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1.
The objective of this study was to evaluate the effectiveness of two different closure devices in patients undergoing rescue percutaneous coronary intervention (PCI) using IIb/IIIa inhibitors and to compare it with patients undergoing elective PCI. One hundred sixty-two patients undergoing rescue PCI treated with IIb/IIIa inhibitors underwent vascular access site closure (6 Fr Perclose, n = 92, or 6 Fr Angioseal, n = 70). Vascular complications were compared with a sex- and age-matched group (n = 100) of patients undergoing manual compression after sheath removal and a similar group of patients undergoing elective PCI (n = 196). The incidence of access site complications was not significantly different between the three groups undergoing rescue PCI and was not higher than in patient receiving GP IIb/IIIa inhibitors without fibrinolysis (RR = 0.95; 95% CI = 0.88-1.01). In patients undergoing rescue PCI and receiving IIb/IIIa inhibitors, closure devices allow early sheath removal and are associated with similar outcomes compared with manual compression and elective PCI regardless of the type of closure device used.  相似文献   

2.
The safety and efficacy of a suture-mediated vascular closure device (Perclose, Abbott, Redwood City, CA) for hemostasis after percutaneous vascular access using >or=8-Fr sheath in the femoral vein after cardiac catheterization in children was assessed. Efficacy was determined by time to hemostasis and vessel integrity, using Doppler vascular ultrasound within 24 hours of the procedure. Forty children were randomized to treatment with either the closure device (n = 20, 10 males, weight 34.8 +/- 21 kg) or manual compression (n = 20, 10 males, weight 33.7 +/- 16 kg, P = 0.57 between groups for weight). Sheath sizes used were >or=8 French (8 Fr, n = 8; 9 Fr, n = 7; 10 Fr, n = 1; 11 Fr, n = 1; 12 Fr, n = 2; and 14 Fr, n = 1). Successful suture deployment was achieved in 14 of the 20 children. Mean time to hemostasis was 6.2 +/- 0.9 versus 14.9 +/- 1.1 minutes in controls (P = 0.003). Five of six unsuccessful deployments were in children with weights <20 kg. There were no differences in the occurrence of vascular complications (i.e., intraluminal thrombus) between the two groups as determined by ultrasound. A suture-mediated device appears safe and effective in achieving rapid vascular hemostasis even after the use of large sheath sizes in children.  相似文献   

3.
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.  相似文献   

4.
Groin complications remain the most common complication of cardiac catheterization procedures. While the use of closure devices is increasing for arterial sheaths, venous sheaths tend to be removed and hemostasis achieved with manual compression. We report our experience using Perclose suture-mediated vascular closure device to achieve hemostasis and early mobility in patients who have had venous access as part of their procedure. There were a total of 42 patients (21 males; average age, 63.5 years) studied. The majority of the patients had 7 Fr sheaths (24), with access sites of sheaths up to 14 Fr being closed with this technique. Two patients developed complications at the access site: one patient requiring rehospitalization for intravenous antibiotics because of late access site infection, and one patient with deep venous thrombosis and pulmonary emboli. We conclude that the use of the Perclose suture-mediated closure device for closure of femoral venous access sites is feasible and should be considered especially in patients with larger venous sheaths and those at increased risk of groin complications.  相似文献   

5.
目的探讨抗凝和抗血小板治疗对血管缝合器临床应用有效性和安全性的影响。方法回顾性分析抗凝和抗血小板治疗后进行冠状动脉(冠脉)造影(CAG)和或冠心病介入治疗(PCI)并采用徒手压迫或血管缝合止血的成功率、失败率以及血管并发症等。CAG组仅接受常规的抗凝和抗血小板治疗,而PCI组接受强化的抗凝和抗血小板治疗,包括术前使用噻氯匹定或氯吡格雷,术中使用肝素。结果共完成股动脉血管缝合218例,其中CAG组120例,PCI组98例,血管缝合成功率分别高达91.7%和90.8%(组间差异无统计学意义,P>0.05),均低于徒手压迫的成功率(P<0.05),而且分别有8.3%和9.2%的失败率,但其血管并发症仅见小血肿伴股动脉感染,发生率仅为1%,甚至低于徒手压迫;而且血管缝合不受是否已用抗凝剂和抗血小板药物的制约,可以在CAG和或PCI术后即刻拔鞘,止血方法简便,而且省时省力,患者也易于接受。结论常规或强化的抗凝和抗血小板治疗后应用血管缝合器即刻止血有效而安全,其血管并发症与徒手压迫相似甚至更低。  相似文献   

6.
Percutaneous aortic valvuloplasty produces acute hemodynamic and clinical improvement in patients with aortic stenosis who are poor candidates for surgical valve replacement. The benefits of this procedure are mitigated by the high restenosis rates and 1--2 year mortality, in addition to significant vascular complications associated with the large arterial puncture necessary for retrograde arterial approaches. We describe the use of suture closure techniques to reduce the vascular morbidity associated with this procedure. We reviewed 31 consecutive patients who underwent percutaneous aortic valvuloplasty and suture closure with the Perclose device between April 1998 and September 2000. After diagnostic catheterization using 6--8 French (Fr) sheaths, an 8 or 10 Fr Perclose device was preloaded into the artery and the untied sutures left in place. A 12.5 or 14 Fr sheath was passed over the wire, through the sutures. The sutures were tied at the conclusion of the procedure, in conjunction with sheath removal. Twenty-seven out of 31 patients (87%) had successful suture closure of the arteriotomy and did not require prolonged bed rest, manual compression or a compression device. There were 4 failures of percutaneous suture closure, requiring conventional manual compression and bed rest for hemostasis. No patient required surgical repair of the arteriotomy, nor were there any limb complications. Compared to 39 consecutive prior patients who had their arterial puncture managed with manual compression, length of stay was shorter (2.2 days versus 5.3 days) and fewer patients received blood transfusions (0% versus 29%). Preloaded suture closure of the arterial puncture is a useful technique for achieving hemostasis after removal of the large sheaths used for percutaneous valvuloplasty, and reduces the post-procedure patient discomfort and prolonged bed rest associated with this procedure.  相似文献   

7.
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.  相似文献   

8.
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.  相似文献   

9.
The most consistent procedural predictor of vascular access site complications thus far has been the intensity and duration of anticoagulant therapy during and after percutaneous coronary interventions (PCI). Several devices have been developed to aid in the closure of the femoral arteriotomy. This report describes the clinical outcome of unsuccessful deployment of femoral closure devices in a cohort of 285 consecutive patients who underwent PCI and were treated with platelet glycoprotein (GP) IIb/IIIa inhibitors. Manual femoral artery compression was used in 123 patients, Perclose in 123 patients, and AngioSeal in 39 patients. Successful homeostasis was achieved in 98.4% of patients who received manual compression, in 91.9% of the Perclose-sealed arteriotomy, and in 84.6% of patients who received the AngioSeal closure device (P = 0.004). The incidence of vascular complications after successful deployment was 9%. Patients not achieving hemostasis with closure device or 1 degrees manual compression developed complications in the majority of cases (> 80%; P < 0.05). By multivariate analysis (with adjustment for baseline differences), the use of AngioSeal closure device was found to be an independent risk factors leading to primary deployment failure and all access site complications (OR 2.97; 95% CI 1.5-6.0; P = 0.006). In summary, failed hemostasis by artery closure devices in patients undergoing PCI who are treated with GP IIb/IIIa inhibitors is associated with significant vascular complications. AngioSeal may be associated with a higher failure rate, while manual compression and Perclose seem to be more effective with a lower complication rate.  相似文献   

10.
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.  相似文献   

11.
目的比较冠状动脉介入治疗(PCI)三种动脉止血方法对老年患者术后舒适度的影响,探讨适宜的护理方案。方法 396例接受冠状动脉介入治疗的老年患者,按股动脉穿刺点止血方法分为手工压迫组(A组,n=162),Femostop压迫组(B组,n=106),和Perclose组(C组,n=128),监测各组患者入院时、术前、术后6h、术后1d内心率、血压变化,睡眠困难、胃肠道症状、躯体疼痛以及出血血栓事件的发生率。结果与手工压迫组比较,Per-close组患者术后生命体征波动小,睡眠困难、排尿障碍、胃肠道症状、躯体疼痛发生程度较轻;Femostop组术后舒适度各指标与手工压迫组相比无差异;Perclose组出血并发症明显低于Femostop压迫组及手工压迫组。三组血栓事件的发生率无明显差异。结论对接受PCI治疗的老年患者,Perclose止血方法可明显改善患者术后舒适程度;对接受不同止血方法的患者应采取不同的护理方案,以改进护理效率及质量。  相似文献   

12.
Advancement of coronary interventions and portable hemodynamic device requires placement of large bore sheaths. Access for large caliber sheaths, its placement, maintenance, and hemostasis is very challenging and one of the key ailments for successful procedures. Traditional hemostasis method is manual compression, which is unattractive due to its own limitations and subsequent complications. Single closure device for sheath size larger than 8 French (Fr) is not available. We performed retrospective analysis of large cohort of patients with 13, 14 Fr sheaths (Impella device [ABIOMED]) percutaneous closure with the use of two Perclose devices. Two perclose devices were placed in a “Preclose” fashion and hemostasis was obtained few days later once hemodynamic support was weaned off by deployment of perclose sutures.
  相似文献   

13.
经皮血管缝合器的安全性和疗效观察   总被引:9,自引:0,他引:9  
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  相似文献   

14.
目的评价血管缝合器(Perclose和Angioseal)在冠状动脉造影(CAG)或经皮冠状动脉内介入术(PCI)后股动脉止血的临床应用价值。方法选择2004年12月至2005年12月在我院行CAG或PCI术的患者180例,分为A、B、C3组,每组60例。A组使用Perclose封闭股动脉穿刺点,B组使用Angioseal封闭股动脉穿刺点,C组使用常规人工压迫方法止血。观察止血时间、制动时间、及术后并发症的发生情况。结果使用Perclose和Angioseal的止血时间和下肢制动时间均较手法压迫止血显著缩短(均P<0.01),其中使用Angioseal的止血时间还要略少于使用Perclose的止血时间,且操作更简单,但二者在止血时间和制动时间方面无统计学差异。3组在术后并发症方面无统计学差异。结论Perclose和Angioseal较常规压迫止血显著缩短止血时间和患者卧床时间。  相似文献   

15.
冠脉支架术后Perclose缝合与手工压迫止血的对比研究   总被引:6,自引:0,他引:6  
目的评价老年冠状动脉(以下称冠脉)支架术后Perclose缝合止血与手工压迫止血的优缺点,为老年冠脉支架术后处理穿刺血管提供参考。方法324例老年冠脉支架术后病人,165例Perclose缝合止血(缝合组),159例手工压迫止血(手工组)。比较止血时间、下肢制动时间、血管并发症、因卧床引起的不适发生率和止血后护理时间。结果两种止血方法同样安全有效。但是,缝合成功者止血时间、下肢制动时间和止血后护理时间明显较手工止血短,血管并发症及因卧床所致不适的发生率较手工止血低。缝合失败者上述时间明显延长,血管并发症及因卧床所致的不适程度增加。结论Perclose缝合止血的优点:(1)与手工止血同样安全有效;(2)止血、下肢制动和护理时间明显缩短,因卧床引起的不适和血管并发症发生率低。缺点:(1)费用昂贵;(2)一旦缝合失败,被迫在肝素化状态下压迫止血,导致血管并发症发生率增高,加重病人的经济和心理负担。  相似文献   

16.
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  相似文献   

17.
Percutaneous suture closure for femoral artery hemostasis has gained broad use over the last few years since its introduction. The appeal of suture closure is the immediate and definitive hemostasis that it achieves, even in anticoagulated patients. Described is the use of the Perclose Techstar XL 6Fr suture closure device for the management of brachial artery puncture after diagnostic and therapeutic catheterization. A 6Fr Perclose Techstar device was used for hemostasis during ten procedures in eight patients. In addition, 6Fr and 7Fr sheaths were used. Hemostasis was achieved in all but one patient, in whom hemostasis was not achieved and surgical repair was necessary. The Perclose Techstar device is useful for selected patients for achieving brachial arterial puncture site hemostasis. The large excursion of the foot of the new closer device may not be as applicable in arteries as small as the brachial artery. Patients who are obese may be best suited for this approach.  相似文献   

18.
Objective: This prospective randomized trial compared the Angio‐Seal VIP? with Perclose Proglide? and to manual compression with respect to time to hemostasis and ambulation, patient satisfaction, and vascular complications following percutaneous coronary intervention (PCI). Background: The use of arterial closure devices for the reduction of vascular complications following PCI remains controversial. There have been no head to head trials comparing these most commonly used arterial closure devices following PCI. Methods: Two hundred patients undergoing PCI were randomized to manual compression, Perclose Proglide? or Angio‐Seal VIP?. Ambulation was allowed 3 hr after Perclose Proglide? or Angio‐Seal VIP? and 6 hr after compression. Results: There were 10 failures to deploy Perclose Proglide? and none for Angio‐Seal? (P < 0.01). Time to hemostasis was significantly shorter with Angio‐Seal VIP? compared with Perclose Proglide? (5.3 vs. 46.8 min, P < 0.01). Time to ambulation was shorter with Angio‐Seal VIP? than with Perclose Proglide? (261 vs. 334 min, P < 0.05) and the time to ambulation, as expected, was longest with compression (943 min, P < 0.01 vs. Angio‐Seal VIP? and Perclose Proglide?). Delay in ambulation was higher with Perclose Proglide? than with Angio‐Seal VIP? (18 vs. 9, P < 0.01). There was no significant difference in major vascular complications between groups. Compared with compression, patient discomfort was significantly improved with Angio‐Seal? (1.5 vs. 2.0, P < 0.01), but not with Perclose Proglide?. Conclusion: The Angio‐Seal VIP? device has a high rate of deployment success, which is significantly better than that of Perclose Proglide?. Angio‐Seal VIP? allows for earlier hemostasis and ambulation compared with both compression and Perclose Proglide? and is associated with greater patient satisfaction compared with compression. © 2008 Wiley‐Liss, Inc.  相似文献   

19.
BACKGROUND: Suture-mediated closure devices have been developed to improve patient comfort and safety following percutaneous coronary interventions (PCI). The Perclose AcceleRated Ambulation and DISchargE (PARADISE) trial which we reported previously showed that the Prostar XL appears to be a safe and effective device to achieve hemostasis, improve time-to-ambulation and discharge post-PCI. The diameter of suture capture with the Closer 6 Fr suture-mediated closure device is larger than an 8 Fr hole. This study was performed to assess the pre-closure efficacy using the Closer device in terms of time-to-hemostasis, ambulation and discharge, as well as the incidence of peripheral vascular complications. METHODS: Between January and September 2001, 153 consecutive patients were enrolled in this study. In 97 patients, the Closer sutures were introduced prior to insertion of the 8 Fr sheath (pre-closure arm). In 56 patients, the sutures were tied at the conclusion of PCI upon sheath removal (standard arm). RESULTS: The Closer device was successfully placed on 152 of 153 attempts. The time-to-hemostasis, ambulation and discharge of the pre-closure arm patients seemed to be comparable to those of the standard arm and the PARADISE trial. No major complications were reported. CONCLUSION: The Closer seems to be as safe and effective as the Prostar XL device. The pre-closure technique is a safe means of achieving hemostasis post-PCI using large-sized sheaths without major complications.  相似文献   

20.
Aortic valvuloplasty procedures have been limited principally by the occurrence of restenosis in this patient population. Once a decision has been made to proceed with aortic valvuloplasty, one of the next major concerns is management of the femoral artery puncture. For these procedures, 12Fr and 14Fr sheath introducers and prolonged compression with clamps or hemostatic devices have been necessary. Prolonged immobilization is painful for the elderly population in whom aortic valvuloplasty is used. The ability to use percutaneous suture closure to eliminate the need for manual compression, especially for clamp or hemostatic devices, has greatly improved patient tolerance for these procedures. A technique for preloading the suture closure device prior to insertion of a large bore sheath is the technique of choice to make this possible. Mitral valvuloplasty has faced fewer limitations and of course yields results equivalent to surgical commissurotomy in randomized trials. Improved management of the 14Fr femoral venous site has made outpatient treatment simpler. The technical approach necessary for success in the venous system uses contrast injections through the Perclose device marker port to insure that the device is properly positioned prior to deployment of the sutures. More rapid immobilization and simplified postprocedural management can be achieved using percutaneous suture closure for large caliber sheaths after mitral and aortic valvuloplasty.  相似文献   

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