Dexamethasone with Vitamin B12 reduces postoperative pain in lumbar disc herniation patients, reveals study

A recent study published in the Journal of Orthopaedic Surgery and Research found that combining dexamethasone and vitamin B12 (VB12) through epidural injection can significantly improve early postoperative outcomes for patients undergoing percutaneous endoscopic interlaminar discectomy (PEID).

PEID is a minimally invasive procedure used to treat lumbar disc herniation (LDH). While it is generally effective, some patients experience residual pain post-surgery, impacting their recovery and overall quality of life. The study investigated whether supplementing PEID with epidural injections of dexamethasone and VB12 could reduce postoperative pain and improve recovery metrics.

This study enrolled patients who had undergone PEID for LDH and randomly divided them into 2 groups where one was the single surgery (SS) group, which only received PEID and the other was combined treatment (CT) group, which received both the surgery and an epidural injection of dexamethasone and VB12. The evaluation criteria included the Visual Analog Scale (VAS) for pain, the Japanese Orthopaedic Association (JOA) score for functional assessment, and the Oswestry Disability Index (ODI) for measuring disability. Other important metrics included the expression levels of serum inflammatory factors, adverse surgical events, postoperative hospitalization duration, and overall recovery according to the modified MacNab criteria.

The results indicated that patients in the CT group experienced significantly lower VAS scores for low back and leg pain at 1, 3, and 7 days post-surgery when compared to the SS group (P < 0.05). Also, 7 days after surgery, JOA and ODI scores reflected greater improvements in the CT group by underlining improved functional recovery and reduced disability (P < 0.05). Although there were no significant differences at other time points, early postoperative pain management was notably better in the CT group.

Serum analysis revealed that inflammatory markers were lower in the CT group 3 days after surgery by suggesting that the combined treatment played a role in moderating the inflammatory response (P < 0.05). This may contribute to the reported reductions in pain and shorter hospital stays for patients in the CT group (P < 0.05).Both groups had a high rate of positive outcomes, with 89.3% in the SS group and 92.2% in the CT group achieving favorable recovery (P = 0.945) which indicated the overall safety of the combined treatment. Overall, the addition of dexamethasone and VB12 via epidural injection can effectively reduce early postoperative pain, reduce inflammation, and improve initial recovery after PEID.

Reference:

He, C., Li, J., Hu, W., Xiao, B., Fan, T., Zhou, J., Shuang, F., & Li, H. (2024). Effects of dexamethasone combined with vitamin B12 on percutaneous endoscopic interlaminar discectomy early outcomes: a randomized controlled trial. In Journal of Orthopaedic Surgery and Research (Vol. 19, Issue 1). Springer Science and Business Media LLC. https://doi.org/10.1186/s13018-024-05210-z

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Risk of Pulmonary Aspiration During Anesthesia with GLP-1 Agonists, FDA Issues New Safety Warning

Recently the U.S. Food and Drug
Administration (FDA) issued updated safety warnings for all glucagon-like
peptide 1 receptor agonists (GLP-1 RAs) about the risk of pulmonary aspiration
during procedures that require general anesthesia or deep sedation. The updated
news was published in the ‘Drug Safety-related Labeling Changes’ portal of the
U.S.F.D.A website.

The medications whose safety labeling
was updated include semaglutide (Ozempic, Rybelsus, Wegovy); liraglutide
(Saxenda, Victoza); and the dual glucose-dependent insulinotropic polypeptide
(GIP)/GLP-1 tirzepatide (Mounjaro, Zepbound). The updated product labeling
included “Warnings and Precautions,” as a new subsection. This change was done
as there were rare postmarketing reports of pulmonary aspiration among patients
taking GLP-1 RAs who underwent elective surgeries or procedures requiring
general anesthesia or deep sedation.

Also Read: Chemist Body up against Swiggy-PharmEasy’s 10-Minute Medicine Delivery Model, Seeks DCGI Intervention

Despite the patients following
the preoperative fasting guidelines, some of these unfortunate incidents were reported.
There is insufficient data to provide specific recommendations on vindicating
this risk as per the FDA. There is uncertainty on whether adjusting
preoperative fasting protocols or temporarily stopping GLP-1 RA treatment could
reduce the retained gastric contents and the aspiration. Evidence suggests that
GLP-1 RAs may cause delayed gastric emptying, leading to the presence of
residual stomach contents even after recommended fasting periods. This slower
gastric motility increases the risk of complications during anesthesia, as
residual contents can inadvertently enter the lungs (aspiration) when patients
are under deep sedation or anesthesia.

To mitigate the risk of pulmonary
aspiration, patients are now advised to inform their healthcare providers if
they take any GLP-1 RAs before scheduling surgery or anesthesia procedures. In
addition to this, the new warning was also added to the “Adverse Reactions” and
“Postmarketing Experience” sections of the drug labels to recognize pulmonary
aspiration linked to GLP-1 RAs during surgeries requiring anesthesia.

The information in the medication
guide section of the drug labels has also been updated and patients are also instructed
to inform the healthcare providers, especially anesthesiologists and surgeons,
about their use of GLP-1 RAs before undergoing any surgical procedures.

Also Read:11 Formulations declared Not of Standard Quality as per data provided by states: CDSCO Drug Alert

Responsibility has also been
levied on the Healthcare providers to advise and counsel the patient’s risk
associated with GLP-1 RAs. Information about the delaying of stomach emptying, and
risks during surgery or procedures involving anesthesia should be given before
prescribing these medications. So that the patients can in turn inform the healthcare
providers before undergoing any procedures.

This update by the U.S.F.D.A. highlights the
importance of communication between the patients and healthcare providers
keeping in mind the safety of the patients. Despite not having enough evidence
regarding the specific alterations to preoperative fasting or medication
discontinuation protocols this update is a proactive step by FDA concerning the
patient safety considering the widespread use of these drugs for various health
conditions.
Further reading:Drug Safety-related Labeling Changes (SrLC). The U.S.F.D.A, Drug Database.

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Elevated levels of TyG and TyG-obesity composite indices were associated with higher risk for IHD: Study

Sichuan Da Xue Xue Bao Yi Xue BanA study published in the Sichuan Da Xue Xue Bao Yi Xue Ban suggests that elevated levels of TyG and TyG-obesity composite indices were associated with a higher risk for IHD.

A study was done to explore the association between the triglyceride-glucose index (TyG) and TyG-obesity composite indices, including TyG-waist circumference (TyG-WC), TyG-body mass index (TyG-BMI), and TyG-waist-to-height ratio (TyG-WHtR), and the risk of ischemic heart disease (IHD), and to provide reference for the prevention of IHD. The sample of this study was derived from the West China Elderly Preventive and Treatment Merging Cohort, from which 9628 elderly individuals from the retrospective cohort were selected. Cox regression models were used to analyze the association between TyG-related indices and the risk of IHD. Receiver operating characteristic (ROC) curves were plotted to assess and compare the performance of TyG-related indices in predicting the occurrence of IHD. Results: The participants were followed up for a median of 2.82 years, with 7.2% (694/9628) of the participants experiencing IHD events. Multivariate Cox regression showed that after controlling for the covariates, including sex, age, educational attainment, smoking, drinking, exercise, dietary habits, medication history, and whether the participant had hypertension, every time TyG, TyG-WC, TyG-BMI and TyG-WHtR increased by one standard deviation (SD), the risk of IHD increased by 12% (hazard ratio [HR]=1.12, 95% confidence interval [CI]: 1.04-1.20), 21% (HR=1.21, 95% CI: 1.12-1.31), 20% (HR=1.20, 95% CI: 1.12-1.29), and 19% (HR=1.19, 95% CI: 1.10-1.28), respectively. Both the TyG index and TyG-obesity composite indices were positively correlated with IHD risk, showing a linear relationship (P<0.05). TyG-WC (area under the curve[AUC]=0.680, 95% CI: 0.660-0.700, P<0.001), TyG-BMI (AUC=0.674, 95% CI: 0.654-0.695, P<0.001), and TyG-WHtR (AUC=0.678, 95% CI: 0.658-0.698, P<0.001) demonstrated better predictive performance than TyG did (AUC=0.669, 95% CI: 0.648-0.689, P<0.001). Elevated levels of TyG and TyG-obesity composite indices were associated with a higher risk for IHD, and combining TyG with BMI, WC, and WHtR may lead to better performance in risk assessment for IHD than using TyG alone.

Reference:

Yang, Jing, et al. “[Association Between Triglyceride Glucose Index and Triglyceride Glucose-Obesity Composite Indices and the Risk of Ischemic Heart Disease].” Sichuan Da Xue Xue Bao. Yi Xue Ban = Journal of Sichuan University. Medical Science Edition, vol. 55, no. 5, 2024, pp. 1123-1132.

Keywords:

Elevated, levels, TyG, TyG, -obesity, composite, indices, associated, highe, risk, IHD, Study, Yang, Jing, Sichuan Da Xue Xue Bao Yi Xue Ban

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Calcium and oxytocin combo Better for inducing labor in term women with premature rupture of membranes: Study

A study published in the American Journal of Obstetrics & Gynecology MFM suggests that a calcium and oxytocin combo is better for inducing labor in term women with premature membrane rupture.

Intravenous calcium administration has shown promise in enhancing uterine contractions and reducing blood loss during cesarean delivery, but this regimen has not been compared in vaginal labor induction. This study aimed to determine the efficacy of oxytocin combined with calcium vs oxytocin alone for inducing labor in women with term premature rupture of membranes. This single-blind, randomized controlled trial was conducted between October 2022 and May 2023 at a tertiary university hospital. Patients diagnosed with premature rupture of membranes were randomly allocated into 2 groups. The intervention group received a bolus of 10 mL of calcium gluconate followed by a continuous infusion of oxytocin via a pump (n=210), whereas the control group received only oxytocin infusion (n=218). The primary outcome was successful vaginal deliveries within 24 hours after labor induction. The secondary outcomes included the interval from labor induction to delivery, vaginal delivery blood loss, and maternal and neonatal complications. RESULTS: Baseline characteristics, including maternal age, body mass index, and Bishop score before labor induction, were comparable between the groups. The rate of vaginal delivery within 24 hours after labor induction was statistically higher in the intervention group (79.52% vs 70.64%; P=.04). The participants in the intervention group experienced a shortened interval between labor induction and delivery (10.48 vs 11.25 hours; P=.037) and demonstrated a higher success rate in labor induction assessed by the onset of the active phase (93.80% vs 87.61%; P=.04) without increasing the cesarean delivery rate. Reduced hemorrhage was observed in the intervention group (242.5 vs 255.0 mL; P=.0015), and the maternal and neonatal outcomes were comparable between the groups. The coadministration of calcium and oxytocin in labor induction among pregnancies with premature rupture of membranes was more efficient and safer than the administration of oxytocin alone. Our research suggests that the combination therapy of calcium and oxytocin may offer significant advantages during the process of labor induction and result in better outcomes.

Reference:

Ruixiang Cai, Lingyan Chen, Yunguang Xing, Yuguo Deng, Juan Li, Fangfang Guo, Li Liu, Cuihua Xie, Jinying Yang. Oxytocin with calcium vs oxytocin for induction of labor in women with term premature rupture of membranes: a randomized controlled trial. American Journal of Obstetrics & Gynecology MFM, Volume 6, Issue 11, 2024, 101502, ISSN 2589-9333,

https://doi.org/10.1016/j.ajogmf.2024.101502.

(https://www.sciencedirect.com/science/article/pii/S2589933324002283)

Keywords:

Calcium, oxytocin, combo, Better, inducing, labor, term, women, premature, rupture, membranes, study, American Journal of Obstetrics & Gynecology MFM, Ruixiang Cai, Lingyan Chen, Yunguang Xing, Yuguo Deng, Juan Li, Fangfang Guo, Li Liu, Cuihua Xie, Jinying Yang

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Chronic Endometritis associated with Caesarean Scar Diverticulum leading to prolonged menstruation and anemia: Study

Chronic Endometritis associated with Caesarean Scar Diverticulum leading to prolonged menstruation and anemia suggests a study published in the Journal of Reproductive Immunology.

A study was done to investigate the risk factors for Caesarean Scar Diverticulum (CSD) with Chronic Endometritis (CE) and the correlation between CE and clinical symptoms of CSD. The frequency of CE in 44 patients with CSD who underwent surgical treatment and 20 control women who underwent total hysterectomy was assessed and the clinical symptoms in the presence and absence of CE were compared. In accordance with the presence of one or more CD138-positive plasma cells per high-power field, CE was classified as mild or severe group. Results: According to multivariate analysis, the presence of mild CE (OR 8.963, 95 % CI 2.177–36.907, p = 0.002) or severe CE (OR 21.773, 95 % CI 2.285–207.419, p = 0.007) was significantly associated with CSD. Mild CE (OR 12.390, 95 % CI 1.158–132.511, p = 0.037) or severe CE (OR 22.463, 95 % CI 1.657–304.541, P = 0.019) or depth of diverticulum (OR 1.294, 95 % CI 1.003–1.668, p = 0.047) was associated with prolonged menstruation in patients with CSD. The degree of CE in patients with CSD was positively correlated with the days of prolonged menstruation (r = 0.552, p < 0.001) and negatively correlated with haemoglobin level (r = −0.408, p = 0.038). CE was associated with CSD and its clinical symptoms, including prolonged menstruation and decreased haemoglobin. The severity of clinical symptoms of CSD is associated with endometrial inflammation.

Reference:

Junchao Zhang, Jinfa Huang, Zexian Xu, Qian Yang, Lingling Zeng, Lei Zhou, Kaixian Deng,

The correlation between chronic endometritis and Caesarean scar diverticulum. Journal of Reproductive Immunology, Volume 166, 2024, 104324, ISSN 0165-0378,

https://doi.org/10.1016/j.jri.2024.104324.

(https://www.sciencedirect.com/science/article/pii/S0165037824001335)

Keywords:

Chronic, Endometritis, associated, Caesarean, Scar, Diverticulum, leading, prolonged, menstruation, anemia, study , Journal of Reproductive Immunology, Junchao Zhang, Jinfa Huang, Zexian Xu, Qian Yang, Lingling Zeng, Lei Zhou, Kaixian Deng

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Ibuprofen injection exhibits kidney safety with cost benefits over ketorolac: Study

Cumberland Pharmaceuticals announced the publication of a new study demonstrating the safety advantages and cost-saving potential of its Caldolor (ibuprofen) injection when compared to ketorolac in both adult and pediatric patients. The research was published in Frontiers in Pain Research presented real-world outcomes that show Caldolor significantly reduces adverse drug reactions (ADRs) and healthcare resource utilization (HCRU) offered a promising alternative to ketorolac for pain management.

The retrospective analysis of over 17 million patient records compared the outcomes of patients who received either Caldolor or ketorolac. A total of 31,046 adult patients who received Caldolor were matched against 1,24,184 adults who were administered ketorolac. An additional 5,579 pediatric patients were analyzed in separate comparisons. The primary endpoints were the rates of adverse drug reactions and the subsequent healthcare resource utilization which included emergency department visits, inpatient admissions, outpatient visits and medical procedures.

The key findings of the study revealed that in adults, Caldolor was associated with a 45% reduction in renal dysfunction and a 78% decrease in hematuria when compared to ketorolac. These results were statistically significant (p<0.001). Further, fewer gastrointestinal complications and reduced occurrences of common side effects such as headaches, nausea, and abdominal pain were observed in patients using Caldolor. For pediatric patients, Caldolor demonstrated a 51-65% lower rate of ADRs, including a decrease in headaches and nausea, with results supporting clinical significance.

In addition, Caldolor was also linked to a reduction in healthcare costs. The study found that adults and children treated with Caldolor experienced fewer emergency room visits, reduced outpatient consultations and shorter hospital stays when compared to the ones treated with ketorolac. This suggests that Caldolor could contribute to lower overall healthcare expenditures by minimizing complications and the need for additional treatments.

The study confirms the potential of Caldolor to improve patient outcomes while also offering significant cost savings for healthcare systems, added A.J. Kazimi, the CEO of Cumberland Pharmaceuticals. Overall, Caldolor was the first FDA-approved intravenous therapy for fever and is indicated for the treatment of mild to moderate pain, as well as moderate to severe pain in combination with opioid analgesics. It is also used to reduce fever in both adults and pediatric patients.

Source:

Cumberland Pharmaceuticals Inc. (2024, November 5). New Study Compares Caldolor® (ibuprofen injection) to ketorolac. PR Newswire. https://www.prnewswire.com/news-releases/new-study-compares-caldolor-ibuprofen-injection-to-ketorolac-302296908.html

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Multiple penicillin courses may modestly lower risk for Parkinson disease, reveals research

Researchers have reported that early exposure to a few antimicrobials, like penicillins and antifungals, could impact the risk for Parkinson’s disease (PD) in later life. A new study of the Clinical Practice Research Datalink (CPRD) data reported an association where people exposed to higher courses of penicillins had reduced PD risk but those who had multiple antifungal prescriptions had a minor increase in PD risk. The study was conducted by Gian Pal and colleagues and was published in the journal Parkinsonism and Related Disorders.

Parkinson’s disease is a complex neurodegenerative disorder influenced by genetic and environmental factors, but its relationship with prior antimicrobial exposure remains unclear. This study, conducted using a UK-representative population, analyzed whether exposure to different antimicrobials affected the likelihood of developing PD.

The nested case-control study design was carried out with a sample sourced from CPRD. For this study, researchers analyzed data sourced from CPRD for 12,557 cases of PD and controls matched to them, 80,804 controls. Controls and PD cases were matched one to one based on age, sex, and year of diagnosis, the index date. It reviewed prescribed courses of antimicrobials up to 1–5, 6–10, and 11–15 years before diagnosis. Logistic regression models using generalized estimating equations were applied in order to compute ORs and consider false discovery.

  • Those exposed to five or more courses of penicillin 1-5 years before the index date showed a 15% reduction in the odds of developing PD (OR 0.85; 95% CI 0.76–0.95, p = 0.043).

  • A comparable hazard was observed 6–10 years earlier: those who had the same regimen of penicillin had a 16% hazard reduction for PD compared with matched controls (OR 0.84; 95% CI 0.73–0.95, p = 0.059).

  • The association persisted 11–15 years before diagnosis but was not significant (OR 0.87; 95% CI 0.74–1.02, p = 0.291).

  • A small, non-significant reduction in the risk of PD was found to be associated with macrolide treatment courses taken 1–5 years prior to diagnosis (ORs between 0.89–0.91; 95% CI 0.79–0.99, adjusted p = 0.140–0.167).

  • This cohort had an increased risk of PD by 16% (OR 1.16; 95% CI 1.06–1.27, p = 0.020).

Overall, this large analysis speaks to a more subtle relationship between antimicrobial exposure and the risk of PD. Specifically, penicillin exposure may convey slightly lower risk for disease, whereas antifungal exposure slightly increases the risk. Such studies highlight the fact that long-term effects of antimicrobial exposure on neurodegenerative diseases should be considered.

Reference:

Pal, G., Bennett, L., Roy, J., Nyandege, A., Mouradian, M. M., Gerhard, T., & Horton, D. B. (2024). Effects of antimicrobial exposure on the risk of Parkinson’s disease. Parkinsonism & Related Disorders, 127(107081), 107081. https://doi.org/10.1016/j.parkreldis.2024.107081

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Image-guided thermal ablation effective treatment option for patients with papillary thyroid cancer patients: JAMA

Image-guided thermal ablation effective treatment option for patients with papillary thyroid cancer patients suggests a new study published in the JAMA.

Image-guided thermal ablation has been administered for patients with T1N0M0 papillary thyroid carcinoma (PTC) who elect to not undergo surgery or receive active surveillance. Considering the indolent nature of PTC, long-term outcomes of ablation are needed. A study was done to investigate l0-year outcomes of thermal ablation in treating T1N0M0 PTC. This multicenter study was conducted at 4 university-affiliated hospitals in China and included 179 consecutive patients with T1N0M0 PTC (median [IQR] volume, 88.0 [163.2] mm3) who underwent thermal ablation between June 2010 and March 2014. Patients who were ineligible to undergo surgery or elected not to were included, and patients had PTC tumors that were smaller than 20 mm as confirmed by biopsy; no clinical or imaging evidence of extrathyroidal extension, lymph node metastasis (LNM), or distant metastasis; and no history of neck irradiation. The primary outcomes were disease progression (LNM, newly developed tumors, persistent tumors, and distant metastasis) and disease-free survival (DFS). Secondary outcomes were technical success, volume reduction rate, tumor disappearance, complications, and delayed surgery. DFS was calculated using a Kaplan-Meier analysis. Results Among the 179 patients, the mean (SD) age was 45.8 (12.7) years, and 118 (65.9%) were female. During a mean (SD) follow-up period of 120.8 (10.8) months, disease progression was found in 11 of 179 patients (6.1%), including LNM in 4 patients (2.2%), newly developed tumors in 6 patients (3.3%), and persistent tumor in 1 patient (0.6%). The 10-year DFS was 93.9%. The technical success, median volume reduction rate, and tumor disappearance rate was 100%, 100%, and 97.2%, respectively. The magnitude of the disease progression (6.1% vs 7.1%; difference, 1.0%; 95% CI, −6.5% to 25.6%) and DFS (93.9% vs 92.9%; difference, 1.0%, 95% CI, −6.5% to 25.6%) between patients with T1a and T1b tumors was small. The difference in the rate of tumor disappearance between T1a and T1b tumors was large (99.4% vs 71.4%; difference, 28.0%; 95% CI, 10.9%-54.0%). One patient experienced transient voice hoarseness (0.6%). Because of anxiety, 1 patient underwent delayed surgery (0.6%). The results of this 10-year multicenter cohort study suggest that thermal ablation is an effective and safe alternative for patients with T1N0M0 PTC who do not undergo surgery or receive active surveillance. For safe and effective treatment, accurate radiologic evaluation, an understanding of ablation techniques, and experienced physicians are recommended.

Reference:

Yan L, Li Y, Li X, et al. Thermal Ablation for Papillary Thyroid Carcinoma. JAMA Otolaryngol Head Neck Surg. Published online November 07, 2024. doi:10.1001/jamaoto.2024.3229

Keywords:

Image-guided, thermal, ablation, effective, treatment, option, patients, papillary, thyroid, cancer, patients, JAMA , Yan L, Li Y, Li X

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Risk of ovarian cance very low among older women with stable adnexal masses on ultrasound, finds study

The detection of adnexal masses in older patients often raises concerns about ovarian cancer, which poses a common clinical challenge for gynecologists. While surgical evaluation is the only way to immediately rule out cancer, subjecting all patients to surgery would cause excessive harm because the vast majority of these masses are benign. Recent study aimed to assess the ovarian cancer risk among older patients with stable adnexal masses on ultrasound. It was a retrospective cohort study conducted on patients aged 50 years and older with an adnexal mass of less than 10 cm on ultrasound between 2016 and 2020 in a large community-based health system. The masses were considered stable if they did not exhibit an increase of more than 1 cm in the greatest dimension or a change in standardized reported ultrasound characteristics. The study included 4061 patients with stable masses, with an average age of 61 years and an initial mass size of 3.8 cm. Among these patients, 11 cancers were detected, resulting in an absolute risk of 0.27%. The study found that ovarian cancer risk declined with longer duration of stability, with no cancer cases observed after 52 weeks of stability. The risk of ovarian cancer was 0.73 per 1000 person-years at 6 to 12 weeks of stability, 0.63 at 13 to 24 weeks, 0.44 at 25 to 52 weeks, and 0.00 at over 52 weeks. The study suggested that ongoing ultrasound imaging would be needed for 369 patients at 6 to 12 weeks of stability, 410 patients at 13 to 24 weeks, 583 patients at 25 to 52 weeks, and over 1142 patients with stable masses at 53 to 104 weeks to detect one case of ovarian cancer. The authors concluded that the risk of ovarian cancer was very low among older women with stable masses on ultrasound. They recommended that the benefit of ultrasound monitoring beyond 12 months is minimal and may be outweighed by potential risks of repeated imaging.

Discussion

The study found that among patients aged 50 years and older with stable adnexal masses on ultrasound, the risk of ovarian cancer was low and declined with longer demonstrated stability. The researchers suggested that ultrasound monitoring of stable masses beyond 12 months is of minimal benefit and might be associated with potential risks of repeated imaging. These findings indicate that the duration of ultrasound monitoring for stable masses should be limited, considering the minimal benefit and potential risks associated with prolonged surveillance.

Conclusion

In conclusion, the study provides important insights into the ovarian cancer risk among older patients with stable adnexal masses and suggests that prolonged ultrasound monitoring may not be necessary for patients with stable masses. The researchers highlight the importance of considering the potential risks of repeated imaging when determining the optimal duration of ultrasound monitoring for stable adnexal masses.

Key Points

1. The study aimed to assess the ovarian cancer risk among older patients with stable adnexal masses on ultrasound. It was a retrospective cohort study conducted on patients aged 50 years and older with an adnexal mass of less than 10 cm on ultrasound between 2016 and 2020 in a large community-based health system. The masses were considered stable if they did not exhibit an increase of more than 1 cm in the greatest dimension or a change in standardized reported ultrasound characteristics.

2. The study included 4061 patients with stable masses, with an average age of 61 years and an initial mass size of 3.8 cm. Among these patients, 11 cancers were detected, resulting in an absolute risk of 0.27%. The study found that ovarian cancer risk declined with longer duration of stability, with no cancer cases observed after 52 weeks of stability. The risk of ovarian cancer was 0.73 per 1000 person-years at 6 to 12 weeks of stability, 0.63 at 13 to 24 weeks, 0.44 at 25 to 52 weeks, and 0.00 at over 52 weeks.

3. The study suggested that ongoing ultrasound imaging would be needed for 369 patients at 6 to 12 weeks of stability, 410 patients at 13 to 24 weeks, 583 patients at 25 to 52 weeks, and over 1142 patients with stable masses at 53 to 104 weeks to detect one case of ovarian cancer.

4. The authors concluded that the risk of ovarian cancer was very low among older women with stable masses on ultrasound. They recommended that the benefit of ultrasound monitoring beyond 12 months is minimal and may be outweighed by potential risks of repeated imaging.

5. The study found that among patients aged 50 years and older with stable adnexal masses on ultrasound, the risk of ovarian cancer was low and declined with longer demonstrated stability. The researchers suggested that ultrasound monitoring of stable masses beyond 12 months is of minimal benefit and might be associated with potential risks of repeated imaging.

6. In conclusion, the study provides important insights into the ovarian cancer risk among older patients with stable adnexal masses and suggests that prolonged ultrasound monitoring may not be necessary for patients with stable masses. The researchers highlight the importance of considering the potential risks of repeated imaging when determining the optimal duration of ultrasound monitoring for stable adnexal masses.

Reference –

Suh-Burgmann EJ, Hung YY, Schmittdiel JA. Ovarian cancer risk among older patients with stable adnexal masses. Am J Obstet Gynecol 2024;231:440.e1-7.

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Novel Pulmonary Valve Aims to Reduce Invasive Surgeries for Kids, finds study

One of the longstanding challenges of pediatric pulmonary valve replacement is size and the ability to accommodate growth. Young children tend to quickly outgrow fixed size valves-leading to the need for multiple invasive surgeries throughout childhood.

Now, an investigational clinical trial at Children’s Hospital Los Angeles is testing a potential solution to this problem: a novel pulmonary valve that can be size-adjusted as a child grows.

The investigational device, called the Autus Size-Adjustable Valve, is designed to be balloon-expanded-via minimally invasive catheterization procedures-as a child grows. Last year, Children’s Hospital Los Angeles became the first center on the West Coast to offer this trial, which has now expanded to 10 sites around the country.

“Currently, pediatric valvular lesions are essentially a lifelong disease,” says Luke Wiggins, MD, a congenital cardiothoracic surgeon in the Heart Institute at CHLA and the site principal investigator for the study, which also involves Darren Berman, MD. “This new technology has the potential to revolutionize the way we approach and manage these patients.”

How the valve works

The Autus Valve, which is made by Autus Valve Technologies Inc., is a fully synthetic pulmonary valve that is surgically implanted in pediatric patients. Its design mimics the geometry of the human venous valve and features two leaflets.

Because the implant diameter is customizable, surgeons can implant the valve at the size appropriate for the child. The valve is designed to function across a wide range of diameters-from 12.7 to 22 millimeters.

That’s important because while some current pulmonary valves can be balloon-dilated in a catheterization lab to open stenotic leaflets as a child grows, this can often cause the valve to leak.

“One of the unique aspects of the Autus Valve is its two-leaflet design,” Dr. Wiggins explains. “That helps accentuate coaptation of the leaflets. So, when the valve is later balloon-dilated in the Cath lab, it can maintain its competency as a one-way valve.”

Children’s Hospital Los Angeles has been part of the study since its early feasibility phase. The valve is now being studied in a Food and Drug Administration pivotal trial.

The prospective, single-arm, multicenter study plans to enroll 50 patients, ages 18 months to 16 years, who require surgical pulmonary valve replacement. CHLA has so far implanted the device in three patients.

The next frontier

Although the Autus Valve aims to address the major issues of size and growth accommodation in pediatric pulmonary valve replacement, additional challenges remain.

“There is still a lot of opportunity for improvement in pulmonary valve prostheses,” Dr. Wiggins says. “For example, many existing prosthetic heart valves require anti-coagulation, which can cause side effects in children. And many of the biologic valves in use today break down quickly because of kids’ heightened immune responses.

“I see improving these pulmonary valves as the next frontier for our field,” he adds. “This trial is an exciting step toward that future, but there is more ground to cover.”

Dr. Wiggins notes that these trials are only possible because of the multidisciplinary care at the Heart Institute-the largest heart program for children in the Western United States.

“Although the surgical team places the valve, we work very closely with our pediatric cardiologists, our echocardiography and imaging specialists, and our interventional congenital cardiologists in the Catheterization Lab,” he says. “It’s that seamless teamwork that allows us to optimize care for these patients.”

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