Stable Longitudinal Quality of Life in the SERVE Trial Among Adults With Transposition of the Great Arteries and a Systemic Right Ventricle

Alessandro Castiglione MD , Markus Schwerzmann MD , Judith Bouchardy MD , Ronny Ralf Buechel MD , Reto Engel MD , Michael Freese MD , Harald Gabriel MD , Matthias Greutmann MD , Dik Heg PhD , Christian Mueller MD , Mathias Possner MD , Francisco Javier Ruperti-Repilado MD , Tobias Rutz MD , Jurg Schwitter MD , Corina Thomet PhD , Daniel Tobler MD , Matthias Wilhelm MD , Kerstin Wustmann MD , Fabienne Schwitz MD , SERVE trial
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Abstract

Background

Adults with a transposition anatomy and a systemic right ventricle (RV) face long-term complications that may impact their quality of life (QoL). Few data are available regarding the QoL in this patient group and its evolution over time.

Methods

This study was performed in the SERVE trial’s (identifier: NCT03049540) prospective cohort of patients (n = 100) with congenitally corrected transposition of the great arteries (TGA) or dextro-TGA after the atrial switch procedure and a longitudinal follow-up of 3 years. We aimed to describe the longitudinal QoL levels and their predictors. QoL was assessed using the Linear Analog Scale. QoL parameters were collected at baseline, after 12 months, and after 36 months, together with clinical parameters and a questionnaire assessing general self-efficacy (GSE).

Results

The mean QoL on the Linear Analog Scale was 79.1 ± 13.6 at baseline, 75.5 ± 14.8 at 1 year, and 79.2 ± 13.6 at 3-year follow-up (P = 0.900). No significant differences in QoL were observed between congenitally corrected TGA or dextro-TGA patients. Cardiopulmonary exercise testing maximum work rate and maximum oxygen uptake, New York Heart Association class, end-diastolic RV volumes, N-terminal pro–B-type natriuretic peptide concentration, and GSE showed significant correlations with QoL levels. Multivariable regression analysis identified GSE value and New York Heart Association class (r2 = 0.283, P < 0.001) as independent predictors of QoL at baseline.

Conclusions

Patients with a systemic RV reported a stable good QoL during 3 years of follow-up. Exercise capacity and self-efficacy were the only independent predictors of QoL.

Clinical Trial Registration

NCT03049540.

Abstract Image

在成人大动脉转位和系统性右心室的SERVE试验中稳定的纵向生活质量
背景:患有转位解剖和系统性右心室(RV)的成年人面临可能影响其生活质量(QoL)的长期并发症。关于该患者组的生活质量及其随时间变化的数据很少。方法:本研究是在SERVE试验(识别码:NCT03049540)的前瞻性队列中进行的,该队列患者(n = 100)在心房开关手术后先天性纠正性大动脉转位(TGA)或右旋TGA,并进行了3年的纵向随访。我们的目的是描述纵向生活质量水平及其预测因子。生活质量采用线性模拟量表评估。在基线、12个月后和36个月后收集生活质量参数,以及临床参数和评估一般自我效能感的问卷。结果基线时平均生活质量为79.1±13.6,随访1年为75.5±14.8,随访3年为79.2±13.6 (P = 0.900)。先天性矫正TGA与右旋TGA患者的生活质量无显著差异。心肺运动试验最大工作速率和最大摄氧量、纽约心脏协会分级、舒张末期RV容积、n端前b型利钠肽浓度、GSE与QoL水平有显著相关性。多变量回归分析确定GSE值与纽约心脏协会分类(r2 = 0.283, P <;0.001)作为基线生活质量的独立预测因子。结论系统性RV患者在3年随访期间的生活质量稳定良好。运动能力和自我效能是生活质量的独立预测因子。临床试验注册号:nct03049540。
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