Prospective Cohort Study on Mid-term Safety and Effectiveness of Minimal Invasive Coronary Artery Bypass Grafting
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- 30 days PCS scores
研究概览
简要总结
CABG technology is recognized as the preferred treatment, and its major adverse cardiac and cerebral event(MACCE) incidence and mortality are lower than percutaneous coronary intervention(PCI). However, the traditional CABG procedure requires sternal incision, large trauma and long recovery period after surgery.
How to reduce trauma and treat multiple complex coronary lesions under minimally invasive conditions has become a hot spot. MIDCAB surgery can complete the coronary anastomosis only by a 6-8 cm incision in the left chest. It has been more than ten years since the first literature report in the world, however, due to the technical bottleneck, a unified and standardized surgical procedure has not yet been formed. Some centers are still in the exploratory stage, and internationally Large-scale studies of clinical outcomes (mostly less than 150 cases) have not been reported. Assessing the minimally invasive procedure's safety and effectiveness has become an urgent problem to be solved.
At present, our center has completed nearly 200 cases of small incision multi-coronary coronary artery bypass graft surgery. The investigators evaluate the patency of the graft by the postoperative of angiography, the patency of grafts is more than 95%, and there is no statistical difference with conventional OPCABG. On the other hand, focus on the postoperative complications, there was no significant difference in the incidence of MACCE and revascularization between the MIDCAB group and conventional surgery during hospitalization. The investigators assume that the early results of this procedure are safe and effective. MIDCAB has a congenital advantage because of its' reduction of the trauma of the thoracotomy and the aesthetics of the incision. Therefore, if a larger sample size study and mid-term follow-up results are obtained, and the conclusion prove that the safety of the small incision surgery and the patency of the grafts are not inferior to conventional surgery. The investigators can consider that minimal invasive coronary surgery(MICS) is a technique worth trying to promote.
Through this prospective cohort study, the investigators evaluated the safety of MICS through mid-term follow-up results and asses the efficiency by the results of grafts patency (angiography or CT within 30 days after surgery) and medical outcomes study-short from scores(SF-36), establish the surgical standard and perioperative management method.
详细描述
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MIDCAB procedure introduction
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Surgery preparation:
General anesthesia, double lumen tracheal intubation. In the supine position, tilt 15° to the right. An automatic defibrillation electrode is attached to the right front and left rear chest wall, and the external defibrillator is connected. A small incision of 8-10 cm into the left anterior lateral 5th intercostal space was performed into the chest. 2. Internal mammary artery acquisition:
After entering the chest, the IMA is exposed through a new minimal invasive retraction system. Single or bilateral IMA is obtained as needed. Separate the IMA From the middle segment (non-fat muscle coverage area) applied with an electric scalpel (15J), and the free range was up to the first rib to the fifth or sixth intercostal(IMA bifurcation). 3. Bypass strategy:
All procedures were performed under a non-cardiopulmonary situation, and vascular anastomosis was performed with the aid of a laparoscopic cardiac stabilizer. The stabilizer is smaller and does not occupy the operating space. The head of stabilizer can be rotated 360 degrees and the target vessel can be fixed at any angle. Bilateral internal mammary artery, radial artery and saphenous vein can be used as graft vessels. The bypass strategy is not particularly different from conventional bypass surgery, including aorta(AO)-saphenous vein graft (SVG) or radial artery(RA)-X1-X2-...( sequential anastomosis), left internal mammary artery(LIMA)-right internal mammary artery(RIMA) -RA or SVG(Y)-X, RIMA-left anterior descending(LAD), LIMA-RA or RIMA or SVG(I)-X1-X2 and so on. 4. Vascular anastomosis:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients are planned for undergoing off-pump coronary artery bypass surgery.
排除标准
- •BMI greater than 28
- •trauma, surgical or radiotherapy history of left chest
- •EF less than 40%
- •Simultaneous other cardiac surgery or planned cardiopulmonary bypass
- •Preoperative critical situation: acute myocardial infarction, heart failure and other conditions require emergency surgery. Preoperative nitrate drugs are difficult to control angina and needs IABP implantation.
- •Respiratory function: severe hypoxemia (pO2 less than 60 mmHg without Oxygen inhalation), carbon dioxide retention (pCO2 > 50 mmHg), severe chronic obstructive pulmonary disease (FEV1/forced vital capacity less than 70% and FEV1 less than 50%)
- •Aortic lesions: patients with ascending aorta calcification confirmed by preoperative CT
- •Peripheral vascular lesions:By the preoperative assessment with ultrasound or CT，LIMA and left subclavian artery stenosis>70% ,or bilateral femoral artery calcification, stenosis>50%
- •Drug therapy: Preoperative antiplatelet or anticoagulant therapy (except aspirin and clopidogrel)
- •Others: Exclusion criteria and contraindications of CABG
结局指标
主要结局
30 days PCS scores
时间窗: 30days after the MIDCAB or OPCABG surgery
PCS scores calculated from the SF-36
Rate of 1 years graft occlusion rate
时间窗: 12 months after the MIDCAB or OPCABG surgery
12 months occlusion rate of graft(Evaluate by angiography of CT angiography )
30 days mental health summary scales(MCS) of SF-36 scores
时间窗: 30days after the MIDCAB or OPCABG surgery
MCS scores calculated from the SF-36
次要结局
- Rate of 30 days graft occlusion rate(within 30days after the MIDCAB or OPCABG surgery)
- MCS scores(7 days, 3 months, 6 months and 12 months after the MIDCAB or OPCABG surgery)
- Rate of Perioperative MACCE(Within 30 days of the MIDCAB or OPCABG surgery)
- PCS scores(7 days, 3 months, 6 months and 12 months after the MIDCAB or OPCABG surgery)
- Rate of mid-term MACCE incidence(12 months after the MIDCAB or OPCABG surgery)