Randomized Evaluation of TriGuard 3 Cerebral Embolic Protection After Transcatheter Aortic Valve Replacement

Nazif, Tamim; Moses, Jeffrey J.; Sharma, Rahul; Dhoble, Abhijeet; Rovin, Joshua D.; Brown, David L.; Horwitz, Philip; Makkar, Rajendra; Stoler, Robert C.; Forrest, John K.; Messé, Steven R.; Dickerman, Sarah; Brennan, Joseph; Zivadinov, Robert; Dwyer, Michael G.; Lansky, Alexandra J.

doi:10.1016/j.jcin.2020.11.011

Cited by 64 publications

(68 citation statements)

References 29 publications

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“…The early DEFLECT III trial demonstrated that the device was safe, with fewer ischaemic brain lesions on a diffusion-weighted MRI (11.5% vs. 26.9%; p < 0.05), reduced neurological deficits detected by NIHSS (3.1% vs. 15.4%; p < 0.05), and improved neurocognition compared with control subjects undergoing TAVI without cerebral protection (Table 3) [50]. However, the more recent REFLECT II trial was terminated early due to safety concerns in the active treatment arm, primarily driven by TAVI-related vascular complications [51].…”

Section: Cerebral Embolic Protectionmentioning

confidence: 99%

Neurocognitive Status after Aortic Valve Replacement: Differences between TAVI and Surgery

Aroney

Patterson

Allen

et al. 2021

JCM

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Over the past decade, indications for transcatheter aortic valve implantation (TAVI) have progressed rapidly—procedural numbers now exceed those of surgical aortic valve replacement (SAVR) in many countries, and TAVI is now a realistic and attractive alternative to SAVR in low-risk patients. Neurocognitive outcomes after TAVI and SAVR remain an issue and sit firmly under the spotlight as TAVI moves into low-risk cohorts. Cognitive decline and stroke carry a significant burden and predict future functional decline, reduced mobility, poor quality of life and increased mortality. Early TAVI trials used varying neurocognitive definitions, and outcomes differed significantly as a result. Recent international consensus statements defining endpoints following TAVI and SAVR have standardised neurological outcomes and facilitate interpretation and comparison between trials. The latest TAVI and SAVR trials have demonstrated more consistent and favourable neurocognitive outcomes for TAVI patients, and cerebral embolic protection devices offer the prospect of further refinement and improvement.

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Section: Cerebral Embolic Protectionmentioning

confidence: 99%

Neurocognitive Status after Aortic Valve Replacement: Differences between TAVI and Surgery

Aroney

Patterson

Allen

et al. 2021

JCM

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“…The device is heparin-coated to reduce thrombogenicity and increase lubricity. The full system also includes a delivery subsystem for crimping and loading the device into an 8F sheath [ 21 , 22 ].…”

Section: Methodsmentioning

confidence: 99%

Embolic Protection with the TriGuard 3 System in Nonagenarian Patients Undergoing Transcatheter Aortic Valve Replacement for Severe Aortic Stenosis

Lind

Jánosi

Totzeck

et al. 2022

JCM

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Background: Transcatheter aortic valve replacement (TAVR) improves the survival and life quality of nonagenarian patients with aortic stenosis. Stroke remains one of the most worrisome complications following TAVR. Cerebral embolic protection devices (CEPDs) may reduce neurological complications after TAVR. This study evaluated the safety and efficacy of CEPDs during TAVR in nonagenarian patients. Methods: Between January 2018 and October 2021, 869 patients underwent transfemoral TAVR (TF-TAVR) at our center. Of these, 51 (5.9%) patients were older than ninety years. In 33 consecutive nonagenarian patients, TF-TAVR was implanted without CEPDs using balloon-expandable valves (BEVs) and self-expandable valves (SEVs). Eighteen consecutive nonagenarians underwent TF-TAVR using a CEPD (CP group). Follow up period was in-hospital or 30 days after the procedure, respectively. Results: Minor access site complications occurred in two patients (3.9%) and were not CEPD-associated. Postinterventional delirium occurred in nine patients (17.6%). Periprocedural minor non-disabling stroke and delirium occurred in ten patients (19.6%). Periprocedural major fatal stroke occurred in two patients in the BEV group (3.9%). Two patients in the BEV group died due to postinterventional pneumonia with sepsis. The mortality rate was 7.8%. The results did not differ between the groups. Conclusions: Age alone is no longer a contraindication for TAVR. CEPD using the Triguard 3 system in nonagenarian TAVR patients was feasible and safe and did not increase access site complications.

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“…The TriGUARD 3 device provides full cerebral protection. In spite of that successful device positioning was only achieved in 59.3% of the patients in the REFLECT II trial [44]. Hence, a more reliable and efficacious coverage is crucial to effectively prevent cerebral embolization.…”

Section: Cerebral Embolic Protection In Tavrmentioning

confidence: 99%

“…In the REFLECT II trial [44], a large RCT (n=220), the composite safety endpoint was numerically higher in the TriGUARD group compared to the unprotected group (15.9% vs. 7.0%, p=0.11). The difference was however mainly driven by major Halim J, Cheng JM, den Heijer P, Schölzel BE, Vos J, Meuwissen M, et In this study, successful device positioning (coverage of all three major branches throughout the procedure) was only achieved in 59.3% of the patients.…”

Section: Clinical Datamentioning

confidence: 99%

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The Role of Cerebral Embolic Protection in Transcatheter Aortic Valve Replacement

2021

Journal of Clinical Cardiology

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In transcatheter aortic valve replacement (TAVR), stroke remains one of the most devastating complications. As a result, cerebral embolic protection devices (CEPD) have been developed to prevent cerebral embolization in order to lower the stroke risk. Emboli can either be filtered or deflected depending on the type of CEPD. The goal of this review is to provide an overview of all currently available CEPD and to discuss the results of the most relevant studies concerning cerebral embolic protection in TAVR.

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Randomized Evaluation of TriGuard 3 Cerebral Embolic Protection After Transcatheter Aortic Valve Replacement

Cited by 64 publications

References 29 publications

Neurocognitive Status after Aortic Valve Replacement: Differences between TAVI and Surgery

Neurocognitive Status after Aortic Valve Replacement: Differences between TAVI and Surgery

Embolic Protection with the TriGuard 3 System in Nonagenarian Patients Undergoing Transcatheter Aortic Valve Replacement for Severe Aortic Stenosis

The Role of Cerebral Embolic Protection in Transcatheter Aortic Valve Replacement

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