Suture-based Vascular Closure Devices Research Articles

Pledget reinforcement and traction compression as adjunctive techniques for suture-based closure of arterial cannulation sites in percutaneous endovascular aneurysm repair-initial experience.

Suture-based vascular closure devices are used in percutaneous endovascular procedures. However, failures are not uncommon. We have described our initial experience with two adjunct techniques to reinforce the suture-based vascular closure device (ProGlide; Abbot Vascular, Santa Clara, Calif) after percutaneous endovascular aneurysm repair. The threads of the ProGlide device (Abbot Vascular) were passed through a pledget with the help of a needle, which was secured to the puncture site to allow for traction compression. The use of the techniques can be helpful if the suture-based vascular closure devices fail to achieve immediate and complete hemostasis. The use of these adjuncts could reduce the incidence of closure-related complications after percutaneous endovascular procedures.

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.

Assessment of the MANTA closure device in transfemoral transcatheter aortic valve replacement: a single-centre observational study

ObjectivesThe present study aims to evaluate the efficacy and safety of the MANTA vascular closure device (VCD) (Teleflex, Morrisville, NC, USA) in transfemoral transcatheter aortic valve replacement (TF-TAVR).BackgroundTo close the femoral artery in TF-TAVR a VCD is the treatment of choice. Data involving suture-based VCDs have been extensive. Although scarce, results on the MANTA device are promising. There is no consensus yet as to whether the MANTA device is associated with fewer access-site-related vascular/bleeding complications when compared to suture-based VCDs.MethodsIn this prospective single-arm study, performed at a single centre, a total of 73 patients eligible for TF-TAVR were included and consecutively treated with the MANTA device.ResultsAccess-site-related vascular complications were seen in 13.7% of patients treated with the MANTA device. In this group of patients only minor vascular complications were observed. Access-site-related bleeding complications were rare (6.8%), and device failure was seen in 13.7% of the patients.ConclusionsThis single-centre study confirms that use of the MANTA device in TF-TAVR is feasible with an acceptable rate of access-site-related complications and no major vascular complications.

Transfemoral Approach for Coronary Angiography and Intervention: A Collaboration of International Cardiovascular Societies

ObjectivesThe aim of this study was to examine the current practice and use of transfemoral approach (TFA) for coronary angiography and intervention. BackgroundWide variability exists in TFA techniques for coronary procedures. MethodsThe authors developed a survey instrument that was distributed via e-mail lists from professional societies to interventional cardiologists from 88 countries between March and December 2016. ResultsOf 987 operators, 18% were femoralists, 38% radialists, 42% both, and 2% neither. Access using femoral pulse palpation alone was preferred by 60% of operators, fluoroscopy guidance by 11%, and a combination of palpation, fluoroscopy, or ultrasound by 27%. Only 11% used micropuncture in >90% of their cases. Performing femoral angiography immediately after access was preferred by 23% and at the end of the procedure by 47%, and not done at all by 31% of operators. Hemostasis by manual compression was preferred by 50%, collagen plug vascular closure device by 31%, and suture-based vascular closure device by 11% of operators. Judkins left and right catheters were preferred for diagnostic angiography of the left (99%) and right (94%) coronary arteries. Extra backup curves (XB or EBU) were most commonly preferred for percutaneous coronary intervention of the left anterior descending (80%) and left circumflex (80%), whereas the Judkins right catheter was preferred for percutaneous coronary intervention of the right coronary artery (86%). ConclusionsThere is significant variability in preferences for femoral access technique. Even though recommended best practices advocate for fluoroscopic and ultrasound guidance, most operators use palpation alone. Femoral angiography is also not consistently used despite guideline recommendations. The lack of adoption of imaging guidance for vascular access deserves further investigation.

Impact of suture mediated femoral access site closure with the Prostar XL compared to the ProGlide system on outcome in transfemoral aortic valve implantation

BackgroundManagement of femoral access site is an important issue in transfemoral transcatheter aortic valve implantation (TAVI) and crucial for acute and long-term outcome. Data on vascular closure devices in this setting are limited. We evaluated safety and efficacy of the Prostar XL compared to the ProGlide suture-based vascular closure device. Methods and resultsWe enrolled 585 patients undergoing percutaneous transfemoral transcatheter aortic valve implantation (TAVI). Outcomes were defined according to Valve academic research consortium (VARC)-2 criteria. In 237 (40.5%) patients femoral access site closure was performed using the Prostar and in 348 patients (59.6%) using the ProGlide vascular closure device. There was no significant difference in patient baseline characteristics including single and dual antiplatelet therapies. Sheath outer diameter was significantly larger in the ProGlide compared with the Prostar group (7.7±1.5 vs. 7.9±0.5mm; p=0.001). Closure device failure according to VARC-2 criteria was significantly more frequent with the Prostar versus ProGlide device (19% vs. 4.6%; p<0.01). Need for surgical repair (11.8% vs. 0%, p<0.01), major (12.2% vs. 2.3%, p<0.01) and minor (17.3% vs. 5.7%, p<0.01) vascular complications and bleeding complications (5.5% vs. 2.0%, p=0.02) occurred significantly more often with the Prostar device compared with the ProGlide system. In addition, in-hospital mortality was higher with Prostar compared with ProGlide (5.9% vs. 2.0%; p=0.01). ConclusionFemoral access site closure with the ProGlide device compared with the Prostar device in transfemoral aortic valve implantation was associated with significantly lower rates of closure device failure, minor and major bleedings and a significantly lower in-hospital mortality.Clinical Trial Registration:clinicaltrials.govNCT02162069.

Vascular closure devices for femoral arterial puncture site haemostasis.

Vascular closure devices for femoral arterial puncture site haemostasis.

Vascular Closure Device Failure in Contemporary Practice

The goal of this study was to assess the frequency and predictors of vascular closure device (VCD) deployment failure, and its association with vascular complications of 3 commonly used VCDs. VCDs are commonly used following percutaneous coronary intervention on the basis of studies demonstrating reduced time to ambulation, increased patient comfort, and possible reduction in vascular complications as compared with manual compression. However, limited data are available on the frequency and predictors of VCD failure, and the association of deployment failure with vascular complications. From a de-identified dataset provided by Massachusetts Department of Health, 23,813 consecutive interventional coronary procedures that used either a collagen plug-based (n = 18,533), a nitinol clip-based (n = 2,284), or a suture-based (n = 2,996) VCD between June 2005 and December 2007 were identified. The authors defined VCD failure as unsuccessful deployment or failure to achieve immediate access site hemostasis. Among 23,813 procedures, the VCD failed in 781 (3.3%) procedures (2.1% of collagen plug-based, 6.1% of suture-based, 9.5% of nitinol clip-based VCDs). Patients with VCD failure had an excess risk of "any" (7.7% vs. 2.8%; p < 0.001), major (3.3% vs. 0.8%; p < 0.001), or minor (5.8% vs. 2.1%; p < 0.001) vascular complications compared with successful VCD deployment. In a propensity score-adjusted analysis, when compared with collagen plug-based VCD (reference odds ratio [OR] = 1.0), nitinol clip-based VCD had 2-fold increased risk (OR: 2.0, 95% confidence interval [CI]: 1.8 to 2.3, p < 0.001) and suture-based VCD had 1.25-fold increased risk (OR: 1.25, 95% CI: 1.2 to 1.3, p < 0.001) for VCD failure. VCD failure was a significant predictor of subsequent vascular complications for both collagen plug-based VCD and nitinol clip-based VCD, but not for suture-based VCD. VCD failure rates vary depending upon the type of VCD used and are associated with significantly higher vascular complications as compared with deployment successes.

A new kaolin-based hemostatic bandage use after coronary diagnostic and interventional procedures

BackgroundBleeding and vascular access site complications are an important cause of morbidity after percutaneous femoral procedures. Together with collagen-based and suture-based vascular closure devices, new hemostatic dressings have been developed to control heavy bleeding. Aim of studyTo evaluate safety and efficacy results of the first clinical QuikClot Interventional Hemostatic Bandage use for femoral artery closure after diagnostic or interventional procedures. MethodsThe first European safety study was performed at the Centro Cardiologico Monzino in Milan, Italy, on January 2010. Forty consecutive patients (75% male, mean age 68±11years) undergoing diagnostic angiography (62%) or PCI (38%) by femoral approach with a 6- (90%) or 7-Fr (10%) size introducer, received arterial sheath removal with the QuikClot Interventional gauze use. The mean ACT value at hemostasis time was 138±24s (range 95–186s). Hemostasis was achieved in a mean time of 4.9±0.5min. Only one hemostasis failure occurred requiring prolonged mechanical compression. Neither major bleeding, re-bleeding nor hematoma occurred after early (4h after procedure) ambulation. ConclusionsQuikClot Interventional Bandage obtained prompt hemostasis and allowed for an early ambulation without clinical complications.

Inadvertent Femoral Endarterectomy: A Complication from a Suture-based Vascular Closure Device

Inadvertent Femoral Endarterectomy: A Complication from a Suture-based Vascular Closure Device

Randomized comparison of effects of suture-based and collagen-based vascular closure devices on post-procedural leg perfusion

Vascular closure devices (VCD) are well established to facilitate hemostasis after cardiac catheterization procedures. However, impairment of flow due to the reduction of femoral artery diameter remains a major concern. The present study aims to evaluate leg perfusion before and after application of collagen- and suture-based vascular closure devices. A total of 366 patients (age: 64.3 years+/-10.7, male: 71.3%) were randomized to receive femoral access site closure with either a collagen-based closure device (group A) (n=214) or a suture-mediated device (group B) (n=152), immediately following coronary catheterization procedures. In all patients, the ankle-brachial-index (ABI) was measured before and the day after closure device application. In group A, mean ABI at baseline was 1.09+/-0.2, in group B 1.11+/-0.2. In both groups, there was a significant, albeit clinically not relevant, reduction in post-procedural ABI (group A: 1.04+/-0.2, p<0.01 vs baseline, group B: 1.06+/-0.2, p<0.01 vs baseline). DeltaABI was not different between both VCD groups (p=0.55). In patients with peripheral vascular disease (PVD), neither the Angioseal device (mean ABI at baseline 0.76+/-0.1) nor the Perclose-device (mean ABI at baseline 0.79+/-0.1) induced a remarkable impairment of leg perfusion (Angioseal: 0.77+/-0.1, p=0.9 vs baseline, Perclose: 0.78+/-0.1, p=1.0 vs baseline). Clinically, no aggravation of claudication was observed in the PVD patient group. Both vascular closure devices are not associated with clinically relevant reduction in ABI. There was no difference between the two groups with respect to the level of flow impairment. Both devices may be safely used in patients with reduced ABI.

Th-P17:440 Plasma and urine sample preparation using multidimensional solid-phase extraction for analysis of F2 isoprostanes by LC-MS/MS

Bleeding and vascular access site complications are an important cause of morbidity after percutaneous femoral procedures. Together with collagen-based and suture-based vascular closure devices, new hemostatic dressings have been developed to control heavy bleeding.To evaluate safety and efficacy results of the first clinical QuikClot Interventional Hemostatic Bandage use for femoral artery closure after diagnostic or interventional procedures.The first European safety study was performed at the Centro Cardiologico Monzino in Milan, Italy, on January 2010. Forty consecutive patients (75% male, mean age 68 ± 11 years) undergoing diagnostic angiography (62%) or PCI (38%) by femoral approach with a 6- (90%) or 7-Fr (10%) size introducer, received arterial sheath removal with the QuikClot Interventional gauze use. The mean ACT value at hemostasis time was 138 ± 24 s (range 95–186 s). Hemostasis was achieved in a mean time of 4.9 ± 0.5 min. Only one hemostasis failure occurred requiring prolonged mechanical compression. Neither major bleeding, re-bleeding nor hematoma occurred after early (4 h after procedure) ambulation.QuikClot Interventional Bandage obtained prompt hemostasis and allowed for an early ambulation without clinical complications.

Th-P17:438 Folate receptors and proteomic analysis of endothelial cells in atherosclerosis

Bleeding and vascular access site complications are an important cause of morbidity after percutaneous femoral procedures. Together with collagen-based and suture-based vascular closure devices, new hemostatic dressings have been developed to control heavy bleeding.To evaluate safety and efficacy results of the first clinical QuikClot Interventional Hemostatic Bandage use for femoral artery closure after diagnostic or interventional procedures.The first European safety study was performed at the Centro Cardiologico Monzino in Milan, Italy, on January 2010. Forty consecutive patients (75% male, mean age 68 ± 11 years) undergoing diagnostic angiography (62%) or PCI (38%) by femoral approach with a 6- (90%) or 7-Fr (10%) size introducer, received arterial sheath removal with the QuikClot Interventional gauze use. The mean ACT value at hemostasis time was 138 ± 24 s (range 95–186 s). Hemostasis was achieved in a mean time of 4.9 ± 0.5 min. Only one hemostasis failure occurred requiring prolonged mechanical compression. Neither major bleeding, re-bleeding nor hematoma occurred after early (4 h after procedure) ambulation.QuikClot Interventional Bandage obtained prompt hemostasis and allowed for an early ambulation without clinical complications.