Gerdobserver said...
Hi,
Sorry for a long-winding post. Here’s a quick intro: 27-year-old male from Mumbai, India. Gerd since two and a half years. Small hiatal hernia. Sufferer of frequent reflux, regurgitation, chest pains and burping issues.
I recently posted about how a Delhi-based hospital had started doing the Endostim procedure. I had a word with the surgeon who does it. Below were answers to a few questions I asked him, and then, my case for and against it. Would love to hear from contributors on suggestions and what side of the fence they would be when it comes to Endostim.
- What's the latest in US trials/possible FDA approval?
Trials are on but approval may be long way off considering the time FDA takes to approve new procedures.
- Mechanism of action.
Low-frequency impulses imparted to the weak LES from a device located in an abdominal pocket via leads to goad it into closing (similar to the way cardiac pacemakers deliver impulses to make the heart beat). These impulses will be delivered for a few minutes a few times each day and studies have found these are enough to keep the LES closed. Later the device can be programmed externally to tweak its functioning depending on individual case.
- Implant procedure
The device will be put in a subcutaneous pocket near the belly button while leads will be fastened onto the LES. A few keyhole ports will need to be created for lead implantation while a larger 4-5cm will be created to implant the matchbox-size device. Entire procedure may take an hour or so. Patient will be discharged next day.
- Improvement in post-implant GERD indicators?
Recovery is quick and patients have been shown in studies to do about as well as in a Nissen.
- Life of battery/device/lead?
The device will be removed and replaced every 12 years via a minor local-anesthesia procedure at the end of the expected battery life. Leads are expected to last for life.
- If for some reason the leads will also need to be removed along with the device (especially after years of scar tissue buildup) will it involve a similar procedure as in cardiac pacemakers i.e. sheaths, etc, and is it expected to be as risky?
The doc said he expects lead removal for Endostim leads to be easier compared to those in cardiac pacemakers where the docs do not have access to the entire course of the lead (inside the chest cavity) and have to “blindly tug” at them while here they can removed easily point to point (Paraphrasing the explanation, could be wrong).
- Immediate post-operative care: diet, exercise resumption, etc?
Some diet restrictions required for a few days. Will need to be off strenuous activities, which can be restarted in a few months.
- Long-term precautions: exercise, activities that create abdominal pressure (lifting, cycling, swimming, running)?
Said does not foresee much need for long-term lifestyle medication. Forgot to ask him if one would need a certificate to clear airport security/metal detectors and if one can undergo MRIs.
My view:
Cons:
- The biggest risk being a fairly new procedure, no one really knows what to expect from the procedure over the long term. Since the device is expected to be implanted for life, what if the LES becomes increasingly dependent on the device to function, or worse, starts requiring ever-increasing dosages of electrical impulses to continue to keep working properly over the years (similar to how many become 100% dependant on cardiac pacemakers)?
- Another key risk could arise from the device implantation which could lead to not only typical issues such as site infection, etc, but considering it is located in the fairly delicate gastrointestinal region, it could be more prone to injuries from external sources and would be under more stress from even routine activities such as bending, stretching, lifting, etc (unlike cardiac pacemakers which I understand are placed inside the safer chest cavity and secured by the rib cage).
This could also add to the risk from the leads, which could get entangled, twisted, broken or potentially damage other vital organs in the stomach area.
- Expectations bias: Because I am inclined to consider doing the procedure given how badly I want to get rid of Gerd (and how I want to stay away from the fundo), I might not be able to neutrally judge the procedure in terms of its risk-reward ratio due to emotional biases. So most new procedures (think Stretta) would tend to be equally promising as this one till one gives it a few years and realize there were issues one could not think of at the outset.
Pros:
- Looks a step in the right direction by way of its functioning as the LES function is also actually controlled by neurostimulation by the brain. Here, the device simply takes over the job.
- Considering cardiac pacemakers have been around for decades, one could say risks of black swans (say consequences of long-term external electrical impulses to an organ) are relatively lower.
- Any new advances in pacemaker technology (St Jude launched leadless pacemakers last month) could be directly incorporated here. Who knows, when the time the replacement comes a decade from now, docs could remove the leads and put in a capsule or small coin sized device directly at the LES junction.
- Needless to say, no anatomical changes to stomach structure and far less trauma to the stomach, prima facie.
Your views welcome.
Hi Gerdobserver,
We are also from India, our 13 year old daughter had come down with LPR :( I am looking at various options to solve her problem...and came across Endostim. Just curious did you go for this surgery ? How did it turn out to be.....your post is from 2013, so thinking if you took it it must be 3 years now....hows everything going for you ?
Any side effects? Thanks for your help.
Mita