Making the Right Choice When Choosing a Lead Extraction Sheath

Speaker: Bryon Lee, MD

Description: Dr Byron Lee, from the University of California San Francisco, discusses his research on efficacy and mortality of different lead extraction sheaths. He also describes the outcomes, how it has impacted his practice, and how this data can be used to improve patient care.

Sponsored by: Cook Medical 

Transcripts:

Byron Lee (00:10):

Hi, I am Byron Lee. I'm a cardiac electrophysiologist at UCSF.

Interviewer (00:17):

How long have you been performing lead extractions and how did you get started?

Byron Lee (00:22):

I started about 17 years ago at my institution. No one else was doing it and somebody had to do it, and I was the newest member of the faculty. And I actually had a little experience in fellowship, so I was the one who was asked to do it, and part of why it was me was because no one else wanted to do it. It carried a high mortality rate compared to the other procedures that we do, and so I ended up being the one.

Interviewer (00:50):

What led you to initially choose to use rotational sheaths in your practice?

Byron Lee (00:56):

So I actually started using the Bovie Sheath. At the time, as I mentioned, no one was doing lead extraction, and I looked at the Cook Bovie Sheath and also looked at the laser sheath option. And it turned out that using the laser sheaths was a bigger capital investment. And so since I was just starting out, I wanted to try it out with something that didn't require a big capital investment. It turned out the Bovie Sheath worked pretty well, and so that's the type of sheath that I used initially. Eventually, Cook, who make made the Bovie sheath came out with these rotational sheaths, and they had found great success with the rotational sheaths. They started pushing it as the primary option for extraction, and it turned out it did work really well, and that gained more popularity to the point that people were using the rotational sheaths primarily and skipping the Bovie Sheath altogether.

Interviewer (02:03):

You've performed interesting research on rotating sheaths versus laser. Can you talk about the findings of your recent meta-analysis on efficacy and mortality?

Byron Lee (02:14):

So I had been doing lead extraction by then about 10 years, and we had gotten excellent results with the rotating sheath. And so I asked around and started talking to other people, and they told me that they also had excellent results with the rotational sheath. No real major disasters with it, no tears of the SVC. And so I was interested in seeing if we could maybe get some proof that this might be a better modality. And so we undertook this research project. I did it with a fellow research fellow, Dr. Sun Lee, and what we did was we gathered up all the published consecutive case series using the rotating sheaths or using the laser, and we combined all the data from these papers and tried to answer the question, is the laser sheath better or the rotating sheath better when it comes to complete lead removal success? And also whether there was a true difference in danger or mortality.

(03:30):

And we found surprisingly that both sheaths did pretty well, but it turned out that the rotating sheath actually did better when it came to complete procedural success getting the entire lead out. And then the biggest surprise was the mortality difference. Turned out in the meta-analysis, we found that there was a 9.3 times increased risk of mortality using the laser sheath. So it verified what we started to think was the case, but we had no idea that the difference in mortality was going to be so great.

Interviewer (04:08):

In 2019, you published information from the MAUDE Database around mortality rates in lead extraction. What were those results?

Byron Lee (04:17):

So in that study, we were trying to come at this clinical question of which sheath is better in a different way. And so instead of looking at published case series, we decide to look at the MAUDE Database, which is data on American patients, U.S. patients who may or may not be included in these published case series. And in the MAUDE Database, companies like Cook who makes the rotating sheath or Spectranetics who makes the laser sheath and a rotating sheath, they're supposed to report any complications that they have with their product. And so we went into the MAUDE Database, looked at all the complications reported with the two types of sheaths, and we counted up the number of deaths associated with laser sheaths, the number of deaths associated with rotating sheaths. And then to get a risk of death, we needed to know how many cases with each sheath type were was done in the United States during the study years that we were interested in. And we were able to get estimates of that from market research.

(05:34):

So both Spectranetics and Cook are public or are companies that investors are interested in. And so there are market research firms that make estimates of how many cases in the United States are done with the laser sheath and how many cases are done with the rotating sheath. And with that, we were able to calculate a overall mortality rate with the two types of sheaths, and we found that the laser sheath was associated with a 7.2 times increased risk of mortality when compared to the rotating sheath. And the rotating sheath, either kind of rotating sheath, either the Spectranetics or the Cook product. And so it reinforced our finding that laser sheaths are just more dangerous, that they have more risk, that there's increased mortality with the laser sheath.

Interviewer (06:26):

How do you feel this data has been received? Have you heard from physicians who have been impacted or changed their practice as a result?

Byron Lee (06:35):

Well, the reception of our research has been mixed, and it seems to depend on what your practice entailed beforehand. The people who were already using rotational sheaths extensively received the research findings positively. Many of them said to me, "This is what I knew all along, that the rotational sheath was safer." And then people who use the laser sheath primarily, I think they were very skeptical. I think it's hard for them to break old habits. I don't think too many of them have abandoned using the laser sheath if they've been using it for many years. I do know that the research has led some laser sheath users to switch from the laser sheath to a rotational sheath earlier on in any given case.

(07:40):

I do know that laser users now are a little more cautious when they use the laser, especially when they're turning in the SVC because that's where the real danger is. The tears in the SVCs are really the cause of most of these deaths that we see with lead extraction. So I've heard that they are starting to be more cautious with the laser and sometimes avoiding using the laser in that region and sometimes going to the rotational sheaths when they're cutting in that region. My response would be to that, "Well, why bother with laser at all? Why don't you just use the rotational sheath from beginning to end? Why bother switching from laser to rotational sheath then back to laser?" That's been my approach and it's worked really, really well.

Interviewer (08:36):

Has the information changed how you approach lead extractions?

Byron Lee (08:42):

Well, it hasn't changed how I approach it. I've been using the rotational sheath primarily for a long time now and having really, really good success. And so it really hasn't changed what I do. It's given me more confidence in knowing that I'm offering the best possible approach for our patients. I think there was a concern at one point that because we didn't have the laser, are we selling our patients short? But now in retrospect, I feel confident that using the rotational sheath is the best approach and that using the rotational sheath, we're giving the best possible care to our patients.

Interviewer (09:26):

What other research is needed on lead extraction to further advance patient care and procedural outcomes?

Byron Lee (09:32):

So I have to acknowledge that our study or two studies were not randomized controlled trials. It's true indeed, that they had very strong results suggesting that the laser is much more dangerous. But I do think that to convincingly show that the rotational approach is better, it would require a randomized control study, patients enrolled and then randomized to either laser sheath or rotational sheath. I think that would prove it once and for all, which sheath is better and which sheath is safer. And I think it's important to do because if it turns out that indeed the laser sheath is more dangerous, which I think based on my research, then we're doing a real disservice to our patients, that mortality rate increase is significant. And if it's true, we should be avoiding the laser. So I'd love to be able to either be a part of a randomized controlled trial or see somebody do a randomized controlled trial to prove once and for all, which approach, which laser versus rotational sheath is superior.

Interviewer (10:56):

Thank you for your time today, Dr. Lee.

Byron Lee (10:59):

It's my pleasure.