From PlasmaBlade to Dermabond in 20 minutes, flat.
Replacing my implantable cardioverter-defibrillator.
When I went into surgery last week, I wanted to document in detail the experience of getting an implantable cardioverter-defibrillator (ICD) generator replaced. I asked for light sedation and spent my recovery time typing up these notes while the experience was fresh on my mind. My hope is to have an open discussion about device therapy, inspire other patients to take an active role in their care and bring a little more transparency to health care.
This was a generator change or “gen change” as it is commonly referred to in Cardiac Rhythm. A generator change is a routine procedure where an ICD (or pacemaker) with a depleted battery is replaced by a new one. My original device lasted for eight years and three months, exceeding my expectations for longevity. It was implanted on November 19, 2007, and explanted on February 10, 2016. The outpatient procedure was fast, painless, efficiently done, and as patient-centric as I believe possible within an HMO setting like Kaiser Permanente.
I made an effort to engage as much as possible in order to exert some control over the patient experience. I shared my values and goals with the care team and tried to find a cardiac electrophysiologist whose philosophy was compatible with mine. It paid off. The doctor and his team were great, and he made a sincere effort to accommodate my requests, resulting in a pleasant and successful experience for me.
What went well:
- Most people I met were friendly, well prepared and knew what to do.
- The doctor listened to me and made an effort to address my requests.
- I got the brand and model of device of my preference.
- The procedure was fast and painless.
- Recovery from anesthesia was fast and there were no complications.
What didn’t go so well:
- I got a few push backs without good reason.
- I could not get copies of my device reports and some tests.
- The fast-moving pace in pre-op was uncomfortably fast and stressful.
- The overall experience discouraged engagement.
- My old device was not returned to me.
If you care about the surgical minutiae and a complete, detailed account of the entire experience, continue reading.
Selecting the brand and model.
I did my homework in preparation for surgery. I read up on the different brands and models of ICDs, improvements in longevity, advancements in technology and made a decision about which model and configuration I would like to get. Given that transparency is very important to me, I also visited the manufacturer’s web site to check for the availability of technical manuals, performance reports, clinical evidence, and other information to help me in my decision.
I also visited the Manufacturer and User Facility Device Experience Database (MAUDE), an FDA database that houses medical device reports submitted to the agency to get a sense of the types of reports of device-associated deaths, serious injuries and malfunctions for the model of my choice.
My values and goals.
After settling on the device, I spent some time thinking about what mattered to me and my expectations for surgery. I then put together a brief document, inspired by e-Patient Dave deBronkart’s excellent request for proposal for a skin cancer procedure published a few years ago.
I included my top three values, a short list of goals, and a list of requests to discuss with the doctor and others in my care team. I included these:
Values:
- Participatory medicine: having a voice in all decisions that affect my health
- Less is more: minimizing harm and avoiding unnecessary interventions
- Patient-centered care: having a care team that respects my wishes, preferences, and values
Goals:
- Prevent infection
- Maintain lead integrity
- Avoid inappropriate shocks
Picking a doctor.
My next step was to look for a cardiac electrophysiologist I liked and trusted. I met the doctor who would do my procedure at a patient conference where he gave a talk on device therapy. I liked his style right away. He was confident and knowledgeable, yet humble and caring, qualities I admire in a physician. His web site also said that he believed his job included educating and empowering patients so that they could be intimately involved in their own care. I was sold.
During Q&A, a patient asked if his wife could be harmed if she touched him at the same time he was being shocked by his ICD. The doctor answered that this was unlikely and explained that he had the habit of placing a hand on his patients during a defibrillation threshold test (DFT).
A DFT test is a procedure where a sedated patient is shocked to verify the ICD’s ability to detect and stop a dangerous arrhythmia. Instead of yelling “clear,” this guy actually got closer and touched his patient. This gesture, which I interpret as a sign of kindness and consideration, made a big impression on me.
I got his business card and asked the clinic for a referral.
Preparation for surgery.
In the days leading to surgery, I was instructed to get labs, a urine test, and electrocardiogram (ECG). Kaiser Permanente can be an efficient and well-oiled machine, albeit quite impersonal at times. Getting the labs done was fast and easy, and by the time I got home, the results had already been published to the patient portal. I was impressed.
Unfortunately, the experience at the Kaiser Permanente Oakland ECG lab was exactly the opposite. After the technician printed the recording on the classic red ECG paper, I asked her for a copy.
She denied it to me, expressing her concern that without the expertise of a trained physician I might misinterpret the results of the ECG causing unnecessary anxiety to myself. She insisted that only the physician report would be available to me, not the tracing itself, and only after a doctor had reviewed it and I made a formal request to medical records. She cited HIPAA as the reason why, and added: “The ECG is normal anyway. Why would you want a copy of a normal test?”
Clearly, the technician is in need of some training. Under HIPAA, patients do have the right to access their health information. No provider can lawfully deny a patient access to his own health information without risking getting in trouble with the Office for Civil Rights, the Health and Human Services Department office responsible for enforcing HIPAA. Finally, I know too well that my ECGs aren’t normal. I have hypertrophic cardiomyopathy (HCM) and left ventricular hypertrophy, and my baseline ECG is known to show T-wave abnormalities.
This attitude discourages engagement and forces patients into taking a passive role in their own care.
This is a classic example of a health care system that’s overly concerned with procedure at the expense of common sense. This attitude discourages engagement and forces patients into taking a passive role in their own care.
Surgery day: payment and consent.
I arrived at the Cardiac Procedures Unit at Kaiser Permanente Santa Clara Homestead at around 10:15 am. I checked in and was asked to pay a $400 portion of my $2,250 out-of-pocket dues. “We will bill you for the difference,” said the clerk.
The informed consent document was entirely electronic and was combined with a statement of financial responsibility for services rendered (you can view it here). I remembered a time when the consent to medical care and a contract for financial responsibility were separate documents. Not so in today’s world. The informed consent also included my permission to the taking of photographs and the use of such images by the hospital.
I remembered a time when the consent to medical care and a contract for financial responsibility were separate documents.
Since the document was in electronic format and I had only been shown a laminated sample of what I would sign, I wondered what would happen if I asked to strike out an unacceptable clause. The clerk advised that I could not amend the document directly, but that any comments could be noted in my chart.
I was given a hard copy of the signed version and told to take a seat in the waiting room.
The pre/post-op unit.
There were likely two dozen people in the waiting room, presumably patients and their families. Within about ten minutes a nurse with a clipboard in hand came for me. As I said goodbye to my spouse, she walked me to a large pre/post-op unit with about a dozen beds separated by privacy curtains. Pairs of feet in red socks were everywhere.
I was shown an empty gurney and ordered to take off my clothes. “Keep your underwear on, we don’t want to see anything,” one nurse insisted. I was given plastic bags and told to put my belongings in the bags.
I was also given my very own pair of red socks with treads on both sides. The curtains were drawn and I was left to undress while a squirrely nurse kept peeking in to see if I was done. The way everyone bustled around the unit, in addition to my already high level of anxiety kept my heart going at 100 bpm.
A male nurse walked in, introduced himself and said he was there to get me ready for the procedure. He brought in a portable stand-on scale, weighed me, then asked me to lie down in order to hook me up to a monitor.
I asked if it would be possible to ask someone in the procedure room to take a photo during surgery for me to share online.
I asked if it would be possible to ask someone in the procedure room to take a photo during surgery for me to share online. He explained that it would not be possible since the area was sterile and phones weren’t allowed in there. I couldn’t help to think how his answer sounded like a fib, since I had just signed a form giving permission for the taking of photographs.
The second I was ready in my one-size-fits-all backless hospital gown, the curtains were drawn and a swarm of people rushed in with needles, oxygen sensors, blood pressure cuffs and more forms for me to sign. One of the forms was an MRI screening questionnaire that asked me to record the existence of all metals in my body. I told the nurse that I only had the one ICD and the two leads they already knew about. Plus, I didn’t intend to have an MRI and didn’t think the form was necessary. The nurse explained that I would be in close proximity to a magnetic resonance scanner and that they wanted to make sure I’d be safe.
The first attempt to start an IV line failed. A small nurse with uneasy hands blew my “good vein” and after poking around with the needle for what it seemed like an eternity, she decided to give up and bring in another nurse to get the job done. The second nurse succeeded in placing the IV on the back of my left hand.
Another challenge was completing the MRI questionnaire while attached to an oxygen sensor, a blood pressure cuff squeezing my arm, a nurse finishing the IV and another nurse waiting for the form. It almost seemed like an absurd test of dexterity. A better patient experience would have been to have me complete all forms while in the waiting room.
Up until this point everything was hasty and I felt like a racing car driver going through a ten-second pit stop for refueling, new tires, and the scrubbing of my front grill.
It felt like a production line and I wished I had been better prepared for the breakneck pace.
The Physician Assistant.
A Physician Assistant I met once over the phone arrived bringing a ICD programmer to interrogate my soon-to-be-explanted device. She asked if I had taken my morning medication and wanted to know the last time I received “therapy” from my device. In the world of cardiac rhythm, this is the classic euphemism for the word “shock.” I handed her the report I had brought with me, which included the dates and times of all therapies delivered by my ICD.
She then warned me that she would be testing the pacing threshold of my implanted leads. I liked that she mentioned the test before performing it. After eight years of such tests, I still find the tugging caused by exceedingly fast ventricular pacing a bit hard to endure. Finally, the PA printed out the old device’s parameters in order to program the new ICD exactly as the old one.
This was something I deemed very important. ICD therapy had worked well for me, and I wanted to keep it that way.
I didn’t bother to ask her for a copy of the report since I had already done a full interrogation in my garage that same morning. She didn’t offer it either. This is not uncommon. Cardiac rhythm clinicians don’t typically volunteer copies of interrogation reports, or encourage patients to learn from such reports.
There is also no thought given to the fact that once an implantable cardiac electronic device is removed and disposed of, all of its data is lost forever.
In my case, not one provider has a complete data set that goes back eight years, not Kaiser, not my previous provider, not even the manufacturer of my device, which collects patient data over remote monitoring.
Each provider has some of the data, but no one has all of it. I am the only one with a complete set, and the only one who can answer questions like:
- Are my atrial arrhythmias becoming more or less frequent?
- What are the dates of my treated episodes of ventricular tachycardia?
- Is caffeine a trigger for my ventricular arrhythmias?
The doctor.
As the PA explained what to expect during the procedure, the doctor arrived. I was pleased. He greeted me, asked how I felt, and if I had recently experienced any fevers or chills. He also explained that the procedure would likely last for about an hour. He confirmed the device brand and model I would get (the one of my choice), and said that everything would be done with minimal conscious sedation per my request.
In preparation for this day, I had previously emailed him my preference for device model, questions about the prevention of pocket infection and concerns with maintaining the integrity of my leads and avoiding inappropriate shocks.
I had also brought along the original procedure report from 2007, which I had saved in my files. (You can view it here.) I handed it to him. He seemed interested in reading it.
“Make sure that the PlasmaBlade is sharp,” I joked.
“Make sure that the PlasmaBlade is sharp,” I joked. The doctor replied, “I will. We may even break out a new one for you,” he joked back. We all laughed. A PlasmaBlade is a unique surgical instrument used for dissecting soft tissue. In addition to causing minimal thermal injury to adjacent tissue, a key benefit of the PlasmaBlade is reducing the potential for damage to the silicone and polyurethane insulation of an ICD lead.
In light of my concern with maintaining the integrity of my leads (lead replacement surgery can be complex and dangerous), the doctor had explained that he routinely uses the PlasmaBlade as opposed to the traditional Bovie cautery device during generator replacements.
Getting my old generator back.
Once the doctor left, I went over a few last things with the Physician Assistant. I made sure she knew I wanted the old generator returned to me. She said that it was not their practice and that the old device would have to be retrieved by the manufacturer’s Clinical Specialist (CS) present during the procedure in order for it to be returned to the company for testing.
In order to have my old implant returned to me, I would have to contact the manufacturer directly.
The PA’s comment made me wonder how they may handle a scenario where the CS present in the EP lab is employed by a different manufacturer than the device being explanted. Kaiser Permanente, for example, has a dual-vendor contract with two ICD manufacturers. They alternate the two vendors on a biweekly cycle. (Dual-vendor agreements are common practice in health care to keep costs low.) Would they give a Medtronic device to a CS employed by Boston Scientific? I think not.
This, and the fact that there are at least five brands of implantable defibrillators in the U.S., makes it quite possible that the CS in the EP lab may not work for the same manufacturer of the device being explanted.
Finally, I personally have over a dozen live ICDs in my collection. So, for providers to say that all devices must be returned to the manufacturer is a bit hard to believe.
One last thing I wanted to ask the PA was to make sure there wouldn’t be out-of-network providers in the room. I had heard horror stories of patients who were billed thousands of dollars in surprise charges that involved out-of-network providers. “Do not worry. It’s just us,” she said.
A friendly nurse walked in, handed me a disposable light blue bouffant cap and I was wheeled into the EP lab.
Finally, the EP lab.
“Can you get me the PlasmaBlade? It’s way in the back,” a woman said in a Filipino accent as I was being wheeled into the EP lab. I knew it was on.
The windowless room looked darker than I expected. The lab was busy with medical equipment of all sizes, computer screens, ceiling mounted tubes and wires everywhere. The walls were of an unexciting tan color, almost dingy looking. There were faint alarm sounds everywhere and the constant humming noise of equipment fans.
According to my estimation, it took about four people about 20 minutes to get me prepped for surgery. They cleaned my chest, added defibrillator pads to my torso and moved me from the gurney to a thin surgical table. A sweet and caring nurse carefully tucked my arms and placed tight clear acrylic toboggan armguards on both sides. I was then strapped to the table with wide velcro belts.
Timeout and surgery.
The doctor walked in, greeted me, and explained that we were getting started. He asked the others in the room to gather for a “timeout”. It was hard to tell exactly, but I believe there were about six people in the room including the doctor, a nurse anesthetist, and the Clinical Specialist (CS) from the ICD manufacturer. As the doctor waited to get everyone’s attention, he told me that they always did a timeout before a surgical procedure to make sure they had the right person and the correct procedure. “It’s important,” he said.
Once everyone was ready, he asked me to state my name and date of birth. He pointed out that the name and DOB matched the patient information displayed on two large computer screens above my feet. He continued: “We are going to do a defibrillator generator change, operating on the left side of the chest, under conscious sedation.” And added that I would be given Fentanyl and Lidocaine, and no Versed per my request (a great decision that allowed me to keep a crisp memory to write this report).
“We are going to do a defibrillator generator change, operating on the left side of the chest, under conscious sedation.”
Lidocaine was used to numb the tissue around the incision and provide local pain relief. Fentanyl, a narcotic analgesic, was administered intravenously to relieve pain. And Versed, a psychoactive drug that causes short-term memory loss, was not used per my request.
“Anybody else?” the doctor asked. A female voice announced that the MRI forms were signed, and read from somewhere that I had no allergies. A man who had been manning an instrument table also announced that the equipment and medication on the table was accurately labeled for my safety. Finally one last nurse spoke up and reminded us all that I had promised to remain quiet. We all laughed.
The doctor said “Let’s start with 50 of Fentanyl.” A voice in the background repeated the order before carrying it out, “50 of Fentanyl!” Another voice said “make sure the external defibrillator is on,” referring to the Automatic External Defibrillator (AED). It felt like a close-knit team.
“Let’s start with 50 of Fentanyl.”
They removed my glasses, placed an oxygen mask on my face and covered my head with a surgical towel. They kept checking on me to see how I was doing. The same voice who asked for AED to be checked, started announcing my blood pressure numbers, heart and respiration rate to the team. She did that periodically.
“Hugo, you’re going to feel a little sting from the Lidocaine,” said the doctor.
PlasmaBlade at 6 and 6.
It took them 20 minutes from incision to final suture. All right, I am not sure it took 20 minutes, but I can tell you that the procedure felt really fast, likely under 30 minutes.
I heard someone say in the background, “PlasmaBlade at 6 and 6!” I had watched a YouTube video that showed Dr. Christopher Ellis, Cardiac Electrophysiologist at Vanderbilt, demonstrate the safe and effective use of a PlasmaBlade and knew what to expect. In the video, he mentions it’s recommended to set the tool at 6 and 6. I felt the urge to mention that I knew that, but controlled myself.
I heard someone say in the background, “PlasmaBlade at 6 and 6!”
The faint audible tone of the active PlasmaBlade was followed by cutting and sucking sounds. The noises made me curious to see how they were doing, whether or not they were using the same incision, and if they could already see the leads.
“Are you doing OK, Hugo?” asked the doctor. I responded affirmatively.
There was some major pushing and tugging and a voice announced “device is out of pocket!” Someone repeated, “device is out. Disconnect.”
I heard the loud metal on metal clang of my old, faithful ICD dropping into a surgical tray. We had been together for over eight years. It had done its job well.
I heard the loud metal on metal clang of my old, faithful ICD dropping into a surgical tray. We had been together for eight years. It had done its job well.
“Testing the wires”, someone said. “Rs are 16, 5.30, 5.20, 5.50… pacing threshold is good. Checking the atrial lead now.”
“Hugo,” said the doctor, “this is going to feel cold. We’re washing the pocket.” I loved how he kept me informed at every step of the way.
The doctor then asked for the new device. A voice, presumably the manufacturer’s CS, announced the full model name and its expiration date. The doctor turned to me and said, “this one has tapered edges. You may find it more comfortable than your previous one.”
He then instructed someone to start connecting the cables. “Pace/sense first,” he said. Each of his instructions were followed by the characteristic clicking sound of a torque wrench being turned to tighten the setscrews. “Click, click, click…”
“Hugo, your new device is connected. We’re placing it in the pocket now.” More tugging and heavy pushing and someone announced, “device is in the pocket!”
The doctor explained that they were closing up the incision with absorbable sutures for the inner layer and Dermabond for the outer layer of my skin. Dermabond is a type of sterile, liquid skin adhesive used to close certain types of incisions. After I’ve seen so many sloppy suturing jobs, including the use of lock-stitch sutures for pacemaker incisions, I was definitely pleased he was using glue.
Great choice of doctor, I thought to myself.
As he finished closing the final layer, my new device was being programmed from afar. I heard the CS read the old ICD settings to a nurse: “Lower rate, 50 to 130. MVP, AAI, DDD. VF at 200, VT at 167.”
“Same settings, right?” she said. “Same settings,” the CS replied.
As they wheeled me out of the EP lab, the CS walked along pairing my newly implanted ICD to a brand-new home monitor. “Stop for a moment,” he said to the nurse pushing the gurney. “He’s getting out of range.”
And just like that, I was done.
