Heart Team Recommends Protected PCI vs. Medical Management for Treatment of 3VD After Surgical Turn Down

March 16, 2016

Today’s case review comes from the University of Washington’s Dr. Ravi Hira, who presents a ProtectedPCI case involving three-vessel intervention. Dr. Hira is Assistant Professor and Director of the Acute Cardiac Catheterization Service at Harborview Medical Center. His case involves the complete revascularization of a patient, who was successfully released from the hospital in relatively short length of stay without any complications. Listen to the interventional cardiology decision-making process involved in this case and subscribe to be emailed future case reviews.

Transcript:

Dr. Bilazarian: Hi, I'm Seth Bilazarian on ProtectedPCI.com. I'm delighted to have Dr. Ravi Hira from University of Washington. He's Assistant Professor and Director of the Acute Cardiac Catheterization Service at Harborview Medical Center. And he has been very kind to offer a case review that he recently did of a ProtectedPCI case. Ravi, thanks for joining us and tell us about your patient.

Dr. Hira: Thanks for having me, Seth. I guess people should be able to see my slides. So, basically we had a 50-year-old gentleman that had come to us as a referral after he'd presented to another local hospital with shortness of breath. He was diagnosed with heart failure with reduced EF, with a 15% EF, and he underwent cardiac catheterization there.

I'm going to show you some angios. So, this is the angiogram of the left coronary. He had LAD disease which was pretty critical, had diffused circ disease. And going to the right coronary, he did have a CTO of his proximal right coronary artery.

And he was referred to us for LVAD/transplant evaluation or evaluation from our surgeons for a bypass surgery. And the surgeons basically turned him down for bypassing, that his EF's too low and he has a poor LAD target. He was continuing to have worsening angina and worsening renal function, so the heart failure transplant docs optimized his inotropes and tried to see if we had anything that we could offer him for his triple-vessel disease. And that's when we started talking about revascularizing him with the help of Impella mainly because his EF was low and he had triple-vessel disease, including a CTO of his right coronary artery that we thought needed atherectomy once we got it open.

Dr. Bilazarian: So, let me just ask briefly, Ravi, so we talk a lot about heart teams and we talk really about revascularization as a heart team evaluation between surgical evaluation and PCI. Here's a patient who's really been turned down for surgery, so it's almost a heart team discussion between PCI and heart failure service with regard to LVAD or transplant. Is that the way it happened, with a really heart team approach, or really it was sort of kicked around in a sort of way of...

Dr. Hira: You're absolutely right. I think one of our highest referrers is our surgeons. With all these patients that are referred to us for heart failure transplant evaluation, a lot of them have triple-vessel disease that, in the community, people felt were not revascularizable or not candidates for revasc because they have diffuse disease. And frankly, people are concerned about their outcomes quite a bit, and because of that, they don't want to take on risk at times. So they refer to our heart failures folks who then consult with surgery, consult with us, and we do whatever we think is best for a particular patient. It does end up being a team approach. Our surgeons are great. Every time we have an issue where we do need them to back us up, they're there for us.

But with the way valve disease kind of evolved and with TAVR evaluation, MitraClip evaluation, how we get surgeons involved, we have a very similar evaluation for patients that have triple-vessel disease and ischemic cardiomyopathy to see what would be best for a particular patient. We have done some procedures which are hybrid where they get a LIMA and then we'll revasc the circ and the RCA percutaneously. As you know with the venous grafts, I think stents might actually be comparable there. And for these patients, now that we have devices that can support them hemodynamically, I think we're able to take on more and more patients with high complex disease which are with multiple core morbidities who would benefit from heart change revascularization if they're not candidates for bypass surgery.

Dr. Bilazarian: So, this patient is really in a really sort of a rapid descent in terms of his clinical performance. He's being either offered VAD or revascularization. You obviously offered revascularization. So what's your PCI plan? You and the fellow or other attendees who's going to take this case on, what was your approach to the patient pre-procedure?

Dr. Hira: First, I should say that I'm not an expert at CTOs. I work with Bill Lombardi, who's our Director of Complex Percutaneous Revascularization here. And he basically...we went over the angiograms, and we talked about doing complete revasc. There was some debate initially about how we were going to hemodynamically support him and whether that was absolutely necessary. Our thought is that in patients that do have triple-vessel disease that have low EF, they would have met criteria to be involved in PROTECT II anyway. This gentleman, because of his CTO and the need for atherectomy, again, a more complex procedure, we decided that that was one more reason to consider further hemodynamic support, and his renal function worsening was something we were worried about.

So we checked an EDP. His EDP was actually 25. His MAPs were in the low 90s at the time of evaluation. And based on these criteria, we decided that we should have hemodynamic support, and we chose Impella mainly because I don't think a balloon pump would have supported him enough and the Impella is something that we use fairly routinely now. We did, I think, eight or nine cases with that last week.

As we see more and more complex disease, I think what we've realized is there are several times where you think you can get away with something and take the risk, but unfortunately it's not us that's taking the risk. It's the patient that's taking the risk, and I think if it were my parent, I would feel most comfortable knowing that I did what was ideal for them in terms of getting them through the procedure safely.

I also think that it gives us a chance to work on complete revasc, and times when, for example, you would have stented the LAD and the circ because they're a little bit easier and given up on his RCA CTO, I think at that point in time, maybe we would have considered not using hemodynamic support. Because we wanted to go for complete revasc and do an atherectomy of his RCA once we got across it, I think that's why we decided to proceed with the hemodynamic support.

Dr. Bilazarian: Thank you for that. As much as these technical aspects you're going to show us now are really interesting, I think the really hard part of interventional cardiology is the decision-making, so I really appreciate those comments you made and the way you processed and thought about how to best both support the patient and make decisions about best treatment. So, take us through what you did.

Dr. Hira: Sure. So the angiograms here on the left are the diagnostics just to remind you of what the anatomy was. So we started by getting access. We usually, I think as a lot of people would do, get access on the left side for an Impella with the 14 French sheath. The plan is to take the Impella out at the end of the case. Because of a CTO, we usually get dual access, which is right-sided 8 French sheath for extra support and a radial 6 French sheath. So these are pictures of just the interventions on the LAD. As you can see, because of his renal issues, we were trying to conserve on contrast, so we actually direct-stented his LAD. This is a picture of that. This is a picture of revascularizing his circ. Again, a diagnostic image on the left, and the revascularization on the right.

So this is the dual injection from the right coronary and the left coronary artery. And as you can see, it's not a long CTO. It's fairly short, but it is something that, I think, if you had a patient like this who had triple-vessel disease, you have two catheters doing a dual injection, you realize that it might be more of challenge. And as you can see, there's a mild amount of disease there that does need atherectomy as well.

So we proceeded with a microcatheter and just aggressive wire escalation and went to a Pilot 200, which actually crossed fairly easily. And this is the final result of the case.

And after that, at the end of the case, we actually were able to ween him off the Impella and take it out. We used Perclose for all our accesses, so we did Perclose him on the left. And then we follow a sequence. I'm not sure what...every lab is a little bit different. We usually will take out the left access first so that we still had access in the right femoral and the right radial in case, for whatever reason, there's a complication in that groin, it's easier to deal with it. And then same with the right femoral, we take that out second. We still have radial access in case we need to build in tamponade or use a jomed stent or something to prevent complications.

And so at the end of the case, he basically had all three taken out. He was stable, had no angina after that, and his urine output actually got better and bumped significantly after that. He was discharged home after that. His heart failure symptoms definitely improved. And he's following up with our heart failure clinic now, and he's on medical management, if not gone down further, considering LVAD or heart transplant at this point in time. We have not reevaluated his EF yet, but I think we'll see what it shows and we go from there.

Dr. Bilazarian: So this is really a remarkable technical achievement, three-vessel intervention, successfully leaving the hospital in relatively short length of stay without any complications, specifically renal complications. But really for me, the impressive part is obviously your center's renowned for excellent expertise in complex coronary intervention, but the decision-making about taking a patient, even having an interaction with the heart failure team, I think in many centers it's been my experience that the heart failure service isn't sort of sensitive to thinking about revascularization as an option to help patients at least make some recovery, maybe not a complete recovery, but some recovery. This is really a phenomenal case, so Ravi, thank you for sharing it with us.

Any other comments about how you can encourage other centers to be more collaborative? Do you find that this is something that is grown up naturally, or do people have to be in a culture where this collaboration exists?

Dr. Hira: I think that's a great point, Seth. So I trained at a program where at times that didn't happen, and even here, before I came I was told that that had not happened traditionally. And I think the way medicine and surgery and heart failure have traditionally been brought up essentially is the way of silos, right. You focus on your area, and a lot of times it ends up being our heart failure colleagues that are interpreting angiograms as cardiologists and deciding on what is actually doable and what's not. And there's been significant evolution and development in the field of interventional cardiology where now we're able to tackle more complex disease and have hemodynamic support to be able to do that.

And at times I find that some of the prior generations of heart failure cardiologists may not be aware of these things being available to them, and that's fine. They're focused on heart failure and the should be. I think...

Dr. Bilazarian: They may not actually believe that there's a reasonable likelihood that in some patient subpopulations that they can actually have a meaningful improvement even with successful outcomes. I think your comment was, "Could it be done?" but, "Is it worth being done?" I think, is another question that they struggle with. So thanks you again for joining us Ravi. And until next time I'm Seth Bilazarian on ProtectedPCI.com.

Dr. Hira: Thank you.

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Impella® Device — Indication & Safety Information

INDICATIONS FOR USE

Protected PCI

The Impella 2.5® and Impella CP® Systems are temporary (≤ 6 hours) ventricular support devices indicated for use during high-risk percutaneous coronary interventions (PCI) performed in elective or urgent, hemodynamically stable patients with severe coronary artery disease, when a heart team, including a cardiac surgeon, has determined high-risk PCI is the appropriate therapeutic option. Use of the Impella 2.5 and Impella CP Systems in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri- and post-procedural adverse events.

Cardiogenic Shock

The Impella 2.5®, Impella CP®, Impella 5.0®, and Impella LD® Catheters, in conjunction with the Automated Impella Controller (collectively, “Impella® System Therapy”), are temporary ventricular support devices intended for short term use (≤ 4 days for the Impella 2.5 and Impella CP, and ≤ 6 days for the Impella 5.0, and Impella LD) and indicated for the treatment of ongoing cardiogenic shock that occurs immediately (< 48 hours) following acute myocardial infarction or open heart surgery or in the setting of cardiomyopathy, including peripartum cardiomyopathy, or myocarditis as a result of isolated left ventricular failure that is not responsive to optimal medical management and conventional treatment measures (including volume loading and use of pressors and inotropes, with or without IABP). The intent of Impella System Therapy is to reduce ventricular work and to provide the circulatory support necessary to allow heart recovery and early assessment of residual myocardial function.

Important Risk Information for Impella devices

CONTRAINDICATIONS

The Impella 2.5, Impella CP, Impella 5.0 and Impella LD are contraindicated for use with patients experiencing any of the following conditions: Mural thrombus in the left ventricle; Presence of a mechanical aortic valve or heart constrictive device; Aortic valve stenosis/calcification (equivalent to an orifice area of 0.6 cm2 or less); Moderate to severe aortic insufficiency (echocardiographic assessment graded as ≥ +2); Severe peripheral arterial disease precluding placement of the Impella System; Significant right heart failure*; Combined cardiorespiratory failure*; Presence of an Atrial or Ventricular Septal Defect (including post-infarct VSD)*; Left ventricular rupture*; Cardiac tamponade*

* This condition is a contraindication for the cardiogenic shock indication only.

POTENTIAL ADVERSE EVENTS

Acute renal dysfunction, Aortic valve injury, Bleeding, Cardiogenic shock, Cerebral vascular accident/Stroke, Death, Hemolysis, Limb ischemia, Myocardial infarction, Renal failure, Thrombocytopenia and Vascular injury

In addition to the risks above, there are other WARNINGS and PRECAUTIONS associated with Impella devices. Visit http://www.abiomed.com/important-safety-information to learn more.

Right-Side Support – Indication & Safety Info.

INDICATIONS FOR USE

The Impella RP® System is indicated for providing temporary right ventricular support for up to 14 days in patients with a body surface area ≥1.5 m2, who develop acute right heart failure or decompensation following left ventricular assist device implantation, myocardial infarction, heart transplant, or open-heart surgery.

Important Risk Information for Impella RP

CONTRAINDICATIONS

The Impella RP System is contraindicated for patients with the following conditions: Disorders of the pulmonary artery wall that would preclude placement or correct positioning of the Impella RP device. Mechanical valves, severe valvular stenosis or valvular regurgitation of the tricuspid or pulmonary valve. Mural thrombus of the right atrium or vena cava. Anatomic conditions precluding insertion of the pump. Presence of a vena cava filter or caval interruption device, unless there is clear access from the femoral vein to the right atrium that is large enough to accommodate a 22 Fr catheter.

POTENTIAL ADVERSE EVENTS

The potential adverse effects (eg, complications) associated with the use of the Impella RP System: Arrhythmia, Atrial fibrillation, Bleeding, Cardiac tamponade, Cardiogenic shock, Death, Device malfunction, Hemolysis, Hepatic failure, Insertion site infection, Perforation, Phlegmasia cerulea dolens (a severe form of deep venous thrombosis), Pulmonary valve insufficiency, Respiratory dysfunction, Sepsis, Thrombocytopenia, Thrombotic vascular (non-central nervous system) complication, Tricuspid valve injury, Vascular injury, Venous thrombosis, Ventricular fibrillation and/or tachycardia.

In addition to the risks above, there are other WARNINGS and PRECAUTIONS associated with Impella RP®. Visit http://www.abiomed.com/impella/impella-rp to learn more.

General Indication and Safety Information

To learn more about the Impella platform of heart pumps, including important risk and safety information associated with the use of the devices, please visit: www.protectedpci.com/indications-use-safety-information/

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