p=0.57). Modified VCD failure occurred less frequently in MANTA versus ProGlide (20% vs. 40%; p<0.01). Suture-based closure required more often additional closure devices, whereas MANTA numerically needed more covered stents and surgical bailouts. Plug-based large-bore arteriotomy closure was not superior to suture-based closure. Plug-based closure required fewer, but a different kind of bailout maneuvers.

First Experiences with MANTA Vascular Closure Device in Minimally Invasive Valve Surgery.

To more minimize the minimally invasive valve surgeries, percutaneous vascular access and closure has been used for the establishment of extracorporeal circulation. This study investigates early clinical outcomes of patients who received MANTA for femoral artery closure as first experiences in minimally invasive valve surgery. Between January 2019 and July 2019, 103 consecutive patients (mean age: 58 ± 11 years) underwent video-assisted minimally invasive valve surgery through right anterior minithoracotomy at two cardiac surgery referral centers in Germany. Percutaneous cannulation for cardiopulmonary bypass and femoral artery closure with MANTA were performed in all patients: 18-F and 14-F MANTA were used in 88 (85.4%) and 15 (14.6%) patient, respectively. Mitral, aortic, tricuspid, and double valve surgeries were performed in 51 (49.5%), 39 (37.9%), 7 (6.8%), and 6 (5.8%), patients, respectively. Clinical data were prospectively entered into our institutional database. Cardiopulmonary bypass time and cross-clamping time were 69 ± 23 and 38 ± 14 minutes, respectively. Except for two patients with late pseudoaneurysm on 15th and 23th postoperative day, neither major nor minor vascular complications nor vascular closure device failure according to the Valve Academic Research Consortium-2 definition criteria was observed. Additionally, no wound healing disorders or conversion to surgical closure was observed. MANTA as percutaneous femoral artery closure after decannulation of cardiopulmonary bypass is a safe, feasible, and effective approach and yields excellent early outcomes. Larger size studies are needed to evaluate more the efficacy and safety of MANTA.

Outcomes with MANTA Device for Large-Bore Access Closure after Transcatheter Aortic Valve Replacement: A Meta-Analysis

ABSTRACT Background Data comparing MANTA to other vascular closure devices (VCDs) after TAVR is limited. Methods We performed a meta-analysis of all published studies reporting the outcomes of MANTA vs. other VCDs in TAVR patients. Outcomes included major and minor vascular complications, major and minor bleeding, VCD failure, blood transfusion, additional surgical or endovascular treatment, flow-limiting dissection, hematomas, pseudoaneurysm, change in hemoglobin, and length of stay (LOS). Definitions used were according to the “Valve Academic Research Consortium-2 consensus document” (VARC-2). Results We included five observational studies with a total of 1,410 patients (MANTA n = 601, other VCDs = 809). Three studies compared MANTA to the Proglide device (Abbot Vascular, CA, USA), and two studies compared MANTA to the Prostar XL device (Abbott Vascular, IL, USA). The prevalence of moderate to severe calcification was higher in the MANTA group (31% vs. 21%, p = 0.01) compared with other VCDs group. During the index hospitalization, there was no difference in all major or minor complications between MANTA and other VCDs. In a sensitivity analysis, comparing MANTA to Proglide, the risk of major and minor vascular complications, major and minor bleeding, and VCD failure was similar for both devices. Conclusion In the TAVR population, although more used in calcified vessels, the safety profile and efficacy of the new collagen-based VCD, MANTA, is similar to currently available suture based VCD’s Proglide and Prostar XL.

Large arteriotomies closure using a combination of vascular closure devices during TEVAR/EVAR: A single centre experience

In this case series, we share our experience of total percutaneous closure of large arteriotomies using combination of vascular closure devices (VCD). A total of six patients with seven sites for endovascular repair were taken for total percutaneous endovascular aortic repair. Ten femoral arteriotomies (26 French (F) = 2, 24 F = 1, 22 F = 3, 20 F = 1, 18 F = 1 &16 F = 2) were successfully closed with 26 Perclose™ and 07 Angio-seal™ devices. There were no local site complications or VCD failure in any of our patients.

Incidence, Prognosis and Predictors of Major Vascular Complications and Percutaneous Closure Device Failure Following Contemporary Percutaneous Transfemoral Transcatheter Aortic Valve Replacement

ObjectivesTo determine the incidence, prognosis, and predictors of major Valve Academic Research Consortium (VARC-2) vascular complications (VCs) and percutaneous vascular closure device failure (PCDF) following contemporary percutaneous transfemoral transcatheter aortic valve replacement (TF-TAVR). BackgroundLimited data exists on the incidence and predictors of VCs and PCDFs following percutaneous TF-TAVR using contemporary 14–16 French (F) sheaths. MethodsWe recorded clinical and procedural characteristics, computer tomography (CT) angiographic data, 30-day VCs, mortality, and length of stay (LOS) in all consecutive percutaneous TF-TAVRs at a single center from June 2016 to October 2018. CT measures included common femoral artery (CFA) and external iliac artery (EIA) diameters, sheath to CFA and EIA ratios (SFAR and SEIAR), depth of CFA, extent and location of CFA calcification and pelvic vessel tortuosity (2 bends ≥90°). Multivariable regression was used to predict major VCs and percutaneous closure device failure (PCDF), respectively. ResultsThe final sample consisted of 303 percutaneous TF-TAVRs. Median age was 80 years, 51% were male, 86% Caucasian, 33% had diabetes mellitus (DM) and mean STS score was 5.8 ± 3.8%. Baseline characteristics were similar in patients with vs. without VCs, other than coronary artery disease (CAD) (69% vs. 54%, respectively; p = 0.029) and DM (21% vs. 36%, respectively; p = 0.02). There were 65 (21%) vascular complications: 19 major VCs [6.3%], 29 minor [VCs 9.6%] and 17 PCDFs [5.6%]. Overall, 30-day mortality was low (2.6%). Major VCs were associated with higher mortality (42% vs. 0%, p < 0.0001) while minor VCs (3% vs. 0%, mortality p = 0.99) and PCDFs (3% vs. 0% mortality, p = 0.99) were not. PCDFs were associated with a longer median LOS (4 vs. 3 days, p = 0.02). The independent predictors of major VCs were pelvic vessel tortuosity (OR 3.1; 95% CI 1.1–9.2) and presence of CAD (OR 8.2; 95% CI 1.8–37). Female gender showed a strong trend toward increased risk (OR 3.4; CI 0.84–14; p = 0.086). There were no independent predictors of PCDF. ConclusionContemporary percutaneous TF-TAVR is associated with a low risk of mortality, major VCs and PCDFs. Major VCs confer increased mortality and PCDFs prolong LOS. Pelvic vessel tortuosity and a history of CAD predict major VCs; there were no predictors of PCDFs. These results provide a contemporary update on the incidence and implications of these important vascular complications in the current era of percutaneous TF-TAVR using 14-16F vascular sheaths.

Prophylactic Retrograde Distal Common Femoral Access as a Bail-out Strategy in Patients with Increased Risk for Femoral Access Complication During Transfemoral Aortic Valve Replacement

ObjectiveSeveral patients undergoing transfemoral transcatheter aortic valve replacement (TAVR) have complex peripheral arterial disease (PAD) that increases risk of vascular complications and failure of vascular closure device (VCD). Endovascular bailout of failed VCD is performed through contralateral femoral access. Further due to multiple different anatomic reasons the contralateral femoral access and “up and over” approach is unavailable for endovascular bailout of the VCD failure. We evaluated a novel bailout technique of obtaining an additional access in ipsilateral common femoral artery (CFA) or superficial femoral artery (SFA) distal to the main CFA access used for TAVR device. MethodsWe prospectively identified patients who were at high risk for VCD failure and had unavailable contralateral CFA approach from the pre-TAVR evaluation with multislice CT angiography. The data was collected prospectively for the TVT registry and retrospectively reviewed. All patients had an additional distal access obtained in the CFA or proximal SFA under direct fluoroscopy guidance after achieving main CFA access for TAVR. Using an inner 0.021″ micro-dilator from the 4-Fr micropuncture mini stick max access kit (AngioDynamics, Marlborough, MA) and a 200 cm long 0.018″ wire, the distal access was secured in place through the TAVR procedure. After completing the TAVR if the VCD gained successful hemostasis, the 0.021″ dilator was removed with manual pressure. If the VCD failed to achieve hemostasis, the distal access was upsized to a 7 Fr sheath for carrying out endovascular repair of the TAVR access. If the distal access was upsized to 7 Fr, that access was treated with VCD. The patients were monitored for acute in-hospital complication and followed for 6 months. ResultsDuring 2017 & 2018, 97.4% of 186 TAVRs were performed via femoral approach at our center. Six patients met the criteria for high-risk access and non-availability of the contralateral “up and over” approach. Of the 6 patients enrolled in this prospective study, 3 required endovascular management of TAVR access because of failed VCDs and were treated with covered stents using the distal ipsilateral access. The remaining 3 patients had successful use of VCDs for the TAVR access and the prophylactic access with 0.021″ dilator was managed with manual pressure. None of the six patients suffered any further vascular complication or bleeding. At the 6-month follow up no vascular complications or clinically driven events were identified from the TAVR access or additional distal ipsilateral access. ConclusionThis novel technique of prophylactic ipsilateral distal femoral access can provide an alternative bailout strategy for patients at high risk of closure device failure and unavailable contralateral femoral approach during transfemoral TAVR.

Development, preclinical evaluation and validation of a novel quick vascular closure device for transluminal, cardiac and radiological arterial catheterization.

Following percutaneous coronary intervention, vascular closure devices (VCDs) are increasingly used to reduce time to ambulation, enhance patient comfort, and reduce potential complications compared with traditional manual compression. Newer techniques include complicated, more or less automated suture devices, local application of pads or the use of metal clips and staples. These techniques often have the disadvantage of being time consuming, expensive or not efficient enough. The VCD failure rate in association with vascular complications of 2.0-9.5%, depending on the type of VCD, is still not acceptable. Therefore, the aim of this study is to develop a self-expanding quick vascular closure device (QVCD) made from a bioabsorbable elastic polymer that can be easily applied through the placed introducer sheath. Bioabsorbable block-co-polymers were synthesized and the chemical and mechanical degradation were determined by in vitro tests. The best fitting polymer was selected for further investigation and for microinjection moulding. After comprehensive haemocompatibility analyses in vitro, QVCDs were implanted in arterial vessels following arteriotomy for different time points in sheep to investigate the healing process. The in vivo tests proved that the new QVCD can be safely placed in the arteriotomy hole through the existing sheath instantly sealing the vessel. The degradation time of 14 days found in vitro was sufficient for vessel healing. After 4 weeks, the remaining QVCD material was covered by neointima. Overall, our experiments showed the safety and feasibility of applying this novel QVCD through an existing arterial sheath and hence encourage future work with larger calibers.

MANTA versus ProGlide vascular closure devices in transfemoral transcatheter aortic valve implantation

BackgroundThe MANTA system is a novel vascular closure device (VCD) and its safety and efficacy were compared to the ProGlide VCD in patients undergoing transfemoral transcatheter aortic valve implantation (TAVI). MethodsThis is a retrospective study including 222 patients who underwent transfemoral TAVI at three Finnish University Hospitals. The MANTA VCD was used in 107 patients and their outcome was compared with that of 115 patients in whom the arterial access was closed with the ProGlide VCD. ResultsVARC-2 VCD failure occurred less frequently in the MANTA cohort (3.7% vs. 7.8%, p = 0.378), but the difference did not reach statistical significance. When adjusted for the introducer outer diameter, the MANTA cohort had similar rates of VARC-2 major vascular complications (9.3% vs. 12.2%, adjusted: p = 0.456), VARC-2 life-threatening/disabling bleeding (9.3% vs. 6.1%, adjusted: p = 0.296) and need of invasive treatment of bleeding (4.7% vs. 7.0%, adjusted: p = 0.416) compared to the ProGlide cohort. Additional VCDs were more frequently needed in the ProGlide cohort (58.3% vs. 1.9%, p < 0.0001). ConclusionsIn patients undergoing transfemoral TAVI, the MANTA VCD showed a similar risk of VARC-2 vascular and bleeding complications compared to the ProGlide VCD, but it reduced significantly the need of additional VCDs for completion of hemostasis.

Retrospective Evaluation of Percutaneous Access for TEVAR and EVAR: Time to Make it the Standard Approach?

Introduction To evaluate the safety of percutaneous endovascular aortic repair and the relationship of access site characteristics to complications Materials and Methods All patients undergoing percutaneous TEVAR, EVAR and FEVAR procedures from January 2010 to May 2016 were retrospectively analysed for incidence of complications and their relationship to various access site characteristics like access artery size, degree of vessel calcification, skin to artery distance and sheath to artery ratio. Hemostasis occurring within 15 min after suture closure with or without manual compression was defined as primary hemostasis. Results 92 patients with 142 femoral access sites were included in the study. Median follow-up was 28.13 months (range 2.5 - 76.7 months, Mean 32.39, SD - 21.66 months). Introducer system size ranged from 12F to 25F. Primary haemostasis was achieved in 97.1 % (138/142) of the total femoral access sites. Four access sites (2.8 %) had to be closed surgically; in all 4 cases the introducer systems was ≥ 18F. Two of these access sites had been operated upon previously. Late complications including inguinal hematoma (n = 7), wound infection (n = 1), scrotal hematoma (n = 1), pseudoaneurysm (n = 4) and late bleeding (n = 4) occurred in 17 access sites (11.9 %), of which 13 were managed conservatively. On account of the low complication rate, no correlation between the evaluated variables and observed complications could be established. Conclusion Percutaneous endovascular aortic repair is feasible and safe irrespective of the size of the introducer sheath and the nature of aorto-iliac pathology. The technical success rate is high and the incidence of complications is low. Early complications are most often associated with sheath sizes ≥ 18 F. The majority of the late complications can be treated conservatively. Key points: · Percutaneous endovascular aortic repair is feasible and safe.. · Technical success rate is high and complication rate is low.. · Vascular closure device failure in the occasional patient may necessitate surgical intervention.. Citation Format · Thomas RP, Kowald T, Schmuck B et al. Retrospective Evaluation of Percutaneous Access for TEVAR and EVAR: Time to Make it the Standard Approach?. Fortschr Röntgenstr 2017; 189: 347 - 355.

Risk factors for vascular access-related complications in patients undergoing early invasive strategy

ABSTRACT Background The knowledge of risk factors related to vascular access complications in patients undergoing early invasive strategy allows the adoption of methods to minimize them. Methods We performed a subanalysis of the ARISE study, aiming to identify predictors of vascular complications in patients randomized to the radial or femoral techniques with the use of vascular closure device (VCD). Results A total of 240 patients with a mean age of 63.0 ± 10.7 years were included, with 30.8% of diabetics. Except for a higher prevalence of women in the radial group, there were no clinical differences between the groups. Percutaneous coronary intervention was performed in 86.7% of the cases. The rate of vascular complications after 30 days was 13.3% in the radial group, due to hematoma > 5 cm (6.7%) and asymptomatic artery occlusion (5.8%), and 12.5% in femoral group, due to hematoma > 5 cm, without significant difference. The following were identified as risk factors for vascular access complications: body mass index (BMI), previous stroke, longer duration of the procedure, and VCD failure. At the stratified analysis, female gender and high or very high-risk CRUSADE score were predictors of complications only for the femoral group. In the multivariate model, the factors that remained significant were BMI and VCD failure. Conclusions The radial and femoral techniques, with the use of VCD, shared variables that were predictors of complications. Risk factors, such as female gender and high-risk CRUSADE score, were attenuated by the use of the radial technique.

Routine use of ultrasound-guided access reduces access site-related complications after lower extremity percutaneous revascularization

We sought to elucidate the risks for access site-related complications (ASCs) after percutaneous lower extremity revascularization and to evaluate the benefit of routine ultrasound-guided access (RUS) in decreasing ASCs. We reviewed all consecutive percutaneous revascularizations (percutaneous transluminal angioplasty or stent) performed for lower extremity atherosclerosis at our institution from 2002 to 2012. RUS began in September 2007. Primary outcome was any ASC (bleeding, groin or retroperitoneal hematoma, vessel rupture, or thrombosis). Multivariable logistic regression was used to determine predictors of ASC. A total of 1371 punctures were performed on 877 patients (43% women; median age, 69 [interquartile range, 60-78] years) for claudication (29%), critical limb ischemia (59%), or bypass graft stenosis (12%) with 4F to 8F sheaths. There were 72 ASCs (5%): 52 instances of bleeding or groin hematoma, nine pseudoaneurysms, eight retroperitoneal hematomas, two artery lacerations, and one thrombosis. ASCs were less frequent when RUS was used (4% vs 7%; P = .02). Multivariable predictors of ASC were age >75 years (odds ratio [OR], 2.0; 95% confidence interval [CI], 1.1-3.7; P = .03), congestive heart failure (OR, 1.9; 95% CI, 1.1-1.3; P = .02), preoperative warfarin use (OR, 2.0; 95% CI, 1.1-3.5; P = .02), and RUS (OR, 0.4; 95% CI, 0.2-0.7; P < .01). Vascular closure devices (VCDs) were not associated with lower rates of ASCs (OR, 1.1; 95% CI, 0.6-1.9; P = .79). RUS lowered ASCs in those >75 years (5% vs 12%; P < .01) but not in those taking warfarin preoperatively (10% vs 13%; P = .47). RUS did not decrease VCD failure (6% vs 4%; P = .79). We were able to decrease the rate of ASCs during lower extremity revascularization with the implementation of RUS. VCDs did not affect ASCs. Particular care should be taken with patients >75 years old, those with congestive heart failure, and those taking warfarin.