MiECC Versus Conventional Cardiopulmonary Bypass in Cardiac Surgery (MiECS)
The MiECS study is looking into whether a newer, smaller heart-lung machine, called 'minimally invasive extracorporeal circulation' (MiECC), is better than the traditional 'conventional cardiopulmonary bypass' (cCPB) machine during heart surgery. When you have heart surgery, your heart is stopped, and a machine takes over the work of your heart and lungs. While life-saving, this can sometimes lead to complications. This large international study wants to find out if the newer, smaller machine can reduce serious issues after surgery, such as heart attack, stroke, or kidney problems, and potentially help patients recover faster. It's a big step to improve how heart surgery is done worldwide.
At a glance
What is this study about?
When you have open-heart surgery for conditions like blocked heart arteries (coronary artery disease) or a faulty heart valve (aortic valve stenosis), your heart needs to be stopped so the surgeons can operate. During this time, a special machine, often called a 'heart-lung machine' or 'conventional cardiopulmonary bypass' (cCPB), takes over the job of pumping blood and oxygen around your body. Although this machine is vital for surgery, it can sometimes lead to serious problems afterwards, like heart attack, stroke, kidney issues, or needing extra time in hospital.
Over the years, doctors have tried different ways to lower the risk of these complications. One newer approach is to use a smaller, 'miniaturised' heart-lung machine, known as 'minimally invasive extracorporeal circulation' (MiECC). The idea is that these smaller machines might be gentler on the body and cause fewer side effects than the traditional ones. However, because there are many different types of these smaller machines, and previous studies haven't been strong enough, we don't yet know for sure if they truly reduce risks for patients. As a result, most hospitals still use the standard heart-lung machine.
This important study, called MiECS, is designed to give us clear answers. It's one of the largest studies of its kind, involving many hospitals around the world. The main goal is to see if using the newer, smaller MiECC system during heart surgery leads to fewer serious problems like heart attack, stroke, or kidney damage within 30 days of the operation, compared to the standard machine. The study also hopes to find out if using the smaller machine means patients need fewer blood transfusions, can leave intensive care and the hospital sooner, and generally use fewer hospital resources during their recovery. The findings from this study could change how heart surgery is performed globally, helping to make it safer for many patients.
Key takeaways
- Compares two types of heart-lung machines in heart surgery.
- Aims to see if the newer, smaller machine (MiECC) reduces complications.
- Focuses on common heart conditions like blocked arteries or faulty valves.
- Participation involves routine surgery and follow-up data collection.
- Could improve safety and recovery for future heart surgery patients.
Who may be eligible?
This study is looking for adults aged 18 to 85 years old who are having certain types of heart surgery. This includes operations to bypass blocked heart arteries (coronary artery bypass grafting), replace a faulty aortic valve, or both. You must be having these operations planned as either routine or urgent surgery, and a heart-lung machine will be used, but not for fully stopping your blood circulation (circulatory arrest).
However, you won't be able to join if your surgery is a true emergency, or if you need more complex surgery on your aorta (the main artery from your heart). Also, if you have religious or personal reasons for not wanting a blood transfusion, or if you have certain existing blood disorders that affect clotting or red blood cells (though having anaemia from low iron is generally okay), then you unfortunately can't take part. Lastly, you need to be able to understand the study information and give your consent to participate.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you between 18 and 85 years old?
- Are you having surgery for blocked heart arteries, a faulty aortic valve, or both?
- Is your surgery planned (elective) or urgent, rather than a true emergency?
- Are you okay with having a blood transfusion if needed (not for religious or specific medical reasons)?
- Can you understand the study information and agree to take part?
What does participation involve?
If you decide to take part in this study, you will be randomly assigned to receive either the standard heart-lung machine or the newer, smaller one during your heart surgery. This is like flipping a coin, so neither you nor your doctors can choose which machine you get. After your surgery, the study team will closely monitor your recovery. This involves tracking any potential complications like heart attack, stroke, or kidney problems for up to 30 days. They will also record how long you stay in intensive care and the hospital, and whether you need blood transfusions. There are no additional visits or medications required beyond your usual hospital care for your surgery and recovery. The study team will simply gather information from your medical records during your hospital stay and for a short period after surgery.
Potential risks and benefits
Locations (13)
- Perfusion Services University Health Network, Toronto General HospitalVerified postcodeToronto, Canada· Recruiting
- Department of Cardiac SurgeryVerified postcodeCoswig, Germany· Active not recruiting
- Department of Thoracic and Cardiovascular Surgery, University Medical Centre GoettingenVerified postcodeGöttingen, Germany· Active not recruiting
- Department of Cardiothoracic and Vascular Surgery, Ulm University HospitalVerified postcodeUlm, Germany· Completed
- Cardiothoracic Department AHEPA University HospitalVerified postcodeThessaloniki, Greece· Recruiting
- Department of Cardiac Surgery GVM Anthea HospitalVerified postcodeBari, Italy· Recruiting
- Department of Cardiac Surgery GVM Maria Eleonora HospitalVerified postcodePalermo, Italy· Active not recruiting
- Department of Cardiovascular Surgery, Ankara City HospitalVerified postcodeAnkara, Turkey (Türkiye)· Active not recruiting
- Department of Cardiovascular Surgery, Izmir Bakırçay University, Faculty of MedicineVerified postcodeIzmir, Turkey (Türkiye)· Recruiting
- Department of Cardiovascular Surgery, Faculty of Medicine, Recep Tayyip Erdoğan UniversityVerified postcodeRize, Turkey (Türkiye)· Recruiting
- Department of Cardiac Surgery, Royal Papworth HospitalVerified postcodeCambridge, United Kingdom· Active not recruiting
- Deparment of Cardiac Surgery, Castle Hill HospitalVerified postcodeHull, United Kingdom· Active not recruiting
Common questions
What is a heart-lung machine?
It's a machine that takes over the work of your heart and lungs during heart surgery when your heart needs to be stopped.
What is the difference between the two machines being studied?
One is the standard heart-lung machine, and the other is a newer, smaller version that doctors hope might reduce side effects.
Will I know which machine I'll get?
No, you will be randomly assigned to one machine, like rolling a dice. Neither you nor your doctor can choose.
How long does the study last?
The study focuses on your recovery typically for up to 30 days after your heart surgery.
Who is running this study?
This is a large international study led by researchers in Greece, with many hospitals worldwide taking part.
How to find out more
Georgios Papazisis, Assoc. Prof.
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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