Local vascular complications after use of the hemostatic puncture closure device Angio-Seal

BACKGROUND: As an alternative to manual pressure techniques new systems for achieving arterial hemostasis after cardiac catheterization were developed. Here we report about the diagnosis and therapy of femoral artery complications after use of the closure device Angio-Seal, consisting of an intraarterial anchor and extravascular collagen plug. PATIENTS AND METHODS: Angio-Seal was deployed in 350 patients undergoing cardiac catheterization. Vascular investigations after device application consisted of ankle/brachial-pressure-index measurement, duplex sonography, and angiography. RESULTS: Vascular complications occurred in 10 of 350 patients. In two patients complete occlusions of the superficial femoral artery required immediate vascular surgery. Stenoses of the superficial (five patients) and the common (three patients) femoral arteries were diagnosed in 8 cases. Of these 10 patients eight were obese, in 2 cases there was a further catheterization with Angio-Seal device application via the same femoral approach. Until now six patients underwent successful surgery: in 4 cases the whole Angio-Seal device was located intraarterially, there was 1 case of intima-dissection, and 1 case remained unclear due to a diagnostic delay of 7 months. In three patients with stenoses of the common femoral arteries without hemodynamic relevance no therapy was required. CONCLUSIONS: Occlusions or stenoses of femoral arteries after use of Angio-Seal can be diagnosed easily by duplex sonography. All hemodynamic relevant complications (n = 7 of 350 [2%]) concerned a puncture of superficial femoral arteries. In these patients vascular surgery seems to be an adequate therapy.     

The 6Fr Angio-Seal arterial closure device: results from a multimember prospective registry

Femoral closure devices help early ambulation after cardiac catheterization without incurring additional risk to the patients. This report summarizes the safety and efficacy data of the 6Fr Angio-Seal device.     

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.     

Predictors of complications and learning curve using the Angio-Seal closure device following interventional and diagnostic catheterization.

A retrospective study was conducted to determine the frequency and nature of groin complications when the Angio-Seal device was used on 252 occasions by one operator immediately following interventional (66%) and diagnostic (34%) procedures. Sixty-nine percent of the 238 successfully deployed cases received ticlopidine or clopidogrel, 16% received abciximab, and 15% received heparin postprocedure. Complications included vascular surgery for collagen plug perforation into the femoral artery (0.8%), failure to deploy (5.6%), pseudoaneurysm (0.4%), brisk, visible bleeding (9%), persistent ooze (14%), hematoma > 6 cm (0.8%), hematoma 1 cm(2) (10%). Multivariate analysis identified diagnostic cases (6 Fr sheaths) to be associated with a reduced risk of complications [odds ratio (OR) 0.1] while interventional procedures (8 Fr sheaths), postprocedure heparin, and body mass index (BMI) < 28 (OR 10.1, 3.2, and 2.8, respectively) were associated with increased risk. Gender, age, ticlopidine, clopidogrel, and abciximab were not independent predictors of complications. A learning curve for device deployment was observed in the first 50 cases (14% nondeployment vs. 3.5% for the subsequent 202 procedures, P = 0.009) and failure to deploy was independent of sheath size used. Angio-Seal can be used with reasonable safety and efficacy immediately after diagnostic and interventional procedures. Cathet. Cardiovasc. Intervent. 48:162-166, 1999.     

Infectious complications related to the use of the angio-seal hemostatic puncture closure device.

One hundred and eight coronary angiography procedures in which the Angio-Seal device was utilized were complicated by eight (7.4%) hematomas, of which two (1.9%) subsequently developed infection (Staphylococcus aureus endarteritis and S. aureus septic hematoma). The Angio-Seal device may be a risk factor for infection for two reasons: excessive hematoma formation (a known risk factor for endarteritis), and foreign material remaining within the arterial lumen and wall, thereby creating a nidus for infection.     

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.     

Early mobilization after diagnostic cardiac catheterization with the use of a hemostatic bandage containing thrombin

The aim of the present study was to assess the efficacy and safety of a thrombin-containing bandage for local hemostasis after femoral sheath removal in patients undergoing diagnostic cardiac catheterization. Forty-one patients undergoing diagnostic coronary angiography using a 6-F femoral sheath were included. The sheath was removed immediately after the procedure using the bandage according to a prespecified protocol. Mean compression time was 7.3+/-1.7 min and mean time from sheath removal to mobilization was 132+/-34 min. None of the patients suffered recurrent bleeding or any in-hospital and 7-day vascular complications. We conclude that in patients undergoing femoral-access diagnostic cardiac catheterization, the use of a hemostatic bandage containing thrombin was associated with short time to hemostasis with the ability for early patient mobilization without vascular complications.     

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.     

Interventional therapy of vascular complications caused by the hemostatic puncture closure device angio-seal.

The hemostatic puncture closure device Angio-Seal is a quick, safe, and easy-to-use system, allowing rapid sealing of the vascular access site following coronary angiography and interventional procedures. It is advantageous for patients in whom early mobilization is desired and may therefore decrease hospital costs. Despite the documented low complication rate, there are some specific problems. Reporting on five cases, we describe problems in diagnosis and possible interventional therapy of Angio-Seal-associated complications such as stenosis, occlusion, or peripheral embolism. Our experience led to the concept of precise diagnosis in any patient with leg symptoms and early interventional treatment with the aim of complete removal of the intra-arterial parts of the Angio-Seal device. Any delay in diagnosis and treatment increases the risk of additional thrombotic occlusion. Spontaneous dissolution of the Angio-Seal sponge limits interventional possibilities of complete removal. Cathet. Cardiovasc. Intervent. 49:142-147, 2000.     

Late cardiac perforation following percutaneous atrial septal defect closure using the Solysafe device

Percutaneous atrial septal defect closure has been demonstrated to be a safe and effective procedure. Many different devices have been utilized during the last decade with a low complication rate. We report a patient who presented with cardiac tamponade 6 months after ASD closure using the Solysafe device. Emergency surgery demonstrated a disarticulated device as well as a broken wire migrated into the pericardial space causing cardiac perforation and tamponade. To the best of our knowledge, this is the first report of late cardiac perforation following ASD closure using the Solysafe device.     

Risk of local adverse events following cardiac catheterization by hemostasis device use and gender

Hemostasis devices are primarily used to stop bleeding from the femoral artery catheterization site after cardiac diagnostic or interventional procedures. Studies assessing the effectiveness of hemostatic devices compared to manual compression have produced mixed results regarding the relative risk of serious adverse events, such as hemorrhage. This study assessed the relative risk of serious complications following the use of the two main types of hemostasis devices (as compared with manual compression), and assessed the relative rates of these complications by gender.     

Management of arterial puncture site after catheterization procedures: evaluating a suture-mediated closure device

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.     

新型血管封堵器在心导管术后应用120例观察

目的评价新一代血管封堵器Angio-Seal STS在冠状动脉造影及介入术后股动脉封闭中的应用价值。方法对重庆医科大学附属第一医院心内科2004-09—2005-12收治的298例病人,分为血管封堵器A组(120例)和人工压迫B组(178例),观察止血成功率、止血时间、卧床时间及血管性并发症。结果A组在止血时间、卧床时间及腰背痛不适上明显低于B组(P<0·05)。在止血成功率、腹股沟皮下血肿及血管迷走神经反射方面两组差异无显著性(P>0·05)。结论Angio-Seal STS血管封堵器对股动脉穿刺点能快速、有效地止血,缩短卧床时间,且不增加血管性并发症。Angio-Seal STS特点是自身紧闭式缝合,无须已往使用Angio-Seal后放置的弹簧。     

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.     

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。     

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.     

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.     

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.