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      Justificación y diseño del estudio multicéntrico prospectivo de cohortes para evaluar los resultados del cierre percutáneo en procedimientos de reparación aórtica endovascular. Registro SPAIN Translated title: Justification and design of the prospective multicentre cohort study to evaluate the results of percutaneous closure in endovascular aortic repair procedures. SPAIN Registry

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          Abstract

          Resumen Introducción: el cierre percutáneo es una herramienta esencial en el tratamiento endovascular actual. Los procedimientos de patología aórtica precisan abordajes arteriales de gran calibre a nivel inguinal, lo que conlleva mayor posibilidad de complicaciones en el cierre. Es por esto que actualmente continúan conviviendo la técnica quirúrgica abierta y el abordaje percutáneo, siendo también así en el territorio nacional, con resultados a día de hoy no cuantificados. La literatura actual aporta buenos resultados para la técnica de presutura en patología aórtica, sin embargo aún existen dudas respecto a determinados factores de riesgo como la obesidad, calcificación severa o arterias de pequeño calibre. Tampoco existen suficientes datos que estudien cómo afecta este procedimiento a la calidad de vida, lo cual es un punto esencial, especialmente en pacientes mayores. Dado que un alto porcentaje de los pacientes que se someten a estas intervenciones son ancianos con patologías concomitantes (los llamados pacientes frágiles), minimizar la agresión quirúrgica y mejorar su calidad de vida inmediata post-procedimiento puede ser determinante. Objetivos: primarios: estimar la tasa de éxito técnico del procedimiento de cierre percutáneo en intervenciones aórticas, estimación del impacto en la calidad de vida así como encontrar posibles diferencias en la morbimortalidad a 30 días en relación a la puntuación de cada paciente en la escala de fragilidad modificada; secundarios: evaluar el tiempo de presutura, tiempo de hemostasia, complicaciones derivadas del cierre, estancia hospitalaria y el dolor posoperatorio. Material y métodos: el Registro SPAIN es un estudio multicéntrico prospectivo de pacientes sometidos a procedimientos percutáneos sobre la aorta y sus ramas con dispositivos ≥ 10 French (F), en el que serán recogidas variables relacionadas con el cierre de sus accesos inguinales. El periodo de seguimiento será de 30 días. La duración del periodo de reclutamiento será de un año inicialmente. Los participantes deben acreditar haber realizado el cierre de al menos 10 abordajes percutáneos de gran calibre (≥ 10 F) en unidades de ámbito nacional de las especialidades de Angiología y Cirugía Vascular y Cardiología. Conclusión: el Registro SPAIN pretende poner en valor toda la evidencia actual y determinar uniformemente mediante el análisis de los datos de una cohorte prospectiva, estandarizada y validada, las variables que influyen en el éxito de la técnica. Pretende obtener datos estandarizados del mayor número posible de centros en España para mostrar cuál es la tasa de éxito y el impacto en la calidad de vida del paciente, especialmente el frágil.

          Translated abstract

          Abstract Introduction: percutaneous closure is an essential tool in current endovascular treatment. Aortic pathology procedures require large-caliber arterial approaches, leading to a greater possibility of closure complications. For this reason, nowadays, both open surgical and the preclose technique coexist in almost every center worldwide, as it does in Spain with no contrasted results. The current literature provides good results for the pre-closing technique in aortic pathology, however there are still doubts regarding certain risk factors such as obesity, severe calcification or small-caliber arteries. There is not enough data to study how this procedure affects quality of life, an essential point, especially in older patients. Minimizing surgical aggression and improving their immediate post-procedure quality of life can be decisive because most of the patients are elderly with concomitant pathologies (fragile patients). Objetives: primary objectives: to estimate the technical success rate of the percutaneous closure procedure in aortic interventions, estimate the impact on quality of life and find possible differences in morbidity and mortality at 30 days in relation to the score of each patient on the frailty scale; secondary objectives: To evaluate the pre-suture time, hemostasis time, complications derived from closure, hospital stay and post-operative pain. Material and methods: the SPAIN Registry is a prospective multicenter study of patients undergoing percutaneous procedures on the aorta and its branches with ≥ 10 French (F) devices. Variables related to the closure of their inguinal access will be collected. The follow-up period will be 30 days. The duration of the recruitment period will be one year initially. Participants must certify that they have performed the closure of at least 10 large caliber percutaneous approaches (≥ 10 F) in national units of the specialties of Angiology and Vascular Surgery and Cardiology. Conclusion: the SPAIN Registry aims to value all current evidence and uniformly state, through the analysis of data from a prospective, standardized and validated cohort, the variables that influences the success of the technique. It aims to standardize the expected results of the technique in the majority of possible centers in Spain to finally show what are the success rates and the effect on the quality of life of the patient, especially the fragile one.

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          Most cited references13

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          A multicenter, randomized, controlled trial of totally percutaneous access versus open femoral exposure for endovascular aortic aneurysm repair (the PEVAR trial).

          The first multicenter randomized controlled trial was designed and conducted to assess the safety and effectiveness of totally percutaneous endovascular aortic aneurysm repair (PEVAR) with use of a 21F endovascular stent graft system and either an 8 F or 10 F suture-mediated closure system (the PEVAR trial, NCT01070069). A noninferiority trial design was chosen to compare percutaneous access with standard open femoral exposure.
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            Trends, complications, and mortality in peripheral vascular surgery.

            The recent evolution in treatments for peripheral vascular disease has dated available mortality statistics for vascular intervention. Moreover, many of our current mortality statistics are derived from single-institution studies that are often not reflective of outcomes in general practice. To provide current and generalizable data regarding mortality and trends for peripheral vascular interventions, we examined two national data sets (Nationwide Inpatient Sample, 1998-2003, and National Hospital Discharge Survey, 1979-2003) and four states (New York, California, Florida, and New Jersey, 1998-2003). Four procedures--abdominal aortic aneurysm repair (nonruptured), lower extremity revascularization, amputation, and carotid revascularization--were selected by cross-referencing International Classification of Diseases, 9th Revision, diagnostic and procedural codes. For significance, the t test was used for continuous variables, the chi2 test was used for dichotomous variables, and the chi2 test was used for mortality trends. From 1998 to 2003, there was a progressive decrease in the national per capita rate of amputations: 13.2% overall and 21.2% for major amputations (P < .0001). Nationally and regionally, mortality has only slightly declined. For lower extremity revascularization, after a sharp increase during the 1980s to 100,000 open procedures, the volume remained constant for 10 years and began to decline in 1998, reaching 70,000 cases in 2003. In contrast, since 1996, endovascular interventions have increased 40%. Mortality during the 1998 to 2003 period remained virtually stable at 1.5% to 2% for endovascular procedures and 3% to 4% for open procedures. The overall volume of abdominal aortic aneurysm repair has not changed substantially for the past 6 years; however, endovascular repair is now used for nearly half the cases (46.5% regional and 43.0% national). Mortality for open repair has not changed, remaining at approximately 5%, whereas for endovascular repair, mortality has declined from 2.6% in 2000 to less than 1.5% in 2003. After the rapid increase in open carotid revascularization in the early 1990s, the total volume has declined 5% nationally from 1998 to 2003. Regional data demonstrated an overall 12% reduction in carotid revascularization volume since 1998; this reduction was due to a 16% decline in open carotid revascularization. During this same period, the use of angioplasty-stent carotid revascularization doubled. Mortality for the open procedures is 0.5% and is significantly higher (2%-3%) for endovascular carotid revascularization. Stroke rates for endovascular carotid revascularization are also higher: 2.13% vs 1.28% for open procedures (P < .0001). Dramatic shifts in the management of peripheral vascular disease have occurred together with an overall decline in mortality. There seems to be a significant mortality advantage for endovascular as compared with traditional surgery except for carotid endarterectomy. The increasing safety of vascular interventions should be considered when deciding which patients to treat but with the caveat that endovascular interventions are not always safer than open repair.
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              Total percutaneous access for endovascular aortic aneurysm repair ("Preclose" technique).

              Percutaneous access during endovascular aneurysm repair has been difficult owing to the large size of the delivery catheters. This study reports a single-center experience of totally percutaneous access during endovascular abdominal and thoracic aortic repairs using the Preclose Proglide device (Abbott Vascular, Redwood City, Calif). Between December 2004 and August 2006, 262 endovascular aortic aneurysm repairs were performed. Percutaneous access was used for the introduction of 12F to 24F sheaths (4.4-mm to 8.6-mm outer diameter). The technique involved deployment of two Proglide devices before insertion of the sheath ("Preclose" technique) with the sutures left extracorporeally for closure after conclusion of the procedure. A prospectively maintained endovascular database and medical records were retrospectively reviewed. Rates of technical success, failure modes, and the overall duration of the endovascular repair compared with a similar cohort using open femoral exposures were examined. A total of 559 Proglide devices were used to close 279 femoral arteries, and 175 (63%) required the insertion of 18F to 24F sheaths. There were 16 failures, mainly due to obesity, device malfunction, severe calcific disease, and faulty arterial punctures, for a technical success rate of 94.3%. The success rates for 12F to 16F size sheaths were significantly higher than for the larger 18F to 24F sheaths (99.0% vs 91.4%, P<.01). For both endovascular abdominal (EVAR) and thoracic (TEVAR) aortic repairs, the Preclose technique resulted in shorter overall procedure times compared with a similar cohort in which open femoral exposures were used (EVAR, 115 vs 128 min, P<.001; TEVAR, 80 vs 112, P=.019). Despite this reduction of procedure time, the savings on the cost of operating room time was negated by the cost of the Proglide devices ($295 per device). Percutaneous access for endovascular aortic repair is safe and feasible using the Proglide device. Although the success rates are higher for smaller size sheaths, successful closures may be obtained for up to 24F sheaths. Percutaneous access may result in shorter overall procedure times and potentially lower operating room costs, but this appears to be offset by the cost of the closure devices.
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                Author and article information

                Journal
                angiologia
                Angiología
                Angiología
                Arán Ediciones S.L. (Madrid, Madrid, Spain )
                0003-3170
                1695-2987
                June 2021
                : 73
                : 3
                : 119-124
                Affiliations
                [2] Burgos orgnameHospital Universitario de Burgos Spain
                [1] Marbella orgnameHospital Quirónsalud Marbella Spain
                [4] Granada orgnameHospital Universitario Clínico San Cecilio Spain
                [3] Oviedo orgnameHospital Universitario Central de Asturias Spain
                Article
                S0003-31702021000300002 S0003-3170(21)07300300002
                10.20960/angiologia.00193
                b24313b1-b38b-42cd-9025-fc516d0b8713

                This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.

                History
                : 16 July 2020
                : 29 March 2021
                Page count
                Figures: 0, Tables: 0, Equations: 0, References: 13, Pages: 6
                Product

                SciELO Spain

                Categories
                Originales

                Percutaneous complications,Aortic disease,Fragility,ProGlide,Preclose technique,TAVI,pEVAR,Complicaciones percutáneas,Enfermedad aórtica,Fragilidad,Técnica “preclose”,TAV

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