Cost-effective analysis of transcatheter aortic valve replacement in patients with severe symptomatic aortic stenosis: A prospective multicenter study.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) for severe symptomatic aortic stenosis (AS) does not benefit all patients. We performed a prospective multicenter study to investigate the cost-effectiveness of TAVR in a Japanese cohort. METHODS AND RESULTS: We prospectively enrolled 110 symptomatic patients with severe AS who underwent TAVR from five institutions. The quality of life measurement (QOL) was performed for each patient before and at 6 months after TAVR. Patients without an improvement in QOL at 6 months after TAVR were defined as non-responders. Pre-TAVR higher QOL, higher clinical frailty scale predicted the non-responders. Three models, 1) conservative treatment for all patients strategy, 2) TAVR for all patients strategy, and 3) TAVR for a selected patient strategy who is expected to be a responder, were simulated. Lifetime cost-effectiveness was estimated using incremental cost-effectiveness ratio (ICER) and cost per quality-adjusted life-year (QALY) gained. In comparison to conservative therapy for all patients, ICER was estimated to be 5,765,800 yen/QALY for TAVR for all patients and 2,342,175 yen/QALY for TAVR for selected patient strategy patients, which is less than the commonly accepted ICER threshold of 5,000,000 yen/QALY. CONCLUSIONS: TAVR for selected patient strategy model is more cost-effective than TAVR for all patient strategy without reducing QOL in the Japanese healthcare system. TAVR for selected patient strategy has potential benefit for optimizing the TAVR treatment in patients with high frailty and may direct our resources toward beneficial interventions.

Additive value of the right parasternal view for the assessment of aortic stenosis.

BACKGROUND: Although Doppler evaluation using a multiplanar method is recommended to assess the severity of aortic stenosis (AS) with transthoracic echocardiography, evidence on the diagnostic significance of a non-apical method is limited. This study aimed to compare the use of the apical with the use of the right parasternal view (RPV) method to evaluate AS severity and to examine the diagnostic significance of performing the RPV method in addition to the apical method during the evaluation. METHODS: This retrospective observational study included 276 consecutive patients (mean age: 79 ± 10 years; women, 56%) with severe AS (aortic valve area [AVA] ≤1.0cm2 ). The severity of AS according to the apical method and that according to the RPV for all subjects were compared, and the significance of performing the RPV method in addition to the apical method was examined. Furthermore, we compared the concordance group, in which the apical and RPV methods indicated matching in severity, and the discordant group, in which the apical and RPV methods did not indicate matching severity. RESULTS: Peak velocity (Vmax ), mean pressure gradient (MG) were significantly higher and the AVA, AVAi, and Doppler velocity index (DVI) were significantly smaller when the RPV was added to the apical view. Performing the RPV method in addition to the apical method significantly decreased the number of low PG AS cases (MG < 40 mmHg) from 69.9% to 65.0% and it increased the number of very severe AS cases (Vmax ≥ 5 m/s) from 8.7% to 14.5%. Deviation of Doppler angle was significantly greater in the discordant group compared to the concordant group (22.5 ± .6 vs. 31.8 ± 1.7, p < .001). CONCLUSIONS: By performing the RPV method in addition to the apical method to determine AS severity, the diagnosis of AS to be resolved in approximately 10% of cases. These results suggest that AS severity may be underestimated by using the apical method alone.

Association of PM2.5 exposure with hospitalization for cardiovascular disease in elderly individuals in Japan.

Although exposure to particulate matter with aerodynamic diameters ≤ 2.5 µm (PM2.5) influences cardiovascular disease (CVD), its association with CVD-related hospitalizations of super-aged patients in Japan remains uncertain. We investigated the relationship between short-term PM2.5 exposure and CVD-related hospitalizations, lengths of hospital stays, and medical expenses. We analyzed the Japanese national database of patients with CVD (835,405) admitted to acute-care hospitals between 2012 and 2014. Patients with planned hospitalizations and those with missing PM2.5 exposure data were excluded. We classified the included patients into five quintiles based on their PM2.5 exposure: PM-5, -4, -3, -2, and -1 groups, in descending order of concentration. Compared with the PM-1 group, the other groups had higher hospitalization rates. The PM-3, -4, and -5 groups exhibited increased hospitalization durations and medical expenses, compared with the PM-1 group. Interestingly, the hospitalization period was longer for the ≥ 90-year-old group than for the ≤ 64-year-old group, yet the medical expenses were lower for the former group. Short-term PM2.5 exposure is associated with increased CVD-related hospitalizations, hospitalization durations, and medical expenses. The effects of incident CVDs were more marked in elderly than in younger patients. National PM2.5 concentrations should be reduced and the public should be aware of the risks.

Prognostic value of Mini Nutritional Assessment-Short Form with aortic valve stenosis following transcatheter aortic valve implantation.

AIMS: Older adults at risk for malnutrition are known to have a high mortality rate. This study aimed to investigate whether the Mini Nutritional Assessment-Short Form (MNA-SF) could predict midterm mortality in patients undergoing transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: We applied the MNA-SF in 288 patients who had undergone TAVI from January 2016 to June 2019 at the St. Marianna University School of Medicine hospital. Using the MNA-SF cut-off value to indicate the risk of malnutrition, patients were divided into two groups, namely, those with an MNA-SF score ≤11 (impaired MNA-SF group) and those with an MNA-SF score ≥12 (maintained MNA-SF group). We used this value to investigate the association between the MNA-SF and all-cause mortality. Overall, 188 (65%) and 100 (35%) patients comprised the impaired MNA-SF and maintained MNA-SF groups, respectively, and 41 patients died after TAVI (mean follow-up duration, 458 ± 315 days). Kaplan-Meier analyses showed that patients in the impaired MNA-SF group had a significantly higher incidence of all-cause mortality (hazard ratio 2.67; 95% confidence interval 1.29-6.21; P = 0.01). Multivariate Cox regression analyses showed that the MNA-SF score was an independent predictor of all-cause mortality after adjusting for the Society of Thoracic Surgeons risk score, Katz Index, and brain natriuretic peptide test results (hazard ratio 1.14; 95% confidence interval 1.01-1.28; P = 0.04). CONCLUSIONS: The MNA-SF was useful to screen for the risk of malnutrition in patients with TAVI and in predicting midterm prognoses in patients undergoing TAVI and could predict patient mortality after the procedure.

Endothelialization of an Amplatzer Septal Occluder Device 6 Months Post Implantation: Is This Enough Time? An In Vivo Angioscopic Assessment.

The current guidelines recommend a minimum of 6 months of antithrombotic and antibiotic prophylaxis following septal occluding device placement for transcatheter closure of atrial septal defect. Full neoendothelialization is thought to be completed within 6 months of device implantation; however, there is no method available that can assess the level of neoendothelialization in vivo. This report therefore evaluates endothelialization in vivo and demonstrates that 6 months of postimplantation prophylactic therapy may not provide sufficient time for adequate endothelialization. Further investigations are warranted to determine the optimal duration of these treatments after atrial septal defect closure.

Single Versus Standard Multiview Assessment of Global Longitudinal Strain for the Diagnosis of Cardiotoxicity During Cancer Therapy.

OBJECTIVES: The goal of this study was to compare echocardiographic measurements of global longitudinal strain (GLS) (using 3 apical views) with single-view longitudinal strain (LS, 4- or 2-chamber [4CV_LS and 2CV_LS, respectively]) for detection of cancer-therapy related cardiotoxicity. BACKGROUND: GLS is useful for the detection of cardiotoxicity, but the need for repeated measurements poses a significant burden on busy echocardiography laboratories. A single-view LS measurement, possibly at point of care, could improve efficiency. METHODS: Seventeen international centers prospectively recruited 108 patients (mean age 54 ± 13 years) at high risk for cardiotoxicity as part of the ongoing SUCCOUR (Strain Surveillance for Improving Cardiovascular Outcomes During Chemotherapy) randomized controlled trial. Echocardiography performed at baseline and follow-up were analyzed in a core laboratory setting blinded to clinical information. Peak systolic GLS and LS were measured from raw data. Cardiotoxicity was defined by reduction in left ventricular ejection fraction >0.10 to <0.55 or a relative drop in GLS by ≥12%. RESULTS: Cardiotoxicity developed in 46 patients by either criteria. Baseline and follow-up 2-dimensional left ventricular ejection fraction were 61 ± 4% and 58 ± 5%, respectively (p < 0.001). The baseline GLS (-20.9 ± 2.4%) was not different from 4CV_LS (-20.7 ± 2.5%; p = 0.09) or 2CV_LS (-21.1 ± 3.1%; p = 0.25). The follow-up GLS (-19.5 ± 2.4%) was also similar to 4CV_LS (-19.5 ± 2.6%; p = 0.80) and 2CV_LS (-19.7 ± 3.1%; p = 0.19). There was good correlation between GLS and 4CV_LS at baseline (r = 0.86; p < 0.001) and follow-up (r = 0.89; p < 0.001) and with 2CV_LS at baseline (r = 0.87; p < 0.001) and follow-up (r = 0.88; p < 0.001). However, there was 15% to 22% disagreement between GLS and 4CV_LS or 2CV_LS for the detection of cardiotoxicity. The interobserver and intraobserver reproducibility was higher for GLS (intraclass correlation: 0.93 to 0.95; coefficient of variance: 2.9% to 3.7%) compared with either single-chamber-based LS measurement (intraclass correlation: 0.85 to 0.91; coefficient of variance: 4.1% to 4.8%). CONCLUSIONS: Although there was good correlation between GLS and single-view LS measurements, single-view LS measurement led to disagreement in the diagnosis of cardiotoxicity in up to 22% of patients. GLS measurements were more reproducible than single-view LS. GLS based on 3 apical views should remain the preferred technique for detection of cardiotoxicity. (Strain Surveillance for Improving Cardiovascular Outcomes During Chemotherapy [SUCCOUR]; ACTRN12614000341628).

Reduced variability of visual left ventricular ejection fraction assessment with reference images: The Japanese Association of Young Echocardiography Fellows multicenter study.

BACKGROUND: Visual estimation of left ventricular ejection fraction (LVEF) is widely applied to confirm quantitative EF. However, visual assessment is subjective, and variability may be influenced by observer experience. We hypothesized that a learning session might reduce the misclassification rate. METHODS: Protocol 1: Visual LVEFs for 30 cases were measured by 79 readers from 13 cardiovascular tertiary care centers. Readers were divided into 3 groups by their experience: limited (1-5 years, n=28), intermediate (6-11 years, n=26), and highly experienced (12-years, n=25). Protocol 2: All readers were randomized to assess the effect of a learning session with reference images only or feedback plus reference images. After the session, 20 new cases were shown to all readers following the same methodology. To assess the concordance and accuracy pre- and post-intervention, each visual LVEF measurement was compared to overall average values as a reference. RESULTS: Experience affected the concordance in visual EF values among the readers. Groups with intermediate and high experience showed significantly better mean difference (MD), standard deviation (SD), and coefficient of variation (CV) than those with limited experience at baseline. The learning session with reference image reduced the MD, SD, and CV in readers with limited experience. The learning session with reference images plus feedback also reduced proportional bias. Importantly, the misclassification rate for mid-range EF cases was reduced regardless of experience. CONCLUSION: This large multicenter study suggested that a simple learning session with reference images can successfully reduce the misclassification rate for LVEF assessment.