Transcatheter Aortic Valve Intervention Research Articles

The evolving landscape of transcatheter aortic valve intervention: a focus on native pure aortic regurgitation

The evolving landscape of transcatheter aortic valve intervention: a focus on native pure aortic regurgitation

Advances in Clinical Cardiology 2023: A Summary of Key Clinical Trials.

Over the course of 2023, numerous key clinical trials with valuable contributions to clinical cardiology were published or presented at major international conferences. This review seeks to summarise these trials and reflect on their clinical context. The authors collated and reviewed clinical trials presented at major cardiology conferences during 2023 including the American College of Cardiology (ACC), European Association for Percutaneous Cardiovascular Interventions (EuroPCR), European Society of Cardiology (ESC), Transcatheter Cardiovascular Therapeutics (TCT), American Heart Association (AHA), European Heart Rhythm Association (EHRA), Society for Cardiovascular Angiography and Interventions (SCAI), TVT-The Heart Summit (TVT) and Cardiovascular Research Technologies (CRT). Trials with a broad relevance to the cardiology community and those with potential to change current practice were included. A total of 80 key cardiology clinical trials were identified for inclusion. Key trials in acute coronary syndrome (ACS) and antiplatelet management such as HOST-IDEA, T-PASS and STOP-DAPT3 were included in addition to several pivotal interventional trials such as ORBITA 2, MULTISTARS-AMI, ILUMIEN-IV, OCTIVUS and OCTOBER. Additionally, several trials evaluated new stent design and technology such as BIOSTEMI, PARTHENOPE and TRANSFORM. Structural intervention trials included long-term data from PARTNER 3, new data on the durability of transcatheter aortic valve intervention (TAVI), in addition to major new trials regarding transcatheter tricuspid valve intervention from TRISCEND II. Heart failure (HF) and prevention covered several key studies including DAPA-MI, STEP-HF, ADVOR, DICTATE HF and CAMEO-DAPA. In cardiac devices and electrophysiology, several trial exploring novel ablation strategies in atrial fibrillation (AF) such as PULSED AF and ADVENT were presented with further data evaluating the efficacy of anticoagulation in subclinical AF in NOAH-AFNET 6, FRAIL AF and AZALEA-TIMI 71. This article presents a summary of key clinical cardiology trials published and presented during the past year and should be of interest to both practising clinicians and researchers.

Deep-learning survival analysis for patients with calcific aortic valve disease undergoing valve replacement

Calcification of the aortic valve (CAVDS) is a major cause of aortic stenosis (AS) leading to loss of valve function which requires the substitution by surgical aortic valve replacement (SAVR) or transcatheter aortic valve intervention (TAVI). These procedures are associated with high post-intervention mortality, then the corresponding risk assessment is relevant from a clinical standpoint. This study compares the traditional Cox Proportional Hazard (CPH) against Machine Learning (ML) based methods, such as Deep Learning Survival (DeepSurv) and Random Survival Forest (RSF), to identify variables able to estimate the risk of death one year after the intervention, in patients undergoing either to SAVR or TAVI. We found that with all three approaches the combination of six variables, named albumin, age, BMI, glucose, hypertension, and clonal hemopoiesis of indeterminate potential (CHIP), allows for predicting mortality with a c-index of approximately 80%\\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{mathrsfs} \\usepackage{upgreek} \\setlength{\\oddsidemargin}{-69pt} \\begin{document}$$80\\%$$\\end{document}. Importantly, we found that the ML models have a better prediction capability, making them as effective for statistical analysis in medicine as most state-of-the-art approaches, with the additional advantage that they may expose non-linear relationships. This study aims to improve the early identification of patients at higher risk of death, who could then benefit from a more appropriate therapeutic intervention.

Impact of left ventricular ejection fraction and aortic valve gradient on mortality following transcatheter aortic valve intervention

BackgroundData regarding the impact of reduced left ventricular ejection fraction (LVEF) and/or reduced mean aortic valve gradient (AVG) on outcomes following transcatheter aortic valve intervention (TAVI) have been conflicting. We sought to assess the relationship between LVEF, AVG, and 1-year mortality in patients undergoing TAVI. MethodsWe prospectively evaluated 298 consecutive adults undergoing TAVI from 2015 to 2018 at an academic tertiary medical center. Patients were categorized according to LVEF and mean AVG. The primary outcome of interest was all-cause mortality at 1 year. ResultsOf 298 adults undergoing TAVI, 66 (22.1%) had baseline LVEF ≤45% while 232 (77.9%) had baseline LVEF >45%; 173 (58.1%) had baseline AVG < 40mmHg while 125 (41.9%) had baseline AVG ≥ 40mmHg. Rates of 1-year all-cause mortality were significantly higher in patients with LVEF ≤45% (28.8% vs 12.1%, p = 0.001) and those with AVG < 40mmHg (19.7% vs 10.4%, p = 0.031) compared to those with LVEF >45% and AVG ≥ 40mmHg respectively. In multivariable analysis, higher AVG (per mmHg) (OR 0.97, 95% CI 0.94–0.99, p = 0.026) was noted to be independently associated with lower rates of 1-year mortality, while LVEF was not (OR 0.98, 95% CI 0.96–1.01). ConclusionsIn this prospective, contemporary registry of adults undergoing TAVI, while 1-year unadjusted mortality rates are significantly higher in patients with reduced LVEF and reduced AVG, risk-adjusted mortality at 1 year is only higher in those with reduced AVG – not in those with reduced LVEF.

European Society of Cardiology Quality indicators for the care and outcomes of adults undergoing transcatheter aortic valve implantation.

To develop a suite of quality indicators (QIs) for the evaluation of the care and outcomes for adults undergoing transcatheter aortic valve intervention (TAVI). We followed the European Society of Cardiology (ESC) methodology for the development of QIs. Key domains were identified by constructing a conceptual framework for the delivery of TAVI care. A list of candidate QIs were developed by conducting a systematic review of the literature. A modified Delphi method was then used to select the final set of QIs. Finally, we mapped the QIs to the EuroHeart Data Standards for TAVI to ascertain the extent to which the EuroHeart TAVI registry captures information to calculate the QIs. We formed an international group of experts in quality improvement and TAVI, including representatives from the European Association of Percutaneous Cardiovascular Interventions, the European Association of Cardiovascular Imaging and the Association of Cardiovascular Nursing & Allied Professions. In total, 27 QIs were selected across eight domains of TAVI care, comprising 22 main (81%) and five secondary (19%) QIs. Of these, 19/27 (70%) are now being utilised in the EuroHeart TAVI registry. We present the 2023 ESC QIs for TAVI, developed using a standard methodology and in collaboration with ESC Associations. The EuroHeart TAVI registry allows calculation of the majority of the QIs, which may be used for benchmarking care and quality improvement initiatives.

EE154 Cost-Effectiveness of Transcatheter Aortic Valve Intervention (TAVI) as Compared with Surgical Aortic Valve Intervention (SAVR) in Swedish Low Risk Aortic Stenosis Patients: Evidence Using Swedeheart Registry Data (2018-2020)

EE154 Cost-Effectiveness of Transcatheter Aortic Valve Intervention (TAVI) as Compared with Surgical Aortic Valve Intervention (SAVR) in Swedish Low Risk Aortic Stenosis Patients: Evidence Using Swedeheart Registry Data (2018-2020)

Distal aortic biomechanics after transcatheter versus surgical aortic valve replacement: a hypothesis generating study

BackgroundBiomechanical effects of transcatheter (TAVR) versus surgical (SAVR) aortic valve interventions on the distal aorta have not been studied. This study utilized global circumferential strain (GCS) to assess post-procedural biomechanics changes in the descending aorta after TAVR versus SAVR.MethodsPatients undergoing TAVR or SAVR for aortic stenosis were included. Transesophageal (TEE) and transthoracic (TTE) echocardiography short-axis images of the aorta were used to image the descending aorta immediately before and after interventions. Image analysis was performed with two-dimensional speckle tracking echocardiography and dedicated software. Delta GCS was calculated as: post-procedural GCS—pre-procedural GCS. Percentage delta GCS was calculated as: (delta GCS/pre-procedural GCS) × 100.ResultsEighty patients, 40 TAVR (median age 81 y/o, 40% female) and 40 SAVR (median 72 y/o, 30% female) were included. The post-procedure GCS was significantly higher than the pre-procedural GCS in the TAVR (median 10.7 [interquartile range IQR 4.5, 14.6] vs. 17.0 [IQR 6.1, 20.9], p = 0.009) but not in the SAVR group (4.4 [IQR 3.3, 5.3] vs. 4.7 [IQR 3.9, 5.6], p = 0.3). The delta GCS and the percentage delta GCS were both significantly higher in the TAVR versus SAVR group (2.8% [IQR 1.4, 6] vs. 0.15% [IQR − 0.6, 1.5], p < 0.001; and 28.8% [IQR 14.6%, 64.6%] vs. 4.4% [IQR − 10.6%, 5.6%], p = 0.006). Results were consistent after multivariable adjustment for key clinical and hemodynamic characteristics.ConclusionsAfter TAVR, there was a significantly larger increase in GCS in the distal aorta compared to SAVR. This may impact descending aortic remodeling and long-term risk of aortic events.

Abstract 18349: The Impact of Concomitant Mitral Regurgitation on Aortic Valve Intervention Outcomes in Paradoxical Low-Flow Low-Gradient Severe Aortic Stenosis

Background: Patients with paradoxical low flow low gradient severe aortic stenosis (LFLGAS) exhibit low transvalvular flow rates due to reduced stroke volumes, while maintaining preserved left ventricular ejection fraction (LVEF). The presence of mitral regurgitation (MR) adds complexity to this already challenging diagnosis, by further lowering flow rate. However, the impact of aortic valve intervention in this patient population remains uncertain. Methods: A total of 1178 patients were included from an institutional echo database with adjudicated aortic valve area (AVA &lt;1.0 cm2), transaortic gradients (mean gradient&lt; 40 mmHg) and low flow rate (Q ≤210 ml/sec), to confirm the diagnosis of LFLGAS and preserved LVEF (&gt;50%). Subgroups were formed based on the presence of severe MR and subsequent surgical and transcatheter aortic valve intervention (SAVR/TAVR). Patients who underwent mitral valve intervention were censored. All-cause mortality was assessed as the primary outcome. Results: Patients with severe MR had significantly lower flow rates compared to patients w/o severe MR (166.5 ± 26.3 vs 174.7 ± 25, p=0.006). During a median follow up of 1.3 years, 745 deaths (62.2%) were identified, with a cumulative incidence significantly lower in the intervention groups (Figure). After multivariate propensity adjustment for age, sex, aortic valve area and comorbidities, aortic valve intervention showed a significant reduction in mortality risk in both intervention groups, which was more pronounced in the severe MR group compared to patients w/o severe MR (AdjHR 0.334, p=0.015 vs 0.436, p&lt;0.001, p for interaction =0.24). Conclusions: In paradoxical low-flow low-gradient severe aortic stenosis, aortic valve intervention results in a survival benefit, especially among patients with concomitant severe MR. Our findings highlight the importance of recognizing severe MR as a flow-diverting lesion that can impact outcomes in LFLGAS.

Leaflet thrombosis in transcatheter aortic valve intervention: mechanisms, prevention, and treatment options.

Transcatheter aortic valve intervention (TAVR) has emerged as a promising alternative to surgical aortic valve replacement for patients with severe aortic stenosis. However, leaflet thrombosis has raised concerns about the long-term durability and outcomes of TAVR. This study aims to provide an overview of the mechanisms, prevention strategies, and treatment options for leaflet thrombosis in TAVR. Leaflet thrombosis refers to the formation of blood clots on bioprosthetic valve leaflets, leading to impaired leaflet mobility, early valve degeneration and dysfunction, and potential clinical implications. While the mechanisms underlying thrombus formation on valve leaflets are not fully understood, several factors, such as altered blood flow patterns within valve neosinuses, prothrombotic surfaces, and patient-related causes, have been implicated. Two distinct entities have been identified, namely, hypoattenuated leaflet thickening and restricted leaflet motion. Their occurrence appears dynamic over time and is related to the valve type. Imaging, including transesophageal echocardiography and multidetector computed tomography, plays a crucial role in the diagnosis and follow-up of leaflet thrombosis. Preventing leaflet thrombosis requires a comprehensive and tailored approach involving identifying high-risk patients, close monitoring, and antithrombotic therapy. Antithrombotic therapy with dual antiplatelet agents or anticoagulation is commonly employed in TAVR patients, although the optimal regimen is yet to be defined. Novel antithrombotic agents, such as direct oral anticoagulants, are being investigated for their efficacy and safety in preventing leaflet thrombosis. When leaflet thrombosis is detected, treatment options include intensified antithrombotic therapy, valve-in-valve intervention, or balloon valvuloplasty. The long-term outcomes and impact of leaflet thrombosis on valve durability and patient prognosis are areas of ongoing research. Leaflet thrombosis in TAVR is a considerable complication affecting valve function and patient outcomes. Understanding the mechanisms underlying thrombus formation and implementing appropriate prevention strategies are essential for mitigating this risk. Treatment options aim to restore leaflet mobility and optimize valve performance. Further research is needed to establish standardized protocols for antithrombotic therapy, identify high-risk patient populations, and determine the long-term consequences of leaflet thrombosis on TAVR outcomes.

Coronary artery disease and its management in TAVI

ObjectiveAortic stenosis and coronary artery disease (CAD) are frequently associated. The preprocedural evaluation and indications for treatment in patients undergoing transcatheter aortic valve intervention (TAVI) remain controversial.This study sought to 1) determine the prevalence and angiographic characteristics of CAD in TAVI candidates, along with revascularization patterns, and 2) to evaluate the impact of the presence and complexity of CAD, as well as angiography-guided percutaneous coronary intervention, on prognosis after TAVI. MethodsSingle-center retrospective study from a prospectively collected institutional registry that included all patients that underwent TAVI between 2009 and 2018 and pre TAVI coronary angiography (CA) in our institution in the context of pre-procedure work-up. A multivariate analysis was performed to determine the effect of CAD and PCI on 2-year mortality. ResultsA total of 379 patients were included: 55 patients (14.5%) presented with normal coronary arteries, 120 (31.6%) with non-obstructive CAD, and 204 (53.8%) with obstructive CAD (the mean SxS was 8.2). Ultimately, 110 patients (29%) underwent PCI. Two-year survival after TAVI was decreased in patients with complex coronary lesions (SS > 22), while it was not affected by the overall presence of non-obstructive CAD, obstructive CAD, residual SxS, or pre-TAVI PCI of angiographically significant lesions (OR 0.631, 95%CI 0.192-1.406). ConclusionIn our population, the overall presence and management of obstructive CAD did not appear to impact mortality at 2 years after TAVI. Survival was decreased in patients with baseline complex coronary anatomies.

TAVI after More Than 20 Years.

It has been more than 20 years since the first in man transcatheter aortic valve intervention (TAVI), and during this period we have witnessed an impressive evolution of this technique, with an extension of its use from non-operable patients to high-, intermediate- and even low-risk patients with aortic stenosis, and with a decrease in the incidence of complications. In this review, we discuss the evaluation of patients before TAVI, the procedure and the changes it has seen over time, and we present the current main complications and challenges of TAVI.

Invasive Functional Assessment of Coronary Artery Disease in Patients with Severe Aortic Stenosis in the TAVI Era.

Coronary artery disease (CAD) is a common finding in patients suffering from aortic valve stenosis (AS), with a prevalence of over 50% in patients 70 years of age or older. Transcatheter aortic valve intervention (TAVI) is the standard treatment option for patients with severe AS and at least 75 years of age. Current guidelines recommend percutaneous coronary intervention (PCI) in patients planned for TAVI with stenoses of >70% in the proximal segments of non-left main coronary arteries and in >50% of left main stenoses. While the guidelines on myocardial revascularization clearly recommend functional assessment of coronary artery stenoses of less than 90% in the absence of non-invasive ischemia testing, a statement regarding invasive functional testing in AS patients with concomitant CAD is lacking in the recently published guideline on the management of valvular heart disease. This review aims to provide an overview of the hemodynamic background in AS patients, discusses and summarizes the current evidence of invasive functional testing in patients with severe AS, and gives a future perspective on the ongoing trials on that topic.

Changing haemodynamic status of patients referred for transcatheter aortic valve intervention during the COVID-19 pandemic.

Delays in the diagnosis and referral of aortic stenosis (AS) during the coronavirus disease 2019 (COVID-19) pandemic may have affected the haemodynamic status of AS patients. We aimed to compare clinical and haemodynamic characteristics of severe AS patients referred for transcatheter aortic valve implantation (TAVI) or balloon aortic valvuloplasty (BAV) before the pandemic versus two subsequent periods. This study compared three 1‑year historical cohorts: apre-COVID-19 group (PCOV), a1st-year COVID-19 group (COV-Y1) and a2nd-year COVID-19 group (COV-Y2). The main parameters were baseline New York Heart Association (NYHA) functional class, left ventricular ejection fraction (LVEF) and left ventricular end-diastolic pressure (LVEDP). Demographics, procedural characteristics and 30-day clinical outcomes were assessed. The transition time between heart team decision and TAVI was examined. Pairwise group comparisons were performed (PCOV vs COV-1Y and COV-1Y vs COV-2Y). Atotal of 720patients were included with 266, 249 and 205patients in the PCOV, COV-Y1 and COV-Y2groups, respectively. BAV was performed in 28patients (4%). NYHA class did not differ across the cohorts. Compared to PCOV, LVEF was slightly lower in COV-Y1 (58% (49-60%) vs 57% (45-60%), p = 0.03); no difference was observed when comparing COV-Y1 and COV-Y2. LVEDP was higher in COV-Y1 than in PCOV (20 mm Hg (16-26 mm Hg) vs 17 mm Hg (13-24 mm Hg), p = 0.01). No difference was found when comparing LVEDP between COV-Y1 and COV-Y2. Thirty-day mortality did not differ between groups. Transition time was reduced in the COVID era. Duration of hospital stay declined over the study period. Patients undergoing TAVI during the COVID-19 pandemic had more advanced AS illustrated by lower LVEF and higher LVEDP, but there were no differences in clinical outcome. The TAVI pathway became more efficient.

An Updated Meta-Analysis on Cerebral Embolic Protection in Patients Undergoing Transcatheter Aortic Valve Intervention Stratified by Baseline Surgical Risk and Device Type

BackgroundTranscatheter aortic valve intervention (TAVI) can lead to the embolization of debris. Capturing the debris by cerebral embolic protection (CEP) devices may reduce the risk of stroke. New evidence has allowed us to examine the effects of CEP in patients undergoing TAVI. We aimed to assess the effects of CEP overall and stratified by the device used (SENTINEL or TriGuard) and the surgical risk of the patients. MethodsWe selected randomized controlled trials using electronic databases through September 17, 2022. We estimated random-effects risk ratios (RR) with (95% confidence interval) and calculated absolute risk differences at 30 days across baseline surgical risks derived from the TAVI trials for any stroke (disabling and nondisabling) and all-cause mortality. ResultsAmong 6 trials (n = 3921), CEP vs. control did not reduce any stroke [RR: 0.95 (0.50-1.81)], disabling [RR: 0.75 (0.18-3.16)] or nondisabling [RR: 0.99 (0.65-1.49)] strokes, or all-cause mortality [RR: 1.23 (0.55-2.77)]. However, when analyzed by device, SENTINEL reduced disabling stroke [RR: 0.46 (0.22-0.95)], translating into 6 fewer per 1000 in high-risk, 3 fewer per 1000 in intermediate-risk, and 1 fewer per 1000 in low surgical-risk patients. CEP vs. control did not reduce the risk of any bleeding [RR: 1.03 (0.44-2.40)], major vascular complications [RR: 1.41 (0.57-3.48)], or acute kidney injury [RR: 1.36 (0.57-3.28)]. ConclusionsThis updated meta-analysis showed that SENTINEL CEP might reduce disabling stroke in patients undergoing TAVI. Patients with high and intermediate surgical risks were most likely to derive benefits.

The Use of Three-Dimensional Printing in Cardiac Structural Disease: A Review.

Three-dimensional printing (3DP), or additive fabrication, is a process in which a physical 3D model is created using a multitude of 2-dimensional images. This process has been applied to numerous surgical subspecialties with growing interest for the use of 3DP in adult structural heart disease. This scoping review evaluates the use of 3DP in transcatheter and surgical aortic and mitral valve interventions as well as left atrial appendage occlusion in terms of its practical and clinical application. Articles were identified through PubMed and Embase using MeSH search terms as well as independent searches. A total of 645 articles were screened, and 37 were retained for qualitative analysis. Operative planning was coded in 100% of articles, complication prevention in 43%, medical education in 5.4%, patient education in 0%, and simulation in 5.4%. The main uses of 3DP in acquired structural heart disease are centered around operative planning and complication prevention, with moderate use regarding surgical simulation and infrequent use regarding medical and/or patient education. Although patient anatomy varies greatly, deploying 3DP as a large-scale tool remains a possibility. The more 3D models are made, the more can be learned about demographic subsets of patient populations. Due to the lack of standard operating procedures for the creation of 3DP models, the cost-effectiveness of these models is hard to determine and likely center specific. More research into this facet could inform centers that wish to implement this tool.

Transcatheter Aortic Valve Implantation Two Decades of Evolution - TAVI From Current Perspective

Background: In the treatment of valvular heart diseases, transcatheter therapies have changed the rules of the game, especially in the case of aortic stenosis and mitral regurgitation. Since the first in man transcatheter aortic valve intervention (TAVI) performed by Dr. Alain Cribier in 2002 in a non-operable aortic stenosis (AS) patient, TAVI has changed the lives of so many patients for whom medical treatment was, up to then, the only option. Objective: This article outlines patient selection and pre-procedure evaluation, current perspectives, recent advances, current and future devices, current guidelines informing the use of TAVI, expanding indications for TAVI, ongoing challenges and the future of TAVI. Methods: The use of these percutaneous techniques has also increased significantly in the past few years with its first application in 2002, transcatheter aortic valve implantation (TAVI) has revolutionized the management of aortic stenosis and has become the standard of care for patients with AS at prohibitively high surgical risks, as well as a preferred treatment for elderly patients with intermediate and high-risk AS. Results: Since the first pioneering procedure was performed 22 years ago, transcatheter aortic valve implantation (TAVI) has evolved into a routine procedure increasingly performed under conscious sedation via transfemoral access. On a global market worth $2 billion per year, over 300 000 patients have received a transcatheter aortic valve, demonstrating its clinical and market impact. TAVI may be used in lower risk, younger, asymptomatic populations with ongoing studies using an expanding portfolio of devices. Also, for patients deemed unsuitable for cardiac surgery, mitral transcatheter therapies represent the treatment of choice. Percutaneous repair techniques have had the most clinical experience to date. Conclusion: During this 20-year period, the increased knowledge on pre-procedural planning, the important technological improvements in transcatheter valves, the increased experience and the numerous studies that have been carried out have permitted an expansion of the indications for TAVI, from inoperable patients to high- and intermediate-risk patients. This article outlines patient selection and pre-procedure evaluation, current perspectives, recent advances, current and future devices, current guidelines informing the use of TAVI, expanding indications for TAVI, ongoing challenges and the future of TAVI.

1044 CHARACTERISTIC AND OUTCOME IN PATIENTS WITH LOW FLOW, LOW GRADIENT AORTIC STENOSIS

Abstract Aim The aim of this study was to assess the prevalence and outcome in patients with severe low flow, low gradient aortic stenosis (LFLG-AS) undergoing transcatheter aortic valve intervention (TAVI). Methods Patients with LFLG AS undergoing TAVI from 2013 to 2022 were prospectively collected. Clinical, imaging data and procedural parameters were collected. LFLG-AS was defined as indexed aortic valve area (iAVA) ≤0.6 cm2/m2, mean transaortic gradient &amp;lt;40 mmHg and stroke volume index &amp;lt;36 ml/m2. Overall population was classified in due subgroups: classical LFLG AS if left ventricular ejection fraction (LVEF) was &amp;lt;50%, and paradoxical in patients with preserved LVEF. The major comorbidities and primary outcome defined as a composite of all-cause mortality and rehospitalization for worsening heart failure (HF) up to 1 year in the different subtypes of severe LFLG AS undergoing TAVI were evaluated. Results The study included 268 patients [81±6 years; 142 (53%) females]; of these, 155 patients (58%) had paradoxical LFLG AS and 113 patients (42%) had LFLG AS with low LVEF. Regarding echocardiography parameters, in the overall population the mean transaortic gradient was 31±6 mmHg, the mean iAVA 0.38±0.08 cm/m2, and the median LVEF 50% (IQR 38-55). Compared with paradoxical LFLG AS, the patients with classical form were characterized by a lower percentage of women (43% vs. 60% p 0.07), worse renal function (46% vs. 30%, p 0.012), and a significantly higher number of cardiovascular disease as coronary artery disease (52% vs. 29%, p &amp;lt;0.001) and atrial fibrillation (37% vs. 23%, p 0.018), resulting in higher Society of Thoracic Surgeons scores [7,34% (IQR: 4.96 to 13,25) versus 5,36% (IQR: 3,22 to 11); p value 0.037]. Higher percentage of patients of New York Heart Association functional class III or IV (61% vs. 27%; p 0.037) was observed in classical LFLG AS. At one-year follow-up, the composite outcome was reported in 49 patients (18%), 21 patients (13%) had paradoxical LFLG AS and 28 patients (24%) had classical form. Kaplan-Meier survival free from the composite outcome was significantly lower in patients with classical LFLG AS compared to those paradoxical LFLG AS (Log-Rank 0,022, Figure 1). Conclusion LFLG AS is a complex population with significant incidence of adverse event at one years. Patients with classical LFLG AS have higher number of risk factor and cardiovascular disease and lower survival compared paradoxical form. Figure 1

PP09 Use Of Real-World Evidence For Managing Health Technologies Throughout The Life Cycle Of Transcatheter Aortic Valve Interventions

IntroductionA Cardiology Evaluation Unit was established in 2004 within Québec’s Institut national d’excellence en santé et en services sociaux (INESSS) with a novel mandate to collect real-world evidence (RWE) to complement literature-based health technology assessment. In 2010 following publication of the seminal PARTNER trial, INESSS was mandated by the health ministry to review the evidence on transcatheter aortic valve intervention (TAVI) for patients with aortic stenosis. Herein we show how RWE was used to evaluate health system performance throughout the technology’s life cycle and inform organizational and clinical decisions.MethodsVarious products were diffused by INESSS over the years: a guidance (2012), an updated literature review (2017) and provincial standards (2017), in parallel with RWE reports covering TAVI use from 2013-2015, from 2013-2018, and a 2021 RWE report combined with administrative data covering transcatheter and surgical treatment of aortic stenosis from 2013-2019.ResultsBased on the guidance’s review of evidence, TAVI was initially recommended for patients considered at too high risk for the surgical approach, under the condition of continued evidence generation to address uncertainty. The subsequent literature review update highlighted that the indication for TAVI had been extended to patients at moderate surgical risk. INESSS produced standards in collaboration with clinical experts to optimize and harmonize the use of TAVI in designated centers. Evaluation of structures, processes and outcomes by INESSS continued until 2019, showing a continuous increase in the use of TAVI, improved short-term survival, and careful patient selection via a multidisciplinary process. RWE also highlighted the impact of TAVI on the overall organization of care for patients with aortic stenosis, as selection criteria further expanded to patients at lower surgical risk, raising important issues regarding patient selection processes, wait times, and longer-term outcomes.ConclusionsTAVI clinical practice is constantly evolving and leads to changes in the management of aortic stenosis. RWE provided essential organizational and clinical input to inform clinical guidance and decision-making by Québec policy-makers, clinicians and patients.

Abstract 13551: Non-Invasive Assessment of Systemic Microvascular Function in Patients With Severe Aortic Stenosis Pre- and Post- Transcatheter Aortic Valve Intervention

Background: Aortic stenosis (AS) is associated with pathophysiological changes in both left ventricular and coronary microvascular structure and function. The treatment of AS with transcatheter aortic valve replacement (TAVR) has been associated with improvements in invasive indices of coronary microvascular function. This study sought to address whether systemic microvascular dysfunction was present in patients with AS and if microvascular function was altered by treatment of aortic stenosis with TAVR. The conjunctival microcirculation was used as the site for the non-invasive assessment of systemic microvascular function. Methods: Patients undergoing TAVR for the treatment of severe AS were compared to a cohort of age- and sex-matched controls without valvular heart disease. Conjunctival vascular imaging was performed in all subjects using a previously validated combination of a smartphone and slit-lamp biomicroscope. This technique allowed measurement of vessel diameter and other indices of microvascular function by tracking erythrocyte motion. Conjunctival hemodynamics were compared pre- and post-TAVR, in addition to between the severe AS and control cohorts. Results: A total of 165 patients were included (90 severe AS and 75 controls). Baseline characteristics were well matched between groups. In comparison to the control cohort, arteriole axial (Va) and cross-sectional velocity (Vcs) were significantly lower in females with AS (Va severe AS 0.53 ± 0.11mm/s vs control 0.59 ± 0.12mm/s, p=0.047; Vcs severe AS 0.38 ± 0.07mm/s vs control 0.41 ± 0.08mm/s, p=0.043), but not in males (Va severe AS 0.61 ± 0.11mm/s vs control 0.58 ± 0.10mm/s, p=0.19; Vcs severe AS 0.43 ± 0.08mm/s vs control 0.41 ± 0.07mm/s, p=0.20). Arteriole Va and Vcs significantly increased following TAVR in females (Va Pre-TAVR 0.52 ± 0.16mm/s vs post-TAVR 0.59 ± 0.15mm/s, p&lt;0.001; Vcs Pre-TAVR 0.37 ± 0.11mm/s vs post-TAVR 0.42 ± 0.11mm/s, p&lt;0.001). Conclusion: This study highlights sex-specific differences in conjunctival microvascular function in patients with severe AS. In this study TAVR resulted in significant improvements in conjunctival arteriolar V a and V cs . These findings are consistent with severe AS being a reversible cause of systemic microvascular dysfunction.

Segmentation of human aorta using 3D nnU-net-oriented deep learning.

Computed tomography angiography (CTA) has become the main imaging technique for cardiovascular diseases. Before performing the transcatheter aortic valve intervention operation, segmenting images of the aortic sinus and nearby cardiovascular tissue from enhanced images of the human heart is essential for auxiliary diagnosis and guiding doctors to make treatment plans. This paper proposes a nnU-Net (no-new-Net) framework based on deep learning (DL) methods to segment the aorta and the heart tissue near the aortic valve in cardiac CTA images, and verifies its accuracy and effectiveness. A total of 130 sets of cardiac CTA image data (88 training sets, 22 validation sets, and 20 test sets) of different subjects have been used for the study. The advantage of the nnU-Net model is that it can automatically perform preprocessing and data augmentation according to the input image data, can dynamically adjust the network structure and parameter configuration, and has a high model generalization ability. Experimental results show that the DL method based on nnU-Net can accurately and effectively complete the segmentation task of cardiac aorta and cardiac tissue near the root on the cardiac CTA dataset, and achieves an average Dice similarity coefficient of 0.9698 ± 0.0081. The actual inference segmentation effect basically meets the preoperative needs of the clinic. Using the DL method based on the nnU-Net model solves the problems of low accuracy in threshold segmentation, bad segmentation of organs with fuzzy edges, and poor adaptability to different patients' cardiac CTA images. nnU-Net will become an excellent DL technology in cardiac CTA image segmentation tasks.