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This Thesis Has Been Submitted in Fulfilment of the Requirements for a Postgraduate Degree (E.G This thesis has been submitted in fulfilment of the requirements for a postgraduate degree (e.g. PhD, MPhil, DClinPsychol) at the University of Edinburgh. Please note the following terms and conditions of use: This work is protected by copyright and other intellectual property rights, which are retained by the thesis author, unless otherwise stated. A copy can be downloaded for personal non-commercial research or study, without prior permission or charge. This thesis cannot be reproduced or quoted extensively from without first obtaining permission in writing from the author. The content must not be changed in any way or sold commercially in any format or medium without the formal permission of the author. When referring to this work, full bibliographic details including the author, title, awarding institution and date of the thesis must be given. The development of catheter techniques to treat native and acquired stenoses in congenital heart disease. Alan Gordon Magee Doctor of Medicine University of Edinburgh 2015 Declaration (a) this thesis has been composed by myself, (b) either the work is my own or if I have been a member of a research group I have made a substantial contribution to the work and my contribution is clearly indicated, (c) that the work has not been submitted for any other degree or professional qualification except as specified, and (d) that any included publications are my own work. Signed Date 1/12/15 I Abstract Aim: To describe innovative uses of catheter based treatment in a variety of native and post surgical stenoses in children and young adults with congenital heart disease. Background: Cardiac catheterization in man was first described 1929 and since then there has been a drive to develop endovascular techniques to investigate and treat both congenital and acquired heart disease. Many of the advances are being made in congenital heart disease. Methods: A number of congenital cardiac stenotic lesions were studied including baffle obstruction after atrial switch for transposition of the great arteries, aortic stenosis in infants, coarctation of the aorta, peripheral pulmonary artery stenosis and superior vena caval obstruction. The use of angioplasty balloons, cutting balloons, stents and alternative catheter approaches were investigated for these lesions. Results: Following atrial redirection surgery for transposition of the great arteries balloon angioplasty improved baffle haemodynamics. The technique of anterograde balloon dilation of the aortic valve was developed and had superior outcomes in terms of aortic insufficiency compared to a retrograde approach in neonates with severe aortic valve stenosis. In an animal model of peripheral pulmonary arterial stenosis, the application of cutting balloon angioplasty produced effective relief in a controlled II fashion. Balloon mounted stents were used in patients with native and post surgical coarctation of the aorta with significant relief of stenosis and relief of hypertension. Finally, a group of patients with superior vena obstruction syndrome after surgical repair of partial anomalous pulmonary venous drainage had successful treatment using balloon mounted stents. Conclusions: Catheter based treatment of congenital and post surgical vascular stenoses of the heart and great arteries using angioplasty balloons, cutting balloons and balloon mounted stents is safe and appears to be effective in the short and medium term. It may represent a useful alternative to surgery and will reduce the number of surgical procedures required over a lifetime. Future directions will include bio-absorbable stents and hybrid techniques involving surgery. III Lay summary Congenital heart disease is the commonest birth abnormality with an incidence of 8 per 1000 live births. There is a wide spectrum of disease and in the majority of children the heart is the only organ affected. About half of these children will need treatment to correct or at least lessen the physical impact of their condition. In most cases, it is the structure of the heart which is affected and therefore treatment has to be in the form of an operation or in some children a series of operations which may extend over the individuals lifetime. In order to reduce the impact of surgery, which can be particularly significant in young babies, non surgical alternative treatments using cardiac catheter techniques are being developed. These techniques involve entry into the circulation usually via the artery and vein at the top of the leg followed by treating the defect in the heart or the great vessels close to the heart from the inside as opposed to treating from the outside which is what happens during surgery. The heart is reached by long fine plastic tubes called catheters supported by fine guide wires and the abnormality is addressed using different types of inflatable balloons and devices which are mounted at the ends of catheters or guide wires. This thesis describes innovations in the use of catheter mounted balloons and particular devices called stents, which support vessel walls, to treat of a number of either native or post surgical obstructions within the heart or great vessels in children and adults affected by congenital heart disease. It also addresses how the application of this IV technology can complement heart surgery, reduce the number of operations required over a lifetime and how it might develop in the future. V Table of contents Declaration!! ! ! ! ! ! ! Ⅰ Abstract Ⅱ Lay summary Ⅳ Table of contents Ⅵ List of figures Ⅷ List of tables Ⅻ List of publications XIII Acknowledgements XV Dedication XVI CHAPTER 1: Introduction and rationale. 1 CHAPTER 2: The management of systemic venous pathway obstruction after the Mustard Procedure. 28 CHAPTER 3: Experimental branch pulmonary artery stenosis angioplasty using a novel cutting balloon. 40 CHAPTER 4: Balloon dilation of severe aortic stenosis in the neonate: comparison of anterograde and retrograde catheter approaches. 54 VI CHAPTER 5: Aortopathy Part 1: Stent implantation for aortic coarctation and recoarctation 74 Part 2: Combined interventional and surgical management of aortic stenosis and coarctation 95 CHAPTER 6: Balloon expandable stent implantation in the treatment of superior vena caval obstruction. 102 CHAPTER 7: Discussion and future direction. 114 BIBLIOGRAPHY 127 APPENDIX: Published papers 165 VII List of figures Figure 1, page 4. The classical Blalock-Taussig Shunt. Figure 2, page 5. Resection and end to end anastomosis of coarctation of the aorta, as described by Crafoord and Nyhlin. Figure 3, page 7. Schematic illustration of the first case of controlled cross circulation. Figure 4, page 8. The Chest X-Ray of Dr Werner Forssman showing the catheter advanced from the left ante-cubital vein and lying with the tip within the right atrium. Figure 5, page 10. Diagram of transventricular pulmonary valvotomy developed by Sellors and Brock. Figure 6, page 11. Illustration of the first successful transcatheter valvotomy by Rubio- Alvarez. Figure 7, 12. page. Reproduction of the original illustration from Seldinger. Figure 8, page 13. Diagram of the normal heart and a heart with transposition of the great arteries. VIII Figure 9, page 14. Illustration of Blalock-Hanlon sepectomy. Figure 10, page 15. Still image of balloon atrial septostomy under fluoroscopic control in a neonate with transposition of the great arteries. Figure 11, page 17. Angioplasty of the popliteal artery by Charles Dotter. Figure 12, page 19. Lateral angiogram of balloon dilation of the pulmonary valve. Figure 13, page 21. Spiral spring stents, single and double helex developed by Maass for endovascular implantation. Figure 14, page 29. Diagram of the Mustard procedure for transposition of the great arteries. Figure 15, page 32. Angiogram of narrow superior systemic venous pathway following the Mustard procedure. Figure 16, page 36. Pullback pressure gradients and minimum pathway diameters before and after angioplasty procedures. Figure 17, page 45. Diagram of Interventional Technologies cutting balloon. IX Figure 18, page 46. Pullback pressure tracing across left pulmonary artery in animal 1 before and after cutting balloon angioplasty. Figure 19, page 51. Scanning electron micrograph with 1 mm distance marker showing luminal surface of pulmonary artery. Figure 20, page 61. Balloon dilation of the aortic valve using an antegrade approach in a 3.8-kg neonate. Figure 21, page 82. Long axis aortogram using a ‘marker’ pigtail catheter showing discrete native coarctation in a patient before (A) and after (B) stent implantation. Figure 22, page 83. Follow up spiral computed tomography (CT) with contrast showing stented aorta in cross section (A) and axial three dimensional reconstruction (B). Figure 23, page 88. Three dimensional reconstruction of spiral computed tomography images with contrast taken nine months after stent implantation. Figure 24, page 99. Aortogram in a right anterior oblique projection showing a discrete coarctation of the aorta just distal to the left subclavian artery in a patient who required surgery for severe calcific aortic stenosis, before (A) and after (B) stent implantation. X Figure 25, page 104. Diagram of Warden procedure for repair of partial anomalous pulmonary venous return. Figure 26, page 107. Lateral SVC angiogram before (A) and after (B) stent implantation in patient 2. Figure 27, page 110. Lateral angiograms in the third patient 6.5 years after initial stent implantation showing 2 stent fractures before and after further stent
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