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Multi-Institutional US Experience of the Occlutech© AFR Device in Congenital and Acquired Heart Disease

Barry O’Callaghan1, Jenny Zablah1, Joseph Vettukattil2, Daniel Levi3,4, Morris Salem4, Allison Cabalka5, Jason Anderson6, Makram Ebeid6, Ryan Alexy7, Gareth J. Morgan1,*

1 The Heart Institute, Children’s Hospital Colorado, Aurora, USA
2 Pediatric Cardiology, Helen DeVos Children’s Hospital, Grand Rapids, USA
3 Pediatric Cardiology, UCLA Health, Mattel Children’s Hospital, Los Angeles, USA
4 Pediatric Cardiology, UCLA Medical Centre, Los Angeles, USA
5 Pediatric Cardiology, Mayo Clinic, Rochester, USA
6 Pediatric Cardiology, University of Mississippi Medical Center, Jackson, USA
7 Pediatric Cardiology, Riley Hospital for Children at Indiana University Health, Indianapolis, USA

* Corresponding Author: Gareth J. Morgan. Email: email

Congenital Heart Disease 2022, 17(1), 107-116.


Objectives: To detail the US multi-institutional experience with the Occlutech© (Occlutech International AB, Helsingborg, Sweden) atrial flow regulator (AFR) in children and adults with acquired or congenital heart disease. Background: The creation of a long-term atrial communication is desirable in several cardiovascular disease phenotypes, most notably pulmonary arterial hypertension, disorders of increased left ventricular filling and increased cavopulmonary pressures in patients with a Fontan type circulation. Methods: Patients were identified for inclusion from the AFR device manufacturer database. Data was collected using a RedCap database following IRB approval. 8 weeks of follow up data was sought for each patient based on available data. Data was analyzed and summarized using SPSS. Results: We report the experience of 6 US centers in the implantation of AFR devices in 15 patients, across a wide age range, with different disease phenotypes and a variety of indications. Implantation was technically successful in all patients and improvement was noted in both clinical and hemodynamic parameters. There were no immediate or intermediate term complications reported. 3 patients died remote from implantation. Their deaths were not felt to be related to the AFR device or related procedural complications. Conclusion: Compassionate use of the AFR device in children and adults with congenital & acquired heart disease is technically feasible and produces beneficial short term hemodynamic and symptomatic improvement. Widespread uptake of this technique and treatment at specialist centers has the potential to provide significant benefits to a variety of complex patients with currently limited treatment options and indeterminate prognosis.


Cite This Article

O’Callaghan, B., Zablah, J., Vettukattil, J., Levi, D., Salem, M. et al. (2022). Multi-Institutional US Experience of the Occlutech© AFR Device in Congenital and Acquired Heart Disease. Congenital Heart Disease, 17(1), 107–116.

cc This work is licensed under a Creative Commons Attribution 4.0 International License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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