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AIM: The RESHAPE-HF2 trial is designed to assess the efficacy and safety of the MitraClip device system for the treatment of clinically important functional mitral regurgitation (FMR) in patients with heart failure (HF). This report describes the baseline characteristics of patients enrolled in the RESHAPE-HF2 trial compared to those enrolled in the COAPT and MITRA-FR trials. METHODS AND RESULTS: The RESHAPE-HF2 study is an investigator-initiated, prospective, randomized, multicentre trial including patients with symptomatic HF, a left ventricular ejection fraction (LVEF) between 20% and 50% with moderate-to-severe or severe FMR, for whom isolated mitral valve surgery was not recommended. Patients were randomized 1:1 to a strategy of delivering or withholding MitraClip. Of 506 patients randomized, the mean age of the patients was 70 ± 10 years, and 99 of them (20%) were women. The median EuroSCORE II was 5.3 (2.8-9.0) and median plasma N-terminal pro-B-type natriuretic peptide (NT-proBNP) was 2745 (1407-5385) pg/ml. Most patients were prescribed beta-blockers (96%), diuretics (96%), angiotensin-converting enzyme inhibitors/angiotensin receptor blockers/angiotensin receptor-neprilysin inhibitors (82%) and mineralocorticoid receptor antagonists (82%). The use of sodium-glucose cotransporter 2 inhibitors was rare (7%). Cardiac resynchronization therapy (CRT) devices had been previously implanted in 29% of patients. Mean LVEF, left ventricular end-diastolic volume and effective regurgitant orifice area (EROA) were 31 ± 8%, 211 ± 76 ml and 0.25 ± 0.08 cm2, respectively, whereas 44% of patients had mitral regurgitation severity of grade 4+. Compared to patients enrolled in COAPT and MITRA-FR, those enrolled in RESHAPE-HF2 were less likely to have mitral regurgitation grade 4+ and, on average, HAD lower EROA, and plasma NT-proBNP and higher estimated glomerular filtration rate, but otherwise had similar age, comorbidities, CRT therapy and LVEF. CONCLUSION: Patients enrolled in RESHAPE-HF2 represent a third distinct population where MitraClip was tested in, that is one mainly comprising of patients with moderate-to-severe FMR instead of only severe FMR, as enrolled in the COAPT and MITRA-FR trials. The results of RESHAPE-HF2 will provide crucial insights regarding broader application of the transcatheter edge-to-edge repair procedure in clinical practice.
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Insuficiencia Cardíaca , Insuficiencia de la Válvula Mitral , Índice de Severidad de la Enfermedad , Volumen Sistólico , Humanos , Insuficiencia de la Válvula Mitral/cirugía , Insuficiencia de la Válvula Mitral/fisiopatología , Insuficiencia de la Válvula Mitral/complicaciones , Femenino , Masculino , Insuficiencia Cardíaca/fisiopatología , Insuficiencia Cardíaca/terapia , Insuficiencia Cardíaca/complicaciones , Anciano , Estudios Prospectivos , Volumen Sistólico/fisiología , Resultado del Tratamiento , Persona de Mediana Edad , Fragmentos de Péptidos/sangre , Válvula Mitral/cirugía , Péptido Natriurético Encefálico/sangre , Implantación de Prótesis de Válvulas Cardíacas/métodos , Función Ventricular Izquierda/fisiologíaRESUMEN
BACKGROUND: The TIM-HF2 study demonstrated that remote patient management (RPM) in a well-defined heart failure (HF) population reduced the percentage of days lost due to unplanned cardiovascular hospital admissions or all-cause death during 1-year follow-up (hazard ratio 0.80) and all-cause mortality alone (HR 0.70). Higher rates of hospital admissions and mortality have been reported in HF patients with diabetes compared with HF patients without diabetes. Therefore, in a post-hoc analysis of the TIM-HF2 study, we investigated the efficacy of RPM in HF patients with diabetes. METHODS: TIM-HF2 study was a randomized, controlled, unmasked (concealed randomization), multicentre trial, performed in Germany between August 2013 and May 2018. HF-Patients in NYHA class II/III who had a HF-related hospital admission within the previous 12 months, irrespective of left ventricular ejection fraction, and were randomized to usual care with or without added RPM and followed for 1 year. The primary endpoint was days lost due to unplanned cardiovascular hospitalization or due to death of any cause. This post-hoc analysis included 707 HF patients with diabetes. RESULTS: In HF patients with diabetes, RPM reduced the percentage of days lost due to cardiovascular hospitalization or death compared with usual care (HR 0.66, 95% CI 0.48-0.90), and the rate of all-cause mortality alone (HR 0.52, 95% CI 0.32-0.85). RPM was also associated with an improvement in quality of life (mean difference in change in global score of Minnesota Living with Heart Failure Questionnaire score (MLHFQ): - 3.4, 95% CI - 6.2 to - 0.6). CONCLUSION: These results support the use of RPM in HF patients with diabetes. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov NCT01878630.
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Diabetes Mellitus , Insuficiencia Cardíaca , Telemedicina , Humanos , Insuficiencia Cardíaca/mortalidad , Insuficiencia Cardíaca/diagnóstico , Insuficiencia Cardíaca/terapia , Insuficiencia Cardíaca/fisiopatología , Masculino , Femenino , Anciano , Persona de Mediana Edad , Factores de Tiempo , Resultado del Tratamiento , Alemania/epidemiología , Diabetes Mellitus/mortalidad , Diabetes Mellitus/diagnóstico , Diabetes Mellitus/terapia , Factores de Riesgo , Hospitalización , Causas de Muerte , Anciano de 80 o más Años , Admisión del PacienteRESUMEN
Implantable devices form an integral part of the management of patients with heart failure (HF) and provide adjunctive therapies in addition to cornerstone drug treatment. Although the number of these devices is growing, only few are supported by robust evidence. Current devices aim to improve haemodynamics, improve reverse remodelling, or provide electrical therapy. A number of these devices have guideline recommendations and some have been shown to improve outcomes such as cardiac resynchronization therapy, implantable cardioverter-defibrillators and long-term mechanical support. For others, more evidence is still needed before large-scale implementation can be strongly advised. Of note, devices and drugs can work synergistically in HF as improved disease control with devices can allow for further optimization of drug therapy. Therefore, some devices might already be considered early in the disease trajectory of HF patients, while others might only be reserved for advanced HF. As such, device therapy should be integrated into HF care programmes. Unfortunately, implementation of devices, including those with the greatest evidence, in clinical care pathways is still suboptimal. This clinical consensus document of the Heart Failure Association (HFA) and European Heart Rhythm Association (EHRA) of the European Society of Cardiology (ESC) describes the physiological rationale behind device-provided therapy and also device-guided management, offers an overview of current implantable device options recommended by the guidelines and proposes a new integrated model of device therapy as a part of HF care.
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Terapia de Resincronización Cardíaca , Cardiología , Desfibriladores Implantables , Insuficiencia Cardíaca , Humanos , Insuficiencia Cardíaca/terapiaRESUMEN
The widespread adoption of mobile technologies offers an opportunity for a new approach to post-discharge care for patients with heart failure (HF). By enabling non-invasive remote monitoring and two-way, real-time communication between the clinic and home-based patients, as well as a host of other capabilities, mobile technologies have a potential to significantly improve remote patient care. This literature review summarizes clinical evidence related to virtual healthcare (VHC), defined as a care team + connected devices + a digital solution in post-release care of patients with HF. Searches were conducted on Embase (06/12/2020). A total of 171 studies were included for data extraction and evidence synthesis: 96 studies related to VHC efficacy, and 75 studies related to AI in HF. In addition, 15 publications were included from the search on studies scaling up VHC solutions in HF within the real-world setting. The most successful VHC interventions, as measured by the number of reported significant results, were those targeting reduction in rehospitalization rates. In terms of relative success rate, the two most effective interventions targeted patient self-care and all-cause hospital visits in their primary endpoint. Among the three categories of VHC identified in this review (telemonitoring, remote patient management, and patient self-empowerment) the integrated approach in remote patient management solutions performs the best in decreasing HF patients' re-admission rates and overall hospital visits. Given the increased amount of data generated by VHC technologies, artificial intelligence (AI) is being investigated as a tool to aid decision making in the context of primary diagnostics, identifying disease phenotypes, and predicting treatment outcomes. Currently, most AI algorithms are developed using data gathered in clinic and only a few studies deploy AI in the context of VHC. Most successes have been reported in predicting HF outcomes. Since the field of VHC in HF is relatively new and still in flux, this is not a typical systematic review capturing all published studies within this domain. Although the standard methodology for this type of reviews was followed, the nature of this review is qualitative. The main objective was to summarize the most promising results and identify potential research directions.
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BACKGROUND: The randomized controlled clinical trial "TIM-HF2" investigated the benefit of telemonitoring in chronic heart failure. The health economic evaluation of this intervention was based on routine data from statutory health insurance (SHI) funds. Since participants were recruited independently of their SHI affiliation, there was a large number of potential data-providing SHI funds. This resulted in both organizational and methodological challenges, from participation of the data providers to data preparation. METHOD: The procedures are described from study planning and data acquisition to data review and processing in the TIM-HF2 trial. Based on the identification of potential problems for data completeness and data quality, possible solutions have been derived. RESULTS: In total, participants were insured with 49 different SHI funds, which provided routine data for a total of 1450 participants. About half of all initial data deliveries were correct. The most common problems in data preparation occurred in the machine readability of the data. Success factors for a high level of data completeness were close communication with the SHI funds and a high level of time and personnel commitment to intensive data checking and preparation. DISCUSSION: Based on the experience of the TIM-HF2 trial, a high heterogeneity has been detected in data management and transmission of routine data. Universally applicable data descriptions are desired to improve data access, quality, and usability for research purposes.
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Administración Financiera , Seguro de Salud , Humanos , Alemania , Programas Nacionales de Salud , Informe de InvestigaciónRESUMEN
AIMS: The benefit of non-invasive remote patient management (RPM) for patients with heart failure (HF) has been demonstrated. We evaluated the effect of left ventricular ejection fraction (LVEF) on treatment outcomes in the TIM-HF2 (Telemedical Interventional Management in Heart Failure II; NCT01878630) randomized trial. METHODS AND RESULTS: TIM-HF2 was a prospective, randomized, multicentre trial investigating the effect of a structured RPM intervention versus usual care in patients who had been hospitalized for HF within 12 months before randomization. The primary endpoint was the percentage of days lost due to all-cause death or unplanned cardiovascular hospitalization. Key secondary endpoints were all-cause and cardiovascular mortality. Outcomes were assessed by LVEF in guideline-defined subgroups of ≤40% (HF with reduced EF [HFrEF]), 41-49% (HF with mildly reduced EF [HFmrEF]), and ≥50% (HF with preserved EF [HFpEF]). Out of 1538 participants, 818 (53%) had HFrEF, 224 (15%) had HFmrEF, and 496 (32%) had HFpEF. Within each LVEF subgroup, the primary endpoint was lower in the treatment group, i.e. the incidence rate ratio [IRR] remained below 1.0. Comparing intervention and control group, the percentage of days lost was 5.4% versus 7.6% for HFrEF (IRR 0.72, 95% confidence interval [CI] 0.54-0.97), 3.3% versus 5.9% for HFmrEF (IRR 0.85, 95% CI 0.48-1.50) and 4.7% versus 5.4% for HFpEF (IRR 0.93, 95% CI 0.64-1.36). No interaction between LVEF and the randomized group became apparent. All-cause and cardiovascular mortality were also reduced by RPM in each subgroup with hazard ratios <1.0 across the LVEF spectrum for both endpoints. CONCLUSION: In the clinical set-up deployed in the TIM-HF2 trial, RPM appeared effective irrespective of the LVEF-based HF phenotype.
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Insuficiencia Cardíaca , Humanos , Volumen Sistólico , Función Ventricular Izquierda , Estudios Prospectivos , Resultado del Tratamiento , PronósticoRESUMEN
Although the development of therapies and tools for the improved management of heart failure (HF) continues apace, day-to-day management in clinical practice is often far from ideal. A Cardiovascular Round Table workshop was convened by the European Society of Cardiology (ESC) to identify barriers to the optimal implementation of therapies and guidelines and to consider mitigation strategies to improve patient outcomes in the future. Key challenges identified included the complexity of HF itself and its treatment, financial constraints and the perception of HF treatments as costly, failure to meet the needs of patients, suboptimal outpatient management, and the fragmented nature of healthcare systems. It was discussed that ongoing initiatives may help to address some of these barriers, such as changes incorporated into the 2021 ESC HF guideline, ESC Heart Failure Association quality indicators, quality improvement registries (e.g. EuroHeart), new ESC guidelines for patients, and the universal definition of HF. Additional priority action points discussed to promote further improvements included revised definitions of HF 'phenotypes' based on trial data, the development of implementation strategies, improved affordability, greater regulator/payer involvement, increased patient education, further development of patient-reported outcomes, better incorporation of guidelines into primary care systems, and targeted education for primary care practitioners. Finally, it was concluded that overarching changes are needed to improve current HF care models, such as the development of a standardized pathway, with a common adaptable digital backbone, decision-making support, and data integration, to ensure that the model 'learns' as the management of HF continues to evolve.
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Cardiología , Insuficiencia Cardíaca , Humanos , Insuficiencia Cardíaca/terapiaRESUMEN
Graphical AbstractAdherence to cardiac rehabilitation following a primary event has been demonstrated to improve quality of life, increase functional capacity, and decrease hospitalizations and mortality. Mobile technologies offer an opportunity to improve both the quality and utilization of cardiac rehabilitation, and recent clinical studies investigated this technology. This literature review summarizes the current use of mobile health, wearable activity monitors (WAMs), and other multi-component technologies deployed to support home-based virtual cardiac rehabilitation. The methodology was adapted from the Cochrane Handbook for Systematic Reviews of Interventions. We identified 2094 records, of which 113 were eligible for qualitative analysis. Different virtual cardiac rehabilitation solutions were implemented in the studies: (i) multi-component interventions in 48 studies (42.5%), (ii) WAMs in 27 studies (23.9%), (iii) web-based communications solutions, and (iv) mobile apps, both in 19 studies (16.4%). Functional capacity was the most frequently reported primary outcome (k = 37, 32.7%), followed by user adherence/compliance (k = 35, 31.0%), physical activity (k = 27, 23.9%), and quality of life (k = 14, 12.4%). Studies provided a mixed assessment of the efficacy of virtual cardiac rehabilitation in attaining either significant improvements over baseline or significant improvements in outcomes compared with conventional rehabilitation. Efficacy outcomes with virtual cardiac rehabilitation sometimes improve on the centre-based outcomes; however, superior clinical efficacy may not necessarily be the only outcome of interest. The promise of virtual cardiac rehabilitation includes the potential for increased user adherence and longer-term patient engagement. If these outcomes can be improved, that would be a significant justification for using this technology.
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AIMS: Remote patient management (RPM) in heart failure (HF) patients has beneficial clinical effects. This analysis investigates the effects of RPM used in the Telemedical Interventional Management in Heart Failure II (TIM-HF2) trial on HF-specific self-care. METHODS AND RESULTS: From 2013 to 2017, 1538 HF outpatients (age 70.3 ± 10.5 years, 70% men, 52%/47% NYHA II/III, 65% LVEF ≤45%) with a recent HF hospitalization were included to the study and randomized to usual care (UC) plus RPM (n = 796) or UC only (n = 775), with a 12-month follow-up. Self-reported self-care behaviour at baseline and at end of study was assessed with the 9-item European Heart Failure Self-care Behaviour Scale (EHFScBS-9), obtaining 1321 patients with valid baseline and follow-up questionnaires for the analysis. EHFScBS-9 sum scores increased in the RPM group (n = 667) from 78.7 ± 17 to 84.5 ± 14 and in the UC group (n = 654) from 79.0 ± 17 to 80.0 ± 16 from baseline to 12 months [difference in means (MD) 4.58 (3.02, 6.14); P < 0.001] with highest improvement [8.66 (3.52; 13.81)] in patients living alone and having an inadequate (<70) baseline EHFScBS-9. There were differences between both groups in item 'I weight myself every day' [MD -1.13 (-1.24, -1.02); P < 0.001] and item 'I take my medication as prescribed' [MD -0.06 (-0.10, -0.01); P = 0.014]. No correlation was found between the EHFScBS-9 score and the efficacy of RPM on the TIM-HF2 primary endpoint of percentage of days lost due to unplanned cardiovascular hospitalization or death of any cause. CONCLUSIONS: RPM improves HF-specific self-care behaviour by achieving a better adherence to recommended HF regimen. REGISTRATION: ClinicalTrials.gov: NCT01878630.
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Insuficiencia Cardíaca , Telemedicina , Masculino , Humanos , Persona de Mediana Edad , Anciano , Anciano de 80 o más Años , Femenino , Autocuidado , Telemedicina/métodos , Hospitalización , Encuestas y Cuestionarios , Insuficiencia Cardíaca/tratamiento farmacológicoRESUMEN
Aims: The majority of patients with severe aortic stenosis (AS) planned for transcatheter aortic valve implantation (TAVI) are elective outpatients. During the COVID-19 pandemic, the time between the heart team's decision and TAVI increased due to limited healthcare resources. We therefore implemented telemedical approaches to identify AS patients at risk for clinical deterioration during the waiting time. The purpose of the prospective, randomized, controlled ResKriVer-TAVI study (DRKS00027842) is to investigate whether a digital concept of telemedical interventional management (TIM) in AS patients waiting for TAVI improves the clinical outcomes. In the present article, we report the study protocol of the ResKriVer-TAVI trial. Methods: ResKriVer-TAVI will enroll AS patients planned for elective TAVI. Randomization to the TIM group or standard care will be made on the day of the heart team's decision. TIM will include a daily assessment of weight, blood pressure, a 2-channel electrocardiogram, peripheral capillary oxygen saturation, and a self-rated health status until admission for TAVI. TIM will allow optimization of medical therapy or an earlier admission for TAVI if needed. Standard care will not include any additional support for patients with AS. All patients of the TIM group will receive a rule-based TIM including standard operating procedures when a patient is crossing prespecified values of a vital sign. Results: The primary endpoint consists of days lost due to cardiovascular hospitalization and death of any cause within 180 days after the heart team's decision. Major secondary endpoints include all-cause mortality within 365 days, the number of telemedical interventions, and adherence to TIM. Follow-up visits will be conducted at admission for TAVI as well as 6 and 12 months after the heart team's decision. Conclusions: ResKriVer-TAVI will be the first randomized, controlled trial investigating a telemedical approach before TAVI in patients with AS. We hypothesize that primary and secondary endpoints of AS patients with TIM will be superior to standard care. The study will serve to establish TIM in the clinical routine and to increase the resilience of TAVI centers in situations with limited healthcare resources.
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AIMS: Telemedical interventions in heart failure patients intend to avoid unfavourable, indication-related events by an early, individualized care, which reacts to the current patients need. However, telemedical support is an expensive intervention, and usually only patients with high risk for unfavourable follow-up events will be able to profit from it. Möckel et al. therefore adapted a new design which we call 'prognostic-efficacy-combination design'. This design allows to define a biomarker cut-off and to perform a randomized controlled trial (RCT) in a biomarker-selected population within a single study. However, so far, it has not been evaluated if this double use of the control group for biomarker cut-off definition and efficacy assessment within the RCT leads to a bias in treatment effect estimation. In this methodological research work, we therefore want to evaluate whether the 'prognostic-efficacy-combination design' leads to biased treatment effect estimates and also compare it to alternative designs. If there is a bias, we further want to analyse its magnitude under different parameter settings. METHODS: We perform a systematic Monte Carlo simulation study to investigate among others potential bias, root mean square error and sensitivity, and specificity as well as the total treatment effect estimate in various realistic trial scenarios that mimic and vary the true data characteristics of the published TIM-HF2 Trial. In particular, we vary the event proportion, the sample size, the biomarker distribution, and the lower bound for the sensitivity. RESULTS: The results show that indeed the proposed design leads to some bias in the effect estimators, indicating an overestimation of the effect. However, this bias is relatively small in most scenarios. CONCLUSIONS: The 'prognostic-efficacy-combination design' can generally be recommended for clinical applications due to its efficiency compared to two separate trials. We recommend a sufficiently large sample size depending on the trial scenario. Our simulation code can be adapted to explore suitable sample sizes for other settings.
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Proyectos de Investigación , Humanos , Biomarcadores , PronósticoRESUMEN
Background: Remote patient management (RPM) in heart failure (HF) patients has been investigated in several prospective randomized trials. The Telemedical Interventional Management in Heart Failure II (TIM-HF2)-trial showed reduced all-cause mortality and hospitalizations in heart failure (HF) patients using remote patient management (RPM) vs. usual care (UC). We report the trial's results for prespecified eGFR-subgroups. Methods: TIM-HF2 was a prospective, randomized, controlled, parallel-group, unmasked (with randomization concealment), multicenter trial. A total of 1,538 patients with stable HF were enrolled in Germany from 2013 to 2017 and randomized to RPM (+UC) or UC. Using CKD-EPI-formula at baseline, prespecified subgroups were defined. In RPM, patients transmitted their vital parameters daily. The telemedical center reviewed and co-operated with the patient's General Practitioner (GP) and cardiologist. In UC, patients were treated by their GPs or cardiologist applying the current guidelines for HF management and treatment. The primary endpoint was the percentage of days lost due to unplanned cardiovascular hospitalizations or death, secondary outcomes included hospitalizations, all-cause, and cardiovascular mortality. Results: Our sub analysis showed no difference between RPM and UC in both eGFR-subgroups for the primary endpoint (<60 ml/min/1.73 m2: 40.9% vs. 43.6%, p = 0.1, ≥60 ml/min/1.73 m2 26.5 vs. 29.3%, p = 0.36). In patients with eGFR < 60 ml/min/1.73 m2, 1-year-survival was higher in RPM than UC (89.4 vs. 84.6%, p = 0.02) with an incident rate ratio (IRR) 0.67 (p = 0.03). In the recurrent event analysis, HF hospitalizations and all-cause death were lower in RPM than UC in both eGFR-subgroups (<60 ml/min/1.73 m2: IRR 0.70, p = 0.02; ≥60 ml/min/1.73 m2: IRR 0.64, p = 0.04). In a cox regression analysis, age, NT-pro BNP, eGFR, and BMI were associated with all-cause mortality. Conclusion: RPM may reduce all-cause mortality and HF hospitalizations in patients with HF and eGFR < 60 ml/min/1.73 m2. HF hospitalizations and all-cause death were lower in RPM in both eGFR-subgroups in the recurrent event analysis. Further studies are needed to investigate and confirm this finding.
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BACKGROUND: Noninvasive remote patient management (RPM) in patients with heart failure (HF) has been shown to reduce the days lost due to unplanned cardiovascular hospital admissions and all-cause mortality in the Telemedical Interventional Management in Heart Failure II trial (TIM-HF2). The health economic implications of these findings are the focus of the present analyses from the payer perspective. METHODS AND RESULTS: A total of 1538 participants of the TIM-HF2 randomized controlled trial were assigned to the RPM and Usual Care group. Health claims data were available for 1450 patients (n = 715 RPM group, n = 735 Usual Care group), which represents 94.3% of the original TIM-HF2 patient population, were linked to primary data from the study documentation and evaluated in terms of the health care cost, total cost (accounting for intervention costs), costs per day alive and out of hospital (DAOH), and cost per quality-adjusted life year (QALY). The average health care costs per patient year amounted to 14,412 (95% CI 13,284-15,539) in the RPM group and 17,537 (95% CI 16,179-18,894) in the UC group. RPM led to cost savings of 3125 per patient year (p = 0.001). After including the intervention costs, a cost saving of 1758 per patient year remained (p = 0.048). CONCLUSION: The additional noninvasive telemedical interventional management in patients with HF was cost-effective compared to standard care alone, since such intervention was associated with overall cost savings and superior clinical effectiveness.
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Insuficiencia Cardíaca , Telemedicina , Humanos , Análisis Costo-Beneficio , Insuficiencia Cardíaca/terapia , Telemedicina/métodos , Hospitalización , Costos de la Atención en Salud , Años de Vida Ajustados por Calidad de VidaRESUMEN
Aims: To evaluate the rate of new-onset atrial fibrillation (AF) and the potential improved outcome in heart failure (HF) patients using non-invasive remote patient management (RPM) compared with usual care (UC). Methods and results: This analysis assessed a subgroup of 1538 patients of the TIM-HF2 trial with chronic HF, New York Heart Association Class II or III, admission to hospital for HF within 12 months before randomization, and a left ventricular ejection fraction (LVEF) of 45% or lower. Patients with AF in the baseline electrocardiogram (ECG), with an implanted cardiac device, a history of ablation therapy, and recent anticoagulation were excluded, leaving 347 patients for final analysis (RPM = 175; UC = 172). The percentage of days lost due to unplanned cardiovascular hospitalization or death of any cause (primary endpoint of TIM-HF2), the rate of newly detected AF, and the hospitalization rate due to AF were analysed. For patients with new AF, there was a significant reduction for the primary endpoint in the RPM group [5.5%, 95% confidence interval (CI) 0-11.6 vs. UC: 14.6%, 95% CI 8.0-21.2; P < 0.001]. Within the first 3 months, the detection rate of new AF was significantly higher in the RPM group (5.1%) compared with UC (1.2%), P = 0.035. After 1 year, 23 patients (13.1%) assigned to RPM and 12 patients (7.0%) assigned to UC had newly detected AF, P = 0.056. Unplanned hospitalizations related to AF were significantly lower in the RPM group (2 out of 23 patients vs. UC: 10 out of 12 patients; P < 0.001). Conclusion: In this subgroup of HF patients in the TIM-HF2 trial, non-invasive daily ECG transmission leads to a four times higher detection rate of new AF compared with UC. This was associated with a significant reduction of days lost due to unplanned cardiovascular hospitalizations, especially hospitalizations related to AF.
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AIMS: Control of pulmonary pressures monitored remotely reduced heart failure hospitalizations mainly by lowering filling pressures through the use of loop diuretics. Sacubitril/valsartan improves heart failure outcomes and increases the kidney sensitivity for diuretics. We explored whether sacubitril/valsartan is associated with less utilization of loop diuretics in patients guided with haemodynamic monitoring in the CardioMEMS European Monitoring Study for Heart Failure (MEMS-HF). METHODS AND RESULTS: The MEMS-HF population (n = 239) was separated by the use of sacubitril/valsartan (n = 68) or no use of it (n = 164). Utilization of diuretics and their doses was prespecified in the protocol and was monitored in both groups. Multivariable regression, ANCOVA, and a generalized linear model were used to fit baseline covariates with furosemide equivalents and changes for 12 months. MEMS-HF participants (n = 239) were grouped in sacubitril/valsartan users [n = 68, 64 ± 11 years, left ventricular ejection fraction (LVEF) 25 ± 9%, cardiac index (CI) 1.89 ± 0.4 L/min/m2 ] vs. non-users (n = 164, 70 ± 10 years, LVEF 36 ± 16%, CI 2.11 ± 0.58 L/min/m2 , P = 0.0002, P < 0.0001, and P = 0.0015, respectively). In contrast, mean pulmonary artery pressure (PAP) values were comparable between groups (29 ± 11 vs. 31 ± 11 mmHg, P = 0.127). Utilization of loop diuretics was lower in patients taking sacubitril/valsartan compared with those without (P = 0.01). Significant predictor of loop diuretic use was a history of renal failure (P = 0.005) but not age (P = 0.091). After subjects were stratified by sacubitril/valsartan or other diuretic use, PAP was nominally, but not significantly lower in sacubitril/valsartan-treated patients (baseline: P = 0.52; 6 months: P = 0.07; 12 months: P = 0.53), while there was no difference in outcome or PAP changes. This difference was observed despite lower CI (P = 0.0015). Comparable changes were not observed for other non-loop diuretics (P = 0.21). CONCLUSIONS: In patients whose treatment was guided by remote PAP monitoring, concomitant use of sacubitril/valsartan was associated with reduced utilization of loop diuretics, which could potentially be relevant for outcomes.
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Monitorización Hemodinámica , Inhibidores del Simportador de Cloruro Sódico y Cloruro Potásico , Aminobutiratos , Antagonistas de Receptores de Angiotensina/uso terapéutico , Compuestos de Bifenilo , Humanos , Arteria Pulmonar , Volumen Sistólico , Tetrazoles/uso terapéutico , Valsartán/uso terapéutico , Función Ventricular IzquierdaRESUMEN
Cardiovascular (CV) engagement in coronavirus disease 2019 (COVID-19) is a huge determinant of prognosis during the acute phase of the disease. However, little is known about the potential chronic implications of the late phase of COVID-19 and about the appropriate approach to these patients. Heart failure, type 1 and type 2 myocardial infarction, arrhythmias, myocarditis, pulmonary fibrosis, and thrombosis have been shown to be related to severe acute respiratory syndrome coronavirus 2 infection, and a 'long COVID-19' illness has been recognized with fatigue, chest pain, and dyspnoea among the most frequent symptoms reported after discharge from hospital. This paper focuses on some open questions that cardiologists are going to face during the next months in a general cardiology outpatient clinic, in particular how to evaluate a 'post-COVID' patient during follow-up of CV complications of the acute phase and how to manage new CV symptoms that could be the consequence, at least in part, of heart/vessels and/or lung involvement of the previous virus infection. Present symptoms and signs, history of previous CV disease (both preceding COVID-19 and occurring during viral infection), and specific laboratory and imaging measurements during the acute phase may be of interest in focusing on how to approach the clinical evaluation of a post-COVID patient and how to integrate in our standard of care the new information on COVID-19, possibly in a multidisciplinary view. Dealing with the increased COVID-associated CV risk burden and becoming acquainted with potential new e-cardiology approaches aimed at integrating the cardiology practice are relevant new challenges brought by severe acute respiratory syndrome coronavirus 2 infection and its sequelae.
Asunto(s)
COVID-19 , Cardiología , COVID-19/complicaciones , Humanos , Pandemias , SARS-CoV-2 , Síndrome Post Agudo de COVID-19RESUMEN
AIMS: Telemedical emergency services for heart failure (HF) patients are usually provided during business hours. However, many emergencies occur outside of business hours. This study evaluates if a 24/7 telemedical emergency service is needed for the remote management of high-risk HF patients. METHODS AND RESULTS: The study included 1119 patients merged from the TIM-HF and TIM-HF2 trials [age 69 ± 11, 73% male, left ventricular ejection fraction 37% ± 13, 557 New York Heart Association (NYHA) II/562 NYHA III]. Patients received a 24/7 physician-guided emergency service provided by the telemedical centre (TMC) in addition to remote management within business hours. During emergency calls, patient status, symptoms, electronic patient record, and instant telemonitoring data were evaluated by the TMC physician. Following diagnosis, patients were referred for hospital admission or instructed to stay at home. Apart from the TMC, patients could place a call to the public emergency service at any time. Seven hundred sixty-eight emergency calls were placed over 1383 patient years (0.56 calls/patient year). Five hundred twenty-six calls (69%) occurred outside business hours. There were 146 (19%) emergency calls for worsening HF, 297 (39%) other cardiovascular, and 325 (42%) non-cardiac causes, with a similar pattern inside and outside business hours. Of the 1119 patients, 417 (37%) placed at least one emergency call. Patients with NYHA Class III, higher N-terminal prohormone of brain natriuretic peptide (>1.400 pg/mL) levels, ischaemic aetiology of HF, implanted defibrillator, and impaired renal function had a higher probability of placing emergency calls. During study follow-up, patients who made an emergency call had a higher all-cause mortality (22% vs. 11%, P = 0.007 in TIM-HF; 16% vs. 4%, P < 0.001 in TIM-HF2) and more unplanned hospitalizations (324 vs. 162, P < 0.001 in TIM-HF; 545 vs. 180, P < 0.001 in TIM-HF2). Of the total 1,211 unplanned hospital admissions, 492 (41%) were initiated by a patient emergency call. Three hundred seventy-nine calls (49%) were placed to the TMC, whereas 389 calls (51%) were made to the public emergency service. Three hundred twenty-six (84%) of the calls to the public emergency service resulted in acute hospitalizations. The TMC initiated 202 (53%) hospital admissions; 177 (47%) patients were advised to stay at home. All patients that remained at home were alive during a prespecified safety period of 7 days post-call. Diagnoses made by the TMC physician were confirmed in 83% of cases by the hospital. CONCLUSION: A telemedical emergency service for high-risk HF patients is safe and should operate 24/7 to reduce unplanned hospitalizations. Emergency calls could be considered as a marker for higher morbidity and mortality.