Tailored electrocardiographic-based criteria for different pacing locations within the left bundle branch.

BACKGROUND: Electrocardiographic (ECG)-based criteria are used to confirm left bundle branch (LBB) pacing (LBBP), but current cutoff values have never been validated for different pacing locations. OBJECTIVE: The purpose of this study was to describe diagnostic performance of V6-R wave peak time (RWPT), V6-V1 interpeak interval, and aVL-RWPT for different pacing sites within the LBB and to determine 100% specific values for each criterion at each pacing location. METHODS: Consecutive patients with confirmed LBBP were selected. Population was divided into subgroups based on the site of pacing: left bundle trunk pacing (LBTP), left septal fascicular pacing (LSFP), left posterior fascicular pacing (LPFP), and left anterior fascicular pacing (LAFP). RESULTS: A total of 147 patients with unequivocal LBB capture were analyzed. Left fascicular pacing was more frequently achieved (82.8%) than LBTP (17.2%). Diagnostic performance of V6-RWPT, V6-V1 interpeak interval, and aVL-RWPT for discrimination of LBBP was good in all subgroups. V6-RWPT cutoff values with 100% specificity (SP) for LBBP discrimination were 75 ms in LBTP, 68 ms in LPFP, 81 ms in LAFP, and 79.5 ms in LSFP. V6-V1 interpeak interval cutoff values with 100% SP for LBBP discrimination were 35.5 ms in LBTP, 53.5 ms in LPFP, 41 ms in LAFP, and 46 ms in LSFP. In LAFP, aVL-RWPT cutoff value with 100% SP for LBBP discrimination was 68 ms, but was 74 ms in LBTP, 74.5 ms in LSFP, and 73.5 ms in LPFP. CONCLUSIONS: Tailored ECG-based criteria might be useful to confirm LBBP at different pacing locations within the LBB.

Impact of Advanced Age on the Incidence of Major Adverse Cardiovascular Events in Patients with Type 2 Diabetes Mellitus and Stable Coronary Artery Disease in a Real-World Setting in Spain.

Patients with type 2 diabetes mellitus (T2DM) and coronary artery disease (CAD) without myocardial infarction (MI) or stroke are at high risk for major cardiovascular events (MACEs). We aimed to provide real-world data on age-related clinical characteristics, treatment management, and incidence of major cardiovascular outcomes in T2DM-CAD patients in Spain from 2014 to 2018. We used EHRead® technology, which is based on natural language processing and machine learning, to extract unstructured clinical information from electronic health records (EHRs) from 12 hospitals. Of the 4072 included patients, 30.9% were younger than 65 years (66.3% male), 34.2% were aged 65-75 years (66.4% male), and 34.8% were older than 75 years (54.3% male). These older patients were more likely to have hypertension (OR 2.85), angina (OR 1.64), heart valve disease (OR 2.13), or peripheral vascular disease (OR 2.38) than those aged <65 years (p < 0.001 for all comparisons). In general, they were also more likely to receive pharmacological and interventional treatments. Moreover, these patients had a significantly higher risk of MACEs (HR 1.29; p = 0.003) and ischemic stroke (HR 2.39; p < 0.001). In summary, patients with T2DM-CAD in routine clinical practice tend to be older, have more comorbidities, are more heavily treated, and have a higher risk of developing MACE than is commonly assumed from clinical trial data.

Atrial mechanical contraction and ambulatory atrioventricular synchrony: Predictors from the OPTIVALL study.

INTRODUCTION: The role that preprocedural factors have on atrioventricular synchrony (AVS) provided by leadless pacemakers requires investigation. METHODS AND RESULTS: We aimed to assess the correlation between mitral inflow echocardiographic parameters and p-wave morphology with the accelerometer A4 signal amplitude. We also sought to identify clinical and echocardiographic predictors of optimal ambulatory AVS (≥85% of cardiac cycles). Forty-three patients undergoing Micra AV implant from June 2020 to March 2023 were prospectively enrolled. Baseline echocardiogram and 12-lead resting ECG were performed. Device follow-up was scheduled at 24 h, 1, 3, and 6 months and yearly after the implant. Ambulatory AVS was studied with a 24 h Holter monitor performed at 3 months follow-up in 35 patients who remained in VDD mode. A4 signal amplitude at 1 month correlated to peak A wave velocity (r = .376; p = .024) at echocardiogram, but no relationship was found with peak A' wave velocity, E/A, or E'/A' ratio. P-wave amplitude in lead I and aVF correlated to A4 signal amplitude at 1- and 3-months follow-up, respectively. Median AVS during 24 h of daily activities was 85.6 ± 7.6% and remained stable up to 100 bpm. Twenty-three out of 35 patients (65.7%) reached optimal ambulatory AVS. There was no association between mitral inflow echocardiographic parameters and optimal AVS. Diabetes (OR: 0.05, 95% CI: 0.01-0.47; p = .009) and chronic obstructive pulmonary disease (COPD) (OR: 0.06, 95% CI: 0.01-0.63; p = .019) strongly predicted ambulatory AVS <85%. CONCLUSIONS: Diabetes and COPD should be considered when selecting candidates for Micra AV. Measurements of pulsed wave Doppler mitral inflow do not systematically reflect the behavior of the A4 signal amplitude.

Redefining QRS transition to confirm left bundle branch capture during left bundle branch area pacing.

Background: QRS transition criteria during dynamic manoeuvers are the gold-standard for non-invasive confirmation of left bundle branch (LBB) capture, but they are seen in <50% of LBB area pacing (LBBAP) procedures. Objective: We hypothesized that transition from left ventricular septal pacing (LVSP) to LBB pacing (LBBP), when observed during lead penetration into the deep interventricular septum (IVS) with interrupted pacemapping, can suggest LBB capture. Methods: QRS transition during lead screwing-in was defined as shortening of paced V6-R wave peak time (RWPT) by ≥10 ms from LVSP to non-selective LBBP (ns-LBBP) obtained during mid to deep septal lead progression at the same target area, between two consecutive pacing manoeuvres. ECG-based criteria were used to compared LVSP and ns-LBBP morphologies obtained by interrupted pacemapping. Results: Sixty patients with demonstrated transition from LVSP to ns-LBBP during dynamic manoeuvers were compared to 44 patients with the same transition during lead screwing-in. Average shortening in paced V6-RWPT was similar among study groups (17.3 ± 6.8 ms vs. 18.8 ± 4.9 ms for transition during dynamic manoeuvres and lead screwing-in, respectively; p = 0.719). Paced V6-RWPT and aVL-RWPT, V6-V1 interpeak interval and the recently described LBBP score, were also similar for ns-LBBP morphologies in both groups. LVSP morphologies showed longer V6-RWPT and aVL-RWPT, shorter V6-V1 interpeak interval and lower LBBP score punctuation, without differences among the two QRS transition groups. V6-RWPT < 75 ms or V6-V1 interpeak interval > 44 ms criterion was more frequently achieved in ns-LBBP morphologies obtained during lead screwing-in compared to those obtained during dynamic manoeuvres (70.5% vs. 50%, respectively p = 0.036). Conclusions: During LBBAP procedure, QRS transition from LVSP to ns-LBBP can be observed as the lead penetrates deep into the IVS with interrupted pacemapping. Shortening of at least 10 ms in paced V6-RWPT may serve as marker of LBB capture.

Combination of current and new electrocardiographic-based criteria: a novel score for the discrimination of left bundle branch capture.

AIMS: Most of the criteria used to diagnose direct capture of the left bundle branch (LBB) have never been validated in an external sample. We hypothesized that lead aVL might add relevant information, and the combination of several electrocardiograph (ECG)-based criteria might discriminate better LBB capture from left ventricular septal (LVS) capture, than each criterion separately. METHODS AND RESULTS: Single-centre study involving all consecutive patients who received LBB area pacing. LBB capture was defined according to QRS morphology transition criteria during decremental pacing. Multivariate logistic regression analysis was performed to develop a predictive score for LBB capture. A total of 71 patients with confirmed LBB capture were analysed. The optimal cut-off values of R wave peak time (RWPT) in lead V6 (V6-RWPT) and V6-V1 interpeak interval for the discrimination of LBB capture were <83 ms and ≥33 ms, respectively. The RWPT in lead aVL (aVL-RWPT) showed a good discrimination power for the differential diagnosis of LBB capture and LVS capture. The optimal value for aVL-RWPT was 79 ms [sensitivity (SN) and specificity (SP) of 71.2% and 88.4%, respectively]. A new score, with a good diagnostic performance (area under the curve of 0.976), was constructed gathering the information from V6-RWPT, aVL-RWPT, and V6-V1 interpeak interval. The optimal score of 3 points showed a SN and SP of 89.2% and 100%, respectively for the differentiation of LBB capture. CONCLUSIONS: ECG-based criteria are useful to confirm the capture of the LBB. The combination of V6-RWPT, aVL-RWPT, and V6-V1 interpeak interval values demonstrated better diagnostic performance than isolated measurements.

Major Adverse Cardiovascular Events in Coronary Type 2 Diabetic Patients: Identification of Associated Factors Using Electronic Health Records and Natural Language Processing.

Patients with Type 2 diabetes mellitus (T2DM) and coronary artery disease (CAD) are at high risk of developing major adverse cardiovascular events (MACE). This is a multicenter, retrospective, and observational study performed in Spain aimed to characterize these patients in a real-world setting. Unstructured data from the Electronic Health Records were extracted by EHRead®, a technology based on Natural Language Processing and machine learning. The association between new MACE and the variables of interest were investigated by univariable and multivariable analyses. From a source population of 2,184,662 patients, we identified 4072 adults diagnosed with T2DM and CAD (62.2% male, mean age 70 ± 11). The main comorbidities observed included arterial hypertension, hyperlipidemia, and obesity, with metformin and statins being the treatments most frequently prescribed. MACE development was associated with multivessel (Hazard Ratio (HR) = 2.49) and single coronary vessel disease (HR = 1.71), transient ischemic attack (HR = 2.01), heart failure (HR = 1.32), insulin treatment (HR = 1.40), and percutaneous coronary intervention (PCI) (HR = 2.27), whilst statins (HR = 0.73) were associated with a lower risk of MACE occurrence. In conclusion, we found six risk factors associated with the development of MACE which were related with cardiovascular diseases and T2DM severity, and treatment with statins was identified as a protective factor for new MACE in this study.

Optimizing atrial sensing parameters in leadless pacemakers: Atrioventricular synchrony achievement in the real world.

BACKGROUND: Performance of the leadless pacemaker capable of atrioventricular (AV) synchronous pacing in de novo patients warrants further investigation. OBJECTIVE: The aims of this study were to assess what programming changes are needed to achieve proper atrial tracking and to study the percentage of AV synchrony (AVS) the device can provide under real-world conditions. METHODS: Consecutive patients undergoing Micra AV implantation between June 2020 and November 2021 were studied. Reprogramming of atrial sensing parameters during follow-up was performed by following device counters. AVS was studied with an ambulatory 24-hour Holter monitor and automatically analyzed by an electrocardiogram delineation system. The primary end point was AVS ≥85% of total cardiac cycles during 24-hour Holter electrocardiogram monitoring. RESULTS: Thirty-one patients who remained in VDD mode were studied, and all of them required manual reprogramming. The automatic A3 window end was deactivated, and a fixed and short value was set in all patients throughout follow-up. AVS significantly increased from 68.7% ± 14.7% at 24-hour follow-up to 83.9% ± 7.4% at 1-month visit (P = .001). At 1-month visit, shorter A3 window end time (P = .019), higher A4 threshold (P = .011), and deactivation of the automatic A3 window (P = .054) were independently related to higher AVS. A total of 2,291,953 Holter-recorded cardiac cycles were analyzed. Median AVS during 24-hour daily activities was 87.6% (interquartile range 84.5%-90.6%). Twenty of 26 patients (79.6%) reached AVS ≥85% of cardiac cycles. CONCLUSION: High rates of AVS can be achieved in real-world patients undergoing leadless pacing. Manual reprogramming of the atrial sensing parameters is essential to optimize mechanically sensed atrial tracking.

Assessment of medical management in Coronary Type 2 Diabetic patients with previous percutaneous coronary intervention in Spain: A retrospective analysis of electronic health records using Natural Language Processing.

INTRODUCTION AND OBJECTIVES: Patients with type 2 diabetes (T2D) and stable coronary artery disease (CAD) previously revascularized with percutaneous coronary intervention (PCI) are at high risk of recurrent ischemic events. We aimed to provide real-world insights into the clinical characteristics and management of this clinical population, excluding patients with a history of myocardial infarction (MI) or stroke, using Natural Language Processing (NLP) technology. METHODS: This is a multicenter, retrospective study based on the secondary use of 2014-2018 real-world data captured in the Electronic Health Records (EHRs) of 1,579 patients (0.72% of the T2D population analyzed; n = 217,632 patients) from 12 representative hospitals in Spain. To access the unstructured clinical information in EHRs, we used the EHRead® technology, based on NLP and machine learning. Major adverse cardiovascular events (MACE) were considered: MI, ischemic stroke, urgent coronary revascularization, and hospitalization due to unstable angina. The association between MACE rates and the variables included in this study was evaluated following univariate and multivariate approaches. RESULTS: Most patients were male (72.13%), with a mean age of 70.5±10 years. Regarding T2D, most patients were non-insulin-dependent T2D (61.75%) with high prevalence of comorbidities. The median (Q1-Q3) duration of follow-up was 1.2 (0.3-4.5) years. Overall, 35.66% of patients suffered from at least one MACE during follow up. Using a Cox Proportional Hazards regression model analysis, several independent factors were associated with MACE during follow up: CAD duration (p < 0.001), COPD/Asthma (p = 0.021), heart valve disease (p = 0.031), multivessel disease (p = 0.005), insulin treatment (p < 0.001), statins treatment (p < 0.001), and clopidogrel treatment (p = 0.039). CONCLUSIONS: Our results showed high rates of MACE in a large real-world series of PCI-revascularized patients with T2D and CAD with no history of MI or stroke. These data represent a potential opportunity to improve the clinical management of these patients.

Infección por SARS-CoV-2: un factor predisponente para síndrome coronario agudo / SARS-CoV-2 infection: A predisposing factor for acute coronary syndrome

Introducción: Se han reportado series de casos de SCA en pacientes COVID 19. Nuestro objetivo fue describir su incidencia, características, y pronóstico a 3 meses. Para contextualizar esta incidencia se comparó con la incidencia de SCA intrahospitalarios durante el mismo periodo del 2019.MétodosEstudio observacional de cohortes multicéntrico, de 3.108 pacientes COVID-19 ingresados en dos hospitales madrileños, entre el 1 de marzo y 15 de mayo de 2020. Diez pacientes sufrieron un SCA durante la fase hospitalaria realizándose un seguimiento clínico de 3 meses. Se estudiaron asimismo los pacientes con SCA intrahospitalarios durante el mismo periodo del 2019.ResultadosLa incidencia de SCA en COVID-19 fue 3,31‰, significativamente superior a la del periodo 2019, de 1,01‰ (p=0,013). Los pacientes COVID-19 con SCA, tenían una infección grave, mayoritariamente SCACEST (80%) y enfermedad multivaso (67%). La tasa de mortalidad (30%) y reingresos hospitalarios a 3 meses (20%) fueron muy elevadas.ConclusionesEl SCA es una complicación más frecuente de lo habitual en COVID-19 grave pero poco común y con mal pronóstico inmediato y a 3 meses. (AU)

Introduction: Several case series of ACS have been reported in COVID 19 patients. We aim to study its incidence, characteristics, and three-month prognosis. To put this incidence in perspective we compared it with the incidence of in-hospital ACS during the same period of 2019.MethodsObservational multicenter cohort study of 3,108 COVID-19 patients admitted to two hospitals in Madrid between March 1st and May 15th, 2020. Ten patients suffered an ACS while being hospitalized for COVID 19 and were followed for three months. The ACS incidence in hospitalized patients during the same period of 2019 was also studied.ResultsThe incidence of ACS in COVID-19 patients was 3.31 ‰, significantly higher than in the 2019 period, 1.01 ‰ (p = 0.013). COVID-19 patients that suffered and ACS frequently had a severe infection, presented with STEMI (80%), and had multivessel disease (67%). Mortality rate (30%) and hospital readmissions at three months (20%) were very high.ConclusionsSevere COVID-19 patients develop ACS more frequently than expected. Although the overall incidence was low, it carried a poor immediate and three-month prognosis. (AU)

SARS-CoV-2 infection: A predisposing factor for acute coronary syndrome.

INTRODUCTION: Several case series of ACS have been reported in COVID 19 patients. We aim to study its incidence, characteristics, and three-month prognosis. To put this incidence in perspective we compared it with the incidence of in-hospital ACS during the same period of 2019. METHODS: Observational multicenter cohort study of 3.108 COVID-19 patients admitted to two hospitals in Madrid between March 1st and May 15th, 2020. Ten patients suffered an ACS while being hospitalized for COVID 19 and were followed for three months. The ACS incidence in hospitalized patients during the same period of 2019 was also studied. RESULTS: The incidence of ACS in COVID-19 patients was 3.31‰, significantly higher than in the 2019 period, 1.01‰ (p = 0.013). COVID-19 patients that suffered and ACS frequently had a severe infection, presented with STEMI (80%), and had multivessel disease (67%). Mortality rate (30%) and hospital readmissions at three months (20%) were very high. CONCLUSIONS: Severe COVID-19 patients develop ACS more frequently than expected. Although the overall incidence was low, it carried a poor immediate and three-month prognosis.

INTRODUCCIÓN: Se han reportado series de casos de SCA en pacientes COVID Nuestro objetivo fue describir su incidencia, características, y pronóstico a 3 meses. Para contextualizar esta incidencia se comparó con la incidencia de SCA intrahospitalarios durante el mismo periodo del 2019. MÉTODOS: Estudio observacional de cohortes multicéntrico, de 3.108 pacientes COVID-19 ingresados en dos hospitales madrileños, entre el 1 de marzo y 15 de mayo de 2020. Diez pacientes sufrieron un SCA durante la fase hospitalaria realizándose un seguimiento clínico de 3 meses. Se estudiaron asimismo los pacientes con SCA intrahospitalarios durante el mismo periodo del 2019. RESULTADOS: La incidencia de SCA en COVID-19 fue 3,31‰, significativamente superior a la del periodo 2019, de 1,01‰ (p = 0,013). Los pacientes COVID-19 con SCA, tenían una infección grave, mayoritariamente SCACEST (80%) y enfermedad multivaso (67%). La tasa de mortalidad (30%) y reingresos hospitalarios a 3 meses (20%) fueron muy elevadas. CONCLUSIONES: El SCA es una complicación más frecuente de lo habitual en COVID-19 grave pero poco común y con mal pronóstico inmediato y a 3 meses.

[SARS-CoV-2 infection: A predisposing factor for acute coronary syndrome]. / Infección por SARS-CoV-2: un factor predisponente para síndrome coronario agudo.

INTRODUCTION: Several case series of ACS have been reported in COVID 19 patients. We aim to study its incidence, characteristics, and three-month prognosis. To put this incidence in perspective we compared it with the incidence of in-hospital ACS during the same period of 2019. METHODS: Observational multicenter cohort study of 3,108 COVID-19 patients admitted to two hospitals in Madrid between March 1st and May 15th, 2020. Ten patients suffered an ACS while being hospitalized for COVID 19 and were followed for three months. The ACS incidence in hospitalized patients during the same period of 2019 was also studied. RESULTS: The incidence of ACS in COVID-19 patients was 3.31 ‰, significantly higher than in the 2019 period, 1.01 ‰ (p = 0.013). COVID-19 patients that suffered and ACS frequently had a severe infection, presented with STEMI (80%), and had multivessel disease (67%). Mortality rate (30%) and hospital readmissions at three months (20%) were very high. CONCLUSIONS: Severe COVID-19 patients develop ACS more frequently than expected. Although the overall incidence was low, it carried a poor immediate and three-month prognosis.

Persistent Pulmonary Hypertension in Corrected Valvular Heart Disease: Hemodynamic Insights and Long-Term Survival.

Background The determinants and consequences of pulmonary hypertension after successfully corrected valvular heart disease remain poorly understood. We aim to clarify the hemodynamic bases and risk factors for mortality in patients with this condition. Methods and Results We analyzed long-term follow-up data of 222 patients with pulmonary hypertension and valvular heart disease successfully corrected at least 1 year before enrollment who had undergone comprehensive hemodynamic and imaging characterization as per the SIOVAC (Sildenafil for Improving Outcomes After Valvular Correction) clinical trial. Median (interquartile range) mean pulmonary pressure was 37 mm Hg (32-44 mm Hg) and pulmonary artery wedge pressure was 23 mm Hg (18-26 mm Hg). Most patients were classified either as having combined precapillary and postcapillary or isolated postcapillary pulmonary hypertension. After a median follow-up of 4.5 years, 91 deaths accounted for 4.21 higher-than-expected mortality in the age-matched population. Risk factors for mortality were male sex, older age, diabetes mellitus, World Health Organization functional class III and higher pulmonary vascular resistance-either measured by catheterization or approximated from ultrasound data. Higher pulmonary vascular resistance was related to diabetes mellitus and smaller residual aortic and mitral valve areas. In turn, the latter correlated with prosthetic nominal size. Six-month changes in the composite clinical score and in the 6-minute walk test distance were related to survival. Conclusions Persistent valvular heart disease-pulmonary hypertension is an ominous disease that is almost universally associated with elevated pulmonary artery wedge pressure. Pulmonary vascular resistance is a major determinant of mortality in this condition and is related to diabetes mellitus and the residual effective area of the corrected valve. These findings have important implications for individualizing valve correction procedures. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT00862043.

Patient satisfaction with remote monitoring of cardiac implantable electronic devices: the VALIOSA questionnaire.

BACKGROUND: Remote monitoring of cardiac implantable electronic devices (CIEDs) has demonstrated substantial benefits. Treatment guidelines have therefore endorsed its use and is being increasingly adopted in the clinical setting, but the level of satisfaction they convey remains still unknown. We developed and validated a questionnaire to measure patient satisfaction with remote monitoring using Medtronic CareLink® Network and assessed its internal reliability and dimensional validity. METHODS: After a thorough literature review, cognitive debriefing of 18 patients, and an expert panel discussion, a 30-item instrument was proposed and grouped into 5 dimensions (items): 1- Information on cardiac condition (3), 2- Device convenience (3), 3- Transmission process (6), 4- Satisfaction with medical monitoring (8), and 5- General opinions (10). Correlation with the visual analog scale (VAS), overall health related quality of life (HRQoL) measured by the EuroQoL-5D accompanied by the VAS as well as with the Medical Outcomes Study (MOS) SF-36 were assessed. Psychometric properties, exploratory factor analysis and a second order confirmatory factor analysis (a hierarchical CFA with a general common factor explaining the relations between the first order common factors, See Figure 1) were estimated. Models were assessed based on item loading size, sign and statistical significance, and goodness-of-fit statistics. RESULTS: A total of 186 patients (77% male) with a mean age of 66.03 (SD = 13.94) years were assessed. 48% had implantable cardioverter-defibrillators, 24% had pacemakers, and 29% had cardiac resynchronization therapy devices. An overall Cronbach's α = 0.893 was achieved, with acceptable reliabilities for isolated dimensions. Correlations with corresponding VAS scales were meaningful and significant (p < 0.01). The second order factor solution yielded good goodness-of-fit indexes (χ2/df = 1.44, CFI = 0.96, TLI = 0.95, RMSEA = 0.05). Satisfaction with remote monitoring was not related to HRQoL (r < 0.05), except for the correlation between the SF-36 mental component and the information on cardiac condition dimension (r = 0.263, p < 0.001). CONCLUSIONS: The 30-item questionnaire showed good reliability and validity to assess satisfaction with remote monitoring in patients with CIEDs.

Prognostic role of NYHA class in heart failure patients undergoing primary prevention ICD therapy.

AIMS: Concerns about the prognostic value of NYHA functional class (FC) in heart failure (HF) patients carrying a prophylactic implantable cardioverter defibrillator (ICD) are still present. We aimed to compare whether mortality and arrhythmic risk were different, in a cohort of HF patients undergoing ICD-only implant, according to their FC. METHODS AND RESULTS: HF patients with left ventricle ejection fraction (LVEF) ≤35%, undergoing first prophylactic ICD-only implant were collected from a multicentre nationwide registry (2006-2015). Six hundred and twenty-one patients were identified (101 patients in NYHA I; 411 in NYHA II; 109 in NYHA III). After a mean follow-up of 4.4 years (±2.1), 126 patients died (20.3%). All-cause mortality risk was higher in symptomatic patients: 13.9% in NYHA I patients, 18.3% in NYHA II patients (HR: 1.8, 95% CI 1.1-3.2), and 32.9% in NYHA III patients (HR: 3.9, 95% CI 2.1-7.3). Seventy-eight out of all deaths were due to cardiovascular causes (12.6%). Cardiovascular mortality risk was also higher in symptomatic patients: 6.9% in NYHA I patients, 11% in NYHA II patients (HR: 2.2, 95% CI 1.1-4.9), and 23.9% in NYHA III (HR: 5.5, 95% CI 2.4-12.7). One hundred and seventeen patients received a first appropriate ICD therapy (19.4%). Arrhythmia free survival did not differ among study groups [20.8% in NYHA I patients, 18.7% in NYHA II (HR: 1.1, 95% CI 0.6-1.7) and 20.8% in NYHA III patients (HR: 1.3, 95% CI 0.7-2.5)]. NYHA class independently predicted cardiovascular mortality (NYHA III vs. NYHA I: HR, 4.7; 95% CI, 1.7-12.8, P = 0.002; NYHA II vs. NYHA I: HR, 2.1, 95% CI, 1.0-5.6, P = 0.05) but not all-cause death (NYHA III vs. NYHA I: HR: 1.8, 95% CI 0.8-3.9, P = 0.11; NYHA II vs. NYHA I: HR, 1.1, 95% CI 0.6-2.2, P = 0.71;). Atrial fibrillation, chronic kidney disease, and diabetes emerged as predictors of both all-cause death [(HR: 1.8, 95% CI 1.2-2.8, P = 0.005), (HR: 2.2, 95% CI 1.4-3.4, P < 0.001), (HR: 2.0, 95% CI 1.3-3.1, P = 0.001), respectively] and cardiovascular mortality [(HR: 1.8, 95% CI 1.1-3.1, P = 0.02), (HR: 3.1, 95% CI 1.8-5.4, P < 0.001), (HR: 1.7, 95% CI 1.1-3, P = 0.032), respectively]. CONCLUSIONS: Mortality in HF patients undergoing prophylactic ICD implantation was higher in symptomatic patients. NYHA functional class along with other comorbidities might be helpful to identify a subgroup of ICD carriers with poorer prognosis and higher risk of cardiovascular death.

Survival and arrhythmic risk among ischemic and non-ischemic heart failure patients with prophylactic implantable cardioverter defibrillator only therapy: A propensity score-matched analysis.

BACKGROUND: Concerns about the efficacy of prophylactic ICD in non-ischemic cardiomyopathy (NICM) heart failure (HF) patients are still present. We aimed to assess whether survival and arrhythmic risk were different among ischemic cardiomyopathy (ICM) and NICM ICD-only patients, along with specific predictors for mortality. METHODS: HF patients undergoing ICD-only implant were extracted from the nationwide multicenter UMBRELLA registry. Arrhythmic events were collected by remote monitoring and reviewed by a committee of experts. RESULTS: 782 patients (556 ICM; 226 NICM) were recruited: mean ejection fraction of 26.6%; 83.4% in NYHA class II-III; mean QRS duration of 108.9 ms (only 14.9% with QRS > 130 ms). After 4.35 years of mean follow-up, all-cause mortality rate was 4.2%/year. In propensity-score (PS) analysis no survival differences between ICM and NICM subgroups appeared (mortality rates: 19.4% vs. 20%, p = 0.375). Age (hazard ratio [HR] = 1.02, p = 0.009), diabetes (HR = 2.61, p ≤ 0.001), chronic obstructive pulmonary disease (HR = 2.13, p = 0.002), and previous HF (HR = 2.28, p = 0.027) correlated with increased mortality for the entire population, however atrial fibrillation (AF) (HR = 2.68, p = 0.002) and chronic kidney disease (HR = 3.74, p ≤ 0.001) emerged as specific predictors in NICM patients. At follow-up, 134 patients (17.1%) were delivered a first appropriate ICD therapy (5.1%/year) without significant differences between ICM and NICM patients in the PS analysis (17.6% vs. 15.8%, p = 0.968). ICD shocks were associated with a higher mortality (HR = 2.88, p < 0.001) but longer detection windows (HR = 0.57, p = 0.042) correlated with fewer appropriate therapies. CONCLUSIONS: Mortality and arrhythmia free survival is similar among ICM and NICM HF patients undergoing ICD-only implant for primary prevention strategy.

Single-brand dual-chamber discriminators to prevent inappropriate shocks in patients implanted with prophylactic implantable cardioverter defibrillators: a propensity-weighted comparison of single- and dual-chamber devices.

PURPOSE: Comparisons of the efficacy of dual- vs. single-chamber implantable cardioverter defibrillators (ICDs) in preventing inappropriate shocks have had contradictory results. We investigated whether dual-chamber devices have a lower risk of inappropriate shocks and the specific role of supraventricular tachycardia (SVT) discriminators. METHODS: All heart failure (HF) patients without an indication for pacing and implanted with a prophylactic ICD were recruited from the nationwide multicenter UMBRELLA registry. Arrhythmic events were collected by remote monitoring and reviewed by a committee of experts. RESULTS: Among 782 patients, single-chamber ICDs were implanted in 537 (68.7%) and dual-chamber devices in 245 (31.3%). During a mean follow-up of 52.2 ± 24.5 months, 109 inappropriate shocks were delivered in 49 patients (6.2%). In the propensity-score-matched analysis, dual-chamber ICDs were related to lower rates of inappropriate shocks as compared to single-chamber devices (0.9% vs. 11.8%, p = < 0.001, log-rank test). In multivariable Cox proportional analysis, independent predictors of inappropriate shock were history of atrial fibrillation (hazard ratio (HR) = 2.78, CI 1.37-5.64, p = 0.004), chronic kidney disease (HR = 6.15, CI 2.82-13.53, p < 0.001), and non-ischemic cardiomyopathy (HR = 2.84, CI 1.54-5.23, p = 0.001). Among ICD settings, PR logic was the only discriminator independently related to a reduced risk of inappropriate shocks (HR = 0.18, CI 0.06-0.48, p = 0.001), along with an SVT limit enabled over 200 bpm (HR = 0.24, CI 0.11-0.51, p < 0.001). CONCLUSIONS: In this nationwide cohort of primary prevention ICD-only patients, dual-chamber devices were related to lower risk of inappropriate shocks compared to single-chamber ICDs. Besides, PR logic and SVT limit > 200 bpm emerged as protective factors.

Sildenafil for improving outcomes in patients with corrected valvular heart disease and persistent pulmonary hypertension: a multicenter, double-blind, randomized clinical trial.

Aims: We aimed to determine whether treatment with sildenafil improves outcomes of patients with persistent pulmonary hypertension (PH) after correction of valvular heart disease (VHD). Methods and results: The sildenafil for improving outcomes after valvular correction (SIOVAC) study was a multricentric, randomized, parallel, and placebo-controlled trial that enrolled stable adults with mean pulmonary artery pressure ≥ 30 mmHg who had undergone a successful valve replacement or repair procedure at least 1 year before inclusion. We assigned 200 patients to receive sildenafil (40 mg three times daily, n = 104) or placebo (n = 96) for 6 months. The primary endpoint was the composite clinical score combining death, hospital admission for heart failure (HF), change in functional class, and patient global self-assessment. Only 27 patients receiving sildenafil improved their composite clinical score, as compared with 44 patients receiving placebo; in contrast 33 patients in the sildenafil group worsened their composite score, as compared with 14 in the placebo group [odds ratio 0.39; 95% confidence interval (CI) 0.22-0.67; P < 0.001]. The Kaplan-Meier estimates for survival without admission due to HF were 0.76 and 0.86 in the sildenafil and placebo groups, respectively (hazard ratio 2.0, 95% CI = 1.0-4.0; log-rank P = 0.044). Changes in 6-min walk test distance, natriuretic peptides, and Doppler-derived systolic pulmonary pressure were similar in both groups. Conclusion: Treatment with sildenafil in patients with persistent PH after successfully corrected VHD is associated to worse clinical outcomes than placebo. Off-label usage of sildenafil for treating this source of left heart disease PH should be avoided. The trial is registered with ClinicalTrials.gov, number NCT00862043.

[Advances in heart failure]. / Temas de actualidad en insuficiencia cardiaca.

This article reports on the most significant developments in the field of heart failure in the past year. Principal innovations in the management of chronic heart failure are explained, including the most important features of new management models for patients with chronic heart failure and the main advances in drug therapy and in the use of and indications for cardiac devices in these patients. In addition, recent progress in the treatment of advanced heart failure, with particular emphasis on acute heart failure, is reviewed. Novel approaches to the surgical management of patients with heart failure, including new contributions in the field of the circulatory support, are also highlighted in this update.