Appropriate assessment using virtual reality simulation for a novel reshaped curve sheath during percutaneous left atrial appendage closure: a follow-up case report.

Background: We previously reported a case of successful percutaneous left atrial appendage closure (LAAC) for complex left atrial appendage (LAA) morphology using a handmade double-curve delivery sheath (DS) reshaped by a heat gun. However, whether the reshaped curve was appropriately adjusted as an optimal configuration for this patient's anatomy remained uncertain. Case summary: We established the LAAC procedural simulation model supported by virtual reality (VR) technology. With this VR simulator, the patient's whole heart model with venous access route and atrial septal puncture point of foramen ovale (FO) could be replicated based on the pre-procedural computed tomography image. Multiple views of the VR image provided a deep understanding of the patient-specific anatomy. Additionally, the operators were enabled to perform the virtual LAAC procedure using VR-derived LAAC devices, including various DS types. In the VR simulator, the manually reshaped DS showed better co-axiality from the FO to the LAA orifice than the conventional double-curve DS, resulting in the successful deployment inside the LAA of the VR simulator. However, the perpendicularity of the device towards the LAA orifice of the handmade reshaped DS remained insufficient. The VR simulator suggested that the ideal curve of the DS needed to change relatively posteriorly and have a more aggressive inferior slide than the previously reshaped DS. Discussion: The post-procedural review of the VR simulator confirmed that the sheath reshaping technique helped ensure successful LAAC. Pre-procedural VR simulation may be useful for procedural planning that includes DS reshaping for patients with challenging anatomy undergoing LAAC.

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.

Transcatheter aortic valve implantation and frailty.

Over the last decade, transcatheter aortic valve implantation (TAVI) has emerged as a treatment option for patients with severe aortic stenosis. With exponential increase in the number of TAVI procedures, frailty assessments have been considered important for patients undergoing TAVI, and a number of studies have indicated a relationship between the frailty and post-TAVI outcomes. In this review, using studies searched systematically in the PubMed database, we review important frailty assessment tools that can be used as prognostic factors for patients before TAVI. The assessment tools were categorized as quantitative single marker, semi-quantitative single marker, or quantitative combined marker. Studies were further stratified by whether they used frailty markers to predict patients' prognosis pre-TAVI or to evaluate frailty improvement post-TAVI. The Clinical Frailty Scale (CFS), a semi-quantitative assessment, is one of the frailty assessment tools discussed. It may be easily used even in an outpatient consultation room. The CFS classifies patients' activity into nine categories, based on a simple interview and the patient's appearance. Gait speed and serum albumin levels were considered as qualitative frailty assessment tools. Compared to other methods, the Essential Frailty Toolset had the highest inter-rater reliability for accuracy in predicting mortality, thereby allowing better identification of vulnerable old age people and optimization of outcomes. A few studies have also focused on changes in frailty pre- and post-TAVI. Serum albumin-level measurements are important for assessing the frailty improvement in the chronic phase. Each frailty assessment tool had its own characteristics, strengths, and weaknesses, and therefore, these tools need to be selected based on where they are being used and the patient's condition.

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.

Rescue Percutaneous Stenting for Cerebral Malperfusion With Acute Aortic Dissection Following TAVR.

Malperfusion syndrome is a complication of acute aortic dissection (AAD) involving a branch vessel. We report a case of bailout stenting for critical cerebral malperfusion in a patient with AAD after transcatheter aortic valve replacement. Rescue percutaneous procedure for this complication may be a treatment option in patients with high surgical risk. (Level of Difficulty: Advanced.).

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.

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.

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.

Incidence and Predictive Factors of Chronic Vessel Enlargement After Percutaneous Coronary Intervention for Severely Stenotic and Occluded Lesions.

BACKGROUND: Chronic vessel enlargement (CVE) of the coronary artery is observed in patients who undergo percutaneous coronary intervention (PCI) for severely stenotic or occluded lesions. Recently, the presence of a peri-medial high-echoic band (PHB) identified by intravascular ultrasound (IVUS) has been reported to correlate with this phenomenon. We sought to assess the incidence, predictive factors of CVE, and association between CVE and PHB. METHODS: From January 2017 to December 2018, 97 patients, with 101 severely stenotic and occluded lesions, who underwent IVUS-guided PCI and a 9-month follow-up angiography were enrolled. CVE was defined as more than a 10% increase of distal lumen gain at follow-up angiography. All lesions were stratified into 2 groups: CVE group and non-CVE group. Clinical outcomes were compared and predictive factors for CVE were assessed. Relationships between PHB angle and CVE were also assessed. RESULTS: At follow-up angiography, CVE was observed in 27 lesions (26.7%, 27/101). PHBs were frequently observed in the CVE group (88.9%), which was significantly higher than that in the non-CVE group (40.5%). The multivariate logistic regression analysis revealed that the presence of PHB was the only predictive factor for CVE (odds ratio, 11.3; 95% confidence interval, 2.95-43.0; p < 0.001). In addition, a linear relationship was observed between the incidence of CVE and PHB angle. The number of patients with CVE significantly increased in cases with a PHB angle more than 180 degrees. CONCLUSIONS: The presence of PHB strongly predicts CVE after PCI for severely stenotic or occluded lesions.

Current status of hybrid intravascular ultrasound and optical coherence tomography catheter for coronary imaging and percutaneous coronary intervention.

Both intravascular ultrasound (IVUS) and optical coherence tomography (OCT) play a crucial role in elucidating the pathophysiology of coronary artery disease (CAD) with the goal to improve patient outcomes of medical and/or interventional CAD management. However, no single intravascular imaging technique has been proven to provide complete and detailed evaluation of all CAD lesions due to some limitations. Although sequential use of multiple modalities may sometimes be performed, there may be issues related to risk, time, and cost. To overcome these problems, several hybrids involving dual-probe combined IVUS-OCT catheters have been developed. The aim of this review article is to demonstrate some limitations of stand-alone imaging devices for evaluation of CAD, summarize the advances in hybrid IVUS-OCT imaging devices, discuss the technical challenges, and present the potential value in the clinical setting, especially in patients receiving medical or interventional CAD management.

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.