Sentinel Cerebral Protection System Research Articles

Cerebral Embolic Protection in Transcatheter Aortic Valve Implantation Using the Sentinel Cerebral Protection System: A Systematic Review and Meta-Analysis.

Transcatheter aortic valve implantation (TAVI) plays a vital role in patients with symptomatic aortic stenosis. Despite the mortality benefit of TAVI, embolic stroke remains a feared complication. As a result, transcatheter cerebral embolic protection (TCEP) devices have been developed to reduce this risk. Given the ongoing debate of TCEP in TAVI, we performed a systematic review and meta-analysis of all randomized controlled trials to date to identify outcomes of periprocedural stroke using the Sentinel™ cerebral protection system (CPS). MEDLINE, Cochrane, and Scopus databases were utilized from inception until 12/2023. PRISMA criteria was utilized. Keywords included "cerebral embolic protection", "sentinel cerebral protection system", "transcatheter aortic valve implantation", and "transcatheter aortic valve replacement". Primary outcome was periprocedural stroke. Secondary outcomes included periprocedural disabling and non-disabling stroke, all-cause mortality, transient ischemic attack, delirium, acute kidney injury, vascular complications, bleeding, and pacemaker implantation. Risk ratios (RR) were measured via Mantel-Haenszel method with fixed analysis. Heterogeneity was assessed via chi-squared and Higgin's I2 test. Four trials with 3528 patients were assessed. SAPIEN 3 was the most common bioprosthetic valve used. The average age was 79.4years with 41.9% of the sample size being females. The most prevalent comorbidities were hypertension, diabetes mellitus, and coronary artery disease. There was no difference in periprocedural stroke in patients who underwent TAVI with the Sentinel™ CPS compared to no TCEP (RR 0.75, P = 0.12). Periprocedural disabling strokes were less likely in those who underwent TAVI with the Sentinel™ CPS compared to no TCEP (RR 0.41, P = 0.02) with a number needed to treat (NNT) of 123. All other outcomes did not reach statistical significance. In our analysis, there was no difference between TAVI with the Sentinel™ CPS compared to TAVI without TCEP in regard to risk of periprocedural stroke; however, it was associated with a decreased risk of periprocedural disabling stroke.

Safety and efficacy of cerebral embolic protection in transcatheter aortic valve implantation: an updated meta-analysis.

The use of cerebral embolic protection devices during transcatheter aortic valve implantation (TAVI) reveals conflicting data. This updated meta-analysis aims to evaluate the efficacy and safety of the SENTINEL Cerebral Protection System. A literature search for relevant studies up to September 2022 was performed. Study outcomes were divided based on time period - overall (up to 30 days) and short (≤7 days). The outcomes studied include stroke (disabling, non-disabling), mortality, neuroimaging findings, transient ischaemic attack, acute kidney injury and major vascular and bleeding complications. A total of 15 studies involving 294,134 patients were included. Regarding overall outcomes, significant reductions were noted for mortality (odds ratio [OR] 0.60, 95% confidence interval [CI]: 0.41-0.88; p=0.008), all stroke (OR 0.64, 95% CI: 0.46-0.88; p=0.006) and disabling stroke (OR 0.42, 95% CI: 0.23-0.74; p=0.003) using the SENTINEL device. No significant differences were noted for other outcomes. There was significant heterogeneity across the studies for mortality (p=0.013) and all stroke (p=0.003). Including only randomised data (n=4), there was only significant reduction in the incidence of disabling stroke (OR 0.39, 95% CI: 0.17-0.89; p=0.026) in the SENTINEL group. In studies reporting ≤7-day outcomes (n=8), use of the SENTINEL device demonstrated significantly lower rates of all stroke (p<0.001), disabling stroke (p<0.001) and major bleeding complications (p=0.02). No differences in neuroimaging outcomes were noted. In this updated meta-analysis, use of the SENTINEL Cerebral Protection System was associated with lower rates of mortality, all stroke and disabling stroke, although significant heterogeneity was noted for mortality and all stroke. Including exclusively randomised data, there was only significant reduction in the incidence of disabling stroke. No significant adverse outcomes with device use were noted.

Impact of routine use of a cerebral protection device on the TAVR procedure and its short-term outcomes: a single-centre experience

Background Stroke is a major concern in transcatheter aortic valve replacement (TAVR). The introduction of a cerebral protection devices may counteract the evolution towards minimally invasive TAVR. At this time, there is insufficient data to support the routine use of these devices. Methods We aimed to evaluate the outcome of the routine use of the Sentinel Cerebral protection system® (CPS) in patients undergoing TAVR, after completing a CT-based screening process for feasibility of Sentinel implantation. We report our initial experience with the routine implementation of the Sentinel CPS in all anatomically suitable patients undergoing TAVR. We retrospectively compared the procedural characteristics and outcomes between all TAVR patients treated with (n = 78) and without (n = 79) intended Sentinel. Results The Sentinel CPS could successfully be deployed in 99% of intended cases after CT feasibility screening. TAVR procedures with Sentinel CPS were not longer than procedures without Sentinel use (89 ± 20 versus 120 ± 50 min, p = 0.007). Sentinel CPS use was not associated with an increased risk of procedural complications. Stroke was observed in none (0%) of the Sentinel CPS patients, and in 6.3% of the non-Sentinel CPS patients (p = 0.05). The finding of stroke was associated with a high risk of early postprocedural mortality: 60% of stroke patients died within 3 months. Conclusion Routine use of the Sentinel CPS in CT-screened TAVR patients is feasible with high procedural success, without significant adverse events and without counteracting the evolution towards minimally invasive TAVR. Clinically relevant stroke was observed in none of the Sentinel CPS patients.

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

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. 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. 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. 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.

Cerebral protection during percutaneous intervention for left ventricular assist device outflow graft obstruction.

Left ventricular assist devices (LVAD) outflow graft obstruction is an uncommon complication but carries significant morbidity and mortality. Here we provide a case series of patients with LVAD intrinsic outflow graft obstruction who are deemed to be a high surgical risk for pump exchange and, therefore, underwent percutaneous intervention with the concomitant use of neuroprotective device-Sentinel cerebral protection system(CPS)(Boston Scientific) to prevent embolic stroke. We retrospectively analyzed patients who underwent LVAD placement in our institution and developed LVAD outflow graft obstruction. The diagnosis of LVAD outflow graft obstruction was confirmed by utilizing various cardiac imaging modalities such as echocardiography and/or computed tomography angiography. All patients were treated with percutaneous intervention and a catheter-based CPS. From a total of 501 LVAD implants in our institute, 6 (1.2%) patients with LVAD outflow graft obstruction who underwent percutaneous treatment were included; 4 patients with HeartMate-IIILVAD, 1patient with HeartMate-II LVAD, and 1patient with HeartWare (HVAD). The median age of patients was 56.5 years at the time of LVAD implantation. The median time from the LVAD implantation to the episode of LVAD outflow obstruction was 1343 days. Utilization of Sentinel CPS resulted in the capture and removal of thrombus/debris in all patients. Percutaneous intervention of LVAD outflow graft obstruction is less invasive than surgical pump exchange and an acceptable alternative in properly selected patients. In our experience, utilization of a catheter-based CPScan help in reducing the incidence of periprocedural embolic events.

A Case of Successful Transcatheter Aortic Valve Replacement Using SENTINEL Cerebral Protection System for Severe Aortic Stenosis with Left Intracardiac Thrombus

A Case of Successful Transcatheter Aortic Valve Replacement Using SENTINEL Cerebral Protection System for Severe Aortic Stenosis with Left Intracardiac Thrombus

B-PO03-153 LEFT ATRIAL APPENDAGE OCCLUSION IN PATIENTS WITH PERSISTENT THROMBUS: A CASE SERIES

Percutaneous left atrial appendage (LAA) closure is contraindicated in patients with persistent LAA thrombus. This leaves a small number of patients at very high risk of future stroke. There are no established alternatives to treat these patients. Evaluate novel approaches to perform LAA closure in patients with persistent LAA thrombus. A retrospective review of Watchman™ implants performed at our institution to identify patients who were implanted with persistent LAA thrombus. Three patients underwent implantation of the Watchman device despite persistent LAA thrombus. The first patient had a Watchman 2.5 device and the other two underwent a Watchman flex device implant. All implants were performed with concurrent use of the Sentinel cerebral protection system (CPS). There were no periprocedural cerebrovascular events and all three patients were implanted successfully. Follow-up imaging at a 6-week interval showed a well-seated device and no evidence of device related thrombus or peri-device leaks. In patients with persistent LAA thrombus, implantation of the Watchman device appears to be safe and effective when performed with concurrent use of Sentinel cerebral protection system (CPS). A larger retrospective registry and further prospective data are needed to confirm these findings.

Effects of a dual-filter-based cerebral embolic protection device in transcatheter aortic valve replacement on cerebral oxygen saturation: A prospective pilot study.

The Sentinel Cerebral Protection System (Sentinel-CPS) is increasingly used in transcatheter aortic valve replacement (TAVR). However, the impact of inserting the Sentinel-CPS inside the brain-supplying arteries on cerebral perfusion and oxygenation is unknown. Twenty patients undergoing transfemoral TAVR with (n = 10) and without (n = 10) cerebral embolic protection using the Sentinel-CPS were prospectively observed. All patients received conscious sedation and cerebral oxygen saturation (rSO2 ) was continuously measured with near-infrared spectroscopy (NIRS). The cumulative perioperative cerebral desaturation was calculated for each patient by multiplying rSO2 below an individualized desaturation threshold by time. In addition, rSO2 values at the time of Sentinel-CPS insertion, filter positioning, and device retraction were analyzed. There was no significant difference in cumulative cerebral desaturation in patients with Sentinel-CPS (median [IQR]) (0 [0/81] s%) and without (median [IQR]) (0 [0/23] s%), p = .762. A total of 6 patients (33.3%) experienced a perioperative decrease in rSO2 below the individualized desaturation threshold (n = 3 with Sentinel-CPS, n = 3 without Sentinel-CPS; p = 1.000). Cerebral desaturation was detected during valve deployment (n = 5) and after postdilatation (n = 1). No desaturation events occurred during Sentinel-CPS insertion, filter positioning, or retraction. Our pilot study revealed no difference in cumulative perioperative cerebral desaturation between TAVR with and without Sentinel-CPS. Catheter- and filter-based manipulations in the brain-supplying arteries for Sentinel-CPS application were not associated with a decrease of cerebral perfusion and oxygenation.

Removal of Impella in the Setting of Left Ventricular Thrombus: A Potential Indication for Cerebral Embolic Protection Devices

Successful percutaneous mechanical circulatory support (MCS) has been used for acute stabilization of cardiogenic shock (CS). Improved survival outcomes have been observed in patients with CS from an acute myocardial infarction (AMI) who undergo implantation of left ventricular (LV) to ascending aorta rotodynamic pumps, such as the Impella® device (Abiomed). However, thrombotic events are a known complication of such devices in poor flow states such as CS. There is limited evidence regarding the management of patients who develop an LV thrombus after Impella insertion. Currently, the Sentinel cerebral protection system (SCPS, Boston Scientific) is the only FDA-approved device for cerebral embolic protection during transcatheter aortic valve replacement procedures. While the use of a cerebral embolic protection device (CEPD) has a theoretical benefit, no current CEPD is approved for use in conjunction with Impella device removal or other MCS devices. We present a case describing the use of the SCPS during the removal of the Impella CP device in a patient who developed an LV thrombus after CS from AMI. Our case highlights a potential role for the expanded use of CEPDs in similar clinical scenarios.

Ischemic Stroke With Cerebral Protection System During Transcatheter Aortic Valve Replacement

ObjectivesThe objective of this study was to evaluate in-hospital outcomes with use of the Sentinel cerebral protection system (CPS) in transcatheter aortic valve replacement (TAVR). BackgroundThe role of the Sentinel CPS in preventing clinical ischemic stroke has been controversial. MethodsThe Nationwide Inpatient Sample database from the last three quarters of 2017, after the approval of the Sentinel CPS device, was queried to identify hospitalizations for TAVR. A 1:2 propensity score–matched analysis to compare in-hospital outcomes with versus without use of the CPS. The primary outcome was the occurrence of ischemic strokes. ResultsA total of 36,220 weighted discharges of patients who underwent TAVR (525 with the CPS and 35,695 without) were identified. The overall percentages of ischemic and hemorrhagic strokes were 2.4% and 0.2%, respectively. After propensity score matching (525 CPS, 1,050 no CPS), the risk for ischemic stroke was lower with use of the CPS (1 % vs. 3.8%, odd ratio [OR]: 0.243 (95% confidence interval: 0.095 to 0.619); p = 0.003). The cost of the index hospitalization was higher with use of the CPS ($47,783 vs. $44,578; p = 0.002). In multivariate regression analysis, use of the CPS was independently associated with a lower risk for ischemic stroke (OR: 0.380; 95% confidence interval: 0.157 to 0.992; p = 0.032). ConclusionsUse of the Sentinel CPS in patients undergoing TAVR is associated with a lower incidence of ischemic stroke and in-hospital mortality, without an increased risk for procedural complications but with an increased cost of the index hospitalization.

Cerebral protection in left atrial appendage closure in the presence of appendage thrombosis.

Presence of thrombus in the left atrial appendage (LAA) remains a severe contraindication to the percutaneous left atrial appendage closure procedure (LAAC), due to increased embolic risk. Recently, the experience developed in cerebral protection device in transcatheter aortic valve implantation (TAVI) procedure was translated in LAAC to address this issue. To evaluate efficacy and safety of Sentinel cerebral protection system (CPS) in supporting LAAC in real-world patient with persistent LAA thrombus. The study retrospectively enrolled consecutive patients with non-valvular atrial fibrillation (NVAF) and thrombus in LAA who underwent LAAC supported by Sentinel CPS in seven European high-volume centres. Twenty-seven patients were included with a median age of 69.1 ± 9.7 years old, with median CHA2 DS2 -VASc and HAS-BLEED scores 3 [2-5] and 3 [2.75-4], respectively. Technical and procedural success was achieved in all patients. No periprocedural TIA, stroke, or supra-aortic trunks dissection was recorded. In this multicenter registry, LAAC supported by Sentinel CPS in patients with LAA persistent thrombus seems to be a safe and efficacious treatment.

Cerebral Embolic Protection to Prevent Brain Inury in Thoracic Aortic Stent-Grafting (TEVAR)

Introduction - Stroke occurs in 2-8%1 and silent cebebral infraction (SCI) in up to 63%2 of patients undergoing thoracic endovascular aortic repair (TEVAR). The Sentinel Cerebral Protection System (SCPS) is a dual filter cerebral embolic protection device (CEPD) that protects the innominate and left common carotid artery during intervention. CEPDs have been used successfully in patients undergoing transcatheter aortic valve insertion to reduce SCI and prevent neurolocognitive decline.3 This study investigates the safety and feasbility of CEPD with TEVAR. Methods - The SPCS was tested on a pulsatile flow model using all commercially available thoracic stent grafts to ensure compatibility. Patients anatomically suitable underwent TEVAR with SCPS. Procedural time for SCPS, complications, additional radiation exposure, fluoroscopy time and contrast dose was recorded. All patients had a pre and post-operative DW-MRI to assess number and surface area of new cerebral lesions, and neurocognitive testing. All filters were sent for histopathological analysis. Results - Ten patients,mean age 68yrs, anatomically suitable undwerwent TEVAR with SCPS, Fig 1. Proximal landing zones were1-3, aortic arch atheroma1-4. Success rate for SCPS was 90% (1 distal filter could not be deployed). There were no strokes, MACCE or device related complications. Use of SCPS added an additional 7mins to the total procedure,3.3mins fluoroscopy time, dose-area-product(mG.cm2) was increased by 2.2% and contrast use by 23mls. Nine patients underwent post-operative DW MRI, 2 had no new lesions. 23 lesions were identified in 7/9 patients, median number 1(1-3),surface area mm2 6(3-16); 6/23 (26%) were in the anterior circulation (AC), 15/23 (26%) in the posterior circulation(PC) and 2/23(9%) in borderzone territory. Debris capture rate was high in all filters 18/19(95%). Total number of particles captured was 2128, total surface area of particles 5,416,823.4μm2(5416mm2). There was no neurocognitive decline at 6 months. Conclusion - This is the first study to report use of CEPD in TEVAR. It appears safe and feasabile with high rate of debris capture, and reduced new cerebral lesions compared with neuroimaging data in TEVAR2.

Real-World Experience of the Sentinel Cerebral Protection Device: Insights From the FDA Manufacturer and User Facility Device Experience (MAUDE) Database

The Sentinel Cerebral Protection System (Boston Scientific, Marlborough, Massachusetts) is indicated for use as a cerebral protection device to capture and remove embolic material during transcatheter aortic valve procedures and was approved by the US Food and Drug Administration (FDA) in 2017. Robust data on the most commonly reported complications and modes of failure associated with the Sentinel device are limited. We analyzed postmarketing surveillance data from the FDA Manufacturer and User Facility Device Experience (MAUDE) database from 2017 through 2019, yielding 43 reports. Of the 43 reports of major complications involving Sentinel devices, 23 involved either death (3) or injury (20) related to the device. The 3 deaths were due to stroke, while 18 of the 20 injuries were reported as stroke. The other 20 reports were related to device modes of failure. Modes of failure were due to damaged device (5), difficulty retrieving/resheathing the device (5); package contamination (4), difficulty deploying the device (3), and, finally, complications with preparation (3). Our analysis of the MAUDE database demonstrates that in real-world practice, the Sentinel Cerebral Protection System may be associated with complications, including death, stroke, vascular injury, and difficulties with the device itself. The MAUDE database serves as an important tool for both physicians and manufacturers to optimize performance and clinical outcomes.

Clinical Outcomes of Sentinel Cerebral Protection System Use During Transcatheter Aortic Valve Replacement: A Systematic Review and Meta-Analysis

ObjectiveTo compare the clinical outcomes following transcatheter aortic valve replacement (TAVR) with and without the use of the Sentinel Cerebral Protection System (Sentinel CPS). BackgroundStroke occurs in 2–5% of patients at 30 days after TAVR and increases mortality >3 fold. The Sentinel CPS is the only FDA (Food and Drug Administration) approved cerebral embolic protection device. MethodsThe Cochrane Library, PubMed and Web of Science were searched for relevant studies for inclusion in the meta-analysis. Two authors independently screened and included studies comparing the clinical outcomes after TAVR with and without the Sentinel CPS. Risk of bias was assessed using the Cochrane tools (RoB2.0 and ROBINS-I). ResultsFour studies comparing 606 patients undergoing TAVR with Sentinel CPS to 724 without any embolic protection device were included. Sentinel CPS use was associated with lower rates of 30-day mortality [0.8% vs 2.7%; RR 0.34 (95% CI 0.12, 0.92) I2 = 0%], 30-day symptomatic stroke [3.5% vs 6.1%; RR 0.51 (95% CI 0.29, 0.90) I2 = 0] and major or life-threatening bleeding [3.3% vs 6.6%; RR 0.50 (0.26, 0.98) I2 = 16%]. There was no significant difference between the two arms in the incidence of acute kidney injury [0.8% vs 1%; RR 0.85 (95% CI 0.22, 3.24) I2 = 0%] and major vascular complications [5.1% vs 6%; RR 0.74 (0.33, 1.67) I2 = 45%]. ConclusionThe results suggest that Sentinel CPS use in TAVR is associated with a lower risk of stroke, mortality and major or life-threatening bleeding at 30 days.

Abstract 17063: The Potential Role of Sentinel Cerebral Protection System in Improving Outcomes of Transcatheter Aortic Valve Replacement Patients: A Meta-Analysis

Introduction: Stroke is still a major complication that is reported in 2-5% of patients at 30 days, after a transcatheter aortic valve replacement (TAVR). The Sentinel Cerebral Protection System (CPS) (Claret Medical Inc., Santa Rosa, CA. USA) is the only FDA approved cerebral embolic protection device (CEPD). This meta-analysis aims to assess the potential benefits of the routine use of CPS after TAVR. Methods: The Cochrane library, PubMed and Web of science were searched for relevant studies. Two authors independently screened and included studies that were randomized controlled trials or controlled observational studies comparing the use of Sentinel CPS with no CEPD in TAVR. Data was extracted and the risk of bias assessed using the Cochrane Collaboration tools (RoB2.0 and ROBINS-I). Results: Four studies (3 randomized controlled trials and 1 quasi experimental study) comparing 847 patients in whom sentinel CPS was used to 483 in whom it was not used. Two of the studies had low risk of bias and 2 had some concerns for risk of bias. The primary outcomes were the number or size of ischemic lesions on brain MRI in 2 studies, major cardiac and cerebrovascular events in 1 study and a composite of mortality or stroke in 1 study. Patients in whom Sentinel CPS was used had lower rates of 30-day clinical stroke (3.5% vs 6.1%; RR 0.51 [95% CI 0.29, 0.90] I 2 = 0%), 30-day mortality (0.8% vs 2.7%; RR 0.34 [95% CI 0.12, 0.92] I 2 = 0%) and major or life-threatening bleeding (3.3% vs 6.6%; RR 0.50 [95% CI 0.26, 0.98] I 2 = 16%). There was no significant difference between the two arms in the incidence of acute kidney injury (0.8% vs 1%; RR 0.85 [95% CI 0.22, 3.24] I 2 = 0%) and major vascular complications (5.1% vs 6%; RR 0.74 [95% CI 0.33, 1.67] I 2 = 45%). Conclusion: Sentinel CPS use in TAVR can be helpful in reducing the risk of stroke, mortality and major or life-threatening bleeding at 30 days.

TCT-589 Clinical Outcomes of the Sentinel Cerebral Protection System in Patients Undergoing Transcatheter Aortic Valve Replacement: A Meta-Analysis

Despite improvements in device design and risk of stroke following transcatheter aortic valve replacement (TAVR), the rate of stroke at 30 days remains between 2 – 5%. This meta-analysis pools the data for the only FDA approved CEPD, the Sentinel Cerebral Protection System (CPS) (Claret Medical

Overview of the 2017 US Food and Drug Administration Circulatory System Devices Panel meeting on the Sentinel Cerebral Protection System

Overview of the 2017 US Food and Drug Administration Circulatory System Devices Panel meeting on the Sentinel Cerebral Protection System

Filter-based cerebral embolic protection with transcatheter aortic valve implantation: the randomised MISTRAL-C trial.

Our aim was to determine whether use of the filter-based Sentinel™ Cerebral Protection System (CPS) during transcatheter aortic valve implantation (TAVI) can affect the early incidence of new brain lesions, as assessed by diffusion-weighted magnetic resonance imaging (DW-MRI), and neurocognitive performance. From January 2013 to July 2015, 65 patients were randomised 1:1 to transfemoral TAVI with or without the Sentinel CPS. Patients underwent DW-MRI and extensive neurological examination, including neurocognitive testing one day before and five to seven days after TAVI. Follow-up DW-MRI and neurocognitive testing was completed in 57% and 80%, respectively. New brain lesions were found in 78% of patients with follow-up MRI. Patients with the Sentinel CPS had numerically fewer new lesions and a smaller total lesion volume (95 mm3 [IQR 10-257] vs. 197 mm3 [95-525]). Overall, 27% of Sentinel CPS patients and 13% of control patients had no new lesions. Ten or more new brain lesions were found only in the control cohort (in 20% vs. 0% in the Sentinel CPS cohort, p=0.03). Neurocognitive deterioration was present in 4% of patients with Sentinel CPS vs. 27% of patients without (p=0.017). The filters captured debris in all patients with Sentinel CPS protection. Filter-based embolic protection captures debris en route to the brain in all patients undergoing TAVI. This study suggests that its use can lead to fewer and overall smaller new brain lesions, as assessed by MRI, and preservation of neurocognitive performance early after TAVI. Dutch trial register-ID: NTR4236. URL http://www.trialregister.nl/trialreg/admin/rctsearch.asp?Term=mistral.