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.

Tricuspid transcatheter edge-to-edge repair in a 72-year-old patient with a left ventricular assist device and prior mitral edge-to-edge repair: a case report.

Background: We report a case of a 72-year-old patient developing a significant tricuspid regurgitation (TR) 6 years after a left ventricular assist device (LVAD) implantation. The aim of this case is to demonstrate the feasibility of transcatheter edge-to-edge repair (TEER) of the tricuspid valve and the excellent clinical benefit in long-term follow-up in an LVAD patient. Case summary: Our patient presented with recurrent acute heart failure syndrome. After a fulminant myocarditis in 2005, his previous treatment consisted of cardiac resynchronization therapy, TEER of the mitral valve, and LVAD (HeartMate III) implantation. At that point in time, his TR was only mild to moderate. Due to recurrent hospitalization despite optimized heart failure medication, we decided to treat the patient with a tricuspid TEER. His immediate post-interventional result and 1-year follow-up showed an excellent outcome with only minimal TR on transoesophageal echocardiogram. Discussion: In general, TR improves after LVAD implantation. However, there are two possible pathophysiological mechanisms, which result in an increasing TR: firstly, supporting LV dysfunction may lead to a leftward shift of the interventricular septum with restriction of the tricuspid leaflets. Secondly, the increase of venous preload with LVAD support may result in an annular dilatation with secondary TR, particularly in patients with pre-existing right ventricular dysfunction. According to the data currently available, the unpredictable course of developing TR necessitates regular clinical examination and echocardiographic investigation. Treatment with TEER appears to be feasible and safe, with excellent 1-year results in patients with previously implanted LVADs.

Impact of aortic valve calcification on the outcome of transcatheter aortic valve implantation: results from the prospective multicenter German TAVI registry.

OBJECTIVES: Transcatheter aortic valve implantation (TAVI) is an emerging technology in patients with severe aortic stenosis. BACKGROUND: Whether the degree of aortic valve calcification impacts the outcome after TAVI has not been thoroughly evaluated. METHODS: We analyzed data from the prospective multicenter German TAVI registry, including 1,365 patients as of July 2010. Patients were divided into three groups, based on the degree of aortic valve calcification: mild (n = 67), moderate (n = 392), and severe (n = 906) valve calcification, determined by visual estimation by the operator. RESULTS: Mean age was 81.7 ± 6.2 years; mean logistic EUROscore was 20.6 ± 13.7%. Patients with severe aortic valve calcification had a higher mean and peak-to-peak gradient before the intervention (P < 0.0001). Technical success was achieved in 97%, similar in each group. The Medtronic CoreValve was implanted in 80.8%, the Sapien Edwards prosthesis in the remaining cases. The duration of the procedure and fluoroscopy was higher in the group with severe calcification (P < 0.01 for procedure and P < 0.05 for fluoroscopy). During the periprocedural period there were no differences among the groups regarding in-hospital death, cerebrovascular events, myocardial infarction, thromboembolic events, aortic dissection, or severe vascular complications. Furthermore, there was no significant difference in postprocedural aortic mean gradient (7.0 mm Hg vs. 5.6 mm Hg vs. 6.3 mm Hg; P = 0.07), in residual aortic regurgitation (74% vs. 72% vs. 68%; P = 0.3) or postprocedure pacemaker implantation (38% vs. 30.4% vs. 34.2%; P = 0.35). During 30-day follow up there was no difference in regard to the number of death, strokes, and myocardial infarctions. CONCLUSIONS: Our results of a real-world registry suggest that the extent of aortic valve calcification does not influence the success or procedural outcome significantly.

Anticoagulation versus antiplatelet therapy after percutaneous left atrial appendage closure-subanalysis from the multicenter LAARGE registry.

PURPOSE: Data regarding post-procedural antithrombotic therapy following percutaneous left atrial appendage (LAA) in real-world populations using various occluder systems is limited. In the present analysis, anticoagulation (AC) was compared against antiplatelet therapy (APT) using data from the real-world multi-center LAARGE study. METHODS: Patients following LAA closure enrolled in the LAARGE study were assigned to two groups depending on initial post-implantation antithrombotic regime consisting of either AC or APT. Selection of antithrombotic medication was at the discretion of the treating center and/or physician. RESULTS: From July 2014 until January 2016, a total of 627 patients at 38 centers were included. A total of 75 patients (12%) received AC and 552 patients (88%) received APT, respectively. No significant differences were found between the groups regarding the composite of death, stroke and systemic embolism 1 year after LAA closure (Kaplan-Meier estimated rate 9.4% for AC vs. 12.8% for APT; p log rank = 0.45). With respect to bleeding events also, no differences were observed 1 year after the procedure (major bleeding 4.0% vs. 2.0%, p = 0.23; moderate bleeding 4.0% vs. 4.9%, p = 1.00; any bleeding 8.0% vs. 6.9%, p = 0.73). CONCLUSIONS: Postprocedural antithrombotic treatment with AC and APT showed comparable results regarding the composite of death, stroke, and systemic embolism as well as regarding bleeding complications after LAA closure in a real-world all-comers population.

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.

New onset atrial fibrillation after patent foramen ovale closure.

OBJECTIVES: In this study, we evaluated the incidence of new onset atrial fibrillation (symptomatic or detected by routine ECG) after patent foramen ovale (PFO-) closure. BACKGROUND: Although atrial fibrillation is known to occur in some patients following patent foramen ovale closure, the incidence and the risk associated with each device is not well known. METHODS: We evaluated 1,349 consecutive patients who underwent PFO closure with an approved device and examined the incidence and risk factors associated with the development of atrial fibrillation. The patients had a mean age of 50 years and underwent PFO closure for cerebrovascular accident in 696 (51.6%), transient ischemic attack in 610 (45.2%), paradoxical embolism in 22 (1.6%), decompression sickness in 13 (0.9%), and other reasons including migraine headaches in 6 (0.4%) of cases. RESULTS: Over a mean follow-up period of 38.1 +/- 28 months, 53 (3.9%) patients developed new onset atrial fibrillation, which is higher compared with an age-matched population. Of these, 33 (62.3%) patients developed atrial fibrillation within 4 weeks and 8 (15%) within 6 months following PFO closure (totally 77% from 0 to 6 months). The event consisted of a single paroxysm lasting less than 48 hr in 23 patients, resolving either spontaneously or with cardioversion. 40 (75.5%) patients were symptomatic at the time of diagnosis. Thirty (56.6%) patients developed chronic atrial fibrillation. On multivariate analysis, advanced age and use of the STARFlex device predicted atrial fibrillation. CONCLUSIONS: The number of patients in whom atrial fibrillation was detected was relatively low. It is often a self-limited complication of PFO closure that may occur more frequently in elderly patients and those treated with the STARFlex device.

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.

Predictors of minor versus major stroke during carotid artery stenting: results from the carotid artery stenting (CAS) registry of the Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte (ALKK).

BACKGROUND: Patient outcome, quality of life as well as health care costs differ between patients with minor versus major stroke during carotid artery stenting. Evaluation of predictors for both subtypes of strokes is of paramount importance. METHODS AND RESULTS: We analyzed data from the prospective, web-based German carotid artery stenting (CAS) registry. All patients entered in this registry were included as of January 2011. During the periprocedural period (until patient discharge or transfer) 1.5 % of the patients (85/5,794) sustained a major and 1.3 % (75/5,784) a minor stroke (total periprocedural stroke rate 2.8 %). Mean age of all patients was 71 years, 72 % were male and 50 % had a symptomatic carotid stenosis. Regression analysis identified age (OR 1.44; 95 % CI 1.05-1.98), symptomatic stenosis (OR 3.17; 95 % CI 1.74-5.76) and procedural duration per 10 min (OR 1.22; 95 % CI 1.13-1.31) as independent predictors for major strokes. Age (OR 1.43; 95 % CI 1.03-1.98), diabetes (OR 1.75; 95 % CI 1.04-2.94), and procedural duration (OR 1.17; 95 % CI 1.08-1.27) predicted for minor strokes. The use of an embolic protection device significantly prevented both type of strokes (OR 0.31; 95 % CI 0.15-0.62 for major strokes; OR 0.40; 95 % CI 0.18-0.91 for minor strokes), female patients suffered less major strokes (OR 0.47; 95 % CI 0.24-0.92). Moreover, minor and major strokes were associated with death, contralateral embolism and a longer hospital stay more frequently. CONCLUSION: Patients with one or more risk factors for periprocedural stroke seem to require special attention in terms of optimal preprocedural assessment of the carotid stenosis and vascular anatomy, as well as adequate patient preparation. Identifying these risk factors may help in patient selection, encourage further refinement in carotid artery stenting technique and avoid procedural complications. The use of an embolic protection device system was associated with less periprocedural minor and major strokes.

The role of endovascular expertise in carotid artery stenting: results from the ALKK-CAS-Registry in 5,535 patients.

PURPOSE: Several scientific committees have proposed an accentuation of operator minimal requirements before accreditation for carotid artery stenting is granted. The current study aims to identify potential effects from increasing site experience on periprocedural safety and outcome of carotid artery stenting (CAS). METHODS: Between 1996 and December 2009, 5,535 procedures have been entered into the prospective, controlled ALKK-CAS-Registry. The total cohort was divided in four subgroups according to the consecutive patient order at each participating center: patients 1-49 (n = 1,485), 50-99 (n = 1,118), 100-199 (n = 1,521) and ≥200 (n = 1,411). RESULTS: The median age of all patients was 71 years; 52.8 % had a symptomatic carotid stenosis. A decline in the rates of in-hospital major stroke (2.1, 1.9, 1.6, 0.9, p for trend 0.014) and of ipsilateral strokes (3.1, 2.4, 2.5, 1.6 %, p for trend 0.019) was substantiated with increasing site experience. This significant trend was preserved in the combined rate of major stroke and death (4.0, 3.2, 3.4, 2.4 %, p for trend 0.034). Apart from CAS experience, improvements in CAS technique, a decreasing number of symptomatic patients and an increasing number of procedures under embolic protection (each p for trend <0.05) might have contributed to these results. CONCLUSIONS: The results show a gradual reduction of in-hospital stroke rates with increasing center experience. Extensive supervision of CAS learners and further promotion of proctorship programs seem to be essential.

Painful congestion of the lower limbs and recurrent fever.

We describe a 45-year-old patient with massive pain and congestion in the lower limbs. In addition, he daily presented fever up to 39.5°C (103.1°F) without any infectious focus for 8 days. A formerly unknown vena cava atresia with severe bilateral deep vein thrombosis and concomitant heterozygous prothrombin (factor II) gene mutation (G20210A) was diagnosed during the hospital stay. Because of the severe clinical findings and hereditary thrombophilia, we recommended a lifelong anticoagulant therapy and elastic stockings. Furthermore, different diagnosis and treatment strategies are discussed in case of concomitant prothrombin gene mutation.

Patent foramen ovale closure with the SeptRx device initial experience with the first "In-Tunnel" device.

OBJECTIVES: The purpose of this study was to evaluate the safety and effectiveness of the SeptRx patent foramen ovale (PFO) closure device (SeptRx, Inc., Fremont, California). BACKGROUND: A PFO is a relatively common remnant of the fetal circulation that can be associated with cryptogenic stroke, transient ischemic attack, migraine, or decompression sickness. Percutaneous PFO closure with different devices has been performed for many years. However, most of the common devices leave a relatively large amount of material in the left and right atria. The SeptRx PFO device (SeptRx, Inc.) is the first PFO closure device designed to fit directly into the pocket of the PFO. METHODS: From July 2006 to May 2007, 13 patients between 18 and 65 years of age with a history of cryptogenic stroke or transient ischemic attack were included into this first-in-man trial. All patients received 100 mg aspirin and 75 mg clopidogrel for 6 months. Follow-up was done at 1 and 6 months after procedure with transesophageal echocardiography and transcranial Doppler. RESULTS: In 11 of 13 patients, PFO closure with the SeptRx device was successfully performed. In 2 patients, PFO closure with this device was not possible due to the anatomy of the PFO; 1 device was retrieved before release, and the other was recaptured with a snare. After 30 days, 6 of the 11 PFOs were closed; after 6 months, all were closed. No adverse events occurred. CONCLUSIONS: The SeptRx PFO closure device appears to be safe and effective. The advantage of this occluder is that there is only minimal foreign material on the left and right sides of the interatrial septum. This is the first such "in-tunnel" PFO closure device.

Late complications of transcatheter closure of patent foramen ovale: new technology and new outcomes.

As a method to prevent recurrent paradoxical embolism and therefore cryptogenic stroke, catheter-based patent foramen ovale closure was first reported in 1992. Since then numerous different devices have been designed to prevent paradoxical embolism. The development of new devices has risen pretty rapidly. Currently, no device can be regarded as the gold standard. Prospective randomized trials comparing interventionalpatent foramen ovale closure with medical treatment are still lacking. The primary aim is to create a device which is easy to implant and able to prevent paradoxical embolism. Additional goals are to minimize early and late complications, such as thrombembolism, erosion of adjacent structures, thrombus formation or atrial arrhythmia. This review gives an overview of the data and the current literature regarding long-term complications (follow-up > or = 1 month) after patent foramen ovale closure with current devices and presents the initial, midterm and late results after patent foramen ovale closure with newer devices.