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Right ventricular assist devices (RVADs) typically require groin cannulation or sternal re-entry which can be avoided by direct pulmonary artery implantation with an Impella. We report the first use of the Impella LD as a directly implanted RVAD.

Objectives This study sought to determine the association of cardiomyopathy etiology with the likelihood of ventricular arrhythmias, appropriate implantable cardioverter-defibrillator (ICD) therapy, and mortality. Background There are conflicting data on the benefit of primary prevention ICD therapy in patients with ischemic versus nonischemic cardiomyopathy (ICM/NICM). Methods The study population comprised 4803 patients with ICM (n = 3,106) or NICM (n = 1,697) with a primary prevention ICD enrolled in 5 randomized trials conducted between 1997 and 2017. The primary end point was sustained ventricular tachycardia (VT) ≥200 beats/min or ventricular fibrillation (VF). Secondary end points included appropriate ICD therapy and all-cause mortality. Differences in cause-specific mortality, including noncardiac, sudden cardiac, and non-sudden cardiac death, were also examined. Results Patients with ICM were significantly older and had more comorbid conditions, whereas those with NICM had a more advanced heart failure class at enrollment and were more often prescribed medical or cardiac resynchronization therapy for heart failure. Multivariate analysis showed that ICM versus NICM had a similar risk of VT/VF events (HR: 0.98 [95% CI: 0.79-1.20]) and appropriate ICD therapy (HR: 1.03 [95% CI: 0.87-1.22]), whereas the risk of all-cause mortality was 1.8-fold higher among ICM versus NICM patients (HR: 1.84 [95% CI: 1.42-2.38]), dominated by non-sudden cardiac mortality. Conclusions Combined data from 5 landmark ICD clinical trials show that ICM patients experience a similar risk of life-threatening ventricular arrhythmic events but have an increased risk of all-cause mortality, dominated by non-sudden cardiac death, compared with NICM patients.

A 22-year-old man with no past medical history presented with an embolic infarct of the left kidney. Imaging demonstrated a large left ventricular mass with extension along the papillary muscles and involvement of the mitral valve ([Figure 1][1]). Tissue diagnosis was recommended, and after heart

Thrombosis of the inferior vena cava (IVC) is an under-recognized entity that is associated with significant short- and long-term morbidity and mortality. In absence of a congenital anomaly, the most common cause of IVC thrombosis is the presence of an unretrieved IVC filter. Due to the substantial increase in the number of IVC filters placed in the United States and the very low filter retrieval rates, clinicians are faced with a very large population of patients at risk for developing IVC thrombosis. Nevertheless, there is a paucity of data and societal guidelines with regards to the diagnosis and management of IVC thrombosis. This paper aims to enhance the awareness of this uncommon, but morbid, condition by providing a concise, yet comprehensive, review of the etiology, diagnostic approaches, and treatment strategies in patients with IVC thrombosis.

We describe the case of a 69-year-old man with a history of bioprosthetic aortic valve replacement who presented with Corynebacterium striatum prosthetic valve endocarditis (PVE) complicated by severe aortic insufficiency with refractory cardiogenic shock despite antibiotic therapy. He was considered a prohibitive-risk surgical candidate due to co-morbid conditions and off-label valve-in-valve transcatheter aortic valve replacement (TAVR) was performed after detailed multidisciplinary evaluation. He recovered well without recurrent infection following completion of antibiotics and transthoracic echocardiogram at 12 months showed a normal functioning prosthetic valve. To our knowledge, this is the first reported case of native or PVE treated with TAVR.

Background— Public reporting of physician-specific outcome data for procedures, such as percutaneous coronary intervention (PCI), can influence physicians to avoid high-risk patients who may benefit from treatment. Prior physician attitudes toward public scorecards in New York State (NYS) have been studied, but the exclusion criteria have evolved. Additionally, patient perceptions toward such reports remain poorly understood. This study evaluates (1) whether exclusion of certain high-risk patients from public reporting of PCI outcomes in NYS has influenced physician attitudes, (2) current patient awareness and use of publicly reported outcome data, and (3) differences in physician and patient attitudes toward public reporting. Methods and Results— A questionnaire was administered to interventional cardiologists in NYS with specific emphasis on how modifications in publicly reported outcome data have influenced their practice. The results were compared with a 2003 survey administered by our group. A separate questionnaire regarding the publicly available NYS PCI Report was administered to patients referred to our center for possible PCI. The majority of interventional cardiologists indicated that the exclusion of patients with anoxic brain injury and refractory cardiogenic shock from public reporting has made them more likely to perform PCI for these subgroups. While patient awareness of the NYS PCI Report was low, patients were significantly more likely than physicians to think that publication of physician-specific mortality data can provide an accurate measure of physician quality, serve to improve patient care, and provide useful information in terms of physician selection. Conclusions— The study provides further evidence that public reporting of physician-specific outcome data influences physician behavior and indicates that significant discrepancies exist in how scorecards are perceived by physicians versus patients.

Summary Background In the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST), the composite primary endpoint of stroke, myocardial infarction, or death during the periprocedural period or ipsilateral stroke thereafter did not differ between carotid artery stenting and carotid endarterectomy for symptomatic or asymptomatic carotid stenosis. A secondary aim of this randomised trial was to compare the composite endpoint of restenosis or occlusion. Methods Patients with stenosis of the carotid artery who were asymptomatic or had had a transient ischaemic attack, amaurosis fugax, or a minor stroke were eligible for CREST and were enrolled at 117 clinical centres in the USA and Canada between Dec 21, 2000, and July 18, 2008. In this secondary analysis, the main endpoint was a composite of restenosis or occlusion at 2 years. Restenosis and occlusion were assessed by duplex ultrasonography at 1, 6, 12, 24, and 48 months and were defined as a reduction in diameter of the target artery of at least 70%, diagnosed by a peak systolic velocity of at least 3·0 m/s. Studies were done in CREST-certified laboratories and interpreted at the Ultrasound Core Laboratory (University of Washington). The frequency of restenosis was calculated by Kaplan-Meier survival estimates and was compared during a 2-year follow-up period. We used proportional hazards models to assess the association between baseline characteristics and risk of restenosis. Analyses were per protocol. CREST is registered with ClinicalTrials.gov, number NCT00004732. Findings 2191 patients received their assigned treatment within 30 days of randomisation and had eligible ultrasonography (1086 who had carotid artery stenting, 1105 who had carotid endarterectomy). In 2 years, 58 patients who underwent carotid artery stenting (Kaplan-Meier rate 6·0%) and 62 who had carotid endarterectomy (6·3%) had restenosis or occlusion (hazard ratio [HR] 0·90, 95% CI 0·63–1·29; p=0·58). Female sex (1·79, 1·25–2·56), diabetes (2·31, 1·61–3·31), and dyslipidaemia (2·07, 1·01–4·26) were independent predictors of restenosis or occlusion after the two procedures. Smoking predicted an increased rate of restenosis after carotid endarterectomy (2·26, 1·34–3·77) but not after carotid artery stenting (0·77, 0·41–1·42). Interpretation Restenosis and occlusion were infrequent and rates were similar up to 2 years after carotid endarterectomy and carotid artery stenting. Subsets of patients could benefit from early and frequent monitoring after revascularisation. Funding National Institute of Neurological Disorders and Stroke and Abbott Vascular Solutions.

Background Coronary revascularization (CR) may confer electrical stability in patients with ischemic cardiomyopathy. However, data regarding the effect of CR on the development of ventricular tachyarrhythmias in this population are limited. Objective The purpose of this study was to evaluate the association between CR and arrhythmic risk in postmyocardial infarction (post-MI) patients with left ventricular dysfunction. Methods The risk for life-threatening ventricular tachyarrhythmias (defined as a first appropriate defibrillator therapy for ventricular tachycardia [VT]/ventricular fibrillation [VF] or death) was compared between post-MI patients with and those without prior CR (n = 612 and 147, respectively) enrolled in the Multicenter Automatic Defibrillator Implantation Trial–Cardiac Resynchronization Therapy (MADIT-CRT). Results The 3-year cumulative rate of VT/VF or death was significantly higher among patients without prior CR (42%) than in patients who underwent prior CR (32%, P = .02). Multivariate analysis demonstrated that patients without prior CR had 48% increased risk ( P = .01) for VT/VF or death. Risk reduction associated with CR was related to elapsed time from CR, assessed both as a categorical variable (tertiles for time from CR: ≥7 years, hazard ratio [HR] = 1.93, P = .001; 1.5–7 years, HR=1.70, P = .01 vs P = .002, increased risk for VT/VF or death per 1-year increment of elapsed time from CR). The effect of CR on arrhythmic risk was similar in patients treated with a defibrillator alone or when combined with cardiac resynchronization therapy. Conclusion Post-MI patients with left ventricular dysfunction who undergo CR experience a time-dependent reduction in the risk for subsequent life-threatening ventricular tachyarrhythmias.

Although angiography remains the gold standard for the diagnosis of renal artery stenosis, renovascular disease can at times present with unusual patterns that may be difficult to detect. The authors present a case in which an initial renal angiogram failed to identify the presence of severe disease involving both a main and accessory renal artery. Repeat angiography coupled with the use of adjunctive catheter-based techniques including translesional pressure gradient determination and intravascular ultrasound with virtual histology imaging revealed the presence of atypical fibromuscular dysplasia that was treated with good clinical results. The case highlights the importance of performing careful and complete renal angiography, including imaging of smaller accessory renal arteries, and describes several readily available catheter-based techniques that can be useful in elucidating the physiological significance and etiology of renal artery stenosis.

Distal embolization due to atherothrombotic debris during subclavian artery interventions is extremely rare and can usually be managed conservatively. Herein, we describe a case of acute hand ischemia due to massive distal embolization during balloon angioplasty and stenting of a left subclavian artery chronic total occlusion. This limb-threatening complication was effectively treated with rescue surgical thrombectomy.

Extracorporeal membrane oxygenation is an important therapeutic option for patients with refractory cardiogenic shock. Adequate decompression of the left ventricular in these patients is a key predictor of successful recovery. The currently available percutaneous decompression techniques are limited by their partial unloading capability.We describe a series of four consecutive patients with refractory cardiogenic shock in whom adequate left ventricular decompression was achieved by integrating a transseptally placed left ventricular cannula into the existing extracorporeal membrane oxygenation circuit.From May to June 2015, four consecutive patients underwent transvenous transseptal left ventricular decompression with a 22 French cannula that was integrated into the extracorporeal membrane oxygenation circuit in a Y fashion. The mean age was 47.5 ± 20 years. All patients had refractory shock, and three patients failed prior decompression with an intra-aortic balloon pump. Fluoroscopy time was 12.15 ± 2.6 minutes. No procedural complications were noted. All patients had significant reduction in their pulmonary capillary wedge pressure and resolution of their pulmonary edema. Two patients died during the hospitalization due to sepsis and/or multiorgan failure.Antegrade transseptal left ventricular decompression is feasible in patients on extracorporeal membrane oxygenation and persistent pulmonary edema.

Coronary artery stent infection is a rare complication of percutaneous intervention. We report a case of fulminant coronary stent infection with Staphylococcus aureus presenting as a pseudoaneurysm of the left circumflex artery following repeated implantation of drug-eluting stents in the setting of multiple episodes of recurrent in-stent restenosis. We speculate that sirolimus- and paclitaxel-eluting stents may be more likely to predispose to infection than bare metal stents because of their immunomodulating and antiproliferative effects.

Objectives: We conducted a randomized trial to determine the efficacy of two topical hemostasis pads in promoting vascular hemostasis following PCI, and to assess the appropriate level of anticoagulation for sheath removal. Background: Pads coated with procoagulant materials are widely marketed and used to augment vascular hemostasis following PCI, yet clinical effectiveness and safety data are lacking. Methods: 184 patients who underwent PCI using the femoral approach were randomized to one of four methods of sheath removal: (1) at ACT < 250 using the Chito-Seal™ pad; (2) at ACT < 250 using the Clo-Sur PAD™; (3) at ACT < 250 using manual compression alone; (4) at ACT < 170 using manual compression alone. Results: Time to hemostasis was significantly shorter in the hemostasis pad groups compared to the conventional compression groups (16.2 ± 4.9, 16.0 ± 5.3, 19.3 ± 7.8, and 18.3 ± 5.7 min, respectively, P = 0.027), however overall bed rest times following intervention were not reduced by use of either hemostasis pad. The incidence of major or minor bleeding complications did not differ among groups. Irrespective of hemostasis pad use, removal of sheaths at higher ACT levels allowed shorter time to ambulation following PCI without an increase in bleeding events. Conclusions: The hemostasis pads tested shortened time to hemostasis compared to standard manual compression, although the absolute reduction in time to hemostasis was relatively small and did not translate into a reduction in overall bed rest time. Independent of hemostasis pad use, removal of arterial sheaths at higher than conventional activated clotting times was safe and resulted in significant reductions in time to ambulation. © 2006 Wiley-Liss, Inc.

The management of complex cardiovascular disease is rapidlyshifting from individual physician based practice towards a multidisci-plinary team approach. The plethora of scientific data and the develop-ment of new strategies of care led to the wide adoption of the ‘HeartTeam’ or the ‘Cardiovascular Team’ concept, where cardiologists workclosely with cardiacsurgeons, vascular surgeons, neurologists, anesthe-siologists, radiologists, interventional radiologists and other specialiststo deliver a high-quality cardiovascular care. The importance of this‘patient-centered’ and not ‘specialty-centered’ approach is well recog-nizedbymultiplesocietiesanditsadoptionisthereforestronglyrecom-mended in most contemporary guidelines [1]. The evolution of thiscollaborative team approach has transformed how cardiovascularspecialists interact and provide patient care, and possibly resultedin improved outcomes. Unfortunately, educational models have notkept pace with these changes. In most cardiovascular fellowshiptraining programs, fellows' exposure to other key specialtiesislimit-ed to didactic lectures, and scattered patient-care related interac-tions. In the era of multispecialtyteam approach, this exposure ofcardiovascular fellows to their future team collaborators is far fromadequate.The most recent guidelines for Training in Adult CardiovascularMedicine acknowledge the importance of multidisciplinary trainingbutdonotprovidespecificrecommendationswithregardtoitsapplica-tion [2]. The guidelines states that ‘specialists in cardiovascular diseasemust interact with generalists and specialists in other areas and haveknowledge of other specialties to provide excellent patient care. Close

Carotid artery stenting has emerged as an alternative to carotid endarterectomy for the treatment of severe extracranial carotid stenosis in patients with anatomic or clinical factors that increase their risk of complications with surgery, yet there remains a substantial amount of variability and uncertainty in clinical practice in the referral of patients for stenting vs endarterectomy. By undertaking a thorough review of the literature, we sought to better define which subsets of patients with "high-risk" features would be likely to preferentially benefit from carotid stenting or carotid endarterectomy. Although only a single randomized trial comparing the outcomes of carotid stenting with distal protection and endarterectomy has been completed, a wealth of observational data was reviewed. Relative to endarterectomy, the results of carotid stenting seem favorable in the setting of several anatomic conditions that render surgery technically difficult, such as restenosis after prior endarterectomy, prior radical neck surgery, and previous radiation therapy involving the neck. The results of stenting are also favorable among patients with severe concomitant cardiac disease. Carotid endarterectomy, alternatively, seems to represent the procedure of choice among patients 80 years of age or older in the absence of other high-risk features. Overall, existing data support the concept that carotid stenting and endarterectomy represent complementary rather than competing modes of therapy. Pending the availability of randomized trial data to help guide procedural selection, which is likely many years away, an objective understanding of existing data is valuable to help select the optimal mode of revascularization therapy for patients with severe carotid artery disease who are at heightened surgical risk.

ObjectivesThe purpose of this study was to determine whether performance on a simulator model of carotid artery stenting correlates with previous endovascular experience and to assess the effects of repetition and training.MethodsParticipants were stratified to untrained and advanced skill groups on the basis of number of endovascular procedures previously performed. Baseline performance was assessed by means of a pretest, and participants were randomized to practice and no-practice groups. Practice consisted of a 30-minute to 60-minute proctored session before taking a final test; those in the no-practice group proceeded directly to the final test without this session. Primary outcomes were completion of a standardized protocol and the length of time needed to complete all steps.ResultsTwenty-nine subjects (16 untrained, 13 advanced) participated fully in the study. Ninety-two percent of participants in the advanced group successfully completed the pretest, versus 63% in the untrained group (P = .09); mean time to successful completion was 29.9 ± 4.8 (mean ± SD) versus 48.0 ± 9.9 minutes, respectively (P < .001). Subjects who received no practice did not significantly improve their completion times between pretest and final test, whereas those who received practice did (novice, 47.9 ± 7.0 minutes vs 24.5 ± 2.9 minutes, P < .001; advanced, 29.6 ± 3.1 minutes vs 20.2 ± 4.1 minutes, P < .001). The group without previous training had significantly more time improvement from training than did the advanced group. Exit survey results showed that those who had the opportunity to practice more commonly believed that the simulator increased their endovascular skills and interest in vascular surgery (both P < .01 vs untrained group).ConclusionsPerformance on the carotid stenting simulator correlated with previous endovascular experience. Although both novice and advanced groups improved their time after a 30-minute to 60-minute proctored training session, improvement in the novice group was greater than that in the advanced group, which suggests that novices may benefit disproportionately from this type of training.

Corynebacterium species is an uncommon organism involved in prosthetic valve endocarditis (PVE). It is a common skin flora, however it can be a pathogen in endocarditis especially in immunocompromised patients or patients with prosthetic valves. The treatment for congestive heart failure (CHF) in

OBJECTIVES We sought to determine whether periprocedural myocardial infarction complicating percutaneous coronary revascularization is associated with subsequent clinical restenosis, as judged by the need for target vessel revascularization. BACKGROUND Although myocardial enzyme elevation following angioplasty is associated with increased late mortality, its effect on subsequent clinical restenosis, as assessed by the need for late target vessel revascularization (TVR), is unknown. METHODS Serial myocardial enzyme determinations were performed on 2,099 patients who underwent angioplasty or atherectomy in the Evaluation of IIb/IIIa platelet receptor antagonist 7E3 in Preventing Ischemic Complications (EPIC) trial. Thirty-day survivors were prospectively followed for three years for adverse clinical events including death and need for TVR. RESULTS Within the study population, periprocedural creatine kinase (CK) elevation was a predictor of late mortality. Among patients with elevated CK, however, a paradoxical decrease in the need for late TVR was present. This relationship became progressively more profound as the magnitude of CK release increased. Late TVR occurred in 29.8% of patients with no CK elevation, 24.8% with CK elevation to >3 times normal, and 16.9% with >10 times elevation (hazard ratio 0.51, 95% CI 0.29, 0.91). CONCLUSIONS In the EPIC study, patients with periprocedural MI were less likely to develop clinical restenosis as measured by the need for TVR. Mechanistically, although it is unlikely that CK elevation prevents vascular renarrowing per se, myocardial necrosis impairs the clinical manifestation of restenosis, thereby reducing the need for ischemia-driven TVR. This novel finding 1) highlights the potential discordance between angiographic and clinical measures of restenosis, and 2) has implications for clinical trials, as therapies that reduce periprocedural MI may be associated with a perceived excess of restenosis when measured by the need for TVR.

During the past 20 years, the equipment used to perform percutaneous coronary revascularization has undergone a dramatic transformation from simple balloon dilatation catheters to sophisticated mechanical devices and endoprostheses. The impetus for this evolution in technology was initially a byproduct of suboptimal immediate and long-term results obtained with standard balloon angioplasty. New techniques, including directional and rotational atherectomy, have resulted in improved procedural success rates, especially for more complex lesion subtypes, although their ability to curtail restenosis remains controversial.1 2 Intracoronary stents have had a dramatic impact on reduction of the incidence of acute complications after failed balloon angioplasty and represent the only currently available strategy shown to limit both clinical and angiographic restenosis.3 4 5 6 7 8 9 10 11 12 Based on these advantages, stent implantation is used in approximately half of all percutaneous interventions in the United States. However, despite their proven benefits, coronary stents continue to be accompanied by several theoretical and practical limitations: they are costly, typically associated with a more marked degree of neointimal formation than balloon angioplasty, and difficult to use with some lesion subsets such as bifurcation stenoses, and they have engendered the new and difficult-to-treat entity of in-stent restenosis. Although the major focus in the field of interventional cardiology over the past decade has been on the development of new devices and adjunctive pharmacological therapies, the short- and long-term success rates after standard balloon angioplasty have improved significantly. Part of the improvement is likely a manifestation of enhanced operator experience and better equipment, but the results of balloon angioplasty have also benefited greatly from the availability of coronary stents for both “bailout” (for actual or threatened abrupt closure) or “backup” (for suboptimal balloon results) indications, potentially allowing a strategy of more aggressive balloon dilatation than could be safely …

Methods Two hundred seventy-one patients with a recent acute coronary event underwent pain tolerance testing using the tourniquet test. Baseline ambulatory and exercise electrocardiography, and stress thallium scintigraphy were performed, and patients were followed prospectively for a mean of 33 ± 8 months for the occurrence of unstable angina, nonfatal myocardial infarction (Ml), or cardiac death. Results Patients with lower tolerance to somatic pain were significantly older (P = 0.001), had more clinical angina (P = 0.04), and on multivariate analysis had poorer exercise tolerance (P = 0.002) than those with higher pain tolerance. Low and high pain tolerance patients demonstrated similar degrees of myocardial ischemia on noninvasive testing and had similar cardiac event rates (death, nonfatal Ml, or unstable angina) during the follow-up period. Conclusions Despite demonstrating a similar frequency of myocardial ischemia and similar prognosis as patients with high pain tolerance, individuals with low pain tolerance were more likely to experience clinical symptoms and functional impairment, providing evidence that individual differences in somatic pain tolerance influence the symptomatic expression of coronary disease.

Coronary artery bypass graft surgery improves survival for certain subsets of patients with coronary artery disease and has been accepted as the revascularization “gold standard” since the 1970s. PTCA, introduced by Gruentzig in 1977, was initially envisioned as a potentially serial treatment for patients with focal coronary artery disease to prevent the development of complex disease severe enough to require CABG. By the mid-1980s, however, expertise and technology had improved to the point that PTCA could, apparently with reasonable success and safety, be brought to bear on anatomic situations previously considered to be solely the realm of the cardiovascular surgeon. To ascertain whether PTCA for patients with moderately advanced disease was truly an appropriate alternative to CABG, several RCTs were undertaken. At the time, it appeared that both revascularization alternatives were sufficiently mature that the long-term results would be relevant when they became available 5 to 10 years later. In aggregate, 4310 patients with multivessel disease thought to be suitable for either form of revascularization (thereby excluding many patients with far advanced disease) were enrolled in six RCTs between 1986 and 1991. The overall trial results were remarkably concordant. CABG was associated with a slight but not statistically significant survival advantage, less angina, and far fewer later revascularizations. PTCA led to a slight but insignificant reduction in myocardial infarction over the ensuing 2 to 5 years.1 2 3 4 5 6 Critics of RCTs often contest the generalizability of the treatment outcomes reported. They question whether it might be an oversimplification to apply the overall results of a trial both to all of its component patients and also to all similar but nonrandomized patients. In fact, given the general homogeneity engendered by the focus of most clinical trials, it is unusual for some patients to benefit and others to …

Objectives. This study was undertaken to better understand the functional and prognostic significance of silent relative to symptomatic ischemia. Background. Previous studies have reached conflicting conclusions as to whether painless ischemia identified during noninvasive cardiac testing is related to a lesser extent of myocardial ischemia or a different prognosis than ischemia accompanied by angina, or both. Methods. Nine hundred thirty-six clinically stable patients 1 to 6 months after an acute coronary event, either myocardial infarction or unstable angina, underwent ambulatory monitoring, exercise treadmill testing and stress thallium-201 scintigraphy. They were then followed up prospectively for a mean of 23 months for recurrent cardiac events (cardiac death, nonfatal myocardial infarction or unstable angina). Results. Compared with patients with symptomatic ischemia during testing (n = 125), those with silent ischemia (n = 378) demonstrated less severe and extensive reversible defects on stress thallium scintigraphy (p = 0.0008), less functional impairment during treadmill testing manifested by longer exercise duration (640 ± 173 vs. 529 ± 190 s, p = 0.002) and longer time to ST segment depression (530 ± 215 vs. 419 ± 205 s, p = 0.0001) and less frequent ST segment depression during ambulatory monitoring (9% vs. 19%, p = 0.005). Patients with symptomatic ischemia had a significantly (p = 0.004) increased number of subsequent recurrent cardiac events (28.8%) versus those with silent (18.0%) or no (17.3%) ischemia. Adverse outcomes were especially concentrated in the subgroup with symptomatic ischemia and poor exercise tolerance. The difference in cardiac event rates between patients with silent versus symptomatic ischemia persisted after adjustment for baseline clinical characteristics by Cox regression analysis. Conclusions. Patients with painless ischemia during exercise testing 1 to 6 months after recovery from a coronary event have less jeopardized ischemic myocardium and fewer recurrent cardiac events than patients with symptomatic ischemia. (J Am Coll Cardiol 1997;29:756–63)

Serum levels of interleukin-18 (IL-18) and its endogenous antagonist IL-18 binding protein were measured in 84 patients before and after coronary angioplasty. Patients who had high levels of troponin I immediately before angioplasty were considered to have experienced a "recent" myocardial infarction. Concentrations of IL-18 (355 vs 316 pg/ml) and ratio of IL-18 to IL-18 binding protein (107 vs 69) were significantly higher among patients who had recent myocardial infarction than among those who did not, indicating a relation between unopposed IL-18 activity and recent myocardial infarction.

Objectives The Carotid Revascularization Endarterectomy versus Stenting Trial (CREST) showed no difference in the composite endpoint of stroke, myocardial infarction, or death between carotid artery stenting (CAS) and carotid endarterectomy (CEA) in patients with symptomatic or asymptomatic carotid stenosis (CS). We compared restenosis or occlusion, and repeat revascularization, between CAS and CEA over 2 years of follow-up. Methods Restenosis, occlusion, and repeat revascularization were assessed at 1, 6, 12 and 24 months post-randomization. Hemodynamically significant restenosis (≥70% diameter reduction) was defined by a peak systolic velocity (PSV) ≥300 cm/second on standardized duplex ultrasonography (DUS), occlusion by an absence of flow within the target artery on DUS, and repeat revascularization by any additional procedure (CEA, angioplasty or CAS) performed on the index artery. Studies were performed in CREST-certified laboratories and interpreted in the CREST Ultrasound Core Lab. Patients included in this report were those who received their assigned treatment within 30 days of randomization and had an ultrasound reviewed at the Core Lab (n=2191). Treatment differences were assessed using proportional hazards models adjusting for age, sex, and symptomatic status. Results In the analytic cohort, 1086 patients received CAS and 1105 received CEA. Over 2 years 113 patients developed restenosis, 56 (rate 5.8%) in the CAS group and 57 (rate 5.8%) in the CEA group; and 8 developed an occlusion, 3 (rate 0.3 %) in the CAS group and 5 (rate 0.5%) in the CEA group. The combined restenosis-occlusion rate was 6.0% (n=58) for CAS and 6.3% (n=62) for CEA (HR=0.90, 95% CI=0.63-1.29, p=0.58). Forty-three patients of the 2191 underwent repeat revascularization (20 CAS, 23 CEA, p=0.69) of which 28 had restenosis by our criteria and so were included ( Figure ). Stroke occurred in 13 (4 CAS; 9 CEA) of the 120 patients with restenosis or occlusion; 1 of the 4 CAS strokes occurred after restenosis was detected, and 5 of 9 CEA strokes occurred after restenosis was detected. Conclusions This analysis of carotid restenosis is the largest reported to date from any randomized clinical trial. Restenosis and occlusion were infrequent and similar up to 2 years following CAS or CEA among 2191 patients. The rates of revascularization likewise did not differ between CAS and CEA. Follow-up out to 10 years is ongoing. Figure. Kaplan-Meier curves of restenosis and occlusion over 2 years.

Peripheral arterial disease (PAD) is a common yet vastly underdiagnosed condition that is associated with substantial morbidity and mortality. Because atherosclerosis is a systemic disease, the presence of PAD, whether symptomatic or not, is associated with a two- to fourfold increase in the risk of myocardial infarction, stroke and cardiovascular death [1–3]. More timely diagnosis of PAD in the primary care setting has the potential not only to improve quality of life by helping to alleviate the lifestyle-impairing symptoms often associated with the disease, but also to identify individuals at high risk for cardiac and cerebrovascular events providing the opportunity to initiate effective life-saving therapies at an earlier stage [4].

Background— The Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST) found a higher risk of stroke after carotid artery stenting and a higher risk of myocardial infarction (MI) after carotid endarterectomy. Methods and Results— Cardiac biomarkers and ECGs were performed before and 6 to 8 hours after either procedure and if there was clinical evidence of ischemia. In CREST, MI was defined as biomarker elevation plus either chest pain or ECG evidence of ischemia. An additional category of biomarker elevation with neither chest pain nor ECG abnormality was prespecified (biomarker+ only). Crude mortality and risk-adjusted mortality for MI and biomarker+ only were assessed during follow-up. Among 2502 patients, 14 MIs occurred in carotid artery stenting and 28 MIs in carotid endarterectomy (hazard ratio, 0.50; 95% confidence interval, 0.26 to 0.94; P =0.032) with a median biomarker ratio of 40 times the upper limit of normal. An additional 8 carotid artery stenting and 12 carotid endarterectomy patients had biomarker+ only (hazard ratio, 0.66; 95% confidence interval, 0.27 to 1.61; P =0.36), and their median biomarker ratio was 14 times the upper limit of normal. Compared with patients without biomarker elevation, mortality was higher over 4 years for those with MI (hazard ratio, 3.40; 95% confidence interval, 1.67 to 6.92) or biomarker+ only (hazard ratio, 3.57; 95% confidence interval, 1.46 to 8.68). After adjustment for baseline risk factors, both MI and biomarker+ only remained independently associated with increased mortality. Conclusions— In patients randomized to carotid endarterectomy versus carotid artery stenting, both MI and biomarker+ only were more common with carotid endarterectomy. Although the levels of biomarker elevation were modest, both events were independently associated with increased future mortality and remain an important consideration in choosing the mode of carotid revascularization or medical therapy. Clinical Trial Registration— URL: http://www.ClinicalTrials.gov . Unique identifier: NCT00004732.

An operator's ability to determine the optimal vascular access strategy for patients undergoing peripheral endovascular intervention is critical to maximizing procedural safety and success. Individualizing an approach to access requires careful planning, and is contingent upon a solid general knowledge of normal and abnormal vascular anatomy, as well as the particulars of each patient's history, physical examination, and non-invasive test results. An awareness of the technical nuances, relative safety, and indications for obtaining percutaneous arterial access at all potential sites is essential. Available means for approaching lower extremity arterial disease include the retrograde and antegrade common femoral approaches, the contralateral crossover technique, upper extremity approaches from the radial, brachial, or axillary arteries, or occasionally retrograde access via the popliteal, dorsalis pedis, or tibial arteries. These techniques, as well as important considerations for approaching disease of the renal, subclavian, and carotid arteries are reviewed.

The use of topical hemostasis patches has grown rapidly despite a paucity of evidence supporting their clinical utility. We performed a randomized, controlled trial to assess the efficacy of a topical hemostasis patch as a means to accelerate vascular hemostasis following percutaneous intervention. One hundred fifty (150) patients undergoing coronary or peripheral intervention through a 6 Fr femoral arterial sheath were randomized to sheath removal with either: (1) manual pressure and adjunctive use of a patch incorporating a polysaccharide based procoagulant material (SafeSeal Patch, Possis Medical Inc.); or (2) conventional manual pressure alone. Sheaths were removed when the activated clotting time (ACT) fell toor = 250 seconds. Patients ambulated 2 hours after hemostasis was achieved. Time to hemostasis (duration of compression required until cessation of bleeding following sheath removal) was significantly lower in the hemostasis patch arm (11.8 +/- 3.6 vs. 13.8 +/- 5.8 minutes; p = 0.02). Attainment of hemostasis in15 minutes was also more likely among patients randomized to the hemostasis patch rather than manual compression alone (odds ratio = 2.5; 95% confidence intervals 1.2, 5.1; p = 0.014). The median time to ambulation (total duration from the end of the interventional procedure to ambulation) was significantly reduced among patients in the hemostasis patch arm (2.8 vs. 3.8 hours; p = 0.03). Bleeding complications were uncommon and did not differ between the study arms. In conclusion, this trial supports the concept that the polysaccharide-based SafeSeal Patch enhances access site hemostasis following endovascular intervention.

Background: Previous studies have indicated that, compared with men, women are at increased risk for in-hospital mortality following percutaneous coronary intervention (PCI); however, angioplasty techniques and mortality rates have improved since earlier reports. Hypothesis: We sought to reevaluate and explore further the relationship between gender and angioplasty outcomes in contemporary “real world” practice. Methods: The influence of gender and other covariates on in-hospital mortality and other adverse events among all patients who underwent elective coronary angioplasty in New York State from 1999 to 2001 (n= 106,262) was examined. Results: In-hospital mortality rates for elective angioplasty were low; however, women demonstrated a two-fold mortality excess compared with men (0.6vs. 0.3%, p

A 44-year-old woman underwent fractional flow reserve (FFR) assessment of a stenosis of the left circumflex coronary artery. The FFR was within normal limits, however, shortly after leaving the catheterization laboratory the patient developed refractory angina. Repeat angiography demonstrated a new filling defect in the mid left anterior descending coronary artery. Aspiration thrombectomy was performed, and analysis of the effluent revealed a strand of gauze material with adherent thrombus. The gauze fiber was likely unknowingly injected with flush solution during FFR measurement. This previously unreported but potentially dangerous phenomenon underscores the importance of not using a single receptacle to hold moist gauze and saline flush solution, as is the practice in some catheterization laboratories.

ObjectivePrior work has established that performance on an endovascular simulator incorporating tactile feedback (haptics) correlates with previous endovascular experience and can be improved by training. This study was designed to test the ability to define and measure innate endovascular aptitude and empirically correct performance and to determine whether these are two different things.MethodsSubjects ranging in endovascular skill level from novice to expert were surveyed to determine video game experience and skill, endovascular level of training, and endovascular experience. They were then tested by using a standard protocol requiring timed advancement of a catheter and wire sequentially into each of three vessels arising from a simulated type I arch. Recorded trials were independently and blindly scored by two experienced endovascular faculty members by using a modification of a previously validated scale (Modified Reznick Scale; MRS). Summed scores were analyzed by frequency analysis and categorized as satisfactory and unsatisfactory on the basis of a clear bimodal distribution. Categorical outcome, time to task completion, and other variables were analyzed by means of linear regression, analysis of variance, and Welch modified two-sample t tests, as indicated.ResultsA total of 61 subjects were enrolled: 42% students, 8% technicians, 19% surgeons, 13% cardiologists, and 18% radiologists. Of these, 62% were considered novices and 30% experts on the basis of previous experience; 56% of subjects worked in an endovascular-related occupation. MRS scores were highly correlated between raters (P < .0001) and showed a clear bimodal distribution, with subjects in any endovascular occupation (including technicians) scoring significantly better than all others (P < .0001). Hours of video games played per week were correlated highly with completion times (P < .001) and MRS scores (P < .001). Measures of formal training (number of endovascular cases and occupation) correlated highly with completion times (all P < .03) and MRS scores (all P < .008). In comparing completion times vs MRS scores, three groups were apparent: unskilled-inexperienced, skilled-inexperienced, and skilled-experienced, corresponding primarily to senior subjects without endovascular experience, younger subjects without endovascular experience, and formally trained endovascular physicians, respectively. Those judged intermediate in aptitude reduced times to the lowest possible level before improving their MRS scores.ConclusionsAlthough inherently subjective, the MRS yields reproducible scores that correlate with endovascular experience and formal training. Experts and novices with extensive video game experience achieve short completion times, whereas high MRS scores are achieved only by formally trained subjects. Innate endovascular aptitude and empirically correct performance may be two separate things, and aptitude may be acquirable through (or identified by) extensive nonmedical video game experience.

Background Among coronary disease patients, concomitant peripheral arterial disease is a potent risk factor for future cardiac events and mortality. We sought to determine clinical and biochemical markers that might better elucidate the relationship between coronary and peripheral arterial disease. Methods Two months after an index myocardial infarction, 1045 patients provided detailed medical histories and underwent blood testing for selected hemostatic, lipid, and inflammatory markers. Patients were then followed up prospectively for a mean of 26 months. Results Compared with individuals without intermittent claudication (n = 966), those with claudication (n = 78) (information was unavailable for 1 individual) were significantly older and demonstrated an increased frequency of diabetes mellitus, tobacco use, prior cardiac and cerebrovascular events, and depressed left ventricular function. Individuals with claudication were less likely to receive β-blocker therapy after the index infarction. Individuals with claudication had evidence of enhanced procoagulant and proinflammatory states manifested by relative elevations in plasma fibrinogen, D-dimer, C-reactive protein, and serum amyloid A concentrations. During follow-up, the presence of claudication was associated with an independent 2-fold increase in the combined end point of death or nonfatal cardiac event (38.5% vs 17.8%, P = .001) and a 5-fold increase in cardiac mortality (19.2% vs 3.6%, P = .001). Patients with intermittent claudication who were not treated with β-blockers had a significant 3-fold mortality excess relative to those receiving β-blockers. Conclusions Following myocardial infarction, the added presence of intermittent claudication is associated with heightened procoagulant and proinflammatory states and an underuse of β-blocker therapy and is a strong independent predictor of recurrent cardiovascular events.

A case report of a patient who had valvular strands while undergoing treatment with thrombolytic therapy for prosthetic mitral valve thrombosis is presented. The development of valvular strands during thrombolytic therapy provides unique evidence supporting a thrombotic/fibrotic origin to this relatively common finding on transesophageal echocardiography.

Background The purpose of this study was to determine whether the degree of heparin anticoagulation during coronary angioplasty, as measured by the activated clotting time, is related to the risk of abrupt vessel closure. Methods and Results Sixty-two cases of in- and out-of-laboratory abrupt closure in patients in whom intraprocedure activated clotting times were measured were identified from a population of 1290 consecutive patients who underwent nonemergency coronary angioplasty. This group was compared with a matched control population of 124 patients who did not experience abrupt closure. Relative to the control population, patients who experienced abrupt closure had significantly lower initial (median, 350 seconds [25th to 75th percentile, 309 to 401 seconds] versus 380 seconds [335 to 423 seconds], P =.004) and minimum (345 seconds [287 to 387 seconds] versus 370 seconds [321 to 417 seconds], P =.014) activated clotting times. Higher activated clotting times were not associated with an increased likelihood of major bleeding complications. Within this population, a strong inverse linear relation existed between the activated clotting time and the probability of abrupt closure. Conclusions This study demonstrates a significant inverse relation between the degree of anticoagulation during angioplasty and the risk of abrupt closure. A minimum target activated clotting time could not be identified; rather, the higher the intensity of anticoagulation, the lower the risk of abrupt closure.

Background Public disclosure of physician-specific performance data is becoming increasingly common. However, the influence that public reporting of outcome data has on the delivery of care by physicians who are being assessed is not well understood. Methods Since 1994, the New York State Department of Health has collected and periodically published observed and risk-adjusted patient mortality rates for all interventional cardiologists practicing coronary angioplasty in the state. To assess the influence that these reports exert on the physicians being monitored, a questionnaire was administered in an anonymous manner to all interventional cardiologists included in the most recent report. Results The vast majority (79%) of interventional cardiologists agreed or strongly agreed that the publication of mortality statistics has, in certain instances, influenced their decision regarding whether to perform angioplasty on individual patients. Physicians expressed an increased reluctance to intervene in critically ill patients with high expected mortality rates. Among the respondents, 83% agreed or strongly agreed that patients who might benefit from angioplasty may not receive the procedure as a result of public reporting of physician-specific patients’ mortality rates. Additionally, 85% believed that the risk-adjustment model used in the Percutaneous Coronary Interventions (PCI) in New York State 1998-2000 report is not sufficient to avoid punishing physicians who perform higher-risk interventions. Conclusions Public reporting of physician-specific outcome data may influence physicians to withhold procedures from patients at higher risk, even when physicians believe that the procedure might be beneficial. This phenomenon should be recognized in the design and administration of physician performance profiles.

Although previous studies have shown that patients with silent myocardial ischemia tend to be less sensitive to somatic pain than individuals with symptomatic coronary disease, the clinical relevance of this association has not been examined prospectively. The tourniquet test. a previously validated indicator of somatic pain tolerance. was performed on 280 patients 2.7 ± 1.4 months following an acute index coronary event – either myocardial infarction (MI, n = 192) or unstable angina (n = 88). Patients were then followed for a mean of 2 years. The relationship between pain tolerance (PT) and several clinical and ischemic test variables (including stress thallium scintigraphy–STS) was examined. Variable High PT LowPT Multivariate (n = 121) (n = 159) P value Age (years) 57 ± 10 61 ± 9 0.005 Female (%) 14 19 NS Diabetes (%) 19 21 NS Prior MI(%) 39 41 NS Prior Angina (%) 45 61 0.01 Ischemia on STS (%) 45 34 0.03 Recurrent MI or Death (%) 9 6 NS Multivariate logistic regression analysis revealed that patients with high PT were more likely to be younger (odds ratio (OR) = 1.5), to have no history of angina prior to the index event (OR = 2.0), and to have ischemia on STS lOR = 1.8) than low PT, patients. There was no difference in cardiac event rates (death or nonfatal MI) between the low and high PT groups. Conclusion Patients with a high PT appear to have an impaired anginal warning system. The high PT patients had less angina prior to the index coronary event. but more inducible ischemia after the coronary event.