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Although various devices and strategies were introduced into endovascular therapy, factors associated with chronic outcomes remain unclear. Therefore, this study aimed to build preliminary data of Japanese femoropopliteal lesions in a period of transition from non-drug to drug technology. This research was a multicenter, prospective, and observational study. A total of 1003 consecutive patients with a mean age of 73.6 ± 8.3 years from 67 institutes were registered from February 2017 to June 2018 in Japan. In addition to the baseline data, angiographic findings affecting primary patency were studied. Lesion length was 16.4 ± 9.6 cm, and chronic total occlusion was found in 42%. Calcified lesions were found in 75% of patients. The 1-year and 2-year freedom from target lesion revascularization were 81% and 75%, respectively, and maximum walking distance showed improvement over the two years (pre; 234 m ± 211 m, 1-year; 402 m ± 241 m, 2-year; 428 m ± 231 m). The independent predictors for primary patency were pre-procedure ankle-brachial index, history of minor amputation, ostium lesion, and drug-coated balloon use. Angiographic analysis revealed that only lesion length and full cover stent were related to primary patency. Two-year freedom from target vessel revascularization was 75% in the Japanese transitional period of drug-eluting devices. Maximum walking distance was improved and well maintained for up to 2-year.

Peripheral artery disease (PAD) and atrial fibrillation (AF) are associated with major cardiovascular and cerebrovascular events (MACCE). However, outcomes stratified according to the preoperative symptoms of PAD in patients with AF have not been sufficiently investigated. This was a retrospective study of prospectively collected data pertaining to 2237 patients (1179 patients with intermittent claudication [IC] and 1058 patients with critical limb-threatening ischemia [CLTI]) who underwent endovascular therapy at 34 hospitals between August 2014 and August 2016. AF was present in 91 (7.7%) patients with IC and 150 (14.2%) patients with CLTI. In the CLTI group, patients with AF had a higher event rate of MACCE and all-cause death than those without AF (1-year rates of freedom from MACCE: 0.66 and 0.81 in patients with and without AF, respectively, p 0.001). In contrast, in the IC group, there was no statistically significant difference in the rates of MACCE between patients with and without AF. In the Cox multivariate analysis, AF was a significant predictor of MACCE in patients with CLTI but not in patients with IC, even after adjusting for covariates. The impact of AF on the outcome of patients with PAD was greater in those with CLTI. Further studies are needed to clarify the possible mechanisms underlying these differences.

BackgroundStatins bring favorable effects on the clinical prognosis of patients with atherosclerotic disease partly through their anti-inflammatory properties. However, this effect has not been fully verified in patients with peripheral arterial disease (PAD). We aimed to test whether statins exert different prognostic effects depending on the degrees of inflammation in patients with PAD.MethodsThis study was a sub-analysis of a multicenter prospective cohort of 2,321 consecutive patients with PAD who received endovascular therapy (EVT). After excluding patients without information on C-reactive protein (CRP) levels at the time of index EVT, 1,974 patients (1,021 statin users and 953 non-users) were ultimately analyzed. Enrolled patients were classified into four groups depending on CRP levels: low CRP (1.0 mg/dL). A composite of death, stroke, myocardial infarction, and major amputation as the primary endpoint was compared between statin users and non-users in each CRP category.ResultsOverall, statin users showed a significantly lower event rate than non-users (log-rank, pConclusionStatins may exert favorable prognostic effects in patients with PAD and highly elevated CRP levels but not in those with low to moderate CRP levels.Condensed abstractThis multicenter retrospective study compared the prognostic effects of statins among patients with peripheral arterial disease (PAD) presenting diverse baseline C-reactive protein (CRP) levels [low CRP (1.0 mg/dL)]. Multivariable analysis showed that statin use was independently associated with a lower rate of death, stroke, myocardial infarction, and major amputation only in the high-CRP category. This suggests that statins may have favorable prognostic effects in patients with PAD and active inflammation.

Implantations of leadless pacemakers in the septum lower the risk of cardiac perforation. However, the relationship between the implantation site and the success rate, complication rate, and pacemaker parameters are not well-investigated.Patients who underwent leadless pacemaker implantation with postprocedural computed tomography (CT) between September 2017 and November 2020 were analyzed. Septum was targeted with fluoroscopic guidance with contrast injection. We divided patients into two groups based on the implantation site confirmed by CT: septal and non-septal, which included the anterior/posterior edge of the septum and free wall. We compared the complication rates and pacemaker parameters between the two groups.A total of 67 patients underwent CT after the procedure; among them, 28 were included in the septal group and 39 were included in the non-septal group. The non-septal group had significantly higher R wave amplitudes (6.5 ± 3.3 vs. 9.7 ± 3.9 mV, p = .001), lower pacing threshold (1.0 ± 0.94 vs. 0.63 ± 0.45 V/0.24 ms, p = .02), and higher pacing impedance (615 ± 114.1 vs. 712.8 ± 181.3 ohms, p = .014) after the procedure compared to the septal group. Cardiac injuries were observed in four patients (one cardiac tamponade, one possible apical hematoma, two asymptomatic pericardial effusion), which were only observed in the non-septal group.Leadless pacemaker implantation may be technically challenging with substantial number of patients with non-septal implantation when assessed by CT. Septal implantation may have a lower risk of cardiac injury but may lead to inferior pacemaker parameters than non-septal implantation.

The incidence of lower extremity artery disease (LEAD) in patient receiving hemodialysis is remarkably higher than the general population. The treatment strategy and prognosis for LEAD patients differs depending on whether a patient has intermittent claudication (IC) or critical limb-threatening ischemia (CLTI). However, the distinction between the prognosis in HD-dependent patients with IC and CLTI has not been fully elucidated. This study is to determine whether indication of PAD has a distinct impact on major adverse cardiovascular and cerebrovascular events (MACCE) and limb events in patients receiving hemodialysis. The current study included 2321 prospectively enrolled patients from the Tokyo taMA peripheral vascular intervention research ComraDE registry (UMIN-CTR no. UMIN000015100) between September 2014 and December 2016. Out of the enrolled patients, 1644 were not receiving hemodialysis (non-HD patients) and 603 were receiving hemodialysis (HD patients). A composite of all-cause death, myocardial infarction, and stroke events defined as MACCE; while limb events were defined as a composite of unscheduled major amputation, unscheduled major lower limb surgery, acute limb ischemia, unscheduled endovascular treatment, and target lesion revascularization. Propensity score matching was applied among the non-HD and HD patients, in whole group, IC subgroup, and CLTI subgroup. Kaplan-Meier analysis was used for the analysis of outcomes for the whole group, IC subgroup, and the CLTI subgroup. CLTI accounted for 75.5% of the HD patients, whereas IC was 63.4% in the non-HD patients. The HD patients exhibited more frequent below-the-knee lesions than those in the non-HD patients in both IC (p = 0.01) and CLTI (p 0.001) subgroups. Overall, HD patients exhibited a significantly higher rate of MACCE at 24 months. This trend was similar for limb events in whole group and CLTI subgroup. In contrast, no significant differences in outcomes for limb events were found in IC subgroup. Although, prognosis after EVT in HD patients were significantly worse than non-HD patients, comparable outcome with non-HD patients was observed in the patients treated for IC. Clinical trial registration: This study was registered in the University Hospital Medical Information Network Clinical Trials Registry (UMIN-CTR No. UMIN000015100).

Background Catheter ablation for paroxysmal supraventricular tachycardia (PSVT) is an established treatment, but the effect of deep sedation on PSVT inducibility remains unclear. Aim We sought to examine PSVT inducibility and outcomes of catheter ablation under deep sedation using adaptive servo ventilation (ASV). Methods We retrospectively evaluated consecutive patients who underwent catheter ablation for PSVT under deep sedation (Propofol + Dexmedetomidine) with use of ASV. Anesthetic depth was controlled with BIS™ monitoring, and phenylephrine was administered to prevent anesthesia‐induced hypotension. PSVT induction was attempted in all patients using extrastimuli at baseline, and after isoproterenol (ISP) infusion when necessary. Results PSVT was successfully induced in 145 of 147 patients, although ISP infusion was required in the majority (89%). The PSVT was atrioventricular nodal reentrant tachycardia (AVNRT) in 77 (53%), atrioventricular reciprocating tachycardia (AVRT) in 51 (35%), and atrial tachycardia (AT) in 17 (12%). A higher ISP dose was required for AT compared to other PSVT (AVNRT: 0.06 (IQR 0.03‐0.06) vs AVRT: 0.03 (0.02‐0.06) vs AT: 0.06 (0.03‐0.12) mg/h, P = .013). More than half (51%) of the patients developed hypotension requiring phenylephrine; these patients were older. Acute success was obtained in 99% (patients with AVNRT had endpoints with single echo on ISP in 46%). Long‐term success rate was 136 of 144 (94%) (AVNRT 96%, AVRT 92%, and AT 93%). There were no complications related to deep sedation. Conclusions Deep sedation with use of ASV is a feasible anesthesia strategy for catheter ablation of PSVT with good long‐term outcome. PSVT remains inducible if ISP is used., Deep sedation with use of ASV is a feasible anesthesia strategy for catheter ablation of PSVT with good long‐term outcome. PSVT remains inducible if ISP is used.

Malnutrition measured by the geriatric nutritional risk index (GNRI) was reported to be associated with poor prognosis for patients with peripheral artery disease (PAD). However, the optimal cut-off value of preprocedural GNRI for critical limb ischemia (CLI) and intermittent claudication (IC) is unknown. We aimed to determine its optimal cut-off value for CLI or IC patients requiring endovascular revascularization.We explored data of 2246 patients (CLI: n = 1061, IC: n = 1185) registered in the Tokyo-taMA peripheral vascular intervention research COmraDE (TOMA-CODE) registry, which prospectively enrolled consecutive PAD patients who underwent endovascular revascularization in 34 hospitals in Japan from August 2014 to August 2016. The optimal cut-off values of GNRI were assessed by the survival classification and regression tree (CART) analyses, and the survival curve analyses for major adverse cardiovascular and limb events (MACLEs) were performed for these cut-off values.In addition to the first cut-off value of 96.2 in CLI and 85.6 in IC, the survival CART provided an additional cut-off value of 78.2 in CLI and 106.0 in IC for further risk stratification. The survival curve was significantly stratified by the GNRI-based malnutrition status in both CLI [high risk: 47.7% (51/107), moderate: 30.1% (118/392), and low: 10.2% (53/520), log-rank p 0.001] and IC [high risk: 14.3% (7/49), moderate: 4.5% (29/646), and low: 0.5% (2/407), log-rank p 0.001]. The multivariate Cox-proportional hazard analysis showed that a higher GNRI was significantly associated with a better outcome in both CLI [hazard ratio (HR) per 1-point increase: 0.97, 95% CI: 0.96-0.98, p 0.001] and IC (HR: 0.94, 95% CI: 0.91-0.97, p 0.001).Preprocedural nutritional status significantly stratified future events in patients with PAD. Given that the optimal cut-off value of GNRI in CLI was almost 10-points lower than that of IC, using a disease-specific cut-off value is important for risk stratification.

Background Venous bleeding complication is often observed after catheter ablation of atrial fibrillation (AF), but the risk factors remain unclear. Methods We retrospectively evaluated 570 consecutive patients who underwent catheter ablation of AF from April 2012 to March 2017. After the procedure, the sheaths were removed, and hemostasis was obtained by manual compression followed by application of rolled gauze with elastic bandage and continuous pressure to the puncture site. We evaluated the risk factors for venous bleeding complications defined as hemorrhage from the puncture site that needed recompression after removal of the elastic bandage and rolled gauze. Results After excluding 11 patients because of missing data, 559 patients (395 [70.7%] men, mean age: 65.6 ± 8.7 years) were included for analysis. Venous bleeding complication was observed in 213 patients (38.1%). In the multivariate logistic regression analysis, low body mass index (BMI; odds ratio [OR] 0.95, 95% CI 0.90‐1.00, P = .04), short compression time (OR 0.77, 95% CI 0.68‐0.88, P, We retrospectively evaluated 570 consecutive patients who underwent catheter ablation of atrial fibrillation. The risk factors for venous bleeding complications were analyzed. Low BMI, short compression time, and antiplatelet therapy were found to be the significant risk factors.

Depression is a chronic illness that affects mood, physical health, and overall vitality and quality of life. Depression has been associated with an increased risk of all-cause and cardiovascular mortality among patients with peripheral arterial disease (PAD). Therefore, this study aimed to compare the incidence of depression before and after endovascular treatment in patients with lower limb PAD. This is an important clinical issue considering the worldwide increase in PAD with the aging population and the known negative impact of depression on recovery. This was a retrospective sub-analysis of data from the Tokyo Peripheral Vascular Intervention Study using the TOMA-CODE registry. The presence and extent of depressive symptoms were evaluated using the patient health questionnaire (PHQ-9), with a depressive tendency score of ≥ 5. The PHQ-9 score was evaluated before endovascular treatment (EVT) and at 4 (± 1) weeks after EVT. The study population consisted of 87 patients who completed the PHQ-9 before EVT, with 76 completing the post-EVT PHQ-9. Of these 76, 19 had a pre-EVT score ≥ 5. Overall, there was no difference in the pre- and post-EVT scores (P = 0.091). There was no significant change in the 19 patients with a pre-EVT score ≥ 5 (mean 9.2 ± 4.4); however, there was a tendency to improve in the pre- to post-EVT score (mean, 6.9 ± 5.2; P = 0.059). Diabetes was a significant negative factor for pre- to post-EVT score improvement (P = 0.023). Overall, symptoms of depression showed the tendency to improve at 30 days post-EVT. However, diabetes was associated with lower improvement in symptoms.

Background. While the evaluation of burr speed was discussed regarding platelet aggregation, the association between platform speed and acute lumen gain of rotational atherectomy remains unknown. Methods. Through the evaluation of the potential of low-speed rotational atherectomy (LSRA) in in-vitro experiments, minimum lumen diameter (MLD) and minimum lumen area (MLA) after conventional high-speed rotational atherectomy (HSRA group) and those after LSRA following HSRA (LSRA+HSRA group) treated by 1.5 mm burrs were measured by optical frequency domain imaging (OFDI) in 30 consecutive human lesions. Results. The in-vitro experiments demonstrated that MLD and MLA after LSRA+HSRA were significantly larger (MLD: LSRA+HSRA=1.50 ±0.05 mm, HSRA= 1.43 ±0.05 mm, p=0.015; MLA: LSRA+HSRA= 1.90 ±0.17 mm2, HSRA= 1.71±0.11 mm2, and p= 0.037), requiring more crossing attempts (LSRA= 134 ±20 times, HSRA= 72 ±11 times, and p< 0.001). In human studies, there was no significance in reference vessel diameter and lesion length before the procedure between two groups. MLDs after LSRA+HSRA were significantly larger than those in HSRA (LSRA+HSRA= 1.22 ±0.16 mm, HSRA= 1.07 ±0.14 mm, and p= 0.0078), while MLAs after LSRA+HSRA tended to be larger (LSRA+HSRA= 1.79 ±0.51 mm2, HSRA= 1.55 ±0.47 mm2, and p= 0.19). There was no significance in the occurrence of in-hospital complication, including slow flow or no reflow, major dissection, and procedural myocardial infarction, between LSRA+HSRA and HSRA. Conclusions. LSRA can achieve larger lumen gain compared, whereas HSRA can pass calcified lesions easily. Combination of LSRA and HSRA is a safe and feasible strategy for severely calcified lesions in clinical practice.

Objectives The aim of this study was to explore the time course of survival advantage of TAVR over SAVR as function of the patients' risk and sex. Background Women have been reported to have better survival than men undergoing transcatheter aortic valve replacement (TAVR). However, scant data on the sex-based survival benefit of TAVR over surgical aortic valve replacement (SAVR) are available. Methods A systematic review of studies reporting clinical outcomes of men and women undergoing TAVR or SAVR was performed. Studies were divided into two groups according to average patient's risk score and the interplay of surgical risk and sex on outcomes were analyzed. Results Eight studies involving 6,596 women and 7,204 men patients were extracted. Unlike mens, women patients had survival advantage from TAVR over SAVR that became substantial at 1 year from index procedure and persisted at 2-year of follow-up. Moreover, this sex-based TAVR survival advantage was mainly observed in higher surgical risk patients. Men showed a significantly lower rate of residual paravalvular leak after SAVR. Conclusions Women patients had a selective mortality benefit from TAVR compared to SAVR. This sex-based TAVR benefit was mainly observed in high surgical risk patients beyond 1 year from procedure.

Objective The aim of this study was to assess the relationship between hypercholesterolemia (HC) and clinical events through a percutaneous coronary intervention (PCI) registry. HC is a well-known independent risk factor for long-term cardiovascular events after PCI. However, it has been reported to be associated with a lower risk of adverse events in patients with cancer or acute coronary syndrome. Methods We analyzed the relationship between HC and adverse events in patients treated with everolimus-eluting stents (EESs) through the Tokyo-MD PCI study (an all-comer, multicenter, observational registry). The propensity score method was applied to select two groups with similar baseline characteristics. Results The unadjusted population included 1,536 HC patients and 330 non-HC patients. Propensity score matching yielded 314 matched pairs. After baseline adjustment, the outcomes of HC patients were significantly better than those of the non-HC patients with respect to the primary endpoint, which was a combination of mortality from all causes, nonfatal myocardial infarction (MI), nonfatal neurological events, and major bleeding [hazard ratio (HR) 0.56, 95% confidence interval (CI) 0.39-0.81; p=0.002], and the secondary endpoints, which included a combination of mortality from all causes, nonfatal MI, and nonfatal neurological events (HR 0.59, 95% CI 0.39-0.88; p=0.01), and major bleeding (HR 0.42, 95% CI 0.20-0.88; p=0.02). A subgroup analysis showed age as an interaction factor for the primary endpoint (interaction p=0.035). Conclusion HC was associated with better outcomes in patients who underwent EES implantation, even after baseline adjustment.

To develop a scoring system that can adequately predict a successful guidewire crossing (S-GC) of below-the-knee (BTK) chronic total occlusions (CTOs) in angiographic evaluation.A retrospective, multicenter, nonrandomized study examined 448 consecutive BTK CTOs in 299 patients treated with endovascular therapy in seven Japanese medical centers from April 2012 to April 2020. The cohort was classified into two groups: an S-GC group and a failed guidewire crossing group.The final logistic regression model created by a backward stepwise multivariate logistic regression model included five variables: "No outflow of the target vessel," "CTO length ≥200 mm," "Reference vessel diameter 2.0 mm," "Calcification at the proximal entry point," and "Blunt type at entry point." Optimisms were adjusted using 1000 bootstrap samples with replacement and candidate's risk score models developed according to optimism-adjusted correlation coefficients of risk factors. Choosing the best model as the Japanese-BTK (J-BTK) CTO score by comparing the optimism-adjusted area under receiver-operating characteristic curves it was decided to assign one point to "Blunt type at the proximal entry point," one point to "Calcification at the proximal entry point," one point to "Reference vessel diameter 2.0 mm," one point to "CTO length ≥200 mm," and two points to "No outflow of the target vessel." This rule was then used to categorize BTK CTOs into four grades with varying probabilities of S-GC: grade A (J-BTK CTO score of 0 and 1), grade B (score of 2 and 3), grade C (score of 4 and 5), and grade D (score of 6). Rates of S-GC in each grade (grades A, B, C, and D) were 97.3%, 76.8%, 19.3%, and 0%, respectively. Lesions categorized as grade C or D have a lower chance of S-GC. Internal validation was performed using the Hosmer-Lemeshow test (P = .99).The J-BTK CTO score predicts the probability of an S-GC of BTK CTOs and stratifies the difficulty of endovascular therapy for BTK CTOs in angiographic evaluation.

Introduction Recent trials demonstrated favorable effects of statins on the clinical prognosis, partly through anti-inflammatory properties, in patients with coronary artery disease. However, this favorable effect has not been fully verified in patients with peripheral arterial disease (PAD). We hypothesized that statins exert different prognostic effects depending on the degrees of inflammation at the time of endovascular therapy (EVT). Methods This study is a subanalysis from the Toma-Code Registry that is a Japanese prospective cohort of 2,321 consecutive patients with PAD treated by endovascular therapy in hospitals from 2014 to 2016. After the exclusion of patients without information of C-reactive protein (CRP) at the time of index EVT, 2,039 patients including 1,039 statin users and 1,000 statin non-users were ultimately analyzed. The patient enrolled were divided into 4 categories depending on CRP level at the time of EVT; Low-CRP (1.0 mg/dL). A composite of death, stroke, myocardial infarction, and major amputation as the primary endpoint of this study was compared between statin users and non-users in each CRP category. Results The composite endpoint occurred in 255 patients during the observation period. Overall, statin users had a significantly lower event rate than non-users (Log-rank test: P Conclusion Statins may exert a favorable prognostic effect in PAD patients with highly elevated CRP, but not in those with low to moderate CRP level. Event free survival Funding Acknowledgement Type of funding source: None

BACKGROUND Stroke is a feared complication of transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). OBJECTIVES With this meta-analysis we aimed to evaluate the incidence of 30-day stroke with TAVR and SAVR focusing on its possible correlation with surgical risk. METHODS Major electronic databases were searched for studies published between January 2002 and October 2019 reporting the rates of 30-day stroke after TAVR and SAVR. Data were pooled using fixed- and random-effects models. The primary outcome of the study was stroke rate within 30-day from TAVR or SAVR. Results were stratified according to surgical risk score (high, intermediate and low). RESULTS A total of 23 studies were identified (TAVR: 14,589 patients; SAVR: 11,681 patients). Regardless of the model used, in the overall population TAVR was associated with a significant reduction in the risk of stroke compared with SAVR (fixed effect: OR 0.78, 95% CI 0.66-0.92, p = .003; random-effects: OR 0.80, 95% CI 0.64-1.00, p = .045). Rates of 30-day stroke after TAVR and SAVR were not significantly different in the high- (OR 1.01, 95% CI 0.44-1.98, p = .105) and intermediate-risk groups (OR 0.92, 95% CI 0.63-1.36, p = .319), while low-risk patients had a lower rate of 30-day stroke after TAVR than SAVR (OR 0.65, 95% CI 0.50-0.83, p

Transcatheter aortic valve replacement (TAVR) has been recognized as a well-established alternative to surgical aortic valve replacement (SAVR) for symptomatic aortic stenosis with high surgical risk. With this updated systematic review and meta-analysis, we evaluated TAVR vs. SAVR in low- and intermediate-risk subjects. Studies comparing TAVR and SAVR in low-risk patients (defined as STS ≤ 8% or EuroSCORE ≤ 20%) were identified with electronic searches. The principal endpoint was all-cause mortality at short term (

Being overweight has been identified as independent risk factors for coronary artery disease. However, overweight patients have been reported frequently to have better mortality outcomes, and there is little data showing they are at a disadvantage regarding secondary prevention of cardiovascular events. We analyzed the influence of being overweight (defined as body mass index > 25 kg/m2) on adverse events in patients who underwent everolimus-eluting stent (EES) implantation using a multicenter registry with a maximum follow-up of 3 years. Propensity score matching was done for adjusting baseline characteristics. We defined primary end points as major adverse cardiac and cerebrovascular events (MACCE: a composite of mortality from all causes, nonfatal myocardial infarction, and nonfatal stroke) and “MACCE excluding non-cardiac mortality”. Other adverse events were analyzed as key secondary end points. Out of 1918 patients, 450 pairs were obtained through propensity score matching. Overweight patients were superior to non-overweight patients regarding MACCE (event rates: 8.2 vs. 13.8% in overweight vs. non-overweight, respectively; log-rank p = 0.009) and “MACCE excluding non-cardiac mortality” (5.9 vs. 10.1%, p = 0.03). On secondary end points, not only did overweight patients have significantly fewer major bleeding events (2.2 vs. 4.8%, p = 0.02), but they also had smaller adverse event rates for almost all such events; the differences were not statistically significant. Overweight patients had better outcomes for MACCE, even on excluding non-cardiac mortalities. No result was supportive of an evident advantage to non-overweight EES-implanted patients in terms of secondary prevention of cardiovascular events.

BACKGROUND Previous implantation of a permanent pacemaker (PPM) is common among patients undergoing transcatheter aortic valve implantation (TAVI). Moreover, onset of conduction disturbances needing new PPM implantation after TAVI is frequent. The interplay of pre-existing and new-PPM on mortality after TAVI remains controversial. METHODS We performed a systematic review and study-level meta-analysis on the influence of PPM on mortality after TAVI. Patients were divided into 3 groups: pre-existing PPM, new-PPM (implantation within 30 days after TAVI) and no-PPM (without PPM up to 30 days after TAVI). Outcomes were compared using pairwise and network meta-analysis. RESULTS A total of 28 studies including 40,016 subjects were eligible. Patients of the no-PPM group had a lower mortality outcome compared to the rest of the study population (relative risk [RR] 0.76, 95% confidence interval [CI] 0.68-0.85, P

BACKGROUND Patients with small vessel disease (SVD) are at higher risk of adverse events after PCI compared to non-SVD patients. In this subset, the use of bioresorbable vascular scaffolds (BVS) has raised particular concern. OBJECTIVE We aimed to compare outcomes of Absorb BVS versus a 2nd-generation metallic everolimus-eluting stents (EES) in the SVD setting, by pooling patients from three large, prospective studies. METHODS Patients with SVD (reference vessel diameter ≤2.75 mm by QCA) and treated with Absorb BVS were identified in the Italian RAI and the MAASSTAD-Absorb registries. EES controls were identified in the COMPARE II Trial. We performed a propensity-score matching using several clinical and angiographic variables. Implantation technique was not object of matching, being device-specific. RESULTS Out of 4635 enrolled subjects, 1147 belonged to the SVD population. After matching, we obtained 337 pairs of patients. High clinical and angiographic complexity was found in both groups. Predilation and postdilation rates were significantly higher in BVS patients. No differences were found in terms of the device-oriented composite end-point at 1-year (HR = 1.08, 95%CI 0.5-2.3, P = .8) and 2-years (HR = 1.28, 95% CI: 0.68-2.43, P = .5). Notwithstanding, higher incidence of definite/probable stent thrombosis was observed in the BVS group at 1 year (HR 4.7, 95%CI 0.8-31.4, P = .08) and 2-years (HR = 8.34 95%CI 1.1-60.2, P = .04). CONCLUSION In this propensity-matched analysis pooling SVD patients of three large prospective studies, incidence of composite device-related events was comparable between BVS and EES up to 2 years follow-up. However, higher rates of stent thrombosis were found in the BVS group.

Crossover stenting of femoral bifurcation raises the concern of jeopardizing the deep femoral artery (DFA) entry, thereby increasing future risk of limb-threatening ischemia and amputation. This retrospective multicenter study compared clinical outcomes of crossover stenting and non-crossover stenting for ostial superficial femoral artery (SFA) lesions. We reviewed 125 limbs in 103 patients with successful stent implantation for ostial SFA lesions and allocated them to two groups, based on whether the stent crossed over the DFA orifice (CO, n = 54) or not (NC, n = 71). The decision of applying whether CO or NC was at the operators' discretion. Primary endpoints were incidences of major amputation and acute limb ischemia (ALI) at 24 months, and secondary endpoints were incidences of death, target lesion revascularization (TLR), composite of amputation or death, and major adverse limb events which was a composite of major amputation, ALI, TLR, or death at 24 months. Baseline characteristics were similar between the groups. Major amputation occurred only in the NC group, while ALI occurred only in the CO group. Kaplan-Meier estimation showed no significant differences in incidences of major amputation (NC: 3.0% vs. CO: 0.0%, p = 0.21), ALI, or any of the secondary endpoints. However, there was a trend towards higher incidence of ALI in the CO group (NC 0.0% vs. CO 3.9%, p = 0.11). Crossover stenting did not result in a significant difference in major amputation compared to non-crossover stenting within 24 months. However, it showed a trend towards higher incidence of ALI.

Diabetes mellitus (DM) and small vessel (SV) disease are two major predictors of adverse outcome in patients treated by percutaneous coronary intervention (PCI), even when last generation metallic drug-eluting stents (DES) are used. Bioresorbable scaffold (BRS) technology has been recently developed to overcome the disadvantages of metallic DES due to their permanent struts. Through the resorption process, BRS may provide a vascular restoration that appears very attractive especially when distal or diffusely diseased coronary segments are involved, as in diabetic patients and SV disease. However, robust evidence on the use of BRS in diabetics is lacking, and recent data have raised concerns on the use of BRS in SVs, particularly when reference vessel diameter (RVD) is

Background The values of n-3 and n-6 polyunsaturated fatty acids (PUFAs) like low eicosapentaenoic acid (EPA) /arachidonic acid (AA) ratio are known to be associated with cardiovascular events, however their relationship with coronary plaque vulnerability in acute myocardial infarction (AMI) is not revealed. Purpose We evaluated the relationship between n-3 and n-6 PUFAs and coronary plaque vulnerability assessed by optical coherence tomography (OCT) in AMI patients. Methods We investigated 79 AMI lesions (51 ST elevated myocardial infarction (STEMI) lesions and 28 non-STEMI lesions) that had undergone emergency percutaneous coronary intervention using OCT. Coronary plaque characteristics by OCT were compared with n-3 and n-6 PUFAs values which were measured on admission. Results Of all AMI lesions (n=79), 43 thin-cap fibroatheroma (TCFA) and 35 plaque rapture (PR) were detected by OCT. Lesions with TCFA had no significant relationship with n-3 and n-6 PUFAs values, whereas lesion with PR had significantly lower EPA values than those without (55.8±29.5 vs 74.3±37.1 μg/ml, p=0.018). Median low-density lipoprotein (LDL) cholesterol value was 117 (98–137) mg/dl and sub-analysis in patients who had lower LDL cholesterol values than median (n=39) revealed that EPA values were significantly lower in lesions with TCFA (56.3±30.9 vs 85.3±47.7 μg/ml, p=0.03). In STEMI patients, the values of EPA and EPA/AA ratio were significantly lower in lesions with TCFA (EPA: 55.5±22.8 vs 80.8±46.1 μg/ml, p=0.01; EPA/AA ratio: 0.34±0.16 vs 0.50±0.36, p=0.03). STEMI patients who had lower LDL cholesterol values Conclusion This study demonstrated that n-3 and n-6 PUFAs values were associated with coronary plaque vulnerability by OCT in AMI patients, especially in STEMI. These results suggest that n-3 and n-6 PUFAs may be residual risk markers of severe acute cardiovascular events in patients with low LDL cholesterol values.

Background Subjects with bicuspid aortic valve (BAV) have been excluded from transcatheter aortic valve replacement (TAVR) randomized trials. Methods With this meta-analysis of observational studies we first compared TAVR outcomes of BAV vs. tricuspid aortic valve (TAV) patients, stratifying the results by device generation. Then, we looked for differences between balloon-expandable (BE) and self-expandable (SE) bioprostheses in BAV patients. Primary outcome was 30-day mortality. Secondary outcomes were 30-day stroke, moderate-severe paravalvular leakage, new pacemaker implantation, vascular complications and 1-year mortality. Results Thirteen studies (11,032 patients, 7291 TAV and 3741 BAV) and seven studies (706 patients, 367 treated with BE, 339 with SE valve) met inclusion criteria. Thirty-day (OR = 1.13; 95% CI 0.88–1.46, p = 0.33) and 1-year mortality (OR = 1.02; 95% CI 0.77–1.37, p = 0.87) were similar between patients receiving TAVR for BAV or TAV. Subjects treated for BAV were at higher risk of conversion to conventional surgery (OR = 2.35; 95% CI 1.30–4.23, p = 0.005), implantation of a second valve (OR = 2.06; 95% CI 1.31–3.25; p = 0.002), moderate/severe paravalvular leakage (PVL) (OR = 1.67; 95% CI 1.29–2.17; p = 0.0001) and device failure (OR = 1.26; 95% CI 1.02–1.56; p = 0.04). Rates of adverse events decreased significantly with the use of new-generation devices, but outcome differences remained consistent. BAV patients treated with BE vs. SE valves had similar 30-day and 1-year mortality, stroke and moderate-severe PVL. Balloon-expandable valves were associated with lower rates of a second valve and new pacemaker implantation but carried higher risk of annular rupture. Conclusions BAV patients treated with TAVR had similar 30-day and 1-year mortality as well as stroke and new pacemaker implantation rates compared to TAV subjects, but carried higher risk of moderate/severe PVL, conversion to surgery and device failure. Event rates significantly decreased with the use of new-generation devices, but TAVR still showed better procedural results in TAV compared to BAV.

BACKGROUND Peripheral arterial disease (PAD) plays a decisive role in the preinterventional selection process of the optimal vascular access site in patients undergoing transcatheter aortic valve implantation (TAVI). However, the impact of PAD on mortality and vascular complications (VCs) in TAVI-treated patients remains unclear. Accordingly, we aimed to assess the outcomes of patients with and without PAD undergoing TAVI, by performing a meta-regression analysis. METHODS Studies published between January 2002 and March 2018 and reporting outcomes according to the presence of PAD in TAVI patients were identified. Outcome measures analyzed were short-, mid- and long-term mortality, and peri-procedural VC. The interaction between sheath size and PAD on outcomes was also assessed. RESULTS A total of 26 studies (68,581 TAVI patients, of whom 17,326 with preprocedural PAD) were included in the analysis. Patients with PAD had higher risk of mortality at short- (HR 1.36, 95% confidence interval [CI] 1.13-1.63, p = .0009), mid- (HR 1.18, 95% CI 1.08-1.30, p = .0005), and long-term (HR 1.36, 95% CI 1.24-1.48, p

Objective: Endovascular treatment (EVT) using a popliteal approach is effective for superficial femoral artery (SFA) chronic total occlusion (CTO); however, its effectiveness, safety, and consequent complications are unclear. Materials and Methods: We studied 324 consecutive EVTs (in 187 patients) performed at three centers between April 2008 and March 2013, and selected all EVTs that included SFA CTO regions. A total of 91 EVTs (in 65 patients) were included and divided into two groups; “with popliteal approach” (WPA) and “without popliteal approach” (WOPA). Results: Despite higher rates of hypertension (WPA, 88.9% vs. WOPA, 69.1%; p = 0.04) and CTO length >200 mm (55.6% vs. 28.3%, respectively; p

Background Long-term dual antiplatelet therapy (DAPT) for patients treated with coronary stents has been reported to be effective. However the effectiveness of long-term DAPT for everolimus-eluting stent (EES) implanted patients has been controversial. We assessed the major adverse cardiac and cerebral events (MACCE: a composite of death, myocardial infarction, or cerebral arterial disease) in patients free from MACCE during the first 2 years after EES implantation. Methods and results A total of 1918 patients who underwent successful percutaneous coronary intervention (PCI) with EES at 22 centers in Japan in 2010–2011 were enrolled, and 742 patients were free from MACCE for 2 years. We divided these MACCE-free patients into two groups: those who received DAPT for >2 years (Over-2-Year DAPT: n = 591), and those who received DAPT for ≤2 years (Under-2-Year DAPT: n = 151). We performed the landmark analysis that began at 2 years and evaluated at 3 years after PCI about the occurrence of MACCE, major bleeding, stent thrombosis, and restenosis between these groups, both with and without baseline adjustment by propensity score matching (n = 145 in both groups). Results Fifty MACCE cases were reported (Over-2-Year DAPT, 38; Under-2-Year DAPT, 12), with no significant differences between the 2 groups (log-rank test, p = 0.19). Even after baseline adjustment, there were no differences in MACCE occurrence (Over-2-Year DAPT, 8; Under-2-Year DAPT, 11, p = 0.19); 15 cases of major bleeding, 5 of restenosis, and 2 of stent thrombosis were observed after 2-years’ follow-up, with no statistical differences between the groups, although the event numbers were too low for comparison. Conclusion Continuing DAPT for >2 years did not prevent MACCE in patients free from MACCE during initial 2 years after EES implantation. Few events of major bleeding, stent thrombosis, and restenosis were observed, with no statistical differences.

Data on uninterrupted rivaroxaban taken preoperatively for radiofrequency catheter ablation (RFCA) of atrial fibrillation (AF) is limited. The aim was to evaluate safety and efficacy of rivaroxaban taken in the morning for AF ablation, especially with regard to asymptomatic cerebral emboli (ACE) and anticoagulation parameters. We prospectively evaluated 147 consecutive patients who underwent RFCA (mean age 66, 110 patients with paroxysmal AF), 76 of whom were on rivaroxaban, 71 on warfarin. The drugs were continued throughout the periprocedural period, including the morning of RFCA. Heparin infusion was maintained during RFCA to achieve an activated clotting time (ACT) of >300 s. There were no significant differences in basic patient characteristics and ablation procedure between the two groups. ACT during the procedure correlated significantly with prothrombin time and international normalized ratio in each group (correlation coefficient 0.799 in rivaroxaban, 0.705 in warfarin, p

Background Acute aortic dissection (AAD) is often missed on initial assessment. Purpose The aim of our study was to identify features associated with misdiagnosis of AAD. Methods and results We examined a total of 109 emergency room (ER) patients who were ultimately diagnosed with AAD. Misdiagnosis of AAD was defined as failure to diagnose AAD at the end of the initial assessment in the ER, and occurred in 17 patients (16%). The alternate diagnosis consisted of acute coronary syndrome (n = 10), other cardiovascular disease (n = 3), abdominal disease (n = 3), and cerebral infarction (n = 1). In the misdiagnosed patients, walk-in mode of admission to the ER (29% vs. 10%, p = 0.042) and anterior chest pain (71% vs. 41%, p = 0.025) were more frequent, and widened mediastinum (25% vs. 55%, p = 0.023) was less frequent than in diagnosed patients. The number of imaging studies performed per patient was also fewer in misdiagnosed patients than in diagnosed patients (0.82 ± 0.81 vs. 1.53 ± 0.52, p

Women have been reported to have better survival than men undergoing transcatheter aortic valve replacement (TAVR). However, scant data on the sex-based survival benefit of TAVR over surgical aortic valve replacement (SAVR) are available. We sought to explore the time course of survival advantage of

Background: Acute aortic dissection (AAD) often accompanies acute respiratory failure. The aim of this study was to clarify the relationship between the incidence of oxygenation impairment and the extent of distal type AAD. Methods and Results: A total of 49 patients with medically treated distal type AAD were retrospectively examined. AAD% was defined as the percentage of the volume of false lumen to that of aorta in the descending aorta. AAD% was measured by computed tomography. C-reactive protein (CRP) levels, white blood cell (WBC) counts, body temperature and arterial partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) ratio were measured serially. Oxygenation impairment was defined as a PaO2/FiO2 ratio ≤200. This occurred in 19 patients (39%). In patients with oxygenation impairment, AAD% (50.8±10.9% vs 28.0±11.9%, P

Back ground: Three-dimensional mapping systems such as the non-contact mapping system (EnSite) have been utilized for radiofrequency catheter ablation (RFCA) in cases with various kinds of arrhythmias. Methods: An EnSite system was utilized for RFCA in 12 patients with right-sided atrial tachycardia (AT). The patients were classified into two groups according to the focus of the AT in the right atrium (RA). The patients in whom the EnSite array was positioned near the focus of the AT were defined as group A, whereas those patients in whom the EnSite array was located less near the focus were defined as group B. RF energy was applied under the guidance of the mapping with the EnSite array. We investigated the relationship between the position of the EnSite array and the focus of the AT in terms of the mapping accuracy in both groups. Results: Even though the accuracy of the mapping of the breakout site and arrhythmia origin was comparable between groups A and B, the distance between the successful CA sites and the presumed AT focus according to the EnSite mapping was significantly shorter in group A than group B. Conclusions: As the location of the focus of the AT becomes closer to the proximal and distal ends of the ESB, the mapping accuracy deteriorates.

The association between the platform speed and acute lumen gain remains unknown. The purpose of this study is to evaluate the effect of additional lower-speed rotational atherectomy (RA) following conventional high-speed RA on acute lumen gain using sequential optical frequency domain imaging (OFDI

Diabetes mellitus (DM) is associated with increased risk of subsequent events after PCI. To evaluate the impact of Absorb bioresorbable vascular scaffold (BVS) in this setting, we aimed to compare the 1-year outcomes of Absorb BVS versus 2nd generation drug eluting stents (DES) by pooling diabetic

Valve heart disease occurs with equal frequency in men and women and increases in prevalence for both gender with advancing age (1). However, the Society of Thoracic Surgeons database and the Northern New England Cardiovascular Disease Study Group registry revealed that valve surgery patients were predominantly male (62%), and female sex was associated with greater operative mortality (2).

Background:The diagnostic value of unenhanced computed tomography (CT) for diagnosing acute aortic dissection (AAD) and ruptured thoracic aortic aneurysm (TAA) remains unclear.Methods and Results:We examined 219 consecutive patients who visited the emergency room with suspected acute aortic syndrome (AAS) because of chest or back pain and who underwent both unenhanced and contrast-enhanced 64-row multi-detector CT. The unenhanced CT findings were evaluated by the cardiologist on duty who was blind to the findings of contrast-enhanced CT. Diagnosis of AAS was confirmed in 103 patients (47%, 95 AAD and 8 ruptured TAA patients) based on evaluation of both unenhanced and contrast-enhanced CT images, which was used as the reference standard for validating the diagnostic value of the unenhanced CT findings. Sensitivity and specificity of the findings of a high-attenuation crescent, which represents hematoma in the aortic wall, were 61.2% and 99.1%, respectively. Sensitivity and specificity of linear high density in the aorta, which represents an intimal flap, were 59.2% and 96.6%, respectively. If unenhanced CT showed none of high-attenuation crescent, linear high density, internal displacement of intimal calcification, or TAA, the negative predictive value was 93.3%.Conclusions:Unenhanced CT is a good tool for ruling AAS in, but the false-negative rate of 6.7% is high for ruling AAS out because it has to be the minimum possible. (Circ J 2014; 78: 1928–1934)