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.

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.

Telemonitoring with an implantable loop recorder in outpatient heart failure care : One year follow-up report from a prospective observational Dutch multicentre study.

INTRODUCTION: In the care of heart failure patients, telemonitoring is receiving growing attention. The main purpose of this study was to determine the effect of continuous telemonitoring with an implantable loop recorder (ILR, Reveal XT), a novel strategy in the management of stable heart failure patients without a cardiac implantable device. Furthermore, little is known about the incidence of subclinical arrhythmias in this specific group of patients. MATERIALS AND METHODS: Stable heart failure patients, New York Heart Association Class II and III, without recent hospitalisation or upcoming intervention, were included. After implantation of the ILR there was regular contact with the research nurse on a pre-specified basis. Clinic visits and telephonic interviews were alternated for a minimum of 1 year. Parallel visits to their treating physician continued according to standard care. The treating physician was blinded for the ILR findings, accept for pre-specified, significant arrhythmic events. RESULTS: Thirty patients were included and followed for a median duration of 12 months. In 13 patients, data from the loop recorder led to therapeutic changes. One patient received a pacemaker. Eight patients developed atrial fibrillation, all subclinical, with a mean burden of 65.8 ± 173.2 min/day. CONCLUSION: The use of an ILR could potentially impact patient management. Additional study is needed in different patient populations (e. g. higher risk groups) to assess if an ILR could also impact on endpoints such as heart failure hospitalisation.

General practitioner reported incidence of Lyme carditis in the Netherlands.

BACKGROUND: Between 1994 and 2009, incidence rates of general practitioner (GP) consultations for tick bites and erythema migrans, the most common early manifestation of Lyme borreliosis, have increased substantially in the Netherlands. The current article aims to estimate and validate the incidence of GP-reported Lyme carditis in the Netherlands. METHODS: We sent a questionnaire to all GPs in the Netherlands on clinical diagnoses of Lyme borreliosis in 2009 and 2010. To validate and adjust the obtained incidence rate, medical records of cases of Lyme carditis reported by GPs in this incidence survey were reviewed and categorised according to likelihood of the diagnosis of Lyme carditis. RESULTS: Lyme carditis occurred in 0.2 % of all patients with GP-reported Lyme borreliosis. The adjusted annual incidence was six GP-reported cases of Lyme carditis per 10 million inhabitants, i.e. approximately ten cases per year in 2009 and 2010. CONCLUSIONS: We report the first incidence estimate for Lyme carditis in the Netherlands, validated by a systematic review of the medical records. Although Lyme carditis is an uncommon manifestation of Lyme borreliosis, physicians need to be aware of this diagnosis, in particular in countries where the incidence of Lyme borreliosis has increased during the past decades.

Routine versus aggressive upstream rhythm control for prevention of early atrial fibrillation in heart failure: background, aims and design of the RACE 3 study.

BACKGROUND: Rhythm control for atrial fibrillation (AF) is cumbersome because of its progressive nature caused by structural remodelling. Upstream therapy refers to therapeutic interventions aiming to modify the atrial substrate, leading to prevention of AF. OBJECTIVE: The Routine versus Aggressive upstream rhythm Control for prevention of Early AF in heart failure (RACE 3) study hypothesises that aggressive upstream rhythm control increases persistence of sinus rhythm compared with conventional rhythm control in patients with early AF and mild-to-moderate early systolic or diastolic heart failure undergoing electrical cardioversion. DESIGN: RACE 3 is a prospective, randomised, open, multinational, multicenter trial. Upstream rhythm control consists of angiotensin converting enzyme inhibitors and/or angiotensin receptor blockers, mineralocorticoid receptor antagonists, statins, cardiac rehabilitation therapy, and intensive counselling on dietary restrictions, exercise maintenance, and drug adherence. Conventional rhythm control consists of routine rhythm control therapy without cardiac rehabilitation therapy and intensive counselling. In both arms, every effort is made to keep patients in the rhythm control strategy, and ion channel antiarrhythmic drugs or pulmonary vein ablation may be instituted if AF relapses. Total inclusion will be 250 patients. If upstream therapy proves to be effective in improving maintenance of sinus rhythm, it could become a new approach to rhythm control supporting conventional pharmacological and non-pharmacological rhythm control.

Electrical cardioversion during pregnancy: safe or not?

Two pregnant patients with a sustained symptomatic maternal supraventricular arrhythmia are presented. Both patients were treated with direct-current cardioversion. Electrical cardioversion during pregnancy is a rarely applied but highly effective procedure in the treatment of maternal cardiac arrhythmias and is assumed safe for both mother and child. However, once foetal viability is reached, monitoring of the foetal heart rate is advised and facilities for immediate caesarean section should be available.

Tako Tsubo cardiomyopathy, presenting with cardiogenic shock in a 24-year-old patient with anorexia nervosa.

Tako Tsubo cardiomyopathy is a serious condition that is caused by heart failure due to inordinate stress. We here present a case of a young woman with this disorder in association with anorexia nervosa. We postulate a pathophysiological relationship and discuss the management of Tako Tsubo cardiomyopathy.

Short-coupled variant of torsade de pointes.

A 36-year-old man with a history of primary sclerosing cholangitis and epilepsy was admitted to our hospital for cholangitis. During admission he was resuscitated because of ventricular fibrillation. ECGs showed multiple ventricular premature beats (VPBs) with a short coupling interval (240 ms), resulting in frequent torsade de pointes (TdP). In total, the patient had to be defibrillated 12 times. Short-coupled TdP is a rare variant of polymorphic ventricular tachycardia, with unknown aetiology. Verapamil seems to be the only drug able to suppress the arrhythmia. Verapamil, however, does not lower the risk of sudden death; therefore, an ICD implantation is advised. (Neth Heart J 2008;16:246-9.).

ICD-implantation guidelines versus clinical practice: a prospective study of out-of-hospital cardiac arrest survivors.

AIMS: The aim of this study was prospectively to compare clinical practice of implantable cardioverter defibrillator (ICD) use with current guidelines in out-of-hospital cardiac arrest (OHCA) survivors. METHODS AND RESULTS: From January 2000 till March 2002, 70 consecutive patients (pts) discharged from 15 hospitals after OHCA, with ventricular fibrillation (VF) as initial rhythm were included. Documentation of diagnosis, left ventricular function, ischaemia, electrophysiological studies (EPS), and decisions regarding ICD implantation were obtained from medical records. An expert committee compared these data with current guidelines. According to these guidelines 18 pts (26%) had an ICD indication and received an ICD while 37 pts (53%) had no indication and did not receive an ICD. In 13 pts without acute myocardial infarction insufficient diagnostic procedures were performed to permit a decision on ICD indication, hence no ICD was implanted. Two pts had an ICD indication but did not receive an ICD. During the follow-up with duration of 25 months (range 12-38 months), two sudden deaths occurred in the group of pts without an ICD. Of the pts with an ICD, 4 pts (22%) were reported to have received one or more shocks for VT/VF. CONCLUSION: In at least 21% of OHCA survivors, insufficient diagnostic procedures concerning the indication for ICD implantation were performed or no ICD was implanted when indicated, despite clear guidelines. In particular, there was no proof of ischaemia prior to revascularization and no confirmation of the absence of ischaemia and EPS thereafter. Clinicians should be guided better in evaluating pts after OHCA concerning the indication for ICD implantation, especially when a transient of reversible condition was present or when treatment was sufficiently established safely to refrain from ICD implantation.