An error has occurred in the mitral repair of the transcatheter that will require valve replacement


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

“Patients need to understand that a failed TEER basically removes a surgical repair of the mitral valve and will need a mitral valve. valve replacement, ”said lead author Joanna Chikwe, MD, Cedars-Sinai, Los Angeles.

“This understanding needs to be integrated into this discussion and consent process as we extend the indication for TEER to younger, lower-risk patients, both in the context of clinical trials and in clinical practice,” he added.

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

It is a common misconception that mitral valve replacement is more durable than repair, said Chikwe, who is the chair of cardiac surgery at the Smidt Heart Institute in Cedars-Sinai. Compared to surgical repair, surgical valve replacement is associated with worse survival, a greater 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 truly maximizes long-term survival is competent and safe surgical repair of the mitral valve,” Chikwe noted. .

TEER is not currently recommended for younger patients who benefit from more than one long-term surgical repair. This recommendation is supported in 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 doable product, but it really depends on the patient and the team,” said Vincent Chan, a cardiac surgeon at the Ottawa Heart Institute, Ontario, Canada, who did not participate in the study. . Chan performs TEER and surgical mitral valve procedures.

“There are patients who are out of the attack zone for, say, a surgical repair of the mitral valve, and you really don’t want to open them up and do surgery, so you swing on the playing field and do TEER, but you may see a failure in this patient, Chan said.

By contrast, there are also good and bad TEER patients, he suggested, although he believes the current enthusiasm for the procedure is probably a bit exaggerated.

“If you have a very experienced surgeon available to do a surgical repair, this is probably your best option. Conversely, if the surgeons don’t have a lot of experience, this could drive the choice towards TEER, depending, of course. , also about patient characteristics, “he said in an interview.

Volume is important

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.

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

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

The observed mortality at 30 days or hospital was 10.2% in patients undergoing isolated mitral surgery, higher than 6.5% of the mortality predicted by mean STS, obtaining a proportion of observed and expected mortality of 1, 2.

In four hospitals that performed more than 10 cases, operative mortality was 2.6%, compared with 12.4% in centers that performed less than 10 cases (Pg = .01).

These data surprised Chikwe, who does surgical procedures but not TEER. “I know they are valves that are very difficult to repair surgically and, at our institution, we have been able to repair most of them, but while I suspected that our experience did not reflect national practice, I did not expect more than 95% of ‘these valves would be replaced instead of repaired’.

MitraClip is currently the only TEER device approved by the U.S. Food and Drug Administration. Edwards Lifesciences ’PASCAL transcapital mitral valve repair system is currently approved in the European Union for TEER. First discoveries of the company in progress CLASS IID The trial, a direct comparison of Pascal and MitraClip, is expected in December 2023.

As for the TEER failure rate with MitraClip, he said the information is not clearly known, but after a year it appears that around 20% of MitraClip recipients have died or have moderate mitral regurgitation and they need repeated intervention.

“Again, there are substantial variations between institutions and the results have improved as we have gained more experience. We also know that procedural and long-term success depends a lot on the selection of cases. If you select the right patients, your failure rate should be lower, ”Chikwe added.

Chikwe did not report any relevant conflicts of interest. Several other authors of the paper reported relationships with transcaterial valve manufacturers, including Abbott, Edwards Lifesciences, and Medtronic. Chan did not report any conflicts of interest.

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

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