Off-pump transapical implantation of artificial neo-chordae to correct mitral regurgitation: the TACT Trial (Transapical Artificial Chordae Tendinae) proof of concept.
OBJECTIVE
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).
Department of Cardiac Surgery, Heartcentre Leipzig, Leipzig, Germany. Electronic address: joerg.seeburger@medizin.uni-leipzig.de.
Joerg
J
Seeburger
Clinic for Cardiac Surgery, University of Turin, Turin, Italy.
Mauro
M
Rinaldi
Department of Cardio-thoracic and Vascular Surgery, Aarhus University, Aarhus, Denmark.
Sten Lyager
SL
Nielsen
Clinic for Cardiac Surgery, University of Turin, Turin, Italy.
Stefano
S
Salizzoni
Department of Cardiac Surgery, German Heart Centre, Munich, Germany.
Ruediger
R
Lange
Department of Cardiac Surgery, Kerckhoff Klinik, Bad Nauheim, Germany.
Markus
M
Schoenburg
Department of Cardiac Surgery, St. Raffaelo Hospital, Milan, Italy.
Ottavio
O
Alfieri
Department of Cardiac Surgery, Heartcentre Leipzig, Leipzig, Germany.
Michael Andrew
MA
Borger
Department of Cardiac Surgery, Heartcentre Leipzig, Leipzig, Germany.
Friedrich Wilhelm
FW
Mohr
Department of Cardiac Surgery, Vilnius University, Vilnius, Lithuania.
Audrius
A
Aidietis
D000368:Aged; D002404:Catheterization; D002815:Chordae Tendineae / Q000601:surgery; D004867:Equipment Design; D005260:Female; D006350:Heart Valve Prosthesis / Q000009:adverse effects*; D019918:Heart Valve Prosthesis Implantation / Q000295:instrumentation / Q000379:methods*; D006801:Humans; D008297:Male; D008875:Middle Aged; D008943:Mitral Valve / Q000601:surgery; D008944:Mitral Valve Insufficiency / Q000601:surgery*; D008945:Mitral Valve Prolapse / Q000601:surgery*; D061214:Patient Safety; D011446:Prospective Studies; D012086:Reoperation; D013536:Suture Techniques / Q000295:instrumentation
heart disease; mitral valve; surgery