Prospective evaluation of a new sternal closure method with thermoreactive clips

The role of the sternal closure techniques on the incidence of sternal dehiscence and wound infection are well defined among a high number of other variables involved. In the various series, the incidence of wound complication in cardiac surgery varies from 2 to 8%. The aim of our study is to evaluate the role of thermal-dependent shape-memory Nitillium clips in reducing the incidence of sternal dehiscence following sternotomy.

We perspectively randomized 1000 consecutive patients requiring cardiac surgery to evaluate the incidence of sternal wound complications (SWC), sternal dehiscence and/or other related complications. We compared Group I (500 patients), in which sternal closure was achieved with standard sternal wires, with Group II (500 patients), in which sternal approximation was carried out by means of thermoreactive Nitillium clips. The two randomized groups were comparable in terms of age, gender, Euroscore and risk factors for sternal/wound complications.

In our study the overall incidence of SWC was 4.7%. The incidence of SWC was considerably higher in Group I (6.8%) when compared to Group II (2.6%) (P=0.003). Mechanical sternal dehiscence without infection occurred in 14 patients in Group I and in one patient in Group II (P=0.002). Despite sternotomy wound infection occurred similarly in both groups (15 patients in Group I vs. 12 patients in Group II), sternal revision was performed only in patients of Group I (Group I: 9/15 vs. Group II: 0/12; P=0.001).

Thermal shape-memory Nitillium clips provided superior results in sternal osteosynthesis following midline sternotomy, due to a considerable reduction of sternal dehiscence and related complications. The clinical benefit of Nitillium clips was demonstrated even in patients with several risk factors for SWC.