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BACKGROUND: Pre-hospital heparin administration has been reported to improve prognosis in patients with out-of-hospital cardiac arrest (OHCA). This beneficial effect may be limited to the subgroup of ST-segment elevation myocardial infarction (STEMI) patients. METHODS: To assess the impact of pre-hospital heparin loading on TIMI (Thrombolysis in Myocardial Infarction) flow grade and mortality in STEMI patients with OHCA, we analyzed data from 2,566 consecutive patients from two hospitals participating in the prospective Feedback Intervention and Treatment Times in ST-segment Elevation Myocardial Infarction (FITT-STEMI) trial. RESULTS: In 394 participants with OHCA, 272 (69%) received heparin from the emergency medical service (EMS). Collapse witnessed by EMS (odds ratio (OR) = 3.53, 95%-confidence interval (CI) = 1.54-8.09; p = 0.003) and pre-hospital ECG recording (OR = 3.32, 95% CI = 1.06-10.35; p = 0.039) were identified as parameters significantly associated with pre-hospital heparin use. In univariate analysis, in-hospital mortality was lower in the group receiving heparin in the pre-hospital setting (26.8% vs. 42.6%, p = 0.002). However, in a regression model, pre-hospital heparin use was no longer a significant predictor of mortality (OR = 0.992; p = 0.981). Patency of the infarct artery prior to coronary revascularization, as measured by TIMI flow grade, was not associated with pre-hospital administration of heparin in OHCA patients (OR = 0.840; p = 0.724). CONCLUSIONS: In STEMI patients with OHCA, pre-hospital use of heparin is neither associated with improved early patency of the infarct artery nor with a better prognosis. Our results do not support the assumption of a positive effect of heparin administration in the pre-hospital treatment phase in STEMI patients with OHCA. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00794001.
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BACKGROUND: Cardiac fibrosis plays a major pathophysiological role in any form of chronic heart disease, and high levels are associated with poor outcome. Diffuse and focal cardiac fibrosis are different subtypes, which have different pathomechanisms and prognostic implications. The total fibrosis burden in endomyocardial biopsy tissue was recently proved to play an independent prognostic role in aortic stenosis patients after transcatheter aortic valve implantation (TAVI). AIMS: Here, for the first time, we aim to assess the specific impact of different fibrosis subtypes on sudden cardiac death (SCD) as a primary reason for cardiovascular mortality after TAVI. METHODS: The fibrosis pattern was assessed histologically in the left ventricular biopsies obtained during TAVI interventions in 161 patients, who received a structured follow-up thereafter. RESULTS: Receiver operating characteristic analyses, performed 6, 12, 24 and 48 months after TAVI, showed diffuse, but not focal, fibrosis as a significant predictor for SCD at all timepoints, with the highest area under the curve at the first time point and a decrease in its SCD predictivity over time. In both multivariate Cox proportional hazards and Fine-Gray competing risk models, including both fibrosis subtypes, as well as age, sex and ejection fraction, high diffuse fibrosis remained statistically significant. Accordingly, it represents an independent SCD predictor, most importantly for the occurrence of early events. CONCLUSIONS: The burden of diffuse cardiac fibrosis plays an important and independent prognostic role regarding SCD early after TAVI. Therefore, the histological evaluation of fibrosis topography has value as a prognostic tool for TAVI patients and may help to tailor individualised approaches to optimise their postinterventional management.
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Estenosis de la Válvula Aórtica , Muerte Súbita Cardíaca , Fibrosis , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Masculino , Femenino , Anciano , Muerte Súbita Cardíaca/etiología , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/complicaciones , Estenosis de la Válvula Aórtica/mortalidad , Anciano de 80 o más Años , Factores de Riesgo , Miocardio/patología , PronósticoRESUMEN
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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Insuficiencia Cardíaca , Implantación de Prótesis de Válvulas Cardíacas , Insuficiencia de la Válvula Mitral , Humanos , Estudios de Seguimiento , Válvula Mitral/diagnóstico por imagen , Válvula Mitral/cirugía , Insuficiencia de la Válvula Mitral/diagnóstico por imagen , Insuficiencia de la Válvula Mitral/cirugía , Calidad de Vida , Resultado del Tratamiento , Implantación de Prótesis de Válvulas Cardíacas/efectos adversos , Cateterismo Cardíaco/efectos adversosRESUMEN
BACKGROUND AND AIMS: There is significant potential to streamline the clinical pathway for patients undergoing transcatheter aortic valve implantation (TAVI). The purpose of this study was to evaluate the effect of implementing BENCHMARK best practices on the efficiency and safety of TAVI in 28 sites in 7 European countries. METHODS: This was a study of patients with severe symptomatic aortic stenosis (AS) undergoing TAVI with balloon-expandable valves before and after implementation of BENCHMARK best practices. Principal objectives were to reduce hospital length of stay (LoS) and duration of intensive care stay. Secondary objective was to document patient safety. RESULTS: Between January 2020 and March 2023, 897 patients were documented prior to and 1491 patients after the implementation of BENCHMARK practices. Patient characteristics were consistent with a known older TAVI population and only minor differences. Mean LoS was reduced from 7.7 ± 7.0 to 5.8 ± 5.6 days (median 6 vs. 4 days; P < .001). Duration of intensive care was reduced from 1.8 to 1.3 days (median 1.1 vs. 0.9 days; P < .001). Adoption of peri-procedure best practices led to increased use of local anaesthesia (96.1% vs. 84.3%; P < .001) and decreased procedure (median 47 vs. 60â min; P < .001) and intervention times (85 vs. 95â min; P < .001). Thirty-day patient safety did not appear to be compromised with no differences in all-cause mortality (0.6% in both groups combined), stroke/transient ischaemic attack (1.4%), life-threatening bleeding (1.3%), stage 2/3 acute kidney injury (0.7%), and valve-related readmission (1.2%). CONCLUSIONS: Broad implementation of BENCHMARK practices contributes to improving efficiency of TAVI pathway reducing LoS and costs without compromising patient safety.
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Estenosis de la Válvula Aórtica , Benchmarking , Tiempo de Internación , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Estenosis de la Válvula Aórtica/cirugía , Masculino , Femenino , Anciano de 80 o más Años , Tiempo de Internación/estadística & datos numéricos , Anciano , Vías Clínicas , Europa (Continente)/epidemiología , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/prevención & control , Seguridad del PacienteRESUMEN
BACKGROUND: Data assessing the long-term safety and efficacy of mavacamten treatment for symptomatic obstructive hypertrophic cardiomyopathy are needed. OBJECTIVES: The authors sought to evaluate interim results from the EXPLORER-Long Term Extension (LTE) cohort of MAVA-LTE (A Long-Term Safety Extension Study of Mavacamten in Adults Who Have Completed EXPLORER-HCM; NCT03723655). METHODS: After mavacamten or placebo withdrawal at the end of the parent EXPLORER-HCM (Clinical Study to Evaluate Mavacamten [MYK-461] in Adults With Symptomatic Obstructive Hypertrophic Cardiomyopathy; NCT03470545), patients could enroll in MAVA-LTE. Patients received mavacamten 5 mg once daily; adjustments were made based on site-read echocardiograms. RESULTS: Between April 9, 2019, and March 5, 2021, 231 of 244 eligible patients (94.7%) enrolled in MAVA-LTE (mean age: 60 years; 39% female). At data cutoff (August 31, 2021) 217 (93.9%) remained on treatment (median time in study: 62.3 weeks; range: 0.3-123.9 weeks). At 48 weeks, patients showed improvements in left ventricular outflow tract (LVOT) gradients (mean change ± SD from baseline: resting: -35.6 ± 32.6 mm Hg; Valsalva: -45.3 ± 35.9 mm Hg), N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels (median: -480 ng/L; Q1-Q3: -1,104 to -179 ng/L), and NYHA functional class (67.5% improved by ≥1 class). LVOT gradients and NT-proBNP reductions were sustained through 84 weeks in patients who reached this timepoint. Over 315 patient-years of exposure, 8 patients experienced an adverse event of cardiac failure, and 21 patients had an adverse event of atrial fibrillation, including 11 with no prior history of atrial fibrillation. Twelve patients (5.2%) developed transient reductions in site-read echocardiogram left ventricular ejection fraction of <50%, resulting in temporary treatment interruption; all recovered. Ten patients discontinued treatment due to treatment-emergent adverse events. CONCLUSIONS: Mavacamten treatment showed clinically important and durable improvements in LVOT gradients, NT-proBNP levels, and NYHA functional class, consistent with EXPLORER-HCM. Mavacamten treatment was well tolerated over a median 62-week follow-up.
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Fibrilación Atrial , Cardiomiopatía Hipertrófica , Insuficiencia Cardíaca , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Cardiomiopatía Hipertrófica/tratamiento farmacológico , Volumen Sistólico , Función Ventricular IzquierdaAsunto(s)
Estenosis de la Válvula Aórtica , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Medición de Riesgo/métodos , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico , Prótesis Valvulares Cardíacas/efectos adversos , Diseño de Prótesis , Válvula Aórtica/cirugía , Válvula Aórtica/diagnóstico por imagen , Masculino , Femenino , Anciano , Anciano de 80 o más Años , Aorta/lesiones , Aorta/diagnóstico por imagenRESUMEN
AIMS: Obesity is causally related to the development of heart failure with preserved ejection fraction (HFpEF) but complicates the diagnosis and treatment of this disorder. We aimed to determine the relationship between severity of obesity and clinical, echocardiographic and haemodynamic parameters in a large cohort of patients with documented HFpEF. METHODS AND RESULTS: The REDUCE LAP-HF II trial randomized 626 patients with ejection fraction ≥40% and exercise pulmonary capillary wedge pressure (PCWP) ≥25 mmHg to atrial shunt or sham procedure. We tested for associations between body mass index (BMI), clinical characteristics, cardiac structural and functional abnormalities, physical limitations, quality of life and outcomes with atrial shunt therapy. Overall, 60.9% of patients had BMI ≥30 kg/m2 . As the severity of obesity increased, symptoms (Kansas City Cardiomyopathy Questionnaire score) and 6-min walk distance worsened. More severe obesity was associated with lower natriuretic peptide levels despite more cardiac remodelling, higher cardiac filling pressures, and higher cardiac output. Lower cut points for E/e' were needed to identify elevated PCWP in more obese patients. Strain measurements in all four chambers were maintained as BMI increased. Pulmonary vascular resistance at rest and exercise decreased with higher BMI. Obesity was associated with more first and recurrent heart failure events. However, there was no significant interaction between obesity and treatment effects of the atrial shunt. CONCLUSIONS: Increasing severity of obesity was associated with greater cardiac remodelling, higher right and left ventricular filling pressures, higher cardiac output and increased subsequent heart failure events. Despite significant obesity, many HFpEF patients have preserved right heart and pulmonary vascular function and thus, may be appropriate candidates for atrial shunt therapy.
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Flavinas , Insuficiencia Cardíaca , Luciferasas , Humanos , Volumen Sistólico , Cateterismo Cardíaco , Remodelación Ventricular , Calidad de Vida , Atrios Cardíacos , Obesidad/complicaciones , Función Ventricular IzquierdaRESUMEN
BACKGROUND: Extremely large aortic valve anatomy is one of the remaining limitations leading to exclusion of patients for transcatheter aortic valve replacement (TAVR). AIMS: The newly approved Myval 32 mm device is designed for use in aortic annulus areas up to 840 mm2 . Here we want to share the initial worldwide experience with the device. METHODS AND RESULTS: Retrospective data were collected from 10 patients with aortic stenosis and very large annular anatomy (mean area 765.5 mm2 ), who underwent implantation with 32 mm Myval transcatheter heart valve at eight centers. Valve Academic Research Consortium-2 device success was achieved in all cases. Mild paravalvular leak was observed in three patients and two patients required new pacemaker implantation. One patient experienced retroperitoneal hemorrhage caused by the contralateral 6 F sheath and required surgical revision. No device-related complications, stroke, or death from any cause occurred within the 30-day follow-up period. In a studied cohort of 2219 consecutive TAVR-screened patients from a central European site, only 0.27% of patients showed larger anatomy than covered by the 32 mm Myval device by instructions for use without off-label use of overexpansion. This rate was significantly higher for the 34 mm Evolut Pro (1.8%) and 29 mm Sapien 3 (2.1%) devices. CONCLUSIONS: The Myval 32 mm prosthesis showed promising initial results in a cohort of patients who previously had to be excluded from TAVR. It is desirable that all future TAVR systems accommodate larger anatomy to allow optimal treatment of all patients.
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Estenosis de la Válvula Aórtica , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Estudios Retrospectivos , Resultado del Tratamiento , Diseño de Prótesis , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversosRESUMEN
BACKGROUND: Extracorporeal life support (ECLS) is increasingly used in the treatment of infarct-related cardiogenic shock despite a lack of evidence regarding its effect on mortality. METHODS: In this multicenter trial, patients with acute myocardial infarction complicated by cardiogenic shock for whom early revascularization was planned were randomly assigned to receive early ECLS plus usual medical treatment (ECLS group) or usual medical treatment alone (control group). The primary outcome was death from any cause at 30 days. Safety outcomes included bleeding, stroke, and peripheral vascular complications warranting interventional or surgical therapy. RESULTS: A total of 420 patients underwent randomization, and 417 patients were included in final analyses. At 30 days, death from any cause had occurred in 100 of 209 patients (47.8%) in the ECLS group and in 102 of 208 patients (49.0%) in the control group (relative risk, 0.98; 95% confidence interval [CI], 0.80 to 1.19; P = 0.81). The median duration of mechanical ventilation was 7 days (interquartile range, 4 to 12) in the ECLS group and 5 days (interquartile range, 3 to 9) in the control group (median difference, 1 day; 95% CI, 0 to 2). The safety outcome consisting of moderate or severe bleeding occurred in 23.4% of the patients in the ECLS group and in 9.6% of those in the control group (relative risk, 2.44; 95% CI, 1.50 to 3.95); peripheral vascular complications warranting intervention occurred in 11.0% and 3.8%, respectively (relative risk, 2.86; 95% CI, 1.31 to 6.25). CONCLUSIONS: In patients with acute myocardial infarction complicated by cardiogenic shock with planned early revascularization, the risk of death from any cause at the 30-day follow-up was not lower among the patients who received ECLS therapy than among those who received medical therapy alone. (Funded by the Else Kröner Fresenius Foundation and others; ECLS-SHOCK ClinicalTrials.gov number, NCT03637205.).
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Oxigenación por Membrana Extracorpórea , Infarto del Miocardio , Choque Cardiogénico , Humanos , Oxigenación por Membrana Extracorpórea/efectos adversos , Oxigenación por Membrana Extracorpórea/mortalidad , Infarto del Miocardio/complicaciones , Infarto del Miocardio/terapia , Estudios Retrospectivos , Riesgo , Choque Cardiogénico/etiología , Choque Cardiogénico/terapia , Resultado del Tratamiento , Revascularización MiocárdicaRESUMEN
Aims: Identification of high-risk patients and individualized decision support based on objective criteria for rapid discharge after transcatheter aortic valve implantation (TAVI) are key requirements in the context of contemporary TAVI treatment. This study aimed to predict 30-day mortality following TAVI based on machine learning (ML) using data from the German Aortic Valve Registry. Methods and results: Mortality risk was determined using a random forest ML model that was condensed in the newly developed TAVI Risk Machine (TRIM) scores, designed to represent clinically meaningful risk modelling before (TRIMpre) and in particular after (TRIMpost) TAVI. Algorithm was trained and cross-validated on data of 22 283 patients (729 died within 30 days post-TAVI) and generalisation was examined on data of 5864 patients (146 died). TRIMpost demonstrated significantly better performance than traditional scores [C-statistics value, 0.79; 95% confidence interval (CI)] [0.74; 0.83] compared to Society of Thoracic Surgeons (STS) with C-statistics value 0.69; 95%-CI [0.65; 0.74]). An abridged (aTRIMpost) score comprising 25 features (calculated using a web interface) exhibited significantly higher performance than traditional scores (C-statistics value, 0.74; 95%-CI [0.70; 0.78]). Validation on external data of 6693 patients (205 died within 30 days post-TAVI) of the Swiss TAVI Registry confirmed significantly better performance for the TRIMpost (C-statistics value 0.75, 95%-CI [0.72; 0.79]) compared to STS (C-statistics value 0.67, CI [0.63; 0.70]). Conclusion: TRIM scores demonstrate good performance for risk estimation before and after TAVI. Together with clinical judgement, they may support standardised and objective decision-making before and after TAVI.
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Despite their remarkable performance, deep neural networks remain unadopted in clinical practice, which is considered to be partially due to their lack of explainability. In this work, we apply explainable attribution methods to a pre-trained deep neural network for abnormality classification in 12-lead electrocardiography to open this "black box" and understand the relationship between model prediction and learned features. We classify data from two public databases (CPSC 2018, PTB-XL) and the attribution methods assign a "relevance score" to each sample of the classified signals. This allows analyzing what the network learned during training, for which we propose quantitative methods: average relevance scores over a) classes, b) leads, and c) average beats. The analyses of relevance scores for atrial fibrillation and left bundle branch block compared to healthy controls show that their mean values a) increase with higher classification probability and correspond to false classifications when around zero, and b) correspond to clinical recommendations regarding which lead to consider. Furthermore, c) visible P-waves and concordant T-waves result in clearly negative relevance scores in atrial fibrillation and left bundle branch block classification, respectively. Results are similar across both databases despite differences in study population and hardware. In summary, our analysis suggests that the DNN learned features similar to cardiology textbook knowledge.
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AIMS: There is evidence to suggest that the subtype of aortic stenosis (AS), the degree of myocardial fibrosis (MF), and level of aortic valve calcification (AVC) are associated with adverse cardiac outcome in AS. Because little is known about their respective contribution, we sought to investigate their relative importance and interplay as well as their association with adverse cardiac events following transcatheter aortic valve replacement (TAVR). METHODS AND RESULTS: One hundred consecutive patients with severe AS and indication for TAVR were prospectively enrolled between January 2017 and October 2018. Patients underwent transthoracic echocardiography, multidetector computed tomography, and left ventricular endomyocardial biopsies at the time of TAVR. The final study cohort consisted of 92 patients with a completed study protocol, 39 (42.4%) of whom showed a normal ejection fraction (EF) high-gradient (NEFHG) AS, 13 (14.1%) a low EF high-gradient (LEFHG) AS, 25 (27.2%) a low EF low-gradient (LEFLG) AS, and 15 (16.3%) a paradoxical low-flow, low-gradient (PLFLG) AS. The high-gradient phenotypes (NEFHG and LEFHG) showed the largest amount of AVC (807 ± 421 and 813 ± 281 mm3 , respectively) as compared with the low-gradient phenotypes (LEFLG and PLFLG; 503 ± 326 and 555 ± 594 mm3 , respectively, P < 0.05). Conversely, MF was most prevalent in low-output phenotypes (LEFLG > LEFHG > PLFLG > NEFHG, P < 0.05). This was paralleled by a greater cardiovascular (CV) mortality within 600 days after TAVR (LEFLG 28% > PLFLG 26.7% > LEFHG 15.4% > NEFHG 2.5%; P = 0.023). In patients with a high MF burden, a higher AVC was associated with a lower mortality following TAVR (P = 0.045, hazard ratio 0.261, 95% confidence interval 0.07-0.97). CONCLUSIONS: MF is associated with adverse CV outcome following TAVR, which is most prevalent in low EF situations. In the presence of large MF burden, patients with large AVC have better outcome following TAVR. Conversely, worse outcome in large MF and relatively little AVC may be explained by a relative prominence of an underlying cardiomyopathy. The better survival rates in large AVC patients following TAVR indicate TAVR induced relief of severe AS-associated pressure overload with subsequently improved outcome.
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Estenosis de la Válvula Aórtica , Cardiomiopatías , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Válvula Aórtica/cirugía , Resultado del Tratamiento , Estenosis de la Válvula Aórtica/diagnóstico , Estenosis de la Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/complicaciones , FibrosisRESUMEN
AIMS: The REDUCE-LAP II trial demonstrated adverse outcomes after interatrial shunt device (IASD) placement in heart failure with preserved ejection fraction (HFpEF) attributed to latent pulmonary vascular disease (PVD). We hypothesized that exercise stress cardiovascular magnetic resonance (CMR) imaging could provide non-invasive characterization of cardiac and pulmonary physiology for improved patient selection. METHODS AND RESULTS: The HFpEF-Stress trial prospectively enrolled 75 patients with exertional dyspnoea and diastolic dysfunction. Patients underwent rest and exercise stress right heart catheterization, echocardiography and CMR imaging. Pulmonary artery and capillary wedge pressures, cardiac index (CI) and pulmonary vascular resistance (PVR) were calculated. Latent PVD was defined as increased PVR ≥ 1.74 Wood units during exercise stress. CMR assessed long-axis strains (LAS) and filling volumes of all cardiac chambers. Right ventricular (RV) function was further quantified by stroke and peak flow volumes. Patients with latent PVD (n = 24) showed lower RV function (rest tricuspid annular plane systolic excursion, p = 0.010; stress RV LAS, p < 0.001) compared to patients without (n = 43). During exercise stress, RV stroke and peak flow volumes (p < 0.001) were reduced and led to impaired left atrial filling (p = 0.040) with a strong statistical trend to impaired ventricular (LV) filling (p = 0.098). This subsequently resulted in reduced LV-CI (p < 0.001) despite preserved LV systolic function (LV LAS p ≥ 0.255). The degree of RV dysfunction during exercise stress best predicted latent PVD (RV peak flow, area under the curve at rest 0.73 vs. stress 0.89, p = 0.004). CONCLUSIONS: Latent PVD is a feature of HFpEF and is associated with impaired RV functional reserve, global diastolic filling and LV-CI. This can be quantified by CMR and used to identify patients likely to benefit from IASD implantation.
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Insuficiencia Cardíaca , Accidente Cerebrovascular , Humanos , Insuficiencia Cardíaca/complicaciones , Ventrículos Cardíacos , Presión Esfenoidal Pulmonar , Volumen Sistólico/fisiología , Función Ventricular IzquierdaRESUMEN
Transcatheter aortic valve replacement (TAVR) has become the standard treatment for aortic stenosis in older patients. It increasingly relies on accurate pre-procedural planning using multidetector computed tomography (MDCT). Since little is known about the required competence levels for MDCT analyses, we comprehensively assessed MDCT TAVR planning reproducibility and accuracy with regard to valve selection in various healthcare workers. 20 randomly selected MDCT of TAVR patients were analyzed using dedicated software by healthcare professionals with varying backgrounds and experience (two structural interventionalists, one imaging specialist, one cardiac surgeon, one general physician, and one medical student). Following the analysis, the most appropriate Edwards SAPIEN 3™ and Medtronic CoreValve valve size was selected. Intra- and inter-observer variability were assessed. The first structural interventionalist was considered as reference standard for inter-observer comparison. Excellent intra- and inter-observer variability was found for the entire group in regard to the MDCT measurements. The best intra-observer agreement and reproducibility were found for the structural interventionalist, while the medical student had the lowest reproducibility. The highest inter-observer agreement was between both structural interventionalists, followed by the imaging specialist. As to valve size selection, the structural interventionalist showed the highest intra-observer reproducibility, independent of the brand of valve used. Compared to the reference structural interventionalist, the second structural interventionalist showed the highest inter-observer agreement for valve size selection [ICC 0.984, 95% CI 0.969-0.991] followed by the cardiac surgeon [ICC 0.947, 95%CI 0.900-0.972]. The lowest inter-observer agreement was found for the medical student [ICC 0.507, 95%CI 0.067-0.739]. While current state-of-the-art MDCT analysis software provides excellent reproducibility for anatomical measurements, the highest levels of confidence in terms of valve size selection were achieved by the performing interventional physicians. This was most likely attributable to observer experience.
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Estenosis de la Válvula Aórtica , Prótesis Valvulares Cardíacas , Reemplazo de la Válvula Aórtica Transcatéter , Humanos , Anciano , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/cirugía , Tomografía Computarizada Multidetector/métodos , Reproducibilidad de los Resultados , Diseño de Prótesis , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/cirugía , Variaciones Dependientes del Observador , Estudios Retrospectivos , Valor Predictivo de las PruebasRESUMEN
The incidence of aortic valve stenosis (AS), the most common reason for aortic valve replacement (AVR), increases with population ageing. While untreated AS is associated with high mortality, different hemodynamic subtypes range from normal left-ventricular function to severe heart failure. However, the molecular nature underlying four different AS subclasses, suggesting vastly different myocardial fates, is unknown. Here, we used direct proteomic analysis of small left-ventricular biopsies to identify unique protein expression profiles and subtype-specific AS mechanisms. Left-ventricular endomyocardial biopsies were harvested from patients during transcatheter AVR, and inclusion criteria were based on echocardiographic diagnosis of severe AS and guideline-defined AS-subtype classification: 1) normal ejection fraction (EF)/high-gradient; 2) low EF/high-gradient; 3) low EF/low-gradient; and 4) paradoxical low-flow/low-gradient AS. Samples from non-failing donor hearts served as control. We analyzed 25 individual left-ventricular biopsies by data-independent acquisition mass spectrometry (DIA-MS), and 26 biopsies by histomorphology and cardiomyocytes by STimulated Emission Depletion (STED) superresolution microscopy. Notably, DIA-MS reliably detected 2273 proteins throughout each individual left-ventricular biopsy, of which 160 proteins showed significant abundance changes between AS-subtype and non-failing samples including the cardiac ryanodine receptor (RyR2). Hierarchical clustering segregated unique proteotypes that identified three hemodynamic AS-subtypes. Additionally, distinct proteotypes were linked with AS-subtype specific differences in cardiomyocyte hypertrophy. Furthermore, superresolution microscopy of immunolabeled biopsy sections showed subcellular RyR2-cluster fragmentation and disruption of the functionally important association with transverse tubules, which occurred specifically in patients with systolic dysfunction and may hence contribute to depressed left-ventricular function in AS.
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Estenosis de la Válvula Aórtica , Trasplante de Corazón , Implantación de Prótesis de Válvulas Cardíacas , Humanos , Implantación de Prótesis de Válvulas Cardíacas/métodos , Volumen Sistólico , Microscopía , Proteómica , Canal Liberador de Calcio Receptor de Rianodina , Donantes de Tejidos , Válvula Aórtica , Función Ventricular Izquierda/fisiología , Biopsia , Resultado del TratamientoRESUMEN
BACKGROUND: Since cardiovascular magnetic resonance (CMR) imaging allows comprehensive quantification of both myocardial function and structure we aimed to assess myocardial remodeling processes in patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR). METHODS: CMR imaging was performed in 40 patients with severe AS before and 1 year after TAVR. Image analyses comprised assessments of myocardial volumes, CMR-feature-tracking based atrial and ventricular strain, myocardial T1 mapping, extracellular volume fraction-based calculation of left ventricular (LV) cellular and matrix volumes, as well as ischemic and non-ischemic late gadolinium enhancement analyses. Moreover, biomarkers including NT-proBNP as well as functional and clinical status were documented. RESULTS: Myocardial function improved 1 year after TAVR: LV ejection fraction (57.9 ± 16.9% to 65.4 ± 14.5%, p = 0.002); LV global longitudinal (- 21.4 ± 8.0% to -25.0 ± 6.4%, p < 0.001) and circumferential strain (- 36.9 ± 14.3% to - 42.6 ± 11.8%, p = 0.001); left atrial reservoir (13.3 ± 6.3% to 17.8 ± 6.7%, p = 0.001), conduit (5.5 ± 3.2% to 8.4 ± 4.6%, p = 0.001) and boosterpump strain (8.2 ± 4.6% to 9.9 ± 4.2%, p = 0.027). This was paralleled by regression of total myocardial volume (90.3 ± 21.0 ml/m2 to 73.5 ± 17.0 ml/m2, p < 0.001) including cellular (55.2 ± 13.2 ml/m2 to 45.3 ± 11.1 ml/m2, p < 0.001) and matrix volumes (20.7 ± 6.1 ml/m2 to 18.8 ± 5.3 ml/m2, p = 0.036). These changes were paralleled by recovery from heart failure (decrease of NYHA class: p < 0.001; declining NT-proBNP levels: 2456 ± 3002 ng/L to 988 ± 1222 ng/L, p = 0.001). CONCLUSION: CMR imaging enables comprehensive detection of myocardial remodeling in patients undergoing TAVR. Regression of LV matrix volume as a surrogate for reversible diffuse myocardial fibrosis is accompanied by increase of myocardial function and recovery from heart failure. Further data are required to define the value of these parameters as therapeutic targets for optimized management of TAVR patients. Trial registration DRKS, DRKS00024479. Registered 10 December 2021-Retrospectively registered, https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00024479.
Asunto(s)
Estenosis de la Válvula Aórtica , Insuficiencia Cardíaca , Reemplazo de la Válvula Aórtica Transcatéter , Válvula Aórtica/diagnóstico por imagen , Válvula Aórtica/patología , Válvula Aórtica/cirugía , Estenosis de la Válvula Aórtica/diagnóstico por imagen , Estenosis de la Válvula Aórtica/patología , Estenosis de la Válvula Aórtica/cirugía , Medios de Contraste , Gadolinio , Humanos , Espectroscopía de Resonancia Magnética , Valor Predictivo de las Pruebas , Estudios Prospectivos , Volumen Sistólico , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Resultado del Tratamiento , Función Ventricular Izquierda , Remodelación VentricularRESUMEN
Automatic electrocardiogram (ECG) analysis has been one of the very early use cases for computer assisted diagnosis (CAD). Most ECG devices provide some level of automatic ECG analysis. In the recent years, Deep Learning (DL) is increasingly used for this task, with the first models that claim to perform better than human physicians. In this manuscript, a pilot study is conducted to evaluate the added value of such a DL model to existing built-in analysis with respect to clinical relevance. 29 12-lead ECGs have been analyzed with a published DL model and results are compared to build-in analysis and clinical diagnosis. We could not reproduce the results of the test data exactly, presumably due to a different runtime environment. However, the errors were in the order of rounding errors and did not affect the final classification. The excellent performance in detection of left bundle branch block and atrial fibrillation that was reported in the publication could be reproduced. The DL method and the built-in method performed similarly good for the chosen cases regarding clinical relevance. While benefit of the DL method for research can be attested and usage in training can be envisioned, evaluation of added value in clinical practice would require a more comprehensive study with further and more complex cases.
Asunto(s)
Fibrilación Atrial , Aprendizaje Profundo , Diagnóstico por Computador , Electrocardiografía , Humanos , Proyectos PilotoRESUMEN
BACKGROUND: Severe tricuspid regurgitation (TR) has limited treatment options and is associated with high morbidity and mortality. AIMS: We evaluated the safety and effectiveness of the Cardioband tricuspid valve reconstruction system from the ongoing European single-arm, multicentre, prospective TriBAND post-market clinical follow-up study. METHODS: Eligible patients had chronic symptomatic functional TR despite diuretic therapy and were deemed candidates for transcatheter tricuspid repair by the local Heart Team. RESULTS: Sixty-one patients had ≥severe functional TR. At baseline, 85% of patients were in NYHA Class III-IV, 94% had ≥severe TR (core laboratory-assessed) with 6.8% EuroSCORE II and 53% LVEF. Device success was 96.7%. At discharge, 59% (p<0.001) of patients achieved ≤moderate TR and 78% had at least one grade TR reduction. At 30 days, all-cause mortality and composite MAE rates were 1.6% and 19.7%, respectively; septolateral annular diameter was reduced by 20%, where 69% of patients achieved ≤moderate TR and 85% of patients had at least one grade TR reduction (all p<0.001). Mid-RVEDD, RA volume, and IVC diameter decreased by 10% (p=0.005), 21% (p<0.001), and 11% (p=0.022), respectively; 74% were in NYHA Class I-II (p<0.001) with improvements in overall KCCQ score by 17 points (p<0.001). CONCLUSIONS: In the TriBAND study, the Cardioband tricuspid system demonstrated favourable outcomes at discharge and 30 days in a challenging patient population with symptomatic ≥severe functional TR. Results showed significant reductions in annular diameter and TR severity, accompanied by early evidence of right heart remodelling and improvements in functional status and quality of life.