A New Operation for the Treatment for Long-standing Atrial Fibrillation
Condition: Cardiovascular Disease
MeSH terms: Atrial Fibrillation; Cardiovascular Diseases
Study type: Interventional

Summary: 
      Atrial fibrillation(AF) often occurs in patients with mitral valve disease. Both mitral
      replacement and mitral valve plasty are the effective methods to the mitral valve disease.
      How to cure atrial fibrillation is the key to full recovery. Radiofrequency ablation (RFA) in
      surgery is an effective treatment for those patients. But there are some recurrence rate
      after RFA, particularly in patients with enlarged left atrium. So the investigators design a
      new procedure(Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and
      Left Appendage Base Closure) during mitral surgery and study the outcomes to evaluate this
      new operation.
    

Detailed description: 
      From September 2017, 20 selective patients, and then 120 consecutive patients with valvular
      atrial fibrillation were treated with our new operation. If the clinical results from the
      first 20 patients with restrict selection criteria are unsatisfied, that is, the restoration
      rate of the sinus rhythm was less than 50% at 1-year follow up, the study will be stopped.
      Otherwise, another single arm with 120 consecutive patients with valvular AF will be
      recruited for next phase.

      Procedure details: All patients will have their left atrial geometric volume reduced,
      pulmonary vein island isolated and left appendage ligated or suture closed. After the
      superior vena cava was transected, two circular incisions were usually made in the left
      atrial wall between the pulmonary veins and the mitral annulus for circumferential atrial
      strip resection and pulmonary vein island isolation. The first circular incision was
      performed around the pulmonary veins. With this incision, pulmonary vein island was isolated
      and the left atrium was opened. The second one was performed in the interatrial groove and
      extended around the mitral annulus, leaving a 2 cm inferior wall margin from the annulus and
      the appendage in situ. With those two incisions, a circumferential strip of the left atrium
      was excised. Then the base of the left atrial appendage was ligated or excised and sutured.
      After the mitral manipulations, the center of the pulmonary vein island was longitudinally
      reef-imbricated with a 3-0 polypropylene continuous running suture to exclude toward the
      outside of the left atrial cavity. This plicated pulmonary vein island was directly
      anastomosed to the resected margin around the mitral annulus and the intraatrial septum
      instead of the interatrial groove. Finally, caval continuity was restored after aortic
      cross-clamp removal using a running 4-0 polypropylene suture.

      Telephone contact was maintained with the patients after discharge.The use of antiarrhythmic
      medications will be allowed during the first 3 months(blanking period). Transthoracic
      2-dimensional echocardiography and Holter monitoring will be obtained at baseline and at 3,
      6, and 12 months after the initial operation. Whenever the participants have symptoms such as
      palpitation, dizziness, or shortness of breath, they could telephone the doctors.

      The primary efficacy endpoint is freedom from AF at both 6 months and 12 months after
      surgery, assessed by 7-days continuous Holter monitoring. The primary safety are
      cardiopulmonary bypass time; and a composite of death, stroke, serious cardiac events (heart
      failure, myocardial infarction), cardiac re-hospitalizations, transient ischemic attack,
      pulmonary embolism, peripheral embolism, coronary artery injury, anatomical excessive
      bleeding, deep sternal wound infection/mediastinitis, damage to specialized conduction system
      requiring permanent pacemaker, and superior vena cava stenosis, within 30 days after the
      procedure or hospital discharge (whichever was later) The secondary efficacy endpoint are the
      left atrial linear dimensions and A wave reappearance measured by transthoracic
      echocardiography at 3 time points (before surgery, 6 and 12 months after surgery). The
      secondary safety endpoint are Major adverse cardiac events, which were defined as a
      non-weighted composite score of: death, stroke, worsening heart failure (+1 NYHA Class),
      hospitalization for heart failure, and mitral valve re-intervention within 12 months after
      surgery; and incidence of protocol-defined serious adverse events (especially thromboembolic
      and hemorrhagic events) within 12 months after surgery. Statistical analysis were performed
      with statistic package for social science( SPSS) 11.5 software. A value of P < 0.05 was
      considered statistically significant.
    

Intervention name(s): Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure(selected patients); Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure
Intervention type(s): Procedure; Procedure
Intervention description(s): Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure; Left Atrial Geometric Volume Reduction, Pulmonary Vein Island Isolation and Left Appendage Base Closure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: atrial fibrillation; surgery