Balloon‐assisted injection of fibrin sealant for the treatment of postintervention access‐site bleeding complications

Background. The prevalence of peripheral vascular disease has led to the re-emergence of percutaneous axillary vascular access as a suitable alternative access site to femoral artery. We sought to investigate the efficacy and safety of manual hemostasis in the axillary artery. Methods. Data were collected from a prospective internal registry of patients who had a Maquet® (Rastatt, Germany) Mega 50 cc intra-aortic balloon pumps (IABP) placed in the axillary artery position. They were anticoagulated with weight-based intravenous heparin to maintain an activated partial thromboplastin time (aPTT) of 50–80 seconds. Anticoagulation was discontinued 2 hours prior to the device explantation. Manual compression was used to achieve the hemostasis of the axillary artery. Vascular and bleeding complications attributable to manual hemostasis were classified based on the Valve Academic Research Consortium-2 (VARC-2) and Bleeding Academic Research Consortium-2 (BARC-2) classifications, respectively. Results. 29 of 46 patients (63%) achieved axillary artery homeostasis via manual compression. The median duration of IABP implantation was 12 days (range 1–54 days). Median compression time was 20 minutes (range 5–60 minutes). There were no major vascular or bleeding complications as defined by the VARC-2 and BARC-2 criteria, respectively. Conclusion. Manual compression of the axillary artery appears to be an effective and safe method for achieving hemostasis. Large prospective randomized control trials may be needed to corroborate these findings.

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P1905Figure-of-eight stitch access site closure significantly reduces bleeding complications in patients undergoing cryoballoon ablation guided by intracardiac echocardiography

European Heart Journal ◽

10.1093/eurheartj/ehy565.p1905 ◽

2018 ◽

Vol 39 (suppl_1) ◽

Author(s):

V Rubesch-Kuetemeyer ◽

T Fischbach ◽

K J Gutleben ◽

D Horstkotte ◽

G Noelker

Keyword(s):

Intracardiac Echocardiography ◽

Bleeding Complications ◽

Cryoballoon Ablation ◽

Access Site

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Complex Large-Bore Radial percutaneous coronary intervention: rationale of the COLOR trial study protocol

BMJ Open ◽

10.1136/bmjopen-2020-038042 ◽

2020 ◽

Vol 10 (7) ◽

pp. e038042

Author(s):

Thomas A Meijers ◽

Adel Aminian ◽

Koen Teeuwen ◽

Marleen van Wely ◽

Thomas Schmitz ◽

...

Keyword(s):

Percutaneous Coronary Intervention ◽

Vascular Complications ◽

Coronary Intervention ◽

Ethics Committee ◽

Bleeding Complications ◽

Access Site ◽

Femoral Access ◽

Coronary Syndrome ◽

Percutaneous Coronary ◽

Coronary Lesions

IntroductionThe radial artery has become the standard access site for percutaneous coronary intervention (PCI) in stable coronary artery disease and acute coronary syndrome, because of less access site related bleeding complications. Patients with complex coronary lesions are under-represented in randomised trials comparing radial with femoral access with regard to safety and efficacy. The femoral artery is currently the most applied access site in patients with complex coronary lesions, especially when large bore guiding catheters are required. With slender technology, transradial PCI may be increasingly applied in patients with complex coronary lesions when large bore guiding catheters are mandatory and might be a safer alternative as compared with the transfemoral approach.Methods and analysisA total of 388 patients undergoing complex PCI will be randomised to radial 7 French access with Terumo Glidesheath Slender (Terumo, Japan) or femoral 7 French access as comparator. The primary outcome is the incidence of the composite end point of clinically relevant access site related bleeding and/or vascular complications requiring intervention. Procedural success and major adverse cardiovascular events up to 1 month will also be compared between both groups.Ethics and disseminationEthical approval for the study was granted by the local Ethics Committee at each recruiting center (‘Medisch Ethische Toetsing Commissie Isala Zwolle’, ‘Commissie voor medische ethiek ZNA’, ‘Comité Medische Ethiek Ziekenhuis Oost-Limburg’, ‘Comité d’éthique CHU-Charleroi-ISPPC’, ‘Commission cantonale d'éthique de la recherche CCER-Republique et Canton de Geneve’, ‘Ethik Kommission de Ärztekammer Nordrhein’ and ‘Riverside Research Ethics Committee’). The trial outcomes will be published in peer-reviewed journals of the concerned literature.Trial registration numberNCT03846752.

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Post PCI Vascular and Bleeding Complications in Patients with or Without CKD

Indian Journal of Cardiovascular Disease in Women WINCARS ◽

10.1055/s-0038-1656471 ◽

2016 ◽

Vol 01 (01) ◽

pp. 022-027

Author(s):

Harish Oruganti ◽

Jyotsna Maddury

Keyword(s):

Renal Failure ◽

Kidney Diseases ◽

Vascular Complications ◽

Therapeutic Interventions ◽

Bleeding Complications ◽

Access Site ◽

Chronic Kidney Diseases ◽

Artery Disease ◽

General Populations ◽

Distal Embolisation

AbstractBACKGROUND: There is increasing trend of both Cardiovascular disease (CVD) and chronic kidney diseases (CKD) in general populations. The individuals with CKD are more likely to die of CVD than of kidney failure. Both diagnostic and therapeutic interventions are crucial in management of CKD patients with coronary artery disease. As CKD itself is associated with more bleeding complications we aim to study the incidence of vascular complications (vessel thrombosis, distal embolisation, dissection, poorly controlled bleeding at puncture site, pseudoaneurysm, arteriovenous fistula, retroperitoneal hematoma, and development of femoral neuropathy) in Percutaneous intervention (PCI) patients with renal failure.METHODS: 950 patients who underwent PCI procedures were classified into CKD (GFR<60ml/min/m2) (n=380, 40%) and non-CKD (n=570, 60%) groups. Two groups were analyzed for the occurrence of vascular complications post PCI.RESULTS: Vascular complications were seen in 28 out of 380 patients with CKD (7.37%) and 17 out of 570 patients without CKD (2.98%). Patients with renal failure (GFR<60ml/min/m2) were found to have higher risk of vascular complications post PCI. [p = 0.03, OR = 2.588 (1.344-5.017)]. Non access site complications were more common in patients with CKD compared to non CKD. 16 patients with CKD developed non access site complications compared to 9 in patients without CKD.[p=0.001, odds ratio 2.793(1.15-6.916)CONCLUSIONS: This study demonstrates higher risk of vascular complications post-PCI in patients with CKD compared to non CKD patients. Higher incidence of non access site complications was also observed in CKD patients.

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Bleeding complications at the access sites during catheter directed thrombolysis for acute limb ischaemia: Mini review

10.29328/journal.avm.1001014 ◽

2021 ◽

Vol 5 (1) ◽

pp. 001-003

Author(s):

Noory Elias ◽

Böhme Tanja ◽

Beschorner Ulrich ◽

Zeller Thomas

Keyword(s):

Treatment Options ◽

Limb Ischemia ◽

Lower Limbs ◽

Bleeding Complications ◽

Limb Ischaemia ◽

Acute Limb Ischemia ◽

Access Site ◽

Catheter Directed Thrombolysis ◽

Acute Limb Ischaemia ◽

Surgical Bypass

Acute and subacute ischemia of the lower limbs represents a major emergency with a high in-hospital mortality, complication, and leg amputation rates. Treatment options for acute limb ischemia include systemic anticoagulation, followed by various catheter based options including infusion of fibrinolytic agents (pharmacological thrombolysis), pharmacomechanical thrombolysis, catheter-mediated thrombus aspiration, mechanical thrombectomy, and any combination of the above or open surgical intervention (thromboembolectomy or surgical bypass). Minor and major bleeding complication during catheter directed thrombolysis (CDT) especially at access site are frequent. Bleeding complications require often an interruption or termination of CDT affecting clinical outcome of the patients. Recently we examined a new access site bleeding protection device during CDT.

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Outcome off Primary Coronary Angioplasty by Radial Route: Study on 100 Cases

International Journal of Innovative Research in Medical Science ◽

10.23958/ijirms/vol03-i06/06 ◽

2018 ◽

Vol 3 (06) ◽

Author(s):

Dr. Dilip Ratnani ◽

Dr. Rekha Ratnani

Keyword(s):

Hospital Stay ◽

Radial Artery ◽

Bleeding Complications ◽

Access Site ◽

Transfemoral Approach ◽

Artery Cannulation ◽

Catheterization Laboratory ◽

Cardiac Catheterization Laboratory ◽

Radial Access ◽

Coronary Procedures

Recently radial artery is being used as a vascular access route for coronary procedures. Primary angioplasty with transfemoral procedure is associated with high access site bleeding complications due to use of potent antiplatelets and anticoagulants therefore radial access should be preferred if the operators are experienced and familiar with the technique. Methods: Total 100 pa‡…tients were included in the study in which procedure was performed by the trans radial route. All routine laboratory investigations were performed. Support of a temporary pacemaker was kept ready. All patients were prepared according to the Cardiac Catheterization Laboratory Standards. Radial artery cannulation was performed. Results: 100 patients were included in the study selected for radial route. Mean age of the patients who underwent primary CAI was 59±8.4. The most affected artery in the as shown angiography was Left anterior descending (58%) followed by Right coronary artery (41%). Least affected artery was left main (6%) and Ramus intermedius (6%). Mean of diseased vessels was 1.34 ± 1.25. Crossover from radial to femoral route was done on 5 patients of which 2 patients were having radial artery anomaly and in 3 patients arterial puncture was not successful. Mean hospital stay of the patients after procedure was 6.8 ± 2.1. Conclusion: transradial approach for coronary procedures is a safe technique and gives similar clinical results to transfemoral access. Complications at the radial access site are negligible. Length of hospital stay, time to mobilisation and cost all are reduced in the transfemoral approach.

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Safety and efficacy of Mynx vascular closure device for the closure of common femoral artery access after ipsilateral stent placement

The Journal of Vascular Access ◽

10.1177/1129729820966946 ◽

2020 ◽

pp. 112972982096694

Author(s):

Jin Ho Hwang ◽

Sang Woo Park ◽

Woo Young Yang ◽

Yong Wonn Kwon ◽

Jeeyoung Min ◽

...

Keyword(s):

Femoral Artery ◽

Stent Placement ◽

Common Femoral Artery ◽

Bleeding Complications ◽

Closure Device ◽

Technical Failure ◽

Technical Success ◽

Vascular Closure Device ◽

Access Site ◽

Low Bmi

Introduction: To evaluate the feasibility and safety of the Mynx vascular closure device (VCD) for arteriotomy closure after stent placement near the common femoral artery (CFA) access site. Methods: A total of 88 patients (73 men; mean age, 72 ± 9.2 years; 136 procedures) who underwent closure of CFA arteriotomy using the Mynx VCD after stent placement in proximal superficial femoral artery (SFA) with antegrade approach, or in common or external iliac artery with retrograde approach were retrospectively studied. Technical success and access site complication were evaluated. Body mass index (BMI), platelet count, international normalized ratio, prior history of ipsilateral CFA access, access direction, degree of CFA calcification, stent location and diameter, total procedure time, and sheath size were analyzed to evaluate their relationship with technical failure and development of bleeding complications. Results: Technical success was achieved in 94.9% (129/136) patients. The mean time to hemostasis was 0.7 ± 1.8 min. Technical failure was significantly associated with low BMI ( p = 0.001). Other variables presented no significant relationship with technical failure and development of complications. Ultrasonography on the day after the procedure revealed that 8 (5.9%) patients had hematoma. Conclusions: Mynx VCD for arteriotomy closure is feasible and provides hemostatic safety after stent placement near antegrade or retrograde CFA access. However, Mynx VCD may have a poor technical success rate among patients with low BMI.

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Transulnar approach as an alternative to transradial approach in non-coronary intervention: safety, feasibility and technical factors

The Journal of Vascular Access ◽

10.5301/jva.5000691 ◽

2017 ◽

Vol 18 (3) ◽

pp. 250-254 ◽

Cited By ~ 3

Author(s):

Adam Zybulewski ◽

Martin Edwards ◽

Edward Kim ◽

Francis S. Nowakowski ◽

Rahul Patel ◽

...

Keyword(s):

Radial Artery ◽

Coronary Intervention ◽

Artery Occlusion ◽

Effective Alternative ◽

Bleeding Complications ◽

Technical Success ◽

Internal Radiation ◽

Access Site ◽

Technical Factors ◽

Liver Embolization

Purpose Transulnar access (TUA) has been shown to be an effective alternative to transradial access (TRA) for coronary intervention. This study evaluates the safety and efficacy of TUA in patients undergoing visceral interventions in the setting of contraindication to TRA. Materials and Methods Patients who underwent visceral interventions via ulnar approach were included in the study. Outcome variables include technical success, access site and bleeding complications. Results From May 2014 to September 2016, TUA was attempted 17 times in 14 patients (mean age: 60 years; range: 27 to 81 years) for whom TRA was planned for visceral intervention, but contraindicated. Contraindication to TRA included Barbeau D waveform (n = 3), radial artery diameter <2 mm (n = 8), known radial loop (n = 2), high takeoff of the radial artery (n = 2), prior radial artery occlusion (RAO) (n = 1), and radiocephalic arteriovenous fistula (n = 1). Interventions included selective internal radiation therapy (SIRT) (n = 4), SIRT mapping (n = 2), chemoembolization (n = 6), renal embolization (n = 1) and bland liver embolization (n = 4). Technical success was achieved in 94.1% (16/17 cases) with the single failure attributed to an inability to cannulate the target vessel due to vessel tortuosity, requiring ipsilateral femoral crossover. There were no major access site or bleeding complications. Minor adverse events include two access site hematomas, which were successfully treated with conservative management. Conclusions TUA for visceral interventions is a safe and effective alternative to femoral approach when TRA is contraindicated.

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Ultrasound- Versus Fluoroscopy-Guided Strategy for Transfemoral Transcatheter Aortic Valve Replacement Access: A Systematic Review and Meta-Analysis

Circulation Cardiovascular Interventions ◽

10.1161/circinterventions.121.010742 ◽

2021 ◽

Author(s):

Rafail A. Kotronias ◽

Jonathan J.H. Bray ◽

Skanda Rajasundaram ◽

Flavien Vincent ◽

Cedric Delhaye ◽

...

Keyword(s):

Systematic Review ◽

Transcatheter Aortic Valve Replacement ◽

Ultrasound Guidance ◽

Meta Analysis ◽

Vascular Complications ◽

Bleeding Complications ◽

Ultrasound Guided ◽

Access Site ◽

Transcatheter Aortic Valve ◽

Life Threatening

Background: Access site vascular and bleeding complications remain problematic for patients undergoing transcatheter aortic valve replacement (TAVR). Ultrasound-guided transfemoral access approach has been suggested as a technique to reduce access site complications, but there is wide variation in adoption in TAVR. We performed a systematic review and meta-analysis to compare access site vascular and bleeding complications according to the Valve Academic Research Consortium-2 classification following the use of either ultrasound- or conventional fluoroscopy-guided transfemoral TAVR access. Methods: Medline, Embase, Web of Science, and The Cochrane Library were searched to November 2020 for studies comparing ultrasound- and fluoroscopy-guided access for transfemoral TAVR. A priori defined primary outcomes were extracted: (1) major, (2) minor, and (3) major and minor (total) access site vascular complications and (4) life-threatening/major, (5) minor, and (6) life-threatening, major, and minor (total) access site bleeding complications. Results: Eight observational studies (n=3875) were included, with a mean participant age of 82.8 years, STS score 5.81, and peripheral vascular disease in 23.5%. An ultrasound-guided approach was significantly associated with a reduced risk of total (Mantel-Haenszel odds ratio [MH-OR], 0.50 [95% CI, 0.35–0.73]), major (MH-OR, 0.51 [95% CI, 0.35–0.74]), and minor (MH-OR, 0.59 [95% CI, 0.38–0.91]) access site vascular complications. Ultrasound guidance was also significantly associated with total access site bleeding complications (MH-OR, 0.59 [95% CI, 0.39–0.90]). The association remained significant in sensitivity analyses of maximally adjusted minor and total vascular access site complications (MH-OR, 0.51 [95% CI, 0.29–0.90]; MH-OR, 0.44 [95% CI, 0.20–0.99], respectively). Conclusions: In the absence of randomized studies, our data suggests a potential benefit for ultrasound guidance to obtain percutaneous femoral access in TAVR. REGISTRATION: URL: https://www.crd.york.ac.uk/PROSPERO/ ; Unique identifier: CRD42020218259.

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Angiography catheter based bleeding complication at the access site related to Neurofibromatosis I

VASA ◽

10.1024/0301-1526/a000061 ◽

2010 ◽

Vol 39 (4) ◽

pp. 349-352

Author(s):

Gorny ◽

Mildner ◽

Fraedrich ◽

Greiner

Keyword(s):

Neurofibromatosis Type ◽

Percutaneous Transluminal Coronary Angioplasty ◽

Sole Source ◽

Bleeding Complications ◽

Type I ◽

Access Site ◽

Excessive Bleeding ◽

Arterial Access ◽

Neurofibromatosis I ◽

Transluminal Coronary Angioplasty

Neurofibromatosis Type I (NF-I) is one of the most common inherited human diseases with an incidence of 1/3000. Besides the cardinal features, all organs or body structures as well as several arterial regions can occasionly be affected. We present an unusual case of an access-site hematoma following percutaneous transluminal coronary angioplasty in a patient suffering from NF-1. After exposure of the vessels, excessive bleeding from surrounding proliferations of supposedly neurofibromatous or ganglioneuromatous tissue was identified as the sole source of the hematoma. Patients with neurofibromatosis are at considerable risk of obtaining catheter interventions over the years. In this group, we strongly recommend an ultrasound examination of the arterial segment where the arterial access is planned. In case of suspicious findings an alternative approach should be preferred to avoid bleeding complications.

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