Validation of reliability and predictivity of membrane septum length measurements for pacemaker need after transcatheter aortic valve replacement.

OBJECTIVES: To assess the inter methodological agreement of membrane septum (MS) length measurement and additive value for risk stratification of new pacemaker implantation (PMI) over the established predictors after transcatheter aortic valve replacement (TAVR). BACKGROUND: Recent studies have suggested MS length and implantation depth (ID) as predictors for PMI after TAVR. However, the measurement of MS length is neither uniform nor validated in different cohort. METHODS: We retrospectively analyzed patients who underwent TAVR at five centers. The MS length was measured by two previously proposed methods (coronal and annular view method). Predictive ability of risk factors, including MS length and ID, for new PMI within 30 days after TAVR were evaluated. RESULTS: Among 754 patients of study population, 31 patients (4.1%) required new PMI within 30 days of TAVR. There was a weak correlation (ρ = 0.47) and a poor agreement between the two methods. The ID and the difference between MS length and ID (ΔMSID), were independent predictors for new PMI, whereas MS length alone was not. Further, for predicting new PMI after TAVR, discrimination performance was not significantly improved when MS length was added to the model with ID alone (integrated discrimination improvement = 0, p= 0.99; continuous net-reclassification improvement = 0.10, p= 0.62). CONCLUSIONS: External validity and predictive accuracy of MS length for PMI after TAVR were not sufficient to provide better risk stratification over the established predictors in our cohort. Moreover, the ID and ΔMSID, but not MS length alone, are predictive of future PMI after TAVR.

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.

Calculated plasma volume status and outcomes in patients undergoing transcatheter aortic valve replacement.

AIMS: This study investigated the prognostic value of plasma volume status (PVS) in patients who underwent transcatheter aortic valve replacement (TAVR). METHODS AND RESULTS: Plasma volume status was calculated in 2588 patients who underwent TAVR using data from the Japanese multicentre registry. All-cause mortality and heart failure hospitalization (HFH) within 2 years of TAVR were compared among the PVS quartiles (Q1, PVS < 5.5%; Q2, PVS 5.5-13.5%; Q3, PVS 13.5-21.0%; and Q4, PVS ≥ 21.0%). Subgroups were stratified by the PVS cut-off value combined with the New York Heart Association (NYHA) class as follows: low PVS with NYHA I/II (n = 959), low PVS with NYHA III/IV (n = 845), high PVS with NYHA I/II (n = 308), and high PVS with NYHA III/IV (n = 476). The cumulative all-cause mortality and HFH within 2 years of TAVR significantly increased with increasing PVS quartiles [8.5%, 16.8%, 19.2%, and 27.0% (P < 0.001) and 5.8%, 8.7%, 10.3%, and 12.9% (P < 0.001), respectively]. The high-PVS group regardless of the NYHA class had a higher all-cause mortality and HFH [9.6%, 18.2%, 24.5%, and 30.4% (P < 0.001) and 6.1%, 10.4%, 14.1%, and 11.3% (P < 0.001)]. In a Cox regression multivariate analysis, the PVS values of Q3 and Q4 had independently increased all-cause mortality [hazard ratio (HR), 1.50 and 1.64 (P = 0.017 and P = 0.008), respectively], and Q4 had independently increased HFH (HR, 1.98, P = 0.005). The low PVS with NYHA III/IV, high PVS with NYHA I/II, and high PVS with NYHA III/IV also had significantly increased all-cause mortality [HR, 1.45, 1.73, and 1.86 (P = 0.006, P = 0.002, and P < 0.001), respectively] and HFH [HR, 1.52, 2.21, and 1.70 (P = 0.049, P = 0.002, and P = 0.031), respectively]. CONCLUSIONS: Plasma volume status is useful for predicting all-cause mortality and HFH after TAVR.

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.

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 Value of Hypoalbuminemia After Transcatheter Aortic Valve Implantation (from the Japanese Multicenter OCEAN-TAVI Registry).

Hypoalbuminemia, a frailty criterion, belongs to a group of co-morbidities not captured as a traditional risk factor. We assessed its prognostic value in patients who underwent transcatheter aortic valve implantation (TAVI). The study included 1,215 consecutive patients from the Optimized Catheter Valvular Intervention -TAVI Japanese multicenter registry. Hypoalbuminemia was defined as serum albumin level <3.5 g/dl. Baseline characteristics, procedural outcomes, and all-cause, cardiovascular and noncardiovascular mortality rates after TAVI were compared between patients with albumin level <3.5 g/dl (hypo[h]-ALB group, n = 284) and those with albumin level >3.5 g/dl (nonhypo[nh]-ALB group, n = 931). Several baseline characteristics differed significantly between both groups, including age (85.1 ± 5.1 vs 84.2 ± 4.9 years, p = 0.012), ejection fraction (58.5 ± 14.3% vs 62.9 ± 12.4%, p <0.001), baseline kidney function, or liver disease. The 30-day mortality rate in all patients showed significant differences between the 2 groups (3.9% vs 1.3%, p = 0.005). During a mean follow-up of 330 days, cumulative all-cause, cardiovascular, and noncardiovascular mortality rates were significantly higher in the hALB group than in the nhALB group (log-rank test, p <0.001, p = 0.0021, and p <0.001, respectively). The groups were also analyzed using a propensity matching model for adjusting the baseline differences. The analysis revealed that the poorer prognosis of the hALB group in terms of cumulative all-cause and noncardiovascular mortality was retained (p = 0.038, and p = 0.0068, respectively); however, differences in cardiovascular mortality rates in the 2 groups were attenuated (p = 0.93). In conclusion, hypoalbuminemia was associated with poor prognosis, highlighted by the increase in noncardiovascular mortality. Baseline albumin level could be a useful marker for risk stratification before TAVI.