An interactive, online decision aid assessing patient goals and preferences for treatment of aortic stenosis to support physician-led shared decision-making: Early feasibility pilot study.

BACKGROUND: Guidelines recommend shared decision making when choosing treatment for severe aortic stenosis but implementation has lagged. We assessed the feasibility and impact of a novel decision aid for severe aortic stenosis at point-of-care. METHODS: This prospective multi-site pilot cohort study included adults with severe aortic stenosis and their clinicians. Patients were referred by their heart team when scheduled to discuss treatment options. Outcomes included shared decision-making processes, communication quality, decision-making confidence, decisional conflict, knowledge, stage of decision making, decision quality, and perceptions of the tool. Patients were assessed at baseline (T0), after using the intervention (T1), and after the clinical encounter (T2); clinicians were assessed at T2. Before the encounter, patients reviewed the intervention, Aortic Valve Improved Treatment Approaches (AVITA), an interactive, online decision aid. AVITA presents options, frames decisions, clarifies patient goals and values, and generates a summary to use with clinicians during the encounter. RESULTS: 30 patients (9 women [30.0%]; mean [SD] age 70.4 years [11.0]) and 14 clinicians (4 women [28.6%], 7 cardiothoracic surgeons [50%]) comprised 28 clinical encounters Most patients [85.7%] and clinicians [84.6%] endorsed AVITA. Patients reported AVITA easy to use [89.3%] and helped them choose treatment [95.5%]. Clinicians reported the AVITA summary helped them understand their patients' values [80.8%] and make values-aligned recommendations [61.5%]. Patient knowledge significantly improved at T1 and T2 (p = 0.004). Decisional conflict, decision-making stage, and decision quality improved at T2 (p = 0.0001, 0.0005, and 0.083, respectively). Most patients [60%] changed treatment preference between T0 and T2. Initial treatment preferences were associated with low knowledge, high decisional conflict, and poor decision quality; final preferences were associated with high knowledge, low conflict, and high quality. CONCLUSIONS: AVITA was endorsed by patients and clinicians, easy to use, improved shared decision-making quality and helped patients and clinicians arrive at a treatment that reflected patients' values. TRIAL REGISTRATION: Trial ID: NCT04755426, Clinicaltrials.gov/ct2/show/NCT04755426.

Recent updates on asymptomatic and symptomatic aortic valve stenosis its diagnosis, pathogenesis, management and future perspectives.

Aortic stenosis (AS) is very common in mid-aged and elderly patients, and it has been reported to have a negative impact on both short and long-term survival with a high mortality rate. The current study identified methods of diagnosis, incidence, and causes of AS, pathogenesis, intervention and management and future perspectives of Asymptomatic and Symptomatic Aortic stenosis. A systematic literature search was conducted using PubMed, Scopus and CINAHL, using the Mesh terms and key words "Aortic stenosis", "diagnostic criteria", "pathogenesis", "incidence and causes of AS" and" intervention and management strategies". Studies were retained for review after meeting strict inclusion criteria that included studies evaluating Asymptomatic and Symptomatic AS. Studies were excluded if duplicate publication, overlap of patients, subgroup studies of a main study, lack of data on AS severity, case reports and letters to editors. Forty-five articles were selected for inclusion. Incidence of AS across the studies ranged from 3 % to 7 %. Many factors have been associated with incidence and increased risk of AS, highest incidence of AS was described after aortic valve calcification, rheumatic heart disease, degenerative aortic valve disease, bicuspid aortic valve and other factors. AS is common and can be predicted by aortic root calcification volume, rheumatic heart disease, degenerative aortic valve disease, bicuspid aortic valve. Intervention and management for AS patients is a complex decision that takes into consideration multiple factors. On the other hand, there is not enough progress in preventive pharmacotherapy to slow the progression of AS.

Elevated Lp(a): Guidance for Identifying and Managing Patients.

Lipoprotein(a) (Lp(a)) is a unique low-density lipoprotein-like lipoprotein that is considered an independent and causal risk factor for atherosclerotic cardiovascular disease (ASCVD) and calcific aortic valve stenosis. The Lp(a) molecule also contains apolipoprotein A and apolipoprotein B, which collectively promote atherosclerosis, thrombosis, and inflammation. Lp(a) is highly genetic and minimally responsive to nonpharmacological measures. Lp(a) serum levels ≥125 nmol/L are associated with increased ASCVD risk, but this threshold has not been accepted universally. Elevated Lp(a) is the most common genetic dyslipidemia affecting approximately 20% of the general population. Certain currently available lipid-lowering drugs, including the proprotein convertase subtilisin/kexin type 9 therapies, produce moderate reductions in Lp(a); however, none are indicated for the treatment of elevated Lp(a). There are currently four investigational RNA-based therapeutic agents that reduce Lp(a) by 70% to 100%. Two of these agents are being evaluated for ASCVD risk reduction in adequately powered outcomes trials, with results expected in 2 to 3 years. Until such therapies become available and demonstrate favorable clinical outcomes, strategies for elevated Lp(a) primarily involve early and intensive ASCVD risk factor management.

[Update Valvular Heart Disease: Heart Team Decision-Making Based on Patient Examples]. / Update valvuläre Herzkrankheiten: Entscheidungen im interdisziplinären Herzteam anhand von Beispielen.

INTRODUCTION: In Europe, mitral regurgitation and aortic stenosis are the most common valve lesions requiring interventions. In advanced stages, these valve pathologies affect patients' quality of life and prognosis. The prevalence of mitral regurgitation and aortic stenosis is increasing with age. In view of an aging population and the comorbidities associated with age, these valve defects represent an increasing challenge to health care providers. Nowadays, surgical as well as catheter-based treatment options are available to treat affected patients. Therapeutic strategies suitable to the individual patient should be discussed in interdisciplinary heart teams. The aim of the present article is to give an overview of possible guideline-conform heart team decisions based on patient examples.

Comparison of different percutaneous revascularisation timing strategies in patients undergoing transcatheter aortic valve implantation.

BACKGROUND: The optimal timing to perform percutaneous coronary interventions (PCI) in transcatheter aortic valve implantation (TAVI) patients remains unknown. AIMS: We sought to compare different PCI timing strategies in TAVI patients. METHODS: The REVASC-TAVI registry is an international registry including patients undergoing TAVI with significant, stable coronary artery disease (CAD) at preprocedural workup. In this analysis, patients scheduled to undergo PCI before, after or concomitantly with TAVI were included. The main endpoints were all-cause death and a composite of all-cause death, stroke, myocardial infarction (MI) or rehospitalisation for congestive heart failure (CHF) at 2 years. Outcomes were adjusted using the inverse probability treatment weighting (IPTW) method. RESULTS: A total of 1,603 patients were included. PCI was performed before, after or concomitantly with TAVI in 65.6% (n=1,052), 9.8% (n=157) or 24.6% (n=394), respectively. At 2 years, all-cause death was significantly lower in patients undergoing PCI after TAVI as compared with PCI before or concomitantly with TAVI (6.8% vs 20.1% vs 20.6%; p<0.001). Likewise, the composite endpoint was significantly lower in patients undergoing PCI after TAVI as compared with PCI before or concomitantly with TAVI (17.4% vs 30.4% vs 30.0%; p=0.003). Results were confirmed at landmark analyses considering events from 0 to 30 days and from 31 to 720 days. CONCLUSIONS: In patients with severe aortic stenosis and stable coronary artery disease scheduled for TAVI, performance of PCI after TAVI seems to be associated with improved 2-year clinical outcomes compared with other revascularisation timing strategies. These results need to be confirmed in randomised clinical trials.

The common pathobiology between coronary artery disease and calcific aortic stenosis: Evidence and clinical implications.

Calcific aortic valve stenosis (CAS), the most prevalent valvular disease worldwide, has been demonstrated to frequently occur in conjunction with coronary artery disease (CAD), the third leading cause of death worldwide. Atherosclerosis has been proven to be the main mechanism involved in CAS and CAD. Evidence also exists that obesity, diabetes, and metabolic syndrome (among others), along with specific genes involved in lipid metabolism, are important risk factors for CAS and CAD, leading to common pathological processes of atherosclerosis in both diseases. Therefore, it has been suggested that CAS could also be used as a marker of CAD. An understanding of the commonalities between the two conditions may improve therapeutic strategies for treating both CAD and CAS. This review explores the common pathogenesis and disparities between CAS and CAD, alongside their etiology. It also discusses clinical implications and provides evidence-based recommendations for the clinical management of both diseases.

Pathophysiology, emerging techniques for the assessment and novel treatment of aortic stenosis.

Our perspectives on aortic stenosis (AS) are changing. Evolving from the traditional thought of a passive degenerative disease, developing a greater understanding of the condition's mechanistic underpinning has shifted the paradigm to an active disease process. This advancement from the 'wear and tear' model is a result of the growing economic and health burden of AS, particularly within industrialised countries, prompting further research. The pathophysiology of calcific AS (CAS) is complex, yet can be characterised similarly to that of atherosclerosis. Progressive remodelling involves lipid-protein complexes, with lipoprotein(a) being of particular interest for diagnostics and potential future treatment options.There is an unmet clinical need for asymptomatic patient management; no pharmacotherapies are proven to slow progression and intervention timing varies. Novel approaches are developing to address this through: (1) screening with circulating biomarkers; (2) development of drugs to slow disease progression and (3) early valve intervention guided by medical imaging. Existing biomarkers (troponin and brain natriuretic peptide) are non-specific, but cost-effective predictors of ventricular dysfunction. In addition, their integration with cardiovascular MRI can provide accurate risk stratification, aiding aortic valve replacement decision making. Currently, invasive intervention is the only treatment for AS. In comparison, the development of lipoprotein(a) lowering therapies could provide an alternative; slowing progression of CAS, preventing left ventricular dysfunction and reducing reliance on surgical intervention.The landscape of AS management is rapidly evolving. This review outlines current understanding of the pathophysiology of AS, its management and future perspectives for the condition's assessment and treatment.

Routine cerebral embolic protection in transcatheter aortic valve implantation: rationale and design of the randomised British Heart Foundation PROTECT-TAVI trial.

Transcatheter aortic valve implantation (TAVI) is an established treatment for aortic stenosis. Cerebral embolic protection (CEP) devices may impact periprocedural stroke by capturing debris destined for the brain. However, there is a lack of high-quality randomised trial evidence supporting the use of CEP during TAVI. The British Heart Foundation (BHF) PROTECT-TAVI trial will address whether the routine use of CEP reduces the incidence of stroke in patients undergoing TAVI. BHF PROTECT-TAVI is a prospective, open-label, outcome-adjudicated, multicentre randomised controlled trial. The trial is open to all adult patients scheduled for TAVI at participating specialist cardiac centres across the United Kingdom who are able to receive the CEP device. The trial will recruit 7,730 participants. Participants will be randomised in a 1:1 ratio to undergo TAVI with CEP or TAVI without CEP (standard of care). The primary outcome is the incidence of stroke at 72 hours post-TAVI. Key secondary outcomes include the incidence of stroke and all-cause mortality up to 12 months post-TAVI, disability and cognitive outcomes, stroke severity, access site complications and a health economics analysis. The sample size of 7,730 participants has 80% power to detect a 33% relative risk reduction from a 3% incidence of the primary outcome in the controls. Trial recruitment commenced in October 2020. As of October 2022, 3,068 patients have been enrolled. BHF PROTECT-TAVI is designed to provide definitive evidence on the clinical efficacy and cost-effectiveness of using routine CEP with the SENTINEL device to reduce stroke in TAVI.

Valvular Heart Disease: New Concepts in Pathophysiology and Therapeutic Approaches.

This review discusses recent advancements in the field of valvular heart disease. Topics covered include recognition of the impact of atrial fibrillation on development and assessment of valvular disease, strategies for global prevention of rheumatic heart disease, understanding and management of secondary mitral regurgitation, the updated classification of bicuspid aortic valve disease, recognition of heightened cardiovascular risk associated with moderate aortic stenosis, and a growing armamentarium of transcatheter therapies.

Transcatheter aortic valve implantation in patients with severe symptomatic aortic valve stenosis: systematic review of cost-effectiveness analysis.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is a less invasive and costly treatment for patients with severe aortic stenosis (AS). This study aimed to systematically review the published literature focusing on economic evaluation of TAVI compared with other alternative treatments in AS populations. METHODS: A systematic review was conducted from inception until May 2021 using PubMed, Scopus, Web of science and Embase databases. The qualities of included studies were evaluated using Consolidated Health Economic Evaluation Reporting Standard (CHEERS) criteria. Data of costs, outcomes, incremental cost-effectiveness ratio (ICER) and willingness to pay were extracted. To compare results, ICERs were converted to the 2020 United States dollar (USD) rate. RESULTS: Of the 29 included cost-effectiveness studies, TAVI was cost-effective in all studies in the low-risk group (3/3), 77% of studies (7/9) in the intermediate-risk group, half of the studies (6/12) in the high-risk group, and 83% of studies (10/12) in the inoperable group. When adjusted to USD 2020, ICERs ranged from USD 2741 to 1027,674 USD per quality-adjusted life-year gained. The overall quality of the studies ranged from moderate to high. CONCLUSIONS: TAVI is potentially a cost-effective alternative to surgical aortic valve replacement (SAVR) for patients with operable AS with low, intermediate or high risk compared with medical management (MM) for patients with inoperable AS. TAVI was associated with a significant gain in quality-adjusted life-years in almost all studies compared to either SAVR or MM. TAVI is a costly procedure; therefore, justifying its cost-effectiveness depends on the acceptable threshold in each country.

What matters most to patients with severe aortic stenosis when choosing treatment? Framing the conversation for shared decision making.

BACKGROUND: Guidelines recommend including the patient's values and preferences when choosing treatment for severe aortic stenosis (sAS). However, little is known about what matters most to patients as they develop treatment preferences. Our objective was to identify, prioritize, and organize patient-reported goals and features of treatment for sAS. METHODS: This multi-center mixed-methods study conducted structured focus groups using the nominal group technique to identify patients' most important treatment goals and features. Patients separately rated and grouped those items using card sorting techniques. Multidimensional scaling and hierarchical cluster analyses generated a cognitive map and clusters. RESULTS: 51 adults with sAS and 3 caregivers with experience choosing treatment (age 36-92 years) were included. Participants were referred from multiple health centers across the U.S. and online. Eight nominal group meetings generated 32 unique treatment goals and 46 treatment features, which were grouped into 10 clusters of goals and 11 clusters of features. The most important clusters were: 1) trust in the healthcare team, 2) having good information about options, and 3) long-term outlook. Other clusters addressed the need for and urgency of treatment, being independent and active, overall health, quality of life, family and friends, recovery, homecare, and the process of decision-making. CONCLUSIONS: These patient-reported items addressed the impact of the treatment decision on the lives of patients and their families from the time of decision-making through recovery, homecare, and beyond. Many attributes had not been previously reported for sAS. The goals and features that patients' value, and the relative importance that they attach to them, differ from those reported in clinical trials and vary substantially from one individual to another. These findings are being used to design a shared decision-making tool to help patients and their clinicians choose a treatment that aligns with the patients' priorities. TRIAL REGISTRATION: ClinicalTrials.gov, Trial ID: NCT04755426, Trial URL https://clinicaltrials.gov/ct2/show/NCT04755426.

The Transaxillary Route as a Second Access Option in TAVI Procedures: Experience of a Single Centre.

Background: The aim of our study was to determine the feasibility and efficacy of transaxillary (TAX) TAVI in patients not eligible for the transfemoral route. Methods: This is a retrospective study of a single center. We analysed 262 patients treated with TAVI. In 17 patients (6.5%), the procedure was performed with the TAX approach. Procedural and hospital data, 30-day safety, and clinical efficacy were assessed and compared between the transfemoral and TAX groups. Results: In the TAX groups, we found a higher prevalence of men (p = 0.001), smokers (p = 0.033), and previous strokes (p = 0.02). The EUROSCORE II was higher in the TAX group (p = 0.014). The success rate of the device was 100%. TAX was associated with a longer procedure time (p = 0.001) and shorter median device time (p = 0.034) in minutes. Patients treated with TAX had a longer hospital stay (p = 0.005) and higher overall bleeding rate (p = 0.001). Peripheral neurological complications were more frequent with TAX (p = 0.001), which almost completely resolved by 30 days. Conclusions: TAX TAVI is safe and effective and should be considered as a second choice when transfemoral TAVI is not feasible due to severe comorbidities.

Management of asymptomatic severe aortic stenosis: a systematic review and meta-analysis.

OBJECTIVES: The management of severe aortic stenosis mandates consideration of aortic valve intervention for symptomatic patients. However, for asymptomatic patients with severe aortic stenosis, recent randomised trials supported earlier intervention. We conducted a systematic review and meta-analysis to evaluate all the available data comparing the two management strategies. METHODS: PubMed, Cochrane and Web of Science databases were systematically searched from inception until 10 January 2022. The search key terms were 'asymptomatic', 'severe aortic stenosis' and 'intervention'. RESULTS: Meta-analysis of two published randomised trials, AVATAR and RECOVERY, included 302 patients and showed that early intervention resulted in 55% reduction in all-cause mortality (HR=0.45, 95% CI 0.24 to 0.86; I2 0%) and 79% reduction in risk of hospitalisation for heart failure (HR=0.21, 95% CI 0.05 to 0.96; I2 15%). There was no difference in risk of cardiovascular death between the two groups (HR=0.36, 95% CI 0.03 to 3.78; I2 78%). Additionally, meta-analysis of eight observational studies showed improved mortality in patients treated with early intervention (HR=0.38, 95% CI 0.26 to 0.56; I2 77%). CONCLUSION: This meta-analysis provides evidence that, in patients with severe asymptomatic aortic stenosis, early intervention reduces all-cause mortality and improves outcomes compared with conservative management. While this is very encouraging, further randomised controlled studies are needed to draw firm conclusions and identify the optimal timing of intervention. PROSPERO REGISTRATION NUMBER: CRD42022301037.

Lipoprotein(a) and its Significance in Cardiovascular Disease: A Review.

Importance: Lipoprotein(a) (Lp[a]) is a low-density lipoprotein (LDL) cholesterol-like particle bound to apolipoprotein(a). This novel marker of cardiovascular disease acts through induction of vascular inflammation, atherogenesis, calcification, and thrombosis. While an absolute risk threshold remains to be universally accepted, an estimated 20% to 25% of the global population have Lp(a) levels of 50 mg/dL or higher, a level noted by the European Atherosclerosis Society to confer increased cardiovascular risk. Observations: Compelling evidence from pathophysiological, observational, and genetic studies suggest a potentially causal association between high Lp(a) levels, atherosclerotic cardiovascular disease, and calcific aortic valve stenosis. Additional evidence has demonstrated that elevated Lp(a) levels are associated with a residual cardiovascular risk despite traditional risk factor optimization, including LDL cholesterol reduction. These findings have led to the formulation of the Lp(a) hypothesis, namely that Lp(a) lowering leads to cardiovascular risk reduction, intensifying the search for Lp(a)-reducing therapies. The ineffectiveness of lifestyle modification, statins, and ezetimibe to lower Lp(a); the modest Lp(a) reduction with proprotein convertase subtilisin/kexin type 9 inhibitors; the adverse effect profile and unclear cardiovascular benefit of pharmacotherapies such as niacin and mipomersen; and the impracticality of regular lipoprotein apheresis represent major challenges to currently available therapies. Nevertheless, emerging nucleic acid-based therapies, such as the antisense oligonucleotide pelacarsen and the small interfering RNA olpasiran, are generating interest because of their potent Lp(a)-lowering effects. Assessment of new-onset diabetes in patients achieving very low Lp(a) levels will be important in future trials. Conclusions and Relevance: Epidemiologic and genetic studies suggest a potentially causal association between elevated Lp(a) levels, atherosclerotic cardiovascular disease, and aortic valve stenosis. Emerging nucleic acid-based therapies have potent Lp(a)-lowering effects and appear safe; phase 3 trials will establish whether they improve cardiovascular outcomes.

Eficacia y seguridad del dispositivo de prótesis valvular aórtico percutáneo para estenosis aórtica severa / Efficacy and Safety of Percutaneous Aortic Valve Prosthesis Device for Severe Aortic Stenosis

INTRODUCCIÓN: La Estenosis Aórtica (EA) es la valvulopatía más frecuente en el mundo, cuya incidencia se va incrementando con el envejecimiento de la población; su etiología se asocia a la calcificación de la válvula con una prevalencia del 50%-70% en pacientes de la tercera edad; que por lo general son individuos que poseían una válvula aórtica anatómicamente normal que desarrolla calcificación entre la sexta y séptima década de la vida. La estenosis aórtica severa es una condición que afecta a las personas en edad avanzada, consiste en la obstrucción del flujo sanguíneo a través de la válvula aórtica debido a la fibrosis y calcificación de la misma, comprendida como un área de la válvula aórtica (AVA) 40 mm Hg y/o una velocidad máxima del chorro aórtico (Vmax) >4 m/s. Un 30% del total de pacientes que padecen estenosis aórtica severa tienen riesgo quirúrgico muy elevado para cirugía convencional. Entre ellos figuran los pacientes de edad avanzada, a quienes se les debe evitar este tipo de cirugía, así como la circulación extracorpórea. Uno de los tratamientos más recientes para esta condición médica es el reemplazo percutáneo de la válvula aórtica o reemplazo transcatéter de la válvula aórtica. El Implante o reemplazo transcatéter de válvula aórtica, es una técnica en la que se puede implantar una válvula aórtica artificial guiada a través de un catéter introducido por punción de una arteria (femoral, axilar, aorta) o por la punta del corazón (vía apical). Todo ello sin parar el corazón ni necesitar seccionar de forma completa el esternón (como en la cirugía convencional) ni usar circulación extracorpórea El objetivo de la presente Evaluación de tecnología sanitaria (ETS) es evaluar la eficacia y seguridad, así como documentos relacionados a la decisión de cobertura con el del dispositivo prótesis valvular aórtico percutáneo o transcatéter de válvula aórtica en el tratamiento de pacientes con estenosis aórtica severa y con elevado riesgo quirúrgico o inoperables por cirugía convencional. METODOLOGÍA: Se realizó una búsqueda en las principales bases de datos bibliográficas: MEDLINE, LILACS, COCHRANE, así como en buscadores genéricos de Internet incluyendo Google Scholar y TRIPDATABASE, hasta el 11 de mayo de 2022. Adicionalmente, se hizo una búsqueda dentro de la información generada por las principales agencias de tecnologías sanitarias y guías de práctica clínica. RESULTADOS: Se identificaron 9 Revisiones sistemáticas (RS), 4 Evaluación de Tecnologías Sanitarias (ETS) y una evaluación económica (EC) realizada para Chile. No se identificaron EC para Perú, ni Guías de Práctica Clínica (GPC) que puedan responder la pregunta PICO. La más reciente revisión sistemática del año 2021, incorpora la evidencia actualizada de los dos grandes ensayos clínicos que responden la pregunta, mientras que las demás RS incluyen parte de estos ensayos. La evaluación de la calidad de la RS más reciente ha sido valorada como baja debido a que solo presenta un criterio crítico. CONCLUSIONES: La evidencia identificada en relación al implante valvular aórtico percutáneo para estenosis aórtica severa en pacientes con elevado riesgo quirúrgico, encontró que no se encuentran diferencias estadísticamente significativas entre ambos grupos en los desenlaces de: mortalidad por todas las causas, mortalidad por causa cardiovascular, stroke, stroke mayor discapacitante, infarto de miocardio, endocarditis, reintervención o reparación, hasta luego de 5 años de seguimiento. Se observó un menor riesgo para TAVI comparado con SAVR para los desenlaces: sangrado mayor, nuevo inicio o empeoramiento de fibrilación auricular. Por otro lado, se observó un mayor riesgo con TAVI comparado con SAVR para complicaciones vasculares mayores e implantación de marcapasos permanente.

Lipoprotein(a): a risk factor for atherosclerosis and an emerging therapeutic target.

Lipoprotein(a) (Lp(a)) is a complex circulating lipoprotein, and increasing evidence has demonstrated its role as a risk factor for atherosclerotic cardiovascular disease (ASCVD) and as a possible therapeutic target. Lp(a) atherogenic effects are attributed to several potential mechanisms in addition to cholesterol accumulation in the arterial wall, including proinflammatory effects mainly mediated by oxidised phospholipids. Several studies have found a causal and independent relationship between Lp(a) levels and cardiovascular risk. Furthermore, several studies also suggest a causal association between Lp(a) levels and calcific aortic valve stenosis. Available lipid-lowering agents have at best moderate impact on Lp(a) levels. Among available therapies, antibody proprotein convertase subtilisin/kexin type 9 inhibitors are the most effective in reducing Lp(a). Potent Lp(a)-lowering treatments that target LPA expression are under development. Lp(a) level measurement poses some challenges due to the absence of a definitive reference method and the reporting of Lp(a) values as molar (nanomoles per litre (nmol/L)) or mass concentrations (milligrams per decilitre (mg/dL)) by different assays. Currently, Lp(a) measurement is recommended to refine cardiovascular risk in specific clinical settings, that is, in individuals with a family history of premature ASCVD, in patients with ASCVD not explained by standard risk factors or in those with recurrent events despite optimal management of traditional risk factors. Patients with high Lp(a) levels should be managed with more intensive approaches to treat other modifiable cardiovascular risk factors. Overall, this review focuses on Lp(a) as an ASCVD risk factor and therapeutic target. Furthermore, it reports practical recommendations for Lp(a) measurement and interpretation and updated evidence on Lp(a)-lowering approaches.

Aortic Valve Replacement Versus Conservative Treatment in Asymptomatic Severe Aortic Stenosis: The AVATAR Trial.

BACKGROUND: Surgical aortic valve replacement (SAVR) represents a class I indication in symptomatic patients with severe aortic stenosis (AS). However, indications for early SAVR in asymptomatic patients with severe AS and normal left ventricular function remain debated. METHODS: The AVATAR trial (Aortic Valve Replacement Versus Conservative Treatment in Asymptomatic Severe Aortic Stenosis) is an investigator-initiated international prospective randomized controlled trial that evaluated the safety and efficacy of early SAVR in the treatment of asymptomatic patients with severe AS, according to common criteria (valve area ≤1 cm2 with aortic jet velocity >4 m/s or a mean transaortic gradient ≥40 mm Hg), and with normal left ventricular function. Negative exercise testing was mandatory for inclusion. The primary hypothesis was that early SAVR would reduce the primary composite end point of all-cause death, acute myocardial infarction, stroke, or unplanned hospitalization for heart failure compared with a conservative strategy according to guidelines. The trial was designed as event-driven to reach a minimum of 35 prespecified events. The study was performed in 9 centers in 7 European countries. RESULTS: Between June 2015 and September 2020, 157 patients (mean age, 67 years; 57% men) were randomly allocated to early surgery (n=78) or conservative treatment (n=79). Follow-up was completed in May 2021. Overall median follow-up was 32 months: 28 months in the early surgery group and 35 months in the conservative treatment group. There was a total of 39 events, 13 in early surgery and 26 in the conservative treatment group. In the early surgery group, 72 patients (92.3%) underwent SAVR with operative mortality of 1.4%. In an intention-to-treat analysis, patients randomized to early surgery had a significantly lower incidence of primary composite end point than those in the conservative arm (hazard ratio, 0.46 [95% CI, 0.23-0.90]; P=0.02). There was no statistical difference in secondary end points, including all-cause mortality, first heart failure hospitalizations, major bleeding, or thromboembolic complications, but trends were consistent with the primary outcome. CONCLUSIONS: In asymptomatic patients with severe AS, early surgery reduced a primary composite of all-cause death, acute myocardial infarction, stroke, or unplanned hospitalization for heart failure compared with conservative treatment. This randomized trial provides preliminary support for early SAVR once AS becomes severe, regardless of symptoms. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02436655.

Professionals' views on shared decision-making in severe aortic stenosis.

OBJECTIVE: To provide insight into professionals' perceptions of and experiences with shared decision-making (SDM) in the treatment of symptomatic patients with severe aortic stenosis (AS). METHODS: A semistructured interview study was performed in the heart centres of academic and large teaching hospitals in the Netherlands between June and December 2020. Cardiothoracic surgeons, interventional cardiologists, nurse practitioners and physician assistants (n=21) involved in the decision-making process for treatment of severe AS were interviewed. An inductive thematic analysis was used to identify, analyse and report patterns in the data. RESULTS: Four primary themes were generated: (1) the concept of SDM, (2) knowledge, (3) communication and interaction, and (4) implementation of SDM. Not all respondents considered patient participation as an element of SDM. They experienced a discrepancy between patients' wishes and treatment options. Respondents explained that not knowing patient preferences for health improvement hinders SDM and complicating patient characteristics for patient participation were perceived. A shared responsibility for improving SDM was suggested for patients and all professionals involved in the decision-making process for severe AS. CONCLUSIONS: Professionals struggle to make highly complex treatment decisions part of SDM and to embed patients' expectations of treatment and patients' preferences. Additionally, organisational constraints complicate the SDM process. To ensure sustainable high-quality care, professionals should increase their awareness of patient participation in SDM, and collaboration in the pathway for decision-making in severe AS is required to support the documentation and availability of information according to the principles of SDM.