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Objective The study objective was to determine whether mini-invasive transthoracoscopic atrial fibrillation ablation can delay the progression of atrial fibrillation from paroxysmal to persistent. Methods Patients aged 18 to 80 years with paroxysmal nonvalvular atrial fibrillation and a history of stroke or systemic thromboembolism were consecutively enrolled from September 2014 to June 2019. In the treatment group, patients underwent transthoracoscopic atrial fibrillation ablation plus left atrial appendage excision (atrial fibrillation ablation plus left atrial appendage excision group). Patients unwilling to receive surgical intervention were treated with antiarrhythmic drugs and oral anticoagulants and recruited as a control group (atrial fibrillation plus antiarrhythmic drugs group). The primary end point was the progression of atrial fibrillation from paroxysmal to persistent. Results This study included 49 patients in the atrial fibrillation plus antiarrhythmic drugs group (29 men) and 77 patients in the atrial fibrillation ablation plus left atrial appendage excision group (48 men). In the atrial fibrillation ablation plus left atrial appendage excision group, after a median follow-up of 951 days (interquartile range, 529-1366 days), 8 patients (10.4%) progressed to persistent atrial fibrillation. In the atrial fibrillation plus antiarrhythmic drugs group, after a median follow-up of 835 days (interquartile range, 548-1214 days), 14 patients (28.6%) progressed to persistent atrial fibrillation. The atrial fibrillation ablation plus left atrial appendage excision group had a significantly lower incidence of atrial fibrillation progression than the atrial fibrillation plus antiarrhythmic drugs group during follow-up (3.9 vs 12.3 per 100 person-years, log-rank 8.6, P = .003). Conclusions Patients with paroxysmal nonvalvular atrial fibrillation who chose to undergo transthoracoscopic atrial fibrillation ablation had a lower incidence of progression to persistent atrial fibrillation than patients who chose conservative therapy. This strategy might be especially suitable for patients with paroxysmal nonvalvular atrial fibrillation at high risk of stroke and high risk of bleeding.

Introduction The authors tested the hypothesis that the EEG feature generalized polyspike train (GPT) is associated with drug-resistant idiopathic generalized epilepsy (IGE). Methods The authors conducted a single-center case-control study of patients with IGE who had outpatient EEGs performed between 2016 and 2020. The authors classified patients as drug-resistant or drug-responsive based on clinical review and in a masked manner reviewed EEG data for the presence and timing of GPT (a burst of generalized rhythmic spikes lasting less than 1 second) and other EEG features. A relationship between GPT and drug resistance was tested before and after controlling for EEG duration. The EEG duration needed to observe GPT was also calculated. Results One hundred three patients were included (70% drug-responsive and 30% drug-resistant patients). Generalized polyspike train was more prevalent in drug-resistant IGE (odds ratio, 3.8; 95% confidence interval, 1.3-11.4; P = 0.02). This finding persisted when controlling for EEG duration both with stratification and with survival analysis. A median of 6.5 hours (interquartile range, 0.5-12.7 hours) of EEG recording was required to capture the first occurrence of GPT. Conclusions The findings support the hypothesis that GPT is associated with drug-resistant IGE. Prolonged EEG recording is required to identify this feature. Thus, >24-hour EEG recording early in the evaluation of patients with IGE may facilitate prognostication.

Objective Standard surgical repair of acute type A aortic dissection is associated with high mortality rates, especially in high-risk patients. In an attempt to improve survival in frail patients, we evaluated the outcomes after ascending aorta wrapping in a high-risk patient cohort. Methods This single-center retrospective cohort study included all consecutive patients treated using ascending aorta wrapping for an acute type A aortic dissection from 2008 to 2019. The primary end points included 30-day mortality, survival during follow-up, and dissection-related mortality. Secondary end points included assessment of aortic remodeling after ascending aorta wrapping. Patients with an aortic anatomy suitable for adjunctive endografting of the ascending aorta were also identified. Results Thirty-five consecutive patients who underwent ascending aorta wrapping were included. Their median age was 77 years (range, 46-96 years). The 30-day all-cause mortality rate was 9%. Major complications occurred in 7 patients (21%), including early reinterventions in 11 (31%). Median follow-up was 36 months (range, 2.4-106.6; interquartile range, 72). The actuarial survival at 36 months was 82%. The dissection-related mortality was 11.4%. The median aortic growth of the nonwrapped descending thoracic aorta was 3.4 mm. Computed tomography scan analysis depicted that 88% of survivors were theoretical candidates for an additional endovascular procedure to exclude the primary entry tear. Conclusions Aortic wrapping is associated with favorable early outcomes and a low rate of aortic events during follow-up. This therapeutic option should be considered for patients considered too fragile for standard surgical repair.

Objective Transcarotid access for transcatheter aortic valve replacement is emerging as an alternative to more traditional nonfemoral access options such as transapical or transaortic; however, comparative data are limited. The purpose of the study was to analyze outcomes after transcatheter aortic valve replacement using transcatheter compared with transthoracic (transapical/transaortic) access. Methods The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry was queried for patients who underwent transcarotid, transapical, or transaortic transcatheter aortic valve replacement with the SAPIEN 3 (Edwards Lifesciences, Irvine, Calif) transcatheter heart valve between June 2015 and July 2019. Thirty-day unadjusted outcomes were evaluated, and propensity score matching and logistic regression were used to compare transcatheter access with transthoracic access. Results In the propensity-matched analysis, 667 transcarotid transcatheter aortic valve replacement procedures were compared with 1334 transthoracic procedures. Transcarotid transcatheter aortic valve replacement was associated with lower mortality (4.2% vs 7.7%, P = .004), less new-onset atrial fibrillation (2.2% vs 12.1%, P Conclusions Transcatheter aortic valve replacement using transcarotid access is associated with lower 30-day mortality, less atrial fibrillation, shorter intensive care unit and overall length of stay, fewer readmissions, greater improvement in Kansas City Cardiomyopathy Questionnaire scores, and no significant difference in stroke or major vascular complications compared with transthoracic access.

Background & Aims Efforts to assess and improve the effectiveness of Barrett’s esophagus (BE) screening and surveillance are ongoing in the United States. Currently, there are limited population-based data in the United States to guide these efforts. Methods We performed a retrospective cohort study using data from large commercial and Medicare Advantage health plans in the United States from 2004 – 2019. We identified individuals with BE and analyzed the proportion who developed EAC. EACs were classified as prevalent EAC (diagnosed within 30 days of index endoscopy), post-endoscopy esophageal adenocarcinoma (PEEC, diagnosed 30 – 365 days after index endoscopy), and incident EAC (diagnosed 365 days or more after index endoscopy). Using this cohort, we performed a nested case-control study to identify factors associated with prevalent EAC at BE diagnosis and study healthcare utilization prior to BE diagnosis. Results We identified 50,817 individuals with incident BE. Of the 366 who developed EAC, 67.2%, 13.7%, and 19.1% were diagnosed with prevalent EAC, PEEC, and incident EAC respectively. Factors positively associated with prevalent EAC versus BE without prevalent EAC included male sex, dysphagia, weight loss, and Charlson-Deyo comorbidity score. In those with prevalent EAC, most patients with dysphagia or weight loss had their symptoms first recorded within three months of EAC diagnosis. Healthcare utilization rates were similar between those with and without prevalent EAC. Conclusions Two-thirds of EACs among individuals with BE are diagnosed at the time of BE diagnosis. Additionally, PEEC accounts for 14% of these EACs. These results may guide future research studies that investigate novel BE diagnostic strategies that reduce the morbidity and mortality of EAC.

The purpose of the present study was to compare survival outcomes in propensity score-matched patients aged 70 years or greater receiving a bilateral internal thoracic artery graft with patients receiving a single internal thoracic artery graft.Among 4083 consecutive patients with isolated coronary artery bypass grafting who underwent operation between January 2001 and December 2018, we identified 1300 patients aged 70 years or greater; of these, 968 received a bilateral internal thoracic artery (bilateral internal thoracic artery group) and 332 received a single internal thoracic artery (single internal thoracic artery group). Propensity score matching was used to reduce the preoperative patient differences. The 10-year survival and postoperative complications were compared between the 2 groups.A Kaplan-Meier curve at 10 years of follow-up showed that crude survival was significantly superior in patients with bilateral internal thoracic artery grafts than in patients with single internal thoracic artery grafts (67.0% ± 2.5% vs 56.0% ± 3.4%, respectively; P .016). In the actuarial survival, estimates for propensity score-matched patients with a bilateral internal thoracic artery showed a significantly higher rates of survival than patients with a single internal thoracic artery by the end of follow-up (66.0% ± 5.3% vs 53.0% ± 3.9%, respectively; hazard ratio, 0.64; 95% confidence interval, 0.44-0.94; P = .022, univariable Cox Model and multivariable analysis hazard ratio, 0.66; 95% confidence interval, 0.45-0.97; P = .036 Cox model). Postoperative complications were all similar between the single internal thoracic artery and bilateral internal thoracic artery groups.The use of bilateral internal thoracic artery grafting in older patients improves 10-year survival, with similar postoperative morbidity. This surgical technique might have beneficial effects in survival in patients aged more than 70 years. Its use could be considered more frequently.

Background: Acute stroke patients are usually transported to the nearest hospital regardless of their required level of care. This can lead to increased pressure on emergency departments and treatment delay. Objective: The aim of the study was to explore the benefit of a mobile stroke unit (MSU) in the UK National Health Service (NHS) for reduction of hospital admissions. Methods: Prospective cohort audit observation with dispatch of the MSU in the East of England Ambulance Service area in Southend-on-Sea was conducted. Emergency patients categorized as code stroke and headache were included from June 5, 2018, to December 18, 2018. Rate of avoided admission to the accident and emergency (A&E) department, rate of admission directly to target ward, and stroke management metrics were assessed. Results: In 116 MSU-treated patients, the following diagnoses were made: acute stroke, n = 33 (28.4%); transient ischaemic attacks, n = 13 (11.2%); stroke mimics, n = 32 (27.6%); and other conditions, n = 38 (32.8%). Pre-hospital thrombolysis was administered to 8 of 28 (28.6%) ischaemic stroke patients. Pre-hospital diagnosis avoided hospital admission for 29 (25.0%) patients. As hospital treatment was indicated, 35 (30.2%) patients were directly triaged to the stroke unit, 1 patient (0.9%) even directly to the catheter laboratory. Thus, only 50 (43.1%) patients required transfer to the A&E department. Moreover, the MSU enabled thrombolysis with a median dispatch-to-needle time of 42 min (interquartile range, 40–60). Conclusion: This first deployment of an MSU in the UK NHS demonstrated improved triage decision-making for or against hospital admission and admission to the appropriate target ward, thereby reducing pressure on strained A&E departments.

Objective This cohort investigation identified primary predictors of discharge walking function of nonambulatory individuals poststroke with high-intensity training (HIT) during inpatient rehabilitation. Design Observational cohort investigation. Setting Inpatient rehabilitation. Participants Data were collected from individuals (N=257) Intervention Clinical physical therapy interventions attempted to maximize stepping practice at higher intensities. Main Outcome Measures Primary outcomes included the discharge level of assistance required during walking (minimal or no assistance) and attainment of specific gait speed thresholds (0.4 and 0.8 m/s) during the 10-m walk test. Independent predictors were demographics, training interventions (including steps/day), baseline Berg Balance Scale (BBS), and paretic leg strength. Results Participants performed a median (interquartile range) of 1270 (533-2297) steps per day throughout inpatient rehabilitation, with significant differences between those who walked with versus without assistance at discharge. Logistic regressions indicate steps per day was a primary predictor of unassisted walking recovery; removal of steps per day resulted in primary predictors of baseline BBS and strength. Receiver operating characteristic (ROC) analyses indicate significant areas under the curve for BBS and relatively low cutoff scores of 5.5 points at admission to walk without assistance at any speed. ROC analyses performed using 1-week outcomes indicate BBS scores of 5-17 points were needed to achieve locomotor thresholds. Conclusion Stepping activity, BBS, and paretic leg strength were primary predictors of walking outcomes in patients performing HIT, and ROC analyses indicated recovery of independent walking could be achieved in low functioning patients early poststroke.

Because generalized pustular psoriasis (GPP) is rare, there are few studies reporting treatments and outcomes for large numbers of patients.To report treatments and outcomes in a large cohort of patients hospitalized with GPP.Using a Japanese national inpatient database, we identified 1516 patients with GPP who required hospitalization between July 2010 and March 2019. We categorized patients into 3 medication groups: biologics (294 patients), oral agents without biologics (948 patients), and systemic corticosteroids only (274 patients). We investigated their characteristics, treatments, and outcomes.Mean age was 66 years (interquartile range: 52-77 years). Fifty patients (3.3%) were admitted to the intensive care unit, 125 (8.2%) required blood pressure support, and 63 (4.2%) died. Patients who received biologics were younger and had fewer comorbidities. In-hospital mortality was lower in the biologics group (1.0% [biologics group] vs 3.7% [oral-agents group] vs 9.1% [corticosteroids-only group]; P .001) as was morbidity (5.4% vs 8.2% vs 12%, respectively; P = .02). Among those who received biologics, IL-17 inhibitor use increased over time, with in-hospital mortality and morbidity comparable to those of tumor necrosis factor inhibitors.Retrospective study design. Some patients received multiple medications.Biologic treatments showed favorable outcomes compared with other treatments.

Background Patients treated in Australian intensive care units (ICUs) have an overall mortality rate of 5.05%. This is due to the critical nature of their disease, the increasing proportion of patients with multiple comorbidities, and advanced age. This has made treating patients during the end of life an integral part of intensive care practice and requires a high quality of care. With the increased use of electronic clinical information systems, a standardised protocol encompassing end-of-life care may provide an efficient method for documentation, communication, and timely delivery of comfort care. Objective The aim of the study was to determine if an electronic clinical information system–based end-of-life care protocol improved nurses' satisfaction with the practice of end-of-life care for patients in the ICU. Design This is a prospective single-centre observational study. Setting The study was carried out at a 20-bed cardiothoracic and general ICU between 2015 and 2017. Participants The study participants were ICU nurses. Intervention Electronic clinical information–based end-of-life care protocol was used in the study. Outcome The primary outcome was nurse satisfaction obtained by a survey. Results The number of respondents for the before survey and after survey was 58 (29%) and 64 (32%), respectively. There was a significant difference between the before survey and the after survey with regard to feeling comfortable in transitioning from curative treatment (median = 2 [interquartile range {IQR} = 2, 3] vs 3 [IQR = 2, 3], p = 0.03), feeling involved in the decision to move from curative treatment to end-of-life care (median = 2 [IQR = 2, 2] vs 2 [IQR 2, 3], p = 0.049), and feeling religious beliefs/rituals should be respected during the end-of-life process (median = 4 [IQR = 3, 4] vs. 4 [IQR = 4, 4], p = 0.02). There were some practices that had a low satisfaction rate on both the before survey and after survey. However, a high proportion of nurses were satisfied with many of the end-of-life care practices. Conclusion The nurses were highly satisfied with many aspects of end-of-life care practices in this unit. The use of an electronic clinical information system–based protocol improved nurse satisfaction and perception of quality of end-of-life care practices for three survey questions.

Background: Sedation is often required in the intensive care unit (ICU) but can be harmful if administered inappropriately or excessively. Dexmedetomidine offers a favourable, cooperative sedation profile, despite a higher relative cost. It also has analgesic and opioid-sparing properties. The multidisciplinary ICU at our central South African hospital adopted the use of dexmedetomidine through the course of 2016. The aim of the study was to determine whether this change in practice affected the ICU length of stay (LOS) and duration of mechanical ventilation at this unit.Methods: A retrospective cohort analysis of patients’ files, who were sedated with midazolam and propofol in 2015 and those sedated with dexmedetomidine in 2017, was conducted. The data gathered included the sedatives used, demographic and vital data, ICU LOS, duration of mechanical ventilation and treatment of side-effects. Group 2015 and Group 2017 were also analysed for possible confounders where appropriate, and these confounders were excluded for a re-analysis. Descriptive statistics were used and results were analysed for range, median, interquartile range (IQR), percentage and frequency. For post-hoc analysis of the effect of confounders, the Spearman rank correlation coefficient was used to determine the association between duration and sedative exposure and either duration of ICU stay or mechanical ventilation. The null hypothesis was set at p < 0.05.Results: Group 2015 comprised 52 patients and Group 2017 60 patients. No difference between the groups was found regarding ICU LOS (median [IQR] 5 [2–14] vs 8.5 [5–12.5] days; p = 0.10) or mechanical ventilation (median [IQR] 91 [34–272] vs 129 [58–221] hours; p = 0.44). Those who were sedated with dexmedetomidine had better initial prognoses (median APACHE II score 13 vs 18, p = 0.01), were sedated for greater fractions of their total ICU stay (median 46% vs 25%, p < 0.01), and had a higher incidence of hypotension and bradycardia (36.7% vs 11.4%; p < 0.01); which did not relate to a higher mortality. Spearman’s rank correlation coefficients also showed a weak to moderate association with longer ICU stay and ventilation duration when the duration of sedation with midazolam or propofol was shorter in relation to ICU stay.Conclusion: We did not find a reduction in ICU LOS or mechanical ventilation with the advent of dexmedetomidine in our unit. The lack of regular documentation of sedation levels and scheduled sedation breaks might have contributed to these results. Dexmedetomidine has a role to play in the ICU setting, but it should only be used when clearly indicated. Vigilance for hypotension and bradycardia is required when using dexmedetomidine.

BACKGROUND Dupilumab has been demonstrated to be an effective treatment for patients with moderate-to-severe atopic dermatitis (AD) in clinical trials. However, evidence of real-world experience with dupilumab in a broader population is limited to date. METHODS Adult patients with moderate-to-severe AD, defined as an Eczema Area Severity Index (EASI) score of 24 or higher, treated with dupilumab at ten Italian academic centers, were included in the study. Physician-reported outcome measures (EASI), patient-reported outcome measures (pruritus and sleep score, Dermatology Life Quality Index, DLQI) and serological markers [immunoglobulin (Ig) E and eosinophil count] after 16 weeks were analyzed. RESULTS We enrolled 543 patients with moderate-to-severe AD. Two patients (0.4%) discontinued treatment. The median ± interquartile percentage change from baseline to 16 weeks of treatment in the EASI score was -87.5±22.0 (p

Introducción: Un número significativo de pacientes con COVID-19 requieren ingreso en la unidad de cuidados intensivos (UCI). Sin embargo, la mortalidad varía entre los estudios. Objetivos: Determinar las características clínicas y el pronóstico de los adultos con COVID-19 ingresados en UCI en Colombia durante la primera ola de la pandemia. Materiales y métodos: Este estudio retrospectivo multicéntrico se realizó en 8 hospitales. Se incluyeron pacientes con infección confirmada por SARS-CoV-2, de marzo a julio de 2020. Resultados: Durante el período de estudio, 229 adultos con COVID-19 ingresaron en las UCI. La mayoría de los pacientes (54,5%) tenían más de 65 años. Se documentaron comorbilidades en 146 (64%) pacientes, principalmente hipertensión arterial y diabetes mellitus. La mediana de la puntuación SOFA al ingreso en UCI fue de 5 (rango intercuartílico, 2-12). En cuanto a las complicaciones, 118 (51,5%) requirieron ventilación mecánica, 51 (22,4%) terapia de reemplazo renal y 85 (35%) uso de vasopresores. La mortalidad fue 38,4% (88 de 219 pacientes). La mortalidad aumentó con la edad (20% en menores de 40 años y 54,1% en mayores de 65 años; p

BACKGROUND: Disability in patients with medically refractory ulcerative colitis (UC) after total proctocolectomy (TPC) with ileal pouch anal anastomosis (IPAA) is not well understood. The aim of this study was to compare disability in patients with IPAA vs medically managed UC, and identify predictors of disability. METHODS: This was a multi-center cross-sectional study performed at five academic institutions in New York City. Patients with medically or surgically treated UC were recruited. Clinical and socioeconomic data were collected and the inflammatory bowel disease disability index (IBD-DI) was administered to eligible patients. Predictors of moderate-severe disability (IBD-DI≥35) were assessed in univariable and multivariable models. RESULTS: A total of 94 patients with IPAA and 128 patients with medically managed UC completed the IBD-DI. Among patients with IPAA and UC, 35 (37.2%) and 30 (23.4%) had moderate-severe disability, respectively. Patients with IPAA had significantly greater IBD-DI scores compared to patients with medically managed UC (29.8 vs 17.9, p

BACKGROUND The Society of Thoracic Surgeons (STS) Intermacs Registry represents a real-world data source of durable, left ventricular assist devices that can address knowledge gaps not informed through randomized clinical trials. We sought to compare survival with contemporary left ventricular assist device technologies using multiple analytic approaches to assess concordance of treatment effects and to validate prior STS Intermacs observations. METHODS Patients (≥19 years of age) enrolled into STS Intermacs between August 2017 and June 2019 were stratified by device type (continuous flow, centrifugal left ventricular assist device with hybrid levitation [CF-HL] or full magnetic levitation [CF-FML]). The primary outcome was 1-year survival assessed by 3 statistical methodologies (multivariable regression, propensity score matching, and instrumental variable analysis). RESULTS Of 4448 patients, 2012 (45.2%) received the CF-HL and 2436 (54.8%) received the CF-FML. One-year survival for the CF-FML was 88% vs 79% for the CF-HL (overall P < .001), with a hazard ratio for mortality of 3.18 for the CF-HL (P < .0001) after risk adjustment. With propensity score matching (n = 1400 each cohort), 1-year survival was 87% for the CF-FML vs 80% for the CF-HL, with a hazard ratio of 3.20 for mortality with the CF-HL (P < .0001) after risk adjustment. With an instrumental variable analysis, the probability of receiving the CF-HL was associated with a hazard ratio of 3.11 (P < .0001). CONCLUSIONS Statistical methodology using propensity score matching and instrumental variable analysis increased the robustness of observations derived from real-world data and demonstrates the feasibility of performing comparative effectiveness research using STS Intermacs. These analyses provide additional evidence supporting a survival benefit of the CF-FML vs CF-HL.

Background Eosinophils have been implicated in the pathogenesis of ulcerative colitis and have been associated with disease course and therapeutic response. However, associations between eosinophil density, histologic activity, and clinical features have not been rigorously studied. Methods A deep learning algorithm was trained to identify eosinophils in colonic biopsies and validated against pathologists’ interpretations. The algorithm was applied to sigmoid colon biopsies from a cross-sectional cohort of 88 ulcerative colitis patients with histologically active disease as measured by the Geboes score and Robarts histopathology index (RHI). Associations between eosinophil density, histologic activity, and clinical features were determined. Results The eosinophil deep learning algorithm demonstrated almost perfect agreement with manual eosinophil counts determined by 4 pathologists (interclass correlation coefficients: 0.805–0.917). Eosinophil density varied widely across patients (median 113.5 cells per mm2, interquartile range 108.9). There was no association between eosinophil density and RHI (P = 0.5). Significant differences in eosinophil density were seen between patients with Montreal E3 vs E2 disease (146.2 cells per mm2 vs 88.2 cells per mm2, P = 0.005). Patients on corticosteroids had significantly lower eosinophil density (62.9 cells per mm2 vs 124.1 cells per mm2, P = 0.006). No association between eosinophil density and biologic use was observed (P = 0.5). Conclusions We developed a deep learning algorithm to quantify eosinophils in colonic biopsies. Eosinophil density did not correlate with histologic activity but did correlate with disease extent and corticosteroid use. Future studies applying this algorithm in larger cohorts with longitudinal follow-up are needed to further elucidate the role of eosinophils in ulcerative colitis.

Data on factors governing long-term adherence to a gluten-free diet (GFD) in celiac disease (CD) are scarce. We aimed to determine trends and clinical predictors of long-term GFD adherence in adult CD.Initial and long-term (3 years) GFD adherence, clinical characteristics at baseline and follow-up were collected retrospectively from celiac patients followed-up over 20 years (2000-2020). Predictors of long-term GFD adherence at diagnosis, and follow-up were evaluated by multivariate logistic regression.248 patients (37 ± 12 years, 186F, median time on a GFD 90 months) were included. Twenty-five (10.1%) had only short-term follow-up (3 years) while 223 (89.9%) had initial and long-term dietary assessment. 187/223 (83.9%) patients were initially adherent and 36/223 (16.1%) were not. 17/36 (47.2%) patients initially not adherent become adherent, while only 4/187 (2.1%) initially adherent patients became not adherent. In the long-term, 200/223 (89.7%) were adherent and 21/223 (9.4%) patients were not. Adherence improved more frequently than worsened (OR, 39.5; 95% CI, 11.4-178.5; P.01). Classical symptoms (diarrhea, weight loss) at diagnosis of CD predicted stricter long-term GFD adherence (OR, 3.27; 95% CI, 1.21-8.81; P = .02), while anemia (OR, 0.31; 95% CI, 0.12-0.82; P = .02) and dermatitis herpetiformis (OR, 0.23; 95% CI, 0.06-0.91; P = .04) predicted poorer long-term adherence. At follow-up, initial GFD adherence (OR, 42.70; 95% CI, 10.70-171.00; P = .04) was the major determinant of long-term GFD adherence.GFD adherence changes over time in10% of patients, generally improving when it does. Major determinants of long-term GFD adherence are classical symptoms at diagnosis and initial adherence to a GFD. Patients with anemia or dermatitis herpetiformis at diagnosis require stricter dietetic input.

Background: Pathological stage and grade of renal pelvis urothelial carcinoma (RPUC) are difficult to estimate before radical nephroureterectomy (RNU). Objective: To examine tumor size as an independent predictor of muscle-invasive and/or non–organ-confined rates of RPUC at RNU. Design, setting, and participants: Within the Surveillance, Epidemiology and End Results (SEER) database (2004–2016), we identified nonmetastatic RPUC at RNU. Outcome measurements and statistical analysis: First, we examined stage and grade distributions. Second, two separate univariable and subsequent multivariable logistic regression models (LRMs) were fitted to test the association between tumor size and the rate of (1) muscle-invasive or higher (pT2–4N0–2) and (2) non–organ-confined (pT3–4N0–2) RPUC at RNU. Results and limitations: Of 4657 patients, 3052 (65.5%) had pT2–4N0–2 and 2382 (51.2%) pT3–4N0–2 RPUC at RNU. The median tumor size was 3.7 cm (interquartile range 2.5–5.0). The high-grade RPUC rate ranged from 71.1% to 87.2% (p < 0.001) among SEER registries. Conversely, no differences were recorded for stage (p > 0.05) or tumor size (p = 0.1) across all registries. Rates of pT2–4N0–2 and pT3–4N0–2 RPUC increased with tumor size. Specifically, for tumor size intervals from 0.1–1.0 cm to 9.1–10.0 cm, the pT2–4N0–2 rate ranged from 45% to 83% and the pT3–4N0–2 rate ranged from 23% to 75%, respectively (both p < 0.001). In multivariable LRMs, tumor size (in 1-cm units) was an independent predictor of pT2–4N0–2 (odds ratio [OR] 1.25; p < 0.001) and pT3–4N0–2 (OR 1.30; p < 0.001) disease at RNU. Conclusions: Tumor size is a key predictor of muscle-invasive or non–organ-confined RPUC. Greater tumor size directly and virtually linearly predicts a higher rate of invasive or non–organ-confined RPUC at RNU. Patient summary: For patients with cancer in urinary tract cells lining the kidney, larger tumor size predicts worse stage of the disease at surgery.

Background and Aims We conducted a systematic review and meta-analysis to summarize emerging data on the safety and effectiveness of dual biologic therapy in combination or with tofacitinib in patients with refractory inflammatory bowel disease (IBD). Methods Through a systematic search of multiple electronic databases through November 9, 2020, we identified cohort studies or case series (>10 patients) reporting the safety and effectiveness of simultaneous use of biologic agents in combination or with tofacitinib in patients with IBD. Rates of adverse events, clinical remission, and endoscopic remission were synthesized using pooled data, and we identified factors associated with successful dual therapy. Results We identified 30 studies reporting 288 trials of dual biologic or small molecule therapy in 279 patients (76% Crohn’s disease; median duration of treatment 24 weeks (IQR25-IQR75 1332)). The main indications for dual therapy included medically refractory IBD (81%) and concurrent extra-intestinal manifestations or rheumatologic disease (12%). The most common combinations of dual therapy included tumor necrosis factor-α antagonists & anti-integrins (48%), ustekinumab & anti-integrins (19%); 61% of patients had previously failed at least one of the two therapies used in combination. Over a median follow-up of 32 weeks (IQR25-IQR75 24-52), pooled rates of adverse and serious adverse events were 31% (95% CI, 13%-54%) and 6.5% (95% CI, 2.1%-13.1%); pooled rates of clinical and endoscopic remission were 59% (95% CI, 42%-74%), and 34% (95% CI, 23%-46%), respectively. 12% (95% CI, 4%-24%) of patients required surgery. Rates of success were higher in patients on dual therapy due to EIM. Heterogeneity was not significant for endoscopic response (P = .88, I2 = 0%), endoscopic remission (P = .44, I2 = 0%), and malignancy (P = .87, I2 = 0%). However, significant heterogeneity existed for other outcomes. Conclusions Dual biologic or small molecule therapy may be a possible option in highly selected, refractory IBD patients at specialized centers. Higher quality combination of therapies with a significant improvement in the quality of data is required prior to more widespread use.

Background Dabrafenib (D) and trametinib (T) improved survival in patients with BRAFV600mut melanoma. High plasma concentration of D (PCD) is weakly associated with adverse events (AE). We investigated the relationship between PCD/T and tumour control or AE. Methods We analysed PCD/T in patients treated with D + T for metastatic melanoma. We collected data of tumour response (RECIST 1.1) and AE (CTCAE 4.0) blinded to PCD/T results. Results We analysed 71 D and 58T assays from 34 patients. High inter-individual variability of PCD (median: 65.0 ng/mL; interquartile range (IQR) [4–945]) and of PCT (median: 8.6 ng/mL; IQR [5–39]) was observed. We found a weak relationship between PCD and progression-free survival, taking follow-up time into account (hazard ratio 0.991; 95%CI, 0.981 to 1.000; P = 0.06). However, no difference was observed between mean PCD/T of progressing patients (n = 21; 125 ± 183 ng/mL and 9.3 ± 3.6 ng/mL, respectively) and responders (complete, partial or stable response) (n = 13; 159 ± 225 ng/mL, P = 0.58 and 10.6 ± 24.4 ng/mL, P = 0.29, respectively). No significant relationship was found between PCD/T and most common AEs (fever, lymphopenia, CPK increase, and hepatic cytolysis), body mass index, or age. Mean CPT (n = 16) was significantly higher for female subjects (n = 18; 11.5 ± 4.8 ng/mL) than for male subjects (8.8 ng/mL ± 2.9, P = 0.01), but no difference was observed between sex and CPD (P = 0.32). Conclusion Our study showed a weak relationship between PCD and progression-free survival, but no relationship between PCD/T and AE was found. Monitoring PCD and PCT alone is unlikely to be useful in assessing response to treatment.

Background The efficacy and safety of ursodeoxycholic acid (UDCA) for the treatment of liver disease associated with cystic fibrosis (CF) are under discussion, and clinical practice varies among centers. The study aimed at evaluating if the incidence of severe liver disease differs between CF centers routinely prescribing or not prescribing UDCA. Methods We carried out a retrospective multicenter cohort study including 1591 CF patients (1192 patients from UDCA-prescribing centers and 399 from non-prescribing centers) born between 1990 and 2007 and followed from birth up to 31 December 2016. We computed the crude cumulative incidence (CCI) of portal hypertension (PH) at the age of 20 years in the two groups and estimated the subdistribution hazard ratio (HR) through a Fine and Gray model. Results Over the observation period, 114 patients developed PH: 90 (7.6%) patients followed-up in UDCA prescribing centers and 24 (6.0%) in non-prescribing centers. The CCI of PH at 20 years was 10.1% (95% CI: 7.9-12.3) in UDCA-prescribing and 7.7% (95% CI: 4.6-10.7) in non-prescribing centers. The HR among patients followed in prescribing centers indicated no significant difference in the rate of PH either in the unadjusted model (HR: 1.21, 95% CI: 0.69-2.11) or in the model adjusted for pancreatic insufficiency (HR: 1.28, 95% CI: 0.77-2.12). Conclusions CF patients followed-up in UDCA prescribing centers did not show a lower incidence of PH as compared to those followed in centers not prescribing UDCA. These results question the utility of UDCA in reducing the occurrence of severe liver disease in CF.

Background: The Oncotype DX assay is a clinically validated 17-gene genomic assay that provides a genomic prostate score (GPS; scale 0-100) measuring the heterogeneous nature of prostate tumors. The test is performed on prostate tissue collected during biopsy. There is a lack of data on the association between the GPS and tumor pathology after radical prostatectomy (RP). Objective: To investigate the association between GPS and final pathology, including extra prostatic extension (EPE), positive surgical margin (PSM), and seminal vesicle invasion (SVI). Design, setting, and participants: Data for the 749 patients who underwent Oncotype DX assay and RP at a referral prostate cancer center between 2015 and 2019 were retrospectively assessed to evaluate the association between GPS and unfavorable pathology parameters. Intervention: After a GPS genetic test, patients underwent robotic RP performed by the same surgeon. Outcome measurement and statistical analysis: Multivariable logistic regression analyses were performed to assess the association between GPS and EPE, PSM, and SVI. The models were adjusted for age, clinical stage, prostate-specific antigen (PSA) level, Gleason score, and time between the genomic assay and surgery. The median time between Oncotype DX assay and surgery was 176 d (interquartile range [IQR] 141-226). The median age was 63 yr (IQR 58-68), median GPS was 29 (IQR 21-39), and median PSA was 5.7 ng/ml (IQR 4.6-7.7). In multivariable analyses assessing the odds ratio (OR) per 20-point change in GPS, GPS was an independent predictor of EPE (OR 1.8, 95% confidence interval [CI] 1.4-2.3) and SVI (OR 2.1, 95% CI 1.3-3.4). In addition, when patients were grouped by GPS quartile, the percentage of cases with EPE and SVI increased with the GPS quartile. Conclusions: We provide evidence that the Oncotype DX GPS is significantly associated with adverse pathology after RP. Specifically, the risk of EPE and SVI increases with the GPS. Therefore, use of the Oncotype DX GPS may help clinicians to improve preoperative patient counseling and develop surgical strategies for patients with a higher chance of EPE or unfavorable pathological features. Patient summary: We studied whether the score for a prostate genetic test was associated with prostate cancer pathology findings for patients who had their prostate removed. We found that the risk of prostate cancer spread outside the gland and to the seminal vesicle increases with higher test scores. These findings may help surgeons in counseling patients on surgical options for prostate cancer. (C) 2021 European Association of Urology. Published by Elsevier B.V. All rights reserved.

Background It has been shown that metrics recorded for instrument kinematics during robotic surgery can predict urinary continence outcomes. Objective To evaluate the contributions of patient and treatment factors, surgeon efficiency metrics, and surgeon technical skill scores, especially for vesicourethral anastomosis (VUA), to models predicting urinary continence recovery following robot-assisted radical prostatectomy (RARP). Design, setting, and participants Automated performance metrics (APMs; instrument kinematics and system events) and patient data were collected for RARPs performed from July 2016 to December 2017. Robotic Anastomosis Competency Evaluation (RACE) scores during VUA were manually evaluated. Training datasets included: (1) patient factors; (2) summarized APMs (reported over RARP steps); (3) detailed APMs (reported over suturing phases of VUA); and (4) technical skills (RACE). Feature selection was used to compress the dimensionality of the inputs. Outcome measurements and statistical analysis The study outcome was urinary continence recovery, defined as use of 0 or 1 safety pads per day. Two predictive models (Cox proportional hazards [CoxPH] and deep learning survival analysis [DeepSurv]) were used. Results and limitations Of 115 patients undergoing RARP, 89 (77.4%) recovered their urinary continence and the median recovery time was 166 d (interquartile range [IQR] 82–337). VUAs were performed by 23 surgeons. The median RACE score was 28/30 (IQR 27–29). Among the individual datasets, technical skills (RACE) produced the best models (C index: CoxPH 0.695, DeepSurv: 0.708). Among summary APMs, posterior/anterior VUA yielded superior model performance over other RARP steps (C index 0.543–0.592). Among detailed APMs, metrics for needle driving yielded top-performing models (C index 0.614–0.655) over other suturing phases. DeepSurv models consistently outperformed CoxPH; both approaches performed best when provided with all the datasets. Limitations include feature selection, which may have excluded relevant information but prevented overfitting. Conclusions Technical skills and “needle driving” APMs during VUA were most contributory. The best-performing model used synergistic data from all datasets. Patient summary One of the steps in robot-assisted surgical removal of the prostate involves joining the bladder to the urethra. Detailed information on surgeon performance for this step improved the accuracy of predicting recovery of urinary continence among men undergoing this operation for prostate cancer.

Purpose This analysis of the pivotal phase 3 HAWK and HARRIER trials aimed to provide insights on the timing of presentation, management, and outcomes of intraocular inflammation (IOI)-related adverse events (AEs), as reported by investigators in these trials. Design Post hoc analysis of investigator-reported IOI-related AEs in HAWK and HARRIER. Participants Of 1088 brolucizumab-treated eyes (3 or 6 mg), 49 eyes demonstrated at least 1 IOI-related AE and were included in this analysis. Methods Reports of IOI-related AEs were analyzed and descriptive statistics were provided for outcome measures. Main Outcome Measures Incidence and description of eyes with IOI-related AEs, timing of presentation, management, clinical outcomes, and brolucizumab treatment after the first IOI-related AE. Results Seventy IOI-related AEs were reported in 49 eyes. Before the onset of first IOI-related AE, eyes received a mean ± standard deviation (SD) of 3.9 ± 2.2 brolucizumab injections. Median time to first IOI-related AE from the last administered brolucizumab injection was 18.0 days (interquartile range, 4.0–29.0 days). Of the 70 AEs, 61 (87.1%) were treated, most with topical corticosteroids; systemic and intraocular corticosteroids were used for 3 AEs each. Overall, inflammation resolved completely in 39 eyes (79.6%), resolved with sequelae in 5 eyes (10.2%), and did not resolve in 5 eyes (10.2%) by end-of-study (EOS). Overall, the mean ± SD best-corrected visual acuity (BCVA) change from baseline to EOS, before AE to the lowest BCVA in 3 months after AE, and from before AE to EOS were −0.84 ± 20.6 , −16.31 ± 17.6, and −0.22 ± 18.9 Early Treatment Diabetic Retinopathy Study (ETDRS) letters, respectively. Of the 36 eyes (73.5%) that continued with brolucizumab therapy after the first IOI-related AE, 24 completed the trials and 12 discontinued; mean ± SD BCVA change in these eyes was 2.6 ± 17.6, 7.8 ± 13.2, and −7.7 ± 21.3 ETDRS letters, respectively, from baseline to EOS. The remaining 13 eyes (26.5%) were not treated with brolucizumab after first IOI-related AE and showed a mean ± SD BCVA change of −10.4 ± 25.5 ETDRS letters from baseline to EOS. Conclusions Findings of this analysis highlight the need for continued vigilance and monitoring for any signs of IOI-related events in patients receiving brolucizumab.

Background Intradiverticular bladder tumors (IDBT) are rare but clinically important, as they are difficult to assess endoscopically due to limited anatomic access and risk of perforation. MRI may be helpful in assessing IDBT and providing relevant staging and prognostic information. Purpose To assess MRI findings of IDBT and their relationship with overall survival. Methods This retrospective study included 31 consecutive patients with IDBT undergoing MRI from 2008 to 2018 identified through electronic medical records and PACS database search. Two radiologists independently assessed the following MRI features: size (>3 vs ≤3 cm), diverticular neck involvement, Vesical Imaging-Reporting and Data System (VI-RADS) score (>3 vs ≤3), perivesical fat infiltration, additional tumors and suspicious pelvic lymph nodes. Overall survival was estimated using Kaplan-Meier analysis; and the relationship with clinicopathological and MRI features was determined using the Cox proportional-hazards regression model. Inter-reader agreement was assessed using intraclass correlation coefficients (ICC) and Cohen's kappa (K). Results Median follow-up was 1044 days (interquartile range, 474–1952 days). Twenty-six (83.9%) patients underwent surgical treatment with or without neoadjuvant chemotherapy. On MRI, greater tumor size (>3 cm), diverticular neck involvement, perivesical extension, and suspicious lymph nodes were associated with lower overall survival (HR = 3.6–8.1 and 4.3–6.3 for the 2 radiologists, p ≤ 0.03). Other clinicopathological or MRI findings were not associated with survival (p = 0.27–0.65). Inter-reader agreement was excellent for tumor size (ICC = 0.991; 95% CI 0.982–0.996), fair for VI-RADS (K = 0.52, 95% CI, 0.22–0.82), and moderate for others (K = 0.61–0.79). Conclusion In patients with IDBT, several MRI features were significantly associated with overall survival. Utilizing all available clinicopathological and imaging information may improve estimation of prognosis.

OBJECTIVES To assess the efficacy of preoperative bilateral paravertebral block (PVB) with general anesthesia (GA) in contributing to early extubation and decreasing opioid consumption in cardiac surgery. DESIGN A propensity score-matched retrospective study. SETTING A single tertiary medical center between January 2018 and December 2020. PARTICIPANTS Adult patients undergoing isolated first-time aortic valve replacement and coronary artery bypass grafting with full sternotomy. INTERVENTIONS A cohort of 44 patients who received PVB with GA (PVB group) was matched with 44 patients who underwent similar surgery with GA only (GA only group). MEASUREMENTS AND MAIN RESULTS The completion rate of extubation in the operating room was significantly greater in the PVB group (65.9%) than in the GA only group (43.2%; p = 0.032). The completion rate of extubation within eight hours after surgery also was significantly greater in the PVB group (86.4%) than in the GA only group (68.2%; p = 0.042). The median amount of intraoperative fentanyl administered was significantly less in the PVB group (4.8 µg/kg; interquartile range [IQR], 3.3-7.2) than in the GA only group (8.4 µg/kg; IQR, 5.4-12.7; p < 0.001). The median amount of postoperative fentanyl administered was significantly less in the PVB group (6.8 µg/kg; IQR, 3.9-10.6) than in the GA only group (8.1 µg/kg; IQR, 6.2-15.9; p = 0.012). CONCLUSIONS This study demonstrated that preoperative bilateral PVB combined with GA contributed to early extubation in isolated first-time aortic valve replacement and coronary artery bypass grafting and in the reduction of intraoperative and postoperative fentanyl consumption.

Objectives: Guidelines do not distinguish between 50 mg or 100 mg nitrofurantoin as daily prophylaxis for recurrent urinary tract infection (UTI), although 50 mg might have a better safety profile. Our objective was to compare the effectiveness and safety of both regimens. Methods: Data were retrospectively collected from 84 Dutch GP practices between 2013 and 2020. Nitrofurantoin prescriptions of 100 mg and 50 mg every 24 hours in women were included. Cox proportional hazard regression analysis was used to calculate hazard ratios on first episode of UTI, pyelonephritis and (adverse) events. Patients were followed for the duration of consecutive repeated prescriptions, assuming non-informative right censoring, up to 1 year. Results: Nitrofurantoin prophylaxis was prescribed in 1893 patients. Median lengths of follow up were 90 days (interquartile range (IQR) 37–179 days) for 100 mg (n = 551) and 90 days (IQR 30–146 days) for 50 mg (n = 1342) with few differences in baseline characteristics between populations. Under 100 mg and 50 mg, 82/551 (14.9%) and 199/1342 (14.8%) developed UTI and 46/551 (8.3%) and 81/1342 (6.0%) developed pyelonephritis, respectively. Adjusted HRs of 100 mg versus 50 mg were 1.01 (95% CI 0.78–1.30) on first UTI, 1.37 (95% CI 0.95–1.98) on first pyelonephritis episode, 1.82 (95% CI 1.20–2.74) on first consultation for cough, 2.68 for dyspnoea (95% CI 1.11–6.45) and 2.43 for nausea (95% CI 1.03–5.74). Conclusion: Daily prophylaxis for recurrent UTI with 100 mg instead of 50 mg nitrofurantoin was associated with an equivalent hazard on UTI or pyelonephritis, and a higher hazard on cough, dyspnoea and nausea. We recommend 50 mg nitrofurantoin as daily prophylaxis.

Background A socioeconomic gradient exists in the utilisation of total hip replacements (THR) and total knee replacements (TKR) for osteoarthritis. However, the relations between socioeconomic status (SES) and time to THR or TKR is unknown. Aim To describe the association between SES and time to THR and TKR. Methods 1072 older-adults residing in Tasmania, Australia were studied. Incident primary THR and TKR were determined by data linkage to the Australian Orthopaedic Association National Joint Replacement Registry. At baseline, each participant's area-level SES was determined by the Index of Relative Socioeconomic Advantage and Disadvantage (IRSAD), from the Australian Bureau of Statistics' 2001 census data. IRSAD was analysed in two ways; 1) categorised into quartiles, whereby quartile 1 represented the most socioeconomically disadvantaged group, 2) the cohort dichotomised at the quartile 1 cut-point. Results The mean age was 63.0 (±7.5) years, and 51% were women. Over the median follow-up of 12.9 (Interquartile range: 12.2-13.9) years, 56 (5%) participants had a THR, and 79 (7%) had a TKR. Compared to the most disadvantaged quartile, less disadvantaged participants were less likely to have a THR (i.e. less disadvantaged participants had a longer time to THR) (HR: 0.56, 95% CI 0.32, 1.00) but not TKR (HR: 0.90, 95% CI 0.53, 1.54). However, the former became non-significant after adjustment for pain and radiographic osteoarthritis, suggesting that the associations may be mediated by these factors. Conclusions This study suggests that time to joint replacement was determined according to the symptoms/need of the participants rather than their SES. This article is protected by copyright. All rights reserved.

Background & Aims Porto-sinusoidal vascular disease (PSVD) was recently proposed as novel clinical entity characterized by typical histological changes with or without portal hypertension (PH) in the absence of cirrhosis. Thus, we aimed to describe clinical characteristics and the outcome of PSVD patients and to compare these to patients meeting traditional idiopathic non-cirrhotic portal hypertension (INCPH) criteria. Methods Patients undergoing liver biopsy (baseline) ±hepatic venous pressure gradient (HVPG) measurement at the Vienna General Hospital between 2000-2019 were screened for PSVD and INCPH criteria. Results 91 patients were diagnosed with PSVD of which 28 (30.8%) also fulfilled INCPH criteria (INCPH+/PSVD+). Specific histological and specific clinical PH signs were found in 72 (79.1%) and 54 (59.3%) patients, respectively. INCPH+/PSVD+ showed higher Child-Pugh-scores (7±2 vs 6±1 points; P = .002) and a higher prevalence of decompensation (57.1% vs 28.6%; P = .009) than INCPH-/PSVD+ patients. Importantly, hepatic decompensation after three years (3Y) occurred in 11.2% of PSVD patients with specific clinical signs of PH, while no decompensation occurred in patients with only specific histological or with unspecific clinical/histological signs (P = .002). When categorizing by INCPH definition, 3Y decompensation was 13.4% in INCPH+/PSVD+ and 3.8% in INCPH-/PSVD+ (P = .120). While overall mortality was similar in INCPH+/PSVD+ (n = 6; 21.4%) and INCPH-/PSVD+ (n = 10; 15.9%) patients (P = .558), liver-related mortality tended to be higher in INCPH+/PSVD+ (6.9%) than in INCPH-/PSVD+ (0%; P = .078). Conclusion Novel PSVD criteria facilitate diagnosis. Compared to INCPH, clinical course of PSVD patients is more favorable. Importantly, specific signs of PH including varices and collaterals are associated with hepatic decompensation and mortality.

Re-operative aortic arch operations (REDO) following previous cardiac surgery are challenging procedures associated with significant morbidity and mortality. We investigated post-operative outcomes for patients undergoing REDO and identified risk-factors for mortality in a contemporary series. From 1/2005-6/2018, 365 consecutive patients at an academic center underwent REDO: 257 HEMIARCH and 108 COMPLETE arch (45 stage I elephant trunk, 63 total arch) replacements. Outcomes included mortality and major adverse events. Long-term survival was determined with Kaplan-Meier analysis, and risk-factors for mortality were assessed with Cox proportional hazards regression. Operative mortality for the entire cohort was 6.8%, and rates of stroke, cardiac arrest, and renal failure were 6.0%, 7.4%, and 10.4%. Compared to HEMIARCH, COMPLETE patients had an increased incidence of renal failure requiring dialysis (15.7% vs 8.2%, p = 0.031) and re-exploration for bleeding or delayed chest closure (19.4% vs. 11.7%, p = 0.051). Although operative mortality was similar in both cohorts, long-term follow-up mortality (38.0% vs 26.8%, p = 0.047) was higher among COMPLETE vs. HEMIARCH. Predictors of overall mortality among all-comers undergoing REDO included older age, low body surface area, endocarditis, ejection fraction30%, emergent status of operation, extended cardiopulmonary bypass duration, intra-aortic balloon pump use, and a more extensive arch operation. Previous aortic surgery was not a risk-factor for mortality. Among all-comers undergoing REDO, survival was 81.4% at 1 year, 66.7% at 5 years, and 56.4% at 10 years of follow-up. While early postoperative outcomes are similar among HEMIARCH and COMPLETE, a more extensive arch-replacement is an independent risk-factor for overall mortality in REDO. Using appropriate clinical indications in the current era, REDO remains a viable option for selected patients.

The edge-to-edge mitral valve repair technique, invented by Alfieri and colleagues, introduced valve repair as a treatment option for patients with complex diseases where standard annuloplasty and related repair techniques are insufficient, due to annular calcification and patient frailty. We retrospectively evaluated the results of a transaortic edge-to-edge mitral valve repair (Alfieri stitch) in high-risk patients who were undergoing aortic valve replacement. From February, 2012 to December, 2017, 43 patients underwent transaortic edge-to-edge mitral valve repair with concomitant aortic valve replacement at a single institution. Preoperative and postoperative echocardiograms were compared. Home telephone follow up was conducted and postoperative morbidity was examined, including the need for reoperation, stroke and cardiac arrhythmia. 30-day and long-term survival rates were also determined. Mitral regurgitation (MR) was graded semi-quantitatively as 0 (trace and/or none), mild (1), moderate (2) or moderate to severe (3-4). The patients were 74 ± 7.8 years old. 65% of the patients were male. Mean cardiopulmonary bypass time was 115 ± 37 minutes and mean cross-clamp time was 71 ± 23 minutes. There was a significant improvement in preoperative vs postoperative median MR grade (2 (IQR 2-3) vs 0 (IQR 0-1); P = 0.05). Follow-up transthoracic echocardiograms in 29 patients obtained at a median of 9 months' (range 3 - 19 months') and in 16 patients at a median of 34 months' postoperatively (range 21 - 53 months') showed mild (1 (IQR 1-2)) grade of mitral regurgitation. 30-day survival was 98%. Long term survival at 12 and 24 months' were 88% and 81% respectively. Mitral valve reoperation was conducted in 1 patient (2%), who was suffering of endocarditis. Stroke occurred in 2 patients (7%). Cardiac arrhythmia was observed in 15 patients (35%). 8 patients (19%) suffered from atrial fibrillation and 7 patients (16%) displayed atrioventricular blockage. 10 patients (23%) could be treated conservatively and 5 patients (12%) needed implantation of a pacemaker. Transaortic edge-to-edge mitral valve repair can be safely performed during aortic valve replacement in high-risk patients and improves even long-term MR grade. Postoperative cardiac arrhythmia occurs frequently. 66% of them could be treated successfully by conservative procedures.

Aim of this retrospective, multicenter study was to evaluate early and mid-term clinical and hemodynamic results of patients who underwent surgical aortic valve replacement (SAVR) with Intuity rapid-deployment bioprostheses (RDB) (Edwards Lifesciences, Irvine, CA). We analyzed data from the Italian Registry of Intuity Valve (INTU-ITA registry) that is a national, real-world and independent from the industry registry. Preoperative variables were defined according to EuroSCORE and postoperative outcomes according to Valve Academic Research Consortium (VARC). Survival distribution was evaluated using the Kaplan-Meier approach. A Cox-Proportional Hazard Model was employed to assess the effect of the covariates on patients’ survival. The registry included 1687 patients from 23 centers (June 2012-September 2019). Aortic cross clamp time for isolated SAVR was 55 minutes (IQR: 45–70 minute). Postoperative pace-maker rate was 6.3%. At discharge transaortic peak and mean gradients were: 18 mm Hg (IQR: 14–23 mm Hg) and 10 mmHg (IQR: 8–13 mm Hg), respectively. Indexed effective orifice area was 1.10 cm2/m2 (IQR: 0.91–1.31 cm2/m2) and the incidence of severe patient-prosthesis mismatch was 0.6%. Hemodynamic data for all valve sizes remained stable during follow-up. Thirty-day overall mortality was 1.8% (30 patients), and at follow-up it was 5.3% (89 patients). Kaplan-Meier overall survival was 95.5% (94.3–96.7%); 90.7% (88.3–93.1%); 86.4% (82.6–90.4%) at 1, 3, and 5 years, respectively. Serum creatinine (HR: 1.36; 95%CI: 1.04–1.81; p = 0.0397) and cross-clamp time (HR: 1.01; 95%CI: 1.002–1.017; p = 0.0077) were identified as independent predictors of mortality. According to our data from the INTU-ITA registry, SAVR with RDB provides good early clinical and hemodynamic results that are confirmed at follow-up.

Prior thoracic radiation has been associated with worse outcomes after cardiac surgery. This study sought to report long-term outcomes in patients undergoing surgery for radiation-associated heart disease. This was an observational study of open cardiac surgeries from 2011 and 2018. Patients with a history of malignancy that required thoracic radiation were identified, and this cohort was matched against a non-irradiated comparison group via Mahalanobis distance matching. Kaplan-Meier survival estimation and multivariable Cox regression analysis was performed to assess the long-term impact of thoracic radiation in patients undergoing cardiac surgery. Of the 15,284 patients receiving cardiac surgery in this time-frame, 269 were identified with a history of thoracic radiation for prior malignancy. Patients with prior radiation had increased 1-year and 5-year mortality (P0.001), despite no difference for 30-day mortality (P = 0.719), compared to non-irradiated patients. Mahalanobis distance matching yielded 269 equitably matched pairs. On multivariable analysis, patients with prior radiation demonstrated significantly increased hazard of death, as compared to the non-irradiated group (hazard ratio 1.40, 95% confidence interval: 1.02, 1.94, P = 0.038). Patients with radiation for breast cancer demonstrated a non-significant trend toward reduced hazard of death, as compared to patients with more extensive radiation exposure. There was an increase in long-term mortality in patients with prior radiation undergoing cardiac surgery, however open cardiac surgery can safely be performed in these patients with similar operative mortality. These findings may serve as a useful adjunct in shared decision-making for patients and surgeons alike.

We examined the long-term fate of the preserved aortic root after emergent repair of acute Type A aortic dissection. 144 patients (60% males, mean age 60.5 years) underwent supracoronary ascending aortic replacement for acute Type A aortic dissection. Long-term survival, as well as growth, reoperation, and adverse events of the aortic root (rupture, pseudoaneurysm, and persistent dissection) were retrospectively assessed. Operative mortality was 9%, and overall survival at 1, 5, and 10 years was 87.8%, 76.4%, and 64.6%, respectively. Reoperation on the proximal aorta was performed in 16 patients (12.2%) within a median of 2.45 years post-operatively. Indications were severe aortic insufficiency (AI) (n = 6), aortic root pseudoaneurysm (n = 8), pseudoaneurysm with severe AI (n = 1), and persistent dissection with severe AI (n = 1). The aortic root grew at 0.2mm/year (interquartile range 0-0.8). Among survivors (n = 131), 28 patients (21.3%) reached aortic root diameter ≥ 45 mm (mean diameter 47.6 mm, range 45-54 mm). Survival free from proximal aortic reoperation at 1, 5, and 10 years was 96.6%, 94.5%, and 92.2%, respectively. No non-reoperated patient-despite persistent, unoperated enlargement or distortion or pseudoaneurysm of the aortic root-developed free rupture or fistula to a cardiac chamber. Root-sparing ascending aortic replacement for acute Type-A aortic dissection showed satisfactory long-term outcomes with relatively low rates of re-intervention or serious aortic root adverse events despite dilatation and irregularity of aortic root contour. Dense adhesions from prior surgery, proximal aortic suture line, and Teflon felt seem to discourage free rupture or fistulization.

The 4Ts and HIT-Expert Probability (HEP) scoring tools for heparin-induced thrombocytopenia (HIT) have not been validated in cardiac surgery patients, and the reported sensitivity and specificity of the Post-Cardiopulmonary Bypass (CPB) scoring tool vary widely in the 2 available analyses. It remains unclear which of the available scoring tools most accurately predicts HIT in this population. Forty-nine HIT-positive patients who underwent on-pump cardiac surgery within a 6-year period were loosely matched to 98 HIT-negative patients in a 1:2 case-control design. The 4Ts, HEP, and CPB scores were calculated for each patient. Sensitivity and specificity of each tool were calculated using standard cut-offs. The Youden method was utilized to determine optimal cut-offs within receiver operating characteristic (ROC) curves of each score, after which sensitivities and specificities were recalculated. Using standard cut-offs, the sensitivities for the CPB, HEP, and 4Ts scores were 100%, 93.9%, and 69.4%, respectively. Specificities were 51%, 49%, and 71.4%, respectively. The AUC of the scoring tool ROC curves were 0.961 for the CPB score, 0.773 for the HEP score, and 0.805 for the 4Ts score. Using the Youden method-derived optimal cut-off of ≥3 points on the CPB score, sensitivity remained 100% with improved specificity to 88.9%. The CPB score is the preferred HIT clinical scoring tool in adult cardiac surgery patients, whereas the 4Ts score performed less effectively. A cut-off of ≥ 3 points on the CPB score could increase specificity while preserving high sensitivity, which should be validated in a prospective evaluation.

Background Better insights into the natural course of cystic fibrosis (CF) have led to treatment approaches that have improved pulmonary health and increased the life expectancy of affected individuals. This study evaluated how the combination of modified demographics and changes in CF management impacted resource consumption and the cost of care. Methods Medical records of CF patients from 2006 to 2016 in the French CF Registry were linked to their corresponding claims data (SNDS). Medications, medical visits, procedures, hospitalisations, and indirect costs were annualized by calendar year from 2006 to 2017. Results Of the 7,671 patients included in the French CF Registry, 6,187 patients (80.7%) were linked to the SNDS (51.9% male, mean age = 24.7 years). The average cost per patient was €14,174 in 2006, €21,920 in 2011 and €44,585 in 2017. Costs associated with hospital stays increased from €3,843 per patient in 2006 to €6,741 in 2017. In 2017, the mean cost per CF patient was allocated as follows: 72% for medications (of which 51% for modulator therapies), 15% for hospital stays, 7% for medical visits, 3% for indirect costs, 2% for medical devices, 1% for outpatient medical procedures. Conclusion There was a strong increase in the mean annual cost per CF patient between 2006 and 2017, mostly due to the cost of therapy after the introduction of cystic fibrosis transmembrane conductance regulator (CFTR) modulators. The combination of an increase in the number of CF patients – particularly adult patients – and an increase in the annual cost per patient led to a substantial increase in the total cost of CF disease care for the health systems.

Objective To describe the current system of pediatric asthma care and identify potential options for unloading tertiary centers. Methods Retrospective, cross-sectional study using 2014 inpatient and emergency department all-encounter administrative datasets from Arkansas, Florida, Kentucky, Maryland, Massachusetts, and New York. Study participants included children Results There were 174,239 encounters for pediatric asthma, with 26,316 admissions and 3101 transfers. About 94.4% of transfers were admitted, with median stay length 2 days (interquartile range [IQR] 1.0–3.0). About 637 hospitals saw pediatric asthma, but 58.7% never admitted these patients. Fifty-four hospitals (8.5%) regularly received transfers; these hospitals were broadly capable pediatric centers (mean pediatric hospital capability indices = 0.82, IQR: 0.64–0.89). Two hundred nine facilities (32.8%) did not regularly receive transfers but were highly capable of caring for pediatric asthma (mean condition-specific capability = 0.92, IQR: 0.85–1.00). Median distance from transferring hospitals to the nearest pediatric center was 25.7 miles (IQR: 6.45–50.15) vs 18.0 miles (IQR: 8.35–29.25) to the nearest potential receiving hospital. Mean cost of a 2-day asthma admission in receiving hospitals was $3927 (IQR: $3083–$4894) versus $3427 (IQR: $2485–$4102) in potential receivers. Conclusions While nearly all acute care hospitals encounter children with asthma, more than half never admit them. Children are primarily transferred to a small subset of specialized centers, despite the existence, in many regions, of closer community hospitals with high pediatric asthma capability. In settings with long transfer distances and tertiary center crowding, a tiered system of hospital care for pediatric asthma may be feasible.

Background Self-care behavior is important in avoiding hospitalization for patients with heart failure (HF) and refers to those activities performed with the intention of improving or restoring health and well-being, as well as treating or preventing disease. The purpose was to study the effects of a home-based mobile device on self-care behavior and hospitalizations in a representative HF-population. Methods and Results SMART-HF is a randomized controlled multicenter clinical trial, where patients were randomized 1:1 to receive standard care (control group [CG]) or intervention with a home-based tool designed to enhance self-care behavior (intervention group [IG]) and followed for 240 days. The tool educates the patient about HF, monitors objective and subjective symptoms and adjusts loop diuretics. The primary outcome is self-care as measured by the European Heart Failure Self-care behavior scale and the secondary outcome is HF related in-hospital days.A total of 124 patients were recruited and 118 were included in the analyses (CG: n = 60, IG: n = 58). The mean age was 79 years, 39% were female, and 45% had an ejection fraction of less than 40%. Self-care was significantly improved in the IG compared to the CG (median (interquartile range) (21.5 [13.25; 28] vs 26 [18; 29.75], p = 0.014). Patients in the IG spent significantly less time in the hospital admitted for HF (2.2 days less, relative risk 0.48, 95% confidence interval 0.32–0.74, P = .001). Conclusions The device significantly improved self-care behavior and reduced in-hospital days in a relevant HF population.

Objectives This study sought to evaluate the impact of post-stent optical coherence tomography (OCT) findings, including severe malapposition, on long-term clinical outcomes. Background Suboptimal OCT findings following percutaneous coronary intervention (PCI) are highly prevalent; however, their clinical implications remain controversial. Methods Of the patients registered in the Yonsei OCT registry, a total of 1,290 patients with 1,348 lesions, who underwent OCT immediately post-stenting, were consecutively enrolled for this study. All patients underwent implantation of drug-eluting stents. Post-stent OCT findings were assessed to identify predictors of device-oriented clinical endpoints (DoCE), including cardiac death, target vessel-related myocardial infarction (MI) or stent thrombosis, and target lesion revascularization (TLR). Significant malapposition criteria associated with major safety events (MSE) were also investigated, such as cardiac death, target vessel-related MI, or stent thrombosis. Results The median follow-up period was 43.0 months (interquartile range [IQR] 21.4 to 56.0 months). The incidence rates of stent edge dissection, tissue prolapse, thrombus, and malapposition after intervention were not associated with occurrence of DoCE. However, patients with significant malapposition (total malapposition volume [TMV] ≥7.0 mm3] exhibited more frequent MSE. A smaller minimal stent area (MSA) was identified as an independent predictor for DoCE (hazard ratio [HR]: 1.20 [95% confidence interval [CI]: 1.00 to 1.43]; p = 0.045). Malapposition with TMV ≥7.0 mm3 was found to be an independent predictor of MSE (HR: 6.12 [95% CI: 1.88 to 19.95]; p = 0.003). Follow-up OCT at 3, 6, or 9 months after PCI showed that post-stent TMV ≥7.0 mm3 was related to a greater occurrence of late malapposition and uncovered struts. Conclusions Although most suboptimal OCT findings were not associated with clinical outcomes, a smaller MSA was associated with DoCE, driven mainly by TLR, and significant malapposition with TMV ≥7.0 mm3 was associated with more MSE after PCI. (Yonsei OCT [Optical Coherence Tomography] Registry for Evaluation of Efficacy and Safety of Coronary Stenting; Yonsei OCT registry; NCT02099162 )

Objective Venous insufficiency is often not readily recognized as a contributing etiology to nonhealing wounds by nonvascular surgery specialists, potentially delaying appropriate treatment to achieve wound healing and increasing healthcare costs. The objective of the present study was to understand the time and resources used before the definitive treatment of venous ulcers. Methods A single-institution retrospective medical record review of C6 patients undergoing radiofrequency saphenous and perforator vein ablation from May 2016 to January 2018 identified 56 patients with 67 diseased limbs. The numbers of inpatient, emergency department, and wound care visits and the intervals to vein ablation from the initial evaluation of the ulceration by a healthcare provider were collected. The demographics, comorbidities, previous venous interventions, wound characteristics, duplex ultrasound imaging, and available wound healing follow-up through July 2018 were assessed for all patients. Results For the 67 limbs examined, 588 total healthcare visits were performed for wound assessment before a referral to a vascular surgeon, with 413 visits at a wound care center (70% of all visits). Other specialty visits included emergency medicine (17.9% of limbs) and rheumatology (22.4% of limbs). Six patients (nine limbs) were admitted to inpatient services for treatment of their ulceration. Overall, the patients were seen an average of 8.6 ± 9.7 times for their ulcer with the wound center before determination of a contributing venous etiology and subsequent treatment. These visits translated to a median of 230 days (interquartile range, 86.5-1088 days) between the first identification of the ulcer by healthcare providers and subsequent accurate diagnosis and definitive treatment of their venous disease with radiofrequency saphenous and perforator vein ablation. After intervention, 18.64% of the limbs had healed at 1 month, 33.92% had healed at 3 months, 50% had healed at 6 months, and 82.92% had healed by 12 months. Conclusions An earlier and accurate diagnosis of the venous contribution to ulcers and subsequent appropriate treatment of venous etiologies in wound formation by a vascular venous specialist could significantly improve healing and minimize resource usage.

Multiple fixation techniques for first metatarsophalangeal joint arthrodesis have been described with an average fusion rate of 93.5%. This retrospective cohort study assesses the association between crossed screws (vs dorsal plating) and medical comorbidities and the outcome radiographic union. Bivariate tests of association and multivariable logistic regression were employed to assess differences across fixation type and outcomes. We identified 305 patients who underwent a first metatarsophalangeal joint arthrodesis during the study period. Crossed screw fixation was used in 158 (51.8%) patients while dorsal plating (tubular or anatomic locking plate) was used in 147 (48.2%) patients. Dorsal plating was utilized more often in patients with rheumatoid arthritis (p = .019) and history of smoking (p = .044). At 12 weeks post-operatively there were no significant differences in fusion rates between the two groups (crossed screw group = 95.3% vs dorsal plate group (referent) = 93.5%, Adjusted odds ratio (AOR) 1.39, 95% confidence interval [CI] 0.45-4.26). Not smoking was associated with a greater odds of fusion at 12 weeks (96.2% for nonsmokers vs 75.0% for smokers (referent), AOR 0.07, 95% CI 0.02-0.28). Lower body mass index was associated with a greater odds of fusion at 12 weeks (AOR 0.90, 95% CI 0.82-0.99). Surgeons allowed weightbearing earlier with dorsal plate fixation (2 weeks (interquartile range [IQR] 2.6) versus 5 weeks (IQR 2.6) for crossed screw fixation, p = .001). Patients with multiple medical comorbidities were more likely to require revision surgery than patients having 0-1 comorbidities (p.05). Crossed screws can provide an inexpensive yet effective option for first metatarsophalangeal joint arthrodesis.

Purpose To compare the efficacy and safety of early versus later ab interno gelatin microstent placement with mitomycin C. Design Canada-wide, multicenter, retrospective propensity score-matched cohort study. Participants Two hundred seventy eyes (135 early cases and 135 later cases) with no prior incisional surgery. Methods Surgeons’ first 20 patients (early cases group), from 6 glaucoma surgeons across 4 Canadian sites, were matched 1:1 to patients with the closest propensity score from the later (21+) patients (later cases group). Main Outcome Measures Primary outcome was hazard ratio (HR) of failure of the early versus later cases groups, with failure defined as IOP of less than 6 mmHg with more than 2 lines of vision loss or more than 17 mmHg with no medications (complete success) on 2 consecutive visits despite in-clinic maneuvers (including needling) more than 1 month after surgery. Secondary outcomes were HRs for failure, defined as IOP outside the range of 6 to 14 mmHg and 6 to 21 mmHg with and without allowing for medications (qualified success), interventions, complications, and reoperations. Results Hazard ratio of failure for early versus later cases groups was 1.38 (95% confidence interval [CI], 0.97–1.96) for the IOP range of 6 to 17 mmHg, 1.29 (95% CI, 0.90–1.84) for 6 to 14 mmHg, and 1.48 (95% CI, 1.03–2.13) for 6 to 21 mmHg without medication and 0.95 (95% CI, 0.55–1.64), 0.95 (95% CI, 0.61–1.48), and 0.95 (95% CI, 0.52–1.75) for the same IOP ranges allowing for medications. Needling rates were 43.0% (early cases group) and 41.5% (later cases group). Complication rates after 1 month occurred in 9.6% (early cases group) and 11.1% (later cases group; P = 0.69). Reoperation rates were 14.8% (early cases group) and 8.1% (later cases group; P = 0.08). Conclusions There is some evidence for improved success in the later cases group. Similar needling rates, similar complication rates, and a slightly higher reoperation rate were found for the early cases group. The results suggest that this procedure can be adopted by existing surgeons with current training regimens, although they may see an improvement in their success outcomes over time.

Thrombus formation is a feared complication following bidirectional cavopulmonary shunt (BCPS). We aimed to investigate the effect of thrombus formation on outcome. BCPS was performed in 525 patients at our center between 1998 and 2018. The impacts of thrombus formation on survival and probability of Fontan completion were analyzed, and risk factors for thrombus formation were examined. Thrombus formation occurred in 30 patients (5.7%). Compared with the remaining 495 patients, there was no significant difference in the median age at BCPS (4.9 vs 4.7 months; P = 0.587). However, unbalanced atrioventricular septal defects (17 vs 5%; P = 0.008) and preoperative ventricular dysfunction (23.3 vs 8%; P = 0.004) were more frequent in patients who developed a thrombus. Thrombolytic therapy was performed in all patients and surgical thrombus removal was required in 13 patients. In-hospital mortality was higher in patients with thrombus (30.0 vs 2.2%; P0.001). Of 505 hospital survivors, an estimated survival at 1 year after hospital discharge following BCPS was 84.4% (95% CI, 76.1-92.7%) in patients with thrombus and 96.8% (95% CI, 96.0-97.6%) in those without (P0.001). Cumulative incidence of Fontan completion at 3 years after BCPS was 52.8% (95% CI, 30.3-75.2%) in patients with thrombus and 90.1% (95% CI, 87.2-92.9%) in those without (P = 0.004). Higher left atrial pressure (OR = 1.165; P = 0.029) and longer cardiopulmonary bypass time (OR = 1.013, P = 0.001) at BCPS were independent risk factors for thrombus formation after BCPS. Thrombus formation after BCPS poses a significant risk for survival and Fontan completion. Preoperative higher left atrial pressure and longer cardiopulmonary bypass time are significant risk factors.

BackgroundThe majority of combat deaths occur in the prehospital setting. Efforts to increase survival including blood transfusions are made in the prehospital setting. The blood products available in the Role 1 setting include whole blood (WB), red blood cells (RBCs), fresh frozen plasma (FFP), and lyophilized (freeze-dried) plasma (FDP).MethodsThis is a secondary analysis of a previously published dataset within the Prehospital Trauma Registry (PHTR) from 2003 through May 2019. Deterministic linking was used when possible with the DoD Trauma Registry for outcome data. Descriptive statistics were used to analyze the data.ResultsWe identified 1,357 patient encounters in the PHTR. Within that group, 28 patients received a prehospital blood product, with 41 total administrations: WB (18), RBCs (12), FFP (6), FDP (3), and blood not otherwise specified (2). Outcome data were available for 17 of the 28 patients. The median injury severity score was 20, with the thorax being the most frequent seriously injured body region. Most (94%) patients survived to discharge. The median ICU days was 11 (Interquartile Range [IQR] 3-19), and the median hospital days was 19 (IQR 8-29). The average volume (units) of RBCs was 6.0 (95% CI 1.9-10.1), WB 2.8 (95% CI 0.0-5.6), platelets 0.7 (95% CI 0.0-1.4), and FFP 5.0 (95% CI 1.2-8.8).ConclusionsThe use of prehospital blood products is uncommon in U.S. combat settings. Patients who received blood products sustained severe injuries but had a high survival rate. Given the infrequent but critical use and potentially increased need for adequate prolonged casualty care in future near-peer conflicts, optimizing logistical chain circulation is required.

Connective tissue disorders (CTDs) are associated with esophageal dysmotility and gastroesophageal reflux disease, which may diminish survival after lung transplantation (LTx). We studied LTx outcomes in patients with a CTD stratified by esophageal motility. We identified patients who underwent bilateral LTx from 2012 to 2017. Patients with a CTD were classified by pre-LTx diagnosis: absent esophageal motility (AEM), ineffective esophageal motility (IEM), or preserved esophageal motility (PEM). The primary endpoint was 3-year survival. Sub-analysis compared survival between the AEM group and a propensity-matched (lung allocation score), non-CTD control group. Kaplan-Meier method and log-rank test were used. In total, 495 patients underwent LTx; 33 (6.7%) had a CTD. Median (IQR) age was 62 years (55.5-67.0); 24 (72.7%) were women. Survival trended lower for recipients with a CTD than without a CTD at 1-year (84.8% vs 91.8%; p = 0.2) and 3-years (66.7% vs 73.5%; p = 0.5). Within the CTD cohort, 1- and 3-year survival was significantly higher in the PEM (100%, 87.5%) and IEM (100%, 85.7%) groups than in the AEM group (50%, 20%; p0.001). The AEM group had significantly lower survival at 1-year (50% vs 92.5%) and 3-years (20% vs 65%) than a lung allocation score-matched cohort of patients without a CTD. LTx recipients with a CTD and AEM had significantly lower survival than those with PEM or IEM as well as significantly lower survival than that of a propensity-matched cohort of patients without a CTD. Patients with a CTD and AEM should be considered for LTx with extreme caution and counseled appropriately.

Despite the rapid adoption of transcatheter aortic replacement (TAVR), surgical TAVR valve explantation (TAVR-explant) and the clinical impact of explanted TAVR device type are not well described.TAVR-explant from 2016 to 2019 was queried using the Society of Thoracic Surgeons (STS) National Database. A total of 483 patients with documented explanted valve type, consisting of 330 (68%) patients with balloon-expandable and 153 (32%) patients with self-expandable devices, were identified. The primary outcome was 30-day mortality. The secondary outcome was the need for any simultaneous procedures with TAVR-explant.The mean age was 72.8 years, 38% of the patients were female, and 51% demonstrated New York Heart Association functional class III to IV symptoms. During TAVR-explant, 63% of patients required other simultaneous procedures, including aortic repair (27%), mitral procedures (22%), coronary artery bypass grafting (15%), and tricuspid procedures (7%). Patients with a self-expandable device underwent more frequent ascending aortic replacement (22% vs 9%; P.001) than those with a balloon-expandable device, whereas the aortic root replacement rate was similar (19% vs 24%; P = .22). The overall 30-day mortality was 18% without differences in the mortality or other major complications between the groups. Of the 157 patients with isolated surgical aortic valve replacement and available STS predicted risk of mortality score, the observed-to-expected (O/E) mortality ratio was 2.2.The TAVR-explant outcomes were comparable between patients with balloon-expandable devices and patients with self-expandable devices, whereas ascending aortic replacement was observed more frequently in patients with self-expandable devices. Younger patients undergoing TAVR should be informed of the future TAVR-explant risk that may accompany a higher O/E ratio and frequent morbid concurrent procedures.

Study Objective To assess the efficacy of a superior hypogastric plexus nerve block in reducing opioid requirements in the first 24 hours after minimally invasive gynecologic surgery. Design Patient-blinded randomized controlled trial. Setting Single-center academic institution (Sydney Women's Endosurgery Centre). Two surgeons administering the blocks in their own surgeries. Patients Patients undergoing either laparoscopic or robot-assisted laparoscopic hysterectomy or myomectomy for benign indications. Interventions Ropivacaine 10 mL (0.75%) infiltrated into the retroperitoneal space overlying the superior hypogastric plexus vs control of no block given at the completion of surgery. Measurements and Main Results The primary outcome was the total opioid use in the first 24 hours after surgery, measured in morphine milligram equivalents (MME). Standardized fentanyl patient-controlled analgesia was given to all patients in the trial. The secondary outcome was pain measured on a visual analog scale (1 to 10) at 1, 2, 6, 12, and 24 hours after surgery. Fifty patients out of 56 approached for the study participated in, and completed, the study (89.2%). The patients were randomized over a 5-month period, March 2020 to July 2020. A total of 27 patients were randomized to receive a nerve block, and 23 were randomized to the control. There was a difference of –21.8 MME in the block group compared with the no-block group (95% confidence interval [CI], –38.2 to –5.5; p = .008). This correlated to a 38% reduction in opioid use in the block group. The mean opioid use in the patients in the block group was 33.1 MME (95% CI, 24.2–41.9) and in those in the no-block group 54.9 MME (95% CI, 40.7–69.1). For the block group, opioid use ranged from 1.0 to 76.5 MME, with an interquartile range of 37 (14–51). For the control group, the range was 7.5 to 113.5 MME, with a higher interquartile range of 60 (28–88). Pairwise comparisons of the mean pain scores over the 24 hours showed a lower pain score with a nerve block of 1.8 (95% CI, 1.5–2.1) compared with a no-block score of 2.6 (95% CI, 2.3–2.9) No adverse effects of local anesthetic toxicity, nerve injury, or bowel/vascular injury were noted in any patient. Conclusion A superior hypogastric plexus nerve block is a simple technique for reducing postoperative opioid requirements and pain in the first 24 hours after minimally invasive gynecologic surgery.

BACKGROUND AND PURPOSE To explore the prevalence, risk factors, time correlation, characteristics and clinical outcome of dural arteriovenous fistulas (dAVFs) in a cerebral venous thrombosis (CVT) population. METHODS We included patients from the International CVT Consortium registries. Diagnosis of dAVF was confirmed centrally. We assessed the prevalence and risk factors for dAVF among consecutive CVT patients and investigated its impact on clinical outcome using logistic regression analysis. We defined poor outcome as modified Rankin Scale score 3-6 at last follow-up. RESULTS dAVF was confirmed in 29/1218 (2.4%) consecutive CVT patients. The median (interquartile range [IQR]) follow-up time was 8��(5-23) months. Patients with dAVF were older (median [IQR] 53��[44-61] vs. 41��[29-53] years; p��30 days: 39% vs. 7%; p��

International audience; ObjectivesThis study aimed at investigating the additional contribution of coronary artery calcium (CAC) score to SAFEHEART (Spanish Familial Hypercholesterolemia Cohort Study) risk equation (SAFEHEART-RE) for cardiovascular risk prediction in heterozygous familial hypercholesterolemia (HeFH).BackgroundCommon cardiovascular risk equations are imprecise for HeFH. Because of the high phenotype variability of HeFH, CAC score could help to better stratify the risk of atherosclerotic cardiovascular disease (ASCVD).MethodsREFERCHOL (French Registry of Familial Hypercholesterolemia) and SAFEHEART are 2 ongoing national registries on HeFH. We analyzed data from primary prevention HeFH patients undergoing CAC quantification. We used probability-weighted Cox proportional hazards models to estimate HRs. Area under the receiver-operating characteristic curve (AUC) and net reclassification improvement (NRI) were used to compare the incremental contribution of CAC score when added to the SAFEHEART-RE for ASCVD prediction. ASCVD was defined as coronary heart disease, stroke or transient ischemic attack, peripheral artery disease, resuscitated sudden death, and cardiovascular death.ResultsWe included 1,624 patients (mean age: 48.5 ± 12.8 years; men: 45.7%) from both registries. After a median follow-up of 2.7 years (interquartile range: 0.4-5.0 years), ASCVD occurred in 81 subjects. The presence of a CAC score of >100 was associated with an HR of 32.05 (95% CI: 10.08-101.94) of developing ASCVD as compared to a CAC score of 0. Receiving-operating curve analysis showed a good performance of CAC score alone in ASCVD prediction (AUC: 0.860 [95% CI: 0.853-0.869]). The addition of log(CAC + 1) to SAFEHEART-RE resulted in a significantly improved prediction of ASCVD (AUC: 0.884 [95% CI: 0.871-0.894] for SAFEHEART-RE + log(CAC + 1) vs AUC: 0.793 [95% CI: 0.779-0.818] for SAFEHEART-RE; P < 0.001). These results were confirmed also when considering only hard cardiovascular endpoints. The addition of CAC score was associated with an estimated overall net reclassification improvement of 45.4%.ConclusionsCAC score proved its use in improving cardiovascular risk stratification and ASCVD prediction in statin-treated HeFH.

PURPOSE: To characterize long-term clinical outcomes of monotherapy selective laser trabeculoplasty (SLT) in Afro-Caribbean patients with open-angle glaucoma (OAG). DESIGN: This was a post hoc analysis of nearly 8 years (median 3.2, interquartile range 2.1–7.1) of pooled data from the West Indies Glaucoma Laser Study (WIGLS) and its preliminary study. METHODS: SETTING: Three eye care practices in Saint Lucia and Dominica. PARTICIPANTS: Afro-Caribbean adults with mild-moderate OAG treated with ≤2 medications (61 in preliminary study, 72 in WIGLS). INTERVENTION: Participants underwent medication washout, baseline IOP determination, and bilateral 360° SLT. Participants were followed for up to 94 months. Repeat SLT was performed according to pre-specified criteria. MAIN OUTCOME MEASURES: The primary outcome was mean intraocular pressure (IOP) reduction from baseline. The secondary outcome was medication-free survival with SLT repeated as needed. RESULTS: The pooled data set included 265 eyes of 133 Afro-Caribbean participants. Mean (standard deviation) baseline IOP was 21.2 (3.4) and 21.2 (3.9) mmHg in right and left eyes, respectively. Over 8 years, mean IOP ranged from 12.8–15.7 mmHg and from 13.1–15.8 mmHg, respectively (p