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.

Thirty-day Outcomes of On-Pump and Off-Pump Coronary Artery Bypass Grafting: an Analysis of a Brazilian Sample by Propensity Score Matching

Abstract Introduction: Coronary artery bypass grafting (CABG) performed with and without cardiopulmonary bypass (CPB) support has been widely discussed in the literature. However, little is known about the outcomes of those techniques in Brazil. This study aims at exploring 30-day mortality and morbidity outcomes of on- and off-pump isolated CABG in a large sample from Southern Brazil. Methods: A single-center cohort with 1,767 patients undergoing isolated CABG (January 2013 - December 2018) was initially evaluated. Patients undergoing off-pump (N=397) and on-pump (N=1,370) CABG were identified. To obtain two completely homogeneous study groups, propensity score matching was used. The paired groups were compared by descriptive and univariate analyses. Then, logistic regression was used to verify the effects of on- and off-pump CABG on 30-day mortality. Results: None of the baseline characteristics showed significant difference between the groups (P>0.05). None of the analyzed morbidity outcomes showed any difference between the groups, including acute myocardial infarction (3.0% vs. 1.5%; P=0.192), stroke (2.4% vs. 4.2%; P=0.193), and major reoperation (0.6% vs. 0.3%; P=1.000), as well as the major adverse cardiovascular and cerebrovascular events composite outcome (6.3% vs. 7.5%; P=0.541). Mortality also did not differ (1.5% vs. 2.4%; P=0.401), and CPB support was not an independent predictor of risk for 30-day mortality (odds ratio: 2.052; 95% confidence interval: 0,609-6.913; P=0.246). Conclusion: After matching by propensity analyses, similar rates of on- and off-pump 30-day mortality and other major outcomes were observed. In addition, the use of CPB support was not an independent predictor of risk for the occurrence of 30-day mortality.

Development and application of a system based on artificial intelligence for transcatheter aortic prosthesis selection

Abstract Introduction: The interest in Expert systems has increased in the medical area. Some of them are employed even for diagnosis. With the variability of transcatheter prostheses, the most appropriate choice can be complex. This scenario reveals an enabling environment for the use of an Expert system. The goal of the study was to develop an Expert system based on artificial intelligence for supporting the transcatheter aortic prosthesis selection. Methods: The system was developed on Expert SINTA. The rules were created according to anatomical parameters indicated by the manufacturing company. Annular aortic diameter, aortic area, aortic perimeter, ascending aorta diameter and Valsalva sinus diameter were considered. After performing system accuracy tests, it was applied in a retrospective cohort of 22 patients with submitted to the CoreValve prosthesis implantation. Then, the system indications were compared to the real heart team decisions. Results: For 10 (45.4%) of the 22 patients there was no concordance between the Expert system and the heart team. In all cases with discordance, the software was right in the indication. Then, the patients were stratified in two groups (same indication vs. divergent indication). The baseline characteristics did not show any significant difference. Mortality, stroke, acute myocardial infarction, atrial fibrillation, atrioventricular block, aortic regurgitation and prosthesis leak did not present differences. Therefore, the maximum aortic gradient in the post-procedure period was higher in the Divergent Indication group (23.9 mmHg vs. 11.9 mmHg, P=0.03), and the mean aortic gradient showed a similar trend. Conclusion: The utilization of the Expert system was accurate, showing good potential in the support of medical decision. Patients with divergent indication presented high post-procedure aortic gradients and, even without clinical repercussion, these parameters, when elevated, can lead to early prosthesis dysfunction and the necessity of reoperation.

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 ...