MiECC vs Conventional Bypass for Heart Surgery

(MiECS Trial)

Recruiting at 15 trial locations

Overseen By Georgios Papazisis, Assoc. Prof.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Aristotle University Of Thessaloniki

Disqualifiers: Emergency surgery, Major aortic surgery, Blood transfusion objection, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

1300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to support the heart during surgery using Minimal Invasive Extracorporeal Circulation (MiECC). Researchers aim to determine if MiECC can reduce complications after heart surgeries, such as bypass grafting or valve replacement, compared to conventional cardiopulmonary bypass (cCPB). The trial seeks participants scheduled for non-emergency heart surgeries involving these procedures. Participants must not require major aortic surgery or have issues with blood transfusions. As an unphased trial, this study provides a unique opportunity to contribute to innovative heart surgery techniques that could enhance future patient outcomes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these bypass methods are safe for heart surgery?

Research has shown that Minimal Invasive Extracorporeal Circulation (MiECC) is generally safe for heart surgeries. A review combining results from various studies found that MiECC reduces complications after surgery. The largest heart surgery database, containing information from over 200,000 procedures, reports excellent results with this method.

However, while MiECC offers many benefits, some risks remain. Some studies mention that about 30% of high-risk patients experience serious problems after surgery. These rates are not unusual given the complexity of heart surgeries.

In summary, MiECC is considered safe and effective for heart surgeries, though it carries some risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Minimal Invasive Extracorporeal Circulation (MiECC) is unique because it offers a less invasive approach to heart surgery compared to the conventional cardiopulmonary bypass (cCPB). The key advantage of MiECC is that it reduces the contact between blood and foreign surfaces, which may lower the risk of inflammation and related complications during surgery. Researchers are excited about this technique because it has the potential to improve patient outcomes by minimizing surgical trauma and promoting faster recovery.

What evidence suggests that this trial's treatments could be effective for heart surgery?

This trial will compare Minimal Invasive Extracorporeal Circulation (MiECC) with Conventional Cardiopulmonary Bypass (cCPB) for heart surgery. Research has shown that MiECC holds promise in reducing complications after heart surgery. Studies indicate that MiECC can lower the risk of serious problems like stroke, kidney failure, and heart attacks compared to traditional methods. A review of multiple studies confirms that MiECC results in fewer health issues and deaths after surgery. Patients tend to recover better with fewer side effects. Overall, MiECC makes heart surgery safer and more natural, as it more closely mimics the body's functions than conventional methods. ^{1 2 3 6 7}

Who Is on the Research Team?

Kyriakos Anastasiadis, Professor

Principal Investigator

Aristotle University Of Thessaloniki

Polychronis Antonitsis, Assoc. Prof.

Principal Investigator

Aristotle University Of Thessaloniki

Are You a Good Fit for This Trial?

This trial is for patients needing elective or urgent heart surgery for coronary artery disease or aortic valve issues, using a heart-lung machine but not requiring complex aortic surgery. Participants must be able to consent and can't have blood disorders or objections to blood transfusions.

Inclusion Criteria

I am scheduled for heart surgery involving bypass or valve replacement without stopping my circulation.

Exclusion Criteria

Inability to give informed consent for the study (e.g. learning or language difficulties)

You cannot or do not want to receive blood transfusions, for example, if you are a Jehovah's Witness.

I need major surgery on my aorta.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo cardiac surgery using either MiECC or cCPB systems

1 week

In-hospital stay for surgery and initial recovery

Follow-up

Participants are monitored for postoperative complications and recovery

30 days

Regular follow-up visits and monitoring

Extended Follow-up

Participants' health-related quality of life is assessed

90 days

What Are the Treatments Tested in This Trial?

Interventions

• Conventional cardiopulmonary bypass
• Minimal Invasive Extracorporeal Circulation

Trial Overview The study compares two types of heart-lung machine techniques: the standard method (conventional cardiopulmonary bypass) and a newer, less invasive system (MiECC). The goal is to see if MiECC reduces serious complications after surgery.

How Is the Trial Designed?

Group I: Minimal Invasive Extracorporeal Circulation (MiECC) Active Control 1 Intervention

Patients undergoing coronary artery bypass grafting (CABG), aortic valve replacement (AVR), or combined procedure (AVR+CABG) with Minimal Invasive Extracorporeal Circulation (MiECC).

Group II: Conventional Cardiopulmonary Bypass (cCPB) Active Control 1 Intervention

Patients undergoing coronary artery bypass grafting (CABG), aortic valve replacement (AVR), or combined procedure (AVR+CABG) with conventional cardiopulmonary bypass (cCPB)

Conventional cardiopulmonary bypass is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as cCPB for:

• Cardiac surgery
• Coronary artery bypass grafting (CABG)
• Heart transplantation
• Valve repair and replacement

Approved in United States as cCPB for:

• Cardiac surgery
• Coronary artery bypass grafting (CABG)
• Heart transplantation
• Valve repair and replacement

Approved in Canada as cCPB for:

• Cardiac surgery
• Coronary artery bypass grafting (CABG)
• Heart transplantation
• Valve repair and replacement

Approved in Japan as cCPB for:

• Cardiac surgery
• Coronary artery bypass grafting (CABG)
• Heart transplantation
• Valve repair and replacement

Approved in China as cCPB for:

• Cardiac surgery
• Coronary artery bypass grafting (CABG)
• Heart transplantation
• Valve repair and replacement

Approved in Switzerland as cCPB for:

• Cardiac surgery
• Coronary artery bypass grafting (CABG)
• Heart transplantation
• Valve repair and replacement

Who Is Running the Clinical Trial?

Aristotle University Of Thessaloniki

Lead Sponsor

Trials

283

Recruited

79,800+

Minimal Invasive Extracorporeal Technologies International Society (MiECTiS)

Collaborator

Trials

1

Recruited

1,300+

Clinical Research Unit, School of Medicine, Aristotle University of Thessaloniki

Collaborator

Trials

1

Recruited

1,300+

Published Research Related to This Trial

The minimal extracorporeal circuit (MECC) system used in coronary artery bypass grafting (CABG) resulted in significantly lower transfusion requirements and reduced myocardial damage, as indicated by lower levels of cTnI compared to the conventional cardiopulmonary bypass (CPB) system.

Patients using the MECC system showed quicker recovery of activated partial thromboplastin time (aPTT) to normal levels and lower concentrations of free hemoglobin, suggesting it may be a safer option for patients undergoing extracorporeal circulation during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beneficial effects of using a minimal extracorporeal circulation system during coronary artery bypass grafting. Liu, Y., Tao, L., Wang, X., et al.[2014]

Oncoplastic breast-conserving surgery (OPBCS) is generally superior to conventional breast-conserving surgery (CBCS) in terms of surgical outcomes, although CBCS showed lower rates of re-excision (49% less likely) which is a significant advantage.

Both surgical techniques had similar safety profiles, with no significant differences in local recurrence rates, close surgical margins, or the risk of mastectomy, suggesting that OPBCS can be recommended without compromising safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Oncoplastic versus conventional breast-conserving surgery in breast cancer: a pooled analysis of 6941 female patients. Hasan, MT., Hamouda, M., Khashab, MKE., et al.[2023]

Hybrid endoscopy-assisted breast-conserving surgery (EBCS) demonstrated effective surgical outcomes with a low rate of positive margins (1.4%) and no local recurrences observed in patients over an average follow-up of 18 months.

Patients who underwent hybrid EBCS experienced better cosmetic results compared to those who had conventional breast-conserving surgery (CBCS), particularly with less noticeable scarring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technical feasibility and cosmetic advantage of hybrid endoscopy-assisted breast-conserving surgery for breast cancer patients. Ozaki, S., Ohara, M., Shigematsu, H., et al.[2013]

Closed circuit extracorporeal circulation (CCECC) significantly reduces red blood cell damage and coagulation activation compared to conventional cardiopulmonary bypass (CPB) during coronary artery bypass grafting (CABG), as shown in a study of 30 patients.

While CCECC showed similar benefits to off-pump coronary artery bypass grafting (OPCAB), it also resulted in increased fibrinolysis and inflammatory markers postoperatively, indicating a need for further research to understand these effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of minimally invasive closed circuit extracorporeal circulation with conventional cardiopulmonary bypass and with off-pump technique in CABG patients: selected parameters of coagulation and inflammatory system. Wippermann, J., Albes, JM., Hartrumpf, M., et al.[2006]

Miniaturised cardiopulmonary bypass (Mini-CPB) may lead to a lower risk of postoperative stroke (0.2% vs 2.0%) and somewhat reduced mortality (1.1% vs 2.2%) compared to conventional cardiopulmonary bypass (C-CPB), based on a meta-analysis of 13 studies involving 1161 patients.

Mini-CPB is associated with significantly less postoperative blood loss and a higher platelet count 6 hours after surgery, suggesting improved recovery outcomes, although further large-scale studies are needed for more definitive conclusions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Meta-analysis of randomised trials comparing the effectiveness of miniaturised versus conventional cardiopulmonary bypass in adult cardiac surgery. Biancari, F., Rimpiläinen, R.[2009]

In a study of 220 breast cancer patients, oncoplastic breast-conserving surgery (OP-BCS) was found to have similar costs to mastectomy with immediate two-stage implant-based reconstruction (M-IBR), while being less expensive than conventional breast-conserving surgery (C-BCS).

Complication rates were significantly lower for C-BCS (5.5%) compared to OP-BCS (17%) and M-IBR (34%), suggesting that OP-BCS may offer a balance of effective treatment with better cosmetic outcomes and fewer complications than M-IBR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing costs of standard Breast-Conserving Surgery to Oncoplastic Breast-Conserving Surgery and Mastectomy with Immediate two-stage Implant-Based Breast Reconstruction. Witmer, TJK., Kouwenberg, CAE., Bargon, CA., et al.[2022]

In a study of 401 participants who underwent either off-pump coronary bypass grafting (OPCAB) or conventional bypass grafting (CABG-CPB), quality of life (QoL) scores were similar for both groups two to four years post-surgery, indicating comparable long-term outcomes.

Despite the similar QoL scores, both groups reported poorer than normal physical health, although mental health scores were within normal ranges, suggesting that while surgical methods may not differ in long-term QoL, patients may still experience ongoing physical health challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beating heart against cardioplegic arrest studies (BHACAS 1 and 2): quality of life at mid-term follow-up in two randomised controlled trials. Ascione, R., Reeves, BC., Taylor, FC., et al.[2015]

A study of 412 patients with early breast cancer found that oncoplastic breast surgery (OBS), non-oncoplastic breast conserving surgery (NBCS), and mastectomy all resulted in similar rates of postoperative complications, local recurrences, and disease-free survival, indicating that all three surgical options are viable.

OBS had a lower re-excision rate (6.5%) compared to NBCS (8%), suggesting that OBS may be slightly more effective in achieving clear margins during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Oncoplastic Breast Surgery, Non-oncoplastic Breast Conserving Surgery and Mastectomy in Early Breast Cancer: A Single Center Retrospective Study. Sagiroglu, J., Ozemir, IA., Eren, T., et al.[2021]

In a study of 466 patients undergoing coronary artery bypass surgery, miniaturized cardiopulmonary bypass (Mini-CPB) showed similar immediate postoperative outcomes to conventional cardiopulmonary bypass (C-CPB), with matched pairs demonstrating equal 30-day mortality rates of 1.3%.

Although in-hospital mortality was lower in the C-CPB group (1.4% vs. 3.0%), the Mini-CPB's efficacy may be more pronounced in high-risk patients or complex surgeries, suggesting it could be a valuable option in those scenarios.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome after coronary artery bypass surgery with miniaturized versus conventional cardiopulmonary bypass. Rimpiläinen, R., Biancari, F., Wistbacka, JO., et al.[2009]

Both off-pump coronary artery bypass (OPCAB) and miniaturized extracorporeal circulation (MECC) techniques significantly reduce 30-day all-cause mortality compared to conventional extracorporeal circulation (CECC), with MECC showing the greatest reduction.

OPCAB and MECC also lower the risk of postoperative complications such as cerebral stroke and renal dysfunction, making them safer alternatives to traditional CABG methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and efficacy of miniaturized extracorporeal circulation when compared with off-pump and conventional coronary artery bypass grafting: evidence synthesis from a comprehensive Bayesian-framework network meta-analysis of 134 randomized controlled trials involving 22 778 patients. Kowalewski, M., Pawliszak, W., Raffa, GM., et al.[2022]

The CorX system, a closed extracorporeal circuit used during coronary artery bypass grafting (CABG), resulted in significantly lower inflammatory markers (PMNE and TCC) compared to conventional cardiopulmonary bypass (CPB), indicating a reduced inflammatory response.

However, despite the reduced inflammation, patients using the CorX system experienced significantly higher intraoperative blood loss compared to those using standard CPB, suggesting that while the CorX system is safe, it may not provide clinical benefits in terms of bleeding management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Initial experience with a minimized extracorporeal bypass system: is there a clinical benefit? Abdel-Rahman, U., Ozaslan, F., Risteski, PS., et al.[2006]

In a study of 30 patients undergoing coronary artery bypass grafting, the miniaturized cardiopulmonary bypass (MCPB) system did not significantly reduce inflammation or coagulation disturbances compared to conventional cardiopulmonary bypass (CCPB), indicating similar clinical outcomes.

While no major complications occurred, the MCPB system presented safety concerns, such as air leaks and challenges in fluid management, suggesting that its use may require careful consideration despite its potential benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Miniaturized cardiopulmonary bypass in coronary artery bypass surgery: marginal impact on inflammation and coagulation but loss of safety margins. Nollert, G., Schwabenland, I., Maktav, D., et al.[2006]

In a study of 236 high-risk patients undergoing coronary artery bypass graft surgery, miniaturized cardiopulmonary bypass (Mini-CPB) was associated with a significantly lower stroke rate (0%) compared to conventional cardiopulmonary bypass (C-CPB) which had a stroke rate of 5.4%.

While in-hospital mortality rates were similar between the two groups, Mini-CPB showed a trend towards better outcomes, suggesting that it may provide enhanced cerebral protection during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Miniaturized versus conventional cardiopulmonary bypass in high-risk patients undergoing coronary artery bypass surgery. Koivisto, SP., Wistbacka, JO., Rimpiläinen, R., et al.[2010]

In a study of 1472 coronary artery bypass grafting (CABG) operations, minimal extracorporeal circulation (MECC) showed lower rates of arrhythmia (25%) and neurocognitive disorders (3%) compared to conventional cardiopulmonary bypass (CCPB) which had 35.6% and 7% respectively, suggesting MECC may be safer for patients.

MECC also resulted in significantly fewer blood transfusions (0.8 per patient) compared to CCPB (1.8 per patient), indicating that MECC not only reduces perioperative complications but also minimizes the need for blood products, making it a preferable option for CABG surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Minimal extracorporeal circulation and off-pump compared to conventional cardiopulmonary bypass in coronary surgery. Panday, GF., Fischer, S., Bauer, A., et al.[2009]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6586580/

Minimal invasive extracorporeal circulation (MiECC) MiECC significantly reduces this effect and renders on-pump cardiac surgery a “more physiologic” procedure (simulating off-pump surgery). CPB, cardiopulmonary ...

2. academic.oup.com academic.oup.com/ejcts/article/67/4/ezaf112/8093271

a contemporary systematic review and meta-analysis This meta-analysis provides robust evidence for the beneficial effect of MiECC in reducing postoperative morbidity and mortality after cardiac surgery.

3. sciencedirect.com sciencedirect.com/science/article/pii/S0914508714000288

The “benefits” of the mini-extracorporeal circulation in ... More than a third of the patients experience undesired effects due to coronary artery bypass grafting (CABG) [6]. CCPB can induce an inflammatory response and ...

4. jtcvsopen.org jtcvsopen.org/article/S2666-2736(21)00339-9/fulltext

A systematic review and meta-analysis MECC significantly reduces a composite of mortality, stroke, renal failure, and myocardial infarction compared with CECC after cardiac surgery.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05487612

MiECC Versus Conventional Cardiopulmonary Bypass in ... MiECS is one of the largest multicentre randomised controlled trials on extracorporeal circulation conducted under the auspices of Minimal Invasive ...

6. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003497516000552

Minimally Invasive Extracorporeal Bypass in ... Minimally invasive extracorporeal circulation (MECC) is predominantly used in coronary operations. Data supporting the benefits of MECC in minimally ...

7. jcvaonline.com jcvaonline.com/article/S1053-0770(24)00058-2/abstract

Is Minimally Invasive Extracorporeal Circulation Superior to ... Notwithstanding these positive trends, significant rates of operative mortality and major morbidity, reaching around 30%, persist not only in high-risk ...