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Aortic Valve Replacement vs. Balloon-Expandable and Self-Expandable Transcatheter Implantation in Low-Risk Patients
 
 
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Volume 15
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10.3390/jcm15020914
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Systematic Review

Imaging and Clinical Outcomes with Sentinel Cerebral Embolic Protection During TAVR: A Meta-Analysis of Randomized Trials with Trial Sequential Analysis

by
Shanmukh Sai Pavan Lingamsetty
1,†,
Mangesh Kritya
2,†,
Priyanka Vatsavayi
3,
Chenna Reddy Tera
3,
Mohamed Doma
4,
Sahas Reddy Jitta
5,
Mohan Chandra Vinay Bharadwaj Gudiwada
6,
Jaswanth Jasti
7,
Adham Ramadan
8,
Venkata Vedantam
3,
Pedro A. Villablanca
9 and
Andrew M. Goldsweig
10,11,*
1
Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA 02115, USA
2
Department of Structural Heart, Houston Methodist Research Institute, Houston, TX 77030, USA
3
Department of Internal Medicine, East Tennessee State University (ETSU) Quillen College of Medicine, Johnson City, TN 37604, USA
4
Department of Cardiology, Massachusetts General Hospital, Boston, MA 02114, USA
5
Department of Internal Medicine, Mercy Health St. Louis, St. Louis, MO 63141, USA
6
Division of Cardiovascular Medicine, University of Nebraska Medical Center, Omaha, NE 68198, USA
7
Department of Cardiology, Tower Health Reading Hospital, West Reading, PA 19611, USA
8
Department of Internal Medicine, Boston Medical Center-Brighton South, Boston, MA 02135, USA
9
Division of Cardiovascular Medicine, Henry Ford Hospital, Detroit, MI 48202, USA
10
Department of Cardiovascular Medicine, Baystate Medical Center, Springfield, MA 01199, USA
11
Division of Cardiology, University of Massachusetts—Baystate, Springfield, MA 01199, USA
 
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*
Author to whom correspondence should be addressed.
†
These authors contributed equally to this paper.
J. Clin. Med. 2026, 15(2), 914; https://doi.org/10.3390/jcm15020914 (registering DOI)
Submission received: 2 January 2026 / Revised: 18 January 2026 / Accepted: 20 January 2026 / Published: 22 January 2026
(This article belongs to the Special Issue Transcatheter Aortic Valve Implantation: Recent Advances and Future Directions)
Versions Notes

Abstract

Background: Stroke and subclinical cerebral ischemia remain important neurological complications of transcatheter aortic valve replacement (TAVR). The Sentinel cerebral embolic protection (CEP) device is designed to capture embolic debris during TAVR, but its impact on clinical and imaging outcomes remains incompletely characterized. Methods: PubMed, Embase, and Cochrane databases were systematically searched for randomized controlled trials (RCTs) comparing Sentinel CEP versus no protection when TAVR was performed. Outcomes of interest included all stroke, disabling stroke, infarct volume by diffusion-weighted MRI in protected and unprotected areas, all-cause mortality, acute kidney injury, and major vascular complications. Risk ratios (RRs) and median differences with 95% confidence intervals (CIs) were calculated using random-effects models and trial sequential analysis (TSA) assessed evidence robustness. Results: Four RCTs including 10,986 patients were analyzed. Sentinel CEP did not significantly reduce clinical stroke (RR 0.88, 95% CI 0.69–1.12) or disabling stroke (RR 0.68, 95% CI 0.41–1.14). Pooled DW-MRI data showed a significant reduction in new ischemic lesion volume within Sentinel CEP-protected territories (difference in medians –75.7 mm3; 95% CI –130.4 to –21.0). Subgroup analyses in elderly, female, and high-surgical-risk patients revealed no benefit with Sentinel CEP. Additionally, TSA indicated that current data are underpowered for definitive conclusions. Conclusions: The Sentinel CEP device during TAVR did not significantly reduce clinical stroke but was associated with lower MRI-detected ischemic lesion volumes compared with no protection. Further adequately powered RCTs integrating clinical and imaging endpoints are needed to define its role in neuroprotection during TAVR.
Keywords: TAVR; CEP; stroke; sentinel TAVR; CEP; stroke; sentinel

Share and Cite

MDPI and ACS Style

Pavan Lingamsetty, S.S.; Kritya, M.; Vatsavayi, P.; Tera, C.R.; Doma, M.; Jitta, S.R.; Gudiwada, M.C.V.B.; Jasti, J.; Ramadan, A.; Vedantam, V.; et al. Imaging and Clinical Outcomes with Sentinel Cerebral Embolic Protection During TAVR: A Meta-Analysis of Randomized Trials with Trial Sequential Analysis. J. Clin. Med. 2026, 15, 914. https://doi.org/10.3390/jcm15020914

AMA Style

Pavan Lingamsetty SS, Kritya M, Vatsavayi P, Tera CR, Doma M, Jitta SR, Gudiwada MCVB, Jasti J, Ramadan A, Vedantam V, et al. Imaging and Clinical Outcomes with Sentinel Cerebral Embolic Protection During TAVR: A Meta-Analysis of Randomized Trials with Trial Sequential Analysis. Journal of Clinical Medicine. 2026; 15(2):914. https://doi.org/10.3390/jcm15020914

Chicago/Turabian Style

Pavan Lingamsetty, Shanmukh Sai, Mangesh Kritya, Priyanka Vatsavayi, Chenna Reddy Tera, Mohamed Doma, Sahas Reddy Jitta, Mohan Chandra Vinay Bharadwaj Gudiwada, Jaswanth Jasti, Adham Ramadan, Venkata Vedantam, and et al. 2026. "Imaging and Clinical Outcomes with Sentinel Cerebral Embolic Protection During TAVR: A Meta-Analysis of Randomized Trials with Trial Sequential Analysis" Journal of Clinical Medicine 15, no. 2: 914. https://doi.org/10.3390/jcm15020914

APA Style

Pavan Lingamsetty, S. S., Kritya, M., Vatsavayi, P., Tera, C. R., Doma, M., Jitta, S. R., Gudiwada, M. C. V. B., Jasti, J., Ramadan, A., Vedantam, V., Villablanca, P. A., & Goldsweig, A. M. (2026). Imaging and Clinical Outcomes with Sentinel Cerebral Embolic Protection During TAVR: A Meta-Analysis of Randomized Trials with Trial Sequential Analysis. Journal of Clinical Medicine, 15(2), 914. https://doi.org/10.3390/jcm15020914

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