Late kidney injury after transcatheter aortic valve replacement.

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

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

OBJECTIVES: The purpose of this study was to investigate 30-day and 2-year clinical outcomes, and predictors of 2-year mortality in nonagenarians undergoing transcatheter aortic valve implantation (TAVI). BACKGROUND: TAVI has been applied to nonagenarians. However, sufficient clinical data in nonagenarians who could benefit from TAVI are limited. METHODS: We evaluated the data from the optimized catheter valvular intervention-TAVI registry. Clinical outcomes were compared between patients' age ≥90 years and age <90 years. Predictive factors of 2-year mortality were assessed by multivariable Cox regression analyses. RESULTS: 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. CONCLUSIONS: 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 risk model for predicting 1-year mortality after transcatheter aortic valve replacement.

OBJECTIVES: Estimating 1-year life expectancy is an essential factor when evaluating appropriate indicators for transcatheter aortic valve replacement (TAVR). BACKGROUND: It is clinically useful in developing a reliable risk model for predicting 1-year mortality after TAVR. METHODS: We evaluated 2,588 patients who underwent TAVR using data from the Optimized CathEter vAlvular iNtervention (OCEAN) Japanese multicenter registry from October 2013 to May 2017. The 1-year clinical follow-up was achieved by 99.5% of the entire population (n = 2,575). Patients were randomly divided into two cohorts: the derivation cohort (n = 1,931, 75% of the study population) and the validation cohort (n = 644). Considerable clinical variables including individual patient's comorbidities and frailty markers were used for predicting 1-year mortality following TAVR. RESULTS: In the derivation cohort, a multivariate logistic regression analysis demonstrated that sex, body mass index, Clinical Frailty Scale, atrial fibrillation, peripheral artery disease, prior cardiac surgery, serum albumin, renal function as estimated glomerular filtration rate, and presence of pulmonary disease were independent predictors of 1-year mortality after TAVR. Using these variables, a risk prediction model was constructed to estimate the 1-year risk of mortality after TAVR. In the validation cohort, the risk prediction model revealed high discrimination ability and acceptable calibration with area under the curve of 0.763 (95% confidence interval, 0.728-0.795, p < .001) in the receiver operating characteristics curve analysis and a Hosmer-Lemeshow χ2 statistic of 5.96 (p = .65). CONCLUSIONS: This risk prediction model for 1-year mortality may be a reliable tool for risk stratification and identification of adequate candidates in patients undergoing TAVR.

In-hospital Bleeding Outcomes of Oral Anticoagulant and Dual Antiplatelet Therapy During Percutaneous Coronary Intervention: An Analysis From the Japanese Nationwide Registry.

ABSTRACT: The type of periprocedural antithrombotic regimen that is the safest and most effective in percutaneous coronary intervention (PCI) patients on oral anticoagulant (OAC) therapy has not been fully investigated. We aimed to retrospectively investigate the in-hospital bleeding outcomes of patients receiving OAC and antiplatelet therapies during PCI using Japanese nationwide multicenter registry data. A total of 26,938 patients who underwent PCI with OAC and antiplatelet therapies between 2016 and 2017 were included. We investigated in-hospital bleeding requiring blood transfusion, mortality, and stent thrombosis according to the antithrombotic regimens used at the time of PCI: OAC + single antiplatelet therapy (double therapy) and OAC + dual antiplatelet therapy (triple therapy). The antiplatelet agents included aspirin, clopidogrel, and prasugrel. The OAC agents included warfarin and direct OACs. Adjusting the dose of OAC or intermitting OAC before PCI was at each operator's discretion. In the study population [mean age (SD), 73.5 (9.5) years; women, 21.5%], the double therapy and triple therapy groups comprised 5546 (20.6%) and 21,392 (79.4%) patients, respectively. Bleeding requiring transfusion was not significantly different between the groups [adjusted odds ratio (aOR), 0.700; 95% confidence interval (CI), 0.420-1.160; P = 0.165] (triple therapy as a reference). Mortality was not significantly different (aOR, 1.370; 95% CI, 0.790-2.360; P = 0.258). Stent thrombosis was significantly different between the groups (aOR, 3.310; 95% CI, 1.040-10.500; P = 0.042) (triple therapy as a reference). In conclusion, for patients on OAC therapy who underwent PCI, periprocedural triple therapy may be safe with respect to in-hospital bleeding risks. However, further investigations are warranted to establish the safety and efficacy of periprocedural triple therapy.

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

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

Short-term dual anti-platelet therapy decreases long-term cardiovascular mortality after transcatheter aortic valve replacement.

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.

Risk assessment in patients with left ventricular systolic dysfunction following transcatheter aortic valve replacement.

BACKGROUND: Mortality following transcatheter aortic valve replacement (TAVR) in patients with post-procedural left ventricular systolic dysfunction remains high. We investigated clinical variables associating with worse clinical outcomes following TAVR in patients with systolic dysfunction. METHODS: We retrospectively investigated 2588 patients with severe aortic stenosis who received TAVR and were enrolled in the optimized transcatheter valvular intervention (OCEAN-TAVI) multicenter registry (UMIN000020423). The association between the clinical variables following TAVR and 2-year cardiovascular mortality was investigated among those with post-TAVR left ventricular ejection fraction less than 50%. RESULTS: A total of 298 patients (median 85 years old, 131 men) were included. The presence of moderate or greater tricuspid regurgitation following TAVR was independently associated with 2-year mortality (adjusted hazard ratio 3.41, 95% confidence interval 1.15-10.1), and significantly discriminated 2-year cardiovascular mortality (30% vs. 12%, p = 0.001). No patients with any improvement in tricuspid regurgitation had cardiovascular death. CONCLUSION: Following TAVR, the existence of significant tricuspid regurgitation was associated with cardiovascular mortality in patients with heart failure with reduced ejection fraction.

Creatinine Score Can Predict Persistent Renal Dysfunction Following Trans-Catheter Aortic Valve Replacement.

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.

Malnutrition among elderly patients with severe aortic stenosis.

BACKGROUND: Most patients with aortic stenosis (AS) are elderly. To achieve favorable outcomes after interventional treatments, careful management including adequate nutritional support is required. However, there has been a lack of knowledge about the prevalence of malnutrition and factors related to it. AIMS: To explore the prevalence of malnutrition and its related factors in patients with severe AS. METHODS: This was a single-institution, cross-sectional study. A total of 300 consecutive older patients (mean age, 83.8 ± 0.5 years) with AS were prospectively enrolled. Nutritional status was evaluated with the Mini Nutritional Assessment-Short Form (MNA-SF). Cardiac, kidney, physical, cognitive functions, instrumental activities of daily living (IADL) as measured with the Frenchay Activities Index (FAI), medical history, and comorbidities were evaluated as potentially related factors. Multiple logistic regression analysis was performed to identify factors that were significantly associated with the MNA-SF. RESULTS: The mean (SD) score of the MNA-SF was 10.9 (2.5). 34 patients (11.3%) and 127 patients (42.3%) met the criteria for malnutrition and at risk of malnutrition, respectively. On multiple logistic regression analysis, female sex (OR 3.455, 95% CI 1.045-11.42, P = 0.042), NYHA class (OR 3.625, 95% CI 1.627-8.074, P = 0.002), left ventricular ejection fraction (/10%) (OR 0.961, 95% CI 0.932-0.991, P = 0.010), and FAI score (/10 points) (OR 0.911, 95% CI 0.864-0.961, P < 0.001) were significantly related to malnutrition. CONCLUSIONS: The prevalence of malnutrition was high among older persons with severe AS, and female sex, poor cardiac function, and lower IADL were independently related to it.

Incidence, predictors, and midterm clinical outcomes of left ventricular obstruction after transcatheter aortic valve implantation.

OBJECTIVES: We aimed to evaluate the incidence and midterm clinical outcomes of left ventricular obstruction (LVO) after transcatheter aortic valve implantation (TAVI). BACKGROUNDS: LVO is occasionally unmasked following valve replacement for severe aortic stenosis. However, little is known about the prevalence and effects of LVO after TAVI. METHODS: A total of 158 patients who underwent TAVI in our center between October 2013 and November 2015 received echocardiographic evaluations at baseline; before hospital discharge; and at 3, 6, and 12 months after TAVI. LVO was defined as a peak pressure gradient >30 mm Hg. RESULTS: Over 1 year of follow-up after TAVI, 21 patients (13.3%) demonstrated postprocedural LVO. The incidence was highest at 3-months follow-up and decreased at 6 months or later. Of the 21 patients with LVO, 20 (95.2%) demonstrated midventricular obstruction (MVO), whereas only 1 (4.8%) showed obstruction of the outflow tract (LVOT) with systolic anterior motion (SAM) of the mitral leaflet. In a multivariate analysis, the LVOT diameter (odds ratio [OR], 0.45; 95% confidence interval [CI], 0.30-0.67; P < 0.001), transvalvular velocity (OR, 2.44; 95% CI, 1.13-5.26; P = 0.023), and the presence of accelerated intraventricular flow at baseline (OR, 6.13; 95% CI, 1.49-25.2; P = 0.012) were associated with the occurrence of LVO. Postprocedural LVO was not associated with midterm all-cause death or heart failure events. CONCLUSION: In patients who underwent TAVI, MVO occurred more often than LVOT obstruction. However, the occurrence of postprocedural LVO was not associated with worsened clinical outcomes in these patients.

CT imaging before transcatheter aortic valve implantation (TAVI) using variable helical pitch scanning and its diagnostic performance for coronary artery disease.

OBJECTIVES: To evaluate the effectiveness of CT before TAVI using variable helical pitch (VHP) scanning and its diagnostic performance for coronary artery disease (CAD). METHODS: Sixty patients (84.4 ± 4.6 years) scheduled for TAVI underwent CT using VHP scanning with the contrast material (CM) volume calculated as scanning time × weight [kg] × 0.06 mL. Retrospective electrocardiography (ECG)-gated scanning was utilized to examine the thorax, and non-ECG-gated scanning of the abdomen immediately followed. We analyzed CT attenuation values of the coronary arteries, aorta, iliac and femoral arteries. The coronary CT angiography images were evaluated for the presence of stenosis (≥50 %); invasive coronary angiography served as a reference standard. RESULTS: The average attenuations of all of the arteries were greater than 400 HU. We could evaluate the peripheral access vessels and dimensions of the ascending aorta, aortic root, and aortic annulus in all patients. The average volume of CM was 38.7 ± 8.5 mL. On per-patient and vessel analysis, CT showed 91.7 % and 89.5 % sensitivity, and 91.3 % and 97.4 % negative predictive value (NPV). CONCLUSIONS: CT using VHP scanning with an average CM volume of 38.7 mL is useful before TAVI and had a high sensitivity and NPV in excluding obstructive CAD. KEY POINTS: • TAVI-planning CT using variable helical pitch (VHP) scanning is useful. • The average volume of contrast material was 38.7 ± 8.5 mL. • The average attenuations of all the arteries were >400 HU. • This CT had a high sensitivity and NPV for excluding obstructive CAD.

Delivery balloon-induced ascending aortic dissection: An unusual complication during transcatheter aortic valve implantation.

Transcatheter aortic valve implantation (TAVI) is a relatively mature technique that is generally accepted as a promising treatment for inoperable patients and those who are high-risk candidates for surgical aortic replacement. Although severe complications in the aortic valve complex, such as annular or aortic root rupture, are not frequently observed, these events could easily lead to catastrophic outcomes, and therefore remain major issues during TAVI. However, there remains a paucity of data describing these catastrophic complications because of their low incidence. We encountered the case of an 88-year-old woman complicated by a dissection of the ascending aorta during TAVI from an "unusual" cause: injury due to the delivery of a balloon-expandable valve to a very narrow and heavily calcified sinotubular junction (STJ). This is the first report to demonstrate the mechanism of this complication; even a delivery balloon, not a stent frame, with low inflation pressure might injure a narrow STJ and lead to an aortic dissection. Therefore, the use of oversized delivery balloons should be avoided in patients with a narrow and calcified STJ. © 2015 Wiley Periodicals, Inc.

Streamlining the learning process for TAVI: Insight from a comparative analysis of the OCEAN-TAVI and the massy registries.

BACKGROUNDS: To facilitate the learning process of transcatheter aortic valve implantation (TAVI) in Japan, unique supporting systems (e.g., on-site proctor and web-based screening systems) have been developed. Nevertheless, little is known about real-world clinical outcomes after TAVI in Japan compared with their European counterparts. METHODS: From the optimized catheter valvular intervention (OCEAN-TAVI, Japan) and the Institut Cardiovasculaire Paris Sud (Massy, France) registries, we evaluated a total of 134 and 178 patients, respectively, who underwent transfemoral TAVI during the same time period. RESULTS: Among the French cohort, about half of the patients (N = 81, 45.5%) were treated with the Edwards SAPIEN XT. Body surface area was significantly smaller in the Japanese cohort, although operative risks for both cohorts were almost the same. A greater percentage of patients in the Japanese cohort were implanted with 23 mm valves compared with the French cohort (73.1% vs. 23.0%, P < 0.001), reflecting the smaller annulus diameter (21.8 ± 1.6 vs. 23.8 ± 2.4 mm, P < 0.001). All-cause 30-day mortality (0% vs. 0.6%, P = 1.000) and 30-day combined safety endpoint based on the Valve Academic Research Consortium 2 (VARC2) criteria (9.7% vs. 11.2%, P = 0.713) were similar when limiting the analysis to patients treated with the Edwards SAPIEN XT. CONCLUSIONS: Despite the unfavorable aortic anatomy of the Japanese patients, their clinical outcomes after transfemoral TAVI were excellent with the same degree of safety as in an experienced European institute. This minimized learning process achieved the use of unique support systems.

Physical frailty in older people with severe aortic stenosis.

BACKGROUND: Assessment of physical frailty is important among elderly with severe aortic stenosis (AS) when considering treatment. AIMS: We aimed to: (1) investigate the prevalence of physical frailty in older people with severe AS and (2) examine factors related to physical frailty. METHODS: A total of 125 consecutive elderly AS patients (mean age 84.6 ± 4.4 year) were enrolled. Physical frailty was defined as scoring ≤8 points on the short physical performance battery (SPPB). Factors likely related to physical frailty, including cardiac function, nutritional and metabolic status, kidney function, medical history, and comorbidities, were evaluated. Logistic regression analyses were used to examine which factors were related to physical frailty. RESULTS: Physical frailty was prevalent in 38.4 %. After sex and age adjusted, the following were significantly related to physical frailty: LVEF (adjusted OR per 10 % decrease: 1.39, p < 0.05), the Mini Nutritional Assessment-Short Form (adjusted OR per 1 point decrease: 1.21, p < 0.05), serum albumin (adjusted OR per 1 g/dL decrease: 2.64, p < 0.05), HDL-C (adjusted OR per 10 mg/dL decrease: 1.52, p < 0.01), eGFR (adjusted OR per 10 mL/min decrease: 1.59, p < 0.05), grip strength (adjusted OR per 10 kg decrease: 3.60, p < 0.01), coronary heart disease (adjusted OR: 2.78, p < 0.01), cerebrovascular disease (adjusted OR: 6.06, p < 0.01), and musculoskeletal disorders (adjusted OR: 3.28, p < 0.01). CONCLUSIONS: The prevalence of physical frailty is high and related to nutritional status, comorbidities, and cardiac status.

Size of Self-Expandable Transcatheter Heart Valve and Mid-Term Adverse Events After Transcatheter Aortic Valve Replacement.

The hemodynamic performance of self-expandable valves (SEVs) is a preferable choice for small aortic annuli in transcatheter aortic valve replacement (TAVR). However, no data are, so far, available regarding the relation between the size of SEVs and clinical outcomes. This study aimed to evaluate the impact of prosthesis size on adverse events after TAVR using SEVs. We retrospectively analyzed 1,400 patients (23-mm SEV: 13.6%) who underwent TAVR using SEVs at 12 centers. The impact of SEV size on all-cause death and heart failure (HF) after TAVR was evaluated by multivariate Cox regression and propensity score (PS) matching analysis. During the follow-up period (median 511 days), 201 all-cause deaths and 87 HF rehospitalizations were observed. The incidence of all-cause death was comparable between small- (23-mm SEV) and larger-sized (26- or 29-mm SEV) (16.8% vs 13.9%, log-rank p = 0.29). The size of SEV was not associated with a higher incidence of all-cause death (hazard ratio [HR] 1.21, 95% confidence interval [CI] 0.79 to 1.86 in Cox regression; HR 1.31, 95% CI 0.77 to 2.23 in PS matching) and HF after TAVR (subdistribution HR 0.79, 95% CI 0.37 to 1.72 in Cox regression; subdistribution HR 1.00, 95% CI 0.44 to 2.30 in PS matching). The multivariate model including postprocedural prosthesis-patient mismatch showed consistent results. In conclusion, small SEVs had comparable midterm clinical outcomes to larger-sized SEVs, even if the prosthesis-patient mismatch was observed after TAVR.

Midterm outcomes of transcatheter aortic valve replacement in patients with active cancer.

OBJECTIVES: 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.

Difference in Cardiac Response after Transcatheter Aortic Valve Implantation according to Flow and Gradient Pattern.

BACKGROUND: In patients undergoing transcatheter aortic valve implantation (TAVI) for severe aortic stenosis (AS), data on the differences in subsequent cardiac structure and function among stratified groups with flow gradient patterns through the aortic valve are insufficient. METHODS: In this large multicenter study, 4,523 patients undergoing TAVI for severe AS between 2013 and 2019 were divided into 3 groups according to the following criteria: (1) high-gradient AS (HG-AS) (mean pressure gradient [MPG] ≥40 mmHg), (2) classical low-flow low-gradient AS (cLFLG-AS) (MPG <40 mmHg, left ventricular [LV] ejection fraction [LVEF] <50%), and (3) paradoxical low-flow low-gradient AS (pLFLG-AS) (MPG <40 mmHg, LVEF ≥50% but stroke volume index [SVi] <35 mL/m2). Echocardiography was performed at baseline, post-procedure, and 1 year post-TAVI. RESULTS: 3,697, 507, and 319 patients had HG-AS, cLFLG-AS, and pLFLG-AS, respectively. After adjusting for clinical factors, cLFLG-AS and pLFLG-AS had an approximately 1.5-fold higher 2-year all-cause mortality compared with HG-AS. During 1 year following TAVI, compared with HG-AS, cLFLG-AS showed greater reduction of LV systolic diameter (LVDs) and LV diastolic diameter (LVDd) and greater increase of LVEF (p<0.001 for all), and changes in LV mass index (LVMi) and SVi were comparable (p=0.915 and p=0.821, respectively). However, pLFLG-AS demonstrated less reduction of LVDs and LVDd (p=0.039 and p=0.001, respectively), less improvement of LVEF and LVMi (p=0.045 and p<0.001, respectively), and comparable change in SVi (p=0.364). CONCLUSIONS: During 1 year post-TAVI, compared with HG-AS, cLFLG-AS achieves smaller LV diameters, greater increase in LVEF, and comparable regression of LVMi, whereas pLFLG-AS does not.

Transcatheter Aortic Valve Implantation in Japanese Patients With Large Annulus: The OCEAN-TAVI Registry.

Background: East Asians have smaller aortic valve complexes than individuals from Western countries, and few studies have reported transcatheter aortic valve implantation (TAVI) outcomes in Asian patients with a large annulus. Objectives: This study aimed to compare the short- and long-term outcomes of TAVI using balloon-expandable valves (BEVs) and self-expandable valves (SEVs) in Asian patients with a large annulus. Methods: The study retrospectively analyzed the data from the OCEAN-TAVI (Optimized Transcatheter Valvular Intervention Transcatheter Aortic Valve Implantation) registry. A large annulus was defined by an annular area ≥500 mm2 and an average diameter ≥25 mm as measured by computed tomography. The primary endpoint was 3-year all-cause mortality. Secondary endpoints were 3-year heart failure rehospitalization (HFR) after TAVI, short-term outcomes of TAVI, and changes in valve function 2 years after TAVI. Results: Among 773 patients, 671 underwent BEV TAVI. The SEV TAVI group showed a significantly higher incidence of greater than moderate paravalvular leakage (PVL) (P < 0.001), and an increased pacemaker implantation rate (P = 0.035). The incidence of prosthesis-patient mismatch did not differ between the 2 groups. The Kaplan-Meier curve showed no significant differences in 3-year all-cause mortality and HFR rates (log-rank P = 0.900), and echocardiographic valve function at 2 years post-TAVI did not differ between the 2 groups. Conclusions: The lack of differences in postoperative valve performance and long-term prognosis between BEV TAVI and SEV TAVI highlights the importance of selecting valves that can reduce the pacemaker implantation rate and PVL grade in the acute phase in patients with a large annulus. (Optimized Transcatheter Valvular Intervention Transcatheter Aortic Valve Implantation [OCEAN-TAVI]; UMIN000020423).