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1.
Lancet ; 401(10394): 2113-2123, 2023 06 24.
Artículo en Inglés | MEDLINE | ID: mdl-37220768

RESUMEN

BACKGROUND: The effect of haemodynamic monitoring of pulmonary artery pressure has predominantly been studied in the USA. There is a clear need for randomised trial data from patients treated with contemporary guideline-directed-medical-therapy with long-term follow-up in a different health-care system. METHODS: MONITOR-HF was an open-label, randomised trial, done in 25 centres in the Netherlands. Eligible patients had chronic heart failure of New York Heart Association class III and a previous heart failure hospitalisation, irrespective of ejection fraction. Patients were randomly assigned (1:1) to haemodynamic monitoring (CardioMEMS-HF system, Abbott Laboratories, Abbott Park, IL, USA) or standard care. All patients were scheduled to be seen by their clinician at 3 months and 6 months, and every 6 months thereafter, up to 48 months. The primary endpoint was the mean difference in the Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score at 12 months. All analyses were by intention-to-treat. This trial was prospectively registered under the clinical trial registration number NTR7673 (NL7430) on the International Clinical Trials Registry Platform. FINDINGS: Between April 1, 2019, and Jan 14, 2022, we randomly assigned 348 patients to either the CardioMEMS-HF group (n=176 [51%]) or the control group (n=172 [49%]). The median age was 69 years (IQR 61-75) and median ejection fraction was 30% (23-40). The difference in mean change in KCCQ overall summary score at 12 months was 7·13 (95% CI 1·51-12·75; p=0·013) between groups (+7·05 in the CardioMEMS group, p=0·0014, and -0·08 in the standard care group, p=0·97). In the responder analysis, the odds ratio (OR) of an improvement of at least 5 points in KCCQ overall summary score was OR 1·69 (95% CI 1·01-2·83; p=0·046) and the OR of a deterioration of at least 5 points was 0·45 (0·26-0·77; p=0·0035) in the CardioMEMS-HF group compared with in the standard care group. The freedom of device-related or system-related complications and sensor failure were 97·7% and 98·8%, respectively. INTERPRETATION: Haemodynamic monitoring substantially improved quality of life and reduced heart failure hospitalisations in patients with moderate-to-severe heart failure treated according to contemporary guidelines. These findings contribute to the aggregate evidence for this technology and might have implications for guideline recommendations and implementation of remote pulmonary artery pressure monitoring. FUNDING: The Dutch Ministry of Health, Health Care Institute (Zorginstituut), and Abbott Laboratories.


Asunto(s)
Insuficiencia Cardíaca , Monitorización Hemodinámica , Humanos , Anciano , Arteria Pulmonar , Monitorización Hemodinámica/efectos adversos , Calidad de Vida , Insuficiencia Cardíaca/tratamiento farmacológico , Enfermedad Crónica
2.
Eur Heart J ; 44(37): 3658-3668, 2023 10 01.
Artículo en Inglés | MEDLINE | ID: mdl-37210750

RESUMEN

AIMS: Adjustment of treatment based on remote monitoring of pulmonary artery (PA) pressure may reduce the risk of hospital admission for heart failure (HF). We have conducted a meta-analysis of large randomized trials investigating this question. METHODS AND RESULTS: A systematic literature search was performed for randomized clinical trials with PA pressure monitoring devices in patients with HF. The primary outcome of interest was the total number of HF hospitalizations. Other outcomes assessed were urgent visits leading to treatment with intravenous diuretics, all-cause mortality, and composites. Treatment effects are expressed as hazard ratios, and pooled effect estimates were obtained applying random effects meta-analyses. Three eligible randomized clinical trials were identified that included 1898 outpatients in New York Heart Association functional classes II-IV, either hospitalized for HF in the prior 12 months or with elevated plasma NT-proBNP concentrations. The mean follow-up was 14.7 months, 67.8% of the patients were men, and 65.8% had an ejection fraction ≤40%. Compared to patients in the control group, the hazard ratio (95% confidence interval) for total HF hospitalizations in those randomized to PA pressure monitoring was 0.70 (0.58-0.86) (P = .0005). The corresponding hazard ratio for the composite of total HF hospitalizations, urgent visits and all-cause mortality was 0.75 (0.61-0.91; P = .0037) and for all-cause mortality 0.92 (0.73-1.16). Subgroup analyses, including ejection fraction phenotype, revealed no evidence of heterogeneity in the treatment effect. CONCLUSION: The use of remote PA pressure monitoring to guide treatment of patients with HF reduces episodes of worsening HF and subsequent hospitalizations.


Asunto(s)
Insuficiencia Cardíaca , Arteria Pulmonar , Masculino , Humanos , Femenino , Ensayos Clínicos Controlados Aleatorios como Asunto , Hospitalización , Enfermedad Crónica , Volumen Sistólico
3.
Expert Rev Med Devices ; 20(5): 349-356, 2023 May.
Artículo en Inglés | MEDLINE | ID: mdl-37070597

RESUMEN

INTRODUCTION: Chronic heart failure (HF) is characterized by high hospital admission rates. The CardioMEMSTM HF System is a pulmonary artery pressure sensor developed for remote hemodynamic monitoring to reduce HF hospitalizations. The device is FDA approved and CE marked, but clinical evidence for the CardioMEMS system is mainly based upon U.S. studies. Because of structural differences in HF care between the U.S. and Europe, it is important to study CardioMEMS efficacy in European setting on top of usual HF care and contemporary therapy. Several observational studies have been performed in Europe, but there is an unmet need for randomized clinical trials. AREAS COVERED: This review focuses on safety and efficacy data for CardioMEMS remote hemodynamic monitoring in European HF setting, and discusses important upcoming studies. EXPERT OPINION: For safety, data from European studies are in line with U.S. studies. Efficacy with regard to reduction of HF hospitalizations seems promising, but is merely based upon observational studies comparing pre- and post-implantation event rates. The first European randomized clinical trial (MONITOR HF) will provide efficacy data compared to actual standard care in a high-quality healthcare system with contemporary HF treatment and will provide important generalizable information to other European countries.


Asunto(s)
Monitoreo Ambulatorio de la Presión Arterial , Insuficiencia Cardíaca , Humanos , Enfermedad Crónica , Insuficiencia Cardíaca/terapia , Hospitalización , Europa (Continente) , Arteria Pulmonar , Ensayos Clínicos Controlados Aleatorios como Asunto
4.
Front Pharmacol ; 14: 1081579, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-36969869

RESUMEN

Aims: Implementation of guideline-recommended pharmacological treatment in heart failure (HF) patients remains challenging. In 2021, the European Heart Failure Association (HFA) published a consensus document in which patient profiles were created based on readily available patient characteristics and suggested that treatment adjusted to patient profile may result in better individualized treatment and improved guideline adherence. This study aimed to assess the distribution of these patient profiles and their treatment in a large real-world chronic HF cohort. Methods and results: The HFA combined categories of heart rate, blood pressure, presence of atrial fibrillation, chronic kidney disease, and hyperkalemia into eleven phenotypic patient profiles. A total of 4,455 patients with chronic HF and a left ventricular ejection fraction ≤40% with complete information on all characteristics were distributed over these profiles. In total, 1,640 patients (36.8%) could be classified into one of the HFA profiles. Three of these each comprised >5% of the population and consisted of patients with a heart rate >60 beats per minute with normal blood pressure (>90/60 mmHg) and no hyperkalemia. Conclusion: Nearly forty percent of a real-world chronic HF population could be distributed over the eleven patient profiles as suggested by the HFA. Phenotype-specific treatment recommendations are clinically relevant and important to further improve guideline implementation.

5.
ESC Heart Fail ; 10(2): 1481-1487, 2023 04.
Artículo en Inglés | MEDLINE | ID: mdl-36738129

RESUMEN

AIMS: Hyperkalaemia is observed frequently in heart failure (HF) patients and is associated with an impaired prognosis and underuse of mineralocorticoid receptor antagonists (MRAs). However, the effects of serum potassium on prescription of the full guideline recommended daily dose of 50 mg in real-world daily practice are unknown. Therefore, we investigated serum potassium and its association with the prescribed MRA dose in a large cohort of chronic HF patients. METHODS AND RESULTS: A total of 5346 patients with chronic HF with a left ventricular ejection fraction ≤40% from 34 Dutch outpatient HF clinics between 2013 and 2016 were analysed on serum potassium and MRA (spironolactone and eplenerone) dose. Data were stratified by potassium as a serum potassium level <4.0, 4.0 to 5.0 or >5.0 mmol/L. Multivariable logistic regression models were used to assess the association between serum potassium and MRA dose and to adjust for potential confounders. Mean serum potassium was 4.4 ± 0.5 mmol/L and hyperkalaemia (serum potassium >5.0 mmol/L) was present in 399 patients (7.5%). MRA was used in 3091 patients (58.1%). Patients with hyperkalaemia significantly less often received ≥100% of the target dose (50 mg) compared with patients with a serum potassium between 4.0-5.0 mmol/L and <4.0 mmol/L (7.7% vs. 9.5% vs. 13.6% respectively, P = 0.0078). In the multivariable regression analyses, patients with hyperkalaemia were significantly less likely to receive ≥100% of the target dose compared with patients with serum potassium 4.0-5.0 mmol/L (OR 0.38, 95% CI 0.15-0.97, P = 0.044). Additionally, a one unit increase in serum potassium was significantly associated with a lower odds of receiving ≥100% of the target dose (OR 0.69, 95% CI 0.49-0.98, P = 0.036). CONCLUSIONS: In this large registry of real-world chronic HF patients, both an increase in serum potassium and hyperkalaemia were associated with a lower odds of receiving the guideline-recommended MRA dose.


Asunto(s)
Insuficiencia Cardíaca , Hiperpotasemia , Humanos , Antagonistas de Receptores de Mineralocorticoides/uso terapéutico , Hiperpotasemia/inducido químicamente , Hiperpotasemia/epidemiología , Volumen Sistólico , Función Ventricular Izquierda , Insuficiencia Cardíaca/complicaciones , Potasio , Enfermedad Crónica
6.
Sensors (Basel) ; 23(3)2023 Jan 26.
Artículo en Inglés | MEDLINE | ID: mdl-36772403

RESUMEN

Chronic heart failure (HF) is associated with high hospital admission rates and has an enormous burden on hospital resources worldwide. Ideally, detection of worsening HF in an early phase would allow physicians to intervene timely and proactively in order to prevent HF-related hospitalizations, a concept better known as remote hemodynamic monitoring. After years of research, remote monitoring of pulmonary artery pressures (PAP) has emerged as the most successful technique for ambulatory hemodynamic monitoring in HF patients to date. Currently, the CardioMEMS and Cordella HF systems have been tested for pulmonary artery pressure monitoring and the body of evidence has been growing rapidly over the past years. However, several ongoing studies are aiming to fill the gap in evidence that is still very clinically relevant, especially for the European setting. In this comprehensive review, we provide an overview of all available evidence for PAP monitoring as well as a detailed discussion of currently ongoing studies and future perspectives for this promising technique that is likely to impact HF care worldwide.


Asunto(s)
Insuficiencia Cardíaca , Monitorización Hemodinámica , Humanos , Arteria Pulmonar , Monitoreo Ambulatorio de la Presión Arterial , Monitoreo Ambulatorio , Insuficiencia Cardíaca/diagnóstico , Enfermedad Crónica
7.
Eur J Clin Invest ; 53(7): e13976, 2023 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-36841951

RESUMEN

BACKGROUND: The aim of this study was to assess heart failure (HF) treatment in patients with and without obesity in a large contemporary real-world Western European cohort. METHODS: Patients with a left ventricular ejection fraction (LVEF) <50% and available information on body mass index (BMI) were selected from the CHECK-HF registry. The CHECK-HF registry included chronic HF patients in the period between 2013 and 2016 in 34 Dutch outpatient clinics. Patients were divided into BMI categories. Differences in HF medical treatment were analysed, and multivariable logistic regression analysis (dichotomized as BMI <30 kg/m2 and ≥30 kg/m2 ) was performed. RESULTS: Seven thousand six hundred seventy-one patients were included, 1284 (16.7%) had a BMI ≥30 kg/m2 , and 618 (8.1%) had a BMI ≥35 kg/m2 . Median BMI was 26.4 kg/m2 . Patients with obesity were younger and had a higher rate of comorbidities such as diabetes mellitus, hypertension and obstructive sleep apnoea (OSAS). Prescription rates of guideline-directed medical therapy (GDMT) increased significantly with BMI. The differences were most pronounced for mineralocorticoid receptor antagonists (MRAs) and diuretics. Patients with obesity more often received the guideline-recommended target dose. In multivariable logistic regression, obesity was significantly associated with a higher likelihood of receiving ≥100% of the guideline-recommended target dose of beta-blockers (OR 1.34, 95% CI 1.10-1.62), renin-angiotensin system (RAS)-inhibitors (OR 1.34, 95% CI 1.15-1.57) and MRAs (OR 1.40, 95% CI 1.04-1.87). CONCLUSIONS: Guideline-recommended HF drugs are more frequently prescribed and at a higher dose in patients with obesity as compared to HF patients without obesity.


Asunto(s)
Insuficiencia Cardíaca , Función Ventricular Izquierda , Humanos , Volumen Sistólico , Resultado del Tratamiento , Insuficiencia Cardíaca/tratamiento farmacológico , Insuficiencia Cardíaca/epidemiología , Antagonistas Adrenérgicos beta/uso terapéutico , Antagonistas de Receptores de Mineralocorticoides/uso terapéutico , Obesidad/complicaciones , Obesidad/epidemiología , Obesidad/tratamiento farmacológico , Antagonistas de Receptores de Angiotensina/uso terapéutico
8.
ESC Heart Fail ; 10(2): 884-894, 2023 04.
Artículo en Inglés | MEDLINE | ID: mdl-36460627

RESUMEN

AIMS: Use of left ventricular assist devices (LVADs) in older patients has increased, and assessing outcomes in older LVAD recipients is important. Therefore, this study aimed to investigate associations between age and outcomes after continuous-flow LVAD (cf-LVAD) implantation. METHODS AND RESULTS: Cf-LVAD patients from the multicentre European PCHF-VAD registry were included and categorized into those <50, 50-64, and ≥65 years old. The primary endpoint was all-cause mortality. Among secondary outcomes were heart failure (HF) hospitalizations, right ventricular (RV) failure, haemocompatibility score, bleeding events, non-fatal thromboembolic events, and device-related infections. Of 562 patients, 184 (32.7%) were <50, 305 (54.3%) were aged 50-64, whereas 73 (13.0%) were ≥65 years old. Median follow-up was 1.1 years. Patients in the oldest age group were significantly more often designated as destination therapy (DT) candidates (61%). A 10 year increase in age was associated with a significantly higher risk of mortality (hazard ratio [HR] 1.34, 95% confidence interval [CI] [1.15-1.57]), intracranial bleeding (HR 1.49, 95% CI [1.10-2.02]), and non-intracranial bleeding (HR 1.30, 95% CI [1.09-1.56]), which was confirmed by a higher mean haemocompatibility score (1.37 vs. 0.77, oldest vs. youngest groups, respectively, P = 0.033). Older patients suffered from less device-related infections requiring systemic antibiotics. No age-related differences were observed in HF-related hospitalizations, ventricular arrhythmias, pump thrombosis, non-fatal thromboembolic events, or RV failure. CONCLUSIONS: In the PCHF-VAD registry, higher age was associated with increased risk of mortality, and especially with increased risk of major bleeding, which is particularly relevant for the DT population. The risks of HF hospitalizations, pump thrombosis, ventricular arrhythmia, or RV failure were comparable. Strikingly, older patients had less device-related infections.


Asunto(s)
Insuficiencia Cardíaca , Corazón Auxiliar , Trombosis , Humanos , Anciano , Corazón Auxiliar/efectos adversos , Resultado del Tratamiento , Insuficiencia Cardíaca/epidemiología , Insuficiencia Cardíaca/terapia , Arritmias Cardíacas , Sistema de Registros , Trombosis/etiología
9.
ESC Heart Fail ; 10(2): 1054-1065, 2023 04.
Artículo en Inglés | MEDLINE | ID: mdl-36547014

RESUMEN

AIMS: Data on sex and left ventricular assist device (LVAD) utilization and outcomes have been conflicting and mostly confined to US studies incorporating older devices. This study aimed to investigate sex-related differences in LVAD utilization and outcomes in a contemporary European LVAD cohort. METHODS AND RESULTS: This analysis is part of the multicentre PCHF-VAD registry studying continuous-flow LVAD patients. The primary outcome was all-cause mortality. Secondary outcomes included ventricular arrhythmias, right ventricular failure, bleeding, thromboembolism, and the haemocompatibility score. Multivariable Cox regression models were used to assess associations between sex and outcomes. Overall, 457 men (81%) and 105 women (19%) were analysed. At LVAD implant, women were more often in Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) profile 1 or 2 (55% vs. 41%, P = 0.009) and more often required temporary mechanical circulatory support (39% vs. 23%, P = 0.001). Mean age was comparable (52.1 vs. 53.4 years, P = 0.33), and median follow-up duration was 344 [range 147-823] days for women and 435 [range 190-816] days for men (P = 0.40). No significant sex-related differences were found in all-cause mortality (hazard ratio [HR] 0.79 for female vs. male sex, 95% confidence interval [CI] [0.50-1.27]). Female LVAD patients had a lower risk of ventricular arrhythmias (HR 0.56, 95% CI [0.33-0.95]) but more often experienced right ventricular failure. No significant sex-related differences were found in other outcomes. CONCLUSIONS: In this contemporary European cohort of LVAD patients, far fewer women than men underwent LVAD implantation despite similar clinical outcomes. This is important as the proportion of female LVAD patients (19%) was lower than the proportion of females with advanced HF as reported in previous studies, suggesting underutilization. Also, female patients were remarkably more often in INTERMACS profile 1 or 2, suggesting later referral for LVAD therapy. Additional research in female patients is warranted.


Asunto(s)
Insuficiencia Cardíaca , Corazón Auxiliar , Humanos , Masculino , Femenino , Corazón Auxiliar/efectos adversos , Resultado del Tratamiento , Insuficiencia Cardíaca/epidemiología , Insuficiencia Cardíaca/terapia , Sistema de Registros
10.
ESC Heart Fail ; 9(1): 353-362, 2022 02.
Artículo en Inglés | MEDLINE | ID: mdl-34862765

RESUMEN

AIMS: Although diabetes mellitus (DM) is a common co-morbidity in chronic heart failure (HF) patients, European data on concurrent HF and DM treatment are lacking. Therefore, we have studied the HF treatment of patients with and without DM. Additionally, with the recent breakthrough of sodium-glucose cotransporter 2 (SGLT2) inhibitors in the field of HF, we studied the potential impact of this new drug in a large cohort of HF patients. METHODS AND RESULTS: A total of 7488 patients with chronic HF with a left ventricular ejection fraction <50% from 34 Dutch outpatient HF clinics between 2013 and 2016 were analysed on diabetic status and background HF therapy. Average age of the total population was 72.8 years (±11.7 years), and 64% of the patients were male. Diabetes was present in 29% of the patients (N = 2174). Diabetics had a worse renal function (mean estimated glomerular filtration rate 56 vs. 61 mL/min/1.73 m2 , P < 0.001). Renin-angiotensin system inhibitors were less often prescribed in diabetics compared with non-diabetics (79% vs. 82%, P = 0.001), while no significant differences regarding other guideline-recommended HF drugs were found. Target doses of beta-blockers (23% vs. 16%, P < 0.001), renin-angiotensin system inhibitors (47% vs. 43%, P = 0.009), and mineralocorticoid receptor antagonists (57% vs. 51%, P = 0.005) were more often prescribed in diabetics than non-diabetics. Based on the latest trials on SGLT2 inhibitors, 31-64% of all HF patients would fulfil the eligibility or enrichment criteria (with vs. without N-terminal prohormone BNP criterion). CONCLUSIONS: In this large real-world HF registry, a high prevalence of DM was observed and diabetics more often received guideline-recommended target doses. Based on current evidence, the majority of patients would fulfil the enrichment criteria of SGLT2 trials in HF and the impact of this new drug class will be large.


Asunto(s)
Diabetes Mellitus , Insuficiencia Cardíaca , Anciano , Insuficiencia Cardíaca/tratamiento farmacológico , Insuficiencia Cardíaca/epidemiología , Humanos , Masculino , Antagonistas de Receptores de Mineralocorticoides/farmacología , Antagonistas de Receptores de Mineralocorticoides/uso terapéutico , Volumen Sistólico , Función Ventricular Izquierda
11.
Future Cardiol ; 18(3): 173-183, 2022 03.
Artículo en Inglés | MEDLINE | ID: mdl-34697954

RESUMEN

Remote monitoring is becoming increasingly important for management of chronic heart failure patients. Recently, hemodynamic monitoring by measuring intracardiac filling pressures has been gaining attention. It is believed that hemodynamic congestion precedes clinical congestion by several weeks and that remote hemodynamic monitoring therefore enables clinicians to intervene in an early stage and prevent heart failure hospitalizations. The CardioMEMS HF system (Abbott, CA, USA) is a sensor capable of measuring pulmonary artery pressures as a surrogate of left ventricular filling pressures. Clinical evidence for CardioMEMS has been convincing in terms of efficacy and safety. This article provides detailed information on the CardioMEMS HF system and summarizes all available evidence of this promising technique.


Chronic heart failure, a disease in which the heart is unable to pump enough blood, affects millions of people worldwide and is associated with high rates of illness and death. The main problem of patients with chronic heart failure is the body's storage of excess fluid that leads to hospital admissions. These hospital admissions are expensive and bad in the long run. Doctors need to discover excess fluid as early as possible, preferably from a distance, so that patients can be kept out of the hospital. Unfortunately, methods for this are missing. The CardioMEMS™ HF system, a pressure sensor, was developed to watch for changes in a patient's fluid state from a distance. This article gives thorough information about the CardioMEMS HF system.


Asunto(s)
Insuficiencia Cardíaca , Monitorización Hemodinámica , Enfermedad Crónica , Insuficiencia Cardíaca/terapia , Hemodinámica , Humanos , Arteria Pulmonar
12.
ASAIO J ; 68(7): 899-906, 2022 07 01.
Artículo en Inglés | MEDLINE | ID: mdl-34643575

RESUMEN

Iron deficiency (ID) is a common comorbidity in heart failure (HF). In these patients, intravenous iron administration can improve clinical outcomes and quality of life (QoL). However, data on ID are lacking in patients who have transitioned toward left ventricular assist device (LVAD) or heart transplantation (HTx). All patients who underwent LVAD (n = 84) surgery or HTx (n = 67) at our center between 2012 and 2019, aged ≥18 years with a follow-up of ≥3 months, were included. Retrospectively, the prevalence of ID up to 1 year preoperatively, and up to February 2020 postoperatively, as well as all iron administrations were assessed during this period. Iron status was assessed in 61% and 51% of the LVAD and HTx patients preoperatively, and 81% and 84%, respectively, postoperatively. Of these patients, 53% and 71% of the LVAD and HTx patients preoperatively were diagnosed with ID preoperatively, and 71% and 77%, respectively, postoperatively. ID was more frequently diagnosed >3 months postoperatively. Sixty-three percent of the LVAD (mostly intravenous) and 63% of the HTx patients (mostly oral) received iron administration. ID is highly prevalent pre- and post-LVAD and HTx. It is plausible that substitution can have similar QoL gains as in regular HF patients.


Asunto(s)
Insuficiencia Cardíaca , Trasplante de Corazón , Corazón Auxiliar , Deficiencias de Hierro , Adolescente , Adulto , Insuficiencia Cardíaca/complicaciones , Insuficiencia Cardíaca/diagnóstico , Insuficiencia Cardíaca/cirugía , Trasplante de Corazón/efectos adversos , Corazón Auxiliar/efectos adversos , Humanos , Hierro/uso terapéutico , Prevalencia , Calidad de Vida , Estudios Retrospectivos , Resultado del Tratamiento
13.
Eur Heart J Case Rep ; 5(4): ytab112, 2021 Apr.
Artículo en Inglés | MEDLINE | ID: mdl-34268473

RESUMEN

BACKGROUND: Pulmonary hypertension (PH) is most commonly caused by left-sided heart disease and may negatively affect the long-term prognosis and quality of life of patients with chronic heart failure (CHF). CardioMEMS (Micro-Electro-Mechanical-System) allows physicians to monitor pulmonary artery (PA) pressures remotely and optimize heart failure treatment based on haemodynamic parameters, which provides further insight into the effect of valvular interventions. CASE SUMMARY: We present a case of a 61-year-old male patient with an ischaemic cardiomyopathy, poor LV function, moderate to severe mitral regurgitation, and severe aortic valve regurgitation in refractory heart failure. Right heart catheterization and CardioMEMS monitoring revealed severe pulmonary hypertension with mean PA pressures of 55 mmHg and a mean pulmonary capillary wedge pressure of 21 mmHg despite up titration of heart failure medication and sildenafil. Pulmonary and systemic causes of pulmonary hypertension were excluded. After heart team consensus, the patient underwent transcatheter aortic valve implantation (TAVI) which resulted in normalization of PA pressures and a significant improvement of functional performance. DISCUSSION: To the best of our knowledge, this is the first case report describing the direct effects of TAVI on continuous PA pressures in a patient with poor LV function and severe aortic regurgitation. Elective TAVI appeared to be safe and very effective in reverting severe pulmonary hypertension. Most strikingly, drug interventions could not affect the elevated pulmonary pressures, but TAVI corrected the aortic valve insufficiency with normalization of left-sided pulmonary hypertension.

14.
Sensors (Basel) ; 21(11)2021 May 28.
Artículo en Inglés | MEDLINE | ID: mdl-34071624

RESUMEN

The management of heart failure remains challenging despite evidence-based medical and pharmacological advances, especially in the ambulatory setting. There is an urgent need to develop strategies to reduce hospitalizations and readmission rates due to heart failure. Frequent monitoring of high-risk patients is imperative, and with the development of wireless and remote technology, frequent monitoring is now possible via remote monitoring. Nowadays, remote management of patients with cardiac implantable electronic devices is being increasingly adopted and integrated into clinical practice. Several clinical trials studied the impact of remote monitoring on clinical outcomes in patients with implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization defibrillators (CRT-Ds). This point of view will focus on the remote monitoring of ICDs and CRT-Ds in patients with heart failure and discusses whether remote monitoring can be used as a potential instrument for the early identification of patients at risk of worsening heart failure.


Asunto(s)
Terapia de Resincronización Cardíaca , Desfibriladores Implantables , Insuficiencia Cardíaca , Insuficiencia Cardíaca/diagnóstico , Insuficiencia Cardíaca/terapia , Humanos
15.
J Card Surg ; 36(9): 3271-3280, 2021 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-34159641

RESUMEN

BACKGROUND: There is a clinical need for additional remote tools to improve left ventricular assist device (LVAD) patient management. The aim of this pilot concept study was to assess the safety and feasibility of optimizing patient management with add-on remote hemodynamic monitoring using the CardioMEMS in LVAD patients during different treatment stages. METHODS: Ten consecutive patients accepted and clinically ready for (semi-) elective HeartMate 3 LVAD surgery were included. All patients received a CardioMEMS to optimize filling pressure before surgery. Patients were categorized into those with normal mean pulmonary artery pressure (mPAP) (≤25 mmHg, n = 4) or elevated mPAP (>25 mmHg, n = 6), and compared to a historical cohort (n = 20). Endpoints were CardioMEMS device safety and a combined endpoint of all-cause mortality, acute kidney injury, renal replacement therapy and/or right ventricular failure at 1-year follow-up. Additionally, we investigated hospital-free survival and improvement in quality of life (QoL) and exercise tolerance. RESULTS: No safety issues or signal interferences were observed. The combined endpoint occurred in 60% of historical controls, 0% in normal and 83% in elevated mPAP group. Post-discharge, the hospital-free survival was significantly better, and the QoL improved more in the normal compared to the elevated mPAP group. CONCLUSION: Remote hemodynamic monitoring in LVAD patients is safe and feasible with the CardioMEMS, which could be used to identify patients at elevated risk of complications as well as optimize patient management remotely during the out-patient phase with less frequent hospitalizations. Larger pivotal studies are warranted to test the hypothesis generated from this concept study.


Asunto(s)
Insuficiencia Cardíaca , Corazón Auxiliar , Monitorización Hemodinámica , Cuidados Posteriores , Estudios de Factibilidad , Insuficiencia Cardíaca/terapia , Hemodinámica , Humanos , Alta del Paciente , Arteria Pulmonar , Calidad de Vida
16.
Sensors (Basel) ; 21(7)2021 Mar 27.
Artículo en Inglés | MEDLINE | ID: mdl-33801573

RESUMEN

The CardioMEMS pulmonary artery (PA) monitoring system placed in the left lower lobe pulmonary artery is capable of measuring pulmonary artery pressure remotely as a surrogate of intracardiac filling pressures and volume status. The technique is safe and reliable. By using remote PA monitoring for proactive medical interventions, there is a growing body of clinical evidence for a substantial, robust reduction in HF hospitalizations in various populations (clinical trial setting, post-marketing studies and real-world experiences). This review summarizes the clinical evidence, outlines future perspectives, and aims for remote patient care in heart failure using CardioMEMS.


Asunto(s)
Insuficiencia Cardíaca , Monitorización Hemodinámica , Enfermedad Crónica , Insuficiencia Cardíaca/diagnóstico , Insuficiencia Cardíaca/terapia , Humanos , Arteria Pulmonar
17.
Sensors (Basel) ; 21(6)2021 Mar 12.
Artículo en Inglés | MEDLINE | ID: mdl-33809205

RESUMEN

The large and growing burden of chronic heart failure (CHF) on healthcare systems and economies is mainly caused by a high hospital admission rate for acute decompensated heart failure (HF). Several remote monitoring techniques have been developed for early detection of worsening disease, potentially limiting the number of hospitalizations. Over the last years, the scope has been shifting towards the relatively novel invasive sensors capable of measuring intracardiac filling pressures, because it is believed that hemodynamic congestion precedes clinical congestion. Monitoring intracardiac pressures may therefore enable clinicians to intervene and avert hospitalizations in a pre-symptomatic phase. Several techniques have been discussed in this review, and thus far, remote monitoring of pulmonary artery pressures (PAP) by the CardioMEMS (CardioMicroelectromechanical system) HF System is the only technique with proven safety as well as efficacy with regard to the prevention of HF-related hospital admissions. Efforts are currently aimed to further develop existing techniques and new sensors capable of measuring left atrial pressures (LAP). With the growing body of evidence and need for remote care, it is expected that remote monitoring by invasive sensors will play a larger role in HF care in the near future.


Asunto(s)
Insuficiencia Cardíaca , Enfermedad Crónica , Insuficiencia Cardíaca/diagnóstico , Humanos
18.
Sensors (Basel) ; 21(3)2021 Jan 28.
Artículo en Inglés | MEDLINE | ID: mdl-33525556

RESUMEN

Heart failure (HF) is a major health care issue, and the incidence of HF is only expected to grow further. Due to the frequent hospitalizations, HF places a major burden on the available hospital and healthcare resources. In the future, HF care should not only be organized solely at the clinical ward and outpatient clinics, but remote monitoring strategies are urgently needed to guide, monitor, and treat chronic HF patients remotely from their homes as well. The intuitiveness and relatively low costs of non-invasive remote monitoring tools make them an appealing and emerging concept for developing new medical apps and devices. The recent COVID-19 pandemic and the associated transition of patient care outside the hospital will boost the development of remote monitoring tools, and many strategies will be reinvented with modern tools. However, it is important to look carefully at the inconsistencies that have been reported in non-invasive remote monitoring effectiveness. With this review, we provide an up-to-date overview of the available evidence on non-invasive remote monitoring in chronic HF patients and provide future perspectives that may significantly benefit the broader group of HF patients.


Asunto(s)
Continuidad de la Atención al Paciente/tendencias , Insuficiencia Cardíaca/terapia , Monitoreo Fisiológico/métodos , Telemedicina/tendencias , COVID-19 , Insuficiencia Cardíaca/diagnóstico , Humanos , Pandemias , SARS-CoV-2 , Telemetría , Teleenfermería
19.
Future Cardiol ; 17(5): 885-898, 2021 08.
Artículo en Inglés | MEDLINE | ID: mdl-33410726

RESUMEN

Aim: We aimed to assess the safety and feasibility of using CardioMEMS monitoring in patients before and after left ventricular assist device (LVAD) surgery. Patients & methods: Ten patients accepted for elective LVAD surgery were included, received a CardioMEMS at baseline and were categorized based on mean pulmonary artery pressure (mPAP) ≤25 mmHg (n = 4) or mPAP >25 mmHg [n = 6]) before LVAD surgery. Results: The combined end point of all-cause mortality, acute kidney injury and/or renal replacement therapy, and right ventricular failure occurred more often in patients with an mPAP >25 mmHg (83 vs 0%, p = 0.017). Conclusion: This pilot study demonstrates that combining CardioMEMS monitoring with LVAD therapy is safe and generates the hypothesis that patients with an mPAP >25 mmHg before LVAD surgery identify a very high-risk group for adverse clinical outcomes.


Asunto(s)
Insuficiencia Cardíaca , Corazón Auxiliar , Insuficiencia Cardíaca/terapia , Hemodinámica , Humanos , Proyectos Piloto , Estudios Retrospectivos , Resultado del Tratamiento
20.
Catheter Cardiovasc Interv ; 96(3): E204-E212, 2020 09 01.
Artículo en Inglés | MEDLINE | ID: mdl-31789481

RESUMEN

OBJECTIVES: The aim of this study was to evaluate the very long-term clinical outcome after radioactive stent (RS) implantation and intracoronary ß radiation brachytherapy (IRBT). BACKGROUND: Radioactive stents (RS) and intracoronary ß radiation brachytherapy (IRBT) were introduced to prevent restenosis after percutaneous coronary intervention (PCI). Both techniques were associated with a higher incidence of major adverse cardiac events (MACE) in the short and intermediate-term follow up as compared to conventional PCI. METHODS: One hundred and thirty-three patients received radioactive stents (32 P) and 301 patients were treated with IRBT adjunctive to PCI. These groups were propensity matched to respectively 266 and 602 control patients who were treated with routine PCI during the same inclusion period. Endpoints were all-cause mortality and MACE, defined as all-cause death, any myocardial infarction or any revascularization. RESULTS: Median follow-up duration was 17 years. All-cause mortality rates were similar in all groups. Adjusted hazard ratios for MACE and mortality in the RS cohort were 1.55 (95% CI 1.20-2.00) and 0.92 (95% CI 0.63-1.34), respectively. Adjusted hazard ratios for MACE and all-cause mortality in the IRBT cohort were 1.41 (95% CI 1.18-1.67) and 0.95 (95% CI 0.74-1.21), respectively. The difference in MACE rates was predominantly driven by coronary revascularizations in both groups, with a higher MI rate in the IRBT group as well. CONCLUSIONS: Coronary radiation therapy was associated with early increased MACE rates, but the difference in MACE rates decreased beyond 2 years, resulting in a comparable long-term clinical outcome. Importantly, no excess in mortality was observed.


Asunto(s)
Braquiterapia , Enfermedad de la Arteria Coronaria/terapia , Reestenosis Coronaria/prevención & control , Intervención Coronaria Percutánea/instrumentación , Stents , Anciano , Braquiterapia/efectos adversos , Braquiterapia/mortalidad , Estudios de Casos y Controles , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/mortalidad , Reestenosis Coronaria/diagnóstico por imagen , Reestenosis Coronaria/etiología , Reestenosis Coronaria/mortalidad , Femenino , Humanos , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Países Bajos , Intervención Coronaria Percutánea/efectos adversos , Intervención Coronaria Percutánea/mortalidad , Medición de Riesgo , Factores de Riesgo , Factores de Tiempo , Resultado del Tratamiento
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