Longitudinal changes in skin perfusion pressure after endovascular therapy in patients with chronic limb-threatening ischemia.

PURPOSE: The skin perfusion pressure (SPP) increases after endovascular treatment (EVT) for up to 1 month, although changes beyond 1 month remain unreported. This study aimed to investigate the changes in the SPP over time after EVT. MATERIALS AND METHODS: This was a single-center, prospective, observational study. We included patients with chronic limb-threatening ischemia who underwent EVT between January 2019 and July 2022. We evaluated the SPP after EVT monthly for up to 3 months and compared the changes in the SPP between patients with different comorbidities. Moreover, we investigated the independent predictors of recurrent foot ischemia using a multivariate analysis. RESULTS: Overall, 87 patients were included in the study. The mean preprocedural dorsal and plantar SPP was 33.9 ± 14.7 and 33.4 ± 13.1 mmHg, respectively. After the procedure, the SPP significantly increased at 1 month but decreased during months 2 and 3 (the dorsal SPP at 1, 2, and 3 months was 59.6 ± 20.3, 48.3 ± 20.9, and 39.7 ± 14.7, respectively, p < 0.01; the plantar SPP at 1, 2, and 3 months was 57.3 ± 18.2, 48.2 ± 15.6, and 40.5 ± 15.3, respectively, p < 0.01). Changes in the SPP did not differ among patients with different comorbidities. The multivariate analysis revealed that severe infrapopliteal calcification was an independent predictor of recurrent foot ischemia (odds ratio, 3.8; 95% confidence interval, 1.1-13.4; p = 0.04). CONCLUSION: The SPP after EVT significantly increased at 1 month and decreased monthly for up to 3 months. Severe infrapopliteal calcification was the sole predictor of foot ischemia recurrence. Meticulous follow-up after EVT and regular hemodynamic examinations are important.

Feasibility and impact of extra-vascular ultrasound-guided endovascular treatment for infrapopliteal artery occlusive disease.

PURPOSE: This study aimed to examine the feasibility and impact of extra-vascular ultrasound (EVUS)-guided intervention for infrapopliteal (IP) artery occlusive disease. MATERIALS AND METHODS: A retrospective analysis was performed using data collected from patients who underwent endovascular treatment (EVT) for IP artery occlusive disease between January 2018 and December 2020 at our institution. A total of 63 consecutive de novoocclusive lesions were compared according to the recanalization method utilized. Propensity score matching analysis was performed to compare the clinical outcomes of the methods utilized. The prognostic value was analyzed based on the technical success rate, distal puncture rate, radiation exposure, amount of contrast media, postprocedural skin perfusion pressure (SPP), and procedural complication rate. RESULTS: Eighteen matched pairs of patients were analyzed using propensity score-matched analysis. Radiation exposure was significantly lower in the EVUS-guided group than in the angio-guided group, with 135 and 287 mGy (p = 0.04) exposure on average, respectively. There were no significant differences between the two groups in terms of technical success rate, distal puncture rate, the amount of contrast media, postprocedural SPP, and procedural complication rate. CONCLUSION: EVUS-guided EVT for IP occlusive disease achieved a feasible technical success rate and significantly reduced radiation exposure.

Coronary Obstruction From TAVR in Native Aortic Stenosis: Development and Validation of Multivariate Prediction Model.

BACKGROUND: Transcatheter aortic valve replacement (TAVR)-related coronary artery obstruction prediction remains unsatisfactory despite high mortality and novel preventive therapies. OBJECTIVES: This study sought to develop a predictive model for TAVR-related coronary obstruction in native aortic stenosis. METHODS: Preprocedure computed tomography and fluoroscopy images of patients in whom TAVR caused coronary artery obstruction were collected. Central laboratories made measurements, which were compared with unobstructed patients from a single-center database. A multivariate model was developed and validated against a 1:1 propensity-matched subselection of the unobstructed cohort. RESULTS: Sixty patients with angiographically confirmed coronary obstruction and 1,381 without obstruction were included. In-hospital death was higher in the obstruction cohort (26.7% vs 0.7%; P < 0.001). Annular area and perimeter, coronary height, sinus width, and sinotubular junction height and width were all significantly smaller in the obstructed cohort. Obstruction was most common on the left side (78.3%) and at the level of the coronary artery ostium (92.1%). Coronary artery height and sinus width, but not annulus area, were significant risk factors for obstruction by logistic regression but performed poorly in predicting obstruction. The new multivariate model (coronary obstruction IF cusp height > coronary height, AND virtual valve-to-coronary distance ≤4 mm OR culprit leaflet calcium volume >600 mm3) performed well, with an area under the curve of 0.93 (sensitivity = 0.93, specificity = 0.84) for the left coronary artery and 0.94 (sensitivity = 0.92, specificity = 0.96) for the right. CONCLUSIONS: A novel computed tomography-based multivariate prediction model that can be implemented routinely in real-world practice predicted coronary artery obstruction from TAVR in native aortic stenosis.

Incidence, Timing, and Causes of Late Bleeding After TAVR in an Asian Cohort.

Background: Data regarding the incidence, predictive factors, and clinical outcomes of post-transcatheter aortic valve replacement (TAVR) bleeding is limited in the Asian cohort. Objectives: This study sought to assess the predictors and prognostic impact of post-TAVR late bleeding. Methods: This study used the Japanese multicenter registry data to analyze 2,518 patients (mean age: 84.3 ± 5.2 years) who underwent TAVR. Late bleeding was defined as any postdischarge bleeding events after TAVR. Baseline characteristics, predictive factors, and clinical outcomes including death and rehospitalization were assessed in patients with and without late bleeding events. Results: The cumulative incidence rate of all and major late bleeding and ischemic stroke were 7.4%, 5.2%, and 3.4%, respectively, 3 years after TAVR. The independent predictive factors of late bleeding were low platelet count, high score (≥4) on the clinical frailty scale, and a New York Heart Association functional class III/IV. The cumulative mortality rates up to 3 years were significantly higher in patients with late bleeding than in those without bleeding (P < 0.001). The multivariate Cox regression analysis revealed that late bleeding, included as a time-varying covariate in the model, was associated with an increased risk of mortality following TAVR (HR: 5.63; 95% CI: 4.28-7.41; P < 0.001). Conclusions: Late bleeding after TAVR was not a rare complication, and it significantly increased long-term mortality. It should be carefully managed, especially when it is predictable in the high-risk cohort, and efforts should be taken to reduce bleeding complications even after a successful procedure.

The Usefulness of the Modified Essential Frailty Toolset to Predict Late Bleeding Events after Transcatheter Aortic Valve Implantation.

Frailty is strongly associated with poor short- and long-term prognoses in patients who undergo transcatheter aortic valve implantation (TAVI). However, limited data are available regarding the association between frailty and late bleeding events after TAVI. Of the 2,518 patients in the Japanese multicenter TAVI registry, 1371 patients with complete data on frailty parameters were analyzed. We developed a modified Essential Frailty Toolset (EFT) using 4 frailty parameters-gait speed, Mini-Mental State Examination (MMSE), anemia, and hypoalbuminemia-that are significant predictors of late bleeding events in this cohort. The predictive value of the modified EFT for late bleeding after TAVI was assessed in comparison with other clinical variables. Late bleeding events after TAVI occurred in 80 patients (5.8%). Gait speed, MMSE, anemia, and hypoalbuminemia were significantly associated with late bleeding. A modified EFT was developed to include these parameters, which were scored from 0 to 5 points comprising the following 4 items: gait speed (0: >1.5 m/s, 1: 1.5 to 0.75 m/s, 2: <0.75 m/s), cognition (1: MMSE <18), anemia (1: hemoglobin <13 g/100 ml in men or <12 g/100 ml in women), and malnutrition (1: albumin <3.5 g/100 ml). Multivariate Cox regression analysis revealed that the modified EFT was an independent predictor of late bleeding (adjusted hazard ratio 1.51, 95% confidence interval [CI] 1.19 to 1.92, p <0.001) In conclusion, the modified EFT was found to be a significant predictive factor for late bleeding events after TAVI. Assessment of frailty is important to predict patients with high bleeding risk after TAVI.

Impact of arm circumference on clinical outcomes in patients undergoing transcatheter aortic valve replacement.

Background: Although Arm circumference (AC) is considered to be a predictor of clinical outcomes of transcatheter aortic valve replacement (TAVR), limited data are available on the impact of this anthropometric measurement. This study aimed to investigate the clinical impact of AC on the outcomes of patients who underwent TAVR. Methods: AC was investigated in consecutive patients who underwent TAVR between March 2014 and May 2018. Patients were divided into low AC (n = 220) and high AC (n = 127) groups by a classification and regression tree (CART) survival model, and their baseline characteristics and mortality were compared. The correlations of AC with other frailty markers were also evaluated. Results: One-year clinical follow-up was completed in 100% of cases, and 89 patients (31 men, 58 women) died during the median follow-up period of 825 days. The low AC group was more fragile than the high AC group, and the AC value was significantly correlated with each frailty marker (all p < 0.05). The Cox regression analysis demonstrated the independent association of mortality with low AC (HR: 2.56, 95% confidence interval [CI]: 1.47-4.46, p < 0.001). When AC was compared to conventional prediction models of survival, the net reclassification improvement and the integrated discrimination improvement analysis showed significant improvements in predicting outcomes after including the AC with other frailty markers (all p < 0.05). Conclusions: The AC is related to frailty markers and is an important surrogate marker for predicting worse clinical outcomes after TAVR. Assessment of AC may be considered when deciding on 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.