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SternalPlate

Closure. The heart of what we do.

Overview

SternalPlate is a low profile plate and screw system for the stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy, sternal fracture(s) and sternal reconstructions.

Features and benefits

Screw pull-out force compared to industry.1

160% emergency screws

15% self-drilling screws

SternalPlate Screws Chart

Stronger plate stability construct strength compared to industry2

50% stronger in-plane bending

55% stronger out-of-plane bending

SternalPlate Full Set

Ease of use

  • VariSpeed Driver supports self-drilling screw insertion
  • Intuitive module design allows easy access to implants

Varispeed Driver Sternal

Technology

SmartLock

  • Locking plates provide 2 points of fixation designed to provide stability

AXS Screws

  • Promote easy pickup, enhanced off-axis insertion, and reliable locking functionality3

Sternal locking plate angled

Flexibility

  • Modular system allows customization and ease of sterilization

SternalPlate Trays

Clinical evidence

BACKGROUND:

Traditionally, wire cerclage has been used to reapproximate the sternum after sternotomy. Recent evidence suggests that rigid plate fixation for sternal closure may reduce the risk of sternal complications.

METHODS:

The Medline and Embase databases were searched from inception to February 2017 for studies that compared rigid plate fixation with wire cerclage for cardiac surgery patients undergoing sternotomy. Random effects meta-analysis compared rates of sternal complications (primary outcome, defined as deep or superficial sternal wound infection, or sternal instability), early mortality, and length of stay (secondary outcomes).

RESULTS:

Three randomized controlled trials (n = 427) and five unadjusted observational studies (n = 1,025) met inclusion criteria. There was no significant difference in sternal complications with rigid plate fixation at a median of 6 months' follow-up (incidence rate ratio 0.51, 95% confidence interval [CI]: 0.20 to 1.29, p = 0.15) overall, but a decrease when including only patients at high risk for sternal complications (incidence rate ratio 0.23, 95% CI: 0.06 to 0.89, p = 0.03; two observational studies). Perioperative mortality was reduced favoring rigid plate fixation (relative risk 0.40, 95% CI: 0.28 to 0.97, p = 0.04; four observational studies and one randomized controlled trial). Length of stay was similar overall (mean difference -0.77 days, 95% CI: -1.65 to +0.12, p = 0.09), but significantly reduced with rigid plate fixation in the observational studies (mean difference -1.34 days, 95% CI: -2.05 to -0.63, p = 0.0002).

CONCLUSIONS:

This meta-analysis, driven by the results of unmatched observational studies, suggests that rigid plate fixation may lead to reduced sternal complications in patients at high risk for such events, improved perioperative survival, and decreased hospital length of stay. More randomized controlled trials are required to confirm the potential benefits of rigid plate fixation for primary sternotomy closure.

Full Article

BACKGROUND:

Rigid bone fixation is the standard of care for all bone reconstructions except that after sternotomy. Sternal reconstruction after median sternotomy using rigid fixation with plates may improve bone healing and reduce pain when compared with wire cerclage.

METHODS:

One-hundred forty patients at six centers who were determined preoperatively to be at high risk for sternal wound complications were randomly assigned to sternal closure with rigid plate fixation (n=70) or wire cerclage (n=70). Sternal healing was evaluated at 3 or 6 months by a core laboratory using computed tomography. Pain and function were evaluated at postoperative day 3 through discharge, 3 weeks, 6 weeks, 3 months, and 6 months.

RESULTS:

Sternal healing was superior in rigid plate fixation patients at both 3 and 6 months. Mean computed tomography scores in the rigid plate fixation and wire cerclage groups at 3 months were 1.7±1.1 and 0.9±0.8 (p=0.003). At 6 months, the scores were 3.2±1.6 and 2.2±1.1, respectively (p=0.01). At 6 months, 70% of rigid plate fixation patients had achieved sternal union, compared with 24% of conventional wire cerclage patients (p=0.003). Pain scores and narcotic usage were lower in rigid plate fixation patients. Significant differences in pain scores were observed at 3 weeks for total pain (p=0.020) and pain with coughing (p=0.0084) or sneezing (p=0.030). Complication rates were similar in both groups.

CONCLUSIONS:

Sternal reconstruction using rigid fixation with plates improved bone healing and reduced early postoperative pain compared with wire cerclage.

BACKGROUND:

In a multicenter randomized trial, sternal closure after cardiac operations using rigid plate fixation (RPF) compared with wire cerclage (WC) resulted in improved sternal healing, reduced sternal complications, and was cost neutral at 6 months. Additional secondary end points are presented from this trial.

METHODS:

Twelve United States centers randomized 236 patients to RPF (n = 116) or WC (n = 120). Patient-reported outcomes measures, including pain, function, and quality of life scores, were assessed through 6 months and correlated to computed tomography-derived sternal healing scores using logistic regression. Cost analysis through 90 days was performed to mimic bundled care models.

RESULTS:

All patient-reported outcomes measures were numerically better in RPF patients than in WC patients at all assessments. RPF resulted in more patients reporting no sternal pain after coughing at 3 weeks (41.1% vs 19.6%; p = 0.001) and 6 weeks (54.5% vs 35.1%; p = 0.005) and at rest at 6 weeks (74.1% vs 58.8%; p = 0.02) and 3 months (87.6% vs 75.9%; p = 0.03) compared with WC. Better sternal healing scores correlated to having no sternal pain at rest (odds ratio, 1.6; 95% confidence interval, 1.2 to 2.2; p = 0.002) and after coughing (odds ratio, 1.6; 95% confidence interval, 1.2 to 2.2; p = 0.0007). RPF resulted in improvements in the 36-Item Short Form Health Survey quality of life scores at 3 weeks (53.5 ± 8.7 vs 50.5 ± 10.4; p = 0.03), 6 weeks (45.3 ± 8.4 vs 42.7 ± 8.4; p = 0.03), and 6 months (56.4 ± 6.8 vs 53.9 ± 9.0; p = 0.04) compared with WC. Through 90 days, RPF compared with WC was $1,888 less (95% confidence interval, -$8,889 to $4,273; p = 0.52).

CONCLUSIONS:

In patients undergoing sternal closure after median sternotomy, RPF compared with WC resulted in reduced sternal pain, improved upper extremity function, and similar total 90-day costs.

Background:

Postoperative sternal dehiscence with or without mediastinitis is a complication of cardiac surgery leading to considerable disability. Titanium plate fixation can provide sternal stability in patients with a dehiscent sternum. The aim of this study is to compare clinical outcomes of titanium plate fixation with conventional treatment methods such as steel wire cerclage and pectoralis muscle reconstruction. 

Patients and Methods:

A retrospective analysis was performed on 42 patients who underwent sternal refixation after dehiscence or secondary wound closure after poststernotomy mediastinitis. Clinical outcomes during hospital stay and follow-up were determined.

Results:

Twenty patients were closed using sternal plates. Twenty-two patients were closed conventionally: 8 using pectoral muscle reconstruction and 14 using cerclage steel wires. There were no differences in baseline characteristics between the two groups. Indications of sternal closure were similar. Sternal stability at hospital discharge was achieved more often using sternal plating (90 vs. 50%, p = 0.005), mainly in patients closed after treatment of poststernotomy mediastinitis (100 vs. 22%, p = 0.002). Hospital stay was similar in both groups (10 [5-23] vs. 12 (5-21) days, p = 0.527). There was no inhospital mortality.

Conclusion:

Titanium plate fixation is superior in stabilizing the sternal bone when compared with conventional refixation methods, especially in secondary closure after poststernotomy mediastinitis.

BACKGROUND:

The first version of The Society of Thoracic Surgeons National Adult Cardiac Surgery Database (STS NCD) was developed nearly 2 decades ago. Since its inception, the number of participants has grown dramatically, patient acuity has increased, and overall outcomes have consistently improved. To adjust for these and other changes, all STS risk models have undergone periodic revisions. This report provides a detailed description of the 2008 STS risk model for coronary artery bypass grafting surgery (CABG).

METHODS:

The study population consisted of 774,881 isolated CABG procedures performed on adult patients aged 20 to 100 years between January 1, 2002, and December 31, 2006, at 819 STS NCD participating centers. This cohort was randomly divided into a 60% training (development) sample and a 40% test (validation) sample. The development sample was used to identify predictor variables and estimate model coefficients. The validation sample was used to assess model calibration and discrimination. Model outcomes included operative mortality, renal failure, stroke, reoperation for any cause, prolonged ventilation, deep sternal wound infection, composite major morbidity or mortality, prolonged length of stay (> 14 days), and short length of stay (< 6 days and alive). Candidate predictor variables were selected based on their availability in versions 2.35, 2.41, and 2.52.1 of the STS NCD and their presence in (or ability to be mapped to) version 2.61. Potential predictor variables were screened for overall prevalence in the study population, missing data frequency, coding concerns, bivariate relationships with outcomes, and their presence in previous STS or other CABG risk models. Supervised backwards selection was then performed with input from an expert panel of cardiac surgeons and biostatisticians. After successfully validating the fit of the models, the development and validation samples were subsequently combined, and the final regression coefficients were estimated using the overall combined (development plus validation) sample.

RESULTS:

The c-index for the mortality model was 0.812, and the c-indices for other endpoints ranged from 0.653 for reoperation to 0.793 for renal failure in the validation sample. Plots of observed versus predicted event rates revealed acceptable calibration in the overall population and in numerous subgroups. When patients were grouped into categories of predicted risk, the absolute difference between the observed and expected event rates was less than 1.5% for each endpoint. The final model intercept and coefficients are provided.

CONCLUSIONS:

New STS risk models have been developed for CABG mortality and eight other endpoints. Detailed descriptions of model development and testing are provided, together with the final algorithm. Overall model performance is excellent.

Background:

Ministernotomy incisions have been increasingly used in a variety of settings. We describe a novel approach to ministernotomy using arrowhead incision and rigid sternal fixation with a standard sternal plating system.

Methods:

A small, midline, vertical incision is made from the midportion of the manubrium to a point just above the 4th intercostal mark. The sternum is opened in the shape of an inverted T using two oblique horizontal incisions from the midline to the sternal edges. At the time of chest closure, the three bony segments are aligned and approximated, and titanium plates (Sternalock, Jacksonville, Florida) are used to fix the body of the sternum back together.

Results:

This case series includes 11 patients who underwent arrowhead ministernotomy with rigid sternal plate fixation for aortic surgery. The procedures performed were axillary cannulation (n = 2), aortic root replacement (n = 3), valve sparing root replacement (n = 3), and replacement of the ascending aorta (n = 11) and/or hemiarch (n = 2). Thirty-day mortality was 0%; there were no conversions, strokes, or sternal wound infections.

Conclusions:

Arrowhead ministernotomy with rigid sternal plate fixation is an adequate minimally invasive approach for surgery of the ascending aorta and aortic root.

BACKGROUND:

Postoperative mediastinitis is a serious and potentially lethal complication from cardiac surgery. Although postoperative mediastinitis cannot be reliably predicted, a number of preoperative and intraoperative risk factors have been defined by previous work. The authors now present their cumulative experience with primary sternal fixation of high-risk patients as one preventative measure.

METHODS:

A retrospective review from July of 2000 to October of 2006 was performed on 750 patients who had at least three established risk factors for postoperative mediastinitis and received primary titanium plate sternal fixation. Patients were followed for a minimum of 6 weeks and monitored for pain, instability, wound breakdown, and plate migration.

RESULTS:

Rigid plate fixation was completed at the end of the primary cardiac surgical procedure in all 750 patients. Sternal dehiscence occurred in 18 patients (2.4 percent), necessitating reexploration. Four of these patients developed postoperative mediastinitis and had other significant comorbidities, such as ongoing inflammatory breast cancer or pneumonia, that were beyond the typical risk factors identified for developing mediastinitis. Successful sternal fixation was therefore accomplished in 732 patients (97.6 percent). Despite changes in instrumentation and technique, this approach was adopted by the cardiac surgical team consistently after an initial mentoring and training period by the plastic surgeons.

CONCLUSIONS:

Primary sternal fixation is a simple and reliable method for prevention of postoperative mediastinitis development in high-risk patients. This technique, conceptualized by plastic surgeons, is now being implemented by cardiac surgeons in increasing numbers. This demonstrates the ability for plastic surgery to initiate a paradigm shift in other fields of medicine and to decrease the complications that primarily affect our practice.

References:

1: Report_TI5112_SternalPlate - Screw pull-out test

2: Report_TI5112_SternalPlate - Dynamic construct strength

3: K172572 - Performance testing. End user test

CMF-WC-73_Rev. None_24347

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