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LANDMARK: 2-Year Data Show Continued Safety and Efficacy of Unique TAVI Valve - TCTMD.com
LANDMARK: 2-Year Data Show Continued Safety and Efficacy of Unique TAVI Valve TCTMD.com
May 29, 2026E. Nolan Beckett, MD · Editor
LANDMARK: 2-Year Data Show Continued Safety and Efficacy of Unique TAVI Valve TCTMD.com
The high costs of robotic tech | Medtronic recalls thousands of devices | TAVR in younger patients | FDA approves next-gen valve Cardiovascular Business
Josh Brown's 'best stocks in the market': Edwards Lifesciences CNBC
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The LANDMARK 2-year readout extends Myval (Meril Life Sciences) noninferiority versus SAPIEN and Evolut on the composite of death, stroke, and valve-related hospitalization. The 1-year arms overlapped at 87.0% versus 86.9% freedom from events; the 2-year curve, per TCTMD's coverage, continues to track that pattern. A third balloon-expandable option with a credible RCT comparator is relevant for procurement decisions and European operator choice. It is not relevant to the durability question that defines treatment selection for patients under 70. The signal that matters is hemodynamic performance and structural valve deterioration at 5 and 10 years, and LANDMARK isn't there yet. ESC 2025 still recommends SAVR for patients under 70 with low surgical risk (Class I, defined as STS-PROM + EuroSCORE II <4%); ACC/AHA 2020 holds SAVR as the default under 65.
The renewed press attention to "TAVR in younger patients" sits awkwardly against published mid-term data showing patients aged 50–70 with mechanical aortic prostheses outperforming bioprosthetic recipients on long-term survival — with size 19-mm biological valves showing the worst outcomes and severe patient-prosthesis mismatch carrying the lowest survival. A wider THV menu does not change the lifetime-management calculus for a 62-year-old; it changes the marketing.
LANDMARK: 2-Year Data Show Continued Safety and Efficacy of Unique TAVI Valve TCTMD.com
The high costs of robotic tech | Medtronic recalls thousands of devices | TAVR in younger patients | FDA approves next-gen valve Cardiovascular Business
Josh Brown's 'best stocks in the market': Edwards Lifesciences CNBC
Edwards Lifesciences CVP Donald Bobo Jr. sells $2m in stock Investing.com Australia
Background: Because of demographic changes, the number of older patients undergoing cardiac interventions has increased. The most common indication in this group is aortic valve stenosis, treated with either surgical aortic valve replacement (SAVR) or transcatheter aortic valve implantation (TAVR), with good outcomes. Our study investigated whether the heart team's choice of intervention (TAVI, SAVR, or conservative) is influenced by geriatric assessment results. Methods: This study was a single-centre, prospective, longitudinal case-control study conducted over 12 months and did not affect routine diagnostic examinations or clinical decisions. After risk stratification and clinical evaluation, patients were assigned to undergo TAVI, SAVR, or conservative management. Cardiological evaluation and geriatric assessment were performed for up to 12 months. Results: Of 135 patients (mean age 81 ± 4.6 years), 60% underwent TAVI, 29% SAVR, and 11% conservative therapy. Age, Frailty Score, cognition, and nutritional status were significantly associated with the heart team's decision, whereas EuroSCORE II remained the only independent predictor of one-year mortality (OR 1.58, 95% CI 1.13-2.19, p = 0.007). One-year mortality was 9.9% (n = 11). Compared to the literature, one-year mortality was lower than expected, particularly in the intervention group. Conclusions: Single assessment tools did not have the power to predict mortality. Similar to other trials, a combination of different scores can assess the risk of mortality.
Background and Objectives: Transcatheter edge-to-edge repair (TEER) has emerged as an effective treatment option for patients with severe mitral regurgitation who are at high surgical risk. However, clinical outcomes after TEER remain heterogeneous and are influenced not only by cardiac parameters but also by systemic comorbidities and multiorgan dysfunction. The albumin-bilirubin (ALBI) score, derived from serum albumin and bilirubin levels, has recently been proposed as a simple marker of hepatic dysfunction and cardio-hepatic interaction. This study aimed to evaluate the prognostic value of baseline ALBI score in predicting long-term mortality after TEER. Materials and Methods: In this single-center retrospective cohort study, 106 consecutive patients with symptomatic moderate-to-severe or severe mitral regurgitation who underwent TEER between January 2019 and December 2025 were included. Baseline ALBI score was calculated using pre-procedural serum albumin and bilirubin levels. Cox proportional hazards regression analysis was used to identify predictors of long-term mortality. Variable selection was performed using least absolute shrinkage and selection operator (LASSO) regression, followed by ridge-penalized multivariable Cox modeling to minimize overfitting. The incremental prognostic value of ALBI was assessed using concordance index (C-index) comparison between predictive models. Receiver operating characteristic (ROC) analysis and Kaplan-Meier survival analysis were also performed. Results: During a median follow-up of 17.9 months, 30 patients (28.3%) died. Higher baseline ALBI scores were significantly associated with increased mortality risk. In multivariable analysis, ALBI score (HR 3.35, 95% CI 1.46-7.71; p = 0.004), left atrial volume index (LAVI) (HR 1.02, 95% CI 1.01-1.03; p = 0.005), and log-transformed B-type natriuretic peptide (BNP) (HR 1.37, 95% CI 1.02-1.86; p = 0.039) remained independent predictors of mortality. Addition of the ALBI score improved model discrimination, increasing the C-index from 0.845 to 0.886. ROC analysis demonstrated good predictive performance of the ALBI score (area under the curve [AUC] = 0.877), with an optimal cut-off value of -1.67. Conclusions: Baseline ALBI score is independently associated with long-term mortality after TEER and may provide potential incremental prognostic information. However, the observed improvement is modest and should be interpreted cautiously. These findings support a potential role of ALBI as a complementary marker, which requires validation in larger prospective studies.
Aortic stenosis (AS) and mitral stenosis (MS) are progressive valvular heart diseases associated with substantial morbidity and mortality once symptoms develop. Over the past decade, the management of isolated AS has undergone profound evolution, driven by refinements in surgical aortic valve replacement, the adoption of minimally invasive techniques, and the rapid expansion of transcatheter aortic valve replacement across all surgical risk categories. In contrast, patients with concomitant AS and MS represent a complex and understudied population, frequently excluded from randomized trials and only marginally addressed in contemporary clinical practice guidelines. The management requires individualized guideline-directed decision-making led by a multidisciplinary Heart Team. The paucity of high-quality data in combined AS-MS underscores the need for dedicated prospective studies and international registries. The aim of this narrative review is to describe current strategies to treat AS both when isolated and concomitant with MS. We also discuss the need for updated, specific guidelines.
Background and objectives: Valve-in-valve transcatheter aortic valve replacement (ViV TAVR) has become an established treatment for failed surgical bioprostheses in patients at high surgical risk. However, procedures performed in degenerated stentless aortic valves remain particularly challenging because of the absence of a radiopaque frame, variable surgical implantation techniques, and a potentially increased risk of coronary obstruction. Evidence in this specific setting is limited. We conducted a systematic review of the literature to identify studies reporting ViV TAVI in degenerated stentless surgical bioprostheses. Materials and methods: Case reports and case series were included when patient-level or clearly identifiable data were available. Baseline characteristics, anatomical features, procedural strategies, and clinical outcomes were extracted and analyzed using a descriptive approach. A total of 54 studies were included, encompassing 294 ViV TAVI procedures performed in failed stentless aortic valves. Results: The mean patient age was 73.9 years, and the average STS-PROM score was 13.45%, reflecting a high-risk population. The most frequently treated prosthesis was the Medtronic Freestyle valve, and the predominant mechanism of failure was regurgitation. Transfemoral access represented the most common approach, while balloon-expandable and self-expanding transcatheter valves were used with similar frequency. Coronary protection strategies were adopted in a minority of procedures, whereas adjunctive procedural techniques such as pre- or post-dilation were relatively common. Device-related complications were mainly driven by coronary obstruction, while cardiac complications included myocardial infarction and unplanned coronary intervention. Overall, VARC-3 device success was achieved in the majority of procedures, with acceptable short-term mortality despite the complexity of the treated population. Conclusions: ViV TAVR in degenerated stentless bioprostheses appears feasible and generally effective but remains associated with specific procedural challenges, particularly related to coronary obstruction risk. Careful anatomical assessment and tailored procedural planning are essential, and larger contemporary studies are needed to better define optimal management strategies in this complex setting.
Aortic valve stenosis (AS) is assessed by echocardiography in clinical practice. Conventionally, the aortic valve area, peak transaortic valve velocity/gradient and the mean transvalvular gradient determine if the AS is categorized as mild, moderate or severe. Recently, the entity of paradoxical low-flow, low-gradient AS despite normal left ventricular ejection fraction (LVEF) was described and flow (as determined by stroke volume indexed to body surface area) was used to further categorize AS. The new European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS) guidelines in 2025 recommended a new phenotype-based classification, which improved the prognostication of AS. There are now five phenotypes: (1) concordant high-gradient AS; (2) low-flow, low-gradient AS with reduced LVEF; (3) low-flow, low-gradient AS with preserved LVEF; (4) normal-flow, low-gradient AS with preserved LVEF; and (5) discordant high-gradient AS. These appear to have different underlying pathophysiology, and hence prognostication and therapy. In addition, categories of AS in the setting of reduced LVEF are further divided based on their responses to dobutamine or exercise stress, which may result in different therapeutic strategies. In the transaortic valvular replacement (TAVR) versus the surgical aortic valve replacement (SAVR) era, the classification of these AS groups may have differing implications on the appropriate interventions. Furthermore, there are investigations on the effect of AS on the left ventricle and other chambers and stages of AS based on the extent of cardiac damage, which may have important prognostic value post-AVR. On the other spectrum, there are new developments in imaging analysis, such as using artificial intelligence. This state-of-the-art paper will comprehensively review the important updates in AS and its clinical implications.
Two regulatory threads moved in opposite directions in the same news cycle: FDA cleared a next-generation transcatheter valve, and Medtronic is recalling thousands of devices, per Cardiovascular Business. Device-class scope on the Medtronic recall wasn't broken out in the rollup; clinicians should check the FDA recall database against their current Structural Heart inventory before next week's elective list. The juxtaposition matters: the same regulatory machinery clearing accelerated next-gen approvals is the one issuing the post-market corrections.
FDA confirms Class I recall for vascular device used by cardiologists and surgeons Cardiovascular Business
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Tracked enrollment and outcomes ... full record on ClinicalTrials.gov.
Tracked enrollment and outcomes ... full record on ClinicalTrials.gov.
Tracked enrollment and outcomes ... full record on ClinicalTrials.gov.
Tracked enrollment and outcomes ... full record on ClinicalTrials.gov.
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