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Abstract Background The 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. Methods This 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. Results Wound 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). Conclusions We 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.

Abstract Background Right ventricular failure (RVF) and -support is associated with poor results. We aimed for a new approach of right - sided assistance bypassing the right ventricle and pulmonary circulation in order to better decompress the right ventricle and optimize left ventricular filling. Methods From a microaxial pump (Abiomed), a low resistance oxygenator (Maquet and Novalung) and two cannulas (28 and 27 Fr) a system was set up and evaluated in an ovine model (n = 7). Connection with the heart was the right and left atrium. One hour the system was operated without RVF and turned of again. Then a RVF was induced and the course with the system running was evaluated. Complete hemodynamic monitoring was performed as well as echocardiography, flow measurement and blood gas analysis. Results The overall performance of the system was reliable. Without RVF no relevant changes of hemodynamics occurred; blood gases were supra normal. In RVF a cardiogenic shock developed (MAP 35 ± 13 mmHg, CO 1,1 ± 0,7 l/min). Immediately after starting the system the circulation normalized (significant increase of MAP to 85 ± 13 mmHg, of CO to 4,5 ± 1,9). Echocardiography also revealed right ventricular recovery. After stopping the system, RVF returned. Conclusions Bypassing the right ventricle and pulmonary circulation with an oxygenating assist device, which may offer the advantages of enhanced right ventricular decompression and augmented left atrial filling, is feasible and effective in the treatment of acute RVF. Long time experiments are needed.

Introduction: Right ventricular failure (RVF) on its own is a life-threatening condition. Often it manifests as a two-organ failure in the final phase of several lung diseases. Mechanical circulatory support is a proven treatment of RVF but remains challenging. Our objective is to develop a novel, simplified, and minimally invasive cannula approach to treat both RVF and respiratory failure. Methods: We conceptualized a dual lumen cannula approach to allow oxygenated right-to-left shunting at an atrial level to decompress right-sided circulation. A minimally invasive approach through percutaneous, transjugular insertion and transseptal placement should enable patients to be non-sedated and even ambulatory. In an iterative design, pre-prototyping, prototyping, and anatomic fitting process, such a cannula was generated and tested in both cadaveric and fluid dynamic studies. Results: After various modifications and improvements, a 27-Fr 255-mm-long double-lumen cannula with an inner line (oxygenated blood return to patient into the left atrium) of 18 Fr and an inflatable balloon (with a volume of approximately 1 mL) at the outflow tip was produced – one version with a straight head and another one with a curved head. In our anatomic studies, the "Aachen Cannula" allowed an easy transjugular introduction and advancement into the right atrium by Seldinger technique. Transseptal placement was achieved by puncture (Brockenbrough needle) in combination with dilatation and was then secured in place with the stabilizing balloon, even under slight tension. The cannula prototype enabled a flow of up to 3.5 L/min, at which common pressure drops were observed. Conclusion: In conclusion, we successfully conceptualized, designed, and verified a minimally invasive one-cannula approach for the treatment of either isolated right heart failure and even combined RVF and respiratory failure through our transseptal Aachen Cannula. This concept may also be carried out in ambulatory conditions. Moreover, this approach completely avoids recirculation issues and ensures reliable oxygenated coronary as well as cerebral perfusion. [ABSTRACT FROM AUTHOR]

Noninvasive measurements of blood pressure (BP) and cardiac output (CO) are crucial in the follow‐up of continuous‐flow left ventricular assist device (CF‐LVAD) patients. For our pilot study, we sought to compare BP measurements between a tonometry blood pressure pulse analyzer (BPPA) (DMP‐Life, DAEYOMEDI Co., Ltd., Gyeonggi‐do, South Korea) and Doppler ultrasound in CF‐LVAD patients, as well as to compare the BPPA estimated CO to LVAD calculated blood flow and to the patient's intrinsic CO estimated with transthoracic echocardiography (TTE). Ambulatory CF‐LVAD patients (6 HeartMate, 26 HeartMate II), were included. According to TTE findings, patients were then subdivided in two groups: patients with an opening aortic valve (OAV) [n = 21] and those with an intermittent opening aortic valve (IOAV) [n = 11]. We found a very good correlation of systolic BP (SBP) measurements between the two methods, BPPA and Doppler ultrasound (r = 0.87, P < 0.0001). Bland‐Altman plots for SBP revealed a low bias of −4.6 mm Hg and SD of ±4.7 mm Hg. In CF‐LVAD patients with IOAV, the BPPA‐CO had a good correlation with the LVAD‐flow (r = 0.78, P < 0.0001), but in OAV patients, there was no correlation. After adding the patient's intrinsic CO, estimated from TTE in patients with OAV to the LVAD‐flow, we found a very good correlation between the BPPA‐CO and LVAD‐flow + TTE‐CO (r = 0.81, P = 0.002). Our study demonstrated that compared with the standard clinical method, Doppler ultrasound, the BPPA measured BP noninvasively with good accuracy and precision of agreement. In addition, tonometry BPPA provided further valuable information regarding the CF‐LVAD patient's intrinsic CO. [ABSTRACT FROM AUTHOR]