麻豆传媒

WASHINGTON -- A roundup of new devices designed to treat tricuspid regurgitation revived a long-standing kerfuffle between surgeons and interventionists on what roles they have when encountering a condition that is, more often than not, secondary to others such as left-side valvular disease.

"Tricuspid regurgitation is bad, and tricuspid regurgitation surgery is good, but tricuspid regurgitation is ignored by interventionists," contended , a cardiac surgeon at Michigan Medicine in Ann Arbor, as he described the emerging percutaneous devices at the annual Cardiovascular Research Technologies meeting here.

Several panelists took turns at the podium describing the latest technologies:

• (Edwards Lifesciences): a repair system consisting of a spacer and a rail; it has been used so far in 18 patients as compassionate use. Operators observed functional improvement in 30 days, though lapses occurred within the year.

• (4Tech): a repair system still in the early phases of development with a new anchoring mechanism to be implemented. Enrollment for the device's PREVENT feasibility trial is now complete.
• MitraClip (Abbott Vascular): the most used device for tricuspid valve repair with 250 cases worldwide, the Mitraclip's early results seem promising. The MitraClip XT is being designed with longer arms for improved grasping.
• (Mitralign): still in early-stage development, but a feasibility study showed high procedural success and clinical improvement after implantation.
• (Valtech): six successful compassionate cases resulted in annular diameter reduction and substantial hemodynamic improvement. Investigators are currently recruiting for a European registration study.
• (Edwards Lifesciences): heterotopic implantation of the valve will be under investigation in the 30-patient HOVER registry.

"We like the concept of a percutaneous approach to these patients because of less biological impact," Bolling emphasized. "Don't forget it! Don't neglect it! Just do it!"

"I have the highest respect for the devices out there," commented , an interventionist at Siegburg Heart Centre in Germany. "But the bottom line is what are we trying to achieve? We know when we go to 2+ the patient comes back."

"We know some devices just reduce [tricuspid regurgitation] to 2+ or 1+. If there was a device that followed surgical best practice, which is zero, should we aim for that? Or aim to let the patient go with improved symptoms?"

"It depends on the patient," responded , an interventionist at Seattle's University of Washington Medical Center, arguing that the lofty goal of eliminating tricuspid regurgitation requires a longer procedure that wouldn't make sense for every patient.

"From the cases we do at the beginning we see ugly lesions. That jet is not good. Afterwards the jet is better, the patient is doing better, the liver function is better. At first I said we need to eliminate regurgitation. Now I think in some -- no, many -- patients, relieving a bit of the regurgitation can be a lot," Dvir said.

Bolling fired back dramatically: "I agree with you (pause) not in the slightest."

"As we've learned in the mitral space, we used to think it was okay for 2+ but that predicts recurrence. My goal is to have zero mitral regurgitation -- that's the best. We have to learn from our experiences surgically again that having no tricuspid regurgitation is the best. Our goal should be very high."

Bolling maintained: "If i could give you a choice of zero or 2+ tricuspid regurgitation you would want the zero."

"You just made the day of all the device makers that are sponsoring these programs," commented , an interventionist at Columbia University Medical Center/New York-Presbyterian Hospital. "It would be lovely if surgeons took care of the tricuspid regurgitation but you haven't so we're left with patients who have had surgery who have mortality for re-do surgery at 35% and torrential tricuspid regurgitation. So we're getting referrals from surgeons, they don't want them."

"We have devices that could treat 2+ and take it to zero -- but we don't see 2+," she emphasized.

, a cardiac surgeon at University Hospital Zurich, said that he, too, disagreed with Bolling. "These patients leaving the hospital with 3+ tricuspid regurgitation, they do much better," he continued, arguing that tricuspid regurgitation classification itself is wrong.

Another major problem: the lack of standardized reporting of tricuspid regurgitation, according to , an interventionist at Cleveland Clinic.

He expressed agreement with the view that completely eliminating tricuspid regurgitation "is unachievable right now when we have torrential tricuspid regurgitation in the patient."

So what now?

Maisano said it was important not to compare the early-stage devices presented since their entry points are "completely different." Moreover, he predicted that the biggest challenge would be analyzing upcoming data in a population that is very high-risk -- which will not be the ideal population years from now.

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