Suture-based Vascular Closure Devices Research Articles

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

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

Two different hybrid vascular access closure strategies post transcatheter aortic valve implantation

Abstract Background The hybrid strategy combining plug-based and suture-based vascular closure devices (VCD) was introduced as a promising technique for vascular access hemostasis after transcatheter aortic valve implantation (TAVI) with satisfactory outcomes. However, data comparing two plug-based VCDs each in the combination with a suture-based VCD, namely ProGlide/FemoSeal (P/FS) with ProGlide/AngioSeal (P/AS) VCDs, is still lacking. Aim To compare the 30-day outcome of the hybrid strategy using P/AS versus P/FS for vascular access site closure after TAVI. Methods A retrospective single Centre observational study included 608 patients recruited from a prospective TAVI registry between 2016 and 2022. The composite endpoint was defined as any VCD related major vascular complications and/or bleeding more than type 1 according to Valve Academic Research Consortium (VARC-3) criteria. Results The current study reported a significantly higher rate of composite endpoint in P/AS group, which was driven by higher rate of major bleeding (5.4% vs 1.4%, p=0.036). We also found a higher rate of VCD related minor bleeding in P/AS group (16.3% vs 8.1%, p=0.013). Successful access site hemostasis was achieved in 83.1% of P/FS group versus 71.7% in P/AS group (p=0.006). The presence of anterior wall calcification at the access site was significantly associated with the composite endpoint (adj OR 2.49; 95% CI (1.08 – 5.75), p=0.032). Conclusions The hybrid strategy for large bore vascular access closure using P/FS showed a potentially better 30-day outcomes compared with P/AS. The presence of anterior calcification at the access site carries a significant risk of VCD related complications.

ProGlide-AngioSeal versus ProGlide-FemoSeal for vascular access hemostasis posttranscatheter aortic valve implantation.

The hybrid strategy combining plug-based and suture-based vascular closure devices (VCD) was introduced as a promising technique for vascular access hemostasis after transcatheter aortic valve implantation (TAVI) with satisfactory outcomes. However, data comparing two plug-based VCDs each in the combination with a suture-based VCD, namely ProGlide/AngioSeal (P/AS) with ProGlide/FemoSeal (P/FS) VCDs, is still lacking. To compare the 30-day outcome of the hybrid strategy using P/AS versus P/FS for vascular access site closure after TAVI. A retrospective single-center observational study included 608 patients recruited from a prospective TAVI registry between 2016 and 2022. The composite endpoint was defined as any VCD-related major vascular complications and/or bleeding more than type 1 according to Valve Academic Research Consortium criteria. The current study reported a significantly higher rate of composite endpoint in P/AS group, which was driven by a higher rate of major bleeding (5.4% vs. 1.4%, p = 0.036). We also found a higher rate of VCD-related minor bleeding in P/AS group (16.3% vs. 8.1%, p = 0.013). Successful access site hemostasis was achieved in 71.7% of P/AS group versus 83.1% in P/FS group (p = 0.006). The presence of anterior wall calcification at the access site was significantly associated with the composite endpoint (adj odds ratio 2.49; 95% confidence interval (1.08-5.75), p = 0.032). The hybrid strategy for large bore vascular access closure using P/FS showed a potentially better 30-day outcomes compared with P/AS. The presence of anterior calcification at the access site carries a significant risk of VCD-related complications.

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

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

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

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

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%.

A study of bailout plug-based closure after failed suture-based closure in patients undergoing transfemoral TAVI.

Percutaneous suture-based arterial access site closure (ProGlide) is commonly applied in patients undergoing transfemoral transcatheter aortic valve implantation (TAVI). However, the failure of a suture-based vascular closure device (VCD) may require additional treatment. We aimed to evaluate the efficacy and safety of bailout access site closure using a large-bore plug-based device (MANTA) in patients with failed suture-based closure during transfemoral TAVI. Patients undergoing a bailout attempt with the MANTA VCD were identified from a prospectively enrolling, institutional registry. Efficacy was defined as haemostasis at the access site without the need for alternative treatment other than manual compression or endovascular ballooning. Safety was defined as freedom from vascular dissection, stenosis and occlusion requiring intervention. Of 2,505 patients, 66 underwent a bailout attempt with MANTA as a result of ProGlide failure, which occurred before the large-bore sheath insertion in 16.7% of patients and after the sheath removal in 83.3% of patients. Bailout MANTA was deemed effective in 75.8% of patients (50/66), and the technique was considered safe in 86.4% (57/66) of patients. Failure of bailout MANTA occurred because of its superficial application, resulting in persistent bleeding in 18.2% of patients (12/66), and because of its deep application, resulting in stenosis or occlusion in 6.1% of patients (4/66). Operator experience with the technique (odds ratio [OR] 12.29, 95% confidence interval [CI]: 1.99-75.99; p=0.007) and prior use of three ProGlides (OR 0.02, 95% CI: <0.01-0.39; p=0.010) were the only independent predictors of the efficacy endpoint. Bailout MANTA after ProGlide failure was effective and safe, but operator experience seems to be crucial. Further technological refinements to facilitate accurate placement appear necessary.

Suture-Based Vascular Closure Versus Surgical Closure of Large Bore Arteriotomies: A Real-World Experience.

With the introduction of transcatheter aortic valve implantation (TAVI), endovascular abdominal aortic aneurysm repair (EVAR), thoracic endovascular aortic aneurysm repair (TEVAR), and frequent use ofleft ventricular assist devices in complicated percutaneous coronary interventions, the use of large bore arterial access has become a necessity. In the index study, we compared the percutaneous closure of large arteriotomies with open surgical (OS) closure. It was a prospective study in which we compared the technical success and vascular complication rate associated with the use of a suture-based vascular closure device (VCD): Perclose ProGlide(PP) with that of OS closure. The study was carried out at Command Hospital Air Force,Bengaluru, India, from January 1, 2016, toDecember 31, 2020. The inclusion criteria were any percutaneous intervention involving large bore arterial access (≥12 French (F) sheath). The exclusion criteria were any condition where a persistent need for vascular access at the end of the procedure was required. We noted the baseline characteristicsand type of anesthesia for all patients. The primary outcome was technical success and major vascular complications, which included major local site bleeding: Bleeding Academic Research Consortium (BARC) 3 or more, failed hemostasis requiring a second intervention, and acute vessel occlusion. Total time taken for the procedure (TTP), time to ambulation (TTA), and time to discharge post-procedure (TTD) were noted for each patient. The secondary outcomes were any bleeding other than major, local hematoma sized >5 cm at 24 hours, pseudo aneurysm formation at 30 days, and acute limb ischemia at 30 days. A total of 120 patients (PP: 60 (males: 54, females: 6), OS: 60 (males: 50, females: 10)) were included in this study.The mean age of patients was comparable in both groups (PP: 71.8 ± 9.62 years and OS: 71.0 ± 7.76 years, p-value: 0.63). Total large arteriotomies (mean size: 18.03F ± 3.34) closed were 184 (PP: 90, OS: 94). The procedures performed were EVAR: 64 (PP: 30, OS: 34), TAVI: 38 (PP: 21, OS: 17), and TEVAR: 18 (PP: 9, OS: 9). All patients in PP group received dual ProGlide with preclose technique. All TEVAR procedures (total arteriotomies: 18) required a vascular sheath of ≥ 24F.There was no statistical difference between the mean size of sheaths used in the two groups. The technical success (PP: 95.55%, OS: 97.87%, 95% CI: -5.78%-10.98%, p-value: 0.48) and rate of major complications were similar in both groups. Three patients in the PP group who had failed hemostasis with two ProGlides were successfully managed with one additional Angioseal (6F) each.The occurrence of hematoma sized larger than 5 cm was significantly more in the PP group compared to the OS group (PP: 7 (7.78%), OS: 0 (0%), p-value: 0.006). While GA was used for all patients who underwent vascular closure with OS, only eight patients (13.33%) in the PP group required GA. The TTP, TTA, and TTD were significantly lower in the PP group as compared to the OS group. The percutaneous closure of large bore arteriotomies with suture-based VCDs is equally effective and is not associated with increased major vascular complications. In fact, the TTP, TTA, and TTD are significantly lower in the PP group which can translate to better patient comfort and lower costs.

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.

Predictable Deployment of Suture-Based Vascular Closure Device Before Transfemoral Transcatheter Aortic Valve Replacement

Predictable Deployment of Suture-Based Vascular Closure Device Before Transfemoral Transcatheter Aortic Valve Replacement

Clinical outcomes of MANTA vs suture-based vascular closure devices after transcatheter aortic valve replacement: An updated meta-analysis

ObjectiveA recently published randomized control trial showed different results with suture-based vascular closure device (VCD) than plug-based VCD in patients undergoing transfemoral transcatheter aortic valve replacement (TAVR). The learning curve for MANTA device is steep, while the learning curve for suture based VCD is shallow as the devices are quite different. In this meta-analysis, we have compared suture-based (ProGlide and Prostar XL) vs plug-based VCDs (MANTA). MethodsWe performed a meta-analysis of all published studies (using PubMed/Medline and Cochrane databases) reporting the clinical outcome of plug-based vs suture-based VCDs in transfemoral TAVR patients. ResultsWe included nine studies with a total of 2865 patients (plug-based n = 1631, suture-based n = 1234). There was no significant difference in primary outcome of all bleeding when using plug-based as opposed to suture-based VCDs (RR 1.14 [0.62–2.06] I2 = 72%). There was no significant difference in the incidence of secondary outcomes between two groups including major life threatening bleeding (RR 1.16 [0.38–3.58] I2 = 65%), major vascular complications (RR 0.84 [0.35–2.00] I2 = 55%), minor vascular complications (RR 1.05 [0.56–1.95] I2 = 42%), pseudo aneurysm (RR 1.84 [0.11–29.98] I2 = 44%), stenosis-dissection (RR 0.98 [0.66–1.47] I2 = 0%), VCD failure (RR 1.71 [0.96–3.04] I2 = 0%), and blood transfusion (RR 1.01 [0.38–2.71], I2 = 61%). ConclusionLarge bore arteriotomy closure with plug-based VCD was not superior to suture-based VCDs in this transfemoral TAVR population. There was very frequent use of secondary VCDs in suture-based VCD group which is not practical when using MANTA. Additional high-powered studies are required to determine the safety and efficacy of MANTA device.

1019 SAFETY OF PLUG-BASED AND SUTURE-BASED VASCULAR CLOSURE DEVICES IN PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT: A MULTICENTER OBSERVATIONAL STUDY

Abstract Background Transcatheter aortic valve replacement (TAVR), is the treatment of choice for most patients with aortic stenosis. Transfemoral access remains the most widely used peripheral vascular approach for TAVR and dedicated plug-based or suture-based vascular closure devices are available to achieve femoral hemostasis. However, the comparative safety of such strategies is controversial in patients undergoing transfemoral TAVR. Objectives in this study, we aimed to evaluate the rates of vascular access complications according to the use of plug-based or suture-based vascular closure in patients undergoing TAVR. Methods Data were retrospectively collected from two high-volume TAVR centers from September 2009 to March 2022. Patients were categorized according to the use of plug-based or suture-based vascular closure devices. The plug-based platform used was MANTA (Teleflex), while the suture-based devices were the Perclose ProGlide™ or the Prostar™ Systems (Abbott Vascular). Baseline demographic, clinical, and echocardiographic variables were compared between these groups using an independent-sample Student's t-test for continuous variables, presented as mean±SD, and the chi-square test for categorical or binary variables, presented as number and percentage, as appropriate. The odds ratio (OR) for vascular complications was calculated using a multivariate logistic regression model including as dependent variables all relevant baseline and procedural characteristics. The closure device variable was included in the multivariate model using the Prostar™ XL device group as reference. Vascular complications were adjudicated according to the Valve Academic Research Consortium definitions 3. Results Out of 874 patients, hemostasis was achieved with Prostar™ XL PVS in 120 (13.7%) patients, with Perclose ProGlide™ in 525 (60.1%), and with MANTA 229 (26.2%). No differences in age and common cardiovascular risk factors were observed between the group except for the prevalence of peripheral arterial disease (30.6% vs. 17.0%, p&amp;lt;0.0001) and dyslipidemia (58.9% vs. 68.6%, p=0.01) as well as for the echo and procedural variables except for the Euroscore II that was lower in the plug-based group (6.0±5.6 vs. 5.1±4.68), and for the higher use of new generation devices (79.1% vs. 98.3%, p&amp;lt;0.0001). After adjustment for common cardiovascular risk factors and procedural features, no differences were observed for total vascular complications [OR: 0.68 (95% confidence interval (CI): 0.33 to 1.38) and OR: 0.60 (95% CI: 0.33 to 1.53), for Perclose ProGlide™ and MANTA groups, respectively]. Likewise, no substantial differences were observed for major and minor vascular complications. Conclusions Both suture-based and plug-based devices have comparable outcomes with regard to the risk of vascular complications. Further randomized clinical trials are warranted to confirm this observation in high-risk sub-group patients with for example heavily calcified access or obesity.

Comparison of Suture-Based and Collagen-Based Vascular Closure Devices for Large Bore Arteriotomies-A Meta-Analysis of Bleeding and Vascular Outcomes.

Background: Large bore access procedures rely on vascular closure devices to minimize access site complications. Suture-based vascular closure devices (S-VCD) such as ProGlide and ProStar XL have been readily used, but recently, newer generation collagen-based vascular closure devices (C-VCD) such as MANTA have been introduced. Data on comparisons of these devices are limited. Methods: PubMed, Scopus and Cochrane were searched for articles on vascular closure devices using keywords, (“Vascular closure devices” OR “MANTA” OR “ProStar XL” OR “ProGlide”) AND (“outcomes”) that resulted in a total of 875 studies. Studies were included if bleeding or vascular complications as defined by Valve Academic Research Consortium-2 were compared between the two types of VCDs. The event level data were pooled across trials to calculate the Odds Ratio (OR) with 95% CI, and analysis was done with Review Manager 5.4 using random effects model. Results: Pooled analyses from these nine studies resulted in a total of 3410 patients, out of which 2855 were available for analysis. A total of 1229 received C-VCD and 1626 received S- VCD. Among the patients who received C-VCD, the bleeding complications (major and minor) were similar to patients who received S-VCD ((OR: 0.70 (0.35–1.39), p = 0.31, I2 = 55%), OR: 0.92 (0.53–1.61), p = 0.77, I2 = 65%)). The vascular complications (major and minor) in patients who received C-VCD were also similar to patients who received S-VCD ((OR: 1.01 (0.48–2.12), p = 0.98, I2 = 52%), (OR: 0.90 (0.62–1.30), p = 0.56, I2 = 35%)). Conclusions: Bleeding and vascular complications after large bore arteriotomy closure with collagen-based vascular closure devices are similar to suture-based vascular closure devices.

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.

A Comparison of Efficacy, Safety and Cost Between MANTATM and Proglide Vascular Closure Devices Following Transfemoral Transcatheter Aortic Valve Implantation

Aims Access site vascular complications remain a recognised complication following transcatheter aortic valve implantation (TAVI). Suture-based vascular closure devices (VCDs) such as ProGlide® (Abbott Vascular Inc., Santa Clara, CA, USA) are widely used in order to achieve rapid haemostasis. The MANTATM (Essential Medical Inc., Malvern, PA, USA) is a collagen plug-based VCD which can be used as an alternative to traditional suture-based devices, but is significantly more expensive per-unit. We compare the efficacy, safety and total cost associated with the use of the MANTATM and ProGlide® VCDs. Methods This retrospective study included all consecutive patients who underwent transfemoral (TF) TAVI between November 2017-June 2018. The primary endpoints were primary access site-related VARC-2 vascular complications, VARC-2 bleeding and the overall per-patient cost incorporating treatment for complications or use of additional VCDs. Results A total of 136 patients were included in this study; 86 in the ProGlide® group and 50 in the MANTATM group. Baseline characteristics of the two groups were well-matched. Three patients in the ProGlide® group required surgical repair compared to none in the MANTATM group. However, no significant differences were observed with respect to overall primary access site-related VARC-2 vascular complications (10.5% vs. 10%; p=0.93) or VARC-2 bleeding (9.3% vs. 4.0%; p=0.25). There was no significant difference in the mean cost per patient when taking into consideration the use of additional VCDs and treatments for vascular complications (£568.79 vs. £599.95; p=0.90). Conclusion The use of the MANTATM VCD following TF TAVI is cost-neutral compared to ProGlide® VCDs, whilst being associated with no increase in VARC-2 vascular or bleeding complications.

Comparison of suture-based and collagen-based vascular closure devices for large bore arteriotomies- an updated meta-analysis of bleeding and vascular complications

Abstract Background Large bore access procedures such as transcatheter aortic valve replacement or mechanical circulatory support devices rely on percutaneous vascular closure devices to minimize access site complications. Suture-based vascular closure devices (S-VCD) have been readily used but recently newer generation collagen-based vascular closure devices (C-VCD) have been introduced to ensure minimally invasive nature of large bore devices and prevent vascular and bleeding complications at the access site. However, large population data on outcomes of these devices is lacking. Purpose To compare the bleeding and vascular complications of suture-based and collagen- based vascular closure devices for large bore access. Methods PubMed was searched for articles on vascular closure devices using keywords, (“Vascular closure devices”) AND (“bleeding OR vascular complications”) that resulted in a total of 456 studies. Studies were included if bleeding or vascular complications as defined by Valve Academic Research Consortium-2 (VARC-2) were compared between the two types of VCDs. 6 (5 observational and 1 Randomized controlled trial) studies met the inclusion criteria. The event level data was pooled across trials to calculate Odds Ratio (OR) with 95% CI and analysis was done using Review Manager 5.4 (RevMan 5.4). Random effect model was used in RevMan 5.4 for the analysis and p value of &amp;lt;0.05 was deemed significant. Results Pooled analyses from these 6 trials resulted in a total of 1,307 patients, out of which 550 received C-VCD and 757 received S- VCD. Among the patients who received C-VCD, the bleeding complications (major and minor) were non significantly lower than in patients who received S-VCD ((OR: 0.71 (0.33–1.53), p=0.38, I2=47%), (OR: 0.78 (0.40–1.50), p=0.45, I2=52%)). The vascular complications (major and minor) in patients who received C-VCD were similar to patients who received S-VCD ((OR: 0.85 (0.47–1.54), p=0.59, I2=0%), (OR: 0.92 (0.38–2.22), p=0.86, I2=37%)) (Picture 1 and Picture 2). Conclusions Bleeding and vascular complications after large bore arteriotomy closure with collagen based vascular closure devices are similar to suture based vascular closure devices. Therefore, collagen-based devices seem to be a feasible option to obtain hemostasis in large bore arteriotomies without increasing risk for vascular complications. Funding Acknowledgement Type of funding sources: None.

Totally Percutaneous Transfemoral Transcatheter Aortic Valve Replacement Despite Failure to Deploy a Vascular Closure Device: A Single-Centre Case Series

Transcatheter aortic valve replacement (TAVR) is preferably performed as a completely percutaneous procedure via transfemoral access. Suture-mediated vascular closure devices are deployed prior to sheath insertion (pre-closure). Inability to perform pre-closure may necessitate surgical vascular repair of the femoral artery. Patients at increased risk of vascular surgery complications may benefit from a percutaneous method for achieving access site haemostasis. Stent graft implantation is commonly used for treating access site injury following TAVR. This study assessed the feasibility of a strategy of planned stent graft implantation within the femoral artery for achieving access site haemostasis in patients undergoing transfemoral TAVR and in whom vascular pre-closure was not possible. A prospective institutional TAVR registry was retrospectively analysed and a cohort of patients were identified who were selected for transfemoral valve delivery and in whom pre-closure failed and access site haemostasis was achieved by stent graft implantation. This strategy was used for achieving access site haemostasis in 11 patients (1.5% of 744 patients undergoing transfemoral TAVR). These patients were considered to be at increased risk of vascular surgery complications due to advanced age, frailty, comorbidities, or immobility. Stent graft implantation achieved access site haemostasis in all patients. During follow-up, 30-day mortality was zero, 1-year mortality was 27%, and none of the patients required additional vascular interventions. The preliminary data suggest that planned stent graft implantation within the femoral artery may achieve access site haemostasis and enable a totally percutaneous TAVR procedure, despite failure to perform pre-closure with a suture-based vascular closure device.

A Randomized Trial Comparing Polymer Versus Suture-Based Vascular Closure Devices for Arterial Closure Following Lower-Limb Arterial Endovascular Revascularization

The primary objective of this study (STEP trial) was to compare the efficacy of the polymer-based FemoSeal® vascular closure device (VCD) and the suture-based ProGlide® VCD in achieving hemostasis at the femoral access site after lower-limb arterial endovascular revascularization. STEP was a multicenter randomized clinical trial including patients undergoing lower-limb arterial endovascular revascularization. The primary endpoint was technical success 5h after the VCD intervention, defined as achievement of hemostasis without the need for a follow-up intervention at the access site and without a 2-g/dL drop in hemoglobin. Between December 2017 and April 2019, 113 patients were assigned to the FemoSeal® group (FS) and 117 to the ProGlide® group (PG). VCD interventions were technically successful for 90 FS patients (80%) and 58 PG patients (50%) (odds ratio, 3.98; 95%CI, 2.22 to 7.14; p < 0.0001). This difference in success rates between FS and PG is partly explained by more frequent recourse to manual compression (FS: n = 19; PG: n = 45) and an additional VCD (FS: n = 0; PG: n = 23) in the latter group. After 5h, 87% of FS patients and 69% of PG patients resumed ambulation (odds ratio: 3.07; 95%CI: 1.93 to 6.15; p = 0.0016). In patients undergoing lower-limb arterial endovascular revascularization, FemoSeal® was superior to ProGlide® in terms of technical success. Step trial was registered on http://ClinicalTrials.gov (NCT03192033).

Propensity-matched comparison of large-bore access closure in transcatheter aortic valve replacement using MANTA versus Perclose: A real-world experience.

Compare two large-bore vascular closure devices (VCDs), collagen-plug-based MANTA and suture-based dual Perclose ProGlide (PP), in patients undergoing contemporary transfemoral transcatheter aortic valve replacement (TAVR). The SAFE MANTA IDE clinical trial demonstrated that the collagen-plug-based MANTA VCDs were safe and effective in closing large-bore arteriotomies. However, data comparing this collagen-plug-based VCD to the suture-based VCD in contemporary practice are sparse. This was a retrospective observational study in which we screened transfemoral (TF) TAVR patients at our institution from 2017 to 2020. Included were those whose large-bore TF access was closed using either MANTA or PP with and without Angio-Seal. Our primary outcome was VCD success. Additional in-hospital outcomes included major and minor vascular complications, post-TAVR length of stay, and mortality. We screened 696 patients who underwent TAVR. Using propensity scores, we matched 124 patients who received MANTA with 124 patients who received PP. Patients had a mean age of 77.2 years, 69.0% were men, and their mean Society of Thoracic Surgeons score was 3.4%. VCD success was equivalent between VCDs (95.2% vs. 95.2%; p= 1.000). Patients had similar rates of mortality (0% vs. 0.8%; p= .316), and no patients had major vascular complications. In contemporary TAVR, the collagen-plug-based MANTA VCD appears to be as safe and effective as the suture-based dual PP VCD, with no differences in VCD success, vascular complications, or mortality. Therefore, selection of VCD for TAVR should be left to operator discretion, taking into account anatomical considerations.

Real-world experience of suture-based closure devices: Insights from the FDA Manufacturer and User Facility Device Experience.

We analyzed post-marketing surveillance data from the United States Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database for suture-based vascular closure devices (VCDs) - Perclose ProGlide (Abbott, Chicago, Illinois) and Prostar XL (Abbott). Suture-based VCDs are mostly used for large-bore femoral arterial access-site closure. Real-world, contemporary experience on the most commonly reported complications and modes of failure associated with these devices is limited. Post-marketing surveillance data from the FDA MAUDE database, for the ProGlide system and for the Prostar XL system, were analyzed, yielding 827 Perclose ProGlide reports and 175 Prostar XL reports. Of the 827 reports of major complications involving the Perclose ProGlide devices, 404 reports involved injury, and one involved death related to the device. In the Prostar XL analysis, 94 reports involved injury, and one involved death. Bleeding from vessel injury was the most common adverse outcome described with both devices, followed by hematoma and thrombus. Surgical repair was the most commonly used treatment strategy. In terms of device malfunction, suture-related malfunction (212 reports) was most commonly seen in the Perclose ProGlide group, while failed deployment was most commonly seen in the Prostar XL group. Our analysis of the MAUDE database demonstrates that in real-world practice, suture-based VCDs were found to be associated with complications, including vascular injury, difficulties with the device itself, and even death. Ongoing user education and pre-procedural patient selection are important to minimize risks associated with suture-based vascular closure devices.