Cerebral Embolic Protection During Transcatheter Aortic Valve Replacement: a Systematic Review and Meta-analysis of Propensity Score Matched and Randomized Controlled Trials Using the Sentinel Cerebral Embolic Protection Device

Overview

Journal BMC Cardiovasc Disord

Publisher Biomed Central

Specialty Cardiology & Vascular Diseases

Date 2023 Jun 17

PMID 37330463

Authors

Mathias Wolfrum

Immanuel Justus Handerer

Federico Moccetti

Alexander Schmeisser

Ruediger C Braun-Dullaeus

Stefan Toggweiler

Affiliations

Soon will be listed here.

Abstract

Background: The Sentinel cerebral embolic protection device (CEP) aims to reduce the risk of stroke during transcatheter aortic valve replacement (TAVR). We performed a systematic review and meta-analysis of propensity score matched (PSM) and randomized controlled trials (RCT) investigating the effect of the Sentinel CEP to prevent strokes during TAVR.

Methods: Eligible trials were searched through PubMed, ISI Web of science databases, Cochrane database, and proceedings of major congresses. Primary outcome was stroke. Secondary outcomes included all-cause mortality, major or life-threatening bleeding, major vascular complications and acute kidney injury at discharge. Fixed and random effect models were used to calculate the pooled risk ratio (RR) with 95% confidence intervals (CI) and absolute risk difference (ARD).

Results: A total of 4066 patients from 4 RCTs (3'506 patients) and 1 PSM study (560 patients) were included. Use of Sentinel CEP was successful in 92% of patients and was associated with a significantly lower risk of stroke (RR: 0.67, 95% CI: 0.48-0.95, p = 0.02. ARD: -1.3%, 95% CI: -2.3 - -0.2, p = 0.02, number needed to treat (NNT) = 77), and a reduced risk of disabling stroke (RR: 0.33, 95% CI: 0.17-0.65. ARD: -0.9%, 95% CI: -1.5 - -0.3, p = 0.004, NNT = 111). Use of Sentinel CEP was associated with a lower risk of major or life-threatening bleeding (RR: 0.37, 95% CI: 0.16-0.87, p = 0.02). Risk for nondisabling stroke (RR: 0.93, 95% CI: 0.62-1.40, p = 0.73), all-cause mortality (RR: 0.70, 95% CI: 0.35-1.40, p = 0.31), major vascular complications (RR: 0.74, 95% CI: 0.33-1.67, p = 0.47) and acute kidney injury (RR: 0.74, 95% CI: 0.37-1.50, p = 0.40) were similar.

Conclusions: The use of CEP during TAVR was associated with lower risks of any stroke and disabling stroke with an NNT of 77 and 111, respectively.

Citing Articles

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

Harmouch W, Karnkowska B, Thakker R, Rasmussen P, Shalaby M, Khalife W Cardiol Ther. 2024; 13(2):299-314.

PMID: 38340292 PMC: 11093944. DOI: 10.1007/s40119-024-00359-4.

Comparison of outcomes of self-expanding versus balloon-expandable valves for transcatheter aortic valve replacement: a meta-analysis of randomized and propensity-matched studies.

Wang B, Mei Z, Ge X, Li Y, Zhou Q, Meng X BMC Cardiovasc Disord. 2023; 23(1):382.

PMID: 37525092 PMC: 10388567. DOI: 10.1186/s12872-023-03397-3.

References

Davlouros P, Mplani V, Koniari I, Tsigkas G, Hahalis G . Transcatheter aortic valve replacement and stroke: a comprehensive review. J Geriatr Cardiol. 2018; 15(1):95-104. PMC: 5803543. DOI: 10.11909/j.issn.1671-5411.2018.01.008. View

Nuis R, Van Mieghem N, Schultz C, Moelker A, van der Boon R, van Geuns R . Frequency and causes of stroke during or after transcatheter aortic valve implantation. Am J Cardiol. 2012; 109(11):1637-43. DOI: 10.1016/j.amjcard.2012.01.389. View

Adams D, Popma J, Reardon M, Yakubov S, Coselli J, Deeb G . Transcatheter aortic-valve replacement with a self-expanding prosthesis. N Engl J Med. 2014; 370(19):1790-8. DOI: 10.1056/NEJMoa1400590. View

Kapadia S, Kodali S, Makkar R, Mehran R, Lazar R, Zivadinov R . Protection Against Cerebral Embolism During Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2016; 69(4):367-377. DOI: 10.1016/j.jacc.2016.10.023. View

Bagur R, Solo K, Alghofaili S, Nombela-Franco L, Kwok C, Hayman S . Cerebral Embolic Protection Devices During Transcatheter Aortic Valve Implantation: Systematic Review and Meta-Analysis. Stroke. 2017; 48(5):1306-1315. DOI: 10.1161/STROKEAHA.116.015915. View

Schmidt T, Akdag O, Wohlmuth P, Thielsen T, Schewel D, Schewel J . Histological Findings and Predictors of Cerebral Debris From Transcatheter Aortic Valve Replacement: The ALSTER Experience. J Am Heart Assoc. 2016; 5(11). PMC: 5210356. DOI: 10.1161/JAHA.116.004399. View

Bjursten H, Norrving B, Ragnarsson S . Late stroke after transcatheter aortic valve replacement: a nationwide study. Sci Rep. 2021; 11(1):9593. PMC: 8100158. DOI: 10.1038/s41598-021-89217-0. View

Haussig S, Mangner N, Dwyer M, Lehmkuhl L, Lucke C, Woitek F . Effect of a Cerebral Protection Device on Brain Lesions Following Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Stenosis: The CLEAN-TAVI Randomized Clinical Trial. JAMA. 2016; 316(6):592-601. DOI: 10.1001/jama.2016.10302. View

Jobanputra Y, Jones B, Mohananey D, Fatima B, Kandregula K, Kapadia S . Cerebral protection devices for transcatheter aortic valve replacement. Expert Rev Med Devices. 2017; 14(7):529-543. DOI: 10.1080/17434440.2017.1347038. View

10.

Leon M, Smith C, Mack M, Miller D, Moses J, Svensson L . Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010; 363(17):1597-607. DOI: 10.1056/NEJMoa1008232. View

11.

Leon M, Smith C, Mack M, Makkar R, Svensson L, Kodali S . Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. 2016; 374(17):1609-20. DOI: 10.1056/NEJMoa1514616. View

12.

Van Mieghem N, van Gils L, Ahmad H, van Kesteren F, van der Werf H, Brueren G . Filter-based cerebral embolic protection with transcatheter aortic valve implantation: the randomised MISTRAL-C trial. EuroIntervention. 2016; 12(4):499-507. DOI: 10.4244/EIJV12I4A84. View

13.

Liberati A, Altman D, Tetzlaff J, Mulrow C, Gotzsche P, Ioannidis J . The PRISMA statement for reporting systematic reviews and meta-analyses of studies that evaluate healthcare interventions: explanation and elaboration. BMJ. 2009; 339:b2700. PMC: 2714672. DOI: 10.1136/bmj.b2700. View

14.

Mack M, Leon M, Thourani V, Makkar R, Kodali S, Russo M . Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med. 2019; 380(18):1695-1705. DOI: 10.1056/NEJMoa1814052. View

15.

Horsted Thyregod H, Steinbruchel D, Ihlemann N, Nissen H, Kjeldsen B, Petursson P . Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Severe Aortic Valve Stenosis: 1-Year Results From the All-Comers NOTION Randomized Clinical Trial. J Am Coll Cardiol. 2015; 65(20):2184-94. DOI: 10.1016/j.jacc.2015.03.014. View

16.

Vlastra W, Jimenez-Quevedo P, Tchetche D, Chandrasekhar J, de Brito Jr F, Barbanti M . Predictors, Incidence, and Outcomes of Patients Undergoing Transfemoral Transcatheter Aortic Valve Implantation Complicated by Stroke. Circ Cardiovasc Interv. 2019; 12(3):e007546. DOI: 10.1161/CIRCINTERVENTIONS.118.007546. View

17.

Kapadia S, Makkar R, Leon M, Abdel-Wahab M, Waggoner T, Massberg S . Cerebral Embolic Protection during Transcatheter Aortic-Valve Replacement. N Engl J Med. 2022; 387(14):1253-1263. DOI: 10.1056/NEJMoa2204961. View

18.

Taylor T, Davis P, Torner J, Holmes J, Meyer J, Jacobson M . Lifetime cost of stroke in the United States. Stroke. 1996; 27(9):1459-66. DOI: 10.1161/01.str.27.9.1459. View

19.

Kappetein A, Head S, Genereux P, Piazza N, Van Mieghem N, Blackstone E . Updated standardized endpoint definitions for transcatheter aortic valve implantation: the Valve Academic Research Consortium-2 consensus document. Eur Heart J. 2012; 33(19):2403-18. DOI: 10.1093/eurheartj/ehs255. View

20.

Werner N, Zeymer U, Schneider S, Bauer T, Gerckens U, Linke A . Incidence and Clinical Impact of Stroke Complicating Transcatheter Aortic Valve Implantation: Results From the German TAVI Registry. Catheter Cardiovasc Interv. 2016; 88(4):644-653. DOI: 10.1002/ccd.26612. View