The psychological impact of implantable cardioverter-defibrillator recalls and the durable positive effects of counseling.
ABSTRACT It is known that patients with lifesaving devices such as implantable cardioverter-defibrillators (ICDs) may be alarmed and worried by recalls or alerts related to their ICDs.
This study aimed to determine whether counseling has any short- or long-term benefits, and to look for characteristics that identify those most worried and those most in need of counseling.
Among 100 patients with recall or alert ICDs, 14 were pacer dependent; 50 had ICDs for 1 degrees prevention and 22 were women. Patients completed a survey indicating how worried they were on learning of the recall or alert (0-10 scale). After counseling and advice in accordance with manufacturer guidelines, patients were asked to indicate their level of worry, and were again asked after 6 months.
For all patients, the "worry level" at the initial interview was 5.0+/-3.7, falling to 2.2+/-3.0 after counseling (P < 0.001) and 1.4+/-2.3 after 6 months (P < 0.001 vs both earlier levels). There were no significant differences between those implanted for 1 degrees versus 2 degrees prevention or for pacer dependency. Women were initially more worried than men, but not for the long term. The 49 patients whose ICDs could be managed by reprogramming or software fix had significant reduction in worry after counseling and at 6 months compared to others. The 18 patients recommended for operative intervention remained more concerned after counseling (3.5+/-3.3 vs 1.9+/-2.9, P = 0.043).
Patients' concerns resulting from ICD recalls or alerts can be reduced by appropriate counseling. Those patients whose ICDs could be reprogrammed to safer parameters had the most reduction in worry levels.
- SourceAvailable from: iranep.orgPacing and Clinical Electrophysiology 07/2006; 29(6):653-69. · 1.75 Impact Factor
- [show abstract] [hide abstract]
ABSTRACT: Psychological problems following implantable cardioverter defibrillators (ICD) implantation are diverse and include increased levels of anxiety. Anxiety may even rise further when possible malfunctioning of an ICD is announced, with a higher risk of serious ventricular arrhythmias and death as a consequence. Following the public statement of Medtronic, all patients in the Netherlands with the specific Medtronic ICD were contacted for extra device evaluation. The aim of this exploratory study was to determine whether the proportion of ICD patients with high levels of anxiety would increase after this extra device evaluation. Patients were recruited from an ongoing prospective study on psychological effects of ICD implantation. Thirty-three patients completed the State subscale of the State-Trait Anxiety Inventory (STAI) before and after extra device evaluation. The STAI can identify patients with high levels of anxiety. A high level of anxiety was experienced by two patients (6.1%) at baseline and eight patients (24.2%) at follow-up (P=0.031). Hence, ICD patients were significantly more likely to experience high levels of anxiety following the public statement of potential malfunctioning of their device. A public statement regarding device safety may increase levels of anxiety among ICD patients. Given the potential triggering effect of high levels of anxiety on arrhythmias, psychological support may be considered for some of the ICD patients after such public statement.Pacing and Clinical Electrophysiology 10/2006; 29(9):953-6. · 1.75 Impact Factor
- [show abstract] [hide abstract]
ABSTRACT: The product recall of an implantable cardioverter defibrillator (ICD) creates a potentially stressful event for patients. This study briefly describes the psychological adjustment of patients with implantable devices and makes recommendations for the management of device recalls and adverse outcomes to minimize psychological distress. Because the occurrence of ICD-specific fears and symptoms of anxiety are the most common psychological symptoms experienced by ICD recipients, a comprehensive care plan to attend to recall procedures and patient distress is needed. It is suggested that recalls do not affect all ICD patients equally, with risk factors for poor psychological adjustment to ICDs including younger age (< 50 years), shock experience, and female gender that may be associated with increased recall anxiety. Specific recommendations for device recall management include formalizing clinic responses to recall before and after implantation and innovative uses of patient support systems to communicate recall responses.The American Journal of Cardiology 09/2006; 98(4):565-7. · 3.21 Impact Factor