Multicenter study of the safety and effectiveness of intracranial aneurysm treatment with the p64MW-HPC flow modulation device.

BACKGROUND AND PURPOSE: The new p64 flow diverter with hydrophilic polymer coating (HPC) was designed to reduce thrombogenicity. To date, it is unclear how antithrombogenic surface modifications affect neoendothelialization and thrombus formation in patients with unruptured intracranial aneurysms. The purpose of this study was to evaluate the safety and effectiveness of the p64MW-HPC in the treatment of unruptured aneurysms of small to giant size and of both the anterior and posterior circulation. MATERIALS AND METHODS: Between March 2020 and October 2022 all patients with unruptured intracranial aneurysms treated with the p64MW-HPC were included at five neurovascular centers. Demographic data, aneurysm characteristics, antiplatelet therapy, procedural complications, and clinical and angiographic outcomes were recorded. RESULTS: A total of 100 patients with 100 unruptured intracranial aneurysms met the inclusion criteria. Eighty-three aneurysms were classified as saccular, 12 aneurysms were fusiform, 4 aneurysms dissecting, and 1 aneurysm was blister-like. Dual antiplatelet therapy with Clopidogrel and Aspirin was given in 68 cases, and with Ticagrelor and Aspirin in 24 cases. Technical issues with deployment were encountered in 14 cases (torsion (n = 3), foreshortening (n = 8), and incomplete opening (n = 3)). Ischemic stroke occurred in a total of seven cases. In one patient a wire perforation and subsequent severe ICH occurred. Complete aneurysm occlusion at angiographic follow-up (mean time = 7 months) was seen in 73% and adequate occlusion in 93%. CONCLUSION: This study is the largest multicenter study to date documenting the safety and effectiveness of the new antithrombogenic p64MW-HPC in the treatment of unruptured intracranial aneurysms of the anterior and posterior circulation.

Afrontamiento psicológico en pacientes mujeres con cáncer de mama de un hospital de Lima Metropolitana / Psychological coping in female breast cancer patients from a Metropolitan Lima hospital

Objetivos. Comprender el afrontamiento psicológico en pacientes mujeres con cáncer de mama de un hospital de Lima Metropolitana. Materiales y métodos. La investigación siguió un enfoque cualitativo con un diseño de análisis temático reflexivo. Se entrevistó a 16 mujeres con cáncer de mama entre los 35 y 65 años. El análisis de datos se realizó con apoyo del software ATLAS.ti 22. Resultados. Se presentaron tres estrategias de afrontamiento psicológico: afrontamiento emocional, el cual se encontró con mayor intensidad, y comprende el apoyo de personas significativas, el afrontamiento religioso y la concentración en las consecuencias positivas, generando una reinterpretación positiva y la aceptación progresiva de la enfermedad; el afrontamiento resolutivo, caracterizado por la acción diligente, con seguimiento a las indicaciones, y la búsqueda de apoyo profesional. Finalmente, el afrontamiento evasivo, se centró en los elementos negativos, el aplazamiento del afrontamiento y la distracción cognitiva y conductual, siendo este último de suma relevancia para equilibrar las actividades en la vida cotidiana de las pacientes. Conclusiones. Las mujeres emplearon con mayor frecuencia estrategias del estilo emocional, ya que intentan incrementar las emociones positivas, acompañado del apoyo religioso y del entorno; además, utilizaron estrategias relacionadas al estilo resolutivo, puesto que centraron sus acciones para recibir la atención y tratamiento médico, dejando de lado otras actividades; pese a ello, emplearon estrategias para desenfocarse del padecimiento y así desligarse de sus preocupaciones.

Objective. To understand the psychological coping strategies in female patients with breast cancer from a hospital in Metropolitan Lima. Materials and methods. This was a qualitative research with a reflexive thematic analysis design. Sixteen women with breast cancer between 35 and 65 years of age were interviewed. Data was analyzed with the ATLAS.ti 22 software. Results. Three psychological coping strategies were described: emotional coping, which was found more frequently, includes the support of important people, religious coping, and focusing on positive consequences, which leads to a positive reinterpretation and progressive acceptance of the disease; active coping, characterized by diligent action, following indications, and seeking professional support. Finally, avoidance coping, which focuses on negative elements, postponement of the coping process and cognitive and behavioral distractions, the latter being of utmost relevance to balance the activities in the patients' daily lives. Conclusions. Participants used emotional coping strategies more frequently, since they tried to increase positive emotions, accompanied by religious and environmental support. In addition, they also used active coping strategies, since they focused their actions to receive medical attention and treatment, leaving aside other activities; in spite of this, they used strategies to take their focus off the condition and thus detach themselves from their worries.

Psychological coping in female breast cancer patients from a Metropolitan Lima hospital. / Afrontamiento psicológico en pacientes mujeres con cáncer de mama de un hospital de Lima Metropolitana.

OBJECTIVE.: Motivation for the study: it is important to identify the coping strategies used by women with breast cancer, in order to contribute to their physical and emotional well-being. Main findings: strategies related to the emotional sphere are used to a greater extent, and also lead to progressive acceptance of the disease. Cognitive and behavioral distractions are necessary to balance patients' daily activities. Implications: understanding how women face this disease allows the development of primary care strategies to improve their wellbeing. To understand the psychological coping strategies in female patients with breast cancer from a hospital in Metropolitan Lima. MATERIALS AND METHODS.: This was a qualitative research with a reflexive thematic analysis design. Sixteen women with breast cancer between 35 and 65 years of age were interviewed. Data was analyzed with the ATLAS.ti 22 software. RESULTS.: Three psychological coping strategies were described: emotional coping, which was found more frequently, includes the support of important people, religious coping, and focusing on positive consequences, which leads to a positive reinterpretation and progressive acceptance of the disease; active coping, characterized by diligent action, following indications, and seeking professional support. Finally, avoidance coping, which focuses on negative elements, postponement of the coping process and cognitive and behavioral distractions, the latter being of utmost relevance to balance the activities in the patients' daily lives. CONCLUSIONS.: Participants used emotional coping strategies more frequently, since they tried to increase positive emotions, accompanied by religious and environmental support. In addition, they also used active coping strategies, since they focused their actions to receive medical attention and treatment, leaving aside other activities; in spite of this, they used strategies to take their focus off the condition and thus detach themselves from their worries.

OBJETIVOS.: Motivación para realizar el estudio: es importante conocer el empleo de estrategias de afrontamiento que utilizan las mujeres que tienen cáncer de mama, con la finalidad de contribuir a su bienestar físico y emocional. Principales hallazgos: las estrategias relacionadas al ámbito emocional son utilizadas con mayor intensidad, asimismo, conllevan a una aceptación progresiva de la enfermedad. La distracción cognitiva y conductual resultan necesarias para equilibrar las actividades cotidianas de las pacientes. Implicancias: el comprender cómo las mujeres afrontan su enfermedad, permite la generación de estrategias desde la atención primaria para la mejora de su bienestar. Comprender el afrontamiento psicológico en pacientes mujeres con cáncer de mama de un hospital de Lima Metropolitana. MATERIALES Y MÉTODOS.: La investigación siguió un enfoque cualitativo con un diseño de análisis temático reflexivo. Se entrevistó a 16 mujeres con cáncer de mama entre los 35 y 65 años. El análisis de datos se realizó con apoyo del software ATLAS.ti 22. RESULTADOS.: Se presentaron tres estrategias de afrontamiento psicológico: afrontamiento emocional, el cual se encontró con mayor intensidad, y comprende el apoyo de personas significativas, el afrontamiento religioso y la concentración en las consecuencias positivas, generando una reinterpretación positiva y la aceptación progresiva de la enfermedad; el afrontamiento resolutivo, caracterizado por la acción diligente, con seguimiento a las indicaciones, y la búsqueda de apoyo profesional. Finalmente, el afrontamiento evasivo, se centró en los elementos negativos, el aplazamiento del afrontamiento y la distracción cognitiva y conductual, siendo este último de suma relevancia para equilibrar las actividades en la vida cotidiana de las pacientes. CONCLUSIONES.: Las mujeres emplearon con mayor frecuencia estrategias del estilo emocional, ya que intentan incrementar las emociones positivas, acompañado del apoyo religioso y del entorno; además, utilizaron estrategias relacionadas al estilo resolutivo, puesto que centraron sus acciones para recibir la atención y tratamiento médico, dejando de lado otras actividades; pese a ello, emplearon estrategias para desenfocarse del padecimiento y así desligarse de sus preocupaciones.

Papel de PCA3 y SelectMDx en la optimización de la vigilancia activa en el cáncer de próstata / Role of PCA3 and SelectMDx in the optimization of active surveillance in prostate cancer

Introducción y objetivos: Un porcentaje no despreciable de pacientes incluidos en programas de vigilancia activa (VA) para el cáncer de próstata (CaP) de bajo y muy bajo riesgo son reclasificados en la biopsia confirmatoria o desarrollan progresión de la enfermedad durante el seguimiento. Nuestro objetivo es evaluar el papel del PCA3 y el SelectMDx, de manera individual y combinada, para predecir la progresión patológica (PP) en un programa habitual de VA.Materiales y métodosEstudio prospectivo y observacional que incluyó 86 pacientes inscritos en un protocolo de VA desde 2009 hasta 2019, con resultados de PCA3 y SelectMDx previos al diagnóstico de CaP o durante su periodo de confirmación. Se realizaron análisis univariantes y multivariantes para la correlación de las puntuaciones de PCA3 y SelectMDx, así como de las variables clinicopatológicas con la supervivencia libre de progresión patológica (SLPP). Se definieron los puntos de corte más fiables para ambos biomarcadores en el contexto de VA.ResultadosSelectMDx mostró diferencias estadísticamente significativas en relación con la SLPP (HR: 1,035; IC95%: 1,012-1,057) (p=0,002) con un índiceC de 0,670 (IC95%: 0,529-0,810) y un AUC de 0,714 (IC95%: 0,603-0,825) a 5años. En nuestra serie, el punto de corte más fiable para el SelectMDx fue 5, con una sensibilidad y una especificidad para la PP del 69,8 y del 67,4%, respectivamente. El punto de corte del test PCA3 fue de 65, con una sensibilidad y una especificidad para la PP del 51,16 y del 74,42%, respectivamente. La combinación de ambos biomarcadores no mejoró la predicción de la PP, con un índiceC de 0,630 (IC95%: 0,455-0,805).ConclusionesEn el contexto del CaP de bajo o muy bajo riesgo, SelectMDx >5 predijo una supervivencia libre de PP de 5años con una capacidad de discriminación moderada, superando al PCA3. La combinación de ambos no mejoró los resultados. (AU)

Introduction and objectives: A not negligible percentage of patients included in active surveillance (AS) for low and very low risk prostate cancer (PCa) are reclassified in the confirmatory biopsy or have disease progression during follow-up. Our aim is to evaluate the role of PCA3 and SelectMDx, in an individual and combined way, in the prediction of pathological progression (PP) in a standard AS program.Materials and methodsProspective and observational study comprised of 86 patients enrolled in an AS program from 2009 to 2019, with results for PCA3 and SelectMDx previous to PCa diagnosis or during their confirmatory period. Univariate and multivariate analysis were performed to correlate PCA3 and SelectMDx scores as well as clinical and pathological variables with PP-free survival (PPFS). The most reliable cut-offs for both biomarkers in the context of AS were defined.ResultsSelectMDx showed statistically significant differences related to PPFS (HR: 1.035; 95%CI: 1.012-1.057) (P=.002) with a C-index of 0.670 (95%CI: 0.529-0.810) and AUC of 0.714 (95%CI: 0.603-0.825) at 5years. In our series, the most reliable cut-off point for SelectMDx was 5, with a sensitivity and specificity for PP of 69.8% and 67.4%, respectively. Same figure for PCA3 was 65, with a sensitivity and specificity for PP of 51.16% and 74.42%, respectively. The combination of both biomarkers did not improve the prediction of PP, C-index 0.630 (95%CI: 0.455-0.805).ConclusionsIn the context of low or very low risk PCa, SelectMDx >5 predicted 5years PP free survival with a moderate discrimination ability outperforming PCA3. The combination of both tests did not improved outcomes. (AU)

Role of PCA3 and SelectMDx in the optimization of active surveillance in prostate cancer.

INTRODUCTION & OBJECTIVES: A not negligible percentage of patients included in active surveillance (AS) for low and very low risk prostate cancer (PCa) are reclassified in the confirmatory biopsy or have disease progression during follow-up. Our aim is to evaluate the role of PCA3 and SelectMDx, in an individual and combined way, in the prediction of pathological progression (PP) in a standard AS program. MATERIALS & METHODS: Prospective and observational study comprised of 86 patients enrolled in an AS program from 2009 to 2019, with results for PCA3 and SelectMDx previous to PCa diagnosis or during their confirmatory period. Univariate and multivariate analysis were performed to correlate PCA3 and SelectMDx scores as well as clinical and pathological variables with PP-free survival (PPFS). The most reliable cut-offs for both biomarkers in the context of AS were defined. RESULTS: SelectMDx showed statistically significant differences related to PPFS (HR 1.035, 95%CI: 1.012-1.057) (p = 0.002) with a C-index of 0.670 (95%CI: 0.529-0.810) and AUC of 0.714 (95%CI: 0.603-0.825) at 5 years. In our series, the most reliable cut-off point for SelectMDx was 5, with a sensitivity and specificity for PP of 69.8% and 67.4%, respectively. Same figure for PCA3 was 65, with a sensitivity and specificity for PP of 51.16% and 74.42%, respectively. The combination of both biomarkers did not improve the prediction of PP, C-index 0.630 (95%CI: 0.455-0.805). CONCLUSIONS: In the context of low or very low risk PCa, SelectMDx > 5 predicted 5 years PP free survival with a moderate discrimination ability outperforming PCA3. The combination of both tests did not improved outcomes.

Aneurysm Treatment in Acute SAH with Hydrophilic-Coated Flow Diverters under Single-Antiplatelet Therapy: A 3-Center Experience.

BACKGROUND AND PURPOSE: In certain clinical circumstances, dual-antiplatelet therapy can be problematic in patients with acute SAH. In some aneurysms, however, flow-diverting stents are the ideal therapeutic option. We report our experience with ruptured intracranial aneurysms treated with flow diverters with hydrophilic coating (p48 MW HPC and p64 MW HPC) under single-antiplatelet therapy. MATERIALS AND METHODS: Patients were treated with either flow-diverter placement alone or a flow diverter and additional coiling. Due to the severity of the hemorrhage, the potential for periprocedural rehemorrhage, and the potential for additional surgical interventions, a single-antiplatelet regimen was used in all patients. RESULTS: Thirteen aneurysms were treated in 10 patients. The median age was 62 years; 5 patients were male. All had acute SAH due to aneurysm rupture. Four blood-blister, 2 dissecting, and 7 berrylike aneurysms were treated. Seven aneurysms were adjunctively coiled. Eight of the 10 patients received a single-antiplatelet protocol of aspirin, 1 patient was treated with prasugrel only, and 1 patient was treated with tirofiban first and then switched to the aspirin single-antiplatelet protocol. One device-related complication occurred, a thrombosis of an overstented branch. All stents, however, remained open at DSA, CTA, or MRA follow-up. CONCLUSIONS: The implantation of flow diverters with reduced thrombogenicity due to hydrophilic surface coating under single-antiplatelet therapy seems to be an option in carefully selected cases of SAH due to aneurysm rupture.

Does Increasing Packing Density Using Larger Caliber Coils Improve Angiographic Results of Embolization of Intracranial Aneurysms at 1 Year: A Randomized Trial.

BACKGROUND AND PURPOSE: The impact of increased aneurysm packing density on angiographic outcomes has not been studied in a randomized trial. We sought to determine the potential for larger caliber coils to achieve higher packing densities and to improve the angiographic results of embolization of intracranial aneurysms at 1 year. MATERIALS AND METHODS: Does Embolization with Larger Coils Lead to Better Treatment of Aneurysms (DELTA) was an investigator-initiated multicenter prospective, parallel, randomized, controlled clinical trial. Patients had 4- to 12-mm unruptured aneurysms. Treatment allocation to either 15- (experimental) or 10-caliber coils (control group) was randomized 1:1 using a Web-based platform. The primary efficacy outcome was a major recurrence or a residual aneurysm at follow-up angiography at 12 ± 2 months adjudicated by an independent core lab blinded to the treatment allocation. Secondary outcomes included indices of treatment success and standard safety outcomes. Recruitment of 564 patients was judged necessary to show a decrease in poor outcomes from 33% to 20% with 15-caliber coils. RESULTS: Funding was interrupted and the trial was stopped after 210 patients were recruited between November 2013 and June 2017. On an intent-to-treat analysis, the primary outcome was reached in 37 patients allocated to 15-caliber coils and 36 patients allocated to 10-caliber coils (OR = 0.931; 95% CI, 0.528-1.644; P = .885). Safety and other clinical outcomes were similar. The 15-caliber coil group had a higher mean packing density (37.0% versus 26.9%, P = .0001). Packing density had no effect on the primary outcome when adjusted for initial angiographic results (OR = 1.001; 95% CI, 0.981-1.022; P = .879). CONCLUSIONS: Coiling of aneurysms randomized to 15-caliber coils achieved higher packing densities compared with 10-caliber coils, but this had no impact on the angiographic outcomes at 1 year, which were primarily driven by aneurysm size and initial angiographic results.

Embolismo cerebral durante vuelo comercial: reporte de caso / Cerebral embolism during commercial flight: case report

RESUMEN Presentamos el caso de un varón de 25 años con antecedentes de consumo de marihuana y tabaco, que durante viaje en vuelo comercial a Cusco presentó disnea, pérdida de conciencia y estado epiléptico. Arribó a esta ciudad presentando hipotensión arterial, murmullo pulmonar abolido, sin recuperación de conciencia. La tomografía de tórax reveló bullas pulmonares y la tomografía mostró neumoencéfalo, diagnosticándose embolia gaseosa cerebral. La hipoxemia asociada a convulsiones y pérdida de conciencia en una persona joven durante el vuelo no es un evento común. La pérdida de la presión en la cabina durante el ascenso parece ser el evento desencadenante en pacientes con enfermedad pulmonar.

ABSTRACT We present the case of a 25-year old man with a history of marijuana and tobacco consumption who, during a commercial flight to Cusco, presented dyspnea, loss of consciousness, and epileptic condition. He arrived in this city presenting arterial hypotension, abolished pulmonary murmur, with no recovery of consciousness. The thorax tomography revealed lung bullae and the tomography showed pneumocephalus. He was diagnosed with cerebral gas embolism. Hypoxemia associated with seizures and loss of consciousness in a young person during a flight is not a common event. Loss of cabin pressure during climb appears to be the triggering event in patients with lung disease.

[Cerebral embolism during commercial flight: case report]. / Embolismo cerebral durante vuelo comercial: reporte de caso.

We present the case of a 25-year old man with a history of marijuana and tobacco consumption who, during a commercial flight to Cusco, presented dyspnea, loss of consciousness, and epileptic condition. He arrived in this city presenting arterial hypotension, abolished pulmonary murmur, with no recovery of consciousness. The thorax tomography revealed lung bullae and the tomography showed pneumocephalus. He was diagnosed with cerebral gas embolism. Hypoxemia associated with seizures and loss of consciousness in a young person during a flight is not a common event. Loss of cabin pressure during climb appears to be the triggering event in patients with lung disease.

Presentamos el caso de un varón de 25 años con antecedentes de consumo de marihuana y tabaco, que durante viaje en vuelo comercial a Cusco presentó disnea, pérdida de conciencia y estado epiléptico. Arribó a esta ciudad presentando hipotensión arterial, murmullo pulmonar abolido, sin recuperación de conciencia. La tomografía de tórax reveló bullas pulmonares y la tomografía mostró neumoencéfalo, diagnosticándose embolia gaseosa cerebral. La hipoxemia asociada a convulsiones y pérdida de conciencia en una persona joven durante el vuelo no es un evento común. La pérdida de la presión en la cabina durante el ascenso parece ser el evento desencadenante en pacientes con enfermedad pulmonar.

Curative cerebrovascular reconstruction with the Pipeline embolization device: the emergence of definitive endovascular therapy for intracranial aneurysms.

Endovascular, endosaccular, coil embolization has emerged as an established therapy for both ruptured and unruptured cerebral aneurysms. However, many aneurysms are not cured using conventional endovascular techniques. Coil embolization often results in incomplete aneurysm occlusion or recanalization in the ensuing months after treatment. The Pipeline embolization device (PED; Chestnut Medical) represents a new generation endoluminal implant which is designed to treat aneurysms by reconstructing the diseased parent artery. Immediately after implantation, the PED functions to divert flow from the aneurysm, creating an environment conducive to thrombosis. With time, the PED is incorporated into the vessel wall as neointimal-endothelial overgrowth occurs along the construct. Ultimately, this process results in the durable complete exclusion of the aneurysm from the cerebrovasculature and a definitive endoluminal reconstruction of the diseased parent artery.

Planteamiento de subunidades estéticas del abdomen en base al análisis antropométrico del tejido celular subcutáneo / Approach of abdomen aesthetic subunits based on anthropometric analysis of subcutaneous cell tissue

Introducción y Objetivo. Las técnicas de liposucción han sufrido diversas variaciones en el transcurrir del tiempo; sin embargo, observamos que los resultados estéticos en cuanto a naturalidad en el abdomen en ocasiones no son los mejores a pesar del apoyo tecnológico y de las nuevas técnicas quirúrgicas, pues el abdomen, al ser un área con características específicas en sus diferentes áreas, requiere un tratamiento especial por zonas. Nos proponemos demostrar, mediante el estudio de imágenes, el diferente grosor del tejido celular subcutáneo en el abdomen así como proponer, de acuerdo a los hallazgos, subunidades estéticas del mismo como base al planeamiento prequirúrgico de la liposucción abdominal. Material y método. Evaluamos 14 pacientes mediante ecografía abdominal de partes blandas para medir el grosor del tejido celular subcutáneo en 3 puntos de la zona lateral y 3 puntos de la zona medial del abdomen previamente establecidos, a fin de demostrar si existen diferencias estadísticamente significativas entre ellos. Resultados. El análisis estadístico demostró que existen diferencias estadísticamente significativas respecto al grosor del tejido celular subcutáneo entre la zona medial del abdomen (puntos 4, 5 y 6) con respecto a la zona lateral (puntos 1, 2 y 3) encontrando una relación 2:1; así como diferencias de grosor entre los puntos 1 y 2 en comparación con los puntos 4 y 5; de los puntos 1 y 2 con el punto 3; de los puntos 4 y 5 con el punto 6; y del punto 3 con el punto 6. En base a esas diferencias proponemos dividir el abdomen en una zona medial y otra lateral con subunidades estéticas de acuerdo a sus características morfológicas (grosor del tejido celular subcutáneo). También obtuvimos, de acuerdo a la correlación de Pearson, que dicha diferencia entre la zona medial y lateral del abdomen no está en relación al peso ni a la edad del paciente, pues siempre existe diferencia de grosor del tejido adiposo entre la zona lateral y la medial del abdomen. Conclusiones. Existe diferente grosor del tejido celular subcutáneo abdominal en las diferentes zonas señaladas, por lo que decidimos usar este parámetro para agrupar subunidades estéticas en el abdomen. Inferimos que esto podría ayudar a un planteamiento prequirúrgico para la liposucción abdominal, a fin de conseguir resultados estéticos favorables y conservar los relieves naturales del abdomen

Background and Objective. Liposuction techniques have undergone several variations in the passage of time; however we note that the aesthetic results in terms of naturalness in the abdomen sometimes are not the best despite technological support and new surgical techniques, because the abdomen, being an area that presents specific characteristics in its different areas, requires special treatment by zones. Our aim is to demonstrate by imaging the different thickness of the subcutaneous cellular tissue in the abdomen, as well as to propose new aesthetic subunits of the abdomen according to the findings, as it bases on the preoperative planning of abdominal liposuction. Methods.A series of 14 patients were evaluated using soft tissue abdominal ultrasonography to measure the thickness of the subcutaneous cellular tissue in 3 points of the lateral area and 3 points of the medial zone previously established, in order to demonstrate if there are statistically significant differences between them. Results. Statistical analysis showed that there are statistically significant differences regarding the thickness of the subcutaneous tissue between the medial abdomen (points 4,5 y 6) compared to lateral area (points 1,2 y 3) with a ratio of 2:1, as well as between the points 1 and 2 compared to points 4 and 5; 1 and 2 compared to point 3; 4 and 5 compared to point 6; and point 3 compared to point 6. For these differences it is proposed to divide the abdomen into medial and lateral areas with their aesthetic subunits according to their morphological characteristics (thickness of the subcutaneous cellular tissue). Thus, according to Pearson's correlation, this difference between the medial and lateral areas of the abdomen is not correlated with the patient's weight or age, since there is always a difference in the thickness of adipose tissue between the lateral and medial areas of the abdomen. Conclusions. There is a different thickness of subcutaneous abdominal cell tissue in the different areas indicated, so we decided to group it into aesthetic subunits according to the different morphological characteristic studied (thickness). We infer that this could help a pre-surgical planning for abdominal liposuction and achieve favorable aesthetic results while retaining the natural relief of the abdomen

Lack of Association between Statin Use and Angiographic and Clinical Outcomes after Pipeline Embolization for Intracranial Aneurysms.

BACKGROUND AND PURPOSE: Use of statin medications has been demonstrated to improve clinical and angiographic outcomes in patients receiving endovascular stent placement for coronary, peripheral, carotid, and intracranial stenoses. We studied the impact of statin use on long-term angiographic and clinical outcomes after flow-diverter treatment of intracranial aneurysms. MATERIALS AND METHODS: We performed a post hoc analysis from pooled patient-level datasets from 3 Pipeline Embolization Device studies: the International Retrospective Study of the Pipeline Embolization Device, the Pipeline for Uncoilable or Failed Aneurysms Study, and the Aneurysm Study of Pipeline in an Observational Registry. We analyzed data comparing 2 subgroups: 1) patients on statin medication, and 2) patients not on statin medication at the time of the procedure and follow-up. Angiographic and clinical outcomes were compared by using the χ2 test, Fisher exact test, or Wilcoxon rank sum test. RESULTS: We studied 1092 patients with 1221 aneurysms. At baseline, 226 patients were on statin medications and 866 patients were not on statin medications. The mean length of clinical and angiographic follow-up was 22.1 ± 15.1 months and 28.3 ± 23.7 months, respectively. There were no differences observed in angiographic outcomes at any time point between groups. Rates of complete occlusion were 82.8% (24/29) versus 86.4% (70/81) at 1-year (P = .759) and 93.3% (14/15) versus 95.7% (45/47) at 5-year (P = 1.000) follow-up for statin-versus-nonstatin-use groups, respectively. There were no differences in any complication rates between groups, including major morbidity and neurologic mortality (7.5% versus 7.1%, P = .77). CONCLUSIONS: Our study found no association between statin use and angiographic or clinical outcomes among patients treated with the Pipeline Embolization Device.

Hydrogel versus Bare Platinum Coils in Patients with Large or Recurrent Aneurysms Prone to Recurrence after Endovascular Treatment: A Randomized Controlled Trial.

BACKGROUND AND PURPOSE: Some patients are at high risk of aneurysm recurrence after endovascular treatment: patients with large aneurysms (Patients Prone to Recurrence After Endovascular Treatment PRET-1) or with aneurysms that have previously recurred after coiling (PRET-2). We aimed to establish whether the use of hydrogel coils improved efficacy outcomes compared with bare platinum coils. MATERIALS AND METHODS: PRET was an investigator-led, pragmatic, multicenter, parallel, randomized (1:1) trial. Randomized allocation was performed separately for patients in PRET-1 and PRET-2, by using a Web-based platform ensuring concealed allocation. The primary outcome was a composite of a residual/recurrent aneurysm, adjudicated by a blinded core laboratory, or retreatment, intracranial bleeding, or mass effect during the 18-month follow-up. Secondary outcomes included adverse events, mortality, and morbidity (mRS > 2). The hypothesis was that hydrogel would decrease the primary outcome from 50% to 30% at 18 months, necessitating 125 patients per group (500 for PRET-1 and PRET-2). RESULTS: The trial was stopped once 250 patients in PRET-1 and 197 in PRET-2 had been recruited because of slow accrual. A poor primary outcome occurred in 44.4% (95% CI, 35.5%-53.2%) of those in PRET-1 allocated to platinum compared with 52.5% (95% CI, 43.4%-61.6%) of patients allocated to hydrogel (OR, 1.387; 95% CI, 0.838-2.295; P = .20) and in 49.0% (95% CI, 38.8%-59.1%) in PRET-2 allocated to platinum compared with 42.1% (95% CI, 32.0%-52.2%) allocated to hydrogel (OR, 0.959; 95% CI, 0.428-1.342; P = .34). Adverse events and morbidity were similar. There were 3.6% deaths (1.4% platinum, 5.9% hydrogel; P = .011). CONCLUSIONS: Coiling of large and recurrent aneurysms is safe but often poorly effective according to angiographic results. Hydrogel coiling was not shown to be better than platinum.

Risk Factors for Ischemic Complications following Pipeline Embolization Device Treatment of Intracranial Aneurysms: Results from the IntrePED Study.

BACKGROUND AND PURPOSE: Risk factors for acute ischemic stroke following flow-diverter treatment of intracranial aneurysms are poorly understood. Using the International Retrospective Study of Pipeline Embolization Device (IntrePED) registry, we studied demographic, aneurysm, and procedural characteristics associated with postoperative acute ischemic stroke following Pipeline Embolization Device (PED) treatment. MATERIALS AND METHODS: We identified patients in the IntrePED registry with post-PED-treatment acute ischemic stroke. The rate of postoperative acute ischemic stroke was determined by demographics, comorbidities, aneurysm characteristics, and procedure characteristics (including anticoagulation use, platelet testing, number of devices used, sheaths, and so forth). Categoric variables were compared with χ(2) testing, and continuous variables were compared with the Student t test. Odds ratios and 95% confidence intervals were obtained by using univariate logistic regression. Multivariate logistic regression analysis was used to determine which factors were independently associated with postoperative stroke. RESULTS: Of 793 patients with 906 aneurysms, 36 (4.5%) patients had acute ischemic stroke. Twenty-six (72.2%) strokes occurred within 30 days of treatment (median, 3.5 days; range, 0-397 days). Ten patients died, and the remaining 26 had major neurologic morbidity. Variables associated with higher odds of acute ischemic stroke on univariate analysis included male sex, hypertension, treatment of MCA aneurysms, treatment of fusiform aneurysms, treatment of giant aneurysms, and use of multiple PEDs. However, on multivariate analysis, the only one of these variables independently associated with stroke was treatment of fusiform aneurysms (OR, 2.74; 95% CI, 1.11-6.75; P = .03). Fusiform aneurysms that were associated with stroke were significantly larger than those not associated with stroke (mean, 24.5 ± 12.5 mm versus 13.6 ± 6.8 mm; P < .001). CONCLUSIONS: Ischemic stroke following PED treatment is an uncommon-but-devastating complication. Fusiform aneurysms were the only variable independently associated with postoperative stroke.

International retrospective study of the pipeline embolization device: a multicenter aneurysm treatment study.

BACKGROUND AND PURPOSE: Flow diverters are increasingly used in the endovascular treatment of intracranial aneurysms. Our aim was to determine neurologic complication rates following Pipeline Embolization Device placement for intracranial aneurysm treatment in a real-world setting. MATERIALS AND METHODS: We retrospectively evaluated all patients with intracranial aneurysms treated with the Pipeline Embolization Device between July 2008 and February 2013 in 17 centers worldwide. We defined 4 subgroups: internal carotid artery aneurysms of ≥10 mm, ICA aneurysms of <10 mm, other anterior circulation aneurysms, and posterior circulation aneurysms. Neurologic complications included spontaneous rupture, intracranial hemorrhage, ischemic stroke, permanent cranial neuropathy, and mortality. Comparisons were made with t tests or ANOVAs for continuous variables and the Pearson χ(2) or Fisher exact test for categoric variables. RESULTS: In total, 793 patients with 906 aneurysms were included. The neurologic morbidity and mortality rate was 8.4% (67/793), highest in the posterior circulation group (16.4%, 9/55) and lowest in the ICA <10-mm group (4.8%, 14/294) (P = .01). The spontaneous rupture rate was 0.6% (5/793). The intracranial hemorrhage rate was 2.4% (19/793). Ischemic stroke rates were 4.7% (37/793), highest in patients with posterior circulation aneurysms (7.3%, 4/55) and lowest in the ICA <10-mm group (2.7%, 8/294) (P = .16). Neurologic mortality was 3.8% (30/793), highest in the posterior circulation group (10.9%, 6/55) and lowest in the anterior circulation ICA <10-mm group (1.4%, 4/294) (P < .01). CONCLUSIONS: Aneurysm treatment with the Pipeline Embolization Device is associated with the lowest complication rates when used to treat small ICA aneurysms. Procedure-related morbidity and mortality are higher in the treatment of posterior circulation and giant aneurysms.

Patients prone to recurrence after endovascular treatment: periprocedural results of the PRET randomized trial on large and recurrent aneurysms.

BACKGROUND AND PURPOSE: Some patients with large or recurrent aneurysms may be at increased risk of recurrence postcoiling. The Patients Prone to Recurrence after Endovascular Treatment (PRET) trial was designed to assess whether hydrogel coils were superior to platinum coils in these high-risk patients. This article reports periprocedural safety and operator-assessed angiographic results from the PRET trial. MATERIALS AND METHODS: PRET was a pragmatic, multicenter, randomized controlled trial. Patients had ≥10-mm aneurysms (PRET-1) or a major recurrence after coiling of an aneurysm of any size (PRET-2). Patients were randomly allocated to hydrogel or control arms (any platinum coil) by using concealed allocation with minimization. Assist devices could be used as clinically required. Aneurysms could be unruptured or recently ruptured. Analyses were on an intent-to-treat basis. RESULTS: Four hundred forty-seven patients were recruited (250 PRET-1; 197 PRET-2). Aneurysms were recently ruptured in 29% of PRET-1 and 4% of PRET-2 patients. Aneurysms were ≥10 mm in all PRET-1 and in 50% of PRET-2 patients. They were wide-neck (≥4 mm) in 70% and in the posterior circulation in 24% of patients. Stents were used in 28% of patients (35% in PRET-2). Coiling was successful in 98%. Adverse events occurred in 28 patients with hydrogel and 23 with platinum coils. Mortality (n=2, unrelated to treatment) and morbidity (defined as mRS>2 at 1 month) occurred in 25 patients (5.6%; 12 hydrogel, 13 platinum), related to treatment in 10 (4 hydrogel; 6 platinum) (or 2.3% of 444 treated patients). No difference was seen between hydrogel and platinum for any of the indices used to assess safety up to at least 30 days after treatment. At 1 month, 95% of patients were home with a good outcome (mRS≤2 or unchanged). Operator-assessed angiographic outcomes were satisfactory (complete occlusion or residual neck) in 339 of 447 or 76.4% of patients, with no significant difference between groups. CONCLUSIONS: Endovascular treatment of large and recurrent aneurysms can be performed safely with platinum or hydrogel coils.

Flow diversion versus traditional endovascular coiling therapy: design of the prospective LARGE aneurysm randomized trial.

BACKGROUND AND PURPOSE: The goal of aneurysm treatment is occlusion of an aneurysm without morbidity or mortality. Using well-established, traditional endovascular techniques, this is generally achievable with a high level of safety and efficacy. These techniques involve either constructive treatment of the aneurysm (coils with or without an intravascular stent) or deconstruction (coil occlusion) of the aneurysm and the parent artery. While established as safe and efficacious, the constructive treatment of large and giant aneurysms with coils has typically been associated with relatively lower rates of complete occlusion and higher rates of recurrence. Parent artery deconstruction, though immediately efficacious in achieving complete and durable occlusion, does require occlusion of a major intracranial blood vessel and is associated with risk of stroke. MATERIALS AND METHODS: Flow diversion represents a new technology that can be used to constructively treat large and giant aneurysms. Once excluded successfully, the vessel reconstruction and aneurysm occlusion appears durable. The ability to definitively reconstruct cerebral blood vessels is an attractive approach to these large and giant complex aneurysms and allows the treatment of some aneurysms which were previously not amenable to other therapies. By comparison, conventional coiling techniques have traditionally been used for endovascular treatment of large aneurysms. Large and giant aneurysms that are amenable to either flow diversion or traditional endovascular treatment will be randomized to either therapy with FDA (or appropriate regulatory body) approved devices. RESULTS: The trial is currently enrolling and results of the data are pending the completion of enrollment and follow-up. CONCLUSIONS: This paper details the trial design of the LARGE trial, a blinded, prospective randomized trial of large anterior circulation aneurysms amenable to either traditional endovascular treatments using coils or reconstruction with flow diverters.