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.

Implantación percutánea transeptal de válvula protésica aórtica sobre bioprótesis mitral degenerada / Percutaneous implantation of an aortic prosthetic valve on a degenerated mitral bioprosthesis. Report of one case

Reintervention of a mitral degenerated bioprosthesis has a high surgical risk, especially in elderly patients with multiple comorbidities. We report a 74 years old female with two previous cardiac surgical procedures and a new structural mitral bioprosthesis deterioration with severe mitral regurgitation. Considering her high-surgical risk, a fully percutaneous treatment was performed with a balloon-expandable aortic valve in mitral position (valve-in-valve) through a transseptal approach with a favorable outcome. This technique is an attractive and effective option with a relatively low rate of complications that could solve this challenging and complex disease.

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.

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.

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.

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.

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.

Thrombocytopenia after transcatheter valve-in-valve implantation: prognostic marker or mere finding?

Abstract Objective: To analyze the behavior of platelets after transcatheter valve-in-valve implantation for the treatment of degenerated bioprosthesis and how they correlate with adverse events upon follow-up. Methods: Retrospective analysis of 28 patients who received a valve-in-valve implant, 5 in aortic, 18 in mitral and 5 in tricuspid positions. Data were compared with 74 patients submitted to conventional redo valvular replacements during the same period, and both groups' platelet curves were analyzed. Statistical analysis was conducted using the IBM SPSS Statistics(r) 20 for Windows. Results: All patients in the valve-in-valve group developed thrombocytopenia, 25% presenting mild (<150.000/µL), 54% moderate (<100.000/µL) and 21% severe (<50.000/µL) thrombocytopenia. The platelet nadir was on the 4th postoperative day for aortic ViV, 2nd for mitral and 3rd for tricuspid patients, with the majority of patients recovering regular platelet count. However, the aortic subgroup comparison between valve-in-valve and conventional surgery showed a statistically significant difference from the 7th day onwards, where valve-in-valve patients had more severe and longer lasting thrombocytopenia. This, however, did not translate into a higher postoperative risk. In our study population, postoperative thrombocytopenia did not correlate with greater occurrence of adverse outcomes and only normal preoperative platelet count could significantly predict a postoperative drop >50%. Conclusion: Although thrombocytopenia is an extremely common finding after valve-in-valve procedures, the degree of platelet count drop did not correlate with greater incidence of postoperative adverse outcomes in our study population.

Transcatheter aortic valve replacement: the experience of one brazilian health care center

Abstract Objective: Transcatheter aortic valve replacement has been an alternative to invasive treatment for symptomatic severe aortic stenosis in high risk patients. The primary endpoint was 30-day and 1-year mortality from any cause. Secondary endpoints were to compare the clinical and echocardiographic variation pre-and post- transcatheter aortic valve replacement, and the occurrence of complications throughout a 4-year follow-up period. Methods: This prospective cohort, nestled to a multicenter study (Registro Brasileiro de Implante de Bioprótese por Cateter), describes the experience of a public tertiary center in transcatheter aortic valve replacement. All patients who underwent this procedure between October 2011 and February 2016 were included. Results: Fifty-eight patients underwent transcatheter aortic valve replacement. The 30-day all-cause mortality was 5.2% (n=3) and after 1 year was 17.2% (n=10). A significant improvement in New York Heart Association functional classification was observed when comparing pre-and post- transcatheter aortic valve replacement (III or IV 84.4% versus 5.8%; P<0.001). A decline in peak was observed (P<0.001) and mean (P<0.001) systolic transaortic gradient. The results of peak and mean post-implant transaortic gradient were sustained after one year (P=0.29 and P=0.36, respectively). Left ventricular ejection fraction did not change significantly during follow-up (P=0.41). The most frequent complications were bleeding (28.9%), the need for permanent pacemaker (27.6%) and acute renal injury (20.6%). Conclusion: Mortality and complications in this study were consistent with worldwide experience. Transcatheter aortic valve replacement had positive clinical and hemodynamic results, when comparing pre-and post-procedure, and the hemodynamic profile of the prosthesis was sustained throughout follow-up.

Permanent Pacing After Transcatheter Aortic Valve Implantation: Incidence, Predictors and Evolution of Left Ventricular Function / Marca-passo Definitivo após Implante Valvar Aórtico Transcateter: Incidência, Preditores e Evolução da Função Ventricular Esquerda

Abstract Background: Transcatheter aortic valve implantation (TAVI) is a well-established procedure; however, atrioventricular block requiring permanent pacemaker implantation (PPI) is a common complication. Objectives: To determine the incidence, predictors and clinical outcomes of PPI after TAVI, focusing on how PPI affects left ventricular ejection fraction (LVEF) after TAVI. Methods: The Brazilian Multicenter TAVI Registry included 819 patients submitted to TAVI due to severe aortic stenosis from 22 centers from January/2008 to January/2015. After exclusions, the predictors of PPI were assessed in 670 patients by use of multivariate regression. Analysis of the ROC curve was used to measure the ability of the predictors; p < 0.05 was the significance level adopted. Results: Within 30 days from TAVI, 135 patients (20.1%) required PPI. Those patients were older (82.5 vs. 81.1 years; p = 0.047) and mainly of the male sex (59.3% vs 45%; p = 0.003). Hospital length of stay was longer in patients submitted to PPI (mean = 15.7 ± 25.7 vs. 11.8 ± 22.9 days; p < 0.001), but PPI affected neither all-cause death (26.7% vs. 25.6%; p = 0.80) nor cardiovascular death (14.1% vs. 14.8%; p = 0.84). By use of multivariate analysis, the previous presence of right bundle-branch block (RBBB) (OR, 6.19; 3.56-10.75; p ≤ 0.001), the use of CoreValve® prosthesis (OR, 3.16; 1.74-5.72; p ≤ 0.001) and baseline transaortic gradient > 50 mm Hg (OR, 1.86; 1.08-3.2; p = 0.025) were predictors of PPI. The estimated risk of PPI ranged from 4%, when none of those predictors was present, to 63%, in the presence of all of them. The model showed good ability to predict the need for PPI: 0.69 (95%CI: 0.64 - 0.74) in the ROC curve. The substudy of 287 echocardiograms during the 1-year follow-up showed worse LVEF course in patients submitted to PPI (p = 0.01). Conclusion: BRD prévio, gradiente aórtico médio > 50 mmHg e CoreValve® são preditores independentes de implante de MPD pós-TAVI. Ocorreu implante de MPD em aproximadamente 20% dos casos de TAVI, o que prolongou a internação hospitalar, mas não afetou a mortalidade. O implante de MPD afetou negativamente a FEVE pós-TAVI.

Resumo Fundamento: O implante valvar aórtico transcateter (TAVI) está bem estabelecido, porém, o bloqueio atrioventricular, com necessidade de marca-passo definitivo (MPD), é complicação frequente. Objetivo: Determinar a incidência, preditores e desfechos clínicos de implante de MPD após TAVI, focando em como a evolução da fração de ejeção do ventrículo esquerdo (FEVE), após o TAVI, é afetada pelo MPD. Métodos: No registro brasileiro foram incluídos 819 pacientes submetidos a TAVI por estenose aórtica severa em 22 centros entre janeiro/2008 e janeiro/2015. Após exclusões, os preditores de implante de MPD foram avaliados em 670 pacientes por regressão multivariada. Análise da curva ROC foi utilizada para medir a habilidade dos preditores; p < 0,05 foi considerado significativo. Resultados: Aos 30 dias, 135 pacientes (20,1%) necessitaram de MPD. Tais pacientes eram mais velhos (82,5 vs. 81,1 anos; p = 0,047) e predominantemente homens (59,3% vs 45%; p = 0,003). A permanência hospitalar foi maior no Grupo MPD (média= 15,7 ± 25,7 vs. 11,8 ± 22,9 dias; p < 0,001), mas o implante não afetou morte por qualquer causa (26,7% vs. 25,6%; p = 0,80) nem morte cardiovascular (14,1% vs. 14,8%; p = 0,84). Por análise multivariada, a presença prévia de bloqueio de ramo direito (BRD) (OR, 6,19; 3,56-10,75; p ≤ 0,001), o uso da prótese CoreValve® (OR, 3,16; 1,74-5,72; p ≤ 0,001) e gradiente transaórtico basal > 50 mmHg (OR, 1,86; 1,08-3,2; p= 0,025) foram preditores de implante de MPD. O risco estimado de implante de MPD foi 4%, quando nenhum dos fatores de risco estava presente, e 63% na presença de todos. O modelo mostrou boa habilidade de prever a necessidade de MPD: 0,69 (IC95%: 0,64 - 0,74) na curva ROC. Subestudo de 287 ecocardiogramas durante o seguimento de 1 ano mostrou pior evolução da FEVE no Grupo MPD (p = 0,01). Conclusão: Em crianças de 6 a 11 anos, circunferência da cintura aumentada está associada à PA elevada, mesmo quando o IMC é normal. (Arq Bras Cardiol. 2017; [online].ahead print, PP.0-0)

Desempenho de Escores de Risco Cirúrgico para Prever Mortalidade após Implante Transcateter de Valva Aórtica / Performance of Surgical Risk Scores to Predict Mortality after Transcatheter Aortic Valve Implantation

AbstractBackground:Predicting mortality in patients undergoing transcatheter aortic valve implantation (TAVI) remains a challenge.Objectives:To evaluate the performance of 5 risk scores for cardiac surgery in predicting the 30-day mortality among patients of the Brazilian Registry of TAVI.Methods:The Brazilian Multicenter Registry prospectively enrolled 418 patients undergoing TAVI in 18 centers between 2008 and 2013. The 30-day mortality risk was calculated using the following surgical scores: the logistic EuroSCORE I (ESI), EuroSCORE II (ESII), Society of Thoracic Surgeons (STS) score, Ambler score (AS) and Guaragna score (GS). The performance of the risk scores was evaluated in terms of their calibration (Hosmer–Lemeshow test) and discrimination [area under the receiver–operating characteristic curve (AUC)].Results:The mean age was 81.5 ± 7.7 years. The CoreValve (Medtronic) was used in 86.1% of the cohort, and the transfemoral approach was used in 96.2%. The observed 30-day mortality was 9.1%. The 30-day mortality predicted by the scores was as follows: ESI, 20.2 ± 13.8%; ESII, 6.5 ± 13.8%; STS score, 14.7 ± 4.4%; AS, 7.0 ± 3.8%; GS, 17.3 ± 10.8%. Using AUC, none of the tested scores could accurately predict the 30-day mortality. AUC for the scores was as follows: 0.58 [95% confidence interval (CI): 0.49 to 0.68, p = 0.09] for ESI; 0.54 (95% CI: 0.44 to 0.64, p = 0.42) for ESII; 0.57 (95% CI: 0.47 to 0.67, p = 0.16) for AS; 0.48 (95% IC: 0.38 to 0.57, p = 0.68) for STS score; and 0.52 (95% CI: 0.42 to 0.62, p = 0.64) for GS. The Hosmer–Lemeshow test indicated acceptable calibration for all scores (p > 0.05).Conclusions:In this real world Brazilian registry, the surgical risk scores were inaccurate in predicting mortality after TAVI. Risk models specifically developed for TAVI are required.

ResumoFundamento:Ainda é desafiador prever a mortalidade de pacientes que se submetem ao TAVI (sigla do inglês Transcatheter Aortic Valve Implantation).Objetivos:Avaliar o desempenho de cinco escores de risco para cirurgia cardíaca em prever mortalidade em 30 dias de pacientes inscritos no Registro Brasileiro de TAVI.Métodos:O Registro Multicêntrico Brasileiro inscreveu prospectivamente 418 pacientes submetidos ao TAVI em 18 centros entre 2008 e 2013. Os seguintes escores cirúrgicos foram usados para calcular o risco de mortalidade no período de 30 dias: EuroSCORE I (ESI) logístico, EuroSCORE II (ESII), STS Score (STS), Ambler Score (AS) e Guaragna Score (GS). O desempenho dos escores de risco foram avaliados através de sua calibração (teste Hosmer-Lemeshow) e discriminação [área sob a curva (AUC) do inglês receiver-operating characteristic curve)].Resultados:A idade média foi de 81,5 ± 7,7 anos. A prótese aórtica CoreValve (Medtronic) foi usada em 86,1% da coorte e a abordagem transfemural usada em 96,2%. A mortalidade observada no período de 30 dias foi de 9,1%. A mortalidade no período de 30 dias prevista pelos escores foi: ESI, 20,2 ± 13,8%; ESII, 6,5 ± 13,8%; STS, 14,7 ± 4,4%; AS, 7,0 ± 3,8%; GS, 17,3 ± 10,8%. Nenhum dos escores testados com a AUC foi capaz de prever a mortalidade no período de 30 dias de forma precisa. As AUC para os escores foram: 0,58 [95% de intervalo de confiança (IC): 0,49 a 0,68, p = 0,09] para ESI; 0,54 (IC de 95%: 0,44 a 0,64, p = 0,42) para ESII; 0,57 (IC de 95%: 0,47 a 0,67, p = 0,16) para AS; 0,48 (IC de 95%: 0,38 a 0,57, p = 0,68) para STS e 0,52 (IC de 95%: 0,42 a 0,62, p = 0,64) para GS. O teste Hosmer-Lemeshow indicou uma calibração aceitável para todos os escores (p > 0,05).Conclusões:Neste registro brasileiro de mundo real, os escores de risco cirúrgico foram imprecisos para prever a mortalidade após o TAVI. São necessários modelos de risco desenvolvidos especificamente para o TAVI.

Implante transcateter valve-in-valve para disfunção de biopróteses cirúrgicas aórticas / Transcatheter valve-in-valve implantation for surgical aortic bioprosthesis dysfunction

Introdução: Estudos recentes têm demonstrado a eficácia do implante transcateter valve-in-valve para otratamento de disfunção de biopróteses em pacientes de alto risco cirúrgico. Apresentamos nossa experiênciainicial com o implante valve-in-valve.Métodos: Caracterizamos o perfil clínico, ecocardiográfico e do procedimento, e reportamos os resultados de médio prazo de pacientes com disfunção de bioprótese submetidos a implante valve-in-valve em posição aórtica. Resultados: Incluímos sete pacientes do sexo masculino, com idade de 72,6 ± 10,0 anos. O escore STS foi 9,6± 10,5%, e o EuroSCORE logístico foi 22,7 ± 14,7%. Três pacientes apresentavam dupla disfunção; dois tinham insuficiência; e dois exibiam estenose isolada. A via transfemoral foi utilizada em seis casos, e a transapical, em um caso. Os dispositivos implantados incluíram as próteses Sapien XT (n = 5) e CoreValve (n = 2). O sucesso do procedimento foi obtido em seis (85,7%) casos. Após o procedimento, o gradiente médio reduziu-se de 38,2 ± 9,6mmHg para 20,9 ± 5,9 mmHg, e a área valvar elevou-se de 1,2 ± 0,4 cm2 para 1,5 ± 0,5 cm2. Ao final de 1 ano, nãoocorreram óbitos e nem outros desfechos adversos significativos; 80% dos pacientes encontravam-se em classefuncional NYHA I/II. Os gradientes transvalvares e a área valvar permaneceram inalterados nesse período. Conclusões: O procedimento valve-in-valve foi eficaz na maioria dos pacientes de alto risco cirúrgico comdisfunção de bioprótese. Quando realizado em pacientes bem selecionados, resulta em desfechos clínicos e hemodinâmicos satisfatórios.

Background: Recent studies have demonstrated the efficacy of the transcatheter valve-in-valveimplantation for the treatment of bioprosthesis dysfunction in high-risk surgical patients. This study presents the initial experience with valve-in-valve implantation. Methods: Clinical, echocardiographic, and procedural profiles were characterized, and the mid-term results of patients with surgical bioprosthesis dysfunction submitted to valve-in-valve implantation in theaortic position were reported.Results: Seven male patients were included, aged 72.6 ± 10.0 years. The STS score was 9,6 ± 10,5%, andthe logistic EuroSCORE was 22.7 ± 14.7%. Three patients had combined aortic bioprosthesis failure; two had isolated regurgitation; and two had isolated stenosis. The transfemoral access was used in six cases, and the transapical access in one case. Implanted devices included Sapien XT (n = 5) and CoreValve (n = 2) prostheses. Procedural success was achieved in six (85.7%) cases. After the procedure, the mean gradient decreased from 38.2 ± 9.6 mmHg to 20.9 ± 5.9 mmHg, and the valve area increased from 1.2 ±0.4 cm2 to 1.5 ± 0.5 cm2. After 1 year, there were no deaths and no other significant adverse outcomes; 80% of patients were in NYHA functional class I/II. The transvalvular gradients and valve area remained unchanged in this period.

Desfechos de curto e médio prazos de pacientes com e sem disfunção ventricular esquerda submetidos ao implante transcateter de prótese valvar aórtica / Short and medium-term outcomes of patients with and without left ventricular dysfunction submitted to transcatheter aortic valve implantation

Introdução: A utilização crescente do implante transcateter de prótese valvar aórtica (TAVI) em pacientes de alto risco, em especial naqueles com disfunção ventricular, justifica uma avaliação mais profunda da seleção e dos resultados do procedimento. Utilizamos nosso banco de dados para caracterizar o perfil dos pacientes e avaliar os resultados do TAVI de acordo com o grau de disfunção ventricular.Métodos: Estudo observacional longitudinal no qual foram incluídos todos os pacientes com estenose aórtica (EAo) grave, submetidos ao TAVI entre 2009 e 2014, e comparados àqueles com fração de ejeção do ventrículo esquerdo (FEVE) ≤ 40% vs. > 40%. Foram avaliados os desfechos de segurança e eficácia em 30dias e 1 ano. Resultados: Dentre os 172 pacientes, 20 (11,6%) apresentavam FEVE ≤ 40%. Esses pacientes eram mais jovens, com maior prevalência de tabagismo, infarto agudo do miocárdio prévio, cirurgia de revascularizaçãomiocárdica, marca-passo definitivo e hipertensão arterial pulmonar. Também se observou, nesse grupo, maior frequência de classes funcionais mais elevadas. O grupo com FEVE ≤ 40% apresentou menor gradiente valvar aórtico médio para área valvar equivalente. As taxas de sucesso do procedimento não diferiram entre os grupos. Não foram observadas diferenças na mortalidade, nos eventos coronarianos, cerebrovasculares, sangramentos, complicações vasculares e disfunção renal aguda no acompanhamento de 30 dias e 1 ano. No grupo FEVE ≤ 40%, a média da FEVE elevou-se de 31,5 para 45,1% 1 ano após o procedimento (p = 0,002).Conclusões: O TAVI em pacientes com EAo grave e FEVE ≤ 40% não aumenta o risco de complicações e estáassociado à melhora da FEVE.

Background: The increasing use of transcatheter aortic valve implantation (TAVI) in high-risk patients, especially those with ventricular dysfunction, justifies further evaluation of the selection and the results of the procedure. A database was used to characterize the profile of patients and evaluate TAVI results according to the degree of ventricular dysfunction.Methods: This was a longitudinal observational study that included all patients with severe aortic stenosis(AoS) submitted to TAVI between 2009 and 2014, comparing those with left ventricular ejection fraction (LVEF) ≤ 40% vs. > 40%. The safety and efficacy outcomes were evaluated at 30 days and 1 year. Results: Of the 172 patients, 20 (11.6%) had LVEF ≤ 40%. These patients were younger, with a higherprevalence of smoking, previous acute myocardial infarction, coronary artery bypass graft surgery, permanent pacemaker, and pulmonary artery hypertension. Higher functional classes were also more often observed in this group. The group with LVEF ≤ 40% had lower mean aortic valve gradient for anequivalent valve area. The procedure success did not differ between groups. There were no differences in mortality in coronary and cerebrovascular events, bleeding, vascular complications, and acute renal failure in the 30 day and 1 year follow-up. In the LVEF ≤ 40% group, the mean LVEF increased from 31.5 to 45.1% 1 year after the procedure (p = 0.002). Conclusions: TAVI in patients with severe AoS and LVEF ≤ 40% does not increase the risk of complications and is associated with LVEF improvement.

Costo-efectividad de reemplazo valvular aórtico percutáneo vs terapia conservadora en la estenosis aórtica de muy alto riesgo en un centro terciario chileno / Cost-effectiveness of trans aortic valve replacement vs. conservative treatment in high-risk patients with severe aortic stenosis in a referral hospital center in Santiago, Chile

Introducción: El objetivo fue evaluar la costo-efectividad del reemplazo valvular aórtico percutáneo (RVAP) contra terapia conservadora (TC) en pacientes con estenosis aórtica (EA) severa de muy alto riesgo, en un centro de derivación. Métodos: Los pacientes derivados entre Enero 2013 y Septiembre 2014, considerados de muy alto riesgo y candidatos a RVAP fueron incluidos. El costo de los recursos usados, de las readmisiones y la sobrevida fueron obtenidos para determinar el tiempo de vida ganado y la relación incremental de costo-efectividad (RICE) del RVAP Resultados: El grupo estudiado quedó compuesto por 39 pacientes, con edad promedio 82±7 años, más frecuentemente mujeres (74.4%), con elevado perfil de riesgo (STS score 11.4±5.6). Diecisiete pacientes (43.6%) fueron sometidos a RVAP y 22 (56.4%) a TC. Durante el seguimiento se registraron 25 rehospitalizaciones en el grupo de TC, a un costo promedio de $4.195.073 por paciente (7,027 dólares). Todos los pacientes sometidos a RAVP recibieron con éxito una prótesis Sapien XT y fueron egresados vivos. El costo promedio estimado del RVAP fue $20.000.000 (33,500 dólares). La sobrevida media fue de 54.5% (10 eventos) en grupo TC contra 94.1% (una muerte) en el grupo RVAP [285±204 días/seguimiento] (p<0.001). Así se pudo estimar que RVAP se asoció a un incremento de vida de al menos un año, lo cual resultó en una RICE de 26,470 dólares/año de vida ganado. Conclusión: El RAVP resultó costo-efectivo comparado con la TC en pacientes portadores de EA severa de muy alto riego tratados en la realidad de un centro de derivación nacional.

Aim: to evaluate cost-effectiveness of Transcatheter Aortic Valve Replacement (TAVR) compared to conservative treatment in patients with very high risk severe aortic stenosis (AS) referred to a tertiary center in Santiago, Chile Methods: Patients with high surgical risk and severe AS referred between January 2013 and September 2014 were included. Cost of resources, readdmissions, life-years gained and incremental cost-effectiveness of TAVI were calculated Results: Thirty-nine patients were finally included. Mean age was 82±7 years old, more commonly women (74%) with a mean STS score of 11.4±5.6 that confirmed their high-risk. Seventeen patients (43.6%) had TAVR and 22 (56.4%) underwent conventional medical therapy. All patients in the TAVR group - treated with Sapien XT® device - survived the procedure and were discharged alive. Mean cost of the procedure was approximately US$ 33,500. After a mean follow-up period of 285±204 days, mean survival rate in the control group was 54.5% (10 deaths) as compared to 94.1% in the TAVR group (1 death, p<0.001). Therefore, a gain of al least one year was obtained with TAVR resulting in an incremental cost effectiveness of US$ 26.470 per year of life gained. Conclusion: TAVR resulted costly-effective compared to conventional therapy in patients with severe AS and high surgical risk in a Chilean referral center.