Safety and efficacy of a 6 French perclose arterial suturing device following percutaneous coronary interventions: a pilot evaluation

BACKGROUND: Arterial access site management after percutaneous coronary intervention (PCI) is a matter of increasing importance in this era of potent antiplatelet pharmacotherapy. We evaluated the safety and efficacy of a 6 French (Fr) Perclose suturing device in achieving rapid hemostasis of the access site after PCI and thus improving patient comfort. METHODS: The 6 Fr Perclose (Prostar) device consists of a suture-based closure device delivered via introducer sheath designed for suturing of the arteriotomy puncture site. Over a 3-month period, the device was used in 48 consecutive PCI treated patients (age, 62 13 years; 70% male; 44% post myocardial infarction) and in-hospital groin complication rate was compared to 48 consecutive patients (age, 64 12 years; 64% male; 33% post myocardial infarction) who had manual compression hemostasis. RESULTS: Antiplatelet glycoprotein IIb/IIIa antagonists were used more frequently during and following the procedure in 58% of Perclose-treated patients versus 42% of the manual compression group (p = 0.019). Leg immobilization duration was 3 4 hours in all patients sutured by the device; in patients with manual compression, the sheath was removed at an average of 4.8 2.5 hours after termination of the PCI and an additional 6 hours of leg immobilization were subsequently required. No difference in overall major complication rate was found between groups (6.2% in suture-mediated patients versus 9.3% in manual compression group; p = 0.60). In 3 patients (6.2%) treated using the device, adjunctive manual compression was required in addition to groin suturing due to technical failure or residual oozing from the arteriotomy site. CONCLUSION: The 6 Fr Perclose device can be safely used to achieve rapid hemostasis and the device may hasten bed mobilization of PCI-treated patients despite frequent use of potent antiplatelet pharmacotherapy during coronary interventions.     

Clinical experience of StarClose vascular closure device in patients with first and recurrent femoral punctures

OBJECTIVE: We present our clinical experience of StarClose in patients undergoing coronary interventions, including its use in patients after repeated puncture of the same femoral access site. BACKGROUND: The StarClose is a novel vascular closure device that deploys a small, flexible, circumferential nitinol clip onto the femoral artery surface. METHODS: In this study, 103 consecutive patients (24% with repeated punctures) who underwent percutaneous coronary intervention and received a StarClose were followed up prospectively. The patients were assessed for vascular complications prior to hospital discharge. Device success, based on time-to-hemostasis, was divided into (1) immediate success: hemostasis achieved immediately after StarClose deployment without the need for adjunctive manual compression, (2) partial success: occurrence of minor oozing after StarClose deployment and hemostasis achieved after <3 minutes of manual compression, and (3) device failure: need for adjunctive manual compression for >3 minutes. RESULTS: Immediate success, partial success, and device failure rates were 74% (n = 68), 16% (n = 15), and 10% (n = 9), respectively. There were no major complications attributable to the StarClose device. There were 10 (9.7%) cases of minor complications; all were recurrent wound bleeding requiring manual compression in the wards. Among these 10 cases of recurrent bleeding, 5 (50%) had initial device success (immediate success, n = 2, partial success, n = 3) in the catheterization laboratory. The risk for recurrent bleeding was 2.9% after immediate device success and 20.0% after partial device success. CONCLUSION: Our study found no major complications but a 10% failure rate and a 9.7% rate of minor complications. Close surveillance is important as there is a risk for recurrent bleeding, especially in patients with partial device success as defined in this report.     

The StarClose Vascular Closure System: interventional results from the CLIP study.

BACKGROUND: The StarClose Vascular Closure System is a femoral access site closure technology that uses a flexible nitinol clip to complete a circumferential, extravascular arteriotomy close. The Clip CLosure In Percutaneous Procedures study was initiated to study the safety and efficacy of the StarClose device in subjects undergoing diagnostic and interventional catheterization procedures. METHODS: A total of 17 U.S. sites enrolled 596 subjects, with 483 subjects randomized at a 2:1 ratio to receive StarClose or standard compression of the arteriotomy after the percutaneous procedure. The study included roll-in (n = 113), diagnostic (n = 208), and interventional (n = 275) arms with a primary safety endpoint of major vascular complications through 30 days and a primary efficacy endpoint of postprocedure time to hemostasis. RESULTS: The results of the diagnostic StarClose cohort have been reported separately. Results for the interventional arm revealed major vascular complications occurring in 1.1% of StarClose subjects (2/184) and 1.1% in manual compression subjects (1/91; P = 1.00). No infections were seen in either cohort. Minor complications in the StarClose interventional group occurred at a rate of 4.3% (8/184) and with compression at 9.9% (9/91; P = 0.107). Pseudoaneurysm or arteriovenous fistula was not seen with StarClose. With StarClose, procedural success was 100% (136/136) for the diagnostic group and 98.9% (181/183) in the interventional group. Device success for the treatment group was 86.8%. In the interventional cohort, 87.3% (158/181) of StarClose subjects reported a pain scale of 0-3 compared with 93.3% (84/90) in the compression group, which was not statistically different. CONCLUSIONS: The clinical results of this study demonstrate that the StarClose Vascular Closure System is noninferior to manual compression with respect to the primary safety endpoint of major vascular events in subjects who undergo percutaneous interventional procedures. StarClose significantly reduced time to hemostasis, ambulation, and dischargeability when compared with compression.     

Initial experience with a new compression device for hemostasis after femoral arterial puncture.

We evaluated a new hemostasis device to maintain focused pressure over the femoral artery puncture site for 2-6 hours in 330 cases after diagnostic catheterization or coronary angioplasty. No patient developed later hematoma or vascular complications. The initial favorable experience suggests that this hemostasis device has advantageous features of stability and site visualization and is a suitable adjunct to current methods of maintaining puncture site pressure after brief manual compression following arterial catheterization.     

Interpretation of cardiac pathophysiology from pressure waveform analysis: Effects of nitroglycerin

We evaluated a new hemostasis device to maintain focused pressure over the femoral artery puncture site for 2–6 hours in 330 cases after diagnostic catheterization or coronary angio-plasty. No patient developed later hematoma or vascular complications. The initial favorable experience suggests that this hemostasis device has advantageous features of stability and site visualization and is a suitable adjunct to current methods of maintaining puncture site pressure after brief manual compression following arterial catheterization. © 1992 Wiley-Liss, Inc.     

The safety and efficacy of the StarClose Vascular Closure System: the ultrasound substudy of the CLIP study.

BACKGROUND: The StarClose Vascular Closure System (Abbott Vascular, Redwood City, CA) features a nitinol clip that is designed to achieve closure of the femoral arteriotomy access site. The CLIP Study was performed to assess the safety and efficacy of StarClose when compared with standard manual compression following 5-6 French diagnostic or interventional percutaneous procedures. A substudy of this trial was designed to assess the utility of duplex ultrasonography to assess patency of the femoral artery and to determine access site complications (pseudoaneurysm, arteriovenous fistula, hematoma, deep vein thrombosis) in a multicenter prospective trial. This is the report of the duplex ultrasound (DUS) substudy of the CLIP trial. METHODS: A total of 17 U.S. sites enrolled 596 subjects with 483 subjects randomized at a 2:1 ratio to receive StarClose or manual compression of the arteriotomy after a percutaneous procedure. The study included roll-in (n = 113), diagnostic (n = 208), and interventional (n = 275) arms with a primary safety endpoint of major vascular complications through 30 days and a primary efficacy endpoint of postprocedure time to hemostasis. A substudy of the CLIP interventional arm evaluated DUS images of the closure site at five study sites, targeting 100 subjects at day 30 following hemostasis. The DUS protocol was devised and implemented by an independent vascular ultrasound core laboratory with extensive experience in vascular device trials. DUS inguinal region from 6 cm proximal to 6 cm distal to the arteriotomy puncture was performed. A qualitative examination was performed to determine the presence of iatrogenic vascular injuries: hematoma, pseudoaneurysm (PSA), arteriovenous fistula (AVF), and arterial/venous thrombosis or stenosis using 2-dimensional gray scale, color, and focused Doppler images. RESULTS: DUS of 96 subjects randomized to StarClose (n = 71) and compression (n = 25) were performed and evaluated. There was no evidence of hematoma, PSA, or AVF observed in the StarClose group. No StarClose subjects in the substudy had a PSA or AVF. All patients in the substudy demonstrated patency of the access site artery and vein without thrombosis or stenosis. Finally, in the entire study cohort, no clinically-driven DUS studies demonstrated iatrogenic vascular injury or vessel thrombosis in the StarClose treated patients. CONCLUSION: DUS, a safe and reliable method for determining the safety and efficacy of access site closure devices, is a reliable, safe, inexpensive and accurate method of assessing vascular access site complications in multicenter trials. In this substudy of the CLIP study, DUS found no statistical difference in access site complications between the StarClose and manual compression groups. Both groups maintained vessel patency without stenosis, thrombosis, hematoma, pseudoaneurysm, or AV fistula.     

Efficacy of Percutaneous Vascular Hemostasis System Prostar: Comparison to Manual Compression

In this study, we evaluated the safety and efficacy of the percutaneous vascular surgery device (Prostar) for sealing the femoral artery puncture site after coronary interventions. We also compared the results with Prostar (n = 167) and conventional manual compression methods (n = 50) in a nonrandomized fashion. The average time to hemostasis in the Prostar system group was 13.5 minutes, versus 36.6 minutes in the compression group. The average time to ambulation was 2.2 hours in the Prostar system group, versus 17.8 hours in the manual group. Bleeding was observed in 1.2% of the subjects in the Prostar system group, versus 12% in the manual compression group. One emergency surgery was required in the manual compression group, whereas no surgical intervention was required in the Prostar group. We conclude that the Prostar system for percutaneous vascular closure appears to be a safe technique for achieving an early hemostasis and ambulation after coronary intervention.     

Mobilization Within Thirty Minutes of Elective Diagnostic Coronary Angiography: A Feasibility Study Using a Hemostatic Femoral Puncture Closure Device

The standard procedure for obtaining hemostasis following coronary angiography is manual or mechanical compression of the femoral artery followed by 4–6 hours supine rest. The patient is then mobilized and later discharged. This consumes time and resources and may be uncomfortable for the patient. The aim of this pilot study was to determine if the Angio-Seal^TM hemostatic puncture closure device (the Angio-Seal device) allows safe, early mobilization of patients undergoing elective coronary angiography. Selected patients were randomly allocated to the the Angio-Seal device (study group, n = 24) or standard compression techniques (control group, n = 26) after completion of the diagnostic coronary angiogram. Study group patients were mobilized 25–30 minutes after sheath removal and deployment of the Angio-Seal device. After hemostasis in control patients, a pressure bandage was applied, and the patient was placed on bed rest for 4–6 hours. There was no age or sex difference between the study group and the control group. There were more patients with hypertension, diabetes mellitus, or obesity in the control group. Time to hemostasis was 0.5 ± 1.4 min for the study group and 42.9 ± 20.6 min for the control group (P < 0.0001). Time to mobilization was 32.5 ± 6.9 min for the study group and 322.7 ± 41.8 for the control group (P < 0.0001), with 83% and 92% (P = NS) of patients in respective groups being fully mobilized according to protocol. Complications requiring clinical intervention were seen in three patients (12.5%) in the study group and in one patient (4%) in the control group. We have shown that mobilization of patients within 30 minutes of diagnostic coronary angiography via the femoral artery is feasible using the Angio-Seal device. The safety of this approach needs to be addressed in a larger randomized study.     

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     

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.     

经皮血管缝合器与人工压迫法对股动脉拔管术后止血效果的比较

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     

Efficacy of hemostatic puncture closing device for hemostasis and early ambulation after coronary angiography and angioplasty: results of a multicenter trial]

To assess the efficacy and safety of a hemostatic puncture closing device for reducing patient immobilization after cardiac catheterization from a percutaneous femoral artery approach, we conducted a prospective, randomized trial at 4 participating centers. A total of 240 patients (183 men, 57 women, mean age 61 +/- 10 yr; 157 patients underwent diagnostic angiography, 83 patients underwent coronary angioplasty) were randomized to either the device group (n = 120) or the manual compression group (n = 120). There were no statistical differences in age, gender, weight or sheath size between the 2 groups. A 7, 8F sheath was used in 53 patients of the device group and in 43 patients of the manual compression group. One hundred and two patients (85%) in the device group and 96 patients (80%) in the manual compression group received heparin. Protamine was used in one patient of the device group and 23 patients of the manual compression group. Activated clotting time just prior to sheath removal was 206 +/- 64 sec in the device group and 170 +/- 47 sec in the manual compression group (p < 0.01). Successful placement of the device was achieved in 118 of 120 patients (98%). Time to hemostasis was significantly shorter in the device group (0.8 +/- 3.2 vs 12.2 +/- 5.3 min, p < 0.01). Time to ambulation could be reduced in the device group (5.3 +/- 3.7 vs 10.9 +/- 5.1 hr, p < 0.01). The following complication rates occurred in the device group as compared with the manual compression group: hematoma, 16% vs 10%; bleeding, 8% vs 3%; pseudoaneurysm, 0% vs 1%, respectively. None of these differences was statistically significant. These results indicate that early ambulation using a hemostatic puncture closing device is feasible without significantly increasing the risk of peripheral vascular complications.     

Percutaneous suture closure for management of large French size arterial puncture in aortic valvuloplasty

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.     

Early ambulation after diagnostic cardiac catheterization: a 4 French study

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.     

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.     

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.     

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.     

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.     

Clinical effectiveness of the Prostar XL suture-mediated percutaneous vascular closure device following PCI: results of the Perclose AcceleRated Ambulation and DISchargE (PARADISE) Trial

BACKGROUND: The Prostar XL is a hemostasis device designed to percutaneously close the arterial puncture site with two nonabsorbable sutures. The Early Discharge and Economical effectiveness study for New hemostasis device (EDEN) trial, which was performed in Japan, showed that the Prostar XL device shortened time to hemostasis, time to ambulation and the average length of hospital stay, and decreased local vascular complications. However, the ooze of blood from the puncture site incision requires relatively longer time to ambulation. OBJECTIVES: The Perclose AcceleRated Ambulation and DISchargE (PARADISE) trial was performed to assess the effectiveness of the Prostar XL device on patient comfort, shortened time to ambulation and discharge from hospital by minimizing the oozing problem. METHODS: This multicenter, non-randomized registry was designed to compare times to hemostasis, ambulation and discharge, as well as the incidence of peripheral vascular complications in Prostar XL patients with the conventional manual compression group in the EDEN trial. Hydrochloride lidocaine containing 1% epinephrine was used as local anesthesia to reduce blood oozing. RESULTS: Between September 1999 and March 2000, a total of 109 patients were enrolled in this study. The closure device was successfully placed in 108 of 109 attempts. Time to hemostasis was significantly less than with the conventional manual compression group in the EDEN trial. Times to ambulation and discharge were significantly less than with the Prostar XL and conventional manual compression groups in the EDEN trial. CONCLUSION: We conclude that the Prostar XL device plus hydrochloride lidocaine containing 1% epinephrine as local anesthesia appears to be a safe and effective method to achieve hemostasis, and to improve times to ambulation and discharge after interventional procedures.     

Novel femoral artery puncture closure device in patients undergoing interventional and diagnostic cardiac procedures.

BACKGROUND: The wide range of closure devices for arterial access sites still leaves room for improvement. METHODS AND RESULTS: We report our initial experience with a novel, cost-effective, suture-mediated device (6 French X-PRESS device, X-SITE Medical, Blue Bell, Pennsylvania) for closure of the arterial access site after both diagnostic and therapeutic interventions. A total of 51 consecutive patients are reported. The closure was performed immediately after the procedure. No patient had more than 5,000 U heparin administered during the procedure. The closure device was used in 36 patients (73%) after diagnostic angiography and in 15 patients (27%) after therapeutic intervention. The device could be successfully deployed in 48 patients (94%). In the remaining 3 cases (6%), hemostasis was achieved with standard manual compression without any further event. Immediate total hemostasis was achieved with the device in 44 of 48 patients (92%). Four devices (8%) could not be deployed correctly due to technical problems and the patients needed additional manual compression. The average time to achieve complete hemostasis was 5.5 +/- 3.5 minutes (range, 3-26 minutes). The patients were ambulated after a period of 1.3 +/- 0.4 hours of bedrest (range, 0.8-3.5 hours). Time to possible discharge was 4.2 +/- 3.4 hours (range, 0.9-12.5 hours). One patient experienced a minor complication (hematoma < 6 cm) and was treated with manual compression without clinical sequelae. Telephone follow-up was carried out 2 weeks after deployment and revealed no sequelae. CONCLUSION: The 6 French X-PRESS device is safe and effective in providing rapid hemostasis following interventional or diagnostic catheterization procedures. Use of the device is associated with a low rate of complications and facilitates quick hemostasis, mobilization and discharge.