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TCTAP 2023

Physiologic Approach for Non-LM Bifurcation Lesions

A recent lecture at TCTAP 2023, ¡®All Bifurcation PCI¡¯ highlighted the clinical relevance of side branches and emphasized the importance of weighing risk and benefit when guiding the bifurcation percutaneous coronary intervention (PCI) strategy. Bon-kwon Koo, MD (Seoul National University Hospital, Korea), introduced a novel algorithm for a physiological approach, developed collaboratively by the Korean, Japanese, and European Bifurcation Clubs. This algorithm aims to provide a comprehensive framework for managing coronary bifurcation lesions. According to the algorithm, if the side branch is deemed not clinically relevant, the primary objective is just to maintain thrombolysis in myocardial infarction (TIMI) 3 flow in the side branch. This determination is primarily based on angiographic assessment. He also introduced the SNuH score, which was developed a decade ago and incorporated into the Bifurcation Academic Research Consortium (Bif-ARC) in 2022 to assess the clinical significance of side branches. The score takes into account vessel size (diameter >2.5 mm), the number of diagonal branches (¡Â2), and the absence of branches below the target branch. Furthermore, a simple decision tree approach was also introduced which is based on the analysis of over a thousand cases (Figure 1). It revealed that only 15% of side branches supply more than 10% of the entire myocardium. However, the likelihood of a diagonal branch supplying more than 10% of the entire myocardium varies according to the coronary anatomy. If a single diagonal branch is present without left circumflex dominance, the likelihood of supplying more than 10% of the myocardium rises to 74%. Figure 1. Decision tree approach for significant side branch In cases where the side branch is clinically relevant, the proposed algorithm by Korean, Japanese, and European Bifurcation Clubs recommends provisional side branch stenting. Following stenting, functional assessments such as fractional flow reserve (FFR) or non-hyperemic methods are required. Additional side branch intervention is indicated if these values fall below the thresholds. In a previous retrospective analysis, FFR data of jailed left circumflex artery (LCX) after left main-left anterior descending artery (LM-LAD) crossover stenting revealed that a low FFR value (

June 20, 2023 4294

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TCTAP 2023

Statistical and clinical interpretation of the "PROTECTED-TAVR" trial and my take-home messages

According to Samir R. Kapadia, MD (Cleveland Clinic, USA), the trial revealed a lower incidence of disabling strokes with protection, and the procedure itself was safe; hence this signifies that it is not the end of the story. Stroke remains frequent post-transcatheter aortic valve replacement (TAVR), in about 3% to 5% at 1 year, with 50% of events occurring within 3 days and being procedure-related. Stroke post-TAVR is probably under-reported, and its real frequency increases when a neurologist is involved in patient assessment. Half of the strokes are covert events and could have a delayed impact on depression, cognitive function, and quality of life. Though prior studies have shown that deploying the Sentinel system captures debris in nearly all patients undergoing TAVR and have suggested that doing so may reduce stroke in intermediate- or high-risk cohorts, definitive evidence of a reduction in events remains elusive. Those who were hoping that the PROTECTED-TAVAR trial would give a clear-cut result and bring closure to the question of whether cerebral embolic protection (CEP) reduces stroke in patients undergoing TAVR were disappointed when the findings were published on NEJM in September 2022. Figure 1. Comparison in the rate of strokes within 72 hours and prior to discharge The trial did not meet its primary endpoint, failing to demonstrate a significant difference in the rate of stroke within 72 hours of the procedure or prior to discharge¤Ñ2.3% with the use of the Sentinel CEP system (Boston Scientific) versus 2.9% without (P = 0.30) (Figure 1.). But that¡¯s not the end of the story, according to him, a global principal investigator, because with CEP there was a lower rate of disabling stroke, a secondary endpoint for which the trial was not powered (0.5% vs 1.3%; P = 0.02). He told TCTAP 2023 that the trial also showed that the using of CEP was safe with no major complications, and that stroke was an unpredictable event¤Ñno specific factors that could be used to identify a patient group most likely to benefit from protection emerged. ¡°I wouldn¡¯t say it¡¯s negative,¡± he said about the trial, adding that it was possible that a larger study could have shown a significant advantage for protection on the primary endpoint. Moreover, he added, ¡°Disabling stroke is a more meaningful outcome for patients.¡± The use of a CEP device during TAVR did not lead to a significantly lower incidence of periprocedural stroke. Based on the 95% confidence interval around this outcome, however, the results may not rule out a benefit of CEP during TAVR. He concluded that the use of protection with the Sentinel device should be considered for all patients undergoing TAVR to reduce disabling strokes (Figure 2). The number needed to treat for this purpose was 125. Figure 2. A take-home message from his lecture Hot Topics Game of Thrones, TAVR vs. SAVR Sunday, May 7, 4:10 PM - 5:30 PM Valve & Endovascular Theater, Vista 1, B2 CHECK THE SESSION

June 20, 2023 3166

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TCTAP 2023

My 30 Years Story - Caring for Patients with Symptomatic Vascular Disease

John Robert Laird, Jr. MD (Adventist Heart & Vascular Institute, USA), shared his journey as a cardiologist in search of surgical strategies for symptomatic vascular disease. ¡°When reflecting on my past 30-plus years of peripheral intervention as a cardiologist, I couldn't help but think about the people that helped me along the way including my early mentors Dr. Christopher White, Stephen Ramee, and Tyrone Collins at Walter Reed Army Medical Center who were mentors during my cardiology fellowship and first introduced me to peripheral intervention, and then the group at the Washington Hospital Center and Cardiovascular Research Foundation where my colleagues and mentors in my early years as a practicing Interventional cardiologist¡¦(Figure 1).¡± Figure 1. Group members of the Cardiovascular Research Foundation in the early years During his early career, from 1987 to 1990, only balloon angioplasty was available. There were no FDA-approved stents, other devices, or as well as dual antiplatelet therapy. At that time, technical success rates were only 80 to 85% with balloon angioplasty. Problems with acute dissection and elastic recoil made acute vessel closure in 3 to 8% of cases, with significant consequences that were a need for emergency backup bypass surgery were 2 to 5% of cases. Restenosis rates even with successful angioplasty initially were 30 to 50% with balloon angioplasty, so those good old days were not so good. When it comes to iliac artery angioplasty, the results revealed around 90% in 1-month clinical success, but a significant drop off in patency over time-related to restenosis and to disease progression in the iliac arteries. Then, there was a lot of enthusiasm about the new devices that were introduced in the early 1990s including the atherectomy devices and stents. When the stent era began in the 1990s a time frame, the original Palmas 308 iliac balloon stent was presented as 30 mm in length, expandable tubular slotted stent, and could be expanded from 8 to 12 mm in diameter (Figure 2). Figure 2. Equipment needed for the iliac artery stenting Over the ensuing years, continued improvements were observed with our stents, both, balloon-expandable and self-expanding stents, and covered stents for iliac artery use and with a good technique such as using intravascular ultrasound guidance. The long-term results of the iliac artery stenting are remarkably good with 15-year primary and secondary patency rates that were over 90%, and we could treat very complex cases such as chronic occlusions (CTO) of both two iliac arteries. As a consequence of excellent angiographic results and good clinical outcomes, we've gone from an era of the bifemoral bypass which was a very commonly performed procedure to an era where it's a very rarely needed procedure because of the excellent results we achieved with treatments in the iliac artery endovascular treatments in the iliac arteries. Superficial femoral artery (SFA) disease has been much more challenged due to the nature of the disease with diffuse, long, and heavy calcified lesions associated with disease of the infra-popliteal runoff vessels and then the complex mechanical forces that complicate the placement of endovascular prostheses. Because of these challenges, we've seen a host of different technologies, multiple different balloons such as hot balloons, cold balloons, cutting balloons, scoring balloons, and more recently drug-eluting balloons (DEB). There are a whole host of CTO devices that have been developed laser as well as atherectomy devices and a variety of different stents, including, standard laser-cut nitinol stents, covered stents, a woven nitinol stent, and most recently paclitaxel-eluting stents for the SFA and popliteal arteries. Probably the biggest advance that we've undergone procedures in the SFA has been the advent of the DEB. This was the initial paper from 2004 by Dr. Sheller and Dr. Speck who were able to demonstrate that if you took paclitaxel and mixed it with iodinated contrast, you could then coat a balloon and allow the paclitaxel to come off the balloon and effectively deliver the drug into the vessel wall to inhibit subsequent new intimal proliferation. He was one of the co-principal investigators for the impact SFA drug-coated balloon trial where we saw three years by duplex ultrasound dramatically better results with the Impact-Admiral drug-coated balloon compared to standard balloon angioplasty. We learned better angioplasty techniques because DEB uses long balloon inflations and appropriately sized balloons to avoid geographic mismatch. We could see outstanding results even in complex morphologies in the SFA and popliteal arteries. And we now have data out to five years from the randomized trial as well as the global registry showing sustained benefit with Impact-Admiral drug-coated balloon for complex lesions in the SFA. Regarding better devices for calcium, atherectomy devices can be used in a very complex calcified lesion followed by DEB angioplasty. The woven nitinol stent from Abbott Supra stent is an excellent stent for complex calcified lesions, particularly in the popliteal artery where if we use a proper technique, we can get outstanding and good durable results. More recently, we have shockwave intravascular lithotripsy which has been demonstrated to be effective in multiple vascular beds including the SFA and popliteal artery as noted in the Disrupt PAD III study less need for stents and better patency when shockwave intravascular lithotripsy was used. Probably one of the most exciting advances again over the past 30 years has been the significant improvements and techniques for limb salvage in patients with complex infra popliteal occlusive disease, distal and multi-vessel intervention, pedal and tibial access, advanced CTO techniques with controlled antegrade and retrograde subintimal tracking (CART), reverse CART and Rendezvous techniques, recanalization through collaterals, plantar artery recanalization, and more recently transcatheter arterialization of the deep veins. About 25 years ago we would never have occurred to puncture one of the distal pedal vessels trying to a retrograde crossing of tibial occlusions, but now that has become commonplace. The importance of what we do for our patients, how significant an impact it is to save someone's leg, and how important work really is highlighted. Hot Topics EVAR, TEVAR, Peripheral Monday, May 8, 4:00 PM - 5:20 PM Presentation Theater 1, Vista 3, B2 CHECK THE SESSION

June 13, 2023 2801

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TCTAP 2023

The MitraClip Shows Promising Results in 5-Year COAPT Trial for Heart Failure Patients

Gregg W. Stone, MD (Mount Sinai Healthcare System in New York City, USA), discussed the final 5-year results of the COAPT trial, which examined the effectiveness of the MitraClip in patients with secondary mitral regurgitation (MR) and heart failure on May 8th at TCTAP 2023. Considered the largest randomized trial to date for patients with MR, the COAPT trial involved 614 heart failure patients who were already receiving guideline-directed medical therapy (GDMT). These patients experienced moderate to severe MR, leading to left ventricular dilatation and mitral leaflet tethering caused by papillary muscle displacement. The trial aimed to determine whether addressing the underlying abnormal left ventricle would improve patient outcomes. The participants were randomly assigned to receive either GDMT alone or treatment with the MitraClip. Earlier publications presented the 2-year results, which revealed a substantial reduction of approximately 50% in heart failure hospitalizations (HFH) among patients receiving medical therapy. The recent 5-year results, published in a NEJM, demonstrated a sustained 50% reduction in HFH. Specifically, the patients treated with GDMT alone experienced 447 hospitalizations (approximately two per patient), while those treated with the MitraClip had 314 HFH in 151 patients, resulting in an average reduction from 57% to 33% per year. This marked a statistically significant overall reduction of 47% in hazards. The trial also prioritized safety outcomes, employing a composite measure recommended by the FDA that encompassed device-specific events and progressive heart failure necessitating a heart transplant. The results indicated that within the first year, the measure remained below 12%, achieving a rate of 3.3%. Moreover, only four device-related events (1.4%) occurred in the MitraClip group. The MitraClip procedure is well-known for its safety, and this analysis further substantiated its favorable safety profile. Extending the safety assessment to one year, no abnormal safety events related to the MitraClip, such as device detachment, embolization, endocarditis, severe mitral stenosis requiring surgery, or any other device-related complications, were reported in the MitraClip group. An analysis of the composite outcome of death or HFH demonstrated a significant 47% reduction at the 5-year mark for patients who received the MitraClip in comparison to GDMT alone (Figure 1). Importantly, this reduction remained consistent across all pre-specified subgroups, including age, gender, surgical risk, ventricular size, and other factors analyzed. When examining the time to the first HFH, a Kaplan-Meier analysis revealed a remarkable 51% reduction. Notably, the majority of this reduction occurred within the first three years, after which no significant differences were observed between the two groups. Regarding all-cause mortality, the trial demonstrated a notable absolute reduction of 10% and a relative reduction of 28% over the 5-year duration. However, a landmark analysis unveiled that the mortality reduction was primarily observed within the first two years, with minimal differences between years two and five. This observation could be attributed to the crossover permitted in the trial, whereby patients in the control group who survived for two years and still exhibited severe MR became eligible for treatment with the MitraClip. He explained, ¡°I think that's a really important secondary implication of this study. Waiting until the patients have been observed for several years is futile because a lot of them are going to die every single year. You can prevent a lot of those deaths and reduce HFH by identifying appropriate patients for the MitraClip treatment despite optimal GDMT as soon as possible.¡± In conclusion, the 5-year results of the COAPT trial provided promising evidence regarding the efficacy of the MitraClip in heart failure patients with secondary MR. The findings demonstrate that transcatheter edge-to-edge repair with the MitraClip is safe. Figure 1. Death or HFH after crossovers Hot Topics Mitral & Tricuspid Valve Therapy Monday, May 8, 11:10 AM - 12:20 AM Valve & Endovascular Theater, Vista 1, B2 CHECK THE SESSION

June 13, 2023 4566

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TCTAP 2023

Optimal MSA for LM Crush Technique: New Criteria Any Difference in Any 2 Stent Technique?

Jung-Min Ahn, MD, PhD (Asan Medical Center, Korea), showed the relationship between Left Anterior Descending (LAD) and Left Circumflex (LCX) depending on new criteria describing how to optimize two stents for Left-Main (LM) bifurcation stenting technique. For the bifurcation lesion of left main coronary artery disease (LMCAD), a simple crossover of the LM to LAD artery has been considered as a default strategy. ¡°However, there are many cases we cannot avoid two-stenting at bifurcation lesions,¡± he said . Actually, in many trials about LMCAD including the PRECOMBAT, EXCEL, and NOBLE trials, more than one-third to up to half of patients received the two-stent technique (Figure 1). Even in the EBC-MAIN trial, which favored one-stenting, about 22% of patients in the provisional stenting group received two-stenting (Figure 2). Therefore, we should know how to optimize two stents for LM bifurcation stenting technique to improve the clinical outcomes of patients with LMCAD. Figure 1. Two Stent Technique in rRandomized Trials Figure 2. Randomized Trials for True LM Bifurcation In 2011, Kang et al. reported LM intravascular ultrasound (IVUS) minimal stent area (MSA) criteria based on the result of a total of 403 patients treated with LM percutaneous coronary intervention (PCI) (Figure 3). However, the previous study included a heterogeneous group of patients, and therefore, we needed specific MSA criteria for the LM crush technique based on the long-term follow-up data. Also, the EXCEL and Spain Registry Criteria suggested a bigger MSA compared with the LM IVUS MSA criteria. Figure 3. LM IVUS MSA criteria ¡°So, we needed new MSA criteria for the LM crush technique,¡± he said (Figure 4). Figure 4. LM IVUS Optimization Criteria ¡°We included a total of 292 patients with unprotected LMCAD treated with crush technique who had completed post-stenting IVUS and analyzed a major adverse cardiovascular event (MACE), a composite of death, myocardial infarction, or repeat revascularization (Figure 5).¡± Figure 5. Optimal MSA Criteria for LM Crush Technique Based on Long-Term (5-year) Clinical Outcomes ¡°Based on the 5-year MACE outcomes, we determined the best cut-off value to predict the 5-year clinical outcomes,¡± he said (Figure 6). Figure 6. ROC Curve Analysis ¡°LM did not show any association between LM MSA and MACEs, because LM MSA was large enough not to occur any cardiovascular events (Figure 7, 8). However, the MSA of LAD and LCX was linearly associated with MACEs (Figure 9). So, according to the aforementioned criteria, there was no significant difference in clinical outcomes between LM MSA >11.8 mm2 and LM MSA

June 08, 2023 4660

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TCTAP 2023

TAVR Techniques in Bicuspid Anatomy - Valve Selection, Sizing, and Positioning

TAVR Technique in Bicuspid Anatomy, Jung-Min Ahn, MD, PhD (Asan Medical Center, Korea), stressed not to do oversizing in bicuspid aortic valves (BAV) patients using the self-expandable valves (SEV). ¡°For BAV trans-catheter aortic valve replacement (TAVR), undersizing is safe and effective when considering calcification and annulus shape.¡± he said. He explained how to determine sizing in BAV TAVR according to the amount of calcification and its risk of rupture at the 28th TCTAP 2023 on May 7. In the previous STS/ACC TVT Registry, using Sapien 3 valve, BAVs and tricuspid aortic valves (TAVs) were not found to be different in terms of 1-year mortality or stroke, and Evolut R had no different outcomes for all-cause mortality. Recent registry data comparing the Sapien XT and CoreValve devices showed no difference in all-cause mortality after 2 years of follow-up. Additionally, the BEAT registry found no difference in mortality between the Sapien 3 and Evolut R devices, but the former was associated with a higher risk of annulus rupture, while the latter was associated with significant paravalvular leakage (PVL). He pointed to the BAVARD registry (Figure 1). It was found that about 90% of BAVs were of the tubular or flare type, which required annulus sizing without consideration above the annulus. Severe aortic valve calcifications, such as severe asymmetric calcification, calcified raphe, and left ventricular outflow tract (LVOT) calcification, are also associated with higher procedural risk and long-term mortality, and the optimal device sizing should be adjusted for the calcification volume. Figure 1.Sizing of BAV TAVR by the BABARD registry According to him, undersizing rather than oversizing is safe and effective in treating bicuspid aortic stenosis. He cited their Sapien 3 registry findings, which showed that compared to TAVs with 110% oversizing, BAVs required only about 105% oversizing during TAVR (Figure 2). Figure 2.Comparison of BAV and TAV oversizing from the Sapien 3 registry He stated the following conclusion as below (Figure 3). Figure 3. Optimal TAVR by BEV for BAV Hot Topics NEW TAVR Sunday, May 7, 5:30 PM ~ 6:30 PM Valve & Endovascular Theater, Vista 1, B2 CHECK THE SESSION

May 30, 2023 2523

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TCTAP 2023

Contemporary Trends in Aortic Stenosis Management - Legend's Perspective

Aortic stenosis (AS) should be thought of as a lifelong journey disease, and previous traditional notions of AS should be modernized and altered. Martin Leon, MD (Columbia University Irving Medical Center, USA), opened the 28th TCTAP 2023 with a Keynote lecture that discussed the contemporary trends in AS management. He emphasized that AS should be thought of as a lifelong journey disease, not just focusing on the index procedure itself, but the upstream and downstream development for this therapy is critical. Prior to the index procedure, new diagnostic methods have been developed, including an electrocardiogram (ECG) algorithm using artificial intelligence (AI) machine learning, which has shown high sensitivity and specificity in diagnosing left-sided valve diseases ¡°We also believe that upstream thinking requires an understanding that our previous traditional notions of AS should be modernized and should be altered.¡± He stressed the importance of understanding the patient's lifelong journey upstream, and how our traditional notions of AS should be modernized and altered. He argued that in addition to the traditional concepts of AS severity, it is necessary to subdivide severe AS according to the degree of cardiac damage and that even if asymptomatic, the prognosis varies depending on the cardiac damage (Figure 1). Figure 1. Staging classification in severe AS He also introduced the conceptual framework of upstream AS treatment, which aims to delay disease progression and shift clinical research efforts from late-stage reactive aortic valve replacement (AVR) to early-stage preemptive AVR and other complementary therapy approaches. He discussed several clinical trials looking at earlier management and follow-up for AS, including surgical trials and transcatheter studies. He suggested the upstream treatment not only for patients with asymptomatic severe AS but also for patients with at-risk predictors in moderate AS (Figure 2). Figure 2. The framework of upstream AS treatment ¡°Now after the index procedure, we need to be also concerned about downstream considerations, particularly AV valve durability and adjunct to pharmacotherapy.¡± He also explained the importance of downstream considerations, such as AV valve durability and adjunct pharmacotherapy. Although the incidence rate of bioprosthetic valve failure is not high, it does occur, so new materials to overcome it have been introduced. ¡°We believe that these trials (e.g., pharmacotherapies for AS) have been delayed but are now beginning to resurface with many new potential therapeutic targets and exciting new clinical trial methodologies.¡± Although the pharmacotherapies that slow down the progression of AS have not yet been discovered, efforts are being made to develop new drug treatment methods through the improvement of new treatment targets or research methods (Figure 3). Figure 3. Treatment strategy by AS severity grading and cardiac staging Finally, the lecture ended with him saying that the treatment of AS is a lifelong journey that requires treatment from various perspectives and aspects, such as earlier diagnosis, preemptive treatment, improvement of valve durability, and improvement of pharmacotherapy. Opening of TCTAP 2023 & Keynote Lectures Sunday, May 7, 9:30 AM - 10:16 AM Main Arena, Walker Hall, Level 1 CHECK THE SESSION

May 30, 2023 3404

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TCTAP 2023

Catheter-Based Strategies to Treat Tricuspid Valve Disease

During the Hot Topics session on May 8th at TCTAP 2023, James Flaherty, MD (Northwestern University Feinberg School of Medicine, USA), shared the broad overview and updated catheter-based strategies for tricuspid valve regurgitation. Functional tricuspid regurgitation (TR) is a progressive disease with a time interval of 5¡¾3 years from mild to moderate/severe regurgitation. If left untreated, it can lead to the enlargement of the right atrium and ventricle, as well as the development of heart failure. One year survival rate with severe TR reaches up to 64%. Historically, isolated tricuspid valve operations had rarely been performed due to high operative mortality (9%) and morbidity (42%) based on the STS database. To overcome the limitation of surgical treatment, several options of transcatheter-based approaches have been tested over the last decades (Figure 1). Figure 1. Transcatheter tricuspid landscape First, transcatheter edge-to-edge repair (TEER) for TR The TRILUMINATE was a pivotal trial evaluating the safety and effectiveness of a transcatheter tricuspid valve repair system, the TriClip device, for the treatment of moderate-to-severe TR. It showed an adequate reduction of less than moderate TR, correlated with symptomatic improvement compared to medical therapy alone (KCCQ +12.3% vs. +0.6% at 30 days after the procedure). The PASTE trial tested the PASCAL transcatheter valve repair system showing similar results, TR reduction and symptomatic improvement. Second, the transcatheter tricuspid valve replacement (TTVR) system (EVOQUE device) The EVOQUE system is designed to replace the patient¡¯s native tricuspid valve with a prosthetic valve that is inserted using a catheter. The TRISCEND trial and global registry showed a high implant success rate of 96.2%, the survival rate of 90.1%, and significant and sustained TR reduction with 97.6% of patients with mild or trace TR at 1 year. Third, annuloplasty The Edwards Cardioband Tricuspid Valve Reconstruction System Early Feasibility study enrolled 37 patients who had severe functional TR with NYHA class III/IV (65%). There was a progressive reduction of TR, from 44% of less than moderate TR at 30 days to 75% at 1 year. Lastly, he pointed out several unanswered questions about transcatheter tricuspid valve therapies, including the appropriate timing for intervention, device durability, and anti-coagulation after TTVR. Hot Topics Mitral & Tricuspid Valve Therapy Monday, May 8, 11:10 AM - 12:20 AM Valve & Endovascular Theater, Vista 1, B2 CHECK THE SESSION

May 24, 2023 2173

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TCTAP 2023

Insight from All Data of Left Main Revascularization (MAINCOMPARE, SYNTAX, PRECOMBAT, NOBLE, EXCEL)

At TCTAP 2023, Duk-Woo Park, MD, PhD (Asan Medical Center, Korea), shared insights from the MAINCOMPARE, SYNTAX, PRECOMBAT, NOBLE, and EXCEL trials and emphasized the importance of discussing the potential benefits, advantages, and disadvantages of the procedures with the cardiac surgeon. In the past two decades, several trials have been conducted to study left main and multi-vessel disease, including the SYNTAX, PRECOMBAT, EXCEL, and NOBLE trials. These trials have shown significant progress in both percutaneous coronary intervention (PCI) and bypass surgery for these conditions. While the surgery was consistently shown to be better for multi-vessel disease, there were differences in primary endpoints for left main disease among the trials. The Asan team conducted several registries and clinical trials, including the MAIN-COMPARE registry in NEJM, the PRECOMBAT for left main, and the BEST for multi-vessel disease. Recently, the team performed a 10-year follow-up on the PRECOMBAT trial, which showed no statistical difference in the primary endpoint but did reveal a difference in ischemic-driven target vessel revascularization (TVR). The controversy surrounding left main and bypass surgery is related to the EXCEL trial, where a mortality difference was observed but the primary endpoint of up to five years had some crossover with no statistical difference. An individual participant data (IPD) meta-analysis was conducted and published in the Lancet journal, which showed no difference in overall mortality between PCI and coronary artery bypass graft surgery (CABG) up to 5 years and up to 10 years in the SYNTAX and PRECOMBAT trials (Figure 1). Figure 1. Summarized of IPD meta-analysis of PCI versus CABG in left main coronary artery disease (LM CAD) The updated ACC guideline recommends bypass surgery for left main disease as a Class I recommendation, while PCI could be optional and is a Class IIa recommendation. The ESC has not yet updated its guidelines, which still recommends bypass surgery as a consistent Class I and PCI as a Class I, IIA, or III according to the SYNTAX category. There are still unmet needs, such as no further clinical trial comparing PCI and bypass surgery for left main being planned. The definition of myocardial infarction (MI) is still controversial, and complete and incomplete revascularization, the role of intravascular ultrasound (IVUS) and fractional flow reserve (FFR) in left main revascularization, and all-cause mortality versus cardiac mortality still require adjudication. Long-term follow-up data of big trials beyond five years up to 10 years is absolutely required, and the SYNTAX score is still questionable. One major issue is how to equalize left main PCI technique, as data shows that left main PCI procedures only make up 1.0% of all procedures in the United States over time in daily practice, which indicates a need for more operator training. The latest development in state-of-the-art PCI is the incorporation of imaging and physiology. This involves the use of IVUS and FFR, which play important roles in improving the outcomes of PCI. The future of PCI for left main disease could involve adopting this imaging and physiologic concept (Figure 2). Figure 2. Key component of state-of-the-art left main PCI with imaging and physiologic concept Hot Topics Left Main & Multi-Vessel (Concept Changes After ISCHEMIA) Sunday, May 7, 3:54 PM - 4:10 PM Presentation Theater 1, Vista 3, B2 CHECK THE SESSION

May 24, 2023 2027

Good People, Good Memories, Good Life!
Good People, Good Memories, Good Life!