3D Virtual modelling, 3D printing and extended reality for planning of implant procedure of short-term and long-term mechanical circulatory support devices and heart transplantation.

Introduction: The use of three-dimensional (3D) reconstruction and printing technology, together with extended reality applied to advanced heart failure adult patients with complex anatomy, is rapidly spreading in clinical practice. We report practical experience with application to acute and chronic heart failure: planning and performing mechanical circulatory device insertion or heart transplantation. Methods: From November 2019 until February 2022, 53 3D virtual biomodels were produced for intervention planning (using Virtual/Augmented Reality and/or 3D printing), following a specific segmentation and preprocessing workflow for biomodelling, in patients with advanced heart failure due to structural heart disease or cardiomyopathies. Four of those patients were complex cases requiring mechanical circulatory support implant procedures in our center. Results: One short-term and three long-term ventricular assist device system were successfully clinically implanted after application of this technique. In other two cases with extremely high procedural risk, visualized after application of this multimodality imaging, heart transplantation was elected. Conclusion: 3D printing based planning and virtual procedure simulation, are of great importance to select appropriate candidates for mechanical circulatory support in case of complex patient anatomy and may help to diminish periprocedural complications. Extended reality represents a perspective tool in planification of complex surgical procedures or ventricular assist device insertion in this setting.

Early clinical and haemodynamic matched comparison of balloon-expandable valves.

OBJECTIVES: The balloon-expandable Sapien-3 valve demonstrated superior results in terms of residual aortic regurgitation when compared with self-expandable devices. We aimed to compare for the first-time early outcomes of Sapien-3 transcatheter heart valve (THV) with the balloon-expandable Myval device. METHODS: Consecutive real-world patients from nine European institutions with symptomatic severe aortic stenosis treated either with Sapien-3 or Myval THV devices after June 2018 were compared. Early clinical outcomes were prospectively gathered and blinded analysis of 30-day echocardiography was conducted. Matching for the following variables was performed: age, body surface area, Society of Thoracic Surgeons risk score, left ventricular function, mean gradient, transfemoral approach, aortic valvular calcium, aortic annulus mean diameter, area and eccentricity index. RESULTS: A total of 416 patients treated either with the Sapien-3 (n=286, 68.7%) or with Myval THV (n=130, 31.3%) were included and 103 pairs compared after matching. Baseline characteristics were similar. Procedural success rate (Sapien-3: 94.2%; Myval: 93.2%, p=0.219), 30-day mortality (Sapien-3: 2.9%; Myval: 0.97%, p=0.625), clinical efficacy (12.6 vs 4.9%, p=0.057) and early safety (12.6 vs 4.9%, p=0.096) were comparable. There was a lower need for new permanent pacemaker (15.5 vs 5.8% p=0.020) with Myval. No significant differences were found in terms of ≥moderate aortic regurgitation (1% for Sapien-3, 0% for Myval, p=0.314), but mean gradients were higher following Sapien-3 than after Myval (p<0.001). CONCLUSIONS: The new Myval balloon-expandable THV was favourable in terms of safety, with low rate of permanent pacemaker and with favourable residual gradients and paravalvular leak rate according to blinded echocardiographic analysis.

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.

Simulación impresa en 3D de intervención coronaria percutánea específica para un paciente / A 3D printed patient-specific simulator for percutaneous coronary intervention

No disponible

Síndrome de tako-tsubo complicado con taponamiento cardiaco y shock cardiogénico / Tako-tsubo cardiomyopathy complicated with cardiac tamponade and cardiogenic shock

No disponible

Prognostic impact of the SYNTAX score II in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention: analysis of a four-year all-comers registry.

AIMS: This study aimed to investigate the prognostic impact of the SYNTAX score II (SS-II) on ST-segment elevation myocardial infarction (STEMI) patients undergoing a primary percutaneous coronary intervention (pPCI). METHODS AND RESULTS: This retrospective cohort study included 1,689 patients with STEMI who underwent pPCI between January 2008 and December 2016. The patients were categorised into three groups based on SS-II tertiles (SS-II low tertile <24 [n=585], SS-II intermediate tertile ≥24 and ≤34 [n=567], and SS-II high tertile >34 [n=537]). In-hospital mortality was significantly lower in patients with low and mid SS-II when compared with high SS-II (0.7% vs 0.5% vs 16.4%, p=0.001). During follow-up (median 2.35 years), a high SS-II was positively correlated with MACE (12.3% for low SS-II vs 18.3% for mid SS-II vs 43.2% for high SS-II, p=0.001), all-cause mortality (1.5% vs 3.9% vs 14.2%, p=0.001) and heart failure (0.3% vs 2.7% vs 8.2%, p=0.001). The SS-II showed additive value on top of GRACE, anatomical SYNTAX score and residual SYNTAX score. CONCLUSIONS: The SS-II in patients with STEMI undergoing pPCI adds important prognostic information regarding midterm adverse outcomes, being an independent and powerful predictor of MACE, heart failure and all-cause mortality during follow-up.

Valor predictivo de la puntuación SYNTAX en la lesión vascular culpable y no culpable. Respuesta / Predictive value of the SYNTAX score in culprit and nonculprit vessel disease. Response

No disponible

Revascularización multivaso o solo de la lesión culpable en pacientes con infarto de miocardio con elevación del segmento ST: análisis de un registro a 8 años / Multivessel versus culprit-only percutaneous coronary intervention in st-segment elevation acute myocardial infarction: analysis of an 8-year registry

Introducción y objetivos: El tratamiento óptimo de los pacientes con enfermedad coronaria multivaso e infarto de miocardio con elevación del segmento ST (IAMCEST) tras una intervención coronaria percutánea (ICP) primaria es motivo de controversia. Con este trabajo se pretende analizar el impacto pronóstico de la ICP multivaso frente a ICP solo de la arteria origen del infarto en pacientes con IAMCEST y enfermedad multivaso en la práctica clínica real. Métodos: Estudio de cohortes retrospectivo que incluyó a 1.499 pacientes consecutivos con diagnóstico de IAMCEST sometidos a ICP primaria entre enero de 2008 y diciembre de 2015. El 40,8% (n = 611) tenía enfermedad coronaria multivaso. Se realizó un análisis mediante puntuación de propensión emparejada, con lo que se obtuvieron 2 grupos de 215 pacientes emparejados según se sometieran a ICP multivaso o solamente de la arteria culpable del infarto. Resultados: Durante el seguimiento (mediana, 2,36 años), tras emparejar por puntuación de propensión, los pacientes sometidos a ICP multivaso tuvieron menos mortalidad (el 5,1 frente al 11,6%; Peto-Peto p = 0,014), revascularización no planeada (el 7,0 frente al 12,6%; Peto-Peto p = 0,043) y eventos cardiovasculares adversos mayores (el 22,0 frente al 30,8%; Peto-Peto p = 0,049). Pese a que no resultó significativa, la tasa de reinfarto fue menor (el 4,2 frente al 6,1%; Peto-Peto p = 0,360). Conclusiones: La estrategia de realizar ICP multivaso en los pacientes con IAMCEST y enfermedad multivaso se asoció a una disminución de la mortalidad, la revascularización no planeada y los eventos cardiovasculares adversos mayores durante el seguimiento de una población de la práctica clínica real (AU)

Introduction and objectives: The optimal treatment of patients with multivessel coronary artery disease and ST-segment elevation acute myocardial infarction (STEMI) who undergo primary percutaneous coronary intervention (PCI) is controversial. The aim of this study was to access the prognostic impact of multivessel PCI vs culprit vessel-only PCI in real-world patients with STEMI and multivessel disease. Methods: This was a retrospective cohort study of 1499 patients with STEMI diagnosis who underwent primary PCI between January 2008 and December 2015. About 40.8% (n = 611) patients had multivessel disease. We performed a propensity score matched analysis to obtain 2 groups of 215 patients paired according to whether or not they had undergone multivessel PCI or culprit vessel-only PCI. Results: During follow-up (median, 2.36 years), after propensity score matching, patients who underwent multivessel PCI had lower rates of mortality (5.1% vs 11.6%; Peto-Peto P = .014), unplanned repeat revascularization (7.0% vs 12.6%; Peto-Peto P = .043) and major acute cardiovascular events (22.0% vs 30.8%; Peto-Peto P = .049). These patients also showed a trend to a lower incidence of myocardial infarction (4.2% vs 6.1%; Peto-Peto P = .360). Conclusions: In real-world patients presenting with STEMI and multivessel coronary artery disease, a multivessel PCI strategy was associated with lower rates of mortality, unplanned repeat revascularization, and major acute cardiovascular events (AU)

Asistencia ventricular percutánea Impella CP en la angioplastia de alto riesgo: experiencia inicial en España / Impella CP -assisted high-risk coronary percutaneous intervention: first experience in Spain

No disponible

Marcapasos transcatéter sin cables Micra. Resultados del implante y seguimiento a medio plazo en un centro / The micra leadless transcatheter pacemaker. implantation and mid-term follow-up results in a single center

Introducción y objetivos: Actualmente hay pocos estudios sobre el marcapasos sin cable (Micra) en la práctica clínica, especialmente con seguimientos > 6 meses. El objetivo es evaluar los parámetros eléctricos al implante y en el seguimiento, así como la seguridad de esta nueva técnica. Métodos: Estudio prospectivo y observacional en el que se incluyó a 30 pacientes consecutivos de edad ≥ 65 años con indicación de implante de marcapasos unicameral. Resultados: Se implantó exitosamente el Micra en los 30 pacientes incluidos. La media de edad era 79,4 ± 6,4 (66-89) años; 20 (66,6%) eran varones; 28 (93,3%) presentaban fibrilación auricular permanente; 1, taquicardia auricular y 1, ritmo sinusal. En 5 pacientes (16,6%) se realizó ablación del nódulo auriculoventricular en el mismo procedimiento (4 pacientes en fibrilación auricular rápida y 1 con taquicardia auricular); en 2 pacientes la indicación fue tras el implante percutáneo de válvula aórtica. En 23 (76,6%) el implante se realizó estando en tratamiento anticoagulante oral (INR máximo, 2,4). No hubo complicaciones mayores, salvo un derrame pericárdico moderado sin repercusión hemodinámica. El seguimiento medio fue de 5,3 ± 3,3 meses y 4 pacientes superaron el año de seguimiento. Los parámetros de estimulación fueron excelentes tanto en el implante como en el seguimiento a corto-medio plazo. Conclusiones: El implante de marcapasos sin cables es factible y seguro y presenta potenciales ventajas sobre los sistemas convencionales. Serán necesarios estudios con mayor seguimiento antes de generalizar su uso en la práctica clínica diaria (AU)

Introduction and objectives: Currently, studies on the leadless pacemaker (Micra) have mostly been limited to clinical trials with less than 6 months’ follow-up and they often fail to reflect real population outcomes. We sought to evaluate electrical parameters at implantation and chronologically during follow-up, as well as the safety of this new technique. Methods: This prospective, observational study included 30 consecutive patients, all ≥ 65 years, with an indication for single-chamber pacemaker implantation. Results: Successful implantation was accomplished in all patients referred for leadless implantation. The mean age was 79.4 ± 6.4 years (range, 66-89 years); 20 (66.6%) were men and 28 had permanent atrial fibrillation (93.3%); 1 had atrial tachycardia and 1 had sinus rhythm. Concomitant atrioventricular node ablation was performed immediately after implantation in 5 patients (16.6%), and implantation was performed after transcatheter aortic valve implantation in 2. The procedure was performed under an uninterrupted anticoagulation regimen (maximum INR 2.4) in 23 patients (76.6%). With the exception of 1 moderate pericardial effusion without tamponade, there were no severe complications. The mean follow-up was 5.3 ± 3.3 months and 4 patients had more than 1 year of follow-up. Sensing and pacing parameters were stable both at implantation and during the short- to mid-term follow-up. Conclusions Implantation of leadless pacemakers is feasible, safe and provides advantages over the conventional system. Further studies with longer follow-up periods will be needed before these devices become widely used in routine clinical practice (AU)

The Micra Leadless Transcatheter Pacemaker. Implantation and Mid-term Follow-up Results in a Single Center.

INTRODUCTION AND OBJECTIVES: Currently, studies on the leadless pacemaker (Micra) have mostly been limited to clinical trials with less than 6 months' follow-up and they often fail to reflect real population outcomes. We sought to evaluate electrical parameters at implantation and chronologically during follow-up, as well as the safety of this new technique. METHODS: This prospective, observational study included 30 consecutive patients, all ≥ 65 years, with an indication for single-chamber pacemaker implantation. RESULTS: Successful implantation was accomplished in all patients referred for leadless implantation. The mean age was 79.4±6.4 years (range, 66-89 years); 20 (66.6%) were men and 28 had permanent atrial fibrillation (93.3%); 1 had atrial tachycardia and 1 had sinus rhythm. Concomitant atrioventricular node ablation was performed immediately after implantation in 5 patients (16.6%), and implantation was performed after transcatheter aortic valve implantation in 2. The procedure was performed under an uninterrupted anticoagulation regimen (maximum INR 2.4) in 23 patients (76.6%). With the exception of 1 moderate pericardial effusion without tamponade, there were no severe complications. The mean follow-up was 5.3±3.3 months and 4 patients had more than 1 year of follow-up. Sensing and pacing parameters were stable both at implantation and during the short- to mid-term follow-up. CONCLUSIONS: Implantation of leadless pacemakers is feasible, safe and provides advantages over the conventional system. Further studies with longer follow-up periods will be needed before these devices become widely used in routine clinical practice.