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Post-Catheterization Vascular Hemostasis
"Vascular Complications After Percutaneous Coronary Interventions Following Hemostasis With
Manual Compression Versus Arteriotomy Closure Devices"; In this study conducted at the Washington Hospital Center, 5,098 consecutive patients undergoing percutaneous coronary intervention (PCI) were evaluated to determine vascular complication rates with arteriotomy closure devices (ACD) versus manual compression. Use of ACD or manual compression was based on the operator's preference. Complication rates were found to be significantly higher for several types of complications when ACDs were used: hematoma incidence was 9.3% with ACD versus 5.1% for manual compression; incidence of a hematocrit drop of >15% was 5.2% versus 2.5% for manual compression; incidence of vascular surgical repair at the access site was 2.5% versus 1.5% for manual compression. The study concludes: "In this early experience with ACD after PCI, their [ACD's] use was associated with higher vascular complication rates than hemostasis with manual compression."
"Commentary - Angio-Seal Use in Overweight Patients:
Is Angio-Seal Use Safe in Overweight Patients or is it Unsafe in Lower-Weight Patients?"; In this Commentary, which appeared in the September, 2001 issue of the Journal of Invasive Cardiology, the authors reviewed the literature to evaluate safety of using Angio-Seal in overweight patients, compared to patients having a normal or lower-than-normal weight. The study states that "Angio-Seal appears safe in overweight patients. However, complication rates of Angio-Seal in normal or lower weight patients remain to be established." The authors cite a study by Warren et al (Warren BS, Warren SG, Miller SD; Catheterization and Cardiovascular Interventions, 1999; 48: 162-166) in which it was found that using Angio-Seal in patients having a body mass index (BMI) of <28kg/m2 was associated with a substantially higher risk of complications, as was use of heparin and 8Fr catheters. The study also finds that "in coronary intervention, the sealing devices offer no advantage of early discharge".
"Safety of Suture-Mediated Closure Devices"; The study "Safety of Suture-Mediated Closure Devices" by Kahn, Kumar, Hollander and Frankel was published in Catheterization and Cardiovascular Interventions in January, 2002. The authors compared major and minor complication rates in patients on whom either Perclose or manual compression was used. This retrospective study, conducted at Maimonides Medical Center between 1997 and 1999, included 8,906 diagnostic and 1,095 interventional catheterization patients. Sheath sizes ranged from 5 Fr to 8 Fr. Patients receiving manual compression were ambulated between 4-6 hours following sheath removal; patients receiving Perclose were ambulated at 4 hours following sheath removal. Perclose patients experienced dramatically higher complication rates than manual compression patients for diagnostic angiography: 2.6% and 4.6% rates for Perclose major and minor complications, respectively, compared to 0.2% and 1.8% for manual compression major and minor complications, respectively. Complication rates for interventional patients were similar between the Perclose and manual compression groups. Perclose deployment success rates were 94% for diagnostic and 90% for interventional catheterizations; re-sterilization preceded Perclose deployment. The study abstract states: "A significantly higher complication rate was noted for both major and minor complications in the diagnostic catheterization patients treated with the Prostar-Plus device compared to diagnostic patients treated with manual compression."
"Efficacy of Invasive Vascular Closure Devices for Femoral Hemostasis - Reader's Comment"; This Reader's Comment addressed the article by Cura et al which appeared in the October 1, 2000 issue of the American Journal of Cardiology. The Comment highlighted three of the Cura article's findings regarding interventional patients on whom invasive closure devices were deployed: 1) significantly elevated risk of retroperitoneal hemorrhage, compared to manual compression; 2) overall rate of complications was not less than the rate for manual compression; 3) ambulation occurred over four hours after the intervention. Koch and colleagues reported a post-procedure bedrest period of <3 hours for interventional patients using manual compression (Heart, 1999; 81:53-56), with a low rate of minor puncture site complications and no major complications. It's suggested that: "manual and mechanical compression hemostasis methods result in overall clinical and time-to-ambulation outcomes are similar to those achieved with the more expensive, and in some instances, riskier invasive closure devices. Mechanical compression methods also have the benefit of lower cost."
"Femoral Hemostasis - Correspondence"; This Correspondence by Semler appeared in the Volume 28, Number 1 issue of the Texas Heart Institute Journal and addresses the article by Krajcer and Howell which appeared in the previous issue. The Correspondence highlights other closure device studies demonstrating higher incidence of severe complications and infections compared to manual or mechanical compression. Semler also discusses the higher cost of closure devices and references articles demonstrating early ambulation without use of closure devices. The Correspondence concludes: "Given the higher risks and costs associated with invasive closure devices, their use should be critically evaluated against the use of proven, lower-cost methods of achieving femoral hemostasis."
"Femoral Hemostasis - Correspondence Reply"; This reply by Krajcer and Howell to the Correspondence by Semler appeared in the Volume 28, Number 1 issue of the Texas Heart Institute Journal. The authors state that "there is no evidence in the literature of a significant financial or other benefit achieved by using these [closure] devices in patients undergoing routine diagnostic procedures". The authors conclude: "the use of these [closure] devices for routine peripheral and coronary intervention is of debatable importance."
"Complications Related to the Use of Vascular Hemostasis Devices"; This letter highlighted certain observed complications occurring with invasive vascular closure devices and made recommendations regarding their use, as follows: |
