Trends in replacement of pacemaker leads in the Netherlands: A long-term nationwide follow-up study.

BACKGROUND: Our objective was to investigate trends over time in longevity and reasons for replacement with or without extraction of pacemaker leads after first implantation. METHODS: Data collected between 1984 and 2006 in the national Dutch pacemaker registry were used. This registry covered 84% of sold leads. First lead replacement with or without extraction of one or more leads implanted with a first pacemaker generator was the endpoint of interest. The time interval of and reason for first replacement were analyzed. A 7-year follow-up interval after first implantation was used to analyze changes over time. RESULTS: During 22 years of data collection, 138,225 leads were implanted with a first pacemaker generator. Within a mean 5.5 (SD 4.4) years for 7,377 patients one or more leads were extracted for the first time. In total, 8,849 leads (6.4%) were replaced or extracted. The main reasons for first replacement of leads with or without extraction were insulation failures (14.6%), infection (8.8%), displacement (7.6%), or for elective reasons (10.0%). The number of insulation failures peaked during 1991-1995. CONCLUSIONS: Despite improvements in pacing techniques and experience with cardiac devices, we found that insulation and conductor failures, and complications such as infections, did not diminish over the 20 years of the registry. Continuing attention in clinical practice for the evaluation of these adverse outcomes and maintaining quality registries is warranted, whereas manufacturers should use this information to further improve their devices.

Trends in service time of pacemakers in the Netherlands: a long-term nationwide follow-up study.

AIMS: After decades of experience and strongly improved technology, service time of pacemaker generators is expected to increase. To test this hypothesis, we conducted a retrospective review of a large cohort of patients with a pacemaker. METHODS: We reviewed data collected between 1984 and 2006 in the first national Dutch pacemaker registry. This registry covered 96% of all generators implanted. We analysed the time of and reason for explantation of pacemaker generators. A 7-year follow-up interval after first implantation and following replacements was used to analyse changes over time. RESULTS: During 22 years of data collection, nearly 97,000 first pacemaker generators were implanted. A total of 27,937 (22.4%) generators were explanted within a mean of 6.3 (standard deviation 3.3) years. Reasons for approximately 60% of these explantations were 'end of life' of the pacemaker generator or elective system change. Complications or failures such as infections and recalls accounted for approximately 20% of the explantations. For the remaining 20%, the reasons for explantation had not been registered. CONCLUSION: Despite progress in technology, a substantial proportion of pacemaker generators is explanted before its expected service time, with one in five generators being replaced due to technical failures, infections or other complications. Furthermore, the time interval between pacemaker implantation and explantation due to normal 'end of life' (battery EOL) decreased. Infections continue to rank highly as a cause for pacing system replacement, despite all current preventive measures.

Utilisation of cardiac pacemakers over a 20-year period: Results from a nationwide pacemaker registry.

The implantation of cardiac pacemakers has become a well-established therapy for conduction disorders and sinus node dysfunction. In many countries pacemaker registries have been initiated in order to collect information on patient characteristics, trends in numbers and the types of pacemakers used, to identify problematic devices, and for safety monitoring. For this utilisation study the Central Pacemaker Patients Registration (CPPR) from the Netherlands Pacemaker Registry Foundation (CPPR-SPRN) containing data collected for more than 20 years was used. During this period nearly 97,000 first pacemakers were implanted. Analyses show an increase in the rate of implanted devices. The change in pacemaker type from VVI to DDD, followed by biventricular stimulation, is reflected by the number of simultaneously implanted leads, which is partly a consequence of cardiac resynchronisation therapy. Our data demonstrate that indications for implantation and type of pacemaker are comparable with other European countries.

Quality of care: not hospital but operator volume of pacemaker implantations counts.

Literature about pacemaker (PM) implantations shows that several clinical and technical factors determine the short- and long-term complications after the intervention. Annual hospital volume, however, does not negatively affect complications in contrast with the cumulative experience of the operator. In view of this observation, the current required number of 20 to 30 first PM implantations for cardiology training does not match standards for quality of care. In addition, concentration of implants and replacement of pacemakers to a limited number of operators per hospital to comply with the increasing demands of patients and other parties has to be seriously considered.

Patients with left bundle branch block pattern and high cardiac risk myocardial SPECT: does the current management suffice?

INTRODUCTION: Myocardial perfusion SPECT (MPS) is frequently used for cardiovascular risk stratification. The significance of MPS in patients with abnormal electrical ventricular activation is often questionable. This review assesses the value of MPS for risk stratification of patients with intrinsic left bundle branch block or that due to right ventricular apical pacing. METHODS: We reviewed the literature by a search of the MEDLINE database (January 1980 to September 2010). The terms prognosis or prognostic value were combined with SPECT and LBBB or pacing or pacemakers. MPS was categorised as low and high risk according to the original definitions. RESULTS: We identified 11 studies suitable for review. A low-risk MPS is associated with a low risk of cardiac events whereas high-risk MPS carries a 4.8-fold increased risk, 95% CI [3.2 - 7.2] (p < 0.0001). Despite secondary prevention and an improved medical and interventional care, these figures have hardly changed over time. CONCLUSION AND CLINICAL IMPLICATIONS: A low-risk MPS permits a policy of watchful waiting whereas a high-risk MPS requires further analysis and treatment. The persistent high cardiac death and acute myocardial infarction rate after a high-risk MPS suggest that the current management of these patients does not suffice and needs reconsideration.

Remote monitoring and follow-up of cardiovascular implantable electronic devices in the Netherlands : An expert consensus report of the Netherlands Society of Cardiology.

Remote monitoring of cardiac implanted electronic devices (CIED: pacemaker, cardiac resynchronisation therapy device and implantable cardioverter defibrillator) has been developed for technical control and follow-up using transtelephonic data transmission. In addition, automatic or patient-triggered alerts are sent to the cardiologist or allied professional who can respond if necessary with various interventions. The advantage of remote monitoring appears obvious in impending CIED failures and suspected symptoms but is less likely in routine follow-up of CIED. For this follow-up the indications, quality of care, cost-effectiveneness and patient satisfaction have to be determined before remote CIED monitoring can be applied in daily practice. Nevertheless remote CIED monitoring is expanding rapidly in the Netherlands without professional agreements about methodology, responsibilities of all the parties involved and that of the device patient, and reimbursement. The purpose of this consensus document on remote CIED monitoring and follow-up is to lay the base for a nationwide, uniform implementation in the Netherlands. This report describes the technical communication, current indications, benefits and limitations of remote CIED monitoring and follow-up, the role of the patient and device manufacturer, and costs and reimbursement. The view of cardiology experts and of other disciplines in conjunction with literature was incorporated in a preliminary series of recommendations. In addition, an overview of the questions related to remote CIED monitoring that need to be answered is given. This consensus document can be used for future guidelines for the Dutch profession.

Peak longitudinal strain delay is superior to TDI in the selection of patients for resynchronisation therapy.

BACKGROUND: Mechanical dyssynchrony has proven to be superior to QRS duration in predicting response to cardiac resynchronisation therapy (CRT). Whether time to peak longitudinal strain delay between the mid-septum and mid-lateral left ventricular wall better predicts CRT response than tissue Doppler imaging (TDI) is unclear. This study compares the value of the two methods for the assessment of mechanical dyssynchrony and prediction of CRT responders. METHODS: 66 clinical responders and 17 nonresponders to CRT with severe systolic heart failure (LVEF <35%), New York Heart Association classification III or IV and a wide QRS >130 ms with left bundle branch block were evaluated by peak longitudinal strain and TDI. Doppler echocardiograms and electromechanical time delay (EMD) intervals were acquired before and after pacemaker implantation. RESULTS: In all responders EMD measured by peak longitudinal strain was >60 ms before implantation, compared with 76% of the patients measured by TDI. Nonresponders had EMD <60 ms measured by both techniques. Only peak longitudinal strain delay showed shortened values in every responder postimplantation and demonstrated the most significant reduction and could predict responders to CRT. However, EMD measured by TDI did not diminish in 30% of the positive clinical responders. Nonresponders showed worsening of the EMD with peak longitudinal strain, but not with TDI. CONCLUSIONS: Responders to CRT can be excellently predicted if EMD before implantation determined by peak longitudinal strain delay is >60 ms. Peak longitudinal strain delay appears to be superior to TDI to predict the response to CRT. (Neth Heart J 2010;18:574-82.).

Left ventricular dysfunction due to right ventricular stimulation: is biventricular upgrade really necessary?

Left ventricular (LV) dysfunction can occur due to chronic right ventricular apical pacing. Upgrading of the pacemaker to biventricular pacing is an option to reverse LV dysfunction but reprogramming of the atrioventricular (AV) timing can also be favourable. In this case report we describe the effect of AV-time reprogramming in a patient with LV function deterioration that emerged two years after implantation of a dual chamber system for sick sinus syndrome. Echocardiographc studies demonstrated a tremendous improvement in LV function during two years follow-up whereas the percentage of right ventricular pacing diminished dramatically. Careful analysis of the cause of LV deterioration can avoid unnecessary upgrading to biventricular pacing. (Neth Heart J 2010;18:604-5.).

Remote monitoring of implanted cardiac devices: a plea for a nationwide exploration.

Remote monitoring of implanted cardiac devices is an evolving method for regular checks of their electronic integrity and functioning. The communication with the devices is carried out unsupervised with wireless trans-telephonic or cable-dependent linkage. The interrogation of the device examines several programmed functions and harvests the stored data of numerous events. The collected data constitute the base to decide whether the implanted device is operating properly and can give some information about the physical condition of the device recipient. Preliminary short-term results show favourable effects in terms of safety and cost and time saving as compared with the current face-to-face visits of conventional patient follow-ups. Remote monitoring of implanted devices will extend markedly in the coming years and its development touches many questions ranging from technical accuracy, patient benefit, cost-effectiveness and responsibilities of the provider and receivers of the delivered device data, to the role of the cardiologist and allied professionals and of course privacy rules. In this point of view, these questions are discussed in order to explore the consequences of device remote monitoring with nationwide Trials. (Neth Heart J 2009;17:434-7.).

Clinical application of pacemakers in atrial tachyarrhythmias.

The diagnostic programmes of modern pacemakers have increased our knowledge of atrial tachyarrhythmias (ATAs) in chronically paced patients. These programmes also support the evaluation of the effects of pharmacological treatment of ATAs. The success of interruption and/or prevention of ATAs with pacemakers depends strongly on the diagnostic accuracy and the properties of the pacing algorithms, their individual programming and the site and configuration of the pacing leads. Atrial septum pacing can be beneficial in patients with paroxysmal atrial fibrillation and prolonged P wave duration. Recent large-scale studies on preventive and interruptive atrial pacing of ATAs show modestly positive or no results. Therefore, atrial pacing therapy for ATAs should be considered cautiously, serving as an adjuvant to pharmacological treatment rather than as a primary intervention. This also applies for pacing interventions for ATAs in cardiac resynchronisation therapy. The pacemaker algorithms for the detection of ATAs and atrial lead configuration are crucial for the success of pacemaker-mediated prevention or interruption of ATAs. The success of these interventions is dependant on future improvements of pacemaker technology. (Neth Heart J 2008;16(Suppl1):S20-S24.).