Futoshi Yamanaka

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 &rgr;=−0.077, P=0.007), albumin (&rgr;=−0.22, P<0.001), gait speed (&rgr;=−0.28, P<0.001), and grip strength (&rgr;=−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.

Co-Existence of Carotid Artery Disease, Renal Artery Stenosis, and Lower Extremity Peripheral Arterial Disease in Patients With Coronary Artery Disease

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.

Impact of tissue prolapse after stent implantation on short- and long-term clinical outcomes in patients with acute myocardial infarction: An intravascular ultrasound analysis

BACKGROUND We used intravascular ultrasound (IVUS) to evaluate the association of tissue prolapse (TP) with short- and long-term outcomes after stent implantation in 418 acute myocardial infarction (AMI) patients. METHODS We evaluated the incidences of stent thrombosis, no-reflow, and long-term outcomes between patients with TP (n=142) and those without TP (n=276). RESULTS twb.42w?>Acute and subacute stent thromboses occurred more frequently in patients with TP compared with those without TP (3.5% vs. 0.7%, p=0.035, and 4.2% vs. 0.7%, p = 0.013, respectively). TP volumes in 14 patients with stent thrombosis were significantly greater than those in 128 patients without stent thrombosis (3.3 ± 1.6 mm(3) vs. 2.6 ± 1.9 mm(3), p=0.012). No-reflow was developed more frequently in patients with TP compared with those without TP (25.4% vs. 9.8%, p < 0.001). Creatine kinase-MB and cardiac-specific troponin I were elevated more significantly after stenting in patients with TP compared with those without TP (Δ=+9.0 ± 25.2 U/l vs. -4.2 ± 41.6 U/l, p=0.001 and Δ=+10.0 ± 43.5 ng/ml vs. -1.2 ± 35.6 ng/ml, p=0.005, respectively). There were no significant differences in the incidences of cardiac death, MI, and target vessel revascularization at 1-year. Multivariate analysis showed that TP was the independent predictor of composite of acute and subacute stent thromboses [odds ratio (OR) = 4.211; 95% CI 1.198-14.805, p = 0.025] and composite of acute stent thrombosis and no-reflow (OR = 2.551; 95% CI 1.315-4.952, p = 0.006). CONCLUSIONS TP was associated with poor short-term outcomes (more acute and subacute thromboses and no-reflow phenomenon), however it was not associated with worse long-term outcomes after stent implantation for infarct-related arteries in patients with AMI.

Pre-procedural dual antiplatelet therapy in patients undergoing transcatheter aortic valve implantation increases risk of bleeding.

Objective To evaluate the clinical benefit of pre-procedural antiplatelet therapy in patients undergoing transfemoral (TF) transcatheter aortic valve implantation (TAVI). Methods OCEAN (Optimized transCathEter vAlvular interveNtion)-TAVI is a prospective, multicentre, observational cohort registry, enrolling 749 patients who underwent TAVI from October 2013 to August 2015 in Japan. We identified 540 patients (median age 85 years, 68.1% female) undergoing TF-TAVI; of these, 80 had no pre-procedural antiplatelet therapy and 460 had antiplatelet therapy. The endpoints were any bleeding (life-threatening, major, and minor bleeding) and thrombotic events (stroke, myocardial infarction, and valve thrombosis) during hospitalisation. Results Patients with dual antiplatelet therapy (DAPT) had a significantly higher incidence of any bleeding than those with single antiplatelet therapy (SAPT) (36.5% vs 27.5%, p=0.049) and no antiplatelet therapy (36.5% vs 21.3%, p=0.010). Patients without pre-procedural antiplatelet therapy did not experience an increased risk of thrombotic events. In multivariable logistic regression analysis, DAPT before TF-TAVI significantly increased any bleeding compared with SAPT (OR 2.05, 95% CI 1.16 to 3.65) and no antiplatelet therapy (OR 2.30, 95% CI 1.08 to 4.90). Conclusions The current study demonstrated that DAPT before TF-TAVI increased the risk of bleeding compared with single or no antiplatelet therapy. Lower intensity antiplatelet therapy was not associated with thrombotic events. In modern practice, it might be reasonable to perform TAVI using single or no pre-procedural antiplatelet therapy with an expectation of no increase of adverse events. Trial registration number UMIN-ID; 000020423; Results.

Comparison of clinical outcomes between octogenarians and non-octogenarians with acute myocardial infarction in the drug-eluting stent era: Analysis of the Korean Acute Myocardial Infarction Registry

BACKGROUND AND PURPOSE Octogenarians (age ≥ 80 years) with coronary artery disease constitute a high-risk group. However, octogenarian patients with acute myocardial infarction (AMI) in the drug-eluting stents (DES) era have not been widely reported. We aimed to identify clinical outcomes in octogenarian compared with non-octogenarian AMI patients. METHODS AND SUBJECTS We retrospectively analyzed 9877 patients who underwent percutaneous coronary intervention (PCI) with drug-eluting stents (DES) and who were enrolled in the Korean Acute Myocardial Infarction Registry (KAMIR). They were divided into 2 groups, octogenarians (n=1494) and non-octogenarians (n=8383), in order to compare the incidence of 1-year all-cause death and 1-year major adverse cardiac events (MACE), where MACE included all-cause death, recurrent myocardial infarction, target vessel revascularization (TVR), target lesion revascularization (TLR), and coronary artery bypass grafting (CABG). RESULTS The clinical status was significantly inferior in octogenarians compared to non-octogenarians: Killip class ≥ II (34.8% vs. 22.5%, p<0.001), multivessel disease (65.8% vs. 53.7%, p<0.001). Rates of 1-year all-cause death were significantly higher in octogenarians than in non-octogenarians (22.3% vs. 6.5%, p<0.001). However, the rates of 1-year recurrent myocardial infarction (1.3% vs. 0.9%, p=0.68), TLR (2.4% vs. 3.1%, p=0.69), TVR (3.6% vs. 4.3%, p=0.96), and CABG (0.9% vs. 0.9%, p=0.76) did not differ significantly between the 2 groups. CONCLUSIONS Octogenarian AMI patients have higher rates of mortality and MACE even in the DES era. According to KAMIR subgroup analysis, the TLR/TVR rates in octogenarians were comparable to those in non-octogenarian AMI patients.

Comparison of Short- and Long-Term Outcomes of Percutaneous Coronary Intervention for Chronic Total Occlusions Between Patients Aged ≥75 Years and Those Aged <75 Years

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.

Prehospital Transfer Pathway and Mortality in Patients Undergoing Primary Percutaneous Coronary Intervention

BACKGROUND It is recommended that not only door-to-balloon time but also prehospital delay for primary percutaneous coronary intervention (PCI) should be improved. We investigated the effect of prehospital transfer pathway on onset-to-balloon time and prognosis in patients with ST-segment elevation myocardial infarction (STEMI) in Japan. METHODSANDRESULTS We analyzed data from 540 consecutive patients with primary PCI for STEMI. Patient clinical data and mortality were compared between patients who visited the family physician or non-PCI-capable hospitals and were then transferred to PCI-capable centers (indirect transfer patients), and those who directly visited PCI-capable centers (direct transfer patients). Onset-to-balloon time was longer in indirect transfer patients than in direct transfer patients (mean, 270 min; range, 180-480 min vs. 180 min, 120-240 min; P<0.001). In addition, patient prognosis was evaluated on Cox proportional regression analysis. Cardiac death and all-cause death were significantly higher in indirect transfer patients (odds ratios [OR], 2.17; 95% confidence intervals [95% CI]: 1.17-4.01, P=0.01; OR, 1.71; 95% CI: 1.09-2.68, P=0.02). These results were confirmed using propensity score matching for adjusted analyses. CONCLUSIONS Patients with indirect transfer to regional emergency departments of PCI centers had longer onset-to-balloon time and worse prognosis than those with direct transfer.

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.

Elevation of B-type natriuretic peptide at discharge is associated with 2-year mortality after transcatheter aortic valve replacement in patients with severe aortic stenosis: Insights from a multicenter prospective OCEAN-TAVI (Optimized Transcatheter Valvular Intervention-Transcatheter Aortic Valve Implantation) registry

Background In this study, we sought to investigate the 2‐year prognostic impact of B‐type natriuretic peptide (BNP) levels at discharge, following transcatheter aortic valve replacement. Methods and Results We enrolled 1094 consecutive patients who underwent transcatheter aortic valve replacement between 2013 and 2016. Study patients were stratified into 2 groups according to survival classification and regression tree analysis (high versus low BNP groups). We evaluated the impact of high BNP on 2‐year mortality compared with that of low BNP using a multivariable Cox model, and assessed whether this stratification would improve predictive accuracy for determining 2‐year mortality by assessing time‐dependent net reclassification improvement and integrated discrimination improvement. The median age of patients was 85 years (quartile 82–88), and 29.2% of the study population were men. The median Society of Thoracic Surgeons score was 6.8 (4.7–9.5), and BNP at discharge was 186 (93–378) pg/mL. All‐cause mortality following discharge was 7.9% (95% CI, 5.8–9.9%) at 1 year and 15.4% (95% CI, 11.6–19.0%) at 2 years. The survival classification and regression tree analysis revealed that the discriminating BNP level to discern 2‐year mortality was 202 pg/mL, and that elevated BNP had a statistically significant impact on outcomes, with an adjusted hazard ratio of 2.28 (1.36–3.82, P=0.002). The time‐dependent net reclassification improvement (P=0.047) and integrated discrimination improvement (P=0.029) analysis revealed that the incorporation of BNP stratification with other clinical variables significantly improved predictive accuracy for 2‐year mortality. Conclusions Elevation of BNP at discharge is associated with 2‐year mortality after transcatheter aortic valve replacement.

Propensity-matched comparison of percutaneous and surgical cut-down approaches in transfemoral transcatheter aortic valve implantation using a balloon-expandable valve

AIMS This study aimed to compare the clinical outcomes of patients undergoing transfemoral transcatheter aortic valve implantation (TAVI) via a percutaneous or surgical cut-down approach. METHODS AND RESULTS Between October 2013 and July 2015, 586 patients underwent transfemoral TAVI according to the Optimized CathEter vAlvular iNtervention (OCEAN)-TAVI registry (percutaneous approach, n=305; surgical cut-down approach, n=281). After propensity matching, 166 patients underwent transfemoral TAVI via each approach. Major vascular complications, as defined per the Valve Academic Research Consortium-2 criteria, were found less frequently in patients who underwent a percutaneous approach (15.1% vs. 27.1%, p<0.01), and femoral artery injuries requiring surgical repair were mostly the result of a closure device failure (seven cases, 4.2%). In these patients, major bleeding was less (7.2% vs. 16.9%, p=0.01) and blood transfusion less frequent (21.1% vs. 38.0%, p<0.01); therefore, cases of acute kidney injury (AKI) were rare (6.0% vs. 15.1%, p<0.01). CONCLUSIONS Transfemoral TAVI using the percutaneous approach proved safe and feasible and resulted in fewer major vascular complications, bleeding and AKI events compared to the surgical cut-down approach.