The SYMPLICITY HTN-3 randomized, blinded, sham-controlled trial confirmed the safety of renal den... more The SYMPLICITY HTN-3 randomized, blinded, sham-controlled trial confirmed the safety of renal denervation (RDN), but did not meet its primary efficacy endpoint. Prior RDN studies have demonstrated significant and durable reductions in blood pressure. This analysis investigated factors that may help explain these disparate results. Patients with resistant hypertension were randomized 2 : 1 to RDN (n = 364) or sham (n = 171). The primary endpoint was the difference in office systolic blood pressure (SBP) change at 6 months. A multivariable analysis identified predictors of SBP change. Additional analyses examined the influence of medication changes, results in selected subgroups and procedural factors. Between randomization and the 6-month endpoint, 39% of patients underwent medication changes. Predictors of office SBP reduction at 6 months were baseline office SBP ≥180 mmHg, aldosterone antagonist use, and non-use of vasodilators; number of ablations was a predictor in the RDN group....
Journal of Vascular and Interventional Radiology, 2012
To investigate the current clinical practice in postoperative endovascular aneurysm repair (EVAR)... more To investigate the current clinical practice in postoperative endovascular aneurysm repair (EVAR) imaging surveillance. Corresponding authors of EVAR publications during the years 2006-2011 and subscribers to an endovascular journal were invited to complete a 27-question online survey related to institutional demographics, standard post-EVAR imaging surveillance, and imaging protocols in special circumstances (eg, renal insufficiency). The survey was completed by 515 of 9,631 physicians performing EVAR from 52 countries. Of respondents, 65.3% were affiliated with experienced centers where EVAR has been performed for > 10 years or with > 50 EVAR procedures performed per year. Computed tomography (CT) angiography was the modality used most often for standard surveillance with a maximum time interval between studies of 12 months in 78.8% of centers out to 5 years. Experienced centers were more likely to delay follow-up imaging to 1 year after an unremarkable initial post-EVAR imaging study (P < .001), to extend surveillance intervals > 12 months (P = .043), and to use ultrasound (P < .01) for surveillance. After the detection of a type II endoleak, CT angiography was favored for follow-up by 59.4% of the respondents. Experienced centers were more likely to favor ultrasound (P = .006) and to schedule this follow-up examination later (after 6-12 months, P < .001). Of respondents, 62.8% used a glomerular filtration rate threshold of < 30 mL/min for not performing contrast-enhanced CT scan. In patients with renal insufficiency, most respondents performed ultrasound with or without a concomitant noncontrast CT scan. CT is the most frequently used method of long-term surveillance after EVAR. Use of ultrasound for long-term surveillance, extension of follow-up time intervals, or both were most often reported in experienced centers.
Background: This study presents the short-term and midterm results of direct percutaneous sac inj... more Background: 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). Methods: 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. Results: 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. Conclusions: 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.
Objective: Anemia is a common comorbid condition in various inflammatory states and an establishe... more Objective: Anemia is a common comorbid condition in various inflammatory states and an established predictor of mortality in patients with chronic heart failure, ischemic heart disease, and end-stage renal disease. The present study of patients with abdominal aortic aneurysm (AAA) undergoing endovascular repair (EVAR) assessed the relationships between baseline hemoglobin concentration and AAA size, as well as anemia and long-term survival. Methods: Between March 1994 and November 2006, 711 patients (65 women, mean age 75.8 ؎ 7.8 years) underwent elective EVAR. Anemia was defined as a hemoglobin level <13 g/dL in men and <12 g/dL in women. Post-EVAR mean follow-up was 48.3 ؎ 32.0 months. Association of hemoglobin level with AAA size was assessed with multiple linear regression. Mortality was determined with use of the internet-based Social Security Death Index and the electronic hospital record. Kaplan-Meier survival curves of anemic and nonanemic patient groups were compared by the log-rank method. Multivariable logistic regression models were used to determine the influence of anemia on vital status after EVAR. Results: A total of 218/711 (30.7%) of AAA patients undergoing EVAR had anemia at baseline. After adjustment for various risk factors, hemoglobin level was inversely related to maximum AAA diameter (: ؊ .144, 95%-CI: ؊1.482 ؊ .322, P ؍ .002). Post-EVAR survival was 65.5% at 5 years and 44.4% at 10 years. In long-term follow-up, survival was significantly lower in patients with anemia as compared to patients without anemia (P < .0001 by log-rank). Baseline hemoglobin levels were independently related to long-term mortality in multivariable Cox regression analysis adjusted for various risk factors (adjusted HR: 0.866, 95% CI: .783 to .958, P ؍ .005). Within this model, statin use (adjusted HR: .517, 95% CI: .308 to .868, P ؍ .013) was independently related to long-term survival, whereas baseline AAA diameter (adjusted HR: 1.022, 95% CI: 1.009 to 1.036, P ؍ .001) was an independently associated with increased mortality. Conclusions: Baseline hemoglobin concentration is independently associated with AAA size and reduced long-term survival following EVAR. Thus, the presence or absence of anemia offers a potential refinement of existing risk stratification instruments.
To evaluate the use of covered stent-grafts in the endovascular treatment (ET) of popliteal arter... more To evaluate the use of covered stent-grafts in the endovascular treatment (ET) of popliteal artery aneurysms (PAAs). A retrospective analysis was conducted over a period of 52 months in 18 consecutive patients (17 men; mean age +/- SD, 70 years +/- 11) undergoing ET of PAAs with the Viabahn endograft in a single center. Patient symptoms, aneurysm characteristics, technical outcomes, complications, and follow-up were assessed. Aneurysm diameters ranged from 12 to 51 mm with a mean of 30 mm (+/-11). Thirteen aneurysms (72.2%) were partially thrombosed and 12 patients (66.6%) had symptoms of lower limb ischemia at presentation (11 chronic and one acute). The technical success rate was 94%. Intraprocedural emboli and endoleak occurred in one and two patients, respectively. Fourteen patients were available for follow-up after successful treatment, with a mean follow-up time of 15 months (range, 7-37 months). All stent-grafts were patent after 1 month, with no mortality or limb loss. The primary patency rate with complete exclusion of the aneurysm at 6 months was 86%. Pre- and postprocedural noninvasive arterial studies were available in 10 patients, demonstrating improvement of the ankle-brachial index from 0.96 +/- 0.41 to 1.17 +/- 0.18, respectively (P = .06). Endovascular stent-graft repair of PAAs is a feasible treatment option. However, further follow-up studies regarding the durability of results are required.
Objective.\p=m-\To determine the effectiveness of the Palmaz balloon expand- able stent for the c... more Objective.\p=m-\To determine the effectiveness of the Palmaz balloon expand- able stent for the creation of a transjugular intrahepatic portosystemic shunt. The device is designed to achieve portal decompression in patients with variceal hemorrhage secondary to portal hypertension. Design.\p=m-\Transjugularintrahepatic portosystemic shunting was performed in eight patients during a 9-month period. Mean follow-up was 5 months. Patients.\p=m-\Allpatients had cirrhosis with portal hypertension
Tandem atherosclerotic lesions of the carotid bifurcation and the ipsilateral proximal common car... more Tandem atherosclerotic lesions of the carotid bifurcation and the ipsilateral proximal common carotid artery (CCA) or innominate arteries (IA) can be challenging to treat. A surgical approach may treat the lesion at the carotid bifurcation, but proximal CCA or IA lesions require a major surgical exposure. An endovascular approach is challenging as well since anatomic variations, such as a type III aortic arch, can render navigation very difficult. We report our experience in the hybrid surgical and endovascular treatment of complex proximal CCA and IA lesions. Eleven patients who underwent hybrid procedures with surgical exposure (with or without endarterectomy) of the carotid artery and retrograde endovascular intervention of a proximal lesion were included in the study. The mean percentage of stenosis was 81%. Seven patients underwent a carotid endarterectomy (CEA), and 4 patients underwent only a surgical cutdown for retrograde endovascular access of the IA or left CCA. All proce...
Journal of Vascular and Interventional Radiology, 2015
To compare the closure of ≤ 8-F versus 9-F to 12-F femoral access using the 8-F Angio-Seal VIP de... more To compare the closure of ≤ 8-F versus 9-F to 12-F femoral access using the 8-F Angio-Seal VIP device (St. Jude Medical, Inc, St. Paul, Minnesota). In this investigator-initiated, retrospective analysis, a consecutive series of 137 patients (n = 92 male patients [67.2%]; overall mean age, 71.0 y ± 9.8) was evaluated. Common femoral artery access was performed in all patients, and either unfractionated heparin or bivalirudin was used for anticoagulation. Access site complications were defined as follows: type 0, no bleeding; type 1, no actionable bleeding; type 2, actionable bleeding. The 8-F Angio-Seal VIP device was used for closure of ≤ 8-F femoral access in 76 patients (55.5%) and for 9-F to 12-F femoral access in 61 patients (44.5%). Access site complications were observed after 8-F Angio-Seal deployment in 11 patients (8.0%) (≤ 8 F, n = 5 [6.6%]; 9-12 F, n = 6 [9.8%]; P = .54). Comparing ≤ 8-F with 9-F to 12-F femoral access, type 1 complications were observed in 3 and 6 patients (P = .19) and type 2 complications were observed in 2 and 0 patients (P = .50), respectively. All type 1 complications were managed by applying external compression. Type 2 complications (n = 2 pseudoaneurysms) were treated with thrombin injection in 1 patient and secondary percutaneous intervention in 1 patient. Use of the 8-F Angio-Seal for the closure of &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;gt; 8-F femoral access is safe and effective. Complication rates when using the 8-F Angio-Seal for closure of ≤ 8-F and 9-F to 12-F femoral access are comparable.
Fibromuscular dysplasia (FMD), a non-inflammatory arterial disease, may lead to renovascular hype... more Fibromuscular dysplasia (FMD), a non-inflammatory arterial disease, may lead to renovascular hypertension (HTN) and cerebrovascular disease. Little is known about medication use in FMD. Clinical features and medication use were reviewed in a national FMD registry (12 US sites). Medication usage was assessed in raw and adjusted analyses. Covariates included demographic characteristics, co-morbid conditions and vascular bed involvement. A total of 874 subjects (93.6% female) were included in the analysis. Mean age was 55.6±13.1 years, 74.5% had HTN, 25.4% had a history of transient ischemic attack or stroke, and 7.5% had a history of coronary artery disease (CAD). Renal and cerebrovascular arteries were affected in 70.4% and 74.7%, respectively. Anti-platelet agents were administered to 72.9% of patients. In multivariate analyses, factors associated with a greater likelihood of anti-platelet agent use were older age (OR=1.02 per year, p=0.005), CAD (OR=3.76, p=0.015), cerebrovascular ...
Journal of Vascular and Interventional Radiology, 2015
To evaluate reliability, accuracy, and agreement of simple visual estimation (SVE) in determining... more To evaluate reliability, accuracy, and agreement of simple visual estimation (SVE) in determining the degree of peripheral arterial stenosis compared with calibrated measurements. In two sessions, 23 interventionists with a wide range of experience and subspecialty training reviewed 42 angiographic images of lower extremity and carotid arteries (21 iliofemoral arteries and 21 carotid arteries). An independent physician measured all lesions using manual calipers. Intrarater and interrater reliability were assessed by intraclass correlation. A ± 5% error was considered the threshold for accuracy, and weighted κ statistics were computed to assess agreement with respect to the degree of stenosis (&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 50%, nonsignificant; 50%-80%, significant; &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;gt; 80%, severe). Intrarater reliability of SVE was 0.99, and interrater reliability was 0.83. Accuracy varied from 52.8% for images of severe stenosis to 26.5% and 18.1% for significant and nonsignificant stenosis, respectively (P &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; .001). Agreement between SVE and caliper with regard to degree of stenosis was good (weighted κ 0.56) overall with correct classification ranging from 92.6% for severe stenosis to 53.4% and 68.2% for significant and nonsignificant stenosis, respectively (P &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; .001). Misclassification of nonsignificant and significant stenosis was more frequent for carotid arteries than for lower extremities. Despite high reliability, SVE of peripheral arterial stenosis has limited accuracy in determining the exact degree of stenosis. Although severe stenosis is readily identified by SVE, arterial stenosis of &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 80% is frequently overestimated, especially for carotid arteries, and should be confirmed by caliper assessment.
Journal of the American College of Cardiology, Jan 7, 2015
Results of the SYMPLICITY HTN-3 (Renal Denervation in Patients With Uncontrolled Hypertension) tr... more 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. 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). 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. The 12-month follow-up was available for 319 of 361 denervation subjects and 48 of 101 non-crossover subjects; 6-...
Ehlers-Danlos syndrome (EDS) type IV is a collagen vascular disease with an autosomal dominant in... more Ehlers-Danlos syndrome (EDS) type IV is a collagen vascular disease with an autosomal dominant inheritance caused by COL3A1 mutation. Patients with EDS type IV can present with organ rupture, spontaneous arterial dissections and ruptured aneurysms. Because of their propensity to form arterial dissections, aneurysms and rupture, they can develop carotid-cavernous fistula (CCF) after minor trauma or spontaneously. In EDS, it has been reported that even conventional catheter diagnostic angiography may result in large artery dissections and vessel rupture. In addition, the treatment of CCF in EDS type IV can result in up to 59% mortality after initial treatment, of which 23% is attributed to direct complications of treatment. We present the case of a patient with EDS type IV who previously had spontaneous dissection and multiple pseudoaneurysms of both the iliac and femoral arteries and the distal abdominal aorta. Several years later the patient developed a direct type A CCF which was successfully treated with endovascular embolization using a transvenous approach with detachable coils. The literature pertaining to CCF in EDS type IV and its treatment is reviewed.
Journal of vascular and interventional radiology : JVIR, 2003
Despite careful preoperative assessment, problematic access to the abdominal aorta for translumin... more Despite careful preoperative assessment, problematic access to the abdominal aorta for transluminal endografting (TE) of abdominal aortic aneurysm (AAA) is sometimes encountered. This study identifies preoperative risk factors predictive of problematic access and determines the impact of problematic access on outcomes. Three hundred twenty-one consecutive TE procedures for AAA were divided into two groups: group A, which had access problems (n = 74), and group B, which had none (n = 247). Logistic regression analysis of risk factors showed that (i) a pulmonary risk score of 3 (P <.001; odds ratio, 11.2), (ii) a hyperlipidemia score of 3 (P =.004; odds ratio, 2.6), and (iii) a small body (short height with low weight, P =.003; odds ratio, of 4.2) were independent risk factors for problematic access. Outcomes compared included rates of perioperative mortality, aborted procedure, surgical conversion, major complication, limb complication, and endoleak. The perioperative mortality ra...
Journal of the American College of Cardiology, 2014
BACKGROUND Prior studies of catheter-based renal artery denervation have not systematically perfo... more BACKGROUND Prior studies of catheter-based renal artery denervation have not systematically performed ambulatory blood pressure monitoring (ABPM) to assess the efficacy of the procedure.
Techniques in Vascular and Interventional Radiology, 2006
The discovery of heparin and its eventual incorporation into many therapeutic and diagnostic proc... more The discovery of heparin and its eventual incorporation into many therapeutic and diagnostic procedures has made this agent ubiquitous in the fields of cardiac and vascular medicine. Heparin however does have a significant complication and side-effect profile that includes both bleeding as well as vessel thrombosis through the development of heparin-induced thrombocytopenia. The recent addition of direct thrombin inhibitors, for example, bivalirudin, to the anticoagulation armaterium has produced favorable outcomes. Most of the experience with bivalirudin has been in coronary interventions and only recently have more interventionalists been turning to this agent as the sole anticoagulant for peripheral interventions even in patients who could tolerate heparin. In this review, we describe our experience with bivalirudin in peripheral interventions emphasizing how we dose and monitor this drug. In addition, this article discusses the findings in existing clinical trials involving bivalirudin.
The SYMPLICITY HTN-3 randomized, blinded, sham-controlled trial confirmed the safety of renal den... more The SYMPLICITY HTN-3 randomized, blinded, sham-controlled trial confirmed the safety of renal denervation (RDN), but did not meet its primary efficacy endpoint. Prior RDN studies have demonstrated significant and durable reductions in blood pressure. This analysis investigated factors that may help explain these disparate results. Patients with resistant hypertension were randomized 2 : 1 to RDN (n = 364) or sham (n = 171). The primary endpoint was the difference in office systolic blood pressure (SBP) change at 6 months. A multivariable analysis identified predictors of SBP change. Additional analyses examined the influence of medication changes, results in selected subgroups and procedural factors. Between randomization and the 6-month endpoint, 39% of patients underwent medication changes. Predictors of office SBP reduction at 6 months were baseline office SBP ≥180 mmHg, aldosterone antagonist use, and non-use of vasodilators; number of ablations was a predictor in the RDN group....
We previously reported that, in a randomized trial, carotid stenting with the use of an emboli-pr... more We previously reported that, in a randomized trial, carotid stenting with the use of an emboli-protection device is not inferior to carotid endarterectomy for the treatment of carotid artery disease at 30 days and at 1 year. We now report the 3-year results.
Two cases of delayed (36-month) Ancure hook fracture are reported in patients who experienced a d... more Two cases of delayed (36-month) Ancure hook fracture are reported in patients who experienced a decrease in aneurysm size and no evidence of endoleak. Both devices used redesigned hooks and are otherwise identical to those devices currently used in clinical practice. Notably, hook fractures were not visualized on all abdominal radiographic views, nor were they noted on the final "institutional" report by the reviewing radiologist. Careful clinical follow-up with multiple-view abdominal radiographs remains essential for all patients treated with an endovascular graft, with particular attention directed to the integrity of the metal components. The broader clinical significance of this observation with respect to the Ancure endograft remains to be defined. (J Vasc Surg 2001;34:353-6.)
The SYMPLICITY HTN-3 randomized, blinded, sham-controlled trial confirmed the safety of renal den... more The SYMPLICITY HTN-3 randomized, blinded, sham-controlled trial confirmed the safety of renal denervation (RDN), but did not meet its primary efficacy endpoint. Prior RDN studies have demonstrated significant and durable reductions in blood pressure. This analysis investigated factors that may help explain these disparate results. Patients with resistant hypertension were randomized 2 : 1 to RDN (n = 364) or sham (n = 171). The primary endpoint was the difference in office systolic blood pressure (SBP) change at 6 months. A multivariable analysis identified predictors of SBP change. Additional analyses examined the influence of medication changes, results in selected subgroups and procedural factors. Between randomization and the 6-month endpoint, 39% of patients underwent medication changes. Predictors of office SBP reduction at 6 months were baseline office SBP ≥180 mmHg, aldosterone antagonist use, and non-use of vasodilators; number of ablations was a predictor in the RDN group....
Journal of Vascular and Interventional Radiology, 2012
To investigate the current clinical practice in postoperative endovascular aneurysm repair (EVAR)... more To investigate the current clinical practice in postoperative endovascular aneurysm repair (EVAR) imaging surveillance. Corresponding authors of EVAR publications during the years 2006-2011 and subscribers to an endovascular journal were invited to complete a 27-question online survey related to institutional demographics, standard post-EVAR imaging surveillance, and imaging protocols in special circumstances (eg, renal insufficiency). The survey was completed by 515 of 9,631 physicians performing EVAR from 52 countries. Of respondents, 65.3% were affiliated with experienced centers where EVAR has been performed for &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;gt; 10 years or with &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;gt; 50 EVAR procedures performed per year. Computed tomography (CT) angiography was the modality used most often for standard surveillance with a maximum time interval between studies of 12 months in 78.8% of centers out to 5 years. Experienced centers were more likely to delay follow-up imaging to 1 year after an unremarkable initial post-EVAR imaging study (P &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; .001), to extend surveillance intervals &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;gt; 12 months (P = .043), and to use ultrasound (P &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; .01) for surveillance. After the detection of a type II endoleak, CT angiography was favored for follow-up by 59.4% of the respondents. Experienced centers were more likely to favor ultrasound (P = .006) and to schedule this follow-up examination later (after 6-12 months, P &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; .001). Of respondents, 62.8% used a glomerular filtration rate threshold of &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 30 mL/min for not performing contrast-enhanced CT scan. In patients with renal insufficiency, most respondents performed ultrasound with or without a concomitant noncontrast CT scan. CT is the most frequently used method of long-term surveillance after EVAR. Use of ultrasound for long-term surveillance, extension of follow-up time intervals, or both were most often reported in experienced centers.
Background: This study presents the short-term and midterm results of direct percutaneous sac inj... more Background: 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). Methods: 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. Results: 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. Conclusions: 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.
Objective: Anemia is a common comorbid condition in various inflammatory states and an establishe... more Objective: Anemia is a common comorbid condition in various inflammatory states and an established predictor of mortality in patients with chronic heart failure, ischemic heart disease, and end-stage renal disease. The present study of patients with abdominal aortic aneurysm (AAA) undergoing endovascular repair (EVAR) assessed the relationships between baseline hemoglobin concentration and AAA size, as well as anemia and long-term survival. Methods: Between March 1994 and November 2006, 711 patients (65 women, mean age 75.8 ؎ 7.8 years) underwent elective EVAR. Anemia was defined as a hemoglobin level <13 g/dL in men and <12 g/dL in women. Post-EVAR mean follow-up was 48.3 ؎ 32.0 months. Association of hemoglobin level with AAA size was assessed with multiple linear regression. Mortality was determined with use of the internet-based Social Security Death Index and the electronic hospital record. Kaplan-Meier survival curves of anemic and nonanemic patient groups were compared by the log-rank method. Multivariable logistic regression models were used to determine the influence of anemia on vital status after EVAR. Results: A total of 218/711 (30.7%) of AAA patients undergoing EVAR had anemia at baseline. After adjustment for various risk factors, hemoglobin level was inversely related to maximum AAA diameter (: ؊ .144, 95%-CI: ؊1.482 ؊ .322, P ؍ .002). Post-EVAR survival was 65.5% at 5 years and 44.4% at 10 years. In long-term follow-up, survival was significantly lower in patients with anemia as compared to patients without anemia (P < .0001 by log-rank). Baseline hemoglobin levels were independently related to long-term mortality in multivariable Cox regression analysis adjusted for various risk factors (adjusted HR: 0.866, 95% CI: .783 to .958, P ؍ .005). Within this model, statin use (adjusted HR: .517, 95% CI: .308 to .868, P ؍ .013) was independently related to long-term survival, whereas baseline AAA diameter (adjusted HR: 1.022, 95% CI: 1.009 to 1.036, P ؍ .001) was an independently associated with increased mortality. Conclusions: Baseline hemoglobin concentration is independently associated with AAA size and reduced long-term survival following EVAR. Thus, the presence or absence of anemia offers a potential refinement of existing risk stratification instruments.
To evaluate the use of covered stent-grafts in the endovascular treatment (ET) of popliteal arter... more To evaluate the use of covered stent-grafts in the endovascular treatment (ET) of popliteal artery aneurysms (PAAs). A retrospective analysis was conducted over a period of 52 months in 18 consecutive patients (17 men; mean age +/- SD, 70 years +/- 11) undergoing ET of PAAs with the Viabahn endograft in a single center. Patient symptoms, aneurysm characteristics, technical outcomes, complications, and follow-up were assessed. Aneurysm diameters ranged from 12 to 51 mm with a mean of 30 mm (+/-11). Thirteen aneurysms (72.2%) were partially thrombosed and 12 patients (66.6%) had symptoms of lower limb ischemia at presentation (11 chronic and one acute). The technical success rate was 94%. Intraprocedural emboli and endoleak occurred in one and two patients, respectively. Fourteen patients were available for follow-up after successful treatment, with a mean follow-up time of 15 months (range, 7-37 months). All stent-grafts were patent after 1 month, with no mortality or limb loss. The primary patency rate with complete exclusion of the aneurysm at 6 months was 86%. Pre- and postprocedural noninvasive arterial studies were available in 10 patients, demonstrating improvement of the ankle-brachial index from 0.96 +/- 0.41 to 1.17 +/- 0.18, respectively (P = .06). Endovascular stent-graft repair of PAAs is a feasible treatment option. However, further follow-up studies regarding the durability of results are required.
Objective.\p=m-\To determine the effectiveness of the Palmaz balloon expand- able stent for the c... more Objective.\p=m-\To determine the effectiveness of the Palmaz balloon expand- able stent for the creation of a transjugular intrahepatic portosystemic shunt. The device is designed to achieve portal decompression in patients with variceal hemorrhage secondary to portal hypertension. Design.\p=m-\Transjugularintrahepatic portosystemic shunting was performed in eight patients during a 9-month period. Mean follow-up was 5 months. Patients.\p=m-\Allpatients had cirrhosis with portal hypertension
Tandem atherosclerotic lesions of the carotid bifurcation and the ipsilateral proximal common car... more Tandem atherosclerotic lesions of the carotid bifurcation and the ipsilateral proximal common carotid artery (CCA) or innominate arteries (IA) can be challenging to treat. A surgical approach may treat the lesion at the carotid bifurcation, but proximal CCA or IA lesions require a major surgical exposure. An endovascular approach is challenging as well since anatomic variations, such as a type III aortic arch, can render navigation very difficult. We report our experience in the hybrid surgical and endovascular treatment of complex proximal CCA and IA lesions. Eleven patients who underwent hybrid procedures with surgical exposure (with or without endarterectomy) of the carotid artery and retrograde endovascular intervention of a proximal lesion were included in the study. The mean percentage of stenosis was 81%. Seven patients underwent a carotid endarterectomy (CEA), and 4 patients underwent only a surgical cutdown for retrograde endovascular access of the IA or left CCA. All proce...
Journal of Vascular and Interventional Radiology, 2015
To compare the closure of ≤ 8-F versus 9-F to 12-F femoral access using the 8-F Angio-Seal VIP de... more To compare the closure of ≤ 8-F versus 9-F to 12-F femoral access using the 8-F Angio-Seal VIP device (St. Jude Medical, Inc, St. Paul, Minnesota). In this investigator-initiated, retrospective analysis, a consecutive series of 137 patients (n = 92 male patients [67.2%]; overall mean age, 71.0 y ± 9.8) was evaluated. Common femoral artery access was performed in all patients, and either unfractionated heparin or bivalirudin was used for anticoagulation. Access site complications were defined as follows: type 0, no bleeding; type 1, no actionable bleeding; type 2, actionable bleeding. The 8-F Angio-Seal VIP device was used for closure of ≤ 8-F femoral access in 76 patients (55.5%) and for 9-F to 12-F femoral access in 61 patients (44.5%). Access site complications were observed after 8-F Angio-Seal deployment in 11 patients (8.0%) (≤ 8 F, n = 5 [6.6%]; 9-12 F, n = 6 [9.8%]; P = .54). Comparing ≤ 8-F with 9-F to 12-F femoral access, type 1 complications were observed in 3 and 6 patients (P = .19) and type 2 complications were observed in 2 and 0 patients (P = .50), respectively. All type 1 complications were managed by applying external compression. Type 2 complications (n = 2 pseudoaneurysms) were treated with thrombin injection in 1 patient and secondary percutaneous intervention in 1 patient. Use of the 8-F Angio-Seal for the closure of &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;gt; 8-F femoral access is safe and effective. Complication rates when using the 8-F Angio-Seal for closure of ≤ 8-F and 9-F to 12-F femoral access are comparable.
Fibromuscular dysplasia (FMD), a non-inflammatory arterial disease, may lead to renovascular hype... more Fibromuscular dysplasia (FMD), a non-inflammatory arterial disease, may lead to renovascular hypertension (HTN) and cerebrovascular disease. Little is known about medication use in FMD. Clinical features and medication use were reviewed in a national FMD registry (12 US sites). Medication usage was assessed in raw and adjusted analyses. Covariates included demographic characteristics, co-morbid conditions and vascular bed involvement. A total of 874 subjects (93.6% female) were included in the analysis. Mean age was 55.6±13.1 years, 74.5% had HTN, 25.4% had a history of transient ischemic attack or stroke, and 7.5% had a history of coronary artery disease (CAD). Renal and cerebrovascular arteries were affected in 70.4% and 74.7%, respectively. Anti-platelet agents were administered to 72.9% of patients. In multivariate analyses, factors associated with a greater likelihood of anti-platelet agent use were older age (OR=1.02 per year, p=0.005), CAD (OR=3.76, p=0.015), cerebrovascular ...
Journal of Vascular and Interventional Radiology, 2015
To evaluate reliability, accuracy, and agreement of simple visual estimation (SVE) in determining... more To evaluate reliability, accuracy, and agreement of simple visual estimation (SVE) in determining the degree of peripheral arterial stenosis compared with calibrated measurements. In two sessions, 23 interventionists with a wide range of experience and subspecialty training reviewed 42 angiographic images of lower extremity and carotid arteries (21 iliofemoral arteries and 21 carotid arteries). An independent physician measured all lesions using manual calipers. Intrarater and interrater reliability were assessed by intraclass correlation. A ± 5% error was considered the threshold for accuracy, and weighted κ statistics were computed to assess agreement with respect to the degree of stenosis (&amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 50%, nonsignificant; 50%-80%, significant; &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;gt; 80%, severe). Intrarater reliability of SVE was 0.99, and interrater reliability was 0.83. Accuracy varied from 52.8% for images of severe stenosis to 26.5% and 18.1% for significant and nonsignificant stenosis, respectively (P &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; .001). Agreement between SVE and caliper with regard to degree of stenosis was good (weighted κ 0.56) overall with correct classification ranging from 92.6% for severe stenosis to 53.4% and 68.2% for significant and nonsignificant stenosis, respectively (P &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; .001). Misclassification of nonsignificant and significant stenosis was more frequent for carotid arteries than for lower extremities. Despite high reliability, SVE of peripheral arterial stenosis has limited accuracy in determining the exact degree of stenosis. Although severe stenosis is readily identified by SVE, arterial stenosis of &amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;amp;lt; 80% is frequently overestimated, especially for carotid arteries, and should be confirmed by caliper assessment.
Journal of the American College of Cardiology, Jan 7, 2015
Results of the SYMPLICITY HTN-3 (Renal Denervation in Patients With Uncontrolled Hypertension) tr... more 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. 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). 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. The 12-month follow-up was available for 319 of 361 denervation subjects and 48 of 101 non-crossover subjects; 6-...
Ehlers-Danlos syndrome (EDS) type IV is a collagen vascular disease with an autosomal dominant in... more Ehlers-Danlos syndrome (EDS) type IV is a collagen vascular disease with an autosomal dominant inheritance caused by COL3A1 mutation. Patients with EDS type IV can present with organ rupture, spontaneous arterial dissections and ruptured aneurysms. Because of their propensity to form arterial dissections, aneurysms and rupture, they can develop carotid-cavernous fistula (CCF) after minor trauma or spontaneously. In EDS, it has been reported that even conventional catheter diagnostic angiography may result in large artery dissections and vessel rupture. In addition, the treatment of CCF in EDS type IV can result in up to 59% mortality after initial treatment, of which 23% is attributed to direct complications of treatment. We present the case of a patient with EDS type IV who previously had spontaneous dissection and multiple pseudoaneurysms of both the iliac and femoral arteries and the distal abdominal aorta. Several years later the patient developed a direct type A CCF which was successfully treated with endovascular embolization using a transvenous approach with detachable coils. The literature pertaining to CCF in EDS type IV and its treatment is reviewed.
Journal of vascular and interventional radiology : JVIR, 2003
Despite careful preoperative assessment, problematic access to the abdominal aorta for translumin... more Despite careful preoperative assessment, problematic access to the abdominal aorta for transluminal endografting (TE) of abdominal aortic aneurysm (AAA) is sometimes encountered. This study identifies preoperative risk factors predictive of problematic access and determines the impact of problematic access on outcomes. Three hundred twenty-one consecutive TE procedures for AAA were divided into two groups: group A, which had access problems (n = 74), and group B, which had none (n = 247). Logistic regression analysis of risk factors showed that (i) a pulmonary risk score of 3 (P <.001; odds ratio, 11.2), (ii) a hyperlipidemia score of 3 (P =.004; odds ratio, 2.6), and (iii) a small body (short height with low weight, P =.003; odds ratio, of 4.2) were independent risk factors for problematic access. Outcomes compared included rates of perioperative mortality, aborted procedure, surgical conversion, major complication, limb complication, and endoleak. The perioperative mortality ra...
Journal of the American College of Cardiology, 2014
BACKGROUND Prior studies of catheter-based renal artery denervation have not systematically perfo... more BACKGROUND Prior studies of catheter-based renal artery denervation have not systematically performed ambulatory blood pressure monitoring (ABPM) to assess the efficacy of the procedure.
Techniques in Vascular and Interventional Radiology, 2006
The discovery of heparin and its eventual incorporation into many therapeutic and diagnostic proc... more The discovery of heparin and its eventual incorporation into many therapeutic and diagnostic procedures has made this agent ubiquitous in the fields of cardiac and vascular medicine. Heparin however does have a significant complication and side-effect profile that includes both bleeding as well as vessel thrombosis through the development of heparin-induced thrombocytopenia. The recent addition of direct thrombin inhibitors, for example, bivalirudin, to the anticoagulation armaterium has produced favorable outcomes. Most of the experience with bivalirudin has been in coronary interventions and only recently have more interventionalists been turning to this agent as the sole anticoagulant for peripheral interventions even in patients who could tolerate heparin. In this review, we describe our experience with bivalirudin in peripheral interventions emphasizing how we dose and monitor this drug. In addition, this article discusses the findings in existing clinical trials involving bivalirudin.
The SYMPLICITY HTN-3 randomized, blinded, sham-controlled trial confirmed the safety of renal den... more The SYMPLICITY HTN-3 randomized, blinded, sham-controlled trial confirmed the safety of renal denervation (RDN), but did not meet its primary efficacy endpoint. Prior RDN studies have demonstrated significant and durable reductions in blood pressure. This analysis investigated factors that may help explain these disparate results. Patients with resistant hypertension were randomized 2 : 1 to RDN (n = 364) or sham (n = 171). The primary endpoint was the difference in office systolic blood pressure (SBP) change at 6 months. A multivariable analysis identified predictors of SBP change. Additional analyses examined the influence of medication changes, results in selected subgroups and procedural factors. Between randomization and the 6-month endpoint, 39% of patients underwent medication changes. Predictors of office SBP reduction at 6 months were baseline office SBP ≥180 mmHg, aldosterone antagonist use, and non-use of vasodilators; number of ablations was a predictor in the RDN group....
We previously reported that, in a randomized trial, carotid stenting with the use of an emboli-pr... more We previously reported that, in a randomized trial, carotid stenting with the use of an emboli-protection device is not inferior to carotid endarterectomy for the treatment of carotid artery disease at 30 days and at 1 year. We now report the 3-year results.
Two cases of delayed (36-month) Ancure hook fracture are reported in patients who experienced a d... more Two cases of delayed (36-month) Ancure hook fracture are reported in patients who experienced a decrease in aneurysm size and no evidence of endoleak. Both devices used redesigned hooks and are otherwise identical to those devices currently used in clinical practice. Notably, hook fractures were not visualized on all abdominal radiographic views, nor were they noted on the final "institutional" report by the reviewing radiologist. Careful clinical follow-up with multiple-view abdominal radiographs remains essential for all patients treated with an endovascular graft, with particular attention directed to the integrity of the metal components. The broader clinical significance of this observation with respect to the Ancure endograft remains to be defined. (J Vasc Surg 2001;34:353-6.)
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