Pulmonary artery pressure monitoring in chronic heart failure: effects across clinically relevant subgroups in the MONITOR-HF trial.

BACKGROUND AND AIMS: In patients with chronic heart failure (HF), the MONITOR-HF trial demonstrated the efficacy of pulmonary artery (PA)-guided HF therapy over standard of care in improving quality of life and reducing HF hospitalizations and mean PA pressure. This study aimed to evaluate the consistency of these benefits in relation to clinically relevant subgroups. METHODS: The effect of PA-guided HF therapy was evaluated in the MONITOR-HF trial among predefined subgroups based on age, sex, atrial fibrillation, diabetes mellitus, left ventricular ejection fraction, HF aetiology, cardiac resynchronisation therapy, and implantable cardioverter defibrillator. Outcome measures were based upon significance in the main trial and included quality of life, clinical, and PA pressure endpoints, and were assessed for each subgroup. Differential effects in relation to the subgroups were assessed with interaction terms. Both unadjusted and multiple testing adjusted interaction terms were presented. RESULTS: The effects of PA monitoring on quality of life, clinical events, and PA pressure were consistent in the predefined subgroups, without any clinically relevant heterogeneity within or across all endpoint categories (all adjusted interaction P-values were nonsignificant). In the unadjusted analysis of the primary endpoint quality-of-life change, weak trends towards a less pronounced effect in older patients (Pinteraction = 0.03; adjusted Pinteraction = 0.33) and diabetics (Pinteraction = 0.01; adjusted Pinteraction = 0.06) were observed. However, these interaction effects did not persist after adjusting for multiple testing. CONCLUSIONS: This subgroup analysis confirmed the consistent benefits of PA-guided HF therapy observed in the MONITOR-HF trial across clinically relevant subgroups, highlighting its efficacy in improving quality of life, clinical, and PA pressure endpoints in chronic HF patients.

Emergency Heart failure Mortality Risk Grade may help to reduce heart failure admissions.

INTRODUCTION: Hospital admissions for heart failure (HF) are frequent and pose a heavy burden on health care resources. Currently, the decision to hospitalise is based on clinical judgement rather than on prognostic risk stratification. The Emergency Heart failure Mortality Risk Grade (EHMRG) was recently developed to identify high-risk HF patients in the emergency department (ED). OBJECTIVE: To assess the ability of the EHMRG to predict 30-day mortality in Dutch HF patients visiting the ED and to evaluate whether the EHMRG could help to reduce the number of hospital admissions for decompensated HF. METHODS: Patients visiting the ED for decompensated HF were included. The decision to hospitalise or discharge was based on clinical judgement. The EHMRG was calculated retrospectively. Based on their EHMRG, patients were stratified as very low risk, low risk, intermediate risk, high risk and very high risk. RESULTS: In 227 patients (age 73 ± 12 years, 69% male) 30-day mortality was 11%. Mortality differed significantly among the EHMRG risk groups at 7­day (p = 0.012) and 30-day follow-up (p < 0.01). Based on clinical judgement, 76% of patients were hospitalised. If decision-making had been based on EHMRG, the hospitalisation rate could have been reduced to 66% (p < 0.01), particularly by reducing hospitalisations in patients at low risk of death. Mortality in discharged patients, whether the decision was based on EHMRG or clinical judgement, was 0%. CONCLUSION: The EHMRG accurately differentiates between high- and low-risk decompensated HF patients visiting the ED, making it a promising tool to safely reduce the number of HF admissions.

No substantial excess all-cause mortality among cardiac implantable electronic device patients during the first COVID­19 lockdown in the Leiden area.

In the Netherlands, the coronavirus disease 2019 (COVID­19) pandemic has resulted in excess mortality nationwide. Chronic heart disease patients are at risk for a complicated COVID­19 course. The current study investigates all-cause mortality among cardiac implantable electronic device (CIED) patients during the first peak of the pandemic and compares the data to the statistics for the corresponding period in the two previous years. Data of adult CIED patients undergoing follow-up at the Leiden University Medical Centre were analysed. All-cause mortality between 1 March and 31 May 2020 was evaluated and compared to the data for the same period in 2019 and 2018. At the beginning of the first peak of the pandemic, 3,171 CIED patients (median age 70 years; 68% male; 41% ischaemic aetiology) were alive. Baseline characteristics of the 2019 (n = 3,216) and 2018 (n = 3,169) cohorts were comparable. All-cause mortality during the peak of the pandemic was 1.4% compared to 1.6% and 1.4% in the same period in 2019 and 2018, respectively (p = 0.84). During the first peak of the COVID­19 pandemic, there was no substantial excess mortality among CIED patients in the Leiden area, despite the fact that this is group at high risk for a complicated course of a COVID­19 infection. Strict adherence to the preventive measures may have prevented substantial excess mortality in these vulnerable patients.

Emergency medical services evaluations for chest pain during first COVID-19 lockdown in Hollands-Midden, the Netherlands.

OBJECTIVE: To assess whether the COVID-19 lockdown in 2020 had negative indirect health effects, as people seem to have been reluctant to seek medical care. METHODS: All emergency medical services (EMS) transports for chest pain or out-of-hospital cardiac arrest (OHCA) in the Dutch region Hollands-Midden (population served > 800,000) were evaluated during the initial 6 weeks of the COVID-19 lockdown and during the same time period in 2019. The primary endpoint was the number of evaluated chest pain patients in both cohorts. In addition, the number of EMS evaluations of ST-elevation myocardial infarction (STEMI) and OHCA were assessed. RESULTS: During the COVID-19 lockdown period, the EMS evaluated 927 chest pain patients (49% male, age 62 ± 17 years) compared with 1041 patients (51% male, 63 ± 17 years) in the same period in 2019, which corresponded with a significant relative risk (RR) reduction of 0.88 (95% confidence interval (CI) 0.81-0.96). Similarly, there was a significant reduction in the number of STEMI patients (RR 0.52, 95% CI 0.32-0.85), the incidence of OHCA remained unchanged (RR 1.23, 95% CI 0.83-1.83). CONCLUSION: During the first COVID-19 lockdown, there was a significant reduction in the number of patients with chest pain or STEMI evaluated by the EMS, while the incidence of OHCA remained similar. Although the reason for the decrease in chest pain and STEMI consultations is not entirely clear, more attention should be paid to the importance of contacting the EMS in case of suspected cardiac symptoms in possible future lockdowns.

Non-ST-elevation myocardial infarction in the Netherlands: room for improvement!

AIM: To analyse non-ST-elevation myocardial infarction (NSTEMI) care in the Netherlands and to identify modifiable factors to improve NSTEMI healthcare. METHODS: This retrospective cohort study analysed hospital and pharmacy claims data of all NSTEMI patients in the Netherlands in 2015. The effect of percutaneous coronary intervention (PCI) during hospitalisation on 1­year mortality was investigated in the subcohort alive 4 days after NSTEMI. The effect of medical treatment on 1­year mortality was assessed in the subcohort alive 30 days after NSTEMI. The effect of age, gender and co-morbidities was evaluated. PCI during hospitalisation was defined as PCI within 72 h after NSTEMI and optimal medical treatment was defined as the combined use of an aspirin species, P2Y12 inhibitor, statin, beta-blocker and angiotensin converting enzyme inhibitor/angiotensin II receptor blocker, started within 30 days after NSTEMI. RESULTS: Data from 17,997 NSTEMI patients (age 69.6 (SD = 12.8) years, 64% male) were analysed. Of the patients alive 4 days after NSTEMI, 43% had a PCI during hospitalisation and 1­year mortality was 10%. In the subcohort alive 30 days after NSTEMI, 47% of patients were receiving optimal medical treatment at 30 days and 1­year mortality was 7%. PCI during hospitalisation (odds ratio (OR) 0.42; 95% confidence interval (CI) 0.37-0.48) and optimal medical treatment (OR 0.59; 95% CI 0.51-0.67) were associated with a lower 1­year mortality. CONCLUSION: In Dutch NSTEMI patients, use of PCI during hospitalisation and prescription of optimal medical treatment are modest. As both are independently associated with a lower 1­year mortality, this study provides direction on how to improve the quality of NSTEMI healthcare in the Netherlands.

A randomised comparison of the effect of haemodynamic monitoring with CardioMEMS in addition to standard care on quality of life and hospitalisations in patients with chronic heart failure : Design and rationale of the MONITOR HF multicentre randomised clinical trial.

BACKGROUND: Assessing haemodynamic congestion based on filling pressures instead of clinical congestion can be a way to further improve quality of life (QoL) and clinical outcome by intervening before symptoms or weight gain occur in heart failure (HF) patients. The clinical efficacy of remote monitoring of pulmonary artery (PA) pressures (CardioMEMS; Abbott Inc., Atlanta, GA, USA) has been demonstrated in the USA. Currently, the PA sensor is not reimbursed in the European Union as its benefit when applied in addition to standard HF care is unknown in Western European countries, including the Netherlands. AIMS: To demonstrate the efficacy and cost-effectiveness of haemodynamic PA monitoring in addition to contemporary standard HF care in a high-quality Western European health care system. METHODS: The current study is a prospective, multi-centre, randomised clinical trial in 340 patients with chronic HF (New York Heart Association functional class III) randomised to HF care including remote monitoring with the CardioMEMS PA sensor or standard HF care alone. Eligible patients have at least one hospitalisation for HF in 12 months before enrolment and will be randomised in a 1:1 ratio. Minimum follow-up will be 1 year. The primary endpoint is the change in QoL as measured by the Kansas City Cardiomyopathy Questionnaire (KCCQ). Secondary endpoints are the number of HF hospital admissions and changes in health status assessed by EQ-5D-5L questionnaire including health care utilisation and formal cost-effectiveness analysis. CONCLUSION: The MONITOR HF trial will evaluate the efficacy and cost-effectiveness of haemodynamic monitoring by CardioMEMS in addition to standard HF care in patients with chronic HF. Clinical Trial Registration number NTR7672.

Ventricular assist device implantation in patients with a failing systemic right ventricle: a call to expand current practice.

Ventricular assist device (VAD) implantation is an established treatment modality for patients with end-stage heart failure, and improves symptoms and survival. In the Netherlands, it is not yet routinely considered in patients with congenital heart disease and failing systemic right ventricle (SRV). Recently, a VAD was implanted in 2 SRV patients, one who underwent a Mustard procedure during infancy for transposition of the great arteries (male, 47 years old) and one with a congenitally corrected transposition of the great arteries (male, 54 years old). The first patient is doing well >1 year after implantation; the second patient will be discharged home soon. These examples and other reports demonstrate the feasibility of adopting VAD implantation into routine care for SRV failure. In conclusion, patients with SRV failure may be suitable candidates for VAD implantation: they are relatively young, usually have a preserved subpulmonary left ventricular function, and their specific anatomical and physiological characteristics often make them unsuitable for cardiac transplantation. Therefore it is important to recognise the possibility of VAD implantation early in the process of SRV failure, and to timely refer these patients to a heart failure clinic with experience in VAD implantation in this group of patients for optimisation, screening, and implantation.

Prognostic Importance of Increased Right Ventricular Afterload in Orthotopic Liver Transplantation Recipients With Endstage Cirrhosis.

BACKGROUND: Severely increased right ventricular (RV) afterload is considered a contra-indication for orthotopic liver transplantation (OLT). This study assesses the effects of mildly increased RV afterload on long-term outcome after OLT in relation to RV function. METHODS: 139 OLT recipients (53±12years, 76% male) were included. Preoperative RV afterload was assessed invasively or, if not available, echocardiographically and categorised as normal, high-normal (mean pulmonary artery pressure [PAP] 20-25mmHg or echocardiographic systolic PAP 35-40mmHg) or mildly elevated (mean PAP 25-35mmHg or systolic PAP 40-50mmHg). The association between level of RV afterload, echocardiographic RV function and postoperative outcome was assessed. RESULTS: Right ventricular afterload was high-normal in 17% and mildly elevated in 12% of patients. Patients with elevated RV afterload had higher echocardiographic RV dimensions and left ventricular filling pressures. RV functional parameters were within normal range and not associated with RV afterload. Increased RV afterload was associated with a higher incidence of postoperative haemodynamic complications (8%, 17%, and 29% for normal, high-normal and mildly elevated RV afterload, respectively, p=0.03) and worse survival (8-year survival 74%, 41% and 37% respectively, p=0.01). Preoperative RV function was not associated with outcome after OLT. CONCLUSIONS: Increased RV afterload was associated with increased haemodynamic complications and worse long-term survival in OLT recipients. Right ventricular function in patients with increased RV afterload was within normal range and not associated with postoperative outcome.

Left ventricular assist device for end-stage heart failure: results of the first LVAD destination program in the Netherlands.

PURPOSE: Mechanical circulatory support with a continuous-flow left ventricular assist device (LVAD) may be a valuable treatment in end-stage heart failure patients for an extended period of time. The purpose of this study was to evaluate the safety and efficacy of implantation of a continuous-flow LVAD in end-stage heart failure patients within the first destination program in the Netherlands. METHODS: A third-generation LVAD was implanted in 16 heart failure patients (age 61 ± 8; 81 % male; left ventricular ejection fraction 20 ± 6 %) as destination therapy. All patients were ineligible for heart transplant. At baseline, 3 and 6 months, New York Heart Association (NYHA) functional class, quality-of-life and exercise capacity were assessed. Clinical adverse events were registered. RESULTS: Survival at 30 days and 6 months was 88 and 75 %, respectively. In the postoperative phase, 6 (38 %) patients required continuous veno-venous haemofiltration for renal failure and 2 (13 %) patients required extracorporeal membrane oxygenation because of severe right ventricular failure. During follow-up, NYHA functional class and quality-of-life improved from 3.7 ± 0.1 to 2.3 ± 0.1 and 57 ± 5 to 23 ± 3 at 6 months (P < 0.001), respectively. The 6 min walking distance improved from 168 ± 42 m to 291 ± 29 m at 6 months (P = 0.001). CONCLUSION: Continuous-flow LVAD therapy is a promising treatment for patients with end-stage heart failure ineligible for heart transplant.

Effect of intramyocardial bone marrow cell injection on left ventricular dyssynchrony and global strain.

OBJECTIVE: To evaluate the effect of bone marrow cell injection on global strain and left ventricular (LV) dyssynchrony. METHODS: In 14 patients with severe postinfarction heart failure, 93 (14) x 10(6) autologous bone marrow cells were percutaneously injected in the infarction border zone. LV ejection fraction (LVEF), LV dyssynchrony and echocardiographic global strain were assessed at baseline and 3 months in patients and in a non-randomised control group of 10 patients with a history of infarction who developed heart failure and were treated medically. RESULTS: No periprocedural complications occurred during bone marrow cell injection. At 3 months mean (SD) LVEF increased from 23 (8)% to 27 (9)% (p = 0.02) and global strain improved from -7.7 (4.7)% to -8.5 (4.9)% (p = 0.04). In patients with > or =5% improvement in LVEF after bone marrow cell injection, global strain improved from -8.7 (4.6)% to -10.6 (4.5)% (p<0.01). Global strain remained unchanged in patients with <5% improvement in LVEF (-6.6 (4.9)% vs -6.4 (4.5)%, p = NS). The relation between the increase in LVEF and improvement in global strain was significant (r = 0.84, p<0.01). In patients with > or =5% improvement in LVEF, LV dyssynchrony decreased from 173 (64) ms to 116 (64) ms (p = 0.01). In patients with <5% improvement in LVEF, LV dyssynchrony remained unchanged (155 (67) ms vs 177 (81) ms, p = NS). The correlation between improvement in LVEF and reduction in LV dyssynchrony was good (r = -0.77, p<0.01). In the control group, LVEF, global strain and LV dyssynchrony did not improve. CONCLUSIONS: Bone marrow cell injection improves LVEF in patients with severe postinfarction heart failure. The improvement in LVEF was related to reduced LV dyssynchrony and increased global strain.

[Intramyocardial injection of autologous bone-marrow stem cells in a 74-year-old man with untreatable angina pectoris and demonstrated myocardial ischaemia]. / Intramyocardiale injectie van autologe stamcellen bij een 74-jarige man met onbehandelbare angina pectoris en bewezen myocardischemie.

For a 74-year-old man with angina pectoris and demonstrated myocardial ischaemia, optimal medical treatment was insufficient. He was ineligible for coronary revascularization. To improve myocardial perfusion, autologous bone-marrow stem cells were injected into the ischaemic myocardium. During the months following the injection, the frequency of angina attacks decreased and myocardial perfusion and cardiac function improved.