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.

Impact of the Clinical Frailty Scale on Outcomes After Transcatheter Aortic Valve Replacement.

BACKGROUND: The semiquantitative Clinical Frailty Scale (CFS) is a simple tool to assess patients' frailty and has been shown to correlate with mortality in elderly patients even when evaluated by nongeriatricians. The aim of the current study was to determine the prognostic value of CFS in patients who underwent transcatheter aortic valve replacement. METHODS: We utilized the OCEAN (Optimized Catheter Valvular Intervention) Japanese multicenter registry to review data of 1215 patients who underwent transcatheter aortic valve replacement. Patients were categorized into 5 groups based on the CFS stages: CFS 1-3, CFS 4, CFS 5, CFS 6, and CFS ≥7. We subsequently evaluated the relationship between CFS grading and other indicators of frailty, including body mass index, serum albumin, gait speed, and mean hand grip. We also assessed differences in baseline characteristics, procedural outcomes, and early and midterm mortality among the 5 groups. RESULTS: Patient distribution into the 5 CFS groups was as follows: 38.0% (CFS 1-3), 32.9% (CFS4), 15.1% (CFS 5), 10.0% (CFS 6), and 4.0% (CFS ≥7). The CFS grade showed significant correlation with body mass index (Spearman's ρ=-0.077, P=0.007), albumin (ρ=-0.22, P<0.001), gait speed (ρ=-0.28, P<0.001), and grip strength (ρ=-0.26, P<0.001). Cumulative 1-year mortality increased with increasing CFS stage (7.2%, 8.6%. 15.7%, 16.9%, 44.1%, P<0.001). In a Cox regression multivariate analysis, the CFS (per 1 category increase) was an independent predictive factor of increased late cumulative mortality risk (hazard ratio, 1.28; 95% confidence interval, 1.10-1.49; P<0.001). CONCLUSIONS: In addition to reflecting the degree of frailty, the CFS was a useful marker for predicting late mortality in an elderly transcatheter aortic valve replacement cohort.

Importance of Geriatric Nutritional Risk Index assessment in patients undergoing transcatheter aortic valve replacement.

BACKGROUND: Nutritional condition is one marker of patients' frailty. The Geriatric Nutritional Risk Index (GNRI) is a well-known marker of nutritional status. This study sought to assess the clinical outcomes of GNRI after transcatheter aortic valve replacement (TAVR). METHODS: We evaluated the GNRI value of 1,613 patients who underwent TAVR using data from a Japanese multicenter registry. According to baseline GNRI, patients were classified into 3 groups: GNRI ≥92 (n = 1,085; 67.3%), GNRI 82-92 (n = 396; 24.6%), and GNRI ≤82 (n = 132; 8.2%). Baseline characteristics, procedural outcomes, and cumulative mortality rates were compared. In addition, GNRI correlations with other frailty components (gait speed, grip strength, and Clinical Frailty Scale) and Society of Thoracic Surgeons (STS) score were also evaluated. RESULTS: Significantly increased mortality rates were observed across the 3 groups at 30 days (0.9%, 2.3%, and 6.8%, respectively; P < .001) and 1 year (6.5%, 16.4%, and 36.4%, respectively; P < .001). Both GNRI 82-92 and GNRI ≤82 (as a reference for GNRI ≥92) were independently associated with increased midterm mortality in the Cox regression multivariate model (hazard ratio: 1.97, 3.60; 95% confidence interval: 1.37-2.84, 2.30-5.64; P < .001, P < .001, respectively). The GNRI value was significantly correlated with gait speed (Spearman ρ = -0.15, P < .001), grip strength (ρ = 0.25, P < .001), Clinical Frailty Scale (ρ = -0.24, P < .001), and STS score (ρ = -0.29, P < .001). CONCLUSIONS: GNRI is related to both frailty components and the STS score and is an important surrogate marker for predicting worse clinical outcomes after TAVR. Assessment of the GNRI may be considered when deciding on TAVR.

Impact of pre-procedural hyponatremia on clinical outcomes after transcatheter aortic valve replacement: A propensity-matched analysis.

BACKGROUND: Hyponatremia is associated with the increased risk of early and late mortality in patients with cardiac disease. This study aimed to assess the prognostic value of hyponatremia in patients who had undergone transcatheter aortic valve replacement (TAVR). METHODS: We investigated 1,215 consecutive patients (mean age: 84.4 ± 5.0 years) who underwent TAVR using data from the Optimized CathEter vAlvular iNtervention (OCEAN)-TAVR Japanese multicenter registry. Hyponatremia was defined as a serum sodium value less than 135 mEq/L. The baseline characteristics, procedural outcomes, all-cause, cardiovascular, and non-cardiovascular mortality were compared between patients with hyponatremia (n = 106, 8.7%) and without hyponatremia (n = 1,109, 91.3%). A propensity-matching analysis was used to adjust for the non-uniform patient characteristics. RESULTS: Differences in the baseline characteristics were observed between the two groups regarding the prevalence of pulmonary disease (37.7% vs. 28.9%, P = 0.04) and the performance of non-elective TAVR (10.4% vs. 4.2%, P = 0.01), although these were minimized in the matched model. The 30-day mortality rates differed between the two groups (7.6% vs. 1.4%, P < 0.001). During a mean follow-up of 330 days, the all-cause and cardiovascular mid-term mortality were higher in the hyponatremia group than in the non-hyponatremia group (log-rank test: P = 0.0047, and P < 0.001, respectively). The three findings above were not attenuated in the propensity-matched model (P < 0.001, P = 0.0044, and P = 0.014, respectively). In contrast, there was no difference in non-cardiovascular mortality between the two groups in both the overall and matched model (P = 0.40 and P = 0.13, respectively). CONCLUSIONS: Pre-procedural hyponatremia may be a useful marker for predicting early and mid-term clinical outcomes 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.

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.

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.

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.

Novel proctorship effectively teaches interventionists coronary artery chronic total occlusion lesions.

BACKGROUND: Interventionists' experience and skills are essential factors for successful chronic total occlusion-percutaneous coronary intervention (CTO-PCI). However, the construction of theoretical strategy independent from interventionists' procedure may also improve it. We sought to assess the feasibility of CTO-PCI using an educational system supported by a single expert proctor. METHODS: A total of 160 patients underwent CTO-PCI between 2009 and 2016 at 92 Japanese centers in the Hands-on proctorship project. The CTO-PCI strategy was discussed with all participants and their specialists, before and during the procedure. We divided patients into 2 groups based on the CTO-PCI experience of their interventionist: (1) the less experienced group (CTO-PCI ≤50 cases, n=65) and (2) the more experienced group (CTO-PCI >50 cases, n=95). Baseline characteristics, procedural complications, and clinical outcomes were compared between groups. RESULTS: No significant differences in patient age, sex, prevalence for coronary risk factors, and lesion complexity was observed between groups. The retrograde approach was used equivalently between groups (55.4% vs. 60.0%, p=0.56), and procedural success rates were similar (96.9% vs. 90.5%, p=0.12). The rate of proctor's bailout for recanalization were not frequent between groups (4.6% vs. 5.3%, p=0.85). No procedure-related mortality was noted in either group. In addition, no significant differences in procedural cardiac complications, including coronary dissection, perforation, or tamponade, were observed between groups (10.8% vs. 14.7%, p=0.47). CONCLUSIONS: The expert-supported CTO-PCI maintained high success rates regardless of interventionists' experience. This highlights the importance of theoretical strategy for the management patients undergoing CTO-PCI.

Patients Refusing Transcatheter Aortic Valve Replacement Even Once Have Poorer Clinical Outcomes.

Background Although transcatheter aortic valve replacement ( TAVR ) is the least invasive treatment for patients with symptomatic aortic stenosis, some patients hesitate to undergo the procedure. We investigated the clinical impact of treatment delay after patient refusal of TAVR . Methods and Results We used the Japanese OCEAN (Optimized Catheter valvular intervention) regsitry data of 1542 patients who underwent TAVR . Refusal was defined as at least 1 refusal of TAVR at the time of informed consent. Patients were separated into 2 groups: refusal (28/1542, 1.8%) and non-refusal (1514/1542, 98.2%). We compared the baseline characteristics, procedural outcomes, and mortality rates between the groups. Additionally, data on reasons for refusal and those leading to eventually undergoing TAVR were collected. Age, surgical risk scores, and frailty were higher in the refusal group than in the non-refusal group ( P<0.05 for all). Periprocedural complications did not differ between groups, whereas 30-day and cumulative 1-year mortality were significantly higher in the refusal group than in the non-refusal group (7.1% versus 1.3%, P=0.008 and 28.8% versus 10.3%, P=0.010, respectively). Multivariate Cox regression analysis revealed that TAVR refusal was an independent predictor of increased midterm mortality (hazard ratio: 3.37; 95% confidence interval: 1.52-7.48; P=0.003). The most common reason for refusal was fear (13/28, 46.4%), and the most common reason for changing their mind was worsening heart failure (21/28, 75.0%). All patients in the refusal group decided to undergo TAVR within 20 months (median: 5.5 months). Conclusions Refusing TAVR even once led to poorer prognosis; therefore, this fact should be clearly discussed when obtaining informed consent.

The incidence, predictive factors and prognosis of acute pulmonary complications after transcatheter aortic valve implantation.

OBJECTIVES: Although acute pulmonary complications (APCs), such as the exacerbation of pulmonary disease (PD) or a newly developed pulmonary event, are thought to be catastrophic after invasive therapy, little is known about the occurrence of APCs after transcatheter aortic valve implantation (TAVI). This study aims to clarify the incidence, predictive factors and impact of APCs on prognosis after TAVI. METHODS: We identified 749 patients who underwent TAVI, using data from the Optimized CathEter vAlvular iNtervention (OCEAN-TAVI) Japanese multicentre registry. APCs were defined as exacerbation of a comorbidity or newly developed PD during hospitalization. Patients were divided into 2 groups: an APC group (1.5%, 11/749) and a non-APC group (98.5%, 738/749). Clinical and prognostic outcomes were compared, and predictive factors for APCs were assessed. RESULTS: Procedure-related death did not differ between the groups (0.4% vs 0.0%, P = 1.00), although 30-day mortality was significantly higher in the APC group than in the non-APC group (27.3% vs 1.6%, P = 0.001) and the difference in cumulative 1-year mortality increased further (72.7% vs 8.6%, log-rank test: P < 0.001). In particular, concomitant PD and transapical (TA) approach were identified as predictors of APCs after TAVI [univariable odds ratio (uOR) = 24.2, 95% confidence interval (CI) = 3.08-189.9, P = 0.002; uOR = 3.69, 95% CI = 1.11-12.3, P = 0.033, respectively]. CONCLUSIONS: Although rare, the occurrence of APCs after TAVI was associated with extremely poor prognosis. Patients undergoing TAVI with concomitant PD and/or TA require careful consideration to avoid the risk of APCs.

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.

Gait Speed Can Predict Advanced Clinical Outcomes in Patients Who Undergo Transcatheter Aortic Valve Replacement: Insights From a Japanese Multicenter Registry.

BACKGROUND: Gait speed reflects an important factor of frailty and is associated with an increased risk of late mortality in patients with cardiac disease. This study sought to assess the prognostic value of gait speed in elderly patients who underwent transcatheter aortic valve replacement. METHODS AND RESULTS: We investigated the 5-m or 15-feet gait speed (m/sec) in 1256 patients who underwent transcatheter aortic valve implantation using data from the OCEAN-TAVI Japanese multicenter registry (Optimized Catheter Valvular Intervention-Transcatheter Aortic Valve Implantation). Baseline characteristics, procedural outcomes, and all-cause mortality were compared among groups defined by differential gait speed classification: model 1, normal (>0.83 m/sec; n=563; 44.8%), slow (0.5-0.83 m/sec; n=429; 34.2%), slowest (<0.83 m/sec; n=205; 16.3%), unable to walk (n=48; 3.8%); and model 2, classification and regression tree survival model indicating the threshold of gait speed as 0.385 m/sec (>0.385 m/sec; n=1080 versus ≤0.385 m/sec; n=117). The cumulative 1-year mortality rate showed significant differences in the classical gait speed groups in model 1 (7.6%, 6.6%, 18.2%, and 40.7%, respectively; P<0.001) and survival classification and regression tree group in model 2 (7.7% versus 21.9%; P<0.001). The slowest walkers and those unable to walk demonstrated independent associations with increased midterm mortality after adjustment for several confounding factors (hazard ratio, 1.83, 4.28; 95% confidence interval, 1.03-3.26, 2.22-8.72; P=0.039, <0.001, respectively). Gait speed <0.385 m/sec determined by classification and regression tree also independently associated with worse prognosis (hazard ratio, 2.40; 95% confidence interval, 1.75-5.88; P=0.001). CONCLUSIONS: Gait speed using both traditional and specific classification is useful as a potential marker for predicting vulnerable patients associated with adverse clinical outcomes after transcatheter aortic valve replacement.

Impact of frailty markers on outcomes after transcatheter aortic valve replacement: insights from a Japanese multicenter registry.

There are no standardized criteria for measuring patients' frailty. We examined prognosis based on four frailty markers [serum albumin level, grip strength, gait speed, and clinical frailty scale (CFS)] in patients who underwent transcatheter aortic valve replacement (TAVR) between October 2013 and April 2016 and were recorded in the Optimized CathEter vAlvular iNtervention (OCEAN) Japanese multicenter registry. Serum albumin level was assessed by dividing patients into two groups: hypoalbuminemia or non-hypoalbuminemia according to their serum albumin level. Clinical outcomes including all-cause, cardiovascular and non-cardiovascular mortality rates after TAVR were compared. During the follow-up period cumulative all-cause, cardiovascular and non-cardiovascular mortality rates were significantly higher in the hypoalbuminemia group than in the non-hypoalbuminemia group. This result remained unchanged even after a propensity-matched model was used in terms of cumulative all-cause and non-cardiovascular mortality; however, differences in cardiovascular mortality rates were attenuated. To consider the impact of grip strength patients were divided into a low or high peak grip strength group based on classification and regression tree (CART) survival analysis. The clinical outcomes for each sex were compared between the two groups. In both sexes the cumulative 1-year mortality rates were significantly different between the two groups. To investigate gait speed patients were classified into two gait speed groups (low or high gait speed group) based on CART survival analysis. Clinical outcomes were compared between the two groups. The cumulative 1-year mortality rate was significantly different between the two gait speed groups. The effect of CFS on prognosis after TAVR was assessed. Patients were categorized into five groups based on the following CFS scores: CFS1-3, CFS4, CFS5, CFS6, and CFS ≥7. We evaluated the relationship between the CFS score and other indicators of frailty markers. We also assessed the mid-term mortality among the five groups. The CFS score had a significant correlation with other frailty markers. The cumulative 1-year mortality increased with an increasing CFS score. In the Cox regression multivariable analysis, the CFS score was an independent predictive factor of an increased late cumulative mortality risk. In conclusion, the results suggest that serum albumin level, grip strength, gait speed, and CFS score are all useful indicators when considering the optimal indications and risk stratification for TAVR.

Impact of preparatory coronary protection in patients at high anatomical risk of acute coronary obstruction during transcatheter aortic valve implantation.

BACKGROUND: This study aimed to assess the effectiveness of preparatory coronary protection (CP) in patients considered at high risk of acute coronary obstruction (ACO) after transcatheter aortic valve implantation (TAVI). METHODS: The Optimized CathEter vAlvular iNtervention (OCEAN-TAVI) Japanese multicenter registry enrolled 666 consecutive patients. All patients were assessed by preprocedural multidetector computed tomography. CP using a guide wire with or without a balloon was prospectively performed according to the following criteria: 1) coronary height length from the annulus <10mm, 2) evidence of ACO during balloon aortic valvuloplasty with simultaneous aortic injection, and 3) shallow valsalva or bulky calcification on the leaflet. The incidence of ACO and other procedural outcomes were compared between the CP and non-CP groups. RESULTS: CP was performed in 14.1% of all patients (94/666). ACO had an incidence of 1.5% (10/666) and mainly occurred in women (70%) and the left coronary artery (70%). The ACO rate was significantly higher in the CP group than in the non-CP group (7.4% [7/94] vs. 0.5% [3/572]; p<0.001), although notably 30% of ACO were occurred in non-CP group. All 10 ACO cases were successfully treated by catheter intervention, although periprocedural myocardial injury occurred in 42.9% of patients with CP group and 33.3% of those without CP group. Mortality and other periprocedural complications did not significantly differ between the 2 groups. CONCLUSION: The preparatory CP strategy was feasible for the management of ACO during TAVI, but the complication of ACO was difficult to predict completely.

Extreme late-phase observation using coronary angioscopy until 7 years after sirolimus-eluting stent implantation.

BACKGROUND: Little is known about the very late-phase morphological vessel characteristics within the sirolimus-eluting stent (SES). METHODS AND RESULTS: We assessed a total of 12 patients with 15 SES implantations who underwent repeat angiographic and angioscopic procedures after 5 and 7 years. The degree of neointimal stent coverage (NSC) was classified as follows: grade 0, uncovered struts; grade 1, visible struts through a thin neointima; or grade 2, invisible struts with complete neointimal coverage. The maximum and minimum NSC grades were evaluated and the existence of in-stent thrombus was also recorded for all patients. The prevalence of a maximum NSC grade of 2 increased and that of a minimum NSC grade of 0 decreased, although there was no significant difference in prevalence between 5 and 7 years. One of four in-stent thrombus identified at 5 years had disappeared from 5 to 7 years and a new thrombus was found in another patient at 7 years. Thus, the incidence of in-stent thrombus did not change from 5 to 7 years. In one case, a thrombus was observed inside the angiographic aneurysmal change, but none of the thrombi were related to adverse events. CONCLUSION: This angioscopic study reported gradual arterial repair and continuous delayed healing associated with subclinical thrombus formation 7 years after SES deployment.

Rates of future hemodialysis risk and beneficial outcomes for patients with chronic kidney disease undergoing recanalization of chronic total occlusion.

BACKGROUND: This study aimed to assess the prognosis and deleterious effects of chronic kidney disease (CKD) on future renal function, in patients who had undergone chronic total occlusion-percutaneous coronary intervention (CTO-PCI). METHODS: The treatment effects were studied in 739 patients who underwent CTO-PCI. The patients were divided into 3 groups according to estimated glomerular filtration rate (eGFR): non-CKD (eGFR≥60ml/min/1.73m(2), n=562), CKD-1 (45≤eGFR<60ml/min/1.73m(2), n=90), and CKD-2 (eGFR<45ml/min/1.73m(2), n=87). Future hemodialysis (HD) rates and the prevalence of acute kidney injury (AKI) except for 45 patients undergoing regular HD, and other clinical and prognostic outcomes were compared between the 3 groups. RESULTS: Procedural success rates showed trends toward lower prevalence across the 3 groups (89.5%, 84.4%, and 81.6%, p=0.060). The prevalence of AKI significantly differed between the 3 groups (4.6%, 8.9%, and 16.7%, p=0.001), whereas no patients were introduced to regular HD at discharge. During a median follow-up period of 51.2±28.9months, newly required HD significantly differed between the 3 groups (0.7%, 0%, and 7.1%, p<0.001). When compared with unsuccessful CTO-PCI, successful CTO-PCI was found to improve cardiovascular mortality in the non-CKD and CKD-1 (Log-rank test: p=0.025, p=0.024, respectively) and to improve both cardiovascular and all-cause mortality in the CKD-2 (Log-rank test: p=0.027, p=0.0022, respectively). CONCLUSIONS: Although CTO-PCI for patients with advanced CKD was associated with a high risk of future HD introduction, not directly owing to CTO-PCI and AKI, successful treatment of CTO might contribute to better survival benefit regardless of the presence or absence of CKD.

Safety of Live Case Demonstrations in Patients Undergoing Percutaneous Coronary Intervention for Chronic Total Occlusion.

The data regarding the risk and benefits associated with live demonstrations at interventional cardiology congresses are scarce and controversial. We aimed to assess the clinical safety of chronic total occlusion percutaneous coronary intervention (CTO-PCI) procedures during live demonstrations. From January 2008 to December 2013, 739 consecutive patients underwent CTO-PCI at our center, and 199 patients were scheduled to undergo live CTO-PCI demonstrations at cardiology congresses that were globally transmitted to international meetings. The baseline characteristics, procedural complications, and clinical outcomes were compared between the live demonstration group and nonlive demonstration group. The procedural success rates were similar in the live demonstration group than in the nonlive demonstration group (91.5% vs 86.7%, p = 0.076), although the CTO lesions were longer and more tortuous in the live demonstration group (p = 0.029, p = 0.022, respectively). No cases of 30-day mortality were noted in the live demonstration group (0% vs 0.7%, p = 0.28), and no significant differences in procedural complications, such as coronary dissection, coronary perforation, and cardiac tamponade, were observed between the groups (p = 0.53, p = 0.12, and p = 0.40, respectively). The survival rates were similar in the 2 groups at a median follow-up duration of 51.2 ± 28.9 months (log-rank test: p = 0.45). Compared with cases of unsuccessful CTO-PCI, the cases of successful CTO-PCI exhibited improved all-cause survival in both the live and nonlive demonstration groups (log-rank test: p = 0.045, p = 0.0056, respectively). In conclusion, we found that procedural and clinical outcomes of live demonstration CTO-PCI were not significantly different compared with cases undergoing routine CTO-PCI procedures.

Usefulness of routine aortic valve calcium score measurement for risk stratification of aortic stenosis and coronary artery disease in patients scheduled cardiac multislice computed tomography.

OBJECTIVES: This study sought to investigate the clinical utility of aortic valve calcium score (AVCS) determined by using cardiac multislice computed tomography (MSCT). METHODS: Data of 1315 consecutive patients who underwent both conventional echocardiography and MSCT were reviewed. Degree of aortic stenosis (AS) was assessed according to mean pressure gradient (mPG) measured by echocardiography. Extent of coronary artery disease (CAD) derived by MSCT also was evaluated in 1173 patients who did not undergo prior coronary treatment. Both AVCS and coronary calcium score (CCS) were defined by Agatston units (AU) according to MSCT findings. RESULTS: A total of 613 of 1315 patients were defined as AVCS positive (mean, 100 AU [range, 31.0-380.0 AU]). AVCS showed significant correlations with mPG (Spearman's ρ = 0.81, p < 0.001), and CCS (ρ = 0.53, p < 0.001). Differential adequate cut-off values of AVCS were proved for predicting severe AS with mPG ≥ 40 mmHg (1596.5 AU; AUC, 0.88; sensitivity, 89.7%; specificity, 77.0%), and for predicting moderate AS with mPG ≥ 20 mmHg (886.5 AU; area under the curve [AUC], 0.91; sensitivity, 92.4%; specificity, 78.3%). Mean AVCS was higher with increased extent of CAD (none, 0 AU [range, 0-30 AU]; single vessel, 8.5 AU [range, 0-104 AU]; multivessel, 142 AU [range, 10-525 AU]; p < 0.001). The optimal cut-off value of AVCS for predicting multivessel disease was 49 AU (AUC, 0.77; sensitivity, 68.8%; specificity, 78.0%). CONCLUSIONS: AVCS might be a surrogate marker not only for AS grading but also for CAD progression. Therefore, routine AVCS assessment could be useful for risk stratification.