Initial experience with the Cardiva Boomerang vascular closure device in diagnostic catheterization.

OBJECTIVES: The authors studied the safety and efficacy of the Cardiva Boomerang vascular closure device in patients undergoing diagnostic cardiac catheterization. BACKGROUND: Conventional vascular closure devices (sutures, collagen plugs, or metal clips) have been associated with catastrophic complications including arterial occlusion and foreign body infections; furthermore, they cannot be utilized in patients with peripheral vascular disease or vascular access site in a vessel other than the common femoral artery. The Cardiva Boomerang device facilitates vascular hemostasis without leaving any foreign body behind at the access site, can be used in peripheral vascular disease, and can be used in vessels other than the common femoral artery METHODS: A total of 96 patients undergoing transfemoral diagnostic cardiac catheterization were included in this study, including 25 (26%) patients with contraindications to conventional closure devices. Femoral angiography was performed prior to deployment of the Cardiva Boomerang closure device. Patients were ambulated at 1 hr after hemostasis was achieved. RESULTS: The device was successfully deployed and hemostasis achieved with the device alone in 95 (99%) patients. The device failed to deploy in 1 (1%) patient and required conversion to standard manual compression. Minor complications were observed in 5 (5%) patients. No patients experienced major complications including femoral hematoma > 4 cm, red blood cell transfusion, retroperitoneal bleed, arteriovenous fistula, pseudoaneurysm, infection, arterial occlusion, or vascular surgery. CONCLUSIONS: The Cardiva Boomerang device is safe and effective in patients undergoing diagnostic cardiac catheterization using the transfemoral approach, facilitating early ambulation with low rates of vascular 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.     

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.     

Femoral artery access site closure with perclose suture mediated device in coronary interventions

ObjectiveTo compare the outcome of suture mediated vascular closure device Perclose Proglide (PP) with manual compression (MC) following transfemoral access for coronary interventions (CI).MethodsIt is a retrospective, observational, single centre study from January 2018 to September 2019. Consecutive patients undergoing interventions through transfemoral access were divided into PP and MC groups. Those with less than 3 months follow up were excluded. Two groups were compared for baseline characteristics and various complications at 24 h and at 30 days.ResultsOut of 1743 patients studied, PP group included 1343 and MC group, 400 patients. Both groups were comparable in baseline characteristics, sheath size and use of antiplatelets and anticoagulation. PP group had significantly less minor bleeding (P = .01, CI 0.34–4.03) and hematoma (P = .0007, CI 0.95–5.10) at 24 h. At 30 days, minor bleeding (P < .0001, CI 0.97–4.25), hematoma (P = .0002, CI 1.05–4.93) and pseudo-aneurysm (P = .0095, CI 0.03–1.18) were also significantly less in PP group. Obesity (OR 3.5, CI 1.29–9.49) and hypertension (OR 2.41, CI 1.12–5.19) were associated with increased minor bleeding at 24 h. Device failure rate was 2.38%.ConclusionsPP device is safe, effective and is associated with fewer complications than MC in CI. Device failure rate is low. Obesity and hypertension are associated with increased minor bleeding in both groups.     

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.     

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。     

Common femoral artery stenosis after deployment of vascular clip closure device

We describe a case of symptomatic common femoral artery stenosis following use of a vascular clip closure device (StarClose). Operative repair was performed, with removal of the clip device and subsequent vein patch angioplasty. © 2008 Wiley‐Liss, Inc.     

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.     

冠脉介入术后Angioseal血管缝合与压迫止血的对比研究

目的　评价Angioseal缝合器止血的实用性。方法　 2 0 0 2 - 10～ 2 0 0 3- 0 7所做的冠状动脉造影或介入治疗病例共 2 6 0例 ,其中冠状动脉造影 15 0例 ,介入治疗 110例。按止血方法不同分为传统压迫止血组和血管缝合组。结果　 (1)缝合法与压迫法止血时间及下肢制动时间的比较。单纯冠状动脉造影止血时间分别为 :缝合法(1 8± 0 9)min ,压迫法 (2 5 3± 13 4 )min ,两者差异有非常显著性 (P <0 0 0 1) ;下肢制动时间分别为 :缝合法 (3 8± 0 8)h ,压迫法 (13 4± 2 2 )h ,两者差异有非常显著性 (P <0 0 0 1) ;介入治疗后止血时间 :缝合法与压迫法分别为 (2 0± 1 1)min及 (2 9 5± 14 3)min ,两者差异有非常显著性 (P <0 0 0 1) ;下肢制动时间缝合法与压迫法分别为(4 3± 1 5 )h及 ,(2 4 3± 3 2 )h ,两者差异有非常显著性 (P <0 0 0 1)。 (2 )压迫法术后各类并发症如出血、血肿、迟发出血 (第 3天以后 ,至 1周 )、迷走反射、皮肤溃烂等 ,明显高于缝合法 (P <0 0 0 1)。结论　Angioseal缝合器止血简便、实用、安全。     

Reduced vascular complications after percutaneous coronary interventions with a nonmechanical suture device: results from the randomized RACE study.

The objective of this study was to evaluate the safety and efficacy of a novel nonmechanical percutaneous suture device, X-Press, after diagnostic catheterization and percutaneous coronary interventions (PCIs) in the setting of glycoprotein IIb/IIIa inhibitor usage. Current percutaneous vascular suture devices remain mechanically complex and expensive and have not been shown to reduce major vascular complications. Using a 2:1 randomization scheme (2:1 ratio, device vs. compression), 393 patients undergoing diagnostic catheterization (n = 133) or PCI (n = 260) were randomized in the prospective Rapid Ambulation After Closure (RACE) study and evaluated for time to ambulation, time to hemostasis, treatment success, and incidence of major vascular complications. Glycoprotein IIb/IIIa inhibitors were used in 52% of PCI patients. There was a significant reduction in the primary efficacy endpoint of median time to ambulation for device compared to control with both diagnostic (2.2 vs. 6.2 hr; P = 0.0001) and PCI patients (4.1 vs. 14.7 hr; P = 0.0001). Device malfunction occurred in 3.1% patients without clinical sequalae. Equivalence in the primary safety endpoint, the incidence of major complications (vascular repair, ultrasound-guided compression, transfusion, or infection) at 14 days, was observed with the X-Press device (1/261; 0.4%) compared to control (3/132; 2.3%; P = 0.11). In PCI patients, half of whom received glycoprotein IIb/IIIa inhibitors, there was a significant reduction in the incidence of vascular complications in patients using the device (0/172; 0%) compared to control (3/88; 3.4%; P = 0.037). In diagnostic catheterization and PCI, a novel nonmechanical suture device reduced the time to ambulation and demonstrated equivalence in major complications compared to conventional compression techniques. The incidence of major complications after PCI was reduced with the 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.     

Re‐access complication with a starclose device

Diagnostic cardiac catheterizations are predominantly performed using access through the femoral artery. To improve patient comfort and early mobilization, a number of percutaneous closure devices have been developed. One such device using the nitinol clip was developed by Abbott Vascular Devices and was approved for use on the basis of the results of the Clip Closure In Percutaneous Procedures (CLIP) study. The safety of repuncture through a previously deployed device has not been established in humans. We present the case of a patient who had an arterial line placed for post‐operative monitoring after cardiac surgery at the site of a previous arteriotomy closed with the Starclose device. The catheter traversed through the central portion, tethered to the periphery of the ninitol clip, and required surgery for extraction. © 2009 Wiley‐Liss, Inc.     

Comparison of closure strategies after balloon aortic valvuloplasty: Suture mediated versus collagen based versus manual

Objectives : To compare complication rates of a collagen‐mediated closure device, suture‐mediated closure technique and manual compression for access site management following balloon aortic valvuloplasty (BAV). Background : Vascular complications, including perforation, limb ischemia, ateriovenous fistulas, and pseudoaneurysm, are a common source of morbidity in patients undergoing BAV with large bore femoral artery access. The available options for closure of the access site include manual compression, suture‐mediated closure devices, and recently reported collagen‐based closure devices. Methods : The study cohort consisted of 333 patients with severe aortic stenosis undergoing BAV. Patients were divided into four groups according to access closure method: (1) Manual compression in 64 (19.2%); (2) Proglide 6 Fr in 162 (48.6%); (3) Angio‐Seal 8 Fr in 89 (26.75%); and (4) Prostar 10 Fr in18 (5.4%). Results : There were no significant differences in baseline characteristics among the groups; although the Prostar group was had more males and the Angio‐Seal group reported a lower incidence of renal failure and peripheral vascular disease. The Angio‐Seal group had shorter procedural duration times compared with the other groups. In the Angio‐Seal group (n = 47, 52.8%), a 10 Fr sheath size was primarily used to access the femoral artery, as compared with the manual compression and Proglide groups, which used a 12 Fr sheath in 29 (45.3%) and 66 patients (40.7%), respectively. A 13 Fr sheath was used in the Prostar group (n = 11, 61.1%), P < 0.001. The device failure rate was significantly higher in the Proglide group (n = 20, 12.3%) as compared with Angio‐Seal (n = 3, 3.3%) and Prostar groups (n = 1, 5.5%), P = 0.03. Serious vascular complications requiring intervention were significantly higher in the manual compression group (n = 11, 17.1%) compared with the Proglide (n = 11, 6.7%), Angio‐Seal (n = 5, 5.6%), and Prostar groups (n = 5, 1%), P < 0.001. The requirement for blood transfusion in the Angio‐Seal group was significantly lower (n = 7, 7.8%) as compared with the manual compression (n = 20, 31.2%), Proglide (n = 35, 21.6%), and Prostar groups (n = 5, 27.7%), P < 0.001. Conclusion : In our case series, collagen‐based closure devices and suture‐mediated closure devices had fewer vascular complications than manual compression for hemostasis following BAV. Patient selection for collagen‐based versus suture‐mediated closure requires further study. © 2011 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.     

Percutaneous closure of paravalvular leak after Cone repair for Ebstein's anomaly

We report the use of an Amplatzer Vascular plug for percutaneous closure of a paravalvular leak after Cone repair in a 5‐year‐old boy with Ebstein's anomaly. A paravalvular leak of the tricuspid valve developed gradually after Cone repair‐surgery. The combination of fluoroscopy, transesophageal and transthoracic imaging during general anesthesia was necessary for correct and safe positioning of the device by percutaneous approach. The results were promising.     

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.     

Randomized comparison of Vasoseal and Angioseal closure devices in patients undergoing coronary angiography and angioplasty.

AngioSeal (AS) and VasoSeal (VS) are collagen-based arterial closure devices utilized to achieve earlier hemostasis and ambulation in diagnostic and interventional percutaneous procedures. To our knowledge, there has been no randomized studies comparing these two devices as approved for use in the United States. One hundred fifty-seven patients were randomized to receive either the 8 Fr AS (n = 79) or VS (n = 78) closure device. Data on 95 patients who had coronary angiography (49 AS, 46 VS) and 55 patients who underwent angioplasty (28 AS, 27 VS) were completed. Heparin was not administered during the coronary angiogram procedure. The activated clotting time was kept at approximately 300 sec during angioplasty. Patients on coumadin or GP IIb/IIIa platelet inhibitors were not included in this study. The time unit interval to achieve hemostasis in this study was based on the time the AS tension spring was left over the common femoral artery following collagen deployment as per the manufacturer's instructions (20 min). Time to hemostasis, time to ambulation, and major and minor complications were prospectively recorded. Two-tailed t-test and chi-square analysis were performed on continuous and dichotomous variables, respectively. For the angiogram-only subgroup, time (min) to hemostasis (20.51 +/- 4.36 vs. 18.59 +/- 11.77; P = 0.30) and ambulation (145.71 +/- 124 vs. 109.89 +/- 60.37; P = 0.075) were not statistically different for the AS and VS, respectively. Similarly, for the angioplasty subgroup, time (min) to hemostasis (24.23 +/- 12.70 vs. 19.57 +/- 2.27; P = 0.077) and ambulation (607.32 +/- 344.22 vs. 486.48 +/- 200.37; P = 0.12) were not statistically different for both AS and VS, respectively. Furthermore, there were no statistical differences in deployment failure, major, minor, or total complication rates between the two devices. In the absence of GP IIb/IIIa inhibitors, VS and the 8 Fr AS devices have statistically similar time to hemostasis and ambulation as well as device failures and complication rates following coronary angiography and angioplasty.     

心导管术拔鞘管后应用经皮血管闭合器疗效观察

目的　比较心血管病患者心导管术拔鞘管后采用经皮血管闭合器 (Angio Seal)止血与人工压迫止血的安全性和疗效。方法　 197例心血管病患者在行心导管术后 ,分为人工压迫止血组(99例 ,其中冠状动脉造影 5 5例 ,冠状动脉介入术 4 4例 )和Angio Seal止血组 (98例 ,冠状动脉造影5 4例 ,冠状动脉介入术 4 4例 ) ,分别应用人工压迫止血和Angio Seal止血 ,观察两组止血时间、下床走动时间和血管并发症。结果　Angio Seal止血组与人工压迫止血组相比 ,止血时间与下床走动时间显著缩短。血管并发症发生率两组无显著差异。应用Angio Seal止血的成功率达 96 %。结论　心导管术后应用经皮血管闭合器缩短了止血与下床走动时间 ,并可能减少穿刺点并发症和病人不适感。