Failed transcatheter edge-to-edge repair of realistic and degenerative mitral regurgitation (MR) with the MitraClip (Abbott) is comparatively unfamiliar at excessive-quantity centers but connected with a excessive rate of unhappy outcomes on practice-up, researchers dispute.
MitraClip failure, which incorporated lack 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 a median practice-up of 142 days, 43% of patients with a failed MitraClip quiet had reasonable-to-severe MR and nearly a third (29.3%) had died.
“We realized no correlation between the quantity [of the] center or the rate of detachment or of failure. So it manner that even in very experienced centers, we occupy now not diminished the rate of MitraClip disasters secondary to lack of leaflet insertion or single leaflet detachment,” stated lead investigator Antonio Mangieri, MD, IRCCS Humanitas Scientific Institute, Milan, Italy.
“And, we furthermore realized by the years, a fundamental receive bigger in the selection of MitraClip disasters, presumably connected to the treatment of extra complex anatomical eventualities,” he stated.
The outcomes occupy been introduced actual by a latest online session of “key abstracts” launched as fragment of Transcatheter Cardiovascular Therapeutics (TCT) 2021, to be held November 4 to 6 online and in Orlando, Florida.
To look at the prevalence, management, and outcomes of patients with realistic and degenerative MR who trip MitraClip failure, Mangieri and colleagues old data accumulated retrospectively in the Failed mItraclip Long-duration of time practice-up and Administration (FILM) database.
They defined single leaflet detachment as the total lack of connection between the MitraClip and one leaflet. For lack of leaflet insertion, the utility is quiet connected to both leaflets but damaged with a ride, perforation, or distortion in form. Clip embolization is the total lack of contact between the clip and both leaflets.
Of the 147 MitraClip disasters, 67.3% occupy been single leaflet detachments, 31.9% occupy been lack of leaflet insertion, and one eager clip embolization.
Disasters occupy been reported in 67 patients with realistic MR, 64 with degenerative MR, and 16 with mixed etiology. General, the baseline characteristics of the three subgroups occupy been same, even although patients with degenerative MR occupy been, as anticipated, a chunk of older and had a lower left ventricular ejection piece, Mangieri favorite. Fibroelastic deficiency used to be furthermore a good deal extra general in patients with degenerative MR, at 27.6%. “So it seems to be to be to be a crucial marker of failure,” he stated.
In all, 71 patients occupy been managed medically and 51 underwent redo MitraClip procedures, of which 38 conditions occupy been winning. Six of the 13 unsuccessful conditions occupy been shifted to scientific therapy and seven to surgical treatment, he stated.
Of the 32 patients who in the raze had surgical treatment, mitral valve replacement used to be performed in 23, mitral valve repair in seven, and left ventricular lend a hand utility placement in six.
Mangieri favorite that because of the witness enrollment duration, most procedures occupy been performed with the MitraClip NTR moderately than the MitraClip XTR or fourth-generation (G4 NTW/G4 XTW) devices.
The witness furthermore lacked a support an eye on community, the prevalence of leaflet insertion and single leaflet detachment used to be now not systematically searched at practice-up and can should always occupy been influenced by imaging tactics, and echocardiography data occupy been net site reported.
“In excessive-quantity centers, the MitraClip failure is in most cases unfamiliar with an incidence of 3.5% and is expounded with a excessive rate of reasonable-to-severe MR and death at practice-up,” Mangieri concluded.
Session co-moderator Alexandre Abizaid, MD, PhD, Coronary heart Institute, InCor, College of Sao Paulo Medical College, Brazil, stated “attributable to the selection of patients, that would possibly maybe be very informative and should always bring some light to what to attain with these patients.”
He questioned whether or now not the G4 MitraClip, with its better fingers and skill to separately clip the leaflets, or the PASCAL (Edwards Lifesciences) utility would toughen management of these patients, mainly the redo conditions, and added, “I judge that that is an exact case for a percutaneous annuloplasty do it is advisable to fail to attain the sting-to-edge, presumably with the Cardioband.”
Mangieri answered that the G4 “lets us kind out extra complex anatomy and in these conditions we can execute very trusty outcomes, but at the identical time my notion is we can occupy a distortion of the mitral valve structure and once in a while we can furthermore occupy some residual regurg, which originates very shut to the clip or from the gap of some clefts.”
He cautioned that operators settle on to be meticulous in placing the devices, watching that operators are usually very aggressive with the first MitraClip procedure. “Now we occupy to uncover a crucial balance.”
Mangieri highlighted a 2016 case file by the group demonstrating the feasibility of percutaneous annuloplasty with Cardioband (Edwards Lifesciences) in a affected person with coronary heart failure and residual MR after a failed edge-to-edge repair with two MitraClips.
“I judge that is an crucial key utility that we occupy to support in solutions when we occupy some patients with residual regurgitation,” he agreed.
Mangieri and Abizaid occupy disclosed no connected financial relationships.
Transcatheter Cardiovascular Therapeutics (TCT) 2012. Introduced October 7, 2021.