心导管术拔鞘管后应用经皮血管闭合器疗效观察

目的　比较心血管病患者心导管术拔鞘管后采用经皮血管闭合器 (Angio Seal)止血与人工压迫止血的安全性和疗效。方法　 197例心血管病患者在行心导管术后 ,分为人工压迫止血组(99例 ,其中冠状动脉造影 5 5例 ,冠状动脉介入术 4 4例 )和Angio Seal止血组 (98例 ,冠状动脉造影5 4例 ,冠状动脉介入术 4 4例 ) ,分别应用人工压迫止血和Angio Seal止血 ,观察两组止血时间、下床走动时间和血管并发症。结果　Angio Seal止血组与人工压迫止血组相比 ,止血时间与下床走动时间显著缩短。血管并发症发生率两组无显著差异。应用Angio Seal止血的成功率达 96 %。结论　心导管术后应用经皮血管闭合器缩短了止血与下床走动时间 ,并可能减少穿刺点并发症和病人不适感。     

Immediate arterial hemostasis after cardiac catheterization: Initial experience with a new puncture closure device

A novel device for obtaining arterial hemostasis after invasive procedures was tested in 30 patients undergoing diagnostic catheterization (26 patients) or coronary angioplasty (4 patients). The device is deployed through an arterial sheath and forms a positive mechanical seal both inside and outside the defect in the arterial wall. The components are all bioabsorbable. Thirteen patients received a heparin bolus during the catheterization procedure. The activated clotting time recorded in 15 patients just prior to device deployment averaged 264 sec. 29 of 32 attempted device deployments were successful (91%); and the remaining 3 devices pulled completely out as called for by design in the event of incomplete deployment. Twenty-nine patients ultimately achieved successful hemostasis using the device, with the other patient receiving manual hemostasis. Of these 29, hemostasis was immediate and complete in 19 patients. Light digital pressure was required in another 8 patients for less than 5 min. There was minor delayed bleeding requiring supplemental light pressure in several cases. A total of 11 patients required supplemental pressure in addition to the hemostasis device. The use of bolus heparin was significantly (P = 0.05, Fisher's exact test) related to the requirement for supplemental pressure. Three patients developed hematomas, one of which was present prior to device deployment. The other two patients had received bolus heparin. No patient required transfusion or surgical repair. There was no change in the ankle/brachial systolic blood pressure index after device deployment or at late (30–60 day) follow-up. Ultrasound studies revealed no significant pathology relative to the device. There was no residual evidence of the device at 2 month follow-up ultrasound study. Thus the Kensey Nash Hemostatic Puncture Closure Device can safely, reliably, and rapidly provide arterial hemostasis after cardiac catheterization procedures. Its use warrants further study in comparison to standard manual hemostasis.     

Initial experience using Prostar™: A new device for percutaneous suture-mediated closure of arterial puncture sites

A new device that enables closure of the femoral artery puncture site by percutaneous placement of two nonabsorbable sutures (Prostar™) was evaluated. Our initial experience included 32 insertion attempts at 29 femoral arterial puncture sites and one femoral venous puncture site. The device was applied at arterial puncture sites that had been used to carry out 12 balloon angioplasties (41%), seven intracoronary stent placements (24%), five intraaortic balloon pump insertions (17%), four diagnostic angiographies (14%), and one rotational ablation (3%). The venous access site closed was in a patient who had undergone balloon angioplasty and intracoronary thrombolysis. Most patients were anticoagulated with an average activated clotting time (ACT) of 306 ± 123 sec (12 patients) or an average PTT of 68 ± 28 sec (14 patients). There were four failures to achieve hemostasis using the device due to: inability to place the device because of peripheral vascular disease, entrapment of cutaneous tissue in the suture, a suture break that prevented hemostasis from being achieved, and avulsion of the sutures from the needles. Although three other suture breaks occurred, these did not prevent hemostasis from being achieved. Thus, 88% (28/32) of attempted uses were successful, and by using a second device in two of the failed attempts, 94% (30/32) of the puncture sites were successfully closed using the device. There was one late rebleed that required 1 hr of groin clamp pressure in an angioplasty patient who had received intracoronary urokinase. An ooze of blood occurred in 4 patients, but in only 2 was this more than trivial, resulting in discontinuation of heparin in one patient and a small hematoma in the other. We conclude that this device can be used safely and effectively, even in fully anticoagulated patients who have undergone complex procedures. The ultimate role of the device will require further experience and appropriate randomized studies. © 1996 Wiley-Liss, Inc.     

Femoral artery occlusion after using a suture‐mediated arterial puncture closure device

A femoral artery occlusion is a very rare complication after using a suture‐mediated arterial puncture closing device (APCD). The mechanism of the femoral artery occlusion is unclear and its standard management has not been established. This case describes a mechanism of femoral artery occlusion by a suture‐mediated APCD and suggests a method of prevention and treatment. © 2008 Wiley‐Liss, Inc.     

心导管术后经皮动脉血管封堵器的临床应用

目的比较经皮冠状动脉介入术后,股动脉穿刺口采用Angio-Seal血管封堵器与局部人工压迫止血方法的疗效与安全性。方法196例进行心导管检查的患者,随机分为股动脉穿刺口人工压迫止血组(82例,其中冠状动脉造影术36例,冠状动脉成形术46例)和血管封堵器止血组(114例,其中冠状动脉造影术52例,冠状动脉成形术62例),观察止血时间、并发症及成功率。结果Angio-Seal血管封堵器与局部人工压迫止血法比较,止血时间明显缩短,并发症减少,成功率相当。结论Angio-Seal血管封堵器在掌握好适应证的前提下,可广泛应用于经皮冠状动脉手术后股动脉穿刺口的处理。     

A new device for percutaneous suture-mediated closure of arterial puncture sites using exteriorized needles: initial experience

PURPOSE: To assess the feasibility and initial clinical results of Closer (Perclose, Redwood City, California), a new device for percutaneous suture-mediated closure of arterial puncture sites. METHODS:Vascular interventions were performed using 6 and 7 French sheaths in 22 consecutive patients. All patients underwent suture-mediated percutaneous closure with the new device. Patients were followed by physical examination the day after the procedure. RESULTS: Immediate hemostasis was achieved in 20/22 patients (91%). In 3 out of 5 antegrade closures, only one suture was captured. In two cases, this was managed by reinsertion of a second device. In another patient, hemostasis was not achieved by the device due to knot entrapment. No major complications were observed. The overall rate of minor complications was 9% (2/22) due to hematomas without the need for blood transfusions. CONCLUSION: Percutaneous suture with this new device is an acceptably safe and effective method to achieve immediate hemostasis of the arterial access site after interventional procedures with minimized manipulation of the puncture track.     

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.     

Groin complications associated with collagen plug closure of femoral arterial puncture sites in anticoagulated patients

A retrospective study was conducted to determine the frequency and nature of groin complications when the Vasoseal™ (Datascope Corp., NJ) hemostasis device was used on 204 occasions to enable removal of the groin sheath in anticoagulated patients. The patients had undergone balloon angioplasty (53%), coronary stenting (20%), and diagnostic angiography (27%). Complications included vascular surgery in 5% including 2 embolized collagen plugs, failure to achieve hemostasis (2%), late external bleeding (2%), purulent discharge (1.5%), a minor ooze of blood (7%), hematomas >6 cm (6%), and hematomas ≤6 cm (7%). One or more complications occurred with 64 of 204 (30.5%) uses. Multivariate analysis identified diagnostic angiography to be associated with a reduced risk of complications [odds ratio (OR) 0.25], while stent procedure (OR 2.7) and female gender (OR 2.5) were associated with increased risk. This complication rate is similar to other reported series except for a higher rate of vascular surgery. The high incidence of anticoagulation in our study patients (94%) may explain this difference. We recommend caution and adherence to the recommended technique when the device is used in anticoagulated patients. Cathet. Cardiovasc. Diagn. 43:124–129, 1998. © 1998 Wiley-Liss, Inc.     

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.     

血管缝合器在经股动脉冠状动脉介入治疗后的临床应用

目的:评价血管缝合器Angio-seal缝合冠状动脉介入治疗术(PCI)股动脉的效果。方法:选择我院PCI病人61 例,平均年龄(67．4±11．5)岁,随机分为应用血管缝合器组30例,手法压迫组(人工压迫、绷带加压包扎)31例。比较两 组病人的平均止血时间、卧床时间、住院时间,局部血管的并发症。结果:血管缝合器组与手法压迫组平均止血时间分 别为(5．7±3．4)min,(24．9±5．6)min;平均卧床时间分别为(4．3±1．0)h,(23．8±2．1)h(P均<0．01);平均住院 天数分别为(10±3)d．(15±4)d(P<0．05);穿刺部位并发症例数分别为1例(3．3％),7例(22．6％),P<0．01。结 论:血管缝合器缝合冠状动脉介入术后全身肝素化的血管穿刺部位,效果理想,值得推广。     

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.     

Percutaneous suture-mediated closure of femoral access sites deployed through the procedure sheath: initial clinical experience with a novel vascular closure device.

The objective of this study was to assess the initial safety and feasibility of a novel suture-mediated device for closure of femoral access sites immediately after diagnostic or interventional cardiac catheterization. In a prospective study, 150 patients (mean age, 61.5 years; 109 male) underwent femoral access closure with a novel suture closure device (Superstitch, Sutura) immediately after diagnostic (n = 106) or interventional (n = 44) catheterization procedures, independently of the coagulation status. All patients were monitored for 24 hr after the procedure. The closure device was successfully deployed in 92% of patients. Immediate hemostasis was achieved in 77% of patients with no differences between patients undergoing diagnostic catheterization or coronary interventions (79% vs. 73%; P = 0.659). After 2 min of additional light manual compression, hemostasis was achieved in 92% of patients. There was one major complication requiring vascular surgery (0.7%). The novel suture closure 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.     

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.     

Management of the arterial puncture site

With more complex interventional procedures, such as intracoronary stent placement, there is a higher incidence of procedural related peripheral vascular complications including pseudoaneurysm and hemorrhage. In these procedures, the amount of anticoagulation as well as the use of thrombolytic agents intraprocedurally increases the risk of complication. Meticulous care during vascular access, careful use and monitoring of anticoagulation, and patient selection are helpful in reducing the risk. Newer vascular hemostatic devices utilizing biodegradable collagen plugs might be of advantage since they allow early sheath removal without interrupting anticoagulation and, therefore, early ambulation. However, it remains to be determined, whether these devices are effective in reducing complications, duration of bed rest and hospitalization, or improvement of stent patency. Newer designs, e.g., coated or biodegradable stents, or different deployment strategies might reduce the need of anticoagulation and lower the risk of peripheral vascular complications.     

Safety and efficacy of repeat transradial access for cardiac catheterization procedures.

To determine the safety and efficacy of repeat transradial cardiac catheterization, 1,362 consecutive transradial procedures were examined. Repeat transradial procedures were identified (group I, n = 73) and compared with index procedures (group II, n = 1,289). Baseline patient characteristics, procedure success rates (100% vs. 97.9%; P = NS), complication rates (0% vs. 0.08%; P = NS), and procedure times (23.9 +/- 27.3 min vs. 18.2 +/- 14.7 min; P = NS) were similar between groups. This study suggests that repeat transradial catheterization procedures can be performed safely and successfully in appropriately selected patients.     

Radial artery mycotic pseudoaneurysm in a haemophiliac: a potentially fatal complication of arterial catheterization

We present a case of radial artery pseudoaneurysm formation in a haemophiliac patient, which developed after radial artery cannulation. Haematologists and anaesthetists should be aware of this potentially fatal condition.     

Use of a percutaneous vascular suture device for closure of an inadvertent subclavian artery puncture.

A well-known complication of central venous catheterization is inadvertent arterial sheath placement. Sheath removal from noncompressible arteries has the potential for severe complications. We report a case of inadvertent subclavian arterial sheath placement during an attempted internal jugular venous catheterization. This was successfully removed using a percutaneous vascular suture device.     

Initial experience with the Cardiva Boomerang vascular closure device in diagnostic catheterization.

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

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