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  • 1
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    Is elevation of N-terminal pro-B-type natriuretic peptide at discharge associated with 2-year composite endpoint of all-cause mortality and heart failure hospitalisation after transcatheter aortic valve implantation? Insights from a multicentre prospective OCEAN-TAVI registry in Japan
    BMJ ; 2018
    In:  BMJ Open Vol. 8, No. 8 ( 2018-08), p. e021468-
    Details
    In: BMJ Open, BMJ, Vol. 8, No. 8 ( 2018-08), p. e021468-
    Abstract: 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
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    DOI: 10.1136/bmjopen-2017-021468
    Language: English
    Publisher: BMJ
    Publication Date: 2018
    detail.hit.zdb_id: 2599832-8
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  • 2
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    Predictors and clinical outcomes of poor symptomatic improvement after transcatheter aortic valve replacement
    BMJ ; 2021
    In:  Open Heart Vol. 8, No. 2 ( 2021-11), p. e001742-
    Details
    In: Open Heart, BMJ, Vol. 8, No. 2 ( 2021-11), p. e001742-
    Abstract: 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).
    Type of Medium: Online Resource
    ISSN: 2053-3624
    URL: Article
    DOI: 10.1136/openhrt-2021-001742
    Language: English
    Publisher: BMJ
    Publication Date: 2021
    detail.hit.zdb_id: 2747269-3
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  • 3
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    Impact of beta blockers on patients undergoing transcatheter aortic valve replacement: the OCEAN-TAVI registry
    BMJ ; 2020
    In:  Open Heart Vol. 7, No. 2 ( 2020-07), p. e001269-
    Details
    In: Open Heart, BMJ, Vol. 7, No. 2 ( 2020-07), p. e001269-
    Abstract: There is paucity of data on optimal medical treatment, including use of beta blockers for patients undergoing transcatheter aortic valve replacement (TAVR). The study aimed to investigate the association of beta blockers and clinical outcomes following TAVR. Methods We examined data of 2563 patients who underwent TAVR between October 2013 and May 2017 obtained from a prospective multicentre cohort registry, the optimised catheter valvular intervention-TAVI registry. We compared the 2-year cardiovascular and non-cardiovascular mortality and in-hospital outcomes between patients with and without preprocedural beta-blocker administration by propensity score matching (PSM). Results Preprocedural beta blockers were prescribed in 867 patients (33.8%). After PSM, the incidence of in-hospital congestive heart failure was significantly lower in patients with preprocedural beta blocker (p=0.046). No differences were found in 2-year cardiovascular and non-cardiovascular mortality. In the subgroup analyses, beta-blocker administration was associated with a lower cardiovascular mortality within 2 years in patients with a history of coronary artery bypass grafting (CABG; log-rank p=0.017), presence of peripheral artery disease (PAD; log-rank p=0.003) and brain natriuretic peptide (BNP) ≥400 pg/mL (log-rank p=0.003). When stratified by postprocedural left ventricular ejection fraction (post-LVEF), beta-blocker administration was associated with a lower cardiovascular mortality among patients with post-LVEF 〈 50% (log-rank p=0.024). Conclusions Preprocedural beta-blocker administration was not associated with 2-year cardiovascular and non-cardiovascular mortality in overall, but was associated with a lower 2-year cardiovascular mortality in patients with a history of CABG, presence of PAD, BNP ≥400 pg/mL and post-LVEF 〈 50%. The findings must be validated using randomised trials.
    Type of Medium: Online Resource
    ISSN: 2053-3624
    URL: Article
    DOI: 10.1136/openhrt-2020-001269
    Language: English
    Publisher: BMJ
    Publication Date: 2020
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  • 4
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    Prognostic impact of postprocedure stroke volume in patients with low-gradient aortic stenosis
    BMJ ; 2019
    In:  Open Heart Vol. 6, No. 1 ( 2019-05), p. e000988-
    Details
    In: Open Heart, BMJ, Vol. 6, No. 1 ( 2019-05), p. e000988-
    Abstract: The effect of postoperative blood flow status on the prognosis of patients with low-gradient severe aortic stenosis (AS) has not been examined. Severe AS is associated with a higher mortality rate after transcatheter aortic valve implantation (TAVI). We examined the prognostic value of low-flow status by comparing stroke volume indices (SVi) before and after TAVI in patients with symptomatic, low-gradient severe AS. Methods A total of 1613 patients with severe symptomatic AS who underwent TAVI in 14 Japanese institutes for low-gradient severe AS (418 patients, median age 84 years, 32.5% men) were prospectively enrolled. The primary endpoint was cardiovascular mortality during follow-up after TAVI, and independent predictors were evaluated. Receiver operating characteristic curves were generated to determine the optimal cut-off value of post-TAVI SVi for predicting cardiovascular mortality, and the receiver operating characteristic curves of pre-TAVI and post-TAVI SVi were compared. Results The cardiovascular mortality rate was 4.1% (17 patients) during follow-up (median 9.2 months). Multivariate analysis revealed post-TAVI SVi to be an independent predictor of cardiovascular mortality (per 10 mL/m 2 decrease; HR, 2.0; 95% CI 1.28 to 3.12). The optimal cut-off value of post-TAVI SVi was 41.4 mL/m 2 . Post-TAVI SVi showed significantly larger area under the curve than pre-TAVI SVi (0.74 (95% CI 0.69 to 0.79) vs 0.61 (95% CI 0.56 to 0.65), p 〈 0.05). Conclusions Post-TAVI SVi is a better predictor of cardiovascular mortality than pre-TAVI SVi in patients with symptomatic low-gradient severe AS. Low-flow and low-normal-flow status (35≤ SVi 〈 40 mL/m 2 ) require careful management after TAVI.
    Type of Medium: Online Resource
    ISSN: 2053-3624
    URL: Article
    DOI: 10.1136/openhrt-2018-000988
    Language: English
    Publisher: BMJ
    Publication Date: 2019
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  • 5
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    Statin therapy for patients with aortic stenosis who underwent transcatheter aortic valve implantation: a report from a Japanese multicentre registry
    BMJ ; 2021
    In:  BMJ Open Vol. 11, No. 6 ( 2021-06), p. e044319-
    Details
    In: BMJ Open, BMJ, Vol. 11, No. 6 ( 2021-06), p. e044319-
    Abstract: 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.
    Type of Medium: Online Resource
    ISSN: 2044-6055 , 2044-6055
    URL: Article
    DOI: 10.1136/bmjopen-2020-044319
    Language: English
    Publisher: BMJ
    Publication Date: 2021
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  • 6
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    A comparison of the resection rate for cold and hot snare polypectomy for 4–9 mm colorectal polyps: a multicentre randomised controlled trial (CRESCENT study)
    BMJ ; 2018
    In:  Gut Vol. 67, No. 11 ( 2018-11), p. 1950-1957
    Details
    In: Gut, BMJ, Vol. 67, No. 11 ( 2018-11), p. 1950-1957
    Abstract: To investigate the success rate of cold snare polypectomy (CSP) for complete resection of 4–9 mm colorectal adenomatous polyps compared with that of hot snare polypectomy (HSP). Design A prospective, multicentre, randomised controlled, parallel, non-inferiority trial conducted in 12 Japanese endoscopy units. Endoscopically diagnosed sessile adenomatous polyps, 4–9 mm in size, were randomly assigned to the CSP or HSP group. After complete removal of the polyp using the allocated technique, biopsy specimens from the resection margin after polypectomy were obtained. The primary endpoint was the complete resection rate, defined as no evidence of adenomatous tissue in the biopsied specimens, among all pathologically confirmed adenomatous polyps. Results A total of 796 eligible polyps were detected in 538 of 912 patients screened for eligibility between September 2015 and August 2016. The complete resection rate for CSP was 98.2% compared with 97.4% for HSP. The non-inferiority of CSP for complete resection compared with HSP was confirmed by the +0.8% (90% CI −1.0 to 2.7) complete resection rate (non-inferiority p 〈 0.0001). Postoperative bleeding requiring endoscopic haemostasis occurred only in the HSP group (0.5%, 2 of 402 polyps). Conclusions The complete resection rate for CSP is not inferior to that for HSP. CSP can be one of the standard techniques for 4–9 mm colorectal polyps. (Study registration: UMIN000018328)
    Type of Medium: Online Resource
    ISSN: 0017-5749 , 1468-3288
    URL: Article
    URL: Article
    DOI: 10.1136/gutjnl-2017-314215
    DOI: 10.1136/gutjnl-2017-314215.supp1
    RVK:
    XA 10000
    Language: English
    Publisher: BMJ
    Publication Date: 2018
    detail.hit.zdb_id: 1492637-4
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  • 7
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    Patients’ characteristics and mortality in urgent/emergent/salvage transcatheter aortic valve replacement: insight from the OCEAN-TAVI registry
    BMJ ; 2020
    In:  Open Heart Vol. 7, No. 2 ( 2020-12), p. e001467-
    Details
    In: Open Heart, BMJ, Vol. 7, No. 2 ( 2020-12), p. e001467-
    Abstract: 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.
    Type of Medium: Online Resource
    ISSN: 2053-3624
    URL: Article
    DOI: 10.1136/openhrt-2020-001467
    Language: English
    Publisher: BMJ
    Publication Date: 2020
    detail.hit.zdb_id: 2747269-3
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  • 8
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    Midterm outcomes of transcatheter aortic valve replacement in patients with active cancer
    BMJ ; 2024
    In:  Open Heart Vol. 11, No. 1 ( 2024-02), p. e002573-
    Details
    In: Open Heart, BMJ, Vol. 11, No. 1 ( 2024-02), p. e002573-
    Abstract: The clinical outcomes of transcatheter aortic valve replacement (TAVR) in patients with aortic stenosis (AS) and concomitant active cancer remain insufficiently explored. This study aimed to assess the midterm outcomes of TAVR in patients diagnosed with AS and active cancer. Methods Data from the OCEAN-TAVI, a prospective Japanese registry of TAVR procedures, was analysed to compare prognoses and clinical outcomes in patients with and without active cancer at the time of TAVR. Results Of the 2336 patients who underwent TAVR from October 2013 to July 2017, 89 patients (3.8%) had active cancer, whereas 2247 did not. Among patients with active cancer, 49 had limited-stage cancer (stage 1 or 2). The prevalent cancers identified before TAVR were colon (21%), prostate (18%), lung (15%), liver (11%) and breast (9%). Although the periprocedural complications and 30-day mortality rates were comparable between the groups, the 3-year survival rate after TAVR was notably lower in patients with active cancer (64.7%) than in those without active cancer (74.7%; p=0.016). Nevertheless, the 3-year survival rate of patients with limited-stage cancer (stage 1 or 2) did not significantly differ from those without cancer (70.6% vs 74.7%, p=0.50). Conclusions The patients with active cancer exhibited significantly reduced midterm survival rates. However, no distinct disparity existed in those with limited-stage cancer (stage 1 or 2). Although TAVR is a viable treatment in patients with AS with active cancer, the type and stage of cancer and prognosis should be carefully weighed in the decision-making process.
    Type of Medium: Online Resource
    ISSN: 2053-3624
    URL: Article
    DOI: 10.1136/openhrt-2023-002573
    Language: English
    Publisher: BMJ
    Publication Date: 2024
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  • 9
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    Incidence and predictors of prosthesis–patient mismatch after TAVI using SAPIEN 3 in Asian: differences between the newer and older balloon-expandable valve
    BMJ ; 2021
    In:  Open Heart Vol. 8, No. 1 ( 2021-03), p. e001531-
    Details
    In: Open Heart, BMJ, Vol. 8, No. 1 ( 2021-03), p. e001531-
    Abstract: 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.
    Type of Medium: Online Resource
    ISSN: 2053-3624
    URL: Article
    DOI: 10.1136/openhrt-2020-001531
    Language: English
    Publisher: BMJ
    Publication Date: 2021
    detail.hit.zdb_id: 2747269-3
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