Symptomatic Aortic Stenosis Research Articles

Cost-effectiveness analysis of transcatheter aortic valve implantation versus surgical aortic valve replacement in patients with severe aortic stenosis at low risk of surgical mortality in Sweden

Background: Transcatheter aortic valve implantation (TAVI) has shown similar or improved clinical outcomes compared with surgical aortic valve replacement (SAVR) in patients with symptomatic severe aortic stenosis at low risk for surgical mortality. This cost-utility analysis compared TAVI with SAPIEN 3 versus SAVR in symptomatic severe aortic stenosis patients at low risk of surgical mortality from the perspective of the Swedish healthcare system. Methods: A published, two-stage, Markov-based cost-utility model that captured clinical outcomes from the Swedish Web-system for Enhancement and Development of Evidence-based care in Heart disease Evaluated according to Recommended Therapies (SWEDEHEART) registry (2018–2020) was adapted from the perspective of the Swedish healthcare system using local general population mortality, utility and costs data. The model had a lifetime horizon. Model outputs included changes in direct healthcare costs and health-related quality of life from using TAVI as compared with SAVR. Results: TAVI with SAPIEN 3 resulted in lifetime costs per patient of 940,541 Swedish krona (SEK) and lifetime quality-adjusted life years (QALYs) per patient of 7.16, whilst SAVR resulted in lifetime costs and QALYs per patient of 821,380 SEK and 6.81 QALYs, respectively. Compared with SAVR, TAVI offered an incremental improvement of +0.35 QALY per patient at an increased cost of +119,161 SEK per patient over a lifetime horizon, resulting in an incremental cost-effectiveness ratio of 343,918 SEK per QALY gained. Conclusion: TAVI with SAPIEN 3 is a cost-effective option versus SAVR for patients with symptomatic severe aortic stenosis at low risk for surgical mortality treated in the Swedish healthcare setting. These findings may inform policy decisions in Sweden for the management of this patient group.

Three-Year Clinical and Hemodynamic Evaluation of the Hydra Self-Expanding Transcatheter Aortic Valve in Patients With Severe Aortic Stenosis.

The Hydra CE study revealed 1-year favorable efficacy of TAVR, showing a large effective orifice area (EOA), low gradient, and acceptable complication rates. We evaluated the 3-year clinical and hemodynamic outcomes of Hydra self-expanding transcatheter aortic valve (manufactured by Vascular Innovations Co Ltd, Nonthaburi, Thailand; a subsidiary of Sahajanand Medical Technologies Limited, India) in patients with symptomatic severe aortic stenosis at high or extremely high surgical risk. The Hydra CE study was a prospective, multicenter, single-arm study. A total of 157 patients were enrolled in the study, out of whom 54 patients from two centers (Lithuania and Poland) had provided consent for long-term follow-up at recruitment, with a planned 5-year follow-up period. The primary endpoint was all-cause mortality, and patients were followed up for up to 3 years, with an assessment of clinical and echocardiographic outcomes. Among the 54 patients, the average age was 81.0 ± 4.1 years. The mean STS score was 3.2 ± 2.0%. At 3 years, all-cause mortality had occurred in 14.8% of patients, including 3.7% cardiovascular deaths and 1.9% device-related deaths. There was a progressive enhancement in EOA that is, 0.68 ± 0.15 cm2 at baseline to 1.97 ± 0.52 cm2 at 3 years (p < 0.001) as well as significant improvement in the mean aortic valve gradient that is, 53.4 ± 14.24 mmHg at baseline to 8.6 ± 2.80 mmHg at 3 years (p < 0.001). New permanent pacemaker implantation rates up to 3-year follow-up was 12.9%. The 3-year results of the Hydra CE study demonstrated consistent improvements in hemodynamics over time. The study also revealed favorable safety and efficacy trends, along with low occurrences of new permanent pacemaker implantations and paravalvular leaks.

TRanscatheter Aortic-Valve Implantation with or without on-site Cardiac Surgery: the TRACS trial: TAVI in centers without on-site cardiac surgery

Transcatheter aortic valve implantation (TAVI) has emerged as an effective and safe treatment for patients with symptomatic aortic stenosis. The indication to TAVI should be agreed upon by a Heart Team, and the procedure should be performed in centers with on-site cardiac surgery. However, TAVI complications requiring emergent cardiac surgery (ECS) have become very rare. Concurrently, access disparities and prolonged waiting times are pressing issues due to increasing clinical demand of TAVI. Many solutions have been proposed and one of them is the possibility of performing TAVI in centers without on-site cardiac surgery. The TRanscatheter Aortic-Valve Implantation with or without on-site Cardiac Surgery (TRACS) trial is a prospective, randomized, multicenter, open-label study with blinded adjudicated evaluation of outcomes. Patients with symptomatic severe aortic stenosis and deemed inoperable, at high surgical risk, or presenting with at least one clinical factor compromising the benefit/risk ratio for ECS, will be randomized to undergo TAVI either in centers with or without on-site cardiac surgery. The primary endpoint will be the composite occurrence of all-cause death, stroke, and hospital readmission for cardiovascular causes at one year. The safety endpoint will include death attributable to periprocedural complications actionable by ECS. The study aims to enroll 566 patients. The TRACS trial aims to address critical gaps in knowledge regarding the safety and efficacy of TAVI procedures performed in centers without on-site cardiac surgery, potentially improving access and outcomes for high-risk patients. ClinicalTrials.gov NCT05751577.

Cardiopulmonary exercise testing in aortic stenosis patients before and after aortic valve replacement

BackgroundKnowledge about how patients with symptomatic aortic stenosis (AS) perform on cardiopulmonary exercise testing (CPET) is sparse. Since exercise testing in patients with symptomatic AS is not advised, submaximal parameters...

Effect of Valve Type and Anesthesia Strategy for TAVR: 5-YearResultsoftheSOLVE-TAVITrial.

In the randomized SOLVE-TAVI (compariSon of secOnd-generation seLf-expandable vs. balloon-expandable Valves and gEneral vs. local anesthesia in Transcatheter Aortic Valve Implantation) trial comparing newer-generation self-expanding valves (SEV) and balloon-expandable valves (BEV), as well as conscious sedation (CS) and general anesthesia (GA), clinical outcomes were similar both for valve and anesthesia comparison at 30days and 1 year. Prosthesis durability may affect clinical outcomes during long-term follow-up. Moreover, the impact of the anesthesia strategy on long-term clinical outcomes is unknown so far. The authors sought to compare clinical outcomes during 5-year follow-up in the randomized SOLVE-TAVI trial. In the randomized, multicenter, 2× 2 factorial, open-label SOLVE-TAVI trial, 447 intermediate- to high-risk patients with severe, symptomatic aortic stenosis were randomly assigned to transfemoral transcatheter aortic valve replacement (TAVR) using either SEV (Evolut R, Medtronic) or BEV (SAPIEN 3, Edwards Lifesciences) and also to CS vs GA. Patients were followed-up for 5 years. During 5 years of follow-up, the combined predefined endpoint of all-cause mortality, stroke, moderate or severe paravalvular leakage, and permanent pacemaker implantation was similar in the SEV and BEV groups (67.7% vs 63.4%; HR: 0.89; 95%CI: 0.70-1.13; P=0.34). Stroke rates at 5 years were lower in the SEV group (2.2% vs 9.6%; HR: 4.84; 95%CI: 1.65-14.18; P=0.002). Regarding the anesthesia comparison, the primary endpoint of all-cause mortality, stroke, myocardial infarction, and acute kidney injury occurred in 51.4% in the CS group and 61.3% in the GA group (HR: 0.80; 95%CI: 0.62-1.04; P=0.09). All-cause mortality at 5 years was lower for CS (41.5% vs 54.3%; HR: 0.70; 95%CI: 0.53-0.94; P=0.02). Transfemoral TAVR using either SEV and BEV as well as CS and GA showed similar clinical outcomes at 5 years using a combined clinical endpoint.

TAVIGER : Intérêt d’une expertise coordonnée gériatrique et cardiologique dans le bilan d’éligibilité des patients âgés à un remplacement valvulaire aortique par voie percutanée

BackgroundTranscatheter aortic valve implantation (TAVI) is the gold standard treatment for aortic stenosis in the elderly. Pre-identification of patients likely to benefit from this procedure remains crucial. A standardised geriatric assessment is used to identify the major geriatric syndromes likely to influence postoperative outcomes. ObjectiveTo identify factors associated with lack of TAVI management and to compare one-year survival in TAVI vs. non-TAVI patients. MethodsRetrospective study, between 2016 and 2020, at the Arras hospital. Patients aged 70 years and older with symptomatic severe aortic stenosis who had undergone geriatric assessment were included. ResultsOne hundred and ninety-two (192) patients, mean age 82.3 years. The 1-year mortality rate was 18% in the TAVI group and 44% in the non-TAVI group (p < 0.001).Parameters associated with no TAVI were Euroscore (ESL) 1 (19.6 ± 10.9 vs. 23.2 ± 13.5, p = 0.020), malnutrition (14% vs. 35%, p = 0.004), walking speed < 0.8 m/s (39% vs. 75%, p = 0.001), Activities of Daily Life (ADL) score (5.4 ± 1 vs. 4.2 ± 1. 6, p < 0. 001) and Instrumental Activities of Daily Life (IADL) score (2.6 ± 1.2 vs. 1.8 ± 1.4, p = 0.002), Mini Geriatric Depression Scale (mini GDS) ≥ 1 (16% vs. 38%, p = 0.045), Mini Mental State Examination (MMSE) score (25.1 ± 3.5 vs. 21.6 ± 4.3 < 0.001). ConclusionsGeriatric syndromes are important determinants of TAVI candidacy. Cardiological surgical risk scores are not effective in discriminating between patients. Coordinated assessment may optimise selection. Therefore, geriatric assessment should be systematically performed as part of the pre-TAVI evaluation.

Cerebral Embolic Protection by Geographic Region

Transcatheter aortic valve replacement (TAVR) is an established treatment option for many patients with severe symptomatic aortic stenosis; however, debris dislodged during the procedure can cause embolic stroke. The Sentinel cerebral embolic protection (CEP) device is approved for capture and removal of embolic material during TAVR but its efficacy has been debated. To explore regional differences in the association of CEP utilization with stroke outcomes in patients undergoing TAVR. This post hoc analysis of a prospective, postmarket, randomized clinical trial evaluating TAVR performed with or without the CEP took place at 51 hospitals in the US, Europe, and Australia from February 2020 to January 2022. Patients with symptomatic aortic stenosis treated with transfemoral TAVR were included. Randomization was stratified according to center, operative risk, and intended TAVR valve type. Patients were excluded if the left common carotid or brachiocephalic artery had greater than 70% stenosis or if the anatomy precluded placement of the CEP device. Data for this post hoc study were analyzed from August to October 2024. TAVR with or without CEP. The primary end point was the rate of all stroke events at hospital discharge or 72 hours post-TAVR, whichever came first. Neurological examinations were performed at baseline and postprocedure to identify stroke, disabling stroke, and other neurological outcomes. The Stroke Protection With Sentinel During Transcatheter Aortic Valve Replacement (PROTECTED TAVR) trial enrolled and randomized 3000 patients (1803 [60.1%] male; mean [SD] age, 78.9 [7.8] years): 1833 in the US cohort (TAVR alone: 919, TAVR with CEP: 914) and 1167 patients in the outside the US (OUS) cohort (TAVR alone: 580, TAVR with CEP: 587). Patients in the US cohort were younger, more predominantly male, had a lower prevalence of atrial fibrillation, and had a higher prevalence of bicuspid aortic valve, diabetes, and peripheral vascular disease compared with the OUS cohort. In the main trial, the incidence of stroke within 72 hours after TAVR or before discharge did not differ significantly between the CEP group and the control group, and there was no interaction by geographic region. In this post hoc analysis, patients treated with CEP in the US cohort exhibited a 50% relative risk reduction for overall stroke and a 73% relative risk reduction for disabling stroke compared to TAVR alone; a treatment effect on stroke risk reduction was not observed in the OUS cohort. The PROTECTED TAVR trial could not show that the use of CEP had a significant effect on the incidence of periprocedural stroke during TAVR. Although there was no significant interaction by geographic region, this exploratory post hoc analysis suggests a trend toward greater stroke reduction in the US cohort but not in the OUS cohort. These findings are hypothesis generating, and further research is needed to determine if regional differences in patient characteristics or procedural practices affect CEP efficacy. ClinicalTrials.gov Identifier: NCT04149535.

Left ventricular mass index and prognosis of symptomatic severe aortic stenosis in women and men

Abstract Background Symptomatic severe aortic stenosis (AS) requires surgical (SAVR) or transcatheter aortic valve replacement (TAVR), and many patients are on the procedure waiting list. The diagnosis of severe AS is based on clinical and echocardiographic criteria, such as left ventricular ejection fraction (LVEF), aortic valve area (AVA), mean transvalvular gradient, and peak aortic jet velocity. However, there is a gap in knowledge regarding the influence of left ventricular mass on the prognosis of these patients, especially considering differences between women and men. Purpose To evaluate the influence of left ventricular mass index (LVMi) on the mortality of women and men with severe AS awaiting SAVR or TAVR. Methods A prospective study analysed the death rate in 531 outpatients with symptomatic severe AS with mean transvalvular gradient ≥40 mmHg, AVA ≤1.0 cm2, or peak aortic jet velocity ≥4.0m/s at echocardiography with the indication for TAVR or SAVR in the period from April 2020 to February 2024. Baseline data included analysis of clinical characteristics, echocardiographic variables, and the presence of coronary artery disease (CAD). Statistical analyses were performed using the Kaplan-Meier (K-M) and Cox proportional hazards methods to analyze mortality rates in women and men. Results The mean age was 74.7±11.6 years, with 283 (53.3%) men. Over a follow-up period of 2.67±1.22 years, death occurred in 165 (31.1%), 148 (86%) due to cardiovascular disease, and 152 (92%) had heart failure (HF) NYHA II to IV, 51 (9,6%) had angina, and syncope in 11 (2.1%) of the patients. Patients who died had lower LVEF (61.4%±8.9% vs. 58.8%±10.8%; p=0.008) and higher LVMi (125.3±32.5 g/m2 vs. 115.5±29.3 g/m2; p=0.001). Angina, syncope, hypertension, dyslipidemia, diabetes, smoking, atrial fibrillation, and CAD prevalence were similar in living patients and in those who died. Both groups had similar echocardiographic data, such as left atrial volume, mean transvalvular gradient, and peak jet velocity. TAVR and SAVR were done in 111 (20.9%) and 162 (30.5%) patients. Of these, 21 (18.9%) and 20 (12.4%) died during follow-up, respectively. Cumulative mortality of all patients was higher with LVMi &amp;gt;115 g/m2 compared to ≤115 g/m2 (p=0.008)(Figure). In women but not in men, cumulative mortality was higher with LVMi &amp;gt;115 g/m2 compared to ≤115 g/m2 (p=0.046). Cox multivariate analysis, adjusted for LVEF, LVMi, CAD, and age, showed LVMi as an independent variable for death [HR=1.50 (95%CI: 1.10-2.05); p=0.011]. LVEF [HR=0.97 (95%CI: 0.95-0.99); p=0.009] and LVMi [HR=1.75 (95%CI: 1.10-2.79); p=0.016] were independent variables for death in women, but not in men. Conclusion Women with higher LVMi and lower LVEF should have valve intervention prioritized.Figure

Identification of new instances of white matter hyperintensities in patients following TAVI (from the CAPITA study)

Abstract A third of patients diagnosed with symptomatic severe aortic valve stenosis and scheduled for transcatheter aortic valve implantation (TAVI) exhibit some level of cognitive impairment. The prospective CAPITA study aimed to systematically evaluate the impact of TAVI on cerebral and cognitive outcomes in patients undergoing the procedure. In this report, we focus on the identification of new incidence of white matter hyperintensities (WMH) and the correlation with changes in cognitive functioning. The CAPITA (CArdiac OutPut, Cerebral Blood Flow and Cognition In Patients With Severe Aortic Valve Stenosis Undergoing Transcatheter Aortic Valve Implantation) study is a prospective study of cerebral and cognitive outcomes following TAVI. Patients underwent magnetic resonance imaging (MRI) and extensive neuropsychological testing at baseline and three month follow-up. New cerebral infarcts were defined according to NeuroARC criteria. We examined the incidence of new WMH in terms of volume (Δ mL) and number on FLAIR MRI, and explored the correlation between new WMH and cognitive functioning. A total of 148 patients were included who underwent TAVI between August 2020 and October 2022. Mean age was 80.5±5.7 years, of whom 43% female with a median STS-PROM of 2.0% (IQR 1.4%-2.9%). Median baseline WMH comprised 127 (IQR 32-216) lesions, with a total volume of 13.1 (IQR 7.0-24.6) mL. At 3 months follow-up, the number of lesions increased to 164 (IQR 121-301) lesions, with a total volume of 13.3 (IQR 5.8-21.5) mL. Median WMH volume increase was 0.1 (IQR 0.0-0.3) ml (p=0.02). A total of 9 patients (9.5%) had an increase of 1 mL of WMH or more. At follow-up, 12% of patients exhibited cognitive decline of &amp;gt;0.5SD. These patient tended to have a greater increase in white matter hyperintensity volume (1.26±2.96 ml), compared to the 53% of patients with stable cognition (0.29±0.45 ml) and the 36% of patients with improved cognition (0.31±0.91 ml), (p=0.06). WMH lesions did not exhibit distribution patterns across various locations within the groups characterized by declined, stable, or improved cognition (Figure 1). WMH volumes were higher in patients who experienced postprocedural delirium than in patients without delirium (27.1±14.0 vs 15.0±12.5 mL, p&amp;lt;0.001). In this study, patients with severe symptomatic aortic valve stenosis undergoing TAVI, there was an overall increase of white matter hyperintensity volume between baseline and 3-month follow-up. Up to 12% of patients had cognitive decline, which was associated with new white matter hyperintensities on MRI.

Discordance between symptomatic response and changes in cardiac structure and function one year after transcatheter aortic valve implantation

Abstract Background Symptomatic improvement is one of the main goals of transcatheter aortic valve implantation (TAVI) in patients with severe symptomatic aortic stenosis. We hypothesized that the degree of symptomatic response after TAVI is associated with improvement in cardiac structure and function after TAVI. Purpose We aimed to evaluate 1) the change in symptomatic burden measured by New York Heart Association (NYHA) and Canadian Cardiovascular Society (CCS) functional class after TAVI, 2) the change in echocardiographic structural and functional parameters after TAVI, and 3) the association of symptomatic response with echocardiographic response as well as long-term survival. Methods In patients undergoing TAVI, we assessed New York Heart Association (NYHA) and Canadian Cardiovascular Society (CCS) functional class at 12 months. Symptomatic response was defined as NYHA/CCS class I or ≥ 1 improvement in NYHA/CCS class compared to baseline at 12 months. Echocardiographic images at baseline and 6-18 months post-TAVI were analysed using an automated, validated, deep-learning workflow. Logistic regression was used to assess association between change in echocardiographic parameters and symptomatic change at 12 months. The association of symptomatic response and echocardiographic changes in the first 12 months after TAVI with survival beyond 12 months, was evaluated by landmark analysis using Kaplan-Meier analysis. Results Among 868 TAVI patients (median age 80 years, 53% female), the majority (74%) had NYHA/CCS class III at baseline and 77% of patients experienced improvement in symptoms at 12 months post-TAVI (Figure 1). Patients without an improvement in symptoms more often had COPD, atrial fibrillation and more heart failure medications compared to responders. Left ventricular systolic function did not show improvement compared to baseline, whereas a modest improvement in left atrial volume index, left ventricular mass index, E/A ratio, E/e’ ratio, mean e’ and tricuspid regurgitation peak jet velocity was observed. Symptomatic response was not associated with echocardiographic response. Beyond 12 months, patients with symptomatic improvement had lower mortality than those without symptomatic improvement (1.5 vs. 2.4 per 10 patient years; p = .001), whereas changes in echocardiographic parameters were not associated with subsequent mortality (Figure 2). Conclusion Patients undergoing TAVI for symptomatic severe aortic stenosis, showed substantial symptomatic improvement at one year after the procedure, whereas only a modest improvement in echocardiographic parameters was observed. Improvement in symptoms was not associated with improvement in echocardiographic measures of cardiac structure and function. Symptomatic improvement, but not improvement in cardiac structure and function at 12 months, was a strong predictor of subsequent survival.Change in NYHA/CCS class after TAVISymptoms and echo versus mortality

5-year valve academic research consortium-3 outcomes and predictors of mortality in a 10-year Asian transcatheter aortic valve implantation registry

Abstract Background Transaortic valvular implantation (TAVI) has revolutionised the management of aortic stenosis (AS). Uptake in Asia has caught up in recent years, after an initial lag due to expensive cost, limited subsidies, and scarce accessibility. Hence, longitudinal outcomes of TAVI remain largely unknown in Asian patients. Purpose This study aims to present the 5-year mortality endpoints in an Asian cohort followed up over a decade. Methods 253 patients with symptomatic severe aortic stenosis status post TAVI were retrospectively enrolled at a tertiary academic hospital from 2010-2021. The main outcomes were defined as short-term (30-day), mid-term (1-year) and long-term (5-year) all-cause mortality. Baseline demographics, procedural findings and clinical outcomes were analysed. Kaplan-Meier curves and multiple Cox regression analyses were constructed. Results The mean age was 75.2 + 10.2 years. 120 (47.4%) patients were female and 167 (66%) were Chinese. 168 patients (66.7%) received balloon-expandable valves, 80 patients (31.7%) underwent self-expandable valves, and 4 patients (1.6%) had mechanical-expandable valves. Malignancy was associated with worse short-term mortality at 30-days (HR 3.65, p = 0.054), while pulmonary disease and previous stroke were associated with worse long-term mortality at 5-years (HR 2.27, p = 0.012 and HR 2.02, p = 0.064). Worse all-cause mortality at 30-days, 1-year and 5-years were associated with high NT-Pro BNP levels (HR 1.04, p = 0.046; HR 1.05, p = 0.002 and HR 1.04, p &amp;lt; 0.001), the presence of peripheral arterial disease (PAD) (HR 4.32, p = 0.056; HR 4.48, p = 0.006 and HR 2.43, p = 0.023) and chronic kidney disease (CKD) (HR 6.19, p = 0.006; HR 6.77, p &amp;lt; 0.001 and HR 2.09, p = 0.008). Society of Thoracic Surgery (STS) score (HR 1.11, p = 0.001; HR 1.13, p &amp;lt; 0.001 and HR 1.12, p &amp;lt; 0.001) and Valve Academic Research Consortium (VARC) III endpoints of acute kidney injury (AKI) (HR 6.68, p = 0.047, HR 10.8, p &amp;lt; 0.001 and HR 6.99, p &amp;lt; 0.001), cardiogenic shock (HR 26.3, p &amp;lt; 0.001, HR 12.0, p &amp;lt; 0.001 and HR 4.29, p = 0.011) and structural complications (HR 40.3, p &amp;lt; 0.001, HR 18.1, p &amp;lt; 0.001 and HR 5.18, p = 0.008) were associated with worse all –cause mortality at time-points of 30-days, 1-year and 5-years respectively. On multivariate analyses adjusted for comorbidities and outcomes, STS score and structural complications were independent predictors of 30-day, 1-year, and 5-year all-cause mortality (HR 1.16; p = 0.003, HR 1.09, p = 0.003 and HR 1.10, p &amp;lt; 0.001) and (HR 62.7, p &amp;lt; 0.007; HR 18.9, p &amp;lt; 0.001 and HR 10.6, p = 0.001) respectively. Angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor blocker (ARB) use was protective of survival within 1-year (HR 0.37, p = 0.022). Conclusions STS score and VARC III endpoints of structural complications were reliable predictors of all-cause mortality in Asian patients with TAVI. ACE inhibitor and ARB use was protective against mortality at 1-year.Cox regression analysesKaplan-Meier curves

Impact of SAPIEN3 Ultra RESILIA on improvement of valve performance: Insights from the multicenter registry: a propensity-score matched analysis

Abstract Backgrounds: Transcatheter aortic valve implantation (TAVI) is now a cornerstone treatment for symptomatic severe aortic stenosis across all risk profiles, including low-risk and younger patients. As such, the performance and durability of transcatheter heart valves (THVs) are paramount. SAPIEN3 Ultra RESILIA (S3 UR) is expected to improve hemodynamics compared with SAPIEN3 (S3) due to the use of RESILIA bovine pericardial tissue and modified sawing maneuvers for each of three leaflets in 20 and 23mm valves. Aim The aim of study was to evaluate the hemodynamic improvement with S3 UR compared to S3 who underwent TAVI. Methods In a multicenter TAVI registry, we identified 1,931 patients who received a balloon-expandable valve over the past three years. We focused on post-procedural effective orifice area (EOA), post-procedural indexed EOA (EOAi), incidence of prosthesis-patient mismatch (PPM), paravalvular leakage (PVL) and post-procedural mean pressure gradient (mean PG) as our primary endpoints. We preformed propensity score matching analysis using a 1:1 ratio. Parameters including aortic stenosis severity, % oversizing and post dilatation were incorporated into the matching model. Results Of patients, mean age was 84 years old and 37.9% were male. EOAi was significantly larger in S3 UR group than in the S3 group for both cohorts [overall cohort: 1.21 (1.02 – 1.36) vs. 1.08 (0.93 – 1.26), P = 0.001; propensity matched cohort: 1.21 (1.01 – 1.35) vs. 1.11 (0.91 – 1.27), p = 0.042, respectively] (Figure 1). Similarly, the degree of PVL was significantly less in the S3 UR group than in the S3 group for both cohorts. In the propensity matched cohort, mild PVL was identified in 6.5% vs. 14.7%, and moderate PVL was present in 0.0% vs. 1.6% (p = 0.028). Peak PG and mean PG were significantly lower in the S3 UR group than in the S3 group for both cohorts. In the propensity matched cohort, peak PG was 17.7 (14.3 – 24.5) vs. 23.2 (18.2 – 29.2) (p = 0.001) and mean PG was 9.0 (7.1 – 12.5) vs. 11.5 (8.9 -14.8) (p = 0.005), respectively. The incidence of PVL ≥ mild, mean PG ≥ 20 mmHg, moderate PPM and severe PPM were tend to be lower in S3 UR group than in the S3 group for both cohorts (Figure 2). Conclusion The S3 UR valve exhibits significant hemodynamic improvements compared to the S3 valve, underscoring its potential for improved clinical outcomes in TAVI patients.

Fully automated CT analysis with a deep-learning based algorithm for pre-procedural planning in transcatheter aortic valve implantation

Abstract Background Pre-procedural cardiac computed tomography analysis has emerged to an essential tool in transcatheter aortic valve implantation (TAVI). It facilitates the valve choice and allows for optimal vascular access planning. For this purpose, software programs have been specifically developed to assist a fast and precise analysis of the generated data set in high quality. However, these software programs only assist the evaluator and are not able to perform a complete analysis on their own. Purpose We report the performance of a fully-automated, deep-learning based algorithm for pre-procedural CT analysis as compared to the current clinical standard. Methods Ninety-eight patients with symptomatic severe aortic stenosis undergoing TAVI were retrospectively enrolled. The pre-procedural data set was analyzed in two ways: - conventionally with a commercially available TAVI CT-analysis software by experiences users . - by a fully-automated CT-analysis platform with a deep-learning based algorithm. The current beta-version of the platform allows the determination of the annulus diameter, -area, -perimeter and the distance measurements of the coronary arteries to the aortic annulus. Hence, analyzable parameters were limited to the aforementioned, to ensure comparability. Statistical analysis: Mean, standard deviation, mean of difference and the interclass-correlation coefficient (ICC) were calculated and Bland-Altman plots created. Results The mean annulus diameter was 24.5±2.5mm (conventional) vs. 24.1±2.4 mm (deep learning). The mean of difference was 0.42±0.82mm (Bland-Altmann diagram. Figure 1). The ICC was 0.964 (0.925; 0.980), showing an excellent correlation between the two values. The mean annulus perimeter was 77.7±7.4mm (conventional) vs. 75.6±9.3mm (deep learning), showing a very good correlation of the means [mean of difference: 2.11±5.75mm; ICC: 0.852 (0.759; 0.906)]. The distance from the annulus to the left coronary artery was 14.0±3.2mm (conventional) vs. 12.6±2.8mm (deep learning). We depicted a good correlation between the two values [mean of difference: 1.45±2.52mm; ICC 0.736 (IQR 0.483; 0.850)]. The distance from the annulus to the right coronary artery was 17.1±2.7mm (conventional) vs. 16.5±3.2mm (deep learning), respectively. A very good correlation between the two values could be shown [mean of difference 0.57±2.2mm; ICC 0.822 (0.730; 0.882)], as well. Additionally, both methods visualize the measurements and allow manual adjustments (Figure 2). Conclusion In this retrospective analysis, deep-learning based analysis of peri-procedural derived CT data sets showed an very good correlation with conventional assessment. If results can be sustained in a bigger patient cohort and extended to more complex measurements, this artificial intelligence based fully-automated CT-analysis could emerge to a valuable alternative to conventional CT assessment in the pre-procedural planning for TAVI.Figure 1 - Bland-Altman plotFigure 2- Measurements by both methods

Clinical impact of transcatheter aortic valve implantation (TAVI) in frail patients: a single-center prospective study

Abstract Introduction Transcatheter aortic valve implantation (TAVI) stands as an effective treatment option for symptomatic severe aortic stenosis, applicable across all surgical risk spectrum. Registries show that up to 60% of these patients exhibit at least one marker of frailty. Frailty has been associated with higher 1-year mortality rates and heightened susceptibility to complications. Conservative treatment, however, has a poor prognosis, with mortality ranging from 30-60% within a year after diagnosis. Objective The primary objective was to assess the clinical impact of TAVI implantation in the frail population. A secondary objective was to assess the occurrence of in-hospital and short-term (30 days) complications. Methods Observational, prospective, single-center study that included all patients with TAVI implantation in our unit in 2023. Frailty was assessed by an interventional cardiologist according to the Rockwood Clinical Frailty Scale (CFS) or Frailty Scale, assigning a score from 1 to 9, with patients being classified as high CFS if they scored ≥5 points or low CFS if &amp;lt;5 points. Results Out of the 298 patients included, 45 (15%) had high CFS vs 253 (85%) with low CFS. Significant differences were found in age (83.3±5.3 years for high CFS vs 79.4±5.8 years for low CFS;p&amp;lt;0.01), gender (60% of females for high CFS vs 43.9% for low CFS;p=0.046) and baseline haemoglobin (12.2±1.5 g/dL for high CFS vs 12.9±1.8 g/dL for low CFS;p=0.008). Other baseline characteristics remained comparable. Patients with high CFS had greater baseline dyspnoea according to the YHA scale (NYHA III-IV 71.1% for high CFS vs 37.9% for low CFS;p&amp;lt;0.001) with greater diuretic use (71.1% for high CFS vs 51% for low CFS;p=0.013). Patients with high CFS had a greater need for a preferential/urgent procedure (p=0.044). There were no differences in the occurrence of complications: stroke (p=0.463), bleeding (p=0.667), vascular complications (p=0.234); except for a higher occurrence of complete AV block (22.3% for high CFS vs 8.7% for low CFS;p=0.024). In-hospital mortality rates showed no differences (0% for high CFS vs 1.6% for low CFS;p=0.396). At 1-month follow-up, there was a significant reduction in NYHA dyspnoea grade within the high CFS group (71.1% NYHA III-IV pre-TAVI vs 2.3% post-TAVI; p&amp;lt;0.001). There was no difference in the incidence of stroke (p=0.375), heart failure readmissions (p=0.734), and vascular complications (p=0.66). There was no difference in all-cause mortality (4.4% for high CFS vs 3.2% for low CFS;p=0.675). Conclusions Highly frail patients undergoing TAVI experience a significant enhancement in functional class compared to their less frail counterparts. While short-term complications parallel those observed in less frail individuals, there is a slightly elevated incidence of pacemaker requirements in this group.NYHA Frail pre and post TAVIComplications

Multidomain cognitive improvement in patients with severe aortic valve stenosis undergoing transcatheter aortic valve implantation

Abstract Background Cognitive impairment is prevalent in one third of patients with symptomatic severe aortic valve stenosis scheduled for transcatheter aortic valve implantation (TAVI). How TAVI affects cognitive functioning in these patients remains unknown. Purpose The CAPITA study (CArdiac outPut, cerebral blood flow and cognition In patients with severe aortic valve stenosis undergoing Transcatheter Aortic valve implantation) assessed the effects of TAVI on cerebral lesions and cognitive functioning. Methods CAPITA is a prospective study of cerebral and cognitive outcomes in 148 patients undergoing TAVI. One day before and three months after TAVI, patients underwent a standardized multidomain neuropsychological assessment, and simultaneous brain magnetic resonance imaging. The primary outcome was change in global cognitive functioning as measured with z-scores. Also, we assessed the cognitive subdomains of attention/psychomotor speed, memory, language, and executive functioning. Z-scores for each cognitive domain were constructed as: (test score - mean baseline score) / standard deviation. Global cognitive function was calculated as the mean from the four domain scores. Results Mean age was 80.5±5.7 years, 43% was female and median STS-PROM (Society for Thoracic Surgeons Predicted Risk for 30-day Mortality) was 2.0% (IQR 1.4%-2.9%). MoCA scores improved from 23.3±3.7 to 24.4±3.3, (p&amp;lt;0.001) and MMSE scores from 26.4±2.6 to 26.9±2.4 (p=0.01). There was an overall increase in global cognitive z-scores (0.02±0.52 to 0.15±0.48, p&amp;lt;0.001). Cognitive domains of memory (0.03±0.77 to 0.18±0.80, p=0.003) and language (-0.07±1.07 to 0.20±0.80, p=0.02) significantly improved, whereas executive function (0.01±0.70 to 0.06±0.76, p=0.42) and attention (0.10±0.69 to 0.17±0.69, p=0.06) did not significantly change. Quality of life on the visual analogue scale improved from 66.4±15.9 to 72.9±12.8, (p&amp;lt;0.001). Patients in the lowest tertile of baseline cognitive functioning (i.e., those with worst baseline cognitive functioning), had the largest increase in cognitive functioning, compared with patients in the intermediate or highest tertile of baseline cognitive functioning (0.30±0.55 vs 0.09±0.27 vs 0.01±0.16, p=0.002). Patients with &amp;gt;0.5 SD decline in cognitive functioning (12%), had a higher volume of new white matter hyperintensities on follow-up MRI than patients with stable or improved cognitive functioning (1.26±2.96, vs 0.29±0.45 vs 0.31±0.91 mL, p=0.06). Conclusions In 148 patients who underwent TAVI, there was an overall improvement in cognitive functioning at three months follow-up. This improvement was consistent through different cognitive domains and most prominent in patient with lowest baseline cognitive functioning.Change in cognitive functionin

Comparison of mortality scores performance in transcatheter aortic valve replacement: suiting up to percutaneous intervention

Abstract Introduction As transcatheter aortic valve replacement (TAVR) is increasingly relevant for patients with severe symptomatic aortic stenosis, having a reliable procedure specific risk-prediction tool is paramount to provide high-quality care. Surgical scores as the EuroScore II and the Society of Thoracic Surgeons (STS) score II have been widely used to identify patients with high surgical risk in whom percutaneous treatment might be more favorable. However, current literature lacks a consensual specific predictive model for short-term and mid-term prognosis in patients undergoing transcatheter aortic valve implantation (TAVI). Purpose We aimed to access short and midterm (30 days and one year) mortality and to access the ability of a directly adapted score in estimating mortality in a real-world population. Methods We conducted a retrospective observational study in patients who implanted TAVR in a single center. Surgical mortality scores – EUROSCORE II and STS score II – and adapted score Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) transcatheter valve therapy (TVT) score were used to estimate mortality. Predictive abilities of these three scores were compared using area under the receiver operating characteristics (ROC) curve for 30-day and one year mortality. Results From January 2018 to December 2021, 416 patients were submitted to TAVR procedure in our center. The mean age was 83+-6 years old and 229 (55%) were female. 94% had hypertension, 80% dyslipidemia, 40% diabetes mellitus, 35% coronary artery disease, 32% chronic kidney disease. Mean ejection fraction was 56%. During a mean follow-up (FUP) of 816 ± 492 days, 30-day mortality was 1,7% and after 1 year mortality rate was 12,2% (higher than reported in PARTNER 3 trial, 8,5%). The Mean EuroSCORE was 3,4±3,2, mean STS-II 3,9±1,8 and mean value for STS/ACC-TVT score was 3,55±1,34. ROC curve analysis showed a significantly higher discriminative power of STS/ACC-TVT (AUC 0,749, 95% CI 0,681-0,818) compared with surgical scores (p=0,001) – figure 1. We also divided population into quartiles and compared the mortality rate at 30 days and 1 year in each quartile using either STSII or STS/ACC-TVT; As can be seen in figure 2, mortality rates correlated better with the STS/ACC-TVT score than with the STS score. Conclusion A score adapted to a TAVI population showed better predictive capacity than traditional surgical scores. Less preponderance of previous surgical status, relevance of access site and more adapted weight of age might explain the best performance of STS/ACC-TVT score. Surgical scores are helpful in choosing treatment option, but adapted scores are better to predict pos-TAVR mortality.

A new wearable cardiac acoustic monitoring technology for the evaluation of subclinical leaflet thrombosis after transcatheter aortic valve replacement: a pilot study

Abstract Background Subclinical leaflet thrombosis characterized by hypoattenuated leaflet thickening (HALT) and reduced leaflet motion (RLM) is a common complication after transcatheter aortic valve replacement (TAVR), whether it affects hemodynamic change is still debated. Purpose We attempted to use a novel wearable heart acoustic monitoring device, and combined multi-dimensional computed tomography (MDCT) and echocardiography to diagnose SLT and analyze the changes of transvalvular hemodynamics after TAVR. Methods Patients with severe symptomatic aortic stenosis and underwent successful TAVR were consecutively enrolled. Clinical data, acoustic cardiographic parameters including the frequency, amplitude, and energy of heart sounds , and imaging results were collected and analyzed by Core laboratory at pre- and post TAVR, and follow-up at one month and six month. According to severity of SLT at one month follow-up, we divided the patients into three groups: Group1: no SLT, Group2: mild SLT, defined as existed HALT did not qualify for Group 3, and Group 3: moderate to severe SLT, defined as at least 1 leaflet with HALT of grade 3 or 4 or RLM of ≥50%, or 2 leaflets with HALT of grade 2 or RLM of ≥50%. A consistency analysis of SLT presence between MDCT findings and acoustic cardiographic variables was performed using Kappa statistics. Results The study included 116 TAVR patients. The prevalence of SLT as detected by MDCT at one-month follow-up was 25%, with moderate to severe SLT representing 11.2% of cases. A significant decrease in aortic valve orifice area (AVA) (-0.2±0.48cm2 vs. -0.1±0.33cm2, p=0.009) and an increase in mean gradient (MG) (3.5±5.85 mmHg vs. 0.1±11.34mmHg, p=0.028) were observed in moderate to severe SLT group at one-month follow-up versus post-TAVR via echocardiography. However, no significant differences were found in the mild SLT or no SLT group. Acoustic cardiographic characteristics exhibited a distinct pattern with early systolic, baseless, and high-energy murmurs in patients with moderate to severe SLT, but not in the mild SLT or no SLT group. The sensitivity, specificity, and Kappa values for acoustic cardiography in diagnosing moderate to severe SLT were 81.82%, 83.33%, and 0.41, respectively. At the 6-month follow-up, MDCT showed that 11 (85%) patients with moderate to severe SLT who received anticoagulant therapy reached complete dissolution of SLT. Conclusion Moderate to severe SLT presented notably transvalvular hemodynamic influences following TAVR. Acoustic cardiography demonstrated specific characteristics of moderate to severe SLT, providing a valuable tool for SLT diagnosis and evaluation in clinical follow-up.Figure 1.Baseline characteristicsFigure 2.SLT and acoustic cardiography

LV reverse remodeling after SAVR in patients with severe symptomatic aortic stenosis: impact on the clinical outcome

Abstract Introduction Surgical aortic valve replacement (SAVR) is the treatment of choice for young patients with severe aortic stenosis (AS) and low surgical risk. Left ventricular (LV) reverse remodeling (RR) after surgery is expected to occur. However, this is not always the case following afterload relief, and this may impact the prognosis. We aimed to assess the prognostic effect of distinct definitions of LV RR after SAVR in the long-term outcome of patients with severe AS. Methods Single-centre prospective study including patients referred for SAVR due to severe symptomatic AS, with no previous history of ischemic cardiomyopathy. Both pre- and post-operative transthoracic echocardiographic (TTE) and cardiac magnetic resonance (CMR) study (at the 3rd to 6th month after SAVR) were performed. LV RR was defined when in presence of at least one of the imaging criteria: &amp;gt;15% decrease in end-diastolic volume (EDV) by CMR; &amp;gt;15% decrease in LV indexed mass (LVM) by CMR; &amp;gt;10% decrease in geometric remodeling (LV mass/EDV ratio) by CMR; &amp;gt;10% increase in LV ejection fraction (LVEF) by CMR; &amp;gt;50% increase on global longitudinal strain (GLS) by TTE. We assess the prognostic value of RR definitions for the outcome after SAVR using Cox regression and Kaplan-Meier analysis. The primary endpoint was defined as all-cause mortality, heart failure (HF) hospitalization or worsening HF. Results We enrolled 140 patients – mean age 71±9 years-old, 49% male, predominantly high-gradient-normal flow AS (mean gradient 65±18mmHg, aortic valve area 0.7±0.2cm2, index stroke volume 47±11mL/m2) submitted to SAVR. At a mean follow-up (FUP) of 34±12 months, 23 (16%) patients met the primary endpoint: 4% (5 patients) died immediately after surgery; three patients died at the FUP (overall mortality rate of 6%). 12 patients (9%) were admitted for HF and 7 (5%) had at least one episode of worsening HF. 118 patients had complete pre and post-surgery imaging study (mean FUP: 36±10 months): 103 patients (87%) had at least one RR parameter (Table 1). Post-operative RR was not independently associated with the clinical outcome (Figure 1A). LVM was the sole independent predictor of the outcome at univariate analysis (Figure 1B–F). Conclusions LV RR after SAVR is highly prevalent in a cohort of patients with classical severe symptomatic AS. However, only LVM regression independently predicts the clinical outcome after surgery. This may stand the greater importance of structural reverse remodeling, rather than LV functional improvement, after pressure overload relief.

Prognostic utility of mid-regional pro-adrenomedullin and growth differentiation factor 15 in patients undergoing transfemoral transcatheter aortic valve implantation.

Risk prediction in patients with severe, symptomatic aortic stenosis (AS) undergoing transcatheter aortic valve implantation (TAVI) remains an unsolved issue. In addition to classical risk scoring systems, novel circulating biomarkers like mid-regional pro-adrenomedullin (MR-proADM) and growth differentiation factor 15 (GDF-15) may be of value in assessing risk. Consecutive patients undergoing elective transfemoral TAVI were included in this prospective observational study. Baseline information, imaging findings, blood samples, and clinical outcomes were collected. Blood levels of the classical biomarkers interleukin-6 (IL-6) and high-sensitivity C-reactive peptide (hsCRP) and of the novel biomarkers MR-proADM and GDF-15 were measured and their predictive utility for mortality assessed. The study cohort consisted of 92 patients undergoing TAVI. The median age was 80.7years [IQR 77.2;83.3], and 48 (52.2%) were male. Analysis of the area under the curve (AUC) of the receiver-operating characteristics showed that the hsCRP levels discriminated poorly (AUC 0.66, 95% CI [0.52;0.8], p = 0.027), whereas all other biomarkers reached a higher level of discrimination (IL-6: AUC 0.76, 95% CI [0.66;0.86], p < 0.001; MR-proADM: AUC 0.73, 95% CI [0.61;0.85], p = 0.002; GDF-15: AUC 0.73, 95% CI [0.61;0.85], p = 0.002). Kaplan-Meier analysis in conjunction with Youden J-statistics yielded the optimal cutoff points for each biomarker to predict survival: IL-6 4.65pg/mL, hsCRP 12.9mg/L, MR-proADM 1.02nmol/L, and GDF-15 2400.1pg/mL. Novel circulating biomarkers like MR-proADM and GDF-15 may provide additional value in predicting survival after TAVI.

Transcatheter aortic valve implantation with SAPIEN 3 versus surgical aortic valve replacement in patients with symptomatic severe aortic stenosis at low risk of surgical mortality: a cost-utility analysis for Switzerland.

The 2021 European Society of Cardiology Guidelines on valvular heart disease recommend transcatheter aortic valve implantation (TAVI) for patients with symptomatic severe aortic stenosis at low surgical risk and age ≥75 years who are suitable for a transfemoral approach (recommendation class IA) based on two large randomised controlled trials (PARTNER 3 and Evolut Low Risk) comparing transcatheter aortic valve implantation with surgical aortic valve replacement (SAVR). Whether such an approach is cost-effective in Switzerland remains unclear. The aim of this cost-utility analysis was to compare transcatheter aortic valve implantation with SAPIEN 3 versus surgical aortic valve replacement in symptomatic severe aortic stenosis patients at low risk of surgical mortality from the perspective of Swiss compulsory health insurance using data from the PARTNER 3 trial (reflecting specifically the safety and efficacy of the SAPIEN 3 TAVI device). A previously published two-stage Markov-based model that captured clinical outcomes from the PARTNER 3 trial was adapted from the perspective of the Swiss compulsory health insurance system, using local or geographically close general population mortality and utility data, unit costs and medical resource use from publicly available sources and based on expert opinion. The model had a lifetime horizon with a 3% yearly discounting factor. The cost-utility analysis estimated changes in both direct healthcare costs and health-related quality-adjusted life years for transcatheter aortic valve implantation compared with surgical aortic valve replacement in patients with symptomatic severe aortic stenosis at low risk of surgical mortality. Overall, transcatheter aortic valve implantation with SAPIEN 3 resulted in lifetime costs per patient of CHF 79,534 and quality-adjusted life years per patient of 9.64, compared with surgical aortic valve replacement lifetime costs and quality-adjusted life years per patient of CHF 76,891 and 8.96, respectively. Compared with surgical aortic valve replacement, transcatheter aortic valve implantation was estimated to offer an incremental improvement of +0.68 quality-adjusted life years per patient at an increased cost of +CHF 2643 per patient over a lifetime horizon. The incremental cost-effectiveness ratio was CHF 3866 per quality-adjusted life year gained and remained below CHF 50,000 per quality-adjusted life year gained across several sensitivity analyses. This analysis suggests that transcatheter aortic valve implantation using the SAPIEN 3 device is likely to be a highly cost-effective alternative for symptomatic severe aortic stenosis patients at a low risk of surgical mortality, treated in the contemporary Swiss setting. These findings may help to inform a holistic approach when making policy decisions for the management of this patient group.