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

O’Callaghan, Barry; Zablah, Jenny E.; Vettukattil, Joseph J.; Levi, Daniel S.; Salem, Morris; Cabalka, Allison K.; Anderson, Jason H.; Ebeid, Makram R.; Alexy, Ryan; Morgan, Gareth J.

doi:10.32604/chd.2022.018590

Cited by 7 publications

(4 citation statements)

References 20 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The role of the devices among the patients in group 5 included fenestration reduction in two cases, fenestration occlusion in two cases, and fenestration creation in two cases. While the focus of our work is not on this subgroup in particular [e.g., similar to the work by O’Callaghan et al ( 17 )], we noted improvements in oxygen saturation and WHO FC at follow-up. While in the work by O'Callaghan, five of the six pediatric patients had failing Fontans, our cohort only included one patient with a failing Fontan.…”

Section: Discussionsupporting

confidence: 77%

A North American, single-center experience implanting fenestrated atrial devices and atrial flow regulators into a heterogeneous group of pediatric pulmonary hypertension patients

et al. 2023

View full text Add to dashboard Cite

IntroductionThe clinical deterioration commonly experienced by pediatric patients with pulmonary arterial hypertension (PAH) has motivated a shift in the treatment of pulmonary hypertension (PH) through innovations in surgical salvage interventions. The Occlutech fenestrated atrial septal defect (FASD) Occluder and the atrial flow regulator (AFR), which provides a protective, atrial-level shunt during hypertensive crises, have found an important role in treating pediatric patients with PAH. Other groups of pediatric patients with PH may also benefit from a similar protective physiology. The primary aim of this work is to present a single center's experience with AFR and FASD devices for managing a heterogeneous group of pediatric PH patients. A secondary goal is to identify hemodynamic changes and complications following device implantation.Materials and MethodsWe performed a retrospective review of all pediatric PH patients who, after being found suitable, either successfully or unsuccessfully received an FASD or AFR device between January 2015 and December 2021 at the Stollery Children's Hospital in Edmonton, Canada.ResultsFourteen patients (eight female) with a median age of 4.6 (range 0.3–17.9) years and a median body mass index of 15.1 (Q1 = 13.8, Q3 = 16.8) kg/m2 underwent device implantation: five received FASDs, eight received AFRs, and one was ultimately unable to receive an implant due to thrombosed iliac vessels and required surgical intervention. Of the fourteen patients, seven were in group 1 (PAH), one was in group 3 (lung disease), and six were in group 5 (primarily pulmonary hypertension vascular disease) under the World Symposium PH classification. All patients were on mono-, dual-, or triple-drug PH therapy. Device stabilization was not possible for two patients, who then required a repeat catheterization. Of the group 1 patients, three AFR and three FASD implants were successful, while one FASD implant was unsuccessful due to thrombosed vessels. At a six-month clinical assessment, all group 1 patients had patent devices and improved WHO FCs.ConclusionThis work presents a single center's experience with AFR and FASD implants in a heterogeneous group of fourteen pediatric patients with severe PH. This treatment strategy is novel in the pediatric population and so this work provides momentum for future studies of interventional cardiac catheterization procedures for pediatric patients with PH. Further collaborations are required to develop criteria to identify ideal pediatric candidates and optimally time interventions in order to maximize the benefits of this treatment.

show abstract

Section: Discussionsupporting

confidence: 77%

A North American, single-center experience implanting fenestrated atrial devices and atrial flow regulators into a heterogeneous group of pediatric pulmonary hypertension patients

et al. 2023

View full text Add to dashboard Cite

show abstract

“…In the pediatric population, some cases describe the safety and feasibility of the procedure in patients with PAH [ 38 ], Fontan’s failing circulation [ 39 , 40 ], and in young children [ 41 ]. In a recent multicenter US experience, AFR was implanted in six pediatric patients, five of whom had Fontan circulation failure and only one had left ventricular hypertension.…”

Section: Interventional Cardiologymentioning

confidence: 99%

“…All pediatric patients survived without complications. Oxygen saturations increased in all Fontan patients and were maintained through a follow-up of 8 weeks; also, NYHA class improved from a median of stage 3 before the procedure to a median of stage 2 after the procedure [ 39 ]. Currently, AFR in the pediatric population has been more frequently used for PAH and Fontan failure than heart failure compared to adults.…”

Section: Interventional Cardiologymentioning

confidence: 99%

Chronic Heart Failure in Children: State of the Art and New Perspectives

Castaldi

Cuppini

Fumanelli

et al. 2023

JCM

View full text Add to dashboard Cite

Pediatric heart failure (HF) is an important clinical condition with high morbidity and mortality. Compared to adults, pediatric HF shows different etiologies characterized by different physiology, a different clinical course, and deeply different therapeutic approaches. In the last few years, new drugs have been developed and new therapeutic strategies have been proposed with the goal of identifying an individualized treatment regimen. The aim of this article is to review the new potential drugs and non-pharmacological therapies for pediatric heart failure in children.

show abstract

“…It is available in 4, 6, 8, and 10 mm but only 8-and 10-mm devices have a CE Mark in adult patients with heart failure with preserved or reduced ejection fraction. Its off-label use with internal technical review by Occlutech has been described in patients with congenital heart disease (CHD), especially in children with Fontan palliation to create or reduce the size of the conduit fenestration, but also in patients with cardiomyopathy (6)(7)(8)(9)(10)(11)(12)(13)(14)(15). Finally, it has been successfully implanted in children on extracorporeal membrane oxygenator (ECMO) to unload the left cavities (16,17).…”

Section: Introductionmentioning

confidence: 99%

Implantation of atrial flow regulator devices in patients with congenital heart disease and children with severe pulmonary hypertension or cardiomyopathy—an international multicenter case series

Butera,

Piccinelli,

Kolesnik

et al. 2024

Front. Cardiovasc. Med.

View full text Add to dashboard Cite

BackgroundThe Occlutech Atrial Flow Regulator (AFR) is a self-expandable double-disc nitinol device with a central fenestration. Its use has been approved in the adult population with heart failure and described for pulmonary hypertension (PH). Only case reports and small series have been published about its use in the paediatric population and for congenital heart disease (CHD).ObjectivesThe authors sought to investigate the feasibility, safety, and short-term follow-up of AFR implantation in patients with CHD or children with PH or cardiomyopathy.MethodsThis is a multicenter retrospective study involving 10 centers worldwide. Patients of any age with CHD or patients aged < 18 years with PH or cardiomyopathy needing AFR implantation were included.ResultsA total of 40 patients underwent AFR implantation. The median age of the population at the time of the procedure was 58.5 months (IQR: 31.5–142.5) and the median weight was 17 kg (IQR: 10–46). A total of 26 (65.0%) patients had CHD, nine (22.5%) children, a cardiomyopathy, and five (12.5%), a structurally normal heart. The implantation success rate was 100%. There were two early and one late device thrombosis. Two patients (5.0%) with dilated cardiomyopathy on extracorporeal membrane oxygenator (ECMO) died during the hospital stay. At a median follow-up of 330 days (IQR: 125–593), 37 (92.5%) patients were alive. At follow-up, 20 patients improved their New York Heart Association (NYHA) class, 12 patients did not change their NYHA class, and one patient with idiopathic PH worsened.ConclusionsAFR implantation in patients with CHD and children with severe PH or cardiomyopathy is promising and seems to have beneficial effects at short-term follow-up.

show abstract

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

Cited by 7 publications

References 20 publications

A North American, single-center experience implanting fenestrated atrial devices and atrial flow regulators into a heterogeneous group of pediatric pulmonary hypertension patients

A North American, single-center experience implanting fenestrated atrial devices and atrial flow regulators into a heterogeneous group of pediatric pulmonary hypertension patients

Chronic Heart Failure in Children: State of the Art and New Perspectives

Implantation of atrial flow regulator devices in patients with congenital heart disease and children with severe pulmonary hypertension or cardiomyopathy—an international multicenter case series

Contact Info

Product

Resources

About