Andrzej Lubiński

Defibrillator Implantation Early after Myocardial Infarction

BACKGROUNDnThe rate of death, including sudden cardiac death, is highest early after a myocardial infarction. Yet current guidelines do not recommend the use of an implantable cardioverter-defibrillator (ICD) within 40 days after a myocardial infarction for the prevention of sudden cardiac death. We tested the hypothesis that patients at increased risk who are treated early with an ICD will live longer than those who receive optimal medical therapy alone.nnnMETHODSnThis randomized, prospective, open-label, investigator-initiated, multicenter trial registered 62,944 unselected patients with myocardial infarction. Of this total, 898 patients were enrolled 5 to 31 days after the event if they met certain clinical criteria: a reduced left ventricular ejection fraction (< or = 40%) and a heart rate of 90 or more beats per minute on the first available electrocardiogram (ECG) (criterion 1: 602 patients), nonsustained ventricular tachycardia (> or = 150 beats per minute) during Holter monitoring (criterion 2: 208 patients), or both criteria (88 patients). Of the 898 patients, 445 were randomly assigned to treatment with an ICD and 453 to medical therapy alone.nnnRESULTSnDuring a mean follow-up of 37 months, 233 patients died: 116 patients in the ICD group and 117 patients in the control group. Overall mortality was not reduced in the ICD group (hazard ratio, 1.04; 95% confidence interval [CI], 0.81 to 1.35; P=0.78). There were fewer sudden cardiac deaths in the ICD group than in the control group (27 vs. 60; hazard ratio, 0.55; 95% CI, 0.31 to 1.00; P=0.049), but the number of nonsudden cardiac deaths was higher (68 vs. 39; hazard ratio, 1.92; 95% CI, 1.29 to 2.84; P=0.001). Hazard ratios were similar among the three groups of patients categorized according to the enrollment criteria they met (criterion 1, criterion 2, or both).nnnCONCLUSIONSnProphylactic ICD therapy did not reduce overall mortality among patients with acute myocardial infarction and clinical features that placed them at increased risk. (ClinicalTrials.gov number, NCT00157768.)

Consensus statement of the European Heart Rhythm Association: updated recommendations for driving by patients with implantable cardioverter defibrillators

Patients with an implantable cardioverter defibrillator (ICD) have an ongoing risk of sudden incapacitation that might cause harm to others while driving a car. Driving restrictions vary across different countries in Europe. The most recent recommendations for driving of ICD patients in Europe were published in 1997 and focused mainly on patients implanted for secondary prevention. In recent years there has been a vast increase in the number of patients with an ICD and in the percentage of patients implanted for primary prevention. The EHRA task force on ICD and driving was formed to reassess the risk of driving for ICD patients based on the literature available. The recommendations are summarized in the following table and are further explained in the document. [table: see text] Driving restrictions are perceived as difficult for patients and their families, and have an immediate consequence for their lifestyle. To increase the adherence to the driving restrictions, adequate discharge of education and follow-up of patients and family are pivotal. The task force members hope this document may serve as an instrument for European and national regulatory authorities to formulate uniform driving regulations.

Tracing the European course of cardiac resynchronization therapy from 2006 to 2008

Cardiac resynchronization therapy (CRT) is a highly efficient treatment modality for patients with severe congestive heart failure and intraventricular dyssynchrony. However, the high individual cost and technical complexity of the implantation may limit its widespread utilization. The European Heart Rhythm Association (EHRA) launched a project to assess treatment of arrhythmias in all European Society of Cardiology member countries in order to have a platform for a progressive harmonization of arrhythmia treatment. As a result, two EHRA White Books have been published in 2008 and 2009 based on governmental, insurance, and professional society data. Our aim was to analyse the local differences in the utilization of CRT, based on these surveys. A total of 41 countries provided enough data to analyse years 2006-2008. Significant differences were found in the overall number of implantations and the growth rate between 2006 and 2008. Other contributing factors include local reimbursement of CRT, the existence of national guidelines, and a high number of conventional implantable cardioverter-defibrillator implantations, while GDP or healthcare spending has less effect. Focusing on improving these factors may increase the availability of CRT in countries where it is currently underutilized.

Impact of extending device longevity on the long-term costs of implantable cardioverter-defibrillator therapy: a modelling study with a 15-year time horizon

AIMSnTo determine the long-term costs of extending device longevity in four patient populations requiring a single-chamber implantable cardioverter-defibrillator (ICD) or requiring cardiac resynchronization therapy with defibrillation (CRT-D) device over a 15-year time window.nnnMETHODS AND RESULTSnWe considered patient populations with an accepted indication for a single-chamber ICD for prevention of sudden cardiac death in the context of preserved (Population A) or impaired (Population B) left ventricular function; or with indication for a CRT-D device in the context of heart failure in New York Heart Association class II (Population C) or III (Population D). Expected patient survival and a cost analysis, including the cost of complications, was undertaken from a hospital perspective. Extended device longevity of 5 vs. 9 years for ICDs (Populations A and B); 4 vs. 7 years for CRT-Ds (Populations C and D) were considered. Over a 15-year time horizon, total, yearly, and per diem savings, per patient, from extending ICD longevity to 9 years were €10 926.91, €728.46, and €1.99 for Population A, and €7661.32, €510.75, and €1.40 for Population B. Total, yearly, and per diem savings from extending CRT-D longevity to 7 years were €13 630.38, €908.69, and €2.49 for Population C, and €10 968.29, €731.22, and €2.00 for Population D. Avoidance of a generator replacement amounted up to 46.6-62.5% of the saving.nnnCONCLUSIONnExtending device longevity has an important effect on the long-term cost of device therapy, both for ICD and CRT-D. This has important implications for device choice.

Device therapy and hospital reimbursement practices across European countries: a heterogeneous scenario

As in other settings, in the field of clinical use of cardiac implantable electrical devices (CIEDs), the implementation, in various ways, of diagnosis-related groups (DRGs) has created new scenarios in most European healthcare systems. A DRG system is primarily a financial tool with the aim of promoting efficiency and improving utilization of resources. However, there are a variety of ways in which this system is used for funding the activity of centres implanting CIEDs. It is possible that the specific type and method of reimbursement may influence the implementation of CIEDs in the real world through a variable spectrum of practices. These may range from the situation where reimbursement may, together with other factors, constitute a true barrier to the implementation of guidelines, to scenarios where reimbursement is adequate, and/or to situations where reimbursement may be adequate for standard devices but not for prompt implementation of effective technological innovations. The variety in reimbursement also affects how in-office checks of CIEDs are covered and, above all, the possibility to pay for remote follow-up of CIEDs. In the field of medical devices, refinement of DRG systems and adoption of new strategies and policies are needed to sustain and enhance those effective technological innovations that may be beneficial for specific patient populations. It is also important that physicians are deeply involved in the development and deployment of DRGs, and that each country DRGs agency has a transparent approach to engagement with stakeholders, along with robust and transparent mechanisms for updating these systems.

Determinants of geographic variations in implantation of cardiac defibrillators in the European Society of Cardiology member countries--data from the European Heart Rhythm Association White Book.

AIMSnSudden cardiac death (SCD) is a major health concern in developed countries. Many studies have demonstrated the efficacy of implantable cardioverter defibrillator (ICD) therapy in the prevention of SCD and total mortality reduction. However, the high individual costs and the reimbursement policy may limit widespread ICD utilization.nnnMETHODS AND RESULTSnThis study analyzed the temporal and the geographical trends of the ICD implantation rate. Data were gathered from two editions of the European Heart Rhythm Association (EHRA) White Books published in 2008 and 2009. The analysis revealed significant differences in the rates of ICD implantation per million capita between the countries, but the median implantations was constantly increasing. The number of ICD implantations correlated with gross domestic product (GDP), GDP per capita, expenditure on health, life expectancy, and the number of implanting centres.nnnCONCLUSIONnThere are great number of differences in the ICD-implanting rates between EHRA member countries, consequent to the increase in the number of ICD implantations. The ICD implantation rates are related to national economic status and healthcare expenses.

Barriers to implementation of evidence-based electrical therapies and the need for outcome research: role of European registries

Although clinical trial results and the implementation of current guidelines appear to have encouraged progress in the treatment of arrhythmias, great discrepancies still exist between European Society of Cardiology (ESC) member countries. Guidelines are not adhered to for a variety of reasons. This cannot be explained only by economic factors, although these obviously play a substantial role. Other factors responsible for adequate guideline implementation appear to be the lack of trained personnel, the lack of infrastructure, or different health insurance systems. In this complex scenario, the data based on European registries are useful for creating standards and harmonizing the treatment of arrhythmias. Moreover, a summary of registry data, such as presented in the European Heart Rhythm Association (EHRA) White Book, can provide the opportunity to share and exchange information among ESC member countries on specific needs for improvements, reimbursement policy, and training issues.

The effect of diabetic autonomic neuropathy on P-wave duration, dispersion and atrial fibrillation.

Introduction Atrial fibrillation (AF) is the most common sustained arrhythmia. Diabetic autonomic neuropathy (DAN) is a frequent complication of diabetes mellitus and has a negative impact on the cardiovascular system. There are no data about the occurrence of paroxysmal atrial fibrillation (PAF) in the population with DAN. Material and methods We analysed the data of 100 patients with PAF. The study population was divided into three groups: group I: 28 patients with diabetes mellitus (DM) and DAN, group II: 34 patients with DM without DAN, and group III: 38 patients without DM. P-wave duration (FPD) and dispersion (PWD) were measured during sinus rhythm and AF episodes were counted during 12 months of follow-up. Results Recurrence of PAF was higher in group I (47 episodes/year) compared to groups II and III (26 and 22 episodes/year) – p<0.01. The FPD was longer in group I (137.4 ±12.0 ms vs. 126 ±23.0 ms in II group and 129 ±18.3 ms in group III; p<0.001). The PWD was longer in patients with DAN (53 ±19 ms vs. 36 ±18 ms and 34 ± 20 ms, p<0.001). Conclusions The results showed that the presence of DAN caused a significant increase in P-wave duration and dispersion, which might be responsible for the recurrence of AF.

A randomized trial of budiodarone in paroxysmal atrial fibrillation

ObjectiveThe aim of this study was to investigate the preliminary safety and efficacy of three doses of budiodarone in patients with paroxysmal atrial fibrillation.BackgroundBudiodarone is a chemical analogue of amiodarone and shares its mixed ion channel electrophysiological properties. It has a shorter half-life than amiodarone.MethodsPatients with paroxysmal atrial fibrillation and a previously implanted dual-chamber pacemaker capable of storing electrograms for at least 4xa0weeks were enrolled. Pacemaker memories were used to quantify atrial tachycardia/atrial fibrillation burden (AT/AFB). All antiarrhythmic drugs were stopped for greater than five half-lives and amiodarone greater than 3xa0months prior to enrollment. Following a 4-week baseline period to assess AT/AFB off antiarrhythmic drugs, patients with AT/AFB between 3% and 70% were blindly randomized to placebo, 200, 400, or 600xa0mg BID of budiodarone for 12xa0weeks followed by a 4-week washout period. Pacemakers were interrogated and safety assessed every 4xa0weeks. Pacemaker-derived electrograms were adjudicated blinded to treatment assignment. The primary study endpoint was percent change from baseline AT/AFB over 12xa0weeks of treatment compared to placebo.ResultsOf 72 randomized patients, 61 completed the study. The median reduction of AT/AFB for the 400 and 600xa0mg BID groups vs. placebo was 54% and 74% (pu2009=u20090.01 and 0.001), respectively. The budiodarone dose–response was statistically significant (pu2009<u20090.001). Number and duration of AT/AF episodes were reduced.ConclusionsIn this preliminary study, budiodarone at both higher doses significantly reduced AT/AFB. The study is novel because dual-chamber pacemakers, previously placed for standard clinical indications, were successfully used to monitor AT/AFB.

Consensus statement of the European Heart Rhythm Association: Updated recommendations for driving by patients with implantable cardioverter defibrillators

Patients with an implantable cardioverter defibrillator (ICD) have an ongoing risk of sudden incapacitation that might cause harm to others while driving a car. Driving restrictions vary across different countries in Europe. The most recent recommendations for driving of ICD patients in Europe were published in 1997 and focused mainly on patients implanted for secondary prevention. In recent years there has been a vast increase in the number of patients with an ICD and in the percentage of patients implanted for primary prevention. The EHRA task force on ICD and driving was formed to reassess the risk of driving for ICD patients based on the literature available. The recommendations are summarized in the following table and are further explained in the document. Restriction for private driving Restriction for professional driving ICD implantation for secondary prevention Three months Permanent ICD implantation for primary prevention Four weeks Permanent After appropriate ICD therapy Three months Permanent After inappropriate ICD therapy Until measures to prevent inappropriate therapy are taken Permanent After replacement of the ICD One week Permanent After replacement of the lead system Four weeks Permanent Patients refusing ICD for primary prevention No restriction Permanent Patients refusing ICD implantation for secondary prevention Seven months Permanent Driving restrictions are perceived as difficult for patients and their families, and have an immediate consequence for their lifestyle. To increase the adherence to the driving restrictions, adequate discharge of education and follow-up of patients and family are pivotal. The task force members hope this document may serve as an instrument for European and national regulatory authorities to formulate uniform driving regulations.