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BACKGROUND: The superiority of balloon angioplasty plus aggressive medical management (AMM) to AMM alone for symptomatic intracranial artery stenosis (sICAS) on efficacy and safety profiles still lacks evidence from randomised controlled trials (RCTs). AIM: To demonstrate the design of an RCT on balloon angioplasty plus AMM for sICAS. DESIGN: Balloon Angioplasty for Symptomatic Intracranial Artery Stenosis (BASIS) trial is a multicentre, prospective, randomised, open-label, blinded end-point trial to investigate whether balloon angioplasty plus AMM could improve clinical outcome compared with AMM alone in patients with sICAS. Patients eligible in BASIS were 35-80 years old, with a recent transient ischaemic attack within the past 90 days or ischaemic stroke between 14 days and 90 days prior to enrolment due to severe atherosclerotic stenosis (70%-99%) of a major intracranial artery. The eligible patients were randomly assigned to receive balloon angioplasty plus AMM or AMM alone at a 1:1 ratio. Both groups will receive identical AMM, including standard dual antiplatelet therapy for 90 days followed by long-term single antiplatelet therapy, intensive risk factor management and life-style modification. All participants will be followed up for 3 years. STUDY OUTCOMES: Stroke or death in the next 30 days after enrolment or after balloon angioplasty procedure of the qualifying lesion during follow-up, or any ischaemic stroke or revascularisation from the qualifying artery after 30 days but before 12 months of enrolment, is the primary outcome. DISCUSSION: BASIS trail is the first RCT to compare the efficacy and safety of balloon angioplasty plus AMM to AMM alone in sICAS patients, which may provide an alternative perspective for treating sICAS. TRIAL REGISTRATION NUMBER: NCT03703635; https://www. CLINICALTRIALS: gov.

Chronic thromboembolic pulmonary hypertension (CTEPH) is a treatable form of pulmonary hypertension and right heart failure. CTEPH (group 4 pulmonary hypertension) is caused by persistent organized thromboembolic obstruction of the pulmonary arteries from incompletely resolved acute pulmonary embolism. CTEPH also may present without prior VTE history, which can contribute to its underrecognition. The true incidence of CTEPH is unclear, but is estimated to be approximately 3% after acute pulmonary embolism. V˙/Q˙ scintigraphy is the best screening test for CTEPH, with CT scan imaging and other advanced imaging methods now playing a larger role in disease detection and confirmation. Perfusion defects on V˙/Q˙ scintigraphy in the setting of pulmonary hypertension are suggestive of CTEPH, but pulmonary angiography and right heart catheterization are required for confirmation and treatment planning. CTEPH potentially is curative with pulmonary thromboendarterectomy surgery, with mortality rates of approximately 2% at expert centers. Advances in operative techniques are allowing more distal endarterectomies to be performed successfully with favorable outcomes. However, more than one-third of patients may be considered inoperable. Although these patients previously had minimal therapeutic options, effective treatments now are available with pharmacotherapy and balloon pulmonary angioplasty. Diagnosis of CTEPH should be considered in all patients with suspicion of pulmonary hypertension. Treatments for CTEPH have advanced with improvements in outcomes for both operable and inoperable patients. Therapy should be tailored based on multidisciplinary team evaluation to ensure optimal treatment response.

Chronic thromboembolic pulmonary hypertension (CTEPH) is a rare complication of acute pulmonary embolism. It is caused by persistent obstruction of pulmonary arteries by chronic organised fibrotic clots, despite adequate anticoagulation. The pulmonary hypertension is also caused by concomitant microvasculopathy which may progress without timely treatment. Timely and accurate diagnosis requires the combination of imaging and haemodynamic assessment. Optimal therapy should be individualised to each case and determined by an experienced multidisciplinary CTEPH team with the ability to offer all current treatment modalities. This report summarises current knowledge and presents key messages from the International CTEPH Conference, Bad Nauheim, Germany, 2021. Sessions were dedicated to 1) disease definition; 2) pathophysiology, including the impact of the hypertrophied bronchial circulation, right ventricle (dys)function, genetics and inflammation; 3) diagnosis, early after acute pulmonary embolism, using computed tomography and perfusion techniques, and supporting the selection of appropriate therapies; 4) surgical treatment, pulmonary endarterectomy for proximal and distal disease, and peri-operative management; 5) percutaneous approach or balloon pulmonary angioplasty, techniques and complications; and 6) medical treatment, including anticoagulation and pulmonary hypertension drugs, and in combination with interventional treatments. Chronic thromboembolic pulmonary disease without pulmonary hypertension is also discussed in terms of its diagnostic and therapeutic aspects.

BackgroundGiant cell arteritis (GCA) is a systemic vasculitis that may cause ischemic stroke. Rarely, GCA can present with aggressive intracranial stenoses, which are refractory to medical therapy. Endovascular treatment (EVT) is a possible rescue strategy to prevent ischemic complications in intracranial GCA but the safety and efficacy of EVT in this setting are not well-described.MethodsA systematic literature review was performed to identify case reports and series with individual patient-level data describing EVT for intracranial GCA. The clinical course, therapeutic considerations, and technique of seven endovascular treatments in a single patient from the authors' experience are presented.ResultsThe literature review identified 9 reports of 19 treatments, including percutaneous transluminal angioplasty (PTA) with or without stenting, in 14 patients (mean age 69.6 ± 6.3 years). Out of 12 patients 8 (66.7%) with sufficient data had > 1 pre-existing cardiovascular risk factor. All patients had infarction on MRI while on glucocorticoids and 7/14 (50%) progressed despite adjuvant immunosuppressive agents. Treatment was PTA alone in 15/19 (78.9%) cases and PTA + stent in 4/19 (21.1%). Repeat treatments were performed in 4/14 (28.6%) of patients (PTA-only). Non-flow limiting dissection was reported in 2/19 (10.5%) of treatments. The indications, technical details, and results of PTA are discussed in a single illustrative case. We report the novel use of intra-arterial calcium channel blocker infusion (verapamil) as adjuvant to PTA and as monotherapy, resulting in immediate improvement in cerebral blood flow.ConclusionEndovascular treatment, including PTA with or without stenting or calcium channel blocker infusion, may be effective therapies in medically refractory GCA with intracranial stenosis.

BackgroundThere is limited "real-world" evidence examining treatment modalities and outcomes in patients with symptomatic peripheral arterial disease undergoing endovascular treatment of femoropopliteal (FP) in-stent restenosis (ISR).Materials and methodsWe compared outcomes in 2,895 patients from the XLPAD registry (NCT01904851) between 2006 and 2019 treated for FP ISR (n = 347) and non-ISR (n = 2,548) lesions. Primary endpoint included major adverse limb events (MALE) at 1 year, a composite of all-cause death, target limb repeat revascularization, or major amputation.ResultsISR patients were more frequently on antiplatelet (94.5% vs 89.4%, p=0.007) and statin (68.9% vs 60.3%, p=0.003) therapies. Lesion length was similar (ISR: 145 ± 99 mm vs. non-ISR: 142 ± 99 mm, p=0.55). Fewer treated ISR lesions were chronic total occlusions (47.3% vs. 53.7%, p=0.02) and severely calcified (22.4% vs. 44.7%, p < 0.001). Atherectomy (63.5% vs. 45.0%, p < 0.001) and drug-coated balloons (DCB; 4.7% vs. 1.7%, p < 0.001) were more frequently used in ISR lesions. The distal embolization rate was higher in ISR lesions (2.4% vs. 0.9%, p=0.02). Repeat revascularization (21.5% vs. 16.7%, p=0.04; Figure) was higher and freedom from MALE at 1 year was significantly lower (87% vs. 92.5%, p < 0.001) in the ISR group.ConclusionAtherectomy and DCB are more frequently used to treat FP ISR lesions. Patients with FP ISR have more intraprocedural distal embolization, higher repeat revascularization procedures, and lower freedom from MALE at 1 year.

BackgroundPoststent ballooning/angioplasty (post-SB) have been shown to increase the risk of stroke risk after transfemoral carotid artery stenting. With the advancement of transcarotid artery revascularization (TCAR) with dynamic cerebral blood flow reversal, we aimed to study the impact of post-SB during TCAR.MethodsPatients undergoing TCAR in the Vascular Quality Initiative between September 2016 and May 2019 were included and were divided into three groups: those who received prestent deployment angioplasty only (pre-SB, reference group), those who received poststent deployment ballooning only (post-SB), and those who received both prestent and poststent deployment ballooning (prepost-SB). Patients who did not receive any angioplasty during their procedure (n = 367 [6.7%]) were excluded because these represent a different group of patients with less complex lesions than those requiring angioplasty. Primary outcome was in-hospital stroke or death. Analysis was performed using univariable and multivariable logistic regression models.ResultsOf 5161 patients undergoing TCAR, 34.7% had pre-SB only, 25% had post-SB only, and 40.3% had both (prepost-SB). No differences in the rates of in-hospital and 30-day stroke, death, and stroke/death were observed among the three groups; in-hospital stroke/death in the pre-SB group was 1.4% (n = 25), post-SB 1.2% (n = 16), and prepost-SB 1.4% (n = 29; P = .92). However, patients undergoing post-SB and prepost-SB had higher rates of in-hospital transient ischemic attacks (TIA) (post-SB, 0.9%; prepost-SB, 1% vs pre-SB, 0.2%, P < .01) and postprocedural hypotension (16.6% and 16.8% vs 13.1%, respectively; P < .001). Post-SB also had longer operative times, as well as flow reversal and fluoroscopy times. On multivariable analysis, no association was seen between post-SB and the primary outcome of in-hospital stroke/death (post-SB odds ratio [OR], 0.88; 95% confidence interval [CI], 0.44-1.73; prepost-SB OR, 0.98; 95% CI, 0.57-1.70). Similarly, no significant differences were noted in terms of postprocedural hemodynamic instability and 30-day outcomes. However, post-SB and prepost-SB were associated with four times the odds of in-hospital TIA compared with pre-SB alone (post-SB OR, 4.24 [95% CI, 1.51-11.8]; prepost-SB OR, 4.76 [95% CI, 1.53-14.79]; P = .01). Symptomatic patients had higher rates of in-hospital stroke/death compared with their asymptomatic counterparts; however, there was no significant interaction between symptomatic status and ballooning in predicting the primary outcome.ConclusionsPost-SB was used in 65.3% of TCAR patients. This maneuver seems to be safe without an increase in the odds of postoperative in-hospital stroke/death. However, the increased rates of TIA associated with post-SB requires further investigation.

BackgroundPeripheral vascular devices (stents and balloons) coated with paclitaxel were developed to address suboptimal outcomes associated with percutaneous revascularization procedures of the femoral-popliteal arteries. In randomized controlled trials (RCT), paclitaxel-coated devices (PCD) provided increased long-term patency and a decreased need for repeat revascularization procedures compared with uncoated devices. This finding resulted in the adoption of their use for endovascular lower extremity revascularization procedures. However, in late 2018 a study-level meta-analysis showed increased all-cause mortality at 2 years or more after the procedure in patients treated with PCDs. This review examines the subsequent data evaluation following the publication of the meta-analysis.MethodsWe review the published responses of physicians, regulatory agencies, and patient advocates during 15-month period after the meta-analysis. We present the additional data gathered from RCTs that comprised the meta-analysis and safety outcomes from large insurance databases in both the United States and Europe.ResultsImmediately after the publication of the meta-analysis, concern for patient safety resulted in less PCD use, the suspension of large RCTs evaluating their use, and the publication of a letter from the U.S. Food and Drug Administration informing physicians that there was uncertainty in the benefit-risk profile of these devices for indicated patients and that the potential risk should be assessed before the use of PCDs. Review of the meta-analysis found that a mortality signal was present, but criticisms included that the evaluation was performed on study-level, not patient-level data, and the studies in the analysis were heterogenous in device type, paclitaxel doses, and patient characteristics. Further, the studies were not designed to be pooled nor were they powered for evaluating long-term safety. Clinical characteristics associated with a drug effect or causal relationship were also absent. Specifically, there was no dose response, no clustering of causes of death, and a lack of signal consistency across geographic regions. As more long-term data became available in the RCTs the strength of the mortality signal diminished and analysis of real-world use in large insurance databases, showed that there was no significant increase in all-cause mortality associated with PCD use.ConclusionsThe available data do not provide definitive proof for increased mortality with PCD use. A key observation is that trial design improvements will be necessary to better evaluate the risk-benefit profile of PCDs.

Pipeline embolisation device (PED) 'twisting' is an intra-operative complication that manifests with the appearance of a 'figure-8' in perpendicular planes on digital subtraction angiography. A twisted PED causes narrowing and/or complete occlusion of the vessel lumen and poses significant risks for thrombus formation and downstream ischaemia. Here, we present a case in which three unique PED implants become twisted during pipeline embolisation of a large fusiform internal carotid artery aneurysm. The twists were remediated by balloon angioplasty and a combination of techniques that allowed the PED to rotate and restore its original axis. Six-month and twelve-month follow-up angiography demonstrated complete aneurysm occlusion with preservation of the parent vessel, proving that proper remediation of PED twisting can still result in successful long-term outcomes.

BackgroundHookah smoking is marketed to youth as a harmless alternative to cigarettes. Although cigarette smoking acutely impairs endothelial function, the effect of smoking fruit-flavored hookah tobacco is unknown. Because charcoal traditionally is used to heat the hookah tobacco in the waterpipe, hookah smoke delivers tobacco toxicants and nicotine plus charcoal combustion products: not only carbon-rich nanoparticles, oxidants that may destroy nitric oxide and impair endothelial function, but also large amounts of carbon monoxide (CO), a putative vasodilator molecule.MethodsTo test the acute effect of hookah smoking on endothelial function, in young adult hookah smokers (n=30, age 26±1 years, mean±SE), we measured plasma nicotine, exhaled CO, and brachial artery flow-mediated dilation (FMD) before and after charcoal-heated hookah smoking. To remove the effect of charcoal combustion, the same measurements were performed when the same flavored hookah tobacco product was heated electrically (n=20). As a positive internal control, we studied age-matched cigarette smokers (n=15) who smoked 1 cigarette. To isolate the effect of the CO boost on FMD, hookah smokers (n=8) inhaled a 0.1% CO gas mixture to approximate their CO boost achieved with charcoal-heated hookah smoking.ResultsNicotine levels increased similarly with all types of smoking, whereas exhaled CO increased 9- to 10-fold more after charcoal-heated hookah than after either electrically heated hookah or cigarette smoking. FMD did not decrease after smoking charcoal-heated hookah but instead increased by +43±7% ( P

BackgroundDespite concern that cardiac surgery may adversely affect cognition, little evidence is available from population-based studies using presurgery data. With the use of the Health and Retirement Study, we compared memory change after participant-reported cardiac catheterization or cardiac surgery.MethodsParticipants were community-dwelling adults aged 65 years and older who self-reported cardiac catheterization or "heart surgery" at any biennial Health and Retirement Study interview between 2000 and 2014. Participants may have undergone the index procedure any time in the preceding 2 years. We modeled preprocedure to postprocedure change in composite memory score, derived from objective memory testing, using linear mixed effects models. We modeled postprocedure subjective memory decline with logistic regression. To quantify clinical relevance, we used the predicted memory change to estimate impact on ability to manage medications and finances independently.ResultsOf 3,105 participants, 1,921 (62%) underwent catheterization and 1,184 (38%) underwent operation. In adjusted analyses, surgery participants had little difference in preprocedure to postprocedure memory change compared with participants undergoing cardiac catheterization (-0.021 memory units; 95% confidence interval: -0.046 to 0.005 memory units, p = 0.12). If the relationship were causal, the point estimate for memory decline would confer an absolute 0.26% or 0.19% decrease in ability to manage finances or medications, respectively, corresponding to 4.6 additional months of cognitive aging. Cardiac surgery was not associated with subjective memory decline (adjusted odds ratio 0.93, 95% confidence interval: 0.74 to 1.18).ConclusionsIn this large, population-based cohort, memory declines after heart surgery and cardiac catheterization were similar. These findings suggest intermediate-term population-level adverse cognitive effects of cardiac surgery, if any, are likely subtle.

IntroductionAdvances in ST-segment elevation myocardial infarction (STEMI) management have involved improving the clinical processes connecting patients with timely emergency cardiovascular care. Screening upon emergency department (ED) arrival for an early ECG to diagnose STEMI, however, is not optimal for all patients. In addition, the degree to which timely screening and diagnosis are associated with improved time to intervention and postpercutaneous coronary intervention outcomes, under more contemporary practice conditions, is not known.MethodsWe present the methods for a retrospective multicentre cohort study anticipated to include 1220 patients across seven EDs to (1) evaluate the relationship between timely screening and diagnosis with treatment and postintervention clinical outcomes; (2) introduce novel measures for cross-facility performance comparisons of screening and diagnostic care team performance including: door-to-screening, door-to-diagnosis and door-to-catheterisation laboratory arrival times and (3) describe the use of electronic health record data in tandem with an existing disease registry.Ethics and disseminationThe completion of this study will provide critical feedback on the quality of screening and diagnostic performance within the contemporary STEMI care pathway that can be used to (1) improve emergency care delivery for patients with STEMI presenting to the ED, (2) present novel metrics for the comparison of screening and diagnostic care and (3) inform the development of screening and diagnostic support tools that could be translated to other care environments. We will disseminate our results via publication and quality performance data sharing with each site. Institutional ethics review approval was received prior to study initiation.

BACKGROUND:The prevalence, treatment and outcomes of balloon undilatable chronic total occlusions (CTOs) have received limited study. METHODS:We examined the prevalence, clinical and angiographic characteristics, and procedural outcomes of percutaneous coronary interventions (PCIs) for balloon undilatable CTOs in a contemporary multicenter US registry. RESULTS:Between 2012 and 2017 data on balloon undilatable lesions were available for 425 consecutive CTO PCIs in 415 patients in whom guidewire crossing was successful: 52 of 425 CTOs were balloon undilatable (12%). Mean patient age was 65 ± 10 years and most patients were men (84%). Patients with balloon undilatable CTOs were more likely to be diabetic (67 vs. 41%, P

We describe a novel technical approach to acute stroke illustrated by the case of a 41 year old male who presented with tandem right common carotid artery (CCA) and M1 occlusions. His NIHSS was 17 and Alberta stroke programe early CT score (ASPECTs) was 8. Thrombectomy initially proved challenging due to large volume CCA thrombus that repeatedly occluded the aspiration catheters. However, by inflating a balloon distally and pulling clot into the adjacent ECA, we were able to quickly restore distal contrast flow to the intracranial circulation and achieve Thrombolysis In Cerebral Infarction/Arterial Occlusive Lesion (TICI2C/AOL3) revascularization.

For patients with chronic thromboembolic pulmonary hypertension (CTEPH), the current standard of care involves surgical removal of fibro-thrombotic obstructions by pulmonary endarterectomy. While this approach has excellent outcomes, significant proportions of patients are not eligible for surgery or suffer from persistent/recurrent pulmonary hypertension after the procedure. The availability of balloon pulmonary angioplasty and the approval of the first medical therapy for use in CTEPH have significantly improved the outlook for patients ineligible for pulmonary endarterectomy. In this comprehensive review, we discuss the latest developments in the rapidly evolving field of CTEPH. These include improvements in imaging modalities and advances in surgical and interventional techniques, which have broadened the range of patients who may benefit from such procedures. The efficacy and safety of targeted medical therapies in CTEPH patients are also discussed, particularly the encouraging data from the recent MERIT-1 trial, which demonstrated the beneficial impact of using macitentan to treat patients with inoperable CTEPH, including those on background therapy. As the treatment options for CTEPH improve, hybrid management involving more than one intervention in the same patient may become a viable option in the near future.

Transplant vasculopathy is a form of slowly progressive rejection. The interventional cardiologist plays an important role in maintaining survival of this precious commodity by performing PCI. Everolimus drug eluting stents are highly effective and have relatively low occurrence of in-stent restenosis, but transplant vasculopathy continues to progress in a diffuse pattern.

Timely reperfusion is critical in acute ischemic stroke (AIS) and ST-segment-elevation myocardial infarction (STEMI). The degree to which hospital performance is correlated on emergent STEMI and AIS care is unknown. Primary objective of this study was to determine whether there was a positive correlation between hospital performance on door-to-balloon (D2B) time for STEMI and door-to-needle (DTN) time for AIS, with and without controlling for patient and hospital differences. Prospective study of all hospitals in both Get With The Guidelines-Stroke and Get With The Guidelines-Coronary Artery Disease from 2006 to 2009 and treating ≥10 patients. We compared hospital-level DTN time and D2B time using Spearman rank correlation coefficients and hierarchical linear regression modeling. There were 43 hospitals with 1976 AIS and 59 823 STEMI patients. Hospitals' DTN times for AIS did not correlate with D2B times for STEMI (ρ=-0.09; P=0.55). There was no correlation between hospitals' proportion of eligible patients treated within target time windows for AIS and STEMI (median DTN time

OBJECTIVES: We attempted to characterize the anatomy, function, clinical consequences, and treatment of right-sided anomalous coronary artery origin from the opposite side (R-ACAOS). BACKGROUND: Anomalous aortic origin of a coronary artery is a source of great uncertainty in cardiology. A recent study by our group found that ACAOS had a high prevalence (0.48%) in a general population of adolescents. METHODS: Sixty-seven consecutive patients were diagnosed with R-ACAOS according to a new definition: ectopic right coronary artery (RCA) with an intramural proximal course. We used intravascular ultrasonograms of the RCA to quantify congenital stenosis (in patients with potentially serious clinical presentations), and we correlated these measurements with clinical manifestations. RESULTS: All patients had some proximal intramural stenosis (mean 50%, range 16-83% of the cross-sectional area). Forty-two patients (62%) underwent stent-percutaneous coronary intervention (PCI) of R-ACAOS because of significant symptoms, positive stress tests, and/or significant stenosis. Stent-PCI was successful in all cases and correlated with improved symptoms at >1-year follow-up in 30 patients (71%) who were available for clinical follow-up. No ACAOS-related deaths occurred. The instent restenosis rate was 4/30 (13%) at a mean follow-up time of 5.0 years. CONCLUSIONS: This preliminary, but large and unprecedented observational study shows that cases angiographically identified as R-ACAOS universally feature an intramural aortic course but only occasionally severe stenosis on resting IVUS imaging. Our data suggest that stent-PCI with IVUS monitoring ameliorates patients presenting symptoms.

Coronary artery disease (CAD) is characterised by progressive atherosclerotic plaque leading to flow-limiting stenosis, while myocardial infarction (MI) occurs due to plaque rupture or erosion with abrupt coronary artery occlusion. Multiple inflammatory pathways influence plaque stability, but direct assessment of endothelial inflammation at the site of coronary artery stenosis has largely been limited to pathology samples or animal models of atherosclerosis. We describe a technique for isolating and characterising endothelial cells (ECs) and EC microparticles (EMPs) derived directly from the site of coronary artery plaque during balloon angioplasty and percutaneous coronary intervention. Coronary artery endothelial cells (CAECs) were identified using imaging flow cytometry (IFC), and individual CAEC and EMP expression of the pro-atherogenic adhesion molecule vascular cell adhesion molecule-1 (VCAM-1) was assessed immediately following angioplasty. Patients with MI registered 73 % higher VCAM-1 expression on their CAECs and 79 % higher expression on EMPs compared to patients with stable CAD. In contrast, VCAM-1 expression was absent on ECs in the peripheral circulation from these same subjects. VCAM-1 density was significantly higher on CAECs and EMPs among patients with MI and positively correlated with markers of myocardial infarct size. We conclude that increased VCAM-1 expression on EC and formation of EMP at the site of coronary plaque is positively correlated with the extent of vascular inflammation in patients with myocardial infarction.

Background and purposeHigh periprocedural complication rate is a key limitation of endovascular treatment of intracranial atherosclerotic disease (ICAD), despite potential risk reduction of recurrent stroke. Taking lessons from the Stenting and Aggressive Medical Management for Preventing Recurrent Stroke in Intracranial Arterial Stenosis (SAMMPRIS) trial, targeting a selected patient population, we prospectively evaluated the feasibility and safety of tailored angioplasty and/or stenting for patients with ICAD.MethodsFrom November 2011 to October 2012, 158 patients with symptomatic ICAD caused by hypoperfusion combined with poor collateral flow were consecutively recruited into a prospective single center study. Patients were divided into three groups based on arterial access and lesion morphology: balloon mounted stent group (group BS) for smooth access and Mori A lesion, angioplasty plus self-expanding stent group (group AS) for tortuous access and Mori B or C lesion, and angioplasty group (group AG) for tortuous access and Mori A lesion. The primary endpoints were successful procedure rate and any vascular event within 30 days.ResultsOverall technical success rate was 96.3% (154/158). There were significant differences in the technical success rate: 89.7% (35/39) in group AG compared with 97.5% (79/81) in group BS and 100% (38/38) in group AS (p=0.042). The 30 day composite stroke, myocardial infarction, or death rate was 4.4% (7/158). Stroke within 30 days occurred in four patients in group BS and in three patients in group AS.ConclusionsIndividualized treatment of ICAD using tailored devices according to arterial access and lesion morphology was feasible and safe in symptomatic patients caused by hypoperfusion with poor collateral flow.

Stroke is the third leading cause of death in developed nations. Up to 88% of strokes are ischemic in nature. Extracranial carotid artery atherosclerotic disease is the third leading cause of ischemic stroke in the general population and the second most common nontraumatic cause among adults younger than 45 years. This article provides comprehensive, evidence-based recommendations for the management of extracranial atherosclerotic disease, including imaging for screening and diagnosis, medical management, and interventional management.

Cephalic arch stenosis is a common complication in maintenance hemodialysis (MHD) patients with brachial artery-cephalic vein fistulas and frequently leads to loss of the functioning brachial artery-cephalic vein fistula. There is paucity of conclusive data to guide appropriate management. We examined the risk of recurrence of cephalic arch stenosis after angioplasty compared to angioplasty after stent placement determined by angiography of the involved upper extremity over time in a contemporary cohort of MHD patients treated in two interventional nephrology practices from March 2008 through May 2011. We retrospectively identified 45 MHD patients with evidence of cephalic arch stenosis (age 60 ± 30 years, 45% men) on elective angiograms. The median number of days until another angioplasty was required decreased, starting with a median of 91.5 days after the first, 70.5 days after the second, 85 days after the third, and 56 days after the fourth. Angioplasty is associated with a faster rate of recurrence of cephalic arch stenosis. The placement of intravascular stent seems to prolong the patency compared to angioplasty alone. Clinical trials with a larger sample size will better elucidate the value and timing of angioplasty versus stent placement in cephalic arch stenosis.

Since the last World Symposium on Pulmonary Hypertension in 2008, we have witnessed numerous and exciting developments in chronic thromboembolic pulmonary hypertension (CTEPH). Emerging clinical data and advances in technology have led to reinforcing and updated guidance on diagnostic approaches to pulmonary hypertension, guidelines that we hope will lead to better recognition and more timely diagnosis of CTEPH. We have new data on treatment practices across international boundaries as well as long-term outcomes for CTEPH patients treated with or without pulmonary endarterectomy. Furthermore, we have expanded data on alternative treatment options for select CTEPH patients, including data from multiple clinical trials of medical therapy, including 1 recent pivotal trial, and compelling case series of percutaneous pulmonary angioplasty. Lastly, we have garnered more experience, and on a larger international scale, with pulmonary endarterectomy, which is the treatment of choice for operable CTEPH. This report overviews and highlights these important interval developments as deliberated among our task force of CTEPH experts and presented at the 2013 World Symposium on Pulmonary Hypertension in Nice, France. (J Am Coil Cardiol 2013;62:D92-9) ©2013 by the American College of Cardiology Foundation.

ObjectiveRandomized trials and retrospective data suggest that covered balloon-expandable (CBE) stents have better short-term patency compared with balloon-expandable bare-metal stents (BMSs) in the treatment of iliac artery disease. This study evaluated midterm outcomes of BMSs vs CBE stents placed in the common iliac artery (CIA) for aortoiliac occlusive disease.MethodsAll endovascular interventions for symptomatic peripheral arterial occlusive disease performed at a single institution from 2006 to 2012 were reviewed. Patients undergoing stent placement in the CIA segment were included in the analysis. Demographic data, TransAtlantic Inter-Society Consensus (TASC) classification, stent type, patency, and limb reinterventions were compared.ResultsFor treatment of de novo distal aorta or CIA stenosis, 254 procedures were performed in 162 patients. BMSs were used in 190 arteries; CBE stents were used in 64 arteries. There was no difference in age, gender, or TASC classification between the two groups. Mean follow-up was 22 ± 16 months. Primary patency, assisted patency, and secondary patency were significantly better in the BMS group. CIAs treated with covered stents were more likely at 1 year or longer to require repeated intervention (hazard ratio, 2.5; 95% confidence interval, 1.2-5.3; P = .009). TASC classification did not predict need for reintervention in either group. Multivariate analysis revealed dual antiplatelet therapy to be the only other factor to affect patency during long-term follow-up.ConclusionsIn this study, BMSs had significantly better patency compared with CBE stents for treatment of aortoiliac occlusive disease. A randomized trial comparing patency as well as restenosis rates with long-term follow-up is needed to determine if there is any benefit from use of covered stents in the aortoiliac segment.

BackgroundCurrent guidelines recommend ≤90 minutes from first medical contact to percutaneous coronary intervention (FMC2B) for ST-segment-elevation myocardial infarction (STEMI) patients. We evaluated the relationship between patient home distance from a percutaneous coronary intervention (PCI) center, prehospital electrocardiogram (ECG) use, and FMC2B time among patients with STEMI.MethodsWe performed a retrospective cohort study including all STEMI patients in the ACTION-Get With The Guidelines registry from July 1, 2008, to September 30, 2012, who were transported by ambulance to a PCI center. Patient home distance was defined as the driving distance from the patient's home zip code to the PCI center address. Distance was classified into tertiles, and linear regression was used to characterize the interaction between prehospital ECG use and patient home distance with respect to FMC2B time.ResultsOf the 29,506 STEMI patients, 19,690 (67%) received a prehospital ECG. The median patient home distance to the PCI center was 11.0 miles among patients with and 9.9 miles among those without a prehospital ECG. Prehospital ECGs were associated with a 10-minute reduction in the FMC2B time (P < .0001), which was consistent across distance tertiles (11 vs 11 vs 10 minutes). The association between prehospital ECGs and shorter FMC2B was attenuated by 0.8 minute for every 10-mile increase in distance (interaction P = .0002).ConclusionsPrehospital ECGs are associated with a 10-minute reduction in the FMC2B time. However, patient home distance from a PCI center does not substantially change this association.

Despite the introduction of antiproliferative drug-eluting stents, coronary heart disease remains the leading cause of death in the United States. In-stent restenosis and bypass graft failure are characterized by excessive smooth muscle cell (SMC) proliferation and concomitant myointima formation with luminal obliteration. Here we show that during the development of myointimal hyperplasia in human arteries, SMCs show hyperpolarization of their mitochondrial membrane potential (ΔΨm) and acquire a temporary state with a high proliferative rate and resistance to apoptosis. Pyruvate dehydrogenase kinase isoform 2 (PDK2) was identified as a key regulatory protein, and its activation proved necessary for relevant myointima formation. Pharmacologic PDK2 blockade with dichloroacetate or lentiviral PDK2 knockdown prevented ΔΨm hyperpolarization, facilitated apoptosis and reduced myointima formation in injured human mammary and coronary arteries, rat aortas, rabbit iliac arteries and swine (pig) coronary arteries. In contrast to several commonly used antiproliferative drugs, dichloroacetate did not prevent vessel re-endothelialization. Targeting myointimal ΔΨm and alleviating apoptosis resistance is a novel strategy for the prevention of proliferative vascular diseases.

ObjectiveRestenosis following endovascular treatment of the femoropopliteal segment is associated with the inflammatory response produced in the artery wall at the time of the procedure. Although local drug delivery to the superficial femoral and popliteal arteries promises improved patency, data are currently limited. We hypothesized that improved percutaneous delivery of an anti-inflammatory compound into the adventitia of the femoropopliteal at the time of endovascular treatment would be safe, feasible, and decrease the inflammatory response.MethodsThis was a prospective, investigator-initiated, phase I, first-in-man study testing the safety and feasibility of percutaneous adventitial delivery of dexamethasone. Following successful intervention, an adventitial microinfusion catheter was advanced over a 0.014-inch wire to the treated segment. Its microneedle (0.9 mm long × 140-μm diameter) was deployed into the adventitia to deliver dexamethasone (4 mg/mL) mixed with contrast agent (80:20 ratio), providing fluoroscopic visualization. The primary safety outcome measure was freedom from vessel dissection, thrombosis, or extravasation while the primary efficacy outcome was duplex-determined binary restenosis defined as a peak systolic velocity ratio >2.5.ResultsTwenty patients with Rutherford clinical category 2-5 enrolled in this study. The mean age was 66, and 55% had diabetes mellitus. Treated lesion length was 8.9 ± 5.3 cm, and 50% were chronic total occlusions. Eighty percent of treated lesions were in the distal superficial femoral or popliteal arteries. All lesions were treated by balloon angioplasty with provisional stenting (n = 6) for suboptimal result. Three patients were treated with atherectomy as well. A mean of 1.6 ± 1.1 mg (0.5 ± 0.3 mL) of dexamethasone sodium phosphate was injected per centimeter of lesion length. In total, a mean of 12.1 ± 6.1 mg of dexamethasone was injected per patient. The mean number of injections required per lesion was 3.0 ± 1.3 cm, minimum one and maximum six injections. There was 100% technical success of drug delivery and no procedural or drug-related adverse events. The mean Rutherford score decreased from 3.1 ± .7 (median, 3.0) preoperatively to .5 ± .7 at 6 months (median, 0.0; P < .00001). Over this same time interval, the index leg ankle-brachial index increased from .68 ± .15 to .89 ± .19 (P = .0003). The preoperative C-reactive protein in this study was 6.9 ± 8.5 indicating severe baseline inflammation, which increased to 14.0 ± 23.1 mg/L (103% increase) at 24 hours following the procedure. However, this increase did not reach statistical significance of P = .14. Two patients met the primary efficacy end point of loss of primary patency by reoccluding their treated segment of the index lesion during the follow-up period.ConclusionsAdventitial drug delivery via a microinfusion catheter is a safe and feasible alternative to intimal-based methods for adjunctive treatment in the femoropopliteal segment. The 6-month preliminary results suggest perivascular dexamethasone treatment may improve outcomes following angioplasty to the femoral and popliteal arteries, and support further clinical investigation of this approach.

PurposeTo compare the patency rates and clinical outcomes of balloon angioplasty vs. nitinol stent placement for patients with short (≤150 mm) as compared to long (>150 mm) femoropopliteal (FP) occlusive lesions.MethodsBetween 2006 and 2011, 254 patients (134 men; mean age 68 years) underwent FP angioplasty. The majority of patients (64%) were treated for critical limb ischemia. One hundred thirty-nine (55%) patients had short FP lesions ≤150 mm, while 115 patients had long FP lesions >150 mm. The mean lesion length was 78±43 mm in the short FP lesion group and 254±58 mm in the long FP lesion group. Duplex ultrasound follow-up with a peak systolic velocity ratio ≥2.0 was used to define restenosis.ResultsThe overall procedure success rate was 98%. One hundred forty-eight (58%) patients underwent stent placement. The mean number of stents deployed for treatment of short FP lesions was 1.0±0.4 vs. 2.0±0.7 for long FP lesions (p90% at 30 days but declined to 62% to 75% at 1 year.ConclusionBalloon angioplasty and stent placement result in similar patency rates and clinical outcomes for shorter to medium-length FP lesions. In comparison, stent placement in long FP lesions is associated with superior outcomes to balloon angioplasty, even when multiple stents are required. Procedure success and clinical improvement can be achieved in the majority of patients, but rates of restenosis remain high.

Background/objectivesStent underexpansion is a risk factor for in-stent restenosis and stent thrombosis. Existing techniques to optimize stent expansion are sometimes ineffective. The aim of this study was to evaluate the effectiveness and feasibility of Excimer Laser Coronary Angioplasty (ELCA) in improving stent expansion when high-pressure non-compliant balloon inflation was ineffective.Methods and resultsECLA ablation was performed at high energy during contrast injection and only within the underexpanded stent. The primary endpoint of successful laser dilatation was defined as an increase of at least 1mm(2) in minimal stent cross-sectional area (MSA) on IVUS or an increase of at least 20% in minimal stent diameter (MSD) by QCA, following redilatation with the same non-compliant balloon that had been unsuccessful prior to ELCA. Secondary endpoints were cardiac death, myocardial infarction (MI) and target lesion revascularization. Between June 2009 and November 2011, 28 patients with an underexpanded stent despite high-pressure balloon inflation were included. The mean laser catheter size was 1.2±0.4 (range 0.9-2.0mm) and a mean of 62±12mJ/mm(2) at 62±21hertz were required for optimal expansion. Laser-assisted stent dilatation was successful in 27 cases (96.4%), with an improvement in MSD by QCA (1.6±0.6mm at baseline to 2.6±0.6mm post-procedure) and MSA by IVUS (3.5±1.1mm(2) to 7.1±1.9mm(2)). Periprocedural MI occurred in 7.1%, transient slow-flow in 3.6% and ST elevation in 3.6%. During follow-up, there were no MIs, there was 1 cardiac-death, and TLR occurred in 6.7%.ConclusionsThe ELLEMENT study confirms the feasibility of ELCA with contrast injection to improve stent underexpansion in undilatable stented lesions.

OBJECTIVES: To determine in-hospital mortality differences in individuals with dementia and acute myocardial infarction (AMI) when using invasive coronary procedures. DESIGN: Retrospective cohort study. SETTING: 2009 Nationwide Inpatient Sample. PARTICIPANTS: Individuals admitted with a primary diagnosis of AMI (N = 631,734) to 1,045 hospitals in 44 states during 2009. MEASUREMENTS: Dementia status and procedural use of diagnostic catheterization, percutaneous intervention (PCI), and coronary artery bypass grafts (CABG) as indicated by International Classification of Diseases, Ninth Revision, codes. The primary outcome was in-hospital mortality. Using multivariable analysis adjusted for covariates, associations were made between coronary procedural use in individuals with dementia and in-hospital mortality. Additional multivariable analysis identified the association between utilization of coronary procedures and in-hospital mortality in AMI patients with dementia. RESULTS: Dementia diagnosis (n = 15,335) was associated with greater likelihood of in-hospital mortality (odds ratio (OR) = 1.22, 95% confidence interval (CI) = 1.15-1.29, P < .001) and less use of diagnostic catheterization (OR = 0.37, 95% CI = 0.35-0.40, P < .001), PCI (OR = 0.37, 95% CI = 0.35-0.40, P < .001), and CABG (OR = 0.19, 95% CI = 0.16-0.22, P < .001). There was less likelihood of in-hospital mortality in participants with dementia who received diagnostic catheterization (OR = 0.36, 95% CI = 0.16-0.78, P < .001), PCI (OR = 0.57, 95% CI = 0.47-0.70, P < .001), or CABG (OR = 0.22, 95% CI = 0.08-0.56, P < .001) than in those not receiving respective interventions. CONCLUSION: Dementia is a significant predictor of in-hospital mortality for hospitalized individuals with AMI and is associated with less use of invasive coronary procedures. Beyond differing care patterns for individuals with AMI and dementia, these results indicate that individuals with dementia are at substantially greater risk for in-hospital mortality when they do not receive procedural interventions.

Hodgkin's lymphoma (HL) comprises of 4% of malignancies diagnosed in children from birth to 14 years of age. While overall survival rates have increased, HL survivors can be at risk of late cardiovascular complications from radiotherapy. HL survivors with a history of mediastinal RT have been found to have an increased incidence of myocardial infarction, angina, congestive heart failure, and valvular disorders compared to the general population.A 33 year old female with a history of HL status post chemotherapy and mediastinal radiation 11 years ago became symptomatic with multivessel coronary artery disease with aggressive progression of her disease despite coronary bypass graft surgery, patch angioplasty of the left main coronary artery (LMCA) with an extracellular bioscaffold, and repeated percutaneous coronary intervention of the LMCA. She eventually underwent orthotopic heart transplant and did well postoperatively.Histopathological analysis of the explanted heart revealed a variety of sequelae of radiation arteritis, including thrombosis of both native vessels and arterial grafts, intimal hyperplasia and involvement of the bioscaffold in the left main coronary vasculature. The bioscaffold did not contribute significantly to the stenosis within the LMCA.Our case demonstrates an unusual indication for OHT due to severe refractory radiation induced CAD, as well the wide spectrum of the histopathologic manifestations of radiation induced arteritis.

ObjectiveThis meta-analysis was performed to assess the efficacy and safety of bivalirudin compared with unfractionated heparin or enoxaparin plus glycoprotein (GP) IIb/IIIa inhibitors in patients undergoing percutaneous coronary intervention (PCI).BackgroundPharmacotherapy for patients undergoing PCI includes bivalirudin, heparin, and GP IIb/IIIa inhibitors. We sought to compare ischemic and bleeding outcomes with bivalirudin versus heparin plus GP IIb/IIIa inhibitors in patients undergoing PCI.MethodsA literature search was conducted to identify fully published randomized trials that compared bivalirudin with heparin plus GP IIb/IIIa inhibitors in patients undergoing PCI.ResultsA total of 19,772 patients in 5 clinical trials were included in the analysis (9785 patients received bivalirudin and 9987 patients received heparin plus GP IIb/IIIa inhibitors during PCI). Anticoagulation with bivalirudin, as compared with heparin plus glycoprotein IIb/IIIa inhibitors, results in no difference in major adverse cardiovascular events (odds ratio [OR] 1.07, 95% confidence interval [CI] 0.96 to 1.19), death (OR 0.93, 95% CI 0.72 to 1.21), or urgent revascularization (OR 1.06, 95% CI 0.86 to 1.30). There is a trend towards a higher risk of myocardial infarction (OR 1.12, 95% CI 0.99 to 1.28) but a significantly lower risk of TIMI major bleeding with bivalirudin (OR 0.55, 95% CI 0.44 to 0.69).ConclusionIn patients who undergo PCI, anticoagulation with bivalirudin as compared with unfractionated heparin or enoxaparin plus GP IIb/IIIa inhibitors results in similar ischemic adverse events but a reduction in major bleeding.

Background and purposeThere were limited data on the long-term outcome of patients with symptomatic intracranial atherosclerotic stenosis ≥70% after Wingspan stenting. Using our Wingspan cohort data and the data from the Warfarin and Aspirin for Symptomatic Intracranial Atherosclerotic Disease (WASID) as a historical control, we tested the hypothesis that stenting provided no benefit over antithrombotic therapy alone for these high-risk patients.MethodsBetween January 2007 and February 2009, 100 consecutive patients with intracranial atherosclerotic stenosis ≥70% and symptoms within 90 days were enrolled into this prospective single-center Wingspan cohort study and followed up until the end of February 2010. Stenosis was measured per the WASID criteria. One-year risk of primary end point (any stroke or death within 30 days and ipsilateral ischemic stroke afterward) was compared with that of ipsilateral ischemic stroke in the WASID patients with ≥70% stenosis.ResultsThe stent placement success rate was 99%. All patients but 1 had clinical follow-up of ≥12 months. During a mean follow-up of 1.8 years, 9 patients developed primary end point events (5 within 30 days and 4 afterward). The 1-year risk of the outcome events was lower than that in similar WASID patients: 7.3% (95% CI, 2.0% to 12.5%) versus 18% (95% CI, 13% to 24%; P

A 57-year-old man with a history of coronary artery disease and placement of an implantable cardioverter-defibrillator presented at our emergency room with an anterior ST-elevation myocardial infarction. Cardiac catheterization revealed an acutely occluded left main coronary artery, which was revascularized successfully with a bare-metal stent. Periprocedurally, the patient received aspirin, clopidogrel, unfractionated heparin, and eptifibatide. The patient was discharged a week later, but he returned to the emergency room the same day with recurrence of severe chest pain. Repeat cardiac catheterization revealed an acutely occluded stent, and the patient underwent repeat bare-metal stent placement and readministration of eptifibatide. On the next day, the patient's platelet count dropped acutely to less than 12,000/mm3. A test for heparin-induced thrombocytopenia antibody was negative. After discontinuation of eptifibatide, the patient's platelet count gradually returned to normal, and he was later discharged from the hospital with no complications. Eptifibatide-induced acute thrombocytopenia is a known but rare adverse effect. We review the handful of case reports in the medical literature, with emphasis on the prevalence, observed clinical course, and recently proposed physiologic mechanisms that probably are responsible for this phenomenon.

BackgroundExtrinsic compression of the left main coronary artery (LMCA) by a pulmonary artery aneurysm (PAA) has become increasingly recognized as an etiology of angina in patients with pulmonary arterial hypertension (PAH). The purpose of this study was to assess the feasibility and efficacy of LMCA stenting in the treatment LMCA stenosis because of PAA.MethodsRetrospective analysis of data on patients with PAH who presented with angina and underwent percutaneous intervention of their LMCA compression because of PAA was performed.ResultsFive patients (age 51 ± 16 years, all female) with PAH presented with angina and underwent LMCA stenting between 2007 and 2009. Four had positive cardiac enzymes. LMCA compression because of a PAA was diagnosed in all patients with cardiac CT angiography after echocardiography demonstrated an enlarged pulmonary artery. LMCA stenting was successfully performed in all patients with resolution of angina and electrocardiographic abnormalities. After a mean follow-up of 16.6 ± 15.7 months (range of 5-39 months), patients remained angina free, no complications of the procedure were noted, and long term stent patency was confirmed in three of the five patients who underwent repeat cardiac CT angiography.ConclusionsLMCA stenting appears to be a feasible and durable option in patients who present with angina because of compression by PAA. This procedure was well tolerated and is of particular value given the increased surgical risk in patients with PAH.

ObjectivesTo evaluate the clinical outcomes in patients with chronic renal insufficiency (CRI) who undergo saphenous vein graft (SVG) intervention with drug-eluting stents (DES).BackgroundPatients with CRI have higher rates of major adverse cardiac events (MACE) after percutaneous revascularization. SVG intervention is associated with increased rates of MACE compared with percutaneous revascularization of native arteries. However, the impact of CRI on SVG intervention with DES has not been well delineated.MethodsConsecutive patients who underwent SVG intervention with DES at five medical centers from April 2003 to December 2007 were included in this analysis.ResultsA total of 172 patients, 39 patients with CRI and a serum creatinine > or =1.5 mg dL(-1), and 133 patients without CRI, underwent SVG intervention with DES. Patients with CRI were more often older, diabetic, and had a longer mean total stent length. At 1 year, patients with CRI had a higher MACE rate (35.9% vs. 15.8%, hazard ratio [HR] 2.48, 95% confidence interval [CI] 1.26-4.88, log rank P = 0.009), mainly driven by higher mortality (20.5% vs. 9.8%, HR 3.41, 95% CI 1.10-10.58, log rank P = 0.024). There was a trend toward higher rates of target vessel revascularization in the CRI group (21.8% vs. 10.3%, HR 2.42, 95% CI 0.94-6.24, log rank P = 0.059). Stent thrombosis rates were not different between patients with and without CRI (2.6% vs. 2.3%, P = 0.8). Multivariable analysis revealed that CRI was the only significant predictor of 1-year MACE (HR 2.2, 95% CI 1.1-4.3; P = 0.03).ConclusionsPatients with CRI who underwent SVG intervention with DES had higher risks of MACE and death compared with patients with preserved renal function. Further treatment strategies are needed in this high-risk group who undergo SVG intervention with DES.

Acute occlusion involving the unprotected left main coronary artery (ULMCA) is a clinically catastrophic event, often leading to abrupt and severe circulatory failure, lethal arrhythmias, and sudden cardiac death. Although coronary artery bypass grafting (CABG) is the standard of care for ULMCA disease in patients with stable ischemic heart disease, uncertainty surrounds the optimal revascularization strategy for patients with ST-elevation myocardial infarction (MI) and ULMCA occlusion who survive to hospitalization, and treatment guidelines in this setting are vague. Percutaneous coronary intervention (PCI) is technically feasible in most patients, has the advantage of providing more rapid reperfusion compared with CABG with acceptable short- and long-term outcomes, and is associated with a lower risk of stroke. PCI of the ULMCA should be considered as a viable alternative to CABG for selected patients with MI, including those with ULMCA occlusion and less than Thrombolysis In Myocardial Infarction flow grade 3, cardiogenic shock, persistent ventricular arrhythmias, and significant comorbidities. The higher risk of target vessel revascularization associated with ULMCA PCI compared with CABG is an acceptable tradeoff given the primary need for rapid reperfusion to enhance survival.

BackgroundAmerican Indians/Alaska Natives (AIAN) experience a high burden of cardiovascular disease with rates for fatal and nonfatal heart disease approximately twofold higher than the U.S. population.ObjectiveTo determine if disparities exist in cardiac procedure rates among AIAN compared to non-Hispanic whites hospitalized in California for ischemic heart disease defined as acute myocardial infarction or unstable angina.DesignCross-sectional study. EVENTS: A total of 796 ischemic heart disease hospitalizations among AIAN and 90971 among non-Hispanic whites in 37 of 58 counties in California from 1998-2002.MeasurementsCardiac catheterization, percutaneous cardiac intervention, and coronary artery bypass graft surgery procedure rates from hospitalization administrative data.Main resultsAIAN did not have lower cardiac procedure rates for cardiac catheterization and percutaneous cardiac intervention compared to non-Hispanic whites (unadjusted OR 1.00, 95% CI 0.87-1.16 and OR 1.04, 95% CI 0.90-1.20, respectively). Adjustment for age, sex, comorbidities, and payer source did not alter the results (adjusted OR 0.95, 95% CI 0.82-1.10 and OR 0.98, 95% CI 0.85-1.14, respectively). We found higher odds (unadjusted OR 1.36, 95% CI 1.09-1.70) for receipt of coronary artery bypass graft surgery among AIAN hospitalized for ischemic heart disease compared to non-Hispanic whites which after adjustment attenuated some and was no longer statistically significant (adjusted OR 1.26, 95% CI 1.00-1.58).ConclusionAIAN were not less likely to receive cardiac procedures as non-Hispanic whites during hospitalizations for ischemic heart disease. Additional research is needed to determine whether differences in specialty referral patterns, patients' treatment preferences, or outpatient management may explain some of the health disparities due to cardiovascular disease that is found among AIAN.

ObjectivesThe aim of this study was to compare outcomes after percutaneous coronary intervention (PCI) with sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in the treatment of cardiac allograft vasculopathy (CAV).BackgroundPCI in patients with CAV is associated with increased rates of restenosis compared with PCI in patients without CAV. There are no dedicated studies on the influence of different drug-eluting stents (DES) on the outcomes of patients with CAV.MethodsThis is a retrospective observational study of 108 consecutive patients with CAV who underwent PCI with SES and PES at UCLA Medical Center and University of Padova Medical Center between 2002 and 2008.ResultsBaseline characteristics were similar among SES (n = 68) and PES (n = 40) patients with the exception of older patients, larger minimal lumen diameter, and smaller diameter stenosis in the SES-treated patients. Angiographic follow-up at 1 year was high in the SES and PES groups (74% vs. 76%, p = 0.8). The SES and PES groups had similar binary restenosis rates (10% vs. 9%, p = 0.7), percent diameter stenosis (24 +/- 24% vs. 24 +/- 18%, p = 0.94), and late lumen loss (0.67 +/- 1.03 mm vs. 0.68 +/- 1.11 mm, p > 0.9). One-year clinical outcomes were not significantly different among CAV patients treated with either SES or PES (major adverse cardiac events: 10% vs. 15%, p = 0.5; death: 3% vs. 5%, p = 0.4; myocardial infarction: 3% vs. 5%, p = 0.4; target vessel revascularization: 4% vs. 8%, p = 0.3).ConclusionsIn patients who underwent PCI for CAV, both SES and PES were safe and effective with no significant differences in clinical and angiographic outcomes. Randomized clinical trials comparing different DES with longer follow-up are necessary to identify the optimal treatment strategy for patients with CAV.

BackgroundReports of stent thrombosis and death in patients who have received drug-eluting stents (DES) have provoked debate regarding their long-term safety. We investigated the specific causes of death in patients receiving DES at an academic tertiary-care center.MethodsA retrospective analysis of 1,023 consecutive patients who underwent percutaneous coronary intervention (PCI) with DES from 2003 to 2006 at UCLA Medical Center was performed. Dates and cause of death were obtained by reviewing the patient's medical record, contacting the patient's doctor, or accessing the Social Security Death Index and obtaining copies of death certificates at the Los Angeles County Registrar-Recorder/County Clerk office. If the cause of death could not be determined, it was reported "unknown."ResultsAt a mean follow up of 2.9 +/- 1.3 years, 96 patients who underwent PCI with DES died during the analysis (9.4% mortality). The mean duration between index PCI and death was 331 +/- 324 days. The cause of death was unknown in 9 patients, thus the analysis was based upon 87 patients. There were similar number of cardiac (n = 44) and non-cardiac deaths (n = 43). The risk of PCI-related death was 1.3% (13/1023), which included 11 patients (1.1%) who died from stent thrombosis. Fourteen patients (1.4%) who presented with myocardial infarction (MI) and underwent PCI died, and 14 patients (1.4%) died from heart failure. Non-cardiac deaths included cancer, infection, respiratory failure and a cerebrovascular event. Age, chronic renal insufficiency, presentation with MI, chronic obstructive pulmonary disease, history of cerebrovascular event, orthotopic heart transplantation and left ventricular ejection fraction were significantly associated with increased mortality.ConclusionsCardiac and non-cardiac causes of death contributed similarly to mortality in patients who underwent PCI with DES at a large tertiary care center that manages high-risk patients. Overall PCI-related death and stent thrombosis causing death were low. The majority of deaths occurred in patients after hospital discharge. The majority of patients who died in the hospital presented with acute MI and were in critical condition on presentation.

ObjectivesThis study sought to retrospectively appraise the incidence and management of restenosis after drug-eluting stent (DES) implantation for unprotected left main (ULM) disease.BackgroundThe promising role of DES for ULM has been reported. However, no detailed data are available on subsequent restenosis.MethodsFrom the total sample of patients with ULM treated with DES, we identified those presenting with angiographic ULM restenosis. The primary end point was the long-term rate of major adverse cardiac events (MACE), that is, death, myocardial infarction (MI), or target lesion revascularization (TLR). We also adjudicated stent thrombosis according to the Academic Research Consortium.ResultsPost-DES restenosis in ULM occurred in 70 of 718 patients (9.7%). Of these, 59 (84.3%) were treated percutaneously (34 [48.6%] with additional DES, 22 [31.4%] with standard or cutting balloons, 2 [2.9%] with rotational atherectomy, and 1 [1.4%] with a bare-metal stent), whereas 7 (10%) patients underwent bypass surgery and 4 (5.7%) were treated medically. In-hospital MACE included no periprocedural MI and only 1 (1.4%) death. After 27.2 +/- 15.4 months, MACE occurred cumulatively in 18 (25.7%) patients, with death in 4 (5.7%), MI in 2 (2.9%), and TLR in 15 (21.4%). Patients treated with medical, interventional, and surgical therapy had the following MACE rates, respectively: 50%, 25.4%, and 14.3%. Definite, probable, and possible stent thrombosis occurred in 0 (0%), 1 (1.4%), and 1 (1.4%) patient, respectively.ConclusionsDES restenosis in the ULM artery can be managed in most cases with a minimally invasive approach, achieving favorable early and late results.

ObjectivesPreliminary Investigation to the Angiographic Versus IVUS Optimization Trial is a single center prospective observational intravascular ultrasound (IVUS) guided stent implantation study assessing new criteria for optimal drug eluting stent (DES) deployment.BackgroundIVUS assessment of DES often reveals underexpansion and malapposition. Optimal stent deployment is currently poorly defined and previous criteria may not be suitable in long and complex lesions.MethodsOptimization was defined as achieving >/or 70% of the cross-sectional area (CSA) of the postdilation balloon. This criterion was applied in 113 complex lesions. The size of this balloon was calculated according to vessel media-to-media diameters at various sites inside the stented segment. The IVUS guided treated lesions were matched according to diabetes, vessel type, reference vessel diameter, minimum lumen diameter (MLD), and lesion length with a group of angiographic treated lesions to compare final MLD achieved.ResultsMean minimum stent CSA according to the postdilation balloon utilized was 4.62 mm(2), 6.26 mm(2), 7.87 mm(2), and 9.87 mm(2) for 2.5 mm, 3.0 mm, 3.5 mm, and 4 mm balloons, respectively. Final MLD (mm) was significantly larger in the IVUS compared to the angiographic-guided group (3.09 +/- 0.50 vs. 2.67 +/- 0.54; P < 0.0001). There were no procedural complications related to IVUS use.ConclusionsWe propose new IVUS criteria based on vessel remodeling that results in an increment in the final MLD, compared to angiographic guidance, which is much larger than any previously published study. This criterion seems to be safely achievable. A proposed randomized study (angiographic vs. IVUS optimization trial) has been launched to test these concepts.

BackgroundPatients with elevated white blood cell (WBC) counts who undergo percutaneous coronary intervention (PCI) are at increased risk for short- and long-term mortality as well as major adverse cardiac events (MACE). We assessed the relationship between elevated WBC counts and clinical events in patients who underwent PCI with drug-eluting stents (DES).MethodsOur retrospective study includes 878 consecutive patients who underwent both elective and emergent PCI with DES at the UCLA Medical Center. The cohort was divided into tertiles based upon the presenting WBC count: 2.8-6.3 x 109 cells/L (tertile 1 [T1]), 6.4-8.7 x 109 cells/L (tertile 2 [T2]), > or = 8.8 x 109 cells/L (tertile 3 [T3]).ResultsSurvival at 1 year was significantly different between all three tertiles, and was poorest in patients with WBC counts in T3 (93.9%-T1, 98.4%-T2, 87.3%-T3; p < 0.0001), while T2 had the highest survival rate at 1 year. Age, chronic renal insufficiency, chronic obstructive pulmonary disease, low WBC count in T1, elevated WBC count in T3 and presentation with myocardial infarction were identified as multivariable predictors for survival at 1 year.ConclusionBoth elevated and low WBC counts are associated with increased mortality and MACE at 1 year following PCI with DES. WBC count is an independent predictor of survival in patients who undergo PCI with DES implantation.

BackgroundPatients who present with myocardial infarction (MI) and unprotected left main coronary artery (ULMCA) disease represent an extremely high-risk subset of patients. ULMCA percutaneous coronary intervention (PCI) with drug-eluting stents (DES) in MI patients has not been extensively studied.MethodsIn this retrospective multicenter international registry, we evaluated the clinical outcomes of 62 consecutive patients with MI who underwent ULMCA PCI with DES (23 ST-elevation MI [STEMI] and 39 non-ST-elevation MI [NSTEMI]) from 2002 to 2006.ResultsThe mean age was 70 +/- 12 years. Cardiogenic shock was present in 24%. The mean EuroSCORE was 10 +/- 8. Angiographic success was achieved in all patients. Overall in-hospital major adverse cardiac event (MACE) rate was 10%, mortality was 8%, all due to cardiac deaths from cardiogenic shock, and one patient suffered a periprocedural MI. At 586 +/- 431 days, 18 patients (29%) experienced MACE, 12 patients (19%) died (the mortality rate was 47% in patients with cardiogenic shock), and target vessel revascularization was performed in four patients, all of whom had distal bifurcation involvement (two patients underwent repeat PCI and two patients underwent bypass surgery). There was no additional MI. Two patients had probable stent thrombosis and one had possible stent thrombosis. Diabetes [hazard ratio (HR) 4.22, 95% confidence interval (CI) (1.07-17.36), P = 0.04), left ventricular ejection fraction [HR 0.94, 95% CI (0.90-0.98), P = 0.005), and intubation [HR 7.00, 95% CI (1.62-30.21), P = 0.009) were significantly associated with increased mortality.ConclusionsPatients with MI and ULMCA disease represent a very high-risk subgroup of patients who are critically ill. PCI with DES appears to be technically feasible, associated with acceptable long-term outcomes, and a reasonable alternative to surgical revascularization for MI patients with ULMCA disease. Randomized trials are needed to determine the ideal revascularization strategy for these patients.

BackgroundCoronary artery bypass graft (CABG) surgery is performed because of anticipated survival benefit, improvement in quality of life, or both. We performed this study to explore variations in clinical indications for CABG surgery among California hospitals and surgeons.MethodsUsing California CABG Outcomes Reporting Program data, we classified all isolated CABG cases in 2003-2004 as having "probable survival enhancing indications (SEIs)", "possible SEIs" or "non-SEIs." Patient and hospital characteristics associated with SEIs were examined.ResultsWhile 82.9% of CABG were performed for probable SEIs, the range extended from 68% to 96% among hospitals and 51% to 100% among surgeons. SEI rates were higher among patients aged >or= 65 compared with those aged 18-64 (Adjusted Odds Ratio [AOR] > 1.29 for age groups 65-69, 70-74 and >or= 75; all p < 0.001), among Asians and Native Americans compared with Caucasians (AOR 1.22 and 1.15, p < 0.001); and among patients with hypertension, peripheral vascular disease, diabetes, cerebrovascular disease and congestive heart failure compared to patients without these conditions (AOR > 1.09, all p < 0.001). Variations in indications for surgery were more strongly related to patient mix than to surgeon or hospital effects (intraclass correlation [ICC] = 0.04 for hospital; ICC = 0.01 for surgeon).ConclusionCalifornia hospitals and surgeons vary in their distribution of indications for CABG surgery. Further research is required to identify the roles of market factors, referral patterns, patient preferences, and local clinical culture in producing the observed variations.

BackgroundDiabetics who undergo percutaneous coronary intervention (PCI) are at increased risk for death, myocardial infarction, repeat revascularization, and stent thrombosis.MethodsOur retrospective study includes 887 consecutive patients who underwent PCI with drug-eluting stents (DES) at UCLA Medical Center. The cohort was divided into four groups: group 1, no diabetes and no acute coronary syndrome (ACS); group 2, no diabetes and ACS; group 3, diabetes and no ACS; group 4, diabetes and ACS.ResultsSurvival at 1 year was the lowest in diabetics who presented with ACS (90% in diabetics with ACS, 95% in diabetics without ACS, 95% in non-diabetics with ACS, and 96% in the non-diabetics without ACS, P = 0.03). At 1 year, age, diabetes, chronic renal insufficiency, ejection fraction, and myocardial infarction were identified as independent predictors for mortality.ConclusionIn the DES era, diabetics who undergo PCI for ACS continue to have an excess risk of death and major adverse cardiac events at 1 year.

ObjectivesWe sought to compare percutaneous coronary intervention (PCI) with bare-metal stents (BMS) and drug-eluting stents (DES) for cardiac allograft vasculopathy (CAV).BackgroundCardiac allograft vasculopathy is a rapidly progressive form of atherosclerosis and is one of the main limitations to long-term survival after orthotopic heart transplantation. Percutaneous coronary intervention has been used as a palliative treatment option for CAV but is associated with worse clinical outcomes and greater rate of restenosis compared with PCI of native coronary arteries.MethodsBetween 1995 and 2007, data on 82 consecutive heart transplant patients who underwent PCI with BMS and DES at the University of California at Los Angeles Medical Center were retrospectively analyzed.ResultsA total of 82 lesions were treated with 98 BMS and 76 lesions were treated with 80 DES. Follow-up angiography was performed on 57 of 82 lesions (70%) treated with BMS and 58 of 76 (76%) treated with DES (p = 0.7) at a mean follow-up of 9.5 +/- 5.5 months for BMS and 12.6 +/- 8.2 months for DES (p = 0.02). Compared with BMS, DES was associated with a lower binary restenosis rate (12% vs. 30%, p = 0.02), lower percent diameter stenosis (24 +/- 20 vs. 34 +/- 36, p = 0.06), and less late lumen loss (0.24 +/- 0.75 mm vs. 0.82 +/- 1.03 mm, p = 0.01). No angiographic stent thrombosis was observed with DES.ConclusionsWhen compared with BMS, PCI with DES was safe and reduced the rate of angiographic restenosis in patients with CAV. A randomized clinical trial comparing BMS versus DES with longer follow-up is needed to identify the optimal long-term revascularization strategy in patients with CAV.