The utility of the human epididymis protein 4 (HE4) in patients undergoing transcatheter aortic valve implantation (TAVI) has not been established yet.

The present study aimed at examining the prognostic value of HE4 in patients undergoing TAVI.

In this prospective study, the prognostic value of HE4 to predict adverse clinical events was evaluated in 362 patients who underwent TAVI. The association between HE4 and diffuse myocardial fibrosis was also assessed using T1 mapping on cardiac magnetic resonance in a subgroup of 43 patients.

During a median follow-up of 2.5 (IQR: 1.9-3.2) years, 34/362 (9.4%) patients were rehospitalized for heart failure, 99/362 (27.3%) died, and 113/362 (31.2%) met the composite endpoint of rehospitalization for heart failure or all-cause mortality. In multivariable Cox regression analyses, patients with higher HE4 serum levels (ie, HE4 ≥130 pmol/L) vs lower serum levels (ie, HE4 <130 pmol/L) had increased risk of all-cause mortality (adjusted HR: 3.26 [95% CI: 2.04-5.20], P < 0.001), and of the composite endpoint (adjusted HR: 2.48 [95% CI: 1.64-3.74], P < 0.001) following TAVI, respectively. Patients with higher HE4 serum levels had higher median native T1 mapping values (1,278 [95% CI: 1,239-1,280] ms vs 1,352 [95% CI: 1,303-1,376] ms, P < 0.001) at 1 to 3 months following the procedure.

Elevated HE4 serum levels are associated with diffuse myocardial fibrosis and increased risk of adverse clinical events following TAVI. This promising blood biomarker may be helpful to enhance risk stratification in patients undergoing TAVI.

Real-world low-risk transcatheter aortic valve replacement (TAVR) outcomes in the United States have not been assessed comprehensively versus pivotal trials, which is a key component of measuring the quality of clinical technology adoption.

We identified heart team-designated low-risk patients undergoing TAVR for trileaflet severe, symptomatic aortic stenosis in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Registry, as well as a subset of patients who met low-risk trial inclusion and exclusion criteria, from January 2020 to March 2024. Outcomes (mortality, stroke, new pacemaker, and "alive and well," defined as alive at 1 year with Kansas City Cardiomyopathy Questionnaire score ≥60 and ≤10-point decrease from baseline) at 30 days and 1 year were assessed. Multivariable models were developed to assess predictors of death and stroke within 1 year after TAVR.

Among 383 030 patients who underwent TAVR during the study period, 108 407 (28%) were designated low-risk by the heart team, and 68 194 (18%) met other study inclusion and exclusion criteria. Of these, 62% (n=42 093) would have been eligible for the low-risk trials. In the overall heart team-designated low-risk population, 30-day outcomes included 0.8% mortality, 1.5% stroke, and 8.4% new permanent pacemaker requirement; 1-year outcomes included 4.6% mortality, 2.6% stroke, and 90% alive and well. In the trial-eligible population, 0.6% mortality, 1.4% stroke, and 8.0% new permanent pacemaker requirement had occurred by 30 days; values at 1 year included 3.1% mortality, 2.4% stroke, and 92% alive and well. Notable multivariable predictors of 1-year mortality were atrial fibrillation, nontransfemoral access, and lower baseline Kansas City Cardiomyopathy Questionnaire score.

One-year outcomes among real-world trial-eligible patients are excellent, but adverse events are higher compared with published clinical trial data, likely because of greater comorbidity burden and lower baseline Kansas City Cardiomyopathy Questionnaire score. These data can help inform expected outcomes and health status after low-risk TAVR.

Up to one-third of patients undergoing transcatheter aortic valve replacement (TAVR) have an indication for oral anticoagulation (OAC), primarily due to underlying atrial fibrillation. The optimal approach concerning periprocedural continuation vs interruption of OAC in patients undergoing TAVR remains uncertain, which our meta-analysis aims to address.

To explore safety and efficacy outcomes for patients undergoing TAVR, comparing periprocedural continuation vs interruption of OAC therapy.

A literature search was conducted across major databases to retrieve eligible studies that assessed the safety and effectiveness of TAVR with periprocedural continuous vs interrupted OAC. Data were pooled using a random-effects model with risk ratio (RR) and their 95% confidence interval (CI) as effect measures. All statistical analyses were conducted using Review Manager with statistical significance set at P < 0.05.

Four studies were included, encompassing a total of 1813 patients with a mean age of 80.6 years and 49.8% males. A total of 733 patients underwent OAC interruption and 1080 continued. Stroke incidence was significantly lower in the OAC continuation group (RR = 0.62, 95%CI: 0.40-0.94; P = 0.03). No significant differences in major vascular complications were found between the two groups (RR = 0.95, 95%CI: 0.77-1.16; P = 0.60) and major bleeding (RR = 0.90, 95%CI: 0.72-1.12; P = 0.33). All-cause mortality was non-significant between the two groups (RR = 0.83, 95%CI: 0.57-1.20; P = 0.32).

Continuation of OAC significantly reduced stroke risk, whereas it showed trends toward lower bleeding and mortality that were not statistically significant. Further large-scale studies are crucial to determine clinical significance.

Neurohormonal modulation and afterload reduction are key for treatment of heart failure with reduced ejection fraction (HFrEF). In HFrEF patients with concomitant moderate aortic stenosis (AS), treatment with transcatheter aortic valve replacement (TAVR) may be complementary to guideline-directed medical therapy (GDMT).

This study sought to determine whether TAVR for moderate AS provides clinical benefit in patients with HFrEF on top of GDMT.

We performed an investigator-initiated, international, randomized controlled trial in patients with HFrEF on GDMT with moderate AS who were suitable for transfemoral TAVR with a balloon-expandable valve. Patients were randomized 1:1 to TAVR or clinical aortic stenosis surveillance (CASS) with aortic valve replacement upon progression to severe AS. The primary endpoint was the hierarchical occurrence of: 1) all-cause death; 2) disabling stroke; 3) disease-related hospitalizations and heart failure equivalents; and 4) change from baseline in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score analyzed using the win ratio.

From January 2017 to December 2022, 178 patients were randomized to TAVR (n = 89) or AS surveillance (n = 89). The mean age was 77 years, 20.8% were female, and 55.6% were in NYHA functional class III or IV. The median follow-up duration was 23 months (Q1-Q3: 12-33 months). A total of 38 (43%) patients in the CASS group (of whom 35 had progressed to severe AS) underwent TAVR at a median of 12 months postrandomization. TAVR was associated with wins in 47.6% of pairs, compared with 36.6% in the CASS group, resulting in a win ratio of 1.31 (95% CI: 0.91-1.88; P = 0.14). At 1 year, TAVR resulted in a greater improvement in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score compared with the CASS group (12.8 ± 21.9 points vs 3.2 ± 22.8 points; P = 0.018).

TAVR was not superior to AS surveillance for the primary hierarchical composite endpoint in patients with moderate AS and HFrEF on GDMT. Preemptive TAVR for moderate AS was safe and may provide clinically meaningful quality-of-life benefits.

Severe aortic stenosis (AS) is the most common valvular disease in the USA. Patients undergoing urgent or emergent transcatheter aortic valve replacement (TAVR) have worse clinical outcomes than those undergoing non-urgent procedures. No studies have examined the impact of procedural TAVR timing on outcomes in AS complicated by acute heart failure (AHF).

We aimed to evaluate differences in in-hospital mortality and clinical outcomes between early (<48 h) vs. late (≥48 h) TAVR in patients hospitalized with AHF using a real-world US database.

We queried the National Inpatient Sample database to identify hospitalizations with a diagnosis of AHF, aortic valve disease, and a TAVR procedure (2015-2020). The associations between TAVR timing and clinical outcomes were examined using logistic regression model.

A total of 25,290 weighted AHF hospitalizations were identified, of which 6855 patients (27.1 %) underwent early TAVR, and 18,435 (72.9 %) late TAVR. Late TAVR patients had higher in-hospital mortality rate (2.2 % vs. 2.8 %, p < 0.01) on unadjusted analysis but no significant difference following adjustment for demographic, clinical, and hospital characteristics [aOR 1.00 (0.82-1.23)]. Late TAVR was associated with higher odds of cardiac arrest (aOR 1.50, 95 % CI: 1.18-1.90) and use of mechanical circulatory support (aOR 2.05, 95 % CI: 1.68-2.51). Late TAVR was associated with longer hospital stay (11 days vs. 4 days, p < 0.01) and higher costs ($72,851 vs. $53,209, p < 0.01).

Early TAVR was conducted in approximately 25 % of the AS patients admitted with AHF, showing improved in-hospital outcomes before adjustment, with no significant differences observed after adjustment.

Transcatheter aortic valve implantation (TAVI) has become the standard of care for elderly patients with aortic stenosis. International guidelines recommend that TAVI should be performed only in centers with on-site cardiac surgery (CS). However, rapidly evolving TAVI technology and increasing operator expertise have significantly reduced peri-procedural complications, including those requiring rescue surgery, which occur in less than 0.5% of cases. Furthermore, only a minority of major complications are treated with CS, and the outcomes remain unfavorable. TAVI in centers without CS could represent a solution to reduce waiting times and ensure continuity of care for fragile patients. "TAVI at Home" is a single-arm prospective interventional study. According to sample size calculations based on literature data, the study aims to enroll a total of 200 patients, beginning with a run-in phase of 20 patients to establish safety. The primary endpoint is 30-day all-cause mortality. Secondary endpoints include technical success and the evaluation of single complications 30 days after the procedure. Hospitals without CS that are eligible to perform TAVI must have a high volume of coronary percutaneous interventions, operators with established TAVI experience, collaboration with vascular surgeons, and regular Heart Team meetings to ensure rigorous patient selection.

Coronary CT angiography (CCTA) is mandatory before transcatheter aortic valve replacement (TAVR). Our objective was to evaluate the efficacy of artificial intelligence (AI)-powered software in automatically analyzing cardiac parameters from pre-procedural CCTA to predict major adverse cardiovascular events (MACE) in TAVR patients.

Patients undergoing pre-TAVR CCTA were retrospectively included. AI software automatically extracted 34 morphologic and volumetric cardiac parameters characterizing the ventricles, atria, myocardium, and epicardial adipose tissue. Clinical information and outcomes were recorded from institutional database. Cox regression analysis identified predictors of MACE, including non-fatal myocardial infarction, heart failure hospitalization, unstable angina, and cardiac death. Model performance was evaluated with Harrell's C-index, and nested models were compared using the likelihood ratio test. Manual analysis of 170 patients assessed agreement with automated measurements.

Among the 648 enrolled patients (77 ± 9.3 years, 58.9% men), 116 (17.9%) experienced MACE within a median follow-up of 24 months (interquartile range 10-40). After adjusting for clinical parameters, only left ventricle long axis shortening (LV-LAS) was an independent predictor of MACE (hazard ratio [HR], 1.05 [95% confidence interval, 1.05-1.11]; p = 0.04), with significantly improved C-index (0.620 vs. 0.633; p < 0.001). When adjusted for the Society of Thoracic Surgeons Predicted Risk of Mortality score, LV-LAS was also predictive of MACE (HR, 1.08 [95%CI, 1.03-1.13]; p = 0.002), while improving model performance (C-index: 0.557 vs. 0.598; p < 0.001). All parameters showed good or excellent agreement with manual measurements.

Automated AI-based comprehensive cardiac assessment enables pre-TAVR MACE prediction, with LV-LAS outperforming all other parameters.

The impact of Aortic Stenosis (AS) on the left ventricle (LV) extends beyond the influence of the pressure drop across the stenotic valve, but also includes the additional serial afterload imposed by the vascular system. Aortic input impedance is the gold standard for comprehensively studying the contribution of the vascular system to total myocardial afterload, but in the past measurement has been challenging arising from the need for invasive catheterization or specialized equipment to precisely record time-resolved blood pressure and flow signals. The goal of this work was to develop and validate a novel simulation-based method for determining aortic input impedance using only clinically available echocardiographic data and a simple blood pressure measurement.

A simulation-based method to determine vascular impedance was developed using echocardiographic data and a brachial blood pressure measurement. Simulation-based impedance was compared to impedance calculated from echocardiographic flow data and pressure data from a non-invasive central pressure measurement device.

In validation analysis comparing patient-specific simulation-based vascular impedance to non-invasively measured impedance, correlation between methods across a range of vascular parameters varied between R2 = 0.40 and 0.99. A tendency was seen toward underestimation of pressure waveforms in point-by-point comparison of measured and simulated waveforms with an overall mean difference of 4.01 mmHg.

Requiring only non-invasive clinical data that are widely available, simulation-based vascular impedance has the potential to allow for easier, more widespread, and larger-scale investigation of the effect of vascular impedance on total LV afterload.

Maintaining functional status, defined as the ability to perform daily activities such as bathing, dressing, and preparing meals, is central to older adults' quality of life, health, and ability to remain independent. Identifying functional impairments - defined as having difficulty or needing help performing these activities - is essential for clinicians to provide optimal care to older adults, and on a population level, understanding function can help anticipate service needs. Yet uptake of standardized measurement of functional status into routine patient care has been slow and inconsistent due to the burden posed by current tools. The goal of the Patient-Aligned Care Team (PACT) Functional Status Screening Initiative is to implement and evaluate a patient-centered, low-burden intervention to improve identification and management of functional impairment among older veterans in Veterans Health Administration (VHA) primary care settings.

We will conduct a hybrid type 2 implementation-effectiveness cluster-randomized adaptive trial at 8 VHA sites using the Practical, Robust Implementation and Sustainability Model (PRISM) to guide implementation and evaluation. During a Pre-Implementation phase, we will engage clinical partners and develop local adaptations to maximize intervention-setting fit. During an Implementation phase, we will launch a standard bundle of implementation strategies (coalition building, champions, technical assistance) and system-level audit and feedback, identify sites with low uptake, and randomize those sites to receive continued standard vs. enhanced strategies (standard strategies plus clinician-level audit and feedback). The primary implementation outcome is reach (proportion of eligible patients at each site who receive screening/assessment) and the primary effectiveness outcome is appropriate management of impairment (proportion of patients with identified impairments who receive related referrals).

Implementing routine measurement of functional status in primary care has the potential to improve identification and management of functional impairment for older veterans. Improved management includes increasing access to services and supports for veterans and family caregivers, reducing potentially preventable acute care utilization, and allowing veterans to live in the least restrictive setting for as long as possible. Implementation will also provide data to inform the delivery of proactive interventions to prevent and delay development of functional impairment and improve quality of life, health, and independence.

Registered at ClinicalTrials.gov on May 7, 2024, at NCT06404970 ( https://clinicaltrials.gov/ ).

Standards for Reporting Implementation Studies (Additional file 1).

Background: There are limited data on the impact of right heart failure (RHF) on patients undergoing transcatheter aortic valve implantation (TAVI). We investigated the mortality, in-hospital complications, length of stay, and total hospitalization charges for TAVI admissions, with and without RHF. Methods: We analyzed the National Inpatient Sample data from 2018 to 2022. The International Classification of Diseases-Tenth Revision (ICD-10) codes were used to define the patient cohorts. Propensity score weighting was used to balance patient demographic, hospital-level, and comorbidity data. Results: From 2018 to 2022, there were 383,860 TAVI admissions, among which 1915 (0.50%) had the presence of RHF. Compared to patients without RHF, mortality was higher in patients with RHF (7.57% vs. 1.11%, p < 0.01). Similarly, acute kidney injury (37.10% vs. 8.56%, p < 0.01), respiratory failure (12.79% vs. 1.91%, p < 0.01), and use of mechanical circulatory support (11.48% vs. 0.83%, p < 0.01) was higher in the cohort with RHF. Median length of stay (7 days vs. 2 days, p < 0.01) and hospitalization charges ($257,239 vs. $180,501, p < 0.01) were higher in patients with RHF. Conclusions: In conclusion, we report that RHF is associated with increased mortality risk, complications, and resource utilization in patients undergoing TAVI. Right ventricular function should be a part of the evaluation for TAVI, given significantly elevated risks associated with its presence.

Due to prognostic uncertainty and limited decision-making capacity, the choice to perform transcatheter aortic valve implantation (TAVI) in patients with severe aortic stenosis (AS) and comorbid dementia is challenging. This study explores older adults' perspectives on complex decision-making preceding TAVI in the hypothetical setting of comorbid dementia.

Qualitative study entailing semistructured interviews. Analysis was by systematic text condensation. The interview guide addressed their attitudes regarding treatment dilemmas before TAVI in patients living with dementia.

Patients were recruited from the TAVI outpatient clinic at a university hospital performing TAVI.

A purposive sample of 10 older adults (5 women) with AS and without dementia (range 77-94 years), where 8/10 had undergone TAVI were included.

Three main challenges were identified: (1) Risk assessment. Participants found it hard to compare the burden of aortic stenosis vs dementia. They acknowledged the dilemma of implanting a new heart valve to achieve symptom relief while risking severe dementia in the future due to prolonged life span. (2) Autonomous capacity. A profound uncertainty was described regarding who should participate in decision-making if the person was incapacitated due to dementia. (3) Customised information. Participants advocated for thorough information describing facts and uncertainty, aiming to protect and support the person living with dementia.

Older adults with severe aortic stenosis find it hard relating to dilemmas arising from providing TAVI in patients living with dementia. There is a need for tailor-made information to support autonomy and decision-making under uncertainty.

Inflammatory changes in epicardial (EAT) and pericardial adipose tissue (PAT) are associated with increased overall cardiovascular risk. Using routine, preinterventional cardiac CT data, we examined the predictive value of quantity and quality of EAT and PAT for outcome after transcatheter aortic valve replacement (TAVR).

Cardiac CT data of 1197 patients who underwent TAVR at the in-house heart center between 2011 and 2020 were retrospectively analyzed. The amount and density of EAT and PAT were quantified from single-slice CT images at the level of the aortic valve. Using established risk scores and known independent risk factors, a clinical benchmark model (BMI, Chronic kidney disease stage, EuroSCORE 2, STS Prom, year of intervention) for outcome prediction (2-year mortality) after TAVR was established. Subsequently, we tested whether the additional inclusion of area and density values of EAT and PAT in the clinical benchmark model improved prediction. For this purpose, the cohort was divided into a training (n=798) and a test cohort (n=399).

Within the 2-year follow-up, 264 patients died. In the training cohort, particularly the addition of EAT density to the clinical benchmark model showed a significant association with outcome (hazard ratio 1.04, 95% CI: 1.01-1.07; P =0.013). In the test cohort, the outcome prediction of the clinical benchmark model was also significantly improved with the inclusion of EAT density (c-statistic: 0.589 vs. 0.628; P =0.026).

EAT density as a surrogate marker of EAT inflammation was associated with 2-year mortality after TAVR and may improve outcome prediction independent of established risk parameters.

Patients undergoing transcatheter aortic valve implantation (TAVI) have a high comorbidity burden. We sought to stratify patients into functional outcomes using the Kansas City Cardiomyopathy Questionnaire (KCCQ-12), a patient-reported outcome with benefits over both the New York Heart Association (NYHA) classification and the original 23-item KCCQ, and to evaluate the importance of comorbidities in predicting failure of functional improvement post-TAVI in a contemporary cohort.

In total, 366 patients with severe aortic stenosis undergoing TAVI with baseline KCCQ-12 were retrospectively analysed and divided into two groups. Failure to improve was defined as a score <60 and a change in score <10 at 1 year in either overall score (KCCQ-OS) or clinical summary score (KCCQ-CSS).

Failure to improve was noted in 13% of patients, who were more likely to have lower KCCQ-OS at baseline (47 [35-59] vs 56 [42-74]), chronic obstructive pulmonary disease (COPD) (19% vs 8%), severe chronic kidney disease (CKD) (13% vs 2%), a clinical frailty score (CFS) ≥5 (41% vs 14%), and lower serum albumin (36 g/L [34-38] vs 38 g/L [35-40]). On multivariate analysis, with an area under the curve of 0.71 (0.63-0.78), baseline KCCQ-OS (adjusted odds ratio [aOR] 0.3 [0.1-0.6], p=0.04), COPD (aOR 2.8 [1.2-6.5], p=0.02), and severe CKD (aOR 5.7 [1.7-18.5], p=0.004) remained independent predictors. CFS alone had a similar predictive value as the multivariable model (OR 2.0 [1.3-3.4], area under the curve 0.69 [0.59-0.80], p<0.001).

KCCQ scores were effective in delineating functional outcomes, with most patients in our relatively lower surgical risk cohort showing significant functional improvements post-TAVI. Low baseline KCCQ, moderate or worse COPD, and severe CKD were associated with failure of improvement post-TAVI. Baseline CFS appears to be a good screening tool to predict poor improvement. These factors should be evaluated and weighted accordingly in pre-TAVI assessments and decision-making.

Despite its importance for clinical care and outcomes among older adults, functional status-the ability to perform basic activities of daily living (ADLs) and instrumental ADLs (IADLs)-is seldom routinely measured in primary care settings. The objective of this study was to pilot test a person-centered, interprofessional intervention to improve identification and management of functional impairment among older adults in Veterans Affairs (VA) primary care practices. The four-component intervention included (1) an interprofessional educational session; (2) routine, standardized functional status measurement among patients aged ≥75; (3) annual screening by nurses using a standardized instrument and follow-up assessment by primary care providers; and (4) electronic tools and templates to facilitate increased identification and improved management of functional impairment. Surveys, semi-structured interviews, and electronic health record data were used to measure implementation outcomes (appropriateness, acceptability and satisfaction, feasibility, fidelity, adoption/reach, sustainability). We analyzed qualitative interviews using rapid qualitative analysis. During the study period, all 959 eligible patients were screened (100% reach), of whom 7.3% (n = 58) reported difficulty or needing help with ≥1 ADL and 11.8% (n = 113) reported difficulty or needing help with ≥1 IADL. In a chart review among a subset of 50 patients with functional impairment, 78% percent of clinician notes for the visit when screening was completed had content related to function, and 48% of patients had referrals ordered to address impairments (e.g., physical therapy) within 1 week. Clinicians highly rated the quality of the educational session and reported increased ability to measure and communicate about function. Clinicians and patients reported that the intervention was appropriate, acceptable, and feasible to complete, even during the COVID pandemic. These findings suggest that this intervention is a promising approach to improve identification and management of functional impairment for older patients in primary care. Broader implementation and evaluation of this intervention is currently underway.

Little is known about the methods and outcomes of patient-reported outcome measure (PROM) use among high-risk medical device registries. The objective of this scoping review was to assess the utility and predictive ability of PROMs in high-risk medical device registries. We searched Ovid Medline, Embase, APA PsychINFO, Cochrane Library, and Scopus databases for published literature. After searching, 4323 titles and abstracts were screened, and 262 full texts were assessed for their eligibility. Seventy-six papers from across orthopedic (n = 64), cardiac (n = 10), penile (n = 1), and hernia mesh (n = 1) device registries were identified. Studies predominantly used PROMs as an outcome measure when comparing cohorts or surgical approaches (n = 45) or to compare time points (n = 13) including pre- and postintervention. Fifteen papers considered the predictive ability of PROMs. Of these, 8 treated PROMs as an outcome, 5 treated PROMs as a risk factor through regression analysis, and 2 papers treated PROMs as both a risk factor and as an outcome. One paper described PROMs to study implant survival. To advance methods of PROM integration into clinical decision-making for medical devices, an understanding of their use in high-risk device registries is needed. This scoping review found that there is a paucity of studies using PROMs to predict long-term patient and clinical outcomes in high-risk medical device registries. Determination as to why PROMs are rarely used for predictive purposes in long-term data collection is needed if PROM data are to be considered suitable as real-world evidence for high-risk device regulatory purposes, as well as to support clinical decision-making.

Diastolic dysfunction (DD) is a long-established marker of disease progression in patients with aortic valve stenosis (AS), indicating valvular myocardial damage. Recently, substantial observational data have emerged demonstrating that worse pre-operative DD assessed using echocardiography is associated with adverse long-term clinical outcomes after transcatheter aortic valve replacement (TAVR).

To systematically appraise and quantitatively synthesize current evidence on the prognostic impact of echocardiographic severe DD derived by echocardiography before TAVR.

A systemic literature review was undertaken in electronic databases to identify studies reporting the predictive value of severe DD in AS subjects undergoing TAVR. A random-effects meta-analysis was conducted to quantify the adjusted and unadjusted hazard ratios (HRs) for all-cause mortality and major adverse cardiovascular events (MACEs) for the presence of severe DD.

Ten studies were deemed eligible for inclusion. Of those, 9 provided appropriate quantitative data for the meta-analysis, encompassing a total of 4,619 patients. The presence of severe DD was associated with increased risk for all-cause mortality (pooled unadjusted HR=2.56 [1.46-4.48]; p<0.01; I2=76 %) and MACEs (pooled unadjusted HR=1.82 [1.29-2.58]; p<0.01; I2=86 %). When adjusted for clinically-relevant parameters, the presence of severe DD retained independent association with all-cause mortality (pooled adjusted HR=2.35 [1.26-4.37]; p<0.01; I2=79 %) and MACEs (pooled adjusted HR= 2.52 [1.72-3.65]; p<0.01; I2=0 %). In subgroup analysis there was no difference on post-TAVR risk between the use of different diastolic function grading scores.

Presence of severe DD assessed by echocardiography pre-TAVR is a major determinant of long-term adverse outcomes after the procedure.

The aim of this study was to identify phenotypes with potential prognostic significance in aortic stenosis (AS) patients after transcatheter aortic valve replacement (TAVR) through a clustering approach.

This multi-centre retrospective study included 1365 patients with severe AS who underwent TAVR between January 2015 and March 2019. Among demographics, laboratory, and echocardiography parameters, 20 variables were selected through dimension reduction and used for unsupervised clustering. Phenotypes and outcomes were compared between clusters. Patients were randomly divided into a derivation cohort (n = 1092: 80%) and a validation cohort (n = 273: 20%). Three clusters with markedly different features were identified. Cluster 1 was associated predominantly with elderly age, a high aortic valve gradient, and left ventricular (LV) hypertrophy; Cluster 2 consisted of preserved LV ejection fraction, larger aortic valve area, and high blood pressure; and Cluster 3 demonstrated tachycardia and low flow/low gradient AS. Adverse outcomes differed significantly among clusters during a median of 2.2 years of follow-up (P < 0.001). After adjustment for clinical and echocardiographic data in a Cox proportional hazards model, Cluster 3 (hazard ratio, 4.18; 95% confidence interval, 1.76-9.94; P = 0.001) was associated with increased risk of adverse outcomes. In sequential Cox models, a model based on clinical data and echocardiographic variables (χ2 = 18.4) was improved by Cluster 3 (χ2 = 31.5; P = 0.001) in the validation cohort.

Unsupervised cluster analysis of patients after TAVR revealed three different groups for assessment of prognosis. This provides a new perspective in the categorization of patients after TAVR that considers comorbidities and extravalvular cardiac dysfunction.

Up to one-fifth of patients continue to have poor quality of life after transcatheter aortic valve implantation (TAVI), with an additional similar proportion not surviving 1 year after the procedure. We aimed to assess the value of a new method based on an integrated analysis of left ventricular outflow tract flow velocity and aortic pressure to predict objective functional improvement and prognosis after TAVI.

In a cohort of consecutive patients undergoing TAVI, flow velocity-pressure integrated analysis was obtained from simultaneous pressure recordings in the ascending aorta and flow velocity recordings in the left ventricular outflow tract by echocardiography. Objective functional improvement 6 months after TAVI was assessed through changes in a 6-min walk test and NT-proBNP levels. A clinical follow-up was conducted at 2 years.

Of the 102 patients studied, 82 (80.4%) showed objective functional improvement. The 2-year mortality of these patients was significantly lower (9% vs. 44%, p = 0.001). In multivariate analysis, parameter "(Pressure at Vmax - Pressure at Vo)/Vmax" was found to be an independent predictor for objective improvement. The C-statistic was 0.70 in the overall population and 0.78 in the low-gradient subgroup. All echocardiographic parameters and the valvuloarterial impedance showed a C-statistic of <0.6 for the overall and low-gradient patients. In a validation cohort of 119 patients, the C-statistic was 0.67 for the total cohort and 0.76 for the low-gradient subgroup.

This new method allows predicting objective functional improvement after TAVI more precisely than the conventional parameters used to assess the severity of aortic stenosis, particularly in low-gradient patients.

Prior studies of aortic valve replacement (AVR) in patients with normal-flow, low-gradient aortic stenosis (NF-LG AS) have demonstrated conflicting results regarding the survival benefit of AVR. Changes in quality of life (QoL) after transcatheter AVR (TAVR) have not been reported in this population.

The purpose of this study was to compare changes in QoL after TAVR for patients with NF-LG AS to patients with high-gradient aortic stenosis (HG-AS).

Patients who underwent TAVR for severe aortic stenosis (AS) were divided into 4 hemodynamic profiles of AS, including NF-LG AS. Changes in Kansas City Cardiomyopathy Questionnaire-12 score from baseline to 1 year were compared between AS groups. The primary composite outcome indicating clinical improvement consisted of survival to 1 year and improved Kansas City Cardiomyopathy Questionnaire overall summary score of ≥5 points while adjusting for relevant baseline factors.

Out of 860 patients who underwent TAVR, high gradient AS was present in 368 (42.8%) patients and NF-LG AS in 245 (28.5%). HG-AS and NF-LG AS groups had a similar proportion of patients who met the primary unadjusted outcome of clinical improvement (70.4% vs 63.9%, respectively; P = 0.189). One-year Kaplan-Meier mortality estimates were higher for NF-LG AS patients than HG-AS patients (12.9% vs 5.8%, P < 0.001). In the primary adjusted analysis, there was no significant difference in the composite outcome between HG and NF-LG AS groups (adjusted OR: 0.72, 95% CI: 0.47-1.11).

Selected patients with NF-LG AS experienced similar improvement in QoL after TAVR compared with HG-AS. Further investigation of patients with NF-LG AS will help to inform optimal selection for treatment with TAVR.

Severe aortic stenosis (AS) carries a poor prognosis with the onset of heart failure (HF) symptoms, and surgical or transcatheter aortic valve replacement (AVR) is its only definitive treatment. The management of AS has seen a paradigm shift with the adoption of transcatheter aortic valve replacement (TAVR), allowing for the treatment of AS in patients who would not otherwise be candidates for surgical AVR. Despite improving long-term survival after TAVR in recent years, residual HF symptoms and HF hospitalization are common and are associated with an increased mortality and a poor health status. This review article summarizes the incidence and risk factors for HF after AVR. Strategies for preventing and better managing HF after AVR are necessary to improve outcomes in this patient population. Extensive research is underway to assess whether earlier timing for AVR, prior to the development of severe symptomatic AS and associated extra-valvular cardiac damage, can improve post-AVR patient outcomes.

Functional status, or the ability to perform activities of daily living, is central to older adults' health and quality of life. However, health systems have been slow to incorporate routine measurement of function into patient care. We used multiple qualitative methods to develop a patient-centered, interprofessional intervention to improve measurement of functional status for older veterans in primary care settings. We conducted semi-structured interviews with patients, clinicians, and operations staff (n = 123) from 7 Veterans Health Administration (VHA) Medical Centers. Interviews focused on barriers and facilitators to measuring function. We used concepts from the Consolidated Framework for Implementation Science and sociotechnical analysis to inform rapid qualitative analyses and a hybrid deductive/inductive approach to thematic analysis. We mapped qualitative findings to intervention components. Barriers to measurement included time pressures, cumbersome electronic tools, and the perception that measurement would not be used to improve patient care. Facilitators included a strong interprofessional environment and flexible workflows. Findings informed the development of five intervention components, including (1) an interprofessional educational session; (2) routine, standardized functional status measurement among older patients; (3) annual screening by nurses using a standardized instrument and follow-up assessment by primary care providers; (4) electronic tools and templates to facilitate increased identification and improved management of functional impairment; and (5) tailored reports on functional status for clinicians and operations leaders. These findings show how qualitative methods can be used to develop interventions that are more responsive to real-world contexts, increasing the chances of successful implementation. Using a conceptually-grounded approach to intervention development has the potential to improve patient and clinician experience with measuring function in primary care.

Depression and cognitive dysfunction (CD) are not routinely screened for in patients before transcatheter aortic valve replacement (TAVR) and their association with postprocedural outcomes is poorly understood. The objectives of this study are to determine the prevalence of depression and CD in patients with aortic stenosis undergoing TAVR and evaluate their association with mortality and quality of life.

We analyzed a prospective, multicenter TAVR registry that systematically screened patients for preexisting depression and CD with the Patient Health Questionnaire-2 and Mini-Cog, respectively. The associations with mortality were assessed with Cox proportional hazard models and quality of life (Kansas City Cardiomyopathy Questionnaire and EuroQol visual analogue scale) were evaluated using multivariable ordinal regression models.

A total of 884 patients were included; median follow-up was 2.88 years (interquartile range=1.2-3.7). At baseline, depression was observed in 19.6% and CD in 31.8%. In separate models, after adjustment, depression (HR, 1.45 [95% CI, 1.13-1.86]; P<0.01) and CD (HR, 1.27 [95% CI, 1.02-1.59]; P=0.04) were each associated with increased mortality. Combining depression and CD into a single model, mortality was greatest among those with both depression and CD (n=62; HR, 2.06 [CI, 1.44-2.96]; P<0.01). After adjustment, depression was associated with 6.6 (0.3-13.6) points lower on the Kansas City Cardiomyopathy Questionnaire 1-year post-TAVR and 6.7 (0.5-12.7) points lower on the EuroQol visual analogue scale. CD was only associated with lower EuroQol visual analogue scale.

Depression and CD are common in patients that undergo TAVR and are associated with increased mortality and worse quality of life. Depression may be a modifiable therapeutic target to improve outcomes after TAVR.

Severe chronic obstructive pulmonary disease (COPD) has been associated with futile outcome after transcatheter aortic valve replacement (TAVR). Data on outcomes according to COPD severity are warranted to aid identification of patients who may not benefit from TAVR. We aimed to examine the association between risk of COPD exacerbation and 1-year mortality after TAVR.

Using Danish nationwide registries we identified patients undergoing first-time TAVR during 2008-2021 by COPD status. COPD severity levels were defined as low or high risk of acute exacerbation of COPD (AE-COPD) and treatment intensity levels (none or short-term, mono/dual, triple therapy, or home oxygen). Kaplan-Meier functions and adjusted Cox regression models were used to assess 1-year mortality comparing COPD severity groups with patients without COPD.

We identified 7,047 patients with TAVR of whom 644 had a history of COPD (low risk of AE-COPD: 439, high risk of AE-COPD: 205). The median age of the TAVR cohort was 81.4 years (IQR: 76.8-85.1) and 55.8% were males. One-year mortality for TAVR patients without COPD was 8.5% (95% CI: 7.8-9.2) and 15.4% (95% CI: 12.5-18.2) for those with COPD (adjusted HR: 1.63 [95% CI: 1.28-2.07]). Patients with low or high risk of AE-COPD had 1-year mortality of 13.1% (95% CI: 9.8-16.3) and 20.2% (95% CI: 14.6-25.8) corresponding to adjusted HRs of 1.31 (95% CI: 0.97-1.78) and 2.44 (95% CI: 1.70-3.50) compared with patients without COPD. Patients with high risk of AE-COPD and no/short term therapy or use of home oxygen represented the subgroups of patients with the highest 1-year mortality (31.6% [95% CI: 14.5-48.7] and 30.9% [95% CI: 10.3-51.6]).

Among patients undergoing TAVR, increasing risk of exacerbation with COPD was associated with increasing 1-year mortality compared with non-COPD patients. Patients with a high risk of exacerbation with COPD not using any guideline recommended COPD medication and those using home oxygen had the highest 1-year mortality.

The extent of extravalvular cardiac damage is associated with increased risk of adverse events among patients with severe aortic stenosis undergoing aortic valve replacement (AVR).

The goal was to describe the association of cardiac damage on health status before and after AVR.

Patients from the PARTNER (Placement of Aortic Transcatheter Valves) 2 and 3 trials were pooled and classified by echocardiographic cardiac damage stage at baseline and 1 year as previously described (stage 0-4). We examined the association between baseline cardiac damage and 1-year health status (assessed by the Kansas City Cardiomyopathy Questionnaire Overall Score [KCCQ-OS]).

Among 1,974 patients (794 surgical AVR, 1,180 transcatheter AVR), the extent of cardiac damage at baseline was associated with lower KCCQ scores both at baseline and at 1 year after AVR (P < 0.0001) and with increased rates of a poor outcome (death, KCCQ-OS <60, or a decrease in KCCQ-OS of ≥10 points) at 1 year (stages 0-4: 10.6% vs 19.6% vs 29.0% vs 44.7% vs 39.8%; P < 0.0001). In a multivariable model, each 1-stage increase in baseline cardiac damage was associated with a 24% increase in the odds of a poor outcome (95% CI: 9%-41%; P = 0.001). Change in stage of cardiac damage at 1 year after AVR was associated with the extent of improvement in KCCQ-OS over the same period (mean change in 1-year KCCQ-OS: improvement of ≥1 stage +26.8 [95% CI: 24.2-29.4] vs no change +21.4 [95% CI: 20.0-22.7] vs deterioration of ≥1 stage +17.5 [95% CI: 15.4-19.5]; P < 0.0001).

The extent of cardiac damage before AVR has an important impact on health status outcomes, both cross-sectionally and after AVR. (PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk (PII A), NCT01314313; The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII B [PARTNERII B], NCT02184442; PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis [P3], NCT02675114).

The approved use of transcatheter aortic valve replacement (TAVR) for aortic stenosis has expanded substantially over time. However, gaps remain with respect to accurately delineating risk for poor clinical and patient-centered outcomes. Our objective was to develop prediction models for 30-day clinical and patient-centered outcomes after TAVR within a large, diverse community-based population.

We identified all adults who underwent TAVR between 2013-2019 at Kaiser Permanente Northern California, an integrated healthcare delivery system, and were monitored for the following 30-day outcomes: all-cause death, improvement in quality of life, all-cause hospitalizations, all-cause emergency department (ED) visits, heart failure (HF)-related hospitalizations, and HF-related ED visits. We developed prediction models using gradient boosting machines using linked demographic, clinical and other data from the Society for Thoracic Surgeons (STS)/American College of Cardiology (ACC) TVT Registry and electronic health records. We evaluated model performance using area under the curve (AUC) for model discrimination and associated calibration plots. We also evaluated the association of individual predictors with outcomes using logistic regression for quality of life and Cox proportional hazards regression for all other outcomes.

We identified 1,565 eligible patients who received TAVR. The risks of adverse 30-day post-TAVR outcomes ranged from 1.3% (HF hospitalizations) to 15.3% (all-cause ED visits). In models with the highest discrimination, discrimination was only moderate for death (AUC 0.60) and quality of life (AUC 0.62), but better for HF-related ED visits (AUC 0.76). Calibration also varied for different outcomes. Importantly, STS risk score only independently predicted death and all-cause hospitalization but no other outcomes. Older age also only independently predicted HF-related ED visits, and race/ethnicity was not significantly associated with any outcomes.

Despite using a combination of detailed STS/ACC TVT Registry and electronic health record data, predicting short-term clinical and patient-centered outcomes after TAVR remains challenging. More work is needed to identify more accurate predictors for post-TAVR outcomes to support personalized clinical decision making and monitoring strategies.

A non-negligible rate of patients undergoing transcatheter aortic valve replacement (TAVR) do not report symptomatic improvement or even die in the short-midterm. We sought to assess the degree of objective functional recovery after TAVR and its prognostic implications and to develop a predictive model.

In a cohort of patients undergoing TAVR, a prospective evaluation of clinical, anatomical, and physiological parameters was conducted before and after the procedure. These parameters were derived from echocardiography, non-invasive analysis of arterial pulse waves, and cardiac tomography. Objective functional improvement 6 months after TAVR was assessed using a 6-min walk test and nitro-terminal pro-brain natriuretic peptide (NT-proBNP) levels. The derived predictive model was prospectively validated in a different cohort. A clinical follow-up was conducted at 2 years.

Among the 212 patients included, objective functional improvement was observed in 169 patients (80%) and subjective improvement in 187 (88%). Patients with objective functional improvement showed a much lower death rate at 2 years (9% vs. 31% p = 0.0002). Independent predictors of improvement were as follows: mean aortic gradient of ≥40 mmHg, augmentation index₇₅ of ≥45%, the posterior wall thickness of ≤12 mm, and absence of atrial fibrillation. A simple integer-based point score was developed (GAPA score), which showed an area under the curve of 0.81 for the overall cohort and 0.78 for the low-gradient subgroup. In a validation cohort of 216 patients, these values were 0.75 and 0.76, respectively.

A total of 80% of patients experienced objective functional improvement after TAVR, showing a significantly lower 2-year mortality rate. A predictive score was built that showed a good discriminative performance in overall and low-gradient populations.

Geriatric cardiology involves providing cardiovascular care to older adults in relation to aging. Although cardiovascular diseases are the most common diseases faced by older adults, they often co-occur with numerous aging-related challenges, such as multimorbidity, frailty, polypharmacy, falls, functional and cognitive impairment, which present challenges to implementing standard disease-based treatment strategies. Faced with these complexities, patient-centered care in geriatric cardiology strives to direct all management toward the achievement of an individual's prioritized health and life goals by employing shared decision-making to align treatment with goals, utilizing stated goals to navigate situations of treatment uncertainty, and pro-actively mitigating aging-related risks. This fundamental change in cardiovascular medicine from disease-centered management to patient-centered goal-directed care is necessary to facilitate wellness, independence, and favorable quality of life outcomes in the older adult population.

Limited data exist regarding the association between the quality of life (QoL) and clinical outcomes following transcatheter mitral valve repair (TMVr). We aimed to evaluate the prognostic significance of QoL assessment following TMVr and to characterize those who had procedural success, yet reported a low Kansas City Cardiomyopathy Questionnaire (KCCQ-12) score.

We reported the experience of Cedars-Sinai Medical Center patients between 2013 and 2020. Patients were allocated into four groups according to the 30-day KCCQ: <25, 25-49, 50-74, and ≥75. Primary outcome included 1-year all-cause death or heart failure (HF) hospitalizations. We also examined the association between QoL and the primary outcome in those with procedural success.

A total of 555 patients were included in our analysis, median follow-up of 650 days (IQR 243-1113). The lower KCCQ groups had a higher prevalence of functional mitral regurgitation (65%, 60%, 56%, and 43%, p = 0.001), as well as a higher Society of Thoracic Surgeon (STS) score. These groups had a significantly higher occurrence of 1-year all-cause death or HF hospitalizations in a stepwise fashion (40%, 22%, 16%, and 10%, p < 0.001). Multivariable Cox regression analysis revealed 30-day KCCQ as the strongest predictor of the 1-year primary outcome (HR 0.98, 95%CI (0.97-0.99), p = 0.006). Approximately a quarter of patients with procedural success had a low KCCQ score. These patients had a higher rate of the combined 1-year outcome regardless of procedural success or failure.

QoL following TMVr is a powerful prognostic factor. KCCQ assessment is an important indicator for identifying patients prone to adverse outcomes even after procedural success.

Patients with non-paradoxical low-flow-low-gradient (LFLG) aortic stenosis (AS) are at increased surgical risk, and thus, they may particularly benefit from transcatheter aortic valve replacement (TAVR). However, data on this issue are still limited and based on the results with older-generation transcatheter heart valves (THVs). The aim of this study was to investigate early and mid-term outcome of TAVR with newer-generation THVs in the setting of LFLG AS. Data for the present analysis were gathered from the OBSERVANT II dataset, a national Italian observational, prospective, multicenter cohort study that enrolled 2,989 consecutive AS patients who underwent TAVR at 30 Italian centers between December 2016 and September 2018, using newer-generation THVs. Overall, 420 patients with LVEF ≤50% and mean aortic gradient <40 mmHg were included in this analysis. The primary outcomes were 1-year all-cause mortality and a combined endpoint including all-cause mortality and hospital readmission due to congestive heart failure (CHF) at 1 year. A risk-adjusted analysis was performed to compare the outcome of LFLG AS patients treated with TAVR (n = 389) with those who underwent surgical aortic valve replacement (SAVR, n = 401) from the OBSERVANT I study. Patients with LFLG AS undergoing TAVR were old (mean age, 80.8 ± 6.7 years) and with increased operative risk (mean EuroSCORE II, 11.5 ± 10.2%). VARC-3 device success was 83.3% with 7.6% of moderate/severe paravalvular leak. Thirty-day mortality was 3.1%. One-year all-cause mortality was 17.4%, and the composite endpoint was 34.8%. Chronic obstructive pulmonary disease (HR 1.78) and EuroSCORE II (HR 1.02) were independent predictors of 1-year mortality, while diabetes (HR 1.53) and class NYHA IV (HR 2.38) were independent predictors of 1-year mortality or CHF. Compared with LFLG AS treated with SAVR, TAVR patients had a higher rate of major vascular complications and permanent pacemaker, while SAVR patients underwent more frequently to blood transfusion, cardiogenic shock, AKI, and MI. However, 30-day and 1-year outcomes were similar between groups. Patients with non-paradoxical LFLG AS treated by TAVR were older and with higher surgical risk compared with SAVR patients. Notwithstanding, TAVR was safe and effective with a similar outcome to SAVR at both early and mid-term.

This study sought to evaluate patient-centered metrics in intermediate-surgical-risk aortic stenosis patients enrolled in the SURTAVI (Surgical Replacement and Transcatheter Aortic Valve Implantation) trial treated with self-expanding transcatheter aortic valve replacement (TAVR) or surgery.

Studies have shown TAVR to be an alternative to surgery in patients with severe symptomatic aortic stenosis but have focused on "hard endpoints," including all-cause mortality and stroke, rather than on comparative patient-centered metrics, such as functional status and symptom burden.

The study analyzed functional status (6-minute walk test [6MWT]) and symptom burden (Kansas City Cardiomyopathy Questionnaire) in 1,492 patients from the SURTAVI trial at baseline, 30 days, 1 year, and 2 years. Patients were categorized by baseline functional status into tertiles of slow, medium, and fast walkers.

Patients with lowest capacity baseline functional status were commonly women, had higher Society of Thoracic Surgeons scores, and had more New York Heart Association functional class III or IV symptoms; reduced baseline functional status was associated with higher aortic valve- and heart failure-related hospitalization at 2 years. There was greater improvement in 6MWT distance in TAVR compared with surgery patients at 30 days (P < 0.001) and 1 year (P = 0.012), but at 2 years, both groups had similar improvement (P = 0.091). The percentage of patients with large improvement in 6MWT was greatest in patients categorized as slow walkers and lowest in fast walkers. Symptom burden improved after TAVR at 30 days and after both procedures at 1 and 2 years.

In this substudy of patients from the SURTAVI trial, patients receiving TAVR demonstrated a more rapid improvement in functional status and symptom burden compared with patients undergoing surgery; however, both groups had similar improvements in long-term follow-up. (Safety and Efficacy Study of the Medtronic CoreValve® System in the Treatment of Severe, Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement [SURTAVI]; NCT01586910).