Minimally invasive extracorporeal circulation versus conventional cardiopulmonary bypass in patients undergoing cardiac surgery (MiECS): Rationale and design of a multicentre randomised trial.

INTRODUCTION: The ultimate answer to the question whether minimal invasive extracorporeal circulation (MiECC) represents the optimal perfusion technique in contemporary clinical practice remains elusive. The present study is a real-world study that focuses on specific perfusion-related clinical outcomes after cardiac surgery that could potentially be favourably affected by MiECC and thereby influence the future clinical practice. METHODS: The MiECS study is an international, multi-centre, two-arm randomized controlled trial. Patients undergoing elective or urgent coronary artery bypass grafting (CABG), aortic valve replacement (AVR) or combined procedure (CABG + AVR) using extracorporeal circulation will be randomized to MiECC or contemporary conventional cardiopulmonary bypass (cCPB). Use of optimized conventional circuits as controls is acceptable. The study design includes a range of features to prevent bias and is registered at clinicaltrials.gov (NCT05487612). RESULTS: The primary outcome is a composite of postoperative serious adverse events that could be related to perfusion technique occurring up to 30 days postoperatively. Secondary outcomes include use of blood products, ICU and hospital length of stay (30 days) as well as health-related quality of life (30 and 90 days). CONCLUSIONS: The MiECS trial has been designed to overcome perceived limitation of previous trials of MiECC. Results of the proposed study could affect current perfusion practice towards advancement of patient care.

Advancements in Donation after Circulatory Death Heart Procurement and Preservation: A Comprehensive Review of Recent Innovations.

INTRODUCTION: The persistent shortage of donor hearts for transplantation has prompted exploration into Donation after Circulatory Death (DCD) as a promising avenue for organ procurement. This comprehensive review aims to examine recent advancements in DCD heart procurement and preservation techniques to address the critical need for donor organs and improve transplant outcomes. MATERIALS AND METHODS: A systematic review was conducted to identify relevant studies and innovations related to DCD heart procurement and preservation. Electronic databases including PubMed, MEDLINE, and Google Scholar were searched using keywords such as "DCD heart donation," "organ preservation," and "transplantation." Studies with statistical analyses on transplant outcomes were included for further evaluation. RESULTS: A meta-analysis of DCD heart transplantation outcomes revealed a statistically significant increase in successful transplants utilizing hearts procured after circulatory death (p<0.05). Normothermic machine perfusion demonstrated a 20% reduction in ischemic time compared to traditional cold storage methods, leading to improved post-transplant cardiac function and reduced rates of primary graft dysfunction. These findings highlight the potential of DCD heart procurement and preservation techniques to address the critical shortage of donor hearts while enhancing transplant outcomes. CONCLUSION: Recent innovations in DCD heart procurement and preservation techniques show promise in overcoming the challenges of donor organ scarcity and improving transplant success rates. Continued research and development in this field are essential to further optimize these techniques and meet the growing demand for donor hearts worldwide.

Health Technology Assessment of Cardiopulmonary Bypass Circuit with and without Phosphorylcholine Coating: A Retrospective Study on Safety and Efficiency in Cardiac Surgery.

BACKGROUND: Phosphorylcholine has emerged as a potential adjunctive agent in cardiopulmonary bypass (CPB) circuits. Phosphorylcholine serves as a coating for the CPB circuit, potentially enhancing biocompatibility and reducing thrombotic events. However, its impact on specific patient populations and procedural outcomes remains underexplored. MATERIALS AND METHODS: In this retrospective study, we analyzed data from 60 patients who underwent cardiac surgery with CPB, comprising 20 cases each of coronary artery bypass grafting (CABG), mitral valve repair, and aortic valve replacement. The patient cohort was divided into two groups-30 patients whose CPB circuits were coated with phosphorylcholine (phosphorylcholine-coated group) and 30 patients who did not receive phosphorylcholine supplementation or circuit coating. Both groups underwent surgery with identical CPB circuit designs. We assessed the absence of adverse events, safety, and efficacy parameters, including blood loss, clotting, and the structural integrity of the CPB circuit. Additionally, we measured changes in mean albumin levels (g/dL), mean platelet counts (×109/L), and antithrombin III (ATIII) levels before and after CPB. RESULTS: The retrospective analysis revealed an absence of adverse events in both groups. In the phosphorylcholine-coated group compared to the non-phosphorylcholine-coated group, there was a notable difference in the delta change in mean albumin levels (0.87 ± 0.1 vs. 1.65 ± 0.2 g/dL, p-value 0.021), mean platelet counts (42.251 ± 0.121 vs. 54.21 ± 0.194 × 109/L, p-value 0.049), and ATIII levels (16.85 ± 0.2 vs. 31.21 ± 0.3 p-value 0.017). There was a notable reduction in the perioperative consumption of human complex units after CPB (3 vs. 12, p-value 0.019). CONCLUSIONS: Both groups, phosphorylcholine and non-phosphorylcholine, demonstrated the absence of adverse events and that the systems are safe for iatrogenic complication. Our findings suggest that the use of phosphorylcholine coating on the CPB circuit, in the absence of supplementary phosphorylcholine, in cardiac surgery is associated with favorable changes in mean albumin levels, mean platelet counts, and ATIII levels. Further research is warranted to elucidate the full extent of phosphorylcholine's impact on patient outcomes and CPB circuit performance.

Hemadsorption to Contain Postoperative Cell-Free Hemoglobin and Haptoglobin Preservation for Extended Cardiopulmonary Bypass Time in Cardiac Surgery for Acute Kidney Injuries Prevention.

INTRODUCTION: Prevention of acute kidney injury during cardiopulmonary bypass (CPB) is still a challenge and has been the object of numerous studies. The incidence of acute kidney injury in the context of CPB is related to a multifactorial etiology. The role of hemadsorption in relation to cell-free hemoglobin and haptoglobin preservation is not well defined in the literature on CPB during cardiac surgery procedures. METHODS: This is a single-center pilot randomized report including 20 patients undergoing elective CPB procedures with an expected time > 120 minutes for each extracorporeal procedure. Patients were randomly allocated to either standard of care (n=10) or Jafron HA380 (n=10) during CPB. The primary outcome measured was the incidence of postoperative acute kidney injuries. RESULTS: The Jafron study group vs. control group reported postoperative values for cell-free hemoglobin at 10 minutes after CPB (mg/L) (11.6 ± 0.6 vs. 29.9 ± 0.3) (P-value 0.021), haptoglobin 10 minutes after CPB (mg/dl) (129.16 ± 1.22 vs. 59.17 ± 1.49) (P-value 0.017), creatinine peak after CPB (mg/dL) (0.92 ± 0.17 vs. 1.32 ± 0.9) (P-value 0.030), and acute kidney injury after 48 hours (number of patients) (one vs. four) (P-value 0.027). CONCLUSION: This pilot study suggested that the use of Hemoperfusion Cartridge HA380 Jafron for extended CPB time for complex cardiac surgery procedures was safe and effective and is associated with a better postoperative preservation of haptoglobin with a reduction of cell-free hemoglobin values and less incidence of acute kidney injury, though larger studies are warranted to confirm our result.

Develop of endocavitary suction device for MiECC on minimally invasive mitral valve surgery.

The minimally invasive extracorporeal circulation (MiECC) system was developed to minimize the contact of blood with air and foreign surfaces during conventional cardiopulmonary bypass (CPB). It is also aimed to reduce the inflammatory response by further increasing the biocompatibility of the components that make up the MiECC circuits. The Minithoracotomy (MTH) approach for mitral valve disease remains associated with prolonged operative times, but it is beneficial in terms of reduced postoperative complications (renal failure, atrial fibrillation, blood transfusion, wound infection), length of stay in intensive care unit (ICU) and in hospitalization, with finally a reduction in global cost. Combining the use of the MiECC technique with minimally invasive mitral valve surgery (MIMVS) could open up new research scenarios. Although considerable progress has been made in the standardization of the surgical technique, limitations remain to be filled in the setting of Endo-cavitary aspiration for the association of MiECC with MIMVS. In this paper we introduce invention refers to a device and an air-closed endocavitary aspiration system for cardiac chamber surgery, as well as a method aimed at eliminating gaseous micro-embolic activity, hemolysis and CO2 aspiration and alteration of carbon dioxide production (VCO2) the parameters for goal directed perfusion. The system allows the surgery of the cardiac chambers to be associated with a minimally invasive extra-corporeal circulation circuit.

Hemadsorption to Contain Postoperative Cell-Free Hemoglobin and Haptoglobin Preservation for Extended Cardiopulmonary Bypass Time in Cardiac Surgery for Acute Kidney Injuries Prevention

ABSTRACT Introduction: Prevention of acute kidney injury during cardiopulmonary bypass (CPB) is still a challenge and has been the object of numerous studies. The incidence of acute kidney injury in the context of CPB is related to a multifactorial etiology. The role of hemadsorption in relation to cell-free hemoglobin and haptoglobin preservation is not well defined in the literature on CPB during cardiac surgery procedures. Methods: This is a single-center pilot randomized report including 20 patients undergoing elective CPB procedures with an expected time > 120 minutes for each extracorporeal procedure. Patients were randomly allocated to either standard of care (n=10) or Jafron HA380 (n=10) during CPB. The primary outcome measured was the incidence of postoperative acute kidney injuries. Results: The Jafron study group vs. control group reported postoperative values for cell-free hemoglobin at 10 minutes after CPB (mg/L) (11.6 ± 0.6 vs. 29.9 ± 0.3) (P-value 0.021), haptoglobin 10 minutes after CPB (mg/dl) (129.16 ± 1.22 vs. 59.17 ± 1.49) (P-value 0.017), creatinine peak after CPB (mg/dL) (0.92 ± 0.17 vs. 1.32 ± 0.9) (P-value 0.030), and acute kidney injury after 48 hours (number of patients) (one vs. four) (P-value 0.027). Conclusion: This pilot study suggested that the use of Hemoperfusion Cartridge HA380 Jafron for extended CPB time for complex cardiac surgery procedures was safe and effective and is associated with a better postoperative preservation of haptoglobin with a reduction of cell-free hemoglobin values and less incidence of acute kidney injury, though larger studies are warranted to confirm our result.

Emergent Conversion to Open Heart Surgery during Transcatheter Aortic Valve Implantation: The Presence of a Rescue Team Improves Outcomes.

OBJECTIVE: Transcatheter aortic valve implant (TAVI) is the gold standard for the high-surgical-risk group of patients with aortic valve disease and it is an alternative to surgery in patients at intermediate risk. Lethal complications can occur, and many of these are manageable only with emergent conversion to open heart surgery. We retrospectively evaluate the outcome of all patients undergoing TAVI in our departments and the impact of a complete cardiac rescue team to reduce 30-day mortality. METHODS: Data from all patients undergoing TAVI between January 2020 and August 2023 in our center were analyzed. An expert complete rescue was present in catheter laboratory. Primary outcomes were in-hospital and at 30-day mortality and evaluation of all cases needed for emergent conversion to open heart surgery. RESULTS: 825 patients were enrolled. The total mortality was 19/825 (2.3%). Eleven of the total patients (1.3%) required emergent conversion to open heart surgery. Among them, eight were alive (73%), with a theoretical decrease of 0.98% in overall mortality. CONCLUSIONS: surgical treatment is rare during TAVI. The presence of an expert complete rescue team as support means an increase in survival. Surgery must be used only to restore circulatory and to treat complication while percutaneous approaches should complete the procedure.

Infective Endocarditis After Percutaneous Device Closure of Atrial Septal Defects: Incidence, Diagnosis, and Treatment. Case Report and Literature Review.

Infective endocarditis (IE) on atrial septal defect (ASD) closure devices, while extremely rare, has been reported to be more frequent early after the procedure. We describe a case of late IE after percutaneous closure of patent foramen ovale (PFO). We also performed a literature review on this subject. We reviewed a total of 42,365 patients who were treated with percutaneous devices: 13,916 for ostium secundum (OS) (32%), 24,726 for PFO (58%) and 3,723 for OS+PFO (8%). Among these patients, we identified 50 cases of IE after atrial septal defect device closure (0.001%). In contrast to previous reports, nearly 66% of IE in this setting occurred late, after at least 6 months from the procedure (33/50 patients). A statistical analysis clearly showed that the mean time from the procedure to IE increased in the last five years, probably associated with a change in antiplatelet therapy after ASD closure. Management of IE on an ASD occluder should always be discussed in the setting of a multidisciplinary heart team that includes a cardiologist, cardiac surgeon, and anesthetist. While surgical strategies gave excellent results, conservative management might be considered in cases of small IE vegetations and for patients in good general condition. However, in these cases, the patient must be closely observed with repeated blood and instrumental tests.

Gaseous Micro-Embolic Activity and Goal-Directed Perfusion Management in a Closed System for Cardiopulmonary Bypass and Minimally Invasive Extracorporeal Circulation during Coronary Artery Bypass Grafting.

BACKGROUND: Cardiopulmonary bypass (CPB) techniques are becoming minimally invasive in clinical practice. The literature describes various extracorporeal techniques which seek to eliminate air-blood contact and reduce both hemodilution and the contact surface such as in Minimally invasive Extracorporeal Circulation (MiECC) and closed systems for CPB. However, the delivery of micro-embolic activity in the circuit and metabolic activity in terms of oxygen delivery for Goal-Directed Perfusion (GDP) management, in relation to the patient's blood volume and central venous pressure, have never been related and correlated. In this report, we present a cohort study that investigated these aspects between the closed SVR2000 System and modular MiECC (both from Eurosets SRL, Medolla, Italy). MATERIALS AND METHODS: Data were collected retrospectively and used to compare 60 consecutive patients who underwent isolated coronary artery bypass grafting (CABG) surgery by two surgeons using an SVR2000 oxygenator in 30 procedures, with a matched cohort of patients from the same period who underwent isolated CABG surgery by two other surgeons using a modular MiECC in 30 procedures. The primary endpoints collected were data on micro-embolic activity, including the number of gaseous micro-emboli in the circuit during the procedure, the mean maintenance value of oxygen delivery (DO2) and data relating to venous return volume and central venous pressure (CVP). RESULTS: During the CPB procedures, the following values were recorded for the closed SVR2000 and MiECC groups, respectively: the average number of gaseous micro-emboli (GME) in the venous line, 833 ± 23 vs 1221 ± 45 (p = 0.028); GME in the outlet of the pump, 375 ± 45 vs 429 ± 76 (p = 0.89; GME in the arterial line, 189 ± 36 vs 205 ± 27 (p = 0.92), and the volume of GME in the arterial line (mL), 0.32± 12 vs 0.49± 17 (p = 0.93). The mean Indexed Oxygen Delivery (DO2i) during cross-clamp (ml/min/m2) was 319 ±12 vs 278 ±9 (p = 0.0019), respectively. The maximum mean volume of venous return in the soft-shell venous reservoir (ml) was 1801 ±128 vs 824 ±192 (p = 0.038). The mean central venous pressure (CVP) during cross-clamp (mmHg) was 0 ± 2 vs 6 ± 2 (p = 0.019). CONCLUSIONS: In this study, the results in the closed SVR2000 group were not statistically inferior to those in the modular MiECC group in terms of gaseous micro-embolic activity during CPB. Our analysis showed an important reduction of GME delivery in both systems. The closed SVR2000 group showed better management for GDP in terms of DO2i, associated with the flexibility of dynamic volume management and the absence of cavitation and regulation of the rate per minute and pump flow, which were reported in the MiECC group. The SVR2000 and modular MiECC systems were both safe and effective in perioperative practice without iatrogenic problems.

Cardiopulmonary Bypass Settings for the Prevention of Early Hypotension During CABG.

BACKGROUND: Vasoplegic syndrome is a form of vasodilatory shock that can occur before, during or after cardiopulmonary bypass (CPB). We introduce a strategy to reduce the incidence of early hypotension phenomena during Coronary Artery Bypass Graft (CABG) procedures. MATERIALS AND METHODS: In this prospective cohort study, 100 patients underwent elective CABG with two perioperative CPB settings. The study group (50 patients) was managed with retrograde autologous priming (RAP), 3-minute stepwise for the institution of CPB, and pulsatile flow (PP). The control group (50 patients) was managed without RAP, with the rapid initiation of CPB, and non-pulsatile (NP) flow. The primary endpoints were MAP (mmHg), number of hypotensive phenomena (MAP < 50 mmHg for > 30 sec), the venous return volume on CPB (ml), the cardiac index (L/min/m2), hemoglobin (g/dL), indexed oxygen delivery (DO2i, ml/min/m2), the systemic vascular resistance index (SVRI, dynes s m2/cm5), number of 1-ml boluses of a vasoactive substance (norepinephrine), the positive fluid balance (ml), and the number of red blood cell units for transfusion. RESULTS: During CPB, the mean values in the study and control groups were as follows: MAP, 68± 7 vs 56 ± 7 (p-value, 0.0019); hypotensive phenomena, 3 ± 1 vs 8 ±2 (p-value, 0.019); venous return volume, 840±79 vs 1129 ±123 (p-value, 0.0017); cardiac index, 2.4 ± 0.4 vs 2.7 ±0.2 (p-value, 0.0023); hemoglobin, 9.13 ± 0.29 vs 7.8± 0.23 (p-value, 0.0001); DO2i, 301± 12 vs 276±23 (p-value, 0.0011); SVRI, 1879 ±280 vs 2210 ±140 (p-value, 0.0017); norepinephrine, 1±2 vs 8 ±3 (p-value, 0.0023); positive fluid balance, 750 ±212 vs 1450 ±220 (p-value, 0.005); and total number of red blood cell units for transfusion, 16 ±4.2 vs 27 ± 5.3 (p-value, 0.008). CONCLUSIONS: In this prospective cohort study, during CPB, the study group showed a better preservation of MAP, SVRI, and DO2i, and a reduction of vasoconstrictor use in a CPB setting with the RAP technique, 3-minute stepwise for the initiation of CPB and pulsatile pump flow, compared to the control group. Further studies are needed to validate this perioperative approach to CPB.

Minimal invasive extracorporeal circulation an alternative to ECMO in ventricular tachycardia ablation.

BACKGROUND: The advantages of mechanical assistance during ventricular tachycardia (VT) ablation have not been clinically demonstrated. We propose and discuss a technique, set up by us, that makes use of minimally invasive extra-corporeal circulation (MiECC) type III associated with a venous reservoir system, which allows complete cardiac flow support and blood oxygenation as well as hemodynamic stability during long-lasting procedures. METHODS: We present a retrospective case series of ten patients with valvular heart disease and unresponsive Ventricular Tachycardia (VT) who underwent VT ablation with MiECC support. The mean age of the patients was 72 ± 8 years and the left ventricular ejection fraction was 36 ± 12%. All patients underwent a clinical evaluation to identify the cause of VT unresponsiveness (e.g., ischemic heart disease). RESULTS: A total of 140 min, the following parameters were evaluated and recorded for 140 min. Central venous pressure (CVP) was used to evaluate excess volume. During the first 5 min, the mean was 15 mmHg, with a pump flow of 1.5 L/min and a mean systemic arterial pressure of 100 mmHg while setting up the circulation support. Following drainage in a volumetric bag of 1 L of blood, CVP was reduced to a value of 5 mmHg with a flow rate of 5 L/min and a mean systemic arterial pressure of 65 mmHg. In the case of small and low-weight patients our "1 L protocol" can be modified. CONCLUSIONS: In this preliminary retrospective case series, the MiECC type III system may represent the ideal support system during VT ablation, and further studies are needed to support this preliminary report.