RESUMEN
Guideline-directed medical therapy (GDMT) has clear benefits on morbidity and mortality in patients with heart failure; however, GDMT use remains low. In the multicenter, open-label, investigator-initiated ADMINISTER trial, patients (n = 150) diagnosed with heart failure and reduced ejection fraction (HFrEF) were randomized (1:1) to receive usual care or a strategy using digital consults (DCs). DCs contained (1) digital data sharing from patient to clinician (pharmacotherapy use, home-measured vital signs and Kansas City Cardiomyopathy Questionnaires); (2) patient education via a text-based e-learning; and (3) guideline recommendations to all treating clinicians. All remotely gathered information was processed into a digital summary that was available to clinicians in the electronic health record before every consult. All patient interactions were standardly conducted remotely. The primary endpoint was change in GDMT score over 12 weeks (ΔGDMT); this GDMT score directly incorporated all non-conditional class 1 indications for HFrEF therapy with equal weights. The ADMINISTER trial met its primary outcome of achieving a higher GDMT in the DC group after a follow-up of 12 weeks (ΔGDMT score in the DC group: median 1.19, interquartile range (0.25, 2.3) arbitrary units versus 0.08 (0.00, 1.00) in usual care; P < 0.001). To our knowledge, this is the first multicenter randomized controlled trial that proves a DC strategy is effective to achieve GDMT optimization. ClinicalTrials.gov registration: NCT05413447 .
Asunto(s)
Insuficiencia Cardíaca , Humanos , Insuficiencia Cardíaca/tratamiento farmacológico , Insuficiencia Cardíaca/terapia , Masculino , Femenino , Anciano , Persona de Mediana Edad , Volumen Sistólico , Derivación y ConsultaRESUMEN
PURPOSEOF REVIEW: Guideline-directed medical therapy (GDMT) underuse is common in heart failure (HF) patients. Digital solutions have the potential to support medical professionals to optimize GDMT prescriptions in a growing HF population. We aimed to review current literature on the effectiveness of digital solutions on optimization of GDMT prescriptions in patients with HF. RECENT FINDINGS: We report on the efficacy, characteristics of the study, and population of published digital solutions for GDMT optimization. The following digital solutions are discussed: teleconsultation, telemonitoring, cardiac implantable electronic devices, clinical decision support embedded within electronic health records, and multifaceted interventions. Effect of digital solutions is reported in dedicated studies, retrospective studies, or larger studies with another focus that also commented on GDMT use. Overall, we see more studies on digital solutions that report a significant increase in GDMT use. However, there is a large heterogeneity in study design, outcomes used, and populations studied, which hampers comparison of the different digital solutions. Barriers, facilitators, study designs, and future directions are discussed. There remains a need for well-designed evaluation studies to determine safety and effectiveness of digital solutions for GDMT optimization in patients with HF. Based on this review, measuring and controlling vital signs in telemedicine studies should be encouraged, professionals should be actively alerted about suboptimal GDMT, the researchers should consider employing multifaceted digital solutions to optimize effectiveness, and use study designs that fit the unique sociotechnical aspects of digital solutions. Future directions are expected to include artificial intelligence solutions to handle larger datasets and relieve medical professional's workload.
Asunto(s)
Insuficiencia Cardíaca , Telemedicina , Humanos , Insuficiencia Cardíaca/tratamiento farmacológico , Inteligencia Artificial , Estudios Retrospectivos , Prescripciones , Volumen SistólicoRESUMEN
AIMS: Many heart failure (HF) patients do not receive optimal guideline-directed medical therapy (GDMT) despite clear benefit on morbidity and mortality outcomes. Digital consults (DCs) have the potential to improve efficiency on GDMT optimization to serve the growing HF population. The investigator-initiated ADMINISTER trial was designed as a pragmatic multicenter randomized controlled open-label trial to evaluate efficacy and safety of DC in patients on HF treatment. METHODS AND RESULTS: Patients (n = 150) diagnosed with HF with a reduced ejection fraction will be randomized to DC or standard care (1:1). The intervention group receives multifaceted DCs including (i) digital data sharing (e.g. exchange of pharmacotherapy use and home-measured vital signs), (ii) patient education via an e-learning, and (iii) digital guideline recommendations to treating clinicians. The consults are performed remotely unless there is an indication to perform the consult physically. The primary outcome is the GDMT prescription rate score, and secondary outcomes include time till full GDMT optimization, patient and clinician satisfaction, time spent on healthcare, and Kansas City Cardiomyopathy Questionnaire. Results will be reported in accordance to the CONSORT statement. CONCLUSIONS: The ADMINISTER trial will offer the first randomized controlled data on GDMT prescription rates, time till full GDMT optimization, time spent on healthcare, quality of life, and patient and clinician satisfaction of the multifaceted patient- and clinician-targeted DC for GDMT optimization.
Asunto(s)
Insuficiencia Cardíaca , Calidad de Vida , Humanos , Insuficiencia Cardíaca/tratamiento farmacológico , Insuficiencia Cardíaca/diagnóstico , Morbilidad , Ensayos Clínicos Pragmáticos como Asunto , Estudios Multicéntricos como Asunto , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
Background: The European Society of Cardiology 2019 Guidelines on chronic coronary syndrome (CCS) recommend echocardiographic measurement of the left ventricular function for risk stratification in all patients with CCS. Whereas CCS and valvular heart disease (VHD) share common pathophysiological pathways and risk factors, data on the impact of VHD in CCS patients are scarce. Methods: Clinical data including treatment and mortality of patients diagnosed with CCS who underwent comprehensive transthoracic echocardiography (TTE) in two tertiary centers were collected. The outcome was all-cause mortality. Data were analyzed with Kaplan-Meier curves and Cox proportional hazard analysis adjusting for significant covariables and time-dependent treatment. Results: Between 2014 and 2021 a total of 1,984 patients with CCS (59% men) with a median age of 65 years (interquartile range [IQR] 57-73) underwent comprehensive TTE. Severe VHD was present in 44 patients and moderate VHD in 325 patients. A total of 654 patients (33%) were treated with revascularization, 39 patients (2%) received valve repair or replacement and 299 patients (15%) died during the median follow-up time of 3.5 years (IQR 1.7-5.6). Moderate or severe VHD (hazard ratio = 1.33; 95% CI 1.02-1.72) was significantly associated with mortality risk, independent of LV function and other covariables, as compared to no/mild VHD. Conclusions: VHD has a significant impact on mortality in patients with CCS additional to LV dysfunction, which emphasizes the need for a comprehensive echocardiographic assessment in these patients.