Title: A pragmatic, prospective, randomised controlled trial comparing upper mini-sternotomy to full median sternotomy as a surgical approach for aortic valve replacement (MiniStern Trial).
Funder: Department of Health (England)

Abstract: Background Aortic valve replacement (AVR) is the second most common cardiac surgical procedure in the UK (3436 patients in 2006/07 [1]). Conventionally, AVR is conducted via a full-length median sternotomy, but this approach is frequently associated with considerable post operative pain. Some surgeons have reported benefits for patients after AVR using a mini-sternotomy approach. However, most studies were observational or had small sample sizes and none were conducted in the UK or NHS. We believe that an upper mini-sternotomy approach (MiniStern) will reduce post operative pain and wound complications, hasten postoperative recovery in terms of early mobilisation, reduce length of hospital stay and improve patient satisfaction without compromising the safety or effectiveness of AVR surgery. Aims We intend to conduct a pragmatic prospective randomised controlled trial (RCT) comparing MiniStern to full sternotomy as a surgical approach to first time isolated AVR. Our aims are to determine whether MiniStern can benefit AVR patients by: 1) reducing length of hospital stay; time to first mobilisation; postoperative pain levels; risk of wound infection; postoperative bleeding and number of blood transfusions; 2) maintaining health related quality of life (HRQoL) gain, safety and efficacy of AVR surgery 3) improving post operative respiratory function, wound healing, cosmetic outcome and patient satisfaction. For the wider NHS patient community we aim to determine if it is cost effective to use mini-sternotomy as an alternative to full median sternotomy for isolated AVR surgery. Plan of Investigation This prospective randomised study will enroll patients requiring first time isolated AVR with a mechanical or bioprosthetic valve. Patients will be excluded from the trial if they have poor left ventricular function, chest wall deformities, severe respiratory disease, morbid obesity or require additional cardiac procedures. Patients who give informed consent will be randomised on the day of surgery to either a mini-sternotomy or full median sternotomy surgical approach. Surgeons will convert mini to full sternotomy if required for successful surgery. Patients' clinical and health related quality of life status as well as detailed use of resources, will be assessed at baseline, throughout hospital stay and at 6 weeks, 6 and 12 months post surgery. Potential Impact Research suggests MiniStern AVR may result in less bleeding, greater sternal stability, better respiratory function, less post-operative pain, earlier extubation and earlier hospital discharge than full sternotomy. After AVR, less post-operative discomfort, lower infection rates and earlier mobilisation should be associated with a faster overall recovery and increased patient satisfaction. Cost reductions for the NHS may result from shorter stays on ICU and in hospital and fewer blood transfusions, wound complications, analgesics and antibiotics. Cardiothoracic surgical practice is becoming more and more evidence-based; and we will actively disseminate the results of this RCT, confident that other cardiothoracic surgical units in the UK will adopt the most effective surgical approach.


Research activity codes: 6.4 SURGERY
Health categories: CARDIOVASCULAR