Computer-Assisted Transcatheter Mitral Valve Implantation for Valve-in-Valve Procedures.

Transcatheter mitral valve-in-valve is an alternative to high-risk reoperation on a failing bioprosthesis. It entails specific challenges such as left ventricular outflow tract obstruction. We propose a patient-specific augmented imaging based on preoperative planning to assist the procedure. Valve-in-valve simulation was performed to represent the optimal level of implantation and the neo-left ventricular outflow tract. These data were combined with intraoperative images through a real-time 3D/2D registration tool. All data were collected retrospectively on one case (pre and per-procedure imaging). We present for the first time an intraoperative guidance tool in transcatheter mitral valve-in-valve procedure.

Case Report: Transcatheter aortic valve implantation using balloon-expandable bioprosthesis in patients with severe pure aortic regurgitation on noncalcified native valves: a series of cases.

Background: For individuals with pure aortic regurgitation (AR), transcatheter aortic valve implantation (TAVI) is cautiously recommended only for those with a high or prohibitive surgical risk. We aimed to describe the results of a case series of transcatheter implantation of a balloon-expandable aortic valve bioprosthesis (BEV) for the treatment of noncalcified native valve AR. Methods: From February 2022-November 2022, we performed TAVI in patients with severe pure AR. Cases were indicated on the basis of symptoms, high/prohibitive surgical risk, or patient refusal of conventional treatment. Results: Five patients underwent successful TAVI. The mean age was 81.9 ± 6.6 years, 3 (60%) female and 5 (100%) in NYHA class III or IV. The baseline echocardiogram showed an ejection fraction of 49.0 ± 10.6% and left ventricular end-systolic diameter 28.5 ± 4.7 mm/m². The average area of the aortic annulus was 529.1 ± 47.0mm² and the area oversizing index was 17.6 ± 1.2%. In the 30-day follow-up, there were no cases of prosthesis embolization, annulus rupture, stroke, acute myocardial infarction, acute renal failure, hemorrhagic complication or death. One patient required a permanent pacemaker and another had a minor vascular complication. The clinical follow-up were 19.8 months (16.7-21.8). During this period, all patients remained alive and in NYHA class I or II. One of the patients developed a moderate paravalvular leak. Conclusion: TAVI with a BEV proved to be safe and effective in this small case series of patients with noncalcified native valve AR in a follow-up longer than 1 year.

Reparação da parede abdominal com membranas acelulares de pericárdio bovino - Parte I - Achados clínicos e radiológicos / Abdominal wall repair with acellular bovine pericardial membranes - Part I - Clinical and radiological findings

Introdução: Reduzindo os índices de recidiva de forma impactante, o emprego de biomateriais como "telas de reforço" na reparação de diferentes defeitos da parede abdominal tornou-se rotina quase obrigatória para o sucesso dessas reparações. A partir da década de 1990 houve a introdução de matrizes biológicas acelulares, iniciando-se assim uma nova era na reparação dos defeitos da parede abdominal. O objetivo é avaliar a funcionalidade do pericárdio bovino acelularizado em reparações da parede abdominal. Método: Trinta pacientes foram submetidos a reparação de defeitos da parede abdominal, com biopróteses acelulares de pericárdio bovino, perfazendo um total de 40 implantes anatomicamente individualizados. O seguimento médio foi de 31 meses, sendo os pacientes avaliados clinicamente e radiologicamente. Em três casos foram feitas biópsias das áreas implantadas permitindo análise histológica do material. Resultados: Não se observou recidiva das herniações em nenhum dos casos, tanto clinica como radiologicamente. Também não houve registro de hematomas, infecções ou qualquer fenômeno de natureza reacional local ou sistêmica. Radiologicamente, não foi possível visualizar as matrizes no local de implantação em qualquer dos períodos de pós-operatório analisados. Conclusão: As matrizes mostraram similaridade às demais membranas biológicas descritas na literatura internacional. Representando uma importante atualização e evolução conceitual, as membranas acelulares de pericárdio bovino podem ser incorporadas ao arsenal terapêutico nas reparações de parede abdominal.

Introduction: Reducing recurrence rates significantly, the use of biomaterials as "reinforcement meshes" in the repair of different abdominal wall defects has become an almost mandatory routine for the success of these repairs. From the 1990s onwards, acellular biological matrices were introduced, thus beginning a new era in the repair of abdominal wall defects. The objective is to evaluate the functionality of the acellularized bovine pericardium in abdominal wall repairs. Method: Thirty patients underwent repair of abdominal wall defects using acellular bovine pericardium bioprostheses, making a total of 40 anatomically individualized implants. The average follow-up was 31 months, with patients being evaluated clinically and radiologically. In three cases, biopsies were taken from the implanted areas, allowing histological analysis of the material. Results: No recurrence of herniations was observed in any of the cases, both clinically and radiologically. There were also no records of bruises, infections or any phenomenon of a local or systemic reaction nature. Radiologically, it was not possible to visualize the matrices at the implantation site in any of the postoperative periods analyzed. Conclusion: The matrices showed similarity to other biological membranes described in the international literature. Representing an important update and conceptual evolution, acellular bovine pericardial membranes can be incorporated into the therapeutic arsenal in abdominal wall repairs.

Reparação da parede abdominal com membranas acelulares de pericárdio bovino - Parte II - Análises histológicas e morfométricas / Repair of the abdominal wall with acellular bovine pericardial membranes - Part II - Histological and morphometric analyses

Introdução: Análise histológica é a principal ferramenta de avaliação de biopróteses acelulares, em sua maioria em caráter experimental. O objetivo é analisar histologicamente a matriz acelular de pericárdio bovino em reparações de parede abdominal implantada em humanos. Método: De uma série de 30 reparações com a membrana, 3 pacientes foram submetidas a revisão cirúrgica não relacionada aos implantes, aos 13, 22 e 23 meses de pós-operatório, obtendo-se biópsias das áreas previamente implantadas. Além da avaliação dos aspectos básicos de biocompatibilidade e neoformação tecidual, as lâminas foram digitalizadas e submetidas a análise computadorizada com o software ImageJ para quantificação da cinética de degradação das membranas, associada à análise da dimensão fractal das amostras. Os valores obtidos para porcentagens de membrana residual tiveram suas médias comparadas por análise de variância (ANOVA) e pelo teste T de Student não pareado, também utilizado para os valores da quantificação da dimensão fractal. Resultados: Foi demonstrada a biocompatibilidade do material, com neoformação tecidual, deposição de colágeno e tecido celularizado de aspecto normal, sem reações locais importantes. Fragmentos residuais da membrana foram quantificados em 40%±7% aos 13 meses, em 20%±6% aos 22 meses e em 17%±6% aos 23 meses de pós-operatório, com a análise da dimensão fractal indicando uma progressiva degradação dos implantes, com significância estatística entre 13 meses e as amostras tardias. Conclusão: Os resultados atestaram a funcionalidade do pericárdio bovino acelular sob diferentes níveis de estresse mecânico nas reparações da parede abdominal em humanos.

Introduction: Histological analysis is the main tool for evaluating acellular bioprostheses, mostly on an experimental basis. The objective is to histologically analyze the acellular matrix of bovine pericardium in abdominal wall repairs implanted in humans. Method: From a series of 30 repairs with the membrane, 3 patients underwent surgical revision unrelated to the implants at 13, 22, and 23 months postoperatively, obtaining biopsies of the previously implanted areas. In addition to evaluating the basic aspects of biocompatibility and tissue neoformation, the slides were digitalized and subjected to computerized analysis with the ImageJ software to quantify the kinetics of membrane degradation associated with the analysis of the fractal dimension of the samples. The values obtained for percentages of residual membrane had their means compared by analysis of variance (ANOVA) and the unpaired Student's T test, also used for the fractal dimension quantification values. Results: The biocompatibility of the material was demonstrated, with tissue neoformation, collagen deposition, and cellularized tissue with a normal appearance without important local reactions. Residual fragments of the membrane were quantified at 40%±7% at 13 months, at 20%±6% at 22 months, and at 17%±6% at 23 months postoperatively, with the analysis of the fractal dimension indicating a progressive degradation of implants, with statistical significance between 13 months and late samples. Conclusion: The results confirmed the functionality of the acellular bovine pericardium under different levels of mechanical stress in abdominal wall repairs in humans.

Endothelial Microparticles: Markers of Inflammatory Response After Sutureless Valve Implantation

ABSTRACT Introduction: Systemic inflammatory response syndrome (SIRS) is related to increased circulating endothelial microparticles (EMP). Objective: The aim of this study was to compare the plasma concentration of EMP between patients undergoing aortic valve replacement with conventional bioprosthesis implantation and Perceval™ S (LivaNova) and to evaluate its impact on the inflammatory response in the short-term follow-up. Methods: This is a randomized clinical trial with 24 patients submitted to isolated aortic valve replacement divided into two groups: Perceval™ S (Group P) and conventional bioprostheses (Group C). Incidence of severe SIRS (three or more criteria) in the first 48 hours postoperatively, EMP release profile, interleukins (IL) 6 and 8, C-reactive protein, and procalcitonin were analyzed preand postoperatively at 24 hours and three months. Results: There were 24 patients (12 in each group), mean age was 69.92±5.17 years, 83.33% were female, the incidence of severe SIRS was 66.7% and 50% in groups C and P, respectively (P=0.68), and EMP showed a significant increase in the 24-hour postoperative period (P≤0.001) and subsequent decrease in the three-month postoperative period (P≤0.001), returning to baseline levels. For IL-6 and IL-8, there was a greater increase in group C at 24 hours postoperatively (P=.0.02 and P<0.001). Conclusion: The incidence of severe SIRS was similar in both groups, with significantly higher levels of IL-6 and IL-8, at the 24-hour postoperative period, in group C, however with higher levels of EMP in group P, and subsequent return to baseline levels at the three-month postoperative period in both groups.

Prognostic Impact of Residual Moderate Mitral Regurgitation Following Valve-in-Valve Transcatheter Aortic Valve Implantation

ABSTRACT Introduction: The impact of mitral regurgitation (MR) on valve-in-valve transcatheter aortic valve implantation (VIV-TAVI) in patients with failed bioprostheses remains unclear. The purpose of this study was to assess the prognostic impact of residual moderate MR following VIV-TAVI. Methods: We retrospectively analyzed 127 patients who underwent VIV-TAVI between March 2010 and November 2021. At least moderate MR was observed in 51.2% of patients before the procedure, and MR improved in 42.1% of all patients. Patients with postoperative severe MR, previous mitral valve intervention, and patients who died before postoperative echocardiography were excluded from further analyses. The remaining 114 subjects were divided into two groups according to the degree of postprocedural MR: none-mild MR (73.7%) or moderate MR (26.3%). Propensity score matching yielded 23 pairs for final comparison. Results: No significant differences were found between groups before and after matching in early results. In the matched cohort, survival probabilities at one, three, and five years were 95.7% vs. 87.0%, 85.0% vs. 64.5%, and 85.0% vs. 29.0% in the none-mild MR group vs. moderate MR-group, respectively (log-rank P=0.035). Among survivors, patients with moderate MR had worse functional status according to New York Heart Association (NYHA) class at follow-up (P=0.006). Conclusion: MR is common in patients with failed aortic bioprostheses, and improvement in MR-status was observed in over 40% of patients following VIV-TAVI. Residual moderate MR after VIV-TAVI is not associated with worse early outcomes, however, it was associated with increased mortality at five years of follow-up and worse NYHA class among survivors.

Computer-Assisted Transcatheter Mitral Valve Implantation for Valve-in-Valve Procedures

ABSTRACT Transcatheter mitral valve-in-valve is an alternative to high-risk reoperation on a failing bioprosthesis. It entails specific challenges such as left ventricular outflow tract obstruction. We propose a patient-specific augmented imaging based on preoperative planning to assist the procedure. Valve-in-valve simulation was performed to represent the optimal level of implantation and the neo-left ventricular outflow tract. These data were combined with intraoperative images through a real-time 3D/2D registration tool. All data were collected retrospectively on one case (pre and per-procedure imaging). We present for the first time an intraoperative guidance tool in transcatheter mitral valve-in-valve procedure.

Anticoagulación precoz con warfarina en pacientes sometidos a sustitución valvular aórtica por bioprótesis: ensayo prospectivo randomizado: análisis interino / Early anticoagulation with warfarin in patients undergoing bioprosthetic aortic valve replacement: randomized prospective trial: interim analysis / Anticoagulação precoce com varfarina em pacientes submetidos à troca valvar aórtica por bioprótese: ensaio prospectivo randomizado: análise provisória

Introducción: aunque las bioprótesis son menos trombogénicas que las válvulas mecánicas; la trombosis de estas es una entidad cada vez más reconocida como causa de disfunción protésica potencialmente reversible. No está definido el beneficio de la anticoagulación rutinaria versus antiagregación plaquetaria luego de la sustitución valvular aórtica (SVA) por bioprótesis. La anticoagulación precoz podría asociarse a menores gradientes transprotésicos con similar riesgo de complicaciones. Objetivos: el objetivo primario es determinar si existe una diferencia significativa en la variación del gradiente transprotésico medio al año de la SVA entre las dos estrategias de tratamiento antitrombótico. Los objetivos secundarios son la comparación de la variación del gradiente máximo y del área valvular aórtica, y parámetros clínicos que incluyen la Clase Funcional de la New York Heart Association, las tasas de sangrado mayor y menor y la incidencia de eventos embólicos. Este trabajo representa el análisis interino a 3 meses de un proyecto a más largo plazo, y se propone mostrar los resultados preliminares de los puntos finales previamente definidos. Métodos: se presenta el análisis interino de un ensayo randomizado multicéntrico. Todos los pacientes sometidos a SVA por bioprótesis porcinas fueron sucesivamente reclutados en dos centros de cirugía cardíaca desde el 01/01/2019 hasta el 01/09/2019. El grupo anticoagulación recibió warfarina durante los primeros 3 meses y ambos recibieron aspirina a largo plazo. Se realizaron instancias de seguimiento clínicas y ecocardiográficas antes del alta, a los 3 meses y al año. Resultados: se reclutaron 107 pacientes; 46% de ellos fueron randomizados al grupo anticoagulación y 54% al grupo control. No existieron diferencias en las características basales. Tampoco existieron diferencias significativas entre ambos grupos en la variación entre el alta y los 3 meses del área valvular protésica, coeficiente de obstrucción, gradiente máximo ni gradiente medio ni en la clase funcional. En cuanto a las complicaciones, no existieron eventos embólicos y los sangrados no difirieron significativamente entre ambos grupos. Conclusiones: la anticoagulación no modificó la variación de los gradientes transprotésicos a los 3 meses. Asimismo, no produjo mayor incidencia de efectos adversos. Todavía no está dilucidado si la anticoagulación precoz con warfarina luego de la SVA tiene impacto en los resultados a largo plazo.

Introduction: although bioprostheses are less thrombogenic than mechanical valves, bioprosthesis valve thrombosis is an increasingly recognized entity that can cause potentially reversible prosthetic valve dysfunction. There is a lack of consensus whether to use anticoagulation after aortic valve replacement (AVR) or antiplatelet therapy. Our hypothesis is that early anticoagulation is associated with lower transprosthetic gradients with similar risk of complications. Objective: primary objective is to determine if there is a significant difference in the variation of the mean transprosthetic gradient (ΔGm) one year after SVA between the two antithrombotic treatment strategies. Secondary objectives are the comparison of the variation of maximum gradient and aortic valve area, and clinical parameters including NYHA functional class, major and minor bleeding rates, and the incidence of embolic events. This work represents the 3-month interim analysis of a longer-term project, and is intended to show the preliminary results of the previously defined end points. Methods: this is an interim analysis of a multicenter randomized trial. All patients who underwent AVR by porcine bioprostheses were successively recruited in two cardiac surgery centers in Montevideo between 01/01/2019 and 01/09/2019. The anticoagulation group received warfarin for 3 months. Both groups received aspirin. Clinical and echocardiographic follow-up consultations were performed before discharge, at 3 months, and at 1 year. Results: 107 patients were recruited, 46% were randomized to the anticoagulation group and 54% to the control group. There were no differences in baseline characteristics. There were no significant differences between the two groups in the variation between discharge and 3 months of effective orifice area, doppler velocity index, peak gradient and mean gradient. There were also no differences between both groups in functional class. Regarding complications, there were no embolic events and bleeding did not differ significantly. Conclusions: in this study, anticoagulation did not modify the variation of transprosthetic gradients at 3 months. Likewise, it did not produce a higher incidence of adverse effects. It remains unclear whether early anticoagulation with warfarin after AVR has an impact on long-term outcomes.

Introdução: embora as biopróteses sejam menos trombogênicas que as mecânicas, a trombose de biopróteses é uma entidade cada vez mais reconhecida como causa de disfunção protética potencialmente reversível. A anticoagulação de rotina após a substituição da valva aórtica por bioprótese (SVA) não está definida. Nossa hipótese é que a anticoagulação precoce está associada a menores gradientes transprotéticos com risco semelhante de complicações. Objetivo: o objetivo principal é determinar se há uma diferença significativa na variação do gradiente transprotético médio (ΔGm) um ano após SVA entre as duas estratégias de tratamento antitrombótico. Os objetivos secundários são a comparação da variação do gradiente máximo e da área valvar aórtica e parâmetros clínicos, incluindo NYHA CF, taxas de sangramento maior e menor e incidência de eventos embólicos. Este trabalho representa a análise intercalar de 3 meses de um projeto de longo prazo, e pretende mostrar os resultados preliminares dos pontos finais previamente definidos. Métodos: apresenta-se a análise interina de um estudo multicêntrico randomizado. Todos os pacientes submetidos a SVA por biopróteses suínas foram sucessivamente recrutados em dois centros de cirurgia cardíaca em Montevidéu, durante um período de recrutamento de 1/1/2019 a 1/9/2019. O grupo de anticoagulação recebeu warfarina por 3 meses. Ambos os grupos receberam aspirina. Foram realizadas consultas médicas clínicas e ecocardiográficas antes da alta, aos 3 meses e ao 1 ano. Resultados: foram recrutados 107 pacientes, 46% foram randomizados para o grupo anticoagulação e 54% para o grupo controle. Não houve diferenças nas características basais. Não houve diferenças significativas entre os dois grupos da variação entre alta e 3 meses na área valvar, coeficiente de obstrução, gradiente máximo ou gradiente médio. Também não houve diferenças entre os dois grupos na classe funcional. Em relação às complicações, não houve eventos embólicos e sangramentos não diferiram significativamente. Conclusões: neste estudo, a anticoagulação não modificou a variação dos gradientes transprotéticos aos 3 meses. Da mesma forma, não produziu maior incidência de efeitos adversos. Ainda não está claro se a anticoagulação precoce com varfarina após SVA tem impacto nos resultados a longo prazo.

Prognostic Impact of Residual Moderate Mitral Regurgitation Following Valve-in-Valve Transcatheter Aortic Valve Implantation.

INTRODUCTION: The impact of mitral regurgitation (MR) on valve-in-valve transcatheter aortic valve implantation (VIV-TAVI) in patients with failed bioprostheses remains unclear. The purpose of this study was to assess the prognostic impact of residual moderate MR following VIV-TAVI. METHODS: We retrospectively analyzed 127 patients who underwent VIV-TAVI between March 2010 and November 2021. At least moderate MR was observed in 51.2% of patients before the procedure, and MR improved in 42.1% of all patients. Patients with postoperative severe MR, previous mitral valve intervention, and patients who died before postoperative echocardiography were excluded from further analyses. The remaining 114 subjects were divided into two groups according to the degree of postprocedural MR: none-mild MR (73.7%) or moderate MR (26.3%). Propensity score matching yielded 23 pairs for final comparison. RESULTS: No significant differences were found between groups before and after matching in early results. In the matched cohort, survival probabilities at one, three, and five years were 95.7% vs. 87.0%, 85.0% vs. 64.5%, and 85.0% vs. 29.0% in the none-mild MR group vs. moderate MR-group, respectively (log-rank P=0.035). Among survivors, patients with moderate MR had worse functional status according to New York Heart Association (NYHA) class at follow-up (P=0.006). CONCLUSION: MR is common in patients with failed aortic bioprostheses, and improvement in MR-status was observed in over 40% of patients following VIV-TAVI. Residual moderate MR after VIV-TAVI is not associated with worse early outcomes, however, it was associated with increased mortality at five years of follow-up and worse NYHA class among survivors.

Endothelial Microparticles: Markers of Inflammatory Response After Sutureless Valve Implantation.

INTRODUCTION: Systemic inflammatory response syndrome (SIRS) is related to increased circulating endothelial microparticles (EMP). OBJECTIVE: The aim of this study was to compare the plasma concentration of EMP between patients undergoing aortic valve replacement with conventional bioprosthesis implantation and Perceval™ S (LivaNova) and to evaluate its impact on the inflammatory response in the short-term follow-up. METHODS: This is a randomized clinical trial with 24 patients submitted to isolated aortic valve replacement divided into two groups: Perceval™ S (Group P) and conventional bioprostheses (Group C). Incidence of severe SIRS (three or more criteria) in the first 48 hours postoperatively, EMP release profile, interleukins (IL) 6 and 8, C-reactive protein, and procalcitonin were analyzed preand postoperatively at 24 hours and three months. RESULTS: There were 24 patients (12 in each group), mean age was 69.92±5.17 years, 83.33% were female, the incidence of severe SIRS was 66.7% and 50% in groups C and P, respectively (P=0.68), and EMP showed a significant increase in the 24-hour postoperative period (P≤0.001) and subsequent decrease in the three-month postoperative period (P≤0.001), returning to baseline levels. For IL-6 and IL-8, there was a greater increase in group C at 24 hours postoperatively (P=.0.02 and P<0.001). CONCLUSION: The incidence of severe SIRS was similar in both groups, with significantly higher levels of IL-6 and IL-8, at the 24-hour postoperative period, in group C, however with higher levels of EMP in group P, and subsequent return to baseline levels at the three-month postoperative period in both groups.

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.

A Surgical Technique to Preserve the Subvalvular Apparatus in Patients Undergoing Mitral Valve Replacement for Severe Ischemic Regurgitation

ABSTRACT Severe functional mitral valve regurgitation should be treated in patients undergoing myocardial revascularization. When replacement is considered the best therapeutic option, preservation of the mitral subvalvular apparatus is crucial, especially in the emergency setting, because of its primary role in preserving geometry and function of left and right ventricles. Here we present a simple and quick technique, where subvalvular apparatus is preserved in toto in patients undergoing mitral valve replacement with a bioprosthesis.

Valve in valve en posición tricuspídea: reconociendo opciones de manejo para la válvula «olvidada¼ / Valve in valve in tricuspid position: recognizing management options for the "forgotten" valve

Resumen Presentamos el caso de una paciente con bioprótesis tricuspídea disfuncionante a quien se le realizó un implante valve in valve con una prótesis transcatéter SAPIEN XT, demostrando que esta técnica es una alternativa terapéutica válida frente a la reintervención de la válvula tricúspide.

Abstract We present the case of a patient who was implanted with a transcatheter prosthesis on a dysfunctional bioprosthesis, demonstrating that it is a valid therapeutic alternative to reoperation in those patients with high surgical risk.

High Residual Gradient Following a Self-Expandable Transcatheter Aortic Valve-in-Valve Implantation — Risk Factor Analysis, Outcomes, and Survival

Abstract Introduction: Transcatheter aortic valve-in-valve implantation (TAVI-ViV) can be associated with unfavorable hemodynamic outcomes. This study aimed to estimate the prevalence, identify the risk factors, and evaluate the outcomes and survival of patients with high residual gradients after TAVI-ViV. Methods: A total of 85 patients were included in the study. The cohort was divided into group A, with postprocedural mean pressure gradient (PG) ≥ 20 mmHg, and group B, with mean PG < 20 mmHg. Results: Postprocedural PG ≥ 20 mmHg was observed in 24.7% of the patients. In a univariate analysis, preoperative gradient, pre-existing patient-prosthesis mismatch (PPM), deep valve implantation, small degenerated valves, and an older generation of transcatheter aortic valves were found to be risk factors for high residual gradient. Multivariate analysis showed that preexisting maxPG > 60 mmHg, implantation level of 4 mm below neo-annulus, and degenerated valve size ≤ 23 mm were independent predictors of high residual gradient. There were no differences in early morbidity (myocardial infarction, pacemaker implantation, stroke, acute renal insufficiency) between groups. Kaplan-Meier estimated that the survival rate was comparable at one and five years regardless of postoperative gradient. Survivors with high residual mean gradient were significantly affected by a high New York Heart Association (NYHA) class. Conclusion: High residual transvalvular gradient after TAVI-ViV is not rare, but it does not significantly affect mortality. High residual mean gradient has a negative impact on NYHA functional class improvement after the procedure. High preoperative gradient, implantation level, and small failed bioprosthesis may predispose to increased residual gradient.

A Surgical Technique to Preserve the Subvalvular Apparatus in Patients Undergoing Mitral Valve Replacement for Severe Ischemic Regurgitation.

Severe functional mitral valve regurgitation should be treated in patients undergoing myocardial revascularization. When replacement is considered the best therapeutic option, preservation of the mitral subvalvular apparatus is crucial, especially in the emergency setting, because of its primary role in preserving geometry and function of left and right ventricles. Here we present a simple and quick technique, where subvalvular apparatus is preserved in toto in patients undergoing mitral valve replacement with a bioprosthesis.

Comparison of Postoperative Outcomes of Sutureless versus Stented Bioprosthetic Aortic Valve Replacement

Abstract Objective: Sutureless aortic valve replacement (Su-AVR) offers an alternative to supra-annular stented biological aortic prostheses. This single-center study aimed to compare early outcomes after aortic valve replacement with sutureless and conventional stented bioprostheses. Methods: In this retrospective study, we analyzed 52 patients who underwent aortic valve replacement with sutureless and stented bioprostheses between January 2013 and October 2017. Sorin Perceval S sutureless valves were implanted in group 1 and Sorin Mitroflow stented bioprosthetic valves were used in group 2. Postoperative outcomes, including demographics, cardiopulmonary bypass (CPB) times, cross-clamp times, morbidity and mortality, as well as echocardiography in the first month, were compared. Results: Mortality occurred in 1 (3.6%) patient in group 1, and in 2 (8.3%) patients in group 2 (P=0.186). Group 1 had significantly shorter CPB (61.6±26.1 min vs. 106.3±32.7 min, P=0.001) and cross-clamp (30.9±13.6 min vs. 73.3±17.3 min, P=0.001) times. The length of stay in the intensive care unit (1.9±1.3 days vs. 2.4±4.9 days, P=0.598) and hospital stay (7.6±2.7 days vs. 7.3±2.6 days, P=0.66) were similar. Postoperatively, there was no statistically significant difference between the two groups in echocardiography results, and morbidities. The mean aortic valve gradient was 13.5±5.8 mmHg in group 1 and 14.5±8.0 mmHg in group 2 (P=0.634). Paravalvular regurgitation was diagnosed in 3 (10.7%) patients in group 1 and in 1 (4.2%) patient in group 2 (P=0.220). Conclusions: Su-AVR resulted in shorter cross-clamp and CPB times. However, early mortality, postoperative morbidity, and echocardiography results were similar between groups.

Ring Fracture of Brazilian Aortic Valve Bioprostheses Using Non-Compliant High-Pressure Transcatheter Balloon, an Ex Vivo Test

ABSTRACT Introduction: Aortic valve bioprostheses ring fracture in valve-in-valve procedures has shown low complication rates and presents as an option in the treatment of patients at high risk for conventional surgery, avoiding high transvalvular gradients, which are associated with increased mortality. Some prostheses available in the market cannot be fractured. In an ex vivo test, the possibility of ring fracture of aortic valve bioprostheses produced in Brazil when submitted to radial force application using a high-pressure non-compliant balloon was evaluated. Methods: One unit of each aortic valve bioprosthesis model, sizes 19 and 21 mm, produced by Brazilian companies (Braile Biomédica, Cardioprótese, and Labcor), was used. In the experiment, a non-compliant high-pressure balloon (Atlas®-Gold), 1 mm larger than the external diameter of the prosthesis, was positioned inside the valve annulus and inflated gradually aiming to fracture the prosthesis. Fracture pressures and photographic and radiological images of the prostheses before and after test were recorded. Results: All prostheses were fractured. In the models with metal ring, the fracture pressures were between 23 and 25 atm. In the other prostheses, the rupture occurred between 10 and 13 atm. No deformations in the structure were observed, which could potentially damage the aortic root. Conclusion: All the Brazilian prostheses evaluated were fractured, although the presence of a metal ring in the prosthesis framework increases the pressure required for fracture. The information obtained helps in the planning of valve-in-valve procedures in patients with aortic valve bioprostheses.

Ring Fracture of Brazilian Aortic Valve Bioprostheses Using Non-Compliant High-Pressure Transcatheter Balloon, an Ex Vivo Test.

INTRODUCTION: Aortic valve bioprostheses ring fracture in valve-in-valve procedures has shown low complication rates and presents as an option in the treatment of patients at high risk for conventional surgery, avoiding high transvalvular gradients, which are associated with increased mortality. Some prostheses available in the market cannot be fractured. In an ex vivo test, the possibility of ring fracture of aortic valve bioprostheses produced in Brazil when submitted to radial force application using a high-pressure non-compliant balloon was evaluated. METHODS: One unit of each aortic valve bioprosthesis model, sizes 19 and 21 mm, produced by Brazilian companies (Braile Biomédica, Cardioprótese, and Labcor), was used. In the experiment, a non-compliant high-pressure balloon (Atlas®-Gold), 1 mm larger than the external diameter of the prosthesis, was positioned inside the valve annulus and inflated gradually aiming to fracture the prosthesis. Fracture pressures and photographic and radiological images of the prostheses before and after test were recorded. RESULTS: All prostheses were fractured. In the models with metal ring, the fracture pressures were between 23 and 25 atm. In the other prostheses, the rupture occurred between 10 and 13 atm. No deformations in the structure were observed, which could potentially damage the aortic root. CONCLUSION: All the Brazilian prostheses evaluated were fractured, although the presence of a metal ring in the prosthesis framework increases the pressure required for fracture. The information obtained helps in the planning of valve-in-valve procedures in patients with aortic valve bioprostheses.

Outcomes Following Supracoronary Ascending Aortic Replacement with Aortic Valve Resuspension versus Modified Bentall's Operation for Acute Type A Aortic Dissection

Abstract Introduction: Type A acute aortic dissection (AAD) remains a challenging cardiac emergency despite the availability of various management strategies. This study compared the outcomes of supracoronary ascending aortic replacement (SCAAR) with aortic valve (AV) resuspension with those of modified Bentall's operation for type A AAD and the progression of aortic regurgitation (AR), long-term dilatation of aortic root and proximal arch, and long-term mortality in SCAAR patients. Methods: Sixty patients underwent surgery for type A AAD (January 2005 to December 2015). Forty-three patients underwent SCAAR with AV resuspension and 17 underwent modified Bentall's operation. All patients were followed up. Results: Upon follow-up of SCAAR patients (n=40), there was significant reduction in aortic root size (preoperative 39.3 mm [9.4] vs. postoperative 33.1 mm [9.1]; P<0.001). Three of these patients worsened to severe AR while others had similar or lesser degree of AR. On comparison between preoperative and postoperative dimensions of all patients (n=53), there was no significant difference in distal ascending aorta size (35.7 mm [8.1] vs. 34.4 mm [8.9]; P=0.52). However, an increase in descending thoracic aorta size (28.8 mm [7.8] vs. 33.7 mm [9.9]; P<0.001) was observed. In-hospital and late mortalities for SCAAR vs. modified Bentall's procedure were 11.7% (seven patients) (7% [3] vs. 23.5% [4]) and 28% (15 patients) (15% [6] vs. 69% [9]), respectively. Conclusion: SCAAR with AV resuspension is a safe surgical option for type A AAD. Preservation of AV is associated with better long-term outcomes and reduced mortality. Modified Bentall's operation may be associated with long-term mortality.