Autologous blood salvage in cardiac surgery: clinical evaluation, efficacy and levels of residual heparin

ABSTRACT Objective: Intraoperative blood salvage (cell saver technique) in cardiac surgery is universally used in surgical procedures with a marked risk of blood loss. The primary objectives of this study were to determine the concentration of residual heparin in the final product that is reinfused into the patient in the operating room and to evaluate the efficacy and safety of the cell saver technique. Method: Twelve patients undergoing elective cardiac surgery were enrolled in this study. Using the XTRA Autotransfusion System, blood samples were collected from the cardiotomy reservoir, both prior to blood processing (pre-sample) and after it, directly from the bag with processed product (post-sample). Hematocrit and hemoglobin levels, the protein, albumin and residual heparin concentrations, hemolysis index, and the platelet, erythrocyte and leukocyte counts were measured. Results: Hematocrit and hemoglobin levels and red blood cell counts were higher in post-processing samples, with a mean variation of 54.78%, 19.81 g/dl and 6.84 × 106/mm3, respectively (p < 0.001). The mean hematocrit of the processed bag was 63.49 g/dl (range: 57.2-67.5). The residual heparin levels were ≤0.1 IU/ml in all post-treatment analyses (p = 0.003). No related adverse events were observed. Conclusion: The reduced residual heparin values (≤0.1 IU/ml) in processed blood found in this study are extremely important, as they are consistent with the American Association of Blood Banks guidelines, which establish target values below 0.5 IU/ml. The procedure was effective, safe and compliant with legal requirements and the available international literature.

Autologous blood salvage in cardiac surgery: clinical evaluation, efficacy and levels of residual heparin.

OBJECTIVE: Intraoperative blood salvage (cell saver technique) in cardiac surgery is universally used in surgical procedures with a marked risk of blood loss. The primary objectives of this study were to determine the concentration of residual heparin in the final product that is reinfused into the patient in the operating room and to evaluate the efficacy and safety of the cell saver technique. METHOD: Twelve patients undergoing elective cardiac surgery were enrolled in this study. Using the XTRA Autotransfusion System, blood samples were collected from the cardiotomy reservoir, both prior to blood processing (pre-sample) and after it, directly from the bag with processed product (post-sample). Hematocrit and hemoglobin levels, the protein, albumin and residual heparin concentrations, hemolysis index, and the platelet, erythrocyte and leukocyte counts were measured. RESULTS: Hematocrit and hemoglobin levels and red blood cell counts were higher in post-processing samples, with a mean variation of 54.78%, 19.81g/dl and 6.84×106/mm3, respectively (p<0.001). The mean hematocrit of the processed bag was 63.49 g/dl (range: 57.2-67.5). The residual heparin levels were ≤0.1IU/ml in all post-treatment analyses (p=0.003). No related adverse events were observed. CONCLUSION: The reduced residual heparin values (≤0.1IU/ml) in processed blood found in this study are extremely important, as they are consistent with the American Association of Blood Banks guidelines, which establish target values below 0.5IU/ml. The procedure was effective, safe and compliant with legal requirements and the available international literature.

Coronary artery bypass surgery in Brazil: analysis of the national reality through the bypass registry

Abstract Introduction: Coronary artery bypass grafting (CABG) is the most frequently performed heart surgery in Brazil. Recent international guidelines recommend that national societies establish a database on the practice and results of CABG. In anticipation of the recommendation, the BYPASS Registry was introduced in 2015. Objective: To analyze the profile, risk factors and outcomes of patients undergoing CABG in Brazil, as well as to examine the predominant surgical strategy, based on the data included in the BYPASS Registry. Methods: A cross-sectional study of 2292 patients undergoing CABG surgery and cataloged in the BYPASS Registry up to November 2018. Demographic data, clinical presentation, operative variables, and postoperative hospital outcomes were analyzed. Results: Patients referred to CABG in Brazil are predominantly male (71%), with prior myocardial infarction in 41.1% of cases, diabetes in 42.5%, and ejection fraction lower than 40% in 9.7%. The Heart Team indicated surgery in 32.9% of the cases. Most of the patients underwent cardiopulmonary bypass (87%), and cardioplegia was the strategy of myocardial protection chosen in 95.2% of the cases. The left internal thoracic artery was used as a graft in 91% of the cases; the right internal thoracic artery, in 5.6%; and the radial artery in 1.1%. The saphenous vein graft was used in 84.1% of the patients, being the only graft employed in 7.7% of the patients. The median number of coronary vessels treated was 3. Operative mortality was 2.8%, and the incidence of cerebrovascular accident was 1.2%. Conclusion: CABG data in Brazil provided by the BYPASS Registry analysis are representative of our national reality and practice. This database constitutes an important reference for indications and comparisons of therapeutic procedures, as well as to propose subsequent models to improve patient safety and the quality of surgical practice in the country.

Coronary Artery Bypass Surgery in Brazil: Analysis of the National Reality Through the BYPASS Registry.

INTRODUCTION: Coronary artery bypass grafting (CABG) is the most frequently performed heart surgery in Brazil. Recent international guidelines recommend that national societies establish a database on the practice and results of CABG. In anticipation of the recommendation, the BYPASS Registry was introduced in 2015. OBJECTIVE: To analyze the profile, risk factors and outcomes of patients undergoing CABG in Brazil, as well as to examine the predominant surgical strategy, based on the data included in the BYPASS Registry. METHODS: A cross-sectional study of 2292 patients undergoing CABG surgery and cataloged in the BYPASS Registry up to November 2018. Demographic data, clinical presentation, operative variables, and postoperative hospital outcomes were analyzed. RESULTS: Patients referred to CABG in Brazil are predominantly male (71%), with prior myocardial infarction in 41.1% of cases, diabetes in 42.5%, and ejection fraction lower than 40% in 9.7%. The Heart Team indicated surgery in 32.9% of the cases. Most of the patients underwent cardiopulmonary bypass (87%), and cardioplegia was the strategy of myocardial protection chosen in 95.2% of the cases. The left internal thoracic artery was used as a graft in 91% of the cases; the right internal thoracic artery, in 5.6%; and the radial artery in 1.1%. The saphenous vein graft was used in 84.1% of the patients, being the only graft employed in 7.7% of the patients. The median number of coronary vessels treated was 3. Operative mortality was 2.8%, and the incidence of cerebrovascular accident was 1.2%. CONCLUSION: CABG data in Brazil provided by the BYPASS Registry analysis are representative of our national reality and practice. This database constitutes an important reference for indications and comparisons of therapeutic procedures, as well as to propose subsequent models to improve patient safety and the quality of surgical practice in the country.

Evolução no tratamento dos aneurismas da aorta torácica / Evolution and treatment of throracic aortic aneurysms

Os autores realizam uma revisão, de característica didática, das aortopatias, focalizando o histórico, o desenvolvimento do tratamento e os aspectos atuais de abordagem, utilizando a alta tecnologia das salas híbridas. Nos últimos anos, graças ao desenvolvimento das técnicas endovasculares, ocorreu uma verdadeira revolução no tratamento, especialmente para as patologias da aorta descendente, em que procedimentos eficientes foram aplicados com acentuada redução da morbimortalidade. A utilização de salas híbridas e tecnologia de moldes 3D, permitindo endoprótese customizadas, constituem-se em avanços significativos a serem utilizados nos próximos anos e que mudarão os paradigmas de uma subespecialidade

The authors performed a didactic review of aortic diseases, focusing on the historical aspects, the development of treatment, and aspects of the current approach using the latest technology of hybrid surgical rooms. In recent years, thanks to the development of endovascular techniques, there has been a real treatment revolution, especially for diseases of the descending aorta, with the application of efficient procedures, resulting in a significant reduction in morbidity and mortality. The use of hybrid technology rooms and computer 3-D reconstruction technology, enabling customized endoprostheses, are significant advances to be used in the coming years, and that will change the paradigms of a sub-specialty.

The Brazilian Registry of Adult Patient Undergoing Cardiovascular Surgery, the BYPASS Project: Results of the First 1,722 Patients.

Objective: To report the early results of the BYPASS project - the Brazilian registrY of adult Patient undergoing cArdiovaScular Surgery - a national, observational, prospective, and longitudinal follow-up registry, aiming to chart a profile of patients undergoing cardiovascular surgery in Brazil, assessing the data harvested from the initial 1,722 patients. Methods: Data collection involved institutions throughout the whole country, comprising 17 centers in 4 regions: Southeast (8), Northeast (5), South (3), and Center-West (1). The study population consists of patients over 18 years of age, and the types of operations recorded were: coronary artery bypass graft (CABG), mitral valve, aortic valve (either conventional or transcatheter), surgical correction of atrial fibrillation, cardiac transplantation, mechanical circulatory support and congenital heart diseases in adults. Results: 83.1% of patients came from the public health system (SUS), 9.6% from the supplemental (private insurance) healthcare systems; and 7.3% from private (out-of -pocket) clinic. Male patients comprised 66%, 30% were diabetics, 46% had dyslipidemia, 28% previously sustained a myocardial infarction, and 9.4% underwent prior cardiovascular surgery. Patients underwent coronary artery bypass surgery were 54.1% and 31.5% to valve surgery, either isolated or combined. The overall postoperative mortality up to the 7th postoperative day was 4%; for CABG was 2.6%, and for valve operations, 4.4%. Conclusion: This first report outlines the consecution of the Brazilian surgical cardiac database, intended to serve primarily as a tool for providing information for clinical improvement and patient safety and constitute a basis for production of research protocols.

The brazilian registry of adult patient undergoing cardiovascular surgery, the bypass project: results of the first 1,722 patients

Abstract Objective: To report the early results of the BYPASS project - the Brazilian registrY of adult Patient undergoing cArdiovaScular Surgery - a national, observational, prospective, and longitudinal follow-up registry, aiming to chart a profile of patients undergoing cardiovascular surgery in Brazil, assessing the data harvested from the initial 1,722 patients. Methods: Data collection involved institutions throughout the whole country, comprising 17 centers in 4 regions: Southeast (8), Northeast (5), South (3), and Center-West (1). The study population consists of patients over 18 years of age, and the types of operations recorded were: coronary artery bypass graft (CABG), mitral valve, aortic valve (either conventional or transcatheter), surgical correction of atrial fibrillation, cardiac transplantation, mechanical circulatory support and congenital heart diseases in adults. Results: 83.1% of patients came from the public health system (SUS), 9.6% from the supplemental (private insurance) healthcare systems; and 7.3% from private (out-of -pocket) clinic. Male patients comprised 66%, 30% were diabetics, 46% had dyslipidemia, 28% previously sustained a myocardial infarction, and 9.4% underwent prior cardiovascular surgery. Patients underwent coronary artery bypass surgery were 54.1% and 31.5% to valve surgery, either isolated or combined. The overall postoperative mortality up to the 7th postoperative day was 4%; for CABG was 2.6%, and for valve operations, 4.4%. Conclusion: This first report outlines the consecution of the Brazilian surgical cardiac database, intended to serve primarily as a tool for providing information for clinical improvement and patient safety and constitute a basis for production of research protocols.

Mitral implant of the Inovare transcatheter heart valve in failed surgical bioprostheses: a novel alternative for valve-in-valve procedures.

Objectives: Reoperative procedure for the treatment of a failed mitral bioprosthesis is associated with considerable risk. In some cases, mortality is high and might contraindicate the benefit of the procedure. The minimally invasive valve-in-valve (ViV) transcatheter mitral valve implant offers an alternative less-invasive approach, reducing morbidity and mortality. The objective of this paper was to evaluate the mitral ViV approach using the Braile Inovare prosthesis. Methods: The transcatheter balloon-expandable Braile Inovare prosthesis was used in 12 cases. Procedures were performed in a hybrid operating room, under fluoroscopic and echocardiographic control. Through left minithoracotomy, the prostheses were implanted through the cardiac apex. Serial echocardiographic and clinical examinations were performed. Follow-up varied from 1 to 30 months. Results: A total of 12 transapical mitral ViV procedures were performed. Patients had a mean age of 61.6 ± 9.9 years and 92% were women. Mean logistic EuroSCORE was 20.1%. Successful valve implantation was possible in all cases. In one case, a right lateral thoracotomy was performed for the removal of an embolized prosthesis. There was no operative mortality. Thirty-day mortality was 8.3%. Ejection fraction was preserved after the implant (66.7%; 64.8%; P = 0.3). The mitral gradient showed a significant reduction (11 mmHg; 6 mmHg; P < 0.001). Residual mitral regurgitation was not present. There was no left ventricular outflow tract obstruction. Conclusions: The mitral ViV implant in a failed bioprosthesis is an effective procedure. This possibility might alter prosthesis selection in the future initial surgical prosthesis selection, favouring bioprostheses. Further large trials should explore its safety.

Analysis of the Use of Extracorporeal Circulation on the In-Hospital Outcomes of Dialytic Patients Who Underwent Myocardial Revascularization Surgery / Análise do Uso da Circulação Extracorpórea na Evolução Intra-Hospitalar de Pacientes Dialíticos Submetidos à Revascularização Cirúrgica do Miocárdio

Abstract Background: Myocardial revascularization surgery is the best treatment for dyalitic patients with multivessel coronary disease. However, the procedure still has high morbidity and mortality. The use of extracorporeal circulation (ECC) can have a negative impact on the in-hospital outcomes of these patients. Objectives: To evaluate the differences between the techniques with ECC and without ECC during the in-hospital course of dialytic patients who underwent surgical myocardial revascularization. Methods: Unicentric study on 102 consecutive, unselected dialytic patients, who underwent myocardial revascularization surgery in a tertiary university hospital from 2007 to 2014. Results: Sixty-three patients underwent surgery with ECC and 39 without ECC. A high prevalence of cardiovascular risk factors was found in both groups, without statistically significant difference between them. The group "without ECC" had greater number of revascularizations (2.4 vs. 1.7; p <0.0001) and increased need for blood components (77.7% vs. 25.6%; p <0.0001) and inotropic support (82.5% vs 35.8%; p <0.0001). In the postoperative course, the group "without ECC" required less vasoactive drugs, (61.5% vs. 82.5%; p = 0.0340) and shorter time of mechanical ventilation (13.0 hours vs. 36,3 hours, p = 0.0217), had higher extubation rates in the operating room (58.9% vs. 23.8%, p = 0.0006), lower infection rates (7.6% vs. 28.5%; p = 0.0120), and shorter ICU stay (5.2 days vs. 8.1 days; p = 0.0054) as compared with the group with ECC surgery. No difference in mortality was found between the groups. Conclusion: Myocardial revascularization with ECC in patients on dialysis resulted in higher morbidity in the perioperative period in comparison with the procedure without ECC, with no difference in mortality though.

Resumo Fundamento: A revascularização cirúrgica do miocárdio é o melhor tratamento para o paciente dialítico com doença coronariana multiarterial. Contudo, o procedimento ainda apresenta elevada morbimortalidade. O uso da circulação extracorpórea (CEC) pode impactar de maneira negativa na evolução intra-hospitalar desses pacientes. Objetivos: Avaliar a diferença entre as técnicas com ou sem CEC na evolução intra-hospitalar de pacientes dialíticos submetidos a cirurgia de revascularização do miocárdio. Métodos: Estudo unicêntrico de 102 pacientes dialíticos consecutivos e não selecionados, submetidos à revascularização cirúrgica do miocárdio em um hospital terciário universitário no período de 2007 a 2014. Resultados: 63 pacientes foram operados com CEC e 39 sem o uso de CEC. Foi observada alta prevalência de fatores de risco cardiovascular em ambos grupos, porém sem diferença estatisticamente significante entre eles. O grupo "com CEC" apresentou maior número de coronárias revascularizadas (2,4 vs 1,7; p <0,0001), maior necessidade de hemocomponentes (77,7% vs 25,6%; p <0,0001) e apoio inotrópico (82,5% vs 35,8%; p <0,0001). Na evolução pós-operatória, o grupo "sem CEC" apresentou menor necessidade de drogas vasoativas (61,5% vs 82,5%; p = 0,0340), maior taxa de extubação em sala cirúrgica (58,9% vs 23,8%, p = 0,0006), menor tempo de ventilação mecânica (13,0 horas vs 36,3 horas, p = 0,0217), menor taxa de infecções (7,6% vs 28,5%; p = 0,0120) e menor tempo de internação em UTI (5,2 dias vs 8,1 dias; p = 0,0054) em comparação ao grupo "com CEC". Não houve diferença de mortalidade entre os grupos. Conclusão: O uso da CEC na revascularização do miocárdio em pacientes dialíticos resultou em maior morbidade no período perioperatório em comparação ao procedimento realizado sem CEC, contudo, sem diferença de mortalidade.

Analysis of the Use of Extracorporeal Circulation on the In-Hospital Outcomes of Dialytic Patients Who Underwent Myocardial Revascularization Surgery.

BACKGROUND: Myocardial revascularization surgery is the best treatment for dyalitic patients with multivessel coronary disease. However, the procedure still has high morbidity and mortality. The use of extracorporeal circulation (ECC) can have a negative impact on the in-hospital outcomes of these patients. OBJECTIVES: To evaluate the differences between the techniques with ECC and without ECC during the in-hospital course of dialytic patients who underwent surgical myocardial revascularization. METHODS: Unicentric study on 102 consecutive, unselected dialytic patients, who underwent myocardial revascularization surgery in a tertiary university hospital from 2007 to 2014. RESULTS: Sixty-three patients underwent surgery with ECC and 39 without ECC. A high prevalence of cardiovascular risk factors was found in both groups, without statistically significant difference between them. The group "without ECC" had greater number of revascularizations (2.4 vs. 1.7; p <0.0001) and increased need for blood components (77.7% vs. 25.6%; p <0.0001) and inotropic support (82.5% vs 35.8%; p <0.0001). In the postoperative course, the group "without ECC" required less vasoactive drugs, (61.5% vs. 82.5%; p = 0.0340) and shorter time of mechanical ventilation (13.0 hours vs. 36,3 hours, p = 0.0217), had higher extubation rates in the operating room (58.9% vs. 23.8%, p = 0.0006), lower infection rates (7.6% vs. 28.5%; p = 0.0120), and shorter ICU stay (5.2 days vs. 8.1 days; p = 0.0054) as compared with the group with ECC surgery. No difference in mortality was found between the groups. CONCLUSION: Myocardial revascularization with ECC in patients on dialysis resulted in higher morbidity in the perioperative period in comparison with the procedure without ECC, with no difference in mortality though.

New Braile Inovare transcatheter aortic prosthesis: clinical results and follow-up.

AIMS: Transcatheter aortic valve implantation has emerged as an alternative to conventional aortic valve replacement in high-risk patients. Diverse prostheses are currently under investigation. The aim of this study was the clinical, safety and efficacy assessment of Braile Inovare Transcatheter Aortic Prosthesis usage. METHODS AND RESULTS: Ninety high-risk or inoperable patients underwent transcatheter aortic valve implantation. The mean logistic EuroSCORE was 39.3%. All patients presented calcified aortic stenosis. The procedures were performed under fluoroscopic and echocardiographic guidance. Prostheses were implanted through the transapical approach under rapid ventricular pacing. Echocardiographic and angiographic controls were included. Implantation was feasible in 87 cases. There was only one case of operative mortality, and 30-day mortality was 13.3%. The median transvalvular aortic gradient was reduced from 44.8±15.3 to 14.1±8.0 mmHg. Left ventricular function improved in the first seven postoperative days. Paravalvular aortic regurgitation was present in 29.7% of cases, mostly trace. One case presented a major vascular complication, and there were two cases of permanent pacemaker implantation. Two cases of major stroke occurred. CONCLUSIONS: Transcatheter aortic valve replacement using the Braile Inovare prosthesis is able to provide encouraging results with significant functional and structural cardiac improvement. It is mandatory to continue follow-up to measure the benefits of this device as well as to improve selection criteria of patients.

Long-Term and Sustained Therapeutic Results of a Specific Promonocyte Cell Formulation in Refractory Angina: ReACT(®) (Refractory Angina Cell Therapy) Clinical Update and Cost-Effective Analysis.

Mononuclear stem cells have been studied for their potential in myocardial ischemia. In our previous published article, ReACT(®) phase I/II clinical trial, our results suggest that a certain cell population, promonocytes, directly correlated with the perceived angiogenesis in refractory angina patients. This study is ReACT's clinical update, assessing long-term sustained efficacy. The ReACT phase IIA/B noncontrolled, open-label, clinical trial enrolled 14 patients with refractory angina and viable ischemic myocardium, without ventricular dysfunction, who were not suitable for myocardial revascularization. The procedure consisted of direct myocardial injection of a specific mononuclear cell formulation, with a certain percentage of promonocytes, in a single series of multiple injections (24-90; 0.2 ml each) into specific areas of the left ventricle. Primary endpoints were Canadian Cardiovascular Society Angina Classification (CCSAC) improvement at the 12-month follow-up and ischemic area reduction (scintigraphic analysis) at the 12-month follow-up, in correlation with ReACT's formulation. A recovery index (for patients with more than 1 year follow-up) was created to evaluate CCSAC over time, until April 2011. Almost all patients presented progressive improvement in CCSAC beginning 3 months (p=0.002) postprocedure, which was sustained at the 12-month follow-up (p=0.002), as well as objective myocardium ischemic area reduction at 6 months (decrease of 15%, p<0.024) and 12 months (decrease of 100%, p<0.004) The recovery index (n=10) showed that the patients were graded less than CCSAC 4 for 73.9 ± 24.2% over a median follow-up time of 46.8 months. After characterization, ReACT's promonocyte concentration suggested a positive correlation with CCSAC improvement (r=-0.575, p=0.082). Quality of life (SF-36 questionnaire) improved significantly in almost all domains. Cost-effectiveness analysis showed decrease in angina-related direct costs. Refractory angina patients presented a sustained long-term improvement in CCSAC and myocardium ischemic areas after the procedure. The long-term follow-up and strong improvement in quality of life reinforce effectiveness. Promonocytes may play a key role in myocardial neoangiogenesis. ReACT dramatically decreased direct costs.