Format

Send to

Choose Destination

See 1 citation found by title matching your search:

J Am Coll Cardiol. 2014 Mar 11;63(9):914-9. doi: 10.1016/j.jacc.2013.07.090. Epub 2013 Sep 24.

Off-pump transapical implantation of artificial neo-chordae to correct mitral regurgitation: the TACT Trial (Transapical Artificial Chordae Tendinae) proof of concept.

Author information

1
Department of Cardiac Surgery, Heartcentre Leipzig, Leipzig, Germany. Electronic address: joerg.seeburger@medizin.uni-leipzig.de.
2
Clinic for Cardiac Surgery, University of Turin, Turin, Italy.
3
Department of Cardio-thoracic and Vascular Surgery, Aarhus University, Aarhus, Denmark.
4
Department of Cardiac Surgery, German Heart Centre, Munich, Germany.
5
Department of Cardiac Surgery, Kerckhoff Klinik, Bad Nauheim, Germany.
6
Department of Cardiac Surgery, St. Raffaelo Hospital, Milan, Italy.
7
Department of Cardiac Surgery, Heartcentre Leipzig, Leipzig, Germany.
8
Department of Cardiac Surgery, Vilnius University, Vilnius, Lithuania.

Abstract

OBJECTIVES:

The goal of this study was to evaluate the safety and performance of the NeoChord DS1000 system (NeoChord, Inc., Minneapolis, Minnesota).

BACKGROUND:

There is an increasing interest in transcatheter mitral valve (MV) treatment. The NeoChord DS 1000 system enables off-pump beating heart transapical MV repair with implantation of artificial neo-chordae.

METHODS:

Patients with severe mitral regurgitation (MR) due to isolated posterior prolapse were included in this TACT (Transapical Artificial Chordae Tendinae) trial. All patients were scheduled for off-pump transapical implantation of neo-chordae.

RESULTS:

Thirty patients at 7 centers were enrolled. Major adverse events included 1 death due to post-cardiotomy syndrome and concomitant sepsis and 1 minor stroke with the patient fully recovered at the 30-day follow-up visit. Additional patients experienced procedural major adverse events related to a reoperation or conversion to standard of care. Acute procedural success (placement of at least 1 neo-chord and reduction of MR from 3+ or 4+ to ≤2+) was achieved in 26 patients (86.7%). In 4 patients neo-chordae were not placed for technical and/or patient-specific reasons. These patients underwent intraoperative (3 patients) or post-operative (1 patient) standard MV repair. At 30 days, 17 patients maintained an MR grade ≤2+. Four patients who developed recurrent MR were successfully treated with open MV repair during 30-day follow-up. Results improved with experience: durable reduction in MR to ≤2+ at 30 days was achieved in 5 (33.3%) of the first 15 patients and 12 (85.7%) of the last 14 patients.

CONCLUSIONS:

Off-pump transapical implantation of artificial chordae to correct MR is technically safe and feasible; however, it yields further potential for improvement of efficacy and durability. (Safety and Performance Study of the NeoChord Device [TACT]; NCT01777815).

KEYWORDS:

heart disease; mitral valve; surgery

PMID:
24076529
DOI:
10.1016/j.jacc.2013.07.090
[Indexed for MEDLINE]
Free full text

Supplemental Content

Full text links

Icon for Elsevier Science
Loading ...
Support Center