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In the document we come up with a first approach to identify synergies amongst Tasks 5.1 ‘Market and stakeholder needs analysis’ (Leader: UKOLN) and WP3 (Leader: KINNO) and all its encompassing Tasks. Our aim is to design a lean scheme for the Service Offer, that its value will be demonstrated with a respective ‘storylines’ that will help build the regional ecosystems. To this we make a start in the document by providing insights of the ecosystems in Porto and Cologne. In the next version we shall include also information on the Thessaloniki ecosystem and elaborate for the other two ecosystems as well.

Background Mitral paravalvular leaks (mPVL) are a recognized complication for patients with mitral valve prostheses. Although clinically insignificant for many patients, it may pose life-threatening haemolysis and regurgitation-induced heart failure, and so clinicians should have a high index of suspicion in the presence of new symptoms. Aims This review discusses the pathogenesis, clinical features, diagnosis, imaging and treatment of mPVLs. Methods A comprehensive literature search was performed using PubMed, EMBASE, Cochrane database, Google Scholar and Ovid. Search terms used included "mitral valve paravalvular leak," "transthoracic echocardiography," "2D transoesophageal echocardiography," "3D transoesophageal echocardiography," "cardiac computed tomography," (CT) "cardiac magnetic resonance imaging," "intracardiac echocardiography," "cinefluoroscopy," "fluoroscopy," and "percutaneous closure." Results All patients with mPVLs should undergo regular full evaluation, including patient history, physical examination, laboratory work-up, imaging, and referral, if necessary. Echocardiography is fundamental to the diagnosis, and is augmented with cardiac magnetic resonance imaging, cardiac computerized tomography and fluoroscopy for further characterization and procedural planning amongst the structural heart team. Conclusion The prevalence of mPVL is expected to increase proportionally to the growing number of surgical and transcatheter valve replacements conducted in the ageing population. Multimodal imaging is instrumental in guiding diagnostic and therapeutic strategies when managing mPVLs. Advances in imaging and capabilities of transcather devices will prompt growing uptake of percutaneous treatment over conventional, higher-risk surgery for mPVL management.

Aortic dissection (AD) is a life-threatening medical emergency that affects an estimated 3-4 people per 100,000 annually, with 40% of cases classified as type B AD (TBAD). TBAD can be further classified as being complicated (co-TBAD) or uncomplicated (un-TBAD) based on the presence or absence of certain features such as malperfusion and rupture. TBAD can be managed conservatively with optimal medical therapy (OMT), or invasively with open surgical repair (OSR) or thoracic endovascular aortic repair (TEVAR), depending on several factors such as type of TBAD and its clinical acuity. The cost-effectiveness, or cost-benefit profile, of these strategies must be given equal consideration. However, TBAD studies featuring cost analyses are limited within the literature. This narrative review aims to address the gap in the literature on cost-effectiveness of TBAD treatments by providing an overview of cost analyses comparing OMT with TEVAR in un-TBAD and TEVAR with OSR in co-TBAD. Another aim is to provide a market analysis of the commercially available TEVAR devices.A comprehensive literature search was performed using several search engines including PubMed, Ovid, Google Scholar, Scopus, and Embase to identify and extract relevant studies.Several TEVAR devices are available commercially on the global market costing $12,000-19,495. Nevertheless, the Terumo Aortic RELAY® stent graft seems to be the most cost-effective, yielding highly favourable clinical outcomes. Despite the higher initial cost of TEVAR, evidence in the literature strongly suggest that it is superior to OMT for un-TBAD on the long-term. In addition, TEVAR is well established in the literature as being gold-standard repair technique for co-TBAD, replacing OSR by offering a more optimal cost-benefit profile through lower costs and improved results.The introduction of TEVAR has revolutionized the field of aortovascular surgery by offering a highly efficacious and long-term cost-effective treatment for TBAD.

Background: Hepatitis B virus (HBV) remains endemic in South Africa (SA), with a concomitantly high prevalence of HIV co-infection. Chronic kidney disease in these subpopulations also has a high prevalence. Tenofovir is an important component of management, but the associated risk of nephrotoxicity makes dosing a challenge in patients with impaired kidney function. A new formulation, tenofovir alafenamide fumarate (TAF), with a more favourable renal toxicity profile, is now available. Objectives: To evaluate our initial experience of TAF use at Groote Schuur Hospital, Cape Town. Methods: We retrospectively reviewed patients with HBV mono-infection and HIV-HBV co-infection who were initiated on TAF since 2018. We recorded all relevant demographic, serological, virological and biochemical data from patient records. Adherence was documented by pill collection at the pharmacy. Results: A total of 26 patients were included in the evaluation, median (interquartile range (IQR)) age 48 (39 - 51) years, 73% (n=19) male, 27% (n=7) hepatitis B e-antigen-positive, and 46% (n=12) HIV co-infected. The median (IQR) duration of treatment with TAF was 13 (9 - 15) months. The median (IQR) baseline creatinine level was 180 (130 - 227) μmol/L, with significant improvement at 12 months, 122 (94 - 143) μmol/L; p=0.017. Reflecting this change, the estimated glomerular filtration rate improved significantly from baseline to month 12 (42 (25 - 52) and 51 (48 - 68) mL/min/1.73 m2, respectively; p=0.023). Similarly, serum alanine aminotransferase (ALT) normalised from a baseline of 33 (18 - 52) to 18 (15 - 24) U/L at month 12 (p=0.012). HBV DNA viral load also declined, from a baseline of log10 4.04 (2.5 - 7.8) IU/mL to a median of

Frozen elephant trunk (FET) has in recent times become a mainstay for total arch replacement (TAR) in aortovascular surgery and is indicated in order to treat a spectrum of complex aortic pathologies. However, despite associated excellent post-operative results it is incredibly important to recognise potential adverse complications such as negative aortic remodelling, endoleak and distal stent-graft induced new entry so that outcomes can be further improved. Below we provide commentary on a recent article in the Journal of Cardiac Surgery discussing the topic. Despite the fascinating outcomes of this systematic review and meta-analysis the heterogeneity of the literature regarding these adverse outcomes remains an issue which can only be solved with large multi-centre trials directly comparing graft types as well as indications for surgery.

The introduction of the single-step hybrid frozen elephant trunk (FET) procedure for total arch replacement has revolutionized the field of aortovascular surgery. FET has proven to achieve excellent results in the repair of complex thoracic aorta pathologies. However, there remains a risk of reintervention post-FET for a variety of causes. This secondary intervention can either be performed endovascular, with thoracic endovascular aortic repair (TEVAR), or via open surgery. Multiple FET hybrid prosthesis are commercially available, each requiring different rates of endovascular reintervention. The current review will focus on providing an overview of the reintervention rates for main causes in relation to the FET grafts on the market. In addition, strategies to prevent reintervention will be highlighted. A comprehensive literature search was conducted on multiple electronic databases including PubMed, Ovid, Scopus and Embase to highlight the evidence in the literature on endovascular reintervention after FET. The main causes for secondary intervention are distal stent graft-induced new entry (dSINE), endoleak and negative aortic remodeling, and to a much lesser extent, graft kinking and aorto-esophageal fistulae. In addition, it is clear that the Thoraflex Hybrid (Terumo Aortic, Inchinnan, UK) is the superior FET device, showing excellent reintervention rates for all the above causes. Interestingly, the choice of FET device as well as its size and length can help prevent the need for reintervention. The FET procedure is indeed associated with excellent clinical outcomes, however, the need for reintervention may still arise. Importantly, the Thoraflex Hybrid prosthesis has shown excellent results when it comes to endovascular reintervention. Finally, several strategies exist that can prevent reintervention.

Background Uncomplicated type B aortic dissection (unTBAD) comprises the estimated majority of type B aortic dissection (TBAD), presenting without any of the complications associated with complicated TBAD (coTBAD). Although first-line treatment for coTBAD is thoracic endovascular aortic repair (TEVAR), and despite the fact that TEVAR has proven its safety and effectiveness in the treatment of unTBAD, unTBAD is still being predominantly managed conservatively with medical therapy, with a small proportion of patients being offered TEVAR. Aims The main scope of this review is to highlight the evidence in the literature of the demographic characteristics and associated co-morbidities of unTBAD patients undergoing TEVAR in order to produce a risk stratification system to achieve favourable outcomes. Methods A comprehensive literature search was conducted using multiple electronic databases including PubMed, Ovid, Scopus, and EMBASE. Results Multiple demographic characteristics and associated co-morbidities of unTBAD patients affecting TEVAR outcomes were identified, assessed, and investigated, including age, gender, race, genetics, medical conditions, such as hypertension and diabetes, and lifestyle factors such as smoking. Most factors were associated with increased risks of mortality and morbidity, while others, such as race, were identified as being protective against those when it comes to TEVAR. Conclusion Despite the favourable results yielded by TEVAR in unTBAD, there remains a grey area concerning its management. Thus, it is important to incorporate the demographics and co-morbidities of unTBAD patients’ when into clinical judgement when assessing indications for TEVAR intervention to ensure optimum results can be achieved.

Background: There is emerging evidence to support pre-emptive thoracic endovascular aortic repair (TEVAR) intervention for uncomplicated type B aortic dissection (unTBAD). Pre-emptive intervention would be particularly beneficial in patients that have a higher baseline risk of progressing to complicated TBAD (coTBAD). There remains debate on the optimal clinical, laboratory, morphological and radiological parameters which would identify the highest-risk patients that would benefit most from pre-emptive TEVAR. Aim: This review summarises evidence on the clinical, laboratory, and morphological parameters that increase the risk profiles of unTBAD patients. Methods: A comprehensive literature search was carried out on multiple electronic databases including PubMed, EMBASE, Ovid and Scopus in order to collate all research evidence on the the clinical, laboratory, and morphological parameters that increase the risk profiles of unTBAD patients Results: At present, there are no clear clinical guidelines using risk-stratification to inform the selection of unTBAD patients for TEVAR. However, there are noticeable literature trends that can assist with the identification of the most at-risk unTBAD patients. Patients are at particular risk when they have refractory pain and/or hypertension, elevated C-reactive protein (CRP), larger aortic diameter and larger entry tears. These risks should be considered alongside factors that increase the procedural risk of TEVAR to create a well-balanced approach. Advances in biomarkers and imaging are likely to identify more pertinent parameters in future to optimise the development of balanced, risk-stratified treatment protocols. Conclusion: There are a variety of risk profiling parameters that can be used to identify the high-risk unTBAD patient, with novel biomarkers and imaging parameter emerging. Longer-term evidence verifying these parameters would be ideal. Further randomized controlled trials and multicentre registry analyses are also warranted to guide risk-stratified selection protocols.

There is emerging evidence to support pre-emptive thoracic endovascular aortic repair (TEVAR) intervention for uncomplicated type B aortic dissection (unTBAD). Pre-emptive intervention would be particularly beneficial in patients that have a higher baseline risk of progressing to complicated TBAD (coTBAD). There remain debate on the optimal clinical, laboratory, morphological, and radiological parameters, which would identify the highest-risk patients that would benefit most from pre-emptive TEVAR.This review summarizes evidence on the clinical, laboratory, and morphological parameters that increase the risk profiles of unTBAD patients.A comprehensive literature search was carried out on multiple electronic databases including PubMed, EMBASE, Ovid, and Scopus to collate all research evidence on the clinical, laboratory, and morphological parameters that increase the risk profiles of unTBAD patients RESULTS: At present, there are no clear clinical guidelines using risk-stratification to inform the selection of unTBAD patients for TEVAR. However, there are noticeable literature trends that can assist with the identification of the most at-risk unTBAD patients. Patients are at particular risk when they have refractory pain and/or hypertension, elevated C-reactive protein (CRP), larger aortic diameter, and larger entry tears. These risks should be considered alongside factors that increase the procedural risk of TEVAR to create a well-balanced approach. Advances in biomarkers and imaging are likely to identify more pertinent parameters in the future to optimize the development of balanced, risk-stratified treatment protocols.There are a variety of risk profiling parameters that can be used to identify the high-risk unTBAD patient, with novel biomarkers and imaging parameters emerging. Longer-term evidence verifying these parameters would be ideal. Further randomized controlled trials and multicentre registry analyses are also warranted to guide risk-stratified selection protocols.

Background Up to a quarter of inpatients in high-income countries self-report beta-lactam allergy (BLA), which if incorrect, can increase use of alternative antibiotics that impact on bacterial resistance.. The epidemiology of BLA in low- and middle-income African countries is unknown. Methods Point-prevalence surveys were conducted at seven hospitals (adult, pediatric, government and private-funded, district- and tertiary-level) in Cape Town, South Africa between April 2019 and June 2021. Ward prescription records and interviews were conducted to identify BLA patients. De-labeling was attempted at the tertiary allergy clinic at Groote Schuur hospital. Findings A total of 1486 hospital inpatients were surveyed (1166 adults; 308 children). Only 48 (3.2%) patients self-reported a BLA with a higher rate amongst private- versus government-funded hospitals [6.3% vs 2.8%, p=0.014]. Using the PEN-FAST tool, only 10.4% (5/48) of self reported BLA patients were classified as high risk for true penicillin hypersensitivity. Antibiotics were prescribed to 70.8% (34/48) of self reported BLA patients, with 64.7% (22/34) receiving a beta-lactam. Despite three attempts to contact patients for de-labelling at the allergy clinic, only 3/36 underwent in vivo testing, with no positive results and one patient proceeded toa negative oral challenge. Interpretation Unlike high-income countries, self-reported BLA is low amongst inpatients in South Africa. The majority of self-reported BLA were low risk for type 1 hypersensitivity, but out-patient de-labeling efforts were largely unsuccessful. Funding None

Hepatitis B virus (HBV) remains endemic in South Africa (SA), with a concomitantly high prevalence of HIV co-infection. Chronic kidney disease in these subpopulations also has a high prevalence. Tenofovir is an important component of management, but the associated risk of nephrotoxicity makes dosing a challenge in patients with impaired kidney function. A new formulation, tenofovir alafenamide fumarate (TAF), with a more favourable renal toxicity profile, is now available.To evaluate our initial experience of TAF use at Groote Schuur Hospital, Cape Town.We retrospectively reviewed patients with HBV mono-infection and HIV-HBV co-infection who were initiated on TAF since 2018. We recorded all relevant demographic, serological, virological and biochemical data from patient records. Adherence was documented by pill collection at the pharmacy.A total of 26 patients were included in the evaluation, median (interquartile range (IQR)) age 48 (39 - 51) years, 73% (n=19) male, 27% (n=7) hepatitis B e-antigen-positive, and 46% (n=12) HIV co-infected. The median (IQR) duration of treatment with TAF was 13 (9 - 15) months. The median (IQR) baseline creatinine level was 180 (130 - 227) µmol/L, with significant improvement at 12 months, 122 (94 - 143) µmol/L; p=0.017. Reflecting this change, the estimated glomerular filtration rate improved significantly from baseline to month 12 (42 (25 - 52) and 51 (48 - 68) mL/min/1.73 m2, respectively; p=0.023). Similarly, serum alanine aminotransferase (ALT) normalised from a baseline of 33 (18 - 52) to 18 (15 - 24) U/L at month 12 (p=0.012). HBV DNA viral load also declined, from a baseline of log10 4.04 (2.5 - 7.8) IU/mL to a median oflt;log10 1.3 IU/mL at month 12. HIV viral load was less than the lower level of quantification at months 6 and 12.TAF was well tolerated, with stable and significantly improving kidney function throughout a 12-month follow-up period. Serum ALT normalised, mirrored by declining HBV viral load. HIV viral load remained undetectable at 6 and 12 months.

Background:Vocal cord palsy is one of the recognised complications of complex cardiac surgery in the paediatric population. While there is an abundance of literature highlighting the presence of this complication, there is a scarcity of research focusing on the pathophysiology, presentation, diagnosis, and treatment options available for children affected by vocal cord palsy.Materials and methods:Electronic searches were conducted using the search terms: “Vocal Cord Palsy,” “VCP,” “Vocal Cord Injury,” “Paediatric Heart Surgery,” “Congenital Heart Surgery,” “Pediatric Heart Surgery,” “Vocal Fold Movement Impairment,” “VFMI,” “Vocal Fold Palsy,” “PDA Ligation.” The inclusion criteria were any articles discussing the outcomes of vocal cord palsy following paediatric cardiac surgery.Results:The two main populations affected by vocal cord palsy are children undergoing aortic arch surgery or those undergoing PDA ligation. There is paucity of prospective follow-up studies; it is therefore difficult to reliably assess the current approaches and the long-term implications of management options.Conclusion:Vocal cord palsy can be a devastating complication following cardiac surgery, which if left untreated, could potentially result in debilitation of quality of life and in severe circumstances could even lead to death. Currently, there is not enough high-quality evidence in the literature to aid recognition, diagnosis, and management leaving clinicians to extrapolate evidence from adult studies to make clinical judgements. Future research with a focus on the paediatric perspective is necessary in providing evidence for good standards of care.