IMPACT-MIDCAB

Study overview

Evaluates a novel treatment strategy combining temporary mechanical circulatory support (Impella) with robotically assisted minimally invasive coronary artery bypass (RA-MIDCAB) surgery in high-risk patients with severe coronary artery disease (CAD) and impaired heart function.

The study will assess procedural safety, short-termcardiac and neurological outcomes, improvements in cardiac performance, recovery trajectories, and cost-effectiveness compared with conventional coronary artery bypass surgery (CABG).

Objectives

General

Develop and evaluate innovative treatment approaches for patients with advanced cardiovascular disease who have limited therapeutic options remaining. Work Package 4 (WP4) focuses on providing a potential “late-stage treatment pathway” by restoring heart function, promoting recovery, or improving quality of life in patients with end-stage heart failure or complex coronary artery disease. To achieve this, WP4 integrates regenerative therapies, mechanical circulatory support, minimally invasive surgical techniques, and ex vivo heart perfusion technologies. The overall aim is to improve survival, enhance functional recovery, and reduce dependence on long-term mechanical support or heart transplantation in patients with otherwise poor clinical prospects.

Primary

Assess the logistical and technical feasibility of performing robotically assisted minimally invasive direct coronary artery bypass (RA-MIDCAB) surgery with temporary Impella support in patients with severe left ventricular dysfunction (left ventricular ejection fraction ≤30%).

Secondary

• Determine the rate of major adverse cardiac and cerebrovascular events (MACCE) within 30 days after the procedure.
• Evaluate changes in left ventricular ejection fraction (LVEF) at 90 days following surgery.
• Assess all-cause mortality and cardiovascular mortality during the first 12 months after treatment.

Study design: Prospective, multicenter, single-arm feasibility study

This multicenter feasibility study follows patients with severely reduced heart function who undergo robotically assisted minimally invasive coronary bypass surgery supported by the Impella heart pump. The study evaluates the safety, practicality, and early outcomes of this treatment approach across multiple specialized centers.