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1.
Vasc Endovascular Surg ; : 15385744241276688, 2024 Aug 22.
Artículo en Inglés | MEDLINE | ID: mdl-39172918

RESUMEN

INTRODUCTION: Our retrospective study aimed at assessing safety of vascular closure devices (VCDs) used in a large single-centre Interventional Radiology (IR) department. Complication and deployment failure rates using collagen-based (Angio-seal) and suture-based (ProGlide) devices for common femoral artery haemostasis were compared. MATERIALS AND METHODS: Data from VCDs deployed over a 6-year period were retrospectively analysed for patient age, procedure indication, puncture mode (antegrade/retrograde), sheath size, deployment failure and complications (haematoma, pseudoaneurysm formation, limb occlusion). Numerical and statistical analysis was undertaken. RESULTS: Overall, 1321 common femoral artery punctures in 1217 patients were closed using VCDs. Failure rate using ProGlide was significantly higher when compared with Angio-seal (P=<0.001) in sheath sizes ≤8 Fr. Heparin was not administered in embolisation procedures compared with angioplasty with or without stenting. Therefore, haematoma tended to occur more frequently following angioplasty without stenting (P = 0.003) and angioplasty with stenting (P = 0.001), when compared with embolisation. Deployment failure occurred more frequently when heparin was used during the procedure (P = 0.005). CONCLUSION: Although complications relating to sheath size are well established in the literature, there remains a paucity of data assessing the impact of procedure specific factors when comparing VCDs. Our study challenges that size is the sole determinant of VCD success and invites a more holistic view of VCD deployment strategies. This study advocates continued research into the nuances of other potential confounding variables to optimise patient outcomes.

2.
J Soc Cardiovasc Angiogr Interv ; 3(6): 101929, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-39132601

RESUMEN

Background: Hemostasis for transfemoral transcatheter aortic valve replacement (TAVR) is typically achieved using a suture-mediated vascular closure device (VCD) prior to large-bore sheath insertion (preclosure technique). Recently, the addition of a hybrid closure technique using a preclose technique with the addition of a collagen-plug VCD after sheath removal in cases of failed hemostasis has been utilized. Methods: Data were collected from the Northwell TAVR registry, including 3 high-volume TAVR centers. We evaluated a preclose strategy with suture-mediated vascular closure alone ("legacy strategy") and standard bailout techniques versus a contemporary hybrid strategy of suture-mediated closure with collagen-mediated closure bailout. The primary end point was major or minor vascular complications as defined by the VARC-3 criteria. Results: A total of 1327 patients were included, of which 791 patients underwent TAVR with suture-mediated closure alone and 536 with contemporary strategy. The primary end point (major or minor vascular complication) was lower in the contemporary strategy (5.44% vs 1.31%; P < .001). Both minor (3.92% vs 1.12%; P = .002) and major (1.14% vs 0.19%; P = .0196) vascular complications were reduced and the total length of stay was less in the contemporary strategy (median of 3 days vs 2 days; P < .0001). Using multivariable analysis, we observed that vascular management strategy significantly improved the composite primary outcome when adjusted for sheath size, peripheral artery disease, carotid disease, and site of procedure. In the contemporary group, bailout collagen-plug VCD with an Angio-Seal (Terumo Medical) was used in 68 patients (12.69%) and bailout MANTA (Teleflex) was required in 4 patients (0.75%). There were no major or minor vascular complications among the patients who received bailout collagen-plug VCD. Conclusions: A contemporary hybrid strategy of suture-mediated closure with collagen-mediated closure bailout reduces the risk of vascular complications among patients undergoing transfemoral TAVR.

3.
J Endovasc Ther ; : 15266028241266182, 2024 Jul 31.
Artículo en Inglés | MEDLINE | ID: mdl-39082670

RESUMEN

PURPOSE: This single-center study aimed to assess patients who underwent intentional percutaneous endovascular aortic aneurysm repair (pEVAR) with Hybrid Technique combining a single Perclose (Abbott, Abbott Park, Illinois) Suture-Mediated Closure Device + single Angio-Seal VIP 8F (Terumo, Tokyo, Japan) and compare outcomes with the standard Dual Perclose technique. Materials and Methods: Consecutive elective pEVAR patients treated from November 2022 to November 2023, with healthy femoral accesses and introducer sheaths ≤20 French (F) outer diameter, were included. Coin-toss randomization determined whether a combination of single Perclose Device + single Angio-Seal VIP 8F (Hybrid Technique) or the standard double Perclose Devices (Dual Perclose) was used. In Hybrid Technique, a single Perclose device was positioned at 12 o'clock; a single Angio-Seal VIP 8F was placed after sheaths removal. Dual Perclose followed standard procedure. Primary endpoints included immediate hemostasis, sheath diameter differences, access conversion rate, technical success, and cost analysis. RESULTS: The study involved 60 pEVAR patients (median age=78, interquartile range [IQR]=72-85 years) within the inclusion criteria. In 14 (24%) cases, only 1 femoral access was studied. There were 106 pEVAR accesses, with 58 (54.7%) in the Hybrid Technique group and 48 (45.3%) in the Dual Perclose group. Both groups exhibited homogeneity in pre-operative characteristics and sheath diameter (Hybrid Technique-16F vs Dual Perclose-18F; p=0.202). Immediate hemostasis was achieved in 100% of the Hybrid Technique group vs 87.5% for the Dual Perclose group (p=0.006). Surgical access conversion was unnecessary. Technical success was 100%, with all 6 femoral bleeding cases after Dual Perclose resolved endovascularly, using additional devices. Cost analysis showed a median cost of 330 euros (IQR=0) for the Hybrid Technique group vs 384 euros (IQR=360-456) for the Dual Perclose group (p<0.001). Thirty-day mortality was 3%, in 2 fragile patients, without access-related complications. Multivariate analysis identified Dual Perclose access (odds ratio [OR]=35.6; 95% confidence interval [CI]=18.3-36.8; p<0.001) and obesity (OR=19.7; 95% CI=1.4-23.9.5; p<0.001) as independent risk factors for immediate hemostasis failure. Median follow-up was 134 days (IQR=41-227), with 1 Hybrid Technique case (2%) successfully treated with thrombin injection for a small femoral pseudoaneurysm after 62 days. CONCLUSIONS: The elective Hybrid Technique with combination of single Perclose Device + single Angio-Seal VIP 8F during pEVAR in selected patients appears to be non-inferior to the standard Dual Perclose procedure. It demonstrates a positive trend in reducing immediate hemostasis failure and costs. Both procedures achieved technical success and avoiding surgical access conversions. CLINICAL IMPACT: This study introduces a novel elective hybrid technique combining a single Perclose device with a single Angio-Seal VIP 8Fr for percutaneous endovascular abdominal aortic interventions. Results for hybrid technique showed 100% technical success and efficient immediate hemostasis, while costing less than standard dual Perclose procedure. Both procedures did not require surgical conversions. Despite being a single-center study, it demonstrates potential benefits of the intentional application of this hybrid technique towards minimally invasiveness. Obesity and dual Perclose technique were identified as independent risk factors for hemostasis failure, reaffirming the hybrid technique procedure's efficacy as well as and non-inferiority to standard procedure.

4.
Eur Heart J Case Rep ; 8(2): ytae060, 2024 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-38374984

RESUMEN

Background: Patients requiring coronary intervention after acute myocardial infarction, with decompensated heart failure and multiple co-morbidities, present a challenging clinical scenario. Addressing such high-risk cases has been a marked increase in the simultaneous support using microaxial flow pump devices, providing a crucial haemodynamic support during procedures. Case summary: We report the case of a 58-year-old man, with a non-ST-segment elevation myocardial infarction in the context of a peripheral vascular surgery. Echocardiography revealed severely reduced left ventricular function and cardiac magnetic resonance imaging demonstrated transmural scars in all but left anterior descending artery area. The patient was of extreme high surgical risk due to the multiple co-morbidities, acute decompensation heart failure, and peripheral artery disease, and, therefore, the heart team preferred protected percutaneous coronary intervention (PCI) over coronary artery bypass graft for revascularization. The peripheral artery disease included severely calcified ascending aorta, occlusions of both femoral arteries, the left subclavian artery, and the right radial artery. Taken together, the heart team agreed on a hybrid approach with surgical implantation of Impella 5.0 via the left subclavian artery, by a single-access technique. Following the intervention procedure, haemostasis of the vascular prosthesis was achieved by an angio-seal technique without complications. The patient recovered satisfactorily, with improved left ventricular function, and discharged 10 days post-procedure. Discussion: The single-access high-risk PCI technique offers a standardized approach for microaxial flow pump devices such as Impella 5.0 and PCI. The subclavian artery as a single-access route for high-risk PCI has demonstrated safety and efficacy.

5.
J Endovasc Ther ; : 15266028231219226, 2023 Dec 18.
Artículo en Inglés | MEDLINE | ID: mdl-38110358

RESUMEN

PURPOSE: Angio-Seal (Terumo Medical Corporations, Somerset, New Jersey) device is indicated for femoral arteriotomy closure. Real-world published data on complications are limited. We present 1 year of safety events involving Angio-Seal from the US Food and Drug Administration's post-market surveillance database of Manufacturer and User Facility Device Experience (MAUDE). Steps for managing frequent device-related problems are discussed. MATERIALS AND METHODS: Angio-Seal MAUDE data from November 2019 to December 2020 was classified according to (1) mode of device failure, (2) complication, (3) treatment, and (4) Cardiovascular and Interventional Radiological Society of Europe (CIRSE) adverse event classification system. RESULTS: There were 715 safety events, involving Angio-Seal VIP (93.1%), Evolution (5.7%), STS Plus (1.1%), and sizes 6F (62.5%) and 8F (37.5%). Failure mode involved unrecognized use of a damaged device (43.4%), failed deployment (20.1%), failed arterial advancement (6.3%), detachment of device component (4.9%), failed retraction (3.6%), operator error (1.1%), and indeterminate (20.6%). Of total, 44.8% of events were associated with patient harm. Complications involved minor blood loss (34.1%), hematoma (5.6%), significant blood loss (1.4%), and pseudoaneurysm (1.4%). Of total, 43.3% of cases required manual compression (MC), whereas 8.8% required more advanced intervention. Interventions included surgical repair (49.2%), thrombin injection (9.5%), balloon tamponade (6.3%), covered stent (4.8%), and unspecified (30.2%). Majority of safety events were CIRSE grade 1 (92.0%), followed by grades 2 (3.1%), 3 (4.6%), and 6 (deaths, 0.3%). Minority of devices were returned for manufacturer analysis (27.8%). CONCLUSIONS: The majority of safety events were associated with minor blood loss or local hematoma and could be addressed with MC alone. Most events were attributed to damaged device; however, very few devices were returned to manufacturer for analysis. This should be encouraged to allow for root cause analysis in order to improve safety profile of devices. System-level strategies for addressing barriers to under-reporting of safety events may also be considered. CLINICAL IMPACT: Our study highlights important safety events encountered in real-world practice with Angio-Seal closure device. The MAUDE database captures real-world device malfunctions not typically appreciated in conventional clinical trials. Our study provides valuable insight for clinician-users on anticipating and managing the most common device malfunctions. Additionally, our data provide feedback for manufactures to optimize product design and direct manufacturer user training to improve safety. Finally, we hope that the study promotes system-level strategies that foster reporting of safety events and undertaking of root cause analysis.

6.
J Clin Imaging Sci ; 13: 26, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37810184

RESUMEN

Vascular closure devices (VCDs) are being increasingly used for achieving hemostasis after diagnostic and therapeutic endovascular procedures. Although uncommon, complications may be encountered which are associated with the use of these VCDs. We report four cases where the use of Angio-Seal (Terumo, Somerset, New Jersey, USA) was followed by complications. Three cases presented with acute limb ischemia, among them, two patients had arterial occlusion at the vascular access site and one patient had embolization of the footplate anchor of the closure device. One case presented with pseudoaneurysm at the common femoral artery access site along with occlusion at origin of the superficial femoral artery. We have described the mechanism in which these complications occur and the successful management of these cases preventing potential amputation and limb loss. The risk factors which increase the risk of complications with the use of Angio-Seal VCD were reviewed and the strategy to avoid these complications with particular emphasis on the utility of ultrasound when using Angio-Seal VCD is discussed. A strategy to manage these complications has been discussed while deciding on endovascular management or surgical management, especially in patients with challenging presentation and those with multiple comorbidities making them at very high risk for surgery.

7.
Cardiovasc Intervent Radiol ; 46(2): 268-273, 2023 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-36526800

RESUMEN

PURPOSE: Pseudoaneurysm (PSA) developing after catheter examinations is one of the most frequent vascular complications and a nonsurgical technique with utmost low risk of complications is warranted. Our aim was to investigate the technical feasibility, success, and safety of transaneurysmal occlusion of complicated post-interventional common femoral artery (CFA) PSA using the Angio-Seal Closure Device (ASCD) and a technique that we describe as the transaneurysmal (TA) maneuver. MATERIAL AND METHODS: We used the Angio-Seal (Terumo, Tokyo, Japan) Closure System to manage complicated PSAs in patients who would otherwise have needed surgery after failure of all conservative therapies. The TA maneuver was performed in 14 consecutive patients from July 2021 to July 2022. After ultrasound-guided puncture of the PSA close to its neck, the CFA was entered radiographically with micro-guidewires, and the neck of the PSA was closed with the ASCD after changing the sheaths and wires. All patient had to wear a pressure dressing until the next day, when successful closure was verified by sonography. RESULTS: All procedures were performed with technical success and without any complications. No patient had to undergo surgery. All sonographies on the next day confirmed complete absence of perfusion within the PSA and normal flow conditions of the CFA and vessels below. CONCLUSION: The TA maneuver a promising minimally invasive procedure for closing complicated PSA of the CFA after catheter examination.


Asunto(s)
Aneurisma Falso , Humanos , Aneurisma Falso/diagnóstico por imagen , Aneurisma Falso/terapia , Arteria Femoral/diagnóstico por imagen , Arteria Femoral/cirugía , Técnicas Hemostáticas , Punciones , Japón , Resultado del Tratamiento
8.
Animals (Basel) ; 12(12)2022 Jun 07.
Artículo en Inglés | MEDLINE | ID: mdl-35739818

RESUMEN

Background: There are different indications for endovascular surgery in horses, mainly the treatment of guttural pouch mycosis. Traditionally, these procedures are carried out by open arteriotomy of the common carotid artery (CCA), although less invasive percutaneous ultrasound-guided carotid access (PUGCA) has been described in experimental horses. In human medicine, commercial closure systems are used to seal these arterial puncture sites and reduce complications. The aims of this study are to retrospectively describe our experience with PUGCA in clinical cases and to report, for the first time, the use of the commercial vascular closure device Angio-Seal after PUGCA in horses. Methods: Retrospective study of clinical case records. Collected parameters, including the feasibility of the PUGCA and variables related to the safety and efficacy of the use of the Angio-Seal. Results: Twelve PUGCA procedures in 11 horses were included. In all cases, the artery was effectively accessed, and the planned procedure could be performed. In two cases, haematoma/bleeding due to incorrect use of the Angio-Seal was recorded. This complication rate (16.66%) was lower than that obtained in other studies using PUGCA in horses, but where the puncture was sealed by manual compression only. Main limitations: A control group of clinical cases with PUGCA but without using Angio-Seal is not available. Conclusions: Clinical data confirm previous experimental results, which showed that PUGCA is safe and effective in horses. The Angio-Seal system, regardless of possible complications due to incorrect use, can be used safely and effectively in horses. Further studies comparing arterial access site management using manual compression or Angio-Seal would be necessary to state if its routine use in horses is advisable.

9.
Clin Case Rep ; 9(12): e05170, 2021 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-34917378

RESUMEN

Vascular complications (VCs) remain an important source of morbidity and mortality following percutaneous arterial catheterization. Vascular closure devices are popular and frequently used, but sometimes cause vessel occlusions that may require vascular surgery or complex endovascular procedures. In this case report, we describe the endovascular retrieval of an embolized Angio-Seal device causing acute limb ischemia in a severely diseased 75-year-old female patient. This case highlights the endovascular technique using a snare catheter and adds another example to the growing evidence of an endovascular approach to manage vascular access site complications in comorbid patients at risk.

10.
SAGE Open Med Case Rep ; 9: 2050313X211004818, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-33854782

RESUMEN

A 76-year-old man who had undergone percutaneous coronary intervention suffered intermittent claudication. Duplex ultrasonography revealed superficial femoral artery stenosis with an intraluminal heterogeneous echogenic mass. We suspected that stenosis was caused by the puncture procedure of the Angio-Seal. Open surgery revealed that a collagen sponge that should have been outside the arterial wall was misplaced in the wall with massive granulation, and atherectomy with patchplasty was performed. Vessel deterioration was considered due to several factors, including inappropriate access site, arterial wall calcification, and comorbidities like Behçet's disease. Ultrasonography is a convenient and useful method to evaluate arterial lesions.

12.
Interv Neuroradiol ; 27(5): 703-711, 2021 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-33601976

RESUMEN

INTRODUCTION: Angio-Seal is a commonly used device for femoral hemostasis in neuroendovascular procedures. This meta-analysis investigates of the safety and efficacy of Angio-Seal in patients undergoing endovascular neurointerventional procedures. METHODS: A systematic review and meta-analysis on all studies evaluating the Angio-Seal device in neurointerventional procedures from inception through 2020 were performed. We studied rates of groin hematoma, retroperitoneal hematoma, pseudoaneurysm, ipsilateral DVT, and ischemic complications. Meta-analysis was performed using the random-effects model. RESULTS: 13 studies were included in our analysis. 2250 patients with 104 complications were found {4.5% (95% CI, 2.7%-6.3%)}. Of these complications, groin hematoma was the most common with a rate of 2.4% (95% CI, 1.1%-3.6%). Retroperitoneal hematoma {0.3% (95% CI, 0%-0.5%)}, pseudo-aneurysm {0.5% (95% CI, 0.2%-0.8%), and ipsilateral DVT {0.3% (95% CI, 0.1%-0.7%) were also not in negligible rate. The rate of other complications were as follows: vessel occlusion/stenosis; 0.2% (95% CI, 0%-0.4%), vascular surgery; 0.2% (95% CI, 0%-0.5%), and infection; 0.2% (95% CI, 0%-0.5%). One patient died as result of hemorrhagic complications {0.1% (95% CI, 0%-0.3%)}. Use of anticoagulant/antiplatelet therapy was found to be positively correlated with high risk of any groin complication and groin hematoma (p ≤ .05). Female gender was associated with high risk of ipsilateral DVT (p ≤ .05). Interestingly, large sheath size was associated with low risk of groin hematoma (p ≤ .05). CONCLUSION: The safety and efficacy rate of Angio-Seal was approximately 95%. The most common complication was groin hematoma. Serious complications including retroperitoneal hematoma and femoral artery occlusion were rare.


Asunto(s)
Procedimientos Endovasculares , Técnicas Hemostáticas , Procedimientos Endovasculares/efectos adversos , Femenino , Arteria Femoral , Humanos , Isquemia , Punciones , Resultado del Tratamiento
13.
Eur Heart J Case Rep ; 4(5): 1-4, 2020 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-33204948

RESUMEN

BACKGROUND: Iatrogenic perforation of the right ventricle (RV) is a rare but recognized complication of pericardiocentesis. Treatment strategies for RV perforation include surgical repair and percutaneous closure. In this case report, we describe the use of an angio-seal vascular closure device (Terumo Interventional Systems) to seal an iatrogenic RV perforation secondary to incorrect placement of a pericardial drain. CASE SUMMARY: A 55-year-old female presented with an anterior ST-elevation myocardial infarction. Coronary angiography demonstrated occlusion of the left anterior descending artery. The patient went on to have primary percutaneous coronary intervention and both the left anterior descending and D1 were wired. During kissing balloon inflation, the Sion Blue wire migrated distally in the D1 causing an Ellis type 3 wire tip perforation in the distal D1. Emergency pericardiocentesis was performed however the 8 French (8 Fr) pericardial drain was inadvertently inserted into the RV. It was decided to attempt percutaneous closure with an 8 Fr angio-seal in the catheter lab under echocardiographic and fluoroscopic guidance. Our patient did not demonstrate any recurrence of pericardial effusion on repeat echocardiography over 60 days post-procedure. DISCUSSION: Our patient did not demonstrate any recurrence of pericardial effusion on repeat echocardiography over 60 days post-procedure. We feel that the angio-seal vascular closure device represents an effective, minimally invasive treatment for this rare but potentially catastrophic complication of pericardiocentesis. In this case, the technique spared our patient a sternotomy with its associated morbidity.

14.
J Clin Neurosci ; 74: 61-64, 2020 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-32001109

RESUMEN

Various adjunctive techniques for neurointerventional procedures require a large-bore sheath introducer, but there is concern that this could result in more puncture site hemorrhagic complications despite using a vascular closure device. The purpose of this study was to assess the relationship between use of large-bore sheath introducer and post-procedural complications. Between January 2016 and April 2018, 126 neurointerventional procedures were performed in our hospital using 8 or 9 Fr sheath introducer in size and the Angio-Seal STS PLUS (St. Jude Medical, Minnetonka, USA). Hemorrhagic complications were defined as obvious swelling or bleeding at the puncture site or as extravascular bleeding detected by ultrasonography or contrast-enhanced computed tomography. The procedures were divided into a group with post-puncture bleeding (group B, n = 21) and a group without bleeding (group N, n = 105). Risk factors were compared between the groups according to the incidence of post-puncture bleeding. In addition, we assessed the outcome and approach to hemostasis in the procedures with bleeding. In result, hemorrhagic complications occurred in 21 procedures (17%), and pseudoaneurysm was detected in 4 procedures (3.2%). In 20 of group B (16%), manual compression was performed for an average of 36.4 min. One patient (0.79%) required surgical angioplasty. Risk factors for bleeding were not significantly different between the two groups. None of the patients with bleeding showed a decrease on the modified Rankin Scale. In conclusion, use of a large-bore sheath introducer may increase the incidence of post-puncture bleeding, but the outcome of this complication is acceptable.


Asunto(s)
Hemorragia/etiología , Punciones/efectos adversos , Adulto , Anciano , Angioplastia , Femenino , Hemorragia/terapia , Hemostasis , Técnicas Hemostáticas , Humanos , Masculino , Persona de Mediana Edad , Punciones/instrumentación , Factores de Riesgo
15.
J Neuroendovasc Ther ; 14(2): 48-55, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-37502456

RESUMEN

Objective: To retrospectively analyze the complication rates and risk factors associated with the use of the Angio-Seal vascular closure device during neuroendovascular therapy. Methods: In this study, we enrolled 283 patients who underwent Angio-Seal hemostasis between December 2005 and June 2019 at our institute. We retrospectively analyzed the major and minor complication rates and risk factors between the complication and no-complication groups using the medical charts of patients for whom the device was used. Results: Of the 283 patients, 5 had major complications (1.8%) and 18 had minor complications (6.3%). There were no significant differences between the complication (n = 23) and no-complication (n = 260) groups regarding the baseline characteristics or operation procedures. Among the major complications, superficial femoral artery puncture, 8Fr device, Angio-Seal Evolution, post-carotid artery stenting, dual antiplatelet therapy, and delirium were considered risk factors. Conclusion: The Angio-Seal is a safe and useful hemostatic device. However, puncture site complications need to be considered when the device is used for contraindicated patients or for those with delirium who cannot rest following the procedure.

16.
Indian J Radiol Imaging ; 29(2): 211-214, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-31367094

RESUMEN

Iatrogenic common femoral artery pseudoaneurysm is a well-known vascular access complication of angiography and transfemoral intervention. Thrombin injection is a well-accepted technique in treating these pseudoaneurysms but possess a significant risk of distal lower extremity thrombosis leading to severe consequences. Several case reports described the novel approach to closing these pseudoaneurysms via a retrograde deployment of an Angio-Seal vascular closure device. We describe a case of a successful treatment of refractory iatrogenic femoral artery pseudoaneurysm using Amplatzer vascular plugs following unsuccessful retrograde deployment of an Angio-Seal vascular closure device.

17.
Pediatr Radiol ; 49(9): 1217-1221, 2019 08.
Artículo en Inglés | MEDLINE | ID: mdl-31190109

RESUMEN

BACKGROUND: The use of arterial closure devices in achieving femoral hemostasis has been well documented in adults but insufficiently studied in the pediatric population. An earlier study from our institution of 40 Angio-Seal devices in 38 patients concluded that the arterial closure device is safe in children with only a single minor complication. Ongoing experience with this device at our institution, however, suggests a higher rate of complication. OBJECTIVE: To retrospectively evaluate the safety and efficacy of the Angio-Seal in a pediatric population. MATERIALS AND METHODS: A retrospective analysis reviewed all cases in which the Angio-Seal was deployed from June 2011 to September 2017. Peri-procedural documentation was reviewed for pre-procedure labs, clinical effectiveness in achieving hemostasis and complications related to the use of this device. Logistic regression analysis was also used to evaluate the relationship between patient demographic, vessel size and indication for angiography, and the presence or absence of complications. RESULTS: During the study period, 48 additional Angio-Seal devices were deployed in 41 consecutive patients. Five patients were excluded for being older than 18 years. The mean age of the patients was 13.3 years (range: 4-18 years) with 18 patients female. The mean common femoral artery diameter was 5.98 mm in short axis diameter (range: 4-9 mm). Complications were present in 6/43 cases (14%) including 3 minor and 3 major complications that included additional procedures. No significant relationship was identified between vessel size, age and the indication for angiography, and the rate of complication on logistic regression analysis. CONCLUSION: While percutaneous arterial closure devices can be efficacious for achieving hemostasis, our experience demonstrates a higher rate of complications in children, contrary to a previous report. The deployment of such devices should be performed with prejudice in this population.


Asunto(s)
Arteria Femoral/cirugía , Hemostasis Quirúrgica/instrumentación , Adolescente , Angiografía , Niño , Preescolar , Femenino , Humanos , Masculino , Punciones , Estudios Retrospectivos
18.
Proc (Bayl Univ Med Cent) ; 32(1): 34-36, 2019 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-30956577

RESUMEN

Adequate and reliable hemostasis following transcatheter aortic valve implantation (TAVI) is crucial. Closure devices have improved the amount of time required to achieve hemostasis following these procedures. We retrospectively looked at TAVI procedures that achieved adequate hemostasis after use of the Angio-Seal as an adjunctive measure following use of the Perclose ProGlide system. Sixteen cases (age range, 56-91 years) were identified between January 2016 and February 2018. Half had undergone transfemoral diagnostic angiography in the same vessel used for the TAVI delivery system within the prior 1 to 63 days. Five were receiving oral anticoagulants; six, aspirin; and two, dual-antiplatelet therapy. All had undergone computed tomography angiography for sizing of iliofemoral arteries, aorta, and the aortic valve prior to TAVI. No patient experienced any significant access site-related complications or ischemic leg symptoms, and there were no reports of late vascular or access site complications. Our case series suggests that adjunctive Angio-Seal systems may be a reliable alternative for incomplete hemostasis following Perclose ProGlide systems and can serve as a "bailout" procedure for incomplete postprocedural hemostasis.

19.
Clin Med Insights Case Rep ; 12: 1179547619828714, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-30792582

RESUMEN

INTRODUCTION: Vascular closure devices are commonly used to achieve rapid haemostasis and early ambulation following arterial puncture for endovascular procedures. Although device failure rates are low, the consequences of arterial occlusion include severe limb ischaemia. We describe a novel endovascular technique for the treatment of Angio-Seal arterial closure device (Terumo, Europe NV) failure causing femoral artery occlusion. MATERIALS AND METHODS: We describe 2 cases of lower limb angioplasty performed for critical limb ischaemia where the access site was closed using an Angio-Seal according to the manufacturer instructions for use (IFU). In both cases, however, ultrasound could not be used during deployment of the Angio-Seal due to body habitus and small subcutaneous haematoma. In both cases, the device failed and occluded the femoral artery. RESULTS: Access was achieved via a retrograde approach from the contralateral limb in one case and a retrograde approach from the ipsilateral profunda artery in the other case. Angiography confirmed that the footplate of the Angio-Seal had occluded the femoral artery. Subsequently, the occlusion was crossed and a short balloon-mounted bare metal stent placed to push the footplate against the arterial wall that resulted in resolution of the occlusion and haemorrhage control. CONCLUSIONS: Crossing the occlusion caused by failure of the Angio-Seal closure device and subsequent stenting resulted in satisfactory relief of the femoral artery occlusion and haemostasis without the added risks of open surgical revascularisation and general anaesthetic.

20.
J Vasc Surg Cases Innov Tech ; 5(1): 38-40, 2019 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-30740578

RESUMEN

Pseudoaneurysm was caused at the puncture site of the left groin after percutaneous coronary intervention. Balloon tamponade was attempted for hemostasis at the aneurysmal site. However, hemostasis was not achieved. Next, direct puncture of the pseudoaneurysm was tried. A 0.014-inch guidewire was crossed from the neck of the pseudoaneurysm to the left common femoral artery. The wire was replaced with a 0.035-inch guidewire. An 8F Angio-Seal (Terumo Interventional Systems, Somerset, NJ) was inserted, and a collagen plug was deployed at the neck of the pseudoaneurysm. Final angiography revealed completion of hemostasis. Three-dimensional computed tomography angiography after 8 months revealed no evidence of recurrence.

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