Clinical InvestigationEffects of implantable cardioverter/defibrillator shock and antitachycardia pacing on anxiety and quality of life: A MADIT-RIT substudy
Section snippets
MADIT-RIT
The protocol21 and the primary article of the MADIT-RIT study have been previously published7 (trial registration site: clinicaltrials.gov; registration no.: NCT00947310). In summary, the study included 1,500 patients from 98 hospital centers with primary prevention guidelines indication to receive an ICD with or without concomitant cardiac resynchronization therapy (CRT-D). Patients were excluded if they had permanent atrial fibrillation; if they had previously been implanted with a pacemaker,
Results
Of the 1,500 patients enrolled in MADIT-RIT, 35 died within 9 months, whereas 185 did not answer the questionnaire and were consequently excluded from the present investigation. Among the remaining 1,280 patients, 97 appropriate ICD shocks occurred in the first 9 months from implantation, with 1,247 (97.4%) patients experiencing none, 18 patients (1.4%) experiencing 1, and 15 patients (1.2%) experiencing ≥2 appropriate ICD shocks (mean 5.3 shocks, range 2-20). Baseline clinical characteristics
Discussion
The major findings of the present substudy from MADIT-RIT, a primary prevention ICD trial designed to reduce the burden of inappropriate therapies using novel device programming,7 are that experience of multiple appropriate and inappropriate ICD shocks is still a significant, independent determinant of higher levels of ICD-related anxiety 9 months after implantation. A significant association was found for multiple appropriate ATP and anxiety but not for inappropriate ATP. However, overall
Limitations
This study has some limitations. During the first 9 months of the trial, 79 multiple appropriate and 87 multiple inappropriate shocks occurred only in a limited number of patients (15 [1.2%] and 16 [1.2%] subjects, respectively), whereas a single shock occurred in 18 (1.4%) and 19 (1.5%) patients, respectively. Because of the high number of multiple shocks for a single patient, we were able to demonstrate differences in perceived anxiety between this group and those receiving a single shock or
Conclusions
In ICD patients enrolled in MADIT-RIT, multiple appropriate or inappropriate ICD shocks were associated with greater device-related anxiety at 9-month follow-up despite no significant changes in the assessment of global QoL by means of the EQ-5D questionnaire. This correlation was present for appropriate ATP, whereas inappropriate ATP was not associated with anxiety. Female gender, younger age, and worse heart failure functional status were predictors of higher anxiety levels at baseline.
Disclosures
Dr A. Paoletti Perini has no conflicts of interest to declare. Dr V. Kutyifa receives research grants from Boston Scientific. Dr P. Veazie has no conflicts of interest to declare. Prof J. P. Daubert receives honoraria from ARCA biopharma, Biosense Webster, Biotronik, Boston Scientific, Cardiofocus, Gilead, Medtronic, Northwestern University, Orexigen Pharmaceuticals, St. Jude Medical, VytronUS, Heart Metabolics, and Zoll; research grants from ARCA biopharma, Biosense Webster, Boston Scientific,
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2021, Journal of the American College of CardiologyCitation Excerpt :However, survival is significantly reduced by the underlying arrhythmic substrate that triggers the various types of ICD therapies. ICD therapies and particularly shock therapy may have both physical and adverse psychological effects on the patient (17,18). Over the past decade, several studies have informed us on optimal programming of ICDs to balance the risk of inappropriate ICD therapies against the risk of failing to appropriately detect and treat VTA (4,19).
Cardiac resynchronization therapy and ventricular tachyarrhythmia burden
2021, Heart RhythmCitation Excerpt :Nevertheless, several studies have demonstrated that increased VTA burden and frequent ICD therapy are associated with a significant deterioration in patient quality of life, mental health, HF hospitalization, and death.5–7 In our study, a reduction in life-threatening VTA burden was associated with an expected reduction of appropriate shocks, which are known to have a significant effect on patient quality of life and mental health.5,6 We also showed that increasing VTA burden is directly correlated with an increased risk for subsequent mortality and HF events.
William G. Stevenson, MD, served as guest editor for this article.