Impact of Extravascular Ultrasound-Guided Wiring on Achieving Optimal Vessel Preparation and Patency in Endovascular Therapy for Superficial Femoral Artery Chronic Total Occlusion.

PURPOSE: The study aim was to evaluate the impact of extravascular ultrasound-guided (EVUSG) wiring on achieving optimal vessel preparation and patency in endovascular therapy (EVT) for superficial femoral artery (SFA) chronic total occlusion (CTO). METHODS: Between April 2007 and January 2019, a total of 239 SFA-CTO limbs were successfully treated with EVT and bailout implantation of self-expandable nitinol stents at our hospital. The study subjects were divided into 2 groups according to the type of guidance strategy used during CTO wiring, ie, the EVUSG group and the conventional angiography guidance (AG) group. Immediately after the initial balloon angioplasty and successful passage of the wire through the SFA-CTO lesions, the EVUSG (65 limbs) and AG groups (174 limbs) were retrospectively evaluated for angiographic dissection patterns. The primary patency rate was also compared between the 2 groups. RESULTS: No significant difference was observed in the balloon diameter at the initial dilation immediately after successful wire passing (3.7 ± 0.5 mm in the EVUSG group vs 3.8 ± 0.5 mm in the AG group; P=.17). The incidence of severe dissection was significantly lower (P<.001) in the EVUSG group (28/65; 43%) than in the AG group (137/174; 79%). The 3-year primary patency rates in the EVUSG and AG groups were 84.5% and 68.4%, respectively (P<.001). CONCLUSIONS: EVUSG for SFA-CTO may achieve optimal vessel preparation, defined as an initial balloon angioplasty without severe dissection, and subsequent implantation of self-expandable stents may lead to a better patency rate.

Prognostic Value of Ventricular-Arterial Coupling After Transcatheter Aortic Valve Replacement on Midterm Clinical Outcomes.

Background Ventricular-arterial coupling predicts outcomes in patients with heart failure. The arterial elastance to end-systolic elastance ratio (Ea/Ees) is a noninvasively assessed index that reflects ventricular-arterial coupling. We aimed to determine the prognostic value of ventricular-arterial coupling assessed through Ea/Ees after transcatheter aortic valve replacement to predict clinical events. Methods and Results We retrieved data on 1378 patients (70% women) who underwent transcatheter aortic valve replacement between October 2013 and May 2017 from the OCEAN-TAVI (Optimized transCathEter vAlvular iNtervention) Japanese multicenter registry. We determined the association between Ea/Ees and the composite end point of hospitalization for heart failure and cardiovascular death by classifying the patients into quartiles based on Ea/Ees values (group 1: <0.326; group 2: 0.326-0.453; group 3: 0.453-0.666; and group 4: >0.666) during the midterm follow-up after transcatheter aortic valve replacement. During a median follow-up period of 736 days (interquartile range, 414-956), there were 247 (17.9%) all-cause deaths, 89 (6.5%) cardiovascular deaths, 130 (9.4%) hospitalizations for heart failure, and 199 (14.4%) composite events of hospitalization for heart failure and cardiovascular death. The incidence of the composite end point was significantly higher in group 2 (hazard ratio [HR], 1.76; 95% CI, 1.08-2.87 [P=0.024]), group 3 (HR, 2.43; 95% CI, 1.53-3.86 [P<0.001]), and group 4 (HR, 2.89; 95% CI, 1.83-4.57 [P<0.001]) than that in group 1. On adjusted multivariable Cox analysis, Ea/Ees was significantly associated with composite events (HR, 1.47 per 1-unit increase; 95% CI, 1.08-2.01 [P=0.015]). Conclusions These findings suggest that a higher Ea/Ees at discharge after transcatheter aortic valve replacement is associated with adverse clinical outcomes during midterm follow-up. Registration URL: https://www.upload.umin.ac.jp/. Unique identifier: UMIN000020423.

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.

Frequency, predictors, and effect of the slow-flow phenomenon after drug-coated balloon angioplasty for femoropopliteal lesions.

Drug-coated balloon (DCB) angioplasty for femoropopliteal (FP) lesions has been available in Japan since 2018. In daily practice, we encountered cases of the slow-flow phenomenon after DCB angioplasty. However, no data regarding the slow-flow phenomenon after DCB angioplasty for FP lesions are available. This study aimed to investigate the frequency, predictors, and effect of the slow-flow phenomenon following DCB angioplasty for FP lesions. This single-center, retrospective, observational study analyzed 88 FP lesions treated by DCB angioplasty between April 2018 and July 2019. Patients were divided into the slow-flow group (n = 7) and non-slow-flow group (n = 81) and were analyzed. The primary endpoint was primary patency at 6 months. The slow-flow phenomenon was observed in seven cases (8.0%). The slow-flow group had higher incidence rates of critical limb ischemia (CLI) (71% vs. 25%, p < 0.01), chronic total occlusion (CTO) lesions (86% vs. 26%, p < 0.01), and poor tibial vessel runoff (86% vs. 33%, p < 0.01) and had a longer DCB length (237 ± 56 mm vs. 159 ± 97 mm, p = 0.03) than the non-slow-flow group. The primary patency rate at 6 months was 71% in the slow-flow group and 91% in the non-slow-flow group (p = 0.09). The rate of freedom from target lesion revascularization at 6 months was 71% in the slow-flow group and 97% in the non-slow-flow group (p < 0.01). The amputation-free survival rate at 6 months was 71% and 95% (p = 0.02), whereas the survival rate at 6 months was 71% and 95% (p = 0.02). The incidence rate of the slow-flow phenomenon after DCB angioplasty for FP lesions was 8.0%. CLI, a CTO lesion, poor tibial vessel runoff, and total DCB length were associated with the slow-flow phenomenon. Our results indicate that the slow-flow phenomenon is associated with poor short-term clinical outcomes.

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.

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.

Atrial Fibrillation is Associated with Femoropopliteal Totally Occlusive In-Stent Restenosis: A Single-Center, Retrospective, Observational Study.

INTRODUCTION: The proportion of patients with comorbid atrial fibrillation (AF) and peripheral artery disease (PAD) has increased in this era. This study aimed to assess the relationship between AF and totally occlusive in-stent restenosis (ISR) in femoropopliteal (FP) lesions. METHODS: In this study, 363 patients (461 stents) who underwent endovascular therapy with de novo stent implantation in our hospital between April 2007 and December 2016 were retrospectively evaluated. The patients were divided into two groups according to the AF status (AF group, 61 patients; sinus group, 302 patients). The primary endpoint was the incidence of totally occlusive ISR within 3 years. The secondary endpoint was the incidence of acute limb ischemia (ALI) due to FP stent occlusion. RESULTS: Baseline characteristics were similar, except for higher age and a lower prevalence of dyslipidemia in the AF group. The incidence of a totally occlusive ISR was higher in the AF group than in the sinus group (29.5% vs. 14.6%, p=0.004). A multiple Cox regression model suggested that presence of AF (hazard ratio, 2.10) and CTO lesion (hazard ratio, 1.97) which were the independent predictors of a totally occlusive ISR within 3 years. The incidence of ALI was significantly higher in the AF group than in the sinus group (3.9% vs. 0%, p=0.0001). In the AF group, the introduction of an anticoagulant did not prevent the occurrence of totally occlusive ISR (p=0.71) for ALI (p=0.79). CONCLUSIONS: AF is independently associated with totally occlusive ISR of FP stents; however, anticoagulant use does not prevent stent occlusion.

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.

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.

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.

A novel technique to avoid perforation of the right ventricle by the temporary pacing lead during transcatheter aortic valve implantation.

Cardiac tamponade is a life-threatening complication during transcatheter aortic valve implantation (TAVI), often caused by perforation of the right ventricle (RV) by the temporary pacemaker used for rapid pacing during valve deployment. We aimed to assess the feasibility of performing rapid pacing while maintaining inflation of the pacing lead balloon in the RV during TAVI. Among 749 consecutive patients who underwent TAVI with SAPIEN XT valves between October 2013 and July 2015, 726 treated using rapid pacing with a transvenous balloon-tip lead were enrolled in our study, and were stratified into three groups according to the extent of balloon inflation in the RV as follows: full inflation (n = 100), partial inflation (n = 196), and deflation (n = 430). We compared the following clinical outcomes: pacing lead-related RV perforation, rapid pacing failure, valve malpositioning due to rapid pacing failure, device success, and 30-day mortality. Pacing lead-related RV perforation occurred only in patients in the deflation group (6 cases, 1.4%), but the differences among the groups were not statistically significant (p = 0.13). Rapid pacing failure, but no valve malpositioning, occurred most frequently in patients in the full inflation group (4.0% vs. 0.5% in the other groups, p = 0.004). The rate of device success (> 94%) and the 30-day mortality (2.0%) were similar among the three groups. Partial inflation of the balloon of the pacing lead may reduce the risk of RV perforation without increasing the risk of pacing failure or valve malpositioning.

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.

Evaluation of the incidence, timing, and potential recovery rates of complete atrioventricular block after transcatheter aortic valve implantation: a Japanese multicenter registry study.

Data on the accurate onset date and serial changes of the complete atrioventricular block (CAVB) after transcatheter aortic valve implantation (TAVI) are limited. This study aimed to assess the incidence, timing, and potential recovery of CAVB following TAVI. Total 696 patients who underwent TAVI were enrolled. Acute CAVB was evaluated within 24 h; delayed CAVB was evaluated 24 h after TAVI. Recovered CAVB was defined as ventricular pacing < 1% during the follow-up or transit block without the need for permanent pacemaker implantation (PMI). The other patients with CAVB were categorized as continued CAVB. Clinical differences between the recovered and continued CAVB groups were evaluated, and the predictive factors of continued CAVB were assessed. The incidence rates of CAVB, acute CAVB, and delayed CAVB were 6.9% (48/696), 4.6% (32/696), and 2.3% (16/696), respectively. Overall, 47.9% (23/48) of patients had recovered CAVB, which was more prevalent in the acute CAVB group than in the delayed CAVB group [59.4% (19/32) vs. 25.0% (4/16), p = 0.025]. CAVB recovery occurred within 24 h (61.0%, 14/23) and after 24 h (39.0%, 9/23). Before CAVB recovery, 21.7% (5/23) of patients had already undergone PMI. A pre-existing complete right bundle branch block (CRBBB) was the only independent predictive factor of continued CAVB (odds ratio 4.51, 95% confidence interval 1.03-19.6, p = 0.045). In conclusion, a pre-existing CRBBB and the timing and prolonged duration of CAVB may be used in risk stratification to determine the appropriateness of early discharge, optimal PMI date, and PMI indication.

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.

Late Adverse Cardiorenal Events of Catheter Procedure-Related Acute Kidney Injury After Transcatheter Aortic Valve Implantation.

Data regarding the longitudinal effect of catheter procedure-related acute kidney injury (AKI) on clinical outcomes are limited. This study aimed to assess the late adverse cardiorenal events of AKI following transcatheter aortic valve implantation (TAVI). A total of 2,518 patients who underwent TAVI, excluding in-hospital deaths, were enrolled from the Japanese multicenter registry. The definition of AKI was determined using the Valve Academic Research Consortium-2 criteria. The incidence, predictors, major adverse renal and cardiac events (MARCE), and all-cause mortality of AKI were evaluated. MARCE included readmission for renal and heart failure (HF), hemodialysis requirement, and cardiovascular-renal death during the follow-up period. The incidence of AKI was 9.7% in the entire cohort. The significant predictive factors of AKI were men, diabetes mellitus, hypertension, chronic kidney disease, low albumin, overdose of contrast media, nontransfemoral approach, transfusion, vascular complications, and new pacemaker implantation. The rates of HF readmission and future hemodialysis were significantly higher in patients with AKI than in those without AKI (19.7% vs 9.0%, p <0.001, 3.3% vs 0.4%, p <0.001, respectively). Cox regression multivariate analysis showed that AKI occurrence was an independent predictive factor for the incremental risk of both MARCE and late mortality up to 4 years (hazard ratio [HR] 1.59, 95% confidence interval [CI] 0.75 to 1.20, p <0.001, HR 2.18, 95% CI 1.70 to 2.79; p <0.001, respectively). In conclusion, AKI occurrence was significantly associated with late adverse cardiorenal events after TAVI. Adequate clinical management can be expected to reduce AKI-related late phase cardiorenal damage even after successful TAVI.

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.

Use of the orbital atherectomy system backed up with the guide-extension catheter for a severely tortuous calcified coronary lesion.

A 68-year-old man was scheduled to undergo percutaneous coronary intervention for in-stent total occlusion of the severely tortuous right coronary artery. Intravascular ultrasound revealed heavy in-stent calcification. Lesion atherectomy was required; however, severe proximal vessel tortuosity was detected. We introduced a 7-Fr guide-extension catheter beyond the severely tortuous part and performed rotational atherectomy with a 1.5 mm burr. However, the balloon could not expand; therefore, we changed to an orbital atherectomy system. Subsequently, the balloon successfully expanded, and intravascular ultrasound revealed an enlarged lumen. Severe proximal vessel tortuosity limits the use of atherectomy devices; however, a guide-extension catheter delivers the atherectomy device beyond the tortuosity. The delivery of the orbital atherectomy system inside the guide-extension catheter is easy due to its low profile; the debulking effect increases with the number of passes and rotational speed. This strategy is a useful option for treating severe calcified lesions with proximal vessel tortuosity.

Additional debulking efficacy of low-speed rotational atherectomy after high-speed rotational atherectomy for calcified coronary lesion.

We aimed to evaluate the additional debulking efficacy of low-speed rotational atherectomy (RA) after high-speed RA by using intravascular imaging. A total of 22 severe calcified coronary lesions in 19 patients (age, 74 ± 10 years; 74% male) were retrospectively analyzed. All of these lesions underwent RA under optical coherence tomography (OCT) or optical frequency domain imaging (OFDI) guidance. At first, we performed high-speed RA with 220,000 rpm until the reduction of rotational speed disappeared; then, low-speed RA with 120,000 rpm using the same burr size was performed. OCT or OFDI was performed after both high-speed and low-speed RAs, and the minimum lumen area were compared. The initial and final burr sizes of high-speed RA were 1.5 (1.5-1.75) and 1.75 (1.5-2.0) mm, respectively. The number of sessions, total duration time, and maximum decreased rotational speed during high-speed RA were 11 ± 5 times, 113 ± 47 s, and 4000 (3000-5000) rpm, respectively. During low-speed RA, the number of sessions, total duration time, and maximum reduction of rotational speed were 3 ± 1 times, 32 ± 11 s, and 1000 (0-2000) rpm, respectively. The minimum lumen area was similar between after high-speed and after low-speed RA [2.61 ± 1.03 mm2 (after high-speed RA) vs. 2.65 ± 1.00 mm2 (after low-speed RA); P = 0.91]. Additional low-speed RA immediately after sufficient debulking by high-speed RA was not associated with increased lumen enlargement. There was no clinical efficacy of low-speed RA after high-speed RA.