Conferences

TCTAP

SEOUL VALVES

LEFT MAIN SUMMIT

ACT Program

Search the news

Total: 255

TCTAP 2024

TAVR-in-TAVR: The NEXT Challenging Issue in Lifetime TAVR Management

Philippe Garot, MD Institut Cardiovasculaire Paris-Sud, France Compared to surgical aortic valve replacement (SAVR), there is an increasing use of transcatheter aortic valve replacement (TAVR) in patients over 80 years old, as well as in those aged 65-80 years in western countries. In patients with a remaining life-expectancy of over 10 years, a considerable number of transcatheter heart valves (THVs) are expected to fail, requiring repeat intervention. According to a multicenter registry, surgical explantation after TAVR failure was associated with an overall mortality of almost 15% at 30 days and 30% at 1 year follow-up. Contrastingly, redo-TAVR is relatively safe and effective. Underexpansion of THVs may lead to hypoattenuated leaflet thickening (HALT) and early dysfunction with elevated gradients. In these patients, a staged post-dilation of the THVs may improve hemodynamics and delay a redo-TAVR procedure. Coronary access may be impaired after a redo-TAVR procedure. Factors impacting coronary access may be anatomical, or related to the device and the procedure. The design of the index TAVR implant is associated with a different risk of sinus sequestration and coronary obstruction. The risk of sinus sequestration increases up to 91% in balloon-expandable valve (BEV)-in-self-expandable valve (SEV) and 75% in SEV-in-SEV, and in these cases, leaflet interventions should be considered as a prerequisite for redo-TAVR (Figure 1 ). The optimal THV design and implantation technique for redo-TAVR are poorly understood. In the case of redo-TAVR, the leaflets of the failed THV may create a “tube graft,” where the index THV leaflets can be jailed between the two THV frames. This can create a neoskirt of tissues from the failed THV inflow to the top of the jailed leaflet, which may limit subsequent coronary access and flow. The higher the second THV, the taller the neoskirt, with a higher risk of sinus sequestration. The position of both the index and the second THV are crucial in avoiding sinus sequestration. In some patients, the second implant must be lower to avoid a tall neoskirt, causing a significant leaflet overhang in return. The width of the sinuses of Valsalva is a key for a reasonable valve-to-coronary (VTC) distance, which may be compromised by THV flaring, second implant depth and valve canting. The risk of coronary obstruction after redo-TAVR is strongly related to the index TAVR design, the implant depth of the index THV and commissural alignment of both the index and redo-THV, which can help avoiding coronary obstruction and facilitate leaflet interventions. Also, the index failed THV may expand after redo-TAVR, and this should be considered when determining the VTC distance. Figure 1. Different THV-in-THV combinations and the neoskirt heights TCTAP Workshops TAVR: Key Issues in 2024 Thursday, April 25, 10:30 AM ~ 11:25 AM Presentation Room 1, Level 1 Check The Session

April 25, 2024 923

COMPLEX PCI 2023

When to Go Retrograde?

The groundbreaking work of Maoto Habara, MD (Toyohashi Heart Center, Japan), took center stage as he shared insights on the optimal timing and considerations for a retrograde approach in Chronic Total Occlusion (CTO) Percutaneous Coronary Intervention (PCI). In the dynamic realm of CTO PCI, the pivotal question of when to adopt a retrograde approach has become a focal point. Over the years, the success rate of CTO PCI has experienced a remarkable surge from 50-70% to a robust 85-90%, underscoring the evolution of techniques and technologies within this specialized field. Key contributors to this significant improvement include the refinement of equipment. Innovative techniques, such as parallel wire approaches, IVUS-guided rewiring, ADR, and retrograde methodologies, have become instrumental in achieving higher success rates. A thorough understanding of CTO pathology and the nuanced mechanics of guidewire manipulation, involving factors like deflection, and whipping motion, has proven pivotal in this advancement. Recent registry data, incorporating insights from Asian CTO experts along with data from Europe and the US, consistently show procedural success rates exceeding 85%. The retrograde approach, employed in approximately 20-30% of cases, emerges as a critical component in contemporary CTO PCI practices. Its efficacy becomes particularly evident in complex CTO scenarios where the antegrade approach encounters challenges and in cases with compromised distal vessel quality or notable side branches at the distal cap. Notably, the retrograde approach minimizes contrast consumption in patients with chronic kidney disease, adding another layer to its benefits. Critical considerations in this decision-making process encompass dual injection, thorough angiogram analysis, and confirmatory IVUS checks in the presence of ambiguity at the proximal cap or poor distal vessel quality. The angle of the retrograde channel, vessel size, and other factors play a crucial role in the assessment, guiding the decision-making process. Real-world cases vividly illustrate the retrograde approach's efficacy in scenarios like proximal cap ambiguity, distal exit uncertainty, and antegrade penetration challenges. Guideline recommendations advocate restricting antegrade guidewire manipulation to a 20-minute window due to associated risks, underscoring the importance of a thoughtful and timely approach. In conclusion, the decision of when to opt for the retrograde approach hinges on variables such as proximal cap ambiguity, distal vessel quality, and the success of antegrade wiring within a 20-minute timeframe. This nuanced decision-making process, coupled with alternatives like ADR, parallel wire, or IVUS-guided rewiring, serves as a cornerstone for optimizing success in CTO PCI procedures.

Feburary 2, 2024 3730

COMPLEX PCI 2023

Novel Antegrade Wiring for CTO PCI: Concept of OPV & PPV and Its Clinical Application

Kenya Nasu, MD (Mie Heart Center, Japan), introduced the groundbreaking "Penetration Plane Method," designed to simplify the intricate task of wire manipulation in CTO interventions. By emphasizing the optimal utilization of this method and focusing on the distal landing zone, he highlighted its ability to offer a more predictable and controllable motion for guidewires. The Penetration Plane Method operates with the assistance of the Penetration Plane View (PPV), providing a perspective where the vessel appears straight, ensuring a streamlined guidewire trajectory. Derived from a direction that flattens the plane, this viewpoint ensures the maintenance of a straight guidewire appearance. Complementing this, the Objective Perpendicular View (OPV) offersa perpendicular perspective, forming the foundational approach of the Penetration Plane Method. Ensuring precision in the approach, an accurate perpendicular view measurement was highlighted, achieved through a vector projection method. He showcased the method's effectiveness by utilizing two random projections of coronary angiograms to reconstruct the three-dimensional structure of coronary arteries. To further enhance accuracy, he discussed the development of specialized software capable of selecting the optimal angle, identifying the best vector, and calculating the perpendicular, providing a clear representation of the vessel vector on the screen. Additionally, he introduced the ongoing development of ECG-synchronized fluoroscopy, addressing limitations associated with cardiac motion during the Penetration Plane Method. This technology aims to offer nearly stationary coronary angiograms at specific points in the cardiac cycle, ensuring optimal visualization. He demonstrated the entire process through a practical example during the session, emphasizing its simplicity and effectiveness. The integration of navigation software and mapping was underscored, promising precise guidance for guidewire manipulation. Concluding the lecture, he raised expectations for the future of guidewire manipulation, hinting at evolving technologies and methodologies. He emphasized the need for adaptation to advanced devices, including the integration of plasma-mediated ablation systems for CTO procedures. His presentation marked a significant step towards reshaping the landscape of coronary interventions, offering new hope and possibilities for the field.

Feburary 2, 2024 3029

COMPLEX PCI 2023

Be Provisional!
Optimal Provisional Strategy for LM PCI

Hyeon-Cheol Gwon, MD, PhD (Samsung Medical Center, Korea), began his presentation by examining the prevalence of the provisional approach in LM bifurcation, referencing the IRIS-MAIN and COBIS II registries. These registries revealed a high prevalence of the provisional approach, with respective rates of 91.9% and 78.8%, indicating its widespread acceptance in the medical community. He further expanded on this by referencing various trials, including EBC Main and DK-CRUSH V. These trials compared the provisional approach with systematic two-stent strategies, highlighting that the simpler provisional approach yields outcomes comparable to the more complex two-stent strategies. Building on this foundation, he emphasized that stepwise layered provisional stenting is recommended as the preferred strategy for treating left main coronary bifurcation lesions. This approach, which balances efficacy with minimal invasiveness, is crucial for optimizing patient outcomes. A key aspect of his presentation was the emphasis on the proximal optimization technique (POT) as an essential element in stenting optimization. He stressed that POT is a critical step in ensuring the stent is optimally placed and expandedto match the vessel's anatomy, which can significantly enhance the long-term success of the procedure. Another important point he made was regarding the treatment of the Left Circumflex (LCX) ostium. He noted that opening the LCX ostium does not show superior results compared to a simple crossover technique in a one-stent strategy, particularly in terms of long-term outcomes. This finding suggests that in many cases, a more conservative approach to LCX treatment might be preferable, avoiding unnecessary complexity in the stenting procedure. He concluded that bifurcation lesions may be the only type of lesion that shows a better outcome when treated conservatively. This insight underscores the importance of a measured and thoughtful approach in interventional cardiology, particularly in the context of complex procedures like left main coronary bifurcation stenting. Overall, his lecture provided a comprehensive view of the current strategies and data in treating left main coronary bifurcation lesions. His emphasis on a conservative, strategic approach, supported by substantial clinical data, presents a compelling argument for the provisional approach in interventional cardiology. These insights are poised to influence treatment strategies significantly, potentially leading to improved patient outcomes in complex coronary interventions.

January 26, 2024 2482

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 2417

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 2436

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 1875

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 1, 2023 3248

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 3138

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 2243