Masahiko Fujihara

Predictors of adverse clinical outcomes after successful infrapopliteal intervention

To clarify the clinical and angiographical variables related to delayed wound healing, major amputation and death after successful infrapopliteal intervention in critical limb ischemia patients with tissue loss.

Endovascular therapy by CO2 angiography to prevent contrast‐induced nephropathy in patients with chronic kidney disease: A prospective multicenter trial of CO2 angiography registry

To assess the safety and efficacy of carbon dioxide (CO2) angiography‐guided endovascular therapy (EVT) for renal, iliofemoral artery disease.

Assessment of Macro- and Microcirculation in Contemporary Critical Limb Ischemia

Objectives: A paucity of data exists regarding manifestations of macro‐ and microcirculation in contemporary critical limb ischemia (CLI). The aim of this study was (1) to evaluate the differences in foot circulation based on angiographic findings, (2) to clarify the relationship between macro‐ and microcirculation, and (3) to investigate the effects of postural changes on micro as well as macrocirculation between the supine position to the dependent position. Methods: A total of 40 critically ischemic limbs in 29 patients were included in this study. Noninvasive evaluation of macrocirculation, based on the ankle brachial index (ABI) and ankle pressure, and microcirculation, using skin perfusion pressure (SPP), was performed in both the supine and dependent positions. Results: There was no significant difference in macro‐ and microcirculations between any angiographical involvements. In the supine position, dorsal SPP correlated significantly with ABI (P = 0.021, r = 0.363) and ankle‐pressure (P = 0.001, r = 0.495), whereas plantar SPP failed to correlate with ABI (P = 0.198, r = 0.208) or ankle‐pressure (P = 0.185, r = 0.214). In the dependent position, however, SPP showed no significant correlation with ABI and ankle pressure. Postural change from the supine to dependent position yielded a significant increase in SPP (dorsal: 37.2 ± 16.2 to 77.9 ± 17.7 mm Hg, P < 0.001; plantar: 33.6 ± 17.3 to 75.7 ± 18.3 mm Hg, P < 0.001) as well as ABI and ankle‐pressure (ABI: 0.70 ± 0.35 to 0.78 ± 0.42, P = 0.003; ankle‐pressure; 108 ± 61 to 111 ± 60 mm Hg, P = 0.038). The effect of postural change on SPP showed no difference between patients with and without any clinical and angiographical complications. Conclusions: Of microcirculation assessed, only dorsal SPP correlated significantly with macrocirculation in the supine position. Furthermore, postural change from the supine to dependent position produced a dramatic improvement in microcirculation due to the effects of gravity.

Long-term results of primary stenting for subclavian artery disease

To evaluate initial and long‐term results of endovascular therapy (EVT) for symptomatic subclavian artery (SCA) disease. Background: EVT for SCA disease has a similar success rate as open surgery, but the long‐term patency of EVT alone is uncertain.

Perioperative and Long-term Outcomes of Endovascular Treatment for Subclavian Artery Disease From a Large Multicenter Registry.

Purpose: To investigate the perioperative and long-term outcomes of endovascular therapy (EVT) for subclavian artery disease in a large-scale multicenter study. Methods: The study analyzed the outcomes from a multicenter retrospective registry (SubClavian Artery disease treated with endovascuLar therapy; muLticenter retrOsPective registry: SCALLOP) of 718 consecutive patients with upper extremity artery disease who underwent EVT between January 2003 and December 2012 at 37 Japanese cardiovascular centers. Of the 718 patients enrolled in the registry, 162 patients were excluded, leaving 553 patients (mean 70±7 years, range 41–91; 405 men) who underwent primary EVT for de novo subclavian artery disease (560 arms). Results: Procedure success was achieved in 96.8% (100% for stenoses, 91% for total occlusions). The perioperative complication rate was 9.2%. Stroke was found in 1.8%, with ipsilateral posterior infarction accounting for 0.9%. The 30-day mortality was 0.7%. The mean follow-up was 39±24 months. Primary patency estimates were 90.6%±1.3%, 83.4%±1.8%, and 80.5%±2.2% at 1, 3, and 5 years, respectively. There was no significant difference in primary patency between stenotic and occlusive lesions. Secondary patency estimates were 99.2%±0.4%, 98.2%±0.6%, and 97.7%±0.8% at 1, 3, and 5 years, respectively. The respective overall survival rates were 94.6%±1.0%, 86.8%±1.7%, and 79.0%±2.4%. There were 86 deaths during follow-up, of which half were due to cardiovascular causes. On multivariate analysis, critical hand ischemia (hazard ratio [HR] 4.6, 95% CI 2.06 to 10.2, p<0.001), cerebrovascular disease (HR 1.9, 95% CI 1.14 to 3.06, p=0.01), current smoking (HR 1.8, 95% 1.14 to 2.79, p=0.01), and lesion length (in 1-cm increments; HR 1.02, 95% CI 1.00 to 1.04, p=0.03) were negative independent predictors of primary patency, while IVUS use (HR 0.6, 95% CI 0.30 to 0.96, p=0.04) was a positive predictor of primary patency. Conclusion: Primary angioplasty/stenting for subclavian artery disease afforded acceptable outcomes in terms of perioperative complications and long-term patency.

Duplex criteria for in‐stent restenosis in the superficial femoral artery

Objectives: To elucidate the optimal cutoff and accuracy of duplex ultrasonography (DUS) parameters for in‐stent restenosis (ISR) after nitinol stenting in the superficial femoral artery (SFA). Background: Few data are available regarding the performance of DUS for binary ISR based on quantitative vessel analysis (QVA) in the era of SFA nitinol stenting. Methods: This retrospective study included 74 in‐stent stenoses of SFA who underwent DUS before follow‐up angiography. DUS parameters, such as peak systolic velocity (PSV) and the peak systolic velocity ratio (PSVR), were compared with percent diameter stenosis (%DS) from a QVA basis. Results: There was a statistically significant correlation (P < 0.001) between “%DS and PSV” and “%DS and PSVR,” and the correlation with %DS proved to be stronger in PSVR (R = 0.720) than in PSV (R = 0.672). The best performing parameter for ISR (50% or greater stenosis) was revealed PSVR, as the areas under the receiver operator characteristics curves using PSVR and PSV were 0.908 and 0.832, respectively. A PSVR cut off value of 2.85 yielded the best predictive value with sensitivity of 88%, specificity of 84%, and accuracy of 86%. The positive predictive value was 85% and the negative predictive value was 88%. Conclusions: A PSVR of 2.85 is the optimal threshold for ISR after nitinol stenting in the SFA. Further large prospective studies are required for the validation and establishment of uniform criteria for DUS parameters.

Clinical outcome of renal artery stenting for hypertension and chronic kidney disease up to 12 months in the J-RAS Study – prospective, single-arm, multicenter clinical study.

BACKGROUND Atherosclerotic renal artery stenosis (ARAS) causes renovascular hypertension (HTN) and impairs renal function, leading to chronic kidney disease (CKD). The J-RAS study was a prospective, multicenter study to assess the clinical outcome of renal artery stenting for up to 1 year in Japanese patients with ARAS. METHODS AND RESULTS One hundred and forty-nine patients were enrolled between November 2010 and January 2013. The patients were classified into an HTN (n=121) group and a CKD (n=108) group in the primary analysis. The primary efficacy endpoints were change in blood pressure for the HTN group and change in estimated glomerular filtration rate (eGFR) for the CKD group at 1 months. The primary safety endpoint was freedom from major cardiovascular or renal events at 12 months. In the HTN group, the mean systolic blood pressure (SBP) significantly decreased from 161.6 ± 21 mmHg at baseline to 137.0 ± 21 mmHg (P<0.0001). In the CKD group, there was no significant difference in eGFR from 40.7 ± 10 ml·min(-1)·1.73 m(-2)at baseline to 40.8 ± 13 ml·min(-1)·1.73 m(-2)(P=0.32). The primary safety endpoint was 89.4% at 12 months. CONCLUSIONS In the J-RAS trial, significant SBP reduction was seen in the HTN group, and stabilization of renal function in the CKD group. Renal artery stenting for ARAS is safe and effective in Japanese patients.

Impact of end-stage renal disease in patients with critical limb ischaemia undergoing infrapopliteal intervention

AIMS This study aimed to investigate the impact of end-stage renal disease (ESRD) on clinical outcomes following infrapopliteal intervention in critical limb ischaemia patients with tissue loss. This retrospective single-centre study enrolled 92 consecutive patients (117 limbs) undergoing infrapopliteal intervention for the treatment of ischaemic tissue loss. The primary outcomes were the wound healing rate, the clinically driven reintervention rate and the limb salvage rate. The secondary outcome was amputation-free survival. The pedal arch was significantly (p=0.002) more diseased in ESRD patients than in non-ESRD patients. ESRD patients demonstrated a significantly lower wound healing rate (hazard ratio [HR], 0.552; 95% CI: 0.319-0.957; p=0.034) and a higher reintervention rate (HR, 1.988; 95% CI: 1.135-3.482; p=0.016). However, there was no significant difference in limb salvage rate between patients with and without ESRD. Age (HR, 1.056; 95% CI: 1.020-1.094; p=0.002), ESRD (HR, 2.239; 95% CI: 1.138-4.407; p=0.020), heart failure (HR, 2.360; 95% CI: 1.295-4.302; p=0.005) and infectious wound (HR, 2.017; 95% CI: 1.145-3.552; p=0.015) were independently associated with death or major amputation. ESRD patients yielded a more affected pedal arch and were at approximately twice the risk of wound healing failure, need for reintervention, and death or major amputation compared to non-ESRD patients.

Reduced Plasma Eicosapentaenoic Acid–Arachidonic Acid Ratio in Peripheral Artery Disease

A reduced ratio of plasma eicosapentaenoic acid–arachidonic acid (EPA-AA) is a newly recognized atherosclerotic risk factor. This ratio has not been fully investigated in peripheral artery disease (PAD). Seventy Japanese patients with atherosclerotic risk factors were enrolled and divided into 2 groups, those with PAD (group A: n = 38) and those without PAD (group B: n = 32). The EPA-AA ratio (P = .001) and ankle–brachial index (ABI: P < .001) in group A were significantly lower than those in group B. Univariate and multivariate analyses demonstrated that EPA-AA, ABI, and prescription of clopidogrel had significant correlation with PAD. Given the appropriate cutoff values, EPA-AA (odds ratio [OR] = 11.7, 95% confidence interval [CI] = 3.0-45.8; P < .001) and ABI (OR = 44.0, 95% CI = 5.4-358.5; P < .001) are factors independently associated with PAD. In conclusion, this study demonstrated that reduced plasma EPA/AA may underlie PAD at least in Japanese.

Influence of common cardiac drugs on gastroesophageal reflux disease: Multicenter questionnaire survey

BACKGROUND Although gastroesophageal reflux disease (GERD) causes noncardiac chest pain mimicking angina pectoris, systemic studies surveying the effects of common cardiac drugs on symptomatic GERD are rare. METHODS To investigate the drugrelated GERD, this multicenter trial enrolled 201 consecutive cardiac outpatients (69.7 ± 10.5 y) after obtaining written informed consent. They were assessed using the Frequency Scale for Symptoms of GERD (F-scale) to screen for GERD with a cut-off value of 8.0. Clinical background was obtained from medical records. Gastric medicine was empirically administered at the discretion of the attending physician. F-scale score and incidence of GERD were analyzed individually in relation to background and prescription. RESULTS The average F-scale score did not correlate with gender, age or underlying diseases. F-scale score was elevated significantly (p = 0.006) by administration of calcium channel blockers to the patients treated with gastric medicine, suggesting that calcium channel blockers exacerbate the possibly preexisting GERD. Incidence of GERD within 2 months after starting warfarin tended to be greater than that at other durations (p = 0.087). Patients showing a high score (≥ 8.0) suggestive of GERD showed a correlation with the combined administration of calcium channel blockers (OR = 3.19; 95% CI of 1.01 - 10.11; p = 0.049) and warfarin (OR = 3.05; 95% CI of 1.00 - 9.27; p = 0.049) in the best logistic model. CONCLUSION Although larger cohort is required, this survey demonstrates that the combination of calcium channel blockers and warfarin is an independent risk factor for GERD.