Comparative analysis of different risk prediction tools after mitral Transcatheter edge-to-edge repair.

BACKGROUND: Transcatheter edge-to-edge repair (TEER) has become an established treatment for primary and secondary mitral regurgitation (PMR and SMR). The objective of this study was to compare the accuracy of different risk scores for predicting 1-year mortality and the composite endpoint of 1-year mortality and/or heart failure (HF) hospitalization after TEER. METHODS: We analyzed data from 206 patients treated for MR at a tertiary European center between 2011 and 2023 and compared the accuracy of different mitral and surgical risk scores: EuroSCORE II, GRASP, MITRALITY, MitraScore, TAPSE/PASP-MitraScore, and STS for predicting 1-year mortality and the composite of 1-year mortality and/or HF hospitalization in PMR and SMR. A subanalysis of SMR-only patients with the addition of COAPT Risk Score and baseline N-Terminal pro-Brain Natriuretic Peptide (NT-proBNP) list was also performed. RESULTS: MITRALITY had the best discriminative ability for 1-year mortality and the composite endpoint of 1-year mortality and/or HF hospitalization, with an area under the curve (AUC) of 0.74 and 0.74, respectively, in a composed group of PMR and SMR. In a SMR-only population, MITRALITY also presented the best AUC for 1-year mortality and the composite endpoint of 1-year mortality and/or HF hospitalization, with values of 0.72 and 0.72, respectively. CONCLUSION: MITRALITY was the best mitral TEER risk model for both 1-year mortality and the composite endpoint of 1-year mortality and/or HF hospitalization in a population of PMR and SMR patients, as well as in SMR patients only. Surgical risk scores, MitraScore, TAPSE/PASP-MitraScore and NT-proBNP alone showed poor predictive values.

Reparación percutánea de insuficiencia mitral primaria con técnica borde a borde: primer reporte de caso en Uruguay / Percutaneous edge-to-edge repair of primary mitral regurgitation: first case report in Uruguay / Correção percutânea de regurgitação mitral primária com técnica "edge-to-edge": primeiro caso reportado em Uruguai

La insuficiencia mitral (IM) es una enfermedad frecuente. La degeneración mixomatosa es la principal causa de IM primaria en los países desarrollados. Si no se corrige, conduce a la disfunción ventricular y a la insuficiencia cardíaca congestiva, con elevada morbimortalidad. La cirugía de reparación valvular es el tratamiento recomendado en la IM primaria severa y sintomática. En los pacientes con alto riesgo quirúrgico las opciones terapéuticas son limitadas. El surgimiento de la reparación percutánea borde a borde ha permitido ofrecer alternativas terapéuticas para estos pacientes, y se han demostrado buenos resultados. Se presenta el caso clínico de un paciente añoso con IM primaria severa. Por su elevado riesgo quirúrgico se optó por realizar reparación percutánea con técnica borde a borde, con excelentes resultados clínicos y ecocardiográficos. Se trata del primer reporte de caso de estas características en nuestro país.

Mitral regurgitation (MR) is a common disease. Myxomatous degeneration is the main cause of primary MR in developed countries. If not corrected, it leads to ventricular dysfunction and congestive heart failure, with high morbidity and mortality. Valve repair surgery is the recommended treatment for severe and symptomatic primary MR. In patients with high surgical risk, therapeutic options are limited. The emergence of edge-to-edge percutaneous repair has made it possible to offer therapeutic alternatives for these patients, and good results have been demonstrated. We present the clinical case of an elderly patient with severe primary MR. Due to his high surgical risk, it was decided to perform percutaneous repair with edge-to-edge technique, with excellent clinical and echocardiographic results. It is the first case report of these characteristics in our country.

A regurgitação mitral (RM) é uma doença frequente. A degeneração mixomatosa é a principal causa de RM primária em países desenvolvidos. Se não for corrigido, leva à disfunção ventricular e insuficiência cardíaca congestiva, com alta morbimortalidade. A cirurgia de reparo valvular é o tratamento recomendado na RM primária grave. Em pacientes com alto risco cirúrgico, as opções terapêuticas são limitadas. O surgimento do reparo percutâneo com plicatura dos segmentos é uma opção terapêutica alternativa, com bons resultados demonstrados. Apresentamos o caso clínico de um paciente doente por RM primária grave. Devido ao seu alto risco cirúrgico, optou-se pela correção percutânea com técnica "edge-to-edge", com excelentes resultados clínicos e ecocardiográficos. Este é o primeiro caso publicado com a técnica em Uruguai.

Cerebrovascular Events After Transcatheter Edge-to-Edge Repair and Guideline-Directed Medical Therapy in the COAPT Trial.

BACKGROUND: Little is known regarding the risk of cerebrovascular events (CVE) in patients with heart failure and severe secondary mitral regurgitation treated with transcatheter edge-to-edge repair (TEER). OBJECTIVES: The study sought to examine the incidence, predictors, timing, and prognostic impact of CVE (stroke or transient ischemic attack) in the COAPT (Cardiovascular Outcomes Assessment of the Mitraclip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation) trial. METHODS: A total of 614 patients with heart failure and severe secondary mitral regurgitation were randomized to TEER plus guideline-directed medical therapy (GDMT) vs GDMT alone. RESULTS: At 4-year follow-up, 50 CVEs occurred in 48 (7.8%) of the 614 total patients enrolled in the COAPT trial; Kaplan-Meier event rates were 12.3% in the TEER group and 10.2 in the GDMT alone group (P = 0.91). Within 30 days of randomization, CVE occurred in 2 (0.7%) patients randomized to TEER and 0% randomized to GDMT (P = 0.15). Baseline renal dysfunction and diabetes were independently associated with increased risk of CVE, while baseline anticoagulation was associated with a reduction of CVE. A significant interaction was present between treatment group and anticoagulation such that TEER compared with GDMT alone was associated with a reduced risk of CVE among patients with anticoagulation (adjusted HR: 0.24; 95% CI: 0.08-0.73) compared with an increased risk of CVE in patients without anticoagulation (adjusted HR: 2.27; 95% CI: 1.08-4.81; Pinteraction = 0.001). CVE was an independent predictor of death within 30 days after the event (HR: 14.37; 95% CI: 7.61, 27.14; P < 0.0001). CONCLUSIONS: In the COAPT trial, the 4-year rate of CVE was similar after TEER or GDMT alone. CVE was strongly associated with mortality. Whether anticoagulation is effective at reducing CVE risk after TEER warrants further study. (Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients With Functional Mitral Regurgitation [The COAPT Trial] and COAPT CAS [COAPT); NCT01626079).

Reparación valvular mitral por cateterismo: experiencia inicial con MitraClip® / Percutaneous Mitral Valve Repair: Initial Experience with MitraClip™

RESUMEN Objetivos: Reportar y analizar los resultados iniciales de una serie de pacientes con insuficiencia mitral (IM) grave sintomática y alto riesgo para cirugía que recibieron reparación percutánea de la válvula mitral (RPVM) con MitraClip®. Material y métodos: Entre marzo de 2016 y octubre de 2018 recibieron RPVM con MitraClip® en forma consecutiva 12 sujetos con IM grave sintomática, con alto riesgo o contraindicación para cirugía. Se consideró "éxito del implante" (EI) el correcto agarre de las valvas con el clip que dejó una IM residual leve o moderada al finalizar el procedimiento, y "éxito del procedimiento (EP) a 30 días" el EI en ausencia de eventos adversos mayores (MACE), los que incluyeron muerte, infarto agudo de miocardio (IAM), accidente cerebrovascular (ACV), necesidad de cirugía valvular, derrame pericárdico, taponamiento o sangrado mayor. Datos basales y antecedentes de los pacientes: la media de edad fue de 74,1 ± 8,9 años; 7 eran hombres; 3, diabéticos; 10 eran hipertensos y dislipidémicos; 4 eran tabaquistas, 5 tenían fibrilación auricular, 2 portaban marcapasos definitivo, 3 documentaban IAM previo, 2 habían sido sometidos antes a ATC y 4 a cirugía cardíaca. La tasa de filtración glomerular estimada (eGFR) fue de 73,8 ± 34,8 ml/m2, 2 tenían < 60 ml/m2 y uno se encontraba en diálisis. Todos los pacientes estaban en clase funcional (CF) III-IV, con antecedentes de internaciones por insuficiencia cardíaca (IC). Características ecográficas: diámetro diastólico del ventrículo izquierdo (DDVI): 61,8 ± 6,4 mm; diámetro sistólico (DSVI): 46,3±2,1 mm; fracción de eyección del ventrículo izquierdo (FEVI): 47,5±13,4% (rango: 25-60%). La causa de la IM era degenerativa en 7 pacientes y funcional en 5. La evaluación del riesgo mostró un EuroSCORElog de 9,6±6,8; el STS score de mortalidad fue 16,1 ±1 3,5 y el de morbimortalidad 22,8 ± 17,7. Resultados: Se obtuvo EI en todos los pacientes; en 7 enfermos se implantó 1 solo clip y en los otros 5 se colocaron 2 clips; el gradiente residual medio posimplante fue 3,6 ± 0,2 mmHg. La IM posprocedimiento fue leve en 11 y mínima en 1. La estadía hospitalaria media fue de 1,9 ± 0,8 días (rango: 1-3 días). A los 30 días, todos los sujetos se encontraban en CF I-II; ningún paciente presentó eventos mayores o reinternación por IC. El seguimiento abarcó a todos los pacientes y se extendió por un tiempo medio de 8,8 ± 6,7 meses (rango: 1-30 meses). Dos pacientes fallecieron: 1 de neumonía a los 14 meses y otro a los 30 meses por IC refractaria luego de un reemplazo valvular aórtico por cateterismo (TAVI), manteniendo IM leve. No hubo otras complicaciones. Todos se encontraban en CF I-II, 1 requirió reinternación por IC (a los 7 meses). El eco-Doppler cardíaco de seguimiento demostró IM leve en 11 pacientes y moderada a grave en 1. Hubo una mejoría en la calidad de vida en todos los casos. Conclusiones: En esta serie inicial de un solo centro y que incluye la curva de aprendizaje, la RPVM con MitraClip® en pacientes con IM grave sintomática y alto riesgo quirúrgico fue segura y efectiva, con una mejoría clínica significativa y también en la calidad de vida en el seguimiento.

ABSTRACT Objective: To analyze and report our initial outcomes of Percutaneous Mitral Valve Repair (PMVR) with MitraClip® for patients with severe symptomatic Mitral Regurgitation (MR) and high surgical risk. Methods: Between March 2016 and October 2018 twelve consecutive PMVR with MitraClip® were performed in patients with severe symptomatic MR and contraindication or high surgical risk. Implantation Success (IS) was defined as adequate leaflets grasping, leaving < moderate residual MR at the end of the procedure and 30-day Procedural Success when IS was achieved without any Major Adverse Cardiovascular Event (MACE: death, AMI, Stroke, need of valvular surgery, pericardial effusion, tamponade or major bleeding). Results: Mean age was 74.1±8.9 years, all of them had hypertension and Dyslipemia 7 were men, 3 diabetics, 4 smokers, 5 had previous atrial fibrillation, 2 permanent pacemakers, 3 previous AMI, 2 of them had received PCI and 4 cardiac surgery. The eGFR was 73.8±34.8 ml/m2, 2 had <60 ml/m2 and one on dialysis. All Ptes were in FC III-IV and history of previous hospitalizations because heart failure. Echocardiographic findings: Left Ventricle End Diastolic Diameter (LVEDD) 61.8±6.4, End Systolic Diameter (LVESD) 46.3±2.1; left ventricular ejection fraction (LVEF) 47.5±13.4 (25-60). MI were degenerative in 7 Ptes and functional in 5. Risk Scores: EuroSCORE log was 9.6±6.8, STS for mortality 16.1±13.5 and the STS for morbimortality of 22.8±17.7 EI was achieved in all Ptes; 1 Single Clip was implanted in 7 Pts and 2 Clips in 5; Mean residual post-implantation gradient was 3.6±0.2 mmHg. IS was achieved in all; post-procedural MR was mild in 11 and trivial in one. Mean length of hospital stay was 1.9±0.8 (1-3) days. At 30 days all were in FC 0-II, no one presented MACE or rehospitalization because heart failure. Follow-Up was performed in all Ptes with an average time of 8.8±6.7 (1-30) months. Two patients died (1 from pneumonia at 14 months and another at 30 months due to refractory cardiac failure after TAVI, maintaining mild MR.) There were no other complications, all were in FC I-II, one required rehospitalization due to heart failure (at 7 month). Echo Doppler at follow-Up showed that 11 Ptes had <2 MR and 1 had >2 MR. The QOL improved during the follow-up Conclusion: In this initial series, from a single center that includes the learning curve of the team, PMVR with MitraClip® in Ptes with severe mitral regurgitation and high surgical risk was safe and effective, with a significant clinical improvement at follow-up

Extended use of percutaneous edge-to-edge mitral valve repair beyond EVEREST (Endovascular Valve Edge-to-Edge Repair) criteria: 30-day and 12-month clinical and echocardiographic outcomes from the GRASP (Getting Reduction of Mitral Insufficiency by Percutaneous Clip Implantation) registry.

OBJECTIVES: This study sought to compare, in high-risk patients with 3+ to 4+ mitral regurgitation (MR) dichotomized by baseline echocardiographic features, acute, 30-day, and 12-month outcomes following percutaneous mitral valve repair using the MitraClip. BACKGROUND: The feasibility and mid-term outcomes after MitraClip implantation in patients with echocardiographic features different from the EVEREST (Endovascular Valve Edge-to-Edge Repair) I and II trials have been scarcely studied. METHODS: Clinical and echocardiographic outcomes through 12-month follow-up of consecutive patients who underwent MitraClip implantation were obtained from an ongoing prospective registry. Two different groups, divided according to baseline echocardiographic criteria (investigational group [EVERESTOFF] and control group [EVERESTON]), were compared. RESULTS: Seventy-eight patients were included in EVERESTOFF and 93 patients in EVERESTON groups. Important and comparable acute reductions in MR and no clip-related complications were revealed. The primary safety endpoint at 30 days was comparable between groups (2.6% vs. 6.5%, respectively, p = 0.204); in addition, MR reduction was mostly sustained, whereas equivalent improvement in New York Heart Association functional class were demonstrated. Kaplan-Meier freedom from death, surgery for mitral valve dysfunction, or grade ≥3+ MR at 12 months was demonstrated in 71.4% and 76.2%, respectively, in the EVERESTOFF and EVERESTON groups (log rank p = 0.378). Significant improvements in ejection fraction and reduction in left ventricle volumes were demonstrated in both groups over time, but the baseline between-group differences were sustained. CONCLUSIONS: MitraClip implantation in patients with expanded baseline echocardiographic features, compared with the control group, was associated with similar rates of safety and efficacy through 12-month follow-up. Further validation of our findings is warranted.