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Caymaz I, Nurili F, Kolcak O, Aras O, Gumus B. Success and reliability of extrafemoral Exoseal vascular closure device: “Off-label” usage. Interv Med Appl Sci 2020; 11:182-186. [PMID: 36343285 PMCID: PMC9467335 DOI: 10.1556/1646.11.2019.22] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 10/08/2017] [Revised: 10/20/2018] [Accepted: 07/07/2019] [Indexed: 12/01/2022] Open
Abstract
Aim The aim of this study is to present the reliability and efficacy of Exoseal vascular closure device (EVCD) for closure of extrafemoral punctures. Materials and methods All patients who were treated with EVCD following arterial endovascular treatment involving an extrafemoral puncture between April 2013 and January 2014 were examined retrospectively. This study included 11 patients (4 women and 7 men between the ages of 48 and 87 years; average age = 65 years). A total of 13 procedures were performed in 11 patients involving the following access routes: brachial artery (n = 5), popliteal artery (n = 4), and polytetrafluoroethylene graft (n = 4). Results Twelve out of 13 EVCD procedures achieved technical success and procedural success. One minor and one major complications occurred. Both complications were revealed to be pseudoaneurysms, both in the brachial artery. Pseudoaneurysm of the minor complication was treated by Fibrin Sealant (Tisseel) injection guided by ultrasonography and the other pseudoaneurysm was treated by covered stent placement. Conclusions The femoral artery is an essential access route of arterial endovascular procedures; however, in some cases, the extrafemoral arterial route is necessary. In this study, EVCD was found to be useful for closing extrafemoral arterial routes. This study had a limited number of cases and more large-scale studies are needed.
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Affiliation(s)
- Ismail Caymaz
- 1 Department of Interventional Radiology, Baskent Medical Faculty, Istanbul Training and Research Hospital, Istanbul, Turkey
- 2 Istanbul Medeniyet University Medical School, Goztepe Training and Research Hospital, Istanbul, Turkey
| | - Fuad Nurili
- 3 Department of Radiology, Weil Cornell Medical College, New York, NY, USA
| | - Ozlem Kolcak
- 4 Department of Interventional Radiology, Kartal Dr. Lutfi Kirdar Training and Research Hospital, Istanbul, Turkey
| | - Omer Aras
- 5 Department of Radiology, Memorial Sloan Kettering Cancer Center, New York, NY, USA
| | - Burcak Gumus
- 1 Department of Interventional Radiology, Baskent Medical Faculty, Istanbul Training and Research Hospital, Istanbul, Turkey
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Han Y, Kwon JH, Park S. Korean single-center experience with femoral access closure using the ExoSeal device. World J Radiol 2018; 10:108-115. [PMID: 30310545 PMCID: PMC6177558 DOI: 10.4329/wjr.v10.i9.108] [Citation(s) in RCA: 3] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 04/27/2018] [Revised: 08/06/2018] [Accepted: 08/24/2018] [Indexed: 02/06/2023] Open
Abstract
AIM To report 17-mo experience of femoral artery puncture site closure during angiographic procedures using ExoSeal vascular closure devices (VCDs).
METHODS Between November 2015 and April 2017, we performed 179 diagnostic and interventional angiographic procedures via a common femoral arterial access. The ExoSeal VCD was used at the puncture site to achieve hemostasis in 125 patients. We evaluated the technical and procedural success rates, the complications, and the factors affecting the hemostasis time of the ExoSeal VCDs.
RESULTS Technical and procedural successes were achieved in 176 cases (98.0%) and 128 cases (71.5%), respectively. Device failure occurred in 3 (1.7%) cases. In 1 case (0.6%) a small hematoma developed, but there were no major complications. Among the hemostasis-relevant variables, a history of drinking alcohol, low platelet (PLT) count, and high prothrombin time-international normalized ratio (commonly known as PT-INR) values were the statistically significant predictors of the need for longer manual compression (MC). There was no difference in the success rates between the repeat and single ExoSeal procedure groups, and repeated use of the ExoSeal did not affect hemostasis time.
CONCLUSION The ExoSeal VCD effectively achieves hemostasis, with few complications. Longer light MC may be needed with alcohol drinkers, low PLT count, and high PT-INR values.
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Affiliation(s)
- Yoonhee Han
- Department of Radiology, Dongguk University Ilsan Hospital, Goyang-si 10326, Gyeonggi-do, South Korea
| | - Jae Hyun Kwon
- Department of Radiology, Dongguk University Ilsan Hospital, Goyang-si 10326, Gyeonggi-do, South Korea
| | - Surin Park
- Department of Radiology, Dongguk University Ilsan Hospital, Goyang-si 10326, Gyeonggi-do, South Korea
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Amer O, Binger S, Desch S, Harnoss HM, Schuler G, Thiele H, Eitel I. Incidence, predictors, and treatment options of critical limb ischaemia after use of collagen plug-based vascular closure devices. EUROINTERVENTION 2015; 11:816-23. [PMID: 26603989 DOI: 10.4244/eijv11i7a166] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/23/2022]
Abstract
AIMS Limited data are available on the frequency and predictors of vascular closure device (VCD) failure with subsequent vascular complications. The aim of this study was to investigate the incidence, clinical characteristics, and treatment options in patients with critical limb ischaemia (CLI) after use of a collagen plug-based VCD. METHODS AND RESULTS A high-volume, single-centre prospectively maintained database was retrospectively interrogated, and cases of collagen plug-based VCD-related CLI were identified between June 2006 and December 2013. CLI was defined as acute onset of rest pain after VCD application requiring endovascular or surgical treatment. Among 13,595 coronary procedures, 43 patients (0.3%) were identified with an Angio-Seal-related CLI. In a multivariable logistic regression analysis, peripheral artery disease and renal insufficiency were identified as independent predictors for CLI after Angio-Seal application. Treatment was performed in 27 patients (63%) by surgery and in 16 patients (37%) with endovascular angioplasty. CONCLUSIONS CLI after use of a collagen plug-based VCD is rare. Peripheral artery disease was identified as an independent predictor of CLI. Interventional cardiologists should be aware of potentially high-risk patients and complications after use of a VCD to provide prompt and adequate therapy.
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Affiliation(s)
- Omran Amer
- Department of Internal Medicine - Cardiology, University of Leipzig - Heart Center, Leipzig, Germany
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Patient Satisfaction After Femoral Arterial Access Site Closure Using the ExoSeal® Vascular Closure Device Compared to Manual Compression: A Prospective Intra-individual Comparative Study. Cardiovasc Intervent Radiol 2015; 39:21-7. [DOI: 10.1007/s00270-015-1204-2] [Citation(s) in RCA: 7] [Impact Index Per Article: 0.7] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/19/2015] [Accepted: 08/16/2015] [Indexed: 01/13/2023]
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Comparison of Exo-Seal(®) and Angio-Seal (®) for arterial puncture site closure: A randomized, multicenter, single-blind trial. Herz 2015; 40:809-16. [PMID: 26070467 DOI: 10.1007/s00059-015-4306-3] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/08/2014] [Revised: 12/22/2014] [Accepted: 01/11/2015] [Indexed: 01/27/2023]
Abstract
BACKGROUND The use of extravascular femoral closure devices in patients undergoing coronary angiography/intervention has not been sufficiently evaluated. We sought to define the impact of an extravascular polyglycolic acid (PGA) plug for the closure of a femoral access site in patients undergoing coronary angiography and/or percutaneous coronary intervention. METHODS In this prospective, single-blind, multicenter trial we randomly assigned 319 patients to vessel closure with Angio-Seal(®) or Exo-Seal(®). We hypothesized that the use of an extravascular closure device is not inferior to an anchor/plug-mediated device regarding the occurrence of the composite primary endpoint: hematoma > 5 cm, significant groin bleeding (TIMI major bleed), false aneurysm, and device failure. RESULTS There was no significant difference in patient baseline characteristics or procedural results. After 24 h the primary endpoint occurred in nine patients (5.6 %) in the Angio-Seal(®) group and in 13 patients (8.2 %) inthe Exo-Seal(®) group (p = 0.38). Hematoma > 5 cm was noted in three patients (1.9 %) receiving Angio-Seal(®) vs. two patients (1.3 %) receiving Exo-Seal(®) (p = 0.99). In one patient (0.6 %) of the Exo-Seal(®) group, TIMI major bleeding occurred, requiring transfusion (p = 0.49). There were four (2.5 %) false aneurysms found in patients treated with Angio-Seal(®) and two (1.3 %) in patients treated with Exo-Seal(®) (p = 0.68). There was a trend for a higher incidence of device failure in the Exo-Seal(®) group (1.2 vs. 5.2 %, p = 0.06). At telephone interview after 30 days, there was no significant difference found regarding the events readmission with surgery of puncture site, infection, bleeding, hematoma, or pain. CONCLUSION In the present study, there were no significant differences found regarding the occurrence of hematoma > 5 cm, major bleeding, false aneurysm, and device failure between Angio-Seal(®) and Exo-Seal(®) 24 h after device implantation.
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Krishna RK, Kherada N, Beohar N. Late onset iatrogenic limb ischaemia after deployment of an Angio-Seal vascular closure device. BMJ Case Rep 2015; 2015:bcr-2015-209393. [PMID: 25917071 DOI: 10.1136/bcr-2015-209393] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/04/2022] Open
Abstract
It is common practice to deploy a vascular closure device for access site closure after percutaneous angiography or cardiovascular interventions for immediate haemostasis and to facilitate early discharge. We encountered two octogenarian women who underwent and had subsequent vascular access site closure with Angio-Seal (St Jude) and who later presented with limb ischaemia needing surgical revascularisation. Our patients had undergone uneventful deployment of the Angio-Seal vascular closure device (VCD) at the right common femoral artery (CFA) access site with successful haemostasis. About 3 weeks later they presented with features of limb ischaemia needing further diagnostic work-up including repeat angiography, which revealed subtotal occlusion of right common femoral artery at the level of prior access and Angio-Seal deployment site. Both the patients underwent successful surgical repair with restoration of distal flow and resolution of symptoms. These cases illustrate the late presentation of VCD-related complications with limb ischaemia, needing surgical revascularisation.
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Affiliation(s)
- Rama K Krishna
- Department of Cardiology, Mount Sinai Medical Center, Miami Beach, Florida, USA
| | - Nisharahmed Kherada
- Department of Cardiology, Mount Sinai Medical Center, Miami Beach, Florida, USA
| | - Nirat Beohar
- Department of Cardiology, Mount Sinai Medical Center, Miami Beach, Florida, USA
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Boschewitz JM, Pieper CC, Andersson M, Nadal J, Schild HH, Meyer C. Efficacy and time-to-hemostasis of antegrade femoral access closure using the ExoSeal vascular closure device: a retrospective single-center study. Eur J Vasc Endovasc Surg 2014; 48:585-91. [PMID: 25201516 DOI: 10.1016/j.ejvs.2014.08.006] [Citation(s) in RCA: 16] [Impact Index Per Article: 1.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/06/2014] [Accepted: 08/01/2014] [Indexed: 12/16/2022]
Abstract
OBJECTIVE To retrospectively evaluate the efficacy and time-to-hemostasis of antegrade femoral access closure using the ExoSeal vascular closure device (VCD). DESIGN Retrospective, single-center analysis. MATERIALS AND METHODS Between September 2010 and February 2013, 148 ExoSeal VCD closures (5-7F) of antegrade femoral accesses were performed in 119 patients (70 males, mean age 71.6 years, range 40-97 years). In all cases initial diagnostic angiography was performed via an 18G/3.8F retrograde femoral access, which was left in place during intervention (in-house standard) and was used to obtain control angiography after successful closure of the antegrade access to determine hemostasis. Technical device success was defined as ExoSeal closure without major VCD-related complications; procedural success as hemostasis within 5 minutes. Statistical analysis was performed using a logistic regression model and correlation analyses. RESULTS 145/148 (98.0%) ExoSeal closures were technically successful (5F: n = 76; 6F: n = 65; 7F: n = 7). Angiographic control showed closure after 2 minutes in 130/145 cases. In a further 14 cases hemostasis was achieved after an additional 3 minutes MC, so that closure was successful within 5 minutes in 144/148 cases (97.3%). No major complication occurred. One minor complication was recorded in a 6F access case. Pre-interventional activated partial thromboplastin time (aPTT) was the only statistically significant predictor of necessary manual compression (MC) > 2 minutes (p = .01), but with an odds-ratio of only 1.038. The INR showed an odds-ratio of 2.455 for need for 5 minutes MC (NS). Significant correlations were found between the need for 5 minutes MC and medication with acetylsalicylic acid (p = .01), clopidogrel (p < .01), and abciximab (p < .001). CONCLUSION ExoSeal vascular closure of antegrade femoral punctures is safe and effective with a low complication rate. Two minutes of MC are sufficient to achieve hemostasis in the majority of cases. However, in patients on antiplatelet therapy, especially after abciximab, the authors advocate prolonging MC to 5 minutes.
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Affiliation(s)
- J M Boschewitz
- Department of Radiology, University of Bonn, Bonn, Germany
| | - C C Pieper
- Department of Radiology, University of Bonn, Bonn, Germany
| | - M Andersson
- Department of Radiology, University of Bonn, Bonn, Germany
| | - J Nadal
- Institute for Medical Biometry, Informatics and Epidemiology, University of Bonn, Bonn, Germany
| | - H H Schild
- Department of Radiology, University of Bonn, Bonn, Germany
| | - C Meyer
- Department of Radiology, University of Bonn, Bonn, Germany.
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Vascular closure devices after endovascular procedures in swine: a reliable method? ScientificWorldJournal 2014; 2014:514942. [PMID: 24737976 PMCID: PMC3967389 DOI: 10.1155/2014/514942] [Citation(s) in RCA: 1] [Impact Index Per Article: 0.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Received: 12/03/2013] [Accepted: 01/21/2014] [Indexed: 11/18/2022] Open
Abstract
Purpose. To investigate the safety and feasibility of the use of a vascular closure device (VCD) after endovascular procedures in swine. Material and Methods. In a study on endovascular therapy, VCD (StarClose, Abbott Vascular, Il, USA) was used in 20 female swines to achieve immediate hemostasis after percutaneous right femoral artery (FA) access. 10 animals were sacrificed immediately after the study and 10 animals were sacrificed 28 days after the initial study. To ensure complete hemostasis and patency of the femoral artery, a CT-angiography of the puncture site was performed on day 1 (acute and chronic group) and day 28 (chronic group). After the sacrifice, the femoral artery was explanted and examined macroscopically for signs of VCD dysfunction. Results. Technical success rate was 100% with immediate hemostasis being achieved in all animals. No animals showed evidence of hematoma. During explantation, only small traces of coagulated blood were found in the acute group, while there were no signs of hematoma in the chronic group. CT-angiography immediately after VCD application as well as before sacrifice (chronic group) showed patency of the FA in all cases. Conclusion. The use of VCD to achieve hemostasis after endovascular studies in swine is feasible and safe.
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Feasibility of vascular access closure in arteries other than the common femoral artery using the ExoSeal vascular closure device. Cardiovasc Intervent Radiol 2014; 37:1352-7. [PMID: 24525965 DOI: 10.1007/s00270-014-0853-x] [Citation(s) in RCA: 12] [Impact Index Per Article: 1.1] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 11/20/2013] [Accepted: 01/21/2014] [Indexed: 01/27/2023]
Abstract
PURPOSE To describe the feasibility of vascular access closure in arteries other than the common femoral artery (CFA) using the ExoSeal vascular closure device (VCD). MATERIALS AND METHODS Between December 2011 and August 2013, 8 patients (4 males, 4 females, mean age 64 years [range 42-81]) underwent 13 extrafemoral access site closure using the ExoSeal VCD (brachial artery n = 7, venous femoropopliteal bypass n = 3, femoropopliteal segment n = 2, proximal superficial femoral artery n = 1). Patient history, procedural characteristics, and complications were recorded. RESULTS Technical success was achieved in 12 of 13 VCD procedures. In 1 case of brachial puncture, safe plug-deployment was not possible, so manual compression was applied. In this case, angiographic and clinical control showed residual bleeding 5 min after the procedure. After additional manual compression for 5 min, the haemorrhage stopped, but a hematoma <3 cm was detectable (procedural success rate 12 of 13 closures). Overall no major complications were observed. Heparin, 5,000 IU, was administered in all cases. Six ExoSeal closures were performed under additional acetylsalicylic acid (ASS) and clopidogrel, three under additional ASS, and the remaining four under heparin only. International normalized ratio and thrombocytes were within normal values in all patients. CONCLUSION Successful vascular access closure using the ExoSeal VCD in puncture sites other than the CFA is feasible with a low complication rate. These applications, however, remain an "off-label" use in selected patients.
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Boschewitz JM, Andersson M, Naehle CP, Schild HH, Wilhelm K, Meyer C. Retrospective evaluation of safety and effectiveness of the EXOSEAL vascular closure device for single vascular closure and closure after repeat puncture in diagnostic and interventional radiology: single-center experience. J Vasc Interv Radiol 2013; 24:698-702. [PMID: 23622041 DOI: 10.1016/j.jvir.2013.02.014] [Citation(s) in RCA: 20] [Impact Index Per Article: 1.7] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 09/25/2012] [Revised: 02/12/2013] [Accepted: 02/12/2013] [Indexed: 12/14/2022] Open
Abstract
PURPOSE To retrospectively evaluate the safety and effectiveness of the EXOSEAL vascular closure device (VCD) for first or repeated closure after retrograde percutaneous femoral arterial access. MATERIALS AND METHODS A retrospective analysis of 417 patients (271 men; mean age, 64.1 y±12.8; age range, 22-94 y) who had undergone arterial closure with the EXOSEAL VCD was performed. Procedures with retrograde femoral access and closure with the 5-F, 6-F, or 7-F EXOSEAL VCD according to the manufacturer's instructions were included. The clinical indications included the full procedural portfolio of a radiologic department with a focus on transarterial hepatic procedures. After EXOSEAL VCD closure, patients were restricted to bed rest for 4 hours. RESULTS From August 2010 to March 2012, a total of 682 EXOSEAL VCDs (5-F, n = 276; 6-F, n = 394; 7-F, n = 12) were used in 659 procedures with a total of 404 repeated closures. The EXOSEAL VCD was used successfully in 676 of 682 procedures (99.1%). Hemostasis was achieved in 651 of 682 procedures (95.5%). No major complications were encountered. There were eight cases (1.17%) of minor complications despite a successful vascular closure procedure, none requiring further therapy. There were no complications in any of the 404 cases of repeated vascular closure. CONCLUSIONS The results of this study suggest that the EXOSEAL VCD is safe and effective in single and repeated closure of retrograde percutaneous femoral arterial access in interventional radiology cases.
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Affiliation(s)
- Jack M Boschewitz
- Department of Radiology, University of Bonn, Sigmund-Freud-Strasse 25, D-53105 Bonn, Germany
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Clinical and economic evaluation of ambulatory endovascular treatment of peripheral arterial occlusive lesions. Ann Vasc Surg 2013; 28:137-43. [PMID: 24183403 DOI: 10.1016/j.avsg.2013.06.008] [Citation(s) in RCA: 14] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/18/2013] [Revised: 06/11/2013] [Accepted: 06/13/2013] [Indexed: 11/21/2022]
Abstract
BACKGROUND Ambulatory management of patients is an alternative to conventional hospitalization. In this study we evaluate the results of a prospective cohort study of patients receiving ambulatory endovascular treatment for peripheral arterial lesions. METHODS From June 2008 to October 2010, ambulatory management was proposed for endovascular treatment of peripheral arterial lesions. An arterial closure device (Angio-Seal(®); St. Jude Medical) was used. For ambulatory treatment, patients were prohibited from driving a vehicle at discharge, had to be accompanied the first night after the procedure, had to live <1 hour from a medical facility, had to be reachable by telephone the day after the intervention, and had to remain hospitalized in the event of a complication. The principal criterion was morbimortality at 1 month. Secondary criteria were clinical improvement, patency, complications related to the arterial closure, and costs evaluation at 1 month. RESULTS Forty-five patients were included and 50 ambulatory procedures were carried out. The patients presented with claudication (92%) or a critical ischemia (8%) of the lower extremities. All procedures were carried out by femoral puncture (retrograde in 94% and anterograde in 6% of the cases). The patients presented with iliac (68%) and femoropopliteal (64%) lesions. Lesions included stenoses (70%), thromboses (16%), and intrastent restenoses (14%). The rate of failure of ambulatory hospitalization was 16% (n = 8) without a serious undesirable event: 2 patients were hospitalized after a surgical conversion for iliac rupture and disinsertion of stent; 3 patients developed a hematoma during the intervention at the point of puncture; and in 3 cases the system of percutaneous closure failed. The mean duration of hospitalization was 1.36 ± 1.33 days. At 1 month, clinical improvement was observed in 97.5% of cases, with a primary patency of 100%. No perioperative rehospitalization or puncture site complications were observed. Ambulatory management made it possible to save 42 days of hospitalization, with associated costs of 10,971€, compared with conventional hospitalization. The additional costs related to use of the Angio-Seal amounted to 7427€. CONCLUSION Ambulatory endovascular treatment of patients presenting with peripheral arterial lesions is reliable and effective and may contribute to savings in healthcare spending.
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Modi S, Gadvi R, Babu S. Initial experience with Angioseal™: Safety and efficacy of the endovascular closure device. Indian J Radiol Imaging 2013; 23:134-8. [PMID: 24082477 PMCID: PMC3777322 DOI: 10.4103/0971-3026.116566] [Citation(s) in RCA: 5] [Impact Index Per Article: 0.4] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/25/2022] Open
Abstract
Background: Vascular access site management is crucial to safe, efficient, and comfortable diagnostic or interventional percutaneous procedures. The Angioseal™ vascular closure device has been shown to be safe and effective in reducing the time to hemostasis following angiographic or interventional procedures. Relatively few studies have been conducted in the UK to assess the safety and efficacy of the device in a local setting. Materials and Methods: Data were retrospectively reviewed on 147 patients who underwent either diagnostic angiography or percutaneous interventional procedures from January 2008 to October 2009, and who had the femoral access site closed by 6F VIP Angioseal. A total of 147 patients (F: 49, M: 98), including 80 right femoral punctures, 57 left femoral punctures, and 10 bilateral punctures were reviewed using radiological reports and patients’ clinical data. Data on antiplatelet and anticoagulant therapy were recorded. All procedures were carried out by two interventional radiologists at a single institution, under similar operating conditions. Results: There were a total of six complications (4.47%), of which one was a major complication (0.75%), i.e., retroperitoneal bleed. There were five minor complications (3.73%), which included device deployment failure (2), device malfunction (2), and a superficial hematoma (>6 cm). Total complications were 6 out of 157 (3.8%) [95% CI = 0.8-6.8%)]. Successful hemostasis was achieved in less than 5 min in over 97% of patients. Successful device deployment was seen in over 98% of cases. Conclusion: We conclude that in our experience, the Angioseal vascular closure device is a safe and efficient means of achieving hemostasis post antegrade or retrograde puncture for diagnostic and percutaneous intervention procedures.
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Affiliation(s)
- Sachin Modi
- Department of Interventional Radiology, Sandwell and West Birmingham NHS Trust, Birmingham, West Midlands, UK
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Isfort P, Urban U, Mahnken AH, Penzkofer T, Bruners P, Pfeffer J, Steinseifer U, Günther RW, Schmitz-Rode T. Animal experimental evaluation of a new sealing device for indwelling arterial catheters. Acta Radiol 2013; 54:521-5. [PMID: 23474769 DOI: 10.1177/0284185113476022] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/16/2022]
Abstract
BACKGROUND Hematoma is a common complication following arterial puncture. To date no device that allows sealing of an arterial puncture site with in-situ catheter has been developed. PURPOSE To evaluate a newly developed arterial sealing device for endovascular catheters in an in-vivo experimental setting. MATERIAL AND METHODS A peelable collagen-based vascular sealing device for endovascular catheters was tested in acute (follow-up: 4 h; n = 2) and chronic (follow-up: 1 week; n = 4) settings in the femoral artery (FA) of sheep. After implantation correct position of the device as well as patency of the FA were verified angiographically. In the chronic group, hematoma was excluded and patency of FA was assured using color Doppler ultrasound 1 and 3 days after the procedure. After 1 week a final ultrasound and an angiography were performed for final evaluation. Thereafter, the animals were sacrificed and the puncture site was dissected and analyzed macroscopically. RESULTS Sufficient sealing of the puncture site could be observed in all animals. In acute and chronic experiments, neither a hematoma at the puncture site nor other complications were observed after positioning the sealing device. Follow-up color Doppler ultrasounds (CDUS) and final angiography revealed patent FAs in all animals. Macroscopic evaluation of dissection material proved collagen plug and catheter being in place. CONCLUSION Our preliminary in-vivo results demonstrate a safe and convenient vascular sealing system for endovascular catheters. No acute or chronic complications were observed.
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Affiliation(s)
- Peter Isfort
- Department of Diagnostic and Interventional Radiology, RWTH Aachen University Hospital, Aachen
| | - Ute Urban
- Department of Cardiovascular Engineering (CVE), Institute of Applied Medical Engineering (AME) – Helmholtz Institute, RWTH Aachen University, Aachen, Germany
| | - Andreas Horst Mahnken
- Department of Diagnostic and Interventional Radiology, RWTH Aachen University Hospital, Aachen
| | - Tobias Penzkofer
- Department of Diagnostic and Interventional Radiology, RWTH Aachen University Hospital, Aachen
| | - Philipp Bruners
- Department of Diagnostic and Interventional Radiology, RWTH Aachen University Hospital, Aachen
| | - Joachim Pfeffer
- Department of Diagnostic and Interventional Radiology, RWTH Aachen University Hospital, Aachen
| | - Ulrich Steinseifer
- Department of Cardiovascular Engineering (CVE), Institute of Applied Medical Engineering (AME) – Helmholtz Institute, RWTH Aachen University, Aachen, Germany
| | - Rolf Wilhelm Günther
- Department of Diagnostic and Interventional Radiology, RWTH Aachen University Hospital, Aachen
| | - Thomas Schmitz-Rode
- Department of Cardiovascular Engineering (CVE), Institute of Applied Medical Engineering (AME) – Helmholtz Institute, RWTH Aachen University, Aachen, Germany
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Smilowitz NR, Kirtane AJ, Guiry M, Gray WA, Dolcimascolo P, Querijero M, Echeverry C, Kalcheva N, Flores B, Singh VP, Rabbani L, Kodali S, Collins MB, Leon MB, Moses JW, Weisz G. Practices and complications of vascular closure devices and manual compression in patients undergoing elective transfemoral coronary procedures. Am J Cardiol 2012; 110:177-82. [PMID: 22482861 DOI: 10.1016/j.amjcard.2012.02.065] [Citation(s) in RCA: 52] [Impact Index Per Article: 4.0] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 01/25/2012] [Revised: 02/28/2012] [Accepted: 02/28/2012] [Indexed: 11/26/2022]
Abstract
Femoral arterial puncture is the most common access method for coronary angiography and percutaneous coronary interventions (PCIs). Access complications, although infrequent, affect morbidity, mortality, costs, and length of hospital stay. Vascular closure devices (VCDs) are used for rapid hemostasis and early ambulation, but there is no consensus on whether VCDs are superior to manual compression (MC). A retrospective review and nested case-control study of consecutive patients undergoing elective transfemoral coronary angiography and PCI over 3 years was performed. Hemostasis strategy was performed according to the operators' discretion. Vascular complications were defined as groin bleeding (hematoma, hemoglobin decrease ≥3 g/dl, transfusion, retroperitoneal bleeding, or arterial perforation), pseudoaneurysm, arteriovenous fistula formation, obstruction, or infection. Patients with postprocedure femoral vascular access complications were compared to randomly selected patients without complication. Data were available for 9,108 procedures, of which PCI was performed in 3,172 (34.8%). MC was performed in 2,581 (28.3%) and VCDs (4 different types) were deployed in 6,527 procedures (71.7%). Significant complications occurred in 74 procedures (0.81%), with 32 (1.24%) complications with MC and 42 (0.64%) with VCD (p = 0.004). VCD deployment failed in 80 procedures (1.23%), of which 8 (10%) had vascular complications. VCD use was a predictor of fewer complications (odds ratio 0.52, 95% confidence interval 0.33 to 0.83). In the case-control analysis, older age and use of large (7Fr to 8Fr) femoral sheaths were independent predictors of complications. In conclusion, the retrospective analysis of contemporary hemostasis strategies and outcomes in elective coronary procedures identified a low rate of complications (0.81%), with superior results after VCD deployment. Careful selection of hemostasis strategy and closure device may further decrease complication rates.
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Georg Y, Thaveau F, Lejay A, Bajcz C, Bakassa S, Chakfe N, Kretz JG. Arterial thrombosis after using Angio-Seal. Ann Vasc Surg 2012; 25:1078-93. [PMID: 22023942 DOI: 10.1016/j.avsg.2010.11.021] [Citation(s) in RCA: 10] [Impact Index Per Article: 0.8] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 06/07/2010] [Revised: 10/04/2010] [Accepted: 11/09/2010] [Indexed: 12/17/2022]
Abstract
Percutaneous closure systems of arterial puncture sites are being used more and more in modern endovascular practice. In this article, we report five cases of thrombotic complications following Angio-Seal deployment which required to be treated in our department between June 2004 and January 2006. We carried out a computerized literature review using "vascular closure" as a keyword and elected 106 articles published between 1992 and 2007. The analysis of this literature review showed that the rate of percutaneous closure complications was similar to the rate of manual compression complications, which is still the reference method. The complications associated with the use of these systems were more complex and more often required surgical repair. The severity and frequency of these complications differ based on the type of closure systems. The vascular surgeon in charge must have a good knowledge of these systems and of the complications each of them entails to be able to treat them in the most appropriate way.
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Affiliation(s)
- Yannick Georg
- Service de Chirurgie Vasculaire, Nouvel Hôpital Civil, Strasbourg, France
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Brott TG, Halperin JL, Abbara S, Bacharach JM, Barr JD, Bush RL, Cates CU, Creager MA, Fowler SB, Friday G, Hertzberg VS, McIff EB, Moore WS, Panagos PD, Riles TS, Rosenwasser RH, Taylor AJ. 2011 ASA/ACCF/AHA/AANN/AANS/ACR/ASNR/CNS/SAIP/SCAI/SIR/SNIS/SVM/SVS Guideline on the Management of Patients With Extracranial Carotid and Vertebral Artery Disease. J Am Coll Cardiol 2011; 57:e16-94. [PMID: 21288679 DOI: 10.1016/j.jacc.2010.11.006] [Citation(s) in RCA: 188] [Impact Index Per Article: 13.4] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/20/2022]
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Brott TG, Halperin JL, Abbara S, Bacharach JM, Barr JD, Bush RL, Cates CU, Creager MA, Fowler SB, Friday G, Hertzberg VS, McIff EB, Moore WS, Panagos PD, Riles TS, Rosenwasser RH, Taylor AJ. 2011 ASA/ACCF/AHA/AANN/AANS/ACR/ASNR/CNS/SAIP/SCAI/SIR/SNIS/SVM/SVS guideline on the management of patients with extracranial carotid and vertebral artery disease. Stroke 2011; 42:e464-540. [PMID: 21282493 DOI: 10.1161/str.0b013e3182112cc2] [Citation(s) in RCA: 96] [Impact Index Per Article: 6.9] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 12/18/2022]
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Brott TG, Halperin JL, Abbara S, Bacharach JM, Barr JD, Bush RL, Cates CU, Creager MA, Fowler SB, Friday G, Hertzberg VS, McIff EB, Moore WS, Panagos PD, Riles TS, Rosenwasser RH, Taylor AJ. 2011 ASA/ACCF/AHA/AANN/AANS/ACR/ASNR/CNS/SAIP/SCAI/SIR/SNIS/SVM/SVS guideline on the management of patients with extracranial carotid and vertebral artery disease. A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the American Stroke Association, American Association of Neuroscience Nurses, American Association of Neurological Surgeons, American College of Radiology, American Society of Neuroradiology, Congress of Neurological Surgeons, Society of Atherosclerosis Imaging and Prevention, Society for Cardiovascular Angiography and Interventions, Society of Interventional Radiology, Society of NeuroInterventional Surgery, Society for Vascular Medicine, and Society for Vascular Surgery. Circulation 2011; 124:e54-130. [PMID: 21282504 DOI: 10.1161/cir.0b013e31820d8c98] [Citation(s) in RCA: 59] [Impact Index Per Article: 4.2] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/22/2022]
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Thalhammer C, Joerg GR, Roffi M, Husmann M, Pfammatter T, Amann-Vesti BR. Endovascular treatment of Angio-Seal-related limb ischemia--primary results and long-term follow-up. Catheter Cardiovasc Interv 2010; 75:823-7. [PMID: 20146317 DOI: 10.1002/ccd.22407] [Citation(s) in RCA: 4] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/08/2022]
Abstract
OBJECTIVES To investigate primary success rates and long term follow-up of endovascular treatment of AngioSeal-related limb ischemia. BACKGROUND Current knowledge on optimal therapy of ischemic complications following application of AngioSeal is limited. METHODS A single-center prospectively maintained database was retrospectively interrogated and AngioSeal-related complications requiring endovascular treatment over an 8-year-time period was identified. RESULTS Fifteen patients fulfilling the inclusion criteria were identified, resulting in an approximated incidence of 0.26% of all devices implanted at our institution. In all cases, the complication was managed successfully in the absence of complications. Eleven patients were treated with balloon angioplasty (PTA) and four with stent implantation because of suboptimal PTA results. Twelve patients were available for noninvasive vascular follow-up examination for a median time of 40 months postinterventionally. Only two patients needed a second intervention consisting of balloon angioplasty due to symptomatic restenosis. At final follow-up all patients were asymptomatic with no relevant restenosis. CONCLUSION Endovascular treatment for AngioSeal-related limb ischemia with or without stent implantation results in an excellent immediate and long-term clinical and hemodynamic outcome.
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MAY OLE, SCHLOSSER HELLE, SKYTTE LENE. A High Blood Pressure Predicts Bleeding Complications and a Longer Hospital Stay after Elective Coronary Angiography Using the Femoral Approach. J Interv Cardiol 2009; 22:175-8. [DOI: 10.1111/j.1540-8183.2009.00427.x] [Citation(s) in RCA: 8] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/30/2022] Open
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Kahlert P, Eggebrecht H, Erbel R, Sack S. A modified "preclosure" technique after percutaneous aortic valve replacement. Catheter Cardiovasc Interv 2009; 72:877-84. [PMID: 19006257 DOI: 10.1002/ccd.21711] [Citation(s) in RCA: 42] [Impact Index Per Article: 2.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 12/17/2022]
Abstract
OBJECTIVES To evaluate the feasibility, safety and efficacy of suture-mediated closure devices using a modified "preclosure" technique for access site management after percutaneous aortic valve replacement (PAVR). BACKGROUND PAVR using a retrograde transfemoral approach has recently evolved to an endovascular alternative to open surgery in high-risk patients. However, large-bore femoral artery access is required, commonly demanding surgical closure and general anesthesia. A truly percutaneous intervention would be desirable to reduce procedural complexity and diminish the need of vascular surgery and general anaesthesia. METHODS After direct puncture of the common femoral artery, three conventional suture-mediated closure devices (6F Perclose) were deployed. The preloaded sutures were tied at the end of the procedure. If no immediate hemostasis was achieved, an additional device was deployed thereafter. RESULTS PAVR with percutaneous access site closure was attempted in 15 consecutive patients and could successfully be achieved in all patients allowing conscious sedation in all but three cases. Following complications occurred: one retroperitoneal bleeding caused by removal of the valve delivery sheath requiring surgical repair, as well as two cases of femoral and iliac artery dissection caused by delivery sheath introduction and treated by stenting and vascular surgery, respectively. Vascular surgery became only necessary due to total vessel occlusion after suture closure and remains the only closure-related complication. However, treatment led to recovery in all patients. CONCLUSIONS The modified "preclosure" technique is a feasible and safe method for hemostasis after PAVR improving procedural management and diminishing the need for general anesthesia.
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Affiliation(s)
- Philipp Kahlert
- West German Heart Center Essen, Department of Cardiology, University Duisburg-Essen, Germany.
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Hieb RA, Neisen MJ, Hohenwalter EJ, Molnar JA, Rilling WS. Safety and effectiveness of repeat arterial closure using the AngioSeal device in patients with hepatic malignancy. J Vasc Interv Radiol 2008; 19:1704-8. [PMID: 18951046 DOI: 10.1016/j.jvir.2008.09.003] [Citation(s) in RCA: 11] [Impact Index Per Article: 0.6] [Reference Citation Analysis] [Abstract] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 11/14/2007] [Revised: 09/03/2008] [Accepted: 09/04/2008] [Indexed: 12/14/2022] Open
Abstract
PURPOSE To retrospectively evaluate the safety and effectiveness of the use of the AngioSeal device for repeat arterial closure in patients with hepatic malignancy. MATERIALS AND METHODS A retrospective analysis of patients with hepatic malignancy who had undergone repeated arterial closure with the AngioSeal device was performed. All charts for patients undergoing transarterial chemoembolization or TheraSphere radioembolization were reviewed for the method of hemostasis and the number of arterial closures. A total of 53 patients (58.5% men, 41.5% women; mean age, 58.7 years) had repeat AngioSeal arterial puncture closure after chemoembolization or TheraSphere treatment. Percutaneous closure of the common femoral artery with the AngioSeal device was performed in accordance with the manufacturer's recommendations. The patients were examined for complications on follow-up. Effectiveness was defined by the ability to obtain satisfactory hemostasis. Safety was assessed by the absence of groin complications and by vessel patency on follow-up angiograms of the puncture site obtained at subsequent liver-directed therapy sessions. RESULTS Fifty-three patients in this study group had a total of 203 common femoral artery punctures. There were a total of 161 closures with the AngioSeal device (79.3%): 58 (36%) single closures and 103 (64.0%) repeat closures. Of the 161 attempts at AngioSeal closure, there was one closure failure in the single-puncture group, yielding a success rate of 98.3%; and one closure failure in the repeat-puncture group, yielding a success rate of 99%. In these two patients, hemostasis was achieved with traditional manual compression without the need for any other device, and no complications were noted. The overall success rate of AngioSeal device closure was 98.7%. CONCLUSIONS The repeat use of the AngioSeal closure device is safe and effective in patients with hepatic malignancy undergoing regional oncologic interventional procedures.
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Affiliation(s)
- Robert A Hieb
- Department of Radiology, Medical College of Wisconsin-Froedtert Memorial Lutheran Hospital, 9200 West Wisconsin Avenue, Room 2803, Milwaukee, WI 53226, USA
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Schumacher PM, Ross CB, Wu YC, Donahue RM, Ranval TJ, Dattilo JB, Guzman RJ, Naslund TC. Ischemic complications of percutaneous femoral artery catheterization. Ann Vasc Surg 2007; 21:704-12. [PMID: 17980794 DOI: 10.1016/j.avsg.2007.05.001] [Citation(s) in RCA: 6] [Impact Index Per Article: 0.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 02/14/2007] [Revised: 04/02/2007] [Accepted: 05/30/2007] [Indexed: 11/19/2022]
Abstract
Ischemic injuries following percutaneous femoral artery catheterization are uncommon but have been associated with vascular closure devices (VCDs). The purpose of this study was to retrospectively compare ischemic and hemorrhagic complications of femoral artery catheterization and to identify factors associated with ischemic injuries. The operative registries of the attending vascular surgeons at one academic and two community hospitals were retrospectively reviewed to identify all complications of femoral artery catheterization requiring operative intervention. Demographic, clinical, procedural, operative, and outcome data were compared between patients who sustained ischemic and hemorrhagic complications. From January 2001 to December 2006, 95 patients required operative management of complications related to femoral artery catheterization including 40 patients who experienced ischemic (group 1) and 55 patients who experienced hemorrhagic (group 2) complications. Compared to those sustaining hemorrhagic complications, ischemic complications were more frequently associated with younger age, smoking, VCD deployment, and, when controlling for VCD use, female gender. Time to presentation was also significantly longer in patients experiencing ischemic complications. Ischemic complications are increasingly recognized following femoral artery catheterization. Vascular surgeons should anticipate a new pattern of injury following femoral artery catheterization, one that often requires complex arterial reconstruction.
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Affiliation(s)
- Paul M Schumacher
- Department of Vascular Surgery, Vanderbilt University Medical Center, Nashville, TN 37232-2735, USA
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Imam A, Carter RMS, Phillips-Hughes J, Boardman P, Uberoi R. StarClose Vascular Closure Device: Prospective Study on 222 Deployments in an Interventional Radiology Practice. Cardiovasc Intervent Radiol 2007; 30:738-42. [PMID: 17587083 DOI: 10.1007/s00270-007-9079-5] [Citation(s) in RCA: 24] [Impact Index Per Article: 1.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/17/2007] [Revised: 03/17/2007] [Accepted: 04/15/2007] [Indexed: 10/23/2022]
Abstract
The StarClose device (Abbott Vascular Devices; Abbott Laboratories, Redwood City, CA) utilizes an externally placed Nitinol clip to achieve arterial closure following femoral artery puncture. The objectives of this study were to assess the efficacy and complications of the StarClose device in patients undergoing interventional radiological procedures. Preprocedural clotting status, pulse and blood pressure, severity of vessel calcification, sheath size, and time to deployment were recorded. Postdeployment complications immediately postprocedure, at 1 h, at 2 h, and at 1 week were recorded. A duplex scan was performed in the first 10 patients to assess any immediate vascular complications. Deployments were successful in 96% achieving immediate hemostasis. Mean deployment time was 48 s. There were no major complications. The StarClose device was found to have a high technical and clinical efficacy.
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Affiliation(s)
- Atique Imam
- Department of Radiology, John Radcliffe Hospital, Headley Way, OX3 9DU, Headington, Oxford, UK
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Ferraris VA, Ferraris SP, Saha SP, Hessel EA, Haan CK, Royston BD, Bridges CR, Higgins RSD, Despotis G, Brown JR, Spiess BD, Shore-Lesserson L, Stafford-Smith M, Mazer CD, Bennett-Guerrero E, Hill SE, Body S. 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 2007; 83:S27-86. [PMID: 17462454 DOI: 10.1016/j.athoracsur.2007.02.099] [Citation(s) in RCA: 618] [Impact Index Per Article: 34.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 10/12/2006] [Revised: 01/21/2007] [Accepted: 02/08/2007] [Indexed: 01/24/2023]
Abstract
BACKGROUND A minority of patients having cardiac procedures (15% to 20%) consume more than 80% of the blood products transfused at operation. Blood must be viewed as a scarce resource that carries risks and benefits. A careful review of available evidence can provide guidelines to allocate this valuable resource and improve patient outcomes. METHODS We reviewed all available published evidence related to blood conservation during cardiac operations, including randomized controlled trials, published observational information, and case reports. Conventional methods identified the level of evidence available for each of the blood conservation interventions. After considering the level of evidence, recommendations were made regarding each intervention using the American Heart Association/American College of Cardiology classification scheme. RESULTS Review of published reports identified a high-risk profile associated with increased postoperative blood transfusion. Six variables stand out as important indicators of risk: (1) advanced age, (2) low preoperative red blood cell volume (preoperative anemia or small body size), (3) preoperative antiplatelet or antithrombotic drugs, (4) reoperative or complex procedures, (5) emergency operations, and (6) noncardiac patient comorbidities. Careful review revealed preoperative and perioperative interventions that are likely to reduce bleeding and postoperative blood transfusion. Preoperative interventions that are likely to reduce blood transfusion include identification of high-risk patients who should receive all available preoperative and perioperative blood conservation interventions and limitation of antithrombotic drugs. Perioperative blood conservation interventions include use of antifibrinolytic drugs, selective use of off-pump coronary artery bypass graft surgery, routine use of a cell-saving device, and implementation of appropriate transfusion indications. An important intervention is application of a multimodality blood conservation program that is institution based, accepted by all health care providers, and that involves well thought out transfusion algorithms to guide transfusion decisions. CONCLUSIONS Based on available evidence, institution-specific protocols should screen for high-risk patients, as blood conservation interventions are likely to be most productive for this high-risk subset. Available evidence-based blood conservation techniques include (1) drugs that increase preoperative blood volume (eg, erythropoietin) or decrease postoperative bleeding (eg, antifibrinolytics), (2) devices that conserve blood (eg, intraoperative blood salvage and blood sparing interventions), (3) interventions that protect the patient's own blood from the stress of operation (eg, autologous predonation and normovolemic hemodilution), (4) consensus, institution-specific blood transfusion algorithms supplemented with point-of-care testing, and most importantly, (5) a multimodality approach to blood conservation combining all of the above.
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Akopian G, Katz SG. Peripheral angioplasty with same-day discharge in patients with intermittent claudication. J Vasc Surg 2006; 44:115-8. [PMID: 16730157 DOI: 10.1016/j.jvs.2006.03.025] [Citation(s) in RCA: 44] [Impact Index Per Article: 2.3] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Received: 01/03/2006] [Accepted: 03/20/2006] [Indexed: 11/28/2022]
Abstract
BACKGROUND As the number of endovascular interventions increase and resources become scarce, surgeons need to be aware of cost-effective and efficient practice options. Many surgeons routinely admit their patients for overnight observation after uneventful endovascular interventions. Although this may be appropriate for patients with tissue loss and rest pain, we believe that peripheral angioplasty in patients with claudication can be safely performed as an outpatient procedure with significant cost savings. METHODS All patients with intermittent claudication undergoing peripheral angioplasty by a single vascular surgeon were enrolled prospectively in a same-day discharge protocol. Involved arteries and use of stent and closure device were recorded. Time to mobilization and time to discharge were determined. Patients were observed in an observation unit by a registered nurse, and were examined by the surgeon at the time of ambulation and before discharge. Patients were admitted to the hospital if complications arose during the predetermined observation period. Periprocedural complications and reasons for admission were noted. Patients were evaluated at 1 week, 6 weeks, and 3 to 6 months after the intervention. RESULTS During 27 months, 112 interventions were performed in 97 patients. The superficial femoral artery was the most frequent site of intervention (47%). Multiple sites had angioplasty in 27 (24%) procedures. Nine (8%) procedures resulted in admission. One patient was admitted for a major puncture site hematoma requiring blood transfusion, two patients for observation of a minor hematoma at the puncture site, one for chest pain, and one for observation of transient bradycardia. The mean time to mobilization was 1.4 +/- 1.3 hours, and the mean time to discharge was 2.8 +/- 1.2 hours. The average postprocedural cost for patients undergoing same-day discharge was $320 per patient, which contrasts with $1800 for routine overnight observation. No deaths or unplanned admissions to the hospital occurred < or =30 days of intervention. CONCLUSIONS Same-day discharge after peripheral angioplasty is safe and cost-effective. Need for admission is evident within 2 hours. Routine admission after peripheral angioplasty for patients with claudication is unnecessary and should no longer be the standard of care.
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Affiliation(s)
- Gabriel Akopian
- Department of Surgery, Division of Vascular Surgery, Keck School of Medicine, Huntington Hospital, Pasadena, CA 91105, USA
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Ansel G, Yakubov S, Neilsen C, Allie D, Stoler R, Hall P, Fail P, Sanborn T, Caputo RP. Safety and efficacy of staple-mediated femoral arteriotomy closure: Results from a randomized multicenter study. Catheter Cardiovasc Interv 2006; 67:546-53. [PMID: 16538688 DOI: 10.1002/ccd.20628] [Citation(s) in RCA: 22] [Impact Index Per Article: 1.2] [Reference Citation Analysis] [Abstract] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/06/2022]
Abstract
BACKGROUND Mechanical closure of percutaneous femoral arteriotomies following catheter based procedures remains problematic. METHODS The EVS closure device is the first to utilize a staple to effect arteriotomy closure and was compared to manual compression following sheath removal in a 362 patient randomized (2:1 to device) multicenter trial. As pre-specified, one half of the patients underwent coronary intervention. RESULTS Time to hemostasis was significantly reduced in the EVS group for both diagnostic (3.3 +/- 2.6 vs. 19.3 +/- 5.7 minutes; p < 0.001) and interventional procedures (5.5 +/- 5.1 vs. 22.3 +/- 9.9 minutes; p < 0.0001). Time to ambulation was similarly reduced in the EVS group following diagnostic (2.4 +/- 3.3 vs. 6.0 +/- 5.2 hours; p < 0.001) and interventional procedures (3.4 +/- 4.5 vs. 7.6 +/- 7.0 hours; p < 0.001). The incidence of major complications was similar between the EVS and manual compression groups at discharge (0.4% vs. 1.7%; p = NS) and at 30 day follow-up (0.4% vs. 2.5%; p = NS). CONCLUSION Compared to manual compression, the EVS device provides a safe and effective method of femoral artery closure.
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Affiliation(s)
- Gary Ansel
- Section of Cardiology, Riverside Methodist Hosptial, Columbus, Ohio, USA.
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Abstract
Percutaneous coronary interventional (PCI) procedures are commonly performed in the United States. The process of caring for this patient population has changed dramatically over the last 10 years, with many of the changes being driven by an evolution in the knowledge base underlying nursing practice. The purpose of this article is to provide a summary and critique of nurse-sensitive outcomes related to patients undergoing PCI procedures and to identify gaps in the literature to provide recommendations for future research. Nursing research on indicators related to costs of care, morbidity, symptom management, functional status, patient/family knowledge, patient responses, behavior, and home/occupational function following PCI are discussed in this review.
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MESH Headings
- Activities of Daily Living
- Angioplasty, Balloon, Coronary/adverse effects
- Angioplasty, Balloon, Coronary/economics
- Angioplasty, Balloon, Coronary/nursing
- Angioplasty, Balloon, Coronary/psychology
- Evidence-Based Medicine
- Health Care Costs
- Humans
- Morbidity
- Nursing Evaluation Research/organization & administration
- Outcome Assessment, Health Care/organization & administration
- Patient Education as Topic
- Quality Indicators, Health Care
- Quality of Life
- Recurrence
- Risk Reduction Behavior
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Affiliation(s)
- Barbara Leeper
- Cardiovascular Services, Baylor University Medical Center, Dallas, TX 75246, USA.
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Affiliation(s)
- Daniel B Brown
- Mallinckrodt Institute of Radiology, Washington University School of Medicine, 510 South Kingshighway Boulevard, St. Louis, Missouri 63110, USA.
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Vetrovec GW. The price for perhaps four hours of earlier ambulation. Catheter Cardiovasc Interv 2002; 57:496. [PMID: 12455084 DOI: 10.1002/ccd.10380] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Indexed: 11/11/2022]
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