The involvement of Medical Technology (MedTech) corporations in the provision of healthcare is in the spotlight following the introduction of post-Brexit MedTech legislation in the UK. The relationship between surgeons and device sales representatives is especially relevant in cardiac surgery: the use of grafts, stents, prostheses, and other devices is an integral component of most procedures. Many argue that the involvement of device representatives in cardiac surgical cases is valuable – they are often experts on their product, able to contribute their expertise in challenging cases, and help ensure the procedure runs smoothly. Yet, the potential for MedTech corporations to influence surgeons’ clinical decision-making introduces a conflict-of-interest and calls into question what the ‘best practice’ for sales reps should be. The influence of MedTech corporations over policymaking bodies in the UK also represents a major issue for transparency and is equally deserving of evaluation.

Background: The average living age of the population is constantly increasing and so is the incidence and prevalence of aortic valve disease. Surgical aortic valve replacement (SAVR) is the current gold standard treatment. Nevertheless, the use of prosthetic valves in SAVR is associated with issues that impact patients’ quality of life. Aortic valve neocuspidization (AV Neo) offers a means to solve this dilemma by minimising foreign valve tissue. AV Neo can either be performed using glutaraldehyde-treated autologous pericardium (Ozaki procedure) or bovine pericardium (Batista procedure). Aims: This commentary aims to discuss the recent study by Chan and colleagues which highlighted the surgical approach, clinical outcomes and limitations of the Ozaki procedure, and compare this to the Batista procedure. Methods: A comprehensive literature search was performed using multiple electronic databases including PubMed, Ovid, Embase and Scopus in order to collate the relevant research evidence. Results: Although the Ozaki procedure can achieve favourable results whilst mainly avoiding the need for life-long oral anticoagulation with mechanical valves, it still has several limitations that may hinder results. AV Neo using glutaraldehyde-treated bovine pericardium, developed by pioneer cardiac surgeon Dr. Randas J. Vilela Batista, yields superior clinical outcomes to Ozaki’s, including excellent survival, lower complications and minimal need for reoperation as well as shorter operative times. Conclusion: AV Neo offers a means to perform SAVR whilst escaping the prosthetic valve issues. However, the Batista procedure has shown beyond doubt that it can be considered the superior approach for AV Neo over the Ozaki procedure.

Journal of Cardiac SurgeryEditorial

Background The use of thoracic endovascular aortic repair (TEVAR) for the management of uncomplicated type B aortic dissection (un-TBAD) remains controversial. There is a lack of consensus over whether pre-emptive TEVAR should be carried out in patients with un-TBAD at risk of progression to complicated TBAD. We present a review of current evidence and seek to suggest criteria where endovascular intervention in un-TBAD may prove beneficial relative to pharmacotherapy alone. Methods and Materials PubMed and Cochrane databases were searched using terms including: type B aortic dissection, risk factors, medical therapy, TEVAR, false lumen expansion, and mortality. Papers were selected based on title and abstract. Results Optimal medical therapy remains the mainstay treatment for patients with un-TBAD, however patients with un-TBAD present with varying degrees of disease progression risk. Factors such as age, aortic morphology, history of connective tissue disorders, false lumen thrombosis, and aortic branch involvement may potentiate progression from un-TBAD to complicated TBAD. Short- and long-term outcomes associated with TEVAR for TBAD remain promising. Conclusion Pre-emptive TEVAR may be beneficial in patients with un-TBAD presenting with the above factors, however further prospective research into the optimal timing for TEVAR in un-TBAD is required.

We present a reply to the invited commentary by Jubouri and Abdelhaliem published in response to our original article titled: Prevention vs Cure: is BioGlue priming the optimal strategy against E-Vita Neo graft oozing? The authors highlight key issues associated with the E-Vita Open NEO aortic arch prosthesis, chiefly, the propensity for the prosthesis to exhibit post-anastomotic oozing. We read with great interest their commentary and concur that the issues highlighted therein are significant and warrant discussion.

Patients with a bicuspid aortic valve (BAV) are at increased risk of valvular regurgitation compared to their counterparts with a tri-leaflet aortic valve. There is now increasing emphasis to offer BAV repair to mitigate the risks of prosthesis-related complications, including thromboembolism, haemorrhage and endocarditis, as well as structural valve deterioration and future re-operation with conventional valve replacement, particularly in younger populations. Furthermore, over the preceding two decades, our greater understanding of the functional anatomy of the BAV, pathophysiological mechanisms of BAV insufficiency and the development of a functional classification of aortic regurgitation have significantly contributed to the evolution of aortic valve reconstructive surgery. In this commentary, we discuss a recent article from the Journal of Cardiac Surgery comparing external annuloplasty and subcommissural annuloplasty as techniques for BAV repair.

Background Since the introduction of the E-Vita Open NEO aortic prosthesis in 2020, several incidences of post-anastomotic oozing from the polyester portion of the graft have emerged. The use of BioGlue to prime E-Vita Open NEO to prevent this has been suggested as a way to mitigate this worrying complication. We investigate the extent of graft oozing in E-Vita Open NEO and evaluate the use of BioGlue in preventing oozing, both experimentally and in terms of potential clinical complications. Methods and materials E-Vita Open NEO (in straight and branched configurations) was implanted in a perfused model. The distal stent-graft and side branches were clamped, and the graft pressurised with blood to 120 mmHg. The volume of blood (ml) oozing from the graft within 60 seconds was measured. Non-pressurised grafts were coated with BioGlue up to a thickness 1-, 2-, and 3 mm, and the volume (mm3) of BioGlue required to do so was recorded. Results Within 60 seconds, 250.0 ml of blood oozed from the grafts tested. 43.694 mm3, 87.389 mm3, and 174.778 mm3 of BioGlue was required to coat the device with 1-, 2-, and 3 mm of BioGlue. Conclusion Graft oozing from E-Vita Open NEO represents an omnipresent and worrying risk. The use of BioGlue herein is likely associated with several adverse consequences, which are an additional risk on top of that posed by graft oozing. These risks call into question the suitability of E-Vita Open NEO, especially when compared to alternative devices not affected by oozing.

Background: The advent of Frozen elephant trunk (FET) for reconstruction of elective and non-elective aortic arch surgery has augmented the treatment of complex aortic pathologies in a single-stage operation. To date, no studies have been focused on the prevalence and predictors of coagulopathy potentiated by FET procedure. Methods: In a systematic review, we searched databases up to June 2020 for studies reporting coagulopathy complications after FET procedure. A proportional meta-analysis was carried out using STATA software (StataCorp, TX, USA). Results: In total, 46 studies including 6313 patients were eligible. The pooled estimation of reoperation for postoperative bleeding was 7% (95% confidence interval [CI] 5 to 8; I2 = 84.73%; reported by 39 studies including 4796 patients). The mean volume of transfused packed blood cells and fresh frozen plasma was 1677 ml (95% CI 1066.4-2287.6) and 1016.5 ml (95% CI 450.7-1582.3). The subgroup by stent type showed a decrease in the heterogeneity (I2 = 0.01%, I2 = 53.95%, I2 = 0.01%, and I2 = 54.41% for Thoraflex® Hybrid, E-vita®, Frozenix®, and Cronus®, respectively). The subgroup by chronicity of operation resulted in less heterogeneity among patients undergoing elective compared to non-elective operation (I2 = 29.22% versus I2 = 80.56% in non-elective). Meta-regression analysis showed that age and male gender significantly impacted on the reoperation for postoperative bleeding. Conclusions: The FET procedure for arch replacement is associated with coagulopathy and the transfusion of blood products. Male, age, and selective choice of FET use were identified as heterogeneity sources of reoperation for postoperative bleeding.

Much has changed since the introduction of surgical valve repair in the 1950s, from the introduction bioprosthetic valves to percutaneous approaches to valve repair. Yet, despite substantial advancements in bioprosthetic valve technology, there has been a lack of direct, independent comparison between bioprosthetic mitral valve devices, accompanied by a marked heterogeneity in approaches to the sizing and selection thereof. Wang et al. have hence endeavoured to evaluate, head-to-head, the technical successes and biomechanical outcomes associated with three different bioprosthetic mitral valves (Epic, Abbott, IL; Mosaic, Medtronic, MN; Mitris Resilia, Edwards Lifesciences, CA) in a porcine model, under standardised haemodynamic and anatomical conditions. With a robust experimental technique, they have made clear the heterogeneity in both sizing and biomechanical properties between bioprosthetic mitral valves, and have further emphasised the need for a uniform approach to the manufacturing and sizing of bioprosthetic valves.

ABSTRACT The involvement of Medical Technology (MedTech) corporations in the provision of surgical care remains a topic of debate. This relationship is especially relevant in cardiac and aortic surgery as the use of grafts, stents, prostheses, and other devices is an integral component of most procedures. Many argue that the involvement of device representatives in cardiac surgical cases is valuable – they are often experts on their product and are able to contribute their expertise in challenging cases. Yet, the potential for MedTech corporations to influence surgeons’ clinical decision-making introduces a conflict-of-interest and calls into question what the ‘best practice’ for sales reps should be. The influence of MedTech corporations over policymaking bodies in the US, UK, and Europe also represents a major issue for transparency and is equally deserving of evaluation.

Background Paget-Schroetter Syndrome (PSS) is an uncommon disorder involving thrombosis of the subclavian vein, often caused by repetitive overuse or compression by the surrounding anatomical structures. Optimal management of PSS is a subject of debate, but current trends suggest that a hybrid approach employing endovascular intervention and open decompression may yield the best clinical results. This original article examines the roles played by endovascular thrombolysis, surgical decompression, and postoperative secondary intervention in the management of PSS. Methods Current literature on the management of PSS was reviewed and evaluated to ascertain what strategy of intervention would be optimal. In addition, clinical data from the University Hospital of Wales on the clinical outcomes in PSS patients undergoing different surgical approaches for anatomical decompression are included. Results Evaluation of data from the included series and available literature seems to indicate that endovascular thrombolytic devices such as the AngioJet or mechanical thrombectomy offer superior results than traditional catheter-directed thrombolysis. In addition, adjunctive procedures such as superior vena cava filters and venous angioplasty or bypass may augment maintenance of the subclavian vein lumen. Nonetheless, the subclavian vein must still be relieved of pressure from surrounding structures for treatment to be successful. Conclusions A hybrid approach to the management of PSS, encompassing endovascular and surgical interventions could possibly offer optimal clinical outcomes as both intrinsic lesions and extrinsic compression of the subclavian vein are resolved. This article recommends prospective research to determine the ideal endovascular treatment, and best surgical approach for decompression.

Background Use of the Frozen Elephant Trunk (FET) device to manage complex surgical pathologies of the aorta (e.g. acute Type A aortic dissection) has gained popularity since its introduction in the early 2000s. Though the distal anastomosis was traditionally performed at Zone 3 (Z-3-FET), preference gradually shifted towards Zone 2 (Z-2-FET) in favour of improved surgical access and outcomes. This review seeks to elucidate whether proximalisation of arch repair to Zone 0 (Z-0-FET) would further improve postoperative outcomes. Methods We performed a review of available literature to evaluate the comparative efficacies of Z-2-FET versus Z-0-FET, in terms of surgical technique, clinical outcomes, and incidence of adverse events. Results Z-0-FET seems to be associated with a more accessible surgical approach, and shorter cardiopulmonary bypass, antegrade cerebral perfusion, and cardioplegia durations than Z-2-FET. Further, Z-0-FET is could potentially be associated with a lower incidence of neurological, renal, and recurrent laryngeal nerve injury, as well as mortality and reintervention rates than Z-2-FET. This said, Z-0-FET is itself associated with significant challenges, and efficacy in terms of postoperative true lumen integrity and false lumen thrombosis is mixed. Conclusion Current literature seems to suggest that Z-0-FET procedures are more straightforward and associated with lower rates of certain adverse events, however, the majority of data reviewed is retrospective. This review therefore recommends prospective research into the comparative strengths and limitations of Z-0-FET and Z-2-FET to better substantiate whether proximalisation of arch repair represents a concept, or a true challenge to advance surgical intervention for arch pathologies.