Patient (self) advocacy

Today I took the step of escalating my situation to the patient care quality board of my local hospital. I have expressed my concerns at the pacemaker clinic and I am not satisfied with their explanations. I'm attaching below the 'redacted' letter I wrote.

Everyone in this forum has been super supportive that a "2 out of 5" right ventricular lead is not acceptable and should be replaced. I am now 3 months post op and the pacemaker clinic's current position is that it does not warrant replacing. Without your support, I probably would not have written this letter. I have reached 'peak anxiety' over this. I am hopeful that my letter will result in an objective, 3rd party review of the situation and if not, at least I have made my concerns known, early on in this process.

Thoughts and comments are welcome!

---letter---

I am writing to request a patient care quality review of the above surgery I received at the XYZ Hospital on October 25, 2019. My understanding is that due to vein access and other complications encountered during the surgery, it was not possible to position the right ventricular lead to sense at the target 5 millivolts. Just before I was discharged, Dr. X disclosed that the lead was sensing at 4 millivolts, which he thought was acceptable and would only drain the battery slightly more than if it were at 5 millivolts.

As of my first visit to the Pacemaker Clinic on October 28, 2019, the right ventricular lead had slipped to 2 millivolts and has not improved since then. I have expressed my concerns at the Pacemaker Clinic that I am relatively young (56), have no underlying health concerns (the pacemaker is for swallow syncope, not a heart condition, per se) and that I do not feel confident that a right ventricular lead sensing at 2 millivolts will serve me for the rest of my life.

During my most recent visit at the Pacemaker Clinic on January 21, 2020, the RN explained that the Medtronic pacemaker is highly programmable and is currently set at a higher sensitivity to compensate for the low voltage of the lead. She also said that I am at the upper range of the programmable settings with only 2 additional settings remaining and that the criteria for replacing the lead would be that the pacemaker is on its last programmable setting. The pacemaker definitely meets my immediate needs and keeps me from passing out when I swallow.

From the research I have done, the risks of removing the lead increase over time because it becomes more and more embedded in the heart tissue. For this reason, I am very concerned about leaving it ‘as is’ for the longer term.

I am requesting a quality review by your office because I would like to know whether more could have been done, peri- or post-operatively to achieve a better outcome and if it is in my best interest to wait until it is absolutely necessary to replace the lead. Thank you in advance for considering my request.


6 Comments

My goodness!

by arentas80 - 2020-01-31 00:03:42

Everyone here supports you and we wish you nothing but the best outcome possible! Sending lots of support your way :-)

I Applaud You!

by Swangirl - 2020-01-31 01:03:27

Yours is an excellent example of how not to settle for poor medical care and to push on, using all avenues, to get what you should have.  The letter is unemotional, using facts and making a good argument for what needs to be done.  I certainly hope you succeed.  In this country (US), in case people don't know, we have Managed Care Boards in many states where people can make their complaints and ask for a review.  

My thoughts

by Gemita - 2020-01-31 05:55:26

Dear Sally,

Your letter is an honest account of what has occurred and well written but for me, and you did ask for our opinion, it fails to make an impact on what you need to get across.  If I were on the receiving end (i am in the UK), I would think “well this lady doesn’t have a heart condition, is relatively young and well, isn't getting any symptoms (syncope), so what is the real problem here?" We have to change that image and put across a stronger case for looking at their decision again, and doing what you want them to do, since I believe you are clearly not happy to leave the RV lead where it is ?

We need to express more positive points and not focus on “the reasons why they might be inclined to leave well alone”. I also wouldn’t focus too much on whether more could have been done peri and post operatively;  you need more focus on what you want to happen NOW - a repositioning before RV lead gets embedded and removal becomes more complex.  I have taken the liberty of rewriting some of your letter Sally in case this helps :-

"I am writing to request a patient care quality review of the above surgery I received at the XYZ Hospital on October 25, 2019. My understanding is that due to vein access and other complications encountered during the surgery, it was not possible to position the right ventricular lead to sense at the target 5 millivolts. Just before I was discharged, Dr. X disclosed that the lead was sensing at 4 millivolts, which he thought was acceptable and would only drain the battery slightly more than if it were at 5 millivolts.

At my first visit to the Pacemaker Clinic on October 28, 2019, I discovered, worryingly that the right ventricular lead had slipped to 2 millivolts and has not improved since then. I have expressed serious and valid concerns at the Pacemaker Clinic that I do not feel at all confident that a right ventricular lead sensing at only 2 millivolts will continue to serve me well in the future and that frequent checks and adjustments may not be enough to ensure that the device will continue to fully meet my requirements for which it was originally implanted.

I am more than aware that the risks of removing a lead increases over time because it becomes more and more embedded into the heart tissue thus making any corrective surgery more complex and lengthy.  I believe the earlier my RV lead position is corrected the better.  For this reason, I am not happy to leave the RV lead where it is and hope for the best.  I would like to respectfully ask your doctors to consider its immediate repositioning and/or replacement to give me the best possible chance of a successful outcome, to avoid any further lead complications, increased battery drainage and sensing problems that are likely to arise in the future. 

At my quality review I would also like the opportunity of discussing whether more could have been done pre/peri/post operatively to achieve a better outcome, so that when the RV lead re-positioning is attempted, this has the best possible chance of succeeding.  Clearly I have many unanswered questions and I believe these need to be urgently discussed.  Thank you in advance for considering my request for a review.  I look forward to your early response"

Thank you

by Pacemaker_Sally - 2020-01-31 11:54:24

Thank you everyone for your supportive comments so far and especially to Gemita for giving my letter more oomph! 

Should get it replaced

by webbonwa - 2020-01-31 22:50:55

I had a non-functioning lower lead. My doctor who put in the lead called me up one evening and told me that the lead was not working no matter what he tried to do with it and it had to be replaced or my pacemaker could stop. Eventually it was replaced but that operation is more difficult than the installation. There are more risks. See my write up about my own surgery. You need to be prepared for open heart surgery in case of a slip up and you need to make sure the surgeon has the new tool for removal of the lead.

Thank you

by Pacemaker_Sally - 2020-02-02 14:15:26

Thank you webbonwa. Please provide a link to your post? I couldn't find it. 
So far, I have not been able to influence the decision to leave the lead as is. It is 40% functional, not disfunctioning, but definitely underperforming. 
I also saw another post (by kathy_g?) that she is ok to wait for extraction technology to improve. My lead is brand new though and not yet embedded, so extracting it sooner has its advantages. 
I'm not hopeful that the quality review will change anything. But at least I have made my voice heard. 

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