Flow arrest during carotid artery stenting with a distal embolic protection device: A single-center experience and clinical implications.

Objective: We aimed to investigate the incidence of flow arrest during carotid artery stenting (CAS) with filter-type embolic protection device (EPD), identify any predisposing factors for those situations, and contemplate intraprocedural precautionary steps. Methods: CAS was performed in 128 patients with 132 arteries using filter-type EPD. The characteristics of treated patients and arteries were compared between groups with and without flow arrest. Results: The incidence of flow arrest during CAS with filter-type EPD was 17.4%. In flow arrest group, cases of vulnerable plaques (p=0.02) and symptomatic lesions (p=0.01) were significantly more common, and there were more cases of debris captured by EPD in a planar pattern (p<0.01). Vulnerable plaques were significantly more common in the procedures showing a planar pattern than in the cases with other patterns (p<0.01). Flow arrest group showed a significantly higher rate of ischemic complications (p<0.05), although there were no significant periprocedural neurological changes. The planar pattern of captured debris in filter-type EPD was the only significant risk factor for flow arrest (adjusted odds ratio 88.44, 95% confidence interval 15.21-514.45, p<0.05). Conclusions: Flow arrest during CAS with filter-type EPD is not uncommon and associated with increased ischemic complications. Symptomatic stenoses and vulnerable plaque are related to this event. The planar pattern of captured debris on the EPD was the only significant risk factor for the flow arrest. Clinicians must pay attention to the occurrence of flow arrest and react quickly when performing CAS.

Role of Cerebral Embolic Protection Devices in Patients Undergoing Transcatheter Aortic Valve Replacement: An Updated Meta-Analysis.

BACKGROUND: Cerebral embolic protection devices (CEPD) capture embolic material in an attempt to reduce ischemic brain injury during transcatheter aortic valve replacement. Prior reports have indicated mixed results regarding the benefits of these devices. With new data emerging, we performed an updated meta-analysis examining the effect of CEPD during transcatheter aortic valve replacement on various clinical, neurological, and safety parameters. METHODS AND RESULTS: A comprehensive review of electronic databases was performed comparing CEPD and no-CEPD in transcatheter aortic valve replacement. Primary clinical outcome was all-cause stroke. Secondary clinical outcomes were disabling stroke and all-cause mortality. Neurological outcomes included worsening of the National Institutes of Health Stroke Scale score, Montreal Cognitive Assessment score from baseline at discharge, presence of new ischemic lesions, and total lesion volume on neuroimaging. Safety outcomes included major or minor vascular complications and stage 2 or 3 acute kidney injury. Seven randomized controlled trials with 4016 patients met the inclusion criteria. There was no statistically significant difference in the primary clinical outcome of all-cause stroke; secondary clinical outcomes of disabling stroke, all-cause mortality, neurological outcomes of National Institutes of Health Stroke Scale score worsening, Montreal Cognitive Assessment worsening, presence of new ischemic lesions, or total lesion volume on diffusion-weighted magnetic resonance imaging between CEPD versus control groups. There was no statistically significant difference in major or minor vascular complications or stage 2 or 3 acute kidney injury between the groups. CONCLUSIONS: The use of CEPD in transcatheter aortic valve replacement was not associated with a statistically significant reduction in the risk of clinical, neurological, and safety outcomes.

Fabrication of a monorail-type diagnostic catheter for rescue retrieval technique of a distal embolic protection device.

In this technical report, we describe a challenging case concerning the retrieval of a distal embolic protection device (DEPD) post-carotid artery stenting. We propose a novel rescue retrieval technique for DEPD, employing a fabricated monorail-type HN5 diagnostic catheter. When integrated with existing strategies, this approach may optimize and streamline the process of DEPD removal.

Cerebral embolic protection during transcatheter stent expansion of restrictive extra-cardiac Fontan conduit.

We report a 20-year-old female patient (76 Kg/164 cm) with an extra-cardiac Fontan circulation who was referred to our institution for exertional dyspnoea and desaturation. The patient was diagnosed with a large calcified thrombus at the level of the Fontan fenestration, protruding inside the lumen of the conduit and reducing the diameter by half with a 3 mmHg pressure gradient. Transcatheter stent expansion of the obstructed extra-cardiac conduit was done with a 48 mm long XXL PTFE-covered Optimus-CVS® under temporary cerebral embolic protection with a TriGUARD-3™ deflection filter device (Keystone Heart). There was no procedural complication and the 3 months clinical outcomes are good.

Cerebral Embolic Protection Devices During Transcatheter Aortic Valve Replacement: A Meta-analysis of Randomized Controlled Trials.

Background: Stroke is a feared complication of transcatheter aortic valve replacement (TAVR), which embolic protection devices (EPDs) may mitigate. This systematic review and meta-analysis synthesized randomized controlled trials (RCTs) to evaluate the effect of EPDs in TAVR. Methods: All RCTs comparing EPDs with control during TAVR were systematically identified. Prespecified primary end points were all stroke, disabling stroke, nondisabling stroke, and all-cause mortality. Safety and neuroimaging parameters were assessed. Sensitivity analyses were stratified by EPD type. Study registration was a priori (CRD42022377939). Results: Eight trials randomizing 4043 patients were included. There was no significant difference between EPDs and control for all stroke (relative risk [RR], 0.88; 95% CI, 0.65-1.18; P = .39; I2 = 0%), disabling stroke (RR, 0.67; 95% CI, 0.31-1.46; P = .32; I2 = 8.6%), nondisabling stroke (RR, 0.99; 95% CI, 0.71-1.40; P = .97; I2 = 0%), or all-cause mortality (RR, 0.87; 95% CI, 0.43-1.78; P = .71; I2 = 2.3%). There were no differences in safety end points of bleeding, vascular complications, or acute kidney injury. EPDs did not result in differences in total lesion volume or the number of new lesions. The Sentinel EPD significantly reduced the risk of disabling stroke (RR, 0.42; 95% CI, 0.20-0.88; P = .022; I2 = 0%) but did not affect all stroke, nondisabling stroke, or all-cause mortality. Conclusions: The totality of randomized data for EPDs during TAVR demonstrated no safety concerns or significant differences in clinical or neuroimaging end points. Analyses restricted to the Sentinel EPD demonstrated large, clinically meaningful reductions in disabling stroke. Ongoing RCTs may help validate these results.

Safety and efficacy of cerebral embolic protection devices for patients undergoing transcatheter aortic valve replacement: An updated meta-analysis.

Background and Aims: Cerebral embolic protection (CEP) devices are employed to capture embolic debris and reduce the risk of stroke during transcatheter aortic valve replacement (TAVR). Evidence is mixed regarding the safety and efficacy of CEP. We aimed to summarize the safety and effectiveness of CEP use during TAVR. Methods: Electronic databases, including PubMed, PubMed Central, Scopus, Cochrane Library, and Embase, were searched using relevant search terms for articles relating to CEP. All relevant data from 20 studies were extracted into a standardized form. Statistical analyses were performed using Revman 5.4. Odds ratio (OR) or mean differences (MDs) were used to estimate the desired outcome with a 95% confidence interval (CI). Results: Twenty studies (eight randomized controlled trials [RCTs]) involving 210,871 patients (19,261 in the CEP group and 191,610 in TAVR without the CEP group) were included. The use of CEP was associated with a lower odds of 30-day mortality by 39% (OR: 0.61, 95% CI: 0.53-0.70) and stroke by 31% (OR: 0.69, 95% CI: 0.52-0.92). Comparing devices, benefit in terms of mortality and stroke was observed with the use of the Sentinel device (Boston Scientific), but not among other devices. No differences were observed in the outcomes of acute kidney injury, major or life-threatening bleeding events, or major vascular complications between groups. When only RCTs were included, there were no observed differences in the primary or secondary outcomes for CEP versus no CEP use during TAVR. Conclusions: The totality of evidence suggests a net benefit for the use of CEP, weighted by studies in which the Sentinal device was used. However, given the RCT subanalysis, additional evidence is needed to identify patients at the highest risk of stroke for optimal decision-making.

The relationship between ultrasonographic plaque morphology and histopathology of embolic material captured in the protective filter during carotid artery stenting.

PURPOSE: We aimed to correlate the presence or absence of embolic debris in filter-type embolic protection devices (EPD), which are frequently used during carotid artery stenting (CAS), with possible risk factors and ultrasonographic plaque features. MATERIALS AND METHODS: Eighty patients, who underwent CAS using a filter-type EPD in the period between July 2016 and March 2019, were included in our study. The modified Gray-Weale classification (mGWC) subtypes obtained in the pre-procedural ultrasonographic examinations were recorded. In addition, other patient-related risk factors considered to be related to a distal embolism were recorded. After the procedure the filters were evaluated to detect and examine embolic debris in the pathology clinic. The presence and features of embolic debris in the filters were recorded. RESULTS: In the examinations performed after CAS, embolic debris was macroscopically and microscopically detected in 22 (27%) and 34 (42.5%) of the filter-type EPDs, respectively. A significant correlation was found between the change in the mGWC category of stenotic plaques from type 5 to type 1 and the presence of embolic debris in the filter (p < 0.05). Furthermore, a significant relationship was found between stenotic segment length and the presence of embolic debris in the filter (p < 0.05). The presence of embolic debris was not statistically significantly related to predisposing risk factors for atherosclerosis (p > 0.05). CONCLUSIONS: During CAS, the likelihood of the presence of embolic debris in the EPDs increases as mGWC categories change from type 5 to type 1 and as the length of the stenotic segment increases.

Proximal balloon-guided catheter with flow inversion vs. distal filter protection during the carotid stent placement, a seven years experience in a Colombian reference center.

BACKGROUND AND PURPOSE: The carotid stent placement as a therapeutic option for carotid stenosis has been increasing among years; therefore, studies are required to evaluate the security and efficacy of its materials. The purpose of this study was to evaluate the distal filter and the proximal balloon-guided catheter with flow inversion as protection devices during carotid angioplasty and stenting. METHODS: This is a retrospective, observational study of patients diagnosed with carotid stenosis treated with angioplasty between January 1, 2014, and June 30, 2020; we analyzed a radiology service database to compare the distal filter and the proximal balloon-guided catheter as protection devices during angioplasty. RESULTS: One hundred seventy-five angioplasties were performed, the distal filter was the most prevalent embolic protection device used (66%), patients baseline characteristics did not differ between groups with different embolic protection devices, except for history of dyslipidemia (p < 0.000). As well, we did not find any significant differences between the groups in the device related complications, intervention time (p = 0.140), unrelated complications (p = 0.693) and functional independence at 90 days (p = 0.096). CONCLUSIONS: In our study the proximal balloon-guided catheter and the distal filter protection device as protection devices during the carotid stenting didn't show significant differences regarding complications related to the system.

Stroke prevention during and after transcatheter aortic valve implantation: From cerebral protection devices to antithrombotic management.

Since its conception, transcatheter aortic valve implantation (TAVI) has undergone important improvements both in the implantation technique and in transcatheter devices, allowing an enthusiastic adoption of this therapeutic approach in a wide population of patients previously without a surgical option and managed conservatively. Nowadays, patients with severe symptomatic aortic stenosis are typically managed with TAVI, regardless of their risk to surgery, improving the prognosis of patients and thus achieving an exponential global expansion of its use. However, thromboembolic and hemorrhagic complications remain a latent concern in TAVI recipients. Both complications can appear simultaneously in the periprocedural period or during the follow-up, and when minor, they resolved without apparent sequelae, but in a relevant percentage of cases, they are devastating, overshadowing the benefit achieved with TAVI. Our review outlines the etiology and incidence of thromboembolic complications associated with TAVI, the main current strategies for their prevention, and the implications of its pharmacological management at the follow-up in a TAVI population, mostly frail and predisposed to bleeding complications.

Cerebral embolic protection and severity of stroke following transcatheter aortic valve replacement.

BACKGROUND: The cerebral embolic protection (CEP) device captures embolic debris during transcatheter aortic valve replacement (TAVR). However, the impact of CEP on stroke severity following TAVR remains unclear. Therefore, we aimed to examine whether CEP was associated with reduced severity of stroke following TAVR. METHODS: This was a retrospective cohort study of 2839 consecutive patients (mean age: 79.2 ± 9.5 years, females: 41.5%) who underwent transfemoral TAVR at our institution between 2013 and 2020. We categorized patients into Sentinel CEP users and nonusers. Neuroimaging data were reviewed and the final diagnosis of a cerebrovascular event was adjudicated by a neurologist blinded to the CEP use or nonuse. We compared the incidence and severity (assessed by the National Institutes of Health Stroke Scale [NIHSS]) of stroke through 72 h post-TAVR or discharge between the two groups using stabilized inverse probability of treatment weighting (IPTW) of propensity scores. RESULTS: Of the eligible patients, 1802 (63.5%) received CEP during TAVR and 1037 (36.5%) did not. After adjustment for patient characteristics by stabilized IPTW, the rate of overall stroke was numerically lower in CEP users than in CEP nonusers, but the difference did not reach statistical significance (0.49% vs. 1.18%, p = 0.064). However, CEP users had significantly lower rates of moderate-or-severe stroke (NIHSS ≥ 6: 0.11% vs. 0.69%, p = 0.013) and severe stroke (NIHSS ≥ 15: 0% vs. 0.29%, p = 0.046). Stroke following CEP use (n = 8), compared with stroke following CEP nonuse (n = 15), tended to carry a lower NIHSS (median [IQR], 4.0 [2.0-7.0] vs. 7.0 [4.5-19.0], p = 0.087). Four (26.7%) out of 15 patients with stroke following CEP nonuse died within 30 days, with no death after stroke following CEP use. CONCLUSIONS: CEP use may be associated with attenuated severity of stroke despite no significant difference in overall stroke incidence compared with CEP nonuse. This finding is considered hypothesis-generating and needs to be confirmed in large prospective studies.

Hybrid approach for cerebral protection in open-heart surgery: Case series.

BACKGROUND: Stroke remains one of the most important complications of cardiac surgery and occurs in 2.2% after open-heart procedure. It is associated with significant morbidity and mortality. The use of a cerebral protection system during transcatheter aortic valve implantation may be associated with a lower risk of periprocedural strokes, and mortality at 30 days. The aim of the present study was to assess the safety and feasibility of this device in patients at high risk for stroke during open cardiac surgery. METHODS: We present six patients with a high risk of perioperative stroke who underwent placement of Sentinel cerebral protection system during various open-heart operations between 2018 and 2021. RESULTS: The system was successfully deployed, and debris was retrieved in all patients. There was no device-related complication or development of ischemic stroke postoperatively. One patient suffered from intracranial hemorrhage due to peri-operative coagulopathy. CONCLUSIONS: We demonstrated the feasibility and safety of this hybrid approach with a high debris capture rate. It encourages further study to evaluate the benefits of the Sentinel cerebral protection system in reducing stroke and mortality in selected patients undergoing open-heart surgery.

Overview of FDA Circulatory System Devices Panel virtual meeting on TriGUARD 3 cerebral embolic protection.

Despite advances in transcatheter aortic valve replacement (TAVR) technology, periprocedural stroke remains a complication of TAVR procedures. The TriGUARD 3 device is designed to be positioned in the aortic arch to deflect debris away from the brachiocephalic, left common carotid, and left subclavian arteries during TAVR. The United States Food and Drug Administration (FDA) assembled the Circulatory System Devices Panel to review safety and effectiveness data for the TriGUARD 3 device. Because of the coronavirus disease 2019 pandemic, this meeting was held virtually. In this manuscript, we summarize the data presented by both the sponsor and FDA, as well as the panel discussion.

Complications and failure modes of coronary embolic protection devices: Insights from the MAUDE database.

BACKGROUND: There is limited data on complications associated with the use of coronary embolic protection devices (EPDs). METHODS: We queried the Manufacturer and User Facility Device Experience database between November 2010 and November 2020 for reports on coronary EPDs: Spider FX (Medtronic, Minneapolis, MN) and Filterwire EZ (Boston Scientific, Natick, MA). RESULTS: We retrieved 119 reports on coronary EPD failure (Spider FX n = 33 and Filterwire EZ n = 86), most of which (78.2%) occurred during saphenous vein graft interventions. The most common failure mode was inability to retrieve the EPD (49.6%), with the filter trapped against stent struts in 76.2% of the cases. Other device complications included filter fracture (28.6%), failure to cross (7.6%), failure to deploy (7.6%), and failure to recapture the filter (3.4%). Filter fracture (54.5 vs. 29.1%) and failure to recapture (9.1 vs. 2.1%) were more commonly reported, while failure to deploy the filter (0 vs. 10.5%) was less commonly reported with the Spider-FX. CONCLUSIONS: The most common modes of failure of coronary EPDs are the failure of retrieval (49.6%), followed by the filter fracture (28.6%). When using EPDs, careful attention to the technique is essential to avoid failures and subsequent complications.

"Tailor-made" Total Cerebral Protection during Transcatheter Aortic Valve Implantation.

Transcatheter aortic valve implantation (TAVI) is an alternative treatment to surgical aortic valve replacement for treating severe aortic stenosis. With the increased use of TAVI, the risk of cerebrovascular complications during the procedure has become an emerging problem. We evaluated the safety and feasibility of our total cerebral protection methods using embolic protection devices (EPDs) for carotid artery stenting. We collected the results of cases in which the clinical team determined that our protection method was necessary among patients undergoing TAVI from May to October 2019 in our medical center. We applied this method to patients who had a potentially high risk of cerebrovascular events during the procedure. The methods of protection were selected comprehensively based on the potential of collateralization of brain perfusion when some arteries were blocked with a balloon, accessibility of the brain arteries, and the ability to cover the brain arteries with devices. Five patients, aged 83.8 ± 1.8 years, were included in the study. Technical success was achieved in all five patients. No cases showed any new neurological symptoms after the procedures; however, head MRI on the day after showed new ischemic lesions in three of five cases (60%). In all cases, emboli were found in the collected filters. This report demonstrates protection of the entire perfusion area in each case using EPDs in patients at high risk of intraoperative embolism. The methods we used were feasible and can potentially reduce cerebrovascular events following TAVI.

Saphenous Vein Graft Failure: From Pathophysiology to Prevention and Treatment Strategies.

Saphenous vein grafts (SVGs) remain the most frequently used conduits in coronary artery bypass graft surgery (CABG). Despite advances in surgical techniques and pharmacotherapy, SVG failure rates remain high, often leading to repeat coronary revascularization. The no-touch SVG harvesting technique (minimal graft manipulation with preservation of vasa vasorum and nerves) reduces the risk of SVG failure, whereas the effect of the off-pump technique on SVG patency remains unclear. Use of buffered storage solutions, intraoperative graft flow measurement, careful selection of the target vessels, and physiological assessment of the native coronary circulation before CABG may also reduce the incidence of SVG failure. Perioperative aspirin and high-intensity statin administration are the cornerstones of secondary prevention after CABG. Dual antiplatelet therapy is recommended for off-pump CABG and in patients with a recent acute coronary syndrome. Intermediate (30%-60%) SVG stenoses often progress rapidly. Stenting of intermediate SVG stenoses failed to improve outcomes; hence, treatment focuses on strict control of coronary artery disease risk factors. Redo CABG is associated with higher perioperative mortality compared with percutaneous coronary intervention (PCI); hence, the latter is preferred for most patients requiring repeat revascularization after CABG. SVG PCI is limited by high rates of no-reflow and a high incidence of restenosis during follow-up. Drug-eluting and bare metal stents provide similar long-term outcomes in SVG PCI. Embolic protection devices reduce no-reflow and should be used when feasible. PCI of the corresponding native coronary artery is associated with better short- and long-term outcomes and is preferred over SVG PCI, if technically feasible.

Use and outcomes of cerebral embolic protection for transcatheter aortic valve replacement: A US nationwide study.

BACKGROUND: Outcomes data on the use of cerebral embolic protection devices (CPDs) with transcatheter aortic valve replacement (TAVR) remain limited. Previous randomized trials were underpowered for primary outcomes of stroke prevention and mortality. METHODS: The National Inpatient Sample and Nationwide Readmissions Database were queried from 2017 to 2018 to study utilization and inpatient mortality, neurological complications (ischemic stroke, hemorrhagic stroke, and transient ischemic attack), procedural complications, resource utilization, and 30-day readmissions with and without use of CPD. A 1:3 ratio propensity score matched model was created. RESULTS: Among 108,315 weighted encounters, CPD was used in 4380 patients (4.0%). Adjusted mortality was lower in patients undergoing TAVR with CPD (1.3% vs. 0.5%, p < 0.01). Neurological complications (2.5% vs. 1.7%, p < 0.01), hemorrhagic stroke (0.2% vs. 0%, p < 0.01) and ischemic stroke (2.2% vs. 1.4%, p < 0.01) were also lower in TAVR with CPD. Multiple logistic regression showed CPD use was associated with lower adjusted mortality (odds ratio (OR], 0.34 [95% confidence interval [CI], 0.22-0.52), p < 0.01) and lower adjusted neurological complications (OR, 0.68 (95% CI, 0.54-0.85], p < 0.01). On adjusted analysis, 30-day all-cause readmissions (Hazard ratio, HR 0.839, [95% CI, 0.773-0.911], p < 0.01) and stroke (HR, 0.727 [95% CI, 0.554-0.955), p = 0.02) were less likely in TAVR with CPD. CONCLUSION: We report real-world data on utilization and in-hospital outcomes of CPD use in TAVR. CPD use is associated with lower inpatient mortality, neurological, and clinical complications as compared to TAVR without CPD.

Tailored approaches for transcatheter closure of postsurgical pseudoaneurysms from the ascending aorta and brachiocephalic artery.

Ascending aortic pseudoaneurysms following open-heart surgery are treated by redo surgery or endovascular therapy when surgical risks are high. Extreme variations in their morphology, proximity to coronary and arch branches and vascular access may vary the timing, strategy, device choice, and technique in each patient. Three patients with varying etiology, presentations, and morphology of the pseudoaneurysms underwent successful endovascular exclusion by individually tailored strategies. The approach includes optimal treatment of the underlying infections before the endovascular intervention despite the emergency to treat the condition; choosing appropriate device depending on the proximity to aortic branches, choosing appropriate access depending on the angulation of the entry of pseudoaneurysm to the aortic lumen, and use of adequate imaging for achieving procedural success. .

Management of Mobile Thrombus With Distal Protection Devices During Carotid Artery Angioplasty: 2-Dimensional Operative Video.

Embolic protection devices (EPDs) have become a standard of care during internal carotid artery revascularization.1,2 This video is about a 57-yr-old-male who presented with a wake-up stroke with a left hemispheric syndrome. Head computed tomography angiography (CTA) revealed tandem occlusions of the proximal left internal carotid artery (ICA) and of the distal left middle cerebral artery (MCA) with an ASPECT (Alberta Stroke Program Early CT Score) score of 6. The patient underwent a cerebral angiogram and was treated with balloon angioplasty with a distal EPD and mechanical thrombectomy. The EPD became occluded with thrombus from the ICA and was retrieved through a 6-Fr Sofia (MicroVention) under continuous aspiration. Successful revascularization of the proximal ICA and distal MCA was achieved. No procedure-related complications occurred, and the patient's neurological exam improved. Tandem occlusions can occur in up to 15% of strokes. The optimal treatment can be controversial, but mechanical thrombectomy and ICA revascularization with a distal EPD appear to be safe and effective in selected patients.3 Consent was obtained for the procedure and for the video production.

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.