High-Risk, Left-Main Intervention, with Impella Support. A Q&A Interview.
In the video case review below, Dr. Tom Earl, MD of McLaren Northern Michigan, Petoskey, MI and Abiomed, Inc.’s Vice President, Interventional Cardiology Programs Dr. Seth Bilazarian discuss Left-Main PCI with the Impella heart pump. Watch the video presentation and be sure to subscribe to be emailed future case reviews.
Dr. Bilazarian: Hi, I'm Dr. Seth Bilazarian on ProtectedPCI here with Dr. Tom Earl from McLaren in northern Michigan to present a case that he has of ProtectedPCI, and we're excited to have him share tips and tricks and what he learned. So thanks for joining us, Dr. Earl.
Dr. Earl: Thanks for having me, Dr. Bilazarian.
Dr. Bilazarian: So let's get right into your case, and then I'm excited to ask some questions at the end.
Dr. Earl: Sure. So I'd like to present a case a 74-year-old woman with no prior history of coronary artery disease. She is an insulin dependent diabetic who presented with chest pain and acute heart failure and did rule in for a non-ST-segment elevation MI. Diagnostic heart catheterization demonstrated severe calcified distal left main disease extending into the ostium of her LAD. She also had a high grade stenosis of a relatively small caliber right coronary artery.
After diagnostic angiography, myself, the surgeons, and the clinical cardiologist all got together and reviewed some of her pre-operative testing with the eye towards possible surgical revascularization. She was found to have significant underlying lung disease with markedly abnormal PFPs, which the surgeons thought that she was at prohibitively high risk for surgical revascularization. So after a discussion with all involved, including the patient, we elected to proceed with a high-risk complex PCI.
Dr. Bilazarian: Fantastic. So the patient's brought back subsequently, and what was the plan for intervention? Tell me a little bit about why Impella might play a role in this patient.
Dr. Earl: Correct. So she remained hospitalized. This took maybe four to eight hours to get the full preoperative workup and an evaluation with the surgeons. She remained stable in the hospital. We fine-tuned her medically a little bit with the idea of early Monday morning first case to go to work and get this opened up percutaneously. Given the left main disease, she did have mild to moderately reduced left ventricular systolic function.
The need up front, or the suspicion up front, that we'd have to do fairly extensive rotablation given the calcified disease, I thought this case was perfect for Impella. I remarked to one of my colleagues that I thought you probably shouldn't do this case without left ventricular support.
Dr. Bilazarian: So tell me a little bit about the approach. So basically did you do pre-procedure aortography and iliac angiography, or is that routine with your diagnostic?
Dr. Earl: Almost all my diagnostic work and most of my PCI is from the wrist, so I didn't have any data about her distal aorta or her ileal femoral vessels. So when we brought her back, that of course was a concern. We started with bilateral ileal femoral injections and they looked beautiful. Large caliber ileal femorals bilaterally with a distal abdominal aortogram that also showed some calcium in the distal aorta but no abluminal narrowing. So really we had good access through both groins.
Dr. Bilazarian: So procedure was done this time as a femoral procedure, or did you do radial angiography and Impella from the groin?
Dr. Earl: We were bifemoral this time. I put in a 7 French guide. I probably could have gotten away with a radial. But I figured 7 French guide, support catheter would give me the best platform to work.
Dr. Bilazarian: So tell us a little bit about left main interventional strategy, and what did you observe during the procedure with the Impella support?
Dr. Earl: Sure. So as I mentioned before, this was severe calcium. The lesion extended primarily into the LAD. The circumflex ostium was involved, but it wasn't critical. So my initial strategy was to wire the LAD, which we did with a Workhorse wire and exchanged out for a Rota-Floppy, and did serial Rota Burr runs with a 1.25 followed by a 1.5 burr. She did have significant hypotension with each burr run. I think that was one of the areas where the Impella really helped us out and allowed us to do really good aggressive lesion prep.
After atherectomy into the LAD, we did redirect our wire into the circumflex and also did single 1.5 burr passage into the ostial circumflex. After that we wired both limbs, the LAD and the circumflex, and did multiple thorough balloon inflations with non-compliant balloons into both limbs. Again, a situation where I think without adequate mechanical support, it can quickly become a situation where you're doing very quick and maybe inadequate lesion prep.
Dr. Bilazarian: How long would you approximate left the balloons up, the kissing balloons? Was it in the order of 15 seconds, or...?
Dr. Earl: We finished with kissing balloons. It was probably 20 seconds, 15 to 20 seconds, I would say.
Dr. Bilazarian: Okay, great. So at the conclusion of the procedure you have, obviously, this beautiful angiographic result, and your Impella is still on. Give some advice on what your strategy is at the conclusion when you think things have gone well, and you've gotten the support. Take us to the end of the gate.
Dr. Earl: Sure. So we did have hypotension with primarily Rota Burr runs and with balloon inflations, but once we had our stent results, her hemodynamics were great. Her native pulse pressure increased markedly. As is our routine, with high-risk PCI, we'll pre-close. We'll deploy two Perclose sutures around the arteriotomy site. As we do this more and more, even the reps in the room will kind of say, "We're getting close. Do you want us to start to wean?" So we'll start to wean the Impella device back as we're kind of taking final angiograms. Her hemodynamics remained rock stable. Like I said, our routine is to get these out at the conclusion of the case, which we did.
Dr. Bilazarian: Any tips or tricks? We have many physicians who are very capable interventionalists, but have hesitancy about 14 French intervention, access and closure particularly. Is it one of those things that is, I think you implied, largely of familiarity, but anything to encourage those who may be hesitant?
Dr. Earl: Being meticulous with IV access is critical here. I'll typically access the groin with as small as a 4 French sheath to start. Make sure we have a good arteriotomy position. Having contralateral access, I think, is helpful especially if you're just starting out here to where if you do have a problem with the large bore access site, you can certainly come up and over and deal with that from the contralateral groin.
We have a pretty active peripheral interventional lab here too. So there's always somebody around who could help if there's an issue. But I think these sheaths are getting smaller and smaller, and easier and easier to deal with. I do a lot of almost strictly coronary work, some structural work, do the majority of my work from the radial. So I'm used to doing 5 and 6 French interventions. But I think, with just a little bit of practice, most interventionalists are going to be pretty comfortable with a 14 French sheath.
Dr. Bilazarian: Fantastic. So tell us how the patient did subsequently after leaving the lab, and what was the course in the hospital?
Dr. Earl: She did great. Her hemodynamics were rock stable after intervention. Her blood pressure came up quite a bit actually. We'll typically keep these patients bed-bound for a good four to six hours. She was discharged home within 48 hours.
Dr. Bilazarian: Okay. Does the Impella change your disposition towards discharge? Say, the next day, 24 hours later? Obviously many of your patients need the additional time.
Dr. Earl: Sure. I've done 24 hours post discharge in some of these patients. A lot of comorbidities, of course, come into play: age, frailty, renal insufficiency, anemia, all those factors. But 24 to 48 hour disposition is not uncommon.
Dr. Bilazarian: Awesome. That was really, obviously, a great case, a left main intervention. Many times physicians may say that they can get away with this kind of intervention without support, but I think that your experience is what more and more physicians are finding. The added comfort of having the support to be able to do meticulous, excellent intervention with really great outcomes not only gets the patient out of the lab safely but really allows a sort of durable result because of presumably better debulking, better stent opposition, and better long term outcome. So thanks very much for sharing that great case.
Dr. Earl: You're welcome. I completely agree. I think the concept of being able to get away with an intervention like this is historical almost now with these devices.
Dr. Bilazarian: That's great. Well, I thank you for joining us.
Dr. Earl: You're welcome. Thank you.
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The Impella 2.5 system is a temporary (<6 hours) ventricular support device indicated for use during high risk percutaneous coronary interventions (PCI) performed in elective or urgent, hemodynamically stable patients with severe coronary artery disease and depressed left ventricular ejection fraction, when a heart team, including a cardiac surgeon, has determined high risk PCI is the appropriate therapeutic option. Use of the Impella 2.5 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.
Protected PCI and use of the Impella 2.5 is not right for every patient. Patients may not be able to be treated with Impella if they have certain pre-existing conditions, which a cardiologist can determine, such as: severe narrowing of the heart valve, severe peripheral artery disease, clots in blood vessels, or a replacement heart valve or certain heart valve deficiencies. Additionally, use of Impella has been associated with risks, including, but not limited to valvular and vascular injury, bleeding, and limb ischemia in certain patients. Learn more about the Impella devices’ approved indications for use, as well as important safety and risk information at www.protectedpci.com/hcp/information/isi.