Failed Transcatheter Mitral Repair Will Require Valve Replacement

Debra L. Beck

May 07, 2021

In patients who had undergone transcatheter edge-to-edge (TEER) mitral valve repair and required reintervention, less than 5% underwent a surgical mitral valve repair rather than a replacement procedure, a new study shows.

"Patients need to understand that a failed TEER essentially takes a surgical mitral valve repair off the table, and they'll need a mitral valve replacement," said lead author Joanna Chikwe, MD, Cedars-Sinai, Los Angeles.

"This understanding needs to be embedded in this discussion and the consent process as we expand the indication for TEER to younger and lower-risk patients, both in the setting of clinical trials and in clinical practice," she added.

Chikwe and colleagues presented their findings on May 1 at the annual American Association for Thoracic Surgery meeting, held online this year, and simultaneously published in the Journal of the American College of Cardiology.

It's a common misunderstanding that mitral valve replacement is more durable than repair, noted Chikwe, who is the chair of cardiac surgery at the Smidt Heart Institute at Cedars-Sinai. Compared with surgical repair, surgical valve replacement is associated with worse survival, a higher need for reintervention, and higher rates of stroke.

"In patients with mitral valve prolapse, the most durable option, the safest option, and the option that really maximizes long-term survival is a competent, safe surgical mitral valve repair," noted Chikwe.

TEER is not currently recommended for younger patients who benefit more from a surgical repair in the long term. That recommendation is supported by this study of 463 patients who underwent a MitraClip procedure, providing the first national data on surgical outcomes when TEER fails.

"MitraClip is a very safe and very feasible, but it really depends on the patient and the team," said Vincent Chan, MD, a cardiac surgeon at the Ottawa Heart Institute, Ontario, Canada, who was not involved in the study. Chan does both TEER and surgical mitral valve procedures.

"There are patients who are outside the strike zone for, say, a surgical mitral valve repair, and you really don't want to cut them open and do surgery, so you swing at the pitch and do TEER, but then you might see a failure in that patient, said Chan.

Conversely, there are also good and bad TEER patients, he suggested, although he thinks the current enthusiasm for the procedure is likely a bit overblown.

"If you have a highly experienced surgeon available to do a surgical repair, well then that is very possibly your best option. Conversely, if the surgeons are not very experienced, then that might push the choice toward TEER, depending, of course, also on patient characteristics," he said in an interview.

Volume Matters

Study participants were identified from the Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database, had a mean age of 76 years, and underwent mitral surgery after TEER between July 2014 and June 2020.

Concomitant cardiac surgery in addition to mitral valve surgery was performed in 51.2% of patients; the rest underwent isolated valve procedures.

The surgical repair rate after failed TEER was only 4.8% overall, and 6.8% in patients with degenerative disease.

Observed 30-day or in-hospital mortality was 10.2% in patients undergoing isolated mitral surgery, higher than the 6.5% median STS predicted mortality, yielding a ratio of observed to expected mortality of 1.2.

In four hospital centers that performed more than 10 cases, operative mortality was 2.6%, compared with 12.4% in centers performing fewer than 10 cases (P = .01).

These data surprised Chikwe, who does surgical procedures but not TEER. "I know that these are very challenging valves to repair surgically, and at our institution, we've been able to repair most of them, but while I suspected our experience wasn't reflective of national practice, I didn't quite expect that more than 95% of these valves would be replaced rather than repaired."

MitraClip is currently the only TEER device approved by the US Food and Drug Administration. The PASCAL transcatheter mitral valve repair system from Edwards Lifesciences is currently approved in the European Union for TEER. Early findings from the company's ongoing CLASP IID trial, a head-to-head comparison of Pascal and MitraClip, are expected in December 2023.

As for the rate of TEER failure with MitraClip, she said that information isn't clearly known, but at 1 year, it appears that about 20% of MitraClip recipients have either died or have moderate mitral regurgitation and need a repeat intervention.

"Again, there is substantial variation among institutions, and outcomes have improved as we've gained more experience. We also know that procedural and longer-term success is very dependent on case selection. If you select the right patients, your failure rate should be lower," Chikwe added.

Chikwe reported no relevant conflict of interest. Several of the other authors on the paper reported relationships with transcatheter valve manufacturers, including Abbott, Edwards Lifesciences and Medtronic. Chan reported no conflict of interest.

J Am Coll Cardiol. Published online May 1, 2021. Abstract


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