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Objectives To evaluate the effectiveness of CT before TAVI using variable helical pitch (VHP) scanning and its diagnostic performance for coronary artery disease (CAD). Methods Sixty patients (84.4 ± 4.6 years) scheduled for TAVI underwent CT using VHP scanning with the contrast material (CM) volume calculated as scanning time × weight [kg] × 0.06 mL. Retrospective electrocardiography (ECG)-gated scanning was utilized to examine the thorax, and non-ECG-gated scanning of the abdomen immediately followed. We analyzed CT attenuation values of the coronary arteries, aorta, iliac and femoral arteries. The coronary CT angiography images were evaluated for the presence of stenosis (≥50 %); invasive coronary angiography served as a reference standard. Results The average attenuations of all of the arteries were greater than 400 HU. We could evaluate the peripheral access vessels and dimensions of the ascending aorta, aortic root, and aortic annulus in all patients. The average volume of CM was 38.7 ± 8.5 mL. On per-patient and vessel analysis, CT showed 91.7 % and 89.5 % sensitivity, and 91.3 % and 97.4 % negative predictive value (NPV). Conclusions CT using VHP scanning with an average CM volume of 38.7 mL is useful before TAVI and had a high sensitivity and NPV in excluding obstructive CAD. Key Points • TAVI-planning CT using variable helical pitch (VHP) scanning is useful. • The average volume of contrast material was 38.7 ± 8.5 mL. • The average attenuations of all the arteries were >400 HU. • This CT had a high sensitivity and NPV for excluding obstructive CAD.

•The STS score was designed to predict 30-day mortality after cardiac surgery.•Lower mortality after transcatheter aortic valve implantation than was predicted.•High STS score is associated with an increased risk of long-term mortality.•Similar long-term mortality in patients with low and intermediate scores. The Society of Thoracic Surgeons (STS) risk model, designed to predict operative mortality after cardiac surgery, is often used for the risk assessment of patients considered for transcatheter aortic valve implantation (TAVI). We investigated the long-term prognostic value of the STS score by utilizing the data of 2588 patients undergoing TAVI from the OCEAN (Optimized CathEter vAlvular iNtervention)—TAVI Japanese multicenter registry. The patients were divided into 3 groups according to their pre-procedural STS score as follows: low-risk (STS score <4%, n = 467 [18%]), intermediate-risk (4%≤ STS score <8%, n = 1200 [46.4%]), and high-risk (8%≤ STS score, n = 921 [35.6%]). Low-risk patients were younger and were more frequently male. The prevalence of most of the comorbidities were higher in high-risk patients, while active cancer was more frequent in low-risk patients (p <0.001).The cumulative 4-year all-cause mortality rates were higher in high-risk patients (49.0%) but comparable in low-risk (22.6%) and intermediate-risk patients (28.7%) (hazard ratio [HR] for intermediate-risk versus low-risk, 1.03; 95% confidence interval [CI], 0.77 to 1.37; p = 0.85; HR for high-risk versus low-risk, 2.27; 95% CI 1.72 to 2.99; p = <0.001). Similarly, the cumulative 4-year cardiovascular mortality rates were higher in high-risk patients (20.5%) but comparable in low-risk (9.9%) and intermediate-risk patients (10.3%) (HR for intermediate-risk versus low-risk, 1.10; 95% CI, 0.68 to 1.77; p = 0.69; HR for high-risk versus low-risk, 2.33; 95% CI 1.48 to 3.67; p = <0.001). After adjustment for several confounders, STS score ≥8% was independently associated with increased long-term mortality (HR, 1.35; 95% CI, 1.08 to 1.68). In conclusion, the risk stratification according to STS score demonstrated an increased risk of long-term mortality after TAVI in high-risk patients, albeit with comparable risks in intermediate- and low-risk patients.

Electrocardiogram (ECG) left ventricular hypertrophy (LVH) is associated with the prognosis of patients with aortic stenosis. However, the impact of the presence or absence of ECG-LVH on the clinical outcomes after transcatheter aortic valve implantation (TAVI) is limited. This study aimed to assess the prognostic value of ECG-LVH among patients with aortic stenosis treated by TAVI. A total of 1,667 patients who underwent TAVI were prospectively enrolled into the OCEAN-TAVI (Optimized CathEter vAlvular iNtervention—Transcatheter Aortic Valve Implantation) registry. A total of 1,446 patients (mean age 84 years; 29.9% men) were analyzed. The Sokolow–Lyon index was used to determine the presence of ECG-LVH. LVH was also assessed using transthoracic echocardiography (TTE). We investigated the association between ECG-LVH and all-cause and cardiovascular mortality. This study identified ECG-LVH and TTE-LVH in 743 (51.5%) and 1,242 patients (86.0%), respectively. The Kaplan–Meier analysis revealed that all-cause mortality was significantly higher among patients without ECG-LVH than among those with ECG-LVH (log-rank p <0.001). In the multivariable analysis, the absence of ECG-LVH was independently associated with all-cause mortality (hazard ratio 1.98, 95% confidence interval 1.39 to 2.82, p <0.001), regardless of the presence or absence of TTE-LVH. Furthermore, the presence of TTE-LVH with the absence of ECG-LVH was observed in 575 patients (40%), which was associated with cardiovascular mortality (hazard ratio 2.84, 95% confidence interval 1.56 to 5.17, p <0.001). In conclusion, the absence of ECG-LVH was independently associated with an increased risk of all-cause mortality after TAVI. Risk stratification using both ECG-LVH and TTE-LVH is a useful predictor of adverse clinical outcomes after TAVI.

•Subclinical hemolysis after TAVI has occasionally been documented.•Decompensated hemolytic anemia requiring specific treatment has been rare.•The incidence of hemolytic anemia after TAVI using S3UR was not negligible.•PVL ≥ mild was associated with an increased risk of hemolytic anemia. Decompensated hemolytic anemia after transcatheter aortic valve implantation (TAVI) requiring specific treatment is rarely encountered in actual clinical practice. Nevertheless, there have been several cases of clinically relevant hemolytic anemia following implantation of the recently launched SAPIEN 3 Ultra RESILIA (S3UR). This study aimed to elucidate the clinical features of hemolytic anemia following S3UR implantation. Patients who underwent TAVI using S3UR from the end of March 2023 to November 2023 were enrolled from the Japanese multicenter OCEAN (Optimized CathEter vAlvular iNtervention)–TAVI registry. Hemolytic anemia was defined as (1) a drop in hemoglobin level by >2.0 g/dL within 3 months after the index TAVI procedure and (2) the diagnosis of mechanical hemolysis as the cause of anemia made by the attending physician and hematologist based on the presence of any 2 of the following criteria: (1) serum lactate dehydrogenase level >220 IU/L; (2) haptoglobin level <0.5 g/L; and (3) reticulocyte count ≥2%. Of the 1,070 patients, 18 (1.7%) patients developed hemolytic anemia after TAVI. These patients had a significantly lower prosthesis oversizing relative to native annulus (−3.7% [−5.9% to 0.1%] vs 7.5% [0.6% to 14.0%], p <0.001) and a higher prevalence of paravalvular leakage (PVL) ≥mild (mild PVL: 61.1% vs 12.4%; moderate-to-severe PVL: 16.7% vs 0.2%; p <0.001) than those without hemolytic anemia. PVL ≥mild was associated with a higher incidence of hemolytic anemia particularly in patients with oversizing of <−5% (33.3% vs 1.3%, p <0.001) and in those with −5%≤ oversizing <10% (8.3% vs 0.7%, p <0.001). In conclusion, the incidence of decompensated hemolytic anemia after S3UR implantation was not negligible, and the results of the present study support the importance of selecting a prosthesis size with a sufficient oversizing relative to native annulus to minimize residual PVL ≥mild leading to hemolytic anemia after TAVI. [Display omitted]

•Moderate/severe and mild thrombocytopenia at baseline had significantly higher risk for late-bleeding after TAVR.•Moderate/severe thrombocytopenia had significantly higher risk for all-cause and noncardiovascular death after TAVR.•In patients with thrombocytopenia, the choosing the antithrombotic therapy and its intensity should be adjusted appropriately. [Display omitted] Baseline thrombocytopenia was reported as a risk factor for bleeding or mortality in several medical areas, particularly in the cardiovascular field. This study aimed to assess the prognostic value of baseline thrombocytopenia in patients who had transcatheter aortic valve implantation. This study included 2,588 patients from the Optimized Catheter valvular intervention Japanese multicenter registry. Thrombocytopenia was defined as platelet count of <150 × 109/L and was classified into moderate/severe (<100 × 109/L) and mild (≧100-<150 × 109/L). At 3 years after index procedure, the moderate/severe thrombocytopenia group had a significantly higher cumulative composite late bleeding than the no thrombocytopenia group (log-rank test, p < 0.0001). Moreover, the moderate/severe thrombocytopenia group had a significantly higher cumulative all-cause, cardiovascular, and noncardiovascular mortality rates than the no thrombocytopenia group (log-rank test, p < 0.0001, p = 0.0014, p < 0.0001, respectively). After adjusting for confounders, the excess risk of moderate/severe and mild thrombocytopenia relative to no thrombocytopenia for the composite bleeding remained significant (hazard ratio 2.66: [95% confidence interval: 1.35 to 4.88], p = 0.006 and hazard ratio 2.10: [95% confidence interval: 1.36 to 3.21], p = 0.001, respectively). In conclusion, baseline thrombocytopenia was associated with an increased risk of late bleeding and poor prognosis. Baseline platelet level could be a prognostic marker for risk stratification.

The influence of polyvascular disease (PVD) on the short- and long-term clinical outcomes of patients undergoing transcatheter aortic valve implantation via trans-femoral access (TF-TAVI) has not been fully elucidated. A total of 2167 patients from the Optimized CathEter vAlvular iNtervention-TAVI (OCEAN-TAVI) registry who underwent TF-TAVI was studied. PVD was defined as the presence of at least two of the following vascular bed (VB) diseases: concomitant coronary artery disease (CAD), cerebrovascular disease (CVD), and peripheral artery disease (PAD). Patients with PVD (288 patients, 13.3%) had a higher incidence of in-hospital complications, such as AKI (16.3% vs. 7.0%, p<0.01) and disabling stroke (3.5% vs. 1.2%, p<0.01) than patients without PVD. These complications caused higher rates of procedural mortality (4.5% vs. 2.0%, p<0.01). PVD increased the risk of the 2-year rate of cardiovascular death (adjusted hazard ratio [HR], 1.61; 95% confidence interval [CI], 1.04-2.50; p<0.05); however, non-cardiovascular death, myocardial infarction, or ischemic stroke was not associated with PVD. Worsening heart failure (4.6% vs. 1.1%, p<0.01) was the main cause of cardiovascular death among patients with PVD. In a sub-analysis, compared with patients with AS alone, those with 2 VB diseases (CAD+PAD; adjusted HR, 1.93; 95% CI, 1.06-3.53; p<0.05) and 3 VB diseases (CAD+CVD+PAD; adjusted HR, 2.61; 95% CI, 1.21-5.62; p<0.05) had a higher risk of 2-year cardiovascular death. The increased prevalence of concomitant atherosclerotic VB diseases before TF-TAVI may increase the rates of in-hospital complications and 2-year cardiovascular death. Given the higher rate of mortality in patients with PVD undergoing TF-TAVI, future studies focusing on medical therapy are needed to reduce long-term cardiovascular events in this high-risk subset.

No data are available on extended dual anti-platelet therapy (DAPT) duration which may influence long-term prognosis (later than 1 year) after transcatheter aortic valve replacement (TAVR). Therefore, this study is aimed to evaluate whether discontinuing DAPT within 1 year had an impact on adverse events after TAVR. Using data from the OCEAN-TAVI registry, we assessed 1008 patients who survived the first year after TAVR with DAPT since discharge. Patients were divided into ‘DAPT group’ ( n  = 462), comprising patients who took DAPT at both discharge and 1 year, and ‘stop-DAPT group’ ( n  = 546), comprising patients who took DAPT at discharge and single anti-platelet therapy (SAPT) at 1 year. We compared the incidence of cardiovascular (CV) death, major and minor bleeding, and ischemic stroke later than 1 year after TAVR between the two groups. A total of 28 CV deaths were observed later than 1 year after TAVR. The stop-DAPT group had a significantly lower incidence of CV death than the DAPT group (1.8% vs. 4.9%, log-rank P  = 0.029). Stop DAPT was associated with lower CV death later than 1 year of TAVR in Cox regression analysis (adjusted hazard ratio [HR], 0.46; 95% confidence interval [CI], 0.20–0.99), and in analysis with inverse probability of treatment weighting method using propensity score (adjusted HR, 0.45; 95% CI, 0.20–0.98). Our study demonstrated that switching from DAPT to SAPT within 1 year of TAVR was significantly associated with a lower CV death later than 1 year after TAVR.

Frailty is strongly associated with poor short- and long-term prognoses in patients who undergo transcatheter aortic valve implantation (TAVI). However, limited data are available regarding the association between frailty and late bleeding events after TAVI. Of the 2,518 patients in the Japanese multicenter TAVI registry, 1371 patients with complete data on frailty parameters were analyzed. We developed a modified Essential Frailty Toolset (EFT) using 4 frailty parameters—gait speed, Mini-Mental State Examination (MMSE), anemia, and hypoalbuminemia—that are significant predictors of late bleeding events in this cohort. The predictive value of the modified EFT for late bleeding after TAVI was assessed in comparison with other clinical variables. Late bleeding events after TAVI occurred in 80 patients (5.8%). Gait speed, MMSE, anemia, and hypoalbuminemia were significantly associated with late bleeding. A modified EFT was developed to include these parameters, which were scored from 0 to 5 points comprising the following 4 items: gait speed (0: >1.5 m/s, 1: 1.5 to 0.75 m/s, 2: <0.75 m/s), cognition (1: MMSE <18), anemia (1: hemoglobin <13 g/100 ml in men or <12 g/100 ml in women), and malnutrition (1: albumin <3.5 g/100 ml). Multivariate Cox regression analysis revealed that the modified EFT was an independent predictor of late bleeding (adjusted hazard ratio 1.51, 95% confidence interval [CI] 1.19 to 1.92, p <0.001) In conclusion, the modified EFT was found to be a significant predictive factor for late bleeding events after TAVI. Assessment of frailty is important to predict patients with high bleeding risk after TAVI.

Cognitive impairment is common in patients underwent transcatheter aortic valve implantation (TAVI) and might affect procedure outcomes. This study evaluated the incidence of preprocedural cognitive impairment and its impact on clinical outcomes after TAVI. We analyzed the data of 1,111 patients (age ≥70 years) obtained from the Optimized CathEter vAlvular iNtervention (OCEAN-TAVI) registry. The cognitive performance of all patients was assessed using the Mini-Mental State Examination (MMSE) at baseline. We evaluated the 1-year cumulative mortality after TAVI according to the MMSE performance. Cognitive impairment was present in 420 (38%) of 1,111 patients. Compared with patients with normal cognition, those with cognitive impairment showed higher cumulative all-cause and noncardiovascular mortality rates at 1 year (14% vs. 8%, p = 0.001; 11% vs. 5%, p <0.001, respectively). Moreover, cognitive impairment increased the risk of mortality from sepsis (2% vs. 0.4%; hazard ratio, 4.2; 95% confidence interval, 1.3 to 13.5; p = 0.02). In adjusted models, cognitive impairment was an independent risk factor for 1-year all-cause mortality (adjusted hazard ratio, 2.1; 95% confidence interval, 1.1 to 4.0; p = 0.02). Although patients with cognitive impairment had more in-hospital adverse outcomes, including prolonged hospital stays, major bleeding and vascular complications, and acute kidney injury, than did those with normal cognition, the 30-day mortality was similar between the groups (1% in the two groups; p >0.99). In conclusion, cognitive impairment based on the MMSE score was an independent predictor of mortality at 1 year after TAVI.

Data regarding the longitudinal effect of catheter procedure-related acute kidney injury (AKI) on clinical outcomes are limited. This study aimed to assess the late adverse cardiorenal events of AKI following transcatheter aortic valve implantation (TAVI). A total of 2,518 patients who underwent TAVI, excluding in-hospital deaths, were enrolled from the Japanese multicenter registry. The definition of AKI was determined using the Valve Academic Research Consortium-2 criteria. The incidence, predictors, major adverse renal and cardiac events (MARCE), and all-cause mortality of AKI were evaluated. MARCE included readmission for renal and heart failure (HF), hemodialysis requirement, and cardiovascular-renal death during the follow-up period. The incidence of AKI was 9.7% in the entire cohort. The significant predictive factors of AKI were men, diabetes mellitus, hypertension, chronic kidney disease, low albumin, overdose of contrast media, nontransfemoral approach, transfusion, vascular complications, and new pacemaker implantation. The rates of HF readmission and future hemodialysis were significantly higher in patients with AKI than in those without AKI (19.7% vs 9.0%, p <0.001, 3.3% vs 0.4%, p <0.001, respectively). Cox regression multivariate analysis showed that AKI occurrence was an independent predictive factor for the incremental risk of both MARCE and late mortality up to 4 years (hazard ratio [HR] 1.59, 95% confidence interval [CI] 0.75 to 1.20, p <0.001, HR 2.18, 95% CI 1.70 to 2.79; p <0.001, respectively). In conclusion, AKI occurrence was significantly associated with late adverse cardiorenal events after TAVI. Adequate clinical management can be expected to reduce AKI-related late phase cardiorenal damage even after successful TAVI.