Validation of Global Limb Anatomical Staging System (GLASS) in patients with hemodialysis and Chronic Limb-Threatening Ischemia after endovascular treatment.

Recently, Society for Vascular Surgery guideline recommends evaluating anatomic pattern with use of Global Limb Anatomic Staging System (GLASS) in Chronic Limb-Threatening Ischemia (CLTI) patients. The aim of this study is to validate GLASS stage into CLTI patients on hemodialysis (HD) and investigate the impact of GLASS stage to wound healing and amputation-free survival (AFS). Between April 2009 and March 2018, we performed EVT for 154 limbs in CLTI patients on HD. GLASS was defined as femoropopliteal (FP) and infrapopliteal (IP) segments separately graded (0-4), then combined into three GLASS stages for the limb (I-III). We divided them into three GLASS stages with using this system. We compared the clinical outcomes between three groups (GLASS I, GLASS II, and GLASS III). Patient characteristics were almost similar between the three groups. Lesion characteristics was more complex and the rate of success was lower in GLASS III. Cox regression multivariate analysis revealed that diabetes mellitus (HR 2.4, 95% CI 1.37-4.01, p < 0.01) and WIfI high (HR 2.3, 95% CI 1.04-6.01, p = 0.04) were the predictors of non-wound healing, whereas age (HR 1.6, 95% CI 1.09-2.29, p = 0.01), WIfI clinical stage 4 (HR 2.4, 95% CI 1.30-4.36, p < 0.01), and non-ambulatory status (HR 2.0, 95% CI 1.17-3.29, p = 0.01) were the predictors of AFS. GLASS stage in CLTI patient on HD could not predict wound healing, and AFS in this study.

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.

An External Iliac Artery Pseudoaneurysm Resulting From Stent Graft Migration.

The case of an 80-year-old male with claudication of his left foot who was referred to our hospital for evaluation and treatment. Computed tomography (CT) angiography revealed occlusion of left common and external iliac (EIA) arteries. Recanalization of the EIA lesion under intravascular ultrasound (IVUS) guidance and placement of 2 stent grafts was completed successfully. Nine months later, 27 × 29 mm pseudoaneurysm of the left EIA was identified that appeared to have developed secondary to migration of the original stent graft. A new stent graft was placed.

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.

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.

Early and long-term results of surgery for secondary mitral regurgitation with a damaged heart.

BACKGROUND: Surgery for secondary mitral regurgitation is still controversial, especially when the left ventricle is damaged. The Mitra Clip has been shown to be safe and effective for certain patient groups but does not offer superior control of mitral regurgitation compared with the surgery. If performed safely, the surgery can provide greater benefits over the long-term. The objective of this study was to retrospectively investigate the early and long-term results of mitral valve surgery for secondary mitral valve regurgitation with a damaged, dilated left ventricle. METHODS: Patients with ejection fraction <40% and left ventricular end-diastolic/systolic diameter >50/40 mm who underwent mitral valve surgery for secondary mitral regurgitation were investigated retrospectively. RESULTS: The mean age of the 80 identified cases was 65.7 years, and 63 patients were male. Preoperative echocardiograms showed a mean ejection fraction of 25.2% and mean left ventricular diameters in diastole/systole of 64.5/56.9 mm, respectively. Mitral valve replacement was performed in 39 cases, and mitral valve plasty in 41 cases. The most common concomitant procedures were coronary artery bypass grafting and tricuspid valve surgery (41.3% each). Mitral regurgitation improved significantly from 3.5 to 0.83, and no operative or in-hospital deaths were encountered. Long-term results showed actual 1-, 3- and 5-year survival rates of 93.1%, 80.0%, and 64.7%, respectively (mean follow-up, 1264 days). CONCLUSIONS: Early results of this study were good and long-term results were acceptable. Our results suggest that mitral valve surgery is feasible for secondary mitral valve regurgitation even in dilated, damaged hearts.

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.

Safety and efficacy of minimalist approach in transfemoral transcatheter aortic valve replacement: insights from the Optimized transCathEter vAlvular interventioN-Transcatheter Aortic Valve Implantation (OCEAN-TAVI) registry.

OBJECTIVES: Favourable results have been reported for monitored anaesthesia care that includes local anaesthesia and conscious sedation [minimalist approach (MA)] for transfemoral transcatheter aortic valve replacement (TAVR). However, the efficacy of MA is still controversial in Japan. We describe our experience from a Japanese multicentre registry. METHODS: Between October 2013 and April 2016, 1215 consecutive Japanese patients with symptomatic, severe aortic stenosis undergoing TAVR with self-expandable or balloon-expandable valves were prospectively included in the Optimized transCathEter vAlvular intervention-Transcatheter Aortic Valve Implantation (OCEAN-TAVI) registry. Of these patients, we retrospectively reviewed 921 consecutive patients who underwent elective transfemoral-TAVR. We evaluated the perioperative results of MA-TAVR and non-minimalist approach (NMA) TAVR using propensity score matching analysis. RESULTS: A total of 118 patients underwent MA-TAVR, and 802 patients underwent NMA-TAVR [median age 84 vs 85 years, P = 0.25; Society of Thoracic Surgeons (STS) score 7.6 vs 6.4, P = 0.01]. One hundred eighteen matched pairs were compared after propensity score matching. In-hospital mortality and stroke/transient ischaemic attack were not significantly different between the MA-TAVR and the NMA-TAVR groups (2.5% vs 0.8%, P = 0.3; 1.7% vs 0.8%, P = 0.6, respectively). Major or life-threatening bleeding and the transfusion rate were significantly lower in the MA-TAVR group (3.4% vs 17%, P = 0.003; 6.8% vs 29%, P = 0.0002, respectively). The total intensive care unit days and length of hospital stay were significantly lower in the MA-TAVR group (P ≤ 0.0002). CONCLUSIONS: MA-TAVR has similar results to NMA-TAVR in terms of mortality and stroke in this Japanese multicentre registry. Shorter procedure time and hospital stays were seen in the MA-TAVR group. MA-TAVR is as safe and effective as NMA-TAVR.

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.

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.

Store-operated Ca2+ entry suppresses distention-induced ATP release from the urothelium.

Epithelial cells in the urinary bladder (urothelium) trigger sensory signals in micturition by releasing ATP in response to distention of the bladder wall. Our previous study revealed the distinct roles of extracellular Ca(2+) and the Ca(2+) stores in the endoplasmic reticulum (ER) in urothelial ATP release. In the present study, we investigated the regulation of urothelial ATP release by Ca(2+) influx from the extracellular space and Ca(2+) release from the ER using a distention assay of the mouse bladder wall in a small Ussing chamber. Stimulation of Ca(2+) release from the ER in the mucosal side of the bladder induced significant ATP release without distention. Blockade of the inositol 1,4,5-triphosphate receptor reduced distention-induced ATP release, suggesting that Ca(2+) release from the ER is essential for the induction of urothelial ATP release. On the other hand, blockade of store-operated Ca(2+) entry (SOCE) from the extracellular space significantly enhanced distention-induced ATP release. Thus Ca(2+) release from the ER causes urothelial ATP release and depletion of Ca(2+) stores in the ER, which in turn causes the depletion-inducing SOCE to suppress the amount of urothelial ATP released.

Extracellular Ca2+ regulates the stimulus-elicited ATP release from urothelium.

Accumulating evidence shows that the epithelial cells in urinary bladder (urothelium) serve as a sensory organ in micturition and/or in nociception pathway by releasing ATP in response to mechanical and/or chemical stimuli. Here, we compared the effects of capsaicin, acetylcholine, and prostaglandin E(2) receptor EP1 agonist (ONO-DI-004) on the urothelial ATP release in primary cultured mouse urothelial cells in low Ca(2+) medium. All of these chemicals induced a gradual ATP release from urothelium, implying that the downstream Ca(2+) release from endoplasmic reticulum could trigger the ATP release. Consistent with this suggestion, blockade of inositol 1,4,5-triphosphate receptor reduced the distention-induced ATP release from urothelial tissues. The distention-induced ATP release was not affected by tetrodotoxin. However, an increase in extracellular Ca(2+) diminished both chemical- and distention-induced ATP release from urothelium. Thus raising the extracellular Ca(2+) concentration was found to inhibit stimulation-evoked ATP urothelial release.