Abstract
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.
Highlights
The atrial flow regulator device (AFR) by Occlutech © was designed primarily to treat adult patients with symptomatic heart failure, with both preserved and reduced ejection fraction
Current life expectancy for patients with pulmonary arterial hypertension, with or without congenital heart disease (CHD) is limited and this is confounded by a scarcity of pharmacological and procedural interventions available to treat those with advanced disease
3.1 Demographics, Clinical and Procedural Data AFR implantation was successfully completed in 15 consecutive patients at 6 centers. 1 center carried out 6 implantations, 1 center carried out 3 implantations, 3 centers carried out 2 implantations and 1 center carried out 1 implantation
Summary
The atrial flow regulator device (AFR) by Occlutech © was designed primarily to treat adult patients with symptomatic heart failure, with both preserved and reduced ejection fraction. The introduction of the AFR has generated interest from the congenital cardiology community, dealing with pediatric and adult patients with congenital and acquired heart disease as well as pulmonary arterial hypertension (PH). The increasing survival of CHD patients has led to an increasing complexity of disease substrate requiring treatment [1,2]. An example of this is those patients surviving with complex Fontan physiology. Treatment options here are limited in both number and efficacy [3]
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