超声波引导下压迫法与注射凝血酶法治疗心导管术后股动脉假性动脉瘤的比较

目的 :评价和比较超声引导下压迫法 (UGCR)和注射凝血酶法 (UGTI)治疗心导管术后股动脉假性动脉瘤 (PSA)的疗效和安全性。方法 :回顾性分析 2 1例心导管术后股动脉PSA的临床特征 ,以及序贯接受UGCR和UGTI法治疗的经过和结果。在彩色多普勒确定PSA后 ,UGCR法是用手压迫、加压包扎载瘤动脉近端和PSA颈部直至PSA瘤腔中血栓形成 ;UGTI法是超声波引导下将 18～ 2 0G针经皮穿刺使针头进入瘤腔内注射猪凝血酶。均于术后 2 4h、5～ 7d超声波复查。结果 :11例首次接受UGCR法治疗者中 4例成功 (首次成功率 36 .4 % ) ,5例接受重复压迫后有 1例成功 ,总成功率为 4 5 .5 % (5 / 11) ;UGCR治疗成功者的 5例中有 4例股动脉PSA最大直径 <2cm ,其中 2例接受抗凝剂治疗 ;在压迫中 10例有程度不等的局部不适、疼痛 ,有 8例在压迫中因局部疼痛而采用药物止痛 ,有 2例因出现血压增高、心绞痛发作而被迫放弃 ;UGCR治疗失败的 6例中 ,有 1例接受了外科手术治疗 ,5例改行UGTI治疗成功。采用UGTI治疗 15例股动脉PSA ,其中 10例首次接受UGTI治疗有 9例成功 (首次成功率 90 % ) ,6例为经重复UGTI治疗成功 ,UGTI总成功率为 10 0 %。单纯型PSA有 9例均一次性治疗成功 ,而 6例复杂型PSA需 2次或以上重复注射凝血酶。实际注射凝血酶剂     

Compression repair versus low-dose thrombin injection for the treatment of iatrogenic femoral pseudoaneurysm: a retrospective case-control study.

BACKGROUND: It has been shown that thrombin injection is a safe and effective technique for the treatment of iatrogenic femoral pseudoaneurysm. The aim of this study was to evaluate and compare the use of ultrasound-guided low-dose thrombin injections with ultrasonographically-guided compression repair in the treatment of iatrogenic femoral arterial pseudoaneurysm. METHODS: We compared two cohorts of patients treated for iatrogenic femoral pseudoaneurysm: the first included 38 patients who underwent ultrasonographically-guided compression repair as a first-step approach between January 1998 and November 2002; the second included 21 patients treated with ultrasound-guided low-dose thrombin injection between December 2002 and December 2003. RESULTS: Both groups had similar demographic characteristics and aneurysm sizes (p = 0.72). Compression was successful in 24/38 patients (63%); the 14 persistent aneurysms were surgically repaired (37%). The primary thrombin injection of a mean dose of 185+/-95 U/ml (range 100-400 U/ml) successfully obliterated all of the 21 pseudoaneurysms (success rate 100 vs 63% in the compression group, p = 0.004). Thrombosis occurred within an average of 12+/-15 s of thrombin injection. Sedation was used in 42% of the patients undergoing compression and in none of those receiving thrombin (p = 0.001). The duration of hospitalization was significantly longer in patients undergoing compression therapy (9.8+/-5.6 vs 5.6+/-1.4 days, p = 0.001). CONCLUSIONS: Ultrasound-guided low-dose thrombin injection appears to be more effective in reducing the need for surgical repair when used to treat iatrogenic femoral pseudoaneurysm, is better tolerated by the patients, and requires a shorter hospital stay.     

Therapeutic thrombin injection of pseudoaneurysms: a multicenter experience

The standard non-invasive treatment of pseudoaneurysms has been ultrasound-guided compression (UGC). Problems with UGC include pain at the site of compression, long compression times and incomplete closure. Each of these difficulties is exacerbated with large pseudoaneurysms. Recently, ultrasound-guided injection of pseudoaneurysms with thrombin has gained popularity. The goal of this study was to report a multicenter registry using this technique and in so doing detail the clinical utility and safety of this emerging procedure. The medical records of all patients diagnosed with pseudoaneurysm in the vascular laboratory who underwent thrombin injection over the past year were reviewed for patient characteristics and clinical outcome. There were 91 patients (55 male) with a mean age of 69 years. Three patients also had an arteriovenous fistula. The majority of patients were receiving one or more antiplatelet agents and/or anticoagulants. All patients underwent pseudoaneurysm injection with bovine thrombin. The mean aneurysm diameter was 3.3 cm, with a range of 1.5-6.3 cm. Successful thrombosis of the pseudoaneurysm was achieved in 89/91 (98%) of cases. Anticoagulation with heparin was used in one of the unsuccessful cases. In two cases, UGC was used to close a small active region that did not completely thrombose after thrombin injection. There were two patients who had recurrence of pseudoaneurysm the day after successful injection and thrombosis of the pseudoaneurysm. There were no local complications after injection; however, one patient suffered a pulmonary embolus that was thought to be unrelated to the procedure. In conclusion, thrombin injection for the treatment of pseudoaneurysms is safe and effective, even in patients receiving anticoagulation. This procedure should be considered as the initial therapeutic approach for peripheral pseudoaneurysms.     

Treatment of post-catheterization femoral artery pseudo-aneurysm with para-aneurysmal saline injection

Femoral artery pseudoaneurysm is a common complication associated with cardiac catheterization procedures. Ultrasound-based techniques (e.g., mechanical compression, thrombin injection) and open surgical intervention are frequently used in the management of pseudoaneurysm. The investigators report their prospective experience with a novel method for the treatment of pseudoaneurysm after cardiac catheterization using ultrasound-guided, para-aneurysmal injection of physiologic saline. Sixty-four consecutive patients with pseudoaneurysms after cardiac catheterization were treated using normal saline (0.9% sodium chloride 25 to 60 ml) injected into the tissue surrounding the tract connecting the pseudoaneurysm with the femoral artery, followed by manual pressure of short duration. In none of the patients was concomitant antithrombotic therapy (aspirin [n = 63], clopidogrel [n = 45], unfractionated or low-molecular-weight heparin [n = 23], and warfarin [n = 5]) discontinued during the closure attempt. Fifty-nine of the 64 pseudoaneurysms (92%) were successfully occluded using saline injection. In 5 patients in whom saline injection failed, the pseudoaneurysms were successfully treated with thrombin injection (n = 4) or ultrasound-guided compression (n = 1). In all 64 patients, pseudoaneurysm closure was confirmed by ultrasound at 24 hours. The procedure was very well tolerated by the patients, and no side effects or complications were noted. In conclusion, ultrasound-guided saline injection affords a simple, safe, and effective alternative treatment for the closure of postcatheterization pseudoaneurysms.     

A prospective study on ultrasound-guided compression therapy or thrombin injection for treatment of iatrogenic false aneurysms in patients receiving full-dose anti-platelet therapy

BACKGROUND: False aneurysms (FA) develop at the puncture site in up to 6% of percutaneous cardiovascular procedures. Previous management included surgery or manual compression. Recently, selective injection of thrombin has been proposed as an alternative. However, there has been no direct comparison of thrombin injection to manual compression. AIM: To study the effectiveness of manual compression compared to that of thrombin injection in patients with false aneurysms on full-dose aspirin and clopidogrel. METHODS AND PROTOCOL: All patients with a clinically suspected FA after percutaneous invasive procedures were recruited for the study. The patients were examined with color ultrasound (7.5 MHz transducer). The minimum and maximum diameters of the false aneurysm and the distance between the surface and the false aneurysm were measured online. Under local anesthesia, manual compression was applied under sonographic guidance in all patients. If compression stopped flow into the false aneurysm, manual compression was applied for a maximum of 40 min followed by compression bandage for a minimum of 12 hours. If compression failed, thrombin was injected under ultrasound guidance. RESULTS: Thirty-six patients had a FA. Their age ranged from 58 to 90 years (mean 71+/-9 years). All patients were taking aspirin (median dose 100 mg per day) and clopidogrel (median dose 75 mg per day). Additionally, 24 patients had received subcutaneous heparin (7500 to 12 500 units) or enoxaprin (0.4-1.0 ml) 3 to 12 hours before treatment. The mean width of the false aneurysm was 22.1+/-3 mm, mean length 33.6+/-35.4 mm, and mean depth 19.5+/-8.2 mm. In six patients (17%), ultrasound-guided manual compression was tolerated, succeeding after 5 to 31 minutes. Thirty patients received thrombin injections (100-1800 units, mean 880+/-470 units, median 800 units). Complete thrombosis occurred in 28 patients (93%). Surgery was performed in the other two patients. The thrombin injection was not associated with any complications. In particular, there were no peripheral vascular complications. CONCLUSION: In patients with FA taking aspirin and clopidogrel, selective thrombin injection is more effective than manual compression.     

Successful treatment of a femoral artery pseudoaneurysm mimicking a deep venous thrombosis following cardiac catheterization.

Access site pseudoaneurysms are uncommon but well-known complications of cardiac catheterization. We report the first known case of a pseudoaneurysm mimicking the presentation of a deep venous thrombosis by causing extrinsic compression of the venous system. The patient had complete resolution of the pseudoaneurysm and his symptoms following treatment with ultrasound-guided percutaneous thrombin injection.     

超声指导下压迫修复法闭合经皮导管术后股动脉假性动脉瘤

目的:总结超声指导下压迫修复法(UGCR)治疗股动脉假性动脉瘤(FAP)的疗效和安全性。方法:经股动脉穿刺法行冠状动脉介入术后发生FAP8例,男5例,女3例,年龄53~74岁;冠状动脉造影术后5例,支架置入术后3例;所有患者均选择在超声指导下压迫2h,24h后复查超声。结果:6例患者一次性压迫2h后FAP闭合,2例患者一次性压迫2h后超声显示瘤腔变小,动脉与瘤腔有血流相通,再次压迫2h后闭合,无相关并发症发生,随访无复发。结论:UGCR治疗FAP是一种简单经济、安全有效的无创方法。     

Percutaneous thrombin injection for treatment of iatrogenic femoral artery pseudoaneurysms: a case for caution

The case of a patient who developed a femoral artery pseudoaneurysm following cardiac catheterization is described. After 2 failed attempts of ultrasound-guided compression repair, the patient underwent percutaneous thrombin injection with, beside of complete closure of the pseudoaneurysm, a severe limb ischemia due to distal thrombin migration with consecutive clot formation finally resulting in thigh amputation of the affected leg. Indications, advantages, and disadvantages of various options for the treatment of iatrogenic femoral artery pseudoaneurysms (vascular surgery, ultrasound-guided compression, percutaneous thrombin injection, and other nonsurgical treatment modalities), as well as risk factors for distal migration of liquid thrombin after percutaneous injection, are discussed in this report.     

超声引导下注射凝血酶对医源性股动脉假性动脉瘤的治疗

目的探讨超声引导下注射凝血酶治疗医源性股动脉假性动脉瘤(PA)的应用价值。方法使用22G细针穿刺,对8例医源性股动脉PA患者进行超声引导下瘤内注射凝血酶治疗,用二维超声及彩色多普勒观察瘤体内血栓形成情况,每次注入凝血酶100IU,凝血酶总用量不超过500IU,直至血栓形成。结果8例患者均经一次性治疗成功,凝血酶用量100~500IU,血栓形成时间0.5~1.5min,无一例出现血管内血栓形成、感染、过敏等并发症。结论超声引导凝血酶注射治疗股动脉PA安全有效,可作为经股动脉途径介入诊疗术所致医源性PA的首选治疗。     

Percutaneous occlusion of femoral artery pseudoaneurysm by para-aneurysmal saline injection.

The increasing number of coronary interventions and more aggressive anticoagulation is associated with a larger number of iatrogenic femoral pseudoaneurysms (PAs). The majority of PAs clot spontaneously or can be repaired by ultrasound-guided compression or ultrasound-guided thrombin injection. The therapeutic armamentarium for the remaining PAs ranges from different interventional procedures to surgical occlusion. In a small case series, we describe our initial experiences with a new, less invasive approach after unsuccessful compression therapy. Ultrasound-guided injection of 52 +/- 33 ml saline beneath the communication tract of the PA yields to rapid occlusion in six consecutive patients. During 4 weeks of follow-up, the PAs remained occluded in all patients and surgical intervention could be avoided.     

Ultrasound guided percutaneous thrombin injection of iatrogenic femoral artery pseudoaneurysms after coronary angiography and intervention

Ultrasound guided percutaneous thrombin injection has recently been described for the treatment of iatrogenic femoral pseudoaneurysms. Patient selection and technical aspects of this technique are still evolving and safety data, particularly after coronary intervention, remains limited. The percutaneous thrombin injection of femoral artery pseudoaneurysms in 13 consecutive patients, most of whom were receiving antiplatelet/anticoagulant treatment (aspirin 11, heparin 4, clopidogrel 6), is reported. Thrombin (1000 U/ml) was injected over several seconds until Doppler colour flow within the cavity ceased. The median dose of thrombin injected was 800 U (range 200-1000 U) and the treatment was successful in all cases without complication. In one case, thrombus was visualised within the arterial lumen immediately after thrombin injection, but this dissolved spontaneously within five minutes without evidence of embolisation. In contrast to ultrasound guided compression, percutaneous thrombin injection of femoral pseudoaneurysms is a rapid, well tolerated, and successful technique even in patients receiving antiplatelet/anticoagulant treatment.


Keywords: ultrasound guided percutaneous thrombin injection; iatrogenic femoral artery pseudoaneurysm     

Application of the percutaneuos thrombin injection in treatment of iatrogenic femoral pseudoaneurysms

Pseudoaneurysms are not a common complication of the endovascular procedures but can present a serious therapeutic problem. Both, the application of compression therapy and surgical operation can lead to the development of subsequent complications. The aim of this study was analysis of the treatment results of iatrogenic pseudoaneurysms managed with percutaneous thrombin injection. Treated group consisted of 69 patients diagnosed with iatrogenic femoral pseudoaneurysms. The indication for injection technique was ineffective compression therapy as well as necrotic changes or bacterial skin infection in the groin area or a large diameter of pseudoanurysm's chambers. Thrombin was injected percutaneously during 1-3 sessions in the dose of 100-1200 U into the centre of the chamber under ultrasound control. Primary and secondary success rate was 88% and 94% respectively. The following factors significantly decreased effectiveness of the method: complex pseudoaneurysms (with treatment efficacy 82% and 88% respectively vs 90% and 96% for simple pseudoaneurysms), and large chamber volume. Early and late recanalization of the thrombotic changes appeared in 7% and 3% of treated cases. The most frequent complication was appearance of non-elastic tumor (71%) or pain (64%) in the groin area. The most serious complication was acute lower limb ischemia detected in one case (2%) as a result of femoral artery compression by the thrombosed pseudoaneurysm. Percutaneous thrombin injection should be a preferred method of pseudoaneurysms treatment, especially in cases of ineffective compression therapy or its contraindications due to low cost of the therapy, simplicity of the technique and relatively low percentage of the complications.     

Treatment options for post-catheterisation femoral pseudoaneurysm closure

BACKGROUND: Femoral artery pseudoaneurysm (FAP) complicates from 1% to 9% of all coronary angiography procedures and contributes to extended hospitalisation as well as patient discomfort. AIM: To compare three main methods of FAP closure which are used nowadays. METHODS: Seventy-five subjects (38 females, 37 males, mean age 60.8+/-10.4 years) with post-catheterisation FAP were studied. The results of three methods of FAP closure--surgical, local compression and thrombin injection--were compared. RESULTS: Between September 2000 and July 2001, fourteen patients developed FAP; in 9 (64%) patients FAP was closed with repeated prolonged compression whereas the remaining 5 (36%) patients required surgical closure of compression-resistant FAP. We observed that FAPs with longer neck (>10 mm) and primary signs of partial spontaneous coagulation were more prone to self-closure as compared to FAPs with short neck and no signs of perimural coagulation (p=0.01). Since July 2001, we introduced ultrasound-guided thrombin injection into FAP sack. The protocol included attempt of closing FAP with probe compression and compression dressing put overnight, and, if unsuccessful, followed by a quick injection of 2 ml of thrombin solution (400-3200 U), guided by ultrasound. During this period, we identified 61 patients with FAP. Out of this group, 5 (8.2%) subjects were referred for surgery without any attempt of thrombin-injection, in 16 (26.2%) patients FAP was closed with probe compression and dressing put overnight, and in the remaining 40 (65.6%) subjects ultrasound-guided thrombin-injection was performed. Thrombin injection into FAP sack caused closure of its cavity and neck in all patients, however, five patients required additional thrombin injection during the same session, and 2 (5.0%) patients--during the next procedure. No peri-procedural complications were observed. The duration of hospital stay shortened from a mean of 26.6+/-14.5 days in surgically treated patients to 7.9+/-6.7 in those in whom FAPs were closed with compression, and to 4.6+/-2.6 days in those treated with thrombin (p<0.001). During a mean follow-up of 11+/-8.1 months, we re-examined 32 (80.0%) patients in whom FAP was closed with thrombin injection. No long-term thrombotic or embolic complications were observed. However, in 2 (6.3%) patients FAP cavity did not undergo complete resorption after 6 and 12 months of follow-up. CONCLUSIONS: Thrombin-induced closure of femoral pseudoaneurysm is a quick, safe and effective method, shortening hospitalisation time. In our Department this procedure replaced the prolonged and painful compression method.     

超声引导下凝血酶注射治疗股动脉假性动脉瘤36例

目的探讨超声引导下凝血酶注射（UGTD治疗医源性股动脉假性动脉瘤（PSA）的安全性和可行性。方法2000年1月至2007年2月，对36例经皮股动脉路径行冠状动脉介入诊疗术后发生的股动脉PSA进行了UGTI，其中男21例，女15例，年龄34482（63．5±10．8）岁。造影术后发生11例，支架置入术后发生25例。凝血酶注射成功后平卧4～6h，所有病例均在治疗后1～3d复查超声，30d临床随访。结果36例患者，单囊腔PSA32个，复合囊腔PSA4个（≥2个腔），瘤腔平均为（2．98±1．30）cm×（1．84±0．75）cm，凝血酶注射剂量为250～1000（644．29±239．10）U，34例患者1次UGTI即刻闭合瘤腔，2例注射凝血酶500U后动脉与瘤腔通道血流明显减弱，在超声引导压迫下5min闭合。UGTI治疗PSA成功率为94．4％0（34／36）。1例注射凝血酶1000U后虽然瘤腔闭合，但股浅动脉内血栓形成，行外科手术治疗。1例注射凝血酶500U后瘤腔闭合，但2min后出现寒颤、高热过敏反应，对症处理后好转。术后1d复发2例，1例超声引导压迫后瘤腔闭合，另1例再次注射凝血酶1000U成功闭合，30d临床随访无复发，UGTI治疗PSA复发率为5．6％（2／36）。结论UGTI治疗股动脉PSA是一简单、安全、快速、耐受好的方法，可作为临床治疗PSA的首选方法。     

Iatrogenic femoral artery pseudoaneurysm

Opinion statement A small (< 6 cm³ in volume or 1.8 cm in diameter), uncomplicated iatrogenic femoral artery pseudoaneurysm in a reliable patient not requiring anticoagulation can be safely observed with weekly physical examinations and ultrasound evaluations until full thrombosis is documented. The patient should be informed that any symptoms or complications should be reported to a physician immediately. A pseudoaneurysm associated with limb ischemia, severe infection, neurologic deficit, skin necrosis, rapid expansion, or hemorrhage should be treated surgically. Also, surgery is recommended if less invasive treatment strategies have failed, or if a planned surgical procedure involving the groin is anticipated. Given its high success rate, low complication rate, and cost-effectiveness, ultrasound-guided thrombin injection should be considered as first-line treatment for uncomplicated iatrogenic femoral pseudoaneurysm. Ultrasound-guided compression repair is an effective alternative to thrombin injection, especially in institutions that have little or no experience with thrombin injection. Alternative treatment strategies, such as percutaneous endovascular stenting and perfusion ballooning, are generally not recommended as first-line treatment options, because they have not been studied as extensively as ultrasound-guided compression repair or thrombin injection. If no other options are available, however, these alternative approaches may be appropriate in certain clinical situations.     

Autologous thrombin for treatment of pseudoaneurysms

Femoral pseudoaneurysms arise in up to 2% of patients after femoral cannulation for cardiac catheterisation. We used autologous thrombin for percutaneous obliteration of pseudoaneurysms occurring after catheterisation. We prepared autologous thrombin isolates from blood of ten patients with femoral pseudoaneurysms, and injected this solution into the pseudoaneurysms with duplex imaging guidance. We then assayed thrombin activity. All pseudoaneurysms were successfully thrombosed without substantial complications, although three patients needed a repeat procedure within 24 h. We have shown that autologous thrombin-induced thrombosis of pseudoaneurysms is reliable, simple, safe, and cheaper than commercial bovine or human thrombin, and avoids risks of anaphylaxis and contamination with prions.     

超声引导下凝血酶栓塞法治疗股动脉假性动脉瘤的疗效分析

目的探讨瘤腔内注射凝血酶治疗股动脉假性动脉瘤的疗效和安全性。方法78例股动脉假性动脉瘤的患者分别首选床边指压法（50例）和凝血酶注射法（28例）治疗。所有患者均使用GE LOGIQ9彩色多普勒超声仪确诊,凝血酶注射法组在超声引导下进行瘤腔内注射凝血酶栓塞治疗。结果指压法组50例患者中41例通过持续手指压迫治疗有效消除血管杂音和动脉瘤搏动,6例出现迷走神经反射,4例因不耐受再次压迫改用彩色多普勒引导下凝血酶注射法治愈,5例股动脉压迫治疗无效后改用凝血酶注射法治疗。凝血酶注射法组28例首选超声引导下瘤腔内注射凝血酶栓塞治疗的患者全部治愈,其中25例一次栓塞成功,2例经两次栓塞成功,1例出现血管迷走性晕厥;12例患者注射凝血酶后有体温轻度升高,自行好转;无动脉栓塞及静脉血栓形成、无凝血酶过敏表现、感染、出血等并发症。结论与指压法比较,超声引导下瘤腔内注射凝血酶的治疗方法有效性显著提高而不耐受性显著降低,是一种安全有效的方法。     

Pseudoaneurysms

Vascular complications that are the result of invasive diagnostic or therapeutic procedures requiring arterial access occur frequently. A common complication, pseudoaneurysm, has significant risk of expansion, extrinsic compression on native arteries, rupture, embolization, and infection. A pseudoaneurysm represents a persistent defect in the walls of the artery, resulting in extravasation of blood outside of the artery. This extravascular blood is confined to the surrounding soft tissues. Clinical suspicion and duplex ultrasonography are the primary diagnostic modalities. There are several options for treatment of pseudoaneurysms, including surgical repair and ultrasound-guided compression. However, a new therapeutic option, ultrasound-guided thrombin injection, has become the treatment of choice for pseudoaneurysms. This procedure is highly effective, rapid, and very safe. Using direct, real-time visualization of the pseudoaneurysm, a needle is inserted percutaneously into the pseudoaneurysm sac, and a small amount of dilute bovine thrombin is injected. Thrombosis of the sac is rapidly evident. Rare complications include thromboembolism into the native artery and hypersensitivity reaction to bovine thrombin.     

Sonographically guided thrombin injection for the treatment of femoral artery pseudoaneurysm

The formation of pseudoaneurysm in the femoral artery after cardiac catheterization is a well-recognized complication occurring in 1%-4% of cases. It is traditionally managed surgically and has a high morbidity. Prolonged ultrasound-guided compression of the neck of the pseudoaneurysm, and ultrasound-guided injection of thrombin into the aneurysm are newer modalities of treatment especially for small aneurysms. We describe the case of a giant pseudoaneurysm of the right femoral artery, post-arteriography, which was successfully managed with ultrasonographically guided percutaneous thrombin injection.     

Use of FemoStop system for arterial puncture site closure after coronary angioplasty

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.