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

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

Research output: Contribution to journalArticle

5 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)664-670
Number of pages7
JournalCardiovascular and Interventional Radiology
Volume37
Issue number3
DOIs
StatePublished - Jan 1 2014

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Surgical Instruments
Doxorubicin
Hepatocellular Carcinoma
Platelet Count
Safety
Pharmaceutical Preparations
Hemostasis
Equipment and Supplies
International Normalized Ratio
Groin
False Aneurysm
Thigh
Vascular Closure Devices
Punctures
Hematoma
Leg
Body Mass Index
Ischemia
Infection

All Science Journal Classification (ASJC) codes

  • Radiology Nuclear Medicine and imaging
  • Cardiology and Cardiovascular Medicine

Cite this

@article{2d12a27a9bfe492f91d8d0625b19a12e,
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",
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.",
author = "Hasmukh Prajapati and Shoaib Rafi and Faramarz Edalat and Kooby, {David A.} and Kim, {Hyun S.}",
year = "2014",
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T1 - 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

AU - Prajapati, Hasmukh

AU - Rafi, Shoaib

AU - Edalat, Faramarz

AU - Kooby, David A.

AU - Kim, Hyun S.

PY - 2014/1/1

Y1 - 2014/1/1

N2 - 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.

AB - 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.

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U2 - 10.1007/s00270-013-0709-9

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