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

Not Applicable

• Conditions: Coronary Arterial Disease (CAD); Coronary Artery Bypass

• Registration Number: NCT06794359
• Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary

The objective of this study is to evaluate the safety and feasibility of Minimally Invasive Coronary Artery Bypass surgery in selected patients ,with multi vessel coronary disease.

This trial is designed to be a pilot study that will gather comparative information on the clinical performance of the minimally invasive treatment, evaluated by the composite measure of all-cause death, myocardial infarction, stroke, or unplanned repeat revascularization - in hospital, 30-day and 6 months.

Detailed Description

Minimally invasive surgery has been a breakthrough in medicine, especially in more developed countries. It represents an evolution of current techniques associated with new technologic devices, that allow a safe and effective procedure associated to an aesthetic benefit.

Invasive treatment of coronary artery disease has been on a plateau lately. Percutaneous treatment that emerged as a promise to replace surgical methods, has already shown its limitations, even with the use of drug-eluting stents. Traditional CABG (coronary artery bypass grafting surgery), which has been considered the gold standard, has been criticized for its high degree of invasiveness.

Based on this precept, interest has emerged in creating a surgical approach that causes less trauma. Surgical access using minimally invasive incisions are gaining space and have shown less postoperative pain, shorter hospital stays, earlier mobilization and functional recovery, in addition to reducing the costs of the procedure.

Cardiac surgery has some challenges that are beyond other specialties. The heart is a vital organ with intrinsic chronotropism that lies inside a rigid rib cage.

Specifically, in coronary artery bypass graft surgery (CABG), the thin caliber of the coronaries and their distribution throughout the cardiac territories creates even a greater challenge. However, new surgical techniques associated with new devices, demonstrated the viability of complete revascularization through a limited access incision.

In an attempt to minimize surgical trauma and the morbidities caused by conventional median sternotomy and the use of On Pump surgery, some alternatives have emerged with promising results.

Among those efforts, we can highlight the beginning of the coronary artery grafting surgery without the use of cardiopulmonary bypass (Off Pump CABG), followed by hybrid revascularization, minimally invasive surgery by lateral thoracotomy under direct vision, partially assisted robot surgery and fully endoscopic surgery with using robots.

Currently, minimally invasive surgery though mini lateral thoracotomy is the most common technique used. Initially it was used only for the treatment of the left anterior descending artery (LAD), but technology advances and surgical improvement allowed complete revascularization under direct vision. Surgery can be performed with or without the aid of cardiopulmonary bypass (CPB), treatment individualization is necessecary for every case.

This is a pilot study to evaluate the safety and feasibility of Minimally Invasive Coronary Artery Bypass surgery in selected patients ,with multi vessel coronary disease.

Study Timeline

• Study Start: 2023-10-01
• Study First Submitted: 2024-10-14
• Status Verified: 2024-12
• Study First Submitted QC: 2025-01-20
• Last Update Submitted: 2025-01-20
• Study First Posted: 2025-01-27
• Last Update Posted: 2025-01-27
• Primary Completion: 2026-07-01
• Study Completion: 2026-12-01

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients 18-years-old or older

• Isolated myocardial revascularization procedure

• Double or Triple-vessel disease with proximal or mid LAD disease with angiographic diameter stenosis > 70% by visual analysis in all territories, requiring myocardial revascularization OR proximal LAD disease with angiographic diameter stenosis 50-70% by visual analysis in any territory but with invasive or non-invasive evidence of flow-limiting stenosis in all three territories, requiring myocardial revascularization

• Total SYNTAX score > 22 or low Syntax score unsuitable for PCI

• Clinical and anatomic eligibility for both Minimally invasive and Conventional CABG surgery as agreed to by surgical team.

• Silent ischemia, stable angina, unstable angina or recent MI

  • If recent MI, cardiac biomarkers must have returned to normal prior to randomization

• Ability to sign informed consent and comply with all study procedures

Exclusion Criteria

• Reoperation
• Need for any concomitant cardiac surgery other than CABG (e.g. valve surgery, aortic repair, etc.), or intent that if the patient randomizes to surgery, any cardiac surgical procedure other than isolated CABG will be performed
• Left ventricle disfunction (EF<40%)
• Chronic Pulmonary obstructive disease
• Renal failure disease
• Emergency surgery
• Obesity
• Sternum anatomic defects including pectus excavatum
• Peripheral vascular disease
• Ascending aorta severe calcification
• Non cardiac co-morbidities with life expectancy less than 1 year

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Feasibility and safety of proposed revascularization through minimally invasive approach	Clinical follow-up intra hospitalar, 30-day and 6 months	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)

Secondary Outcome Measures

Name	Time	Method
Surgery duration	Intraoperative measure	Surgery duration (hours) will be timed from the skin incision until skin dressing is finished.
Intraoperative conversion rate	Intraoperative measure	Conversion rate; * Off Pump to On Pump surgery (regardless of mini thoracotomy or conventional sternotomy); * mini thoracotomy to conventional sternotomy
Postoperative bleeding volume	First 48 hours after surgery	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.
Complete revascularization rate	Intraoperative measure	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
Length of orotracheal intubation	From oral intubation until extubation	Orotracheal intubation will be measured in hours from the oral intubation to extubation
Length of ICU and hospital stay	From date of ICU admissiton until the date of discharge	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 graft evaluation	This is a specific assessment carried out during the surgical procedure (intraoperative).	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
Postoperative myocardial infarction	Within 48 Hours from surgery	Postoperative myocardial infarction will by evaluated following Academic Research Consortium-2 Consensus Document (ARC-2); ARC-2 Absolute rise in cardiac troponin (from baseline) ≥35 times upper reference limit within 48 Hours from surgery; Plus 1 (or more) of the following criteria: * New significant\* Q waves or equivalent; * Flow-limiting angiographic complications; * New "substantial" loss of myocardium on imaging; Significant periprocedural myocardial injury: - Absolute rise in cardiac troponin (from baseline) ≥70 times upper reference limit
Surgical Mortality	30 days after surgery	Operative mortality and is defined as: 1. all deaths, regardless of cause, occurring within 30 days from the procedure (including patients transferred to other care facilities); 2. 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	From surgery to 30 days after surgery	Wound infection will be defined by the presence of phlogistic signs at the incision, associated to the presence of purulent secretion and laboratorial exams.
Post operatative atrial fibrillation	AF related to surgery will be acessed in phases: - Early postoperative: From the day of surgery until 7 days after it. - Late postoperative: 7 days after surgery until 30 days after surgery AF will be also evaluated on Outpatient Midterm follow	Post operatative atrial fibrillation is considered if the patient presented any episode requiring treatment, excluding patients with chronic or previous history atrial fibrillation
Neurological events	Stroke related to surgery will be acessed in phases: - Early postoperative: From the day of surgery until 7 days after it. - Late postoperative: 7 days after surgery until 30 days after surgery Stroke will be also evaluated on Outpatient Midterm follow	Stroke related to surgical procedure will be defined as a new neurological deficit that lasts for more than 72 hours and occurs after surgery.; Stroke diagnosis will be determined by a neurologist by physical examination associated with imaging tests (ultrasound with doppler perfusion and/or CT or NMR when needed).; Stroke related to surgery will be acessed in phases: * Early postoperative: From the day of surgery until 7 days after it.; * Late postoperative: 7 days after surgery until 30 days after surgery; Stroke will be also evaluated on Outpatient Midterm follow up: * Outpatient medical appointment 30 days after hospital discharge; * Last evaluation will happen after 6 months from surgery by phone call
Quality of life	Up to 180 days after hospital dischart	Post operative quality of life will be measured using Euroqol EQ-5D-5L questionnaire. It will be carried out at 1 and 6 months after surgery, through telephone contact.
Safety	30-day and 6 months after discharge from hospital	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

Trial Locations

Locations (1)

INCOR - Heart Institute from the University of Sao Paulo; 🇧🇷 Sao Paulo, SP, Brazil