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Aim: This study aims to describe the feasibility and safety of direct occluded vessel puncture as a new access site for complex peripheral artery occlusive disease., Methods: Eleven consecutive patients with symptomatic peripheral artery disease underwent endovascular therapy using the direct occluded vessel puncture technique. The occluded vessel was punctured using a dedicated 20 G needle and the Hi-Torque Command 18 ST guidewire under duplex echo or fluoroscopic guidance, and a 6 Fr sheath was then inserted. Hemostasis was achieved with the Exoseal ® Vascular Closure Device., Results: Direct occluded vessel puncture was achieved in 10 of 11 cases (90.9%), and procedural success was achieved in all cases. There were no in-hospital deaths or any complications, including bleeding, pseudoaneurysms, thrombosis, or surgical conversion., Conclusion: The direct occluded vessel puncture technique using a 20 G needle and the Hi-Torque Command 18 ST is feasible and safe. This technique may also be used as an alternative option when there are no appropriate approach sites.

The authors analysed both immediate and remote results of puncture treatment with the use of human thrombin under ultrasound control in patients with iatrogenic false aneurysms of femoral arteries. The study included a total of 32 patients presenting with post-puncture pseudoaneurysms of femoral arteries after previous endovascular manipulations. The clinical diagnosis was verified by means of ultrasound duplex scanning. Puncture treatment was carried out using lyophilisate of human thrombin at a concentration of 500 IU according to the patented technique. The obtained outcomes were assessed at various terms (up to 12 months). The predominant ultrasound characteristics of a false aneurysm were as follows: an arterial defect sized 2.1-3 mm with prevailing localization in the superficial femoral artery (singe-chamber pseudoaneurysm with the volume of its cavity amounting to 31-60 cm 3 ). The average dose of thrombin sufficient for obliteration of the cavity amounted to 320.8±104.6 IU. The puncture treatment proved to be effective in 30 (93.7%) patients. In the remaining 2 (6.3%) cases the outcomes of puncture treatment turned out unsatisfactory, thus requiring an operative intervention. No relapsed were observed in the remote period. A conclusion was drawn that puncture treatment is a highly effective method in relation to false aneurysms of femoral arteries and is neither accompanied by relapses nor followed by allergic, thrombotic, infectious complication at various terms of follow up. Efficacy of treatment with human thrombin does not depend on taking antithrombotic agents by the patients.

Objective: To retrospectively evaluate the efficacy and time-to-hemostasis of antegrade femoral access closure using the ExoSeal vascular closure device (VCD)., Design: Retrospective, single-center analysis., Materials and Methods: Between September 2010 and February 2013, 148 ExoSeal VCD closures (5-7F) of antegrade femoral accesses were performed in 119 patients (70 males, mean age 71.6 years, range 40-97 years). In all cases initial diagnostic angiography was performed via an 18G/3.8F retrograde femoral access, which was left in place during intervention (in-house standard) and was used to obtain control angiography after successful closure of the antegrade access to determine hemostasis. Technical device success was defined as ExoSeal closure without major VCD-related complications; procedural success as hemostasis within 5 minutes. Statistical analysis was performed using a logistic regression model and correlation analyses., Results: 145/148 (98.0%) ExoSeal closures were technically successful (5F: n = 76; 6F: n = 65; 7F: n = 7). Angiographic control showed closure after 2 minutes in 130/145 cases. In a further 14 cases hemostasis was achieved after an additional 3 minutes MC, so that closure was successful within 5 minutes in 144/148 cases (97.3%). No major complication occurred. One minor complication was recorded in a 6F access case. Pre-interventional activated partial thromboplastin time (aPTT) was the only statistically significant predictor of necessary manual compression (MC) > 2 minutes (p = .01), but with an odds-ratio of only 1.038. The INR showed an odds-ratio of 2.455 for need for 5 minutes MC (NS). Significant correlations were found between the need for 5 minutes MC and medication with acetylsalicylic acid (p = .01), clopidogrel (p < .01), and abciximab (p < .001)., Conclusion: ExoSeal vascular closure of antegrade femoral punctures is safe and effective with a low complication rate. Two minutes of MC are sufficient to achieve hemostasis in the majority of cases. However, in patients on antiplatelet therapy, especially after abciximab, the authors advocate prolonging MC to 5 minutes., (Copyright © 2014 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.)

Heavy calcified arterial lesions are challenging to endovascular treatment. Even if a guide wire passes the lesion, calcified plaque can inhibit passage or dilation of the balloon catheter. We developed a novel technique of percutaneous direct needle puncture of calcified plaque (PIERCE) to allow subsequent passage and dilation of the balloon. PIERCE was performed in three patients with superficial femoral artery (SFA) lesions and one patient with a tibial artery lesion. In all four cases, balloon passage and lesion dilatation were achieved. Minor hemorrhage from the punctured site occurred in two patients with SFA lesions, which resolved with stent placement., (Copyright © 2014 SIR. Published by Elsevier Inc. All rights reserved.)

Objectives: The Micropuncture® 21-gauge needle may reduce complications related to vessel trauma from inadvertent venous or posterior arterial wall puncture., Methods: This was a single-center, multiple-user trial. Four hundred and two patients undergoing possible or definite percutaneous coronary intervention (PCI) were randomized 1:1 to an 18-gauge versus a 21-gauge needle. Patients and personnel pulling the sheaths and performing the follow-up were blinded. The primary end point was a composite of access bleeding. Events were tabulated following sheath removal, ≤ 24 h after the procedure and at the follow-up (at 1-2 weeks). End points were blindly adjudicated., Results: The event rate overall was 12.4% and did not differ significantly between groups, although the 21-gauge needle was found to reduce events by more than one third. An exploratory subgroup analysis of prespecified variables indicated that: patients who did not undergo PCI or elective procedures, female patients and those with a final sheath size of ≤ 6 Fr all had a significant or near-significant reduction of complications with Micropuncture., Conclusions: Although no significant differences between the use of the 18- and 21-gauge needles were observed, there was a 50-75% reduction with Micropuncture in several subgroups. The study was terminated prematurely. Access site complications may be reduced by the use of the 21-gauge needle, particularly when the risk of bleeding is not high. Further multicenter data will be required to confirm these hypothesis-generating observations., (© 2014 S. Karger AG, Basel.)

Purpose: To retrospectively evaluate the safety and effectiveness of the EXOSEAL vascular closure device (VCD) for first or repeated closure after retrograde percutaneous femoral arterial access., Materials and Methods: A retrospective analysis of 417 patients (271 men; mean age, 64.1 y±12.8; age range, 22-94 y) who had undergone arterial closure with the EXOSEAL VCD was performed. Procedures with retrograde femoral access and closure with the 5-F, 6-F, or 7-F EXOSEAL VCD according to the manufacturer's instructions were included. The clinical indications included the full procedural portfolio of a radiologic department with a focus on transarterial hepatic procedures. After EXOSEAL VCD closure, patients were restricted to bed rest for 4 hours., Results: From August 2010 to March 2012, a total of 682 EXOSEAL VCDs (5-F, n = 276; 6-F, n = 394; 7-F, n = 12) were used in 659 procedures with a total of 404 repeated closures. The EXOSEAL VCD was used successfully in 676 of 682 procedures (99.1%). Hemostasis was achieved in 651 of 682 procedures (95.5%). No major complications were encountered. There were eight cases (1.17%) of minor complications despite a successful vascular closure procedure, none requiring further therapy. There were no complications in any of the 404 cases of repeated vascular closure., Conclusions: The results of this study suggest that the EXOSEAL VCD is safe and effective in single and repeated closure of retrograde percutaneous femoral arterial access in interventional radiology cases., (Copyright © 2013 SIR. Published by Elsevier Inc. All rights reserved.)

Objective: To present results of a registry of a novel vascular access device., Background: Arterial access has been largely unchanged for 60 years. The Arstasis device creates a novel shallow-angle arterial access designed to facilitate hemostasis without use of a vascular closure device (VCD) or implantation of a foreign body for closure. This is the first publication to report the outcomes of Arstasis access., Methods: Patients (n = 346) underwent routine diagnostic cardiac catheterization (Dx) at 8 sites in the United States. Patients were assessed for device success, time to hemostasis (TTH), early sit up, time to ambulation (TTA), time-to-discharge-eligibility (TTDe) as well as safety; 249 patients had Dx only, 97 crossed over to PCI., Results: Device deployment was successful in 97%; the other 3% converted to routine access. Mean TTH and TTA for Dx were 4.0 ± 2.5 minutes and 1.5 ± 1.2 hours, respectively; for PCI it was 6.9 ± 5.1 minutes and 3.2 ± 3.3 hours. A subset of 245 patients (72.9%) sat up within 30 minutes after hemostasis; early sit-up was successful in all but 1 (99.6%). TTDe for Dx was 2.7 ± 1.6 hours. There were no major access-site related complications; minor complications were primarily subclinical hematomas in 1.2%., Conclusions: Arstasis access is associated with short TTH and TTA, early sit up after sheath pull, and accelerated TTDe, achieved without use of VCDs or implantation of a foreign body, with high success and minimal complication rates.

Background: Collagen-based vascular closure devices (VCD) are commonly used after catheterization with femoral access. However, data about complication rates due to the utilization of VCDs in patients with known peripheral artery disease (PAD) of the lower limbs are inconsistent and patients with significant PAD are excluded in most VCD trials. In this study, we aimed to assess complication rates of collagen-based VCDs in patients with significant PAD., Methods: Patients with significant PAD treated with a VCD (Angio-Seal; St Jude Medical, Inc) after percutaneous therapeutic interventions of lower extremities were included in this study. Significant PAD was defined as Fontaine ≥2b. In-hospital complications (bleeding, spurious aneurysm, vessel occlusion, dissection, surgical repair, vasovagal reaction) were recorded., Results: A total of 121 patients (64.6 ± 11.3 years, 77% male) were included. PAD stage IIb was present in 99 patients (stage III in 8 patients, stage IV in 14 patients). A total of 112 treatments (93.3%) processed without complications (major complication rate, 1.7%; minor complication rate, 5.0%). There was a trend toward higher prevalence of complications with increasing size of closure device and with the stage of PAD; however, this trend was not statistically significant (P>.05 for all)., Conclusion: We report moderate complication rates of collagen-based VCDs in patients with significant PAD. Our data suggest that Angio-Seal may be safe in patients with PAD after catheter intervention. Further randomized trials with larger sample size comparing VCD with standard manual compression in patients with significant PAD are required.

Background: We describe a vascular closure technique, convenient in practice, that permits effective femoral artery closure after CoreValve (Medtronic) implantation during transcatheter aortic valve implantation (TAVI). Vascular complications of transfemoral access implantation have been associated with significantly increased patient morbidity and mortality, as well as with increased hospitalization, among patients undergoing TAVI., Technique: The crossover technique is performed while using the sheath dilatator in order to tightly grasp the crossover wire; a peripheral artery balloon is inserted in the iliac artery and inflated above the puncture site. The 18 Fr sheath is removed while hemostasis is achieved in that way. Minor vascular complications were observed in 10% (3 out of 30) of the patients treated with this vascular closure technique. No major vascular complications were observed., Conclusions: The described vascular closure maneuver is operator friendly, without demanding special skills and can be added to the therapeutic quiver for minimizing vascular complications after TAVI.

Objective: To investigate the early effectiveness of total percutaneous endovascular aneurysm repair (TPEVAR) in treating asymptomatic abdominal aortic aneurysm (AAAA) by comparing with surgical femoral cutdown endovascular aneurysm repair (SFCEVAR)., Methods: Between January 2010 and May 2011, 41 cases of AAAA were treated with TPEVAR in 26 cases (TPEVAR group) and with SFCEVAR in 15 cases (SFCEVAR group). The maximum tumor diameter ranged from 3.5 to 9.2 cm (mean, 5.7 cm) in TPEVAR group, and ranged from 3.5 to 10.0 cm (mean, 6.9 cm) in SFCEVAR group. There was no significant difference in gender or age between 2 groups (P > 0.05)., Results: All patients underwent EVAR successfully. The patients were followed up 6-23 months (mean, 13.5 months). No significant difference was found in the outer diameters of the delivery system for main body and iliac leg, operation time, contrast media dosage, hospitalization days, or postoperative hospitalization days between 2 groups (P > 0.05). The patients of SFCEVAR group had more bleeding volume and longer ICU stay than patients of TPEVAR group (P < 0.05). The incidence of minor complication was 7.7% (2/26) in TPEVAR group and 33.3% (5/15) in SFCEVAR group, showing no significant difference between 2 group (chi2=4.42, P=0.08); the incidence of major complication in SFCEVAR group (20.0%, 3/15) was significantly higher than that in TPEVAR group (0) (chi2=5.61, P=0.02)., Conclusion: TPEVAR shows safer and more effective than SFCEVAR in treating AAAA.

Purpose: The safety and effectiveness of a percutaneous suture-mediated closure system for achieving hemostasis using a transarterial femoral approach were investigated., Materials and Methods: A percutaneous suture closure system (Perclose/Proglide, Abbott Vascular, Redwood City, California) was used in 2200 patients (average age 67.5 ± 12.5 years) who had undergone an angiographic intervention. Vascular access sites (1331 retrograde, 869 antegrade) with a sheath size of between 6F and 8F were closed. Platelet aggregation was inhibited with 100 mg/d ASA and all patients additionally received 5000 IU heparin peri-interventionally. After application of the suture-mediated closure system and achievement of sufficient hemostasis, a light compression bandage was applied in all patients and 6 hours of bed rest were recommended. The puncture site of all patients was checked using color-coded duplex sonography post-interventionally (following day and after 6 weeks)., Results: Immediate hemostasis was achieved in 2103/2200 patients (95.6 %). In the remaining 97/2200 cases, correct development of the suture was not possible, because of calcifications. In such cases, hemostasis was achieved by manual compression. Major complications (0.4 %) involved 3 infections that required vascular surgical debridement with the use of an interposition graft. In addition, there were 5 cases of secondary bleeding requiring transfusion. Minor complications (15.6 %) involved 3 (0.14 %) pseudoaneurysms, 256 (11.6 %) groin hematomas (up to max. 3 cm) and 85 (3.9 %) palpable suture granulomas., Conclusion: At a puncture size of 6 - 8F, safe and effective hemostasis is possible with the percutaneous suture-mediated closure system., (© Georg Thieme Verlag KG Stuttgart · New York.)

Aims: The composition of CTO lesions changes significantly as they age. These changes may adversely affect PCI outcome. We present a robust ex vivo technique to measure the force required to puncture the proximal cap of CTOs, and to determine whether the puncture force differs according occlusion age to examine the effects of compositional changes over time on lesion stiffness., Methods and Results: Occlusions were created in 44 rabbit femoral arteries by thrombin injection. Between two and 15 weeks following induction, vessels were harvested and tested in a custom setup to determine the force required to puncture the proximal cap. The puncture force mean values at 2, 6, 12, and 15 weeks were 0.61N, 0.78N, 1.21N and 1.52N, respectively. The puncture force required in occlusions of ≤6 weeks was significantly lower those≥12 weeks (0.72±0.10N versus 1.45±0.13N, p<0.01). Using a cutoff point of 1N, 86% of lesions≤6 weeks of age required<1N compared to 30% of those≥12 weeks., Conclusions: We have shown an objective and reproducible testing system for measuring CTO puncture force. Puncture force is correlated with occlusion age. This technique would be useful to evaluate therapies that alter CTO composition/compliance, as well as guidewire testing.

Purpose: To determine the safety and efficacy of total percutaneous access closure for endovascular aortic aneurysm repair with a suture-mediated preclosing technique., Materials and Methods: One hundred thirty-two femoral access sites in 70 patients who underwent endovascular aortic aneurysm repair were closed percutaneously with off-label use of two F-6 Perclose AT devices preapplied at a 90 degrees angle. Femoral access sizes ranged from 12 to 24 F. Technical success, complications, and procedure and access closure times were evaluated. Follow-up with computed tomography and/or magnetic resonance imaging was scheduled at 1-4 days and 3, 6, and 12 months and used to obtain groin hematoma and scar severity scores (grades 1-3). Data were compared with those from a cohort of 67 patients who underwent endovascular aortic aneurysm repair with surgical femoral cutdown., Results: Technical success was achieved with the preclosing technique in 127 of the 132 arteries (96.2%). Two to four closure devices were used per groin. Five technical failures were managed intraoperatively with surgical suture. There was no access-related mortality and no late groin complications. The mean procedure duration was 91 minutes +/- 32, and the mean access closure time was 12 minutes +/- 9. For surgical management, the mean procedure time was 153 minutes +/- 112 (P < .05), and the mean closure time was 12 minutes +/- 13 (not statistically significant). Hematoma severity score at 1-4 days was 1.8 for total percutaneous endovascular aneurysm repair and 2.1 for surgical closure. Scar severity scores at 3, 6, and 12 months were 1.1, 1.0, and 1.0 for total percutaneous endovascular aneurysm repair and 2.4, 2.4, and 2.3 for surgical management, respectively., Conclusions: Total percutaneous endovascular aneurysm repair with a dual 6-F-Perclose preclosing technique is safe and effective. Compared with femoral cutdown, there are fewer late groin complications and scar tissue formation is less severe.

We compared the use of manual compression and Angio-Seal and Starclose arterial closure devices to achieve hemostasis following common femoral artery (CFA) punctures in order to evaluate safety and efficacy. A prospective nonrandomized, single-center study was carried out on all patients undergoing CFA punctures over 1 year. Hemostasis was achieved using manual compression in 108 cases, Angio-Seal in 167 cases, and Starclose in 151 cases. Device-failure rates were low and not significantly different in the two groups (manual compression and closure devices; p = 0.8). There were significantly more Starclose (11.9%) patients compared to Angio-Seal (2.4%), with successful initial deployment subsequently requiring additional manual compression to achieve hemostasis (p < 0.0001). A significant number of very thin patients failed to achieve hemostasis (p = 0.014). Major complications were seen in 2.9% of Angio-Seal, 1.9% of Starclose, and 3.7% of manual compression patients, with no significant difference demonstrated; 4.7% of the major complications were seen in female patients compared to 1.3% in males (p = 0.0415). All three methods showed comparable safety and efficacy. Very thin patients are more likely to have failed hemostasis with the Starclose device, although this did not translate into an increased complication rate. There is a significant increased risk of major puncture-site complications in women with peripheral vascular disease.

Objectives: The authors studied the safety and efficacy of the Cardiva Boomerang vascular closure device in patients undergoing diagnostic cardiac catheterization., Background: Conventional vascular closure devices (sutures, collagen plugs, or metal clips) have been associated with catastrophic complications including arterial occlusion and foreign body infections; furthermore, they cannot be utilized in patients with peripheral vascular disease or vascular access site in a vessel other than the common femoral artery. The Cardiva Boomerang device facilitates vascular hemostasis without leaving any foreign body behind at the access site, can be used in peripheral vascular disease, and can be used in vessels other than the common femoral artery, Methods: A total of 96 patients undergoing transfemoral diagnostic cardiac catheterization were included in this study, including 25 (26%) patients with contraindications to conventional closure devices. Femoral angiography was performed prior to deployment of the Cardiva Boomerang closure device. Patients were ambulated at 1 hr after hemostasis was achieved., Results: The device was successfully deployed and hemostasis achieved with the device alone in 95 (99%) patients. The device failed to deploy in 1 (1%) patient and required conversion to standard manual compression. Minor complications were observed in 5 (5%) patients. No patients experienced major complications including femoral hematoma > 4 cm, red blood cell transfusion, retroperitoneal bleed, arteriovenous fistula, pseudoaneurysm, infection, arterial occlusion, or vascular surgery., Conclusions: The Cardiva Boomerang device is safe and effective in patients undergoing diagnostic cardiac catheterization using the transfemoral approach, facilitating early ambulation with low rates of vascular complications., ((c) 2006 Wiley-Liss, Inc.)

Purpose: To compare complications and outcomes between the use of the Duett collagen closure device after one or multiple deployments and manual compression in patients treated with transcatheter arterial chemoembolization (TACE) for primary or metastatic liver cancer., Materials and Methods: A database of 214 patients who underwent a total of 426 TACE procedures between July 2001 and July 2003 was retrospectively analyzed with regard to the use of the Duett closure device to obtain hemostasis. The Duett device was used in 211 cases (121 patients), whereas manual compression was performed in 215 cases (93 patients). Primary endpoints included complications related to hemostasis, time to hemostasis (TTH), time to ambulation (TTA), and time to discharge (TTD). Risk factors were tested for correlation with complications (P < .05). Other endpoints included descriptive data regarding the Duett treatment group., Results: Only minor complications were observed in both groups, without a statistically significant difference (P = .16). The mean TTH and TTA were significantly shorter (P < .0001) in the Duett group, whereas there was no difference in TTD between groups (P = .59). Reaccessing the same arterial site for separate procedures was not a significant risk factor for complications in the Duett group (P < .0001)., Conclusion: The Duett closure device achieves similar safety and efficacy as manual compression in this distinct group of patients. In addition, this device can be safely and repetitively deployed at the arteriotomy site after each TACE procedure.

Purpose: A method to create an extraluminal femoropopliteal bypass graft using endovascular techniques was evaluated in situ on cadaver extremities in an attempt to develop a minimally invasive alternative technique for the management of infrainguinal occlusive arterial disease., Methods: The endovascular placement of an extraluminal femoropopliteal bypass graft was undertaken in 5 cadaver legs. Following percutaneous access to the popliteal artery (PA) or common femoral artery (CFA), a Rosch-Uchida needle was used to perforate the vascular wall, followed by the creation of an extraluminal tract using a looped wire and catheter. Once the desired level was reached the needle was again used to perforate the vascular wall of the proximal superficial femoral artery (SFA) or PA depending on the access used. Self-expanding expanded polytetrafluoroethylene (ePTFE) stent-grafts were then deployed to establish the extraluminal femoropopliteal bypass connecting the two arterial puncture sites. Following dilatation of the stent-graft, angiography was performed to assess the endoprostheses and to look for contrast leaks., Results: Technical success was achieved in all 5 legs. Procedure time varied from 15 to 30 min. The angiographic studies performed immediately after completion of the bypass procedure showed patency of the grafts with no evidence of kinking or leakage in any of the cases., Conclusion: This study has proved that the endovascular placement of an extraluminal femoropopliteal bypass graft in human cadaver legs using endovascular techniques under fluoroscopic control is technically feasible.

Background: Vascular complications at the femoral access site continue to be a significant problem after cardiac catheterization procedures. It was the aim of the present study to assess the impact of gender on the incidence of severe femoral access complications following the application of a collagen-based vascular closure device after transfemoral catheterization procedures., Methods: A total of 1,294 consecutive patients (977 male, 317 female) underwent closure of femoral access sites with 8F collagen-based vascular closure devices (Angioseal) immediately after diagnostic or interventional coronary catheterization procedures, independently of the coagulation status. All patients were closely monitored for the occurrence of complications during the following 24 hours., Results: Between male and female patients, there was no difference in the technical performance of the device with successful deployment being achieved in 96.7% and 95.9%, respectively (p=0.60). Severe access complications were found to be significantly higher in female versus male patients (1.6% vs. 0.2%; Odds ratio 7.7, 95% confidence interval 1.5-40.1; p=0.015), although similar accomplishment of an immediate hemostasis was seen in 92.8% and 92.4% of male and female patients (p=0.98)., Conclusion: Women show a significantly increased risk of developing severe femoral access complications secondary to the application of a collagen-based vascular closure device, although the overall incidence of these complications is relatively low. We speculate that the increased risk in women may be related to smaller arterial dimensions, which could be evaluated by femoral angiography prior to deployment of a closure device.

Background: While each of the available femoral arterial sealing devices claims equivalent safety to manual compression following invasive cardiac procedures, these claims are based on small, underpowered studies. Our aim was to increase the ability to detect a clinically meaningful difference by performing a meta-analysis., Methods: We identified studies via Medline and manual searches and selected studies that were prospective, randomized clinical trials for inclusion. Pooling of data was performed by calculation of the Mantel-Haenszel odds ratio (OR) and the variance of the OR was estimated using the method of Robins, Greenland and Breslow., Results: Sixteen studies enrolling 5,048 patients were included in the analysis. The pooled OR was 0.89 (95% confidence interval, 0.86-0.91), indicating a significant decrease in risk by devices. Excluding hematomas from the endpoint resulted in a concordant result. Angio-Seal was associated with a significant reduction in risk (OR, 0.51) and Perclose had a neutral result (OR, 1.0), whereas Vasoseal had an increased risk of complications (OR, 1.18)., Conclusion: Overall, sealing devices may be associated with a reduction in risk of complications following invasive coronary procedures, but significant differences may exist among individual devices. These potential differences need to be explored in randomized, controlled clinical trials.

Different protocols exist concerning the method and timing of post-coronary angioplasty arterial puncture site closure. Easy handling and good effectiveness are well-documented for the Femostop femoral artery compression system; however, no hard data exist concerning the relationship between heparin anticoagulation level and femoral artery compression time (FSCT). Thus, we prospectively randomized 267 patients after elective percutaneous transluminal coronary angioplasty (PTCA) into two groups [group A (n=137) had early sheath removal 6 to 8 hours after PTCA; group B (n=130) had late sheath removal 14 to 16 hours after PTCA] and analyzed the dependence of the FSCT on the heparin anticoagulation level (aPTT) and the incidence of vagal reactions and puncture site complications. FSCT was significantly longer in group A (69+/-27 minutes versus 45+/-15 minutes; p<0.001) with high heparin anticoagulation level (aPTT, 88+/-46 seconds) in comparison to group B with low heparinization (aPTT, 59+/-34 seconds). Vagal reactions occurred more frequently in group A (15.3% versus 10.0%; p<0.01) and the incidence of minor hemorrhage at the arterial puncture site was also increased (9.5% versus 3.1%; p<0.05). In the clinical setting of intensive heparin anticoagulation and early sheath removal after PTCA (<8 hours), the FemoStop system cannot be recommended due to prolonged femoral artery compression times.

Introduction: The growing use of abciximab during coronary angioplasty, with 12 hours of intravenous perfusion, prolongs hospital stay and increases the risk of hemorrhage after sheath removal at the puncture site. Femoral percutaneous closure devices can reduce immobilization time, but their safety in the presence of abciximab in respect to hemorrhage has not been clearly determined., Objectives: To evaluate the safety and efficacy of the Perclose system in patients undergoing angioplasty with abciximab., Population and Methods: The Perclose system was used in 79 patients undergoing angioplasty, with abciximab in 31 patients (58.6 +/- 12.2 years, 90% male, p = NS)--Group 1, and 48 pts without abciximab (61.8 +/- 10.9 years, 79% male, p = NS)--Group 2. We compared heparin dose, sheath diameters, primary success rate, coronary care unit admissions and minor and major complications. One patient was previously anticoagulated with warfarin and all the others were on oral antiplatelet therapy before and after angioplasty., Results: Primary success with the use of the Perclose system was 78%. We found no significant statistical differences between groups in respect to the presence of diabetes, sheath diameter or referral for intervention. Heparin dosage was slightly higher in group 2 (p = 0.09) and ACT was also higher in group 2 (p = 0.01). More patients in group 1 had delayed ambulation (p = 0.04) due to abciximab perfusion. In 7 patients in group 1 and 9 in group 2, additional manual/mechanical compression was needed for moderate bleeding in the first hours (p = NS). One rupture of the femoral artery with need for surgical repair (primary failure) and another delayed rupture (48 hours) occurred in group 1 (both with an associated infection), and 1 pseudoaneurysm in a patient from group 2, without abciximab but taking warfarin (p = NS). None of the variables analyzed determined the occurrence of complications. Only oral anticoagulation determined the occurrence of major complications., Conclusions: User of the Perclose system for percutaneous closure of the femoral artery in patients undergoing coronary angioplasty with simultaneous use of abciximab was not associated with greater morbidity than in patients without glycoprotein IIb/IIIa receptor antagonists.

Background: The wide range of closure devices for arterial access sites still leaves room for improvement., Methods and Results: We report our initial experience with a novel, cost-effective, suture-mediated device (6 French X-PRESS device, X-SITE Medical, Blue Bell, Pennsylvania) for closure of the arterial access site after both diagnostic and therapeutic interventions. A total of 51 consecutive patients are reported. The closure was performed immediately after the procedure. No patient had more than 5,000 U heparin administered during the procedure. The closure device was used in 36 patients (73%) after diagnostic angiography and in 15 patients (27%) after therapeutic intervention. The device could be successfully deployed in 48 patients (94%). In the remaining 3 cases (6%), hemostasis was achieved with standard manual compression without any further event. Immediate total hemostasis was achieved with the device in 44 of 48 patients (92%). Four devices (8%) could not be deployed correctly due to technical problems and the patients needed additional manual compression. The average time to achieve complete hemostasis was 5.5 +/- 3.5 minutes (range, 3-26 minutes). The patients were ambulated after a period of 1.3 +/- 0.4 hours of bedrest (range, 0.8-3.5 hours). Time to possible discharge was 4.2 +/- 3.4 hours (range, 0.9-12.5 hours). One patient experienced a minor complication (hematoma < 6 cm) and was treated with manual compression without clinical sequelae. Telephone follow-up was carried out 2 weeks after deployment and revealed no sequelae., Conclusion: The 6 French X-PRESS device is safe and effective in providing rapid hemostasis following interventional or diagnostic catheterization procedures. Use of the device is associated with a low rate of complications and facilitates quick hemostasis, mobilization and discharge.

Background: Vascular access site management is crucial to safe, efficient and comfortable diagnostic or interventional transfemoral percutaneous coronary procedures. Two new femoral access site closure devices, Perclose and Angio-Seal , have been proposed as alternative methods to manual compression (MC). We compared these two devices and tested them in reference to standard MC for safety, effectiveness and patient preference., Methods: Prospective demographic, peri-procedural, and late follow-up data for 1,500 patients undergoing percutaneous coronary procedures were collected from patients receiving femoral artery closure by MC (n = 469), Perclose (n = 492), or Angio-Seal (n = 539). Peri-procedural, post-procedural, and post-hospitalization endpoints were: 1) safety of closure method; 2) efficacy of closure method; and 3) patient satisfaction., Results: Patients treated with Angio-Seal experienced shorter times to hemostasis (p < 0.0001, diagnostic and interventional) and ambulation (diagnostic, p = 0.05; interventional, p < 0.0001) than those treated with Perclose. Those treated with Perclose experienced greater access site complications (Perclose vs. Angio-Seal, p = 0.008; Perclose vs. MC, p = 0.06). Patients treated with Angio-Seal reported greater overall satisfaction, better wound healing and lower discomfort (each vs. Perclose or vs. MC, all p < or = 0.0001). For diagnostic cath only, median post-procedural length of stay was reduced by Angio-Seal (Angio-Seal vs. MC, p < 0.0001; Angio-Seal vs. Perclose, p = 0.009). No difference was seen in length of stay for interventional cases., Conclusions: Overall, Angio-Seal performed better than Perclose or MC in reducing time to ambulation and length of stay among patients undergoing diagnostic procedures. There was a higher rate of successful deployment and shorter time to hemostasis for Angio-Seal, and this was accomplished with no increase in bleeding complications throughout the follow-up. Additionally, Angio-Seal performed better than Perclose in exhibiting a superior 30-day patient satisfaction and patient assessment of wound healing with less discomfort.

Purpose: A new hemostatic puncture closure device (HPCD) was evaluated following femoropopliteal angioplasty. Efficacy in hemostasis and complications were compared between manual compression and the new system., Methods: One hundred patients undergoing percutaneous interventional procedures were randomly assigned to receive either manual compression or HPCD. The time to complete hemostasis (when a compression bandage was applied) was noted as well as complications such as hematoma or arterial stenosis at the puncture site. Follow-up was by clinical examination and color-coded duplex sonography (CCDS)., Results: With the HPCD, immediate hemostasis was achieved in 22 patients (44%). Discrete oozing without the necessity of external compression or further consequences was observed in 11 patients. Mean manual compression time was 25 (+/- 20) min including application of the pressure bandage. Eleven patients needed additional manual compression and technical failures were observed in 6 patients (12%). The compression time in these 17 cases was 27 (+/- 12) min. Subcutaneous hematomata with a diameter of more than 5 cm developed in 15 of 48 patients in the HPCD group and in 14 of 48 patients in the manual compression group. No surgical or percutaneous intervention was necessary. The complication rate was comparably low in the experimental and control groups., Conclusion: Compared with manual compression HPCD is faster and more accurate for sealing the arterial puncture defect following angioplasty. After an initial learning curve, it is easy to handle and time-saving as well as convenient for the patient. Furthermore, immediate and full anticoagulation is possible and arterial inflow is not compromised. A drawback is the necessity of an 8 Fr sheath. Nevertheless, the complication rate is comparably low for both methods.

The number of local complications after heart catheterization by transfemoral approach can be lowered by optimized compression technique in spite of shortened compression time. It requires a long-term (> 30 minutes) acute compression after removing the sheaths and stable pressure during the following compression period. To achieve this issue the deployment of a novel compression device is superior to the combination of manual compression and conventional pressure dressing. A pressure of 40 to 45 mmHg is sufficient and well tolerated. Local complications as pseudoaneurysms and arteriovenous fistulas are detected by duplexsonography with high sensitivity. Only about 50 percent of pseudoaneurysms are identified by physical examination in contrast to arteriovenous fistulas which are rarely missed because of their characteristic murmur. The early ultrasound-guided compression therapy is considered to be a safe treatment of pseudoaneurysms but is not effective in arteriovenous fistulas. Risk factors of local complications are high blood pressure, multiple arterial puncture and local-anatomical conditions. Compression-related factors are short acute compression (phi 14.3 minutes) and loss of pressure during the following compression period.

A new device that enables closure of the femoral artery puncture site by percutaneous placement of two nonabsorbable sutures (Prostar) was evaluated. Our initial experience included 32 insertion attempts at 29 femoral arterial puncture sites and one femoral venous puncture site. The device was applied at arterial puncture sites that had been used to carry out 12 balloon angioplasties (41%), seven intracoronary stent placements (24%), five intraaortic balloon pump insertions (17%), four diagnostic angiographies (14%), and one rotational ablation (3%). The venous access site closed was in a patient who had undergone balloon angioplasty and intracoronary thrombolysis. Most patients were anticoagulated with an average activated clotting time (ACT) of 306 +/- 123 sec (12 patients) or an average PTT of 68 +/- 29 sec (14 patients). There were four failures to achieve hemostasis using the device due to: inability to place the device because of peripheral vascular disease, entrapment of cutaneous tissue in the suture, a suture break that prevented hemostasis from being achieved, and avulsion of the sutures from the needles. Although three other suture breaks occurred, these did not prevent hemostasis from being achieved. Thus, 88% (28/32) of attempted uses were successful, and by using a second device in two of the failed attempts, 94% (30/32) of the puncture sites were successfully closed using the device. There was one late rebleed that required 1 hr of groin clamp pressure in an angioplasty patient who had received intracoronary urokinase. An ooze of blood occurred in 4 patients, but in only 2 was this more than trivial, resulting in discontinuation of heparin in one patient and a small hematoma in the other. We conclude that this device can be used safely and effectively, even in fully anticoagulated patients who have undergone complex procedures. The ultimate role of the device will require further experience and appropriate randomized studies.

Over a period of 5 years 81 vascular complications after 15,460 catheterizations of the femoral artery for diagnostic (n = 11,883) or therapeutic (n = 3577) procedures were registered. The following complications were observed in declining frequency: 1. False aneurysm (n = 65), 2. arterial occlusion (dissection, embolia, thrombosis) (n = 8), 3. vascular lesion causing profuse bleeding (n = 7), 4. AV-fistula (n = 1). The total complication rate was 0.52%. The complication rate was significantly higher in therapeutical procedures (1,03%) than in diagnostic investigations (0.37%). Pseudoaneurysms were complicated by thrombosis of the femoral vein (n = 3), lymphatic fistula (n = 3) and deep wound infection (n = 9); secondary complication rate 18.5%. Risk factors for local vascular complications are old age, female gender, high grade arteriosclerosis at the puncture site, overweight, manifest arterial hypertension and medication with cumarin, acetylsalicylic acid or heparin. Further complicating factors are connected with technical risks such as duration of the procedure. French size of the catheter, the catheter sheath and multiple punctures. Vascular repair was performed by simple angiography in most cases, but in 14.8% more extensive surgical procedures were required. In patients with signs of occlusive vascular disease the external iliac artery was replaced by a PTFE-vascular access graft in 4 cases and an arterioplasty of the deep femoral artery was performed in 2 patients. 36% of the operations were undertaken as emergencies. Reintervention was necessary for a postoperative bleeding complication in 1 case (surgical complication rate 1.2%). A female patient suffering from aortic valve stenosis died during emergency operation due to massive retroperitoneal hemorrhage after cardiac catheterization (mortality rate 1.2%). Over a median follow-up period of 37 months no late complications of the intervention were recorded, nor recurrences of peripheral arterial occlusive disease.

Purpose: To determine the prevalence of transient femoral nerve anesthesia following transfemoral angiographic procedures., Patients and Methods: Fifty-eight patients undergoing a variety of routine transfemoral procedures underwent a neurologic assessment within an hour of the procedure., Results: Nine patients (16%) were found to have complete or partial deficits in the ipsilateral femoral nerve territory. All deficits were transient., Conclusions: Transient femoral nerve deficits are not uncommon following transfemoral procedures. With the advent of true outpatient vascular procedures (where the patient may walk away after only a 30-minutes recovery period following a transvenous intervention or after 60 minutes following arteriography), transient neurologic problems related to the infiltration of local anesthetic around the femoral artery assume real clinical importance.

After angiography, 6 to 24 hours of bedrest is indicated to assure that adequate hemostasis of the femoral artery has been achieved. Recently, a new hemostatic puncture closure device (HPCD) has been developed, which consists of a resorbable polymer anchor, a resorbable suture, a small collagen plug and an 8Fr delivery device. The device is delivered into the femoral artery through the introducer sheath, the anchor is secured against the intraluminal artery wall, and the collagen plug is deployed on the arterial wall. The prototype of the HPCD was used in 20 patients administered heparin. After insertion of the HPCD, hemostasis was achieved in 1.2 +/- 2.1 minutes; in 2 patients a light pressure dressing was applied for 4 hours to stop oozing. No late bleeding occurred. In 1 patient the positioning suture broke, requiring the application of a pressure bandage. Patients were uneventfully mobilized after 6.7 +/- 3.5 hours. In all patients serial duplex scanning of the femoral artery was performed before and after 1, 7, 30 and 90 days after HPCD placement. In 5 patients a small subcutaneous hematoma close to the site of introduction could be detected by ultrasound 1 day after catheterization. All but 1 patient had normalization of the flow patterns in the femoral artery. It is concluded that: (1) the HPCD is an effective device to achieve immediate hemostasis after arterial catheterization despite antithrombotic therapy, (2) early mobilization was uneventful, (3) duplex ultrasound studies demonstrated only transient changes in the punctured femoral artery, and (4) further investigations are needed to establish the efficacy and safety of the device.

Antegrade puncture of the femoral artery is often the first step in angioplasty or thrombolysis of the lower limb. Because of presumed complications, mostly from anecdotal literature, the common femoral artery is the preferred site of entry. From there, selective catheterization of the superficial femoral artery can be performed. This two-step procedure is sometimes long and difficult for both the patient and the radiologist. To improve the ease and the rapidity of this procedure, the author performed direct antegrade puncture of the superficial femoral artery during 25 consecutive antegrade approaches. The only local complication was hematoma, which developed in two patients but disappeared spontaneously. Aggravating factors were the size of the catheters used and fibrinolytic therapy in one of the affected patients. The results of this pilot study suggest strongly that direct antegrade puncture of the superficial femoral artery is safer than might be expected from the literature, which deals primarily with retrograde puncture. This approach must now be systematically compared with the "classic" common femoral artery approach.

One hundred patients undergoing routine diagnostic or interventional catheterization were randomly assigned to receive either percutaneously applied collagen (group A; n = 50) or conventional pressure dressing (group B; n = 50) for sealing of the femoral artery. Clinical variables were comparable in both groups. The heparin dose was 100 IU/kg in 30 patients and 200 IU/kg in 20 patients of both groups. The average compression time was 4.3 min in group A and 42.3 min in group B (p < 0.001). In group A, 1/50 patients required pressure dressing compared to 50/50 patients in group B. Bleeding was not observed in group A, but was observed in 6/50 patients in group B. The time to ambulation was 6.4 (range, 4-12) h in group A and 21.6 (range, 10-48) h in group B (p < 0.001). Hematomas with a diameter of > 6 cm developed in 4/50 patients in group A and in 11/50 patients in group B (p < 0.05). Blood-transfusions or surgical interventions were not required and there was no loss of ankle pulses in either group. In conclusion, percutaneously applied collagen reduced compression time and duration of bedrest after diagnostic catheterization and PTCA. Despite earlier ambulation, the incidence of bleeding was lower with collagen than with conventional pressure dressing.

Inability to access occluded grafts is a major limitation to successful thrombolysis and may even preclude it. This paper addresses the problem and offers a new technique of direct puncture of prosthetic grafts through which thrombolysis and angioplasty can be performed. These techniques resulted in accelerated thrombolysis in all 15 patients studied with no failures due to inability to attain graft access.

A modified technique of puncture and catheterization of the femoral vessels in children and a detailed description of the stages of the examination are presented. An analysis of 350 angiographies with the use of the modified puncture and catheterization technique in children aged from 1 month to 15 years was carried out. Technical errors were noted in 16 children (4.3%) and complications in 3 (0.85%). The presented observations prove that the given modification of the catheterization technique is not a very traumatic one and allows to avoid many undesirable complications which may arise especially at the stage of mastering the described method.