Parasternal vs. Sternotomy Approach for Conventional Aortic Valve Replacement
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Quality of life - physical function
研究概览
简要总结
Prospective randomized study comparing aortic valve replacement using parasternal or sternotomy access with regard to quality of life and systemic inflammatory reaction.
详细描述
The classic surgical treatment of aortic stenosis is valve replacement through complete midline opening of the breastbone (median sternotomy) and use of cardiopulmonary bypass (CPB). Risks of this procedure are related to both the surgical approach and the use of CPB. Using minimally invasive approaches in non-cardiac patients (e.g laparoscopy) resulted in reduced postoperative inflammatory response when compared to patients undergoing the same procedures carried out with a conventional "open" technique. Minimally invasive surgical approaches in which the sternum is partially opened (partial sternotomy) or not opened at all (parasternal access) have thus far shown similar procedure related mortality and lower incidence of perioperative complications, despite longer CPB times. Our single center experience thus far suggests superiority of parasternal aortic valve replacement (O/E ratio of 0.19 over the last 2 years), as well as a reduced postoperative inflammatory response (as measured by lower CRP (C reactive protein ) levels taken 6 hours post-surgery). However, these data have several confounders and there is currently no prospective randomized trial addressing this topic. We therefore conduct a randomized comparison of parasternal versus classic sternotomy aortic valve replacement. Based on our previous experience, we expect very low mortality risk in both groups (expected ≤ 1%). The primary endpoint is therefore quality of life assessed using the SF-36 (Short Form) health survey questionnaire. This approach is similar to other current large multicenter trials. In order to address the impact of reduced surgical trauma on inflammatory response; we will quantify an established panel of inflammatory markers (PCT, CRP, interleukin 6) and use bio-banking to allow for further in depth analysis later on. Standardized clinical endpoints will be analyzed as additional secondary parameters. Power analysis determined a number of 50 patients allocated to 2 equal groups to achieve a power of 80%. The parasternal approach is expected to be superior when compared to sternotomy in both the primary and some, if not most, secondary endpoints. We expect our study to become an important milestone for decision-making in the treatment of aortic stenosis. Patients currently fear sternotomy, but the less invasive transcatheter valve implantation appears to be limited by inferior long-term outcome. The parasternal, sternotomy-sparing, classic aortic valve replacement is therefore an attractive therapeutic alternative. Our investigation in relation to systemic inflammatory response will further shed light on the underlying mechanisms explaining differences in clinical outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication for elective isolated aortic valve replacement
- •Anatomical suitability for both sternotomy and parasternal access
- •Written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
排除标准
- •Planned simultaneous cardiac surgery interventions (Mitral valve surgery, tricuspid valve surgery, CABG, Pacemaker or defibrillator implantation, Pulmonalvenenisolation, Maze, closure of left atrial appendage , patent foramen ovale or atrial septal defect closure)
- •Acute myocardial infarction within 4 weeks, coronary heart disease
- •Acute endocarditis
- •TIA or stroke within 6 months prior to the procedure
- •Pregnant or breast-feeding women
- •Renal failure requiring dialysis
- •Ejection fraction ≤ 30%
- •Re-operation
- •Disease with a life expectancy < 2 years
- •Therapy with glucocorticoids or immunosuppressants
结局指标
主要结局
Quality of life - physical function
时间窗: 30 days after surgery
Comparison of the physical quality of life between the two groups 30 days after surgery using the physical function score of the 36-Item Short Form Health Survey (SF-36). The physical function score is a scale from 0 (poor physical function) to 100 (excellent physical function, with an average score of 50. It includes items that assess physical functioning, bodily pain, physical role functioning, vitality, and generaly health perceptions.
次要结局
- Duration of cardiopulmonary bypass(During the aortic valve replacement surgery)
- Duration of aortic clamping(During the aortic valve replacement surgery)
- Duration of the Operation(During the aortic valve replacement surgery)
- Blood transfusion(From the time of surgery until the patient is discharged from hospital, an average of 7 days)
- Rethoracotomy for bleeding(From the time of surgery until the patient is discharged from hospital, an average of 7 days)
- Atrial fibrillation(From the time of surgery until the patient is discharged from hospital, an average of 7 days)
- Inflammatory markers: Procalcitonin, C-reactive protein, Interleukin-6(During the first 48 hours after surgery)
- Post-operative pain(From the time of surgery until the patient is discharged from hospital, an average of 7 days)
- Mortality(During the first 30 days after surgery)
- Quality of Life - mental function(30 days after surgery)
- Major Adverse Cardiac and Cerebrovascular Events (MACCE)(From the time of surgery until the patient is discharged from hospital, an average of 7 days)
- Duration of mechanical ventilation(Measured from the time of arrival in the Intensive Care Unit until the time patients are extubated, an average of 12 hours)
- Length of ICU stay(From the time of surgery until the patient is discharged from hospital, an average of 30 days)
- Length of hospital stay(From the time of surgery until the patient is discharged from hospital, an average of 30 days)
- Wound infection(During the first 30 days after surgery)