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COMPLEX PCI 2023

Double Trouble or Double Success?
Upfront 2-Stent PCI for LM

Ho Lam, MD, FHKAM (Tuen Mun Hospital, Hong Kong, China), delved into the intricate world of percutaneous coronary intervention (PCI) for Left Main (LM) coronary artery bifurcation, providing a comprehensive exploration of the challenges and strategies inherent in this critical aspect of interventional cardiology. Emphasizing the nuanced nature of LM bifurcation PCI, he distinguished between simple and complex bifurcations. He stressed the importance of tailoring the approach to the specific characteristics of the lesion, advocating for a straightforward strategy in simple cases and a more individualized approach for complex bifurcations. Decision-Making Dilemma: Provisional vs. Upfront 2-Stent The heart of his presentation focused on the pivotal decision-making process between provisional and upfront 2-stent strategies. He vividly illustrated the risks associated with the provisional approach, particularly the closure of the left circumflex artery (LCX), emphasizing the potential for severe consequences. Incorrectly selecting a provisional approach, according to him, could lead to what he termed "double trouble," involving complications like the stressful wiring of LCX and increased stent thrombosis rates. Double Trouble: The Pitfalls of Wrongly Choosing Provisional He highlights the potential pitfalls if the provisional approach is incorrectly chosen. Closure of the vessel and the stressful process of wiring under challenging conditions are described. The presentation emphasizes the stressful nature of such procedures, requiring experienced operators to handle critical situations. Double Success: Benefits of Choosing Upfront Stenting Correctly Conversely, he outlined the advantages associated with correctly selecting and performing upfront 2-stent implantation, which he referred to as "double success." This approach, he highlighted, offers experiential learning opportunities in wiring, stenting, and imaging, along with cost reductions due to shorter cath lab times and decreased need for extended care. He also presented compelling data on stent thrombosis rates, showcasing the significantly lower incidence with upfront 2-stent procedures compared to provisional approaches that later required conversion to two stents. The lecture highlighted a 0.4% vs. 4.1% rate in definite or probable stent thrombosis over three years between the two methods. Reducing Costs and Achieving Full Revascularization: The Triple Success The lecture concluded with a strong emphasis on the pivotal role of operator experience and the ability to achieve full revascularization with a low residual SYNTAX score in Left Main PCI. His insights and data-driven approach contribute invaluable knowledge to the evolving landscape of LM bifurcation PCI, providing a comprehensive guide for interventional cardiologists navigating this intricate terrain. In summary, the choice between "Double Trouble or Double Success" in LM PCI is a spectrum that depends on patient characteristics, lesion complexity, and operator expertise. He suggests that, in general, the prognosis is largely determined by the severity of the LM lesion, making the correct decision pivotal for successful outcomes.

January 26, 2024 2203

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COMPLEX PCI 2023

Precision in Stent Sizing: Insights from Imaging-Guided LM PCI

Jung-Min Ahn, MD, PhD (Asan Medical Center, Korea), delivered an enlightening study on Left Main (LM) percutaneous coronary intervention (PCI), focusing on optimizing two-stent techniques for LM bifurcation stenting, especially in the Left Anterior Descending (LAD) and Left Circumflex (LCX) arteries. Delving into the challenge of determining significant LM disease, he highlighted the difficulty in measuring fractional flow reserve (FFR), particularly in cases involving distal downstream disease. His research demonstrated a significant correlation between the minimum lumen area (MLA) in the LM and FFR values. An MLA less than 4.5 showed a high positive predictive value for FFR values less than 80, providing a potential criterion for identifying functionally significant disease. His research contributes significantly to the field, considering the default strategy for treating bifurcation lesions in Left Main Coronary Artery Disease (LMCAD) has been a simple crossover from the LM to the LAD artery. However, instances where two-stenting cannot be avoided were noted. The ongoing debate on provisional versus two-stent techniques, as seen in trials like DK-CRUSH V and EBC-MAIN, emphasized the need for clearer criteria, especially as a substantial proportion of patients initially categorized for provisional stenting end up receiving two stents. The necessity for this approach is evident from various trials on LMCAD, including PRECOMBAT, EXCEL, and NOBLE, where a significant proportion of patients received two-stent techniques. Even in the EBC-MAIN trial, which generally favored one stenting, about 22% of patients in the provisional stenting group ended up receiving two stents, underscoring the importance of understanding how to optimize the two-stent technique for better clinical outcomes. Addressing the ambiguity in defining when to choose between the two techniques, he discussed the current lack of definitive criteria. While angiographic criteria have been suggested, the absence of Intravascular Ultrasound (IVUS) criteria remains a gap. He proposed integrating IVUS criteria into decision-making processes, referencing studies indicating the predictive value of minimal lumen area and plaque burden for functional outcomes. He revisited the criteria established by Kang in 2011 while exploring the optimization of two-stent techniques. Kang et al. (2011) reported on minimal stent area (MSA) criteria for LM intravascular ultrasound (IVUS) from a diverse group of 403 patients undergoing LM PCI. However, the study's heterogeneity called for more specific MSA criteria, particularly concerning the LM crush technique. It's noteworthy that the EXCEL trial suggested a larger MSA compared to the established LM IVUS MSA criteria. Emphasizing the necessity of refining these criteria, especially considering the heterogeneity of various stenting techniques, his recent analysis indicated that achieving larger minimum stent areas, particularly in the complex ostium of the Left Main, correlates with improved long-term outcomes. These findings offer potential benchmarks for optimizing stent size and contribute to the ongoing discussion on refining criteria for LM PCI. The lecture provided insights into the ongoing debate about event rates between simple crossover and two-stent techniques. He presented data from his center's registry, demonstrating that proximal Left Main stent area significantly impacts clinical outcomes. Larger minimum stent areas correlated with favorable long-term outcomes, challenging the conventional belief that simple crossover stenting inherently results in lower event rates. Addressing this gap, he presented new MSA criteria based on a study of 292 patients with unprotected LMCAD treated with the crush technique. This study focused on major adverse cardiovascular events (MACE), a composite of death, myocardial infarction, or repeat revascularization. His analysis revealed a linear relationship between MSA of LAD and LCX with MACEs. Larger IVUS-MSAs were associated with improved clinical outcomes, underlining the significance of this parameter in guiding interventions. He concluded his presentation by recommending optimal IVUS-MSA criteria for predicting 5-year MACE: 11.8 mm2 for the distal LM, 8.3 mm2 for the LAD ostium, and 5.7 mm2 for the LCX ostium. His findings stress the paramount importance of achieving an adequately large MSA under IVUS guidance during LM two-stenting procedures to mitigate adverse clinical events. These conclusions offer invaluable guidance for interventionists, enhancing the precision and effectiveness of treatment for patients undergoing LM two-stenting procedures.

January 19, 2024 2157

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COMPLEX PCI 2023

Celebration of LM PCI: Joy in Growth, Journeying Towards 25 Years

In an illuminating presentation at COMPLEX PCI 2023, Duk-Woo Park, MD, PhD (Asan Medical Center, Korea), provided a comprehensive overview of the growth of Left Main Percutaneous Coronary Intervention (PCI) over the last 25 years, delving into future perspectives while addressing the remaining challenges in this critical field. He presented a historical timeline of Left Main PCI, comparing two major procedures: the standard of care, Coronary Artery Bypass Graft (CABG) surgery, and the less invasive PCI treatment. Pivotal trials such as Syntax, PRECOMBAT, EXCEL, and NOBLE were highlighted, illustrating the comparative effectiveness of these interventions for Left Main and multivessel diseases. With Korea being a global leader in Left Main PCI, he traced back almost 25 years of history, mentioning early pioneers like Dr. Gudino and showcasing the first consecutive report of Left Main PCI at Asan Medical Center in 1998. The center's long-standing expertise and innovative techniques were instrumental in shaping the landscape of Left Main interventions. Addressing recent advancements, he highlighted a Lancet-published review by cardiac surgeon Mario Gudino, emphasizing the continuous revolution in both CABG and PCI procedures. This evolution includes advancements in drug-eluting stents,adjunctive drugs, and imaging- and FFR-guided PCI, leading to improved patient outcomes. He delved into long-term outcomes, discussing key trials like SYNTAX, PRECOMBAT, EXCEL, and NOBLE. He emphasized a recent combined individual patient data (IPD) meta-analysis, revealing that over 15 years, PCI and CABG showed no significant difference in mortality, with PCI demonstrating lower procedural complications and CABG having lower spontaneous myocardial infarctions. Providing insights into guideline updates, he discussed recommendations from both the American and European societies, underlining ongoing debates and controversies. He particularly addressed the ESC guideline's withdrawal of cardiac surgeon recommendations after the EXCEL trial. Future Directions: FATE-MAIN Trial and DEFINE-DM Trial Highlighting real-world practices, particularly in the Asian-Pacific region, he shed light on the preference for bypass surgery in cases with extensive non-LM coronary artery disease and diffuse three-vessel diseases. Conversely, PCI was favored for cases involving multivessel comorbidity. He introduced two upcoming trials shaping the future of Left Main PCI. The FATE-MAIN trial (Figure 1), involving over 40 Asian Pacific centers, will evaluate physiology-guided PCI versus conventional angiography-guided PCI. The DEFINE-DM trial (Figure 2) will focus on ischemic cardiomyopathy and diabetic patients, aiming to provide crucial insights into the remaining unmet issues. The presentation concluded by addressing persisting challenges in LM PCI, particularly in cases of ischemic cardiomyopathy with an ejection fraction below 40%. He highlighted two ongoing trials, STICH3C and DEFINE-DM, poised to provide insights into optimal revascularization strategies for these patient populations. Figure 1. FATE-MAIN Trial Study Design In the FATE-MAIN trial, we assume that the improved outcomes with FFR-guided PCI are likely a result of more judicious PCI whereby ischemia-inducing LMCA lesions are revascularized and non-ischemia-inducing LMCA lesions are treated with OMT alone. Figure 2. DEFINE-DM Trial Study Design In the contemporary clinical practice, the goal of PCI is to achieve complete functional revascularization of ischemic territories. Thus, the theoretical and practical concept of physiology-guided PCI will also work even in Left Main PCI setting. His lecture highlighted the rich history and advancements in Left Main PCI and outlined the current controversies and future directions, setting the stage for continued innovation in this crucial field of interventional cardiology.

January 19, 2024 1625

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SummitMD

OCTIVUS Trial Subgroup Analysis for Complex Coronary Lesions Revealed at TCT 2023

Do-Yoon Kang, MD, PhD (Asan Medical Center) presented the Key Analysis from the OCTIVUS Trial during the 35th TCT 2023 held at the Moscone Center in San Francisco, CA on October 23. At the TCT WorldLink East Asia Featured Clinical Science, Do-Yoon Kang, MD, PhD (Asan Medical Center, Korea), unveiled pivotal findings from the key subgroup analysis of the OCTIVUS trial for the treatment of complex coronary artery lesions. The OCTIVUS trial was a prospective, multi-center, randomized, open-label trial that compared Optical Coherence Tomography (OCT) and Intravascular Ultrasound (IVUS) in guiding Percutaneous Coronary Interventions (PCI) in a total of 2008 patients. Of those, this study compared OCT-guided PCI with IVUS-guided PCI in patients with complex coronary lesions in 1475 patients, including unprotected left main disease, bifurcation disease, aorto-ostial lesions, chronic total occlusions, severely calcified lesions, in-stent restenosis, diffuse long lesions, and multivessel disease. He highlighted the use of Cox proportional hazards models and overlap propensity-score weighting to adjust patient characteristics and reduce treatment selection bias. The mean age was about 65 years, and 21% were women. Lesion characteristics were similar in the two groups, although there was a lower proportion of left main disease and a lower mean SYNTAX score in the OCT group. Contrast dye used was greater, and total PCI time was shorter in the OCT-guided group. There was no difference in the rate of contrast-induced nephropathy between the two groups, but major procedural complications requiring intervention were less frequent in the OCT group (1.7% vs 3.4%; P = 0.03). The imaging devices showed no complications throughout the course of the study. Key findings revealed that OCT-guided PCI showed comparability to IVUS with the primary endpoint of a composite of cardiac death, target-vessel myocardial infarction (MI), or target-vessel revascularization over a median follow-up of 2 years (6.5% in the OCT group vs. 7.4% in the IVUS group; HR 0.87; 95% CI 0.59-1.29). The results remained steadfastly consistent between the groups, even after adjustments. Most secondary endpoints occurred at similar rates in the two groups, except that target-vessel MI was less common in the OCT group (0.8% vs 2.4%; P = 0.03). In subgroup analyses by lesion type, results were generally the same as in the overall analysis, except that in patients treated for in-stent restenosis, OCT guidance was associated with a lower rate of target vessel failure compared with IVUS guidance (10.5% vs 29.5%; HR 0.36; 95% CI 0.17-0.78). While presenting the findings, he astutely underscored the imperative of acknowledging the inherent constraints of the study. The number of primary-outcome events was lower than expected, and the impossibility of masking imaging modalities from patients and investigators could introduce bias. Additionally, he noted the potential for discrepancies in site-determined and core-laboratory measured imaging interpretation. In patients with complex coronary lesions, he formulated the following conclusions, OCT-guided PCI showed a similar risk of a composite of death from cardiac causes, target-vessel MI, or ischemia-driven target-vessel revascularization compared to IVUS-guided PCI during the median 2-year follow-up. However, owing to insufficient statistical power and inherent limitations from subgroup analysis, the overall finding should be hypothesis-generating, and further research is needed in this area. Do-Yoon Kang, MD, PhD

December 01, 2023 2874

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AP VALVES & SH 2023

14-Year¡¯s Journey of AMC TAVR

Seung-Jung Park, MD, PhD (Asan Medical Center, Korea), presents the 14-year journey of TAVR in the opening session during the 12th AP VALVES & STRUCTURAL HEART 2023 held at the Grand Walkerhill Seoul, South Korea on August 10. As of 2023, the 2020 ACC/AHA guideline recommends TAVR for severe symptomatic Aortic Stenosis (AS) patients over the age of 65, while those under 65 are considered for Surgical Aortic Valve Replacement (SAVR) based on their age. However, the 2021 ESC/EACTS guidelines recommend TAVR for patients over 75 years of age, with all other patients evaluated for either TAVR or SAVR based on their specific condition. Dr. Park now suggested that TAVR is the primary choice for patients in need of a tissue valve, with SAVR considered for those deemed unsuitable for the TAVR procedure. Asan Medical Center, which initiated TAVR procedures in 2010 and currently performs approximately 300 TAVR cases per year, totaling over 1500 cases, has achieved promising outcomes. These outcomes include procedural success rates of 99.5%, with low mortality (1.3%), stroke (0.3%), vascular complications (4.2%), permanent pacemaker insertion (6.8%), moderate to severe paravalvular regurgitation (0.4%), and more, showcasing the effectiveness of their approach. This success can be attributed to a collaborative heart team approach, a minimalist approach known as MAC (Monitored Anesthesia Care), and a meticulous AMC CT algorithm for device selection. The AMC CT Algorithm is a major key to achieving a procedural success rate of 99.5%. This algorithm can identify various anatomical factors, including annulus area, calcium distribution, and coronary height, which are measured to determine the size of the valve and its suitability for TAVR. The choice of TAVR device and balloon volume is determined by the level of calcium and other structural factors. The data from AMC¡¯s TAVR procedure show favorable 30-day and 1-year outcomes, including all deaths (1.5%, 8.4%, respectively), cardiac death (1.1%, 2.2%, respectively), and disabling stroke (1.3%, 1.4%, respectively). In conclusion, he emphasizes that TAVR has become the standard of care for patients with symptomatic severe aortic stenosis, regardless of age or specific cases. SAVR is considered primarily for patients who are unsuitable for TAVR. The data and experience of AMC presented to support the effectiveness of the heart team approach, the minimalist MAC procedure, and the CT algorithm for valve size selection, highlighting their key factors for success.

November 10, 2023 2880

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AP VALVES & SH 2023

RENOVATE Trial

The introduction of valve replacement surgery in the early 1960s dramatically improved the outcomes for patients with valvular heart disease. Currently, approximately 300,000 valve substitutes are implanted worldwide each year, with about half being mechanical valves and the other half bioprosthetic valves. This number is projected to rise to 850,000 per year by 2050. Bioprosthetic valves pose a higher risk of reoperation due to structural valve deterioration, whereas mechanical valves typically require lifelong anticoagulation to prevent thromboembolism, leading to an increased risk of hemorrhage. The risk-benefit ratio between mechanical and bioprosthetic valves has led American and European guidelines on valvular heart disease to consistently recommend mechanical valves for patients under 60 years of age due to their more favorable long-term survival rates in younger patients. Despite these recommendations, the use of bioprosthetic valves has significantly increased across all age groups over the past decades, mainly due to the advantage of avoiding long-term anticoagulation. In the current guidelines, oral anticoagulation using a vitamin K antagonist is recommended lifelong for all patients with mechanical valves. However, the use of vitamin K antagonists requires frequent blood testing, dosage adjustments, and restrictions on food, alcohol, and relevant drugs. To address these limitations, the Randomized, Phase II study to Evaluate the Safety and Pharmacokinetics of Oral Dabigatran Etexilate in Patients after Heart Valve Replacement (RE-ALIGN) trial was conducted. This trial aimed to compare the anticoagulation regimen between dabigatran and vitamin K antagonist(warfarin) in patients who had undergone mechanical heart valve replacement, evaluating the efficacy and safety of dabigatran, one of the non-vitamin K antagonist oral anticoagulants (NOACs), in patients with mechanical valves. Unfortunately, the trial was terminated prematurely due to an excess of thromboembolic and bleeding events among patients in the dabigatran group. Consequently, the current guidelines contraindicate the use of NOACs in patients with mechanical valves. Despite this setback, revisiting the RE-ALIGN trial has provided valuable insights for future clinical trials. The major limitations of the RE-ALIGN trial include dose adjustments of dabigatran aiming for a trough plasma level of at least 50 ng/mL, often administering the drug above standard dosages, inclusion of mitral mechanical valve replacement cases (29%), which entail much higher thrombogenic conditions than aortic valve replacement, enrollment of patients in the early phase of the postoperative period (

November 10, 2023 2020

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SummitMD

Advancements in Intravascular Imaging Explored at ESC 2023

AMSTERDAM, the Netherlands — The European Society of Cardiology (ESC) Congress 2023 has cast a spotlight on the evolving role of intravascular imaging (IVI) in percutaneous coronary intervention (PCI), revealing both the potential benefits and challenges associated with this advanced technology. Thus far, no definitive research has established the superiority of either technique. IVI is eagerly anticipated for its capability to enhance the precision of stent placement, reduce complications, and mitigate the risk of stent thrombosis. The medical community is abuzz with excitement, eagerly anticipating the transformative potential that IVI holds in the realm of interventional cardiology. The spotlight of the conference was on the groundbreaking OCTIVUS Trial, which meticulously categorized patients undergoing PCI between 2018 and 2022 into two cohorts based on the intravascular imaging device employed: 1,003 patients underwent intravascular ultrasound (IVUS), while 1,005 patients were guided by optical coherence tomography (OCT). The study meticulously compared and analyzed major clinical events occurring within one year, including myocardial infarction, ischemia requiring reintervention, or cardiac death. Remarkably, the results unveiled no statistically significant disparities in the incidence of major clinical events between the two groups, registering rates of 3.1% in the IVUS group and 2.5% in the OCT group. Similarly, intervention-related complications exhibited no substantial differences, standing at 3.7% and 2.2% respectively. Do-Yoon Kang, MD, PhD (Asan Medical Center, Korea), the First Author of the trial, remarked, 'Among the two commonly used adjunct imaging devices in stent procedures, intravascular ultrasound (IVUS), which was developed first, has been considered the standard. Optical coherence tomography (OCT) had only been proven safe through small-scale studies.' Kang continued, 'Through this large-scale study, it was demonstrated that there was no significant difference in the safety profiles between the devices, with a major adverse clinical event rate of less than 3% annually. Duk-Woo Park, MD, PhD (Asan Medical Center, Korea), is presenting during a Hot Line Session at ESC Congress 2023, held in Amsterdam, Netherlands It is widely acknowledged that the utilization of IVI significantly enhances clinical outcomes, particularly in complex PCI cases. OCTIVUS Trial demonstrates that if you have some experience of IVUS or OCT, you can choose either one. Emphasized Duk-Woo Park, MD, PhD (Asan Medical Center, Korea), who presented the study's findings on Sunday, the 27th, during the 'Hotline' session, the flagship event of the European Society of Cardiology Annual Congress 2023, the preeminent cardiology conference held in Amsterdam, Netherlands. Furthermore, the study's outcomes were concurrently published in 'Circulation,' the official journal of the American Heart Association, reinforcing the trial's significance and reach within the global cardiology community. https://www.ahajournals.org/doi/full/10.1161/CIRCULATIONAHA.123.066429

October 27, 2023 3389

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TCTAP 2023

Physiologic Approach for Non-LM Bifurcation Lesions

Bon-Kwon Koo Seoul National University Hospital, Korea 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 4084

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TCTAP 2023

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

Samir R. Kapadia Cleveland Clinic, USA 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 2981

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TCTAP 2023

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

John Robert Laird, Jr. Adventist Heart & Vascular Institute, USA 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 2568