StarClose SE Research Articles

Access site complications are uncommon with vascular closure devices or manual compression after lower extremity revascularization

ObjectiveVascular closure devices (VCDs) and manual compression (MC) are used to achieve hemostasis after peripheral vascular interventions (PVIs). We sought to compare perioperative outcomes between MC and four VCDs after PVI in a multicenter setting. MethodsThe Vascular Quality Initiative was queried for all lower extremity PVIs with common femoral artery access performed from 2010 to 2020. The VCDs included were MynxGrip (Cordis, Santa Clara, CA), StarClose SE (Abbott Vascular, Redwood City, CA), Angio-Seal (Terumo, Somerset, NJ), and Perclose ProGlide (Abbott Vascular). In a blinded fashion, these four VCDs (labeled A, B, C, and D) were compared to MC for baseline characteristics, procedural details, and outcomes (access site hematoma and stenosis/occlusion). Those with a sheath size >8F were excluded. Propensity score matching (1:1) was performed. Univariable and multivariable analyses were completed for unmatched and matched data. ResultsA total of 84,172 lower extremity PVIs were identified. Of these, 32,013 (38%) had used MC and 52,159 (62%) had used VCDs (A, 12,675; B, 6224; C, 19,872; D, 13,388). The average age was 68.7 years, and 60.4% of the patients were men. The most common indications for intervention were claudication (43.8%) and tissue loss (40.1%). Compared with MC, VCDs were used more often for patients with obesity, diabetes, and end-stage renal disease (P < .001 for all). VCDs were used less often for patients with hypertension, chronic obstructive pulmonary disease, coronary artery disease, prior percutaneous coronary and extremity interventions, and major amputation (P < .001 for all). VCD use was more common than MC during femoropopliteal (73% vs 63.8%) and tibial (33.8% vs 22.3%) interventions but less common with iliac interventions (20.6% vs 34.7%; P < .001 for all). Protamine was used less often with VCDs (19.1% vs 25.6%; P < .001). Overall, 2003 hematomas had developed (2.4%), of which 278 (13.9%) had required thrombin or surgical intervention. Compared with MC, the use of any VCD had resulted in fewer hematomas (1.7% vs 3.6%; P < .001) and fewer hematomas requiring intervention (0.2% vs 0.5%; P < .001). When divided by hemostatic technique, the rate of the development of any hematoma was as follows: MC, 3.6%; VCD A, 1.4%; VCD B, 1.2%; VCD C, 2.3%; and VCD D, 1.1% (P < .001). The rate of hematomas requiring intervention was as follows: MC, 0.5%; VCD A, 0.2%; VCD B, 0.2%; VCD C, 0.3%; and VCD D, 0.1% (P < .001). Access site stenosis/occlusion was similar between the MC and any VCD groups (0.2% vs 0.2%; P = .12). Multivariable analysis demonstrated that any VCD use and the use of the individual VCDs compared with MC were independently associated with the development of fewer hematomas. The incidence of access site stenosis/occlusion was similar between the use of any VCD and MC. The matched analysis revealed similar findings. ConclusionsAlthough the overall rates of hematomas requiring intervention were low regardless of hemostatic technique, VCD use, irrespective of type, compared favorably with MC, with significantly fewer access site complications after PVI.

Complications in places of percutaneous coronary interventions: comparison of manual compression and clip application devices to achieve hemostasis

Vascular closure devices, used for over 20 years as an alternative to manual compression to achieve hemostasis. Although the clinical effi cacy and safety of clip application devices type VCD have been confi rmed in several studies, their use remains controversial due to complications in the access by using these devices. The purpose of this study — comparing the frequency of formation of regional vascular complications , risk factors for these complications, hemostatic time, duration of immobilization, the period of stay in hospital and the patients comfort level after percutaneous coronary interventions (PCI) with the traditional manual hemostasis and using VCD. For a retrospective analysis of medical records were selected 246 adult patients from City Hospital of Moscow n.a. M.P. Konchalovskiy, SMRC in Moscow which was performed PCI. The main group, where hemostasis after endovascular procedures was achieved with the help of clip application device StarClose SE (Abbott Vascular), made up of 128 patients, control group — 118 patients with carrying out manual hemostasis. Evaluation of subjective sensations (pain, numbness, etc.) was carried out using a rating scale. The frequency of complications in the study group was 6.25% in the control group — 6.78%. The comfort level of patients was higher in the study group. The results showed that the use of StarClose device to achieve hemostasis after PCI does not increase the frequency of regional vascular complications compared with manual hemostasis. At the same time, the use of vascular closure devices is an eff ective way to reduce hemostasis time, can reduce the period of immobilization of the patient, which increases patient comfort and reduces the patient’s stay in the hospital.

Differences of bleedings after percutaneous coronary intervention using femoral closure and radial compression devices.

Bleedings represent most relevant complications being correlated with significant rates of adverse clinical outcomes in patients undergoing percutaneous coronary intervention (PCI). To reduce bleeding and improve prognosis various types of vascular closure devices (VCD) are frequently applied. This study aims to compare directly one specific femoral closure (FC) to one specific radial compression (RC) device in patients after PCI focusing on overall and access-site bleedings as well as major adverse cardiac events (MACE).This single-center, prospective, and observational study included consecutive patients either treated by the FC (StarClose SE) or RC (TR Band) device following PCI. The primary outcome was bleeding; the secondary outcomes were MACE at 30 days of follow-up.Two hundred patients in each group were enrolled following PCI. Access-site bleeding was significantly higher in the FC (43%) compared to the RC (30%) group (P = .001). Most common type of access-site bleeding consisted of hematomas. Of these, small and large hematomas were significantly higher in the FC group (P < .05). No significant differences of MACE were observed in both groups. In multivariable logistic regression models no consistent significant association of any risk factor with bleeding complications was identified.Despite the use of VCD, transfemoral arterial access is still associated with a higher rates of access site bleeding consisting mostly of hematomas compared to trans-radial access, whereas no differences of MACE were observed between FC and RC patients at 30 days follow-up.

Extravascular compared to Intravascular Femoral Closure is Associated with Less Bleeding and Similar MACE after Percutaneous Coronary Intervention

Background: Various types of vascular closure devices (VCDs) are frequently utilized in patients undergoing percutaneous coronary intervention (PCI) in order to prevent arterial access site bleeding, which represents one of the most relevant complications associated with adverse clinical outcomes. This study aims to compare directly two mechanistically different types of femoral closure (FC) devices in patients undergoing PCI.Methods: This single-center, prospective, observational study includes consecutively patients either treated by the extravascular StarClose SE® (Abbott, Illinois, U.S.A.) or the intravascular AngioSeal™ FC (St. Jude Medical, Inc., St. Paul, MN, U.S.A.) after PCI. The primary endpoint was bleeding complications, the secondary endpoint was major adverse cardiac events (MACE) at 30 days of follow-up.Results: 200 patients in each group (StarClose SE® and AngioSeal™) were enrolled following PCI. The rates of overall and non-access site bleedings were significantly higher in the AngioSeal™ group (56%; 6%) compared to the StarClose SE® group (43.5%; 0.5%) (p = 0.012; 0.003). Additionally, complicated access site bleedings were also significantly higher in the AngioSeal™ group (p = 0.011). No significant differences of MACE were observed in both groups. However, there was a higher rate of unsuccessful implantation of the StarClose SE® (n=12, excluded from the study).Conclusions: In case of successful implantation, FC by the AngioSeal™ is associated with the higher rate of both access and non-access site bleedings, but similar rates of MACE at 30 days compared to the StarClose SE® device.

Starclose SE® hemostasis after 6F direct antegrade superficial femoral artery access distal to the femoral head for peripheral endovascular procedures in obese patients.

Direct superficial femoral artery (SFA) antegrade puncture is a valid alternative to common femoral artery (CFA) access for peripheral vascular interventions. Data investigating vascular closure device (VCD) hemostasis of distant SFA 6F access are limited. We aimed to investigate the safety and effectiveness of the Starclose SE® VCD for hemostasis, following direct 6F antegrade SFA access distal to the femoral head. This prospective, single-center study included patients who were not suitable for CFA puncture and were scheduled to undergo peripheral endovascular interventions using direct antegrade SFA 6F access, at least 2 cm below the inferior edge of femoral head. Hemostasis was obtained with the Starclose SE® VCD (Abbott Laboratories). Primary endpoints were successful hemostasis rate and periprocedural (30-day) major complication rate. Secondary endpoint was the rate of minor complications. Clinical and Doppler ultrasound follow-up was performed at discharge and at one month. Between September 2014 and August 2015, a total of 30 patients (21 male; 70.0%) with a mean body mass index of 41.2 kg/m2 were enrolled. Mean age was 72±9 years (range, 67-88 years). Most patients suffered from critical limb ischemia (87.1%) and diabetes (61.3%). Calcifications were present in eight cases (26.6%). Reason for direct SFA puncture was obesity (100%). Successful hemostasis was achieved in 100% of the cases. No major complications were noted after one-month follow-up. Minor complications included two <5 cm hematomas (6.6%) not necessitating treatment. In this prospective study, Starclose SE® VCD was safe and effective for hemostasis of antegrade direct SFA puncture. Uncomplicated hemostasis was achieved even in cases of puncturing 2 to 7 cm below the inferior edge of the femoral head.

Nitinol clip distal migration and resultant popliteo-tibial artery occlusion complicating access closure by the StarClose SE vascular closure system

Lower extremity ischemia following deployment of a vascular closure device for access site closure after a transfemoral endovascular procedure rarely occurs. A 68-year-old woman diagnosed with subarachnoid hemorrhage due to...

Central Pseudo-Aneurysm Formation Following Arterial Closure with a StarClose SE Device: When a StarClose Doesn’t Completely Close

Vascular closure devices are frequently used for hemostasis during endovascular procedures by employing sutures, plug devices (using collagen or hydrogel) or through the use of a metal clip made of nickel and titanium as with the StarClose device. We present a case where a StarClose SE vascular closure device (VCD) was deployed for hemostasis post diagnostic cardiac catheterization and upon repeat access, four days later for coronary intervention, retrograde sheath angiography revealed a pseudo-aneurysm emanating from the center of the StarClose clip. Review of literature indicates StarClose to be safe and effective in achieving hemostasis in majority of endovascular procedures and the incidence of pseudo-aneurysm to be infrequent.

Angioseal VIP® vs. StarClose SE® closure devices: a comparative analysis in non-cardiological procedures

The aim of this paper was to compare the use of two different commercially available vascular closure devices (VCD), Angioseal VIP® (St. Jude Medical, St. Paul, MN, USA) and StarClose SE (Abbott Laboratories, Abbott Park, IL, USA). From January 2010 to January 2012, 347 patient underwent retrograde femoral arterial puncture for different interventional procedures (angioplasty, stenting, embolization for bleeding, fibrinolysis for ischemia and chemoembolization). Hemostasis was achieved by deployment of an Angioseal VIP® (N.=184) or StarClose SE® (N.=163). In 94 cases, the retrograde femoral access was bilateral and managed with two StarClose SE devices (N.=53) or an Angioseal VIP® plus a StarClose SE® (N.=41). Technical success was obtained in 95.1% (330/347) of patients. Overall time to hemostasis (TTH) and time to ambulation (TTA) were 5,5±1,5 min (range 3-8 min) and 6±2.5 hr (range 2-9 hours) respectively. No statistical significative difference (P>0.05) were appreciable between to groups for both TTH and TTA: Angioseal VIP® TTH was 5.3±1.4 min and StarClose SE® TTH was 5.6±1.6 min; Angioseal VIP® TTA was 5.9±1.8 hr and StarClose SE® TTA was 6.1±1.9 hr. VAS scores result underline a mild difference between two devices. Angioseal VIP® patients experience a mild to moderate pain within the first 3 minutes from the deployment. Whereas StarClose SE® patients still experience pain at 5 minutes from deployment. The device failure rate was 4.9% (17 cases) and included 13 minor complications and 4 major complications. Minor complications (3.75%) occurred during the initial phase and consisted in recurrent wound bleeding (N.=5 StarClose SE®; N.=4 Angioseal VIP®) treated with manual compression, and hematoma (N.=2 StarClose SE®; N.=2 Angioseal VIP®) that solved spontaneously. The 4 major complications (1,15%) were: 1 Angioseal-related common femoral artery (CFA) obstruction treated with surgical bypass from the CFA to the superficial femoral artery; 1 Angioseal-related CFA dissection solved with surgery; 1 Angioseal-related embolization of the deep femoral artery partially treated with localized fibrinolysis; 1 StarClose-related pseudoaneurysm treated with manual compression. Both Angioseal VIP® and StarClose SE® systems can be considered safe and effective in providing hemostasis following a variety of interventional vascular procedures.

Distribution of Reported StarClose SE Vascular Closure Device Complications in the Manufacturer and User Facility Device Experience Database

PurposeTo evaluate the type and frequency of complications associated with the StarClose SE vascular closure device reported to the U.S. Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database for comparison with complications reported in clinical trials. Materials and MethodsComplications reported in the MAUDE database related to use of the StarClose SE vascular closure device were reviewed. Keyword searches by device and manufacturer were performed for a 16-month period from July 2009–October 2010. Reports were analyzed according to complication type, frequency, and resolution, if specified. These data were compared with data on StarClose SE device complications, which included three prospective randomized trials and five prospective nonrandomized trials. ResultsKeyword searches returned 1,107 total records and 1,118 categorizable StarClose SE device complications from the 16-month MAUDE database–reporting period. Complications in order of frequency (absolute number and relative frequency, respectively) included failure to achieve hemostasis (409, 36.6%), inability to complete the deployment sequence (268, 24.0%), entrapped deployment device (224, 20%), clip not deployed (151,13.5%), late bleeding or oozing from dermatotomy site (25, 2.2%), vessel occlusion (19, 1.7%), retroperitoneal hematoma (12, 1.1%), pseudoaneurysm formation (6, 0.5%) and death (4, 0.4%). The distribution of complications differed appreciably from the combined adverse events compiled from the published trials evaluating the StarClose SE device. There were no records describing inability to remove the deployment device in the published trials, whereas this represented the third most common complication reported to the MAUDE database. Bleeding or oozing from the dermatotomy site, the most frequent relative complication reported in the published literature (53.4%), represented 2.2% of the total complications reported to the MAUDE database. ConclusionsThe type and frequency of complications reported in the MAUDE database on the StarClose SE vascular closure device differ from those published in clinical trials both in relative distribution and in type. Although these differences may reflect in part reporting biases, the distribution of complications reported to the MAUDE database may represent useful information in the use of this device.

Safety and Efficacy of StarClose SE Vascular Closure System in High-Risk Liver Interventional Oncology Patients

To assess the safety and efficacy of the StarClose SE Vascular Closure System (Abbott Vascular, Abbott Park IL, USA) in high-risk thrombocytopenic and coagulopathic interventional oncology (IO) patients. In this single institution retrospective study, 63 high-risk thrombocytopenic or coagulopathic IO patients (M:F=51:12, mean age 58 years, range 31-88 years) who underwent 83 common femoral arteriotomy closures using the StarClose device were identified among all IO patients (n=131) undergoing StarClose closure (n=177) between 2008-2011. High-risk thrombocytopenia and coagulopathy were defined as platelet count ≤100 10(3)/mL and international normalized ratio (INR) ≥1.5. Procedures included chemoembolization (n=67), radioembolization (n=8), and hepatic arterial mapping with technetium-99m macroaggrated albumin administration (n=8) for treatment of hepatocellular carcinoma (n=79) or liver metastases (n=4). Measured outcomes included technical success of arterial closure and closure-related adverse events, graded according to the Society of Interventional Radiology classification. In all cases, 5 French common femoral arterial access was used. Platelet count was ≤100 10(3)/mL in 80/83 (96.4%) cases and INR was ≥1.5 in 35/83 (42.2%) cases. Mean pre-procedure platelet count was 71 (range 26-347) 10(3)/mL and mean INR was 1.4 (range 1.0-2.1). The StarClose device effectively sealed the arteriotomy in 83/83 (100%) cases, 60/83 (72.3%) cases were first-time closures, and 20/83 (24.1%) cases were repeat closures. Small groin hematomas, graded as class A minor complications, developed in 3/83 (3.6%) cases. No other complications were encountered. The StarClose SE Vascular Closure System confers high technical success and safety in common femoral arteriotomy closure in high-risk IO patients.