A randomized controlled noninferiority trial comparing radiofrequency with stripping and conservative hemodynamic cure for venous insufficiency technique for insufficiency of the great saphenous vein.

OBJECTIVE: The quality of available evidence regarding new minimally invasive techniques to abolish great saphenous vein reflux is moderate. The present study assessed whether radiofrequency ablation (RFA) was noninferior to high ligation and stripping (HLS) and conservative hemodynamic cure for venous insufficiency (CHIVA) for clinical and ultrasound recurrence at 2 years in patients with primary varicose veins (VVs) due to great saphenous vein (GSV) insufficiency. METHODS: We performed a randomized, single-center, open-label, controlled, noninferiority trial to compare RFA and 2 surgical techniques for the treatment of primary VVs due to GSV insufficiency. The noninferiority margin was set at 15% for absolute differences. Patients aged >18 years with primary VVs and GSV incompetence, with or without clinical symptoms, C2 to C6 CEAP (Clinical, Etiologic, Anatomic, Pathophysiologic) clinical class, and GSV diameter >4 mm were randomized with a 1:1:1 ratio to RFA, HLS, or CHIVA. The rate of clinical recurrence at 24 months was the primary endpoint and was analyzed using a delta noninferiority margin of 15%. Ultrasound recurrence, safety, and quality of life were secondary endpoints. RESULTS: From December 2012 to June 2015, 225 limbs had been randomized to RFA, HLS, or CHIVA (n = 74, n = 75, and n = 76). Clinical follow-up and Doppler ultrasound examinations were performed at 1 week and 1, 6, 12, and 24 months postoperatively. No differences in postoperative complications or pain were observed among the three groups. RFA was noninferior to HLS and CHIVA for clinical recurrence at 24 months, with an estimated difference in recurrence of 3% (95% confidence interval [CI], -4.8% to 10.7%; noninferiority P = .002) and -7% (95% CI, -17% to 3%; P < .001), respectively. For ultrasound recurrence, RFA was noninferior to CHIVA, with an estimated difference of -34% (95% CI, -47% to -20%; noninferiority P < .001) at 24 months. However, noninferiority could not be demonstrated compared with HLS (5.9%; 95% CI, -4.1 to 15.9; P = .073). No differences were found in quality of life among the three groups. CONCLUSIONS: RFA was shown to be noninferior in terms of clinical recurrence to HLS and CHIVA in the treatment of VVs due to GSV insufficiency.

Drug-Coated Balloon Angioplasty in Clinical Practice for Below-the-Knee, Popliteal, and Crural Artery Lesions Causing Critical Limb Ischemia: 1-Year Results from the Spanish Luminor Registry.

BACKGROUND: Luminor is a new drug-coated angioplasty balloon, which is approved by the European Conformity market. The aim of the present study is to analyze the 1-year results, in terms of effectiveness and safety, of the Luminor® 14/14M and 35 drug-coated balloons (iVascular, Sant Vicenç dels Horts, Barcelona, Spain) in a special cohort of critical limb ischemia (CLI) of the Luminor registry. METHODS: Luminor is phase IV, nonrandomized, prospective, observational, and multicenter clinical study. The present study includes patients with CLI to analyze the effectiveness, in terms of primary patency, and the safety defined by the major adverse effects: any cause mortality, major amputation, and/or clinically driven target lesion revascularization (TLR). Both femoropopliteal and below-the-knee infrapopliteal lesions were treated. All the end points were assessed after the procedure, at 30 days, 6 and 12 months thereafter. RESULTS: About 148 patients (101 males; mean age, 73.2 ± 11.4 years) with CLI were included. About 83.3% were classified as Rutherford's class 5. Diabetes mellitus was diagnosed in 71.6%; hypertension, hyperlipidemia, renal insufficiency, and coronary disease were present in 87.2%, 57.4%, 29.7%, and 39.2% of the sample, respectively. The average follow-up was 11.2 ± 3.27 months. The primary patency and the freedom of clinically driven TLR, at 1 year, were 87.7% and 92.1%, respectively. Survival and freedom from major amputations were 85.1% and 84.7%, respectively. CONCLUSIONS: Even with a very sick population, the results at 12 months are highly satisfactory with reference to survival, freedom from amputation, patency, and the absence of reintervention.

Spanish Clinical Guidelines on Vascular Access for Haemodialysis. / Guía Clínica Española del Acceso Vascular para Hemodiálisis.

Vascular access for haemodialysis is key in renal patients both due to its associated morbidity and mortality and due to its impact on quality of life. The process, from the creation and maintenance of vascular access to the treatment of its complications, represents a challenge when it comes to decision-making, due to the complexity of the existing disease and the diversity of the specialities involved. With a view to finding a common approach, the Spanish Multidisciplinary Group on Vascular Access (GEMAV), which includes experts from the five scientific societies involved (nephrology [S.E.N.], vascular surgery [SEACV], vascular and interventional radiology [SERAM-SERVEI], infectious diseases [SEIMC] and nephrology nursing [SEDEN]), along with the methodological support of the Cochrane Center, has updated the Guidelines on Vascular Access for Haemodialysis, published in 2005. These guidelines maintain a similar structure, in that they review the evidence without compromising the educational aspects. However, on one hand, they provide an update to methodology development following the guidelines of the GRADE system in order to translate this systematic review of evidence into recommendations that facilitate decision-making in routine clinical practice, and, on the other hand, the guidelines establish quality indicators which make it possible to monitor the quality of healthcare.

Guía Clínica Española del Acceso Vascular para Hemodiálisis / Spanish Clinical Guidelines on Vascular Access for Haemodialysis

El acceso vascular para hemodiálisis es esencial para el enfermo renal tanto por su morbimortalidad asociada como por su repercusión en la calidad de vida. El proceso que va desde la creación y mantenimiento del acceso vascular hasta el tratamiento de sus complicaciones constituye un reto para la toma de decisiones debido a la complejidad de la patología existente y a la diversidad de especialidades involucradas. Con el fin de conseguir un abordaje consensuado, el Grupo Español Multidisciplinar del Acceso Vascular (GEMAV), que incluye expertos de las cinco sociedades científicas implicadas (nefrología [S.E.N.], cirugía vascular [SEACV], radiología vascular e intervencionista [SERAM-SERVEI], enfermedades infecciosas [SEIMC] y enfermería nefrológica [SEDEN]), con el soporte metodológico del Centro Cochrane Iberoamericano, ha realizado una actualización de la Guía del Acceso Vascular para Hemodiálisis publicada en 2005. Esta guía mantiene una estructura similar, revisando la evidencia sin renunciar a la vertiente docente, pero se aportan como novedades, por un lado, la metodología en su elaboración, siguiendo las directrices del sistema GRADE con el objetivo de traducir esta revisión sistemática de la evidencia en recomendaciones que faciliten la toma de decisiones en la práctica clínica habitual y, por otro, el establecimiento de indicadores de calidad que permitan monitorizar la calidad asistencial (AU)

Vascular access for haemodialysis is key in renal patients both due to its associated morbidity and mortality and due to its impact on quality of life. The process, from the creation and maintenance of vascular access to the treatment of its complications, represents a challenge when it comes to decision-making, due to the complexity of the existing disease and the diversity of the specialities involved. With a view to finding a common approach, the Spanish Multidisciplinary Group on Vascular Access (GEMAV), which includes experts from the five scientific societies involved (nephrology [S.E.N.], vascular surgery [SEACV], vascular and interventional radiology [SERAM-SERVEI], infectious diseases [SEIMC] and nephrology nursing [SEDEN]), along with the methodological support of the Cochrane Center, has updated the Guidelines on Vascular Access for Haemodialysis, published in 2005. These guidelines maintain a similar structure, in that they review the evidence without compromising the educational aspects. However, on one hand, they provide an update to methodology development following the guidelines of the GRADE system in order to translate this systematic review of evidence into recommendations that facilitate decision-making in routine clinical practice, and, on the other hand, the guidelines establish quality indicators which make it possible to monitor the quality of healthcare (AU)

A Prospective, Randomized, Multicenter Clinical Trial on the Safety and Efficacy of a Ready-to-Use Fibrin Sealant as an Adjunct to Hemostasis during Vascular Surgery.

BACKGROUND: Anastomotic or "stitch hole" bleeding is common during vascular surgery with synthetic material such as Dacron or polytetrafluoroethylene. Hemostatic adjuncts such as fibrin sealant (FS) may reduce blood loss and operating time in such circumstances. We evaluated the safety and the hemostatic effectiveness of a ready-to-use human plasma-derived FS in vascular surgery. METHODS: Patients with mild/moderate suture line bleeding during elective, open, vascular surgery using synthetic grafts or patches were studied. In an initial Exploratory Study, all patients were treated with FS Grifols, and in a subsequent Primary Study were randomized in a 2:1 ratio to FS Grifols or manual compression (MC). The primary efficacy end point was time to hemostasis (TTH), assessed at defined intervals from the start of treatment application, during a 10-min observational period. Safety end points (in Exploratory + Primary Studies) included adverse events (AEs), vital signs, physical assessments, common clinical laboratory tests (coagulation, complete blood count, serum clinical chemistry parameters, microscopic urinalysis), viral markers, and immunogenicity. RESULTS: In the Primary Study, the proportion of patients who achieved hemostasis at the 3-min time point was higher in the FS Grifols group (46.4%, n = 51/110) than in the MC group (26.3%, n = 15/57) (P < 0.05). The benefit was maintained at successive time intervals: 69 FS Grifols patients (62.7%) and 18 MC patients (31.6%) at 4 min; 82 FS Grifols patients (74.5%) and 28 MC patients (49.1%) at 5 min. The differences between the groups persisted for TTH ≤ 7 min and TTH ≤ 10 min. Treatment failure was reported for 13 FS Grifols patients (11.8%) and 16 MC patients (28.1%). TTH was shorter after FS Grifols application than after MC application. Differences were statistically significant in favor of FS Grifols for each TTH category and for the overall comparison (P < 0.001) as well as for each TTH category (cumulative) and for treatment failure (P = 0.016). Overall, AE experience and types of AEs reported were those expected in this patient population and were similar between the 2 treatment groups. The most frequently reported AEs were procedural pain (59.9% and 69.2% of patients in the FS Grifols [n = 72 + 111] and MC [n = 57] groups, respectively) and nausea (23.5% and 19.2% of patients, respectively). CONCLUSIONS: FS Grifols was efficacious and safe as an adjunct to anastomotic hemostasis in patients undergoing arterial surgery using prosthetic material with mild to moderate bleeding.

Could Preoperative Neck Anatomy Influence Follow-up of EVAR?

BACKGROUND: The aim of the study was to assess the clinical utility of strict CT scan surveillance after endovascular abdominal aneurysm repair (EVAR) and evaluate whether the anatomy of abdominal aortic aneurysm (AAA) neck (favorable/hostile) influences regular imaging control. METHODS: A retrospective study of AAA patients who underwent EVAR with aortobi-iliac endoprostheses during 2006-2013 was conducted. Exclusion criteria included other types of devices. Variables analyzed were technical and clinical success, morbimortality, complications (such as endoleaks, sac enlargement), reinterventions, reintervention-free survival, and survival rate. Preoperative CT scans were performed and repeated at 1, 6 (in selective cases), 12, and 24 months postoperatively. Patients were divided into two groups according to preoperative anatomic characteristics: group I (favorable neck) and group II (hostile neck: angle > 60°, length < 15 mm, diameter > 28 mm, and calcification or circumference thrombus ≥50%). RESULTS: A total of 127 patients with AAA (96.8% male) were included in the study. The mean age of the patients was 75.9 years (range: 51-90 years). The mean AAA diameter was 62.1 mm. Hostile neck was found in 52 patients (40.9%). The technical and clinical success rate was 100% and 30-day mortality was 0.8%. The reintervention-free survival rate was 97.6%, 96.1%, and 93.7% and the survival rate was 97.6%, 96.9%, and 91.3%, during follow-up at 6, 12, and 24 months, respectively. Accumulated complications in proximal sealing occurred in 0%, 0%, and 1.6% in group I and 1.9%, 6.1%, and 7.7% in group II at 1, 12, and 24 months, respectively. Type II endoleaks occurred in 24.3%, 14.3%, and 11.4% in group I and 9.8%, 6.3%, and 6.8% in group II at 1, 12, and 24 months, respectively. No increased diameter was detected at 6 and 12 months. No differences were observed in reinterventions and mortality rate depending on anatomy. CONCLUSIONS: CT scans performed at 6 and 12 months postoperatively did not detect complications or need for reintervention in patients with favorable necks, even in the presence of endoleaks type II, and could therefore be omitted. Hostile necks may compromise proximal sealing and require regular imaging follow-ups.

Study to develop a waiting list prioritization score for varicose vein surgery.

BACKGROUND: The objective of this study was to develop a clear-cut, objective system for prioritization of patients on the waiting list for varicose vein surgery, to enable organization of access to the health service. METHODS: During earlier phases, we selected which variables should be taken into account for the prioritization scale, such as clinical presentation, varicose vein size, complications, work situation, and influence on quality of life. In the last phase, to determine the relative weight of each variable, structured surveys (personal interviews or by e-mail) were performed of the convenience samples from the groups related to the healthcare process, including patients, relatives, and healthcare professionals. RESULTS: The structured survey we utilized was administered to a sample of 762 subjects that included 290 patients, 99 relatives, 179 general practitioners, 32 nurses, and 162 vascular surgeons. The final score included clinical manifestations (46.1% of relative importance), size of the varicose veins (8.2%), complications (18.3%), influence on quality of life (18.2%), and aggravating work factors (9.2%). CONCLUSIONS: The prioritization system agreed upon by all the groups involved could allow for objective and transparent prioritization and lead to the rationalization of access to varicose vein surgery for patients on the waiting list.

Monitoring the practice of vascular surgery: findings from a national registry (1996-2011).

BACKGROUND: The goal of this article is to present for the first time to the international community the detailed findings and outcomes of the Spanish Vascular Registry (SVR) after 16 years of experience. METHODS: We examined the nationwide registry promoted by the Spanish Society of Angiology and Vascular Surgery (1996-2011). The changes in vascular surgical activity in Spain during the period of study were examined. We evaluated the number of services, medical specialists, consultations, admissions, and operations that occurred in Spain. We also assessed the trends in therapeutic activity and the medical and social impact of vascular pathology. RESULTS: A mean of 60 centers (range = 32-83) participated in the SVR (79.3 % of the total). In the last year of the study period, 94.3 % centers (100 % of teaching centers) participated. The mean number of activities per hospital per year was 5,298 consultations, 2,625 vascular explorations, 630 hospital admissions (61 % elective and 31 % emergency), and 742 surgical procedures. A total of 29,289 carotid stenosis procedures had been registered over 16 years. Both carotid endarterectomy (CEA) and carotid artery stenting (CAS) procedures have increased in frequency over time. In 2011, CAS constituted 19.3 % of all carotid procedures. A total of 31,703 abdominal aortic aneurysm (AAA) operations were registered during the study period. Surgery for ruptured AAA remained stable over time. Since its appearance in the year 2000, endovascular treatment (EVAR) increased steadily over time. Currently, EVAR represents about half of all AAA surgery (50.2 %). The total rate of in-hospital operative deaths was 1.1 %, but in-hospital mortality for open arterial surgery was 4 %. Mortality has decreased of late. CONCLUSIONS: The SVR has enabled us to understand the development and implementation of vascular surgery throughout Spain and to note the increased healthcare activity and the better overall results obtained as a consequence.

Ruptura aórtica abdominal espontánea por úlcera penetrante tratada mediante reparación endovascular / Treatment of spontaneous abdominal aortic rupture due to a penetrating ulcer by means of endovascular repair

Introducción. La úlcera penetrante aórtica se define como una lesión arterioesclerosa con ulceración de la íntima y media aórticas, con ruptura de la lámina elástica interna, que se localiza predominantemente en la aorta torácica; es infrecuente su localización en la aorta abdominal. La llegada de las técnicas endovasculares ha incrementado las posibilidades terapéuticas. Caso clínico. Varón de 77 años, que acudió a Urgencias por dolor abdominal y anemia progresiva. La tomografía computarizada mostraba una ruptura aórtica abdominal con fuga de contraste 1 cm por debajo del ostium de la arteria renal derecha, así como la presencia de pseudoaneurisma de 5 cm en el espacio subdiafragmático. Como tratamiento de urgencia se decidió la colocación de una endoprótesis aortouniilíaca con oclusor ilíaco derecho y bypass femorofemoral izquierda-derecha, excluyendo la arteria renal izquierda para el correcto sellado proximal. El paciente se estabilizó hemodinámicamente, pero falleció a los 97 días por fallo multiorgánico. La autopsia confirmó la correcta situación de la endoprótesis, sin fugas e integrada en la pared aórtica. Conclusión. La úlcera penetrante aórtica abdominal es una lesión potencialmente mortal por el elevado riesgo de ruptura. El tratamiento endoluminal constituye una opción terapéutica menos agresiva, que puede disminuir las tasas de morbimortalidad en pacientes de alto riesgo

Introduction. A penetrating aortic ulcer is defined as an arteriosclerotic lesion with ulceration of the aortic tunica intima and media, with rupture of the internal elastic lamina, which is predominantly located in the thoracic aorta; it is infrequently found in the abdominal aorta. The advent of endovascular techniques has brought with it an increase in the number of therapeutic possibilities available. Case report. A 77-year-old male, who visited the Emergency department with abdominal pain and progressive anaemia. A computerised tomography scan revealed the presence of a rupture of the abdominal aorta with contrast leak 1 cm below the ostium of the right renal artery, together with the presence of a 5-cm pseudoaneurysm in the subdiaphragmatic space. Emergency treatment consisted in placement of an aortouniiliac stent with right iliac occlusion and left-right femorofemoral bypass, with exclusion of the left renal artery in order to achieve proper proximal sealing. The patient became haemodynamically stable, but died at 97 days due to multiple organ failure; the autopsy confirmed correct location of the stent, with no leaks, and it was integrated within the wall of the aorta. Conclusions. Penetrating abdominal aortic ulcer is a potentially fatal lesion due to the high risk of rupture. Endoluminal treatment constitutes a less aggressive therapeutic option that can lower the morbidity and mortality rates in high risk patients

Estudio de calidad de vida en pacientes afectos de isquemia crítica a medio plazo / Study of the medium term quality of life in patients with critical ischaemia

Introducción. El tratamiento de la isquemia crítica de extremidades inferiores tiene por finalidad el salvamento de la extremidad, la resolución de los síntomas y la mejora en la calidad de vida. Objetivo. Determinar diferencias en términos de calidad de vida en pacientes con isquemia crítica y que se revascularizan con éxito (grupo I), y aquellos sin posibilidad revascularizadora, amputados o con trombosis del bypass durante el seguimiento (grupo II). Pacientes y métodos. Seleccionamos una muestra aleatoria de 48 pacientes con isquemia crítica. Aplicamos el test SF-36 al primer y segundo año y evaluamos la permeabilidad, salvamento de la extremidad y la mortalidad. Resultados. La supervivencia global al primer y segundo año fue del 79% y 56%, respectivamente, con una permeabilidad para la cirugía del 94% y 86% y un salvamento de extremidad del 100%, excluidas las amputaciones primarias. No encontramos diferencias en ninguno dominio del SF-36 entre ambos grupos al primer y segundo año. La media de supervivencia global fue de 26 meses. Conclusiones. La calidad de vida a medio plazo en los pacientes revascularizados no difiere de los no revascularizados, amputados o con trombosis del bypass. El dolor y la limitación física así como los múltiples factores de comorbilidad presentes en estos pacientes implican un pronóstico pobre en términos de calidad de vida a pesar de los tratamientos realizados

Introduction. The purpose of treatment of critical ischaemia of the lower extremities is to salvage the limb, resolve the symptoms and improve the patient’s quality of life. Aim. To determine the differences, as far as quality of life is concerned, between patients with critical ischaemia who undergo successful revascularisation (group I) and those who cannot be revascularised, have suffered amputation or in whom a thrombosis was observed in the bypass during follow-up (group II). Patients and methods. We selected a random sample of 48 patients with critical ischaemia. The SF-36 test was applied at one and two years and patency, limb salvage and mortality rates were evaluated. Results. Overall survival at one and two years was 79% and 56%, respectively, with 94% and 86% patency for surgery, and a limb salvage rate of 100%, excluding primary amputations. No differences were found between the two groups at one and two years in any of the areas of the SF-36. Overall mean survival time was 26 months. Conclusions. There is no difference between the medium term quality of life in revascularised patients and those who have not undergone revascularisation, have suffered amputation or who have a thrombosed bypass. The pain and physical limitations, as well as the multiple comorbidity factors that these patients have, imply a poor prognosis in terms of quality of life despite the treatments that are carried out