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INTRODUCTION AND OBJECTIVES: Thrombocytopenia frequently occurs after transcatheter aortic valve implantation (TAVI) but its impact is poorly understood. We aimed to analyze the incidence, clinical impact, and predictors of acquired thrombocytopenia after TAVI. METHODS: This retrospective multicenter registry included 3913 patients undergoing TAVI with a baseline platelet count of ≥ 100 *109/L. Acquired thrombocytopenia was defined as a decrease in baseline platelet count of ≥ 50% (early nadir ≤ 3 days and late nadir ≥ 4 days) post-TAVI. The primary endpoint was 30-day all-cause mortality and secondary endpoints were procedural safety and 2-year all-cause mortality. RESULTS: The incidence of acquired thrombocytopenia was 14.8% (early nadir: 61.5%, late nadir: 38.5%). Thirty-day mortality occurred in 112 (3.0%) patients and was significantly higher in those with thrombocytopenia (8.5% vs 2.0%, adjusted OR, 2.3; 95%CI, 1.3-4.2). Procedural safety was lower and 2-year mortality was higher in patients with thrombocytopenia vs those without (47.9 vs 33.0%; P < .001, and 30.2% vs 16.8%; HR, 2.2, 95%IC, 1.3-2.7) and especially in those with late nadir thrombocytopenia (54.2% vs 45.5%; P = .056, and 38.6% vs 23.8%, HR, 2.1; 95%CI, 1.5-2.9). Independent predictors of thrombocytopenia comprised baseline and procedural factors such as body surface area, absence of diabetes, poorer renal function, peripheral vascular disease, nontransfemoral access, vascular complications, type of transcatheter heart valve, and earlier TAVI procedures. CONCLUSIONS: Acquired thrombocytopenia was common (15%) after TAVI and was associated with increased short- and mid-term mortality and decreased procedural safety. Moreover, late thrombocytopenia compared with early thrombocytopenia was associated with significantly worse clinical outcomes. Further investigations are needed to elucidate the etiologic mechanisms behind these findings.

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BACKGROUND: Hemodynamic impact of commissural alignment (CA) with self-expandable transcatheter aortic valves (TAVR) has not been investigated yet. AIMS: To determine hemodynamic impact of CA with self-expandable TAVR. METHODS: Multicentric ambispective study comparing patients who underwent self-expandable TAVR in seven centers with the Evolut Pro/Pro+ (EP) (Medtronic) and Acurate neo2 (AN2) (Boston Scientific) with and without CA strategies. The degree of commissural misalignment (CMA) was assessed by computed tomography/angiography and 1-year transvalvular gradients/regurgitation evaluated by echocardiography. A matched comparison according to annular dimensions/eccentricity, prosthesis size/type, and baseline left ventricular function and gradients was performed. RESULTS: A total of 557 patients, mean age 80.7 ± 6.6 years, 61.4% men, and STS score of 4.3 ± 3.1% were analyzed. A CA technique was attempted in 215 patients (38.6%), including 113 patients with AN2 and 102 patients with EP. None/mild CMA was found in 158 (73.5% vs. 43.6% if no CA attempted, p < 0.001) with no differences between devices (AN2:75.2%; EP:71.6%, p = 0.545). Patients with moderate/severe CMA had a greater aortic peak gradient (22.3 ± 8.7 vs. 19.7 ± 8.5, p = 0.001), significantly greater progression of both peak (p = 0.002) and mean gradients (p = 0.001) after matching, and higher rate of central aortic regurgitation (1.2% vs. 0.4%, p = 0.005) at 1-year, but not a greater proportion of patients with mean gradient ≥ 10 mmHg. CONCLUSIONS: The use of CA strategies significantly reduced the rate of CMA for the self-expandable TAVR devices ACN2 and EP which was associated to lower transvalvular gradients and intra-prosthetic regurgitation progression at 1-year although no criteria of structural deterioration were met at this follow up. CLINICALTRIALS: org: NCT05097183.

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BACKGROUND: The effectiveness of complete revascularization is well established in patients with ST-segment elevation myocardial infarction (STEMI), but it is less investigated in those with non-ST-segment elevation myocardial infarction (NSTEMI). OBJECTIVES: This study aimed to assess whether complete revascularization, compared with culprit-only revascularization, was associated with consistent outcomes in older patients with STEMI and NSTEMI. METHODS: In the FIRE (Functional Assessment in Elderly MI Patients with Multivessel Disease) trial, 1,445 older patients with myocardial infarction (MI) were randomized to culprit-only or physiology-guided complete revascularization, stratified by STEMI (n = 256 culprit-only vs n = 253 complete) and NSTEMI (n = 469 culprit-only vs n = 467 complete). The primary outcome comprised a composite of death, MI, stroke, or revascularization at 1 year. The key secondary outcome included a composite of cardiovascular death or MI at 1 year. RESULTS: In the overall study population, physiology-guided complete revascularization reduced both primary and key secondary outcomes. The primary outcome occurred in 54 (21.1%) STEMI patients randomized to culprit-only vs 41 (16.2%) STEMI patients of the complete group (HR: 0.75; 95% CI: 0.50-1.13) and in 98 (20.9%) NSTEMI patients randomized to culprit-only vs 72 (15.4%) NSTEMI patients of the complete group (HR: 0.71; 95% CI: 0.53-0.97), with negative interaction testing (P for interaction, 0.846). Similarly, no signal of heterogeneity with respect to the initial clinical presentation was observed for the key secondary endpoint (P for interaction, 0.654). CONCLUSIONS: Physiology-guided complete revascularization, compared with culprit-only revascularization, provided consistent benefit across the whole spectrum of patients with MI. (FIRE [Functional Assessment in Elderly MI Patients With Multivessel Disease]; NCT03772743).

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INTRODUCTION AND OBJECTIVES: Impact of gender on long-term outcomes after transcatheter aortic valve implantation (TAVI) remains uncertain. We aimed to investigate gender-specific differences in TAVI and its impact on outcomes. METHODS: This analysis used data from the prospective Spanish TAVI registry, which included consecutive TAVI patients treated in 46 Spanish centers from 2009 to 2021. The primary endpoint was all-cause mortality at 12 months. Secondary endpoints included in-hospital and 30-day mortality and TAVI-related complications. Adjusted logistic and Cox regression analyses were performed. RESULTS: The study included 12 253 consecutive TAVI patients with a mean age of 81.2 ± 6.4 years. Women (53.9%) were older, and had a higher STS-PROM score (7.0 ± 7.0 vs 6.2 ± 6.7; P < .001) than men. Overall, the TAVI-related complication rate was similar between women and men, with specific gender-related complications. While women more frequently developed in-hospital vascular complications (13.6% vs 9.8%; P < .001) and cardiac tamponade (1.5% vs 0.6%; P = .009), men showed a higher incidence of permanent pacemaker implantation (14.5% vs 17.4%; P = .009). There was no difference in all-cause mortality either in hospital (3.6% vs 3.6%, adjusted odds ratio [OR], 1.01; 95% confidence interval [95%CI], 0.83-1.23; P = .902), at 30 days (4.2% vs 4.2%, adjusted OR, 0.90; 95%CI, 0.65-1.25; P = .564) or at 1 year (11% vs 13%, adjusted HR, 0.94; [0.80-1.11]; P = .60). CONCLUSIONS: women treated with TAVI are older and have more comorbidities than men, leading to distinct complications between genders. Nevertheless, all-cause mortality in the short-term and at 1-year was similar between men and women.

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The percutaneous treatment of structural, valvular, and non-valvular heart disease (SHD) is rapidly evolving. The Core Curriculum (CC) proposed by the EAPCI describes the knowledge, skills, and attitudes that define competency levels required by newly trained SHD interventional cardiologists (IC) and provides guidance for training centres. SHD ICs are cardiologists who have received complete interventional cardiology training. They are multidisciplinary team specialists who manage adult SHD patients from diagnosis to follow-up and perform percutaneous procedures in this area. They are competent in interpreting advanced imaging techniques and master planning software. The SHD ICs are expected to be proficient in the aortic, mitral, and tricuspid areas. They may have selective skills in either the aortic area or mitral/tricuspid areas. In this case, they must still have common transversal competencies in the aortic, mitral, and tricuspid areas. Additional SHD domain competencies are optional. Completing dedicated SHD training, aiming for full aortic, mitral, and tricuspid competencies, requires at least 18 months. For full training in the aortic area, with basic competencies in mitral/tricuspid areas, the training can be reduced to 1 year. The same is true for training in the mitral/tricuspid area, with competencies in the aortic area. The SHD IC CC promotes excellence and homogeneous training across Europe and is the cornerstone of future certifications and patient protection. It may be a reference for future CC for national associations and other SHD specialities, including imaging and cardiac surgery.

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BACKGROUND: The off-label utilization of transcatheter heart valve (THV) devices for the treatment of inoperable or high-surgical risk patients with pure native aortic valve regurgitation (NAVR) has demonstrated suboptimal outcomes, both with self- and balloon-expandable (BE) devices. The aim of this study is to compare the use of different BE scaffolds in treating pure NAVR. METHODS: Consecutive patients with pure severe NAVR who were deemed to be at high-risk and were treated with last-generation BE-THVs among seventeen Centers in Europe and US. Technical and device success rates were the primary objectives. RESULTS: Between February 2018 and July 2023, among 144 patients, 41 (28 %) received a MyVal device and 103 (72 %) were treated with a Sapien THV. Patients treated with a MyVal THV had an extra-large annulus more frequently compared to the Sapien group (49%vs.20 %, p < 0.001). Technical and device success rates were 90 % and 81 %, respectively, p > 0.1. The rate of THV migration/embolization (MyVal 4.9%vs. Sapien 11 %, p = 0.4) and second valve needed (4.9%vs.7.8 %, p = 0.7) were numerically lower in the MyVal group, whereas the rate of at least moderate paravalvular leak (15%vs.7.8 %, p = 0.2) and permanent pacemaker implantation (25%vs.18 %, p = 0.16) were numerically higher in the Myval group. CONCLUSIONS: Off-label use of BE devices for pure NAVR represents a potential alternative in high-risk patients in the absence of dedicated devices. However, BE in NAVR is associated with suboptimal outcomes. The availability of larger THV sizes may introduce transcatheter aortic valve replacement as an effective treatment for patients traditionally deemed unsuitable. NON-STANDARD ABBREVIATIONS AND ACRONYMS: AR = aortic regurgitation, BE = balloon-expandable, NAVR = native aortic valve regurgitation, PM = pacemaker, TAVR = transcatheter aortic valve replacement, THV = transcatheter heart valve, TVEM = transcatheter valve embolization and migration, VARC-3 = Valve Academic Research Consortium 3.

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BACKGROUND: Antithrombotic treatment (ATT) post-left atrial appendage occlusion (LAAO) remains controversial. Furthermore, most of the patients undergoing LAAO are at a very high bleeding risk. AIMS: This study aimed to compare a simplified versus conventional ATT after LAAO in very high bleeding risk patients. METHODS: This is a multicentre, retrospective study including very high bleeding risk patients, according to the Bleeding Academic Research Consortium (BARC) definition, who underwent LAAO. These included patients at >4% risk of BARC 3 to 5 bleeding or >1% risk of intracranial bleeding after the procedure. Two groups were established based on the discharge ATT. The simplified group included single antiplatelet treatment or no treatment, and the conventional group comprised dual antiplatelet treatment or anticoagulation (combined or not with antiplatelet therapy). RESULTS: A total of 1,135 patients were included. The mean CHA2DS2-VASc and HAS-BLED scores were 4.5±1.5 and 3.7±1.0, respectively. There were no differences in the composite endpoint (death, stroke, transient ischaemic attack, device-related thrombus or major bleeding) between the 2 groups (hazard ratio [HR] 0.81, 95% confidence interval [CI]: 0.59-1.11; p=0.188). Although the rate of major bleeding during the first year was numerically lower in the simplified group, it did not reach statistical significance (HR 0.67, 95% CI: 0.41-1.10; p=0.104). Nonetheless, patients with previous major bleeding presented a significantly lower rate of major bleeding when using the simplified treatment (HR 0.61, 95% CI: 0.36-0.99; p=0.049). CONCLUSIONS: In patients with very high bleeding risk, a simplified ATT after LAAO seems to be as effective as conventional protocols. Furthermore, patients with a history of major bleeding experienced a lower risk of major bleeding with the simplified ATT.

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Apéndice Atrial , Fibrilación Atrial , Fibrinolíticos , Hemorragia , Inhibidores de Agregación Plaquetaria , Humanos , Apéndice Atrial/cirugía , Masculino , Femenino , Anciano , Estudios Retrospectivos , Fibrilación Atrial/complicaciones , Fibrilación Atrial/tratamiento farmacológico , Inhibidores de Agregación Plaquetaria/uso terapéutico , Inhibidores de Agregación Plaquetaria/efectos adversos , Anciano de 80 o más Años , Fibrinolíticos/uso terapéutico , Fibrinolíticos/efectos adversos , Hemorragia/inducido químicamente , Resultado del Tratamiento , Factores de Riesgo , Anticoagulantes/uso terapéutico , Anticoagulantes/efectos adversos , Accidente Cerebrovascular/prevención & control , Accidente Cerebrovascular/etiología , Medición de Riesgo , Terapia Antiplaquetaria Doble/métodos , Persona de Mediana Edad , Cierre del Apéndice Auricular Izquierdo

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Background: Patients with cardiogenic shock (CS) and mitral regurgitation (MI) have a prohibitive risk that contraindicates surgical treatment. Although the feasibility of transcatheter edge-to-edge therapy (TEER) has been demonstrated in this setting, the benefit of the combined use of TEER with mechanical circulatory support devices (MCS) has not been studied. The aim of this study was to evaluate the clinical outcomes of TEER in patients with MCS. Methods: The MITRA-ASSIST study is a retrospective multicentre Spanish registry that included patients with MR and CS who underwent TEER in combination with MCS. The primary endpoint was death from any cause at 12 months. The secondary endpoint was a composite of death from any cause or hospitalisation for heart failure at 12 months. Results: A total of twenty-four patients in nine high-volume Spanish centres (66.2 (51-82) years, 70.8% female, EuroSCORE II 20.4 ± 17.8) were included. Acute ST-elevation myocardial infarction was the main CS aetiology (56%), and the most implanted MCS was the intra-aortic balloon pump (82.6%), followed by ECMO (8.7%), IMPELLACP® (4.3%), or a combination of both (4.3%). Procedural success was 95.8%, with 87.5% in-hospital survival. At 12-month follow-up, 25.0% of patients died, and 33.3% had a composite event of death from any cause or hospitalisation for heart failure. Conclusions: TEER in patients with concomitant CS and MR who require MCS appears to be a promising therapeutic alternative with a high device procedural success rate and acceptable mortality and heart failure readmission rates at follow-up.

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BACKGROUND: The current incidence and outcomes of structural transcatheter procedures in heart transplant (HTx) recipients and left-ventricular assist devices (LVAD) carriers is unknown. AIMS: To provide insights on structural transcatheter procedures performed across HTx and LVAD patients in Spain. METHODS: Multicenter, ambispective, observational nationwide registry. RESULTS: Until May/2023, 36 percutaneous structural interventions were performed (78% for HTx and 22% for LVAD) widely varying among centers (0%-1.4% and 0%-25%, respectively). Percutaneous mitral transcatheter edge-to-edge (TEER) was the most common (n = 12, 33.3%), followed by trancatheter aortic valve replacement (n = 11, 30.5%), and tricuspid procedures (n = 9, 25%). Mitral TEER resulted in mild residual mitral regurgitation in all but one case, mean gradient was <5 mmHg in 75% of them at 1-year, with no mortality and 8.3% re-admission rate. Tricuspid TEER resulted in 100% none/mild residual regurgitation with a 1-year mortality and readmission rates of 22% and 28.5%, respectively. Finally, trancatheter aortic valve replacement procedures (n = 8 in LVADs due to aortic regurgitation and n = 3 in HTx), were successful in all cases with one prosthesis degeneration leading to severe aortic regurgitation at 1-year, 18.2% mortality rate and no re-admissions. Globally, major bleeding rates were 7.9% and 12.5%, thromboembolic events 3.7% and 12.5%, readmissions 37% and 25%, and mortality 22% and 25%, in HTx and LVADs respectively. No death was related to the implanted transcatheter device. CONCLUSIONS: Most centers with HTx/LVAD programs perform structural percutaneous procedures but with very inconsistent incidence. They were associated with good safety and efficacy, but larger studies are required to provide formal recommendations.

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Trasplante de Corazón , Corazón Auxiliar , Sistema de Registros , Humanos , Masculino , Femenino , Persona de Mediana Edad , España/epidemiología , Anciano , Cateterismo Cardíaco/métodos , Adulto , Insuficiencia Cardíaca/cirugía , Insuficiencia Cardíaca/terapia , Insuficiencia Cardíaca/epidemiología

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INTRODUCTION AND OBJECTIVES: Transcatheter mitral valve replacement (TMVR) is an emerging treatment alternative for mitral valve (MV) disease in patients who were ineligible for surgical intervention or edge-to-edge repair. This study aimed to assess the short- and mid-term outcomes of this procedure. METHODS: We conducted a prospective registry to include the initial experience with symptomatic, consecutive patients who underwent TMVR using the transapical Tendyne system at 7 centers in the Iberian Peninsula. Baseline clinical and imaging data, periprocedural information, and follow-up assessments were collected at 1 month and 1 year. RESULTS: A total of 40 patients (mean age 78.5 years [76-82], 47,5% males) underwent TMVR. The majority had significant surgical risk, comorbidities, and advanced functional class. All patients had significant mitral regurgitation (MR), except for 2 with severe stenosis. Previous MV intervention and off-label indication for the procedure were present in 4 (10.0%) and 8 (20.0%) patients, respectively. Technical success was recorded in 100%, device success in 95.0%, and procedural success in 85.0% at 30-day. All-cause mortality was 2.5% and 17.5% at the 1-month and 1-year follow-up, respectively. MR reduction (≤ 1) and functional class improvement (NYHA I-II) were observed at 1 year in 93.9% and 87.9% of survivors, respectively. CONCLUSIONS: Treatment with TMVR produced enduring resolution of MV disease and notable functional enhancement at 1 year of follow-up. The procedure demonstrated a satisfactory early safety profile, although 1-year mortality remained relatively high in this high-risk population.

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BACKGROUND: Severe pure aortic regurgitation (AR) carries a high mortality and morbidity risk, and it is often undertreated because of the inherent surgical risk. Transcatheter heart valves (THVs) have been used off-label in this setting with overall suboptimal results. The dedicated "purpose-built" Jena Valve Trilogy (JVT, JenaValve Technology) showed an encouraging performance, although it has never been compared to other THVs. OBJECTIVES: The aim of our study was to assess the performance of the latest iteration of THVs used off-label in comparison to the purpose-built JVT in inoperable patients with severe AR. METHODS: We performed a multicenter, retrospective registry with 18 participating centers worldwide collecting data on inoperable patients with severe AR of the native valve. A bicuspid aortic valve was the main exclusion criterion. The primary endpoints were technical and device success, 1-year all-cause mortality, and the composite of 1-year mortality and the heart failure rehospitalization rate. RESULTS: Overall, 256 patients were enrolled. THVs used off-label were used in 168 cases (66%), whereas JVT was used in 88 (34%). JVT had higher technical (81% vs 98%; P < 0.001) and device success rates (73% vs 95%; P < 0.001), primarily driven by significantly lower incidences of THV embolization (15% vs 1.1%; P < 0.001), the need for a second valve (11% vs 1.1%; P = 0.004), and moderate residual AR (10% vs 1.1%; P = 0.007). The permanent pacemaker implantation rate was comparable and elevated for both groups (22% vs 24%; P = 0.70). Finally, no significant difference was observed at the 1-year follow-up in terms of mortality (HR: 0.99; P = 0.980) and the composite endpoint (HR: 1.5; P = 0.355). CONCLUSIONS: The JVT platform has a better acute performance than other THVs when used off-label for inoperable patients with severe AR. A longer follow-up is conceivably needed to detect a possible impact on prognosis.

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Insuficiencia de la Válvula Aórtica , Válvula Aórtica , Prótesis Valvulares Cardíacas , Diseño de Prótesis , Sistema de Registros , Índice de Severidad de la Enfermedad , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Insuficiencia de la Válvula Aórtica/fisiopatología , Insuficiencia de la Válvula Aórtica/mortalidad , Insuficiencia de la Válvula Aórtica/diagnóstico por imagen , Insuficiencia de la Válvula Aórtica/etiología , Femenino , Masculino , Estudios Retrospectivos , Anciano , Resultado del Tratamiento , Anciano de 80 o más Años , Factores de Riesgo , Válvula Aórtica/cirugía , Válvula Aórtica/fisiopatología , Válvula Aórtica/diagnóstico por imagen , Factores de Tiempo , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad , Reemplazo de la Válvula Aórtica Transcatéter/instrumentación , Readmisión del Paciente , Recuperación de la Función , Europa (Continente) , Insuficiencia Cardíaca/mortalidad , Insuficiencia Cardíaca/terapia , Insuficiencia Cardíaca/fisiopatología , Insuficiencia Cardíaca/diagnóstico , Hemodinámica

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Objective: Bleeding is frequent during transcatheter aortic valve implantation (TAVI), especially when performed through a transapical approach (TA), and is associated with a worse prognosis. The present study aims to test the implication of red blood cell (RBC) transfusion and the optimal transfusion strategy in this context. Methods: Among 11,265 participants in the multicenter TRITAVI (Transfusion Requirements in Transcatheter Aortic Valve Implantation) registry, 548 patients (4.9%) who received TA-TAVI at 19 European centers were included. One-to-one propensity score matching was performed to reduce treatment selection bias and potential confounding among transfused versus non-transfused patients. The primary endpoint of the study was the 30-day occurrence of all-cause mortality. Results: 209 patients (38 %) received RBC transfusions. The primary endpoint occurred in 47 (8.6 %) patients. Propensity score matching identified 188 pairs of patients with and without RBC transfusion. In the propensity score-matched analysis, RBC transfusion was associated with increased 30-day mortality (HR 3.35, 95 % CI 1.51 - 7.39; p = 0.002). At multivariable cox regression analysis, RBC transfusion was an independent predictor of 30-day mortality (HR 3.07, 95 % CI 1.01-9.41, p = 0.048), as well as baseline ejection fraction (HR 0.96, 95 % CI 0.92-0.99, p = 0.043), and acute kidney injury (HR 3.95, 95 % CI 1.11-14.05, p = 0.034). Conclusions: RBC transfusion is an independent predictor of short-term mortality in patients undergoing TA-TAVI, regardless of major bleeding.Clinical trial registration: https://www.clinicaltrials.gov Unique identifier: NCT03740425.

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BACKGROUND: Vasopressor test (VPT) might be useful in patients with functional mitral regurgitation (MR) and left ventricular dysfunction (MITRA-FR-like patients) during transcatheter edge-to-edge repair (TEER). AIMS: We aimed to evaluate the prognostic impact of VPT. METHODS: MR treated with TEER were included in a multicenter prospective registry. VPT was used intraprocedurally in patients with left ventricular dysfunction and/or hypotension. The 1-year echocardiographic and clinical outcomes were compared according to the use of VPT. The primary endpoint was a combination of mortality + heart failure (HF) readmission at 1-year. RESULTS: A total of 1115 patients were included, mean age was 72.8 ± 10.5 years and 30.4% were women. VPT was performed in 128 subjects (11.5%), more often in critically ill patients with biventricular dysfunction. Postprocedurally the VPT group had greater rate of MR ≥ 2+ (46.9% vs. 31.7%, p = 0.003) despite greater number of devices (≥2 clips, 52% vs. 40.6 p = 0.008) and device repositioning or new clip in 12.5%. At 1-year, the primary endpoint occurred more often in the VPT group (27.3% vs. 16.9%, p = 0.002) as well as all-cause mortality (21.9% vs. 8.1%, p ≤ 0.001) but no differences existed in HF readmission rate (14.8% vs. 13.2%, p = 0.610), cardiovascular mortality (4.4% vs. 3.9%, p = 0.713) or residual MR ≥ 2+ (51.1% vs 51.7%, p = 0.371). CONCLUSIONS: Dynamic evaluation of MR during TEER procedure through VPT was performed in patients with worse baseline risk who also presented higher all-cause mortality at 1-year follow-up. However, 1-year residual MR, cardiovascular mortality and HF readmission rate remained comparable suggesting that VPT might help in the management of MITRA-FR-like patients.

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Cateterismo Cardíaco , Insuficiencia de la Válvula Mitral , Válvula Mitral , Readmisión del Paciente , Valor Predictivo de las Pruebas , Sistema de Registros , Función Ventricular Izquierda , Humanos , Insuficiencia de la Válvula Mitral/fisiopatología , Insuficiencia de la Válvula Mitral/diagnóstico por imagen , Insuficiencia de la Válvula Mitral/mortalidad , Insuficiencia de la Válvula Mitral/cirugía , Femenino , Anciano , Masculino , Resultado del Tratamiento , Factores de Tiempo , Cateterismo Cardíaco/efectos adversos , Cateterismo Cardíaco/instrumentación , Estudios Prospectivos , Anciano de 80 o más Años , Factores de Riesgo , Válvula Mitral/fisiopatología , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/cirugía , Persona de Mediana Edad , Vasoconstrictores/uso terapéutico , Disfunción Ventricular Izquierda/fisiopatología , Disfunción Ventricular Izquierda/mortalidad , Disfunción Ventricular Izquierda/diagnóstico por imagen , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Implantación de Prótesis de Válvulas Cardíacas/mortalidad , Insuficiencia Cardíaca/fisiopatología , Insuficiencia Cardíaca/mortalidad , Insuficiencia Cardíaca/diagnóstico , Recuperación de la Función , Medición de Riesgo , Hemodinámica

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Background/Objectives: To date, data regarding the characteristics and management of obstructive, stable coronary artery disease (CAD) encountered in patients undergoing transcatheter aortic valve implantation (TAVI) are sparse. The aim of the study was to analyze granular details, treatment, and outcomes of patients undergoing TAVI with obstructive, stable CAD from real-world practice. Methods: REVASC-TAVI (Management of myocardial REVASCularization in patients undergoing Transcatheter Aortic Valve Implantation with coronary artery disease) is an investigator-initiated, multicenter registry, which collected data from patients undergoing TAVI with obstructive stable CAD found during the pre-TAVI work-up. Results: A total of 2025 patients from 30 centers worldwide with complete follow-up were included in the registry. Most patients had single-vessel CAD (56.1%). An involvement of proximal coronary tracts was detected in 62.5% of cases, with 12.0% of patients having CAD in left main (LM). Most patients received percutaneous coronary intervention (PCI) (n = 1617, 79.9%), especially those with proximal CAD (90.4%). At 2 years, the rates of all-cause death [Kaplan-Meier (KM) estimates 20.1% vs. 18.8%, plog-rank = 0.86] and of the composite of all-cause death, stroke, myocardial infarction, and rehospitalization for heart failure (KM estimates 29.7% vs. 27.5%, plog-rank = 0.82) did not differ between patients undergoing PCI and those who were not. Conclusions: Patients undergoing TAVI with obstructive CAD more commonly had a single-vessel disease and an involvement of proximal coronary tracts. They were commonly treated with PCI, with similar outcomes compared to those treated conservatively.

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AIMS: Haemodynamic monitoring using implantable pressure sensors reduces the risk of heart failure (HF) hospitalizations. Patient self-management (PSM) of haemodynamics in HF has the potential to personalize treatment, increase adherence, and reduce the risk of worsening HF, while lowering clinicians' burden. METHODS AND RESULTS: The VECTOR-HF I and IIa studies are prospective, single-arm, open-label clinical trials assessing safety, usability and performance of left atrial pressure (LAP)-guided HF management using PSM in New York Heart Association class II and III HF patients. Physician-prescribed LAP thresholds trigger patient self-adjustment of diuretics. Primary endpoints include the ability to perform LAP measurements and transmit data to the healthcare provider (HCP) interface and the patient guidance application, and safety outcomes. This is an interim analysis of 13 patients using the PSM approach. Over 12 months, no procedure- or device-related major adverse cardiovascular or neurological events were observed, and there were no failures to obtain measurements from the sensor and transmit the data to the HCP interface and the patient guidance application. Patient adherence was 91.4%. Using PSM, annualized HF hospitalization rate significantly decreased compared to a similar period prior to PSM utilization (0 admissions vs. 0.69 admissions over 11.84 months, p = 0.004). At 6 months, 6-min walk test distance and the Kansas City Cardiomyopathy Questionnaire overall summary score demonstrated significant improvement. CONCLUSIONS: Interim findings suggest that PSM using a LAP monitoring system is feasible and safe. PSM is associated with high patient adherence, potentially improving HF patients' functional status, quality of life, and limiting HF hospitalizations.

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Presión Atrial , Insuficiencia Cardíaca , Automanejo , Humanos , Insuficiencia Cardíaca/terapia , Insuficiencia Cardíaca/fisiopatología , Masculino , Femenino , Anciano , Estudios Prospectivos , Automanejo/métodos , Presión Atrial/fisiología , Persona de Mediana Edad , Hospitalización/estadística & datos numéricos

RESUMEN

BACKGROUND: The role of quantitative flow ratio (QFR) in the treatment of nonculprit vessels of patients with myocardial infarction (MI) is a topic of ongoing discussion. OBJECTIVES: This study aimed to investigate the predictive capability of QFR for adverse events and its noninferiority compared to wire-based functional assessment in nonculprit vessels of MI patients. METHODS: The FIRE (Functional Assessment in Elderly MI Patients With Multivessel Disease) trial randomized 1,445 older MI patients to culprit-only (n = 725) or physiology-guided complete revascularization (n = 720). In the culprit-only arm, angiographic projections of nonculprit vessels were prospectively collected, centrally reviewed for QFR computation, and associated with endpoints. In the complete revascularization arm, endpoints were compared between nonculprit vessels investigated with QFR or wire-based functional assessment. The primary endpoint was the vessel-oriented composite endpoint (VOCE) at 1 year. RESULTS: QFR was measured on 903 nonculprit vessels from 685 patients in the culprit-only arm. Overall, 366 (40.5%) nonculprit vessels showed a QFR value ≤0.80, with a significantly higher incidence of VOCEs (22.1% vs 7.1%; P < 0.001). QFR ≤0.80 emerged as an independent predictor of VOCEs (HR: 2.79; 95% CI: 1.64-4.75). In the complete arm, QFR was used in 320 (35.2%) nonculprit vessels to guide revascularization. When compared with propensity-matched nonculprit vessels in which treatment was guided by wire-based functional assessment, no significant difference was observed (HR: 0.57; 95% CI: 0.28-1.15) in VOCEs. CONCLUSIONS: This prespecified subanalysis of the FIRE trial provides evidence supporting the safety and efficacy of QFR-guided interventions for the treatment of nonculprit vessels in MI patients. (Functional Assessment in Elderly MI Patients With Multivessel Disease [FIRE]; NCT03772743).

Asunto(s)

Angiografía Coronaria , Intervención Coronaria Percutánea , Valor Predictivo de las Pruebas , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Cateterismo Cardíaco/efectos adversos , Cateterismo Cardíaco/instrumentación , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/fisiopatología , Vasos Coronarios/diagnóstico por imagen , Vasos Coronarios/fisiopatología , Reserva del Flujo Fraccional Miocárdico , Infarto del Miocardio/fisiopatología , Infarto del Miocardio/diagnóstico por imagen , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/instrumentación , Estudios Prospectivos , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento

RESUMEN

BACKGROUND Transcatheter aortic valve implantation is an established, guideline-endorsed treatment for severe aortic stenosis. Precise sizing of the balloon-expandable Myval transcatheter heart valve (THV) series with the aortic annulus is facilitated by increasing its diameter in 1•5 mm increments, compared with the usual 3 mm increments in valve size. The LANDMARK trial aimed to show non-inferiority of the Myval THV series compared with the contemporary THVs Sapien Series (Edwards Lifesciences, Irvine, CA, USA) or Evolut Series (Medtronic, Minneapolis, MN, USA). METHODS In this prospective, multinational, randomised, open-label, non-inferiority trial across 31 hospitals in 16 countries (Germany, France, Sweden, the Netherlands, Italy, Spain, New Zealand, Portugal, Greece, Hungary, Poland, Slovakia, Slovenia, Croatia, Estonia, and Brazil), 768 participants with severe symptomatic native aortic stenosis were randomly assigned (1:1) to the Myval THV or a contemporary THV. Eligibility was primarily decided by the heart team in accordance with 2021 European Society of Cardiology guidelines. As per the criteria of the third Valve Academic Research Consortium, the primary endpoint at 30 days was a composite of all-cause mortality, all stroke, bleeding (types 3 and 4), acute kidney injury (stages 2­4), major vascular complications, moderate or severe prosthetic valve regurgitation, and conduction system disturbances resulting in a permanent pacemaker implantation. Non-inferiority of the study device was tested in the intention-to-treat population using a non-inferiority margin of 10•44% and assuming an event rate of 26•10%. This trial is registered with ClinicalTrials.gov, NCT04275726, and EudraCT, 2020-000137-40, and is closed to new participants. FINDINGS Between Jan 6, 2021, and Dec 5, 2023, 768 participants with severe symptomatic native aortic stenosis were randomly assigned, 384 to the Myval THV and 384 to a contemporary THV. 369 (48%) participants had their sex recorded as female, and 399 (52%) as male. The mean age of participants was 80•0 years (SD 5•7) for those treated with the Myval THV and 80•4 years (5•4) for those treated with a contemporary THV. Median Society of Thoracic Surgeons scores were the same in both groups (Myval 2•6% [IQR 1•7­4•0] vs contemporary 2•6% [1•7­4•0]). The primary endpoint showed non-inferiority of the Myval (25%) compared with contemporary THV (27%), with a risk difference of ­2•3% (one-sided upper 95% CI 3•8, pnon-inferiority<0•0001). No significant difference was seen in individual components of the primary composite endpoint. INTERPRETATION In individuals with severe symptomatic native aortic stenosis, the Myval THV met its primary endpoint at 30 days.

RESUMEN

BACKGROUND: Transcatheter aortic valve implantation is an established, guideline-endorsed treatment for severe aortic stenosis. Precise sizing of the balloon-expandable Myval transcatheter heart valve (THV) series with the aortic annulus is facilitated by increasing its diameter in 1·5 mm increments, compared with the usual 3 mm increments in valve size. The LANDMARK trial aimed to show non-inferiority of the Myval THV series compared with the contemporary THVs Sapien Series (Edwards Lifesciences, Irvine, CA, USA) or Evolut Series (Medtronic, Minneapolis, MN, USA). METHODS: In this prospective, multinational, randomised, open-label, non-inferiority trial across 31 hospitals in 16 countries (Germany, France, Sweden, the Netherlands, Italy, Spain, New Zealand, Portugal, Greece, Hungary, Poland, Slovakia, Slovenia, Croatia, Estonia, and Brazil), 768 participants with severe symptomatic native aortic stenosis were randomly assigned (1:1) to the Myval THV or a contemporary THV. Eligibility was primarily decided by the heart team in accordance with 2021 European Society of Cardiology guidelines. As per the criteria of the third Valve Academic Research Consortium, the primary endpoint at 30 days was a composite of all-cause mortality, all stroke, bleeding (types 3 and 4), acute kidney injury (stages 2-4), major vascular complications, moderate or severe prosthetic valve regurgitation, and conduction system disturbances resulting in a permanent pacemaker implantation. Non-inferiority of the study device was tested in the intention-to-treat population using a non-inferiority margin of 10·44% and assuming an event rate of 26·10%. This trial is registered with ClinicalTrials.gov, NCT04275726, and EudraCT, 2020-000137-40, and is closed to new participants. FINDINGS: Between Jan 6, 2021, and Dec 5, 2023, 768 participants with severe symptomatic native aortic stenosis were randomly assigned, 384 to the Myval THV and 384 to a contemporary THV. 369 (48%) participants had their sex recorded as female, and 399 (52%) as male. The mean age of participants was 80·0 years (SD 5·7) for those treated with the Myval THV and 80·4 years (5·4) for those treated with a contemporary THV. Median Society of Thoracic Surgeons scores were the same in both groups (Myval 2·6% [IQR 1·7-4·0] vs contemporary 2·6% [1·7-4·0]). The primary endpoint showed non-inferiority of the Myval (25%) compared with contemporary THV (27%), with a risk difference of -2·3% (one-sided upper 95% CI 3·8, pnon-inferiority<0·0001). No significant difference was seen in individual components of the primary composite endpoint. INTERPRETATION: In individuals with severe symptomatic native aortic stenosis, the Myval THV met its primary endpoint at 30 days. FUNDING: Meril Life Sciences.

Asunto(s)

Estenosis de la Válvula Aórtica , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/cirugía , Complicaciones Posoperatorias/epidemiología , Estudios Prospectivos , Diseño de Prótesis , Índice de Severidad de la Enfermedad , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Resultado del Tratamiento

RESUMEN

BACKGROUND: Optimal strategies to manage embolization of transcatheter aortic valve implantation (TAVI) devices are unclear; valve-in-valve (ViV) is often used. We aimed to describe through one-single center experience its rate, causes, consequences, and management as well as the rate and relevance of commissural alignment (CA) in this context. METHODS: We identified across 1038 TAVI cases, those cases requiring ViV for the management of first device embolization. CA (absence or mild misalignment) after first and second device was assessed by CT or fluoroscopy. RESULTS: A total of 23 cases (2.2%) were identified, 52.3% embolized towards the aorta and 47.7% towards the ventricle. Suboptimal implant height (38%) and embolization at the time of post-dilation (23%) were the most frequent mechanisms together with greater rate of bicuspid valve (p < 0.001) and a trend to greater annular eccentricity. Procedural and 1-year death occurred in 13% and 34%, respectively (vs. 1.1% and 7.8% in the global cohort, p < 0.001). CA was present in 76.9% of the prostheses initially implanted but was only spontaneously achieved in 30.8% of the second ViV device. Adequate CA of both prostheses was identified in only two cases (8.7%). There were no cases of coronary obstruction. CONCLUSIONS: TAVI device embolization mechanisms can often be predicted and prevented. Mortality following bail-out ViV is higher than in regular TAVI procedures but 2/3 of these patients survived beyond 1-year follow-up. In them, valve degeneration or coronary re-access might be particularly challenging since CA was rarely achieved with both devices suggesting that greater efforts should be made in this regard.

Asunto(s)

Estenosis de la Válvula Aórtica , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Masculino , Femenino , Anciano , Anciano de 80 o más Años , Resultado del Tratamiento , Estenosis de la Válvula Aórtica/cirugía , Estudios Retrospectivos , Estudios de Seguimiento , Diseño de Prótesis , Embolia/etiología , Válvula Aórtica/cirugía , Válvula Aórtica/diagnóstico por imagen

RESUMEN

A data-driven reduced order model (ROM) based on a proper orthogonal decomposition-radial basis function (POD-RBF) approach is adopted in this paper for the analysis of blood flow dynamics in a patient-specific case of atrial fibrillation (AF). The full order model (FOM) is represented by incompressible Navier-Stokes equations, discretized with a finite volume (FV) approach. Both the Newtonian and the Casson's constitutive laws are employed. The aim is to build a computational tool able to efficiently and accurately reconstruct the patterns of relevant hemodynamics indices related to the stasis of the blood in a physical parametrization framework including the cardiac output in the Newtonian case and also the plasma viscosity and the hematocrit in the non-Newtonian one. Many FOM-ROM comparisons are shown to analyze the performance of our approach as regards errors and computational speed-up.

Asunto(s)

Fibrilación Atrial , Atrios Cardíacos , Modelos Cardiovasculares , Fibrilación Atrial/fisiopatología , Humanos , Atrios Cardíacos/fisiopatología , Hemodinámica , Simulación por Computador , Velocidad del Flujo Sanguíneo