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Jaff M.R.,Massachusetts General Hospital | Katzen B.T.,Baptist Cardiac and Vascular Institute
Journal of Vascular and Interventional Radiology | Year: 2010

PURPOSE: To evaluate the 2-year outcomes of safety and effectiveness for iliac artery stent placement and examine the effects of placement in the common iliac artery (CIA) and external iliac artery (EIA), the degree of initial stenosis, and patient gender on success. MATERIALS AND METHODS: Zilver vascular stents (Cook Inc., Bloomington, Indiana) were placed in 151 consecutive patients whose iliac arteries remained stenotic after percutaneous transluminal angioplasty (PTA). Success at 2 years was determined by patency, ankle-brachial index (ABI) scores, and Walking Impairment Questionnaire (WIQ) scores. RESULTS: Patency, ABI measurements, and WIQ scores showed improvement at 2 years, compared with preprocedure measurements. Kaplan-Meier estimate of overall patency at 2 years was 90% (n = 117). Significant improvement in ABI and WIQ scores was seen at 2 years, compared with preprocedural values (P < .01). The 2-year overall success rate was 91%. The degree of initial stenosis, stent location, and patient gender did not affect the success of the Zilver stent (P = .65, P = .58, and P = .77). The Kaplan-Meier estimate of the probability of experiencing a major adverse event (MAE) related to the device or stent placement procedure by the 2-year follow-up was 2.7%. CONCLUSIONS: The Zilver vascular stent remains durable at 2 years in regard to safety and clinical effectiveness, and is effective in the CIA and EIA both in male and female patients. © 2010 SIR. Source

Techasith T.,Harvard University | Techasith T.,Massachusetts General Hospital | Cury R.C.,Baptist Cardiac and Vascular Institute
JACC: Cardiovascular Imaging | Year: 2011

Coronary computed tomography angiography (CTA) has been shown by several multicenter trials to have excellent diagnostic accuracy in the detection and exclusion of significant coronary stenosis. However, a major limitation of coronary CTA is that the physiological significance of stenotic lesions identified is often unknown. Stress myocardial computed tomography perfusion (CTP) is a novel examination that provides both anatomic and physiological information (i.e., myocardial perfusion). Multiple single-center studies have established the feasibility of stress myocardial CTP. Furthermore, it has been illustrated that a combined CTA/CTP protocol improves the diagnostic accuracy to detect hemodynamic significant stenosis as compared with CTA alone; this combined protocol can also be accomplished at a radiation dose comparable to nuclear myocardial perfusion imaging exams. Although initial results hold some promise, stress myocardial CTP is a modality in its infancy. Further research is required to define, validate, and optimize this new technique. However, it is a modality with significant potential, particularly in the evaluation of chest pain patients, given the advantages of short exam time and comprehensive data acquisition. This review highlights how to perform and interpret stress myocardial CTP, summarizes the current literature, and discusses some future directions. © 2011 American College of Cardiology Foundation. Source

Bhatt D.L.,Harvard University | Kandzari D.E.,Piedmont Heart Institute | O'Neill W.W.,Ford Motor Company | D'Agostino R.,Boston University | And 13 more authors.
New England Journal of Medicine | Year: 2014

BACKGROUND: Prior unblinded studies have suggested that catheter-based renal-artery denervation reduces blood pressure in patients with resistant hypertension. METHODS: We designed a prospective, single-blind, randomized, sham-controlled trial. Patients with severe resistant hypertension were randomly assigned in a 2:1 ratio to undergo renal denervation or a sham procedure. Before randomization, patients were receiving a stable antihypertensive regimen involving maximally tolerated doses of at least three drugs, including a diuretic. The primary efficacy end point was the change in office systolic blood pressure at 6 months; a secondary efficacy end point was the change in mean 24-hour ambulatory systolic blood pressure. The primary safety end point was a composite of death, end-stage renal disease, embolic events resulting in end-organ damage, renovascular complications, or hypertensive crisis at 1 month or new renal-artery stenosis of more than 70% at 6 months. RESULTS: A total of 535 patients underwent randomization. The mean (±SD) change in systolic blood pressure at 6 months was -14.13±23.93 mm Hg in the denervation group as compared with -11.74±25.94 mm Hg in the sham-procedure group (P<0.001 for both comparisons of the change from baseline), for a difference of -2.39 mm Hg (95% confidence interval [CI], -6.89 to 2.12; P = 0.26 for superiority with a margin of 5 mm Hg). The change in 24-hour ambulatory systolic blood pressure was -6.75±15.11 mm Hg in the denervation group and -4.79±17.25 mm Hg in the sham-procedure group, for a difference of -1.96 mm Hg (95% CI, -4.97 to 1.06; P = 0.98 for superiority with a margin of 2 mm Hg). There were no significant differences in safety between the two groups. CONCLUSIONS: This blinded trial did not show a significant reduction of systolic blood pressure in patients with resistant hypertension 6 months after renal-artery denervation as compared with a sham control. Copyright © 2014 Massachusetts Medical Society. Source

Bakris G.L.,University of Chicago | Townsend R.R.,University of Pennsylvania | Flack J.M.,Wayne State University | Brar S.,Medtronic | And 12 more authors.
Journal of the American College of Cardiology | Year: 2015

BACKGROUND Results of the SYMPLICITY HTN-3 (Renal Denervation in Patients With Uncontrolled Hypertension) trial confirmed the safety but not the efficacy of renal denervation for treatment-resistant hypertension at 6 months post procedure. OBJECTIVES This study sought to analyze the 12-month SYMPLICITY HTN-3 results for the original denervation group, the sham subjects who underwent denervation after the 6-month endpoint (crossover group), and the sham subjects who did not undergo denervation after 6 months (non-crossover group). METHODS Eligible subjects were randomized 2:1 to denervation or sham procedure. Subjects were unblinded to their treatment group after the 6-month primary endpoint was ascertained; subjects in the sham group meeting eligibility requirements could undergo denervation. Change in blood pressure (BP) at 12 months post randomization (6 months for crossover subjects) was analyzed. RESULTS The 12-month follow-up was available for 319 of 361 denervation subjects and 48 of 101 non-crossover subjects; 6-month denervation follow-up was available for 93 of 101 crossover subjects. In denervation subjects, the 12-month office systolic BP (SBP) change was greater than that observed at 6 months (-15.5 ± 24.1 mm Hg vs. -18.9 ± 25.4 mm Hg, respectively; p = 0.025), but the 24-h SBP change was not significantly different at 12 months (p = 0.229). The non-crossover group office SBP decreased by -32.9 ± 28.1 mm Hg at 6 months, but this response regressed to -21.4 ± 19.9 mm Hg (p = 0.01) at 12 months, increasing to 11.5 ± 29.8 mm Hg. CONCLUSIONS These data support no further reduction in office or ambulatory BP after 1-year follow-up. Loss of BP reduction in the non-crossover group may reflect decreased medication adherence or other related factors. (Renal Denervation in Patients With Uncontrolled Hypertension [SYMPLICITY HTN-3]; NCT01418261). © 2015 by the American College of Cardiology Foundation. Source

Uthoff H.,Baptist Cardiac and Vascular Institute
Journal of vascular surgery | Year: 2012

This study presents the short-term and midterm results of direct percutaneous sac injection (DPSI) for postoperative endoleak treatment after endovascular aortic aneurysm repair (EVAR). Between March 1994 and November 2011, EVAR was performed in 986 patients. The median follow-up was 63 ± 45 months (range, 0-211 months). A retrospective analysis was performed. DPSI was used in 21 patients for 19 type II endoleaks and two endoleaks of undefined origin (EOUO), of which 12 (57%) were after failure of a previous endovascular treatment attempt. DPSI using thrombin (n = 16), coils (n = 7), gelfoam (n = 6), or glue (n = 3), or a combination, was technically feasible in all patients. Saccography during DPSI revealed a previously undetected type I endoleak in three patients. Immediate DPSI success was achieved in 16 of 18 procedures (88.9%), with two complications. Glue incidentally intravasated in the inferior vena cava, causing a clinically nonsignificant subsegmental pulmonary artery embolism in one patient, and the temporary development of a type III endoleak, possibly from graft puncture, in another. During a median follow-up of 39 months (interquartile range, 13-88 months) after DPSI, recurrent endoleaks were observed in nine patients (50.0%), one type I endoleak due to graft migration, five type II endoleaks, and three EOUO. The occurrence of a re-endoleak during follow-up was significantly associated with dual-antiplatelet medication (0% in patients without re-endoleak vs 44.4% in patients with re-endoleak; P = .023) and with a nonsignificant trend for the use of aspirin alone (33.3% in patients without re-endoleak vs 80% in patients with re-endoleak; P = .094). Re-endoleak occurred in 33.3% of the patients without antiplatelet medication and in 100% of patients with dual-antiplatelet medication (P = .026). Thrombin was used as the sole embolic agent during the initial DPSI in all patients with dual-antiplatelet therapy. No other factor was significantly associated with re-endoleaks. Reintervention was deemed necessary in six patients within a median of 10 months (interquartile range, 4-16 months) after DPSI, including six additional DPSI treatments in four patients with type II re-endoleaks, cuff placements in one type I endoleak, and endograft relining in one EOUO. This initial experience suggests that DPSI is feasible as a technique for endoleak treatment after EVAR. However, complications and endoleak recurrence remain a concern. The role of antiplatelet therapy and different embolic agents on long-term embolization success needs to be studied in more detail. Copyright © 2012 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved. Source

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