Optimal Programming Achieve the Goal of Maintaining Sinus Rhythm as Well as Improve Quality of Life?
A. QUESADA, V. PALANCA, J. JIMÉNEZ, O. VILLALBA, R. PAYÁ, J.R. BALAGUER, S. VILLALBA, J. RODA
Introduction
The quality of life (QoL) of patients with atrial fibrillation (AF) has been demonstrated to be worse than that of age-matched healthy subjects; either worse than or as impaired as that of patients either with a recent prior myocardial infarction or who have recently undergone coronary angioplasty;
and the same as that of patients with heart failure [1, 2]. Limitations of cur- rent drug-based strategies for AF are leading to increasing use of non-phar- macological therapies. Although atrial defibrillators (stand-alone and dual chamber defibrillators with both atrial antibradycardia and antitachycardia pacing) have shown both safety and high efficacy in suppressing AF and other regular atrial tachycardias (AT), several concerns remain regarding shock tolerance and real improvement of QoL. Thus, the impact of this type of non-pharmacological therapy on QoL is far from well-established, espe- cially when the long term is considered [3]. In this chapter we review the benefits and risks imposed to QoL both by the device and by AF itself, and how some programming strategies and psychological interventions can help us in the difficult management of patients with drug-refractory AF.
Quality of Life and Psychosocial Disturbances in AF-ICD Patients
Two fundamental premises should be emphasised. First of all, patients with AF, whether sy mptomatic or not, have impaired QoL. Secondly, QoL improves with treatment of AF, and at least some of these improvements are related to the restoration and maintenance of sinus rhythm [1–3]. Thus,
Cardiac Electrophysiology and Arrhythmias Section, Department of Cardiology, Hospital General Universitario de Valencia, Spain
when one looks for QoL changes in these patients, it is mandatory to distin- guish between those due to the arrhythmia itself and those secondary to the presence of an implanted device, and even those following discontinuation of drug therapies.
Several studies have reported QoL modifications in patients with atrial defibrillators [3, 4]. Focusing on the dual devices (with atrial and ventricular capabilities), in the AF-only study two QoL instruments were used to assess the impact of implantation of the dual implantable cardioverter–defibrillator (ICD) on patients’ QoL: the Medical Outcomes Study Short Form (SF-36), a standardised health sur vey instrument that has eight scales, and the Symptom Checklist, a disease-specific instrument. In the SF-36 there was a statistically significant improvement in Physical Function, Physical Role, Vitality, and Social Function scales from baseline to 3 months, which was sustained at 6 months’ follow-up [4]. The Symptom Checklist measures patients’ perceptions of the frequency and severity of 16 AF arrhythmia- related symptoms. A change in symptoms over time was discerned in 73 patients, and again they showed a significant decrease (improvement) from baseline to 3 months and from baseline to 6 months’ follow-up.
Programming of atrial shocks remained constant during the follow-up, and programming of patient-initiated shocks, either alone or along with timed shocks, increased from 54% of patients at baseline to 72% at last con- tact. Sixty-seven patients (67/144, 47%) used the patient assistant to deliver patient-initiated shocks.
Using the Symptom Checklist/Frequency and Severity Scale for all items and the SF-36 questionnaire, we have reported the changes after dual ICD implantation in 40 patients with refractory AF [5]. Both instruments showed significant improvements in physical activities because of health problems, in limitations in usual role activities because of physical health problems and in perceived bodily pain. The patients assigned to early delivery of atrial shock after AF onset, compared with the patients who did not receive atrial shock, showed a significant reduction of AF burden, a greater reduction in number of hospitalisations, and greater improvement of QoL.
Thus, the defibrillator effectively counteracted the reduction of QoL imposed by the arrhythmia. Possible explanations for this could be the symptomatic characteristics of the population selected, the baseline high effectiveness of the shocks (the mean number of shocks per episode was 1.2 and more than 86% of episodes required only 1 shock), and the limited num- bers of shocks during the follow-up.
The PASSAT study evaluated in 96 patients enrolled in the AF-Only Study, QoL, psychosocial distress, and acceptance of ICD therapy for atrial tach- yarrhythmias (ICD-AT) over a mean follow-up period of 19 months, [6].
From implantation to survey, a significant change in AF symptoms and
severity scores and QoL (SF-36) scores was registered. ICD-AT therapy acceptance was high, with 71.3% of patients scoring in the 75th percentile on the Florida Patient Acceptance Survey. ICD-AT acceptance was correlated with the Physical Component Scale and Mental Health Component Scale scores of the SF-36. ICD-AT acceptance correlated negatively with depressive symptomatology, trait anxiety, illness intrusiveness, and AF symptom and severity scores. ICD-AT acceptance did not correlate with preimplantation cardioversions, number of atrial shocks, AF episodes detected by the device, or device implant duration.
However, although QoL increases in many patients, in some patients psy- chological disturbances could result in reduced acceptance of atrial shocks.
Several risk factors have been identified to predict poor toleration of living with an ICD. These include young patient age, multiple ICD discharges, low social support, female gender, premorbid psychological difficulties, poor understanding of the device and the disease, and more severe medical condi- tions. Although the number of shocks is very important (both the individual and the cumulative effects of each shock), as is the experience of suffering an ICD storm, the crucial role of psychological well-being and improved per- ceived AF symptom burden for the long-term acceptance of ICD-AT therapy has been stressed [6].
The shocks will affect both the patient and his/her relatives. In the patient, the pain from the electrical discharges can generate catastrophic thinking, leading to fear and anxiety. In the relatives, shocks generate avoid- ance behaviour that increases the catastrophic thinking. In our experience, symptoms of depression and anxiety are common following the implanta- tion, arising from concerns about both the device and the disease itself. The clinical outcome and the confrontation strategies that the patients adopt will determine the psychological outcome and the acceptance of the therapy.
Adaptive, positive strategies lead to good patient–ICD coexistence, the most frequently used being spiritual or social-type strategies based on religious belief or on the confidence and support of the family or physician. Non- adaptive, negative strategies, especially avoidance and non-acceptance of the disease and device, will originate eventually lead to rejection of the treat- ment, w ith the catastrophic thinking dominated by irrational belief.
Psychologically, these irrational beliefs can be treated with cognitive therapy, such as cognitive restructuring.
Dual ICD ‘Optimal’ Programming for AF Patients
The optimisation of several programming parameters can increase the effi- cacy of the device, especially those aimed at both reducing the number of
shocks and improving their efficacy, achieving higher therapy/device accep- tance.
1. Apical ventricular pacing may be avoided. Apical right ventricular pacing alters the normal cardiac activation sequence, and there is cumulative evidence that it may induce a depression of left ventricular function. The results of several trials suggest strongly that loss of ventricular synchrony may result in increasing incidence of AF, heart failure, and death. In the MOST sub-study [7], ventricular pacing was associated with an increased risk of AF, and the risk of AF increased linearly with the cumulative per- centage of ventricular pacing (approximately 1% for each 1% increase in the latter).
Although intrinsic ventricular activation was preserved with AAI pacing, low-rate VVI pacing, fixed long AV intervals, and DDI pacing, each of these approaches has disadvantages or modest effectiveness. Recently, new atrioventricular (AV) algorithms have been developed to achieve minimal ventricular pacing. A randomised pilot study with 30 patients using one of these (MVP, Medtronic) showed an impressive reduction in cumulative percentage of ventricular pacing (3.8% vs 80.6%), maintain- ing AV synchrony [8]. More studies are required to demonstrate whether this reduction in ventricular pacing can reduce the incidence of AF.
2. Preventive and antitachycardia pacing. Some preventive algorithms are available in dual ICD defibrillators, such as atrial pacing preference and atrial rate stabilisation (provides pacing to eliminate long pauses follow- ing atrial premature beats). In the AF-only study, no effect on burden or number of episodes was observed [9], whereas in the ADOPT study [10], with a similar algorithm for atrial overdrive pacing but in a pacemaker population with associated bradycardia, a significant reduction in burden was encountered. Interestingly, it has been communicated [11] that a high percentage of ventricular pacing can counterbalance the benefits of the algorithm.
Atrial pacing therapies (ATP) have a high efficacy in suppressing many of the atrial tachycardia (AT) episodes (the most prevalent arrhythmia in this type of patients) [12–14] and might be delivered early, within or immediately after the first minute, and programmed in AT and AF zones.
Although many episodes of AF/AT last less than 1 min, the probability of inducing sustained AF with ATP is low when it is delivered in stable rhythms. In addition to ramp and burst ATP, we usually activate atrial 50- Hz burst pacing because it has a low but additive efficacy (over 5–10%
episodes in total, after the conventional ATP has been delivered).
3. Shocks, pathway, and programming. Three possible cardioversion strate- gies are available in the atrial ICD: patient self-activated, automatic, and in-hospital manually administered shocks [13, 15]. Whatever method is
used, it is mandatory to limit the number of shocks per episode and day (only one is advisable) and to try to increase their success rate. We reported a greater reduction of burden with automatic versus in-hospital manually delivered shocks, suggesting that early delivery of atrial shock after AF onset may be the best strategy [5]. Early restoration of sinus rhythm could reduce the electrophysiological remodelling process, increasing the periods of sinus rhythm and decreasing the AF burden in the long-term follow-up. Similar reductions have been observed with patient-activated shocks. However, to avoid treating self-limited episodes, a certain duration of the arrhythmia is required; the investigators of the Jewel AF, AF-only study reported a longer duration of AF prior to shock
> 3 h as one of the determinants of first-shock success [16]. Usually 6 h of sustained atrial tachyarrhythmia are programmed before shock deliv- ery.
The right-atrium-to-coronary-sinus electrode configuration significantly reduces the atrial defibrillation threshold [17]. This was also observed in the Jewel AF, AF-only study, in which the use of a coronary sinus elec- trode was accompanied by a higher success rate of shock [16]. Thus, a coronary sinus electrode should be considered in all patients undergoing evaluation for insertion of an atrial defibrillator.
4. Close monitoring after implantation and use of adjuvant treatments.
Treatment of AT/AF episodes should be aggressive shortly after implanta- tion (AF-only study, unpublished data); it results in a significant decrease in AT/AF burden, and this is accompanied by a decrease in the frequency of atrial cardioversion shocks. However, the risk of multiple shocks (even only one or two) does exist, leading to a psychological deterioration cas- cade and catastrophic and irrational thinking. Early comprehensive man- agement of the patient, including not only medical support but also psy- chological, familial ,and social monitoring and assistance, can overcome the danger of therapy rejection.
Sedation with midazolam (15 mg, elixir) significantly increases the acceptability of atrial shock regardless of the cardioversion method.
Shocks without sedation are significantly less acceptable in this type of patient [18]; if sedation is not used, automatic night cardioversion results in sleep disturbances as well as concerns about future pain or discomfort.
It is advisable not to decrease (even to increase) anti-arrhythmics drug use, together with intensive treatment of heart failure (and left ventricu- lar dysfunction). The synergistic effect of cardiac resynchronisation ther- apy is currently under investigation (RENEWAL 4 AVT study).
Thus, most drug-refractory AF-ICD patients (a heterogeneous popula- tion) accept the device and the shocks with improvement in their QoL.
Optimisation of programming can help to achieve this goal. However, the
presence of psychological disturbances in a subset of these patients make it necessary to view the hybrid therapy as a multidisciplinary task that may include not just pacing and shock therapies, drugs, and ablation techniques, but also early and intensive psychosocial monitoring and intervention.
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