Advice
Clinical and technical evidence
Clinical and technical evidence
A literature search was carried out for this briefing in accordance with the published process and methods statement. This briefing includes the most relevant and best publicly available evidence relating to the clinical and cost effectiveness of the technology. The literature search strategy, evidence selection methods and detailed data extraction tables are available on request by contacting mibs@nice.org.uk
Published evidence
This briefing summarises 5 studies, including a total of 233 patients. The studies consist of 1 randomised trial (Bennett-Guerrero 2011) and 4 case series (DeLong 2014, Kumar 2012, Levin 2010 and Muller 2010).
Bennett-Guerrero (2011) randomised 52 patients to either Sternal Talon with wires (n=28) or wires only (n=23). The outcomes trend towards favouring Sternal Talon, but no statistically significant differences were found. DeLong (2014) comprises 24 cases, retrospectively analysed, in patients that had a failed wire closure after sternotomy. The Kumar (2012) poster abstract describes a 188‑patient retrospective case series, in patients at high risk for sternotomy complications. The Levin (2010) study was a retrospective case series with 42 high‑risk patients across 8 US sites. This study used Sternal Talon alone for closure. The Muller (2010) conference abstract describes a 16‑patient case series in high‑risk patients, which used Sternal Talon with additional wires for stability, if needed.
Table 2 summarises the clinical evidence as well as its strengths and limitations.
Strengths and limitations of the evidence
Overall, the evidence base for Sternal Talon shows that it can be a safe and effective option for sternal closure, whether used alone or with additional sternal wires for stability. The evidence indicates that this may be most applicable for patients at increased risk of complications, such as people with previous wire‑closure failures or patients with obesity, diabetes or chronic obstructive pulmonary disease.
The strengths of the evidence base are that there is 1 randomised trial and some large case series. None of the included studies reported any major complications arising from the use of Sternal Talon.
However, there is very little comparative evidence with standard care. Some of the studies used Sternal Talon alone and some used it with wire closure, and this may have affected the outcomes. The randomised trial was a small pilot study and the authors concluded that a larger follow-on study is needed to improve the evidence base for Sternal Talon. Two of the studies (Kumar 2012 and Muller 2010) are reported as abstracts, and so details of the studies are limited.
Table 2: Study overviews
|
Study size, design and location |
Intervention and comparator(s) |
Outcomes |
Strengths and limitations |
|
51 patients Randomised controlled trial 2 sites US |
Cardiac surgical patients at higher risk of sternal wound complications. Talon n=28 (also with wires). Wires n=23. |
Talon patients had a higher percentage of preoperative incentive spirometry than the wire closure patients, lower use of opiates, increased mobility at day 5 post-op, needed fewer days on a ventilator and had a shorter length of stay. None of these outcomes were statistically significant. |
Strengths: Robust comparative study design. Limitations: This was a small pilot study funded by manufacturer. One author stated that they received royalties indirectly through sales of the Talon device. |
|
24 patients Retrospective case series 2 sites US |
Sternal Talon repair for sternal nonunion or acute mediastinitis, or both, after failed sternal wire closure. |
Sternal union achieved in all but one case. 16/24 patients had no complications. Subsequent reoperation was needed in 4 cases (1 patient had a haematoma and 3 patients needed Talon device removal – 2 because of infection, 1 because of implant exposure after sternal closure). |
Strengths: Demonstration of efficacy in patients with previously failed wire closure. Limitations: This was a small case series with no control group. The study was retrospective, so follow-up was variable between cases and based upon events occurring. |
|
188 patients Retrospective case series 1 site US |
Patients at high risk for sternotomy complications. |
No device-related complications were observed. One postoperative death occurred which was not device-related. Three patients had devices removed after 3 to 6 months because of discharging sinus. Three patients had minor superficial wound problems. |
Strengths: The study a large number of case studies. Limitations: The study was retrospective and reported as a poster abstract only, with very few methodological or result details reported. |
|
42 patients Retrospective case series 8 sites US |
Midline sternotomy in high-risk patients, using Sternal Talon. |
No wound infections or dehiscence, nonunions, or returns to the operating room were observed. Three deaths occurred which were not device-related. There were no reported problems with computed tomographic scatter or chest roentgenogram visualisation. |
Strengths: This was a relatively large case series across 8 sites. Limitations: Reported results are quite brief in this efficacy and safety study. One author stated that they received royalties indirectly through sales of Sternal Talon. |
|
16 patients Case series 1 site Germany |
Primary sternotomy using Sternal Talon for closure (with wires if needed). High-risk patients (obese, patients with diabetes, patients with COPD). |
Successful placement of the talons was achieved in all patients. 3 staphylococci infections occurred which were treated successfully. No other complications were reported. |
Strengths: the study provided a demonstration of efficacy in patients at high risk of mediastinitis. Limitations: the study was published as a conference abstract and methodological and result details were lacking. |
Recent and ongoing studies
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DRKS00000697 – COSTA: Closure of median sternotomy in high-risk patients with the Sternal Talon system. Recruitment: 250 patients. Randomised, international multicentre trial. Status: recruitment and follow‑up complete, study closed 02/05/2014.