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Mitral repair device safe, feasible
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Off-pump transapical implantation of artificial chordate to correct mitral regurgitation was found safe and feasible in a new study.
In light of increasing interest in transcatheter mitral valve treatment, researchers evaluated the NeoChord DS1000 system (NeoChord) for safety and performance in the Transapical Artificial Chordae Tendinae (TACT) trial.
Thirty eligible participants at seven centers had severe mitral regurgitation (MR) that resulted from isolated posterior prolapse. They were scheduled for off-pump transapical implantation of neo-chordae.
Death from postcardiotomy syndrome and concomitant sepsis were the major adverse events reported, along with one minor stroke that resulted in a full recovery at 30 days follow-up. The rate of any major adverse event during the first 30 days was 26.7%.
The researchers defined acute procedural success as placement of at least one neochord and a reduction in MR from 3+ or 4+ to ≤2+. An 87% procedural success rate was reported.
Early dehiscence occurred in two patients who were converted to standard of care. Another two patients failed to achieve acute procedural success and were also converted to standard treatment.
Technical and/or patient-specific reasons prevented placement of the neo-chordae in four patients. Standard mitral valve repair was performed in these patients, three of whom underwent intraoperative procedures and one underwent a postoperative procedure.
Seventeen patients maintained grade ≤2+ MR at 30 days follow-up. Clinicians successfully treated four patients with recurrent MR by performing open mitral valve repair during the 30-day follow-up period.
Experience contributed to more positive results, according to the researchers. Five of the first 15 patients experienced durable reductions in MR to ≤2+ at 30 days. Of the last 14 patients, 12 achieved this reduction.
“Off-pump transapical implantation of artificial chordae to correct [MR] is technically safe and feasible; however, it yields further potential for improvement of efficacy,” the researchers concluded.
Disclosure: The researchers report no relevant financial disclosures disclosures.
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