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Importance: Approximately 40% of patients with heart failure (HF) who are eligible for cardiac resynchronization therapy (CRT) either fail to respond or are untreatable due to anatomical constraints. Objective: To assess the safety and efficacy of a novel, leadless, left ventricular (LV) endocardial pacing system for patients at high risk for a CRT upgrade or whose coronary sinus (CS) lead placement/pacing with a conventional CRT system failed. Design, Setting, and Participants: The SOLVE-CRT study was a prospective multicenter trial, enrolling January 2018 through September 2022, with follow-up in March 2023. Data were analyzed from DATE MONTH, YEAR, through DATE MONTH, YEAR. The trial combined data from an initial randomized, double-blind study (n = 108) and a subsequent single-arm part (n = 75). It took place at 36 centers across Australia, Europe, and the US. Participants were nonresponders, previously untreatable (PU), or high-risk upgrades (HRU). All participants contributed to the safety analysis. The primary efficacy analysis (n = 100) included 75 PU-HRU patients from the single-arm part and 25 PU-HRU patients from the randomized treatment arm. Interventions: Patients were implanted with the WiSE CRT System (EBR Systems) consisting of a leadless LV endocardial pacing electrode stimulated with ultrasound energy delivered by a subcutaneously implanted transmitter and battery. Main Outcomes and Measures: The primary safety end point was freedom from type I complications. The primary efficacy end point was a reduction in mean LV end systolic volume (LVESV). Results: The study included 183 participants; mean age was 68.1 (SD, 10.3) years and 141 were male (77%). The trial was terminated at an interim analysis for meeting prespecified stopping criteria. In the safety population, patients were either New York Heart Association Class II (34.6%) or III (65.4%). The primary efficacy end point was met with a 16.4% (95% CI, -21.0% to -11.7%) reduction in mean LVESV (P = .003). The primary safety end point was met with an 80.9% rate of freedom from type I complications (P < .001), which included 12 study device system events (6.6%), 5 vascular events (2.7%), 3 strokes (1.6%), and 7 cardiac perforations which mostly occurred early in the study (3.8%). Conclusions and Relevance: The SOLVE-CRT study has demonstrated that leadless LV endocardial pacing with the WiSE CRT system is associated with a reduction in LVESV in patients with HF. This novel system may represent an alternative to conventional CRT implants in some HF patient populations. Trial Registration: ClinicalTrials.gov Identifier: NCT0292203.
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Background: The number of young patients receiving ICDs or CRT-Ds has been increasing in recent decades and understanding the key characteristics of this special population is paramount to optimized patient care. Methods: The DEVICE I+II registry prospectively enrolled patients undergoing ICD/CRT-D implantation or revision from 50 German centers between 2007 and 2014 Data on patient characteristics, procedural outcome, adverse events, and mortality during the initial stay and 1-year follow-up were collected. All patients under the age of 45 years were identified and included in a comparative analysis with the remaining population. Results: A total number of 5313 patients were enrolled into the registry, of which 339 patients (6.4%) were under the age of 45 years. Mean age was 35.0 ± 8.2 vs. 67.5 ± 9.7 years, compared to older patients (≥45 years). Young patients were more likely to receive an ICD (90.9 vs. 69.9%, p < 0.001) than a CRT-D device (9.1 vs. 30.1%). Coronary artery disease was less common in younger patients (13.6 vs. 63.9%, p < 0.001), whereas hypertrophic cardiomyopathy (10.9 vs. 2.7%, p < 0.001) and primary cardiac electrical diseases (11.2 vs. 1.5%, p < 0.001) were encountered more often. Secondary preventive ICD was more common in younger patients (51.6 vs. 39.9%, p < 0.001). Among those patients, survival of sudden cardiac death (66.7 vs. 45.4%, p < 0.001) due to ventricular fibrillation (60.6 vs. 37.9%, p < 0.001) was the leading cause for admission. There were no detectable differences in postoperative complications requiring intervention (1.5 vs. 1.9%, p = 0.68) or in-hospital mortality (0.0 vs. 0.3%, p = 0.62). Median follow-up duration was 17.9 [13.4-22.9] vs. 16.9 [13.1-23.1] months (p = 0.13). In younger patients, device-associated complications requiring revision were more common (14.1 vs. 8.3%, p < 0.001) and all-cause 1-year-mortality after implantation was lower (2.9 vs. 7.3%, p = 0.003; HR 0.39, 95%CI: 0.2-0.75) than in older patients. Conclusions: Young patients < 45 years of age received defibrillator therapy more often for secondary prevention. Rates for periprocedural complications and in-hospital mortality were very low and without differences between groups. Young patients have lower mortality during follow-up but experienced a higher rate of postoperative complications requiring revision, potentially due to a more active lifestyle.
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BACKGROUND: Semi-automated software is essential for planning and prosthesis selection prior transcatheter aortic valve replacement (TAVR). Reliable data on the usability of software programs for planning a TAVR is missing. The aim of this study was to compare software programs 'Valve Assist 2' (GE Healthcare) and 3mensio 'Structural Heart' (Pie Medical Imaging) regarding usability and accuracy of prosthesis size selection in program-inexperienced users. METHODS: Thirty-one participants (n = 31) were recruited and divided into program-inexperienced users (beginners) (n = 22) and experts (n = 9). After software training, beginners evaluated 3 patient cases in 129 measurements (n = 129) using either Valve Assist 2 (n = 11) or Structural Heart (n = 11) on 2 test days (T1, T2). System Usability Scale (SUS) and ISONORM 9241/110-S (ISONORM) questionnaire were used after the test. The valve size selected by each beginner was compared with the valve size selected from expert group. RESULTS: Valve Assist 2 had higher SUS Score: median 78.75 (25th, 75th percentile: 67.50, 85.00) compared to Structural Heart: median 65.00 (25th, 75th percentile: 47.50, 73.75), (p < 0,001, r = 0.557). Also, Valve Assist 2 showed a higher ISONORM score: median 1.05 (25th, 75th percentile: - 0.19, 1.71) compared to Structural Heart with a median 0.05 (25th, 75th percentile: - 0.49, 0.13), (p = 0.036, r = 0.454). Correctly selected valve sizes were stable over time using Valve Assist 2: 72.73% to 69.70% compared to Structural Heart program: 93.94% to 40% (χ2 (1) = 21.10, p < 0.001, φ = 0.579). CONCLUSION: The study shows significant better usability scores for Valve Assist 2 compared to 3mensio Structural Heart in program-inexperienced users.
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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 , Fidelidade a Diretrizes , Insuficiência da Valva Mitral , Guias de Prática Clínica como Assunto , Sistema de Registros , Disfunção Ventricular Direita , Função Ventricular Direita , Humanos , Feminino , Masculino , Insuficiência da Valva Mitral/fisiopatologia , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/mortalidade , Idoso , Resultado do Tratamento , Fatores de Tempo , Disfunção Ventricular Direita/fisiopatologia , Disfunção Ventricular Direita/mortalidade , Disfunção Ventricular Direita/etiologia , Disfunção Ventricular Direita/diagnóstico por imagem , Disfunção Ventricular Direita/terapia , Fatores de Risco , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/mortalidade , Fármacos Cardiovasculares/uso terapêutico , Fármacos Cardiovasculares/efeitos adversos , Europa (Continente) , Idoso de 80 Anos ou mais , Medição de Risco , Ecocardiografia Transesofagiana , Valva Mitral/fisiopatologia , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Pessoa de Meia-Idade , Recuperação de Função FisiológicaRESUMO
INTRODUCTION: Acute decompensated heart failure (ADHF) is a global health problem and early detection of high-risk patients for effective treatment is important. Exhaled breath analysis and measurement of volatile organic compounds (VOCs) may be a fast and cost-effective non-invasive diagnostic and screening tool complementing measurement of cardiac biomarkers. Another technique to detect and characterize VOCs is the ion mobility spectrometry (IMS) not requiring vacuum or sample pretreatment. METHODS: This prospective controlled proof-of-concept study prospectively enrolled adult patients with severe ADHF at the University Hospital Heart Centre Brandenburg. Severe ADHF was defined as patients presenting with symptomatic acute decompensation and NTproBNP >7000â¯pg/dL. Cardiac patients with NT-proBNP 220â¯pg/dL served as control. A gas chromatography ion mobility spectrometer (GC-IMS) of the type "MultiMarkerMonitor™" from GRAUPNER medical solutions GmbH was used. Measurement was performed at T0 (within 24â¯h of admission), T1 (after 3-5â¯days) and T2 (after 8-10â¯days). RESULTS: Forty patients were enrolled in the study, 20 patients with severe ADHF and 20 control patients. In patients with severe ADHF, three clusters with significantly altered maximum peak heights were detected compared to control. There was no change in the peak height of clusters 8, 9 and 206 at the time points T1 and T2 (all pâ¯>â¯0.50). Also, NT-proBNP was stable over time (pâ¯=â¯0.247). Sixteen control patients (16/20, 80â¯%) and four with severe ADHF (4/20, 20â¯%) presented without cluster deviation. Patients with deviation in at least two clusters had longer hospital stay, 11â¯days (5.0-15.0) compared to those without deviation, 4â¯days (2.0-9.5), pâ¯=â¯0.028. CONCLUSION: Longer-term follow-up studies are needed to assess the stability and clinical significance of the identified clusters by IMS and their diagnostic and prognostic relevance.
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Biomarcadores , Testes Respiratórios , Insuficiência Cardíaca , Peptídeo Natriurético Encefálico , Compostos Orgânicos Voláteis , Humanos , Compostos Orgânicos Voláteis/análise , Masculino , Projetos Piloto , Feminino , Estudos Prospectivos , Idoso , Doença Aguda , Testes Respiratórios/métodos , Peptídeo Natriurético Encefálico/sangue , Biomarcadores/análise , Pessoa de Meia-Idade , Análise por Conglomerados , Fragmentos de Peptídeos/análise , Fragmentos de Peptídeos/sangue , Índice de Gravidade de Doença , Espectrometria de Mobilidade Iônica , Idoso de 80 Anos ou mais , Estudo de Prova de ConceitoRESUMO
AIMS: This study aims to assess the applicability of the mitral regurgitation (MR) proportionality concept in patients with atrial functional mitral regurgitation (aFMR) treated with transcatheter edge-to-edge repair (M-TEER). We hypothesized that patients with disproportionate MR (higher MR relative to left ventricular size) would exhibit different outcomes compared to those with proportionate MR, despite undergoing M-TEER. METHODS AND RESULTS: We retrospectively analysed 98 patients with aFMR from the EuroSMR registry who underwent M-TEER between 2008 and 2019. Patients met criteria for aFMR (normal indexed left ventricular end-diastolic volume [LVEDV], preserved left ventricular ejection fraction [LVEF] ≥ 50% without regional wall motion abnormalities, and structurally normal mitral valves). We excluded patients with missing effective regurgitant orifice area (EROA) or LVEDV data. The primary endpoint was 2-year mortality, with an EROA/LVEDV ratio employed to differentiate disproportionate from proportionate MR. Procedural success and baseline characteristics were analysed, and multivariate Cox proportional hazards models were used to identify mortality predictors. The mean patient age was 79 ± 7.3 years, with 68.8% female, and 79% had a history of atrial fibrillation. The mean EROA was 0.27 ± 0.14 cm2, and LVEDV was 95.6 ± 33.7 mL. Disproportionate MR was identified with an EROA/LVEDV ratio >0.339 cm2/100 mL. While procedural success was similar in both groups, disproportionate MR was associated with a numerically higher estimate of systolic pulmonary artery pressures (sPAP) and rates of NYHA ≥III and TR ≥ 3+. Disproportionate MR had a significant association with increased 2-year mortality (P < 0.001). The EROA/LVEDV ratio and tricuspid annular plane systolic excursion (TAPSE) were independent predictors of 2-year mortality (EROA/LVEDV: HR: 1.35, P = 0.010; TAPSE: HR: 0.85, P = 0.020). CONCLUSIONS: This analysis introduces the MR proportionality concept in aFMR patients and its potential prognostic value. Paradoxically, disproportionate MR in aFMR was linked to a 1.35-fold increase in 2-year mortality post-M-TEER, emphasizing the importance of accurate preprocedural FMR characterization. Our findings in patients with disproportionate MR indicate that a high degree of aFMR with high regurgitant volumes may lead to aggravated symptoms, which is a known contributor to increased mortality following M-TEER. These results underline the need for further research into the pathophysiology of aFMR to inform potential preventative and therapeutic strategies, ensuring optimal patient outcomes.
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Cateterismo Cardíaco , Átrios do Coração , Insuficiência da Valva Mitral , Valva Mitral , Humanos , Insuficiência da Valva Mitral/fisiopatologia , Insuficiência da Valva Mitral/cirurgia , Insuficiência da Valva Mitral/diagnóstico , Feminino , Masculino , Estudos Retrospectivos , Idoso , Cateterismo Cardíaco/métodos , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Valva Mitral/fisiopatologia , Átrios do Coração/fisiopatologia , Átrios do Coração/diagnóstico por imagem , Taxa de Sobrevida/tendências , Seguimentos , Volume Sistólico/fisiologia , Função Ventricular Esquerda/fisiologia , Sistema de Registros , Ecocardiografia Transesofagiana/métodosRESUMO
INTRODUCTION: Left atrial (LA) low voltage areas (LVA) are a controversial target in atrial fibrillation ablation procedures. However, LVA and LA volume are good predictors of arrhythmia recurrence in ablation-naïve patients. Their predictive value in progressively diseased pre-ablated atria is uncertain. METHODS: Consecutive patients with recurrent atrial fibrillation (AF) or atrial tachycardia (AT), who were scheduled for repeat LA ablation, were enrolled in the prospective Bernau ablation registry between 2016 and 2020. All patients received a complete LA ultrahigh-density map before ablation. Maps were analyzed for LA size, LVA percentage and distribution. The predictive value of demographic, anatomic, and mapping variables on AF recurrence was analyzed. RESULTS: 160 patients (50.6% male, 1.3 pre-ablations, 60% persistent AF) with complete LA voltage maps were included. Mean follow-up time was 16 ± 11 months. Mean recorded electrograms (EGMs) per map were 9754 ± 5808, mean LA volume was 176.1 ± 35.9 ml and mean rate of LVAs <0.5 mV was 30.6% ± 23.1%. During follow-up recurrence rate of AF or AT >30 s was 55.6%. Patients with recurrence had a significant higher percentage of LVAs (40.0% vs. 18.8%, p < .001) but no relevant difference in LA volume (172 vs. 178 mL, p = .299). ROC curves revealed LVA as a good predictor for recurrence (AUC = 0.79, p < .001) and a cut-off of 22% LVAs with highest sensitivity (73.0%) and specificity (71.8%). Based on this cut off, event free survival was significantly higher in the Low LVA group (p < .01). CONCLUSION: Total LVA percentage has a good predictive power on arrhythmia recurrence in a cohort of advanced scarred left atria in repeat procedures independent of the applied ablation strategy. Left atrial volume seems to have minor impact on the rhythm outcome in our study cohort.
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Potenciais de Ação , Fibrilação Atrial , Função do Átrio Esquerdo , Ablação por Cateter , Técnicas Eletrofisiológicas Cardíacas , Átrios do Coração , Frequência Cardíaca , Valor Preditivo dos Testes , Recidiva , Sistema de Registros , Humanos , Fibrilação Atrial/cirurgia , Fibrilação Atrial/fisiopatologia , Fibrilação Atrial/diagnóstico , Masculino , Feminino , Ablação por Cateter/efeitos adversos , Pessoa de Meia-Idade , Idoso , Átrios do Coração/fisiopatologia , Átrios do Coração/cirurgia , Fatores de Risco , Fatores de Tempo , Estudos Prospectivos , Reoperação , Medição de Risco , Resultado do Tratamento , Taquicardia Supraventricular/fisiopatologia , Taquicardia Supraventricular/cirurgia , Taquicardia Supraventricular/diagnóstico , Taquicardia Supraventricular/etiologia , Remodelamento AtrialRESUMO
Background: Gender-related aspects in cardiac arrhythmias have gained increasing attention, still the understanding of peripartum electrical disorders remains vague. Case summary: A 28-year-old woman developed palpitations and presyncopes during the post-partum period after her second pregnancy. Palpitations remained unclear until a self-recorded single-lead smartwatch ECG revealed a complete episode of a fast broad complex tachycardia (260â b.p.m.) that led to hospital admission. Echocardiography, cardiac magnetic resonance imaging, and exercise testing, showed no relevant abnormalities. Recording the tachycardia in a 12-lead-ECG could eventually be achieved revealing an inferior axis and positive concordance in the precordial leads. Episodes of ventricular tachycardia (VT) could be provoked by breast feeding and mental stress, but not induced in two electrophysiological studies. Genetic testing was normal. The patient continued to experience repeated, self-terminating VT episodes, lasting between 10 and 40â s, leading to presyncopes and a syncope with a fall. The beginning of symptoms subsequent to child birth and frequent premature ventricular contractions in her first pregnancy made hormone-induced arrhythmia a tentative diagnosis. Heart rate-corrected QT (QTc) intervals showed significant variability corresponding to the frequency of episodes in a retrospective evaluation. The cessation of breastfeeding led to a termination of arrhythmias. The patient was temporarily equipped with a wearable cardioverter defibrillator vest, an implantable cardioverter defibrillator (ICD) was not implanted. Discussion: The case report highlights the potential of self-recorded, patient-activated ECG monitoring in diagnosing recurrent palpitations, and the dilemma of timing for implanting ICDs in young patients with ventricular arrythmias (VTs). Additionally, it underlines the role of post-partum hormones in the susceptibility to ventricular arrhythmias, calling for further research of gender-specific, and pregnancy-associated arrhythmias.
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BACKGROUND: Mitral transcatheter edge-to-edge repair (M-TEER) is a guideline-recommended treatment option for patients with severe symptomatic mitral regurgitation (MR). Outcomes with the PASCAL system in a post-market setting have not been established. OBJECTIVES: The authors report 30-day and 1-year outcomes from the MiCLASP (Transcatheter Repair of Mitral Regurgitation with Edwards PASCAL Transcatheter Valve Repair System) European post-market clinical follow-up study. METHODS: Patients with symptomatic, clinically significant MR were prospectively enrolled. The primary safety endpoint was clinical events committee-adjudicated 30-day composite major adverse event rate and the primary effectiveness endpoint was echocardiographic core laboratory-assessed MR severity at discharge compared with baseline. Clinical, echocardiographic, functional, and quality-of-life outcomes were assessed at 1 year. RESULTS: A total of 544 patients were enrolled (59% functional MR, 30% degenerative MR). The 30-day composite major adverse event rate was 6.8%. MR reduction was significant from baseline to discharge and sustained at 1 year with 98% of patients achieving MR ≤2+ and 82.6% MR ≤1+ (all P < 0.001 vs baseline). One-year Kaplan-Meier estimate for survival was 87.3%, and freedom from heart failure hospitalization was 84.3%. Significant functional and quality-of-life improvements were observed at 1 year, including 71.6% in NYHA functional class I/II, 14.4-point increase in Kansas City Cardiomyopathy Questionnaire score, and 24.2-m improvement in 6-minute walk distance (all P < 0.001 vs baseline). CONCLUSIONS: One-year outcomes of this large cohort from the MiCLASP study demonstrate continued safety and effectiveness of M-TEER with the PASCAL system in a post-market setting. Results demonstrate high survival and freedom from heart failure hospitalization, significant and sustained MR reduction, and improvements in symptoms, functional capacity, and quality of life.
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Insuficiência Cardíaca , Implante de Prótese de Valva Cardíaca , Insuficiência da Valva Mitral , Humanos , Seguimentos , Valva Mitral/diagnóstico por imagem , Valva Mitral/cirurgia , Insuficiência da Valva Mitral/diagnóstico por imagem , Insuficiência da Valva Mitral/cirurgia , Qualidade de Vida , Resultado do Tratamento , Implante de Prótese de Valva Cardíaca/efeitos adversos , Cateterismo Cardíaco/efeitos adversosRESUMO
INTRODUCTION: Infections associated with cardiac implantable electronic devices (CIEDs) are a multifactorial disease that leads to increased morbidity and mortality. OBJECTIVE: The aim was to analyze patient-, disease- and treatment-related characteristics including microbiological and bacterial spectrum according to survival status and to identify risk factors for 1- and 3-year mortality in patients with local and systemic CIED infection. METHODS: In a retrospective cohort study, we analyzed data from patients with CIED-related local or systemic infection undergoing successful transvenous lead extraction (TLE). Survival status as well as incidence and cause of rehospitalization were recorded. Microbiology and antibiotics used as first-line therapy were compared according to mortality. Independent risk factors for 1- and 3-year mortality were determined. RESULTS: Data from 243 Patients were analyzed. In-hospital mortality was 2.5%. Mortality rates at 30 days, 1- and 3 years were 4.1%, 18.1% and 30%, respectively. Seventy-four (30.5%) patients had systemic bacterial infection. Independent risk factors for 1-year mortality included age (OR 1.05 [1.01-1.10], p = 0.014), NT-proBNP at admission (OR 4.18 [1.81-9.65], p = 0.001), new onset or worsened tricuspid regurgitation after TLE (OR 6.04 [1.58-23.02], p = 0.009), and systemic infection (OR 2.76 [1.08-7.03], p = 0.034), whereas systemic infection was no longer an independent risk factor for 3-year mortality. Staphylococcus aureus was found in 18.1% of patients who survived and in 25% of those who died, p = 0.092. There was a high proportion of methicillin-resistant strains among coagulase-negative staphylococci (16.5%) compared to Staphylococcus aureus (1.2%). CONCLUSIONS: Staphylococci are the most common causative germs of CIED-infection with coagulase-negative staphylococci showing higher resistance rates to antibiotics. The independent risk factors for increased long-term mortality could contribute to individual risk stratification and well-founded treatment decisions in clinical routine. Especially the role of tricuspid regurgitation as a complication after TLE should be investigated in future studies.
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Antibacterianos , Desfibriladores Implantáveis , Remoção de Dispositivo , Mortalidade Hospitalar , Marca-Passo Artificial , Infecções Relacionadas à Prótese , Humanos , Masculino , Feminino , Estudos Retrospectivos , Infecções Relacionadas à Prótese/microbiologia , Infecções Relacionadas à Prótese/mortalidade , Infecções Relacionadas à Prótese/diagnóstico , Infecções Relacionadas à Prótese/epidemiologia , Idoso , Desfibriladores Implantáveis/efeitos adversos , Fatores de Risco , Marca-Passo Artificial/efeitos adversos , Antibacterianos/uso terapêutico , Mortalidade Hospitalar/tendências , Pessoa de Meia-Idade , Incidência , Idoso de 80 Anos ou mais , Fatores de Tempo , Taxa de Sobrevida/tendênciasRESUMO
AIMS: Achieving optimized guideline-directed medical therapy (GDMT) is recommended prior to transcatheter mitral valve edge-to-edge repair (M-TEER) for secondary mitral regurgitation (SMR). We aimed to propose and validate an easy-to-use score for assessing the quality of GDMT in patients with heart failure with reduced ejection fraction (HFrEF) undergoing M-TEER. METHODS AND RESULTS: Among the 1641 EuroSMR patients enrolled in the EuroSMR Registry who underwent M-TEER, a total of 1072 patients [median age 74, interquartile range (IQR) 67-79 years, 29% female] had complete data on GDMT and a left ventricular ejection fraction ≤ 40% and were included in the current study. We proposed a GDMT score that considers the dosage levels of three medication classes (angiotensin-converting enzyme inhibitors/angiotensin receptor blockers/angiotensin receptor-neprilysin inhibitors, beta-blockers, and mineralocorticoid receptor antagonists), with a maximum score of 12 points indicating optimal GDMT. The primary outcome was all-cause mortality. The median GDMT score was 4 points (IQR 3-6). All three domains of the scoring system were associated with all-cause mortality (P < 0.05 for all). The overall GDMT score was associated with all-cause mortality (hazard ratio 0.90, 95% confidence interval 0.86-0.95 for each 1-point increase in the GDMT score). This association remained significant after adjusting for renal function and co-morbidities. CONCLUSIONS: This study demonstrates the utility of a simple GDMT scoring system for assessing the adequacy of GDMT in HFrEF patients with relevant SMR undergoing M-TEER. The GDMT score has potential applications in guiding the design of future clinical trials and aiding clinical decision-making processes.
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Insuficiência Cardíaca , Insuficiência da Valva Mitral , Valva Mitral , Volume Sistólico , Humanos , Feminino , Masculino , Insuficiência Cardíaca/fisiopatologia , Insuficiência Cardíaca/terapia , Idoso , Insuficiência da Valva Mitral/cirurgia , Insuficiência da Valva Mitral/fisiopatologia , Volume Sistólico/fisiologia , Valva Mitral/cirurgia , Sistema de Registros , Cateterismo Cardíaco/métodos , Função Ventricular Esquerda/fisiologia , Seguimentos , Guias de Prática Clínica como Assunto , Implante de Prótese de Valva Cardíaca/métodos , Resultado do TratamentoRESUMO
BACKGROUND: In the coming years, telemedicine will play a key role in health care. Especially in rural areas with weak infrastructure, telemedicine could be crucial to providing adequate and personalized medical care. OBJECTIVE: We investigated the acceptance and preferences of telemedicine among cardiologists, internists, and general practitioners. In addition, we aimed to identify knowledge, explore factors that influence the decision to adopt or reject this technology, and create starting points for demand-oriented further research. METHODS: We conducted a web-based survey between May 2021 and February 2022. The 34-item questionnaire covered a wide range of questions regarding knowledge, acceptance, and use of telemedicine in cardiology care. Participants (cardiologists, internists, and general practitioners) were contacted through their professional email addresses, through a QR code published in a regional health journal, and through X (formerly known as Twitter). After exclusion of questionnaires with missed values, multidimensional scaling and k-means clustering were performed. Participants were divided into 3 clusters (C1, C2, and C3) based on their attitudes toward telecardiology. C1 uses telemedicine for personal health and clinical practice; C2 shows reluctance; C3 uses telemedicine mainly clinically. RESULTS: We contacted 929 physicians. Of those 12.1% (112/929) completed the questionnaires. Participants were 56% male (54/97), 29% female (28/97), and 2% (2/97) diverse (median age 50 years). About 16% (18/112) of the respondents currently use telemedicine daily, 14.3% (16/112) 3-4 times a week, and 43% (48/112) did not use telemedicine at all. Overall, 35.1% (34/97) rated their knowledge of telemedicine as very good or good. Most of the respondents replied that telemedicine could support cardiology care in monitoring of blood pressure and electrocardiograms (57/97, 58.8%, both), consultation (57/97, 58.8%), and extending follow-up time (59/97, 60.8%). Reported barriers to implementation were mostly administration (26/97, 26.8%), inadequate reimbursement (25/97, 25.8%), and the purchase of technology equipment (23/97, 23.7%). Attitudes toward telemedicine in clinical practice were closely related to the number of patients being treated per annual quarter: C3 (median 1350, IQR 1000-1500) versus C1 (median 750, IQR 300-1200) and C2 (median 500, IQR 105-825). The differences between clinical caseloads of C1-C3 members were significant: C1 versus C2 (P=.03), C1 versus C3 (P=.02), and C2 versus C3 (P<.001). Most participants (87/112, 77.7%) would like to expand telemedicine approaches in the future. In the field of cardiology, the participants reported a high suitability of telemedicine. The willingness to train in telemedicine is high to very high for > 50% of the participants. CONCLUSIONS: Our results indicate generally moderate use but positive attitudes toward telemedicine among participating physicians with a higher clinical caseload. The lack of a structural framework seems to be a barrier to the effective implementation of telecardiology.
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Right heart failure is a major challenge in clinical practice. Soluble Suppression of Tumorigenicity-2 (sST2), a member of the interleukin-1-receptor family, may have clinical prognostic value. The aim of this study was to analyze whether sST2 correlates with signs of acute right heart decompensation. This prospective single-center study included 50 patients admitted for clinical signs of predominant right heart decompensation. Signs of reduced blood supply to other organs (e.g., renal function parameter, troponin T, NT-proBNP), diuretics, and signs of venous congestion (inferior vena cava (IVC) diameter) with fluid retention (weight gain, peripheral edema) resulting from reduced RV function were analyzed. The degree of peripheral edema was defined as none, mild (5-6 mm depressible, regression in 15-60 s) or severe (>7 mm depressible, regression in 2-3 min). sST2 levels were measured at the day of hospitalization. A total of 78.7% showed severe peripheral edema. The median concentration of sST2 was 35.2 ng/mL (25.-75. percentiles 17.2-46.7). sST2 is correlated with the peripheral edema degree (rSpearman = 0.427, p = 0.004) and the diameter of IVC (r = 0.786, p = 0.036), while NT-proBNP (r = 0.114, p = 0.456), troponin T (r = 0.123, p = 0.430), creatinine-based eGFR (r = -0.207, p = 0.195), or cystatin C-based eGFR (r = -0.032, p = 0.839) did not. sST2, but no other established marker, is correlated with peripheral and central fluid status in patients with decompensated right heart failure.
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INTRODUCTION: Although transfemoral aortic valve replacement (TAVR) is a safe treatment for elderly patients with severe aortic valve stenosis, postoperative microembolism has been described. In this secondary endpoint analysis of the POST-TAVR trial, we aimed to investigate whether changes in neuron-specific enolase (NSE)-a biomarker of neuronal damage-are associated with changes in memory function or postoperative delirium (POD). MATERIALS AND METHODS: This was a prospective single-center study enrolling patients undergoing elective TAVR. Serum NSE was measured before and 24 h after TAVR. POD was diagnosed using CAM-ICU testing. Memory function was assessed before TAVR and before hospital discharge using the "Consortium to Establish a Registry for Alzheimer's Disease" (CERAD) word list and the digit span task (DST) implemented in "∆elta-App". RESULTS: Subjects' median age was 82 years (25th to 75th percentile: 77.5-85.0), 42.6% of subjects were women. CERAD scores significantly increased from pre- to post-TAVR, with p < 0.001. POD occurred in 4.4% (6/135) of subjects at median 2 days after TAVR. After TAVR, NSE increased from a median of 1.85 ng/mL (1.30-2.53) to 2.37 ng/mL (1.69-3.07), p < 0.001. The median increase in NSE was 40.4% (13.1-138.0) in patients with POD versus 17.3% (3.3-43.4) in those without POD (p = 0.17). CONCLUSIONS: Memory function improved after TAVR, likely due to learning effects, with no association to change in NSE. Patients with POD appear to have significantly higher postoperative levels of NSE compared to patients without POD after TAVR. This finding suggests that neuronal damage, as indicated by NSE elevation, may not significantly impair assessed memory function after TAVR.
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BACKGROUND: Both highly specialized heart centres and less specialized hospitals care for patients with implantable ICDs/CRT-Ds with remote monitoring. OBJECTIVE: To investigate potential differences in patient treatment according to centre's ICD implantation volume. METHODS: Based on their 2012 ICD/CRT-D implantation volume, centres enrolled in the NORDIC ICD trial in Germany were assigned to one of three groups: high- (HV, n= 345), medium- (MV, n= 340) or low-volume (LV, n= 189). RESULTS: The HV-centres had a significant higher CRT-D proportion (41.7%; LV: 36.5%; MV: 23.2%; Pðððððð< 0.001), significant shorter median procedure duration (49 min; MV: 58 min; LV: 60 min; Pðððððð< 0.001) but significant longer median hospital stay (4 days; MV and LV: 3 days; Pðððððð< 0.001) compared to MV- and LV-centres. The X-ray exposure was shorter in MV/HV-centres (MV: 3.4 min; HV: 3.6 min; LV: 5.5 min; Pðððððð< 0.001). Only 3.5% (LV: 2.6%; HV: 3.5%; MV: 4.1%) patients received at least one delivered inappropriate shock and 2.5% (HV: 2.0%; LV: 2.6%; MV: 2.9%) patients had withheld inappropriate ICD shocks without subsequent inappropriate shock delivery within 24.5 months of median follow-up. CONCLUSION: Implantation volume-dependent differences were observed in the device selection, procedure duration and x-ray exposure duration. Remote monitoring in combination with adequate response pattern prevented imminent inappropriate shocks in all three groups.
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Detection and timely intervention of acute kidney injury (AKI) is a major challenge worldwide. Electronic alerts for AKI may improve process- and patient-related endpoints. The present study evaluated the efficacy of an AKI electronic alert system and care bundle. This is a two-arm, prospective, cluster-randomized, controlled trial enrolling patients with AKI (KDIGO criteria) and cardiac diseases. Patients were randomly assigned to a routine care group or intervention group (DRKS-IDDRKS00017751). Two hundred patients (age 79 years, 46% female) were enrolled, with 100 patients in each group. The primary endpoint did not differ between patients in the routine care group 0.5 (-7.6-10.8) mL/min/1.73 m2 versus patients in the intervention group 1.0 (-13.5-15.1) mL/min/1.73 m2, p = 0.527. Proportions of patients in both study groups with hyperkalemia, pulmonary edema, and renal acidosis were comparable. The stop of antihypertensive medication during hypotensive periods was more frequent in patients in the intervention group compared to patients in the control group, p = 0.029. The AKI diagnosis and text module for AKI in the discharge letter were more frequently documented in patients in the intervention group (40%/48% vs. 25%/34%, p = 0.034; p = 0.044, respectively). Continued intake of RAAS inhibitors and the presence of a cardiac device were independently associated with a less pronounced decrease in eGFR from admission to the lowest value. In this RCT, electronic alerts for AKI and a care bundle improved process- but not patient-related endpoints.
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BACKGROUND: Transfemoral aortic valve replacement (TAVR) is the standard treatment for elderly patients with aortic valve stenosis. Although safe and well-established, there is a risk of intraprocedural hemodynamic instability and silent cerebral embolism, which can lead to a decline in neurocognitive function and dementia. In clinical practice, comprehensive cognitive testing is difficult to perform. AI-assisted digital applications may help to optimize diagnosis and monitoring. METHODS: Neurocognitive function was assessed by validated psychometric tests using "∆elta -App", which uses artificial intelligence and computational linguistic methods for extraction and analysis. Memory function was assessed using the 'Consortium to Establish a Registry for Alzheimer's Disease' (CERAD) word list and digit span task (DST) before TAVR and before hospital discharge. The study is registered in the German Register of Clinical Trials (https://drks.de/search/de/trial/DRKS00020813). RESULTS: From October 2020 until March 2022, 141 patients were enrolled at University Hospital Heart Centre Brandenburg. Mean age was 81 ± 6 years, 42.6% were women. Time between the pre- and post-interventional test was on average 6 ± 3 days. Memory function before TAVR was found to be below average in relation to age and educational level. The pre-post TAVR comparison showed significant improvements in the wordlist repeat, P < 0.001 and wordlist recall test of CERAD, P < 0.001. There were no changes in the digital span test. CONCLUSIONS: Despite impaired preoperative memory function before TAVR, no global negative effect on memory function after TVAR was detected. The improvements shown in the word list test should be interpreted as usual learning effects in this task.
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Background: This study aimed to determine whether novel and conventional cardiorenal biomarkers in patients before transcatheter aortic valve implantation may be associated with cardiorenal syndrome (CRS) type 1. Methods: Serum NT-proBNP and urine biomarkers (hepcidin-25, NGAL, IL-6) were measured before and 24 h after transcatheter aortic valve implantation. Results: 16/95 patients had CRS type 1. Those patients had longer length of stay in hospital (12.5 [9.0-16.0] vs 9.0 [8-12] days; p = 0.025) and were more frequently readmitted to hospital within 6 months after discharge (46.7 vs 15.6%; odds ratio: 4.7; 95% CI: 1.5-15.5; p = 0.007). The NT-proBNP/urine hepcidin-25 ratio (odds ratio: 2.89; 95% CI: 1.30-6.41; p = 0.009) was an independent modifier of CRS type 1. Conclusion: The NT-proBNP/urine hepcidin-25 ratio appears to be a modifier of risk of CRS type 1.
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Estenose da Valva Aórtica , Síndrome Cardiorrenal , Humanos , Hepcidinas , Peptídeo Natriurético Encefálico , Estenose da Valva Aórtica/complicaçõesRESUMO
Background: The prevalence of young patients with cardiac implantable electronic devices (CIED) is steadily increasing, accompanied by a rise in the occurrence of complications related to CIEDs. Consequently, transvenous lead extraction (TLE) has become a crucial treatment approach for such individuals. Objective: The purpose of this study was to examine the characteristics and procedural outcomes of young patients who undergo TLE, with a specific focus on identifying independent risk factors associated with adverse events. Methods: All patients in the GALLERY (GermAn Laser Lead Extraction RegistrY) were categorized into two groups based on their age at the time of enrollment: 45 years or younger, and over 45 years. A subgroup analysis was conducted specifically for the younger population. In this analysis, predictor variables for all-cause mortality, procedural complications, and procedural failure were evaluated using multivariable analyses. Results: We identified 160 patients aged 45 years or younger with a mean age of 35.3 ± 7.6 years and 42.5% (n = 68) female patients. Leading extraction indication was lead dysfunction in 51.3% of cases, followed by local infections in 20.6% and systemic infections in 16.9%. The most common device to be extracted were implantable cardioverter-defibrillators (ICD) with 52.5%. Mean number of leads per patient was 2.2 ± 1.0. Median age of the oldest indwelling lead was 91.5 [54.75-137.5] months. Overall complication rate was 3.8% with 1.9% minor and 1.9% major complications. Complete procedural success was achieved in 90.6% of cases. Clinical procedural success rate was 98.1%. Procedure-related mortality was 0.0%. The all-cause in-hospital mortality rate was 2.5%, with septic shock identified as the primary cause of mortality. Multivariable analysis revealed CKD (OR: 19.0; 95% CI: 1.84-194.9; p = 0.018) and systemic infection (OR: 12.7; 95% CI: 1.14-142.8; p = 0.039) as independent predictor for all-cause mortality. Lead age ≥ 10 years (OR: 14.58, 95% CI: 1.36-156.2; p = 0.027) was identified as sole independent risk factor for procedural complication. Conclusion: TLE in young patients is safe and effective with a procedure-related mortality rate of 0.0%. CKD and systemic infection are predictors for all-cause mortality, whereas lead age ≥ 10 years was identified as independent risk factor for procedural complications in young patients undergoing TLE.
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AIMS: Remote monitoring (RM) of thoracic impedance represents an early marker of pulmonary congestion in heart failure (HF). Chronic kidney disease (CKD) may promote fluid overload in HF patients. We investigated whether concomitant CKD affected the efficacy of impedance-based RM in the OptiLink HF trial. METHODS AND RESULTS: Among HF patients included in the OptiLink HF trial, time to the first cardiovascular hospitalization and all-cause death according to the presence of concomitant CKD was analysed. CKD was defined as GFR < 60 mL/min/1.73 m2 at enrolment. Of the 1002 patients included in OptiLink HF, 326 patients (33%) had HF with concomitant CKD. The presence of CKD increased transmission of telemedical alerts (median of 2 (1-5) vs. 1 (0-3); P = 0.012). Appropriate contacting after alert transmission was equally low in patients with and without CKD (57% vs. 59%, P = 0.593). The risk of the primary endpoint was higher in patients with CKD compared with patients without CKD (hazard ratio (HR), 1.62 [95% confidence interval (CI), 1.16-2.28]; P = 0.005). Impedance-based RM independently reduced primary events in HF patients with preserved renal function, but not in those with CKD (HR 0.68 [95% CI, 0.52-0.89]; P = 0.006). CONCLUSIONS: The presence of CKD in HF patients led to a higher number of telemedical alert transmissions and increased the risk of the primary endpoint. Inappropriate handling of alert transmission was commonly observed in patients with chronic HF and CKD. Guidance of HF management by impedance-based RM significantly decreased primary event rates in patients without CKD, but not in patients with CKD.