Transcatheter Valve-in-Ring for Failed Tricuspid Repair: New Hope for Patients With Few Options

Off-label use of transcatheter valves can benefit patients who experience tricuspid valve dysfunction after previously undergoing surgical repair, according to new results from an international multicenter registry.

This is good news for the 25% of patients who start to develop progressive moderate or severe tricuspid regurgitation within 5 years of their initial surgical annuloplasty procedures, lead author Jamil Aboulhosn, MD (University of California, Los Angeles), and colleagues say.

Speaking to the rarity of this procedure—known as transcatheter valve-in-ring implantation—is the fact that the study, published online earlier this week in JACC: Cardiovascular Interventions, included only 22 patients treated at 13 sites. “Frankly, it’s very challenging,” Aboulhosn told TCTMD, describing myriad anatomic and procedural hurdles.

Moreover, “these patients often have a number of other comorbidities,” he added. “They are typically high risk for repeat surgery. Some of them have evidence of end-organ damage from the chronic right heart failure, so they may have liver cirrhosis or kidney problems. It makes them less than ideal surgical candidates.

“That’s how I got into it,” Aboulhosn continued. “I had patients who just were not going to make it through another operation.”

Indeed, as Patrick M. McCarthy, MD (Northwestern University, Chicago, IL), notes in an accompanying editorial, off-label valve-in-ring “is potentially the only option” for this patient population. “Overall, these early results are encouraging and based on clinical reports and experience likely pose less risk than a complex reoperation for these very sick patients,” he writes. “Now that there is growing recognition that there are nonsurgical interventions for patients with recurrent tricuspid regurgitation following annulopasty, hopefully the referral patterns will change and we will see these patients sent early.”

PVL Common but Can Be Fixed

For their report, Aboulhosn and colleagues looked at 22 patients with prior tricuspid valve repair procedures involving annuloplasty rings or bands in whom transcatheter valve-in-ring implantation was attempted. Procedures were successful for 20 patients (91%) within that group. At baseline, most were NYHA functional class III or IV and 86% had severe tricuspid regurgitation. Three received a Melody valve (Medtronic) and 17 a Sapien valve (Edwards Lifesciences).

No procedural deaths occurred, though there was one valve embolization requiring retrieval and one case of valve malposition with severe paravalvular regurgitation; both required a second transcatheter valve-in-ring implantation. In all, four patients were treated for significant PVL at the time of the initial implantation.

Over a median follow-up of 12 months, one patient died and two had repeat valve-in-ring procedures (with one eventually needing surgical replacement). Follow-up echocardiography showed that 15 of the 20 patients had paravalvular leak (PVL), though 75% of those cases were trivial or mild. Three patients eventually needed additional interventions to address their PVL.

That said, 70% of patients gained better functional capacity after their valve-in-ring procedures.

‘Stick the Landing’

To TCTMD, Aboulhosn outlined what makes these cases so difficult.

Annuloplasty rings or bands implanted surgically in the tricuspid valve do not offer uniform or circumferential landing zones to operators, he said. And unlike the aortic and mitral valves, which are relatively immobile, the tricuspid valve moves with every beat; it also comes with difficult-to-navigate chordae. “You’re landing the valve on this little, skinny ring, so you have to stick the landing perfectly,” Aboulhosn commented.

Balloon sizing, the paper notes, is key and can be “used to assess the true dimensions of the ring, potential changes in geometry with expansion, and any residual TR prior to proceeding with [transcatheter valve-in-ring] implantation.”

Another challenge is that devices being used, Melody and Sapien, were designed for the pulmonary and aortic valve, respectively, and as such their ordinarily round diameters get pushed into an elliptical shape when inserted into annuloplasty rings. “So that was reassuring to see from this data that the tricuspid valve itself that was implanted works very nicely in this position,” he noted, adding that when PVL does occur, “it can be plugged up using devices we have.”

If this is the first time you approach the tricuspid valve and you’re trying to drive this 18-wheeler truck and land it on a line, . . . good luck. You might end up in trouble here. Jamil Aboulhosn

There had been worries that implanting a balloon-expanded, high-radial-force transcatheter valve in this way would damage the conduction system and cause heart block, or that attempts to prevent or treat PVL could cause similar problems. “However, we were very happy to find that that was not much of an issue at all,” Aboulhosn reported.

As to who should be performing valve-in-ring cases, Aboulhosn was circumspect: “This procedure is best done by highly experienced operators who’ve done a lot of transcatheter valve replacement work, and preferably those who have worked on the right side as well as the left side of the heart, not just those who have worked on the aortic position.”

Having the right skill set is important, he stressed, “because if this is the first time you approach the tricuspid valve and you’re trying to drive this 18-wheeler truck and land it on a line, . . . good luck. You might end up in trouble here.”