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Endovascular treatment (EVT) is the main treatment for peripheral artery disease (PAD). Despite advances in device development, the restenosis rate remains high in patients with femoropopliteal lesions (FP). This study aimed to evaluate the effectiveness of exercise training in reducing the 1-year in-stent restenosis rate of bare metal nitinol stents for FPs. This prospective, randomized, open-label, multicenter study was conducted from January 2017 to March 2019. We randomized 44 patients who had claudication with de novo stenosis or occlusion of the FP into an intensive exercise group (n = 22) and non-intensive exercise group (n = 22). Non-intensive exercise was defined as walking for less than 30 min per session, fewer than three times a week. We assessed exercise tolerance using an activity meter at 1, 3, 6, and 12 months, and physiotherapists ensured maintenance of exercise quality every month. The primary endpoint was instant restenosis defined as a peak systolic velocity ratio > 2.5 on duplex ultrasound imaging. Kaplan–Meier analysis was used to evaluate the data. There were no significant differences in background characteristics between the groups. Six patients dropped out of the study within 1 year. In terms of the primary endpoint, intensive exercise significantly improved the patency rate of bare nitinol stents at 12 months. The 1-year freedom from in-stent restenosis rates were 81.3% in the intensive exercise group and 47.6% in the non-intensive exercise group (p = 0.043). No cases of stent fracture were observed in the intensive exercise group. Intensive exercise is safe and reduces in-stent restenosis in FP lesions after endovascular therapy for PAD. Clinical trial registration: University Hospital Medical Information Network Clinical Trials Registry (No. UMIN 000025259).

Although high thromboembolic risk was assumed in elderly patients with heart failure (HF) and atrial fibrillation (AF), inadequate control of prothrombin time/international normalized ratio was often observed in patients using vitamin K antagonists (VKAs). We hypothesized that patients treated with direct oral anticoagulants (DOAC) would have a better outcome than those treated with VKAs. The aim of this study was to compare the efficacies of DOACs and VKAs in elderly patients with HF and AF. We retrospectively analyzed data from a multicenter, prospective observational cohort study. A total of 1036 patients who were hospitalized for acute decompensated HF were enrolled. We assessed 329 patients aged > 65 years who had non-valvular AF and divided them into 2 groups according to the anticoagulant therapy they received. A subgroup analysis was performed using renal dysfunction based on estimated glomerular filtration rate (eGFR; mL/min/1.73 m2). The primary outcome was all-cause mortality, and the secondary outcomes were non-cardiovascular death or stroke. The median follow-up period was 730 days (range 334–1194 days). The primary outcome was observed in 84 patients; non-cardiovascular death, in 25 patients; and stroke, in 14 patients. The Kaplan–Meier analysis revealed that all-cause mortality was significantly lower in the DOAC group than in the VKA group (log-rank p = 0.033), whereas the incidence rates of non-cardiovascular death (log-rank p = 0.171) and stroke (log-rank p = 0.703) were not significantly different in the crude population. DOAC therapy was not associated with lower mortality in the crude population (log-rank p = 0.146) and in the eGFR ≥ 45 mL/min/1.73 m2 subgroup (log-rank p = 0.580). However, DOAC therapy was independently associated with lower mortality after adjustments for age, diabetes mellitus, and albumin level (hazard ratio, 0.55; 95% confidence interval, 0.30–0.99; p = 0.045) in the eGFR 2 subgroup. Compared with VKA therapy, DOAC therapy was associated with lower risk of all-cause mortality in the elderly HF patients with AF and renal dysfunction.

Purpose: Information on the relationship between frailty and the outcome of endovascular therapy (EVT) in elderly patients with lower extremity peripheral artery disease (PAD) is scarce. This study aimed to reveal the impact of frailty on the prognosis of super-elderly patients who underwent EVT. Materials and Methods: From August 2015 to August 2016, 335 consecutive patients who underwent EVT were enrolled in the I-PAD registry from 7 institutes in Nagano prefecture. Among them, we categorized 323 patients into 4 groups according to age and the presence or absence of frailty as follows: elderly with frailty (age ≥ 75, Clinical Frailty Scale [CFS] ≥ 5), elderly without frailty (age ≥ 75, CFS ≤ 4), young with frailty (age < 75, CFS ≥ 5), and young without frailty (age < 75, CFS ≤ 4); we analyzed them accordingly. The primary endpoints were major adverse cardiovascular and limb events (MACLE), defined as a composite of cardiovascular death, myocardial infarction, stroke, admission for heart failure, major amputation, and revascularization. The secondary endpoint was cardiovascular death. Results: The median follow-up period was 2.7 years. In the elderly with frailty, elderly without frailty, young with frailty, and young without frailty groups, the freedom rates from MACLE were 34.9%, 55.7%, 35.4%, and 63.0%, respectively (pConclusion: Frailty as defined by CFS might be a predictor of MACLE incidence in patients with PAD who underwent EVT. By considering treatment indications for patients with PAD by focusing on frailty rather than age, we may examine whether EVT policies are appropriate and manage patient and caregiver expectations for potential improvement in functional outcomes. Further studies are expected to investigate whether changes in frailty after EVT change prognosis.

An inverse correlation between body mass index and mortality in patients with peripheral artery disease (PAD) has been reported. However, little information is available regarding the impact of body composition on the clinical outcomes in patients with PAD. This study evaluated the relationships between the lean body mass index (LBMI), body fat % (BF%), and mortality and major amputation rate in patients with PAD. We evaluated 320 patients with PAD after endovascular treatment (EVT) enrolled from August 2015 to July 2016 and divided them into low and high LBMI and BF% groups based on their median values (17.47 kg/m2and 22.07%, respectively). We assessed 3-year mortality and major amputation for the following patient groups: Low LBMI/Low BF%, Low LBMI/High BF%, High LBMI/Low BF%, and High LBMI/High BF%. During the median 3.1-year follow-up period, 70 (21.9%) patients died and 9 (2.9%) patients experienced major amputation. The survival rate was lower in the Low LBMI than in the High LBMI group, and was not significantly different between the Low and High BF% groups. Survival rates were lowest in the Low LBMI/Low BF% group (57.5%) and highest in the High LBMI/High BF% group (94.4%). There were no significant differences in major amputation rate between the Low LBMI and High LBMI groups, and between the Low BF% and High BF% groups. The Low LBMI and Low BF% groups were associated with an increased risk of mortality after adjustment for age, sex, frailty and conventional risk factors [hazard ratio (HR): 4.02; 95% confidence interval (CI) 2.10–7.70;p p = 0.005, respectively], for age, sex, hemodialysis, and prior cerebral cardiovascular disease (HR: 3.63; 95% CI 1.93–6.82;p p = 0.009, respectively) and for age, sex, and laboratory date (HR: 3.97; 95% CI 1.88–8.37;p p = 0.026, respectively). In conclusion, Low LBMI and Low BF% were associated with poor prognosis in patients undergoing EVT for PAD, and mortality was the lowest in the High LBMI/High BF% group compared with other body composition groups.

BACKGROUND: Multisystem inflammatory syndrome in children (MIS-C) is a rare syndrome temporally related to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). MIS-C shares similarities with Kawasaki disease, but left ventricular dysfunction is more common in MIS-C.Methods and Results:This study reports the case of a 16-year-old Japanese male patient with MIS-C. Although the initial presentation was severe with circulatory and respiratory failure, the patient recovered completely. Endomyocardial biopsy showed active myocarditis with fibrosis. Immunoglobulin treatment was useful for recovery. CONCLUSIONS: This is the first reported case of MIS-C in Japan. Cardiologists should be aware of MIS-C, a new disease, occurring during the global SARS-CoV-2 pandemic.

The incidence of Dressler’s syndrome after myocardial infarction (MI) has decreased in the reperfusion therapy era. Although guidelines recommend high-dose aspirin for treatment based on evidence from the pre-percutaneous coronary intervention (pre-PCI) era, bleeding and thrombotic concerns occurred upon aspirin administration after coronary stenting. A 69-year-old man with recent MI was admitted to our hospital. The patient presented with chest pain 1 week before admission. Electrocardiography revealed newly detected atrial fibrillation with no ST segment change. Urgent coronary angiography demonstrated a left circumflex artery occlusion. He underwent PCI, and a sirolimus-eluting stent was deployed. Aspirin, prasugrel, and apixaban were administered. However, hospital discharge was delayed because he developed heart failure during hospitalization. Twenty-three days after admission, he developed a fever of >39 °C. Electrocardiography showed anterior ST segment elevation, and echocardiography revealed a 6-mm pericardial effusion. We diagnosed the patient with Dressler’s syndrome, and colchicine 0.5 mg/day + acetaminophen 2000 mg/day were administered. His condition clinically improved after treatment and he was discharged 32 days after admission. There was hesitation about administration of high-dose aspirin in a patient who has undergone recent coronary stenting. Combination therapy of colchicine and acetaminophen could be a treatment option for Dressler’s syndrome.

Transvenous lead extraction (TLE) is an established procedure for the management of cardiovascular implantable electronic devices. However, some difficulties and risks of complications still exist, especially in old and adhered leads. Evolution RL (Cook Medical, Bloomington, IN, USA) is a newly introduced device for TLE; however, no clinical results have been reported in Japan, and the results with older leads are unknown. We investigated the efficacy and safety of Evolution RL and its usefulness for old leads at two TLE centers in Japan.A total of 27 consecutive patients who underwent lead extraction using Evolution RL at Shinshu University Hospital and Tokyo Women's Medical University Hospital from September 2017 to December 2019 were retrospectively enrolled. We examined the backgrounds of the patients and leads and investigated the efficacy and safety of the procedures. We divided the leads into two groups according to the number of years of implantation (10 years) and compared the results.Among the 27 patients, 20 (74.1%) were men, and the median age was 62 (14-91) years. The total number of leads was 58, and the median implantation duration was 136 months (8-448). We achieved clinical success in all patients and complete procedural success in 24 patients (88.9%). In three patients, the broken tip of the lead remained in the heart. No major complications were noted. Of the 58 leads, there were 34 leads with more than 10 years of implantation, with significantly more Evolution RLs used (94.1% vs. 54.2%, p = 0.001) and significantly higher percentages of Evolution 11Fr, 13Fr, and steady sheaths used (79.4% vs. 33.3%, p = 0.001, 52.9% vs. 16.7%, p = 0.006, and 64.7% vs. 20.8%, p = 0.001, respectively).In two TLE centers in Japan, Evolution RL was shown to be safe and effective, even in leads older than 10 years.

Patients with critical limb ischemia (CLI) still have a high rate of lower limb amputation, which is associated with not only a decrease in quality of life but also poor life prognosis. Implantation of adipose-derived regenerative cells (ADRCs) has an angiogenic potential for patients with limb ischemia.We investigated safety, feasibility, and efficacy of therapeutic angiogenesis by cell transplantation (TACT) of ADRCs for those patients in multicenter clinical trial in Japan.The TACT-ADRC multicenter trial is a prospective, interventional, open-labeled study. Patients with CLI (Fontaine class III-IV) who have no other option for standard revascularization therapy were enrolled in this study. Thirty-four target ischemic limbs of 29 patients were received freshly isolated autologous ADRCs implantation.The overall survival rate at a post-operative period and at 6 months follow-up was 100% at any time points. As a primary endpoint for efficacy evaluation, 32 limbs out of 34 (94.1%) were free from major amputation for 6 months. Numerical rating scale (from 6 to 1) as QOL score, ulcer size (from 317 mmImplantation of autologous ADRCs could be safe and effective for the achievement of therapeutic angiogenesis in the multicenter settings, as a result in no major adverse event, optimal survival rate, and limb salvage for patients with no-conventional option against critical limb ischemia. TRN: jRCTb040190118; Date: Nov. 24th, 2015.

This study aimed to evaluate the early vascular response of ultra-thin strut bioresorbable polymer sirolimus-eluting stents (BP SES) using optical frequency domain imaging (OFDI). Ultra-thin strut BP SES have superior outcomes in terms of efficacy and safety endpoints when compared to other thin strut new-generation stents. However, the factors contributing to the superiority of BP SES over other thin strut new-generation stents are unclear. A total of 32 patients with multivessel disease requiring staged procedures at 1 month were enrolled from 3 cardiovascular institutions; of these, 31 were immediately assessed by OFDI (n = 31). All patients were assessed at 1 month after ultra-thin strut BP SES implantation. The primary endpoint was % of uncovered struts. A total of 1723 cross sections (17,014 struts) were analyzed at baseline and 1 month after percutaneous coronary intervention. The % uncovered struts at 1-month follow-up was 7.7% (4.0, 13.8). Furthermore, the covered strut % (88.4% and 80.4%, P = 0.013) and malapposition rate (2.7% and 4.3%, P = 0.012) were significantly different between the 60-μm and 80-μm stents. Ultra-thin strut BP SES implantation may feasibly achieve early vascular responses due to the ultra-thin struts. This may ultimately lead to lower stent thrombosis and target lesion failure rates. Clinical trial registration University Hospital Medical Information Network Clinical Trials Registry (No. UMIN000033406).

Little is known about the impact of changes in body mass index (BMI) after the percutaneous coronary intervention (PCI) on long-term outcomes in patients with coronary artery disease (CAD). Therefore, this study aimed to clarify this issue. We investigated data on CAD obtained from the SHINANO Registry, a prospective, observational, multicenter cohort study, from 2012 to 2013 in Nagano, Japan. One year after PCI, the enrolled patients were divided into the following three groups based on changes in BMI by tertiles: reduced, maintained, and elevated BMI. The associations among the groups and the 4-year outcomes [major adverse cardiac events (MACEs), all-cause death, Q-wave myocardial infarction, and stroke] were examined. Five hundred seventy-two patients were divided into the reduced, maintained, and elevated BMI groups. Over the 4-year follow-up period, the cumulative incidence of MACEs was 10.5% (60 cases). In the Kaplan–Meier analysis, the incidence rates of MACE were significantly higher in the reduced BMI group than in the maintained and elevated BMI groups [17.7% versus (vs.) 7.3% vs. 9.0%, p = 0.004]. Multivariable cox regression analysis showed that the reduced group showed increased risks of MACEs (hazard ratio 2.15; 95% confidence interval 1.29–3.57; p = 0.003). The long-term clinical outcomes of patients with CAD who underwent PCI were affected by the reduction in BMI after PCI. Furthermore, the elevation of BMI after PCI was not a poor prognostic factor.

We investigated the prognostic effects of hyperuricemia and high or low body mass index (BMI) in peripheral artery disease (PAD) after endovascular therapy (EVT). Between July 2015–2016, 357 consecutive patients with PAD who underwent EVT were enrolled. Patients were divided into 2 groups: BMI < 25 kg/m2 (low BMI) and ≥ 25 kg/m2 (high BMI); they were also divided into 2 more groups based on the presence/absence of hyperuricemia. The primary and secondary endpoints were major adverse cardiovascular and limb events (MACLE), and all-cause death at 3 years post-EVT. Patients with hyperuricemia had significantly lower freedom from MACLE than patients without hyperuricemia at 3 years (57.0 vs 71.9%, p = .0068). The overall survival of patients with hyperuricemia was significantly lower than that of patients without hyperuricemia (63.9 vs 81.7%, p = .0012). Patients with hyperuricemia who had low BMI experienced significantly lower freedom from MACLE than those without hyperuricemia who had low BMI (48.2 vs 69.9%, p = .002). The overall survival of patients with hyperuricemia who had low BMI was significantly lower than that of patients without hyperuricemia who had low BMI (55.2 vs 77.1%, p = .003). Patients with hyperuricemia had significantly more MACLE and a lower survival at 3 years than patients without hyperuricemia, even if they had a low BMI.

Acute lymphocytic myocarditis in pregnancy is rare, with no established management guidelines to date. A 40-year-old woman at 34 weeks of gestation complained of shortness of breath upon exertion. An electrocardiogram revealed broad ST elevation, and echocardiography showed diffuse impairment of left ventricular contractility. The patient was immediately transferred to our hospital for suspected takotsubo cardiomyopathy. We considered myocarditis based on the patient’s prior cold-like symptoms and additional examination. Myocardial biopsy revealed lymphocyte infiltration, which confirmed acute lymphocytic myocarditis. Although there were no signs of heart failure or conduction disturbance under catecholamine, her hemodynamics were weak. Emergency cesarean section was performed because of possible hemodynamic failure during the remaining course of pregnancy. Both the mother and baby were discharged without any subsequent events. If acute myocarditis is suspected during pregnancy, prompt myocardial biopsy is crucial for timely pathological diagnosis and treatment decisions. Clinicians should consider premature delivery prior to a possible failure in maternal hemodynamics.

Heart failure with preserved ejection fraction (HFpEF) has currently become a major concern in the aging society owing to its substantial and growing prevalence. Recent investigations regarding sacubitril/valsartan have suggested that there is a gender difference in the efficacy of the medication in HFpEF cohort. However, information of gender difference in clinical profiles, examination, and prognosis have not been well investigated. The present study aimed to evaluate the differences in baseline characteristics and outcomes between women and men in a Japanese HFpEF cohort. We analyzed the data from our prospective, observational, and multicenter cohort study. Overall, 1036 consecutive patients hospitalized for acute decompensated heart failure were enrolled. We defined patients with an ejection fraction (EF) of ≥ 50% as HFpEF. Patients with severe valvular disease were excluded; the remaining 379 patients (women: n = 201, men: n = 178) were assessed. Women were older than men [median: 85 (79–89) years vs. 83 (75–87) years, p = 0.013]. Diabetes mellitus, hyperuricemia, and coronary artery disease were more prevalent in men than in women (34.8% vs. 23.9%, p = 0.019, 23.6% vs. 11.4%, p = 0.002, and 23.0% vs. 11.9%, p = 0.005, respectively). EF was not significantly different between women and men. The cumulative incidence of cardiovascular death or hospitalization for congestive heart failure (CHF) was significantly lower in women than in men (log-rank p = 0.040). Women with HFpEF were older and less often exhibited an ischemic etiology; further, they were associated with a lower risk for cardiovascular death or hospitalization for CHF compared with men in the Japanese population.

Laser speckle flowgraphy (LSFG) is a new device that can measure skin blood flow and capture the movement of erythrocytes. However, there are a few reports on the use of LSFG to estimate skin blood flow, especially in the lower extremities. We aimed to compare plantar skin blood flow between patients with and without peripheral arterial disease (PAD) to discern the extent to which LSFG could accurately predict PAD. We prospectively measured the plantar skin blood flow in 28 patients with PAD and 37 participants without PAD at two hospitals from 2017 to 2021, using the ankle-brachial index (ABI) and LSFG. We partitioned the plantar into 12 parts: digits 1-5, medial metatarsal, middle metatarsal, lateral metatarsal, medial arch, middle arch, lateral arch, and heel, and compared the difference between the two groups and the area under the curve (AUC) of each point. Statistical analyses were performed to determine the sensitivity, specificity, false-positive rate, and false-negative rate at high accuracy points of AUC and ABI. There was a significant difference among the 12 points between the two groups, and the ratio using toe 1 and toe 5 was highly accurate. The ratio using toe 1 indicated higher sensitivity (89 vs. 82%), higher false-positive rate (22 vs. 4%), lower specificity (81 vs. 97%), and an equivalent false-negative rate (9 vs. 12%) to that of the ABI. These findings could facilitate the use of LSFG to estimate the skin blood flow condition in the plantar skin. Our results indicate that measuring toe 1 using LSFG could be used to somewhat assess PAD.

Significant improvements in percutaneous coronary intervention (PCI) technology have enabled cardiovascular procedures to be performed without onsite cardiac surgery facilities. However, little is known about the association between onsite cardiac surgical support and long-term outcomes of PCI, particularly among emergent and complex cases. We investigated whether the presence or absence of cardiovascular surgery affects the long-term prognosis after PCI, emergent and complex elective cases. The SHINANO 5-year registry, a prospective, observational, and multicenter cohort study registry in Nagano, Japan, consecutively included 1665 patients who underwent PCI between August 2012 and July 2013. The procedures were performed at 11 hospitals with onsite cardiac surgery facilities [onsite surgery (+) group; n = 1257] and 8 hospitals without onsite cardiac surgery facilities [onsite surgery (−) group; n = 408]. The primary endpoint was all-cause mortality and the secondary endpoint was major adverse cardiac and cerebrovascular events [MACCE: all-cause death, Q-wave myocardial infarction, non-fatal stroke, and target lesion revascularization]. The onsite surgery group (+) had a lower rate of emergent PCI and ST-segment elevation myocardial infarction (40.8% vs. 51.7%, p p p p p = 0.421) and MACCE incidence (31.6% vs. 28.9%, p = 0.354) between the groups. Also, there were no differences in the mortality rate and incidence of MACCE among emergent cases of ST-segment elevation myocardial infarction and complex elective cases who underwent PCI. Long-term outcomes of PCI appear to be comparable between institutions with and without onsite cardiac surgical facilities.

Inferior vena cava (IVC) filters are often used to treat deep vein thrombosis. IVC filters may become difficult to extract because of adhesion around the device, and those permanently left inside the patient may cause injurious complications. We describe a novel IVC filter extraction technique using pacemaker lead extraction tools. A 26-year-old woman, diagnosed with deep vein thrombosis by computed tomography, received an IVC filter (Gunther Tulip, Cook Medical, Bloomington, IN, USA) implantation for prevention of pulmonary thromboembolism. Eleven weeks later, extraction of the IVC filter by a manual method and snaring technique was unsuccessful because of adhesion to the blood vessel wall. The patient was referred to our hospital for filter removal using pacemaker lead extraction tools. Extraction was performed in an operation room under general anesthesia in the presence of a cardiovascular surgeon, to manage inadvertent perforation. Part of the adhered tissue around the four limbs of the filter was dissected using a 12 Fr laser sheath; protruding anchors were carefully dissected with a telescoping mechanical sheath using a counter-traction technique. Her postoperative course was uneventful, and she was discharged without complications. A sophisticated removal procedure with pacemaker lead extraction tools can be used to remove problematic IVC filters.

The aim of this study was to investigate the prognostic significance of high-sensitivity troponin T (hs-TnT) in patients with heart failure (HF) with preserved ejection fraction (HFpEF). We enrolled consecutive patients admitted to Shinshu University Hospital for HF treatment between July 2014 and March 2017 and stratified them into HF with reduced ejection fraction and HFpEF groups (left ventricular ejection fraction

Background Despite the best efforts of pediatricians, healthcare for adult patients with congenital heart disease (ACHD) has proven challenging because of the increased numbers. This study presents the process of establishing an ACHD care system as a collaborative effort between Shinshu University Hospital and Nagano Children's Hospital. Methods and Results: Establishing an outpatient clinic for transition, a cooperation agreement for in-patient care between the 2 hospitals, and quality management of diagnostic imaging and educational meetings for adult cardiologists were the 3 major challenges. Of the 99 patients who visited the transition clinic in the children's hospital between May 2014 and December 2016, 3 returned to the pediatrician's clinic. Between June 2013 and December 2017, 273 patients visited the ACHD center in Shinshu University Hospital. Until December 2017, mortality and fatal arrhythmia were noted in 3 and 2 cases, respectively. Catheter ablation for arrhythmia was performed in 12 cases, and 4 cases of pregnancy with moderate/severe ACHD or estimated as high risk were managed with healthy livebirths. Surgical interventions for moderate/severe ACHD were performed in collaboration with the children's hospital or Sakakibara Heart Institute. Conclusions Patients were successfully transferred to adult cardiology departments. Surgical and nonsurgical interventions for ACHD were provided. Collaboration between adult and pediatric cardiologists assists in the establishment of healthcare systems for ACHD.

A 29-year-old woman was admitted to our hospital due to diagnosis of pregnancy at 5 weeks and a day. She underwent valve replacement with mechanical heart valve (MHV: SJM valve) for congenital mitral valve regurgitation, when 11 years old. Warfarin 4 mg was used for anticoagulation. After admission, warfarin was replaced by unfractionated heparin (UFH). She developed exertional dyspnea at 8 weeks of pregnancy. Echocardiogram and fluoroscopy showed an immobile leaflet in the closed position. She was diagnosed with mechanical valve thrombosis. Cardiac surgery or thrombolytic therapy (TT) were treatment options. TT is not established, but is reported to be safer than cardiac surgery. Recently, low-dose, slow infusion of recombinant tissue plasminogen activator (rt-PA) therapy showed acceptable results. About 2.5 h after an intravenous injection of rt-PA, diastolic rumble improved to the normal range of leaflet. Thereafter, warfarin was restarted and there was no recurrence of symptoms and no abortion. She was readmitted for the scheduled Caesarean section (CS) at 32 weeks of pregnancy, and warfarin was replaced with UFH. At 34 weeks of pregnancy, a baby was delivered by CS. She suffered hemostasis after surgery under the anticoagulation. Postoperative day 31, both mother and a child were healthy and left the hospital.

This study aimed to evaluate the association between abdominal fat distribution (AFD) and coronary artery disease (CAD) complexities using the computed tomography (CT)-derived SYNTAX score (CT-SXscore). Coronary computed tomographic angiography (CCTA) was performed in patients with suspected CAD. Plain abdominal CT was performed to measure visceral adipose tissue (VAT) and subcutaneous adipose tissue (SAT) areas. To assess AFD, VAT/SAT (V/S) ratios were calculated. The CT-SXscore was calculated in patients with significant stenoses assessed by CCTA. Of 942 enrolled patients, 310 (32.9%) had 1 or more significant stenoses. The CT-SXscore showed a positive correlation with the V/S ratio (r = 0.33, p < 0.001). In the multivariate regression analysis, the V/S ratio was the only independent predictor for CAD severity based on the CT-SXscore (β = 0.25; t = 4.14; p < 0.001), even though the absolute SAT and VAT areas showed no relationship to the CT-SXscore. Regarding the 4 CAD-patient groups divided according to their median VAT and SAT areas, the CT-SXscore was significantly higher for the high VAT/low SAT group than for any other group (19.6 ± 11.5 vs 13.3 ± 9.6 in the low VAT/low SAT, 10.1 ± 8.5 in the low VAT/high SAT, and 12.2 ± 8.7 in the high VAT/high SAT groups; p < 0.001 for all). In conclusion, it was found that the V/S ratio is a useful index for predicting CAD severity and that AFD may be a more important risk factor for CAD than the absolute amount of each abdominal fat.

Chronic kidney disease is a prognostic factor for cardiovascular disease. Worsening renal function (WRF), specifically, is an important predictor of mortality in patients with acute myocardial infarction undergoing primary percutaneous coronary intervention (PCI). We evaluate the prognostic impact of mid-term WRF after PCI on future cardiovascular events. We examined the renal function data of 1086 patients in the first year after PCI using the SHINANO 5-year registry. Patients were divided into two groups, mid-term WRF and non-mid-term WRF, and primary outcomes were major adverse cardiovascular events (MACE) and death. Mid-term WRF was defined as an increase in creatinine (≥ 0.3 mg/dL) in the first year after PCI. Mid-term WRF was found in 101 patients (9.3%), and compared to non-mid-term WRF, it significantly increased the incidence of MACE (p p p = 0.001). Furthermore, mid-term WRF patients had higher incidence of future heart failure (p p = 0.01). Patients with both mid-term WRF and chronic kidney disease had increased MACE compared to patients with either condition alone (p p p

Transvenous lead extraction (TLE) for cardiac implantable electric device (CIED) infection is becoming increasingly common, but is believed to be particularly risky in elderly patients. This study aimed to clarify the safety and effectiveness of TLE in the elderly, evaluating the use of both non-laser and laser extraction tools. We retrospectively analyzed the characteristics, device type, indications, procedures, and clinical results in younger (YG; age: 15–79 years; n = 48) and elderly groups (EG; age: ≥ 80 years; n = 27) of patients who underwent percutaneous TLE between April 2014 and December 2019 at our hospital. The average age was 68 and 88 years in the YG and EG, respectively. Indications for TLE were infection in 33 (68.8%) patients and other in 15 (30.6%) patients in the YG, and infection in all 27 (100%) EG patients. Bloodstream infection was detected in 9 and 4 patients in the YG and EG, respectively, with methicillin-resistant Staphylococcus epidermidis being the most common causative pathogen. All TLE procedures were performed under general anesthesia in an operating room with cardiovascular surgeon backup. An excimer laser sheath (76 leads), a laser followed by a mechanical sheath (45 leads), Evolution RL® (17 leads), a mechanical sheath (9 leads), and manual traction (one lead) were employed to extract a total of 148 leads (98 and 50 in the YG and EG, respectively). A mechanical sheath or Evolution RL® was more frequently used in the YG. The respective average implantation durations in the YG and EG were 5.3 and 5.0 years, respectively, which were comparable (p = 0.46). Procedural success rates were identical between the YG and EG (99% vs. 100%, respectively). There was only one procedure-related complication in the entire cohort (cardiac tamponade in a YG patient). Taken together, the success rates of TLE were high in the EG, with no complications, with extraction being the indication for infection in all EG patients. Percutaneous TLE was safe and effective in elderly patients using both non-laser and laser techniques.

BackgroundThe composite Model for End-Stage Liver Disease Excluding International Normalized Ratio Score (MELD-XI) is a novel tool to evaluate cardio-renal and cardio-hepatic interactions in patients with advanced heart failure (HF). However, its prognostic ability remains unclear in elderly HF patients.Methods and resultsFrom July 2014 to July 2018, patients hospitalized for HF were prospectively recruited at 16 centers. Clinical features, laboratory findings, and echocardiography results were assessed prior to discharge. Cardiovascular (CV) death and HF re-hospitalization were recorded. Of the 676 patients enrolled, 264 (39.1%) experienced CV events throughout a 1-year median follow-up period. Patients with high MELD-XI were predominantly male and had a higher prevalence of NYHA III/IV, history of HF admission, hyperuricemia, ventricular tachycardia, anemia, and ischemic heart disease. In Kaplan-Meyer analysis, patients with higher MELD-XI (≥11) scores showed a worse prognosis than did those with lower (ConclusionsCardio-renal and cardio-hepatic interactions predicted CV events in aged HF patients.

We developed a prediction model of long-term risk after percutaneous coronary intervention (PCI) for coronary chronic total occlusion (CTO) based on pre-procedural clinical information. A total of 4,139 eligible patients, who underwent CTO-PCI at 52 Japanese centers were included. Specifically, 1,909 patients with 1-year data were randomly divided into the derivation (n = 1,273) and validation (n = 636) groups. Major adverse cardiac and cardiovascular event (MACCE) was the primary endpoint, including death, stroke, revascularization, and non-fatal myocardial infarction. We assessed the performance of our model using the area under the receiver operating characteristic curve (AUC) and assigned a simplified point-scoring system. One-hundred-thirty-eight (10.8%) patients experienced MACCE in the derivation cohort with hemodialysis (HD: odds ratio [OR] = 2.55), left ventricular ejection fractions (LVEF)

Objectives The NIPPON (Nobori Dual Antiplatelet Therapy as Appropriate Duration) study was a multicenter randomized investigation of the noninferiority of short-term versus long-term dual antiplatelet therapy (DAPT) in patients with implantation of the Nobori drug-eluting stent (DES) (Terumo, Tokyo, Japan), which has a biodegradable abluminal coating. Background The optimum duration of DAPT for patients with a biodegradable polymer-coated DES is unclear. Methods The subjects were 3,773 patients with stable or acute coronary syndromes undergoing Nobori stent implantation. They were randomized 1:1 to receive DAPT for 6 or 18 months. The primary endpoint was net adverse clinical and cerebrovascular events (NACCE) (all-cause mortality, myocardial infarction, stroke, and major bleeding) from 6 to 18 months after stenting. Intention-to-treat analysis was performed in 3,307 patients who were followed for at least 6 months. Results NACCE occurred in 34 patients (2.1%) receiving short-term DAPT and 24 patients (1.5%) receiving long-term DAPT (difference 0.6%, 95% confidence interval [CI]: 1.5 to 0.3). Because the lower limit of the 95% CI was inside the specified margin of −2%, noninferiority of short-term DAPT was confirmed. Mortality was 1.0% with short-term DAPT versus 0.4% with long-term DAPT, whereas myocardial infarction was 0.2% versus 0.1%, and major bleeding was 0.7% versus 0.7%, respectively. The estimated probability of NACCE was lower in the long-term DAPT group (hazard ratio: 1.44, 95% CI: 0.86 to 2.43). Conclusions Six months of DAPT was not inferior to 18 months of DAPT following implantation of a DES with a biodegradable abluminal coating. However, this result needs to be interpreted with caution given the open-label design and wide noninferiority margin of the present study. (Nobori Dual Antiplatelet Therapy as Appropriate Duration [NIPPON]; NCT01514227)

Diastolic wall strain (DWS) is based on the linear elastic theory, according to which decreased wall thinning during diastole reflects reduced left ventricular compliance and thus increased diastolic stiffness. Increased diastolic stiffness as assessed by DWS is associated with a worse prognosis in patients who have heart failure (HF) with preserved ejection fraction. However, there are no data about the prognostic value of DWS derived by M-mode echocardiography in patients at risk for HF. We retrospectively enrolled 1829 consecutive patients without prior HF who were hospitalized for cardiovascular (CV) diseases in our hospital between 2005 and 2012. Patients were divided into two groups stratified by DWS (median value 0.34). The study endpoint was the composite of major adverse cardiovascular events (MACE), including all-cause death, myocardial infarction, stroke, and hospitalization for HF. Over a 4.2-year median follow-up, adverse events were observed in 322 patients (17.6%). In Kaplan-Meier analysis, patients with low DWS (≤ 0.34, n = 915) showed worse prognoses than those with high DWS (> 0.34, n = 914) (MACE incidence 39.4% versus 31.9%, P = 0.011). In multivariate Cox proportional hazards analysis after the adjustment for age, sex, and echocardiographic parameters, low DWS (≤ 0.34) was significantly associated with the incidence of MACE (hazard ratio: 1.26, 95% confidence interval: 1.01-1.59; P = 0 .045). In patients without prior HF, DWS is an independent predictor of MACE. Simple assessment of DWS might improve risk stratification for CV events in those patients.

Objective A low ankle-brachial index (ABI) is a known predictor for future cardiovascular events and mortality in patients with chronic kidney disease (CKD). While most prior studies have defined CKD as an estimated glomerular filtration rate (eGFR) 0.9 (90.8%). The primary outcome measured was the cumulative incidence of major adverse cardiovascular events (MACE; cardiovascular death, myocardial infarction, and stroke). Results Over a mean follow-up of 5.0 years, 101 MACE occurred. The incidence of MACE was significantly higher in patients with low ABI than in those with ABI >0.9 (30.2% vs. 14.4%, log rank p

Background: We evaluated the 1-year outcomes of percutaneous coronary intervention (PCI) for elderly patients (aged ≥ 80 years) in the second-generation drug-eluting stent (DES) era. Methods and Results: Between August 2012 and July 2013, 1923 consecutive patients (mean age, 71 ± 11 years; ≥80 years, 23%; men, 77%) who underwent 2250 elective/urgent PCI procedures were enrolled in the Shinshu Prospective Multicenter Analysis for Elderly Patients with Coronary Artery Disease Undergoing Percutaneous Coronary Intervention registry. The primary end point was major adverse cardiovascular events (MACEs; cardiovascular death, myocardial infarction, and stroke) at 1 year. The 1-year incidence of MACEs, cardiac death, and stroke was significantly higher in elderly patients than in nonelderly patients (12.4% vs 5.3%, P < .0001; 7.8% vs 2.2%, P < .0001; and 2.8% vs 1.3%, P = .033, respectively). However, no significant difference in elective PCI procedures was detected. In elderly patients, the incidence of cardiac death and target lesion revascularization was significantly lower for DES than for non-DES (2.7% vs 10.5%, P = .0001 and 4.1% vs 8.6%, P = .029, respectively). Conclusion: Although elderly patients had a significantly poorer prognosis than younger patients, the adverse events rate was comparable in those patients who underwent elective PCI in the second-generation DES era.

Background We sometimes experience regression of left ventricular hypertrabeculation (LVHT), which is compatible with the diagnosis of LV non-compaction cardiomyopathy (LVNC) in adult patients. However, little is known about the association between LVHT regression and LV systolic function in adult patients. Methods We prospectively examined 23 consecutive adult patients who fulfilled the echocardiographic criteria for LVNC. LV reverse remodeling (RR) was defined as an absolute increase in LV ejection fraction of >10% at 6 months follow-up. LVHT area was calculated by subtraction from the outer edge to the inner edge of the LVHT at end-systole. Results The mean follow-up period was 61 months. LVRR was observed in 9 patients (39%). The changes in the mean LVHT area showed significant correlation with the changes in LV ejection fraction (r = −0.78, p Conclusions Regression of LVHT is associated with improvement in LV systolic function. LVRR might be associated with a favorable prognosis in patients with LVHT.

Background Although cardiac rehabilitation (CR) can improve exercise capacity and quality of life in patients with chronic heart failure (HF), the long-term prognostic influence of inpatient CR on patients with acute decompensated HF (ADHF) is not well established. We examined the impact of inpatient CR on disability and prognosis in patients with ADHF. Methods A total of 171 patients admitted for ADHF underwent CR that included resistance training and aerobic exercise. Patient disability was evaluated using Barthel Index (BI) scores at pre- (BIpre) and post- (BIpost) rehabilitation. All-cause mortality was retrospectively recorded after discharge. Results In the study cohort (median age: 76 years), 46 patients experienced all-cause mortality during a median of 478 days of follow-up. Impaired BIpost (i.e., BI 15) among patients with impaired baseline BI. BIpost was an independent predictor of all-cause mortality after adjusting for age, sex, eGFR, BNP, hemoglobin, albumin, and left ventricular ejection fraction. Conclusions Inpatient CR led to improvements in disabilities among patients with ADHF. Baseline disabilities were associated with a poor prognosis. Greater improvements in BI to inpatient CR were significantly related to better outcomes in patients with impaired baseline BI. CR should be indicated for patients with ADHF.

The ankle brachial index (ABI) is regarded as a predictor of future cardiovascular events. However, the relationship between ABI and incident heart failure (HF) in patients without previous HF is poorly understood. This study aimed to assess the prognostic value of ABI for incident HF in patients without previous HF. The IMPACT–ABI study was a retrospective, single-center, cohort study that enrolled and measured ABI in 3131 patients hospitalized for cardiovascular disease between January 2005 and December 2012. From this cohort, 307 patients were excluded because of previous HF and high (>1.4) ABI. The remaining 2824 patients were stratified into three groups: low ABI (≤0.9), borderline ABI (0.91–0.99), and normal ABI (1.0–1.4). The primary endpoint was hospitalization for HF. Over a mean 4.8-year follow-up, 105 cases of HF occurred. The cumulative incidence of HF was significantly higher in patients with low and borderline ABIs than in those with normal ABI (19.3 vs. 21.0 vs. 10.4 %, log rank P

The admission shock index (SI) enables prediction of short-term prognosis. This study investigated the prognostic implications of admission SI for predicting long-term prognoses for acute myocardial infarction (AMI). The participants were 680 patients with AMI who received percutaneous coronary intervention. Shock index is the ratio of heart rate and systolic blood pressure. Patients were classified as admission SI

Little is known about the mid-term outcomes of patients with atrial fibrillation (AF) who undergo coronary stenting in the second-generation drug-eluting stent (DES) era. We evaluated the 1-year outcomes of AF patients undergoing percutaneous coronary intervention (PCI) with second-generation DES. This retrospective cohort analysis used integrated data from the SHINANO registry, a prospective observational multicenter cohort study, which enrolled 1923 consecutive patients undergoing PCI for any coronary artery disease. We retrospectively recruited 917 of these patients (mean age, 71.3 ± 10.0 years; male, 77 %) who received PCI with 2nd generation DES. The primary endpoint was net adverse clinical events (NACE: cardiac death, stroke, MI, stent thrombosis, and major bleeding) at 1 year. The secondary endpoints were major adverse cardiovascular events (MACE: cardiac death, stroke, and MI), stroke, MI, and major bleeding at 1 year. One-year follow-up was completed in 871 (94.9 %) patients, of whom 85 had AF. The incidence of NACE (15.4 vs. 7.3 %, P = 0.008), MACE (10.6 vs. 5.4 %, P = 0.047), and major bleeding (6.0 vs. 2.3 %, P = 0.049) were all significantly higher in AF compared to non-AF patients. On multivariate analysis, AF was an independent predictor of NACE (HR 2.32, 95 % CI 1.24-4.34, P = 0.008). In the second-generation DES era, patients with AF undergoing PCI still have a poorer prognosis, with more thrombotic and bleeding events, than those without AF. More attention should be paid to the thrombotic and bleeding risk in AF patients undergoing PCI.

Inflammatory biomarkers have been proposed for use in the risk stratification of patients with acute myocardial infarction (AMI). We examined the value of inflammatory biomarkers over clinical features for predicting cardiovascular (CV) events in stable outpatients with MI. We enrolled 430 post-MI patients and measured their levels of high-sensitivity C reactive protein (hs-CRP), growth differentiation factor-15 (GDF-15), and the interleukin-1 receptor family member called ST2 (ST2), one month after AMI. Patients were prospectively followed for 3 years. In our study cohort (mean age, 66 ± 12 years; left ventricular ejection fraction, 55 ± 13%), CV events were observed in 39 patients (9.1%). Kaplan- Meier analysis revealed that patients with high levels of GDF-15 (≥ 1221.0 ng/L) showed poorer prognoses than those with low levels of GDF-15 (< 1221.0 ng/L) (20.4% versus 3.6%, P < 0.001); hs-CRP and ST2 did not show a similar correlation with prognoses. GDF-15 remained associated with CV events after adjusting for age, chronic kidney disease, and B-type natriuretic peptide (hazard ratio, 1.001; 95% confidence interval, 1.000 - 1.001; P = 0.046). GDF-15 provided an incremental predictive value for CV events over clinical features (incremental value in global χ(2) = 43.81, P < 0.001). In outpatients with prior MI, GDF-15 was an independent indicator of CV events, unlike hs-CRP and ST2. GDF15 provided an incremental prognostic value over clinical features.

The Synergy Between PCI With TAXUS and Cardiac Surgery (SYNTAX) score is effective in predicting clinical outcome after percutaneous coronary intervention (PCI). However, its prediction ability is low because it reflects only the coronary characterization. We assessed the predictive value of combining the ankle-brachial index (ABI) and SYNTAX score to predict clinical outcomes after PCI. The ABI-SYNTAX score was calculated for 1,197 patients recruited from the Shinshu Prospective Multi-center Analysis for Elderly Patients with Coronary Artery Disease Undergoing Percutaneous Coronary Intervention (SHINANO) registry, a prospective, observational, multicenter cohort study in Japan. The primary end points were major adverse cardiovascular and cerebrovascular events (MACE; all-cause death, myocardial infarction, and stroke) in the first year after PCI. The ABI-SYNTAX score was calculated by categorizing and summing up the ABI and SYNTAX scores. ABI ≤ 0.49 was defined as 4, 0.5 to 0.69 as 3, 0.7 to 0.89 as 2, 0.9 to 1.09 as 1, and 1.1 to 1.5 as 0; an SYNTAX score ≤ 22 was defined as 0, 23 to 32 as 1, and ≥ 33 as 2. Patients were divided into low (0), moderate (1 to 2), and high (3 to 6) groups. The MACE rate was significantly higher in the high ABI-SYNTAX score group than in the lower 2 groups (low: 4.6% vs moderate: 7.0% vs high: 13.9%, p = 0.002). Multivariate regression analysis found that ABI-SYNTAX score independently predicted MACE (hazards ratio 1.25, 95% confidence interval 1.02 to 1.52, p = 0.029). The respective C-statistic for the ABI-SYNTAX and SYNTAX score for 1-year MACE was 0.60 and 0.55, respectively. In conclusion, combining the ABI and SYNTAX scores improved the prediction of 1-year adverse ischemic events compared with the SYNTAX score alone.

The exercise ankle-brachial index (ABI) helps diagnose lower extremity peripheral artery disease (PAD). Patients with comorbidities may be unable to perform treadmill exercise, the most common stress loading test. While the active pedal plantar flexion (APP) test using the leg loader, simple and easy stress loading device, could be an alternative, there are no data comparing the leg loader and treadmill exercise. Therefore, we aimed to compare APP using the leg loader and treadmill exercise to evaluate PAD. A total of 27 patients (54 limbs) diagnosed with PAD with intermittent claudication and considered for angiography and/or endovascular treatment were recruited prospectively, and both the leg loader and treadmill were performed. There was a strong correlation (r = 0.925, p

Diabetes is known to be one of the risks of arteriosclerosis. However, the therapeutic goal of HbA1c in diabetic elderly is still unclear, in particular, in secondary prevention after percutaneous coronary intervention (PCI). Between August 2012 and July 2013, a total of 1665 consecutive patients

BACKGROUND The geriatric nutritional risk index (GNRI) is a simple and objective nutritional assessment tool for elderly patients. Lower GNRI values are associated with a worse prognosis in patients with heart failure (HF). However, few data are available regarding the prognostic effect of the GNRI value for risk stratification in patients at risk for HF.Methods and Results:We retrospectively investigated 1,823 consecutive patients at risk for HF (Stage A/B) enrolled in the IMPACT-ABI Study. GNRI on admission was calculated as follows: 14.89×serum albumin (g/dL)+41.7×body mass index/22. Patients were divided into 2 groups according to the median GNRI value (107.1). The study endpoint was a composite of cardiovascular (CV) events, including CV death and hospitalization for worsening HF. Over a 4.7-year median follow-up, CV events occurred in 130 patients. In the Kaplan-Meier analysis, patients with low GNRI (

We evaluated whether underweight status is associated with poor prognosis in patients with peripheral artery disease (PAD) with claudication, excluding critical limb ischemia. We identified 441 claudicants hospitalized for cardiovascular disease between 2005 and 2012. Patients were divided into 4 groups according to body mass index (BMI): an underweight group (BMI < 18.5 kg/m2; n = 48), a normal group (BMI = 18.5-25.0 kg/m2; n = 286), an overweight group (BMI = 25.0-30.0 kg/m2; n = 92), and an obese group (BMI ≥ 30.0 kg/m2; n = 15). The mean follow-up period was 3.5 ± 1.9 years. The underweight group had significantly lower levels of hemoglobin, albumin, estimated glomerular filtration rate, triglycerides, and hemoglobin A1c; higher levels of C-reactive protein and B-type natriuretic peptide; and a higher prevalence of hemodialysis. The incidence of all-cause death and cardiovascular death was significantly higher in the underweight group (underweight vs normal, 77.1% vs 33.0%; P < .001 and 43.3% vs 14.4%; P < .001, respectively). In a multivariate Cox analysis, underweight status was an independent predictor of all-cause death (hazard ratio, 2.53; 95% confidence interval, 1.58-4.18; P < .001). Therefore, promoting weight gain, as well as managing cardiovascular disease, may be important for underweight patients with PAD.

Concomitant coronary and peripheral artery disease is associated with higher periprocedural and long-term percutaneous coronary intervention (PCI) complication rates. We evaluated in-hospital and 1-year clinical outcomes of patients with low or borderline ankle–brachial indexes (ABIs) undergoing PCIs in the drug-eluting stent era. We divided 1370 SHINANO registry patients into 3 groups—low (ABI ≤ 0.9), borderline (0.9 < ABI ≤ 1.0), and normal (1.0 ≤ ABI < 1.4). During the 1-year follow-up, more PCI-related complications occurred in the low and borderline ABI groups than in the normal ABI group (7.7% vs 8.8% vs 4.0%, respectively). Low ABI patients were more likely to experience adverse clinical events (6.3% vs 3.6% vs 3.0%, respectively; log-rank P = .020 for low vs normal ABI), with a hazard ratio of 2.27 (95% confidence interval, 1.12-4.61; P = .023), compared with patients with normal ABIs. Patients with abnormal ABIs had a significantly higher incidence of PCI-related complications and a less favorable 1-year prognosis. Routine ABI measurement before PCI may help predict PCI-related complication incidence and 1-year prognosis.