Tissue responses to everolimus-eluting stents implanted in severely calcified lesions following atherectomy.

Histopathological examination has revealed that stents on severely calcified plaques were associated with delayed vascular healing. Although atherectomy devices can increase the number of malapposed struts, tissue responses to implanted drug eluting stents in atherectomy patients remain largely unknown. This retrospective observational study included 30 patients who underwent atherectomy and everolimus-eluting stent (EES) deployment for severely calcified coronary lesions (biodegradable polymer EES (BP-EES), n = 15; durable polymer EES (DP-EES), n = 15). Optical coherence tomography was carried out at baseline and follow-up, and struts with acute stent malapposition (ASM) were categorized as struts on modified calcium (mod-Ca), non-modified calcium (non-mod-Ca), or non-calcium (non-Ca). Adequate vascular healing, defined as ASM resolution with neointimal coverage, was compared between the BP-EES and DP-EES groups. Multivariate linear regression analysis using a generalized estimated equation revealed that BP-EES use was associated with significantly better adequate vascular healing compared with DP-EES (odds ratio [OR]: 3.691, 95% confidence interval [CI] 1.175-11.592, P = 0.025). adequate vascular healing was associated with the underlying plaque morphology (mod-Ca vs non-mod-Ca: OR 2.833, 95% CI 1.491-5.384, P = 0.001; non-Ca vs non-mod-Ca: OR 1.248, 95% CI 0.440-3.543, P = 0.677). This study demonstrates that drug-eluting stent selection and calcium modification are possible factors affecting vascular healing of malapposed struts in severely calcified lesions.

Vascular access site complications after transfemoral transcatheter aortic valve implantation: a comparison of open and percutaneous puncture approaches.

Background: In transfemoral transcatheter aortic valve implantation (TF-TAVI), which approach has lower vascular access site complications between the open puncture (OP) and percutaneous puncture (PP) approaches is still controversial. Moreover, few studies have analyzed risk factors for vascular access site complications in TF-TAVI. This study aimed to compare vascular access site complications between the OP and PP approaches in patients undergoing TF-TAVI and access risk factors for vascular access site complications. Methods: Three hundred fifty-one patients who underwent TF-TAVI via the PP (n=251) and OP (n=100) were retrospectively examined. Results: Incidence of vascular access site complications was 7.0% in the OP group and 8.4% in the PP group (P=0.828). Two deaths from vascular access site complications occurred in the PP group. After performing inverse probability weighting (IPW), regression analysis showed that PP was associated with a significantly higher odds of vascular access site complications [odds ratio =2.033; 95% confidence interval (CI): 1.397-2.958; P<0.001]. Common femoral artery (CFA) depth (hazard ratio =1.04; 95% CI: 1.000-1.070; P=0.045) and sheath/CFA diameter ratio (hazard ratio =971; 95% CI: 22.6-41,700; P<0.001) were independent complication risk factors. In patients with CFA depth ≥35 mm, the incidence of vascular access site complications was higher with PP than OP. Sheath/CFA diameter ratio ≥0.9 was associated with increased risk of vascular injury with both approaches. Conclusions: The incidence of vascular access site complications in patients undergoing TF-TAVI was significantly lower with OP than PP after IPW. OP may be preferable when CFA depth is ≥35 mm. When the sheath/CFA diameter ratio is ≥0.9, approaches other than the TF approach should be considered.

Impact of cystatin C-derived glomerular filtration rate in patients undergoing transcatheter aortic valve implantation.

Background: Chronic kidney disease (CKD) impacts prognosis in patients undergoing transcatheter aortic valve implantation (TAVI). While estimated glomerular filtration rate (eGFR) calculated from serum creatinine [eGFR (creatinine)] is affected by body muscle mass which reflects frailty, eGFR calculated from serum cystatin C [eGFR (cystatin C)] is independent of body composition, resulting in better renal function assessment. Methods: This study included 390 consecutive patients with symptomatic severe aortic stenosis (AS) who underwent TAVI, and measured cystatin C-based eGFR at discharge. Patients were divided into two groups, with or without CKD estimated with eGFR (cystatin C). The primary endpoint of this study was the 3-year all-cause mortality after TAVI. Results: The median patient age was 84 years, and 32.8% patients were men. Multivariate Cox regression analysis indicated that eGFR (cystatin C), diabetes mellitus, and liver disease were independently associated with 3-year all-cause mortality. In the receiver-operating characteristic (ROC) curve, the predictive value of eGFR (cystatin C) was significantly higher than that of eGFR (creatinine). Furthermore, Kaplan-Meier estimates revealed that 3-year all-cause mortality was higher in the CKD (cystatin C) group than that in the non-CKD (cystatin C) group with log-rank p = 0.009. In contrast, there was no significant difference between the CKD (creatinine) and non-CKD (creatinine) groups with log-rank p = 0.94. Conclusions: eGFR (cystatin C) was associated with 3-year all-cause mortality in patients who underwent TAVI, and it was superior to eGFR (creatinine) as a prognostic biomarker.

Iatrogenic Atrial Septal Defect Requiring Transcatheter Closure Following Transcatheter Mitral Valve Repair.

BACKGROUND: Transcatheter mitral valve repair with the MitraClip system has been established in selected high-risk patients. The MitraClip procedure results in a relatively large iatrogenic atrial septal defect (iASD). This study aimed to investigate the prevalence and clinical course of iASD requiring transcatheter closure following the MitraClip procedure.Methods and Results: This study was conducted at all 59 institutions that perform transcatheter mitral valve repair with the MitraClip system in Japan. The data of patients on whom transcatheter iASD closure was performed were collected. Of the 2,722 patients who underwent the MitraClip procedure, 30 (1%) required transcatheter iASD closure. The maximum iASD size was 9±4 mm (range, 3-18 mm). The common clinical course of transcatheter iASD closure was hypoxemia with right-to-left shunt or right-sided heart failure with left-to-right shunt. Of the 30 patients, 22 (73%) required transcatheter closure within 24 h following the MitraClip procedure, including 12 with hypoxemia and 5 with right-sided heart failure complicated with cardiogenic shock. Of the 5 patients, 2 required mechanical circulatory support devices. Twenty-one patients immediately underwent transcatheter iASD closure, and hemodynamic deteriorations were resolved; however, 1 patient died without having undergone transcatheter closure. CONCLUSIONS: Transcatheter iASD closure was required in 1% of patients who underwent the MitraClip procedure. Many of these patients immediately underwent transcatheter iASD closure because of hypoxemia with right-to-left shunt or right-sided heart failure with left-to-right shunt.

Left atrial volume index predicts future improvement of B-type natriuretic peptide levels after transcatheter aortic valve replacement.

In patients with symptomatic severe aortic stenosis (AS), those who experienced readmission due to heart failure after transcatheter aortic valve replacement (TAVR) showed poor prognosis. Furthermore, poor B-type natriuretic peptide (BNP) improvement is associated with increased morbidity and mortality. However, little is known about the clinical parameters related to the change in BNP levels after TAVR procedure. This study population consisted of 127 consecutive patients of symptomatic severe AS with preserved ejection fraction (EF) who underwent transfemoral TAVR (TF-TAVR). Comprehensive transthoracic echocardiography was performed prior to the day of TF-TAVR. BNP was measured serially before and 1 year after TF-TAVR. The median BNP level was significantly decreased from 252.5 pg/ml to 146.8 pg/ml in all 127 patients 1 year after TF-TAVR (P < 0.01). However, the patients could be divided into 2 groups according to decrease (72%) or increase (28%) in plasma BNP level. Multivariate logistic regression analysis revealed that Aortic valve (AV) peak velocity, pre-procedural BNP, and larger left atrial volume index (LAVI) were found to be an independent predictor of increased BNP level 1 year after TAVR (OR 0.55, 95% CI 0.38-0.77; P < 0.01). LAVI were negatively correlated with the change in BNP level before and 1 year after TAVR (r = 0.47, P < 0.01). The ROC analysis demonstrated that 52.9 ml/m2 was the optimal cut-off value of LAVI for decreasing BNP 1 year after TAVR (area under the curve 0.69) with 64% sensitivity and 70% specificity. In addition to AV peak velocity and pre-procedural BNP, LAVI independently predicts future improvement of BNP levels 1 year after TAVR. Our findings indicate an additive predictive value of assessment of LAVI before TAVR procedure for risk stratification.

Angioscopic Ulcerated Plaques in the Femoropopliteal Artery Associated with Impaired Infrapopliteal Runoff.

PURPOSE: To determine the correlation between upstream atherosclerosis in the femoropopliteal arteries, assessed using angioscopy, and impaired infrapopliteal runoff. MATERIALS AND METHODS: Thirty-one patients with peripheral arterial disease who underwent endovascular therapy and angioscopy were prospectively included. Yellow plaque color scores were semiquantitatively determined as 0, 1, 2, or 3. Irregular plaques with rough surfaces, similar to gastric ulcers, were defined as ulcerated plaques (UPs). Angioscopic data were correlated with angiographic runoff scores (ARS). RESULTS: UPs were detected in 74.2% of enrolled diseased legs using angioscopy. Mural thrombi were more commonly observed in the femoropopliteal artery in patients with UPs than in those without UPs (91.3% vs 37.5%, respectively; P = .006) and were frequently found on the UPs (21/23 patients with UPs). Univariate and multivariate linear regression analyses revealed that the presence of UPs was positively and independently associated with a poor ARS and that oral anticoagulant use was independently associated with a preferable ARS (standardized ß = 0.462, P = .004 and standardized ß = -0.411, P = .009, respectively, in the multivariate analysis). CONCLUSIONS: UPs, associated with mural thrombi and diagnosed by angioscopic examination, were demonstrated to be one of the factors associated with poor infrapopliteal runoff.

Kihon checklist is useful for predicting outcomes in patients undergoing transcatheter aortic valve implantation.

BACKGROUND: Frailty is a major risk factor for death and disability following transcatheter aortic valve implantation (TAVI). The Kihon checklist (KCL) is a simple self-reporting yes/no survey consisting of 25 questions and is used as a screening tool to identify frailty in the primary care setting. No clinical studies have focused on frailty calculated by the KCL in the TAVI cohort. We investigated the 3-year prognostic impact of frailty evaluated by the KCL in patients who underwent TAVI. METHODS: This single-center prospective observational study included 280 consecutive patients with symptomatic severe aortic stenosis who underwent TAVI and evaluated pre-procedural physical performance focused on frailty at our institution. We assessed all patients' frailty by the KCL before TAVI, as described previously. We set the primary endpoint as the 3-year all-cause mortality after TAVI. RESULTS: The median patient age was 84 years (interquartile range, 81-87 years), and 31.1% were men. In the receiver operating characteristics curve, there were no significant differences between the KCL and Cardiovascular Health Study frailty index [area under the curve (AUC) 0.625 versus 0.628; p=0.93), KCL and Rockwood Clinical Frailty Scale (AUC 0.625 versus 0.542; p=0.15), and KCL and Short Physical Performance Battery (AUC 0.625 versus 0.612; p=0.91). The first and second tertiles of the total KCL score were 8 and 12, respectively. The multivariate Cox regression model indicated that the total KCL score [hazard ratio (HR), 1.104; 95% confidence interval (CI), 1.034-1.179; p=0.003], presence of diabetes mellitus (HR, 1.993; CI, 1.055-3.766; p=0.03), and presence of liver disease (HR, 3.007; CI, 1.067-8.477; p=0.04) were independently associated with 3-year all-cause mortality. CONCLUSIONS: The KCL is a simple and useful tool for evaluating frailty status and predicting 3-year all-cause mortality in patients undergoing TAVI.

Academic Research Consortium High Bleeding Risk Criteria associated with 2-year bleeding events and mortality after transcatheter aortic valve replacement discharge: a Japanese Multicentre Prospective OCEAN-TAVI Registry Study.

Aims: To investigate the ability of the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria and ARC-HBR score to predict 2-year bleeding and mortality in patients undergoing transcatheter aortic valve replacement (TAVR). Methods and results: We enrolled 2514 patients who underwent successful TAVR during 2013-17. In this study, we used the ARC-HBR score for further HBR-risk stratification, and the ARC-HBR score was calculated as follows: each major criterion was 2 points and each minor criterion was 1 point. The impact of the ARC-HBR criteria and increasing ARC-HBR score on the incidence of moderate/severe bleeding events, mortality, and ischaemic stroke in the first 2 years were evaluated. We used survival classification and regression tree (CART) analysis for 2-year moderate or severe bleeding events, and patients were statistically classified into HBR low- (ARC-HBR score ≤1), intermediate- (ARC-HBR score = 2-4), or high-risk (ARC-HBR score ≥5) groups, and 91.4% were at HBR (ARC-HBR score ≥2). The rates of 2-year moderate/severe bleeding events and all-cause mortality were higher in the ARC-HBR group and highest in the HBR high-risk group. An increased HBR score was significantly associated with moderate/severe bleeding events [hazard ratio (HR) 1.19, 95% confidence interval (CI) 1.07-1.31; P = 0.001] and all-cause mortality (adjusted HR 1.24, 95% CI 1.17-1.32; P < 0.001). Conclusions: The ARC-HBR criteria identify patients at HBR after TAVR; an increased ARC-HBR score is associated with 2-year moderate/severe bleeding events and mortality.

Relationship of high-intensity plaques on T1-weighted magnetic resonance imaging with coronary intraplaque hemorrhage: A directional coronary atherectomy study.

Background: Although intraplaque hemorrhage (IPH) has been identified as a key feature of rupture-prone plaques, noninvasive imaging-based features for its detection in coronary artery have not been clearly established. The aim of this study was to investigate the relationship of the ratio between the signal intensities of coronary plaque and cardiac muscle (PMR) on non-contrast T1-weighted imaging (T1WI) in magnetic resonance with IPH in the directional coronary atherectomy (DCA) specimens. Methods: Fifteen lesions from 15 patients, who underwent DCA and T1WI, were prospectively enrolled. The snap-frozen samples obtained by DCA were used for immunohistochemical staining against a protein specific to erythrocyte membranes (glycophorin A) and macrophages. The percentage of glycophorin A and macrophages was graded using a scale from 0 to 4, with higher scores indicating higher percentages. Results: PMR showed a strong positive correlation with glycophorin A scores (ρ = 0.772, p < 0.001), whreas, there was a weak correlation between the PMR and macrophage scores (ρ = 0.626, p < 0.05). The receiver-operating characteristic curve analysis showed that the optimal PMR cutoff value for predicting glycophorin A scores ≥grade 2 (glycophorin A-positive area ≥5% of the plaque) was 1.2 (area under the curve; 0.91, 95% confidence interval; 0.73-1.00), and this PMR value had a sensitivity of 8/9 (89%), specificity of 6/6 (100%), positive predictive value of 8/8 (100%), and negative predictive value of 6/7 (86%). Conclusions: In patients with ischemic heart disease, a high PMR on T1WI is a predictor of coronary IPH as assessed by DCA specimens.

Presence of mitral stenosis is a risk factor of new development of acute decompensated heart failure early after transcatheter aortic valve implantation.

AIMS: Acute decompensated heart failure (ADHF) can occur early after transcatheter aortic valve implantation (TAVI), but the risk factors or mechanisms associated with it have not been fully determined. This hypothesis-generating study aimed to investigate the clinical indices associated with the development of ADHF within 72 hours after TAVI and to improve procedural approaches for TAVI. METHOD AND RESULTS: In this single-centre hypothesis generating prospective observational study, we enrolled 156 consecutive patients with severe aortic stenosis who underwent TAVI between January 2016 and February 2018 at our institution. We set the primary endpoint as the new development of ADHF within 72 hours after TAVI, and clinical indices associated with it were evaluated using a multivariable logistic model. The median age of the patients was 83 (quartile range 80-86) years, 48 (30.8%) were men and the median Society of Thoracic Surgery-Predicted Risk of Mortality was 7.1 (range 5.2-10.4). Mitral stenosis (MS), defined as mean transmitral valve pressure gradient ≥5 mm Hg, was present in 15 (9.6%) patients. After TAVI, the invasive mean transaortic valve pressure gradient (mAVPG) decreased from 48 (36-66) to 7 (5-11) mm Hg, and 12 (7.7%) patients developed ADHF within 72 hours after TAVI. Multivariable logistic regression analysis showed that MS (adjusted OR, 14.227; 95% CI 2.654 to 86.698; p=0.002) and greater decreases in mAVPG (1.038; 1.003 to 1.080; p=0.044) were associated with ADHF. CONCLUSIONS: MS and drastic improvement of mAVPG were associated with new development of ADHF within 72 hours after TAVI.

Association between debulking area of rotational atherectomy and platform revolution speed-Frequency domain optical coherence tomography analysis.

OBJECTIVES: In this study, we sought to investigate the association between revolution speed of rotational atherectomy (RA) and debulking area assessed by frequency domain-optical coherence tomography (FD-OCT). BACKGROUND: The number of patients with severe calcified coronary artery disease requiring treatment with calcium ablation, such as RA, is increasing. However, there is little evidence available regarding the association between debulking area and revolution speed during RA. METHODS: We retrospectively investigated 30 consecutive severely calcified coronary lesions in 29 patients who underwent RA under FD-OCT guidance. The association between preset revolution speed of RA and burr size-corrected debulking area of the calcified lesion was evaluated using a multivariable regression model with nonlinear restricted-cubic-spline, which can help assess nonlinear associations between variables. RESULTS: The median age of study participants was 73 years (quartile 65-78); 82.8% were male. The median burr size was 1.5 mm (1.5-1.75); median total duration of ablation was 120 s (100-180). FD-OCT revealed that the post-procedural minimum lumen area increased significantly from 1.64 mm2 (1.40-2.09) to 2.45 mm2 (2.11-2.98) (p < .001). In addition, the burr size-corrected debulking area increased significantly as the preset revolution speed decreased (p = .018), especially when the revolution speed was less than 150,000 rpm. This result implies that additional lumen gain will be obtained by decreasing rpm when the burr speed is set at <150,000 rpm. CONCLUSIONS: FD-OCT demonstrated that RA with lower revolution speed, below 150,000 rpm, has the potential to achieve greater calcium debulking effect in patients with severe calcified coronary lesions.

Self-expandable transcatheter aortic valve replacement is associated with frequent periprocedural stroke detected by diffusion-weighted magnetic resonance imaging.

BACKGROUND: Little evidence is available regarding the risk of peri-procedural stroke detected by diffusion-weighted magnetic resonance imaging (DW-MRI) after transcatheter aortic valve replacement (TAVR). Our purpose was to evaluate stroke risk after TAVR using DW-MRI by enrolling consecutive patients who underwent transfemoral TAVR and post-procedural DW-MRI. METHODS: We prospectively enrolled 113 consecutive patients who underwent transfemoral TAVR and post-procedural DW-MRI. We used balloon-expandable valves as first-line therapy and selected self-expandable valves only for patients with narrow sinotubular junctions or annuli. We set the primary endpoint as the number of high intensity areas (HIA) detected by DW-MRI regardless of the size of the area. To evaluate the risks of the primary endpoint, we employed a multivariable linear regression model, setting the primary endpoint as an objective variable and patient and clinical backgrounds as explanatory variables. RESULTS: Median patient age was 84 years, and 36.3% were men. Ninety-three patients underwent balloon-expandable TAVR and 20 underwent self-expandable TAVR. Symptomatic stroke occurred in 6 (5.3%) whereas asymptomatic stroke occurred in 59 (52.2%) patients. The incidence of symptomatic and total stroke was higher in patients who underwent self-expandable TAVR than those who underwent balloon-expandable TAVR (30.0% vs. 0.0%, p<0.001 and 90.0% vs. 50.5%, p=0.001, respectively). A multivariable linear regression model demonstrated an increased primary endpoint when self-expandable TAVR was performed (p<0.001). The other covariates had no significant relationship to the primary endpoint. Akaike information criterion-based stepwise statistical model selection revealed that valve type was the only explanatory variable for the best predictive model. CONCLUSIONS: Self-expandable valves were associated with increased numbers of HIA on DW-MRI after TAVR in patients with severe aortic stenosis.

Is elevation of N-terminal pro-B-type natriuretic peptide at discharge associated with 2-year composite endpoint of all-cause mortality and heart failure hospitalisation after transcatheter aortic valve implantation? Insights from a multicentre prospective OCEAN-TAVI registry in Japan.

OBJECTIVES: The aim of this study was to investigate the 2-year prognostic impact of N-terminal pro-B-type natriuretic peptide (NT-proBNP) levels at discharge following transcatheter aortic valve implantation (TAVI). DESIGN: Multicentre prospective observational study. SETTINGS: Seven institutions from multicentre, observational registry of symptomatic patients with severe aortic stenosis who undergo TAVI. PARTICIPANTS: We enrolled 500 consecutive patients who underwent TAVI with measurements of NT-proBNP at discharge between 2013 and 2016. Study patients were stratified into two groups according to survival classification and regression tree (CART) analysis: high versus low NT-proBNP groups. INTERVENTIONS: The impact of high NT-proBNP on a 2-year composite endpoint consisting of all-cause mortality and heart failure hospitalisation was evaluated using a multivariable Cox model. RESULTS: Median age was 86 years (quartile 82-89), and 24.2% of the study population were men. Median Society of Thoracic Surgeon score was 7.1 (5.1-9.8), and NT-proBNP at discharge was 1381 (653-3136) pg/mL. The composite endpoint incidence was 13.0% (95% CI 9.5% to 16.3%) at 1 year and 22.3% (95% CI 16.1%-27.9%) at 2 years. The survival CART analysis revealed that the NT-proBNP level required to discern the 2-year composite endpoint was 4288 pg/mL. Elevated NT-proBNP had a statistically significant impact on outcomes, with adjusted HR of 2.21 (95% CI 1.21 to 4.04, p=0.010), and with a significant sex difference (P for interaction=0.003). CONCLUSION: Elevation of NT-proBNP at discharge is associated with higher incidence of the 2-year composite endpoint after TAVI. TRIAL REGISTRATION NUMBER: 000020423.

Life-threatening pulmonary embolism associated with multiple venous aneurysms.

Popliteal venous aneurysms (PVAs) are often reported as a cause of pulmonary embolism. Previous reports documented the association between a single PVA and pulmonary embolism. We experienced a rare case with multiple venous saccular and fusiform aneurysms resulting in a nearly fatal pulmonary embolism. Surgical ligation is usually considered the first-line treatment for PVAs. In our patient, however, we selected inferior vena cava filter implantation and anticoagulant therapy to avoid the phlegmasia cerulea dolens caused by ligation of multiple aneurysms in both legs. We report a patient with multiple venous aneurysms, including PVAs, causing a nearly fatal pulmonary embolism.