Safety and performance of a novel cerebral embolic protection device for transcatheter aortic valve implantation: the PROTEMBO C Trial.

BACKGROUND: Stroke remains a feared complication associated with transcatheter aortic valve implantation (TAVI). Embolic cerebral injury occurs in the majority of TAVI cases and can lead to cognitive dysfunction. AIMS: The PROTEMBO C Trial evaluated the safety and performance of the ProtEmbo Cerebral Protection System in TAVI patients. METHODS: Forty-one patients were enrolled in this single-arm study conducted at 8 European centres. The primary safety endpoint was the rate of VARC 2-defined major adverse cardiac and cerebrovascular events (MACCE) at 30 days; the primary performance endpoint was the composite rate of technical success versus performance goals (PG). Secondary endpoints included brain diffusion-weighted magnetic resonance imaging (DW-MRI), new lesion volume, and the rate of death or all strokes compared to historical data. RESULTS: Thirty-seven of 41 enrolled patients underwent TAVI with the ProtEmbo device (intention-to-treat [ITT] population). Both primary endpoints were met. MACCE at 30 days was 8.1% (upper limit of the 95% confidence interval [CI]: 21.3% vs PG 25%; p=0.009), and technical success was 94.6% (lower limit of the 95% CI: 82.3% vs PG 75%; p=0.003). New DW-MRI lesion volumes with ProtEmbo were smaller than in historical data, and 87% of patients completing MRI follow-up had no single lesion >150 mm3. There was 1 stroke in a patient in whom the device was removed prematurely before TAVI completion. CONCLUSIONS: The PROTEMBO C Trial met its primary safety and performance endpoints compared to prespecified historical PGs. Patients had smaller brain lesion volumes on DW-MRI compared to prior series and no larger single lesions. These results warrant further evaluation of the ProtEmbo in a larger randomised controlled trial (RCT).

Comparison and Analysis between the NAV6 Embolic Protection Filter and SpiderFX EPD Filter in Superficial Femoral Artery Lesions.

OBJECTIVE: To compare the safety and efficacy between the SpiderFX EPD and Emboshield NAV6 filter in the collection of embolic debris created from lower limb atherectomy procedures in patients with PAD. MATERIALS AND METHODS: Between January 2014 and October 2015, 507 patients with symptomatic peripheral artery disease were treated with directional atherectomy (SilverHawk), rotational atherectomy (JetStream), or laser atherectomy (Turbo Elite) based on operator discretion. Emboshield NAV6 (n = 161) and SpiderFX (n = 346) embolic protection devices were used with each of the 3 atherectomy devices. The primary study endpoint was 30-day freedom from major adverse events (MAEs). An MAE was defined as death, MI, TVR, thrombosis, dissection, distal embolization, perforation at the level of the filter, and unplanned amputation. A descriptive comparison of the MAE rates between Emboshield NAV6 and SpiderFX embolic protection devices was conducted. RESULTS: The freedom from major adverse event (MAE) rate was 92.0% (CI: 86.7%, 95.7%) in patients who received an Emboshield NAV6 filter compared to 91.6% (CI: 88.2%, 94.3%) in patients who received the SpiderFX filter (p=0.434). The lower limit of 86.7% freedom from major adverse event rate in the Emboshield NAV6 group was above the performance goal of 83% (p < 0.0008). CONCLUSIONS: There were no significant clinical outcome differences between Emboshield NAV6 and SpiderFX EPD filters in the treatment of lower extremities. This evaluation indicates the safety and efficacy to use either filter device to treat PAD patients with lower extremity lesions.

Cerebral Embolic Protection and Outcomes of Transcatheter Aortic Valve Replacement: Results From the Transcatheter Valve Therapy Registry.

BACKGROUND: Stroke remains a devastating complication of transcatheter aortic valve replacement (TAVR), which has persisted despite refinements in technique and increased operator experience. While cerebral embolic protection devices (EPDs) have been developed to mitigate this risk, data regarding their impact on stroke and other outcomes after TAVR are limited. METHODS: We performed an observational study using data from the Society for Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. Patients were included if they underwent elective or urgent transfemoral TAVR between January 2018 and December 2019. The primary outcome was in-hospital stroke. To adjust for confounding, the association between EPD use and clinical outcomes was evaluated using instrumental variable analysis, a technique designed to support causal inference from observational data, with site-level preference for EPD use within the same quarter of the procedure as the instrument. We also performed a propensity score-based secondary analysis using overlap weights. RESULTS: Our analytic sample included 123 186 patients from 599 sites. The use of EPD during TAVR increased over time, reaching 28% of sites and 13% of TAVR procedures by December 2019. There was wide variation in EPD use across hospitals, with 8% of sites performing >50% of TAVR procedures with an EPD and 72% performing no procedures with an EPD in the last quarter of 2019. In our primary analysis using the instrumental variable model, there was no association between EPD use and in-hospital stroke (adjusted relative risk, 0.90 [95% CI, 0.68-1.13]; absolute risk difference, -0.15% [95% CI, -0.49 to 0.20]). However, in our secondary analysis using the propensity score-based model, EPD use was associated with 18% lower odds of in-hospital stroke (adjusted odds ratio, 0.82 [95% CI, 0.69-0.97]; absolute risk difference, -0.28% [95% CI, -0.52 to -0.03]). Results were generally consistent across the secondary end points, as well as subgroup analyses. CONCLUSIONS: In this nationally representative observational study, we did not find an association between EPD use for TAVR and in-hospital stroke in our primary instrumental variable analysis, and found only a modestly lower risk of in-hospital stroke in our secondary propensity-weighted analysis. These findings provide a strong basis for large-scale randomized, controlled trials to test whether EPDs provide meaningful clinical benefit for patients undergoing TAVR.

Very Low Rate of New Brain Lesions After Vulnerable Carotid Artery Stenting Cases Using Only FilterWire EZ as Distal Embolic Protection.

BACKGROUND: Although carotid artery stenting (CAS) has been widely acknowledged as an effective alternative option for patients at high risk of carotid endarterectomy, embolic stroke is a major complication of CAS. Several reports have emphasized that distal protection filter alone is associated with a high risk of embolic complications of CAS with vulnerable plaque. Thus, relatively complicated protection systems have recently been recommended to prevent distal embolic complications. However, those protection systems require many steps, which, themselves, can also cause complications. The FilterWire EZ embolic protection device (EPD) for use in CAS was approved for national health insurance coverage in Japan in 2010. Since then, we have been using it as an EPD in all CAS procedures, even those with vulnerable plaque. METHODS: The medical records of 80 patients who had undergone CAS from February 2014 to September 2019 at Moriyama Memorial Hospital were retrospectively reviewed. Emergent cases with distal mechanical thrombectomy were not included. We enrolled patients whose target lesion was vulnerable as evaluated by magnetic resonance imaging and who had undergone diffusion-weighted imaging studies the next day. RESULTS: Of the 80 patients, 60 had met the inclusion criteria. No symptomatic embolic complications developed, and only 5 patients (8.3%) had shown new lesions on diffusion-weighted imaging after CAS. The rate of new lesions after CAS with vulnerable plaque was much lower than that in previous studies. We meticulously analyzed the data to determine the predictive factors. CONCLUSION: The FilterWire EZ as an EPD for CAS is quite safe, even for vulnerable carotid stenosis.

Cumulative incidence of restenosis in the endovascular treatment of extracranial carotid artery stenosis: a meta-analysis.

OBJECTIVE: To assess the cumulative incidence of restenosis and stroke after stenting for cervical carotid artery stenosis. METHODS: We reviewed PubMed, ScienceDirect, and Scopus and included all studies reporting restenosis after stenting. The cumulative incidence of restenosis at 6 and 12 months was calculated. We also estimated the cumulative incidence of ipsilateral stroke within 30 days after stenting. Random effect meta-analysis and meta-regression were performed using relevant study level covariates. Sources of heterogeneity were investigated. RESULTS: Among 7765 records, 40 studies were selected. 15 943 patients and 16 337 carotid arteries were considered. The overall pooled cumulative incidence of restenosis >50% at 12 months was 5.7% (95% CI 3.8% to 8.6%), >70% at 12 months was 5.2% (95% CI 3.3% to 8.2%), >50% at 6 months was 3.9% (95% CI 2.2% to 6.8%), and ipsilateral stroke within 30 days after stenting was 1.6% (95% CI 1.0% to 2.5%) without association with the use of an embolic protection device. We did not identify any relevant source of heterogeneity of the cumulative incidence of restenosis >50% at 12 months. Mean age explained 80.9% (R2=80.9%, p=0.01) of heterogeneities of restenosis >70% at 12 months. The presence of hostile neck explained 53.9% (R2=53.9%, p=0.03) of heterogeneities of restenosis >50% at 6 months. CONCLUSION: This meta-analysis showed a low cumulative rate of restenosis at 12 months and ipsilateral stroke within 30 days after stenting. Older patients and those with hostile neck present a lower risk of in-stent restenosis. The use of an embolic protection device was not associated with a lower risk of stroke.

Effect of Cerebral Embolic Protection Devices on CNS Infarction in Surgical Aortic Valve Replacement: A Randomized Clinical Trial.

Importance: Stroke is a major complication of surgical aortic valve replacement (SAVR). Objective: To determine the efficacy and adverse effects of cerebral embolic protection devices in reducing ischemic central nervous system (CNS) injury during SAVR. Design, Setting, and Participants: A randomized clinical trial of patients with calcific aortic stenosis undergoing SAVR at 18 North American centers between March 2015 and July 2016. The end of follow-up was December 2016. Interventions: Use of 1 of 2 cerebral embolic protection devices (n = 118 for suction-based extraction and n = 133 for intra-aortic filtration device) vs a standard aortic cannula (control; n = 132) at the time of SAVR. Main Outcomes and Measures: The primary end point was freedom from clinical or radiographic CNS infarction at 7 days (± 3 days) after the procedure. Secondary end points included a composite of mortality, clinical ischemic stroke, and acute kidney injury within 30 days after surgery; delirium; mortality; serious adverse events; and neurocognition. Results: Among 383 randomized patients (mean age, 73.9 years; 38.4% women; 368 [96.1%] completed the trial), the rate of freedom from CNS infarction at 7 days was 32.0% with suction-based extraction vs 33.3% with control (between-group difference, -1.3%; 95% CI, -13.8% to 11.2%) and 25.6% with intra-aortic filtration vs 32.4% with control (between-group difference, -6.9%; 95% CI, -17.9% to 4.2%). The 30-day composite end point was not significantly different between suction-based extraction and control (21.4% vs 24.2%, respectively; between-group difference, -2.8% [95% CI, -13.5% to 7.9%]) nor between intra-aortic filtration and control (33.3% vs 23.7%; between-group difference, 9.7% [95% CI, -1.2% to 20.5%]). There were no significant differences in mortality (3.4% for suction-based extraction vs 1.7% for control; and 2.3% for intra-aortic filtration vs 1.5% for control) or clinical stroke (5.1% for suction-based extraction vs 5.8% for control; and 8.3% for intra-aortic filtration vs 6.1% for control). Delirium at postoperative day 7 was 6.3% for suction-based extraction vs 15.3% for control (between-group difference, -9.1%; 95% CI, -17.1% to -1.0%) and 8.1% for intra-aortic filtration vs 15.6% for control (between-group difference, -7.4%; 95% CI, -15.5% to 0.6%). Mortality and overall serious adverse events at 90 days were not significantly different across groups. Patients in the intra-aortic filtration group vs patients in the control group experienced significantly more acute kidney injury events (14 vs 4, respectively; P = .02) and cardiac arrhythmias (57 vs 30; P = .004). Conclusions and Relevance: Among patients undergoing SAVR, cerebral embolic protection devices compared with a standard aortic cannula did not significantly reduce the risk of CNS infarction at 7 days. Potential benefits for reduction in delirium, cognition, and symptomatic stroke merit larger trials with longer follow-up. Trial Registration: clinicaltrials.gov Identifier: NCT02389894.

Delayed extrusion of embolic coils into the airway after embolization of an external carotid artery pseudoaneurysm.

Carotid blowout syndrome (CBS) is a known devastating complication of head and neck surgery. The risk of developing CBS increases in the setting of radiation therapy, wound breakdown, or tumor recurrence. Traditionally, the treatment of choice for CBS is surgical ligation of the bleeding artery; however, recently, endovascular occlusion has become a more common option. If a pseudoaneurysm is present, treatment consists of trapping with endovascular coils or occlusion with a liquid embolic agent. Delayed migration of embolization coils into the airway causing acute respiratory distress is a rare occurrence. This report presents a case of a 57-year-old woman who presented to her otolaryngologist after experiencing an episode of acute respiratory distress which resolved when she expectorated embolization coil material from her tracheostomy tube. Three months prior to the episode she underwent coil embolization of an external carotid artery pseudoaneurysm for life-threatening hemorrhage.

Acute distal migration of a flow diverting stent.

The introduction of flow diverting stents, particularly for treatment of petrous to supraclinoid internal carotid artery aneurysms, has greatly impacted endovascular treatment of intracranial aneurysms. Despite their high efficacy, complications, such as ischemic events, distal hemorrhage, or problems with stent deployment, remain a significant concern. We present the first reported case of acute distal migration of a Pipeline Embolization Device (PED). A 24-year old female underwent elective placement of a PED for treatment of a left paraclinoid internal carotid artery aneurysm. Despite an uneventful intra-operative course, adequate stent placement and a normal neurologic examination immediately after placement, she demonstrated right hemiparesis shortly thereafter. Repeat angiography revealed acute distal migration of the PED and an occlusive thrombus. Thought to be secondary to chronic in-stent thrombosis, distal migration has been previously described in a delayed fashion over weeks to months. However, to our knowledge, this is the first reported case of distal flow diverter migration in an acute setting immediately following the procedure.

Left atrial anatomy and patient-related factors associated with adverse outcomes with the watchman device-a real world experience.

OBJECTIVE: This study sought to identify patient and left atrial morphology specific factors associated with early complications for left atrial appendage occlusion with the Watchman™ (Boston Scientific, Natick, MA) device. BACKGROUND: Oral anticoagulation (OAC) is recommended for patients with atrial fibrillation, however, long-term OAC compliance is poor. In randomized control trials, the Watchman™ device has demonstrated superiority over OAC with warfarin for all cause and cardiovascular mortality and hemorrhagic stroke. However, predictors of procedural complications have not yet been well established. METHODS: There were 137 patients included in this study from a total of 141 consecutive patients prospectively enrolled in the registry between 8/1/2015 and 08/31/2016. Unadjusted, multivariate cox proportional hazards model was used for analysis. Primary end-point was a composite major adverse cardiac and cerebrovascular event (MACCE) defined to include death, stroke, major and life threatening bleeding, major vascular complications, device embolization, need for cardiovascular surgery, need for cardiopulmonary resuscitation, and significant pericardial effusion. RESULTS: The primary endpoint was reached in 5.8% of patients. There were no device embolization and no strokes. Anterior chicken morphology (ACW) of the left atrial appendage (LAA) conferred a hazard ratio of 3.7 for MACCE and a body mass index >30 kg/m2 significantly lowered the likelihood of a MACCE. CONCLUSION: Certain LAA morphologies and patient characteristics increase the risk for a MACCE following left atrial appendage occlusion (LAAO) with the Watchman™ device. Anterior chicken wing morphology of the LAA and low BMI <30 kg/m2 were independent predictors of MACCE in the multivariate regression model.

Immunohistochemical Analysis of Debris Captured by Filter-Type Distal Embolic Protection Devices for Carotid Artery Stenting.

BACKGROUND: Little is known about the micro-debris captured in filter-type distal embolic protection devices (EPD) used for carotid stenting (CAS). This study aimed to determine the histological and immunohistochemical characteristics of such debris by using a new liquid-based cytology (LBC) technique. METHODS: Fifteen patients who underwent CAS using a filter-type distal EPD (FilterWire EZ; Boston Scientific, Marlborough, MA, USA) were included in the study. After gross inspection of each recovered filter device, micro-debris were collected using a new LBC technique (SurePath; TriPath Imaging, Inc., Burlington, NC). Histological and immunohistochemical analysis of the recovered debris was performed. The pre- and postoperative brain magnetic resonance imaging and neurological status of each patient were also reviewed. RESULTS: No patient developed ipsilateral symptomatic stroke due to a thromboembolic event. All 15 patients (100%) had microscopically identifiable debris in the filters, whereas gross inspection detected visible debris only in 5 patients (33.3%). Histological analysis revealed various types of structural components in an advanced atheromatous plaque, including fragments of fibrous cap, calcified plaque, smooth muscle cells, and necrotic tissue fragment infiltrated with monocytes and macrophages. CONCLUSIONS: Filter-type EPDs may contribute to reducing the risk of CAS-related embolic events by capturing micro-debris even when gross inspection of the recovered filter shows no visible debris in the device.

Transesophageal echocardiographic diagnosis of a WATCHMAN left atrial appendage closure device thrombus 10 years following implantation.

Left atrial appendage closure with the WATCHMAN device is an alternative to chronic oral anticoagulation for thromboembolic prophylaxis in atrial fibrillation patients. Left atrial device-related thrombus (DRT) has been described in the first year after implant with an incidence of ~6%. A 79-year-old man underwent WATCHMAN device placement in 2006. Routine protocol specified follow-up transesophageal echocardiograms (TEE) at 6 weeks, 6 months, and 1 year following implant showed no evidence for DRT or peri-device flow. A decade after device implant, the patient presented with severe symptomatic aortic stenosis and underwent repeat TEE, which revealed a 21 mm × 18 mm DRT on the LA aspect of the WATCHMAN device. He was prescribed apixaban 5 mg po BID. A TEE performed 111 days later demonstrated marked diminution in the DRT (9 mm in diameter). This case demonstrates that WATCHMAN DRT may occur late following implantation.

Subclinical ischemic events in patients undergoing carotid artery stent placement: comparison of proximal and distal protection techniques.

OBJECTIVE: To determine the relative effectiveness of proximal and distal protection in prevention of cerebral ischemic events during carotid artery stent (CAS) placement using diffusion-weighted MRI (DW-MRI). METHODS: We analyzed data from patients who had undergone DW-MRI before and within 24 hours of CAS for symptomatic internal carotid artery (ICA) stenosis (with last ischemic events within 3 months). The study was performed prospectively; patients were not randomized, and were treated either with a proximal balloon occlusion system (Mo.Ma; Invatec, Roncadelle, Italy) or filter-type distal protection device (Spider device; ev3, Plymouth, Minnesota, USA). RESULTS: Of the 45 patients (mean age±SD: 66.9±9.8 years; 73.3% were men) who underwent CAS, 19 had proximal protection and 26 distal protection. New ischemic lesions were detected in 26/45 patients on DW-MRI scans obtained within 24 hours after CAS. The proportion of patients with new lesions on DW-MRI at 24 hours was not different between the two groups (47.4% vs 65.4% for proximal and distal protection, respectively). The mean number of new ischemic lesions on post-CAS DW-MRI was non-significantly higher in patients who underwent CAS with distal protection (2.80±3.54 for proximal protection vs 4.96±5.11 for distal protection; p=0.12). The proportion of patients with new lesions >1 cm did not differ between the two groups (5.3% for proximal protection vs 11.5% for distal protection; p=0.62). There was no difference in the rates of ischemic stroke between patients who underwent CAS treatment using proximal and distal protection (5.3% vs 7.7%; p=1.000). CONCLUSIONS: We found a relatively high rate of new ischemic lesions in patients undergoing CAS with cerebral protection. There was no difference in the proportion of patients with new lesions between patients treated using distal protection and those treated using proximal protection.

Effect of a Cerebral Protection Device on Brain Lesions Following Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Stenosis: The CLEAN-TAVI Randomized Clinical Trial.

IMPORTANCE: Stroke remains a major predictor of mortality after transcatheter aortic valve implantation (TAVI). Cerebral protection devices might reduce brain injury as determined by diffusion-weighted magnetic resonance imaging (DWMRI). OBJECTIVE: To determine the effect of a cerebral protection device on the number and volume of cerebral lesions in patients undergoing TAVI. DESIGN, SETTING, AND PARTICIPANTS: Investigator-initiated, single center, blinded, randomized clinical trial in higher-risk patients with severe aortic stenosis undergoing TAVI at the University of Leipzig Heart Center. Brain MRI was performed at baseline, 2 days, and 7 days after TAVI. Between April 2013 and June 2014, patients were randomly assigned to undergo TAVI with a cerebral protection device (filter group) or without a cerebral protection device (control group). The last 1-month follow-up occurred in July 2014. INTERVENTIONS: TAVI with or without a cerebral protection device (filter system). MAIN OUTCOMES AND MEASURES: The primary end point was the numerical difference in new positive postprocedure DWMRI brain lesions at 2 days after TAVI in potentially protected territories. The first hierarchical secondary outcome was the difference in volume of new lesions after TAVI in potentially protected territories. RESULTS: Among the 100 enrolled patients, mean (SD) age was 80.0 (5.1) years in the filter group (n = 50) and 79.1 (4.1) years in the control group (n = 50), and the mean (SD) procedural risk scores (logistic EuroScores) were 16.4% (10.0%) in the filter group and 14.5% (8.7%) in the control group. For the primary end point, the number of new lesions was lower in the filter group, 4.00 (interquartile range [IQR], 3.00-7.25) vs 10.00 (IQR, 6.75-17.00) in the control group (difference, 5.00 [IQR, 2.00-8.00]; P < .001). For the first hierarchical secondary end point, new lesion volume after TAVI was lower in the filter group (242 mm3 [95% CI, 159-353]) vs in the control group (527 mm3 [95% CI, 364-830]) (difference, 234 mm3 [95% CI, 91-406]; P = .001). Considering adverse events, 1 patient in the control group died prior to the 30-day visit. Life-threatening hemorrhages occurred in 1 patient in the filter group and 1 in the control group. Major vascular complications occurred in 5 patients in the filter group and 6 patients in the control group. One patient in the filter group and 5 in the control group had acute kidney injury, and 3 patients in the filter group had a thoracotomy. CONCLUSIONS AND RELEVANCE: Among patients with severe aortic stenosis undergoing TAVI, the use of a cerebral protection device reduced the frequency of ischemic cerebral lesions in potentially protected regions. Larger studies are needed to assess the effect of cerebral protection device use on neurological and cognitive function after TAVI and to devise methods that will provide more complete coverage of the brain to prevent new lesions. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01833052.

Safety and Effectiveness of the Nav-6 Filter in Preventing Distal Embolization During Jetstream Atherectomy of Infrainguinal Peripheral Artery Lesions.

BACKGROUND: The risk of distal embolization (DE) during infrainguinal peripheral artery interventions (PAI) is often mitigated by the use of embolic protection devices. There are limited data on the use of filters with the Jetstream (JS) atherectomy device, a rotational cutter with aspiration capacity. The Nav-6 filter is uniquely suited for use with the JS due to its wire compatibility and detachment from the filter; however, data on the off-label use of this combination have not been reported. METHODS: Consecutive patients between October 2008 and April 2015 undergoing endovascular infrainguinal PAI with JS were analyzed as part of the Excellence in Peripheral Artery Disease (XL-PAD) registry (NCT01904851). Patients were divided into two subgroups with Nav-6 filter use vs no filter use. Descriptive and univariate analyses were performed. RESULTS: Among 141 patients (mean age, 67.8 ± 10.8 years; 169 lesions) included in this study, the Nav-6 filter was used in 82 (59%). Use of a filter was more frequent in longer lesions (146 ± 106 mm vs 91 ± 72 mm; P=.01), in more severe stenoses (95% vs 87%; P=.04), and in chronic total occlusions (33% vs 8.3%; P=.01). Patients receiving filters had longer procedure duration (102 ± 51 min vs 66 ± 41 min; P=.01) and longer fluoroscopy times (31 ± 16 min vs 21 ± 10 min; P<.001). Use of the Nav-6 filter with the JS during PAI was associated with numerically lower rates of DE (1.8% vs 8%; P=.10) and similar rates of death and amputation. At 12 months, the target-lesion revascularization rate was higher in the filter group (22% vs 2.7%; P=.02), likely secondary to use of the filter in more complex lesions. CONCLUSION: Nav-6 filter during JS atherectomy was predominantly used during complex infrainguinal PAI and was associated with less occurrence of DE.

Assessment of Device-Related Thrombus and Associated Clinical Outcomes With the WATCHMAN Left Atrial Appendage Closure Device for Embolic Protection in Patients With Atrial Fibrillation (from the PROTECT-AF Trial).

Left atrial appendage closure with the WATCHMAN device is an alternative to anticoagulation for stroke prevention in selected patients with atrial fibrillation (AF). LA device-related thrombus (DRT) is poorly defined and understood. We aimed to (1) develop consensus echocardiographic diagnostic criteria for DRT; (2) estimate the incidence of DRT; and (3) determine clinical event rates in patients with DRT. In phase 1 (training), a training manual was developed and reviewed by 3 echocardiographers with left atrial appendage closure device experience. All available transesophageal (TEE) studies in the WATCHMAN left atrial appendage system for embolic protection in patients with atrial fibrillation (PROTECT-AF) trial patients with suspected DRT were reviewed in 2 subsequent phases. In phase 2 (primary blind read), each reviewer independently scored each study for DRT, and final echo criteria were developed. Unanimously scored studies were considered adjudicated, whereas all others were reevaluated by all reviewers in phase 3 (group adjudication read). DRT was suspected in 35 of 485 patients by the site investigator, the echocardiography core laboratory, or both; 93 of the individual TEE studies were available for review. In phase 2, 3 readers agreed on 67 (72%) of time points. Based on phases 1 and 2, 5 DRT criteria were developed. In phase 3, studies without agreement in phase 2 were adjudicated using these criteria. Overall, at least 1 TEE was DRT positive in 27 (5.7%) PROTECT-AF patients. Stroke, peripheral embolism, or cardiac/unexplained death occurred in subjects with DRT at a rate of 3.4 per 100 patient-years follow-up. In conclusion, DRT were identified on at least 1 TEE in 27 PROTECT-AF patients, indicating a DRT incidence of 5.7%. Primary efficacy events in patients with DRT occurred at a rate of 3.4 per 100 patient-years follow-up, intermediate in frequency between event rates previously reported for the overall device and warfarin arms in PROTECT-AF.

Cerebral Protection During MitraClip Implantation: Initial Experience at 2 Centers.

OBJECTIVES: This study sought to assess the feasibility and safety of using a filter-based cerebral protection system (CPS) during MitraClip implantation and to report on the histopathologic analysis of the captured debris. BACKGROUND: Stroke is one of the serious adverse events associated with MitraClip therapy. METHODS: Between July 2014 and March 2015, 14 surgical high-risk patients (age 75 ± 7 years; 7 men; median logistic EuroSCORE 21%) underwent MitraClip implantation employing cerebral protection with a dual embolic filter system. All patients had severe mitral regurgitation of predominantly functional origin. RESULTS: All procedures were successfully completed for both CPS deployment/retrieval and MitraClip implantation. A total of 28 filters (2 from each patient) were analyzed. Microscopically, debris was identified in all 14 patients. The most common tissue types were acute thrombus and small fragments of foreign material, which were found in 12 patients (85.7%) each. Organizing thrombus was present in 4 patients (28.6%), valve tissue and/or superficial atrial wall tissue in 9 patients (64.3%), and fragments of myocardium in 2 patients (14.3%). No transient ischemic attacks, strokes, or deaths occurred peri-procedurally or during a median follow-up interval of 8.4 months. CONCLUSIONS: In this small study of patients undergoing MitraClip treatment with cerebral protection, embolic debris potentially conducive to cerebrovascular events was found in all patients. Debris was composed most often of acute thrombus, foreign material likely originating from the hydrophilic device coating, and valve/atrial wall tissue. Further studies are warranted to assess the impact of cerebral protection on the incidence of cerebrovascular events after MitraClip therapy.

Prospective comparison of cognitive effects of carotid endarterectomy versus carotid stenting with flow reversal or distal filters.

OBJECTIVE: It is unclear whether carotid revascularization can improve the cognitive problems often observed in patients with carotid stenosis. We examined the presence of preoperative disturbances and the effects of different types of carotid revascularization on cognition. METHOD: Forty-six patients treated for significant carotid stenosis [26 carotid endarterectomy (CEA), 10 transfemoral carotid stenting with distal filters (CASdp), and 10 transcervical stenting with flow reversal (CASfr)] as well as a matched control group of 26 vascular patients without carotid stenosis were included. Patients and controls were tested 1 day preoperatively and 1, 6, and 12 months after surgery on 18 neuropsychological variables. RESULTS: A significant amount of carotid patients as well as vascular controls showed cognitive defects at preoperative testing. None of the neuropsychological variables showed significant group differences between CEA, CASdp, CASfr, and controls, and only 1 revealed interaction between type of revascularization and improvements over time, though this effect dissolved when 2 outliers were excluded. Thirteen of 18 variables showed improved scores over time, regardless of the group. Compared with controls, about 10% of patients showed improvements, while 20% showed cognitive deterioration 6 months after revascularization. CONCLUSIONS: Results show similar effects for CEA, CASdp, and CASfr on cognition. Large practice effects due to repeated testing confirm the importance of using control groups in prospective cognition studies. Because of the small sample size, this study should be regarded as an exploratory study; larger studies on the cognitive consequences of carotid revascularization remain warranted.

The data extraction and longitudinal trend analysis network study of distributed automated postmarket cardiovascular device safety surveillance.

BACKGROUND: Current approaches for postmarket medical device safety surveillance are limited in their ability to produce timely and accurate assessments of adverse event rates. METHODS AND RESULTS: The Data Extraction and Longitudinal Trend Analysis (DELTA) network study was a multicenter prospective observational study designed to evaluate the safety of devices used during percutaneous coronary interventions. All adult patients undergoing percutaneous coronary intervention from January 2008 to December 2012 at 5 participating Massachusetts sites were included. A safety alert was triggered if the cumulative observed adverse event rates for the study device exceeded the upper 95% confidence interval of the event rates of propensity-matched control cohort. Prespecified sensitivity analyses were developed to validate any identified safety signal. A total of 23,805 consecutive percutaneous coronary intervention procedures were evaluated. Two of 24 safety analyses triggered safety alerts. Patients receiving Perclose vascular closure device experienced an increased risk of minor vascular complications (relative risk, 4.14; P<0.01) and any vascular complication (relative risk, 2.06; P=0.01) when compared with propensity-matched patients receiving alternative vascular closure device, a result primarily driven by relatively high event rates at 1 participating center. Sensitivity analyses based on alternative risk adjustment methods confirmed a pattern of increased rate of complications at 1 of the 5 participating sites in their use of Perclose vascular closure device. CONCLUSIONS: The DELTA network study demonstrates that distributed automated prospective safety surveillance has the potential of providing near real-time assessment of safety risks of newly approved medical devices.