Optimized CathEter vAlvular iNtervention Research Articles

Clinical Impact of Baseline Frailty Status and Residual Mitral Regurgitation After Transcatheter Edge-to-Edge Repair: Insights From the OCEAN-Mitral Registry.

The Clinical Frailty Scale (CFS) is a useful frailty marker for predicting clinical outcomes in patients undergoing invasive therapy. However, the clinical impact of CFS after transcatheter edge-to-edge repair in patients with mitral regurgitation (MR) remains unclear. This study aimed to elucidate the association between the baseline frail status defined by the CFS and clinical outcomes with or without postprocedural MR ≥2+ (post-MR ≥2+) after transcatheter edge-to-edge repair. Based on a Japanese multicenter registry (OCEAN [Optimized Catheter Valvular Intervention]-Mitral), data from 2078 patients with MR who underwent transcatheter edge-to-edge repair were analyzed. The patients were classified into 5 groups: CFS 1 to 3, 4, 5, 6, and ≥7. The procedural and clinical outcomes and post-MR ≥2+ were compared among the groups. All-cause mortality for up to 2 years was explored using Cox proportional hazards regression analysis. Although the rates of acute procedural success and post-MR ≥2+ were similar, all-cause mortality at 2 years was significantly increased across the 5 CFS categories (15.5%, 23.8%, 27.7%, 34.6%, and 48.8%, respectively, P<0.001). The incremental CFS categories and post-MR ≥2+ were independent predictive risk factors of all-cause mortality (all P<0.05). Among the patients with 5 CFS categories, the incidence of all-cause mortality was higher in those with post-MR ≥2+ than in those without (all P<0.05). Although prognosis was poor in patients with higher CFS grade after transcatheter edge-to-edge repair, minimizing modifiable factors of residual MR is warranted to improve the clinical outcomes. URL: https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000027188; Unique identifier: UMIN000023653.

Update on Prosthesis–Patient Mismatch Following Transcatheter Aortic Valve Replacement in Asian Patients

BackgroundProsthesis–patient mismatch (PPM) after transcatheter aortic valve replacement (TAVR) is of greater concern in Asians, considering their relatively smaller annular sizes compared with Westerners. However, the prognostic significance of PPM in Asian populations has not been demonstrated. ObjectivesThis study aimed to elucidate the prognostic value of PPM after TAVR in Asian patients. MethodsPatients undergoing TAVR from October 2013 to December 2019 were enrolled from the OCEAN-TAVI (Optimized CathEter vAlvular iNtervention—Transcatheter Aortic Valve Implantation) registry. PPM was classified based on the indexed effective orifice area as severe (≤0.65 cm2/m2) or moderate (0.66-0.85 cm2/m2) in the general population, and severe (≤0.55 cm2/m2) or moderate (0.56-0.70 cm2/m2) in the obese population (body mass index of ≥30 kg/m2). ResultsOf the 7,072 eligible patients, moderate and severe PPM were identified in 742 (10.5%) and 94 (1.3%) patients, respectively. Severe PPM relative to non-PPM was independently associated with higher adjusted risks for 3-year all-cause mortality (adjusted HR: 1.79; 95% CI: 1.16-2.78; P = 0.009) and heart failure hospitalization (adjusted HR: 1.88; 95% CI: 1.07-3.28; P = 0.027), whereas no significant difference in these outcomes was observed between moderate PPM and no PPM. ConclusionsSevere PPM following TAVR was observed in only 1.3% of our Japanese cohort, but was associated with an increased risk of mortality and heart failure hospitalization at 3 years. These results warrant the implementation of preventive strategies to obviate severe PPM after TAVR, also in Asian patients.

Predictive Factors of Cardiac Mortality Following TEER in Patients with Secondary Mitral Regurgitation

Background: Transcatheter edge-to-edge mitral valve repair (TEER) has emerged as a viable approach to addressing substantial secondary mitral regurgitation. In the contemporary landscape where ultimate heart failure-specific therapies, such as cardiac replacement modalities, are available, prognosticating a high-risk cohort susceptible to early cardiac mortality post-TEER is pivotal for formulating an effective therapeutic regimen. Methods: Our study encompassed individuals with secondary mitral regurgitation and chronic heart failure enlisted in the multi-center (Optimized CathEter vAlvular iNtervention (OCEAN)-Mitral registry. We conducted an assessment of baseline variables associated with cardiac death within one year following TEER. Results: Amongst the 1517 patients (median age: 78 years, 899 males), 101 experienced cardiac mortality during the 1-year observation period after undergoing TEER. Notably, a history of heart failure-related admissions within the preceding year, utilization of intravenous inotropes, and elevated plasma B-type natriuretic peptide levels emerged as independent prognosticators for the primary outcome (p &lt; 0.05 for all). Subsequently, we devised a novel risk-scoring system encompassing these variables, which significantly stratified the cumulative incidence of the 1-year primary outcome (16%, 8%, and 4%, p &lt; 0.001). Conclusions: Our study culminated in the development of a new risk-scoring system aimed at predicting 1-year cardiac mortality post-TEER.

One-Year Outcomes and Their Relationship to Residual Mitral Regurgitation After Transcatheter Edge-to-Edge Repair With MitraClip Device: Insights From the OCEAN-Mitral Registry.

Background Limited data are available about clinical outcomes and residual mitral regurgitation (MR) after transcatheter edge-to-edge repair in the large Asian-Pacific cohort. Methods and Results From the Optimized Catheter Valvular Intervention (OCEAN-Mitral) registry, a total of 2150 patients (primary cause of 34.6%) undergoing transcatheter edge-to-edge repair were analyzed and classified into 3 groups according to the residual MR severity at discharge: MR 0+/1+, 2+, and 3+/4+. The mortality and heart failure hospitalization rates at 1 year were 12.3% and 15.0%, respectively. Both MR and symptomatic improvement were sustained at 1 year with MR ≤2+ in 94.1% of patients and New York Heart Association functional class I/II in 95.0% of patients. Compared with residual MR 0+/1+ (20.4%) at discharge, both residual MR 2+ (30.2%; P < 0.001) and 3+/4+ (32.4%; P = 0.007) were associated with the higher incidence of death or heart failure hospitalization (adjusted hazard ratio [HR], 1.59; P < 0.001, and adjusted HR, 1.73; P = 0.008). New York Heart Association class III/IV at 1 year was more common in the MR 3+/4+ group (20.0%) than in the MR 0+/1+ (4.6%; P < 0.001) and MR 2+ (6.4%; P < 0.001) groups, and the proportion of New York Heart Association class I is significantly higher in the MR 1+ group (57.8%) than in the MR 2+ group (48.3%; P = 0.02). Conclusions The OCEAN-Mitral registry demonstrated favorable clinical outcomes and sustained MR reduction at 1 year in patients undergoing transcatheter edge-to-edge repair. Both residual MR 2+ and 3+/4+ after transcatheter edge-to-edge repair at discharge were associated with worse clinical outcomes compared with residual MR 0+/1+. Registration Information https://upload.umin.ac.jp. Identifier: UMIN000023653.

Short-Term Outcomes Following Transcatheter Edge-to-Edge Repair: Insights From the OCEAN-Mitral Registry

BackgroundTranscatheter edge-to-edge repair (TEER) is a less invasive treatment for patients with mitral regurgitation (MR). Limited safety and efficacy data of TEER with MitraClip, including the fourth-generation (G4) system, in a large cohort, are available. ObjectivesThis study aimed to summarize the initial experience of the TEER system in patients with MR from a large registry in Japan. MethodsThe OCEAN (Optimized CathEter vAlvular iNtervention)-Mitral Registry is an ongoing, prospective, investigator-initiated, multicenter, observational registry for patients with primary and secondary MR undergoing transcatheter mitral valve therapies. A total of 21 centers participated in the registry. Patients undergoing TEER were enrolled, and their characteristics, procedural details, and clinical outcomes were recorded. ResultsIn total, 2,150 patients including 1,605 patients (75.0%) with secondary MR, were enrolled between April 2018 and June 2021. The median age was 80 years, and 43.7% were women. The median device and fluoroscopy times were 60 and 26 minutes, respectively. Those with the G4 system (618/2,150 [28.7%]) were significantly shorter than those with the second generation (G2) system (1,532/2,150 [71.3%]). Overall, 94.6% met acute procedural success without significant differences between the 2 systems (G2 94.7% vs G4 94.6%; P = 0.961). ConclusionsThe OCEAN-Mitral registry has demonstrated the short-term outcomes of TEER systems, including the G4 system, in symptomatic patients with primary and secondary MR. The acute procedural success rate in the G2 system was excellent, and that in the G4 system was expected to improve with the multidisciplinary heart valve team approach. (Japanese Registry study of valvular heart diseases treatment and prognosis; UMIN000023653)

Initial Japanese Multicenter Experience and Age-Related Outcomes Following Left Atrial Appendage Closure: The OCEAN-LAAC Registry

BackgroundLimited data are available describing left atrial appendage closure (LAAC) and age-related outcomes in Asians. ObjectivesThis study summarizes the initial experience with LAAC in Japan and determines age-related clinical outcomes in patients with nonvalvular atrial fibrillation undergoing percutaneous LAAC. MethodsIn an ongoing, prospective, investigator-initiated, multicenter, observational registry of patients undergoing LAAC in Japan, we analyzed short-term clinical outcomes in patients with nonvalvular atrial fibrillation who underwent LAAC. Patients were classified into younger, middle-aged, and elderly groups (≤70, 70 to 80, and >80 years of age, respectively) to determine age-related outcomes. ResultsPatients (n = 548; mean age, 76.4 ± 8.1 years; male, 70.3%) who underwent LAAC at 19 Japanese centers between September 2019 and June 2021 were enrolled in the study, including 104, 271, and 173 patients in the younger, middle-aged, and elderly groups, respectively. Participants had a high-risk of bleeding and thromboembolism with a mean CHADS2 score of 3.1 ± 1.3, a mean CHA2DS2-VASc score of 4.7 ± 1.5, and a mean HAS-BLED score of 3.2 ± 1.0. Device success rates were 96.5% and anticoagulants discontinuation at the 45-day follow-up was achieved in 89.9%. In-hospital outcomes were not significantly different, but major bleeding events during the 45-day follow-up were significantly higher in the elderly group compared to the other groups (younger vs middle-aged vs elderly, 1.0% vs 3.7% vs 6.9%, respectively; P = 0.047) despite the same postoperative drug regimens. ConclusionsThe initial Japanese experience with LAAC demonstrated safety and efficacy; however, perioperative bleeding events were more common in the elderly and postoperative drug regimens must be tailored (OCEAN-LAAC [Optimized Catheter Valvular Intervention–Left Atrial Appendage Closure] registry; UMIN000038498)

Effect of Sex on Mortality and Left Ventricular Remodeling After Transcatheter Aortic Valve Implantation.

The effect of sex on mortality is controversial; furthermore, sex differences in left ventricular (LV) remodeling after transcatheter aortic valve implantation (TAVI) remain unknown. This study included 2,588 patients (1,793 [69.3%] female) enrolled in the Optimized CathEter vAlvular iNtervention (OCEAN)-TAVI Japanese multicenter registry between October 2013 and May 2017. We retrospectively analyzed the effect of sex on mortality, and evaluated changes in the LV mass index (LVMI) after TAVI. Female sex was significantly associated with lower all-cause and cardiovascular mortality (log-rank P<0.001 for both). Multivariate analysis showed that female sex was independently associated with lower cumulative long-term mortality (hazard ratio 0.615; 95% confidence interval 0.512-0.738; P<0.001). Regression in the LVMI was observed in both sexes, and there was no significant difference in the percentage LVMI regression from baseline to 1 year after TAVI between women and men. Women had a survival advantage compared with men among patients with LVMI regression at 1 year, but not among patients with no LVMI regression. We found that female sex is associated with better survival outcomes after TAVI in a large Japanese registry. Although LVMI regression was observed in women and men after TAVI, post-procedural LV mass regression may be related to the sex differences in mortality.

Long-Term Prognostic Value of the Society of Thoracic Surgery Risk Score in Patients Undergoing Transcatheter Aortic Valve Implantation (From the OCEAN-TAVI Registry)

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

The Impact of Baseline Thrombocytopenia on Late Bleeding and Mortality After Transcatheter Aortic Valve Implantation (From the Japanese Multicenter OCEAN-TAVI Registry)

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

Clinical risk model for predicting 1-year mortality after transcatheter aortic valve replacement.

ObjectivesEstimating 1‐year life expectancy is an essential factor when evaluating appropriate indicators for transcatheter aortic valve replacement (TAVR).BackgroundIt is clinically useful in developing a reliable risk model for predicting 1‐year mortality after TAVR.MethodsWe evaluated 2,588 patients who underwent TAVR using data from the Optimized CathEter vAlvular iNtervention (OCEAN) Japanese multicenter registry from October 2013 to May 2017. The 1‐year clinical follow‐up was achieved by 99.5% of the entire population (n = 2,575). Patients were randomly divided into two cohorts: the derivation cohort (n = 1,931, 75% of the study population) and the validation cohort (n = 644). Considerable clinical variables including individual patient's comorbidities and frailty markers were used for predicting 1‐year mortality following TAVR.ResultsIn the derivation cohort, a multivariate logistic regression analysis demonstrated that sex, body mass index, Clinical Frailty Scale, atrial fibrillation, peripheral artery disease, prior cardiac surgery, serum albumin, renal function as estimated glomerular filtration rate, and presence of pulmonary disease were independent predictors of 1‐year mortality after TAVR. Using these variables, a risk prediction model was constructed to estimate the 1‐year risk of mortality after TAVR. In the validation cohort, the risk prediction model revealed high discrimination ability and acceptable calibration with area under the curve of 0.763 (95% confidence interval, 0.728–0.795, p < .001) in the receiver operating characteristics curve analysis and a Hosmer–Lemeshow χ 2 statistic of 5.96 (p = .65).ConclusionsThis risk prediction model for 1‐year mortality may be a reliable tool for risk stratification and identification of adequate candidates in patients undergoing TAVR.

Clinical outcomes of transcatheter aortic valve implantation (TAVI) in nonagenarians from the optimized catheter valvular intervention-TAVI registry.

The purpose of this study was to investigate 30-day and 2-year clinical outcomes, and predictors of 2-year mortality in nonagenarians undergoing transcatheter aortic valve implantation (TAVI). TAVI has been applied to nonagenarians. However, sufficient clinical data in nonagenarians who could benefit from TAVI are limited. We evaluated the data from the optimized catheter valvular intervention-TAVI registry. Clinical outcomes were compared between patients' age ≥90 years and age <90 years. Predictive factors of 2-year mortality were assessed by multivariable Cox regression analyses. From October 2013 to May 2017, a total of 375 nonagenarians (age ≥90 years) and 2,213 younger patients (age <90 years) were included. Although nonagenarians had a higher surgical risk score, 30-day clinical outcomes were similar between two groups. There were no significant differences in 2-year mortality (22.0% vs. 17.3%; p = .11) and stroke (5.5% vs. 3.9%; p = .31); however, 2-year heart failure readmission was higher in nonagenarians (13.3% vs. 9.0%; p = .03). After adjusting covariates, age ≥90 years was not independent predictor for 2-year outcomes. In nonagenarians, female sex (hazard ratio [HR] = 0.43; 95% confidence interval [CI] = 0.26-0.74; p = .002), chronic kidney disease grade ≥4 (HR = 2.14; 95% CI = 1.21-3.64; p = .01), and Clinical Frailty Scale ≥4 (HR = 1.82; 95% CI = 1.02-3.42; p = .04) were independently associated with 2-year mortality. Clinical outcomes of TAVI in selected nonagenarians were favorable. Severe renal dysfunction and frailty may be important factors to predict mid-term mortality after TAVI in nonagenarians.

Clinical Impact of Preprocedural Moderate or Severe Mitral Regurgitation on Outcomes After Transcatheter Aortic Valve Replacement

BackgroundThe 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. MethodsA 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%). ResultsModerate 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). ConclusionsModerate 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.

Transcatheter aortic valve replacement outcomes in Japan: Optimized CathEter vAlvular iNtervention (OCEAN) Japanese multicenter registry.

We aimed to assess real-world clinical outcomes of transcatheter aortic valve replacement (TAVR) in Japan. 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. 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). 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. 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.

Patients Refusing Transcatheter Aortic Valve Replacement Even Once Have Poorer Clinical Outcomes.

BackgroundAlthough 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 ResultsWe 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).ConclusionsRefusing TAVR even once led to poorer prognosis; therefore, this fact should be clearly discussed when obtaining informed consent.

Frequency and Consequences of Cognitive Impairmentin Patients Underwent Transcatheter Aortic Valve Implantation

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.

Impact of pre-procedural hyponatremia on clinical outcomes after transcatheter aortic valve replacement: A propensity-matched analysis.

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). 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. 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). Pre-procedural hyponatremia may be a useful marker for predicting early and mid-term clinical outcomes after TAVR.

Impact of frailty markers on outcomes after transcatheter aortic valve replacement: insights from a Japanese multicenter registry.

There are no standardized criteria for measuring patients' frailty. We examined prognosis based on four frailty markers [serum albumin level, grip strength, gait speed, and clinical frailty scale (CFS)] in patients who underwent transcatheter aortic valve replacement (TAVR) between October 2013 and April 2016 and were recorded in the Optimized CathEter vAlvular iNtervention (OCEAN) Japanese multicenter registry. Serum albumin level was assessed by dividing patients into two groups: hypoalbuminemia or non-hypoalbuminemia according to their serum albumin level. Clinical outcomes including all-cause, cardiovascular and non-cardiovascular mortality rates after TAVR were compared. During the follow-up period cumulative all-cause, cardiovascular and non-cardiovascular mortality rates were significantly higher in the hypoalbuminemia group than in the non-hypoalbuminemia group. This result remained unchanged even after a propensity-matched model was used in terms of cumulative all-cause and non-cardiovascular mortality; however, differences in cardiovascular mortality rates were attenuated. To consider the impact of grip strength patients were divided into a low or high peak grip strength group based on classification and regression tree (CART) survival analysis. The clinical outcomes for each sex were compared between the two groups. In both sexes the cumulative 1-year mortality rates were significantly different between the two groups. To investigate gait speed patients were classified into two gait speed groups (low or high gait speed group) based on CART survival analysis. Clinical outcomes were compared between the two groups. The cumulative 1-year mortality rate was significantly different between the two gait speed groups. The effect of CFS on prognosis after TAVR was assessed. Patients were categorized into five groups based on the following CFS scores: CFS1-3, CFS4, CFS5, CFS6, and CFS ≥7. We evaluated the relationship between the CFS score and other indicators of frailty markers. We also assessed the mid-term mortality among the five groups. The CFS score had a significant correlation with other frailty markers. The cumulative 1-year mortality increased with an increasing CFS score. In the Cox regression multivariable analysis, the CFS score was an independent predictive factor of an increased late cumulative mortality risk. In conclusion, the results suggest that serum albumin level, grip strength, gait speed, and CFS score are all useful indicators when considering the optimal indications and risk stratification for TAVR.

Transcatheter aortic valve implantation in patients with an extremely small native aortic annulus: The OCEAN-TAVI registry

BackgroundTranscatheter aortic valve implantation (TAVI) has been reported to be advantageous over surgical aortic valve replacement owing to the low incidence of prosthesis-patient mismatch (PPM) and large effective orifice area (EOA). However, data on TAVI for extremely small annuli are limited. The present study aimed to compare post-procedural hemodynamics and morphology between 20-mm and 23-mm Sapien XT (SXT) transcatheter heart valves (THVs) with extremely small annuli (<314mm2). MethodsAll patients with severe aortic stenosis treated with TAVI at eight Japanese centers between October 2013 and January 2016 were prospectively included in the Optimized CathEter vAlvular iNtervention (OCEAN-TAVI) registry. In the overall cohort of 20-mm (19 patients) and 23-mm SXTs (492 patients) with extremely small annuli, the patient groups were matched one-to-one using propensity scores, and post-procedural echocardiography and multidetector computed tomography data were compared for 18 matched patients from each group (matched cohort). ResultsIn the matched cohort, the mean gradient was higher (15.4±4.1 vs. 12.2±4.8mmHg, p=0.04), EOA was lower (1.22±0.25 vs. 1.44±0.37cm2, p=0.02) and THV area was lower (245.6±19.1 vs. 298.5±33.3mm2, p<0.01) in the 20-mm group than in the 23-mm group. However, all patients in both groups were asymptomatic. Although moderate PPM was more prevalent in the 20-mm group than in the 23-mm group (31.6% vs. 7.9%, p<0.01), the incidence of severe PPM was low and similar between the groups (0% vs. 0.4%, p=1.00) in the overall cohort. ConclusionA 20-mm SXT in patients who require a small bioprosthesis leads to favorable short-term outcomes.

The incidence, predictive factors and prognosis of acute pulmonary complications after transcatheter aortic valve implantation.

Although acute pulmonary complications (APCs), such as the exacerbation of pulmonary disease (PD) or a newly developed pulmonary event, are thought to be catastrophic after invasive therapy, little is known about the occurrence of APCs after transcatheter aortic valve implantation (TAVI). This study aims to clarify the incidence, predictive factors and impact of APCs on prognosis after TAVI. We identified 749 patients who underwent TAVI, using data from the Optimized CathEter vAlvular iNtervention (OCEAN-TAVI) Japanese multicentre registry. APCs were defined as exacerbation of a comorbidity or newly developed PD during hospitalization. Patients were divided into 2 groups: an APC group (1.5%, 11/749) and a non-APC group (98.5%, 738/749). Clinical and prognostic outcomes were compared, and predictive factors for APCs were assessed. Procedure-related death did not differ between the groups (0.4% vs 0.0%, P = 1.00), although 30-day mortality was significantly higher in the APC group than in the non-APC group (27.3% vs 1.6%, P = 0.001) and the difference in cumulative 1-year mortality increased further (72.7% vs 8.6%, log-rank test: P < 0.001). In particular, concomitant PD and transapical (TA) approach were identified as predictors of APCs after TAVI [univariable odds ratio (uOR) = 24.2, 95% confidence interval (CI) = 3.08-189.9, P = 0.002; uOR = 3.69, 95% CI = 1.11-12.3, P = 0.033, respectively]. Although rare, the occurrence of APCs after TAVI was associated with extremely poor prognosis. Patients undergoing TAVI with concomitant PD and/or TA require careful consideration to avoid the risk of APCs.

Impact of the Clinical Frailty Scale on Outcomes After Transcatheter Aortic Valve Replacement.

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. 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. 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). 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.