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  • Ovid Technologies (Wolters Kluwer Health)  (7)
  • Tada, Norio  (7)
  • 1
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    Online Resource
    Prognostic Value of Ventricular‐Arterial Coupling After Transcatheter Aortic Valve Replacement on Midterm Clinical Outcomes
    Ovid Technologies (Wolters Kluwer Health) ; 2021
    In:  Journal of the American Heart Association Vol. 10, No. 18 ( 2021-09-21)
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    In: Journal of the American Heart Association, Ovid Technologies (Wolters Kluwer Health), Vol. 10, No. 18 ( 2021-09-21)
    Abstract: 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: 〈 0.326; group 2: 0.326–0.453; group 3: 0.453–0.666; and group 4: 〉 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 〈 0.001]), and group 4 (HR, 2.89; 95% CI, 1.83–4.57 [ P 〈 0.001]) than that in group 1. On adjusted multivariable Cox analysis, Ea/Ees was significantly associated with composite events (HR, 1.47 per 1‐unit increase; 95% CI, 1.08–2.01 [ 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.
    Type of Medium: Online Resource
    ISSN: 2047-9980
    URL: Article
    DOI: 10.1161/JAHA.120.019267
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2021
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  • 2
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    Appropriateness of Transcatheter Aortic Valve Replacement : Insight From the OCEAN-TAVI Registry
    Ovid Technologies (Wolters Kluwer Health) ; 2020
    In:  Circulation: Cardiovascular Quality and Outcomes Vol. 13, No. 4 ( 2020-04)
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    In: Circulation: Cardiovascular Quality and Outcomes, Ovid Technologies (Wolters Kluwer Health), Vol. 13, No. 4 ( 2020-04)
    Abstract: 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.
    Type of Medium: Online Resource
    ISSN: 1941-7713 , 1941-7705
    URL: Article
    DOI: 10.1161/CIRCOUTCOMES.119.006146
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2020
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  • 3
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    Early and Late Leaflet Thrombosis After Transcatheter Aortic Valve Replacement : A Multicenter Initiative From the OCEAN-TAVI Registry
    Ovid Technologies (Wolters Kluwer Health) ; 2019
    In:  Circulation: Cardiovascular Interventions Vol. 12, No. 2 ( 2019-02)
    Details
    In: Circulation: Cardiovascular Interventions, Ovid Technologies (Wolters Kluwer Health), Vol. 12, No. 2 ( 2019-02)
    Abstract: 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.
    Type of Medium: Online Resource
    ISSN: 1941-7640 , 1941-7632
    URL: Article
    DOI: 10.1161/CIRCINTERVENTIONS.118.007349
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2019
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  • 4
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    Impact of the Clinical Frailty Scale on Outcomes After Transcatheter Aortic Valve Replacement
    Ovid Technologies (Wolters Kluwer Health) ; 2017
    In:  Circulation Vol. 135, No. 21 ( 2017-05-23), p. 2013-2024
    Details
    In: Circulation, Ovid Technologies (Wolters Kluwer Health), Vol. 135, No. 21 ( 2017-05-23), p. 2013-2024
    Abstract: The semiquantitative Clinical Frailty Scale (CFS) is a simple tool to assess patients’ frailty and has been shown to correlate with mortality in elderly patients even when evaluated by nongeriatricians. The aim of the current study was to determine the prognostic value of CFS in patients who underwent transcatheter aortic valve replacement. Methods: We utilized the OCEAN (Optimized Catheter Valvular Intervention) Japanese multicenter registry to review data of 1215 patients who underwent transcatheter aortic valve replacement. Patients were categorized into 5 groups based on the CFS stages: CFS 1-3, CFS 4, CFS 5, CFS 6, and CFS ≥7. We subsequently evaluated the relationship between CFS grading and other indicators of frailty, including body mass index, serum albumin, gait speed, and mean hand grip. We also assessed differences in baseline characteristics, procedural outcomes, and early and midterm mortality among the 5 groups. Results: Patient distribution into the 5 CFS groups was as follows: 38.0% (CFS 1-3), 32.9% (CFS4), 15.1% (CFS 5), 10.0% (CFS 6), and 4.0% (CFS ≥7). The CFS grade showed significant correlation with body mass index (Spearman’s ρ=−0.077, P =0.007), albumin (ρ=−0.22, P 〈 0.001), gait speed (ρ=−0.28, P 〈 0.001), and grip strength (ρ=−0.26, P 〈 0.001). Cumulative 1-year mortality increased with increasing CFS stage (7.2%, 8.6%. 15.7%, 16.9%, 44.1%, P 〈 0.001). In a Cox regression multivariate analysis, the CFS (per 1 category increase) was an independent predictive factor of increased late cumulative mortality risk (hazard ratio, 1.28; 95% confidence interval, 1.10–1.49; P 〈 0.001). Conclusions: In addition to reflecting the degree of frailty, the CFS was a useful marker for predicting late mortality in an elderly transcatheter aortic valve replacement cohort.
    Type of Medium: Online Resource
    ISSN: 0009-7322 , 1524-4539
    URL: Article
    DOI: 10.1161/CIRCULATIONAHA.116.025630
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2017
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  • 5
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    Small Left Ventricle and Clinical Outcomes After Transcatheter Aortic Valve Replacement
    Ovid Technologies (Wolters Kluwer Health) ; 2021
    In:  Journal of the American Heart Association Vol. 10, No. 7 ( 2021-04-06)
    Details
    In: Journal of the American Heart Association, Ovid Technologies (Wolters Kluwer Health), Vol. 10, No. 7 ( 2021-04-06)
    Abstract: 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 〈 42.0 mm for men or 〈 37.8 mm for women. The 2‐year clinical outcomes were compared between patients with and without small LV using multivariable Cox regression analyses and propensity score matching. Subgroup analyses by LF, left ventricular hypertrophy were performed. Of 2584 patients who underwent TAVR, 466 (18.0%) had small LV. Patients with small LV had smaller body size and less comorbidity, and were more likely to have LF status compared with those without. Small LV was associated with a higher 2‐year all‐cause (20.8% versus 14.3%; adjusted hazard ratio [HR],1.58 [95% CI, 1.20–2.09] ; 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.
    Type of Medium: Online Resource
    ISSN: 2047-9980
    URL: Article
    DOI: 10.1161/JAHA.120.019543
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2021
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  • 6
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    Aspirin Versus Clopidogrel as Single Antithrombotic Therapy After Transcatheter Aortic Valve Replacement: Insight From the OCEAN-TAVI Registry
    Ovid Technologies (Wolters Kluwer Health) ; 2021
    In:  Circulation: Cardiovascular Interventions Vol. 14, No. 5 ( 2021-05)
    Details
    In: Circulation: Cardiovascular Interventions, Ovid Technologies (Wolters Kluwer Health), Vol. 14, No. 5 ( 2021-05)
    Abstract: 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.
    Type of Medium: Online Resource
    ISSN: 1941-7640 , 1941-7632
    URL: Article
    DOI: 10.1161/CIRCINTERVENTIONS.120.010097
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2021
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  • 7
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    Patients Refusing Transcatheter Aortic Valve Replacement Even Once Have Poorer Clinical Outcomes
    Ovid Technologies (Wolters Kluwer Health) ; 2018
    In:  Journal of the American Heart Association Vol. 7, No. 18 ( 2018-09-18)
    Details
    In: Journal of the American Heart Association, Ovid Technologies (Wolters Kluwer Health), Vol. 7, No. 18 ( 2018-09-18)
    Abstract: 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.
    Type of Medium: Online Resource
    ISSN: 2047-9980
    URL: Article
    DOI: 10.1161/JAHA.118.009195
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2018
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