Transcatheter Aortic Valve Replacement In Patients Research Articles

Long-Term Durability of Transcatheter Aortic Valve Prostheses in Patients With Bicuspid Versus Tricuspid Aortic Valve.

Currently, there is a lack of evidence for the long-term bioprosthetic valve durability of patients with bicuspid aortic valve (BAV) following transcatheter aortic valve replacement (TAVR). This study aimed to evaluate hemodynamic outcome, structural valve deterioration, and bioprosthetic valve failure during long-term follow-up after TAVR in patients with BAV versus patients with tricuspid aortic valve (TAV). Patients with BAV and TAV who underwent TAVR between 2012 and 2020, with echocardiography followed for at least 3 years, were included. Baseline characteristics, long-term valve hemodynamic performance, structural valve deterioration, and bioprosthetic valve failure were compared between patients with BAV and TAV. A total of 170 patients with BAV and 145 patients with TAV were included. The mean duration of follow-up for patients with BAV and TAV was 5.2±1.8 and 5.0±1.7 years. No significant differences were observed in the rates of structural valve deterioration and bioprosthetic valve failure between patients with BAV and TAV: structural valve deterioration, BAV 20 (11.8%) versus TAV 16 (11.0%) at last follow-up (P=0.861); bioprosthetic valve failure, BAV 3 (1.8%) versus TAV 7 (4.8%) at last follow-up (P=0.196). More than moderate intravalvular aortic regurgitation (1.8% versus 4.8%, P=0.196) and paravalvular leak (6.5% versus 3.4%, P=0.305) were rare in both patients with BAV and patients with TAV. This study indicated satisfactory long-term valve durability of TAVR in patients with BAV. Comparable hemodynamic outcome, structural valve deterioration, and bioprosthetic valve failure could be achieved in patients with BAV and TAV during long-term follow-up after TAVR.

Coronary access after Transcatheter Aortic Valve Replacement (TAVR): a systematic review and meta-analysis of observational studies

Abstract Introduction Over the past two decades, transcatheter aortic valve replacement (TAVR) has transformed the management of aortic stenosis, initially for high-risk surgical candidates and subsequently for low-risk patients. However, with the expanding indications for TAVR to younger, lower-risk patients, it is crucial to assess not only the short-term clinical outcomes but also the long-term considerations for future interventions. The prevalence of coronary artery disease (CAD) in TAVR patients is relevant, and the optimal timing of percutaneous coronary intervention (PCI) remains a question, given the technical challenges associated with coronary access in TAVR patients. Methods We conducted a systematic literature review and meta-analysis according to Cochrane Collaborations and PRISMA guidelines. We included 19 eligible trials involving 1533 patients who underwent coronary angiography after TAVR. The primary endpoint was the incidence of successful selective coronary re-access. Secondary endpoints included semi-selective and non-selective access rates. The analysis was stratified by balloon-expandable (BEVs) and self-expandable valve (SEVs) types. Results Successful coronary access after TAVR was feasible in the majority of patients, with a higher success rate observed for the left main coronary artery (LM) compared to the right coronary artery (RCA). Balloon-expandable valves demonstrated the highest success rates in coronary ostia cannulation, achieving nearly 100% success for both LM and RCA. Among self-expandable valves, the Evolut R/PRO showed superior success rates in selective coronary access (76,85% (95%CI 53,34-100%) for LM and 57,27% (95%CI 32,8-81,74%) for RCA) compared to the CoreValve (45,62% (95%CI 0-92,78%) for LM and 49,19% (95%CI 0-100%) for RCA). Notably, the majority of coronary angiograms were performed due to acute coronary syndrome, primarily non-ST-segment elevation myocardial infarction (NSTEMI) and unstable angina (UA), 26,5% for NSTEMI and 23,4% for UA, respectively. Conclusions Selective coronary engagement after TAVR is generally achievable, with BEVs demonstrating superior success rates compared to SEVs. Among self-expandable valves, the Evolut R/PRO showed better outcomes than the CoreValve. These findings provide valuable insights into post-TAVR coronary access feasibility, reducing concerns about valve selection based on this criterion

Impact of epicardial adipose tissue and atrial functional impairment in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement

Abstract Background Recent studies outlined the additional prognostic value of atrial function in patients with severe aortic stenosis (AS) undergoing transcatheter aortic valve replacement (TAVR). At the same time, increased epicardial adipose tissue (EAT) volumes have proven impact on atrial functional impairment in cardiovascular disease by nurturing adverse atrial remodelling. Purpose To explore the impact of increased EAT volumes as a potential pathomechanistic factor of atrial functional impairment in patients with severe AS undergoing TAVR. Methods 146 patients with severe AS underwent cardiac magnetic resonance (CMR) within 48h prior to TAVR between January 2017 and June 2021. Image analyses included myocardial volume quantification as well as CMR-feature-tracking derived strain. EAT volumes were manually delineated on short axis stacks in end-diastolic cardiac phases and indexed to body surface area. Functional and morphological parameters were compared between patients with high and low EAT volumes. Associations between morphological and functional parameters and EAT were tested using a multivariable linear regression model including patient specific parameters. Results After dichotomization at the median of 46.5ml/m2 total EAT volume, patients were assigned to high- and low-EAT groups accordingly. There was comparable age and body mass index and similar rates of co-morbidities such as hypertension, diabetes and atrial fibrillation in both groups. We observed a higher number of male patients in the high-EAT group (36 [53%] vs. 50 [72%], p=0.018). Regarding left and right ventricular dimensions and function, no differences could be shown. Left atrial (LA) end-systolic volumes were significantly higher in the high-EAT group (29.4ml/ml² [19.7-39.4] vs. 40.9ml/ml² [30.2-59.3], p=0.008), while there were no significant differences in end-diastolic volumes. Furthermore, LA reservoir strain was significantly lower in the high-EAT group compared to the low-EAT group (18.0% [11.7-21.0] vs. 11.8% [7.7-16.4], p=0.008) and was independently associated with higher EAT volumes (p=0.018) irrespective of cardiovascular risk factors and left ventricular (LV) systolic function in a multivariable regression model. Conclusion In patients with severe AS undergoing TAVR, increased EAT volumes are associated with both, morphological and functional changes of the atria. As impaired atrial function was previously shown to be an important predictor of mortality in TAVR patients, those results potentially render EAT as an additional pathomechanistic link between atrial remodelling and worse outcome in TAVR patients.

Association of cardiac amyloidosis with periprocedural complications in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement: a systematic review and meta-analysis

Abstract Introduction Cardiac amyloidosis (CA) has been frequently observed in patients with aortic stenosis (AS). While transcatheter aortic valve replacement (TAVR) may be an option, the association of CA with risk of periprocedural complications has not been well evaluated. Purpose This study aimed to evaluate the association of CA with periprocedural complications after TAVR in patients with severe AS. Methods A literature search was performed for studies evaluating patients with severe AS undergoing AVR, comparing periprocedural safety endpoints for patients with and without CA. The primary endpoints were vascular complications and bradyarrhythmias post-TAVR requiring permanent pacemaker (PPM) implantation. Secondary endpoints included periprocedural acute kidney injury (AKI), cerebrovascular accidents (CVA), and major bleeding events. Endpoints were defined using the Valve Academic Research Consortium-2 criteria. The search was not restricted to time or publication status. Results 6 studies with 1,138 patients with severe AS (150 with CA, 988 without CA) met inclusion criteria. Mean age was 82 years, 52.4% were men, all except 1 study assessed only patients with ATTR CA. Echocardiographic mean aortic valve parameters included valve area of 0.718 cm2, mean gradient of 40.8, and peak velocity of 4.13 m/s. The mean left ventricular ejection fraction was 55.2%. The presence of CA was not associated with an increased risk of periprocedural vascular complications (OR 0.69, 95% CI 0.25-1.88; p=0.47). While a trend toward higher risk of periprocedural PPM implantation was observed in patients with CA, this finding did not reach statistical significance (OR 1.51; 95% CI 0.77-2.94; p=0.23). The presence of CA was not associated with increased risk of periprocedural AKI, CVA, or major bleeding (OR 1.3, 95% CI 0.32-5.3; p=0.72, OR 0.65, 95% CI 0.17-2.41; p=0.52; OR 0.55, 95% CI 0.16-1.87; p=0.34). Conclusion In the context of patients with severe AS undergoing TAVR, the presence of cardiac amyloidosis did not increase the risk of periprocedural complications, including vascular complications, AKI, CVA, or major bleeding. Although a trend toward a higher risk of bradyarrhythmias requiring PPM implantation was noted in patients with CA, further studies are warranted to confirm this observation. Overall, these findings contribute valuable insight into the safety profile of TAVR in the patients with CA.Figure 1Figure 2

Myocardial work and aortic valve stenosis cardiac damage stages are predictors of all-cause mortality in patients undergoing transcatheter aortic valve replacement

Abstract In aortic stenosis (AS) patients, assessment of left ventricular (LV) systolic function is complicated due to the significant impact of increased afterload on conventional parameters. Myocardial work (MW) analysis, a novel echocardiographic method adjusts myocardial deformation to instantaneous LV pressure which may better reflect the LV contractile state. Importantly, long-term LV pressure overload has marked backward effects beyond the LV: classification of this extravalvular cardiac damage effectively represents the involvement of the cardiopulmonary system in AS. Both MW and cardiac damage staging could hold remarkable prognostic power in the clinically complex population of transcatheter aortic valve replacement (TAVR) candidates. Accordingly, our aim was to assess the prognostic value of MW analysis and cardiac damage staging in patients undergoing TAVR. We enrolled 289 patients (79±6 years, 41% female) prior to TAVR. Echocardiographic measurements were performed one day before the procedure. We calculated LV ejection fraction (EF) and by speckle-tracking echocardiography global longitudinal strain (GLS), as well. Global constructive work (GCW) was quantified with dedicated software and LV pressure was estimated using transaortic mean gradient and systolic blood pressure. Based on the echocardiographic data, we also determined the extent of cardiac damage associated with AS: patients were classified as Stage 0 (no cardiac damage), Stage 1 (LV damage), Stage 2 (mitral valve or left atrial damage), Stage 3 (pulmonary artery vasculature or tricuspid valve damage), or Stage 4 (right ventricular damage). Our primary outcome was all-cause mortality, reached by 68 patients (median follow-up: 26 months). In our cohort, preprocedural EF was 47±13 %, GLS was -12.3±4 %, while GCW was 2043±791 mmHg%. 14 (5%) patients were classified as Stage 0, 61 (21%) as Stage 1, 128 (44%) as Stage 2, 15 (5%) as Stage 3, and 71 (25%) as Stage 4. GCW showed a continuous decline through the AS Stages (from Stage 0-4: 2963±652 vs. 2154±652 vs. 2168±718 vs. 1988±969 vs. 1552±772 mmHg%; p<0.001). Using univariate Cox analysis GCW (HR 0.968 [95% CI 0.938-0.998] per 100 unit change; p=0.034) and AS Staging (HR 1.236 [95% CI 1.015-1.505]; p=0.035) were both associated with all-cause mortality, while EF (HR 0.984 [95% CI 0.966-1.002]; p=0.085) and GLS (HR 1.042 [95% CI 0.984-1.103]; p=0.160) were not. In multivariate Cox regression models, both GCW (HR 0.957 [95% CI 0.922-0.992] per 100 unit change; p=0.018) and AS cardiac damage staging (HR 1.263 [95% CI 1.029-1.549]; p=0.025) were proven to be significant independent predictors of all-cause mortality. In TAVR patients, preoperative GCW values exhibited a persistent decrease across AS Stages. As opposed to EF and GLS, GCW and AS Staging both showed strong association with all-cause mortality in our cohort. Moreover, GCW had higher prognostic value than any other conventional or advanced measure of LV function.

Survival penalty in patients undergoing transcatheter versus surgical aortic valve replacement: is it just a question of frailty? Insights from a large cohort with demographic matching

Abstract Background Transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR) are the reference treatments for aortic stenosis. Conflicting data exist on late survival results of these two techniques. While randomised controlled trials (with highly selected patients) assert the non-inferiority of TAVR, real-world data from large registries (with potential uncorrected confounders) suggest the opposite. Comparing the survival rates of SAVR and TAVR with those of a matched reference population could help circumvent potential biases of direct procedural comparisons and quantify the impact of frailty on post-operative survival. Purpose Our study aims to compare the 5-year overall survival rates of SAVR, non-frail TAVR, and frail TAVR patients with the survival of their demographically matched reference population. Methods This study included all consecutive patients undergoing either SAVR or TAVR at a tertiary hospital between January 2010 and December 2021. Each patient underwent a comprehensive geriatric assessment by an experienced geriatric team, from which a Clinical Frailty Scale (CFS) was derived using a validated classification tree. Frailty was defined as a CFS ≥ 6, in accordance with ESC guidelines. The patients were stratified into 3 subgroups: SAVR, non-frail TAVR, and frail TAVR patients. For each subgroup, a corresponding reference population was generated using national actuarial tables to ensure individual-level matching based on age, gender, and year of observation. Survival of each subgroup was then compared to its corresponding reference population over a 5-year period using standardized mortality ratios (SMR) and one-sample logrank tests. Results Our cohort included 1183 SAVR, 254 non-frail TAVR, and 151 frail TAVR patients, with mean ages of 74.1, 85.4, and 85.7 years, and median EuroSCORE II of 2.0%, 4.2%, and 5.4%, respectively. Survival of SAVR patients was equivalent to the reference population (80.1 vs 80.9% survival; SMR = 1.06 [0.89 – 1.25]; p = 0.454; Figure 1A). Similarly, non-frail TAVR patients also achieved survival rates comparable to those of the reference population (50.9 vs 54.0% survival; SMR = 0.94 [0.76 – 1.18]; p = 0.549; Figure 1B). However, frail TAVR patients faced a significantly reduced survival rate (41.7% vs 54.0% survival; SMR = 1.48 [1.15 – 1.90]; p < 0.001; Figure 1C). The frailty of this subgroup could therefore explain a 48% increase in mortality risk compared with their reference population after 5 years. Conclusions Treating non-frail patients with aortic stenosis through TAVR or SAVR restores life expectancy to levels comparable with their reference population, challenging results from other real-world registries. In contrast, TAVR in frail patients is associated with worse survival, raising the question of treatment futility in this specific subgroup. Refining the selection of frail patients who may benefit from TAVR remains an important clinical challenge.

Socioeconomic disparity in utilization of transcatheter aortic valve replacement

Abstract Introduction Transcatheter aortic valve replacement (TAVR) is a major therapeutic option, rapidly replacing surgical aortic valve replacement (SAVR) in patients with aortic stenosis (AS) in recent years. However, the use of TAVR may vary with the socioeconomic status (SES) since new technologies are more likely to have the lower accessibility in some medico-social environments. In South Korean patients with AS, we investigated the difference in the use of TAVR based on SES and whether the difference influences clinical outcomes of patients with AS. Methods Between 2010 and 2020, 30,142 patients newly diagnosed with AS in a tertiary or regional center were investigated through the Korean National Health Insurance System (KNHIS). Patients were received either medical, SAVR or TAVR therapy for AS. The patients were categorized into 3 groups based on the insurance premium level (IPL) of the KNHIS (IPL1, <100 KW; IPL2, 100-249 KW; IPL3, ≥250KW). AS-related death was defined as death by AS, heart failure or ventricular arrhythmia. Cardiovascular (CV) death was defined as AS-related death or death by myocardial infarction or stroke. The study period was divided at year 2015, when the partial coverage for TAVR was implemented by the KNHIS. Results The numbers of patients referred to the tertiary/regional centers have continuously grown for the 11 years but the referring rate has grown even faster since 2015. The proportions of TAVR has increased while that of SAVR has decreased since 2015. TAVR was more frequently chosen by patients with a higher IPL (5.5%, 8.0% and 12.5%, respectively in the IPL1, IPL2 and IPL3, p<0.001), whereas the medical therapy appeared not affected by the IP levels. The patients in the IPL2 (odd ratio [OR] 1.33 [1.20-1.47]) and IPL3 (OR 1.65 [1.45-1.86]) had a higher chance to undergo TAVR than those in the IPL1 whereas the patients in the IPL3 was a lower chance to undergo SAVR than those in the IPL1 (OR 0.86 [0.78-0.94]). In patients with severe AS, the disparities between the IPL1 and IPL3 exaggerated (OR 1.99 [1.70-2.33]) (Figure 1). Higher IPLs were associated with lower risks of CV death and AS-related death. Time-varying Cox proportional hazard models showed that TAVR was associated with a lower risk of CV death than both medical therapy and SAVR in the entire study period and in year 2015 or later, whereas TAVR was associated with a lower risk of AS-related death than the both only in year 2015 or later, after adjustment of relevant covariates including the IPL (Figure 2). The choice of TAVR significantly medicated the associations between IPLs and the risk of CV death (responsible for 3.0% in the IPL2 and 4.1% in the IPL3). Conclusion The SES based on the IPL is independently associated with the choice of TAVR in patients with AS and the association has become stronger since 2015. The disparity in use of TAVR could mediate more frequent CV deaths in patients with the lower IPL.Figure 1Figure 2

Concomitant left atrial appendage occlusion and transcatheter aortic valve replacement among patients with atrial fibrillation: an updated systematic review and meta-analysis

Abstract Background Atrial fibrillation (AF) is a prevalent arrhythmia in patients undergoing transcatheter aortic valve replacement (TAVR). Left atrial appendage occlusion (LAAO) has emerged as a viable strategy to prevent stroke in selected patients with AF. While both devices can be implanted simultaneously during a single procedure, the safety and efficacy of this approach remain uncertain. Purpose This study aims to evaluate the efficacy and safety of concomitant LAAO in patients with AF and aortic valve disease undergoing TAVR. Methods We conducted a systematic review and meta-analysis of randomized controlled trials and observational studies that compared concomitant TAVR and LAAO with isolated TAVR. The study's primary outcomes were all-cause mortality, stroke or transient ischemic attack (TIA), and major bleeding. We established a minimum follow-up time of six months. Results Three studies met our eligibility criteria, including one randomized controlled trial and two observational studies. The meta-analysis included 570 patients, 249 (44%) who underwent LAAO and TAVR, with a mean follow-up of 16.3 months. In the overall population, there was no significant difference between the groups in all-cause mortality (relative risk [RR] 0.95; 95% confidence interval [CI] 0.67-1.35; p = 0.78; figure 1A), major bleeding (RR 1.15; 95% CI 0.75-1.77; p = 0.51; 1B), and stroke or TIA (RR 0.70; 95% CI 0.33-1.45; p = 0.33; figure 1C). Conclusion In conclusion, concomitant LAAO and TAVR did not demonstrate discernible clinical differences compared to isolated TAVR in patients with AF and aortic valve disease. We recommend that this therapeutic approach be individualized until more robust data become available.

Inter-ethnic heterogeneity in valvular morphology and aortopathy of a worldwide bicuspid aortic valve cohort referred for TAVR

Abstract Background Bicuspid aortic valve (BAV) represents one of the most common congenital heart disease. BAV stenosis tipycally occurs in younger, low-surgical risk patients compared to tricuspid aortic valves (TAV). With the predicted expansion of trans-catheter aortic valve replacement (TAVR) into lower-risk patients, the proportion of BAV is expected to rise. Although some observational studies have investigated the characteristics of Asian versus European patients with BAV undergoing TAVR, little is known about the inter-ethnic differences within the large and diverse Asian, African, Russian, and Caucasian population. Purpose To evaluate the inter-ethnic differences of aortic valve morphology, annular size and associated aortopathy, in a worldwide population of patients with severe aortic stenosis referred for TAVR. Methods Cardiovascular multislice computed tomography data of patients with severe aortic valve stenosis referred for TAVR worldwide were obtained from the database of the Meril Life Core Lab. Inter-ethnic and epidemiological differences in terms of valvular phenotype, annular size and aortic morphology were evaluated with particular focus on patients with BAV. Results Among 12,712 patients (59% male), n=3,203 subjects (25%) exhibited a BAV morphology. According to the Siever’s BAV classification, type 1 (71%, n=2,284) was the most prevalent BAV morphology and particularly Type 1a was the most common in almost all population, with 26% exhibiting a type 0 BAV, while only 3% of the patients (n= 92) had a type 2 (Table 1). A significantly higher prevalence of severe calcium score (>1000 mm3) was found in patients with BAV compared with patients exhibiting a TAV morphology (51% vs. 32, p<0.01). Additionally, larger ascending aorta (AA) diameter (AA >40 mm) (BAV: 31% vs TAV 7%, p = 0.04), along with a higher prevalence of horizontal aorta (HA) (BAV: 20% vs TAV: 9%, p<0.01) was found in patients with BAV compared with TAV. As for inter-ethnic characteristics, there was a higher prevalence of BAV in Indian and Asian Pacific populations (respectively 43% and 28%), with the African population exhibiting the lowest prevalence (7%, n= 28, p=0.02) (Table 2). In Indian patients a higher prevalence of BAV was found in an earlier age (61-70 years old) compared to Western countries (p=0.05). Finally, smaller annular size (456±98 mm2 vs 584±99 mm2, p<0.01) and lower coronary ostia height (Asia and India: RCA 14.5±3 mm, LCA 14±2.9mm vs Caucasian and Russian: RCA 16±3.2 mm, LCA 16.9±3.3mm; p<0.01) were found in the Asian and Indian population when compared with Russian, African and Caucasian subjects. Conclusions BAV morphology, aortopathy and annular size resulted widely heterogenous according to the ethnicity and geographical origin of patients referred for TAVR worldwide. These features may lead different therapeutical decision making and outcomes following TAVR in patients with BAV.Table 1Table 2

Real-world analysis of transcatheter aortic valve replacement in patients with prostate cancer and severe aortic stenosis

Abstract Background Patients with prostate cancer have a high prevalence of cardiovascular disease, including degenerative heart valve diseases such as aortic stenosis. It is not uncommon in clinical practice to perform transcatheter aortic valve replacement (TAVR) in patients with severe aortic stenosis and active prostate cancer. Still, the prognosis after this procedure in this population is not well known. Purpose To evaluate 1-year and 3-year survival rates after TAVR in patients with prostate cancer who have undergone TAVR when compared with patients without active cancer. Methods Data were extracted from electronic medical records of a large multinational collaborative network (TriNetX) that currently englobes 113 healthcare organizations worldwide with more than 100 million patients. Patients aged 18 years or older with prostate cancer documented up to 12 months before TAVR as well as controls undergoing TAVR without oncologic history before the proceeding were included. The survival analysis for 1 year and 3 years was performed with Kaplan Meier survival plots and log-rank test. Propensity score matching, using clinical and demographic variables, was performed to pair the cohorts. Results From a cohort of 26,656 men who had undergone TAVR, we identified 1,040 with prostate cancer diagnosed up to 1 year before TAVR ( prostate cancer group) and 20,231 patients without oncologic history before TAVI (control group). After propensity score matching, analyzing 1,040 patients in each group, the 1-year and 3-year survival probabilities were not different between the prostate cancer group versus the control group ( 89.5% vs 88.9%, log-rank test P=0.70 and 72.6% vs 68.7%, log-rank test P=0.22, respectively). Considering a subgroup of patients with metastatic prostate cancer ( n=229) under androgen deprivation therapy vs the control group ( n =229), we have also not observed a survival difference between the two groups at 1-year and 3-year follow-up ( 88.1 vs 89.1%, log-rank test P=0.69 and 58.7% vs 67.4%, log-rank test P=0.25). Conclusions In this real-world analysis, patients with prostate cancer and severe aortic stenosis who underwent TAVR, including patients with metastatic disease, the 1-year and 3-year survival rates were not significantly different when compared to patients without oncologic hystory who underwent TAVR.

Evolution and prognostic impact of left ventricular myocardial work indices after transcatheter aortic valve replacement in patients with severe aortic stenosis

Abstract Introduction Left ventricular myocardial work (LVMW) is an echocardiographic-based technique to evaluate LV function using pressure-strain loops and therefore correcting for the left ventricular (LV) afterload. LVMW indices have been shown to be of prognostic importance in patients with aortic stenosis (AS) before transcatheter aortic valve replacement (TAVR), but no data is available on the evolution and the prognostic value of these parameters after TAVR. Purpose To measure LVMW indices before and after TAVR in patients with severe AS and explore the association with outcome. Methods As previously validated, LV global longitudinal strain (GLS) and LV systolic pressure (as the sum of the brachial arterial blood pressure and mean aortic valve gradient before TAVR and as brachial arterial blood pressure after TAVR) were incorporated to build pressure-strain loops and to calculate the following LVMW indices: global work index (LV GWI), global constructive work (LV GCW), global wasted work (LV GWW) and global work efficiency (LV GWE). The endpoint was all-cause mortality. Results A total of 255 patients were included with a median age of 82 years (IQR 77-85); 51% were men and 67% presented with NYHA class III/IV. After TAVR, LVEF and LV GLS remained in average unchanged (from 56 to 55%, p=0.470 and from 13.6 to 13.2%, p=0.068). While LV GWW remained unchanged after TAVR (from 247 to 258mmHg%, p=0.080), LV GWI, LV GCW and LV GWE significantly decreased (from 1882 to 1291mmHg%, p <0.001, from 2248 to 1671mmHg%, p <0.001 and from 89 to 85%, p <0.001 respectively). During a median follow-up of 59 months (IQR 40-72), 129 patients died. Univariable Cox regression analysis identified an association between all-cause mortality and male sex, diabetes mellitus, chronic obstructive pulmonary disease (COPD), renal function, atrial fibrillation, Charlson comorbidity index, pacemaker implantation, and post-TAVR LV GLS, LV GWI and LV GCW. These clinical parameters were used as a basal multivariable Cox regression model of which on top either post-TAVR LV GLS, LV GWI or LV GCW were added. All these parameters of post-TAVR LV systolic function showed an independent association with all-cause mortality, but LV GWI demonstrated the highest increase in model predictivity (Figure 1). Given the prognostic relevance of post-TAVR LV GWI, the population was divided into LV GWI tertiles. The group with the lowest LV GWI tertile showed a significantly higher proportion of male patients, higher prevalence of atrial fibrillation and also worse pre-TAVR LVEF, LV GLS, LV GWI, LV GCW and LV GWE. Kaplan Meier survival analysis confirmed the worse survival in the group with the lowest LV GWI compared to the highest tertile (log-rank ꭓ2: 8,224, p 0.016, Figure 2). Conclusion LVMW indices change after TAVR and post-TAVR LV GLS, LV GWI, LV GCW are independently associated with all-cause mortality. Among these parameters, LV GWI yielded the highest prognostic value.

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

Gender-related differences in the timing of intervention for aortic stenosis: focus on cardiac damage

Abstract Background and aim: There is an increasing awareness of gender-related differences in the management of cardiovascular diseases. Our aim was to assess whether cardiac damage prior to intervention for severe aortic stenosis (AS) differs according to gender. Methods Retrospective analysis of a prospective cohort of patients with AS who underwent surgical aortic valve replacement (SAVR) and transcatheter aortic valve replacement (TAVR) in a tertiary care center from 2017 to 2022. Echocardiographic parameters prior to surgery were collected, and patients were classified into categories of a cardiac damage staging system. (1) Several echocardiographic variables according to gender were evaluated. Results 869 patients were included, of which 350 underwent TAVR and 519 were treated with SAVR. Females represented 52.4% (n=272) of TAVR patients and 37.7% (n=132) of SAVR patients. In the echocardiogram performed before the intervention, both in the TAVR and the SAVR cohort, female patients had worse diastolic function (significantly higher values of E/e’), and greater involvement of pulmonary vasculature damage (significantly higher pulmonary artery systolic pressure and worse right ventricular-arterial coupling (Table-Figure 1). When applying an available cardiac damage staging system (1), we documented that women were treated at a statistically significant more advanced stage compared to men (Figure 2). Conclusions There are gender-related differences in the timing of aortic stenosis intervention, both with TAVR and SAVR. Women are operated on at a more advanced stage of cardiac damage, particularly regarding the parameters of diastolic function and right-side damage. These findings should be taken into account to improve intervention timing and outcomes, especially for women.Table-Figure 1Figure 2

Three-Year Outcomes Following TAVR in Younger (

Transcatheter aortic valve replacement (TAVR) is an alternative to surgery in patients with severe aortic stenosis, but data are limited on younger, low-risk patients. This analysis compares outcomes in low-surgical-risk patients aged <75 years receiving TAVR versus surgery. The Evolut Low Risk Trial randomized 1414 low-risk patients to treatment with a supra-annular, self-expanding TAVR or surgery. We compared rates of all-cause mortality or disabling stroke, associated clinical outcomes, and bioprosthetic valve performance at 3 years between TAVR and surgery patients aged <75 years. In patients <75 years, 352 were randomized to TAVR and 351 to surgery. Mean age was 69.1±4.0 years (minimum 51 and maximum 74); Society of Thoracic Surgeons Predicted Risk of Mortality was 1.7±0.6%. At 3 years, all-cause mortality or disabling stroke for TAVR was 5.7% and 8.0% for surgery (P=0.241). Although there was no difference between TAVR and surgery in all-cause mortality, the incidence of disabling stroke was lower with TAVR (0.6%) than surgery (2.9%; P=0.019), while surgery was associated with a lower incidence of pacemaker implantation (7.1%) compared with TAVR (21.0%; P<0.001). Valve reintervention rates (TAVR 1.5%, surgery 1.5%, P=0.962) were low in both groups. Valve performance was significantly better with TAVR than surgery with lower mean aortic gradients (P<0.001) and lower rates of severe prosthesis-patient mismatch (P<0.001). Rates of valve thrombosis and endocarditis were similar between groups. There were no significant differences in rates of residual ≥moderate paravalvular regurgitation. Low-risk patients <75 years treated with supra-annular, self-expanding TAVR had comparable 3-year all-cause mortality and lower disabling stroke compared with patients treated with surgery. There was significantly better valve performance in patients treated with TAVR. URL: https://clinicaltrials.gov; Unique identifier: NCT02701283.

Prospective study on the impact of different antithrombotic therapies on subclinical leaflet thickening and its temporal dynamics in transcatheter aortic valves—The NOTION-4 trial

Transcatheter aortic valve replacement (TAVR) has become the standard-of-care treatment for a majority of patients with severe, symptomatic aortic stenosis. The post-procedural anti-thrombotic therapeutic management is still a topic of debate and could affect the incidence of HALT, a phenomenon which can be assessed by four-dimensional computed tomography (4DCT). The NOTION-4 trial is a randomized controlled trial comprising TAVR patients with no indication for oral anticoagulant (OAC) therapy, comparing lifelong single anti-platelet therapy (standard arm) versus early 3-month direct oral anticoagulant (DOAC) therapy followed by single anti-plateletet therapy (experimental arm). The incidence of HALT and clinical endpoints will be evaluated in both groups at 3 months, 1 year and 5 years after randomization. The primary endpoint is the number of patients with at least one bioprosthetic aortic valve leaflet with HALT as assessed by cardiac 4DCT imaging at 1 year. The trial is powered for superiority testing and started enrollment in 2021. In total, 324 patients will be included. The last patient is expected to be enrolled by the end of 2024 and the primary endpoint is to be presented in 2026. The NOTION-4 trial aims to study whether an early 3-month DOAC therapy after TAVR can result in a sustained lower incidence of HALT in transcatheter aortic valves. This trial holds the potential to give valuable insights into whether early OAC therapy should be integrated in future guidelines for post-TAVR anti-thrombotic therapeutic management. NOTION-4, ClinicalTrials.gov ID NCT06449469, https://clinicaltrials.gov/study/NCT06449469.

TCT-188 Inpatient Outcomes of Transcatheter Aortic Valve Replacement Patients on Chronic Anticoagulation: A Nationwide Analysis

TCT-188 Inpatient Outcomes of Transcatheter Aortic Valve Replacement Patients on Chronic Anticoagulation: A Nationwide Analysis

Left Ventricular Hypertrophy Regression Following Transcatheter Aortic Replacement: A Comparison of Self-Expanding Versus Balloon-Expandable Prostheses

There are limited reports on the impact of prosthesis-patient mismatch (PPM) on the regression of left ventricular hypertrophy (LVH) after transcatheter aortic valve replacement (TAVR). We compared the relative effects of supra-annular, self-expanding (SE) versus intra-annular, balloon-expandable (BE) prostheses on TAVR LVH regression. Regression of left ventricular mass index (LVMi) was evaluated in 168 consecutive TAVR patients, including 60 treated with SE valves (Evolut series) and 108 treated with BE valves (Sapien 3). All patients had LVH determined at baseline by echocardiography and had repeat LVMi measurements at a mean follow-up time of 707 ± 528 days. SE patients were more likely female (68.3% vs 46.3%, p = 0.007), but otherwise, the 2 cohorts did not differ with respect to baseline demographics and Society of Thoracic Surgeons risk score. SE patients had a higher effective orifice area indexed to body surface area after TAVR (0.98 ± 0.29 vs 0.86 ± 0.25 cm²/m², p = 0.006), with lower mean aortic valve gradients (9.9 ± 6.5 vs 12.8 ± 5.8 mm Hg, p = 0.003) and a lower prevalence of moderate/severe PPM (33.3% vs 49.1%, p = 0.049). On follow-up, changes in LVMi were similar between the SE and BE groups, with similar absolute changes in LVMi (19.2 ± 26.8 vs 21.9 ± 31.7 g/m2, p = 0.578) and relative LVMi decrease (14.0 ± 19.5 vs 16.2% ± 24.2%, p = 0.547). No difference in LVMi regression was also noted comparing combined SE/BE patients with moderate/severe PPM versus those without PPM. In conclusion, despite differences in effective orifice area indexed to body surface area, mean aortic valve gradient, and PPM after TAVR, the degree of LVH regression during intermediate follow-up did not differ between patients receiving supra-annular SE and intra-annular BE prostheses.

Effect of Mechanical Circulatory Support on Mortality After Transcatheter Aortic Valve Replacement: A Landmark Analysis.

A proportion of patients still need mechanical circulatory support (MCS) during the transcatheter aortic valve replacement (TAVR) because of intraoperative hemodynamic instability. However, the outcomes of patients with different MCS type during TAVR are still controversial. A total of 538 patients who underwent TAVR procedure in four centers were included. The time-related outcomes and their predictors of patients who did not have MCS (MCS-, n = 498) were compared with those who underwent emergency MCS (eMCS+, n = 18) and prophylactic MCS (pMCS+, n = 22). We evaluated the association between different MCS groups and all-cause mortality using conditional landmark analysis with Cox regression. There was a significant increase in 30-day mortality in the eMCS+ group (plog-rank < 0.001) and no significant difference in 31-day to 1-year mortality among the groups (plog-rank = 0.789). A significant improvement in the left ventricular ejection fraction was observed in the pMCS+ group at 1 year after TAVR. Emergency MCS was independently associated with 30-day mortality, as well as 1-year mortality. Prophylactic MCS showed good clinical outcomes and might be considered for high-risk patients. Further studies are needed to investigate the predictors that lead to MCS usage and long-term mortality in TAVR patients with MCS.

Barriers and facilitators of the nurse providing evidence-based preoperative visit-care for transcatheter aortic valve replacement: a mixed-methods study based on an evidence application setting

BackgroundPreoperative visit-care for transcatheter aortic valve replacement (TAVR) plays a crucial role in improving the quality of care and patient safety. However, preoperative care for TAVR patients is still in its early stages in China, with the care often being experience-based. The application of relevant evidence in nursing practice is necessary. Little is known regarding the facilitators and barriers to apply and compliance to the evidences about preoperative visit-care for TAVR in nursing.MethodsThe Nurse’s Compliance Checklist was used to investigate the evidence-based compliance of nurses (n = 21) who worked in the TAVR team in the evidence-based implementation setting. Meanwhile, an Evidence-Based Practice Beliefs Scale, and Influencing Factors Checklist were used to investigate all nurses (n = 66) who work in the same setting. Stakeholders (Middle and senior-level nursing administrators, frontline clinical nurses, and patients) interview was carried out to further disclose the barriers and facilitators in the process of evidence-based practice.ResultsThe results of this study showed that only 1 evidence implemented fully (100%) by nurses, 3 evidences with 0% implementation rate, and implementation rate of the other evidences were 9.5∼71.4%. The overall score of nurses’ evidence-based nursing belief level was (3.52 ± 0.82). Three domains of barriers were identified: the Context Domain included lack of nursing procedures, inadequate health education materials, insufficient training; the Practitioner Domain included insufficient attention, lack of relevant knowledge, high work pressure and uncertainty of expected results, and Patient Domain included lack of relational knowledge. Facilitating factors included leadership support, nurse’ high evidence-based nursing belief, high executive ability and enthusiasm for learning.ConclusionThe study indicated that the nurses’ compliance of evidence-based practice in preoperative visit-care for TAVR was in lower level. There were some factors influencing the application of the evidences. The study revealed potential modifiable barriers to the successful implementation of evidence-based preoperative visit-care, including a lack of preoperative visit- care routine, related knowledge and training. Leadership support and nurse training should be considered to improve nurses’ compliance with evidence-based practice.

Hematological Complications From Transcatheter Aortic Valve Replacement (TAVR): Recognition and Treatment.

Transcatheter aortic valve replacement (TAVR) has emerged as a pivotal intervention for patients with severe aortic stenosis who are at high or prohibitive surgical risk. Although TAVR is a minimally invasive procedure, it is linked to serious hematological problems, most notably thrombosis and bleeding. Numerous factors, such as procedural features, patient comorbidities, and anticoagulation management techniques, contribute to these complications. Bleeding complications can be major, minor, or life-threatening. They can be caused by problems with the vascular access site, anticoagulation medication, or coexisting conditions like renal dysfunction and frailty. Hemoglobin drop, overt bleeding, and hematoma signs must all be closely watched to identify bleeding. Careful selection and modification of anticoagulation medication, the use of vascular closure devices, and timely attention to bleeding sites are examples of management techniques. Thrombotic consequences, which include cerebrovascular accidents and valve thrombosis, are caused by endothelial injury, stent implantation, and patient hypercoagulability. Imaging modalities such as computed tomography and transesophageal echocardiography are used in the crucial process of detection. The goal of preventive care is to maximize anticoagulation regimens that are customized to each patient's risk profile, frequently striking a balance between the risk of thrombosis and bleeding. A multidisciplinary strategy that integrates surgical, hematological, and cardiology expertise is necessary for the effective management of these hematological complications. To improve patient outcomes, ongoing research attempts to improve risk stratification and create safer anticoagulation protocols. This review emphasizes how critical it is to identify bleeding and thrombotic events as soon as possible and treat them promptly to reduce the risk of negative outcomes for TAVR patients.