دورية أكاديمية
Impact of Cerebral Embolic Protection Devices on Disabling Stroke After TAVR: Updated Results From the STS/ACC TVT Registry.
| العنوان: | Impact of Cerebral Embolic Protection Devices on Disabling Stroke After TAVR: Updated Results From the STS/ACC TVT Registry. |
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| المؤلفون: | Butala NM; Rocky Mountain Regional VA Medical Center, Aurora, CO (N.M.B.).; University of Colorado School of Medicine, Aurora (N.M.B., J.C.M.)., Kapadia SR; Cleveland Clinic Foundation, OH (S.K.)., Secemsky EA; Richard and Susan Smith Center for Outcomes Research, Beth Israel Deaconess Medical Center, Boston, MA (E.A.S., R.W.Y.)., Gallup D; Duke Clinical Research Institute, Durham, NC (D.G., A.S.K., S.V.)., Kosinski AS; Duke Clinical Research Institute, Durham, NC (D.G., A.S.K., S.V.)., Vemulapalli S; Duke Clinical Research Institute, Durham, NC (D.G., A.S.K., S.V.)., Messenger JC; University of Colorado School of Medicine, Aurora (N.M.B., J.C.M.)., Yeh RW; Richard and Susan Smith Center for Outcomes Research, Beth Israel Deaconess Medical Center, Boston, MA (E.A.S., R.W.Y.)., Cohen DJ; Cardiovascular Research Foundation, New York (D.J.C.).; St. Francis Hospital, Roslyn, NY (D.J.C.). |
| المصدر: | Circulation. Cardiovascular interventions [Circ Cardiovasc Interv] 2024 Sep; Vol. 17 (9), pp. e013697. Date of Electronic Publication: 2024 Jun 05. |
| نوع المنشور: | Journal Article; Multicenter Study |
| اللغة: | English |
| بيانات الدورية: | Publisher: Lippincott Williams & Wilkins Country of Publication: United States NLM ID: 101499602 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1941-7632 (Electronic) Linking ISSN: 19417640 NLM ISO Abbreviation: Circ Cardiovasc Interv Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: Hagerstown, MD : Lippincott Williams & Wilkins |
| مواضيع طبية MeSH: | Registries* , Transcatheter Aortic Valve Replacement*/adverse effects , Transcatheter Aortic Valve Replacement*/instrumentation , Transcatheter Aortic Valve Replacement*/mortality , Embolic Protection Devices* , Aortic Valve Stenosis*/surgery , Aortic Valve Stenosis*/diagnostic imaging , Aortic Valve Stenosis*/mortality , Aortic Valve Stenosis*/physiopathology, Humans ; Male ; Female ; Aged, 80 and over ; Aged ; Risk Factors ; Treatment Outcome ; Risk Assessment ; Time Factors ; United States/epidemiology ; Hospital Mortality ; Intracranial Embolism/prevention & control ; Intracranial Embolism/etiology ; Intracranial Embolism/mortality ; Disability Evaluation ; Stroke/prevention & control ; Stroke/mortality ; Stroke/etiology ; Stroke/diagnosis ; Protective Factors ; Retrospective Studies |
| مستخلص: | Background: Cerebral embolic protection devices (EPDs) were developed to mitigate the risk of stroke during transcatheter aortic valve replacement (TAVR), but their benefit remains unproven. In the PROTECTED-TAVR trial (Stroke Protection With Sentinel During Transcatheter), EPD use did not reduce periprocedural stroke (primary study outcome) but led to a 62% reduction in the secondary end point of disabling stroke. Given these results, the impact of EPDs during TAVR remains unclear. Methods: We used STS/ACC TVT registry data to examine the association between EPD use and a proxy for disabling stroke among transfemoral TAVR patients between January 2018 and June 2023. The primary outcome was in-hospital disabling stroke-defined as stroke associated with either in-hospital death or discharge to a nonhome location. We evaluated the association between EPD use and disabling stroke using instrumental variable analysis with a site-level preference for EPD use as the instrument-a quasi-experimental approach that can support causal inference. In addition, we performed a propensity score-based comparison using overlap weighting as a secondary analysis. Results: The study population consisted of 414 649 patients of whom 53 389 (12.9%) received an EPD. The unadjusted rate of in-hospital disabling stroke was 0.7% among the EPD group and 0.9% in the no-EPD group. EPD use was associated with a reduction in disabling stroke in both instrumental variable analysis (relative risk, 0.87 [95% CI, 0.73-1.00]) and propensity-weighted analysis (odds ratio, 0.79 [95% CI, 0.70-0.90]) but was not associated with a reduction in nondisabling stroke. In subgroup analyses, the benefit of EPD was greater among those with versus without prior stroke ( P Conclusions: In the largest study to date, among patients undergoing TAVR, EPD use was associated with a small, borderline significant reduction in stroke associated with death or discharge to a nonhome location (a proxy for disabling stroke) that is likely to be causal in nature. Taken together with previous mechanistic and clinical studies, these findings provide credible evidence that EPDs benefit patients undergoing TAVR. Competing Interests: The views expressed in this article are those of the authors and do not necessarily reflect the position or policy of the Department of Veterans Affairs, the US Government, or the National Institutes of Health. Dr Butala is supported by grants from the Boettcher Foundation and the American Heart Association and reports consulting fees from Shockwave Medical and Boston Scientific and consulting fees and ownership interest in HiLabs and Catch Bio, outside the current work. Dr Yeh is a Special Government Employee of the US Food and Drug Administration. He has institutional research grants with the US FDA, Boston Scientific, Abbott Vascular and Medtronic. He is a consultant for Abbott Vascular, Boston Scientific, Elixir Medical, InfraRedx, Medtronic, Shockwave Medical, and Zoll. Dr Messenger reports institutional grant support from Philips Medical Systems and Medtronic. Dr Cohen reports institutional research grants from Boston Scientific, Edwards Lifesciences, Medtronic, Abbott, Zoll, IRhythm, Corvia, Philips, CathWorks, and Ancora. He is a consultant to Abbott, Boston Scientific, Edwards Lifesciences, and Heartbeam. Dr Vemulapalli reports grants/contracts from: American College of Cardiology, Society of Thoracic Surgeons, National Institutes of Health (R01 and UG3), Cytokinetics, Abbott Vascular, Boston Scientific. Consulting/Advisory Board: Astra Zeneca, Medtronic, Boehringer Ingelheim, Veralox Therapeutics, Icon, HeartFlow, TotalCME. |
| التعليقات: | Comment in: Circ Cardiovasc Interv. 2024 Sep;17(9):e014374. doi: 10.1161/CIRCINTERVENTIONS.124.014374. (PMID: 38837134) |
| References: | N Engl J Med. 2019 May 2;380(18):1769-1770. (PMID: 31042831) Ann Thorac Surg. 2019 Apr;107(4):1097-1103. (PMID: 30529671) N Engl J Med. 2022 Oct 6;387(14):1253-1263. (PMID: 36121045) Circ Cardiovasc Interv. 2024 Sep;17(9):e013698. (PMID: 38837149) Am J Cardiol. 2016 Oct 1;118(7):1031-45. (PMID: 27634034) EuroIntervention. 2012 May 15;8(1):129-38. (PMID: 22391581) J Am Coll Cardiol. 2013 Sep 10;62(11):1026-34. (PMID: 23644082) JAMA. 2020 Jun 16;323(23):2417-2418. (PMID: 32369102) EuroIntervention. 2023 Apr 24;18(17):1428-1435. (PMID: 36706009) Circulation. 2021 Jun 8;143(23):2229-2240. (PMID: 33619968) |
| معلومات مُعتمدة: | K23 HL150290 United States HL NHLBI NIH HHS; K24 HL150321 United States HL NHLBI NIH HHS; R01 HL136708 United States HL NHLBI NIH HHS |
| فهرسة مساهمة: | Keywords: clinical studies; death; instrumental variable; outcomes research; stroke; transcatheter aortic valve replacement |
| تواريخ الأحداث: | Date Created: 20240605 Date Completed: 20240917 Latest Revision: 20240919 |
| رمز التحديث: | 20240919 |
| مُعرف محوري في PubMed: | PMC11408089 |
| DOI: | 10.1161/CIRCINTERVENTIONS.123.013697 |
| PMID: | 38837174 |
| قاعدة البيانات: | MEDLINE |
Full Text Finder | تدمد: | 1941-7632 |
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| DOI: | 10.1161/CIRCINTERVENTIONS.123.013697 |