Risk assessment in patients with left ventricular systolic dysfunction following transcatheter aortic valve replacement.

BACKGROUND: Mortality following transcatheter aortic valve replacement (TAVR) in patients with post-procedural left ventricular systolic dysfunction remains high. We investigated clinical variables associating with worse clinical outcomes following TAVR in patients with systolic dysfunction. METHODS: We retrospectively investigated 2588 patients with severe aortic stenosis who received TAVR and were enrolled in the optimized transcatheter valvular intervention (OCEAN-TAVI) multicenter registry (UMIN000020423). The association between the clinical variables following TAVR and 2-year cardiovascular mortality was investigated among those with post-TAVR left ventricular ejection fraction less than 50%. RESULTS: A total of 298 patients (median 85 years old, 131 men) were included. The presence of moderate or greater tricuspid regurgitation following TAVR was independently associated with 2-year mortality (adjusted hazard ratio 3.41, 95% confidence interval 1.15-10.1), and significantly discriminated 2-year cardiovascular mortality (30% vs. 12%, p = 0.001). No patients with any improvement in tricuspid regurgitation had cardiovascular death. CONCLUSION: Following TAVR, the existence of significant tricuspid regurgitation was associated with cardiovascular mortality in patients with heart failure with reduced ejection fraction.

Importance of combined assessment of skeletal muscle mass and density by computed tomography in predicting clinical outcomes after transcatheter aortic valve replacement.

Skeletal muscle mass (SMM) as calculated by computed tomography (CT) is a predictor of all-cause mortality after transcatheter aortic valve replacement (TAVR), but it remains unclear whether using CT-determined density of skeletal muscle has additive prognostic value. We utilized the Japanese multicenter registry data of 1375 patients who underwent CT prior to TAVR. Sarcopenia status was defined by the CT-derived SMM index (threshold: men, 55.4 cm2/m2; women, 38.9 cm2/m2). The threshold for high and low CT density was based on the median value of the entire cohort (men: 33.4 HU; women: 29.5 HU). Sarcopenia was observed in 802 patients (58.3%) overall. Patients were categorized into non-sarcopenia and high-CT density (n = 298), non-sarcopenia and low-CT density (n = 275), sarcopenia and high-CT density (n = 399), and sarcopenia and low-CT density (n = 403) groups, and procedural outcomes and mortality compared. The cumulative 3-year mortality rates in these groups were 18%, 27%, 24%, and 32%, respectively. Cox-regression multivariate analysis revealed that low-CT density (compared with high-CT density) and sarcopenia and low-CT density (compared with non-sarcopenia and high-CT density as reference) increased mortality after TAVR (hazard ratios [HR]: 1.35 and 1.43, 95% confidence intervals [Cis]: 1.06-1.72 and 1.00-2.08, p = 0.01, and 0.049, respectively). However, sarcopenia alone was not related to an increased risk of mortality (HR 1.30, 95% CI 0.99-1.69, p = 0.52). In conclusion, CT density-based skeletal muscle quality assessment combined with the SMM index improves prediction of adverse outcomes after TAVR.

Cost-Effectiveness of Transcatheter Aortic Valve Implantation Using a Balloon-Expandable Valve in Japan: Experience From the Japanese Pilot Health Technology Assessment.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is an innovative and effective treatment in high-surgical-risk (HR) and inoperable patients with symptomatic severe aortic stenosis. OBJECTIVES: This cost-effectiveness analysis of transfemoral TAVI (TF-TAVI) compared with surgical aortic valve replacement (SAVR) conforms with the methodological guidelines for cost-effectiveness evaluation by the Ministry of Health, Labor, and Welfare in Japan. METHODS: The cost-effectiveness of TF-TAVI using SAPIEN XT was evaluated using a lifetime Markov simulation from the national payer perspective. Comparators were SAVR for HR patients and standard of care (SOC) for inoperable patients. A systematic literature review for clinical evidence of TF-TAVI and comparators was conducted. The evidence for TF-TAVI was derived from the SOURCE XT registry and Japanese post marketing surveillance. Because there was no literature directly or indirectly comparing TF-TAVI using SAPIEN XT with comparators, the comparator data were selected from relevant published studies, considering the similarity of study eligibility criteria and patient backgrounds (eg, age and surgical risk scores). Sensitivity analyses were used to validate the robustness of results. RESULTS: The incremental cost-effectiveness ratio of TF-TAVI versus SAVR for HR patients was ¥1.3 million/quality-adjusted life-years (QALYs). The incremental cost-effectiveness ratio of TF-TAVI versus SOC for inoperable patients was ¥3.5 million/QALY. CONCLUSIONS: TF-TAVI was cost-effective when compared with SAVR for HR patients and when compared with SOC for inoperable patients, using a threshold of ¥5 million/QALY.

Previously implanted mitral surgical prosthesis in patients undergoing transcatheter aortic valve implantation: Procedural outcome and morphologic assessment using multidetector computed tomography.

Transcatheter aortic valve implantation (TAVI) in the presence of a preexisting mitral prosthesis is challenging and its influence on the morphology of mitral prosthesis and the positioning of transcatheter heart valve (THV) is unknown. We assessed the feasibility of TAVI for patients with preexisting mitral prostheses, its influence on mitral prosthesis morphology, and the positional interaction between a newly implanted THV and mitral prosthesis using serial multidetector computed tomography (MDCT). Thirty-one patients with preexisting mitral prosthesis undergoing TAVI were included. MDCT was performed before and after TAVI. Thirty patients successfully underwent TAVI without interference from preexisting mitral prosthesis. Although opening disturbance of the mechanical mitral prosthesis by the THV edge was observed in 1 patient, the patient was managed conservatively. No THV embolization occurred. THV shift during deployment occurred in 9 patients and was predicted by a larger aortic annulus area (odds ratio: 1.24 per 10 mm2, 1.03-1.49, p = 0.02), possibly because of large THVs. The mitral mean pressure gradient was slightly higher after TAVI (3.7 vs. 4.3 mmHg, p = 0.002), whereas the mitral regurgitation grade was similar. MDCT showed that the size of the mitral prosthesis housing was unchanged after TAVI. The median distance between the mitral prosthesis and THV was 2.6 mm. The postprocedural angle between the mitral prosthesis and THV was larger than the preprocedural angle between the mitral prosthesis and the left ventricular outflow tract (64° vs. 61°, p = 0.03). Thus, TAVI is feasible in the case of preexisting mitral prosthesis. Serial MDCT demonstrated favorable THV positioning and unchanged mitral prosthesis morphology after TAVI.

Importance of Geriatric Nutritional Risk Index assessment in patients undergoing transcatheter aortic valve replacement.

BACKGROUND: Nutritional condition is one marker of patients' frailty. The Geriatric Nutritional Risk Index (GNRI) is a well-known marker of nutritional status. This study sought to assess the clinical outcomes of GNRI after transcatheter aortic valve replacement (TAVR). METHODS: We evaluated the GNRI value of 1,613 patients who underwent TAVR using data from a Japanese multicenter registry. According to baseline GNRI, patients were classified into 3 groups: GNRI ≥92 (n = 1,085; 67.3%), GNRI 82-92 (n = 396; 24.6%), and GNRI ≤82 (n = 132; 8.2%). Baseline characteristics, procedural outcomes, and cumulative mortality rates were compared. In addition, GNRI correlations with other frailty components (gait speed, grip strength, and Clinical Frailty Scale) and Society of Thoracic Surgeons (STS) score were also evaluated. RESULTS: Significantly increased mortality rates were observed across the 3 groups at 30 days (0.9%, 2.3%, and 6.8%, respectively; P < .001) and 1 year (6.5%, 16.4%, and 36.4%, respectively; P < .001). Both GNRI 82-92 and GNRI ≤82 (as a reference for GNRI ≥92) were independently associated with increased midterm mortality in the Cox regression multivariate model (hazard ratio: 1.97, 3.60; 95% confidence interval: 1.37-2.84, 2.30-5.64; P < .001, P < .001, respectively). The GNRI value was significantly correlated with gait speed (Spearman ρ = -0.15, P < .001), grip strength (ρ = 0.25, P < .001), Clinical Frailty Scale (ρ = -0.24, P < .001), and STS score (ρ = -0.29, P < .001). CONCLUSIONS: GNRI is related to both frailty components and the STS score and is an important surrogate marker for predicting worse clinical outcomes after TAVR. Assessment of the GNRI may be considered when deciding on TAVR.

Predictors of high cost after percutaneous coronary intervention: A review from Japanese multicenter registry overviewing the influence of procedural complications.

BACKGROUND: Percutaneous coronary intervention (PCI) is widely used; however, factors of high-cost care after PCI have not been thoroughly investigated. We sought to evaluate the in-hospital costs related to PCI and identify predictors of high costs. METHODS: We extracted 2,354 consecutive PCI cases (1,243 acute cases, 52.8%) from 3 Japanese cardiovascular centers from 2011 to 2015. In-hospital complications were predefined under consensus definitions (eg, acute kidney injury [AKI]). We extracted the facility cost data for each patient's resource under the universal Japanese insurance system. We classified the patients into total cost quartiles and identified predictors for the highest quartile ("high-cost" group). In addition, incremental costs for procedure-related complications were calculated. RESULTS: During the study period, a total of 401 cases (17.0%) experienced procedure-related complications. The in-hospital acute and elective PCI costs per case were US $14,840 (interquartile range [IQR] 11,370-20,070) and US $11,030 (IQR 8929-14,670), respectively. After adjusting for baseline differences, any of the procedure-related complications remained an independent predictor of high costs (acute: odds ratio 1.66, 95% CIs 1.13-2.43; elective: odds ratio 3.73, 95% CIs 1.96-7.11). Notably, incremental costs were mainly attributed to AKI, which accounted for 37.5% of all incremental costs; it increased by US $9,840 for each AKI event, and the total cost increase reached US $2,588,035. CONCLUSIONS: Procedure-related complications, particularly postprocedural AKI, were associated with higher costs in PCI. Further studies are required to evaluate prospectively whether the preventive strategy with a personalized risk stratification for AKI could save costs.

Significance of echocardiographic assessment for right ventricular function after balloon pulmonary angioplasty in patients with chronic thromboembolic induced pulmonary hypertension.

Balloon pulmonary angioplasty (BPA) may improve hemodynamics and exercise tolerance in patients with chronic thromboembolic pulmonary hypertension (CTEPH). We studied consecutive 25 patients with CTEPH who underwent BPA and evaluated hemodynamics by right-sided heart catheterization. Right ventricular (RV) function was assessed before and after BPA by echocardiography including speckle-tracking echocardiography and 3-dimensional echocardiography. BPA improved the mean pulmonary artery pressure, pulmonary vascular resistance, and cardiac index. BPA also ameliorated the 3-dimentional RV volume, RV ejection fraction, and RV systolic peak strain, all of which were significantly correlated with hemodynamic parameters. The changes in cardiac index were significantly correlated with those in 3-dimentional RV volume index. Furthermore, RV dyssynchrony quantified by the RV strain analyses was ameliorated after BPA even in patients with mild pulmonary hypertension, implicating the merit of BPA in this patient population with CTEPH. BPA not only improved the hemodynamics in patients with CTEPH, but also ameliorated RV remodeling and dyssynchrony as assessed by 3-dimensional echocardiography or speckle-tracking echocardiography. Thus, the assessment of RV function may provide valuable information about the appropriate indication for BPA, its efficacy, and the therapeutic goal for patients with CTEPH.

Appropriateness ratings of percutaneous coronary intervention in Japan and its association with the trend of noninvasive testing.

OBJECTIVES: The aim of this study was to evaluate the appropriateness of percutaneous coronary intervention (PCI) in Japan and clarify the association between trends of pre-procedural noninvasive testing and changes in appropriateness ratings. BACKGROUND: Although PCI appropriateness criteria are widely used for quality-of-care improvement, they have not been validated internationally. Furthermore, the correlation of appropriateness ratings with implementation of newly developed noninvasive testing is unclear. METHODS: We assigned an appropriateness rating to 11,258 consecutive PCIs registered in the Japanese Cardiovascular Database according to appropriateness use criteria developed in 2009 (AUC/2009) and the 2012 revised version (AUC/2012). Trends of pre-procedural noninvasive testing and appropriateness ratings were plotted; logistic regression was performed to identify inappropriate PCI predictors. RESULTS: In nonacute settings, 15% of PCIs were rated inappropriate under AUC/2009, and this percent increased to 30.7% under AUC/2012 criteria. This was mostly because of the focused update of AUC, in which the patients were newly classified as inappropriate if they lacked proximal left anterior descending lesions and did not undergo pre-procedural noninvasive testing. However, these cases were simply not rated under AUC/2009. The amount of inappropriate PCIs increased over 5 years, proportional to the increase in coronary computed tomography angiography use. Use of coronary computed tomography angiography was independently associated with inappropriate PCIs (odds ratio: 1.33; p = 0.027). CONCLUSIONS: In a multicenter, Japanese PCI registry, approximately one-sixth of nonacute PCIs were rated as inappropriate under AUC/2009, increasing to approximately one-third under the revised AUC/2012. This significant gap may reflect a needed shift in appropriateness recognition of methods for noninvasive pre-procedural evaluation of coronary artery disease.

Automated 3-dimensional aortic annular assessment by multidetector computed tomography in transcatheter aortic valve implantation.

OBJECTIVES: This study sought to evaluate the accuracy, reproducibility, and predictive value for post-procedural aortic regurgitation (AR) of an automated multidetector computed tomography (MDCT) post-processing imaging software, 3mensio Valves (version 5.1.sp1, 3mensio Medical Imaging BV, the Netherlands), in the assessment of patients undergoing transcatheter aortic valve implantation (TAVI). BACKGROUND: Accurate pre-operative aortic annulus measurements are crucial for patients undergoing TAVI. METHODS: One hundred five patients undergoing MDCT screening before TAVI were evaluated. Aortic annular measurement was compared between automated 3mensio Valves software and manual data post-processing software on a dedicated workstation; we analyzed the discrimination value of annulus measurement for post-procedural AR in 44 recipients of a self-expanding valve. RESULTS: The automated 3mensio Valves software showed good concordance with manual MDCT measurements as demonstrated by Bland-Altman analysis. The automated software provided equally good reproducibility as manual measurement, especially for measurement of aortic annulus area (intraobserver intraclass correlation coefficients 0.98 vs. 0.97, interobserver 0.98 vs. 0.95). In 44 patients after implantation of a self-expanding valve, the valve diameter/CT-measured geometric mean annulus diameter ratio by automated 3mensio Valves software showed moderate and better discrimination ability in predicting post-procedural AR compared with manual measurement (p = 0.12, area under the curve 0.77, 95% confidence interval: 0.63 to 0.91, area under the curve 0.68, 95% confidence interval: 0.50 to 0.86, respectively). CONCLUSIONS: The automated 3mensio Valves software demonstrated reliable, reproducible aortic annulus measurement and better predictive value for post-procedural AR, suggesting important clinical implications for pre-operative assessment of patients undergoing TAVI.

Is EuroSCORE II better than EuroSCORE in predicting mortality after transcatheter aortic valve implantation?

OBJECTIVES: The purpose of this study was to examine the performance of the European system for cardiac operative risk evaluation II (ESII) in patients undergoing transcatheter aortic valve implantation (TAVI). BACKGROUND: The ESII was developed recently to improve the predictive value of the original logistic EuroSCORE (LES). METHODS: Between October 2006 and November 2011, 453 consecutive patients with severe aortic stenosis undergoing TAVI with either the Edwards valve or the Corevalve were included in the current analysis. The performance of the ESII, LES, and society of thoracic surgeons predicted risk of mortality score (STS) was evaluated. RESULTS: Mean age was 83.1 ± 6.4 years. The Edwards valve was used in 382 patients (84.3%) of the cohort, transfemoral approach (TF) in 55.0%, transapical approach (TA) in 25.2%, transaortic approach (TAo) 17.8%, transsubclabian approach (SC) 2.0%. The observed 30-day mortality was 12.6% (11.2, 18.4, 7.4, and 22.2% for TF, TA, TAo, SC, respectively). The mean LES, STS, and ESII were 22.4 ± 12.1, 8.1 ± 6.0, and 8.1 ± 5.2, respectively. The Hosmer-Lemeshow test showed ESII was inadequately calibrated for 30-day mortality compared with other risk scores (ESII P = 0.09, LES P = 0.84, STS P = 0.34). By using the area under the receiver operating characteristic curve (AUC), ESII better predicted 30-day mortality, albeit poorly, compared to LES and STS (AUC = 0.68, 0.65, and 0.60, respectively). In the TF cohort, ESII was better in predicting 30-day mortality compared to LES and STS (AUC = 0.74, 0.61, 0.60, respectively). CONCLUSIONS: Although the ESII demonstrated better predictive performance especially in the TF cohort, ESII is still inadequate in predicting mortality after TAVI as are LES and STS.