Dutch outcome in implantable cardioverter-defibrillator therapy (DO-IT)

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 i

Short-Term Variability of the QT Interval Can be Used for the Prediction of Imminent Ventricular Arrhythmias in Patients With Primary Prophylactic Implantable Cardioverter Defibrillators

Background Short-term variability of the QT interval (STVQT) has been proposed as a novel electrophysiological marker for the prediction of imminent ventricular arrhythmias in animal models. Our aim is to study whether STVQT can predict imminent ventricular arrhythmias in patients. Methods and Results In 2331 patients with primary prophylactic implantable cardioverter defibrillators, 24-hour ECG Holter recordings were obtained as part of the EU-CERT-ICD (European Comparative Effectiveness Research to Assess the Use of Primary Prophylactic Implantable Cardioverter Defibrillators) study. ECG Holter recordings showing ventricular arrhythmias of >4 consecutive complexes were selected for the arrhythmic groups (n=170), whereas a control group was randomly selected from the remaining Holter recordings (n=37). STVQT was determined from 31 beats with fiducial segment averaging and calculated as [Formula: see text], where Dn represents the QT interval. STVQT was determined before the ventricular arrhythmia or 8:00 am in the control group and between 1:30 and 4:30 am as baseline. STVQT at baseline was 0.84±0.47 ms and increased to 1.18±0.74 ms (P<0.05) before the ventricular arrhythmia, whereas the STVQT in the control group remained unchanged. The arrhythmic patients were divided into three groups based on the severity of the arrhythmia: (1) nonsustained ventricular arrhythmia (n=32), (2) nonsustained ventricular tachycardia (n=134), (3) sustained ventricular tachycardia (n=4). STVQT increased before nonsustained ve

Development and external validation of prediction models to predict implantable cardioverter-defibrillator efficacy in primary prevention of sudden cardiac death

Aims This study was performed to develop and externally validate prediction models for appropriate implantable cardioverter-defibrillator (ICD) shock and mortality to identify subgroups with insufficient benefit from ICD implantation.Methods and results We recruited patients scheduled for primary prevention ICD implantation and reduced left ventricular function. Bootstrapping-based Cox proportional hazards and Fine and Gray competing risk models with likely candidate predictors were developed for all-cause mortality and appropriate ICD shock, respectively. Between 2014 and 2018, we included 1441 consecutive patients in the development and 1450 patients in the validation cohort. During a median follow-up of 2.4 (IQR 2.1-2.8) years, 109 (7.6%) patients received appropriate ICD shock and 193 (13.4%) died in the development cohort. During a median follow-up of 2.7 (IQR 2.0-3.4) years, 105 (7.2%) received appropriate ICD shock and 223 (15.4%) died in the validation cohort. Selected predictors of appropriate ICD shock were gender, NSVT, ACE/ARB use, atrial fibrillation history, Aldosterone-antagonist use, Digoxin use, eGFR, (N)OAC use, and peripheral vascular disease. Selected predictors of all-cause mortality were age, diuretic use, sodium, NT-pro-BNP, and ACE/ARB use. C-statistic was 0.61 and 0.60 at respectively internal and external validation for appropriate ICD shock and 0.74 at both internal and external validation for mortality.Conclusion Although this cohort study was specifically designed to develop prediction models, risk stratification still remains challenging and no large group with insufficient benefit of ICD implantation was found. However, the prediction models have some clinical utility as we present several scenarios where ICD implantation might be postponed.Cardiolog

Cardiac resynchronization therapy beyond nominal settings: who needs individual programming of the atrioventricular and interventricular delay?

Compared with the best of the currently available device nominal AV and VV delays, 23–45% of CRT patients can yield additional acute haemodynamic effect by individual optimization of the delays. A new nominal VV delay of 40 ms LV pre-activation is recommended. Male gender, ischaemic aetiology, and longer PR interval are associated with a larger effect of individual optimization

Heart failure and atrial fibrillation: current concepts and controversies

C.P. Chemical Company appeals from a judgment of the United States District Court for the Southern District of New York (Brieant, J.) dismissing its complaint against the United States and the Consumer Product Safety Commission ( Commission or agency ) under the Federal Tort Claims Act, 28 U.S.C. §§ 1346(b), 2671-80 ( FTCA ), and the Consumer Product Safety Act, 15 U.S.C. § 2053(h) ( CPSA ), for lack of subject matter jurisdiction and failure to state a claim. The suit arose from the Commission\u27s ban on the use of formaldehyde-emitting foam insulation, 47 Fed.Reg. 57,488 (1982). The Fifth Circuit ruled, in Gulf South Insulation v. U.S. Consumer Product Safety Commission, 701 F.2d 1137, 1148-50 (5th Cir.1983), that the ban was improper because it was promulgated under the procedures of the CPSA, 15 U.S.C. §§ 2057, 2058, 2079(d), rather than under the appropriate procedures of the Federal Hazardous Substances Act, 15 U.S.C. §§ 1261-1276. C.P. Chemical alleged that the Commission erroneously included within the ban its insulation product, Tripolymer, which emits no formaldehyde gas. The district court held that the FTCA waiver of sovereign immunity does not extend to the agency conduct forming the basis for this tort action against the United States and the Commission. The court also held that the CPSA provides no predicate for this action. For the reasons stated below, we affirm

Quality of life in patients with paroxysmal atrial fibrillation and its predictors: importance of the autonomic nervous system

Aims To determine the impact of paroxysmal atrial fibrillation on quality of life and to determine the predictors of quality of life, particularly the role of symptomatology and autonomic function.Methods and Results The study group comprised 73 patients with paroxysmal atrial fibrillation (mean age 541 years, 51 males). On average, patients had a 3-year history of one paroxysm per week lasting 2 h. Quality of life was assessed using the SF-36 (Medical Outcomes Study Short-Form Health Survey) and compared with age-matched controls. Autonomic function was assessed using Holter monitoring with analysis of heart rate variability and autonomic function tests. Symptoms during paroxysms of atrial fibrillation were also scored. Multivariate analysis was performed to identify independent predictors of quality of life. Quality of life scores were markedly lower in patients than in controls in four of the eight subscales (P<0.001): physical role function, emotional role function, vitality and general health. Structural heart disease did not predict quality of life, whereas frequency of paroxysms was predictive only of physical role function. In contrast, autonomic variables (baroreflex-sensitivity, total power (heart rate variability), response to deep breathing, 30-15 ratio (standing up)) were predictive in all four respective subscales (P<0.05), depressed vagal function being predictive of low scores. Symptoms, particularly severe perspiration, were also predictive of low scores (P<0.05).Conclusions This study shows that paroxysmal atrial fibrillation causes significant impairment of quality of life. Further, symptomatology and autonomic function are important predictors of quality of life in this patient group. (C) 2001 The European Society of Cardiology

Multimodality imaging for real-time image-guided left ventricular lead placement during cardiac resynchronization therapy implantations

This study was performed to evaluate the feasibility of intra-procedural visualization of optimal pacing sites and image-guided left ventricular (LV) lead placement in cardiac resynchronization therapy (CRT). In fifteen patients (10 males, 68 ± 11 years, 7 with ischemic cardiomyopathy and ejection fraction of 26 ± 5%), optimal pacing sites were identified pre-procedurally using cardiac imaging. Cardiac magnetic resonance (CMR) derived scar and dyssynchrony maps were created for all patients. In six patients the anatomy of the left phrenic nerve (LPN) and coronary sinus ostium was assessed via a computed tomography (CT) scan. By overlaying the CMR and CT dataset onto live fluoroscopy, aforementioned structures were visualized during LV lead implantation. In the first nine patients, the platform was tested, yet, no real-time image-guidance was implemented. In the last six patients real-time image-guided LV lead placement was successfully executed. CRT implant and fluoroscopy times were similar to previous procedures and all leads were placed close to the target area but away from scarred myocardium and the LPN. Patients that received real-time image-guided LV lead implantation were paced closer to the target area compared to patients that did not receive real-time image-guidance (8 mm [IQR 0–22] vs 26 mm [IQR 17–46], p = 0.04), and displayed marked LV reverse remodeling at 6 months follow up with a mean LVESV change of −30 ± 10% and a mean LVEF improvement of 15 ± 5%. Real-time image-guided LV lead implantation is feasible and may prove useful for achieving the optimal LV lead position