A First In Humans
Transcatheter Repair of a Patient’s Severely Regurgitant Tricuspid Valve

Interview | Severe tricuspid regurgitation is associated with severe consequences. Unfortunately, there are not many Class 1 indications to help manage the interventional care of these patients. Consequently, very high-risk surgical patients may go untreated. CardioSource WorldNews: Interventions had the opportunity to speak with Rebecca Hahn, MD, Director of Interventional Cardiography at the Columbia University Medical Center New York Presbyterian Hospital, about her recent paper in JACC, which reported on the first in-human successful transcatheter tricuspid valve repair.

CSWN Interventions: Let’s start with a little history about this approach. How did it come about?
Rebecca Hahn, MD, FACC: Well, this is an approach that was designed for the mitral valve and the mitral sphere for mitral repair. Transcatheter mitral repair has just a number of different devices out there. And this is a device that was designed as a direct annuloplasty device. It’s a suture device that you can put in pairs of pledgeted sutures and then draw those sutures together in order to reduce the annular dimensions. So it has been successfully used on the mitral side. [Researchers are] analyzing their data now, but then the thought came to them that they could actually easily transfer that over to the tricuspid side, which is a purely venous intervention and would therefore be relatively safe. They’ve successfully migrated their mitral device over to the tricuspid side with very little changes.

Now this whole thing was designed with the idea in mind that interventional echocardiography would be a key element of this, correct?
Yes. The beauty of these—the first-in-man, the first-in-human—was that the [cardiologists] actually asked me to come over to implant this with Joachim Schofer, MD, in Hamburg, Germany, and I think it’s really the first that I’ve ever heard that an echocardiographer has now become one of the essential players to the heart team in these new devices in trying to ensure the success of these new devices. So it was a lot of fun for me to go over and work with this wonderful team of people.

Talk about the JACC paper—tell us about the patient, who it was and what you did.
This was an elderly patient who had isolated tricuspid regurgitation, and that’s a population of patients that doesn’t have left-side valvular or heart disease, and it’s a patient population that has recently been described. The outcome natural history of that disease is abysmal. And so the outcomes are poor. It’s a patient population that we have no Class 1 indications for intervention. The current Class 1 indications in our guidelines is for intervention on the tricuspid side if you are going in already for the mitral. And so it’s a patient who was a high-risk surgical candidate for an isolated tricuspid procedure. And so we went ahead and she consented to the procedure—and it just, it went very, very smoothly. We saw an immediate effect. The patient was able to diurese very effectively in hospital, went home in just 5 days, and it was a great result for the first in-human [procedure].

So now that you’ve had a glass of champagne, what’s next?
Well they’re going ahead and implanting in more patients. There are now a total of five. All five of these—the first five—have all successfully had devices implanted. Either two or three pledgeted devices all have had a greater than 50% reduction in the annular area, which is phenomenal. All have had somewhere between a 30% to 50% reduction in the quantification of tricuspid regurgitation, and I think, procedurally, the success rate is phenomenal. Now the next steps are to try and really fine-tune the procedure to optimize the amount of regurgitant reduction and to really fine-tune how many pledgets, where to position them, etc. But I think with the first five procedural successes is really something for a new device.

Well, we’ve had a lot of success with TAVR, and so I think that is encouraging and inspiring researchers to move ahead and try something different in these patients.
Yes, it’s definitely true. I think as we go more to transcatheter devices, less invasive, we’re really encouraged though by the initial results.

Schofer J, Bijuklic K, Tiburtius C, et al. J Am Coll Cardiol. 2015;65(12):1190-95.

Clinical Topics: Cardiac Surgery, Invasive Cardiovascular Angiography and Intervention, Interventions and Structural Heart Disease

Keywords: CardioSource WorldNews Interventions, Cardiac Surgical Procedures, Tricuspid Valve Insufficiency

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