Safety, Effectiveness, and Hemodynamic Performance of the Bovine Pericardium Organic Valvular Bioprosthesis.

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.

Safety, Effectiveness, and Hemodynamic Performance of the Bovine Pericardium Organic Valvular Bioprosthesis

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.

Conversion after off-pump coronary artery bypass grafting: the CORONARY trial experience.

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.

Conversion after off-pump coronary artery bypass grafting: the CORONARY trial experience

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...

Oclusão coronariana após TAVI: relato de estratégia de segurança / Coronary occlusion after TAVI: safety strategy report

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.

Aortic Center: specialized care improves outcomes and decreases mortality / Centro de Tratamento da Aorta: a especialização reduz complicações e mortalidade

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 ...

Aortic Center: specialized care improves outcomes and decreases mortality.

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.

Procedimento combinado entre operação de revascularização do miocárdio e endarterectomia de carótida: análise dos resultados / Combined carotid endarterectomy and coronary artery bypass grafting: analysis of the results

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.

[Combined carotid endarterectomy and coronary artery bypass grafting. Analysis of the results]. / Procedimento combinado entre operação de revascularização do miocárdio e endarterectomia de carótida. Análise dos resultados.

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.

Mortality after partial left ventriculectomy in relation to contraindications for heart transplantation

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.

Patologias da aorta: como chegamos ao final do século / Diseases of the Aorta

Os autores revisam as patologias da aorta, delineando a etiologia, diagnóstico, tratamento e mostrando sua experiência nos aneurismas e dissecçöes da aorta torácica