Echocardiography-guided Percutaneous Patent Ductus Arteriosus Closure
Condition: Echocardiography; PDA
MeSH terms: Ductus Arteriosus, Patent
Study type: Observational [Patient Registry]

Summary: 
      Since the first successful percutaneous closure under transoesophageal echocardiographic
      (TEE) guidance, many centres explored transcatheter procedures without fluoroscopy. This
      single centre study aims to show the feasibility and safety of percutaneous patent ductus
      arteriosus (PDA) closure under echocardiography-only guidance during our one-year experience.
      Patients with PDA were recruited for percutaneous PDA closure guided by either fluoroscopy or
      echocardiography-only in National Cardiovascular Center Harapan Kita. Patients were evaluated
      clinically and radiologically using TTE at 6, 24 and 48 hours after the procedure. Primary
      endpoint was the procedural success. Secondary endpoints were the procedural time and the
      rate of adverse events. Echocardiography-guided PDA closure is non-inferior to
      fluoroscopy-guided PDA closure, with similar procedural times. However, this method is
      operator-dependent and requires an experienced team for it to be performed successfully.
    

Detailed description: 
      From March 2019 to April 2020, a total of 60 patients with PDA were recruited as participants
      for this prospective, single-centre, non-randomized clinical trial. They were divided equally
      into two groups: the fluoroscopy group who underwent percutaneous PDA guided by fluoroscopy
      and the echocardiography group who underwent percutaneous PDA closures guided by
      transthoracic echocardiography (TTE) and TEE at the National Cardiovascular Centre Harapan
      Kita, Jakarta, Indonesia. Patients with stable hemodynamic and clinically asymptomatic PDA
      were evaluated and considered for transcatheter PDA closure. Significant chamber enlargement
      and mild to moderate pulmonary hypertension were also indications for transcatheter closure.
      Ductal morphology was evaluated using multiplanar TTE and TEE imaging.

      After the procedures, patients were evaluated and followed-up after 6, 24 and 48 hours to
      observe any residual shunts and complications. This study protocol conforms to the ethical
      guidelines of the Declaration of Helsinki and the Nuremberg Code with approval from the
      Research Ethics Committee of National Cardiovascular Center Harapan Kita No
      LB.02.01/VII/475/KEP076/2020. Written consent to perform the procedure and to use the
      patients' medical records for this study was obtained from the patients or their parents.
    

Intervention name(s): Echocardiography guide
Intervention type(s): Other
Intervention description(s): Patients with PDA are percutaneously closed with echocardiography guide, without fluoroscopy like classical procedures
Observational model: Case-Crossover
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        The inclusion criteria for this study are children under 18 years old with PDA who were
        planned for PDA closure. The exclusion criteria include the coexistence of other associated
        congenital heart disease requiring surgical intervention and PDA patients with irreversible
        high pulmonary vascular resistance (PVR) unreactive with the oxygen test.
      
Keywords: Patent Ductus Arteriosus (PDA); Transcatheter closure; Without fluoroscopy; echocardiography