Need Liver, Will Travel

Posted on October 7, 2016 by gutsandgrowth

A recent commentary (G Cholankeril et al. Gastroenterol 2016; 151: 382-86) provides a succinct summary regarding the trends in liver transplantation multiple listing and its implications on notions of utility and justice.

Key points:

UNOS was established based on Congressional act in 1984: 42 U.S.C. § 274. The principles of “justice” and “utility” were to be key in governing an equitable allocation system.
Due to allocation inequities, however, some prospective liver transplant candidates seek multiple listings. From 2010 to 2015, 1082 of 70,080 (2%) liver transplant candidates on the waitlist had multiple listings. During that same time frame, 862 (multiply-listed) of 32,431(total transplants) (3%) underwent liver transplantation.
Candidates who migrated had “shorter waiting time before liver transplantation and higher probability of receiving an organ (multiple listings 80% versus primary listing 46%; P<.001)”
Multiple listing candidates had lower severity of illness and lower MELD score at time of liver transplantation (multiple listings 25 versus primary listing 28; P<.001)

Regional distribution:

46% of the 862 multiply-listed patients who underwent liver transplantation received their organ in UNOS region 3 (Alabama, Arkansas, Florida, Georgia, Louisiana, Mississippi, Puerto Rico)
67% of those 862 emigrated away from Regions 2, 5, and 9 -which have the longest waiting times. Figure 1 shows the 11 Regions. Region 2 & 9 include New York, New Jersey, Delaware, West Virginia, Maryland, and Pennsylvania. Region 9 includes California, Nevada, Arizona, New Mexico, and Utah.

My take: Under the current system, liver transplant candidates capable of travelling/multiple listing, are rewarded with earlier liver transplantation & higher likelihood of receiving a liver transplant. Thus, until inequities in organ distribution are better addressed, patient’s may need to consider telling their transplant team: ‘Need Liver, Will Travel’

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NEJM Presidential Candidate Health Proposals

Posted on October 6, 2016 by gutsandgrowth

Full text: My Vision for Universal, Quality, Affordable Health Care –NEJM

From NEJM: The editors invited the Democratic and Republican presidential nominees, Hillary Clinton and Donald Trump, to answer the following question for Journal readers: What specific changes in policy do you support to improve access to care, improve quality of care, and control health care costs for our nation? Secretary Clinton responded. Mr. Trump did not respond.

The main topics in Hillary Clinton’s commentary include expanding insurance coverage through the affordable care act (i.e. Obamacare), improve affordability in health care with proposals that affect both insurance companies and pharmaceutical companies, improve access to primary care/community care, and to continue to promote innovation/research.

FDA Expands Use of Cystic Fibrosis Medication

Posted on October 5, 2016 by gutsandgrowth

FDA Expands Use of Orkambi ( lumacaftor/ivacaftor)

Molecular Panels for Identifying Etiology with Acute GI Symptoms

Posted on October 4, 2016 by gutsandgrowth

A recent study (MR Nicholson et al. J Pediatr 2016; 176; 50-6) examined the use of multiplex molecular testing to determine the etiology of acute gastroenteritis in children. It is interesting that little has been published about this increasingly common practice of sending a 12 to 15 panel PCR assay when faced with acute GI symptoms, mainly diarrhea.

This study was a prospective population-based study of children <6 years with acute gastroenteritis (2008-2011).

Findings:

70.4 % (152/216) samples tested positive for a pathogen, with norovirus the most frequent (n=78, 36.1%). Clostridium difficile was next at 16.2% (n=35).
22.7% (n=49) tested positive for more than 1 pathogen including 25 with a C difficile detection
In this study, the authors noted C difficile colonization in 8% of healthy children aged 0-51 months and in 14% of children <12 months

Implications of this study and this technology:

Prior to this technology, traditional approaches typically identified less than 15% of the cases of acute gastroenteritis. Thus, this new technology increases the likelihood of a definitive diagnosis.
Multiple pathogens, particularly with C difficile, illustrate how this new technology will present some difficulties with interpretation. C difficile has very high rates of colonization in infants (anywhere from 25-80%) without AGE symptoms and lower rates of colonization in toddlers. High colonization/detection has been noted in inflammatory bowel disease patients (17%) and pediatric oncology patients (30-55%).
For C difficile, molecular testing is much less likely to correlate with clinical disease than toxin-based assays. “A recent study in adults found that virtually all CDI-related complications occurred in patients with a positive toxin immunoassay.” (JAMA Intern Med 2015; 175: 1792-801)

My take: These panels are helpful in identifying infectious etiologies of AGE and may help prevent unnecessary endoscopic procedures. Due to their limitations, careful selection of which patients to test and cautious interpretation of the results are needed.

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Antipsychotic Agent, Olanzapine, Helps in Reducing Chemotherapy-Induced Nausea/Vomiting

Posted on October 2, 2016 by gutsandgrowth

Briefly noted: RM Navari et al. NEJM 2016; 375: 134-42. Olanzapine (marketed as Zyprexa), compared with placebo, in combination with dexamethasone, aprepitant (or fosaprepitant) and a 5-hydroxytryptomaine type 3 antagonist (eg palonosetron, ondansetron, or granisetron) helped reduced nausea/vomiting. Among a total of 380 patients, 74% in the olanzapine group had no nausea/vomiting compared with 45% in the placebo group in the first 24 hours. In the 1st 120 hours, the rates of no nausea/vomiting were 37% vs. 22%. A “complete response,” defined as no emesis episodes and no rescue medications, occurred in 64% vs 41% in the 1st 120 hours. The most concerning side effect reported was severe sedation which was reported in 5%.

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Increased Intestinal Blood Flow with Bolus Feedings in Very Low Birth Weight Infants

Posted on September 30, 2016 by gutsandgrowth

From Journal of Pediatrics: V Bozzetti et al. DOI: http://dx.doi.org/10.1016/j.jpeds.2016.05.031

Abstract:

Objective

To detect changes in splanchnic perfusion and oxygenation induced by 2 different feeding regimens in infants with intrauterine growth restriction (IUGR) and those without IUGR.

Study design

This was a randomized trial in 40 very low birth weight infants. When an enteral intake of 100 mL/kg/day was achieved, patients with IUGR and those without IUGR were randomized into 2 groups. Group A (n = 20) received a feed by bolus (in 10 minutes), then, after at least 3 hours, received the same amount of formula by continuous nutrition over 3 hours. Group B (n = 20) received a feed administered continuously over 3 hours, followed by a bolus administration (in 10 minutes) of the same amount of formula after at least 3 hours. On the day of randomization, intestinal and cerebral regional oximetry was measured via near-infrared spectroscopy and Doppler ultrasound (US) of the superior mesenteric artery was performed. Examinations were performed before the feed and at 30 minutes after the feed by bolus and before the feed, at 30 minutes after the start of the feed, and at 30 minutes after the end of the feed for the 3-hour continuous feed.

Results

Superior mesenteric artery Doppler US showed significantly higher perfusion values after the bolus feeds than after the continuous feeds. Near-infrared spectroscopy values remained stable before and after feeds. Infants with IUGR and those without IUGR showed the same perfusion and oxygenation patterns.

Conclusion

According to our Doppler US results, bolus feeding is more effective than continuous feeding in increasing splanchnic perfusion.

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FDA Gives Ustekinumab (Stelara) Approval for Crohn’s

Posted on September 29, 2016 by gutsandgrowth

Here’s a link summarizing FDA approval: Medscape: FDA Clears Ustekinumab (Stelara) for Crohn’s Disease

An excerpt:

The US Food and Drug Administration (FDA) has approved ustekinumab (Stelara, Janssen Biotech, Inc) for the treatment of moderately to severely active Crohn’s disease in patients aged 18 years or older.

Specifically, the interleukin-12/23 inhibitor is indicated for Crohn’s patients who have failed or were intolerant to immunomodulator or corticosteroid therapy but who never failed treatment with a tumor necrosis factor (TNF) blocker or who failed or were intolerant to treatment with one or more TNF blockers, according to a company news release.

Ustekinumab is already approved in the United States for treatment of patients with plaque psoriasis and psoriatic arthritis…The clinical development program for ustekinumab for Crohn’s disease included more than 1300 patients across three pivotal phase 3 studies, which served as the primary basis for FDA approval.

In clinical studies of patients who were either new to, experienced with, or failed anti-TNF therapy, between 34% and 56% of patients experienced symptom relief in the 6 weeks after receiving a one-time intravenous induction dose of ustekinumab. “Noticeable improvement was observed as early as 3 weeks,” the company said.

Most patients who responded to induction dosing and who continued ustekinumab treatment with subcutaneous maintenance doses every 8 weeks were in remission at the end of 44 weeks (52 weeks from initiation of the induction dose), the company said.

Full prescribing information and a medication guide are available online.