Background ST-segment elevation myocardial infarction (STEMI) is treated with immediate primary percutaneous coronary intervention (pPCI) to restore coronary blood flow in the acutely ischaemic territory, but is associated with reperfusion injury limiting the benefit of the therapy. No treatment has proven effective in reducing reperfusion injury. Transcoronary hypothermia has been tested in clinical studies and is well tolerated, but is generally established after crossing the occlusion with a guidewire therefore after initial reperfusion, which might have contributed to the neutral outcomes. Transcatheter strategies may also offer additional benefit through haemodilution and the resultant controlled reperfusion, but this has not been fully investigated for pPCI. Design STEMI-Cool is a pragmatic, registry-based randomised clinical pilot trial to test the recruitment rate, feasibility, and safety of a simple transcoronary cooling and dilution protocol. Sixty STEMI patients undergoing pPCI will be randomised 1:1 to standard of care or continuous infusion of room temperature saline through the guiding catheter to achieve intracoronary temperature reductions of 6 to 8 degrees C, commencing before crossing the coronary occlusion with a guidewire. Mechanistic outcome measures will include microvascular resistance, biomarkers of inflammation before infusion and at 24 hour, and magnetic resonance imaging of myocardial salvage and infarct size. Conclusions STEMI-Cool will investigate the recruitment rate, feasibility and safety of an innovative and simple cooling and diluting strategy for cardioprotection before and during reperfusion with pPCI, aiming to address limitations faced in other studies. Mechanistic outcome measures will allow insight into inflammatory, microvascular and structural changes induced by transcoronary cooling and dilution. (Am Heart J 2025;282:40-50.)

Aims Transcatheter aortic valve implantation (TAVI) is an alternative to surgical aortic valve replacement for patients with aortic valve stenosis. The choice between TAVI, surgery, or a conservative approach should be based upon multiple factors including clinical considerations, technical feasibility, and informed patient preference. In this context, engaging patients in a shared decision-making (SDM) process becomes essential, but this practice is generally underused. Methods and results To comply with the European and UK national guidelines, in January 2023 we established a structured SDM pathway in which patients are offered virtual/physical decision aids and after 1 week are invited to a meeting to reach a shared decision. From December 2022 to June 2023, a custom-developed questionnaire was prospectively administered to 23 patients prior to, and 38 patients after, the implementation of the SDM pathway. The answers to 12 core questions were recorded on a Likert scale (1-5). Global satisfaction, as measured by mean Likert score, was significantly higher for the post-SDM group than for the pre-SDM group (4.46 +/- 0.14 vs. 3.78 +/- 0.30, P < 0.001). The percentage of positive (Likert 4-5) responses was significantly higher in the post-SDM group (289/312, 92.6% vs. 155/234, 66.2%, P < 0.001). The percentage of negative (Likert 1-2) responses was significantly lower in the post-SDM group (5/312, 1.6% vs. 53/234, 22.6%, P < 0.001). Conclusion The SDM pathway proved effective in delivering SDM in compliance with national and international guidance. A similar approach leveraging digital technology to minimize cost and enhance patient convenience could be implemented for other treatments and across other institutions.

Introduction Shared decision making (SDM) is a collaborative process empowering patients and healthcare professionals to engage in discussion around treatment goals and options (National Institute of Health and Care Excellence (NICE), 2023). This framework has long been promoted by NICE, but with limited implementation in practice. Methods We have implemented and evaluated initial experience of a formal SDM meeting integrated into our institutional Transcatheter Aortic Valve Implantation (TAVI) pathway. The meeting was structured to address all of the essential and enhanced standards in the NICE SDM framework and undertaken by a clinical nurse specialist. A questionnaire was developed across selected domains (Figure 1) using the Likert scale and based on NICE guidance, Patient Record Standards Body criteria, and SDM Q-9. Scale: 1/2=Completely/Strongly disagree, 3=Neutral, 4/5 = Completely/Strongly agree. The questionnaire was administered to cohorts of post-TAVI patients before and after the implementation of the SDM program. The ‘global satisfaction score’ (GSS) was computed using the raw scores from all questions answered by all patients before and after SDM. This was compared via the Kruskal-Wallis test. In addition, we aimed to report high and low Likert scores for the individual question domains before and after implementing the SDM pathway. Results There were a total of 30 respondents: 20 in the pre-SDM group, and 10 in the post-SDM group for all 12 question domains. 37% of respondents were female and the age range was 55-90 years. 30% reported a mobility difficulty, 20% hearing loss, 30% no disability and 20% did not specify. There was a significant improvement in the ‘global satisfaction score’ of patient satisfaction following the SDM implementation (median GSS 4 (IQR 3-4) vs 4 (4-5), p<0.001, Figure 1). Furthermore, positive responses increased, and negative responses decreased for all question domains (Figure 2). Conclusion We successfully implemented an SDM meeting into our TAVI pathway. Data collection continues, however our initial experience in this small number of patients suggests that this approach appears to significantly improve positive decision-making outcomes. These include patient involvement, discussion around treatment options and their risks, the opportunity to ask questions, and a reduction in negative responses when compared to patients who did not have an SDM meeting. SDM collaboration is widely applicable throughout clinical decision-making and has the potential to increase patient engagement in their management. Conflict of Interest None

Valve embolization during transcatheter aortic valve implantation is a rare but potentially fatal complication of first generation transcatheter valves. As a result, second generation valves were designed to be fully retrievable and minimize this complication. We report a first case of embolization with a second-generation fully-retrievable and repositionable Lotus valve. In this case, the presence of severe left ventricular hypertrophy and a sigmoid septum may have contributed to prosthesis embolization with the initial 23 mm Lotus valve. With the high implantation we performed with the 23 mm Lotus valve, the septal bulging may have interfered with the high implanted Lotus valve, resulting in the "watermelon seeding" phenomenon, whereby the sigmoidal septum squeezes the valve out of place distally, in spite of the initial appearance of stability. With the 25 mm Lotus valve, the lower implantation height, and the prosthesis oversizing, with greater radial strength, ensured greater stability of the valve.This case highlights the importance of meticulous pre-TAVI assessment of subvalvular geometry, irrespective of the use of newer devices that are repositionable and retrievable. The identification of severe hypertrophy in the subvalvular landing zone should be incorporated into the decision-making process with the possible selection of a self-expanding prosthesis and/or a lower implantation height of an over-sized prosthesis with the Lotus valve to ensure greater valve stability whilst accepting the higher likelihood of the requirement for permanent pacemaker implantation.

Background/Aims Most transcatheter aortic valve implantation procedures are now performed under conscious sedation, rather than general anaesthetic. This study evaluated nurse-led conscious sedation, compared with anaesthetist-led sedation, to determine the feasibility of the former. Methods Consecutive patients undergoing transcatheter aortic valve implantation under either nurse-led or anaesthetist-led sedation between July 2018 and September 2021 were reviewed. Assessed outcomes were analysed and compared, including 30-day mortality rate, major vascular access site bleeding, moderate or severe aortic regurgitation, stroke, new pacemaker implantation, duration of procedure and length of stay. Results A total of 212 patients who underwent nurse-led sedation and 412 who underwent anaesthetist-led sedation were identified. There were no significant differences in risk scores between the two groups. In both groups, incidence of conversion to general anaesthetic was low, with nurse sedatitionists seeking anaesthetist support in 13 (6.2%) cases. Cases with nurse-led sedation had a significantly lower average duration of the procedure (90 minutes vs 111 minutes; P=0.001) and length of stay (2 days vs 3 days, P=0.0002). Conclusions Nurse-led sedation can be safely incorporated into transcatheter aortic valve implantation practice. Nurse-led sedation delivered similar outcomes to anaesthetist-led sedation, but with shorter procedural times and legnth of stay. This could allow more flexible scheduling, increased capacity and improved access for patients.