Suture-based Closure Devices Research Articles

Femoral Arterial Calcification and Plug- vs. Suture-Based Closure Device Strategies Post-Transcatheter Aortic Valve Implantation: Insights From CHOICE-CLOSURE

BackgroundThe location and severity of vascular calcification may influence closure device success in transfemoral transcatheter aortic valve implantation. The aim of this study was to analyze effects of vascular access-site calcification on vascular and bleeding outcomes post-transcatheter aortic valve implantation. MethodsThe Randomized Comparison of CatHeter-based Strategies fOr Interventional ACcess SitE CLOSURE during Transfemoral Transcatheter Aortic Valve Implantation (CHOICE-CLOSURE) trial assigned 516 patients to access site closure using a pure plug-based technique (MANTA, Teleflex) or a primary suture-based technique (ProGlide, Abbott Vascular). The principal finding of the overall study was that access-site or access-related complications were more common after the plug-based strategy compared to percutaneous closure with a suture-based strategy. In this predefined subgroup analysis, the overall cohort was split into patients with and without anterior calcification at the access site and divided by degree of calcification severity using the classification system developed in the MANTA vs. suture-based vascular closure after transcatHeter aortic valve replacement (MASH) trial. Differences in bleeding and vascular complications were compared. The primary endpoint consisted of access-site- or access-related major and minor vascular complications. ResultsThere were more access-site-related major and minor vascular complications for patients with anterior wall vascular calcification and MASH severe calcification. No significant interaction with choice of closure technique in terms of access-site-related major and minor vascular complications was observed (odds ratio 1.70, 95% CI 0.77-3.78, p = 0.19 for the primary endpoint in plug- vs. suture-based strategy in patients with anterior calcification, odds ratio 1.78, 95% CI 0.56-5.65, p = 0.33 for primary endpoint in plug- vs. suture-based strategy with MASH severe calcification, pint = 0.97 for anterior calcification, pint = 0.95 for MASH severe calcification). ConclusionsThe total number of vascular complications was found to be greater in the presence of anterior and MASH severe calcification. Overall, the presence of anterior or severe calcification does not significantly modify the efficacy of the suture-based strategy compared to the plug-based strategy.

Vascular Complications in Transcatheter Aortic Valve Replacement With Plug-Based vs Suture-Based Closure Devices.

There are conflicting data regarding the efficacy and safety of suture vs plug-based vascular closure devices (VCDs) for large-bore catheter management in patients undergoing transcatheter aortic valve replacement (TAVR). We compared the rates of vascular complications (VCs) associated with 2 commonly used VCDs in a large cohort of patients undergoing TAVR. We conducted a single-centre, all-comer, prospective registry study, enrolling patients undergoing TAVR for symptomatic severe aortic stenosis (AS) between the years 2009 and 2022. Clinical outcomes were compared between patients undergoing closure of the femoral access point using the MANTA VCD (M-VCD) (Teleflex, Wayne, PA) vs the ProGlide VCD (P-VCD) (Abbott Vascular, Abbott Park, IL). The main outcome measures were researcher adjudicated events of VARC-2 defined major and minor VCs. Overall, 2368 patients were enrolled in the registry; 1315 (51.0% male, 81.0 ± 7.0 years) patients were included in the current analysis. P-VCD was used in 813 patients, whereas M-VCD was used in 502 patients. In-hospital VCs were more frequent in the M-VCD vs the P-VCD group (17.3% vs 9.8%; P < 0.001). This outcome was mainly driven by elevated rates of minor VCs in the M-VCD group, whereas no significant difference was observed for major VCs (15.1% vs 8.4%; P < 0.001 and 2.2% vs 1.5%; P= 0.33, respectively). In patients undergoing TAVR for severe AS, M-VCD was associated with higher rates of VCs. This outcome was mainly driven by minor VCs. The rate of major VCs was low in both groups.

1050 ULTRASOUND GUIDED CANNULATION OF FEMORAL ARTERY IN PATIENTS UNDERGOING TRANSCATHETER AORTIC VALVE REPLACEMENT

Abstract Background Vascular access complications are a significant source of morbidity and mortality after transcatheter aortic valve replacement (TAVR). Ultrasound-guided cannulation (UGC) of central veins or arteries is a widely used approach for patients undergoing invasive procedures. Whether UGC significantly decreases the risk of vascular access complications also for large-bore access procedures, such as TAVR, lacks evidence Objectives in this study, we aimed to evaluate the benefits of routine use of UGC in patients undergoing TAVR. Methods Data were retrospectively collected from two high-volume TAVR centers from September 2009 to March 2022. UGC was performed using a two-dimensional ultrasound short-axis views, while manual palpation, fluoroscopy, or contralateral angiography were used for the other patients. 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 (forward stepwise selection process). Vascular complications were adjudicated according to the Valve Academic Research Consortium definitions 3. Results Out of 874 patients included in the study, UGC access was performed in 177 subjects. Overall mean age was 80.2±5.8 years old, 60% of patients were females, 35.5% had diabetes, 61.4% had dyslipidemia, and 27.8% had chronic kidney disease, with a mean left ventricular ejection fraction of 52.7±9.7%. Looking at the procedural variables Euroscore II was 5.8±5.4, second and third valves generation have been used in 85% of the cases, while suture-based closure devices in 84% of subjects. After adjustment for clinical and procedural variables, routinely use of UGC was associated with a lower rate of total [Odds Ratio (OR): 0.38; 95% confidence interval (CI) 0.15% to 0.95%)] and major vascular complications [Odds Ratio (OR): 0.21; 95% confidence interval (CI) 0.05% to 0.75%)], while no differences were observed for minor vascular complications. Conclusions Routinely use of UGC significantly decreases the risk of vascular complications in patients undergoing TAVR. However, a dedicated randomized clinical trial assessing the safety and efficacy of this approach is warranted to confirm our results in this high-risk population.

Suture-based vs. pure plug-based vascular closure devices for VA-ECMO decannulation

Abstract Background VA-ECMO is a valuable treatment option for patients in cardiogenic shock, but complications during decannulation may worsen the overall outcome. To date, no larger study has ever compared suture-based to pure plug-based vessel closure devices for VA-ECMO decannulation. Purpose The aim of the study was to compare the efficacy and safety of suture-based to pure plug-based vascular closure devices for veno-arterial extracorporeal membrane oxygenation (VA-ECMO) decannulation for patients with cardiogenic shock. Methods In this retrospective study, the outcome of 33 patients with suture-based closure devices implanted between 02/2019 to 05/2020 were compared to 38 patients with plug-based closured device implanted between 06/2020 to 11/2021. Results Closure device success rate was 88% in the suture-based group versus 97% in the plug-based group (Figure 1, p=0.27). Median number of devices used was two for patients with suture-based closure device and 1 for patients with plug-based closure device (p&amp;lt;0.01). Severe bleeding was more frequent in the suture-based (21%) compared to the plug-based group (3%) (Figure 2, p=0.04). Ischemic complications occurred in 6% with suture-based and 5% with plug-based device (p=1.00). Pseudoaneurysm formation was detected in 3% in both groups (p=1.00). Application of the femoral compression system was required in 27% of patient with suture-based closure device and 11% of patients with plug-based closure device (p=0.13). No switch to open vascular surgery due to closure device failure occurred in both groups. Conclusions Based on our retrospective analysis, we propose that plug-based vascular closure should be the preferred option for VA-ECMO decannulation. This hypothesis should be further tested in a randomized trial. Funding Acknowledgement Type of funding sources: Public grant(s) – National budget only. Main funding source(s): Deutsche Forschungsgemeinschaft

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

Vascular 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. We 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. Eleven 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. Plug-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.

Clinical Outcomes of MANTA vs Suture-Based Closure Devices After TAVR: An Updated Meta-Analysis

Clinical Outcomes of MANTA vs Suture-Based Closure Devices After TAVR: An Updated Meta-Analysis

Plug-Based Versus Suture-Based Closure Devices for Large-Bore Arteriotomy – An Updated Meta-Analysis

Plug-Based Versus Suture-Based Closure Devices for Large-Bore Arteriotomy – An Updated Meta-Analysis

Simple option for large access vascular closure in case of failed suture-based closure device after TAVI

Simple option for large access vascular closure in case of failed suture-based closure device after TAVI

CRT-700.28 Clinical Outcomes of MANTA vs Suture-Based Closure Devices After TAVR: An Updated Meta-Analysis

CRT-700.28 Clinical Outcomes of MANTA vs Suture-Based Closure Devices After TAVR: An Updated Meta-Analysis

CRT-700.67 Plug-Based Versus Suture-Based Closure Devices for Large-Bore Arteriotomy – An Updated Meta-Analysis

CRT-700.67 Plug-Based Versus Suture-Based Closure Devices for Large-Bore Arteriotomy – An Updated Meta-Analysis

Single versus double use of a suture-based closure device for transfemoral aortic valve implantation

BackgroundThe most common method of percutaneous closure in transfemoral transcatheter aortic valve implantation (TAVI) employs two obtusely oriented ProGlide devices. The aim of this study was to assess the feasibility and safety of using a single ProGlide system for primary access site closure in comparison with the double ProGlide approach in an all-comers TAVI population. MethodsBetween March 2016 and December 2018, a total of 1105 patients underwent transfemoral TAVI for severe aortic stenosis at our center. Application of two ProGlide systems was standard until April 2017 (n = 432), whereas thereafter a single ProGlide system was used (n = 663). A 1:1 propensity score matching was performed to adjust for baseline differences between the two groups, resulting in 327 matched cases. Primary outcomes of interest were main access site-related vascular complications. ResultsThe mean number of ProGlide devices used per patient was 1.03 (SD 0.2) in the single-ProGlide group versus 2.01 (SD 0.14) in the double-ProGlide group. An additional vascular closure device was required to obtain full hemostasis in 23.2% versus 9.5% of patients (p < 0.001) in the two groups, respectively. Technical success of ProGlide usage was similar (94.3% versus 92.1%, p = 0.163). In the matched cohorts, the rates of main access site-related major vascular complications were similar (4.0% vs. 6.4%, p = 0.217). ConclusionThe single-ProGlide technique is feasible, with rates of technical success similar to those of the double-ProGlide technique. Use of this method did not lead to more frequent access site-related complications but was more cost effective than the double-ProGlide approach.

TCT CONNECT-293 Real-World Experience of Suture-Based Closure Devices: Insights From the FDA Manufacturer and User Facility Device Experience (MAUDE) Database

TCT CONNECT-293 Real-World Experience of Suture-Based Closure Devices: Insights From the FDA Manufacturer and User Facility Device Experience (MAUDE) Database

868 “Post-Close” Technique for Large Calibre Vascular Access

The modified “Preclosure” technique for immediate vascular access site closure described by Kahlert et al is well established and remains the mainstay for management of large calibre arterial access site. However, it involves the predeployment of three suture-based closure devices (most commonly the Perclose device) immediately after establishing access prior to dilatation for sheath insertion. When large calibre percutaneous femoral artery access is required in a time critical circumstance, it would be ideal to minimise time spent securing arterial access. We describe a case where percutaneous aortic valve replacement via transapical approach had to be converted to transfemoral approach intraoperatively, necessitating swift establishment of arterial access allowing insertion of a 14 French sheath with a dynamic expansion mechanism. Our novel “post-close” technique was successful in achieving large calibre vascular access site closure with excellent haemostasis without pre-deployment of Perclose devices. Firstly, manual pressure is applied proximal to the arterial puncture site. The large caliber sheath is then removed with simultaneous manual compression at the site of arterial puncture. Two Perclose devices were then deployed in the conventional manner, with further manual compression over the vessel subsequently. There were no vascular complications. This “post-close” technique would be particularly useful in emergency settings such as for portable haemodynamic devices and newer mechanical support devices like Impella (ABIOMED) where the “Preclose” technique has also been shown to be useful. Further studies with a larger sample are required to evaluate its safety and efficacy.

A new Percutaneous technique for effective vascular Access Site closure in patients undergoing Transfemoral aortic valve implantation and thoraco-abdominal aortic aneurysm rEpair: the PASTE study.

The success of transfemoral transcatheter aortic valve implantation (TAVI) and thoraco-abdominal aneurysm repair (TAAR) depends on haemostatic control of the access site, which is usually obtained with suture-based closure devices (Prostar or two ProGlide). A single ProGlide/Glubran technique, involving a suture placement on the vessel wall followed by tissue glue injection around the vessel wall, has not been previously investigated in this clinical setting. Our aim was to study the feasibility and safety of a single ProGlide/Glubran technique for vascular access-site closure after transfemoral TAVI and TAAR. This technique was used in 250 patients from 2012 to 2017. The primary endpoint was the success of the technique, defined as access-site haemostasis without complications and not requiring any additional intervention within 30 days of the index procedure. Patients had a mean age of 82.4±1.93 years, with a logistic EuroSCORE of 20.2±2.32. A total of 218 TAVI and 32 TAAR procedures were performed with a mean sheath size of 18.09±1.55 Fr. The mean sheath to femoral artery ratio was 1.04±0.16, with mean femoral artery minimal lumen diameter 6.65±0.64 mm. The overall success rate of this technique was 98.4%. Four patients (1.6%) developed critical stenosis of the femoral artery requiring balloon dilatation. No major VARC-2 vascular complications were observed. Thirty-day mortality was 0.4% (non-cardiovascular). The results of this study suggest that the single ProGlide/Glubran technique is a safe and effective method of closing the arterial access site after transfemoral TAVI and TAAR. The results of our study need to be confirmed in a randomised controlled trial before being adopted in routine clinical practice.

Impact of femoral artery puncture using digital subtraction angiography and road mapping on vascular and bleeding complications after transfemoral transcatheter aortic valve implantation.

The use of large-diameter sheaths carries the risk of significant vascular and bleeding complications after transfemoral transcatheter aortic valve implantation (TAVI). In this analysis, we sought to assess the impact of a modified femoral artery puncture technique using digital subtraction angiography (DSA) and road mapping during transfemoral TAVI on periprocedural vascular and bleeding events. This is a retrospective analysis of transfemoral TAVI patients included in a prospective institutional database. The modified femoral artery puncture technique using DSA-derived road mapping guidance was introduced in October 2012. Before the introduction of this technique, vascular puncture was acquired based on an integration of angiographic data, the bony iliofemoral landmarks and a radiopaque object. Consecutive patients who underwent TAVI with the road mapping technique (RM group, n=160) were compared with consecutive patients who underwent TAVI without road mapping (control group, n=160) prior to its introduction. A standardised strategy of periprocedural anticoagulation was adopted in both groups as well as the use of a single suture-based closure device. All endpoints were defined according to the VARC-2 criteria for event definition. The mean age in the RM group was 80±7.7 years compared to 81±5.9 years in the control group (p=0.19), and females were equally distributed between both groups (63.1% vs. 58.1%, p=0.36). The baseline logistic EuroSCORE was 20.7±14.4% vs. 24.9±15.2% in the RM and control group, respectively (p=0.01). Notably, sheath size was significantly larger in the RM compared to the control group due to the more frequent use of the 20 Fr sheath (23.8% vs. 1.8%, p<0.001, respectively) associated with the more frequent implantation of the 29 mm Edwards SAPIEN XT valve in the RM group (43.8% vs. 7%, respectively, p<0.001). Despite the latter finding, both major vascular complications and major bleeding at 30 days were significantly lower in the RM group compared to the control group (4.3% vs. 11.8%, p=0.01, and 14.4% vs. 25.6%, p=0.01). An analysis limited to access site-related complications also revealed lower events in the road map group but did not reach statistical significance (8.1% vs. 13.8%, p=0.1). Other forms of vascular and bleeding complications as well as all-cause mortality were comparable in both groups. A modified femoral artery puncture technique using DSA and road mapping was associated with a reduction in major vascular and bleeding complications after transfemoral TAVI, and provides a simple and effective strategy for potentially improving patient outcomes.

Percutaneous Suture-Based Closure Device for Management of Inadvertent Subclavian Artery Catheterization

Central venous catheterization is performed to secure pathways for large amounts of saline, drug infusion, parenteral nutrition support, and hemodialysis. Accidental subclavian artery cannulation is a possible complication of central venous catheterization. Here, we report two cases of 8 Fr. chemoports inadvertently inserted in subclavian arteries during internal jugular venous catheterizations. The chemoports were removed successfully, and puncture sites were repaired using suture-based closure devices (Perclose). One patient experienced minor neurological complications after the procedure. With effective management, the patient was treated with no sequelae. To our knowledge, this is the first report of stroke after procedures using suture-based devices. (Korean J Med 2014;87:200-204)

Abstract 19521: Impact of Procedural Complications on Survival in Patients with Severe Aortic Stenosis Treated with Balloon Aortic Valvuloplasty: Results from the BRAVO Study

Introduction. Previous studies have examined the baseline predictors of survival in patients with severe aortic stenosis treated with balloon aortic valvuloplasty (BAV). However, the impact of procedural complications on long-term survival is unknown. Methods. Weconducted an independent retrospective review of pts who underwent non-emergent BAV at 2 high volume centers from 2005 to 2011. In-hospital events (bleeding, vascular complications, acute kidney injury [AKI], myocardial infarction, stroke) were adjudicated by an independent Clinical Events Committee. Survival status of all patients was ascertained by the Social Security Death Index. We compared patient survival by the occurrence of in-hospital complications. Cox regression analysis was used to adjust for significant baseline and procedural correlates of survival, in order to determine the incremental impact of in-hospital events on longer-term survival. Results. The median follow-up duration among 445 patients post BAV was 288 days. Major bleeding (defined as BARC type ≥ 3), AKI and vascular complications (per VARC definitions) were associated with increased mortality. After adjusting for baseline and procedural variables, AKI remained a strong predictor of mortality (OR 6.9, 95% CI 3.7 - 12.6, p&lt;0.001), major bleeding was associated with a trend for increased mortality (OR 1.5, 95% CI 0.96 - 2.5, p=0.07) and vascular complications were eliminated as a predictor. By Cox methods, anemia, atrial fibrillation/flutter and high creatinine at baseline were also associated with mortality whereas rapid RV pacing and attempted “preclosure” of the access site using a suture-based closure device were associated with improved survival (all p&lt;0.05, Figure). Conclusion. Procedural complications, in particular AKI, have significant impact on long term survival after BAV. Dedicated studies are required to examine the impact of strategies to reduce procedural complications on long term patient outcomes.

TCT-493: Closure of Large Percutaneous Access Sites After Balloon Aortic Valvuloplasty Using a Suture Based Closure Device vs. Collagen Based Closure Device vs. Manual Compression

TCT-493: Closure of Large Percutaneous Access Sites After Balloon Aortic Valvuloplasty Using a Suture Based Closure Device vs. Collagen Based Closure Device vs. Manual Compression

Management of arterial puncture site after catheterization procedures: evaluating a suture-mediated closure device

To overcome the challenge associated with achievement in hemostasis after a catheterization procedure, a suture-based closure device was compared with manual compression in a 600-patient randomized trial. The major study end points included the incidence of vascular complications and the time to ambulation after the procedure. The study included diagnostic or interventional procedures. The suture-mediated closure was performed immediately after the procedure independent of the anticoagulation level, whereas manual compression was performed per hospital protocol with sheath removal relying on normalization of patient’s anticoagulation status. A significant reduction in time to achieve hemostasis (7.8 ± 4.8 vs 19.6 ± 13.2 minutes, p <0001) and time to ambulation (4.5 ± 6.5 vs 17.8 ± 5 hours, p <0001) was associated with use of the suture-mediated closure device. The incidence of vascular complications was similar in the overall population (5.7% for suturing device vs 11.3% for compression) or in the interventional patient subset (8.4% for suturing device vs 9.6% for compression). There was a significant reduction in the incidence of vascular complications in the diagnostic procedure subset (4.4% for suturing device vs 12.1% for compression, p <0.05). Thus, the use of a suture-mediated closure device represents a safe alternative to manual compression. Hemostasis and ambulation can be achieved faster with the suturing device than with manual compression, with a potential reduction in access site complications.