Impact of Neighborhood Social Deprivation on Delays to Access for Transcatheter Aortic Valve Replacement: Wait-Times and Clinical Consequences.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) has become the standard of care for severe aortic stenosis treatment. Exponential growth in demand has led to prolonged wait times and adverse patient outcomes. Social marginalization may contribute to adverse outcomes. Our objective was to examine the association between different measures of neighborhood-level marginalization and patient outcomes while on the TAVR waiting list. A secondary objective was to understand if sex modifies this relationship. METHODS AND RESULTS: We conducted a population-based retrospective cohort study of 11 077 patients in Ontario, Canada, referred to TAVR from April 1, 2018, to March 31, 2022. Primary outcomes were death or hospitalization while on the TAVR wait-list. Using cause-specific Cox proportional hazards models, we evaluated the relationship between neighborhood-level measures of dependency, residential instability, material deprivation, and ethnic and racial concentration with primary outcomes as well as the interaction with sex. After multivariable adjustment, we found a significant relationship between individuals living in the most ethnically and racially concentrated areas (quintile 4 and 5) and mortality (hazard ratio [HR], 0.64 [95% CI, 0.47-0.88] and HR, 0.73 [95% CI, 0.53-1.00], respectively). There was no significant association between material deprivation, dependency, or residential instability with mortality. Women in the highest ethnic or racial concentration quintiles (4 and 5) had significantly lower risks for mortality (HR values of 0.52 and 0.56, respectively) compared with quintile 1. CONCLUSIONS: Higher neighborhood ethnic or racial concentration was associated with decreased risk for mortality, particular for women on the TAVR waiting list. Further research is needed to understand the drivers of this relationship.

Cardiac Health Assessment Using a Wearable Device Before and After Transcatheter Aortic Valve Implantation: Prospective Study.

Background: Due to aging of the population, the prevalence of aortic valve stenosis will increase drastically in upcoming years. Consequently, transcatheter aortic valve implantation (TAVI) procedures will also expand worldwide. Optimal selection of patients who benefit with improved symptoms and prognoses is key, since TAVI is not without its risks. Currently, we are not able to adequately predict functional outcomes after TAVI. Quality of life measurement tools and traditional functional assessment tests do not always agree and can depend on factors unrelated to heart disease. Activity tracking using wearable devices might provide a more comprehensive assessment. Objective: This study aimed to identify objective parameters (eg, change in heart rate) associated with improvement after TAVI for severe aortic stenosis from a wearable device. Methods: In total, 100 patients undergoing routine TAVI wore a Philips Health Watch device for 1 week before and after the procedure. Watch data were analyzed offline-before TAVI for 97 patients and after TAVI for 75 patients. Results: Parameters such as the total number of steps and activity time did not change, in contrast to improvements in the 6-minute walking test (6MWT) and physical limitation domain of the transformed WHOQOL-BREF questionnaire. Conclusions: These findings, in an older TAVI population, show that watch-based parameters, such as the number of steps, do not change after TAVI, unlike traditional 6MWT and QoL assessments. Basic wearable device parameters might be less appropriate for measuring treatment effects from TAVI.

Hydrodynamic Assessment of Explanted Degenerated Transcatheter Aortic Valves: Novel Insights Into Noncalcific and Calcific Mechanisms.

BACKGROUND: The etiology of transcatheter aortic valve (TAV) degeneration is poorly understood, particularly noncalcific mechanisms. OBJECTIVES: The authors sought to investigate noncalcific and calcific mechanisms of TAV degeneration and evaluate their impact on leaflet function by bench testing, imaging, and histology. METHODS: TAV explants were obtained from the EXPLANT THV registry and clinical institutions. Hydrodynamic assessment was performed using a heart valve pulse duplicator system under physiological conditions. Micro-computed tomography, high-resolution photography, high speed video, and hematoxylin and eosin staining were used to evaluate the morphological appearance, leaflet kinematics, and calcium burden of TAVs. RESULTS: A total of 14 explants were evaluated: 10 self-expanding CoreValve/Evolut TAVs (Medtronic), 3 balloon-expandable SAPIEN 3 TAVs (Edwards Lifesciences), and 1 mechanically expandable Lotus TAV (Boston Scientific). The median patient age at explantation was 73.0 years (Q1-Q3: 64.5-80.0 years), with a time to explantation of 4 years 1 month (1 year 5 months to 4 years 11 months). Six TAV explants were found to have leaflet calcification (162.4 mm3; 58.8-603.0 mm3), and 8 had no calcification detectable by micro-computed tomography and histology. All samples had impaired leaflet kinematics. There was no significant difference in the hydrodynamic mean gradient between calcified (47.2 mm Hg; 26.6-74.1 mm Hg) and noncalcified (27.6 mm Hg; 15.2-36.7 mm Hg; P = 0.28) TAVs. Leaflet calcification had a weak but nonsignificant association with the hydrodynamic mean gradient (r = 0.42; P = 0.14). CONCLUSIONS: TAV function can be severely impacted by noncalcific and calcific mechanisms of tissue degeneration. Importantly, functional stenosis can occur in TAVs in the absence of obvious and significant calcification.

Trends and predictors of inflation-adjusted costs in transcatheter and surgical aortic valve replacement in a nationally representative sample.

BACKGROUND: Transcatheter aortic valve replacement has become an accepted alternative to surgical aortic valve replacement. We examined the trends and predictors in inflation-adjusted costs of transcatheter aortic valve replacement and surgical aortic valve replacement. METHODS: National Inpatient Sample identified patients who underwent aortic valve replacement for severe aortic stenosis by International Classification of Diseases, Ninth and Tenth Revisions, codes. Hospitalization costs were inflation-adjusted using the Federal Reserve's consumer price index to reflect current valuation. Outcomes of interest were unadjusted trend in annual cost for each procedure and predictors of in-patient cost. Generalized linear models with a log link function identified predictors of adjusted costs. Interaction terms determined where cost predictors were different by operation type. RESULTS: Between 2011 and 2019, the mean annual inflation-adjusted cost of surgical aortic valve replacement increased from $62,853 to $63,743, in contrast to decreasing cost of transcatheter aortic valve replacement from $64,913 to $56,042 ($1,854 per year; P = .004). Significant independent predictors of patient-level cost included operation type (transcatheter aortic valve replacement associated with $9,625 increase; P < .001), incidence of in-hospital mortality ($28,836 increase; P < .001), elective status ($2,410 decrease; P < .001), Elixhauser Index ($995 increase; P < .001), and postoperative length of stay ($2,014 per day increase; P < .001). Compared to discharges with Medicare, discharges with private insurance and Medicaid paid $736 less (P = .004) and $1,863 less (P = .01), respectively. Increasing hospital volume was a significant predictor of decreasing patient level cost (P < .001). CONCLUSION: Annual cost of transcatheter aortic valve replacement has decreased significantly and has been a more cost-effective modality compared to surgical aortic valve replacement since 2017. Predictors of patient-level costs allow for mindful preparation of healthcare systems for aortic valve replacement.

Sex-Specific Differences in Upstream Cardiac Damage in Patients With Aortic Stenosis Undergoing TAVR.

BACKGROUND: Cardiac damage caused by aortic stenosis (AS) can be categorized into stages, which are associated with a progressively increasing risk of death after transcatheter aortic valve replacement (TAVR). OBJECTIVES: The authors investigated sex-related differences in cardiac damage among patients with symptomatic AS and the prognostic value of cardiac damage classification in women and men undergoing TAVR. METHODS: In a prospective registry, pre-TAVR echocardiograms were used to categorize patients into 5 stages of cardiac damage caused by AS. Differences in the extent of cardiac damage were compared according to sex, and its implications on clinical outcomes after TAVR were explored. RESULTS: Among 2,026 patients undergoing TAVR between August 2007 and June 2022 (995 [49.1%] women and 1,031 [50.9%] men), we observed sex-specific differences in the pattern of cardiac damage (women vs men; stage 0: 2.6% vs 3.1%, stage 1: 13.4% vs 10.1%, stage 2: 37.1% vs 39.5%, stage 3: 27.5% vs 15.6%, and stage 4: 19.4% vs 31.7%). There was a stepwise increase in 5-year all-cause mortality according to stage in women (HRadjusted: 1.43; 95% CI: 1.28-1.60, for linear trend) and men (HRadjusted: 1.26; 95% CI: 1.14-1.38, for linear trend). Female sex was associated with a lower 5-year mortality in early stages (stage 0, 1, or 2) but not in advanced stages (stage 3 or 4). CONCLUSIONS: The pattern of cardiac damage secondary to AS differed by sex. In early stages of cardiac damage, women had a lower 5-year mortality than men, whereas in more advanced stages, mortality was comparable between sexes. (SwissTAVI Registry; NCT01368250).

Assessment of transabdominal fat volumes as a predictor of prognosis in patients undergoing transcatheter aortic valve replacement.

Transcatheter aortic valve replacement (TAVR) has emerged as a well-established treatment option for eligible patients with severe aortic stenosis. This study aimed to investigate the correlation between abdominal fat tissue volumes, measured using computed tomography (CT), and all-cause mortality in patients undergoing TAVR. The study included 258 consecutive patients who underwent TAVR at a single center between September 2017 and November 2020. During the preoperative preparation, CT scans were used to perform a semi-quantitative measurement of abdominal fat components. Body mass index (BMI) for each participant was calculated. The relationship between fat parameters and overall survival was determined using multivariable Cox proportional hazards models. Participants had a mean age of 76.8 ± 7.8 years, of whom 32.9% were male. The median follow-up period was 12 months, during which 38 patients (14.7%) died. Both the survivor and non-survivor groups showed comparable risk factors. Regarding transabdominal fat volume parameters, deceased individuals exhibited significantly lower values. However, no significant differences were observed in BMI and transabdominal area measurements. Among transabdominal fat parameters, only subcutaneous fat volume [adjusted Hazard Ratio (aHR) = 0.83, p = 0.045] and total fat volume (TFV) [aHR = 0.82, p = 0.007] were identified as significant predictors of reduced all-cause mortality. Furthermore, TFV demonstrated the highest discriminative performance with a threshold of ≤ 9.1 L (AUC = 0.751, p < 0.001, sensitivity 71.1%, specificity 70.9%). Preoperative CT-based abdominal fat volume parameters, particularly TFV, can serve as potential predictors of survival in patients undergoing TAVR.

Assessing medical devices: a qualitative study from the validate perspective.

OBJECTIVES: Our objective was to explore procedures and methods used at health technology assessment (HTA) agencies for assessing medical devices and the underlying views of HTA practitioners about appropriate methodology to identify challenges in adopting new methodologies for assessing devices. We focused on the role of normative commitments of HTA practitioners in the adoption of new methods. METHODS: An online survey, including questions on procedures, scoping, and assessments of medical devices, was sent to members of the International Network of Agencies for Health Technology Assessment. Interviews were conducted with survey respondents and HTA practitioners involved in assessments of transcatheter aortic valve implantation to gain an in-depth understanding of choices made and views about assessing medical devices. Survey and interview questions were inspired by the "values in doing assessments of health technologies" approach towards HTA, which states that HTA addresses value-laden questions and information. RESULTS: The current practice of assessing medical devices at HTA agencies is predominantly based on procedures, methods, and epistemological principles developed for assessments of drugs. Both practical factors (available time, demands of decision-makers, existing legal frameworks, and HTA guidelines), as well as commitments of HTA practitioners to principles of evidence-based medicine, make the adoption of a new methodology difficult. CONCLUSIONS: There is a broad recognition that assessments of medical devices may need changes in HTA methodology. In order to realize this, the HTA community may require both a discussion on the role, responsibility, and goals of HTA, and resulting changes in institutional context to adopt new methodologies.

Cost-effectiveness analysis of transcatheter aortic valve implantation in aortic stenosis patients at low- and intermediate-surgical risk in Japan.

OBJECTIVE: To analyze the cost-effectiveness of transcatheter aortic valve implantation (TAVI) using the SAPIEN 3 (Edwards Lifesciences, Irvine, CA) compared to surgical aortic valve replacement (SAVR) in low- and intermediate-risk patients from a Japanese public healthcare payer perspective. METHODS: A Markov model cost-effectiveness analysis was developed. Clinical and utility data were extracted from a systematic literature review. Cost inputs were obtained from analysis of the Medical Data Vision claims database and supplemented with a targeted literature search. The robustness of the results was assessed using sensitivity analyses. Scenario analyses were performed to determine the impact of lower mean age (77.5 years) and the effect of two different long-term mortality hazard ratios (TAVI versus SAVR: 0.9-1.09) on both risk-level populations. This analysis was conducted according to the guidelines for cost-effectiveness evaluation in Japan from Core 2 Health. RESULTS: In intermediate-risk patients, TAVI was a dominant procedure (TAVI had lower cost and higher effectiveness). In low-risk patients, the incremental cost effectiveness ratio (ICER) for TAVI was ¥750,417/quality-adjusted-life-years (QALY), which was below the cost-effectiveness threshold of ¥5 million/QALY. The ICER for TAVI was robust to all tested sensitivity and scenario analyses. CONCLUSIONS: TAVI was dominant and cost-effective compared to SAVR in intermediate- and low-risk patients, respectively. These results suggest that TAVI can provide meaningful value to Japanese patients relative to SAVR, at a reasonable incremental cost for patients at low surgical risk and potentially resulting in cost-savings in patients at intermediate surgical risk.

Aortic Stenosis (AS) is the most common valvular heart disease in Japan, and, if left untreated, severe symptomatic AS (sSAS) is associated with a dramatic increase in mortality and morbidity. Transcatheter Aortic Valve Implantation (TAVI) is a minimally invasive treatment option for replacing the aortic valve in patients with sSAS and has been associated with similar or better outcomes compared to Surgical Aortic Valve Replacement (SAVR), which involves open-heart surgical replacement of the aortic valve. The objective of this study was to compare the costs and health outcomes associated with TAVI compared to SAVR in Japanese patients deemed low- or intermediate-risk for surgery. Despite the expanding use of TAVI in Japan, a cost-effectiveness analysis (CEA) does not exist that evaluates the economics of TAVI with the current generation SAPIEN 3 implant in patients with low- and intermediate-risk from a public perspective. Our study suggests that TAVI represents strong value for money among low- and intermediate-risk patients in Japan: compared to SAVR, TAVI is associated with better clinical outcomes and quality of life for patients, at a reasonable additional cost for low-risk patients and at a lower cost for intermediate-risk patients.

Deep Learning Image Reconstruction for Transcatheter Aortic Valve Implantation Planning: Image Quality, Diagnostic Performance, Contrast volume and Radiation Dose Assessment.

RATIONALE AND OBJECTIVES: To assess image quality, contrast volume and radiation dose reduction potential and diagnostic performance with the use of high-strength deep learning image reconstruction (DLIR-H) in transcatheter aortic valve implantation (TAVI) planning CT. METHODS: We prospectively enrolled 128 patients referred to TAVI-planning CT. Patients were randomly divided into two groups: DLIR-H group (n = 64) and conventional group (n = 64). The DLIR-H group was scanned with tube voltage of 80kVp and body weighted-dependent contrast injection rate of 28mgI/kg/s, images reconstructed using DLIR-H; the conventional group was scanned with 100kVp and contrast injection rate of 40mgI/kg/s, and images reconstructed using adaptive statistical iterative reconstruction-V at 50% (ASIR-V 50%). Radiation dose, contrast volume, contrast injection rate, and image quality were compared between the two groups. The diagnostic performance of TAVI planning CT for coronary stenosis in 115 patients were calculated using invasive coronary angiography as golden standard. RESULTS: DLIR-H group significantly reduced radiation dose (4.94 ± 0.39mSv vs. 7.93 ± 1.20mSv, p < 0.001), contrast dose (45.28 ± 5.38 mL vs. 63.26 ± 9.88 mL, p < 0.001), and contrast injection rate (3.1 ± 0.31 mL/s vs. 4.9 ± 0.2 mL/s, p < 0.001) compared to the conventional group. Images in DLIR-H group had significantly higher SNR and CNR (all p < 0.001). For the diagnostic performance on a per-patient basis, TAVI planning CT in the DLIR-H group provided 100% sensitivity, 92.1% specificity, 100% negative predictive value (NPV), and 84.2% positive predictive value for the detection of > 50% stenosis. In the conventional group, the corresponding results were 94.7%, 95.3%, 97.6%, and 90.0%, respectively. CONCLUSION: DLIR-H in TAVI-planning CT provides improved image quality with reduced radiation and contrast doses, and enables satisfactory diagnostic performance for coronary arteries stenosis.

Coronary Artery Disease Assessment via On-Site CT Fractional Flow Reserve in Patients Undergoing Transcatheter Aortic Valve Replacement.

Purpose To examine the clinical feasibility of workstation-based CT fractional flow reserve (CT-FFR) for coronary artery disease (CAD) evaluation during preprocedural planning in patients undergoing transcatheter aortic valve replacement (TAVR). Materials and Methods In this retrospective single-center study, 434 patients scheduled for TAVR between 2018 and 2020 were screened for study inclusion; a relevant proportion of patients (35.0% [152 of 434]) was not suitable for evaluation due to insufficient imaging properties. A total of 112 patients (mean age, 82.1 years ± 6.7 [SD]; 58 [52%] men) were included in the study. Invasive angiography findings, coronary CT angiography results, and Agatston score were acquired and compared with on-site CT-FFR computation for evaluation of CAD and prediction of major adverse cardiovascular events (MACE) within a 24-month follow-up. Results Hemodynamic relevant CAD, as suggested by CT-FFR of 0.80 or less, was found in 41 of 70 (59%) patients with stenosis of 50% or more. MACE occurred in 23 of 112 (20.5%) patients, from which 14 of 23 had stenoses with CT-FFR of 0.80 or less (hazard ratio [HR], 3.33; 95% CI: 1.56, 7.10; P = .002). CT-FFR remained a significant predictor of MACE after inclusion in a multivariable model with relevant covariables (HR, 2.89; 95% CI: 1.22, 6.86; P = .02). An Agatston score of 1000 Agatston units or more (HR, 2.25; 95% CI: 0.98, 5.21; P = .06) and stenoses of 50% or more determined via invasive angiography (HR, 0.94; 95% CI: 0.41, 2.17; P = .88) were not significant predictors of MACE. Conclusion Compared with conventional CAD markers, CT-FFR better predicted adverse outcomes after TAVR. A relevant portion of the screened cohort, however, was not suitable for CT-based CAD evaluation. Keywords: CT, Transcatheter Aortic Valve Implantation/Replacement (TAVI/TAVR), Cardiac, Coronary Arteries, Outcomes Analysis © RSNA, 2024 See also the commentary by Weir-McCall and Pugliese in this issue.

Transcatheter aortic valve implantation versus surgical aortic valve replacement in severe aortic stenosis patients at low surgical mortality risk: a cost-effectiveness analysis in Belgium.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) with the SAPIEN 3 device has recently shown significant clinical benefits, compared to surgical aortic valve replacement (SAVR), in patients at low risk for surgical mortality (PARTNER 3 trial, NCT02675114). Currently in Belgium, TAVI use is restricted to high-risk or inoperable patients with severe symptomatic aortic stenosis (sSAS). This cost-utility analysis aimed to assess whether TAVI with SAPIEN 3 could lead to potential cost-savings compared with SAVR, in the low-risk sSAS population in Belgium. METHODS: A previously published, two-stage, Markov-based cost-utility model was used. Clinical outcomes were captured using data from PARTNER 3 and the model was adapted for the Belgian context using cost data from the perspective of the Belgian National Healthcare System, indexed to 2022. A lifetime horizon was chosen. The model outputs included changes in direct healthcare costs, survival and health-related quality of life using TAVI versus SAVR. RESULTS: TAVI with SAPIEN 3 provides meaningful clinical and cost benefits over SAVR, in terms of an increase in quality-adjusted life years (QALYs) of 0.94 and cost-saving of €3 013 per patient. While initial procedure costs were higher for TAVI compared with SAVR, costs related to rehabilitation, disabling stroke, treated atrial fibrillation, and rehospitalization were lower. The cost-effectiveness of TAVI over SAVR remained robust in sensitivity analyses. CONCLUSION: TAVI with SAPIEN 3 may offer a meaningful alternative intervention to SAVR in Belgian low-risk patients with sSAS, showing both clinical benefits and cost savings associated with post-procedure patient management.

Does Comprehensive Geriatric Assessment Reduce the Incidence of Postoperative Delirium? A Quasi-experimental Study in Older Adults Undergoing Transcatheter Aortic Valve Implantation.

Purpose: Postoperative delirium (POD) after transcatheter aortic valve implantation (TAVI) is frequent in older adults and associated with multiple negative outcomes including a higher mortality. We aimed to investigate whether a comprehensive geriatric assessment (CGA) prior to TAVI reduces the odds of POD and results in a positive change in self-care ability, intended to lay a foundation for future geriatric comanagement. Patients and methods: We used a retrospective, single-center study with a quasi-experimental design enrolling patients aged 70 years and older undergoing CGA before elective TAVI, and a nonrandomized comparison group without preoperative CGA. Data on POD occurrence during the first 5 days after TAVI (primary outcome) and change in self-care ability index (SPI) between admission and discharge (secondary outcome) were collected from electronic health records and CGA data (exposure) by clinical assessment. To explore associations between (1) CGA and POD, and (2) CGA and SPI, multivariate logistic regression and linear regression models were applied adjusting for age, sex, BMI, and number of medications. Results: Among 435 patients (mean age 81.0 ± 5.6 years, 43.6% women, median [IQR] SPI at baseline 40 [39, 40] points), POD incidence was 14.3% in the CGA group vs 18.8% in the non-CGA group (P 0.219). Undergoing CGA before TAVI was not associated with the odds for POD (OR: 1.15; 95%CI: 0.65-2.04) or improved SPI (P 0.073). Conclusion: We observed no association of CGA prior to TAVI with POD incidence or postoperative self-care, highlighting the need for additional studies investigating the effect of POD preventive measures in older TAVI patients integrated into a comprehensive geriatric comanagement program.

Assessment of paravalvular regurgitation after transcatheter aortic valve replacement using 2D multi-velocity encoding and 4D flow cardiac magnetic resonance.

AIMS: To compare the novel 2D multi-velocity encoding (venc) and 4D flow acquisitions with the standard 2D flow acquisition for the assessment of paravalvular regurgitation (PVR) after transcatheter aortic valve replacement (TAVR) using cardiac magnetic resonance (CMR)-derived regurgitant fraction (RF). METHODS AND RESULTS: In this prospective study, patients underwent CMR 1 month after TAVR for the assessment of PVR, for which 2D multi-venc and 4D flow were used, in addition to standard 2D flow. Scatterplots and Bland-Altman plots were used to assess correlation and visualize agreement between techniques. Reproducibility of measurements was assessed with intraclass correlation coefficients. The study included 21 patients (mean age ± SD 80 ± 5 years, 9 men). The mean RF was 11.7 ± 10.0% when standard 2D flow was used, 10.6 ± 7.0% when 2D multi-venc flow was used, and 9.6 ± 7.3% when 4D flow was used. There was a very strong correlation between the RFs assessed with 2D multi-venc and standard 2D flow (r = 0.88, P < 0.001), and a strong correlation between the RFs assessed with 4D flow and standard 2D flow (r = 0.74, P < 0.001). Bland-Altman plots revealed no substantial bias between the RFs (2D multi-venc: 1.3%; 4D flow: 0.3%). Intra-observer and inter-observer reproducibility for 2D multi-venc flow were 0.98 and 0.97, respectively, and 0.92 and 0.90 for 4D flow, respectively. CONCLUSION: Two-dimensional multi-venc and 4D flow produce an accurate quantification of PVR after TAVR. The fast acquisition of the 2D multi-venc sequence and the free-breathing acquisition with retrospective plane selection of the 4D flow sequence provide useful advantages in clinical practice, especially in the frail TAVR population.

Aortic valve replacement today: Outcomes, costs, and opportunities for improvement.

The introduction of transcatheter aortic valve replacement (TAVR) just two decades ago has transformed the treatment of severe symptomatic aortic stenosis. TAVR has not only extended the option of aortic valve replacement to patients deemed ineligible for surgery, it has also demonstrated similar or better short- and intermediate-term clinical outcomes compared with surgical aortic valve replacement (SAVR) in patients at all levels of surgical risk. These benefits have been achieved with similar or lower costs compared with SAVR, at least in the first 1-2 years for intermediate- and low-risk patients. Longer-term data will further inform clinical and shared decision-making. SUMMARY FOR ANNOTATED TABLE OF CONTENTS: In just over two decades, transcatheter aortic valve replacement has emerged as a frontline approach for appropriately selected patients with severe aortic stenosis. A growing body of evidence documents similar or better clinical outcomes and cost-effectiveness for transcatheter compared with surgical aortic valve replacement. Whether the mode is transcatheter or surgical, aortic valve replacement remains underutilized in patients with clear indications for intervention.

Photon-counting CT-angiography in pre-TAVR aortic annulus assessment: effects of retrospective vs. prospective ECG-synchronization on prosthesis valve selection.

To compare the diagnostic value of ultrahigh-resolution CT-angiography (UHR-CTA) compared with high-pitch spiral CTA (HPS-CTA) using a first-generation, dual-source photon-counting CT (PCD-CT) scanner for preprocedural planning of transcatheter aortic valve replacement (TAVR). Clinically referred patients with severe aortic valve stenosis underwent both, retrospective ECG-gated cardiac UHR-CTA (collimation: 120 × 0.2 mm) and prospective ECG-triggered aortoiliac HPS-CTA (collimation: 144 × 0.4 mm, full spectral capabilities) for TAVR planning from August 2022 to March 2023. Radiation dose was extracted from the CT reports, and the effective dose was calculated. Two radiologists analyzed UHR-CTA and HPS-CTA datasets, assessing the image quality of the aortic annulus, with regard to the lumen visibility and margin delineation using a 4-point visual-grading scale (ranges: 4 = "excellent" to 1 = "poor"). Aortic annulus area (AAA) measurements were taken for valve prosthesis sizing, with retrospective UHR-CTA serving as reference standard. A total of 64 patients were included (mean age, 81 years ± 7 SD; 28 women) in this retrospective study. HPS-CTA showed a lower radiation dose, 4.1 mSv vs. 12.6 mSv (p < 0.001). UHR-CTA demonstrated higher image quality to HPS-CTA (median score, 4 [IQR, 3-4] vs. 3 [IQR, 2-3]; p < 0.001). Quantitative assessments of AAA from both CTA datasets were strongly positively correlated (mean 477.4 ± 91.1 mm2 on UHR-CTA and mean 476.5 ± 90.4 mm2 on HPS-CTA, Pearson r2 = 0.857, p < 0.001) with a mean error of 22.3 ± 24.6 mm2 and resulted in identical valve prosthesis sizing in the majority of patients (91%). Patients with lower image quality on HPS-CTA (score value 1 or 2, n = 28) were more likely to receive different sizing recommendations (82%). Both UHR-CTA and HPS-CTA acquisitions using photon-counting CT technology provided reliable aortic annular assessments for TAVR planning. While UHR-CTA offers superior image quality, HPS-CTA is associated with lower radiation exposure. However, severely impaired image quality on HPS-CTA may impact on prosthesis sizing, suggesting that immediate post-scan image evaluations may require complementary UHR-CTA scanning.

Geographic variation in aortic stenosis treatment and outcomes among Medicare beneficiaries in the United States.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) has changed the landscape of aortic stenosis (AS) management. AIM: To describe and evaluate geographic variation in AS treatment and outcomes among a sample of Medicare beneficiaries. METHODS: A retrospective analysis of administrative claims data was conducted on a 20% sample of Medicare fee-for-service beneficiaries aged 65 and older with a diagnosis of AS (2015-2018). Estimates of demographic, comorbidity, and healthcare resources were obtained from Medicare claims and the Dartmouth Atlas of Health Care at the hospital referral region (HRR), which represents regional tertiary medical care markets. Linear regression was used to explain HRR-level variation in rates of surgical aortic valve replacement (SAVR) and TAVR, and 1-year mortality and readmission rates. RESULTS: A total of 740,899 beneficiaries with AS were identified with a median prevalence of AS of 39.9 per 1000 Medicare beneficiary years. The average HRR-level rate of SAVR was 26.3 procedures per 1000 beneficiary years and the rate of TAVR was 20.3 procedures per 1000 beneficiary years. HRR-level comorbidities and number of TAVR centers were associated with a lower SAVR rate. Demographics and comorbidities explained most of the variation in HRR-level 1-year mortality (15.2% and 18.8%) and hospitalization rates (20.5% and 16.9%), but over half of the variation remained unexplained. CONCLUSION: Wide regional variation in the treatment and outcomes of AS was observed but were largely unexplained by patient factors and healthcare utilization. Understanding the determinants of AS treatment and outcomes can inform population health efforts for these patients.

Personalised preinterventional risk stratification of mortality, length of stay and hospitalisation costs in transcatheter aortic valve implantation using a machine learning algorithm: a pilot trial.

INTRODUCTION: Risk stratification based on Euroscore II (ESII) is used in some centres to assist decisions to perform transcatheter aortic valve implant (TAVI) procedures. ESII is a generic, non-TAVI-specific metric, and its performance fades for mortality at follow-up longer than 30 days. We investigated if a TAVI-specific predictive model could achieve improved predictive preinterventional accuracy of 1-year mortality compared with ESII. PATIENTS AND METHODS: In this prospective pilot study, 284 participants with severe symptomatic aortic valve stenosis who underwent TAVI were enrolled. Standard clinical metrics (American Society of Anesthesiology (ASA), New York Heart Association and ESII) and patient-reported outcome measures (EuroQol-5 Dimension-Visual Analogue Scale, Kansas City Cardiomyopathy Questionnaire and Clinical Frailty Scale (CFS)) were assessed 1 day before TAVI. Using these data, we tested predictive models (logistic regression and decision tree algorithm (DTA)) with 1-year mortality as the dependent variable. RESULTS: Logistic regression yielded the best prediction, with ASA and CFS as the strongest predictors of 1-year mortality. Our logistic regression model score showed significantly better prediction accuracy than ESII (area under the curve=0.659 vs 0.800; p=0.002). By translating our results to a DTA, cut-off score values regarding 1-year mortality risk emerged for low, intermediate and high risk. Treatment costs and length of stay (LoS) significantly increased in high-risk patients. CONCLUSIONS AND SIGNIFICANCE: A novel TAVI-specific model predicts 1-year mortality, LoS and costs after TAVI using simple, established, transparent and inexpensive metrics before implantation. Based on this preliminary evidence, TAVI team members and patients can make informed decisions based on a few key metrics. Validation of this score in larger patient cohorts is needed.

Histological assessment of cardiac amyloidosis in patients undergoing transcatheter aortic valve replacement.

AIMS: Studies have reported a strongly varying co-prevalence of aortic stenosis (AS) and cardiac amyloidosis (CA). We sought to histologically determine the co-prevalence of AS and CA in patients undergoing transcatheter aortic valve replacement (TAVR). Consequently, we aimed to derive an algorithm to identify cases in which to suspect the co-prevalence of AS and CA. METHODS AND RESULTS: In this prospective, monocentric study, endomyocardial biopsies of 162 patients undergoing TAVR between January 2017 and March 2021 at the University Medical Centre Göttingen were analysed by one pathologist blinded to clinical data using haematoxylin-eosin staining, Elastica van Gieson staining, and Congo red staining of endomyocardial biopsies. CA was identified in only eight patients (4.9%). CA patients had significantly higher N-terminal pro-brain natriuretic peptide (NT-proBNP) levels (4356.20 vs. 1938.00 ng/L, P = 0.034), a lower voltage-to-mass ratio (0.73 vs. 1.46 × 10-2 mVm2/g, P = 0.022), and lower transaortic gradients (Pmean 17.5 vs. 38.0 mmHg, P = 0.004) than AS patients. Concomitant CA was associated with a higher prevalence of post-procedural acute kidney injury (50.0% vs. 13.1%, P = 0.018) and sudden cardiac death [SCD; P (log-rank test) = 0.017]. Following propensity score matching, 184 proteins were analysed to identify serum biomarkers of concomitant CA. CA patients expressed lower levels of chymotrypsin (P = 0.018) and carboxypeptidase 1 (P = 0.027). We propose an algorithm using commonly documented parameters-stroke volume index, ejection fraction, NT-proBNP levels, posterior wall thickness, and QRS voltage-to-mass ratio-to screen for CA in AS patients, reaching a sensitivity of 66.6% with a specificity of 98.1%. CONCLUSIONS: The co-prevalence of AS and CA was lower than expected, at 4.9%. Despite excellent 1 year mortality, AS + CA patients died significantly more often from SCD. We propose a multimodal algorithm to facilitate more effective screening for CA containing parameters commonly documented during clinical routine. Proteomic biomarkers may yield additional information in the future.