Resultados del implante percutáneo de válvula aórtica (TAVI). Experiencia después de la primera década desde la introducción de la técnica / Transcatheter aortic-valve implantation. A ten years clinical experience

BACKGROUND: Transcatheter aortic-valve implantation (TAVI) was introduced in 2002 and the first implants in our country were performed in 2010. AIM: To review the TAVI experience in our hospital, considering the technology improvements and gained experience throughout this period. MATERIAL AND METHODS: All patients undergoing TAVI in our center were included. Results and complications were adjudicated according to the Valve Academic Research Consortium-2 (VARC-2) criteria. Patients were divided in 3 groups, according to procedural year: Period 1: 2010-2015 (n = 35); Period 2: 2016-2018 (n = 35); Period 3: 2019-2021 (n = 41). Mortality up to one year after the procedure was recorded. RESULTS: Between 2010 and 2021, 111 TAVI procedures were performed. The mean age of patients was 82 years and 47% were women. Risk scores for in-hospital mortality were STS 6.7%, EUROSCORE II 8.0% and ACC/STS TAVR Score 4.9%. The trans-femoral route was used in 88% and a balloon-expandable valve was chosen in 82% of patients. A successful implant was achieved in 96%, with an in-hospital mortality of 1.8%. Mortality at 30 days and 1-year were 2.7 and 9.0%, respectively. During period 3, 100% of implants were successful, with no in-hospital mortality, less vascular complications (p < 0.01), less stroke (p = 0.04), less severe paravalvular leak (p = 0.01) and significantly lower rate of acute complications (p < 0.01). CONCLUSIONS: TAVI achieves excellent results. With greater experience and better available technologies, these results are even more favorable.

Proteína C-reativa como marcador prognóstico de mortalidade no mprimeiro ano após implante de válvula aórtica transcateter em estenose aórtica / C-reactive protein as a prognostic marker of 1-year mortality after transcatheter aortic valve implantation in aortic stenosis

Resumo Fundamento: A proteína C-reativa (PCR) é um biomarcador de inflamação preditor de eventos adversos em procedimentos cardiovasculares. Na avaliação do implante da válvula aórtica transcateter (transcatheter aortic valve implantation, TAVI) em relação ao prognóstico de longo prazo ainda é incipiente. Objetivo: Avaliar a PCR como marcador prognóstico no primeiro ano pós-TAVI na estenose aórtica (EAo). Métodos: A PCR foi avaliada na primeira semana do peroperatório numa coorte de casos retrospectiva com EAo. Correlacionou-se a PCR pré- e pós-TAVI com a mortalidade e foram pesquisados fatores preditores de mortalidade em 1 ano. Realizada regressão de Cox multivariada para identificar os preditores independentes de óbito em 1 ano. Resultados: Estudados 130 pacientes submetidos a TAVI, com mediana de idade de 83 anos, sendo 49% deles do sexo feminino. A PCR pré-TAVI elevada (> 0,5 mg/dL) ocorreu em 34,5% dos casos. O pico de PCR foi 7,0 (5,3-12,1) mg/dL no quarto dia. A mortalidade em 1 ano foi 14,5% (n = 19), sendo maior nos grupos com PCR pré-TAVI elevada (68,8% vs 29,1%; p = 0,004) e pico de PCR ≥ 10,0 mg/dL (64,7% vs 30,8%; p = 0,009). Os fatores preditores independentes de mortalidade foram insuficiência renal aguda (IRA) [razão de risco (RR) = 7,43; intervalo de confiança de 95% (IC95%), 2,1-24,7; p = 0,001], PCR pré-TAVI elevada [RR = 4,15; IC95%, 1,3-12,9; p=0,01] e hemotransfusão volumosa [HR = 4,68; 1,3-16,7; p = 0,02]. Conclusões: A PCR pré-TAVI elevada mostrou-se fator preditor independente de mortalidade no primeiro ano, assim como a ocorrência de IRA e hemotransfusões volumosas.

Abstract Background: C-reactive protein (CRP) is an inflammation biomarker that can be a predictor of adverse events in cardiovascular procedures. Its use in the assessment of long-term prognosis of transcatheter aortic valve implantation (TAVI) is still incipient. Objective: To evaluate CRP as a prognostic marker in the first year after TAVI in aortic stenosis (AoS). Methods: CRP was assessed on the first postoperative week in a retrospective cohort of patients with AoS. Pre- and post- CRP levels were correlated with mortality, and predictors of 1-year mortality were investigated. Multivariate Cox regression was performed to identify independent factors of 1-year mortality. Results: This study evaluated 130 patients who underwent TAVI, with median age of 83 years, and 49% of women. High pre-TAVI CRP (> 0.5 mg/dL) was observed in 34.5% of the cases. Peak CRP was 7.0 (5.3-12.1) mg/dL no quarto dia. The rate of 1-year mortality was 14.5% (n = 19), being greater in the groups with high pre-TAVI CRP (68.8% vs 29.1%; p = 0,004) and with peak CRP ≥ 10.0 mg/dL (64.7% vs 30.8%; p = 0,009). Independent predictors of mortality were acute renal failure (ARF) (hazard ratio [HR] = 7.43; 95% confidence interval [95%CI], 2.1-24.7; p = 0,001), high pre-TAVI CRP (HR 4.15; 95%CI, 1.3-12.9; p = 0.01), and large blood transfusion [HR 4,68; 1,3-16,7; p = 0.02]. Conclusions: High pre-TAVI CRP showed to be an independent predictor of 1-year mortality, as well as the presence of ARF and large blood transfusions.

Step-by-Step Minimally Invasive Aortic Valve Replacement: the RAT Approach

Abstract In the growing era of transcatheter aortic valve implantation, it is crucial to develop minimally invasive surgical techniques. These methods enable easier recovery from surgical trauma, especially in elderly and frail patients. Minimally invasive aortic valve replacement (MIAVR) is frequently performed via upper hemisternotomy. We describe MIAVR via right anterior thoracotomy, which is associated with less trauma, rapid mobilization, lower blood transfusion rates, and lower risk of postoperative wound infections. As minimally invasive procedures tend to take longer operative times, we suggest using rapid-deployment valve prostheses to overcome this limitation. This description focuses on the technical aspects and preoperative assessment.

Resultados clínicos del reemplazo valvular aórtico percutáneo con dispositivo balón expandible MyVal en estenosis aórtica severa de alto riesgo / Clinical results of percutaneous aortic valve replacement using the MyVal prosthesis in patients with severe aortice stenosis and hisgh surgical risk

INTRODUCCIÓN: El dispositivo MyVal balón-expandible (Meril Life Sciences, India) fue recientemente aprobado en Chile y la Unión Europea para uso comercial. El objetivo del presente estudio fue proveer datos de eficacia y seguridad temprana y de mediano plazo en pacientes portadores de estenosis aórtica (EA) severa de alto riesgo quirúrgico sometidos a reemplazo valvular aórtico percutáneo (RVAP) con dispositivo MyVal. MATERIAL Y MÉTODOS: Se enrolaron retrospectivamente todos los pacientes con EA severa sintomática de alto riesgo según criterio del ´heart team´ local, sometidos a RVAP usando prótesis MyVal en Hospital San Borja Arriarán. RESULTADOS: La población quedó compuesta por 14 sujetos tratados entre Octubre 2018 y Noviembre 2019. La población tuvo una edad media de 82,5±7,8 años y elevado perfil de riesgo (puntaje STS promedio 11,6±5,1% de mortalidad a 30 días). Se logró éxito de dispositivo y procedimiento en 12 pacientes (86%) con caída sustancial de la gradiente aórtica media, persistente a 6 meses de seguimiento sin insuficiencia aórtica más que leve. Ocurrió falla de dispositivo en 2 pacientes, una debida a falla de entrega y otra por embolización a ventrículo, esta última con resultado de muerte. En términos de complicaciones, ocurrió una muerte precoz atribuida a disección/ruptura de aorta y 2 hemorragias mayores. La tasa de marcapasos ascendió a 3 pacientes, 23% considerando todos quienes recibieron implante. CONCLUSIÓN: El presente registro cuestiona la seguridad de MyVal en el tratamiento percutáneo de la EA severa de alto riesgo. Sin embargo, una vez logrado un implante exitoso MyVal muestra adecuados parámetros de funcionamiento, persistentes a un plazo mediano de seguimiento.

BACKGROUND: The recently approved balloon expandable MyVal (Meril Life Sciences, India) transcatheter aortic valve replacement (TAVR) prosthesis is available for commercial use in Chile and the European Union. The aim of this study is to provide early and mid-term data on the safety and efficacy of patients with severe aortic stenosis (AS) at high surgical risk undergoing TAVR using the MyVal device. METHODS: All patients with symptomatic severe AS at high surgical risk undergoing intended TAVR with MyVal prosthesis at San Borja-Arriarán Hospital entered to a retrospective registry. RESULTS: Between October 2018 and November 2019, 14 patients entered to the registry. The mean age was 82.5±7.8 years-old with a high-surgical riskprofile (mean STS score of 11.6±5.1% for 30-day mortality). Device and procedural success were achieved in 12 patients (86%) with substantial decrease in the mean aortic gradient, persistent at 6 months follow-up, all with mild or trace aortic regurgitation. Device failure occurred in 2 patients, one due to failed delivery and other due to device embolization into the left ventricle, which resulted in patient death. There were one death attributed aortic dissection/rupture and two major bleeding episodes. Three patients receiving MyVal implant required the implantation of a permanent pacemaker (23%). CONCLUSION: The present registry rises a question upon the safety of the MyVal TAVR device in high-risk AS. However, once a successfully implant was achieved the MyVal prosthesis showed an adequate performance to mid-term follow-up.

Body mass index is associated with low postoperative cardiac output in patients undergoing aortic valve replacement / El índice de masa corporal se asocia a bajo gasto cardiaco postoperatorio de pacientes sometidos a reemplazo valvular aórtico

Abstract Background: Overweight and obesity (O/O) generate lipotoxicity of the cardiac fiber and increase the incidence and progression of aortic valve stenosis. The low cardiac output syndrome (LCOS) is a timing complication after to aortic valve replacement (AVR) surgery. Objective: The objective of the study was to investigate if body mass index (BMI) kg/m2 is a risk factor associated with LCOS and mortality in the post-operative period of AVR. Methods: A historic cohort study was designed, including patients with severe aortic stenosis (SAS), who were subjected to AVR. Results: 152 patients were included, 45 (29.6%), with normal weight (NW), 60 were overweight (39.5%), and 47 obese (30.9%). The prevalence of systemic hypertension (HT) was higher in O/O (p < 0.0001). Incidence of LCOS was 44.7%, being more frequent in the O/O groups compared to the NW group, 43.3%, 68.1%, and 22.2%, respectively, (p < 0.05 in overweight and p < 0.0001 in the obese). Assessing the presence or absence of LCOS associated with BMI as a numerical variable, we found that women, HT, BMI, left ventricular mass, and valve size, were associated with LCOS (p < 0.02, p < 0.02, p < 0.001, p < 0.032, and p < 0.045, respectively). Mortality was higher in patients who had LCOS (p < 0.02). Multivariate model showed that BMI was an independent risk factor for LCOS (odds ratio [OR] 1.21 [95% CI 1.08-1.35], p < 0.001). Conclusion: BMI is a risk factor associated to LCOS in the post-operative period of AVR in patients with SAS.

Resumen Antecedentes: El sobrepeso y la obesidad (O/O) generan lipotoxicidad de la fibra cardíaca y aumentan la incidencia y progresión de la estenosis de la válvula aórtica. El síndrome de bajo gasto cardíaco (SBGC) es una complicación postquirúrgica de la cirugía de reemplazo de válvula aórtica (RVA). Objetivo: Investigar si el índice de masa corporal kg/m2 (IMC) es un factor de riesgo asociado con SBGC y mortalidad en el postoperatorio de RVA. Métodos: Se diseñó un estudio de cohorte histórico, que incluyó pacientes con estenosis aórtica importante (EAI), que fueron sometidos a RVA. Resultados: Se incluyeron 152 pacientes, 45 (29.6%), con peso normal (N), 60 tenían sobrepeso (39.5%) y 47 obesos (30.9%). La prevalencia de hipertensión sistémica (HT) fue mayor en O/O (p < 0.0001). La incidencia de SBGC fue del 44.7%, siendo más frecuente en los grupos O/O en comparación con el grupo N, 43.3%, 68.1%, 22.2% respectivamente, (p < 0.05 en sobrepeso y p < 0.0001 en obesos). Al evaluar la presencia o ausencia de SBGC asociado con el IMC como una variable numérica, encontramos que las mujeres, HT, IMC, masa ventricular izquierda y tamaño de la válvula, se asociaron con SBGC (p < 0.02, p < 0.02, p < 0.001, p < 0.032, p < 0.045, respectivamente). La mortalidad fue mayor en pacientes con SBGC (p < 0.02). El modelo multivariado mostró que el IMC fue un factor de riesgo independiente asociado a SBGC [OR 1.21 (IC 95% 1.08-1.35), p < 0.001]. Conclusión: El IMC es un factor de riesgo asociado a SBGC en el postoperatorio de RVA en pacientes con EAI.

The influence of aortic pulse wave velocity on short-term functional capacity in patients with mild paravalvular regurgitation following transcatheter aortic valve implantation

Abstract Introduction: Recently, the clinical significance of mild paravalvular aortic regurgitation (PAR) has been evaluated and suggested that it can be predictor of clinical outcomes. In our study, we aimed to investigate the interaction of aortic pulse wave velocity (PWV) and mild PAR and their effects on the functional status of patients after transcatheter aortic valve implantation (TAVI). Methods: A total of 109 consecutive patients with symptomatic severe aortic stenosis were enrolled prospectively. After TAVI procedure, they were divided in to three groups according to PAR and PWV measurements. Patients without PAR were defined as the NonePAR group (n=60), patients with mild PAR and normal PWV were defined as the MildPAR-nPWV group (n=23), and patients with mild PAR and high PWV were defined as the MildPAR-hPWV group (n=26). Results: Compared with other groups, the MildPAR-hPWV group was older (P<0.001), hypertensive (P=0.015), and had a higher pulse pressure (P=0.018). In addition to PWV, this group had lower aortic regurgitation index (ARI) (P=0.010) and higher rate of New York Heart Association (NYHA) class II (at least) patients (P<0.001) in 30-day follow-up period. On multivariate regression analysis, the MildPARhPWV group (odds ratio=1.364, 95% confidence interval 1.221-1.843; P=0.011) as well as N-terminal-pro-brain natriuretic peptide levels and ARI were independently related with 30-day functional NYHA classification. However, NonePAR or MildPAR-nPWV group was not an independent predictor of early functional status. Conclusion: It was concluded that high PWV may adversely affect early functional status in patients with mild PAR in contrast to normal values following TAVI.

Immediate outcomes of aortic valve neocuspidization with glutaraldehyde-treated autologous pericardium: a multicenter study

Abstract Objective: To determine the feasibility of aortic valve neocuspidization (AVNeo) with glutaraldehyde-treated autologous pericardium. Methods: One hundred and seventy (170) AVNeo (84 males/86 females) were performed from January 2017 through March 2019 in three centers. All the records were prospectively collected and retrospectively reviewed. Results: Most of the patients were older than 60 years and over 95% were operated for aortic stenosis. Preoperatively, pressure gradients were 69.9±21.3 mmHg for patients with aortic stenosis, and the surgical annular diameter was 21.0±2.0 mm for all patients. Effective orifice area (EOA) and indexed EOA (iEOA) averaged 0.7±0.3 cm2 and 0.4±0.2 cm2/m2 for patients with aortic stenosis before surgery, respectively. There was no conversion to prosthetic aortic valve replacement. Eight patients needed reoperation for bleeding, but no patient needed reoperation due to early infective endocarditis. There were five in-hospital deaths due to noncardiac cause. Compared to preoperative echocardiographic measurements, postoperative peak pressure gradient decreased significantly (-58.7±1.7 mmHg; P<0.001) and reached 11.2±5.6 mmHg, and mean pressure gradient also decreased significantly (-36.8±1.1 mmHg; P<0.001) and reached 6.0±3.5 mmHg. Accordingly, EOA and iEOA increased significantly 2.0 cm2 and 1.0 cm2/m2 (both P<0.001) to reach 2.7±0.6 cm2 and 1.4±0.3 cm2/m2 after surgery, respectively, with minimal significant aortic regurgitation (0.6% > mild). Conclusion: AVNeo is feasible and reproducible with good clinical results. Hemodynamically, AVNeo produces immediate postoperative low-pressure gradients, large EOA, and minimal regurgitation of the aortic valve. Further studies are necessary to evaluate mid- and long-term evolution.

Transcatheter aortic valve implantation versus surgical aortic valve replacement for treatment of severe aortic stenosis: comparison of results from randomized controlled trials and real-world data

Abstract Objective: Results from randomized controlled trials (RCTs) and real-world study (RWS) appear to be discordant. We aimed to investigate whether data derived from RCTs and RWS evaluating long-term all-cause mortality of transcatheter aortic valve implantation (TAVI) versus surgical aortic valve replacement (SAVR) in patients with severe aortic stenosis (AS) were in agreement. Methods: RCTs or RWS comparing TAVI and SAVR, reporting longterm (≥2-year follow-up) all-cause mortality, were identified. We also carried out subgroup analyses to access the effect in different subgroups. A pre-designated data extraction form including 5 domains and 26 items was used to explore the relationship between RCTs and RWS. Mortality and effect in different subgroups were evaluated using random-effects meta-analyses. Results: Five RCTs (5421 participants, TAVI: 2759, SAVR: 2662) and 33 RWS (20839 participants; TAVI: 6585, SAVR: 14254) were identified. Pooled RCT analysis showed no difference in all-cause mortality between TAVI and SAVR (HR=0.97, 95% CI: 0.88-1.07; P=0.55). In RWS, TAVI was associated with an increased risk of allcause mortality (HR=1.46, 95% CI: 1.26-1.69; P<0.001) compared to SAVR. Conclusion: These results highlight the inconsistencies between RCTs and RWS in assessing long-term all-cause mortality in the treatment of AS using TAVI or SAVR, which may be caused by interactions of clinical characteristics or study design. RCTs as well as RWS are both developing and improving; the advantages of one kind of design, measurement and evaluation can and should be thoughtfully referred to the other.

The beneficial effect of anticoagulation in aortic bioprosthesis is associated with its size

Abstract Objective: To evaluate the clinical and echocardiographic outcomes in aortic valve replacement (AVR) patients with aortic bioprosthesis under oral anticoagulation (OA). Methods: Patients who underwent AVR with bioprosthesiswere prospectively enrolled. They were classified based on postoperative use of OA. Clinical and operative variables were collected. Echocardiographic and clinical follow-ups were performed two years after surgery. The primary outcome evaluated was change in transprosthetic gradient. Secondary outcomes analyzed were change in New York Heart Association (NYHA) class, major bleeding episodes, hospitalization, stroke, and transient ischemic attack. Results: We included 103 patients (61 without OA and 42 with OA). Clinical characteristics were similar among groups, except for younger age (76±6.3 vs. 72.4±8.1 years, P=0.016) and higher prevalence of atrial fibrillation (0% vs. 23.8%, P<0.001) in the OA group. Mean (21.4±10 mmHg vs. 16.8±7.7 mmHg, P=0.037) and maximum (33.4±13.7 mmHg vs. 28.4±10.2 mmHg, P=0.05) transprosthetic gradients were higher in patients without OA. Improvement in NYHA class was more frequent in patients with OA (73% vs. 45.3%, P=0.032). Major bleeding, stroke, and hospitalization were similar among groups. OA was the only independent predictor for improvement of NYHA class after multivariate logistic regression analysis (odds ratio [OR]: 5.9, 95% confidence interval [CI]: 1.2-29.4; P=0.028). Stratification by prosthesis size showed that patients with ≤ 21 mm prosthesis benefited from OA. Conclusion: Early anticoagulation after AVR with bioprosthesis was associated with significant decrease of transprosthesis gradient and improvement in NYHA class. These associations were seen mainly in patients with ≤ 21 mm prosthesis.

The prognostic value of c-reactive protein to albumin ratio in patients with isolated degenerative aortic valve stenosis undergoing surgical aortic valve replacement

Abstract Objective: To evaluate the prognostic value of C-reactive protein to albumin ratio (CAR) in patients with severe aortic valve stenosis undergoing surgical aortic valve replacement (AVR). Methods: Four hundred seventy-six patients with severe degenerative aortic stenosis who underwent successful isolated surgical AVR were enrolled. Hospitalization due to heart failure, surgical aortic reoperation, paravalvular leakage rates, and long-term mortality were evaluated in the whole study group. The participants were divided into two groups, as 443 patients without mortality (group 1) and 33 patients with mortality (group 2) during the follow-up time. Results: CAR was lower in patients without mortality than in those with mortality during the follow-up time (0.84 [0.03-23.43] vs. 2.50 [0.22-26.55], respectively, P<0.001). Age (odds ratio [OR]: 1.062, confidence interval [CI]: 1.012-1.114, P=0.014), CAR (OR: 1.221, CI: 1.125-1.325, P<0.001), ejection fraction (OR: 0.956, CI: 0.916-0.998, P=0.042), and valve type (OR: 2.634, CI: 1.045-6.638, P=0.040) were also found to be independent predictors of long-term mortality. Additionally, rehospitalization (0.86 [0.03-26.55] vs. 1.6 [0.17-24.05], P=0.006), aortic reoperation (0.87 [0.03-26.55] vs. 1.6 [0.20-23.43], P=0.016), and moderate to severe aortic paravalvular leakage (0.86 [0.03-26.55] vs. 1.86 [0.21-19.50], P=0.023) ratios were associated with higher CAR. Conclusion: It was firstly described that CAR was strongly related with increased mortality rates in patients with isolated severe aortic stenosis after surgical AVR. Additionally, rehospitalization, risk of paravalvular leakage, and aortic reoperation rates were higher in patients with increased CAR than in those without it.

Cardiopatía en el paciente anciano / Cardiovascular disease in the elderly

Las enfermedades cardiovasculares son muy frecuentes en la población anciana (pacientes mayores de 75 años). El enfrentamiento y manejo de ellas es distinto al indicado en pacientes jóvenes. Son escasos los estudios que incluyen población mayor de 75 años, con evidencia acerca de las diferencias que existen en la respuesta terapéutica en comparación al paciente joven. El anciano tiene mayor fragilidad y múltiples comorbilidades, con reserva cardiaca disminuida, lo que obliga a un manejo integral y acucioso. Los cambios propios de la edad repercuten tanto en riñón, cerebro, hígado, musculatura y corazón, lo que los hace pacientes más proclives a presentar complicaciones de la terapia farmacológica o intervencional. El objetivo de este artículo es resumir las recomendaciones sobre el manejo de las cardiopatías más frecuentes en el anciano, incluyendo insuficiencia cardiaca crónica, cardiopatía coronaria, hipertensión arterial, estenosis aórtica valvular y fibrilación auricular no valvular.

Cardiovascular diseases are very common in the elderly population, and their management is different. There are few studies that include population older than 75 years, with little evidence about the differences in the therapeutic response compared to the young patient. The elderly have greater fragility and multiple comorbidities, with diminished cardiac reserve, which requires a comprehensive and careful management. Changes due to advanced age, in kidney, brain, liver and musculature (among others), make them more vulnerable to complications of the pharmacological or interventional treatment. The objective of this article is to summarize the recommendations on the management of the most frequent heart diseases in the elderly, including chronic heart failure, coronary heart disease, arterial hypertension, valvular aortic stenosis, and non-valvular atrial fibrillation.

National trends in utilization and in-hospital outcomes of surgical aortic valve replacements in spain, 2001-2015

Abstract Objective: The aims of this study were to examine the incidence and in-hospital outcomes of surgical aortic valve replacement (SAVR) and to identify factors associated with in-hospital mortality (IHM) among patients according to the type of implanted valve used in SAVR. Methods: We performed a retrospective study using the Spanish National Hospital Discharge Database, 2001-2015. We included patients who had SAVR listed as a procedure in their discharge report. Results: We identified 86,578 patients who underwent SAVR (52.78% mechanical and 47.22% bioprosthetic). Incidence of SAVR coding increased significantly from 11.95 cases per 100,000 inhabitants in 2001 to 17.92 in 2015 (P<0.001). Age and comorbidities increased over time (P<0.001). There was a significant increase in the frequency of concomitant coronary artery bypass grafting (CABG) and in the use of pacemaker implantation. The use of mechanical SAVR decreased and the use of bioprosthetic valves increased over time. IHM decreased over time (from 8.13% in 2001-05 to 5.39% in 2011-15). Patients who underwent mechanical SAVR had higher IHM than those who underwent bioprosthetic SAVR (7.44% vs. 6%; P<0.05). Higher IHM rates were associated with advanced age, female sex, comorbidities, concomitant CABG, and the use of mechanical SAVR (OR 1.67; 95% CI 1.57-1.77). Conclusion: The number of SAVRs performed in Spain has increased since 2001. The use of mechanical SAVR has decreased and the use of bioprosthetic valves has increased over time. IHM has decreased over time for both types of valves and despite a concomitant increase in age and comorbidities of patients during the same period.

Hemodynamic and imaging assessment of transcatheter aortic valve replacement with the inovare® proseal using multislice computed tomography

Abstract Objective: To evaluate the hemodynamic performance (i.e., gradients and paravalvular leakage [PVL]) of the new and experimental Braile Inovare® Proseal. Additionally, we aimed to assess pre and postoperatively the aortic annulus and the transcatheter prosthesis using multislice computed tomography (MSCT). Methods: Patients were selected by a multidisciplinary heart team and referred for transcatheter aortic valve replacement (TAVR). MSCT was performed before and after surgery. Measurements of the aortic valve and prosthesis were conducted and correlated with the valve gradient and residual PVL. Results: Twenty-one patients were selected for the protocol. Patients had a mean age of 79 years and 38% of them were of female sex. The mean EuroSCORE II value was 12.5%±10.8. Mean gradient was reduced from 45.8±11.04 mmHg to 5.59±2.61 mmHg and there were no instances of PVL worse than mild. There were no cases of coronary obstruction or procedural death. Circularity was present in all prostheses evaluated. Circularity indexes for the prostheses were: inflow 0.05±0.03, middle third 0.04±0.02, and outflow 0.04±0.02 (P=0.08). The mean distance between the prosthesis and the left and right coronary ostia were 14.8 mm±3.3 and 17.3 mm±3, respectively. Oversizing was appropriate with a mean of 22.14%±6%. Conclusion: Braile Inovare® Proseal transcatheter device has demonstrated low gradients with low rates of PVL. Oversizing by annular measurements was adequate. MSCT was adequate to evaluate device sizing and has demonstrated preserved expansibility and circularity in the evaluated cases.

Is the newly defined r2cha2ds2-vasc score a predictor for late mortality in patients undergoing transcatheter aortic valve replacement?

Abstract Objective: To assess the performance of the modified R2CHA2DS2-VASc score for predicting mid-to-long-term mortality (> 30 days) in patients undergoing transcatheter aortic valve replacement (TAVR). Methods: Data of 78 patients who underwent TAVR were retrospectively reviewed. R2CHA2DS2-VASc score was compared with the European System for Cardiac Operative Risk Evaluation II (EuroSCORE II or ES II) and the transcatheter valve therapytranscatheter aortic valve replacement (TVT-TAVR) risk score. Results: The mean follow-up period was 17.4±9.9 months (maximum 37 months). Early mortality (first 30 days) was observed in 10 (12.8%) patients, whereas mid-to-long-term mortality (> 30 days) was observed in 26 (33.3%) patients. Non-survivors had higher values of R2CHA2DS2-VASc, ES II, and TAVR scores than survivors (P<0.001, P<0.001, and P=0.001, respectively). Analysis of Pearson's correlation revealed that R2CHA2DS2-VASc score was moderately correlated with ES II and TAVR scores (r=0.51, P<0.001; r=0.44, P=0.001, respectively). Pairwise comparisons of R2CHA2DS2-VASc (area under the curve [AUC]: 0.870, 95% confidence interval [CI]: 0.776-0.964; P<0.001), ES II (AUC: 0.801, 95% CI: 0.703-0.899; P<0.001), and TAVR scores (AUC: 0.730, 95% CI: 0.610-852; P=0.002) showed similar accuracy for predicting mortality. R2CHA2DS2-VASc score is an independent predictor of mortality in multivariable Cox regression analysis. A cutoff value of six for R2CHA2DS2-VASc score showed a sensitivity of 74% and a specificity of 89% for predicting mid-to-long-term mortality. Conclusion: R2CHA2DS2-VASc score, easily calculated from clinical parameters, is associated with prediction of mid-to-longterm mortality in patients undergoing TAVR.

German aortic valve score in risk assessment for surgical aortic valve replacement in a brazilian center

Abstract Objective: To test the German Aortic Valve (GAV) score at our university hospital in patients undergoing isolated aortic valve replacement (AVR). Methods: A total of 224 patients who underwent isolated conventional AVR between January 2015 and December 2018 were included. Patients with concomitant procedures and transcatheter aortic valve implantation were excluded. Patients' data were collected and analyzed retrospectively. Patients' risk scores were calculated according to criteria described by GAV score. Sensitivity, specificity, and accuracy (area under the ROC curve [AUC]) were also calculated. The calibration of the model was tested by the Hosmer-Lemeshow method. Results: The mortality rate was 8.04% (18 patients). The patients' mean age was 58.2±19.3 years and 25% of them were female (56 patients). Mean GAV score was 1.73±5.86 (min: 0.0; max: 3.53). The GAV score showed excellent discriminative capacity (AUC 0.925, 95% confidence interval 0.882-0.956; P<0.001). The cutoff "1.8" turned out to be the best discriminatory point with the best combination of sensitivity (88.9%) and specificity (75.7%) to predict operative death. Hosmer-Lemeshow method revealed a P-value of 0.687, confirming a good calibration of the model. Conclusion: The GAV score applies to our population with high predictive accuracy.

Enfoque minimalista en el implante de válvula aórtica percutánea / A minimalist approach for transcatheter aortic valve replacement

RESUMEN INTRODUCCIÓN: En pacientes con estenosis Aórtica (EA) severa sintomática, el implante de válvula aórtica percutánea transcatéter (TAVI) por vía transfemoral constituye el estándar de tratamiento en aquellos de riesgo quirúrgico intermedio o alto. El uso de un abordaje minimalista ha demostrado ser seguro y efectivo, si bien no existen reportes sobre la realidad nacional Métodos: Estudio descriptivo sobre la experiencia con pacientes sometidos al implante de TAVI bajo un protocolo minimalista en Unidad de Cardiología Intervencional y Hemodinamia del Hospital Sótero del Río desde Enero de 2018. Se analizaron las variables clínicas de los pacientes y del procedimiento así como desenlaces clínicos intrahospitalarios y seguimiento alejado. Resultados: Entre Enero 2018 hasta Abril 2019, un total de 10 pacientes fueron sometidos al implante de TAVI por vía transfemoral. El score STS-PROM promedio fue de 7,1. Se logró un implante exitoso en el 100% de los casos con un gradiente medio residual de 8 mmHg y sin leak moderado a severo en ningún paciente. No hubo eventos cerebrovasculares isquémicos perioperatorios ni muerte en este grupo. Se requirió implante de marcapasos definitivo en 3 pacientes y un paciente presentó hematoma femoral perioperatorio que requirió transfusión de glóbulos rojos. La mediana de la estadía hospitalaria fue de 2 días. Conclusiones: El uso de una estrategia minimalista para el implante de TAVI en nuestra realidad nacional es seguro y aplicable. Los resultados perioperatorios y a 30 días fueron comparables a los descritos en experiencias internacionales.

ABSTRACT BACKGROUND: In patients with symptomatic severe aortic stenosis, transcatheter percutaneous aortic valve implant (TAVI) is the standard treatment in those with intermediate or high surgical risk. The use of a minimalist approach has proven to be safe and effective, although there are no reports on the national reality Methods: Descriptive study on the experience with patients undergoing TAVI implantation under a minimalist protocol at the Interventional Cardiology and Hemodynamics Unit of the Hospital Sótero del Río since January 2018. Clinical characteristics of the patients and the procedure were analyzed as well as intrahospital outcomes and at 30-days follow up. Results: Between January 2018 and April 2019, a total of 10 patients underwent TAVI implantation by transfemoral approach in our institution. The average STS-PROM score was 7.1. A successful implant was achieved in 100% of cases with an average residual gradient of 8 mmHg and no moderate to severe leak in any patient. There were no perioperative ischemic cerebrovascular events nor death in this group. A definitive pacemaker implant was required in 3 patients and one patient developed femoral hematoma that required red blood cell transfusion. The median hospital stay was 2 days. Conclusions: The use of a minimalist strategy for TAVI implantation in our national reality is safe and applicable. Immediate results and at 30-days follow up were comparable to those described in international experiences.

Impact of Transcatheter Aortic Valve Implantation on Kidney Function / Impacto do Implante Percutâneo de Válvula Aórtica na Função Renal

Abstract Background: Chronic kidney disease (CKD) is frequently present in patients with aortic valve disease. Decreased kidney perfusion as a consequence of reduced cardiac output may contribute to renal dysfunction in this setting. Objective: Given the potential reversibility of kidney hypoperfusion after valve repair, this study aimed to analyze the impact of percutaneous transcatheter aortic valve implantation (TAVI) on kidney function. Methods: We performed a retrospective analysis of 233 consecutive patients who underwent TAVI in a single center between November 2008 and May 2016. We assessed three groups according to their baseline estimated glomerular filtration rate (eGFR) (mL/min/1.73 m2): Group 1 with eGFR ≥ 60; Group 2 with 30 ≤ eGFR < 60; and Group 3 with eGFR < 30. We analyzed the eGFR one month and one year after TAVI in these three groups, using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula to calculate it. Results: Patients from Group 1 had a progressive decline in eGFR one year after the TAVI procedure (p < 0.001 vs. pre-TAVI). In Group 2 patients, the mean eGFR increased one month after TAVI and continued to grow after one year (p = 0.001 vs. pre-TAVI). The same occurred in Group 3, with the mean eGFR increasing from 24.4 ± 5.1 mL/min/1.73 m2 before TAVI to 38.4 ± 18.8 mL/min/1.73 m2 one year after TAVI (p = 0.012). Conclusions: For patients with moderate-to-severe CKD, kidney function improved one year after the TAVI procedure. This outcome is probably due to better kidney perfusion post-procedure. We believe that when evaluating patients that might need TAVI, this 'reversibility of CKD effect' should be considered.

Resumo Fundamento: Pacientes com doença valvar aórtica frequentemente apresentam doença renal crônica (DRC). Diminuição da perfusão renal como consequência da redução do débito cardíaco pode contribuir para a disfunção renal neste cenário. Objetivo: Dado o potencial de reversibilidade da hipoperfusão renal após o reparo valvar, este estudo teve o objetivo de analisar o impacto do implante percutâneo de válvula aórtica (TAVI - transcatheter aortic valve implantation) na função renal. Métodos: Foi realizada uma análise retrospectiva de 233 pacientes consecutivos submetidos ao TAVI em um único centro, entre novembro de 2008 e maio de 2016. Três grupos foram avaliados de acordo com a taxa de filtração glomerular estimada (TFGe) basal (mL/min/1,73 m2): Grupo 1 com TFGe ≥ 60; Grupo 2 com 30 ≤ TFGe < 60; e Grupo 3 com TFGe < 30. O TFGe foi analisado nestes três grupos um mês e um ano após o TAVI e calculado usando a fórmula do Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI). Resultados: Os pacientes do Grupo 1 tiveram um declínio progressivo da TFGe um ano após o procedimento TAVI (p < 0,001 vs. pré-TAVI). Nos pacientes do Grupo 2, a média da TFGe aumentou um mês depois do TAVI e continuou crescendo depois de um ano (p = 0,001 vs. pré-TAVI). O mesmo ocorreu no Grupo 3, com a média da TFGe subindo de 24,4 ± 5,1 mL/min/1,73 m2 antes do TAVI para 38,4 ± 18,8 mL/min/1,73 m2 um ano após o TAVI (p = 0,012). Conclusões: Em pacientes com DRC moderada a grave, a função renal melhorou um ano após o procedimento TAVI. Este resultado é provavelmente devido à melhora da perfusão renal pós-procedimento. Acredita-se que, ao avaliar pacientes que possam precisar de TAVI, este 'efeito de reversibilidade da DRC' deva ser considerado.

Análise crítica dos estudos que mudaram a prática clínica recente: doença valvar / Critical analysis of studies that have changed recent clinical practice: valvular heart disease

Nesta breve análise crítica, discutiremos três estudos com potencial de alterar a prática clínica e as principais diretrizes internacionais no que tange à doença valvar. O estudo PARTNER III foi um estudo que randomizou 1000 pacientes de baixo risco cirúrgico entre troca valvar transcateter e cirurgia convencional, com superioridade da técnica transcateter em um desfecho primário combinado de mortalidade de todas as causas, acidente vascular cerebral (AVC) e re-hospitalização em doze meses de seguimento (8,5%vs.15,1%, p = 0,001). Já o estudo Evolut Low Risk randomizou 1468 pacientes entre as duas técnicas, com um desfecho primário de mortalidade ou AVC incapacitante ao final de dois anos de seguimento que atingiu não-inferioridade na comparação Bayesiana (5,3% transcateter vs . 6,7% cirurgia). Finalmente, discutimos também o estudo COAPT, no qual 614 pacientes foram randomizados entre o dispositivo edge-to-edge MitraClip e o tratamento clínico da insuficiência mitral secundária. Nesses pacientes selecionados, a taxa anualizada de hospitalizações por insuficiência cardíaca foi de 35,8% por paciente-ano no grupo MitraClip, comparado com 67,9% no grupo controle (HR 0,53, IC 95% 0,4-0,7).Nas novas diretrizes, pode-se razoavelmente esperar uma indicação I para a troca valvar transcateter em pacientes de baixo risco e uma indicação IIa para a técnica edge-to-edge em pacientes com características semelhantes aos do COAPT. Esses procedimentos devem ser considerados no contexto do Heart Team para que sejam atingidos os melhores resultados

In this short critical review, we will discuss three trials with the potential to alter clinical practice and the main international guidelines regarding valvular heart disease. The PARTNER III trial was a study of 1000 low surgical risk patients randomized between transcatheter aortic valve replacement (TAVR) and conventional surgery, showing the superiority of the transcatheter technique with a combined primary endpoint of all-cause mortality, stroke and rehospitalization over twelve months of follow-up (8.5%vs. 15.1%, p = 0.001). The Evolut Low Risk trial randomized 1468 patients between the two techniques with a primary endpoint of death or incapacitating stroke at the end of two years of follow-up, achieving non-inferiority in a Bayesian comparison (5.3% TAVR vs. 6.7% surgery). Finally, we also will discuss the COAPT study, in which 614 patients were randomized between the edge-to-edge MitraClip device and clinical treatment for secondary mitral regurgitation. Among these selected patients, the annual rate of hospitalizations for heart failure was 35.8% per patient-year in the MitraClip group, compared with 67.9% in the control group (HR 0.53, 95% CI 0.4-0.7). Under the new guidelines, we may reasonably expect a class I indication for transcatheter valvular replacement in low-risk patients and a class IIa indication for the edge-to-edge technique in patients with characteristics similar to those of the COAPT study. These procedures should be considered within the context of the Heart Team so that the best results are achieved

The negative effect of mean perfusion pressure on the development of acute kidney injury after transcatheter aortic valve implantation

Abstract Objective: To evaluate the predictive value of mean perfusion pressure (mPP) in the development of acute kidney injury (AKIN) after transcatheter aortic valve implantation (TAVI). Methods: One hundred and forty seven consecutive patients with aortic stenosis (AS) were evaluated for this study and 133 of them were included. Mean arterial pressure (mAP) and central venous pressure (CVP) were used to calculate mPP before TAVI procedure (mPP = mAP-CVP). The occurrence of AKIN was evaluated with AKIN classification according to the Valve Academic Research Consortium-2 recommendations. The patients were divided into two groups according to the receiver operating characteristic (ROC) analysis of their mPP levels (high-risk group and low-risk group). Results: The AKIN prevalence was 22.6% in this study population. Baseline serum creatinine level, glomerular filtration rate, amount of contrast medium, and the level of mPP were determined as predictive factors for the development of AKIN. Conclusion: The occurrence of AKIN is associated with increased morbidity and mortality rates in patients with TAVI. In addition to the amount of contrast medium and basal kidney functions, our study showed that lower mPP was strongly associated with development of AKIN after TAVI.