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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.
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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.
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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.
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Injúria Renal Aguda , Ponte Cardiopulmonar , Haptoglobinas , Hemoglobinas , Humanos , Injúria Renal Aguda/prevenção & controle , Injúria Renal Aguda/etiologia , Haptoglobinas/análise , Ponte Cardiopulmonar/efeitos adversos , Ponte Cardiopulmonar/métodos , Masculino , Projetos Piloto , Feminino , Pessoa de Meia-Idade , Hemoglobinas/análise , Idoso , Fatores de Tempo , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Procedimentos Cirúrgicos Cardíacos/métodos , Complicações Pós-Operatórias/prevenção & controle , Período Pós-Operatório , Resultado do TratamentoRESUMO
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.
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Procedimentos Cirúrgicos Cardíacos , Valva Mitral , Humanos , Valva Mitral/cirurgia , Sucção , Resultado do Tratamento , Circulação Extracorpórea/métodos , Procedimentos Cirúrgicos Cardíacos/métodos , Procedimentos Cirúrgicos Minimamente Invasivos/métodosRESUMO
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.
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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.
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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.
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BACKGROUND: Transport with extracorporeal membrane oxygenation (ECMO) in the hospital setting can become a challenge as well as in the out-of-hospital setting. In particular, the management of intra-hospital transport with ECMO support of the critically ill patient foresees his shift from the intensive care to the diagnostic areas, from the diagnostic areas to the interventional and surgical areas. CASE PRESENTATION: In this context, we present a life-saving transport case with the veno-venous (VV) configuration of the ECMOLIFE Eurosets system, for right heart and respiratory failure in a 54-year-old woman, due to thrombosed obstruction of the right superior pulmonary vein, following mitral valve repair surgery in minimally invasive approach in a patient already operated on for complex congenital heart disease. After stabilizing the vital parameters with Veno-venous ECMO for 19 h, the patient was transported to hemodynamics for angiography of the pulmonary vessels, where the diagnosis of obstruction of the pulmonary venous return was made. Subsequently, the patient was brought back to the operating room for a procedure of unblocking the right superior pulmonary vein using a minimally invasive approach, passing from the ECMO to the support in extracorporeal circulation. CONCLUSIONS: The transportable ECMOLIFE Eurosets System was safe and effective during transport in maintaining the vital parameters of oxygenation and CO2 reuptake and systemic flow, allowing the patient to be mobilized for diagnostic tests instrumental to diagnosis. The patient was extubated 36 h after the surgical procedures and was discharged 10 days later from the hospital.
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The equipment selected for cardiopulmonary bypass (CPB) in pediatric cardiac surgery critically influences the safety, efficiency, efficacy and pathophysiological impact in perioperative use and the post-operative outcome. In this report, we present a single-center retrospective analysis of the clinical efficacy, efficiency and safety of the Trilly oxygenator (Eurosets Srl, Medolla, MO, Italy), which has an integrated arterial filter. It has a blood flow capacity of 500 to 3500ml/min, an AAMI index of 4.000ml / min, and a static fill prime (oxygenating module + heat exchanger) of 130 ml. We used this device on 42 pediatric patients who underwent repair of various congenital heart defects with cardiopulmonary bypass. Pre- and intraoperative patient data were collected for the evaluation of gas transfer and metabolic parameters in relation to blood flow, temperature and hematologic profiles. The mean age of the patients was 8.07 ± 2.9 years. Eight patients had cyanotic heart disease, 7 had chromosomal abnormalities and 9 had previously undergone cardiac surgery. The STAT Mortality Category Score was distributed as follows: Cat. 1 (37.5%), Cat. 2 (35%), Cat. 3 (5%), Cat. 4 (22.5%), Cat. 5 (0%). The mean bodyweight was 29.03 ± 8.25 kg and the blood flow rate was 2664.88 ± 508.43 ml / min. The mean cardiopulmonary bypass time was 95±51.4 min and the cross-clamp time was 37±34.6 min. The mean gas transfer values were as follows: partial pressure of oxygen, post oxygenator, 224.7±28 mmHg; partial pressure of carbon dioxide, post oxygenator, 42±4 mmHg; oxygen delivery 356.9± 88.8 ml/min/m2; carbon dioxide transfer, 52.81± 1.98 mmHg, mixed venous saturation 77.78 %; and mean hematocrit value 29.0±4 %. The Trilly oxygenator was effective in terms of oxygen uptake, carbon dioxide removal, and heat exchange in a pediatric population undergoing cardiopulmonary bypass. This retrospective analysis showed that the Trilly is both safe and effective in clinical practice without iatrogenic problems.
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BACKGROUND: Studies reporting on the outcome of 90-year-old patients undergoing cardiac surgery are scant in literature; and currently, those regarding the implementation of trans-catheter techniques number even fewer. METHODS: We compared patients aged >89 years operated on between 1998 and 2008 at 8 Italian cardiac surgery centers, with patients of the same age operated on between 2009 and 2021. All of the patients were operated on with "open" surgery, with the exclusion of percutaneous valve repair/implantation procedures. RESULTS: The patients of the two groups (group 98-08-127 patients, and group 09-21-101 patients) had comparable preoperative risk factors in terms of the LogEuroSCORE (98-08: 21.3 ± 6.1 vs. 09-21: 20.9 ± 11.1, p = 0.12). There was a considerable difference in the type of surgery (isolated valve, isolated coronary, and combined surgery, 46.5, 38.5, and 15% vs. 52, 13, and 35% in 98-08 and 09-21, respectively, p = 0.01). Analogous operating durations were recorded (cross-clamp time: 98-08: 46 ± 28 min vs. 09-21: 51 ± 28 min, p = 0.06). The number of packed bypasses was lower in 09-21 (1.3 ± 0.6 vs. 2.4 ± 1.2, p = 0.001). In the postoperative period, there was a statistically significant difference in the 30-day survival in favor of the "more recent" patients (98-08: 17 deaths (13.4%) versus 09-21: 6(5.9%); p = 0.001), also confirmed in the subgroups (12.2% vs. 0% in isolated coronary surgery, p < 0.001; and 12.3% vs. 0% in isolated valve surgery, p < 0.001). CONCLUSIONS: Accurate pre-, intra-, and post-operative evaluation/management to reduce biological impacts facilitate significant improvements in the outcomes in nonagenarian patients when compared to the results recorded in previous years.
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BACKGROUND: Drainage of fluid and evacuation of air from the pericardial and pleural spaces after cardiothoracic surgery is necessary to prevent effusion, tamponade, and pneumothorax, and also to detect hemorrhage. For this purpose, negative-pressure drains are placed in the mediastinum and pleural cavities. We compared the efficacy and safety of two systems wet and dry drainage for the management and monitoring of negative pressure and anti-reflux valve safety systems, to promote healing of the pleural and pericardial cavities. METHODS: Two devices for mediastinal chest drainage [Venice PAS (Wet) and Rome PAS (Dry); both Eurosets SRL, Medolla, Italy] were evaluated in terms of safety, efficacy and clinical outcomes in a cohort of 60 patients who underwent elective cardiac surgery procedures. The patients were divided into a minimally invasive cardiac surgery (MICS) group [n=30; mitral valve surgery (MVS) by right anterolateral mini-thoracotomy] and a conventional cardiac surgery (CCS) group [n=30; coronary arterial bypass grafting (CABG) in full sternotomy] at a single institution (Anthea Hospital GVM Care & Research, Bari, Italy). RESULTS: Negative pressure was managed with a target value of -20 cmH2O measured in the chest tube and was related to the device: deviation of ± 1 cmH2O for the Venice PAS (Wet) and 0 cmH2O for the Rome PAS (Dry) in the MICS group; deviation of 1 ± 0.8 cmH2O for the Venice PAS (Wet) and 0.8±0.2 cmH2O for the Rome PAS (Dry) in the CCS group. A constant volumetric air leak meter (VALM) value and the absence of air-leak bubbling were correlated with the absence of air in the pleural cavity and complete pulmonary re-expansion to restore normal respiratory dynamics in the MICS group for both models of chest drainage. The maximum total pericardial blood drained was 1104 ± 302 ml with Venice PAS (Wet) and 1530 ± 230 with Rome PAS (Dry) in the CCS group. There were no reports of cardiac tamponade in either group. CONCLUSIONS: The two mediastinal chest drainage devices [Venice PAS (Wet) and Rome PAS (Dry)] in this study were effective, accurate for measuring the applied negative pressure, and safe in their application after cardiac surgery procedures via minimally invasive and conventional approaches for blood and liquid drainage, prevention of cardiac tamponade, and restoration of normal respiratory dynamics after surgical pneumothorax. Both systems are equipped with anti-reflux valves to prevent air and blood from entering the drainage, and no adverse events were reported.