Complications After PFO Device Closure Surgery?

Hi,
My name is Ashutosh, am one of those whose feeling terrible after ASD closure through the amplatzer device. I have terrible migraines that i never had before the closure. I do beleive it is because of the device. I did reach out to Dr Jamil via email , but was able to gain little information from him. He seemed most kind though. Unfortunately ive not been able to meet him as i live in India. Could you please give me any more information as to what he said about the nickel , i am planning on having my device explanted quite soon,

Thanks

Hi Ashutosh,

I am sorry about the migraines that have started up… Is that your only
symptoms post closing the pfo?

An American nickel has about 30% nickel in it. Take a shower and then
clean a nickel really well ( with alcohol wipes and soap and water too)
than take a sterile bandage and tape it to your freshly showered and dried
forearm.

Keep it there for 24 hours, remove it and see if there is any signs of
allergy or inflammation in general ( redness, itching, swelling).

I am actually doing the test now pre procedure lol.

Besides the migraines there are a lot of small ancillary things, like you dont feel too good after oversleeping and other small things, but the migraiens are the main one . Ive done a skin patch test as well as a prick test. The prick test did show a reaction. Katherine hasnt really replied to me , dont think shes on the group anymore. I would advise a MELISA test to completely ascertain whehter you have a nickel allergy or not. Wish i coulda met Dr Jamil, if you dont mind me asking what else he told you ?

Hi, i am really taken aback to learn that doctors have no solution to the pain and breathlessness. And they let go patients . The alternate is device removal and ohs. Omg. What a situation to be in.

I found this chat while looking into a possible allergy to the Gore Helix device I have. I know you posted this two years ago, but I wanted to know what you found out. Thanks

Hi Katherine, my name is Ashley. I had an ASD transcath procedure about 3 days ago. I feel exactly the way you did. It feels like a chicken bone is stuck in my throat. I deal with 2 cardiologist one in Buffalo, NY and one in New York, NY. They seem to think the nickel allergy is a myth because most nickel allergies occur on your skin not the tissue, but I firmly believe it is definitely a possibility. One of my cardiologist suggested that I might have a sensitivity or allergy to the aspirin or plavix they put me on. However, I’ve taken aspirin in the past and never felt like this. It doesn’t seem to be getting better. It’s hard to take a deep breath and it hurts to cough. I read you post and said that’s exactly how I feel. My hole was 22mm, unfortunately I went a year ago to get it closed and the gore helex device wasn’t big enough. So I had to wait for the next generation gore helex that is supposed to be used for bigger holes. I did some research and I knew that I did not want the amplatzer device because of the possible nickel reaction. The doctors made it seem like this was a sure thing, but I’ve never felt this terrible in my life. I was actually considered a “case study” for this new device and now I’m having second thoughts about keeping it in. You said you felt like that 11 months later, I cannot live if I feel this way. Did you ever find out what the reasoning was behind feeling how you did? I hope you are better now, I know your post was a couple years ago.

Katherine, did you get your device explanted?

How are you feeling? I just read your post from a few months ago. The nickel allergy is very real. I had full on, crack my chest, open heart surgery in September of 2017. I had the Gore Helix device since April of 2009. Eight plus years of hell. So many medical complications caused by the allergy. I was never told anything about nickel. I had been looking for answers for at least 5-6 years before I found out the problem. I did an at home nickel test, which was positive. I then saw an allergy specialist who did confirm the allergy through two different tests. Saw a new cardiologist in a different office from the one who put it in. He took it out ten days after my first appointment. I live in Utah. There were a few doctors who were putting dozens of these things in weekly. National average for implant was around 2,000. The doctors had an average of over 10,000! I believe it was over a five year period. Have you been tested for nickel allergies? There were some people who tried to tell me a 24 hour urine test was the only thing to detect the allergy. Not true. I had two skin surface tests.
Take care and I hope to hear from you soon.

Hi Carrie
Just wondering if you made a full recovery after getting your device removed? I also had mine removed with no improvement. I am having a surgical screw taken out of my foot next week as it has nickel in it. Hoping for a miracle.

Katherine, I wanted to thank you for your post. My brother found this forum and had read your story and called me, saying “you have to read this - this is exactly like what you’re going through”. Your experience with your surgeon sounds almost identical to mine, and I was so struck by some very specific parallels that I had to write. I was diagnosed with an ASD early this year at the age of 50, with no specific cardiac symptoms having manifested (except for potentially the extreme insomnia I’ve had for past 4 years w/3 subsequent years of various unsuccessful attempts at treating the severe sleep apnea that was diagnosed, eventually progressing to right heart enlargement which lead to the ASD finding). Because the intravenous ASD closure was “minimally invasive”, and because I had so many preliminary workups (starting w/the basic echo that found the shunt, then a T.E.E., then a transcranial doppler, then a heart cath), I stupidly let the young surgeon’s overabundance of self confidence prevent me from having my lifelong hypersensitivity/allergy to metal jewelry keep me from holding everything until I had my allergy medically confirmed. At every preliminary workup I mentioned, “I keep reading about two frequent complications after closure with the Amplatzer Septal Occluder: chronic A-fib, and allergic reactions. I’ve never been able to wear metal jewelry - I’m pretty sure I’m allergic to several metals.” EVERY TIME, without fail, the surgeon just dismissively said, “You wear jeans don’t you? If you can wear jeans, you’re not allergic to metal.” I always responded with, “But I wear underwear - in fact I wear boxer briefs that cover everywhere the various rivets and buttons on jeans could make contact with my skin.” Well, fast forward to after the ASD closure . I immediately had complications. I went into A-fib (for the first time in my life) during the surgery, and two days later developed a huge swollen lymph node in my left armpit (the size of half a tennis ball). 2nd day home it was back to the E.R. in the middle of the night. The surgeon eventually agrees to see me again and says, “You must’ve been predisposed to A-fib. As for the lymph node, that could be anything…”. Fourteen days after surgery I developed severe giant hives from head to toe, which grew into welts, and the ones in the palms of my hands itched so badly I couldn’t stand it. Back to the E.R. at 3am one Sunday, subsequently back to the cardiologist later that week. After 9 solid days of debilitating hives/welts that became only moderately more bearable while continuing high does Prednisone for them, I pushed to the cardiologist’s office to get him to see me again to discuss the complications (after he’d dismissively insisted I go see my primary care dr, and I had done so, only to have my primary dr tell me “this clearly is the result of something related to your surgery”). Upon entering the room, before I can speak the surgeon blurts out, “I’m going to talk, and you’re going to listen.” He then immediately proceeded to berate me for being a “difficult patient” (perhaps because he’s unequipped to deal appropriately with any indication of anxiety coming from his patients who are experiencing debilitating complications which he is directly responsible for - complications that he’d repeatedly insisted were “statistically insignificant” before they actually were happening in front of him?) and he immediately proceeded to completely flip out and angrily quit my case, even canceling an outpatient surgery that I was scheduled to have with him just two weeks later (to implant a subcutaneous LINQ monitor to track this new Afib - which he’d concluded was absolutely necessary the day after my ASD closure and my second day in Afib). This is the same surgeon who had claimed to have gone out of his way to push the insurance company to cover the procedure (in the absence of a prior stroke) during all the preliminary workups, who now - at the first sign of complications - put on a big show of angrily quitting my case and distancing himself from it as aggressively as possible. I had been struck by the fact that the cath lab nurses had commented to me (while prepping me in the procedure room the day of my closure) that the device company rep had come all the way there to observe the procedure. I remember asking, “If they’ve implanted over 200,000 of these things, why would they send a company rep to observe my procedure several states away from where they’re located?”. The answer I was given was, “Oh they come to every ASO device procedure to observe.” That had struck me as really strange. Then when I read about your cardiologist - who had been so helpful prior to any post-surgical complications - pulling the same exact routine of quitting your case at the first signs of trouble - I couldn’t help but think there’s something more going on here. Perhaps the device company advises high volume implant surgeons to distance themselves from the cases where certain complications show up, or perhaps this surgeon is just a really arrogant asshole who has no business being a surgeon. Either way, I’m now in the process (thanks to reading everything you wrote) of documenting the metal allergy (I just had the patch test done last week which indicated a strong allergy to titanium and vanadium; I was unable to find a source for the MELISA test, but probably it’s unnecessary at this point with a strong positive on the patch test). I saw a new cardiologist (unfortunately one in the same office/practice as the surgeon who did my closure but one who is older and more experienced, although he does not claim any experience with doing ASO implants or explants) two weeks ago, and he immediately outfitted me with a Zio surface-adhering A-fib monitor for two weeks to try to determine the next steps for the A-fib, and he indicated if explant is required he would refer me to a minimally invasive thoracic surgeon in the region, outside of their hospital system, who could handle my case for the explant and surgical closure…). So, I only wish I had found this forum before I had allowed this surgeon to pressure me to ignore all my concerns and listen to his boasts of having done “over 300 of these procedures without complications” and that I had trusted my gut instinct and researched the Amplatzer Septal Occluder even more thoroughly and over more time. The Netflix documentary, “The Bleeding Edge” recently came out and so much was brought to light in that which I can obviously attest to now but had no idea was the case beforehand regarding the medical device implant industry. One thing worth noting is that the makers of that documentary did a good job of discussing the DaVinci robotically assisted surgery’s very serious issues, and in light of what they showed, if (when) I have to have an explant procedure and conventional surgical correction of my ASD, I would work very hard to find an experienced minimally invasive thoracic surgeon who could do the surgery without using the DaVinci, or one who has done so many of them that their proficiency wouldn’t be in question. Thank you for all the info you shared - I just want to get my life and my health back, and to caution anyone who’s been told they need to have percutaneous ASD closure via an implanted device to BE CERTAIN YOU ARE NOT ALLERGIC TO METALS before undergoing the procedure. Incidentally, I reached out to St. Jude’s/Abbott (the device manufacturer), referencing my device’s specific serial number, hoping to learn EXACTLY what the metal makeup of my device is (in light of the positive test results for titanium allergy AFTER implantation had been completed), and their response was “Speak with a cardiologist. No detailed information regarding the composition of the Amplatzer device can be sent out externally.” THIS is their response even when given the exact serial number of my device and the information that I’ve just confirmed a strong titanium allergy following post-implantation complications and was simply seeking any info to help best guide my medical decisions moving forward. They wouldn’t even provide any basic info/data regarding incidence of allergic adaptation vs. need for explantation. Isn’t it great to know that the device manufacturers are so concerned for patients’ well-being once they’ve sold their devices? I’ve had better customer service from basic household appliance manufacturers… - Sky C.

Hello Katherine,

Thanks for sharing information about Melisa test. Hope you have recovered completely now. My daughter is scheduled for cardiac cath on June 12th. They are planning to put either Cardioform by Goretex or Amplatzer. I want to understand about MELISA test. I understand you are allergic to material in the device. Did the Melisa test gave right result in your case? How is the accuracy of this test?

Thank you so much for sharing all the details. I will look forward to hearing from you.

Hi Fay. I had an Amplatzer Occluder (106493) put in my chest in Nov. 2011 (47 years of age). I was told the reason mine settled in so well is because of my fitness regimen. I was doing wind sprints on the beach in Jacksonville, FL when I went into a porta-john four miles into a six mile run and had a massive stroke. I walked, after I picked myself up a couple of times, back to my truck and drove home. I showered (thoroughly!) and headed to the hospital, slurred speech and all. My stroke was triggered by a right kidney engulfed in cancer and when it chunked, it passed through the hole in my heart and shifted into the left ventricle with the oxygenated blood, settling in my brain. The occluder was put in on day 7 in the hospital, the kidney taken out a couple of days later. Six weeks later, I was out of the hospital, and at seven months, back at full fitness. I was told by my cardiologists and primary cares that my fitness regimen is largely responsible for the success I’m having with it. I keep wondering to this day if it’s ever going to “jiggle loose” or shift for some reason. Over the last year (maybe less), sometimes when working out, I get a nasty stabbing sensation in my chest. I really hurts but only lasts for a few seconds, then goes. It’s not been steady nor predictable and thankfully, sparse. I can go weeks without it happening but sometimes a few days in a row, it will. I wish you well in your progress and hopefully, I can get my career back on track so I too can enjoy what so far has been a successful operation (seven years as of 11/18). I refused chemo and jumped off Coumadin/Warfarin within days after my stroke. So far, so good. My suggestion to you (“Finally Mike!”) is make it a point to exercise at least two hours a day if you can, with an intense cardio routine at the core and yoga and/or weight training to supplement it. I run 7.5 miles 5-6 days a week and follow it with weights and/or yoga (depending on the day). My surgeon credited the success of my implant to that. Make the time to exercise any way you can. Best wishes Fay!

These stories have made for some interesting reading and very helpful as I go into year 2 of my PFO Closure. Over the last few weeks I have experienced many sensations such as numbness in my left arm, tingles or pokes throughout my entire body and pain in my chest around my heart. They seem to be stronger after a heavy cardio or high exercise/activity day and seem to be most common when I lay down for the evening. I often now wake up at least once per night with these symptoms and its difficult to fall back asleep. I am very concerned as to what it happening and feel strongly that this is related to the closure. Anyone else have such symptoms or sensations?

Before they closed my PFO, they wrapped a Nickle coin to my arm. If it showed any allergy, they would not be able to use the device.

In CA, contact Dr. Press (Cardiologist) and Dr. Tobias (PFO Cardiologist) at UCLA.
They have seen shortness of breath and PFOs. Me!

Also, PFOs can cause inflammation in our digestive tracks. My stomach has enlarged, pushed my Diaphragm up into my lung collapsing the bottom half. Additionally, my other Diaphragm has paralysis and very shallow contractions. Dr. Ross (no longer at UCLA -Pulmonologist) had ran a ct of my abdomen and a ultrasound sniff test.

I have/had everyone of you symptoms in the last year except the nickel allergy. My arteries also random spasm before and after my PFO closure in March.

Having the PFO for 46 years undiagnosed… many of my organs are suffering from lack of clean oxygenated blood.

Hi @troycelynn I also am experiencing exact symptoms as you I had my closure in 2019( ASD ) I recently saw Neuro and PCP as my cardiologist said they can’t see anything physiologically wrong with my heart. I am now on heartburn medicine ( which I’m still having chest pain with) An antidepressant for “anxiety “ I honestly feel concerned that the device might be causing these symptoms. Have you experienced any improvements ?!

Providing an update here. I have now gone a while, maybe 3.5 years now without those tingling sensations. I continue to monitor it and I see my cardiologist annually and I continue to exercise.