Abstract Background Percutaneous coronary interventions involving small coronary vessels represent a true challenge because of the increased risk of restenosis and adverse outcomes. We evaluated the ...2-year clinical outcomes between single everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES) in small coronary artery disease. Methods From the data of SACRA (SmAll CoronaRy Artery treated by TAXUS Liberté) and PLUM (PROMUS/Xience V Everolimus-ELUting Coronary Stent for sMall coronary artery disease) registries, 245 patients with 258 lesions and 264 patients with 279 lesions, respectively, were enrolled in this study. Results The 2-year clinical driven target lesion revascularization (4.5% vs. 10.6%, p = 0.01) and target vessel revascularization (8.0% vs. 13.9%, p = 0.03) rates were significantly lower in the EES group compared with the PES group. Major adverse cardiac events in the EES group tended to be lower than those in the PES group (8.7% vs. 14.3%, p = 0.05). On the other hand, all new lesions for remote target vessel revascularization were observed at the proximal site of target lesions in both groups and those rates were not different between the two groups (3.4% vs. 3.3%, p > 0.99). Conclusion EES showed better clinical results at 2-year follow-up compared with PES in small coronary artery diseases, however, new lesions at the proximal remote site of the target lesion remain problematic.
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 Background Catheter ablation can reduce episodes of ventricular tachycardia (VT) after myocardial infarction (MI). However, the optimal endpoint of the ablation procedure remains unclear. ...Methods Fifty-one consecutive patients who received catheter ablation for VT after MI were included. The procedures targeted the isthmus of all the induced, sustained VTs. When the patients with induced VTs were hemodynamically stable, radiofrequency energy was delivered at the mid-diastolic potential recording site during VT. When the patients with VTs were hemodynamically unstable, the critical channel was identified at the delayed potential recording site, showing a good pace map, with a long stimulus-QRS interval. We delivered radiofrequency energy along the identified isthmus and across the exit of the circuit. Results At the end of the procedure, all VTs became non-inducible in 30 patients (59%) and some VTs were inducible in 21 patients (41%). During a mean of 40±29 months of follow-up, no VT or ventricular fibrillation recurred in 24 patients (80%) in the non-inducible group and in 12 patients (57%) in the inducible group, respectively ( P =0.03). The identification of the channel during VT mapping tended to associate with no recurrence, although the difference was not statistically significant ( P =0.2). Fourteen patients (27%) died during the follow-up period, mostly due to non-cardiac causes. Conclusions The catheter ablation targeting the isthmus of prior-MIVT and non-inducibility at the end of the procedure can provide a satisfactory follow-up result.
Abstract Objectives This study sought to assess the incidence and clinical impact of stent fracture (SF) after the PROMUS Element platinum-chromium everolimus-eluting stent (PtCr-EES). Background SF ...remains an unresolved, clinically relevant issue, even in the newer-generation drug-eluting stent era. Methods From March 2012 to August 2013, 816 patients with 1,094 lesions were treated only with PtCr-EES and 700 patients (85.7%) with 898 lesions undergoing follow-up angiography within 9 months after the index procedure were analyzed. SF was defined as complete or partial separation of the stent, as assessed by plain fluoroscopy, intravascular ultrasound, or optical coherence tomography during the follow-up. We assessed the rate of SF and the cumulative incidence of clinically driven target lesion revascularization and definite stent thrombosis within 9 months after the index procedure. Results SF was observed in 16 of 898 lesions (1.7%) and 16 of 700 patients (2.2%). Lesions with in-stent restenosis at baseline (odds ratio OR: 14.2, 95% confidence intervals CI: 5.09 to 39.7; p < 0.001) or hinge motion (OR: 4.31, 95% CI: 1.12 to 16.5; p = 0.03), and total stent length (per 10-mm increase; OR: 1.32, 95% CI: 1.12 to 1.57; p = 0.001) were predictors of SF. Cumulative incidence of clinically driven target lesion revascularization within 9-months was numerically higher in the SF group than that in the non-SF group (18.7% vs. 2.3%). Cumulative incidence of definite stent thrombosis within 9 months after the index procedure was similar between the SF and non-SF groups (0.0% vs. 0.23%). Conclusions SF after PtCr-EES occurs in 1.7% of lesions and appears to be associated with clinically driven target lesion revascularization.
The incidence and long-term clinical impact of stent fracture (SF) occurred beyond 1 year after sirolimus-eluting stent (SES) implantation remains unclear. From April 2004 to March 2008, 985 ...consecutive patients with 1,307 lesions were treated only with SES. Of these, 868 patients (88.1%) with 1,140 lesions underwent follow-up angiography within 1 year after the index procedure, and 646 patients (65.6%) with 872 lesions underwent it both within and beyond 1 year after the index procedure. According to the diagnosed timing of SF, we divided the patients into the 2 groups: early SF (<1 year after the index procedure) and late-acquired SF (>1 year after the index procedure). Early- and late-acquired SFs were observed in 64 of 868 patients (7.4%) and 66 of 1,140 lesions (5.8%); 12 of 646 patients (1.9%) and 12 of 872 lesions (1.4%), respectively. Cumulative 10-year incidence of clinically driven target lesion revascularization and definite stent thrombosis were numerically higher in the early- and late-acquired SF groups than in the non-SF group (41.6% vs 45.5% vs 19.0%; 8.0% vs 8.3% vs 2.0%, respectively). In conclusion, late-acquired SF after SES implantation occurred in 1.4% of lesions, which was lower than that of early SF. However, both early- and late-acquired SFs appeared to be associated with clinically driven target lesion revascularization and stent thrombosis during the long-term follow-up.
Abstract Background Dipeptidyl peptidase-4 (DPP-4) inhibitors have anti-atherosclerotic and cardioprotective effects in vitro. However, the impact of DPP-4 inhibitors on coronary plaque remains ...unclear. We sought to assess the effect of sitagliptin on coronary plaque volume (PV) and stabilization in diabetic patients with acute coronary syndrome (ACS). Methods The ESPECIAL-ACS was a prospective, randomized, open-label, parallel group study at 4 Japanese centers to assess the effect of 6-month treatment with sitagliptin on coronary plaque changes in non-culprit lesion in diabetic patients with ACS using serial intravascular ultrasound (IVUS) and integrated backscatter IVUS (IB-IVUS) analysis. Results A total of 41 patients were randomly allocated to either sitagliptin group (diet and exercise with sitagliptin 50–100 mg daily, n = 21) or control group (diet and exercise, n = 20) within 72 h after percutaneous coronary intervention, and underwent volumetric IVUS and IB-IVUS analyses at baseline and 6-month follow-up. At 6-month follow-up, the percent change in PV as primary endpoint was larger in the sitagliptin group than in the control group, but the difference was not statistically significant (−4.0 ± 8.5% vs. −1.4 ± 8.8%, p = 0.35). In IB-IVUS analysis, the percent change in lipid PV significantly decreased in the sitagliptin group compared with the control group (−7.1 ± 21.5% vs. 15.6 ± 41.8%, p = 0.03). Conclusions Compared with diet and exercise therapy, sitagliptin did not significantly reduce coronary PV in diabetic patients with ACS at 6-month follow-up. However, the percent change in lipid PV significantly decreased in the sitagliptin group, suggesting that sitagliptin has a potential to stabilize the plaque vulnerability.
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 )
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