Treffer: Sentinel Cerebral Protection System in TAVI: An Updated Meta-Analysis of Randomized and Propensity-Matched Studies.
Title:
Sentinel Cerebral Protection System in TAVI: An Updated Meta-Analysis of Randomized and Propensity-Matched Studies.
Authors:
Braite M; Hospital of Love, Barretos, São Paulo, Brazil., Portilho NP; Federal District Military Firefighter Brigade, Brasilia, Distrito Federal, Brazil., Lara LBSMC; IDOMED-Instituto de Educação Médica, Rio de janeiro, Brazil., Cavalcante DVS; University of North Texas Health Science Center, Fort Worth, Texas, USA., Scheffer EC; EMESCAM-Escola Superior de Ciências da Santa Casa de Misericórdia de Vitória, Espírito Santo, Brazil., Machado MF; UNIFIPMOC-Faculdades Integradas Pitágoras de Montes Claros, Minas Gerais, Brazil., Neto IQC; Department of Radiology, University of Wisconsin-Madison, Madison, Wisconsin, USA., Barbosa ERF; Military Police of Goias State, Valparaiso de Goias, Brazil., Tarantini G; Department of Cardiac, Thoracic and Vascular Sciences and Public Health, University of Padova, Padova, Italy.
Source:
Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions [Catheter Cardiovasc Interv] 2025 Dec; Vol. 106 (7), pp. 3919-3927. Date of Electronic Publication: 2025 Oct 21.
Publication Type:
Journal Article; Meta-Analysis; Systematic Review
Language:
English
Journal Info:
Publisher: Wiley-Liss Country of Publication: United States NLM ID: 100884139 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1522-726X (Electronic) Linking ISSN: 15221946 NLM ISO Abbreviation: Catheter Cardiovasc Interv Subsets: MEDLINE
Imprint Name(s):
Original Publication: New York, NY : Wiley-Liss, c1999-
MeSH Terms:
Embolic Protection Devices* , Transcatheter Aortic Valve Replacement*/adverse effects , Transcatheter Aortic Valve Replacement*/mortality , Transcatheter Aortic Valve Replacement*/instrumentation , Intracranial Embolism*/prevention & control , Intracranial Embolism*/mortality , Intracranial Embolism*/etiology , Stroke*/prevention & control , Stroke*/mortality , Stroke*/etiology , Aortic Valve Stenosis*/mortality , Aortic Valve Stenosis*/surgery , Aortic Valve Stenosis*/diagnostic imaging , Aortic Valve Stenosis*/physiopathology , Aortic Valve*/surgery , Aortic Valve*/physiopathology , Aortic Valve*/diagnostic imaging, Humans ; Randomized Controlled Trials as Topic ; Risk Factors ; Treatment Outcome ; Time Factors ; Hospital Mortality ; Risk Assessment ; Aged ; Aged, 80 and over ; Male ; Female ; Protective Factors ; Odds Ratio ; Acute Kidney Injury/prevention & control ; Acute Kidney Injury/etiology
References:
C. R. Smith, M. B. Leon, M. J. Mack, et al., “Transcatheter Versus Surgical Aortic‐Valve Replacement in High‐Risk Patients,” New England Journal of Medicine 364 (2011): 2187–2198, https://doi.org/10.1056/NEJMoa1103510.
J. D. Carroll, M. J. Mack, S. Vemulapalli, et al., “STS‐ACC TVT Registry of Transcatheter Aortic Valve Replacement,” The Annals of Thoracic Surgery 111 (2021): 701–722, https://doi.org/10.1016/j.athoracsur.2020.09.002.
N. M. Butala, R. Makkar, E. A. Secemsky, et al., “Cerebral Embolic Protection and Outcomes of Transcatheter Aortic Valve Replacement: Results From the Transcatheter Valve Therapy Registry,” Circulation 143 (2021): 2229–2240, https://doi.org/10.1161/CIRCINTERVENTIONS.123.013697.
T. Rogers, M. C. Alraies, R. Torguson, and R. Waksman, “Overview of the 2017 US Food and Drug Administration Circulatory System Devices Panel Meeting on the Sentinel Cerebral Protection System,” American Heart Journal 192 (2017): 113–119, https://doi.org/10.1016/j.ahj.2017.06.007.
H. Jain, N. Pervez, D. Dey, et al., “Efficacy of Sentinel Cerebral Embolic Protection Device in Transcatheter Aortic Valve Replacement: A Meta‐Analysis of Randomized Controlled Trials and Propensity Score‐Matched Studies,” Cardiology in Review, ahead of print, September 30, 2024, https://doi.org/10.1097/CRD.0000000000000797.
W. Harmouch, B. Karnkowska, R. Thakker, et al., “Cerebral Embolic Protection in Transcatheter Aortic Valve Implantation Using the Sentinel Cerebral Protection System: A Systematic Review and Meta‐Analysis,” Cardiology and Therapy 13 (2024): 299–314, https://doi.org/10.1007/s40119-024-00359-4.
R. K. Kharbanda, J. Kennedy, Z. Jamal, et al., “Routine Cerebral Embolic Protection During Transcatheter Aortic‐Valve Implantation,” New England Journal of Medicine 392, no. 24 (2025): 2403–2412, https://doi.org/10.1056/NEJMoa2415120.
J. P. T. Higgins, D. G. Altman, P. C. Gotzsche, et al., “The Cochrane Collaboration's Tool for Assessing Risk of Bias in Randomised Trials,” BMJ 343 (2011): d5928, https://doi.org/10.1136/bmj.d5928.
D. Moher, A. Liberati, J. Tetzlaff, and D. G. Altman, “Preferred Reporting Items for Systematic Reviews and Meta‐Analyses: The PRISMA Statement,” PLoS Medicine 6 (2009): e1000097, https://doi.org/10.1371/journal.pmed.1000097.
A. P. Kappetein, S. J. Head, P. Genereux, et al., “Updated Standardized Endpoint Definitions for Transcatheter Aortic Valve Implantation: The Valve Academic Research Consortium‐2 Consensus Document (VARC‐2),” supplement, European Journal of Cardio‐Thoracic Surgery 42, no. S5 (2012): S45–S60, https://doi.org/10.1093/ejcts/ezs533.
S. Balduzzi, G. Rücker, and G. Schwarzer, “How to Perform a Meta‐Analysis With R: A Practical Tutorial,” Evidence Based Mental Health 22 (2019): 153–160, https://doi.org/10.1136/ebmental-2019-300117.
S. R. Kapadia, R. Makkar, M. Leon, et al., “Cerebral Embolic Protection During Transcatheter Aortic‐Valve Replacement,” New England Journal of Medicine 387, no. 14 (2022): 1253–1263, https://doi.org/10.1056/NEJMoa2204961.
S. Haussig, N. Mangner, M. G. Dwyer, et al., “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,” Journal of the American Medical Association 316, no. 6 (2016): 592–601, https://doi.org/10.1001/jama.2016.10302.
N. M. Van Mieghem, L. van Gils, H. Ahmad, et al., “Filter‐Based Cerebral Embolic Protection With Transcatheter Aortic Valve Implantation: The Randomised MISTRAL‐C Trial,” EuroIntervention 12 (2016): 499–507, https://doi.org/10.4244/EIJV12I4A84.
S. R. Kapadia, S. Kodali, R. Makkar, et al., “Protection Against Cerebral Embolism During Transcatheter Aortic Valve Replacement,” Journal of the American College of Cardiology 69, no. 4 (2017): 367–377, https://doi.org/10.1016/j.jacc.2016.10.023.
A. M. Altibi, L. Alhuneafat, A. Jabri, A. Al‐Abdouh, and F. Ghanem, “Cerebral Embolic Protection Device Utilization and Outcomes in Transcatheter Aortic Valve Replacement: A Nationally Representative Propensity Matched Analysis,” Cardiovascular Revascularization Medicine 67 (2024): 112–114, https://doi.org/10.1016/j.carrev.2024.04.003.
C. Donà, M. Koschutnik, C. Nitsche, et al., “Cerebral Protection in TAVR—Can We Do Without? A Real‐World All‐Comer Intention‐to‐Treat Study—Impact on Stroke Rate, Length of Hospital Stay, and Twelve‐Month Mortality,” Journal of Personalized Medicine 12 (2022): 320, https://doi.org/10.3390/jpm12020320.
J. Seeger, B. Gonska, M. Otto, et al., “Cerebral Embolic Protection During Transcatheter Aortic Valve Replacement Significantly Reduces Death and Stroke Compared With Unprotected Procedures,” Journal of the American College of Cardiology: Cardiovascular Intervention 10, no. 22 (2017): 2297–2303, https://doi.org/10.1016/j.jcin.2017.06.037.
R. Didier, H. Le Breton, H. Eltchaninoff, et al., “Evolution of TAVI Patients and Techniques Over the Past Decade: The French TAVI Registries,” Archives of cardiovascular diseases 115, no. 4 (2022): 206–213, https://doi.org/10.1016/j.acvd.2022.04.004.
S. Shekhar, A. Krishnaswamy, G. Reed, R. Puri, J. Yun, and S. Kapadia, “Cerebral Embolic Protection in Valve‐in‐Valve Transcatheter Aortic Valve Replacement,” The American Journal of Cardiology 216 (2024): 110–111, https://doi.org/10.1016/j.amjcard.2024.02.013.
J. Zhang, X. Li, R. Tian, et al., “Outcomes of Cerebral Embolic Protection for Bicuspid Aortic Valve Stenosis Undergoing Transcatheter Aortic Valve Replacement,” Journal of the American Heart Association 12, no. 12 (2023): e028890, https://doi.org/10.1161/JAHA.122.028890.
S. Shekhar, A. Krishnaswamy, G. Reed, J. Yun, R. Puri, and S. Kapadia, “Early Outcomes With Cerebral Embolic Protection During Transcatheter Aortic Valve Replacement in Patients With Atrial Fibrillation,” Structural Heart 9 (2025): 100353, https://doi.org/10.1016/j.shj.2024.100353.
J. D. Carroll, M. J. Mack, S. Vemulapalli, et al., “STS‐ACC TVT Registry of Transcatheter Aortic Valve Replacement,” The Annals of Thoracic Surgery 111 (2021): 701–722, https://doi.org/10.1016/j.athoracsur.2020.09.002.
N. M. Butala, R. Makkar, E. A. Secemsky, et al., “Cerebral Embolic Protection and Outcomes of Transcatheter Aortic Valve Replacement: Results From the Transcatheter Valve Therapy Registry,” Circulation 143 (2021): 2229–2240, https://doi.org/10.1161/CIRCINTERVENTIONS.123.013697.
T. Rogers, M. C. Alraies, R. Torguson, and R. Waksman, “Overview of the 2017 US Food and Drug Administration Circulatory System Devices Panel Meeting on the Sentinel Cerebral Protection System,” American Heart Journal 192 (2017): 113–119, https://doi.org/10.1016/j.ahj.2017.06.007.
H. Jain, N. Pervez, D. Dey, et al., “Efficacy of Sentinel Cerebral Embolic Protection Device in Transcatheter Aortic Valve Replacement: A Meta‐Analysis of Randomized Controlled Trials and Propensity Score‐Matched Studies,” Cardiology in Review, ahead of print, September 30, 2024, https://doi.org/10.1097/CRD.0000000000000797.
W. Harmouch, B. Karnkowska, R. Thakker, et al., “Cerebral Embolic Protection in Transcatheter Aortic Valve Implantation Using the Sentinel Cerebral Protection System: A Systematic Review and Meta‐Analysis,” Cardiology and Therapy 13 (2024): 299–314, https://doi.org/10.1007/s40119-024-00359-4.
R. K. Kharbanda, J. Kennedy, Z. Jamal, et al., “Routine Cerebral Embolic Protection During Transcatheter Aortic‐Valve Implantation,” New England Journal of Medicine 392, no. 24 (2025): 2403–2412, https://doi.org/10.1056/NEJMoa2415120.
J. P. T. Higgins, D. G. Altman, P. C. Gotzsche, et al., “The Cochrane Collaboration's Tool for Assessing Risk of Bias in Randomised Trials,” BMJ 343 (2011): d5928, https://doi.org/10.1136/bmj.d5928.
D. Moher, A. Liberati, J. Tetzlaff, and D. G. Altman, “Preferred Reporting Items for Systematic Reviews and Meta‐Analyses: The PRISMA Statement,” PLoS Medicine 6 (2009): e1000097, https://doi.org/10.1371/journal.pmed.1000097.
A. P. Kappetein, S. J. Head, P. Genereux, et al., “Updated Standardized Endpoint Definitions for Transcatheter Aortic Valve Implantation: The Valve Academic Research Consortium‐2 Consensus Document (VARC‐2),” supplement, European Journal of Cardio‐Thoracic Surgery 42, no. S5 (2012): S45–S60, https://doi.org/10.1093/ejcts/ezs533.
S. Balduzzi, G. Rücker, and G. Schwarzer, “How to Perform a Meta‐Analysis With R: A Practical Tutorial,” Evidence Based Mental Health 22 (2019): 153–160, https://doi.org/10.1136/ebmental-2019-300117.
S. R. Kapadia, R. Makkar, M. Leon, et al., “Cerebral Embolic Protection During Transcatheter Aortic‐Valve Replacement,” New England Journal of Medicine 387, no. 14 (2022): 1253–1263, https://doi.org/10.1056/NEJMoa2204961.
S. Haussig, N. Mangner, M. G. Dwyer, et al., “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,” Journal of the American Medical Association 316, no. 6 (2016): 592–601, https://doi.org/10.1001/jama.2016.10302.
N. M. Van Mieghem, L. van Gils, H. Ahmad, et al., “Filter‐Based Cerebral Embolic Protection With Transcatheter Aortic Valve Implantation: The Randomised MISTRAL‐C Trial,” EuroIntervention 12 (2016): 499–507, https://doi.org/10.4244/EIJV12I4A84.
S. R. Kapadia, S. Kodali, R. Makkar, et al., “Protection Against Cerebral Embolism During Transcatheter Aortic Valve Replacement,” Journal of the American College of Cardiology 69, no. 4 (2017): 367–377, https://doi.org/10.1016/j.jacc.2016.10.023.
A. M. Altibi, L. Alhuneafat, A. Jabri, A. Al‐Abdouh, and F. Ghanem, “Cerebral Embolic Protection Device Utilization and Outcomes in Transcatheter Aortic Valve Replacement: A Nationally Representative Propensity Matched Analysis,” Cardiovascular Revascularization Medicine 67 (2024): 112–114, https://doi.org/10.1016/j.carrev.2024.04.003.
C. Donà, M. Koschutnik, C. Nitsche, et al., “Cerebral Protection in TAVR—Can We Do Without? A Real‐World All‐Comer Intention‐to‐Treat Study—Impact on Stroke Rate, Length of Hospital Stay, and Twelve‐Month Mortality,” Journal of Personalized Medicine 12 (2022): 320, https://doi.org/10.3390/jpm12020320.
J. Seeger, B. Gonska, M. Otto, et al., “Cerebral Embolic Protection During Transcatheter Aortic Valve Replacement Significantly Reduces Death and Stroke Compared With Unprotected Procedures,” Journal of the American College of Cardiology: Cardiovascular Intervention 10, no. 22 (2017): 2297–2303, https://doi.org/10.1016/j.jcin.2017.06.037.
R. Didier, H. Le Breton, H. Eltchaninoff, et al., “Evolution of TAVI Patients and Techniques Over the Past Decade: The French TAVI Registries,” Archives of cardiovascular diseases 115, no. 4 (2022): 206–213, https://doi.org/10.1016/j.acvd.2022.04.004.
S. Shekhar, A. Krishnaswamy, G. Reed, R. Puri, J. Yun, and S. Kapadia, “Cerebral Embolic Protection in Valve‐in‐Valve Transcatheter Aortic Valve Replacement,” The American Journal of Cardiology 216 (2024): 110–111, https://doi.org/10.1016/j.amjcard.2024.02.013.
J. Zhang, X. Li, R. Tian, et al., “Outcomes of Cerebral Embolic Protection for Bicuspid Aortic Valve Stenosis Undergoing Transcatheter Aortic Valve Replacement,” Journal of the American Heart Association 12, no. 12 (2023): e028890, https://doi.org/10.1161/JAHA.122.028890.
S. Shekhar, A. Krishnaswamy, G. Reed, J. Yun, R. Puri, and S. Kapadia, “Early Outcomes With Cerebral Embolic Protection During Transcatheter Aortic Valve Replacement in Patients With Atrial Fibrillation,” Structural Heart 9 (2025): 100353, https://doi.org/10.1016/j.shj.2024.100353.
Grant Information:
The authors received no specific funding for this work.
Contributed Indexing:
Keywords: cerebral embolic protection (CEP); meta‐analysis; transcatheter aortic valve implantation (TAVI)
Entry Date(s):
Date Created: 20251022 Date Completed: 20251205 Latest Revision: 20251231
Update Code:
20251231
DOI:
10.1002/ccd.70236
PMID:
41121677
Database:
MEDLINE
Weitere Informationen
Backgrounds: Stroke remains a serious complication of transcatheter aortic valve implantation (TAVI). The Sentinel cerebral embolic protection (CEP) system is designed to mitigate this risk by capturing embolic debris, but its clinical benefit remains uncertain.
Aims: This meta-analysis evaluated the impact of Sentinel CEP on stroke and related outcomes in TAVI.
Methods: PubMed, Embase, and Cochrane were searched for randomized controlled trials (RCTs) and propensity score-matched (PSM) studies comparing TAVI with and without Sentinel CEP. The outcomes were periprocedural ischemic stroke, total stroke, disabling stroke, 30-day mortality, in-hospital mortality, composite death or stroke, acute kidney injury (AKI), and major vascular complications. Risk ratios (RRs) with 95% confidence intervals (CIs) were pooled using a random-effects model.
Results: Eight studies (five RCTs, three PSM studies) encompassing 33,111 patients were analyzed, with 50.1% receiving Sentinel. In pooled analysis, Sentinel CEP significantly reduced 30-day mortality (RR 0.75, 95% CI 0.58-0.97; p = 0.03) and AKI (RR 0.90, 95% CI 0.82-0.98; p = 0.01). No significant effect was observed for periprocedural ischemic stroke (RR 0.92, CI 0.79-1.07; p = 0.28), total stroke (RR 0.79, CI 0.59-1.05; p = 0.10), in-hospital mortality (RR 0.86, CI 0.57-1.31; p = 0.47), composite death or stroke, or major vascular complications. RCT-only analyses confirmed no significant effect on any outcome.
Conclusions: Sentinel CEP was associated with lower 30-day mortality and AKI in pooled cohorts, but did not reduce stroke. The absence of benefit in RCTs underscores the need for further studies in high-risk TAVI populations.
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