Association between complete revascularization of the coronary artery and clinical outcomes in peripheral artery disease: a sub-analysis of the I-PAD Nagano registry.

Peripheral artery disease (PAD) is commonly caused by atherosclerosis and has an unfavorable prognosis. Complete revascularization (CR) of the coronary artery reduces the risk of major adverse cardiovascular event (MACE) in patients with coronary artery disease (CAD). However, the impact of CR in patients with PAD has not been established to date. Therefore, we evaluated the impact of CR of CAD on the five-year clinical outcomes in patients with PAD. This study was based on a prospective, multicenter, observational registry in Japan. We enrolled 366 patients with PAD undergoing endovascular treatment. The primary endpoint was MACE, defined as a composite of all-cause death, non-fatal myocardial infarction, and non-fatal stroke. After excluding ineligible patients, 96 and 68 patients received complete revascularization of the coronary artery (CR group) and incomplete revascularization of the coronary artery (ICR group), respectively. Freedom from MACE in the CR group was significantly higher than in the ICR group at 5 years (66.7% vs 46.0%, p < 0.01). Multivariate analysis revealed that CR emerged as an independent predictor of MACE (Hazard ratio: 0.56, 95% confidential interval: 0.34-0.94, p = 0.03). CR of CAD was significantly associated with improved clinical outcomes in patients with PAD undergoing endovascular treatment.

Successful endovascular treatment with a stent graft for chronic deep vein thrombosis with multiple arteriovenous fistulas: a case report.

BACKGROUND: Deep vein thrombosis with arteriovenous fistulas is rare, with few therapeutic options available for chronic-phase deep vein thrombosis. Moreover, the effectiveness of endovascular treatment for chronic-phase deep vein thrombosis with arteriovenous fistulas has not been established. We describe herein a case of successful endovascular treatment for chronic deep vein thrombosis with multiple arteriovenous fistulas. CASE PRESENTATION: We describe the case of a 72-year-old Asian woman who had begun experiencing left leg swelling and intermittent claudication 2 years prior. Enhanced computed tomography revealed left common iliac vein occlusion with vein-to-vein collateral formation and several arteriovenous fistulas. Angiography and ultrasound showed the arteriovenous fistulas to run from the common and internal iliac arteries to the external iliac and superficial femoral veins. We opted against surgical repair for the arteriovenous fistulas due to their complex nature and complicated morphology. Since her condition was progressive, endovascular treatment with a stent graft was performed for the deep vein thrombosis, after which her symptoms gradually improved. Four months following the procedure, enhanced computed tomography confirmed remarkable reduction of the vein-to-vein collaterals and arteriovenous fistulas. CONCLUSIONS: In the present case, enhanced computed tomography with a stent graft was effective in improving symptoms. This strategy may therefore be a treatment option for intractable chronic deep vein thrombosis with arteriovenous fistulas.

Intensive exercise therapy for restenosis after superficial femoral artery stenting: the REASON randomized clinical trial.

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).

Effects of cardiac surgical support on long-term outcomes of emergent or complex percutaneous coronary intervention cases: a sub-analysis of the SHINANO 5-year registry.

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 < 0.01 and 24.9% vs. 39.2%, p < 0.01, respectively), and a higher prevalence of hemodialysis and history of peripheral artery disease (7.6% vs. 2.45%, p < 0.01 and 12.1% vs. 6.9%, p < 0.01, respectively). However, the Kaplan-Meier analysis showed no difference in the 5-year mortality rate (16.4% vs. 15.2%, 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.

Body composition and mortality in patients undergoing endovascular treatment for peripheral artery disease.

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/m2 and 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 < 0.001 and HR: 4.48; 95% CI 1.58-12.68, p = 0.005, respectively], for age, sex, hemodialysis, and prior cerebral cardiovascular disease (HR: 3.63; 95% CI 1.93-6.82; p < 0.001 and HR: 4.03; 95% CI 1.43-11.42, p = 0.009, respectively) and for age, sex, and laboratory date (HR: 3.97; 95% CI 1.88-8.37; p < 0.001 and HR: 3.31; 95% CI 1.15-9.53, 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.

Prognostic ability of mid-term worsening renal function after percutaneous coronary intervention: findings from the SHINANO registry.

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 < 0.001), and all-cause death (p < 0.001), myocardial infarction (p = 0.001). Furthermore, mid-term WRF patients had higher incidence of future heart failure (p < 0.001) and new-onset atrial fibrillation (p = 0.01). Patients with both mid-term WRF and chronic kidney disease had increased MACE compared to patients with either condition alone (p < 0.001). Similarly, patients with mid-term WRF and acute kidney injury had increased MACE compared to patients with either condition alone (p < 0.001). Multivariate Cox regression analysis revealed mid-term WRF as a strong predictor of MACE (hazard ratio: 2.50, 95% confidence interval 1.57-3.98, p < 0.001). Mid-term WRF after PCI negatively affects MACE, as well as future admission due to heart failure and new-onset atrial fibrillation, chronic kidney disease, and acute kidney injury.

A case of Dressler's syndrome successfully treated with colchicine and acetaminophen.

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. .

Association of the Prognosis of Ankle-brachial Index Improvement One Year Following Endovascular Therapy in Patients with Peripheral Artery Disease: Data from the I-PAD NAGANO Registry.

Objective Despite reports on the effects of ankle-brachial index (ABI) improvement following endovascular therapy (EVT) on the limb prognosis, studies evaluating cardiovascular events are limited. We investigated whether or not ABI improvement 1 year following EVT was associated with cardiovascular events. Methods The I-PAD NAGANO registry is an observational multicenter cohort study that enrolled 337 patients with peripheral artery disease (PAD) who underwent EVT between August 2015 and July 2016. From this cohort, we identified 232 patients whose ABI data 1 year following EVT were available, after excluding patients with critical limb ischemia. We divided the patients into two groups according to the degree of ABI improvement 1 year following EVT (ΔABI) - the ΔABI <0.15 group and the ΔABI ≥0.15 group - and compared the outcomes. The primary endpoint was major adverse cardiovascular events (MACEs), including all - cause death, myocardial infarction (MI), and stroke. The secondary endpoints were major adverse limb events (MALEs), defined as a composite of target lesion revascularization and major amputation, all - cause death, MI, and stroke. The median follow-up period was 3.3 years. Results The incidence of MACEs was significantly higher in the ΔABI <0.15 group than in the ΔABI ≥0.15 group (ΔABI <0.15 vs. ΔABI ≥0.15, 25.8% vs. 11.9%, log-rank p=0.036), as was the incidence of stroke (14.1% vs. 2.2%, log-rank p=0.016). A Cox regression analysis revealed that ΔABI ≥0.15 was significantly associated with fewer MACEs (hazard ratio 0.38, 95% confidence interval 0.17-0.83, p=0.016). Conclusion An increase in ABI ≥0.15 at 1 year following EVT was a predictor of reduced MACEs.

Prognostic significance of diastolic blood pressure in patients with heart failure with preserved ejection fraction.

Although systolic blood pressure (SBP) is routinely considered when treating acute heart failure (HF), diastolic blood pressure (DBP) is hardly been assessed in the situation. There are no previous studies regarding the predictive value of DBP in elderly patients with HF with preserved ejection fraction (HFpEF) in Japan. This study aimed to investigate the prognostic significance of DBP in patients with acute decompensated HFpEF. We analyzed data of all HFpEF patients admitted to Shinonoi General Hospital for HF treatment between July 2016 and December 2018. We excluded patients with acute coronary syndrome and severe valvular disease. Patients were divided into two groups according to their median DBP; the low DBP group (DBP ≤ 77 mmHg, n = 106) and the high DBP group (DBP > 77 mmHg, n = 100). The primary outcome was HF readmission. In 206 enrolled patients (median 86 years), during a median follow-up of 302 days, the primary outcome occurred in 48 patients. The incidence of HF readmission was significantly higher in the low DBP group (33.0% vs 18.5%, p = 0.024). In Kaplan-Meier analysis, low DBP predicted HF readmission (Log-rank test, p = 0.013). In Cox proportional hazard analysis, low DBP was an independent predictor of HF readmission after adjustment for age, sex, SBP, hemoglobin, serum albumin, serum creatinine, B-type natriuretic peptide, renin-angiotensin system inhibitors, calcium channel blockers, left ventricular ejection fraction, coronary artery disease, and whether they live alone (hazard ratio, 2.229; 95% confidence interval, 1.021-4.867; p = 0.044). Low DBP predicted HF readmission in patients with HFpEF.

Prognostic impact of mineralocorticoid receptor antagonist in patients with heart failure with preserved ejection fraction.

AIMS: This study aims to investigate the prognostic impact of mineralocorticoid receptor antagonists (MRAs) on cardiovascular events in patients hospitalized for acute decompensated heart failure with preserved ejection fraction (HFpEF; defined as left ventricular ejection fraction ≥45%). METHODS AND RESULTS: A prospective multicentre cohort study was conducted in Nagano prefecture, Japan, between July 2014 and December 2018 that contained 518 consecutive HFpEF patients hospitalized for acute decompensated heart failure (HF). The primary outcome was a composite of cardiovascular death and HF readmission. We compared the incidence of cardiovascular events between patients who were prescribed with MRAs and those who were not in a propensity score matched cohort using a Cox proportional hazards regression model with a propensity score derived from 23 baseline variables. For sensitivity analysis, we conducted Cox proportional hazards regression models for the primary outcome adjusting for 16 clinically relevant variables in the crude cohort. The median age was 83 years, and 53% were female. The median left ventricular ejection fraction was 61%. During a median follow-up of 553 days, the primary outcome occurred in 192 (37%) patients. MRAs were used in 255 (49%) patients. After analysis, a matched cohort consisting of 370 patients was created. After propensity score matching, the baseline characteristics were well balanced between the two groups. The incidence of the primary outcome was significantly lower in MRA users than in non-users [32% (59/185) vs. 49% (90/185); hazard ratio (HR) 0.669, 95% confidence interval (CI) 0.482-0.929, P = 0.016]. The incidence of cardiovascular death was also significantly lower in the MRA users [11% (21/185) vs. 22% (41/185); HR, 0.563; 95% CI, 0.333-0.953; P = 0.032]. The risk of HF readmission tended to be lower in the MRA users [29% (54/185) vs. 41% (75/185); HR, 0.738; 95% CI, 0.520-1.048; P = 0.089]. MRA use was also associated with a lower risk of the primary outcome after Cox proportional hazards analysis adjusting for 16 clinically relevant variables in the crude cohort (HR, 0.710; 95% CI 0.507-0.995; P = 0.047). CONCLUSIONS: Mineralocorticoid receptor antagonist use was significantly associated with a lower risk of the primary composite outcome of cardiovascular death and HF readmission in patients hospitalized for acute decompensated HFpEF. The incidence of cardiovascular mortality was also significantly lower in these patients.

Prognostic significance of resting heart rate in atrial fibrillation patients with heart failure with reduced ejection fraction.

The prognostic significance of resting heart rate (HR) in atrial fibrillation (AF) patients with heart failure with reduced ejection fraction (HFrEF) is unclear, and there are no recommendations about the optimal HR in patients with HF in the current guidelines. Thus, we aimed to identify the relationship between resting HR and mortality in AF patients with HFrEF. A prospective multicenter cohort study was conducted between July 2014 and December 2018. We enrolled consecutive 144 AF patients with HFrEF (mean age 75 years, 34% female). The primary endpoint was all-cause death. We compared the outcomes between the high HR group (HR > 81 beats per minute [bpm], interquartile range [IQR] of HR ≥ 67%, n = 50), and the low HR group (HR ≤ 81 bpm, IQR of HR < 67%, n = 94). During a median follow-up of 538 days, the primary endpoint occurred in 41 (28.5%) patients. In Kaplan-Meier analysis, high HR was associated with a progressively increased risk of mortality (log-rank test, p = 0.034). After multivariate Cox regression analysis, high HR predicted all-cause death after adjusting for age, sex, hemoglobin, estimated glomerular filtration rate, LVEF, use of angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, beta-blockers, digoxin, amiodarone, and calcium channel blockers (hazard ratio, 1.979; 95% confidence interval, 1.005-3.898; p = 0.048). Resting HR > 81 bpm at discharge had a significantly higher risk of death compared with HR ≤ 81 bpm in AF patients with HFrEF.

A Predictive Model for 6-Month Mortality in Elderly Patients with Heart Failure.

Prediction of short-term mortality in elderly patients with heart failure (HF) would be useful for clinicians when discussing HF management or palliative care.A prospective multicenter cohort study was conducted between July 2014 and July 2018. A total of 504 consecutive elderly patients (age ≥ 75 years) with HF (mean age 85 years, 50% women) were enrolled. We used a multiple logistic regression analysis with stepwise variable selection to select predictive variables and to determine weighted point scores. After analysis, the following variables predicted short-term mortality and comprised the risk score: previous HF admission (3 points), New York Heart Association III or IV (2 points), body mass index < 17.7 kg/m2 (4 points), serum albumin < 3.5 g/dL (9 points), and left ventricular ejection fraction < 50% (2 points). The c-statistic was 0.820. We compared mortality in low-risk (0-6 points, n = 188), intermediate-risk (7-13 points, n = 241), and high-risk (14-20 points, n = 75) groups. A total of 43 (8.5%) patients died within 6 months after discharge. Mortality was significantly higher in groups with higher scores (low-risk group, 0.5%; intermediate-risk group, 9.1%; high-risk group, 26.7%; P < 0.001).We developed a predictive model for 6-month mortality in elderly patients with HF. This risk score could be useful when discussing advanced HF therapies, palliative care, or hospice referral with patients.

Prognostic significance of serum albumin in patients with stable coronary artery disease treated by percutaneous coronary intervention.

BACKGROUND: Stable coronary artery disease (CAD) is known to have an increased risk of cardiovascular events. Serum albumin (Alb) is reported as a useful risk-stratification tool in cardiovascular diseases such as acute coronary syndrome or heart failure. However, the association between Alb and stable CAD is unclear. Thus, we aimed to investigate the prognostic significance of Alb in patients with stable CAD. METHODS AND RESULTS: We analyzed the data of all patients admitted to Shinonoi General Hospital between October 2014 and October 2017 for newly diagnosed stable CAD, treated via elective percutaneous coronary intervention, with the exception of old myocardial infarction. We collected data, including Alb, at admission. The primary endpoint was major adverse cardiac events (MACE; defined as all-cause death, non-fatal myocardial infarction, non-fatal stroke). In 204 enrolled patients (median age, 73 years), during a median follow-up of 783 days, 28 experienced MACE. Alb was significantly lower in patients with MACE than in those without (p<0.001). In Kaplan-Meier analysis, low Alb predicted worse prognosis in MACE (p<0.001). In multivariate Cox regression analysis, low Alb levels independently predicted MACE (p<0.001) after adjusting for age and sex (HR 4.128 [95% CI 1.632-10.440], p = 0.003), or, age and C-reactive protein (HR 3.373 [95% CI 1.289-8.828], p = 0.013). CONCLUSIONS: Low Alb levels predicted MACE in patients with stable CAD.

Comparison of Long-Acting and Short-Acting Loop Diuretics in the Treatment of Heart Failure With Preserved Ejection Fraction.

Background: Clinical evidence of the effects of loop diuretics in patients with heart failure with preserved ejection fraction (HFpEF) is lacking. Thus, we compared the impact of azosemide and furosemide, long- and short-acting loop diuretics, in patients with HFpEF. Methods and Results: A prospective multicenter cohort study was conducted between July 2014 and July 2018. We enrolled 301 consecutive patients with HFpEF (median age, 84 years; IQR, 79-88 years; 54.8% female). Azosemide was used in 127 patients (azosemide group), and furosemide in 174 (furosemide group). We constructed Cox models for a composite of cardiac death, non-fatal myocardial infarction, non-fatal stroke, and HF hospitalization (primary endpoints). During a median follow-up of 317 days (IQR, 174-734 days), the primary endpoint occurred in 112 patients (37.2%). On multivariate inverse probability of treatment weighted (IPTW) Cox modeling, the azosemide group had a significantly lower incidence of adverse events than the furosemide group (hazard ratio [HR], 0.46; 95% confidence interval [CI]: 0.27-0.80; P=0.006). Furthermore, on multivariate IPTW Cox modeling for the secondary endpoints, cardiac death (HR, 0.38; 95% CI: 0.17-0.89; P=0.025) and unplanned hospitalization for decompensated HF (HR, 0.50; 95% CI: 0.28-0.89; P=0.018) were also reduced in the azosemide group. Conclusions: Azosemide significantly reduced the risk of adverse events compared with furosemide in HFpEF patients.

Unique angiographic findings in a patient with myocardial ischemia and immunoglobulin G4-related disease.

Immunoglobulin G4-related disease characteristically involves multiple organs including the heart and coronary arteries. Immunoglobulin G4-related coronary artery disease is thought to be due to periarteritis and histopathologically is characterized by marked thickening of the adventitia and periarterial fat with infiltration of immunoglobulin G4-positive plasma cells. Although comprehensive diagnostic criteria require a biopsy for a definite or probable diagnosis of immunoglobulin G4-related disease, obtaining a coronary artery biopsy is difficult and risky. However, imaging findings including coronary angiography and intravascular ultrasound might be useful tools to establish a diagnosis of immunoglobulin G4-related coronary artery disease. We report a case of a 63-year-old man with a history of immunoglobulin G4-related disease who presented with exertional chest pain. We found unique angiographic and intravascular ultrasound features of immunoglobulin G4-related coronary artery disease that distinguished it from those of arteriosclerotic coronary artery disease and suggest that coronary angiography and intravascular ultrasound might be useful tools in the diagnosis of immunoglobulin G4-related coronary artery disease.