Nonvascular Causes Research Articles

Imaging Spectrum of TIPIC Syndrome : Validation of anew Entity with Vessel Wall Imaging.

Acute neck pain can have non-vascular and vascular causes. Some patients present with distinct vascular and perivascular changes on imaging at the site of tenderness. This study aimed to evaluate the imaging findings of transient perivascular inflammation of the carotid artery (TIPIC) syndrome with an emphasis on vessel wall imaging using 3‑Tesla (3-T) high-resolution (HR) magnetic resonance imaging (MRI). Clinical data along with diagnostic and follow-up imaging of patients presenting to these hospitals with acute neck pain/tenderness and at least 1 imaging study using color Doppler ultrasound (CDU) and/or MRI including vessel wall imaging from September 2013 through September 2017 were retrospectively evaluated. Atotal of 15 patients with no other underlying cause of pain, findings meeting the imaging criteria for TIPIC syndrome and clinical recovery (spontaneous or with treatment) were included in the study. The mean patient age was 43.2 years. With CDU and precontrast MRI, perivascular inflammation (PVI) of the involved artery segment was evident in all patients. Contrast enhancement of the adventitia and PVI were noted on postcontrast HR vessel wall MRI in all patients. Of the patients five had co-existing plaques at the site of tenderness. Follow-up imaging demonstrated pronounced regression or complete resolution of the findings. Imaging is useful for the establishment of TIPIC syndrome diagnosis and to rule out other conditions. The use of CDU is usually sufficient for diagnosis and follow-up but in clinically doubtful and complicated cases, vessel wall imaging with HR-MRI is very valuable. Thorough knowledge of this entity among radiologists enables a prompt diagnosis, which accelerates the clinical management.

Association of Multiple Biomarkers With Risk of All-Cause and Cause-Specific Mortality After Acute Coronary Syndromes

Mortality remains at about 5% within a year after an acute coronary syndrome event. Prior studies have assessed biomarkers in relation to all-cause or cardiovascular deaths but not across multiple causes. To assess if different biomarkers provide information about the risk for all-cause and cause-specific mortality. The Platelet Inhibition and Patient Outcomes (PLATO) trial randomized 18 624 patients with acute coronary syndrome to ticagrelor or clopidogrel from October 2006 through July 2008. In this secondary analysis biomarker substudy, 17 095 patients participated. Death due to myocardial infarction, heart failure, sudden cardiac death/arrhythmia, bleeding, procedures, other vascular causes, and nonvascular causes, as well as all-cause death. At baseline, levels of cystatin-C, growth differentiation factor-15 (GDF-15), high-sensitivity C-reactive protein, high-sensitivity troponin I and T, and N-terminal pro-B-type natriuretic peptide (NT-proBNP) were determined. The median (interquartile range) age of patients was 62.0 (54.0-71.0) years. Of 17 095 patients, 782 (4.6%) died during follow-up. The continuous associations between biomarkers and all-cause and cause-specific mortality were modeled using Cox models and presented as hazard ratio (HR) comparing the upper vs lower quartile. For all-cause mortality, NT-proBNP and GDF-15 were the strongest markers with adjusted HRs of 2.96 (95% CI, 2.33-3.76) and 2.65 (95% CI, 2.17-3.24), respectively. Concerning death due to heart failure, NT-proBNP was associated with an 8-fold and C-reactive protein, GDF-15, and cystatin-C, with a 3-fold increase in risk. Regarding sudden cardiac death/arrhythmia, NT-proBNP was associated with a 4-fold increased risk and GDF-15 with a doubling in risk. Growth differentiation factor-15 had the strongest associations with other vascular and nonvascular deaths and was possibly associated with death due to major bleeding (HR, 4.91; 95% CI, 1.39-17.43). In patients with acute coronary syndrome, baseline levels of NT-proBNP and GDF-15 were strong markers associated with all-cause death based on their associations with death due to heart failure as well as due to arrhythmia and sudden cardiac death. Growth differentiation factor-15 had the strongest associations with death due to other vascular or nonvascular causes and possibly with death due to bleeding. ClinicalTrials.gov Identifier: NCT00391872.

Performing diagnostic coronary angiography to evaluate high-risk cardiac donors: A French nationwide cohort study

BackgroundAllograft shortage might be overcome by the use of hearts from expanded-criteria donors (ECD) but their estimated high-risk of coronary artery disease (CAD) results in a limited utilization of these hearts for transplantation. We aimed to determine if performing coronary angiography (CA) in ECD enhances cardiac procurement and to develop a predictive model estimating their probability of absence of CAD. MethodsWe retrospectively used the French National Transplant Registry CRISTAL and considered all donors aged 45 to 70 with ≥ 1 organ harvested between March 2012 and June 2014 to derive a high-risk donor population. Of 515 donors with ≥ 1 CAD risk factor and no obvious contraindication for cardiac procurement, 230 underwent CA. Coefficients estimated by multivariate logistic regression models were used to evaluate the impact of CA on procurement and build the predictive model. ResultsAmong CA donors, 133 had CAD, 53 (23%) with at least one stenosis ≥ 50%. Predictors of cardiac graft offer were female gender, age below 60, no cardiac arrest, no intravenous adrenaline/dobutamine requirement and no treated hypercholesterolemia. CA increased the probability of procurement by 9% (p = 0.028). Female gender, non-vascular cause of death, absence of diabetes and BMI ≥ 25 kg/m2 (p < 0.05) were associated with a normal CA and used for the prediction model. The area under the ROC curve of the model was 0.70. Specificity for the highest quartile was 82%. ConclusionPerforming CA in ECD enhances cardiac procurement. When CA is not feasible, we defined a clinical score allowing accurate estimation of normal CA probability.

Carotid artery stenting in a single center, single operator, single type of device and 15 years of follow-up

BackgroundRevascularization with carotid stent (CAS) is considered the therapeutic alternative to endarterectomy (CEA). However, its role compared to CEA remains questioned, mainly due of the heterogeneity of long-term results. The objective of this study was to report the efficacy and durability of CAS in terms of stroke prevention in a “real world experience”.MethodThis was a single-center retrospective analysis of 344 patients treated with CAS between January 2001 and December 2015.The primary outcome of the trial was stroke, myocardial infarction, or death during a periprocedural period or any stroke event over a 15-year follow-up. The secondary aim was to identify risk factors for 30-day complications, long-term neurological complications, and intra-stent restenosis.ResultsThe primary composite end point (any stroke, myocardial infarction, or death during the periprocedural period) was 2.3%. The use of an EPD was protective against major complications.Long-term follow-up was achieved in 294 patients (85,5%) with a median of 50 months (range 0-155 months). Fifty-six (16,3%) died within this period, most commonly of nonvascular causes (4 patients had stroke-related deaths). During the follow-up period, 8 strokes and 3 TIAs were diagnosed (3.2%).ISR determined by sequential ultrasound was assessed in 4.4% of the patients and remained asymptomatic in all but 2 patients (0.6%). All patients with restenosis underwent revascularization with balloon angioplasty.ConclusionThe long-term follow-up results of our study validate CAS as a safe and durable procedure with which to prevent ipsilateral stroke, with an acceptable rate of restenosis, recurrence and mortality.

Perfusion imaging and recurrent cerebrovascular events in intracranial atherosclerotic disease or carotid occlusion.

Background Large vessel disease stroke subtype carries the highest risk of early recurrent stroke. In this study we aim to look at the association between impaired perfusion and early stroke recurrence in patients with intracranial atherosclerotic disease or total cervical carotid occlusion. Methods This is a retrospective study from a comprehensive stroke center where we included consecutive patients 18 years or older with intracranial atherosclerotic disease or total cervical carotid occlusion admitted with a diagnosis of ischemic stroke within 24 h from symptom onset with National Institute Health Stroke Scale < 15, between 1 December 2016 and 30 June 2017. Patients with (1) evidence of ≥ 50% stenosis of a large intracranial artery or total carotid artery occlusion, (2) symptoms referable to the territory of the affected artery, and (3) perfusion imaging data using the RAPID processing software were included. The primary predictor was unfavorable perfusion imaging defined as Tmax > 6 s mismatch volume (penumbra volume-infarct volume) of 15 ml or more. The outcome was recurrent cerebrovascular events at 90 days defined as worsening or new neurological symptoms in the absence of a nonvascular cause attributable to the decline, or new infarct or infarct extension in the territory of the affected artery. We used Cox proportional hazards models to determine the association between impaired perfusion and recurrent cerebrovascular events. Results Sixty-two patients met our inclusion criteria; mean age 66.4 ± 13.1 years, 64.5% male (40/62) and 50.0% (31/62) with intracranial atherosclerotic disease. When compared to patients with favorable perfusion pattern, patients with unfavorable perfusion pattern were more likely to have recurrent cerebrovascular events (55.6% (10/18) versus 9.1% (4/44), p < 0.001). This association persisted after adjusting for potential confounders (adjusted hazard ratio 10.44, 95% confidence interval 2.30-47.42, p = 0.002). Conclusion Perfusion mismatch predicts recurrent cerebrovascular events in patients with ischemic stroke due to intracranial atherosclerotic disease or total cervical carotid occlusion. Studies are needed to determine the utility of revascularization strategies in this patient population.

When to ask for a skin biopsy in a patient with leg ulcer? Retrospective study of 143 consecutive biopsies

A vascular cause is found in around 85% of leg ulcer patients, but non-vascular causes are also observed. Their diagnosis is based on a set of clinical arguments and skin biopsy with histological analysis. The aim of this study was to analyze the results of these biopsies and to find common criteria for ulcers whose skin biopsies had led to the diagnosis of a non-vascular ulcer. A retrospective study was carried out on the analysis of 143 skin biopsies of leg ulcers. The reasons for the biopsy were mainly atypical clinical signs and/or the lack of improvement in care after 6 months, as advocated by the French health authorities. The skin biopsies led to a diagnosis of non-vascular ulcer in 4.9% of cases (7/143), including skin cancer (n=5, 3.5%), cutaneous leishmaniasis (n=1, 0.7%) and Pyoderma gangrenosum (n=1, 0.7%). The univariate statistical analysis revealed that an elevated rim and abnormal excessive granulation tissue were significantly more frequently found in these ulcers. All patients with a positive skin biopsy had associated vascular involvement. This study found a 5% rate of non-vascular causes of ulcers, mainly skin cancer. Elevated rims and abnormal excessive granulation tissue were the unusual features most commonly found in these ulcers. All patients whose skin biopsy revealed a non-vascular cause had associated vascular involvement. This information confirms the need to perform a skin biopsy, even in the presence of a vascular disease.

The Component Timed-Up-and-Go test: the utility and psychometric properties of using a mobile application to determine prosthetic mobility in people with lower limb amputations

Objective: Using a custom mobile application to evaluate the reliability and validity of the Component Timed-Up-and-Go test to assess prosthetic mobility in people with lower limb amputation. Design: Cross-sectional design. Setting: National conference for people with limb loss. Subjects: A total of 118 people with non-vascular cause of lower limb amputation participated. Subjects had a mean age of 48 (±13.7) years and were an average of 10 years post amputation. Of them, 54% (n = 64) of subjects were male. Intervention: None. Main measure: The Component Timed-Up-and-Go was administered using a mobile iPad application, generating a total time to complete the test and five component times capturing each subtask (sit to stand transitions, linear gait, turning) of the standard timed-up-and-go test. The outcome underwent test–retest reliability using intraclass correlation coefficients (ICCs) and convergent validity analyses through correlation with self-report measures of balance and mobility. Results: The Component Timed-Up-and-Go exhibited excellent test–retest reliability with ICCs ranging from .98 to .86 for total and component times. Evidence of discriminative validity resulted from significant differences in mean total times between people with transtibial (10.1 (SD: ±2.3)) and transfemoral (12.76 (SD: ±5.1) amputation, as well as significant differences in all five component times (P < .05). Convergent validity of the Component Timed-Up-and-Go was demonstrated through moderate correlations with the PLUS-M (rs = −.56). Conclusion: The Component Timed-Up-and-Go is a reliable and valid clinical tool for detailed assessment of prosthetic mobility in people with non-vascular lower limb amputation. The iPad application provided a means to easily record data, contributing to clinical utility.

TIPIC Syndrome: Beyond the Myth of Carotidynia, a New Distinct Unclassified Entity.

The differential diagnosis of acute cervical pain includes nonvascular and vascular causes such as carotid dissection, carotid occlusion, or vasculitis. However, some patients present with unclassified vascular and perivascular changes on imaging previously reported as carotidynia. The aim of our study was to improve the description of this as yet unclassified clinico-radiologic entity. From January 2009 through April 2016, 47 patients from 10 centers presenting with acute neck pain or tenderness and at least 1 cervical image showing unclassified carotid abnormalities were included. We conducted a systematic, retrospective study of their medical charts and diagnostic and follow-up imaging. Two neuroradiologists independently analyzed the blinded image datasets. The median patient age was 48 years. All patients presented with acute neck pain, and 8 presented with transient neurologic symptoms. Imaging showed an eccentric pericarotidian infiltration in all patients. An intimal soft plaque was noted in 16 patients, and a mild luminal narrowing was noted in 16 patients. Interreader reproducibility was excellent. All patients had complete pain resolution within a median of 13 days. At 3-month follow-up, imaging showed complete disappearance of vascular abnormalities in 8 patients, and a marked decrease in all others. Our study improved the description of an unclassified, clinico-radiologic entity, which could be described by the proposed acronym: TransIent Perivascular Inflammation of the Carotid artery (TIPIC) syndrome.

Effect on non-vascular outcomes of lowering LDL cholesterol in patients with chronic kidney disease: results from the Study of Heart and Renal Protection

BackgroundReducing LDL cholesterol (LDL-C) with statin-based therapy reduces the risk of major atherosclerotic events among patients with chronic kidney disease (CKD), with no evidence of an excess risk of cancer or death from any non-vascular cause. However, non-randomized data have suggested that statin therapy may have effects (both adverse and beneficial) on particular non-vascular conditions that do not cause death.MethodsThe Study of Heart and Renal Protection (SHARP) randomized patients with CKD to simvastatin 20 mg plus ezetimibe 10 mg (simvastatin/ezetimibe) daily versus matching placebo. Participants were followed up at least 6 monthly and all post-randomization serious adverse events (SAEs) were recorded. This supplementary analysis reports the effects of treatment on non-vascular SAEs, overall, by system of disease, by baseline characteristics, and by duration of follow-up.ResultsDuring a median of 4.9 years follow-up, similar numbers of participants in the two groups experienced at least one non-vascular SAE (3551 [76.4%] simvastatin/ezetimibe vs 3537 [76.6%] placebo; risk ratio [RR] 0.99, 95% confidence interval [CI] 0.95–1.04). There was no good evidence of any significant effect of simvastatin/ezetimibe on SAEs attributed to any particular nonvascular disease system (of 43 comparisons, only 3 yielded an uncorrected p value < 0.05, of which the smallest was p = 0.02). The relative risk of any nonvascular SAE did not vary significantly among particular prognostic subgroups or by duration of follow-up.ConclusionsIn the SHARP trial, allocation to simvastatin/ezetimibe combination therapy was not associated with any significant non-vascular hazard.Trials registrationSHARP was retrospectively registered after the first participant was enrolled in 2003 at ISRCTN (ISRCTN54137607 on 31 January 2005: http://www.isrctn.com/ISRCTN54137607) and ClinicalTrials.gov (NCT00125593 on 29 July 2005: https://clinicaltrials.gov/ct2/show/NCT00125593).

Isolated intraventricular haemorrhage in adults.

While intraventricular haemorrhage is frequently found in association with intraparenchymal or subarachnoid haemorrhage, isolated intraventricular haemorrhage (iIVH) is rare in adults and seldom described. Awareness of possible causes is important in order to guide patient management. After elimination of a traumatic cause, numerous aetiologies remain possible. The most frequently found underlying lesions are arteriovenous malformations and aneurysms, but other vascular causes should also be sought, including cavernous malformations and moyamoya disease. Arterial hypertension, anticoagulant use, coagulopathies and certain toxic substances are also associated with iIVH. Finally, iIVH may be caused by intraventricular tumours. In a high number of cases, the cause remains unknown. Vascular and non-vascular causes should be searched through an imaging work-up (with CT angiography, MRI and catheter angiography when necessary) and correlation with clinical information to yield a diagnosis. The aim of this pictorial essay was to review the aetiologies of iIVH in adults.

The role of very high high-sensitivity C-reactive protein levels on mortality after stroke

High-sensitivity C-reaction protein (hsCRP) levels are correlated with risk of vascular disease. The clinical implications of markedly elevated hsCRP levels in the setting of acute stroke are less understood. ObjectiveTo determine the association of very high admission hsCRP levels (≥10mg/L) on all-cause mortality in patients with acute stroke. MethodsA retrospective cohort study of 1176 patients hospitalized with acute stroke between 2005 and 2012 who had a hsCRP assay drawn within seven days of admission. Mortality data was obtained using Ohio Death Index. Cox proportional analysis was used to determine hazard ratios of death among patients with hsCRP values >10mg/L after adjusting for age, sex, race and relevant co-morbid conditions. NIHSS was also adjusted in a subset of patients in whom it was available (n=378). ResultsPatients with hsCRP >10mg/L had 2.65 (95% CI: 1.99, 3.53) increased hazard of all-cause mortality compared to stroke patients with hsCRP ≤10mg/L. Association of hsCRP with mortality was greater for patients with low NIHSS and declined in patients with increasing NIHSS scores. A higher proportion of patients with hsCRP >10 died from nonvascular causes than patients with hsCRP ≤10mg/L. ConclusionVery high levels of hsCRP may be a useful marker to identify stroke patients at increased risk for death, especially those with stroke of mild severity. More research is needed to determine how this information can be used to improve patient care, especially in patients with mild stroke.

Abstract TP162: Case Manager Guided Organized Post-stroke Care Aids in Achieving Risk Factor Goals

Introduction: Our ongoing post-stroke care program aims at risk factors control, life-style changes and adherence to secondary prevention medication to reduce stroke recurrence and persistent disability. Methods: Consecutive acute ischemic and hemorrhagic stroke patients were prospectively included in a 1-year post stroke care program that is accomplished through a certified stroke case manager. Scheduled and non-scheduled personal contacts were regularly provided to check on risk factor control and whenever felt necessary. Target values for vascular risk factors followed current recommendations of the European stroke guidelines. Results: Between 12/2011 and 07/2014 we enrolled 101 of 155 screened patients: 58/101 (57%) were male, mean age was 71+/-13 years, median baseline NIHSS score was 2 (range 0-16), 80/101 (79%) had an ischemic stroke, 3/101 (3%) hemorrhagic stroke and 18/101 (18%) patients had a TIA. Twelve out of 101 patients withdrew from the program and three patients died due to non-vascular causes. In total 628 personal (6.2/patient) and 2683 phone contacts (26.6/patient) were conducted by the case manager. Three hundred-seventy nine specific interventions were necessary mostly due to missing medication, non-compliance and social needs. No recurrent stroke occurred during the program. Achieved vascular risk factor values are presented in the Table. Conclusion: Our findings underline that organized post-stroke care may aid in achieving pre-defined goals for secondary prevention of stroke. Further data is needed to explore its impact on stroke recurrence, prevention of persistent disability and health-care costs.

Protocol for analyses of adverse event data from randomized controlled trials of statin therapy

The Cholesterol Treatment Trialists' (CTT) Collaboration was originally established to conduct individual participant data meta-analyses of major vascular events, cause-specific mortality, and site-specific cancers in large, long-term, randomized trials of statin therapy (and other cholesterol-modifying treatments). The results of the trials of statin therapy and their associated meta-analyses have shown that statins significantly reduce the risk of major vascular events without any increase in the risk of nonvascular causes of death or of site-specific cancer, but do produce small increases in the incidence of myopathy, diabetes, and, probably, hemorrhagic stroke. The CTT Collaboration has not previously sought data on other outcomes, and so a comprehensive meta-analysis of all adverse events recorded in each of the eligible trials has not been conducted. This protocol prospectively describes plans to extend the CTT meta-analysis data set so as to provide a more complete understanding of the nature and magnitude of any other effects of statin therapy.

Can vascular mortality be reliably ascertained from the underlying cause of death recorded on a medical death certificate? Evidence from 2800 adjudicated heart protection study (HPS) deaths

Results Of 20536 participants, 2835 died during trial follow-up, of whom 2778 (98%) were recorded by UK mortality registers. Among these registered deaths, 1260 were adjudicated to coronary heart disease(CHD). Certified UCD agreed with 1152 of these, attributed 108 adjudicated CHD deaths to other causes (including 71 non-vascular causes) and wrongly ascribed 81 non-CHD deaths to CHD (ĸ=0.86, 95% confidence interval 0.84-0.88). Of the 214 adjudicated stroke deaths, certified UCD agreed with 161 but attributed 53 to other causes and ascribed 26 non-stroke deaths to stroke (ĸ=0.78, 0.740.83). Of the 60 ischaemic stroke deaths, certified UCD recorded 7 as ischaemic stroke, 29 as unknown stroke and 24 to other causes, resulting in poor agreement (ĸ=0.19, 0.07-0.31). Overall, however, agreement for any vascular death remained good (ĸ=0.84, 0.82-0.86). In HPS allocation to active treatment reduced vascular deaths by 17% (781/10269(7.6%) versus 937/10267 (9.1%); risk ratio 0.83, 0.75-0.91). Had follow-up solely relied on certified UCD this result would have been materially unchanged (737(7.2%) versus 900(8.8%); risk ratio 0.81, 0.74-0.90).

Clinical and diagnostic findings in patients with elevated cerebrospinal bilirubin

IntroductionCerebrospinal fluid (CSF) spectroscopy can identify subarachnoid haemorrhage (SAH) when CT is negative in patients presenting with acute severe headache. The primary objective of this study was to evaluate the...

Approach to the Swollen Arm With Chronic Dialysis Access: It's Not Just Deep Vein Thrombosis.

The purposes of this pictorial essay are as follows: (1) Review a systematic approach to using sonography in the initial evaluation of patients with acute arm swelling and permanent dialysis access. (2) Identify normal grayscale and Doppler findings in arteriovenous fistulas and grafts. (3) Discuss a spectrum of vascular differential diagnoses for arm swelling in this setting, including stenosis of the access, draining vein complications, thrombosis, steal syndrome, and aneurysms, as well as several nonvascular causes. (4) Recognize findings that warrant further imaging evaluation or intervention.

Validation of Diagnoses of Transient Ischemic Attack in the Swedish Stroke Register (Riksstroke) TIA-Module

Background: In 2010, the Swedish Stroke Register (Riksstroke; RS) established a module for transient ischemic attacks (RS-TIA). We report a diagnostic validation study of patients included in RS-TIA. Methods: During the first year, 7,825 patients were registered at 59 out of 74 Swedish hospitals. A time-based TIA definition was applied. A sample of 180 patients (30 patients each from 6 hospitals), with a similar distribution of age and sex as in RS-TIA, was prepared. Two independent observers assessed medical records for quality of documentation and assigned a diagnosis of likely, possible, unlikely TIA or ischemic stroke, according to prespecified criteria. Results: The 2 observers agreed in 77% of cases that the event was a likely or possible TIA, in 3% that the event was an ischemic stroke, and in 2% that the event was an unlikely TIA. The observers disagreed in 8% of patients on TIA vs. ischemic stroke, and in 11% on a vascular vs. non-vascular cause. Quality of documentation was fair. Conclusions: There was interobserver agreement on diagnosis of TIA in the majority of patients included in RS-TIA. Diagnostic accuracy may be further improved by more systematic documentation of symptoms and signs.

Etiology of Corpus Callosum Lesions with Restricted Diffusion.

Infarction of the corpus callosum is rare, and other conditions can cause magnetic resonance imaging (MRI) restricted diffusion in the callosum, leading to diagnostic uncertainty. We sought to characterize the etiology of lesions with diffusion restriction in the corpus callosum. Callosal lesions with restricted diffusion were identified at our institution between January 2000 and December 2010. Radiographic and clinical data were reviewed to determine whether the lesion was vascular and if so, to identify the underlying mechanism. A total of 174 cases were reviewed in depth; 47 % were vascular and 53 % were nonvascular. Among vascular cases, atypical mechanisms of stroke (e.g., vasculitis/vasculopathy, hypercoagulable state) were most common (37 %), followed by cardioembolism (28 %). Vascular splenial lesions in particular were likely due to atypical causes of stroke. The most common nonvascular etiologies were trauma (44 %), tumor (22 %), and demyelination (15 %). Vascular lesions were more common in older, non-Caucasian patients with vascular risk factors. Nonvascular lesions were more likely to be found in association with T2-hyperintense cortical lesions, focal intraparenchymal enhancement, or edema/mass effect on MRI. More than half of lesions with diffusion restriction in the corpus callosum are due to a nonvascular cause. Clinical and radiographic characteristics can help distinguish vascular from nonvascular lesions in the corpus callosum. Nonvascular lesions are more likely to be seen in younger patients without vascular risk factors and are more often accompanied by enhancement and edema. Vascular lesions are most commonly due to atypical stroke etiologies, and these patients may require additional diagnostic testing.

PD40-01 3 YEAR OUTCOMES OF THE ZEN TRIAL: THE MEDTRONIC ZOTAROLIMUS-ELUTING PERIPHERAL STENT SYSTEM FOR THE TREATMENT OF ED IN MALES WITH SUB-OPTIMAL RESPONSE TO PDE5 INHIBITORS

You have accessJournal of UrologySexual Function/Dysfunction/Andrology: Surgical Therapy II1 Apr 2015PD40-01 3 YEAR OUTCOMES OF THE ZEN TRIAL: THE MEDTRONIC ZOTAROLIMUS-ELUTING PERIPHERAL STENT SYSTEM FOR THE TREATMENT OF ED IN MALES WITH SUB-OPTIMAL RESPONSE TO PDE5 INHIBITORS Tobias Kohler and Irwin Goldstein Tobias KohlerTobias Kohler More articles by this author and Irwin GoldsteinIrwin Goldstein More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2015.02.2435AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES We report 3 year safety, feasibility and outcomes of zotarolimus−eluting stent implantation in focal atherosclerotic lesions of the internal pudendal arteries (IPAs) among men with erectile dysfunction (ED) and a suboptimal response to phosphodiesterase−5 inhibitors. METHODS We performed a prospective, multicenter, single-armed safety and feasibility trial of 30 male subjects > 18 years with atherosclerotic ED and a suboptimal response to phosphodiesterase-5 inhibitors. A novel combination of clinical, duplex ultrasound, and invasive angiographic factors were used to determine eligibility for stent therapy. Key inclusion criteria included IIEF-6 < 21 with at least 4 weeks of PDE5i use, ultrasound PSVs < 30 cm/sec bilaterally, and angiographic stenosis of one or both IPAs. Key exclusion criteria included non-vascular causes of ED, venous leak as seen on penile Doppler (EDV > 5 cm/sec), and non target lesions of > 70% stenosis in common iliac or common penile artery. The primary safety end point was any major adverse event 30 days after the procedure. The primary feasibility end point was improvement in the IIEF-6 (Erectile Dysfunction Domain) score of 4 points or more. RESULTS A total of 383 subjects were screened of which there was a 92% screen failure rate. Forty-five lesions were treated with stents in 30 subjects. Procedural success was 100% with no major adverse events through follow-up. The primary feasibility end point (IIEF-6 +4) was achieved by 81% of intention-to treat subjects (17/21) at 1 year, 58% (11/19) at 2 years and 39% (5/13) at three years. 5 patients were stented outside the pudendal artery. Per protocol outcomes revealed IIEF improvement by 4 points in 84% (16/19)at 1 year, 61% (11/18) at 2 years and 36% (4/11) at 3 years. Changes in IIEF6 scores from baseline for the per protocol group were + 18.6 (95% CI = 11.8-25.5) at one year, + 14.7 (6.3-23.2) at 2 years, and + 7.8 at 3 years (-0.3 - 16). Mean peak systolic velocity on penile Doppler increased from 16.4 cm/s at baseline to 32.4 cm/sec at 1 year. Angiographic binary restonosis (>50% lumen diameter stenosis) was found in 11/32 lesions (34.4%). CONCLUSIONS Among patients with ED and limited response with pharmacologic therapy, percutaneous stent revascularization of the internal pudendal artery is safe and appears promising. However, significant challenges remain in determining and screening for the appropriate patient treatment population, optimizing procedural techniques for placement, and preventing stent restenosis. © 2015 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 193Issue 4SApril 2015Page: e835 Advertisement Copyright & Permissions© 2015 by American Urological Association Education and Research, Inc.MetricsAuthor Information Tobias Kohler More articles by this author Irwin Goldstein More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

Intranuclear Expression of Progesterone Receptors in Smooth Muscle Cells of Renovascular Fibromuscular Dysplasia: A Pilot Study

The pathogenesis of fibromuscular dysplasia (FMD) remains poorly understood. Yet, understanding this mechanism has taken on new urgency after recent evidence indicating that FMD is not as rare as previously thought. We speculated that hormonal receptors in the walls of dysplastic renal arteries were implicated in the pathogenesis of FMD. We undertook a pilot prospective case-control study comparing histologic findings from renal arteries that were surgically removed in 2 patient groups. The case group included 6 samples from FMD patients who underwent surgery for stenosis or aneurysm caused by FMD. The control group included 3 FMD-free patients who underwent nephrectomy for nonvascular causes. Surgical specimens were sent to the histology laboratory. FMD was defined preoperatively using conventional radiologic criteria and was confirmed by histologic examination. Immunohistochemical staining detected intense progesterone receptor expression in the nuclei of smooth muscle cells in FMD patients. No progesterone receptor expression was found in the FMD-free patients. Estrogen receptor expression was not noted in the 2 groups. This preliminary finding may suggest that progesterone plays a key role in the pathogenesis of FMD and opens the fields of genetic and therapeutic approaches.