Implantation of the Medtronic Harmony Transcatheter Pulmonary Valve Improves Right Ventricular Size and Function in an Ovine Model of Postoperative Chronic Pulmonary Insufficiency.
BACKGROUND
Pulmonary insufficiency is the nexus of late morbidity and mortality after transannular patch repair of tetralogy of Fallot. This study aimed to establish the feasibility of implantation of the novel Medtronic Harmony transcatheter pulmonary valve (hTPV) and to assess its effect on pulmonary insufficiency and ventricular function in an ovine model of chronic postoperative pulmonary insufficiency.


RESULTS
Thirteen sheep underwent baseline cardiac magnetic resonance imaging, surgical pulmonary valvectomy, and transannular patch repair. One month after transannular patch repair, the hTPV was implanted, followed by serial magnetic resonance imaging and computed tomography imaging at 1, 5, and 8 month(s). hTPV implantation was successful in 11 animals (85%). There were 2 procedural deaths related to ventricular fibrillation. Seven animals survived the entire follow-up protocol, 5 with functioning hTPV devices. Two animals had occlusion of hTPV with aneurysm of main pulmonary artery. A strong decline in pulmonary regurgitant fraction was observed after hTPV implantation (40.5% versus 8.3%; P=0.011). Right ventricular end diastolic volume increased by 49.4% after transannular patch repair (62.3-93.1 mL/m2; P=0.028) but was reversed to baseline values after hTPV implantation (to 65.1 mL/m2at 8 months, P=0.045). Both right ventricular ejection fraction and left ventricular ejection fraction were preserved after hTPV implantation.


CONCLUSIONS
hTPV implantation is feasible, significantly reduces pulmonary regurgitant fraction, facilitates right ventricular volume improvements, and preserves biventricular function in an ovine model of chronic pulmonary insufficiency. This percutaneous strategy could potentially offer an alternative for standard surgical pulmonary valve replacement in dilated right ventricular outflow tracts, permitting lower risk, nonsurgical pulmonary valve replacement in previously prohibitive anatomies.
From the Gorman Cardiovascular Research Group, Department of Surgery, The Children's Hospital of Philadelphia, PA (R.C.S., S.T., C.A., T.S., J.M., W.B., G.Z., R.C.G., J.H.G., M.J.G.); Department of Cardiology (M.A.H., G.L.F., T.S.K, Y.D., A.C.G, J.J.R., M.J.G.) and Department Radiology (H.L.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; and Department of Cardiothoracic Surgery, University Medical Center Groningen, University of Groningen, the Netherlands (R.C.S., W.B.).
Rosanne C
RC
Schoonbeek
From the Gorman Cardiovascular Research Group, Department of Surgery, The Children's Hospital of Philadelphia, PA (R.C.S., S.T., C.A., T.S., J.M., W.B., G.Z., R.C.G., J.H.G., M.J.G.); Department of Cardiology (M.A.H., G.L.F., T.S.K, Y.D., A.C.G, J.J.R., M.J.G.) and Department Radiology (H.L.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; and Department of Cardiothoracic Surgery, University Medical Center Groningen, University of Groningen, the Netherlands (R.C.S., W.B.).
Satoshi
S
Takebayashi
From the Gorman Cardiovascular Research Group, Department of Surgery, The Children's Hospital of Philadelphia, PA (R.C.S., S.T., C.A., T.S., J.M., W.B., G.Z., R.C.G., J.H.G., M.J.G.); Department of Cardiology (M.A.H., G.L.F., T.S.K, Y.D., A.C.G, J.J.R., M.J.G.) and Department Radiology (H.L.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; and Department of Cardiothoracic Surgery, University Medical Center Groningen, University of Groningen, the Netherlands (R.C.S., W.B.).
Chikashi
C
Aoki
From the Gorman Cardiovascular Research Group, Department of Surgery, The Children's Hospital of Philadelphia, PA (R.C.S., S.T., C.A., T.S., J.M., W.B., G.Z., R.C.G., J.H.G., M.J.G.); Department of Cardiology (M.A.H., G.L.F., T.S.K, Y.D., A.C.G, J.J.R., M.J.G.) and Department Radiology (H.L.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; and Department of Cardiothoracic Surgery, University Medical Center Groningen, University of Groningen, the Netherlands (R.C.S., W.B.).
Toru
T
Shimaoka
From the Gorman Cardiovascular Research Group, Department of Surgery, The Children's Hospital of Philadelphia, PA (R.C.S., S.T., C.A., T.S., J.M., W.B., G.Z., R.C.G., J.H.G., M.J.G.); Department of Cardiology (M.A.H., G.L.F., T.S.K, Y.D., A.C.G, J.J.R., M.J.G.) and Department Radiology (H.L.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; and Department of Cardiothoracic Surgery, University Medical Center Groningen, University of Groningen, the Netherlands (R.C.S., W.B.).
Matthew A
MA
Harris
From the Gorman Cardiovascular Research Group, Department of Surgery, The Children's Hospital of Philadelphia, PA (R.C.S., S.T., C.A., T.S., J.M., W.B., G.Z., R.C.G., J.H.G., M.J.G.); Department of Cardiology (M.A.H., G.L.F., T.S.K, Y.D., A.C.G, J.J.R., M.J.G.) and Department Radiology (H.L.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; and Department of Cardiothoracic Surgery, University Medical Center Groningen, University of Groningen, the Netherlands (R.C.S., W.B.).
Gregory L
GL
Fu
From the Gorman Cardiovascular Research Group, Department of Surgery, The Children's Hospital of Philadelphia, PA (R.C.S., S.T., C.A., T.S., J.M., W.B., G.Z., R.C.G., J.H.G., M.J.G.); Department of Cardiology (M.A.H., G.L.F., T.S.K, Y.D., A.C.G, J.J.R., M.J.G.) and Department Radiology (H.L.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; and Department of Cardiothoracic Surgery, University Medical Center Groningen, University of Groningen, the Netherlands (R.C.S., W.B.).
Timothy S
TS
Kim
From the Gorman Cardiovascular Research Group, Department of Surgery, The Children's Hospital of Philadelphia, PA (R.C.S., S.T., C.A., T.S., J.M., W.B., G.Z., R.C.G., J.H.G., M.J.G.); Department of Cardiology (M.A.H., G.L.F., T.S.K, Y.D., A.C.G, J.J.R., M.J.G.) and Department Radiology (H.L.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; and Department of Cardiothoracic Surgery, University Medical Center Groningen, University of Groningen, the Netherlands (R.C.S., W.B.).
Yoav
Y
Dori
From the Gorman Cardiovascular Research Group, Department of Surgery, The Children's Hospital of Philadelphia, PA (R.C.S., S.T., C.A., T.S., J.M., W.B., G.Z., R.C.G., J.H.G., M.J.G.); Department of Cardiology (M.A.H., G.L.F., T.S.K, Y.D., A.C.G, J.J.R., M.J.G.) and Department Radiology (H.L.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; and Department of Cardiothoracic Surgery, University Medical Center Groningen, University of Groningen, the Netherlands (R.C.S., W.B.).
Jeremy
J
McGarvey
From the Gorman Cardiovascular Research Group, Department of Surgery, The Children's Hospital of Philadelphia, PA (R.C.S., S.T., C.A., T.S., J.M., W.B., G.Z., R.C.G., J.H.G., M.J.G.); Department of Cardiology (M.A.H., G.L.F., T.S.K, Y.D., A.C.G, J.J.R., M.J.G.) and Department Radiology (H.L.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; and Department of Cardiothoracic Surgery, University Medical Center Groningen, University of Groningen, the Netherlands (R.C.S., W.B.).
Harold
H
Litt
From the Gorman Cardiovascular Research Group, Department of Surgery, The Children's Hospital of Philadelphia, PA (R.C.S., S.T., C.A., T.S., J.M., W.B., G.Z., R.C.G., J.H.G., M.J.G.); Department of Cardiology (M.A.H., G.L.F., T.S.K, Y.D., A.C.G, J.J.R., M.J.G.) and Department Radiology (H.L.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; and Department of Cardiothoracic Surgery, University Medical Center Groningen, University of Groningen, the Netherlands (R.C.S., W.B.).
Wobbe
W
Bouma
From the Gorman Cardiovascular Research Group, Department of Surgery, The Children's Hospital of Philadelphia, PA (R.C.S., S.T., C.A., T.S., J.M., W.B., G.Z., R.C.G., J.H.G., M.J.G.); Department of Cardiology (M.A.H., G.L.F., T.S.K, Y.D., A.C.G, J.J.R., M.J.G.) and Department Radiology (H.L.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; and Department of Cardiothoracic Surgery, University Medical Center Groningen, University of Groningen, the Netherlands (R.C.S., W.B.).
Gerald
G
Zsido
From the Gorman Cardiovascular Research Group, Department of Surgery, The Children's Hospital of Philadelphia, PA (R.C.S., S.T., C.A., T.S., J.M., W.B., G.Z., R.C.G., J.H.G., M.J.G.); Department of Cardiology (M.A.H., G.L.F., T.S.K, Y.D., A.C.G, J.J.R., M.J.G.) and Department Radiology (H.L.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; and Department of Cardiothoracic Surgery, University Medical Center Groningen, University of Groningen, the Netherlands (R.C.S., W.B.).
Andrew C
AC
Glatz
From the Gorman Cardiovascular Research Group, Department of Surgery, The Children's Hospital of Philadelphia, PA (R.C.S., S.T., C.A., T.S., J.M., W.B., G.Z., R.C.G., J.H.G., M.J.G.); Department of Cardiology (M.A.H., G.L.F., T.S.K, Y.D., A.C.G, J.J.R., M.J.G.) and Department Radiology (H.L.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; and Department of Cardiothoracic Surgery, University Medical Center Groningen, University of Groningen, the Netherlands (R.C.S., W.B.).
Jonathan J
JJ
Rome
From the Gorman Cardiovascular Research Group, Department of Surgery, The Children's Hospital of Philadelphia, PA (R.C.S., S.T., C.A., T.S., J.M., W.B., G.Z., R.C.G., J.H.G., M.J.G.); Department of Cardiology (M.A.H., G.L.F., T.S.K, Y.D., A.C.G, J.J.R., M.J.G.) and Department Radiology (H.L.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; and Department of Cardiothoracic Surgery, University Medical Center Groningen, University of Groningen, the Netherlands (R.C.S., W.B.).
Robert C
RC
Gorman
From the Gorman Cardiovascular Research Group, Department of Surgery, The Children's Hospital of Philadelphia, PA (R.C.S., S.T., C.A., T.S., J.M., W.B., G.Z., R.C.G., J.H.G., M.J.G.); Department of Cardiology (M.A.H., G.L.F., T.S.K, Y.D., A.C.G, J.J.R., M.J.G.) and Department Radiology (H.L.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; and Department of Cardiothoracic Surgery, University Medical Center Groningen, University of Groningen, the Netherlands (R.C.S., W.B.).
Joseph H
JH
Gorman
From the Gorman Cardiovascular Research Group, Department of Surgery, The Children's Hospital of Philadelphia, PA (R.C.S., S.T., C.A., T.S., J.M., W.B., G.Z., R.C.G., J.H.G., M.J.G.); Department of Cardiology (M.A.H., G.L.F., T.S.K, Y.D., A.C.G, J.J.R., M.J.G.) and Department Radiology (H.L.), Perelman School of Medicine, University of Pennsylvania, Philadelphia; and Department of Cardiothoracic Surgery, University Medical Center Groningen, University of Groningen, the Netherlands (R.C.S., W.B.). gillespie@email.chop.edu.
Matthew J
MJ
Gillespie
cardiac catheterization; computed tomography; heart valve prosthesis implantation; magnetic resonance imaging; pulmonary valve regurgitation; tetralogy of Fallot
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