BackgroundThe main objective of this study will be to determine the effects of a new advanced sternum external fixation (Stern-E-Fix) corset on prevention of sternal instability and mediastinitis in high-risk patients.MethodsThis prospective, randomized study (January 2009 – June 2011) comprised 750 male patients undergoing standard median sternotomy for cardiac procedures (78% CABG). Patients were divided in two randomized groups (A, n = 380: received a Stern-E-Fix corset postoperatively for 6 weeks and B, n = 370: control group received a standard elastic thorax bandage). In both groups, risk factors for sternal dehiscence and preoperative preparations were similar.ResultsWound infections occurred in n = 13 (3.42%) pts. in group A vs. n = 35 (9.46%) in group B. In group A, only 1 patient presented with sternal dehiscence vs. 22 pts. in group B. In all 22 patients, sternal rewiring followed by antibiotic therapy was needed. Mediastinitis related mortality was none in A versus two in B. Treatment failure in group B was more than five times higher than in A (p = 0.01); the mean length of stay in hospital was 12.5 ± 7.4 days (A) versus 18 ± 15.1 days (B) (p=0.002). Re-operation for sternal infection was 4 times higher in group B. Mean ventilation time was relatively longer in B (2.5 vs. 1.28 days) (p = 0.01). The mean follow-up period was 8 weeks (range 6 – 12 weeks).ConclusionsWe demonstrated that using an external supportive sternal corset (Stern-E-Fix) yields a significantly better and effective prevention against development of sternal dehiscence and secondary sternal infection in high-risk poststernotomy patients.

2D strain parameters of the RV free wall seem to be auspicious for RV function and predicting RHF. Moreover, intraoperative CVP should not be neglected since elevated values proved to be highly associated with RHF. Our results represent a valuable supplement to other scores by considering both echocardiography and intraoperative data.

In right ventricular failure (RVF) a decrease of right ventricular afterload and improvement of left atrial filling could be achieved by a pulmonary artery-left atrial (PA)-shunt. To avoid cyanosis, artificial oxygenation is necessary. In 11 pigs a PA-shunt was created. An interventional lung assist device (ILA) was installed from the femoral artery to vein in 5 pigs (serial in relation to native lung: Group I) and into the PA-shunt in 6 pigs (parallel: Group II). RVF was induced by pulmonary artery banding. Right ventricular performance was determined by pulse contour analysis, pressure - and flow measurements. In both groups a stable RVF was generated. In Group I cardiac output trended to increase but neither right ventricular filling pressures nor arterial pressure changed significantly. The PaO2 decreased significantly. In Group II cardiac output and arterial pressure increased significantly under a shunt flow of 2.3- 2.6 l/min and the animals recovered from cardiogenic shock. In conclusion a PA-shunt with a parallel lung assist can effectively reverse the deleterious effects of RVF.

Tricuspid valve regurgitation mostly occurs as result of dilation of the right ventricle, secondary to left heart valve diseases. Until recently, little attention has been given to the development of percutaneous therapeutic tools exclusively designed for tricuspid valve disease. A new approach to the interventional therapy of tricuspid regurgitation, in particular, the design of a conceptual new valve-bearing, self-expansible stent, is presented here. A three-dimensional computer model of a right porcine heart was developed to gain a realistic anatomical geometry. The new design consists of two tubular stent elements, one inside the superior vena cava and the other inside the tricuspid valve annulus after being eventually equipped with a biological valve prosthesis, which are connected by struts. Anchoring to the heart structure is provided primarily by the vena cava stent, strengthened by the struts. The stents are designed to be cut from a 10 mm tube and later expanded to their designated diameter. Simulation software analyzing the expansion process with respect to the intended geometrical design is used in an iterative process. A validation of the anatomical geometry and function of the stent design inside a silicone model within in vitro tests and a random porcine heart shows an accurate anatomical fitting.

We demonstrated the feasibility in principle of a personalized interventional treatment for tricuspid regurgitation using a braided stent, based on individual cardiac imaging, with anchoring forces mainly exerted on the venae cavae and on the inner surface of the right atrium. The design process of this device is a good indicator of the growing potential of an imaging-based personalized simulation and production approach for the treatment of tricuspid valve disease.