Papers by Tal Golesworthy
Journal of Thoracic Disease, Sep 1, 2017
Translational medicine communications, Oct 22, 2019
Background: This article presents examples of how to utilize the research output, to initiate aca... more Background: This article presents examples of how to utilize the research output, to initiate academia-industry interaction, with the ultimate task of launching a new product: a smart heart valve prosthesis for pediatric patients. The article summarizes our efforts in a way that may also be informative to researchers working in fields other than medical devices development. Our task is not to provide a step-by-step guide, but rather to create inspiration, also by describing differences in expectations of business and academic entities. Methods: We analyzed market reports, surveyed the scientific literature and conducted interviews with the key players in the field of medical devices. We also obtained a feedback from clinicians, academia and industry-related researchers, technology transfer centres, representatives of public organization and the creators of legislation. Results: We have obtained and reported the definitive answers that together constitute a critical review of strategies that should be used by researchers who seek to commercialize the outputs of their research. Conclusion: As a result of our investigation, we discovered that the commercialization of research is a complex process, which in some critical aspects does not depend solely on the researcher himself. The most promising ideas, supported by strong experimental evidence, can simply be overlooked by industry representatives, without the proper support of institutions such as a technology transfer centre. Besides, the involvement of scientists in a business project takes them, at least temporarily, outside the regular academic environment, which may cause discomfort and pose a risk to the career path. The limitation to be addressed is the reluctance to report the unsuccessful attempts, which should be considered a legitimate educational experience that ultimately leads to improvement.
Operative Techniques in Thoracic and Cardiovascular Surgery, 2021
Abstract The PEARS procedure offers a novel alternative to traditional surgical options for aorti... more Abstract The PEARS procedure offers a novel alternative to traditional surgical options for aortic root aneurysms in patients with connective tissue disorders and neo-aortic root dilatation following the arterial switch or Ross procedures. It has a lower biological insult than conventional surgical management with shorter operating times and avoidance of CPB and cardioplegic arrest in most cases. The patient's own valve, root architecture and blood to vessel wall interface is maintained. Avoidance of mechanical valve replacement negates the requirement for anticoagulation which is especially beneficial in young patients. This article aims to describe the key principles and operative steps for implanting the PEARS device. We describe the technical steps applicable to all PEARS implants and have included our tips and tricks at each stage. We consider PEARS to be a valid alternative therapeutic option for surgical teams managing patients with aortopathies. (140 words)
Circulation, Nov 14, 2017
We have designed and applied a Personalised External Aortic Root Support (PEARS) in more than 100... more We have designed and applied a Personalised External Aortic Root Support (PEARS) in more than 100 patients. This mesh sleeve support is constructed by 3D printing from the patient’s digital imaging...
The Lancet, Feb 1, 2005
The paper focused on the fact that there was a relationship between the tobacco industry and Jame... more The paper focused on the fact that there was a relationship between the tobacco industry and James Parry, one of the editors of Mutagenesis, which is published by OUP on behalf of the UK Environmental Mutagen Society (UKEMS). We were first made aware of this relationship in April, 2001, and took immediate action. We strongly reject any implication that our response was not swift enough and that our requirements should have been stricter. As soon as OUP received evidence of this relationship, we contacted both Parry and UKEMS, which is responsible for the appointment of editors and members of the editorial board (a fact that was omitted from the article). A conflict of interest policy was introduced from April, 2001, and Parry, who did not sign up to the arrangement, left his role as Executive Editor at the end of 2001 and transferred to a non-executive role on the editorial board. We are satisfied that, because decisions on manuscripts are made by the editors, not by members of the editorial board, our policy for declaration of conflict of interest in the publication of Mutagenesis has been effective since the end of 2001. Parry is no longer a member of the editorial board of Mutagenesis.
Heart, Jul 29, 2021
Background and objectives In Personalised External Aortic Root Support (PEARS) a custom-made, mac... more Background and objectives In Personalised External Aortic Root Support (PEARS) a custom-made, macroporous mesh is used to stabilise a dilated aortic root and prevent dissection, primarily in patients with genetically driven aortopathies. Data are needed on the safety and postoperative incidence of aortic events. Methods We present a multicentre cohort study evaluating the first 200 consecutive patients (median age 33y) undergoing surgery with an intention to perform PEARS for aortic root dilatation in 23 centres between 2004-2019. Perioperative outcomes were collected prospectively while clinical follow-up was retrieved retrospectively. Median follow-up was 21.2 months. Results The main indication was Marfan syndrome (73.5%) and the most frequent concomitant procedure was mitral valve repair (10%). An intervention for myocardial ischemia or coronary injury was needed in 11 patients, 1 case resulting in perioperative death. No ascending aortic dissections were observed in 596 documented postoperative patient years. Late reoperation was performed in 3 patients for operator failure to achieve complete mesh coverage. Among patients with at least mild AR preoperatively, 68% had no or trivial AR at follow-up. Conclusions This study represents the clinical history of the first 200 patients to undergo PEARS. To date, aortic dissection has not been seen in the restrained part of the aorta, yet long-term follow-up is needed to confirm the potential of PEARS to prevent dissection. While operative mortality is low, the observed coronary complications reflect the learning curve of aortic root surgery in patients with connective tissue disease. PEARS may stabilise or reduce aortic regurgitation.
Personalized External Aortic Root Support (PEARS) surgery was started in 2004 at the Royal Brompt... more Personalized External Aortic Root Support (PEARS) surgery was started in 2004 at the Royal Brompton Hospital, London, and has now been used to treat over 100 patients with asymptomatic aortic dilation related to Marfan Syndrome, Loeys-Dietz Syndrome, Bicuspid Aortic Valve disease, Turner's Syndrome, and various other congenital conditions involving asymptomatic aortic dilation. It retains all of the native structures, but reinforces the aortic root to halt dilation. In this video, PEARS inventor and first patient, Tal Golesworthy, interviews the 100th PEARS patient.Disclosure: Tal Golesworthy is the inventor of PEARS and was the first recipient of a PEARS implant with respect to his own Marfanoid aorta. Mr Golesworthy is a director and shareholder of Exstent, Ltd, which makes the ExoVasc® Personalized External Aortic Root Support.<br>
The Annals of Thoracic Surgery, Oct 1, 2015
the best treatment leading to satisfactory long-term oncologic results has not been found yet. Th... more the best treatment leading to satisfactory long-term oncologic results has not been found yet. The most important thing we learned about treatment of malignant pleural mesothelioma is that surgery plays an important role in cytoreduction, but it cannot be considered alone even in early stage diseases and it must always be associated with other therapies both in a neoadjuvant and adjuvant set [2]. In addition to this, a wide range of therapies may be added during surgery to increase the local control of the disease (intraoperative adjuvant chemotherapy, intrapleural iodine povidone solution, or photodynamic therapies). Surgical approach is often evaluated by the surgeon case by case, and its choice is influenced by the stage of the tumor and its histology, and therefore survival and even postoperative courses may hardly be compared because patient cohorts are highly different: moreover, as reported by Wolf and colleagues [3], pleurectomy decortication and extrapleural pneumonectomy have different indications and they should not be considered as alternative treatments. Lastly, the definition of pleurectomy and decortication could be considered like a Pandora's box because it contains a great range of lung-sparing surgical approaches, which could change depending on the surgeon's technique [4]. Although this meta-analysis looks at a very interesting and challenging topic, is it really possible and meaningful to compare long-term survival of such a varied population of patients treated with a multimodal set of therapies?
Heart, Jan 6, 2014
Objective Among people with Marfan syndrome who have a typical aortic root aneurysm, dissection i... more Objective Among people with Marfan syndrome who have a typical aortic root aneurysm, dissection is a characteristic cause of premature death. To preempt Type A dissection, composite root replacement with a mechanical valve became the standard of care in the 1980s and 1990s. This is being superseded by valvesparing aortic root replacement to avoid lifelong anticoagulation. In 2004, a total root and valve-sparing procedure, personalised external aortic support, was introduced. We report here results among the first 30 recipients. Methods From cross-sectional digital images, the patient's own aorta is modelled by computer aided design and a replica is made in thermoplastic by rapid prototyping. On this, a personalised support of a macroporous polymer mesh is manufactured. The mesh is positioned around the aorta, closely applied from the aortoventricular junction to beyond the brachiocephalic artery. The operation is performed with a beating heart and usually without cardiopulmonary bypass. Results Between 2004 and 2011, 30 patients, median age 28 years (IQR 20-44) had this operation and have been prospectively followed for 1.4-8.8 years by February 2013. During a total of 133 patient-years there were no deaths or cerebrovascular, aortic or valve-related events. These early outcomes are better than published results for the more radical extirpative root replacement operations. Conclusions The aortic valve, the root architecture, and the blood/endothelia interface are conserved. The perioperative burden is less and there has been freedom from aortic and valvular events. A prospective comparative study is planned.
Journal of integrative cardiology, 2016
Aortic root aneurysm is a characteristic feature of Marfan syndrome and is the commonest cause of... more Aortic root aneurysm is a characteristic feature of Marfan syndrome and is the commonest cause of death in the natural history of this condition. Aortic root replacement, introduced in the 1960s and iteratively developed over the subsequent thirty years dramatically improved the prognosis for people with Marfan syndrome. In 2004 a fundamentally different approach was introduced. Rather than surgical resection of the fibrillin deficient aorta, and its replacement with a fabric tube graft, an external support, custom made to the shape and size of the individual's aortic root, was manufactured in preparation for surgery. At operation this is positioned around the aorta extending proximally to the aorto-ventricular junction and distally to beyond the origin of the brachiocephalic artery. This operation has now been done in over 65 patients, mostly with Marfan syndrome, with 270 patient/years of follow-up. The mesh is soft, pliable and macroporous. Histologically the mesh can be seen to become incorporated in the aortic adventitia with collagen fibres passing through its interstices to form a strong composite neo-aorta without sacrificing the natural blood/endothelial interface and maintaining the natural support of the aortic valve within the sinuses of Valsalva. In this article we concentrate on the collaborations between disciplines which have allowed the development and further investigation of this method. All conclusions at this stage are tentative because the follow-up is not long enough to be fully confidant of the results. At present the best indication for PEARS is early in the progression of the root aneurysm when it offers conservation of the aortic valve and the blood/endothelial interface with the hope of indefinitely minimising the hazards of the aortic root. The clinical problem 'The signature manifestation of cardiovascular pathology in MFS is a grossly dilated aortic root, which commonly results in aneurysm, aortic valve regurgitation, and an increased risk of dissection, rupture, and death; hence, the root is the source of all evil affecting patients with MFS' [1]. This stark summary from one of the USA's leading surgeons specialising in aortic disease is a fair introduction to the problem.
the british journal of cardiology, 2020
Patients with congenitally determined aortic root aneurysms are at risk of aortic valve regurgita... more Patients with congenitally determined aortic root aneurysms are at risk of aortic valve regurgitation, aortic dissection, rupture and death. Personalised external aortic root support (PEARS) may provide an alternative to aortic root replacement.This was a multi-centre, prospective cohort of all consecutive patients who received ExoVasc mesh implants for a dilated aortic root between 2004 and 2017. Baseline and peri-operative characteristics, as well as early postoperative outcomes are described, and time-related survival and re-operation free survival are estimated using the Kaplan-Meier method.From 2004 through 2017, 117 consecutive patients have received ExoVasc mesh implants for aortic root aneurysm. The inclusion criteria were an aortic root/sinus of Valsalva and ascending aorta with asymptomatic dilatation of between 40 and 50 mm in diameter in patients aged 16 years or more. Patients with more than mild aortic regurgitation were excluded. There was one early death. The length of stay was within seven days in 75% of patients.In conclusion, the operation achieves the objectives of valve-sparing root replacement. PEARS may be seen as a low-risk conservative operation, which can be applied earlier on in the disease process, and which is complementary to more invasive procedures, such as valve-sparing root replacement or total root replacement.
Elective surgery is used to safeguard people whose aortic root is affected by Marfan syndrome fro... more Elective surgery is used to safeguard people whose aortic root is affected by Marfan syndrome from the consequences of aortic dissection. 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. These are re-explored to include the latest option: customised external aortic root support.
Personalized External Aortic Root Support (PEARS) surgery was started in 2004 at the Royal Brompt... more Personalized External Aortic Root Support (PEARS) surgery was started in 2004 at the Royal Brompton Hospital, London, and has now been used to treat over 100 patients with asymptomatic aortic dilation related to Marfan Syndrome, Loeys-Dietz Syndrome, Bicuspid Aortic Valve disease, Turner's Syndrome, and various other congenital conditions involving asymptomatic aortic dilation. It retains all of the native structures, but reinforces the aortic root to halt dilation. In this video, PEARS inventor and first patient, Tal Golesworthy, interviews the 100th PEARS patient.Disclosure: Tal Golesworthy is the inventor of PEARS and was the first recipient of a PEARS implant with respect to his own Marfanoid aorta. Mr Golesworthy is a director and shareholder of Exstent, Ltd, which makes the ExoVasc® Personalized External Aortic Root Support.<br>
The Annals of Thoracic Surgery, 2015
the best treatment leading to satisfactory long-term oncologic results has not been found yet. Th... more the best treatment leading to satisfactory long-term oncologic results has not been found yet. The most important thing we learned about treatment of malignant pleural mesothelioma is that surgery plays an important role in cytoreduction, but it cannot be considered alone even in early stage diseases and it must always be associated with other therapies both in a neoadjuvant and adjuvant set [2]. In addition to this, a wide range of therapies may be added during surgery to increase the local control of the disease (intraoperative adjuvant chemotherapy, intrapleural iodine povidone solution, or photodynamic therapies). Surgical approach is often evaluated by the surgeon case by case, and its choice is influenced by the stage of the tumor and its histology, and therefore survival and even postoperative courses may hardly be compared because patient cohorts are highly different: moreover, as reported by Wolf and colleagues [3], pleurectomy decortication and extrapleural pneumonectomy have different indications and they should not be considered as alternative treatments. Lastly, the definition of pleurectomy and decortication could be considered like a Pandora's box because it contains a great range of lung-sparing surgical approaches, which could change depending on the surgeon's technique [4]. Although this meta-analysis looks at a very interesting and challenging topic, is it really possible and meaningful to compare long-term survival of such a varied population of patients treated with a multimodal set of therapies?
The Lancet, 2004
Search by Subject Search using Medical Subject Headings (&lt; b&gt; MeSH&lt;/b&gt... more Search by Subject Search using Medical Subject Headings (&lt; b&gt; MeSH&lt;/b&gt;), a controlled vocabulary for indexing life sciences content.&lt; br/&gt; Note that some records do not have MeSH. These include Patents and the latest PubMed and PubMed Central records.
Interactive cardiovascular and thoracic surgery, 2010
Fatal aortic dissection commonly occurs in Marfan syndrome. Prevention currently relies on electi... more Fatal aortic dissection commonly occurs in Marfan syndrome. Prevention currently relies on elective replacement of the aortic root. We are evaluating the placement of a manufactured, bespoke external support derived from a computer aided design in a prospective study. In the first ten patients, measurements were made consistently of the ascending aorta at the level of closure of the aortic valve cusps from magnetic resonance imaging (MRI) studies taken preoperatively and at fixed intervals thereafter. Before and after images were presented for measurement amongst duplicate images of 37 unoperated Marfan patients to permit assessment of intra-observer measurement reproducibility. All images were presented in random sequence to a radiologist unaware of the research question. The largest difference between the preoperative measurement and that made at least one year after surgery was determined. All patients had surgery as planned without complications and were alive at one year. In ei...
European Journal of Cardio-Thoracic Surgery, 2009
JRSM, 2010
Summary Objectives Fatal aortic dissection occurs at young age in Marfan syndrome. Prevention rel... more Summary Objectives Fatal aortic dissection occurs at young age in Marfan syndrome. Prevention relies on elective replacement of the aortic root. The placement of an external aortic root support, tailored to the anatomy of the individual patient has been proposed as a feasible alternative. Design, setting and main outcome measures External aortic root support was offered to patients with Marfan syndrome with aortic root diameter of 40–55 mm and without aortic regurgitation. By computer-aided design, a model of the individual patient's aorta was created from cardiac magnetic resonance images and a bespoke external aortic support was manufactured. Comparative measurements were made of the ascending aorta at the level of closure of the aortic valve cusps from magnetic resonance imaging studies taken preoperatively, at first follow-up, and at most recent follow-up. For patients having aortic root surgery at the same institution, in the same time frame as the first 10 patients, clinic...
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Papers by Tal Golesworthy