Prognostic Role of TAPSE to PASP Ratio in Patients Undergoing MitraClip Procedure.

BACKGROUND: Transcatheter mitral valve repair (TMVR) is an effective therapy for high-risk patients with severe mitral regurgitation (MR) but heart failure (HF) readmissions and death remain substantial on mid-term follow-up. Recently, right ventricular (RV) to pulmonary arterial (PA) coupling has emerged as a relevant prognostic predictor in HF. In this study, we aimed to assess the prognostic value of tricuspid annular plane systolic excursion (TAPSE) to PA systolic pressure (PASP) ratio as a non-invasive measure of RV-to-PA coupling in patients undergoing TMVR with MitraClip (Abbott, CA, USA). METHODS: Multicentre registry including 228 consecutive patients that underwent successful TMVR with MitraClip. The sample was divided in two groups according to TAPSE/PASP median value: 0.35. The primary combined endpoint encompassed HF readmissions and all-cause mortality. RESULTS: Mean age was 72.5 ± 11.5 years and 154 (67.5%) patients were male. HF readmissions and all-cause mortality were more frequent in patients with TAPSE/PASP ≤ 0.35: Log-Rank 8.844, p = 0.003. On Cox regression, TAPSE/PASP emerged as a prognostic predictor of the primary combined endpoint, together with STS-Score. TAPSE/PASP was a better prognostic predictor than either TAPSE or PASP separately. CONCLUSIONS: TAPSE/PASP ratio appears as a novel prognostic predictor in patients undergoing MitraClip implantation that might improve risk stratification and candidate selection.

Reparación mitral transcatéter según la etiología de la insuficiencia mitral: datos de la vida real procedentes del registro español de MitraClip / Transcatheter mitral repair according to the cause of mitral regurgitation: real-life data from the Spanish MitraClip registry

INTRODUCCIÓN Y OBJETIVOS: La reparación de la válvula mitral transcatéter (RVMT) con el sistema MitraClip es un tratamiento para los pacientes con insuficiencia mitral (IM) grave de alto riesgo quirúrgico. El objetivo principal fue analizar los resultados del RVMT en pacientes con IM grave, según la etiología. MÉTODOS: Estudio observacional, prospectivo y multicéntrico con inclusión de pacientes consecutivos. El objetivo primario fue el combinado de mortalidad por todas las causas y reingresos hospitalarios por insuficiencia cardiaca al año. Se compararon las características clínicas y del procedimiento y los eventos para cada grupo de IM. Se realizó un análisis multivariable para determinar las variables asociadas con el objetivo primario. RESULTADOS: Se incluyó a 558 pacientes; 364 (65,2%) tenían etiología funcional; 111 (19,9%), degenerativa, y 83 (14,9%), mixta. La media de edad fue 72,8±11,1 años y eran varones el 70,3%. Respecto al objetivo primario, hubo 95 (17%) eventos en toda la serie. No hubo diferencias significativas entre los 3 grupos en el número de eventos del objetivo primario: 11 (11,3%) en la IM degenerativa, 71 (21,3%) en la funcional y 13 (18,1%) en la mixta (p = 0,101). Los predictores independientes fueron la clase funcional (p = 0,029), la revascularización quirúrgica previa (p = 0,031), el EuroSCORE II (p = 0,003), la diabetes mellitus (p = 0,037) y la fracción de eyección del ventrículo izquierdo (p = 0,015). CONCLUSIONES: Este trabajo confirma con datos de la práctica clínica la seguridad y la eficacia de la RVMT independientemente de la etiología de la IM y se documentan los principales factores asociados con el pronóstico durante el primer año de seguimiento

INTRODUCTION AND OBJECTIVES: Transcatheter mitral valve repair (TMVR) with MitraClip is a therapeutic option for high surgical risk patients with severe mitral regurgitation (MR). The main objective of this study was to analyze differences in outcomes in patients with severe MR according to the cause of MR. METHODS: Observational, multicenter, and prospective study with consecutive patient inclusion. The primary endpoint was the combination of all-cause mortality and new readmissions due to heart failure after 1 year. We compared clinical and procedural characteristics and the event rate for each MR group. We performed a multivariate analysis to identify predictive variables for the primary endpoint. RESULTS: A total of 558 patients were included: 364 (65.2%) with functional etiology, 111 (19.9%) degenerative and 83 (14.9%) mixed. The mean age was 72.8±11.1 years and 70.3% of the sample were men. There were 95 (17%) events in the overall sample. No significant differences were found in the 3 groups in the number of primary outcome events: 11 (11.3%) in degenerative MR, 71 (21.3%) in functional MR, and 13 (18.1%) in mixed MR (P=.101). Independent predictors were functional class (P=.029), previous surgical revascularization (P=.031), EuroSCORE II (P=.003), diabetes mellitus (P=.037), and left ventricular ejection fraction (P=.015). CONCLUSIONS: This study confirms the safety and efficacy of TMVR with MitraClip irrespective of MR etiology in real-life data and shows the main factors related to prognosis during the first year of follow up

Transcatheter mitral repair according to the cause of mitral regurgitation: real-life data from the Spanish MitraClip registry.

INTRODUCTION AND OBJECTIVES: Transcatheter mitral valve repair (TMVR) with MitraClip is a therapeutic option for high surgical risk patients with severe mitral regurgitation (MR). The main objective of this study was to analyze differences in outcomes in patients with severe MR according to the cause of MR. METHODS: Observational, multicenter, and prospective study with consecutive patient inclusion. The primary endpoint was the combination of all-cause mortality and new readmissions due to heart failure after 1 year. We compared clinical and procedural characteristics and the event rate for each MR group. We performed a multivariate analysis to identify predictive variables for the primary endpoint. RESULTS: A total of 558 patients were included: 364 (65.2%) with functional etiology, 111 (19.9%) degenerative and 83 (14.9%) mixed. The mean age was 72.8±11.1 years and 70.3% of the sample were men. There were 95 (17%) events in the overall sample. No significant differences were found in the 3 groups in the number of primary outcome events: 11 (11.3%) in degenerative MR, 71 (21.3%) in functional MR, and 13 (18.1%) in mixed MR (P=.101). Independent predictors were functional class (P=.029), previous surgical revascularization (P=.031), EuroSCORE II (P=.003), diabetes mellitus (P=.037), and left ventricular ejection fraction (P=.015). CONCLUSIONS: This study confirms the safety and efficacy of TMVR with MitraClip irrespective of MR etiology in real-life data and shows the main factors related to prognosis during the first year of follow up.

Registro Español de Hemodinámica y Cardiología Intervencionista. XXVI Informe Oficial de la Sección de Hemodinámica y Cardiología Intervencionista de la Sociedad Española de Cardiología (1990-2016) / Spanish Cardiac Catheterization and Coronary Intervention Registry. 26th Official Report of the Spanish Society of Cardiology Working Group on Cardiac Catheterization and Interventional Cardiology (1990-2016)

Introducción y objetivos: La Sección de Hemodinámica y Cardiología Intervencionista presenta su informe anual con los datos del registro de actividad correspondiente a 2016. Métodos: Todos los centros españoles con laboratorio de hemodinámica están invitados a aportar voluntariamente sus datos de actividad. La información se introduce online y una empresa independiente analiza la mayor parte. Resultados: En 2016 han participado en el registro nacional 106 centros, de los cuales 80 son públicos. Se realizaron 154.362 estudios diagnósticos; de ellos, 135.332 son coronariografías, un 14% más que años anteriores. La media española de diagnósticos totales por millón de habitantes fue de 3.322 (3.127 en 2015). El número de procedimientos intervencionistas coronarios fue un 7% superior al del año anterior: 68.695 (67.671 en 2015) y, aunque se registró una disminución en el tratamiento de la enfermedad multivaso del 3%, hubo un incremento del intervencionismo del tronco no protegido del 9,4%. Se implantaron en total 104.628 stents, entre ellos 88.344 farmacoactivos (el 84,4%, un 10% más que el año anterior) y 1.610 plataformas reabsorbibles. Se realizaron en total 20.588 procedimientos intervencionistas en el infarto agudo de miocardio (un crecimiento del 10% respecto a 2015), de los que el 83,7% fueron angioplastias primarias. Se utilizó el acceso radial en el 74,2% de los procedimientos diagnósticos, muy similar al año anterior, y el 82,6% de los intervencionistas (un 7% superior). El número de implantes transcatéter de prótesis valvular aórtica continúa incrementándose (aumento del 28%, n = 2.026), al igual que el número de procedimientos de reparación percutánea de la válvula mitral (MitraClip) (45%, n = 232) y cierres de orejuela: 496, lo que supone un incremento del 48,5% respecto a 2015. Conclusiones: En el año 2016 se registra un incremento de los procedimientos diagnósticos y terapéuticos en el seno del infarto. Sigue incrementándose el uso de abordaje radial y stents farmacoactivos en los procedimientos terapéuticos. El implante transcatéter de prótesis aórtica, la reparación con MitraClip y el cierre de orejuela izquierda continúan con el aumento progresivo observado en años anteriores (AU)

Introduction and objectives: The Working Group on Cardiac Catheterization and Interventional Cardiology presents its annual report on the activity data for 2016. Methods: All Spanish hospitals with catheterization laboratories were invited to voluntarily contribute their activity data. The information was collected online and was analyzed mainly by an independent company. Results: In 2016, 106 centers participated in the national registry; 80 of these centers are public. A total of 154 362 diagnostic studies were carried out, of which 135 332 were coronary angiograms. These figures are 14% higher than in previous years. The Spanish average of total diagnostic procedures per million population was 3322 (3.127 in 2015). The number of coronary interventional procedures was 7% higher than in the previous year: 68 695 (67 671 in 2015) and, although multivessel treatment decreased by 3%, unprotected left main trunk treatment increased by 9.4%. A total of 104 628 stents were implanted, of which 88 344 (84.4%) were drug-eluting stents (10% higher than in 2015) and 1610 were bioresorbable scaffolds. A total of 20 588 interventional procedures were performed in the acute myocardial infarction setting (10% increase), of which 83.7% were primary angioplasties. The radial approach was used in 74.2% of the diagnostic procedures, similar to the previous year, and in 82.6% of interventional procedures (7% increase). The number of transcatheter aortic valve implantations continued to increase (28% increase, n = 2026), as did the number of percutaneous mitral valve repair procedures (MitraClip) (45% increase, n = 232) and left atrial appendage closures (48.5% increase, n = 496). Conclusions: The number of diagnostic and therapeutic procedures in acute myocardial infarction increased in 2016. The use of the radial approach and drug-eluting stents also increased in therapeutic procedures. The growing trend observed in previous years continued for the use of transcatheter aortic prosthesis, the MitraClip device, and left atrial appendage closure (AU)

Spanish Cardiac Catheterization and Coronary Intervention Registry. 26th Official Report of the Spanish Society of Cardiology Working Group on Cardiac Catheterization and Interventional Cardiology (1990-2016).

INTRODUCTION AND OBJECTIVES: The Working Group on Cardiac Catheterization and Interventional Cardiology presents its annual report on the activity data for 2016. METHODS: All Spanish hospitals with catheterization laboratories were invited to voluntarily contribute their activity data. The information was collected online and was analyzed mainly by an independent company. RESULTS: In 2016, 106 centers participated in the national registry; 80 of these centers are public. A total of 154 362 diagnostic studies were carried out, of which 135 332 were coronary angiograms. These figures are 14% higher than in previous years. The Spanish average of total diagnostic procedures per million population was 3322 (3.127 in 2015). The number of coronary interventional procedures was 7% higher than in the previous year: 68 695 (67 671 in 2015) and, although multivessel treatment decreased by 3%, unprotected left main trunk treatment increased by 9.4%. A total of 104 628 stents were implanted, of which 88 344 (84.4%) were drug-eluting stents (10% higher than in 2015) and 1610 were bioresorbable scaffolds. A total of 20 588 interventional procedures were performed in the acute myocardial infarction setting (10% increase), of which 83.7% were primary angioplasties. The radial approach was used in 74.2% of the diagnostic procedures, similar to the previous year, and in 82.6% of interventional procedures (7% increase). The number of transcatheter aortic valve implantations continued to increase (28% increase, n = 2026), as did the number of percutaneous mitral valve repair procedures (MitraClip) (45% increase, n = 232) and left atrial appendage closures (48.5% increase, n = 496). CONCLUSIONS: The number of diagnostic and therapeutic procedures in acute myocardial infarction increased in 2016. The use of the radial approach and drug-eluting stents also increased in therapeutic procedures. The growing trend observed in previous years continued for the use of transcatheter aortic prosthesis, the MitraClip device, and left atrial appendage closure.

Experiencia inicial del tratamiento percutáneo de la regurgitación mitral con dispositivo MitraClip ® en España / Initial experience of percutaneoust treatment of mitral regurgitation with mitraClip ® therapy in Spain

Introducción y objetivos. La regurgitación mitral sintomática tiene un pronóstico desfavorable sin tratamiento quirúrgico. Sin embargo, según el registro europeo de enfermedad cardiaca valvular, no se intervino al 49% de los pacientes en esa situación. El tratamiento percutáneo de la regurgitación mitral con MitraClip® se ha demostrado seguro y eficaz añadido al tratamiento médico en este perfil de pacientes. El objetivo de este trabajo es describir la experiencia inicial con MitraClip® en España. Métodos. Estudio observacional retrospectivo que incluye a todos los pacientes tratados desde noviembre 2011 hasta julio 2013 por los cuatro hospitales españoles con mayor número de implantes. Resultados. Se trató a 62 pacientes (el 77,4% varones), principalmente con regurgitación mitral funcional restrictiva (85,4%), de gravedad grado III (37%) o IV (63%), fracción de eyección media del 36 ± 14% y clase funcional de la New York Heart Association III (37%) o IV (63%). En el 98% de los pacientes, se implantó con éxito el dispositivo. Al año, el 81,2% tenía regurgitación mitral ≤ 2 y el 90,9% en clase funcional de la New York Heart Association ≤ II. Hubo un solo caso de mortalidad periprocedimiento (sepsis 20 días después del implante) y otros 3 fallecimientos en el seguimiento (media, 9,1 meses). Fue necesario implantar un nuevo dispositivo por dehiscencia parcial del previo a 2 pacientes y se sometió a trasplante cardiaco a otros 2. Conclusiones. El tratamiento con MitraClip® en España se ha dirigido principalmente a pacientes con insuficiencia mitral funcional, disfunción ventricular sistólica significativa y elevado riesgo quirúrgico, y se perfila como una opción segura de tratamiento con capacidad de reducir la regurgitación mitral y mejorar la capacidad funcional (AU)

Introduction and objectives. Symptomatic mitral regurgitation has an unfavorable prognosis unless treated by surgery. However, the European registry of valvular heart disease reports that 49% of patients with this condition do not undergo surgery. Percutaneous treatment of mitral regurgitation with MitraClip® has been proved a safe, efficient adjunct to medical treatment in patients with this profile. The objective of the present study is to describe initial experience of MitraClip® therapy in Spain. Methods. Retrospective observational study including all patients treated between November 2011 and July 2013 at the 4 Spanish hospitals recording the highest numbers of implantations. Results. A total of 62 patients (77.4% men) were treated, mainly for restrictive functional mitral regurgitation (85.4%) of grade III (37%) or grade IV (63%), mean (standard deviation) ejection fraction 36% (14%), and New York Heart Association functional class III (37%) or IV (63%). Device implantation was successful in 98% of the patients. At 1 year, 81.2% had mitral regurgitation ≤ 2 and 90.9% were in New York Heart Association functional class ≤ II. One periprocedural death occurred (sepsis at 20 days post-implantation) and another 3 patients died during follow-up (mean, 9.1 months). Two patients needed a second implantation due to partial dehiscence of the first device and 2 others underwent heart transplantation. Conclusions. In Spain, MitraClip® therapy has principally been aimed at patients with functional mitral regurgitation, significant systolic ventricular dysfunction, and high surgical risk. It is considered a safe alternative treatment, which can reduce mitral regurgitation and improve functional capacity (AU)

Initial experience of percutaneous treatment of mitral regurgitation with MitraClip® therapy in Spain.

INTRODUCTION AND OBJECTIVES: Symptomatic mitral regurgitation has an unfavorable prognosis unless treated by surgery. However, the European registry of valvular heart disease reports that 49% of patients with this condition do not undergo surgery. Percutaneous treatment of mitral regurgitation with MitraClip® has been proved a safe, efficient adjunct to medical treatment in patients with this profile. The objective of the present study is to describe initial experience of MitraClip® therapy in Spain. METHODS: Retrospective observational study including all patients treated between November 2011 and July 2013 at the 4 Spanish hospitals recording the highest numbers of implantations. RESULTS: A total of 62 patients (77.4% men) were treated, mainly for restrictive functional mitral regurgitation (85.4%) of grade III (37%) or grade IV (63%), mean (standard deviation) ejection fraction 36% (14%), and New York Heart Association functional class III (37%) or IV (63%). Device implantation was successful in 98% of the patients. At 1 year, 81.2% had mitral regurgitation ≤ 2 and 90.9% were in New York Heart Association functional class ≤ II. One periprocedural death occurred (sepsis at 20 days post-implantation) and another 3 patients died during follow-up (mean, 9.1 months). Two patients needed a second implantation due to partial dehiscence of the first device and 2 others underwent heart transplantation. CONCLUSIONS: In Spain, MitraClip® therapy has principally been aimed at patients with functional mitral regurgitation, significant systolic ventricular dysfunction, and high surgical risk. It is considered a safe alternative treatment, which can reduce mitral regurgitation and improve functional capacity.