This is a nice case and a problem that is seen not too uncommonly. I have also seen this in patients with upper arm basilic vein outflow from an access where the basilic vein has multiple branches and one of them gets occluded or partially occluded with thrombus during the procedure. Sometimes the clot cannot be removed despite much effort.
In this situation, I would have gone through the central veins with a large balloon (at least, 14 mm) to make certain that there was a good channel back to the right atrium. The thrombus is likely caught in the pacer leads or (as Loay Salman has shown) where the leads tether to the central veins. Now, comes the issue of blood flow. If there is good blood flow through the access, this thrombus should not matter. I am not certain I would have used any more than procedural anticoagulation. The thrombus will likely resolve or embolize with good access blood flows. Now, comes the issue of reserve. If this patient has little reserve to overcome a small pulmonary embolus, then, maybe, systemic anticoagulation may help (although, I do not think there is any literature here).
All of our patients are sick. If this patient had not had the central thrombus during the procedure, you would likely have had no concerns about performing the procedure in the outpatient center. My usual requirement is that the patient can lie flat (or, close to it) and is not septic. This is because most patients will stay in the hospital for days to get even the simplest procedures performed.
As far as stenting, we have all used stents to trap resistant thrombus. Of thrombus is trapped in an outflow vein, the vein is likely quite diseased although such irregularities are difficult to see on the angiography. Stenting across pacer leads is a problem. If the pacer leads become infected, how are they removed? There is some anecdotal literature about pulling the leads past the stent (i.e., a covered stent should be placed). Placing a central stent across pacer leads needs to be decided on a patient-by-patient basis. I had a patient who was dying with a central stenosis due to pacer leads that had caused a swollen arm. The patient would not have tolerated removal of the pacemaker. The dialysis unit was having issues with the patient's access due to the edema. A stent cleared the edema rapidly although it was placed across pacer leads (angioplasty alone had not worked). The patient did well with dialysis until dying about six months later. This was the right treatment for this patient.

Once again, I am supposed to be asleep, but cannot resist trotting out my petty prejudices and poor critical reasoning skills.
(1) normally we would not place a shunt of any type in patients with an EF less than 20%, for fear of increasing their risk of sudden cardiac death, and repeated thrombosis due to poor flow in the shunt. These patients might be better served by a catheter that does not place a burden on the heart when it is not being used (providing that it does not get infected, and evolve into an episode of sepsis). We are slightly more permissive with fistulas, although we have also seen a very high number of high-flow "firehose" fistulas that aren't tolerated well either. I don't know of any literature on risk of death or repeated thrombosis with low EF - I am just being intuitive.
(2) since it well known that the combination of a pacemaker and ipsilateral AV shunt leads to significant venous hypertension (mostly arm swelling) about 70% of the time, I also question the placement of a graft below a pacemaker. This problem is predictable, and potentially avoidable. The pacemaker was there first - you cannot blame the cardiologist.
(3) having seen many patients become unstable in my 1400 percutaneous thrombectomies, I no longer do these procedures outside a fully equipped hospital. I know that makes me a rarity, but a wrongful death suit changes your priorities;
(4) re-anticoagulation - there is a role. We put everybody on antiplatelet agents, and selected patients on anticoagulants. I would not hesitate to put this patient on anticoagulants despite a remote history of GIB, with ulcer prophylaxis of course. I have also seen a thrombus like this resolve completely with a 12-18 hour TPA infusion (must admit to stepdown unit usually);
(5) no stent over wires - sorry. The clavicle moves constantly in relation to the first rib and erosion of the pacer lead insulation by the stent could cause loss of pacer function. In such a case, you compare the disability of a swollen arm to the consequence of pacer dysfunction. In Dr. Gabbard's case, a six month survival might reflect the time necessary for the metallic structure of the stent to rub through the insulation of the pacer lead.
(6) If Dr. Gabbard's patient is dying, why is s/he being dialyzed? I have had many patients stop dialysis, and die peacefully within a week. Sometimes the answer is to stop struggling.
It is late, and once again, the men are at the door to shut me up in my room for the night - ta ta!

Ok, a wealth of points here to discuss - and I have a different take on these issues. I’ll address the case and stenting at leads first, then will reply to the other comments later:

Going back to the original case, I suspect much of this lead associated clot will naturally lyse with restored blood flow in the access - but management will need to be planned in case it does not.

The trial of anticoagulation may be reasonable in appropriate patients - but every patient must be individually assessed for this. You don't want to assume the responsibility for a bleed here, and at the least you should touch base with the patient's nephrologist.  The Eliquis you gave may help with lysing the thrombus, and it will be interesting to see your follow-up imaging.  

Another option could be inpatient admission with TPA infusion -but again this does bring up anticoagulation risks.  Angiojet could be something to consider.

However; we have a potentially dangerous thrombus here - and a stent-graft may actually be the quickest, safest management.  This would entrap the clot against the leads and completely prevent any migration risk, embolism, or death.  This would be relatively easy and quick to do, as long as you have the appropriate sized stent-grafts (and you should have the appropriate stent-graft in your lab, should you ever rupture a central vein with angioplasty.)

Pulmonary hypertension is also prevalent in this population, and clot migration with the presence of a patent PFO could turn this into a significant stroke.

Of course the risk with stent-grafting here is lead entrapment - which should be avoided as possible.  Lead infections can happen, and when they do, we have a disaster with an entrapped lead. 


The key to the management decision here is to predict how stable this clot is.   Perhaps you can wait around with anticoagulation and everything else...  

But the clot made it this far centrally, who knows if it will migrate further?  Will it loosen up with anticoagulation and cause issues?  Will the existing leads act as a filter to prevent fatal large clot migration?  Will it harmlessly dissolve?  

Small thrombus fragments are generally of no concern, but this is fairly large thrombus in a large caliber vessel – which did not break up with angioplasty.

Even if you sent this patient to the ER immediately, theoretically this clot could fly off while the patient is en route.  

With these risks at play, I don’t believe we can just discount the choice to immediately stent-graft this and end the risk for embolism.  None of the entrapment/ infection/ lead erosion risks matter if this patient has a massive PE, and I may have been inclined to immediately stent- graft this thrombus.  This is just opinion based, and you have to weigh in all the risks and benefits here.



————————

I was a co-author on the multi-disciplinary paper below, and if you have not seen this - it’s worth a look:

http://c.ymcdn.com/sites/www.asdin.org/resource/resmgr/imported/CIED%20published%20paper.pdf


At the time, we advocated to avoid stunting over the leads as possible for stenosis - and advocated for the possibility of removing leads, then stunting, then replacing leads to avoid lead entrapment (this referred to cases of lead associated stenosis - we never entertained the thrombus issues in this case.)  However; this is not always feasible in our patients - and I have stent-grafted over leads in cases where no one was interested in the lead extraction or patients were too ill to undergo it. 

The last patient I did this on was in his 80s with debilitating arm edema after recurrent short-term PTA.  He refused the lead removal options, and did well a stent graft over the leads - I used a long 13x10 Viabahn for that case, which extended from the subclavian to the innominate/brachiocephalic vein.  There have been no 1st rib/ clavicle issues with this patient.  

I’ve had a handful of patients like this over the years, and all did remarkably well with stent-graft placement - with no lead dysfunction.  I've seen other cases where this has worked out as well.  But I want to emphasize that it is something to strongly avoid as much as possible. 

Here's a link to a presentation by our lead author on the paper above, with his fairly good experience with stents at leads – this is the best reference out there for this situation:

http://c.ymcdn.com/sites/www.asdin.org/resource/resmgr/imported/SAT%2016%20Saad%2020130201%20StentsCIEDLeadsASDIN2013.pdf

The last slide sums it up – one size does not fit all here…and I’ve better appreciated this over the years.

Again, avoid this as much as possible – but it may be feasible in very limited situations.

----------------------------



I would encourage all of you on this forum to develop a relationship with your local Electrophysiologists, as they may not be aware of the issues we frequently face.  

In our area, we have been successful in placing cardiac devices on the contra-lateral sides of an existing AV access, and we have mostly placed new AV accesses on contra-lateral sides of existing cardiac devices.  We’ve gotten our thoracic surgeons involved as well - and for suitable patients we have occasionally placed epicardial leads using a mini-thoracotomy. 

In cases where nothing is suitable on the contralateral side, we assess central venograms for patency at the subclavian and central veins at the leads - and have at times chosen to try for an access even in the face of occlusion, with the vigilance to ligate the access the face of significant edema and planning for a femoral access.  But sometimes it works out well, with established collaterals.

The advent of subcutaneous ICDs has been fantastic for our patients - and we’ve managed to mostly use them for patients who do not require pacing.  Our EP community has been very supportive.

—————————————

As far as doing interventions on the leads, it is safe to do - below is a link to the abstracts from a prior ASDIN meeting:

http://c.ymcdn.com/sites/www.asdin.org/resource/resmgr/imported/Abstracts%20for%20CD.pdf


On page 25, the group of University of Miami demonstrated how durable the leads are - basically no abnormalities to leads after 50 angioplasties on a bench model - with no signs of any deformity or erosion and maintained lead function.  

No one has looked at any data for stents/ stent-grafts and lead erosion - but in my small experience and anecdotal sharing of cases with others, more complaint stents-grafts have not caused an issue.  I’ve never heard of a bare metal stent eroding through a lead - but this is generally a rare scenario to be in anyway.  Given the durability of leads in the face of angioplasty, I’m not as concerned with the risks of lead damage from stents.  Infection and entrapment are still risks though.

I can't emphasize enough that this a scenario to avoid - but again, it may be feasible in limited situations.

This has become a very nice discussion.
I am still not certain that I would stent across the leads for the thrombus. It would have to depend on the functional status of the patient. I find that it is difficult to assess the amount of thrombus (and, sometimes, the degree of stenosis) from an angiographic image. Even when performing an open thrombectomy, I always expect there to be more thrombus. But, I agree with Dr. Patel that each case should be individualized. We have taken out several ICDs/pacemakers due to stenosis in the central veins. Of course, stenting was necessary after removal of the device. It is not the easiest procedure for the patient. And, getting some of the cardiologists to do it can also be difficult. Many would prefer the access be ligated than to remove the device.

Let’s go back to the immediate management scenario in the case presentation.

Regardless of the functional status of the patient – in the moment, you have to immediately decide if this will lead to a potentially fatal event or not.

I honestly can’t tell –and with the thrombus burden in this picture, I can appreciate that some may have a gut feeling that could go either way.

With lead associated stenosis, you have the ability to stop and reassess the entire situation. You can make an informed decision with the patient and discuss all of the issues.

However; with a potentially lethal clot at hand in the middle of a thrombectomy, you’ll have to make a quick decision while you are in the procedure room.


If we had double or triple the thrombus burden here, would we more inclined to stent-graft this? What if the entire subclavian vein was thrombosed? What if we watched this clot migrate further centrally during the case?

Should we never entertain the option of stent-grafting over the leads – even with a risk of death?

Would it be an easy decision to stent-graft this if there were no cardiac leads involved?

A PE (or stroke with a patent PFO) is the risk you take if your gut feeling is incorrect.

When fatal embolisms do occur with a thrombectomy, the scenarios are not too different than what we are dealing with here….

All this being considered; I think the patient will be just fine – with lysis of the thrombus with restored flow. But we need to consider all this issues at hand to safely do these procedures.

Great points from Drs. Patel and Gabbard - as usual.
Not to be fatalistic, but what is this patient's life expectancy?
Running around worrying about death - "death is coming".
All choices have risk. I would give a bolus of heparin, 8mg of TPA, and transfer the patient for a TPA drip and re-exam in the am before placing a stent

In my city, following my demand, the cardiologist are placing the wires via the internal jugular vein, with less risk for the subclavian vein!
Can Marc WEBB send me his mail? tpourchez@nordnet.fr

I like Dr. Webb's conservative approach. An angiojet would probably be the best option. I also agree with Dr. Patel.... There are instances when most of us would stent. If the SCV became completely occluded and could not be reliably re-cannalized, most of us would stent. The literature talking about pulling the leads passed a stent would mean that a covered stent would be the best option. Additionally, we should all remember that most patients have subclinical (or, sometimes, clinical) pulmonary emboli during a thrombectomy procedure. Would people treat this patient different if the thrombus were partially occluding a peripheral draining vein (and could not be removed with typical techniques)? I suspect in that case, most of us would place a covered stent right away.

American cardiologists seem to be single minded proceduralists. One boasted to me that he did 30 cardiac caths a day - how can you possibly do a quality job stretching yourself so thin? The answer is in the question.
At the May VASA meeting it was predicted that transvenous pacer wires would be a thing of the past in three years. My response, "Only if the payors quit paying for it". I have not succeeded in getting any cardiologist here to route a wire over the clavicle to spare the subclavian. One patient told me he was getting a pacer - "Don't let them put it on the same side'' I said. He came back in three months with an ipsilateral pacer and arm swelling. "Why?", I asked. "The cardiologist said it would not matter". I have had to dilate him over and over, gritting my teeth each time.
I did a proximalization for digital ischemia yesterday - he had a cardiac cath in the last six months using the radial artery - in the side with a dialysis access, in a diabetic with severe atherosclerosis, where the blood supply was radial dominant - and the fucking cardiologist has the nerve to say, "well, at least we are keeping you in business" ...... He drives a better car than I do. I suspect he has a cottage up north, and a condo in Sanibel.

I hate cardiologists
And orthopedic surgeons
And Insurance company CEOs
Did I mention divorce attorneys?

While I understand that your thoughts are often entered in the wee hours of a long day (which might explain the bluntness of your comments about cardiologists @Marc Webb), I broke into a huge grin and wanted to "high five" you as you expressed your frustrations with some of our interventional cardiologists. I know I've experienced many of these same issues. I actually attempted to discuss this but have been blown off by some of these same physicians.

I have even offered the old ASDIN white paper on this as well as a compelling explaination to no avail.

I fully appreciate the sometimes ugent need for a cardiac procedure. But I am accustomed to evaluating a patient's entire status before I do any procedure or sugery. How about the Pacer on the left, the SUBCLAVIAN line placed by a radiologist or non-access surgeon on the right, and the swollen arm for which we and the patient must deal with?

So hats off to you, sir!

Dr. Webb.... You made me laugh first thing in the morning. Cardiologists usually do not think. And, when you find one who will listen and converse, then you send that cardiologist all of your patients. In my area, the cardiologists like to use the cephalic arch to gain entry to place pacemakers. I had a patient with a new access that I had matured. He was about to have his catheter removed when the cardiologist destroyed the cephalic arch with an ICD. Luckily, I was able to turn a collateral vein into his venous outflow to the central veins. The cardiologist's answer as to why the ICD could not be placed on the right side: "there was a tunneled dialysis catheter there". One phone call could have alleviated that concern. The catheter was coming out anyway. The patient did need the ICD, he was having VTach during dialysis. ASDIN should set up a consortium with ACC to discuss these topics, and the best ways to care for our patients. The subcutaneous ICD has been a nice addition.

From my european point of view, the medical practice in USA seems a little more fragmented than here?
And the nephrologist ought to be the conductor of all the cares needed by his patients, to be sure they would be appropriate for them.
We ought to care our patients like if they were from our family.
Is that possible ?