Transcatheter Aortic Valve Implantation in Japanese Patients With Large Annulus: The OCEAN-TAVI Registry.

Background: East Asians have smaller aortic valve complexes than individuals from Western countries, and few studies have reported transcatheter aortic valve implantation (TAVI) outcomes in Asian patients with a large annulus. Objectives: This study aimed to compare the short- and long-term outcomes of TAVI using balloon-expandable valves (BEVs) and self-expandable valves (SEVs) in Asian patients with a large annulus. Methods: The study retrospectively analyzed the data from the OCEAN-TAVI (Optimized Transcatheter Valvular Intervention Transcatheter Aortic Valve Implantation) registry. A large annulus was defined by an annular area ≥500 mm2 and an average diameter ≥25 mm as measured by computed tomography. The primary endpoint was 3-year all-cause mortality. Secondary endpoints were 3-year heart failure rehospitalization (HFR) after TAVI, short-term outcomes of TAVI, and changes in valve function 2 years after TAVI. Results: Among 773 patients, 671 underwent BEV TAVI. The SEV TAVI group showed a significantly higher incidence of greater than moderate paravalvular leakage (PVL) (P < 0.001), and an increased pacemaker implantation rate (P = 0.035). The incidence of prosthesis-patient mismatch did not differ between the 2 groups. The Kaplan-Meier curve showed no significant differences in 3-year all-cause mortality and HFR rates (log-rank P = 0.900), and echocardiographic valve function at 2 years post-TAVI did not differ between the 2 groups. Conclusions: The lack of differences in postoperative valve performance and long-term prognosis between BEV TAVI and SEV TAVI highlights the importance of selecting valves that can reduce the pacemaker implantation rate and PVL grade in the acute phase in patients with a large annulus. (Optimized Transcatheter Valvular Intervention Transcatheter Aortic Valve Implantation [OCEAN-TAVI]; UMIN000020423).

The value of the dynamic changes in cardiac power output in aortic stenosis patients following transcatheter aortic valve implantation: an exercise stress echocardiography study.

AIMS: Evidence for risk stratification using exercise stress echocardiography (ESE) in patients undergoing transcatheter aortic valve implantation (TAVI) for severe aortic stenosis (AS) is currently lacking. Cardiac power output (CPO) has demonstrated prognostic value in patients undergoing TAVI for severe AS. This study investigated prognoses in patients undergoing TAVI for severe AS and to explore the additional information that ESE can provide for risk stratification. METHODS: In this retrospective observational study, we included 96 consecutive patients who underwent TAVI for severe AS and patients with preserved left ventricular (LV) ejection fraction (≥ 50%) who underwent ESE at 3-6 months after TAVI. CPO was calculated as 0.222 × cardiac output × mean blood pressure/LV mass, where 0.222 was the conversion constant to W/100 g of the LV myocardium. All patients were followed up for all-cause mortality and hospitalization for heart failure. RESULTS: Of the 96 patients, 3 were excluded and 93 patients (82.0 years; 45.2% male) were included in this study. During a median follow-up period of 1446 (1271-1825) days, the composite end point was reached in 17 patients. Multivariable Cox regression analysis revealed that CPO at rest and the change in CPO from rest to exercise (ΔCPO) were independently associated with the composite end point (hazard ratio = 0.278, p = 0.023). The addition of ΔCPO resulted in an incremental value of the model containing clinical and resting echocardiography variables (p = 0.030). CONCLUSIONS: This study suggests that resting CPO and exercise-induced changes in CPO are useful for risk stratification of patients undergoing TAVI for severe AS.

Correlations Between Plasma BNP Level and Risk of Thrombotic-Hemorrhagic Events After Left Atrial Appendage Closure.

Background: Percutaneous left atrial appendage closure (LAAC) reduces the incidence of stroke/bleeding events in patients with non-valvular atrial fibrillation, high risk of stroke, and contraindication in continuing anticoagulation therapy. Of them, patients with heart failure may remain at high risk of these events after LAAC. Method: Patients who underwent LAAC and were listed for the multi-center, prospectively collected OCEAN-LAAC registry, were eligible. Of them, individuals without baseline plasma B-type natriuretic peptide (BNP) levels and those dependent on hemodialysis were excluded. The prognostic impact of baseline plasma BNP levels on the incidence of death or stroke/bleeding events after LAAC was evaluated. Results: A total of 937 patients (median 78 years, 596 men) were included. The LAAC device was successfully implanted in 934 (98%) patients. Over the 366 (251, 436) days after the LAAC, 148 patients encountered a primary outcome. The common logarithm of baseline plasma BNP was independently associated with the primary outcome with an adjusted hazard ratio of 1.46 (95% confidence interval 1.06-2.18, p = 0.043). A calculated cutoff of 2.12 (equivalent to 133 pg/mL of plasma BNP level) significantly stratified the cumulative incidence of the primary outcome (29% vs. 21% for 2 years, p = 0.004). Conclusions: Using prospectively collected large-scale multi-center Japanese registry data, we demonstrated that a baseline higher plasma BNP level was independently associated with a higher incidence of stroke/bleeding events and mortality after LAAC. Further studies are warranted to understand the optimal therapeutic strategy for LAAC candidates with elevated baseline plasma BNP levels.

Initial Findings Concerning the Latest Self-expandable Evolut FX Valve: A Report Using OCEAN-TAVI Registry Data.

Data concerning the clinical effect of the latest-generation self-expandable transcatheter heart valve (Evolut FX) remain limited. We aimed to assess the in-hospital outcomes of 3 bioprosthetic valves (Evolut EPO, PRO+, and FX). We analyzed data from a Japanese multicenter registry involving 634 consecutive patients who underwent transcatheter aortic valve replacement (TAVR) with Evolut FX up until October 2023. Patients who underwent TAVR with Evolut EPO between 2018 and 2020 (n = 1128), and those with Evolut EPO+ between 2020 and 2023 (n = 1696) served as control groups. Exclusion criteria comprised patients on dialysis, with a history of infective endocarditis, or with insufficient data. Unmatched comparisons among the 3 valves were conducted, followed by a propensity score (PS)-matched comparison between Evolut EPO+ and FX. In the unmatched cohort, among the Evolut EPO, PRO+, and FX groups, all vascular complications (7.8% vs. 5.2% vs. 4.5%, respectively; p < 0.01) and new pacemaker implantation (PMI) rates (11.2% vs. 6.1% vs. 7.7%, respectively; p < 0.01) differed significantly. In the PS-matched analysis, the rate of all bleeding events was significantly higher in the Evolut EPO+ group (11.0%) than in the FX group (7.0%) (p = 0.02), while all vascular complications (4.6% vs. 4.6%, respectively; p = 1.00) and new PMI (5.9% vs. 7.6%, respectively; p = 0.28) rates were comparable. The incidence of stroke in the FX group was approximately half that of the EP+ group (3.7% vs. 1.9%, p = 0.095) without statistical significance. In conclusion, compared with Evolut EPO+, Evolut FX was associated with a lower incidence of in-hospital bleeding complications and may reduce an in-hospital stroke incidence.

Imaging characteristics and clinical outcomes of hemodialysis vs. non-hemodialysis patients undergoing transcatheter aortic valve replacement: a Japanese single-center experience.

In 2021, Japan approved transcatheter aortic valve replacement (TAVR) for end-stage renal disease patients on hemodialysis (ESRD-HD). Yet, clinical/anatomical differences and outcomes between patients with and without ESRD-HD remain underexplored. This single-center study enrolled consecutive patients who underwent TAVR with the SAPIEN 3 between 2021 and 2023. Baseline characteristics and outcomes up to 1 year were compared. Inverse probability treatment weighting (IPTW) approach and Cox regression were used. Among 287 eligible patients, 59 had ESRD-HD. Patients with ESRD-HD were predominantly male (59.2% vs. 40.7%; p = 0.01), younger (78.0 [73.5-83.5] vs. 84.0 [79.8-88.0]; < 0.001), with lower body mass index (21.4 [19.6-23.3] vs. 22.9 [20.3-25.3]; p = 0.02], higher surgical risk (Society of Thoracic Surgeons Predicted Risk of Mortality ≧8%: 28 [47.5%] vs. 34 [14.9%]; p < 0.001), and more peripheral artery disease (25.4% vs. 4.8%; p < 0.001). Patients with ESRD-HD had a significantly higher prevalence of severely calcified femoral arteries (12.5% vs. 2.6%; p < 0.001). However, there were no differences in the computed-tomographic (CT) anatomical characteristics of the aortic valve complex (AVC), including the aortic valve calcium score (1995 [1372-3374] vs. 2195 [1380-3172]; p = 0.65) or the presence of moderate or severe left ventricular outflow tract calcification (4.3% vs. 5.2%; p > 0.99). Major vascular complications were rare, and technical (98.3% vs. 98.7%; p > 0.99) and device success (75.9% vs. 82.4%; p = 0.26) rates were high in both. At 1 year, there were no significant differences in a composite endpoint of death, stroke, major bleeding, or myocardial infarction (32.4% vs. 33.2%; HR 1.12; 95% CI 0.45-2.80; p = 0.81), nor its components after baseline adjustment.

Clinical Impact of Baseline Frailty Status and Residual Mitral Regurgitation After Transcatheter Edge-to-Edge Repair: Insights From the OCEAN-Mitral Registry.

BACKGROUND: The Clinical Frailty Scale (CFS) is a useful frailty marker for predicting clinical outcomes in patients undergoing invasive therapy. However, the clinical impact of CFS after transcatheter edge-to-edge repair in patients with mitral regurgitation (MR) remains unclear. This study aimed to elucidate the association between the baseline frail status defined by the CFS and clinical outcomes with or without postprocedural MR ≥2+ (post-MR ≥2+) after transcatheter edge-to-edge repair. METHODS AND RESULTS: Based on a Japanese multicenter registry (OCEAN [Optimized Catheter Valvular Intervention]-Mitral), data from 2078 patients with MR who underwent transcatheter edge-to-edge repair were analyzed. The patients were classified into 5 groups: CFS 1 to 3, 4, 5, 6, and ≥7. The procedural and clinical outcomes and post-MR ≥2+ were compared among the groups. All-cause mortality for up to 2 years was explored using Cox proportional hazards regression analysis. Although the rates of acute procedural success and post-MR ≥2+ were similar, all-cause mortality at 2 years was significantly increased across the 5 CFS categories (15.5%, 23.8%, 27.7%, 34.6%, and 48.8%, respectively, P<0.001). The incremental CFS categories and post-MR ≥2+ were independent predictive risk factors of all-cause mortality (all P<0.05). Among the patients with 5 CFS categories, the incidence of all-cause mortality was higher in those with post-MR ≥2+ than in those without (all P<0.05). CONCLUSIONS: Although prognosis was poor in patients with higher CFS grade after transcatheter edge-to-edge repair, minimizing modifiable factors of residual MR is warranted to improve the clinical outcomes. REGISTRATION INFORMATION: URL: https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000027188; Unique identifier: UMIN000023653.

Difference in Cardiac Response after Transcatheter Aortic Valve Implantation according to Flow and Gradient Pattern.

BACKGROUND: In patients undergoing transcatheter aortic valve implantation (TAVI) for severe aortic stenosis (AS), data on the differences in subsequent cardiac structure and function among stratified groups with flow gradient patterns through the aortic valve are insufficient. METHODS: In this large multicenter study, 4,523 patients undergoing TAVI for severe AS between 2013 and 2019 were divided into 3 groups according to the following criteria: (1) high-gradient AS (HG-AS) (mean pressure gradient [MPG] ≥40 mmHg), (2) classical low-flow low-gradient AS (cLFLG-AS) (MPG <40 mmHg, left ventricular [LV] ejection fraction [LVEF] <50%), and (3) paradoxical low-flow low-gradient AS (pLFLG-AS) (MPG <40 mmHg, LVEF ≥50% but stroke volume index [SVi] <35 mL/m2). Echocardiography was performed at baseline, post-procedure, and 1 year post-TAVI. RESULTS: 3,697, 507, and 319 patients had HG-AS, cLFLG-AS, and pLFLG-AS, respectively. After adjusting for clinical factors, cLFLG-AS and pLFLG-AS had an approximately 1.5-fold higher 2-year all-cause mortality compared with HG-AS. During 1 year following TAVI, compared with HG-AS, cLFLG-AS showed greater reduction of LV systolic diameter (LVDs) and LV diastolic diameter (LVDd) and greater increase of LVEF (p<0.001 for all), and changes in LV mass index (LVMi) and SVi were comparable (p=0.915 and p=0.821, respectively). However, pLFLG-AS demonstrated less reduction of LVDs and LVDd (p=0.039 and p=0.001, respectively), less improvement of LVEF and LVMi (p=0.045 and p<0.001, respectively), and comparable change in SVi (p=0.364). CONCLUSIONS: During 1 year post-TAVI, compared with HG-AS, cLFLG-AS achieves smaller LV diameters, greater increase in LVEF, and comparable regression of LVMi, whereas pLFLG-AS does not.

Impact of beta-blocker uptitration on patients after transcatheter edge-to-edge mitral valve repair for secondary mitral regurgitation: The OCEAN-mitral registry.

BACKGROUND: Optimal medical therapy for patients with secondary mitral regurgitation (SMR) undergoing transcatheter edge-to-edge mitral valve repair (M-TEER) remains unclear. This study aimed to investigate the association between beta-blocker uptitration and clinical outcomes after M-TEER. METHODS: Using data from the Japanese multicenter registry, we examined 1474 patients who underwent M-TEER for SMR between April 2018 and June 2021. Beta-blocker uptitration was defined as an increased dose of beta-blockers 1 month after M-TEER compared with that before M-TEER. The 2-year clinical outcomes were compared between patients with and without beta-blocker uptitration, utilizing multivariable Cox regression analyses and propensity score matching (PSM). RESULTS: Of the 1474 patients who underwent M-TEER, 272 (18.4 %) were receiving increasing doses of beta-blockers at the 1-month follow-up. These patients had lower left ventricular ejection fraction (LVEF) and higher B-type natriuretic peptide levels. Most patients in the beta-blocker uptitration group received less than the target dose of beta-blockers. Multivariable Cox regression analyses showed that beta-blocker uptitration was significantly associated with a lower risk of all-cause (adjusted hazard ratio [HR]: 0.55; 95 % confidence interval [CI]: 0.36-0.84; P = 0.006) and cardiovascular mortalities (adjusted HR: 0.45, 95 % CI: 0.26-0.79, P = 0.006). PSM analyses revealed consistent findings. Subgroup analyses revealed a significant interaction between beta-blocker uptitration and LVEF≤40 % (interaction P = 0.018). CONCLUSIONS: In patients with SMR, beta-blocker uptitration after M-TEER was associated with better clinical outcomes, especially in the group with an LVEF≤40 %. Efforts to uptitrate guideline-directed medical therapy after M-TEER for SMR may be necessary, even if reaching the target dose proves challenging.

Prognostic impact of being underweight in patients undergoing mitral TEER: The OCEAN-Mitral registry.

AIMS: Mitral transcatheter edge-to-edge repair (M-TEER) is a valid treatment option for severe mitral regurgitation (MR), necessitating accurate risk stratification of M-TEER candidates for effective patient selection, optimal periprocedural care and improved long-term outcomes. The body mass index (BMI) is a simple and practical prognostic index, and the obesity paradox has been widely reported. METHODS AND RESULTS: Between April 2018 and June 2021, 2149 patients undergoing M-TEER were registered in the prospective multicentre registry and classified into three groups: underweight (BMI < 18.5 kg/m2), normal weight (18.5 â‰¦ BMI < 25 kg/m2) and overweight and obese (25 kg/m2 â‰¦ BMI). The impact of underweight on the all-cause, cardiovascular and non-cardiovascular mortality following M-TEER was evaluated [follow-up duration: 436 (363-733) days]. The participants (median BMI: 21.1 kg/m2) were categorized as underweight (n = 450, 20.9%), normal weight (n = 1409, 65.6%) and overweight and obese (n = 290, 13.5%). Compared with the other two groups, the underweight group exhibited several negative prognostic factors, including older age, frailty, no dyslipidaemia, hypoalbuminaemia, residual MR and non-home discharge. Underweight patients had the highest rate of all-cause, cardiovascular and non-cardiovascular mortality, whereas those in the other two groups were similar. As per the multivariate analysis, underweight itself was associated with all-cause mortality (hazard ratio: 1.52, 95% confidence interval: 1.17-1.97, P = 0.009) and cardiovascular mortality (hazard ratio: 1.45, 95% confidence interval: 1.04-2.01, P = 0.028). CONCLUSIONS: Underweight patients had the highest mortality rate after M-TEER. Comorbidities, residual MR, discharge disposition and underweight status were correlated with postprocedural outcome.

Mismatch Between Residual Mitral Regurgitation and Left Atrial Pressure Predicts Prognosis After Transcatheter Edge-to-Edge Repair.

BACKGROUND: The mechanism and impact of mismatch between residual mitral regurgitation (MR) and postprocedural left atrial pressure (LAP) after transcatheter edge-to-edge repair (TEER), which may adversely affect clinical outcome, is of great interest. OBJECTIVES: This study aimed to examine the effect of hemodynamic mismatch after TEER on clinical outcomes in patients with heart failure due to severe MR and investigate the predictive factors for the mismatch using a prospective multicenter registry. METHODS: We categorized 1,477 patients into optimal (residual MR grade ≤1 and postprocedural LAP ≤15 mm Hg), mismatched (residual MR grade >1 or postprocedural LAP >15 mm Hg), and poor (residual MR grade >1 and postprocedural LAP >15 mm Hg) groups and examined their prognosis. The primary endpoint was a composite of all-cause mortality and heart failure hospitalization. RESULTS: There were 927 (62.7%), 459 (31.1%), and 91 (6.2%) patients categorized into optimal, mismatched, and poor groups, respectively. Cox regression analysis, referenced to the optimal group, revealed that the mismatched and poor groups exhibited a higher risk for the primary endpoint (HR: 1.55; 95% CI: 1.28-1.88; and HR: 1.95; 95% CI: 1.38-2.74, respectively). Six risk factors were identified as predictors of hemodynamic mismatch after TEER: body mass index, baseline left atrial volume index, atrial fibrillation, tricuspid annular plane systolic excursion value, preprocedural mean left atrial pressure, and postprocedural mean mitral valve pressure gradient. CONCLUSIONS: Post-TEER hemodynamic mismatch between residual MR and postprocedural LAP was associated with a poor prognosis. Six readily accessible perioperative parameters predict the hemodynamic mismatch. (OCEAN-Mitral registry; UMIN000023653).

Initial Results of Intra-Annular Self-Expandable Valves: Insights From the OCEAN-TAVI Registry.

Background: Navitor, an intra-annular self-expanding heart valve (IA-SEV), is the third transcatheter heart valve introduced in Japan (in April 2022) as the next generation of the Portico valve ahead of other Asian countries. Objectives: The purpose of this study was to assess the patient-prosthesis mismatch (PPM) after IA-SEV implantation in Asian patients. Methods: All clinical data were collected from the database of an ongoing prospective Japanese multicenter registry (OCEAN-TAVI [Optimised Catheter Valvular Intervention transcatheter aortic valve implantation]). The primary endpoint was the rate of no PPM; the secondary endpoint included the rate of in-hospital mortality and hemodynamics after IA-SEV implantation. Results: A total of 463 patients (median age 86; 69.7% female) were enrolled in the registry. The percentages of implanted valves sized 23 mm, 25 mm, 27 mm, and 29 mm were 26.1% (n = 121), 41.7% (n = 193), 22.9% (n = 106), and 9.3% (n = 43), respectively. The primary endpoint of no PPM was achieved in 91.7% of the entire cohort and in 87.3%, 94.2%, 91.4%, and 93.0% of each valve size. The rate of in-hospital mortality was 1.9%. Postprocedural mean pressure gradient was 8.3 ± 4.3 mm Hg. The overall rate of pacemaker implantation was 9.7%; the incidence of pacemaker rate tended to be reduced when dividing the first and second half of operator experiences (13.0% vs. 8.0%; P = 0.08). Conclusions: The initial results for the IA-SEV were excellent regarding hemodynamics and reduction of paravalvular leakage regardless of valve size. The IA-SEV is a useful transcatheter heart valve, especially for Asian patients with a high prevalence of small annulus.

The Multicenter STudy On a Precise algorithm for diagnosis of heart failure with preserved ejection fraction, STOP-HFPEF study: study protocol and design.

This study aims to develop a new heart failure with preserved ejection fraction (HFpEF) diagnostic algorithm tailored to Asian populations, addressing limitations of current diagnostic models. Existing HFpEF diagnostic algorithms primarily target patients with dyspnea and metabolic comorbidities, such as obesity, which are more prevalent in Western populations. However, in Asian countries, HFpEF cases are less frequently associated with obesity, leading to less prominent dyspnea and more noticeable symptoms such as fatigue. By incorporating exercise stress echocardiography and focusing on early-stage HFpEF, particularly in patients with symptoms beyond dyspnea, we seek to enable early diagnosis and intervention, ultimately extending healthy life expectancy and improving quality of life. The STOP-HFPEF (The Multicenter STudy On a Precise algorithm for diagnosis of Heart Failure with Preserved Ejection Fraction) study is a multicenter prospective observational investigation in Japan. Certified by the Japanese Society of Echocardiography, the study includes participants aged 20 and older who undergo exercise stress echocardiography. The primary goal is to develop a scoring model for diagnosing HFpEF in heart-failure stages A, B, and C. Secondary outcomes will assess the clinical utility of the new diagnostic score by comparing heart-failure incidence, cardiovascular events, and mortality rates.Study registration: Registered at the UMIN registry (UMIN000054565) on 1 July 2024.

R2-CHA2DS2-VASc Score for Cardiovascular Event Prediction After Bioprosthetic Valve Replacement　- Subanalysis From the BPV-AF Registry.

Background: There are few studies evaluating the prognostic prediction method in atrial fibrillation (AF) patients after bioprosthetic valve (BPV) replacement. The R2-CHA2DS2-VASc score is increasingly used for the prediction of cardiovascular (CV) events in patients with AF, device implantation, and acute coronary syndrome. We aimed to evaluate the predictive value of the R2-CHA2DS2-VASc score for future CV events in AF patients after BPV replacement. Methods and Results: The BPV-AF, an observational, multicenter, prospective registry, enrolled AF patients who underwent BPV replacement. The primary outcome measure was a composite of stroke, systemic embolism, CV events including heart failure requiring hospitalization, and cardiac death. A total of 766 patients was included in the analysis. The mean R2-CHA2DS2-VASc score was 5.7±1.8. Low (scores 0-1), moderate (scores 2-4), and high (scores 5-11) R2-CHA2DS2-VASc score groups consisted of 12 (1.6%), 178 (23.2%), and 576 (75.2%) patients, respectively. The median follow-up period was 491 (interquartile range 393-561) days. Kaplan-Meier analysis showed a higher incidence of the composite CV events in the high R2-CHA2DS2-VASc score group (log rank test; P<0.001). Multivariate Cox proportional hazards regression analysis revealed that the R2-CHA2DS2-VASc score as a continuous variable was an independent predictor of composite CV outcomes (hazard ratio 1.36; 95% confidence interval 1.18-1.55; P<0.001). Conclusions: The R2-CHA2DS2-VASc score is useful for CV risk stratification in AF patients after BPV replacement.

Transcatheter aortic valve implantation for combined aortic and mitral stenoses: Insights from the OCEAN-TAVI Registry.

AIMS: Mitral stenosis (MS) occasionally coexists with aortic stenosis (AS). Limited data are available regarding the functional class and clinical outcomes of patients who undergo transcatheter aortic valve implantation (TAVI) for combined AS and MS. This study compared the clinical outcomes in patients with and without MS who underwent TAVI for severe AS and assessed the impact of mitral annulus calcification (MAC) severity, transmitral gradient (TMG) and mitral valve area (MVA) on outcomes in patients with combined AS and MS. METHODS: We investigated patients in the OCEAN-TAVI registry who underwent TAVI. MS was defined as an MVA ≤ 1.5 cm2 or TMG ≥ 5 mmHg. The composite of all-cause death and admission for heart failure was compared between patients with and without MS. The impact of MAC, TMG and MVA on outcomes was assessed in patients with combined AS and MS. RESULTS: We identified 106 patients with MS (MAC 84%; TMG 6.4 ± 2.6 mmHg; MVA 1.10 ± 0.31 cm2) and 6570 without MS as controls. The MS group was older (85 ± 5 vs. 84 ± 5 years, P = 0.033), more of women (85 vs. 67%, P < 0.01), and had a higher risk of surgery (the Society of Thoracic Surgeons Mortality Score 8.7 ± 5.1 vs. 7.6 ± 5.9, P = 0.047) than the controls. In the MS group, the New York Heart Association Functional Class was 3 or 4 in 56% of the patients at baseline and 6% at 1 year after TAVI. Thirty-day mortality (2.8% vs. 1.3%, P = 0.18) and early composite outcomes (17% vs. 15%, P = 0.56) were comparable between patients with and without MS. During a median follow-up of 2.1 years, the presence of MS was associated with a higher incidence of adverse events compared with controls (adjusted hazard ratio [HR] 1.84; 95% confidence interval [CI] 1.34-2.51, P < 0.01), even on propensity score matched analysis (adjusted HR 1.91; 95% CI 1.14-3.22, P < 0.01). Moderate or severe MAC contributed to increased risk of adverse events in patients with MS (adjusted HR 2.89; 95% CI 1.20-6.99, P = 0.018), but TMG and MVA did not. CONCLUSIONS: In patients undergoing TAVI for severe AS, those with moderate or severe MS experienced worse outcomes after TAVI compared with those without MS. Patients with combined AS and MS sustained symptom improvement at 1-year post-TAVI. MAC severity was a useful predictor of adverse events compared with MS haemodynamics such as TMG and MVA in patients with combined AS and MS.

Multicenter validation study for automated left ventricular ejection fraction assessment using a handheld ultrasound with artificial intelligence.

We sought to validate the ability of a novel handheld ultrasound device with an artificial intelligence program (AI-POCUS) that automatically assesses left ventricular ejection fraction (LVEF). AI-POCUS was used to prospectively scan 200 patients in two Japanese hospitals. Automatic LVEF by AI-POCUS was compared to the standard biplane disk method using high-end ultrasound machines. After excluding 18 patients due to infeasible images for AI-POCUS, 182 patients (63 ± 15 years old, 21% female) were analyzed. The intraclass correlation coefficient (ICC) between the LVEF by AI-POCUS and the standard methods was good (0.81, p < 0.001) without clinically meaningful systematic bias (mean bias -1.5%, p = 0.008, limits of agreement ± 15.0%). Reduced LVEF < 50% was detected with a sensitivity of 85% (95% confidence interval 76%-91%) and specificity of 81% (71%-89%). Although the correlations between LV volumes by standard-echo and those by AI-POCUS were good (ICC > 0.80), AI-POCUS tended to underestimate LV volumes for larger LV (overall bias 42.1 mL for end-diastolic volume). These trends were mitigated with a newer version of the software tuned using increased data involving larger LVs, showing similar correlations (ICC > 0.85). In this real-world multicenter study, AI-POCUS showed accurate LVEF assessment, but careful attention might be necessary for volume assessment. The newer version, trained with larger and more heterogeneous data, demonstrated improved performance, underscoring the importance of big data accumulation in the field.

Prognostic value of extraaortic-valvular cardiac damage in patients with moderate aortic stenosis and reduced left ventricular ejection fraction.

PURPOSE: The extraaortic-valvular cardiac damage (EVCD) Stage has shown potential for risk stratification for patients with aortic stenosis (AS). This study aimed to examine the usefulness of the EVCD Stage in risk stratification of patients with moderate AS and reduced left ventricular ejection fraction (LVEF). METHODS: Clinical data from patients with moderate AS (aortic valve area, .60-.85 cm2/m2; peak aortic valve velocity, 2.0-4.0 m/s) and reduced LVEF (LVEF 20%-50%) were analyzed during 2010-2019. Patients were categorized into three groups: EVCD Stages 1 (LV damage), 2 (left atrium and/or mitral valve damage), and 3/4 (pulmonary artery vasculature and/or tricuspid valve damage or right ventricular damage). The primary endpoint included a composite of cardiac death and heart failure hospitalization, with non-cardiac death as a competing risk. RESULTS: The study included 130 patients (mean age 76.4 ± 6.8 years; 62.3% men). They were categorized into three groups: 26 (20.0%) in EVCD Stage 1, 66 (50.8%) in Stage 2, and 48 (29.2%) in Stage 3/4. The endpoint occurred in 54 (41.5%) patients during a median follow-up of 3.2 years (interquartile range, 1.4-5.1). Multivariate analysis indicated EVCD Stage 3/4 was significantly associated with the endpoint (hazard ratio 2.784; 95% confidence interval 1.197-6.476; P = .017) compared to Stage 1, while Stage 2 did not (hazard ratio 1.340; 95% confidence interval .577-3.115; P = .500). CONCLUSION: The EVCD staging system may aid in the risk stratification of patients with moderate AS and reduced LVEF.

Cardiac power output is associated with adverse outcomes in patients with preserved ejection fraction after transcatheter aortic valve implantation.

Aims: Cardiac power output (CPO) measures cardiac performance, and its prognostic significance in heart failure with preserved ejection fraction (EF) has been previously reported. However, the effectiveness of CPO in risk stratification of patients with valvular heart disease and post-operative valvular disease has not been reported. We aimed to determine the association between CPO and clinical outcomes in patients with preserved left ventricular (LV) EF after transcatheter aortic valve implantation (TAVI). Methods and results: This retrospective observational study included 1047 consecutive patients with severe aortic stenosis after TAVI. All patients were followed up for all-cause mortality and hospitalization for HF. CPO was calculated as 0.222 × cardiac output × mean blood pressure (BP)/LV mass, where 0.222 was the conversion constant to W/100 g of the LV myocardium. CPO was assessed using transthoracic echocardiography at discharge after TAVI. Of the 1047 patients, 253 were excluded following the exclusion criteria, including those with low LVEF, and 794 patients (84.0 [80.0-88.0] years; 35.8% male) were included in this study. During a median follow-up period of 684 (237-1114) days, the composite endpoint occurred in 196 patients. A dose-dependent association was observed between the CPO levels and all-cause mortality. Patients in the lowest CPO tertile had significantly lower event-free survival rates (log-rank test, P = 0.043). Multivariate Cox regression analysis showed that CPO was independently associated with adverse outcomes (hazard ratio = 0.561, P = 0.020). CPO provided an incremental prognostic effect in the model based on clinical and echocardiographic markers (P = 0.034). Conclusion: CPO is independently and incrementally associated with adverse outcomes in patients with preserved LVEF following TAVI.

Prognostic impact of increase in left atrial volume following left atrial appendage closure: Insights from the OCEAN-LAAC registry.

Background: Percutaneous left atrial appendage closure (LAAC) is an effective therapy to prevent thromboembolic events among patients with atrial fibrillation (AF). However, since the left atrial appendage (LAA) contributes to left atrial volume and serves as a buffer for increasing left atrial pressure, this procedure may impair left atrium (LA) compliance, enlarge LA, and deteriorate diastolic function. In this study, we sought to investigate the change in left atrial volume index (LAVI) following LAAC and its effect on prognosis. Methods and Results: We analyzed 225 patients from the OCEAN-LAAC registry, an ongoing, multicenter Japanese study. Comparing LAVI measurements at baseline and 6 months after LAAC, no significant increase was observed (55.0 [44.0, 70.0] ml/m2 vs. 55.0 [42.0, 75.6] ml/m2; P = 0.31). However, some patients underwent LAVI increase. Particularly, a smaller LAVI (odds ratio [OR]: 0.98 [95 % confidence interval (CI): 0.97-0.996]) and elevated tricuspid regurgitation pressure (TRPG) at baseline (OR: 1.04 [95 % CI: 1.00 - 1.08]) were significantly related to the increase in LAVI at 6-month follow-up. In addition, a 5 ml/m2 increase in LAVI was significantly associated with subsequent heart failure hospitalization (HFH) (hazard ratio: 3.37 [95 % CI: 1.18-9.65]). This association, however, was not observed in patients with lower baseline LAVI (≤55 ml/m2) but was only seen in those with a baseline LAVI over 55 ml/m2. Conclusion: Our study demonstrated an increase in LAVI after LAAC was related to smaller LAVI or elevated TRPG at baseline. The LAVI increase was significantly associated with subsequent HFH.

Clinical effects of direct oral anticoagulants in elderly patients with a bioprosthetic valve and atrial fibrillation.

BACKGROUND: Current guidelines recommend direct oral anticoagulants (DOACs) and warfarin for patients with atrial fibrillation (AF) who have a bioprosthetic valve (BPV). However, the data related to elderly patients (aged ≥80 years) with BPV replacement and AF are limited. METHODS: This post-hoc subgroup analysis of a BPV-AF Registry enrolled 752 patients with BPV replacement and AF. The primary net outcome was a composite of cardiac death, stroke, systemic embolism, major bleeding, and cardiovascular events. RESULTS: Among 752 patients, 429 (57%) patients were ≥ 80 and 323 (43%) were < 80 years old. The higher risk in patients aged ≥80 than <80 years was significant for the net outcome (hazard ratio [HR], 2.04; 95% confidence interval [CI], 1.31-3.17; P = 0.001). After adjustment for confounders, there was no statistically significant difference between warfarin (reference) and DOAC users in the risk of net outcomes (adjusted HR, 1.26; 95% CI, 0.71-2.24; P = 0.44), stroke and systemic embolism (adjusted HR, 2.01; 95% CI, 0.48-8.38; P = 0.34), and major bleeding (adjusted HR, 0.73; 95% CI, 0.11-4.98; P = 0.75) in patients aged ≥80 years old as well as those aged <80 years. Among 489 warfarin users, the cumulative incidence of net outcomes tended to be higher in patients aged ≥80 than <80 years (12.2% vs. 5.7% at 1 year, log-rank P = 0.002). Among 263 DOAC users, however, it was similar between patients aged ≥80 and < 80 years. CONCLUSIONS: The present study demonstrated that DOAC showed similar efficacy and safety compared with warfarin even in elderly patients aged ≥80 years with BPV replacement and AF.