Hospital utilisation and the costs associated with complications of ICD implantation in a contemporary primary prevention cohort.

INTRODUCTION: Implantation of an implantable cardioverter defibrillator (ICD) is standard care for primary prevention of sudden cardiac death. However, ICD-related complications are increasing as the population of ICD recipients grows. METHODS: ICD-related complications in a national DO-IT Registry cohort of 1442 primary prevention ICD patients were assessed in terms of additional use of hospital care resources and costs. RESULTS: During a median follow-up of 28.7 months (IQR 25.2-33.7) one or more complications occurred in 13.5% of patients. A complication resulted in a surgical intervention in 53% of cases and required on average 3.65 additional hospital days. The additional hospital costs were €6,876 per complication or €8,110 per patient, to which clinical re-interventions and additional hospital days contributed most. Per category of complications, infections required most hospital utilisation and were most expensive at an average of €22,892. The mean costs were €5,800 for lead-related complications, €2,291 for pocket-related complications and €5,619 for complications due to other causes. We estimate that the total yearly incidence-based costs in the Netherlands for hospital management of ICD-related complications following ICD implantation for primary prevention are €2.7 million. CONCLUSION: Complications following ICD implantation are related to a substantial additional need for hospital resources. When performing cost-effectiveness analyses of ICD implantation, including the costs associated with complications, one should be aware that real-world complication rates may deviate from trial data. Considering the economic implications, strategies to reduce the incidence of complications are encouraged.

Implantable defibrillator therapy and mortality in patients with non-ischaemic dilated cardiomyopathy : An updated meta-analysis and effect on Dutch clinical practice by the Task Force of the Dutch Society of Cardiology.

BACKGROUND: Primary prophylactic implantable cardioverter-defibrillators (ICDs) in patients with non-ischaemic cardiomyopathy (NICMP) remains controversial. This study sought to assess the benefit of ICD therapy with or without cardiac resynchronisation therapy (CRT) in patients with NICMP. In addition, data were compared with real-world clinical data to perform a risk/benefit analysis. METHODS: Relevant randomised clinical trials (RCTs) published in meta-analyses since DANISH, and in PubMed, EMBASE and Cochrane databases from 2016 to 2020 were identified. The benefit of ICD therapy stratified by CRT use was assessed using random effects meta-analysis techniques. RESULTS: Six RCTs were included in the meta-analysis. Among patients without CRT, ICD use was associated with a 24% reduction in mortality (hazard ratio [HR]: 0.76; 95% confidence interval [CI]: 0.62-0.93; P = 0.008). In contrast, among patients with CRT, a CRT-defibrillator was not associated with reduced mortality (HR: 0.74, 95% CI 0.47-1.16; P = 0.19). For ICD therapy without CRT, absolute risk reduction at 3­years follow-up was 3.7% yielding a number needed to treat of 27. CONCLUSION: ICD use significantly improved survival among patients with NICMP who are not eligible for CRT. Considering CRT, the addition of defibrillator therapy was not significantly associated with mortality benefit compared with CRT pacemaker.

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.

Effective contact and outcome after pulmonary vein isolation in novel circular multi-electrode atrial fibrillation ablation.

INTRODUCTION: Pulmonary vein (PV) reconnection is frequently the cause of recurrence of atrial fibrillation (AF) after ablation. The second-generation gold multi-electrode ablation (Gold-MEA) catheter has a new design possibly resulting in improved lesion formation compared with its predecessor. We aimed to determine the association between effective radiofrequency applications with the Gold-MEA catheter and outcome after AF ablation. METHODS: 50 consecutive patients with paroxysmal AF underwent Gold-MEA (PVAC GOLDTM, Medtronic Inc.) ablation. The Gold-MEA catheter was navigated to the PV ostium by fluoroscopy. Duty-cycled radiofrequency ablations were performed at all PV ostia. Lesions were considered transmural when electrode temperature was >50 °C and power >3 W for >30 seconds. After the ablation procedure, patients visited the outpatient clinic at 3­month intervals including 24-hour Holter ECGs. RESULTS: Mean age was 56 years. All PVs were acutely isolated with the Gold-MEA catheter. Procedure time was 111 ± 22 minutes, ablation time was 24 ± 6.7 minutes and fluoroscopy time was 20 ± 8.1 minutes. No procedure-related complications were observed. One year after ablation, 60 % of patients were still free of arrhythmia recurrences after a single PV isolation attempt. The number of transmural lesions was associated with arrhythmia-free survival: 25.0 % in <72 transmural lesions, 64.3 % in 72-108 transmural lesions and 71.4 % in >108 transmural lesions (p = 0.029). CONCLUSION: PV isolation can be performed successfully with the Gold-MEA catheter, with a favourable safety profile. Transmurality of lesions was associated with ablation success and may improve AF ablation success.

Dutch outcome in implantable cardioverter-defibrillator therapy (DO-IT): registry design and baseline characteristics of a prospective observational cohort study to predict appropriate indication for implantable cardioverter-defibrillator.

BACKGROUND: Implantable cardioverter-defibrillators (ICDs) are widely used for the prevention of sudden cardiac death. At present, both clinical benefit and cost-effectiveness of ICD therapy in primary prevention patients are topics of discussion, as only a minority of these patients will eventually receive appropriate ICD therapy. METHODS/DESIGN: The DO-IT Registry is a nationwide prospective cohort with a target enrolment of 1,500 primary prevention ICD patients with reduced left ventricular function in a setting of structural heart disease. The primary outcome measures are death and appropriate ICD therapy for ventricular tachyarrhythmias. Secondary outcome measures are inappropriate ICD therapy, death of any cause, hospitalisation for ICD related complications and for cardiovascular reasons. As of December 2016, data on demographic, clinical, and ICD characteristics of 1,468 patients have been collected. Follow-up will continue up to 24 months after inclusion of the last patient. During follow-up, clinical and ICD data are collected based on the normal follow-up of these patients, assuming ICD interrogations take place every six months and clinical follow-up is once a year. At baseline, the mean age was 66 (standard deviation [SD] 10) years and 27% were women. CONCLUSION: The DO-IT Registry represents a real-world nationwide cohort of patients receiving ICDs for primary prevention of sudden cardiac death with reduced left ventricular function in a setting of structural heart disease. The registry investigates the efficacy of the current practice and aims to develop prediction rules to identify subgroups who will not (sufficiently) benefit from ICD implantation and to provide results regarding costs and budget impact of targeted supply of primary preventions ICDs.

Association of apical rocking with super-response to cardiac resynchronisation therapy.

BACKGROUND: Super-responders to cardiac resynchronisation therapy (CRT) show an exceptional improvement in left ventricular ejection fraction (LVEF). Previous studies showed that apical rocking was independently associated with echocardiographic response to CRT. However, little is known about the association between apical rocking and super-response to CRT. OBJECTIVES: To determine the independent association of LV apical rocking with super-response to CRT in a large cohort. METHODS: A cohort of 297 consecutive heart failure patients treated with primary indication for CRT-D were included in an observational registry. Apical rocking was defined as motion of the left ventricular (LV) apical myocardium perpendicular to the LV long axis. 'Super-response' was defined by the top quartile of LVEF response based on change from baseline to follow-up echocardiogram. Best-subset regression analysis identified predictors of LVEF super-response to CRT. RESULTS: Apical rocking was present in 45 % of patients. Super-responders had an absolute mean LVEF increase of 27 % (LVEF 22.0 % ± 5.7 at baseline and 49.0 % ± 7.5 at follow-up). Apical rocking was significantly more common in super-responders compared with non-super-responders (76 and 34 %, P < 0.001). In univariate analysis, female gender (OR 2.39, 95 % CI 1.38-4.11), lower LVEF at baseline (OR 0.91 95 % CI 0.87-0.95), non-ischaemic aetiology (OR 4.15, 95 % CI 2.33-7.39) and apical rocking (OR 6.19, 95 % CI 3.40-11.25) were associated with super-response. In multivariate analysis, apical rocking was still strongly associated with super-response (OR 5.82, 95 % CI 2.68-12.61). Super-responders showed an excellent clinical prognosis with a very low incidence of heart failure admission, cardiac mortality and appropriate ICD therapy. CONCLUSION: Apical rocking is independently associated with super-response to CRT.

Characteristics of cardiac device infections in the Isala Hospital; a large volume tertiary care cardiology centre.

AIMS: To determine the frequency, characteristics and risk factors of cardiac device infections in the Isala Hospital. METHODS: We retrospectively studied all patients who underwent cardiac device procedures performed in the cardiac catheterisation lab and the operating room from 2010 to 2012. All patients who developed a cardiac device infection were reviewed for its characteristics. RESULTS: 31/2026 patients developed a cardiac device infection (1.5 %). One (3.2 %) patient died within 30 days of hospitalisation. Device infection rates for procedures in the catheterisation lab and operating room were similar (p = 0.60). Positive cultures were present in 27/31 (87 %) cases. These consisted predominantly of micro-organisms that are part of the skin flora (84 %). The mean time between device procedure and infection was 14 ± 21 months (range 0-79). Cardiac device infection was significantly associated with device revision, (65 % were revisions in patients with device infection vs. 30 % revisions in patients without device infection, p = 0.011) and placement of a left ventricular lead in pacemaker implantations (59 % of patients with vs. 51 % of patients without device infection, p < 0.001). CONCLUSION: The frequency of cardiac device infection was 1.5 % with a mortality of 3.2 % within 30 days, which is lower compared with other registries. Cardiac device infections were associated with device revisions and placement of left ventricular leads in pacemaker implantations.

First Dutch experience with the endoscopic laser balloon ablation system for the treatment of atrial fibrillation.

INTRODUCTION: The endoscopic laser balloon ablation system (EAS) is a relatively novel technique to perform pulmonary vein isolation (PVI) in the treatment of atrial fibrillation (AF). The present study aimed to report the results of the first 50 patients treated in the Netherlands with the EAS in terms of procedural characteristics and AF-free survival. METHODS: Fifty patients successfully underwent EAS PVI. Median follow-up was 17 months. Mean age was 56 years, 82 % had paroxysmal AF. RESULTS: 99 % of the pulmonary veins were successfully isolated with the EAS. Mean procedure time was 171 min and mean fluoroscopy time was 36 min. One procedure was complicated by a temporary phrenic nerve palsy (2 %). During follow-up, 58 % of patients remained free of AF without the use of antiarrhythmic drugs. CONCLUSION: PVI with EAS is associated with a low risk of complications and a medium-term AF-free survival comparable with other PVI techniques.

Incidence of lead dislodgement, malfunction and perforation during the first year following device implantation.

BACKGROUND: The number of cardiac rhythm device implantations has been growing fast due to expanding indications and ageing of the population. Complications of implantation were rare in the trials. However, these involved small numbers and selected patients. Prospective real-life data are necessary to assess cardiac device implantation procedure-related risks. OBJECTIVE: To determine the incidence and predictors of lead-related re-intervention in a Dutch high-volume teaching hospital. METHODS: Data from all patients who underwent cardiac rhythm device implantation between January 2010 and December 2011 were collected in a prospective registry. At least 1 year of follow-up regarding re-intervention was available for all patients. Lead-related reasons for re-intervention were categorised into lead dislodgement, malfunctioning or perforation. RESULTS: One thousand nine hundred twenty-nine devices including 3909 leads were implanted. In 595 patients (30.8 %) a CRT-D/P was implanted. Lead-related re-intervention was necessary in 86 (4.4 %) patients; it was more common in younger and male patients, and due to either lead dislodgement (66 %), malfunctioning (20 %) or perforation (18 %). Coronary sinus lead dislodgement or malfunctioning was 1.4 %. Right atrial dislodgement (1.9 %, p < 0.001) or ICD lead dislodgement (1.8 %, p = 0.002) was more common than right ventricular dislodgement (0.3 %). The incidence of lead malfunctioning was higher (0.8 %) in ICD leads. An apical position of the right ventricular lead and lateral wall position of the right atrial lead were related to cardiac perforation. CONCLUSIONS: The incidence of lead-related re-intervention was comparable with the literature. The majority of re-interventions were due to lead dislodgements, particularly with right atrial and ICD leads. Re-intervention due to coronary sinus lead dislodgement was rare.

The Zwolle experience with left bundle branch area pacing using stylet-driven active fixation leads.

AIMS: Left bundle branch area pacing (LBBAP) is a novel physiological pacing modality and is regarded as a viable alternative to His bundle pacing. LBBAP has mostly been performed with the lumen-less permanent pacing lead (SelectSecure™ Model 3830, Medtronic, Inc.) with a fixed helix. The aim of this study was to compare the non-stylet driven lumen-less lead (LLL) (Medtronic 3830) with a standard stylet-driven active fixation lead (SDL) (Tendril™ STS Model 2088TC-38, Abbott Laboratories) in terms of lead parameters, procedural success and complication rates. METHODS: Patients receiving a LBBA pacemaker in the Isala Hospital, The Netherlands, were prospectively enrolled. The majority received a standard right ventricular (RV) lead as backup, the implanter chose between LLL and SDL for the LBBAP lead. RESULTS: The study included 94 patients with a mean follow-up of 30 weeks. 30/31 LLL procedures were successful, compared with 62/63 in the SDL group. Including the participants that lost LBBAP during follow-up resulted in success rates of 90.3% for LLL versus 96.8% for SDL, P = 0.199. Mean number of deployments was significantly lower in the SDL group compared with the LLL group (2 ± 2.3 versus 4 ± 3.4, P = 0.005), implantation and procedural times were comparable. Pacing thresholds were low and remained low in both groups (at last follow-up 0.8 ± 0.30 V for LLL versus 0.6 ± 0.20 V for SDL). Complication rates did not differ significantly between both groups, P = 0.805. CONCLUSION: LBBAP using SDL is feasible and has comparable success rates with lower number of deployments of the active fixation screw.

Catheter ablation in highly symptomatic Brugada patients: a Dutch case series.

AIMS: In the past few years, promising results were described in targeting the arrhythmogenic substrate of the epicardial right ventricular outflow tract (RVOT) region in patients with Brugada syndrome (BrS). In this report, we describe our experience with endo- and epicardial substrate mapping and ablation in a series of highly symptomatic BrS patients. METHODS: This case series consists of seven patients with clinical BrS diagnosis who underwent catheter ablation in two Dutch hospitals (Isala hospital Zwolle; and Amsterdam University Medical Centre, location AMC, Amsterdam) and Hamad Heart Hospital in Qatar between 2013 and 2017. All patients had an ICD and recurrent ventricular arrhythmia (VA) episodes. All patients underwent endo-and epicardial mapping of the RVOT region. Elimination of all abnormal potentials and disappearance of BrS ECG pattern during the ablation procedure was the aimed endpoint. RESULTS: The study group consisted of seven patients with mean age 45.6 ± 16.9 years. Five patients had SCN5A mutations. One patient was excluded from analysis, since ablation could not be performed due to a very large low-voltage area and was later diagnosed with arrhythmogenic right ventricular cardiomyopathy, associated with an SCN5A mutation. One patient underwent both endo- and epicardial ablation to eliminate VA. During a mean follow-up of 3.6 ± 1.5 years, 5/6 patients remained VA free with two patients continuing quinidine. CONCLUSION: In patients with BrS and drug-refractory VA, ablation of the arrhythmogenic substrate in the RVOT region was associated with excellent long-term VA-free survival. The majority of these highly symptomatic BrS patients had an SCN5A mutation and also low-voltage areas epicardially.

Electrical storms in Brugada syndrome successfully treated with isoproterenol infusion and quinidine orally.

Brugada syndrome is an inherited cardiac disease and is associated with a peculiar pattern on the electrocardiogram and an increased risk of sudden death. Electrical storm is a malignant but rare phenomenon in symptomatic patients with Brugada syndrome. We describe a patient who presented with repetitive ICD discharges during two episodes of recurrent VF. After the initiation of isoproterenol infusion and oral quinidine, the ventricular tachyarrhythmias were successfully suppressed. (Neth Heart J 2007;15:151-4.).

Cardioverter defibrillator implantation in a patient with absent right superior vena cava.

Left-sided superior vena cava (LSVC) is the most common venous thoracic anomaly. Absence of the right superior vena cava (RSVC) on the other hand is very rare. We describe a patient with this abnormal venous system, who was admitted to our centre for an implantation of a cardioverter defibrillator (ICD).

Permanent direct His bundle pacing: initial report showing technical feasibility of an alternative pacing therapy.

To prevent deterioration of left ventricular function during right ventricular apical pacing, permanent direct His bundle stimulation can be considered in selected patients with low left ventricular ejection fraction and a normal His-ventricle conduction time. We describe our first short-term experiences with permanent direct His bundle pacing in three patients. In two patients His bundle stimulation was still effective at six weeks' follow-up. In one patient loss of capture was registered, after which conventional RV apical pacing was performed.

Sex-Based Differences in Cardiac Arrhythmias, ICD Utilisation and Cardiac Resynchronisation Therapy.

Many important differences in the presentation and clinical course of cardiac arrhythmias are present between men and women that should be accounted for in clinical practice. In this paper, we review published data on gender differences in cardiac excitable properties, supraventricular tachycardias, ventricular tachycardias, sudden cardiac death, and the utilisation of implantable defibrillators and cardiac resynchronisation therapy. Women have a higher heart rate at rest, and a longer QT interval than men. They further have a narrower QRS complex and lower QRS voltages on the 12-lead ECG with more often non-specific repolarisation abnormalities at rest. Supraventricular tachycardias, such as AV nodal reentrant tachycardia, are twice as frequent in women compared with men. Atrial fibrillation, however, has a 1.5-fold higher prevalence in men. The triggers for idiopathic right ventricular outflow tract tachycardia (VT) initiation are gender specific, i.e. hormonal changes play an important role in the occurrence of these VTs in women. There are clear-cut gender differences in acquired and congenital LQTS. Brugada syndrome affects men more commonly and severely than women. Sudden cardiac death is less prevalent in women at all ages and occurs 10 years later in women than in men. This may be related to the later onset of clinically manifest coronary heart disease in women. Among patients who receive ICDs and CRT devices, women appear to be under-represented, while they may benefit even more from these novel therapies.

Characteristics of Sprint Fidelis lead failure.

Background. The Medtronic Sprint Fidelis ICD lead is prone to failure and the rate of failure seems to be increasing. The aim of this study was to investigate the rate of Sprint Fidelis lead failure, the characteristics, the mode of presentation and possible predictors of lead failure.Methods and Results. The rate, characteristics and presentation of Sprint Fidelis lead failure was assessed in this single-centre survey. 619 Sprint Fidelis ICD leads were implanted at our centre between December 2004 and August 2007. The mean follow-up was 32+/-10 (range 22-60) months; 35 patients (5.7%) required a lead re-implantation because of failure of the pace-sense conductor. Mean duration of lead survival was 23+/-12 (2-46) months and the rate of failure did not stabilise during follow-up. The mode of presentation was inappropriate shocks in 16 patients (45.7%), alarm alert in 12 patients (34.3%), and detection at routine follow-up in seven patients (20%). In 31 patients (89%), interrogation data revealed a sudden rise in impedance and/or frequent short VV intervals prior to lead failure and in five patients an isolated decrease of R wave (<2.5 mV). The interrogation data were not different from patients with shocks compared with patients without shocks. The interrogation data at routine follow-up in the first three months after implant were normal and stable.Conclusion. The rate of Sprint Fidelis lead failure reaches 5.7% at a mean follow-up duration of 32 months. The rate of failure does not seem to stabilise. Routine follow-up can not predict lead failure or prevent inappropriate shocks. (Neth Heart J 2010;18:12-7.).