INTERVENTIONAL CARDIOLOGY
Vascular complications associated with arteriotomy closure devices in patients undergoing percutaneous coronary procedures
A meta-analysis
Eugenia Nikolsky, MD, PhD*,
Roxana Mehran, MD, FACC*,
Amir Halkin, MD*,
Eve D. Aymong, MD, FACC*,
Gary S. Mintz, MD, FACC*,
Zoran Lasic, MD, FACC*,
Manuela Negoita, MD*,
Martin Fahy, MSc*,
Shoshana Krieger, BA*,
Issam Moussa, MD, FACC*,
Jeffrey W. Moses, MD, FACC*,
Gregg W. Stone, MD, FACC*,
Martin B. Leon, MD, FACC*,
Stuart J. Pocock, PhD and
George Dangas, MD, PhD, FACC*,*
* Cardiovascular Research Foundation and the Lenox Hill Heart and Vascular Institute, New York, New York, USA
London School of Hygiene and Tropical Medicine, London, United Kingdom
Manuscript received February 18, 2004;
revised manuscript received June 1, 2004,
accepted June 9, 2004.
* Reprint requests and correspondence: Dr. George Dangas, Cardiovascular Research Foundation, 55 East 59th Street, 6th Floor, New York, New York 10022 (Email: gdangas{at}crf.org).
OBJECTIVES: This study was designed to assess the safety of arteriotomy closure devices (ACDs) versus mechanical compression by meta-analysis in patients undergoing percutaneous transfemoral coronary procedures.
BACKGROUND: Although ACDs are widely applied for hemostasis after percutaneous endovascular procedures, their safety is controversial.
METHODS: Randomized, case-control, and cohort studies comparing access-related complications using ACDs versus mechanical compression were analyzed. The primary end point was the cumulative incidence of vascular complications, including pseudoaneurysm, arteriovenous fistula, retroperitoneal hematoma, femoral artery thrombosis, surgical vascular repair, access site infection, and blood transfusion.
RESULTS: A total of 30 studies involving 37,066 patients were identified. No difference in complication incidence between Angio-Seal and mechanical compression was revealed in the diagnostic (Dx) setting (odds ratio [OR] 1.08, 95% confidence interval [CI] 0.11 to 10.0) or percutaneous coronary interventions (PCI) (OR 0.86, 95% CI 0.65 to 1.12). Meta-analysis of randomized trials only showed a trend toward less complications using Angio-Seal in a PCI setting (OR 0.46, 95% CI 0.20 to 1.04; p = 0.062). No differences were observed regarding Perclose in either Dx (OR 1.51, 95% CI 0.24 to 9.47) or PCI (OR 1.21, 95% CI 0.94 to 1.54) setting. An increased risk in complication rates using VasoSeal in the PCI setting (OR 2.25, 95% CI 1.07 to 4.71) was found. The overall analysis favored mechanical compression over ACD (OR 1.34, 95% CI 1.01 to 1.79).
CONCLUSIONS: In the setting of Dx angiography, the risk of access-site-related complications was similar for ACD compared with mechanical compression. In the setting of PCI, the rate of complications appeared higher with VasoSeal.
|
Abbreviations and Acronyms
| | ACD = arteriotomy closure devices | | CI = confidence interval | | Dx = diagnostic | | OR = odds ratio | | PCI = percutaneous coronary intervention | | RCT = randomized controlled trial |
|
This article has been cited by other articles:
|
|
|
|
 
B. Ahmed, W. D. Piper, D. Malenka, P. VerLee, J. Robb, T. Ryan, M. Herne, W. Phillips, and H. L. Dauerman
Significantly Improved Vascular Complications Among Women Undergoing Percutaneous Coronary Intervention: A Report From the Northern New England Percutaneous Coronary Intervention Registry
Circ Cardiovasc Interv,
October 1, 2009;
2(5):
423 - 429.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
S. C. Wong, W. Bachinsky, P. Cambier, R. Stoler, J. Aji, J. H. Rogers, J. Hermiller, R. Nair, H. Hutman, H. Wang, et al.
A Randomized Comparison of a Novel Bioabsorbable Vascular Closure Device Versus Manual Compression in the Achievement of Hemostasis After Percutaneous Femoral Procedures: The ECLIPSE (Ensure's Vascular Closure Device Speeds Hemostasis Trial)
J. Am. Coll. Cardiol. Intv.,
August 1, 2009;
2(8):
785 - 793.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
B. J. Doyle, C. S. Rihal, D. A. Gastineau, and D. R. Holmes Jr
Bleeding, blood transfusion, and increased mortality after percutaneous coronary intervention implications for contemporary practice.
J. Am. Coll. Cardiol.,
June 2, 2009;
53(22):
2019 - 2027.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
M. Hamon and J. Nolan
Should radial artery access be the "gold standard" for PCI?
Heart,
December 1, 2008;
94(12):
1530 - 1532.
[Full Text]
[PDF]
|
|
|
|
|
|
|
B. Shoulders-Odom
Management of Patients After Percutaneous Coronary Interventions
Crit. Care Nurse,
October 1, 2008;
28(5):
26 - 40.
[Full Text]
[PDF]
|
|
|
|
|
|
|
A J Chase, E B Fretz, W P Warburton, W P Klinke, R G Carere, D Pi, B Berry, and J D Hilton
Association of the arterial access site at angioplasty with transfusion and mortality: the M.O.R.T.A.L study (Mortality benefit Of Reduced Transfusion after percutaneous coronary intervention via the Arm or Leg)
Heart,
August 1, 2008;
94(8):
1019 - 1025.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
R. J. Applegate, M. T. Sacrinty, M. A. Kutcher, F. R. Kahl, S. K. Gandhi, R. M. Santos, and W. C. Little
Trends in Vascular Complications After Diagnostic Cardiac Catheterization and Percutaneous Coronary Intervention Via the Femoral Artery, 1998 to 2007
J. Am. Coll. Cardiol. Intv.,
June 1, 2008;
1(3):
317 - 326.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
I. Malik
Closure devices for femoral punctures
Heart,
May 1, 2008;
94(5):
547 - 548.
[Full Text]
[PDF]
|
|
|
|
|
|
|
J. M. Wilson and J. T. Willerson
Myocardial Revascularization with Percutaneous Devices
Card. Surg. Adult,
January 1, 2008;
3(2008):
573 - 598.
[Full Text]
|
|
|
|
|
|
|
H. L. Dauerman, R. J. Applegate, and D. J. Cohen
Vascular Closure Devices: The Second Decade
J. Am. Coll. Cardiol.,
October 23, 2007;
50(17):
1617 - 1626.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
J. P. C. Lin, B. G. Rubin, and W. D. Middleton
Vascular Injury From an Arterial Closure Device
J. Ultrasound Med.,
October 1, 2007;
26(10):
1441 - 1444.
[Full Text]
[PDF]
|
|
|
|
|
|
|
E. Calderon, E. Carter, K. M. Ramsey, J. A. Vande Waa, W. K. Green, and M. A. Alpert
Necrotizing Fasciitis: A Complication of Percutaneous Coronary Revascularization
Angiology,
June 1, 2007;
58(3):
360 - 366.
[Abstract]
[PDF]
|
|
|
|
|
|
|
G. W. Webber, J. Jang, S. Gustavson, and J. W. Olin
Contemporary Management of Postcatheterization Pseudoaneurysms
Circulation,
May 22, 2007;
115(20):
2666 - 2674.
[Full Text]
[PDF]
|
|
|
|
|
|
|
The Society of Thoracic Surgeons Blood Conservatio, V. A. Ferraris, S. P. Ferraris, S. P. Saha, E. A. Hessel II, C. K. Haan, B. D. Royston, C. R. Bridges, R. S.D. Higgins, G. Despotis, et al.
Perioperative Blood Transfusion and Blood Conservation in Cardiac Surgery: The Society of Thoracic Surgeons and The Society of Cardiovascular Anesthesiologists Clinical Practice Guideline
Ann. Thorac. Surg.,
May 1, 2007;
83(5_Supplement):
S27 - S86.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
F. S. Resnic
The Case for Outpatient Coronary Intervention: Balancing Charges and Discharges
Circulation,
May 1, 2007;
115(17):
2248 - 2250.
[Full Text]
[PDF]
|
|
|
|
|
|
|
G. S. Heyde, K. T. Koch, R. J. de Winter, M. G.W. Dijkgraaf, M. I. Klees, L. M. Dijksman, J. J. Piek, and J. G.P. Tijssen
Randomized Trial Comparing Same-Day Discharge With Overnight Hospital Stay After Percutaneous Coronary Intervention: Results of the Elective PCI in Outpatient Study (EPOS)
Circulation,
May 1, 2007;
115(17):
2299 - 2306.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
C. Derham, J. F. Davies, R. Shahbazi, and S. Homer-Vanniasinkam
Iatrogenic Limb Ischemia Caused by Angiography Closure Devices
Vascular and Endovascular Surgery,
January 1, 2007;
40(6):
492 - 494.
[Abstract]
[PDF]
|
|
|
|
|
|
|
S. Lins, D. Guffey, S. VanRiper, and E. Kline-Rogers
Decreasing vascular complications after percutaneous coronary interventions: partnering to improve outcomes.
Crit. Care Nurse,
December 1, 2006;
26(6):
38 - 45.
[Full Text]
[PDF]
|
|
|
|
|
|
|
B. J. Doyle, B. A. Konz, R. J. Lennon, J. F. Bresnahan, C. S. Rihal, and H. H. Ting
Ambulation 1 Hour After Diagnostic Cardiac Catheterization: A Prospective Study of 1009 Procedures
Mayo Clin. Proc.,
December 1, 2006;
81(12):
1537 - 1540.
[Abstract]
[Full Text]
[PDF]
|
|
|
|
|
|
|
M. H. Lunden, A. Bengtson, and S. M. Lundgren
Hours During and After Coronary Intervention and Angiography
Clin Nurs Res,
November 1, 2006;
15(4):
274 - 289.
[Abstract]
[PDF]
|
|
|
|
|
|
|
G. D. Dangas
Reply
J. Am. Coll. Cardiol.,
June 21, 2005;
45(12):
2096 - 2096.
[Full Text]
[PDF]
|
|
|
|
|
|
|
T. M. Chou
Vascular Complications and Arteriotomy Closure Devices During Percutaneous Coronary Procedures
J. Am. Coll. Cardiol.,
June 21, 2005;
45(12):
2095 - 2096.
[Full Text]
[PDF]
|
|
|
|
