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.     

A randomized comparison of a percutaneous suture device versus manual compression for femoral artery hemostasis after PTCA

BACKGROUND: The prolonged bed rest following femoral sheath removal after PTCA is a source of discomfort for the patient. We designed a randomized study to evaluate the efficacy and safety of an arterial suture device developed to percutaneously close the vascular access site after PTCA, allowing immediate sheath removal and early ambulation, compared to manual compression. METHODS: After successful PTCA, patients were randomized to manual compression or immediate femoral percutaneous closure. Exclusion criteria were arteritis, age > 80 years and > 3 previous femoral punctures on the same side. The two-needle device was used for the 6F sheath removal and the four-needle device for the 8F sheath. Ambulation was allowed 4 hours after the arterial suture. RESULTS: One hundred and sixty-seven patients (59 +/- 10 years, 81% males) were randomized to suture device (n = 91) or to manual compression (n = 76). The two groups were similar in terms of age, sex, size of sheath, number of patients with stent implantation (62 vs 61%), procedural anticoagulation. Procedural duration was 8 +/- 6 minutes with percutaneous suture versus 25 +/- 11 minutes with manual compression (P < 0.0001). Procedural success with percutaneous suture was 93% whereas six technical failures were treated with prolonged manual compression. Nonsurgical hematoma occurred in five patients (5%) with the suture device and in two (3%) with manual compression with no need for blood transfusion (P = NS). Uneventful blood oozing occurred in 11 patients (12%) with percutaneous suture and in only 2 (3%) with manual compression (P < 0.06). The tolerance of the hemostasis procedure and the length of post-procedure hospital stay (40 +/- 32 hours) were similar in the two groups. CONCLUSION: Percutaneous suture of the femoral artery, allows immediate closure of femoral puncture sites after PTCA, without increasing the incidence of vascular complications. The use of this device should allow earlier discharge and subsequent cost savings.     

Safety and efficacy of staple-mediated femoral arteriotomy closure: results from a randomized multicenter study.

BACKGROUND: Mechanical closure of percutaneous femoral arteriotomies following catheter based procedures remains problematic. METHODS: The EVS closure device is the first to utilize a staple to effect arteriotomy closure and was compared to manual compression following sheath removal in a 362 patient randomized (2:1 to device) multicenter trial. As pre-specified, one half of the patients underwent coronary intervention. RESULTS: Time to hemostasis was significantly reduced in the EVS group for both diagnostic (3.3 +/- 2.6 vs. 19.3 +/- 5.7 minutes; p < 0.001) and interventional procedures (5.5 +/- 5.1 vs. 22.3 +/- 9.9 minutes; p < 0.0001). Time to ambulation was similarly reduced in the EVS group following diagnostic (2.4 +/- 3.3 vs. 6.0 +/- 5.2 hours; p < 0.001) and interventional procedures (3.4 +/- 4.5 vs. 7.6 +/- 7.0 hours; p < 0.001). The incidence of major complications was similar between the EVS and manual compression groups at discharge (0.4% vs. 1.7%; p = NS) and at 30 day follow-up (0.4% vs. 2.5%; p = NS). CONCLUSION: Compared to manual compression, the EVS device provides a safe and effective method of femoral artery closure.     

Arterial puncture site management after percutaneous transluminal procedures using a hemostatic wound dressing (Clo-Sur P.A.D.) versus conventional manual compression: a randomized controlled trial.

PURPOSE: To investigate the efficacy and safety of a novel hemostatic wound dressing designed for rapid hemostasis at arterial puncture sites. METHODS: Over a 15-month period, 209 consecutive patients were randomized to conventional manual compression (n=105) or the use of the Clo-Sur P.A.D. hemostatic device (n=104) after removal of the sheath. Puncture-related and device-related complications, time to hemostasis, time to ambulation, and patient and physician discomfort were recorded. RESULTS: In 209 patients, 21 (10.0%) puncture-related complications were observed, including 11 (5.3%) pseudoaneurysms, 9 (4.3%) hematomas, and 1 (0.5%) major bleeding complication. There was no significant difference (p=0.36) in complications between the hemostatic device (9/104, 8.7%) and the conventional group (12/105, 11.4%). In the hemostatic device group compared to the conventional group, respectively, the average time to hemostasis (13.6 versus 20.3 minutes; p<0.001), time to ambulation (6.5 versus 17.4 hours, p<0.001), patient discomfort (VAS 2.1 versus 4.7, p<0.001), and physician discomfort (VAS 3.8 versus 5.2, p<0.001) were significantly lower. Twenty (19%) sheath removals in the hemostatic device group were classified as a technical failure of the device. CONCLUSION: The use of this hemostatic wound dressing for arterial access site management after percutaneous vascular procedures significantly reduced the time to hemostasis, enabled early mobilization, and reduced patient discomfort without increasing the risk for complications compared to conventional manual compression. A high rate of technical failures, however, warrants further improvement before routine use can be recommended.     

Suture-mediated closure of the femoral access site after cardiac catheterization: results of the suture to ambulate aNd discharge (STAND I and STAND II) trials

Despite advances in other aspects of cardiac catheterization, manual or mechanical compression followed by 4 to 8 hours of bed rest remains the mainstay of postprocedural femoral access site management. Suture-mediated closure may prove to be an effective alternative, offering earlier sheath removal and ambulation, and potentially a reduction in hemorrhagic complications. The Suture To Ambulate aNd Discharge trial (STAND I) evaluated the 6Fr Techstar device in 200 patients undergoing diagnostic procedures, with successful hemostasis achieved in 99% of patients (94% with suture closure only) in a median of 13 minutes, and 1% major complications. STAND II randomized 515 patients undergoing diagnostic or interventional procedures to use of the 8Fr or 10Fr Prostar-Plus device versus traditional compression. Successful suture-mediated hemostasis was achieved in 97.6% of patients (91.2% by the device alone) compared with 98.9% of patients with compression (p = NS). Major complication rates were 2.4% and 1.1%, and met the Blackwelder's test for equivalency (p <0.05). Median time to hemostasis (19 vs 243 minutes, p <0.01) and time to ambulation (3.9 vs 14.8 hours, p <0.01) were significantly shorter for suture-mediated closure. Suture-mediated closure of the arterial puncture site thus affords reliable immediate hemostasis and shortens the time to ambulation without significantly increasing the risk of local complications.     

经皮血管缝合器的安全性和疗效观察

目的　评估病人拔鞘管后应用经皮血管缝合器与人工压迫止血的安全性和疗效的比较。主要观察终点包括术后可下床走动时间与血管并发症。方法　 10 5例病人 (男、80例 ;女 2 5例 ,平均年龄 65 .7± 12 .3岁 )在行心导管术后 ,随机分为人工压迫组 ( 组 ,5 3例 )和股动脉穿刺点经皮血管缝合器组 ( 组 ,5 2例 ) ,在术后即刻应用经皮血管缝合器和依病人抗凝水平行人工压迫止血 ,观察止血时间、下床走动时间和并发症。结果　应用经皮血管缝合器组与人工压迫组止血时间 ( 7.5± 3.0和 19.5± 6.5分 ,P<0 .0 0 1)与下床走动时间 ( 4.5± 2 .0和 16.5± 5 .0小时 ,P<0 .0 0 1)有显著缩短 ,血管并发症 (有 6人伤口渗血和血肿 >4cm, 组 7.5 % ( 4/ 5 3) , 组 3.8% ( 2 / 5 2 ) ,两组无显著差异。有 4例病人首次应用缝合器止血失效 ,因为病人的缝合血管周围病变及皮肤组织凹陷 ,有一例缝合管拆除时缝合线断接 ,首次成功率达 94% ( 48/ 5 2 ) ,失败两例再用缝合器缝合获得成功 ,总成功率达 96% ( 5 0 /5 2 )。在 组有 1例病人在血管成形术 3天后出现再次急性心肌梗死 ,给予静脉 (尿激酶 )溶栓后于穿刺伤口再出血而需压迫止血 1小时。结论　表明经皮血管缝合器应用的安全性优于人工压迫组 ,缩短了止血与下床走动时间     

A randomized controlled trial on the hemostasis of femoral artery using topical hemostatic agent

Objective: Evaluation of the effect of using a topical hemostatic agent named "ChitoHem(?)" on different factors on patients undergoing diagnostic coronary angiography. Methods: The present blind, randomized, controlled study included 124 patients randomly divided into 2 groups. In the treatment group following femoral sheath removal, ChitoHem(?) powder and in the control group conventional hemostatic procedure was applied. Results: In the treatment group, time to hemostasis, ambulation, and the use of sandbag were significantly shorter compared with the control group, respectively (4.6 ± 1.3 vs 12.4 ± 4.4 minutes, 3.5 ± 2.7 vs 23.0 ± 1.73 hours and 1.6 vs 98.4%; P < .05). There were no significant differences in hematoma formation and re-bleeding between the 2 groups. Conclusion: It was exhibited ChitoHem(?) topical hemostatic powder used on treatment patients undergoing diagnostic coronary angiography was statistically superior at reducing the time to hemostasis and ambulation as well as the use of sandbags compared with manual compression in control group.     

经皮血管缝合器与人工压迫法对股动脉拔管术后止血效果的比较

比较病人拔鞘管后应用经皮血管缝合器与人工压迫止血的安全性和疗效。 1 2 5例病人 (男 86例、女 39例 ,年龄 65 .7± 1 2 .3岁 ) ,在行心导管术后 ,分为人工压迫组 [Ⅰ组 ,63例 ,其中分为冠状动脉 (简称冠脉 )造影 (CAG)组35例 (IA) ,冠脉介入治疗术组 2 8例 (IB) ]和股动脉穿刺点经皮血管缝合组 [Ⅱ组 ,62例 ,CAG组 35例 (ⅡA) ,冠脉介入治疗术组 2 7例 (ⅡB) ]。在术后即刻应用经皮血管缝合器和依病人抗凝水平行人工压迫止血 ,观察止血时间 ,平卧时间和并发症。结果 :与人工压迫止血组时间比较 ,经皮血管缝合组止血时间和平卧时间有显著缩短。有 4例病人首次应用缝合器止血失效 ,首次成功率达 91 % ( 5 8/62 ) ;失败 2例 ,再用缝合器缝合获得成功 ,总成功率达96% ( 60 /62 )。在ⅠB组有 1例病人在血管成形术 3天后出现再次急性心肌梗死 ,给予静脉 (尿激酶 )溶栓后于穿刺伤口再出血而需压迫止血 1h。结论 :经皮血管缝合器应用的安全性优于人工压迫组 ,缩短了止血与下床走动时间     

Early ambulation after diagnostic cardiac catheterization: a 4 French study

This study is intended to test whether the use of new 4 French (Fr) catheters can safely eliminate the need for supine bed rest and allow earlier ambulation while decreasing groin site complications and patient discomfort. Diagnostic left heart catheterization was performed using 4 Fr catheters via the femoral approach in 100 consecutive patients. After femoral sheath removal, the mean compression time with a mechanical compression device was 16.07 +/- 3.19 minutes. Mean manual compression time was 18.3 +/- 5.7 minutes. Ninety-eight patients were able to sit up 30 degrees immediately after hemostasis was achieved. The mean ambulation time was 2.18 +/- 0.71 hours. There were no major vascular complications. Four patients developed a small area (2.5-5 cm) of ecchymosis at the femoral arterial puncture site. The study demonstrated that upper body elevation and early ambulation are safe as soon as hemostasis is achieved after 4 Fr cardiac catheterization.     

First experience with the use of a clip device for closure of arterial approach after endovascular treatment of coronary arteries

Aim of the present study was assessment of the StarClose Vascular Closure System - novel device for mechanical closure of femoral artery puncture site. We included in this study 29 patients in whom after procedure of endovascular treatment puncture site was closed with the given device. Control group comprised 34 patients in whom hemostasis was conducted by way of manual compression of puncture site according to standard technique. Femoral artery was clipped immediately after completion of the stenting procedure irrespective of the last result of activated partial thromboplastin time measurement. Success of the use of the StarClose was 100%. Activation of a patient was undertaken substantially earlier compared with the group of manual hemostasis. Sitting up in bed was performed in 2 hours after completion of hemostasis procedure compared with 16 hours in control group, walking within ward was started in 3.5 hours compared with 17 hours in control group ( < 0.0001 in both cases). Duration of the procedure of hemostasis was substantially smoller in the group of closing device compared with the group of manual hemostasis (1.7 and 23 min, respectively). With this no complications from the site of puncture were observed in the group of closing device. In the group of manual hemostasis one patient (2.9%) had hematoma nor requiring special treatment and in one more patient (2.9%) after violation of bed regimen minor bleeding occurred from puncture site (was eliminated by additional manual compression for 20 min). Total number of complications in the group of manual compression was 5.8%. Thus compared with traditional manual hemostasis. The use of StarClose clip device allows to activate patients after endovascular treatment substantially earlier.     

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

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

A prospective, randomized trial of topical hemostasis patch use following percutaneous coronary and peripheral intervention

The use of topical hemostasis patches has grown rapidly despite a paucity of evidence supporting their clinical utility. We performed a randomized, controlled trial to assess the efficacy of a topical hemostasis patch as a means to accelerate vascular hemostasis following percutaneous intervention. One hundred fifty (150) patients undergoing coronary or peripheral intervention through a 6 Fr femoral arterial sheath were randomized to sheath removal with either: (1) manual pressure and adjunctive use of a patch incorporating a polysaccharide based procoagulant material (SafeSeal Patch, Possis Medical Inc.); or (2) conventional manual pressure alone. Sheaths were removed when the activated clotting time (ACT) fell to < or = 250 seconds. Patients ambulated 2 hours after hemostasis was achieved. Time to hemostasis (duration of compression required until cessation of bleeding following sheath removal) was significantly lower in the hemostasis patch arm (11.8 +/- 3.6 vs. 13.8 +/- 5.8 minutes; p = 0.02). Attainment of hemostasis in < 15 minutes was also more likely among patients randomized to the hemostasis patch rather than manual compression alone (odds ratio = 2.5; 95% confidence intervals 1.2, 5.1; p = 0.014). The median time to ambulation (total duration from the end of the interventional procedure to ambulation) was significantly reduced among patients in the hemostasis patch arm (2.8 vs. 3.8 hours; p = 0.03). Bleeding complications were uncommon and did not differ between the study arms. In conclusion, this trial supports the concept that the polysaccharide-based SafeSeal Patch enhances access site hemostasis following endovascular intervention.     

Assessment of the safety and efficacy of the DUETT vascular hemostasis device: final results of the safe and effective vascular hemostasis (SEAL) trial

Objective We sought to determine the safety and efficacy of the novel DUETT vascular hemostasis device in comparison with standard manual compression after diagnostic and interventional coronary procedures. Background Vascular hemostasis devices are increasingly used to improve patient comfort and speed mobilization after coronary and peripheral vascular procedures. Currently available devices have certain limitations, however. Methods At 16 clinical sites, 630 patients who underwent diagnostic or interventional coronary procedures were randomized 5:3 to the DUETT sealing device or standard manual compression. The primary study end points were time to hemostasis and ambulation and the incidence of major vascular complications at 30 days. Results Time to hemostasis from the completion of the procedure (catheter removal; median) was 14 minutes (interquartile range [IQR], 10, 17 minutes) in the DUETT group and 195 minutes (IQR, 46, 351 minutes) in the standard compression group (P <.001), and time from sheath removal (median) was 7 minutes (IQR, 6, 8 minutes) and 20 minutes (IQR, 15, 30 minutes) for the 2 groups, respectively (P <.001). Time to ambulation from catheter removal (median) was 338 minutes (IQR, 223, 526 minutes) in the DUETT group and 705 minutes (IQR, 400, 1120 minutes) in the standard compression group (P <.001). Major complications occurred in 3.6% of the DUETT group and 1.7% of the standard compression group (P = .22), with a diminishing risk of complications in the DUETT group as experience was accrued. Similar benefits from DUETT use were seen in patients who underwent both diagnostic and interventional procedures. Conclusion The DUETT sealing device allows immediate arterial sheath removal after both diagnostic and interventional procedures, dramatically reducing time to hemostasis and patient ambulation without compromising patient safety in comparison with standard compression techniques. (Am Heart J 2002;143:612-9.)     

Comparison of costs and safety of a suture-mediated closure device with conventional manual compression after coronary artery interventions.

The aim of this study was to assess costs and safety of immediate femoral sheath removal and closure with a suture-mediated closure device (Perclose, Menlo Park, CA) in patients undergoing elective (PCI). A total of 193 patients was prospectively randomized to immediate arterial sheath removal and access site closure with a suture-mediated closure device (SMC; n = 96) or sheath removal 4 hr after PCI followed by manual compression (MC; n = 97). In the SMC group, patients were ambulated 4 hr after elective PCI if hemostasis was achieved. In the MC group, patients were ambulated the day after the procedure. In addition to safety, total direct costs including physician and nursing time, infrastructure, and the device were assessed in both groups. Total direct costs were significantly (all P < 0.001) lower in the SMC group. Successful hemostasis without major complication was achieved in all patients. The time to achieve hemostasis was significantly shorter in the SMC group (7.1 +/- 3.4 vs. 22.9 +/- 14.0 min; P < 0.01) and 85% of SMC patients were ambulated on the day of intervention. Suture-mediated closure allows a reduction in hospitalization time, leading to significant cost savings due to decreased personnel and infrastructural demands. In addition, the use of SMC is safe and convenient to the patients.     

Percutaneous suture of femoral artery after diagnostic coronary angiography

Complete local haemostasis after femoral artery catheterization can be performed using percutaneous suture devices. To evaluate efficacy and safety of these systems after diagnostic coronary angiography, we performed a randomized study where patients were treated either with a manual compression (group C) or a percutaneous suture (group T). Fifty patients were included in each group. Patients in group C had to rest at bed during 24 hours while patients in group T had to stand up and walk immediately after complete haemostasis was obtained. All angiographies were performed using a 6 F sheath. All patients had a clinical evaluation and an echography 24 hours after the procedure and all were reached by phone call at 15 days. Both groups were similar in term of age, sex ratio, diabetes, height and weight. Complete haemostasis was obtained in 20 +/- 6 mn in group C and in 6 +/- 10 mn in group T (p < 0.001). Device technical success rate in group T was 90%; 70% of patients walked immediately down the X ray table and 90% before the 4 hours. Ambulation delay was 24 +/- 5 hours in group C and 5 +/- 9 hours in group T (p < 0.0001). Clinical and echographic complications rate were similar in both groups (8%). There was no post procedure complication in group T (especially after ambulation) nor at the phone call. CONCLUSION: Femoral artery percutaneous suture after diagnostic coronary angiography is as safe and working than manual compression. It allows an immediate mobilization and ambulation, far earlier than compression.     

冠状动脉介入术后血管缝合的血管并发症分析

目的 分析冠状动脉介入术后Angioseal血管缝合器机械止血和人工压迫止血的血管并发症发生率。方法 947例冠状动脉介入诊治病例，179例术后使用Angioseal血管缝合器止血（机械组），另外768例进行人工压迫止血（人工组），比较二组的止血时间、制动时间和血管并发症发生率。结果 机械组显著缩短止血时间和制动时间(P<0.01)，但其与人工组的血管并发症发生率差异无统计学意义（P>0.05）。结论 使用Angioseal血管缝合器能显著缩短止血时间和制动时间，但不能减少股动脉穿刺并发症的发生率，不推荐介入术后常规使用机械止血装置。     

Clinical effectiveness of the Prostar XL suture-mediated percutaneous vascular closure device following PCI: results of the Perclose AcceleRated Ambulation and DISchargE (PARADISE) Trial

BACKGROUND: The Prostar XL is a hemostasis device designed to percutaneously close the arterial puncture site with two nonabsorbable sutures. The Early Discharge and Economical effectiveness study for New hemostasis device (EDEN) trial, which was performed in Japan, showed that the Prostar XL device shortened time to hemostasis, time to ambulation and the average length of hospital stay, and decreased local vascular complications. However, the ooze of blood from the puncture site incision requires relatively longer time to ambulation. OBJECTIVES: The Perclose AcceleRated Ambulation and DISchargE (PARADISE) trial was performed to assess the effectiveness of the Prostar XL device on patient comfort, shortened time to ambulation and discharge from hospital by minimizing the oozing problem. METHODS: This multicenter, non-randomized registry was designed to compare times to hemostasis, ambulation and discharge, as well as the incidence of peripheral vascular complications in Prostar XL patients with the conventional manual compression group in the EDEN trial. Hydrochloride lidocaine containing 1% epinephrine was used as local anesthesia to reduce blood oozing. RESULTS: Between September 1999 and March 2000, a total of 109 patients were enrolled in this study. The closure device was successfully placed in 108 of 109 attempts. Time to hemostasis was significantly less than with the conventional manual compression group in the EDEN trial. Times to ambulation and discharge were significantly less than with the Prostar XL and conventional manual compression groups in the EDEN trial. CONCLUSION: We conclude that the Prostar XL device plus hydrochloride lidocaine containing 1% epinephrine as local anesthesia appears to be a safe and effective method to achieve hemostasis, and to improve times to ambulation and discharge after interventional procedures.     

Immediate femoral sheath removal after 6 French routine coronary angioplasty with a weight-adjusted low-dose heparin: results of a prospective registry

This study assesses the feasibility and safety of immediate sheath removal after coronary angioplasty with the use of 6 French (Fr) guiding catheters by the femoral route and weight-adjusted low-dose heparin (100 IU/kg). We prospectively evaluated such a strategy among a single-center cohort of 261 consecutive patients undergoing routine percutaneous transluminal coronary angioplasty (PTCA). Immediate sheath withdrawal was performed in cases when post-PTCA residual coronary stenosis was less than 30%, with or without stenting. One hundred eighty-two (70%) of the enrolled patients were eligible for immediate sheath removal. When compared with non-eligible patients (sheath removal 4 hours or more post-PTCA), we observed a reduction of hematoma occurrence (15% vs. 30%; p < 0.01), time to manual hemostasis of the puncture site (13.8 +/- 7 vs. 19.7 +/- 12 minutes; p < 0.0001), and time to hospital discharge (2.2 +/- 1.9 vs. 2.8 +/- 1.8 days; p < 0.02), while ischemic event rate was similar (1 vs. 2 non-Q wave myocardial infarction; 2 vs. 1 repeat PTCA for out-of-lab acute vessel closure). In conclusion, a good angiographic result at completion of PTCA using a 6 Fr sheath, even without stenting, makes an immediate sheath removal feasible at no increased risk and with a potential reduction in minor bleeding complications.     

Safety and efficacy of a 6 French perclose arterial suturing device following percutaneous coronary interventions: a pilot evaluation

BACKGROUND: Arterial access site management after percutaneous coronary intervention (PCI) is a matter of increasing importance in this era of potent antiplatelet pharmacotherapy. We evaluated the safety and efficacy of a 6 French (Fr) Perclose suturing device in achieving rapid hemostasis of the access site after PCI and thus improving patient comfort. METHODS: The 6 Fr Perclose (Prostar) device consists of a suture-based closure device delivered via introducer sheath designed for suturing of the arteriotomy puncture site. Over a 3-month period, the device was used in 48 consecutive PCI treated patients (age, 62 13 years; 70% male; 44% post myocardial infarction) and in-hospital groin complication rate was compared to 48 consecutive patients (age, 64 12 years; 64% male; 33% post myocardial infarction) who had manual compression hemostasis. RESULTS: Antiplatelet glycoprotein IIb/IIIa antagonists were used more frequently during and following the procedure in 58% of Perclose-treated patients versus 42% of the manual compression group (p = 0.019). Leg immobilization duration was 3 4 hours in all patients sutured by the device; in patients with manual compression, the sheath was removed at an average of 4.8 2.5 hours after termination of the PCI and an additional 6 hours of leg immobilization were subsequently required. No difference in overall major complication rate was found between groups (6.2% in suture-mediated patients versus 9.3% in manual compression group; p = 0.60). In 3 patients (6.2%) treated using the device, adjunctive manual compression was required in addition to groin suturing due to technical failure or residual oozing from the arteriotomy site. CONCLUSION: The 6 Fr Perclose device can be safely used to achieve rapid hemostasis and the device may hasten bed mobilization of PCI-treated patients despite frequent use of potent antiplatelet pharmacotherapy during coronary interventions.     

Effect of a closure device on complication rates in high-local-risk patients: results of a randomized multicenter trial.

Clinical trials have shown that coronary stenting is associated with a high level of complications at the access site. Arterial sealing devices have proven their efficacy in obtaining immediate hemostasis after sheath removal, in allowing early ambulation, and in improving patient comfort. However, there is no report showing a reduction of local complications related to their use. The purpose of this multicenter study was to compare randomly the efficacy of Angio-Seal versus compression methods of hemostasis in reducing the rate of access site complications after coronary angioplasty in 612 selected patients with higher risk of local events satisfying at least one of the following high-risk criteria: age > 70, previous puncture at the same site, history of hypertension, treatment with ticlopidine at least 2 days before the procedure, use of abciximab, 8 Fr access, prolonged heparin treatment after the angioplasty, and use of lytics if fibrinogen > 1 g/l. Group A (n = 306) had immediate sheath removal, Angio-Seal implantation, and cessation of bed rest 4 hr after the intervention. Group B (n = 306) had sheath removal according to local practice and cessation of bed rest 6-18 hr after the hemostasis procedure, also according to local practice. Clinical follow-up was done at 1 hr, 4 hr, 24 hr, discharge, and 7 days and a systematic color flow duplex sonography was performed to confirm diagnosis of access site complication. In group A, device deployment and immediate hemostasis were obtained in, respectively, 96.8% and 87% of patients. Time to hemostasis was shorter in group A: 5 vs. 52 min (P < 0.001). Cessation of bed rest was dramatically reduced in group A (438 +/- 450 min) vs. group B (952 +/- 308 min; P < 0.001). The cumulative rate of complications, using a composite primary endpoint, at 7 days was significantly different between the two groups: 5.9% of group A patients and 18% of group B patients (P < 0.001). This difference was mainly due to the dramatic reduction of prolonged bleeding in group A patients. Angio-Seal device use in high-local-risk patients allows immediate sheath removal and hemostasis with a reduction of local event rate despite a higher level of anticoagulation, compared to regular compression techniques, directly related to a dramatic decrease of prolonged bleeding.