ABSTRACT
INTRODUCCIÓN: La patología traumática se encuentra entre las 5 principales causas de mortalidad, de ellas la hemorragia crítica traumática (HECTRA) es la principal causa de muerte evitable después de un traumatismo, suponiendo el 50% de las muertes en las primeras 24 horas. Según la base de datos RETRAUCI, aproximadamente un 6% de los pacientes ingresados en las UCI de Hospitales españoles por traumatismo presentan HECTRA, con una mortalidad hospitalaria del 35%. Teniendo en cuenta que esa mortalidad se refiere solo a los pacientes que ingresan en UCI, es muy probable que la mortalidad real de las HECTRA sea mucho mayor, si se incorporan los datos de muertes extrahospilatarias o en urgencias. El espectro de acretismo placentario (EAP) es una complicación obstétrica compleja asociada a una elevada morbilidad materna. Es un trastorno relativamente nuevo de la placentación, y es consecuencia de daños en la interfase endometrio-miometrio de la pared uterina. El EAP se produce en aproximadamente 1 de cada 1.000 partos. Estas cifras presentan variaciones importantes, probablemente debidas a la definición de la población de estudio, en función de la cual pueden oscilar entre el 0,04 al 0,9%. El EAP supone el 23% de las histerectomías periparto. El dispositivo REBOA (Balón endovascular resucitativo de oclusión aórtica) está compuesto por un catéter con un globo y la vaina de colocación. La colocación se realiza por inserción en arteria femoral. Una vez se ha inflado el globo del catéter REBOA de forma proximal a la lesión, se genera una obstrucción arterial que pretende evitar la hemorragia y mantener la irrigación mínima del cerebro, corazón y pulmones durante el tiempo necesario para que el paciente reciba atención sanitaria adecuada. Cuando REBOA es utilizada adecuadamente por profesionales con experiencia puede mejorar los resultados del subgrupo de pacientes con las lesiones más graves y las hemorragias más extensas. Los riesgos de REBOA incluyen la isquemia visceral total, la pérdida de miembros inferiores, la exacerbación de lesiones cerebrales traumáticas, la isquemia de la médula espinal, la pérdida rápida de sangre proximal y el efecto de lesión por reperfusión. En el caso del EAP, REBOA es una técnica preventiva alternativa y proporciona una oclusión más proximal. Esta técnica también se ha utilizado como complemento de la cirugía conservadora y tiene la ventaja de realizar un bloqueo adicional del riego de la placenta desde las arterias ilíacas externas, así como de detener el flujo en la arteria sacra media, lumbar baja y, en algunos casos, la arteria mesentérica inferior. REBOA se inserta con guía fluoroscópica antes del parto. Suele colocarse por debajo del origen de las arterias renales para evitar la isquemia de los riñones o las vísceras abdominales. El balón se inflaría tras el alumbramiento para prevenir la hemorragia. En España, la técnica REBOA se está utilizando cada vez más en hospitales especializados en cirugía traumática y en el tratamiento de pacientes con lesiones graves, del mismo modo que ha comenzado a utilizarse de modo preventivo en partos de mujeres con placenta acreta. OBJETIVO: Conocer la seguridad, efectividad y eficiencia de la técnica REBOA en pacientes con hemorragias abdominales, retroperitoneales y pélvicas o con espectro de acretismo placentario (EAP). METODOLOGÍA: Se ha realizado una revisión sistemática de la literatura científica disponible sobre efectividad, seguridad y eficiencia de REBOA en pacientes con hemorragia abdomino-pélvica traumática (REBOA terapéutica) o con EAP (REBOA preventiva). RESULTADOS: La RS llevada a cabo arrojó un resultado de 219 referencias de estudios, sin contar duplicados. De entre ellas se seleccionaron como fuente de partida 4 RS que permitieron restringir la búsqueda a aquellos estudios posteriores a las fechas de búsqueda de las mismas: febrero 2017 para REBOA preventiva en casos de EAP y mayo 2021 para REBOA terapéutica. Aplicando todos los criterios de cribado se seleccionaron, 6 estudios individuales posteriores a las revisiones mencionadas y uno más con análisis coste-utilidad. CONCLUSIONES: Reboa Terapéutica: La REBOA terapéutica resulta efectiva en la reducción de mortalidad a las 24 horas cuando se compara con toracotomía resucitativa (OR= 0,26; IC95%: 0,20 0,34). La certeza de la evidencia se valoró como baja. En general REBOA permite reducir la mortalidad hospitalaria respecto a cualquier comparador (OR= 0,90; IC95%: 0,81 0,99) (certeza de la evidencia muy baja). Especialmente en la comparación con TR (OR= 0,30; IC95%: 0,26 0,35), la certeza de la evidencia se valoró como moderada. REBOA también mejora la presión arterial sistólica tras la oclusión más que cualquier comparador (DM= 41,03 mmHg; IC95%: 36,77 45,29). La certeza de la evidencia se valoró como baja. REBOA es menos segura que sus comparadores en cuanto a amputación de extremidades inferiores, daño renal agudo, paraplejia, con una certeza de la evidencia baja y daño pulmonar agudo con una certeza de la evidencia calificada como muy baja. REBOA no resultaría eficiente según el único estudio identificado que se enmarca en el contexto del Reino Unido y que compara con toracotomía resucitativa. Reboa Preventiva: REBOA reduce el número de histerectomías cuando se utiliza como medida preventiva en partos de mujeres con espectro de acretismo placentario (EAP) (OR= 0,21; IC95%: 0,08 0,53). La certeza de la evidencia fue calificada como baja. La Reboa: preventiva también permite reducir el número de mujeres ingresadas en UCI (OR= 0,18; IC95%: 0,08 0,42) (certeza de la evidencia muy baja). Del mismo modo REBOA preventiva permite reducir las necesidades de transfusión y la duración de las intervenciones quirúrgicas de mujeres con EAP (certeza de la evidencia muy baja). REBOA preventiva no presenta más efectos adversos o complicaciones que sus comparadores (certeza de la evidencia muy baja).
INTRODUCTION: Traumatic pathology is among the 5 leading causes of mortality, of which traumatic critical haemorrhage (TCH) is the main cause of avoidable death after trauma, accounting for 50% of deaths in the first 24 hours. According to the RETRAUCI database, approximately 6% of the patients admitted to the ICU of Spanish hospitals for trauma present TCH, with a hospital mortality of 35%. Bearing in mind that this mortality refers only to patients admitted to the ICU, it is very likely that the real mortality of TCH is much higher if the data on deaths outside the hospital or in the emergency department are included. Placental accreta spectrum disorder (PAD) is a complex obstetric complication associated with high maternal morbidity. It is a relatively new disorder of placentation, resulting from damage to the endometrial-myometrial interface of the uterine wall. PAD occurs in approximately 1 in 1000 deliveries. These figures vary widely, probably due to the definition of the study population, depending on which may range from 0.04 to 0.9%. PAP accounts for 23% of peripartum hysterectomies. The REBOA device (Resuscitative Endovascular Balloon Aortic Occlusion) consists of a catheter with a balloon and delivery sheath. Placement is by insertion into the femoral artery. Once the balloon of the REBOA catheter is inflated proximal to the lesion, an arterial blockage is created to prevent bleeding and maintain minimal blood supply to the brain, heart and lungs for the time necessary for the patient to receive adequate care. When used properly by experienced professionals, REBOA can improve outcomes for the subgroup of patients with the most severe injuries and extensive bleeding. Risks of REBOA include total visceral ischaemia, lower limb loss, exacerbation of traumatic brain injury, spinal cord ischaemia, rapid proximal blood loss and reperfusion injury effect. In the case of PAD, REBOA is an alternative preventive technique and provides a more proximal occlusion. This technique has also been used as an adjunct to conservative surgery and has the advantage of additional blockage of the placental supply from the external iliac arteries, as well as stopping flow in the middle sacral, lower lumbar and, in some cases, the inferior mesenteric artery. REBOA is inserted under fluoroscopic guidance prior to delivery. It is usually placed below the origin of the renal arteries to avoid ischaemia of the kidneys or abdominal viscera. The balloon would be inflated after delivery to prevent haemorrhage. In Spain, the REBOA technique is increasingly being used in hospitals specialising in trauma surgery and in the treatment of patients with severe injuries, and has also begun to be used preventively in the delivery of women with PAD. OBJECTIVE: To determine the safety, effectiveness and efficiency of the REBOA technique in patients with abdominal, retroperitoneal and pelvic haemorrhage or with PAD. METHODOLOGY: A systematic review of the available scientific literature on the effectiveness, safety and cost-effectiveness of REBOA in patients with traumatic abdomino-pelvic haemorrhage (therapeutic REBOA) or with PAD (preventive REBOA) was carried out. RESULTS: The SR carried out yielded 219 study references, excluding duplicates. Of these, 4 SR were selected as a starting source, which allowed us to restrict the search to those studies after their search dates: February 2017 for preventive REBOA in cases of PAD and May 2021 for therapeutic REBOA. Applying all the screening criteria, 6 individual studies were selected after the aforementioned reviews and one more with cost-utility analysis. CONCLUSIONS: Therapeutic Reboa: Therapeutic REBOA is effective in reducing 24-hour mortality when compared to resuscitative thoracotomy (OR= 0.26; 95%CI: 0.20 0.34). The certainty of the evidence was assessed as low. Overall, REBOA reduces in-hospital mortality compared to any comparator (OR= 0.90; 95%CI: 0.81 0.99) (very low certainty of evidence). Especially in the comparison with TR (OR= 0.30; 95%CI: 0.26 0.35), the certainty of evidence was assessed as moderate. REBOA also improves systolic blood pressure after occlusion more than any comparator (MD= 41.03 mmHg; 95% CI: 36.77 45.29). The certainty of the evidence was assessed as low. REBOA is less safe than its comparators in terms of lower limb amputation, acute kidney damage, paraplegia with a certainty of evidence rated as low. and acute lung damage, with a certainty of evidence rated as very low. REBOA wouldn't be efficient according to the only identified study in the UK context comparing with TR. Preventive Reboa: REBOA reduces the number of hysterectomies when used as a preventive measure in deliveries of women with PAD (OR= 0.21; 95%CI: 0.08 0.53). Certainty of evidence rated as low. Preventive REBOA also reduces the number of women admitted to the ICU (OR= 0.18; 95%CI: 0.08 0.42) (certainty of evidence very low). Similarly, preventive REBOA reduces transfusion requirements and the duration of surgery for women with PAD (certainty of evidence very low). Preventive REBOA has no more adverse effects or complications than its comparators (certainty of evidence very low).
Subject(s)
Humans , Aortic Diseases/surgery , Resuscitation/methods , Endovascular Aneurysm Repair/methods , Health Evaluation/economics , Cost-Benefit Analysis/economicsABSTRACT
INTRODUCCIÓN Un aneurisma arterial es una dilatación patológica de una arteria. Se produ cen por degeneración de la pared arterial, que conlleva su adelgazamiento y posterior debilitamiento, con una pérdida de su resistencia a la tracción, aumentando por tanto su vulnerabilidad a los aumentos de presión intravas cular. Pueden ser congénitos o adquiridos, generalmente por aterosclerosis, infecciones, vasculitis o traumatismos. Fuera del cerebro, las localizaciones más frecuentes son la aorta abdominal y la torácica, y en miembros inferio res la arteria poplítea y la femoral común. El aneurisma aórtico es una importante causa de muerte en España. Los aneurismas aórticos se presentan con más frecuencia en varones y en la porción abdominal de la aorta. En los últimos años las técnicas endovasculares para el tratamiento de aneurismas aórticos (EVAR/TEVAR) suponen una alternativa a la cirugía abierta tradicional, con menor morbimortalidad temprana e infe rior estancia hospitalaria. Su indicación depende de la anatomía arterial del pa
INTRODUCTION An arterial aneurysm is a pathological dilatation of an artery. They are caused by degeneration of the arterial wall, which leads to thinning and sub sequent weakening, with a loss of its resistance to traction, thus increasing its vulnerability to increases in intravascular pressure. They may be congenital or acquired, usually due to atherosclerosis, infection, vasculitis or trauma. Outside the brain, the most frequent locations are the abdominal and tho racic aorta, and in the lower limbs the popliteal and common femoral arter ies. Aortic aneurysm is a major cause of death in Spain. Aortic aneurysms occur more frequently in men and in the abdominal portion of the aorta. In recent years, endovascular techniques for the treatment of aortic aneurysms (EVAR/TEVAR) represent an alternative to traditional open surgery, with lower early morbidity and mortality and shorter hospital stay. Their indication depends on the patient's arterial anatomy. There is a high er risk of migration/endoleak when the patient has an abdominal aortic aneurysm with a hostile neck (marked angulation, short length, complex shape, wide diameter or presence of calcification or thrombus). In thoracic aortic aneurysms, an anatomical feature to consider is the proximal neck diameter. Anchoring systems to increase adhesion and fixation of the endograft to the aortic wall used in endovascular procedures for aortic aneurysm re pair are an alternative therapeutic approach to open surgery. OBJECTIVES The aim of this document is to provide the Spanish National Health System (SNHS) with sound information on the effectiveness and safety of the pro phylactic or therapeutic use of an anchoring system in endovascular aortic aneurysm repair (EVAR/TEVAR) procedures. METHODS Adaptation to the Spanish context of the evaluation report on endoanchoring systems in endovascular repair of aortic aneurysms "Agencia de Evaluación de Tecnologías Sanitarias-AETS-ISCIII, Republika Slovenija Ministrstvo za Zdravjel. Prophylactic or therapeutic use of endoanchoring systems in endo vascular aortic aneurysm repair (EVAR/TEVAR). Collaborative Assessment: EUnetHTA; 2019. Report No.: OTCA20." [1], developed by a European team led by the Agency for Health Technology Assessment of the Institute of Health Carlos III (AETS-ISCIII). The structure of this document is based on the "Guide for the prepara tion and adaptation of rapid health technology assessment reports" [2] of the Spanish Network of Health Technology Assessment Agencies. Evidence was retrieved from a systematic literature search initial ly up to April 2019, updated for this document to September 2020 with no new studies identified, following a predefined strategy in PubMed, MEDLINE, EMBASE, Cochrane Central Register of Controlled Tri als and the Cochrane Database for Systematic Reviews, as well as after hand searching references of selected studies and queries to manufac turers. Literature selection and data extraction were peer-reviewed. The GRADE (Grading of Recommendations, Assessment, Development and Evaluation) methodology [3] was used for evidence assessment. The risk of bias assessment tool used was the IHE-20 checklist for case series (single-arm studies) [4]. RESULTS The literature search yielded 441 references. The final selection provided 11 studies with a total of 684 patients. 10 studies were prospective case series (one of them with propensity-matched retrospective controls and one study was a retrospective case series). All studies were included in the effective ness analysis and 8 studies were included in the safety analysis. The quality of evidence was rated very low in all selected studies [1]. The variability of the follow-up (from less than a year to 48 months) for most of the outcomes, and not always well specified time points of the events, limited the analysis. Also, not all had computed tomography imaging results in their follow-up records. Sample sizes were small for those patients with secondary interventions and with TEVAR. Patients who underwent a primary intervention due to prophylaxis (prophylactic group) were the most studied group, although this sample, when pooled, numbered less than 400 patients and not all had at least one year of follow-up. This may cause that late outcomes were not yet occurring, e.g., reinterventions due to complica tions. The risk of endograft complications at the proximal neck increased over time, with endoleaks and migration more commonly arising as a longer term problem. In regards to the safety of the intervention, most of the adverse events were presented and analysed as a pooled total (not per subgroup) due to the difficulty of extracting and/or calculating by subgroups in most of the studies included in the safety domain. The only registered trial (ANCHOR) ongoing in 2018 reported the following comparative 1-, 2- and 3-year results for the occurrence of type 1a endoleaks: 0.6%, 1.1% and 1.7%, respectively, for the primary arm, and 7.9%, 5.9% and 2.4%, respectively, for the revision arm. No cases of endograft migration were reported in the primary interven tion or in the revision arm (secondary intervention) in AAA patients. The only control data involved a cohort of 99 patients obtained by propensity matching that reported the rate of complications (migration or endoleaks), although there were no significant differences with the intervention-free control group. Procedure-related mortality in EVAR patients was one of the most evaluated safety outcomes in the 8 included studies, with a rate close to 0% at 30-day follow-up. This rate was 3.7% in the only TEVAR study in cluded. The rate of stroke (considered as procedure-related morbidity), low in this case series, was more frequently associated with TEVAR procedures and EVAR procedures than with open surgery at short or mid-term follow up periods [1]. For patients in the prophylaxis group with abdominal aneurysms, the aneurysm-related mortality rate at 30 days was 0.25%. The aneurysm-relat ed mortality rate at one year was 0.26%. For patients with thoracic aneu rysms, the aneurysm-related mortality rate at 30 days was 3.7% and 9.3% at one year. No deaths related to aneurysm were reported in cases requiring a secondary intervention [1]. Regarding ruptured aneurysms, in patients with abdominal aneurysms and primary intervention, no cases were reported during 48-month follow up period. In patients who underwent a secondary intervention, no aneu rysms ruptures were reported. For thoracic aneurysms the rupture rate was 1.9%. Regarding the reintervention rate, a 9.7% was estimated in patients with primary intervention and abdominal aneurysms. For thoracic aneu rysms, a 16.7% has been informed. The rate of recurrence of complications estimated in patients with prophylactic intervention and abdominal aneu rysm was 2.5%. In patients with secondary intervention and abdominal an eurysm a rate of recurrence of complications of 13.63%was estimated. In patients with thoracic aneurysm a rate of recurrence of complications of 7.4% was estimated. Overall mortality appeared to be inferior in the primary prophylactic intervention group compared to the secondary intervention group, probably because the intervention was not determined by the presence of previous complications. It was also low in the secondary intervention groups, how ever, this may be a reflection of the small sample size and brief follow-up period. Nevertheless, in the latter case, those patients whose interventions were due to type I endoleaks had the highest rate of mortality at one year within the secondary setting (7%). The highest mortality rates at one year were recorded by the thoracic study and the retrospective series on primary patients (all kinds) (11% and 13%, respectively) [1]. CONCLUSIONS In terms of effectiveness, again the evidence precludes any firm conclusions as to whether the use of endoanchors in EVAR/TEVAR procedures results in better outcomes. Globally, the information compiled on critical outcomes (rate of type I endoleaks or migration, rate of reintervention, rate of aneu rysm rupture or rate of aneurysm-related mortality), although of very low quality, would suggest effectiveness of the device. Nonetheless, evidence from high-quality comparative studies remains lacking. Results should be compared with treatment regimens without the Heli-FX™ EndoAnchor™ system in randomised controlled trials for most of the critical and important outcomes. With regard to safety, based on the results from observational studies, and within the limitations of the low-quality evidence available, the data suggest that the use of Heli-FX™ EndoAnchor™ in EVAR patients (pro phylactically or as part of endograft migration or type I endoleak treatment) would be safe in the midterm follow-up for those presenting unfavourable neck anatomy and probably safe over long-term follow-up for those with friendly neck anatomies. However, comparative data on standard endovas cular therapy are not currently available. We cannot form any conclusions regarding the safety of Heli-FX™ EndoAnchor™ in TEVAR patients.