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

Area of Science:

• Cardiovascular Surgery
• Medical Devices
• Surgical Techniques

Background:

• The benefits of automated titanium fasteners for sternotomy procedures are not well-established.
• This study evaluates automated fasteners versus manual suturing for annuloplasty fixation.

Purpose of the Study:

• To compare the time and cost efficiency of automated titanium fasteners against conventional hand tying for annuloplasty fixation in sternotomy.
• To assess the impact of automated fasteners on procedural duration and overall surgical costs in mitral or tricuspid valve repair.

Main Methods:

• Fifty patients undergoing mitral or tricuspid ring annuloplasty were randomized into two groups: automated fasteners (n=25) and hand tying (n=25).
• The primary outcome was the time required for annuloplasty device fixation.
• Secondary outcomes included aortic cross-clamp time, cardiopulmonary bypass duration, and total procedure cost.

Main Results:

• Automated fasteners significantly reduced fixation time per stitch for both mitral (22s vs 12s) and tricuspid (20s vs 13s) annuloplasty (p < 0.0001).
• No significant difference was observed in aortic cross-clamp or cardiopulmonary bypass times.
• Total cost for automated fasteners was substantially higher ($1,190 vs $164, p < 0.0001).

Conclusions:

• Automated fasteners provide a small time advantage per suture during annuloplasty fixation.
• The increased device cost associated with automated fasteners outweighs the minimal time savings, making hand tying more cost-effective.
• Automated fasteners did not impact critical procedural times like cross-clamp or bypass duration.