scholarly journals Complications after hysterosalpingography with oil- or water-based contrast: results of a nationwide survey

2020 ◽  
Vol 2020 (1) ◽  
Author(s):  
Inez Roest ◽  
Nienke van Welie ◽  
Velja Mijatovic ◽  
Kim Dreyer ◽  
Marlies Bongers ◽  
...  
Keyword(s):  
The Netherlands ◽  
Antibiotic Prophylaxis ◽  
Contrast Medium ◽  
Conflicts Of Interest ◽  
Unexplained Infertility ◽  
P Value ◽  
Complication Rates ◽  
Research Grants ◽  
Water Based ◽  
Clinical Consequences

Abstract STUDY QUESTION What is the incidence of complications after hysterosalpingography (HSG) using oil-based contrast versus water-based contrast? SUMMARY ANSWER Among 5165 women undergoing HSG, the most frequently reported complication after HSG with oil- and water-based contrast was intravasation of contrast medium (4.8% versus 1.3%, respectively), which was without further consequences, and pulmonary embolization or death did not occur. WHAT IS KNOWN ALREADY An HSG with oil-based contrast increases pregnancy rates in women with unexplained infertility. However, there have been some concerns regarding complications, including the risks of intravasation of the contrast medium, oil embolism and infection. Here, we present the incidence of complications after HSG with different types of contrast media used in the Netherlands in the year 2017. STUDY DESIGN, SIZE, DURATION In January 2018, an electronic survey was sent to all 73 clinics in the Netherlands that perform HSG. The survey consisted of 12 questions addressing the number of HSGs performed in 2017, the amount and type of contrast medium used, the occurrence of post-procedural complications and what their clinical consequences were. Non-responding clinics were sent multiple reminders. PARTICIPANTS/MATERIALS, SETTING, METHODS We calculated the incidence of the complications and reported on their clinical consequences. Furthermore, we examined the average amount of contrast used as well as the administration of prophylactic antibiotics. MAIN RESULTS AND THE ROLE OF CHANCE The response rate was 96% (67/70) (during the study, one site closed and was not included while two clinics no longer performed HSGs). In the 67 clinics, 3289 HSGs with oil-based contrast and 1876 HSGs with water-based contrast were performed in 2017. The median amount of contrast used was 8.0 ml (interquartile range (IQR) 7.0–10.0) for oil-based contrast and 10.0 ml for water-based contrast (IQR 10.0–10.0). Antibiotic prophylaxis was administered in 61% (41/67) of the clinics. Intravasation occurred in 4.8% of the HSGs performed with oil-based contrast and in 1.3% of the HSGs with water-based contrast (relative risk (RR), 3.6; CI, 2.4–5.4). Pulmonary embolism or death was not reported. Pelvic inflammatory disease (PID) occurred in 0.3% of the HSGs performed with oil-based contrast versus 0.4% with water-based contrast. PID occurred in 0.3% of the HSGs in clinics using antibiotic prophylaxis and 0.2% in clinics not using antibiotic prophylaxis. Allergic reactions were reported in one HSG performed with oil-based contrast (0.03%) compared with two HSGs performed with water-based contrast (0.1%). Anaphylactic reactions did not occur. The overall complication rate was 5.1% in the clinics that used oil-based contrast versus 1.8% in the clinics that used water-based contrast (RR, 2.8; CI, 1.9–4.0; P-value, <0.0001). LIMITATIONS, REASONS FOR CAUTION Half of the clinics did not routinely register complications, and the incidence of the complications in their clinic was based on the recall of the clinician. Estimated complication rates in the clinics with and without systematic registration did not significantly differ. The survey asked about the frequency of intravasation but no classification system is being used in daily practice, which may create differences in reporting. There was no standard screening of post-HSG thyroid function for the mother and the foetus. WIDER IMPLICATIONS OF THE FINDINGS In this nationwide cohort study, the complication rates after HSG were low. Intravasation occurred more frequently with the use of oil-based contrast compared with water-based contrast but did not lead to any problems or symptoms in any of the women. We therefore conclude that safety concerns should not be a reason to deny the use of oil-based contrast in women with unexplained infertility. The data also support that fluoroscopy appears to be an essential safety measure during HSG. STUDY FUNDING/COMPETING INTEREST(S) This work was partly funded by Guerbet, France. I.R. reports receiving travel fee for presenting at the Congress of the American Society for Reproductive Medicine 2019 from Guerbet. V.M. reports receiving travel and speaker’s fee as well as research grants from Guerbet. K.D. reports receiving travel and speaker’s fee from Guerbet. B.W.M. is supported by an National Health and Medical Research Council (NHMRC) Practitioner Fellowship (GNT1082548). B.W.M. reports consultancy for ObsEva, Merck KGaA and Guerbet and travel and research grants from Merck KGaA and Guerbet. The other authors do not report conflicts of interest. TRIAL REGISTRATION NUMBER N19.056.

scholarly journals Treatment effect of oil-based contrast is related to experienced pain at HSG: a post-hoc analysis of the randomised H2Oil study

2019 ◽  
Vol 34 (12) ◽  
pp. 2391-2398 ◽  
Author(s):  
N van Welie ◽  
K Dreyer ◽  
J van Rijswijk ◽  
H R Verhoeve ◽  
M Goddijn ◽  
...  
Keyword(s):  
Underlying Mechanism ◽  
Pregnancy Rates ◽  
P Value ◽  
Ongoing Pregnancy ◽  
Research Grants ◽  
Enhancing Effect ◽  
Post Hoc Analysis ◽  
Infertile Women ◽  
Water Based ◽  
Post Hoc

Abstract STUDY QUESTION Does pain or volume of used contrast medium impact the effectiveness of oil-based contrast during hysterosalpingography (HSG)? SUMMARY ANSWER In women who report moderate to severe pain during HSG, the use of oil-based contrast resulted in more ongoing pregnancies compared to the use of water-based contrast, whereas in women who reported mild or no pain, no difference in ongoing pregnancies was found. WHAT IS KNOWN ALREADY We recently showed that in infertile women undergoing HSG, the use of oil-based contrast results in more ongoing pregnancies within 6 months as compared to the use of water-based contrast. However, the underlying mechanism of this fertility-enhancing effect remains unclear. STUDY DESIGN, SIZE, DURATION We performed a post-hoc analysis of the H2Oil study, a multicentre randomised controlled trial (RCT) evaluating the therapeutic effect of oil- and water-based contrast at HSG. Here, we evaluated the impact of pain experienced at HSG and volume of used contrast media during HSG on ongoing pregnancy. PARTICIPANTS/MATERIALS, SETTING, METHODS In a subset of 400 participating women, pain during HSG by means of the Visual Analogue Scale (VAS) (range: 0.0–10.0 cm) was reported, while in 512 women, we registered the volume of used contrast (in millilitres). We used logistic regression analyses to assess whether pain and volume of used contrast media modified the effect of oil-based contrast on ongoing pregnancy rates. Data were analysed according to intention-to-treat principle. MAIN RESULTS AND THE ROLE OF CHANCE In 400 women in whom pain scores were reported, the overall median pain score was 5.0 (Interquartile range (IQR) 3.0–6.8) (oil group (n = 199) 4.8 (IQR 3.0–6.4); water group (n = 201) 5.0 (IQR 3.0–6.7); P-value 0.28). There was a significant interaction between pain (VAS ≤5 versus VAS ≥6) and the primary outcome ongoing pregnancy (P-value 0.047). In women experiencing pain (VAS ≥6), HSG with oil-based contrast resulted in better 6-month ongoing pregnancy rates compared to HSG with water-based contrast (49.4% versus 29.6%; RR 1.7; 95% CI, 1.1–2.5), while in women with a pain score ≤5, 6-month ongoing pregnancy rates were not significantly different between the use of oil- (28.8%) versus water-based contrast (29.2%) (RR 0.99; 95% CI, 0.66–1.5). In the 512 women in whom we recorded contrast, median volume was 9.0 ml (IQR 5.7–15.0) in the oil group versus 8.0 ml (IQR 5.9–13.0) in the water group, respectively (P-value 0.72). Volume of used contrast was not found to modify the effect of oil-based contrast on ongoing pregnancy (P-value for interaction 0.23). LIMITATIONS, REASONS FOR CAUTION This was a post-hoc analysis that should be considered as hypothesis generating. The RCT was restricted to infertile ovulatory women, younger than 39 years of age and with a low risk for tubal pathology. Therefore, our results should not be generalised to infertile women who do not share these features. WIDER IMPLICATIONS OF THE FINDINGS The underlying mechanism of the fertility-enhancing effect induced by HSG with the use of oil-based contrast remains unclear. However, these findings suggest a possible mechanistic pathway, that is increasing intrauterine pressure occurring prior to dislodging pregnancy hindering debris or mucus plugs from the proximal part of otherwise normal fallopian tubes. This information might help in the search of the underlying fertility-enhancing mechanism found by using oil-based contrast during HSG. STUDY FUNDING/COMPETING INTEREST(S) The original H2Oil RCT was an investigator-initiated study that was funded by the two academic institutions (AMC and VUmc) of the Amsterdam UMC. The funders had no role in study design, collection, analysis and interpretation of the data. K.D. reports consultancy for Guerbet. H.V. reports consultancy fees from Ferring. C.B.L. reports speakers’ fees from Ferring and research grants from Ferring, Merck and Guerbet. V.M. reports receiving travel and speakers fees as well as research grants from Guerbet. B.W.M. is supported by an NHMRC Practitioner Fellowship (GNT1082548). B.W.M. reports consultancy for ObsEva, Merck KGaA and Guerbet and travel and research grants from Merck KGaA and Guerbet. The other authors do not report conflict of interests. TRIAL REGISTRATION NUMBER The H2Oil study was registered at the Netherlands Trial Registry (NTR 3270). TRIAL REGISTRATION DATE 1 February 2012. DATE OF FIRST PATIENT’S ENROLMENT 3 February 2012.

scholarly journals Thyroid function in neonates conceived after hysterosalpingography with iodinated contrast

2020 ◽  
Vol 35 (5) ◽  
pp. 1159-1167 ◽  
Author(s):  
N van Welie ◽  
I Roest ◽  
M Portela ◽  
J van Rijswijk ◽  
C Koks ◽  
...  
Keyword(s):  
Contrast Medium ◽  
Thyroid Function ◽  
Medical Center ◽  
Thyroid Function Tests ◽  
Research Grants ◽  
Iodinated Contrast ◽  
Water Based ◽  
Neonatal Thyroid Function ◽  
Maternal Thyroid ◽  
Work Up

Abstract STUDY QUESTION Does exposure to preconceptional hysterosalpingography (HSG) with iodinated oil-based contrast affect neonatal thyroid function as compared to iodinated water-based contrast? SUMMARY ANSWER Preconceptional HSG with iodinated contrast did not influence the neonatal thyroid function. WHAT IS KNOWN ALREADY HSG is a commonly applied tubal patency test during fertility work-up in which either oil- or water-based contrast is used. Oil-based contrast contains more iodine compared to water-based contrast. A previous study in an East Asian population found an increased risk of congenital hypothyroidism (CH) in neonates whose mothers were exposed to high amounts of oil-based contrast during HSG. STUDY DESIGN, SIZE, DURATION This is a retrospective data analysis of the H2Oil study, a randomized controlled trial (RCT) comparing HSG with the use of oil- versus water-based contrast during fertility work-up. After an HSG with oil-based contrast, 214 women had an ongoing pregnancy within 6 months leading to a live birth compared to 155 women after HSG with water-based contrast. PARTICIPANTS/MATERIALS, SETTING, METHODS Of the 369 women who had a live born infant, 208 consented to be approached for future research and 138 provided informed consent to collect data on the thyroid function tests of their offspring (n = 140). Thyroid function tests of these children were retrieved from the Dutch neonatal screening program, which includes the assessment of total thyroxine (T4) in all newborns, followed by thyroid-stimulating hormone only in those with a T4 level of ≤ −0.8 SD score. Furthermore, amount of contrast medium used and time between HSG and conception were compared between the two study groups. MAIN RESULTS AND THE ROLE OF CHANCE Data were collected from 140 neonates conceived after HSG with oil-based (n = 76) or water-based (n = 64) contrast. The median T4 concentration was 87.0 nmol/l [76.0–96.0] in the oil group and 90.0 nmol/l [78.0–106.0] in the water group (P = 0.13). None of the neonates had a positive screening result for CH. The median amount of contrast medium used was 9.0 ml [interquartile range (IQR), 6.0–11.8] in the oil-group and 10.0 ml [IQR, 7.5–14.0] in the water group (P = 0.43). No influence of the amount of contrast on the effect of contrast group on T4 concentrations was found (P-value for interaction, 0.37). LIMITATIONS, REASONS FOR CAUTION A relatively small sample size and possible attrition at follow-up are limitations of this study. Although our results suggest that the use of iodinated contrast media for HSG is safe for the offspring, the impact of a decrease in maternal thyroid function on offspring neurodevelopment could not be excluded, as data on maternal thyroid function after HSG and during conception were lacking. WIDER IMPLICATIONS OF THE FINDINGS As HSG with oil-based contrast does not affect thyroid function of the offspring, there is no reason to withhold this contrast to infertile women undergoing HSG. Future studies should investigate whether HSG with iodinated contrast influences the periconceptional maternal thyroid function and, consequently, offspring neurodevelopment. STUDY FUNDING/COMPETING INTEREST(S) This study received no funding. The original H2Oil RCT was an investigator-initiated study that was funded by the two academic institutions (Academic Medical Center and VU University Medical Center) of the Amsterdam UMC. The funders had no role in study design, collection, analysis and intrepretation of the data. I.R. reports receiving travel fee from Guerbet. C.B.L. reports speakers fee from Ferring in the past and research grants from Ferring, Merck and Guerbet. K.D. reports receiving travel fee and speakers fee from Guerbet. B.W.M. is supported by a NHMRC Practitioner Fellowship (GNT1082548). B.W.M. reports consultancy for ObsEva, Merck KGaA and Guerbet and travel and research grants from Merck KGaA and Guerbet. V.M. reports receiving travel fee and speakers fee as well as research grants from Guerbet. The other authors do not report conflicts of interest. TRIAL REGISTRATION NUMBER Netherlands Trial Register NTR 7526 (Neonates born after the H2Oil study), NTR 3270 (original H2Oil study), www.trialregister.nl

scholarly journals Tubal flushing with oil- or water-based contrast medium: can we identify markers that indicate treatment benefit?

2019 ◽  
Vol 2019 (3) ◽  
Author(s):  
Joukje van Rijswijk ◽  
Nienke van Welie ◽  
Kim Dreyer ◽  
Parvin Tajik ◽  
Cornelis B Lambalk ◽  
...  
Keyword(s):  
Contrast Medium ◽  
Live Birth ◽  
Treatment Effect ◽  
Ongoing Pregnancy ◽  
Research Grants ◽  
Infertile Women ◽  
Semen Volume ◽  
Water Based ◽  
Work Up ◽  
Tubal Pathology

Abstract STUDY QUESTION Can we identify patient characteristics that distinguish which ovulatory infertile women undergoing hysterosalpingography (HSG) benefit more or less from flushing with oil-based contrast medium compared to water-based contrast medium? SUMMARY ANSWER In ovulatory infertile women, HSG with oil-based contrast medium resulted in higher 6-month ongoing pregnancy and live birth rates as compared to HSG with water-based contrast medium and this treatment effect was independent of characteristics of the couple. WHAT IS KNOWN ALREADY We recently showed that in infertile women undergoing HSG, flushing with oil-based contrast medium resulted in more ongoing pregnancies than flushing with water-based contrast medium. STUDY DESIGN, SIZE, DURATION We used data from our randomized clinical trial (RCT) in which 1,119 ovulatory infertile women undergoing HSG during fertility work-up were randomized for use of oil-based (N = 557) or water-based (N = 562) contrast medium. PARTICIPANTS/MATERIALS, SETTING, METHODS We built logistic regression models to predict ongoing pregnancy and live birth (secondary outcome) as a function of the specific contrast, the specific marker, and marker-by-contrast-interaction. Markers considered were female age, maternal ethnicity, female smoking, body mass index (BMI), duration of infertility, infertility being primary or secondary, sperm quality, and previous appendectomy. MAIN RESULTS AND THE ROLE OF CHANCE The 6-month ongoing pregnancy rates in the overall population were 39.7% after use of oil-based contrast versus 29.1% after use of water-based contrast medium [relative risk (RR), 1.37; 95% confidence interval (CI), 1.16–1.61; P < 0.001]. Among the studied baseline characteristics, BMI (P = 0.002) and semen volume (P = 0.02) were statistically significant prognosticators. The treatment effect of oil-based contrast was stronger in women with a BMI ≤30 kg/m2 [RR, 1.54; 95% CI, 1.23–1.92; P = 0.002], and in women whose partner had a semen volume >3 ml [RR, 1.77; 95% CI, 1.28–2.46; P = 0.02]. Also, in women who smoked, the treatment effect of flushing with oil was stronger, but this interaction did not reach statistical significance (P = 0.066). We found no positive effect of oil-based contrast in obese women. We found similar but weaker associations for live birth, which was probably due to lower number of events resulting in less power. LIMITATIONS, REASONS FOR CAUTION The RCT was restricted to infertile ovulatory women younger than 39 years of age without endocrinological disorders and at low risk for tubal pathology. Our results should not be generalized to infertile women who do not share these features. WIDER IMPLICATIONS OF THE FINDINGS All infertile, ovulatory women younger than 39 years with a low risk for tubal pathology will benefit from an HSG with oil-based contrast; therefore, this should be offered to them after fertility work-up. STUDY FUNDING/COMPETING INTEREST(S) The original H2Oil RCT was an investigator-initiated study that was funded by the two academic institutions (AMC and VUmc) of the Amsterdam UMC. The study displayed in this paper was funded by an unconditional research grant from Guerbet. B.W.M. is supported by an NHMRC Practitioner Fellowship (GNT1082548). K.D. reports consultancy for Guerbet, during the conduct of the study, and also reports research grants from Guerbet. C.B.L. reports grants from Guerbet, during the conduct of the study, and grants from Ferring, grants from Merck, and personal fees from Ferring, outside the submitted work. P.H. reports grants from Guerbet, during the conduct of the study, and grants from Ferring and Merck, outside the submitted work. V.M. reports receiving travel and speakers fee as well as research grants from Guerbet. B.W.M. reports consultancy for ObsEva, Merck, Merck KGaA, and Guerbet, and research grants from Guerbet and Merck. The other authors have no conflict of interest to declare. TRIAL REGISTRATION NUMBER NTR 3270 www.trialregister.nl TRIAL REGISTRATION DATE 1 February 2012. DATE OF FIRST PATIENT’S ENROLMENT 3 February 2012.

Complications following local anaesthetic transperineal prostate biopsies without antibiotic prophylaxis: An institution’s experience

2021 ◽  
pp. 205141582098766
Author(s):  
Joseph B John ◽  
Angus MacCormick ◽  
Ruaraidh MacDonagh ◽  
Mark J Speakman ◽  
Ramesh Vennam ◽  
...  
Keyword(s):  
Antibiotic Prophylaxis ◽  
Local Anaesthetic ◽  
Complication Rate ◽  
Admission Rate ◽  
Prophylactic Antibiotics ◽  
Complication Rates ◽  
Level Of Evidence ◽  
Hospital Admission Rate ◽  
Prostate Biopsies ◽  
Disease Characteristics

Objectives: This study aimed to describe a UK institution’s experience with local anaesthetic (LA) transperineal (TP) prostate biopsies (PB), and to report 30-day complications following LATPPB, including a large cohort that did not receive antibiotic prophylaxis. Patients and methods: A prospective database of 313 consecutive patients undergoing LATPPB was maintained, describing patient and disease characteristics, and complications. From September 2019 to January 2020, antibiotic prophylaxis was given before LATPPB ( n=149). Following a change to routine care, from January 2020 to July 2020, prophylactic antibiotics were not given before LATPPB ( n=164). A comparative analysis was performed to determine complication rates following antibiotic prophylaxis discontinuation using electronic hospital and primary care records. Results: Patient and disease characteristics were comparable in antibiotic and non-antibiotic cohorts, and representative of PB and prostate cancer cohorts described in the urological literature. The infection-related complication rate was 0.32% across all patients, and 0% for those not receiving antibiotic prophylaxis. The overall complication rate was 0.64%, and 0.61% for those not receiving antibiotic prophylaxis. There were no severe (Clavien–Dindo 3–5) complications. The unplanned hospital admission rate was 0.64%. Conclusion: The complication rate after LATPPB was low, with no infection-related complications in patients who did not receive antibiotic prophylaxis. This provides further evidence supporting the discontinuation of routine prophylactic antibiotics before TPPB. Level of evidence: Level 2b.

scholarly journals Lateral Ankle Instability Surgical Treatment

2017 ◽  
Vol 2 (3) ◽  
pp. 2473011417S0003
Author(s):  
Bahman Sahranavard ◽  
Cesar de Cesar Netto ◽  
Ashish Shah ◽  
Parke Hudson ◽  
Ibukunoluwa Araoye ◽  
...  
Keyword(s):  
Surgical Treatment ◽  
Revision Surgery ◽  
Surgical Repair ◽  
Ankle Instability ◽  
Primary Repair ◽  
P Value ◽  
Complication Rates ◽  
Suture Anchors ◽  
Lateral Ankle ◽  
Lateral Ankle Instability

Category: Ankle, Sports Introduction/Purpose: Lateral ankle instability is a common cause of disability in the active population. Although the majority of patients can be treated conservatively, surgical repair of the ligaments, with or without reinforcement, represents an excellent option for refractory cases. Failed primary surgical repair, recurrence of the ankle instability and need for revision surgery can rarely happen and is probably affected by multiple variables. That includes patient’s characteristics such as BMI and comorbidities and surgical aspects such as the use of suture anchors and soft-tissue reinforcement. The purpose of this study was to compare patient’s characteristics and complication rates of primary repair and revision procedures. Methods: We retrospectively reviewed 231 patients (160 Female, 71 Male) who underwent surgical treatment for lateral ankle instability between 2010-2016. Thirty-two were revision cases (14.2%), including 24 females and 8 males, and 199 were primary direct repairs (85.8%). The mean age at the time of the surgery was 39 (19-65)years, and average follow-up was 9 (2-55) months. The procedures were performed by four different surgeons. All cases were reviewed based on age, gender, BMI, procedure type and number of incisions, comorbidities, and complications. Data found was compared between the two groups (primary repair and revision surgery) by T-test. A p-value <0.05 was considered significant. Results: The Brostrom-Gould procedure was used in 69.5% of the primary repairs and 63.6% of the revision cases. The use of suture anchors was also similar in both groups (51%). Repair of the calcaneofibular ligament was performed in 68% of primary repairs and 81.8% of the revisions. We didn’t find significant differences regarding comorbidities between two groups: smoking (23.4% x 27.2%, p-value 0.371); diabetes (6.8% x 6%, p-value 0.951) and body mass index above 30 (28.5% x 24.2%, p-value 0.347). We found significant difference in the complication rate of the procedures, with a higher incidence in the revision group (48.4%) when compared to the primary repair group (24%). That included: sural neuritis (15.1% x 3.4%), superficial peroneal neuritis (12.1% x 4.5%), skin problems (9% x 7.4%). Conclusion: Our study of 231 patients that underwent surgical treatment for lateral ankle instability found significant higher incidence of complications in patients who had revision procedures when compared to primary repair. No differences regarding smoking status, diabetes and BMI were found.

scholarly journals Procedural and remote outcome among patients undergoing urgent trans-catheter aortic valve implantation

2020 ◽  
Vol 41 (Supplement_2) ◽  
Author(s):  
A Berkovitch ◽  
A Segev ◽  
A Finkelstein ◽  
R Kornowski ◽  
H Danenberg ◽  
...  
Keyword(s):  
Multivariate Analysis ◽  
Hospital Mortality ◽  
Mortality Rates ◽  
P Value ◽  
Complication Rates ◽  
Increased Risk ◽  
Procedural Complication ◽  
Elective Procedure ◽  
Aortic Valve Implantation ◽  
Valve Implantation

Abstract Background Severe aortic stenosis patients suffer frequent heart failure decompensations events often requiring hospitalization. In extreme situations patients can be found with pulmonary edema and cardiogenic shock, unresponsive to medical treatment. Urgent trans-catheter aortic valve implantation (TAVI) has emerged as a treatment option for these high-risk patients. Methods We investigated 3,599 patients undergoing TAVI. Subjects were divided into two groups based on procedure urgency: patients who were electively hospitalized for the procedure (N=3,448) and those who had an urgent TAVI (N=151). Peri-procedural complications were documented according to the VARC-2 criteria. In hospital and 1-year mortality rates were prospectively documented. Results Mean age of the study population was 82±7, of whom 52% were female. Peri-procedural complication rates was significantly higher among patients with an urgent indication for TAVI compared to those having an elective procedure: valve malposition 3.6% vs. 0.6% (p-value=0.023), valve migration 3.2% vs. 0.9% (p-value=0.016), post procedure myocardial infarction 3.7% vs. 0.3% (p-value=0.004), and stage 3 acute kidney injury 2.6% vs. 0.5%, (p-value=0.02). Univariate analysis found that patients with urgent indication for TAVI had significantly higher in hospital mortality (5.8% vs. 1.4%, p-value&lt;0.001). similarly, multivariate analysis adjusted for age, gender and cardio-vascular risk factors found that patients with urgent indication had more than 5-folds increased risk of in-hospital mortality (OR 5.94, 95% CI 2.28–15.43, p-value&lt;0.001). Kaplan-Meier's survival analysis showed that patients undergoing urgent TAVI had higher 1-year mortality rates compared to patients undergoing an elective TAVI procedure (p-value log-rank&lt;0.001, Figure). Multivariate analysis found they had more than 2-folds increased risk of mortality at 1-year (HR 2.27, 95% CI 1.53–3.38, p&lt;0.001 compared to those having an elective procedure. Conclusions Patients with urgent indication for TAVI have higher in-hospital mortality and higher peri-procedural complication rates. However, if these patients survive the index hospitalization, they enjoy good prognosis. Kaplan-Meier's survival analysis Funding Acknowledgement Type of funding source: None

Toward a predictive theoretical model for osmolality rise with non-humidified incubation: a randomized, multivariate response-surface study

2021 ◽  
Author(s):  
Steven F Mullen
Keyword(s):  
Mathematical Model ◽  
Response Surface ◽  
Surface Area ◽  
Embryo Culture ◽  
Culture Medium ◽  
Conflicts Of Interest ◽  
Volume Ratio ◽  
P Value ◽  
Cook Medical ◽  
Over Time

Abstract STUDY QUESTION What factors associated with embryo culture techniques contribute to the rate of medium osmolality change over time in an embryo culture incubator without added humidity? SUMMARY ANSWER The surface area-to-volume ratio of culture medium (surface area of the medium exposed to an oil overlay), as well as the density and height of the overlaying oil, all interact in a quantitative way to affect the osmolality rise over time. WHAT IS KNOWN ALREADY Factors such as medium volume, different oil types, and associated properties, individually, can affect osmolality change during non-humidified incubation. STUDY DESIGN, SIZE, DURATION Several experimental designs were used, including simple single-factor completely randomized designs, as well as a multi-factor response surface design. Randomization was performed at one or more levels for each experiment. Osmolality measurements were performed over 7 days, with up to 8 independent osmolality measurements performed per treatment group over that time. For the multi-factor study, 107 independent combinations of factor levels were assessed to develop the mathematical model. PARTICIPANTS/MATERIALS, SETTING, METHODS This study was conducted in a research laboratory setting. Commercially available embryo culture medium and oil was used. A MINC incubator without water for humidification was used for the incubation. Osmolality was measured with a vapor pressure osmometer after calibration. Viscometry and density were conducted using a rheometer, and volumetric flasks with an analytical balance, respectively. Data analyses were conducted with several commercially available software programs. MAIN RESULTS AND THE ROLE OF CHANCE Preliminary experiments showed that the surface area-to-volume ratio of the culture medium, oil density, and oil thickness above the medium all contributed significantly (P &lt; 0.05) to the rise in osmolality. A multi-factor experiment showed that a combination of these variables, in the form of a truncated cubic polynomial, was able to predict the rise in osmolality, with these three variables interacting in the model (P &lt; 0.05). Repeatability, as measured by the response of identical treatments performed independently, was high, with osmolality values being ± 2 of the average in most instances. In the final mathematical model, the terms of the equation were significant predictors of the outcome, with all P-values being significant, and only one P-value &gt; 0.0001. LIMITATIONS, REASONS FOR CAUTION Although the range of values for the variables were selected to encompass values that are expected to be encountered in usual embryo culture conditions, variables outside of the range used may not result in accurate model predictions. Although the use of a single incubator type and medium type is not expected to affect the conclusions, that remains an uncertainty. WIDER IMPLICATIONS OF THE FINDINGS Using this predictive model will help to determine if one should be cautious in using a specific system and will provide guidance on how a system may be modified to provide improved stability during embryo culture. STUDY FUNDING/COMPETING INTEREST(S) This study was funded by Cook Medical. The author is a Team Lead and Senior Scientist at Cook Medical. The author has no other conflicts of interest to declare TRIAL REGISTRATION NUMBER N/A.

scholarly journals Randomized Open-Labeled Academic Trial Comparing Standard AZA Therapy with Combination of G-CSF with AZA in High Risk MDS Patients - Interim Analysis

Blood ◽  
2019 ◽  
Vol 134 (Supplement_1) ◽  
pp. 1729-1729
Author(s):  
Anna Jonasova ◽  
Lubomir Minarik ◽  
Vojtech Kulvait ◽  
Michal Pesta ◽  
Adel Schaffartzikova ◽  
...  
Keyword(s):  
Flow Cytometry ◽  
Mixed Model ◽  
Proportional Hazards Model ◽  
Patient Survival ◽  
Conflicts Of Interest ◽  
Cox Proportional Hazards ◽  
Cox Proportional Hazards Model ◽  
P Value ◽  
Pre Treatment ◽  
Time Varying Covariates

Introduction: Myelodysplastic syndrome (MDS) is characterized by differentiation blockade, cytopenias with commontransfusion dependency and immune defects. Upon progression the myeloblasts accumulate and the patients become vulnerable to severe infection complications. Based on the Prague Charles University General Hospital registry (N=164, median age 73), the AZA therapy in higher-risk MDS patients results in median OS 13.8 Mo with ORR 48.5%. We also noted from our retrospective data that AZA-treated patients with higher G-CSF consumption had significantly reduced occurrence of Grade 4 neutropenias and longer OS (19 vs 16 Mo, p value 0.039). Rationale: To improve poor clinical outcomes we initiated a randomized open labeled academic trial that compares standard AZA therapy (A) with novel AZA-based therapy combination involving use of G-CSF added prior AZA (GA). Both AZA and also decitabine were preclinically shown to induce myeloid differentiation upon G-CSF preincubation. G-CSF binds its receptor in granulocytic precursors and neutrophils to stimulate their survival, proliferation, and differentiation via myeloid master regulator transcription factor and leukemia-suppressor PU.1. We also have previously shown that AZA increases PU.1. expression. Study design & Methods: GA/MDS-2013 (EudraCT No 2013-001639-38). Expected for enrollment are 134 patients, currently enrolled 53 patients (GA arm N=29, A arm N=24) with median age 74 years, M:F ratio 32:21 (GA 16:16, A 13:8),median IPSS-R 6, median follow up 11.2 Mo, median cycles of therapy 6. Diagnosis included:MDS (EB1, EB 2) with IPSS int-2/high (75%), MDS/AML<30% MB (22.5%), and CMML II (2.5%). Transplant candidates were excluded. Randomization is 2:1 for GA vs A arm. Primary endpoints: OS, PFS, time to AML transformation, ORR, infections & QoL. Secondary endpoints: biomarkers. Therapy schedule: 75mg/m2 of AZA 5-2-2, in GA: G-CSF s.c. injected 48 hrs before dose 1 and dose 6. G-CSF is measured in patient sera (prior therapy), myeloid surface markers are determined by flow cytometry (day -2, day 1, and day 9 of cycle 1). Genomic libraries from whole bone marrow are prepared by NEBNext Direct Kit involving 33 gene panel, sequencing runs are performed on Illumina platform. Statistics involved longitudinal multivariate data analysis including the joint models for the OS and response. Results: The presented data include 2.5 years since the beginning of the trial. Median survival for GA arm was 11 vs 6 Mo in the A arm. ORR (CR, CRm, PR, HI) was 56% in GA arm vs 33% in the A arm. Transformation to AML for both arms was comparable. The stratified longitudinal Cox proportional hazards model containing time-varying covariates together with the ordinal multilevel logistic mixed model were utilized. From this joint fitted model, a negative coefficient for the G-AZA treatment (significant p-value 0.0442) can be noticed in the case of the Cox Proportional Hazard part of the model. This means that G-AZA treatment improves patient survival. The estimated odds for the GA arm that responded to the therapy with remission rather than progression is 12.4x higher than for the A arm, controlling for the remaining patients' characteristics (p-value 0.0016).Both the GA and A arms are comparably tolerated. Data on serious infections and neutropenia gr4 were not yet available. The levels of G-CSF in sera prior the study in both arms (GA vs A) were comparable. Flow cytometry revealed G-CSF mediated upregulation of FCgRI (CD64) in the GA but not in the A arm. Multivariate analysis indicates the following: mutated genes: DNMT3A (p-value 0.0157), EZH2 (p-value 0.0091), TP53 (borderline p-value 0.0510), & CSF3R (p-value 0.0057) shorten the overall survival. The significant negative effects on response was noted for mutated EZH2 (p-value 0.0208) and CSF3R (p-value 0.0424) genes. Conclusions: The current results supported by different methods and statistics indicates a beneficial effect of G-CSF pre-treatment to standard AZA therapy in higher risk MDS patients. G-CSF pre-treatment to AZA increases OS and ORR. In addition, we identified biomarkers that are negatively associated with patient survival and response including EZH2, DNMT3A, TP53, & CSF3R. Grant Support: Ministry of Health, #16-27790A. Institutional resources: Progres Q49 & Q26, UNCE/MED/016, LQ1604, SVV 260374/2017, RVO-64165. Disclosures No relevant conflicts of interest to declare.

scholarly journals Case-control study of patient characteristics, knowledge of the COVID-19 disease, risk behaviour and mental state in patients visiting an emergency room with COVID-19 symptoms in the Netherlands

PLoS ONE ◽  
2021 ◽  
Vol 16 (4) ◽  
pp. e0249847
Author(s):  
J. P. M. van der Valk ◽  
F. W. J. Heijboer ◽  
H. van Middendorp ◽  
A. W. M. Evers ◽  
J. C. C. M. in ‘t Veen
Keyword(s):  
The Netherlands ◽  
Emergency Room ◽  
Mental State ◽  
Disease Risk ◽  
Risk Behaviour ◽  
Patient Characteristics ◽  
Control Group ◽  
P Value ◽  
Hygiene Measures ◽  
Pharmaceutical Interventions

Background Coronavirus disease 2019 is a serious respiratory virus pandemic. Patient characteristics, knowledge of the COVID-19 disease, risk behaviour and mental state will differ between individuals. The primary aim of this study was to investigate these variables in patients visiting an emergency department in the Netherlands during the COVID-19 pandemic and to compare the “COVID-19 suspected” (positive and negative tested group) with the “COVID-19 not suspected” (control group) and to compare in the “COVID-19 suspected” group, the positive and negative tested patients. Methods Consecutive adult patients, visiting the emergency room at the Franciscus Gasthuis & Vlietland, Rotterdam, the Netherlands, were asked to fill out questionnaires on the abovementioned items on an iPad. The patients were either “COVID-19 suspected” (positive and negative tested group) or “COVID-19 not suspected” (control group). Results This study included a total of 159 patients, 33 (21%) tested positive, 85 (53%) negative and 41 (26%) were COVID-19 not suspected (control group). All patients in this study were generally aware of transmission risks and virulence and adhered to the non-pharmaceutical interventions. Working as a health care professional was correlated to a higher risk of SARS-Cov-2 infection (p- value 0.04). COVID-19 suspected patients had a significantly higher level of anxiety compared to COVID-19 not suspected patients (p-value < 0.001). The higher the anxiety, the more seriously hygiene measures were followed. The anxiety scores of the patients with (pulmonary) comorbidities were significantly higher than without comorbidities. Conclusion This is one of the first (large) study that investigates and compares patient characteristics, knowledge, behaviour, illness perception, and mental state with respect to COVID-19 of patients visiting the emergency room, subdivided as being suspected of having COVID-19 (positive or negative tested) and a control group not suspected of having COVID-19. All patients in this study were generally aware of transmission risks and virulence and adhered to the non-pharmaceutical interventions. COVID-19 suspected patients and patients with (pulmonary) comorbidities were significantly more anxious. However, there is no mass hysteria regarding COVID-19. The higher the degree of fear, the more carefully hygiene measures were observed. Knowledge about the coping of the population during the COVID-19 pandemic is very important, certainly also in the perspective of a possible second outbreak of COVID-19.

scholarly journals Risk of Complications in Children With Adrenal Insufficiency and Covid-19

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. A721-A721
Author(s):  
Manish Gope Raisingani
Keyword(s):  
Relative Risk ◽  
Mortality Rate ◽  
Adrenal Insufficiency ◽  
Endotracheal Intubation ◽  
Health Care Organizations ◽  
The Body ◽  
P Value ◽  
Complication Rates ◽  
Intubation Rate ◽  
Risk Of Mortality

Abstract Background: Adrenal insufficiency may put a person at higher risk with infections due to a lack of normal stress response by the body. Limited data has been available in pediatric adrenal insufficiency with Covid-19 Methods: We used TriNetX, with a large COVID-19 database, collecting real-time electronic medical records data. We compared children (0-18 years) who were diagnosed with Covid-19 with and without Adrenal insufficiency. This database collected information from 54 health care organizations Results: Mortality rate in children with Covid-19 and Adrenal insufficiency was 2.246% (19/846). Mortality rate in children with Covid-19 without adrenal insufficiency was 0.097 % (244/252211). Relative risk of mortality for children with Covid-19 and Adrenal insufficiency was 23.2 with a p value of &lt; 0.0001. Endotracheal intubation rate in children with Covid-19 and Adrenal insufficiency was 1.418% (12/846). Endotracheal intubation rate in children with Covid-19 without Adrenal insufficiency was 0.065% (165/252211). Relative risk of endotracheal intubation for children with Covid-19 and Adrenal insufficiency was 21.68 with a p value of &lt; 0.0001. Sepsis rate in children with Covid-19 and Adrenal insufficiency was 6.974% (59/846). Sepsis rate in children with Covid-19 without Adrenal insufficiency was 0.274% (691/252211). Relative risk of sepsis for children with Covid-19 and Adrenal insufficiency was 25.45 with a p value of &lt; 0.00001. Conclusion: Mortality rate, endotracheal and sepsis showed increased association in children with Adrenal insufficiency and Covid-19 versus children with Covid-19 and no Adrenal insufficiency. Further studies with larger sample size are needed to study complication rates of Covid-19 and Adrenal insufficiency.

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