Pre-operative Radiotherapy And Deep Inferior Epigastric Artery Perforator (DIEP) flAp study (PRADA): Aesthetic outcome and patient satisfaction at one year.

INTRODUCTION: The optimal combination of radiotherapy and breast reconstruction has not yet been defined. Post-mastectomy radiotherapy (PMRT) has deleterious effects on breast reconstruction, leading to caution amongst surgeons. Pre-operative radiotherapy (PRT) is a growing area of interest, is demonstrated to be safe, and spares autologous flaps from radiotherapy. This study evaluates the aesthetic outcome of PRT and deep inferior epigastric artery perforator (DIEP) flap reconstruction within the Pre-operative Radiotherapy And Deep Inferior Epigastric artery Perforator (DIEP) flAp (PRADA) cohort. METHODS: PRADA was an observational cohort study designed to evaluate the feasibility and safety of PRT for women undergoing neoadjuvant chemotherapy and DIEP reconstruction. Panel evaluation of 3D surface images (3D-SIs) and patient-reported outcome measures (BREAST-Q) for a subset of women in the study were compared with those of a DIEP-PMRT cohort who had undergone DIEP reconstruction and PMRT. RESULTS: Seventeen out of 33 women from the PRADA study participated in this planned substudy. Twenty-eight women formed the DIEP-PMRT cohort (median follow-up 23 months). The median (inter-quartile range [IQR]) 'satisfaction with breasts' score at 12 months for the PRADA cohort was significantly better than the DIEP-PMRT cohort (77 [72-87] versus 64 [54-71], respectively), p=0.01). Median [IQR] panel evaluation (5-point scale) was also significantly better for the PRADA cohort than for the DIEP-PMRT cohort (4.3 [3.9-4.6] versus 3.6 [2.8-4] p=0.003). CONCLUSIONS: Aesthetic outcome for the PRADA cohort was reported to be 'good' or 'excellent' in 93% of cases using a bespoke panel assessment with robust methodology. Patient satisfaction at one year is encouraging and superior to DIEP-PMRT at 23 months. Switching surgery-radiotherapy sequencing leads to similar breast aesthetic outcomes and warrants further large-scale, multi-centre evaluation in a randomised trial

A922 Sequential measurement of 1 hour creatinine clearance (1-CRCL) in critically ill patients at risk of acute kidney injury (AKI)

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Pre-operative Radiotherapy And Deep Inferior Epigastric Artery Perforator (DIEP) flAp study (PRADA): Aesthetic outcome and patient satisfaction at one year.

INTRODUCTION: The optimal combination of radiotherapy and breast reconstruction has not yet been defined. Post-mastectomy radiotherapy (PMRT) has deleterious effects on breast reconstruction, leading to caution amongst surgeons. Pre-operative radiotherapy (PRT) is a growing area of interest, is demonstrated to be safe, and spares autologous flaps from radiotherapy. This study evaluates the aesthetic outcome of PRT and deep inferior epigastric artery perforator (DIEP) flap reconstruction within the Pre-operative Radiotherapy And Deep Inferior Epigastric artery Perforator (DIEP) flAp (PRADA) cohort. METHODS: PRADA was an observational cohort study designed to evaluate the feasibility and safety of PRT for women undergoing neoadjuvant chemotherapy and DIEP reconstruction. Panel evaluation of 3D surface images (3D-SIs) and patient-reported outcome measures (BREAST-Q) for a subset of women in the study were compared with those of a DIEP-PMRT cohort who had undergone DIEP reconstruction and PMRT. RESULTS: Seventeen out of 33 women from the PRADA study participated in this planned substudy. Twenty-eight women formed the DIEP-PMRT cohort (median follow-up 23 months). The median (inter-quartile range [IQR]) 'satisfaction with breasts' score at 12 months for the PRADA cohort was significantly better than the DIEP-PMRT cohort (77 [72-87] versus 64 [54-71], respectively), p=0.01). Median [IQR] panel evaluation (5-point scale) was also significantly better for the PRADA cohort than for the DIEP-PMRT cohort (4.3 [3.9-4.6] versus 3.6 [2.8-4] p=0.003). CONCLUSIONS: Aesthetic outcome for the PRADA cohort was reported to be 'good' or 'excellent' in 93% of cases using a bespoke panel assessment with robust methodology. Patient satisfaction at one year is encouraging and superior to DIEP-PMRT at 23 months. Switching surgery-radiotherapy sequencing leads to similar breast aesthetic outcomes and warrants further large-scale, multi-centre evaluation in a randomised trial

The Characterization of Atrial Fibrillation and Prognostic Value of a Modified 4S-AF Scheme: A Report from the REGUEIFA Community Health Area Registry (Galician Intercentric Registry of Atrial Fibrillation)

Background: The REGUEIFA registry aims to assess the contemporary treatment of patients with atrial fibrillation (AF) in the community health area of Galicia. Due to the prognostic relevance of anticoagulation status, we used it to differentiate patients by adding a category to the stroke domain of the 4S-AF score. Methods: A Cox proportional hazards analysis was used to identify the prognostic value of the modified 4S-AF score regarding mortality, cardiovascular mortality, and thromboembolic events. For bleeding events, we used a Poisson regression model to account for recurrent events. Results: When considering the stroke risk domain as a categorical variable, the risk stratification for all-cause mortality improved by more than 2 times (stroke risk: 2 vs. 1; hazard ratio (HR): 2.17; 95% confidence interval (CI): 1.03–4.55), p = 0.04). According to the Poisson regression model, the stroke risk domain was also an independent factor for hemorrhagic events (HR: 2.83; 95% CI 1.69–4.74, p < 0.001). For patients with permanent AF, the mortality rate was more than 2 times higher than that of patients with paroxysmal AF or their first episode of AF (HR: 2.53; 95% CI; 1.53–4.18); p < 0.001. Anticoagulation therapy was the only independent domain treatment associated with a reduction in all-cause mortality (HR: 0.41; 95% CI 0.19–0.89 p < 0.0023). Conclusions: The modification of the stroke risk score to reflect anticoagulation status may improve the characterization and stratification of overall mortality risk, as demonstrated in the contemporary AF cohort from the REGUEIFA study. The permanent form of AF was associated with a higher risk of overall mortality and cardiovascular mortality

Adjuvant ovarian suppression in premenopausal breast cancer.

BACKGROUND Suppression of ovarian estrogen production reduces the recurrence of hormone-receptor-positive early breast cancer in premenopausal women, but its value when added to tamoxifen is uncertain. METHODS We randomly assigned 3066 premenopausal women, stratified according to prior receipt or nonreceipt of chemotherapy, to receive 5 years of tamoxifen, tamoxifen plus ovarian suppression, or exemestane plus ovarian suppression. The primary analysis tested the hypothesis that tamoxifen plus ovarian suppression would improve disease-free survival, as compared with tamoxifen alone. In the primary analysis, 46.7% of the patients had not received chemotherapy previously, and 53.3% had received chemotherapy and remained premenopausal. RESULTS After a median follow-up of 67 months, the estimated disease-free survival rate at 5 years was 86.6% in the tamoxifen-ovarian suppression group and 84.7% in the tamoxifen group (hazard ratio for disease recurrence, second invasive cancer, or death, 0.83; 95% confidence interval [CI], 0.66 to 1.04; P=0.10). Multivariable allowance for prognostic factors suggested a greater treatment effect with tamoxifen plus ovarian suppression than with tamoxifen alone (hazard ratio, 0.78; 95% CI, 0.62 to 0.98). Most recurrences occurred in patients who had received prior chemotherapy, among whom the rate of freedom from breast cancer at 5 years was 82.5% in the tamoxifen-ovarian suppression group and 78.0% in the tamoxifen group (hazard ratio for recurrence, 0.78; 95% CI, 0.60 to 1.02). At 5 years, the rate of freedom from breast cancer was 85.7% in the exemestane-ovarian suppression group (hazard ratio for recurrence vs. tamoxifen, 0.65; 95% CI, 0.49 to 0.87). CONCLUSIONS Adding ovarian suppression to tamoxifen did not provide a significant benefit in the overall study population. However, for women who were at sufficient risk for recurrence to warrant adjuvant chemotherapy and who remained premenopausal, the addition of ovarian suppression improved disease outcomes. Further improvement was seen with the use of exemestane plus ovarian suppression. (Funded by Pfizer and others; SOFT ClinicalTrials.gov number, NCT00066690.)

Triplet Therapy, Transplantation, and Maintenance until Progression in Myeloma

BACKGROUND In patients with newly diagnosed multiple myeloma, the effect of adding autologous stem-cell transplantation (ASCT) to triplet therapy (lenalidomide, bortezomib, and dexamethasone [RVD]), followed by lenalidomide maintenance therapy until disease progression, is unknown. METHODS In this phase 3 trial, adults (18 to 65 years of age) with symptomatic myeloma received one cycle of RVD. We randomly assigned these patients, in a 1:1 ratio, to receive two additional RVD cycles plus stem-cell mobilization, followed by either five additional RVD cycles (the RVD-alone group) or high-dose melphalan plus ASCT followed by two additional RVD cycles (the transplantation group). Both groups received lenalidomide until disease progression, unacceptable side effects, or both. The primary end point was progression-free survival. RESULTS Among 357 patients in the RVD-alone group and 365 in the transplantation group, at a median follow-up of 76.0 months, 328 events of disease progression or death occurred; the risk was 53% higher in the RVD-alone group than in the transplantation group (hazard ratio, 1.53; 95% confidence interval [CI], 1.23 to 1.91; P<0.001); median progression-free survival was 46.2 months and 67.5 months. The percentage of patients with a partial response or better was 95.0% in the RVD-alone group and 97.5% in the transplantation group (P=0.55); 42.0% and 46.8%, respectively, had a complete response or better (P=0.99). Treatment-related adverse events of grade 3 or higher occurred in 78.2% and 94.2%, respectively; 5-year survival was 79.2% and 80.7% (hazard ratio for death, 1.10; 95% CI, 0.73 to 1.65). CONCLUSIONS Among adults with multiple myeloma, RVD plus ASCT was associated with longer progression-free survival than RVD alone. No overall survival benefit was observed.6 month embargo; published online: 05 June 2022This item from the UA Faculty Publications collection is made available by the University of Arizona with support from the University of Arizona Libraries. If you have questions, please contact us at [email protected]

Predictors for anastomotic leak, postoperative complications, and mortality after right colectomy for cancer: Results from an international snapshot audit

Background: A right hemicolectomy is among the most commonly performed operations for colon cancer, but modern high-quality, multination data addressing the morbidity and mortality rates are lacking. Objective: This study reports the morbidity and mortality rates for right-sided colon cancer and identifies predictors for unfavorable short-term outcome after right hemicolectomy. Design: This was a snapshot observational prospective study. Setting: The study was conducted as a multicenter international study. Patients: The 2015 European Society of Coloproctology snapshot study was a prospective multicenter international series that included all patients undergoing elective or emergency right hemicolectomy or ileocecal resection over a 2-month period in early 2015. This is a subanalysis of the colon cancer cohort of patients. Main Outcome Measures: Predictors for anastomotic leak and 30-day postoperative morbidity and mortality were assessed using multivariable mixed-effect logistic regression models after variables selection with the Lasso method. Results: Of the 2515 included patients, an anastomosis was performed in 97.2% (n = 2444), handsewn in 38.5% (n = 940) and stapled in 61.5% (n = 1504) cases. The overall anastomotic leak rate was 7.4% (180/2444), 30-day morbidity was 38.0% (n = 956), and mortality was 2.6% (n = 66). Patients with anastomotic leak had a significantly increased mortality rate (10.6% vs 1.6% no-leak patients; p 65 0.001). At multivariable analysis the following variables were associated with anastomotic leak: longer duration of surgery (OR = 1.007 per min; p = 0.0037), open approach (OR = 1.9; p = 0.0037), and stapled anastomosis (OR = 1.5; p = 0.041). Limitations: This is an observational study, and therefore selection bias could be present. For this reason, a multivariable logistic regression model was performed, trying to correct possible confounding factors. Conclusions: Anastomotic leak after oncologic right hemicolectomy is a frequent complication, and it is associated with increased mortality. The key contributing surgical factors for anastomotic leak were anastomotic technique, surgical approach, and duration of surgery