Vessel Closure Research Articles

Anastomoses in the Common Femoral Artery, Vascular Clips or Sutures? A Feasibility Study

The Vessel Closure System (VCS) is commercially available since 1997. This clip system has proven to be successful for vascular anastomoses in access surgery. There is little experience with the VCS in peripheral vascular surgery. A trial was conducted for patients with peripheral arterial disease, who required either a femoral artery endarterectomy or a peripheral bypass procedure. Patients were randomized into two groups: a VCS group, in which the proximal anastomoses were made using VCS clips; and a control group, in which both proximal and distal anastomoses were performed using Prolene sutures. Outcomes assessed were the speed of anastomosis and patency. Adverse events were monitored. In the VCS group, 12 patients underwent anastomoses using VCS clips. In the control group, 12 patients underwent vascular reconstruction using sutures. In the VCS group, the mean speed of anastomosis was 1.9 mm/min, whereas the mean speed in the control group was 2.5 mm/min; this was not significantly different (P = 0.096). After a follow-up of 12 months, there was no difference in patency. In the VSC group, two serious adverse events occurred, which required emergency surgery. Anastomosis in the femoral artery using VCS clips is not faster than that using running Prolene sutures, and in our small sample, two serious adverse events in the VCS group were observed. These results do not support the further use of vascular clips in peripheral vascular surgery.

Fondaparinux em intervenção coronária percutânea no tratamento da síndrome coronária aguda

Fondaparinux in Percutaneous Coronary Intervention for the Treatment of Acute Coronary Syndrome Background: Fondaparinux is considered an agent with a well­established safety and efficacy profile in the treatment of non­ST segment elevation acute coronary syndromes, but when used alone, is associated to a higher incidence of thrombotic com plications during invasive coronary procedures, requiring the supplementation of an anti­IIa agent. This study aimed to evaluate the efficacy and safety of percutaneous coronary in tervention (PCI) in patients with non­ST segment elevation acute coronary syndromes previously treated with fondapari­ nux. Methods: Prospective, controlled registry enrolling 127 consecutive patients submitted to an early invasive stratification during treatment with fondaparinux, with supplementation of intravenous unfractionated heparin at a dose of 85 U/kg at the time of PCI. Results: The rate of the composite primary end point including death, acute myocardial infarction, stroke, stent thrombosis or emergency myocardial revascularization was 3.2%. The cumulative incidence of major bleeding and vascular complications was 3.2%. There were no cases of gui de­ catheter thrombosis or abrupt vessel closure. Conclusions: PCI in patients with acute coronary syndromes receiving fondaparinux is associated with a low rate of major adverse cardiovascular ischemic events and severe hemorrhagic complications. Sup­ ple mentation of unfractionated heparin during the invasive procedures eliminates the risk of catheter­related thrombosis. DESCRIPTORS: Acute coronary syndrome. Angioplasty. Stents. Anticoagulants. Fondaparinux.

Intraprocedural Thrombotic Events During Percutaneous Coronary Intervention in Patients With Non–ST-Segment Elevation Acute Coronary Syndromes Are Associated With Adverse Outcomes: Analysis From the ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) Trial

The purpose of this study was to assess the prognostic impact of intraprocedural thrombotic events (IPTE) during percutaneous coronary intervention (PCI). Ischemic complications of PCI are infrequent but prognostically important. How often these events are a consequence of intraprocedural complications is unknown, with only limited data assessing the occurrence and importance of IPTE. A total of 3,428 patients who underwent PCI for non-ST-segment elevation acute coronary syndrome in the ACUITY (Acute Catheterization and Urgent Intervention Triage Strategy) trial underwent detailed frame-by-frame core laboratory angiographic analysis. An IPTE, defined as the development of new or increasing thrombus, abrupt vessel closure, no reflow, slow reflow, or distal embolization at any time during the procedure, occurred in 121 patients (3.5%). Patients with IPTE had higher in-hospital, 30-day, and 1-year major adverse cardiac event rates than patients without IPTE (25.6% vs. 6.3% in-hospital, 30.6% vs. 9.3% at 30 days, and 37.0% vs. 20.5% at 1 year; p < 0.0001 for each). An IPTE was strongly associated with Q-wave myocardial infarction and out-of-laboratory definite/probable stent thrombosis (in-hospital 3.3% vs. 0.5%, p = 0.006; 30 days 5.8% vs. 1.3%, p < 0.0001; and 1 year 6.7% vs. 2.0%, p = 0.0002). Unplanned revascularization, target vessel revascularization, and major bleeding not associated with coronary artery bypass graft surgery were also increased among patients with IPTE, as was overall 30-day mortality (3.3% vs. 0.7%, p = 0.002). Moreover, IPTE was an independent predictor of 30-day and 1-year composite death/myocardial infarction, stent thrombosis, and major adverse cardiac events. Although infrequent among patients undergoing early PCI for moderate and high-risk non-ST-segment elevation acute coronary syndrome, IPTE was strongly associated with subsequent adverse outcomes including death, myocardial infarction, and stent thrombosis.

Direct Percutaneous Access Technique for Transaxillary Transcatheter Aortic Valve Implantation: “The Hamburg Sankt Georg Approach”

This study questioned whether transaxillary transcatheter aortic valve implantation (TAVI) is feasible as a true percutaneous approach using percutaneous closure devices. Transaxillary TAVI is gaining increasing acceptance as an alternative to the transfemoral route; however, the access has always been done via surgical cutdown so far. Between August 2010 and September 2011, a total of 24 high-risk patients with severe aortic valvular stenosis underwent a percutaneous TAVI procedure by direct puncture of the axillary artery without surgical cutdown. For safety reasons and as a target for the puncture, a wire was advanced via the ipsilateral brachial artery. Moreover, a balloon was placed into the subclavian artery via the femoral artery for temporary vessel blockade before percutaneous vessel closure. Vascular closure was performed using either the ProStar XL system (Abbott Vascular Devices, Redwood City, California) or 2 ProGlide systems (Abbott Vascular Devices). The true percutaneous approach was successfully completed in all patients (14 left and 8 right axillary artery cases). Overall mortality at 30 days was 8.3%. Acute vascular closure device success was achieved in 17 patients (71%). Vascular closure device success rate was 100% for the ProGlide device and 37% for the ProStar device, respectively. Seven patients (29%) with failing closure devices were treated by endovascular stent graft implantation without the need for surgical repair. For the last 12 treated patients, direct closure was achieved in 11 patients. Direct puncture of the axillary artery for TAVI is feasible and safe if a wire is placed into the subclavian artery via the ipsilateral brachial artery.

Prediction of Cerebral Hyperperfusion after Carotid Endarterectomy with Transcranial Doppler

The effectiveness of percutaneous access with large vessel closure (pEVR) in non-selective groups of patients undergoing endovascular aneurysm repair (EVR) remains unclear. This study aims to identify factors that predict success in pEVR, performed using percutaneous access and the Prostar XL (Abbott Vascular, Redwood City, Calif) closure device.

Unselected Percutaneous Access with Large Vessel Closure for Endovascular Aortic Surgery: Experience and Predictors of Technical Success

Unselected Percutaneous Access with Large Vessel Closure for Endovascular Aortic Surgery: Experience and Predictors of Technical Success

Unselected Percutaneous Access with Large Vessel Closure for Endovascular Aortic Surgery: Experience and Predictors of Technical Success

IntroductionThe effectiveness of percutaneous access with large vessel closure (pEVR) in non-selective groups of patients undergoing endovascular aneurysm repair (EVR) remains unclear. This study aims to identify factors that predict success in pEVR, performed using percutaneous access and the Prostar XL (Abbott Vascular, Redwood City, Calif) closure device. MethodConsecutive patients who underwent pEVR between April 2010 and March 2011 were identified from a prospectively maintained database. Procedural and postoperative outcomes were compared with consecutive patients who underwent endovascular aneurysm repair using standard open femoral access between April 2008 and March 2009. To determine the predictors of technical success of pEVR, the association between clinical, anatomical and procedural variables with technical success, were examined in a multiple logistic regression model. ResultspEVR was attempted in 186 common femoral arteries (CFAs) with a technical success rate of 95.2% (177/186). Conventional open femoral access in the historic control group was performed in 208 CFAs. pEVR was associated with a reduced operation length (131 min [105–152] versus 150 min [124–195], p≤0.001) and length of stay (2 days [2–5] versus 4 days [2–7], p = 0.01) in patients undergoing infrarenal EVR.In secondary analysis of outcomes following percutaneous access in 91 CFAs, pre-operative renal failure, CFA depth (min and max), CFA diameter (min and max) and operator experience predicted success of percutaneous access in univariate analysis. Operator experience was the only independent predictor of technical success (p = 0.05) after adjustment for all confounding variables. ConclusionpEVR using the Prostar XL device is effective in the majority of patients. In this study there were benefits in terms of reduced postoperative complications, shorter procedures and decreased lengths of stay. Operator experience is a predictor of technical success for pEVR, irrespective of clinical and morphological characteristics at baseline.

Fondaparinux in Percutaneous Coronary Intervention for the Treatment of Acute Coronary Syndrome

Fondaparinux is an agent that has a well-established safety and efficacy profile in the treatment of non-ST segment elevation acute coronary syndromes. When used alone, however, it is associated with a higher incidence of thrombotic complications during invasive coronary procedures, requiring the supplementation of an anti-IIa agent. This study aimed to evaluate the efficacy and safety of percutaneous coronary intervention (PCI) in patients with non-ST segment elevation acute coronary syndromes that were previously treated with fondaparinux. This was a prospective, controlled registry, enrolling 127 consecutive patients submitted to an early invasive stratification during treatment with fondaparinux with the supplementation of intravenous unfractionated heparin at a dose of 85 U/kg at the time of PCI. The composite primary endpoint rate, including death, acute myocardial infarction, stroke, stent thrombosis, or emergency myocardial revascularisation was 3.2%. The cumulative incidence of major bleeding and vascular complications was 3.2%. There were no cases of guide catheter thrombosis or abrupt vessel closure. PCI in patients with acute coronary syndromes receiving fondaparinux was associated with a low rate of major adverse cardiovascular ischaemic events and severe haemorrhagic complications. Supplementation with unfractionated heparin during the invasive procedures eliminated the risk of catheter-related thrombosis. Fondaparinux em Intervenção Coronária Percutânea no Tratamento da Síndrome Coronária Aguda Considerado um fármaco com adequado perfil de eficácia e segurança no tratamento da síndrome coronária aguda sem supradesnivelamento do segmento ST, o fonda parinux, utilizado de forma isolada, associase a maior ocorrência de complicações trombóticas durante a realização de procedimentos coronários invasivos, requerendo a adição de agente com atividade anti-IIa. Este estudo teve como objetivo avaliar a eficácia e a segurança da intervenção coronária percutânea (ICP) em pacientes admitidos com diagnóstico de síndrome coronária aguda sem supradesnivelamento do segmento ST, previamente tratados com fondaparinux. Registro prospectivo, controlado, envolvendo 127 pacientes consecutivos submetidos a estratificação invasiva precoce na vigência de fondaparinux, com suplementação de heparina não fracionada intravenosa na dose de 85 U/kg no momento da ICP. A taxa do desfecho primário, composto por morte, infarto agudo do miocárdio, acidente vascular encefálico, trombose de stent ou revascularização miocárdica de urgência, foi de 3,2%. A incidência acumulada de sangramento grave e complicações vasculares foi de 3,2%. Não houve casos de trombose do cateterguia ou oclusão abrupta do vaso. A ICP em pacientes com síndrome coronária aguda em uso de fondaparinux associase a baixas taxas de eventos cardiovasculares adversos isquêmicos e de complicações hemorrágicas graves. A suplementação com heparina não fracionada durante o procedimento invasivo elimina o risco de trombose do cateter.

Nagłe zamknięcie naczynia po podaniu kontrastu w miejscu pękniętej blaszki miażdżycowej zidentyfikowanej w badaniu metodą tomografii komputerowej tętnic wieńcowych

Nagłe zamknięcie naczynia po podaniu kontrastu w miejscu pękniętej blaszki miażdżycowej zidentyfikowanej w badaniu metodą tomografii komputerowej tętnic wieńcowych

Transfemoral use of the guideLiner catheter in complex coronary and bypass graft interventions

The GuideLiner catheter (Vascular Solutions, Minneapolis, MN) is a novel, rapid exchange catheter that allows deep vessel intubation. We describe 21 patients in whom the GuideLiner catheter [7 French (F) in 76% and 6F in 24%] was used to facilitate equipment delivery (n = 14) or vessel engagement (n = 7). Pressure dampening after GuideLiner catheter insertion was observed in 12 patients (57%). The procedure was successfully completed in 19 patients (90%) and one patient developed acute vessel closure, likely due to dissection. The GuideLiner catheter can facilitate complex coronary interventions but should be used with caution to minimize the risk for vessel injury.

DEVELOPMENT OF IN VITRO PROPAGATION AND CONSERVATION PROTOCOLS OF THE NATIVE BRAZILIAN MANGABA TREE

DEVELOPMENT OF IN VITRO PROPAGATION AND CONSERVATION PROTOCOLS OF THE NATIVE BRAZILIAN MANGABA TREE

Technology‐assisted and sutureless microvascular anastomoses: Evidence for current techniques

Since the birth of reconstructive microvascular surgery, attempts have been made to shorten the operative time while maintaining patency and efficacy. Several devices have been developed to aid microsurgical anastomoses. This article investigates each of the currently available technologies and attempts to provide objective evidence supporting their use. Techniques of microvascular anastomosis were investigated by performing searches of the online databases Medline and Pubmed. Returned results were assessed according to the criteria for ranking medical evidence advocated by the Oxford Centre for Evidence Based Medicine. Emphasis was placed on publications with quantifiable endpoints such as unplanned return to theatre, flap salvage, and complication rates. There is a relative paucity of high-level evidence supporting any form of assisted microvascular anastomosis. Specifically, there are no randomized prospective trials comparing outcomes using one method versus any other. However, comparative retrospective cohort studies do exist and have demonstrated convincing advantages of certain techniques. In particular, the Unilink™/3M™ coupler and the Autosuture™ Vessel Closure System® (VCS®) clip applicator have been shown to have level 2b evidence supporting their use, meaning that the body of evidence achieves a level of comparative cohort studies. Of the available forms of assisted microvascular anastomoses, there is level 2b evidence suggesting a positive outcome with the use of the Unilink™/3M™ coupler and the Autosuture™ VCS® clip applicator. Other techniques such as cyanoacrylates, fibrin glues, the Medtronic™ U-Clip®, and laser bonding have low levels of evidence supporting their use. Further research is required to establish any role for these techniques.

Radiation and Ethylene Oxide Terminal Sterilization Experiences with Drug Eluting Stent Products

Radiation and ethylene oxide terminal sterilization are the two most frequently used processes in the medical device industry to render product within the final sterile barrier package free from viable microorganisms. They are efficacious, safe, and efficient approaches to the manufacture of sterile product. Terminal sterilization is routinely applied to a wide variety of commodity healthcare products (drapes, gowns, etc.) and implantable medical devices (bare metal stents, heart valves, vessel closure devices, etc.) along with products used during implantation procedures (catheters, guidewires, etc.). Terminal sterilization is also routinely used for processing combination products where devices, drugs, and/or biologics are combined on a single product. High patient safety, robust standards, routine process controls, and low-cost manufacturing are appealing aspects of terminal sterilization. As the field of combination products continues to expand and evolve, opportunity exists to expand the application of terminal sterilization to new combination products. Material compatibility challenges must be overcome to realize these opportunities. This article introduces the reader to terminal sterilization concepts, technologies, and the related standards that span different industries (pharmaceutical, medical device, biopharmaceuticals, etc.) and provides guidance on the application of these technologies. Guidance and examples of the application of terminal sterilization are discussed using experiences with drug eluting stents and bioresorbable vascular restoration devices. The examples provide insight into selecting the sterilization method, developing the process around it, and finally qualifying/validating the product in preparation for regulatory approval and commercialization. Future activities, including new sterilization technologies, are briefly discussed.

Pseudoaneurysm and Abscess of the Left Anterior Descending Coronary Artery

A 41-year-old man presented with a 2-week history of intermittent fever of unknown origin and atypical chest pain without any electrocardiographic evidence of ischemia. He had been operated on at the age of 7 for the closure of a coronary fistula connecting the left anterior descending coronary artery (LAD) to the right ventricle. During that procedure, a large aneurysmal coronary artery leading to the fistula had been opened, and the fistula had been closed from within, followed by the closure of the aneurysmal vessel by plication.

Pilot Study of the Delivery of Microcollimated Pars Plana External Beam Radiation in Porcine Eyes

To investigate the effects of a novel stereotactic radiosurgical system for pars plana delivery of microcollimated x-rays to the retina and determine the retinal radiological dose response and toxicity threshold in a pig model. The x-rays were delivered through the pars plana to the maculae of Yucatan miniswine to verify the targeting and safety of a cornea-scleral, stabilized, office-based delivery system. Twelve eyes were randomized to receive 0, 16, 24, 42, 60, or 90 Gy in a single dose to the retina. Eye examinations, fundus photography, fluorescein angiography, and spectral-domain optical coherence tomography were obtained at days 7, 30, 60, and 90. Indocyanine green angiography was done at day 90. Through day 90 interim analysis, no abnormalities of external structures were noted. A small cortical lens opacity was noted in the 60-Gy group. Fundus evaluation revealed no abnormalities at 16 or 24 Gy. Beginning at day 30, circular pale retinal lesions with sharp margins were noted in the maculae of the eyes that received 42, 60, and 90 Gy. Higher-dose lesions showed late staining on fluorescein angiography, choroidal hypoperfusion on indocyanine green angiography, and defined photoreceptor loss and retinal thinning on spectral-domain optical coherence tomography. Transscleral stereotactic radiation dosing of porcine eyes demonstrates no apparent clinical abnormalities in doses less than 24 Gy. Doses of 42 Gy or higher led to focal choroidal and retinal damage within the target area. Radiation can induce small-blood vessel closure and thereby has therapeutic potential in neovascular diseases such as age-related macular degeneration.

Impact of culprit vessel location in acute myocardial infarction on clinical outcome

Among 3,548 patients undergoing a percutaneous transluminal coronary angioplasty procedure, 714 had multilesion angioplasty (1,550 lesions) in a single session. Acute occlusion occurred in 22 patients (3.1%) and 29 lesions (1.9%). The patients were classified into a group undergoing multivessel angioplasty (348 patients, 785 lesions) and a group undergoing multilesion single vessel angioplasty (366 patients, 765 lesions). The rate of acute occlusion was similar in both patient groups. The multivessel angioplasty group had a 2.9% rate per patient (n = 10) and a 1.7% rate per vessel; the multilesion single vessel group had a 3.3% rate per patient (n = 12) and a 2.1 % rate per lesion.Five of the 10 patients from the multivessel group with acute occlusion, but only 1 of the 12 patients with occlusion in the single vessel multilesion group, required emergency open heart surgery. No patient in either group died as a consequence of coronary angioplasty. Occlusion occurred during angioplasty in 15 of the 22 patients, and 1 to 24 h after angioplasty in 7 of 22 patients. In the group with multivessel angioplasty, acute occlusion during the procedure was mainly linked with hypotension during the second vessel dilation, whereas in this group with delayed vessel closure and in the multilesion single vessel group, existence of intimal tearing constituted the most important factor for acute occlusion (12 of 16 patients). Closure of vessel per major coronary system was evenly distributed in the multivessel group, whereas significantly more left circumflex vessels closed in the single vessel multilesion group (6.1% versus 1.3% in the left anterior descending coronary artery and 1.1 % in the right coronary artery; p < 0.02). Maximal increase in serum creatine kinase after angioplasty was significantly lower in the single vessel multilesion group than in the multivessel group (563 versus 1,749 U/liter; p < 0.01).The multilesion angioplasty procedure is associated with acceptable risk. However, with an increasing amount of myocardium at risk, procedural risk is higher if more than one vessel system is dilated. Staged multivessel angioplasty with serial angioplasty on different vessel systems on separate days should be considered if factors predisposing to acute occlusion, such as hypotension or intimal tear, are present after the first dilation.

Angioplasty for Treatment of Isolated Below-the-Knee Arterial Stenosis in Patients With Critical Limb Ischemia

To report our experience in patients with critical limb ischemia (CLI) due to isolated below-the-knee (BTK) arterial lesions. Between 1992 and 2009, we performed 2747 peripheral angioplasties, while 2.8% (78 of 2747) were only BTK and were included in the present study. Mean age was 70.2 ± 11 years, 58.4% had diabetic, 85.7% were smokers, and 20.8% had chronic renal failure. Baseline Rutherford class: 50 patients with class IV and 27 with class V to VI. Angiographic and clinical success were 97.4% and 90.91%, respectively. At 30 days, there were no deaths, 2 patients had acute vessel closure and 2 major amputation. At long-term follow-up (22.4 ± 9.6 months), there were 7 unrelated deaths (10%), 5 amputations (7.1%), 3 reinterventions (4.2%), while 16 patients remained symptomatic. Overall amputation and amputation plus claudication-free survival were 90% and 70%, respectively. Endovascular treatment of BTK lesions represents a safe and effective treatment option to patients with CLI.

Bioresorbable Scaffold

The invention of balloon angioplasty as a percutaneous treatment for obstructive coronary disease by Andreas Gruntzig in 1977 was a huge leap forward in cardiovascular medicine and undoubtedly will always be remembered as a revolution in the field of revascularization. However, this technique was plagued by multiple problems, including the risk of acute vessel closure secondary to occlusive coronary dissection, sometimes necessitating emergency coronary artery bypass surgery.1,–,3 Although late luminal enlargement and vascular remodeling could take place, more often restenosis4,–,8 would occur instead. The restenosis would essentially be caused by constrictive remodeling9,–,13 and, to a lesser extent, by elastic recoil14 or the neointimal hyperplastic healing response.15,–,17 The advent of bare metal stenting (BMS) and the landmark Belgian-Netherlands Stent Study (BENESTENT) and Stent Restenosis Study (STRESS) trials have established BMS as the second revolution in interventional cardiology.18,19 This technology provided a solution to acute vessel occlusion by sealing the dissection flaps and preventing recoil. The rate of subacute occlusion was reduced to 1.5%, making emergency bypass surgery a rare occurrence. Restenosis rates were further reduced from 32% to 22% at 7 months, but this rate was still high, and neointimal hyperplasia inside the stent was even more prominent than with angioplasty, necessitating repeat treatment in numerous patients.18 Because the vessel was now caged with metal, late luminal enlargement and advantageous vascular remodeling could no longer occur. Another problem, namely late stent thrombosis (ST), was also first described.20 To solve the problem of in-stent restenosis, after the historic failure of brachytherapy to resolve this problem,21,22 drug-eluting stents (DES) were introduced. The first 45 patients implanted with the sirolimus-eluting Bx velocity stent (Cordis, Johnson …

A prospective randomized single-blind trial of patient comfort following vessel closure: extravascular synthetic sealant closure provides less pain than a self-tightening suture vascular compression device

Background and purposeThe Mynx M5 (AccessClosure, Inc., Mountain View, California, USA), a novel vascular closure device (VCD) utilizing extravascular synthetic sealant, may effectively seal the arteriotomy while reducing the pain...

The hunt for genetic risk among Mysore, south India patent ductus arteriosus patients

Of the estimated 21 million babies annually born premature or with serious birth defects worldwide, more than 4 million die before the age of 51. Although they constitute a diverse anatomical grouping, cardiac abnormalities taken together constitute the most common congenital malformations with frequencies around 1 per cent. Serious life threatening complications can occur from many cardiac structural defects, particularly those that involve an abnormal mixing of oxygenated with oxygen-depleted blood supplies. One such cardiac malformation is patent ductus arteriosus (PAD), a defect that arises from differences in the routing of foetal blood before and after birth. While still developing in the womb, blood circulation bypasses the foetus’ lungs (which do not have access to their own oxygen supply) by connecting the pulmonary artery (normally supplying blood to the lungs) with the aorta (supplying blood to the body) through a foetal heart structure known as the ductus arteriosus. After birth, this blood vessel is no longer needed and closes off, since the infant's lungs now take on the role of supplying oxygen. Closure of this blood vessel ensures the normal separation of oxygenated and de-oxygenated blood flow after birth. In PAD, the ductus arteriosus fails to close following birth, and the normal segregation of blood flow is disrupted, often with serious consequences.