Citations

AbstractBackgroundUnderstanding the mobility of the midface and the separate contributions of the superficial and deep fat compartments is essential for natural esthetic outcomes following soft tissue filler or fat grafting procedures. A study was designed that used ultrasound imaging to demonstrate in vivo visualization and quantification of distances and movements in the midface.MethodsA total of 48 midfaces of 24 healthy Caucasian volunteers, all naïve of esthetic procedures, (22 females; 46.85 (9.8) years; 22.83 (3.1) kg/m2) were scanned using 18 MHz ultrasound imaging. Distances between bony landmarks (inferior orbital rim, infraorbital foramen) were used as markers to measure the cranial movement of the superficial (superficial nasolabial and superficial medial cheek fat compartment) and the deep (deep pyriform space, deep medial check fat compartment, deep lateral cheek fat compartment) midfacial fat compartments between resting and smiling facial position.ResultsThe superficial midfacial fat compartment moved, on average, 3.7 mm (p < 0.001) cranially, whereas the deep midfacial fat compartments moved, on average, 0.1 mm (p > 0.05) during smiling. No gender differences in mobility were identified (p > 0.05).ConclusionThe results obtained are in line with previous cadaveric investigations and revealed, in a highly statistically significant fashion, that the superficial midfacial fat compartments move in cranial direction whereas the deep fat compartment did not display similar positional changes. These results help to guide facial injectable treatments and to understand why, in the midface, a deep supraperiosteal approach should be favored when augmenting the deep midfacial fat compartments.

AbstractBackgroundAn increasing number of soft tissue filler procedures in the nasal region has been reported. Concomitant with demand, the number of complications has risen due to the difficulty in administering filler in a region where soft tissue layering is complex.ObjectivesThe authors sought to describe the layered soft tissue arrangement of the nose as it relates to the underlying arterial vasculature and to define safer zones for nasal filler enhancement.MethodsA total of 60 (28 males and 32 females) study participants were investigated with respect to their layered anatomy in the midline of the nose utilizing ultrasound imaging. The presence and extent of the layered arrangement was examined as well as the depth of the arterial vasculature.ResultsIn the mid-nasal dorsum, a 5-layer arrangement was observed in 100% (n = 60) of all investigated cases, whereas it was found to be absent in the nasal radix and tip. The 5-layer arrangement showed an average extent of 26.7% to 67.5% in relation to nasal length. The nasal arteries coursed superficially in 91.7% of all cases in the nasal radix, in 80% in the mid-nasal dorsum, and in 98.3% in the nasal tip.ConclusionsSoft tissue filler administration in the nose carries the highest risk for irreversible vision loss compared with any other facial region. The safety of soft tissue filler rhinoplasty procedures is enhanced by knowledge of the layered anatomy of the nose, the location and depth of the major nasal vasculature, and employment of maneuvers to decrease the risk of blindness.

Objective: The aim of this study was to define robust benchmark values for the surgical treatment of perihilar cholangiocarcinomas (PHC) to enable unbiased comparisons. Background: Despite ongoing efforts, postoperative mortality and morbidity remains high after complex liver surgery for PHC. Benchmark data of best achievable results in surgical PHC treatment are however still lacking. Methods: This study analyzed consecutive patients undergoing major liver surgery for PHC in 24 high-volume centers in 3 continents over the recent 5-year period (2014–2018) with a minimum follow-up of 1 year in each patient. Benchmark patients were those operated at high-volume centers (≥50 cases during the study period) without the need for vascular reconstruction due to tumor invasion, or the presence of significant co-morbidities such as severe obesity (body mass index ≥35), diabetes, or cardiovascular diseases. Benchmark cutoff values were derived from the 75th or 25th percentile of the median values of all benchmark centers. Results: Seven hundred eight (39%) of a total of 1829 consecutive patients qualified as benchmark cases. Benchmark cut-offs included: R0 resection ≥57%, postoperative liver failure (International Study Group of Liver Surgery): ≤35%; in-hospital and 3-month mortality rates ≤8% and ≤13%, respectively; 3-month grade 3 complications and the CCI: ≤70% and ≤30.5, respectively; bile leak-rate: ≤47% and 5-year overall survival of ≥39.7%. Centers operating mostly on complex cases disclosed better outcome including lower post-operative liver failure rates (4% vs 13%; P = 0.002). Centers from Asia disclosed better outcomes. Conclusion: Surgery for PHC remains associated with high morbidity and mortality with now the availability of benchmark values covering 21 outcome parameters, which may serve as key references for comparison in any future analyses of individuals, group of patients or centers.

Abstract Aim The aim of this study was to compare long-term all-cause mortality between patients receiving percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) using multiple (MAG) or single arterial grafting (SAG). Methods and results The current study is a post hoc analysis of the SYNTAX Extended Survival Study, which compared PCI with CABG in patients with three-vessel (3VD) and/or left main coronary artery disease (LMCAD) and evaluated survival with ≥10 years of follow-up. The primary endpoint was all-cause mortality at maximum follow-up (median 11.9 years) assessed in the as-treated population. Of the 1743 patients, 901 (51.7%) underwent PCI, 532 (30.5%) received SAG, and 310 (17.8%) had MAG. At maximum follow-up, all-cause death occurred in 305 (33.9%), 175 (32.9%), and 70 (22.6%) patients in the PCI, SAG, and MAG groups, respectively (P &lt; 0.001). Multiple arterial grafting [adjusted hazard ratio (HR) 0.66, 95% confidence interval (CI) 0.49–0.89], but not SAG (adjusted HR 0.83, 95% CI 0.67–1.03), was associated with significantly lower all-cause mortality compared with PCI. In patients with 3VD, both MAG (adjusted HR 0.55, 95% CI 0.37–0.81) and SAG (adjusted HR 0.68, 95% CI 0.50–0.91) were associated with significantly lower mortality than PCI, whereas in LMCAD patients, no significant differences between PCI and MAG (adjusted HR 0.90, 95% CI 0.56–1.46) or SAG (adjusted HR 1.11, 95% CI 0.81–1.53) were observed. In patients with revascularization of all three major myocardial territories, a positive correlation was observed between the number of myocardial territories receiving arterial grafts and survival (P trend = 0.003). Conclusion Our findings suggest that MAG might be the more desirable configuration for CABG to achieve lower long-term all-cause mortality than PCI in patients with 3VD and/or LMCAD. Trial registration Registered on clinicaltrial.gov. SYNTAXES: NCT03417050 (https://clinicaltrials.gov/ct2/show/NCT03417050); SYNTAX: NCT00114972 (https://www.clinicaltrials.gov/ct2/show/NCT00114972).

AbstractObjectivesThe Evolut R FORWARD study confirmed safety and effectivenesss of the Evolut R THV in routine clinical practice out to 1 year. Herein, we report the final 3‐year clinical follow up of the FORWARD study.BackgroundTranscatheter aortic valve replacement (TAVR) is a proven alternative to surgery in elderly patients with symptomatic severe aortic stenosis. Long‐term clinical outcome data with the Evolut R platform are scarce.MethodsFORWARD is a prospective multicenter observational study that evaluated the Evolut R system in routine clinical practice at 53 centres. Eligible patients had symptomatic native aortic valve stenosis or failed surgical aortic bioprosthesis and elevated operative risk per Heart‐Team assessment. TAVR was attempted in 1039 patients.ResultsMean age was 81.8 ± 6.2 years, 64.9% were women, STS score was 5.5 ± 4.5% and 34.2% were frail. Rates of all‐cause mortality and disabling stroke were 24.8% and 4.8% at 3 years. Early need for a new pacemaker implantation after TAVR (all‐cause mortality: with new PPI; 21.0% vs. without; 22.8%, p = 0.55) and the presence of > trace paravalvular regurgitation (all‐cause mortality: no or trace; 22.0% vs. ≥ mild; 25.5%, p = 0.29) did not affect survival. Between 1 and 3 years incidence rates of valve related intervention, endocarditis and clinically relevant valve thrombosis were low.ConclusionsThe Evolut R valve maintained a favorable safety profile through 3 years in routine clinical practice. Rates of transcatheter heart valve‐related adverse events were low.

AbstractPurposeInduction immunosuppression has improved the long‐term outcomes after lung transplant. This is the first report exploring the association of induction immunosuppression with the development of de novo donor‐specific human leukocyte antigen (HLA) antibodies (DSA) in lung transplant recipients (LTR).MethodsSixty‐seven consecutive primary LTR were followed for 3 years posttransplant. A total of 41/67 (61%) LTR‐received induction immunosuppression using a single dose of rabbit Antithymocyte Globulin (rATG; 1.5 mg/kg) within 24 h of transplant. All recipients had a negative flow cytometry crossmatch on the day of transplant. Serum samples at 1, 3, 6, and 12 months posttransplant were assessed for the presence of de novo HLA DSA.ResultsDe novo HLA DSA were detected in 22/67 (32.8%) LTR within 1‐year posttransplant. Of these, 9/41 (21.9%) occurred in the induction therapy group and 13/26 (50%) in the noninduction group. Class II DSA were detected in 3/41 (7.3%) LTR who received induction compared to 9/26 (34.6%) LTR without induction immunosuppression (p = .005). Differences in overall survival or freedom from chronic lung allograft dysfunction rates between the two groups were not statistically significant.ConclusionInduction immunosuppression utilizing a modified regimen of single‐dose rATG is associated with a significant reduction in de novo DSA production in LTR.

Abstract We explored minimal residual disease (MRD) in relapsed/refractory multiple myeloma (RRMM) and transplant-ineligible (TIE) newly diagnosed multiple myeloma (NDMM) using data from 4 phase 3 studies (POLLUX, CASTOR, ALCYONE, and MAIA). Each study previously demonstrated that daratumumab-based therapies improved MRD negativity rates and reduced the risk of disease progression or death by approximately half vs standards of care. We conducted a large-scale pooled analysis for associations between patients achieving complete response or better (≥CR) with MRD-negative status and progression-free survival (PFS). MRD was assessed via next-generation sequencing (10−5 sensitivity threshold). Patient-level data were pooled from all 4 studies and for patients with TIE NDMM and patients with RRMM who received ≤2 prior lines of therapy (≤2 PL). PFS was evaluated by response and MRD status. Median follow-up (months) was 54.8 for POLLUX, 50.2 for CASTOR, 40.1 for ALCYONE, and 36.4 for MAIA. Patients who achieved ≥CR and MRD negativity had improved PFS vs those who failed to reach CR or were MRD positive (TIE NDMM and RRMM hazard ratio [HR] 0.20, P &lt; .0001; TIE NDMM and RRMM ≤2 PL HR 0.20, P &lt; .0001). This benefit occurred irrespective of therapy or disease setting. A time-varying Cox proportional hazard model confirmed that ≥CR with MRD negativity was associated with improved PFS. Daratumumab-based treatment was associated with more patients reaching ≥CR and MRD negativity. These findings represent the first large-scale analysis with robust methodology to support ≥CR with MRD negativity as a prognostic factor for PFS in RRMM and TIE NDMM. These trials were registered at www.clinicaltrials.gov as #NCT02076009, #NCT02136134, #NCT02195479, and #NCT02252172.

Abstract Background The objective assessment of beauty remains challenging despite ongoing research efforts. A new method of objectively determining the aesthetic appeal of body features by analyzing gaze patterns and eye movements has recently been investigated. Objectives The objective of this study was to assess, by means of objective eye-tracking technology, differences in the gaze patterns of observers presented with standardized 3-dimensional images showing different degrees of breast asymmetry. Methods A total of 83 Caucasian study participants with a mean age of 38.60 (19.8) years were presented with 5 images depicting varying degrees of breast asymmetry. In addition to the assessment of eye movements, participants were asked to rate the aesthetic appeal and the asymmetry of the breasts on a 5-point Likert scale. Results Overall, the data showed that participants’ rating of the breasts’ aesthetic appeal was inversely related to the level of asymmetry. The mean [standard deviation] time until fixation was shortest for the image depicting the greatest breast asymmetry (50 cc) at 0.77 [0.7] seconds (P &lt; 0.001). In addition, the mammary region was also viewed longest in this image at 3.76 [0.5] seconds (P &lt; 0.001). A volume difference of 35 cc between breasts deflected the observers’ gaze significantly toward the larger of the asymmetric breasts (P &lt; 0.001). Conclusions Surgeons should focus on achieving symmetric breast volume (ie, differences &lt;35 cc between breasts) to avoid noticeable asymmetry with regard to breast size.

Objective To develop a core outcome set (COS) for randomised controlled trials (RCTs) evaluating the effectiveness of interventions for the treatment of pregnant women with pregestational diabetes mellitus (PGDM). Design A consensus developmental study. Setting International. Population Two hundred and five stakeholders completed the first round. Methods The study consisted of three components. (1) A systematic review of the literature to produce a list of outcomes reported in RCTs assessing the effectiveness of interventions for the treatment of pregnant women with PGDM. (2) A three‐round, online eDelphi survey to prioritise these outcomes by international stakeholders (including healthcare professionals, researchers and women with PGDM). (3) A consensus meeting where stakeholders from each group decided on the final COS. Main outcome measures All outcomes were extracted from the literature. Results We extracted 131 unique outcomes from 67 records meeting the full inclusion criteria. Of the 205 stakeholders who completed the first round, 174/205 (85%) and 165/174 (95%) completed rounds 2 and 3, respectively. Participants at the subsequent consensus meeting chose 19 outcomes for inclusion into the COS: trimester‐specific haemoglobin A1c, maternal weight gain during pregnancy, severe maternal hypoglycaemia, diabetic ketoacidosis, miscarriage, pregnancy‐induced hypertension, pre‐eclampsia, maternal death, birthweight, large for gestational age, small for gestational age, gestational age at birth, preterm birth, mode of birth, shoulder dystocia, neonatal hypoglycaemia, congenital malformations, stillbirth and neonatal death. Conclusions This COS will enable better comparison between RCTs to produce robust evidence synthesis, improve trial reporting and optimise research efficiency in studies assessing treatment of pregnant women with PGDM. Tweetable abstract 165 key stakeholders have developed #Treatment #CoreOutcomes in pregnant women with #diabetes existing before pregnancy.