Digital Subtraction Angiography Prior to an Amputation for Critical Limb Ischemia (CLI): An Expert Recommendation Statement From the CLI Global Society to Optimize Limb Salvage.

Despite recent guideline updates on peripheral artery disease (PAD) and critical limb ischemia (CLI) treatment, the optimal treatment for CLI is still being debated. As a result, care is inconsistent, with many CLI patients undergoing an amputation prior to what many consider to be mandatory: consultation with an interdisciplinary specialty care team and a comprehensive imaging assessment. More importantly, quality imaging is critical in CLI patients with below-the-knee disease. Therefore, the CLI Global Society has put forth an interdisciplinary expert recommendation for superselective digital subtraction angiography (DSA) that includes the ankle and foot in properly indicated CLI patients to optimize limb salvage. A recommended imaging algorithm for CLI patients is included.

Interim Results of the PROMISE I Trial to Investigate the LimFlow System of Percutaneous Deep Vein Arterialization for the Treatment of Critical Limb Ischemia.

OBJECTIVE: To investigate the feasibility, safety, and effectiveness of the LimFlow stent-graft system in performing percutaneous deep vein arterialization (pDVA) for treatment of critical limb ischemia (CLI) patients ineligible for conventional endovascular or surgical revascularization procedures. METHODS: Ten no-option CLI patients (mean age, 67 ± 11 years; 30% women) were enrolled. All patients were classified as Rutherford class 5 or 6 and were deemed by a committee of experts to be ineligible for endovascular or surgical procedures to restore blood flow. Eighty percent were categorized as stage 4 (high risk of amputation) based on Society for Vascular Surgery wound, ischemia, and foot infection (SVS WIfI) scoring index. The primary safety endpoint was amputation-free survival (AFS) at 30 days. A secondary safety endpoint evaluated AFS at 6 months. Other secondary endpoints included primary patency, wound healing, and technical success. RESULTS: Amputation-free survival was achieved in 100% of patients, with no deaths or index limb above-ankle amputations observed at 30 days and 6 months. Technical success rate was 100%. No procedural complications were reported. Primary patency rates at 1 month and 6 months were 90% and 40%, respectively, with reintervention performed in 30% of patients. By 6 months, 30% of patients experienced complete (100%) wound healing, half of patients had 84%-93% wound healing, and 20% of patients experienced 60% healing. CONCLUSION: pDVA using the LimFlow system is a novel approach for treating patients with no-option CLI and may reduce amputation in this population for whom it would otherwise be considered inevitable. Initial findings from this early feasibility trial are promising and additional study is warranted.

Tibiopedal Access for Crossing of Infrainguinal Artery Occlusions: A Prospective Multicenter Observational Study.

PURPOSE: To report a prospective, multicenter, observational study (ClinicalTrials.gov identifier NCT01609621) of the safety and effectiveness of tibiopedal access and retrograde crossing in the treatment of infrainguinal chronic total occlusions (CTOs). METHODS: Twelve sites around the world prospectively enrolled 197 patients (mean age 71±11 years, range 41-93; 129 men) from May 2012 to July 2013 who met the inclusion criterion of at least one CTO for which a retrograde crossing procedure was planned or became necessary. The population consisted of 64 (32.5%) claudicants (Rutherford categories 2/3) and 133 (67.5%) patients with critical limb ischemia (Rutherford category ≥4). A primary antegrade attempt to cross had been made prior to the tibiopedal attempt in 132 (67.0%) cases. Techniques used for access, retrograde lesion crossing, and treatment were at the operator's discretion. Follow-up data were obtained 30 days after the procedure. RESULTS: Technical tibiopedal access success was achieved in 184 (93.4%) of 197 patients and technical occlusion crossing success in 157 (85.3%) of the 184 successful tibial accesses. Failed access attempts were more common in women (9 of 13 failures). The rate of successful crossing was roughly equivalent between sexes [84.7% (50/59) women compared to 85.6% (107/125) men]. Technical success did not differ significantly based on a prior failed antegrade attempt: the access success rate was 92.4% (122/132) after a failed antegrade access vs 95.4% (62/65) in those with a primary tibiopedal attempt (p=0.55). Similarly, crossing success was achieved in 82.8% (101/122) after a failed antegrade access vs 90.3% (56/62) for patients with no prior antegrade attempt (p=0.19). Minor complications related to the access site occurred in 11 (5.6%) cases; no patient had access vessel thrombosis, compartment syndrome, or surgical revascularization. CONCLUSION: Tibiopedal access appears to be safe and can be used effectively for the crossing of infrainguinal lesions in patients with severe lower limb ischemia.

Percutaneous Transluminal Angioplasty in Patients With Infrapopliteal Arterial Disease: Systematic Review and Meta-Analysis.

BACKGROUND: Contemporary outcomes of percutaneous transluminal angioplasty for the treatment of infrapopliteal atherosclerotic lesions are not well characterized. Hence, a systematic review and meta-analysis was performed to determine the safety and effectiveness of this approach in patients with advanced below-the-knee arterial disease. METHODS AND RESULTS: MEDLINE and EMBASE databases were searched for contemporary studies (2005-2015) on the effects of percutaneous transluminal angioplasty for the treatment of infrapopliteal lesions. A random effects meta-analysis model was used to analyze procedural (technical success, flow-limiting dissection, provisional stent placement) and long-term (primary patency, repeat revascularization, major amputation, all-cause mortality) outcomes. Ultimately, 52 studies encompassing 6769 patients with 9399 below-the-knee lesions were included in the analysis. Technical success was 91.1% (95% confidence interval [CI], 88.8-93.0), and the incidence of flow-limiting dissections and bailout stenting was 5.6% (95% CI, 3.2-9.8) and 9.1% (95% CI, 6.3-12.9), respectively. Outcomes at 1 year were primary patency, 63.1% (95% CI, 57.3-68.6); repeat revascularization, 18.2% (95% CI, 14.5-22.6); major amputation, 14.9% (95% CI, 12.3-18.0); and all-cause mortality, 15.1% (95% CI, 12.8-17.7). Significant heterogeneity and publication bias were observed for most percutaneous transluminal angioplasty outcomes. CONCLUSIONS: Contemporary studies of the use of percutaneous transluminal angioplasty as primary treatment for patients with infrapopliteal arterial disease reveal suboptimal procedural and 1-year clinical outcomes.

Can an elderly woman's heart be too strong? Increased mortality with high versus normal ejection fraction after an acute coronary syndrome. The Global Registry of Acute Coronary Events.

BACKGROUND: Coronary artery disease is the leading cause of death in women. We sought to validate previous clinical experience in which we have observed that elderly women with a very high left ventricular ejection fraction (LVEF) are at increased risk of death compared with elderly women with acute coronary syndromes with a normal LVEF. METHODS: Data from 5,127 elderly female patients (age >65 years) enrolled in the Global Registry of Acute Coronary Events were collected. Patients were divided into 3 groups based on their LVEF: group I had a low ejection fraction (<55%), group II had a normal ejection fraction (55%-65%), and group III had a high ejection fraction (>65%). χ² test and multiple logistic regression analysis were performed. The main outcome measures were death in-hospital and death, stroke, rehospitalization, and myocardial infarction at 6-month follow-up. RESULTS: Hospital mortality was 12% in group I. Patients in group III were more likely to die in-hospital than those in group II (P = .003). Multivariable logistic regression showed that high ejection fraction was an independent predictor of hospital death (odds ratio [OR] 2.5, 95% CI [CI] 1.2-5.2, P = .01), 6-month death (OR 2.0, 95% CI 1.1-3.4, P = .01), and cardiac arrest/ventricular fibrillation (OR 2.5, 95% CI 1.2-5.0, P = .01) compared with the normal ejection fraction group. CONCLUSIONS: Having a very high LVEF (> 65%) is associated with worse survival and higher rates of sudden cardiac death than an LVEF considered to be in the reference range.

Early statin therapy in elderly patients presenting with acute coronary syndrome causing less heart failure.

OBJECTIVES: Elderly patients are less likely to receive statin therapy because of concerns about their side-effects. However, 80% of deaths related to coronary heart disease occur in patients above the age of 65 years. This study evaluated the potential benefit of early administration of statins in elderly patients presenting with an acute coronary syndrome. METHODS: This was a prospective cohort study of 774 elderly patients (>65 years) with acute coronary syndrome. The patients were divided into two groups. The first group, consisting of 611 patients, received statins within the first 24 hours of admission, while the second group, consisting of 163 patients, received statins after the first 24 hours. The end points studied included death, heart failure/pulmonary edema, stroke and recurrent myocardial infarction during hospitalization. RESULTS: Multivariable logistic regression analysis, adjusting for baseline demographics, co-morbidities and chronic statin therapy, showed that the occurrence of heart failure/pulmonary edema during hospitalization was relatively lower among those who received statins within 24 hours of admission (odds ratio: 0.5, 95% CI: 0.27-0.94, p=0.03). The C statistic for the model was 0.79. CONCLUSION: Elderly patients presenting with acute coronary syndrome seem to benefit from early statin therapy, and have significantly lower rates of heart failure and pulmonary edema than those who are administered statins at a later stage.

Comparison of outcomes in acute coronary syndrome in patients receiving statins within 24 hours of onset versus at later times.

The clinical benefits of statins in acute coronary syndromes are well established, but the optimal time for administration in this setting has not been well studied. In this study, patients who had acute coronary syndrome and received statins <24 hours of presentation had lower incidences of death, stroke, reinfarction, heart failure, and pulmonary edema compared with delayed administration. Prompt administration of statins appears to be significantly beneficial in patients who present with an acute coronary syndrome.