Abstract Objective To evaluate the role of bioelectrical impedance vector analysis (BIVA) and brain natriuretic peptide (BNP) in detecting peripheral congestion in heart failure (HF). Background ...BIVA/BNP are biomarkers for congestion in acute (ADHF) and chronic HF. Methods 487 ADHF and 413 chronic HF patients underwent BIVA and BNP tests. Results BIVA was more accurate than BNP in detecting peripheral congestion both in ADHF (AUC 0.88 vs 0.57 respectively; p < 0.001) and chronic HF patients (AUC 0.89 vs 0.68, respectively; p < 0.001). In ADHF patients, the optimal BNP cut-off for discriminating presence or absence of edema was >870 pg/mL (PPV = 48% and NPV = 58%) whereas in chronic HF it was >216 pg/mL (PPV = 18% and NPV = 95%). The BIVA detected edema when the vector fell into the lower pole of 75th percentile tolerance ellipse (PPV = 84% and NPV = 78%) in ADHF, the lower pole of 50% (PPV = 68% and NPV = 95%) in chronic HF. Conclusions In HF patients, BIVA is an easy, fast technique to assess peripheral congestion, and is even more accurate than BNP.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK, ZRSKP
In the present report, we have described the use of intravascular lithotripsy angioplasty for heavily calcified occlusions of the infrarenal aorta and its bifurcation in two patients. In the first ...patient, two lithotripsy balloons in kissing conformation were simultaneously used to allow for dilatation of the distal aorta and its bifurcation with preservation of accessory renal artery patency, followed by stenting of the iliac arteries. For the second patient, the infrarenal aorta occlusion was first treated with a single lithotripsy balloon, followed by covered stenting. Intravascular lithotripsy could represent a valid endovascular adjunct to optimize outcomes in the treatment of coral reef aortas and aortic bifurcation occlusion.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Background We conducted a prospective study of the clinical outcomes and health-related quality of life after implantation of the CorCap support device (Acorn Cardiovascular Inc, St Paul, MN) for ...dilated cardiomyopathy. Methods The criteria adopted for CorCap implantation were dilated cardiomyopathy (left ventricular LV end-diastolic diameter ≥ 60 mm, LV ejection fraction ≤ 0.30 and > 0.10), and New York Heart Association functional class II or III despite maximal medical therapy. Echocardiographic follow-up and evaluation with the Short Form-36 questionnaire were performed. Results Included were 39 patients: 5 in New York Heart Association class II and 32 in class III. At 13.3 ± 2.5 months of follow-up, a statistically significant improvement was evident in mean LV volume (LV end-systolic volume from 202 ± 94 to 138 ± 72 ml. p = 0.005) and systolic function (LV ejection fraction from 0.26 ± 0.05 to 0.36 ± 0.05, p < 0.001). The mean LV sphericity index was significantly increased at the end of the follow-up ( p = 0.009). Ischemic etiology, diabetes, advanced age, and LV ejection fraction of less than 0.15 predicted lesser reversal of the LV alterations. Operative mortality was 5.1%. Cumulative follow-up mortality was 10.2%. The average Physical Health domain scores (Physical Functioning, Role Physical, General Health) were improved. Average Mental Health domain scores were also increased. Conclusions The cardiac support device obtains reverse remodelling of the LV and is useful to improve the quality of life of patients with dilated cardiomyopathy and New York Heart Association class III symptoms of heart failure. The integration of different and complementary strategies (cardiac support device and resynchronization therapy) may represent the key to success for more complex patients, although further studies are required.
Abstract A new design for a 3-part ankle replacement was developed in an effort to achieve compatibility with the naturally occurring ligaments of the ankle by allowing certain fibers to remain ...isometric during passive motion. In order to test the design concept clinically, 158 prostheses were implanted in 156 patients within a 9-center trial and were followed up for a mean of 17 (range 6 to 48) months. The mean age at the time of surgery was 60.5 (range 29.7 to 82.5) years. Outcome measures included the American Orthopaedic Foot & Ankle Surgery hindfoot-ankle score and range of motion measured on lateral radiographs of the ankle. The preoperative American Orthopaedic Foot & Ankle Surgery score of 36.3 rose to 74.6, 78.6, 76.4, and 79.0, respectively, at 12, 24, 36, and 48 months. A significant correlation between meniscal bearing movement on the tibial component (mean 3.3 mm; range 2 to 11 mm) and range of flexion at the replaced ankle (mean 26.5°; range 14° to 53°) was observed in radiograms at extreme flexions. Two (1.3%) revisions in the second and third postoperative years necessitated component removal (neither were for implant failure), and 7 (4.4%) further secondary operations were required. The results of this investigation demonstrated that non-anatomic–shaped talar and tibial components, with a fully conforming interposed meniscal bearing, can provide safety and efficacy in the short term, although a longer follow-up period is required to more thoroughly evaluate this ankle implant.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Glucocorticoid administration is not recommended in patients with heart failure because of its related sodium and fluid retention. However, previous experimental and clinical studies have ...demonstrated that glucocorticoids can also induce a diuretic effect and improve renal function in patients with acute decompensated heart failure (ADHF) with refractory diuretic resistance. We report the case of a 65-year-old man with a known diagnosis of aortic stenosis, systolic ventricular dysfunction, and chronic obstructive pulmonary disease who was admitted for ADHF. After 3 days, during which resistance to conventional therapy was observed, intravenous methylprednisolone (60 mg/d) was added to ongoing medical treatment. Three days after the onset of glucocorticoid therapy, daily urine volume progressively increased (up to 5.8 L/d). Concurrently, signs and symptoms of congestion improved, the weight and brain natriuretic peptide plasma levels decreased (−7 kg and −46%, respectively) and glomerular filtration rate increased (+26%). Bioimpedance vector analysis showed a net reduction of fluid content (from 88.4% to 73.6% of hydration at discharge). In conclusion, this case report suggests that in a patient with ADHF and congestion resistant to diuretic therapy, glucocorticoid administration is safe and associated with improvement in congestion, neurohormonal status, and renal function. These data support the possible usefulness of glucocorticoids in this setting.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Satellite-based Earth observations (EO) are an accurate and
reliable data source for atmospheric and environmental science. Their
increasing spatial and temporal resolutions, as well as the seamless
...availability over ungauged regions, make them appealing for hydrological
modeling. This work shows recent advances in the use of high-resolution
satellite-based EO data in hydrological modeling. In a set of six
experiments, the distributed hydrological model Continuum is set up for the
Po River basin (Italy) and forced, in turn, by satellite precipitation and
evaporation, while satellite-derived soil moisture (SM) and snow depths are
ingested into the model structure through a data-assimilation scheme.
Further, satellite-based estimates of precipitation, evaporation, and river
discharge are used for hydrological model calibration, and results are
compared with those based on ground observations. Despite the high density
of conventional ground measurements and the strong human influence in the
focus region, all satellite products show strong potential for operational
hydrological applications, with skillful estimates of river discharge
throughout the model domain. Satellite-based evaporation and snow depths
marginally improve (by 2 % and 4 %) the mean Kling–Gupta efficiency
(KGE) at 27 river gauges, compared to a baseline simulation
(KGEmean= 0.51) forced by high-quality conventional data. Precipitation
has the largest impact on the model output, though the satellite data on
average shows poorer skills compared to conventional data. Interestingly, a
model calibration heavily relying on satellite data, as opposed to
conventional data, provides a skillful reconstruction of river discharges,
paving the way to fully satellite-driven hydrological applications.
To evaluate the effectiveness of radiofrequency (RF) ablation as measured by change in worst pain score from baseline to 3 mo after RF ablation for the palliative treatment of painful bone ...metastases.
One hundred patients (mean age, 64.6 y) underwent RF ablation for metastatic bone disease and were followed up to 6 mo. Subjects’ pain and quality of life were measured before RF ablation and postoperatively by using the Brief Pain Index and European Quality of Life questionnaires. Opioid agent use and device-, procedure-, and/or therapy-related adverse events (AEs) were collected.
Eighty-seven patients were treated for tumors involving the thoracolumbar spine and 13 for tumors located in the pelvis and/or sacrum. All ablations were technically successful, and 97% were followed by cementoplasty. Mean worst pain score decreased from 8.2 ± 1.7 at baseline to 3.5 ± 3.2 at 6 mo (n = 22; P < 0.0001 for all visits). Subjects experienced significant improvement for all visits in average pain (P < .0001), pain interference (P < .0001), and quality of life (P < .003). Four AEs were reported, of which 2 resulted in hospitalization for pneumonia and respiratory failure. All 30 deaths reported during the study were attributed to the underlying malignancy and not related to the study procedure.
Results from this study show rapid (within 3 d) and statistically significant pain improvement with sustained long-term relief through 6 mo in patients treated with RF ablation for metastatic bone disease.
Ramucirumab—an IgG1 vascular endothelial growth factor receptor 2 antagonist—plus docetaxel was previously reported to improve progression-free survival in platinum-refractory, advanced urothelial ...carcinoma. Here, we report the secondary endpoint of overall survival results for the RANGE trial.
We did a randomised, double-blind, phase 3 trial in patients with advanced or metastatic urothelial carcinoma who progressed during or after platinum-based chemotherapy. Patients were enrolled from 124 investigative sites (hospitals, clinics, and academic centres) in 23 countries. Previous treatment with one immune checkpoint inhibitor was permitted. Patients were randomly assigned (1:1) using an interactive web response system to receive intravenous ramucirumab 10 mg/kg or placebo 10 mg/kg volume equivalent followed by intravenous docetaxel 75 mg/m2 (60 mg/m2 in Korea, Taiwan, and Japan) on day 1 of a 21-day cycle. Treatment continued until disease progression, unacceptable toxicity, or other discontinuation criteria were met. Randomisation was stratified by geographical region, Eastern Cooperative Oncology Group performance status at baseline, and visceral metastasis. Progression-free survival (the primary endpoint) and overall survival (a key secondary endpoint) were assessed in the intention-to-treat population. The study is registered with ClinicalTrials.gov, NCT02426125; patient enrolment is complete and the last patient on treatment is being followed up for safety issues.
Between July 20, 2015, and April 4, 2017, 530 patients were randomly allocated to ramucirumab plus docetaxel (n=263) or placebo plus docetaxel (n=267) and comprised the intention-to-treat population. At database lock (March 21, 2018) for the final overall survival analysis, median follow-up was 7·4 months (IQR 3·5–13·9). In our sensitivity analysis of investigator-assessed progression-free survival at the overall survival database lock, median progression-free survival remained significantly improved with ramucirumab compared with placebo (4·1 months 95% CI 3·3–4·8 vs 2·8 months 2·6–2·9; HR 0·696 95% CI 0·573–0·845; p=0·0002). Median overall survival was 9·4 months (95% CI 7·9–11·4) in the ramucirumab group versus 7·9 months (7·0–9·3) in the placebo group (stratified HR 0·887 95% CI 0·724–1·086; p=0·25). Grade 3 or worse treatment-related treatment-emergent adverse events in 5% or more of patients and with an incidence more than 2% higher with ramucirumab than with placebo were febrile neutropenia (24 9% of 258 patients in the ramucirumab group vs 16 6% of 265 patients in the placebo group) and neutropenia (17 7% of 258 vs six 2% of 265). Serious adverse events were similar between groups (112 43% of 258 patients in the ramucirumab group vs 107 40% of 265 patients in the placebo group). Adverse events related to study treatment and leading to death occurred in eight (3%) patients in the ramucirumab group versus five (2%) patients in the placebo group.
Additional follow-up supports that ramucirumab plus docetaxel significantly improves progression-free survival, without a significant improvement in overall survival, for patients with platinum-refractory advanced urothelial carcinoma. Clinically meaningful benefit might be restricted in an unselected population.
Eli Lilly and Company.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Currently, several therapies are available for metastatic castration-resistant prostate cancer (mCRPC) but no specific clinical factors to personalize treatment. We first sought the prognostic value ...of duration on androgen-deprivation therapy (ADT) for hormone-sensitive prostate cancer (HSPC) in patients receiving androgen-receptor-signaling inhibitors (ARSI) for mCRPC.
A multicenter cohort of mCRPC patients who started ARSI between July 2011 and October 2021 was identified. Based on their initial disease burden and duration on ADT for HSPC, primary progressive (PP) men were classified into four groups: low/intermediate-risk localized disease (LOC) and high-risk localized/locally advanced disease (LAD) and short-term (ST) < 24 vs. long-term (LT) ADT ≥ 24 months, whereas de novo (DN) mHSPC were subdivided into short-time vs. long-time to CRPC.
We included 919 mCRPC patients with a median age of 77 years interquartile range (IQR) = 71-82). Median ADT duration in HSPC was 24 months (IQR = 14-40). Median follow-up was 91 months (IQR = 62-138), median OS and PFS from ARSI start were 20 (IQR 10-32) and 10 months (IQR = 5-19), respectively. In PP developing metastatic disease (n = 655, 71.3%), LOC and LAD with ST ADT had a greater than almost double-risk of death compared to LT ADT (LOC/ST: hazard ratio HR = 2.01; 95% CI 1.54-2.64; LAD/ST: HR = 1.73; 95% CI 1.34-2.24; p < 0.001). In the multivariate analysis including age, prognostic cohort, Gleason, ECOG, radical radiotherapy and prostatectomy, groups with ST ADT were associated with worse OS compared to LT ADT (LOC/ST: HR = 1.84; 95% CI 1.38-2.45; p < 0.001; LAD/ST: HR = 1.59; 95% CI 1.21-2.10; p < 0.001), along with ECOG > 2 (HR = 1.55; 95% CI 1.06-2.26; p = 0.03). There were also similar results of PFS. Moreover, long-time to CRPC in patients with history of DN mHSPC (n = 264, 28.7%) resulted in a better OS/PFS (HR = 0.76, 95% CI 0.56-1.02, p = 0.064 and HR = 0.74, 95% CI 0.55-0.99, p = 0.042, respectively).
Our study showed that duration on ADT for mHSPC was significantly associated with survival in mCRPC undergoing ARSI. These findings suggest a possible connection between initial management of prostate tumour and a better prognostication in mCRPC. Prospective trials are warranted.
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EMUNI, FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, KILJ, KISLJ, MFDPS, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, UKNU, UL, UM, UPUK, VKSCE, ZAGLJ
The complex development of the northern Crotone Basin, a forearc basin of the Calabrian Arc (Southern Italy), has been documented by sedimentological, stratigraphic and structural analyses. This ...Mediterranean‐type fault bounded basin consists of small depocentres commonly characterized by a mix of facies that grades from continental to shallow marine. The lower Pliocene infill of the Crotone Basin consists of offshore marls (Cavalieri Marl) that grade upwards into a shallow‐marine to continental succession up to 850 m thick (Zinga Formation). The succession is subdivided into three main stratal units: Zinga 1, Zinga 2, Zinga 3 bounded by major unconformities. The Zinga 1 stratal unit grades from the Cavalieri Marl to deltaic and shoreface deposits, the latter organized into several stacked progradational wedges that show spectacular thickness changes and progressive unconformities related to salt‐cored NE‐trending growth folds and listric normal faults. The Zinga 2 stratal unit records a progressive and moderate deepening of the area, marked by fluvial sedimentation at the base, followed by lagoonal deposits and by a stacking of mixed bioclastic and siliciclastic shoreface units, organized into metre‐scale high‐frequency cycles. Deposition was controlled by NE‐trending synsedimentary normal faults that dissected the basin into a series of half‐grabens. Hangingwall stratigraphic expansion was compensated by footwall condensed sedimentation. The extensional tectonic regime continued during sedimentation of the Zinga 3 stratal unit. Deposition confined within structural lows during a generalized transgressive phase led to local enhancement of tidal flows and development of sand‐wave trains. The tectonic setting testifies the generalized structural domain of a forearc region. The angular unconformity at the top of the Zinga 3 stratal unit is regional, and marks the activation of a large‐scale tectonic phase linked to strike‐slip movements.
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BFBNIB, FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SBCE, SBMB, UL, UM, UPUK
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