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Post-Catheterization Vascular Hemostasis
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"Infectious Complications of Percutaneous Vascular Closure Device (PVCD)"
- Sohail, et al
Mayo Clinic Proceedings 2005;80(8):1011-1015
This study retrospectively reviewed cases of PVCD-related infection from experience at the Mayo Clinic and from the medical literature, with 52 cases identified as having access-site infection and a total of 90 cases as having PVCD-related infection (including infection at the access site). Median time to presentation from PVCD insertion was 8 days. Symptoms including pain, erythema, swelling, drainage and fever were common at presentation. Present in 42% of cases, mycotic pseudoaneurysm (MPA) was the most commonly reported complication, requiring medical (antibiotic) and surgical intervention in 100% of cases. S Aureus, and staphylococcus were the most commonly reported organisms. Reconstructive procedures were required in 54% of cases. The mortality rate was 6%, with all deaths resulting from severe sepsis. PVCD-related infectious complication rates of up to 5.1% are reported in the literature, compared with external compression where "infection has been reported rarely". Overall complication rates for PVCD patients were found to be generally similar to patients on whom external compression was used but infections were significantly more common in the PVCD population, and typically present with much higher acuity. Although relatively uncommon, PVCD-related infection is an emerging and serious phenomenon with high morbidity, and requires aggressive medical and surgical intervention to achieve cure.
"Complications of a Percutaneous Suture-mediated Closure Device versus Manual Compression for Arteriotomy Closure: A Case-controlled Study"
- Wagner, et al
Journal of Vascular Interventional Radiology 2003; 14:735-741
In this retrospective case-controlled study of 100 consecutive patients, the authors report a 7% overall complication rate with the Perclose Closer device, a rate higher than the 1% complication rate for external compression. The Perclose-related major complication rate of 3% was also higher than the 1.3% rate associated with external compression. An unexpectedly high frequency of major complications was found in a sub-population of young, otherwise healthy women undergoing uterine artery embolization (UAE), where 4 of 65 patients were affected, including one who required prolonged hospitalization with surgical intervention and permanent sequelae. All complications involved "cases of persistent bleeding". Notably, no complications were reported for UAE patients on whom external compression was used. The authors conclude that "significantly more complications were associated with use of a percutaneous suture-mediated closure device than with manual compression".
"Cardiac Catheter Device May Raise Complications"
- Matthews, AW
The Wall Street Journal, March 8, 2005; P. D-5
The results of an FDA-funded study were presented in a poster at the 2005 ACC conference, which showed that patients with "VasoSeal having 2.38 times more likely to have vascular complications than people whose doctors performed manual compression", or a rate of 623 vascular complications per 10,000 uses. Women were found to be more likely to have complications than men. All data was obtained from the ACC registry.
"Commentary - Current Status of Suture-mediated Closure: What is the Cost of Comfort?"
- Brown, DB
Journal of Vascular Interventional Radiology 2003; 14:677-681
This commentary assesses the risks and costs of the use of suture-mediated closure devices against their claimed benefits. The author cites a variety of complications related to the use of the Perclose vascular closure devices and raises questions about routine use of these devices for post-catheterization femoral hemostasis without specific clinical need, given the lengthy learning curves and device failure rates of 4%-11%. Suture-mediated closure complications are also frequently more severe than complications associated with manual compression: "when complications occur, they are potentially more devastating and appear to be more morbid than those after manual compression". The author concludes that although some patients may derive benefit from use of such closure devices, their "routine use after diagnostic angiography can not be endorsed at this time".
"Granuloma Formation around a Retained Perclose S Suture Presenting 12 Months after Implantation"
- Doshi, et al
Journal of Vascular Interventional Radiology, 2004; 15:759-761
This case study examined a sterile granuloma formation around an untrimmed Perclose S suture at presentation 12 months following completion of a coronary angiography procedure. The patient had observed an intermittent discharge at the access site and was referred to a vascular surgeon, who observed a 3-cm length of suture protruding from the skin. Surgical exploration revealed the suture to be circumferentially encased in thick granulomatous tissue in continuity with the femoral artery. Following excision of the granuloma, suture and a portion of the femoral arterial wall, the after which the femoral artery was repaired. Careful technique is required to avoid complications, specifically with Perclose devices, to ensure that the suture is always trimmed as short as possible. The article described a Perclose device failure rate of 6.1% with a 3% rate of major complications.
"Safety of Femoral Closure Devices after Percutaneous Coronary Interventions in the era of Glycoprotein IIb/IIIa Platelet Blockade"
- Cura, et al
American Journal of Cardiology, , October 1, 2000; vol. 86, pp.780-782
The article by Cura, et al, entitled "Safety of Femoral Closure Devices after Percutaneous Coronary Interventions in the era of Glycoprotein IIb/IIIa Platelet Blockade", appeared in the October 1, 2000 issue of the American Journal of Cardiology (vol. 86, pp.780-782). The study, from The Cleveland Clinic, notes that all operators were trained in the use of the closure devices in advance of the study period. A total of 2,918 patients were included in the study, of whom 2,099 were manually compressed, 411 received Angio-Seal, and 408 received Perclose.
Overall complication rates were "similar among the 3 treatment groups" (manual compression, Angio-Seal, Perclose), regardless of whether IIb/IIIa blockade was used. Rates were: 3.1% for manual compression, 2.9% for Angio-Seal, and 3.2% for Perclose.
However, the rate of severe complications was higher in the closure device groups:
- Retroperitoneal hemorrhage rate was 10X higher in the Angio-Seal group than in the manual compression group; the rate was 8X higher in the Perclose group.
- Rate of access-site-related blood transfusion was 50% higher in the Angio-Seal group, compared to the manual compression group; the rate was 2.1X higher in the Perclose group.
- Access site infections occurred only with Perclose, where the rate was 0.5%.
- Rate of vascular surgery was 0.4% for manual compression, 0.2% for Angio-Seal, and 1.0% for Perclose, an increase of 2.5x over manual compression.
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"Vascular Complications After Percutaneous Coronary Interventions Following Hemostasis With
Manual Compression Versus Arteriotomy Closure Devices";
-Dangas G, Mehran R, Kokolis S, et al
Journal of the American College of Cardiology, 2001 (38:3; pp.638-641)
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."
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"Commentary - Angio-Seal Use in Overweight Patients:
Is Angio-Seal Use Safe in Overweight Patients or is it Unsafe in Lower-Weight Patients?";
- Denktas A, Holmes D, Schwartz R: Mayo Clinic
Journal of Invasive Cardiology, 2001 (13:9; pp. 626-627)
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".
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"Safety of Suture-Mediated Closure Devices";
-Kahn, Kumar, Hollander, Frankel
Catheterization and Cardiovascular Interventions, 2002 (55:8-13)
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."
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"Efficacy of Invasive Vascular Closure Devices for Femoral Hemostasis - Reader's Comment";
- Semler
American Journal of Cardiology, 2001 (87:504)
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."
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"Femoral Hemostasis - Correspondence";
-Semler
Texas Heart Institute Journal, 2001 (28,1:76)
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."
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"Femoral Hemostasis - Correspondence Reply";
-Krajcer and Howell
Texas Heart Institute Journal, 2001 (28,1:77)
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."
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"Complications Related to the Use of Vascular Hemostasis Devices";
- Letter published by FDA Center for Devices and Radiological Health; October, 1999.
This letter highlighted certain observed complications occurring with invasive vascular closure devices and made recommendations regarding their use, as follows:
"- Do not use vascular hemostasis devices to treat patients with suspected double wall punctures, as punctures of the posterior wall are not closed with these devices.
- Carefully weigh the risk of bleeding at the puncture site against the benefits of using a vascular hemostasis device when treating patients with bleeding disorders or patients medicated with platelet glycoprotein IIb/IIIa receptor inhibitors.
- Carefully monitor the groin puncture site to minimize the occurrence of complications with vascular hemostasis devices.
- Special attention should be paid to any post-procedure patient-management instructions or ambulation recommendations for the specific vascular hemostasis device used."
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