Safety and efficacy of suture-mediated closure after percutaneous coronary interventions.

Percutaneous coronary interventions (PCI) performed with concomitant use of heparin and platelet inhibitors are safe procedures with reported vascular complication rates of approximately 6.1%. EPILOG investigators demonstrated that utilizing a low-dose heparin regimen with abciximab, along with early sheath removal, vascular access-related bleeding was significantly lower than that reported in EPIC. Recently, a suture-mediated closure (SMC) device has been reported to be safe, appears effective, and may improve patient comfort by allowing early ambulation. We conducted a retrospective analysis (January 1999 to March 2000) of complication frequencies among PCI patients who underwent SMC and those who had manual compression (non-SMC). Furthermore, we compared the overall rates of complications to patients who underwent PCI prior to the introduction of SMC (1995-1998). When comparing the current cohort to the historical cohort, there was a significant decrease in the number of retroperitoneal bleeds (0.3% vs. 0.9%; P = 0.003), hematomas (5% vs. 9%; P < 0.001), pseudoaneurysms (1.2% vs. 2.7%; P < 0.001), and need for vascular surgery (0.9% vs. 2.8%; P < 0.001). There was no difference in the number of arterio-venous fistulas and a slight increase in transfusion needs (12% vs. 10%; P = 0.03). Within the current cohort, there was no difference in the vascular complications between SMC and non-SMC PCI patients, although there were lower rates of pseudoaneurysms (0.5% vs. 1.8%; P = 0.02) and transfusion requirements (72/880 vs. 132/874; P < 0.001). These results suggest that the complication rates for SMC are not different and may be lower when compared to non-SMC patients after PCI. At our institution, the practice of early sheath removal and less aggressive heparin dosing has led to a decrease in vascular complication rates and a 66% reduction in vascular surgeries on post-PCI patients. Because of the limitations of retrospective analyses, further studies will be necessary to confirm these findings.     

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.     

股动脉血管闭合器的安全性评价

目的评价股动脉血管闭合器(VCDs)的围手术期及中长期安全性。方法连续入选2008年6月～2009年10月接受经股动脉冠状动脉造影和(或)血管成形术的患者1078例,根据治疗方法不同分为压迫止血组(369例)和VCDs组(709例),比较2组围手术期血管并发症发生率;另选2004年3月～2009年10月行髂动脉造影并使用VCDs、术后3个月后再次穿刺同侧股动脉并行髂动脉造影的患者92例,评价VCDs的中长期安全性。结果股动脉穿刺术围手术期血管并发症总发生率为0.7%。与压迫止血组比较,VCDs组围手术期血管并发症明显减少(1.6%vs 0.3%,P=0.039)。logistic回归分析,血管并发症与性别、血压、体重指数使用VCDs和积极抗凝、抗血小板治疗等无关。92例患者中,2次髂动脉造影间隔中位数为232 d,使用VCDs后复查髂动脉造影,狭窄发生率为3.3%,但均无下肢缺血症状。结论 VCDs的围手术期及中长期安全性较高。造影随访发现,使用VCDs后存在一定的狭窄率,但其发生率较低;且无下肢缺血症状。     

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.     

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     

Safety and efficacy of carotid stenting in the very elderly

Background : Carotid artery stenting (CAS) has emerged as an alternative to carotid endarterectomy (CEA) in patients at high risk for complications from surgery. The very elderly (≥80‐year‐old) are one subgroup of patients identified as being at increased risk for carotid surgery. However, there is concern that the very elderly are also at increased risk for complications of CAS. A stroke and death rate of 12% was reported in very elderly patients during the roll‐in phase of Carotid Revascularization Endarterectomy versus Stent Trial (CREST). We are reporting on a large clinical series of CAS with independent neurological assessment in the very elderly. Methods : Between 1994 and 2008, a consecutive series of 418 CAS patients (≥80‐year‐old) were treated at four high‐volume centers with extensive CAS experience. Independent neurologic assessment was performed after CAS procedures. Thirty‐day follow‐up information was available in 389 patients. Results : The average age was 83.2 ± 2.8 years. Most patients were male (63.2%), and the target lesion carotid stenosis was asymptomatic in two‐thirds (68.2%) of patients. The majority of patients treated with CAS had a history of coronary artery disease (74.4%), hypertension (87.8%), and dyslipidemia (71.1%). One third (30.1%) were diabetic and more than half (56.5%) were current or former smokers. Embolic protection devices (EPD) were used in 78.7% of cases with the CAS procedure being performed before EPD availability being the most common reason for not using them. The overall 30‐day incidence of stroke and death was 2.8% (11/389). The cumulative incidence of major cardiovascular events (stroke, death, or myocardial infarction) during that time period was 3.3% (13/389). Conclusions : This large series of CAS with independent neurologic assessment is convincing evidence that the very elderly (≥80 years) can safely undergo CAS with stroke and death rates comparable to younger patients. The key to obtaining these excellent results is that CAS be performed by high volume, experienced operators who exercise restraint regarding patient selection. © 2009 Wiley‐Liss, Inc.     

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。     

Erroneous placement of central venous catheter in the subclavian artery: Retrieval and successful hemostasis with a femoral closure device

Central venous catheter (CVC) placement, even if performed under duplex scan control, may be associated with incidental arterial injury leading to increased morbidity, mortality, and prolonged hospital stay. Erroneous CVC placement in the carotid or subclavian arteries has been usually treated surgically because those puncture sites may not be efficaciously compressed manually. However, surgery in this setting may be challenging because of difficulty of access for the catheters positioned in the subclavian artery and of the risk of cerebrovascular complications for carotid catheters. Recently, several cases have been published, describing the successful endovascular management of iatrogenic arterial injury using different types of vascular closure devices (VCD). However, in this setting, it remains difficult to be completely sure that the VCD has achieved complete hemostasis and that the patient does not subsequently incur in a clinically silent intrathoracic bleeding. We report the case of an erroneous CVC placement in the right subclavian artery successfully retrieved using an Angioseal? VCD. The immediate and complete hemostasis at the puncture site was confirmed at angiography. © 2010 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.     

Vascular access site complications with the use of closure devices in patients treated with platelet glycoprotein IIb/IIIa inhibitors during rescue angioplasty.

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.     

On-site immediate removal of intraortic balloon pump after high-risk percutaneous intervention with a 6 F closure suture device with the "preclosure" technique.

INTRODUCTION: Intraaortic balloon counterpulsation (IABP) may be necessary during percutaneous intervention (PCI) and sometimes it would be useful to withdraw it at the end of procedure. We describe the utility of a closure suture device to retrieve the IABP in the cardiac catheterization laboratory immediately after the intervention. METHODS: Observational study of nine consecutive high-risk PCI where an 8.5 F IABP had been retrieved at the end of the procedure with a 6 F Perclose with the "preclosure" technique. The baseline clinical characteristics as well as the in-hospital and 90-days follow-up are described. RESULTS: The patients age was 67.4 +/- 14.9 years (mean 45-85; three patients were >80; 3 females (33.3%). Left main coronary artery was the target lesion in 8 (88.8%) and 4 (44.4%) patients, performed by radial access. Abciximab was used in 7 patients (77.7%). Successful hemostasis was achieved in all the cases without manual or mechanical compression. Only one patient was transferred to the Coronary Care Unit due to advanced age, left main coronary artery stenting, and severe ventricular dysfunction. Five patients (55.5%) were discharged 24 h after the PCI, three (33.3%) 48 h, and only one remained 72 h after the procedure. There were no events in the 90-days follow-up. CONCLUSIONS: The "preclosure" technique with the 6 F Perclose is an ingenious approach to achieve successful hemostasis after IABP removal. It may permit to transfer the patients to units without critical care facilities, shorten the admission and reduce vascular complications in patients with peripheral vascular disease who may need the counterpulsation only during the percutaneous intervention.     

Suture closure of the femoral arteriotomy following invasive cardiac procedures: a detailed analysis of efficacy, complications, and the impact of early ambulation in 1,200 consecutive, unselected cases.

The purpose of this study was to assess the efficacy and safety of using a percutaneous suture device to close femoral arteriotomies following invasive cardiac procedures. All patients presenting for invasive cardiac procedures performed from the femoral artery were considered for suture closure. Patients were carefully assessed for access site complications, oozing, and the impact of suture closure on the safety of early ambulation. Clinical follow-up at 3-6 months was performed to assess for late complications. Femoral artery suture closures were performed in 1,200 consecutive cases in 1,097 patients. In 12.8% of cases, the patients ambulated within 1 hr. The success rate was 91.2% and the complication rate was 3.4%. Complications included the development of a hematoma (2.1%), the need for vascular surgery (0.6%), retroperitoneal hemorrhage (0.3%), blood transfusion (0.7%), local infection (0.5%), and pseudoaneurysm formation (0.1%). Factors found to be independently predictive of procedural failure were an age > 70 years, an ACT > 300 sec, left femoral artery access, and the performance of primary angioplasty. Follow-up at 3-6 months revealed no major hemorrhagic complications. We conclude that percutaneous suture closure effectively achieves femoral artery hemostasis in patients undergoing invasive cardiac procedures. The technique permits early ambulation and is associated with a relatively low incidence of complication.     

Percutaneous transcatheter closure of a large systemic to pulmonary venous fistulae in an adult patient after extracardiac fontan

Vascular fistulae are frequent complications in patients who have undergone a Fontan operation for palliation of single ventricle physiology. Fistulae involving the pulmonary vasculature may result in progressive hypoxemia, pulmonary hemorrhage, and clinical symptoms. These are commonly managed by percutaneous transcatheter embolization utilizing coils, and more recently, vascular plugs and septal occluders. We present a clinical case of an adult patient who underwent an extracardiac Fontan procedure in childhood for univentricular physiology and presented with symptoms of systemic desaturation 10 years after his surgery. The patient was found to have a large fistula from the inferior vena cava to the right inferior pulmonary vein. The fistula was attempted to be closed with a 12 mm Amplatzer Septal Occluder (St. Jude Medical, St. Paul, MN). Angiography showed continued flow across the fistula, which was then successfully occluded with an 18 mm Amplatzer “Cribriform” Septal Occluder (St. Jude Medical, St. Paul, MN). The patient experienced immediate improvement in his systemic saturation, and demonstrates continued resolution of his symptomatic hypoxia on follow‐up. This case illustrates an uncommon systemic to pulmonary vein fistula after Fontan, and a unique, successful embolization with two septal occluders, resulting in sustained symptomatic improvement. © 2015 Wiley Periodicals, Inc.     

Transcatheter closure of large persistent left superior vena cava causing cyanosis in two patients post-Fontan operation utilizing the Gianturco Grifka vascular occlusion device.

We report the successful transcatheter closure of a large persistent left superior vena cava draining into the pulmonary venous circulation causing cyanosis in two patients who had previously undergone the Fontan operation utilizing the Gianturco Grifka vascular occlusion device. Cathet Cardiovasc Intervent 2001;53:398-404.