Elsevier

American Heart Journal

Volume 189, July 2017, Pages 75-84
American Heart Journal

Clinical Investigation
Effects of implantable cardioverter/defibrillator shock and antitachycardia pacing on anxiety and quality of life: A MADIT-RIT substudy

https://doi.org/10.1016/j.ahj.2017.03.009Get rights and content

Background

Effects of implantable cardioverter/defibrillator (ICD) shocks and antitachycardia pacing (ATP) on anxiety and quality of life (QoL) in ICD patients are poorly understood.

Methods

We evaluated changes in QoL from baseline to 9-month follow-up using the EQ-5D questionnaire in patients enrolled in the Multicenter Automatic Defibrillator Implantation Trial—Reduce Inappropriate Therapy (MADIT-RIT) (n = 1,268). We assessed anxiety levels using the Florida Shock Anxiety Scale (1-10 score) in patients with appropriate or inappropriate shocks or ATP compared to those with no ICD therapy during the first 9 months postimplant. The analysis was stratified by number of ATP or shocks (0-1 vs ≥2) and adjusted for covariates.

Results

In MADIT-RIT, 15 patients (1%) had ≥2 appropriate shocks, 38 (3%) had ≥2 appropriate ATPs. Two or more inappropriate shocks were delivered in 16 patients (1%); ≥2 inappropriate ATPs, in 70. In multivariable analysis, patients with ≥2 appropriate shocks had higher levels of shock-related anxiety than those with ≤1 appropriate shock (P < .01). Furthermore, ≥2 inappropriate shocks produced more anxiety than ≤1 inappropriate shock (P = .005). Consistently, ≥2 appropriate ATPs resulted in more anxiety than ≤1 (P = .028), whereas the number of inappropriate ATPs showed no association with anxiety levels (P = .997). However, there was no association between QoL and appropriate or inappropriate ATP/shock (all P values > .05).

Conclusions

In MADIT-RIT, ≥2 appropriate or inappropriate ICD shocks and ≥2 appropriate ATPs are associated with more anxiety at 9-month follow-up despite no significant changes in the assessment of global QoL by the EQ-5D questionnaire. Innovative ICD programming reducing inappropriate therapies may help deal with patient concerns about the device.

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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    William G. Stevenson, MD, served as guest editor for this article.

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