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SEOUL VALVES 2026

From Bench Validation to Best Clinical Practice : Novel Electrosurgery in High-Risk TAVR

At SEOUL VALVES 2026, Cheung Chi Simon Lam, MD (Queen Mary Hospital, Hong Kong, China) presented a session on the evolution of electrosurgery in high-risk transcatheter aortic valve replacement (TAVR), tracing its trajectory from bench-top validation to standardized clinical practice. The session first reviewed BASILICA (Bioprosthetic or native Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery obstruction), the original electrosurgical leaflet-splitting technique, illustrating its workflow with the electrified 'flying V' guidewire traversal used to lacerate the target leaflet before valve deployment, along with solo-operator access configurations and a modified pigtail catheter setup for precise leaflet crossing. The central focus was UNICORN (Undermining Iatrogenic Coronary Obstruction with Radiofrequency Needle), a technique developed at Queen Mary Hospital specifically for redo-TAVR (TAV-in-TAV), where a previously implanted valve leaflet must be modified. Unlike BASILICA, UNICORN creates a fenestration in the existing leaflet using a radiofrequency needle, permitting intra-leaflet deployment of the second valve. The technique has been applied to both balloon-expandable and self-expanding valves, as well as combined bi-leaflet UNICORN-BASILICA cases, with 100% Sentinel cerebral embolic protection use across the reported experience. Bench-top validation confirmed UNICORN's feasibility across the SAPIEN 3, Evolut, and ACURATE neo2 platforms, though the Navitor platform could not be fully opened with nominal balloon volume. A related comparison found UNICORN produced functional splay areas two to ten times larger than BASILICA when intra-leaflet deployment was feasible, though results varied with valve design and implantation depth. Figure 1. UNICORN Leaflet Modification Concept Across Valve Types Real-world outcomes came from the Asia-Pacific Electrosurgery Working Group registry (100 patients, 7 centers). BASILICA was performed in 67% of cases and UNICORN in 30%, with procedural success of 85.1% and 96.7% respectively, and coronary obstruction in only 2.99% of BASILICA patients. Annual case volume had risen more than 10-fold over five years. The table below, drawn from the presentation and the accompanying literature, summarizes the key distinctions between BASILICA and UNICORN. Feature BASILICA UNICORN Full name Bioprosthetic or native Aortic Scallop Intentional Laceration to prevent Iatrogenic Coronary Artery Obstruction Undermining Iatrogenic Coronary Obstruction with Radiofrequency Needle Mechanism Mechanical traversal and electrified guidewire laceration of the leaflet before valve deployment Radiofrequency needle/wire traversal and fenestration of the leaflet, allowing intra-leaflet deployment of the second valve Best suited for Native or failed surgical valve leaflets (TAVR, TAV-in-SAV) Failed transcatheter valve leaflets in redo-TAVR (TAV-in-TAV) Reported procedural success 85.1% (Asia-Pacific registry, n=67) 96.7% (Asia-Pacific registry, n=30) Functional splay area Smaller, vertical V-shaped splay Larger (2-10x BASILICA) when intra-leaflet deployment is feasible A second application discussed was prevention of suicidal LV in patients with severe AS and concomitant HOCM. Early experience with SESAME (Septal Scoring Along the Midline Endocardium), a transcatheter electrosurgical septal reduction technique, was presented. In four cases, SESAME reduced left ventricular outflow tract (LVOT) gradients in all patients, with one requiring pacemaker implantation for high-grade atrioventricular block; at one- to three-month follow-up, all showed improved gradients and functional status. Emerging refinements were also introduced, including a CT-guided fluoroscopic workflow for identifying the optimal leaflet split line in redo-TAVR, the CLEAR technique to reduce chordal entrapment during BASILICA, and the investigational Shortcut device (Pi-Cardia), a mechanical alternative for standardized leaflet splitting. Live Case & Lecture 2: Complex TAVR (Valve in Valve) Thursday, August 6, 2:00 PM ~ 3:30 PM Main Arena, Level 2 Watch Session Video

August 27, 2026 221

TCTAP 2026

Carotid Artery Near Occlusion: Current Evidence and Practice

Carotid artery near occlusion (CANO) had long remained a difficult gray zone in carotid intervention. At TCTAP 2026, Hsien-Li Kao, MD (National Taiwan University Hospital, Taiwan), reviewed the current evidence and his practical approach to this challenging lesion. His central message was that CANO was not simply severe carotid stenosis or complete occlusion, but a distinct delayed-flow state caused by critical stenosis that required careful diagnosis and individualized revascularization planning. Defining CANO Beyond Percent Stenosis He defined CANO as severe carotid stenosis with reduced distal internal carotid artery (ICA) flow. He noted that the same entity had been described historically by terms such as the “string sign,” “pseudo‑occlusion,” “pre‑occlusive stenosis,” and “hairline residual lumen.” Diagnosis was considered when at least two of four angiographic criteria were present: delayed filling of the distal ICA, intracranial collateral flow, an ipsilateral distal ICA smaller than the contralateral distal ICA, and an ipsilateral distal ICA equal to or smaller than the ipsilateral external carotid artery (ECA). Why Distal Lumen Collapse Mattered A key point of the presentation was the distinction between CANO with and without distal ICA collapse. Full collapse was defined as a distal ICA diameter of 2.0 mm or less and/or an ipsilateral‑to‑contralateral distal ICA diameter ratio of 0.42 or less (Neuroradiology 2022;64:59‑67). He emphasized that this distinction was clinically relevant because near‑occlusion with collapse carried a higher risk of recurrent ipsilateral stroke and should not have been grouped uncritically with non‑collapsed near‑occlusion. He proposed a working classification that placed near occlusion as an intermediate state between conventional stenosis and total occlusion, with collapse and non‑collapse as further subgroups (Figure 1). Figure 1. Working classification of carotid stenosis, with near occlusion further divided into “with collapse” and “without collapse.” Adapted from his TCTAP 2026 presentation; collapse criteria from Neuroradiology 2022;64:59‑67. Representative digital subtraction angiograms (Figure 2) further illustrated the spectrum: CANO with collapse showed a thread‑like distal ICA, CANO without collapse retained a near‑normal distal caliber despite a critical proximal lesion, and conventional carotid stenosis showed a focal lesion without distal hemodynamic compromise. Figure 2. Representative carotid angiograms. (A) CANO with distal lumen collapse; (B) CANO without collapse; (C) conventional non-CANO carotid stenosis. Asterisks mark the ICA bulb; arrows mark the lesion. Adapted from his TCTAP 2026 presentation. Evidence Remained Limited The evidence base remained thin because CANO had been excluded from, or poorly represented in, the landmark randomized carotid trials that shaped routine practice (NASCET, ECST, CREST, and ICSS). Although small near‑occlusion subgroups appeared in NASCET and ECST analyses (Am J Neuroradiol 2005;26:2086‑94), he stressed that these were old CEA‑era data with limited case numbers rather than dedicated CANO trials. More recent evidence suggested that best medical therapy alone might not have been sufficient for some patients (Br J Surg 2019;106:665‑71), particularly those with distal collapse and recurrent symptoms (J Neurol 2020;267:522‑30). The 2023 ESVS guideline recommendation was also cautious: revascularization could be considered for patients with carotid near occlusion and distal vessel collapse who had recurrent carotid‑territory symptoms despite best medical therapy, but only after multidisciplinary team review (Eur J Vasc Endovasc Surg 2023;65:7‑111). Periprocedural Safety of CAS To address whether carotid artery stenting (CAS) for CANO was inherently risky, he reviewed his group’s experience published in Scientific Reports in 2021 (Sci Rep 2021;11:21876). The cohort compared 92 CANO patients with 106 age‑ and sex‑matched patients who had conventional 70% to 99% carotid stenosis. Full distal collapse was present in 45 of the 92 CANO patients. Despite longer target‑lesion length and a higher symptomatic‑disease rate in the collapse subgroup, the technical success rate was 100%, and the 30‑day safety outcomes were comparable between CANO and conventional stenosis (Table 1). Table 1. Thirty‑Day Outcomes After CAS in CANO Versus Conventional Carotid Stenosis Outcome CANO (N = 92) Conventional (N = 106) P value Hyperperfusion syndrome 2 (2.2%) 1 (0.9%) 0.598 Ischemic stroke 1 (1.1%) 2 (1.9%) 1.000 Major ipsilateral stroke 1 (1.1%) 1 (0.9%) 1.000 Mortality 0 (0.0%) 1 (0.9%) 1.000 All stroke and mortality 1 (1.1%) 2 (1.9%) 1.000 CAS = carotid artery stenting; CANO = carotid artery near occlusion. Data were adapted from the TCTAP 2026 presentation and Sci Rep 2021;11:21876. Technical Approach The case‑based portion of the talk illustrated why the procedure remained technically demanding. He showed careful lesion crossing with an 8‑Fr JR4 guiding catheter, a Fielder FC guidewire supported by a Finecross microcatheter, and distal embolic protection with a Spider device. In the 2021 cohort, embolic protection was used in 98% of CANO cases. Predilatation before stent deployment was more frequent in CANO than in conventional stenosis (30% vs. 11%; P = 0.001), and predilatation before embolic‑protection‑device placement was used more often in the collapse subgroup, reflecting the challenge of safely passing devices through a thread‑like residual lumen. Long‑Term Perspective He also cited long‑term data from his group (Eur J Radiol 2025;191:112297) and a smaller independent cohort (Am J Neuroradiol 2022;43:1311‑17). These reports suggested that long‑term outcomes after CAS were comparable with those after stenting for conventional severe carotid stenosis. However, the evidence remained observational, and the presentation repeatedly underscored the need for prospective dedicated data. Conclusions He concluded that CANO was neither ordinary carotid stenosis nor complete occlusion, but a delayed‑flow state caused by critical stenosis. CANO was associated with a high recurrent-stroke risk, especially when distal lumen collapse was present. CEA was described as inherently difficult in this anatomy, and CAS appeared feasible and safe in experienced centers, with a potential role in selected patients with CANO and distal collapse. The key remaining question was not whether CANO deserved attention, but which patients would benefit most from revascularization — a question that still required prospective study. Hot Topics Practical Approaches to Stroke, Carotid, and Peripheral Interventions Friday, May 1, 4:20 PM ~ 5:40 PM Presentation Theater 2, Level 1

June 11, 2026 7749

TCTAP 2026

DanGer Shock and ECLS-SHOCK: New Evidence for MCS in Cardiogenic Shock

Speaking on May 1 during the Hot Topics session “The Next Era of ACS Management: Timing, Techniques, and Targeted Therapy” at TCTAP 2026, Kwan Seung Lee, MBBCh, MD, MB (Mayo Clinic Arizona, USA), reviewed the latest evidence for mechanical circulatory support (MCS) in cardiogenic shock, highlighting a significant shift in treatment strategies following two landmark trials. The discussion focused on the contrasting results of the DanGer Shockand ECLS-SHOCK trials. The DanGer Shock trial provided a breakthrough, showing that the use of a micro-axial flow pump (Impella CP) in STEMI-related shock significantly reduced 180-day mortality (46% vs. 59% in standard care). He noted an NNT of 7.7, which improved to 6.3 in long-term 10-year data. However, the survival benefit was coupled with higher risks of major bleeding and vascular complications. In contrast, the ECLS-SHOCK trial demonstrated no mortality benefit for routine VA-ECMO in ACS shock. Consequently, he emphasized that routine ECMO is no longer recommended, though it remains a rescue option. The presentation also addressed patient selection and procedural factors. Data showed that the benefits of Impella diminished with age, with mortality reaching 73% in the oldest patients. Furthermore, an analysis from DanGer Shock suggested that immediate multi-vessel PCI was associated with 60% lower odds of mortality compared to a culprit-only approach. He concluded that while Impella is now a proven tool for reducing mortality in select STEMI shock patients, careful consideration of age and procedural risks remains essential for optimizing outcomes. Hot Topics The Next Era of ACS Management: Timing, Techniques, and Targeted Therapy Friday, May 1, 1:30 PM ~ 2:55 PM Presentation Theater 2, Level 1

June 11, 2026 392

TCTAP 2026

OMT or PCI for Single CTO Without Concomitant Disease?

Speaking on April 30 during the TCTAP Workshops session “When to Consider CTO PCI: From Decision to Execution” at TCTAP 2026, Gerald S. Werner, MD, PhD (University Heart Centre Frankfurt, Germany), delivered a lecture titled “OMT vs. PCI for Single-Vessel CTO: A Combined Analysis From DECISION-CTO and EUROCTO Trials.” The presentation focused on whether CTO PCI offers clinical benefit beyond optimal medical therapy in patients with isolated symptomatic CTO, drawing on pooled evidence from two landmark randomized trials. Chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has become one of the most technically advanced fields in contemporary interventional cardiology. Dedicated crossing algorithms, specialized guidewires, and increasing operator experience have markedly improved procedural success rates. However, despite these technical achievements, the fundamental question remains unchanged: Does CTO PCI improve clinical outcomes beyond symptom relief? Two landmark randomized trials have attempted to answer this question. The EUROCTO trial demonstrated significant improvements in angina and quality of life following CTO PCI, whereas the DECISION-CTO trial did not demonstrate a reduction in major clinical events with a CTO PCI strategy compared with optimal medical therapy. Importantly, these trials evaluated different clinical questions and endpoints, highlighting the distinction between symptomatic and prognostic benefits of CTO revascularization. To address this issue, he presented a pooled patient-level analysis combining the EUROCTO and DECISION-CTO randomized trials. Importantly, the pooled analysis included only patients in whom the CTO lesion was considered the primary symptomatic target, excluding those who had undergone non-CTO PCI within 6 months before or 3 months after randomization. This design aimed to isolate the specific clinical impact of CTO revascularization. The pooled cohort included 518 patients, with 224 assigned to OMT and 294 assigned to PCI. Baseline characteristics were well balanced between groups, including age, diabetes prevalence, prior PCI history, left ventricular function, and CTO location. Procedural success was achieved in more than 90% of PCI cases, reflecting contemporary CTO practice in experienced centers. The most important finding was the consistent improvement in patient-reported outcomes after CTO PCI. Compared with OMT, PCI resulted in significantly greater improvements in multiple domains of the Seattle Angina Questionnaire, including physical limitation, angina frequency, quality of life, and overall summary score. Furthermore, a substantially larger proportion of PCI-treated patients achieved clinically meaningful improvements in quality-of-life measures. Patients with worse baseline symptoms derived the greatest benefit, suggesting that symptom burden remains the strongest determinant of treatment effect. Notably, these benefits were achieved without evidence of increased long-term cardiovascular risk. During follow-up, rates of cardiac death and non-fatal myocardial infarction were similar between PCI and OMT groups. Although a small number of periprocedural myocardial infarctions occurred in the PCI arm, overall major adverse cardiovascular events were not increased. In contrast, ischemia-driven repeat revascularization was significantly lower after PCI, indicating greater durability of symptom control. A particularly interesting observation emerged when outcomes were stratified according to procedural success. Patients with successful CTO PCI experienced the lowest event rates and the greatest symptomatic improvement, whereas failed procedures were associated with substantially worse outcomes. This finding highlights an often-overlooked principle in CTO intervention: the clinical value of CTO PCI is highly dependent on procedural success. CTO PCI is not merely a decision to intervene but a decision to intervene successfully. Ultimately, the combined EUROCTO and DECISION-CTO analysis reinforces a practical message for contemporary CTO practice. CTO PCI should not be routinely performed with the expectation of improving survival. Instead, it should be considered for carefully selected patients with persistent symptoms despite medical therapy, particularly when a high likelihood of procedural success can be achieved in experienced CTO centers. In this setting, CTO PCI remains one of the most effective strategies for improving angina and restoring quality of life. TCTAP Workshops When to Consider CTO PCI: From Decision to Execution Thursday, April 30, 8:30 AM ~ 9:50 AM Presentation Theater 1, Level 1 Watch Session Video

June 11, 2026 394

TCTAP 2026

CTO PCI – When Is It Truly Indicated?: A Guideline-Based Perspective

Speaking on April 30 during the TCTAP Workshops session “When to Consider CTO PCI: From Decision to Execution” at TCTAP 2026, Jung-Min Ahn, MD, PhD (Asan Medical Center, Korea), delivered a lecture titled “CTO PCI – When Is It Truly Indicated?: A Guideline-Based Perspective.” The presentation reviewed the evolving evidence and guideline recommendations for CTO PCI, focusing on when the procedure should be considered in contemporary clinical practice. Over the past two decades, chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has advanced dramatically. Contemporary crossing algorithms, advanced guidewires, and dedicated devices have increased procedural success rates to more than 95% in experienced centers. Despite these technical achievements, the clinical indication for CTO PCI remains controversial because randomized clinical trials have failed to demonstrate consistent survival benefits. Earlier enthusiasm for CTO PCI was largely driven by observational registry studies showing that successful CTO recanalization was associated with lower mortality and improved long-term outcomes compared with failed procedures. However, these studies were limited by selection bias and confounding factors. Subsequently, randomized trials such as DECISION-CTO, EUROCTO, EXPLORE, and REVASC attempted to clarify the true clinical role of CTO PCI. The DECISION-CTO trial compared CTO PCI plus optimal medical therapy with medical therapy alone. Although the study showed no significant reduction in major adverse cardiovascular events, several quality-of-life domains, including treatment satisfaction, improved after successful PCI. Similarly, the EUROCTO trial demonstrated significant improvement in angina relief and health status, but no clear reduction in death or myocardial infarction. Guideline recommendations therefore remain conservative. The 2021 ACC/AHA/SCAI guideline classified CTO PCI as a class IIb recommendation, indicating that the benefit of CTO PCI remained uncertain after treatment of non-CTO lesions. This cautious position reflected the discrepancy between impressive procedural success rates and the limited evidence for hard clinical endpoints. More recently, emerging evidence has suggested a more favorable role for CTO PCI in carefully selected patients. Meta-analyses combining the EURO-CTO and DECISION-CTO trials suggested improved symptom relief and clinically meaningful improvement in Seattle Angina Questionnaire scores. Furthermore, the ORBITA-CTO trial provided additional evidence supporting symptomatic benefit in patients with single symptomatic CTO lesions without significant non-CTO disease. Ongoing randomized trials such as ISCHEMIA-CTO and NOBLE-CTO were expected to provide more definitive evidence regarding the long-term prognostic impact of CTO PCI. Until those results become available, the principal role of CTO PCI remains symptom improvement and quality-of-life enhancement rather than survival benefit. At the end of the session, he stated that he planned to present the 10-year follow-up results of the DECISION-CTO trial at this year’s TCT meeting, thereby bringing the lecture to a meaningful conclusion with the long-term perspective of one of the landmark randomized CTO studies. TCTAP Workshops When to Consider CTO PCI: From Decision to Execution Thursday, April 30, 8:30 AM ~ 9:50 AM Presentation Theater 1, Level 1 Watch Session Video

June 11, 2026 382

TCTAP 2026

Optimal MSA in IVUS-Guided Left Main PCI: Revisiting “the 5-6-7-8” Rule

At TCTAP 2026, Ju Hyeon Kim, MD, PhD (Asan Medical Center, Korea), presented a comprehensive update on optimal minimal stent area (MSA) targets in intravascular ultrasound (IVUS)-guided left main (LM) percutaneous coronary intervention (PCI). The lecture revisited the long-standing “5-6-7-8” rule, and introduced a newly proposed “6-8-11” framework calibrated to one-stent versus two-stent strategies. LM PCI remains technically demanding, requiring optimal stent expansion and apposition, appropriate bifurcation technique, and adequate lesion coverage for acceptable long-term outcome. Multiple registries and randomized data — including the MAIN-COMPARE registry and the RENOVATE-COMPLEX-PCI trial — have consistently shown that intracoronary imaging guidance improves outcomes in LM PCI. In RENOVATE-COMPLEX-PCI, however, only about 60% of the imaging-guided PCI group achieved optimization as defined by the classic “5-6-7-8” criteria, highlighting that imaging use alone is not enough — the operator must also achieve meaningful procedural optimization. The “5-6-7-8” rule originated from Kang et al. (Circ Cardiovasc Interv. 2011), who identified segmental MSA cutoffs predicting 9-month in-stent restenosis across the four key LM segments: 5.0 mm² at the ostial LCX, 6.3 mm² at the distal LM polygon of confluence, 7.2 mm² at the ostial LAD, and 8.2 mm² at the proximal LM — rounded to 5, 6, 7, and 8. An important caveat to applying the “5-6-7-8” rule globally is that coronary artery dimensions differ across populations. Imaging and CT angiography comparisons suggest that Asian coronary arteries are generally smaller than those of Caucasian patients in unmatched populations. However, when comparing Korean and Western patients with similar reference dimensions, the IVUS-derived minimal lumen area thresholds to predict functionally significant LM stenosis were nearly identical, indicating that ischemic thresholds align once vessel size is accounted for. Across contemporary cohorts — including the original Kang series, the EXCEL IVUS substudy, a Spanish registry, and the NOBLE IVUS substudy — mean post-stenting MSAs at the proximal LM cluster around 10–12 mm², and at the distal LM around 8–10 mm², well above the original “8” and “6” targets in many series. In the recently published OPTIMAL trial (N Engl J Med. 2026), routine final IVUS in LM PCI did not translate into significantly lower clinical events, raising the question of how stringently the “5-6-7-8” criteria were met and whether they remain the right targets in modern practice. Kim et al. (Circ Cardiovasc Interv. 2024) analyzed 292 patients with unprotected LM bifurcation disease who underwent two-stent PCI with the crush technique, showing mean segmental MSAs were 10.9 ± 2.2 mm² at the distal LM, 8.2 ± 1.7 mm² at the LAD ostium, and 5.9 ± 1.4 mm² at the LCX ostium. Importantly, MSA within the distal LM was not predictive of 5-year MACE — likely because it was already sufficiently large. Instead, the strongest predictor of adverse events was concurrent underexpansion at both daughter ostia, defined as LAD MSA < 8.3 mm² combined with LCX MSA < 5.7 mm². In a follow-up analysis (EuroIntervention 2025), Kim et al. examined 829 patients with unprotected LM disease who underwent IVUS-guided PCI with a single stent crossing from LM into the LAD. Mean MSAs were 11.9 ± 2.5 mm² at the proximal LM, 10.1 ± 2.2 mm² at the distal LM, and 8.7 ± 1.9 mm² at the ostial LAD. In contrast to two-stent crush, MSA within the proximal LM emerged as the strongest independent predictor of 5-year MACE; a proximal LM MSA below 11.4 mm² was associated with significantly worse outcomes, while distal LM and LAD ostium MSA each had limited predictive ability in isolation. Considering these data together, Kim proposed a refined, minimal “6-8-11” framework for IVUS-guided LM PCI that is tailored to the procedural strategy rather than applied uniformly across segments. In a two-stent strategy, the priority is to avoid underexpansion at both branch ostia, targeting LAD MSA ≥ 8.3 mm² and LCX MSA ≥ 5.7 mm² (rounded “6 and 8”), whereas in a one-stent crossover, the focus shifts to securing a large proximal LM, with a target MSA ≥ 11.4 mm² (rounded “11”). This framework reframes optimization away from a single set of segmental cutoffs and toward strategy-specific targets that reflect where stent underexpansion is most likely to drive long-term events. Two key questions remain open. First, when the final MSA is small, does it truly reflect stent underexpansion, or does it simply reflect a small underlying vessel? Pre-stenting reference dimensions should be incorporated when interpreting absolute MSA thresholds. Second, can pre-stenting intracoronary imaging identify distal LM lesions that are better suited to an upfront two-stent approach? Preliminary data from the ASAN MAIN registry suggest that pre-stenting LCX IVUS parameters (minimal lumen area and plaque burden) may help predict LCX compromise after LM-to-LAD crossover, but prospective validation is needed. In conclusion, intracoronary imaging remains indispensable in LM PCI, and that MSA continues to be the key predictor of long-term success — but the segmental MSA targets that matter most depend on the chosen strategy. In a two-stent approach, attention should be focused on avoiding underexpansion at both branch outlets, whereas in a one-stent crossover, securing a large proximal LM is paramount. The proposed “6-8-11” criteria offer a pragmatic, strategy-specific minimum that updates the classic “5-6-7-8” rule for contemporary LM intervention. Meet the Experts Over Breakfast Left Main & Multi-Vessel Disease: Key Approaches Thursday, April 30, 7:20 AM ~ 8:25 AM Presentation Theater 1, Level 1

June 4, 2026 419

TCTAP 2026

OPTIMAL: IVUS- Versus Angiography-Guided Unprotected Left Main PCI

At TCTAP 2026, Adrian P. Banning, MD (Oxford University Hospitals NHS Foundation Trust, United Kingdom), presented the principal results of the OPTIMAL (OPtimizaTIon of Left MAin PCI With IntravascuLar Ultrasound) trial. PCI has become an established alternative to coronary artery bypass grafting (CABG) in patients with left main coronary stenosis of low-to-intermediate anatomic complexity. However, PCI for left main disease remains technically demanding, requiring optimal stent expansion and apposition, appropriate bifurcation technique, and adequate lesion coverage, each of which can influence long-term outcomes. OPTIMAL was an investigator-initiated study conducted across multiple centers in Italy, Spain, and the United Kingdom and sponsored by the European Cardiovascular Research Institute (Rotterdam, the Netherlands). Patients with unprotected left main disease deemed suitable for PCI were randomized in an open-label fashion to IVUS-guided or angiography-guided PCI. The primary end point was a patient-oriented composite outcome of death from any cause, any stroke, any myocardial infarction, or any revascularization at longest follow-up. Secondary outcomes included a device-oriented composite end point (cardiovascular death, target vessel myocardial infarction, or clinically indicated TLR) and a vessel-oriented composite end point (cardiovascular death, target vessel myocardial infarction, or target vessel revascularization). The trial was powered to detect superiority of IVUS guidance for the primary end point. Based on prior observational data and earlier randomized trials, investigators assumed a 2-year incidence of primary end-point events of 26% in the angiography-guided arm and 17% in the IVUS-guided arm, corresponding to a hazard ratio of 0.65. A sample of 800 patients was estimated to provide 80% power at a two-sided alpha level of 0.05, accommodating 6% attrition and up to 4% crossover. The primary analysis was conducted in the intention-to-treat population. Baseline characteristics were well-balanced between the two randomized group. The mean age was approximately 71 years and about 78% of patients were male in both groups. Acute coronary syndrome accounted for half of the initial presentations (NSTEMI ~39%, unstable angina ~10%), and diabetes mellitus was present in 36.6% of the IVUS-guided arm and 32.8% of the angiography-guided arm. The enrolled population had a relatively high anatomic complexity, with whole-population SYNTAX scores around 30. The strategy was predominantly target-lesion based rather than complete revascularization, reflected by fewer than two target lesions per patient on average, approximately 2.5 stents per patient, and a mean total stent length of 58 mm. Provisional bifurcation stenting was the dominant approach: definitive two-stent strategies at the left main bifurcation were used in less than 20% of patients, with culotte in 11%, crush or mini-crush in 5%, and T-technique in 3%. At a median follow-up of 2.9 years, the patient-oriented primary composite end point occurred in 135 patients (33.7%; 14.1 events per 100 patient-years) in the IVUS-guided PCI arm, compared with 125 patients (30.9%; 12.7 events per 100 patient-years) in the angiography-guided PCI arm. IVUS-guided PCI did not result in a significantly lower risk of the primary patient-oriented composite outcome compared with angiography-guided PCI (Hazard ratio, 1.11, 95% CI, 0.87-1.42). The device-oriented composite end point (cardiovascular death, target vessel myocardial infarction, or clinically indicated TLR) occurred in 90 patients (22.4%; 9.0 events per 100 patient-years) in the IVUS-guided arm and in 83 patients (20.5%; 8.1 events per 100 patient-years) in the angiography-guided arm. (Hazard ratio, 1.10, 95% CI, 0.82-1.49). The vessel-oriented composite end point (cardiovascular death, target vessel myocardial infarction, or target vessel revascularization) was observed in 97 patients (24.2%; 9.8 events per 100 patient-years) in the IVUS-guided arm and in 87 patients (21.5%; 8.6 events per 100 patient-years) in the angiography-guided arm (Hazard ratio, 1.14, 95% CI, 0.85-1.52). As with the primary outcome, no significant benefit of routine IVUS guidance was demonstrated for either device- or vessel-oriented end points. Several factors may help explain why a benefit of IVUS-guided PCI did not emerge in this trial. Participating sites had high left main PCI volumes, and operators had extensive expertise with both intracoronary imaging and angiographic assessment. This experience likely enabled a degree of "re-calibration" of angiographic measurements, narrowing the gap between the two strategies. Adherence to established procedural standards — particularly when the distal left main bifurcation was involved — together with the use of contemporary drug-eluting stent platforms and modern antithrombotic pharmacology may have further reduced the potential incremental contribution of routine imaging. The predominantly provisional bifurcation strategy, in which complex two-stent techniques were used relatively infrequently, also raises the possibility that the benefit of IVUS would be larger in settings dominated by more complex bifurcation approaches. In this randomized "real-world" trial of patients with unprotected left main coronary artery disease, IVUS-guided PCI did not result in a significantly lower risk of the primary patient-oriented composite outcome of death from any cause, stroke, myocardial infarction, or any revascularization compared with angiography-guided PCI at a median follow-up of 2.9 years. Further investigation is warranted to clarify whether IVUS guidance was underutilized in terms of triggering procedural optimization, whether highly experienced operators using angiography alone achieved exceptionally good results, whether the complex patient population and largely target-lesion approach masked an imaging benefit, and whether less complex bifurcation strategies inherently require less intracoronary imaging support. TCTAP Workshops Left Main & Multi-Vessel Disease: Modern Evidence and Real-World Strategy Thursday, April 30, 2:50 PM ~ 4:25 PM Main Arena, Level 1 Watch Session Video

June 4, 2026 376

TCTAP 2026

Are All DCBs the Same: Class Effect or Device-Specific?

At TCTAP 2026, Bruno Scheller, MD (University of Saarland, Germany) addressed a fundamental question in interventional cardiology: should drug-coated balloons (DCBs) be treated as a single therapeutic class, or does their performance depend critically on device-specific characteristics? Drawing on preclinical and clinical evidence spanning more than two decades, he argued that excipient choice, coating morphology, and tissue persistence were the true determinants of DCB efficacy — and that a class effect did not exist. Early Paclitaxel Data Defined the Concept He traced the DCB concept to his 2004 Circulation paper, which first demonstrated that paclitaxel applied to balloon catheters using the contrast medium iopromide (Paccocath technology) potently suppressed neointimal proliferation in porcine coronary models. Critically, this work showed that the excipient and coating procedure — not the drug alone — determined efficacy: the original crystalline Paccocath formulation significantly outperformed a modified amorphous coating variant in reducing neointimal area, establishing from the outset that not all DCBs would behave alike. Subsequent pharmacokinetic work (Circ Cardiovasc Interv, 2012) showed that paclitaxel remained detectable in porcine coronary tissue for months after a single balloon inflation, with a tissue half-life of approximately 1.7 months. This prolonged retention explained how a brief balloon contact could produce durable anti-restenotic effects — and set a high pharmacokinetic benchmark for any competing platform. Early Paclitaxel Data Defined the Concept As limus-coated balloons (LCBs) entered clinical development, the mechanistic differences between the two drug classes became increasingly relevant. Paclitaxel irreversibly stabilizes microtubules, blocking mitotic progression in a cytotoxic manner. Sirolimus, by contrast, acts through reversible mTOR inhibition — a cytostatic mechanism that requires sustained drug concentrations in the vessel wall to remain effective. Because sirolimus binding is reversible, limus-coated balloons must maintain sufficient tissue drug levels over a therapeutically meaningful period, making their delivery technology far more critical than for paclitaxel. Comparative tissue retention data (Sandesara, CRT 2026) illustrated this divergence: among paclitaxel-based platforms, the Agent DCB maintained measurable tissue concentrations through 120 days, while the sirolimus-based Selution and MagicTouch devices showed near-complete tissue clearance by day 90. He emphasized that this difference in tissue exposure translated directly into differences in biological efficacy. A further distinguishing feature of paclitaxel DCBs was the phenomenon of late lumen enlargement — a continued increase in minimal lumen diameter observed at follow-up angiography beyond the immediate post-procedural result (Clin Res Cardiol, 2015) — which had not been consistently replicated with limus platforms. Clinical trial data reinforced these device-specific differences. For in-stent restenosis, a combined analysis of two parallel randomized trials (Circ Cardiovasc Interv, 2022) and a subsequent comparison (JACC Cardiovasc Interv, 2025) showed broadly similar late lumen loss between specific SCB and PCB devices, suggesting that at least some limus platforms could achieve parity with paclitaxel DCBs in the restenosis setting. For de novo lesions, however, results were more sobering. A prospective randomized trial (Ninomiya et al., JACC Cardiovasc Interv, 2023) comparing Magic Touch SCB with SeQuent Please Neo PCB in small vessel de novo lesions found that the SCB failed to achieve non-inferiority for angiographic net lumen gain at 6 months (0.25 mm vs. 0.48 mm; P for non-inferiority=0.173). In the large-scale SELUTION de novo trial (Spaulding, CRT 2026; N>3,200), a sirolimus DEB strategy compared against drug-eluting stents showed a target vessel failure rate of 5.3% vs. 4.4%, and the per-protocol sensitivity analysis failed to confirm non-inferiority against the prespecified margin of 2.44%. Table 1. Paclitaxel-Coated Balloon vs. Limus-Coated Balloon: A Comparative Overview Paclitaxel (PCB) Limus (LCB) Mechanism microtubule stabilization mTOR inhibition Tissue binding Irreversible; single contact sufficient Reversible; prolonged exposure required Tissue retention Long-lasting (~1.7-month half-life) Rapidly cleared; formulation-dependent Late lumen enlargement Consistently demonstrated Not consistently observed Clinical evidence Established in ISR and de novo Comparable in ISR; unconfirmed in de novo PCB = paclitaxel-coated balloon; LCB = limus-coated balloon; ISR = in-stent restenosis. Conclusion He concluded that DCBs did not represent a class effect. Paclitaxel-coated balloons remained the standard for DCB therapy, with drug persistence that depended critically on excipient and coating procedure, and with demonstrated benefits including late lumen enlargement, preserved vasomotion, and potential stabilization or regression of atherosclerosis. Limus-coated balloons, by contrast, required prolonged tissue persistence due to reversible mTOR binding — yet current platforms varied widely in tissue kinetics and had not consistently replicated the late lumen enlargement seen with paclitaxel. Each DCB device, regardless of drug class, needed to be evaluated on its own merits. Hot Topics New DCB Strategy in Modern PCI Saturday, May 2, 8:30 AM ~ 9:55 AM Coronary Theater, Level 1 Watch Session Video

June 4, 2026 789

TCTAP 2026

PCI for Vulnerable Plaque: From PREVENT I to the Next Era of PREVENT II

At TCTAP 2026, Jung-Min Ahn, MD, PhD (Asan Medical Center, Korea) reviewed the evolving strategy of percutaneous coronary intervention (PCI) for vulnerable plaques. Bridging the gap between the landmark results of PREVENT I and the emerging non-invasive era of PREVENT II, Dr. Ahn outlined a new treatment paradigm for high-risk lesions. While the vulnerable plaque concept was introduced in the late 1980s with the assumption that thin-cap fibroatheromas (TCFA) mostly resided in mild stenoses, modern data demonstrates a higher incidence of ruptured plaques in 50% to 75% diameter stenoses. While a fractional flow reserve (FFR) greater than 0.80 generally justifies medical therapy alone, registry data shows a 3% to 4% cardiac event rate at 2 to 3 years. Furthermore, if these FFR-negative lesions contain high-risk features identified on optical coherence tomography (OCT), the event rate climbs significantly to around 19%. The PREVENT trial was designed to see if local treatment could prevent future events originating from these non-flow-limiting plaques. In PREVENT, vulnerable plaques were defined by criteria such as a minimum lumen area (MLA) of less than 4.0 mm², a plaque burden over 70%, or the presence of a TCFA or lipid-rich plaque. Preventive PCI significantly reduced the primary endpoint of target vessel failure at 2 years, with absolute risk differences maintained up to a 7-year follow-up. Patient-oriented composite outcomes—including death, myocardial infarction, and repeat intervention—were also significantly reduced by preventive PCI, dropping from 19.3% to 14.4% at 7 years. However, a critical caveat was that 97% of the lesions in PREVENT qualified based on morphological criteria alone. To refine patient selection, the PREVENT-NIRS subgroup analysis looked at 632 lesions and found that only 37% had a high lipid burden (maxLCBI4mm > 315). Crucially, preventive PCI significantly reduced event rates exclusively in these lipid-rich plaques, whereas there was no treatment difference between PCI and optimal medical therapy (OMT) in non-lipid-rich plaques. In multivariable models, lipid burden was the only independent predictor of clinical events, capturing the risk signals previously attributed to plaque burden and MLA. Despite these successes, the "great debate" surrounding preventive PCI for non-flow-limiting lesions is ongoing. Critics often cite the risk of overtreatment, the proven efficacy of newer intensive lipid-lowering therapies, and the lack of a sustained impact on hard clinical endpoints like mortality. Furthermore, the requirement for invasive diagnostic tests like OCT and intravascular ultrasound (IVUS) limits the widespread translation of these criteria into daily clinical practice. To overcome the limitations of invasive imaging, the field is rapidly advancing toward non-invasive assessment via coronary computed tomographic angiography (CCTA). High-risk plaques can now be identified by specific CT features: low-attenuation plaque (< 70 HU indicating a lipid-rich core), positive remodeling (remodeling index > 1.2), the napkin-ring sign, and spotty calcifications under 3 mm. This non-invasive approach forms the foundation of the PREVENT-2 Trial. The trial plans to randomize 2,500 patients evaluated by CCTA who exhibit at least moderate stenosis and two or more high-risk CT plaque features (Figure 1). Patients will be assigned to either an initial invasive strategy (coronary angiography and potential preventive PCI) or a conservative strategy (OMT alone), with investigators tracking major adverse cardiac events at 3 years. Figure 1. Study Design of the PREVENT II Trial. Conclusion The PREVENT trial demonstrated that preventive PCI for the non-flow-limiting lesions with vulnerable plaques significantly reduces target vessel failure and patient-oriented composite outcomes over seven years. Subgroup analysis further clarifies that lipid-rich composition is a superior independent predictor of future events compared to morphological markers like plaque burden or minimal lumen area. Moving forward, the PREVENT II trial utilizes non-invasive CCTA to identify high-risk markers to guide preventive PCI. Hot Topics Modern Approaches to Vulnerable Plaque: Imaging, Physiology, and Intervention Friday, May 1, 10:55 AM ~ 12:20 PM Valve & Endovascular Theater, Level 1 Watch Session Video

June 4, 2026 347

TCTAP 2026

Current Status and Recent Updates in Transcatheter Tricuspid Therapies in Asia-Pacific

At TCTAP 2026, Shih-Hsien Sung, MD, PhD (National Yang-Ming Chiao-Tung University / Taipei Veterans General Hospital, Taiwan) reviewed the current status and recent updates in transcatheter tricuspid therapies in Asia-Pacific. He emphasized that the field had moved beyond simply proving feasibility toward refined patient selection, anatomical assessment, and the development of systems of care capable of delivering durable clinical benefits. Growing Burden of Tricuspid Regurgitation in Asia-Pacific Tricuspid regurgitation (TR) was characterized as a significant and growing regional challenge. A Chinese hospital-based retrospective analysis of 134,874 patients identified moderate TR in 2.22% and severe TR in 1.39% of the cohort, with detection rates rising sharply in elderly patients and those with reduced left ventricular ejection fraction (Cardiology, 2019). In South Korea, a nationwide registry found that 22.7% of valvular heart disease patients had moderate or severe TR, with secondary TR accounting for 90.2% of cases (J Cardiovasc Imaging, 2023). In Japan, TR was identified in 20.0% of patients with common valvular disorders, yet only 3.5% of all valvular heart disease patients underwent any invasive procedure in 2019 — highlighting the profound treatment gap (J Cardiol, 2023). A 2025 JACC Asia consensus review noted that the Asia-Pacific region exhibited distinct etiologic patterns compared to Western registries, including a higher prevalence of degenerative and rheumatic causes, more frequent late clinical presentations, significant disparities in healthcare financing across countries, and a limited landscape of approved devices. Table 1. Current Transcatheter Tricuspid Device Availability Across Asia-Pacific Device China HK SAR Taiwan Japan Korea Aus/NZ India Thailand Singapore TriClip ✓ ✓ ✓ ✓ – ✓ – ✓ ✓ K-Clip ✓ ✓ – – – – – – – Lux Valve Plus Tr Tr Tr – – Tr – Tr Tr TricValve Tr ✓ Tr – – Tr ✓ ✓ ✓ ✓ = commercially available; Tr = clinical trial only; – = not available. (JACC Asia. 2025;5(3 Pt 2):405-423) T-TEER: The Current Regional Workhorse Tricuspid transcatheter edge-to-edge repair (T-TEER) remained the primary transcatheter platform across Asia-Pacific. The two-year results from the TRILUMINATE Pivotal trial (Circulation, 2025) confirmed sustained benefits, with the device arm showing a 27% reduction in annualized heart failure hospitalization rates compared to medical therapy (0.19 vs. 0.26 events/patient-year; p=0.02). Early Asian real-world data from four centers (JACC Asia, 2026; Kent So et al.) involving 106 patients (mean age 76.1 years; 89% functional TR) demonstrated significant TR reduction and improvement in NYHA functional class at 30 days, with 0% cardiovascular mortality and 0% TV reintervention. He cautioned that T-TEER success was highly dependent on precise anatomical assessment. The APSC consensus (JACC Asia, 2026) identified favorable anatomical criteria — coaptation gap ≤7 mm, anteroseptal jet, trileaflet morphology — and unfavorable features including gaps ≥10 mm, leaflet thickening or perforation, and anteroposterior jet location. Data from the FATE registry (JACC Cardiovasc Interv, 2026) further showed that among 123 device-related T-TEER failures (5.4% of 2,278 procedures), redo intervention achieved significantly lower residual severe-to-massive TR than medical management (28.1% vs. 71.2%; p=0.001). TTVR: The Emerging Next Wave Transcatheter tricuspid valve replacement (TTVR) was presented as the defining next frontier, particularly for patients with massive or torrential TR or anatomies unsuitable for leaflet-based repair. The TRISCEND II trial (JACC Cardiovasc Interv, 2026) reported win ratios of 1.64 and 2.20 for severe and massive/torrential TR subgroups, respectively, at 18 months. TR reduction to ≤mild at one year was achieved in approximately 95% of TTVR patients, versus ~2% with medical management alone. Heart failure hospitalization at 18 months favored TTVR in the massive/torrential subgroup (23.6% vs. 38.8%), though rates of pacemaker implantation and severe bleeding were higher in the device arm. Regional experience with the Lux-Valve Plus — a non-radial-force transjugular TTVR system — showed device success of 96.87% and procedural success of 95.83% in the TRAVEL II study (N=96), with all-cause mortality of 4.17% at one year (JACC Asia, 2025). In patients with cardiac implantable electronic devices (CIEDs), TR reduction and functional improvement were equivalent to non-CIED patients at 30 days, and no lead revisions were required at six months. Acute hemodynamic instability (AHI) emerged as a key safety consideration following TTVR, occurring in 8.5% of 200 consecutive patients in the CESAR-TR Registry (JACC Cardiovasc Interv, 2026), with an associated in-hospital mortality of 35%. Independent risk factors for AHI included elevated pulmonary capillary wedge pressure, reduced LVEF, impaired renal function, and a low TAPSE/mPAP ratio. Table 2. Short-term In-patient Outcomes: T-TEER vs. TTVR in Asia-Pacific Outcome T-TEER (n=136) TTVR (n=38) P Value 30-day residual TR ≤mild 35.5% 96.1%

May 28, 2026 390

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