Dataset Information

Patient plus partner trial: A randomized controlled trial of 2 interventions to improve outcomes after an initial implantable cardioverter-defibrillator.

ABSTRACT:

Background

Interventions to improve physical and psychological outcomes in recipients with an initial implantable cardioverter-defibrillator (ICD) and their intimate partners are largely unstudied, though likely to have a major impact on adjustment to the ICD and general well-being.

Objective

The purpose of this study was to report the primary outcomes of the patient plus partner randomized controlled trial.

Methods

In a 2-group (N = 301) prospective randomized controlled trial, we compared 2 social-cognitive-based intervention programs-patient plus partner (P+P) and patient only (P only)-implemented after initial ICD implantation. The patient intervention, consisting of educational materials, nurse-delivered telephone coaching, videotape demonstrations, and access to a nurse via a 24/7 pager, was implemented in both groups. P+P also incorporated partner participation. The primary patient outcomes were symptoms and anxiety at 3 months. Other outcomes were physical function (SF-36 [Short Form 36] and ICD shocks-patient), psychological adjustment (PHQ-9 [Patient Health Questionaire-9]), relationship impact (Dyadic Adjustment Scale and Oberst Caregiving Burden Scale (DAS and OCBS) partner), self-efficacy and knowledge (Sudden Cardiac Arrest-Self Efficacy [SCA-SE], Sudden Cardiac Arrest-Outcomes Expectation [SCA-OE], and Knowledge Self-Assessment [KSA]), and health care utilization (outpatient visits and hospitalizations) at hospital discharge and 1, 3, 6, and 12 months post-ICD implantation.

Results

For patients, P+P compared with P only was more effective in improving symptoms (P = .02), depression (P = .006), self-efficacy (P = .02), outcome expectations (P = .03), and knowledge (P = .07). For partners, P+P was more effective in improving partner caregiver burden (P = .002), self-efficacy (P = .001), and ICD knowledge (P = .04).

Conclusion

An intervention that integrated the partner into the patient's recovery after an ICD improved outcomes for both. Beyond survival benefits of the ICD, intervention programs designed to address both the patient and their partner living successfully with an ICD are needed and promising.

SUBMITTER: Dougherty CM

PROVIDER: S-EPMC6399067 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Publications

Patient plus partner trial: A randomized controlled trial of 2 interventions to improve outcomes after an initial implantable cardioverter-defibrillator.

Dougherty Cynthia M CM Thompson Elaine A EA Kudenchuk Peter J PJ

Heart rhythm 20181016 3

<h4>Background</h4>Interventions to improve physical and psychological outcomes in recipients with an initial implantable cardioverter-defibrillator (ICD) and their intimate partners are largely unstudied, though likely to have a major impact on adjustment to the ICD and general well-being.<h4>Objective</h4>The purpose of this study was to report the primary outcomes of the patient plus partner randomized controlled trial.<h4>Methods</h4>In a 2-group (N = 301) prospective randomized controlled t ...[more]

PMID: 30340060

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Project description:BackgroundThere are conflicting data on the impact of implantable cardioverter-defibrillator (ICD) shocks on subsequent mortality.ObjectivesThe aim of this study was to determine whether the arrhythmic substrate leading to ICD therapy or the therapy itself increases mortality.MethodsThe study cohort included 5,516 ICD recipients who were enrolled in 5 landmark ICD trials (MADIT-II, MADIT-RISK, MADIT-CRT, MADIT-RIT, RAID). The authors evaluated the association of device therapy with subsequent mortality in 4 separate time-dependent models: model I, type of ICD therapy; model II, type of arrhythmia for which ICD therapy was delivered; model III, combined assessment of all arrhythmia and therapy types during follow-up; and model IV, incremental risk associated with repeated ICD shocks.ResultsWhen analyzed by the type of ICD therapy (model I), a first appropriate ICD shock was associated with increased risk of subsequent mortality with or without concomitant occurrence of inappropriate shock during follow-up (hazard ratio [HR]: 2.78 and 2.31; p < 0.001 and p = 0.12), whereas inappropriate shock alone was not associated with mortality risk (HR: 1.23; p = 0.42). Similarly, ICD therapy for ventricular tachycardia (VT) ≥200 beats/min or ventricular fibrillation (VF) (model II) was associated with increased risk of death with or without concomitant therapy for VT <200 beats/min (HRs: 2.25 and 2.62; both p < 0.001), whereas appropriate therapy for VT <200 beats/min or inappropriate therapy (regardless of etiology) did not reach statistical significance (all p > 0.10). Combined assessment of all therapy and arrhythmia types during follow-up (model III) showed that appropriate ICD shocks for VF, shocks for fast VT (≥200 beats/min) without prior antitachycardia pacing (ATP), as well as shocks for fast VT delivered after failed ATP, were associated with the highest risk of subsequent death (HR: all >2.8; p < 0.001). Finally, 2 or more ICD appropriate shocks were not associated with incremental risk to the first appropriate ICD shock (model IV).ConclusionThe combined data from 5 landmark ICD trials suggest that the underlying arrhythmic substrate rather than the ICD therapy is the more important determinant of mortality in ICD recipients.

Project description:Background One third of primary prevention implantable cardioverter-defibrillator patients receive appropriate therapy, but all remain at risk of defibrillator complications. Information on these complications in contemporary cohorts is limited. This study assessed complications and their risk factors after defibrillator implantation in a Dutch nationwide prospective registry cohort and forecasts the potential reduction in complications under distinct scenarios of updated indication criteria. Methods and Results Complications in a prospective multicenter registry cohort of 1442 primary implantable cardioverter-defibrillator implant patients were classified as major or minor. The potential for reducing complications was derived from a newly developed prediction model of appropriate therapy to identify patients with a low probability of benefitting from the implantable cardioverter-defibrillator. During a follow-up of 2.2 years (interquartile range, 2.0-2.6 years), 228 complications occurred in 195 patients (13.6%), with 113 patients (7.8%) experiencing at least one major complication. Most common ones were lead related (n=93) and infection (n=18). Minor complications occurred in 6.8% of patients, with lead-related (n=47) and pocket-related (n=40) complications as the most prevailing ones. A surgical reintervention or additional hospitalization was required in 53% or 61% of complications, respectively. Complications were strongly associated with device type. Application of stricter implant indication results in a comparable proportional reduction of (major) complications. Conclusions One in 13 patients experiences at least one major implantable cardioverter-defibrillator-related complication, and many patients undergo a surgical reintervention. Complications are related to defibrillator implantations, and these should be discussed with the patient. Stricter implant indication criteria and careful selection of device type implanted may have significant clinical and financial benefits.

Project description:BackgroundSexual concerns and changes in sexual activity are common among patients and their intimate partners after an implantable cardioverter defibrillator (ICD).AimsOur aims were to (i) describe patient and partner sexual activity and related concerns from the time of an initial ICD implant through 12-month follow-up and (ii) identify factors predictive of return to sexual activity and fears associated with sexual activity.MethodsThis secondary descriptive analysis was conducted with data from a randomized controlled trial (2009-2015) designed to compare 2 interventions for patients (Patient-Only) and for patients and their partners (Patient+Partner) after implant of an initial ICD. The sample included 105 patients and their intimate partners who reported sexual activity during the 24 months before ICD implant.OutcomesThe Sexual Concerns Inventory was used to assess sexual activity and related concerns.ResultsStudy participants comprised 72% male and were of mean age 65.6 ± 10.6 years; partners comprised 64% female and were of mean age 63 ± 11.6 years. Sexual activity increased after ICD: 73% of patients reported no sexual intercourse during 2 months before study enrollment, whereas only 46% reported no sexual intercourse during the 2 months before 12-month follow-up. Reductions in sexual concerns were evident 1 month after implant, with continued reductions through 12 months (patient 6.48 ± 4.03 to 5.22 ± 3.38, P = .004; partner 6.93 ± 4.01 to 5.2 ± 3.56, P < .001). Patient physical health predicted sexual activity 3 months after implant placement (P = .04); general ICD concerns (P < .001) predicted patient ICD-related sexual fears at 3 months. At 12 months, baseline general ICD concerns (P < .02) predicted sexual fears.Clinical implicationsICD patients and partners report low levels of sexual activity at the time of initial ICD implant, with reported increases in sexual activity over the 12-month recovery period: Sexual concerns were highest immediately after ICD implant.Strengths & limitationsNotably, the major strengths of this study were the repeated measures and longitudinal study design; the main limitation of the study was the lack of a "usual care" control group.ConclusionSexual activity at the time of an initial ICD implant is low, and sexual concerns are most prominent for both patients and partners immediately after implant placement. Baseline physical health predicts subsequent sexual activity at 3 months, while general ICD-related worry predicts sexual fears at 3 and 12 months. Streur MM, Rosman LA, Sears SF, et al. Patient and Partner Sexual Concerns During the First Year After an Implantable Cardioverter Defibrillator: A Secondary Analysis of the P+P Randomized Clinical Trial. J Sex Med 2020;17:892-902.

Dataset Information

Patient plus partner trial: A randomized controlled trial of 2 interventions to improve outcomes after an initial implantable cardioverter-defibrillator.

Background

Objective

Methods

Results

Conclusion

Publications

Patient plus partner trial: A randomized controlled trial of 2 interventions to improve outcomes after an initial implantable cardioverter-defibrillator.

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