Current perspectives on British use of adjunctive therapies during coronary interventions.

BACKGROUND: Interventional techniques are commonly performed with adjunctive therapy including clopidogrel, ticlopidine, abciximab and heparin. We wished to assess the current British use of antiplatelet and anticoagulant agents as adjunctive therapies in interventional cardiology in the light of the available evidence base regarding their usage. METHODS: A simple structured questionnaire was sent between August and October 1999 to all interventional cardiology consultants working in the UK regarding their usage of abciximab (ReoPro), heparin, clopidogrel (Plavix) and ticlopidine (Ticlid) peri-procedurally. RESULTS: 68% of consultants responded over the next 4 months, with many replying jointly for a centre rather than individually. Average abciximab use was 8.3% of interventional cases. Eighty-two percent of clinicians used clopidogrel in stented patients. Exact dosages varied considerably. Fifty-three percent of clinicians gave 10000 IU or more of heparin routinely. CONCLUSIONS: These figures are not in line with the published evidence and British interventionists appear to have adopted various strategies to target the use of these agents. In particular, abciximab appears to be being administered reactively, as and when problems arise in the catheterisation lab.     

Early clinical experience with the 6 French Angio-Seal device: immediate closure of femoral puncture sites after diagnostic and interventional coronary procedures.

The objective of this study was to assess the early safety and efficacy of the novel 6 Fr Angio-Seal device for routine clinical use after diagnostic cardiac catheterization and coronary angioplasty. In a prospective study, we used the 6 Fr Angio-Seal device in 180 consecutive patients (131 male, 49 female, mean age 60.7 years) for closure of femoral arterial puncture sites immediately after diagnostic (n = 108) or interventional (n = 72) coronary procedures independent of the coagulation status. All patients were monitored for 24 hr after the procedure and followed for 30 days. The closure device was successfully deployed in 95.4% after diagnostic catheterization versus 98.6% after coronary angioplasty (P = 0.963). Immediate hemostasis was achieved in 91.5% versus 90.1% of the patients (P = 0.993). Major complications were observed 1.9% versus 2.8% of the patients (P = 0.885). During 30-day follow-up, no late events or complications were reported. The 6 Fr Angio-Seal device is a safe and effective device that allows for immediate closure of femoral puncture sites after both diagnostic and interventional procedures with a low rate of major complications.     

Femoral artery hemostasis using an implantable device (Angio-Seal™) after coronary angioplasty

Coronary catheter interventional procedures are associated with risk of access site complications. We report our experience with Angio-Seal™, an implantable hemostasis device, when used in the femoral artery after coronary angioplasty procedures. Sixty-eight patients were studied. Their average age was 63 years; 84% of the patients were male. All had 8 French access sheaths and received bolus heparin (mean dose 12,690 U). The arterial sheaths were removed an average of 455 min after the conclusion of the procedure, when the activated clotting time was 220 ± 94 sec (range 97–503 sec). The hemostasis device was successfully deployed in 63 patients (93%). The average time to achieve complete arterial hemostasis was 4.4 ± 8.9 min (range 0–45). Immediate, total hemostasis without requiring any form of external pressure was obtained in 37 of these patients (54%). The incidence of complications was as follows: significant bleeding occurred in 9 patients (13%); there were 2 hematomas (3%); there were no vascular or infectious complications. One device embolization occurred when the connecting suture broke and the intravascular anchor was lost; no clinical sequelae resulted, and manual hemostasis was successful. In four other patients, the device did not deploy and was removed entirely, followed by uneventful manual hemostasis. Follow-up for 2 months revealed no late sequelae in any patient, and complete absorption of the device was documented by ultrasound study in all cases. We conclude that this implantable device can achieve arterial hemostasis quickly and safely when used in anticoagulated patients after coronary interventional procedures. © 1996 Wiley-Liss, Inc.     

Closure of the femoral vein puncture site after transcatheter procedures using Angio-Seal.

The use of anchor-based, collagen-derived vascular sealing devices in femoral vein punctures during right and left heart catheterizations or coronary interventions necessitating venous access for temporary pacemaker or hemodynamic monitoring has not been studied. We hypothesized that using these devices in the femoral vein would be practical and reliable. One hundred and ten consecutive patients undergoing right and left heart catheterization (56 patients, 51%) or coronary intervention (54 patients, 49%) were included in this study. Forty-five of the interventions received IIb/IIIa inhibitors in combination with heparin, enoxaparin, aspirin, and clopidogrel. The Angio-Seal device was successfully deployed in the femoral vein in all patients, whereas 93 (85%) received arterial Angio-Seal, 8 received Perclose, and 9 (8%) had manual pressure or a Fem-Stop applied to control arterial bleeding after deployment. We conclude that in patients undergoing transcatheter procedures requiring venous access, the use of an 8 Fr Angio-Seal to seal the femoral vein is safe and feasible.     

Clinical evaluation of SyvekPatch in patients undergoing interventional,EPS and diagnostic cardiac catheterization procedures

BACKGROUND: The SyvekPatch (Marine Polymer Technologies, Danvers, Massachusetts) has received Food and Drug Association market clearance for the rapid control of bleeding from vascular access sites and percutaneous catheters. A clinical evaluation was designed to determine the efficacy and safety of this vascular closure device in 1,000 consecutive patients after routine diagnostic and interventional procedures. METHODS: During a 3-month period, a total of 364 interventional patients (stenting, 55%; PTCA, 30%; EPS, 15%) and 636 diagnostic patients (left heart catheterization, 77%; right/left heart catheterization, 23%) were treated. Catheter sheaths ranged in size from 4 12 French (Fr). Antiplatelet therapy was employed in 35% of the interventional procedures. In approximately 20% of the cases, same-side repuncture occurred within 2 3 days. RESULTS: The use of the SyvekPatch on a total of 1,000 consecutive patients resulted in the rapid control of bleeding with only 1 major complication (0.1%; pseudoaneurysm) and few minor complications (1.3%). The pseudoaneurysm was most likely caused by the aberrant location of the sheath. All minor complications were either small hematomas (< 2.5 cm; rate, 0.75%) or slight oozing from the puncture site (rate, 0.6%). Outcomes measured included clinical effectiveness, ability to maintain the femoral access site for future interventions, major complication rates (access-site related hematoma that required blood transfusion or an extended hospital stay, pseudoaneurysm, arteriovenous fistula, arterial or venous thrombosis, and infection), patient comfort and operational efficiency. CONCLUSION: The strong safety and efficacy profile of the SyvekPatch has made a significant impact in our cardiac catheterization lab. Unlike existing vascular closure devices, the SyvekPatch was used following a diagnostic procedure even when a future interventional procedure was scheduled. The effectiveness of the SyvekPatch was not altered by anticoagulation or antiplatelet therapy. The patients and clinical staff were extremely satisfied with the use of the SyvekPatch .     

Effectiveness and complications of vascular access closure devices after interventional procedures

BACKGROUND: Vascular closure devices are designed to obtain a fast hemostasis of the vascular access site after diagnostic and interventional procedures. This result should be obtained with a low incidence of complications. METHODS: A retrospective, non-randomized study was performed to evaluate the success rate and vascular complications associated with the use of two different vascular sealing devices [Angio-Seal (Daig Corporation, Minnetonka, Minnesota) and Prostar (Perclose, Inc., Redwood City, California)] after interventional procedures. RESULTS: Eight-hundred and twenty-seven devices were used (245 Angio-Seal and 582 Prostar). Angio-Seal success rate was 92% with a 2.5% rate of vascular complications; Prostar success rate was 89% with a 3.4% rate of vascular complications. Multivariate logistic regression analysis identified advanced age (p < 0.05) and lower weight (p < 0.05) as independent predictors of vascular complications associated with Angio-Seal use, while diabetes (p < 0.05) was found to be a predictor of vascular complications in the Prostar group. Abciximab use and larger sheath size were not associated with an increased probability of vascular complications. CONCLUSION: Angio-Seal and Prostar obtain a fast vascular access hemostasis after interventional procedures, with a low incidence of major vascular complications.     

Femoral arterial puncture management after percutaneous coronary procedures: a comparison of clinical outcomes and patient satisfaction between manual compression and two different vascular closure devices

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.     

Clopidogrel is associated with better in-hospital and 30-day outcomes than ticlopidine after coronary stenting

BACKGROUND: Recent reports of fatal ticlopidine-induced blood dyscrasias have led many interventional cardiologists to administer clopidogrel instead of ticlopidine for coronary stenting. Most studies have demonstrated similar outcomes and a more favourable safety profile supporting this change in practice patterns. OBJECTIVES: To assess the clinical outcomes in patients who received clopidogrel rather than ticlopidine after coronary stenting. METHODS: Between June 1996 and December 1998, 652 patients received a clopidogrel-based periprocedural regimen (300 mg loading dose followed by 75 mg daily in addition to acetylsalicylic acid 325 mg daily) and 1717 patients received a ticlopidine-based regimen (500 mg loading dose followed by 250 mg bid in addition to acetylsalicylic acid 325 mg daily). In-hospital and 30-day outcomes were assessed in the two groups. RESULTS: At 30 days, unadjusted mortality was 0.3% in the clopidogrel group versus 1.5% in the ticlopidine group, and myocardial infarction (MI) was also reduced in the clopidogrel group (4.0% versus 6.5%). No difference was found in the rate of repeat revascularization (1.4% versus 1.2%). The combination of death/MI/repeat revascularization at 30 days was reduced by 32%, an absolute difference of 2.9% (6.2% versus 9.1%). On multivariate analysis, clopidogrel was found to be an independent predictor of freedom from nonfatal MI (odds ratio [OR] 0.64, 95% CI 0.41 to 0.99, P=0.04), the composite of death or MI (OR 0.62, 95% CI 0.40 to 0.95, P=0.03) and the composite of death/MI/revascularization (OR 0.69, 95% CI 0.48 to 1.00, P=0.05). CONCLUSION: After coronary stenting, in a large, nonrandomized, consecutive patient experience, clopidogrel appears to be associated with more favourable clinical outcomes than ticlopidine, without increasing the risk of bleeding or peripheral vascular complications.     

Impact of Thienopyridine Administration Prior to Primary Stenting in Acute Myocardial Infarction

The impact of thienopyridine administration prior to primary stenting in acute myocardial infarction (AMI) has not been well studied. We therefore examined the database from the prospective, multicenter, controlled CADILLAC trial in which 1,036 patients were randomized to bare metal stenting with or without abciximab to determine whether patients who received a thienopyridine prior to bare metal stenting in AMI had superior clinical outcomes. Per operator discretion, 659 patients (63.6%; Th+) received either a 500 mg ticlopidine loading dose (n = 623) or a 300 mg clopidogrel loading dose (n = 40), while 377 patients (36.4%; Th-) received no thienopyridine prior to stent implantation. Baseline and procedural characteristics of the two groups, including abciximab use (52.5% vs 52.8%, P = 0.93) were well matched. Th+ compared to Th- patients had lower rates of core lab assessed TIMI 0/1 flow postprocedure (0.8% vs 2.7%, P = 0.01). Th+ compared to Th- patients also had significantly reduced in-hospital and 30-day rates of ischemic target vessel revascularization (TVR) (1.1% vs 3.2%, P = 0.01 and 1.5% vs 3.8%, P = 0.02, respectively) and major adverse cardiovascular events (MACE) (2.7% vs 5.8%, P = 0.01 and 4.0% vs 6.9%, P = 0.03, respectively), results that remained significant after covariate adjustment. In conclusion, in this large prospective, controlled trial, patients receiving a thienopyridine prior to primary stenting in AMI were less likely to have TIMI 0/1 flow postprocedure and experienced reduced in-hospital and 30-day rates of ischemic TVR and MACE compared to those not administered a thienopyridine prior to stent implantation.     

Femoral Arterial Hemostasis using the Angio-Sealª System after Coronary and Vascular Percutaneous Angioplasty and Stenting

The procedures of left cardiac catheterization and revascularization by angioplasty are associated with a substantial risk of hemorrhagic complications. This risk increases clearly in patients with an intravascular stent who require early high doses of anticoagulant therapy. The first purpose of our study was to evaluate the effectiveness of a mechanical system of femoral hemostasis (Angio-Seala, Sherwood Davis & Geck, St. Louis, Missouri) deployed in a group of 411 consecutive patients (302 males, 109 females, mean age 59 +/- 15) who successfully underwent percutaneous angioplasty (PA) and application of an intravascular stent (378 coronary, 33 vascular). The arterial closure system consists of a small absorbable anchor and a collagen pad connected to a suture thread which, at the end of the procedure, is positioned by percutaneous introduction at the site of the femoral puncture. All the patients studied received long-term platelet anti-aggregant therapy (ticlopidine 500 mg/day and ASA 150 mg/day) for 3D4 days before and for one month after the procedure, and an anticoagulant regimen of heparin sodium administered via intravenous bolus (10,000 IU) during the procedure, followed by subcutaneous heparin calcium (12,500 IU/day) for 21 days. Thirteen patients were treated intravenously with 10 mg abciximab and seven received pre-procedure coumadin. The ACT when the hemostasis system was positioned was 355 +/- 43 seconds. Successful hemostasis was reached in more than 95% of the patients (394/411 pts., 95.86%). In 17 (4.14%) of the 411 patients studied, the system failed; nine (2.19%) of these were attributed by the operator to a failure of the positioning device procedure, and the remaining 8 (1.95%) were attributed to a malfunction of the system. Overall complications were observed in 23/411 (5.6%) of the patients (pts) studied; eighteen were minor non-surgical hemorrhagic complications (bleeding and/or hematoma) which occurred primarily in the first 4 hours. In 4 cases (1%) vascular surgery was necessary for femoral pseudoaneurysm repair (2 pts) and femoral hematoma (2 pts). One patient (0.24%) complained of severe claudication related to a severe stenosis in the femoral artery caused by a malpositioning of the anchor. This patient was successfully treated with balloon angioplasty and stenting of the femoral artery. The average time to early mobilization was 9 hours, and all the patients without complications were completely mobile within 12 hours after the procedure; 380/411 (92.46%) of the patients were discharged 18D24 hours after percutaneous angioplasty. The second purpose of our study was to compare data from 411 consecutive patients treated with the Angio-Seala device after coronary and vascular angioplasty and stenting (Angio-Seal group), to a group of 387 consecutive patients where the femoral arterial hemostasis was obtained using manual compression after coronary angioplasty and stenting (manual compression group). We found significant differences (p < 0.01) in the most important elements concerning general patient management after the interventional procedure, with excellent improvements using the Angio-Seal device, including: successful hemostasis (95.86% vs. 88.37%); reduction of non-surgical hematomas (1.22% vs. 4.65%); reduction of surgical hematomas (0.49% vs. 2.84%); mobilization time (9 +/- 3 hours vs. 19 +/- 8 hours); and discharge within 18D24 hours (92.46% vs. 0.00%).     

Incidence of thrombocytopenia following coronary stent placement using abciximab plus clopidogrel or ticlopidine.

The incidence of thrombocytopenia with ticlopidine and clopidogrel when used in conjunction with abciximab has not been systematically addressed. We evaluated the rate of thrombocytopenia in patients undergoing intracoronary stent implantation receiving bolus plus infusion of abciximab and either ticlopidine or clopidogrel. We noted an incidence of 24% with the combination of 300-mg clopidogrel and abciximab. Other doses of ticlopidine (250 and 500 mg) and clopidogrel (75 mg) did not result in a statistically significant increase in thrombocytopenia over that of the 2.5%-5.2% reported incidence with abciximab alone. Length of hospital stay was 2.3 vs. 6.4 days in those developing thrombocytopenia (P = 0.06). Four (25%) developed thrombocytopenia requiring blood transfusion. Eight (50%) had no sequelae. The combination of 300-mg clopidogrel and abciximab results in a significant increase in the incidence of thrombocytopenia. This is an important clinical observation that merits further study.     

Comparison of antiplatelet effect of loading dose of clopidogrel versus abciximab during coronary intervention.

Randomized clinical trials have evidently shown that the addition of thienopyridines or abciximab to standard aspirin results in a significant reduction of ischaemic complications after coronary stent implantation. A head-to-head comparison of these antithrombotic drug regimens during coronary intervention is, however, lacking, and this was the main aim of the present study. Thirty-nine patients with angina pectoris who were scheduled for coronary stent implantation were assigned to either group 1 (160 mg aspirin + 500 mg ticlopidine post-stent), group 2 (160 mg aspirin + abciximab + 500 mg ticlopidine post-stent) or group 3 (160 mg aspirin + loading dose (375/450 mg) clopidogrel pre-stent and 75 mg clopidogrel post-stent). A loading dose of 450 mg clopidogrel was found to be more effective than the standard loading dose of 375 mg. Platelet aggregation induced by 4 micromol/l adenosine diphosphate (ADP) was assessed in samples collected before intervention and 10 min, 4 h and 20 h after intervention. Before intervention, a moderate antiplatelet effect because of aspirin intake was observed (ADP aggregation level, +/- 50%) in all study groups. After intervention, platelet aggregation tended to be enhanced in group 1 while it was strongly inhibited in the groups pre-treated with clopidogrel or abciximab: ADP induced an aggregation level early after intervention of 60 +/- 12% in group 1 (ticlopidine post-stenting) versus 30 +/- 10% in group 3 (loading dose clopidogrel) versus 3 +/- 6% in group 2 (abciximab). Abciximab achieved a more complete inhibition of aggregation than clopidogrel (P = 0.007). The overall complication rate was low with only one major bleeding and one death due to side-branch occlusion with re-infarction occurring, both in the abciximab group. Platelet aggregation during coronary intervention is strongly inhibited by both abciximab and by high loading dose of clopidogrel. Although abciximab showed a stronger antiplatelet effect than clopidogrel, it remains to be established whether this ex vivo superiority of abciximab also translates into an overall clinical benefit in patients with elective stent implantation.     

Differential benefits and outcomes of tirofiban vs abciximab for acute coronary syndromes in current clinical practice

Little comparative data exist for glycoprotein IIb/IIIa inhibitors in acute coronary syndromes (ACS). Two hundred twenty-eight patients were studied: 114 received tirofiban (TI) and 114 received abciximab (AB) for either unstable angina (UA) or myocardial infarction (MI). All patients received aspirin, heparin, and ticlopidine or clopidogrel. Baseline characteristics were similar between the 2 groups for admitting diagnosis (UA vs MI), age, gender, ejection fraction, diabetes mellitus, prior coronary artery disease, prior myocardial infarction (MI), prior bypass surgery, hypertension, congestive heart failure, hyperlipidemia, MI type (Q vs non-Q), or location. Drug administration time (mean) was 13 hours (AB) and 24 hours (TI). All AB was administered in the catheterization laboratory as compared to TI (34% in laboratory and 66% before laboratory). More AB patients received angioplasty or stent (92% vs 80%, p = 0.008) while more TI patients had CABG (10% vs 3%, p = 0.027). In-hospital complications including death, MI, urgent revascularization, cerebrovascular accidents or transient ischemic attacks, and access site bleeding were similar (p = NS). Multivariate predictors of events (odds ratios) were prior coronary artery bypass graft (2.3), diabetes (1.7), and prior percutaneous transluminal coronary angioplasty (1.7), but not the agent used. Over a mean follow-up of 13 months, the individual endpoints of death, MI, revascularization, or hospitalization were similar for both groups. The AB patients had improved freedom from revascularization (100% vs 81%, p = 0.015) in an emergent setting and TI patients had improved freedom from revascularization (93% vs 77%, p = 0.038) with elective procedures. Tirofiban and abciximab appear effective and safe when used for ACS when recommended dosing and precautions are followed. Major adverse outcomes are rare and bleeding complications uncommon.     

Peripheral vascular complications after conventional and complex percutaneous coronary interventional procedures.

To determine whether complex cardiovascular interventional procedures (including coronary stent implantation, directional atherectomy, aortic valvuloplasty, and the use of an intraaortic balloon pump or cardiopulmonary bypass support) are associated with an increased likelihood of vascular access site complications, 2,400 consecutive cardiac catheterization procedures were prospectively screened over a 12-month study period. Complications occurred in 35 patients after 39 procedures (1.6%) and included the need for vascular surgical repair (17 patients), blood transfusion (28 patients) and systemic antibiotic therapy (7 patients). The incidence of complications after 1,519 diagnostic studies was 0.6%, after 698 conventional coronary balloon angioplasties 2.6%, and after 183 complex interventions 6.0% (p less than 0.0001); 43% of the complications occurred after procedures of greater than 2 hours' duration and 14% occurred in patients in whom arterial sheaths remained in situ for greater than 24 hours. Detailed demographic and procedural characteristics were compared between the 35 patients with vascular complications and 150 patients randomly drawn from a computerized database of the uncomplicated procedures performed during the screening period. By univariate analysis with correction for multiple comparisons, variables predicting the likelihood of vascular complications included: periprocedural use of heparin (p less than 0.001) or fibrinolytic therapy (p less than 0.001), arterial sheath size greater than or equal to 8Fr (p less than 0.001), patient age greater than or equal to 65 years (p = 0.01), and the presence of peripheral vascular disease (p = 0.03). The results of this study suggest that the overall incidence of access site complications is low but increases with the use of complex cardiovascular interventional procedures.(ABSTRACT TRUNCATED AT 250 WORDS)     

Early deambulation following cardiac catheterization by the use of 6 Fr Angio-Seal, a new hemostatic percutaneous puncture closure device]

INTRODUCTION AND OBJECTIVES: Efficacy of the hemostatic puncture closure 8 Fr Angio-Seal device for percutaneous puncture closure after a catheterism has been previously demonstrated, but the experience provided has been obtained with 8 Fr devices. At present the device has been modified and its size reduced to 6 Fr. In this pilot study we evaluate the efficacy of the new hemostatic 6 Fr Angio-Seal device and its safety when early deambulation post-diagnostic and/or therapeutic catheterization is established. PATIENTS AND METHODS: Prospective study of 150 consecutive patients randomized either for application of the 6 Fr Angio-Seal device (group A; n = 75), in which early ambulation was indicated, or manual compression (group B; n = 75), with ambulation 12 h after cardiac catheterization. Basal data, including clinical and angiographic characteristics and previous treatment with heparin and platelet aggregation inhibitors were similar in both groups. RESULTS: The time of hemostasia was significantly shorter in group A than in group B (118 +/- 210 s in A vs 1320 +/- 370 s in B; p (3/4) 0,001), and with early ambulation (3,1 +/- 0,4 h in A vs 12,3 +/- 3,1 h in B; p (3/4) 0,001) no local complications were observed. CONCLUSIONS: The 6 Fr Angio-Seal hemostatic device diminished the hemostasia time and early ambulation could be achieved. In this pilot study no complications due to early movilization were observed, but the safety of the new hemostatic device after diagnostic or therapeutic catheterizations needs to be evaluated in greater series.     

Practices and complications of vascular closure devices and manual compression in patients undergoing elective transfemoral coronary procedures

Femoral arterial puncture is the most common access method for coronary angiography and percutaneous coronary interventions (PCIs). Access complications, although infrequent, affect morbidity, mortality, costs, and length of hospital stay. Vascular closure devices (VCDs) are used for rapid hemostasis and early ambulation, but there is no consensus on whether VCDs are superior to manual compression (MC). A retrospective review and nested case-control study of consecutive patients undergoing elective transfemoral coronary angiography and PCI over 3 years was performed. Hemostasis strategy was performed according to the operators' discretion. Vascular complications were defined as groin bleeding (hematoma, hemoglobin decrease ≥3 g/dl, transfusion, retroperitoneal bleeding, or arterial perforation), pseudoaneurysm, arteriovenous fistula formation, obstruction, or infection. Patients with postprocedure femoral vascular access complications were compared to randomly selected patients without complication. Data were available for 9,108 procedures, of which PCI was performed in 3,172 (34.8%). MC was performed in 2,581 (28.3%) and VCDs (4 different types) were deployed in 6,527 procedures (71.7%). Significant complications occurred in 74 procedures (0.81%), with 32 (1.24%) complications with MC and 42 (0.64%) with VCD (p = 0.004). VCD deployment failed in 80 procedures (1.23%), of which 8 (10%) had vascular complications. VCD use was a predictor of fewer complications (odds ratio 0.52, 95% confidence interval 0.33 to 0.83). In the case-control analysis, older age and use of large (7Fr to 8Fr) femoral sheaths were independent predictors of complications. In conclusion, the retrospective analysis of contemporary hemostasis strategies and outcomes in elective coronary procedures identified a low rate of complications (0.81%), with superior results after VCD deployment. Careful selection of hemostasis strategy and closure device may further decrease complication rates.     

Systematic use of a collagen-based vascular closure device immediately after cardiac catheterization procedures in 1,317 consecutive patients.

Despite recent advances in interventional cardiology, vascular access complications continue to be a significant problem. Conventional manual compression of the femoral access site is associated with prolonged immobilization and significant patient discomfort. We investigated the performance of a collagen-based closure device applied immediately after catheterization and its complication rate in 1,317 consecutive patients undergoing cardiac catheterization or coronary angioplasty. Patients undergoing coronary angioplasty (n = 644) received more heparin than patients with diagnostic cardiac catheterization (n = 673; 9,675 +/- 1,144 IU vs. 6,419 +/- 2,211 IU; P < 0.0001). Deployment success rates of the closure device were comparable for patients undergoing diagnostic vs. interventional procedures (95.8% vs. 96.7%; P = 0.46). Complete hemostasis immediately after deployment of the device was achieved in > 90% of all patients, but was lower in the interventional group (93.7% vs. 90.6%; P = 0.05). Major complications including any vascular surgery, major bleeding requiring transfusion, retroperitoneal hematoma, thrombosis or loss of distal pulses, groin infections, significant groin hematoma, and death were observed in 0.53% of all patients, with no differences between diagnostic or interventional patients (0.62% vs. 0.45%; P = 0.953). Subgroup analysis revealed female gender as a predictor of access site complications. Systematic sealing of femoral access sites after both diagnostic and interventional procedures allows for immediate sheath removal with reliable hemostasis. The use of a collagen-based closure device is associated with a low rate of clinically significant complications.     

The safety and efficacy of an extravascular, water-soluble sealant for vascular closure: initial clinical results for Mynx.

OBJECTIVE: The purpose of this study was to evaluate the hemostatic efficacy and safety of the Mynx extravascular sealant for femoral artery closure. BACKGROUND: The Mynx device is an extra-arterial vascular closure technology utilizing a water-soluble, porous, polyethylene glycol matrix that immediately seals the arteriotomy by rapidly absorbing subcutaneous fluids and expanding in the tissue tract and then, resorbs within 30 days. METHODS: The Mynx study was a prospective, multicenter, single-arm clinical investigation conducted at five European centers. The safety and effectiveness of the Mynx device was evaluated in patients following diagnostic or interventional endovascular procedures performed through 5 Fr, 6 Fr, or 7 Fr introducer sheaths in the common femoral artery. The primary safety endpoint was the combined rate of major complications within 30 days (+/-7 days). The primary efficacy endpoints were time to hemostasis and time to ambulation. RESULTS: Patient enrollment included 190 patients with 50% having undergone diagnostic catheterization and 50% interventional procedures with a mean activated clotting time of 221 sec. One (0.5%) major vascular complication (transfusion) occurred in one patient. No device-precipitated complications associated with serious clinical sequelae were reported. Mean (+/- standard deviation) times to hemostasis and ambulation were 1.3 +/- 2.3 min and 2.6 +/- 2.6 hr, respectively. There was no significant difference in median times to hemostasis between diagnostic and interventional patients (0.5 vs. 0.6 min). CONCLUSIONS: The initial experience with the extra-arterial Mynx closure technology supports hemostatic safety and efficacy in patients undergoing diagnostic and interventional catheterization procedures.     

Use of vascular sealing devices (VasoSeal and Perclose) versus assisted manual compression (Femostop) in transcatheter coronary interventions requiring Abciximab (ReoPro)

Transcatheter coronary interventions requiring abciximab (ReoPro) are associated with vascular access site complications. Several devices have been developed to aid in the closure of the femoral arteriotomy, including collagen plug devices (VasoSeal, Angio-Seal), percutaneous suture closure (Perclose), and aids to manual compression (Femostop). In 185 patients who received abciximab plus aspirin and heparin for transcatheter coronary interventions, we compared femoral arteriotomy closure by three different methods: VasoSeal, Perclose, and Femostop. A composite endpoint of late complications defined as an access site-related bleed or hematoma that required blood transfusion or an extended hospital stay, pseudoaneurysm, arteriovenous fistula, arterial or venous thrombosis was compared. VasoSeal was initially successful in 41/52 patients (78.8%). The 11 patients who failed to have adequate hemostasis with VasoSeal required manual compression aided by Femostop, but had no late complications. There was one access site infection and one fatal retroperitoneal hematoma unrelated to the vascular access site (surgically explored). There were no late complications. Perclose was successful in 48/56 patients (85.7%). One Perclose failure required surgical repair for an extensive arteriotomy. The other Perclose failure required manual compression aided by Femostop, but had no late complications. There were no access site infections requiring intravenous antibiotics. There was one retroperitoneal bleed that extended the patient's hospital stay and for which a blood transfusion was required. Femostop was successful in 77/77 patients (100%). There were no infections. Late complications occurred in four patients. These included three episodes of bleeding or hematomas requiring blood transfusion, and one pseudoaneurysm. Conclusion: In patients receiving abciximab in addition to aspirin and heparin, VasoSeal and Perclose are at least as safe as Femostop when used to achieve homeostasis after sheath removal. VasoSeal and Perclose have a significantly lower initial rate of successful hemostasis than Femostop. The numbers of late complications between the VasoSeal, Perclose, and Femostop groups were not significantly different. In those patients in whom VasoSeal or Perclose failed, no late complications occurred. Access site infections were no different between VasoSeal, Perclose, and Femostop. Cathet. Cardiovasc. Intervent. 47:143–147, 1999. © 1999 Wiley-Liss, Inc.     

Vascular complications associated with arteriotomy closure devices in patients undergoing percutaneous coronary procedures: a meta-analysis

OBJECTIVES: This study was designed to assess the safety of arteriotomy closure devices (ACDs) versus mechanical compression by meta-analysis in patients undergoing percutaneous transfemoral coronary procedures. BACKGROUND: Although ACDs are widely applied for hemostasis after percutaneous endovascular procedures, their safety is controversial. METHODS: Randomized, case-control, and cohort studies comparing access-related complications using ACDs versus mechanical compression were analyzed. The primary end point was the cumulative incidence of vascular complications, including pseudoaneurysm, arteriovenous fistula, retroperitoneal hematoma, femoral artery thrombosis, surgical vascular repair, access site infection, and blood transfusion. RESULTS: A total of 30 studies involving 37,066 patients were identified. No difference in complication incidence between Angio-Seal and mechanical compression was revealed in the diagnostic (Dx) setting (odds ratio [OR] 1.08, 95% confidence interval [CI] 0.11 to 10.0) or percutaneous coronary interventions (PCI) (OR 0.86, 95% CI 0.65 to 1.12). Meta-analysis of randomized trials only showed a trend toward less complications using Angio-Seal in a PCI setting (OR 0.46, 95% CI 0.20 to 1.04; p = 0.062). No differences were observed regarding Perclose in either Dx (OR 1.51, 95% CI 0.24 to 9.47) or PCI (OR 1.21, 95% CI 0.94 to 1.54) setting. An increased risk in complication rates using VasoSeal in the PCI setting (OR 2.25, 95% CI 1.07 to 4.71) was found. The overall analysis favored mechanical compression over ACD (OR 1.34, 95% CI 1.01 to 1.79). CONCLUSIONS: In the setting of Dx angiography, the risk of access-site-related complications was similar for ACD compared with mechanical compression. In the setting of PCI, the rate of complications appeared higher with VasoSeal.