Episode 195: 195. Medical Update-- GERD guidelines, IV iron, bariatric surgery, DOAC and the Frail Pmts

European Heart Journal

Bariatric surgery and cardiovascular disease: a systematic review and meta-analysis

Eur Heart J 2022 Mar 04;[EPub Ahead of Print], SL van Veldhuisen, TM Gorter, G van Woerden, RA de Boer, M Rienstra, EJ Hazebroek, DJ van Veldhuisen

39 studies, all prospective or retrospective cohort studies, showed Bariatric surgery is associated with a reduced hazard ratio (HR) of CV morality (0.59), all-cause mortality (0.55), incident HF (0.50), myocardial infarction (0.58) and stroke (0.64)

Authors state “”The present systematic review and meta-analysis suggests that bariatric surgery is associated with reduced all-cause and CV mortality, and lowered incidence of several CV diseases in patients with obesity. Bariatric surgery should therefore be considered in these patients.”””

Here is the problem and I have said it before—“no randomized control trials examining the effect of bariatric surgery on CV outcomes,”

Among frail patients with AF, OAC treatment was associated with a positive net clinical outcome. Direct OACs provided lower incidences of stroke, bleeding, and mortality, compared with warfarin.

Just talked recently about continue doac in hospice and everyone agrees that is bad but ultimately there are very few conditions in which you should not resume anticoag—even in those with GI bleed, falls, or subachrnoid hemerage—the data suggest the pts are better off back on anticoag. Well this study looked at the frail.

In this retrospective cohort study analyzed 83 635 patients with mean age 78.5 those individuals who were on ORAL anticoag(doac or warfarin) had overall lower risks of ischemic stroke (HR, 0.91) and cardiovascular death (HR, 0.52), with no significant difference in major bleeding (HR, 1.02),

Bottom line- restart the OAC – even in the frail to prevent the outcomes we really care about like stroke and death

Dave CV et al. Risks for anaphylaxis with intravenous iron formulations: A retrospective cohort study. Ann Intern Med 2022 Mar 29; [e-pub]. (https://doi.org/10.7326/M21-4009. opens in new tab)

Anaphylaxis occurs rarely with intravenous (IV) iron does happen but how often does it happen?? It is a mystery—till now

Using a retrospective cohort design, investigators assessed 167,000 U.S. Medicare patients who received IV iron products between 2013 and 2018. Patients who had received IV iron within the previous year and those with end-stage renal disease, HIV infection, history of anaphylactic reaction, or recent transfusions were excluded.

This is the perfect study for observational data. We know it happens so we look at a large data set and try to see how often it happens.

In this population of older adults, the rate of anaphylaxis for iron dextran was ≈0.1%, but it was closer to 0.01% for iron sucrose, ferric gluconate, and ferric carboxymaltose (can give once== carboxy and dextran). As indications have broadened for use of IV iron in managing various clinical conditions (e.g., heart failure, chronic kidney disease) when iron deficiency is present, clinicians might use these data to inform selection of a preparation.

A lot depends on cost and availability but these are good numbers to have in your head for the anaphylaxis event rate

...

Sure it might take 5 years or even 10 years but some of the outcomes like MI and HF will easily hit in the first 5-10 years!! This RCT could be done tomorrow! Instead we continue to do this observational studies and say look how great this procedure is!! Well maybe it is ‘healthy’ patient bias—you have two pts with BMI of 40 but one seems motivated is working out eating better- trying to take all the right steps and the other hasn’t left the couch in 6 years. The one that is active then gets referred for bariatric surgery and when we match them up we say LOOK AT THIS THE BARIATRIC SURGERY person did so much better. WEEELLLLLL that pt was likely going to do better anyways!!! AT this point everyone know that bariatric surgery seems to have great CV outcomes in retrospective and prospective observational trials we have done enough of them.. THIS analysis had 39 STUDIES—39!!!! We don’t need 30 more we need and RCT!!!

Katz PO et al. ACG clinical guideline for the diagnosis and management of gastroesophageal reflux disease. Am J Gastroenterol 2022 Jan; 117:27. (https://doi.org/10.14309/ajg.0000000000001538. opens in new tab)

Much of this guideline is worthwhile for nongastroenterologists.

An empirical 8-week trial of a proton-pump inhibitor (PPI), given once daily, is recommended for a patient who has classic heartburn and regurgitation but no alarm symptoms.

• PPIs should be taken 30 to 60 minutes before a meal, because they bind to proton pumps that have been stimulated by meals. Bedtime dosing is discouraged because this is less effective than a predinner dose in acid control
• GERD is thought to contribute to various extraesophageal symptoms, including chronic cough, hoarseness, and laryngitis; however, a causal relation often is unclear in any given patient. For patients with extraesophageal symptoms — but no heartburn or regurgitation — the authors argue against empirical PPI therapy

• After 8 weeks you STOP the PPI--PPI nonresponders, and PPI responders whose symptoms return after an 8-week PPI course, should be evaluated with Endoscopy about 2 to 4 weeks off PPIs. If endoscopy is normal, ambulatory pH monitoring (off treatment) is the next step.

authors encourage intermittent or “on-demand” (rather than indefinite) PPI therapy in patients with no history of high-grade esophagitis or Barrett esophagus. IF requires ongoing PPI therapy for symptom control should use the lowest effective dose.

I do like these guidelines cause they seem to be great at making sure PPI are stopped (ideally). I do hate these guidelines cause getting a scope after 8 weeks of a PPI with reoccurring symptoms seems like a lot of scopes will be done. Especially because some people get rebound gerd when going off of a PPI. As the authors state “One area of controversy relates to abrupt PPI discontinuation and potential rebound acid hypersecretion, resulting in increased reflux symptoms. Although rebound acid hypersecretion has been demonstrated to occur in healthy controls, strong evidence for an increase in symptoms after abrupt PPI withdrawal is lacking.” -- none of this is super strong evidence!!! This seems like a lot of scopes.

1. The fear of progression to adenocarcinoma with Barrett’s Esophagus would make for an easy decision for prolonged PPI use, however, a systematic review and meta-analysis published in PLoS One - Hu Q, Sun TT, Hong J, et al. Proton Pump Inhibitors Do Not Reduce the Risk of Esophageal Adenocarcinoma in Patients with Barrett's Esophagus: A Systematic Review and Meta-Analysis. PLoS One 2017;12(1):e0169691. https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0169691

found no protective effect.1

And even though long term use of PPI is associated with many bad outcomes even the authors state - “””“PPIs are the most effective medical treatment for GERD. Some medical studies have identified an association between the long-term use of PPIs and the development of numerous adverse conditions including intestinal infections, pneumonia, stomach cancer, osteoporosis-related bone fractures, chronic kidney disease, deficiencies of certain vitamins and minerals, heart attacks, strokes, dementia, and early death. “” the authors go on to say “””Those studies have flaws, are not considered definitive, and do not establish a cause-and-effect relationship between PPIs and the adverse conditions. High-quality studies have found that PPIs do not significantly increase the risk of any of these conditions except intestinal infections. .””” THIS IS ALSO GARBAGE!!! The reason the high quality studies don’t show this is because most studies are only 8-12 weeks long PPI you need long term trials which most people are on and you have to power your study so large to find a super rare outcome that observational data is the best we are ever going to have for this particular finding. I know the authors knew this but it didn’t fit their agenda…

Which is my last point—although we will never know—all but one of the authors has or is taking big pharma money.

Take home if you are following the guideslines-- start PPI only for Gerd like symptoms. Make sure taking the PPI correctly. Stop after 8 weeks. If it reoccurs then 2-4 weeks later off the PPI they need a scope and if the scope is normal then they need PH monitoring. Then the rec is for PRN PPI.