The developmental basis for scaling of mammalian tooth size.

When evolution leads to differences in body size, organs generally scale along. A well-known example of the tight relationship between organ and body size is the scaling of mammalian molar teeth. To investigate how teeth scale during development and evolution, we compared molar development from initiation through final size in the mouse and the rat. Whereas the linear dimensions of the rat molars are twice that of the mouse molars, their shapes are largely the same. Here, we focus on the first lower molars that are considered the most reliable dental proxy for size-related patterns due to their low within-species variability. We found that scaling of the molars starts early, and that the rat molar is patterned equally as fast but in a larger size than the mouse molar. Using transcriptomics, we discovered that a known regulator of body size, insulin-like growth factor 1 (Igf1), is more highly expressed in the rat molars compared to the mouse molars. Ex vivo and in vivo mouse models demonstrated that modulation of the IGF pathway reproduces several aspects of the observed scaling process. Furthermore, analysis of IGF1-treated mouse molars and computational modeling indicate that IGF signaling scales teeth by simultaneously enhancing growth and by inhibiting the cusp-patterning program, thereby providing a relatively simple mechanism for scaling teeth during development and evolution. Finally, comparative data from shrews to elephants suggest that this scaling mechanism regulates the minimum tooth size possible, as well as the patterning potential of large teeth.

Predictive Factors for Sustained Pain after (sub)acute Osteoporotic Vertebral Fractures. Combined Results from the VERTOS II and VERTOS IV Trial.

PURPOSE: Osteoporotic vertebral compression fractures are treated conservatively or in selected cases with percutaneous vertebroplasty (PV). The purpose of this retrospective analysis is to determine predictive factors for a high visual analogue scale (VAS) pain score after conservative, sham or PV and is based on previously published randomized trials. METHODS: The VERTOS II compared conservative versus PV, and VERTOS IV compared sham versus PV treatment. The conservative group received pain medication. The sham and PV group received subcutaneous lidocaine/bupivacaine. In addition, the PV group received cementation, which was simulated in the sham group. Nineteen different predictors of high (≥ 5) versus low (< 5) VAS pain score at 12 months were investigated. RESULTS: 20.7% of patients in the PV group demonstrated a VAS ≥ 5 at the 12-month, compared to 40.1% in the conservative or sham group, with a significant difference (χ2(1) = 15.26, p < 0.0001, OR = 2.57, 95% CI = 1.59 to 4.15). In the subgroup analysis, we detected five predictors for the risk of high pain scores (VAS ≥ 5 after 12 months follow-up), namely: female, baseline VAS > 8, long-term baseline pain, mild/severe Genant and new fractures. CONCLUSIONS: Statistically significant more patients had a high pain score at 12 months in the sham and conservative group when compared with the PV group. Five predictors were identified for sustained high local back pain, regardless of the received treatment. Patients with moderate fracture deformity were less likely to have high pain scores at 12 months if they received PV than if they had sham or conservative therapy.

Acute exposure to perfluorooctane sulfonate exacerbates heat-induced oxidative stress in a tropical coral species.

Perfluorooctane sulfonate (PFOS) is among the most commonly per- and poly-fluoroalkyl substances (PFAS) found in environmental samples. Nevertheless, the effect of this legacy persistent organic contaminant has never been investigated on corals to date. Corals are the keystone organisms of coral reef ecosystems and sensitive to rising ocean temperatures, but it is not understood how the combination of elevated temperature and PFOS exposure will affect them. Therefore, the aims of the present study were (1) to evaluate the time-dependent bioconcentration and depuration of PFOS in the scleractinian coral Stylophora pistillata using a range of PFOS exposure concentrations, and (2) to assess the individual and combined effects of PFOS exposure and elevated seawater temperature on key physiological parameters of the corals. Our results show that the coral S. pistillata rapidly bioconcentrates PFOS from the seawater and eliminates it 14 days after ceasing the exposure. We also observed an antagonistic effect between elevated temperature and PFOS exposure. Indeed, a significantly reduced PFOS bioconcentration was observed at high temperature, likely due to a loss of symbionts and a higher removal of mucus compared to ambient temperature. Finally, concentrations of PFOS consistent with ranges observed in surface waters were non-lethal to corals, in the absence of other stressors. However, PFOS increased lipid peroxidation in coral tissue, which is an indicator of oxidative stress and enhanced the thermal stress-induced impairment of coral physiology. This study provides valuable insights into the combined effects of PFOS exposure and ocean warming for coral's physiology. PFOS is usually the most prevalent but not the only PFAS defected in reef waters, and thus it will be also important to monitor PFAS mixture concentrations in the oceans and to study their combined effects on aquatic wildlife.

Quantifying the quadrupolar interaction by 45Sc-NMR spectroscopy of single crystals.

Single crystals of the compound [ [Formula: see text] ]Cl4 ⋅ 2H2O were studied by 45Sc-NMR, with the effect of the quadrupolar coupling interaction on the spectra of the spin-7/2 nucleus analysed in the hierarchical framework of perturbation theory. Orientation-dependent spectra acquired at B0 = 17.6 T showed strong second-order effects due to the comparatively large coupling constant of χ = |14.613 ±â€¯0.006| MHz, with an associated asymmetry parameter of ηQ = 0.540 9 ±â€¯0.000 4. By analysing the splittings of the ±3/2 satellites, which in good approximation are subjected to first-order effects only, the full quadrupolar coupling tensor could be determined. The second-order effects caused by this tensor were calculated according to theoretical predictions for all orientations, and subtracted from both the centres of gravity of the satellites, and the central transitions. This allowed extraction of the full chemical shift tensor, with the eigenvalues being δ11 = (5.6 ±â€¯0.9) ppm, δ22 = (12.4 ±â€¯0.9) ppm, and δ33 = (38.5 ±â€¯0.9) ppm. In spectra acquired at a lower magnetic field of B0 = 9.4 T, third-order effects could be detected, and similarly quantified using analytical expressions.

Missing Member in the MII MIII Si4 N7 Compound Class: Carbothermal Reduction and Nitridation Synthesis Reveal Substitution of Nitrogen by Carbon and Oxygen in CaLu[Si4 N7-2x Cx Ox ]:Eu2+ /Ce3+ (x≈0.3).

The nitridosilicate CaLu[Si4 N7-2x Cx Ox ] (x≈0.3) was synthesized by carbothermal reduction and nitridation starting from CaH2 , Lu2 O3 , graphite and amorphous Si3 N4 at 1550 °C in a radiofrequency furnace. CaLu[Si4 N7-2x Cx Ox ] (x≈0.3) crystallizes isotypically to many previously known MII MIII Si4 N7 compounds in the space group P63 mc, as was confirmed by Rietveld refinement based on powder X-ray diffraction data. Incorporation of carbon into the crystal structure as a result of the carbothermal synthesis route was confirmed by 13 C and 29 Si MAS NMR spectroscopy. For the first time in the MII MIII Si4 N7 compound class, complementary EDX measurements suggest that simultaneous incorporation of oxygen compensates for the negative charge excess induced by carbon, resulting in an adjusted sum formula, CaLu[Si4 N7-2x Cx Ox ] (x≈0.3). When excited with UV-to-blue light, CaLu[Si4 N7-2x Cx Ox ] (x≈0.3) shows an emission maximum in the blue spectral region (λem =484 nm; fwhm=4531 cm-1 ) upon doping with Ce3+ , whereas Eu2+ -doped CaLu[Si4 N7-2x Cx Ox ] (x≈0.3) exhibits a yellow-green emission (λem =546 nm; fwhm=3999 cm-1 ).

A Randomized Trial of Intravenous Alteplase before Endovascular Treatment for Stroke.

BACKGROUND: The value of administering intravenous alteplase before endovascular treatment (EVT) for acute ischemic stroke has not been studied extensively, particularly in non-Asian populations. METHODS: We performed an open-label, multicenter, randomized trial in Europe involving patients with stroke who presented directly to a hospital that was capable of providing EVT and who were eligible for intravenous alteplase and EVT. Patients were randomly assigned in a 1:1 ratio to receive EVT alone or intravenous alteplase followed by EVT (the standard of care). The primary end point was functional outcome on the modified Rankin scale (range, 0 [no disability] to 6 [death]) at 90 days. We assessed the superiority of EVT alone over alteplase plus EVT, as well as noninferiority by a margin of 0.8 for the lower boundary of the 95% confidence interval for the odds ratio of the two trial groups. Death from any cause and symptomatic intracerebral hemorrhage were the main safety end points. RESULTS: The analysis included 539 patients. The median score on the modified Rankin scale at 90 days was 3 (interquartile range, 2 to 5) with EVT alone and 2 (interquartile range, 2 to 5) with alteplase plus EVT. The adjusted common odds ratio was 0.84 (95% confidence interval [CI], 0.62 to 1.15; P = 0.28), which showed neither superiority nor noninferiority of EVT alone. Mortality was 20.5% with EVT alone and 15.8% with alteplase plus EVT (adjusted odds ratio, 1.39; 95% CI, 0.84 to 2.30). Symptomatic intracerebral hemorrhage occurred in 5.9% and 5.3% of the patients in the respective groups (adjusted odds ratio, 1.30; 95% CI, 0.60 to 2.81). CONCLUSIONS: In a randomized trial involving European patients, EVT alone was neither superior nor noninferior to intravenous alteplase followed by EVT with regard to disability outcome at 90 days after stroke. The incidence of symptomatic intracerebral hemorrhage was similar in the two groups. (Funded by the Collaboration for New Treatments of Acute Stroke consortium and others; MR CLEAN-NO IV ISRCTN number, ISRCTN80619088.).

Some elements for a history of the dynamical systems theory.

Writing a history of a scientific theory is always difficult because it requires to focus on some key contributors and to "reconstruct" some supposed influences. In the 1970s, a new way of performing science under the name "chaos" emerged, combining the mathematics from the nonlinear dynamical systems theory and numerical simulations. To provide a direct testimony of how contributors can be influenced by other scientists or works, we here collected some writings about the early times of a few contributors to chaos theory. The purpose is to exhibit the diversity in the paths and to bring some elements-which were never published-illustrating the atmosphere of this period. Some peculiarities of chaos theory are also discussed.

Supertetrahedral anions in the phosphidosilicates Na1.25Ba0.875Si3P5 and Na31Ba5Si52P83.

Solid ionic conductors are one key component of all-solid-state batteries, and recent studies with lithium, sodium and potassium phosphidosilicates revealed remarkable ion conduction capabilities in these compounds. We report the synthesis and crystal structures of two quaternary phosphidosilicates with sodium and barium, which crystallize in new structure types. Na1.25Ba0.875Si3P5 contains layers of T3 supertetrahedra, while Na31Ba5Si52P83 forms defect T5 entities and contains Si-Si bonds and P3 trimers. Though T1-relaxometry data indicate a relatively low activation energy for Na+ migration of 0.16 eV, the crystal structures lack sufficient three-dimensional migration paths necessary for fast sodium ion conductvity.

Polymorphism and Fast Potassium-Ion Conduction in the T5 Supertetrahedral Phosphidosilicate KSi2 P3.

The all-solid-state battery (ASSB) is a promising candidate for electrochemical energy storage. In view of the limited availability of lithium, however, alternative systems based on earth-abundant and inexpensive elements are urgently sought. Besides well-studied sodium compounds, potassium-based systems offer the advantage of low cost and a large electrochemical window, but are hardly explored. Here we report the synthesis and crystal structure of K-ion conducting T5 KSi2 P3 inspired by recent discoveries of fast ion conductors in alkaline phosphidosilicates. KSi2 P3 is composed of SiP4 tetrahedra forming interpenetrating networks of large T5 supertetrahedra. The compound passes through a reconstructive phase transition from the known T3 to the new tetragonal T5 polymorph at 1020 °C with enantiotropic displacive phase transitions upon cooling at about 155 °C and 80 °C. The potassium ions are located in large channels between the T5 supertetrahedral networks and show facile movement through the structure. The bulk ionic conductivity is up to 2.6×10-4  S cm-1 at 25 °C with an average activation energy of 0.20 eV. This is remarkably high for a potassium ion conductor at room temperature, and marks KSi2 P3 as the first non-oxide solid potassium ion conductor.

Stentless Root Replacement versus Tissue Valves in Infective Endocarditis - A Propensity-Score Matched Study.

INTRODUCTION: People with aortic/prosthetic valve endocarditis are a high-risk cohort of patients who present a challenge for all medically involved disciplines and who can be treated by various surgical techniques. METHODS: We analyzed the results of treatment of root endocarditis with Medtronic Freestyle® in full-root technique over 19 years (1999-2018) and compared them against treatment with other tissue valves. Comparison was made with propensity score matching, using the nearest neighbor method. Various tests were performed as suited for adequate analyses. RESULTS: Fifty-four patients in the Medtronic Freestyle group (FS group) were matched against 54 complex root endocarditis patients treated with other tissue valves (Tissue group). Hospital mortality was 9/54 (16.7%) in the FS group vs. 14/54 (25.6%) in the Tissue group (P=0.24). Cox regression performed for early results demonstrated coronary heart disease (P=0.004, odds ratio 2.3), among others, influencing early mortality. Recurrent infection was low (1.8% for FS and Tissue patients) and freedom from reoperation was 97.2% at a total of 367 patient-years of follow-up (median of 2.7 years). CONCLUSION: The stentless xenograft is a viable alternative for treatment of valve/root/prosthetic endocarditis, demonstrating a low rate of reinfection. The design of the bioroot allows for complex reconstructive procedures at the outflow tract and the annular level with at an acceptable operative risk. Endocarditis patients can be treated excluding infective tissue from the bloodstream, possibly with benefits, concerning bacteremia and recurrent infection. Furthermore, the use of the stentless bioroot offers varying treatment options in case of future valve degeneration.

Stentless root replacement versus tissue valves in infective endocarditis - a propensity-score matched study

Abstract Introduction: People with aortic/prosthetic valve endocarditis are a high-risk cohort of patients who present a challenge for all medically involved disciplines and who can be treated by various surgical techniques. Methods: We analyzed the results of treatment of root endocarditis with Medtronic Freestyle® in full-root technique over 19 years (1999-2018) and compared them against treatment with other tissue valves. Comparison was made with propensity score matching, using the nearest neighbor method. Various tests were performed as suited for adequate analyses. Results: Fifty-four patients in the Medtronic Freestyle group (FS group) were matched against 54 complex root endocarditis patients treated with other tissue valves (Tissue group). Hospital mortality was 9/54 (16.7%) in the FS group vs. 14/54 (25.6%) in the Tissue group (P=0.24). Cox regression performed for early results demonstrated coronary heart disease (P=0.004, odds ratio 2.3), among others, influencing early mortality. Recurrent infection was low (1.8% for FS and Tissue patients) and freedom from reoperation was 97.2% at a total of 367 patient-years of follow-up (median of 2.7 years). Conclusion: The stentless xenograft is a viable alternative for treatment of valve/root/prosthetic endocarditis, demonstrating a low rate of reinfection. The design of the bioroot allows for complex reconstructive procedures at the outflow tract and the annular level with at an acceptable operative risk. Endocarditis patients can be treated excluding infective tissue from the bloodstream, possibly with benefits, concerning bacteremia and recurrent infection. Furthermore, the use of the stentless bioroot offers varying treatment options in case of future valve degeneration.

Enhanced PeriOperative Care and Health protection programme for the prevention of surgical site infections after elective abdominal surgery (EPOCH): study protocol of a randomised controlled, multicentre, superiority trial.

INTRODUCTION: Surgical site infections (SSI) are a common postoperative complication. During the development of the new WHO guidelines on SSI prevention, also in the Netherlands was concluded that perioperative care could be optimised beyond the current standard practice. We selected a limited set of readily available, cheap and evidence-based interventions from these new guidelines that are not part of standard practice in the Netherlands and formulated an Enhanced PeriOperative Care and Health bundle (EPOCH). Here, we describe the protocol for an open-label, randomised controlled, parallel-group, superiority trial to test the effect of the EPOCH bundle added to (national) standard care in comparison to standard care alone on the incidence of SSI. METHODS AND ANALYSIS: EPOCH consists of intraoperative high fractional inspired oxygen (0.80); goal-directed fluid therapy; active preoperative, intraoperative and postoperative warming; perioperative glucose control and treatment of severe hyperglycaemia (>10 mmoll-1) and standardised surgical site handling. Patients scheduled for elective abdominal surgery with an incision larger than 5 cm are eligible for inclusion. Participants are randomised daily, 1:1 according to variable block sizes, and stratified per participating centre to either EPOCH added to standard care or standard care only. The primary endpoint will be SSI incidence according to the Centers for Disease Control and Prevention (CDC) definition within 30 days as part of routine clinical follow-up. Four additional questionnaires will be sent out over the course of 90 days to capture disability and costs. Other secondary endpoints include anastomotic leakage, incidence of incisional hernia, serious adverse events, hospital readmissions, length of stay and cost effectiveness. Analysis of the primary endpoint will be on an intention-to-treat basis. ETHICS AND DISSEMINATION: Ethics approval is granted by the Amsterdam UMC Medical Ethics Committee (reference 2015_121). Results will be disseminated through peer-reviewed journals and summaries shared with stakeholders. This protocol is published before analysis of the results. TRIAL REGISTRATION NUMBER: Registered in the Dutch Trial Register: NL5572.

Local Electronic Structure in AlN Studied by Single-Crystal 27Al and 14N NMR and DFT Calculations.

Both the chemical shift and quadrupole coupling tensors for 14 N and 27 Al in the wurtzite structure of aluminum nitride have been determined to high precision by single-crystal NMR spectroscopy. A homoepitaxially grown AlN single crystal with known morphology was used, which allowed for optical alignment of the crystal on the goniometer axis. From the analysis of the rotation patterns of 14 N ( I = 1 ) and 27 Al ( I = 5 / 2 ), the quadrupolar coupling constants were determined to χ ( 14 N ) = ( 8 . 19 ± 0 . 02 ) kHz, and χ ( 27 Al ) = ( 1 . 914 ± 0 . 001 ) MHz. The chemical shift parameters obtained from the data fit were δ i s o = - ( 292 . 6 ± 0 . 6 ) ppm and δ Δ = - ( 1 . 9 ± 1 . 1 ) ppm for 14 N, and (after correcting for the second-order quadrupolar shift) δ i s o = ( 113 . 6 ± 0 . 3 ) ppm and δ Δ = ( 12 . 7 ± 0 . 6 ) ppm for 27 Al. DFT calculations of the NMR parameters for non-optimized crystal geometries of AlN generally did not match the experimental values, whereas optimized geometries came close for 27 Al with χ ¯ calc = ( 1 . 791 ± 0 . 003 ) MHz, but not for 14 N with χ ¯ calc = - ( 19 . 5 ± 3 . 3 ) kHz.

Single-crystal 207Pb-NMR of wulfenite, PbMoO4, aided by simultaneous measurement of phosgenite, Pb2Cl2CO3.

The effort for determining NMR interaction tensors from orientation-dependent spectra of single crystals may be greatly reduced by exploiting symmetry relations between atoms of the observed nuclide in the unit cell, as is well documented in the literature. In this work, we determined both the full chemical shift (CS) tensor of 207Pb and the unknown orientation of the rotation axis for the natural mineral phosgenite, Pb2Cl2CO3, from a single rotation pattern, i.e. spectra of crystal orientations from 0 to 180°. In the tetragonal crystal structure of phosgenite, four symmetry-related, but magnetically inequivalent 207Pb are generated by the Wyckoff multiplicity. The mineral wulfenite, PbMoO4, also crystallises in a tetragonal space group, but the site multiplicity for 207Pb generates only one magnetically inequivalent atom, thus not supplying sufficient experimental data to determine CS tensor and axis orientation from an arbitrary number of rotation patterns. One solution to this problem is to simultaneously acquire data of a known compound with high symmetry and Wyckoff multiplicity (here: phosgenite), which supplies additional constraints making the solution of the target compound (here: wulfenite) possible. The 207Pb CS tensors thus determined are characterised by the following eigenvalues in ppm: δ11PAS=(-2553±1), δ22PAS=(-1929±1), δ33PAS=(-1301±1) for phosgenite, and δ11PAS=(-2074±1), δ22PAS=(-2074±1), δ33PAS=(-1898±1) for wulfenite.

Use of the Medtronic Freestyle for aortic valve infection: A retrospective propensity score matched analysis.

BACKGROUNDS: Aortic valve and prosthetic valve endocarditis present a challenging subgroup of patients at high risk. We analyzed our experience using the Medtronic Freestyle in full root technique for the treatment of these cases over 18-year time period. METHODS: We investigated the endocarditis subgroup from our cohort of 971 patients and compared results against other valve types with propensity score matching implementing nearest neighbor method. T-test, χ2 test, logistic regression, and Cox regression were performed. RESULTS: Fifty-four patients from the Freestyle group (FS) were matched against 54 patients from a cohort of 376 aortic valve/root endocarditis patients treated by other valve types (non-FS). Hospital mortality was 9/54 (16.7%) in the FS vs 13/54 (24.1%) in the non-FS group (P = .33). Variables age (P = .003) and renal impairment (P = .026) had an impact on mortality according to Cox regression analysis for early results. Variables with significant risk for long-term mortality included postoperative renal impairment (P = .0001) and multiorgan failure (P = .0001). Recurrent infection was low (1.8% for FS and 3.7% for non-FS group), and freedom from reoperation was 97.2%. Use of the Medtronic Freestyle was no significant risk factor for long-term mortality. CONCLUSION: The Freestyle stentless xenograft is a viable alternative for treatment of valve/root and prosthetic endocarditis. In our experience, it showed good postoperative performance with low rate of reinfection while having an acceptable operative risk-profile for this high-risk cohort.

Infection of Previously Closed Urachus Mimicking Malignancy: A Case Report and Literature Review of Radiological Findings to the Diagnosis.

The urachus is a vestigial structure of the allantois and cloaca. It involutes as fetal development progresses to become a fibrous cord, which courses between the umbilicus and bladder dome within the retropubic space. Infection occasionally occurs in patients with congenital patent urachus. Here, we report a patient with infection of a previously closed urachal tract presenting as an abdominal mass. This has rarely been described in the literature. Current knowledge on imaging findings to the diagnosis is discussed.

Percutaneous Vertebroplasty is no Risk Factor for New Vertebral Fractures and Protects Against Further Height Loss (VERTOS IV).

BACKGROUND: Percutaneous vertebroplasty (PV) is an alternative option to treat pain after an osteoporotic vertebral compression fracture (OVCF). Controversy exists as to whether PV increases the risk of new OVCFs or prevents further vertebral height loss in treated levels. We assessed both during 1-year follow-up in patients with acute OVCF randomised to PV or a sham procedure. METHODS: VERTOS IV is a prospective, multicentre, randomised controlled trial comparing PV with sham therapy in 180 patients. New OVCFs and further vertebral height loss were assessed at 3, 6, and 12 months. RESULTS: After a median follow-up of 12 months (interquartile range (IQR) = 12-12) 31 new fractures were reported in 15 patients from the PV group and 28 new fractures in 19 patients from the sham group. The occurrence of new vertebral fractures did not significantly differ between the groups (χ2(1) = 0.83, p = 0.36, OR = .71, 95%CI = 0.33-1.50). There was no higher fracture risk of adjacent versus distant vertebrae. After sham procedure, further height loss of treated vertebrae occurred more frequently (7 patients (8%) in the PV group and 39 (45%) in the sham group (χ2(1) = 28.85, p < 0.001, OR = 9.84, 95%CI = 4.08-23.73)) and was more severe (p < .001) than after PV. CONCLUSIONS: The risk of further vertebral height loss is significantly lower after PV compared to a sham intervention, i.e. PV protects against progressive vertebral height loss. In addition, PV does not increase the risk of new adjacent and distant OVCFs. LEVEL OF EVIDENCE: Level 1a, therapeutic study. ClinicalTrials.gov number, NCT01200277.

Hospital Results of a Single Center Database for Stentless Xenograft Use in a Full Root Technique in Over 970 Patients.

Our aim was to analyse the hospital outcome for the worldwide largest series of stentless bioroot xenografts (Medtronic Freestyle) as full root replacement in a single centre over a period of 18 years. Retrospective data analysis was performed for the entire cohort of patients undergoing aortic root surgery with the Medtronic Freestyle valve prosthesis. Logistic regression analysis was performed to analyse predictors of in-hospital mortality. 971 patients underwent aortic full root replacement with the Medtronic Freestyle valve in the period from 1999-2017, with an average age of 68.8 ± 10.3y and gender distribution of 608:363 (male:female). Concomitant surgery was performed in 693 patients (71.4%). In-hospital all-comers mortality was 9.8% (95 patients), with the respective highest risk profiles including dissections (6.4%), endocarditis (5.6%) and re-do procedures (12.5%). In-hospital mortality for elective patients was 7.6% while isolated aortic root replacement demonstrated a mortality of 3.6%. Logistic regression analysis demonstrated age (OR 1.05, p = 0.005), dissection (OR 5.78, p < 0.001) and concomitant bypass surgery (OR 2.68, p < 0.001) as preoperative risk factors for the entire cohort. Postoperative analysis demonstrated myocardial infarction (OR 48.6, p < 0.001) and acute kidney injury (OR 20.2, p < 0.001) to be independent risk factors influencing mortality. This analysis presents a work-through of all patients with stentless bioroot treatment without positive selection in a high-volume clinical center with the largest experience world-wide for this form of complex surgery. Isolated aortic root replacement could be performed at acceptable operative risk for this technically-challenging procedure.

Vertebroplasty versus sham procedure for painful acute osteoporotic vertebral compression fractures (VERTOS IV): randomised sham controlled clinical trial.

OBJECTIVE: To assess whether percutaneous vertebroplasty results in more pain relief than a sham procedure in patients with acute osteoporotic compression fractures of the vertebral body. DESIGN: Randomised, double blind, sham controlled clinical trial. SETTING: Four community hospitals in the Netherlands, 2011-15. PARTICIPANTS: 180 participants requiring treatment for acute osteoporotic vertebral compression fractures were randomised to either vertebroplasty (n=91) or a sham procedure (n=89). INTERVENTIONS: Participants received local subcutaneous lidocaine (lignocaine) and bupivacaine at each pedicle. The vertebroplasty group also received cementation, which was simulated in the sham procedure group. MAIN OUTCOME MEASURES: Main outcome measure was mean reduction in visual analogue scale (VAS) scores at one day, one week, and one, three, six, and 12 months. Clinically significant pain relief was defined as a decrease of 1.5 points in VAS scores from baseline. Secondary outcome measures were the differences between groups for changes in the quality of life for osteoporosis and Roland-Morris disability questionnaire scores during 12 months' follow-up. RESULTS: The mean reduction in VAS score was statistically significant in the vertebroplasty and sham procedure groups at all follow-up points after the procedure compared with baseline. The mean difference in VAS scores between groups was 0.20 (95% confidence interval -0.53 to 0.94) at baseline, -0.43 (-1.17 to 0.31) at one day, -0.11 (-0.85 to 0.63) at one week, 0.41 (-0.33 to 1.15) at one month, 0.21 (-0.54 to 0.96) at three months, 0.39 (-0.37 to 1.15) at six months, and 0.45 (-0.37 to 1.24) at 12 months. These changes in VAS scores did not, however, differ statistically significantly between the groups during 12 months' follow-up. The results for secondary outcomes were not statistically significant. Use of analgesics (non-opioids, weak opioids, strong opioids) decreased statistically significantly in both groups at all time points, with no statistically significant differences between groups. Two adverse events occurred in the vertebroplasty group: one respiratory insufficiency and one vasovagal reaction. CONCLUSIONS: Percutaneous vertebroplasty did not result in statistically significantly greater pain relief than a sham procedure during 12 months' follow-up among patients with acute osteoporotic vertebral compression fractures. TRIAL REGISTRATION: ClinicalTrials.gov NCT01200277.