Characteristics, Antithrombotic Patterns, and Prognostic Outcomes in Claudication and Critical Limb-Threatening Ischemia Undergoing Endovascular Therapy.

PURPOSE: The underlying difference between intermittent claudication (IC) and critical limb-threatening ischemia (CLTI) still remains unclear. This prospective multicenter observational study aimed to clarify differences in clinical features and prognostic outcomes between IC and CLTI, and prognostic factors in patients undergoing endovascular therapy (EVT). MATERIALS AND METHODS: A total of 692 patients with 808 limbs were enrolled from 20 institutions in Japan. The primary measurements were the 3-year rates of major adverse cardiovascular event (MACE) and reintervention. RESULTS: Among patients, 79.0% had IC and 21.0% had CLTI. Patients with CLTI were more frequently women and more likely to have impaired functional status, undernutrition, comorbidities, hypercoagulation, hyperinflammation, distal artery disease, short single antiplatelet and long anticoagulation therapies, and late cilostazol than patients with IC. Aortoiliac and femoropopliteal diseases were dominant in patients with IC and infrapopliteal disease was dominant in patients with CLTI. Patients with CLTI underwent less frequently aortoiliac intervention and more frequently infrapopliteal intervention than patients with IC. Longitudinal change of ankle-brachial index (ABI) exhibited different patterns between IC and CLTI (pinteraction=0.002), but ABI improved after EVT both in IC and in CLTI (p<0.001), which was sustained over time. Dorsal and plantar skin perfusion pressure in CLTI showed a similar improvement pattern (pinteraction=0.181). Distribution of Rutherford category improved both in IC and in CLTI (each p<0.001). Three-year MACE rates were 20.4% and 42.3% and 3-year reintervention rates were 22.1% and 46.8% for patients with IC and CLTI, respectively (log-rank p<0.001). Elevated D-dimer (p=0.001), age (p=0.043), impaired functional status (p=0.018), and end-stage renal disease (p=0.019) were independently associated with MACE. After considering competing risks of death and major amputation for reintervention, elevated erythrocyte sedimentation rate (p=0.003) and infrainguinal intervention (p=0.002) were independently associated with reintervention. Patients with CLTI merely showed borderline significance for MACE (adjusted hazard ratio 1.700, 95% confidence interval 0.950-3.042, p=0.074) and reintervention (adjusted hazard ratio 1.976, 95% confidence interval 0.999-3.909, p=0.05). CONCLUSIONS: The CLTI is characterized not only by more systemic comorbidities and distal disease but also by more inflammatory coagulation disorder compared with IC. Also, CLTI has approximately twice MACE and reintervention rates than IC, and the underlying inflammatory coagulation disorder per se is associated with these outcomes. CLINICAL IMPACT: The underlying difference between intermittent claudication (IC) and critical limb-threatening ischemia (CLTI) still remains unclear. This prospective multicenter observational study, JPASSION study found that CLTI was characterized not only by more systemic comorbidities and distal disease but also by more inflammatory coagulation disorder compared to IC. Also, CLTI had approximately twice major adverse cardiovascular event (MACE) and reintervention rates than IC. Intriguingly, the underlying inflammatory coagulation disorder per se was independently associated with MACE and reintervention. Further studies to clarify the role of anticoagulation and anti-inflammatory therapies will contribute to the development of post-interventional therapeutics in the context of peripheral artery disease.

Clinical Outcomes of Subcutaneous and Visceral Adipose Tissue Characteristics Assessed in Patients Underwent Transcatheter Aortic Valve Replacement.

BACKGROUND: Adipose tissue (AT) characteristics are considered to be a marker for predicting clinical outcomes. This study aimed to investigate the prognostic value of subcutaneous adipose tissue (SAT) and visceral adipose tissue (VAT) computed tomography (CT) assessment in patients who underwent transcatheter aortic valve replacement (TAVR). METHODS: We used the Japanese multicentre registry data of 1372 patients (age: 84.5 ± 5.0 years, women: 70.6%) who underwent TAVR. The SAT and VAT were assessed according to the preprocedural CT area and density. Baseline characteristics and clinical outcomes were compared based on the differences in AT characteristics. The independent associations with all-cause mortality after TAVR were evaluated according to the CT area and density of AT. RESULTS: Low-volume area of SAT and VAT was associated with worse clinical outcomes compared with high-volume area of SAT and VAT in patients who underwent TAVR (log-rank test P = 0.016 and P = 0.014). High CT density of SAT and VAT was associated with increasing mortality in comparison with low CT density of SAT and VAT (log-rank test P < 0.001 and P = 0.007). The Cox regression multivariate analysis demonstrated the independent association of increased all-cause mortality in the high SAT and VAT density (hazard ratio [HR]: 1.41, 95% confidence interval [CI]: 1.06-1.88, P = 0.019, and HR: 1.34, 95% CI: 1.03-1.76, P = 0.031, respectively), but not in the low SAT and VAT area (HR: 0.85, 95% CI: 0.74-1.29, P = 0.85, and HR: 0.78, 95% CI: 0.60-1.03, P = 0.085, respectively). CONCLUSIONS: CT-derived AT characteristics, particularly the qualitative assessments, were useful for predicting the prognosis in patients after TAVR.

INTRODUCTION: Les caractéristiques du tissu adipeux (TA) sont considérées comme un marqueur de la prédiction des résultats cliniques. La présente étude avait pour objectif d'examiner la valeur pronostique de l'évaluation par tomodensitométrie (TDM) du tissu adipeux sous-cutané (TASC) et du tissu adipeux viscéral (TAV) des patients qui subissaient un remplacement valvulaire aortique par cathéter (RVAC). MÉTHODES: Nous avons utilisé les données du registre multicentrique japonais de 1 372 patients (âge : 84,5 ± 5,0 ans, femmes : 70,6 %) qui subissaient un RVAC. Nous avons évalué le TASC et le TAV selon la surface et la densité à la TDM préinterventionnelle. Nous avons comparé les caractéristiques initiales et les résultats cliniques en nous basant sur les différences dans les caractéristiques du TA. Nous avons évalué les associations indépendantes à la mortalité toutes causes confondues après le RVAC selon la surface et la densité du TA à la TDM. RÉSULTATS: La surface de faible volume du TASC et du TAV était associée à de plus mauvais résultats cliniques que la surface de grand volume du TASC et du TAV chez les patients qui subissaient le RVAC (test logarithmique par rangs P = 0,016 et P = 0,014). La densité du TASC et du TAV à la TDM était associée à l'augmentation de la mortalité en comparaison d'une faible densité du TASC et du TAV à la TDM (test logarithmique par rangs P < 0,001 et P = 0,007). L'analyse multivariée selon le modèle de régression de Cox démontrait l'association indépendante de l'augmentation de la mortalité toutes causes confondues lors de densité élevée du TASC et du TAV (rapport de risque [RR] 1,41, intervalle de confiance [IC] à 95 %, 1,06-1,88, P = 0,019, et RR 1,34, IC à 95 %, 1,03-1,76, P = 0,031, respectivement), mais non lors de faible surface du TASC et du TAV (RR 0,85, IC à 95 %, 0,74-1,29, P = 0,85, et RR 0,78, IC à 95 % : 0,60-1,03, P = 0,085, respectivement). CONCLUSIONS: Les caractéristiques du TA acquises par TDM, particulièrement les évaluations qualitatives, étaient utiles à la prédiction du pronostic des patients après le RVAC.

Changes in cardiac sympathetic nerve activity on 123 I-metaiodobenzylguanidine scintigraphy after MitraClip therapy.

AIMS: In patients with heart failure, over-activation of the cardiac sympathetic nerve (CSN) function is associated with severity of heart failure and worse outcome. The effects of MitraClip therapy on the CSN activity in patients with mitral regurgitation (MR) remained unknown. In this study, we evaluated the impact of the MitraClip therapy on CSN activity assessed by 123 I-metaiodobezylguanidine (MIBG) scintigraphy. METHODS AND RESULTS: We enrolled consecutive patients with moderate-to-severe (3+) or severe (4+) MR who were scheduled to undergo MitraClip procedure in this prospective observational study. MIBG scintigraphy was performed at baseline and 6 months after the MitraClip procedure to evaluate the heart-mediastinum ratio and washout rate (WR). Changes in these MIBG parameters were analysed. Of the 13 consecutive patients, 10 were successfully treated with MitraClip procedure and completed follow-up assessment. With regard to the MIBG parameters, changes in the early and delayed heart-mediastinum ratio from baseline to 6 months were not significant (2.16 ± 0.42 to 2.06 ± 0.34, P = 0.38 and 1.87 ± 0.39 to 1.83 ± 0.39, P = 0.43, respectively), whereas WR was significantly decreased (38.6 ± 3.9% to 32.6 ± 3.94%, P = 0.002). CONCLUSIONS: The CSN activity of the WR on MIBG imaging was improved 6 months after MitraClip therapy in patients with 3+ or 4+ MR.

Midterm outcomes after the rescue THV-in-THV procedure: Insights from the multicenter prospective OCEAN-TAVI registry.

OBJECTIVES: To confirm whether the rescue transcatheter heart valve in the transcatheter heart valve (THV-in-THV) procedure is effective and feasible, we aimed to assess the midterm outcomes following rescue THV-in-THV procedures. The trends in the usage of the rescue THV-in-THV procedure at the time of transcatheter aortic valve implantation (TAVI) have also been explored. BACKGROUND: Midterm outcomes of the rescue THV-in-THV procedure have been poorly defined, though it is popular as an effective method to bail-out some complications in TAVI. METHODS: We reviewed data from the Optimized transCathEter vAlvular iNtervention-Transcatheter Aortic Valve Implantation (OCEAN-TAVI) registry and compared the outcomes of TAVI with rescue THV-in-THV and TAVI without rescue THV-in-THV. We also examined the annual rates of rescue THV-in-THV procedures in all the TAVI procedures between 2013 and 2017. RESULTS: Among 2,588 patients who underwent TAVI, 26 patients have required rescue THV-in-THV for valve malposition (n = 23) or severe transvalvular regurgitation because of stuck THV leaflets (n = 3). Three cases needed an open conversion, and two died in the hospital. The rates of new permanent pacemaker implantation, acute kidney injury, and stroke were higher in the THV-in-THV group. A two-year cumulative survival and echocardiographic outcomes succeeding rescue THV-in-THV procedure were comparable to non-THV-in-THV cases. The rate of rescue THV-in-THV procedure lessened from 2.6% in 2013 to 0.6% in 2017. CONCLUSIONS: The rescue THV-in-THV procedure is an effective and feasible option for THV malpositioning and stuck valve. It has given a comparable survival and a stable valve function over midterm observation periods.

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.

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.

Predictors and Prognostic Impact of Nutritional Changes After Transcatheter Aortic Valve Replacement.

BACKGROUND: Little is known about changes in nutritional status as an index of frailty on clinical outcomes after transcatheter aortic valve replacement (TAVR). This study aimed to assess the clinical impact of serum albumin changes after TAVR. METHODS: Changes in serum albumin levels from baseline to 1 year after TAVR were evaluated in 1524 patients who were classified as having hypoalbuminemia (<3.5 g/dl) and normoalbuminemia (≥3.5 g/dl) at each timepoint. The patients were categorized into 4 groups: NN (baseline normoalbuminemia, 1-year normoalbuminemia: n = 1119), HN (baseline hypoalbuminemia, 1-year normoalbuminemia: n = 202), NH (baseline normoalbuminemia, 1-year hypoalbuminemia: n = 121), and HH (baseline hypoalbuminemia, 1-year hypoalbuminemia: n = 82). We also defined late hypoalbuminemia as hypoalbuminemia identified at the 1-year assessment. Clinical outcomes were compared among 4 groups. Multivariable analysis was driven to assess the variables associated with late hypoalbuminemia and long-term mortality. RESULTS: The cumulative 3-year mortality was significantly different among the 4 groups (NN: 11.4%, HN: 10.7%, NH: 25.4%, HH: 44.4%, p < 0.001). Multivariable Cox regression analysis revealed that the NH group had a higher mortality risk (hazard ratio [HR]; 2.80 and 3.53, 95% confidence interval [CI]; 1.71-4.57 and 2.06-6.06, p < 0.001 and p < 0.001, respectively), whereas the HN group had a similar risk (HR; 1.16, 95% CI; 0.66-2.06, p = 0.61) compared with the NN group. Baseline hypoalbuminemia, low body mass index, liver disease, peripheral artery disease, and hospital readmission within 1 year were predictors of late hypoalbuminemia (all p < 0.05). CONCLUSION: Serial albumin assessment may identify poor prognostic subsets in patients with persistent and late acquired malnutrition after TAVR.

Impact of beta blockers on patients undergoing transcatheter aortic valve replacement: the OCEAN-TAVI registry.

OBJECTIVE: 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.

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

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

Appropriateness of Transcatheter Aortic Valve Replacement: Insight From the OCEAN-TAVI Registry.

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is widely used; however, its appropriateness is unknown. We sought to investigate the appropriateness of TAVR. METHODS AND RESULTS: We assigned appropriateness ratings to patients undergoing TAVR for severe aortic stenosis between October 2013 and May 2017 at 14 Japanese hospitals participating in the optimized transcatheter valvular intervention-transcatheter aortic valve implantation registry according to the US appropriate use criteria for treating severe aortic stenosis. To account for the influence of uncaptured variables on appropriate use criteria ratings, we initially assigned them to a best-case scenario where they were assumed to classify a case to the most appropriate clinical scenario and then to a worst-case scenario where assumed least appropriate. Overall proportion of TAVRs classified as appropriate, maybe appropriate, or rarely appropriate was assessed. In addition, extent of hospital-level variation in rarely appropriate procedures was evaluated. Of 2036 TAVRs (median age [25th, 75th]: 85.0 years [81.0-88.0]; 70.5% female the Society of Thoracic Surgeons Predicted Risk of Mortality score: 6.2% [4.4-8.9]), in the best-case scenario, 177 (8.7%) were not successfully mapped, and 1580 (77.6%) were classified as appropriate, 180 (8.8%) as maybe appropriate, 99 (4.9%) as rarely appropriate, respectively. In the worst-case scenario, the rate of rarely appropriate increased to 6.8%. The majority of rarely appropriate TAVRs was performed in patients with moderate to severe dementia (defined as mini-mental status examination of ≤17), bicuspid aortic valve, or anticipated life expectancy <1 year. There was substantial variation in the proportion of rarely appropriate TAVR across hospitals (median rate of rarely appropriate: 4.9% [3.8-6.6] in the best-case scenario, P<0.001; 6.5% [5.6-8.6] in the worst-case scenario, P<0.001). CONCLUSIONS: In clinical practice, the proportion of rarely appropriate TAVRs ranged from 4.9% to 6.8% with substantial institutional variation. Our study elucidates common clinical scenarios deemed rarely appropriate and clarifies the potential targets of quality improvement. Registration: URL: https://www.umin.ac.jp/ctr/index.htm. Unique identifier: UMIN000020423.

Importance of combined assessment of skeletal muscle mass and density by computed tomography in predicting clinical outcomes after transcatheter aortic valve replacement.

Skeletal muscle mass (SMM) as calculated by computed tomography (CT) is a predictor of all-cause mortality after transcatheter aortic valve replacement (TAVR), but it remains unclear whether using CT-determined density of skeletal muscle has additive prognostic value. We utilized the Japanese multicenter registry data of 1375 patients who underwent CT prior to TAVR. Sarcopenia status was defined by the CT-derived SMM index (threshold: men, 55.4 cm2/m2; women, 38.9 cm2/m2). The threshold for high and low CT density was based on the median value of the entire cohort (men: 33.4 HU; women: 29.5 HU). Sarcopenia was observed in 802 patients (58.3%) overall. Patients were categorized into non-sarcopenia and high-CT density (n = 298), non-sarcopenia and low-CT density (n = 275), sarcopenia and high-CT density (n = 399), and sarcopenia and low-CT density (n = 403) groups, and procedural outcomes and mortality compared. The cumulative 3-year mortality rates in these groups were 18%, 27%, 24%, and 32%, respectively. Cox-regression multivariate analysis revealed that low-CT density (compared with high-CT density) and sarcopenia and low-CT density (compared with non-sarcopenia and high-CT density as reference) increased mortality after TAVR (hazard ratios [HR]: 1.35 and 1.43, 95% confidence intervals [Cis]: 1.06-1.72 and 1.00-2.08, p = 0.01, and 0.049, respectively). However, sarcopenia alone was not related to an increased risk of mortality (HR 1.30, 95% CI 0.99-1.69, p = 0.52). In conclusion, CT density-based skeletal muscle quality assessment combined with the SMM index improves prediction of adverse outcomes after TAVR.

Percutaneous Aortic Valve Intervention in Patients Scheduled for Noncardiac Surgery: A Japanese Multicenter Study.

BACKGROUND: The optimal management of preexisting severe aortic stenosis (AS) in patients undergoing noncardiac surgery (non-CS) remains uncertain. This study aimed to investigate the safety and effectiveness of percutaneous aortic valve intervention (PAVI) in patients with AS before non-CS. METHODS: We analyzed pooled data within a multicenter Japanese registry from 118 patients with severe AS who underwent PAVI before non-CS. Sixty patients underwent percutaneous balloon aortic valvuloplasty (BAV) and 58 patients underwent transcatheter aortic valve replacement (TAVR). The groups' baseline characteristics, perioperative complications, and 30-day mortality and midterm mortality after non-CS were compared. RESULTS: The postprocedural mean pressure gradient was higher in the BAV group than in the TAVR group (35.0 ±â€¯11.5 mmHg vs. 11.5 ±â€¯4.8 mmHg, p < 0.001). The non-CS operation risk did not differ between the groups (p = 0.69). One patient in each group experienced a noncardiac death (p = 0.74), and the 30-day mortality rate after non-CS was 1.7%. Heart failure occurred in 2 patients in each group (p = 0.68). One patient in the TAVR group experienced a non-disabling stroke, and no myocardial infarctions occurred. Consequently, the combined adverse events were 5.0% and 6.9% in the 2 groups (p = 0.48). The bleeding rates during the non-CS were similar in both groups (33.3% vs. 25.9%, p = 0.25). There were no differences between the groups regarding midterm mortality (p = 0.60), whereas 53.3% of the patients in the BAV group required invasive treatment of their AS during follow-up. CONCLUSIONS: Among patients with severe AS, PAVI before non-CS reduces the AS severity and may contribute to procedural safety during non-CS.

The Predictors of Peri-Procedural and Sub-Acute Cerebrovascular Events Following TAVR from OCEAN-TAVI Registry.

BACKGROUND: Cerebrovascular events (CVEs) are not uncommon complications of transcatheter aortic valve replacement (TAVR). Our study aimed to determine the predictors of peri-procedural and sub-acute CVEs following TAVR. METHODS: Using the Japanese multicenter registry, we evaluated 1613 patients undergoing TAVR between October-2013 and July-2016. Occurrences of 24-hour and 1- to 30-day CVEs were evaluated to clarify the predictors of CVEs following TAVR. RESULTS: The mean age was 84.4 years and mean Society of Thoracic Surgeons score was 8.3%. Overall 24-hour and 30-day CVE rates were 1.2% and 2.7%, respectively. A multivariate analysis demonstrated that independent predictor of 24-hour CVEs was index aortic valve area (iAVA) [adjusted OR (adjusted-OR), 0.001; 95% CI, 0.001-0.13; p = .005]. The receiver operator curve derived cut-off value of iAVA for the prediction of 24-hour CVEs was 0.40 cm2/m2. In contrast, independent predictors of 1- to 30-day CVEs were paroxysmal atrial fibrillation (PAF; adjusted-OR, 3.35; 95% CI, 1.36-8.27; p = .009) and iAVA after TAVR (adjusted-OR, 0.11; 95% CI, 0.02-0.66; p = .02). Consequently, independent predictors of 30-day CVEs were prior stroke (adjusted-OR, 2.18; 95% CI, 1.07-4.45; p = .03), PAF (adjusted-OR, 2.18; 95% CI, 1.05-4.56; p = .04), and prior coronary artery disease (adjusted-OR, 1.88; 95% CI, 1.01-3.48; p = .05). CONCLUSIONS: Within 24 h, small iAVA impacted the increased risk of CVEs, whereas PAF and iAVA after TAVR impacted the increased risk of 1- to 30-day CVEs following TAVR. The mechanism of CVEs might differ according to onset.

Update on the clinical impact of mild aortic regurgitation after transcatheter aortic valve implantation: Insights from the Japanese multicenter OCEAN-TAVI registry.

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

Prognostic impact and periprocedural complications of chronic steroid therapy in patients following transcatheter aortic valve replacement: Propensity-matched analysis from the Japanese OCEAN registry.

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

Peak systolic velocity ratio derived from quantitative vessel analysis for restenosis after femoropopliteal intervention: a multidisciplinary review from Endovascular Asia.

With technological improvements in the endovascular armamentarium, there have been tremendous advances in catheter-based femoropopliteal artery intervention during the last decade. However, standardization of the methodology for assessing outcomes has been underappreciated, and unvalidated peak systolic velocity ratios (PSVRs) of 2.0, 2.4, and 2.5 on duplex ultrasonography have been arbitrarily but routinely used for assessing restenosis. Quantitative vessel analysis (QVA) is a widely accepted method to identify restenosis in a broad spectrum of cardiovascular interventions, and PSVR needs to be validated by QVA. This multidisciplinary review is intended to disseminate the importance of QVA and a validated PSVR based on QVA for binary restenosis in contemporary femoropopliteal intervention.

Previously implanted mitral surgical prosthesis in patients undergoing transcatheter aortic valve implantation: Procedural outcome and morphologic assessment using multidetector computed tomography.

Transcatheter aortic valve implantation (TAVI) in the presence of a preexisting mitral prosthesis is challenging and its influence on the morphology of mitral prosthesis and the positioning of transcatheter heart valve (THV) is unknown. We assessed the feasibility of TAVI for patients with preexisting mitral prostheses, its influence on mitral prosthesis morphology, and the positional interaction between a newly implanted THV and mitral prosthesis using serial multidetector computed tomography (MDCT). Thirty-one patients with preexisting mitral prosthesis undergoing TAVI were included. MDCT was performed before and after TAVI. Thirty patients successfully underwent TAVI without interference from preexisting mitral prosthesis. Although opening disturbance of the mechanical mitral prosthesis by the THV edge was observed in 1 patient, the patient was managed conservatively. No THV embolization occurred. THV shift during deployment occurred in 9 patients and was predicted by a larger aortic annulus area (odds ratio: 1.24 per 10 mm2, 1.03-1.49, p = 0.02), possibly because of large THVs. The mitral mean pressure gradient was slightly higher after TAVI (3.7 vs. 4.3 mmHg, p = 0.002), whereas the mitral regurgitation grade was similar. MDCT showed that the size of the mitral prosthesis housing was unchanged after TAVI. The median distance between the mitral prosthesis and THV was 2.6 mm. The postprocedural angle between the mitral prosthesis and THV was larger than the preprocedural angle between the mitral prosthesis and the left ventricular outflow tract (64° vs. 61°, p = 0.03). Thus, TAVI is feasible in the case of preexisting mitral prosthesis. Serial MDCT demonstrated favorable THV positioning and unchanged mitral prosthesis morphology after TAVI.

Silent Valsalva thrombus between the native Valsalva and balloon-expandable transcatheter heart valve: multicentre Japanese registry analysis.

AIMS: The newly formed geometry between the native Valsalva and implanted transcatheter heart valve (THV) may induce local thrombogenicity. This study aimed to assess the incidence of and the clinical outcomes associated with Valsalva thrombus formation after transcatheter aortic valve implantation (TAVI). METHODS AND RESULTS: We retrospectively evaluated the multidetector computed tomography (MDCT) data of 338 patients following transcatheter aortic valve implantation (TAVI) using a balloon-expandable THV. The Valsalva and leaflet thrombi were assessed by MDCT at the left coronary cusp (LCC), right coronary cusp (RCC), and non-coronary cusp (NCC). Combined endpoints such as death, stroke, and readmission for heart failure rates in patients with and without Valsalva and/or leaflet thrombus were examined at two years. The overall incidence of Valsalva and leaflet thrombi was 8.9% and 8.3%, respectively. Significant differences in the location of the Valsalva thrombus in the LCC, RCC, and NCC were noted (5.0%, 4.2%, 8.9%, respectively, p<0.001). The independent predictor for increased risk of Valsalva thrombus was high Valsalva area to implanted THV size ratio (odds ratio 11.8, 95% confidence interval [CI]: 1.67-83.0, p=0.013). Combined endpoints were similar in patients with and without Valsalva thrombus, Valsalva/leaflet thrombus, and leaflet thrombus (p>0.05 for all). CONCLUSIONS: Valsalva thrombus was detected in 8.9% of patients following balloon-expandable THV implantation and was common in the LCC, but it did not increase the risk of adverse events after TAVI.

Prognostic impact of postprocedure stroke volume in patients with low-gradient aortic stenosis.

Objective: 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/m2 decrease; HR, 2.0; 95% CI 1.28 to 3.12). The optimal cut-off value of post-TAVI SVi was 41.4 mL/m2. 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/m2) require careful management after TAVI.