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Background: The multicenter, international, randomized, blinded, sham-controlled RADIANCE-HTN SOLO trial (A Study of the ReCor Medical Paradise System in Clinical Hypertension) demonstrated a 6.3 mm Hg greater reduction in daytime ambulatory systolic blood pressure (BP) at 2 months by endovascular ultrasound renal denervation (RDN) compared with a sham procedure among patients not treated with antihypertensive medications. We report 6-month results after the addition of a recommended standardized stepped-care antihypertensive treatment to the randomized endovascular procedure under continued blinding to initial treatment. Methods: Patients with a daytime ambulatory BP ≥135/85 mm Hg and Results: A total of 69/74 RDN patients and 71/72 sham patients completed the 6-month ambulatory BP measurement. At 6 months, 65.2% of patients in the RDN group were treated with the standardized stepped-care antihypertensive treatment versus 84.5% in the sham group ( P =0.008), and the average number of antihypertensive medications and defined daily dose were less in the RDN group than in the sham group (0.9±0.9 versus 1.3±0.9, P =0.010 and 1.4±1.5 versus 2.0±1.8, P =0.018; respectively). Despite less intensive standardized stepped-care antihypertensive treatment, RDN reduced daytime ambulatory systolic BP to a greater extent than sham (−18.1±12.2 versus −15.6±13.2 mm Hg, respectively; difference adjusted for baseline BP and number of medications: −4.3 mm Hg, 95% confidence interval, −7.9 to −0.6, P =0.024). There were no major adverse events in either group through 6 months. Conclusions: The BP-lowering effect of endovascular ultrasound RDN was maintained at 6 months with less prescribed antihypertensive medications compared with a sham control. Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT02649426.

Objectives In the PACE trial 5-year analysis evaluating use of ponatinib in patients with refractory chronic myeloid leukemia (CML) and Ph+ acute lymphoblastic leukemia, a 25% incidence of AOEs was identified (Cortes, Blood 2018) using Medical Dictionary for Regulatory Activities (MedDRA) preferred terms (PTs). We performed a retrospective review using a charter-based independent Adjudication Committee (AC) to better understand clinically relevant AOE rates in PACE. Methods The AC (3 cardiologists, 1 hematologist, and 1 neurologist) evaluated AOEs (identified using >500 terms) in PACE using established definitions developed by the American College of Cardiology/American Heart Association (ACC/AHA), US Food and Drug Administration (FDA), and Standardized Data Collection for Cardiovascular Trials Initiative (SCTI). The AC also reviewed patient profiles including event, severity, concomitant medication, and hospitalization data. These adjudicated results were compared with pre-adjudication MedDRA PT search results. The AC was blind to dose, dose modification, and investigator causality opinion. Events not associated with a cardiovascular etiology or that failed to meet the ACC/AHA, FDA, and SCTI definitions were determined by the AC not to be AOEs. Results This review included all 449 heavily pretreated patients with Ph+ leukemia enrolled in PACE (median age, 59 y; 47% female; 93% ≥2 tyrosine kinase inhibitors). At a median follow-up of 37.3 months, adjudicated AOEs occurred in 17.4% of the overall patient population compared with 24.7% pre-adjudication. The majority of the pre-adjudication serious AOEs were adjudicated as serious AOEs (20% pre-adjudication vs 16% adjudicated). The most common adjudicated AOE (>2%) was peripheral arterial occlusive disease. Exposure-adjusted incidence of newly occurring adjudicated AOEs decreased over time. Analyses by baseline risk factors demonstrated that patients with the following baseline risk factors had higher incidence rates of adjudicated AOEs than those without ischemic cardiac disease, hypertension, hypercholesterolemia, and diabetes. Conclusions Independent AC review of the PACE trial identified a lower rate of clinically relevant AOEs than previously reported, suggesting an earlier possible overestimation that may not accurately reflect the risk of AOEs with ponatinib. The ongoing ponatinib dose-ranging OPTIC study will further evaluate dose-dependent AOE incidence rates.

7550 Background: The final 5-year analysis of the PACE trial, which evaluated use of PON in pts with refractory chronic myeloid leukemia (CML) and Ph+ acute lymphoblastic leukemia, identified a 25% incidence of AOEs (Cortes, Blood 2018) from a search utilizing > 400 preferred terms (PTs) defined by MedDRA and related to vascular ischemia or thrombosis. We performed a retrospective review using an independent Endpoint Adjudication Committee (EAC) to better understand clinically relevant AOE rates in PACE. Methods: The EAC consisted of 3 cardiologists, 1 hematologist, and 1 neurologist to review AOEs (identified using > 500 terms) in PACE using American College of Cardiology/American Heart Association (ACC/AHA) definitions for major adverse cardiovascular events (MACE), and to review pt profiles including event, severity, concomitant medication, and hospitalization data. These results were compared with MedDRA PT search results. The EAC was blind to dose, dose modification, and investigator causality opinion. Results: The PACE review included 449 heavily pretreated pts with Ph+ leukemia (median age, 59 y; 47% female; 93% ≥2 tyrosine kinase inhibitors). With median follow-up 37.3 mo in all pts, AOEs were identified by MedDRA PT search in 25% of pts and EAC-verified in 17% (Table). In each category listed in the table, the EAC verification identified fewer AOEs and serious AOEs. Serious AOEs were identified by MedDRA PT search in 20% of pts and EAC-verified in 16%. Events that were not associated with a cardiovascular etiology or failed to meet the MACE definition set forth by the ACC/AHA were determined by the EAC not to be an AOE. Conclusions: The independent EAC review showed a lower rate of clinically relevant AOEs than was reported in PACE, suggesting an earlier possible overestimation that may not accurately reflect the risk of AOEs with PON. The ongoing PON dose-ranging OPTIC study will further evaluate the PON risk:benefit profile. Clinical trial information: NCT01207440 . [Table: see text]

Kidney injury is common in patients with cardiovascular disease.We determined whether blood measurement of kidney injury molecule-1 (KIM-1), would predict kidney outcomes in patients undergoing angiographic procedures for various indications.One thousand two hundred eight patients undergoing coronary and/or peripheral angiography were prospectively enrolled; blood was collected for KIM-1 measurement. Peri-procedural acute kidney injury (AKI) was defined as AKI within 48 hours of contrast exposure. Non-procedural AKI was defined as AKI beyond 48 hours. Development of chronic kidney disease (CKD) was defined as progression to an estimated glomerular filtration rate (eGFR)60 milliliters/minute/1.73 mDuring mean follow up of 4 years, peri-procedural AKI occurred in 5.0%, non-procedural AKI in 27.3%, and 12.4% developed new reduction in eGFR60 mL/min/1.73 m2. Higher KIM-1 concentrations were associated with prevalent comorbidities associated with risk in cardiovascular disease and worse left ventricular function. In adjusted analyses, elevated pre- and post-procedural KIM-1 concentrations predicted not only peri-procedural AKI (odds ratio [OR] 1.54, 95% confidence interval [CI] 1.09-2·18, P = .01 and OR 1.54, 95% CI 1.10-2.15, P = .01, respectively) and non-procedural AKI (hazard ratio [HR] 1·49, 95% CI 1·24-1·78, P .001 and HR 1.46, 95% CI 1.23-1.74, P .001, respectively), but also progression to CKD (OR 1.99, 95% CI 1.32-2.99, P = .001 and OR 2·02, 95% CI 1·35-3·03, P = .001, respectively).In a typical at-risk population undergoing coronary and/or peripheral angiography, blood concentrations of KIM-1 may predict incident peri-procedural and non-procedural AKI, as well as progression to CKD.

BackgroundPatients with diabetes mellitus (DM) are at substantial risk of developing peripheral artery disease (PAD). We recently developed a clinical/proteomic panel to predict obstructive PAD. In this study, we compare the accuracy of this panel for the diagnosis of PAD in patients with and without DM.Methods and resultsThe HART PAD panel consists of one clinical variable (history of hypertension) and concentrations of six biomarkers (midkine, kidney injury molecule-1, interleukin-23, follicle-stimulating hormone, angiopoietin-1 and eotaxin-1). In a prospective cohort of 354 patients undergoing peripheral and/or coronary angiography, performance of this diagnostic panel to detect ≥50% stenosis in at least one peripheral vessel was assessed in patients with (n=94) and without DM (n=260). The model had an area under the receiver operating characteristic curve (AUC) of 0.85 for obstructive PAD. At optimal cut-off, the model had 84% sensitivity, 75% specificity, positive predictive value (PPV) of 84% and negative predictive value (NPV) of 75% for detection of PAD among patients with DM, similar as in those without DM. In those with DM, partitioning the model into five levels resulted in a PPV of 95% and NPV of 100% in the highest and lowest levels, respectively. Abnormal scores were associated with a shorter time to revascularisation during 4.3 years of follow-up.ConclusionA clinical/biomarker model can predict with high accuracy the presence of PAD among patients with DM.Trial registration numberNCT00842868.

Contains fulltext : 196098.pdf (Publisher’s version ) (Open Access) BACKGROUND: Peripheral arterial disease (PAD) is a global health problem that is frequently underdiagnosed and undertreated. Noninvasive tools to predict the presence and severity of PAD have limitations including inaccuracy, cost, or need for intravenous contrast and ionizing radiation. HYPOTHESIS: A clinical/biomarker score may offer an attractive alternative diagnostic method for PAD. METHODS: In a prospective cohort of 354 patients referred for diagnostic peripheral and/or coronary angiography, predictors of >/=50% stenosis in >/=1 peripheral vessel (carotid/subclavian, renal, or lower extremity arteries) were identified from >50 clinical variables and 109 biomarkers. Machine learning identified variables predictive of obstructive PAD; a score derived from the final model was developed. RESULTS: The score consisted of 1 clinical variable (history of hypertension) and 6 biomarkers (midkine, kidney injury molecule-1, interleukin-23, follicle-stimulating hormone, angiopoietin-1, and eotaxin-1). The model had an in-sample area under the receiver operating characteristic curve of 0.85 for obstructive PAD and a cross-validated area under the curve of 0.84; higher scores were associated with greater severity of angiographic stenosis. At optimal cutoff, the score had 65% sensitivity, 88% specificity, 76% positive predictive value (PPV), and 81% negative predictive value (NPV) for obstructive PAD and performed consistently across vascular territories. Partitioning the score into 5 levels resulted in a PPV of 86% and NPV of 98% in the highest and lowest levels, respectively. Elevated score was associated with shorter time to revascularization during 4.3 years of follow-up. CONCLUSIONS: A clinical/biomarker score demonstrates high accuracy for predicting the presence of PAD.

Objectives The purpose of this study was to evaluate and compare outcomes of patients undergoing carotid artery stenting (CAS) for ipsilateral restenosis, after either previous CAS or carotid artery endarterectomy (CEA) (CAS-R group), with those of patients who had CAS performed for de novo carotid atherosclerotic stenosis (CAS-DN group). Background Therapeutic revascularization strategies to reduce stroke include CAS and CEA. Limited data exist concerning the outcomes of CAS in the setting of previous ipsilateral carotid revascularization. Methods Patients enrolled in the CARE (Carotid Artery Revascularization and Endarterectomy) registry who underwent CAS were identified and separated into 2 groups: those undergoing CAS after previous ipsilateral CEA or CAS (CAS-R group, n = 1,996) and those who had CAS performed for de novo atherosclerotic carotid stenosis (CAS-DN group, n = 10,122). We analyzed the clinical and procedural factors associated with CAS-R and CAS-DN between January 1, 2005, and October 8, 2012. Propensity score matching using 19 clinical and 9 procedural characteristics was used, yielding 1,756 patients in each CAS cohort. Results The primary endpoint composite of in-hospital death or stroke or myocardial infarction (MI) occurred less often in the CAS-R compared with CAS-DN patients (1.9% vs. 3.2%; p = 0.019). In-hospital adverse cerebrovascular events (stroke or transient ischemic attack) occurred less frequently in the CAS-R cohort (2.2% vs. 3.6%; p Conclusions Patients who underwent CAS for restenosis after previous ipsilateral revascularization had lower periprocedural adverse event rates and comparable 30-day adverse event rates compared with CAS for de novo carotid artery stenosis.

Background & Purpose Embolic protection devices (EPD) may provide a mechanism to reduce peri-procedural strokes. They are advocated by consensus guidelines and mandated for Medicare reimbursement. However, outcomes data remain mixed. We aimed to characterize the population of patients undergoing unprotected carotid artery stenting (CAS) and assess the utility of distal filter EPD (F-EPD) in elective CAS. Methods We analyzed patients enrolled in the CARE Registry® undergoing CAS between May, 2005 and January, 2012. We assessed the relationship between distal F-EPD use versus no use (No-EPD) and the composite of in-hospital death or stroke (MAE) in unadjusted and 1:3 propensity-matched analyses. Results Embolic protection was not attempted in a total of 579 out of 13,263 cases performed (4.4%). Patients in the No-EPD group had worse preprocedure neurologic risk factors including higher rates of acute evolving stroke, prior TIA/stroke, symptomatic lesion status, spontaneous carotid artery dissection, and use of general anesthesia intraprocedurally (all Standardized Differences{sd} >10). After exclusion of nonelective cases there was no significant difference in MAE between the No-EPD and F-EPD groups (1.6% vs. 2.3%, sd = 4.72). Additionally, after propensity matching, rates of MAE did not differ between the No-EPD (n = 355) and F-EPD (n = 1065) groups (1.7% vs. 2.5%, sd = 5.87). Conclusions Patients selected to undergo unprotected CAS in contemporary practice have high rates of adverse preprocedure neurologic risk factors. Our propensity-matched analysis did not demonstrate evidence of significant benefit or harm associated with use of F-EPD in elective CAS patients. © 2013 Wiley Periodicals, Inc.

The objective of this study was to analyze the use of sirolimus-eluting stent (SES) placement for the treatment of renal artery in-stent restenosis (RA-ISR). The optimal treatment of RA-ISR has not been fully elucidated to date. We retrospectively analyzed consecutive patients from our institution who underwent treatment of RA-ISR with a SES from May 2004 to June 2006. Using duplex ultrasound, RA-ISR (> 60% diameter) was determined by peak systolic velocity (PSV) > 300 cm/s and renal aortic ratio (RAR) > 4.0. Renal function (creatinine) and blood pressure were measured at baseline and follow-up. SESs were implanted in 16 patients (22 renal arteries) during the study period. The study cohort was predominantly female (75%) with a mean age of 68 ± 12 years. RA-ISR was treated with SESs with a mean diameter of 3.5 mm and mean length of 17.9 ± 3.8 mm. The mean post-dilation balloon diameter was 4.8 ± 0.6. The baseline renal artery PSV was 445 ± 131 cm/s with a mean RAR of 5.0 ± 1.6. Follow-up information was available in 21 renal arteries. During a median follow-up of 12 months (range: 9—15 months), 15 renal arteries (71.4%) developed recurrence of ISR by ultrasonographic criteria. Univariate analysis revealed that female sex was an independent predictor of recurrence of ISR after SES implantation ( p < 0.05). In conclusion, placement of a SES for the treatment of ISR in renal arteries is associated with high initial technical success but significant restenosis on duplex ultrasonography at follow-up.

Department of Interventional Cardiology and Vascular Medicine, Massachusetts General Hospital, Boston, Massachusetts, USACASE PRESENTATIONA 39 year old male chef with previous right aorto-renalartery surgical reimplantation at age 8 for reportedcongenital renal artery stenosis presented to an outsidehospital with gastroenteritis including symptoms ofabdominal pain, nausea, diarrhea and vomiting. Pastmedical history apart from previous surgery for congenitalrenal artery stenosis was unremarkable. He was an activetobacco user of one pack per day for the previous20 years. There was no family history of prematurecoronary disease. Examination revealed a blood pressureof 210/100 mmHg, heart rate of 88 beats per minute andrespiratory rate of 16 per minute. Blood pressurerecordings were equal in both upper limbs. The radial,brachial, femoral and distal lower limb pulses weresymmetrical and of normal volume. No bruits wereaudible over the carotid, subclavian or femoral arteries.The remainders of the cardiac, respiratory and abdominalexaminations were unremarkable apart from a surgicalscar as a result of previous renal artery surgery.Medications included nifedipine 90mg and enalapril20mg had been started one month earlier for worseninghypertension. Laboratory profile on admission is shown in(Table 1).

Management of large bore arterial access sites often represents a challenge during interventional procedures, and usually requires prolonged manual compression, though suture-mediated closure techniques have been described. We report our experience in using the Mynx vascular closure device to close a 14 French femoral arteriotomy in two patients undergoing percutaneous balloon aortic valvuloplasty.

A 68-year-old man was admitted to the hospital because of a syncopal episode, followed by hemiparesis and altered mental status. An electrocardiogram revealed ST-segment elevations in the anterolateral leads, and MRI of the brain revealed infarcts involving all vascular distributions. Transthoracic echocardiography showed hypokinesis of the left ventricle and a mobile echodensity in the left atrium. Angiography revealed occlusion of the left anterior descending coronary artery, both renal arteries, and the superior mesenteric artery. A diagnostic procedure was performed.

Background— Platelets participate in events that immediately precede acute myocardial infarction. Because platelets lack nuclear DNA but retain megakaryocyte-derived mRNAs, the platelet transcriptome provides a novel window on gene expression preceding acute coronary events. Methods and Results— We profiled platelet mRNA from patients with acute ST-segment–elevation myocardial infarction (STEMI, n=16) or stable coronary artery disease (n=44). The platelet transcriptomes were analyzed and single-gene models constructed to identify candidate genes with differential expression. We validated 1 candidate gene product by performing a prospective, nested case-control study (n=255 case-control pairs) among apparently healthy women to assess the risk of future cardiovascular events (nonfatal myocardial infarction, nonfatal stroke, and cardiovascular death) associated with baseline plasma levels of the candidate protein. Platelets isolated from STEMI and coronary artery disease patients contained 54 differentially expressed transcripts. The strongest discriminators of STEMI in the microarrays were CD69 (odds ratio 6.2, P P =0.002). Plasma levels of MRP-8/14 heterodimer were higher in STEMI patients (17.0 versus 8.0 μg/mL, P P trend P Conclusions— The platelet transcriptome reveals quantitative differences between acute and stable coronary artery disease. MRP-14 expression increases before STEMI, and increasing plasma concentrations of MRP-8/14 among healthy individuals predict the risk of future cardiovascular events.

Pseudoaneurysms of the ascending aorta are a potentially fatal condition that usually necessitates definitive surgical management. In this series of three cases, we describe the novel use of the Amplatzer® septal occluder device in percutaneously managing this problem. © 2006 Wiley-Liss, Inc.

PURPOSE OF REVIEW The anatomic diagnosis of renovascular disease is increasing in frequency due to the advent of sophisticated non-invasive imaging modalities such as MRA (Magnetic Resonance Angiography) and renal angiography at the time of cardiac catheterization. Despite this fact, the investigation and appropriate management of renovascular disease has remained a controversial topic. This review addresses the clinical syndromes associated with renal artery stenosis (RAS) and the published data guiding appropriate patient selection for revascularization. RECENT FINDINGS There is a growing literature in support of renal revascularization as an aid in improving anti-hypertensive control, preserving renal function, and easing the management of congestive heart failure. Meanwhile, technological advances have allowed intervention in an expanding pool of eligible patients. One such technology is the atheroembolic protection device, which may soon allow renal salvage in patients with significant baseline renal impairment that were previously denied intervention for fear of worsening renal function. SUMMARY The data reviewed herein helps to identify patients that will benefit from renal revascularization. Large-scale, randomized data further defining the role of renal revascularization and optimal patient selection is still needed.

In 1966, Dr. Trygve Aakhus touted the role of angiography in the evaluation of mesenteric ischemia. Eleven years later in 1977, Boley described the intra-arterial administration of papaverine to treat mesenteric ischemia. The 1st report of mesenteric angioplasty was published in 1980 by Gruntzig et al. During the past 31 years, percutaneous management of mesenteric vascular disease has expanded considerably. Though endovascular therapy in mesenteric disease is performed for aneurysmal, oncologic, traumatic, and hemorrhagic indications, the most common indication is the treatment of ischemic diseases. It has been estimated that 1 of 1,000 hospital admissions is due to intestinal ischemic disorders, which can be classified as chronic and acute mesenteric ischemia. In the general population, the incidence of chronic mesenteric ischemia is 1/100,000; however, in populations with known atherosclerotic disease, the prevalence is much higher. Chronic mesenteric ischemia is most frequently due to multivessel atherosclerotic arterial disease in the abdomen. In contrast, acute mesenteric ischemia can result from arterial embolism, arterial or venous thrombosis, or low cardiac output states complicated by profound mesenteric vasoconstriction.

The prevalence of atherosclerotic renal artery stenosis has been described in population-based, autopsy, and referred populations and has been summarized in multiple reviews. The prevalence is highest among patients with known atherosclerotic disease. For example, in 319 patients undergoing catheter-based angiography for aortic or peripheral atherosclerotic disease, >50 % stenosis of a renal artery was found in 38 % patients. The prevalence remains high for patients suspected to have coronary artery disease. In over 20,000 patients referred for coronary angiography across seven studies, the prevalence of >50 % renal artery stenosis by angiography ranged from 6.3 to 23 %. In the general population, the prevalence is lower but not insignificant. That is, in a study of 834 Medicare patients with a mean age of 77 years, nearly 7 % had a renal artery stenosis of >60 % by screening duplex ultrasonography.

The purpose of this study was to evaluate and compare outcomes of patients undergoing carotid artery stenting (CAS) for ipsilateral restenosis, after either previous CAS or carotid artery endarterectomy (CEA) (CAS-R group), with those of patients who had CAS performed for de novo carotid atherosclerotic stenosis (CAS-DN group).Therapeutic revascularization strategies to reduce stroke include CAS and CEA. Limited data exist concerning the outcomes of CAS in the setting of previous ipsilateral carotid revascularization.Patients enrolled in the CARE (Carotid Artery Revascularization and Endarterectomy) registry who underwent CAS were identified and separated into 2 groups: those undergoing CAS after previous ipsilateral CEA or CAS (CAS-R group, n = 1,996) and those who had CAS performed for de novo atherosclerotic carotid stenosis (CAS-DN group, n = 10,122). We analyzed the clinical and procedural factors associated with CAS-R and CAS-DN between January 1, 2005, and October 8, 2012. Propensity score matching using 19 clinical and 9 procedural characteristics was used, yielding 1,756 patients in each CAS cohort.The primary endpoint composite of in-hospital death or stroke or myocardial infarction (MI) occurred less often in the CAS-R compared with CAS-DN patients (1.9% vs. 3.2%; p = 0.019). In-hospital adverse cerebrovascular events (stroke or transient ischemic attack) occurred less frequently in the CAS-R cohort (2.2% vs. 3.6%; p0.001). However, there was no significant difference in the composite of death, stroke, or MI at 30 days between both groups.Patients who underwent CAS for restenosis after previous ipsilateral revascularization had lower periprocedural adverse event rates and comparable 30-day adverse event rates compared with CAS for de novo carotid artery stenosis.

Peripheral artery disease (PAD) is common and often unrecognized. Patients with PAD are at high-risk for adverse cardiovascular events. Management of lower extremity PAD has two components: aggressive treatment of cardiovascular risk factors as well as treatment of lower extremity symptoms. In some cases of carotid and renal artery disease, interventional treatment is performed in asymptomatic lesions with hopes of altering the natural disease history and reducing future events.

Background: The optimal treatment for renal artery in-stent restenosis (RAISR) is not well established. Reintervention with balloon angioplasty, cutting-balloon, or additional bare-metal or drug-eluting stents can achieve immediate angiographic success. However, recurrent RA-ISR rates are high regardless of treatment strategy. Initial success with PTFE-covered stents, which may block in-growth of neointima, has led to expanded use for ISR.

We thank Tanemoto et al.1 for their letter and agree on the importance of including other diagnoses of 'percutaneous transluminal renal angioplasty-resistant' renal artery stenosis, such as retroperitoneal fibrosis (RPF) and chronic aortitis, that we did not mention in our renal case report.

The Mynx vascular closure device (VCD) (AccessClosure, Inc., Mountain View, California) is used for extravascular closure of the common femoral artery (CFA) after diagnostic or interventional endovascular procedures. Although it is common clinical practice to re-puncture a CFA, for some VCDs, acute repuncture is discouraged, while for other VCDs the safety of direct re-puncture through a previously placed VCD is still in question. The objective of this preclinical study was to evaluate the acute performance of the Mynx device where direct re-puncture has occurred through the hydrogel sealant, followed by delivery of a second Mynx device to close the reaccess puncture site.Two ovine models with a total of 24 punctures (12 sets of puncture and re-puncture) were used for this study. Success was measured utilizing angiographic and observational endpoints.There was no evidence of hydrogel sealant prolapse into the artery, distal embolization of sealant following repuncture, groin site bleeding or hematoma. Successful hemostasis was achieved in all punctures (mean activated clotting time = 357 secs) with the exception of a minor (non-clinically significant) contrast extravasation in the tissue tract, which resolved with 2 minutes of adjunctive compression.Arterial re-puncture in an ovine model directly through a recently placed Mynx closure device and subsequent re-closure with a second Mynx device can be successfully accomplished.

21-year-old black man presented with acute onset of rightarm and shoulder swelling with associated pain one dayafter performing 100 push-ups. He had been previously healthyand active with no significant past medical history. In particular,he had no antecedent history of shoulder trauma or deep venousthrombosis. He was right-handed and played the cello up to 6hours a day. Physical examination on admission was notable foredema involving the right upper arm, shoulder, and infraclavic-ular region. Abduction of the right arm was restricted because ofpain. Jugular venous pressure was not elevated. No dilatedsuperficial or collateral veins were seen on the anterior chestwall. No pulse or neurological deficits were noted in the rightarm at baseline or with attempts at Adson maneuver (neckextension, head away from affected side, and a deep breath).Duplex ultrasound of the right upper extremity revealed acutenonocclusive thrombus in a dilated axillary vein (Figure 1). Thevein walls were partially compressed with external transducerpressure, and spontaneous Doppler flow was minimal withdelayed augmentation on forearm compression. No cervical ribwas seen on chest x-ray, and computerized tomography angiog-raphy of the chest showed no pulmonary emboli. Prothromboticscreen was negative for activated protein-C resistance, pro-thrombingenemutationG20210A,proteinSandCdeficiencies,antithrombin III deficiency, lupus anticoagulant, anticardiolipinantibodies, and hyperhomocysteinemia.The patient was anticoagulated with intravenous unfrac-tionated heparin on admission. His symptoms and edemagradually lessened over the ensuing 4 days. Contrast venog-raphy was performed with the intent to perform catheter-directed thrombolysis, mechanical thrombectomy, or both.Venography revealed patent right axillary and subclavianveins with no evidence of thrombus (Figure 2). Maturecollateral venous communications, however, were foundbetween the axillary and subclavian veins. An Adson maneu-ver performed during venography demonstrated dynamicobstruction of the axillary vein lateral to the thoracic inletwhile flow was still visualized through the venous collateralnetwork (Figure 3). The patient was discharged on oralanticoagulation therapy. Orthopedic opinion is pending forpossible musculoskeletal pathogenesis.Paget-Schroetter syndrome (effort-induced axillary-subclavian vein thrombosis) typically presents after vigorousactivity involving arm abduction, cervical extension, andshoulder depression, especially in the presence of a mechan-ical abnormality at the thoracic inlet where the vein iscompressed between a hypertrophied anterior scalene muscleor subclavius tendon and the first rib. It is postulated thatmicrotrauma to the venous vessel wall activates the coagula

Objectives: This study aimed to evaluate the efficacy and safety of argatroban during percutaneous interventions for peripheral arterial disease (PAD). Background: Endovascular interventions are commonly used in patients with peripheral arterial disease. Heparin is routinely administered during these procedures, but cannot be used in patients with a history of heparin-induced thrombocytopenia (HIT). Argatroban is an approved direct thrombin inhibitor for treatment of patients with HIT. There are currently few data on the efficacy and safety of argatroban during endovascular interventions for PAD. Methods: Patients who underwent endovascular interventions for PAD on argatroban between 2002 and 2005 were identified from out database. Efficacy was evaluated using a composite of death, urgent revascularization, and amputation, while safety was assessed by TIMI major bleeding during the index hospitalization. Results: A total of 48 patients undergoing lower extremity revascularization on argatroban were identified. Thirty two of these patients (67%) had antibody-confirmed HIT and the other 16 (33%) had suspected HIT. A mean dose of argatroban was 173.5 ± 143 μg/kg bolus, followed by a 10.7 ± 9.64 μg/kg/min infusion during the procedure. Twelve patients (25%) met the composite end point (two deaths, one urgent revascularization, nine amputations because of progressive peripheral arterial disease). TIMI major bleeding occurred in three (6%) patients. Conclusion: In patients with confirmed or suspected HIT undergoing endovascular intervention for PAD, argatroban appears to be effective and safe. A larger study is warranted to confirm these findings from a single center. © 2008 Wiley-Liss, Inc.

A 59-year-old female with a history of hypertension and hyperlipidemia presented with a two day history of escalating chest pain. Her ECG revealed evolving T wave changes in leads V1–V3; troponin levels were undetectable. She was treated with aspirin 325mg and unfractionated heparin for unstable angina. Cardiac catheterization demonstrated high-grade stenoses in the proximal and mid left anterior descending artery. Two bare metal stents were deployed and she was given a 600mg loading dose of clopidogrel. She was discharged to home on hospital day 3 on a regimen that included aspirin 325mg and clopidogrel 75mg daily. Two days after discharge, the patient returned to the ED with substernal chest pain and anterior ST-segment elevations on ECG. Emergent coronary angiography demonstrated occlusive thrombus within the proximal stent. Intravascular ultrasound (IVUS) confirmed adequate stent deployment without edge dissection. Following thrombectomy, two additional bare metal stents were inserted and all stents post-dilated at high-pressure. She reported full medication compliance. She was empirically reloaded with 300mg of clopidogrel and her dose increased to 150mg daily. A hypercoagulability workup was negative. Two days after her second hospital discharge, the patient returned with chest pain and anterior ST-segment elevations on ECG. Emergent angiography confirmed recurrent stent thrombosis. Repeat IVUS showed that the stents were fully expanded and well apposed without evidence of mechanical complication. Following thrombectomy, an additional bare metal stent was inserted. She was empirically started on heparin and continued on clopidogrel 150mg daily. Following discontinuation of peri-procedural eptifibatide, platelet response to aspirin and clopidogrel were assessed with the VerifyNow™ (Accumetrics, San Diego, CA) assay. She demonstrated an appropriate response to aspirin but was found to have 0–3% platelet inhibition to clopidogrel on successive testing. Her clopidogrel was replaced with ticlopidine and coumadin. Repeat platelet testing demonstrated modest platelet inhibition (17%) with ticlopidine. Cilostazol was added as a third antiplatelet agent and her coumadin was discontinued. She has had no subsequent cardiac events.

Accidental insertion of an arterial sheath is an uncommon but potentially serious complication of jugular venous catheterization. When the subclavian artery is inadvertently cannulated, sheath removal can be complicated by significant hemorrhage due to its incompressible location. We report a case of inadvertent insertion of an 8 French sheath into the subclavian artery, which was successfully removed and the puncture site sealed with a collagen-based vascular closure device (Angio-Seal STS Plus). This averted an otherwise emergent open surgical procedure to remove the sheath and repair the subclavian artery in a high-risk patient.

We would like to thank Dr Krishnan and colleagues for their interest in our work. They have raised additional limitations of our work and question whether platelets express myeloid-related protein-14 (MRP-14). Their caution is reasonable. However, we have provided additional evidence that MRP-14 …

Percutaneous endovascular interventions for peripheral arterial disease are indicated in carefully selected patients with favorable anatomy and associated clinical symptoms. Although endovascular therapy appears to be hemodynamically equivalent to other modalities in isolated iliac disease, this does not appear to be the case for infrainguinal disease, particularly when the disease is diffuse and extensive. Such disease in these beds can often be treated surgically, although there is an increasing role for percutaneous therapies, particularly in patients at higher surgical risk. Catheter-based therapy should be considered an integral part of comprehensive medical therapy in patients with lower extremity peripheral arterial disease. Embarking on an endovascular approach to therapy should involve a frank physician-patient discussion of the risks, benefits, and durability of the proposed procedure tailored to anatomic locale and patient-specific factors.

A 5-year-old boy with Williams syndrome (WS) presented with a history of diffuse recurrent obstructive vascular disease. At the age of 12 months, he underwent pericardial patch augmentation of the ascending aorta and pulmonary arteries. He subsequently required Dacron patch repair of the ascending aorta and aortic arch at 3 years of age. In the interim, he had undergone percutaneous transluminal angioplasty and stenting for recurrent peripheral pulmonary artery stenoses and aortic recoarctation. On routine follow-up, he was found to have worsening right ventricular hypertension associated with disparate lung perfusion on a nuclear perfusion scan. He was brought to the catheterization laboratory for further investigation. Angiography showed recurrent pulmonary artery in-stent restenosis and aortic recoarctation. Coronary …

Background The ability to identify peri-procedural complications or predict short and long-term adverse outcomes in patients undergoing cardiac or peripheral angiography is imperfect. Methods In a prospective single-center trial, 1251 subjects undergoing coronary and peripheral angiographic procedures ± intervention between 2008 and 2011 were enrolled to evaluate the use of cardiac and renal biomarkers for identifying peri-procedural events and predicting short and long-term events. Blood samples were taken immediately before and after the procedure. Clinical and angiographic characteristics were recorded. The primary end point is peri-procedural combined end point of major adverse cardiovascular events (MACE: death, myocardial infarction (MI), heart failure (HF), stroke, transient ischemic attack, peripheral arterial complication and cardiac arrhythmia). Secondary end points are assessed at peri-procedural, 30-day and 1-year, and include MACE and individual end points as well as renal complications including acute kidney injury (AKI) and worsening of chronic kidney disease. Extended follow-up of up to 6 years has also been completed. Results Data from the first 491 patients have been obtained with 190 patients experiencing at least one MACE at 1-year follow-up with the following number of patients experiencing at least one specified event; 80 deaths, 39 MI, 73 HF, 21 neurological events, 37 peripheral arterial complications and 59 arrhythmias; additionally there were 55 patients with AKI. Conclusions The CASABLANCA study will examine the role of novel biomarkers and metabolomics for predicting a wide range of cardiovascular, neurologic, and renal complications in patients undergoing angiography. Full results are expected in the latter half of 2014 ( ClinicalTrials.Gov # NCT00842868 ).