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Objective: To evaluate the clinical benefit of pre-procedural antiplatelet therapy in patients undergoing transfemoral (TF) transcatheter aortic valve implantation (TAVI).Methods: OCEAN (Optimized transCathEter vAlvular interveNtion)-TAVI is a prospective, multicentre, observational cohort registry, enrolling 749 patients who underwent TAVI from October 2013 to August 2015 in Japan. We identified 540 patients (median age 85 years, 68.1% female) undergoing TF-TAVI; of these, 80 had no pre-procedural antiplatelet therapy and 460 had antiplatelet therapy. The endpoints were any bleeding (life-threatening, major, and minor bleeding) and thrombotic events (stroke, myocardial infarction, and valve thrombosis) during hospitalisation.Results: Patients with dual antiplatelet therapy (DAPT) had a significantly higher incidence of any bleeding than those with single antiplatelet therapy (SAPT) (36.5% vs 27.5%, p=0.049) and no antiplatelet therapy (36.5% vs 21.3%, p=0.010). Patients without pre-procedural antiplatelet therapy did not experience an increased risk of thrombotic events. In multivariable logistic regression analysis, DAPT before TF-TAVI significantly increased any bleeding compared with SAPT (OR 2.05, 95% CI 1.16 to 3.65) and no antiplatelet therapy (OR 2.30, 95% CI 1.08 to 4.90).Conclusions: The current study demonstrated that DAPT before TF-TAVI increased the risk of bleeding compared with single or no antiplatelet therapy. Lower intensity antiplatelet therapy was not associated with thrombotic events. In modern practice, it might be reasonable to perform TAVI using single or no pre-procedural antiplatelet therapy with an expectation of no increase of adverse events.Trial Registration Number: UMIN-ID; 000020423; Results. [ABSTRACT FROM AUTHOR]

The article presents the results of a study on the effects of diacylglycerol (DAG) and triacylglycerol (TAG) on glucose, lipid metabolism and plasma serotonin levels in lean Japanese. Very-low-density lipoprotein-cholesterol (VLDL-C) levels were higher at 2 and 4 hours after TAG ingestion than DAG. Plasma glucose levels were also higher after TAG ingestion. Plasma serotonin levels were higher in DAG ingestion than TAG by 47.3%.

Objectives: We aimed to assess real-world clinical outcomes of transcatheter aortic valve replacement (TAVR) in Japan.Background: Data are limited concerning procedural safety and valve performance following TAVR in Japanese. A program by an on-site proctor and procedure screening system was applied during TAVR introduction.Methods: We consecutively enrolled 1613 patients who underwent TAVR using data from the Optimized CathEter vAlvular iNtervention (OCEAN) Japanese registry, which consists of 14 centers. Baseline characteristics and procedural outcomes including combined early 30-day non-safety, and mortality rates were assessed among 4 groups, divided into quartiles (Q1-Q4).Results: Most patients were women (70.4%), elderly (84.4 ± 5.1 years), and had a median Society of Thoracic Surgeons score of 6.7(4.7-9.5). The overall 30-day mortality, combined early non-safety, and cumulative 1-year mortality rates were 1.7%, 15.1%, and 11.3%, respectively. Thirty-day mortality was not affected by center experience differences divided into quartiles (1.0%, 2.0%, 2.5%, 1.5%, p = 0.404), whereas 30-day early safety was significantly improved (19.1%, 17.9%, 14.6%, 8.9%, p < 0.001). Thirty-day mortality was 0% under transfemoral on-site proctor. Cox-regression multivariate analysis revealed that male sex, clinical frailty scale, New York Heart Association class, creatinine, albumin, hemoglobin, liver disease, and non-transfemoral approach were independent predictive factors of increased midterm mortality risk.Conclusions: Owning to the global supporting system in Japan, excellent early and midterm outcomes have been achieved to overcome the learning curve of the newly introduced TAVR procedure. [ABSTRACT FROM AUTHOR]

Background: 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.Methods: 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.Results: 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.Conclusions: Among patients with severe AS, PAVI before non-CS reduces the AS severity and may contribute to procedural safety during non-CS. [ABSTRACT FROM AUTHOR]

Despite the wide implementation of transcatheter aortic valve implantation (TAVI), the optimal antithrombotic therapy after TAVI has not been established yet. Owing to the accumulating evidence supporting the efficacy and safety of single antiplatelet therapy (SAPT) over dual antiplatelet therapy, the latest guideline recommends life-long SAPT. However, there is scarce evidence supporting SAPT compared with non-antithrombotic therapy. Given the vulnerability of patients undergoing TAVI in terms of high bleeding risk, the benefit of SAPT may be canceled out by its potential increased bleeding risk. Non-antithrombotic Therapy After Transcatheter Aortic Valve Implantation (NAPT) Trial is a prospective, randomized controlled, open-label blinded endpoint multicenter trial conducted in Japan, testing the non-inferiority of non-antithrombotic therapy compared with aspirin monotherapy in patients who underwent TAVI and had no indications for long-term oral anticoagulation therapy (OAC). Patients who successfully underwent trans-femoral TAVI for severe aortic stenosis with either balloon-expandable or self-expandable valves are eligible for inclusion. Key exclusion criteria are (i) occurrence of perioperative complications (ii) indications of taking antithrombotic drugs for other reasons; (iii) eGFR <30 ml/min/1.73 m2 or hemodialysis or peritoneal dialysis. A total of 360 patients will be randomized (1:1) to aspirin monotherapy vs. non-antithrombotic therapy. The primary outcome is a composite of all-cause mortality, myocardial infarction, stroke, and bleeding. All bleeding events based on the Valve Academic Research Consortium 3 are included as a component of the primary outcome. The NAPT trial will determine the non-inferiority of a non-antithrombotic therapy compared with aspirin monotherapy after TAVI. Central Figure. Study Flow Patients who underwent TF-TAVI without peri-procedural complications are eligible to the study and randomized into either ASA monotherapy or non-antithrombotic strategy. Enrolled patients are followed for at least 1-year (maximum 3 years). Abbreviations: OCEAN-TAVITF-TAVI, transfemoral trans-catheter aortic valve implantation; Afib, atrial fibrillation; AVB, atrio-ventricular block; ASA, aspirin, ECG, electorocardiogram; TTE, transthoracic echocardiography; CT, computed tomography; QOL, quality of life; KCCQ-12, kanzas City Cariomyopathy Questionnaire [Display omitted] [ABSTRACT FROM AUTHOR]

Abstract: Background:: Hyperlipidemia is a major risk factor for ischemic heart disease. Hydroxymethylglutaryl coenzyme A reductase inhibitors (“statins”) (eg, simvastatin) are considered first-line cholesterol-lowering therapy because they are effective and well tolerated, even at high doses. Based on a literature search, no studies have been published concerning the effects of simvastatin 20 mg/d in Japanese patients who had not previously received lipid-lowering treatment. Objective:: The aim of this study was to assess the clinical tolerability and effectiveness of simvastatin 20 mg/d in achieving the target lipid concentrations recommended in the 2002 Japan Atherosclerosis Society (JAS) guidelines in Japanese patients with hyperlipidemia. Methods:: This prospective, open-label pilot study was conducted at Kashiwa Hospital, Jikei University School of Medicine, Kashiwa, Japan. Male and postmenopausal female patients aged ≥18 to 70 years with hyperlipidemia (total cholesterol [TC], ≥220 mg/dL; triglycerides [TG], 150–400 mg/dL) who had not received lipid-lowering medications for at least 6 months before the study were enrolled. Patients received simvastatin 20 mg PO QD for 4 weeks. Effectiveness was assessed using serum concentrations of TC, low-density lipoprotein cholesterol (LDL-C), TG, and lipid peroxide, measured at 0 (baseline) and 4 weeks. Target serum TC and LDL-C concentrations as outlined by the JAS were as follows: category A, TC <240 mg/dL and LDL-C <160 mg/dL; category B1 and B2, TC <220 mg/dL and LDL-C <140 mg/dL; and category C, TC <200 mg/dL and LDL-C <120 mg/dL. A subanalysis of the correlation between baseline high-density lipoprotein cholesterol (HDL-C) and target achievement rates was conducted by baseline HDL-C concentration (<50 or ≥50 mg/dL). Tolerability was assessed using spontaneous reporting of adverse events and laboratory analysis, including liver function tests. Results:: Twenty-two patients participated in the study (16 women, 6 men; mean [SD] age, 56.0 [8.0] years; mean [SD] body mass index, 23.6 [3.4] kg/m2). Mean serum TC, LDL-C, TG, and lipid peroxide concentrations significantly decreased from baseline (changes, −28.6%, −40.4%, −24.0%, and −14.5%, respectively; P < 0.001, <0.001, <0.001, and <0.01, respectively). The mean HDL-C concentration significantly increased from baseline (change, 7.2%; P < 0.001); the mean increase was significantly greater in patients with baseline HDL-C <50 mg/dL compared with those with baseline HDL-C ≥50 mg/dL (changes, 11.3% vs 4.4%; P < 0.05). Target TC and LDL-C concentrations were achieved in 90.9% of patients. No serious adverse events were observed, and liver enzyme and creatine kinase concentrations did not increase to above-normal values. Conclusions:: The results of this study suggest that simvastatin 20 mg/d might be useful in the clinical treatment of hyperlipidemia in Japanese patients. The study drug was well tolerated. [Copyright &y& Elsevier]

Background: The Direct Oral Anticoagulant (DOAC) Score can predict bleeding risk in patients with atrial fibrillation taking DOACs; however, it lacks external validation. Therefore, this study aimed to assess the association between the DOAC Score and bleeding events in patients with atrial fibrillation who underwent transcatheter aortic valve replacement., Methods and Results: This retrospective multicenter cohort study included patients with atrial fibrillation who underwent transcatheter aortic valve replacement, as registered in a Japanese multicenter registry. The primary end point was the incidence of bleeding. Patients were categorized based on their DOAC Score: low and moderate- (≤7 points), high- (8-9 points), and very high-risk (≥10 points) groups. Among 1230 patients (mean age 84.6±5.1 years; 457 men), 465 (37.8%) received a vitamin K antagonist, and the remaining patients received DOACs. The low and moderate-, high-, and very high-risk groups included 380 (30.1%), 497 (40.4%), and 353 patients (28.7%), respectively. The 3-year cumulative incidence of all bleeding events was significantly different among the 3 groups (low and moderate risk: 6.6%, high risk: 6.9%, and very high risk: 14.0%; P <0.01). Multivariable Cox regression analysis revealed that significant increments in the DOAC Score were associated with a risk of all bleeding events at 3 years in the overall cohort (hazard ratio [HR], 1.22 [95% CI, 1.08-1.38]; P <0.01), in the DOAC cohort (HR, 1.20 [95% CI, 1.01-1.42]; P =0.04), and in the vitamin K antagonist cohort (HR, 1.25 [95% CI, 1.04-1.50]; P =0.02)., Conclusions: The DOAC Score was significantly associated with bleeding events in patients with atrial fibrillation after transcatheter aortic valve replacement, aiding in clinical decision-making for anticoagulant management., Registration: URL: https://center6.umin.ac.jp/cgi-open-bin/ctr&#95;e/ctr&#95;view.cgi?recptno=R000023585; Unique identifier: UMIN000020423.

In response to the International Commission on Radiological Protection, which lowered the lens equivalent dose limit, Japan lowered the lens dose limit from 150 mSv y -1 to 100 mSv/5 years and 50 mSv y -1 , with this new rule taking effect on 1 April 2021. DOSIRIS ® is a dosimeter that can accurately measure lens dose. Herein, we investigated lens dose in interventional cardiology physicians 1 year before and after the reduction of the lens dose limit using a neck dosimeter and lens dosimeter measurements. With an increase in the number of cases, both personal dose equivalent at 0.07 mm depth [Hp(0.07), neck dosimeter] and personal dose equivalent at 3 mm depth [Hp(3), lens dosimeter] increased for most of the physicians. The Hp(3) of the lens considering the shielding effect of the Pb glasses using lens dosimeter exceeded 20 mSv y -1 for two of the 14 physicians. Protection from radiation dose will become even more important in the future, as these two physicians may experience radiation dose exceeding 100 mSv/5 years. The average dose per procedure increased, but not significantly. There was a strong correlation between the neck dosimeter and lens dosimeter scores, although there was no significant change before and after the lens dose limit was lowered. This correlation was particularly strong for physicians who primarily treated patients. As such, it is possible to infer accurate lens doses from neck doses in physicians who primarily perform diagnostics. However, it is desirable to use a dosimeter that can directly measure Hp(3) because of the high lens dose., (© 2024 Society for Radiological Protection. Published on behalf of SRP by IOP Publishing Limited. All rights, including for text and data mining, AI training, and similar technologies, are reserved.)

Aims: A considerable proportion of candidates for transcatheter aortic valve implantation (TAVI) have underlying heart failure (HF) with preserved ejection fraction (HFpEF), which can be challenging for diagnosis because significant valvular heart disease should be excluded before diagnosing HFpEF. This study investigated the long-term prognostic value of the pre-procedural H 2 FPEF score in patients with preserved ejection fraction (EF) undergoing TAVI., Methods and Results: Patients who underwent TAVI between October 2013 and May 2017 were enrolled from the Optimized CathEter vAlvular iNtervention-Transcatheter Aortic Valve Implantation Japanese multicentre registry. After excluding 914 patients, 1674 patients with preserved EF ≥ 50% (median age: 85 years, 72% female) were selected for calculation of the H 2 FPEF score and were dichotomized into two groups: the low H 2 FPEF score [0-5 points; n = 1399 (83.6%)] group and the high H 2 FPEF score [6-9 points; n = 275 (16.4%)] group. Patients with high H 2 FPEF scores were associated with a higher prevalence of New York Heart Association Functional Class III/IV (59.3% vs. 43.7%, P < 0.001), diabetes (24.4% vs. 18.5%, P = 0.03), and paradoxical low-flow, low-gradient aortic stenosis (15.9% vs. 6.2%, P < 0.001). These patients showed worse prognoses than those with low H 2 FPEF scores regarding the cumulative 2 year all-cause mortality (26.3% vs. 15.5%, log-rank P < 0.001), cardiovascular mortality (10.5% vs. 5.4%, log-rank P < 0.001), HF hospitalization (16.2% vs. 6.7%, log-rank P < 0.001), and the composite endpoint of cardiovascular mortality and HF hospitalization (23.8% vs. 10.8%, log-rank P < 0.001). After adjustment for several confounders, the high H 2 FPEF scores were independently associated with increased risk for all-cause mortality [adjusted hazard ratio (HR), 1.48; 95% confidence interval (CI), 1.09-2.00; P = 0.011] and for the composite endpoint of cardiovascular mortality and HF hospitalization (adjusted HR, 1.95; 95% CI, 1.38-2.74; P < 0.001). Subgroup analysis confirmed the excess risk of high H 2 FPEF scores relative to low H 2 FPEF scores for the composite endpoint of cardiovascular mortality and HF hospitalization increased with a lower Society of Thoracic Surgeons (STS) score (STS score <8%: adjusted HR, 2.40; 95% CI, 1.50-3.85; P < 0.001; STS score ≥8%: adjusted HR, 1.34; 95% CI, 0.79-2.28; P = 0.28; P interaction  = 0.030)., Conclusions: The H 2 FPEF score is useful for predicting long-term adverse outcomes after TAVI, including all-cause mortality, cardiovascular mortality, and HF hospitalization for patients with preserved EF. More aggressive interventions targeting HFpEF in addition to the TAVI procedure might be relevant in patients with high H 2 FPEF scores, particularly in those with a lower surgical risk., (© 2024 The Authors. ESC Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Background: Japanese patients undergoing transcatheter aortic valve replacement (TAVR) are often female and have a small body size, potentially impacting bleeding risk with antithrombotic therapy. Outcomes of direct oral anticoagulant use in these patients with atrial fibrillation (AF) need to be clarified., Methods and results: This prespecified analysis included Japanese patients from ENVISAGE-TAVI AF, a prospective, randomized, open-label, adjudicator-masked trial that compared treatment with edoxaban and vitamin K antagonists (VKAs) in patients with AF after TAVR. The primary efficacy and safety outcomes were net adverse clinical events (NACE; composite of all-cause death, myocardial infarction, ischemic stroke, systemic embolic event, valve thrombosis, and International Society on Thrombosis and Haemostasis [ISTH]-defined major bleeding) and ISTH-defined major bleeding, respectively. Intention-to-treat (ITT) and on-treatment analyses were performed. Overall, 159 Japanese patients were enrolled (edoxaban group: 82, VKA group: 77) and followed for on average 483 days. Mean patient age was 83.8 years; 52.2% were female. In the ITT analysis, NACE rates were 10.9%/year with edoxaban and 12.5%/year with VKA (hazard ratio [HR], 0.85; 95% confidence interval [CI], 0.38-1.90); major bleeding occurred in 8.9%/year and 7.3%/year, respectively (HR, 1.17; 95% CI, 0.45-3.05). In edoxaban- and VKA-treated patients, rates of ischemic stroke were 1.8%/year and 1.0%/year, respectively; fatal bleeding rates were 0.9%/year and 2.0 %/year. On-treatment results were similar to ITT., Conclusions: In Japanese patients with AF after successful TAVR, edoxaban and VKA treatment have similar safety and efficacy profiles.

Objective: Transcatheter 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., Methods: A 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., Results: Among 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 (p<0.001). Poor SI with preprocedural NYHA class 2 had a worse outcome than SI with preprocedural NYHA class ≥3., Conclusions: Poor 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 Number: This 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)., Competing Interests: Competing interests: MY, NT, TN, SS, KM, MT, HU, YW and KH are clinical proctors for Edwards Lifesciences and Medtronic. HS and KT are clinical proctors for Edwards Lifesciences., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Objective: Data 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., Design: Observational study., Setting: This study included patients with AS from a Japanese multicentre registry who underwent TAVI., Participants: The 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., Interventions: We classified patients based on statin at admission and identified 936 matched pairs after propensity score matching., Primary and Secondary Outcome Measures: The outcomes were all-cause and cardiovascular mortality., Results: The 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), p<0.01)., Conclusions: Statin 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 Number: UMIN000020423., Competing Interests: Competing interests: MYamam, NT, TN, SS, KM, MTab, HU and YW are clinical proctors for Edwards Lifesciences and Medtronic. HS, KT and KH are clinical proctors for Edwards Lifesciences. TI received a research grant from Boston Scientific., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

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 < .001; iEOA: 1.20 [IQR: 1.01-1.46] vs. 1.08 [IQR: 0.90-1.28] cm 2 /m 2 , p < .001}. However, no significant differences were reported in the incidence of severe prosthesis-patient mismatch and aortic regurgitation at 1 year. Furthermore, both groups showed comparable outcomes with no differences in terms of all-cause mortality (log-lank test, p = .81)., Conclusions: TAVR for patients with a small annulus using third-generation THVs was associated with high device success. Evolut R seems to be superior to Sapien 3 in hemodynamic performance for patients with a small annulus and body surface area up to 1 year after TAVR. Nevertheless, all-cause mortality at 1 year was similar between both groups., (© 2020 Wiley Periodicals LLC.)

Data on the accurate onset date and serial changes of the complete atrioventricular block (CAVB) after transcatheter aortic valve implantation (TAVI) are limited. This study aimed to assess the incidence, timing, and potential recovery of CAVB following TAVI. Total 696 patients who underwent TAVI were enrolled. Acute CAVB was evaluated within 24 h; delayed CAVB was evaluated 24 h after TAVI. Recovered CAVB was defined as ventricular pacing < 1% during the follow-up or transit block without the need for permanent pacemaker implantation (PMI). The other patients with CAVB were categorized as continued CAVB. Clinical differences between the recovered and continued CAVB groups were evaluated, and the predictive factors of continued CAVB were assessed. The incidence rates of CAVB, acute CAVB, and delayed CAVB were 6.9% (48/696), 4.6% (32/696), and 2.3% (16/696), respectively. Overall, 47.9% (23/48) of patients had recovered CAVB, which was more prevalent in the acute CAVB group than in the delayed CAVB group [59.4% (19/32) vs. 25.0% (4/16), p = 0.025]. CAVB recovery occurred within 24 h (61.0%, 14/23) and after 24 h (39.0%, 9/23). Before CAVB recovery, 21.7% (5/23) of patients had already undergone PMI. A pre-existing complete right bundle branch block (CRBBB) was the only independent predictive factor of continued CAVB (odds ratio 4.51, 95% confidence interval 1.03-19.6, p = 0.045). In conclusion, a pre-existing CRBBB and the timing and prolonged duration of CAVB may be used in risk stratification to determine the appropriateness of early discharge, optimal PMI date, and PMI indication.

Background: The balloon-expandable SAPIEN 3 (S3) is superior to the older-generation balloon-expandable SAPIEN XT (XT) in a lower incidence of paravalvular aortic regurgitation, lower complication rates and better survival in transcatheter aortic valve implantation (TAVI). However, prosthesis-patient mismatch (PPM) more frequently occurs in S3 than XT. Further, little information is available on PPM after TAVI using S3 in Asians. This study aims to determine the incidence and predictors of PPM in S3 by focusing on the difference between S3 and XT using data from a Japanese multicentre registry., Methods: From the Optimised transCathEter vAlvular iNtervention-TAVI (OCEAN-TAVI) registry, 2134 patients undergoing TAVI using S3 or XT were included. PPM was defined as moderate if ≧0.65 but ≦0.85 cm 2 /m 2 or severe if <0.65 cm 2 /m 2 at the indexed effective orifice area by postprocedural echocardiography., Results: The incidence of moderate and severe PPM in S3 was 13.3% and 1.3%, respectively. The 20 mm transcatheter heart valve (THV) was more frequently used in S3 than XT (7.4% vs 2.4%, p<0.0001). PPM was more frequently observed in S3 than XT (14.7% vs 8.8%, p<0.0001). Multivariate logistic regression analysis revealed S3 predicted PPM (OR 1.92 (95% CI 1.35 to 2.74), p=0.0003). The mutual predictors for PPM between S3 and XT were younger age, larger body surface area, smaller aortic valve area, no balloon postdilatation and the use of 20 mm and 23 mm THV. When comparing 23 mm, 26 mm and 29 mm S3, the ORs of 20 mm S3 were 5.67 (95% CI 2.88 to 11.12), 19.24 (95% CI 8.13 to 46.86) and 51.03 (95% CI 12.28 to 280.77), respectively., Conclusions: The incidence of PPM after TAVI using S3 was 14.6% overall in this Asian population. PPM was more frequently observed in S3 than XT. A considerable number of patients were treated by the 20 mm S3 in an Asian cohort. The 20 mm THV was identified as a strong predictor for PPM., Competing Interests: Competing interests: NT, MY, TN, SS, KM, MT, HU and YW are clinical proctors for Edwards Lifesciences and Medtronic. KT and KH are clinical proctors of Edwards Lifesciences., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

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 × 10 9 /L and was classified into moderate/severe (<100 × 10 9 /L) and mild (≧100-<150 × 10 9 /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., Competing Interests: Declaration of interests The authors declare that they have no known competing financial interests or personal relations that could have appeared to influence the work reported in this study., (Copyright © 2020 Elsevier Inc. All rights reserved.)

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.

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.

Objectives: Patients' backgrounds and clinical outcomes in urgent/emergent/salvage transcatheter aortic valve replacement (Em-TAVR) remain unclear. We investigated patient characteristics and the mortality in Em-TAVR and the predictors for the need for Em-TAVR., Methods: We consecutively enrolled 1613 patients undergoing TAVR for severe aortic stenosis between October 2013 and July 2016 from the Optimised transCathEter vAlvular interventioN (OCEAN)-transcatheter aortic valve implantation (TAVI) registry. The urgency was based on the European System for Cardiac Operative Risk Evaluation II. Urgent, emergent or salvage were included with the Em-TAVR group and elective with the El-TAVR group., Results: Em-TAVR was observed in 87 (5.4%) patients. A higher Clinical Frailty Scale (CFS), peripheral artery disease (PAD), hypoalbuminaemia, reduced left ventricular ejection fraction (LVEF) and preoperative at least moderate mitral regurgitation (MR) predicted the need for the Em-TAVR by the multivariate logistic regression analysis. The Em-TAVR group had the higher Society of Thoracic Surgeons Score (13.7 (IQR 8.2-21.0) vs 6.5 (IQR 4.6-9.2); p<0.001) and higher 30-day mortality (9.2% vs 1.3%; p<0.001) than the El-TAVR group. Accordingly, Kaplan-Meier analysis showed that the cumulative mortality was higher in the Em-TAVR group than that in the El-TAVR group (log-rank; p<0.001). However, Em-TAVR did not predict mortality in the multivariate Cox regression analysis., Conclusions: Em-TAVR was performed in 5.4% of patients. Higher CFS, PAD, hypoalbuminaemia, reduced LVEF and preprocedural MR predicted the need for Em-TAVR. Em-TAVR was not a predictor for mortality in the multivariate analysis, suggesting that it is a reasonable treatment option., Competing Interests: Competing interests: NT, MY, TN, SS, KM, HU, YW, and MT are clinical proctors for Edwards Lifesciences and Medtronic. KT and KH are clinical proctors of Edwards Lifesciences., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.)

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., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Limited data exist on the comparison of clinical outcomes after first- and second-generation drug-eluting stent (DES) thrombosis. From the Retrospective Multicenter Registry of Stent Thrombosis (ST) After First- and Second-Generation DES Implantation registry, this study evaluated 655 ST patients (first-generation DES thrombosis [G1-ST], n = 342; second-generation DES thrombosis [G2-ST], n = 313). After propensity score matching, the final study population consisted of 159 matched patients. The primary end point was the cumulative 1-year incidence of mortality. The mortality after G2-ST at 1 year was similar to that after G1-ST (23.0% vs 22.9%, p = 0.76). Also, the G2-ST group showed a significantly lower rate of target lesion revascularization than the G1-ST group (9.7% vs 17.1%, p = 0.01). Risk factors of 1-year mortality included cardiogenic shock or arrest at the time of ST, multivessel ST, left ventricular ejection fraction ≤40%, advanced age, and final thrombolysis in myocardial infarction flow grade ≤2. In conclusion, patients with G2-ST showed a similar 1-year mortality to those with G1-ST, highlighting that ST remains a life-threatening complication in the second-generation DES era., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: The influence of improved mitral regurgitation (MR) on the outcomes of transcatheter aortic valve replacement (TAVR) is unknown. Our aim was to determine the impact of significant preprocedural MR and the improvement of MR after TAVR., Methods: A population of 1587 patients from the Optimized Catheter Valvular Intervention Transcatheter Aortic Valve Implantation (OCEAN-TAVI) registry were evaluated. Preprocedural MR was mild or less in 1443 patients (90.9%) and moderate or severe in 144 patients (9.1%)., Results: Moderate or severe MR was associated with increased risk for all-cause mortality at 1 year (adjusted hazard ratio, 1.85; 95% confidence interval [CI], 1.20-2.84; P = 0.005) and 2 years (adjusted hazard ratio, 1.64; 95% CI, 1.15-2.34; P = 0.007). At 6 months after TAVR, the MR grade improved in 77.4% of the patients with moderate or severe baseline MR. Multivariate analysis showed that the absence of previous myocardial infarction (odds ratio, 8.00; 95% CI, 1.74-36.8; P = 0.008) and beta-blocker use at baseline (odds ratio, 2.71; 95% CI, 1.09-6.70; P = 0.031) were independently associated with improved MR at 6 months (vs unchanged, worsened MR, or death). Patients with improved MR had a significantly lower rate of midterm readmission for heart failure (11.6%) than those with unchanged or worsened MR (30.8%, P = 0.007)., Conclusions: Moderate or severe MR was associated with increased risk of all-cause mortality 2 years after TAVR. Moderate or severe baseline MR was improved in most patients at 6 months after TAVR. Patients with unchanged or worsened MR had an increased rate of readmission for heart failure., (Copyright © 2019 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.)

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 cm 2 /m 2 . 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., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Skeletal muscle mass (SMM) as calculated by computed tomography (CT) is a predictor of all-cause mortality after transcatheter aortic valve replacement (TAVR), but it remains unclear whether using CT-determined density of skeletal muscle has additive prognostic value. We utilized the Japanese multicenter registry data of 1375 patients who underwent CT prior to TAVR. Sarcopenia status was defined by the CT-derived SMM index (threshold: men, 55.4 cm 2 /m 2 ; women, 38.9 cm 2 /m 2 ). The threshold for high and low CT density was based on the median value of the entire cohort (men: 33.4 HU; women: 29.5 HU). Sarcopenia was observed in 802 patients (58.3%) overall. Patients were categorized into non-sarcopenia and high-CT density (n = 298), non-sarcopenia and low-CT density (n = 275), sarcopenia and high-CT density (n = 399), and sarcopenia and low-CT density (n = 403) groups, and procedural outcomes and mortality compared. The cumulative 3-year mortality rates in these groups were 18%, 27%, 24%, and 32%, respectively. Cox-regression multivariate analysis revealed that low-CT density (compared with high-CT density) and sarcopenia and low-CT density (compared with non-sarcopenia and high-CT density as reference) increased mortality after TAVR (hazard ratios [HR]: 1.35 and 1.43, 95% confidence intervals [Cis]: 1.06-1.72 and 1.00-2.08, p = 0.01, and 0.049, respectively). However, sarcopenia alone was not related to an increased risk of mortality (HR 1.30, 95% CI 0.99-1.69, p = 0.52). In conclusion, CT density-based skeletal muscle quality assessment combined with the SMM index improves prediction of adverse outcomes after TAVR.

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 <1 year. There was substantial variation in the proportion of rarely appropriate TAVR across hospitals (median rate of rarely appropriate: 4.9% [3.8-6.6] in the best-case scenario, P <0.001; 6.5% [5.6-8.6] in the worst-case scenario, P <0.001)., 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.

Objective: This study aimed to assess the effect of chronic steroid use on periprocedural complications and clinical outcomes after transcatheter aortic valve replacement (TAVR)., Background: Chronic steroid use increases the risk of periprocedural complications and mortality during surgery., Methods: We investigated 1,313 consecutive patients with aortic stenosis who underwent transfemoral (TF)-TAVR using data from a Japanese multicenter registry. The baseline characteristics, periprocedural complications including vascular complications (VCs), access route related VCs, and clinical outcomes were compared between patients in the steroid group and nonsteroid group., Results: Major VCs and access route VCs occurred more in the steroid group than in the nonsteroid group (13.4 vs. 5.8%, p = .019; 20.9% vs. 9.8%, p = .004). Especially in the surgical cut-down group, the rate of access route VCs was differed between the two groups (28.0% vs. 7.5%, p = .003). The 30-day mortality rates were similar between the two groups (0% vs. 1.4%, p = .39). In the propensity score-matched model, the higher incidence of major VCs in the steroid group was maintained, although early mortality was similar in the two groups., Conclusions: Although chronic steroid therapy is not associated with increased early mortality, chronic steroid use may affect periprocedural VCs and access route VCs mainly due to surgical cut-down in patients following TF-TAVR., (© 2019 Wiley Periodicals, Inc.)

Objectives: This study aimed to compare the clinical impact of mild postprocedural aortic regurgitation (post-AR) to that of none-trivial post-AR after transcatheter aortic valve implantation (TAVI) and to identify the vulnerability factors to mild post-AR., Background: Moderate-severe post-AR, associated with increased mortality, is an important issue. However, the clinical impact of mild post-AR remains controversial., Methods and Results: We analyzed data from 1,572 consecutive patients (1,026 of none-trivial post-AR and 546 of mild post-AR) obtained from the Optimized transCathEter vAlvular Intervention (OCEAN-TAVI) Japanese multicenter registry. We evaluated the 1-year cumulative cardiovascular death and re-hospitalization rates for heart failure (HF) after TAVI according to the degree of post-AR. Kaplan-Meier curves showed no significant difference between "none-trivial post-AR" and "mild post-AR" in terms of cardiovascular death, but a significant difference was noted in the cumulative incidence of re-hospitalization for HF between the two groups (hazard ratio 1.57, 95% confidence interval 1.02-2.41, p = .04). In the stratified analysis, only in patients with not more than 50% of left ventricular ejection fraction (LVEF), concentric left ventricular hypertrophy (LVH), and none-trivial pre-procedural aortic regurgitation (pre-AR), mild post-AR resulted in a higher incidence of re-hospitalization for HF., Conclusions: In this study, the clinical impact of mild post-AR compared to none-trivial post-AR tended to be augmented in the presence of reduced LVEF, concentric LVH, and none-trivial pre-AR. Pre-procedure echocardiographic findings including LVEF, left ventricular geometry, and pre-AR may help to judge the necessity of postdilatation in case of mild post-AR just after the bioprosthesis deployment., (© 2019 Wiley Periodicals, Inc.)

Pre-procedural valvuloarterial impedance (Zva) is considered as a useful predictor of mortality in patients diagnosed as having severe aortic stenosis (AS) who undergo transcatheter aortic valve implantation (TAVI). However, the prognostic significance of post-procedural Zva remains unclear. We aimed to evaluate the prognostic significance of Zva after TAVI. We retrospectively analyzed the clinical and echocardiographic data of 1004 consecutive elderly patients (median 84 years old, 27.5% men) who underwent TAVI for severe symptomatic AS. Zva was calculated after TAVI, and patients were divided into three groups based on tertile values: the high [> 3.33 (n = 335)], intermediate [2.49-3.33 (n = 334)], and low Zva groups [< 2.49 (n = 335)]. The estimated 2-year all-cause and cardiovascular mortalities using Kaplan-Meier analysis were 16.2% [95% confidence interval (CI) 11.8-20.4] and 5.9% (95% CI 3.2-8.6), respectively. There were no significant intergroup differences in each endpoint (long-rank p = 0.518 for all-cause mortality, p = 0.757 for cardiovascular mortality). Multivariable Cox regression analyzes with adjustments of patient characteristics and medications showed that the post-procedural Zva was not associated with the 2-year all-cause mortality [intermediate Zva group versus (vs.) low Zva group: adjusted hazard ratio (aHR) = 1.34, 95% CI 0.75-2.40, p = 0.316; high Zva group vs. low Zva group: aHR = 1.17, 95% CI 0.64-2.16, p = 0.613] and cardiovascular mortality (intermediate Zva group vs. low Zva group: aHR = 1.50, 95% CI 0.56-4.06, p = 0.421; high Zva group vs. low Zva group: aHR = 1.25, 95% CI 0.43-3.65, p = 0.682). Our results suggest that post-procedural Zva was not associated with 2-year all-cause or cardiovascular mortalities in patients with severe symptomatic AS who underwent TAVI.

Background: The occurrence and clinical impact of untreated subclinical leaflet thrombosis beyond 1 year after transcatheter aortic valve replacement still remain unclear., Methods and Results: In a multicenter transcatheter aortic valve replacement registry, we analyzed data from 485 patients who underwent 4-dimensional multidetector computed tomography posttranscatheter aortic valve replacement performed to survey hypoattenuated leaflet thickening with reduced leaflet motion compatible with thrombus at a median of 3 days, 6 months, 1 year, 2 years, and 3 years. Incidence, predictors, and clinical outcomes of early (median 3 days) and late (>30 days) leaflet thrombosis were assessed. Additional anticoagulation was not administered because of subclinical findings at the time of computed tomography in all patients. Early leaflet thrombosis occurred in 45 (9.3%) of 485 patients. Mean pressure gradient at discharge was higher in patients with early leaflet thrombosis than in those without. Independent predictors of early leaflet thrombosis in balloon-expandable prostheses were low-flow, low-gradient aortic stenosis, severe prosthesis-patient mismatch, and 29-mm prostheses. No predictors could be identified for self-expanding prosthesis. Cumulative event rates of death, stroke, or rehospitalization for heart failure over 2 years were 10.7% and 16.9% in patients with and without early leaflet thrombosis, respectively ( P=0.63). Late leaflet thrombosis occurred late up to 3 years, and male sex and paravalvular leak less than mild were independent predictors., Conclusions: Untreated early leaflet thrombosis did not affect the cumulative event rates of death, stroke, and rehospitalization for heart failure. Late leaflet thrombosis was newly detected during 3-year follow-up. Visual Overview: A visual overview is available for this article.

Background: Predictors of bleeding and mortality after trans femoral transcatheter aortic valve replacement (TF-TAVR) has not been thoroughly investigated., Objective: The aim of this study was to assess whether Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly, Drugs/alcohol concomitantly (HAS-BLED) score has predictive value for bleeding and mortality in patients after TAVR., Methods: Between October 2013 and April 2016, 969 patients underwent TF-TAVI were prospectively included in the OCEAN-TAVI registry from Japan. The primary outcomes were severe bleeding (including life-threatening and major bleeding defined in The Valve Academic Research Consortium-2 criteria) and mortality within 1 year after TAVR., Results: Elderly (84 ± 5 years) and high surgical risk patients (The Society of Thoracic Surgery Risk Score 6.7 [4.6-9.3]) were enrolled. Severe bleeding and mortality had occurred in 177 patients (18.2%) and 66 patients (6.8%), respectively. On multivariate analysis, HAS-BLED score was associated with severe bleeding (hazard ratio [HR], 1.82; 95% confidence interval [CI], 1.41-2.00; p < 0.001) and mortality (HR, 2.04, 95% CI, 1.56-2.69, P < 0.001). A HAS-BLED score threshold of 4 points (area under the curve 0.71 for severe bleeding, 0.72 for mortality) predicted a higher rate of severe bleeding (25.3% vs. 14.4%, P < 0.001) and mortality (16.2% vs. 4.0%, P < 0.001)., Conclusions: HAS-BLED score could predict the risk of severe bleeding and mortality in patients who underwent TF-TAVR independent of the presence of atrial fibrillation., (© 2018 Wiley Periodicals, Inc.)

Background: The prognostic impact of skeletal muscle mass, assessed using lean body mass (LBM), remain unclear in patients who underwent transcatheter aortic valve replacement (TAVR). The aim of this study to assess prognostic impact of LBM on mortality after TAVR., Methods: We assessed 1,613 patients (median age 85 years, 70% female) who underwent TAVI from October 2013 to April 2016 using OCEAN (Optimized transCathEter vAlvular interveNtion)-TAVI registry data. LBM was calculated using the James formula. The primary endpoint was all-cause death after TAVR., Results: Median follow-up period was 287 days (interquartile range 110-462). The Kaplan-Meier analysis demonstrated that patients with low LBM had significantly higher incidence of all-cause death than those with high LBM in male (32.3% vs. 9.9%, log rank P < 0.001) and female (15.8% vs. 9.2%, log-rank P = 0.011). On contrary, the risk stratification using body mass index (BMI) could not validate into female patients who underwent TAVR. The multivariate analysis showed that the LBM was an independent predictor of all-cause death in male (Hazard ratio [HR] 0.93; 95% confidence interval [CI] 0.89-0.98) and female (HR 0.94; 95% CI 0.89-0.99). Inversely, the assessment using BMI could not identify the high-risk population in a female., Conclusions: The patients with low LBM had the higher incidence of all-cause death after TAVR than those with high LBM, regardless of gender. Thus, the risk stratification using LBM might provide further insight to identify the high-risk TAVR population, compared to conventional risk stratification using BMI., (© 2018 Wiley Periodicals, Inc.)

Background Although transcatheter aortic valve replacement ( TAVR ) is the least invasive treatment for patients with symptomatic aortic stenosis, some patients hesitate to undergo the procedure. We investigated the clinical impact of treatment delay after patient refusal of TAVR . Methods and Results We used the Japanese OCEAN (Optimized Catheter valvular intervention) regsitry data of 1542 patients who underwent TAVR . Refusal was defined as at least 1 refusal of TAVR at the time of informed consent. Patients were separated into 2 groups: refusal (28/1542, 1.8%) and non-refusal (1514/1542, 98.2%). We compared the baseline characteristics, procedural outcomes, and mortality rates between the groups. Additionally, data on reasons for refusal and those leading to eventually undergoing TAVR were collected. Age, surgical risk scores, and frailty were higher in the refusal group than in the non-refusal group ( P<0.05 for all). Periprocedural complications did not differ between groups, whereas 30-day and cumulative 1-year mortality were significantly higher in the refusal group than in the non-refusal group (7.1% versus 1.3%, P=0.008 and 28.8% versus 10.3%, P=0.010, respectively). Multivariate Cox regression analysis revealed that TAVR refusal was an independent predictor of increased midterm mortality (hazard ratio: 3.37; 95% confidence interval: 1.52-7.48; P=0.003). The most common reason for refusal was fear (13/28, 46.4%), and the most common reason for changing their mind was worsening heart failure (21/28, 75.0%). All patients in the refusal group decided to undergo TAVR within 20 months (median: 5.5 months). Conclusions Refusing TAVR even once led to poorer prognosis; therefore, this fact should be clearly discussed when obtaining informed consent.

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., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Objectives: The aim of this study was to investigate the 2-year prognostic impact of N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels at discharge following transcatheter aortic valve implantation (TAVI)., Design: Multicentre prospective observational study., Settings: Seven institutions from multicentre, observational registry of symptomatic patients with severe aortic stenosis who undergo TAVI., Participants: We enrolled 500 consecutive patients who underwent TAVI with measurements of NT-proBNP at discharge between 2013 and 2016. Study patients were stratified into two groups according to survival classification and regression tree (CART) analysis: high versus low NT-proBNP groups., Interventions: The impact of high NT-proBNP on a 2-year composite endpoint consisting of all-cause mortality and heart failure hospitalisation was evaluated using a multivariable Cox model., Results: Median age was 86 years (quartile 82-89), and 24.2% of the study population were men. Median Society of Thoracic Surgeon score was 7.1 (5.1-9.8), and NT-proBNP at discharge was 1381 (653-3136) pg/mL. The composite endpoint incidence was 13.0% (95% CI 9.5% to 16.3%) at 1 year and 22.3% (95% CI 16.1%-27.9%) at 2 years. The survival CART analysis revealed that the NT-proBNP level required to discern the 2-year composite endpoint was 4288 pg/mL. Elevated NT-proBNP had a statistically significant impact on outcomes, with adjusted HR of 2.21 (95% CI 1.21 to 4.04, p=0.010), and with a significant sex difference ( P for interaction=0.003)., Conclusion: Elevation of NT-proBNP at discharge is associated with higher incidence of the 2-year composite endpoint after TAVI., Trial Registration Number: 000020423., Competing Interests: Competing interests: KH, SS, MT, MA, KT and NT are clinical proctors for Edwards Lifesciences. MY, YW and TN are clinical proctors for both Edwards Lifesciences and Medtronic., (© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Nutritional condition is one marker of patients' frailty. The Geriatric Nutritional Risk Index (GNRI) is a well-known marker of nutritional status. This study sought to assess the clinical outcomes of GNRI after transcatheter aortic valve replacement (TAVR)., Methods: We evaluated the GNRI value of 1,613 patients who underwent TAVR using data from a Japanese multicenter registry. According to baseline GNRI, patients were classified into 3 groups: GNRI ≥92 (n = 1,085; 67.3%), GNRI 82-92 (n = 396; 24.6%), and GNRI ≤82 (n = 132; 8.2%). Baseline characteristics, procedural outcomes, and cumulative mortality rates were compared. In addition, GNRI correlations with other frailty components (gait speed, grip strength, and Clinical Frailty Scale) and Society of Thoracic Surgeons (STS) score were also evaluated., Results: Significantly increased mortality rates were observed across the 3 groups at 30 days (0.9%, 2.3%, and 6.8%, respectively; P < .001) and 1 year (6.5%, 16.4%, and 36.4%, respectively; P < .001). Both GNRI 82-92 and GNRI ≤82 (as a reference for GNRI ≥92) were independently associated with increased midterm mortality in the Cox regression multivariate model (hazard ratio: 1.97, 3.60; 95% confidence interval: 1.37-2.84, 2.30-5.64; P < .001, P < .001, respectively). The GNRI value was significantly correlated with gait speed (Spearman ρ = -0.15, P < .001), grip strength (ρ = 0.25, P < .001), Clinical Frailty Scale (ρ = -0.24, P < .001), and STS score (ρ = -0.29, P < .001)., Conclusions: GNRI is related to both frailty components and the STS score and is an important surrogate marker for predicting worse clinical outcomes after TAVR. Assessment of the GNRI may be considered when deciding on TAVR., (Copyright © 2018. Published by Elsevier Inc.)

Background: Hyponatremia is associated with the increased risk of early and late mortality in patients with cardiac disease. This study aimed to assess the prognostic value of hyponatremia in patients who had undergone transcatheter aortic valve replacement (TAVR)., Methods: We investigated 1,215 consecutive patients (mean age: 84.4 ± 5.0 years) who underwent TAVR using data from the Optimized CathEter vAlvular iNtervention (OCEAN)-TAVR Japanese multicenter registry. Hyponatremia was defined as a serum sodium value less than 135 mEq/L. The baseline characteristics, procedural outcomes, all-cause, cardiovascular, and non-cardiovascular mortality were compared between patients with hyponatremia (n = 106, 8.7%) and without hyponatremia (n = 1,109, 91.3%). A propensity-matching analysis was used to adjust for the non-uniform patient characteristics., Results: Differences in the baseline characteristics were observed between the two groups regarding the prevalence of pulmonary disease (37.7% vs. 28.9%, P = 0.04) and the performance of non-elective TAVR (10.4% vs. 4.2%, P = 0.01), although these were minimized in the matched model. The 30-day mortality rates differed between the two groups (7.6% vs. 1.4%, P < 0.001). During a mean follow-up of 330 days, the all-cause and cardiovascular mid-term mortality were higher in the hyponatremia group than in the non-hyponatremia group (log-rank test: P = 0.0047, and P < 0.001, respectively). The three findings above were not attenuated in the propensity-matched model (P < 0.001, P = 0.0044, and P = 0.014, respectively). In contrast, there was no difference in non-cardiovascular mortality between the two groups in both the overall and matched model (P = 0.40 and P = 0.13, respectively)., Conclusions: Pre-procedural hyponatremia may be a useful marker for predicting early and mid-term clinical outcomes after TAVR., (© 2018 Wiley Periodicals, Inc.)

The relation between C-reactive protein (CRP) level on admission and mortality after transcatheter aortic valve implantation (TAVI) remains unclear. To evaluate the impact of serum CRP level on mortality after TAVI, we assessed 1,016 patients with CRP who underwent TAVI and 538 patients with high-sensitive CRP (hs-CRP) level who underwent TAVI on admission in the OCEAN (Optimized Transcatheter Valvular Intervention)-TAVI registry. Study population was stratified into 2 groups (high/low), according to the median of CRP and hs-CRP on admission. We assessed the impact of high CRP and hs-CRP level on all-cause death after TAVI. During 2-year follow-up, all-cause death after TAVI was 9.4% in patients with CRP and 11.9% in patients with hs-CRP. Median value of serum CRP was 0.10 mg/dl in both CRP and hs-CRP. Patients with high CRP (>0.10 mg/dl) had significantly higher incidence of all-cause death compared with those with low CRP (11.5% vs 7.6%, log-rank p = 0.015). Multivariate Cox regression analysis with a time-varying covariate demonstrated that high CRP was an independent predictor of all-cause death within the first 3 months (hazard ratio 2.78, 95% CI 1.30 to 5.95) compared with from 3 months to 2 years (hazard ratio 0.80, 95% CI 0.47 to 1.36) (P for interaction = 0.008). Inversely, these results were not observed in the stratification using hs-CRP on admission. In conclusion, high CRP on admission was significantly associated with an increased risk of all-cause death after TAVI, particularly within the first 3 months after TAVI. Risk stratification using CRP may be a simple and useful strategy to identify high-risk patients who undergo TAVI., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Objectives: This study aimed to analyze the prognostic impact of low-flow (LF) severe aortic stenosis in small-body patients undergoing transcatheter aortic valve replacement (TAVR)., Background: Western literature demonstrates a poor prognosis with paradoxical LF and low-flow low-gradient (LF-LG) severe aortic stenosis (AS), as defined by stroke volume index (SVi) <35 ml/m 2 and mean pressure gradient <40 mm Hg with preserved left ventricular ejection fraction (LVEF). However, this poor prognosis is contested in Japan owing to the smaller body size of Japanese patients relative to that of Western patients. Additionally, there are no reports of the prognostic implication of paradoxical LF or LF-LG severe AS in small-body patients undergoing TAVR., Methods: This was a retrospective analysis of 723 consecutive Japanese patients (median age 85 years; 32.6% male; median body surface area 1.4 m 2 ) who underwent TAVR for severe AS at 9 sites in Japan. The primary and secondary endpoints were cumulative all-cause and cardiovascular mortality after TAVR, respectively., Results: Ninety-seven (13.4%) patients had paradoxical LF severe AS whereas 38 (5.3%) had paradoxical LF-LG with severe AS. PLF was associated with a significant increase in all-cause (hazard ratio [HR]: 3.00; 95% confidence interval [CI]: 1.34 to 6.72; p < 0.001) and cardiovascular mortality (HR: 5.58; 95% CI: 1.19 to 26.2; p < 0.01), as compared with patients' normal flow and preserved LVEF. PLF-LG was associated with a significant increase in all-cause mortality (HR: 3.76; 95% CI: 1.09 to 13.73; p < 0.01), as compared with normal flow high gradient with preserved LVEF. SVi was an independent predictor of cardiovascular mortality on multivariate analysis after adjustments for age, sex, clinically relevant variables, and other echocardiographic parameters (HR: 1.96; 95% CI: 1.19 to 3.23; p < 0.01)., Conclusions: Among Japanese small-body patients with severe AS, both paradoxical LF and LF-LG severe AS were associated with poor outcomes following TAVR. SVi was an independent predictor of cardiovascular mortality after TAVR. (Optimised Transcatheter Valvular Intervention registry [OCEAN-TAVI]; UMIN000020423)., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Objectives: The authors sought to investigate the prevalence, risk factors, and mid-term mortality in Asian patients with prosthesis-patient mismatch (PPM) after transcatheter aortic valve replacement (TAVR)., Background: Little information is available on PPM after TAVR in Asian patients., Methods: The authors included 1,558 patients enrolled in the OCEAN-TAVI (Optimized transCathEter vAlvular iNtervention) Japanese multicenter registry from October 2013 to July 2016 after excluding patients who died following TAVR before discharge. PPM was defined as moderate if ≧0.65 but ≦0.85 cm 2 /m 2 , or severe if <0.65 cm 2 /m 2 at the indexed effective orifice area by post-procedural echocardiography., Results: Of the 1,546 patients, moderate and severe PPM were observed in 138 (8.9%) and 11 (0.7%) patients, respectively. These 149 patients were included in the PPM group. The median age and body surface area were 85 years (interquartile range [IQR]: 81 to 88 years) and 1.41 m 2 (IQR: 1.30 to 1.53 m 2 ), respectively. In our multivariate analysis, younger age, larger body surface area, smaller aortic valve area, smaller annulus area, no balloon post-dilatation, and use of Edwards Sapien 3 (Edwards Lifesciences, Irvine, California) were identified as independent predictors of PPM. The estimated cumulative all-cause mortality at 1 year using the Kaplan-Meier method was similar between the PPM and non-PPM groups (10.2% vs. 8.3%; log-rank; p = 0.41)., Conclusions: The low prevalence of PPM and mortality at 1 year in patients with PPM after TAVR in this Japanese cohort implies that PPM is not a risk factor for mid-term mortality in Asian patients who have undergone TAVR., (Copyright © 2018 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Aims: The aim of this study was to compare incidences of radial artery occlusion (RAO) and spasm (RAS) associated with transradial coronary intervention (TRI) using a 6.5 Fr SheathLess hydrophilic-coated guide catheter (SH-GC) vs. a 6.0 Fr Glidesheath Slender (GSS)., Methods and Results: We conducted an open-label, single-centre, randomised study to compare radial complications in 600 consecutive patients undergoing elective TRI using 6.5 Fr SH-GC (n=300) or 6.0 Fr GSS (n=300) between 2015 and 2016. The primary endpoint was a composite of RAO evaluated by sonography and symptomatic RAS. The mean diameter of radial arteries was 2.20 mm in both groups; however, the sheath/radial artery diameter (S/RA) ratio was significantly smaller in the SH-GC group (1.03 vs. 1.17, p<0.001). SH-GC was associated with a higher rate of system crossover (1.7% vs. 0.7%, p=0.450) and coronary ostial dissection (1.0% vs. 0.3%, p=0.624), although there were no statistically significant differences. The incidence of major adverse cardiac events was comparable. A lower incidence of RAO and access-site crossover owing to RAS was significantly associated with SH-GC (0.0% vs. 2.0%, p=0.031). Multivariate analysis revealed that a larger S/RA ratio predicted RAO and RAS independently (p=0.007)., Conclusions: The 6.5 Fr SH-GC offers a promising alternative to conventional TRI and is associated with fewer radial complications than the 6.0 Fr GSS.

Objective: The persistence of left ventricular (LV) hypertrophy is associated with poor clinical outcomes after transcatheter aortic valve implantation (TAVI) for aortic stenosis. However, the optimal medical therapy after TAVI remains unknown. We investigated the effect of renin-angiotensin system (RAS) blockade therapy on LV hypertrophy and mortality in patients undergoing TAVI., Methods: Between October 2013 and April 2016, 1215 patients undergoing TAVI were prospectively enrolled in the Optimized CathEter vAlvular iNtervention (OCEAN)-TAVI registry. This cohort was stratified according to the postoperative usage of RAS blockade therapy with angiotensin-converting enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARBs). Patients with at least two prescriptions dispensed 180 days apart after TAVI and at least a 6-month follow-up constituted the RAS blockade group (n=371), while those not prescribed any ACE inhibitors or ARBs after TAVI were included in the no RAS blockade group (n=189)., Results: At 6 months postoperatively, the RAS blockade group had significantly greater LV mass index regression than the no RAS blockade group (-9±24% vs -2±25%, p=0.024). Kaplan-Meier analysis revealed a significantly lower cumulative 2-year mortality in the RAS blockade than that in the no RAS blockade group (7.5% vs 12.5%; log-rank test, p=0.031). After adjusting for confounding factors, RAS blockade therapy was associated with significantly lower all-cause mortality (HR, 0.45; 95% CI 0.22 to 0.91; p=0.025)., Conclusions: Postoperative RAS blockade therapy is associated with greater LV mass index regression and reduced all-cause mortality. These data need to be confirmed by a prospective randomised controlled outcome trial., Competing Interests: Competing interests: Drs SS, MY, NT, TN, MA, SS, YW and KH are proctors for Edwards Lifesciences (transfemoral-TAVI with SAPIEN-XT valves)., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Objectives: Favourable results have been reported for monitored anaesthesia care that includes local anaesthesia and conscious sedation [minimalist approach (MA)] for transfemoral transcatheter aortic valve replacement (TAVR). However, the efficacy of MA is still controversial in Japan. We describe our experience from a Japanese multicentre registry., Methods: Between October 2013 and April 2016, 1215 consecutive Japanese patients with symptomatic, severe aortic stenosis undergoing TAVR with self-expandable or balloon-expandable valves were prospectively included in the Optimized transCathEter vAlvular intervention-Transcatheter Aortic Valve Implantation (OCEAN-TAVI) registry. Of these patients, we retrospectively reviewed 921 consecutive patients who underwent elective transfemoral-TAVR. We evaluated the perioperative results of MA-TAVR and non-minimalist approach (NMA) TAVR using propensity score matching analysis., Results: A total of 118 patients underwent MA-TAVR, and 802 patients underwent NMA-TAVR [median age 84 vs 85 years, P = 0.25; Society of Thoracic Surgeons (STS) score 7.6 vs 6.4, P = 0.01]. One hundred eighteen matched pairs were compared after propensity score matching. In-hospital mortality and stroke/transient ischaemic attack were not significantly different between the MA-TAVR and the NMA-TAVR groups (2.5% vs 0.8%, P = 0.3; 1.7% vs 0.8%, P = 0.6, respectively). Major or life-threatening bleeding and the transfusion rate were significantly lower in the MA-TAVR group (3.4% vs 17%, P = 0.003; 6.8% vs 29%, P = 0.0002, respectively). The total intensive care unit days and length of hospital stay were significantly lower in the MA-TAVR group (P ≤ 0.0002)., Conclusions: MA-TAVR has similar results to NMA-TAVR in terms of mortality and stroke in this Japanese multicentre registry. Shorter procedure time and hospital stays were seen in the MA-TAVR group. MA-TAVR is as safe and effective as NMA-TAVR., (© The Author 2017. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.)

Aim: Small intestine-derived chylomicrons and chylomicron remnants, which are predominant in patients with postprandial hypertriglyceridemia, chylomicron syndrome and/or familial dyslipidemia, carry one molecule of apolipoprotein B-48(apo B-48) per lipoprotein particle. We investigated the reference interval for the apo B-48 concentration., Methods: We studied 516 individuals who provided written informed consent and confirmed that they were not taking any medications. BMI, waist circumference, blood pressure and the fasting serum concentrations of LDL-C, triglyceride(TG), HDL-C and apo B-48 were measured. The Apo B-48 concentrations were compared according to sex, a pre- or postmenopausal status, dyslipidemia(LDL-C ≥140 mg/dL, TG ≥150 mg/dL, HDL-C ＜40 mg/dL), metabolic syndrome(MetS) and the number of risk factors., Results: The fasting apo B-48 concentrations(mean±SD) were significantly higher in men than in women(3.8±3.3 μg/mL vs 2.4±1.9 μg/mL, p＜0.001), subjects with a BMI of ≥25 kg/m(2) versus a BMI of ＜25 kg/m(2) (4.4±3.7 μg/mL vs 2.8±2.4 μg/mL, p＜0.001) and those with versus without MetS(6.5±4.3 μg/mL vs 3.0±2.6 μg/mL, p＜0.001). High apo B-48 concentrations were also observed in correlation with the number of risk factors for the MetS. The upper reference limit of apo B-48 was estimated to be 5.7 μg/mL among the 332 patients with normolipidemia, excluding those exhibiting a mean value above ±2.58 standard deviations(SDs), as the mean and range of mean ±1.96 SD were calculated to be 2.04 μg/mL(reference value) and 0.74 to 5.65 μg/mL(reference interval), respectively., Conclusions: Based on our study of normolipidemic patients, the upper reference limit for the fasting apo B-48 concentration is estimated to be 5.7 μg/mL.

A 77-year-old woman underwent percutaneous closure of post-infarction ventricular septal defect. The defect was successfully closed with a 20-mm Amplatzer septal occluder with a small residual shunt and Qp/Qs improved from 3.38 to 1.48. She was discharged 30 days after procedure. To our knowledge, this is the first case reported in Japan.

Background: Remnant lipoprotein (RLP), associated with atherosclerosis progression, is often elevated in diabetes mellitus. The RLP level is estimated by immune-separation method and agarose-gel electrophoresis (AGE)., Methods: The patients were grouped into three groups according to tertile of RLP-cholesterol (RLP-C) levels. The lipoprotein profiles of type II diabetic patients (T2DM) (n=194) were measured by an anion-exchange liquid chromatography (AEX-HPLC) and an AGE with lipid-staining or cholesterol-staining., Results: IDL- and VLDL-cholesterol by the AEX-HPLC, and VLDL-levels by the AGE with lipid-staining and with cholesterol-staining were significantly different in the three groups. In all the subjects, IDL-cholesterol (r=0.531) and VLDL-cholesterol (r=0.880) by the AEX-HPLC method were strongly correlated with RLP-C, but only VLDL levels were correlated with RLP-C in AGE, respectively., Conclusion: These results suggest that the AEX-HPLC, which can provide cholesterol levels of not only VLDL but also IDL, is helpful for estimation of lipid profiles in T2DM with high RLP-C., (Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.)

According to many prospective cohort studies and meta-analyses of those studies, physical inactivity and/or low levels of physical fitness are associated with an elevated risk for the development of metabolic syndrome, type 2 diabetes, hypertension, coronary artery disease (CAD), and stroke, and with an increased risk of cardiovascular disease (CVD) mortality and all-cause mortality. Most of these analyses, however, were conducted on non-Japanese populations in the West. This report summarizes prospective observational and clinical studies in Japan. The annual national nutrition survey has shown a gradual decline in the number of walking steps in both genders and in all age groups over the last 10 years. While exercise habits have been gradually increasing in the elderly, only one-fifth of young and middle-aged people undertake leisure-time physical activity. Prospective cohort studies have shown that increased physical fitness and greater physical activity in either daily life or leisure time are of benefit in preventing all-cause mortality and CVD mortality. The daily number of walking steps is positively associated with HDL cholesterol levels and negatively associated with triglyceride levels. According to a random-effects model meta-analysis of 4 randomized controlled trials comparing supervised aerobic exercise training with non-exercise control in subjects without CAD, exercise resulted in a significant increase in HDL-cholesterol (10.01 mg/dL, 95% CI 5.38 to 14.65, p< 0.0001). While this confirms the importance of physical activity in preventing CVD mortality and all-cause mortality, the levels of physical activity are on a declining trend in Japan, particularly among the young.

To demonstrate the reasons for low morbidity and mortality from coronary artery disease (CAD) and reconfirm the effectiveness of the Japanese dietary lifestyle for preventing CAD, we herein review the CAD risk transition, and post-war changes in Japanese food and nutrient intake. Large-scale cohort studies in Japan were selectively reviewed. Low serum total cholesterol contributed to preventing CAD, and decreased blood pressure was the major factor favoring stroke reduction. Japanese consumed more plant and marine origin foods, but fewer animal foods with saturated fatty acids (SFA) during the 1960-70s than in recent decades. Adequate control of total energy with restriction of saturated fatty acids from animal foods, increased intake of n-3 polyunsaturated fatty acids, including fish, soybean products, fruits and vegetables together with low salt intake are responsible for promoting CAD and stroke prevention. A diet with adequate total calories and increased intake of fish and plant foods, but decreased intake of refined carbohydrates and animal fat, a so-called Japan diet, appears to be quite effective for prevention of CAD risk factors and is recommended as dietary therapy for preventing CAD.

To find out clues to differentiate between polymyalgia rheumatica (PMR) and other diseases that mimic PMR. We studied Japanese patients with PMR (n = 7), pseudogout (n = 1), remitting seronegative symmetrical synovitis with pitting edema (RS3PE) syndrome (n = 1), and post-infectious polyarthritis (n = 1). The distribution of inflammation in patients was evaluated using a gallium-67 scintigraphy. We measured serum C-reactive protein (CRP), matrix metalloproteinase-3 (MMP-3), and vascular endothelial growth factor (VEGF) in patients before and after treatment. Further, we compared the clinical course of PMR with that of other diseases that mimic PMR. Patients with pseudogout, RS3PE syndrome, post-infectious polyarthritis manifested similar changes in scintigraphic findings and serum CRP, MMP-3, and VEGF levels to PMR before the treatment. A significant reduction in serum CRP levels at one week after use of nonsteroidal anti-inflammatory drugs (NSAIDs) is a good clue to differentiate pseudogout and post-infectious polyarthritis from PMR. Chondrocalcinosis in the radiographs of joints is also effective to differentiate pseudogout from PMR. A small reduction of CRP levels after NSAIDs use and promptly ameliorated CRP and symptoms by a low-dose steroid therapy, which was commonly observed in patients with PMR, were also found in a patient with RS3PE syndrome. Pitting edema of the back of hands and gallium uptake in metacarpophalangeal (MCP) joints were useful to differentiate RS3PE syndrome from PMR. In conclusion, pseudogout, RS3PE syndrome, post-infectious polyarthritis should be included in the spectrum of diseases mimicking PMR. A promptly decreased serum CRP level by NSAIDs is a good clue to differentiate pseudogout and post-infectious polyarthritis from PMR. Pitting edema of the back of hands and symmetric gallium uptake in MCP joints are characteristic for RS3PE syndrome.