Patient Characteristics and Outcomes Associated with Sentinel Protection Device Use in Patients with Aortic Valve Disease Undergoing TAVR in a "Real-World" Setting.

Background: Transcatheter aortic valve replacement (TAVR) has become the dominant treatment for aortic valve disease. While TAVR safety has improved over time, concern remains over the occurrence of cerebrovascular accidents (CVA) secondary to device placement, which is associated with increased morbidity and mortality. The Sentinel Cerebral Protection System (CPS) was developed to reduce the risk of embolic strokes associated with debris produced during TAVR. Studies evaluating Sentinel CPS efficacy have produced conflicting results, and there is little understanding of which patients are selected for device placement in "real-world" settings. With no existing guidelines on device use, the purpose of this study was to describe and compare the characteristics of patients who receive CPS with those who do not in a "real-world" setting of consecutive TAVR patients and evaluate its impact on postoperative complications, namely stroke. Methods: This was a single-center, retrospective study of all patients undergoing TAVR between July 1, 2019, and December 31, 2020. Patient demographics, baseline, and perioperative characteristics were collected prospectively using the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry and our institution's TAVR database for analysis. Postoperative outcomes were assessed using primary endpoints of in-hospital/30-day stroke and the composite of death, stroke, and bleeding/vascular events at one-year. To adjust for baseline differences, a propensity score was developed including all factors that were different between groups, and Multivariate Cox Regression analysis was used to control for these differences. Patient follow-up was 97% complete at 12 months with 100% echocardiographic follow-up. Results: A total of 242 consecutive patients (57.9% male) were analyzed, with a mean age of 79.9 ± 9 years. Of these patients, 134 (55.4%) received the Sentinel CPS and 108 (44.6%) did not. Sentinel CPS patients were more likely to be male, not on dialysis, without prior CVA or pacemaker, had less severe chronic lung disease, and were lower operative risk compared to concurrent non-CPS patients. CPS patients were also found to have higher hemoglobin and albumin levels, lower creatinine, and were less likely to be on immunosuppressant therapy. The incidence of in-hospital/30-day stroke after TAVR did not differ between CPS and non-CPS patients (0.0% vs. 1.9%; p = 0.198). Unadjusted analyses at one-year showed a lower occurrence of the composite endpoint in CPS patients compared non-CPS patients (8.3% vs. 17.0%; p = 0.034). After adjustment, the hazard ratio (Adj HR) for the CPS group was no longer significantly associated with a lower composite endpoint (Adj HR = 0.609, 95% CI 0.244-1.523; p = 0.289). Both unadjusted (p = 0.233) and adjusted (p = 0.132) analyses showed no difference in the incidence of stroke at one-year. Conclusions: Our study demonstrates that in a "real-world" setting, the Sentinel CPS device is more likely to be used in healthier and less complex patients. In analyses adjusted for illness severity and patient complexity, CPS use did not have a significant effect on the incidence of in-hospital/30-day stroke or the composite endpoint of death, stroke, and bleeding/vascular events at one-year.

Implications of Bicuspid Aortic Valve Disease and Aortic Stenosis/Insufficiency as Risk Factors for Thoracic Aortic Aneurysm.

Bicuspid Aortic Valves (BAV) are associated with an increased incidence of thoracic aortic aneurysms (TAA). TAA are a common aortic pathology characterized by enlargement of the aortic root and/or ascending aorta, and may become life threatening when left untreated. Typically occurring as the sole pathology in a patient, TAA are largely asymptomatic. However, in some instances, they are accompanied by aortic valve (AV) diseases: either congenital BAV or acquired in the form of Aortic Insufficiency (AI) or aortic stenosis (AS). When TAA are associated with aortic valve disease, determining an accurate and predictable prognosis becomes especially challenging. Patients with AV disease and concomitant TAA lack a widely accepted diagnostic approach, one that integrates our knowledge on aortic valve pathophysiology and encompasses multi-modality imaging approaches. This review summarizes the most recent scientific knowledge regarding the association between AV diseases (BAV, AI, AS) and ascending aortopathies (dilatation, aneurysm, and dissection). We aimed to pinpoint the gaps in monitoring practices and prediction of disease progression in TAA patients with concomitant AV disease. We propose that a morphological and functional analysis of the AV with multi-modality imaging should be included in aortic surveillance programs. This strategy would allow for improved risk stratification of these patients, and possibly new AV phenotypic-specific guidelines with more vigilant surveillance and earlier prophylactic surgery to improve patient outcomes.

Full endoscopic minimally invasive extraperitoneal modified Sugarbaker approach for para-colostomy hernia repair: Technical aspects and 2-year follow-up results of a prospective cohort.

AIM: This study aimed to assess technical aspects and clinical results of a new minimally invasive technique in parastomal hernia (PSH) repair, full endoscopic retromuscular access, after 2 years of follow-up. METHODS: Data from consecutive patients requiring minimally invasive ventral PSH repair were collected from 2019 to 2022. The inclusion criteria were patients aged between 18 and 80 years old with symptomatic PSH. Demographics and perioperative and postoperative data were collected. Postoperative pain and functional recovery were compared with preoperative data. RESULTS: Twelve patients with symptomatic PSH were included. The mean PSH defect area was 16.2 cm2 and the mean midline defect was 8.7 cm2 . No intra-operative complications or conversion to open surgery were detected. One patient (8%) required postoperative readmission due to partial bowel obstruction symptoms that required catheterization of the stoma. Pain significantly worsened after the first postoperative day compared to preoperative data but improved after the first postoperative month compared to the first postoperative week and after the 90th postoperative day compared to the first postoperative month, with significant differences. Significant restriction improvement was identified when 30 days after surgery data were compared to preoperative data and when the 180th postoperative day results were compared to 30 days after surgery. The average follow-up was 29 months. During the follow-up no clinical or radiological recurrence was observed. CONCLUSION: This paper shows low rate of intra- and postoperative complications with significant improvement in terms of pain activities restriction compared to preoperatory. After 29 months follow-up, no recurrence was identified, confirming that this approach offers good mid-term results.

Advances in immunotherapy in cervical cancer.

Cervical cancer represents a major public health problem, being the fourth most common cancer in incidence and mortality in women worldwide. Patients with recurrent, persistent, or metastatic disease unsuitable for curative therapeutic approaches have a dismal prognosis. Until recently, these patients were only candidates for cisplatin-based chemotherapy plus bevacizumab. However, the introduction of immune checkpoint inhibitors has revolutionized the treatment of this disease, achieving historical overall survival improvements in both the post-platinum and front-line settings. Interestingly, the clinical development of immunotherapy in cervical cancer is currently advancing to the locally advanced setting, although preliminary efficacy outcomes in this setting have been disappointing so far. Moreover, promising data are emerging from early-phase trials on novel immunotherapy approaches, such as human papillomavirus therapeutic vaccines and adoptive cell therapy. This review summarizes the main clinical trials carried out in the field of immunotherapy in the last several years.

Persistent lymph nodes after curative chemoradiotherapy for head and neck cancer: imaging predictors of response for decision-making.

PURPOSE: To identify response predictors in patients with head and neck squamous cell carcinoma (N + HNSCC) and persistent lymph nodes after curative chemoradiotherapy treatment (CCRT). MATERIALS AND METHODS: Consecutive patients with N + HNSCC treated with CCRT and persistent lymph nodes at first follow-up between 2015 and 2021 were identified and analyzed. Complete response was defined as the absence of lymph node metastatic involvement in patients with salvage lymphadenectomy or the absence of progression after 1 year of successive follow-ups. Tumour type and location, staging, and human papillomavirus (HPV) status were considered for analysis. The number and size of lymph nodes, type, shape, enhancement and margins on diagnostic and follow-up CT were also analyzed. RESULTS: The cohort included 46 patients with 134 pathological lymph nodes. Logistic regression models showed the following variables to be significant: performance of salvage lymphadenectomy (OR 0.094, [CI 95% 0.004-0.61], p = 0.037); the type of lymphadenopathy on diagnostic CE-CT (solid vs. cystic) (N1: OR = 4.11, [CI 95% 1.11-17.93], p = 0.042 and N3: OR 6.42, [CI 95% 1.2-42.56], p = 0.036); the change of shape (round to oval) on the follow-up CE-CT (OR 9.76, [CI 95% 1.79-8.57], p = 0.016) and the time in days between CCRT and the first follow-up CE-CT (OR 1.06, [CI 95% 1.004-1.13], p = 0.048). CONCLUSIONS: In our experience, the presence of solid lymph nodes on pre-treatment CT and the change in shape from round to oval on post-treatment CT are predictors of response to treatment in patients with N + HNSCC persistent lymph nodes after CCRT. Increasing the temporal interval between treatment and follow-up CT should be considered to avoid unnecessary nodal dissections.

[Consensus of the ambulatory surgery commite section of the Spanish Association of Surgeons on the role of ambulatory surgery in the SARS-CoV-2 pandemic]. / Consenso de la sección de cirugía mayor ambulatoria de la Asociación Española de Cirujanos sobre el papel de la cirugía mayor ambulatoria en la pandemia SARS-CoV-2.

The current situation of the SARS-CoV-2 pandemic has paralyzed non-urgent and/or oncological surgery in many hospitals in our country with what it means for the health of citizens who are awaiting a surgical procedure. Outpatient Surgery can afford more than 85% of the surgical procedures that are performed in a surgical department and is presented as a feasible and safe alternative at the present time since it does not require admission and decreases clearly the risk of infection. In addition, it is the tool that should be generalized to solve the accumulation of patients on the waiting list that the pandemic is generating, so it seems appropriate that the Ambulatory Surgery section of the Spanish Association of Surgeons present a series of recommendations for the implementation of outpatient surgery in these exceptional circumstances that we have to live.

Emerging systemic antitarget treatment for differentiated thyroid carcinoma.

PURPOSE OF REVIEW: We review the new systemic treatment strategies for differentiated thyroid carcinoma, as well as the acquaintance of its molecular biology. RECENT FINDINGS: Multiple kinase inhibitor drugs have become the standard therapy for thyroid cancer, albeit several adverse effects. In the last few years, new molecules have raised with an overall safety profile. Most of them, are considered targeted therapies directed toward driven-molecules alterations, such as neurotrophic tyrosine kinase receptor (NTRK) inhibitors for NTRK-fusion thyroid cancer and rearranged during transfection (RET) inhibitors for RET-fusion thyroid cancer. Recently, promising outcomes and safety data have been presented. Furthermore, other novel strategies for advanced thyroid carcinoma are currently investigated in clinical trials.The ability to provide precision medicine to patients in routine clinical settings depends on the availability of molecular profiling test at their cancer centers. The impossibility to perform molecular characterization could turn out to be a diagnostic and treatment limitation for some patients. SUMMARY: The treatment of advanced differentiated thyroid carcinoma has undergone rapid evolution in the last decade. An emerging treatment era is coming. From now to then, we will need to face the different types of diagnostic tools for molecular characterization, their interpretation and, finally the access to targeted therapies.

Three years prospective clinical and radiologic follow-up of laparoscopic sacrocolpoperineopexy.

BACKGROUND: When Rectocele is part of a complex pelvic organ prolapse, a full repair is recommended. The aim of this study was to evaluate the clinical and radiological results after laparoscopic surgery in patients with symptomatic rectocele and III/IV stage vaginal vault prolapse METHODS: This is a prospective cohort study of women with symptomatic rectoceles and middle compartment prolapse operated on between 2013 and 2015, who underwent a laparoscopic sacrocolpoperineopexy with synthetic Y mesh attached to puborectalis muscles, the anterior and posterior vagina wall and the sacrum. The clinical outcomes measured were symptoms of prolapse, obstructive defecation syndrome and quality of life. Radiological outcomes were distance of the vaginal vault below pubococcigeal line and depth of rectovaginal wall protrusion in dynamic pelvic resonance. RESULTS: 33 patients were included. 32 of them remained asymptomatic after a three years follow-up. Significant differences were shown in the obstructed defecation score and quality of life after 6, 12 and 36 months compared to preoperatively. No differences were identified when the postoperative results were compared. Significant differences were shown in preoperative vaginal vault prolapse (3.2 cms ± 0.8 SD below the pubococcigeal Line) and rectocele size, compared with 1 and 3 years after surgery. There were no significant differences in vaginal vault prolapse when compared after 1 and 3 years. When rectocele size after 1 and 3 years was compared, significant differences were shown, but only one clinical recurrence (3%) was identified after a mean follow-up of 47 months. CONCLUSIONS: Laparoscopic sacrocolpoperineopexy in patients with symptomatic rectocele and III/IV vaginal vault prolapse solves the constipation and obstructed defecation with an excellent quality of life and low clinical recurrences. Radiological deterioration, especially in rectocele size, was identified in the mid-term follow-up without clinical significance.

Circulating and tissue matricellular RNA and protein expression in calcific aortic valve disease.

Aortic valve sclerosis is a highly prevalent, poorly characterized asymptomatic manifestation of calcific aortic valve disease and may represent a therapeutic target for disease mitigation. Human aortic valve cusps and blood were obtained from 333 patients undergoing cardiac surgery (n = 236 for severe aortic stenosis, n = 35 for asymptomatic aortic valve sclerosis, n = 62 for no valvular disease), and a multiplex assay was used to evaluate protein expression across the spectrum of calcific aortic valve disease. A subset of six valvular tissue samples (n = 3 for asymptomatic aortic valve sclerosis, n = 3 for severe aortic stenosis) was used to create RNA sequencing profiles, which were subsequently organized into clinically relevant gene modules. RNA sequencing identified 182 protein-encoding, differentially expressed genes in aortic valve sclerosis vs. aortic stenosis; 85% and 89% of expressed genes overlapped in aortic stenosis and aortic valve sclerosis, respectively, which decreased to 55% and 84% when we targeted highly expressed genes. Bioinformatic analyses identified six differentially expressed genes encoding key extracellular matrix regulators: TBHS2, SPARC, COL1A2, COL1A1, SPP1, and CTGF. Differential expression of key circulating biomarkers of extracellular matrix reorganization was observed in control vs. aortic valve sclerosis (osteopontin), control vs. aortic stenosis (osteoprotegerin), and aortic valve sclerosis vs. aortic stenosis groups (MMP-2), which corresponded to valvular mRNA expression. We demonstrate distinct mRNA and protein expression underlying aortic valve sclerosis and aortic stenosis. We anticipate that extracellular matrix regulators can serve as circulating biomarkers of early calcific aortic valve disease and as novel targets for early disease mitigation, pending prospective clinical investigations.

Arterial Grafts for Coronary Bypass: A Critical Review After the Publication of ART and RADIAL.

Observational and randomized evidence shows that arterial grafts have better patency rates than saphenous vein grafts (SVGs) in coronary artery bypass grafting. Observational studies suggest that the use of multiple arterial grafts is associated with longer postoperative survival, but this must be interpreted in the context of treatment allocation bias and hidden confounders intrinsic to the study designs. Recently, a pooled analysis of 6 randomized trials comparing the radial artery with the SVG as the second conduit and the largest randomized trial comparing the use of single and bilateral internal thoracic arteries have provided apparently divergent results about a clinical benefit with the use of >1 arterial conduit. However, both analyses have methodological limitations that may have influenced their results. At present, it is unclear whether the well-documented increased patency rate of arterial grafts translates into clinical benefits in the majority of patients undergoing coronary artery bypass grafting. A large randomized trial testing the arterial grafts hypothesis (ROMA [Randomized Comparison of the Clinical Outcome of Single Versus Multiple Arterial Grafts]) is underway and will report the results in a few years.