[1] I really don’t have any disclosures. We participated in multi-center trials from essentially all manufacturers but I get no personal research for it. Todd, Dan said do what? Right? This one? Okay, okay. So, I’m at Mayo and this is one, maybe two interesting cases. And, shortly after I joined Mayo, I had been at the University of Iowa, I was told that the last thing you want to be is an interesting patient at the Mayo Clinic. So, anyway, I’m going to show you this and I‘ve got to give credit to our nurse, Amy Beeman, who without her, I couldn’t have done this procedure. Also, Joe Dearani who is the surgeon involved. [2] So, this is a 32-year-old female, corrected congenital heart disease, essentially a single ventricle, what’s called an unbalanced AV canal defect. She has had a number of operations including a Fontan. For those of you that haven’t dealt with Fontans, you’re lucky, but Fontans preclude venous access to the ventricle. In addition, we didn’t want to have access to the ventricle endocardially because the patient had only one ventricle, a systemic ventricle. She was very sick, severe LV hypoplasia, the morphology was RV dominant. The ventricular ejection fraction was 30%. She was listed as status 1B for a transplant. At a previous operation at another institution, had had an epicardial dual chamber pacemaker placed about six or so years prior. At that time, this was concurrent with one of her repairs. They were Medtronic unipolar leads placed on the atrium and on the one ventricle. It was attached to a Sigma device. Okay. [3] Skipped slide. [4] She did pretty well despite her advanced congenital heart disease but then had a very alarming episode of syncope, abrupt syncope preceded by palpitations, awoke spontaneously but this was very disconcerting to the people following her in the Adult Congenital Heart Disease Clinic. She was referred to us for consideration of an ICD because of her advanced heart disease and alarming syncope. Now, her Sigma device has limited electrogram storage, essentially no electrogram storage. It does detect high rate ventricular episodes. There was none detected. The detect rate was set at 180 so it may well be that she had an episode of VT below that rate but we did not have documentation of an arrhythmia but the history was quite alarming. Now, several problems stared us in the face right from the get go. First, as indicated, because of the Fontan, there was no venous access to the ventricle. Moreover, we didn’t want to get access to the ventricle because the only ventricle that she had was a systemic ventricle. The final thing is that Dr. Dearani, who is a very experienced congenital heart disease surgeon said, “I will not enter the pericardial space, this would be the fourth entry into her pericardial space. I’m going to do more damage than good. I’m gonna rip something. She’s tenuous. I’ll be happy to help you out but I’m not going to go into the pericardial space. Thank you very much.” So, we had to make do with what we had. So what we had [5] Skipped slide. [6] Skipped slide. [7] was this. I don’t think we have the house we have the house lights down a touch maybe. So, I deliberately overexposed this slide. This is the preoperative chest film. So, this is the pacemaker in the right upper quadrant, existing unipolar epicardial leads, atrial and ventricular. Again, on the lateral, here’s the atrial lead and the ventricular lead and the signal pulse generator in the right upper quadrant. [8] So, Dr. Dearani did a left anterolateral thoracotomy. And I’m going to walk you through this a couple of times, it gets kind of hard to follow but, so here’s what we did. And I’d be interested if you had thoughts on this. We placed a patch electrode extrapericardially. Essentially, it was placed just under the ribs but outside the pericardium and we tunneled that to the right upper quadrant pacemaker pocket. So, we combined that patch with the unipolar epicardial lead to form the RV or the ventricular component of the ICD. Now, we’re left with a unipolar atrial lead and this patient had AV block. We’re left with a unipolar atrial lead and we desperately want to pace this patient in the atrium which was tenuous as it is and I’ve got to credit our nurse on this one. So, we placed a coil electrode like you might put in for a single coil device or if you’re adding an SVC coil, we placed that subcutaneously in the left upper quadrant just under the muscle and we tunneled that to the right upper quadrant. [9] And then the question is, “How do we connect this stuff to make it work?” You wonder in these procedures and you think, “I’m being pretty smart her.” And then you kind of keep going, you go, “Maybe, I’m not so smart.” [10] So, here’s what we did and I’m going to go through this a couple of times because it is, to say the least, odd. This is the Medtronic patch electrode, again, just under the ribs but outside the pericardial space. This is the Medtronic coil. These are brought over to here. [11] And essentially, what we were creating is a “unipolar” pacing ICD. Now, as nature abhors a vacuum, electrons will not transport unipolarly. So, all devices are bipolar, it’s just, how big is the bipole? Electrons have to flow from one pole to another. So, a unipole is essentially just a very broad bipole. Now, in general, and some of you are I hope old enough to have dealt with pacemaker ICD interactions when we had separate devices, unipolar pacing is proscribed in ICDs for a couple of reasons. One is because of cross chamber counting, you can count the spikes as well as electrograms. There is more electromagnetic interference in unipolar sensing. Now, in ICDs, there are no true unipolar headers. Remember, a unipolar pacemaker is generally pacing between the tip electrode and the canister but there is no true unipolar headers in ICDs. So, at this point, we have a coil electrode that we want to couple to an atrial lead and we’ve got a patch electrode we’re gonna couple to a unipolar ventricular lead. So, we chose a Medtronic 7272, one of the earlier “InSync” devices and we did this purposely and we actually enlisted Medtronic’s help because in this device, unlike subsequent ones and I’ll make that a point for reason, sensing occurs between the tip of the RV lead and the coil of the ICD lead. And this connection between the RV tip and the RV coil occurs in the pulse generator. So, we took advantage of this by connecting the unipolar RV electrode here and the patch electrode there. The unipolar lead had an IS-1 connector. The epicardial patch was paced in an HVB port and again, the epicardial unipolar lead IS-1 connector was placed in the RV pace sense port. [12] I’m gonna show you the header hookup in a second. Now, we turn to the atrial lead. We took the atrial unipolar lead which was an IS-1 connector and we Y-adapted it with a subcutaneous coil to yield an effective bipolar IS-1 input to the atrial port. We plugged the LV port and plugged the SVC port. Now, just to go over [13] connectology again and I’ll do this one more time. So, here’s the HVB port, it comes down, excuse me, the patch to the HVB port, the subQ coil, atrial unipolar lead, Y-adapted, and the ventricular unipolar epicardial lead, Y-adapted, excuse me, plugged into the RV pace sense port. [14] So, here’s the CRT-D header in the 7272. So, we plugged the SVC coil port. The epicardial patch was placed in HVB. We plugged the LV pace sense. The epicardial unipolar V-pacing lead was placed in the RV and the Y-adapted atrial unipolar lead connected with the subQ coil was placed here. Now, the key point here is that in this device, pacing and sensing occurs between the RV tip electrode and the RV distal coil and the connection between these two occurs in the header. [15] And it worked. And we were happy to get out of the operating room. Pacing and sensing were adequate. There were no counting errors. Detection of VF was excellent. And defibrillation was effective to the extent that the surgeon would let us do it. [16] Now, unfortunately, two years later, she presents with premature battery depletion. Unclear mechanism. It was not a device failure. I suspect that it was related to high current output from the low impedance pacing system and she needed a pulse generator change. Now, the problem we faced here was that this device was no longer available. Medtronic was able to identify one in Switzerland on Thursday, we were doing the case on Friday. She came from some distance. The newer Medtronic ICDs have true bipolar sensing, that is RV tip to RV ring which didn’t help us out because we needed a sense and pace from RV tip to RV coil. Now, Guidant ICDs have integrated bipolar sensing, that is they pace and sense from the tip to the distal coil but this connection occurs in the lead, not the header. We already had leads in. So, the advantage of the 7272 was that the connection between the coil and the tip electrode occurred in the header. We’re stuck here because we don’t have a device that will work. [17] So, the problem was getting the epicardial patch connected to the ventricular unipolar lead for sensing and pacing. [18] So, what we did is we scared up a lead extender and this, a couple of things here, this is the lead extender, this is a typical Guidant triple-headed device but note here, there is only one set screw per lead. So, this is taking one pole from each input, converting it to an IS-1 and two DF-1s. [19] If you look, oh great, perfect, perfect, yeah, great, thanks. So, so, here, and many of you probably know this is that in the Guidant device, the DF-1 distal wire spits off a connector to the IS-1 lead for pacing and sensing. And you can sometimes see this on x-ray and sometimes radiologists call you up and say there’s something wrong with this. So, this extender and a Guidant ICD lead for that matter is effectively a Y adapter, from the distal coil, it sends one branch to the high voltage circuit and one branch to the low voltage circuit. [20] So, more connectology. So, the epicardial patch was placed in the DF-1 port in the adapter. The ventricular unipolar IS-1 connector was placed in the IS-1 port in the adapter. The second DF-1 port was plugged. The adapter IS-1 pin was placed in the pace sense port of the Guidant device. The DF-1 distal pin was placed in the negative shocking coil. The SVC coil was plugged. And the atrial lead worked as [21] previously. So, this is the Guidant header. Again, we plugged the SVC coil. This is the IS-1 for the atrium as before. This is the IS-1 pin from the adapter lead. And this is the DF-1 distal pin from the adapter. So, again, the point here is that in Guidant ICD systems, pacing and sensing occurs between the RV tip electrode and the RV distal coil. Unlike the 7272, the connection is in the lead, not in the header so we finessed this by using an adapter. [22] So, the take home message is, here, now nothing is impossible even a sort of unipolar ICD. You need to know connectology. You need the vagaries of different manufacturers’ hardware and I always refer to this with our fellows as this is Radio S knowledge, you need to know what’s on the shelf at Radio Shack and what you get off the shelf. And finally, good device nurses are a lot more important than good doctors and I’ve got to give credit to out nurse, Amy Beeman. [23] I don’t have time for one brief one or not? Warren? We could have some questions now folks, one way in, or I can show you one more unfortunately interesting case from the Mayo Clinic. Let me just whip through this next one because this one’s really weird. Okay, so case two. The smallest patient I’ve taken care of. Seven weeks old, 8.2 pounds. The patient found to have in utero two to one AV block. Despite all this, normal birth and delivery. Profound QT prolongation, I’ll show you the cardiogram, the longest QT we have seen and we have a large dedicated long QT syndrome clinic. Non-sustained Torsades at home in Milwaukee. The father was an ER physician. They managed to get a home AED. They carried it everywhere. The family was essentially paralyzed by concern over this kid. Family history completely negative. [24] This is the ECG. And the QT estimated by the computer was about 700 ms and, again, I showed this to Mike Ackerman who is our long QT specialist and he said this, in fact, it was his patient, this is the longest QT we have seen. We are in the process of genotyping this but we do not know the defect. I suspect it’s a sodium channel defect. So, he was referred for ICD implant in large part because we didn’t know exactly what his prognosis was and the family was literally paralyzed. [25] So, he was sent to me and I called up a surgeon, Dr. Dearani [26] again. And at Dr. Ackerman’s suggestion, in addition to the ICD, we did a sympathectomy and we placed a patch electrode outside the thorax, just under the serratus anterior and latissimus dorsi muscle, a very limited access to the heart with two epicardial screw-in leads and a right upper quadrant pulse generator. [27] This is the chest film. And sometimes we put ICDs in patients and sometimes we attach patients to ICDs. Now, I think this device weighs 60 grams or so. You know, this is a substantial percentage of this kid’s body weight. But this is the [28] AP chest film. This is the lateral. And interestingly in the OR, we could not induce arrhythmias whatsoever despite every trick we knew. [29] Again, it was a Medtronic ICD with screw-in epicardial leads. This was a small [30] patch electrode. It looks pretty big on him. [31] As of just about a month and a half ago, he is doing well, he is gaining weight. He has had no ICD shocks and genotyping of his defect is underway at the present time. So, I believe that’s it. If we have time, we’ll take any questions. Otherwise, we can move on. Thank you very much for your attention. [32]

Robert Rea 210B-ARS "Unipolar" Dual Chamber Pacing ICD Implant Tips and Tricks for Device Implantation