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"Akodad, Mariama"
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Head-to-head comparison of balloon-expandable transcatheter heart valves
2025
Transcatheter aortic valve intervention (TAVI) is a well established therapy for severe aortic stenosis, demonstrating excellent mid-term outcomes in patients across all surgical risk groups. 1,2 Valve durability and repeatability are key concepts when considering young (ie, aged <75 years) patients with low surgical risk and increased life expectancy, who might therefore outlive their bioprosthetic valve. 3 Short-frame balloon-expandable transcatheter heart valves (THVs) are suitable in most anatomies and offer potential for a second TAVI procedure in most cases. 4 However, randomised trials have shown higher gradients in patients with small annuli treated with balloon-expandable intra-annular SAPIEN 3 THVs than with self-expandable supra-annular THVs, without showing clear clinical impact. 5 Thus, a tailored approach based on patient characteristics and anatomical features from CT scan is required to avoid immediate complications, to ensure optimal THV function and anticipate repeatability. 3 The SAPIEN 3 THV series is widely used in clinical practice and has shown good outcomes. 2 The newest balloon-expandable THV, Myval, offers intermediate sizes (1·5 mm diameter increments vs 3 mm for SAPIEN 3) thus improving sizing accuracy. 6 Furthermore, larger Myval THVs are available to treat large annuli (270–840 mm 2), which are often too large for any available THV platforms. Since overexpansion or underexpansion of THVs can affect leaflet function, THV haemodynamics, and valve durability, more appropriate sizing seems desirable. Myval THVs were non-inferior to SAPIEN 3 THVs regarding the primary composite endpoint of all-cause mortality, stroke, moderate or severe aortic regurgitation, or moderate or severe valve deterioration at 1 year (71 [14%] of 514 patients vs 67 [13%] of 517 patients), which met the prespecified non-inferiority margin (risk difference –0·9% [one-sided upper 95% CI –4·4]; p non-inferiority=0·019). Aortic valve area was smaller and mean gradient were higher in patients treated with SAPIEN 3 THVs, supporting the findings from the post-hoc analysis of the LANDMARK trial. 7 The different design of the Myval THVs that enables a larger effective leaflet opening might explain this finding. 6,7 Nevertheless, the latest SAPIEN Ultra Resilia technology that is associated with higher effective orifice area than SAPIEN THVs due to different leaflet attachment to the THV frame was not used in the study by Terkelsen and colleagues. 9 Thus, Myval THVs versus SAPIEN 3 Ultra Resilia THV might have yielded different haemodynamics.
Journal Article
Complex Transfemoral Access During Transcatheter Aortic Valve Replacement: A Narrative Review of Management, Complexity Scores, and Alternative Access
by
Garot, Philippe
,
Sanguineti, Francesca
,
Lounes, Youcef
in
alternative vascular access
,
Aorta
,
Aortic stenosis
2025
Transcatheter aortic valve replacement (TAVR) has become a well-established treatment for severe aortic stenosis across all levels of surgical risk. While transfemoral access remains the default approach, complications arising from vascular access—especially in patients with peripheral artery disease (PAD)—pose significant challenges. Hostile vascular access, characterized by narrow vessel diameters, severe calcification, and tortuosity, complicates the procedure and necessitates alternative strategies. Recent advancements, such as intravascular lithotripsy (IVL), have shown promise in managing severely calcified arteries, improving the feasibility of transfemoral TAVR in patients previously considered ineligible. IVL uses pulsatile sonic waves to fragment arterial calcifications, enhancing vessel compliance and facilitating safe device delivery. Studies have demonstrated that IVL-assisted TAVR improves procedural success and reduces complications in patients with PAD. Additionally, orbital atherectomy, an adjunctive therapy targeting both concentric and eccentric calcifications, may complement the management of complex arterial calcification. The Hostile and passage–puncture scores offer valuable risk stratification tools for predicting vascular complications, aiding in better access site selection. Post-procedural echocardiography, particularly femoral artery sonography, may also play a role in detecting vascular complications early, enabling timely intervention. Finally, alternative access sites are increasingly being explored, with emerging data helping to guide the final access site decision. As TAVR continues to expand into lower risk populations, optimizing vascular access strategies remains essential to improving procedural outcomes. This review highlights the importance of preoperative imaging, endovascular techniques, and post-procedural monitoring in overcoming vascular challenges and ensuring successful TAVR outcomes.
Journal Article
Artificial Intelligence and Advanced Digital Health for Hypertension: Evolving Tools for Precision Cardiovascular Care
by
Garot, Philippe
,
Sanguineti, Francesca
,
D’Angelo, Livio
in
Algorithms
,
Antihypertensives
,
Artificial intelligence
2025
Background: Hypertension remains the leading global risk factor for cardiovascular morbidity and mortality, with suboptimal control rates despite guideline-directed therapies. Digital health and artificial intelligence (AI) technologies offer novel approaches for improving diagnosis, monitoring, and individualized treatment of hypertension. Objectives: To critically review the current landscape of AI-enabled digital tools for hypertension management, including emerging applications, implementation challenges, and future directions. Methods: A narrative review of recent PubMed-indexed studies (2019–2024) was conducted, focusing on clinical applications of AI and digital health technologies in hypertension. Emphasis was placed on real-world deployment, algorithmic explainability, digital biomarkers, and ethical/regulatory frameworks. Priority was given to high-quality randomized trials, systematic reviews, and expert consensus statements. Results: AI-supported platforms—including remote blood pressure monitoring, machine learning titration algorithms, and digital twins—have demonstrated early promise in improving hypertension control. Explainable AI (XAI) is critical for clinician trust and integration into decision-making. Equity-focused design and regulatory oversight are essential to prevent exacerbation of health disparities. Emerging implementation strategies, such as federated learning and co-design frameworks, may enhance scalability and generalizability across diverse care settings. Conclusions: AI-guided titration and digital twin approaches appear most promising for reducing therapeutic inertia, whereas cuffless blood pressure monitoring remains the least mature. Future work should prioritize pragmatic trials with equity and cost-effectiveness endpoints, supported by safeguards against bias, accountability gaps, and privacy risks.
Journal Article
Comparative Effectiveness of Peripheral Angioplasty Strategies for 1-Year Restenosis in Lower Limb Artery Disease: A Retrospective Single-Center Analysis
by
Garot, Philippe
,
Lounes, Youcef
,
Sanguineti, Francesca
in
Angiography
,
Angioplasty
,
Balloon treatment
2025
Background: Optimal endovascular strategy for lower limb peripheral artery disease (PAD) remains debated, particularly regarding 1-year restenosis. Aim: To evaluate the association between drug-coated balloon (DCB)-based angioplasty and 1-year restenosis compared with stent-based and plain balloon strategies in a real-world PAD cohort. Methods: We performed a single-center retrospective analysis of 283 consecutive patients (mean age 67.5 ± 11.2 years, 79% male) undergoing lower limb angioplasty between 2010 and 2023. Patients were treated with one of five strategies: direct stent, pre-dilatation + stent, stent + post-dilatation, DCB ± bailout stent, or plain old balloon angioplasty (POBA). Restenosis at 12 months (≥50% diameter reduction on Doppler, CT angiography, or angiography) was the primary endpoint. Kaplan-Meier curves and multivariable Cox regression adjusted for clinical and lesion characteristics were used. The prespecified main comparison was DCB ± stent versus non-DCB strategies. Results: Overall, 1-year restenosis occurred in 81 patients (28.7%). Restenosis rates were 15.4% with DCB ± stent versus 34.2%, 29.8%, 31.5%, and 38.1% with direct stent, pre-dilatation + stent, stent + post-dilatation, and POBA, respectively (p = 0.004). In adjusted analysis, DCB ± stent was associated with a lower hazard of restenosis compared with direct stent (HR 0.52; 95% CI 0.31–0.87), whereas POBA was associated with a higher hazard versus DCB ± stent (HR 1.89; 95% CI 1.01–3.53). Periprocedural complication rates were low and similar across groups (overall 6.3%). Conclusions: In this real-world PAD cohort, DCB-based angioplasty was independently associated with lower 1-year restenosis compared with stent-based and plain balloon strategies, without an excess of procedural complications. Given the observational design and lesion-driven strategy selection, these findings should be interpreted as hypothesis-generating but support broader use of DCB in appropriately selected lesions.
Journal Article
New-generation Myval transcatheter heart valve in severe aortic stenosis
2024
Transcatheter aortic valve implantation (TAVI) has become a well established treatment option in patients with severe aortic stenosis, regardless of the surgical risk spectrum. 1,2 The refinement of techniques and broadening of indications have meant complication rates—including death, strokes, and vascular complications—have drastically decreased over time, 1,2 without serious concerns regarding transcatheter heart valve (THV) durability. 3 The current focus lies on a tailored approach, aiming to offer each patient the most suitable THV based on their specific anatomy and ensuring optimal haemodynamic performances after the index procedure and potential for repeatability in patients with increased longevity. The LANDMARK trial establishes the non-inferiority of Myval compared with contemporary THVs (25% vs 27%; risk difference –2·3% [one-sided upper 95% CI 3·8%], p non-inferiority<0·0001) for the 30-day composite endpoint (all-cause mortality, stroke, major bleeding, acute kidney injury, major vascular complications, moderate or severe prosthetic valve regurgitation, and permanent pacemaker implantation according to third Valve Academic Research Consortium criteria). The global inclusion rate of participants in this trial was only 15%, indicating high selection bias. [...]whether this new Myval THV offers long-term advantages over contemporary THVs is not yet established, especially for younger individuals, for whom repeatability and coronary access are key for lifetime management given the expected steady increase in the number of individuals with increased longevity. 9 Although commissural alignment does not seem feasible with the Sapien THV, recent promising data were published with Myval, 10 which could give it a valuable advantage for long-term outcomes.
Journal Article
Ultrasound-Guided Femoral Hemostasis in Peripheral Angioplasty: Real-World Outcomes with Vascular Closure Devices Versus Manual Compression
2025
Background and Objectives: Access-site complications (ASCs) remain clinically relevant after peripheral endovascular procedures, particularly with large femoral sheaths and complex anatomy. While randomized coronary trials show non-inferiority of vascular closure devices (VCDs) versus manual compression (MC), real-world data in peripheral interventions performed under systematic ultrasound-guided access are limited. Materials and Methods: This retrospective single-center cohort included consecutive peripheral arterial revascularizations (2010–2023) performed via common femoral access under real-time ultrasound guidance. Hemostasis was achieved using MC or VCDs, categorized as collagen plug-based, suture-mediated, or clip-based systems. The primary endpoint was 30-day ASCs, defined as hematoma requiring management, pseudoaneurysm, bleeding requiring transfusion, access-site thrombosis/occlusion, arteriovenous fistula, or infection. The secondary endpoint was VCD failure, defined as unsuccessful hemostasis requiring adjunctive measures. Multivariable logistic regression adjusted for prespecified anatomical and procedural covariates, including sheath size > 6 Fr and puncture-site calcification. Results: Among 231 procedures, VCDs were used in 139 (60.2%) and MC in 92 (39.8%). ASC occurred in 28 cases (12.1%), with higher rates in the MC group compared with VCDs (18.5% vs. 9–14% across device types; p = 0.044). In adjusted analyses, MC (vs any VCD) (odds ratio [OR] 2.41, 95% confidence interval [CI] 1.06–5.47; p = 0.035), sheath size > 6 Fr, and puncture-site calcification were independently associated with ASCs. VCD failure occurred in 5 cases (3.6%) and was not observed with collagen plug-based devices. Conclusions: In this ultrasound-guided real-world peripheral cohort, VCD use was associated with lower 30-day ASC rates and low device failure rates compared with MC. Given the retrospective and non-randomized design, these findings should be considered hypothesis-generating and support individualized, imaging-guided strategies for femoral closure in peripheral interventions.
Journal Article
Multimarker approach including CRP, sST2 and GDF‐15 for prognostic stratification in stable heart failure
2020
Aims Inflammation and cardiac remodelling are common and synergistic pathways in heart failure (HF). Emerging biomarkers such as soluble suppression of tumorigenicity 2 (sST2) and growth differentiation factor‐15 (GDF‐15), which are linked to inflammation and fibrosis process, have been proposed as prognosis factors. However, their potential additive values remain poorly investigated. Methods and results Here, we aimed at evaluating inflammatory and remodelling biomarkers to predict both short‐term and long‐term mortality in a population with chronic HF in comparison with other classical clinical or biological markers (i.e. N terminal pro brain natriuretic peptide, hs‐cTnT, C‐reactive protein) alone or using meta‐analysis global group in chronic HF risk score in a cohort of 182 patients followed during 80 months (interquartile range: 12.3–90.0). Proportional hazard assumption does not hold for sST2 and C‐reactive protein, and follow‐up was split into short term (less than 1 year), midterm (between 1 and 5 years), and long term (after 5 years). In univariate analysis, C‐reactive protein and sST2 were predictive of short‐term mortality but not of middle term and long term whereas GDF‐15 was predictive of short and mid‐term but not of long‐term mortality. In a multivariate model after adjustment for meta‐analysis global group in chronic HF score including the three markers, only sST2 was predictive of short‐term mortality (P = 0.0225), and only GDF‐15 was predictive of middle term mortality (P = 0.0375). None of the markers was predictive of long‐term mortality. Conclusions Our results demonstrate that both sST2 and GDF‐15 significantly improve the prognosis evaluation of HF patients and suggest that the value of GDF‐15 is more sustained overtime and could predict middle term events.
Journal Article
Hemodynamic Performances and Clinical Outcomes in Patients Undergoing Valve-in-Valve Versus Native Transcatheter Aortic Valve Implantation
by
Macia, Jean-Christophe
,
Lattuca, Benoit
,
Robert, Gabriel
in
Aged
,
Aged, 80 and over
,
Aortic stenosis
2019
Valve-in-valve (ViV) transcatheter aortic valve implantation (TAVI) emerged has a less invasive treatment than surgery for patients with degenerated bioprosthesis. However, few data are currently available regarding results of ViV versus TAVI in native aortic valve. We aimed to compare hemodynamic performances and 1-year outcomes between patients who underwent ViV procedure and patients who underwent non-ViV TAVI. This bicentric study included all patients who underwent aortic ViV procedure for surgical bioprosthetic aortic failure between 2013 and 2017. All patients who underwent TAVI were included in the analysis during the same period. ViV and non-ViV patients were matched with 1:2 ratio according to size, type of TAVI device, age (±5 years), sex, and STS score. Primary end point was hemodynamic performance including mean aortic gradient and aortic regurgitation at 1-year follow-up. A total of 132 patients were included, 49 in the ViV group and 83 in the non-ViV group. Mean age was 82.8 ± 5.9 years, 55.3% were female. Mean STS score was 5.2% ± 3.1%. Self-expandable valves were implanted in 78.8% of patients. At 1-year follow-up, aortic mean gradient was significantly higher in ViV group (18.1 ± 9.4 mm Hg vs 11.4 ± 5.4 mm Hg; p < 0.0001) and 17 (38.6%) patients had a mean aortic gradient ≥20 mm Hg vs 6 (7.8%) in the non-ViV group (p = 0.0001). Aortic regurgitation > grade 2 were similar in both groups (p = 0.71). In the ViV group, new pacemaker implantation was less frequent (p = 0.01) and coronary occlusions occurred only in ViV group (n = 2 [4.1%]). At 1-year follow-up, 3 patients (2.3%) died from cardiac cause, 1 (2.1%) in the ViV group vs 2 (2.4%) in the non-ViV group (p = 0.9). There was no stroke. In conclusion, compared with TAVI in native aortic stenosis, ViV appears as a safe and feasible strategy in patients with impaired bioprosthesis. As 1-year hemodynamic performances seem better in native TAVI procedure, long-term follow-up should be assessed to determinate the impact of residual stenosis on outcomes and durability.
Journal Article
Feasibility and Safety of Transcatheter Aortic Valve Implantation Performed Without Intensive Care Unit Admission
by
Macia, Jean-Christophe
,
Lattuca, Benoit
,
Robert, Gabriel
in
Aged
,
Aged, 80 and over
,
Aortic Valve Stenosis - complications
2016
Admission to the intensive care unit (ICU) is a standard of care after transcatheter aortic valve implantation (TAVI); however, the improvement of the procedure and the need to minimize the unnecessary use of medical resources call into question this strategy. We evaluated prospectively 177 consecutive patients who underwent TAVI. Low-risk patients, admitted to conventional cardiology units, had stable clinical state, transfemoral access, no right bundle branch block, permanent pacing with a self-expandable valve, and no complication occurring during the procedure. High-risk patients included all the others transferred to ICU. In-hospital events were the primary end point (Valve Academic Research Consortium 2 criteria). The mean age of patients was 83.5 ± 6.5 years, and the mean logistic EuroSCORE was 14.6 ± 9.7%. The balloon-expandable SAPIEN 3 valve was mainly used (n = 148; 83.6%), mostly with transfemoral access (n = 167; 94.4%). Among the 61 patients (34.5%) included in the low-risk group, only 1 (1.6%) had a minor complication (negative predictive value 98.4%, 95% confidence interval [CI] 0.91 to 0.99). Conversely, 31 patients (26.7%) from the high-risk group had clinical events (positive predictive value 26.7%, 95% CI 0.19 to 0.35), mainly conductive disorders requiring pacemaker (n = 26; 14.7%). In multivariate analysis, right bundle branch block (odds ratio [OR] 14.1, 95% CI 3.5 to 56.3), use of the self-expandable valve without a pacemaker (OR 5.5, 95% CI 2 to 16.3), vitamin K antagonist treatment (OR 3.8, 95% CI 1.1 to 12.6), and female gender (OR 2.6, 95% CI 1.003 to 6.9) were preprocedural predictive factors of adverse events. In conclusion, our results suggested that TAVI can be performed safely without ICU admission in selected patients. This strategy may optimize efficiency and cost-effectiveness of procedures.
Journal Article
Mobile Health Applications for Secondary Prevention After Myocardial Infarction or PCI: A Systematic Review and Meta-Analysis of Randomized Controlled Trials
by
Garot, Philippe
,
Tsigkas, Grigorios
,
Sanguineti, Francesca
in
Acute coronary syndromes
,
Angioplasty
,
Behavior
2025
Background: Mobile health applications have emerged as a novel tool to support secondary prevention after myocardial infarction (MI) or percutaneous coronary intervention (PCI). However, the impact of app-based interventions on clinically meaningful outcomes such as hospital readmissions remains uncertain. Objective: To systematically evaluate the effectiveness of smartphone app-based interventions in reducing unplanned hospital readmissions among post-MI/PCI patients. Methods: A systematic search of PubMed was conducted for randomized controlled trials published between January 2020 and April 2025. Eligible studies evaluated smartphone apps designed for secondary cardiovascular prevention and reported on unplanned hospital readmissions. Risk ratios (RRs) and 95% confidence intervals (CIs) were pooled using a random-effects model. Subgroup analyses were performed based on follow-up duration and user adherence. Results: Four trials encompassing 827 patients met inclusion criteria. App-based interventions were associated with a significant reduction in unplanned hospital readmissions compared to standard care (RR 0.45; 95% CI: 0.23–0.89; p = 0.0219). Greater benefits were observed in studies with longer follow-up durations and higher adherence rates. Improvements in patient-reported outcomes, including health-related quality of life, were also documented. Heterogeneity was moderate. Major adverse cardiovascular events (MACEs) were reported in only two studies and were not analyzed due to inconsistent definitions and low event rates. Conclusions: Smartphone applications for post-MI/PCI care are associated with reduced unplanned hospital readmissions and improved patient-reported outcomes. These tools may play a meaningful role in future cardiovascular care models, especially when sustained engagement and personalized features are prioritized.
Journal Article