Echocardiography-guided Percutaneous Patent Ductus Arteriosus Closure

Echocardiography-guided Percutaneous Patent Ductus Arteriosus Closure: A One-Year Single Centre Experience in Indonesia

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.

Study Overview

• Status: Completed
• Conditions: Echocardiography; PDA
• Intervention / Treatment: Other: Echocardiography guide

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.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta, Indonesia, 11420
    • National Cardiovascular Center Harapan Kita Jakarta Indonesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• PDA, age <= 18yo

Exclusion Criteria:

• >= 18yo, Eisenmenger syndrome, coexistence of other associated congenital heart disease

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Use Fluoroscopy (Control); PDA closure in 30 patients with fluoroscopy guide
No fluoroscopy (test); PDA closure in 30 patients with echocardiography guide, without fluoroscopy	Other: Echocardiography guide; Patients with PDA are percutaneously closed with echocardiography guide, without fluoroscopy like classical procedures

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of Residual Shunt from post-procedure to 6 hours, 24 hours and 48 hours	PDA residual shunt post PDA closure	6, 24 hours, and 48 hours
Change of Device Position from post-procedure to 6 hours, 24 hours and 48 hours	If device dislodge during follow-up	6, 24 hours, and 48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedural time	Time total needed to complete procedure	6hours
Complication	if any death, peripheral vascular injury, pericardial effusion, pericardial tamponade	6, 24hours, and 48hours

Collaborators and Investigators

• Sponsor: National Cardiovascular Center Harapan Kita Hospital Indonesia
• Investigators: Principal Investigator: Sisca N Siagian, MD, National CCHK

Publications and helpful links

General Publications

• Siagian SN, Prakoso R, Putra BE, Kurniawati Y, Lelya O, Sembiring AA, Atmosudigdo IS, Roebiono PS, Rahajoe AU, Harimurti GM, Mendel B, Christianto C, Setiawan M, Lilyasari O. Echocardiography-Guided Percutaneous Patent Ductus Arteriosus Closure: 1-Year Single Center Experience in Indonesia. Front Cardiovasc Med. 2022 May 23;9:885140. doi: 10.3389/fcvm.2022.885140. eCollection 2022.

Study record dates

Study Major Dates

• Study Start (Actual): March 12, 2019
• Primary Completion (Actual): June 23, 2020
• Study Completion (Actual): June 23, 2020

Study Registration Dates

• First Submitted: March 22, 2022
• First Submitted That Met QC Criteria: April 4, 2022
• First Posted (Actual): April 11, 2022

Study Record Updates

• Last Update Posted (Actual): April 11, 2022
• Last Update Submitted That Met QC Criteria: April 4, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: echocardiography; Transcatheter closure; Patent Ductus Arteriosus (PDA); Without fluoroscopy
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Congenital Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Ductus Arteriosus, Patent
• Other Study ID Numbers: LB.02.01/VII/475/KEP076/

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: At the moment, we have no plan to share the whole participant data. However, if it is needed, we will.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No