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The new Occlutech(®) patent ductus arteriosus occluder: Single centre experience
1Centre de Référence Malformations Cardiaques Congénitales Complexes (M3C), Necker Hospital for Sick Children, HEGP, Assistance publique-Hôpitaux de Paris, Paris, France; Université Paris Descartes, Sorbonne Paris Cité, Paris, France.
Insights
The Occlutech PDA occluder provides a safe and effective method for closing patent ductus arteriosus (PDA). This new device demonstrates comparable outcomes to existing transcatheter closure options.
Area of Science:
- Interventional Cardiology
- Pediatric Cardiology
- Medical Device Technology
Background:
- Transcatheter therapy is the primary treatment for patent ductus arteriosus (PDA) closure.
- Various devices have been utilized for PDA closure procedures.
Purpose of the Study:
- To evaluate the clinical experience with the novel Occlutech PDA occluder for PDA closure.
- Assess the safety and efficacy of this new device in a patient cohort.
Main Methods:
- A consecutive series of patients undergoing PDA closure with the Occlutech PDA occluder were studied.
- Implantation followed a standard technique, with post-procedural assessments including echocardiography.
- Systematic evaluation for residual shunting and complications like embolization or stenosis was performed.
Main Results:
- Fifty-six patients received the Occlutech PDA occluder, with successful closure achieved in most cases.
- Post-implantation angiography revealed residual shunting in a significant portion of patients, though most were moderate.
- One instance of device embolization occurred, requiring surgical retrieval; however, no device-related complications were noted at mid-term follow-up.
Conclusions:
- The Occlutech PDA occluder is a safe and effective option for transcatheter PDA closure.
- Its performance appears comparable to established devices currently available for PDA treatment.
Background:
Transcatheter therapy is the first-line treatment for closure of patent ductus arteriosus (PDA). A range of different devices have been used.
Aim:
To report our experience using the new Occlutech(®) PDA occluder for closure of PDA.
Methods:
All consecutive patients receiving an Occlutech(®) PDA occluder for closure of PDA from March 2014 to May 2015 were included in the study. Occluders were implanted using a conventional technique. After cardiac catheterization, transthoracic echocardiography was performed sequentially. Residual shunting and procedural and mid-term complications, including embolization, device-induced left pulmonary artery stenosis and aortic coarctation, were systematically assessed and reported.
Results:
Fifty-six patients (35 females) with a median age of 1 year (range: 29 days to 24 years) were included in the study. PDAs were closed successfully using device number 5/3.5 in 17 patients, 6/4 in 28 patients, 7/5 in four patients, 8/6 in six patients and 10/8 in one patient. Post-implantation angiography showed no residual shunt in 10 patients (17.8%), moderate intraprosthetic shunt in 43 patients (76.8%) and severe shunt in three patients (5.4%). One device embolized in the right pulmonary artery 1hour after successful closure; the device was retrieved surgically after unsuccessful snaring. After a mean follow-up of 10 months (range: 3-17.8 months), no residual shunt or device-related complications were noted.
Conclusion:
The new Occlutech(®) PDA occluder allows safe and efficient PDA closure, similar to existing devices.
