Overview
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Appendix
The following table outlines the studies that are considered potentially relevant to the IP overview but were not included in the summary of the key evidence. It is by no means an exhaustive list of potentially relevant studies.
Article | Number of patients/ follow-up | Direction of conclusions | Reasons for non-inclusion in summary of key evidence section |
|---|---|---|---|
Austin C, Fittipaldi M, Thompson P et al. (2021) The consequences of incomplete covering of the critical part of the aortic root in Personalized External Aortic Root Support. European Journal of Cardio-thoracic Surgery 59: 1095 | Case report n=1 | In 2015, a patient had surgery in which the external aortic root support was incorrectly fitted. The surgeon cut-off and discarded the portion of the mesh, custom manufactured to fit the aortic sinuses and tethered the cut end of the remaining implant to the adventitia above the coronary arteries. The aortic diameter at the level of leaflet closure increased from 49 to 62 mm over 18 months with worsening aortic regurgitation. At reoperation, a further personalised mesh was fitted. Size reduction was achieved down to 46 mm on the postoperative measurement. The patient made a good recovery and remains well but with mild residual aortic valve regurgitation. | Case report in which the protocol for inserting the support was not followed, and the aortic root continued to expand. |
Benedetto U, Jin XY, Hill E et al. (2016) An option for concomitant management of moderate Marfan root aneurysm at the time of mitral valve repair: a role for personalized external aortic root support. The Annals of Thoracic Surgery 102: e499–501 | Case report n=2 | Two patients had mitral valve repair for severe regurgitation in the presence of a Marfan aortic root aneurysm. Concomitant PEARS was used at the same operation to halt aneurysm progression and to correct mild aortic regurgitation. | Case report of concomitant external aortic root support and mitral valve repair. |
DiMario C, Pepper J, Golesworthy T et al. (2012) External aortic root support for the Marfan aorta: anatomically normal coronary orifices imaged seven years after surgery. Interactive Cardiovascular and Thoracic Surgery 15: 528–30 | Case report n=1 FU=7 years | The patient presented with angina 7 years after having the procedure. The cause of angina was an atherosclerotic left anterior descending coronary artery stenosis, which was successfully stented. Aortography and coronary angiography showed widely patent coronary orifices with no sign of impingement of the external support on the smooth lumen of his coronary arteries. | Case report – already described within a larger study. |
Izgi C, Nyktari E, Alpendurada F et al. (2015) Effect of personalized external aortic root support on aortic root motion and distension in Marfan syndrome patients. International Journal of Cardiology 197: 154–60 | Case series n=24 FU=median 50.5 months | The procedure decreases systolic downward aortic root motion which is an important determinant of longitudinal aortic wall stress. Aortic wall distension and Windkessel function are not significantly impaired in the follow-up after implantation of the mesh which is also supported by the lack of deterioration of left ventricle volumes or mass. | A more recent study from the same author is included. |
Pepper J, Chan KMJ, Gavino J et al. (2010) External aortic root support for Marfan syndrome: early clinical results in the first 20 recipients with a bespoke implant. Journal of the Royal Society of Medicine 103: 370–5 | Case series n=20 FU=median 20 months | Median change in aortic root diameter during follow-up (assessed by MRI scans) (n=16) = −1 mm (range −6 to +3). One patient had a post-operative cardiac arrest with ventricular fibrillation. The circulation was restored after removing the anterior closing suture on the aortic root support. Another patient had anatomical anomalies in the coronary arteries, so further imaging was needed before the procedure could be completed a week later. | Larger and more recent studies are included, with the same patients. |
Pepper J, Golesworthy T, Utley M et al. (2010) Manufacturing and placing a bespoke support for the Marfan aortic root: description of the method and technical results and status at one year for the first ten patients. Interactive Cardiovascular and Thoracic Surgery 10: 360–5 | Case series n=10 FU=at least 12 months | For 8 of the 10 patients, the largest observed difference between the diameter of the aortic root before and at least 1 year after surgery was a marked reduction in diameter. There were no deaths, late events or detected changes in aortic valve function. Arrhythmia (transient atrial fibrillation)=20% (2/10) | Larger and more recent studies are included, with the same patients. |
Singh SD, Xu XY, Wood NB et al. (2016) Aortic flow patterns before and after personalised external aortic root support implantation in Marfan patients. Journal of Biomechanics 49: 100–11 | Case series n=3 | The qualitative patterns of the haemodynamics were similar before and after the procedure. The post-procedure aortas had slightly less disturbed flow at the sinuses, because of reduced diameters in the aortic roots. All values of helicity flow index were within the range reported for normal aortas. | Small study focusing on haemodynamics. |
Treasure T, King A, Hidalgo Lemp L et al. (2018) Developing a shared decision support framework for aortic root surgery in Marfan syndrome. Heart (British Cardiac Society) 104: 480–6 | Survey n=142 | 46% of respondents had previous aortic root surgery. Overall, active lifestyle was more important to males (p=0.03). Patients placed more importance than doctors on not deferring surgery (p=0.04) and on avoidance of anticoagulation in the interests of childbearing (p=0.009). Qualitative analysis showed differing but cogently reasoned values that were sometimes polarised, and mainly driven by the wish to maintain a good quality of life and active lifestyle. | Study focusing on development of a decision support framework for aortic surgery in Marfan syndrome. |
Treasure T, Petrou M, Rosendahl U et al. (2016) Personalized external aortic root support: a review of the current status. European Journal of Cardio-thoracic Surgery 50: 400–4 | Review | More than 60 patients have had this surgery in a 12-year period. Operations have been done in 6 centres and follow up is more than 260 patient-years. It is possible that the procedure may prove to be a definitive means to hold the sinuses at a size and shape that allow the aortic valve to remain competent. In the 2 cases where the aorta has been examined years after the mesh has become incorporated, the macroscopic and histological appearances make acute aortic dissection originating in the root seem much less likely than it would otherwise have been. | Review |
Treasure T, Takkenberg JJM, Pepper J (2016) Surgical management of aortic root disease in Marfan syndrome and other congenital disorders associated with aortic root aneurysms. Postgraduate Medical Journal 92: 112–7 | Review | Three forms of surgery are now available: total root replacement with a valved conduit, valve sparing root replacement and PEARS with a macroporous mesh sleeve. In evaluation of these 3 forms of surgery, the number needed to treat to prevent dissection and the balance of net benefit and harm in future patients must be considered. | Review |
Treasure T, Takkenberg JJM, Pepper J (2014) Surgical management of aortic root disease in Marfan syndrome and other congenital disorders associated with aortic root aneurysms. Heart (British Cardiac Society) 100: 1571–6 | Review | The recommended size criteria for intervention on the aortic root to avert dissection are based on the risk of further waiting balanced against the procedural risk of the surgery. Better data are needed to know the number needed to treat and to have comparative effectiveness and cost effectiveness data for the 3 surgical approaches. | Review |
Treasure T, Golesworthy T, Pepper J et al. (2011) Prophylactic surgery of the aortic root in Marfan Syndrome: Reconsideration of the decision making process in the era of customised external aortic root support. Italian Journal of Vascular and Endovascular Surgery 18: 215–23 | Review | At the time of the review, 25 patients had been treated. All were alive and well at median follow up of 44 months. In making the decision about the choice of surgery there is a complex trade off of the ongoing risk of dissection if surgery is deferred versus the risk of the operation itself and of the ensuing lifetime consequences. | Studies with more detailed outcomes from the same patients are included. |
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