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BACKGROUND: Tricuspid regurgitation (TR) is a common valve disease that has a significant impact on patients' quality of life. OBJECTIVES: This study sought to report the final 3-year outcomes of tricuspid transcatheter edge-to-edge repair (T-TEER) with the TriClip (Abbott) implant from the TRILUMINATE (TRILUMINATE Study With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater TR) study for the treatment of severe symptomatic TR. METHODS: The TRILUMINATE study (N = 98 subjects) is an international, prospective, single-arm, multicenter study to investigate the safety and performance of T-TEER with the TriClip implant in patients with symptomatic moderate or greater TR. Echocardiographic assessments were performed at a core laboratory. RESULTS: At 3 years, TR was reduced to moderate or less in 79% of subjects, and a reduction of at least 1 grade was achieved in 92% of subjects. TR reduction achieved at 1 year was sustained through 3 years. Subjects also experienced an improvement in heart failure symptoms assessed by NYHA functional class and quality of life assessed by the Kansas City Cardiomyopathy Questionnaire at 3 years compared to baseline. The site-reported heart failure hospitalization rate decreased from 0.43 events/patient-year 1 year before device implantation to 0.06 events/patient-year 1 year after device implantation, representing a reduction of 86% (P < 0.0001). CONCLUSIONS: In the longest follow-up to date of any T-TEER therapy, the TRILUMINATE study demonstrated that the TriClip procedure is both safe and effective, with sustained benefits at 3 years in subjects with symptomatic moderate or greater TR. (TRILUMINATE Study With Abbott Transcatheter Clip Repair System in Patients With Moderate or Greater TR [TRILUMINATE]; NCT03227757).
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Background: Although pulmonary embolism (PE) and sarcopenia are common diseases, only a few studies have assessed the impact of sarcopenia in PE on usage of reperfusion treatments in PE. Methods: All hospitalizations of PE patients aged ≥75 years 2005-2020 in Germany were included in this study and stratified for sarcopenia. Impact of sarcopenia on treatment procedures and adverse in-hospital events were investigated. Results: Overall, 576,364 hospitalizations of PE patients aged ≥75 years (median age 81.0 [78.0-85.0] years; 63.3 % females) were diagnosed in Germany during the observational period 2005-2020. Among these, 2357 (0.4 %) were coded with sarcopenia. PE patients with sarcopenia were in median 2 years older (83.0 [79.0-87.0] vs. 81.0 [78.0-85.0] years, P<0.001) and showed an aggravated comorbidity-profile (Charlson Comorbidity Index 7.00 [5.00-9.00] vs. 6.00 [4.00-7.00], P<0.001). Although signs of hemodynamic compromise such as shock (5.2 % vs. 4.1 %, P=0.005) and tachycardia (4.1 % vs. 2.8 %, P<0.001) were more prevalent in sarcopenic PE patients, systemic thrombolysis (1.9 % vs. 3.5 %, P<0.001) was less often used in these patients. Sarcopenia was independently related to an underuse of systemic thrombolysis (OR 0.537 [95 %CI 0.398-0.725], P<0.001). This underuse might driven by higher rates of bleeding events (gastro-intestinal bleeding: 3.1 % vs. 1.9 %, P<0.001, necessity of transfusion of blood constituents: 18.9 % vs. 11.3 %, P<0.001), but also stroke (5.6 % vs. 3.3 %, P<0.001). Conclusions: Sarcopenia represents a widely overlooked condition in PE patients. Although sarcopenic PE patients were more often afflicted by hemodynamic compromise, systemic thrombolysis was less often administered. This underuse might be caused by contraindications like bleeding events and stroke.
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AIMS: Transcatheter tricuspid valve interventions (TTVI) are increasingly used to treat patients with significant tricuspid regurgitation (TR). The evolution of concurrent mitral regurgitation (MR) severity after TTVI is currently unknown and may be pivotal for clinical decision-making. The aim of this study was to assess the evolution of MR after TTVI and to identify predictors of MR worsening and improvement. METHODS AND RESULTS: This analysis is a substudy of the Trivalve Registry, an international registry designed to collect data on TTVI. This substudy included all patients with echocardiographic data on MR evolution and excluded those with a concomitant tricuspid and mitral transcatheter valve intervention or with a history of mitral valve intervention. The co-primary outcomes were MR improvement and worsening at two timepoints: pre-discharge and 2-month follow-up. This analysis included 359 patients with severe TR, mostly(80%) treated with tricuspid transcatheter edge-to-edge repair(T-TEER). MR improvement was found in 106(29.5%) and 99(34%) patients, while MR worsening in 34(9.5%) and 33(11%) patients at pre-discharge and 2-month follow-up, respectively. Annuloplasty and heterotopic replacement were associated with MR worsening. Independent predictors of MR improvement were: atrial fibrillation, T-TEER, acute procedural success, TR reduction, LVEDD>60 mm and beta-blocker therapy. Patients with moderate-to-severe/severe MR following TTVI showed significantly higher death rates. CONCLUSION: MR degree variation is common after TTVI, with most cases showing improvement. Clinical and procedural characteristics may predict the MR evolution, in particular procedural success and T-TEER play key roles in MR outcomes. TTVI may be beneficial even in the presence of functional MR.
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BACKGROUND: Current treatment recommendations for patients with heart failure and secondary mitral regurgitation include transcatheter edge-to-edge repair and mitral-valve surgery. Data from randomized trials comparing these therapies are lacking in this patient population. METHODS: In this noninferiority trial conducted in Germany, patients with heart failure and secondary mitral regurgitation who continued to have symptoms despite guideline-directed medical therapy were randomly assigned, in a 1:1 ratio, to undergo either transcatheter edge-to-edge repair (intervention group) or surgical mitral-valve repair or replacement (surgery group). The primary efficacy end point was a composite of death, hospitalization for heart failure, mitral-valve reintervention, implantation of an assist device, or stroke within 1 year after the procedure. The primary safety end point was a composite of major adverse events within 30 days after the procedure. RESULTS: A total of 210 patients underwent randomization. The mean (±SD) age of the patients was 70.5±7.9 years, 39.9% were women, and the mean left ventricular ejection fraction was 43.0±11.7%. Within 1 year, at least one of the components of the primary efficacy end point occurred in 16 of the 96 patients with available data (16.7%) in the intervention group and in 20 of the 89 with available data (22.5%) in the surgery group (estimated mean difference, -6 percentage points; 95% confidence interval [CI], -17 to 6; P<0.001 for noninferiority). A primary safety end-point event occurred in 15 of the 101 patients with available data (14.9%) in the intervention group and in 51 of the 93 patients with available data (54.8%) in the surgery group (estimated mean difference, -40 percentage points; 95% CI, -51 to -27; P<0.001). CONCLUSIONS: Among patients with heart failure and secondary mitral regurgitation, transcatheter edge-to-edge repair was noninferior to mitral-valve surgery with respect to a composite of death, rehospitalization for heart failure, stroke, reintervention, or implantation of an assist device in the left ventricle at 1 year. (Funded by Abbott Vascular; MATTERHORN ClinicalTrials.gov number, NCT02371512.).
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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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A 66-year-old woman with a complex medical history underwent transcatheter mitral valve replacement (TMVI) owing to mitral insufficiency. Risk factors and noncompliance led to bioprosthetic valve thrombosis (BPVT) within 3 years. Emergent surgery indicated by an ad hoc heart team successfully managed the situation, showcasing challenges in BPVT management after TMVI.
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Transesophageal echocardiography (TEE) is widely used in cardiac surgery and interventional cardiology and is often an indispensable tool, giving supportive anatomical understanding and smooth guidance in both settings. Despite it being considered safe, fatal complications can commonly occur after a TEE examination in cardiac surgery operating rooms and catheterization laboratories. Currently, there is a lack of awareness of the scale of the problem, as there are only small amounts of data available, mainly derived from the surgical literature. This review summarizes the main predisposing factors for TEE-associated complications (classified as patient and procedure-related) and the main preventive strategies. We aim to apply preventive strategies more broadly, especially to patients at high risk of developing TEE-related serious adverse events.
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Background/Objectives: Previous trials reported comparable results with PASCAL and earlier MitraClip generations. Limited comparative data exist for more contemporary MitraClip generations, particularly the large MitraClip XT(R/W). We aimed to evaluate acute and 30-day outcomes in patients undergoing mitral valve transcatheter edge-to-edge repair (M-TEER) with one of the large devices, either PASCAL P10 or MitraClip XT(R/W) (3rd/4th generation). Methods: A total of 309 PASCAL-treated patients were matched by propensity score to 253 MitraClip-treated patients, resulting in 200 adequately balanced pairs. Procedural, clinical, and echocardiographic outcomes were collected for up to 30 days, including subgroup analysis for mitral regurgitation (MR) etiologies. Results: PASCAL and MitraClip patients were comparable regarding age (80 vs. 79 years), sex (female: 45.5% vs. 50.5%), and MR etiology (degenerative MR: n = 94, functional MR [FMR]: n = 96, mixed MR: n = 10 in each group). Technical success rates were comparable (96.5% vs. 96.0%; p > 0.999). At discharge, the mean gradient was higher (3.3 mmHg vs. 3.0 mmHg; p = 0.038), and the residual mitral valve orifice area was smaller in MitraClip patients (3.0 cm2 vs. 2.3 cm2; p < 0.001). At discharge, the reduction to MR ≤ 2+ was comparable (92.4% vs. 87.8%; p = 0.132). However, reduction to MR ≤ 1+ was more frequently observed in PASCAL patients (67.7% vs. 56.6%; p = 0.029), driven by the FMR subgroup (74.0% vs. 60.0%; p = 0.046). No difference was observed in 30-day mortality (p = 0.204) or reduction in NYHA-FC to ≤II (p > 0.999). Conclusions: Both M-TEER devices exhibited high and comparable rates of technical success and MR reduction to ≤2+. PASCAL may be advantageous in achieving MR reduction to ≤1+ in patients with FMR.
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INTRODUCTION: The exposome concept includes nutrition as it significantly influences human health, impacting the onset and progression of diseases. Gluten-containing wheat products are an essential source of energy for the world's population. However, a rising number of non-celiac healthy individuals tend to reduce or completely avoid gluten-containing cereals for health reasons. AIM AND METHODS: This prospective interventional human study aimed to investigate whether short-term gluten avoidance improves cardiovascular endpoints and quality of life (QoL) in healthy volunteers. A cohort of 27 participants followed a strict gluten-free diet (GFD) for four weeks. Endothelial function measured by flow-mediated vasodilation (FMD), blood testing, plasma proteomics (Olink®) and QoL as measured by the World Health Organisation Quality-of-Life (WHOQOL) survey were investigated. RESULTS: GFD resulted in decreased leucocyte count and C-reactive protein levels along with a trend of reduced inflammation biomarkers determined by plasma proteomics. A positive trend indicated improvement in FMD, whereas other cardiovascular endpoints remained unchanged. In addition, no improvement in QoL was observed. CONCLUSION: In healthy individuals, a short-term GFD demonstrated anti-inflammatory effects but did not result in overall cardiovascular improvement or enhanced quality of life.
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Biomarcadores , Dieta Sin Gluten , Calidad de Vida , Humanos , Masculino , Estudios Prospectivos , Femenino , Biomarcadores/sangre , Adulto , Persona de Mediana Edad , Enfermedades Cardiovasculares/prevención & control , Voluntarios Sanos , Proteína C-Reactiva/análisis , Proteína C-Reactiva/metabolismo , Vasodilatación , Adulto JovenRESUMEN
BACKGROUND: Activation of the immune system contributes to cardiovascular diseases. The role of human-specific long noncoding RNAs in cardioimmunology is poorly understood. METHODS: Single-cell sequencing in peripheral blood mononuclear cells revealed a novel human-specific long noncoding RNA called HEAT4 (heart failure-associated transcript 4). HEAT4 expression was assessed in several in vitro and ex vivo models of immune cell activation, as well as in the blood of patients with heart failure (HF), acute myocardial infarction, or cardiogenic shock. The transcriptional regulation of HEAT4 was verified through cytokine treatment and single-cell sequencing. Loss-of-function and gain-of-function studies and multiple RNA-protein interaction assays uncovered a mechanistic role of HEAT4 in the monocyte anti-inflammatory gene program. HEAT4 expression and function was characterized in a vascular injury model in NOD.CB17-Prkdc scid/Rj mice. RESULTS: HEAT4 expression was increased in the blood of patients with HF, acute myocardial infarction, or cardiogenic shock. HEAT4 levels distinguished patients with HF from people without HF and predicted all-cause mortality in a cohort of patients with HF over 7 years of follow-up. Monocytes, particularly anti-inflammatory CD16+ monocytes, which are increased in patients with HF, are the primary source of HEAT4 expression in the blood. HEAT4 is transcriptionally activated by treatment with anti-inflammatory interleukin-10. HEAT4 activates anti-inflammatory and inhibits proinflammatory gene expression. Increased HEAT4 levels result in a shift toward more CD16+ monocytes. HEAT4 binds to S100A9, causing a monocyte subtype switch, thereby reducing inflammation. As a result, HEAT4 improves endothelial barrier integrity during inflammation and promotes vascular healing after injury in mice. CONCLUSIONS: These results characterize a novel endogenous anti-inflammatory pathway that involves the conversion of monocyte subtypes into anti-inflammatory CD16+ monocytes. The data identify a novel function for the class of long noncoding RNAs by preventing protein secretion and suggest long noncoding RNAs as potential targets for interventions in the field of cardioimmunology.
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BACKGROUND: The REDUCE LAP-HF II (Reduce Elevated Left Atrial Pressure in Patients With Heart Failure II) trial found that, compared with a sham procedure, the Corvia Atrial Shunt did not improve outcomes in heart failure with preserved or mildly reduced ejection fraction. However, after 12-month follow-up, "responders" (peak-exercise pulmonary vascular resistance <1.74 WU and absence of a cardiac rhythm management device) were identified. OBJECTIVES: This study sought to determine: 1) the overall efficacy and safety of the atrial shunt vs sham control after 2 years of follow-up; and 2) whether the benefits of atrial shunting are sustained in responders during longer-term follow-up or are offset by adverse effects of the shunt. METHODS: The study analyzed 2-year outcomes in the overall REDUCE LAP-HF II trial, as well as in responder and nonresponder subgroups. The primary endpoint was a hierarchical composite of cardiovascular death or nonfatal ischemic/embolic stroke, total heart failure events, and change in health status. RESULTS: In 621 randomized patients, there was no difference between the shunt (n = 309) and sham (n = 312) groups in the primary endpoint (win ratio: 1.01 [95% CI: 0.82-1.24]) or its individual components at 2 years. Shunt patency at 24 months was 98% in shunt-treated patients. Cardiovascular mortality and nonfatal ischemic stroke were not different between the groups; however, major adverse cardiac events were more common in those patients assigned to the shunt compared with sham (6.9% vs 2.7%; P = 0.018). More patients randomized to the shunt had an increase in right ventricular volume of ≥30% compared with the sham control (39% vs 28%, respectively; P < 0.001), but right ventricular dysfunction was uncommon and not different between the treatment groups. In responders (n = 313), the shunt was superior to sham (win ratio: 1.36 [95% CI: 1.02-1.83]; P = 0.037, with 51% fewer HF events [incidence rate ratio: 0.49 [95% CI: 0.25-0.95]; P = 0.034]). In nonresponders (n = 265), atrial shunting was inferior to sham (win ratio: 0.73 [95% CI: 0.54-0.98]). CONCLUSIONS: At 2 years of follow-up in REDUCE LAP-HF II, there was no difference in efficacy between the atrial shunt and sham groups in the overall trial group. The potential clinical benefit identified in the responder group after 1 and 2 years of follow-up is currently being evaluated in the RESPONDER-HF (Re-Evaluation of the Corvia Atrial Shunt Device in a Precision Medicine Trial to Determine Efficacy in Mildly Reduced or Preserved Ejection Fraction Heart Failure) trial. (Reduce Elevated Left Atrial Pressure in Patients With Heart Failure II [REDUCE LAP-HF II]; NCT03088033).
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Atrios Cardíacos , Insuficiencia Cardíaca , Volumen Sistólico , Humanos , Insuficiencia Cardíaca/fisiopatología , Insuficiencia Cardíaca/cirugía , Insuficiencia Cardíaca/terapia , Femenino , Masculino , Volumen Sistólico/fisiología , Anciano , Persona de Mediana Edad , Atrios Cardíacos/fisiopatología , Resultado del Tratamiento , Estudios de Seguimiento , Presión Atrial/fisiologíaRESUMEN
BACKGROUND: Right ventricular impairment is common among patients undergoing transcatheter edge-to-edge repair for secondary mitral regurgitation (SMR). Adherence to guideline-directed medical therapy (GDMT) for heart failure is poor in these patients. OBJECTIVES: The aim of this study was to evaluate the impact of GDMT on long-term survival in this patient cohort. METHODS: Within the EuroSMR (European Registry of Transcatheter Repair for Secondary Mitral Regurgitation) international registry, we selected patients with SMR and right ventricular impairment (tricuspid annular plane systolic excursion ≤17 mm and/or echocardiographic right ventricular-to-pulmonary artery coupling <0.40 mm/mm Hg). Titrated guideline-directed medical therapy (GDMTtit) was defined as a coprescription of 3 drug classes with at least one-half of the target dose at the latest follow-up. The primary outcome was all-cause mortality at 6 years. RESULTS: Among 1,213 patients with SMR and right ventricular impairment, 852 had complete data on medical therapy. The 123 patients who were on GDMTtit showed a significantly higher long-term survival vs the 729 patients not on GDMTtit (61.8% vs 36.0%; P < 0.00001). Propensity score-matched analysis confirmed a significant association between GDMTtit and higher survival (61.0% vs 43.1%; P = 0.018). GDMTtit was an independent predictor of all-cause mortality (HR: 0.61; 95% CI: 0.39-0.93; P = 0.02 for patients on GDMTtit vs those not on GDMTtit). Its association with better outcomes was confirmed among all subgroups analyzed. CONCLUSIONS: In patients with right ventricular impairment undergoing transcatheter edge-to-edge repair for SMR, titration of GDMT to at least one-half of the target dose is associated with a 40% lower risk of all-cause death up to 6 years and should be pursued independent of comorbidities.
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Cateterismo Cardíaco , Fármacos Cardiovasculares , Adhesión a Directriz , Insuficiencia de la Válvula Mitral , Guías de Práctica Clínica como Asunto , Sistema de Registros , Disfunción Ventricular Derecha , Función Ventricular Derecha , Humanos , Femenino , Masculino , Insuficiencia de la Válvula Mitral/fisiopatología , Insuficiencia de la Válvula Mitral/diagnóstico por imagen , Insuficiencia de la Válvula Mitral/mortalidad , Anciano , Resultado del Tratamiento , Factores de Tiempo , Disfunción Ventricular Derecha/fisiopatología , Disfunción Ventricular Derecha/mortalidad , Disfunción Ventricular Derecha/etiología , Disfunción Ventricular Derecha/diagnóstico por imagen , Disfunción Ventricular Derecha/terapia , Factores de Riesgo , Cateterismo Cardíaco/efectos adversos , Cateterismo Cardíaco/mortalidad , Fármacos Cardiovasculares/uso terapéutico , Fármacos Cardiovasculares/efectos adversos , Europa (Continente) , Anciano de 80 o más Años , Medición de Riesgo , Ecocardiografía Transesofágica , Válvula Mitral/fisiopatología , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/cirugía , Persona de Mediana Edad , Recuperación de la FunciónRESUMEN
BACKGROUND: Myocardial infarction (MI) is an important driver of both morbidity and mortality on a global scale. Elucidating social inequalities may help to identify vulnerable groups as well as treatment imbalances and guide efforts to improve care for MI. METHODS: All hospitalized patient-cases with confirmed MI 2005-2020 in Germany were included in the study and stratified for socioeconomic or psychosocial factors (SPF) and the impact of SPF on treatment usage and adverse in-hospital events was analyzed. RESULTS: Overall, 4,409,597 hospitalizations of MI patients were included; of these, 17,297 (0.4 %) were coded with SPF. These patients were more often of female sex (49.4 % vs. 36.9 %, P<0.001), older (median 77.0 [IQR: 65.0-84.0] vs. 73.0 [62.0-81.0] years, P<0.001) and revealed an aggravated cardiovascular profile. Although SPF were independently associated with increased usage of cardiac catheterization (OR 1.174 [95 %CI 1.136-1.212]) and percutaneous coronary intervention (OR 1.167 [95 %CI 1.130-1.205]), they were accompanied by higher risk for a prolonged length of in-hospital stay >7 days (OR 1.236 [95 %CI 1.198-1.276]) and >10 days (OR 1.296 [95 %CI 1.254-1.339]). While SPF were associated with increased risk for deep venous thrombosis and/or thrombophlebitis (OR 1.634 [95 %CI 1.427-1.870]), pulmonary embolism (OR 1.337 [95 %CI 1.149-1.555]), and acute renal failure (OR 1.170 [95 %CI 1.105-1.240), these SPF were inversely associated with in-hospital case-fatality (OR 0.461 [95 %CI 0.433-0.490]). CONCLUSIONS: This study demonstrates that SPF in hospitalized MI patients have significant impacts on treatments and outcomes. Fortunately, our data did not revealed an underuse of interventional treatments in MI patients with SPF.
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Severe tricuspid regurgitation remains largely undertreated given limited treatment options. Transcatheter tricuspid valve interventions have emerged as a promising therapy for these patients, and the TRISCEND II pivotal trial is the first randomized controlled trial to evaluate transcatheter tricuspid valve replacement (TTVR). The TRISCEND II pivotal trial studies the transcatheter EVOQUE (Edwards Lifesciences, Irvine, California) tricuspid valve replacement system using a United States Food and Drug Administration Breakthrough Device Designation-a program intended to provide timely access to medical devices by speeding up development, assessment, and review. The TRISCEND II trial is a prospective, multicenter trial that randomizes patients with symptomatic severe tricuspid regurgitation to treatment with either TTVR in conjunction with optimal medical therapy or optimal medical therapy alone. The trial's novel 2-phase design evaluates 30-day safety and 6-month effectiveness end points for the first 150 patients in the initial phase and a 1-year safety and effectiveness end point for the full cohort of 400 patients in the second phase. The TRISCEND II trial's 2-phase trial design provided an opportunity for early review and led to the first commercial approval of a TTVR system. In conclusion, the design of the TRISCEND II trial will likely inform future transcatheter tricuspid device trials.
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Cateterismo Cardíaco , Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Tricúspide , Válvula Tricúspide , Humanos , Insuficiencia de la Válvula Tricúspide/cirugía , Implantación de Prótesis de Válvulas Cardíacas/métodos , Cateterismo Cardíaco/métodos , Válvula Tricúspide/cirugía , Estudios Prospectivos , Prótesis Valvulares Cardíacas , Resultado del TratamientoRESUMEN
BACKGROUND: Severe tricuspid regurgitation (TR) is known to be associated with poor quality of life and increased risk of death when left untreated. OBJECTIVES: We sought to report the 1-year clinical outcomes of subjects treated by tricuspid transcatheter edge-to-edge repair (TEER) with the TriClip system (Abbott Cardiovascular) in a contemporary real-world setting. METHODS: The bRIGHT (An Observational Real-World Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip Device) postapproval study is a prospective, single-arm, open-label, multicenter postmarket registry conducted at 26 sites in Europe, with central event adjudication and echocardiographic core-laboratory assessment. RESULTS: Enrolled subjects (n = 511) were elderly (79 ± 7 years) with significant comorbidities. A total of 88% had baseline massive or torrential TR, and 80% of subjects were in NYHA functional class III/IV. TR was reduced to moderate or less in 81% at 1 year. Significant improvements in NYHA functional class (21% to 75% I/II, P < 0.0001) and Kansas City Cardiomyopathy Questionnaire (KCCQ) score (19 ± 26-point improvement, P <0.0001) were observed at 1 year. One-year mortality was significantly lower in subjects who achieved moderate or lower TR at 30 days; however, there was no difference in mortality among subjects who achieved moderate, mild, or trace TR at 30 days. In addition to TR reduction at 30 days, baseline serum creatinine and baseline right ventricular tricuspid annular plane systolic excursion (RV TAPSE) were independently associated with mortality at 1 year (OR: 2.169; 95% CI: 1.494-3.147; P < 0.0001; OR: 0.636; 95% CI: 0.415-0.974; P = 0.0375). Mortality was not associated with baseline TR grade or with center volume. CONCLUSIONS: Tricuspid TEER using the TriClip system was safe and effective through 1 year for subjects with significant TR and advanced disease in a diverse real-world population. (An Observational Real-world Study Evaluating Severe Tricuspid Regurgitation Patients Treated With the Abbott TriClip Device [bRIGHT]; NCT04483089).
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Insuficiencia de la Válvula Tricúspide , Humanos , Insuficiencia de la Válvula Tricúspide/cirugía , Insuficiencia de la Válvula Tricúspide/mortalidad , Masculino , Femenino , Anciano , Estudios Prospectivos , Resultado del Tratamiento , Válvula Tricúspide/cirugía , Válvula Tricúspide/diagnóstico por imagen , Sistema de Registros , Anciano de 80 o más Años , Estudios de Seguimiento , Ecocardiografía , Calidad de Vida , Cateterismo Cardíaco/métodos , Europa (Continente)/epidemiología , Factores de Tiempo , Índice de Severidad de la EnfermedadRESUMEN
BACKGROUND: The safety profile of transcatheter tricuspid valve (TTV) repair techniques is well established, but residual tricuspid regurgitation (TR) remains a concern. OBJECTIVES: The authors sought to assess the impact of residual TR severity post-TTV repair on survival. METHODS: We evaluated the survival rate at 2 years of 613 patients with severe isolated functional TR who underwent TTV repair in TRIGISTRY according to the severity of residual TR at discharge using a 3-grade (mild, moderate, and severe) or 4-grade scheme (mild, mild to moderate, moderate to severe, and severe). RESULTS: Residual TR was none/mild in 33%, moderate in 52%, and severe in 15%. The 2-year adjusted survival rates significantly differed between the 3 groups (85%, 70%, and 44%, respectively; restricted mean survival time [RMST]: P = 0.0001). When the 319 patients with moderate residual TR were subdivided into mild to moderate (n = 201, 33%) and moderate to severe (n = 118, 19%), the adjusted survival rate was also significantly different between groups (85%, 80%, 55%, and 44%, respectively; RMST: P = 0.001). Survival was significantly lower in patients with moderate to severe residual TR compared to patients with mild to moderate residual TR (P = 0.006). No difference in survival rates was observed between patients with no/mild and mild to moderate residual TR (P = 0.67) or between patients with moderate to severe and severe residual TR (P = 0.96). CONCLUSIONS: The moderate residual TR group was heterogeneous and encompassed patients with markedly different clinical outcomes. Refining TR grade classification with a more granular 4-grade scheme improved outcome prediction. Our results highlight the importance of achieving a mild to moderate or lower residual TR grade during TTV repair, which could define a successful intervention.
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Cateterismo Cardíaco , Implantación de Prótesis de Válvulas Cardíacas , Índice de Severidad de la Enfermedad , Insuficiencia de la Válvula Tricúspide , Válvula Tricúspide , Humanos , Insuficiencia de la Válvula Tricúspide/diagnóstico por imagen , Insuficiencia de la Válvula Tricúspide/cirugía , Insuficiencia de la Válvula Tricúspide/fisiopatología , Insuficiencia de la Válvula Tricúspide/mortalidad , Masculino , Femenino , Válvula Tricúspide/diagnóstico por imagen , Válvula Tricúspide/cirugía , Válvula Tricúspide/fisiopatología , Anciano , Resultado del Tratamiento , Cateterismo Cardíaco/efectos adversos , Cateterismo Cardíaco/mortalidad , Cateterismo Cardíaco/instrumentación , Factores de Tiempo , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Implantación de Prótesis de Válvulas Cardíacas/instrumentación , Implantación de Prótesis de Válvulas Cardíacas/mortalidad , Factores de Riesgo , Anciano de 80 o más Años , Persona de Mediana Edad , Medición de Riesgo , Sistema de RegistrosRESUMEN
AIM: This analysis aimed to compare the clinical outcomes associated with heart failure (HF) readmissions and to identify associations with HF hospitalizations (HFH) in patients treated with the MitraClip™ NTR/XTR System in the EXPAND study. METHODS AND RESULTS: The global, real-world EXPAND study enrolled 1041 patients with primary or secondary mitral regurgitation (MR) treated with the MitraClip NTR/XTR System. Echocardiograms were analysed by an independent echocardiographic core laboratory. The study population was stratified into HFH and No-HFH groups based on the occurrence of HFH 1 year post-index procedure. Clinical outcomes including MR severity, New York Heart Association (NYHA) functional class, Kansas City Cardiomyopathy Questionnaire (KCCQ) score, and all-cause mortality were compared (HFH: n = 181; No-HFH: n = 860). Both groups achieved consistent 1-year MR reduction to ≤1+ (HFH vs. No-HFH: 87.3% vs. 89.5%, p = 0.6) and significant 1-year improvement in KCCQ scores (+16.5 vs. +22.3, p = 0.09) and NYHA functional class. However, more patients in the No-HFH group had 1-year NYHA class ≤II (HFH vs. No-HFH: 67.9% vs. 81.9%, p < 0.01). All-cause mortality at 1 year was 36.8% in the HFH group versus 10.4% in the No-HFH group (p < 0.001). The HFH rate decreased by 63% at 1 year post-M-TEER versus 1 year pre-treatment (relative risk 0.4, p < 0.001). Independent HFH associations were MR ≥2+ at discharge, HFH 1 year prior to treatment, baseline NYHA class ≥III, baseline tricuspid regurgitation ≥2+, and baseline left ventricular ejection fraction ≤40%. CONCLUSIONS: This study reports the impact of HFH on clinical outcomes post-treatment in the EXPAND study. Results demonstrate that the occurrence of HFH was associated with worse 1-year survival, and treatment with the MitraClip system substantially reduced HFH and improved patient symptoms and quality of life.
Asunto(s)
Cateterismo Cardíaco , Insuficiencia Cardíaca , Hospitalización , Insuficiencia de la Válvula Mitral , Humanos , Insuficiencia de la Válvula Mitral/cirugía , Insuficiencia de la Válvula Mitral/fisiopatología , Masculino , Femenino , Insuficiencia Cardíaca/terapia , Insuficiencia Cardíaca/cirugía , Insuficiencia Cardíaca/fisiopatología , Anciano , Cateterismo Cardíaco/métodos , Hospitalización/estadística & datos numéricos , Anciano de 80 o más Años , Resultado del Tratamiento , Ecocardiografía/métodos , Válvula Mitral/cirugía , Válvula Mitral/diagnóstico por imagen , Implantación de Prótesis de Válvulas Cardíacas/métodos , Índice de Severidad de la Enfermedad , Estudios de SeguimientoRESUMEN
AIMS: Data on the prognostic impact of residual tricuspid regurgitation (TR) after tricuspid transcatheter edge-to-edge repair (T-TEER) are scarce. The aim of this analysis was to evaluate 2-year survival and symptomatic outcomes of patients in relation to residual TR after T-TEER. METHODS AND RESULTS: Using the large European Registry of Transcatheter Repair for Tricuspid Regurgitation (EuroTR registry) we investigated the impact of residual TR on 2-year all-cause mortality and New York Heart Association (NYHA) functional class at follow-up. The study further identified predictors for residual TR ≥3+ using a logistic regression model. The study included a total of 1286 T-TEER patients (mean age 78.0 ± 8.9 years, 53.6% female). TR was successfully reduced to ≤1+ in 42.4%, 2+ in 40.0% and 3+ in 14.9% of patients at discharge, while 2.8% remained with TR ≥4+ after the procedure. Residual TR ≥3+ was an independent multivariable predictor of 2-year all-cause mortality (hazard ratio 2.06, 95% confidence interval 1.30-3.26, p = 0.002). The prevalence of residual TR ≥3+ was four times higher in patients with higher baseline TR (vena contracta >11.1 mm) and more severe tricuspid valve tenting (tenting area >1.92 cm2). Of note, no survival difference was observed in patients with residual TR ≤1+ versus 2+ (76.2% vs. 73.1%, p = 0.461). The rate of NYHA functional class ≥III at follow-up was significantly higher in patients with residual TR ≥3+ (52.4% vs. 40.5%, p < 0.001). Of note, the degree of TR reduction significantly correlated with the extent of symptomatic improvement (p = 0.012). CONCLUSIONS: T-TEER effectively reduced TR severity in the majority of patients. While residual TR ≥3+ was associated with worse outcomes, no differences were observed for residual TR 1+ versus 2+. Symptomatic improvement correlated with the degree of TR reduction.
Asunto(s)
Cateterismo Cardíaco , Sistema de Registros , Insuficiencia de la Válvula Tricúspide , Humanos , Insuficiencia de la Válvula Tricúspide/cirugía , Insuficiencia de la Válvula Tricúspide/epidemiología , Femenino , Masculino , Anciano , Cateterismo Cardíaco/métodos , Válvula Tricúspide/cirugía , Europa (Continente)/epidemiología , Pronóstico , Resultado del Tratamiento , Anciano de 80 o más Años , Estudios de Seguimiento , Implantación de Prótesis de Válvulas Cardíacas/métodos , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Tasa de Supervivencia/tendenciasRESUMEN
BACKGROUND: Even after atrial fibrillation (AF) catheter ablation, many patients still experience relevant symptom burden. The objective of the MENTAL AF trial was to determine whether app-based mental training (MT) during the 3 months following pulmonary vein isolation reduces AF-related symptoms. METHODS AND RESULTS: Patients scheduled for pulmonary vein isolation were enrolled and randomized 1:1 to either app-based MT or usual care. Of 174 patients, 76 in the MT and 75 in the usual care group were included in the final analysis. The intervention was delivered by a daily 10-minute app-based MT. The primary outcome was the intergroup difference of the mean AF6 sum score, an AF-specific questionnaire, during the 3-month study period. Secondary outcomes included quality-of-life measures such as the AFEQT (Atrial Fibrillation Effect on Quality of Life). Mean age (SD) was 61 (8.7) years and 61 (41%) were women. The mean AF6 sum score over the study period was 8.9 (6.9) points in the MT group and 12.5 (10.1) in the usual care group (P=0.011). This referred to a reduction in the AF6 sum score compared with baseline of 75% in MT and 52% for usual care (P<0.001). The change in the AFEQT Global Score was 22.6 (16.3) and 15.7 (22.1), respectively; P=0.026. CONCLUSIONS: MENTAL AF showed that app-based MT as an adjunctive treatment tool following pulmonary vein isolation was feasible. App-based MT was found to be superior to standard care in reducing AF-related symptom burden and improving health-related quality of life. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04067427.