Minimally Invasive Coronary Artery Bypass Surgery in Patients With Multi Vessel Coronary Disease

This is a pilot study that wants to evaluate the feasibility of performing complete CABG through minimamlly invasive access, in patients with multi vessel disease (2 or more diseased coronaries), without compromising safety measured by major adverse events (death, myocardial infarction, stroke, or unplanned revascularization)

Conversion rate

• Off Pump to On Pump surgery (regardless of mini thoracotomy or conventional sternotomy)
• mini thoracotomy to conventional sternotomy

Surgical team will define preoperatively the number of coronaries to be grafted. After the surgical procedure is completed, the number of performed grafts will be compared to the initial plan. Incomplete revascularization will be considered if the number of grafts performed is lower than the predicted. This is important to measure feasibility

Postoperative bleeding volume will be measured in the first 48 hours after surgery. It will also be correlated to pre and postoperative hematocrit values. Blood flow transfusions during surgery and 24 hours after surgery will be measured.

Surgery duration (hours) will be timed from the skin incision until skin dressing is finished.

Orotracheal intubation will be measured in hours from the oral intubation to extubation

Length of ICU and hospital stay (days) will be timed from patient's entry on the sector until medical discharge is determined by intensive care and/or cardiology teams.

Intra operative time flow measurement (TTFM) allows measuring the graft flow using the MedStim devices.

Three variables are analyzed: Graft flow, pulsatility index and diastolic flow percentage.

Normal flow measures are expected to be over 15ml/min, pulsatility index is expected to be lower than 5 and diastolic flow percentage is expected to be over 50%.

This is an important and specific assessment carried out exclusively during the surgical procedure.

If the values found in the data differ from the data considered normal (shown above), reevaluation of the graft through exploration of the anastomosis should be considered.

This values will be compared in the group of patients operated through regular sternotomy and those operated through left mini thoracotomy. If statistical differences are found it could suggest that the quality of the anastomosis colud differ between techniques

Periprocedural myocardial infarction (type 5 MI) will be defined according to the Fourth Universal Definition of Myocardial Infarction (UDMI-4, 2018) as an elevation of cardiac troponin values greater than 10 times the upper reference limit (URL) in patients with normal baseline levels, accompanied by at least one of the following objective indicators of myocardial ischemia: New pathological Q waves on electrocardiogram; new left bundle branch block; new regional motion abnormalities on echocardiography; angiography evidence of new occlusion of a native coronary artery or bypass graft.

To enhance methodological rigor and allow comparison with contemporary clinical trials, the periprocedural MI definition proposed by the Academic Research Consortium-2 (ARC-2) will also be adopted as a secondary criterion, which includes: Troponin elevation >70× URL, or CK-MB elevation >10× URL, in association with hemodynamic instability, need for circulatory support.

Operative mortality and is defined as:

• all deaths, regardless of cause, occurring within 30 days from the procedure (including patients transferred to other care facilities);
• all deaths, regardless of cause, occurring after discharge from the hospital, but before the end of the 30th postoperative day (except for traumatic / external causes)

Wound infection will be defined by the presence of phlogistic signs at the incision, associated to the presence of purulent secretion and laboratorial exams.

Postoperative atrial fibrillation (AF) will be defined as any new-onset episode requiring medical treatment, excluding patients with a prior or chronic history atrial fibrillation. Time Frame: AF assessment will be assessed at three time points:

• Immediate postoperative: from the day of surgery to postoperative day 7.
• Early late postoperative: from postoperative day 8 to day 30.
• Late outpatient assessment: between 30 days and 6 months post-surgery.

Procedure related stroke will be defined as a new neurological deficit lasting more than 72 hours, confirmed by neurological examination and brain imaging (computed tomography and/or magnetic resonance), with interpretation by a neurologist. Stroke assessment will be performed at threetime points:

• Immediate postoperative: from the day of surgery to postoperative day 7.
• Early late postoperative: from postoperative day 8 to day 30.
• Late outpatient assessment: between 30 days and 6 months post-surgery.

Postoperative quality of life will be assessed using the EuroQol EQ-5D-5L questionnaire, administered by telephone within 6 months after surgery.

Left anterior minithoracotomy surgery will be considered safe if the patient's postoperative recovery occurs with similar incidence of of major cardiac or cerebral events, as compared to the classical sternotomy (considered the gold standard procedure).

Safety will be measured by major cariovascular and cerebral events, that include:

• Cause of death (cardiac vs. non-cardiac);
• Myocardial infarction type
• stroke type and severity.

All this variables mentioned are described with details on its respectives outcomes measures