Conventional versus minimally invasive extra-corporeal circulation in patients undergoing cardiac surgery: A randomized controlled trial (COMICS).

INTRODUCTION: The trial hypothesized that minimally invasive extra-corporeal circulation (MiECC) reduces the risk of serious adverse events (SAEs) after cardiac surgery operations requiring extra-corporeal circulation without circulatory arrest. METHODS: This is a multicentre, international randomized controlled trial across fourteen cardiac surgery centres including patients aged ≥18 and <85 years undergoing elective or urgent isolated coronary artery bypass grafting (CABG), isolated aortic valve replacement (AVR) surgery, or CABG + AVR surgery. Participants were randomized to MiECC or conventional extra-corporeal circulation (CECC), stratified by centre and operation. The primary outcome was a composite of 12 post-operative SAEs up to 30 days after surgery, the risk of which MiECC was hypothesized to reduce. Secondary outcomes comprised: other SAEs; all-cause mortality; transfusion of blood products; time to discharge from intensive care and hospital; health-related quality-of-life. Analyses were performed on a modified intention-to-treat basis. RESULTS: The trial terminated early due to the COVID-19 pandemic; 1071 participants (896 isolated CABG, 97 isolated AVR, 69 CABG + AVR) with median age 66 years and median EuroSCORE II 1.24 were randomized (535 to MiECC, 536 to CECC). Twenty-six participants withdrew after randomization, 22 before and four after intervention. Fifty of 517 (9.7%) randomized to MiECC and 69/522 (13.2%) randomized to CECC group experienced the primary outcome (risk ratio = 0.732, 95% confidence interval (95% CI) = 0.556 to 0.962, p = 0.025). The risk of any SAE not contributing to the primary outcome was similarly reduced (risk ratio = 0.791, 95% CI 0.530 to 1.179, p = 0.250). CONCLUSIONS: MiECC reduces the relative risk of primary outcome events by about 25%. The risk of other SAEs was similarly reduced. Because the trial terminated early without achieving the target sample size, these potential benefits of MiECC are uncertain.

2021 MiECTiS focused update on the 2016 position paper for the use of minimal invasive extracorporeal circulation in cardiac surgery.

The landmark 2016 Minimal Invasive Extracorporeal Technologies International Society (MiECTiS) position paper promoted the creation of a common language between cardiac surgeons, anesthesiologists and perfusionists which led to the development of a stable framework that paved the way for the advancement of minimal invasive perfusion and related technologies. The current expert consensus document offers an update in areas for which new evidence has emerged. In the light of published literature, modular minimal invasive extracorporeal circulation (MiECC) has been established as a safe and effective perfusion technique that increases biocompatibility and ultimately ensures perfusion safety in all adult cardiac surgical procedures, including re-operations, aortic arch and emergency surgery. Moreover, it was recognized that incorporation of MiECC strategies advances minimal invasive cardiac surgery (MICS) by combining reduced surgical trauma with minimal physiologic derangements. Minimal Invasive Extracorporeal Technologies International Society considers MiECC as a physiologically-based multidisciplinary strategy for performing cardiac surgery that is associated with significant evidence-based clinical benefit that has accrued over the years. Widespread adoption of this technology is thus strongly advocated to obtain additional healthcare benefit while advancing patient care.

Modular minimally invasive extracorporeal circulation ensures perfusion safety and technical feasibility in cardiac surgery; a systematic review of the literature.

INTRODUCTION: Despite extensive evidence that shows clinical of superiority of MiECC, worldwide penetration remains low due to concerns regarding air handling and volume management in the context of a closed system. The purpose of this study is to thoroughly investigate perfusion safety and technical feasibility of performing all cardiac surgical procedures with modular (hybrid) MiECC, as experienced from the perfusionist's perspective. METHODS: We retrospectively reviewed perfusion charts of consecutive adult patients undergoing all types of elective, urgent, and emergency cardiac surgery under modular MiECC. The primary outcome measure was perfusion safety and technical feasibility, as evidenced in the need for conversion from a closed to an open circuit. A systematic review of the literature was conducted aiming to ultimately clarify whether there are any safety issues regarding MiECC technology. RESULTS: We challenged modular MiECC use in a series of 403 consecutive patients of whom a significant proportion (111/403; 28%) underwent complex surgery including reoperations (4%), emergency repair of acute type A aortic dissection and composite aortic surgery (1.7%). Technical success rate was 100%. Conversion to an open circuit was required in 18/396 patients (4.5%), excluding procedures performed under circulatory arrest. Open configuration accounted for 40% ± 21% of total procedural perfusion time and was related to significant hemodilution and increase in peak lactate levels. Systematic review revealed that safety of the procedure challenged originated from a single report, while no clinical adverse event related to MiECC was identified. CONCLUSIONS: Use of modular MiECC secures safety and ensures technical feasibility in all cardiac surgical procedures. It represents a type III active closed system, while its stand-by component is reserved for a small (<5%) proportion of procedures and for a partial procedural time. Thus, it eliminates any safety concern regarding air handling and volume management, while it overcomes any unexpected intraoperative scenario.

Minimal invasive extracorporeal circulation preserves coagulation integrity.

INTRODUCTION: Coagulopathy after cardiac surgery is a serious multifactorial complication that results in postoperative bleeding requiring transfusion of red blood cells and procoagulant products. Use of cardiopulmonary bypass represents the major contributing factor affecting coagulation. We sought to prospectively investigate the effect of contemporary minimal invasive extracorporeal circulation (MiECC) on coagulation parameters using point-of-care (POC) rotational thromboelastometry and the relation to postoperative bleeding. METHODS: Patients undergoing elective cardiac surgery on MiECC were prospectively recruited. Anticoagulation strategy was based on individualized heparin management and heparin level-guided protamine titration. Rotational thromboelastometry testing was performed before induction of anesthesia and after aortic cross-clamp release. A strict POC-guided transfusion protocol was implemented. The primary endpoint was the assessment of viscoelastic properties of the coagulating blood at the end of surgery compared to preoperative values and the relation to postoperative bleeding and 24-hour transfusion requirements. RESULTS: Fifty patients were included in the study with a significant proportion having complex surgery. Thirteen patients (26%) required blood transfusion (mean rate: 0.5 ± 1 units per patient), 5/50 (10%) received coagulation factors while no patient received fresh frozen plasma, platelets or fibrinogen. Thromboelastometry analysis showed that the major derangement was CT EXTEM > 100 seconds in 28/50 (56%) and A10 EXTEM < 40 mm in one (2%) patient without clinical significance. Platelet function was preserved throughout surgery. A10-FIBTEM was found predictive of postoperative bleeding at 12 hours. CONCLUSIONS: MiECC preserves clot quality throughout surgery acting in both key determinants of clot strength; fibrinogen and platelets. This is clinically translated into minimal postoperative bleeding and restricted use of blood products and coagulation factors.

Minimal invasive extracorporeal circulation preserves platelet function after cardiac surgery: a prospective observational study.

INTRODUCTION: Cardiac surgery on conventional cardiopulmonary bypass induces a combination of thrombocytopenia and platelet dysfunction which is strongly related to postoperative bleeding. Minimal invasive extracorporeal circulation has been shown to preserve coagulation integrity, though effect on platelet function remains unclear. We aimed to prospectively investigate perioperative platelet function in a series of patients undergoing cardiac surgery on minimal invasive extracorporeal circulation using point-of-care testing. METHODS: A total of 57 patients undergoing elective cardiac surgery on minimal invasive extracorporeal circulation were prospectively recruited. Anticoagulation strategy was based on individualized heparin management and heparin level-guided protamine titration performed in all patients with a specialized point-of-care device (Hemostasis Management System - HMS Plus; Medtronic, Minneapolis, MN, USA). Platelet function was evaluated with impedance aggregometry using the ROTEM platelet (TEM International GmbH, Munich, Germany). ADPtest and TRAPtest values were assessed before surgery and after cardiopulmonary bypass. RESULTS: ADPtest value was preserved during surgery on minimal invasive extracorporeal circulation (58.2 ± 20 U vs. 53.6 ± 21 U; p = 0.1), while TRAPtest was found significantly increased (90 ± 27 U vs. 103 ± 38 U; p = 0.03). Postoperative ADPtest and TRAPtest values were inversely related to postoperative bleeding (correlation coefficient: -0.29; p = 0.03 for ADPtest and correlation coefficient: -0.28; p = 0.04 for TRAPtest). The preoperative use of P2Y12 inhibitors was identified as the only independent predictor of a low postoperative ADPtest value (OR = 15.3; p = 0.02). CONCLUSION: Cardiac surgery on minimal invasive extracorporeal circulation is a platelet preservation strategy, which contributes to the beneficial effect of minimal invasive extracorporeal circulation in coagulation integrity.

Quantification of Operational Learning in Minimal Invasive Extracorporeal Circulation.

Minimal invasive extracorporeal circulation (MiECC) has initiated important new efforts within science and technology towards a more physiologic perfusion. In this study, we aim to investigate the learning curve of our center regarding MiECC. We studied a series of 150 consecutive patients who underwent elective coronary artery bypass grafting by the same surgical team during the initial phase of MiECC application. Patients were randomly assigned into two groups. Group A (n = 75) included patients operated on MiECC, while group B (n = 75) included patients operated with conventional cardiopulmonary bypass (cCPB). The primary end-point of the study was to identify whether there is a learning curve when operating on MiECC. The following parameters were unrelated with increasing experience, even though the results favored MiECC use: reduced CPB duration (102.9 ± 25 vs. 122.2 ± 33 min, P <0.001), peak troponin release (0.07 ± 0.02 vs. 0.1 ± 0.04 ng/mL, P < 0.01), peak creatinine levels (0.97 ± 0.24 vs. 1.2 ± 0.3 mg/dL, P < 0.001), duration of mechanical ventilation (14.1 ± 7.2 vs. 36.9 ± 59.8 h, P < 0.01) and ICU stay (2.1 ± 0.7 vs. 4.4 ± 6.4 days, P < 0.01). However, need for intraoperative blood transfusion showed a trend towards a gradual decrease as experience with MiECC system was accumulating (R2 = 0.094, P = 0.007). Subsequently, operational learning applied to postoperative hematocrit and hemoglobin levels (R2 = 0.098, P = 0.006). We identified that advantages of MiECC technology in terms of reduced hemodilution and improved end-organ protection and clinical outcome are evident from the first patient. Optimal results are obtained with 50 cases; this refers mainly to significant reduction in the need for intraoperative blood transfusion. Teamwork from surgeons, anesthesiologists, and perfusionists is of paramount importance in order to maximize the clinical benefits from this technology.

A multidisciplinary perioperative strategy for attaining "more physiologic" cardiac surgery.

BACKGROUND: Cardiac surgery is, by definition, a "non-physiologic" intervention associated with systemic adverse effects. Despite advances in surgical technique, cardiopulmonary bypass (CPB) technology as well as anaesthesia management and patient care, there is still significant morbidity and subsequent mortality. AIM: We consider that the contemporary demand for further improving patient outcome mandates the upgrade from optimal perfusion during the procedure as the gold standard to the concept of a "more physiologic" cardiac surgery. Our policy is a multidisciplinary perioperative strategy based on goal-directed perfusion throughout surgery incorporating in-line monitoring. This translates to "prevent rather than correct" malperfusion through real-time adjustment rather than correction of derangement detected late by incremental evaluation. METHOD: The strategy is based on continuous monitoring of cardiac index, SvO2, DO2i, DO2i/VCO2i and rSO2. Data acquisition is followed by action when needed; this includes stepwise: transfusion, increase of cardiac output and initiation of inotropic/vasoactive support. Moreover, implementation of minimally invasive extracorporeal circulation (MiECC) is considered as a fundamental component of physiologic perfusion when on-CPB, providing improved circulatory support and end-organ protection. CONCLUSION: We consider that, with this strategy which establishes optimal perfusion perioperatively, we attain the goal of a "more physiologic" cardiac surgery.

Enhanced recovery after elective coronary revascularization surgery with minimal versus conventional extracorporeal circulation: a prospective randomized study.

OBJECTIVE: A minimal extracorporeal circulation (MECC) circuit integrates the advances in cardiopulmonary bypass (CPB) technology into a single circuit and is associated with improved short-term outcome. The aim of this study was to prospectively evaluate MECC compared with conventional CPB in facilitating fast-track recovery after elective coronary revascularization procedures. DESIGN: Prospective randomized study. SETTING: All patients scheduled for elective coronary artery surgery were evaluated, excluding those considered particularly high risk for fast-track failure. The fast-track protocol included careful preoperative patient selection, a fast-track anesthetic technique based on minimal administration of fentanyl, surgery at normothermia, early postoperative extubation in the cardiac recovery unit, and admission to the cardiothoracic ward within the first 24 hours postoperatively. PARTICIPANTS: One hundred twenty patients were assigned randomly into 2 groups (60 in each group). INTERVENTIONS: Group A included patients who were operated on using the MECC circuit, whereas patients in Group B underwent surgery on conventional CPB. MEASUREMENTS AND MAIN RESULTS: Incidence of fast-track recovery was significantly higher in patients undergoing MECC (25% v 6.7%, p = 0.006). MECC also was recognized as a strong independent predictor of early recovery, with an odds ratio of 3.8 (p = 0.011). Duration of mechanical ventilation and cardiac recovery unit stay were significantly lower in patients undergoing MECC together with the need for blood transfusion, duration of inotropic support, need for an intra-aortic balloon pump, and development of postoperative atrial fibrillation and renal failure. CONCLUSIONS: MECC promotes successful early recovery after elective coronary revascularization procedures, even in a nondedicated cardiac intensive care unit setting.

Use of minimized extracorporeal circulation system in noncoronary and valve cardiac surgical procedures-a case series.

The aim of this report is to explore application of minimized cardiopulmonary bypass (CPB) circuits in areas of cardiac surgery other than coronary bypass grafting and aortic valve surgery. We report three cases operated under minimal extracorporeal circulation support. Replacement of the descending thoracic aorta was performed in two patients; one with a descending aortic aneurysm and one with pseudoaneurysm formation after previous coarctation repair. We have also implanted a left ventricular assist device for destination therapy. The minimized extracorporeal circulation system provides optimal circulatory support, while it is associated with reduced postoperative morbidity, minimizing the side effects from the use of CPB. Moreover, when off-pump technique is attempted, it can be used as a standby circuit connected to the patient so as to enhance safety of the procedure. Minimized extracorporeal circulation systems can be used with safety and efficacy in a wide range of cardiac surgeries including descending aorta pathology and assist device implantation.

From less invasive to minimal invasive extracorporeal circulation.

Development of minimally invasive cardiac surgery (MICS) served the purpose of performing surgery while avoiding the surgical stress triggered by a full median sternotomy. Minimizing surgical trauma is associated with improved cosmesis and enhanced recovery leading to reduced morbidity. However, it has to be primarily appreciated that the extracorporeal circulation (ECC) stands for the basis of nearly all MICS procedures. With some fundamental modification and advancement in perfusion techniques, the use of ECC has become the enabling technology for the development of MICS. Less invasive cardiopulmonary bypass (CPB) techniques are based on remote cannulation and optimization of perfusion techniques with assisted venous drainage and use of centrifugal pump, so as to facilitate the demanding surgical maneuvers, rather than minimizing the invasiveness of the CPB. This is reflected in the increased duration of CPB required for MICS procedures. Minimal invasive Extracorporeal Circulation (MiECC) represents a major breakthrough in perfusion. It integrates all contemporary technological advancements that facilitate best applying cardiovascular physiology to intraoperative perfusion. Consequently, MiECC use translates to improved end-organ protection and clinical outcome, as evidenced in multiple clinical trials and meta-analyses. MICS performed with MiECC provides the basis for developing a multidisciplinary intraoperative strategy towards a "more physiologic" cardiac surgery by combining small surgical trauma with minimum body's physiology derangement. Integration of MiECC can advance MICS from non-full sternotomy for selected patients to a "more physiologic" surgery, which represents the real face of modern cardiac surgery in the transcatheter era.

Haematological effects of minimized compared to conventional extracorporeal circulation after coronary revascularization procedures.

During the last decade, minimized extracorporeal circulation (MECC) systems have shown beneficial effects to the patients over the conventional cardiopulmonary bypass (CECC) circuits. This is a prospective randomized study of 99 patients who underwent coronary artery bypass grafting (CABG) surgery, evaluating the postoperative haematological effects of these systems. Less haemodilution (p=0.001) and markedly less haemolysis (p<0.001), as well as better preservation of the coagulation system integrity (p=0.01), favouring the MECC group, was found. As a clinical result, less bank blood requirements were noted and a quicker recovery, as far as mechanical ventilation support and ICU stay are concerned, was evident with the use of MECC systems. As a conclusion, minimized extracorporeal circulation systems may attenuate the adverse effects of conventional circuits on the haematological profile of patients undergoing CABG surgery.

Minimally invasive extracorporeal circulation improves quality of life after coronary artery bypass grafting.

OBJECTIVES: The effect on postoperative health-related quality of life (HRQoL) after coronary artery bypass grafting (CABG) surgery with conventional cardiopulmonary bypass (cCPB) and off-pump surgery has been investigated extensively; however, there are no studies focusing on HRQoL after surgery with minimally invasive extracorporeal circulation (MiECC). Therefore, we sought to prospectively investigate the effect of MiECC on postoperative HRQoL when compared with cCPB in patients undergoing CABG over a short-term (3-month) follow-up period. METHODS: Sixty patients scheduled for elective CABG surgery were randomly assigned into two groups: those who had surgery on MiECC system (n = 30) and those who underwent CABG using cCPB (n = 30). Quality-of-life assessment was performed preoperatively (baseline-T0), at first postoperative month (T1) and at 3-month follow-up (T3). The RAND SF-36 scale was used for data collection, which included both sociodemographic and clinical characteristics of patients. The primary outcome of the study was quantitative measurement of postoperative HRQoL at 3-month follow-up. RESULTS: Both groups were balanced in terms of demographic, socio-economic and operative characteristics. At 3-month follow-up, mean SF-36 component and summary scores in each group were higher in absolute values than the respective mean baseline scores, apart from role-physical score in patients operated with cCPB. Patients operated on MiECC showed uniformly significantly higher values in all individual and summary domains, whereas patients operated on cCPB showed significant improvement in 6/8 individual domains. Patients operated on MiECC showed a more pronounced increase in SF-36 individual domain scores from the first to the third postoperative month when compared with cCPB, which was statistically significant regarding physical functioning (P = 0.001), role-physical (P < 0.001), vitality (P = 0.01) and role-emotional (P = 0.004). This resulted in a significant improvement in physical (P = 0.002) and mental (P = 0.01) summary scores. CONCLUSIONS: The current study proves that MiECC significantly improves HRQoL after coronary surgery compared with cCPB. This finding, combined with results from large-scale studies showing superior clinical outcomes from its use, enhances the role of MiECC as a dominant technique in coronary revascularization surgery.

Use of minimal invasive extracorporeal circulation in cardiac surgery: principles, definitions and potential benefits. A position paper from the Minimal invasive Extra-Corporeal Technologies international Society (MiECTiS).

Minimal invasive extracorporeal circulation (MiECC) systems have initiated important efforts within science and technology to further improve the biocompatibility of cardiopulmonary bypass components to minimize the adverse effects and improve end-organ protection. The Minimal invasive Extra-Corporeal Technologies international Society was founded to create an international forum for the exchange of ideas on clinical application and research of minimal invasive extracorporeal circulation technology. The present work is a consensus document developed to standardize the terminology and the definition of minimal invasive extracorporeal circulation technology as well as to provide recommendations for the clinical practice. The goal of this manuscript is to promote the use of MiECC systems into clinical practice as a multidisciplinary strategy involving cardiac surgeons, anaesthesiologists and perfusionists.

Use of minimal extracorporeal circulation improves outcome after heart surgery; a systematic review and meta-analysis of randomized controlled trials.

BACKGROUND: The question whether use of minimal extracorporeal circulation (MECC) influences patients' outcome remains unanswered. We performed a systemic review of the literature and a meta-analysis of randomized controlled trials to evaluate the impact of MECC compared to conventional extracorporeal circulation (CECC) on mortality and major adverse cardiovascular events in patients undergoing heart surgery. METHODS: We independently conducted a systemic review of English and non-English articles using Medline, Embase and Cochrane database. Random allocation to treatment with a minimum of 40 patients in both groups was considered mandatory for inclusion in the meta-analysis. Primary outcomes were operative mortality and major adverse cardiac and cerebrovascular events comprising death before discharge, myocardial infarction and neurologic damage. RESULTS: We included 24 studies comparing MECC vs. CECC with a total of 2770 patients. Use of MECC was associated with a significant decrease in mortality (0.5% vs. 1.7%, P=0.02), in the risk of postoperative myocardial infarction (1.0% vs. 3.8%, P=0.03) and reduced rate of neurologic events (2.3% vs. 4.0%, P=0.08). Additionally, MECC was associated with reduced systemic inflammatory response as measured by polymorphonuclear elastase, hemodilution as calculated by hematocrit drop after procedure, need for red blood cell transfusion, reduced levels of peak troponin release, incidence of low cardiac output syndrome, need for inotropic support, peak creatinine level, occurrence of postoperative atrial fibrillation, duration of mechanical ventilation and intensive care unit stay. CONCLUSIONS: Use of MECC in heart surgery resulted in improved short-term outcome as reflected by reduced mortality and morbidity compared with conventional extracorporeal circulation.