Failed transcatheter edge-to-edge repair of functional and degenerative mitral regurgitation (MR) with the MitraClip (Abbott) is relatively uncommon at high-volume centers but associated with a high rate of poor outcomes on follow-up, researchers say.
MitraClip failure, which included loss of leaflet insertion, single leaflet detachment, or clip embolization, occurred in 3.5% of 4294 procedures performed at 19 centers in Europe and Israel.
After an average follow-up of 142 days, 43% of patients with a failed MitraClip still had moderate-to-severe MR and nearly a third (29.3%) had died.
"We found no correlation between the volume [of the] center or the rate of detachment or of failure. So it means that even in very experienced centers, we have not reduced the rate of MitraClip failures secondary to loss of leaflet insertion or single leaflet detachment," said lead investigator Antonio Mangieri, MD, IRCCS Humanitas Scientific Institute, Milan, Italy.
"And, we also found through the years, a significant increase in the number of MitraClip failures, maybe related to the treatment of more complex anatomical scenarios," he said.
The results were presented during a recent online session of "key abstracts" released as part of Transcatheter Cardiovascular Therapeutics (TCT) 2021, to be held November 4 to 6 online and in Orlando, Florida.
To investigate the prevalence, management, and outcomes of patients with functional and degenerative MR who experience MitraClip failure, Mangieri and colleagues used data collected retrospectively in the Failed mItraclip Long-term follow-up and Management (FILM) database.
They defined single leaflet detachment as the complete loss of connection between the MitraClip and one leaflet. For loss of leaflet insertion, the device is still attached to both leaflets but damaged with a tear, perforation, or distortion in shape. Clip embolization is the complete loss of contact between the clip and both leaflets.
Of the 147 MitraClip failures, 67.3% were single leaflet detachments, 31.9% were loss of leaflet insertion, and one involved clip embolization.
Failures were reported in 67 patients with functional MR, 64 with degenerative MR, and 16 with mixed etiology. Overall, the baseline characteristics of the three subgroups were similar, although patients with degenerative MR were, as expected, slightly older and had a lower left ventricular ejection fraction, Mangieri noted. Fibroelastic deficiency was also significantly more common in patients with degenerative MR, at 27.6%. "So it seems to be a very important marker of failure," he said.
In all, 71 patients were managed medically and 51 underwent redo MitraClip procedures, of which 38 cases were successful. Six of the 13 unsuccessful cases were shifted to medical therapy and seven to surgery, he said.
Of the 32 patients who ultimately had surgery, mitral valve replacement was performed in 23, mitral valve repair in seven, and left ventricular assist device placement in six.
Mangieri noted that because of the study enrollment period, most procedures were performed with the MitraClip NTR rather than the MitraClip XTR or fourth-generation (G4 NTW/G4 XTW) devices.
The study also lacked a control group, the prevalence of leaflet insertion and single leaflet detachment was not systematically searched at follow-up and may have been influenced by imaging techniques, and echocardiography data were site reported.
"In high-volume centers, the MitraClip failure is typically uncommon with an incidence of 3.5% and is associated with a high rate of moderate-to-severe MR and death at follow-up," Mangieri concluded.
Session co-moderator Alexandre Abizaid, MD, PhD, Heart Institute, InCor, University of Sao Paulo Medical School, Brazil, said "due to the number of patients, this is very informative and will bring some light to what to do with these patients."
He questioned whether the G4 MitraClip, with its larger arms and ability to separately clip the leaflets, or the PASCAL (Edwards Lifesciences) device would improve management of these patients, mainly the redo cases, and added, "I think that this is a good case for a percutaneous annuloplasty when you fail to do the edge-to-edge, perhaps with the Cardioband."
Mangieri replied that the G4 "lets us treat more complex anatomy and in these cases we can obtain very good results, but at the same time my perception is we can have a distortion of the mitral valve structure and sometimes we can also have some residual regurg, which originates very close to the clip or from the opening of some clefts."
He cautioned that operators need to be meticulous in placing the devices, observing that operators tend to be very aggressive with the first MitraClip procedure. "We have to find a very important balance."
Mangieri highlighted a 2016 case report by the team demonstrating the feasibility of percutaneous annuloplasty with Cardioband (Edwards Lifesciences) in a patient with heart failure and residual MR after a failed edge-to-edge repair with two MitraClips.
"I think this is an important key tool that we have to keep in mind when we have some patients with residual regurgitation," he agreed.
Mangieri and Abizaid have disclosed no relevant financial relationships.
Transcatheter Cardiovascular Therapeutics (TCT) 2012. Presented October 7, 2021.
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Medscape Medical News © 2021
Cite this: Patrice Wendling. MitraClip Failure: An Uncommon but Dire Occurrence - Medscape - Oct 15, 2021.