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BACKGROUND Percutaneous coronary intervention (PCI) of small-vessel coronary artery disease (SVD) is associated with increased risk of restenosis. The use of drug-coated balloons (DCBs) in SVD has received limited study. OBJECTIVES To assess the outcomes of DCB in the treatment of SVD compared with the standard of care. METHODS We performed a meta-analysis of all studies published between January 2000 and September 2018 reporting the outcomes of DCB versus other modalities in the treatment of de novo SVD. RESULTS Seven studies with 1,824 patients (1,938 lesions) were included (four randomized controlled trials and three observational studies). During a mean follow-up of 14.5 ± 10 months, DCBs were associated with a similar risk of target lesion revascularization (TLR) (OR: 0.99, 95% CI: 0.54, 1.84, P = 97) and major adverse cardiovascular events (MACE) (OR: 0.86, 95% CI: 0.51, 1.45, P = 0.57) compared with drug-eluting stents (DES). During a mean follow-up of 7 ± 1.5 months, DCBs were associated with a significantly lower risk of TLR (OR: 0.19, 95% CI 0.04-0.88, P = 0.03) and binary restenosis (OR: 0.17, 95% CI 0.08-0.37, P =

See Article by Takeji et al Critical limb ischemia (CLI), despite advancements in revascularization technology and technical approaches, continues to be associated with significant morbidity and mortality.1–3 Although most operators consider endovascular approach as the first-line therapy for CLI,2–5 controversy remains as to which approach (medical, endovascular, or surgical) is optimal. Classic considerations in the decision between endovascular versus surgical revascularization have been operator experience, anatomy, availability of conduit, age, and patient comorbidities. Meanwhile, those who are bedridden with or without severe dementia have usually been treated with medical therapy only or major amputation. The ultimate goal for CLI is to provide a therapy that would minimize suffering and allow independent ambulation. Accordingly, many risk scores, including BASIL (Bypass versus Angioplasty in Severe Ischemia of the Leg), PREVENT III (Edifoligide for the Prevention of Infrainguinal Vein Graft Failure), and FINNVASC (Finland National Vascular), have been developed to help in these decisions, but none are widely used. These risk scores, while informative, only provide data on measured comorbidities and lack information on other important risk factors, such as nutritional status, physical fitness, inflammation, degree of tissue loss, and overall health status of the patients. Therefore, a prognostic instrument that could potentially capture these unmeasured confounders would be of significant value in helping physicians and patients make proper treatment decisions and set appropriate expectations. To this end, Yamaji et al6 examined the prognostic value of frailty in patients with CLI. This current study6 adds to the growing body of literature to identify frailty as a potential prognostic measure in patients undergoing revascularization for CLI. The authors prospectively evaluated patients who presented with Rutherford classification IV-VI symptoms and risk-stratified them based on the clinical frailty scale. Clinical follow-up at 2 years demonstrated that those with …

An exercise ankle–brachial index (ABI) test can provide further insight into the functional significance of peripheral artery disease (PAD). The variability in its use, associated patient factors and its relation to patients’ symptoms are unknown. From the international PORTRAIT registry, we identified 1131 patients with PAD. We fit a hierarchical logistic regression model, adjusting for patient factors, country and site, to examine predictors of and variation in ordering exercise ABI testing. We also examined the associations between test components and health status as quantified by the Peripheral Artery Questionnaire (PAQ) using semi-parametric regression methods. Testing was ordered in 22% in the United States versus 80% in the Netherlands and 90% in Australia. Testing was likely to be performed if the patient was male, younger, had typical symptoms and a higher resting ABI, with substantial variability across sites (median odds ratio=5.9, 95% CI: 3.2–19.5). Adjusting for country and site, the resting ABI and all exercise ABI metrics were associated with the PAQ Physical Limitation score. In addition, important components of the test, namely time to onset of claudication, pain-free walking distance (PFWD), and maximum walking distance (MWD), were also associated with PAQ Symptoms and Summary scores. More importantly, even after adjusting for resting ABI, a patient with a post-exercise ABI of 0.29 (25th percentile), compared to 0.61 (75th percentile), achieved 4.4 (95% CI: 0.4–8.4, p=0.031) points less on the PAQ Physical Limitation score. Exercise ABI test use is remarkably variable, and less used in the United States. Its data, specifically PFWD and MWD, might help in objectively assessing the impact of PAD on patients’ functioning and quality of life.

Management of intermediate and high risk acute pulmonary embolism (PE) is challenging. The role of multidisciplinary teams for the care of these patients is emerging. Herein, we report our experience with a pulmonary embolism response team (PERT). We conducted a retrospective chart review on all patients admitted to the Cleveland Clinic main campus who required activation of the (PERT) from October 1, 2014 to September 1, 2016. We extracted data pertaining to clinical presentation, bleeding complications, and pre- and post-discharge imaging. Patients were classified as low, intermediate or high risk PE. Descriptive and continuous variables were collected and analyzed. There were 134 PERT activations. PE was confirmed by CT-PA in 118 patients. Fifteen (13%) patients were classified as low risk, 80 (68%) intermediate risk PE and 23 (19%) high risk PE. Fourteen (12%) patients were treated with catheter directed rtPA, 6 (5%) received full dose (100 mg rtPA), 16 (13%) received systemic half-dose (50 mg rtPA), 6 (5%) underwent a surgical embolectomy and 4 (3%) underwent mechanical thrombectomy. 65 (55%) patients received anticoagulation only, and 8 (7%) patients were managed conservatively without any anticoagulation or advanced therapy. 11 (9%) patients died while during the hospitalization. Fourteen patients had major bleeding events. There were no bleeding events among patients who received systemic low dose or full dose rtPA. A multidisciplinary approach to cases of intermediate risk and high risk PE can be implemented successfully. We saw a relatively low rate of bleeding events with use of rtPA.

While the field of endovascular interventions has evolved in the last decade, technological advancements have rendered drug-coated balloons (DCBs) to be the first line therapy for femoropopliteal artery disease. As the knowledge continues to advance, the application of DCB to the infrapopliteal segments as well as its role in in conjunction with plaque modification to minimize stent utilization, will be further elucidated.

There is limited evidence to guide clinical decision-making for antiplatelet therapy in peripheral artery disease (PAD) in the setting of lower extremity endovascular treatment. The Ticagrelor in Peripheral Artery Disease Endovascular Revascularization Study (TI-PAD) evaluated the role of ticagrelor versus aspirin as monotherapy in the management of patients following lower extremity endovascular revascularization. The trial failed to recruit the targeted number of patients, likely due to aspects of the design including the lack of option for dual antiplatelet therapy, and inability to identify suitable patients at study sites. In response, the protocol underwent amendments, but these changes did not adequately stimulate recruitment, and thus TI-PAD was prematurely terminated. This article describes the rationale for TI-PAD and challenges in trial design, subject recruitment and trial operations to better inform the conduct of future trials in PAD revascularization. ClinicalTrials.gov Identifier: NCT02227368.

Background: Health status outcomes, including symptoms, functional status, and quality of life, are critically important outcomes from patients’ perspectives. The PORTRAIT study (Patient-Centered Outcomes Related to Treatment Practices in Peripheral Arterial Disease: Investigating Trajectories) was designed to prospectively define health status outcomes and examine associations between patients’ characteristics and care to these outcomes among those presenting with new-onset or worsened claudication. Methods and Results: PORTRAIT screened 3637 patients with an abnormal ankle-brachial index and new, or worsened, claudication symptoms from 16 peripheral arterial disease (PAD) specialty clinics in the United States, the Netherlands, and Australia between June 2, 2011, and December 3, 2015. Of the 1608 eligible patients, 1275 (79%) were enrolled. Before treatment, patients were interviewed to obtain their demographics, PAD symptoms and health status, psychosocial characteristics, preferences for shared decision-making, socioeconomic, and cardiovascular risk factors. Patients’ medical history, comorbidities, and PAD diagnostic information were abstracted from patients’ medical records. Serial information about patients’ health status, psychosocial, and lifestyle factors was collected at 3, 6, and 12 months by a core laboratory. Follow-up rates ranged from 84.2% to 91%. Clinical follow-up for PAD-related hospitalizations and major cardiovascular events is ongoing. Conclusions: PORTRAIT systematically collected serial PAD-specific health status data as a foundation for risk stratification, comparative effectiveness studies, and clinicians’ adherence to quality-based performance measures. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT01419080.

Patients with peripheral artery disease (PAD) and intermittent claudication (IC) have impaired functional status and quality of life. However, little is known about which factors are associated with poorer health status at the time of initial presentation for PAD specialty care. Characterization of such features might provide insight into disparities that impact health status in this population. A total of 1258 patients from the United States, the Netherlands and Australia with new or worsened IC were enrolled at their first PAD specialty care visit between June 2011 and December 2015. The mean Peripheral Artery Questionnaire (PAQ) Summary Score (range 0–100), a disease-specific health status measure, was 49.2 ± 21.9. Hierarchical, multivariable linear regression was used to relate patient characteristics to baseline PAQ. Patient characteristics independently associated with poorer health status were age ( p < 0.001), female sex ( p < 0.001), not being married ( p = 0.02), economic burden (moderate/severe vs none, moderate/severe vs some; p = 0.03), difficulty getting care (moderate/severe vs none, moderate/severe vs some; p < 0.001), chronic lung disease ( p = 0.02), back pain ( p < 0.001), bilateral vs unilateral PAD ( p = 0.02), intermittent claudication severity (moderate vs mild, severe vs mild, p < 0.001), and lack of prior participation in an exercise program ( p = 0.005). Disparities in both vascular and non-vascular factors were associated with patients’ health status at the time of presentation and should be addressed by all who care for patients with vascular disease.

On Wednesday, November 1, 2017, the Centers for Medicare and Medicaid Services (CMS) made a public decision to end the transitional pass-through add-on payment for drug-coated balloons beginning January 1, 2018, without creating a new ambulatory payment classification rate for these devices. In this Viewpoint, the authors highlight the disconnect between the CMS's decision not to create a new ambulatory payment classification category for drug-coated balloons despite demonstrated clinical superiority. The authors believe this decision is more in line with a rigid fee-for-service payment system than a value-based system that encourages quality over quantity, and disadvantages both the elderly and the poor. They call on all who advocate for patients with peripheral artery disease to action, encouraging their engagement on CMS decisions regarding payment.

On May 25, 2017, the Centers for Medicare and Medicaid Services (CMS) issued a decision memo establishing coverage for supervised exercise therapy (SET) for Medicare beneficiaries experiencing intermittent claudication due to peripheral artery disease (PAD). A meaningful impact on population health is possible with greater freedom to participate in regular physical activity. The authors of this editorial explain the potential roles of physical therapists in the SET program and argue for further integration of physical therapists through collaborative practice. J Orthop Sports Phys Ther 2017;47(12):892-894. doi:10.2519/jospt.2017.0111.

The purpose of this study was to investigate the effect of post-exercise ankle-brachial index (ABI) on the incidence of lower extremity (LE) revascularization, cardiovascular outcomes, and all-cause mortality in patients with normal and abnormal resting ABI.The clinical and prognostic value of post-exercise ABI in the setting of normal or abnormal resting ABI remains uncertain.A total of 2,791 consecutive patients with ABI testing between September 2005 and January 2010 were classified into group 1: normal resting (NR)/normal post-exercise (NE); group 2: NR/abnormal post-exercise (AE); group 3: abnormal resting (AR)/NE; and group 4: AR/AE. Abnormal post-exercise ABI was defined as a drop of20% from resting ABI as per the American College of Cardiology/American Heart Association guidelines. The primary endpoint was incidence of LE revascularization. Secondary endpoints were major adverse cardiovascular events (MACE) and all-cause mortality. Associations between post-exercise ABI and outcomes were adjusted using multivariable Cox proportional hazard and propensity analyses.Compared with group 1 (NR/NE), group 2 (NR/AE) had increased LE revascularization (propensity-matched adjusted hazard ratio [HR]: 6.63, 95% confidence interval [CI]: 3.13 to 14.04; p0.001) but no differences in MACE or all-cause mortality. When resting ABI was abnormal, group 4 (AR/AE) compared with group 3 (AR/NE), abnormal post-exercise ABI was still associated with increased LE revascularization (adjusted HR: 1.59, 95% CI: 1.11 to 2.28; p = 0.01), which persisted after propensity matching (adjusted HR: 2.32, 95% CI: 1.52 to 3.54; p0.001). Compared with group 1 (NR/NE) and after propensity matching, group 4 (AR/AE) had a significant increase in MACE (adjusted HR: 1.44, 95% CI: 1.09 to 1.90; p = 0.009) and a trend toward increased all-cause mortality (adjusted HR: 1.37, 95% CI: 0.99 to 1.88; p = 0.052); however, group 3 (AR/NE) did not.Post-exercise ABI appears to offer both clinical (lower extremity revascularization) and prognostic information in those with normal and abnormal resting ABI.

The relationship between ankle–brachial index (ABI) remains uncertain relative to clinical and angiographic features of critical limb ischemia (CLI). From July 2011 to February 2013, 89 consecutive patients with CLI had non-invasive testing for indications of rest pain ( n=23, 26%), as well as minor ( n=29, 33%) and major ( n=37, 42%) ischemic tissue loss. All patients subsequently underwent ABI testing and lower extremity angiography with visualization of the infragenicular arteries. Toe–brachial index (TBI) testing was available among 31 of these patients. Among patients with any ischemic tissue loss, 29% had an ABI between 0.7 and 1.4. Patients with rest pain alone had reduced odds of abnormal arterial runoff in univariate (OR 0.75, 95% CI 0.63–0.90; p=0.002) but not multivariate ( p=0.50) analysis. Advanced age, increased ABI, reduced creatinine clearance, hyperlipidemia, and prior coronary artery disease were predictive of abnormal infragenicular runoff. Despite limitations in statistical power, median TBI, compared to ABI, tended to increase when infragenicular arterial runoff was preserved. Overall, the association of TBI with abnormal runoff was not significant ( p=0.38). In conclusion, in the evaluation of CLI, nearly one-third of patients with any ischemic tissue loss had a normal or mildly reduced ABI. Assessment of TBI may augment the diagnostic accuracy of ABI in the evaluation of CLI.

Objectives This study sought to examine operator experience measured by time-related variables on outcomes with protected carotid artery stenting (CAS). Background Studies on experience have focused on operator and institutional CAS volumes alone in the absence of a better metric. Methods Using the CHOICE (Carotid Stenting for High Surgical-Risk Patients; Evaluating Outcomes Through the Collection of Clinical Evidence) multicenter prospective data from October 1, 2006 to June 1, 2012, 5,841 evaluable subjects were identified. Operator experience within this study was assessed using 5 variables for each operator: 1) baseline CAS volume; 2) time from first CAS to each subsequent CAS; 3) time between each CAS; 4) CAS volume in the institution; and 5) medical specialty (cardiology, surgery, or radiology/neurology). Institutional experience was determined by CAS volume within the study. Embolic protection device dwell time was used to assess technical performance, and 30-day death, stroke, or myocardial infarction composed the clinical outcome. Hierarchical logistic regression and linear mixed models were used. Results Cardiologists (p Conclusions The time interval between CAS procedures, specialty assignment, and time from first CAS are important measures of operator experience that may significantly affect technical performance and clinical outcome.

Peripheral artery disease (PAD) has been associated with reduced survival in addition to increased morbidity including amputation, decreased quality of life, and immobility [(1)][1]. Endovascular revascularization has emerged as an attractive alternative to surgical revascularization for the

BACKGROUND: Critical limb ischemia (CLI) is diagnosed by the presence of rest pain, tissue ulceration, or gangrene due to chronic arterial insufficiency. It is unclear what fraction of patients with suspected CLI have severe peripheral artery disease (PAD) on non-invasive functional testing. OBJECTIVES: To describe the distribution of pre-intervention treated limb ankle-brachial indices (ABIs) among patients with CLI undergoing percutaneous vascular intervention (PVI) or surgical revascularization (SR). METHODS: We included patients who underwent lower extremity revascularization for CLI in a multicenter registry in Michigan from January 2012 through June 2015. ABIs were classified as normal (0.91–1.40), mild-moderate (0.41–0.90), and severe (≤0.40). Pre- and post-intervention Peripheral Artery Questionnaire (PAQ) summary scores were assessed in a subset of patients. RESULTS: Among 10,756 patients with signs or symptoms of CLI, 9,113 (84.7%) underwent PVI and 1,643 (15.3%) underwent SR. ABIs were recorded in 4,972 (54.6%) PVI and 1,012 (61.6%) SR patients. Patients undergoing PVI had higher ABIs than those undergoing SR, with substantial variation in both groups [mean±SD, PVI: 0.72±0.29 vs. SR: 0.61±0.29; P

Acute Type A aortic dissection is a surgical emergency. Urgent repair is indicated to avoid complications such as acute aortic insufficiency, coronary ischemia and aortic rupture with cardiac tamponade. This report details the management of a patient with acute Type A aortic dissection complicated by an extensive anterolateral myocardial infarction and cardiogenic shock who was successfully bridged to transplantation with a total artificial heart.

Objectives To quantify changes in ankle and toe pressure from pre- to post-endovascular revascularization for critical limb ischemia (CLI) and examine their association with major adverse limb events (MALE). Background Despite societal guidelines recommendation of routine hemodynamic surveillance following revascularization, little is known about hemodynamic assessment in CLI. Methods Among the 358 patients with CLI from the international multicenter IN.PACT DEEP trial, ankle and toe pressures measurements were available at both baseline and after intervention in 270 and 44 patients, respectively. The change in ankle and toe pressures in response to endovascular revascularization and its association with 1-year MALE (target limb revascularization, amputation, or death) were examined using Kaplan–Meier curves and multivariable Cox proportional hazard analyses. Corresponding optimal cutoff points were also identified. Results The mean increase in ankle and toe pressures following revascularization was 33 and 13 mmHg, respectively. Patients with an improvement of ankle pressure >73 mmHg or toe pressure >1 mmHg had similarly the lowest incidence of MALE (23%), while the highest rate of MALE (50%) was found in those whose toe pressure failed to improve by at least 1 mmHg following intervention. In addition, an increase in ankle pressure >73 mmHg was numerically protective against MALE, and more importantly, an increase in toe pressure of >1 mmHg provided statistically significant protection from MALE (adjusted HR = 0.15, 95% CI: 0.04–0.57, P = 0.005). Conclusions Improvements in toe pressure post revascularization are incremental and rarely normalize. Toe pressure, compared to ankle pressure, is more useful in CLI and predicts future MALE.

Symptomatic peripheral artery disease of the femoral popliteal segment can be treated by surgical and endovascular revascularization, but controversy exists about the best approach. Conventional approaches to revascularization have focused on lesion anatomy to decide on bypass versus endovascular treatment, but advances in endovascular therapy make an endovascular-first approach increasingly feasible-either as a single approach or as an adjunct to short-segment bypass (ie, hybrid procedure). In this review, we discuss the medical, endovascular, and surgical treatment of femoral popliteal revascularization with a special emphasis on advances in percutaneous therapy.

Despite increasing numbers of endovascular interventions to treat arterial and venous disease, scant level 1 evidence is available regarding the role of antithrombotic and antiplatelet therapy in patients undergoing these procedures. The current practice in this regard is heterogeneous and has mainly been driven by data from coronary artery disease and percutaneous coronary intervention. This article discusses the role of antithrombotic and antiplatelet agents for endovascular intervention.

The goals of treatment for critical limb ischemia (CLI) are alleviation of ischemic rest pain, healing of arterial insufficiency ulcers, and improving quality of life, thereby preventing limb loss and CLI-related mortality. Arterial revascularization is the foundation of a contemporary approach to promote amputation-free survival. Angiosome-directed revascularization has become a popular theory of reperfusion, whereby anatomically directed arterial flow is restored straight to the wound bed. Innovations in endovascular revascularization combined with a multidisciplinary strategy of wound care accelerate progress in CLI management. This article highlights advances in CLI management, including the clinical relevance of angiosome-directed revascularization, and provides considerations for future treatment of CLI.

The pathophysiology of atherosclerotic renal artery stenosis (RAS) includes activation of the renin-angiotensin-aldosterone axis with resultant renovascular hypertension. Renal artery stenting has emerged as the primary revascularization strategy in most patients with hemodynamically significant atherosclerotic RAS. Despite the frequency with which hemodynamically significant RAS is observed and high rates of technical success of renal artery stenting, there remains considerable debate among experts regarding the role of medical therapy versus revascularization for renovascular hypertension. Modern, prospective, multicenter registries continue to demonstrate improvement in systolic and diastolic blood pressure with excellent safety profiles in patients with RAS. Modern randomized, controlled clinical trials of optimal medical therapy versus renal stenting particularly designed to demonstrate preservation in renal function after renal artery stenting have demonstrated limited benefit. However, these trials frequently excluded patients that may benefit from renal artery stenting. This document was developed to guide physicians in the modern practical application of renal stenting, to highlight the current limitations in the peer-reviewed literature, to suggest best-practices in the performance of renal stenting and to identify opportunities to advance the field.

Surgical or endovascular revascularization procedures for severe peripheral artery disease (PAD) are typically performed in patients with lifestyle-limiting symptoms or evidence of end-organ ischemia secondary to PAD. The role of endovascular therapy in the treatment of PAD is expanding. Contrast-induced nephropathy is the most important and most frequent renal complication of endovascular interventional procedures. Knowledge about complications and their prevention and management is essential for successful outcomes. This article focuses on renal complications during peripheral artery interventions.

Percutaneous therapies for peripheral artery disease continue to evolve with new techniques and devices. Although guidelines-recommended therapies have impacted cardiovascular morbidity and mortality, endovascular interventions have been shown to reduce limb pain, improve quality of life, and prolong walking distance for those with claudication and to reduce amputation rates among those with critical limb ischemia. Novel devices such as drug-eluting stents and drug-coated balloons have improved patency for moderate-length lesions, whereas others allow treatment of heavily calcified and tortuous segments. New adjunctive devices to cross lesions and reduce or modify associated plaque have also been developed, although level 1 data regarding their efficacy are sparse. There has also been a better mechanistic understanding of lower extremity endovascular treatment using tools such as intravascular ultrasound. This information has highlighted the need for better stent size selection for the femoropopliteal arterial segments and larger balloon diameters for the tibial arteries. Moreover, a wound perfusion approach with direct in-line flow, the so-called angiosome approach, and reconstruction of the pedal loop have been advocated for improved wound healing. Technical advances such as the tibiopedal access and reentry methods have allowed crossing of lesions that were considered no option for the endovascular approach in the past. Collectively, there has been increased awareness, interest, and commitment by various specialty societies and organizations to advance the treatment of peripheral artery disease and critical limb ischemia. This is also evident by the recent coalition of 7 professional societies and organizations that represented >150 000 allied health professionals and millions of patients with peripheral artery disease at the 2015 Centers for Medicaid and Medicare Services Medicare Evidence Development and Coverage Analysis Committee meeting. The percutaneous therapies for peripheral artery disease continue to evolve with longer follow-up with randomized data and larger prospective registries. In the future, it is hopeful that we will treat the lower extremity arteries according to segments, taking into account plaque morphology, luminal versus subintimal crossing, location, and stenotic versus occlusive disease. Until then, we must identify the most cost-effective, efficacious, and safe treatment for each patient. The goal of this article is to aid the practicing vascular specialist consider the optimal choices for the management of patients with vascular disease.

Twenty percent of patients who experience a myocardial infarction (MI) will be readmitted within 30 days of discharge [(1,2)][1]. Previous studies have suggested that the timing of readmission after MI by cause is relatively uniform [(2)][2]. Because hospital reimbursement and payment structures

Prior studies have assessed the prognostic value of a decrease, not an increase, of the post-exercise ankle–brachial index (ABI) among patients with normal resting results. Thus, we sought to evaluate the prognostic significance of an increase in post-exercise ABI among these patients. From a single center vascular laboratory database between September 2005 and January 2010, we retrospectively identified 1437 consecutive patients with a normal resting ABI (1.00–1.40) and available post-exercise results. We classified them into group 1 (normal subjects; post-exercise ABI drop ⩽ 20%, 58%) and group 2 (post-exercise ABI increase, 42%) after excluding those with an ABI drop > 20% (peripheral artery disease) as they had known disease ( n=192). The primary outcome was to assess the risk of ischemic events, defined as a composite of unadjudicated death, stroke, or myocardial infraction (MACE). Associations between groups and outcomes were examined using multivariable Cox proportional hazard and propensity analyses. Both groups had similar prevalence of cardiovascular comorbidities. In unadjusted analysis, group 2 was more likely to have MACE ( p = 0.001). After adjusting for all baseline characteristics, an increase in post-exercise ABI compared to normal subjects was associated with a higher MACE (adjusted HR: 1.70, 95% CI: 1.14–2.53; p=0.009). This association stayed statistically significant after propensity matching (adjusted HR: 1.80, 95% CI: 1.17–2.76; p=0.007). This hypothesis-generating analysis showed that an increase in post-exercise ABI appears to identify a population with a higher risk for MACE. A prospective study of this association and mechanisms of risk should be conducted.

Percutaneous coronary intervention (PCI) of small vessels is associated with an increased risk of restenosis. The use of drug-coated balloons (DCBs) in small-vessel coronary artery disease (CAD) has received limited study. We performed a systematic review and meta-analysis were conducted for all

Randomized controlled trials have shown that drug-coated balloons (DCBs) provide superior results compared with percutaneous transluminal angioplasty (PTA) for the treatment of femoropopliteal artery disease. However, these trials have generally included short lesions, few occlusions, and small sample sizes. The present study was an individual-level pooled analysis of duplex ultrasonography (DUS) core laboratory-adjudicated and clinical events committee-adjudicated IN.PACT Admiral DCB subjects across two randomized controlled trials and two single-arm prospective studies to characterize the safety and effectiveness of DCB compared with PTA.The subjects were treated with DCB (n = 926) or PTA (n = 143). The end points through 12 months included DUS core laboratory-adjudicated primary patency and clinically driven target lesion revascularization (CD-TLR) using Kaplan-Meier estimates and primary safety using proportions. A propensity-matched analysis of DCB (n = 466) to PTA (n = 136) was conducted to address confounders.At 12 months, DCB compared with PTA had significantly greater primary patency (88.8% vs 53.9%; P .001), freedom from CD-TLR (94.3% vs 80.2%; P .001), and better primary safety composite end point (94.1% vs 78.0%; P .001). After propensity-matched analysis, DCB remained superior to PTA at 12 months for primary patency (90.5% vs 53.8%; P .001), freedom from CD-TLR (96.9% vs 80.7%; P .001), and the primary safety composite end point (96.3% vs 78.4%; P .001). Across multiple prespecified subgroup analyses, including provisional stenting, DCB remained persistently superior to PTA.In the largest, DUS core laboratory-adjudicated, multiethnic, pooled DCB series to date, the IN.PACT Admiral DCB demonstrated significantly greater primary patency, freedom from CD-TLR, and better composite safety at 12 months compared with PTA.

Objectives The aim of this study was a comparison of risk-adjusted outcomes of 3 approaches to carotid revascularization in the open heart surgery (OHS) population. Background Without randomized clinical trials, the best approach to managing coexisting severe carotid and coronary disease remains uncertain. Staged carotid endarterectomy (CEA) followed by OHS or combined CEA and OHS are commonly used. A recent alternative is carotid artery stenting (CAS). Methods From 1997 to 2009, 350 patients underwent carotid revascularization within 90 days before OHS at a tertiary center: 45 staged CEA-OHS, 195 combined CEA-OHS, and 110 staged CAS-OHS. The primary composite endpoint was all-cause death, stroke, and myocardial infarction (MI). Staged CAS-OHS patients had higher prevalence of previous stroke (p = 0.03) and underwent more complex OHS. Therefore, the propensity score adjusted multiphase hazard function models with modulated renewal to account for staging, and competing risks were used. Results Using propensity analysis, staged CAS-OHS and combined CEA-OHS had similar early hazard phase composite outcomes, whereas staged CEA-OHS incurred the highest risk driven by interstage MI. Subsequently, staged CAS-OHS patients experienced significantly fewer late hazard phase events compared with both staged CEA-OHS (adjusted hazard ratio: 0.33; 95% confidence interval: 0.15 to 0.77; p = 0.01) and combined CEA-OHS (adjusted hazard ratio: 0.35; 95% confidence interval: 0.18 to 0.70; p = 0.003). Conclusions Staged CAS-OHS and combined CEA-OHS are associated with a similar risk of death, stroke, or MI in the short term, with both being better than staged CEA-OHS. However, the outcomes significantly favor staged CAS-OHS after the first year.

Despite increasing numbers of endovascular interventions to treat arterial and venous disease, scant level 1 evidence is available regarding the role of antithrombotic and antiplatelet therapy in patients undergoing these procedures. The current practice in this regard is heterogeneous and has mainly been driven by data from coronary artery disease and percutaneous coronary intervention. This article discusses the role of antithrombotic and antiplatelet agents for endovascular intervention.

Objectives Our aim was to report outcomes of percutaneous stenting of carotid stenosis in patients with previous neck radiation. Background Post-irradiation carotid disease is often extensive and involves atypical areas. Data regarding outcomes of stenting of these lesions are scarce. Methods We retrospectively reviewed medical records at our institution from January 1998 through May 2010 to determine baseline characteristics, procedural details, and follow-up data of patients who underwent stenting of radiation-associated carotid stenosis. Results Our study included 70 patients who underwent a total of 83 procedures. Of these, 47 patients were male (67%), mean age was 66.3 ± 10.6 years. Mean follow-up was 47.5 months (range from 1 to 155 months). All patients had a history of radiotherapy to the neck area, with laryngeal cancer being the most common reason. Furthermore, 41 patients (58.5%) had previous neck surgery due to malignancies. An embolic protection device was used in 61 (73%) procedures. During the follow-up, 5 (6%) ipsilateral events among a total of 10 (12.0%) ischemic events were observed. There was 1 intraprocedural stroke (1.2%), but there were no other ischemic event at 30 days and 1-year post procedure. Mortality was 4.8% during the first 30 days, 8.6% during the first year and 60% at the end of the study. Restenosis was seen in 2 (2.4%) patients at 1 year and in total nine patients (10.8 %) with long-term follow-up. Conclusions Carotid stenting is a safe and durable treatment option for patients with severe carotid stenosis and neck radiation. © 2012 Wiley Periodicals, Inc.

ObjectivesThis study sought to ascertain causes of death and the incidence of percutaneous coronary intervention (PCI)-related mortality within 30 days.BackgroundPublic reporting of 30-day mortality after PCI without clearly identifying the cause may result in operator risk avoidance and affect hospital reputation and reimbursements. Death certificates, utilized by previous reports, have poor correlation with actual cause of death and may be inadequate for public reporting.MethodsAll patients who died within 30 days of a PCI from January 2009 to April 2011 at a tertiary care center were included. Causes of death were identified through detailed chart review using Academic Research Consortium consensus guidelines and compared with reported death certificates. The causes of death were divided into cardiac and noncardiac and PCI and non–PCI-related categories.ResultsOf the 4,078 PCI, 81 deaths (2%) occurred within 30 days. Of these, 58% died of cardiac and 42% of noncardiac causes. However, only 42% of 30-day deaths were attributed to PCI-related complications. Patients with non–PCI-related, compared with PCI-related, death presented with a higher incidence of cardiogenic shock (15 of 47 [32%] vs. 2 of 34 [6%]; p < 0.01) and cardiac arrest (19 of 47 [40%] vs. 1 of 34 [3%]; p < 0.01). Death certificates had only 58% accuracy (95% confidence interval: 45% to 72%) for classifying patients as experiencing cardiac versus noncardiac death.ConclusionsLess than one-half of 30-day deaths are attributed to a PCI-related complication. Death certificates are inaccurate and do not report PCI-related deaths, which may represent a better marker of PCI quality.

Background: Hydroxymethylglutaryl-coenzyme A reductase inhibitors (statins) reduce perioperative cardiac events in high-risk patients undergoing cardiovascular surgery. However, there is paucity of data on the role of statins in patients undergoing intermediate-risk noncardiac, nonvascular surgery (NCNVS). Hypothesis: Statins are cardioprotective in intermediate-risk NCNVS. Methods: We identified a retrospective cohort of patients undergoing intermediate risk NCNVS. Our composite end point (CEP) included 30-day all-cause mortality, atrial fibrillation (AF), and nonfatal myocardial infarction (MI). A stepwise logistic regression with adjustment using propensity scores was performed to determine if statin therapy was independently associated with the risk reduction of adverse postoperative cardiovascular outcomes. Results: We identified 752 patients. Seventy-five of them (9.97%) developed composite end points; 10 (1.33%) had in-hospital nonfatal MI, 44 (5.85%) developed AF, and 35 (4.65%) died within 30 days. The 30-day all-cause mortality was 31/478 (6.48%) among statin nonusers vs 4/274 (1.45%) for statin users (P < 0.002). As compared with nonusers, patients on statin therapy had a 5-fold reduced risk of 30-day all-cause mortality. Statin therapy was associated with decreased CEP after adjusting for baseline characteristics, with a propensity score to predict use of statins (odds ratio [OR]: 0.54, 95% confidence interval [CI]: 0.30–0.97, P = 0.039). After further adjustment for propensity score, diabetes mellitus, percutaneous coronary intervention, and prior coronary artery bypass grafting, statin therapy proved beneficial (OR: 0.51, 95% CI: 0.28–0.92, P = 0.026). Conclusions: Statin use in the perioperative period was associated with a reduction in cardiovascular adverse events and 30-day all-cause mortality in patients undergoing intermediate-risk NCNVS.

The treatment of resistant hypertension has undergone remarkable advancements in recent years. Endovascular radio frequency renal sympathetic denervation (RSD) has shown initial success in treating resistant hypertension by targeting the connection between the brain and renal sympathetic nerves. However, the encouraging results of first-generation RSD have been tempered by important procedural limitations and a need for long-term results of safety and efficacy. In an effort to build on early clinical success, several second-generation RSD technologies are now being developed that may improve procedural safety and efficacy. Preliminary evidence for some of the latest technologies is now available. In this review, we summarize the current evidence in support of RSD and consider unique features of several new technologies that are likely to refine the endovascular treatment of resistant hypertension.

Over 500,000 patients each year are diagnosed with critical limb ischemia (CLI), the most severe form of peripheral artery disease. CLI portends a grim prognosis; half the patients die from a cardiovascular cause within 5 years, a rate that is 5 times higher than a matched population without CLI. In 2014, the Centers for Medicare and Medicaid Services paid approximately $3.6 billion for claims submitted by hospitals for inpatient and outpatient care delivered to patients with CLI. Although significant advances in diagnosis, treatment, and follow-up of patients with CLI have been made, many challenges remain. In this article, we summarize selected presentations from the 2015 Vascular Interventional Advances Conference related to the modern demographics, diagnosis, and management of patients with CLI.

Background The significance of hospital readmission after endovascular therapy for critical limb ischemia ( CLI ) is not well established. We sought to investigate the incidence, timing, and causes of readmissions after endovascular therapy for CLI and whether readmission is associated with major adverse limb events ( MALE ) or mortality. Methods and Results This was a retrospective study of 252 patients treated with endovascular therapy for CLI . During median follow‐up of 381 days (interquartile range [ IQR ], 115–718), 140 (56%) were readmitted, with median time to readmission of 83 days ( IQR, 33–190). Readmission within 30 days occurred in 14% of patients (n=35; 25% of readmissions). Most readmissions occurred between 30 and 180 days (n=67; 48% of readmissions). The most frequent reason for readmission was unhealed wounds (n=63; 45% of readmissions). Independent predictors of readmission by Cox proportional hazards analysis were unhealed wounds, presence of multiple wounds, age ≥70, female sex, hemodialysis, and history of heart failure ( P P P MALE (major amputation, bypass, or endarterectomy) or mortality (adjusted hazard ratio, 3.1; 95% CI , 1.5–6.5; P =0.002). Conclusions Most readmissions occur 30 and 180 days after endovascular therapy for nonprocedural reasons. Unhealed wounds are an independent risk factor for readmission. Readmission is associated with increased MALE and mortality after endovascular therapy for CLI .

Revascularization for critical limb ischemia (CLI), the most advanced form of peripheral artery disease, is the only treatment that has shown to reduce amputations.1 Indeed, all societal guidelines have given a class I indication for revascularization in patients with CLI.2,3 However, individuals with CLI frequently present with multilevel disease where >70% have some degree of infrapopliteal involvement, and these lesions are typically occluded and long.4 Although there have been significant advances in the femoropopliteal segment with drug-eluting stents (DES) and drug-coated balloons, little progress has been made for the treatment of infrapopliteal disease.5 Yet, the rates of amputation and mortality continue to decline in patients with CLI, whereas surgical bypass has significantly decreased.6 Given the paucity of advances for infrapopliteal disease, Mustapha et al,7 in this issue of Circulation: Cardiovascular Interventions , examined the current state of angioplasty for the treatment of infrapopliteal disease through conducting a meta-analysis and a systematic review of all studies from 2005 to 2015.7 See Article by Mustapha et al The authors analyzed 52 contemporary studies of 6769 patients with ≈9400 infrapopliteal atherosclerotic lesions in patients with CLI (97%). They found a technical success rate of 91% with a 63% primary patency. Rates of major amputation (15%) and all-cause mortality (15%) were also similar to those of Romiti et al,8 previously published in 2008. The authors concluded that there were suboptimal short- and long-term clinical outcomes with angioplasty in patients with CLI. The authors should be congratulated for conducting this contemporary analysis of patients with CLI undergoing angioplasty alone. However, as indicated by the investigators, the robustness of this meta-analysis is markedly limited because of the incompleteness …

Critical limb ischemia (CLI), the most advanced form of peripheral artery disease, is associated with significant morbidity, mortality, and health care resource utilization. It is also associated with physical, as well as psychosocial, consequences such as amputation and depression. Importantly, after a major amputation, patients are at heightened risk of amputation on the contralateral leg. However, despite the technological advances to manage CLI with minimally invasive technologies, this condition often remains untreated, with significant disparities in revascularization and amputation rates according to race, socioeconomic status, and geographic region. Care remains disparate across medical specialties in this rapidly evolving field. Many challenges persist, including appropriate reimbursement for treating complex patients with difficult anatomy. This paper provides a comprehensive summary that includes diagnostic assessment and analysis, endovascular versus open surgical treatment, regenerative and adjunctive therapies, and other important aspects of CLI.

Critical limb ischemia (CLI) continues to be a major cause of vascular-related morbidity and mortality in the United States.The study sought to characterize the trends in hospitalization of U.S. patients with CLI from 2003 to 2011, using the Nationwide Inpatient Sample. We compared the cost utilization and in-hospital outcomes of endovascular and surgical revascularization procedures for CLI.CLI and revascularization procedures were identified using International Classification of Diseases-Ninth Edition-Clinical Modification codes. In-hospital mortality and amputation were coprimary outcomes. Length of stay (LOS) and cost of hospitalization were secondary outcomes.We included a total of 642,433 admissions with CLI across 2003 to 2011. The annual rate of CLI admissions has been relatively constant across 2003 to 2011 (∼150 per 100,000 people in the United States). There has been a significant reduction in the proportion of patients undergoing surgical revascularization from 13.9% in 2003 to 8.8% in 2011, while endovascular revascularization has increased from 5.1% to 11.0% during the same time period. This was accompanied by a steady reduction in the incidence of in-hospital mortality and major amputation. Compared to surgical revascularization, endovascular revascularization was associated with reduced in-hospital mortality (2.34% vs. 2.73%, p 0.001), mean LOS (8.7 days vs. 10.7 days, p0.001), and mean cost of hospitalization ($31,679 vs. $32,485, p 0.001) despite similar rates of major amputation (6.5% vs. 5.7%, p = 0.75).While CLI admission rates have remained constant from 2003 to 2011, rates of surgical revascularization have significantly declined and endovascular revascularization procedures have increased. This has been associated with decreasing rates of in-hospital death and major amputation rates in the United States. Despite multiple adjustments, endovascular revascularization was associated with reduced in-hospital mortality compared to surgical revascularization during 2003 to 2011.

Peripheral artery disease (PAD) is associated with increased mortality and concomitant coronary artery disease (CAD). However, it is unclear whether uncovering the presence of functional coronary ischemia by single-photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) would further help stratifying that excess risk. From January 2000 to 2009, 4294 individuals underwent cardiac stress testing within 180 days of ankle–brachial index (ABI) measurements. Of these, 645 had PAD and SPECT MPI stress testing. Abnormal ABI was defined as ⩽0.9 or prior lower extremity arterial revascularization. Myocardial ischemic burden and total jeopardized myocardium were represented by the summed difference score (SDS) and summed stress score (SSS), respectively. Univariate and multivariable Cox proportional hazard analyses were used to study the impact of SDS and SSS on all-cause mortality. Additionally, using a hierarchical approach, we examined the step-wise addition of post-stress test coronary and lower extremity arterial revascularizations as time-varying covariates on outcomes. We found no significant difference in all-cause mortality between patients with ischemic myocardium (SDS>0) and those without (SDS=0) (adjusted HR: 0.94, 95% CI: 0.53–1.69; p=0.84). Similarly, the presence of jeopardized myocardium (SSS>0) did not have a significant impact on mortality (adjusted HR: 1.16, 95% CI: 0.67–2.00; p=0.59). Moreover, adjustment for post-testing coronary and lower extremity arterial revascularizations did not affect our results. In conclusion, ischemic and jeopardized myocardia are not predictors of all-cause mortality in PAD; thus, SPECT MPI does not appear to be a useful risk stratification tool in these patients.

Chronic critical limb ischemia occurs in the setting of severe peripheral arterial disease that is often characterized by advanced atherosclerosis at multiple levels in the lower extremity. Despite the challenges posed by the complexity of arterial disease in such patients, endovascular intervention is a less invasive alternative to infrainguinal bypass graft surgery in most patients, with low procedural morbidity and mortality. Continual advances in percutaneous techniques have made it possible to revascularize lesions considered nonamenable for endovascular intervention. For example, the development of dedicated peripheral wires, balloons, stents, and catheters allows the recanalization and revascularization of almost any anatomy. Pharmaceutical advances in risk factor modification for recurrent stenosis impact results. Such evolution makes data comparison difficult. This review aims to present the available data on endovascular therapy in critical limb ischemia patients reported over the past 2 decades.

Aims Our aim was to report techniques and outcomes of our experience in percutaneous stenting of ostial common carotid artery lesions. Methods and results We retrospectively reviewed patient medical records at our institution from January 2005 until April 2011 to determine baseline characteristics, procedural details and follow-up data of patients who underwent percutaneous stenting of ostial lesions of the common carotid artery. Our study included 17 patients of whom eight (47%) were male. Sixteen of the 17 (94.1%) procedures were performed in left common carotid arteries. In seven recent patients we used a standardised technique, which was characterised by crossing the lesion with a 0.014" wire, followed by insertion of an embolic protection device with a 300 cm long wire. In this technique, the stent mounted on a 0.035" balloon catheter was deployed on both wires instead of only on the embolic protection device wire. Mean follow-up was 17.6 months. During the follow-up, only one patient had a transient ischaemic attack, and none of them had either stroke, ischaemic retinal event, myocardial infarction or contrast nephropathy. Death was observed in five patients at the end of the study period. Conclusions Stenting of ostial lesions of the common carotid artery appears safe and effective.