ABSTRACT
Vascular closure devices (VCDs) are widely used as an alternative to manual compression of femoral puncture sites. In this report, we present a 73-year-old man who developed symptomatic venous stenosis related to VCD after pulmonary vein isolation. We performed percutaneous treatment with balloon angioplasty. This case suggests that balloon angioplasty with proper safety measures can be an option for treating venous stenosis related to VCDs.
Subject(s)
Cardiovascular Abnormalities , Vascular Closure Devices , Vascular Diseases , Aged , Constriction, Pathologic , Femoral Artery/surgery , Hemostatic Techniques , Humans , Male , Punctures , Treatment Outcome , Vascular Diseases/diagnostic imaging , Vascular Diseases/etiology , Vascular Diseases/therapyABSTRACT
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.
Subject(s)
Angioplasty, Balloon , Atherectomy , Femoral Artery/surgery , Hemorrhage/prevention & control , Peripheral Arterial Disease/surgery , Suture Techniques/adverse effects , Vascular Closure Devices/adverse effects , Aged , Angiography , Angioplasty, Balloon/adverse effects , Atherectomy/adverse effects , Constriction, Pathologic , Femoral Artery/diagnostic imaging , Hemorrhage/etiology , Humans , Male , Peripheral Arterial Disease/diagnostic imaging , Peripheral Arterial Disease/etiology , Punctures , Suture Techniques/instrumentation , Treatment Outcome , Ultrasonography, Doppler, ColorABSTRACT
OBJECTIVES: To compare complication rates, length of hospital stay, and resulting costs between the use of manual compression and a vascular closing device (VCD) in both diagnostic and interventional catheterization in a German university hospital setting. METHODS: A stratified analysis according to risk profiles was used to compare the risk of complications in a retrospective cross-sectional single-center study. Differences in costs and length of hospital stay were calculated using the recycled predictions method, based on regression coefficients from generalized linear models with gamma distribution. All models were adjusted for propensity score and possible confounders, such as age, sex, and comorbidities. The analysis was performed separately for diagnostic and interventional catheterization. RESULTS: The unadjusted relative risk (RR) of complications was not significantly different in diagnostic catheterization when a VCD was used (RR = 0.70; 95% confidence interval [CI] 0.22-2.16) but significantly lower in interventional catheterization (RR = 0.44; 95% CI 0.21-0.93). Costs were on average 275 lower in the diagnostic group (95% CI -478.0 to -64.9; P = 0.006) and around 373 lower in the interventional group (95% CI -630.0 to -104.2; P = 0.014) when a VCD was used. The adjusted estimated average length of stay did not differ significantly between the use of a VCD and manual compression in both types of catheterization. CONCLUSIONS: In interventional catheterization, VCDs significantly reduced unadjusted complication rates, as well as costs. A significant reduction in costs also supports their usage in diagnostic catheterization on a larger scale.
Subject(s)
Cardiac Catheterization/methods , Length of Stay/statistics & numerical data , Percutaneous Coronary Intervention/methods , Vascular Closure Devices , Aged , Cardiac Catheterization/adverse effects , Cardiac Catheterization/economics , Cross-Sectional Studies , Female , Femoral Artery , Germany , Hospital Costs , Hospitalization/economics , Hospitalization/statistics & numerical data , Hospitals, University , Humans , Length of Stay/economics , Male , Middle Aged , Percutaneous Coronary Intervention/economics , Retrospective StudiesABSTRACT
Complex and huge wound closure is a key step in pre hospital emergency care. Wound closure can effectively reduce the loss of blood and fluid inpatients before arriving hospital. Also, it has important significance to save the lives of patients. In this paper, a new type of wound closure device is developed, which is used for the rapid closure of complex and huge wound. Firstly, based on the detailed introduction of the structure working principle, the finite element simulation technology is adopted to analyze the stress of the structure. The results show that the stress of the structure has not beyond the allowable stress of the material. On the basis of this, the experiment was carried out in vitro. Test results show that the closure device operating time is 18.24 s and the minimum penetration of the skin force is 4.08 kg. The closure device can resist the horizontal tension of 1.53 kg and vertical tension of 2.25 kg. It also has good sealing performance and meets the design requirements. The results show that the device designed is reasonable, which can be quickly and effectively to achieve closure of the wound.
Subject(s)
Emergency Medical Services , Equipment Design , Wounds and Injuries/therapy , Humans , Skin , Wound HealingABSTRACT
By developing a novel endoscopic succession closing device to overcome the shortcomings of existing devices that cannot deploy several clips at a time, to perform structural analysis on different clamp structures and to validate their performances in tissue closure through finite element analysis. Methods Comparative analyses of three clamp structures, namely, the aligning tooth structure (original, clamp A), the staggered tooth structure (clamp B), a combination structure with page break angle and staggered tooth (clamp C), were performed to analyze pressure and its distribution on tissues when clamping the stomach wall. Displacement of 7.5 mm was then applied on the clamps to simulate the effect of the operating procedures of the device and tissue kick-back. Results The maximum stresses of the clamp A and B were located on the first pair of teeth which was closest to the rotating shaft, with the stress being 10.39 kPa and 10.11 kPa, respectively. The maximum stress (11.35 kPa) of the clamp C was located on the second pair of teeth. For clamp A and B, the longer the distance to shaft, the larger pressure on stomach tissues. While for clamp C, the pressure on device-tissue interface showed little change along the path. Under tensile displacement, clamp A and B slipped off from the tissue when displacements reached to 5 mm and 6.5 mm, respectively, while clamp C did not. Conclusions Clamp with page break angle and staggered tooth can exert the uniform max pressure to tissues and provide a larger contact area away from the rotating shaft, thus improving anti-slippage and performance of the novel endoscopic closing device.
ABSTRACT
Objective By developing a novel endoscopic succession closing device to overcome the shortcomings of existing devices that cannot deploy several clips at one time,to perform structural analysis on different clamp structures and to validate their performances in tissue closure through finite element analysis.Metbods Comparative analyses of 3 clamp structures,namely,the aligning tooth structure (original,clamp A),the staggered tooth structure (clamp B),a combination structure with page break angle and staggered tooth (clamp C),were performed to analyze pressure and its distribution on tissues when clamping the stomach wall.Displacement of 7.5 mm was then applied on the clamps to simulate the effect from operating procedures of the device and tissue kick-back.Results The maximum stresses of the clamp A and B were located on the first pair of teeth which was closest to the rotating shaft,with the stress of 10.39 kPa and 10.11 kPa,respectively.The maximum stress (11.35 kPa) of the clamp C was located on the second pair of teeth.For clamp A and B,the longer the distance to shaft,the larger pressure on stomach tissues.While for clamp C,the pressure on device-tissue interface showed little change along the path.Under tensile displacement,clamp A and B slipped off from the tissue when displacements reached to 5.0 mm and 6.5 mm,respectively,while clamp C did not slip off.Conclusions Clamp with page break angle and staggered tooth can exert the uniform maximum pressure to tissues and provide a larger contact area away from the rotating shaft,thus improving the anti-slippage and performance of the novel endoscopic closing device.
ABSTRACT
Objective By developing a novel endoscopic succession closing device to overcome the shortcomings of existing devices that cannot deploy several clips at one time,to perform structural analysis on different clamp structures and to validate their performances in tissue closure through finite element analysis.Metbods Comparative analyses of 3 clamp structures,namely,the aligning tooth structure (original,clamp A),the staggered tooth structure (clamp B),a combination structure with page break angle and staggered tooth (clamp C),were performed to analyze pressure and its distribution on tissues when clamping the stomach wall.Displacement of 7.5 mm was then applied on the clamps to simulate the effect from operating procedures of the device and tissue kick-back.Results The maximum stresses of the clamp A and B were located on the first pair of teeth which was closest to the rotating shaft,with the stress of 10.39 kPa and 10.11 kPa,respectively.The maximum stress (11.35 kPa) of the clamp C was located on the second pair of teeth.For clamp A and B,the longer the distance to shaft,the larger pressure on stomach tissues.While for clamp C,the pressure on device-tissue interface showed little change along the path.Under tensile displacement,clamp A and B slipped off from the tissue when displacements reached to 5.0 mm and 6.5 mm,respectively,while clamp C did not slip off.Conclusions Clamp with page break angle and staggered tooth can exert the uniform maximum pressure to tissues and provide a larger contact area away from the rotating shaft,thus improving the anti-slippage and performance of the novel endoscopic closing device.
ABSTRACT
Objective By developing a novel endoscopic succession closing device to overcome the shortcomings of existing devices that cannot deploy several clips at one time,to perform structural analysis on different clamp structures and to validate their performances in tissue closure through finite element analysis.Metbods Comparative analyses of 3 clamp structures,namely,the aligning tooth structure (original,clamp A),the staggered tooth structure (clamp B),a combination structure with page break angle and staggered tooth (clamp C),were performed to analyze pressure and its distribution on tissues when clamping the stomach wall.Displacement of 7.5 mm was then applied on the clamps to simulate the effect from operating procedures of the device and tissue kick-back.Results The maximum stresses of the clamp A and B were located on the first pair of teeth which was closest to the rotating shaft,with the stress of 10.39 kPa and 10.11 kPa,respectively.The maximum stress (11.35 kPa) of the clamp C was located on the second pair of teeth.For clamp A and B,the longer the distance to shaft,the larger pressure on stomach tissues.While for clamp C,the pressure on device-tissue interface showed little change along the path.Under tensile displacement,clamp A and B slipped off from the tissue when displacements reached to 5.0 mm and 6.5 mm,respectively,while clamp C did not slip off.Conclusions Clamp with page break angle and staggered tooth can exert the uniform maximum pressure to tissues and provide a larger contact area away from the rotating shaft,thus improving the anti-slippage and performance of the novel endoscopic closing device.
ABSTRACT
Resumen La erosión tardía de la pared auricular y de la aorta es una causa infrecuente, pero potencialmente mortal en los pacientes que han sido sometidos al cierre percutáneo de un defecto del septum auricular, en especial cuando existe una alta relación entre el tamaño del dispositivo escogido con el tamaño del defecto y la presencia de bordes insuficientes. Presentamos el caso de un hombre de 70 años con un episodio de colapso hemodinámico secundario a taponamiento cardiaco debido a erosión muy tardía de la aurícula derecha por un Amplatzer® implantado 4 años atrás para el cierre de un defecto septal auricular. Conclusión La erosión tardía de los dispositivos de cierre percutáneo para los defectos atriales, aunque infrecuente, deberá ser tenida en cuenta en los pacientes que presentan colapso hemodinámico.
Abstract Late atrial wall and aorta erosion is a rare cause of potential fatallity in patients who have undergone percutaneous closure of an atrial septal defect, especially when a high ratio device to defect is chosen, and an insufficient aortic rim is present. We report the case of a 70 year old male with an episode of hemodinamic collapse secondary to cardiac tamponade due to a late erosion of a 4 years ago implanted Amplatzer® used to close an atrial septal defect. Conclusion Very late wall erosion of an atrial septal closure device, although uncommon, should be suspected in patients presenting with hemodynamic collapse.
Subject(s)
Humans , Male , Aged , Postoperative Complications/etiology , Septal Occluder Device/adverse effects , Heart Atria/injuries , Heart Septal Defects, Atrial/surgery , Time FactorsABSTRACT
UNLABELLED: Late atrial wall and aorta erosion is a rare cause of potential fatallity in patients who have undergone percutaneous closure of an atrial septal defect, especially when a high ratio device to defect is chosen, and an insufficient aortic rim is present. We report the case of a 70 year old male with an episode of hemodinamic collapse secondary to cardiac tamponade due to a late erosion of a 4 years ago implanted Amplatzer(®) used to close an atrial septal defect. CONCLUSION: Very late wall erosion of an atrial septal closure device, although uncommon, should be suspected in patients presenting with hemodynamic collapse.
Subject(s)
Heart Atria/injuries , Heart Septal Defects, Atrial/surgery , Postoperative Complications/etiology , Septal Occluder Device/adverse effects , Aged , Humans , Male , Time FactorsABSTRACT
Objective To design a novel endoscopic successive hemostasis and closing device, and to validate whether the device can meet the needs of tissue closure by finite element analysis. Methods By using the novel device, the target tissue was clamped and the clip was then pushed to pierce the tissue. Under the compression between the clip and the inner side of the grasper, the thinner arms of the clip were forced to bend and close to stay in the tissue, and then the inverse displacement of 2 mm was applied on the clip. The elastic limit and tensile strength of the clip were set as 239.0 and 901.0 MPa, respectively. Results Deformation did not occur in the piercing process of the clip, with the maximum stress of 212.6 MPa. The deformed shape of the clip in the bending process matched its design expectation, with the maximum stress of 727.7 MPa. The maximum stress of the clip was 75.8 MPa under 2-mm inverse displacement. Material failure was not found in the bending process or with 2-mm inverse displacement, and the maximum stress in the whole process was 741.0 MPa. Conclusions The novel endoscopic successive hemostasis and closing device proposed in this study can deploy 4 clips at one time, together with an independent grasper for gathering tissues, which can shorten the reloading time and improve the accuracy of clip deployment. The effectiveness and safety of the device is also proved by using finite element method.
Subject(s)
Atrial Appendage/surgery , Atrial Fibrillation/therapy , Incidental Findings , Septal Occluder Device/adverse effects , Thromboembolism/diagnosis , Aged , Atrial Appendage/diagnostic imaging , Atrial Appendage/physiopathology , Atrial Fibrillation/diagnosis , Cardiac Surgical Procedures/adverse effects , Cardiac Surgical Procedures/methods , Coronary Artery Bypass/methods , Coronary Stenosis/diagnostic imaging , Coronary Stenosis/surgery , Device Removal , Echocardiography, Transesophageal/methods , Follow-Up Studies , Humans , Male , Preoperative Care/methods , Prosthesis Failure , Radiography , Risk Assessment , Severity of Illness Index , Thromboembolism/etiology , Treatment OutcomeABSTRACT
INTRODUCTION: There are clear benefits of percutaneous versus open femoral access for endovascular aortic pathology repair. All closing devices commercially available are expensive. Surgical closure of the femoral artery risks potential prolonged wound healing and as a consequence longer hospital stay. Fascial closure is a technique that remains an interesting option. AIM: To evaluate the efficacy of the surgical modification of hemostasis control after endovascular repair of aortic pathology. MATERIAL AND METHODS: One hundred sixteen common femoral arteries in a group of 58 patients underwent a minimally invasive procedure. Patients suffering from abdominal, thoracic aorta aneurysms, acute thoracic aorta type B dissections and traumatic aortic injury were treated. RESULTS: A 1-year period of experience in fascial closure of 116 common femoral arteries was presented in the group of 58 patients undergoing endovascular interventions. Five intraoperative complications were observed and one late. Three primary failures were due to hemorrhage in three arteries, one required open repair and two additional compression after the procedure. Two cases of limb ischemia required surgical correction of artery closure. One limb ischemia was detected 4 weeks later, and was treated conservatively. At 1 year, 92 fascial closures (80%) were in the follow-up and 24 (20%) were lost to follow-up. CONCLUSIONS: This new modification of fascial closure is a safe and cheap method of arterial closure following endovascular repair of selected aortic pathologies. The usage of two suture lines makes this procedure easy and quick. Fascial closure technique is comparable to other techniques in terms of success and complication rates.
ABSTRACT
Objetivo: determinar la utilidad del ecocardiograma intracardiaco como ayuda para la implantación de dispositivo de cierre percutáneo de foramen ovale permeable. Material y métodos: se expone el caso de un paciente de género masculino, de 38 años de edad, con antecedentes de isquemia cerebral transitoria, diagnosticada un año antes, quien presentó cuadro de accidente cerebrovascular isquémico criptogénico y se le detectó foramen ovale permeable por ecocardiograma transesofágico. Se candidatizó para cierre percutáneo con dispositivo de cierre tipo Amplatzer, y se programó el procedimiento con ecocardiograma intracardiaco mediante sonda AcuNav para guiar la colocación del Amplatzer, junto con el ecocardiograma transesofágico tradicional requerido en estos casos. Resultados: se realizó cierre del foramen ovale permeable mediante la técnica aceptada, guiado por ecocardiografía intracardiaca y se verificó mediante angiografía y ecocardiograma transesofágico. Se obtuvieron imágenes de la anatomía cardiaca mediante ecocardiograma intracardiaco en tiempo real sin interferencia, con lo cual pudo hacerse el implante del dispositivo en forma rápida y adecuada. Se corroboró su correcta implantación a través de angiografía y ecocardiograma transesofágico. En este caso, el procedimiento de cierre percutáneo con dispositivo de Amplatzer fue exitoso, rápido y sin complicaciones. Conclusiones: el ecocardiograma intracardiaco es útil para guiar la implantación de dispositivos de cierre del foramen ovale permeable así como en casos de comunicación interauricular. Es una técnica fácil y segura. La introducción de la sonda de ecocardiograma intracardiaco, su manipulación y su posicionamiento en el atrio derecho fueron rápidos y sencillos. Se obtuvieron imágenes adecuadas con una buena identificación de las estructuras del septum que permitieron el cierre exitoso del foramen ovale permeable con dispositivo tipo Amplatzer. Según esta investigación, en la literatura no se reporta el ecocardiograma intracardiaco como ayuda para guiar este procedimiento, por lo que se considera que pudiera ser el primer caso realizado en Colombia. De otra parte, se hace necesario el uso más generalizado de la sonda intracardiaca para realizar ecocardiograma intracavitario e implementarlo en lugar del ecocardiograma transesofágico como guía para cierre de comunicación interauricular y foramen ovale permeable. Es conveniente llevar a cabo más estudios que permitan valorar mejor esta ayuda que puede suprimir la necesidad del ecocardiograma transesofágico en estos pacientes y a su vez el requerimiento de anestesia general para estos procedimientos.
Objective: to determine the utility of intracardiac echocardiography to assist in the implantation of the device for percutaneous closure of patent foramen ovale. Material and methods: we report the case of a 38 years old male patient with a history of transient cerebral ischemia diagnosed a year earlier, who presented a clinical picture of ischemic cryptogenic stroke. A transesophageal echocardiogram showed a patent foramen ovale. He was scheduled for percutaneous closure of the patent foramen ovale with Amplatzer closure device, and the procedure was programmed with intracardiac echocardiography probe through AcuNav to guide the placement of the Amplatzer, along with the traditional TEE required in these cases. Results: we performed foramen ovale closure using the accepted technique, guided by intracardiac echocardiography and verified by angiography and transesophageal echocardiography. We obtained images of cardiac anatomy using intracardiac echocardiography in real time without interference, which made possible the implant of the device quickly and appropriately. Proper implementation was confirmed by angiography and transesophageal echocardiography. In this case, the procedure of percutaneous closure with Amplatzer device was successful, fast and without complications. Conclusions: intracardiac echocardiography is useful to guide the implantation of devices for closure of patent foramen ovale as well as in cases of atrial septal defect. This technique is easy and safe. The introduction of intracardiac echocardiography catheter, its handling and positioning in the right atrium were quick and easy. Adequate images were obtained with a good identification of the structures of the septum that allowed the successful closure of the foramen ovale with Amplatzer device. According to this research, the literature does not report intracardiac echocardiography as an assistance to guide this procedure, so that we believe this may be the first case performed in Colombia. Moreover, it is necessary a more widespread use of intracardiac catheter for intracavitary echocardiography and implement it instead of transesophageal echocardiography as guide for closure of atrial septal defect and patent foramen ovale. It is convenient to carry out more studies to better assess this assistance which may eliminate the need of transesophageal echocardiography in these patients and in turn the requirement of general anesthesia for these procedures.
Subject(s)
Humans , Male , Adult , Echocardiography, Transesophageal , Foramen Ovale, Patent , Echocardiography , Equipment and SuppliesABSTRACT
Objective:To assess the safety and efficacy of the standard manual compression and 2 arterial puncture closing devices,Angioseal and Perclose,for hemostasis at the femoral artery access site in patients undergoing coronary angiography(CAG) or percutaneous coronary interventions(PCI).Methods: Totally 366 patients undergoing coronary angiography or PCI were assigned to receive either Angioseal(n=128),Perclose(n=110) or standard manual compression(n=128).The efficacy endpoint(immediate hemostasis,successful hemostasis rate,operating time,time of leg immobilization and time to hemostasis) and safety endpoint(vasovagal reflex,major complications,local complications,hematocrit drop,etc.) were evaluated.Risk factors(gender,age,body mass index,comorbid conditions,antiplatelet agents,and anticoagulant agents,etc.) were also analyzed.Results: The successful hemostasis rates were similar between Angioseal group and Perclose group,but the rate of immediate hemostasis of Angioseal group was higher than that of Perclose group(P
