Safety and Efficacy of Multivessel Minimally Invasive Coronary Artery Bypass Graft Surgery

Ischemic Heart Disease Clinical Trial

Official title:

Safety and Efficacy of Multivessel Minimally Invasive Coronary Artery Bypass Graft Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03247855
• Other study ID #: 17200098
• Status: Not yet recruiting
• Phase: N/A
• First received: July 30, 2017
• Last updated: August 9, 2017
• Start date: September 1, 2017
• Est. completion date: October 1, 2019

Study information

• Verified date: August 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

the aim of this study is to evaluate safety and efficacy of multivessel minimally invasive coronary artery bypass graft surgery through evaluating the possibility of reaching complete revascularization , the complications during surgery and the outcomes

Description:

Minimally invasive direct coronary artery bypass (MIDCAB) grafting can achieve adequate coronary artery revascularization in a less invasive manner than conventional coronary artery bypass grafting (CABG). Bypass from the internal mammary artery (IMA) to the left anterior descending coronary artery (LAD) is an effective technique for the treatment of simple anterior descending artery disease. This surgery is especially recommended for patients with multiple lesions that are not suitable for stent stenosis . One of the main advantages of MIDCAB is that there is no need for cardiac arrest and cardiopulmonary bypass (CPB) transfer during surgery . MIDCAB patients also benefit from the neurological protection associated with this minimally invasive procedure . Unlike traditional revascularization techniques, which are highly invasive due to the use of a large incision (sternotomy) and cardiopulmonary bypass (CPB), MIDCAB limits invasiveness by operating through a small incision (thoracotomy) and by operating on the beating heart to avoid the need for CPB . By limiting invasiveness in these ways, MIDCAB can reduce the risk of complications such as infection and stroke . In comparison to traditional CABG and off-pump CABG (via a sternotomy), MIDCAB can enhance early post-operative quality of life and recovery time . Minimally invasive multivessel coronary surgery-coronary artery bypass grafting (MICS-CABG) through a small thoracotomy has many advantages over minimally invasive direct coronary artery bypass (MIDCAB). First, MIDCAB is limited to a single anastomosis of the left internal mammary artery to the left anterior descending artery (LIMA-LAD). The surgical exposure of MICS-CABG is done more laterally, leading to reduced risk of costochondral or rib injury. Also, MICS-CABG allows revascularization with a similar configuration to that of a traditional sternotomy technique, by direct-vision LIMA harvesting and hand-sewn proximal and distal anastomoses . MICS may be performed with or without cardiopulmonary bypass (CPB) assistance, but the use of femorofemoral CPB in multivessel revascularization has shown to be safe, mitigate the learning curve, prevent conversions, and allows operative time like that of a sternotomy. ]. Other advantages include a diminished need for blood transfusion, decreased surgical site infection rates, also early return to full physical function .

On the other hand complications include sternotomy conversion and development of left-sided pleural effusion . Postoperative pain can be an issue early, but it is transient, controllable, and significantly decreased by the third postoperative day; it is also associated with an overall improved postoperative pain picture with improved pulmonary functions . However, unlike sternotomy patients, MICS-CABG patients have no physical restriction postoperatively, which leads to better independence.

This study aim to evaluate Safety and efficacy of multivessel minimally invasive coronary artery bypass graft surgery through measuring several factors such as

1. measuring rate of intraoperative complications occurrence

2. measuring rate of intraoperative conversion to open sternotomy

3. measuring amount of post operative bleeding

4. measuring post operative pain

5. measuring rate of reexploration

6. measuring rate of wound infection

7. calculating days of postoperative hospital stay

8. calculating time to regain normal activity

The information gathered from the eligible patients will be entered into a data sheet containing the variables of interest that will be analyzed later at the end of the study. This study will not alter the patients' treatment and follow up at our center, by any means.

The following variables will be studied whenever applicable and whenever they are available in the patients' charts:

1. Demographic data: (Medical Record Number ,Sex ,Age Other comorbidity)

2. Preoperative variables : (chest pain , dyspnea ,ECG findings ,Myocardial markers and cardiac troponin ,Cardiac Angiography )

3. Operative variables: (Conversion to sternotomy. , Cardiac arrest ,Operation time ,Need for IABP, CPB ,Need for blood transfusion)

4. Postoperative variables: (Mortality , Bleeding , Pain , Need of reexploration , Hospital stay , Wound infection , Regain of normal activity , Relief of symptoms , Need for another revascularization within 6 month)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 1, 2019
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age 18 or more

2. Angiographically Indication for revascularization based upon symptoms of angina and/or objective evidence of myocardial ischemia

3. Suitable minimally invasive coronary surgery (MICS) candidate for non-emergent first time, single or multivessel coronary artery bypass grafting (on pump or off pump)

4. Willing and able to provide written informed consent and comply with study requirements and accepting the need of conversion if needed.

5. Patient is willing to comply with all follow-up visits

Exclusion Criteria:

1. Severe congestive heart failure (class III or IV according to NYHA, or pulmonary edema, cardiogenic shock) at the time of enrollment.

2. Prior surgery with the opening of pericardium or pleura.

3. Prior stroke (within 6 months)or more than 6 months if there are substantial neurological defects.

4. Acute ST-elevation MI within 72 hours prior to enrollment requiring revascularization.

5. Planned simultaneous surgical procedure unrelated to coronary revascularization (e.g. valve repair/replacement, aneurysmectomy, carotid endarterectomy or carotid stenting).

6. Contraindication to either CABG, MIDCAB or PCI/DES because of a coexisting clinical condition.

7. Significant leukopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis.

8. Intolerance or contraindication to aspirin or both clopidogrel and ticlopidine

9. Extra-cardiac illness that is expected to limit survival to less than 5 years e.g. oxygen-dependent chronic obstructive pulmonary disease, active hepatitis or significant hepatic failure, severe renal disease.

10. Suspected pregnancy. A pregnancy test will be administered prerandomization to all women of child-bearing age.

11. Patient inaccessible for follow-up visits required by protocol.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Procedure:
• minimal invasive coronary artery bypass graft surgery
coronary artery bypass grafting surgery by using a minimal invasive technique

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mohammed Farouk Abdel Hafez

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measuring rate of intraoperative complications occurrence	measuring the rate of complications as bleeding , failure of complete revascularization and cardiac arrest during operation	2 years
Primary	measuring rate of intraoperative conversion to open sternotomy		2 years
Primary	measuring amount of post operative bleeding	measuring the amount of bleeding in the drains in 48 hours post operative in cc	2 years
Primary	measuring post operative pain	measuring pain using wong-baker faces pain rating scale	2 years
Primary	measuring rate of reexploration	measuring the need of reexploration of the patient due to post operative massive bleeding	2 years
Primary	measuring rate of wound infection		2 years
Primary	calculating days of postoperative hospital stay		2 years
Primary	calculating time to regain normal activity		2 years