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Objective To assess the incidence of contrast-associated acute kidney injury (CAAKI) after repeated exposure to contrast material for computed tomography (CT) and conventional coronary angiography within short intervals. Methods We studied 651 patients enrolled in the CorE-64 (November 5, 2005–January 30, 2007) and CORE320 (October 21, 2009–August 17, 2011) multicenter studies. Participants with suspected obstructive coronary heart disease were referred for diagnostic cardiac catheterization and underwent coronary CT angiography for research before invasive angiography. Nonionic, low-osmolality iodinated contrast material was used for all imaging. Results The median age of the patients was 62 years, and 190 (29%) were women. Major risk factors for acute kidney injury were present in 277 of 651 (43%) patients. The median interval between CT imaging and invasive angiography was 3.1 days (interquartile range, 0.9-8.0 days). The median volume of contrast material was 100 mL for each test. In 16 (2.5%) of 651 patients, CAAKI developed. Of these cases, 1 occurred after the CT scan, whereas 6 were documented after invasive angiography (compared with post-CT creatinine concentration assessment). In 9 patients, CAAKI was found in comparing creatinine concentration after completion of both tests with baseline values (but not compared with post-CT imaging). Conclusion Acute kidney injury after repeated exposure to iodinated contrast media within a few days is uncommon even in a population of patients with highly prevalent risk factors. Withholding of clinically indicated contrast-enhanced imaging may therefore not be justified in this setting.

Introduction: Systolic blood pressure (BP) is an important risk factor for cardiovascular outcomes. However, non-invasive measures obtained using a standard rectangular cuff (RC) are accurate only when the width of the cuff is ~40% of the arm circumference (AC). This ideal Ratio (IR) is met for the medium standard rectangular cuff at an AC of 30 cm. Hypothesis: A tapered cuff (TC) designed to maintain the IR over a range of ACs more accurately measures systolic BP than does a standard rectangular cuff. Methods: Twenty-two measures of BP using the RC and the TC were compared in seven patients with ACs of 30 cm. In addition, twenty-seven measures of SBP using the RC and the TC were compared with radial artery pressures in 12 patients with clinically placed arterial lines and arm circumferences ranging from 24 cm to 38 cm. Results: When ACs were 30 cm, there was no significant difference between the RC and SC systolic pressures (mean ± SD difference of 1.3 mmHg ± 0.8, p=.78) and they correlated with one another, R 2 of 0.99. However, over a range of ACs, the RC systolic pressures significantly differed from the arterial pressures (mean difference ± SD of 11 ± 4 mmHg, p=.005), and did not correlate with the arterial readings (Panel A) , whereas the TC systolic pressures did not differ from the arterial pressures (mean difference ± SD of 2 ± 1.3 mmHg, p=.18) and did correlate with the arterial readings (Panel B). Conclusion: Systolic BPs obtained with a TC which maintains the IR over a continuous range of arm circumferences are more accurate than are those obtained with a RC.

To provide comparative prognostic information of coronary atherosclerotic plaque volume and stenosis assessment in patients with suspected coronary artery disease (CAD). We followed 372 patients with suspected or known CAD enrolled in the CORE320 study for 2 years after baseline 320-detector row cardiac CT scanning and invasive quantitative coronary angiography (QCA). CT images were analyzed for coronary calcium scanning (CACS), semi-automatically derived total percent atheroma volume (PAV), segment stenosis score (SSS), in addition to traditional stenosis assessment (≥ 50%) by CT and QCA for (1) 30-day revascularization and (2) major adverse cardiac events (MACE). Area under the receiver operating characteristic curve (AUC) was used to compare accuracy of risk prediction. Sixty percent of patients had obstructive CAD by QCA with 23% undergoing 30-day revascularization and 9% experiencing MACE at 2 years. Most late events (20/32) were revascularization procedures. Prediction of 30-day revascularization was modest (AUC range 0.67–0.78) but improved after excluding patients with known CAD (AUC range 0.73–0.86, p

Combined CT angiography and CT myocardial perfusion enables similar prediction of 2-year major adverse cardiovascular event–free survival, including the need for myocardial revascularization procedures, similar to that achieved with standard invasive coronary angiography and single photon emission CT perfusion imaging.

Background Prevention of adverse remodeling after myocardial infarction ( MI) is an important goal of stem cell therapy. Clinical trial results vary, however, and poor cell retention and survival after delivery likely limit the opportunity to exert beneficial effects. To overcome these limitations, we built an implantable intravascular bioreactor ( IBR ) designed to protect contained cells from washout, dilution, and immune attack while allowing sustained release of beneficial paracrine factors. Methods and Results IBR s were constructed using semipermeable membrane adhered to a clinical‐grade catheter shaft. Mesenchymal stem cell ( MSC ) viability in and paracrine factor release from IBR s were assessed in vitro and IBR biocompatibility and immune protection confirmed in vivo. In a porcine anterior MI model, IBR s containing 25 million allogeneic MSC s ( IBR ‐ MSCs ) were compared with IBR s containing media alone ( IBR ‐Placebo; n=8 per group) with adverse remodeling assessed by magnetic resonance imaging. Four weeks after MI , IBR ‐ MSCs had no significant change in end‐diastolic volume (+0.33±4.32 mL; P =0.89), end‐systolic volume (+2.14±4.13 mL; P =0.21), and left ventricular ejection fraction (−2.27±2.94; P =0.33) while IBR ‐Placebo had significant increases in end‐diastolic volume (+10.37±3.84 mL; P =0.01) and ESV (+11.35±2.88 mL; P =0.01), and a significant decrease in left ventricular ejection fraction (−5.78±1.70; P =0.025). Eight weeks after MI , adherent pericarditis was present in 0 of 8 IBR ‐ MSCs versus 4 of 8 IBR ‐Placebo ( P =0.02), suggesting an anti‐inflammatory effect. In a separate study, 25 million allogeneic pig MSC s directly injected in the peri‐infarct zone 3 days after MI (n=6) showed no significant benefit in adverse remodeling at 4 weeks compared with IBR ‐ MSCs . Conclusions MSC s deployed inside an implantable, removable, and potentially rechargeable bioreactor in a large animal model remain viable, are immunoprotected, and attenuate adverse remodeling 4 weeks after MI .

Fentanyl is a potent opiate commonly administered during cardiac catheterization procedures in North America.1 The question of whether fentanyl could have adverse consequences in patients undergoing percutaneous coronary intervention (PCI) is raised by recent research demonstrating that intravenous morphine significantly delays the absorption of oral P2Y12 platelet inhibitors.2 The presumed mechanism is slowed gastric emptying. The single-center PACIFY trial (Platelet Aggregation With Ticagrelor Inhibition and Fentanyl; ClinicalTrials.gov. Unique identifier: NCT02683707) randomized adults undergoing clinically indicated elective coronary angiography to receive the procedure with or without intravenous fentanyl.3 The study was approved by the Johns Hopkins Medicine Institutional Review Board, and all participants provided written informed consent. Eligible adults had not received P2Y12 inhibitors for 14 days before enrollment. Other exclusion criteria included preprocedural treatment with oral anticoagulants or opiates, platelet count

Background Ongoing advancements of coronary computed tomographic angiography (CTA) continue to challenge the role of invasive coronary angiography (ICA) as the gold standard for the evaluation of coronary artery disease (CAD). We sought to investigate the diagnostic accuracy of 320-slice CTA for detecting obstructive CAD in reference to ICA and nuclear myocardial perfusion imaging using single-photon emission computed tomography. Methods For the CORE320 study (Coronary Artery Evaluation Using 320-Row Multidetector Computed Tomography Angiography and Myocardial Perfusion), 381 patients at 16 centers underwent CTA, nuclear myocardial perfusion imaging by single-photon emission computed tomography, and ICA for the evaluation of CAD. Imaging studies were analyzed in blinded core laboratories, and a stenosis of ≥50% by quantitative coronary angiography was considered obstructive, whereas a stress difference score of ≥1 indicated inducible myocardial ischemia. The area under the receiver operating characteristic curve was used to evaluate diagnostic accuracy. Results Of 381 patients, 229 (60%) had obstructive CAD by quantitative coronary angiography. Diagnostic accuracy of CTA on a per-patient analysis revealed an area under the receiver operating characteristic curve of 0.90 (95% CI, 0.87–0.93). Per-vessel and per-segment analysis revealed lower area under the receiver operating characteristic curve of 0.87 (0.84–0.90) and 0.81 (0.78–0.83), respectively. Median radiation dose was lower for CTA versus ICA: 3.16 (interquartile range, 2.82–3.59) versus 11.97 (interquartile range, 7.60–17.8) mSv ( P P >0.05). Furthermore, accuracy for identifying patients who subsequently underwent clinically driven coronary revascularization also was similar for CTA (0.76 [0.71–0.81]) and ICA (0.78 [0.74–0.83]; P =0.20). Conclusions Contemporary CTA accurately identifies patients with obstructive CAD by ICA at lower radiation exposure; however, agreement is lower in vessel- and segment-level analyses. Both CTA and ICA perform similarly for predicting clinically driven revascularization and for detecting myocardial ischemia by myocardial perfusion imaging using single-photon emission computed tomography, suggesting that limitations by both CTA and ICA contribute to variability of stenosis quantification. Clinical Trial Registration URL: https://www.clinicaltrials.gov . Unique identifier: NCT00934037.

Background The combination of coronary CT angiography (CTA) and myocardial CT perfusion (CTP) is gaining increasing acceptance, but a standardized approach to be implemented in the clinical setting is necessary. Objectives To investigate the accuracy of a combined coronary CTA and myocardial CTP comprehensive protocol compared to coronary CTA alone, using a combination of invasive coronary angiography and single photon emission CT as reference. Methods Three hundred eighty-one patients included in the CORE320 trial were analyzed in this study. Flow-limiting stenosis was defined as the presence of ≥50% stenosis by invasive coronary angiography with a related perfusion defect by single photon emission CT. The combined CTA + CTP definition of disease was the presence of a ≥50% stenosis with a related perfusion defect. All data sets were analyzed by 2 experienced readers, aligning anatomic findings by CTA with perfusion defects by CTP. Results Mean patient age was 62 ± 6 years (66% male), 27% with prior history of myocardial infarction. In a per-patient analysis, sensitivity for CTA alone was 93%, specificity was 54%, positive predictive value was 55%, negative predictive value was 93%, and overall accuracy was 69%. After combining CTA and CTP, sensitivity was 78%, specificity was 73%, negative predictive value was 64%, positive predictive value was 0.85%, and overall accuracy was 75%. In a per-vessel analysis, overall accuracy of CTA alone was 73% compared to 79% for the combination of CTA and CTP ( P Conclusions Combining coronary CTA and myocardial CTP findings through a comprehensive protocol is feasible. Although sensitivity is lower, specificity and overall accuracy are higher than assessment by coronary CTA when compared against a reference standard of stenosis with an associated perfusion defect.

Background— Acute hospitalized heart failure (AHHF) is associated with 40% to 50% risk of death or rehospitalization within 6 months after discharge. Timely (before hospital discharge) risk stratification of patients with AHHF is crucial. We hypothesized that mechanical alternans (MA) and T-wave alternans (TWA) are associated with postdischarge outcomes in patients with AHHF. Methods and Results— A prospective cohort study was conducted in the intensive cardiac care unit and enrolled 133 patients (59.6±15.7 years; 65% men) admitted with AHHF. Surface ECG and peripheral arterial blood pressure waveform via arterial line were recorded continuously during the intensive cardiac care unit stay. MA and TWA were measured by enhanced modified moving average method. All-cause death or heart transplant served as a combined primary end point. MA was observed in 28 patients (25%), whereas TWA was detected in 33 patients (33%). If present, MA was tightly coupled with TWA. Mean TWA amplitude was larger in patients with both TWA and MA when compared with patients with lone TWA (median, 37 [interquartile range, 26–61] versus 22 [21–23] μV; P =0.045). After a median of 10-month postdischarge, 42 (38%) patients died and 2 had heart transplants. MA was associated with the primary end point in univariable Cox model (hazard ratio, 1.84; 95% confidence interval, 1.00–3.40; P =0.05) and after adjustment for left ventricular ejection fraction, New York Heart Association HF class, and implanted implantable cardioverter defibrillator/cardiac resynchronization therapy defibrillator (hazard ratio, 2.12 95% confidence interval, 1.13–3.98; P =0.020). TWA without consideration of simultaneous MA was not significantly associated with primary end point (hazard ratio, 1.42; 95% confidence interval, 0.77–2.64; P =0.260). Conclusions— MA is independently associated with outcomes in AHHF. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT01557465.

Joseph P. Drozda, Jr, MD, FACC, Chair Deepak L. Bhatt, MD, MPH, FACC Joseph G. Cacchione, MD, FACC Blair D. Erb, Jr, MD, FACC Thomas A. Haffey, DO, FACC Robert A. Harrington, MD, FACC[†††][1] Jerry D. Kennett, MD, MACC Richard J. Kovacs, MD, FACC Harlan M. Krumholz, MD, SM, FACC

To investigate the patterns and diagnostic implications of coronary arterial lesion calcification by CT angiography (CTA) using a novel, cross-sectional grading method, we studied 371 patients enrolled in the CorE-64 study who underwent CTA and invasive angiography for detecting coronary artery stenoses by quantitative coronary angiography (QCA). The number of quadrants involving calcium on a cross-sectional view for ≥ 30 and ≥ 50 % lesions in 4,511 arterial segments was assessed by CTA according to: noncalcified, mild (one-quadrant), moderate (two-quadrant), severe (three-quadrant) and very severe (four-quadrant calcium). Area under the receiver operating characteristic curve (AUC) were used to evaluate CTA diagnostic accuracy and agreement versus. QCA for plaque types. Only 4 % of ≥ 50 % stenoses by QCA were very severely calcified while 43 % were noncalcified. AUC for CTA to detect ≥ 50 % stenoses by QCA for non-calcified, mildly, moderately, severely, and very severely calcified plaques were 0.90, 0.88, 0.83, 0.76 and 0.89, respectively (P0.05). In 198 lesions with severe calcification, the presence or absence of a visible residual lumen by CTA was associated with ≥ 50 % stenosis by QCA in 20.3 and 76.9 %, respectively. Kappa was 0.93 for interobserver variability in evaluating plaque calcification. We conclude that calcification of individual coronary artery lesions can be reliably graded using CTA. Most ≥ 50 % coronary artery stenoses are not or only mildly calcified. If no residual lumen is seen on CTA, calcified lesions are predictive of ≥ 50 % stenoses and vice versa. CTA diagnostic accuracy for detecting ≥ 50 % stenoses is reduced in lesions with more than mild calcification due to lower specificity.

Background Total atherosclerotic plaque burden assessment by CT angiography (CTA) is a promising tool for diagnosis and prognosis of coronary artery disease (CAD) but its validation is restricted to small clinical studies. We tested the feasibility of semi-automatically derived coronary atheroma burden assessment for identifying patients with hemodynamically significant CAD in a large cohort of patients with heterogenous characteristics. Methods This study focused on the CTA component of the CORE320 study population. A semi-automated contour detection algorithm quantified total coronary atheroma volume defined as the difference between vessel and lumen volume. Percent atheroma volume (PAV = [total atheroma volume/total vessel volume] × 100) was the primary metric for assessment (n = 374). The area under the receiver operating characteristic curve (AUC) determined the diagnostic accuracy for identifying patients with hemodynamically significant CAD defined as ≥50% stenosis by quantitative coronary angiography and associated myocardial perfusion abnormality by SPECT. Results Of 374 patients, 139 (37%) had hemodynamically significant CAD. The AUC for PAV was 0.78 (95% confidence interval [CI] 0.73–0.83) compared with 0.84 [0.79–0.88] by standard expert CTA interpretation (p = 0.02). Accuracy for both CTA (0.91 [0.87, 0.96]) and PAV (0.86 [0.81–0.91]) increased after excluding patients with history of CAD (p 3 [161.8, 398.7]). Conclusions A semi-automatically derived index of total coronary atheroma volume yields good accuracy for identifying patients with hemodynamically significant CAD, though marginally inferior to CTA expert reading. These results convey promise for rapid, reliable evaluation of clinically relevant CAD.

Extraction of sterile leads remains a controversial area. The risks and benefits of abandoning a lead are largely unknown, whereas the risks of lead extraction are better studied. Lead management decisions need to be made on a patient-by-patient basis, with important input from the patient and family. This article presents several representative cases and reviews the major considerations in making the decision of whether or not to extract a sterile lead that has become either no longer needed or no longer functional.

Background— Appropriate clinical decisions concerning diagnosis and treatment of coronary artery disease rely on correct integration of data on coronary anatomy and myocardial perfusion. The purpose of this article is to introduce a new left ventricular segmentation model for improved alignment of coronary arterial segments and myocardial perfusion territories, designed for the CORE320 study. Methods and Results— CORE320 is a prospective, multicenter study with a primary objective to evaluate the diagnostic accuracy of 320-row detector computed tomography (CT) to detect coronary artery luminal stenosis and corresponding myocardial perfusion deficits in patients with suspected coronary artery disease compared with the gold standard of conventional coronary angiography and single-photon emission CT myocardial perfusion imaging. We describe a 19-coronary segment and 13-myocardial territory alignment model, its application in both standard and CT image data sets, and the adjudication process of the initial cohort of patients recruited for the CORE320 study. Adjudication committees reviewed the images of the first 101 gold standard and 107 CT data sets. On the basis of the presented model and rules, all cases for adjudication were correctly identified. During image review, 6 (5.9%) gold standard and 9 (8.4%) CT data sets needed further realignment not triggered by the algorithm. Conclusions— We present a vascular territory distribution model developed for the CORE320 multicenter study, which accounts for variability in coronary anatomy and potential myocardial perfusion territory overlap. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00934037.

Chronic cocaine use may lead to premature atherosclerosis, however, the prevalence of and risk factors for coronary artery disease in asymptomatic cocaine users have not been reported.Between August 2007 and June 2010, 385 African American chronic cocaine users aged 25 to 54 years were consecutively enrolled in a study to investigate the prevalence of CT angiographically-defined significant (≥ 50%) coronary stenosis and related risk factors. Sociodemographic, drug-use behavior, medical history and medication data were obtained by interview and confirmed by medical chart review. Clinical examinations were performed as well as extensive laboratory tests including those for fasting lipid profiles, HIV, high sensitivity C-reactive protein, and vitamin D. Contrast-enhanced coronary CT angiography was performed.Significant coronary stenosis was detected in 52 of 385 participants (13.5%). The prevalences were 12% and 30% in those with low risk and with middle-high risk Framingham score, respectively. In those with low risk scores, the prevalences of significant stenosis were 10% and 18% in those without and with vitamin D deficiency, defined as serum 25-(OH) vitamin D10 ng/mL (p=0.08). Multiple logistic regression analysis revealed that vitamin D deficiency (adjusted OR=2.18, 95% CI: 1.07-4.43) is independently associated with the presence of significant coronary stenosis after controlling for traditional risk factors.The study indicates that the prevalence of significant coronary stenoses is high in asymptomatic young and middle-aged African American chronic cocaine users. These findings emphasize the importance of aggressive reduction of risk factors, including vitamin D deficiency in this population.

Extraction of sterile leads remains a controversial area. The risks and benefits of abandoning a lead are largely unknown, whereas the risks of lead extraction are better studied. Lead management decisions need to be made on a patient-by-patient basis, with important input from the patient and family. This article presents several representative cases and reviews the major considerations in making the decision of whether or not to extract a sterile lead that has become either no longer needed or no longer functional.

Background Premature coronary artery disease (CAD) is a major concern in human immunodeficiency virus (HIV)-infected African Americans. The objectives of the study were to estimate the incidence of subclinical CAD, defined by the presence of coronary plaque and/or calcification on cardiac computed tomography (CT), and to identify the associated risk factors in this vulnerable population. Subjects and Methods Between August 2003 and September 2010, 188 HIV-infected African Americans without known, or symptoms of, CAD underwent cardiac CT. The subset without demonstrable disease underwent a second cardiac CT approximately 2 years later. The incidence of disease over that period and the effects of antiretroviral treatment and other known and hypothesized risk factors were investigated. Results Sixty-nine of these 188 African Americans had evidence of subclinical disease on the initial cardiac CT, confirming prior high prevalence reports. A second cardiac CT was performed on 119 African Americans without disease approximately 2 years later. The total person-years of follow-up was 284.4. Subclinical CAD was detected in 14 of these, yielding an overall incidence of 4.92/100 person-years (95% confidence interval, 2.69–8.26). Among the factors investigated, only male sex and vitamin D deficiency were independently associated with the development of subclinical CAD. The study did not find significant associations between CD4 count, HIV viral load, antiretroviral treatment use, or cocaine use and the incidence of subclinical CAD. Conclusions The incidence of subclinical CAD in African Americans with HIV infection is provocatively high. Larger studies are warranted to confirm the role of vitamin D deficiency in the development of CAD in HIV-infected African Americans.

Background. Growing evidence suggests that vitamin D deficiency Is associated with clinical coronary artery disease (CAD). The relationship between vitamin D deficiency and subclinical CAD in HIV-infected individuals is not well-characterized. Methods. Computed tomographic (CT) coronary angiography was performed using contrast-enhanced 64-slice multidetector CT imaging, and vitamin D levels and the presence of traditional and novel risk factor for CAD were obtained in 674 HIV-infected African American (AA) participants aged 25–54 years in Baltimore, MD, without symptoms/clinical evidence of CAD. Results. The prevalence of vitamin D deficiency (25-hydroxy vitamin D

Objectives The purpose of this study was to assess the impact of patient population characteristics on accuracy by computed tomography angiography (CTA) to detect obstructive coronary artery disease (CAD). Background The ability of CTA to exclude obstructive CAD in patients of different pre-test probabilities and in presence of coronary calcification remains uncertain. Methods For the CORE-64 (Coronary Artery Evaluation Using 64-Row Multidetector Computed Tomography Angiography) study, 371 patients underwent CTA and cardiac catheterization for the detection of obstructive CAD, defined as ≥50% luminal stenosis by quantitative coronary angiography (QCA). This analysis includes 80 initially excluded patients with a calcium score ≥600. Area under the receiver-operating characteristic curve (AUC) was used to evaluate CTA diagnostic accuracy compared to QCA in patients according to calcium score and pre-test probability of CAD. Results Analysis of patient-based quantitative CTA accuracy revealed an AUC of 0.93 (95% confidence interval [CI]: 0.90 to 0.95). The AUC remained 0.93 (95% CI: 0.90 to 0.96) after excluding patients with known CAD but decreased to 0.81 (95% CI: 0.71 to 0.89) in patients with calcium score ≥600 (p = 0.077). While AUCs were similar (0.93, 0.92, and 0.93, respectively) for patients with intermediate, high pre-test probability for CAD, and known CAD, negative predictive values were different: 0.90, 0.83, and 0.50, respectively. Negative predictive values decreased from 0.93 to 0.75 for patients with calcium score Conclusions Both pre-test probability for CAD and coronary calcium scoring should be considered before using CTA for excluding obstructive CAD. For that purpose, CTA is less effective in patients with calcium score ≥600 and in patients with a high pre-test probability for obstructive CAD.

Although there are multiple etiologies of a right atrial thrombus, the presence of a central venous catheter increases the risk for its development. Once diagnosed, an assessment of patient-specific factors will aid in dictating the appropriate management strategy. In cases of chronic disease or adherent thrombotic masses, thrombolytic therapy might not result in complete resolution of the clot burden and could lead to a devastating embolic event. Accordingly, we present a case of a right atrial thrombus not amenable to medical therapy that was removed only after concomitant utilization of an AngioVac Aspiration System (Vortex Medical, Norwell, MA) and percutaneous snare catheterization.

End-Stage Renal Disease Predicts Complications in Pacemaker and ICD Implants. Introduction: Patients with chronic kidney disease (CKD) have increased morbidity following invasive procedures. We hypothesized that patients with CKD have higher complication rates following device implantation than patients with normal renal function. Methods: We reviewed the medical records of patients undergoing ICD or pacemaker implantation from August 2004 to August 2007. The estimated glomerular filtration rate (GFR) was calculated using the Cockroft–Gault equation. Those with GFR ≥ 90 cc/min served as controls. The remainder was grouped according to American Kidney Foundation stages of CKD. Bleeding complications were defined as need for pocket exploration or blood transfusion; cardiac tamponade; or hematoma requiring pressure dressing, change in medications or prolonged hospitalization. Infection was defined as infection of the pocket or lead system, or development of bacteremia/sepsis within 60 days. Results: There were 82 bleeding complications (5.7%) and 7 infections (0.5%) temporally related to device implantation in 1,440 patients. End-stage renal disease (ESRD), defined as GFR < 15 mL/min or need for dialysis, was identified in 32 patients. Infection rates were significantly higher in patients with ESRD versus controls (12.5% vs 0.2%; P < 0.0001). A significant increase in bleeding complications was observed in ESRD versus controls (21.9% vs 3.2%, respectively; P

Background Management of oral anticoagulation in patients undergoing pacemaker (PPM) or implantable cardioverter-defibrillator (ICD) implantation remains controversial. Prior studies demonstrate that continuation of warfarin may be safer when compared with strategies requiring interruption and/or heparin bridging. Limited data from randomized trials exist. Objective We conducted a randomized trial to determine whether warfarin continuation is superior to warfarin interruption during PPM or ICD implantation. Methods Patients on oral anticoagulation referred for PPM or ICD implantation were randomized to warfarin continuation versus interruption. Patients randomized to warfarin interruption were further stratified into two groups based on their risk for thromboembolic events in the absence of warfarin. Moderate-risk patients were randomized to warfarin continuation versus warfarin interruption. High-risk patients were randomized to warfarin continuation versus warfarin interruption with heparin bridging. The primary combined outcome included thromboembolic events, anticoagulant-related complications, or any significant bleeding necessitating additional intervention or discontinuation of anticoagulation. Results We studied 100 patients (average age 70.8 years, 21% female, mean body mass index 28.4) who underwent 64 ICD and 36 PPM implantations. Fifty patients were assigned to continue warfarin. The randomized groups were well matched. Among patients randomized to warfarin interruption, there were two pocket hematomas, one pericardial effusion, one transient ischemic attack, and one patient who developed heparin-induced thrombocytopenia. No events were noted among patients continuing warfarin (P = .056). Conclusions While the results were not statistically significant, there was a trend toward reduced complications in patients randomized to warfarin continuation. This strategy should be considered in patients undergoing PPM or ICD implantation.

Background: Transvenous lead extraction patients tend to have multiple medical problems complicated by prolonged infections that may result in high-mortality rates following a successful procedure. Methods: All adult patients referred for lead extraction for infection over a 4-year period were included in this study. Mortality following the procedure was assessed using hospital records and the Social Security Death Index. Results: Indications for extraction were systemic infection (n = 34) and isolated pocket infection (n = 33). Of the 67 patients, 47 (70%) were still alive at follow-up (6–55 months). No patient died during or within 24 hours of the procedure, and two were sent to emergent surgery and did well. However, five died during prolonged hospitalizations, and two were discharged to hospice care and died shortly thereafter. The remaining 13 deaths occurred after discharge from the hospital at a mean interval of 15 months (range, 24 days to 35 months) following the procedure. Notably, six of seven patients who died in the hospital, and nine of 13 who died after discharge, had bacteremia as their indication for extraction, for an overall mortality risk of 44% in patients with systemic infection. Conclusions: True risk assessment for lead extraction patients is underestimated and may be related to the focus on the procedural risks, while the underlying illness and physiologic state may account for the excess mortality following a successful extraction. In most cases, the infected hardware contributed to the length and severity of the illness, and thus earlier consideration for extraction may be warranted. (PACE 2011; 32–36)

This study was designed to assess the risk of significant bleeding complications in patients receiving antiplatelet or anticoagulation medications at the time of implantable cardioverter-defibrillator (ICD) device implantation.Periprocedural management of antiplatelet or anticoagulation therapy at the time of device implantation remains controversial.We performed a retrospective chart review of bleeding complications in all patients undergoing ICD or pacemaker implantation from August 2004 to August 2007. Aspirin or clopidogrel use was defined as taken within 5 days of the procedure. A significant bleeding complication was defined as need for pocket exploration or blood transfusion; hematoma requiring pressure dressing or change in anticoagulation therapy; or prolonged hospitalization.Of the 1,388 device implantations, 71 had bleeding complications (5.1%). Compared with controls not taking antiplatelet agents (n = 255), the combination of aspirin and clopidogrel (n = 139) significantly increased bleeding risk (7.2% vs. 1.6%; p = 0.004). In patients taking aspirin alone (n = 536), bleeding risk was marginally higher than it was for patients taking no antiplatelet agents (3.9% vs. 1.6%, p = 0.078). The use of periprocedural heparin (n = 154) markedly increased risk of bleeding when compared with holding warfarin until the international normalized ratio (INR) was normal (n = 258; 14.3% vs. 4.3%; p0.001) and compared with patients receiving no anticoagulation therapy (14.3% vs.1.6%; p0.0001). There was no statistical difference in bleeding risk between patients continued on warfarin with an INRor =1.5 (n = 46) and patients who had warfarin withheld until the INR was normal (n = 258; 6.5% vs. 4.3%; p = 0.50).Dual antiplatelet therapy and periprocedural heparin significantly increase the risk of bleeding complications at the time of pacemaker or ICD implantation.

The diagnostic accuracy of CT angiography (CTA) for assessing coronary stent patency is modest. CT myocardial stress perfusion imaging (CTP) is an evolving technique that may enhance the diagnostic accuracy of cardiac CT to evaluate coronary stents. We tested this hypothesis using data from the

Background: Endovascular lead extraction is an important component of the management of patients with chronically implanted arrhythmia control devices. Although it is associated with the potential for significant morbidity and mortality, there is little information about its scope and practice. Methods: We surveyed 1,000 physician members of the Heart Rhythm Society via e-mail solicitation. Results: Of the 252 respondents (25%), 221 (88%) reported either performing extractions themselves (63%), or having privileges at a hospital where extractions are performed (25%). Electrophysiologists perform extractions at most sites (83%) but cardiac surgeons perform endovascular lead extraction at a significant minority of sites (20%). Most respondents report low annual volumes of extractions at their site: 15% reported 50 procedures/year. Thirty-six percent of respondents reported that extractions were done in the operating room (OR) with surgeon present or immediately available, 39% in the electrophysiology (EP) lab with surgeon and OR identified and available, and 25% in EP lab without a surgeon or OR identified. The overall risks of lead extraction were felt to be 1–5% of major complication and 0.5–1% of mortality, roughly in line with published data. Conclusions: While there is agreement as to the risk of major complication and death from lead extraction, the degree of surgical availability varies considerably. The new guidelines document recommends the ability to promptly initiate an emergent surgical procedure, and this should be an important goal for all extractionists. (PACE 2010; 33:721–726)

OBJECTIVE. Evaluations of stents by MDCT from studies performed at single centers have yielded variable results with a high proportion of unassessable stents. The purpose of this study was to evaluate the accuracy of 64-MDCT angiography (MDCTA) in identifying in-stent restenosis in a multicenter trial. MATERIALS AND METHODS. The Coronary Evaluation Using Multidetector Spiral Computed Tomography Angiography Using 64 Detectors (CORE-64) Multicenter Trial and Registry evaluated the accuracy of 64-MDCTA in assessing 405 patients referred for coronary angiography. A total of 75 stents in 52 patients were assessed: 48 of 75 stents (64%) in 36 of 52 patients (69%) could be evaluated. The prevalence of in-stent restenosis by quantitative coronary angiography (QCA) in this subgroup was 23% (17/75). Eighty percent of the stents were ≤ 3.0 mm in diameter. RESULTS. The overall sensitivity, specificity, positive predictive value, and negative predictive value to detect 50% in-stent stenosis visually using MDCT compared with QCA was 33.3%, 91.7%, 57.1%, and 80.5%, respectively, with an overall accuracy of 77.1% for the 48 assessable stents. The ability to evaluate stents on MDCTA varied by stent type: Thick-strut stents such as Bx Velocity were assessable in 50% of the cases; Cypher, 62.5% of the cases; and thinner-strut stents such as Taxus, 75% of the cases. We performed quantitative assessment of in-stent contrast attenuation in Hounsfield units and correlated that value with the quantitative percentage of stenosis by QCA. The correlation coefficient between the average attenuation decrease and ≥ 50% stenosis by QCA was 0.25 (p = 0.073). Quantitative assessment failed to improve the accuracy of MDCT over qualitative assessment. CONCLUSION. The results of our study showed that 64-MDCT has poor ability to detect in-stent restenosis in small-diameter stents. Evaluability and negative predictive value were better in large-diameter stents. Thus, 64-MDCT may be appropriate for stent assessment in only selected patients. © American Roentgen Ray Society.

A 27-year-old man with a double inlet left ventricle s/p a classic Fontan palliation and oversewing of a regurgitant tricuspid valve, transposition of the great arteries, and a left persistent superior vena cava (LSVC) underwent pacemaker implantation via the LSVC (Medtronic 4068), with the …

Background— Establishing the diagnosis of coronary artery disease (CAD) in symptomatic patients allows appropriately allocating preventative measures. Single-photon emission computed tomography (CT)–acquired myocardial perfusion imaging (SPECT-MPI) is frequently used for the evaluation of CAD, but coronary CT angiography (CTA) has emerged as a valid alternative. Methods and Results— We compared the accuracy of SPECT-MPI and CTA for the diagnosis of CAD in 391 symptomatic patients who were prospectively enrolled in a multicenter study after clinical referral for cardiac catheterization. The area under the receiver operating characteristic curve was used to evaluate the diagnostic accuracy of CTA and SPECT-MPI for identifying patients with CAD defined as the presence of ≥1 coronary artery with ≥50% lumen stenosis by quantitative coronary angiography. Sensitivity to identify patients with CAD was greater for CTA than SPECT-MPI (0.92 versus 0.62, respectively; P P P P Conclusions— CTA is more accurate than SPECT-MPI for the diagnosis of CAD as defined by conventional angiography and may be underused for this purpose in symptomatic patients. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00934037.

Objectives Clinical and epidemiological evidence suggests that cocaine use is associated with an increased risk of premature atherosclerosis. The objectives of this study were to explore (1) whether cocaine abstinence is associated with a reduced marker of endothelial dysfunction, (2) whether cocaine abstinence is associated with a slower coronary plaque progression, and (3) whether reduction in cocaine use is associated with a reduced marker of endothelial dysfunction in African American chronic cocaine users with contrast-enhanced coronary CT angiography-confirmed less than 50% coronary stenosis. Methods Between March and June 2014, a total of 57 African American cocaine users with contrast-enhanced CT angiography-confirmed less than 50% coronary stenosis in Baltimore, Maryland, were enrolled in a 6-month follow-up study to investigate whether cocaine abstinence or reduction in cocaine use is associated with decreased endothelin-1 (ET-1) levels and coronary plaque progression at the 6-month follow-up. A voucher-based incentive approach was used to systematically reinforce cocaine abstinence, and urine benzoylecgonine test was implemented to confirm cocaine use. Results Among the 57 participants, 44 were HIV-infected. The median of duration of cocaine use was 18 (interquartile range, 7-30) years. According to generalized estimating equation analyses, both cocaine abstinence and reduction in cocaine use in the 6 months were independently associated with decreased ET-1. The incidence of coronary plaque progression was 7.4/100 person-years and 23.1/100 person-years in those who were totally abstinent from cocaine and those who continued to use cocaine, respectively. However, the difference in the incidence between these 2 groups was not significant (exact P = 0.30). Conclusions The findings of this study revealed a possible association of cocaine abstinence/reduction with lowered ET levels, which suggests that such changes in cocaine use might be beneficial for preventing endothelial damage. Further studies should be conducted to investigate whether ET-1 could be used as a marker for cocaine abstinence and reduction in cocaine use.

In patients undergoing laser lead extraction, incomplete or failed lead removal occur in over 3 % of leads. Because the current available tools have limitations in reaching the right ventricle (RV), the procedure becomes challenging when the lead breaks and its fragments remain lodged in the RV. We describe two cases in which the FlexCath® steerable sheath, normally used in cryoballoon catheter ablation for atrial fibrillation, was useful in directing a bioptome to right ventricular lead fragments and thus allowing for complete lead extraction.

ObjectivesWe sought to compare the nephrotoxicity of isosmolar contrast medium (IOCM) iodixanol with low-osmolar contrast media (LOCM) and to identify predictors of contrast-induced nephropathy (CIN).BackgroundContrast-induced nephropathy is a serious complication of diagnostic and interventional procedures.MethodsPooled individual patient data (n = 2,727) from 16 double-blind, randomized, controlled trials in which patients received either intra-arterial IOCM iodixanol (n = 1,382) or LOCM (n = 1,345) were included. Patients were stratified according to chronic kidney disease (CKD), diabetes mellitus (DM), or both. Outcome measures were the maximum increase in serum creatinine (Cr) over baseline and the incidence of postprocedural CIN.ResultsThe maximum Cr increase within 3 days after contrast medium (CM) administration was significantly smaller in the iodixanol group compared with the LOCM group (0.06 mg/dl vs. 0.10 mg/dl, p < 0.001), particularly in patients with CKD (0.07 mg/dl vs. 0.16 mg/dl, p = 0.004) and CKD + DM (0.10 mg/dl vs. 0.33 mg/dl, p = 0.003). Contrast-induced nephropathy, defined as an increase in Cr ≥0.50 mg/dl within 3 days after CM administration, occurred less frequently in the iodixanol group than in the LOCM group in all patients (1.4% vs. 3.5%, p < 0.001), in CKD patients (2.8% vs. 8.4%, p = 0.001), and in CKD + DM patients (3.5% vs. 15.5%, p = 0.003). Independent predictors of CIN included CKD, CKD + DM, and use of LOCM.ConclusionsThis meta-analysis of pooled data from 2,727 patients indicates that use of the IOCM iodixanol is associated with smaller rises in Cr and lower rates of CIN than LOCM, especially in patients with CKD or CKD + DM.

Objective: To show an overall diagnostic accuracy ⩾ 90% for detection of ⩾ 50% stenoses by coronary half millimetre 32 detector row computed tomography angiography (32 × 0.5-MDCTA) in patients with advanced coronary artery disease (CAD) and a high likelihood of raised calcium scores. Methods: ECG gated 32 × 0.5-MDCTA (32 × 0.5 mm cross sections, 0.35 × 0.35 × 0.35 mm 3 isotropic voxels, 400 ms rotation) was performed after injection of iodixanol (120 ml, 320 mg/ml) in 30 consecutive patients (25 men, mean (SD) age 59 (13) years, body mass index 26.2 (4.9) kg/m 2 ). Native arteries, including ⩾ 1.5 mm branches, and bypass grafts were screened for ⩾ 50% stenoses. Stents were excluded. Conventional coronary angiography (performed 18 (12) days before 32 × 0.5-MDCTA) was analysed by quantitative coronary angiography. Results: Median Agatston calcium score was 510 (range 3–5066). Sensitivity, specificity, and positive and negative predictive values for detection of ⩾ 50% stenoses in native arteries were 76% (29 of 38), 94% (190 of 202), 71% (29 of 41), and 96% (190 of 199), respectively. Overall diagnostic accuracy was 91% (219 of 240). Due to the following artefacts 20% (69 of 352) of the vessels were excluded: motion, noise, and low contrast enhancement isolated or in combination (45 of 69 (65%)); image distortion by implantable cardioverter-defibrillator or pacemaker leads (18 of 69 (26%)); and blooming secondary to severe calcification (6 of 69 (9%)). Conclusions: Coronary 32 × 0.5-MDCTA accurately excludes ⩾ 50% stenoses in patients with advanced CAD and high calcium scores with an overall diagnostic accuracy of 91%.

Percutaneous coronary intervention, a highly effective therapy for angina, is associated with in-hospital complications including death, myocardial infarction (MI), emergency coronary artery bypass grafting, stroke, contrast-induced nephropathy (CIN), and vascular access-site problems. Patients with risk factors including advanced age, unstable angina or acute MI, impaired ejection fraction, multivessel disease, peripheral vascular disease, and renal insufficiency (RI) are at increased risk of major adverse cardiac events (MACE). Furthermore, patients with RI, diabetes, congestive heart failure, hypertension, or pre-procedure shock are at increased risk of CIN, which may result in renal failure as well as increased morbidity and mortality from cardiovascular disease. Algorithms have been developed to predict the likelihood of peri-procedural MACE or CIN for individual patients, and at-risk patients should be managed carefully. Measures to avoid MACE include use of antithrombotic therapies such as aspirin, thienopyridines, glycoprotein Gp IIb/IIIa inhibitors, and anticoagulants. In addition, evidence shows that the use of the iso-osmolar, non-ionic, dimeric contrast medium iodixanol may reduce the in-hospital incidences of both MACE (particularly MI) and CIN when compared with the low-osmolar contrast media that it has been tested against. Other approaches to avoid CIN include discontinuation of nephrotoxic drugs, such as non-steroidal anti-inflammatory medications, use of a minimum volume of contrast, provision of intravenous hydration for 24 h beginning before the procedure, and possibly administration of N-acetylcysteine.

The granting of clinical staff privileges to physicians is a primary mechanism used by institutions to uphold the quality of care. The Joint Commission on Accreditation of Healthcare Organization (JCAHO) requires that the granting of continuing medical staff privileges be based on assessments of applicants against professional criteria specified in the medical staff bylaws. Physicians themselves are thus charged with …

Background— The use of a stent to deliver a drug may reduce in-stent restenosis. Paclitaxel interrupts the smooth muscle cell cycle by stabilizing microtubules, thereby arresting mitosis. Methods and Results— On the basis of prior animal studies, the European evaLUation of the pacliTaxel Eluting Stent (ELUTES) pilot clinical trial (n=190) investigated the safety and efficacy of V-Flex Plus coronary stents (Cook Inc) coated with escalating doses of paclitaxel (0.2, 0.7, 1.4, and 2.7 μg/mm 2 stent surface area) applied directly to the abluminal surface of the stent in de novo lesions compared with bare stent alone. The primary efficacy end point was angiographic percent diameter stenosis at 6 months. At angiographic follow-up, percent diameter stenosis was 33.9±26.7% in controls (n=34) and 14.2±16.6% in the 2.7-μg/mm 2 group (n=31; P =0.006). Late loss decreased from 0.73±0.73 to 0.11±0.50 mm ( P =0.002). Binary restenosis (≥50% at follow-up) decreased from 20.6% to 3.2% ( P =0.056), with no significant benefit from intermediate paclitaxel doses. Freedom from major adverse cardiac events in the highest (effective) dose group was 92%, 89%, and 86% at 1, 6, and 12 months, respectively ( P =NS versus control). No late stent thromboses were seen in any treated group despite clopidogrel treatment for 3 months only. Conclusions— Paclitaxel applied directly to the abluminal surface of a bare metal coronary stent, at a dose density of 2.7 μg/mm 2 , reduced angiographic indicators of in-stent restenosis without short- or medium-term side effects.

Cardiac implantable electronic devices (CIEDs), having been shown capable of improving the quality as well as duration of life, are playing an increasingly important role in the management of patients with disorders of heart rhythm and/or function. Over the last decade there has been a remarkable

OBJECTIVE. The purpose of this study was to comprehensively study estimated radiation doses for subjects included in the main analysis of the Combined Non-invasive Coronary Angiography and Myocardial Perfusion Imaging Using 320 Detector Computed Tomography (CORE320) study ( ClinicalTrials.gov identifier NCT00934037), a clinical trial comparing combined CT angiography (CTA) and perfusion CT with the reference standard catheter angiography plus myocardial perfusion SPECT. SUBJECTS AND METHODS. Prospectively acquired data on 381 CORE320 subjects were analyzed in four groups of testing related to radiation exposure. Radiation dose estimates were compared between modalities for combined CTA and perfusion CT with respect to covariates known to influence radiation exposure and for the main clinical outcomes defined by the trial. The final analysis assessed variations in radiation dose with respect to several factors inherent to the trial. RESULTS. The mean radiation dose estimate for the combined CTA and perfusion CT protocol (8.63 mSv) was significantly (p < 0.0001 for both) less than the average dose delivered from SPECT (10.48 mSv) and the average dose from diagnostic catheter angiography (11.63 mSv). There was no significant difference in estimated CTA-perfusion CT radiation dose for subjects who had false-positive or false-negative results in the CORE320 main analyses in a comparison with subjects for whom the CTA-perfusion CT findings were in accordance with the reference standard SPECT plus catheter angiographic findings. CONCLUSION. Radiation dose estimates from CORE320 support clinical implementation of a combined CT protocol for assessing coronary anatomy and myocardial perfusion.

OBJECTIVES We sought to determine whether a multidisciplinary outpatient management program decreases chronic heart failure (CHF) hospital readmissions and mortality over a six-month period. BACKGROUND Hospital admission for CHF is an important problem amenable to improved outpatient management. METHODS Two hundred patients hospitalized with CHF at increased risk of hospital readmission were randomized to a multidisciplinary program or usual care. A study cardiologist and a CHF nurse evaluated each patient and made recommendations to the patient's primary physician before randomization. The intervention team consisted of a cardiologist, a CHF nurse, a telephone nurse coordinator and the patient's primary physician. Contact with the patient was on a prespecified schedule. The CHF nurse followed an algorithm to adjust medications. Patients in the nonintervention group were followed as usual. The primary outcome was the composite of the number of CHF hospital admissions and deaths over six months, compared by using a log transformation t test by intention-to-treat analysis. RESULTS The median age of the study patients was 63.5 years, and 39.5% were women. There were 43 CHF hospital admissions and 7 deaths in the intervention group, as compared with 59 CHF hospital admissions and 13 deaths in the nonintervention group (p = 0.09). The quality-of-life score, percentage of patients on target vasodilator therapy and percentage of patients compliant with diet recommendations were significantly better in the intervention group. Cost per patient, in 1998 U.S. dollars, was similar in both groups. CONCLUSIONS This study demonstrates that a six-month, multidisciplinary approach to CHF management can improve important clinical outcomes at a similar cost in recently hospitalized high-risk patients with CHF.

Aims The aim of this study was to investigate the association of left ventricular mass (LVM) with coronary atherosclerosis and myocardial infarction (MI). Methods and results Patients ( n = 338) underwent 320 × 0.5 mm detector row coronary computed tomography (CT) angiography, invasive coronary angiography (ICA), and single-photon emission CT (SPECT) myocardial perfusion imaging. Quantitative coronary atheroma volume was obtained from the CT images for the entire coronary tree (19-segment model) with an arterial contour detection algorithm. Normalized total atheroma volume (NormTAV) was analysed to reflect quantitative total atheroma volume. LVM was measured on myocardial CT images and indexed to height to the power of 2.7 (LVMi). Patients with obstructive coronary artery disease (CAD) were defined as those with ≥50% diameter stenosis by quantitative ICA. Abnormal perfusion defect was defined as ≥1 abnormal myocardial segment by SPECT. The association of LVMi with coronary atherosclerosis and myocardial perfusion defect on SPECT at the patient level was determined with uni- and multivariable linear and logistic regression analyses. Obstructive CAD was present in 60.0% of enrolled patients. LVMi was independently associated with abnormal summed rest score [SRS; odds ratio (OR), 1.07; 95% confidence interval (CI), 1.03–1.09] and summed stress score (OR, 1.04; 95% CI, 1.01–1.07). An increase in LVMi was also independently associated with that in NormTAV (coefficient, 10.44; 95% CI, 1.50–19.39) and SRS ≥1 (OR, 1.05; 95% CI, 1.01–1.10), even after adjusting for cardiovascular risk factors in patients without previous MI. Conclusions LVM was independently associated with the presence of coronary artery atherosclerosis and MI.

Cardiovascular implantable electronic devices (CIED) are a remarkable success story. These systems are widely used to prevent symptomatic bradycardia, treat malignant tachyarrhythmia, and to restore a more physiologic contraction to a failing left ventricle. Implantation of a CIED usually involves a lifelong commitment to this therapy, which, unfortunately, is not free from complication requiring removal and/or replacement of all or part of the system. The major obstacle to removal of a CIED is the fibrous attachments that develop between a lead and co-existent leads, veins, and the heart. This process increases over time such that, by one year, removal by traction alone may be problematic and, if aggressive, result in complication. Physicians, surgeons, and engineers have refined techniques of percutaneous lead extraction and developed tools, which have facilitated the process, increased success, and lowered the incidence of complication. Extraction may be performed for a variety of indications some of which are unanimously agreed upon while others remain controversial. Proponents of a broadened application of extraction have proffered the concept of 'lead management,' which includes the removal of all leads that are not clinically relevant to the patient. The benefit of this approach would be to limit the risk of future complication, such as venous occlusion or thromboembolism, and to obviate the increase in difficulty of extraction (due to longer implant duration) that might accompany removal should that be required in the future. Intuitively appealing as this approach might be, there is little evidence supporting it, and the extraordinarily large number of patients currently implanted with recalled ICD leads is indicative of the potential impact this practice may have. This review will discuss extraction, its indications, and outcomes.

Transseptal puncture (TSP) allows left atrial access for curative procedures. Intracardiac echocardiography (ICE) provides direct visualization of the interatrial septum (IAS), but adds time and expense. We reviewed 100 cardiac multidetector computed tomography (MDCT) scans of patients undergoing AF ablation to determine if the angulation and orientation of the IAS are conserved or variable. Significant variability may suggest a potential role for direct visualization of the IAS during TSP.We reviewed 100 MDCT scans obtained prior to AF ablation. The IAS plane at the fossa ovalis was identified in axial and coronal images. We measured the angle of the septum relative to an orthogonal plane. Optimal needle orientation was defined as perpendicular to the fossa ovalis.The mean axial plane angle was -60.6 ± 10.6°; range, -29.5° to -88.7°). The mean coronal plane angle was 142.6 ± 9.1°; range, 115° to 162°). The axial angle corresponded to variation in the "clock-face" orientation of the needle during puncture, and was calculated between 4 and 6 o'clock. Coronal plane angulation corresponds to the curvature of the needle tip, which varied by 47°. We found no association between patient characteristics and IAS angle.The septal orientation in the axial plane varied widely and was not predicted by clinical variables such as atrial size or prior valve surgery. The high degree of interpatient variability observed suggests that direct visualization of the septum may be helpful in the performance of TSP.

Background —Despite limiting elastic recoil and late vascular remodeling after angioplasty, coronary stents remain vulnerable to restenosis, caused primarily by neointimal hyperplasia. Paclitaxel, a microtubule-stabilizing drug, has been shown to inhibit vascular smooth muscle cell migration and proliferation contributing to neointimal hyperplasia. We tested whether paclitaxel-coated coronary stents are effective at preventing neointimal proliferation in a porcine model of restenosis. Methods and Results —Palmaz-Schatz stents were dip-coated with paclitaxel (0, 0.2, 15, or 187 μg/stent) by immersion in ethanolic paclitaxel and evaporation of the solvent. Stents were deployed with mild oversizing in the left anterior descending coronary artery (LAD) of 41 minipigs. The treatment effect was assessed 4 weeks after stent implantation. The angiographic late loss index (mean luminal diameter) decreased with increasing paclitaxel dose ( P P P P P P Conclusions —Paclitaxel-coated coronary stents produced a significant dose-dependent inhibition of neointimal hyperplasia and luminal encroachment in the pig LAD 28 days after implantation; later effects require further study. These results demonstrate the potential therapeutic benefit of paclitaxel-coated coronary stents in the prevention and treatment of human coronary restenosis.