Impacto de los inhibidores del sistema renina-angiotensina en el pronóstico tras recambio valvular aórtico quirúrgico o percutáneo. Metanálisis / Impact of renin-angiotensin system inhibitors on outcomes after surgical or transcatheter aortic valve replacement. A meta-analysis

Introducción y objetivos Determinar si la prescripción de inhibidores del sistema renina-angiotensina (iSRA) se asocia a mejores resultados tras implante percutáneo de válvula aórtica (TAVI) o recambio valvular aórtico quirúrgico (RVAQ). Métodos Se seleccionaron de PubMed, Web of Science, y Google Scholar hasta agosto de 2019 estudios comparativos de iSRA vs no-iSRA en pacientes sometidos a TAVI/RVAQ. Se extrajeron las hazard ratios (HR) con sus intervalos de confianza para mortalidad de cada estudio y estimadores específicos en el modelo de efectos aleatorios. Resultados Se incluyeron 6 estudios con un total de 21.390 pacientes (TAVI: 17.846, RVAQ: 3.544). Los 6 fueron estudios comparativos (3 análisis de propensión y 3 de cohortes) comparando iSRA vs no-iSRA. Se demostró que la prescripción de iSRA se asocia con una mortalidad significativamente menor en pacientes sometidos a intervención valvular aórtica (HR=0,64; IC95%, 0,47-0,88; p <0,001). Sin embargo, el análisis por subgrupos sugirió diferencias en función de la terapia seleccionada, con menor mortalidad en los sometidos a TAVI tratados con iSRA (HR=0,67; IC95%, 0,49-0,93) pero no en los tratados con RVAQ (HR=0,61; IC95%, 0,29-1,30). No se identificó asimetría en el análisis funnel plot, sugiriendo bajo riesgo de sesgo de publicación. El análisis de sensibilidad eliminando sucesivamente diferentes estudios no alteró de forma substancial el resultado. Conclusiones Estos resultados sugieren reducción de la mortalidad con la prescripción de iSRA en pacientes con estenosis aórtica sometidos a recambio valvular aórtico, en particular tras TAVI. Futuros estudios aleatorizados deberán confirmar o refutar este relevante hallazgo. (AU)

Introduction and objectives To determine whether renin-angiotensin system inhibitor (RASi) prescription is associated with better outcomes after transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR). Methods All comparative studies of RASi vs no RASi prescription in patients undergoing TAVI/SAVR were gathered from PubMed, Web of Science, and Google Scholar through August, 2019. We extracted hazard ratios (HRs) with their confidence intervals (CIs) for mortality from each study and combined study-specific estimates using inverse variance-weighted averages of logarithmic HRs in the random effects model. Results We identified 6 eligible studies with a total of 21 390 patients (TAVI: 17 846; SAVR: 3544) and included them in the present meta-analysis. The 6 studies were observational comparative studies (including 3 propensity score matched and 3 cohort studies) of RASi vs no RASi prescription. The analysis demonstrated that RASi prescription was associated with significantly lower mortality in the whole group of patients undergoing aortic valve intervention (HR, 0.64; 95%CI, 0.47-0.88; P <.001). However, subgroup analysis suggested differences according to the selected therapy, with TAVI showing better mortality rates in the RASi group (HR, 0.67; 95%CI, 0.49-0.93) but not in the SAVR group (HR, 0.61; 95%CI, 0.29-1.30). No funnel plot asymmetry was identified, suggesting minimum publication bias. Sensitivity analyses sequentially eliminating dissimilar studies did not substantially alter the primary result favoring RASI prescription. Conclusions These findings suggest a mortality benefit of RASi in patients with AS treated with aortic valve replacement that might be particularly relevant following TAVI. Future randomized studies are warranted to confirm this relevant finding. (AU)

Impact of renin-angiotensin system inhibitors on outcomes after surgical or transcatheter aortic valve replacement. A meta-analysis.

INTRODUCTION AND OBJECTIVES: To determine whether renin-angiotensin system inhibitor (RASi) prescription is associated with better outcomes after transcatheter aortic valve implantation (TAVI) and surgical aortic valve replacement (SAVR). METHODS: All comparative studies of RASi vs no RASi prescription in patients undergoing TAVI/SAVR were gathered from PubMed, Web of Science, and Google Scholar through August, 2019. We extracted hazard ratios (HRs) with their confidence intervals (CIs) for mortality from each study and combined study-specific estimates using inverse variance-weighted averages of logarithmic HRs in the random effects model. RESULTS: We identified 6 eligible studies with a total of 21 390 patients (TAVI: 17 846; SAVR: 3544) and included them in the present meta-analysis. The 6 studies were observational comparative studies (including 3 propensity score matched and 3 cohort studies) of RASi vs no RASi prescription. The analysis demonstrated that RASi prescription was associated with significantly lower mortality in the whole group of patients undergoing aortic valve intervention (HR, 0.64; 95%CI, 0.47-0.88; P <.001). However, subgroup analysis suggested differences according to the selected therapy, with TAVI showing better mortality rates in the RASi group (HR, 0.67; 95%CI, 0.49-0.93) but not in the SAVR group (HR, 0.61; 95%CI, 0.29-1.30). No funnel plot asymmetry was identified, suggesting minimum publication bias. Sensitivity analyses sequentially eliminating dissimilar studies did not substantially alter the primary result favoring RASI prescription. CONCLUSIONS: These findings suggest a mortality benefit of RASi in patients with AS treated with aortic valve replacement that might be particularly relevant following TAVI. Future randomized studies are warranted to confirm this relevant finding.

Resultados clínicos actuales en insuficiencia tricúspide y experiencia inicial con el sistema TricValve en España / Current clinical outcomes of tricuspid regurgitation and initial experience with the TricValve system in Spain

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Redes asistenciales para el tratamiento del shock cardiogénico. Código shock. ¿Dónde y cómo implementarlo? / Critical care networks for the treatment of cardiogenic shock. Where and how should the shock code be implemented?

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Comparison of Figulla Flex® and Amplatzer™ devices for atrial septal defect closure: A meta-analysis.

BACKGROUND: Atrial septal defect (ASD) is one of the most common congenital heart diseases. Percutaneous closure is the preferred treatment, but certain complications remain a concern. The most common devices are AMPLATZER™ (ASO) (St. Jude Medical, St. Paul, MN, USA) and Figulla Flex® septal occluders (FSO) (Occlutech GmbH, Jena, Germany). The present study aimed to assess main differences in outcomes. METHODS: A systematic search in Pubmed and Google scholarship was performed by two independent reviewers for any study comparing ASO and FSO. Searched terms were "Figulla", "Amplatzer", and "atrial septal defect". A random-effects model was used. RESULTS: A total of 11 studies including 1770 patients (897 ASO; 873 FSO) were gathered. Baseline clinical and echocardiographic characteristics were comparable although septal aneurysm was more often reported in patients treated with ASO (32% vs. 25%; p = 0.061). Success rate (94% vs. 95%; OR: 0.81; 95% CI: 0.38-1.71; p = 0.58) and peri-procedural complications were comparable. Procedures were shorter, requiring less fluoroscopy time with an FSO device (OR: 0.59; 95% CI: 0.20-0.97; p = 0.003). Although the global rate of complications in long-term was similar, the ASO device was associated with a higher rate of supraventricular arrhythmias (14.7% vs. 7.8%, p = 0.009). CONCLUSIONS: Percutaneous closure of ASD is a safe and effective, irrespective of the type of device. No differences exist regarding procedural success between the ASO and FSO devices but the last was associated to shorter procedure time, less radiation, and lower rate of supraventricular arrhythmias in follow-up. Late cardiac perforation did not occur and death in the follow-up was exceptional.

El Multivalvular Score para predecir la evolución de la insuficiencia mitral en pacientes con estenosis aórtica tratados con TAVI: validación prospectiva / The multivalvular score for predicting the outcome of mitral regurgitation in aortic stenosis patients treated with TAVI: prospective validation

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Recuperación estructural y funcional tras 5 años del implante de armazón vascular bioabsorbible. Un análisis con tomografía de coherencia óptica / Functional and structural coronary recovery at the 5-year follow-up after bioresorbable vascular scaffold implantation. An optical coherence tomography analysis

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Comparación de la hemodinámica valvular de la prótesis transcatéter con balón expandible SAPIEN 3 frente a la autoexpandible Evolut R: estudio de casos emparejados / Comparison of the hemodynamic performance of the balloon-expandable SAPIEN 3 versus self-expandable evolut R transcatheter valve: a case-matched study

Introducción y objetivos: Las válvulas SAPIEN 3 (S3) y Medtronic Evolut R (EVR) son prótesis transcatéter de segunda generación, diseñadas para reducir el grado de insuficiencia aórtica (IAo) paravalvular. El objetivo es comparar la hemodinámica valvular en un estudio de casos emparejados con análisis ecocardiográfico independiente. Métodos: De una población de 201 pacientes tratados con implante percutáneo de válvula aórtica, se emparejó a un total de 144 (S3, n = 80; EVR, n = 64) en función del diámetro del anillo y de la puntuación de calcio aórtico medidos por tomografía computarizada. Los ecocardiogramas de seguimiento basal, al mes y a los 6 meses se analizaron de manera independiente y centralizada. Resultados: No se observaron diferencias respecto a las características basales clínicas y ecocardiográficas. La prótesis EVR mostró un mejor perfil hemodinámico evaluado mediante gradiente aórtico máximo (EVR frente a S3, 13 ± 7 frente a 20 ± 10; p < 0,001), gradiente aórtico medio (7 ± 3 frente a 11 ± 6; p < 0,001) e índice de velocidad Doppler (0,65 ± 0,15 frente a 0,51 ± 0,16; p < 0,001). Por otro lado, la tasa de IAo paravalvular moderada-grave o de cualquier grado de IAo paravalvular (≥ leve) fue mayor en el grupo de EVR (el 11 y el 50%) que en el de S3 (el 2,5 y el 21%; p < 0,05), con mayor número de chorros regurgitantes (p < 0,001). Conclusiones: En una cohorte de casos emparejados tratados con implante percutáneo de válvula aórtica de segunda generación, la S3 se asoció con una menor tasa de IAo paravalvular y mayor gradiente transprotésico residual que con la EVR

Introduction and objectives: The SAPIEN 3 (S3) valve and the Medtronic Evolut R (EVR) are second-generation transcatheter valves, designed to further reduce the rate of paravalvular aortic regurgitation (AoR). The aim of this study was to compare the 2 devices in terms of valve performance in a case-matched study with independent echocardiographic analysis. Methods: Of a population of 201 patients who underwent transcatheter aortic valve implantation, 144 patients (S3, n = 80; EVR, n = 64) were matched according to aortic annulus diameter and aortic valve calcium score, as assessed by computed tomography. All echocardiographic examinations collected at baseline and at 1- and 6-month follow-up were centrally analyzed. Results: The 2 groups were well balanced in baseline clinical and echocardiographic characteristics. The EVR valve showed a better hemodynamic profile as assessed by peak aortic gradient (EVR 13 ± 7 vs S3 20 ± 10 mmHg; P < .001), mean aortic gradient (EVR 7 ± 3 vs S3 11 ± 6 mmHg; P < .001), and Doppler velocity index (EVR 0.65 ± 0.15 vs S3 0.51 ± 0.16; P < .001). The rate of moderate-severe or any paravalvular (≥ mild) AoR was higher in the EVR group (11% and 50%) than in the S3 group (2.5% and 21%; P < .05, respectively), with a larger number of paravalvular jets (P < .001). Conclusions: In a case-matched cohort of transcatheter aortic valve implantation patients, the S3 valve was associated with a lower rate of paravalvular AoR but also with a higher residual gradient than the EVR system

La insuficiencia tricúspide, y no la insuficiencia mitral, determina la mortalidad en pacientes que presentan insuficiencia mitral no grave previa a TAVI / Tricuspid but not mitral regurgitation determines mortality after TAVI in patients with nonsevere mitral regurgitation

Introducción y objetivos: Muchos pacientes sometidos a implante percutáneo de válvula aórtica (TAVI) presentan insuficiencia mitral (IM) de grado moderado o menor. El impacto de la insuficiencia tricuspídea (IT) sigue sin resolverse. Se analiza el impacto de la IM moderada frente a leve-ausente y su evolución, y de la IT concomitante y su interacción con la IM. Métodos: Estudio retrospectivo multicéntrico de 813 pacientes tratados con TAVI entre 2007 y 2015 con IM ≤ 2 y abordaje transfemoral. Resultados: La edad media fue 81 ± 7 años y el Society of Thoracic Surgeons-score fue de 6,9 ± 5,1%. El 37,3% presentó IM moderada, con resultados comparables intrahospitalarios y de mortalidad a 6 meses frente a IM < 2 (11,9 frente a 9,4%; p = 0,257). Sin embargo, experimentaron más rehospitalizaciones y peor clase de la New York Heart Association (p = 0,008 y 0,001, respectivamente). Solo un 3,8% demostró un aumento en el grado de IM > 2 tras el TAVI. La presencia de IT moderada/grave se asoció con una mortalidad intrahospitalaria y de seguimiento del 13 y el 34,1%, independientemente del grado de IM. La IT moderada-grave fue predictor independiente de mortalidad (HR = 18,4; IC95%, 10,2-33,3; p < 0,001). Conclusiones: La presencia de IM moderada no supuso mayor mortalidad a corto-medio plazo tras el TAVI, pero asoció más rehospitalizaciones. La presencia de IT moderada/grave implicó mayor mortalidad. Esto sugiere que una evaluación minuciosa de los mecanismos subyacentes entre ambas insuficiencias valvulares debe realizarse para determinar la mejor estrategia para evitar la futilidad relacionada con TAVI

Introduction and objectives: Many patients undergoing transcatheter aortic valve implantation (TAVI) have concomitant mitral regurgitation (MR) of moderate grade or less. The impact of coexistent tricuspid regurgitation (TR) remains to be determined. We sought to analyze the impact of moderate vs none-to-mild MR and its trend after TAVI, as well as the impact of concomitant TR and its interaction with MR. Methods: Multicenter retrospective study of 813 TAVI patients treated through the transfemoral approach with MR ≤ 2 between 2007 and 2015. Results: The mean age was 81 ± 7 years and the mean Society of Thoracic Surgeons score was 6.9% ± 5.1%. Moderate MR was present in 37.3% of the patients, with similar in-hospital outcomes and 6-month follow-up mortality to those with MR < 2 (11.9% vs 9.4%; P = .257). However, they experienced more rehospitalizations and worse New York Heart Association class (P = .008 and .001, respectively). Few patients (3.8%) showed an increase in the MR grade to > 2 post-TAVI. The presence of concomitant moderate/severe TR was associated with in-hospital and follow-up mortality rates of 13% and 34.1%, respectively, regardless of MR grade. Moderate-severe TR was independently associated with mortality (HR, 18.4; 95%CI, 10.2-33.3; P < .001). Conclusions: The presence of moderate MR seemed not to impact short- and mid-term mortality post-TAVI, but was associated with more rehospitalizations. The presence of moderate or severe TR was associated with higher mortality. This suggests that a thorough evaluation of the mechanisms underlying concomitant mitral and tricuspid valve regurgitation should be performed to determine the best strategy for avoiding TAVI-related futility

Effect of direct intramyocardial autologous stem cell grafting in the sub-acute phase after myocardial infarction.

BACKGROUND: To assess the efficacy and safety of intramyocardial autologous bone marrow mononuclear stem cells (BMMNC) grafting combined with coronary artery bypass grafting (CABG) on ventricular remodeling and global and regional wall motion after acute transmural myocardial infarction (AMI). METHODS: Randomized controlled trial including 20 patients with non-revascularized transmural AMI, left ventricular ejection fraction (LVEF) lower than 50% and surgical indication for CABG. The stem cell group was treated with BMMNC grafting by direct intramyocardial injection between the 10th and 15th days after AMI (subacute phase) combined with CABG under cardiopulmonary bypass; the control group was only treated with CABG. Magnetic resonance imaging with gadolinium and stress echocardiography were performed presurgery and 9 months postsurgery. RESULTS: Seventeen patients completed the follow-up. The baseline characteristics of both groups were homogeneous. No significant differences were found in the increase in LVEF (control: 6.99±4.60, cells: 7.47±6.61, P=0.876) or in the decrease in global (control: 0.28±0.39, cells: 0.22±0.28, P=0.759) or regional (control: 0.52±0.38, cells: 0.74±0.60, P=0.415) wall motion indices between the control and stem cell groups of AMI patients. No differences were found in the recovered non-viable segments (control: 1.29±1.11, cells: 2.50±1.41, P=0.091) or in the decrease in end-diastolic (control: 14.05±19.72, cells: 18.40±29.89, P=0.725) or end-systolic (control: 15.42±13.93, cells: 23.06±25.03, P=0.442) volumes. No complications from stem cell grafting were observed. CONCLUSIONS: The results from our study reported herein suggest that intramyocardial BMMNC administration during CABG in patients with AMI causes no medium- to long-term improvement in ventricular remodeling.

Transubclavian approach: A competitive access for transcatheter aortic valve implantation as compared to transfemoral.

AIMS: Empirically, transfemoral (TF) approach is the first choice for transcatheter aortic valve implantation (TAVI). We aimed to investigate whether transubclavian (TSc) and TF approaches present comparable major outcomes according to current evidence. METHODS: We systematically searched PubMed, EMBASE, and Cochrane database for studies with symptomatic aortic stenosis patients who underwent TAVI through TF or TSc/axillary access from January/2006 to January/2017. Searched terms were: ("aortic stenosis" OR "transcatheter aortic" OR "TAVI" OR "TAVR") and ("transfemoral" OR "transaxillary" OR "transubclavian"). Major outcomes according to Valve Academic Research Consortium-2 criteria were gathered. The odds ratio (OR) was used as a summary statistic. A random-effects model was used. A fully percutaneous TSc TAVI case from our institution illustrates minimalist approach. RESULTS: Final analysis was made with six studies including 4,504 patients (3,886 TF and 618 TSc). Baseline characteristics of compared groups in individual studies were similar, with the exception of a higher logistic EuroSCORE in the TSc group (23.7 ± 1.92 vs. 21.17 ± 3.51, P = 0.04) and higher prevalence of coronary and peripheral artery disease with OR = 0.67 [95% CI: 0.54-0.83] (P = 0.0003) and OR = 0.08 [95% CI: 0.05-0.12] (P < 0.00001), respectively. TSc group presented comparable 30-day mortality (OR = 1.37; [95%CI: 0.85-2.21]; P = 0.20). There were no differences for procedural success, 30-day stroke rate, need for new pacemaker implantation, major vascular complications, and acute kidney injury requiring dialysis. Also, no differences were found concerning 1-year mortality. CONCLUSIONS: Our study suggests that TSc approach may be, not only an alternative route to TF approach for TAVI, but even a competitive one in certain patients with increased risk of femoral injury.

Intracardiac shunts following transcatheter aortic valve implantation: a multicentre study.

AIMS: The aim of this study was to describe the incidence, mechanisms, management and outcomes of intracardiac shunts (ICS) following TAVI. METHODS AND RESULTS: This was a multicentre registry across 10 centres aimed at gathering all cases of ICS (1.1%) including infection-related (IRICS, 0.3%) or aseptic (AICS, 0.8%) shunts. Patients presented porcelain aorta (24% vs. 6.8%, p=0.024) and had been treated with predilation (88% vs. 68.5%, p=0.037) or post-dilation (59.1% vs. 19.3%, p<0.001) more often. Median time from intervention to diagnosis of ICS was 10 days (IQR: 2-108), being longer for IRICS (171 [63-249] vs. 3 [1-12] days, p=0.002). Interventricular septum (55.6%) and anterior mitral leaflet (57.2%) were the most common locations for AICS and IRICS, respectively. Most patients (76%) developed heart failure but 64% were medically managed. Seven patients (38.9%) underwent percutaneous closure of AICS. The in-hospital mortality rate was 44% (IRICS 100%, AICS 27.8%) compared to global TAVI recipients (8.1%, p<0.001). At one-year follow-up, 76% of the patients had died. ICS, logistic EuroSCORE, and moderate-severe residual aortic regurgitation were independent predictors of death. CONCLUSIONS: Post-TAVI ICS are an uncommon complication independently associated with high early mortality. Currently, most therapeutic alternatives yield poor results but percutaneous closure of AICS was feasible and is a promising alternative.