Durabilidad de prótesis valvulares aórticas biológicas: deterioro estructural e incidencia de eventos en el seguimiento alejado / Durability of Bioprosthetic Aortic Valves: Structural Deterioration and Incidence of Events at Long-Term Follow-Up

RESUMEN Introducción: En el tratamiento de la estenosis aórtica grave ha habido un cambio en la elección del tipo de prótesis valvular, con priorización de la utilización de válvulas biológicas. En la actualidad, a nivel mundial, en el 80% de los recambios valvulares aórticos se utilizan prótesis biológicas, cuya menor durabilidad alejada representa su mayor limitación. No contamos con evaluación reciente en nuestro medio de la durabilidad de las válvulas biológicas y la incidencia de eventos a largo plazo. Objetivos: Evaluar el comportamiento alejado de las prótesis valvulares aórticas biológicas, respecto de su sobrevida e incidencia ecocardiográfica de deterioro valvular estructural (DVE). Material y Métodos: Estudio retrospectivo sobre 2365 pacientes operados entre enero de 2003 y diciembre de 2023. Se evaluó la sobrevida alejada y la incidencia de DVE de acuerdo con las modificaciones del gradiente medio transprotésico (GMt) según la edad (dicotomizada en 60 años) y el tamaño de la prótesis utilizada (dicotomizado en 23 mm). Resultados: La edad promedio fue de 73 ± 3,05 años (105 pacientes < 60 años y 2530 pacientes ≥60 años). Sexo masculino en 63,4 %. Seguimiento alejado en el 92 % de los pacientes, media de 5,9 ± 3,2 años. Sobrevida a 5 y 10 años según edad: en < 60 años: 98,3 y 91,7 % vs. ≥ 60 años: 81,7 y 65,7 % (p=0,007) respectivamente. Seguimiento ecocardiográfico global en 1399 (59,7 %) pacientes. Valores del GMt basal, y a 5 y 10 años: a) según edad: en < 60 años: 16 ±3 mmHg, 16 ± 6 mmHg y 19 ± 5 mmHg, vs. en ≥ 60 años: 15 ± 5 mmHg, 16 ± 7 mmHg y 18± 7 mmHg (p=NS); b) según tamaño de la prótesis: en < 23 mm: 17±6 mmHg, 19±7 mmHg y 22± 7 mmHg, vs. en ≥ 23 mm: 15± 5 mmHg, 16± 6 mmHg y 18± 6 mmHg (p= 0,001). Conclusiones: Los pacientes con prótesis valvulares biológicas presentaron una elevada sobrevida alejada con diferencias según el grupo etario. Se registraron en el seguimiento diferencias del GMt (<10 mmHg) en las válvulas < 23 mm, demostrando baja incidencia de DVE grave.

ABSTRACT Background: In the treatment of severe aortic stenosis there has been a shift in the choice of the valve prosthesis type toward the use of biological valves. At present, bioprosthetic valves are used in 80% of aortic valve replacements worldwide. Their main limitation is their reduced long-term durability. No assessment has been yet performed in our setting regarding the durability of bioprosthetic valves and the incidence of long-term events. Objectives: To evaluate the long-term performance of bioprosthetic aortic valves related to survival and echocardiographic incidence of structural valve deterioration (SVD). Methods: A retrospective study of 2365 patients undergoing aortic valve replacement with biological prosthesis between January 2003 and December 2023. We analyzed the long-term survival and the incidence of SVD pursuant to changes in the mean transprosthetic gradient (mTPG) according to age (< or ≥60 years) and prosthetic valve size (< or ≥ 23 mm). Results: Mean age was 73±3.05 years (105 patients <60 years and 2530 patients ≥60 years). A total of 63.4% was male. Of patients, 92% completed a long-term follow-up, mean 5.9±3.2 years. Survival at 5 and 10 years according to age was: in patients <60 years: 98.3 and 91.7% vs. patients ≥60 years: 81.7 and 65.7% (p=0.007), respectively. A total of 1399 (59.7%) patients had an overall echocardiographic follow-up. The values of mTPG at baseline, 5 and 10 years were: a) according to age: in patients <60 years: 16±3 mmHg, 16±6 mmHg and 19±5 mmHg, vs. in patients ≥60 years: 15±5 mmHg, 16±7 mmHg and 18±7 mmHg (p=NS); b) according to prosthesis size: <23 mm: 17±6 mmHg, 19±7mmHg and 22±7 mmHg, vs. ≥23 mm: 15±5 mmHg, 16±6 mmHg and 18±6 mmHg (p= 0.001). Conclusions: Patients with bioprosthetic valves experienced high long-term survival with some differences according to age group. At follow-up, differences in mTPG (<10 mmHg) were observed in prosthetic valve sizes <23 mm, showing low incidence of severe SVD.

Válvulas de rápido implante versus válvulas tradicionales en reemplazo valvular aórtico en pacientes de riesgo intermedio / Rapid-Deployment Valve versus Conventional Valves in Aortic Valve Replacement in Intermediate-Risk Patients

RESUMEN Introducción: El reemplazo valvular aórtico (RVA) en pacientes con riesgo quirúrgico intermedio (RI) es el más desafiante al momento de decidir el tipo de prótesis a utilizar. Las válvulas de rápido implante (RD-V) serían una alternativa a considerar en este grupo específico. Objetivos: Comparar mortalidad temprana, complicaciones postoperatorias y parámetros hemodinámicos transvalvulares en el RVA con válvulas tradicionales vs. RD-V en pacientes de RI. Material y métodos: Estudio retrospectivo y observacional de pacientes consecutivos de RI (STS-PROM 4-8) intervenidos por RVA con prótesis tradicionales y RD-V en el período 2007-2023. Resultados: Se incluyeron 205 pacientes (140 con prótesis tradicionales vs. 65 con RD-V). El riesgo preoperatorio fue semejante en ambos grupos (STS-PROM 5,07% vs. 5,7%, p=0,210). El abordaje miniinvasivo fue más frecuente en RD-V (32,3% vs 0,7%, p<0,001). El tiempo de circulación extracorpórea y clampeo fue significativamente menor en RD-V (134,5 vs.100 min y 104 vs 73 min respectivamente, p<0,001). Hubo tendencia a menor implante de marcapasos con las válvulas tradicionales (4,3% vs. 10,8%, p=0,075). No se observaron diferencias significativas en las complicaciones postoperatorias; hubo fuerte tendencia a menor mortalidad a los 30 días con RD-V (0% vs. 5,7% para válvulas tradicionales, p=0,057). El gradiente protésico medio postoperatorio fue significativamente menor para el grupo RD-V (7,90±3,3 mmHg vs. 12,74±6,07 mmHg, p<0,001). No hubo diferencias respecto a incidencia de trombosis valvular o endocarditis protésica. Conclusiones: Las válvulas de rápido implante presentaron tendencia a menor mortalidad, menor tiempo de circulación extracorpórea/clampeo, mejor perfil hemodinámico y mayor facilidad de implante por abordaje miniinvasivo.

ABSTRACT Background: Aortic valve replacement (AVR) in intermediate-risk (IR) patients is particularly challenging when determining the type of prosthesis to use. Rapid-deployment valves (RD-V) are emerging as a potential alternative in this patient population. Objectives: To compare early mortality, postoperative complications, and transvalvular hemodynamic parameters between AVR with conventional valves and RD-V in IR patients. Methods: We conducted a retrospective observational study of consecutive IR patients (STS-Prom score 4-8) undergoing AVR with conventional prostheses and RD-V between 2007 and 2023. Results: A total of 205 patients were included (140 AVR vs. 65 RD-V). Surgical risk was similar between both groups (STS-Prom 5.07 % vs. 5.7 % respectively, p = 0.210). The minimally invasive approach was more common in the RD-V group (32.3% vs. 0.7%, p < 0.001). The cardiopulmonary bypass time and aortic cross-clamp time was significantly shorter in the RD-V group (134.5 vs. 100 min and 104 vs. 73 min, respectively, p < 0.001). There was a trend to lower incidence of pacemaker implantation in the conventional valve group (4.3% vs. 10.8%, p = 0.075). There were no significant differences in postoperative complications, and a strong trend to lower 30-dat mortality with RD-V (0% vs. 5.7% for conventional valves, p = 0.057). The mean postoperative gradient across the prosthesis was significantly lower in the RD-V group (7.90 ± 3.3 mm Hg vs. 12.74 ± 6.07 mm Hg, p < 0.001). There were no differences in the incidence of valve thrombosis or prosthetic endocarditis. Conclusions: Rapid deployment valves demonstrated trend to lower mortality, shorter cardiopulmonary bypass time and aortic cross-clamp time, improved hemodynamic profile, and were easier to implant via a minimally invasive approach.

Curva de Aprendizagem da Mortalidade Hospitalar da Substituição da Válvula Aórtica Transcateter: Insights do Registro Nacional Brasileiro / Learning Curve for In-Hospital Mortality of Transcatheter Aortic Valve Replacement: Insights from the Brazilian National Registry

Resumo Fundamento Dados robustos sobre a curva de aprendizagem (LC) da substituição da válvula aórtica transcateter (TAVR) são escassos nos países em desenvolvimento. Objetivo Avaliar a LC da TAVR no Brasil ao longo do tempo. Métodos Analisamos dados do registro brasileiro de TAVR de 2008 a 2023. Pacientes de cada centro foram numerados cronologicamente em número sequencial de caso (NSC). A LC foi realizada usando um spline cúbico restrito ajustado para o EuroSCORE-II e o uso de próteses de nova geração. Ainda, os desfechos hospitalares foram comparados entre grupos definidos de acordo com o nível de experiência, com base no NSC: 1º ao 40º caso (experiência inicial), 41º ao 80º caso (experiência básica), 81º ao 120º caso (experiência intermediária) e 121º caso em diante (experiência alta). Análises adicionais foram conduzidas de acordo com o número de casos tratados antes de 2014 (>40 e ≤40 procedimentos). O nível de significância adotado foi p <0,05. Resultados Foram incluídos 3194 pacientes de 25 centros. A idade média foi 80,7±8,1 anos e o EuroSCORE II médio foi 7±7,1. A análise da LC demonstrou uma queda na mortalidade hospitalar ajustada após o tratamento de 40 pacientes. Um patamar de nivelamento na curva foi observado após o caso 118. A mortalidade hospitalar entre os grupos foi 8,6%, 7,7%, 5,9%, e 3,7% para experiência inicial, básica, intermediária e alta, respectivamente (p<0,001). A experiência alta foi preditora independente de mortalidade mais baixa (OR 0,57, p=0,013 vs. experiência inicial). Centros com baixo volume de casos antes de 2014 não mostraram uma redução significativa na probabilidade de morte com o ganho de experiência, enquanto centros com alto volume de casos antes de 2014 apresentaram uma melhora contínua após o caso de número 10. Conclusão Observou-se um fenômeno de LC para a mortalidade hospitalar do TAVR no Brasil. Esse efeito foi mais pronunciado em centros que trataram seus 40 primeiros casos antes de 2014 que naqueles que o fizeram após 2014.

Abstract Background Robust data on the learning curve (LC) of transcatheter aortic valve replacement (TAVR) are lacking in developing countries. Objective To assess TAVR's LC in Brazil over time. Methods We analyzed data from the Brazilian TAVR registry from 2008 to 2023. Patients from each center were numbered chronologically in case sequence numbers (CSNs). LC was performed using restricted cubic splines adjusted for EuroSCORE-II and the use of new-generation prostheses. Also, in-hospital outcomes were compared between groups defined according to the level of experience based on the CSN: 1st to 40th (initial-experience), 41st to 80th (early-experience), 81st to 120th (intermediate-experience), and over 121st (high-experience). Additional analysis was performed grouping hospitals according to the number of cases treated before 2014 (>40 and ≤40 procedures). The level of significance adopted was <0.05. Results A total of 3,194 patients from 25 centers were included. Mean age and EuroSCORE II were 80.7±8.1 years and 7±7.1, respectively. LC analysis demonstrated a drop in adjusted in-hospital mortality after treating 40 patients. A leveling off of the curve was observed after case #118. In-hospital mortality across the groups was 8.6%, 7.7%, 5.9%, and 3.7% for initial-, early-, intermediate-, and high-experience, respectively (p<0.001). High experience independently predicted lower mortality (OR 0.57, p=0.013 vs. initial experience). Low-volume centers before 2014 showed no significant decrease in the likelihood of death with gained experience, whereas high-volume centers had a continuous improvement after case #10. Conclusion A TAVR LC phenomenon was observed for in-hospital mortality in Brazil. This effect was more pronounced in centers that treated their first 40 cases before 2014 than those that reached this milestone after 2014.

Endocarditis por Haemophilus aphrophilus

La endocarditis infecciosa (EI) es una enfermedad causada por microorganismos que se asientan principalmente en las válvulas cardiacas. Frecuentemente ocurren por laceraciones orales, gastrointestinales y urogenitales, además de procedimientos médicos que pueden causar bacteriemia la cual conlleva a adherencia bacteriana e inflamación local y éstas a destrucción valvular(1,2). Las bacterias grampositivas son mayoritariamente asociadas a EI, y en menor proporción, las del grupo HACEK, saprofitos de la orofaringe, que son responsables de menos del 5% de casos(2-4). Se presenta el caso de un varón de 23 años con cuadro de 1 mes de evolución de sensación febril, sudoración y astenia; al que posteriormente se agrega tos productiva. Se plantea foco probable cardiológico por antecedentes y hallazgos físicos, retornando aislamiento del germen Haemophilus aphrophilus, microorganismo poco habitual.

Infective endocarditis (IE) is a disease caused by microorganisms that settle mainly in the heart valves. They frequently occur due to oral, gastrointestinal and urogenital lacerations, in addition to medical procedures that can cause bacteremia which leads to bacterial adhesion and local inflammation and these to valve destruction(1,2).. Gram-positive bacteria are mostly associated with IE, and to a lesser extent, those of the HACEK group, saprophytes of the oropharynx, which are responsible for less than 5% of cases(2-4). We present the case of a 23-year-old man with a 1-month history of fever, sweating, and asthenia; to which a productive cough is later added. A probable cardiological focus is proposed due to history and physical findings, returning isolation of the Haemophilus aphrophilus germ, an unusual microorganism.

Resumen: Consenso internacional para la nomenclatura y clasificación de la válvula aórtica bicúspide congénita y su aortopatía, con fines clínicos, quirúrgicos, intervencionistas y de investigación / Summary: International consensus statement on nomenclature and classification of the congenital bicuspid aortic valve and its aortopathy, for clinical, surgical, interventional and research purposes

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Abstract This consensus of nomenclature and classification for congenital bicuspid aortic valve and its aortopathy is evidence-based and intended for universal use by physicians (both pediatricians and adults), echocardiographers, advanced cardiovascular imaging specialists, interventional cardiologists, cardiovascular surgeons, pathologists, geneticists, and researchers spanning these areas of clinical and basic research. In addition, as long as new key and reference research is available, this international consensus may be subject to change based on evidence-based data1.

Factores predictivos negativos para hemorragia mayor en posoperados de cambio valvular aórtico por minitoracotomía / Negative predictors of major bleeding in postoperative aortic valve replacement via mini-thoracotomy

Resumen Introducción: La estenosis aórtica es la valvulopatía más común y requiere tratamiento quirúrgico. Las técnicas quirúrgicas mínimamente invasivas han surgido como alternativas a la esternotomía media tradicional. Objetivo: Analizar los posibles factores de riesgo asociados a la hemorragia mayor a lo habitual en pacientes sometidos a cambio valvular aórtico por minitoracotomía anterior derecha, y compartir los resultados encontrados en nuestro centro. Materiales y método: Se llevó a cabo un estudio observacional, longitudinal y retrospectivo con pacientes operados por minitoracotomía anterior derecha entre julio de 2015 a diciembre de 2022. Se recopilaron datos demográficos y clínicos, así como información sobre las variables generales y quirúrgicas relevantes. Resultados: Se observó una edad media de 58 años en los pacientes estudiados, con una mayor presencia de hombres menores de 65 años. De los pacientes estudiados, solo 3 (4.47%) presentaron hemorragia mayor a lo habitual. Se encontró una asociación entre la edad avanzada y el tiempo de circulación extracorpórea (minutos) con hemorragia mayor a lo habitual. Conclusiones: Los resultados del estudio indican que la incidencia de hemorragia mayor a lo habitual fue baja en la cirugía mínimamente invasiva realizada. La edad avanzada y el tiempo prolongado de circulación extracorpórea se identificaron como factores de riesgo significativos para hemorragia mayor a lo habitual. Sin embargo, se destaca la necesidad de realizar estudios con una muestra más amplia para comprender mejor estos factores y la seguridad de la cirugía mínimamente invasiva.

Abstract Introduction: Aortic stenosis is the most common valvular heart disease requiring surgical treatment. Minimally invasive surgical techniques have emerged as alternatives to traditional median sternotomy. Objective: To analyze the possible risk factors associated with major bleeding in patients undergoing aortic valve replacement via right anterior mini-thoracotomy and to share the results found in our center. Materials and methods: A retrospective, observational, longitudinal study was conducted in patients undergoing right anterior mini-thoracotomy from July 2015 to December 2022. Demographic and clinical data, as well as relevant surgical and echocardiographic variables, were collected. Results: The mean age of the study population had a mean age of 58 years, with a predominance of men under 65 years of age. Only three patients experienced major bleeding 4.47%. Advanced age and extracorporeal circulation time (minutes) were associated with bleeding. No significant differences were found in other variables analyzed. Conclusions: The study results indicate a low rate of postoperative bleeding in minimally invasive surgery. Advanced age and prolonged extracorporeal circulation time were identified as significant risk factors for major bleeding. However, further studies with a larger sample size are needed to better understand these factors and the safety of minimally invasive surgery.

Outcomes of Minimally Invasive Aortic Valve Replacement in Obese Patients: A Propensity-Matched Study

ABSTRACT Introduction: Obese patients are at risk of complications after cardiac surgery. The aim of this study is to investigate safety and efficacy of a minimally invasive approach via upper sternotomy in this setting. Methods: We retrospectively reviewed 203 obese patients who underwent isolated, elective aortic valve replacement between January 2014 and January 2023 - 106 with minimally invasive aortic valve replacement (MIAVR) and 97 with conventional aortic valve replacement (CAVR). To account for baseline differences, a propensity-matching analysis was performed obtaining two balanced groups of 91 patients each. Results: The 30-day mortality rate was comparable between groups (1.1% MIAVR vs. 0% CAVR, P=0.99). MIAVR patients had faster extubation than CAVR patients (6 ± 2 vs. 9 ± 2 hours, P<0.01). Continuous positive airway pressure therapy was less common in the MIAVR than in the CAVR group (3.3% vs. 13.2%, P=0.03). Other postoperative complications did not differ significantly. Intensive care unit stay (1.8 ± 1.2 vs. 3.2 ± 1.4 days, P<0.01), but not hospital stay (6.7 ± 2.1 vs. 7.2 ± 1.9 days, P=0.09), was shorter for MIAVR than for CAVR patients. Follow-up survival was comparable (logrank P-value = 0.58). Conclusion: MIAVR via upper sternotomy has been shown to be a safe and effective option for obese patients. Respiratory outcome was promising with shorter mechanical ventilation time and reduced need for post-extubation support. The length of stay in the intensive care unit was reduced. These advantages might be important for the obese patient to whom minimally invasive surgery should not be denied.

The Effect of Aortic Angulation on Clinical Outcomes of Patients Undergoing Transcatheter Aortic Valve Replacement

ABSTRACT Introduction: The aim of this study was to assess the impact of aortic angulation (AA) on periprocedural and in-hospital complications as well as mortality of patients undergoing Evolut™ R valve implantation. Methods: A retrospective study was conducted on 264 patients who underwent transfemoral-approach transcatheter aortic valve replacement with self-expandable valve at our hospital between August 2015 and August 2022. These patients underwent multislice computer tomography scans to evaluate AA. Transcatheter aortic valve replacement endpoints, device success, and clinical events were assessed according to the definitions provided by the Valve Academic Research Consortium-3. Cumulative events included paravalvular leak, permanent pacemaker implantation, new-onset stroke, and in-hospital mortality. Patients were divided into two groups, AA ≤ 48° and AA > 48°, based on the mean AA measurement (48.3±8.8) on multislice computer tomography. Results: Multivariable logistic regression analysis was performed to identify predictors of cumulative events, utilizing variables with a P-value < 0.2 obtained from univariable logistic regression analysis, including AA, age, hypertension, chronic renal failure, and heart failure. AA (odds ratio [OR]: 1.73, 95% confidence interval [CI]: 0.89-3.38, P=0.104), age (OR: 1.04, 95% CI: 0.99-1.10, P=0.099), hypertension (OR: 1.66, 95% CI: 0.82-3.33, P=0.155), chronic renal failure (OR: 1.82, 95% CI: 0.92-3.61, P=0.084), and heart failure (OR: 0.57, 95% CI: 0.27-1.21, P=0.145) were not found to be significantly associated with cumulative events in the multivariable logistic regression analysis. Conclusion: This study demonstrated that increased AA does not have a significant impact on intraprocedural and periprocedural complications of patients with new generation self-expandable valves implanted.

The Association Between Ascending Aortic and Left Ventricular Dimensions in Patients After Aortic Valve Replacement

ABSTRACT Introduction: Aortic valve replacement (AVR) is often recommended for patients with severe aortic stenosis or chronic aortic regurgitation. These conditions result in remodeling of the left ventricle, including increased interstitial fibrosis that may persist even after AVR. These structural changes impact left ventricular (LV) mechanics, causing compromised LV diameter to occur earlier than reduced LV ejection fraction (LVEF). The aim of this study was to examine the effect of left ventricular end-diastolic diameter (LVEDD) and its role in aortic expansion one year after AVR. Methods: Sixty-three patients who underwent AVR were evaluated. All patients underwent standard transthoracic echocardiography, which included measurements of the ascending aorta, aortic root, LVEF, and LVEDD before the surgery and one year postoperatively. Correlations between these variables were calculated. Results: All patients underwent AVR with either a mechanical or biological prosthetic aortic valve. Following AVR, there was a significant decrease in the dimensions of the ascending aorta and aortic root (both P=0.001). However, no significant changes were observed in LVEDD and LVEF. Correlations were found between the preoperative ascending aortic size and the preoperative and one-year postoperative LVEDD (r=0.419, P=0.001 and r=0.320, P=0.314, respectively). Additionally, there was a correlation between the postoperative ascending aortic size and the preoperative and one-year postoperative LVEDD (r=0.320, P=0.003 and r=0.136, P=0.335, respectively). Conclusion: The study findings demonstrate a significant correlation between the size of the aortic root and ascending aorta, before and after AVR. Additionally, a notable correlation was observed between postoperative LVEDD and the size of the aortic root.

Feasibility of Goal-Directed Fluid Therapy in Patients with Transcatheter Aortic Valve Replacement - An Ambispective Analysis

ABSTRACT Introduction: Goal-directed fluid therapy (GDFT) has been shown to reduce postoperative complications. The feasibility of GDFT in transcatheter aortic valve replacement (TAVR) patients under general anesthesia has not yet been demonstrated. We examined whether GDFT could be applied in patients undergoing TAVR in general anesthesia and its impact on outcomes. Methods: Forty consecutive TAVR patients in the prospective intervention group with GDFT were compared to 40 retrospective TAVR patients without GDFT. Inclusion criteria were age ≥ 18 years, elective TAVR in general anesthesia, no participation in another interventional study. Exclusion criteria were lack of ability to consent study participation, pregnant or nursing patients, emergency procedures, preinterventional decubitus, tissue and/or extremity ischemia, peripheral arterial occlusive disease grade IV, atrial fibrillation or other severe heart rhythm disorder, necessity of usage of intra-aortic balloon pump. Stroke volume and stroke volume variation were determined with uncalibrated pulse contour analysis and optimized according to a predefined algorithm using 250 ml of hydroxyethyl starch. Results: Stroke volume could be increased by applying GDFT. The intervention group received more colloids and fewer crystalloids than control group. Total volume replacement did not differ. The incidence of overall complications as well as intensive care unit and hospital length of stay were comparable between both groups. GDFT was associated with a reduced incidence of delirium. Duration of anesthesia was shorter in the intervention group. Duration of the interventional procedure did not differ. Conclusion: GDFT in the intervention group was associated with a reduced incidence of postinterventional delirium.

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.

Treatment For Infected Frozen Elephant Trunk Prosthesis Caused by Propionibacterium acnes: A Surgical Challenge

ABSTRACT In this article, we present the case of a 47-year-old man who underwent Bentall-Bono procedure and frozen elephant trunk prosthesis implantation due to severe aortic regurgitation and aortic dilatation with a second-time endovascular stent-graft repair in descending aorta. Over eight years, a subacute graft infection by Propionibacterium acnes was developed, culminating in cardiogenic shock secondary to severe aortic regurgitation due to a complete aortic root dehiscence because of multiple aortic pseudoaneurysms. The patient underwent emergency surgery in which the replacement of the graft by a biological valve tube was performed accompanied by a complete debranching of the three supra-aortic vessels.

Five-Year Follow-Up After Transcatheter Aortic Valve Implantation in Patients with Severe Aortic Stenosis and Concomitant Coronary Artery Disease: A Single-Center Experience

ABSTRACT Introduction: There is no consensus on the impact of coronary artery disease in patients undergoing transcatheter aortic valve implantation. Therefore, the objective of this study was, in a single-center setting, to evaluate the five-year outcome of transcatheter aortic valve implantation patients with or without coronary artery disease. Methods: All transcatheter aortic valve implantation patients between 2009 and 2019 were included and grouped according to the presence or absence of coronary artery disease. The primary endpoint, five-year all-cause mortality, was evaluated using Cox regression adjusted for age, sex, procedure years, and comorbidities. Comorbidities interacting with coronary artery disease were evaluated with interaction tests. In-hospital complications was the secondary endpoint. Results: In total, 176 patients had aortic stenosis and concomitant coronary artery disease, while 170 patients had aortic stenosis only. Mean follow-up was 2.2±1.6 years. There was no difference in the adjusted five-year all-cause mortality between transcatheter aortic valve implantation patients with and without coronary artery disease (hazard ratio 1.00, 95% confidence interval 0.59-1.70, P=0.99). In coronary artery disease patients, impaired renal function, peripheral arterial disease, or ejection fraction < 50% showed a significant interaction effect with higher five-year all-cause mortality. No significant differences in complications between the groups were found. Conclusion: Five-year mortality did not differ between transcatheter aortic valve implantation patients with or without coronary artery disease. However, in patients with coronary artery disease and impaired renal function, peripheral arterial disease, or ejection fraction < 50%, we found significantly higher five-year all-cause mortality.

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.

Tendência Temporal no Implante Percutâneo de Bioprótese Aórtica: Análise de 10 Anos do Registro TAVIDOR / Temporal Trends in Transcatheter Aortic Valve Implantation: 10-Year Analysis of the TAVIDOR Registry

Resumo Fundamento O implante percutâneo de bioprótese valvar aórtica (TAVI) consolidou-se como opção terapêutica da estenose aórtica de grau importante. Dados sobre as características evolutivas dos procedimentos e dos resultados obtidos com a técnica ao longo da última década, em escala nacional, são desconhecidos. Objetivos Analisar a tendência temporal referente ao perfil demográfico, características dos procedimentos e desfechos hospitalares de pacientes submetidos a TAVI na Rede D'Or São Luiz. Métodos Registro observacional envolvendo 29 instituições nacionais. Comparou-se características dos procedimentos realizados de 2012 a 2017 (Grupo 1) e de 2018 a 2023 (Grupo 2). Foram considerados significantes os resultados com valor de p < 0,05. Resultados Foram analisados 661 casos, 95 pertencentes ao Grupo 1 e 566 ao Grupo 2. A média de idade foi 81,1 anos. Observou-se no Grupo 1 maior prevalência de pacientes em classe funcional III ou IV e escore de risco > 8%. Foi mais frequente o emprego de anestesia geral, monitorização ecocardiográfica transesofágica e via de acesso por dissecção. Maior taxa de sucesso do procedimento (95,4% versus 89,5%; p = 0,018) foi aferida em implantes efetivados a partir de 2018, assim como menor mortalidade (3,9% versus 11,6%; p = 0,004) e necessidade de marcapasso definitivo (8,5% versus 17,9%; p = 0,008). Conclusões A análise temporal de 10 anos do Registro TAVIDOR demonstra uma queda na complexidade clínica dos pacientes. Além disso, o avanço para técnicas de implante minimalistas, somadas à evolução tecnológica dos dispositivos, podem ter contribuído para desfechos favoráveis dentre aqueles cujo implante ocorreu no último quinquênio.

Abstract Background Transcatheter aortic valve implantation (TAVI) has established itself as the preferential strategy to approach severe aortic stenosis. Information on procedural improvements and nationwide results obtained with the technique throughout the past decade are unknown. Objectives To assess the temporal variation of the demographic profile, procedural characteristics, and in-hospital outcomes of patients undergoing TAVI procedures at the Rede D'Or São Luiz. Methods Observational registry comprising 29 national institutions, comparing the characteristics of the TAVI procedures performed from 2012 to 2017 (Group 1) to those performed from 2018 to 2023 (Group 2). The statistical significance level adopted was p < 0.05. Results This study assessed 661 patients, 95 in Group 1 and 566 in Group 2, with a mean age of 81.1 years. Group 1 patients had a higher prevalence of New York Heart Association functional class III or IV and STS risk score > 8%. In addition, they more often underwent general anesthesia, transesophageal echocardiographic monitoring, and access through femoral dissection. Group 2 patients had a higher success rate of the TAVI procedure (95.4% versus 89.5%; p = 0.018), lower mortality (3.9% versus 11.6%; p = 0.004), and less often needed permanent pacemaker implantation (8.5% versus 17.9%; p = 0.008). Conclusions The 10-year temporal trends analysis of the TAVIDOR Registry shows a reduction in patients' clinical complexity over time. Furthermore, the advance to minimalistic implantation techniques, added to the technological evolution of the devices, may have contributed to the favorable outcomes observed among those whose implantation occurred in the last 5 years studied.

Outcomes of Transcatheter Aortic Valve Implantation in Patients with and without Diabetes Mellitus

ABSTRACT Introduction: Diabetes mellitus (DM) in patients undergoing cardiac transcatheter or surgical interventions usually is correlated with poor outcomes. Transcatheter aortic valve implantation (TAVI) has been developed as a therapy choice for inoperable, high-, or intermediate-risk surgical patients with severe aortic stenosis (AS). Objective: To evaluate the impact of DM and hemoglobin A1c (HbA1c) on outcomes and survival after TAVI. Methods: Five hundred and fifty-two symptomatic severe AS patients who underwent TAVI, of whom 164 (29.7%) had DM, were included in this retrospective study. Follow-up was performed after 30 days, six months, and annually. Results: The device success and risks of procedural-related complications were similar between patients with and without DM, except for acute kidney injury, which was more frequent in the DM group (2.4% vs. 0%, P=0.021). In-hospital and first-year mortality were similar between the groups (4.9% vs. 3.6%, P=0.490 and 15.0% vs. 11.2%, P=0.282, respectively). There was a statistical difference between HbA1c ≥ 6.5 and HbA1c ≤ 6.49 groups in total mortality (34.4% vs. 15.8%, P<0.001, respectively). The only independent predictors were Society of Thoracic Surgeons score (hazard ratio [HR] 1.28, 95% confidence interval [CI] 1.09-1.51; P=0.003) and HbA1c level ≥ 6.5 (HR 10.78, 95% CI 2.58-21.50; P=0.003) in multivariable logistic regression analysis. Conclusion: In this study, we conclude that DM was not correlated with an increased mortality risk or complication rates after TAVI. Also, it was shown that mortality was higher in patients with HbA1c ≥ 6.5, and it was an independent predictor for long-term mortality.

Sutureless Aortic Valve Replacement vs. Transcatheter Aortic Valve Implantation in Patients with Small Aortic Annulus: Clinical and Hemodynamic Outcomes from a Multi-Institutional Study

ABSTRACT Objective: This study aimed to compare hemodynamic performances and clinical outcomes of patients with small aortic annulus (SAA) who underwent aortic valve replacement by means of sutureless aortic valve replacement (SUAVR) or transcatheter aortic valve implantation (TAVI). Methods: From 2015 to 2020, 622 consecutive patients with SAA underwent either SUAVR or TAVI. Through a 1:1 propensity score matching analysis, two homogeneous groups of 146 patients were formed. Primary endpoint: all cause-death at 36 months. Secondary endpoints: incidence of moderate to severe patient-prosthesis mismatch (PPM) and incidence of major adverse cardiovascular and cerebrovascular events (MACCEs) Results: All-cause death at three years was higher in the TAVI group (SUAVR 12.2% vs. TAVI 21.0%, P=0.058). Perioperatively, comparable hemodynamic performances were recorded in terms of indexed effective orifice area (SUAVR 1.12 ± 0.23 cm2/m2 vs. TAVI 1.17 ± 0.28 cm2/m2, P=0.265), mean transvalvular gradients (SUAVR 12.9 ± 5.3 mmHg vs. TAVI 12.2 ± 6.2 mmHg, P=0.332), and moderate-to-severe PPM (SUAVR 4.1% vs. TAVI 8.9%, P=0.096). TAVI group showed a higher cumulative incidence of MACCEs at 36 months (SUAVR 18.1% vs. TAVI 32.6%, P<0.001). Pacemaker implantation (PMI) and perivalvular leak ≥ 2 were significantly higher in TAVI group and identified as independent predictors of mortality (PMI: hazard ratio [HR] 3.05, 95% confidence interval [CI] 1.34-6.94, P=0.008; PPM: HR 2.72, 95% CI 1.25-5.94, P=0.012). Conclusion: In patients with SAA, SUAVR and TAVI showed comparable hemodynamic performances. Moreover, all-cause death and incidence of MACCEs at follow-up were significantly higher in TAVI group.

Ascending Aortic Progression After Isolated Aortic Valve Replacement Among Patients with Bicuspid and Tricuspid Aortic Valves

ABSTRACT Objectives: The aims of the present study were to compare the long-term outcomes for ascending aortic dilatation and adverse aortic events after isolated aortic valve replacement between patients with bicuspid aortic valve (BAV) and tricuspid aortic valve ( TAV). Methods: This retrospective study included 310 patients who had undergone isolated aortic valve replacement with an ascending aorta diameter ≤ 45 mm between January 2010 and September 2021. The patients were divided into BAV group (n=90) and TAV group (n=220). The differences in the dilation rate of the ascending aorta and long-term outcomes were analyzed. Results: Overall survival was 89 ± 4% in the BAV group vs. 75 ± 6% in the TAV group at 10 years postoperatively (P=0.007), yet this difference disappeared after adjusting exclusively for age (P=0.343). The mean annual growth rate of the ascending aorta was similar between the two groups during follow-up (0.5 ± 0.6 mm/year vs. 0.4 ± 0.5 mm/year; P=0.498). Ten-year freedom from adverse aortic events was 98.1% in the BAV group vs. 95.0% in the TAV group (P=0.636). Multivariable analysis revealed preoperative ascending aorta diameter to be a significant predictor of adverse aortic events (hazard ratio: 1.76; 95% confidence interval: 1.33 to 2.38; P<0.001). Conclusion: Our study revealed that the long-term survival and the risks of adverse aortic events between BAV and TAV patients were similar after isolated aortic valve replacement. BAV was not a risk factor of adverse aortic events.