Safety and Effectiveness of No-touch Technique for Ascending Aorta in MICS-CABG

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorPeking University Third Hospital

About this trial

The goal of this single-center prospective cohort study is to compare perioperative safety metrics and follow-up survival analyses in patients receiving Minimally Invasive Cardiac Surgery Coronary Artery Bypass Grafting(MICS-CABG) and Off-Pump Coronary Artery Bypass(OPCAB). The main question it aims to answer is:

Is the bridge vessel patency rate of patients in the MICS-Notouch group noninferior to that of a saphenous vein bridge with conventional open-chest bypass?

Participants will be divided into two groups:

Exposure group (MICS-Notouch group): non-extracorporeal circulation multiple coronary artery bypass grafting surgery performed under direct visualization of a small incision in the left chest, including the application of LIMA (left internal mammary artery) + SVG (saphenous vein) multiple bypass grafting.

Control group (OPCAB group): conventional median chest opening, non-extracorporeal circulation multi-branch coronary artery bypass graft surgery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients with angina pectoris who experience functional limitations in daily life and work despite conservative medical treatment and who require coronary artery bypass grafting surgery, as confirmed by coronary angiography, are eligible for enrollment.

Patients with calcification of the ascending aorta, as confirmed by CT, who are not suitable for sidewall clamping are also eligible for enrollment.

Disqualifiers

The patient presents with an old, large myocardial infarction with no surviving myocardium, as evidenced by both isotope and echocardiographic imaging. This is a group of patients who are prone to complications, including significant cardiac enlargement, a cardiothoracic ratio greater than 0.75, an ejection fraction (EF) less than 30%, a left ventricular diameter (LVDd) greater than 70mm, the presence of a left ventricular ventricular wall tumor, or severe arrhythmia. Intraoperative hemodynamic instability;

Valve surgery or other intracardiac surgery at the same time;

Patients expected to undergo extracorporeal circulation surgery;

Poor myocardial infarction conditions, extensive lesions, distal or full diffuse stenosis, or lumen diameter less than or severe calcification that cannot be anastomosed.

Trial population

Patients to undergo coronary artery bypass grafting due to coronary heart disease.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • Non-extracorporeal multiple coronary artery bypass graft (CABG) performed under direct visualization through a small incision in the left side of the chest.

    Procedure/Surgery

    Exposure group (MICS-Notouch group): Direct visualization non-extracorporeal coronary artery bypass grafting with a small left chest incision, including the use of LIMA (left internal mammary artery) + SVG (saphenous vein) multibranch bypass grafting.

  • Multi-branch coronary artery bypass grafting with conventional median open heart and off-pump circulation

    Procedure/Surgery

    Control Group (OPCAB Group): Conventional median open multiple coronary artery bypass grafting with extracorporeal circulation.

Treatment groups

260 Participants
are divided into 2 treatment groups
Group A: Exposure group (MICS-Notouch group)1 intervention
Group B: Control group (OPCAB group)1 intervention

Trial outcomes

Primary outcomes

1

Early Postoperative Saphenous Vein Bridge Vessel Patency Rate

The patients' bridge vessel patency is assessed by angiography within 1-14 days after surgery.

Time frame
1-14 days after surgery
2

Early Postoperative Saphenous Vein Bridge Vessel Patency Rate

The patients' bridge vessel patency is assessed by Coronary Computed Tomography Angiography within 1-14 days after surgery.

Time frame
1-14 days after surgery

Secondary outcomes

1

Perioperative Safety Indicators

The following variables were considered: transfusion volume, extracorporeal circulation transfer rate, IABP and ECMO utilization rate, reoperation rate, incidence of poor wound healing, 1-year postoperative bridging vessel patency rate (CT or angiography), incidence of perioperative MACCE, incidence of atrial fibrillation, incidence of renal failure, incidence of re-tracheal intubation, duration of postoperative hospitalization, duration of ICU stay, duration of mechanical ventilation, and hospitalization costs.

Time frame
One year after surgery
2

Survival Analysis

The occurrence of MACCE (including all-cause mortality, re-bypass or stenting, acute infarction, and stroke), as well as readmission for infarction or heart failure at 1, 3, 6, and 12 months postoperatively, will be monitored.

Time frame
One year after surgery

Other outcomes

Sponsors and contacts

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