Heart Rehabilitation in patients awaiting Open heart surgery targeting to prevent Complications and to improve Quality of life (Heart-ROCQ): study protocol for a prospective, randomised, open, blinded endpoint (PROBE) trial.

INTRODUCTION: The rising prevalence of modifiable risk factors (eg, obesity, hypertension and physical inactivity) is causing an increase in possible avoidable complications in patients undergoing cardiac surgery. This study aims to assess whether a combined preoperative and postoperative multidisciplinary cardiac rehabilitation (CR) programme (Heart-ROCQ programme) can improve functional status and reduce surgical complications, readmissions and major adverse cardiac events (MACE) as compared with standard care. METHODS AND ANALYSIS: Patients (n=350) are randomised to the Heart-ROCQ programme or standard care. The Heart-ROCQ programme consists of a preoperative optimisation phase while waiting for surgery (three times per week, minimum of 3 weeks), a postoperative inpatient phase (3 weeks) and an outpatient CR phase (two times per week, 4 weeks). Patients receive multidisciplinary treatment (eg, physical therapy, dietary advice, psychological sessions and smoking cessation). Standard care consists of 6 weeks of postsurgery outpatient CR with education and physical therapy (two times per week). The primary outcome is a composite weighted score of functional status, surgical complications, readmissions and MACE, and is evaluated by a blinded endpoint committee. The secondary outcomes are length of stay, physical and psychological functioning, lifestyle risk factors, and work participation. Finally, an economic evaluation is performed. Data are collected at six time points: at baseline (start of the waiting period), the day before surgery, at discharge from the hospital, and at 3, 7 and 12 months postsurgery. ETHICS AND DISSEMINATION: This study will be conducted according to the principles of the Declaration of Helsinki (V.8, October 2013). The protocol has been approved by the Medical Ethical Review Board of the UMCG (no 2016/464). Results of this study will be submitted to a peer-reviewed scientific journal and can be presented at national and international conferences. TRIAL REGISTRATION NUMBER: NCT02984449.

Cardiac rehabilitation for patients having cardiac surgery: a systematic review.

INTRODUCTION: Cardiac rehabilitation (CR) is recommended for all cardiac patients including patients after cardiac surgery. Since the effect of CR after cardiac surgery has not been well established yet, we conducted a systematic review on the effects of CR for patients after cardiac surgery compared to treatment as usual. EVIDENCE ACQUISITION: A systematic review of randomized clinical trials (RCTs), quasi-randomized and prospective observational studies in The Cochrane Library, PubMed/MEDLINE and EMBASE was undertaken until October 18th, 2017. Adults after any kind of cardiac surgery were included. Primary outcome was all-cause mortality, other outcomes were serious adverse events, health-related quality of life, work participation, functioning and costs/cost-effectiveness. Risk of bias was evaluated, and the quality of evidence was assessed by the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) criteria. EVIDENCE SYNTHESIS: Eighteen RCTs and 15 observational studies were included. Low risk of bias was only observed in one observational study. Meta-analysis of RCTs suggested no significant difference of CR compared to control on mortality (random-effects relative risk (RR) 0.93 (95% CI: 0.40-1.81), while observational studies suggested statistically significant beneficial effect associated with CR (random-effects RR=0.49, 95% CI: 0.35 - 0.68). CR did not significantly affect any of the other outcomes. Due to the limited data TSA could not be performed. CONCLUSIONS: The body of evidence does not allow us to reach any reliable conclusions about the effectiveness of CR following cardiac surgery. Future trials need to be conducted with low risks of bias and clearly defined outcomes.

A new beating-heart mitral and aortic valve assessment model with implications for valve intervention training.

Objectives: A thorough understanding of mitral and aortic valve motion dynamics is essential in mastering the skills necessary for performing successful valve intervention (open or transcatheter repair or replacement). We describe a reproducible and versatile beating-heart mitral and aortic valve assessment and valve intervention training model in human cadavers. Methods: The model is constructed by bilateral ligation of the pulmonary veins, ligation of the supra-aortic arteries, creating a shunt between the descending thoracic aorta and the left atrial appendage with a vascular prosthesis, anastomizing a vascular prosthesis to the apex and positioning an intra-aortic balloon pump (IABP) in the vascular prosthesis, cross-clamping the descending thoracic aorta, and finally placing a fluid line in the shunt prosthesis. The left ventricle is filled with saline to the desired pressure through the fluid line, and the IABP is switched on and set to a desired frequency (usually 60-80 bpm). Prerepair valve dynamic motion can be studied under direct endoscopic visualization. After assessment, the IABP is switched off, and valve intervention training can be performed using standard techniques. Results: This high-fidelity simulation model has known limitations, but provides a realistic environment with an actual beating (human) heart, which is of incremental value. The model provides a unique opportunity to fill a beating heart with saline and to study prerepair mitral and aortic valve dynamic motion under direct endoscopic visualization. Conclusions: The entire set-up provides a versatile beating-heart mitral and aortic valve assessment model, which may have important implications for future valve intervention training.

Hospital Costs Of Extracorporeal Life Support Therapy.

OBJECTIVES: To conduct an exploration of the hospital costs of extracorporeal life support therapy. Extracorporeal life support seems an efficient therapy for acute, potentially reversible cardiac or respiratory failure, when conventional therapy has been inadequate, or as bridge to transplant, but unfortunately, no evidence in randomized controlled trials is delivered yet. DESIGN: Single-center retrospective exploratory cohort cost study. The study is performed from a hospital perspective with a time horizon of patients' complete hospital admission in which they received extracorporeal life support. SETTING: ICU of a university teaching hospital in The Netherlands. PATIENTS: All 67 consecutive adult patients who were admitted to the ICU of the University Medical Center Groningen in the period 2010-2013 and received extracorporeal life support treatment. INTERVENTION: None. MEASUREMENTS AND MAIN RESULTS: The bottom-up microcosting method was used except when stated otherwise. Medical costs were estimated by multiplying every registered healthcare consumption with unit prices. Unit prices were largely based on Dutch reference prices. For each patient, the personnel costs and material costs were assessed in detail. The costs of extracorporeal life support were differentiated in costs of procedures and costs of daily surcharge of therapy. Procedure-related costs were subdivided in costs of devices and disposables, costs of additional human resources, and surgery hours. The mean total hospital costs were € 106.263 (€ 83.841 to € 126.266) per patient ($145,580). On average, 52% of the total costs arose from hospital nursing days and 11% of direct procedure-related extracorporeal life support costs. Surgery and diagnostics represented a vast amount of the remaining costs. CONCLUSIONS: This large and detailed economic evaluation of hospital costs of extracorporeal life support therapy in the Netherlands showed that mean total hospital cost of extracorporeal life support treatment is € 106.263 per patient. The majority of the costs are composed of nursing days.