The safety and efficacy of "pre-closure" utilizing the Closer suture-mediated vascular closure device for achievement of hemostasis in patients following coronary interventions: results of the second Perclose Accelerated Ambulation and Discharge (PARADISE II) Trial

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.     

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。     

糖尿病患者冠状动脉介入术后应用外周血管缝合器的效果

目的探讨糖尿病患者冠状动脉介入术后应用外周血管缝合器的安全性和有效性。方法2002年11月至2004年12月我科应用Perclose外周血管缝合器患者共678例,分为糖尿病组和非糖尿病组,观察2组应用缝合器的成功率,并发症发生率,比较其结果有无差异。结果678例成功597例,成功率88.1%,其中糖尿病组170例,成功149例,非糖尿病组508例,成功448例,结果显示无明显统计学差异,糖尿病组总的并发症为5例,非糖尿病组总的并发症为13例,差异无统计学意义。结论糖尿病患者冠状动脉介入术后应用外周血管缝合器可以带来与普通患者同样的益处。     

Safety and efficacy of the Perclose suture-mediated closure device after diagnostic and interventional catheterizations in a large consecutive population.

Arterial puncture sites after cardiac catheterization are a troublesome cause of complications. Closure devices have been developed to improve on patient comfort and safety. We evaluated a suture-mediated closure device, the Prostar-Plus device, in a consecutive population of over 10,001 diagnostic and interventional catheterizations. A significantly higher complication rate was noted for both major and minor complications in the diagnostic catheterization patients treated with the Prostar-Plus device compared to diagnostic catheterization patients treated with manual compression (2.6% major and 4.6% minor complication rate for the Prostar-Plus treatment group vs. 0.2% major and 1.8% minor complication rate for the manual compression treatment group). For the interventional patients, there were no statistical differences noted for both major and minor complications between patients treated with the Prostar-Plus device vs. manual compression. Subgroup analysis showed that older, thinner women were more likely to have complications related to the Prostar-Plus device.     

A cost-minimization analysis of the angio-seal vascular closure device following percutaneous coronary intervention

The Angio-Seal vascular closure device has been shown to be safe and effective in decreasing the time to hemostasis after percutaneous coronary intervention (PCI). The health economic implications of routinely using Angio-Seal after PCI have not been explored. We performed a cost-minimization analysis comparing routine Angio-Seal use after PCI with mechanical compression using a decision analytic model. The relative probabilities of 7 vascular access complications were derived from pooled analysis of published randomized trials. The incremental hospital cost of each vascular complication was estimated by a matched case-control analysis of 3,943 patients who underwent PCI at our center from January 2002 and December 2004. Appropriate sensitivity and uncertainty analyses were performed. After accounting for differences in expected rates of specific complications between the 2 strategies and the incremental costs of each vascular event, the routine use of Angio-Seal was associated with a lower cost per PCI procedure of 44 dollars. Probabilistic sensitivity analysis of all model assumptions using second-order Monte Carlo simulation confirmed the economic advantage of Angio-Seal in 74% of model replications. In conclusion, after PCI, the routine use of Angio-Seal for femoral vascular access management was associated with net cost savings compared with mechanical compression. This cost savings was in addition to the previously demonstrated advantages of Angio-Seal in terms of patient comfort and preference.     

抗凝和抗血小板治疗对血管缝合器有效性和安全性的影响

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。     

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.     

Perclose血管缝合器在老年患者冠状动脉介入治疗中的临床应用

目的评价Perclose血管缝合器在老年冠状动脉介入治疗患者中使用的安全性和可行性。方法将110例接受冠状动脉介入治疗的老年患者随机分为Perclose血管缝合器组(Perclose组)与人工按压组。观察Perclose血管缝合器的成功率与术后并发症的发生率。结果Perclose组止血成功率为96%,无并发症发生。人工按压组有2例血肿,1例假性动脉瘤发生。结论Perclose血管缝合器在老年患者介入治疗中使用有良好的可行性和安全性。     

Early mobilization after percutaneous catheterization and vascular closure with a novel device (Star-Close)

Arteriotomy closure devices used to obtain hemostasis at the end of cardiac catheterization represent a valid alternative to manual compression. We are the first to report on a series of 60 patients in whom a novel system was used, Star-Close, which obtains vessel closure by deployment of a clip at the puncture site. Subsequent early (2 hours) mobilization was obtained in 55 patients (92%). Unsuccessful device deployment occurred in 5 patients. We conclude that Star-Close is a novel arteriotomy closure device that, in selected patients, is safe and allows early deambulation after diagnostic cardiac catheterization.     

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.     

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 a percutaneous arterial suture device (Perclose) in patients undergoing percutaneous balloon aortic valvuloplasty.

Percutaneous balloon aortic valvuloplasty has been used as a therapeutic option for patients with severe aortic stenosis who are not candidates for aortic valve replacement. This procedure has been limited by both the high rate of aortic valve restenosis and high procedural morbidity related chiefly to the large femoral arteriotomies required. The purpose of this study was to assess the feasibility and vascular complication rate using the "Preclose" technique in patients undergoing balloon aortic valvuloplasty. We evaluated the immediate and 30-day results in 18 consecutive patients undergoing this procedure. Angiographically significant peripheral vascular disease was present in 39% of cases. Aortic balloon dilation produced significant decreases in the mean aortic valve pressure gradient from 55 +/- 20 mmHg to 30 +/- 22 mmHg (P < 0.001). Closure of the arteriotomy with an 8F (10F in 1 case) Perclose device led to immediate hemostasis in all patients. Perclose of the contralateral femoral arterial site with a 6F device was attempted in 50%, all of which were successful. The mean length of bed rest was 4.5 +/- 0.9 hr. No procedural was observed. No patient had a local vascular complication, and no patient required blood product transfusion after the procedure. The use of the "Preclose" technique for closure of femoral arteriotomies after balloon aortic valvuloplasty is feasible and associated with a low rate of periprocedural and short-term vascular complications.     

血管闭合器在冠状动脉造影和介入治疗术后的应用

目的：评价Angio-seal血管闭合器在冠脉造影和介入治疗术后应用的安全性和有效性。方法：经股动脉行冠脉造影和介入治疗术患者，共300例，其中92例以Angioseal血管闭合器进行止血，观察成功放置闭合器的即刻止血率、术后的并发症及卧床时间，并与208例手工压迫止血患者进行对比。结果：（1）Angio-seal血管闭合器封堵血管的成功率为96．7％，血管并发症为5．4％。（2）与手工压迫相比，使用血管闭合器可大大减少患者卧床时间（P〈0．001），而两组血管并发症发生率差异不显著。结论：Angio-seal闭合器止血是一种安全、可靠的止血方法。     

冠状动脉介入术后应用新型血管闭合器Boomerang(R)的初步研究

目的 评价冠状动脉造影或经皮冠状动脉介入治疗(PCI)后,应用新型血管闭合器Boomerang(R)的有效性及安全性.方法 入2005年2月至2007年3月在北京军区总医心血管内科进行冠状动脉造影或PCI的112例患者,随机应用血管闭合器Boomerang(R)(Boomerang(R)组,68例)和Angioseal(Angioseal组,44例)对股动脉穿刺部位进行封闭止血,观察两组止血时间、下肢制动时间,术后即刻、术后4h、出院前24h内出血发生率.结果 两组即刻闭合成功率均较高(94%vs 91%,P=0.78),两组止血时间[(1.89±1.23)min vs(2.01±1.21)min,P=0.633]、下肢制动时问[(5.76±2.23)h vs(5.01±2.05)h,P=0.54]、术后即刻(16%vs 15%,P=0.86)和出院前24h内(1%vs 3%,P=0.75)的小出血发生率等均无显著性差异,但术后4h Boomerang(R)组小出血发生率明显低于Angi-oseal组(7%vs 13%,P=0.04),两组均无大出血发生.与合并高血压、高脂血症的患者比较,有糖尿病和吸烟史的患者术后即刻、术后4h和出院前24h内小出血发生率均显著增加(P<0.05).结论 新型血管闭合器Boomerang(R)闭合股动脉穿刺口有效、安全,但对于有糖尿病和吸烟史的患者应谨慎选择.     

Cost effectiveness of paclitaxel-eluting stents for patients undergoing percutaneous coronary revascularization: results from the TAXUS-IV Trial.

OBJECTIVES: This study sought to compare aggregate medical care costs for patients undergoing percutaneous coronary intervention with paclitaxel-eluting stents (PES) and bare-metal stents (BMS) and to formally evaluate the incremental cost effectiveness of PES for patients undergoing single-vessel percutaneous coronary intervention. BACKGROUND: Although the cost effectiveness of SES has been studied in both clinical trials and decision-analytic models, few data exist on the cost effectiveness of alternative drug-eluting stent (DES) designs. In addition, no clinical trials have specifically examined the cost effectiveness of DES among patients managed without mandatory angiographic follow-up. METHODS: We performed a prospective economic evaluation among 1,314 patients undergoing percutaneous coronary revascularization randomized to either PES (N = 662) or BMS (N = 652) in the TAXUS-IV trial. Clinical outcomes, resource use, and costs (from a societal perspective) were assessed prospectively for all patients over a 1-year follow-up period. Cost effectiveness was defined as the incremental cost per target vessel revascularization (TVR) event avoided and was analyzed separately among cohorts assigned to mandatory angiographic follow-up (n = 732) or clinical follow-up alone (n = 582). RESULTS: The PES reduced TVR by 12.2 events per 100 patients treated, resulting in a 1-year cost difference of 572 dollars per patient with incremental cost-effectiveness ratios of 4,678 dollars per TVR avoided and 47,798 dollars/quality-adjusted life year (QALY) gained. Among patients assigned to clinical follow-up alone, the net 1-year cost difference was 97 dollars per patient with cost-effectiveness ratios of 760 dollars per TVR event avoided and $5,105/QALY gained. CONCLUSIONS: In the TAXUS-IV trial, treatment with PES led to substantial reductions in the need for repeat revascularization while increasing 1-year costs only modestly. The cost-effectiveness ratio for PES in the study population compares reasonably with that for other treatments that reduce coronary restenosis, including alternative drug-eluting stent platforms.     

Stroke during pregnancy: therapeutic options and role of percutaneous device closure

Percutaneous device closure of patent foramen ovale has developed into a therapeutic option for patients with presumed cryptogenic stroke. The appropriate use of these therapies relies on appropriate clinical assessment, as well as an understanding of the potential advantages of certain closure devices. Pregnancy is an uncommon scenario for stroke, but nonetheless represents a hypercoaguable state which may predispose to thromboembolism. We describe a case of stroke during pregnancy treated with percutaneous device closure; the role of, and alternatives to, device closure are discussed, as are specific issues related to device selection and the interventional procedure.     

Safety and effectiveness of percutaneous coronary intervention (PCI) in elderly patients. A 5-year consecutive study of 201 cases with PCI

The study objectives were to evaluate the safety and effectiveness of PCI in the elderly. The 201 cases with PCI were divided into the younger group (<60-year-old group, 33 cases), the old group (60- to 74-year-old group, 92 cases) and the very old group (75- to 89-year-old group, 76 cases). We found that the incidence of 2-vessel disease, multi-vessel disease and complex lesions in the old and very old group was more frequent than that in the younger group (p < 0.05, p < 0.05, p < 0.05). From the younger group to the very old group, the Gensini score increases significantly (40.50 vs. 42.00 vs. 45.25, p < 0.05, p < 0.01, p < 0.01). The immediate success rate of PCI was 99.01% (199/201), and no significant difference was found in the three age groups. The complete revascularization in the very old group was much less than that in the old and younger groups. Logistic regression showed that only the incomplete revascularization was the independent risk factor of adverse events (odds ratio (OR) = 2.14, 95% confidence interval (95%CI) = 1.37-5.72). We conclude that in the elderly patients with favorable tolerance of PCI, PCI immediate success rate was similar to that of the young patients, suggesting that complete revascularization of the very old patients might improve the prognosis and reduce the incidence of cardiac events.