Clinical trial NCT01019759: The Value of add-on Arrhythmia Surgery in Patients With Atrial Fibrillation Undergoing Cardiac Surgery
Official title: The Value of add-on Arrhythmia Surgery in Patients With Paroxysmal or Persistent Atrial Fibrillation Undergoing Valvular or Coronary Bypass Surgery. A Randomised Comparison on Quality of Life, Cost-effectiveness, Morbidity and Rhythm Outcome.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
cardiac surgery
ablation
pulmonary veins
Lead sponsor: Maastricht University Medical Center
Sponsor class: OTHER
First posted: 2009-11-25
Enrollment: 150
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The hypothesis being studied is that add-on arrhythmia surgery in patients with atrial fibrillation (AF) undergoing valvular or coronary surgery improves quality of life, is cost-effective, reduces perioperative and long-term morbidity associated with AF.

Detailed description: 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 we do not know whether add-on arrhythmia surgery indeed affects morbidity and quality of life. In this respect the benefit of chronic sinus rhythm has to outweigh the risks of a prolonged operation. In addition, cardiovascular complaints unrelated to AF may persist even after successful operation, thus offsetting the benefit of chronic sinus rhythm. Add-on surgery is more costly than standard surgery but this may compare favourably with shorter hospital admission due to less frequent post-operative AF.

Valvular heart disease is frequently associated with ventricular remodelling: a decreased ventricular function and atrial dilatation. AF itself may worsen heart failure due to a tachycardiomyopathy. Elimination of AF might therefore enhance recovery from structural and functional remodelling and promote recovery of quality of life after the operation.

The PIAF, RACE and AFFIRM have shown that chronic sinus rhythm is not necessarily associated with a reduced morbidity or enhanced quality of life. PIAF however showed that exercise tolerance was better when rhythm control was achieved. Further analyses of RACE and AFFIRM are pending. One drawback of the above studies is the fact that chronic sinus rhythm is difficult to obtain. In PIAF, RACE and AFFIRM only 30 to 50% was in sinus rhythm at the end of follow-up. By contrast, arrhythmia surgery is a highly effective treatment in this respect.

Forty patients underwent a (phase 1-study) coronary bypass- or valve surgery with add-on arrhythmia surgery in the same way as in this protocol proposed. This means epicardial on beating heart and without use of the heart-lung machine. In the last follow-up 80 % of the patients not longer were in atrial fibrillation. With similar treatment procedures, but more invasive, so on the arrested heart and endo cardially, success percentages reported varying from 60 % till 80%.

This large variance in success rate is probably related to the primary course of the disease and the degree of the morphological abnormality. In spite of these meaningful results ''add-on'' arrhythmia surgery is no general accepted treatment. The intended patient population remains generally untreated. Historical data of patients from the university hospital of Maastricht show that no add on treatment has a success rate of 25% of patients in sinus rhythm.

Considering the above a randomised comparison of add-on arrhythmia surgery and standard surgery is warranted.

Eligibility criteria: Inclusion Criteria:

1. Patients undergo valvular surgery, coronary surgery, or a combination of both.
2. All patients have documented chronic atrial fibrillation of paroxysmal atrial fibrillation.
3. Patients have given written informed consent.

Exclusion Criteria:

1. Patients who do not speak Dutch or can not read Dutch.
2. Patients with a Sick Sinus Syndrome.
3. Patients with contraindications for oral anticoagulant agents.
4. Patients unable to express their specific wishes.

Primary outcomes:
measure: Percentage of patients free from atrial fibrillation, as apparent from 24 hour Holter registration, in addition to standard ECG. For the purpose of this primary endpoint, AF was defined as lasting longer than 10 seconds.
timeFrame: between 3 months and 12 months post-operative
Secondary outcomes:
measure: Quality of life (QoL)
timeFrame: at 3, 6 and12 months post-operative
measure: Cost-effectiveness
timeFrame: intraoperative untill 12 months post-operative
measure: In-hospital morbidity (incl. pulmonary complications, resternotomy for surgical bleeding, cerebrovascular accidents, acute myocardial infarction, renal failure, development of atrioventricular conduction abnormalities)
timeFrame: post-operative, in-hospital period
measure: Rhythm related events and interventions (incl. electrical or chemical cardioversion, percutaneous catheter ablation, implantation of a defibrillator, pacemaker implantation)
timeFrame: discharge untill 12 months post-operative
measure: Out-of-hospital morbidity (incl. acute myocardial infarction, percutaneous catheter ablation, implantation of a defibrillator, pacemaker implantation and cerebrovascular accidents, syncope)
timeFrame: discharge untill 12 months post-operative
measure: Mortality
timeFrame: intraoperative untill 12 months post-operative
Other outcomes:
Locations:
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Center
state: Limburg
Study officials:
affiliation: dept. Cardiothoracic Surgery, University hospital of Maastricht
name: Jos G Maessen,, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: