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.     

A randomized comparison of a percutaneous suture device versus manual compression for femoral artery hemostasis after PTCA

BACKGROUND: The prolonged bed rest following femoral sheath removal after PTCA is a source of discomfort for the patient. We designed a randomized study to evaluate the efficacy and safety of an arterial suture device developed to percutaneously close the vascular access site after PTCA, allowing immediate sheath removal and early ambulation, compared to manual compression. METHODS: After successful PTCA, patients were randomized to manual compression or immediate femoral percutaneous closure. Exclusion criteria were arteritis, age > 80 years and > 3 previous femoral punctures on the same side. The two-needle device was used for the 6F sheath removal and the four-needle device for the 8F sheath. Ambulation was allowed 4 hours after the arterial suture. RESULTS: One hundred and sixty-seven patients (59 +/- 10 years, 81% males) were randomized to suture device (n = 91) or to manual compression (n = 76). The two groups were similar in terms of age, sex, size of sheath, number of patients with stent implantation (62 vs 61%), procedural anticoagulation. Procedural duration was 8 +/- 6 minutes with percutaneous suture versus 25 +/- 11 minutes with manual compression (P < 0.0001). Procedural success with percutaneous suture was 93% whereas six technical failures were treated with prolonged manual compression. Nonsurgical hematoma occurred in five patients (5%) with the suture device and in two (3%) with manual compression with no need for blood transfusion (P = NS). Uneventful blood oozing occurred in 11 patients (12%) with percutaneous suture and in only 2 (3%) with manual compression (P < 0.06). The tolerance of the hemostasis procedure and the length of post-procedure hospital stay (40 +/- 32 hours) were similar in the two groups. CONCLUSION: Percutaneous suture of the femoral artery, allows immediate closure of femoral puncture sites after PTCA, without increasing the incidence of vascular complications. The use of this device should allow earlier discharge and subsequent cost savings.     

A new femoral compression device compared with manual compression for bleeding control after coronary diagnostic catheterizations

ObjectiveThis study was performed to evaluate the safety and efficacy of a locally designed assiut femoral compression device (AFCD) versus manual compression (MC).BackgroundFemoral compression devices have been developed thorough the past decades without being strongly implemented in the catheterization laboratory. Their limited adoption reflects concerns of high cost and conflicting data regarding their safety.Patients and methodsThis was a prospective study. We enrolled 206 consecutive patients undergoing diagnostic coronary angiography From July, 2012 to April, 2013. They were divided into two groups: 100 patients used AFCD and 106 patients used MC for arterial hemostasis.ResultsBoth groups were comparable regarding baseline characteristics. Concerning the primary effectiveness end point, there was no difference in the mean time-to-hemostasis with AFCD (12.5 ± 3 min) vs. MC (13 ± 2 min, p = 0.4). As regards safety, none of our research population experienced major adverse events. No complication was new or unanticipated, and the type of complication did not differ between the two groups. The incidence of vagal episodes were comparable between both groups (3 patients (3%) in AFCD vs. 2 patients in MC (1.8%); p = 0.2). The use of AFCD was associated with similar occurrence of minor complications, mainly ecchymosis and oozing, compared with MC (27% vs. 27.4%, p = 0.8). Large hematoma >5 cm was noted only in 1 patients (1%) in the AFCD arm vs. 2 patients (1.8%) in the MC arm (p = 0.8).ConclusionOur results indicate that AFCD is a simple, safe and effective alternative to MC for hemostasis following diagnostic coronary angiography.     

Improved anticoagulation management after palmaz schatz coronary stent implantation by sealing the arterial puncture site with a vascular hemostasis device

Sealing the arterial puncture site with a vascular hemostasis device has the potential to maintain optimal anticoagulation after stent implantation. The level of heparinization during the first 3 days after successful stent implantation was retrospectively compared between 2 groups of medically treated patients with (group A; n = 18) and without (group B; n = 17) a Vasoseal? after sheath removal. The number of APTTs sampled in group A and B was 233 and 168, respectively. Respective mean values of APTT (seconds) in group A and B were 180 ± 79 and 172 ± 91 at day 1 (p = NS), 132 ± 43 and 125 ± 61 at day 2 (p = NS) and 123 ± 36 and 116 ± 48 at day 3 (p = NS). More APTTs were suboptimal (< 80 secs) in group B (34/168; 20%) compared to group A (17/233; 7%) [p < 0.001]. More patients in group B compared to group A had 1 or more (14/17; 82% vs. 8/18; 44%; p = 0.04), 2 or more (10/17; 59% versus 3/18; 17%; p = 0.02) and 3 or more (8/17; 47% vs. 2/18; 11%; p = 0.03) suboptimal APTTs. Bleeding complications were seen in 4 patients without and in 3 patients with a Vasoseal?. Thus application of a vascular hemostasis device results in a less variable anticoagulation after coronary stenting, but it does not abolish entry site-related bleeding complications.© 1993 Wlley-Liss, Inc     

Initial experience with a new femoral artery closure device following percutaneous coronary intervention with glycoprotein IIb/IIIa inhibition.

The aim of the study was to determine the safety and efficacy of a novel femoral artery closure device (StarClose, Abbott Vascular Devices, Redwood City, CA) following percutaneous coronary intervention employing aspirin, heparin, and glycoprotein (GP) IIb/IIIa inhibition. A prospective nonrandomized single-center pilot study of the StarClose device included a subset of patients undergoing percutaneous coronary intervention utilizing GP IIb/IIIa inhibitors. Those that fulfilled the inclusion criteria (age < 80, no periprocedural haematoma, puncture above the superficial femoral and profunda femoralis artery bifurcation, no significant femoral artery disease) underwent closure of the femoral artery puncture site with a StarClose device immediately on completion of the procedure. Time to hemostasis (TTH), bleeding, mobilization, and short-term clinical follow-up data were collected, and an ultrasound scan of the femoral artery was performed 2 weeks later. Twenty-five patients were recruited, of whom 23 underwent percutaneous coronary intervention (PCI). Their mean age was 58 +/- 12 years, 84% were male, and 63% had unstable angina. All were on aspirin 100-150 mg daily and all PCI patients received i.v. heparin 4-10,000 units at commencement of the procedure and clopidogrel 600 mg on completion. Two patients were on a tirofiban infusion and 23 received a double bolus of eptifibatide, each 0.18 mg/kg, separated by 10 min. The procedural success was 100% and device success 23/25 (92%), with 1 failure due to technical error. The median device delivery time was 36 sec (range, 11-178) and median TTH 37 sec (range, 10-509 sec). There were no major adverse events. In 10 patients, a moderate amount of tract ooze required a short period of adjunctive manual compression. Follow-up ultrasound femoral artery scans revealed no compromise of the vessel lumen. Femoral artery closure with the device following coronary angiography and intervention using glycoprotein IIb/IIIa receptor inhibitors is safe and effective. A randomized trial of a larger number of patients is warranted.     

Rotational atherectomy with a new device: Initial clinical experience

The Bard Atherectomy Catheter is a new rotational atherectomy device that consists of a flexible, hollow, thin-walled cutting catheter that, while rotated at 1,500 revolutions per minute, is advanced across the lesion over a special spiral guidewire system. We report the initial clinical experience with this device in 20 peripheral lesions in ten patients. The majority of patients were treated for limb salvage. All lesions were successfully intervened on by atherectomy followed by adjunctive balloon angioplasty. A reduction to less than 50% stenosis was achieved in 13 of the 20 lesions (65%) after atherectomy but in all 20 lesions (100%) after adjunctive angioplasty for all lesions and stenting for dissections in two. Baseline minimal lesion lumen diameter was 0.8 ± 0.7 mm with a reference vessel diameter of 4.2 ± 1.7 mm (75 ± 21% stenosis). The lumen improved to 2.0 ± 0.8 mm (45 ± 19% stenosis) (P < 0.001) following atherectomy and to 3.9 ± 1.9 mm (13 ± 16% stenosis) (P < 0.001) after adjunctive angioplasty. The average weight of removed atheroma was 45 ± 58 mg. All ten patients had initial improvement in symptoms. At 6 months follow-up there was persistent improvement in eight patients and two subjects had undergone amputations. Our early clinical experience with this low profile, flexible atherectomy device, that enables extraction of a large amount of atheroma, suggests that it will become a valuable addition to current atherectomy technologies in small- and medium-sized vessels. The value of this device in coronary vessels is under investigation. © 1996 Wiley-Liss, Inc.     

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.     

无肝素冠脉造影术后股动脉止血方法的探讨

目的：评价无肝素股动脉冠状动脉造影术（CAG）后股动脉穿刺部位应用改良加压包扎法止血的效果和安全性。方法：经股动脉途径行CAG的120例患者,分为两组,A组术后采用Angio—seal．装置止血,B组采用改良加压包扎法止血,两组抗血小板治疗相同。比较两组止血时间、止血成功率、开始活动时间、并发症和患者的舒适度。结果：①两组止血的成功率（均为100％）,制动时间[A组为（3．6±0．7）h,B组（3．8±0．5）h]．舒适度均无显著差异（P〉0．05）;②止血时间[A组（2．1±0．8）min．B组（7．5±2．8）min],加压包扎时间[A组0h,B组为（10．2±2．3）h],A组显著短于B组（P〈0．05）;③主要并发症：血肿发生率A组（11．7％）显著多于13组（3．3％）．P〈0．05。结论：无肝素股动脉冠状动脉造影术后股动脉穿刺部位应用改良加压包扎法止血效果好．价格低廉。并发症少,值得临床推广。     

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.     

Arterial puncture closure using a clip device after transpopliteal retrograde approach for recanalization of the superficial femoral artery.

Purpose: To report the safety and efficacy of a clip device to close retrograde popliteal artery puncture sites used in recanalization of the superficial femoral artery (SFA). Methods: From January 2005 to March 2007, 28 patients (20 men; mean age 66+/-10 years) with stable chronic peripheral artery disease were treated for chronic total SFA occlusion. All patients received aspirin and clopidogrel and were heparinized during the procedure. After failed antegrade recanalization, the SFA was revascularized via a retrograde transpopliteal access. The StarClose Vascular System was used to seal the popliteal artery puncture site. Results: All (100%) interventions were finished successfully, and hemostasis was secured with the StarClose device in all cases. There was 1 (3.6%) major complication with the StarClose system: a transient popliteal artery occlusion induced by plaque shift during sheath removal, which was corrected with balloon angioplasty via the femoral access. Three (10.8%) small hematomas (<5 cm) occurred at the puncture site without causing significant patient discomfort. Conclusion: In this small experience, the StarClose Vascular Closure System appeared to be an effective and safe sealing device after percutaneous transpopliteal interventions. Plaque shifting leading to stenosis or occlusion at the puncture site can occur.     

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.     

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.     

Same-day discharge after coronary stenting: a feasibility study using a hemostatic femoral puncture closure device

A major limiting factor for percutaneous coronary interventions carried out via the femoral route is the time it takes to achieve femoral artery hemostasis and subsequent mobilization. Discharge from hospital usually occurs the following day. In this pilot study, we assessed the feasibility of mobilization at 4 hours and same-day discharge from hospital of selected elective patients undergoing intracoronary stenting using the Angio-Seal Vascular Closure device. Seventy-five patients (56 +/- 10 years) with stable single-vessel coronary disease scheduled for elective coronary stenting were enrolled. All patients were mobilized at 4 hours and assessed at 10 hours postprocedure as to their suitability for hospital discharge. The first 50 patients remained in hospital overnight. The next 25 patients followed the same procedures but were discharged at 10 hours. The subjects were followed up at 48 hours and 30 days. Hemostasis was achieved in all patients following sheath removal and deployment of the Angio-Seal device. Twenty patients (27%) had minor groin oozing and two developed small hematoma. There were no major bleeding complications, pseudoaneurysm, vascular surgery, or groin infection. Groin oozing resulted in the delay of ambulation for 13 subjects but discharge was not delayed in any patient. All patients were reported to be suitable for hospital discharge at 10 hours postprocedure. There were no further complications at 30 days. The present study demonstrated that early mobilization and same-day discharge after coronary stenting using the Angio-Seal device is feasible in selected patients. Further studies are needed to determine the patient selection criteria and the potential cost-saving implications of this strategy.     

老年冠状动脉介入治疗患者三种动脉止血方法术后舒适度的比较

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。     

Closure of the subclavian artery puncture site with a percutaneous suture device after removal of an arterial pacemaker lead.

We describe the closure of a subclavian artery puncture site with a percutaneous suture device after removal of a pacemaker lead 1 week after its inadvertent positioning in the left ventricle via the subclavian artery. The lead was retracted from the left ventricle into the aorta and linked to a guiding catheter introduced via femoral artery access. The lead and the guiding catheter were removed from the artery to the subclavian area. This manoeuvre allowed the placement of a percutaneous arterial suture device (Perclose) to close the puncture site.     

Acute limb ischemia after femoral arterial closure with a vascular sealing device: successful endovascular treatment

We report on successful catheter therapy of acute occlusions of popliteal and crural arteries due to distal embolization from a vascular sealing device. A 45 years-old male patient underwent percutaneous coronary angiography. After primary successful closure of the right femoral artery by a sealing device the patient developed acute ipsilateral lower limb ischemia, most probably due to embolization of a collagen/thrombin plug. Occlusions of the popliteal and crural vessels were successfully treated by percutaneous thrombectomy, thrombolysis and ballon angioplasty. Combined percutaneous catheter therapy is a therapeutic option for occlusions of popliteal and crural vessels due to embolization from a vascular sealing device.     

Immediate sealing of arterial puncture sites after cardiac catheterization and coronary interventions: Initial U.S. feasibility trial using the Duett vascular closure device

The aim of this first U.S. feasibility study was to investigate the safety and efficacy of a novel vascular sealing device, Duett, following percutaneous endovascular procedures. Immediately following a catheterization procedure, the sealing device was deployed at the femoral arterial access site in 43 patients (diagnostic 29, intervention 11, intervention + abciximab 3). Patients were followed up at 1 month with clinical assessment, ankle‐brachial index measurement, and Doppler ultrasound of the treated femoral artery puncture site. Successful hemostasis was achieved with the Duett alone in 42/43 (97.7%) patients. There was one uncomplicated crossover to manual compression. The time to hemostasis was 4.0 ± 1.5, 6.9 ± 4.2, and 5.8 ± 1.2 min for diagnostic, interventional, and abciximab patients, respectively. At 1‐month follow‐up, one patient (2.3%) required ultrasound‐guided compression for treatment of a pseudoaneurysm. There were no other major complications. This novel vascular sealing device appears to achieve rapid and safe hemostasis successfully immediately following a wide range of percutaneous endovascular procedures. Cathet. Cardiovasc. Intervent. 50:96–102, 2000. © 2000 Wiley‐Liss, Inc.