Ultrasonography Grading of Internal Carotid Artery Disease: Multiparametric German Society of Ultrasound in Medicine (DEGUM) versus Society of Radiologists in Ultrasound (SRU) Consensus Criteria.

PURPOSE: We sought to determine the diagnostic agreement between the revised ultrasonography approach by the German Society of Ultrasound in Medicine (DEGUM) and the established Society of Radiologists in Ultrasound (SRU) consensus criteria for the grading of carotid artery disease. MATERIALS AND METHODS: Post-hoc analysis of a prospective multicenter study, in which patients underwent ultrasonography and digital subtraction angiography (DSA) of carotid arteries for validation of the DEGUM approach. According to DEGUM and SRU ultrasonography criteria, carotid arteries were independently categorized into clinically relevant NASCET strata (normal, mild [1-49 %], moderate [50-69 %], severe [70-99 %], occlusion). On DSA, carotid artery findings according to NASCET were considered the reference standard. RESULTS: We analyzed 158 ultrasonography and DSA carotid artery pairs. There was substantial agreement between both ultrasonography approaches for severe (κw 0.76, CI95 %: 0.66-0.86), but only fair agreement for moderate (κw 0.38, CI95 %: 0.19-0.58) disease categories. Compared with DSA, both ultrasonography approaches were of equal sensitivity (79.7 % versus 79.7 %; p = 1.0) regarding the identification of severe stenosis, yet the DEGUM approach was more specific than the SRU approach (70.2 % versus 56.4 %, p = 0.0002). There was equality of accuracy parameters (p > 0.05) among both ultrasonography approaches for the other ranges of carotid artery disease. CONCLUSION: While the sensitivity was equivalent, false-positive identification of severe carotid artery stenosis appears to be more frequent when using the SRU ultrasonography approach than the revised multiparametric DEGUM approach.

Validation of Multiparametric Ultrasonography Criteria with Digital Subtraction Angiography in Carotid Artery Disease: A Prospective Multicenter Study.

PURPOSE: The German Society of Ultrasound in Medicine (DEGUM) recently revised its multiparametric criteria for duplex ultrasonography (DUS) grading of internal carotid artery (ICA) disease. We determined the diagnostic accuracy of the revised DEGUM criteria for ultrasonography grading of ICA disease in a prospective multicenter study. MATERIALS AND METHODS: We evaluated consecutive patients who underwent digital subtraction angiography of the extracranial carotid arteries at four tertiary care hospitals. Blinded investigators graded ICA disease according to DEGUM-recommended ultrasonography criteria and calculated NASCET-type percent stenosis from angiography images. Endpoints included overall classification accuracy, prediction of clinically relevant disease categories and between-test agreement in the continuous range of percent stenosis. RESULTS: A total of 121 patients (median age: 69 [IQR, 16] years; 74 % men; median time between DUS and angiography: 1 day [IQR, 2]) provided 163 DUS-angiography carotid artery pairs. The classification accuracy of the DEGUM criteria to predict stenosis within 10 % increments as compared to angiography was 34.9 % (95 % CI, 28.0 - 42.6). The sensitivity of DUS for the detection of moderate (50 - 69 %) and severe (70 - 99 %) stenosis was 35 % and 81 %, with an overall accuracy of 73 % and 74 %, respectively. The specificity was 89 % and 69 %, respectively. Considering the continuous spectrum of the disease (0 - 100 %), the Bland-Altman interval limit of agreement was 51 %. CONCLUSION: At laboratories experienced with ultrasound grading of the extracranial ICA, the revised DEGUM multiparametric ultrasonography criteria do not eliminate the need for a confirmatory test for the identification of clinically relevant grades of the disease.

Carotid artery stenting in clinical practice depending on patient age.

BACKGROUND: The age-dependent outcome of carotid artery stenting (CAS) outside of randomized controlled trials is largely unknown. Therefore, we assessed acute and long-term results of CAS in a single-center real-world registry. METHODS: All symptomatic and asymptomatic patients who consecutively underwent CAS were enrolled into the present analysis. The population was divided into three groups dependent on patients' age (<65, 65-74, and ≥75 years). RESULTS: Between 1999 and 2015, a total of 878 patients (24%, <65 years; 40%, 65-74 years; and 36%, ≥75 years) underwent CAS. The rate of the primary endpoint (30-day composite of death, stroke, and myocardial infarction [MACCE] plus long-term ipsilateral stroke) was higher in patients aged ≥75 years compared to the middle-age group (hazard ratio [HR] 2.30, confidence interval [CI] 1.22-4.36; P = 0.001). Similarly, the rate of the stroke endpoint (30-day any stroke plus long-term ipsilateral stroke) was higher in patients aged ≥75 years compared to patients aged 65-74 years (HR 2.03, CI 1.01-4.10; P = 0.04). There was no significant age-dependent difference of the primary endpoint and stroke endpoint in the subset of asymptomatic patients. Furthermore, age had no influence on the risk of stroke beyond the periprocedural period. CONCLUSIONS: Patients aged ≥75 years had poorer outcomes after CAS compared to younger patients. Importantly, age did not influence the outcome in asymptomatic patients and the risk for stroke beyond the periprocedural period.

Progressive dyspnea and signs of right heart dysfunction.

A 40-year-old woman was admitted due to dyspnea and fever. Transthoracic echocardiography revealed signs of right heart volume overload and vegetations on the tricuspid valve with insufficiency. Transesophageal echocardiography showed a sinus venosus defect (SVD) with significant left-to-right shunt. Computed tomography scanning was primarily performed to rule out pulmonary embolism; however, it showed interatrial communication. Due to the concomitant tricuspid insufficiency with additional volume overload, the diagnosis of SVD was more challenging. Usually, transthoracic echocardiography remains the initial diagnostic imaging modality; however, detection rates are very low. Therefore, further imaging is mandatory in unexplained substantial right heart dilatation.

Learning Curve Assessment for Percutaneous Left Atrial Appendage Closure With the WATCHMAN Occluder.

OBJECTIVES: We sought to evaluate the effect of increasing experience with left atrial appendage (LAA) closure on short-term outcome. BACKGROUND: Data regarding the impact of the learning curve of LAA closure-particularly regarding technical aspects of the procedure-are lacking. METHODS: The present analysis represents first data from a single-center all-comer registry. The population was divided into 3 groups according to treatment time (group 1: patients 1-30; group 2: patients 31-60; group 3: patients 61-90). RESULTS: The mean age of the population was 77 years. Median CHA2 DS2 VASC Score and HAS-BLED were 5 (IQR 3-5) and 3 (IQR 3-4), respectively. Implantation success was 90% with a slight but not statistically significant increase during the course of the registry. Procedure time (75 [62-108] vs. 50 [43-66] vs. 47 [41-61] minutes; P < 0.0001), fluoroscopy time (20 [15-30] vs. 11 [8-19] vs. 11 [9-18] minutes; P = 0.002), and contrast volume (105 [70-170] vs. 60 [50-75] vs. 50 [50-73] ml; P < 0.0001) were reduced across the 3 groups. In-hospital complications decreased significantly (20 vs. 7% vs. 0%; P = 0.021). The compression grade of the occluder was chosen higher with increasing learning curve (15 [11-25] vs. 25 [17-29] vs. 21 [14-26] %; P = 0.05). CONCLUSIONS: With increasing operator experience the performance and safety of percutaneous LAA closure improved continuously.

Long-term transesophageal echocardiography follow-up after percutaneous left atrial appendage closure.

BACKGROUND: Peri-device leaks and device thrombi are assumed to lead to ischemic events after percutaneous left atrial appendage occlusion (LAAO). While these device-related complications are well assessed until 12 months after LAAO, no data are available beyond this period. OBJECTIVE: The purpose of this study was to assess device-related complications beyond 12 months after LAAO. METHODS: All patients who underwent successful percutaneous LAAO ≥12 months ago in the 2 participating centers were screened for eligibility. After inclusion, structured transesophageal echocardiography (TEE) was performed to assess peri-device leaks, device thrombus, and other device-related complications. RESULTS: A total of 63 patients were enrolled in the present prospective, 2-center, nonrandomized, single-arm trial. The median time from implantation until long-term TEE was 3.1 years (interquartile range 2.0-5.1 years), ranging from 1.0 to 7.5 years. The number of patients without a detectable leak increased significantly at long-term TEE compared with 6-week follow-up (P = .04). Major peri-device leaks (>5 mm) were detected in 2 patients (3%). Device thrombus was found in 8 patients (13%). Patients with device thrombus at long-term follow-up had larger peri-device leaks at 6-week follow-up than did those without thrombus formation (3.0 [interquartile range 2.7-3.5] vs 1.4 [interquartile range 0.0-2.6]; P = .04). Of those who suffered an ischemic stroke during long-term follow-up (n = 5), 1 patient showed a peri-device leak >5 mm. None of the patients with detected device thrombus had a stroke. CONCLUSION: Peri-device leaks and device thrombi continue to occur during long-term follow-up after LAAO. The clinical impact of these late occluder complications requires further evaluation in larger prospective trials.

Incidence and risk factors of embolized particles in carotid artery stenting and association with clinical outcome.

BACKGROUND: One of the mechanisms for periprocedural neurologic events in carotid artery stenting (CAS) is catheter manipulation within the aorta and supraaortic arteries causing plaque embolization. Therefore, the present analysis sought to determine risk factors for embolic particle dimensions and their relationship with adverse clinical events after CAS. METHODS: Between 1999 and 2015 embolic protection devices (EPD) of a total of 944 CAS procedures were evaluated regarding the occurrence and size of captured particles. RESULTS: Particles were found in 819 of 944 (87%) EPDs. Larger particles were detected in procedures using open cell stents (150±282µm vs. 107±177µm; p=0.005) and longer stents (≥40mm) (165±315µm vs. 122±215µm; p=0.026). With increasing learning curve, particle size was continually reduced (168±282µm in the first third of the cohort vs. 127±309µm in the second third vs. 108±114µm in the last third; p=0.009). Longer stents and use of Acculink stent were found to be independent predictors for particle diameter. In patients who died or sustained a stroke during long-term follow-up (median 5.5years [IQR 2.6-7.9]) significantly larger particles were captured during CAS compared to those patients with an uneventful follow-up (160±330µm vs. 121±195µm; p=0.047). CONCLUSIONS: In the vast majority of CAS procedures particles could be retrieved from the EPDs used. Procedural characteristics such as stent type and stent length were associated with larger particles.

Stroke rates after carotid artery stenting depend on study-specific definitions.

AIMS: There is no consensus definition for minor and major stroke in trials comparing CAS vs. CEA. In this study the patients of our large single-centre CAS registry suffering a procedure-related stroke were categorised as minor or major stroke according to study-specific definitions. METHODS AND RESULTS: A board-certified neurologist examined nearly all patients (99%) pre- and post-procedurally, and once again in case of a subsequent neurological deficit. To objectify the deficits the NIHS Scale and modified Rankin Scale (mRS) were used. To compare the difference of the rates of minor and major strokes according to each definition, Fleiss' Kappa and Cohen's Kappa Test were used, as appropriate. Up to 30 days, 34 (3.6%) neurological events in 947 procedures lasting >24 hours (=stroke) occurred. According to our definition (major stroke: symptoms lasting >30 days, NIHSS ≥4 and/or mRS ≥3), 15 (1.6%) sustained a major and 19 (2%) a minor stroke. The comparison of all definitions of stroke resulted in a substantial agreement (Fleiss' Kappa=0.73). The stroke rates depending on available definitions were as follows: our centre 19 minor/15 major strokes, CREST 15/18 (1 n.a.), Yadav et al 14/20, Bamford et al 18/13 (3 n.a.), Post et al 18/13 (3 n.a.), SPACE 17/17, ICSS 22/11 (1 n.a.). CONCLUSIONS: Study-specific definitions for minor and major strokes lead to significantly different rates of stroke. Therefore, study-specific definitions should be respected comparing the results of each trial. A standard definition for minor and major stroke should be used in future trials.

Long-Term Outcomes of Carotid Artery Stenting in Clinical Practice.

BACKGROUND: There is a lack of long-term data and data outside of controlled clinical trials in carotid artery stenting. Thus, we sought to evaluate the long-term effectiveness in stroke prevention by carotid artery stenting in a large number of patients in a real-world setting. METHODS AND RESULTS: The present work represents an all-comer registry with a strict, prospectively designed, follow-up protocol, including an independent pre- and postprocedural neurological assessment. Between November 1999 and March 2015, 1000 procedures in 901 patients were consecutively performed in a single center. Mean age was 71±9 years, and symptomatic stenosis was present in 262 patients (29.1%). The population was also characterized by a high comorbidity: 289 patients (32.1%) would have been excluded according to the CREST protocol (Carotid Revascularization Endarterectomy Versus Stent Trial). The median length of follow-up was 5.5 (interquartile range, 2.6-7.9) years and complete in 93% of the patients. The rate of the primary end point (composite of stroke, death, and myocardial infarction [major adverse cardiac or cerebrovascular event] by day 30 plus ipsilateral stroke beyond 30 days) was 6.9% (9.9% in symptomatic versus 5.7% in asymptomatic patients; P=0.03). The rate was higher in CREST ineligible than in CREST eligible patients (11.4% versus 4.9%; P=0.001). CONCLUSIONS: Long-term stroke prevention by carotid artery stenting is effective in experienced centers. A high percentage of patients who would have been excluded from controlled clinical trials undergoes carotid artery stenting in daily clinical practice. However, these patients have a substantially higher risk for an acute major adverse cardiac or cerebrovascular event.

Short- and long-term outcome after carotid artery stenting with neuroprotection: single-center experience within a prospective registry.

BACKGROUND: Carotid artery stenting is an alternative method to surgical endarterectomy for treatment of carotid artery stenosis. METHODS AND RESULTS: Three hundred and seventy-one consecutive patients (71+/-9 years) undergoing 405 carotid artery interventions at a single cardiologic center were studied prospectively within a therapy registry. In general, the interventional procedure was performed using neuroprotective devices to prevent distal embolization. Stents were used routinely whenever possible. Independent neurological assessment took place prior to and after carotid stenting. The neurological event rate was assessed in the early (<30 days) and late post interventional period. In asymptomatic patients, 286 interventions were done with a 30-day stroke rate of 1.3% (ipsilateral 1.0%). In symptomatic patients, strokes occurred in a significantly (p<0.005) higher rate of 5.0% after 119 interventions (all ipsilateral). At long-term follow-up (mean 728+/-548 days) additional strokes occurred ipsilateral to the side of carotid intervention in 0.4% of asymptomatic patients (1.7% of symptomatic patients); contralateral strokes were seen at long-term follow-up in 1.1% of asymptomatic (1.7% of symptomatic) patients. Due to their comorbidities, 1.6% of patients died early, and an additional 11.1% late after carotid stenting. CONCLUSION: Carotid artery stenting with the general use of neuroprotective devices yields acceptable shortterm results with respect to neurological events. Asymptomatic patients have significantly less periprocedural strokes than symptomatic patients. Neurological events during long-term follow-up are rare, in particular ipsilateral to the side of carotid stenting. Thus, carotid artery stenting with neuroprotection is a safe method for carotid revascularization, with acceptable periprocedural events, particularly in asymptomatic patients, and a good long-term neurologic outcome.