Timing of Upper Endoscopy with GI Bleeding -Is It Safer to Wait a Bit?

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YouTube Video –Adley.TV: What We Should ALL Be Doing Right Now (COVID-19 Humor)

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A recent study (JYW Lau et al. NEJM 2020; 382: 1299-1308, editorial by L Laine 1361-2) indicates that performing an upper endoscopy within the first 6 hours of presentation to the hospital is NOT associated with better outcomes.

516 patients who were predicted to be at high risk for further bleeding or death were randomly assigned to undergo endoscopy within 6 hours or between 6-24 hours. Key findings:

  • 30-day mortality: 8.9% in the <6 hr group (<6G) compared to 6.6% in the 6-24 hr group (6-24G)
  • Endoscopic treatment was administered to 60.1% of <6G compared to 48.4% in 6-24G
  • Re-bleeding within 30 days in 10.9% of <6G compared to 7.8% in 6-24G

The editorial notes that guidelines recommend endoscopy be performed within 24 hours following hemodynamic resuscitation and attention to other coexisting conditions before endoscopy.

My take: This is good news for endoscopists -no need to rush to the endoscopy suite/operating room in the middle of the night!

Link NEJM: Two minute quick take on article

Related blog posts:

 

Brief Updates: COVID-19/Hydroxychloroquine, GALD, Anorexia Nervosa, and Esophaeal-gastric Dissociation Outcomes

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Recent reports indicate that hydroxychloroquine is not likely effective for COVID-19.  Submitted manuscript: Outcomes of hydroxychloroquine usage in United States veterans hospitalized with Covid-19 Commentary from Politco: More deaths, no benefit from malaria drug in VA virus study

An excerpt: A malaria drug widely touted by President Donald Trump for treating the new coronavirus showed no benefit in a large analysis of its use in U.S. veterans hospitals….The study was posted on an online site for researchers and has been submitted to the New England Journal of Medicine, but has not been reviewed by other scientists….About 28% who were given hydroxychloroquine plus usual care died, versus 11% of those getting routine care alone. About 22% of those getting the drug plus azithromycin died too, but the difference between that group and usual care was not considered large enough to rule out other factors that could have affected survival…The NIH and others have more rigorous tests underway.

HS Fischer et al. JPGN 2020; 70: 444-9. This study examined outcomes of 12 patients with gestational alloimmune liver disease over an 11 year period. Key findings:

  • Median age at diagnosis of neonatal acute liver failure (NALF): 2 days
  • All 12 received exchange transfusion ET).  Common signs: hypoglycemia, hyperferritinemia, cholestasis, and coagulopathy. Direct bilirubin typically increased after ET.
  • Outcomes: survival without transplantation occurred in 10 of 12.  Two patients died including one after liver transplantation.
  • “Most cases of NALF are due to GALD and should be timely treated with ET and IVIG.”  Current testing is lacking with regard to sensitivity and specificity, “early ET [and IVIG] before reaching a definitive diagnosis was associated with favorable outcomes.”

Related blog posts:

JE Mitchell, CB Peterson. Anorexia Nervosa (good review). NEJM 2020; 382: 1343-51.

Key points: 

  • Anorexia nervosa is a severe psychiatric disorder
  • Indications for hospitalization include profound hypotension or dehydration, severe electrolyte abnormalities, arrhythmias or severe bradycardia, suicide risk or BMI ≤15

Related blog posts:

S Battaglia et al. JPGN 2020; 70: 457-61. This retrospective study examined outcomes in 30 patients with severe neurologic impairment who underwent esophageal-gastric dissociation (E-GD) between 2000-18 and had a median follow-up of 3.5 years. E-GD was completed at a median age of 6.5 years. “Primary” E-GD was done in 23 and “Rescue” (after fundoplication) was done in 7 patients.

  • Hospitalizations and episodes of chest infections significantly decreased; weight improved
  • Vomiting and reflux resolved in all patients
  • 6 (20%) experienced early complications including 3 who needed surgery (1 obstruction, 1 volvulus, and 1 pyloric obstruction); 3 (10%) had late complications (adhesions/obstruction in 1, incisional hernia in 1, large para-esophageal hernia in 1)
  • There were no surgery-related deaths

The authors, in their discussion, compare primary E-GD with fundoplication.  Many of the referenced studies indicate that E-GD may have improved outcomes in the population of children with severe neurologic impairment, but also with a higher frequency of complications.  They conclude that E-GD “is a valid alternative to fundoplication…but is is just as effective and feasible when undertaken as a ‘Rescue’ procedure following failed surgical antireflux treatment.”

My take: The frequency of fundoplication operations have dropped markedly with increasing use of gastrojejunal tube placement.  In my view, I would usually recommend E-GD for ‘rescue’ after fundoplication failure.

A recent yard sign from my wife for neighborhood walkers during the pandemic

 

Get Ready for 2021 Coding Changes

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MDEdge GI Hep News: Prepare for major changes to E/M coding starting in 2021

New Evaluation and Management (E/M) codes are coming in 2021 –this could simplify documentation.

Here’s an excerpt:

1.Elimination of history and physical as elements for code selection

2. Choice of using medical decision making (MDM) or total time as the basis of E/M level documentation

  • MDM. While there will still be three MDM subcomponents (number/complexity of problems, data, and risk), extensive edits were made to the ways in which these elements are defined and tallied.
  • Time. The definition of time is now minimum time, not typical time or “face-to-face” time. Minimum time represents total physician/qualified health care professional time on the date of service

3. Modification of the criteria for MDM:

  • Terms. Removed ambiguous terms (e.g., “mild”) and defined previously ambiguous concepts (e.g., “acute or chronic illness with systemic symptoms”).
  • Definitions. Defined important terms, such as “independent historian.”
  • Data elements. Re-defined the data elements to move away from simply adding up tasks to focusing on how those tasks affect the management of the patient (e.g., independent interpretation of a test performed by another provider and/or discussion of test interpretation with another physician).

4. Modifier/add-on code): GPC1X can be reported with all levels of E/M office/outpatient codes in which care of a patient’s single, serious, or complex chronic condition is the focus. CMS plans to reimburse GPC1X at 0.33 RVUs (about $12).

Resources:

“Contact your Electronic Health Records (EHR) vendor to confirm the system your practice uses will be ready to implement the new E/M coding and guidelines changes on Jan. 1, 2021.”

My take: The intent of these changes is logical.  The goal of coding is to align the reimbursement with the degree of effort and not simply allow pre-formatted templates justify upcoding.  They could lead to simplification of documentation and allow more documentation time for medical decision-making part of the visit.

Related blog posts:

AMA Table 2 for E/M codes 212-215, 202-205

 

 

 

 

 

NY Times: America can afford a world-class health system. Why don’t we have one?

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Yesterday’s NY Times had a terrific review section of the paper with the theme of “The America We Need.”  The section highlighted the interaction between the coronavirus and inequality, unemployment, collective action, and emerging threats (eg. climate change).

The article with the most relevance for medicine was titled: America can afford a world-class health system. Why don’t we have one?

Here’s an excerpt:

The notion of price control is anathema to health care companies. It threatens their basic business model, in which the government grants them approvals and patents, pays whatever they ask, and works hand in hand with them as they deliver the worst health outcomes at the highest costs in the rich world.

The American health care industry is not good at promoting health, but it excels at taking money from all of us for its benefit. It is an engine of inequality…

America is a rich country that can afford a world-class health care system. We should be spending a lot of money on care and on new drugs. But we need to spend to save lives and reduce sickness, not on expensive, income-generating procedures that do little to improve health. Or worst of all, on enriching pharma companies that feed the opioid epidemic.

The first step to reform is to change the way we think…It would be more accurate to think of employer-provided health insurance as a tax….

Employer-based health  insurance is a wrecking ball, destroying the labor market for less-educated workers and contributing to the rise in “deaths of despair.”…

To meet those rising costs, states have cut their financing for roads, bridges and state universities. Without those crucial investments, the path to success for many Americans is cut off. We face a looming trillion-dollar federal deficit caused almost entirely by the rising costs of Medicaid and Medicare, even without the recent coronavirus relief bill…

Americans have too few doctors, too few beds and too few ventilators — but lots of income for providers. While millions suffer, our health care system has turned into an inequality machine, taking from the poor and working class to generate wealth for the already wealthy…

The health care industry has armored itself, employing five lobbyists for each elected member of Congress. But public anger has been building — over drug prices, co-payments, surprise medical bills — and now, over the fragility of our health care system, which has been laid bare by the pandemic…

Employer-based health care is a particular nightmare in this pandemic. In recent weeks, millions have lost their paychecks and their insurance, and will have to face the virus without either.

We are believers in free-market capitalism, but health care is not something it can deliver in a socially tolerable way.

My take: Many health care workers and hospital employees are showing incredible courage and compassion in this pandemic.  This article reminds us of all the work needed to improve our health care system.

Related blog posts:

 

Curbside humor -my wife is leaving different jokes everyday for neighborhood walkers

From CNN:

Bigger Data Needed and Other IBD Updates April 2020

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R Pittayanon et al. Gastroenterol 2020; 158: 930-46.  In this systematic review of the relationship between gut microbiota and inflammatory bowel disease, 48 studies and 45 articles were included from a total of 2631 citations.  Overall, the authors found inconsistent results with differences in the abundances of some bacteria in IBD. My take: These microbiota studies use ‘big data’ to look for abnormal patterns in patients with IBD.  Overall, most of these studies support a reduced diversity among patients with IBD.  Specific variation in microbes varies widely and remains unclear if they are a cause or a consequence of IBD.

J Piercy et al. JPGN 2020; 70: 318-23. Among 90 adolescents with IBD, “perfectionistic concerns (self-critical and socially prescribed perfectionism) were associated with higher rates of adolescent-reported externalizing symptoms” Thus, perfectionism may help with self-management but lead to more stress and psychosocial symptoms.

S Jardine et al. Gastroenterol 2020; 158: 1000-15. This study used both TTC7A-knockout cells and a zebrafish model to screen compounds that have been FDA approved for treatment of inflammatory bowel disease caused by TTC7A deficiency.  The authors identified leflunomide that reduces apotosis and levels of active caspase 3 in TTC-7A-knockout cells and restored gut motility along with improvement of intestinal cell survival in zebrafish. This study has some amazing figures detailing the changes induced by leflunomide. My take: Although some centers have offered hematopoetic stem cell transplant (with dismal results), there is NOT a currently accepted treatment for TTC7A deficiency-induced IBD.  This study suggests an agent which may help.

CLD Prevost et al. AP&T 2020. https://doi.org/10.1111/apt.15681 Key finding:  Among patients exposed to anti‐TNF, the Lémann Index was lower in those who were exposed in the first 2 years of their disease (P = 0.015).  My take: Early treatment with anti-TNF agents can reduce risk of permanent bowel damage. This was seen as well in the RISK study which showed that anti-TNF therapy reduced the development of penetrating disease. (Related post: CCFA Update 2017, Part 3)

Full link: Bowel damage and disability in Crohn’s disease: a prospective study in a tertiary referral centre of the Lémann Index and Inflammatory Bowel Disease Disability Index

Impedance May Help in Borderline Reflux Disease Assessment

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A recent retrospective study (A Rengarajan et al. Clin Gastroenterol Hepatol 2020; 18: 589-95), with a cohort of 371 patients (mean age 54 years) shows how impedance testing may help identify patients who are likely to respond to reflux management when pH probe testing is equivocal.  The cohort included adults with persistent reflux symptoms.  Response to antireflux therapy was defined as >50% improvement in esophageal symptoms.

Key points:

  • 107 (28.8%) had pathologic acid exposure time (AET) (pH<4 for >6%)
  • 234 (63.1%) had abnormal mean nocturnal baseline impedance (MNBI) (<2292 ohms). MNBI was calculated using baseline values at 10-minute periods between 1-3 am from the 5 cm channel to correspond to total distal AET.
  • Figure 1, shows the combined use of AET and MNBI.  Only 106/107 patients with AET>6, had an abnormal MNBI.  In the borderline category of AET 4-6%, 62/68 (91.2%) had abnormal MNBI values. In those with AET <4, MNBI was abnormal in 66/196 (33.7%)

Response to Treatment:

  • Among patients with AET >6, 66/89 (74%) responded to medical therapy and 18/23 (78%) responded to surgical therapy; among patients with AET 4-6%, 37/56 (66%) responded to medical therapy and 14/17 (82%) responded to surgical therapy. In those with AET <4, 39/185 (21%) responded to medical therapy and 16/23 (70%) responded to surgical therapy
  • Among patients with a low MNBI, 119/198 (60%) responded to medical therapy and 41/50 (82%) to surgical therapy.  In those with a normal MNBI, 23/132 (17%) responded to medical therapy and 7/13 (54%) responded to surgical treatment
  • In those with AET >6, 84/111 (76%) responded to treatment. For those with AET 4-6%, of those with low MNBI, 49/67 (73%), responded (similar to those with AET >6%).  In those with low MNBI and AET <4, 27/70 (39%) responded to treatment
  • 28/138 (20.2%) with normal AET <4 and with normal MNBI responded to treatment

My take: The big takeaway is that all of our tests for pathologic reflux are highly flawed; impedance may (to a small degree) help stratify patients with equivocal evaluation based on AET.  Normal tests do not exclude response treatment (especially surgery).

Related blog posts:

Island Ford, Sandy Springs

 

Two Studies: 1. COVID-19 Transmissibility 2.Fecal Microbiota Transplantation in 372 Children

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A study in Nature suggests that more than 40% of SARS-CoV-2 infections (COVID-19 viral infections) are spread in the presymptomatic stage: Temporal dynamics in viral shedding andtransmissibility of COVID-19 (Thanks to Steven Liu for this reference).

An excerpt:
We report temporal patterns of viral shedding in 94 patients with laboratory-confirmed COVID-19 and modeled COVID-19 infectiousness profiles from a separate sample of 77 infector–infectee transmission pairs. We observed the highest viral load in throat swabs at the time of symptom onset, and inferred that infectiousness peaked on or before symptom onset. We estimated that 44% (95% confidence interval, 25–69%) of secondary cases were infected during the index cases’ presymptomatic stage, in settings with substantial household clustering, active case finding and quarantine outside the home. Disease control measures should be adjusted to account for probable substantial presymptomatic transmission.

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A recent retrospective multi-center study (MR Nicholson et al. Clin Gastroenterol Hepatol 2020; 18: 612-9) provides data on fecal microbiota transplantation (FMT) for Clostridium difficile infection (CDI). Congratulations to one of my partners, Jeffery Lewis, who is one of the coauthors. This paper’s abstract is noted in a separate blog: Large Study Show FMT Efficacy/Safety in Children.

Though this is a pediatric study, the authors included patients up to 23 years.  335 of the patients had followup for at least 2 months following FMT.

Key findings:

  • 81% of patients had a successful outcome after a single FMT and 86.6% after single or repeated FMT
  • Higher success rates were associated with fresh donor stool (OR 2.66), FMT via colonoscopy (OR 2.41), and with not having a feeding tube (OR 2.08)
  • Though not reaching statistical significance, patients with inflammatory bowel disease had a high failure rate of 23% (26/111).  Short bowel syndrome patients had a 50% failure rate (5/10), solid organ transplant recipients had a 56% failure rate (5/9), and patients with feeding tubes had a 32% failure rate (21/65).
  • Seventeen patients (4.7%) had a severe adverse event during the 3-month follow-up period, including 10 hospitalizations; however, the majority were unrelated to FMT. Specific adverse reactions that were related or may have been included aspiration pneumonia on day of procedure (n=1), IBD flare/colectomy (n=5), and vomiting/dehydration (n=1)
  • Common adverse reactions included diarrhea, abdominal pain, and bloating. (These symptoms have been reported in up to 70% of adults following FMT.)

The authors note that a prior systematic review had indicated that delivery of FMT via colonoscopy was more successful in adults (95% vs 88%), though there are some additional risks with colonoscopy.

It is worth considering that the failure rate in some patients could be due to misdiagnosis, particularly in certain populations like patients with IBD and or organ transplant recipients.  In these populations, PCR assays may result in false-positive diagnosis and should be confirmed with an ELISA assay.   While eradication of CDI with FMT improves clinical symptoms and reduces the use of antibiotics the true benefit and risks will not be known for a long time.  Does FMT increase or reduce the risk of downstream infections, autoimmune disease, and metabolic syndrome?

My take: Many of the concerns with FMT can only be adequately addressed with prospective studies (with strict definitions of CDI) and longer followup.

Related blog posts:

Island Ford, Sandy Springs

What Happens After The First Anti-TNF Agent Doesn’t Work?

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A recent intriguing retrospective study (MJ Casanova et al. Inflamm Bowel Dis 2020; 26: 606-16, editorial 617-18) examines a large cohort (n=1122) who received either a 2nd or 3rd anti-TNF agent.  This relied on the ENEIDA registry which is a prospectively maintained registry from Spain with 11,866 patients. In this study, clinical remission was gauged with a Harvey Bradshaw Index score of ≤4 in Crohn’s disease (CD) or a partial Mayo score of ≤2 in ulcerative colitis (UC).

Key findings:

  • 45% of patients achieved remission with the second anti-TNF at 12 weeks (short-term); loss of response was 19% per patient-year subsequently. Patients with intolerance to the first drug had higher remission rates compared to those who switched due to secondary failure (52% vs 42%) or primary failure (52% vs 39%).
  • Among the 45% who responded to a second anti-TNF agent, 77% maintained remission at 1 year following switch.
  • There was similar initial response to a second anti-TNF among patients with CD and UC: 46% vs 41%, though patients with UC were more likely to lose efficacy.
  • Combination therapy was associated with a higher likelihood of failure, HR 2.4 (possibly as an indicator of more aggressive disease)
  • Among the 71 patients who progressed to a 3rd anti-TNF agent, 55% achieved remission at 12 weeks. 

Discussion:

  • The authors in their discussion not that “primary failure is considered a class effect phenomenon…However, our results indicate that remission may still be achieved with a second anti-TNF in approximately 50% of patients.”
  • The editorial notes that the results need to be interpreted with caution.  Therapeutic drug monitoring (TDM) which is not incorporated in this study is crucial in optimizing response and switching.  “Importantly, nearly two-thirds of patients with therapeutic drug levels in the study form the Mayo Clinic had no active inflammation.  Thus, a change in therapy would be inappropriate in this population.”

My take: This study indicates that a 2nd anti-TNF agent can be effective in those who do not respond to a 1st.  At the same time, careful assessment including TDM is needed when changing agents, especially in view of the limited number of effective therapies.

Related blog posts:

From Atlanta Botanical Garden

COVID-19 Daily Deaths & Asymptomatic Infections

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Recent data show why experts were concerned about SARS-CoV-2 (COVID-19 Virus) several months ago, due to its potential for exponential spread. Even now many question whether this infection is more significant than influenza.

Link: COVID-19 Daily Deaths

Several screenshots:

NEJM Link: Universal Screening for SARS-CoV-2 in Women Admitted for Delivery

An excerpt:

Between March 22 and April 4, 2020, a total of 215 pregnant women delivered infants at the New York–Presbyterian Allen Hospital and Columbia University Irving Medical Center [NYC] …

Most of the patients who were positive for SARS-CoV-2 at delivery were asymptomatic, and more than one of eight asymptomatic patients who were admitted to the labor and delivery unit were positive for SARS-CoV-2. Although this prevalence has limited generalizability to geographic regions with lower rates of infection, it underscores the risk of Covid-19 among asymptomatic obstetrical patients. Moreover, the true prevalence of infection may be underreported because of false negative results of tests to detect SARS-CoV-2

My take: This study indicates that there are a lot of undetected cases of SARS-CoV-2.

 

Stony Brook Univeristy’s Innovations to manage COVID-19 Crisis -NEJM: Staying Ahead of the Wave

Some tips:

Related blog posts:

 

 

Ups (mostly) and Downs with IBD Epidemiology

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Two articles describe both increasing and decreasing trends in the prevalence of inflammatory bowel disease (IBD).

  • Y Ye et al. Inflamm Bowel Dis 2020; 26: 619-25, editorial 626-27
  • M Torabi et al. Inflamm Bowel Dis 2020; 26: 581-90, editorial 591-92 

The first study by Ye et al provides the familiar message that IBD prevalence has been increasing in pediatrics and adults.  This study examined 2 large claims databases.  The Optum database covered ~18 million annually during the study period (total ~57 million from 2007-2017) and Truven covered ~44 million annually (total ~240 million since 1995)

Key findings:

  • Pediatric IBD prevalence increased by 133% from 2007 to 2016: from 33 per 100,000 to 77 per 100,000. Crohn’s disease (CD) was twice as prevalent as ulcerative colitis (UC) in the pediatric population (46 vs 22)
  • Adult IBD prevalence increased by 123% from 2007 to 2016: from 215 per 100,000 to 478 per 100,000. The prevalence rates of CD and UC were similar in adults: 198 vs 181)
  • The Northeast region had the highest prevalence of IBD, followed by Midwest, South and then West.
  • Based on these prevalence data, there are an estimated 58,000 children (2-17) and 1.2 million adults with IBD in U.S.   Or, 1 in 1299 children and 1 in 209 adults.

Limitations:

  • Diagnosis and data derived from claims database
  • Cases can vary significantly based on how sensitive the definition for IBD is in a given study.  In this study, the authors indicate in supplementary material, that the prevalence rates could be doubled in adults if they chose a more sensitive/less specific case definitions.

The second study by Torabi et al, which utilized the Manitoba Epidemiology Database (n=1.2 million) showed a decrease in IBD incidence.  The authors examined 296 small geographic areas (SGAs) and found that many had persistently high IBD incidence rates.

Key findings:

  • The incidence of IBD decreased from 1990 when it was 23.6 per 100,000 to 16.2 per 100,000 in 2012.
  • In the study period (1990-2012), there were 3114 cases of CD and 3499 cases of UC diagnosed in Manitoba

In the discussion, the authors speculate on the reasons for the decline in IBD incidence in an area with high rates of IBD.  Some of the change may be related to changes in the population mix –more immigrants from areas with lower rates of IBD.  In the editorial, it is noted that a recent systematic review (Lancet 2018; 390: 2769-78) indicated that the “incidence of IBD is stabilizing in Western countries.”

My take: There are a lot kids and adults with IBD.  The preponderance of epidemiology studies point to increasing incidence and prevalence.

Related blog posts:

Rock art during “social distancing”