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.

Trends in Cerebral Embolic Protection Device Use and Association With Stroke Following Transcatheter Aortic Valve Implantation.

Stroke remains a serious complication of transcatheter aortic valve implantation (TAVI). Prior studies examining the association between cerebral embolic protection device (CEPD) use and stroke following TAVI have produced conflicting results. We used the Nationwide Readmissions Databases to identify all percutaneous (non-transapical) TAVIs performed in the US from July, 2017 to December, 2018. Overlap propensity score weighted logistic regression models were used to determine the association between CEPD use and outcomes. The primary outcome was in-hospital stroke or transient ischemic attack (TIA). Among 50,000 percutaneous TAVIs (weighted national estimate: 88,886 [SE: 2,819]), CEPD was used in 2,433 (weighted national estimate: 3,497 [SE: 857]). Nationally, the utilization rate of CEPD was 3.9% (SE: 0.9%) of all TAVIs during the overall study period, which increased from 0.8% (SE: 0.4%) in 2017Q3 to 7.6% (SE: 1.6%) in 2018Q4 (p<0.001). The proportion of hospitals using CEPD increased from 2.3% in 2017Q3 to 14.7% in 2018Q4 (p<0.001). There were no significant differences in rates of in-hospital stroke/TIA in TAVIs with versus without CEPD (2.6% vs 2.2%; unadjusted OR [95% CI] 1.18 [0.98-1.52]; overlap propensity score weighted OR [95% CI] 1.19 [0.81-1.75]). CEPD use was not associated with statistically significant lower rates of in-hospital stroke, ischemic stroke, hemorrhagic stroke, TIA, all-cause mortality, or discharge to skilled nursing facility. In conclusion, the rates of CEPD utilization and proportion of TAVI hospitals using CEPD increased during the study period. The use of CEPD during TAVI was not associated with statistically significant lower rates of in-hospital stroke, TIA, or mortality.

Rate of peri-procedural stroke observed with cerebral embolic protection during transcatheter aortic valve replacement: a patient-level propensity-matched analysis.

AIMS: The role of cerebral embolic protection (CEP) in transcatheter aortic valve replacement (TAVR) remains controversial. Randomized trials have not been powered to demonstrate a reduction in stroke rates. The aim of this patient level pooled analysis was to validate the impact of the dual-filter CEP device (Claret Medical Inc., CA, USA) on peri-procedural stroke in a large number of TAVR patients. METHODS AND RESULTS: Patients from the SENTINEL US IDE trial were combined with the CLEAN-TAVI and SENTINEL-Ulm study in a patient level pooled analysis (N = 1306). Propensity score matching was performed to adjust for possible confounders. The primary endpoint was procedural stroke within 72 h post-TAVR according to Valve Academic Research Consortium-2 criteria. The secondary endpoint was the combination of all-cause mortality or all-stroke within 72 h after TAVR. In the propensity-matched population, 533 patients underwent TAVR without CEP and 533 patients underwent TAVR with CEP. TAVR patients without vs. with CEP were similar with respect to baseline characteristics, procedural approach, or valve type. In patients undergoing TAVR with dual-filter CEP, procedural all-stroke was significantly lower compared with unprotected procedures [1.88% vs. 5.44%, odds ratio 0.35, 95% confidence interval (CI) 0.17-0.72, relative risk reduction 65%, P = 0.0028]. In addition, all-cause mortality and all-stroke were significantly lower (2.06% vs. 6.00%, odds ratio 0.34, 95% CI 0.17-0.68, relative risk reduction 66%, P = 0.0013). CONCLUSION: Our findings suggest that TAVR with the dual-filter CEP device is associated with a significant lower rate of peri-procedural stroke compared with unprotected procedures. However, randomized trials are still needed to clarify this issue.

Silent cerebral injury after transcatheter aortic valve implantation and the preventive role of embolic protection devices: A systematic review and meta-analysis.

BACKGROUND: The aims of this study were: 1) to evaluate silent cerebral injury detected by cerebral diffusion weighted magnetic resonance imaging (DW-MRI) after transcatheter aortic valve implantation (TAVI); and 2) to assess the efficacy of embolic protection devices (EPDs) on DW-MRI endpoints. METHODS: We included in a pooled analysis 25 prospective studies reporting post-procedural cerebral DW-MRI data after TAVI (n=1225). Among these studies, we included in a meta-analysis 6 studies investigating TAVI performed with versus without EPDs (n=384). Primary endpoints were the number of new lesions per patient and the total lesion volume, while secondary endpoints were the number of patients with new lesions and the single lesion volume. RESULTS: The main pooled DW-MRI outcomes were: patients with new ischemic lesions, 77.5% (95% confidence interval=71.7-83.3%); total lesion volume, 437.5mm(3) (286.7-588.3mm(3)); single lesion volume, 78.1mm(3) (56.7-99.5mm(3)); and number of new lesions per patient, 4.2 (3.4-5.0). The use of EPDs was associated with a significant reduction in total lesion volume (mean difference [95% confidence interval]=-111.1mm(3) [-203.6 to -18.6mm(3)]; p=0.02) and single lesion volume (-12.1mm(3) [-18.3 to -6.0mm(3)]; p=0.0001) after TAVI. CONCLUSIONS: Silent cerebral injury occurs in the majority of patients undergoing TAVI and DW-MRI allows a precise characterization of new ischemic brain lesions. EPDs reduce the total and single volume of such lesions detected after the procedure, although the number of new lesions per patient and the number of patients with new lesions are not significantly reduced by such devices.

Initial Experience Using the Gore Embolic Filter in Carotid Interventions.

BACKGROUND: This is the first clinical report on experience in the use of the Gore embolic filter in carotid interventions. It was designed as a guidewire and embolic protection system in carotid, peripheral, and coronary interventions. The ability to capture debris is driven by the frame of the filter, which is designed to improve vessel wall apposition and allows a short landing zone. METHODS: We report the results of the first 20 consecutive patients undergoing carotid artery stenting using the Gore embolic filter in our institution. We analyzed technical success as well as the occurrence of transient ischemic attack (TIA), stroke, or death periprocedurally and through 30 days of follow-up. Mean patient age was 72 years and 12 patients (60%) were male. Seven patients were symptomatic and 4 patients suffered recurrent neurological events. RESULTS: Technical success was achieved in all procedures. In 1 patient, the retrieval catheter was caught between the proximal struts of the stent and required further retrieval maneuvers. Within 30 days of follow-up, 1 patient had a TIA. No stroke, death, or myocardial infarction occurred. CONCLUSION: This initial experience suggests that the Gore embolic filter device can be used safely for distal embolic protection during carotid stenting procedures with high technical success.

Impact of Distal Protection with Filter-Type Device on Long-term Outcome after Percutaneous Coronary Intervention for Acute Myocardial Infarction: Clinical Results with Filtrap®.

AIM: Although distal embolization during percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) deteriorates cardiac function, whether distal protection (DP) can improve prognosis is still controversial. We investigated whether a filter-type DP device, Filtrap®, could improve long-term outcomes after PCI for AMI. METHOD: We studied 164 patients (130 men, mean age: 65.7 years) who underwent PCI. Patients were divided into two groups based on the use of Filtrap®. The occurrence of congestive heart failure (CHF) and major adverse cardiac events (MACE) defined as cardiac death, recurrent AMI, and target vessel revascularization were compared. RESULT: Between DP (n=53, 41 men, mean age: 65.5 years) and non-DP (n=111, 89 men, mean age: 65.8 years) groups, although there was significantly greater plaque area in the DP group than in the non-DP group, there were no significant differences in coronary reperfusion flow after PCI. Interestingly, patients with CHF in the non-DP group exhibited a higher CK level than those in the DP group. During a 2-year follow-up period, cumulative CHF was significantly lower in the DP group than in the non-DP group (log-rank p=0.018), and there was no significant difference in the MACE rate (log-rank p=0.238). The use of DP device could not predict MACE, but could predict CHF by multivariate analysis (odds ratio=0.099, 95% CI: 0.02-0.42, p=0.005). CONCLUSION: These results demonstrate that favorable clinical outcomes could be achieved by the filter-type DP device in AMI, particularly in patients with CHF.

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.

Proximal versus distal embolic protection for carotid artery stenting: a national cardiovascular data registry analysis.

OBJECTIVES: The aim of this study was to compare the stroke/death rates between proximal embolic protection devices (P-EPDs) and distal filter embolic protection devices (F-EPDs) in elective carotid artery stenting (CAS). BACKGROUND: P-EPDs have theoretical advantages that may make them superior to F-EPDs for stroke prevention during CAS. METHODS: We examined 10,246 consecutive elective CAS procedures performed with embolic protection in the NCDR CARE registry between January 2009 and March 2013. We analyzed crude and propensity-matched rates of in-hospital combined death/stroke in patients treated with P-EPDs versus F-EPDs. Secondary analyses included 30-day adverse event rates and stroke rates by the involved cerebrovascular territory. RESULTS: P-EPDs were used in 590 of 10,246 cases (5.8%). Patients treated with P-EPDs had higher rates of symptomatic lesion status (46.8% vs. 39.7%, p<0.001), atrial fibrillation/flutter (16.1% vs. 13.0%, p=0.03), and history of a neurological event (51.2% vs. 46.6%, p=0.03). In unadjusted and propensity-matched analyses, differences in in-hospital stroke/death between P-EPD and F-EPD cohorts were nonsignificant (1.5% vs. 2.4%, p=0.16 and 1.6% vs. 2.0%, p=0.56, respectively). For patients with available data (n=7,693, 75.1%), 30-day adverse events rates were similar for P-EPDs and F-EPDs before (2.5% vs. 4.2%, p=0.07) and after (2.7% vs. 4.0%, p=0.22) propensity matching. CONCLUSIONS: Use of a P-EPD during CAS was associated with low rates of in-hospital stroke/death similar to those with an F-EPD in the first comparative effectiveness study of the devices. An adequately powered randomized trial comparing clinical outcomes between these devices is unlikely to be feasible.

Percutaneous extraction of inadvertently placed left-sided pacemaker leads with complete cerebral embolic protection.

Lead wire malposition is a known, but rare complication of permanent pacemaker or defibrillator implantation. The actual incidence and prevalence is unknown and management options for inadvertent left ventricular lead malposition have not been uniform. Current recommendations include systemic anticoagulation with warfarin or surgical lead removal with circulatory arrest for compelling clinical scenarios. Percutaneous left-sided lead extraction is contraindicated due to the potentially increased risk of thromboembolic complications associated with this procedure. To our knowledge, this is the first report of percutaneous extraction of inadvertently placed left ventricular and left atrial endocardial pacemaker leads with flow-preserving complete cerebral embolic protection. We also review the current literature regarding the incidence, management, and percutaneous extraction of left-sided cardiac leads.

Fifteen-year experience with carotid artery stenting (from the carotid artery stenting-registry of the Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte).

To date only sparse data are available on trends and changes in indications, patient's characteristics, and clinical outcome of patients undergoing carotid artery stenting (CAS) in clinical practice. From February 1996 to December 2010, 6,116 CAS procedures were performed in 5,976 patients at 36 hospitals within the prospective, multicenter CAS registry of the Arbeitsgemeinschaft Leitende Kardiologische Krankenhausärzte. Median age of patients was 71 years, 71.6% were men; a symptomatic stenosis was treated in 50.3% and an embolic protection device (EPD) was used in 82.5% of the patients. The overall hospital mortality or stroke rate was 3.1%. Stroke or in-hospital death occurred in 4.0% in symptomatic patients and in 2.2% in asymptomatic patients. In a logistic regression model, independent predictors of in-hospital death or stroke were heart failure (odds ratio [OR] 2.03, 95% confidence interval [CI] 1.22 to 3.36, p = 0.006), symptomatic stenosis (OR 1.52, 95% CI 1.05 to 2.18, p = 0.03), and age (OR per 10 years 1.46, 95% CI 1.17 to 1.81, p <0.001). The use of an EPD was significantly associated with a lower rate of death or stroke in the registry (OR 0.45, 95% CI 0.26 to 0.78, p = 0.004). From 1996 to 2010, mean age of patients increased by 4.1 years (p <0.001), the proportion of male patients decreased from 82.4% to 70.2% (p = 0.07), the proportion of symptomatic stenoses decreased (84.6% to 24.7%, p <0.001), and the use of EPDs increased from 1.4% to 97.2% (p <0.001). Comparing 2 periods from 1996 to 2003 and 2004 to 2010, a numeric decrease in the in-hospital stroke or death rate was seen in symptomatic (4.7% vs 3.5%, p = 0.11), and in asymptomatic patients (2.9% vs 2.1%, p = 0.27) undergoing CAS, which did not reach statistical significance. In conclusion, the proportion of symptomatic carotid artery stenoses decreased significantly; EPDs established as a standard tool and a numeric decrease of in-hospital stroke or death was seen in asymptomatic and symptomatic patients undergoing CAS in clinical practice over the last 15 years.

US nationwide trends in carotid revascularization: is there a clinical opportunity cost associated with the introduction of novel medical devices?

OBJECTIVES: Nationwide practice patterns during the implementation of novel technology, such as carotid angioplasty and stenting (CAS) and embolic protection devices (EPD), and the clinical impact thereof have received less attention. METHODS: The Nationwide Inpatient Sample, constituting a 20% representative sample of non-federal US hospitals, was analyzed from years 1998 to 2007. Hospital outcome was stratified into in-hospital mortality (IHM), long-term facility discharge, and home/ short-term facility discharge (HSF). RESULTS: Discharge outcome improved for CAS over the decade. However, this improvement occurred in two phases with a period of worsening (2003-2005) in between. During this transition period, the risk of IHM following CAS was increased (RR 1.29-2.43) and was lower for good outcome (HSF: RR 0.97-0.99) when compared with 2002/2003. During the same transition period, carotid endarterectomy (CEA) was associated with a lower risk of IHM (RR 0.75-1.00), but also a lower risk of HSF (RR 0.98-0.99). CONCLUSIONS: The results lead to the hypothesis that the nationwide introduction of CAS-EPD may have been associated with temporary increases in in-hospital mortality and discharge morbidity. If such 'clinical opportunity costs' exist with the widespread introduction and adoption of new medical technology with proven efficacy in randomized trials, effective mechanisms are needed for mitigation or prevention during the transition period.

Comparison of the reperfusion efficacy of thrombus aspiration with and without distal protection during primary percutaneous coronary intervention in patients with acute ST-segment elevation myocardial infarction.

We evaluated a hypothesis that thrombus aspiration with distal protection is superior to simple thrombus aspiration in patients treated with primary percutaneous coronary intervention (PCI). A total of 176 consecutive patients with ST-segment elevation myocardial infarction were enrolled in this study and assigned to either the thrombus aspiration group (A, n = 104) or the thrombus aspiration with distal protection group using a filter device system (A + DP, n = 72). We compared the angiographic reperfusion grade, left ventricular (LV) function, and clinical outcomes between the 2 groups. There were no significant differences in age, gender distribution, the onset-to-reperfusion time, the peak levels of creatine kinase, or 6-month mortality between the 2 groups. The rate of achieving a Thrombolysis In Myocardial Infarction flow grade of 3 and a myocardial blush grade of 3 was higher in the A + DP group than in the A group. Among the patients who underwent follow-up catheterization 6 months after PCI (A, n = 62; A + DP, n = 52), there were no significant differences in the LV end-diastolic volume index, LV end-systolic volume index, or LV ejection fraction between the 2 groups at the time of PCI or 6 months after PCI. In conclusion, thrombus aspiration with distal protection may be more effective in initially restoring the coronary blood flow than thrombus aspiration alone, although it may not be superior to thrombus aspiration in preventing LV remodeling or preserving the LV function in patients with ST-segment elevation myocardial infarction.

Left atrial appendage closure devices. Their role in 2013.

Stroke prevention is the major goal in treating patients with atrial fibrillation. Warfarin therapy, if used appropriately, is highly effective in preventing thromboembolic events, but is simultaneously burdened by a narrow therapeutic window, multiple food and drug interactions, and a substantial bleeding risk. New pharmacological agents show only a modest reduction of bleeding complications compared to warfarin. Percutaneous device left atrial appendage (LAA) closure has now been technologically advanced as an additional and potential alternative to pharmacotherapy in patients with AF. Promising randomized data are obtainable with the WATCHMAN® device, while several other devices are in various stages of clinical and preclinical development. In this article we review the current knowledge and status of this technique.

Acute and long-term results of carotid stenting under proximal embolic protection using the Gore Flow Reversal System.

OBJECTIVE: This study evaluates short- and long-term results of CAS with the Gore Flow Reversal System (GFRS). BACKGROUND: Embolic protection devices are of fundamental importance in carotid artery stenting (CAS). Proximal protection has potential advantages compared with distal protection. Limited data are available regarding the safety of the proximal GFRS. METHODS: CAS was performed with the GFRS. Patients' neurological status was assessed during the intervention and at follow-up. Results of patients treated before 2006 were also compared to those of patients treated after 2006 because of changes in device design. RESULTS: CAS was performed in 86 patients with 87 stenoses (symptomatic in 37%). The procedure was technically successful in all cases. In 11 patients a transient periprocedural neurologic deficit occurred related to temporary cerebral flow compromise during balloon occlusion with complete resolution at completion of the procedure. The stroke/death rate at one month was 2.3% with a combined ipsilateral stroke and death rate at one year of 4.6%. There was no significant difference in event rates between the newer and older device version. Overall follow-up time was 484 ± 3.4 patient years with a range of 0 to 119 months. The average yearly ipsilateral stroke rate including the first 30 days was 0.96%. CONCLUSION: Our results demonstrate that CAS using the GFRS is safe whether the original or new device versions were used. The periprocedural stroke rate is at least as low as the stroke rate reported using distal protection. The long-term stroke rate after CAS is low.

Carotid artery stenting in patients with symptomatic carotid stenosis: a single-center series.

OBJECTIVES: Carotid angioplasty with stenting (CAS) in patients with carotid stenosis (CS) has become more restricted in France especially since the disclosure of such studies as EVA-3S and Stent-supported percutaneous angioplasty of the carotid artery versus endarterectomy (SPACE). This report is of a series of CS cases contraindicated for endarterectomy that underwent CAS at a French center of interventional neuroradiology. PATIENTS AND METHODS: Fifty-five patients with symptomatic CS more than 60% consecutively submitted to CAS between September 2008 and February 2011. The primary endpoint was either death or stroke within 30 days of the procedure; a secondary goal was to identify any possible factors that might have influenced the success and outcome of the intervention. RESULTS: The overall periprocedural stroke/death rate at 30 days was 5.4% (three out of 55 patients), with three non-disabling strokes and no deaths. Twenty-seven patients (49.1%) were treated with a cerebral protection device (CPD). Stent placement was achieved in all cases. Open- and closed-cell stents were implanted in 40 (72.7%) and 15 procedures (27.3%), respectively. Neither the use of a CPD, the carotid stent cell design nor any anatomical or technical factors were associated with a lower risk of stroke or death within 30 days of CAS. CONCLUSION: CAS in symptomatic patients with CS contraindicated for endarterectomy in this selected French series proved feasible and safe, with acceptable levels of morbidity. Use of a CPD, type of stent (open- or closed-cell), and anatomical and technical factors had no influence on the success of the procedure or the outcome within 30 days of the operation.

Distal protection devices in primary percutaneous coronary intervention of native coronary artery lesions: a meta-analysis of randomized controlled trials.

OBJECTIVE: The use of embolic protection devices to decrease major adverse cardiac events (MACEs) in patients with saphenous vein graft lesions is considered class I therapy by the recent practice guidelines. However, the benefits of adjunctive protection devices to prevent distal embolization in patients with native coronary artery lesions are still a matter of debate. Therefore, we performed the meta-analysis to determine whether the use of distal protection devices during revascularization can improve myocardial perfusion and reduce the occurrence of MACEs compared with primary percutaneous coronary intervention (PCI) alone. METHODS AND RESULTS: Studies were identified in English-language articles by search of Medline and Embase database (inception to December 2011). A total of 15 prospective randomized controlled trials involving 2783 patients were included for analysis (1378 patients in the distal protection device group and 1405 cases in the control group). Overall, adjunctive embolic protection was associated with significantly improved postprocedural TIMI 3 (thrombolysis in myocardial infarction 3) flow (OR 1.71; 95% CI 1.13-2.57; P = 0.01) and MBG 3 (myocardial blush grade 3) (OR 1.50; 95% CI 1.09-2.07; P = 0.01), whereas the overall MACEs analysis demonstrated that a nonsignificant trend was observed toward better clinical outcomes associated with adjunctive protection devices at 1 month (OR 0.80; 95% CI 0.55-1.15; P = 0.23) and at 6 months (OR 0.80; 95% CI 0.55-1.17; P = 0.24). When stratified by MACEs, no statistical differences were found among mortality, reinfarction, and target vessel revascularization (TVR), respectively. CONCLUSIONS: The meta-analysis indicated an improvement of myocardial perfusion in AMI patients treated with adjunctive protection devices. However, a nonsignificant trend was observed toward a lower risk of MACEs in the distal protection device group when compared with the control group.

When is embolic protection needed in lower extremity interventions and how should it be done.

Distal embolization (DE) during lower extremity arterial intervention is a potentially devastating complication which could lead to limb loss. The use of a distal embolic protection device (EP) may prevent significant DE during intervention. Studies investigating the incidence and impact of DE suggest that it is a rare event with low impact on clinical outcomes. The use of EP during peripheral interventions has only been studied in uncontrolled small series with no comparison to unprotected interventions. In spite of the absence of good quality studies, there may be situations where EP is helpful. These situations may be when lesions or devices are particularly prone to produce emboli. The EP device may produce its own serious complications which must be considered prior to their use. In addition these devices are fairly expensive, a factor that needs to be considered when deciding to employ EP. A simple direct comparison of EP vs. no EP during lower extremity intervention could answer many clinical questions surrounding this controversy.

Results of carotid artery stenting with distal embolic protection with improved systems: Protected Carotid Artery Stenting in Patients at High Risk for Carotid Endarterectomy (PROTECT) trial.

OBJECTIVE: The Protected Carotid Artery Stenting in Patients at High Risk for Carotid Endarterectomy (PROTECT) study was performed to evaluate the safety and effectiveness of two devices for carotid artery stenting (CAS) in the treatment of carotid artery stenosis in patients at high risk for carotid endarterectomy (CEA): (1) a new embolic protection device, the Emboshield Pro (Abbott Vascular, Abbott Park, Ill), using the periprocedural composite end point of 30-day death, stroke, and myocardial infarction (DSMI), and (2) a carotid stent in conjunction with an embolic protection device (EPD) using the DSMI periprocedural composite end point plus ipsilateral stroke at up to 3 years for long-term evaluation. METHODS: This prospective, multicenter clinical trial enrolled 220 consecutive participants between November 29, 2006, and January 14, 2008, followed by a second cohort of 102 participants between January 14 and June 18, 2008. Enrolled participants had carotid stenosis (symptomatic >50% or asymptomatic >80%). The first 220 subjects underwent distal EPD placement with a new large-diameter filter, and the second cohort of 102 underwent placement of an older EPD that is no longer manufactured. All 322 participants were to be treated with a dedicated carotid stent with a tapered, small, closed-cell design (Xact; Abbott Vascular) and were to be included in the long-term evaluation. Independent neurologic assessment was performed before CAS and at 1 day, 30 days, and annually after CAS. All primary end point events were independently adjudicated by a central committee. RESULTS: The periprocedural composite end point of DSMI (95% confidence interval) in the first 220 participants was 2.3% (0.74%, 5.22%), with a combined death and stroke rate of 1.8% (0.50%, 4.59%) and a rate of death and major stroke of 0.5% (0.01%, 2.51%). As of January 3, 2011, the median follow-up for the entire 322-subject cohort for the long-term evaluation was 2.8 years. Freedom from the periprocedural composite of DSMI plus ipsilateral stroke thereafter was 95.4%, with an annualized ipsilateral stroke rate of 0.4%. CONCLUSIONS: CAS outcomes in patients at high risk for CEA have improved from earlier carotid stent trials. With periprocedural rates of DSMI of 2.3%, death or stroke at 1.8%, and death or major stroke rate of 0.5%, PROTECT has the lowest rate of periprocedural complications among other comparable single-arm CAS trials in patients at high risk for CEA.

Embolic protection device use and outcomes in patients receiving saphenous vein graft interventions--a single-center experience.

BACKGROUND: Percutaneous treatment of saphenous vein graft disease is hampered by high rates of periprocedural myocardial infarction (MI). The use of embolic protection devices (EPD) during these interventions is a class IB recommendation when technically feasible, yet they are used routinely in less than half of all cases. Our aim was to explore whether or not the under-utilization of EPDs led to any untoward cardiovascular events. METHODS: Consecutive vein graft interventions from 2003-2008 were identified and stratified by EPD use. Information pertaining to demographics, comorbidities, medication use, and procedural details was collected. Primary endpoint was to compare the incidence of periprocedural MI, defined as any creatinine kinase-MB fraction elevation greater than 3 times the upper limit of normal between patients who underwent percutaneous coronary intervention (PCI) for saphenous vein grafts (SVG) with EPD versus patients who underwent PCI for SVG without EPD. Secondary endpoints included comparison of the incidence of recurrent ischemia, MI, revascularization (PCI or coronary artery bypass graft [CABG]), and mortality in the above 2 groups by the end of 1 year. RESULTS: A total of 164 consecutive vein graft interventions were identified. EPDs were used in 71 cases (43.4%). The EPD group was further out since their CABG and had a higher prevalence of hypertension and diabetes. Periprocedural MI occurred in 22 cases; 12 in the non-EPD group and 10 in the EPD group (14.1 vs. 12.9%; P=.82). The composite endpoint of death, MI, or target vessel revascularization at 12 months was significantly lower when EPDs were used (11.3 vs. 25.8%; P=.03). On multivariate analysis, chronic kidney disease increased the risk of periprocedural MI (odds ratio [OR], 5.36; 95% confidence interval [CI], 1.90-15.13; P=.002), whereas the use of beta-blockers was protective (OR, 0.22; 95% CI, 0.07-0.70; P=.011). CONCLUSIONS: EPD use during vein graft interventions did not improve periprocedural MI rates. However, the composite endpoint of adverse cardiovascular outcomes at 1 year was significantly reduced. EPDs are used in a minority of vein graft interventions. Efforts aimed at improving adherence to EPD use may improve long-term outcomes, though this hypothesis should be tested using prospective, randomized studies.