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COMPLEX PCI 2025

A Practical Strategy for Calcified Coronary Lesions

At COMPLEX PCI 2025, a dedicated workshop on High-Risk PCI and Calcification focused on one of the most critical challenges in contemporary coronary intervention: severe coronary calcification. In the session titled “Cracking the Barrier: Calcium as the Main Obstacle to Successful PCI,” Antonio Colombo, MD (EMO GVM Centro Cuore Columbus, Italy), presented his practical approach to managing calcified coronary lesions. He emphasized that procedural success in calcified lesions depends not on procedural complexity, but on a structured, imaging-guided algorithm and disciplined device selection. Core Devices in Daily Practice Despite the availability of multiple plaque-modifying technologies, he highlighted that real-world practice relies primarily on a limited number of tools. In his experience, more than 90% of calcified lesions can be managed using non-compliant balloons (including super–high-pressure balloons), cutting or scoring balloons, intravascular lithotripsy (IVL), rotational atherectomy and orbital atherectomy. Imaging-Guided Decision Making The cornerstone of his strategy is early intravascular imaging. When calcification is identified on angiography, IVUS or OCT is performed whenever possible. If imaging catheters fail to cross the lesion, rotational atherectomy is promptly adopted, typically using a 1.5–2.0 mm burr, without unnecessary delay. When imaging confirms severe calcification, the choice between rotational atherectomy, IVL, or balloon-based strategies is guided by lesion morphology and vessel characteristics. Calcified nodules require special caution, as aggressive high-pressure balloon dilatation may increase the risk of vessel rupture. In such cases, atherectomy or IVL is preferred when anatomically suitable. A high-pressure non-compliant balloon is routinely used as a final step in lesion preparation. Repeat IVUS or OCT is mandatory to confirm adequate calcium modification. Stenting or drug-coated balloon (DCB) therapy should only be performed after satisfactory imaging results, as implanting a stent in a suboptimally prepared lesion was strongly discouraged. Key Messages He concluded that rotational atherectomy remains the dominant technique for severe coronary calcification, while IVL should be used liberally when available. High-pressure and cutting balloons continue to play an essential role. Above all, intravascular imaging is indispensable—without imaging, optimal treatment of calcified coronary lesions is not achievable. Workshop 5: High-Risk PCI and Calcification Thursday, November 27, 3:30 PM ~ 5:00 PM Main Arena Watch Session Video

December 24, 2025 537

COMPLEX PCI 2025

CTO PCI in 2025: Who Truly Benefits?

At COMPLEX PCI 2025, Ho Lam, MD, FHKAM (Tuen Mun Hospital, Hong Kong, China), challenged attendees to rethink the risks and rewards of Chronic Total Occlusion (CTO) interventions. Presenting a harrowing case of a "Triple CTO," he argued that the question "Who truly benefits?" is best answered not just by randomized data, but by the operator’s ability to master clinical judgment, skills, and device usage to ensure patient safety. The ‘Beast’ of Flow Equilibrium He introduced a case involving a 56-year-old male smoker with a history of hypertension. The patient presented with a severely depressed left ventricular ejection fraction of 20% and a history of cerebrovascular accident due to an LV thrombus. Angiography revealed a daunting "Triple Total" occlusion affecting the LAD, LCX, and RCA. The procedure utilized Impella support to manage the patient's fragile hemodynamics. The team employed a parallel wiring strategy, but after successfully crossing the lesion and opening with a small balloon, the patient experienced a sudden hemodynamic collapse. The culprit was a phenomenon he identified as "Flow Equilibrium." He explained that in critical triple-vessel disease, the heart relies on a delicate balance of collateral supply. By opening the CTO, the antegrade pressure and retrograde pressure equalized, causing a stagnation of flow that led to immediate cardiac arrest, despite the absence of structural complications like perforation or dissection. He illustrated that to break this equilibrium, the operator must speed up the vascularization. The team quickly deployed a stent to increase the antegrade flow force, allowing it to overpower the retrograde resistance and restore perfusion. As predicted, once the stent was placed and the balloon deflated, antegrade flow took over, and blood pressure normalized immediately. Clinical Outcomes Over Randomized Debates The result of the procedure validated the high-risk intervention. Follow-up imaging showed the patient’s ejection fraction improved significantly from a pre-procedural 23% to 40%, with the patient returning to NYHA Class I status. He concluded his lecture by urging interventionalists to "jump out" of the debate regarding randomized data and focus on internal improvement. He outlined three areas that must be developed for successful CTO PCI: Thinking & Clinical Judgment (法): Selecting the right patient and strategy. Skill & Device (術, 器): Utilizing tools like Impella and advanced wiring techniques proficiently. Approach (道): The "Way" to successful revascularization. "Just skill is not enough," he said. "Without the device, without the MCS support, the patient dies hard. Can we do the procedure better so that the patient can get benefit, no failure, no complication? That is the true question." Workshop 4: CTO Thursday, November 27, 2:20 PM ~ 3:30 PM Main Arena Watch Session Video

December 24, 2025 511

COMPLEX PCI 2025

OCTIVUS Trial: OCT- vs. IVUS-Guidance in All-Comer PCI

At COMPLEX PCI 2025, during Workshop 3: Imaging & Physiology, Do-Yoon Kang, MD, PhD (Asan Medical Center, Korea), presented the results of the OCTIVUS Trial, a large-scale randomized study comparing optical coherence tomography (OCT)–guided PCI with intravascular ultrasound (IVUS)–guided PCI in an all-comer population. Intracoronary Imaging: Entering the Class I Recommendation Era He noted that intracoronary imaging has become a central component of contemporary PCI practice. He added that recent clinical guidelines have elevated imaging-guided PCI to a Class I recommendation in several clinical scenarios, including complex lesions and left main disease. Comparison Between OCT and IVUS He explained that optical coherence tomography (OCT) and intravascular ultrasound (IVUS) offer distinct advantages and should be regarded as complementary tools. According to his presentation, OCT provides exceptionally high-resolution visualization of luminal and stent structures, making it particularly valuable for identifying in-stent restenosis and calcified lesions. In contrast, he noted that IVUS allows deeper penetration into the vessel wall and is better suited for the assessment of chronic total occlusions, left main disease, and especially ostial lesions. Overview of the OCTIVUS Trial He then outlined the design of the OCTIVUS trial, describing it as a large-scale, investigator-initiated, pragmatic randomized controlled trial comparing OCT-guided PCI with IVUS-guided PCI in patients with diverse anatomical and clinical characteristics. He stated that the study enrolled adult patients undergoing DES implantation or DCB angioplasty (limited to in-stent restenotic lesions). Major exclusion criteria included STEMI, hemodynamic instability, severe renal dysfunction, inability to advance imaging catheters, and markedly calcified or tortuous lesions. He reported that at the 1-year follow-up, the primary endpoint—target vessel failure, defined as a composite of cardiac death, target-vessel myocardial infarction, or target-vessel revascularization—did not differ significantly between the two strategies. He emphasized that OCT-guided PCI met the predefined criteria for noninferiority compared with IVUS-guided PCI, demonstrating comparable clinical outcomes. Subgroup Analyses He highlighted that predefined subgroup analyses consistently demonstrated similar outcomes between OCT and IVUS across clinically relevant categories. Complex coronary lesions: Among 1,475 patients with left main disease, bifurcations, ostial lesions, CTOs, ISR, or diffuse long lesions, OCT performed comparably to IVUS. True bifurcation lesions: Even in challenging bifurcation disease—including high rates of LM involvement and two-stent techniques—OCT achieved clinical results similar to IVUS. In-stent restenosis (ISR): In ISR lesions, a slight directional trend in favor of OCT guidance was observed, but this should be interpreted with caution and may be attributable to OCT’s greater capability for visualizing neointimal structure Acute coronary syndrome (ACS): In patients with unstable angina or non-STEMI, both imaging modalities again yielded consistent results without evidence of interaction. In conclusion, he stated that the OCTIVUS trial demonstrated that OCT-guided PCI was noninferior to IVUS-guided PCI with respect to 1-year clinical outcomes. He emphasized that OCT showed comparable performance across a broad spectrum of lesion subsets, including complex lesions, in-stent restenosis, bifurcations, and acute coronary syndromes. He concluded that regardless of whether OCT or IVUS is used, appropriate application of intracoronary imaging tailored to lesion characteristics and clinical context leads to improved clinical outcomes. Workshop 3: Imaging & Physiology Thursday, November 27, 1:10 PM ~ 2:20 PM Main Arena Watch Session Video

December 24, 2025 454

COMPLEX PCI 2025

Left Main and Multi-Vessel Disease: Don't Be Trapped by Old Data

At the 10th COMPLEX PCI 2025 in Seoul, Seung-Jung Park, MD, PhD (Asan Medical Center, Korea), delivered a provocative keynote address titled "Guideline-Based Real-World Practice." He boldly challenged the global medical community to stop relying on outdated clinical guidelines and to embrace 'State-of-the-Art PCI'—a modern approach driven by physiology and intravascular imaging—as a superior alternative for Left Main and Multi-Vessel disease. The "Blind Spot" of Current Guidelines: A Legacy of Outdated Trials He began by critically analyzing the evidence base of current international guidelines. He pointed out that the "Class I" recommendations for CABG in patients with multivessel disease, diabetes, or reduced ejection fraction are largely derived from historical trials such as CASS, STICH, SYNTAX, and FREEDOM. "These landmark trials compared medical therapy or surgery against PCI techniques from a bygone era," he noted. "They utilized bare-metal stents or first-generation drug-eluting stents and, most critically, were performed without the guidance of physiology or intravascular imaging." He emphasized that comparing modern surgical outcomes against outdated PCI data creates a distorted view of clinical reality, potentially denying patients less invasive treatment options that are now viable. Era of 'State-of-the-Art PCI' The core of his argument centered on the concept of "State-of-the-Art PCI." He defined this not merely as the implantation of a stent, but as a comprehensive procedural standard that integrates: Physiological Assessment: Using Fractional Flow Reserve (FFR) to precisely identify ischemia-causing lesions and avoid unnecessary stenting. Intravascular Imaging: Utilizing IVUS (Intravascular Ultrasound) or OCT (Optical Coherence Tomography) to ensure optimal stent expansion and apposition. Modern Devices: The use of the latest generation Drug-Eluting Stents (DES). "When we apply these precision tools, the clinical outcomes of PCI improve dramatically," he stated. "We must ask ourselves: if we treat a diabetic multivessel disease patient with 'State-of-the-Art PCI' today, would the results still be inferior to CABG? The old data cannot answer this question." A Paradigm Shift for Left Main and Multivessel Disease Addressing Left Main (LM) coronary artery disease, he highlighted that it should no longer be considered a condition requiring unconditional surgery. "For lesions with low to intermediate anatomical complexity, PCI has already proven its competitiveness," he asserted. He urged the audience to adopt a "Heart Team" approach that respects real-world evidence, where modern PCI offers a safe and effective alternative for high-risk patients who are often poor candidates for surgery. He concluded his lecture by calling for new, large-scale randomized controlled trials (RCTs) that evaluate 'State-of-the-Art PCI' against CABG, ensuring that future guidelines are built on evidence that reflects the current technological landscape. "We must not be trapped by the dogmas of the past," he remarked, setting a progressive tone for the remainder of the conference. "It is time to rewrite the rules based on the precision medicine we practice today." Opening & Workshop 1: Left Main & Multi-Vessel Disease Thursday, November 27, 10:30 AM ~ 12:00 PM Main Arena Watch Session Video

December 19, 2025 483

COMPLEX PCI 2025

DEFINE-DM Trial to Reassess Revascularization in Diabetic Multivessel Disease

At the COMPLEX PCI 2025 meeting, Duk-Woo Park, MD, PhD (Asan Medical Center, Korea), presented the concept and design of the DEFINE-DM trial, a new randomized study designed to reassess revascularization strategies in patients with diabetes and multivessel coronary artery disease. He noted that existing recommendations favor CABG, based on evidence from prior RCTs—such as SYNTAX, BEST, FREEDOM, and BARI-2D—that were conducted before the introduction of current-generation DES, routine intravascular imaging, coronary physiology assessment, and modern antidiabetic agents. He emphasized that PCI practice has changed markedly in recent years, with broader use of IVUS/OCT, FFR-guided lesion selection, and improved stent platforms. In addition, contemporary diabetes therapy, including SGLT-2 inhibitors and GLP-1 receptor agonists, has demonstrated cardiovascular benefits not available during earlier trials. Given these advances, he stated that updated evidence is needed to determine whether PCI can offer comparable outcomes to CABG in appropriately selected diabetic patients. DEFINE-DM is designed to address these gaps. The trial will randomize 1,500 patients with type 2 diabetes and angiographically confirmed three-vessel disease who are suitable for either PCI or surgery. The primary endpoint was defined as the composite of all-cause death, myocardial infarction, or stroke at two years. Based on an estimated 11% two-year event rate in the CABG group for the primary endpoint, he explained that the sample size was determined to provide sufficient power to evaluate the non-inferiority of PCI compared with surgery. Patients assigned to PCI will undergo physiology-guided or imaging-guided intervention using contemporary everolimus-eluting stents. Lesion selection will be guided by FFR or iFR when appropriate, and post-procedure intravascular imaging with IVUS or OCT will be mandated to ensure optimal stent deployment. The combined use of drug-eluting stents and drug-coated balloons will be permitted at the operator’s discretion, and staged PCI will be allowed when clinically indicated. Patients assigned to CABG will undergo surgery within 30 days after randomization, following standard surgical practice with an emphasis on complete revascularization whenever feasible. Use of an internal mammary artery graft to the left anterior descending artery will be strongly recommended, with additional conduit strategies determined by the operating surgeon. All patients in both treatment arms will receive guideline-directed medical therapy, including structured diabetes care and strong recommendations for the use of SGLT-2 inhibitors or GLP-1 receptor agonists. He concluded that DEFINE-DM is expected to provide contemporary data reflecting current PCI techniques and modern medical therapy. “Previous trials do not represent today’s practice,” he said. “DEFINE-DM will help clarify the role of PCI as a potential alternative to CABG in diabetic multivessel disease.” Opening & Workshop 1: Left Main & Multi-Vessel Disease Thursday, November 27, 10:30 AM ~ 12:00 PM Main Arena Watch Session Video

December 19, 2025 409

COMPLEX PCI 2025

Imaging as the Compass: Defining IVUS Criteria for Optimal Left Main Bifurcation Stenting

At the COMPLEX PCI 2025 Workshop on Bifurcation PCI, Jung-Min Ahn, MD, PhD (Asan Medical Center, Korea), brought critical nuance to the long-standing debate over stenting strategies for complex left main (LM) bifurcation lesions. His lecture, titled “Imaging and IVUS-Guided Criteria for Optimal Left Main Bifurcation Stenting,” presented new, data-driven benchmarks for guiding two- and one-stent procedures in unprotected left main coronary artery disease (ULMCAD) using intravascular ultrasound (IVUS). He began by revisiting the established “5-6-7-8” minimal stent area (MSA) rule for LM PCI IVUS guidance introduced by Kang et al. in 2011, acknowledging its clinical value but also its limitations in an era where techniques such as DK crush and IVUS-guided optimization are now the norm. “We need lesion-specific MSA targets,” he said, pointing to recently published multicenter outcomes and ASAN MAIN Registry data which suggest that IVUS-guided MSAs in both provisional and two-stent strategies are predictive of major adverse cardiac events (MACE) at five years. Two-Stent Strategy: Defining Safety Margins Through IVUS Drawing from a 292-patient cohort that underwent IVUS-guided crush technique PCI, he presented statistically validated MSA cutoffs to guide optimal expansion: Distal LM: 11.8 mm² (p = 0.24) LAD ostium: 8.3 mm² (p = 0.002) LCX ostium: 5.7 mm² (p = 0.005) Crucially, dual underexpansion—defined as not achieving the MSA thresholds in both LAD and LCX—was associated with significantly higher MACE rates, reinforcing the need for intravascular optimization regardless of stent count. “It’s not about choosing between one or two stents,” he emphasized, “but ensuring you deliver a physiologically meaningful result in both branches.” One-Stent Crossover Strategy: IVUS Is Not Optional In a parallel analysis of 829 patients treated with LM-to-LAD crossover using a single stent, he outlined a different MSA threshold hierarchy: Proximal LM: 11.4 mm² (p < 0.001) Distal LM: 8.4 mm² (p = 0.005) Proximal LAD: 8.1 mm² (p = 0.013) These numbers were derived from the EuroIntervention 2025 study, and showed that even with a single-stent strategy, underexpansion in two segments independently predicted poorer 5-year outcomes. This finding highlights the importance of systematic IVUS pullbacks both before and after stenting, particularly in LM bifurcation lesions classified as Medina 1,1,1 or 0,1,1. Pre-Stenting LCX Assessment: The True Decision Driver Notably, he introduced an unpublished algorithm based on pre-stenting IVUS of the LCX ostium, defining high-risk lesions as those with a minimal lumen area (MLA) < 3.8 mm² or plaque burden (PB) ≥ 57%. Patients with these characteristics showed significantly higher LCX compromise rates post-provisional stenting—even when side branch dissection or lesion length were not predictive factors. “LCX ostial plaque burden, not angiographic appearance, should guide whether a second stent is needed,” he stressed. In patients with both low-risk IVUS profiles and good crossover expansion, one-stent strategies performed equivalently to two-stent techniques. Conversely, in the high-risk group, two-stent strategies led to superior outcomes only when underexpansion was avoided—again highlighting optimization over technique. Summarizing his findings, he proposed a practical imaging-guided treatment algorithm for LM bifurcation PCI: Perform pre-stenting IVUS of LCX. Apply the 3.8 mm² / 57% MLA-PB thresholds. Use IVUS-defined MSA targets to optimize whichever technique is selected. Consider early two-stenting in high-risk LCX ostium cases only if adequate expansion can be assured. He concluded, “In bifurcation PCI, imaging is not just supportive—it’s decisive.” The lecture underscored that with tailored intravascular imaging and lesion-specific expansion criteria, the choice between one or two stents becomes less philosophical and more anatomical. This data-driven, physiology-informed approach offers clinicians a roadmap to reducing ambiguity in bifurcation PCI, ultimately improving patient outcomes through precision-based interventional cardiology. Workshop 2: Bifurcation Thursday, November 27, 12:00 PM ~ 1:10 PM Main Arena Watch Session Video

December 19, 2025 460

SEOUL VALVES 2025

Out-of-the-Box Solutions for Mitral Valve Repair and Replacement

At the 14th SEOUL VALVES 2025 meeting, during the Keynote Session: Cutting-Edge Innovations in Valve Therapies II, Eberhard Grube, MD (University Hospital Bonn, Germany), presented an overview of emerging innovations in the treatment of mitral valve disease, under the theme “Out-of-the-Box Solutions for Mitral Valve Repair and Replacement.” He emphasized the need for new strategies beyond conventional surgery and transcatheter edge-to-edge repair (TEER), and highlighted novel technologies currently under investigation. He began by revisiting the long-standing challenges of mitral regurgitation (MR) management, stressing the importance of early intervention to reduce regurgitation, promote reverse remodeling, and keep future treatment options open. Recent evidence, including 5-year outcomes from the COAPT trial, showed durable benefits of TEER in secondary MR. However, he underscored its limitations: achieving MR reduction alone may not be sufficient, and outcomes remain suboptimal in certain patient subsets. This has prompted exploration of novel concepts offering solutions for anatomies unsuitable for conventional TEER or surgery. He reviewed several investigational devices: the Half Moon system, designed to provide coaptation augmentation with a contoured baffle; the SUTRA, 3 Leaflet Hemi-Valve for posterior leaflet restoration; the Polares MRace device, offering active posterior leaflet replacement with encouraging early clinical results; and the CARLEN device (Transcatheter Cardiac Leaflet Enhancer), which enables wide and deep coaptation in functional MR across varied anatomies. First-in-human experiences demonstrated procedural feasibility and early reductions in MR, although long-term outcomes are still under evaluation. In closing, he emphasized that mitral valve disease remains “messy and complicated,” and that innovation requires the courage to move beyond established approaches. He concluded that while TEER remains the gold standard today, out-of-the-box solutions such as leaflet augmentation or hemi-valve replacement could expand the range of therapeutic options for challenging MR anatomies in the near future. Keynote Session: Cutting-Edge Innovations in Valve Therapies II Friday, August 8, 1:00 PM-2:00 PM Main Arena, B2 Watch Session Video

September 05, 2025 17196

SEOUL VALVES 2025

Optimizing Medical Therapy After TAVR: Focus on SGLT2 Inhibitors

At the 14th SEOUL VALVES 2025 meeting, during the Keynote Session: Cutting-Edge Innovations in Valve Therapies I, Duk-Woo Park, MD, PhD (Asan Medical Center, Korea), delivered a keynote lecture titled “What Is the Best Medical Therapy for TAVR Patients?” He reviewed evidence for sodium–glucose cotransporter 2 inhibitors (SGLT2i) after transcatheter aortic valve replacement (TAVR) and introduced the design of an ongoing randomized trial in post-TAVR patients. TAVR effectively relieves valvular obstruction but often leaves behind myocardial damage—fibrosis, hypertrophy—a high residual risk of heart failure (HF), especially in elderly patients underrepresented in earlier SGLT2i trials. This creates a strong rationale for optimal medical therapy (OMT) strategies that target remodeling and HF prevention in the post-TAVR period. In the DAPA-TAVI trial published in NEJM in 2025, patients were randomized 1:1 at discharge or within 14 days post-TAVR to dapagliflozin or usual care, stratified by diabetes, left ventricular ejection fraction (LVEF) ≤40%, and eGFR 25–75 mL/min/1.73㎡. Among 1,257 participants, the primary—composite of all-cause death or worsening HF—occurred in 15.0% with dapagliflozin vs. 20.1% with standard care (p=0.018; hazard ratio [HR] 0.72; 95% confidence interval [CI], 0.55–0.95), driven mainly by reductions HF hospitalizations or urgent HF visits. Effects were consistent across prespecified subgroups. Safety was acceptable overall, with higher rates of genitourinary infections and hypotension noted. Importantly, nearly one-third of post-TAVR patients experience HF readmission within 12 months, and many have preserved LVEF, a population not tested in prior TAVR-specific SGLT2i trials despite supportive data from EMPEROR-Preserved and DELIVER in general HF with preserved ejection fraction (HFpEF) populations. To address this gap, the ENAVO-TAVR trial (ENAVOgliflozin Outcome Trial in Patients with Severe Aortic Stenosis after Transcatheter Aortic Valve Replacement) has been initiated. The study will randomize 1,040 post-TAVR patients with LVEF ≥40%, structural heart disease (Left ventricular hypertrophy and/or left atrial enlargement), and elevated NT-proBNP to enavogliflozin 0.3 mg once daily (a dose equivalent to dapagliflozin/empagliflozin 10 mg) versus matching placebo within 2 weeks of successful TAVR. The primary endpoint is major adverse cardiovascular events (all-cause death, nonfatal MI, or stroke) or HF hospitalization at 1 year. Approximately 40 Korean centers are participating, and enrollment has begun. In conclusion, SGLT2 inhibitors show strong promise in improving post-TAVR outcomes by mitigating HF progression and promoting cardiac recovery. While DAPA-TAVI supports their use in HF with reduced LVEF and in patients with chronic kidney disease or diabetes, the ENAVO-TAVR trial will determine efficacy in the broader HFpEF TAVR population. Accumulating evidence supports integrating SGLT2i into OMT for TAVR patients to improve long-term clinical and structural outcomes. Keynote Session: Cutting-Edge Innovations in Valve Therapies I Thursday, August 7, 1:00 PM-2:00 PM Main Arena, B2 Watch Session Video

September 05, 2025 805

SEOUL VALVES 2025

16 Years' Journey in TAVR at Asan Medical Center

At the 14th SEOUL VALVES 2025 meeting, Seung-Jung Park, MD, PhD (Asan Medical Center, Korea), presented the 16-year journey of transcatheter aortic valve replacement (TAVR) at AMC, reflecting on its evolution from the pioneering era to its current status as a standard therapy in patients with severe aortic stenosis. Since performing the first case in March 2010 under the proctorship of Dr. Alain Cribier, AMC has now performed a total of 2,289 TAVR procedures, with more than 300 procedures performed annually. Over this period, AMC established itself as a leading center in Asia, reporting outstanding outcomes with a procedural success rate of 99.7%. Evolution of TAVR Guidelines and Clinical Practice The 2020 ACC/AHA guidelines recommended TAVR as Class I for patients aged 65–80 years, while the 2021 ESC/EACTS guidelines adopted a higher threshold, recommending TAVR as Class I in patients above 75 years. However, real-world practice has shifted rapidly. Registry data from the United States demonstrated that by 2021, 78% of patients under 65 years already received TAVR, highlighting a strong trend toward younger and lower-risk patients. AMC's TAVR Success: The Role of Minimalist Approaches and CT Algorithms AMC’s success has been attributed to three key strategies: Heart Team collaboration, minimalist approach, and CT-based device selection algorithm. More than 99% of AMC cases were performed using local or conscious sedation without general anesthesia or transesophageal echocardiography (TEE) guidance. The average procedure time was only 30 minutes, with most patients discharged within three days. Pre-procedural CT analysis was emphasized as the cornerstone for device selection, incorporating vascular access, aortic annulus size, coronary height, and calcium burden. This meticulous planning minimized complications such as paravalvular leak (PVL) and the need for permanent pacemaker implantation (PPI). AMC favored balloon-expandable valves (88%), reporting lower PVL rates (2.5%) and acceptable permanent pacemaker rates (8.7%). Clinical outcomes were excellent: Thirty-day mortality was only 1.4%, with disabling stroke at 0.5%. At one year, all-cause mortality was 7.2%, reflecting durable benefit comparable or superior to outcomes from major international trials. Bicuspid Aortic Valve: Challenges and Outcomes A particular focus was given to bicuspid aortic valve (BAV) stenosis, which accounted for 217 cases (9.4%) in the AMC registry. Meta-analysis data including 12,462 patients indicated that bicuspid TAVR carried a slightly higher risk of moderate PVL and aortic root injury compared to tricuspid cases. In AMC’s experience, patients with bicuspid valves tended to be younger and had significantly higher calcium burdens (mean calcium volume 670 mm³ vs. 380 mm³ in tricuspid). Type I bicuspid anatomy was most frequent. Despite these challenges, outcomes remained favorable: propensity-matched analysis revealed no significant differences in hard endpoints such as cardiac mortality and stroke between bicuspid and tricuspid TAVR. AMC favored the use of Sapien 3 valves even in bicuspid cases, often performing pre- and post-dilatation in patients with heavy calcification. These findings reinforced that with meticulous CT planning and careful device selection, bicuspid TAVR can achieve outcomes comparable to tricuspid cases. He concluded that TAVR had firmly established itself as the primary treatment for symptomatic severe aortic stenosis at AMC, with surgery reserved for patients unsuitable for TAVR. He emphasized that comprehensive CT analysis and tailored device selection remained the most critical factors for ensuring excellent outcomes, especially in complex anatomies such as bicuspid valves or small annuli. Opening, Live Case & Lecture 1: TAVR Thursday, August 7, 10:00 AM-12:00 PM Main Arena, B2 Watch Session Video

August 29, 2025 884

SEOUL VALVES 2025

Bicuspid TAVR: Technical Challenges and Asan Data Insights

At the 14th SEOUL VALVES 2025 meeting, Jung-Min Ahn, MD, PhD (Asan Medical Center, Korea), delivered a comprehensive lecture titled “Bicuspid TAVR: All the Technical Issues and Data from Asan Medical Center.” His lecture summarized the unique anatomical and clinical challenges of bicuspid aortic valve (BAV) patients undergoing TAVR, findings from the Asan TAVR Registry and an ongoing meta-analytic review. Bicuspid aortic valve disease is typically found in younger, male-predominant populations with fewer comorbidities compared with tricuspid valve disease. Echocardiographic and CT findings show that BAV is associated with more severe aortic stenosis, larger and asymmetric annuli, and markedly higher calcification volumes. In the Asan registry, mean calcification volume in tricuspid valves is about 300 mm³, whereas in bicuspid valves it nearly doubles to around 600 mm³ (Figure 1). In surgical series, up to 65% of patients under 60 years presented with BAV, highlighting the need to consider long-term valve durability and lifetime management strategies in this younger population. Figure 1. The heavier and asymmetric calcification burden in BAV makes device sizing particularly challenging. In cases with severe calcification (>1000 mm³), nominal sizing or undersizing is used to avoid annular rupture. With lower calcification burden, oversizing may be applied, even in type 0 BAV anatomy (Figure 2). Figure 2. Procedurally, larger transcatheter valves and more frequent pre- and post-dilation are often required, increasing the potential for annular rupture, coronary obstruction, or conduction disturbances. Nevertheless, Asan data suggest that overall complication rates remain acceptable and are not significantly higher than in tricuspid cases (Figure 3). Figure 3 . Two-year echocardiographic follow-up in the Asan registry showed that BAV patients achieved comparable outcomes to tricuspid patients; 1) Effective orifice area remained favorable, 2) Prosthesis–patient mismatch (PPM) was lower in BAV patients, owing to larger annular size, and 3) Mortality and stroke rates were similar between the groups at two years (Figure 4 and 5). Still, he emphasized that long-term outcomes beyond five years remain uncertain. In the NOTION-2 trial, bicuspid patients younger than 75 years undergoing TAVR demonstrated numerically higher death and stroke rates, raising concern about durability and safety in this subgroup. Figure 4. Figure 5. In the meta-analytic review discussed during the lecture, which pooled results from 35 studies including over 13,000 BAV and nearly 200,000 TAV patients, BAV TAVR was associated with higher risks of adverse outcomes compared with tricuspid TAVR. Specifically, bicuspid patients experienced more frequent paravalvular leakage, aortic root injury, and higher rates of early mortality and stroke (Figure 6). By contrast, the incidence of permanent pacemaker implantation and major bleeding did not differ significantly between the two groups. Figure 6. When comparing TAVR and SAVR in BAV patients, published data suggest broadly similar short-term mortality and stroke rates. However, TAVR is associated with a greater risk of paravalvular leak, whereas SAVR carries a higher risk of bleeding complications (Figure 7). Figure 7. He concluded that TAVR is feasible and safe in carefully selected bicuspid patients with current-generation devices, but several key principles must guide practice: Meticulous patient selection and pre-procedural CT planning are essential. Sizing algorithms incorporating calcification volume help mitigate complications. Strategies to reduce pacemaker implantation are particularly important in younger patients. Not all bicuspid anatomies are suitable for TAVR—there is a clear need for a BAV-specific scoring system to guide decision-making between TAVR and SAVR. His lecture underscored that bicuspid anatomy remains one of the most challenging frontiers in TAVR. With ongoing data collection and refinement of devices and implantation techniques, patient-tailored strategies will be critical to optimizing outcomes for this complex group. Live Case & Lecture 2: Complex TAVR (Bicuspid) Thursday, August 7, 2:00 PM-3:30 PM Main Arena, B2 Watch Session Video

August 29, 2025 876

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