21 results on '"Hemostatic Techniques instrumentation"'
Search Results
2. Novel vascular sealing device for closure of percutaneous vascular access sites.
- Author
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Gershony G, Brock JM, and Powell JS
- Subjects
- Animals, Collagen administration & dosage, Dogs, Equipment Design, Femoral Artery pathology, Humans, Thrombin administration & dosage, Wound Healing physiology, Catheterization instrumentation, Catheters, Indwelling, Hemostatic Techniques instrumentation
- Abstract
To investigate the hemostatic capabilities of a novel vascular sealing device consisting of a balloon catheter and procoagulant, vascular sheaths were placed percutaneously in the femoral arteries of dogs. The sealing device was evaluated using the balloon catheter alone in six femoral arteries and with the addition of a procoagulant, in 21 femoral arteries. The balloon catheter alone was successfully deployed in six of six femoral arteries achieving immediate hemostasis. In a second study in which the procoagulant was delivered following balloon placement, the sealing device was successfully deployed and hemostasis was achieved in 20 of 21 attempts (95%) despite removal of the balloon catheter. In a subset of fully anticoagulated animals, hemostasis was achieved in the sealing device-treated arteries at 6.5+/-3.4 minutes, but in none of the controls (P < 0.001). This novel vascular sealing device successfully achieves rapid hemostasis in normal and anticoagulated dogs following percutaneous vascular procedures.
- Published
- 1998
- Full Text
- View/download PDF
3. Re Carere et al.
- Author
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Ford JK
- Subjects
- Anticoagulants therapeutic use, Humans, Collagen, Femoral Artery surgery, Hemostatic Techniques adverse effects, Hemostatic Techniques instrumentation, Punctures
- Published
- 1998
- Full Text
- View/download PDF
4. Re Carere et al.
- Author
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McKeever LS
- Subjects
- Humans, Collagen, Hemostatic Techniques adverse effects, Hemostatic Techniques instrumentation
- Published
- 1998
- Full Text
- View/download PDF
5. Re Carere et al.
- Author
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Moore JA
- Subjects
- Humans, Collagen, Hemostatic Techniques adverse effects, Hemostatic Techniques instrumentation
- Published
- 1998
6. 6F TECHSTAR application as a bailout for partially deployed 8F PROSTAR.
- Author
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Meisel SR, Shani J, and Frankel RA
- Subjects
- Aged, Equipment Failure, Female, Humans, Sutures, Angioplasty, Balloon, Coronary instrumentation, Cardiac Catheterization instrumentation, Hemostatic Techniques instrumentation
- Published
- 1998
- Full Text
- View/download PDF
7. Femoral puncture site closure devices: the easy way out?
- Author
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Chatterjee T and Meier B
- Subjects
- Catheterization, Peripheral adverse effects, Collagen administration & dosage, Hemostatic Techniques adverse effects, Humans, Femoral Artery, Hemostatic Techniques instrumentation, Punctures
- Published
- 1998
- Full Text
- View/download PDF
8. Groin complications with collagen plug closure of femoral arterial puncture site.
- Author
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Myler RK
- Subjects
- Catheterization, Peripheral adverse effects, Groin blood supply, Hemostatic Techniques adverse effects, Humans, Collagen administration & dosage, Femoral Artery, Hemostatic Techniques instrumentation, Punctures
- Published
- 1998
- Full Text
- View/download PDF
9. Groin complications associated with collagen plug closure of femoral arterial puncture sites in anticoagulated patients.
- Author
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Carere RG, Webb JG, Miyagishima R, Djurdev O, Ahmed T, and Dodek A
- Subjects
- Aged, Angioplasty, Balloon, Coronary adverse effects, Coronary Angiography, Female, Groin blood supply, Hematoma etiology, Hemorrhage chemically induced, Hemorrhage etiology, Hemorrhage therapy, Hemostatic Techniques instrumentation, Humans, Male, Middle Aged, Multivariate Analysis, Retrospective Studies, Risk Factors, Vascular Surgical Procedures, Anticoagulants therapeutic use, Catheterization, Peripheral adverse effects, Collagen administration & dosage, Femoral Artery, Hemostatic Techniques adverse effects, Punctures adverse effects
- Abstract
A retrospective study was conducted to determine the frequency and nature of groin complications when the Vasoseal (Datascope Corp., NJ) hemostasis device was used on 204 occasions to enable removal of the groin sheath in anticoagulated patients. The patients had undergone balloon angioplasty (53%), coronary stenting (20%), and diagnostic angiography (27%). Complications included vascular surgery in 5% including 2 embolized collagen plugs, failure to achieve hemostasis (2%), late external bleeding (2%), purulent discharge (1.5%), a minor ooze of blood (7%), hematomas >6 cm (6%), and hematomas < or = 6 cm (7%). One or more complications occurred with 64 of 204 (30.5%) uses. Multivariate analysis identified diagnostic angiography to be associated with a reduced risk of complications [odds ratio (OR) 0.25], while stent procedure (OR 2.7) and female gender (OR 2.5) were associated with increased risk. This complication rate is similar to other reported series except for a higher rate of vascular surgery. The high incidence of anticoagulation in our study patients (94%) may explain this difference. We recommend caution and adherence to the recommended technique when the device is used in anticoagulated patients.
- Published
- 1998
- Full Text
- View/download PDF
10. New device for compression of the radial artery after diagnostic and interventional cardiac procedures.
- Author
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Chatelain P, Arceo A, Rombaut E, Verin V, and Urban P
- Subjects
- Aged, Angioplasty methods, Angioplasty, Balloon, Coronary adverse effects, Angioplasty, Balloon, Coronary methods, Chi-Square Distribution, Coronary Angiography adverse effects, Coronary Angiography methods, Equipment Design, Female, Hematoma etiology, Hemorrhage etiology, Hemostatic Techniques adverse effects, Humans, Male, Middle Aged, Punctures adverse effects, Vascular Patency, Hemostatic Techniques instrumentation, Pressure, Radial Artery physiopathology
- Abstract
Recently the transradial route has emerged as a valuable alternative to the femoral approach for coronary angiography and angioplasty. However, sheath and catheter size and their immediate removal after the procedure, combined with aggressive antiplatelet and anticoagulant therapies, have favored mechanical compression of the radial artery to achieve satisfactory hemostasis. We report on our initial clinical experience with a new device specially designed for prolonged controlled mechanical compression of the radial artery (the RadiStop radial compression system, RADI Medical Systems AB, Uppsala, Sweden). A total of 159 consecutive patients (mean age 60 +/- 11 yr, 130 males) who required either coronary angiography (group 1, 103 patients) or ad hoc or elective coronary angioplasty (group 2, 56 patients) via the right radial route had local hemostasis with the RadiStop system. In group 1, 4F and 5F sheaths and catheters were used, whereas in group 2, 6F systems were inserted in the radial artery. Hemostasis was achieved with the device in all patients but was considered difficult to obtain in 4 patients (2.5%). Twenty-eight patients (18%) considered the device uncomfortable or painful, but no release of pressure was necessary. The mean compression time was 151 +/- 82 min (114 +/- 64 min in group 1, and 223 +/- 64 min in group 2; P = 0.0001). There were 23 local complications (15%). In 7 patients (4.4%), the radial pulse was absent after compression and at discharge, without major clinical consequences. In one patient, recurrent bleeding occurred 2 hr after compression, requiring a new compression session. In 15 patients, a small local hematoma was observed. Neither heparin dosage nor the use of a 6F sheath affected the rate of radial artery patency in this survey. We conclude that the use of this device for mechanical compression of the radial artery after coronary angiography and angioplasty is efficient, and that its use is related to an acceptable rate of local complications.
- Published
- 1997
- Full Text
- View/download PDF
11. Mechanical versus manual compression of radial artery following percutaneous transradial approach for coronary arteriography and angioplasty.
- Author
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Cheng TO
- Subjects
- Angioplasty, Balloon, Coronary adverse effects, Coronary Angiography adverse effects, Humans, Punctures adverse effects, Angioplasty, Balloon, Coronary methods, Coronary Angiography methods, Hemostatic Techniques instrumentation, Pressure, Radial Artery physiopathology
- Published
- 1997
- Full Text
- View/download PDF
12. Initial experience using Prostar: a new device for percutaneous suture-mediated closure of arterial puncture sites.
- Author
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Carere RG, Webb JG, Ahmed T, and Dodek AA
- Subjects
- Aged, Atherectomy, Coronary instrumentation, Blood Coagulation Tests, Coronary Angiography instrumentation, Coronary Disease therapy, Equipment Design, Equipment Failure, Female, Femoral Vein, Humans, Intra-Aortic Balloon Pumping instrumentation, Male, Middle Aged, Myocardial Infarction therapy, Prospective Studies, Stents, Treatment Outcome, Angioplasty, Balloon, Coronary instrumentation, Femoral Artery, Hemostatic Techniques instrumentation, Punctures instrumentation, Suture Techniques instrumentation
- Abstract
A new device that enables closure of the femoral artery puncture site by percutaneous placement of two nonabsorbable sutures (Prostar) was evaluated. Our initial experience included 32 insertion attempts at 29 femoral arterial puncture sites and one femoral venous puncture site. The device was applied at arterial puncture sites that had been used to carry out 12 balloon angioplasties (41%), seven intracoronary stent placements (24%), five intraaortic balloon pump insertions (17%), four diagnostic angiographies (14%), and one rotational ablation (3%). The venous access site closed was in a patient who had undergone balloon angioplasty and intracoronary thrombolysis. Most patients were anticoagulated with an average activated clotting time (ACT) of 306 +/- 123 sec (12 patients) or an average PTT of 68 +/- 29 sec (14 patients). There were four failures to achieve hemostasis using the device due to: inability to place the device because of peripheral vascular disease, entrapment of cutaneous tissue in the suture, a suture break that prevented hemostasis from being achieved, and avulsion of the sutures from the needles. Although three other suture breaks occurred, these did not prevent hemostasis from being achieved. Thus, 88% (28/32) of attempted uses were successful, and by using a second device in two of the failed attempts, 94% (30/32) of the puncture sites were successfully closed using the device. There was one late rebleed that required 1 hr of groin clamp pressure in an angioplasty patient who had received intracoronary urokinase. An ooze of blood occurred in 4 patients, but in only 2 was this more than trivial, resulting in discontinuation of heparin in one patient and a small hematoma in the other. We conclude that this device can be used safely and effectively, even in fully anticoagulated patients who have undergone complex procedures. The ultimate role of the device will require further experience and appropriate randomized studies.
- Published
- 1996
- Full Text
- View/download PDF
13. Percutaneous hemostatic closure systems: is the cost worth the price?
- Author
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Satler LF and Mintz G
- Subjects
- Coronary Angiography economics, Coronary Disease diagnostic imaging, Coronary Disease economics, Cost-Benefit Analysis, Early Ambulation economics, Equipment Design, Hemostatic Techniques economics, Humans, Suture Techniques economics, Angioplasty, Balloon, Coronary instrumentation, Coronary Angiography instrumentation, Coronary Disease therapy, Hemostatic Techniques instrumentation, Suture Techniques instrumentation
- Published
- 1996
- Full Text
- View/download PDF
14. Has the time come for the plug?
- Author
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Vainer J and Meier B
- Subjects
- Coronary Disease therapy, Equipment Design, Equipment Failure, Humans, Risk Factors, Angioplasty, Balloon, Coronary instrumentation, Femoral Artery, Hemostatic Techniques instrumentation, Prostheses and Implants
- Published
- 1996
- Full Text
- View/download PDF
15. Femoral artery hemostasis using an implantable device (Angio-Seal) after coronary angioplasty.
- Author
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Kussmaul WG, Buchbinder M, Whitlow PL, Aker UT, Heuser RR, King SB, Kent KM, Leon MB, Kolansky DM, and Sandza JG
- Subjects
- Aged, Equipment Failure, Female, Humans, Male, Middle Aged, Treatment Outcome, Angioplasty, Balloon, Coronary instrumentation, Coronary Disease therapy, Femoral Artery, Hemostatic Techniques instrumentation, Prostheses and Implants
- Abstract
Coronary catheter interventional procedures are associated with risk of access site complications. We report our experience with Angio-Seal, an implantable hemostasis device, when used in the femoral artery after coronary angioplasty procedures. Sixty-eight patients were studied. Their average age was 63 years; 84% of the patients were male. All had 8 French access sheaths and received bolus heparin (mean dose 12,690 U). The arterial sheaths were removed an average of 455 min after the conclusion of the procedure, when the activated clotting time was 220 +/- 94 sec (range 97-503 sec). The hemostasis device was successfully deployed in 63 patients (93%). The average time to achieve complete arterial hemostasis was 4.4 +/- 8.9 min (range 0-45). Immediate, total hemostasis without requiring any form of external pressure was obtained in 37 of these patients (54%). the incidence of complications was as follows: significant bleeding occurred in 9 patients (13%); there were 2 hematomas (3%); there were no vascular or infectious complications. One device embolization occurred when the connecting suture broke and the intravascular anchor was lost; no clinical sequelae resulted, and manual hemostasis was successful. In four other patients, the device did not deploy and was removed entirely, followed by uneventful manual hemostasis. Follow-up for 2 months revealed no late sequelae in any patient, and complete absorption of the device was documented by ultrasound study in all cases. We conclude that this implantable device can achieve arterial hemostasis quickly and safety when used in anticoagulated patients after coronary interventional procedures.
- Published
- 1996
- Full Text
- View/download PDF
16. A single center randomized trial assessing use of a vascular hemostasis device vs. conventional manual compression following PTCA: what are the potential resource savings?
- Author
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Slaughter PM, Chetty R, Flintoft VF, Lewis S, Sykora K, Beattie DM, and Schwartz L
- Subjects
- Adult, Aged, Angioplasty, Balloon, Coronary instrumentation, Collagen administration & dosage, Coronary Disease economics, Cost Savings, Female, Health Resources economics, Hemostatic Techniques instrumentation, Humans, Length of Stay economics, Male, Middle Aged, Pain Measurement, Tissue Adhesives, Treatment Outcome, Angioplasty, Balloon, Coronary economics, Coronary Disease therapy, Hemostatic Techniques economics
- Abstract
We undertook a randomized controlled trial comparing VasoSeal, a collagen vascular hemostasis device (VHD), with manual compression to assess its role and potential cost savings in the PTCA population. Of 460 patients, 359 were excluded due to clinical instability (30%), groin problems (18%), suboptimal PTCA result (15%), and other reasons (37%). The remaining 101 patients were randomized to either VHD (51) or manual compression (50). Hemostasis time, time to ambulation, duration of hospital stay, and nursing time and intensity were significantly reduced in the VHD group. There were no major groin complications in either treatment arm but there was a trend toward more minor groin complications in the VHD patients. The application of VasoSeal reduced resource use in this randomized study and may translate into significant cost reductions in the general coronary angioplasty population.
- Published
- 1995
- Full Text
- View/download PDF
17. Femoral artery catheterization complications: a study of 503 consecutive patients.
- Author
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Bogart DB, Bogart MA, Miller JT, Farrar MW, Barr WK, and Montgomery MA
- Subjects
- Adult, Aged, Aged, 80 and over, Cardiac Catheterization methods, Female, Hemostasis physiology, Humans, Male, Middle Aged, Prospective Studies, Severity of Illness Index, Cardiac Catheterization adverse effects, Femoral Artery physiology, Hemostatic Techniques instrumentation, Vascular Diseases etiology
- Abstract
This report describes a prospective randomized trial of 503 patients who underwent a cardiac catheterization or interventional procedure at a single institution. In an effort to study femoral complications postprocedure, we evaluated three methods of femoral artery hemostasis as well as 38 variables that were felt to potentially relate to local complications. Only a marginally significant relationship between the hemostasis method and complication rate was found. The factors that contributed to femoral artery complications were: restarting heparin postsheath removal, number of procedures done during one hospitalization, noncompliance of the patient with bedrest after the procedure, number of arterial punctures to initiate the procedure, and preprocedure treatment with corticosteroids.
- Published
- 1995
- Full Text
- View/download PDF
18. Immediate arterial hemostasis after cardiac catheterization: initial experience with a new puncture closure device.
- Author
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Aker UT, Kensey KR, Heuser RR, Sandza JG, and Kussmaul WG 3rd
- Subjects
- Angioplasty, Balloon, Coronary, Biocompatible Materials, Collagen, Equipment Design, Female, Hematoma etiology, Humans, Lactates, Male, Middle Aged, Pilot Projects, Polyesters, Polymers, Punctures, Cardiac Catheterization, Femoral Artery, Hematoma prevention & control, Hemostatic Techniques instrumentation, Lactic Acid
- Abstract
A novel device for obtaining arterial hemostasis after invasive procedures was tested in 30 patients undergoing diagnostic catheterization (26 patients) or coronary angioplasty (4 patients). The device is deployed through an arterial sheath and forms a positive mechanical seal both inside and outside the defect in the arterial wall. The components are all bioabsorbable. Thirteen patients received a heparin bolus during the catheterization procedure. The activated clotting time recorded in 15 patients just prior to device deployment averaged 264 sec. 29 of 32 attempted device deployments were successful (91%); and the remaining 3 devices pulled completely out as called for by design in the event of incomplete deployment. Twenty-nine patients ultimately achieved successful hemostasis using the device, with the other patient receiving manual hemostasis. Of these 29, hemostasis was immediate and complete in 19 patients. Light digital pressure was required in another 8 patients for less than 5 min. There was minor delayed bleeding requiring supplemental light pressure in several cases. A total of 11 patients required supplemental pressure in addition to the hemostasis device. The use of bolus heparin was significantly (P = 0.05, Fisher's exact test) related to the requirement for supplemental pressure. Three patients developed hematomas, one of which was present prior to device deployment. The other two patients had received bolus heparin. No patient required transfusion or surgical repair. There was no change in the ankle/brachial systolic blood pressure index after device deployment or at late (30-60 day) follow-up. Ultrasound studies revealed no significant pathology relative to the device.(ABSTRACT TRUNCATED AT 250 WORDS)
- Published
- 1994
- Full Text
- View/download PDF
19. Improved anticoagulation management after Palmaz Schatz coronary stent implantation by sealing the arterial puncture site with a vascular hemostasis device.
- Author
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Kiemeneij F and Laarman GJ
- Subjects
- Female, Humans, Male, Middle Aged, Partial Thromboplastin Time, Retrospective Studies, Collagen administration & dosage, Coronary Vessels, Femoral Artery, Hemostatic Techniques adverse effects, Hemostatic Techniques instrumentation, Punctures, Stents
- Abstract
Sealing the arterial puncture site with a vascular hemostasis device has the potential to maintain optimal anticoagulation after stent implantation. The level of heparinization during the first 3 days after successful stent implantation was retrospectively compared between 2 groups of medically treated patients with (group A; n = 18) and without (group B; n = 17) a Vasoseal after sheath removal. The number of APTTs sampled in group A and B was 233 and 168, respectively. Respective mean values of APTT (seconds) in group A and B were 180 +/- 79 and 172 +/- 91 at day 1 (p = NS), 132 +/- 43 and 125 +/- 61 at day 2 (p = NS) and 123 +/- 36 and 116 +/- 48 at day 3 (p = NS). More APTTs were suboptimal (< 80 secs) in group B (34/168; 20%) compared to group A (17/233; 7%) [p < 0.001]. More patients in group B compared to group A had 1 or more (14/17; 82% vs. 8/18; 44%; p = 0.04), 2 or more (10/17; 59% versus 3/18; 17%; p = 0.02) and 3 or more (8/17; 47% vs. 2/18; 11%; p = 0.03) suboptimal APTTs. Bleeding complications were seen in 4 patients without and in 3 patients with a Vasoseal. Thus application of a vascular hemostasis device results in a less variable anticoagulation after coronary stenting, but it does not abolish entry site-related bleeding complications.
- Published
- 1993
- Full Text
- View/download PDF
20. Percutaneous vascular hemostasis device for interventional procedures.
- Author
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Merino A, Faulkner C, Corvalan A, and Sanborn TA
- Subjects
- Angioplasty, Balloon adverse effects, Animals, Collagen administration & dosage, Femoral Artery pathology, Hemostasis, Swine, Catheterization, Peripheral instrumentation, Femoral Artery injuries, Hemostatic Techniques instrumentation
- Abstract
A new 11.5F over-the-wire vascular hemostasis device was compared to conventional manual compression in normal swine femoral arteries. Using percutaneous techniques, the collagen was deposited and hemostasis achieved in 7 vessels after 1 minute total, plus 4 minutes partial compression, while control manual compression required more than 5 minutes total compression to avoid hematoma formation. One month follow-up of treated arteries (n = 4) and controls (n = 3) showed no impairment in distal pulse or differences in histology at the puncture site in the control and treated arteries. Thus, the vascular hemostasis device technique is safe and effective, achieves hemostasis with less compression time and complications, and does not interfere with arterial wall healing or compromise the lumen.
- Published
- 1992
- Full Text
- View/download PDF
21. Initial experience with a new compression device for hemostasis after femoral arterial puncture.
- Author
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Roth R, Modrosic K, Brown M, and Kern MJ
- Subjects
- Cardiac Catheterization, Catheterization, Peripheral, Equipment Design, Humans, Pressure, Punctures, Time Factors, Femoral Artery, Hemostatic Techniques instrumentation
- Abstract
We evaluated a new hemostasis device to maintain focused pressure over the femoral artery puncture site for 2-6 hours in 330 cases after diagnostic catheterization or coronary angioplasty. No patient developed later hematoma or vascular complications. The initial favorable experience suggests that this hemostasis device has advantageous features of stability and site visualization and is a suitable adjunct to current methods of maintaining puncture site pressure after brief manual compression following arterial catheterization.
- Published
- 1992
- Full Text
- View/download PDF
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