Health-related quality of life relative to clinical outcomes in patients with atrial fibrillation treated with ventricular rate stabilisation pacing.

AIMS: It is uncertain whether patient perception of atrial fibrillation (AF) is based on the fast ventricular rate as such or the irregularity of the ventricular responses. This trial was designed to confirm the effectiveness of a ventricular rate stabilisation (VRS) algorithm in reducing ventricular irregularity during permanent pacing in patients with AF and to assess the patient preference and effect on quality of life (QoL).
METHODS: In this multicentre single-blind randomised crossover trial, 184 patients with drug-refractory permanent (n=91) or paroxysmal (n=93) AF received a VVI(R) or DDD(R) pacemaker respectively and were paced in a randomised sequence with VRS on or off for two months. Clinical assessments (QoL, New York Heart Association (NYHA) classification, echocardiography, six-minute walk test and Holter recording) were carried out at baseline, at randomisation and after each crossover period. QoL assessment was performed using Aquarel, a new disease-specific QoL questionnaire for pacemaker patients, the Short Form 36 survey (SF-36), the Duke Activity Status Index (DASI) and the Symptom Checklist frequency and severity scores. At the end of the study patients preferences for VRS-on or VRS-off were recorded.
RESULTS: VRS pacing reduced ventricular irregularity without increasing the mean ventricular rate. VRS-on was preferred by 65.8% of patients with paroxysmal AF; patients with permanent AF had no preference. QoL did not show improvement during VRS pacing on any of the instruments.
CONCLUSION: VRS pacing is effective in reducing ventricular rhythm irregularity. QoL does not improve during VRS pacing but preference for VRS pacing appears particularly outspoken for patients with paroxysmal AF.

RCT Entities:   Population Interventions Outcomes