Transaxillary (TAx) access has shown comparable outcomes to transfemoral access in selected studies of transcatheter aortic valve implantation (TAVI). Although TAx-TAVI has mainly been performed via surgical cutdown under general anesthesia, a fully percutaneous approach under local anesthesia with mild sedation has recently emerged as a less invasive option. We present Balloon-Assisted Transaxillary Artery Closure (BATAC) approach and report our early clinical experience. This observational study included consecutive adult patients with severe aortic stenosis who underwent simplified TAx-TAVI. Procedures were performed via left or right axillary access under ultrasound-guidance. Two ProStyles were predeployed, and the access sheath was progressively upsized over Amplatz Super Stiff wire. During closure, the Armada balloon was inflated at 2 atm via the ipsilateral arterial access at the site of the arteriotomy. With the balloon inflated, the ProStyle suture knots were sequentially advanced one-by-one under fluoroscopic guidance all the way to the arterial wall adjacent to the inflated balloon ensuring no entrapment within the surrounding soft tissue. Twelve patients underwent TAx-TAVI using this technique. Technical success was met in all patients, and device success in 91.7%. There were no in-hospital deaths, cerebrovascular events, major vascular complications, life-threatening bleeding, or need for vascular surgery. One patient developed cardiac tamponade requiring pericardial drainage, without transfusion. One minor access-site bleeding episode was managed conservatively. A simplified percutaneous axillary artery closure strategy following TAx-TAVI was associated with excellent early procedural and clinical outcomes in this small cohort. Larger studies are warranted to validate these findings.

BACKGROUND:Transcatheter Aortic Valve Implantation (TAVI) is an effective therapy in patients with severe aortic stenosis presenting in acute heart failure, though whether self-expanding (SEV) or balloon-expandable valves (BEV) should be used in such cases is unknown. The aim of the study is to compare SEV with BEV in such patients. METHODS:Consecutive patients undergoing urgent TAVI with either SEV or BEV at two tertiary hospitals between 2012 and 2024 were studied. The primary endpoint was long-term survival over a median follow-up of 60 months. Secondary endpoints included technical and device success, in-hospital mortality, periprocedural complications, and echocardiographic valve performance. A subgroup analysis evaluated more contemporary devices (after 1/1/2017). RESULTS:A total of 587 patients underwent urgent TAVI [SEV (N = 321) and BEV (N = 266)]. BEV patients had higher rates of prior myocardial infarction and stroke. BEV achieved higher technical and device success, lower in-hospital mortality, and less post-TAVI aortic regurgitation. Although Kaplan-Meier analysis suggested better survival with BEV (log-rank p = 0.017) adjusted Cox regression revealed no significant mortality difference (HR 0.73, 95%CI 0.51-1.04). Outcomes were also comparable in the contemporary device subgroup (n = 299). CONCLUSIONS:To the best of our knowledge, this is the first analysis comparing long-term outcomes in patients presenting in acute heart failure undergoing urgent TAVI between SEV and BEV. No statistically significant difference in long-term survival was observed between SEV and BEV, supporting individualized device selection based on anatomy and operator preference.

Current guidelines recommend single antiplatelet therapy (SAPT) with aspirin for most patients undergoing transcatheter aortic valve implantation (TAVI). However, the optimal choice of SAPT, namely aspirin or clopidogrel, remains uncertain. Our study aims to compare the impact of aspirin versus clopidogrel monotherapy on all-cause mortality in patients after TAVI. Consecutive patients undergoing TAVI treated with single antiplatelet treatment (aspirin or clopidogrel) at two tertiary hospitals between 2012 and 2024 were studied. The primary endpoint was long-term survival over a median follow-up of 49.2 months. Propensity score matching was performed to adjust for baseline differences. Among 982 patients who underwent transcatheter aortic valve implantation and were treated with single antiplatelet therapy, 730 received aspirin, and 252 received clopidogrel. Patients treated with clopidogrel more frequently had a history of ischemic stroke and prior percutaneous coronary intervention and had lower preprocedural peak transvalvular velocity. Overall survival did not differ significantly between patients treated with aspirin and those with clopidogrel (101.0 months [52.7–149.3] versus 88.3 [49.3–127.3], P = 0.390). After propensity score matching, 141 pairs were identified, and long-term survival remained similar between the two groups (108.7 months [54.6–156.8] versus 88.3 [48.5–117.6], P = 0.204). To the best of our knowledge, this is the largest study comparing aspirin versus clopidogrel following TAVI. Our analysis showed comparable long-term survival in patients treated with either aspirin or clopidogrel. Further randomized trials are required for the validation of our results.

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.)

An 83-year-old woman presented 9 years after Tendyne transcatheter mitral valve replacement with acute severe decompensated heart failure. Transesophageal echocardiography reported severe transvalvular mitral regurgitation caused by degenerated Tendyne leaflets. A transfemoral transseptal valve-in-Tendyne procedure using a 26-mm SAPIEN device resulted in significant mitral regurgitation reduction and symptomatic recovery.

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.

An 83-year-old woman presented 9 years after Tendyne transcatheter mitral valve replacement with acute severe decompensated heart failure. Transesophageal echocardiography reported severe transvalvular mitral regurgitation caused by degenerated Tendyne leaflets. A transfemoral transseptal valve-in-Tendyne procedure using a 26-mm SAPIEN device resulted in significant mitral regurgitation reduction and symptomatic recovery.

Although the incidence of papillary muscle rupture (PMr) has declined in line with increasing coronary revascularization, it remains a grave sequela of acute myocardial infarction because of its poor clinical outcomes. The feasibility of gold standard surgical intervention however is often limited by the high operative risk of patients characteristically presenting in extremis with acute pulmonary edema. The SHould we emergently revascularize Occluded Coronaries in cardiogenic shocK (SHOCK) Trial Registry of patients after acute myocardial infarction with cardiogenic shock and new mitral regurgitation (MR) reported only 38% eligibility for mitral valve surgery. 1 Thompson CR Buller CE Sleeper LA Antonelli TA Webb JG Jaber WA Abel JG Hochman JS Cardiogenic shock due to acute severe mitral regurgitation complicating acute myocardial infarction: a report from the SHOCK Trial Registry. Should we use emergently revascularize Occluded Coronaries in cardiogenic shock?. J Am Coll Cardiol. 2000; 36: 1104-1109 Crossref PubMed Scopus (229) Google Scholar Even then the postoperative mortality rate was high at 53% at 30 days. Percutaneous mitral valve intervention has therefore gained increasing recognition as a potential salvage strategy for those with prohibitively high surgical risk. The current evidence base for mitral transcatheter-edge-to-edge repair (M-TEER) for PMr is limited to case reports with immediate and short-term procedural outcomes. We, therefore, describe the first cohort with long-term clinical outcomes after TEER for acute MR secondary to PMr.

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

We describe an unusual presentation of transcatheter mitral valve edge-to-edge repair device embolization into the left common femoral vein in a patient with primary degenerative mitral regurgitation. We hypothesize a possible mechanism for this phenomenon, factors that may increase the risk of this complication, and outline the patient’s clinical course. (Level of Difficulty: Intermediate.)

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.

BACKGROUND:Transcatheter edge-to-edge mitral valve repair (TMVr) improves symptoms and survival for patients with heart failure with reduced left ventricular ejection fraction (HFrEF) and severe secondary mitral regurgitation despite guideline-recommended medical therapy (GRMT). Whether TMVr is cost-effective from a UK National Health Service (NHS) perspective is unknown. METHODS:We used patient-level data from the Cardiovascular Outcomes Assessment of the MitraClip Percutaneous Therapy for Heart Failure Patients with Functional Mitral Regurgitation (COAPT) trial to perform a cost-effectiveness analysis of TMVr +GRMT versus GRMT alone from an NHS perspective. Costs for the TMVr procedure were based on standard English tariffs and device costs. Subsequent costs were estimated based on data acquired during the trial. Health utilities were estimated using the Short-Form 6-Dimension Health Survey. RESULTS:Costs for the index procedural hospitalisation were £18 781, of which £16 218 were for the TMVr device. Over 2-year follow-up, TMVr reduced subsequent costs compared with GRMT (£10 944 vs £14 932, p=0.006), driven mainly by reductions in heart failure hospitalisations; nonetheless, total 2-year costs remained higher with TMVr (£29 165 vs £14 932, p<0.001). When survival, health utilities and costs were projected over a lifetime, TMVr was projected to increase life expectancy by 1.57 years and quality-adjusted life expectancy by 1.12 quality-adjusted life-years (QALYs) at an incremental cost of £21 980, resulting in an incremental cost-effectiveness ratio (ICER) of £23 270 per QALY gained (after discounting). If the benefits of TMVr observed in the first 2 years were maintained without attenuation, the ICER improved to £12 494 per QALY. CONCLUSIONS:For patients with HFrEF and severe secondary mitral regurgitation similar to those enrolled in COAPT, TMVr increases life expectancy and quality-adjusted life expectancy compared with GRMT at an ICER that represents good value from an NHS perspective.