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BACKGROUND The impact of balloon post-dilatation (BPD) on short- and long-term valve performance after Sapien 3 (S3) implantation is unknown. This study aimed to evaluate the impact of balloon post-dilatation (BPD) on short- and long-term valve performance after the implantation of S3. METHODS A total of 846 patients implanted with S3 from the OCEAN-TAVI registry were included in this study. The patients were divided into BPD and non-BPD groups. The clinical outcomes and valve functions were compared. RESULTS The BPD group included 173 (20.4%) patients and the non-BPD group comprised 673 (79.6%) patients. The prosthesis-patient mismatch (PPM) rates were significantly lower in the BPD group than in the non-BPD group before and after propensity score matching at in-hospital follow-up (before matching: 12 [7.1%] vs. 108 [16.3%], p = 0.002; after matching: 8 [6.3%] vs. 19 [14.8%], p = 0.027) and at 1-year follow-up (before matching: 14 [12.5%] vs. 112 [23.6%], p = 0.010; after matching: 9 [10.5%] vs. 19 [22.1%], p = 0.039). The rates of acute kidney injury, cardiac tamponade, and in-hospital cardiovascular death were significantly higher in the BPD group than in the non-BPD group (acute kidney injury: 22 [12.7%] vs. 33 [4.9%], p < 0.001; cardiac tamponade: 3 [1.7%] vs. 2 [0.3%], p = 0.028; in-hospital cardiovascular death: 4 [2.3%] vs. 3 [0.4%], p = 0.016). After matching, these clinical outcomes were similar between the BPD and non-BPD groups. CONCLUSIONS The BPD group demonstrated better short- and long-term valve performance. Caution is needed to avoid procedure-related complications in patients undergoing BPD.

BACKGROUND The role of direct oral anticoagulants as compared with vitamin K antagonists for atrial fibrillation after successful transcatheter aortic-valve replacement (TAVR) has not been well studied. METHODS We conducted a multicenter, prospective, randomized, open-label, adjudicator-masked trial comparing edoxaban with vitamin K antagonists in patients with prevalent or incident atrial fibrillation as the indication for oral anticoagulation after successful TAVR. The primary efficacy outcome was a composite of adverse events consisting of death from any cause, myocardial infarction, ischemic stroke, systemic thromboembolism, valve thrombosis, or major bleeding. The primary safety outcome was major bleeding. On the basis of a hierarchical testing plan, the primary efficacy and safety outcomes were tested sequentially for noninferiority, with noninferiority of edoxaban established if the upper boundary of the 95% confidence interval for the hazard ratio did not exceed 1.38. Superiority testing of edoxaban for efficacy would follow if noninferiority and superiority were established for major bleeding. RESULTS A total of 1426 patients were enrolled (713 in each group). The mean age of the patients was 82.1 years, and 47.5% of the patients were women. Almost all the patients had atrial fibrillation before TAVR. The rate of the composite primary efficacy outcome was 17.3 per 100 person-years in the edoxaban group and 16.5 per 100 person-years in the vitamin K antagonist group (hazard ratio, 1.05; 95% confidence interval [CI], 0.85 to 1.31; P���=���0.01 for noninferiority). Rates of major bleeding were 9.7 per 100 person-years and 7.0 per 100 person-years, respectively (hazard ratio, 1.40; 95% CI, 1.03 to 1.91; P���=���0.93 for noninferiority); the difference between groups was mainly due to more gastrointestinal bleeding with edoxaban. Rates of death from any cause or stroke were 10.0 per 100 person-years in the edoxaban group and 11.7 per 100 person-years in the vitamin K antagonist group (hazard ratio, 0.85; 95% CI, 0.66 to 1.11). CONCLUSIONS In patients with mainly prevalent atrial fibrillation who underwent successful TAVR, edoxaban was noninferior to vitamin K antagonists as determined by a hazard ratio margin of 38% for a composite primary outcome of adverse clinical events. The incidence of major bleeding was higher with edoxaban than with vitamin K antagonists. (Funded by Daiichi Sankyo; ENVISAGE-TAVI AF ClinicalTrials.gov number, NCT02943785.).

Background Dialysis patients with aortic stenosis are generally considered as being at extreme or high surgical risk. Herein, the first clinical trial was conducted to investigate clinical safety and effectiveness of transcatheter aortic valve replacement (TAVR) using the balloon-expandable transcatheter aortic valve (SAPIEN 3, Edwards Lifesciences, Irvine, CA, USA) in Japanese dialysis patients. Methods The clinical trial is a single arm, prospective, open, non-randomized, Japanese multicenter study. The primary purpose of this trial is to evaluate the efficacy and safety of TAVR using SAPIEN 3 in 28 Japanese dialysis patients. Results Mean age was 79.2 years and 67.9% were male (Mean STS score was 14.3%). Transfemoral and transapical approaches were performed in 25 (89.3%) and 3 patients (10.7%), respectively. All bioprostheses were successfully implanted. Median intensive care unit stay and hospital stay after TAVR were 1.4 days and 6.3 days, respectively. In-hospital mortality was 3.6% and freedom from all-cause mortality at 1 year was 89.3%. Disabling stroke and life-threatening bleeding at 1 year was 7.7% and 8.5%, respectively. There was no structural valve deterioration during follow-up. New York Heart Association functional status, six-minute walk test, and EuroQOL visual analogue scale score significantly improved through 1 year compared with baseline. Conclusions TAVR using SAPIEN 3 is safe and effective for the treatment of Japanese dialysis patients with symptomatic severe aortic valve stenosis.

Sleep disorders and sleep duration have attracted considerable attention as potential modifiable risk factors for the development and progression of heart failure (HF). However, whether these sleep behaviors could aggravate the underlying cardiac condition remains ambiguous. We evaluated the associations between the levels of plasma B-type natriuretic peptide (BNP) and sleep-disordered breathing (SDB), sleep quality and quantity, or daytime sleepiness in cardiovascular diseases (CVD) patients. A total of 1717 consecutive patients with CVD [median age, 66 years (55–74 years); female, 27.5%] were enrolled. SDB was screened by nocturnal pulse oximetry; sleep quality and quantity were determined by Pittsburg Sleep Quality Index, and daytime sleepiness was examined by Epworth Sleepiness Scale. The median plasma BNP level was 54.9 pg/ml (23.5–146.4 pg/ml). Multiple regression analyses showed that the BNP level in the highest quintile (BNP > 181.8 pg/ml) was associated with SDB (severe: OR, 5.88; 95% CI 3.17–10.88; moderate: OR, 3.62; 95% CI 2.17–6.02; mild: OR, 2.22: 95% CI 1.42–3.47). There were no significant associations between other sleep parameters and higher BNP levels. The relationship between SDB and BNP levels was unchanged regardless of the previous history of symptomatic HF. SDB was independently associated with the elevated plasma BNP level in patients with a variety of CVD.

BACKGROUND The effect of sex on mortality is controversial; furthermore, sex differences in left ventricular (LV) remodeling after transcatheter aortic valve implantation (TAVI) remain unknown.Methods and Results:This study included 2,588 patients (1,793 [69.3%] female) enrolled in the Optimized CathEter vAlvular iNtervention (OCEAN)-TAVI Japanese multicenter registry between October 2013 and May 2017. We retrospectively analyzed the effect of sex on mortality, and evaluated changes in the LV mass index (LVMI) after TAVI. Female sex was significantly associated with lower all-cause and cardiovascular mortality (log-rank P

Background The REPRISE Japan study, a prospective multicenter single-arm trial, was undertaken to confirm the safety and effectiveness of transcatheter aortic valve replacement (TAVR) with the LOTUS valve in Japanese subjects with severe symptomatic calcific aortic stenosis at extreme or high surgical risk.Methods and Results:REPRISE Japan enrolled 40 subjects in the transfemoral (TF) cohort (mean age 84 years; mean [±SD] Society of Thoracic Surgeons [STS] score 6.4±2.9%); 10 additional subjects were treated with a transaortic (TAo) approach (mean age 84 years; mean STS score 6.3±3.3%). A subanalysis was also performed on subjects treated with the 21-mm LOTUS valve (n=15; mean age 84 years; mean STS score 5.3±2.1%). The primary safety endpoint (a composite of all-cause mortality, stroke, life-threatening or major bleeding events, acute kidney injury [Stage 2/3], and major vascular complications at 30 days) occurred in 15% of TF subjects. The primary effectiveness endpoint (a composite of all-cause mortality, disabling stroke, and moderate or greater paravalvular leak [PVL; core laboratory assessed] at 6 months) occurred in 5.3% of TF subjects. Across the TF, TAo, and 21-mm LOTUS valve cohorts, no subjects exhibited moderate or greater PVL at 6 months. The 30-day rate of pacemaker implantation was 22.5% in the TF cohort (TAo: 20%; 21 mm: 13.3%). Conclusions Data from REPRISE Japan confirm the safety and efficacy of the LOTUS Valve when used in Japanese clinical practice.

Atherosclerosis is a risk factor for both aortic stenosis (AS) and coronary artery disease. This study aimed to investigate whether anti-atherosclerotic therapy (AT), defined as the simultaneous use of antiplatelet agents, statins, and renin aldosterone system inhibitors, had long-term clinical benefits for patients who underwent transcatheter aortic valve replacement (TAVR). Between October 2013 and May 2017, 2518 patients (31% men; median age, 85 years) who underwent TAVR in 14 Japanese centers were divided into two groups: patients who were prescribed anti-atherosclerotic therapy (AT, n = 567) and patients who were not (no AT, n = 1951). The median follow-up period for this cohort was 693 days (interquartile range, 389-870 days). Compared to no AT group, AT group was associated with significantly lower 2-year all-cause mortality (11.7% vs. 16.5%; log-rank p = 0.002) and 2-year cardiovascular mortality rates (3.5% vs. 6.0%; log-rank p = 0.017). In a propensity-matched cohort (n = 495 each; median follow-up, 710 days [IQR, 394 - 896 days]), patients in AT group had a lower prevalence of 2-year cardiovascular mortality (3.8% vs. 6.2%, log-rank p = 0.024) than that in the no AT group. In the multivariate stepwise regression analysis, AT was a significant predictor of cardiovascular mortality (hazard ratio 0.45; 95% confidence interval 0.25-0.80; p = 0.007). AT may improve survival in post-TAVR patients. Future studies are necessary to identify an optimal treatment regimen to improve long-term outcomes after TAVR.

Severe aortic stenosis (AS) is often accompanied by renal dysfunction, which portends a poor prognosis. Trans-catheter aortic valve replacement (TAVR) is an accepted therapy for patients with severe AS, whereas the prediction of persistent renal dysfunction following TAVR remains challenging. In this study, we aimed to evaluate the pre-procedural score to assess the reversibility of renal dysfunction following TAVR. A total of 2,588 patients with severe AS who received TAVR and were enrolled in the Optimized transCathEter vAlvular iNtervention (OCEAN-TAVI) multicenter registry (UMIN000020423) were retrospectively investigated and those with serum creatinine (Cre) data at baseline and one year following TAVR were included. The Cre score was calculated using the formula: 0.2 × (age [years]) + 3.6 × (baseline serum Cre [mg/dL]). This score was evaluated to assess the risk of persistent renal dysfunction defined as serum Cre level > 1.5 mg/dL at one year following TAVR. Of the 1705 patients (84.3 ± 5.0 years old) included, 246 (14%) had persistent renal dysfunction following TAVR. The Cre score predicted the incidence of persistent renal dysfunction with an adjusted incidence rate ratio of 1.48 (95% confidence interval 1.42-1.56) with a cutoff of 21.4 (43% versus 5%, P < 0.001). The Cre score also predicted 4-year survival following TAVR (70% versus 52%, P < 0.001) with an adjusted hazard ratio of 1.75 (95% confidence interval 1.29-2.37). In conclusion, the Cre score identified those with a high risk of one-year persistent renal dysfunction following TAVR. The implication of Cre score-guided therapeutic strategy is the next concern.

Background: Patients with anemia have a poor prognosis following transcatheter aortic valve implantation (TAVI). Given the unique distribution of hemoglobin levels in the Japanese cohort, the optimal cut-off hemoglobin value may help stratify Japanese patients’ mortality following TAVI. Methods and Results: Data of patients who underwent TAVI were collected from the prospective multicenter Optimized transCathEter vAlvular iNtervention (OCEAN)-TAVI Registry. Receiver operating characteristic analysis was used to calculate a hemoglobin cut-off value to stratify 2-year mortality following TAVI. In all, 2,588 patients (mean [±SD] age 84.4±5.2 years, 795 men) were included in the study. Of these patients, 909 (35.1%) had anemia, which was defined as hemoglobin

Background: Adipose tissue (AT) characteristics are considered to be a marker for predicting clinical outcomes. This study aimed to investigate the prognostic value of subcutaneous adipose tissue (SAT) and visceral adipose tissue (VAT) computed tomography (CT) assessment in patients who underwent transcatheter aortic valve replacement (TAVR). Methods: We used the Japanese multicentre registry data of 1372 patients (age: 84.5 ± 5.0 years, women: 70.6%) who underwent TAVR. The SAT and VAT were assessed according to the preprocedural CT area and density. Baseline characteristics and clinical outcomes were compared based on the differences in AT characteristics. The independent associations with all-cause mortality after TAVR were evaluated according to the CT area and density of AT. Results: Low-volume area of SAT and VAT was associated with worse clinical outcomes compared with high-volume area of SAT and VAT in patients who underwent TAVR (log-rank test P = 0.016 and P = 0.014). High CT density of SAT and VAT was associated with increasing mortality in comparison with low CT density of SAT and VAT (log-rank test P < 0.001 and P = 0.007). The Cox regression multivariate analysis demonstrated the independent association of increased all-cause mortality in the high SAT and VAT density (hazard ratio [HR]: 1.41, 95% confidence interval [CI]: 1.06-1.88, P = 0.019, and HR: 1.34, 95% CI: 1.03-1.76, P = 0.031, respectively), but not in the low SAT and VAT area (HR: 0.85, 95% CI: 0.74-1.29, P = 0.85, and HR: 0.78, 95% CI: 0.60-1.03, P = 0.085, respectively). Conclusions: CT-derived AT characteristics, particularly the qualitative assessments, were useful for predicting the prognosis in patients after TAVR. Résumé: Introduction: Les caractéristiques du tissu adipeux (TA) sont considérées comme un marqueur de la prédiction des résultats cliniques. La présente étude avait pour objectif d’examiner la valeur pronostique de l’évaluation par tomodensitométrie (TDM) du tissu adipeux sous-cutané (TASC) et du tissu adipeux viscéral (TAV) des patients qui subissaient un remplacement valvulaire aortique par cathéter (RVAC). Méthodes: Nous avons utilisé les données du registre multicentrique japonais de 1 372 patients (âge : 84,5 ± 5,0 ans, femmes : 70,6 %) qui subissaient un RVAC. Nous avons évalué le TASC et le TAV selon la surface et la densité à la TDM préinterventionnelle. Nous avons comparé les caractéristiques initiales et les résultats cliniques en nous basant sur les différences dans les caractéristiques du TA. Nous avons évalué les associations indépendantes à la mortalité toutes causes confondues après le RVAC selon la surface et la densité du TA à la TDM. Résultats: La surface de faible volume du TASC et du TAV était associée à de plus mauvais résultats cliniques que la surface de grand volume du TASC et du TAV chez les patients qui subissaient le RVAC (test logarithmique par rangs P = 0,016 et P = 0,014). La densité du TASC et du TAV à la TDM était associée à l’augmentation de la mortalité en comparaison d’une faible densité du TASC et du TAV à la TDM (test logarithmique par rangs P < 0,001 et P = 0,007). L’analyse multivariée selon le modèle de régression de Cox démontrait l’association indépendante de l’augmentation de la mortalité toutes causes confondues lors de densité élevée du TASC et du TAV (rapport de risque [RR] 1,41, intervalle de confiance [IC] à 95 %, 1,06-1,88, P = 0,019, et RR 1,34, IC à 95 %, 1,03-1,76, P = 0,031, respectivement), mais non lors de faible surface du TASC et du TAV (RR 0,85, IC à 95 %, 0,74-1,29, P = 0,85, et RR 0,78, IC à 95 % : 0,60-1,03, P = 0,085, respectivement). Conclusions: Les caractéristiques du TA acquises par TDM, particulièrement les évaluations qualitatives, étaient utiles à la prédiction du pronostic des patients après le RVAC.

BACKGROUND Little is known about changes in nutritional status as an index of frailty on clinical outcomes after transcatheter aortic valve replacement (TAVR). This study aimed to assess the clinical impact of serum albumin changes after TAVR. METHODS Changes in serum albumin levels from baseline to 1 year after TAVR were evaluated in 1524 patients who were classified as having hypoalbuminemia (

Heart failure (HF) is a risk factor for adverse post-procedural outcome after revascularization; however, it is unclear how left ventricular systolic dysfunction (LVSD) and clinical HF symptoms affect percutaneous coronary intervention (PCI) outcomes. We investigated the characteristics and long-term outcomes of patients with clinical HF or LVSD after PCI.This was a Japanese multicenter registry study of adult patients receiving PCI. Among 4689 consecutive patients who underwent PCI at 15 hospitals from January 2009 to December 2012, we analyzed 2634 (56.2%) with documented left ventricular ejection fraction (LVEF). They were divided into four groups based on clinical HF (symptoms or HF hospitalization) and LVEF [≥35% and35% (HF due to LVSD)]. The primary outcome was major adverse cardiovascular events (MACE), comprising all-cause death, acute coronary syndrome, HF hospitalization, performance of coronary artery bypass grafting, and stroke within 2 years after the initial PCI.Our findings revealed 354 patients (13.4%) with HF (clinical HF, n = 173, 48.9%; LVSD, n = 132, 37.3%; both, n = 49; 13.8%). The incidence of MACE was higher in patients with clinical HF or LVSD, and was largely due to higher non-cardiac death and HF hospitalization. After adjustment, clinical HF (hazard ratio 2.16, 95% confidence interval; 1.49-3.14) and lower LVEF (per 10%, hazard ratio 0.89, 95% confidence interval; 0.81-0.99) were independently associated with higher MACE risk.Clinical HF and LVSD were independently associated with adverse long-term clinical outcomes, particularly with non-cardiac death and HF readmission, in patients treated with PCI.

Background Transcatheter aortic valve implantation (TAVI) has become the main treatment for symptomatic severe aortic stenosis, but patients on dialysis have been excluded from major randomized controlled trials. Our aim was to compare mortality and procedure-related complications after TAVI in patients with end-stage renal disease (ESRD) on dialysis vs those without. Methods EMBASE and MEDLINE were searched through November 2019 to investigate the comparative outcomes between patients with ESRD on dialysis and those without who underwent TAVI. The main outcomes were short-term (30-day/in-hospital) mortality and procedural complications, and long-term (>6 months) all-cause mortality. Results Our search identified 10 observational studies enrolling 128,094 (5399 on dialysis) patients who underwent TAVI. Dialysis patients had a significantly higher rate of short-term and long-term mortality than nondialysis patients (odds ratio [95% confidential interval]: 2.18 [1.64-2.89], P Conclusion Dialysis patients had significantly higher rates of short- and long-term mortality, short-term life-threatening and/or major bleeding, permanent pacemaker implantation, and device failure compared with nondialysis patients. Careful selection of patients who would benefit from TAVI among patients with ESRD requiring dialysis is necessary to prevent high rates of postprocedural complications.

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.

Background Cerebrovascular events (CVEs) are not uncommon complications of transcatheter aortic valve replacement (TAVR). Our study aimed to determine the predictors of peri-procedural and sub-acute CVEs following TAVR. Methods Using the Japanese multicenter registry, we evaluated 1613 patients undergoing TAVR between October-2013 and July-2016. Occurrences of 24-hour and 1- to 30-day CVEs were evaluated to clarify the predictors of CVEs following TAVR. Results The mean age was 84.4 years and mean Society of Thoracic Surgeons score was 8.3%. Overall 24-hour and 30-day CVE rates were 1.2% and 2.7%, respectively. A multivariate analysis demonstrated that independent predictor of 24-hour CVEs was index aortic valve area (iAVA) [adjusted OR (adjusted-OR), 0.001; 95% CI, 0.001–0.13; p = .005]. The receiver operator curve derived cut-off value of iAVA for the prediction of 24-hour CVEs was 0.40 cm2/m2. In contrast, independent predictors of 1- to 30-day CVEs were paroxysmal atrial fibrillation (PAF; adjusted-OR, 3.35; 95% CI, 1.36–8.27; p = .009) and iAVA after TAVR (adjusted-OR, 0.11; 95% CI, 0.02–0.66; p = .02). Consequently, independent predictors of 30-day CVEs were prior stroke (adjusted-OR, 2.18; 95% CI, 1.07–4.45; p = .03), PAF (adjusted-OR, 2.18; 95% CI, 1.05–4.56; p = .04), and prior coronary artery disease (adjusted-OR, 1.88; 95% CI, 1.01–3.48; p = .05). Conclusions Within 24 h, small iAVA impacted the increased risk of CVEs, whereas PAF and iAVA after TAVR impacted the increased risk of 1- to 30-day CVEs following TAVR. The mechanism of CVEs might differ according to onset.

The optimal management of preexisting severe aortic stenosis (AS) in patients undergoing noncardiac surgery (non-CS) remains uncertain. This study aimed to investigate the safety and effectiveness of percutaneous aortic valve intervention (PAVI) in patients with AS before non-CS.We analyzed pooled data within a multicenter Japanese registry from 118 patients with severe AS who underwent PAVI before non-CS. Sixty patients underwent percutaneous balloon aortic valvuloplasty (BAV) and 58 patients underwent transcatheter aortic valve replacement (TAVR). The groups' baseline characteristics, perioperative complications, and 30-day mortality and midterm mortality after non-CS were compared.The postprocedural mean pressure gradient was higher in the BAV group than in the TAVR group (35.0 ± 11.5 mmHg vs. 11.5 ± 4.8 mmHg, p 0.001). The non-CS operation risk did not differ between the groups (p = 0.69). One patient in each group experienced a noncardiac death (p = 0.74), and the 30-day mortality rate after non-CS was 1.7%. Heart failure occurred in 2 patients in each group (p = 0.68). One patient in the TAVR group experienced a non-disabling stroke, and no myocardial infarctions occurred. Consequently, the combined adverse events were 5.0% and 6.9% in the 2 groups (p = 0.48). The bleeding rates during the non-CS were similar in both groups (33.3% vs. 25.9%, p = 0.25). There were no differences between the groups regarding midterm mortality (p = 0.60), whereas 53.3% of the patients in the BAV group required invasive treatment of their AS during follow-up.Among patients with severe AS, PAVI before non-CS reduces the AS severity and may contribute to procedural safety during non-CS.

OBJECTIVES: To identify the vulnerable diabetic cohort in patients undergoing transcatheter aortic valve replacement (TAVR). BACKGROUNDS: Considerable controversy remains about whether specific cohort exists in which presence of diabetes mellitus (DM) carries adverse risk of mortality after TAVR. METHODS: Of the 2588 patients who were enrolled in the OCEAN-TAVI registry, 2526 patients with glycohemoglobin data were analyzed. The individuals were divided into DM and non-DM groups according to previous medical history of DM or using diabetic medicine, and increased HbA1c values (≥6.5%) at baseline. The primary endpoint of this study was 2-year all-cause mortality after TAVR. RESULTS: The follow up rate of clinical outcome at 1-year was 2514/2526 (99.5%) and median follow-up period was 22.5 months. DM group had 699 (27.7%) patients, in which 153 (21.9%) was diagnosed by increased HbA1c levels without previous medical history of DM. Kaplan-Meier curve of 2-year all-cause mortality presented significant difference between patients with and without DM (p = 0.029). In addition, patients with low-density lipoprotein cholesterol (LDL-C) levels > 100 mg/dl and left ventricular ejection fraction (LVEF) < 40% had great risk of mortality after TAVR (LDL-C: hazard ratio [HR] 1.82, p < 0.001; LVEF: HR 2.61, p = 0.002, respectively). CONCLUSIONS: Presence of DM was significantly associated with poor outcome after TAVR and adverse effect of DM was remarkable in patients with relatively higher LDL-C levels and reduced LVEF under 40%. These subtypes may need intensive control of cardiovascular risk factors, including DM, before and after TAVR.

Background Ventricular‐arterial coupling predicts outcomes in patients with heart failure. The arterial elastance to end‐systolic elastance ratio (Ea/Ees) is a noninvasively assessed index that reflects ventricular‐arterial coupling. We aimed to determine the prognostic value of ventricular‐arterial coupling assessed through Ea/Ees after transcatheter aortic valve replacement to predict clinical events. Methods and Results We retrieved data on 1378 patients (70% women) who underwent transcatheter aortic valve replacement between October 2013 and May 2017 from the OCEAN‐TAVI (Optimized transCathEter vAlvular iNtervention) Japanese multicenter registry. We determined the association between Ea/Ees and the composite end point of hospitalization for heart failure and cardiovascular death by classifying the patients into quartiles based on Ea/Ees values (group 1: 0.666) during the midterm follow‐up after transcatheter aortic valve replacement. During a median follow‐up period of 736 days (interquartile range, 414–956), there were 247 (17.9%) all‐cause deaths, 89 (6.5%) cardiovascular deaths, 130 (9.4%) hospitalizations for heart failure, and 199 (14.4%) composite events of hospitalization for heart failure and cardiovascular death. The incidence of the composite end point was significantly higher in group 2 (hazard ratio [HR], 1.76; 95% CI, 1.08–2.87 [ P =0.024]), group 3 (HR, 2.43; 95% CI, 1.53–3.86 [ P P P =0.015]). Conclusions These findings suggest that a higher Ea/Ees at discharge after transcatheter aortic valve replacement is associated with adverse clinical outcomes during midterm follow‐up. Registration URL: https://www.upload.umin.ac.jp/ . Unique identifier: UMIN000020423.

The newly formed geometry between the native Valsalva and implanted transcatheter heart valve (THV) may induce local thrombogenicity. This study aimed to assess the incidence of and the clinical outcomes associated with Valsalva thrombus formation after transcatheter aortic valve implantation (TAVI).We retrospectively evaluated the multidetector computed tomography (MDCT) data of 338 patients following transcatheter aortic valve implantation (TAVI) using a balloon-expandable THV. The Valsalva and leaflet thrombi were assessed by MDCT at the left coronary cusp (LCC), right coronary cusp (RCC), and non-coronary cusp (NCC). Combined endpoints such as death, stroke, and readmission for heart failure rates in patients with and without Valsalva and/or leaflet thrombus were examined at two years. The overall incidence of Valsalva and leaflet thrombi was 8.9% and 8.3%, respectively. Significant differences in the location of the Valsalva thrombus in the LCC, RCC, and NCC were noted (5.0%, 4.2%, 8.9%, respectively, p0.001). The independent predictor for increased risk of Valsalva thrombus was high Valsalva area to implanted THV size ratio (odds ratio 11.8, 95% confidence interval [CI]: 1.67-83.0, p=0.013). Combined endpoints were similar in patients with and without Valsalva thrombus, Valsalva/leaflet thrombus, and leaflet thrombus (p0.05 for all).Valsalva thrombus was detected in 8.9% of patients following balloon-expandable THV implantation and was common in the LCC, but it did not increase the risk of adverse events after TAVI.

To determine the level of limitations in activities of daily living (ADL) and instrumental ADL, and identify related factors to instrumental ADL among elderly persons with severe aortic stenosis (AS). We prospectively enrolled 112 consecutive elderly persons (mean age, 84.6 ± 4.4 y) with severe AS. We assessed ADL and instrumental ADL using the Barthel index (BI) and the Frenchay activities index (FAI), respectively. Cardiac, physical, cognitive and kidney functions, nutritional status, medical histories, and comorbidities were assessed. A multiple logistic analysis was developed to explore related factors to the FAI. The medians (ranges) of BI and FAI were 100 (15–100) and 21 (0–38), respectively. The multiple logistic analysis revealed that a history of heart failure (sβ = −0.189), a history of cerebrovascular disease (sβ = −0.233), the short physical performance battery score ≤ 8 (sβ = −0.272), the mini-mental state examination score ≤ 23 (sβ = -0.168) were significantly related to the FAI (p Physical frailty, a history of heart failure, cerebrovascular disease, and cognitive decline were independently related to declined instrumental ADL.IMPLICATIONS FOR REHABILIATIONActivities of daily living was well-preserved among elderly persons with severe aortic stenosis.Instrumental activities of daily living varied among patients with aortic stenosis and was sometimes impaired.Physical frailty, a history of heart failure, and a history of cerebrovascular disease were independently associated with instrumental activities of daily living in elderly persons with severe aortic stenosis. Activities of daily living was well-preserved among elderly persons with severe aortic stenosis. Instrumental activities of daily living varied among patients with aortic stenosis and was sometimes impaired. Physical frailty, a history of heart failure, and a history of cerebrovascular disease were independently associated with instrumental activities of daily living in elderly persons with severe aortic stenosis.

Background: The prevalence, patient profile, and outcomes of sleep-disordered breathing (SDB) in aortic stenosis (AS) remain unknown, especially in East Asia. Methods and Results: One hundred and eighty-one AS patients undergoing transcatheter aortic valve implantation (TAVI) were enrolled. Sixty-one patients (33.7%) had SDB, and lower stroke volume index was an independent determinant of SDB. Incidence of in-hospital stroke after TAVI was higher in the SDB group. Conclusions: SDB is associated with left ventricular systolic dysfunction in Japanese AS patients referred for TAVI. SDB was highly associated with the incidence of stroke as a procedural complication.

BACKGROUND In the current guidelines, indications for transcatheter aortic valve implantation (TAVI) are expanded to include several subgroups of asymptomatic patients with severe aortic stenosis (AS), and there is a paucity of data on the prognostic impact of New York Heart Association (NYHA) functional class in patients with severe AS undergoing TAVI. METHODS Among 2588 patients enrolled in the OCEAN-TAVI registry, patients were divided into 4 groups according to baseline NYHA class (class I in 95 patients, class II in 1172 patients, class III in 1126 patients, and class IV in 195 patients). RESULTS Median follow-up was 729 days. The cumulative 2-year incidence of all-cause death was significantly higher in patients with NYHA class IV and III than in those with NYHA class II and I. (30.0%, 21.3%, 13.4%, and 11.2%, respectively, P < 0.001). After adjusting confounders, NYHA class IV and III, but not NYHA class II were independently associated with higher mortality compared with NYHA class I (reference) (adjusted HR: 3.43, 95%CI: 1.83-7.15, P < 0.001; adjusted HR: 2.07, 95%CI: 1.15-4.19, P = 0.013; and adjusted HR: 1.50, 95%CI: 0.83-3.04, P = 0.19, respectively). With increasing NYHA class, there was an incremental increase of heart failure hospitalization in the effect size relative to the reference (NYHA class I). CONCLUSIONS The long-term outcomes of patients with NYHA class I were better than those with NYHA class IV or III in some selected patients undergoing TAVI.

Aims To investigate the ability of the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria and ARC-HBR score to predict 2-year bleeding and mortality in patients undergoing transcatheter aortic valve replacement (TAVR). Methods and results We enrolled 2514 patients who underwent successful TAVR during 2013–17. In this study, we used the ARC-HBR score for further HBR-risk stratification, and the ARC-HBR score was calculated as follows: each major criterion was 2 points and each minor criterion was 1 point. The impact of the ARC-HBR criteria and increasing ARC-HBR score on the incidence of moderate/severe bleeding events, mortality, and ischaemic stroke in the first 2 years were evaluated. We used survival classification and regression tree (CART) analysis for 2-year moderate or severe bleeding events, and patients were statistically classified into HBR low- (ARC-HBR score ≤1), intermediate- (ARC-HBR score = 2–4), or high-risk (ARC-HBR score ≥5) groups, and 91.4% were at HBR (ARC-HBR score ≥2). The rates of 2-year moderate/severe bleeding events and all-cause mortality were higher in the ARC-HBR group and highest in the HBR high-risk group. An increased HBR score was significantly associated with moderate/severe bleeding events [hazard ratio (HR) 1.19, 95% confidence interval (CI) 1.07–1.31; P = 0.001] and all-cause mortality (adjusted HR 1.24, 95% CI 1.17–1.32; P < 0.001). Conclusions The ARC-HBR criteria identify patients at HBR after TAVR; an increased ARC-HBR score is associated with 2-year moderate/severe bleeding events and mortality.

ObjectiveTranscatheter aortic valve replacement (TAVR) improves clinical symptoms in most patients with severe aortic stenosis (AS). However, some patients do not benefit from the symptom-reducing effects of TAVR. We assessed the predictors and clinical outcomes of poor symptomatic improvement (SI) after TAVR.MethodsA total of 1749 patients with severe symptomatic AS undergoing transfemoral TAVR were evaluated using the Japanese multicentre TAVR registry. Poor SI was defined as readmission for heart failure (HF) within 1 year after TAVR or New York Heart Association (NYHA) class ≥3 after 1 year. A logistic regression model was used to identify predictors of poor SI. One-year landmark analysis after TAVR was used to evaluate the association between poor SI and clinical outcomes.ResultsAmong the overall population (mean age, 84.5 years; female, 71.3%; mean STS score, 6.3%), 6.6% were categorised as having poor SI. Atrial fibrillation, chronic obstructive pulmonary disease, Clinical Frailty Scale ≥4, chronic kidney disease and moderate to severe mitral regurgitation were independent predictors of poor SI. One-year landmark analysis demonstrated that poor SI had a higher incidence of all-cause death and readmission for HF compared with SI (pConclusionsPoor SI was associated with worse outcomes 1 year after the procedure. It had a greater impact on clinical outcomes than baseline symptoms. TAVR may be challenging for patients with many predictors of poor SI.Trial registration numberThis registry, associated with the University Hospital Medical Information Network Clinical Trials Registry, was accepted by the International Committee of Medical Journal Editors (UMIN-ID: 000020423).

Transcatheter mitral valve repair with the MitraClip, a catheter-based percutaneous edge-to-edge repair technique to correct mitral regurgitation (MR), has been demonstrated in Western studies to be an effective and safe MR treatment strategy. However, randomised clinical trial data on its use in Asian-Pacific patients is limited. Hence, the Asian Pacific Society of Cardiology convened an expert panel to review the available literature on MitraClip and to develop consensus recommendations to guide clinicians in the region. The panel developed statements on the use of MitraClip for the management of degenerative MR, functional MR, and other less common indications, such as acute MR, dynamic MR, hypertrophic obstructive cardiomyopathy, and MR after failed surgical repair. Each statement was voted on by each panel member and consensus was reached when 80% of experts voted ‘agree’ or ‘neutral’. This consensus-building process resulted in 10 consensus recommendations to guide general cardiologists in the evaluation and management of patients in whom MitraClip treatment is being contemplated.

ObjectiveData on statin for patients with aortic stenosis (AS) who underwent transcatheter aortic valve implantation (TAVI) are limited. The present study aimed to evaluate the impact of statin on midterm mortality of TAVI patients.DesignObservational study.SettingThis study included patients with AS from a Japanese multicentre registry who underwent TAVI.ParticipantsThe overall cohort included 2588 patients (84.4±5.2 years); majority were women (69.3%). The Society of Thoracic Surgeons risk score was 6.55% (IQR 4.55%–9.50%), the Euro II score was 3.74% (IQR 2.34%–6.02%) and the Clinical Frailty Scale score was 3.9±1.2.InterventionsWe classified patients based on statin at admission and identified 936 matched pairs after propensity score matching.Primary and secondary outcome measuresThe outcomes were all-cause and cardiovascular mortality.ResultsThe median follow-up was 660 days. Statin at admission was associated with a significant reduction in all-cause mortality (adjusted HR (aHR) 0.76, 95% CI 0.58 to 0.99, p=0.04) and cardiovascular mortality (aHR 0.64, 95% CI 0.42 to 0.97, p=0.04). In the octogenarians, statin was associated with significantly lower all-cause mortality (aHR 0.87, 95% CI 0.75 to 0.99, p=0.04); however, the impact in the nonagenarians appeared to be lower (aHR 0.84, 95% CI 0.62 to 1.13, p=0.25). Comparing four groups according to previous coronary artery disease (CAD) and statin, there was a significant difference in all-cause mortality, and patients who did not receive statin despite previous CAD showed the worst prognosis (aHR 1.33, 95% CI 1.12 to 1.57 (patients who received statin without previous CAD as a reference), pConclusionsStatin for TAVI patients will be beneficial even in octogenarians, but the benefits may disappear in nonagenarians. In addition, statin will be essential for TAVI patients with CAD. Further research is warranted to confirm and generalise our findings since this study has the inherent limitations of an observational study and included only Japanese patients.Trial registration numberUMIN000020423.

ObjectivesTranscatheter aortic valve replacement (TAVR) is increasingly performed. Physically small Asians have smaller aortic root and peripheral vessel anatomy. The influence of gender of Asian patients undergoing TAVR is unknown and may affect outcomes. The aim of this study was to assess sex differences in Asian patients undergoing TAVR.MethodsPatients undergoing TAVR from eight countries were enrolled. In this retrospective analysis, we examined differences in characteristics, 30-day clinical outcomes and 1-year survival between female and male Asian patients.ResultsEight hundred and seventy-three patients (54.4% women) were included. Women were older, smaller and had less coronary artery and lung disease but tended to have higher logistic EuroSCOREs. Smaller prostheses were used more often in women. Major vascular complications occurred more frequently in women (5.5% vs 1.8%, pConclusionsAsian women had significantly smaller stature and anatomy with some differences in clinical profiles. Despite more frequent major vascular complications, women had similar 30-day stroke or mortality rates. Functional status improvement was significant and comparable between the sexes. Conduction disturbance and permanent pacemaker requirements were similar as was 1-year survival.

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.

BACKGROUND Access-site complications during transfemoral transcatheter aortic valve implantation (TF-TAVI) cause serious issues in the future, if unresolved, but the best strategies to manage these complications remains unclear. This study aimed to comprehensively assess access-site complications during percutaneous TF-TAVI in terms of their management. METHODS Using the prospective, multicentre, observational registry OCEAN (Optimized Transcatheter Valvular Intervention), 1497 patients who underwent percutaneous TF-TAVI between October 2013 and May 2017 were identified. The incidence, predictors, temporal changes, and prognosis of access-site complications along with its treatment strategy and re-intervention rate were evaluated. RESULTS Access-site complications occurred in 105 patients (7.0%) and was predicted with lower body-mass-index (OR, 0.94; 95% CI; 0.89-0.99; p = 0.03) and higher sheath-to-femoral-artery-ratio (OR, 1.12; 95% CI, 1.03-1.24; p < 0.002). The incidence of access-site complications declined over time, irrespective of the increasing number of percutaneous TF-TAVI cases. Access-site complications were treated by conservative therapy (n = 19, 18%), interventional procedures (n = 42, 40%), rescue surgical repair (SR) (n = 10, 10%), and primary SR (n = 34, 32%). The severity of complications differed but the re-intervention rate was similar among 4 groups (p = 0.46). Re-intervention was not needed, except for a case of common femoral artery stenosis/occlusion induced by ProGlide. The need for all SRs decreased annually. Access-site complications were not associated with 30 days- and 1 year-survival rate. CONCLUSIONS The incidence of access-site complications was not low but has declined annually. Access-site complications are not related to worse outcomes after successful management. Interventional procedure is acceptable as the first-line strategy to treat access-site complications.

Background: Current guidelines recommend dual antiplatelet therapy for the first 1 to 6 months after transcatheter aortic valve replacement (TAVR); however, recent studies have reported better outcomes with single antiplatelet therapy than with dual antiplatelet therapy in the occurrence of bleeding events, while not increasing thrombotic events. However, no data exist about optimal single antiplatelet therapy following TAVR. Methods: Patients who underwent TAVR between October 2013 and May 2017 were enrolled from the OCEAN-TAVI Japanese multicenter registry (Optimized Transcatheter Valvular Intervention). After excluding 1759 patients, 829 who received aspirin (100 mg/d) or clopidogrel (75 mg/d) after TAVR were identified and stratified according to the presence or absence of anticoagulation. Propensity score matching was performed to adjust the baseline characteristics between the aspirin and clopidogrel groups. Outcomes of interest were all-cause and cardiovascular deaths, stroke, and life-threatening or major bleeding within 2 years following TAVR. Results: After propensity score matching, 98 and 157 pairs of patients without and with anticoagulation, respectively, were identified. Falsification end points of pneumonia, urinary tract infection, and hip fracture were evaluated, and their rates were not different between groups. All-cause deaths were not statistically different between the groups in patients with (aspirin, 17.5%; clopidogrel, 11.1%; log-rank P =0.07) and without (aspirin, 29.6%; clopidogrel, 20.1%; log-rank P =0.15) anticoagulation at 2 years post-TAVR, whereas clopidogrel was associated with a lower cardiovascular mortality at 2 years in patients with (aspirin, 8.5%; clopidogrel, 2.7%; log-rank P =0.03) and without (aspirin, 18.0%; clopidogrel, 5.2%; log-rank P =0.02) anticoagulation. Conclusions: We demonstrated that clopidogrel monotherapy was associated with a lower incidence of cardiovascular death compared with aspirin monotherapy during the 2-year follow-up after TAVR regardless of anticoagulation use. Registration: URL: https://upload.umin.ac.jp ; Unique identifier: UMIN000020423.

Background In patients undergoing transcatheter aortic valve replacement (TAVR), those with small left ventricle (LV) may have an increased risk of poor outcomes, because small LV is associated with low‐flow (LF), left ventricular hypertrophy. However, the impact of small LV on patients undergoing TAVR remains unknown. Methods and Results We examined 2584 patients who underwent TAVR between October 2013 and May 2017 using data from the Japanese multicenter registry. On the basis of the American Society of Echocardiography guidelines, small LV was defined as left ventricular end‐diastolic dimension P =0.0013) and cardiovascular mortality (8.8% versus 5.5%; adjusted HR, 1.93 [95% CI, 1.25–2.98]; P =0.0028). Propensity score matching analysis showed consistent findings. In subgroup analyses, LF, left ventricular hypertrophy did not interact with small LV. Conclusions Small LV, determined by a simple echocardiographic parameter, was associated with poorer clinical outcomes after TAVR regardless of LF, left ventricular hypertrophy. LV size may be useful for assessing clinical outcomes after TAVR. Registration URL: https://www.umin.ac.jp/ctr/index.htm ; Unique identifier: UMIN000020423.

Background 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. Methods 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). Results Patients with PVD (288 patients, 13.3%) had a higher incidence of in-hospital complications, such as AKI (16.3% vs. 7.0%, p Conclusions 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.

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 score4%, n = 467 [18%]), intermediate-risk (4%≤ STS score8%, 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 (p0.001).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.

New-onset atrial tachyarrhythmia (ATA) often develops after atrial septal defect (ASD) closure. Its development raises some potential concerns such as stroke and bleeding complications caused by anticoagulant therapy and limited access to the left atrium for catheter ablation. Although it is essential to identify the risk factors of new-onset ATA, few studies have examined these factors. This study investigated unknown risk factors for the development of new-onset ATA after transcatheter ASD closure in patients without a history of ATA.A total of 238 patients without a history of ATA, aged ≥18 years and who underwent transcatheter ASD closure at the current hospital were reviewed. Patient characteristics were compared between the groups with and without new-onset ATA. The factors associated with new-onset ATA were examined using univariate and multivariable analyses.Thirteen (13) (5.5%) patients experienced ATA during follow-up (mean, 21±14 months). Compared with patients without new-onset ATA, patients with new-onset ATA were older (48±18 vs 66±11 years; p0.001) and had high brain natriuretic peptide (BNP) levels (36±36 vs 177±306 pg/mL; p0.001). On multivariable analysis, BNP ≥40 pg/mL before ASD closure was associated with new-onset ATA after adjusting for age (OR, 4.91; 95% CI, 1.22-19.8; p=0.025).Patients with BNP levels40 pg/mL before transcatheter ASD closure may have a higher risk of developing new-onset ATA.

Aims Frequent nightmares can pose a serious clinical problem, especially in association with sleep and psychological disturbances, in the general population. However, this association has not been investigated in inpatients with cardiovascular (CV) diseases. Furthermore, whether CV medications could induce iatrogenic nightmares remains unknown. In a cross-sectional designed study, we evaluated the prevalence and determinants of frequent nightmares and its association with sleep and psychological disturbances among hospitalized CV patients. Methods and results A total of 1233 patients (mean age, 64 ± 15 years; 25.1% female) hospitalized for various CV diseases in a single university hospital were enrolled. We assessed nightmares and sleep characteristics using the Pittsburgh Sleep Quality Index (PSQI), sleep-disordered breathing (SDB) using nocturnal pulse oximetry, and psychological disturbances using Hospital Anxiety and Depression Scale (HADS). Overall, 14.8% and 3.6% of the patients had at least one nightmare per month and per week (frequent nightmares), respectively. In this cohort, 45.9% had insomnia (modified PSQI > 5), 28.0% had SDB (3% oxygen desaturation index > 15), 18.5% had depression (HADS-depression ≥ 8), and 16.9% had anxiety (HADS-anxiety ≥ 8). Frequent nightmares were not associated with CV medications and SDB but were associated with depression [odds ratio (OR) = 4.61, 95% confidence interval (CI) = 2.03–10.48], anxiety (OR = 5.32, 95% CI = 2.36–12.01), and insomnia (OR = 7.15, 95% CI = 2.41–21.22). Conclusions Frequent nightmares were not uncommon in patients hospitalized for CV diseases. Although the cause–effect relationship is unclear, frequent nightmares were associated with psychological disturbances and insomnia, but not iatrogenic factors, among hospitalized CV patients. Cardiologists should be more conscientious to nightmare complaints with respect to screening for psychological disturbances and insomnia.

OBJECTIVES To compare safety, efficacy, and hemodynamics of transfemoral transcatheter aortic valve replacement (TAVR) using self-expanding and balloon-expandable transcatheter heart valves (THVs) in patients with a small aortic annulus. BACKGROUND Few studies have directly compared TAVR outcomes using third-generation THVs, focusing on patients with small aortic annuli. METHODS In a multicenter TAVR registry, we analyzed data from 576 patients with a small annulus and who underwent transfemoral TAVR using third-generation THVs. Propensity score matching was used to adjust baseline clinical characteristics. RESULTS The device success rate in the overall cohort was 92.0% (Evolut R: 92.1% vs. Sapien 3:92.0%, p = 0.96). One year after TAVR, patients treated with Evolut R maintained a lower mean pressure gradient (mPG) and a higher indexed effective orifice area (iEOA) in the matched cohort {mPG: 9.0 [interquartile range (IQR): 6.0-11.9] vs. 12.0 [IQR: 9.9-16.3] mmHg, p

Information on early to late-phase kidney damage in patients who underwent transcatheter aortic valve replacement (TAVR) is scarce. We aimed to identify the predictive factors for late kidney injury (LKI) at 1-year and patient prognosis beyond 1-year after TAVR.We retrospectively reviewed 1,705 patients' data from the Japanese TAVR multicenter registry. Acute kidney injury (AKI) and LKI, defined as an increase of at least 0.3 mg/dL in creatinine level, a relative 50% decrease in kidney function from baseline to 48 hours and 1-year, were evaluated. The patients were categorized into the 4 groups as AKI-/LKI- (n = 1.362), AKI+/LKI- (n = 95), AKI-/LKI+ (n = 199), and AKI+/LKI+ (n = 46).The cumulative 3-year mortality rates were significantly increased across the four groups (12.5%, 15.8%, 24.6%, 25.8%, P.001). Multivariate analysis revealed that chronic kidney disease, coronary artery disease, periprocedural AKI, and heart failure-related re-admission within 1-year were significantly associated with LKI. The Cox regression analysis revealed that AKI-/LKI+ and AKI+/LKI+ were independent predictors of increased late mortality beyond 1-year after TAVR (P = .001 and P = .01).LKI was influenced by adverse cardio-renal events and was associated with increased risks of late mortality beyond 1-year after TAVR.

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 of150 × 10

Background The SALUTE trial was a prospective, multicenter, single-arm trial to confirm the safety and efficacy of the WATCHMAN left atrial appendage closure (LAAC) device for stroke prevention in patients with nonvalvular atrial fibrillation (NVAF) in Japan.Methods and Results:A total of 54 subjects (including 12 roll-in subjects) with a WATCHMAN implant procedure were followed in 10 investigational centers. Follow-up visits were performed up to 2 years post-implant. The baseline CHA2DS2-VASc score was 3.6±1.6 and the baseline HAS-BLED score was 3.0±1.1. All 42 subjects in the intention to treat (ITT) cohort underwent successful implantation of the LAAC device without any serious complications, achieving the prespecified performance goal. The effective LAAC rate was maintained at 100% from 45 days to 12 months post-implant, achieving the prespecified performance goal. During follow-up, 1 subject died of heart failure, and 3 had ischemic strokes, but there were no cases of hemorrhagic stroke or systemic embolism. All events were adjudicated as unrelated to the WATCHMAN device/procedure by the independent Clinical Events Committee. All 3 ischemic strokes were classified as nondisabling based on no change in the modified Rankin scale score. Conclusions Final results of the SALUTE trial demonstrated that the WATCHMAN LAAC device is an effective and safe alternative nonpharmacological therapy for stroke risk reduction in Japanese NVAF patients who are not optimal candidates for lifelong anticoagulation. (Trial Registration: clinicaltrials.gov Identifier NCT03033134).

Objectives Estimating 1‐year life expectancy is an essential factor when evaluating appropriate indicators for transcatheter aortic valve replacement (TAVR). Background It is clinically useful in developing a reliable risk model for predicting 1‐year mortality after TAVR. Methods We evaluated 2,588 patients who underwent TAVR using data from the Optimized CathEter vAlvular iNtervention (OCEAN) Japanese multicenter registry from October 2013 to May 2017. The 1‐year clinical follow‐up was achieved by 99.5% of the entire population (n = 2,575). Patients were randomly divided into two cohorts: the derivation cohort (n = 1,931, 75% of the study population) and the validation cohort (n = 644). Considerable clinical variables including individual patient's comorbidities and frailty markers were used for predicting 1‐year mortality following TAVR. Results In the derivation cohort, a multivariate logistic regression analysis demonstrated that sex, body mass index, Clinical Frailty Scale, atrial fibrillation, peripheral artery disease, prior cardiac surgery, serum albumin, renal function as estimated glomerular filtration rate, and presence of pulmonary disease were independent predictors of 1‐year mortality after TAVR. Using these variables, a risk prediction model was constructed to estimate the 1‐year risk of mortality after TAVR. In the validation cohort, the risk prediction model revealed high discrimination ability and acceptable calibration with area under the curve of 0.763 (95% confidence interval, 0.728–0.795, p

Background Depression and anxiety are common mental health problems that are strongly associated with sleep disturbances, according to community-based researches. However, this association has not been investigated among patients admitted for cardiovascular diseases (CVDs). We examined the prevalence of depression and anxiety in inpatients with various CVDs and their association with sleep disturbances. Materials and methods This cross-sectional study included 1294 patients hospitalized for CVDs in a Japanese university hospital were evaluated for their mental status using the Hospital Anxiety and Depression Scale (HADS), for sleep-disordered breathing (SDB) using pulse oximetry, and for sleep quality using the Pittsburgh Sleep Quality Index (PSQI). Results Patient characteristics were as below: mean age, 63.9±14.7 years; 25.7% female. Overall, 18.9% had depression (HADS-depression≥8) and 17.1% had anxiety (HADS-anxiety≥8). The presence of depression was associated with female sex, older age, higher plasma brain natriuretic peptide level, lower estimated glomerular filtration rate, and the prevalence of heart failure. Overall, 46.5% patients were categorized as having a poor sleep quality (PSQI>5), and 28.5% patients had SDB (3% oxygen desaturation index>15). Although depression and anxiety were not associated with SDB, they were independently associated with poor sleep quality (OR = 3.09, 95% CI 2.19–4.36; OR = 3.93, 95% CI 2.71–5.69, respectively). Conclusions Depression and anxiety were not uncommon in patients with CVDs. Poor sleep quality could be an important risk factor linked to psychological disturbances.

OBJECTIVES The purpose of this study was to investigate 30-day and 2-year clinical outcomes, and predictors of 2-year mortality in nonagenarians undergoing transcatheter aortic valve implantation (TAVI). BACKGROUND TAVI has been applied to nonagenarians. However, sufficient clinical data in nonagenarians who could benefit from TAVI are limited. METHODS We evaluated the data from the optimized catheter valvular intervention-TAVI registry. Clinical outcomes were compared between patients' age ≥90 years and age

Background: Transcatheter aortic valve replacement (TAVR) is widely used; however, its appropriateness is unknown. We sought to investigate the appropriateness of TAVR. Methods and Results: We assigned appropriateness ratings to patients undergoing TAVR for severe aortic stenosis between October 2013 and May 2017 at 14 Japanese hospitals participating in the optimized transcatheter valvular intervention-transcatheter aortic valve implantation registry according to the US appropriate use criteria for treating severe aortic stenosis. To account for the influence of uncaptured variables on appropriate use criteria ratings, we initially assigned them to a best-case scenario where they were assumed to classify a case to the most appropriate clinical scenario and then to a worst-case scenario where assumed least appropriate. Overall proportion of TAVRs classified as appropriate, maybe appropriate, or rarely appropriate was assessed. In addition, extent of hospital-level variation in rarely appropriate procedures was evaluated. Of 2036 TAVRs (median age [25th, 75th]: 85.0 years [81.0–88.0]; 70.5% female the Society of Thoracic Surgeons Predicted Risk of Mortality score: 6.2% [4.4–8.9]), in the best-case scenario, 177 (8.7%) were not successfully mapped, and 1580 (77.6%) were classified as appropriate, 180 (8.8%) as maybe appropriate, 99 (4.9%) as rarely appropriate, respectively. In the worst-case scenario, the rate of rarely appropriate increased to 6.8%. The majority of rarely appropriate TAVRs was performed in patients with moderate to severe dementia (defined as mini-mental status examination of ≤17), bicuspid aortic valve, or anticipated life expectancy P P Conclusions: In clinical practice, the proportion of rarely appropriate TAVRs ranged from 4.9% to 6.8% with substantial institutional variation. Our study elucidates common clinical scenarios deemed rarely appropriate and clarifies the potential targets of quality improvement. Registration: URL: https://www.umin.ac.jp/ctr/index.htm . Unique identifier: UMIN000020423.

Aim Our aim was to explore changes in nutritional and activity status of patients within 6 months after transcatheter aortic valve replacement (TAVR) and factors affecting malnutrition post-TAVR in this cohort, and to gain understanding of their lifestyle considerations. Methods Using a mixed methods approach, we conducted a prospective, longitudinal survey, consisting of interviews and a questionnaire, of 50 participants aged ≥70 years (mean age, 83 years; 58.0% female) undergoing TAVR. Mini Nutritional Assessment (MNA) and albumin level (to measure nutritional status) and Physical Component Summary (PCS) scores from the 36-item Short Form Health Survey (to measure activity status) were collected at pre-TAVR and 1 month and 6 months post-TAVR. Laboratory data and some index scores (e.g., the Clinical Frailty Scale [CFS] and the Mini-Mental State Examination [MMSE]) assessed before TAVR were collected from medical records as related factors. Results Significant change was observed only in the MNA scores of participants who were assessed as malnourished at pre-TAVR, which improved, but did not reach normal nutritional status. Low-flow low-gradient aortic stenosis (odds ratio [OR]: 166.39, 95% confidence interval [CI]: 5.43-5094.43), higher CFS scores (OR: 2.58, 95% CI: 1.01-6.54), and lower MMSE scores (OR: 0.65, 95% CI: 0.43-0.99) were related to malnutrition post-TAVR. From interviews, three themes emerged: "balancing heart-healthy lifestyle and longstanding habits," "living with aging and disease" and "prospects for the rest of life." Conclusions Our results could be utilized to identify patients at risk of malnutrition post-TAVR, and to provide support with consideration of their lifestyle concerns.

This observational study aimed to examine the extent of early invasive strategy (EIS) utilization in patients with non-ST elevation acute coronary syndrome (NSTE-ACS) according to the National Cardiovascular Data Registry (NCDR) CathPCI risk score, and its association with clinical outcomes. Using a prospective multicenter Japanese registry, 2968 patients with NSTE-ACS undergoing percutaneous coronary intervention within 72 hours of hospital arrival were analyzed. Multivariable logistic regression analyses were performed to determine predictors of EIS utilization. Additionally, adverse outcomes were compared between patients treated with and without EIS. Overall, 82.1% of the cohort (n = 2436) were treated with EIS, and the median NCDR CathPCI risk score was 22 (interquartile range: 14&ndash, 32) with an expected 0.3&ndash, 0.6% in-hospital mortality. Advanced age, peripheral artery disease, chronic kidney disease or patients without elevation of cardiac biomarkers were less likely to be treated with EIS. EIS utilization was not associated with a risk of in-hospital mortality, yet, it was associated with an increased risk of acute kidney injury (AKI) (adjusted odds ratio: 1.42, 95% confidence interval: 1.02&ndash, 2.01) regardless of patients&rsquo, in-hospital mortality risk. Broader use of EIS utilization comes at the cost of increased AKI development risk, thus, the pre-procedural risk-benefit profile of EIS should be reassessed appropriately in patients with lower mortality risk.