Medical Economical Evaluation of the Ablation by Catheter of the Atrial Tissue in the Treatment of AF
Condition: Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Observational

Summary: 
      The atrial fibrillation is the most frequent confusions of the heart rhythm: his preValencia
      increases with the age, and the investigators consider that beyond 65 years, 5 % of the
      population is affected by this arrhythmia. It entails a greater risk of morbidity
      (thromboembolic accident and cardiac insufficiency) and of cardiovascular mortality
      (mortality increased by a factor 1,7 - 2) independents of the causal pathology or the
      associated risk factors. For all these reasons, it raises a real problem of public health.
    

Detailed description: 
      The atrial fibrillation is the most frequent confusions of the heart rhythm: his preValencia
      increases with the age, and we consider that beyond 65 years, 5 % of the population is
      affected by this arrhythmia. It entails a greater risk of morbidity (thromboembolic accident
      and cardiac insufficiency) and of cardiovascular mortality (mortality increased by a factor
      1,7 - 2) independents of the causal pathology or the associated risk factors. For all these
      reasons, it raises a real problem of public health.

      The medical treatment of PAROXYSTIC or persistent atrial fibrillation associates
      antiarrythmic and anticoagulant. The purpose of it is to maintain the sinusal rhythm and to
      prevent the thromboembolic complications. The success rate of the treatment antiarrythmic is
      disappointing, not exceeding, on average, 50 % with 1 year. In addition the incidence of the
      side effects of these molecules as that of the anticoagulants is far from being negligible.

      Other not-pharmacological therapeutic alternatives were proposed among resistant patients,
      such final cardiac stimulation whose results are not currently very convincing. Ablation by
      catheter is, except the surgery whose indications are exceptional, the only curative
      treatment of AF. The complications of the procedure are rare (1 to 2%), but they can be
      severe. The indication of ablation for which there is currently a consensus is that of AF
      PAROXYSTIC repeating or persistent, symptomatic, on c?ur normal or pathological, resistant to
      at least 1 major treatment antiarrythmic. The effectiveness of ablation was validated by many
      studies within the framework of PAROXYSTIC or persistent AF in very specialized centers. The
      diffusion of this mode of treatment is limited in our country where very few centers practise
      it because of a long and difficult training of the technique, claiming a great expertise, but
      also of the need for human and material means important. The number of ablations carried out
      in the consensual indications in 2003 in France was approximately 450. This figure is very
      weak compared to the prevalence of this disorder of the rate/rhythm. This leads in the few
      centers invested to long withdrawal periods for the patient whom can reach 4 to 12 months.

      Awaited benefit of ablation by catheter:

        1. reduction of the costs of health thanks to the suppression of any treatment and with a
           reduction of the duration and frequency of the hospitalizations and consultations

        2. faster rehabilitation of the patients in the active life.

      Principal objectives of this evaluation: medical and economic:

        1. medical evaluation of the effectiveness of ablation by radio frequency of AF under
           conditions of real practice: persistence of the sinusal rhythm. Ablation should make it
           possible to cure 70 % of the treated patients

        2. costing of the technique and utilization of the results expressed in avoided costs,
           reduction of the stops of work and quality of life, compared with those of the medical
           treatment studied retrospectively on 1 year.

      Secondary objectives:

        1. evaluation of the risk of ablation: complications related to the procedure and inherent
           with the treated arrhythmia,

        2. evaluation of the quality of life of the treated patients: use of antiarrythmic, the
           anticoagulants, questionnaires of quality of life: SF 36, professional renewal of
           activity

        3. analysis of the impact of the setting in?uvre of the technique of ablation on the system
           of care of the various hospital complexes concerned

        4. exploratory study of determination of the criteria of success/failure of ablation.

      Method:

      national, prospective, comprising 1 year of inclusion and 2ans of follow-up but also
      retrospective multicentric evaluation over the year preceding ablation, each patient
      constituting his own witness. Considering an assumption of success awaited of ablation of
      about 70 %, the number of patients included on 1 year will have to be 225 in order to obtain
      a precision about ± 6 % in the determination of the success rate of the method under
      conditions of real practice. In addition this size of sample will allow an analysis of the
      various medico-economic criteria and the construction of a multivariate model of prediction
      of the success of ablation according to the characteristics of the patients. It was checked
      that this size of sample was perfectly possible taking into account current flows of
      patients.

      Criteria of inclusion:

      old patients from 18 to 80 years presenting F PAROXYSTIC or persistent, symptomatic,
      documented (at least 1 episode documented by ECG and/or Holter) and dating of more than 6
      months, having repeated under at least 1 major anti-asynchronous treatment.

      Awaited results and prospects:

      this project will make it possible to appreciate the médico-economic impact of this
      therapeutic among patients presenting an allowed indication of ablation. It will provide the
      essential information and never yet collected in France on such a scale. It will make it
      possible to develop this activity at the hospital level, essential condition with its
      development. It will also make it possible to appreciate the operational constraints in term
      of need for teams and their distribution on the territory taking into account flows of
      patients and the level for necessary technicality. This study will finally make it possible
      to determine the predictive elements of therapeutic success and to which type of patients
      ablation brings the greatest benefit.
    

Intervention name(s): Ablation of atrial fibrillation
Intervention type(s): Procedure
Intervention description(s): Ablation of atrial fibrillation
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Description of the patients experiencing a first AF ablation
      
Keywords: Atrial fibrillation; Ablation