Percutaneous closure of incomplete surgical left atrial appendage ligation: success begins with the decision to try.

The authors present a case of percutaneous closure of an incomplete surgical left atrial appendage (LAA) ligation with a new device LAmbre (Lifetech ScientificCo Ltd).

Experience with the ACURATE neo and neo2 transcatheter aortic valves in Spain. The PRECISA (PRospective Evaluation Complementing Investigation with ACURATE devices) registry.

BACKGROUND: Previous studies have documented a high rate of implantation success with the ACURATE neo2 valve, as well as a reduction in paravalvular leak (PVL) compared to its predecessor, the ACURATE neo. However, there are no studies that have reviewed and compared the long-term clinical and hemodynamic outcomes of these patients. AIMS: This study aimed to evaluate the results of the ACURATE neo transcatheter aortic valve in a real-world context, and to compare the results of the outcomes of both generations of this device (ACURATE neo and ACURATE neo2), with a specific focus on procedural success, safety, and long-term effectiveness. METHODS: A prospective study including all consecutive patients treated with the ACURATE neo device in seven hospitals was conducted (Clinical Trials Identification Number: NCT03846557). The primary endpoint consisted of a composite of adverse events, including mortality, aortic insufficiency, and other procedural complications. As the second-generation device (ACURATE neo2) replaced the ACURATE neo during the study period, hemodynamic and clinical results before admission, at 30 days, and at 1 year of follow-up were compared between the two generations. RESULTS: A total of 296 patients underwent transcatheter aortic valve implantation with the ACURATE device, with 178 patients receiving the ACURATE neo and 118 patients receiving the ACURATE neo2. In the overall population, the absence of device success occurred in 14.5%. The primary reason for the absence of device success was the presence of para-valvular regurgitation ≥ 2. There were no instances of coronary occlusions, valve embolization, annulus rupture, or procedural deaths. ACURATE neo2 was associated with a significantly higher device success rate (91.7% vs. 82%, p = 0.04), primarily due to a significantly lower rate of para-valvular regurgitation, which remained significant at 1 year. CONCLUSION: The use of ACURATE neo and neo2 transcatheter aortic valves is associated with satisfactory clinical results and an extremely low rate of complications. The ACURATE neo2 enables a significantly higher device success rate, primarily attributed to a significant reduction in the rate of PVL.

Bicaval TricValve Implantation in Patients With Severe Symptomatic Tricuspid Regurgitation: 1-Year Follow-Up Outcomes.

BACKGROUND: Several orthotopic transcatheter strategies have been developed to treat severe tricuspid regurgitation (TR); however, many patients are deemed unsuitable. Caval valve implantation with the TricValve system addresses this unmet need. OBJECTIVES: This study sought to determine the impact of TricValve on systemic congestion and quality of life (QOL) at 1 year. METHODS: The TRICUS (Safety and Efficacy of the TricValve® Transcatheter Bicaval Valves System in the Superior and Inferior Vena Cava in Patients With Severe Tricuspid Regurgitation) and TRICUS EURO studies were prospective, nonblinded, nonrandomized, single-arm trials representing the early-in-man experience of the TricValve system in NYHA functional class III or IV severe TR patients, optimally medicated and ineligible for open heart surgery, with significant caval backflow. The primary endpoint was QOL metrics and functional status. The 1-year results of the combined cohort are described here. RESULTS: Forty-four patients were included. Mean age was 76.2 ± 7.5 years, 81.0% were women, and the TRISCORE (risk score model for isolated tricuspid valve surgery) was 5.3 ± 1.3. Clinical improvement at 1 year was achieved in 42 (95.5%) patients, measured by (at least 1 of) an increase in ≥15 points from baseline in 12-item Kansas City Cardiomyopathy Questionnaire score, improvement to NYHA functional class to I or II, or an increase ≥40 m in the 6-minute walk test. There were 3 (6.8%) deaths at 1-year follow-up (1 cardiovascular), and the heart failure rehospitalization rate was 29.5%. Stent fracture, conduction system disturbances, or clinically significant leaflet thrombosis were not detected. Abolished hepatic vein backflow was achieved and persisted in 63.8% of the patients, contributing towards a reduction in congestive symptoms, N-terminal pro-B-type natriuretic peptide levels (P = 0.032), and diuretic treatment. CONCLUSIONS: Caval valve implantation with the TricValve system associated with meaningful 1-year clinical improvements in terms of QOL along with relatively low mortality rates. (TRICUS Study - Safety and Efficacy of the TricValve® Device; NCT03723239).

STREI: a new index of right heart function in isolated severe tricuspid regurgitation by Speckle tracking Echocardiography.

AIMS: Right ventricular (RV) performance determines clinical management in severe tricuspid regurgitation (TR). Right atrial (RA) function complements RV assessment in TR. This study aimed to design a novel index by Speckle-tracking echocardiography (STREI index) integrating RA and RV strain information and to evaluate the clinical utility of combining RV and RA strain for prediction of cardiovascular (CV) outcomes. METHODS AND RESULTS: Consecutive patients with at least (≥) severe TR evaluated in the Heart Valve Clinic (n = 300) were prospectively included. An additional independent TR cohort was included for external validation (n = 50). STREI index was developed with the formula: [2 * RV-free wall longitudinal strain (RV-FWLS)] + Reservoir RA strain (RASr). The composite endpoint included hospital admission due to HF and all cause-mortality. 176 patients with ≥ severe TR were finally included. STREI index identified a higher percentage of patients with RV dysfunction compared to conventional parameters. After a median follow-up of 2.2 years (IQR: 12-41 months), 38% reached the composite endpoint. STREI values were predictors of outcomes independently of TR severity and RV dimensions. The combination of prognostic cut-off values of RASr (<10%) and RV-FWLS (>-20%) (STREI stratification) stratified 4 different groups of risk independently of TR severity, RV dimensions and clinical status (adj HR per stratum 1.89 (1.4-2.34), p < 0.001). Pre-defined cut-off values achieved similar prognostic performance in the validation cohort (n = 50). CONCLUSION: STREI index is a novel parameter of RV performance that independently predicts CV events. The combination of RA and RV strain stratifies better patients' risk, reflecting a broader effect of TR on right heart chambers.

La clasificación 4A para pacientes con insuficiencia tricuspídea / The 4A classification for patients with tricuspid regurgitation

Introducción y objetivos: La insuficiencia tricuspídea (IT) significativa se asocia con un aumento de la morbimortalidad. La valoración clínica del paciente con IT es un reto. Nuestro objetivo es establecer una nueva clasificación clínica, específica para pacientes con IT, denominada clasificación 4A, y evaluar su impacto pronóstico. Métodos: Se incluyó a pacientes evaluados en la clínica valvular, con IT aislada al menos grave y ausencia de antecedentes de insuficiencia cardiaca (IC). Se recogieron síntomas y signos de astenia, edema en extremidades inferiores, dolor o distensión abdominal y anorexia (asthenia, ankle swelling, abdominal pain or distention and anorexia) y se realizó un seguimiento cada 6 meses. La clasificación 4A abarca desde A0 (ninguna A) a A3 (3 o 4 Aes). Se definió un resultado combinado de ingreso hospitalario debido a IC derecha o muerte de causa cardiovascular. Resultados: Se incluyó a 135 pacientes con IT significativa entre 2016 y 2021 (el 69% mujeres; media de edad, 78±7 años). Durante un seguimiento medio de 26 [intervalo intercuartílico, 10-41] meses, 53 pacientes (39%) alcanzaron el resultado combinado. Ingresaron por IC 46 (34%) y murió un 5% (n=7). Al inicio, el 94% de los pacientes se encontraban en NYHA I o II, mientras que el 24% ya presentaba A2 o A3. La presencia de A2 o A3 se asoció con una alta incidencia de eventos. El cambio en la puntuación de la clasificación 4A fue un marcador independiente de IC y muerte cardiovascular (HR ajustada por unidad de cambio de la clasificación 4A=1,95 [1,37-2,77]; p <0,001). Conclusiones: Se muestra una nueva clasificación clínica específica para pacientes con IT basada en signos y síntomas de IC derecha y predictora de eventos.

Introduction and objectives: Significant tricuspid regurgitation (TR) is associated with increased morbidity and mortality. Clinical evaluation of TR patients is challenging. Our aim was to establish a new clinical classification specific for patients with TR, the 4A classification, and evaluate its prognostic performance. Methods: We included patients with isolated TR that was at least severe and without previous episodes of heart failure (HF) who were assessed in the heart valve clinic. We registered signs and symptoms of asthenia, ankle swelling, abdominal pain or distention and/or anorexia and followed up the patients every 6 months. The 4A classification ranged from A0 (no A) to A3 (3 or 4 As present). We defined a combined endpoint consisting of hospital admission due to right HF or cardiovascular mortality. Results: We included 135 patients with significant TR between 2016 and 2021 (69% females, mean age 78±7 years). During a median follow-up of 26 [IQR, 10-41] months, 39% (n=53) patients had the combined endpoint: 34% (n=46) were admitted for HF and 5% (n=7) died. At baseline, 94% of the patients were in NYHA I or II, while 24% were in classes A2 or A3. The presence of A2 or A3 conferred a high incidence of events. The change in 4A class remained an independent marker of HF and cardiovascular mortality (adjusted HR per unit of change of 4A class, 1.95 [1.37-2.77]; P<.001). Conclusions: This study reports a novel clinical classification specifically for patients with TR that is based on signs and symptoms of right HF and has prognostic value for events.(AU)

Clinical outcomes of TAVI with the Myval balloon-expandable valve for non-calcified aortic regurgitation.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) in non-calcified aortic regurgitation (NCAR) is an off-label procedure. The balloon-expandable Myval includes extra-large sizes (30.5 mm and 32 mm) of interest in this setting. AIMS: We aimed to evaluate the safety and feasibility of Myval in NCAR. METHODS: This was an international, multicentre, observational study that enrolled all consecutive patients with symptomatic severe NCAR undergoing TAVR with the Myval device. The images were centrally analysed. RESULTS: A total of 113 patients were recruited, 64.6% were men, the mean age was 78.4±7.5 years, and the Society of Thoracic Surgeons score was 2.7±1.7%. Aortic root dilatation was present in 59.3% of patients, 7.1% were bicuspid, and the mean annular area was 638.6±106.0 mm2. The annular area was beyond the recommended range for extra-large sizes in 2.6% of cases, and additional volume was added in 92% (median 4 cc, up to 9 cc). The extra-large sizes were used in 95 patients (84.1%), and the mean oversizing was 17.9±11.0%. The technical success rate was 94.7%; the rate of residual ≥moderate aortic regurgitation was 8.9%, and the pacemaker rate was 22.2%. There were no cases of annular rupture, cardiac tamponade, or aortic dissection, but in 4 patients (3.5%) valve embolisation occurred (1 antegrade and 3 ventricular), all in cases with a tapered left ventricle outflow tract (p=0.007). Thirty-day and 1-year mortality were 5.3% and 9.7%, respectively. Technical success was associated with better survival (97.1% vs 72.7%; p=0.012), and valve embolisation was the main determinant of mortality (p=0.047). CONCLUSIONS: Myval is a feasible and safe option for selected non-operable patients with NCAR and demonstrated good midterm outcomes and lack of impact of oversizing on device durability.

Clinical utility and prognostic value of right atrial function in severe tricuspid regurgitation: one more piece of the puzzle.

AIMS: The optimal management of severe tricuspid regurgitation (TR) remains controversial. While right ventricular systolic function is an established prognostic marker of outcomes, the potential role of right atrial (RA) function is unknown. This study aimed to describe RA function by 2D speckle-tracking echocardiography (STE) in at least severe TR and to evaluate its potential association with cardiovascular outcomes. METHODS AND RESULTS: Consecutive patients with at least (≥) severe TR (severe, massive, or torrential TR) evaluated in the Heart Valve Clinic following a comprehensive clinical protocol were included. Consecutive control subjects and patients with permanent isolated atrial fibrillation (AF) were included for comparison (control and AF group, respectively). RA function was measured with 2D-STE and two components of RA function were calculated: reservoir (RASr) and contractile (RASct) strain (AutoStrain, Philips Medical Systems the EPIQ system). A combined endpoint of hospital admission due to heart failure (HF) or all-cause mortality was defined. Patients with ≥ severe TR (n = 140) showed lower RASr compared with controls (n = 20) and with the AF group (n = 20) (P < 0.001). Atrial TR showed lower RASr compared with other aetiologies of TR (P < 0.001). After a median follow-up of 2.2 years (IQR: 12-41 months), RASr remained an independent predictor of mortality and HF. A cut-off value of RASr of <9.4% held the best accuracy to predict outcomes. CONCLUSION: RA function by 2D-STE independently predicts mortality and HF hospitalizations in patients with ≥ severe TR.

Transcatheter Tricuspid Annuloplasty in a Patient With Very Long Segment of Right Coronary Artery Proximity.

A 78-year-old woman with severe symptomatic secondary atrial tricuspid regurgitation and a long segment of right coronary artery proximity in the posterior tricuspid annulus was treated with transcatheter annuloplasty. Six consecutive anchors were implanted at the level of the atrial wall, crossing the right coronary artery, achieving residual mild regurgitation. (Level of Difficulty: Advanced.).

The 4A classification for patients with tricuspid regurgitation.

INTRODUCTION AND OBJECTIVES: Significant tricuspid regurgitation (TR) is associated with increased morbidity and mortality. Clinical evaluation of TR patients is challenging. Our aim was to establish a new clinical classification specific for patients with TR, the 4A classification, and evaluate its prognostic performance. METHODS: We included patients with isolated TR that was at least severe and without previous episodes of heart failure (HF) who were assessed in the heart valve clinic. We registered signs and symptoms of asthenia, ankle swelling, abdominal pain or distention and/or anorexia and followed up the patients every 6 months. The 4A classification ranged from A0 (no A) to A3 (3 or 4 As present). We defined a combined endpoint consisting of hospital admission due to right HF or cardiovascular mortality. RESULTS: We included 135 patients with significant TR between 2016 and 2021 (69% females, mean age 78±7 years). During a median follow-up of 26 [IQR, 10-41] months, 39% (n=53) patients had the combined endpoint: 34% (n=46) were admitted for HF and 5% (n=7) died. At baseline, 94% of the patients were in NYHA I or II, while 24% were in classes A2 or A3. The presence of A2 or A3 conferred a high incidence of events. The change in 4A class remained an independent marker of HF and cardiovascular mortality (adjusted HR per unit of change of 4A class, 1.95 [1.37-2.77]; P<.001). CONCLUSIONS: This study reports a novel clinical classification specifically for patients with TR that is based on signs and symptoms of right HF and has prognostic value for events.

Prognostic Impact of Right Ventricular Strain in Isolated Severe Tricuspid Regurgitation.

BACKGROUND: Right ventricular (RV) systolic function is an established marker of outcomes in patients with severe tricuspid regurgitation (TR). Timely detection of RV dysfunction using conventional two-dimensional echocardiography is challenging. RV strain has emerged as an accurate and sensitive tool for the evaluation of RV function, with the capability to detect subclinical RV dysfunction. The aim of this study was to evaluate the prognostic value of RV strain parameters in early stages of severe TR. METHODS: Consecutive patients with at least severe TR (severe, massive, or torrential) and the absence of a formal indication for tricuspid valve intervention in secondary TR evaluated in the Heart Valve Clinic were prospectively included. RV systolic function was measured using conventional echocardiographic indices (RV fractional area change, tricuspid annular plane systolic excursion, and Doppler tissue imaging S wave [S']) and speckle-tracking echocardiography-derived automatic peak global longitudinal strain and free wall longitudinal strain (FWLS) using an automated two-dimensional strain analytic software. A combined end point of hospital admission due to heart failure or all-cause mortality was defined. RESULTS: A total of 266 patients were enrolled in the study, and 151 were ultimately included. Strain parameters detected a higher percentage of abnormal RV values compared with conventional indices. During a median follow-up period of 26 months (interquartile range, 13-42 months), 35% of the patients reached the combined end point. Cumulative event-free survival was significantly worse in patients with impaired RV global longitudinal strain and RV FWLS. Conventional indices of RV systolic function were not associated with outcomes (P > .05 for all). On multivariate analysis, RV FWLS was independently associated with mortality and heart failure (adjusted hazard ratio for abnormal RV FWLS, 5.90; 95% CI, 3.17-10.99; P < .001). CONCLUSION: In early stages of severe TR, RV FWLS is more frequently impaired compared with conventional indices of RV function. Among all parameters, RV FWLS is the strongest predictor of mortality and heart failure, independent of additional prognostic markers.