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Transcatheter Pulmonary Valve Implantation Provides Effective Treatment
EDITORIAL
Heart, Lung and Circulation (2017) 26, 1004–1005 1443-9506/04/$36.00 http://dx.doi.org/10.1016/j.hlc.2017.08.002
Transcatheter Pulmonary Valve Implantation Provides Effective Treatment Andrew Cochrane, MBBS, FRACS a, Yves d’Udekem, MD, PhD b, Michael Cheung, MBBS, PhD c a
Dept of Cardiothoracic Surgery, Monash Medical Centre and Department of Surgery, Monash University, Melbourne, Vic, Australia Victorian Paediatric Cardiac Surgery Unit, Royal Children’s Hospital and Department of Paediatrics, University of Melbourne, Melbourne, Vic, Australia Department of Cardiology, Royal Children’s Hospital and Department of Paediatrics, University of Melbourne, Melbourne, Vic, Australia
b c
Keywords
Pulmonary valve replacement Pulmonary regurgitation Melody valve
In this issue of the Journal, Markham et al. from the Prince Charles Hospital in Brisbane [1] present the first published experience in Australia of transcatheter pulmonary valve implantation (TPVI), in this case with the Melody valve (Medtronic Inc, Minneapolis, USA). They have documented a mean follow-up of almost three years, with the longest experience with the valve out to six years. Surgical interventions on the pulmonary valve and right ventricular outflow tract (RVOT) are an important component of cardiac surgery for many congenital heart defects, such as Fallot’s tetralogy, pulmonary atresia and truncus arteriosus. Late sequelae of these surgical interventions are common, with varying mixtures of pulmonary valve stenosis, RVOT stenosis, and valvular regurgitation. Historically, further surgical intervention has been the only effective therapy. However, the use of TPVI, first reported in 2000 by Bonhoeffer [2], has opened up another option for many patients, particularly in adolescence and adult life when a full-size bioprosthesis can be implanted. The report from Prince Charles Hospital of 17 patients, from 15 to 60 years of age, demonstrates excellent results in a selected group of patients, with no deaths, no major implantation complications, good reduction of the RVOT gradient and excellent relief of regurgitation, with no pulmonary regurgitation being present in 15 of the 17 patients at the latest follow-up. These results compare very favourably with other experience around the world. The largest published experience, from the UK and France, reported 155 patients with a fairly short median follow-up of 28 months [3]. Survival was good,
but there was disappointing freedom from reintervention of 73% at four years post-implantation, usually managed with further catheter intervention. The US Melody valve Investigational Device Exemption trial reported 150 valve implants, with all patients at least four years from implant, and longest follow-up to seven years [4]. The freedom from reintervention in that study was 76% at five years, with a similar moderately high rate of reintervention/redilation for persisting stenosis, and a valve stent fracture documented in 50 patients. Indeed, the main cause of valve dysfunction appeared to be related to stent fracture, a problem which seems to be occurring less commonly now with pre-stenting of the outflow tract prior to TPVI. This Australian report, having learnt from the overseas experience, emphasises the importance of pre-stenting of the RVOT and annulus, before placement of the Melody valve, which provides a defined conduit for delivery of the Melody valve. This step before valve implantation reduces the radial load on the bioprosthesis and the incidence of strut fracture. The authors also demonstrate cost equivalence with open surgery, while avoiding the discomfort and prolonged recovery involved with open cardiac surgery. More recent studies have demonstrated the possibility of implanting the Melody valve within existing Contegra conduits with good haemodynamic results. The recent multicentre report employing this strategy [5] showed that it was possible to implant valves within Contegra valve conduits as small as 12 mm. This opens up the potential application of TPVI to a younger population of patients.
DOI of original article: http://dx.doi.org/10.1016/j.hlc.2016.12.004 © 2017 Published by Elsevier B.V. on behalf of Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ).
1005
The use of TPVI is still currently limited in the presence of a large RVOT or pulmonary annulus diameter, over 22 mm at present, although technologic improvements of this device and the use of other devices will continue to reduce this limitation. Lastly, the late occurrence of infective endocarditis remains an important issue. This series reports one patient who went on after an episode of endocarditis to develop stenosis of the Melody valve, and other national registries report similar events. The US Melody study [4] reported subsequent endocarditis in 14 of 150 patients, although the majority settled with antibiotic therapy alone. However, there remains an important intermediate and long-term risk of infective endocarditis, as for any prosthetic valve, and unprotected invasive events should be avoided. It seems as though endocarditis may be a problem with the use of the bovine jugular vein valved conduit rather than the implantation technique itself, however. Surgically implanted Contegra valve conduits, which are a bovine jugular vein conduit, had a 9.4% infection rate compared to a 0.7% rate for pulmonary homografts in the series from Edmonton [6]. A study from Europe comparing surgically implanted Contegra conduits, Melody valves and surgically implanted pulmonary homografts showed infection rates of 20%, 7.5% and 2.4% respectively [7]. A recent systematic review of 7063 patients with pulmonary valve replacements reported 181 cases of endocarditis, and found that the risk of infection was higher with the bovine jugular vein valve (5.4%) compared to all others (1.2%) [8]. These authors also showed that there was no difference between surgically placed valves and transcatheter implanted bovine jugular vein valves. It is clear that transcatheter techniques to manage valve disease are maturing and the problem of stent fracture and
residual stenosis in the early experience of TPVI has resulted in improved insertion techniques. The problem of infective endocarditis is of concern for the outcome of pulmonary valve replacement, whatever the method of implantation.
References [1] Markham R, Challa A, Kyranis S, Nicolae M, Murdoch D, Savage M, Malpas T, et al. Outcomes Following Melody Transcatheter Pulmonary Valve Implantation for Right Ventricular Outflow Tract Dysfunction in Repaired Congenital Heart Disease: First Reported Australian Single Centre Experience. Heart Lung & Circulation 2017;26:1085–93. [2] Bonhoeffer P, Boudjemline Y, Saliba Z, Merck XJ, Aggoun Y, Bonnet D, et al. Percutaneous replacement of pulmonary valve in a right-ventricle to pulmonary-artery prosthetic conduit with valve dysfunction. Lancet 2000;356(9239):1403–5. [3] Lurz P, Coats L, Khambadkone S, Nordmeyer J, Boudjemline Y, Schievano S, et al. Percutaneous Pulmonary Valve Implantation: Impact of Evolving Technology and Learning Curve on Clinical Outcome. Circulation 2008;117:1964–72. [4] Cheatham JP, Hellenbrand WE, Zahn EM, Jones TK, Berman DP, Vincent JA, et al. Clinical and Hemodynamic Outcomes Up to 7 Years After Transcatheter Pulmonary Vlave replacement in the US Melody Valve Investigational Device Exemption Trial. Circulation 2015;131:1960–70. [5] Morray BH, McElhinney DB, Boudjemline Y, Gewillig M, Kim DW, et al. Multicentre Experience Evaluating Transcatheter Pulmonary Valve Replacement in Bovine Jugular Vein (Contegra) Right Ventricle to Pulmonary Artery Conduits. Circ Cardiovasc Interv 2017;10:e004914. http:// dx.doi.org/10.1161/CIRCINTERVENTIONS.116.004914. [6] Ugaki S, Rutledge J, Al Aklabi M, Ross DB, Adatia I, Rebeyka IM. An Increased Incidence of Conduit Endocarditis in Patients Receiving Bovine Jugular Vein Grafts Compared to Cryopreserved Homograft for Right Ventricular Outflow Reconstruction. Ann Thoracic Surg 2015;99:140–7. [7] Van Dijck I, Budts W, Cools B, Eyskens B, Boshoff DE, et al. Infective endocarditis of a transcatheter pulmonary valve in comparison with surgical implants. Heart 2015;(101):788. [8] Sharma A, Cote AT, Hosking MCK, Harris KC. A Systematic Review of Infective Endocarditis in Patients with Bovine Jugular Vein Valves Compared with Other Valves. JACC Cardiovasc Interv 2017 Jul 24;10(14):1449– 58.
Heart, Lung and Circulation (2017) 26, 1004–1005 1443-9506/04/$36.00 http://dx.doi.org/10.1016/j.hlc.2017.08.002
Transcatheter Pulmonary Valve Implantation Provides Effective Treatment Andrew Cochrane, MBBS, FRACS a, Yves d’Udekem, MD, PhD b, Michael Cheung, MBBS, PhD c a
Dept of Cardiothoracic Surgery, Monash Medical Centre and Department of Surgery, Monash University, Melbourne, Vic, Australia Victorian Paediatric Cardiac Surgery Unit, Royal Children’s Hospital and Department of Paediatrics, University of Melbourne, Melbourne, Vic, Australia Department of Cardiology, Royal Children’s Hospital and Department of Paediatrics, University of Melbourne, Melbourne, Vic, Australia
b c
Keywords
Pulmonary valve replacement Pulmonary regurgitation Melody valve
In this issue of the Journal, Markham et al. from the Prince Charles Hospital in Brisbane [1] present the first published experience in Australia of transcatheter pulmonary valve implantation (TPVI), in this case with the Melody valve (Medtronic Inc, Minneapolis, USA). They have documented a mean follow-up of almost three years, with the longest experience with the valve out to six years. Surgical interventions on the pulmonary valve and right ventricular outflow tract (RVOT) are an important component of cardiac surgery for many congenital heart defects, such as Fallot’s tetralogy, pulmonary atresia and truncus arteriosus. Late sequelae of these surgical interventions are common, with varying mixtures of pulmonary valve stenosis, RVOT stenosis, and valvular regurgitation. Historically, further surgical intervention has been the only effective therapy. However, the use of TPVI, first reported in 2000 by Bonhoeffer [2], has opened up another option for many patients, particularly in adolescence and adult life when a full-size bioprosthesis can be implanted. The report from Prince Charles Hospital of 17 patients, from 15 to 60 years of age, demonstrates excellent results in a selected group of patients, with no deaths, no major implantation complications, good reduction of the RVOT gradient and excellent relief of regurgitation, with no pulmonary regurgitation being present in 15 of the 17 patients at the latest follow-up. These results compare very favourably with other experience around the world. The largest published experience, from the UK and France, reported 155 patients with a fairly short median follow-up of 28 months [3]. Survival was good,
but there was disappointing freedom from reintervention of 73% at four years post-implantation, usually managed with further catheter intervention. The US Melody valve Investigational Device Exemption trial reported 150 valve implants, with all patients at least four years from implant, and longest follow-up to seven years [4]. The freedom from reintervention in that study was 76% at five years, with a similar moderately high rate of reintervention/redilation for persisting stenosis, and a valve stent fracture documented in 50 patients. Indeed, the main cause of valve dysfunction appeared to be related to stent fracture, a problem which seems to be occurring less commonly now with pre-stenting of the outflow tract prior to TPVI. This Australian report, having learnt from the overseas experience, emphasises the importance of pre-stenting of the RVOT and annulus, before placement of the Melody valve, which provides a defined conduit for delivery of the Melody valve. This step before valve implantation reduces the radial load on the bioprosthesis and the incidence of strut fracture. The authors also demonstrate cost equivalence with open surgery, while avoiding the discomfort and prolonged recovery involved with open cardiac surgery. More recent studies have demonstrated the possibility of implanting the Melody valve within existing Contegra conduits with good haemodynamic results. The recent multicentre report employing this strategy [5] showed that it was possible to implant valves within Contegra valve conduits as small as 12 mm. This opens up the potential application of TPVI to a younger population of patients.
DOI of original article: http://dx.doi.org/10.1016/j.hlc.2016.12.004 © 2017 Published by Elsevier B.V. on behalf of Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ).
1005
The use of TPVI is still currently limited in the presence of a large RVOT or pulmonary annulus diameter, over 22 mm at present, although technologic improvements of this device and the use of other devices will continue to reduce this limitation. Lastly, the late occurrence of infective endocarditis remains an important issue. This series reports one patient who went on after an episode of endocarditis to develop stenosis of the Melody valve, and other national registries report similar events. The US Melody study [4] reported subsequent endocarditis in 14 of 150 patients, although the majority settled with antibiotic therapy alone. However, there remains an important intermediate and long-term risk of infective endocarditis, as for any prosthetic valve, and unprotected invasive events should be avoided. It seems as though endocarditis may be a problem with the use of the bovine jugular vein valved conduit rather than the implantation technique itself, however. Surgically implanted Contegra valve conduits, which are a bovine jugular vein conduit, had a 9.4% infection rate compared to a 0.7% rate for pulmonary homografts in the series from Edmonton [6]. A study from Europe comparing surgically implanted Contegra conduits, Melody valves and surgically implanted pulmonary homografts showed infection rates of 20%, 7.5% and 2.4% respectively [7]. A recent systematic review of 7063 patients with pulmonary valve replacements reported 181 cases of endocarditis, and found that the risk of infection was higher with the bovine jugular vein valve (5.4%) compared to all others (1.2%) [8]. These authors also showed that there was no difference between surgically placed valves and transcatheter implanted bovine jugular vein valves. It is clear that transcatheter techniques to manage valve disease are maturing and the problem of stent fracture and
residual stenosis in the early experience of TPVI has resulted in improved insertion techniques. The problem of infective endocarditis is of concern for the outcome of pulmonary valve replacement, whatever the method of implantation.
References [1] Markham R, Challa A, Kyranis S, Nicolae M, Murdoch D, Savage M, Malpas T, et al. Outcomes Following Melody Transcatheter Pulmonary Valve Implantation for Right Ventricular Outflow Tract Dysfunction in Repaired Congenital Heart Disease: First Reported Australian Single Centre Experience. Heart Lung & Circulation 2017;26:1085–93. [2] Bonhoeffer P, Boudjemline Y, Saliba Z, Merck XJ, Aggoun Y, Bonnet D, et al. Percutaneous replacement of pulmonary valve in a right-ventricle to pulmonary-artery prosthetic conduit with valve dysfunction. Lancet 2000;356(9239):1403–5. [3] Lurz P, Coats L, Khambadkone S, Nordmeyer J, Boudjemline Y, Schievano S, et al. Percutaneous Pulmonary Valve Implantation: Impact of Evolving Technology and Learning Curve on Clinical Outcome. Circulation 2008;117:1964–72. [4] Cheatham JP, Hellenbrand WE, Zahn EM, Jones TK, Berman DP, Vincent JA, et al. Clinical and Hemodynamic Outcomes Up to 7 Years After Transcatheter Pulmonary Vlave replacement in the US Melody Valve Investigational Device Exemption Trial. Circulation 2015;131:1960–70. [5] Morray BH, McElhinney DB, Boudjemline Y, Gewillig M, Kim DW, et al. Multicentre Experience Evaluating Transcatheter Pulmonary Valve Replacement in Bovine Jugular Vein (Contegra) Right Ventricle to Pulmonary Artery Conduits. Circ Cardiovasc Interv 2017;10:e004914. http:// dx.doi.org/10.1161/CIRCINTERVENTIONS.116.004914. [6] Ugaki S, Rutledge J, Al Aklabi M, Ross DB, Adatia I, Rebeyka IM. An Increased Incidence of Conduit Endocarditis in Patients Receiving Bovine Jugular Vein Grafts Compared to Cryopreserved Homograft for Right Ventricular Outflow Reconstruction. Ann Thoracic Surg 2015;99:140–7. [7] Van Dijck I, Budts W, Cools B, Eyskens B, Boshoff DE, et al. Infective endocarditis of a transcatheter pulmonary valve in comparison with surgical implants. Heart 2015;(101):788. [8] Sharma A, Cote AT, Hosking MCK, Harris KC. A Systematic Review of Infective Endocarditis in Patients with Bovine Jugular Vein Valves Compared with Other Valves. JACC Cardiovasc Interv 2017 Jul 24;10(14):1449– 58.