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OBJECTIVE: While titanium fastener technology is gaining acceptance in cardiac surgery, no publications address its use in aortic valve replacement (AVR). This study evaluates the effectiveness, time savings and cost of titanium fasteners used to secure prosthetic aortic valve suture in open cardiac surgery.
METHODS: An ongoing IRB-approved prospective randomized clinical trial was conducted by a single surgeon at one institution. Open AVR surgery patients were randomized to receive either conventional hand-tied knots (HT) or titanium fasteners (TF) to secure prosthetic sutures.
RESULTS: Analyses of 51 subjects (48 completed, 3 withdrawn) demonstrated the groups did not differ significantly in preoperative morbidity, concomitant surgery, AVR size or number of sutures. On average, TF use was faster than HT (23.0 vs. 39.5 sec/knot, p < 0.001; 42% reduction) with 21.0 minutes less in aortic cross clamp (69.0 vs. 90.0 min, p = 0.01; 23%), 26.0 minutes less in cardiopulmonary bypass (87.5 vs. 113.5 min, p = 0.01; 23%) and 42.5 minutes less in overall operative times (235.5 vs. 278.0 min, p = 0.04; 15%). No intraoperative complications occurred with use of TF. No paravalvular leaks, valve dehiscence or fastener embolization occurred. Perioperative complications included: 3 reoperations for bleeding, 4 prolonged ventilator dependence, 1 pneumonia, 2 strokes (HT at 7 days post-op, TF at 12 days) and 1 30-day mortality (TF). Transesophageal echo in both stroke patients confirmed fully functional prosthetic valves and no evidence of thrombus. On cost analysis, the higher average TF operating room (OR) supply costs ($7,857 vs. $7,034; p = 0.01), but lower average OR time costs ($1,927 vs. $2,230; p = 0.05), resulted in no significant difference between the estimated total OR costs for each group ($10,412 vs. $9,892; p = 0.22).
CONCLUSIONS: In this study of open AVR surgery, titanium fastener use is demonstrated as safe, effective and significantly faster than hand-tying. These data also suggest that use of this technology provides operative time savings without significantly increasing OR costs.