ABSTRACT
OBJECTIVE: To assess actual data on the safety, effectiveness, and hemodynamic performance of Bovine Pericardium Organic Valvular Bioprosthesis (BVP). METHODS: The BIOPRO Trial is an observational, retrospective, non-comparative, non-randomized, and multicenter study. We collected data from 903 patients with symptomatic, moderate, or severe valve disease who underwent BVP implants in the timeframe from 2013 to 2020 at three Brazilian institutions. Death, valve-related adverse events (AEs), functional recovery, and hemodynamic performance were evaluated at the hospital, at discharge, and six months and one year later. Primary analysis compared late (> 30 days after implant) linearized rates of valve-related AEs, such as thromboembolism, valve thrombosis, major hemorrhage, major paravalvular leak, and endocarditis, following objective performance criteria (OPC). Analysis was performed to include at least 400 valve-years for each valve position (aortic and mitral) for complete comparisons to OPC. Kaplan-Meier survival and major adverse cardiovascular and cerebrovascular event analyses were also performed. RESULTS: This retrospective study analyzed follow-up data collected from 903 patients (834.2 late patient-years) who have undergone surgery for 455 isolated aortic valve replacement (50.4%), 382 isolated mitral valve replacement (42.3%), and 66 combined valve replacement or other intervention (7.3%). The linearized rates of valve-related AEs were < 2 × OPC. One-year survival rates were 95.1% and 92.7% for aortic and mitral valve replacement, respectively. This study demonstrated an improvement in the New York Heart Association classification from baseline and hemodynamic performance within an expected range. CONCLUSION: According to this analysis, BVP meets world standards for safety and clinical efficacy.
Subject(s)
Aortic Valve Stenosis , Bioprosthesis , Heart Valve Prosthesis Implantation , Heart Valve Prosthesis , Animals , Cattle , Humans , Aortic Valve/surgery , Aortic Valve Stenosis/surgery , Heart Valve Prosthesis Implantation/adverse effects , Hemodynamics , Pericardium/transplantation , Postoperative Complications/etiology , Prosthesis Design , Retrospective Studies , Treatment OutcomeABSTRACT
ABSTRACT Objective: To assess actual data on the safety, effectiveness, and hemodynamic performance of Bovine Pericardium Organic Valvular Bioprosthesis (BVP). Methods: The BIOPRO Trial is an observational, retrospective, non-comparative, non-randomized, and multicenter study. We collected data from 903 patients with symptomatic, moderate, or severe valve disease who underwent BVP implants in the timeframe from 2013 to 2020 at three Brazilian institutions. Death, valve-related adverse events (AEs), functional recovery, and hemodynamic performance were evaluated at the hospital, at discharge, and six months and one year later. Primary analysis compared late (> 30 days after implant) linearized rates of valve-related AEs, such as thromboembolism, valve thrombosis, major hemorrhage, major paravalvular leak, and endocarditis, following objective performance criteria (OPC). Analysis was performed to include at least 400 valve-years for each valve position (aortic and mitral) for complete comparisons to OPC. Kaplan-Meier survival and major adverse cardiovascular and cerebrovascular event analyses were also performed. Results: This retrospective study analyzed follow-up data collected from 903 patients (834.2 late patient-years) who have undergone surgery for 455 isolated aortic valve replacement (50.4%), 382 isolated mitral valve replacement (42.3%), and 66 combined valve replacement or other intervention (7.3%). The linearized rates of valve-related AEs were < 2 × OPC. One-year survival rates were 95.1% and 92.7% for aortic and mitral valve replacement, respectively. This study demonstrated an improvement in the New York Heart Association classification from baseline and hemodynamic performance within an expected range. Conclusion: According to this analysis, BVP meets world standards for safety and clinical efficacy.
ABSTRACT
Objectives: Emergent and late conversions form OFF-to-ON pump coronary artery bypass grafting (CABG) have been associated with worse outcomes, however, it remains unclear as to which risk factors are associated with conversion and how to prevent them. Methods: Among 4718 patients who randomly underwent off- or on-pump CABG, the incidence of off-pump to on-pump cross-over, or 'OFF-to-ON conversion', was 7.9% (186/2356). The primary outcome was a composite of death, stroke, myocardial infarction, or new renal failure requiring dialysis. We assessed the risk factors and outcomes of converted patients. Results: Emergent OFF-to-ON conversions, defined as conversions for hypotension or ischaemia, were required for 3.2% of patients ( n = 75), while most elective conversions were due to small or intramuscular coronaries ( n = 83). OFF-to-ON converted patients required increased surgery time, blood transfusions, intensive care unit stay, and presented a higher incidence at 1 year of the composite outcome compared with non-converted off-pump patients (all P < 0.01), especially if the conversion was emergent. Conversely, elective conversions outcomes were no different compared with non-converted off-pump patients ( P = 0.35). Independent predictors of emergent conversions included higher heart rate or chronic atrial fibrillation, urgent surgery, more grafts planned and surgeon experience with off-pump CABG. Conclusions: Emergent OFF-to-ON conversion is associated with worse outcomes compared with elective conversion or no conversion. In the presence of risk factors for emergent conversion, an early and elective conversion approach is a judicious strategy.
Subject(s)
Cardiopulmonary Bypass/adverse effects , Coronary Artery Bypass, Off-Pump/adverse effects , Aged , Coronary Artery Bypass/adverse effects , Coronary Artery Bypass/methods , Double-Blind Method , Female , Humans , Intraoperative Care/methods , Intraoperative Complications/therapy , Intraoperative Period , Kaplan-Meier Estimate , Male , Middle Aged , Risk Factors , Treatment OutcomeABSTRACT
OBJECTIVES: Emergent and late conversions form OFF-to-ON pump coronary artery bypass grafting (CABG) have been associated with worse outcomes, however, it remains unclear as to which risk factors are associated with conversion and how to prevent them. METHODS: Among 4718 patients who randomly underwent off- or on-pump CABG, the incidence of off-pump to on-pump cross-over, or 'OFF-to-ON conversion', was 7.9% (186/2356). The primary outcome was a composite of death, stroke, myocardial infarction, or new renal failure requiring dialysis. We assessed the risk factors and outcomes of converted patients. RESULTS: Emergent OFF-to-ON conversions, defined as conversions for hypotension or ischaemia, were required for 3.2% of patients ( n = 75), while most elective conversions were due to small or intramuscular coronaries ( n = 83). OFF-to-ON converted patients required increased surgery time, blood transfusions, intensive care unit stay, and presented a higher incidence at 1 year of the composite outcome compared with non-converted off-pump patients (all P < 0.01), especially if the conversion was emergent. Conversely, elective conversions outcomes were no different compared with non-converted off-pump patients ( P = 0.35). Independent predictors of emergent conversions included higher heart rate or chronic atrial fibrillation, urgent surgery, more grafts planned and surgeon experience with off-pump CABG...
Subject(s)
Extracorporeal Circulation , General Surgery , Intraoperative Care , Myocardial RevascularizationABSTRACT
O implante de valva aórtica transcateter (TAVI) é uma alternativa para pacientes com estenose aórtica de alto risco cirúrgico e para muitos daqueles considerados inoperáveis. Apesar de sua característica minimamente invasiva, podem ocorrer complicações relacionadas ao procedimento. Obstrução coronária durante o TAVI é uma complicação rara, com incidência inferior a 1%, mas potencialmente letal. Em nosso país, essa complicação foi encontrada em 0,72% dos procedimentos − 3 de 418 casos do Registro Brasileiro de Implante de Bioprótese Aórtica por Cateter − com mortalidade hospitalar de 100%. Apresentamos, neste relato de caso, medidas de prevenção e tratamento de oclusão coronária após o TAVI.
Transcatheter aortic valve implantation (TAVI) is an alternative for patients with aortic stenosis at high surgical risk and for many of those considered inoperable. Despite its minimally invasive features,complications related to the procedure may occur. Coronary obstruction during TAVI is a rare (incidence rate of less than 1%) but potentially lethal complication. In Brazil, this complication was found in 0.72% of procedures three of 418 cases from the Brazilian Transcatheter Aortic Valve Implantation Registry with an in-hospital mortality rate of 100%. This case report presents prevention and treatment measures forcoronary occlusion after TAVI.
Subject(s)
Humans , Female , Aged , Aortic Valve Stenosis/therapy , Heart Valve Prosthesis Implantation/methods , Coronary Occlusion/complications , Coronary Occlusion/therapy , Angioplasty/methods , Femoral Artery , Catheters , Echocardiography/methods , Risk Factors , Percutaneous Coronary Intervention/methods , Stents , Aortic Valve/surgeryABSTRACT
Objective: To compare in-hospital outcomes in aortic surgery in our cardiac surgery unit, before and after foundation of our Center for Aortic Surgery (CTA). Methods: Prospective cohort with non-concurrent control. Foundation of CTA required specialized training of surgical, anesthetic and intensive care unit teams, routine neurological monitoring, endovascular and hybrid facilities, training of the support personnel, improvement of the registry and adoption of specific protocols. We included 332 patients operated on between: January/2003 to December/2007 (before-CTA, n=157, 47.3%); and January/2008 to December/2010 (CTA, n=175, 52.7%). Baseline clinical and demographic data, operative variables, complications and in-hospital mortality were compared between both groups. Results: Mean age was 58±14 years, with 65% male. Group CTA was older, had higher rate of diabetes, lower rates of COPD and HF, more non-urgent surgeries, endovascular procedures, and aneurysms. In the univariate analysis, CTA had lower mortality (9.7 vs. 23.0%, P=0.008), which occurred consistently across different diseases and procedures. Other outcomes which were reduced in CTA included lower rates of reinterventions (5.7 vs 11%, P=0.046), major complications (20.6 vs. 33.1%, P=0.007), stroke (4.6 vs. 10.9%, P=0.045) and sepsis (1.7 vs. 9.6%, P=0.001), as compared to before-CTA. Multivariable analysis adjusted for potential counfounders revealed that CTA was independently associated with mortality reduction (OR=0.23, IC 95% 0.08 – 0.67, P=0.007). CTA independent mortality reduction was consistent in the multivariable analysis stratified by disease (aneurysm, OR=0.18, CI 95% 0.03 – 0.98, P=0.048; dissection, OR=0.31, CI 95% 0.09 – 0.99, P=0.049) and by procedure (hybrid, OR=0.07, CI 95% 0.007 – 0.72, P=0.026; Bentall, OR=0.18, CI 95% 0.038 – 0.904, P=0.037). Additional multivariable predictors of in-hospital mortality included creatinine ...
Objetivo: Comparar desfechos intrahospitalares em pacientes submetidos a cirurgia da aorta torácica e toracoabdominal, antes e após a constituição do Centro Especializado de Tratamento da Aorta (CTA). Métodos: Coorte prospectiva com controle não contemporâneo. A criação do CTA envolveu treinamento cirúrgico especializado, sala híbrida, monitorização neurológica, capacitação de pessoal de apoio, aperfeiçoamento dos registros e uso de protocolos específicos. Foram incluídos 332 pacientes operados em 2 períodos: janeiro/2003 a dezembro/2007 (pré-CTA, n=157, 47,3%); e janeiro/2008 a dezembro/2010 (CTA, n=175, 52,7%). As características demográficas, clínicas, dados cirúrgicos, complicações e mortalidade hospitalar foram comparados nos 2 grupos. Resultados: A idade média foi 58±14 anos, com 65% sexo masculino. O grupo CTA teve idade, prevalência de diabete (DM) e glicemia maiores; menor prevalência de doença pulmonar obstrutiva crônica e insuficiência cardíaca; maior proporção de aneurismas e cirurgias eletivas; e mais procedimentos endovasculares que o pré-CTA. Na análise univariada, o grupo CTA mostrou redução de mortalidade (9,7% x 23,0%, P=0,008), que foi consistente nos diferentes subgrupos estratificados por patologia e por procedimento. O grupo CTA teve também redução de reoperações (5,7% x 11%, P=0,046), complicações maiores (20,6% x 33,1%, P=0,007), acidente vascular cerebral (4,6% x 10,9%, P=0,045) e sepse (1,7% x 9,6%, P=0,001), comparado ao pré-CTA. Na análise multivariada, o CTA se associou de forma independente a redução de mortalidade hospitalar (OR=0,23, IC 95% 0,08 - 0,67, P=0,007). A redução de mortalidade do CTA também ocorreu na análise estratificada por patologia (cirurgias de aneurisma, OR=0,18, IC 95% 0,03 - 0,98, P=0,048; cirurgias de dissecção, OR=0,31, IC 95% 0,09 - 0,99, P=0,049) e por procedimento (híbridos, OR=0,07, IC 95% 0,007 - 0,72, P=0,026; Bentall, OR=0,18, IC 95% 0,038 – 0,904, P=0,037). Também foram ...
Subject(s)
Adult , Aged , Female , Humans , Male , Middle Aged , Aorta/surgery , Aortic Diseases/mortality , Aortic Diseases/surgery , Hospitals, Special/statistics & numerical data , Aortic Valve/surgery , Coronary Artery Bypass/methods , Coronary Artery Bypass/mortality , Epidemiologic Methods , Endovascular Procedures/methods , Hospital Mortality , Intensive Care Units , Length of Stay , Sex Factors , Treatment OutcomeABSTRACT
OBJECTIVE: To compare in-hospital outcomes in aortic surgery in our cardiac surgery unit, before and after foundation of our Center for Aortic Surgery (CTA). METHODS: Prospective cohort with non-concurrent control. Foundation of CTA required specialized training of surgical, anesthetic and intensive care unit teams, routine neurological monitoring, endovascular and hybrid facilities, training of the support personnel, improvement of the registry and adoption of specific protocols. We included 332 patients operated on between: January/2003 to December/2007 (before-CTA, n=157, 47.3%); and January/2008 to December/2010 (CTA, n=175, 52.7%). Baseline clinical and demographic data, operative variables, complications and in-hospital mortality were compared between both groups. RESULTS: Mean age was 58±14 years, with 65% male. Group CTA was older, had higher rate of diabetes, lower rates of COPD and HF, more non-urgent surgeries, endovascular procedures, and aneurysms. In the univariate analysis, CTA had lower mortality (9.7 vs. 23.0%, P=0.008), which occurred consistently across different diseases and procedures. Other outcomes which were reduced in CTA included lower rates of reinterventions (5.7 vs 11%, P=0.046), major complications (20.6 vs. 33.1%, P=0.007), stroke (4.6 vs. 10.9%, P=0.045) and sepsis (1.7 vs. 9.6%, P=0.001), as compared to before-CTA. Multivariable analysis adjusted for potential confounders revealed that CTA was independently associated with mortality reduction (OR=0.23, IC 95% 0.08 - 0.67, P=0.007). CTA independent mortality reduction was consistent in the multivariable analysis stratified by disease (aneurysm, OR=0.18, CI 95% 0.03 - 0.98, P=0.048; dissection, OR=0.31, CI 95% 0.09 - 0.99, P=0.049) and by procedure (hybrid, OR=0.07, CI 95% 0.007 - 0.72, P=0.026; Bentall, OR=0.18, CI 95% 0.038 - 0.904, P=0.037). Additional multivariable predictors of in-hospital mortality included creatinine (OR=1.7 [1.1-2.6], P=0.008), urgent surgery (OR=5.0 [1.5-16.7], P=0.008) and thoracoabdominal aneurysm (OR=24.6 [3.1-194.1], P=0.002). CONCLUSION: Thoracic aorta surgery in specialized center was associated with lower incidence of complications and all-cause mortality as compared to usual care.
Subject(s)
Aorta/surgery , Aortic Diseases/mortality , Aortic Diseases/surgery , Hospitals, Special/statistics & numerical data , Adult , Aged , Aortic Valve/surgery , Coronary Artery Bypass/methods , Coronary Artery Bypass/mortality , Endovascular Procedures/methods , Epidemiologic Methods , Female , Hospital Mortality , Humans , Intensive Care Units , Length of Stay , Male , Middle Aged , Sex Factors , Treatment OutcomeABSTRACT
OBJETIVO: Avaliar os resultados da cirurgia combinada (endarterectomia carotídea e cirurgia de revascularização do miocárdio) em pacientes com doença carotídea e coronária concomitante. MÉTODOS: Os autores revisam 49 trabalhos que descrevem vários aspectos sobre a cirurgia combinada em um total de 4.788 pacientes, analisando eventos precoces no período peri-operatório. RESULTADOS: As taxas globais de acidente vascular cerebral (AVC), infarto agudo do miocárdio (IAM) e mortalidade foram, respectivamente, de 4,3 por cento; 2,2 por cento; e 4,2 por cento. Para os trabalhos mais recentes (entre 1990-2000), a ocorrência de AVC foi significativamente inferior àquela obtida por trabalhos publicados anteriormente (entre 1972-1989) (4,1 por cento x 10,2 por cento; p < 0,05). Neste mesmo levantamento, os índices de AVC pós-operatórios foram maiores nos artigos que continham uma amostra pequena (n < 50) que naqueles trabalhos com uma população maior (n > 100) (7,2 por cento x 3,9 por cento; p < 0,05), denotando o impacto da experiência dos cirurgiões sobre os resultados pós-operatórios. CONCLUSÃO: Em suma, acreditamos que a cirurgia combinada é um procedimento seguro e eficaz quando realizado por cirurgiões experientes e qualificados.
Subject(s)
Humans , Coronary Artery Disease/surgery , Coronary Artery Bypass , Carotid Artery Diseases/surgery , Endarterectomy, Carotid , Stroke/etiology , Coronary Artery Disease/mortality , Postoperative Complications/mortality , Carotid Artery Diseases/mortality , Endarterectomy, Carotid/mortality , Myocardial Infarction/etiology , Coronary Artery Bypass/mortality , Risk Factors , Time Factors , Treatment OutcomeABSTRACT
OBJECTIVE: To evaluate the results of combined surgery (carotid endarterectomy and coronary artery bypass grafting) in patients with concomitant carotid and coronary artery disease. METHODS: The authors reviewed 49 different reports describing several aspects of the combined surgery in 4788 patients to analyze early events in the perioperative period. RESULTS: Overall stroke, acute myocardial infarction (AMI), and mortality rates were 4.3%, 2.2%, and 4.2%, respectively. Most recent papers (1990 to 2000) show significant lower incidence of strokes compared to those published earlier (1972 to 1989) (4.1% x 10.2%; p < 0.05). In this same survey, the incidence of postoperative stroke was higher in the series with a small sample (n < 50) than in those with a larger population (n > 100) (7.2% x 3.9%; p < 0.05), denoting the impact of surgeons' experience on postoperative results. CONCLUSION: In sum, we believe that combined carotid endarterectomy and coronary artery bypass grafting is a safe and effective procedure when performed by experienced and qualified surgeons.
Subject(s)
Carotid Artery Diseases/surgery , Coronary Artery Bypass , Coronary Artery Disease/surgery , Endarterectomy, Carotid , Carotid Artery Diseases/mortality , Coronary Artery Bypass/mortality , Coronary Artery Disease/mortality , Endarterectomy, Carotid/mortality , Humans , Myocardial Infarction/etiology , Postoperative Complications/mortality , Risk Factors , Stroke/etiology , Time Factors , Treatment OutcomeSubject(s)
Coronary Disease/surgery , Myocardial Revascularization/standards , Anesthesia/standards , Extracorporeal Circulation/standards , Humans , Male , Minimally Invasive Surgical Procedures/standards , Multicenter Studies as Topic , Myocardial Infarction/complications , Myocardial Infarction/surgery , Postoperative Care , Postoperative Complications , Preoperative CareSubject(s)
Humans , Male , Coronary Disease/surgery , Myocardial Revascularization/standards , Anesthesia , Extracorporeal Circulation/standards , Multicenter Studies as Topic , Myocardial Infarction/complications , Myocardial Infarction/surgery , Postoperative Care , Postoperative Complications , Preoperative Care , Minimally Invasive Surgical Procedures/standardsABSTRACT
OBJETIVO: Analisar o impacto das contra-indicações para transplante cardíaco na mortalidade e no tempo de sobrevida dos pacientes submetidos a ventriculectomia parcial esquerda. MÉTODO: Ensaio clínico näo controlado, prospectivo, de uma coorte de 43 pacientes com contra-indicaçäo para transplante, submetidos a ventriculectomia. Foram analisadas as seguintes contra-indicações: psicológicas, socioculturais, idade superior a 65 anos, hiperresistência arteriolar pulmonar e hipertensäo arterial pulmonar e recusa do paciente ao transplante. A análise estatística incluiu testes do Qui-quadrado, o método atuarial de Kaplan-Meier, o teste do"log-rank", a regressäo de Cox, os intervalos de confiança de 95 por cento e a probabilidade p, considerada significativa quando inferior a 0,05. RESULTADOS: As contra-indicações para transplante que resultaram em maior mortalidade após a ventriculectomia foram as socioculturais (p = 0,037), psicológicas (p = 0,037) e a aceitaçäo do transplante (p = 0,017). Tiveram impacto negativo no tempo de sobrevida pós-operatório as contra-indicações psicológicas (p = 0,0466), a idade superior a 65 anos (p = 0,0397) e a aceitaçäo do transplante (p = 0,0306). A presença de hiperresistência arteriolar pulmonar e/ou de hipertensäo arterial pulmonar näo interferiu na mortalidade e no tempo de sobrevida após a ventriculectomia. CONCLUSAO: Algumas contra-indicações para transplante tiveram impacto prognóstico desfavorável na mortalidade e no tempo de sobrevida após a ventriculectomia parcial esquerda, a qual näo se revelou tratamento alternativo efetivo para este grupo de pacientes.
Subject(s)
Humans , Aged , Cardiomyopathy, Dilated , Heart Ventricles , Heart Failure , Heart Transplantation , Cohort Studies , Follow-Up StudiesABSTRACT
Os autores revisam as patologias da aorta, delineando a etiologia, diagnóstico, tratamento e mostrando sua experiência nos aneurismas e dissecçöes da aorta torácica
