High emergency care use during pregnancy associated with increased risk of Severe Maternal Morbidity ,finds study

Pregnant women who frequently seek emergency care during pregnancy may be at a higher risk of experiencing severe maternal morbidity and other negative outcomes. Recent cohort study explored the association between frequent unscheduled care visits during pregnancy Data Source and the risk of severe maternal morbidity (SMM) at the time of birth. The study used data from the Massachusetts Pregnancy to Early Life Longitudinal (PELL) Data System, which links birth and fetal death records to corresponding maternal hospital encounters. The study population included 774,092 pregnant individuals in Massachusetts between October 1, 2002 and March 31, 2020. The key exposure was 4 or more emergency care visits, defined as either an emergency department (ED) visit or observational stay (OS) during pregnancy not resulting in hospital admission. The main outcome was the odds ratio for SMM at the time of birth. Study Results – ContinuedThe results showed that 31.3% of the sample had at least 1 unscheduled visit during pregnancy, and 3.3% had 4 or more visits. High emergency care use was more common among younger individuals, those with Hispanic or non-Hispanic Black race/ethnicity, those with public insurance, and those with a comorbidity or opioid use in the year prior to pregnancy. Study Results – ContinuedIn the multivariable analysis, those with 4 or more unscheduled visits had an adjusted odds ratio of 1.46 (95% CI, 1.29-1.66) for SMM compared to those with 0 visits. Additionally, 43.8% of those with 4 or more unscheduled visits used multiple hospitals during pregnancy. The study concludes that high emergency care use during pregnancy is associated with an increased risk of SMM. Given the fragmentation in care for those with frequent unscheduled visits, the authors suggest that community-based and integrated solutions across health systems may be most beneficial for this high-risk population.

Key Points –

1. The study explored the association between frequent unscheduled care visits during pregnancy and the risk of severe maternal morbidity (SMM) at the time of birth.

2. The study used data from the Massachusetts Pregnancy to Early Life Longitudinal (PELL) Data System, which links birth and fetal death records to corresponding maternal hospital encounters. The study population included 774,092 pregnant individuals in Massachusetts between October 1, 2002 and March 31, 2020.

3. The key exposure was 4 or more emergency care visits, defined as either an emergency department (ED) visit or observational stay (OS) during pregnancy not resulting in hospital admission. The main outcome was the odds ratio for SMM at the time of birth.

4. The results showed that 31.3% of the sample had at least 1 unscheduled visit during pregnancy, and 3.3% had 4 or more visits. High emergency care use was more common among younger individuals, those with Hispanic or non-Hispanic Black race/ethnicity, those with public insurance, and those with a comorbidity or opioid use in the year prior to pregnancy.

5. In the multivariable analysis, those with 4 or more unscheduled visits had an adjusted odds ratio of 1.46 (95% CI, 1.29-1.66) for SMM compared to those with 0 visits. Additionally, 43.8% of those with 4 or more unscheduled visits used multiple hospitals during pregnancy.

6. The study concludes that high emergency care use during pregnancy is associated with an increased risk of SMM, and suggests that community-based and integrated solutions across health systems may be most beneficial for this high-risk population.

Reference –Declercq ER, Liu CL, Cabral HJ, Amutah-Onukagha N, Diop H, Mehta PK. Emergency Care Use During Pregnancy and Severe Maternal Morbidity. JAMA Netw Open. 2024 Oct 1;7(10):e2439939. doi: 10.1001/jamanetworkopen.2024.39939. PMID: 39412800.

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Reducing Toddler Screen Time Before Bed Improves Sleep Quality and Attention: Study

A recent trial in the United Kingdom found that toddler
screen time restriction before bedtime is feasible and has modest sleep
benefits like improved sleep efficiency and fewer night awakenings compared to
the toddlers who were exposed to screen time. The trial results were published
in the journal JAMA Pediatrics.

Sleep is necessary for brain maturation and sleep disturbances
can impact cognitive development in toddlers. Of late toddlers’ exposure to screens
has increased due to various reasons. Exposure to screens before bed can have a
negative impact on the growing child. Research has linked it to abnormal sleep
patterns, concentration issues, attention issues, and development in toddlers. Hence
researchers from the United Kingdom have conducted a study to test the
feasibility of the 7-week parent-administered screen time intervention (PASTI)
in toddlers (aged 16-30 months) who have screen time in the hour before bed and
the impact of PASTI on toddlers’ sleep and attention.

Also Read: Can the Position of Arm During Blood Pressure Screening Overestimate Test Results? Study Explores the Impact

An assessor-blinded, single-site, randomized clinical
trial was conducted between July 2022 and July 2023 by enrolling families with toddlers
aged between 16 and 30 months were included except those with any genetic or
neurological condition or premature birth or participating in any other study.
Toddlers were given 10 minutes or more of screen time in the hour before bed on
3 or more days a week.

Families were randomly divided into 3 groups (1:1:1) where
caregivers removed toddler screen time an hour before bed and used activities
from a bedtime box instead (eg, reading, puzzles). The second group where matched
before-bed activities from the bedtime box were used with no mention of screen
time and those without any interventions.

The feasibility of the trial was
assessed by the participation rate, adherence, retention, family experiences,
and acceptability of the participant families. Efficacy was assessed by screen
use, actigraphy-measured sleep, and eye-tracking attention measures. However, larger trials are needed to confirm the effectiveness of the trial. 


Findings:


  • Out of the 427 families that were screened, 164 were
    eligible (38.4%), and 105 families were randomized.

  • The trial was feasible as 99% of participants retained and
    94% of families adhered to PASTI.

  • PASTI showed reductions in parent-reported screen time, small
    to medium improvements in objectively measured sleep efficiency, night
    awakenings, and reduced daytime sleep but no difference compared with BB only.

  • Regarding attention, PASTI did not show any observable effect
    on the objective measures of attention.

  • When compared to BB PASTI showed a difference in
    parent-reported effortful control and inhibitory control, due to an increase in
    BB-only scores.

Also Read: A Complete Approach: New Recommendations for CVD Risk Management Before, During, and After Non Cardiac Surgery


Thus, the study concluded that removing screen time before
bed is feasible with potential benefits and can be a valuable tool for both
parents and pediatricians.    

Further reading: Pickard H, Chu P, Essex C, et al. Toddler Screen Use Before Bed and Its Effect on Sleep and Attention: A Randomized Clinical Trial. JAMA Pediatr. Published online October 21, 2024. doi:10.1001/jamapediatrics.2024.3997

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FDA approves new oral treatment for uncomplicated UTI in adult women

The US Food and Drug Administration has approved a new oral antibiotic for treatment of uncomplicated urinary tract infections (uUTIs) caused by certain bacteria (Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis) in adult women who have limited or no alternative oral antibacterial treatment options.

Orlynvah is not indicated for the primary or step-down treatment of complicated UTI (cUTI) or complicated intra-abdominal infections (cIAI).

Orlynvah is taken as one oral tablet twice daily for 5 days.

Disease or Condition

An uncomplicated UTI is a bacterial infection of the bladder in women with no structural abnormalities of their urinary tract. Approximately one-half of all women will experience at least one uUTI in their lifetime.

Effectiveness

The effectiveness of Orlynvah was evaluated in two phase 3 controlled, randomized, double blind clinical trials (Trial 1 and Trial 2) which enrolled adult women with uUTI. Orlynvah was administered as one tablet twice daily for 5 days.

Trial 1 (NCT05584657) was a noninferiority trial in which 2214 adult women with uUTI were randomized and treated. Orlynvah demonstrated efficacy in patients with amoxicillin/clavulanate-susceptible pathogens with a composite response rate (combined microbiological response and clinical response) of 62% compared to a composite response rate of 55% in the amoxicillin/clavulanate group. Trial 2 (NCT03354598) was a noninferiority trial in which 1660 adult women with uUTI were randomized and treated. Orlynvah demonstrated efficacy in patients with ciprofloxacin-resistant pathogens with a composite response rate of 48% compared to a composite response rate of 33% in the ciprofloxacin group. Overall, in the two trials combined, 1932 patients were treated with Orlynvah.

Clinical trials evaluating Orlynvah for the treatment of patients with cUTI and cIAI did not demonstrate effectiveness.

Safety Information

The prescribing information includes warnings for hypersensitivity reactions, Clostridioides difficile-Associated Diarrhea (CDAD), and potential exacerbation of gout when given to patients with a known history of gout. Orlynvah is contraindicated in patients with a history of hypersensitivity reactions to the components of Orlynvah (sulopenem etzadroxil and probenecid) or other beta-lactam antibacterial drugs, patients with known blood dyscrasias, patients with known uric acid kidney stones, and patients who are also taking ketorolac tromethamine.

The most common side effects of Orlynvah were diarrhea, nausea, vaginal yeast infection, headache, and vomiting. 

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COVID-19 Linked to Deadly Relapsing Toxic Epidermal Necrolysis: A Case Report

USA: A recent case report published in JAAD Case Reports has highlighted a concerning association between COVID-19 and the incidence of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), two severe dermatologic conditions typically triggered by medications. These conditions can lead to life-threatening skin reactions characterized by widespread erythema, painful blisters, and extensive skin peeling.

Kenneth G. Linden, Department of Dermatology, University of California, Irvine, Irvine, California, and colleagues present a complex case of refractory and relapsing TEN, with no identifiable causative medication, believed to be linked to immune sequelae following COVID-19.

COVID-19 has been linked to an increased incidence of Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), with a reported sevenfold rise during the pandemic. While the exact mechanisms remain unclear, possible pathways include vaccine-induced reactions, virus-induced immune dysregulation, and increased drug hypersensitivity.

In the patient described in the case report, prior vaccination was unlikely the cause, but recent COVID-19 could have led to immune dysregulation and TEN. Notably, drugs like Paxlovid (nirmatrelvir/ritonavir) may contribute to hypersensitivity. Despite various treatments, including IVIG and cyclosporine, the patient’s condition worsened, ultimately resulting in her passing, suggesting COVID-19 might have triggered relapsing TEN.

The case concerns a 48-year-old woman with a history of unicentric Castleman disease, treated six months prior with rituximab, siltuximab, and radiation, and presented with a worsening pruritic rash covering approximately 20% of her body. Four weeks earlier, she had contracted COVID-19 and completed a 5-day course of nirmatrelvir/ritonavir (Paxlovid) three weeks before her hospital visit. On examination, a positive Nikolsky sign was noted, and two biopsies confirmed necrotic keratinocytes, indicating early-stage SJS or toxic epidermal necrolysis.

Her severity-of-illness score indicated a high mortality risk (>90%). The patient was treated with intravenous immunoglobulin (IVIG) and cyclosporine. However, by day three, her condition worsened, showing progression of the rash and oral erosions. A shave biopsy confirmed TEN.

Despite starting prednisone and topical corticosteroids, the patient continued to deteriorate. A second round of IVIG and cyclosporine was initiated, resulting in significant improvement, and she was discharged after 21 days.

However, six days post-discharge, she returned to the emergency department with severe skin pain and sloughing. Extensive testing, including various antibody panels, returned negative results, and a repeat biopsy again indicated TEN.

The patient underwent further rounds of IVIG and cyclosporine but failed to improve. Ultimately, she required intubation due to acute hypoxemic respiratory failure. Tragically, despite intensive care efforts, she passed away a month into her second hospitalization.

“Our case underscores the serious immunocutaneous complications that can arise from COVID-19, highlighting the urgent need for further research to elucidate the disease’s pathophysiology and pave the way for more targeted treatment options,” the researchers concluded.

Reference:

Messele F, Horton L, Sharma AN, Min MS, Rojek NW, Linden KG. Relapsing toxic epidermal necrolysis following COVID-19. JAAD Case Rep. 2024 Jul 31;53:23-26. doi: 10.1016/j.jdcr.2024.07.011. PMID: 39430626; PMCID: PMC11488411.

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Air Pollution Exposure Raises Risk of Death and Graft Failure in Lung Transplant Patients: JAMA

USA: A recent study has highlighted a concerning connection between ambient air pollution and health outcomes in lung transplant patients. Researchers found that higher levels of fine particulate matter (PM2.5) in the air, specifically at the zip code level, were linked to a greater risk of death or graft failure among these vulnerable individuals. The findings underscore the urgent need to address air quality as part of post-transplant care. 

“Living in a zip code with high levels of ambient fine particulate matter was linked to a greater risk of death or graft failure, with adjusted hazard ratios of 1.08 at the previous Environmental Protection Agency standard of 12 μg/m³ and 1.07 at the updated threshold of 9 μg/m³. Additionally, each increase of 1 μg/m³ in exposure at the zip code level raised the hazard by 1%,” the researchers reported in JAMA Network Open.

Lung transplant recipients often face numerous challenges in maintaining their health, and the introduction of external factors such as air pollution can complicate their recovery. PM2.5, tiny particles that can penetrate deep into the lungs and enter the bloodstream, has been known to contribute to several health problems, including respiratory and cardiovascular diseases.

Elevated exposure to ambient PM2.5 air pollution has been linked to adverse health outcomes in various areas, yet its specific effects on lung transplant recipients remain largely unclear. To address this knowledge gap, Olawale Amubieya, University of California, Los Angeles, and colleagues sought to determine whether higher PM2.5 levels in patients’ residential zip codes are associated with increased risks of mortality and graft failure among lung transplant recipients.

For this purpose, the researchers conducted a retrospective cohort study using data from the United Network for Organ Sharing, which includes lung transplant patients from active programs across the U.S. They included adult patients who received lung transplants between May 2005 and December 2016, with follow-up data available until September 10, 2020. The analysis took place from September 2022 to May 2023.

Annual PM2.5 exposure at the zip code level was estimated using established North American data. The primary outcome was the time to death or lung graft failure after the transplant. To assess the relationship between zip code PM2.5 exposure at the time of transplant and the risks of graft failure or mortality, the researchers used a gamma shared frailty Cox proportional hazards model to calculate both unadjusted and adjusted hazard ratios.

Based on the study, the researchers reported the following findings:

  • Among 18,265 lung transplant recipients, with an average age of 55.3 years and 40.2% being female, 9.8% lived in areas where the annual PM2.5 exposure met or exceeded the Environmental Protection Agency (EPA) standard of 12 μg/m³. The remaining 90.2% lived in areas with lower levels.
  • In unadjusted analysis, the median graft survival was 4.87 years for those in high PM2.5 areas and 5.84 years for those in low PM2.5 areas.
  • Living in areas with PM2.5 levels at or above the EPA standard was linked to a higher risk of death or graft failure, with an unadjusted hazard ratio of 1.11.
  • After adjusting for other factors, the hazard ratio remained significant at 1.08.
  • Each increase of 1 μg/m³ in PM2.5 exposure was associated with a slightly higher risk of death or graft failure, with an adjusted hazard ratio of 1.01.

The study found that higher levels of ambient PM2.5 exposure at the zip code level were linked to an increased risk of death or graft failure in lung transplant recipients.

“Further research is necessary to explore this relationship more deeply, which could inform strategies for reducing risks both for individuals and across populations,” the researchers concluded.

Reference:

Amubieya O, Weigt S, Shino MY, et al. Ambient Air Pollution Exposure and Outcomes in Patients Receiving Lung Transplant. JAMA Netw Open. 2024;7(10):e2437148. doi:10.1001/jamanetworkopen.2024.37148

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Cannabis use during pregnancy impacts thinking, learning skills, may increase aggression among children: JAMA

As cannabis is legalized and is more accessible in various forms across the country, there is increasing concern among health care providers about potential impact on children. Researchers at Nationwide Children’s Hospital have new findings to add to the existing evidence that cannabis exposure before birth can negatively impact children.

In a study published today in JAMA Pediatrics, researchers found prenatal cannabis exposure was associated in early childhood with poorer thinking skills and behaviors such as impulse control, paying attention, planning ability, and more aggressive behavior, all of which play a vital role in how children perform in school and interact with others.

“Although cannabis is a natural product, there are still many risks to using it during pregnancy,” said Sarah Keim, PhD, principal investigator in the Center for Biobehavioral Health at Nationwide Children’s, and lead author of the study. “Some women may turn to cannabis to help deal with some common issues of pregnancy including nausea, sleep problems and stress. This is not recommended. Consulting with a health care provider to find safer options to help with these issues during pregnancy is important.”

Researchers used multiple assessments, including asking parents about their child’s typical behaviors and measurement of skills related to impulse control, paying attention, solving problems, and managing emotions in preschool-aged children. Results showed children exposed to cannabis had more difficulty controlling their impulses, paying attention and planning, and showed more aggressive behavior when researchers observed their behavior in a play laboratory environment.

“Our findings were not surprising – they actually confirm and expand on longstanding evidence from previous research,” said Dr. Keim. “With our more contemporary and diverse sample of women and children, and with much higher potency of cannabis now than in past decades, this study validates previous research and supports existing clinical recommendations for patients.”

The American Academy of Pediatrics and the American College of Obstetricians and Gynecologists both caution against cannabis use during pregnancy because of possible health risks to mothers and children.

Reference:

Keim SA, Fried P, Yeates KO, et al. Prenatal Cannabis Exposure and Executive Function and Aggressive Behavior at Age 5 Years. JAMA Pediatr. Published online October 28, 2024. doi:10.1001/jamapediatrics.2024.4352.

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individuals with Vitiligo have elevated Cardiovascular Risk, reveals research

A new study found that vitiligo is associated with a significant
risk of cardiovascular diseases compared to healthy individuals. The study
results were published in the journal eBioMedicine.

Vitiligo is a chronic, multifactorial, autoimmune disease affecting
many individuals worldwide. It is characterized by the presence of hypopigmented
areas on the skin and occurs due to the destruction of melanocytes. Vitiligo individuals
suffer from various systemic disease conditions. Literature shows that
cardiovascular diseases are also prevalent in vitiligo-affected individuals but
the results are ambiguous. Hence, researchers conducted a retrospective
analysis to determine the cardiovascular disease risk in patients with vitiligo.

Also Read: PCSK9 Inhibitors May Reduce Risk of Vitiligo,Promising New Therapeutic Approach, reports study

By using the US Collaborative Network using the TriNetX
platform, retrospective data was retrieved from electronic health records
(EHRs) from 57 US-based healthcare organizations (HCOs). Patients with vitiligo
and controls were identified by their respective ICD10 codes and the risk of
onset of several cardiovascular diseases was determined in patients within 15
years after diagnoses.

Findings:

  • About 94 diagnoses with a prevalence of ≥1% in
    both cohorts were identified.
  • By propensity score matching nearly 96,581
    individuals per group, were identified.
  • Among them, 54 displayed an increased risk of
    vitiligo.
  • Cardiovascular diseases investigated were not associated
    with a decreased risk in patients with vitiligo.
  • It was found that cerebral infarction occurred
    in 1.3% of patients with vitiligo, and 1.0% in controls.
  • Venous thromboembolism was recorded in 1.34% of
    cases and 1.02% of controls without vitiligo.
  • an increased risk of ischemic heart diseases
    including angina pectoris and acute and old myocardial infarction in vitiligo
    was found.
  • Further sensitivity analysis revealed that major
    adverse cardiovascular events (MACE), a composite endpoint have increased
    following a vitiligo diagnosis.
Also Read: Oral Tofacitinib arrests vitiligo progression and induces repigmentation when combined with phototherapy: Study

Thus, the study concluded that there is an increased risk of
cardiovascular diseases in vitiligo individuals when compared to healthy
controls. The researchers also suggested precise monitoring of vitiligo and
their systemic management.

Further reading:

Frączek A, Owczarczyk-Saczonek A, Ludwig RJ, et al. Vitiligo
is associated with an increased risk of cardiovascular diseases: a large-scale,
propensity-matched, US-based retrospective study. EBioMedicine.
Published online October 25, 2024. doi:10.1016/j.ebiom.2024.105423.

Take home points:

  • Vitiligo is an autoimmune disorder.
  • Research on autoimmune diseases showed an
    increased risk of cardiovascular diseases
  • The study found a statistically increased risk
    of 54 cardiovascular diseases.
  • Heart conduction disorders, diseases of
    arteries, arterioles, and capillaries, and heart valve diseases along with MACE,
    and venous thromboembolism are seen in vitiligo individuals.
  • Routine monitoring and prophylaxis should always
    be considered while screening individuals with Vitiligo

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Single leg Stance Duration sensitive and reliable marker of Measure of Neuromuscular Aging, finds study

Researchers found that the duration of single-leg stance was a sensitive and reliable age marker of neuromuscular aging among apparently healthy, asymptomatic populations aged 50 years or older. A recent study was published in PLoS One by Asghar R. and colleagues. The study aimed at exploring the effect of age on gait, balance, and strength and determined if there existed gender differences in these assessments.

This was a cross-sectional survey where healthy adults aged more than 50 years were recruited. Their physical function was evaluated across three core assessments: gait, balance, and strength. Measurements were taken on the dominant side of the body both on the upper extremities (grip) and on the lower extremities (knee). Balance was measured with a force plate, and static stability of four 30-second stance conditions, including bilateral stance while eyes were open, bilateral stance while eyes were closed and unipedal stances on both dominant and nondominant legs while their eyes were open. During level walking, gait for each participant was analyzed by determining dynamic stability margins and Z-scores were again used to determine the change with age on these values.

  • Gait was relatively preserved by aging, and the p-value was nonsignificant indicating no significant changes (p≥0.12).

  • Both grip strength and knee strength declined significantly with advancing age. The strength measure showed the smallest decline with each decade. Grip strength declined by -0.34 SDs, and the decline for knee strength was -0.26 SDs.

  • All of the participants achieved steady bipedal balance, but the center of pressure movement was substantially increased with age (p≤0.028).

  • Both stance durations for the non-dominant and dominant legs decreased with advancing age, and these declines were highly significant; however, the loss of stance duration by decade was more pronounced for the non-dominant leg than the dominant leg (-0.62 SDs vs -0.53 SDs respectively).

  • Notable sex differences were identified only for strength measures, where males had higher grip and knee strength than females.

Unipedal stance time proves to be an appropriate and gender-insensitive indicator of neuromuscular aging having the strong perspective of potential application in the conduct of a geriatric health evaluation.As aging populations continue to grow, reliable assessments like unipedal stance can support proactive care and intervention, improving health outcomes and quality of life for older adults.

Reference:

Rezaei, A., Bhat, S. G., Cheng, C.-H., Pignolo, R. J., Lu, L., & Kaufman, K. R. (2024). Age-related changes in gait, balance, and strength parameters: A cross-sectional study. PloS One, 19(10), e0310764. https://doi.org/10.1371/journal.pone.0310764

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Primary Partial Gland Cryo-Ablation Shows Success in Intermediate-Risk Prostate Cancer, unravels study

New York, NY: A recent prospective cohort study published in Urology Journal has provided encouraging insights into the effectiveness of Primary Partial Gland Cryo-Ablation (PPGCA) for men with intermediate-risk prostate cancer. Over five years, researchers observed significant oncological outcomes, suggesting this innovative treatment could offer a viable alternative to more invasive procedures.

The researchers found that the intermediate-term oncological outcomes following PPGCA were highly encouraging, supported by excellent compliance with a rigorous prospective protocol for detecting recurrent clinically significant prostate cancer (csPCa).

PPGCA, a minimally invasive procedure, targets cancerous cells within the prostate while preserving as much healthy tissue as possible. This approach not only aims to manage cancer but also to reduce the potential side effects often associated with more extensive surgeries. Considering this, Herbert Lepor, Department of Urology, NYU Grossman School of Medicine, New York, NY, and colleagues aimed to evaluate the 5-year oncologic outcomes after PPGCA in patients with intermediate-risk prostate cancer.

For this purpose, the researchers enrolled 476 men undergoing PPGCA in their prospective study on oncologic and functional outcomes. Among these, 313 participants had MRI-concordant intermediate-risk prostate cancer, with no evidence of out-of-field Gleason Grade Group (GGG) ≥2, gross extracapsular extension, or severe apical disease on pre-treatment mpMRI. PSA levels were monitored every six months, and mpMRI assessments were conducted at 6-12, 24, 42, and 60 months.

Following an interim analysis that indicated low rates of clinically significant prostate cancer defined as any GGG≥2 disease, protocol biopsies at 6-12 months and 24 months were discontinued. Freedom-from-failure (FFF) was defined as the absence of prostate cancer-specific mortality, metastatic disease, or whole-gland salvage treatment (WGST).

The following were the key findings of the study:

  • Clinically significant prostate cancer was identified in 10.5% of participants.
  • Among the 91 subjects with at least 4.5 years of follow-up data, the mean number of surveillance procedures included 8.9 PSA tests, 3.4 MRIs, and 2.0 prostate biopsies, with no participants lost to follow-up.
  • At the five-year mark, the rates of freedom from recurrence were as follows:
    • In-field csPCa: 86%
    • Out-of-field csPCa: 85%
    • Overall csPCa: 70%
  • The proportion of participants achieving freedom from failure at five years was 89%.
  • There were no deaths due to prostate cancer; however, one participant (1%) developed metastasis.
  • 16.5% of participants underwent whole-gland salvage treatment, and 16.5% received salvage focal therapy (FT).
  • Compliance with the five-year surveillance protocol was high, with only 3.3% of eligible men being non-compliant.

The prospective 5-year study offers strong oncological evidence supporting the use of Primary Partial Gland Cryo-Ablation (PPGCA) for carefully selected men with intermediate-risk prostate cancer.

“Our previously published results indicate that these favorable oncological outcomes are achieved without rectal injury or urinary incontinence,” the researchers wrote.

Additionally, lower urinary tract symptoms (LUTS) improved with only a modest effect on sexual function. This reinforces the potential of PPGCA as a viable treatment option for this patient population,” they concluded.

Reference:

Lepor, H., Rapoport, E., Tafa, M., Gogaj, R., & Wysock, J. S. (2024). 5-year Oncologic Outcomes Following Primary Partial Gland Cryo-Ablation (PPGCA) Prospective Cohort Study of Men with Intermediate-Risk Prostate Cancer. Urology. https://doi.org/10.1016/j.urology.2024.10.039

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Numbers of Bariatric surgery declining with rise in GLP-1 drugs for treatment of obesity: JAMA

A new study by researchers at Brigham and Women’s Hospital, a founding member of the Mass General Brigham healthcare system, in collaboration with researchers at Harvard T.H. Chan School of Public Health and the Brown School of Public Health, examined a large sample of privately insured patients with obesity and found that use of glucagon-like peptide-1 receptor agonists (GLP-1 RAs) as anti-obesity medications more than doubled from 2022 to 2023. During the same period, there was a 25.6% decrease in patients undergoing metabolic bariatric surgery to treat obesity. The study is published in JAMA Network Open

“Our study provides one of the first national estimates of the decline in utilization of bariatric metabolic surgery among privately insured patients corresponding to the rising use of blockbuster GLP-1 RA drugs,” said senior author Thomas C. Tsai, MD, MPH, a metabolic bariatric surgeon in the Department of Surgery at Brigham and Women’s Hospital.

Using a national sample of medical insurance claims data from over 17 million privately insured adults, the researchers identified patients with a diagnosis of obesity without diabetes in 2022-2023. The study found a sharp increase in the share of patients who received GLP-1 RAs during the study period, with GLP-1 RA use increasing 132.6% from the last six months of 2022 to the last six months of 2023 (from 1.89 to 4.41 patients per 1,000 patients). Meanwhile, there was a 25.6% decrease in use of bariatric metabolic surgery during the same period (from 0.22 to 0.16 patients per 1,000 patients).

Among the sample of patients with obesity, 94.7% received neither form of treatment during the study period (while 5.0% received GLP-1 RAs and 0.3% received surgery). Compared to patients who were prescribed GLP-1 RAs, patients who underwent surgery tended to be more medically complex.

“For now, metabolic bariatric surgery remains the most effective and durable treatment for obesity. National efforts should focus on improving access to obesity treatment—whether pharmacologic or surgical-to ensure patients can receive optimal care,” said Tsai, who is also an assistant professor of Surgery at Harvard Medical School and an assistant professor in Health Policy and Management at Harvard T.H Chan School of Public Health.

Tsai notes that while GLP-1 RAs can effectively treat obesity and related conditions (such as diabetes), these medications have been limited by high costs, limited supply, and gastrointestinal side effects that may prompt treatment cessation and subsequent weight regain.

“As patients with obesity increasingly rely on GLP-1s instead of surgical intervention, further research is needed to assess the impact of this shift from surgical to pharmacologic treatment of obesity on long-term patient outcomes,” Tsai said. “With the national decline in utilization of metabolic bariatric surgery and potential closure of bariatric surgery programs, there is a concern that access to comprehensive multidisciplinary treatment of obesity involving pharmacologic, endoscopic, or surgical interventions may become more limited.”

“These results also highlight an opportunity to further expand uptake of surgical and pharmacologic treatments for obesity and related comorbidities,” said co-author Ateev Mehrotra, MD, MPH, chair of the Department of Health Services, Policy and Practice at the Brown University School of Public Health. “Metabolic bariatric surgery and GLP-1 RAs are both effective interventions for patients with obesity, yet less than 6% of patients in our study received either form of treatment.”

Considering these results, the authors encourage clinicians and policymakers to continue to monitor access to effective obesity treatment amidst a rapidly evolving landscape of treatment options. In addition, further research is needed to understand the tradeoffs between use of surgical intervention versus increasingly popular GLP-1 RAs to treat obesity.

Reference:

Lin K, Mehrotra A, Tsai TC. Metabolic Bariatric Surgery in the Era of GLP-1 Receptor Agonists for Obesity Management. JAMA Netw Open. 2024;7(10):e2441380. doi:10.1001/jamanetworkopen.2024.41380.

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