Is the Bar Too Low for Transcatheter Mitral Repair in Real-World Practice?

NEW YORK CITY — Real-world operators have been leaving patients with acceptable but still less-than-optimal results after transcatheter mitral edge-to-edge repair (M-TEER), with some suggesting moving the goalposts for success.

The national Society of Thoracic Surgeons/American College of Cardiology (STS/ACC) TVT Registry showed that the Pascal Precision M-TEER system in commercial experience was associated with 86.6% freedom from all-cause mortality or heart failure hospitalization (HFH) at 1 year in over 4,600 people with degenerative mitral regurgitation (MR).

While clinical event rates were low, and there were significant improvements in quality of life, at 1 year there were nevertheless just 68.4% of patients left with the ideal result of mild or less MR (≤1+) and 92.9% of the total group with moderate or less MR (≤2+), per site-reported data.

It turns out that 62.4% of Pascal M-TEER patients had achieved optimal hemodynamics — MR ≤1+ and mitral valve gradients 5 mmHg or below — by discharge in the first place, according to Azeem Latib, MD, of Montefiore Medical Center in New York City, presenting at the New York Valves annual meeting hosted by the Cardiovascular Research Foundation.

The extent of Pascal’s real-world MR reductions is thus at least on par with what was achieved in its CLASP IID pivotal trial. Yet there is growing recognition that residual MR is a major contributor to poor clinical outcomes after M-TEER.

“We need to be getting to optimal MR reduction and not acceptable,” said session panelist Anita Asgar, MD, of Northwestern Medicine in Chicago. “How can we move the needle to get more optimal MR reduction with this device, as opposed to acceptable in common practice?”

“I would agree, I don’t think these are surgical repair-like results,” Latib responded.

Hemodynamic results were not better with the other M-TEER system on the market.

During the same session at New York Valves, there was an observational analysis of Pascal and the MitraClip, showing comparable procedural safety and efficacy between the two among all-comers with significant MR (degenerative or functional) undergoing M-TEER in 19 centers in North America, Europe, and Asia.

Notably, reduction to MR≤1+ at 30 days was similar with Pascal and MitraClip: 72.9% with Pascal and 68.8% with MitraClip. Before discharge, 76.1% of patients had MR down to mild or better with the Pascal versus 73% with MitraClip, reported Pier Pasquale Leone, MD, MSc, also of Montefiore Medical Center.

“The field’s rapidly moving forward and the expectations have to be redefined,” said session co-moderator David Adams, MD, of Icahn School of Medicine at Mount Sinai in New York City.

“I think we’ve got to be very careful, we can’t call moderate MR successful anymore,” he stressed. “We in surgery, we would never say that 68% good and 32% bad is a great outcome. We would all be horrified and having meetings all the time, talking about which patients should be trying something else or not intervening.”

Latib stressed the importance of matching patients to the right device.

“There are certain cases where I will not accept a result … I can’t get a good MR reduction, I take the device off because now I have other alternatives. I can potentially do valve replacement in that patient, and so I think as we have more devices in our toolbox, I think that’s what’s going to result in better outcomes,” he said.

Co-moderator Juan Granada, MD, of Cardiovascular Research Foundation, also in New York, cautioned that these MR patients are still high-risk given that they didn’t go to surgery. “I know we have to push the envelope and get zero MR. But you know, there’s a wide spectrum of patients — who knows who was elderly? Who was frail? — so I think as long as it’s a safe technology that reduces the MR, I wouldn’t criticize much this thing.”

Indeed, the STS/ACC TVT registry showed that Pascal M-TEER was associated with low 1-year event rates since the start of the U.S. commercial experience: 8.3% all-cause mortality, 3.3% cardiovascular mortality, 7.1% HFH, and 1.5% mitral valve reintervention.

“We have to get a better device, maybe in the future, I’m not sure how, but I don’t see this [residual MR] as a bad thing,” Granada stated.