Lokale Gefäßkomplikationen nach Einsatz des hämostatischen Verschlussystems Angio-SealTM

VASA ◽  
2002 ◽  
Vol 31 (2) ◽  
pp. 101-106 ◽  
Author(s):  
Kirchhof ◽  
Schickel ◽  
Schmidt-Lucke ◽  
Schmidt-Lucke

Background: As an alternative to manual pressure techniques new systems for achieving arterial hemostasis after cardiac catheterization were developed. Here we report about the diagnosis and therapy of femoral artery complications after use of the closure device Angio-SealTM, consisting of an intraarterial anchor and extravascular collagen plug. Patients and methods: Angio-SealTM was deployed in 350 patients undergoing cardiac catheterization. Vascular investigations after device application consisted of ankle/brachial-pressure-index measurement, duplex sonography, and angiography. Results: Vascular complications occurred in 10 of 350 patients. In two patients complete occlusions of the superficial femoral artery required immediate vascular surgery. Stenoses of the superficial (five patients) and the common (three patients) femoral arteries were diagnosed in 8 cases. Of these 10 patients eight were obese, in 2 cases there was a further catheterization with Angio-SealTM device application via the same femoral approach. Until now six patients underwent successful surgery: in 4 cases the whole Angio-SealTMdevice was located intraarterially, there was 1 case of intima-dissection, and 1 case remained unclear due to a diagnostic delay of 7 months. In three patients with stenoses of the common femoral arteries without hemodynamic relevance no therapy was required. Conclusions: Occlusions or stenoses of femoral arteries after use of Angio-SealTM can be diagnosed easily by duplex sonography. All hemodynamic relevant complications (n = 7 of 350 [2%]) concerned a puncture of superficial femoral arteries. In these patients vascular surgery seems to be an adequate therapy.

2008 ◽  
Vol 21 (2) ◽  
pp. 204-208 ◽  
Author(s):  
RAVI K. RAMANA ◽  
AMANDEEP SINGH ◽  
ROBERT S. DIETER ◽  
JOHN F. MORAN ◽  
LOWELL STEEN ◽  
...  

2012 ◽  
Vol 28 (5) ◽  
pp. 264-267 ◽  
Author(s):  
C Lekich ◽  
W Campbell ◽  
S Walton ◽  
P Hannah

Objectives: To discuss safety of EVLA in anomalies of the GSV anatomy. To review and discuss complications of surgery involving anomalous anatomy. Method: We report a case of high bifurcation of the common femoral artery wrapping around the saphenofemoral junction. Results: Successful ablation was achieved with no adverse consequences. Conclusion: EVLA is a safe treatment for SFJ/GSV incompetence in the presence of vascular anomalies that have historically resulted in serious vascular complications from surgery.


1998 ◽  
Vol 7 (4) ◽  
pp. 308-313 ◽  
Author(s):  
A Simon ◽  
B Bumgarner ◽  
K Clark ◽  
S Israel

BACKGROUND: Most cardiac catheterizations are performed via femoral artery access. Reported rates of both peripheral vascular complications and success rates for the use of manual and mechanical compression techniques to achieve femoral artery hemostasis after cardiac catheterization vary. OBJECTIVE: To determine is use of a mechanical clamp is as effective as standard manual pressure for femoral artery hemostasis after cardiac catheterization. METHODS: Subjects consisted of 720 patients from 2 community hospitals who had elective diagnostic cardiac catheterization via the femoral artery. The control group (n=343) received manual compression for hemostasis; the study group (n=377) received mechanical compression. Standard protocols were used for the 2 compression techniques. Pressure was applied for a minimum of 10 minutes for 5F and 6F sheaths and catheters and for a minimum of 15 minutes for 7F and 8F sheaths and catheters. Prospective data were collected and analyzed for each patients, including sheath or catheter size, blood pressure, height, weight, age, time from administration of local anesthetic to successful cannulation of the femoral artery, anticoagulation status, total compression time, physician performing the catheterization procedure, nurse or technician who obtained hemostasis, and complications. In follow-up, patients were asked site-specific and functional status questions 1 to 2 days after the catheterization procedure and again 3 days after the catheterization procedure. RESULTS: Data were analyzed by using frequency distributions, measures of central tendency, and measures of variability. Only 1 difference between the 2 groups was significant: manual compression time was 14.93 +/- minutes, whereas mechanical compression time was 17.13 +/- minutes. CONCLUSION: Mechanical compression is as effective as manual compression for femoral artery hemostasis after cardiac catheterization.


2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
G Sa Mendes ◽  
A Oliveira ◽  
R Campante Teles ◽  
P Araujo Goncalves ◽  
J Brito ◽  
...  

Abstract Background Vascular complications increase morbidity and mortality in transcatheter aortic valve implantation (TAVI). A collagen plug-based closure device - MANTA® was recently introduced as an alternative to the suture-mediated ProGlide® vascular closure device (VCD). Data regarding the efficacy and safety comparing both VCD is scarce. The present study sought to compare the effectiveness of both devices. Methods Single center retrospective analysis on prospectively collected data of 300 consecutive patients who underwent TAVI using MANTA® or ProGlide® since 2018. A 1:1 propensity-score matched population derived by a multivariate logistic regression model based on age, sex, body mass index, pre-procedural haemoglobin, EuroSCORE II, main access calcification and the sheath-to-artery ratio. The primary endpoint was the composite of major or life-threatening bleeding (VARC-2 definition), femoral artery stenosis/dissection, pseudoaneurysm and need for endovascular/surgical bailout intervention. Results The propensity score matching resulted in 129 matched pairs. The median age was 84 years old [IQR 80–87], 42% males with a median EuroSCOREII of 4.29% [IQR 3.05–6.24]. There were no differences in the primary endpoint between MANTA ® and ProGlide® cohorts (3.9% vs 7.8%, p=0.287, respectively). The rates of the primary endpoint with the MANTA® device decreased with center experience, with relatively steep learning curve effect concerning device success. Major or life-threatening bleeding (3.1% vs 5.4%, p=0.540) and pseudoaneurysm (0.8% vs 2.3%, p=0.622) occurred less frequently in MANTA® cohort, but the differences did not reach statistical significance. Endovascular (stent or balloon) or surgical rescue intervention (9.3% vs 5.4%, p=0.341) and femoral artery stenosis/dissection (6.2% vs 3.1%, p=0.376), were also similar rates. In ProGlide® cohort, to achieve VCD success (without primary endpoint events), 15.5% needed more than 2 devices, significantly different from MANTA ® (p<0,001). Conclusions In patients undergoing transfemoral TAVI, the MANTA® VCD showed a similar efficacy and safety compared to the ProGlide® device and it reduced significantly the need of additional VCDs for completion of hemostasis. These results were obtained despite a clear learning curve associated with MANTA. Funding Acknowledgement Type of funding source: None


2018 ◽  
Vol 53 (1) ◽  
pp. 58-61
Author(s):  
Young Jin Youn ◽  
Salman Khalid ◽  
Michael Azrin ◽  
Juyong Lee

Vascular closing devices (VCDs) are widely used to replace manual compression at the femoral puncture site and to reduce the discomfort of patients undergoing percutaneous coronary procedure by shortening bed rest. Among the vascular complications related to these devices, the femoral artery stenosis or occlusion is rarely reported, and its standard management is not well established. We report a case of symptomatic femoral artery stenosis caused by suture-mediated VCD and managed using rotational atherectomy device and balloon angioplasty. In addition, we propose the possible mechanisms for this complication.


Vascular ◽  
2007 ◽  
Vol 15 (1) ◽  
pp. 24-29 ◽  
Author(s):  
Nicholas J. Gargiulo ◽  
Frank J. Veith ◽  
Takao Ohki ◽  
Lawrence A. Scher ◽  
George L. Berdejo ◽  
...  

The intravascular and extravascular effects of percutaneous closure devices have not been well studied. We assessed the performance and healing characteristics in dogs of two devices approved by the US Food and Drug Administration. Nine adult male dogs were anesthesized prior to percutaneous access of both femoral arteries with a 6F sheath. All dogs were systemically heparinized to an activated clotting time (ACT) > 250 seconds. Duplex sonography was performed preoperatively to measure vessel diameter and flow velocity. In each dog, one of two devices (Perclose, Abbot Laboratories, Abbott Park, IL or Angio-Seal, St. Jude Medical, St. Paul, MN) was randomly deployed into one of the two femoral arteries. The other device was deployed on the opposite side. Duplex sonography was repeated immediately after deployment and 28 days later to measure changes in vessel diameter and flow velocity. At 28 days, angiography was performed on both femoral arteries before they were removed for histologic evaluation. The time required to excise each vessel reflected the degree of scarring. Hemostasis time for the Angio-Seal device far surpassed the Perclose device (39 ± 7 vs 0 minutes; p < .05). Vessel narrowing was observed only at 28 days after deployment of the Angio-Seal device ( p < .05). Extensive extravascular scarring was observed with the Angio-Seal device, which resulted in a longer femoral artery dissection time and greater periadventitial scar thickness compared with the Perclose device ( p < .05). When compared with the Perclose suture closure device, the Angio-Seal collagen plug closure device prolonged hemostasis time and produced greater vessel narrowing and periadventitial inflammation (extravascular scarring) in a canine model at 4 weeks.


2018 ◽  
Vol 12 (5) ◽  
pp. 141-144 ◽  
Author(s):  
Daniel Brancheau ◽  
Sinan Sarsam ◽  
Mahmoud Assaad ◽  
Marcel Zughaib

Background: Patients who are candidates to receive an Angioseal® (St. Jude Medical) device for arteriotomy closure are allowed to ambulate 20 min after the deployment of the device. More frequently, however, patients are kept on bed rest for several hours following Angioseal® deployment. The purpose of this study was to prospectively assess patients when ambulating 20 min after Angioseal® deployment instead of prolonged best rest of 2–3 h. Methods: Patients undergoing angiography from the common femoral artery approach were included in the study if they received a 6 Fr Angioseal® closure device. Results: Twenty-nine patients were successfully enrolled in the study; 27 (93.1%) patients ambulated at 20 min, 1 (3.45%) patient ambulated at 28 min, and 1 (3.45%) patient ambulated at 27 min due to transport times. There were zero complications with regard to hemorrhage or other groin complications. There is a substantial time difference in ambulation times between the conventional and early ambulation groups. Conclusion: Our study demonstrates that it is probably safe to ambulate patients who undergo diagnostic cardiac catheterization as early as 20 min after deployment of the 6 Fr Angioseal® closure device. ClinicalTrials.gov identifier: NCT03142126


2021 ◽  
Vol 2021 ◽  
pp. 1-7
Author(s):  
Anthony Matta ◽  
Ronan Canitrot ◽  
Vanessa Nader ◽  
Frederic Bouisset ◽  
Thibault Lhermusier ◽  
...  

Background. Vascular complications (VCs) are commonly observed after transfemoral transcatheter aortic valve implantation (TAVI) procedures. Closure devices for the access site were developed to reduce their incidence. We aim to evaluate the prevalence, predictors, and outcomes of the occurrence of post-TAVI VCs. Materials and Methods. A retrospective study was conducted on 1336 consecutive patients who underwent TAVI at the University Hospital of Toulouse, France, between January 2016 and March 2020. All included procedures were performed through the common femoral artery, and ProGlide® was the used closure device. The studied population was divided into two groups depending on the occurrence of VCs defined according to Valve Academic Research Consortium-2 criteria. Results. The mean age of the studied population was 84.4 ± 6.9, and 48% were male. 90% of TAVI interventions were performed through the right femoral artery. The prevalence of VCs was 18.8%, and 3.7% were major. Prolonged procedure duration was an independent predictor of VCs. Using the right access site and smaller introducer size (14 Fr) were preventive factors. No significant difference in mortality rate was detected between the two groups. Conclusion. This study showed a low prevalence for post-TAVI VCs, especially for the major type. An increase in bleeding events and prolonged cardiac care unit stay were the common adverse outcomes.


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