Abstract Hypoalbuminemia, a frailty criterion, belongs to a group of comorbidities not captured as a traditional risk factor. We assessed its prognostic value in patients who underwent transcatheter ...aortic valve implantation (TAVI). The study included 1215 consecutive patients from the Optimized CathEter vAlvular iNtervention (OCEAN)-TAVI Japanese multicenter registry. Hypoalbuminemia was defined as serum albumin level<3.5 g/dL. Baseline characteristics, procedural outcomes, and all-cause, cardiovascular, and non-cardiovascular mortality rates after TAVI were compared between patients with albumin level<3.5 g/dL (hypoh-ALB group, n=284) and those with albumin level>3.5 g/dL (nonhyponh-ALB group, n=931). Several baseline characteristics differed significantly between both groups, including age (85.1±5.1 years 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 non-cardiovascular 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 analysed 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 non-cardiovascular mortality was retained (p=0.038, and p=0.0068, respectively); however, differences in cardiovascular mortality rates in the two groups were attenuated (p=0.93). In conclusion, hypoalbuminemia was associated with poor prognosis, highlighted by the increase in non-cardiovascular mortality. Baseline albumin level could be a useful marker for risk stratification before TAVI.
The aim of this study was to evaluate postprocedural and midterm outcomes of transcatheter aortic valve implantation (TAVI) in patients with aortic stenosis and active cancer. From October 2013 to ...August 2015, a total of 749 patients undergoing TAVI using the Edwards Sapien XT prosthesis (Edwards Lifesciences, Irvine, California) were prospectively included in the OCEAN-TAVI registry from 8 Japanese centers. A total of 47 patients (44.7% men; median age 83 years) had active cancer. The transfemoral approach was implemented in 85.1% of patients in the cancer group and 78.1% in the noncancer group (p = 0.22). The occurrence of major vascular complication (4.3% vs 7.5%, p = 0.24), life-threatening bleeding (2.1% vs 7.1%, p = 0.15), and major bleeding (8.5% vs 13%, p = 0.38) was similar between the cancer and noncancer groups. No significant differences were observed regarding device success (100% vs 96.2%, p = 0.17) or 30-day survival (95.7% vs 97.3%, p = 0.38). No difference in midterm survival was found between the patients with cancer and without cancer (log-rank, p = 0.42), regardless of advanced or limited cancer (log-rank, p = 0.68). In a multivariable Cox proportional hazard regression analysis, cancer metastasis was one of the most significant predictors of late mortality (hazard ratio 4.73, 95% CI 1.12 to 20.0; p = 0.035). In conclusion, patients with cancer with severe aortic stenosis who underwent TAVI had similar acute outcomes and midterm survival rates compared with patients without cancer. Cancer metastasis was associated with increased mortality after TAVI.
Abstract Objectives The aim of this study was to determine the impact of pre-existing right bundle branch block (RBBB) on clinical outcomes after transcatheter aortic valve replacement (TAVR). ...Background The impact of pre-existing RBBB on clinical outcomes after TAVR is unknown. Methods Between October 2013 and August 2015, 749 patients undergoing TAVR using the Edwards SAPIEN XT prosthesis were prospectively enrolled in the OCEAN-TAVI (Optimized Transcatheter Valvular Intervention) registry from 8 Japanese centers. Electrocardiograms were obtained at baseline. After the procedure, follow-up outpatient visits or telephone interviews were conducted at 30 days, 6 months, and yearly. Results A total of 102 patients (13.6%) had pre-existing RBBB. The incidence of new pacemaker implantation was significantly higher in the RBBB group (17.6% vs. 2.9%; p < 0.01). The Kaplan-Meier analysis revealed that cardiovascular survival probability was significantly lower in the RBBB group than the no-RBBB group (log-rank p < 0.01). Patients with RBBB and without pacemakers were at higher risk for cardiovascular mortality in the early phase after discharge, and patients with RBBB and pacemakers had higher cardiovascular mortality at mid-term follow-up (log-rank p = 0.01). A multivariate Cox regression model indicated that pre-existing RBBB (hazard ratio: 2.59; 95% confidence interval: 1.15 to 5.85; p < 0.01) was an independent predictor of cardiovascular mortality. Conclusions Patients with RBBB demonstrated an increased risk for cardiovascular mortality after TAVR, and patients with RBBB and without pacemakers were at higher risk for cardiac death early after discharge. Patients with prior RBBB should be carefully monitored after undergoing TAVR.
Abstract The aim of this study was to evaluate the incidence, predictors, and outcomes of percutaneous closure device (PCD) failure during transfemoral transcatheter aortic valve implantation (TAVI) ...with an Edwards Sapien-XT prosthesis (Edwards Lifesciences, Irvine, California, USA) using an expandable sheath (eSheath). Between October 2013 and April 2016, 1215 patients who underwent TAVI were prospectively enrolled in the optimized transcatheter valvular intervention (OCEAN-TAVI) registry. Of these, 478 patients underwent transfemoral TAVI with Sapien-XT prosthesis using an eSheath and percutaneous closure with a Perclose ProGlide system (Abbott Laboratories, Abbott Park, Illinois, USA). We evaluated the predictors of PCD failure and whether it affected the clinical outcomes. Patients were aged 85 years (interquartile range: 82–88 years). PCD failure occurred in 36 patients (8%). Sheath to femoral artery ratio (SFAR) (per 1 increase) (odds ratio: 5.40, 95% confidence interval: 1.28–22.92, p = 0.022) predicted PCD failure in a multivariate model. The sensitivity-specificity curves identified an SFAR threshold of 1.03; the area under the curve for SFAR as a predictor of PCD failure was 0.629. The PCD failure group did not have a higher rate of 30-day mortality (0% vs. 1%, p = 0.52) or mid-term (365-day) mortality (log-rank test p = 0.85) compared to the PCD success group in the Kaplan-Meier analysis. In conclusion, PCD failures occurred in 8% of the patients and were not associated with 30-day or mid-term mortality rates after percutaneous transfemoral TAVI. The SFAR threshold of 1.03 was useful for predicting PCD failures.
Abstract Objectives The aims of this study were to assess whether the transradial approach can be applied to treat complex chronic total occlusion (CTO) and to determine the predictors of transradial ...percutaneous coronary intervention (PCI) failure. Background Consistent data on the outcomes of transradial PCI for treating CTO are scarce. Methods Consecutive patients who were not receiving hemodialysis and had undergone PCI for CTO were enrolled. The clinical and angiographic characteristics, procedural details, and outcomes of the transradial and transfemoral procedures were examined. Results In total, 280 and 305 CTO PCI procedures involved transradial and transfemoral access, respectively. The technical success rates did not significantly differ in the entire cohort analysis and the propensity score–matched analysis (74.6% vs. 72.5%; p = 0.51 and 70.6% vs. 73.3%; p = 0.57). When only cases with J-CTO (Multicenter Chronic Total Occlusion Registry of Japan) scores of ≥3 were examined, the transradial group had a significantly lower success rate than the transfemoral group (35.7% vs. 58.2%; p = 0.04). The use of guiding catheter size <7 F (odds ratio OR: 5.50; p = 0.008), calcification (OR: 3.20; p = 0.001), occlusion length >20 mm (OR: 2.97; p < 0.001), and age (OR: 1.04; p = 0.03) were associated with transradial CTO PCI failure. Conclusions Transradial PCI for CTO may be feasible in noncomplex cases, although complex cases still pose a challenge. In cases of transradial PCI for CTO, if possible, guiding catheter size ≥7 F should be selected regardless of lesion morphology. Furthermore, the transfemoral approach should be preferentially considered for complex CTO, particularly in cases with calcification.
In atherosclerosis, carotid artery stenosis (CAS), renal artery stenosis (RAS), lower extremity peripheral arterial disease (PAD), and coronary artery disease (CAD) are common pathologic lesions; ...their interrelationship is, however, unclear. We studied concomitant multiple atherosclerotic lesions in patients with CAD to understand their prevalence and relations. A cross-sectional analysis was performed on data from consecutive patients who underwent nonemergent coronary angiography. Simultaneous carotid and renal artery Doppler studies and ankle-brachial systolic pressure measurements were reviewed to diagnose concomitant lesions and their severity. The study included 1,734 patients (aged 71 ± 9 years; 70% men), with prevalences of CAS, RAS, lower extremity PAD, and CAD of 6%, 7%, 13%, and 72%, respectively. In patients with CAD (n = 1,253), the prevalences of CAS, RAS, and lower extremity PAD were 7%, 9%, and 16%, respectively; 24% CAD patients had ≥1 additional atherosclerotic lesion. Significant interactions among the prevalences of these lesions were found. In addition, the extent of CAD and the prevalences of CAS, RAS, and lower extremity PAD were significantly correlated. Multivariate analysis supported these relationships. In conclusion, the prevalences of CAS, RAS, lower extremity PAD, and CAD were strongly interrelated in the study population; CAD severity was related to that of other atherosclerotic lesions. Additional systematic screening of other concomitant atherosclerotic lesions is recommended, especially in CAD patients having multivessel disease, left main disease, and/or already diagnosed with other concomitant atherosclerotic lesions.
Few reports are available on the safety and efficacy of percutaneous coronary intervention (PCI) for chronic total occlusions (CTOs) in older patients. In the present study, 284 patients who ...underwent PCI for CTOs were retrospectively evaluated by comparing the characteristics of 67 patients aged ≥75 years (the older group) and 217 patients aged <75 years (the younger group). Technical success was achieved in 77% of the patients in the older group and 79% of those in the younger group (p = 0.66). No significant differences were observed between the 2 groups in terms of the incidence of procedural complications. In the older group, a comparison between the patients with successful and failed PCI revealed significantly superior 3-year cardiac survival (97.6% vs 76.9%, p = 0.005). The 3-year cardiac survival of those with successful PCI was similar to that observed in the younger group. On multivariate analysis, successful PCI was found to be associated with a lower incidence of cardiac death in the older group (hazard ratio 0.09, 95% confidence interval 0.01 to 0.91, p = 0.042). In conclusion, this single-center, observational study suggests that PCI for CTOs can be performed with a high rate of procedural success and acceptably low mortality and morbidity in older patients, resulting in improved cardiac survival. Thus, PCI for CTO lesions should be included among the treatment strategies for older patients.
Abstract Objectives This study aimed to analyze the prognostic impact of low-flow (LF) severe aortic stenosis in small-body patients undergoing transcatheter aortic valve replacement (TAVR). ...Background Western literature demonstrates a poor prognosis with paradoxical LF and low-flow low-gradient (LF-LG) severe aortic stenosis (AS), as defined by stroke volume index (SVi) <35 ml/m2 and mean pressure gradient <40 mm Hg with preserved left ventricular ejection fraction (LVEF). However, this poor prognosis is contested in Japan owing to the smaller body size of Japanese patients relative to that of Western patients. Additionally, there are no reports of the prognostic implication of paradoxical LF or LF-LG severe AS in small-body patients undergoing TAVR. Methods This was a retrospective analysis of 723 consecutive Japanese patients (median age 85 years; 32.6% male; median body surface area 1.4 m2 ) who underwent TAVR for severe AS at 9 sites in Japan. The primary and secondary endpoints were cumulative all-cause and cardiovascular mortality after TAVR, respectively. Results Ninety-seven (13.4%) patients had paradoxical LF severe AS whereas 38 (5.3%) had paradoxical LF-LG with severe AS. PLF was associated with a significant increase in all-cause (hazard ratio HR: 3.00; 95% confidence interval CI: 1.34 to 6.72; p < 0.001) and cardiovascular mortality (HR: 5.58; 95% CI: 1.19 to 26.2; p < 0.01), as compared with patients’ normal flow and preserved LVEF. PLF-LG was associated with a significant increase in all-cause mortality (HR: 3.76; 95% CI: 1.09 to 13.73; p < 0.01), as compared with normal flow high gradient with preserved LVEF. SVi was an independent predictor of cardiovascular mortality on multivariate analysis after adjustments for age, sex, clinically relevant variables, and other echocardiographic parameters (HR: 1.96; 95% CI: 1.19 to 3.23; p < 0.01). Conclusions Among Japanese small-body patients with severe AS, both paradoxical LF and LF-LG severe AS were associated with poor outcomes following TAVR. SVi was an independent predictor of cardiovascular mortality after TAVR. (Optimised Transcatheter Valvular Intervention registry OCEAN-TAVI; UMIN000020423 )
Initial and long-term outcomes of the retrograde endovascular approach using a microcatheter for the treatment of chronic total occlusion (CTO) in the iliac or femoropopliteal (FP) arteries have not ...been fully elucidated.
From 2012 to 2014, 20 consecutive patients (21 limbs) underwent endovascular therapy (EVT) for CTO in the iliac or FP arteries using the microcatheter-based retrograde approach. An analysis of the initial and long-term outcomes was conducted.
All procedures were successful. The mean follow-up duration was 27.4 ± 11.3 months. The mean patient age was 75.8 ± 9.1 years. Eighteen (85.7%) target lesions were located in the superficial femoral artery, 1 (4.8%) in the popliteal artery, and 2 (9.5%) in the iliac artery. All lesions were de novo. The mean occlusion length was 183.3 ± 95.4 mm. A stent was used in 19 (94.5%) lesions and balloon angioplasty was performed for 2 (5.5%) lesions. Retrograde puncture site complication (hematoma in popliteal artery) was reported in 1 (4.8%) patient. Postprocedure primary patency rates at 1, 2, and 3 years were 89.5%, 72.0%, and 41.2%, respectively, and the secondary patency rates at the corresponding time points were 100%, 77.2%, and 48.6%, respectively.
Initial and long-term outcomes of EVT for CTO in iliac and FP arteries using the microcatheter-based retrograde approach are promising.
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