Skip to main content
Key Specialties
Cardiology Diabetology Endocrinology Gastroenterology Geriatrics and Gerontology Gynecology and Obstetrics Hematology Infectious Disease Internal Medicine Nephrology Neurology Oncology Pediatrics Respiratory Medicine Rheumatology Surgery
Congress Coverage
2024 ACC Congress 2023 ESMO Congress 2023 EASD Congress 2023 ERS Congress 2023 ESC Congress 2023 EHA Congress 2023 ASCO Annual Meeting
Clinical Collections
Advances in Alzheimer’s

At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
ADVANCED SEARCH
Log in
Top
CardioVascular and Interventional Radiology
Published in: CardioVascular and Interventional Radiology 3/2014

01-06-2014 | Clinical Investigation

Safety and Efficacy of a Circumferential Clip-Based Vascular Closure Device in Cirrhotic and Coagulopathic Patients with Hepatocellular Carcinoma After Doxorubicin Drug-eluting Beads Transarterial Chemoembolization

Authors: Hasmukh J. Prajapati, Shoaib Rafi, Faramarz Edalat, David A. Kooby, Hyun S. Kim

Published in: CardioVascular and Interventional Radiology | Issue 3/2014

Login to get access

Abstract

Purpose

This study was designed to investigate the safety and efficacy of the circumferential clip-based (StarClose) vascular closure device (VCD) in coagulopathic and cirrhotic patients with hepatocellular carcinoma (HCC) after doxorubicin drug-eluting beads transarterial chemoembolization (DEB TACE).

Methods

Consecutive cirrhotic patients with HCC, who underwent DEB TACE from November 2009 to February 2012, were included in the study. Based on platelet count (PC) and international normalized ratio (INR), these patients were further divided into group A (PC ≥ 150 k/dl), B (PC = 50–149 k/dl), C (PC < 50 k/dl), D (INR ≤ 1.2), E (INR = 1.21–1.5), and F (INR > 1.5). StarClose VCD was attempted in each case. Technical success was defined as complete hemostasis achieved within 3 min after the closure. Periprocedural complications were studied.

Results

A total of 350 DEB TACEs were performed in 195 patients (mean age 61.6 years, SD 9.1). StarClose VCD was attempted in all cases. StarClose device was not deployed in 2.2 % (8/350) of cases due to improper femoral punctures and severe atherosclerotic disease. Technical success rate was 97.1 % (332/342). All groups (A–F) were similar in age, sex, body mass index, and technical success rate (P > 0.05). Minor complications occurred after 1.8 % (6/342) of cases. VCD was repeatedly used in 92 patients with 96.2 % (230/239) of technical success rate. There was no major complication related to VCD. There was no access site infection, leg ischemia, and pseudoaneurysm or symptomatic groin hematoma.

Conclusions

Circumferential clip based (StarClose) arterial closure device achieved effective and rapid hemostasis after DEB TACE with minimal complications in cirrhotic patients with HCC and coagulopathy. StarClose deployment and reaccess in patients with PC < 50 k/dl and INR > 1.2 are safe and effective.
Literature
1.
Lammer J, Malagari K, Vogl T et al (2010) Prospective randomized study of doxorubicin-eluting-bead embolization in the treatment of hepatocellular carcinoma: results of the PRECISION V study. Cardiovasc Interv Radiol 33(1):41–52CrossRef
2.
Malagari K, Chatzimichael K, Alexopoulou E et al (2008) Transarterial chemoembolization of unresectable hepatocellular carcinoma with drug eluting beads: results of an open-label study of 62 patients. Cardiovasc Interv Radiol 31(2):269–280CrossRef
3.
Dhanasekaran R, Kooby DA, Staley CA, Kauh JS, Khanna V, Kim HS (2010) Comparison of conventional transarterial chemoembolization (TACE) and chemoembolization with doxorubicin drug eluting beads (DEB) for unresectable hepatocellular carcinoma (HCC). J Surg Oncol 101(6):476–480PubMed
4.
Llovet JM, Real MI, Montana X et al (2002) Arterial embolisation or chemoembolisation versus symptomatic treatment in patients with unresectable hepatocellular carcinoma: a randomised controlled trial. Lancet 359(9319):1734–1739PubMedCrossRef
5.
Prajapati H, Spivey J, Hanish S et al (2012) mRECIST and EASL responses at early time point by contrast-enhanced dynamic MRI predict survival in patients with unresectable hepatocellular carcinoma (HCC) treated by doxorubicin drug-eluting beads transarterial chemoembolization (DEB TACE). Ann Oncol 24(4):965–973PubMedCrossRef
6.
Prajapati HJ, Dhanasekaran R, El-Rayes BF et al (2013) Safety and efficacy of doxorubicin drug-eluting bead transarterial chemoembolization in patients with advanced hepatocellular carcinoma. J Vasc Interv Radiol 24:307–315PubMedCrossRef
7.
Prajapati HJ, Rafi S, El-Rayes BF, Kauh JS, Kooby DA, Kim HS (2012) Safety and feasibility of same-day discharge of patients with unresectable hepatocellular carcinoma treated with doxorubicin drug-eluting bead transcatheter chemoembolization. J Vasc Interv Radiol 23(10):1286–1293 e1281PubMedCrossRef
8.
9.
Hoffer EK, Bloch RD (2003) Percutaneous arterial closure devices. J Vasc Interv Radiol 14(7):865–885PubMedCrossRef
10.
Sanborn TA, Gibbs HH, Brinker JA, Knopf WD, Kosinksi EJ, Roubin GS (1999) A multicenter randomized trial comparing a percutaneous collagen hemostasis device with conventional manual compression after diagnostic angiography and angioplasty. J Invasive Cardiol 11(Suppl B):6B–13BPubMed
11.
Kahn ZM, Kumar M, Hollander G, Frankel R (2002) Safety and efficacy of the Perclose suture-mediated closure device after diagnostic and interventional catheterizations in a large consecutive population. Catheter Cardiovasc Interv 55(1):8–13PubMed
12.
Hieb R, Neisen M, Hohenwalter E, Molnar J, Rilling W (2008) Safety and effectiveness of repeat arterial closure using the AngioSeal device in patients with hepatic malignancy. J Vasc Intervent Radiol 19(12):1704–1708CrossRef
13.
Jaff MR, Hadley G, Hermiller JB et al (2006) The safety and efficacy of the StarClose vascular closure system: the ultrasound substudy of the CLIP study. Catheter Cardiovasc Interv 68(5):684–689PubMed
14.
Hermiller JB, Simonton C, Hinohara T et al (2006) The StarClose vascular closure system: interventional results from the CLIP study. Catheter Cardiovasc Interv 68(5):677–683PubMed
15.
Branzan D, Sixt S, Rastan A et al (2009) Safety and efficacy of the StarClose vascular closure system using 7-F and 8-F sheath sizes: a consecutive single-center analysis. J Endovasc Ther 16(4):475–482PubMedCrossRef
16.
Desideri A, Tonello D, Coscarelli S, Alitto F, Daniotti A, Chioin R (2005) Early mobilization after percutaneous catheterization and vascular closure with a novel device (Star-Close). Am J Cardiol 96(10):1408–1409PubMedCrossRef
17.
Deuling JH, Vermeulen RP, Anthonio RA et al (2008) Closure of the femoral artery after cardiac catheterization: a comparison of Angio-Seal, StarClose, and manual compression. Catheter Cardiovasc Interv 71(4):518–523PubMed
18.
Spiliopoulos S, Katsanos K, Karnabatidis D, Diamantopoulos A, Nikolaos C, Siablis D (2011) Safety and efficacy of the StarClose vascular closure device in more than 1,000 consecutive peripheral angioplasty procedures. J Endovasc Ther 18(3):435–443PubMedCrossRef
19.
Hermiller J, Simonton C, Hinohara T et al (2005) Clinical experience with a circumferential clip-based vascular closure device in diagnostic catheterization. J Invasive Cardiol 17(10):504–510PubMed
20.
Imam A, Carter RM, Phillips-Hughes J, Boardman P, Uberoi R (2007) StarClose vascular closure device: prospective study on 222 deployments in an interventional radiology practice. Cardiovasc Intervent Radiol 30(4):738–742PubMedCrossRef
21.
Ratnam LA, Raja J, Munneke GJ, Morgan RA, Belli A-M (2007) Prospective nonrandomized trial of manual compression and Angio-Seal and Starclose arterial closure devices in common femoral punctures. Cardiovasc Intervent Radiol 30(2):182–188PubMedCrossRef
22.
Ruygrok PN, Ormiston JA, Stewart JT et al (2005) Initial experience with a new femoral artery closure device following percutaneous coronary intervention with glycoprotein IIb/IIIa inhibition. Catheter Cardiovasc Interv 66(2):185–191PubMed
23.
Tay EL, Co M, Tai BC et al (2008) Clinical experience of StarClose vascular closure device in patients with first and recurrent femoral punctures. J Interv Cardiol 21(1):67–73PubMedCrossRef
24.
Gaba R, Parvinian A, Trinos E (2012) Safety and efficacy of StarClose SE vascular closure system in high-risk liver interventional oncology patients. J Vasc Access 13(4):415–420PubMed
25.
26.
Bashour FN, Teran JC, Mullen KD (2000) Prevalence of peripheral blood cytopenias (hypersplenism) in patients with nonalcoholic chronic liver disease. Am J Gastroenterol 95(10):2936–2939PubMedCrossRef
27.
Lechner K, Niessner H, Thaler E (1977) Coagulation abnormalities in liver disease. Semin Thromb Hemost 4(1):40–56PubMed
28.
Green G, Poller L, Thomson JM, Dymock IW (1976) Factor VII as a marker of hepatocellular synthetic function in liver disease. J Clin Pathol 29(11):971–975PubMedCentralPubMedCrossRef
29.
30.
Friedman LS (1999) The risk of surgery in patients with liver disease. Hepatology 29(6):1617–1623PubMedCrossRef
31.
Michalis LK, Rees MR, Patsouras D et al (2002) A prospective randomized trial comparing the safety and efficacy of three commercially available closure devices (Angioseal, Vasoseal and Duett). Cardiovasc Intervent Radiol 25(5):423–429PubMedCrossRef
32.
Ansel G, Yakubov S, Neilsen C et al (2006) Safety and efficacy of staple-mediated femoral arteriotomy closure: results from a randomized multicenter study. Catheter Cardiovasc Interv 67(4):546–553PubMed
33.
Nader RG, Garcia JC, Drushal K, Pesek T (2002) Clinical evaluation of SyvekPatch in patients undergoing interventional, EPS and diagnostic cardiac catheterization procedures. J Invasive Cardiol 14(6):305–307PubMed
34.
Palmer BL, Gantt DS, Lawrence ME, Rajab MH, Dehmer GJ (2004) Effectiveness and safety of manual hemostasis facilitated by the SyvekPatch with one hour of bedrest after coronary angiography using six-French catheters. Am J Cardiol 93(1):96–97PubMedCrossRef
35.
36.
Koreny M, Riedmuller E, Nikfardjam M, Siostrzonek P, Mullner M (2004) Arterial puncture closing devices compared with standard manual compression after cardiac catheterization: systematic review and meta-analysis. JAMA 291(3):350–357PubMedCrossRef
37.
Nikolsky E, Mehran R, Halkin A et al (2004) Vascular complications associated with arteriotomy closure devices in patients undergoing percutaneous coronary procedures: a meta-analysis. J Am Coll Cardiol 44(6):1200–1209PubMed
38.
Dangas G, Mehran R, Kokolis S et al (2001) Vascular complications after percutaneous coronary interventions following hemostasis with manual compression versus arteriotomy closure devices. J Am Coll Cardiol 38(3):638–641PubMedCrossRef
39.
Sohail MR, Khan AH, Holmes DR Jr, Wilson WR, Steckelberg JM, Baddour LM (2005) Infectious complications of percutaneous vascular closure devices. Mayo Clin Proc 80(8):1011–1015PubMedCrossRef
40.
Wang DS, Chu LF, Olson SE et al (2008) Comparative evaluation of noninvasive compression adjuncts for hemostasis in percutaneous arterial, venous, and arteriovenous dialysis access procedures. J Vasc Interv Radiol 19(1):72–79PubMedCrossRef
41.
McTaggart RA, Raghavan D, Haas RA et al (2010) StarClose Vascular closure device: safety and efficacy of deployment and reaccess in a neurointerventional radiology service. Am J Neuroradiol 31:1148–1150PubMedCrossRef
42.
Gray BH, Miller R, Langan EM et al (2009) The utility of the StarClose arterial closure device in patients with peripheral arterial disease. Ann Vasc Surg 23:341–344PubMedCrossRef
43.
Li X, Wang Z, Chen J et al (2013) Safety and effectiveness of repeat arterial closure using the StarClose vascular closure device in patients with hepatic malignancy. Clin Radiol S0009–9260(13):00153
44.
Kirchhof C, Schickel S, Schmidt-Lucke C, Schmidt-Lucke JA (2002) Local vascular complications after use of the hemostatic puncture closure device Angio-Seal. Vasa 31(2):101–106PubMedCrossRef
45.
Wille J, Vos JA, Overtoom TT, Suttorp MJ, van de Pavoordt ED, de Vries JP (2006) Acute leg ischemia: the dark side of a percutaneous femoral artery closure device. Ann Vasc Surg 20(2):278–281PubMedCrossRef
46.
Durack JC, Thor Johnson D, Fidelman N, Kerlan RK, LaBerge JM (2012) Entrapment of the StarClose vascular closure system after attempted common femoral artery deployment. Cardiovasc Intervent Radiol 35(4):942–944PubMedCrossRef
47.
Gonsalves M, Walkden M, Belli AM (2008) Laceration of the common femoral artery following deployment of the Starclose vascular closure system. Cardiovasc Intervent Radiol 31(4):817–820PubMedCrossRef
48.
Castelli P, Caronno R, Piffaretti G, Tozzi M, Lomazzi C (2006) Incidence of vascular injuries after use of the Angio-Seal closure device following endovascular procedures in a single center. World J Surg 30(3):280–284PubMedCrossRef
49.
Mukhopadhyay K, Puckett MA, Roobottom CA (2005) Efficacy and complications of Angioseal in antegrade puncture. Eur J Radiol 56(3):409–412PubMedCrossRef
Metadata
Title
Safety and Efficacy of a Circumferential Clip-Based Vascular Closure Device in Cirrhotic and Coagulopathic Patients with Hepatocellular Carcinoma After Doxorubicin Drug-eluting Beads Transarterial Chemoembolization
Authors
Hasmukh J. Prajapati
Shoaib Rafi
Faramarz Edalat
David A. Kooby
Hyun S. Kim
Publication date
01-06-2014
Publisher
Springer US
Published in
CardioVascular and Interventional Radiology / Issue 3/2014
Print ISSN: 0174-1551
Electronic ISSN: 1432-086X
DOI
https://doi.org/10.1007/s00270-013-0709-9

Other articles of this Issue 3/2014

CardioVascular and Interventional Radiology 3/2014 Go to the issue

Laboratory Investigation

Evaluation of Delcath Systems’ Generation 2 (GEN 2) Melphalan Hemofiltration System in a Porcine Model of Percutaneous Hepatic Perfusion

Laboratory Investigation

Bipolar Radiofrequency Ablation: Development of a New Expandable Device

Clinical Investigation

Outcome Study of Real-time MR-guided Cervical Periradicular Injection Therapy in an Open 1.0 Tesla MRI System

Case Report

Anomalous Unilateral Single Pulmonary Vein Mimicking Pulmonary Arteriovenous Malformation

Clinical Investigation

Endovascular Salvage of Immature Autogenous Hemodialysis Fistulas

Clinical Investigation

A Scoring-System for Angiographic Findings in Nonocclusive Mesenteric Ischemia (NOMI): Correlation with Clinical Risk Factors and its Predictive Value