Newsworthy Tweets: Climate Change, Sugary Beverage Laws, Increasingly Uninsured Children, and Flu Vaccine Effectiveness

Climate change:

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Sugary beverage Law:

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IBD Shorts February 2020

Cost of IBD Care is Increasing. From Healio Gastro: Chronic inflammatory disease expenditures nearly double over last 2 decades Reference: Click B, et al. Poster 22. Presented at: Crohn’s and Colitis Congress; Jan. 23-25, 2020; Austin, Texas

An excerpt from Healio Gastro summary: [Using] the Medical Expenditure Panel Survey (MEPS), a nationally representative database of health care use and expenditure data collected since 1998The researchers assessed total annual, outpatient, inpatient, emergency and pharmacy expenditures in both patients with IBD (n = 641) and RA (n = 641). They used three separate time periods – 1998-2001, 2006-2009 and 2012-2015 –to compare expenditures over time…

Median per-patient annual health care expenditure in patients with IBD was $6,570 compared with $4,010 in patients with RA across all years of the study. Total annual spending increased approximately 2.2 times (95% CI, 1.6-3; P < .01) over the study period and was 36% higher in IBD than RA (P = 0.01).

Pharmaceutical spending increased more than fourfold (95% CI, 3.2-6.1; P < .01) and became the largest cost category (44% total). However, inpatient expenses in IBD decreased 40% over the study period.

My take: While the cost has increased, these new treatments are improving outcomes.  With the emergence of biosimilars, there may be improvement in pharmaceutical spending.

More on Proactive Therapeutic Drug Monitoring (pTDM) Being Helpful: SR Fernandes et al. Inflamm Bowel Dis 2020; 26: 263-70, editorial 271-2.  In this study, a prospective group of patients (n=56) undergoing pTDM were compared with a historical control group (n=149). pTDM had less frequent surgery (9% vs. 21%) and higher rates of mucosal healing (73% vs. 39%).  Treatment escalation was 3 times more common with pTDM than in the control group.

Increased risk of VTE in IBD patientsJD McCurdy et al. Inflamm Bowel Dis 2020; https://doi.org/10.1093/ibd/izaa002

Abstract Link: Risk of Venous Thromboembolism After Hospital Discharge in Patients With Inflammatory Bowel Disease: A Population-based Study

In a population-based study from Ontario, the authors analyzed a total of 81,900 IBD discharges (62,848 nonsurgical and 19,052 surgical) which were matched to non-IBD controls… The cumulative incidence of VTE at 12 months after discharge was 2.3% for nonsurgical IBD patients and 1.6% for surgical IBD patients…Nonsurgical IBD patients and surgical patients with ulcerative colitis are 1.7-fold more likely to develop postdischarge VTE than non-IBD patients.

NY Times: Vitamin K for Newborns is a No-Brainer

One of the most difficult clinical situations I helped manage involved a newborn who had a devastating intracranial hemorrhage after the parents had refused the routine  administration of vitamin K.  At that time, I did not ask the parents what they were thinking.  I presumed that they were well-intentioned.  Nevertheless, they allowed their child to suffer permanent neurologic injury.

A recent editorial highlights this growing problem: NY Times: Vitamin K for Newborns is a No-Brainer Here’s an except:

Parents are increasingly questioning, and declining, vitamin K, which protects newborns from serious bleeding…

Accounts of healthy babies developing serious, even fatal bleeding in the days and weeks following birth can be found going back centuries

Since the early 1960s, it has been standard-of-care for newborns to receive an intramuscular injection of vitamin K shortly after delivery. Nearly six decades’ worth of data demonstrate that this intervention virtually eliminates vitamin K deficiency bleeding and carries no compelling risk of serious side effects…

Many of the reasons my patients’ parents decline vitamin K are similar to the reasons they decline vaccines: They worry about interventions they perceive as “unnatural” or unnecessary, about whether the doses and ingredients are “toxic” and whether there may be serious complications that doctors are not aware of or that are even being purposefully obscured by doctors, public health officials and pharmaceutical companies…

Parents continue to ask me whether vitamin K might cause childhood cancer, though this suggested association has been debunked….Others simply prefer to spare their newborn the pain of an injection…

Each year in the United States, if no vitamin K were administered, more than 70,000 infants would most likely be affected…

The seeds of mistrust — along with skepticism of science and intellectualism, the allure of the “natural” and the development of social-media-fueled communities founded on these values — run deep, and they’re threatening the health of our youngest and most vulnerable.

My take: Just like seat belts, the approach to this problem should be policy-based.  In my view, if an infant suffers from vitamin K-refusal bleeding, reports should be made public health departments.

Related blog post: Educated or Misinformed –Leading to Hemorrhagic Disease of the Newborn

Liver Shorts -February 2020

Caution with hemoglobin A1c interpretation: MM Kelsey et al. J Pediatr 2020; 216: 232-5. In the HEALTHY Study (n=8814), the authors note that a hemoglobin A1c was ≥5.7% in 2% of normal weight youth.  “This suggests need for cautious interpretation of prediabetes hemoglobin A1cs in youth”

Daily aspirin for NAFLD: TG Simon et al. Clin Gastroenterol Hepatol 2019; 17: 2776-84.  In this prospective cohort of 361 adults with biopsy-proven NAFLD, the use of daily aspirin (in 151) was associated with lower odds of NASH (aOR.68) and reduced risk of  fibrosis (aOR 0.54).  “The greatest benefit found with at least 4 years or more of aspirin use” (aHR =0.50).  The associated editorial (pages 2651-3) recommends controlled studies to determine if potential benefits outweigh the known risks (eg. bleeding).

Glecaprevir/pibrentasvir for HCV Treatment Failure:  AS Lok et al. Gastroenterol 2019; 157: 1506-17.  This randomized study with 177 patients showed that 16 weeks of glecaprevir and pibrentasvir was effective in retreatment of patients with genotype 1 hepatitis C viral infection (after prior failure with sofosbuvir plus an NS5A inhibitor).  The sustained virologic response 12 weeks after treatment was >90%.

Liver transplantation for Niemann-Pick Disease, type B:  YLY Luo et al. Liver Transplantation 2019; 25: 1233-40. This report analyzed 7 children receiving liver transplantation for Niemann-Pick disease, type B.  The authors report survival in the entire cohort and with normalized liver function within 3 weeks.  In addition, they noted improvement in psychomotor ability ( 10 months after transplantation) and resolution of insterstitial lung disease.  They state that developmental delay still existed in 4 patients during follow-up.  The editorial (1140-1) notes that these findings need to be confirmed but open a new window in improving the phenotype.  “A similar experience occurred with LT in maple syrup urine disease (MSUD), in which the liver is considered to host only 12-15% of the defective  enzyme responsible for the disease…in MSUD, liver replacement is able to counteract 85% of extrahepatic expression of the disease and to completely correct the phenotype.”

Increased Abdominal-Surgery Risk in Patients with Idiopathic Noncirrhotic Portal Hypertension: L Elkrief et al. Hepatology 2019; 70: 911-24. Among 44 patients (median age 44 years) with noncirrhoitic portal hypertension, 16 (33%) had one or more portal hypertension-related complication within 3 months after surgery.  4 (9%) died within 6 months.  “An unfavorable outcome (i.e. either liver or surgical complication or death) occurred in 22 (50%) patients” and was more likely in those with ascites, creatinine >100 micromol/L, or other extrahepatic complications related to portal hypertension.

One of my blog readers shared this image of “Liver Shorts” that can be purchased online

Clinical Practice Advice: Pancreatic Necrosis

Recently the AGA published expert practice advice for pancreatic necrosis: TH Baron et al. Gastroenterol 2020; 158: 67-75.

Link to full-text PDF:  American Gastroenterological Association Clinical Practice Update: Management of Pancreatic Necrosis.  The link includes 5 figures which provide algorithms based on their recommendations.

I’ve copied their 15 best practice advice below and highlighted the most useful.  Early in the course of pancreatic necrosis, it can be difficult to discern if an infection is present due to a robust inflammatory response; some findings suggestive of infection include gas in the collection, bacteremia, sepsis, or clinical deterioration.  Generally, surgical, endoscopic or radiologic intervention is more optimal when there is a walled-off pancreatic necrosis (WON) which typically takes 4 weeks or more.

Best Practice Advice 1

Pancreatic necrosis is associated with substantial morbidity and mortality and optimal management requires a multidisciplinary approach, including gastroenterologists, surgeons, interventional radiologists, and specialists in critical care medicine, infectious disease, and nutrition. In situations where clinical expertise may be limited, consideration should be given to transferring patients with significant pancreatic necrosis to an appropriate tertiary-care center.

Best Practice Advice 2

Antimicrobial therapy is best indicated for culture-proven infection in pancreatic necrosis or when infection is strongly suspected (ie, gas in the collection, bacteremia, sepsis, or clinical deterioration). Routine use of prophylactic antibiotics to prevent infection of sterile necrosis is not recommended.

Best Practice Advice 3

When infected necrosis is suspected, broad-spectrum intravenous antibiotics with ability to penetrate pancreatic necrosis should be favored (eg, carbapenems, quinolones, and metronidazole). Routine use of antifungal agents is not recommended. Computed tomography–guided fine-needle aspiration for Gram stain and cultures is unnecessary in the majority of cases.

Best Practice Advice 4

In patients with pancreatic necrosis, enteral feeding should be initiated early to decrease the risk of infected necrosis. A trial of oral nutrition is recommended immediately in patients in whom there is absence of nausea and vomiting and no signs of severe ileus or gastrointestinal luminal obstruction. When oral nutrition is not feasible, enteral nutrition by either nasogastric/duodenal or nasojejunal tube should be initiated as soon as possible. Total parenteral nutrition should be considered only in cases where oral or enteral feeds are not feasible or tolerated.

Best Practice Advice 5

Drainage and/or debridement of pancreatic necrosis is indicated in patients with infected necrosis. Drainage and/or debridement may be required in patients with sterile pancreatic necrosis and persistent unwellness marked by abdominal pain, nausea, vomiting, and nutritional failure or with associated complications, including gastrointestinal luminal obstruction; biliary obstruction; recurrent acute pancreatitis; fistulas; or persistent systemic inflammatory response syndrome.

Best Practice Advice 6

Pancreatic debridement should be avoided in the early, acute period (first 2 weeks), as it has been associated with increased morbidity and mortality. Debridement should be optimally delayed for 4 weeks and performed earlier only when there is an organized collection and a strong indication.

Best Practice Advice 7

Percutaneous drainage and transmural endoscopic drainage are both appropriate first-line, nonsurgical approaches in managing patients with walled-off pancreatic necrosis (WON). Endoscopic therapy through transmural drainage of WON may be preferred, as it avoids the risk of forming a pancreatocutaneous fistula.

Best Practice Advice 8

Percutaneous drainage of pancreatic necrosis should be considered in patients with infected or symptomatic necrotic collections in the early, acute period (<2 weeks), and in those with WON who are too ill to undergo endoscopic or surgical intervention. Percutaneous drainage should be strongly considered as an adjunct to endoscopic drainage for WON with deep extension into the paracolic gutters and pelvis or for salvage therapy after endoscopic or surgical debridement with residual necrosis burden.

Best Practice Advice 9

Self-expanding metal stents in the form of lumen-apposing metal stents appear to be superior to plastic stents for endoscopic transmural drainage of necrosis.

Best Practice Advice 10

The use of direct endoscopic necrosectomy should be reserved for those patients with limited necrosis who do not adequately respond to endoscopic transmural drainage using large-bore, self-expanding metal stents/lumen-apposing metal stents alone or plastic stents combined with irrigation. Direct endoscopic necrosectomy is a therapeutic option in patients with large amounts of infected necrosis, but should be performed at referral centers with the necessary endoscopic expertise and interventional radiology and surgical backup.

Best Practice Advice 11

Minimally invasive operative approaches to the debridement of acute necrotizing pancreatitis are preferred to open surgical necrosectomy when possible, given lower morbidity.

Best Practice Advice 12

Multiple minimally invasive surgical techniques are feasible and effective, including videoscopic-assisted retroperitoneal debridement, laparoscopic transgastric debridement, and open transgastric debridement. Selection of approach is best determined by pattern of disease, physiology of the patient, experience and expertise of the multidisciplinary team, and available resources.

Best Practice Advice 13

Open operative debridement maintains a role in the modern management of acute necrotizing pancreatitis in cases not amenable to less invasive endoscopic and/or surgical procedures.

Best Practice Advice 14

For patients with disconnected left pancreatic remnant after acute necrotizing mid-body necrosis, definitive surgical management with distal pancreatectomy should be undertaken in patients with reasonable operative candidacy. Insufficient evidence exists to support the management of the disconnected left pancreatic remnant with long-term transenteric endoscopic stenting.

Best Practice Advice 15

A step-up approach consisting of percutaneous drainage or endoscopic transmural drainage using either plastic stents and irrigation or self-expanding metal stents/lumen-apposing metal stents alone, followed by direct endoscopic necrosectomy, and then surgical debridement is reasonable, although approaches may vary based on the available clinical expertise.

Related blog post: NASPGHAN 2017 Postgraduate Course Part 1 -includes slides on pancreatic fluid collection management

 

Is Tenofovir the Best Medication for Hepatitis B Infection?

Two recent studies have suggested that tenofovir may be more effective for hepatitis B virus (HBV) infections.

  • T C-F Yip et al. Gastroenterol 2020; 158: 215-25.
  • J Choi et al. JAMA Oncol 2019; 5: 30-6. (Reviewed in a commentary by P Lampertico, M Colombo. Gastroenterol 2019; 157: 1682-88)

In the first retrospective study from Hong Kong, the authors analyzed 29,350 consecutive treated-patients  (mean age 52.9 years).  1309 were treated with tenofovir disoproxil fumarate (TDV) and 28,041 were treated with entecavir. Key findings:

  • TDF-treated patients were younger (mean age 43.2 years vs. 53.4 years) and had less cirrhosis at baseline (2.9% vs. 13.6%).
  • After a median follow-up of 3.6 years, 8 TDF-treated patients (0.6%) and 1386 (4.9%) of entecavir-treated patients developed hepatocellular carcinoma (HCC).  The authors note that TDF maintained a lower rate of HCC after propensity score weighting (hazard ratio of 0.36)

The second study was a nationwide population cohort database with >24,000 patients –all with ALT >80. Key finding:

  • HCC was significantly lower in TDF group than in the entecavir group, the percent person-years being 0.64 compared to 1.06; though, there was not a lower mortality rate or a lower liver transplantation rate.

The commentary associated with the latter study makes the following points:

  • Both TDF and entecavir could prevent “the incidence and mortality of HCC …in >85% of patients who received [them] for years.”
  • Studies comparing TDF and entecavir have come up with conflicting results.  “Three studies in Korea, the U.S, and Europe reported no differences between NAs even after patient matching by a propensity score.”
  • “Cumulatively, all these studies deliver the reassuring message of a robust risk reduction of liver cancer taking place in patients with chronic hepatitis B who experience prolonged virus suppression after NA therapy, but currently they fail to provide convincing evidence that one NA is superior to the other one in determining such clinical benefit.”

My take: Tenofovir may be better but the answer is not definitive; due to lack of randomization, there may still be confounding variables in which sicker patients are receiving entecavir and this could be contributing to the difference in outcomes.  Also, in patients with bone disease and renal impairment, tenofovir alafenamide (TAF) or entecavir is recommended.

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From P’tit Train Du Nord Linear Park

What Are The Limits of (Preterm) Viability?

A retrospective recent study (PL Watkins et al. J Pediatr 2020; 217: 52-8) provides data that suggests that preterm infants at 22-23 weeks gestation can have good outcomes.

Cohort:

  • n=70 for 22-23 weeks (22 weeks, n=20, 23 weeks, n=50)
  • n=178 for 24-25 weeks (24 weeks, n=79, 25 weeks, n=99)

Key findings:

  • Survival to hospital discharge: 78% for 22-23 week cohort, 89% for 24-25 week cohort
  • No or mild neurodevelopmental impairment 64% or 22-23 week cohort, 76% for 24-25 week cohort. This was based on prospectively collected data at 18-22 months with Bayley Scales (BSID-III) (≥85) and being free from vision and hearing impairment

These survival and neurodevelopmental outcomes far exceed previous reports.  The study and the associated editorial (pg 9) identify several treatment characteristics that could have helped optimize outcomes: antenatal steroids, high-frequency ventilation, and a specialized environment.  Also, the authors did not include infants who were outborn, stillborn or died in the delivery room.

My take: This article’s data needs to be replicated elsewhere; in the meanwhile, it is going to challenge the notion of nihilism for infants born at 22-23 weeks gestation.

Related article: AH Jobe. J Pediatr 2020; 217: 184-8.  This commentary discusses the potential lifetime consequences of antenatal steroids, which may affect neurodevelopment and cardiovascular outcomes. “Antenatal corticosteroids are frequently used to disrupt normal development in rodent models”

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