Implantation of the Medtronic Harmony Transcatheter Pulmonary Valve Improves Right Ventricular Size and Function in an Ovine Model of Postoperative Chronic Pulmonary Insufficiency

Schoonbeek, Rosanne C.; Takebayashi, Satoshi; Aoki, Chikashi; Shimaoka, Toru; Harris, Matthew A.; Fu, Gregory L.; Kim, Timothy S.; Dori, Yoav; McGarvey, Jeremy R.; Litt, Harold; Bouma, Wobbe; Zsido, Gerald A; Glatz, Andrew C.; Rome, Jonathan J.; Gorman, Robert C.; Gorman, Joseph H.; Gillespie, Matthew J.

doi:10.1161/circinterventions.116.003920

Cited by 21 publications

(18 citation statements)

References 29 publications

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“…(14) Medtronic's new Harmony valve promises to extend that spectrum even further, allowing treatment of much larger RVOT diameters (Figure 7). (37) …”

Section: Indications For Surgical and Transcatheter Pulmonary Valve Rmentioning

confidence: 99%

The management of tetralogy of Fallot after corrective surgery

Tretter

Morello

Chaudry

et al. 2018

SAHJ

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“…(14) Medtronic's new Harmony valve promises to extend that spectrum even further, allowing treatment of much larger RVOT diameters (Figure 7). (37) …”

Section: Indications For Surgical and Transcatheter Pulmonary Valve Rmentioning

confidence: 99%

The management of tetralogy of Fallot after corrective surgery

Tretter

Morello

Chaudry

et al. 2018

SAHJ

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“…Further research and development of designs based on this model are under way. The Harmony valve (Medtronic)74), Venus P-valve (Venus Medtech, Shanghai, China)75,76), and Edwards SAPIEN XT valve (Edwards Lifesciences, Irvine, CA, USA)77) were developed and have been used clinically for patients with a large (>22 mm) RVOT (Fig. 2).…”

Section: Dilatationmentioning

confidence: 99%

Recent advances in pediatric interventional cardiology

Kim

2017

Korean J Pediatr

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During the last 10 years, there have been major technological achievements in pediatric interventional cardiology. In addition, there have been several advances in cardiac imaging, especially in 3-dimensional imaging of echocardiography, computed tomography, magnetic resonance imaging, and cineangiography. Therefore, more types of congenital heart diseases can be treated in the cardiac catheter laboratory today than ever before. Furthermore, lesions previously considered resistant to interventional therapies can now be managed with high success rates. The hybrid approach has enabled the overcoming of limitations inherent to percutaneous access, expanding the application of endovascular therapies as adjunct to surgical interventions to improve patient outcomes and minimize invasiveness. Percutaneous pulmonary valve implantation has become a successful alternative therapy. However, most of the current recommendations about pediatric cardiac interventions (including class I recommendations) refer to off-label use of devices, because it is difficult to study the safety and efficacy of catheterization and transcatheter therapy in pediatric cardiac patients. This difficulty arises from the challenge of identifying a control population and the relatively small number of pediatric patients with congenital heart disease. Nevertheless, the pediatric interventional cardiology community has continued to develop less invasive solutions for congenital heart defects to minimize the need for open heart surgery and optimize overall outcomes. In this review, various interventional procedures in patients with congenital heart disease are explored.

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“…Pulmonary insufficiency is a consequence of transannular patch repair in Tetralogy of Fallot (ToF) leading to right ventricular dilation, ventricular arrhythmias and heart failure . Pulmonary valve replacement (PVR), traditionally with a surgically implanted bioprosthetic valve, can prevent or ameliorate some of these long term complications .…”

Section: Introductionmentioning

confidence: 99%

“…In patients with a failing right ventricle‐to‐pulmonary artery (RV‐PA) conduit or surgical bioprosthetic valve, transcatheter PVR (TPVR) with balloon‐expandable bioprosthetic valves has become increasingly common . Follow‐up of these devices has shown promising results while avoiding the risks and complications of surgical valve replacement . The off‐label use of Melody (Medtronic, Minneapolis, MN) and Sapien (Edwards Lifesciences, Inc.) TPV in “native” right ventricular outflow tracts (RVOTs) has also been described, but is limited due to the typically dilated and heterogeneous shape of the native RVOT following transannular patch repair …”

Section: Introductionmentioning

confidence: 99%

“…The limited applicability of balloon expandable valves within these complex outflow tracts has fueled the development of self‐expanding valve platforms designed to conform to a variety of native RVOT shapes and sizes . Implantation of a self‐expanding stent valve was described by Bonhoeffer and colleagues in 2009, and work since that time has resulted in the development of the Harmony TPV (Medtronic, Minneapolis, MN) which has been studied in both preclinical models, and in early human trials . These studies have demonstrated encouraging improvements in ventricular size and function after TPVR .…”

Section: Introductionmentioning

confidence: 99%

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Toward predictive modeling of catheter‐based pulmonary valve replacement into native right ventricular outflow tracts

Jolley

Lassó

Nam

et al. 2018

Cathet Cardio Intervent

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Background Pulmonary insufficiency is a consequence of transannular patch repair in Tetralogy of Fallot (ToF) leading to late morbidity and mortality. Transcatheter native outflow tract pulmonary valve replacement has become a reality. However, predicting a secure, atraumatic implantation of a catheter‐based device remains a significant challenge due to the complex and dynamic nature of the right ventricular outflow tract (RVOT). We sought to quantify the differences in compression and volume for actual implants, and those predicted by pre‐implant modeling. Methods We used custom software to interactively place virtual transcatheter pulmonary valves (TPVs) into RVOT models created from pre‐implant and post Harmony valve implant CT scans of 5 ovine surgical models of TOF to quantify and visualize device volume and compression. Results Virtual device placement visually mimicked actual device placement and allowed for quantification of device volume and radius. On average, simulated proximal and distal device volumes and compression did not vary statistically throughout the cardiac cycle (P = 0.11) but assessment was limited by small sample size. In comparison to actual implants, there was no significant pairwise difference in the proximal third of the device (P > 0.80), but the simulated distal device volume was significantly underestimated relative to actual device implant volume (P = 0.06). Conclusions This study demonstrates that pre‐implant modeling which assumes a rigid vessel wall may not accurately predict the degree of distal RVOT expansion following actual device placement. We suggest the potential for virtual modeling of TPVR to be a useful adjunct to procedural planning, but further development is needed.

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Implantation of the Medtronic Harmony Transcatheter Pulmonary Valve Improves Right Ventricular Size and Function in an Ovine Model of Postoperative Chronic Pulmonary Insufficiency

Cited by 21 publications

References 29 publications

The management of tetralogy of Fallot after corrective surgery

The management of tetralogy of Fallot after corrective surgery

Recent advances in pediatric interventional cardiology

Toward predictive modeling of catheter‐based pulmonary valve replacement into native right ventricular outflow tracts

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