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Multidisciplinary pulmonary embolism response teams (PERTs) are being implemented to improve care of patients with life-threatening PE. We sought to determine how the creation of PERT affects treatment and outcomes of patients with serious PE. A pre- and post-intervention study was performed using an interrupted time series design, to compare patients with PE before (2006-2012) and after (2012-2016) implementation of PERT at a university hospital. T-tests, Chi square tests and logistic regression were used to compare outcomes, and multivariable regression were used to adjust for differences in PE severity. Two-sided p-value < 0.05 was considered significant. For the interrupted time-series analysis, data was divided into mutually exclusive 6-month time periods (11 pre- and 7 post-PERT). To examine changes in treatment and outcomes associated with PERT, slopes and change points were compared pre- and post-PERT. Two-hundred and twelve pre-PERT and 228 post-PERT patients were analyzed. Patient demographics were generally similar, though pre-PERT, PE were more likely to be low-risk (37% vs. 19%) while post-PERT, PE were more likely to be submassive (32% vs. 49%). More patients underwent catheter directed therapy (1% vs. 14%, p = < 0.0001) or any advanced therapy (19 [9%] vs. 44 [19%], p = 0.002) post PERT. Interrupted time series analysis demonstrated that this increase was sudden and coincident with implementation of PERT, and most noticeable among patients with submassive PE. There were no differences in major bleeding or mortality pre- and post-PERT. While the use of advanced therapies, particularly catheter-directed therapies, increased after creation of PERT, especially among patients with submassive PE, there was no apparent increase in bleeding.

Background: Extracorporeal membrane oxygenation (ECMO) has been used to stabilize patients with massive pulmonary embolism though few reports describe this approach. We describe the presentation, management and outcomes of patients who received ECMO for massive pulmonary embolism (PE) in our pulmonary embolism response team (PERT) registry., Methods: We enrolled a consecutive cohort of patients with confirmed PE for whom PERT was activated and selected patients treated with ECMO. We prospectively captured clinical, therapeutic and outcome data at the time of PERT activation and during the follow-up period for up to 365 days., Results: Thirteen patients who had PERT activation with confirmed PE diagnosis have undergone ECMO since the initiation of our PERT program in 2012. The mean age was 49 ± 19 years. Six (46%) patients were female. All the patients had cardiac arrest, either as an initial presentation or in-hospital cardiac arrest after presentation. All the patients exhibited right ventricular (RV) dilation on echocardiogram with RV hypokinesis. Eight (62%) patients received systemic thrombolysis with intravenous tissue plasminogen activator (tPA) and three (23%) patients underwent catheter-directed thrombolysis therapy using the EKOS system (EKOS Corporation, Bothell, WA, USA). Four (31%) patients underwent surgical embolectomy. Mean ECMO duration was 5.5 days, ranging from 2-18 days. Thirty-day mortality was 31% and one-year mortality was 54%., Conclusions: Patients with massive pulmonary embolism who suffer a cardiac arrest have high morbidity and mortality. ECMO can be used in conjunction with systemic thrombolysis, catheter-directed therapy or as a bridge to surgical embolectomy.

Pulmonary embolism (PE) is a life-threatening condition and a leading cause of morbidity and mortality. There have been many advances in the field of PE in the last few years, requiring a careful assessment of their impact on patient care. However, variations in recommendations by different clinical guidelines, as well as lack of robust clinical trials, make clinical decisions challenging. The Pulmonary Embolism Response Team Consortium is an international association created to advance the diagnosis, treatment, and outcomes of patients with PE. In this consensus practice document, we provide a comprehensive review of the diagnosis, treatment, and follow-up of acute PE, including both clinical data and consensus opinion to provide guidance for clinicians caring for these patients.

Background: Few contemporary studies have assessed the management and outcomes of patients with massive and submassive pulmonary embolism. Given advances in therapy, we report contemporary practice patterns and event rates among these patients., Methods: We analyzed a prospective database of patients with massive and submassive pulmonary embolism. We report clinical characteristics, therapies, and outcomes stratified by pulmonary embolism type. Treatment escalation beyond systemic anticoagulation was defined as advanced therapy. Cox proportional hazards regression was used to identify predictors of 90-day mortality., Results: Among 338 patients, 46 (13.6%) presented with massive and 292 (86.4%) with submassive pulmonary embolism. The average age was 63 ± 15 years, 49.9% were female, 32.0% had malignancy, and 21.9% had recent surgery. Massive pulmonary embolism patients received advanced therapy in 71.7% (30.4% systemic thrombolysis, 17.4% catheter-directed thrombolysis, 15.2% surgical embolectomy) and had greater 90-day mortality rates compared with submassive pulmonary embolism patients (41.3% vs 12.3%, respectively; P < .01). Most massive pulmonary embolism deaths (78.9%) occurred in-hospital, whereas mortality risk persisted after discharge for submassive pulmonary embolism. After multivariable adjustment, massive pulmonary embolism was associated with a 5.23-fold greater hazard of mortality (95% confidence interval, 2.70-10.13; P < .01). Advanced therapies among all pulmonary embolism patients were associated with a 61% reduction in mortality (95% confidence interval, 0.20-0.76; P < .01)., Conclusions: Among contemporary massive and submassive pulmonary embolism patients, mortality remains substantial. Advanced therapies were frequently utilized and independently associated with lower mortality. Further investigation is needed to determine how to improve outcomes among these high-risk patients, including the optimal use of advanced therapies., (Copyright © 2018. Published by Elsevier Inc.)

There are no dedicated data to guide drug-eluting stent (DES) versus bare-metal stent (BMS) selection in patients with end-stage renal disease undergoing dialysis (ESRD-D). It is unclear whether long-term benefits of a specific stent type outweigh risks in this population at high risk for both bleeding and ischemic events. We performed a meta-analysis of nonrandomized studies extracted from PubMed, Scopus, and EMBASE, assessing the safety and effectiveness of DES versus BMS in ESRD-D patients. Odds ratios (OR) and 95% confidence intervals (CI) were computed with the Mantel-Haenszel method. Random-effects model was used for all analyses. A total of 17 nonrandomized studies (N = 63,157; 41,621 DES and 21,536 BMS) met the inclusion criteria and were included for the final quantitative analysis: median follow-up of 1 year (range: 9 months to 6 years). The use of DES in ESRD-D patients was associated with lower all-cause mortality (OR 0.75, 95% CI 0.64-0.89, P < 0.001) compared with BMS. The use of DES was also associated with lower rates of cardiovascular mortality (OR 0.75, 95% CI 0.60-0.99, P = 0.047) and target lesion/vessel revascularization (OR 0.78, 95% CI 0.64-0.94, P = 0.01). However, there were no differences in noncardiovascular mortality, myocardial infarction, stent thrombosis, stroke, or major bleeding in DES versus BMS. In this largest meta-analysis of long-term outcomes after percutaneous coronary intervention in ESRD-D patients, DES was associated with lower rates of all-cause mortality, target lesion/vessel revascularization, and cardiovascular death.

Plaque modification devices are used to treat heavily calcified coronary artery lesions during percutaneous coronary artery interventions. As these devices have unique risk profiles, clinicians need to be aware of potential complications associated with their use. A case of a contained rupture (i.e., pseudoaneurysm) of the proximal left main coronary artery following orbital atherectomy is presented. This lesion was managed with coronary artery bypass grafting and oversewing of the left main coronary artery ostium. This case illustrates that lesion location and configuration may influence tracking of these devices, as well as the actual site of tissue ablation. This case underscores the importance of concurrent imaging during treatment and concern for potential unintended consequences of atherectomy., (© 2018 Wiley Periodicals, Inc.)

Pulmonary Embolism Response Teams (PERTs) are being created around the United States to immediately and simultaneously bring together multiple specialists to determine the best course of action and coordinate clinical care for patients with severe pulmonary embolism (PE). The organization and structure of each PERT will depend on local clinical demands and resources. Creating a follow up clinic for PE patients after discharge from the hospital is an essential component of any PERT program. PERT programs, which have come together to form the PERT Consortium®, are changing the landscape of PE treatment and may represent a new standard of care., (Copyright © 2018 Elsevier Inc. All rights reserved.)

For more than 10 years, the Harmonization by Doing (HBD) program, a joint effort by members from academia, industry and regulators from the United States of America (USA) and Japan, has been working to increase timely regulatory approval for cardiovascular devices through the development of practical global clinical trial paradigms. Consistent with this mission and in recognition of the increasing global public health effects of critical limb ischemia (CLI), academic and government experts from the USA and Japan have developed a basic framework of global clinical trials for endovascular devices for CLI. Despite differences in medical and regulatory environments and complex patient populations in both countries, we developed a pathway for the effective design and conduct of global CLI device studies by utilizing common study design elements such as patients' characteristics and study endpoints, and minimizing the effect of important clinical differences. Some of the key recommendations for conducting global CLI device studies are: including patients on dialysis; using a composite primary endpoint for effectiveness that includes 6-month post-procedure therapeutic success and target vessel patency; and using a 30-day primary safety endpoint of perioperative death and major adverse limb events. The proposed approach will be uniquely beneficial in facilitating both the initiation and interpretation of CLI studies and accelerating worldwide CLI device development and innovation.

Importance: Public reporting of procedural outcomes has been associated with lower rates of percutaneous coronary intervention (PCI) and worse outcomes after myocardial infarction. Contemporary data are limited on the influence of public reporting on interventional cardiologists' clinical decision making., Objective: To survey a contemporary cohort of interventional cardiologists in Massachusetts and New York about how public reporting of PCI outcomes influences clinical decision making., Design, Setting, and Participants: An online survey was developed with public reporting experts and administered electronically to eligible physicians in Massachusetts and New York who were identified by Doximity (an online physician networking site) and 2014 Medicare fee-for-service claims for PCI procedures. The personal and hospital characteristics of participants were ascertained via a comprehensive database from Doximity and the American Hospital Association annual surveys of US hospitals (2012 and 2013) and linked to survey responses. Associations between survey responses and characteristics of participants were evaluated in univariable and multivariable analyses., Main Outcomes and Measures: Reported rate of avoidance of performing PCIs in high-risk patients and of perception of pressure from colleagues to avoid performing PCIs., Results: Of the 456 physicians approached, 149 (32.7%) responded, including 67 of 129 (51.9%) in Massachusetts and 82 of 327 (25.1%) in New York. The mean (SD) age was 49 (9.2) years; 141 of 149 participants (94.6%) were men. Most participants reported practicing at medium to large, nonprofit hospitals with high-volume cardiac catheterization laboratories and cardiothoracic surgery capabilities. In 2014, participants had higher annual PCI volumes among Medicare patients than nonparticipants did (median, 31; interquartile range [IQR], 13-47 vs median, 17; IQR, 0-41; P < .001). Among participants, 65% reported avoiding PCIs on at least 2 occasions becase of concern that a bad outcome would negatively impact their publicly reported outcomes; 59% reported sometimes or often being pressured by colleagues to avoid performing PCIs because of a concern about the patient's risk of death. After multivariable adjustment, more years of experience practicing interventional cardiology was associated with lower odds of PCI avoidance. The state of practice was not associated with survey responses., Conclusions and Relevance: Current PCI public reporting programs can foster risk-averse clinical practice patterns, which do not vary significantly between interventional cardiologists in New York and Massachusetts. Coordinated efforts by policy makers, health systems leadership, and the interventional cardiology community are needed to mitigate these unintended consequences.

There is a paucity of robust clinical trial data to guide the treatment of acute pulmonary embolism (PE) thus the clinical guidelines rely heavily on expert opinion. Pulmonary Embolism Response Teams (PERT) have been developed to streamline the care of patients with acute PE. We conducted a survey among 100 experts in the field of PE during the second annual meeting of the PERT Consortium. Respondents were queried with respect to their demographic information, clinical practice questions and clinical vignettes. Clinical practice questions were focused questions about the risk stratification and treatment of patients with acute submassive PE, anticoagulation strategies for patients receiving thrombolysis and the use of inferior vena cava filters. Clinical vignettes were designed to assess participants' preferred choice of treatment for a variety of commonly encountered clinical scenarios. Among physicians affiliated with a PERT, there is overall agreement with regards to the criteria used for risk classification of patients with PE and its application to patients in the provided clinical vignettes. In contrast, there is substantial variability in the treatment strategies of patients presenting with commonly encountered clinical scenarios. The results of this survey highlight the need for more clinical trial data along with accepted algorithms for treatment of acute PE. In the absence of this, PERTs can facilitate multidisciplinary discussions in order to standardize treatment and provide evidence-based therapies to patients with acute PE.

Background: Venous thromboembolism (VTE) is the third leading cause of vascular disease and accounts for $10 billion in annual US healthcare costs. The nationwide burden of 30-day readmissions after such events has not been comprehensively assessed., Methods and Results: We analyzed adults ≥18 years of age with hospitalizations associated with acute VTE between January 1, 2010, and December 31, 2014, in the Nationwide Readmissions Database. International Classification of Disease, Ninth Revision, Clinical Modification ( ICD-9- CM ) codes were used to identify hospitalizations associated with acute pulmonary embolism or deep vein thrombosis. The primary outcome was the rate of unplanned 30-day readmission. Hierarchical logistic regression was used to calculate hospital-specific 30-day risk-standardized readmission rates, a marker of healthcare quality. Among 1 176 335 hospitalizations with acute VTE, in-hospital death occurred in 6.2%. VTE was associated with malignancy in 19.7%, recent surgery in 19.3%, recent trauma in 4.6%, hypercoagulability in 3.3%, and pregnancy in 1.0%. Among survivors to discharge, the 30-day readmission rate was 17.5%, with no significant difference in rates across study years (17.4%-17.7%; P =0.10 for trend). Major predictors of readmission were malignancy (relative risk, 1.49, 95% confidence interval 1.47-1.50), Medicaid insurance (relative risk, 1.48, 95% confidence interval 1.46-1.50), and nonelective index admission (relative risk, 1.31, 95% confidence interval 1.29-1.33). Top causes of readmission included sepsis (9.6%) and procedural complications (8.1%). Median rehospitalization costs were $9781.7 (interquartile range, $5430.7-$18 784.1), and 8.1% died during readmission. The interquartile range in risk-standardized readmission rates was 16.6% to 18.3%, suggesting modest interhospital heterogeneity in readmission risk., Conclusions: Nearly 1 in 5 patients with acute VTE were readmitted within 30 days. Predictors and causes of readmission were primarily related to patient characteristics and complications from comorbid conditions, whereas healthcare quality had a moderate impact on readmission risk., (© 2018 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.)

The burden and impact of sleep deprivation on both patient care and on the health of interventional cardiologists is not well understood. Due to the nature of emergent procedures occurring in the cardiac catheterization laboratory, interventionalists are prone to suffer from acute and/or chronic sleep deprivation. Sleep deprivation has been associated with numerous adverse effects, such as impaired performance, cognitive deficits, reduced psychomotor vigilance, and workplace errors and injuries, among many others. Although sleep deprivation has been linked to more errors in trainees, there is paucity of data addressing outcomes in interventional cardiology. The purpose of this overview is to explore the possible impact of sleep deprivation on interventional cardiology in relation to patient care and physician health, and examine potential approaches to this issue., (© 2017 Wiley Periodicals, Inc.)

This publication describes uniform definitions for cardiovascular and stroke outcomes developed by the Standardized Data Collection for Cardiovascular Trials Initiative and the U.S. Food and Drug Administration (FDA). The FDA established the Standardized Data Collection for Cardiovascular Trials Initiative in 2009 to simplify the design and conduct of clinical trials intended to support marketing applications. The writing committee recognizes that these definitions may be used in other types of clinical trials and clinical care processes where appropriate. Use of these definitions at the FDA has enhanced the ability to aggregate data within and across medical product development programs, conduct meta-analyses to evaluate cardiovascular safety, integrate data from multiple trials, and compare effectiveness of drugs and devices. Further study is needed to determine whether prospective data collection using these common definitions improves the design, conduct, and interpretability of the results of clinical trials., (Copyright © 2018 American College of Cardiology Foundation and American Heart Association, Inc. Published by Elsevier Inc. All rights reserved.)

Objective: To examine the relationship between occupational exposure to ionizing radiation and the prevalence of lens changes in interventional cardiologists (ICs) and catheterization laboratory ("cath-lab") staff., Background: Exposure to ionizing radiation is associated with the development of lens opacities. ICs and cath-lab staff can receive high doses of ionizing radiation without protection, and may thus be at risk for lens opacity formation., Methods: We conducted a cross-sectional study at an interventional cardiology conference. Study participants completed a questionnaire pertaining to occupational exposure to radiation and potential confounders for the development of cataracts, followed by slit-lamp examination and grading of lens findings., Results: A total of 117 attendees participated in the study, including 99 (85%; 49 ± 11 years-old; 82% male) with occupational exposure to ionizing radiation and 18 (15%; 39 ± 12 years-old; 61% male) unexposed controls. The prevalence of overall cortical and posterior subcapsular lens changes (including subclinical findings) was higher in exposed participants compared with controls (47 vs. 17%, P = 0.015). Occupational exposure and age over 60 were independent predictors of lens changes (odds ratio [95% CI]: 6.07 [1.38-43.45] and 7.72 [1.60-43.34], respectively). The prevalence of frank opacities was low and similar between the two groups (14 vs. 6%, P = 0.461). Most lens findings consisted of subclinical changes in the periphery of the lens without impact on visual acuity., Conclusions: Compared with unexposed controls, ICs and cath-lab staff had a higher prevalence of lens changes that may be attributable to ionizing radiation exposure. While most of these changes were subclinical, they are important due to the potential to progress to clinical symptoms, highlighting the importance of minimizing staff radiation exposure., (© 2017 Wiley Periodicals, Inc.)

Mortality associated with high-risk pulmonary embolism (PE) remains high. Extra-corporeal membrane oxygenation (ECMO) allows for acute hemodynamic stabilization and potentially for administration of other disease process altering therapies. We sought to compare two eras: pre-ECMO and post-ECMO in relation to high-risk PE treatment and mortality. A single-center retrospective chart review was conducted of high-risk PE patients. High-risk PE was defined as acute PE and cardiac arrest or shock. A total of 60 patients were identified, 31 in the pre-ECMO era and 29 in the post-ECMO era. Mean age was 56.1±21.1 years and 51.7% were women. More patients in the post-ECMO era were identified with computed tomography (82.8% vs 51.6%, p=0.011) and more patients in the post-ECMO era had right ventricular dysfunction on echocardiography (96.4% vs 78.3%, p=0.045). No other differences were noted in baseline characteristics or clinical, laboratory and imaging data between the two groups. In total, ECMO was used in 13 (44.8%) patients in the post-ECMO era. There was greater utilization of catheter-directed therapies in the post-ECMO era compared to the pre-ECMO era ( n = 7 (24.1%) vs n = 1 (3.2%), p=0.024). Thirty-day survival increased from 17.2% in patients who presented in the pre-ECMO era to 41.4% in the post-ECMO era ( p=0.043). While more work is necessary to better identify those PE patients who stand to benefit from mechanical circulatory support, our findings have important implications for the management of such patients.

Background: The impact of carotid artery stent fractures on the incidence of adverse clinical events remains unclear. The objective of this study is to report the stent fracture rate and its association with in-stent restenosis and adverse outcomes in the ACT-1 trial (Carotid Angioplasty and Stenting Versus Endarterectomy in Asymptomatic Subjects Who Are at Standard Risk for Carotid Endarterectomy With Significant Extracranial Carotid Stenotic Disease)., Methods: ACT-1 is a prospective multicenter trial of patients who have standard surgical risk with severe asymptomatic carotid artery stenosis randomly assigned to carotid artery stenting or carotid endarterectomy (Abbott Vascular). The primary end point was a composite of death, stroke, or myocardial infarction during the 30 days after the procedure or ipsilateral stroke during the 365 days after the procedure. After 771 patients were enrolled, successively randomly assigned patients were required to undergo annual radiographic (x-ray) analysis for stent fracture. Images were independently adjudicated by a core laboratory., Results: Of 1021 patients treated with carotid artery stenting during a mean follow-up of 3.1±1.6 years, 939 had at least 1 x-ray during the follow-up period. Stent fracture was reported in 51 (5.4%) patients. With a maximum follow-up period of 5 years, adverse clinical outcomes occurred in 39 patients with at least 1 x-ray during the follow-up. Of 826 (80.9%) subjects who underwent both duplex ultrasound and x-ray, 822 (99.5%) were interpretable. There was no association between stent fracture and the primary end point ( P =0.86) or with restenosis ( P =0.53)., Conclusions: In this large, independently adjudicated, multicenter study, the stent fracture rate was low and not associated with major adverse clinical events or in-stent restenosis., Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT00106938., (© 2017 American Heart Association, Inc.)

Purpose of Review: This review paper provides a summary on the use of drug-coated balloons in peripheral artery disease. It covers the main drug-coated balloon (DCB) trials. It is divided into categories of lesions: superficial femoral artery and popliteal lesions, infra-popliteal lesions and in-stent restenosis. It also includes an overview of the future of DCBs, highlighting the main ongoing trials., Recent Findings: The latest research on DCB focuses on newer types of DCBs, mainly paclitaxel-coated but with lower doses. Another area of latest DCB research is its use in superficial femoral artery and popliteal artery in-stent restenosis, with superior outcomes. Drug-coated balloons produce better outcomes than percutaneous transluminal angioplasty alone in de novo and in-stent restenosis lesions of superficial femoral artery and popliteal arteries. More data are needed to demonstrate efficacy and safety of DCBs in infrapopliteal disease. Newer DCBs and adjunctive therapy may provide improved outcomes for peripheral artery disease interventions.

Objectives: Pulmonary embolism response teams (PERT) are developing rapidly to operationalize multi-disciplinary care for acute pulmonary embolism patients. Our objective is to describe the core components of PERT necessary for newly developing programs., Methods: An online organizational survey of active National PERT™ Consortium members was performed between April and June 2016. Analysis, including descriptive statistics and Kruskal-Wallis tests, was performed on centers self-reporting a fully operational PERT program., Results: The survey response rate was 80%. Of the 31 institutions that responded (71% academic), 19 had fully functioning PERT programs. These programs were run by steering committees (17/19, 89%) more often than individual physicians (2/19, 11%). Most PERT programs involved 3-5 different specialties (14/19, 74%), which did not vary based on hospital size or academic affiliation. Of programs using multidisciplinary discussions, these occurred via phone or conference call (12/18, 67%), with a minority of these utilizing 'virtual meeting' software (2/12, 17%). Guidelines for appropriate activations were provided at 16/19 (84%) hospitals. Most PERT programs offered around-the-clock catheter-based or surgical care (17/19, 89%). Outpatient follow up usually occurred in personal physician clinics (15/19, 79%) or dedicated PERT clinics (9/19, 47%), which were only available at academic institutions., Conclusions: PERT programs can be implemented, with similar structures, at small and large, community and academic medical centers. While all PERT programs incorporate team-based multi-disciplinary care into their core structure, several different models exist with varying personnel and resource utilization. Understanding how different PERT programs impact clinical care remains to be investigated.

Objectives: The development of pulmonary embolism response teams (PERTs) has been widely adopted nationally with the goal of providing multidisciplinary care to patients with high-risk PE. Most PERT activations originate from the emergency department (ED), while others are from the intensive care unit (ICU) or inpatient floors. It is unclear if ED PERT activations differ from non-ED PERT activation in terms of presentation, management, and outcome., Methods: We enrolled a consecutive cohort of patients for whom PERT was activated at an urban academic medical center. We compared three groups of PERT activations based on whether the activation originated from the ED, ICU, or a non-ICU inpatient floor. We compared these groups in terms of the proportion of PERT activations that occurred during day, evening, or weekend hours and the proportion of confirmed PE. We also compared PE severity, treatment, and outcomes across locations. We tested differences using chi-square tests, with a two-tailed p-value of <0.05 considered statistically significant., Results: We enrolled 561 patients, of whom 449 (79.5%) had confirmed PE. The mean ± SD age of patients with confirmed PE was 61 ± 17 years, and 300 (53.5%) were male. Activations from the ED (n = 283, 88.4%) or floor (n = 100, 74.6%) were more likely to be for confirmed PE than activations from the ICU (n = 63, 58.9%; p < 0.0001). There was a statistical difference in the time of day of PERT activation with the ED having more activations during night hours than the ICU or floors (p = 0.004). Most activations for confirmed, massive PE originated from the ICU (n = 41, 65.1%), followed by the ED (n = 82, 29%) and inpatient floors (n = 22, 22%; p < 0.0001). Most activations from the ED (n = 155, 54.8%) and floors (n = 55, 55%) were for submassive PE. The use of thrombolysis or thrombectomy was more common among ICU patients (n = 18, 33.3%), followed by ED patients (n = 53, 19.6%) and then floor patients (n = 8, 8.2%). Mortality and major bleeding events were most common among ICU patients and similar among ED and floor patients., Conclusions: Pulmonary embolism response team activations from different clinical locations differ in terms of patient presentation, PE confirmation, treatments, and outcomes. PERTs should be customized to support the different needs of each clinical area., (© 2017 by the Society for Academic Emergency Medicine.)

Introduction: Acute pulmonary embolism (PE) is a common cardiovascular condition resulting in significant morbidity and mortality. Consensus recommendations suggest risk stratification of patients into three main categories: high-risk or 'massive' PE, intermediate-risk or 'submassive' PE, and low-risk PE. Given the relative dearth of prospective, randomized clinical trials delineating optimal selection of the diverse medical, interventional, and surgical treatment approaches, clinical care requires a multidisciplinary expert approach to patients with PE. Areas covered: The Massachusetts General Hospital (MGH) Pulmonary Embolism Response Team (PERT) was the first of its kind to create a multidisciplinary, rapid response team for acute PE, integrated within a research and educational framework. The MGH PERT has treated more than 700 patients with PE, the majority of which are in the 'massive' or 'submassive' categories. The PERT Consortium™ was founded in 2015 as a collaborative network between the growing number of PERT programs internationally, with greater than 80 institutions participating within one year of establishment. Expert commentary: Since its advent, the PERT model has expanded throughout the United States and internationally through a collaborative institutional and research network. PERT may represent a new standard for the care of patients with acute PE.

Background: Data conflict regarding the relative effectiveness of carotid artery stenting (CAS) and carotid artery endarterectomy (CEA) for the prevention of stroke due to carotid artery stenosis., Objectives: The authors performed an updated meta-analysis evaluating the efficacy and safety of CAS versus CEA, given recently published clinical trial data., Methods: Databases were searched through April 30, 2016. Randomized trials with ≥50 patients, that had exclusive use of embolic-protection devices, and that compared CAS against CEA for the treatment of carotid artery stenosis were selected. We calculated summary odds ratios (ORs) and 95% confidence intervals (CIs) using a random-effects model., Results: We analyzed 6,526 patients from 5 trials with a mean follow-up of 5.3 years. The composite outcome of periprocedural death, stroke, myocardial infarction (MI), or nonperiprocedural ipsilateral stroke was not significantly different between therapies (OR: 1.22; 95% CI: 0.94 to 1.59). The risk of any periprocedural stroke plus nonperiprocedural ipsilateral stroke was higher with CAS (OR: 1.50; 95% CI: 1.22 to 1.84). The risk of higher stroke with CAS was mostly attributed to periprocedural minor stroke (OR: 2.43; 95% CI: 1.71 to 3.46). CAS was associated with significantly lower risk of periprocedural MI (OR: 0.45; 95% CI: 0.27 to 0.75); cranial nerve palsy (OR: 0.07; 95% CI: 0.04 to 0.14); and the composite outcome of death, stroke, MI, or cranial nerve palsy during the periprocedural period (OR: 0.75; 95% CI: 0.60 to 0.93)., Conclusions: CAS and CEA were associated with similar rates of a composite of periprocedural death, stroke, MI, or nonperiprocedural ipsilateral stroke. The risk of long-term overall stroke was significantly higher with CAS, and was mostly attributed to periprocedural minor stroke. CAS was associated with lower rates of periprocedural MI and cranial nerve palsy than CEA., (Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Pulmonary embolism (PE) is common and management is based on risk stratification. The significance of clot location in submassive and massive PE is unclear. Data from a prospectively gathered database of submassive and massive PE were used for analysis. Available data included patient presentation, diagnostics, treatment, and outcome. Comparisons were made according to clot location: central or peripheral. A multivariable model was used for composite outcome of death or right ventricular (RV) strain at 90 days. Among 269 patients, there were no significant demographic differences between patients with peripheral and central PE. Peripheral PE was more likely to present with hypotension (46.4% vs 32.6%; p = 0.02), but central PE was more likely to have RV strain on echocardiography (76.7% vs 57.7%, p <0.001) and computed tomography (58.1% vs 32.0%, p <0.0001). Peripheral PE was more likely to receive anticoagulation as the only form of therapy (69.1% vs 55.8%; p = 0.03), and central PE was more likely to receive catheter-directed therapies (18.3% vs 3.3%; p <0.001). Nonetheless, peripheral PE had higher 30- and 90-day all-cause mortality (18.5% vs 9.3%; p = 0.03; 25.9% vs 13.5%; p = 0.02, respectively). In a multivariable analysis, the only independent predictor of death or RV strain at 90 days was increased age (odds radio 1.35, CI 1.06 to 1.72 per 10 years). Specifically, neither clot location nor treatment was associated with patient outcomes. In conclusion, in this cohort of patients with submassive and massive PE, clot location was associated with treatment patterns but not patient outcomes to 90 days. Reevaluation of practice is thus warranted., (Copyright © 2016 Elsevier Inc. All rights reserved.)

Pulmonary embolism (PE) is a serious and prevalent cause of vascular disease. Nevertheless, optimal treatment for many phenotypes of PE remains uncertain. Treating PE requires appropriate risk stratification as a first step. For the highest-risk PE, presenting as shock or arrest, emergent systemic thrombolysis or embolectomy is reasonable, while for low-risk PE, anticoagulation alone is often chosen. Normotensive patients with PE but with indicia of right heart dysfunction (by biomarkers or imaging) constitute an intermediate-risk group for whom there is controversy on therapeutic strategy. Some intermediate-risk patients with PE may require urgent stabilization, and ≈10% will decompensate hemodynamically and suffer high mortality, though identifying these specific patients remains challenging. Systemic thrombolysis is a consideration, but its risks of major and intracranial hemorrhages rival overall harms from intermediate PE. Multiple hybrid pharmacomechanical approaches have been devised to capture the benefits of thrombolysis while reducing its risks, but there is limited aggregate clinical experience with such novel interventional strategies. One method to counteract uncertainty and generate a consensus multidisciplinary prognostic and therapeutic plan is through a Pulmonary Embolism Response Team, which combines expertise from interventional cardiology, interventional radiology, cardiac surgery, cardiac imaging, and critical care. Such a team can help determine which intervention-catheter-directed fibrinolysis, ultrasound-assisted thrombolysis, percutaneous mechanical thrombus fragmentation, or percutaneous or surgical embolectomy-is best suited to a particular patient. This article reviews these various modalities and the background for each., (© 2017 American Heart Association, Inc.)

Pulmonary embolism (PE) is a complex diagnosis that encompasses a wide range of clinical presentations. Often patients who present with PE have complicated medical histories which can make their management challenging. Many novel therapeutic strategies and tools are emerging to improve the care and outcomes of patients with PE. Pulmonary embolism response teams (PERTs) are developing at multiple centers to improve the decision making, efficiency and orchestration of these clinical strategies. Concordantly with development of PERT programs is the design and implementation of systems to allow for numerous specialists to convene and discuss complex PE patients in real time. The mechanisms to engage a multidisciplinary approach are proving to be an invaluable resource in the decision making processes and treatment of high risk PE patients. Ultimately, other multi-disciplinary teams may adopt these methods to better address their clinical needs., Competing Interests: Kenneth Rosenfield discloses the following relationships. Consultant: Cardinal Health, SurModics. Grants/Contracts: Abbott Vascular, Atrium, Lutonix/BARD, The Medicines Company. Equity: Access Closure, Inc., AngioDynamics/Vortex. Personal Compensation: Cook, HCRI, The Medicines Company. Board Member: VIVA Physicians. The other authors have no conflicts of interest to declare.

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., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Background: Integrating newly developed tests and treatments for severe pulmonary embolism (PE) into clinical care requires coordinated multispecialty collaboration. To meet this need, we developed a new paradigm: a multidisciplinary Pulmonary Embolism Response Team (PERT). In this report, we provide the first longitudinal analysis of patients treated by a PERT., Methods: Our PERT includes specialists in cardiovascular medicine and surgery, emergency medicine, hematology, pulmonary/critical care, and radiology, and is organized as a rapid response team. We prospectively captured clinical, therapeutic, and outcome data at PERT activation and during follow-up periods up to 365 days. We analyzed data collectively, and as five mutually exclusive 6-month periods. We performed Fisher exact tests and regression analysis to test for trend., Results: In 30 months, there were 394 unique PERT activations, 314 (80%) for confirmed PE. PERT activations increased by 16% every 6 months. Most confirmed PEs were submassive (n = 143, 46%) or massive (n = 80, 26%). The PERT treated a relatively large proportion of patients with PE and systemic or catheter-directed thrombolysis (n = 35, 11%), though the most common treatment was anticoagulation alone (n = 215, 69%). Hemorrhagic complications were rare overall, especially among patients treated with catheter-directed thrombolysis. The all-cause 30-day mortality of PERT patients with confirmed PE was 12%., Conclusions: We report our initial 30-month experience with a novel multidisciplinary PERT that rapidly engages multiple specialists to deliver efficient, organized, and evidence-based care to patients with high-risk PE. The PERT paradigm was rapidly adopted and may become a new standard of care for patients with PE., (Copyright © 2016 American College of Chest Physicians. Published by Elsevier Inc. All rights reserved.)

Background: Critical limb ischemia (CLI) is increasing in prevalence, and remains a significant source of mortality and limb loss. The decision to recommend surgical or endovascular revascularization for patients who are candidates for both varies significantly among providers and is driven more by individual preference than scientific evidence., Methods and Results: The Best Endovascular Versus Best Surgical Therapy for Patients With Critical Limb Ischemia (BEST-CLI) Trial is a prospective, randomized, multidisciplinary, controlled, superiority trial designed to compare treatment efficacy, functional outcomes, quality of life, and cost in patients undergoing best endovascular or best open surgical revascularization. Approximately 140 clinical sites in the United States and Canada will enroll 2100 patients with CLI who are candidates for both treatment options. A pragmatic trial design requires consensus on patient eligibility by at least 2 investigators, but leaves the choice of specific procedural strategy within the assigned revascularization approach to the individual treating investigator. Patients with suitable single-segment of saphenous vein available for potential bypass will be randomized within Cohort 1 (n=1620), while patients without will be randomized within Cohort 2 (n=480). The primary efficacy end point of the trial is Major Adverse Limb Event-Free Survival. Key secondary end points include Re-intervention and Amputation-Free-Survival and Amputation Free-Survival., Conclusions: The BEST-CLI trial is the first randomized controlled trial comparing endovascular therapy to open surgical bypass in patients with CLI to be carried out in North America. This landmark comparative effectiveness trial aims to provide Level I data to clarify the appropriate role for both treatment strategies and help define an evidence-based standard of care for this challenging patient population., Clinical Trial Registration: URL: https://www.clinicaltrials.gov/. Unique identifier: NCT02060630., (© 2016 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.)

Purpose: To report a subanalysis of the German centers enrolling patients in the prospective, global, multicenter, randomized LEVANT 2 pivotal trial (ClinicalTrials.gov identifier NCT01412541) of the Lutonix drug-coated balloon (DCB) for the treatment of femoropopliteal occlusive disease., Methods: Among the 476 patients in LEVANT 2, 126 patients (mean age 67.1±9.6 years; 79 men) were enrolled at the 8 participating German sites between August 2011 and July 2012 and were randomized 2:1 to treatment with the Lutonix DCB (n=83) vs an uncoated balloon during percutaneous transluminal angioplasty (PTA, n=43). All patients had intermittent claudication or rest pain (Rutherford categories 2-4). Average lesion length was 58 mm and average treated length was 100 mm. Severe calcification was present in 11% of lesions, and 23% were total occlusions. The efficacy outcome was primary patency at 12 months, and the safety outcome was 12-month freedom from a composite of perioperative death, index limb-related death, amputation (below or above the ankle), and index limb revascularization. Secondary endpoints included target lesion revascularization (TLR), major adverse events, and functional outcomes., Results: Demographic, clinical, and lesion characteristics were matched between Lutonix DCB and PTA groups, as were the final percent diameter stenosis (19%) and procedure success (91%). By Kaplan-Meier analysis, the 12-month primary patency rate was 80% vs 58% (p=0.015) and the composite safety endpoint rate was 94% vs 72% (p=0.001), respectively. Freedom from TLR was higher for DCBs (96%) vs PTA (82%, p=0.012). Major adverse events were similar for both groups. The benefit favoring DCB over PTA was observed in German men and women. Compared to the non-German LEVANT 2 cohort, there was a shorter time between insertion and inflation of treatment balloons (21.8 vs 39.5 seconds, p<0.001) in the German cohort. Balloons were inflated to higher pressures (9.0 vs 7.7 atm, p<0.001) but for a shorter period of time (130 vs 167 seconds, p<0.001), and although treated lesions in the German cohort had a higher baseline stenosis, final postprocedure diameter stenosis was lower (19% vs 22%, p=0.04) than in the non-German patients., Conclusion: Superiority of DCB over PTA in the German cohort of LEVANT 2 was demonstrated for primary patency, composite safety, and freedom from TLR. The benefit of DCB was also consistent for both genders. Geographic or regional differences in procedural variables may account for the different outcomes between the German and non-German cohorts., (© The Author(s) 2016.)

Background: Previous clinical trials have suggested that carotid-artery stenting with a device to capture and remove emboli ("embolic protection") is an effective alternative to carotid endarterectomy in patients at average or high risk for surgical complications., Methods: In this trial, we compared carotid-artery stenting with embolic protection and carotid endarterectomy in patients 79 years of age or younger who had severe carotid stenosis and were asymptomatic (i.e., had not had a stroke, transient ischemic attack, or amaurosis fugax in the 180 days before enrollment) and were not considered to be at high risk for surgical complications. The trial was designed to enroll 1658 patients but was halted early, after 1453 patients underwent randomization, because of slow enrollment. Patients were followed for up to 5 years. The primary composite end point of death, stroke, or myocardial infarction within 30 days after the procedure or ipsilateral stroke within 1 year was tested at a noninferiority margin of 3 percentage points., Results: Stenting was noninferior to endarterectomy with regard to the primary composite end point (event rate, 3.8% and 3.4%, respectively; P=0.01 for noninferiority). The rate of stroke or death within 30 days was 2.9% in the stenting group and 1.7% in the endarterectomy group (P=0.33). From 30 days to 5 years after the procedure, the rate of freedom from ipsilateral stroke was 97.8% in the stenting group and 97.3% in the endarterectomy group (P=0.51), and the overall survival rates were 87.1% and 89.4%, respectively (P=0.21). The cumulative 5-year rate of stroke-free survival was 93.1% in the stenting group and 94.7% in the endarterectomy group (P=0.44)., Conclusions: In this trial involving asymptomatic patients with severe carotid stenosis who were not at high risk for surgical complications, stenting was noninferior to endarterectomy with regard to the rate of the primary composite end point at 1 year. In analyses that included up to 5 years of follow-up, there were no significant differences between the study groups in the rates of non-procedure-related stroke, all stroke, and survival. (Funded by Abbott Vascular; ACT I ClinicalTrials.gov number, NCT00106938.).

Compared with recent advances in treatment of serious cardiovascular diseases, such as myocardial infarction and stroke, the treatment and outcome of acute pulmonary embolism (PE) have remained relatively unchanged over the last few decades. This has prompted several experts to call for the formation of multidisciplinary PE response teams with a more proactive approach to the treatment of PE. In the current document, we discuss the formation of such teams and describe the available treatment options beyond anticoagulation, with a focus on the interventional approach. Acknowledging the paucity of data to support widespread adoption of such techniques, we call for the collection of outcomes data in multicenter registries and support for randomized trials to evaluate interventional treatments in patients with high-risk PE., (Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)

Local institutional-specific credentialing and privileging for procedures is an important process for ensuring the quality of care provided by interventional cardiologists. Recently revised standards for coronary intervention and the blossoming of structural heart disease programs have generated controversy over these processes. How standards are set for credentialing and privileging is poorly understood by most interventional cardiologists, including those responsible for credentialing and privileging. Requirements from The Joint Commission dictate how credentialing and privileging is performed at hospitals they accredit. Physicians must be recredentialed every 2 years at each hospital, with privileges renewed at that time. Hospitals must review quality of physicians even more frequently using Ongoing Professional Practice Evaluations. Hospitals must also evaluate the performance of physicians when they join a hospital staff or when they begin performing new procedures using Focused Professional Practice Evaluations. Cardiology department directors and catheterization laboratory directors are responsible for recredentialing and reprivileging members of their departments. Individual physicians are responsible for cooperating with these processes, and for periodic recertification with specialty boards and governmental agencies. We provide specific guidance to help physicians navigate these processes., (© 2015 Wiley Periodicals, Inc.)

Objectives: To describe the first single center experience with a novel aspiration thrombectomy device., Background: The appearance of inferior vena cava or right-sided intracardiac thrombus may prompt consideration of percutaneous thrombectomy as a method to prevent new or worsening pulmonary embolism (PE). The AngioVac is a novel thrombectomy device composed of a cannula and extracorporeal circuit with filter for pump-assisted removal of intravascular debris which is coupled with a reinfusion catheter for return of blood to the patient. The device has been approved by the United States Food and Drug Administration since 2009. This report represents the first significant case series describing its use, feasibility and outcomes in evacuating large caval thrombi or intracardiac masses in PE., Methods: This is a retrospective analysis of patient and case characteristics and in-hospital clinical outcomes of AngioVac thrombectomy in 14 consecutive patients treated between April 2010 and July 2013 at our institution., Results: Fourteen consecutive patients (mean age 50, 64% female) underwent 15 AngioVac procedures over 40 months. Indications included intracardiac mass (73%), acute PE (33%), and caval thrombus (73%). Four patients (27%) were in shock at the start of the procedure. Peri-procedure mortality was 0% and in-hospital mortality was 13% at a mean follow-up of 23 days. There were no pulmonary hemorrhages, strokes or myocardial infarctions. Though 73% had a post procedural drop in hematocrit, only two bleeding events were related to access site and required a transfusion., Conclusions: AngioVac thrombectomy is feasible in critically ill patients with acute DVT or PE and large caval thrombi or intracardiac masses., (© 2015 Wiley Periodicals, Inc.)

Background: The treatment of peripheral artery disease with percutaneous transluminal angioplasty is limited by the occurrence of vessel recoil and restenosis. Drug-coated angioplasty balloons deliver antiproliferative agents directly to the artery, potentially improving vessel patency by reducing restenosis., Methods: In this single-blind, randomized trial conducted at 54 sites, we assigned, in a 2:1 ratio, 476 patients with symptomatic intermittent claudication or ischemic pain while at rest and angiographically significant atherosclerotic lesions to angioplasty with a paclitaxel-coated balloon or to standard angioplasty. The primary efficacy end point was primary patency of the target lesion at 12 months (defined as freedom from binary restenosis or from the need for target-lesion revascularization). The primary safety end point was a composite of freedom from perioperative death from any cause and freedom at 12 months from limb-related death (i.e., death from a medical complication related to a limb), amputation, and reintervention., Results: The two groups were well matched at baseline; 42.9% of the patients had diabetes, and 34.7% were current smokers. At 12 months, the rate of primary patency among patients who had undergone angioplasty with the drug-coated balloon was superior to that among patients who had undergone conventional angioplasty (65.2% vs. 52.6%, P=0.02). The proportion of patients free from primary safety events was 83.9% with the drug-coated balloon and 79.0% with standard angioplasty (P=0.005 for noninferiority). There were no significant between-group differences in functional outcomes or in the rates of death, amputation, thrombosis, or reintervention., Conclusions: Among patients with symptomatic femoropopliteal peripheral artery disease, percutaneous transluminal angioplasty with a paclitaxel-coated balloon resulted in a rate of primary patency at 12 months that was higher than the rate with angioplasty with a standard balloon. The drug-coated balloon was noninferior to the standard balloon with respect to safety. (Funded by Lutonix-Bard; LEVANT 2 ClinicalTrials.gov number, NCT01412541.).

Background: Stent-based therapy in the superficial femoral and popliteal arteries in patients with peripheral artery disease is compromised by restenosis and risk of stent fracture or distortion. A novel self-expanding nitinol stent was developed that incorporates an interwoven-wire design (Supera stent, IDEV Technologies, Inc, Webster, TX) to confer greater radial strength, flexibility, and fracture resistance., Methods and Results: This prospective, multicenter, investigational device exemption, single-arm trial enrolled 264 patients with symptomatic peripheral artery disease undergoing percutaneous treatment of de novo or restenotic lesions of the superficial femoral or proximal popliteal (femoropopliteal) artery. Freedom from death, target lesion revascularization, or any amputation of the index limb at 30 days (+ 7 days) postprocedure was achieved in 99.2% (258/260) of patients (P < 0.001). Primary patency at 12 months (360 ± 30 days) was achieved in 78.9% (180/228) of the population (P < 0.001). Primary patency by Kaplan-Meier analysis at 12 months (360 days) was 86.3%. No stent fracture was observed by independent core laboratory analysis in the 243 stents (228 patients) evaluated at 12 months. Clinical assessment at 12 months demonstrated improvement by at least 1 Rutherford-Becker category in 88.7% of patients., Conclusions: The SUPERB Trial, an investigational device exemption study using an interwoven nitinol wire stent in the femoropopliteal artery, achieved the efficacy and safety performance goals predesignated by the Food and Drug Administration. On the basis of the high primary patency rate, absence of stent fracture, and significant improvements in functional and quality-of-life measures, the Supera stent provides safe and effective treatment of femoropopliteal lesions in symptomatic patients with peripheral artery disease., Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00933270., (© 2015 American Heart Association, Inc.)

Objectives: The aim of this study was to examine variation in outcomes for patients receiving carotid artery stenting (CAS) across a sample of U.S. hospitals and assess the extent to which this variation was attributable to differences in case mix and procedural volume., Background: As CAS is increasingly being used throughout the United States, assessing hospital variation in CAS outcomes is critical to understanding and improving the quality of care for patients with carotid artery disease., Methods: Hospitals participating in the National Cardiovascular Data Registry-Carotid Artery Endarterectomy and Revascularization Registry contributing more than 5 CAS procedures from 2005 through 2013 were eligible for inclusion. We estimated unadjusted and risk-standardized rates of in-hospital stroke or death for each participating hospital using a previously validated prediction model and applying hospital-level random effects., Results: There were 188 hospitals contributing 19,381 CAS procedures during the period of interest. Unadjusted and risk-standardized in-hospital stroke or death rates ranged from 0% to 18.8% and 1.2% to 4.7%, respectively. Operator and hospital volumes were not significant predictors of outcomes after adjustment for case mix (p = 0.15 and p = 0.09, respectively)., Conclusions: CAS outcomes vary 4-fold among hospitals, even after adjustment for differences in case mix. Future work is needed to identify the sources of this variation and develop initiatives to improve patient outcomes., (Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.)