MitraClip Post-Approval Study 1 (PAS-1) – Presented at the SCAI 2018 Scientific Sessions

Dr. James Hermiller, from The St. Vincent Medical Group at The Heart Center, discusses results from the study titled “The Abbott Post-Approval Study 1 MitraClip Registry: 1-year Results of the First 2,000 Patients in the Transcatheter Valve Therapy Registry” that was presented at the Society for Cardiovascular Angiography and Interventions (SCAI) 2018 Scientific Sessions. To learn more about this research, you may view a slideshow presentation here.

Guest Bio: Dr. Hermiller graduated summa cum laude from Miami University, Oxford OH and The Ohio State School of Medicine, Columbus Ohio. He completed an Internal Medicine Internship and Residency at the National Naval Medical Center in Bethesda, Maryland, where he was also chief resident. He completed his Cardiology Fellowship at Duke University Medical Center, Durham, NC. Dr. Hermiller joined St. Vincent Medical Group in 1992. He serves as Director of the Interventional Cardiology Fellowship and Structural Heart Programs at St Vincent Heart Center, Indianapolis, IN.

Transcript

Neal Howard: Hello and welcome to the program. I’m your host, Neal Howard here on Health Professional Radio. Glad that you could join us. In our series on the 2018 Scientific Sessions of the Society for Cardiovascular and Angiography and Interventions, Dr. James Hermiller is joining us today from the St. Vincent Medical Group at the Heart Center to discuss the results of one of the studies that was presented there. Welcome to the program Dr. Hermiller.

James Hermiller: Neal, thanks so much. It’s a pleasure to be here.

N: Great. Give us a bit of background about yourself and let’s jump right into this Abbott post-approval study.

J: I’m in Indianapolis at St. Vincent Heart Center, an interventional cardiologist here and we’re going to talk about the Mitraclip today. It’s actually something I’ve been involved in for the last decade plus. It turns out that the Mitraclip is approved for patients who are at high risk for standard open-heart surgery for their mitral valve surgery and probably half of all patients who are symptomatic from severe mitral regurgitation really don’t get an option to have surgery – they’re too old or too sick. So that’s what the Mitraclip is for and about 60,000 patients worldwide have been treated. It was approved in the US back in 2013 and this represents a post-approval study sort of the FDA required Abbott when they approved it to look at these patients and that’s what we’re going to talk about.

N: So what were some of the results?

J: It was the first 2,000 patients treated in the US. First of all, the procedure itself was very successful. The number of patients who had clips implanted was 97% plus. If we look at some of the earlier results it was much less than this. Actually, the procedure times and device times were quite reasonable, a device time about an hour and a half. So it really got much better over the years, technically pulling us in.

N: You say that you’ve been involved with this particular Mitraclip for the last decade or so. Does these last couple of years represent a huge jump as far as improvements?

J: Yes. What I would say is really, probably at about the time this was approved, the energy that really drives us – its cardiac ultrasound, its transesophageal echocardiography has gotten so good that we’re able to see what we’re doing much better and so the procedure’s much more effective and I think efficient. So I think that’s what’s really driving that success.

N: You mentioned patients that were either too old or too sick to have the surgery. Are we talking significant longevity in these first 2,000 patients?

J: Yes. If you kind of look at the average age of those patients 79 1/2 years old. They were elderly. Their risk as far as open heart surgery estimated from the regular risk score was about 11% which is very high for open-heart surgery these days. So another high-risk patients, they’ve had open-heart surgery many of them before there’s renal dysfunction somewhere on dialysis but their life expectancy is still pretty darn good. If you look at the mortality over that first … group of patients, it was about 20% which for this elderly sick group is actually better than one would estimate if you didn’t treat them with severe mitral regurgitation. The other thing was that the incidence of complications related to that procedure were quite low – stroke was very low, bleeding was low, the need for a repeat intervention to the mitral valve was quite low.

N: Were these results, things that were expected based on the research and development over the last you say the last decade or so? Or were there any surprises that maybe will catapult this research even further?

J: Yes. Great question. I think what was surprising is that when you sort of started to use this in the real world with operators who weren’t experienced, actually the data reflect very well what was seen in all the randomized and the control trials in expert centers. So the way that this was transmitted out in the community really reflected what we’ve seen in the research studies and that’s really what we like to see. I hate to release a new technology that’s so complex that when it’s actually used out, you don’t get the results that you do during that studies in the big center. So I think that was very reassuring.

N: What about patient understanding of the procedures and how it’s going to benefit them?

J: Yes. First of all, if you look at the ability to reduce that leakage of the mitral valve regurgitation by a year follow-up 85% still had mild to modest mitral regurgitation and 95% plus started with severe mitral regurgitation. So you were able to really reduce the amount of leak. We also saw that the heart remodel, the chamber sizes were reduced which is a favorable finding and if you look at how the patients felt. So 80, 90% of them had advanced symptoms when they came in, advanced heart failure symptoms and at a year it flipped 85% of them really were feeling well. They were function class one or two. It was sort of dramatic improvement on how they felt.

N: Well, based on these positive results, what do you think is next for the study?

J: Yes. If you look at what the approval is right now for the Mitraclip in the US, it is for patients with primary valvular mitral regurgitation. Generally, they have mitral valve prolapse but they’re too old to have open-heart surgery. The next big thing is to get this approved for patients who have secondary mitral regurgitation – they have heart failure, they have ventricular dilation. Their valve actually is okay, the leaflets are okay but they’ve been pulled apart because the ventricle is sick. And this is approved over in Europe and many of the other places in the world but we don’t have that approval yet in the US and there’s going to be a large randomized trial comparing the Mitraclip and medical therapy in that group of patients which we expect to come out in the fall and that’ll be a very important study. It’s called COAPT.

N: Well, where can go online and learn more about the St. Vincent Medical Group and about the 2018 scientific sessions as well?

J: Yes. It was really exciting – San Diego this year for SCAI. I would say one other thing that I didn’t mention is the quality of life. We did a quality of life questionnaire and the metrics for quality of life almost doubled which is sort of unheard of. So these patients, they felt better as far as their
functional standards but their quality of life substantially improved and then these elderly sick patients and that’s what they really want.

N: Well, it’s been a pleasure talking with you today, James and I’m hoping you’ll give us some updates as things progress as this approval moves forward and research progresses as well. Thank you so much for coming in today.

J: Thank you so much for having me.

N: You’ve been listening to Health Professional Radio in studio with Dr. James Hermiller. Transcripts and audio of this program are available at healthprofessionalradio.com.au and also at hpr.fm. You can subscribe to this podcast on iTunes, listen in and download a SoundCloud and be sure to visit our affiliates page at hpr.fm.

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