Automated Titanium Fasteners Versus Hand-Tied Knots: A Randomized Controlled Trial.

BACKGROUND

The relative benefits of automated titanium fasteners (LSI Solutions, Victor, NY) have not been examined in patients undergoing sternotomy. The aim of this study was to assess the time and cost required for suture fixation with the automated device versus conventional hand tying in sternotomy for mitral or tricuspid ring annuloplasty.

METHODS

Fifty patients scheduled to undergo primary mitral or tricuspid, or both, ring annuloplasty-based valve repair operation by a single surgeon were randomly assigned to receive either conventional hand-tied knots or automated titanium fasteners, with 25 patients in each group. The primary outcome variable was the time required to affix the annuloplasty device to the valve annulus.

RESULTS

The times taken to affix a mitral annuloplasty band or ring were 6.1 ± 0.9 min for manual tying versus 3.1 ± 0.4 min for automated fasteners (p < 0.0001); when calculated per annuloplasty stitch, the values were 22 ± 2 s versus 12 ± 1.1 s, respectively (p < 0.0001). The corresponding values for tricuspid annuloplasty were 4.2 ± 1.2 min (hand tying) versus 2.2 ± 0.3 min (automated fasteners) (p = 0.0005), and the times for each suture were 20 ± 2.1 s versus 13 ± 2 s, respectively (p = 0.0004). The use of the automated fastener had no significant impact on aortic cross-clamp time or cardiopulmonary bypass duration. Total cost associated with annuloplasty fixation with automated titanium fasteners (device cost in addition to operating room time cost) was significantly higher than with hand tying ($1,190 ± 374 vs $164 ± 60; p < 0.0001).

CONCLUSIONS

Using the automated fastener to facilitate annuloplasty fixation through a sternotomy resulted in a small procedural time savings (average of 10 s/stitch) that had no overall impact on cardiopulmonary bypass or cross-clamp times but added an average cost of $1,026 to the operation.