Safety and efficacy study of the wound care 360° SiteSeal® vascular closure device in percutaneous cardiac catheterization procedures

Vascular ◽  
2020 ◽  
pp. 170853812093457
Author(s):  
Suresh Sharma ◽  
Nilay Patel ◽  
Vinodh Jeevanantham ◽  
Kamal Gupta ◽  
Matthew B Earnest
Keyword(s):  
Cardiac Catheterization ◽  
Wound Care ◽  
Bleeding Event ◽  
Vascular Complication ◽  
Patient Comfort ◽  
Closure Device ◽  
Manual Compression ◽  
Safety And Efficacy ◽  
Diagnostic Cardiac Catheterization ◽  
Single Center Study

Objectives Vascular access site complications after percutaneous transfemoral cardiovascular procedures remain a common cause of morbidity and mortality. We evaluated the SiteSeal® VCD for achieving hemostasis following diagnostic cardiac catheterization. Methods We conducted a prospective case control single center study to assess the safety and efficacy of SiteSeal® VCD compared to standard manual compression following diagnostic cardiac catheterization. Forty patients were enrolled in study to receive either SiteSeal® device or manual compression (20 in each group). Results Patients in the SiteSeal® group achieved hemostasis in a significantly shorter time (4 ± 2.4 vs. 19 ± 2.4 min, P < 0.001), had shorter time from hemostasis to ambulation (95 ± 44 vs. 388 ± 63 min, P < 0.001) and significantly earlier device deployment to discharge time compared to the manual compression group (4.7 ± 1.1 vs. 8.9 ± 4.8 h, P = 0.001). There was one non-major bleeding event in the SiteSeal® group which occurred >24 h after discharge from the hospital and was managed conservatively. In the remaining device patients, there was no clinical or Doppler ultrasound evidence of major or minor vascular complication with good overall patient comfort at discharge, 7 days and 30 days follow-up. Conclusions In this first clinical experience, the SiteSeal® VCD achieved safe and efficient hemostasis, allowed for earlier ambulation and faster discharge compared to manual compression.

Use of vascular closure devices for endovascular interventions requiring a direct puncture of PETE grafts

VASA ◽  
2018 ◽  
Vol 47 (2) ◽  
pp. 119-124 ◽  
Author(s):  
Artur I. Milnerowicz ◽  
Aleksandra A. Milnerowicz ◽  
Marcin Protasiewicz ◽  
Wiktor Kuliczkowski
Keyword(s):  
Statistical Significance ◽  
Vascular Complications ◽  
Vascular Complication ◽  
Inguinal Region ◽  
Closure Device ◽  
Manual Compression ◽  
Direct Puncture ◽  
Endovascular Interventions ◽  
Vascular Closure Devices ◽  
Closure Group

Abstract. Background: Effectiveness of vascular closure devices during endovascular procedures requiring a direct puncture of a vascular prosthesis placed in the inguinal region is unknown. Patients and methods: The retrospective analysis included 134 patients with a history of polyethylene terephthalate (PETE) graft implantation in the inguinal region. In 20 (15 %) patients, haemostasis was achieved with manual compression, in 21 (16 %) with the StarClose™, and in 93 (69 %) with the AngioSeal™ device. Results: The incidence of vascular complications in the manual compression group was higher (at a threshold of statistical significance) than in the device closure group (45.0 vs. 24.5 %, p = 0.059). The difference was considered statistically significant when manual compression was compared with the AngioSeal™ closure group (45.0 vs. 13.9 %, p < 0.01). The vascular complication rate in the StarClose™ group was significantly higher than in the AngioSeal™ group (71.4 vs. 13.9 %, p < 0.000001). While haematomas were the only vascular complications observed after application of AngioSeal™, both haematomas and pseudoaneurysms were found in the StarClose™ group. Conclusions: The AngioSeal™ vascular closure device provides better local haemostasis than the StarClose™ device or manual compression during endovascular interventions requiring a direct puncture of PETE grafts

Manual versus mechanical compression for femoral artery hemostasis after cardiac catheterization

1998 ◽  
Vol 7 (4) ◽  
pp. 308-313 ◽  
Author(s):  
A Simon ◽  
B Bumgarner ◽  
K Clark ◽  
S Israel
Keyword(s):  
Cardiac Catheterization ◽  
Femoral Artery ◽  
Vascular Complications ◽  
Control Group ◽  
Mechanical Compression ◽  
Success Rates ◽  
Manual Compression ◽  
Diagnostic Cardiac Catheterization ◽  
Compression Time ◽  
Catheterization Procedure

BACKGROUND: Most cardiac catheterizations are performed via femoral artery access. Reported rates of both peripheral vascular complications and success rates for the use of manual and mechanical compression techniques to achieve femoral artery hemostasis after cardiac catheterization vary. OBJECTIVE: To determine is use of a mechanical clamp is as effective as standard manual pressure for femoral artery hemostasis after cardiac catheterization. METHODS: Subjects consisted of 720 patients from 2 community hospitals who had elective diagnostic cardiac catheterization via the femoral artery. The control group (n=343) received manual compression for hemostasis; the study group (n=377) received mechanical compression. Standard protocols were used for the 2 compression techniques. Pressure was applied for a minimum of 10 minutes for 5F and 6F sheaths and catheters and for a minimum of 15 minutes for 7F and 8F sheaths and catheters. Prospective data were collected and analyzed for each patients, including sheath or catheter size, blood pressure, height, weight, age, time from administration of local anesthetic to successful cannulation of the femoral artery, anticoagulation status, total compression time, physician performing the catheterization procedure, nurse or technician who obtained hemostasis, and complications. In follow-up, patients were asked site-specific and functional status questions 1 to 2 days after the catheterization procedure and again 3 days after the catheterization procedure. RESULTS: Data were analyzed by using frequency distributions, measures of central tendency, and measures of variability. Only 1 difference between the 2 groups was significant: manual compression time was 14.93 +/- minutes, whereas mechanical compression time was 17.13 +/- minutes. CONCLUSION: Mechanical compression is as effective as manual compression for femoral artery hemostasis after cardiac catheterization.

Off-label use of the Angioseal vascular closure device for femoral arteriotomy: retrospective analysis of safety and efficacy

2016 ◽  
Vol 9 (10) ◽  
pp. 982-985 ◽  
Author(s):  
Sumedh S Shah ◽  
Giancarlo Perez ◽  
Brian M Snelling ◽  
Diogo C Haussen ◽  
Samir Sur ◽  
...  
Keyword(s):  
Closure Device ◽  
Manual Compression ◽  
Off Label Use ◽  
Safety And Efficacy ◽  
Off Label ◽  
Clinical Complications ◽  
Manual Pressure ◽  
Neurointerventional Procedures ◽  
Efficacy Profile ◽  
Label Use

BackgroundAngioseal, an arteriotomy closure device (ACD), functions as a collagen plug that physically closes arteriotomy sites and can simultaneously induce platelet activation and aggregation. When used ‘on-label’, the safety and efficacy profile of Angioseal is superior compared with those of other ACDs. However, Angioseal is sometimes deployed in less than ideal situations. Therefore, we sought to assess the safety and efficacy of ‘off-label’ Angioseal use in patients undergoing femoral arteriotomies.MethodsWe performed a retrospective review of all femoral arterial angiograms executed at our institution between 2008 and 2014. Patients whose femoral punctures did not fit the criteria for on-label Angioseal use were included, and were dichotomized based on vascular closure (off-label Angioseal vs manual compression).ResultsOf the 521 patients (1023 angiograms) reviewed, 303 (58.2%) patients had off-label Angioseal groin punctures. Mean patient age was 46.2±14.0 years, and 113 were men. 234 patients (77%) had off-label Angioseal deployment while 69 (22%) individuals received manual pressure, serving as controls. Demographic and procedural variables were nearly identical between the two groups but the Angioseal group comprised mostly patients that underwent neurointerventional procedures and thus received intraprocedural heparinization (41%) more often than the manual compression group (19%). The overall rate of major complications associated with off-label Angioseal deployment was low (<0.85%), and clinical complications were not independently associated with Angioseal use (OR 0.76 (95% CI 0.06 to 8.86); p=0.69).ConclusionsOff-label use of Angioseal was found to be safe and was not associated with an increased complication rate in our cohort.

scholarly journals Angio-Seal™ Embolization: A Rare Etiology of an Acute Distal Limb Ischemia

2017 ◽  
Vol 2017 ◽  
pp. 1-3 ◽  
Author(s):  
Glenmore Lasam ◽  
Joshua Brad Oaks ◽  
Jeffrey Brensilver
Keyword(s):  
Compartment Syndrome ◽  
Femoral Artery ◽  
Popliteal Artery ◽  
Lower Limb ◽  
Limb Ischemia ◽  
Vascular Complication ◽  
Closure Device ◽  
Lower Limb Ischemia ◽  
Diagnostic Cardiac Catheterization ◽  
The Right

We herein report a serious vascular complication of diagnostic cardiac catheterization due to an embolization of an Angio-Seal closure device causing acute lower limb ischemia. The Angio-Seal was deployed via the right femoral artery following the catheterization which embolized several hours later to the right popliteal artery. Fogarty embolectomy restored perfusion to the right lower limb; however, compartment syndrome subsequently developed which required evacuation of a hematoma and repair of right popliteal artery.

Sa1628 Safety and Efficacy of Overtubes for Preventing Cutaneous Metastasis During PEG Tube Placement in Patients With Head and Neck Cancer: a Single-Center Study

2014 ◽  
Vol 79 (5) ◽  
pp. AB280
Author(s):  
Crispin O. Musumba ◽  
Chiao-Yun (Julia) Hsu ◽  
Golo Ahlenstiel ◽  
Nicholas J. Tutticci ◽  
Kavinderjit S. Nanda ◽  
...  
Keyword(s):  
Head And Neck Cancer ◽  
Head And Neck ◽  
Neck Cancer ◽  
Cutaneous Metastasis ◽  
Tube Placement ◽  
Single Center ◽  
Safety And Efficacy ◽  
Single Center Study ◽  
Peg Tube ◽  
Center Study
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