Closure Of Femoral Access Sites Research Articles

Sheath Size Up and Down With Single Proglide – A Technique for Achieving Hemostasis With Use of Large Size Delivery System During Endovascular Graft Placement

A total percutaneous approach for management of aortic pathologies with endovascular grafts requires the use of large size delivery-systems. The diameter of these delivery systems usually exceeds the recommended sizes for most of the currently available percutaneous closure devices. A safe, effective and simple vascular access site closure device is desirable for success for percutaneous procedures for aortic pathologies. Hence, we aim to study safety and effectiveness of the use of a single suture based vascular access closure device (ProGlide) using a technique involving serial up and downsizing of the sheath size to achieve access site hemostasis in patients undergoing endovascular graft placement using femoral artery approach. We studied all consecutive patients who underwent endovascular grafting from January 2018 to December 2019. It is a retrospective observational study comparing procedural and short-term outcomes between single ProGlide use and surgical cut-down for femoral access site closure. We excluded patients with femoral artery minimal luminal diameter less than 5 mm, the presence of an aneurysm of the femoral artery, ≥180 degrees of calcium present at femoral/ external iliac artery and history of any vascular closure device use in the last six months. We included 30 patients in single ProGlide group and 30 patients in the surgical cut-down group. One-third of the procedures were urgent procedures in the single Proglide group. Single ProGlide was successful in 93.34% patients and failure (6.66%) was seen due to hematoma and pseudoaneurysm in one patient each detected before discharge. The primary end-point defined by the success of procedure did not differ between the two groups. There were higher complications in the surgical group till 30 days as evidenced by infection, hematoma and neuronal injury. The secondary end-point, defined by the composite of complication events after discharge till 30 days was significantly higher in the surgical group (P-0.005) CONCLUSION: In patients with suitable femoral artery anatomy who undergo endovascular graft placement, effective hemostasis can be achieved safely using up and downsizing of the sheath with a single suture-based technique (Proglide). The results of the study could be considered hypothesis generating and needs to be confirmed in a randomized controlled trial before being adopted in clinical practice.

Femoral access site closure without prior femoral angiography : Aretrospective analysis.

SummaryAims and backgroundAlthough guideline recommendations have shifted towards a transradial route, femoral puncture is still an established vascular access, especially for complex coronary interventions. The FemoSeal™ vascular closure device (FVCD) helps to reduce femoral compression time and access site complications after removal of the catheter sheath. To ensure safe use, an angiography of the femoral artery prior to FVCD deployment is recommended by the manufacturer. We postulate that omitting this angiography does not relevantly increase the risk for vascular complications.Methods and resultsIn this retrospective analysis of an all-comers population (n = 1923) including patients receiving a percutaneous coronary intervention (PCI), we could show that combined vascular complication rates without femoral angiography were low (primary endpoint 4.6%) and comparable to a randomized clinical trial that did perform angiography of the vascular access site in a cohort of patients receiving diagnostic coronary angiography only. In addition to this analysis, we could demonstrate that patients with an acute coronary syndrome, receiving periprocedural anticoagulation or anti-platelet therapy had an increased risk for the formation of arterial pseudoaneurysms; however, we did not observe any ischemic vascular event after FVCD deployment.ConclusionClosure of the femoral access site after coronary angiography using the FVCD can be safely performed without femoral angiography; however, due to an increased risk for the formation of pseudoaneurysms we recommend the transradial access in situations with increased bleeding risk.

TCT-360 Impact of suture mediated femoral access site closure with the Prostar XL compared to the ProGlide system on outcome in transfemoral aortic valve implantation

TCT-360 Impact of suture mediated femoral access site closure with the Prostar XL compared to the ProGlide system on outcome in transfemoral aortic valve implantation

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.

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.

The StarClose® vascular closure system: Interventional results from the CLIP study

The StarClose Vascular Closure System is a femoral access site closure technology that uses a flexible nitinol clip to complete a circumferential, extravascular arteriotomy close. The Clip CLosure In Percutaneous Procedures study was initiated to study the safety and efficacy of the StarClose device in subjects undergoing diagnostic and interventional catheterization procedures. A total of 17 U.S. sites enrolled 596 subjects, with 483 subjects randomized at a 2:1 ratio to receive StarClose or standard compression of the arteriotomy after the percutaneous procedure. The study included roll-in (n = 113), diagnostic (n = 208), and interventional (n = 275) arms with a primary safety endpoint of major vascular complications through 30 days and a primary efficacy endpoint of postprocedure time to hemostasis. The results of the diagnostic StarClose cohort have been reported separately. Results for the interventional arm revealed major vascular complications occurring in 1.1% of StarClose subjects (2/184) and 1.1% in manual compression subjects (1/91; P = 1.00). No infections were seen in either cohort. Minor complications in the StarClose interventional group occurred at a rate of 4.3% (8/184) and with compression at 9.9% (9/91; P = 0.107). Pseudoaneurysm or arteriovenous fistula was not seen with StarClose. With StarClose, procedural success was 100% (136/136) for the diagnostic group and 98.9% (181/183) in the interventional group. Device success for the treatment group was 86.8%. In the interventional cohort, 87.3% (158/181) of StarClose subjects reported a pain scale of 0-3 compared with 93.3% (84/90) in the compression group, which was not statistically different. The clinical results of this study demonstrate that the StarClose Vascular Closure System is noninferior to manual compression with respect to the primary safety endpoint of major vascular events in subjects who undergo percutaneous interventional procedures. StarClose significantly reduced time to hemostasis, ambulation, and dischargeability when compared with compression.

Patient tolerance and resource utilization associated with an arterial closure versus an external compression device after percutaneous coronary intervention

We assessed patient tolerance and resource utilization of using the AngioSeal closure device versus assisted manual compression using the Femostop device after percutaneous coronary intervention (PCI). Patients undergoing PCI with clean arterial access and no procedural hematoma were randomized to receive the AngioSeal or Femostop device to achieve femoral arterial hemostasis. Times from procedure end to removal from angiography table, hemostasis, ambulation, and hospital discharge were recorded. Bedside nursing/medical officer care time, vascular complications, and disposable use were also documented. Patient comfort was assessed using Present Pain Intensity and Visual Analogue scales at baseline, 4 hr, 8 hr, and the morning after the procedure. One hundred twenty-two patients were enrolled (62 AngioSeal, 60 Femostop). Patients in the AngioSeal group took longer to be removed from the angiography table (11 +/- 4 vs. 9 +/- 3 min; P = 0.002) compared with the Femostop group. Time to hemostasis (0.4 +/- 1.1 vs. 6.4 +/- 1.7 hr; P < 0.001) and ambulation (17 +/- 8 vs. 22 +/- 13 hr; P = 0.004) were less in the AngioSeal group, although time to discharge was not different. Nursing and medical officer time was no different. Disposables including device cost were higher in the AngioSeal group (209 dollars +/- 13 vs. 53 dollars +/- 9; P < 0.001). On a Visual Analogue scale, patients reported more pain at 4 hr (P < 0.001) and 8 hr (P < 0.001) in the Femostop group. The worst amount of pain at any time point was also more severe in the Femostop group (P < 0.001). Similar results were found on a Present Pain Intensity scale of pain. There were no differences in ultrasound-determined vascular complications (two each). Femoral access site closure using the AngioSeal device resulted in a small delay in leaving the angiography suite and a higher disposable cost compared to using the Femostop device. However, patients receiving the AngioSeal were able to ambulate sooner and reported less pain, which may justify the increased costs involved.

Use of the percutaneous vascular surgery device for closure of femoral access sites during endovascular aneurysm repair: lessons from our experience.

to evaluate the results of our early experience with a percutaneous closure device for aortic aneurysm repair and to identify device related and patient related factors leading to procedure failure. eighty-two percutaneous closures in forty-four patients was performed using the 10F Prostar XL Percutaneous Vascular Surgery device during the repair of 1 iliac, 1 thoracic and 42 abdominal aortic aneurysms. successful closure was achieved in 70 access sites (85%) with 12 sites requiring conversion to an open groin incision. The reasons for failure include difficult device introduction due to a tortuous iliac, deflection of needles due to previous scar, femoral artery occlusion and failure of the device to close the arteriotomy. There was one intraoperative death from retroperitoneal haemorrhage and another patient developed a pseudoaneurysm at the cannulation site. use of the percutaneous closure device requires very careful patient selection. Preoperative radiological assessment of the ilio-femoral vessels is vital to assess for cacification and tortuosity. High device failure rates can be expected from obese patients and those with scarred groins. When difficulty is encountered during the procedure, there should be a low threshold for conversion to an open groin incision. The device and the method of introduction can be further improved to address some of these issues.