Reported Improvement In Symptoms Research Articles

Missed Opportunities: A Mixed-Methods Assessment of Disparities in Treatment for Fecal Incontinence.

Previous work identified racial disparities in access to fecal incontinence (FI) treatments. However, less is known about patient perspectives of these barriers. This study assessed differences in FI symptom severity and treatment utilization between Black and White patients. This mixed-methods assessment studied adult non-Hispanic Black and White women treated for FI who either did not respond to medical therapy nor received sacral neuromodulation or did not follow up after medical therapy. Structured interviews queried patients about treatments offered and symptom severity. Of the 118 patients in the retrospective evaluation, 59 (50%, 24 Black and 35 White) were interviewed. Black patients were more likely than White patients to report occasional, weekly, or daily solid and stool incontinence (75.0% vs 48.6%, P = 0.042; 87.5% vs 51.4%, P = 0.004, respectively) and flatal incontinence (83.3% vs 62.9%, P = 0.088).Of those prescribed fiber supplements and antidiarrheal medications, Black patients were less likely to report symptom improvement (25.0% vs 70.0%, P = 0.013; 57.1% vs 87.5%, P = 0.092, respectively, for each medication type) and ongoing regimen adherence (25.0% vs 63.3%, P = 0.013; 28.6% vs 87.5%, P = 0.035, respectively).Black patients were more likely to report impairment in daily functioning secondary to FI (83.3% vs 57.1%, P = 0.034) and were more likely to seek a follow-up visit with a health care professional that performs sacral neuromodulation (79.2% vs 28.6%, P < 0.001). Black patients were more likely to have severe symptoms and poorer treatment outcomes and desire future follow-up, highlighting the importance of addressing racial differences in patient preferences in FI management strategies.

Comparing ACDF Outcomes by Cervical Spine Level: A Single Center Retrospective Cohort Study.

Previous research suggests a relationship between complications associated with anterior cervical discectomy and fusion and level involvement; however, there is limited research comparing postoperative outcomes of upper cervical fusions (UCFs) with middle-to-lower cervical fusions (MLCFs). This study aims to compare the outcomes of UCF with MLCF. A retrospective medical record review was conducted on 835 anterior cervical discectomy and fusion patients from 2012 to 2022. Patients were classified as UCF, defined as inclusion of C3 to C4 disc space, or MLCF, defined as lacking C3 to C4 disc space. Demographics were compared using χ 2 or Fisher exact tests. Clinical characteristics were compared in univariable analysis using χ 2 tests, linear-mixed effects models, or generalized linear-mixed models depending on distribution. Significant pre- and intraoperative characteristics were included in multivariable models to minimize confounding. Of the 835 patients included, 562 underwent MLCF and 281 underwent UCF. Median follow-up time was 211 days for UCF and 200 days for MLCF. UCF led to a 1.5-day longer length of stay in both univariable (1.5 vs 3.1, P < 0.0001) and multivariable analysis (2.3 days [95% CI: 1.8, 3.0] vs 3.3 days [2.6, 4.2], P < 0.0001). MLCF patients reported symptom improvement or resolution more often than UCF patients (0.43 [95% CI: 0.30, 0.62] and 0.46 [95% CI: 0.30, 0.70]). Additionally, a significantly higher rate of dysphagia was reported in the UCF group on both univariate and multivariable analysis, respectively (1.72 [95% CI: 1.18, 2.49] and 1.66 [95%CI: 1.08, 2.56]). To our knowledge, this is the first study to investigate the link between cervical fusion level and outcomes. UCF patients demonstrated greater rates of dysphagia, longer length of stay, and lower likelihood of improvement in neurological symptoms postoperatively both before and after controlling for differences in pre- and intraoperative characteristics. This study highlights that UCFs may be associated with worse postoperative outcomes when compared to MLCFs, which can inform surgical decision-making and patient counseling. The study represents Level 3 evidence due to its retrospective design and potential biases, indicating a need for future prospective randomized controlled trials to validate these findings.

Short and longterm outcome of minimally invasive therapy of median arcuate ligament syndrome.

Median arcuate ligament syndrome (MALS) is a rare disorder caused by compression of the celiac artery (CA) by the median arcuate ligament (MAL). Common symptoms include postprandial abdominal pain, diarrhea, and weight loss. While laparoscopic MAL division has long been considered the procedure of choice, robotic-assisted procedures have been increasingly used since their introduction. Aim of this study was to evaluate peri- and postoperative outcomes after minimally invasive MAL release. A retrospective analysis of patients undergoing minimally invasive MAL release at the Department of Surgery, Charité - Universitätsmedizin Berlin, between 2014 and 2023 was performed. 20 patients met the inclusion criteria and underwent either laparoscopic (n = 3) or robotic (n = 17) MAL release. Most common preoperative symptoms were postprandial abdominal pain (90%), weight loss (45%), diarrhea (30%), and nausea (25%). Comparing laparoscopic and robotic surgery, neither the median duration of surgery (minutes: 98 (90-290) vs. 125 (80-254); p = 0.765), the median length of hospital stay (days: 4 (3-4) vs. 5 (3-6); p = 0.179) and intraoperative blood loss (< 50ml in both groups, p = 1.0) showed significant differences. Peak systolic velocity in the CA was significantly reduced postoperatively (cm/s: 320 (200-765) vs. 167 (100-500), p < 0.001). Postoperatively, 17 (85%) patients reported symptom improvement, while 4 (20%) patients had no symptom relief at last follow-up. In 3 cases, follow-up imaging showed evidence of respiratory-related CA stenosis. Despite being complex and challenging procedures, laparoscopic and robotic-assisted MAL release are safe procedures with low risk of postoperative complications and good longterm outcomes.

5103 Synthroid Absorption Conundrum: A Case Deciphered

Abstract Disclosure: H. Nadeem: None. O. Alzohaili: None. Hypothyroidism is a disorder requiring lifelong Synthroid therapy. Untreated patients have high morbidity rate and suffer from weight gain, cold intolerance, fatigue and constipation. Inadequate therapeutic outcomes may result in the case of malabsorption, like GI tract conditions, medication interactions and dietary ingredients. Here, we describe the case of a 50-year-old woman who despite compliance to therapy, had refractory hypothyroidism. Complexity of unexplained Synthroid malabsorption is highlighted, emphasizing the importance of managing and optimizing thyroid hormone replacement therapy. A 50-year-old woman with a history of papillary carcinoma s/p thyroidectomy and radioactive iodine therapy came in with fatigue, weight gain and constipation. Despite taking Synthroid 150 mcg, thyroid function tests (TFTs) remained high with TSH 150 uIU/mL and fT4 0.25 ng/dL. Her dose was gradually increased until it reached 1800 mcg yet repeat TFTs showed refractory hypothyroidism with TSH 179 uIU/mL, fT4 0.8 ng/dL. Compliance was addressed to which she demonstrated strict adherence, while avoiding concurrent intake of food, supplements or medications interfering with the absorption. Autoimmune conditions were ruled out and no dietary patterns affecting absorption were identified. A thyroid absorption test was then performed, during which 2100 mcg of Synthroid were given orally in the AM, and thyroid hormones were measured for 8 hours. She was found to have a TSH in 200s uIU/mL and fT4 &amp;lt;0.10 ng/dL, deeming her to have refractory hypothyroidism. She was seen by GI and had an EGD/ colonoscopy, revealing no abnormalities. In a follow up visit, she was still complaining of the same symptoms, periorbital edema, and mild confusion. Her TSH was still elevated at 225 uIU/mL. She was then started on IV 500 mcg of weekly Synthroid infusions and after several weeks, she reported symptoms improvement. Subsequent TFTs showed a progress in TSH, now 26.6 uIU/mL, with fT4 1 ng/dL, indicating successful management of Synthroid malabsorption. During this process, she had a nutritional assessment and was consistently having hyperlipidemia with LDL 243 mg/dL. She was compliant with Praluent and max dose of atorvastatin 80 mg, but LDL only decreased to 134 mg/dL after adjusting her thyroid hormone levels. With nonadherence being the top cause of medication non responsiveness, ruling out causes of malabsorption is vital. In this case, compliance, nutritional assessment, medication interactions, GI abnormalities, autoimmune conditions were all addressed and no interfering factors were identified. IV treatment with unexplained thyroid hormone malabsorption was the effective treatment, ultimately improving outcomes. With the hope to transition her to oral medication, the possibility of it happening is still not clear. More research is necessary to discover the underlying causes in such an exceptional case. Presentation: 6/2/2024

6983 Pembrolizimab Induced Hypophysitis: Uncommon Side Effect Leading To Late Diagnosis

Abstract Disclosure: T. Chaudhary: None. O. Syed: None. A. Shridar: None. R. Kaur: None. O. Chaudhary: None. M.S. Zubair: None. Background: Pembrolizumab, an immune checkpoint inhibitor, has shown efficacy inducing remission in various malignancies. Associated immune-related adverse effects (irAEs) have been recorded but cases of concomitant hypophysitis and thyroiditis are rare. Clinical case: The patient is a 41-year-old male with a past medical history significant for metastatic melanoma of the left calf, status post sentinel lymph node biopsy and left inguinal lymph node dissection, treated with pembrolizumab for one year. He initially presented with a severe headache that was preceded by two months of fatigue and impaired concentration. CT and MRI head were both unremarkable while lab work was significant for cortisol 0.2 ug/dL and adrenocorticotropic hormone (ACTH) 1.1 pmol/L. A full hormone panel was ordered which showed normal insulin-like growth factor-1 (IGF-1), luteinizing hormone (LH), and follicle-stimulating hormone (FSH). Free testosterone was at the lower end of normal. Prolactin was elevated at 27.3 ng/mL. The thyroid function tests showed primary hypothyroidism with elevated thyroid stimulating hormone (TSH) at 109 uIU/mL, low T4 at 1.5 ug/dL, and low free T4 at 0.4 ng/dL. There were no signs or symptoms of posterior pituitary dysfunction. The patient was diagnosed with hypophysitis and started on hydrocortisone 20 mg once daily along with levothyroxine 175 mcg once daily. DEXA scan showed normal bone mineral density. Subsequently, the patient presented to our care and reported symptom improvement after taking the prescribed medication however he continued to develop fatigue by the end of the day. Therefore, hydrocortisone prescription was switched to 15 mg in the morning and 10 mg at noon. A repeat thyroid function panel, sex hormone binding globulin, and LH were ordered, to be followed up at the patient's next visit. The patient was also advised to wear a medical alert bracelet at all times moving forward. Conclusion: Due to non-specific symptoms at onset, hypophysitis can be undiagnosed or misdiagnosed therefore it is important to have a high clinical suspicion with patients on PD-1 inhibitors presenting with such symptoms. It is also imperative to order a full set of hormones as this patient had concomitant primary hypothyroidism. Presentation: 6/1/2024

Evaluating Decision Regret in Patients Who Have Undergone Sacral Neuromodulation

ObjectivesTo quantify decision regret in individuals who had undergone sacral neuromodulation (SNM). Secondary objectives evaluated for correlation of subjects’ regret score with symptom relief, complications, device explant status, or military deployment status. MethodsEach subject’s decision regret was assessed via a telephone survey utilizing a validated decision regret tool, and regret scores were calculated. A score of 50 was utilized a cutoff, below which patients were deemed to have minimal regret while those scores above 50 were associated with significant decision regret. Comparative statistics were used to identify correlation between regret scores and patient outcomes and military deployment status. ResultsOut of 170 identified subjects, 96 completed the full survey. The mean age of study participants was 49.8 ± 14.5 years, and 58.3% of the participants were female. The average time from implant to survey was 64 months. The mean regret score for patients reporting symptom improvement with the device was 5.4±9.2 (versus 44.1±27.6 for those who did not report symptom improvement, p< 0.001). Regret scores for patients who had device complications were significantly higher than those who did not. At time of survey, 82.3% of subjects had the implant in place. Those subjects who underwent device explant had higher regret scores than those who retained their device. ConclusionsDecision regret related to SNM appeared low. SNM adverse outcome variables (poor symptom improvement, device complications, and explanted device) were associated with significantly higher decision regret scores than those with more ideal outcomes, but overall decision regret was still low. Military deployment had no correlation with SNM regret.

Posterior Cranial Vault Distractor Osteogenesis for the Treatment of Chiari Malformation Type 1: A Systematic Review of the Literature.

Although posterior cranial vault distraction osteogenesis (PVDO) is utilized routinely now for the treatment of craniosynostosis, its use as a treatment option for Chiari type 1 malformation (CM1) is limited to case reports and small retrospective case series. The authors conducted a systematic review of the published literature for PVDO as a treatment for CM1. The primary outcomes were reported complications, symptom improvement, and reoperation rates in patients that had PVDO surgery for CM1. The authors further investigated differences between patients with CM1 with an associated genetic syndrome and craniosynostosis. In total, 42 patients with an average age of 41.1 months were used in our analysis. A total of 38.1% of the patients had a diagnosed syndrome, 78.6% of patients had associated craniosynostosis, and 26/42 (61.9%) total patients-reported symptom improvement. Of 26 patients that reported symptom improvement, 20 (76.9%) had associated syndromes and 6 (23.1%) did not (P=0.011). In addition, of these 26 symptom improved patients, 17 (65.4%) were associated with craniosynostosis while 9 (36.4%) did not have craniosynostosis (P=0.008). Posterior cranial vault distraction osteogenesis seems to be a promising new surgical intervention for treatment of CM1. Most patients saw symptom improvement after treatment (61.9%). There was a clinically and statistically significant difference in symptom improvement for patients with syndromic CM1 when compared with nonsyndromic CM1 patients.

Surgical treatment and outcomes of pectus arcuatum

ObjectivePectus arcuatum is a rare variant of pectus deformities that can cause varying degrees of cardiac compression. A review of the evaluation, surgical repair, and outcomes of pectus arcuatum is presented. MethodsA retrospective review of all patients undergoing surgical treatment of pectus arcuatum at a single institution was conducted between January 1, 2010, and May 31, 2024. Descriptive statistics and surgical techniques are presented. ResultsTwenty patients underwent pectus arcuatum repair (median age, 22.9 years; 55.0% males, median Haller index 2.8 [interquartile range {IQR}, 2.2, 3.6]) during the study period. Preoperatively, all patients were bothered by their chest appearance and symptomatic, with the most common symptoms being exercise intolerance (95.0%), chest pain (90.0%), and shortness of breath (90.0%). Preoperatively, cardiopulmonary exercise testing was performed in almost half the patients with abnormal findings (median maximum oxygen consumption, 67.0% of predicted). A hybrid approach with sternal osteotomy and minimally invasive pectus excavatum repair was utilized in 19 out of 20 cases, with 1 case requiring sternal osteotomy only. Single wedge osteotomy was sufficient in most cases (70.0%). Median intraoperative time was 3.5 hours (IQR, 3.1, 4.2 hours). The adoption of cryoablation in 2018 significantly reduced hospital stays, from 5.0 days (IQR, 4.5, 6.0 days) to 3.0 days (IQR, 2.8, 5.0 days) (P < .001). At follow-up, all reported cosmetic satisfaction and most reported symptom improvement. ConclusionsPectus arcuatum can be successfully repaired with a hybrid surgical approach involving sternal osteotomy and Nuss bar placement. Symptomatic patients should be considered for surgery, with postoperative improvement expected.

Revision Endoscopic Carpal Tunnel Release: An Update on Technique and Outcomes.

Carpal tunnel release is among the most frequently conducted upper extremity procedures. While it typically provides patients with improved sensation, decreased pain, and improved function, a small percentage of cases require revision due to failed initial surgery. Consequently, adoption of endoscopic techniques for carpal tunnel revision procedures is beginning to be explored. A retrospective analysis was conducted of postoperative clinical visits and patient-reported outcome measures for four patients who had undergone five endoscopic revision carpal tunnel release procedures (one patient had bilateral disease). All five cases had symptoms consistent with recurrent carpal tunnel syndrome. One hundred percent (5 of 5) of cases resulted in patients reporting symptom improvement. Postoperative clinical visits and improved patient-reported outcome measures (QuickDash, PROMIS Upper Extremity, VAS Pain, PSEQ, PHQ, and Surgery Satisfaction) scores from baseline to 6 weeks demonstrated successful postoperative function and symptom resolution. Five of five cases resulted in patients resuming normal activities without restrictions within 1-5 weeks, with an average of 3.4 weeks. Preliminary findings suggest the endoscopic revision procedure may be safe and effective for patients with recurrent carpal tunnel syndrome, extending the indications to include scars proximal to the wrist crease. Moreover, this minimally invasive procedure facilitates a transition back to normal activities and avoids incisions on weight-bearing surfaces of the palm. Adopting endoscopic revision may reduce the need for prolonged postoperative care and physical therapy. However, due to the limited sample size of five patients, further investigation with larger cohorts is warranted to confirm these observations.

420. MESH REINFORCEMENT IN HIATAL HERNIA REPAIR: CLINICAL RESULTS OF OUR EARLY EXPERIENCE

Abstract Background Approximately one-third of the population develops diaphragmatic hernias among which only 10% are symptomatic. Restoration of the normal anatomy, hiatus closure and fundoplication are effective methods in the surgical treatment of diaphragmatic hernia repair. Placement of absorbable meshes to cover the hiatal closure emerges as a new, albeit controversial in the literature, technique for reinforcement. This study aims to assess the quality of life of patients diagnosed with hiatal hernia who underwent Nissen or Toupet fundoplication with absorbable biosynthetic mesh placement covering the suturing of the hiatus as an additional step during the laparoscopic or robotic hiatal hernia repair. Methods Data of all patients who underwent Nissen or Toupet fundoplication with absorbable mesh reinforcement at the hiatus between 2020-2023 at our specialised unit was collected and analysed. Thirteen patients who had completed their 6-month and 1-year postoperative follow-up, were interviewed. GERD score, PPI use and postoperative endoscopy were evaluated. Results Occasional use of PPI was reported by one patient, whereas those who had already undergone endoscopy of the upper gastrointestinal tract presented no signs of esophagitis, recurrence of hernia or Barrett esophagus. One patient reported symptom improvement after the operation with a GERD score of 13, while the rest of the patients had a GERD score of 0 (12/13). Conclusion The treatment of diaphragmatic hernias with Nissen or Toupet fundoplication using absorbable mesh reinforcement of the hiatus after closure with sutures seems to be an effective therapeutic method with a success rate over 90% in our case series provided that the rest of the surgical steps are identical between the cases through a well-established technique by our surgical team. However, further studies with larger number of patients and longer follow-up are mandatory aiming to further investigate the potential benefits when mesh reinforcement is applied.

Measuring treatment impacts on symptoms in adults with hypoparathyroidism: findings from the PaTHway trial

BackgroundHypoparathyroidism is a rare endocrine disease frequently associated with serious physical and cognitive symptoms. This study’s purpose was to understand the impacts of the phase 3 PaTHway clinical trial treatment, TransCon PTH, on patients’ overall, physical, and cognitive hypoparathyroidism signs/symptoms and what patients consider meaningful improvement.MethodsIndividual telephone exit interviews were conducted with patients who recently completed the PaTHway trial blinded period. Using a semi-structured interview guide, interviews focused on trial treatment impact on hypoparathyroidism symptoms following the symptom list in the Hypoparathyroidism Patient Experience Scale-Symptom (HPES-Symptom). Meaningful changes in hypoparathyroidism symptoms were assessed with the Patient Global Impression of Severity (PGIS) and Patient Global Impression of Change (PGIC) measures. Interviewees were probed on the meaningfulness of reported changes in symptoms from prior to starting trial treatment to the past 2 weeks/current time. Interviews were audiotaped and transcribed. Transcripts were coded for emerging concepts and themes/subthemes covered in the interview guide based on an adapted grounded theory approach.ResultsNineteen adults with hypoparathyroidism participated in interviews in the United States (n = 13, 68.4%) and Canada (n = 6, 31.6%). Marked improvements in physical and cognitive symptoms were described among trial treatment group respondents. The majority of participants who reported experiencing hypoparathyroidism physical symptoms pre-trial indicated symptom improvement with treatment, including muscle twitching (100%, n = 15), low energy (92.9%, n = 13), feeling tired (92.3%, n = 12), muscle weakness (92.9%, n = 13), tingling without numbness (84.6%, n = 11), trouble sleeping (92.3%, n = 12), muscle cramping (92.3%, n = 12), tingling with numbness (92.3%, n = 12), muscle spasms (100%, n = 12), and pain (90.9%, n = 10). Most participants who reported experiencing cognitive symptoms pre-trial reported symptom improvement with treatment, including difficulty finding the right words (86.7%, n = 13), difficulty concentrating (93.3%, n = 14), trouble remembering (92.9%, n = 13), trouble thinking clearly (85.7%, n = 12), and difficulty understanding information (83.3%, n = 10). Those in the placebo group reported limited or no improvement. The vast majority of participants affirmed that the improvements they experienced in symptom frequency on the PGIS/PGIC and HPES–Symptom were meaningful.ConclusionsFindings indicate that TransCon PTH treatment improved participants’ physical and cognitive hypoparathyroidism symptoms in meaningful ways, while reducing the daily burden associated with conventional therapy.Trial registrationNCT04701203 Registered: 06 January 2021. https://clinicaltrials.gov/study/NCT04701203?term=NCT04701203&rank=1.

Hyperkinetic Biliary Dyskinesia: An Underrecognized Problem With Good Surgical Outcomes After Cholecystectomy.

Introduction While surgical indications for symptomatic cholelithiasis and biliary hypokinesia are clear, hyperkinetic biliary dyskinesia (HBD) is an underrecognized condition with poorly defined symptomology and management guidelines. HBD is typically defined as a gallbladder ejection fraction (EF) ≥ 80% on a hepatobiliary iminodiacetic acid (HIDA) scan. We aimed to identify the prevalence and radiographic reporting of HBD, physician referral patterns, and clinical outcomes following cholecystectomy. Methods A retrospective cohort study of patients with HIDA scans completed over 21 years at our tertiary care hospital was performed. Demographics, symptomatology, referral patterns, and operative data were collected. HBD was defined as HIDA EF ≥80%. Patients with HBD who underwent cholecystectomy were analyzed. ANOVA and chi-square tests were used to compare variables among patients with or without symptom improvement using Statistical Product and Service Solutions (SPSS;IBM SPSS Statistics for Windows, Armonk, NY). Results Of 1,997 patients (73% female, mean age 51.7 years) who had HIDA scans with reported EF, 730 (36.6%) had an EF≥80%. Only 13.7% of HIDA scans with EF≥80% were reported as hyperkinetic, and the rest are "normal". Cholecystectomy was performed in 57 (7.8%) patients with EF≥80%, most being elective (89.5%) and all minimally invasive. Primary care physicians (PCPs) referred most elective cases to surgery (61.4%). The median time from HIDA to cholecystectomy was 146 days. Chronic cholecystitis was common in pathology (82.5%), while 38.6% had cholelithiasis. Overall, 53 patients (93.0%) reported symptom improvement at a median follow-up of 17.0 days. Patients without improvement had a higher prevalence of chronic gastrointestinal conditions (p<0.05), but not significantly more cholelithiasis, cholecystitis, time to surgery, or elective surgery status. Conclusions HBD is common but often underdiagnosed and thus likely underrecognized by treating physicians. Most HBD patients benefit from cholecystectomy, regardless of cholelithiasis. Patients with persistent symptoms after cholecystectomy may have confounding gastrointestinal diagnoses. Increased awareness among radiologists, referring PCPs, gastroenterologists, and surgeons about HBD and postoperative outcomes is needed to ensure that HBD is adequately treated.

Development of a quality of life measure for left ventricular assist device recipients using a mixed methods approach.

Left ventricular assist device (LVAD) recipients report symptom improvement but find adjusting to life with the LVAD challenging. These challenges are unique, and existing patient-reported outcome measures (PROMs) do not reflect their experiences. This study aimed to develop a culturally relevant quality of life PROM for use with LVAD recipients in future research, design evolutions and clinical practice. A three-stage mixed-methods approach was used to develop a PROM: stage 1 included group concept mapping (GCM); stage 2 semi-structured qualitative interviews were conducted with 11 LVAD recipients and 10 clinicians, and a questionnaire was developed using a conceptual framework; and stage 3 used exploratory psychometric analysis of the PROM data using Rasch measurement theory. This paper presents stages 2 and 3. The conceptual framework consisted of four key concepts, including general health, life with the LVAD, equipment and clothing and emotional impact. Statements from interviews and GCM were used to create items for the LVAD quality of life (LVAD-QoL). Cognitive interviews tested face validity and participant comprehension. Forty-nine participants were recruited from three UK transplant centres. PROM data were collected and analysed using Rasch analysis. Four items displayed misfit; dependency between item sets was the biggest issue (57/485 pairwise differences). After restructuring and dealing with item misfit, the LVAD-QoL conformed to the Rasch model, supporting the psychometric properties and quality of the LVAD-QoL. Using a mixed-methods approach ensured the development of a robust and psychometrically sound tool for research, design evolution and clinical practice with LVAD recipients.

Outcomes of transvaginal radiofrequency ablation for symptomatic leiomyomas

ObjectiveDescribe the effect of transvaginal radiofrequency ablation for leiomyoma in symptomatic patients and post procedure follow-up. Material and methodsA retrospective forward-looking observational study was performed including 63 patients who underwent transvaginal radiofrequency ablation between January 2016 and December 2022 at San Cecilio University Hospital in Granada, Spain. The variables registered were: age, parity, the clinical features that lead to the medical visit and pre-surgical treatment. Prior to the procedure, leiomyoma location and volume were determined by transvaginal ultrasound. Follow-ups were scheduled at 6 and 12 months to evaluate symptom improvement, adverse outcomes, leiomyoma volume and if any necessary post-surgical treatment was required. ResultsMean leiomyoma volume at baseline, 6 months and 12 months was 83.3 (24.9–130.7), 42.4 (4.7–89.0) and 19.2 (1.9–80.4) cm3, respectively (p < .001). Significant differences were found between the baseline and 12 month visits (p < .001). At the annual follow-up, the mean rate of volume reduction was 79.5 %, being higher in women who reported symptom improvement compared to those who reported no change in symptom intensity from baseline (84.6% vs. 30.8 %). Patients with a lower initial volume and age over 40 were more likely to have treatment efficacy. 8 pregnancies were registered post procedure. ConclusionRadiofrequency is well tolerated, allowing for same-day discharge, rapid recovery and a safe approach for women who want to preserve their reproductive potential. Initial volume and age over 40 appear to be factors that should be considered in patient selection. Further studies are needed to continue evaluating the outcomes and identifying predictive factors.

Atypical atrial flutter ablation: follow-up and predictors of arrhythmia recurrence

Background: Ablation techniques have evolved greatly with advances in high-density 3D mapping systems over the last few years. Some patients develop atypical atrial flutter (AAFL) after pulmonary vein isolation (PVI). The data regarding follow-up after AAFL ablation as well as predictors of arrhythmia recurrence are lacking. This analysis aims to report procedure success rates and establish predictors of long-term success. Methods and Results: This retrospective cohort study included 45 patients (median age: 69 years; 40% female) who qualified for their first AAFL after PVI. The procedures were performed with the use of conventional ablation-index-guided ThermoCool Smarttouch SF and QDOT MICRO catheters. Freedom from arrhythmia recurrence was used as a primary end point. After 52 weeks of follow-up, 60% of patients suffered from arrhythmia recurrence, but over 70% of the studied cohort reported symptom improvement. In multivariate analysis, class I antiarrhythmics prescription (HR = 0.24 [95% CI 0.06–0.94], p = 0.04) was associated with the lack of arrhythmia recurrence during the follow-up, while cardioversion during procedure was associated with increased risk of arrhythmia recurrence (HR = 7.05 [95% CI 2.09–23.72], p = 0.002). Conclusions: Long-term success of AAFL ablation procedures is not satisfactory despite improvement in symptoms. Class I antiarrhythmics prescription at the discharge contributes to higher chances of sinus rhythm maintenance, whereas cardioversion during the procedure is related to increased risk of arrhythmia recurrence.

Endocrine therapy in advanced high-grade ovarian cancer: real-life data from a multicenter study and a review of the literature.

In women, ovarian cancer is the eighth most frequent cancer in incidence and mortality. It is often diagnosed at advanced stages; relapses are frequent, with a poor prognosis. When platinum resistant, subsequent lines of chemotherapy are of limited effect and often poorly tolerated, leading to quality of life deterioration. Various studies suggest a hormonal role in ovarian carcinogenesis, with a rationale for endocrine therapy in these cancers. This multicenter, retrospective study assessed the use of endocrine treatment for high-grade ovarian epithelial carcinomas treated between 2010 and 2020. Eighty-one patients with ovarian cancers were included. The median duration of platinum sensitivity was 29 months. We observed a 35% disease control rate with endocrine therapy, and 10% reported symptom improvement. For 19 patients (23.5%), the disease was stabilized for more than 6 months. Median overall survival from diagnosis was 62.6 months. Regarding endocrine therapy predictive factors of response, in a multivariate analysis, 3 factors were statistically significant in favoring progression-free survival: platinum sensitivity (P = .021), an R0 surgical resection (P = .020), and the indication for hormone therapy being maintenance therapy (P = .002). This study shows real-life data on endocrine therapy in ovarian cancer. As it is a low-cost treatment with many advantages such as its oral administration and its safety, it may be an option to consider. A perspective lies in the search for cofactors to aim as future therapeutic targets to improve the effectiveness of hormone treatment by means of combination therapy.

Breast Implant Illness as a Clinical Entity: A Systematic Review of the Literature.

Breast implant illness (BII) has become a contentious subject in recent years. While some studies have reported associations between breast implants and autoimmune diseases, others have failed to establish a definitive link. The objective of this study is to provide a comprehensive, up-to-date evaluation of the literature surrounding BII, with an emphasis on identifying patient-related factors that may be associated with BII. A systematic review was performed following PRISMA guidelines using Pubmed (MEDLINE), EMBASE, and Cochrane databases to search for relevant studies published in the last twenty years. Thirty-one studies were included with a total of 39,505 implant patients and mean age of 44.2 ± 9.30 years. Fifteen studies reported implant explantation status with 72.4% patients choosing to remove their implants. Among these, nine studies reported symptom improvement in 83.5% patients. Fifty-three percent of patients undergoing explantation had total capsulectomy. Twenty-eight studies documented total numbers of patients experiencing symptoms related to BII, with 31.3% patients reporting such symptoms. Among these, sixteen studies of 4,109 BII patients distinguished whether the reason for implantation was cosmetic augmentation or reconstruction. When specified, more patients experiencing BII-related symptoms received implants for "cosmetic" versus "reconstructive" reasons (Cosmetic: 3,864/4,109; 94.0% vs. Reconstruction: 245/4,109; 5.96%, p < 0.001). This review provides an overview of the current state of knowledge regarding BII. Our study highlights a potential relationship between BII and indication for implants (cosmetic vs. reconstructive) among other variables, offering valuable insight on factors associated with BII and directions for future research.

Breast Implant Illness (BII) As a Clinical Entity: A Systematic Review of the Literature

Abstract Goals/Purpose Breast implant illness (BII) has become a contentious subject in recent years, raising concerns among both patients and healthcare professionals. While some studies have reported associations between breast implants and autoimmune diseases, others have failed to establish a definitive link. Therefore, the objective of this systematic review is to provide a comprehensive evaluation of the existing literature with a specific emphasis on identifying any symptom or patient patterns to critically evaluate the existence of BII as a distinct entity. Methods/Technique A comprehensive search of relevant published studies up until 2023 was conducted across multiple databases, including PubMed and MEDLINE. A total of 31 studies met inclusion criteria in our analysis. To qualify for inclusion, studies had to focus on breast implant illness and associated systemic symptoms. Two reviewers independently assessed the abstracts, manuscripts, and extracted data from the selected papers. From the included studies, cohort size, reason for implantation, mean age, implant type, implant texture, plane of implant placement, mean follow-up time, implant explantation status, time to implant explantation, symptom resolution after explantation, infections, and complications were extracted. Descriptive statistics was used where appropriate. Results/Complications The mean age of patients was 44.2 ± 9.30 years for all studies included. For studies that included length of time between implant exposure and onset of clinical symptoms (9/31; 29.0%), the mean time from implant or biomaterial exposure to onset of clinical symptoms of BII was 13.4 ± 2.92 years. Fourteen (14/31; 45.2%) studies reported implant explantation status with 60% of the total patient population choosing to remove their implants. Among these, 9 studies reported symptom improvement in 657 patients (83.5%) from a total of 788 patients undergoing implant explantation. Eight studies (8/31; 25.8%) reported whether patients experiencing BII related symptoms were in the cosmetic or reconstructive group. Patients in the cosmetic cohort (899/1005; 89.5%) experienced significantly more BII-related symptoms compared to patients in the reconstructive cohort (213/352; 60.5%) (p &amp;lt; 0.001). Conclusion This systematic review provides a comprehensive overview of the current state of knowledge regarding BII. While the literature offers valuable insights into the potential associations and outcomes related to BII, there are several limitations stemming from heterogeneity in study designs, patient populations, and reporting practices. Our study highlights a relationships between BII and indication for implants (cosmetic vs. reconstructive), infection, and explantation, among other variables, offering valuable directions for future research.

Effect of CYP2D6 genetic variation on patient-reported symptom improvement and side effects among children and adolescents treated with amphetamines.

Amphetamine-based medications are recommended as a first-line pharmacotherapy for the treatment of attention-deficit/hyperactivity disorder in children and adolescents. However, the efficacy and tolerability of these medications vary across individuals, which could be related to interindividual differences in amphetamine metabolism. This study examined if genotype-predicted phenotypes of the cytochrome P450 isozyme CYP2D6 were associated with self-reported side effects and symptom improvement in youth treated with amphetamines. Two hundred fourteen participants aged 6-24 who had a history of past or current amphetamine treatment were enrolled from Western Canada. Amphetamine dose and duration information was collected from the participants along with questions regarding adherence, concomitant medications, symptom improvement and side effects. DNA was extracted from saliva samples and genotyped for CYP2D6 . Binomial logistic regression models were used to determine the effect of CYP2D6 metabolizer phenotype with and without correction for phenoconversion on self-reported symptom improvement and side effects. Genotype-predicted CYP2D6 poor metabolizers had significantly higher odds of reporting symptom improvement when compared to intermediate metabolizers (OR = 3.67, 95% CI = 1.15-11.7, P = 0.029) after correction for phenoconversion and adjusting for sex, age, dose, duration, and adherence. There was no association between CYP2D6 metabolizer phenotype and self-reported side effects. Our findings indicate that phenoconverted and genotype-predicted CYP2D6 poor metabolizer phenotype is significantly associated with higher odds of symptom improvement in children and adolescents treated with amphetamine. If replicated, these results could inform the development of future dosing guidelines for amphetamine treatment in children and adolescents.

Comparison of Healthcare Costs for Women with Treated Versus Untreated Vasomotor Symptoms Due to Menopause.

The study objective was to estimate all-cause healthcare resource utilization (HCRU) and medical and pharmacy costs for women with treated versus untreated vasomotor symptoms (VMS) due to menopause. A retrospective study was conducted using US claims data from Optum Research Database (study period: January 1, 2012-February 29, 2020). Women aged 40-63years with a VMS diagnosis claim and ≥ 12 and ≥ 18months of continuous enrollment during baseline and follow-up periods, respectively, were included. Women treated for VMS were propensity score matched 1:1 to untreated controls with VMS. Standardized differences (SDIFF) ≥ 10% were considered meaningful. A generalized linear model (gamma distribution, log link, robust standard errors) estimated the total cost of care ratio. Subgroup analyses of on- and off-label treatment costs were conducted. Of 117,582 women diagnosed with VMS, 20.5% initiated VMS treatment and 79.5% had no treatment. Treated women (n = 24,057) were matched to untreated VMS controls. There were no differences in HCRU at follow-up (SDIFF < 10%). Pharmacy ($487 vs $320, SDIFF 28.4%) and total ($1803 vs $1536, SDIFF 12.6%) costs were higher in the treated cohort. Total costs were 7% higher in the treated cohort (total cost ratio 1.07, 95% CI 1.05-1.10, P < 0.001). The on-label treatment pharmacy costs ($546 versus $315, SDIFF 38.6%) were higher in the treated cohort. Off-label treatment had higher medical costs ($1393 versus $1201, SDIFF 10.4%). Most women with VMS due to menopause were not treated within 6months following diagnosis. While both on- and off-label treatment increased the total cost of care compared with untreated controls, those increases were modest in magnitude and should not impede treatment for women who report symptom improvement as a result of treatment.