Impact of gender on in-hospital and long-term outcomes after transcatheter aortic valve implantation: an analysis of the Spanish TAVI registry.

INTRODUCTION AND OBJECTIVES: Impact of gender on long-term outcomes after transcatheter aortic valve implantation (TAVI) remains uncertain. We aimed to investigate gender-specific differences in TAVI and its impact on outcomes. METHODS: This analysis used data from the prospective Spanish TAVI registry, which included consecutive TAVI patients treated in 46 Spanish centers from 2009 to 2021. The primary endpoint was all-cause mortality at 12 months. Secondary endpoints included in-hospital and 30-day mortality and TAVI-related complications. Adjusted logistic and Cox regression analyses were performed. RESULTS: The study included 12 253 consecutive TAVI patients with a mean age of 81.2 ± 6.4 years. Women (53.9%) were older, and had a higher STS-PROM score (7.0 ± 7.0 vs 6.2 ± 6.7; P < .001) than men. Overall, the TAVI-related complication rate was similar between women and men, with specific gender-related complications. While women more frequently developed in-hospital vascular complications (13.6% vs 9.8%; P < .001) and cardiac tamponade (1.5% vs 0.6%; P = .009), men showed a higher incidence of permanent pacemaker implantation (14.5% vs 17.4%; P = .009). There was no difference in all-cause mortality either in hospital (3.6% vs 3.6%, adjusted odds ratio [OR], 1.01; 95% confidence interval [95%CI], 0.83-1.23; P = .902), at 30 days (4.2% vs 4.2%, adjusted OR, 0.90; 95%CI, 0.65-1.25; P = .564) or at 1 year (11% vs 13%, adjusted HR, 0.94; [0.80-1.11]; P = .60). CONCLUSIONS: women treated with TAVI are older and have more comorbidities than men, leading to distinct complications between genders. Nevertheless, all-cause mortality in the short-term and at 1-year was similar between men and women.

Primer consenso español sobre el uso de la radioterapia intraoperatoria en el cáncer de mama. Conclusiones del panel de expertos / First Spanish consensus on the use of intraoperative radiotherapy in breast cancer. Conclusions of the expert panel

Introducción: la publicación de ensayos aleatorizados con resultados a largo plazo ha demostrado que la radioterapia intraoperatoria (RIO) en cáncer de mama en estadio precoz puede ser una alternativa terapéutica en casos bien seleccionados. En el presente trabajo se presentan los resultados del Primer Consenso de Radioterapia Intraoperatoria en Cáncer de Mama realizado de manera multidisciplinar en España. Material y método: se hizo una revisión sistemática de la literatura y se invitó a todos los oncólogos radioterápicos y cirujanos expertos en RIO en cáncer de mama de España a participar en el consenso. Se aplico la siguiente metodología en 2 fases: a) la creación de un grupo de trabajo y la revisión de la evidencia; b) la realización de la encuesta y generación de recomendaciones consensuadas. Resultados: han participado un total 95,65% de los centros que actualmente utilizan esta técnica en cáncer de mama y que fueron invitados. Los expertos estuvieron de acuerdo en el uso de RIO exclusiva en cáncer de mama en aquellas pacientes mayores de 60 años y por encima de 50 años posmenopáusicas, con carcinoma ductal infiltrante o subtipos histológicos favorables, sin invasión linfovascular, tumores menores o iguales a 25 mm, márgenes de resección libres y receptores hormonales positivos. La utilización de RIO como rescate de recidiva local después de la irradiación externa alcanzó un nivel de consenso muy fuerte. Conclusión: el presente consenso pretende establecer las guías respecto a las indicaciones de RIO exclusiva o como sobreimpresión anticipada y ser una ayuda para la toma conjunta de decisiones. (AU)

Introduction: The publication of randomized trials with long-term results has demonstrated that intraoperative radiation therapy (IORT) in early-stage breast cancer can be a therapeutic alternative for well-selected cases. This paper present work presents the results of the first multidisciplinary consensus on IORT in breast cancer carried out in Spain. Materials and methods: A systematic literature review was conducted, and all radiation oncologists and surgeons with expertise in IORT for breast cancer in Spain were invited to participate in the consensus. The following methodology was employed in two phases: a) creation of a working group and review of the evidence; b) conduct of the survey and generation of consensus recommendations. Results: A total of 95.65% of the invited centers currently utilizing this technique in breast cancer participated. The experts agreed on the use of exclusive intraoperative radiation therapy in breast cancer for patients above 60 years of age and above 50 years postmenopausal, with invasive ductal carcinoma or favorable histological subtypes, no lymphovascular invasion, tumors less than or equal to 25 mm, clear surgical margins, and positive hormone receptor. The use of IORT as salvage surgery for local recurrence after external irradiation achieved a very strong consensus level. Conclusion: The present consensus aims to establish guidelines regarding the indications for exclusive IORT or as an early boost, and to serve as an aid for joint decision-making. (AU)

The value of sentinel lymph-node biopsy in women with node-positive breast cancer at diagnosis and node-negative tumour after neoadjuvant therapy: a systematic review

Purpose To conduct a systematic review to analyse the performance of the sentinel lymph-node biopsy (SLNB) in women with node-positive breast cancer at diagnosis and node-negative tumour after neoadjuvant therapy, compared to axillary lymph-node dissection. Methods The more relevant databases were searched. Main outcomes were false-negative rate (FNR), sentinel lymph-node identification rate (SLNIR), negative predictive value (NPV), and accuracy. We conducted meta-analyses when appropriate. Results Twenty studies were included. The pooled FNR was 0.14 (95% CI 0.11–0.17), the pooled SLNIR was 0.89 (95% CI 0.86–0.92), NPV was 0.83 (95% CI 0.79–0.87), and summary accuracy was 0.92 (95% CI 0.90–0.94). SLNB performed better when more than one node was removed and double mapping was used. Conclusions SLNB can be performed in women with a node-negative tumour after neoadjuvant therapy. It has a better performance when used with previous marking of the affected node and with double tracer (AU)

The value of sentinel lymph-node biopsy in women with node-positive breast cancer at diagnosis and node-negative tumour after neoadjuvant therapy: a systematic review.

PURPOSE: To conduct a systematic review to analyse the performance of the sentinel lymph-node biopsy (SLNB) in women with node-positive breast cancer at diagnosis and node-negative tumour after neoadjuvant therapy, compared to axillary lymph-node dissection. METHODS: The more relevant databases were searched. Main outcomes were false-negative rate (FNR), sentinel lymph-node identification rate (SLNIR), negative predictive value (NPV), and accuracy. We conducted meta-analyses when appropriate. RESULTS: Twenty studies were included. The pooled FNR was 0.14 (95% CI 0.11-0.17), the pooled SLNIR was 0.89 (95% CI 0.86-0.92), NPV was 0.83 (95% CI 0.79-0.87), and summary accuracy was 0.92 (95% CI 0.90-0.94). SLNB performed better when more than one node was removed and double mapping was used. CONCLUSIONS: SLNB can be performed in women with a node-negative tumour after neoadjuvant therapy. It has a better performance when used with previous marking of the affected node and with double tracer.

Consenso de la Sociedad Española de Senología y Patología Mamaria (SESPM) sobre la biopsia selectiva del ganglio centinela (BSGC) y el manejo axilar en el cáncer de mama (2022) / Consensus of the Spanish Society of Breast Senology and Pathology (SESPM) on Selective Biopsy of the Sentinel Node (BSGC) and axylar management in breast cancer (2022)

La estadificación ganglionar inicial está indicada en aquellos casos de carcinoma de mama en los que la información obtenida pueda cambiar la actitud terapéutica o establecer una información pronóstica con implicaciones para el seguimiento de las pacientes.En los últimos años, los cambios conceptuales introducidos por ensayos clínicos y estudios observacionales han generado nuevos retos con disparidad de criterios respecto a la actitud terapéutica a seguir en determinados casos.Ello justifica la necesidad de revisar el último documento del Consenso de la SESPM del año 2013.Aunque el objetivo fundamental del documento es la actualización de la práctica clínica en ganglio centinela de cáncer de mama, los cambios acontecidos en los últimos años en el diagnóstico y el tratamiento de este tumor obligan a incluir aspectos que, aunque ajenos al ámbito estricto del procedimiento de la biopsia selectiva del ganglio centinela, se interrelacionan directamente con él. (AU)

Initial nodal staging is indicated in those cases of breast carcinoma in which the information obtained can change the therapeutic approach or establish prognostic information with implications for patient follow-up.In recent years, the conceptual changes introduced by clinical trials and observational studies have generated new challenges with disparity of criteria regarding the therapeutic approach to be followed in certain cases.This justifies the need to revise the latest consensus document of 2013.Although the main objective of the document is to update clinical practice in sentinel lymph node breast cancer, the changes that have occurred in recent years in the diagnosis and treatment of this tumor make it necessary to include aspects that, although outside the strict scope of the selective sentinel lymph node biopsy procedure, are directly related to it. (AU)

The value of sentinel lymph-node biopsy after neoadjuvant therapy: an overview

PurposeWe conducted a systematic review to analyse the performance of the sentinel lymph-node biopsy (SLNB) after the neoadjuvant chemotherapy, compared to axillary lymph-node dissection, in terms of false-negative rate (FNR) and sentinel lymph-node identification rate (SLNIR), sensitivity, negative predictive value (NPV), need for axillary lymph-node dissection (ALND), morbidity, preferences, and costs.MethodsMEDLINE, Embase, Scopus, and The Cochrane Library were searched. We assessed the quality of the included systematic reviews using AMSTAR2 tool, and estimated the degree of overlapping of the individual studies on the included reviews.ResultsSix systematic reviews with variable quality were selected. We observed a very high overlapping degree across the included reviews. The FNR and the SLNIR were quite consistent (FNR 13–14%; SLNIR ~ 90% or higher). In women with initially clinically node-negative breast cancer, the FNR was better (6%), with similar SLNIR (96%). The included reviews did not consider the other prespecified outcomes.ConclusionsIt would be reasonable to suggest performing an SLNB in patients treated with NACT, adjusting the procedure to the previous marking of the affected lymph node, using double tracer, and biopsy of at least three sentinel lymph nodes. More well-designed research is needed. (AU)

The value of sentinel lymph-node biopsy after neoadjuvant therapy: an overview.

PURPOSE: We conducted a systematic review to analyse the performance of the sentinel lymph-node biopsy (SLNB) after the neoadjuvant chemotherapy, compared to axillary lymph-node dissection, in terms of false-negative rate (FNR) and sentinel lymph-node identification rate (SLNIR), sensitivity, negative predictive value (NPV), need for axillary lymph-node dissection (ALND), morbidity, preferences, and costs. METHODS: MEDLINE, Embase, Scopus, and The Cochrane Library were searched. We assessed the quality of the included systematic reviews using AMSTAR2 tool, and estimated the degree of overlapping of the individual studies on the included reviews. RESULTS: Six systematic reviews with variable quality were selected. We observed a very high overlapping degree across the included reviews. The FNR and the SLNIR were quite consistent (FNR 13-14%; SLNIR ~ 90% or higher). In women with initially clinically node-negative breast cancer, the FNR was better (6%), with similar SLNIR (96%). The included reviews did not consider the other prespecified outcomes. CONCLUSIONS: It would be reasonable to suggest performing an SLNB in patients treated with NACT, adjusting the procedure to the previous marking of the affected lymph node, using double tracer, and biopsy of at least three sentinel lymph nodes. More well-designed research is needed. PROSPERO registration number: CRD42020114403.

Uso de marcador ferromagnético para la detección intraoperatoria de metástasis ganglionar interpectoral de cáncer colorrectal / Use of a Ferromagnetic Marker for the Intraoperative Detection of Interpectoral Lymph Node Metastasis of Colorectal Cancer

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Extending multipoint pacing CRT battery longevity by swapping left ventricular pulse configurations.

PURPOSE: Cardiac resynchronization therapy (CRT) with left ventricular (LV) MultiPoint™ pacing (MPP) has been shown to improve CRT response by pacing two LV sites (LV1, LV2). While an additional LV pacing site reduces battery longevity, this cost can be minimized by leveraging an existing device-based capture management algorithm (LVCap™ Confirm). The purpose of this study was to evaluate the MPP battery longevity improvement achieved by configuring LV pacing sites to properly leverage LVCap Confirm. METHODS: Patients previously enrolled in the MORE-CRT MPP trial with existing MPP-enabled CRT-D devices (Abbott Quadra Assura MP™ CD3371-40QC, Quartet™ LV lead) underwent device interrogation. Device electrical characteristics and estimated battery longevities were compared for various MPP settings. RESULTS: At 2.1 ± 1.1 years post-implant, the estimated remaining battery longevity in 65 patients was 70 ± 14 months with MPP Off (LV pacing from minimum capture threshold). Enabling MPP with maximal anatomical separation between LV1 and LV2 cathodes reduced longevity by 15 ± 14%. However, swapping the LV1 and LV2 cathodes, such that the LV1 threshold was the higher of the two, allowed the device to take full advantage of the LVCap™ Confirm capture management algorithm, resulting in significantly lower longevity reduction of 9 ± 11% (p < 0.001). Ultimately, a mean MPP battery longevity improvement of 7.7 ± 10.3% (p < 0.001) was achieved by simply swapping LV1/LV2 configurations. CONCLUSIONS: By properly leveraging device-based capture management features, the impact of MPP on battery longevity can be significantly reduced.

Linfoma anaplásico de células grandes asociado a implantes mamarios. Documento de consenso (I): epidemiología, patogenia, clínica y diagnóstico / Breast-implant associated anaplastic large-cell lymphoma. Consensus document (I). Epidemiology, pathogenesis, symptoms and diagnosis

El linfoma anaplásico de células grandes asociado a implantes mamarios (BIA-ALCL según sus siglas en inglés) es un tipo raro de linfoma no Hodgkin que se ha descrito en el contexto de la cirugía reconstructiva y estética de mama mediante implantes. Estos artículos presentan un consenso de la Sociedad Española de Senología y Patología Mamaria (SESPM) con la idea de unificar, en esta primera parte, los criterios de diagnóstico de esta enfermedad describiendo asimismo la epidemiología y la etiopatogenia

Breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) is a rare type of non-Hodgkin lymphoma that has been described in the context of reconstructive and aesthetic breast implant surgery. These articles present a consensus of the Spanish Society of Senology and Breast Disease (SESPM). In this first part, the aim is to unify the diagnostic criteria of this disease and describe its epidemiology and etiopathogenesis

Linfoma anaplásico de células grandes asociado a implantes mamarios. Documento de consenso parte II: estadificación, tratamiento, pronóstico y seguimiento / Breast implant-associated anaplastic large-cell lymphoma. Consensus document part II: Staging, prognosis and follow-up

El linfoma anaplásico de células grandes asociado a implantes mamarios (BIA-ALCL según sus siglas en inglés) es un tipo raro de linfoma no Hodgkin que se ha descrito en el contexto de la cirugía reconstructiva y estética de mama mediante implantes. Este segundo artículo presenta la parte del consenso de la Sociedad Española de Senología y Patología Mamaria (SESPM) sobre el tratamiento quirúrgico, médico, radioterápico, pronóstico y seguimiento

Breast implant-associated anaplastic large-cell lymphoma (BIA-ALCL) is a rare type of non-Hodgkin lymphoma that has been described in the context of breast implant reconstructive and cosmetic surgery. This second article presents the consensus of the Spanish Society of Senology and Breast Disease (SESPM) on the medical and surgical treatment of this disease, radiotherapy, prognosis and follow-up

Detección del ganglio centinela mediante trazador paramagnético en el cáncer de tiroides. Estudio piloto técnico / Detection of the sentinel node using a magnetic tracer in thyroid cancer. A technical pilot study

Introducción: La detección del ganglio centinela (GC) no se ha generalizado en la enfermedad tiroidea. Sin embargo, la recientemente detección del GC mediante trazador paramagnético está siendo útil en la cirugía del cáncer de mama y melanoma. El objetivo es evaluar la utilidad del trazador superparamagnetic iron oxide para la detección intraoperatoria del GC en el cáncer papilar de tiroides sin afectación ganglionar en el estudio preoperatorio. Método: Estudio piloto unicéntrico y prospectivo con un producto sanitario de clase IIa (trazador paramagnético). Se incluyen cánceres de tiroides que tras el análisis cito-histológico son tumores T1-T2 con resultado negativo en la evaluación ganglionar preoperatoria, intervenidos de forma programada y consecutiva. Para la localización del GC se realiza una inyección intralesional de 2 ml de superparamagnetic iron oxide. A los 10 minutos se procede a detectar actividad ferromagnética en los ganglios adyacentes. Una vez detectado el ganglio se procede a su extracción y análisis intraoperatorio. Se evalúa la efectividad del procedimiento con la detección de GC, siendo la variable principal la detección o no de mismo. Resultados: Se evalúa el proyecto realizados los 5 primeros casos. Se localiza el CG en todos ellos, en los 4 primeros fácilmente, pero en el quinto fue dificultosa por su localización paratraqueal, que dio interferencias con el tubo endotraqueal con electrodos de neuroestimulación recurrencial. La histología intraoperatoria informó de GC positivo en el 80% (n = 4) de los casos (20% [n = 1] macrometástasis y 60% [n = 3] micrometástasis). Se realizó una tiroidectomía total y el GC condicionó la realización de vaciamientos centrales (n = 4) y un vaciamiento lateral. La histología informa de carcinoma papilar, tipo clásico en el 80% (n = 4) y en el 20% (n = 1) variante folicular. El 40% (n = 2) eran multifocales, el 40% (n = 2) presentaban afectación vascular y el 60% (n = 3) extensión extratiroidea. La estadificación condicionó la aplicación de yodoterapia (150 mCi) en el 80% de los casos (n = 4). Conclusiones: El tratador paramagnético puede ser útil para detectar el GC y estadificar correctamente el carcinoma papilar

Introduction: There is no standard procedure for the detection of the sentinel node (SN) in thyroid disease. However, the recent detection of the SN using a paramagnetic tracer is proving to be useful in breast cancer and melanoma. The objective was to assess the utility of super paramagnetic iron oxide tracer for the intraoperative detection of the SN in patients with papillary thyroid cancer without nodal involvement in the preoperative study. Method: A single center, prospective pilot study of a class IIa medical device (a paramagnetic tracer). The study included thyroid cancers which were T1-T2 tumors in the cytohistological analysis with a negative preoperative nodal assessment, operated on consecutively during scheduled treatment. For the localization of the SN, an interlesional injection of 2 mL of super paramagnetic iron oxide was administered. After ten minutes, ferromagnetic activity was detected in the adjacent nodes. Once the node had been detected, we proceeded by extracting it for intraoperative analysis. The effectiveness of the procedure for detecting the SN was assessed, with the main variable being whether it was detected or not. Results: The project was assessed after the first cases had been carried out. The SN was located in all cases, which was done easily in the first four, but in the fifth case the SN detection was complicated by the interference of the reusable neurostimulation electrodes with the ferromagnetic signal. Intraoperative histology revealed the SN was positive in 80% (n = 4) of cases (20% [n = 1] were macrometastases and 60% [n = 3] micrometastases). Total thyroidectomies were carried out, with central lymph node dissection in 4 of the patients and lateral in one due to the result of the detected SN. The histology showed the ca rcinoma was papillary, a classic type, in 80% (n = 4) and a follicular variant in 20% (n =1). Forty percent (n = 2) were multifocal, 40% (n = 2) had vascular infiltration, and 60% (n = 3) had extrathyroidal extension. Staging determined the application of radioactive iodine therapy (150 mCi) in 80% of cases (n = 4). Conclusions: A paramagnetic tracer can be useful for detecting the SN and correctly staging papillary carcinoma

Detection of the sentinel node using a magnetic tracer in thyroid cancer. A technical pilot study. / Detección del ganglio centinela mediante trazador paramagnético en el cáncer de tiroides. Estudio piloto técnico.

INTRODUCTION: There is no standard procedure for the detection of the sentinel node (SN) in thyroid disease. However, the recent detection of the SN using a paramagnetic tracer is proving to be useful in breast cancer and melanoma. The objective was to assess the utility of super paramagnetic iron oxide tracer for the intraoperative detection of the SN in patients with papillary thyroid cancer without nodal involvement in the preoperative study. METHOD: A single center, prospective pilot study of a class IIa medical device (a paramagnetic tracer). The study included thyroid cancers which were T1-T2 tumors in the cytohistological analysis with a negative preoperative nodal assessment, operated on consecutively during scheduled treatment. For the localization of the SN, an interlesional injection of 2mL of super paramagnetic iron oxide was administered. After ten minutes, ferromagnetic activity was detected in the adjacent nodes. Once the node had been detected, we proceeded by extracting it for intraoperative analysis. The effectiveness of the procedure for detecting the SN was assessed, with the main variable being whether it was detected or not. RESULTS: The project was assessed after the first cases had been carried out. The SN was located in all cases, which was done easily in the first four, but in the fifth case the SN detection was complicated by the interference of the reusable neurostimulation electrodes with the ferromagnetic signal. Intraoperative histology revealed the SN was positive in 80% (n=4) of cases (20% [n=1] were macrometastases and 60% [n=3] micrometastases). Total thyroidectomies were carried out, with central lymph node dissection in 4 of the patients and lateral in one due to the result of the detected SN. The histology showed the carcinoma was papillary, a classic type, in 80% (n=4) and a follicular variant in 20% (n=1). Forty percent (n=2) were multifocal, 40% (n=2) had vascular infiltration, and 60% (n=3) had extrathyroidal extension. Staging determined the application of radioactive iodine therapy (150mCi) in 80% of cases (n=4). CONCLUSIONS: A paramagnetic tracer can be useful for detecting the SN and correctly staging papillary carcinoma.

Cryopreserved amniotic membrane in the treatment of diabetic foot ulcers: a case series.

OBJECTIVE: The amniotic membrane (AM) is a tissue with low immunogenity and high therapeutic potential due to its anti-inflammatory, anti-fibrotic and antimicrobial effects. This paper describes the use of cryopreserved amniotic membrane allografts to treat diabetic foot ulcers (DFUs) in patients with diabetes. METHOD: In this case series, AM was processed to obtain a final medicinal product: cryopreserved amniotic membrane. cryopreserved AM was applied every 7-10 days until total epithelialisation of the DFUs. RESULTS: A total of 14 patients with DFUs (median size: 12.30cm, (range: 0.52-42.5cm2) were treated and followed up until complete closure (median time: 20 weeks, range: 7-56 weeks). Patients received 4-40 AM applications. All patients in this study achieved complete epithelialisation of the wound. No adverse events were observed. CONCLUSION: AM is a feasible and safe treatment in complex DFUs. Furthermore, the treatment is successful in achieving epithelialisation of long-evolution, unhealed wounds resistant to conventional therapies.

Consideraciones terapéuticas de la metástasis en el ganglio centinela de la región poplítea por melanoma / Management of sentinel node melanoma metastasis in the popliteal fossa

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Mirabegron, a Clinically Approved ß3 Adrenergic Receptor Agonist, Does Not Reduce Infarct Size in a Swine Model of Reperfused Myocardial Infarction.

The administration of the selective ß3 adrenergic receptor (ß3AR) agonist BRL-37344 protects from myocardial ischemia/reperfusion injury (IRI), although the lack of clinical approval limits its translatability. We tested the cardioprotective effect of mirabegron, the first-in-class ß3AR agonist approved for human use. A dose-response study was conducted in 6 pigs to select the highest intravenous dose of mirabegron without significant detrimental hemodynamic effect. Subsequently, closed chest anterior myocardial infarction (45 min ischemia followed by reperfusion) was performed in 26 pigs which randomly received either mirabegron (10 µg/kg) or placebo 5 min before reperfusion. Day-7 cardiac magnetic resonance (CMR) showed no differences in infarct size (35.0 ± 2.0% of left ventricle (LV) vs. 35.9 ± 2.4% in mirabegron and placebo respectively, p = 0.782) or LV ejection fraction (36.3 ± 1.1 vs. 34.6 ± 1.9%, p = 0.430). Consistent results were obtained on day-45 CMR. In conclusion, the intravenous administration of the clinically available selective ß3AR agonist mirabegron does not reduce infarct size in a swine model of IRI.