The Effect of Arrhythmia Surgery on Quality of Life in Patients With Atrial Fibrillation Undergoing Cardiac Surgery

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Procedure: Pulmonary vein isolation using microwave energy

Study type: Interventional

Funder types: Other

Identifiers

NCT00886080

PF 178

Details and patient eligibility

About

Atrial fibrillation (AF) is connected with an increased morbidity and mortality. In addition, quality of life is diminished due to palpitations, dyspnea, dizziness and syncope. AF is frequently associated with valvular and coronary disease. In the AF patients undergoing valvular or coronary surgery the arrhythmia almost always relapses. For symptom control anti-arrhythmic drugs and cardioversion are used but breakthrough arrhythmias and side effects of the drugs happen frequently. For more effective symptom control "add-on" arrhythmia surgery is being advocated. However, at present the investigators do not know whether add-on arrhythmia surgery indeed affects morbidity and quality of life.

The hypothesis being studied is that add-on arrhythmia surgery in patients with AF undergoing valvular or coronary surgery improves quality of life, establishes chronic sinus rhythm and reduces perioperative and long-term morbidity associated with AF.

Full description

Multicentre prospective parallel randomised controlled trial. In total 150 patients with documented atrial fibrillation (chronic and paroxysmal), were randomly assigned by a central computer system to undergo cardiac surgery with add-on surgery or without. This assignment was blinded to patients and all medical personnel except for the surgical team during total follow up. Patients completed quality of life questionnaires, comprising the RAND 36-item Health Survey 1.0 (SF-36), Multidimensional Fatigue Inventory-20 (MFI-20) and EuroQoL (EQ-5D and VAS) at baseline and 3, 6 and 12 months following operation.

Enrollment: 150 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergo valvular surgery and/ or coronary surgery,
• All patients have documented chronic atrial fibrillation of paroxysmal atrial fibrillation.
• Patients have given written informed consent.

Exclusion criteria

• Patients who do not speak Dutch or can not read Dutch.
• Patients with a Sick Sinus Syndrome.
• Patients with contraindications for oral anticoagulant agents.
• Incompetent to act for oneself

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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150 participants in 1 patient group

Add-on arrhythmia surgery

Experimental group

Description:

Adjuvant anti-arrhythmic surgery consists of a beating heart epicardial "box" isolation of all pulmonary veins using microwave energy (Flex 4 or Flex 10 ablation probes and Microwave generator by Guidant/Afix, Fremont, CA, USA). The surgical ablation procedure is the first step during surgery and is performed before institution of cardiopulmonary bypass allowing off-pump beating heart ablation. In addition excision or exclusion of the left atrial appendage is performed in both the treated as the control group.

Treatment:

Procedure: Pulmonary vein isolation using microwave energy