Prevention and Management of Stroke After Transcatheter Aortic Valve Replacement: The Mount Sinai Stroke Initiative

HomeJournal of the American Heart AssociationVol. 12, No. 4Prevention and Management of Stroke After Transcatheter Aortic Valve Replacement: The Mount Sinai Stroke Initiative Open AccessLetterPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citations ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toOpen AccessLetterPDF/EPUBPrevention and Management of Stroke After Transcatheter Aortic Valve Replacement: The Mount Sinai Stroke Initiative Sahil Khera, MD, MPH, Anoop N. Koshy, MBBS, PhD, Gilbert H. L. Tang, MD, MSc, MBA, Pedro Moreno, MD, PhD, Roxana Mehran, MD, George D. Dangas, MD, PhD, David Bronster, MD, Annapoorna S. Kini, MD, Michael Fara, MD and Samin K. Sharma, MD Sahil KheraSahil Khera https://orcid.org/0000-0001-9777-5934 , Division of Interventional Cardiology, , Mount Sinai Hospital, , New York, , NY, Search for more papers by this author , Anoop N. KoshyAnoop N. Koshy https://orcid.org/0000-0002-8741-8631 , Division of Interventional Cardiology, , Mount Sinai Hospital, , New York, , NY, Search for more papers by this author , Gilbert H. L. TangGilbert H. L. Tang https://orcid.org/0000-0001-7219-990X , Department of Cardiovascular Surgery, , Mount Sinai Hospital, , New York, , NY, Search for more papers by this author , Pedro MorenoPedro Moreno , Division of Interventional Cardiology, , Mount Sinai Hospital, , New York, , NY, Search for more papers by this author , Roxana MehranRoxana Mehran https://orcid.org/0000-0002-5546-262X , Division of Interventional Cardiology, , Mount Sinai Hospital, , New York, , NY, Search for more papers by this author , George D. DangasGeorge D. Dangas https://orcid.org/0000-0001-7502-8049 , Division of Interventional Cardiology, , Mount Sinai Hospital, , New York, , NY, Search for more papers by this author , David BronsterDavid Bronster , Division of Neurology, , Mount Sinai Hospital, , New York, , NY, Search for more papers by this author , Annapoorna S. KiniAnnapoorna S. Kini https://orcid.org/0000-0002-7189-3307 , Division of Interventional Cardiology, , Mount Sinai Hospital, , New York, , NY, Search for more papers by this author , Michael FaraMichael Fara , Division of Neurology, , Mount Sinai Hospital, , New York, , NY, Search for more papers by this author and Samin K. SharmaSamin K. Sharma *Correspondence to: Samin K. Sharma, MD, The Zena and Michael A. Weiner Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1030, New York 10029‐6574, NY. Email: E-mail Address: [email protected] https://orcid.org/0000-0002-1888-0793 , Division of Interventional Cardiology, , Mount Sinai Hospital, , New York, , NY, Search for more papers by this author Originally published8 Feb 2023https://doi.org/10.1161/JAHA.122.028182Journal of the American Heart Association. 2023;12:e028182Other version(s) of this articleYou are viewing the most recent version of this article. Previous versions: February 8, 2023: Ahead of Print Stroke is a devastating complication following transcatheter aortic valve replacement (TAVR). Despite advancements in technology, procedural technique, operator experience, and use of cerebral embolic protection, stroke rates have remained unchanged.1, 2 There is a paucity of data on the optimal management of patients with stroke following TAVR. Timely decision‐making regarding the suitability for thrombolysis or mechanical thrombectomy in post‐TAVR patients with documented stroke can be challenging because of the inherent mechanism of stroke, high‐risk vascular anatomy, and patient comorbidities.3, 4 A multidisciplinary stroke initiative was established to develop an institutional algorithm for the risk mitigation and management of suspected stroke following TAVR. We present the results of our working group recommendations as well as preliminary findings 1 year after protocol implementation.The Mount Sinai Stroke Initiative included members from interventional cardiology, neurology, and cardiothoracic surgery. The aims of the working group were 2‐fold. First, based on expert consensus, we aimed to formalize institutional strategies to mitigate stroke risk in patients undergoing TAVR. Second, we proposed a streamlined protocol for the management of patients diagnosed with stroke after TAVR. After review of existing literature, the stroke prevention recommendations were avoidance of postprocedural balloon valvuloplasty when possible, pharmacotherapy (day before admission and heparin infusion in patients with CHA2DS2VASC ≥5 and minimizing anticoagulation interruption in patients undergoing TAVR), and selective cerebral embolic protection (any 1 of: severely calcified valves, bicuspid valves, valve‐in‐valve, prior stroke, patients with atrial fibrillation, and CHA2DS2VASC score≥5). A key objective of the stroke management protocol was to minimize decision points to reduce individual practitioner preferences. The management decision flowchart is shown in Figure A.Download figureDownload PowerPointFigure . Stroke management protocol (A) and management implemented pre‐ and post‐ the institutional protocol (B).A and B, Represent overall rates and management of stroke in the preprotocol (2017–2021) and postprotocol (2021–2022) period patients undergoing transcatheter aortic valve replacement. AKI indicates acute kidney injury; CrCl, creatinine clearance; CT/CTA, computerized tomography (angiography); GI, gastrointestinal; GU, genitourinary; ICH, intracranial hemorrhage; LVO, large vessel occlusion; MRI, magnetic resonance imaging; MT, mechanical thrombectomy; NIHSS, National Institutes of Health Stroke Scale; TAVR, transcatheter aortic valve replacement; and TPA, tissue plasminogen activator.Overall, 2133 transfemoral TAVR procedures from January 1, 2017 to July 10, 2022, were included. Stroke after TAVR was confirmed by the consulting neurologist based on clinical presentation and neuroimaging findings. The stroke protocol implementation date was March 4, 2021, and the patients were divided into 2 groups—preimplementation (N=1421) and postimplementation (N=712). Baseline characteristics were compared using χ2 test or Fisher exact test for categorical variables and paired t or Mann–Whitney U test for continuous variables. Predictors of stroke were evaluated using logistic regression and presented as odds ratios (OR) with 95% CI. A 2‐tailed P value <0.05 was considered statistically significant. All study outcomes are reported at 30‐days post‐TAVR. All statistical analyses were performed using Stata (13/MP, Texas, USA). The data are available from the corresponding author upon reasonable request. The study was approved by the Mount Sinai institutional review board, and informed consent was waived because of the retrospective nature of the data analysis.Stroke occurred in 54 (2.5%) patients, the majority of whom were in‐hospital (49 [2.3%]). Median NIH stroke score was 6 (range 4–14) and a majority of the strokes were disabling (n=29, 53.7%). There was only 1 hemorrhagic stroke. Most strokes occurred in the first 24 hours post‐TAVR (n=38, 70.4%) with median time from TAVR completion to stroke of 6 hours (interquartile range [IQR] 1–19 hours). Stroke occurred more frequently in patients with increasing age, Society of Thoracic Surgeons risk score, frailty, prior stroke, atrial fibrillation, balloon postdilation, and the use of self‐expanding valve (all P<0.05). Cerebral embolic protection was not associated with a reduction in stroke (OR, 0.65 [95% CI, 0.36–1.18]; P=0.158). In the entire study cohort, only 18.5% (n=10) of patients were treated with systemic tissue plasminogen activator (TPA, n=3) or mechanical thrombectomy (MT, n=7). The rest were managed conservatively.Those treated with TPA or MT tended to be younger, less frail, and had higher NIH stroke score when stroke‐code was activated (P<0.05). A numerically greater proportion of patients were managed with TPA or MT following institution of the TAVR stroke protocol (28.6% versus 15.0%, P=0.223). Patients who underwent treatment with TPA or MT had a significant reduction in NIH stroke score (pre TPA/MT 14 [IQR 9–21] versus post TPA/MT 5 [IQR 1–8], P=0.002) with no significant difference noted in those managed conservatively (NIH stroke score 5 [IQR, 3.5–9] versus 5 [IQR, 3–9], P=0.198) at discharge. Two of 3 patients who received TPA had major bleeding complications at vascular access site requiring surgical intervention. One patient (10%) in the MT group had a hemorrhagic conversion at the stroke location. Stroke was associated with higher 30‐day mortality (OR, 5.6 [95% CI, 1.9–16.7]; P=0.002) and vascular complications (OR, 9.1 [95% CI, 3.6–23.2]; P<0.001). A trend to lower 30‐day mortality was noted following implementation of the stroke protocol (1.83 versus 0.98, P=0.09). No significant difference in 30‐day mortality was noted across the pre‐ and postprotocol implementation period in patients who experienced stroke (7.5 versus 7.1%, P=0.726).Stroke rates decreased numerically from 2.8% in the preimplementation to 2.0% in the postimplementation period (P=0.306). Cerebral embolic protection increased from 37.4% to 44% (P=0.003), and postdilation rates decreased from 21.3% to 10.5% (P<0.001) in the postprotocol implementation period. After protocol implementation, all large‐vessel occlusions diagnosed within the time‐window were managed by MT (Figure B). One patient received TPA for disabling stroke without large‐vessel occlusion on computed tomography angiography. There were no vascular complications in the postimplementation period.Study limitations include that the potential for the observed change in the management of patients in the postimplementation period may reflect changes in the management of patients with stroke general.Stroke, despite its low incidence, is associated with significant morbidity and mortality after TAVR. Our stroke management protocol led to an increase in utilization of TPA or MT, which was associated with significant improvements in neurological function. These early data are promising, but large prospective studies are needed to further improve management strategies of stroke after TAVR.Sources of FundingNone.DisclosuresDr Khera is a consultant and proctor for Medtronic. He is a consultant for Abbott, Terumo, EastEnd Medical, and serves on the speaker's bureau for Zoll Medical. Dr Tang is a physician proctor and consultant for Medtronic, a consultant and physician advisory board member for Abbott Structural Heart, and physician advisory board member for JenaValve. Dr Mehran has received institutional research grants from Abbott, Abiomed, Applied Therapeutics, Arena, AstraZeneca, Bayer, Biosensors, Boston Scientific, Bristol Myers Squibb, CardiaWave, CellAegis, CERC, Chiesi, Concept Medical, CSL Behring, DSI, Insel Gruppe, Medtronic, Novartis Pharmaceuticals, OrbusNeich, Philips, Transverse Medical, and Zoll; has received personal fees from the American College of Cardiology, Boston Scientific, the California Institute for Regenerative Medicine, Cine‐Med Research, Janssen, WebMD, and the Society for Cardiovascular Angiography and Interventions; has received consulting fees paid to the institution from Abbott, Abiomed, AM‐Pharma, Alleviant Medical, Bayer, Beth Israel Deaconess, CardiaWave, CeloNova, Chiesi, Concept Medical, DSI, Duke University, Idorsia Pharmaceuticals, Medtronic, Novartis, and Philips; holds equity (<1%) in Applied Therapeutics, Elixir Medical, STEL, and CONTROLRAD (spouse); and is a scientific advisory board member for the American Medical Association and Biosensors (spouse). Dr Dangas has received personal fees from Biosensors and Philips. Dr Sharma has received speakers bureau fees from Abbott Vascular, Boston Scientific, and Cardiovascular Systems. The remaining authors have nothing to disclose.Footnotes*Correspondence to: Samin K. Sharma, MD, The Zena and Michael A. Weiner Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1030, New York 10029‐6574, NY. Email: samin.[email protected]orgFor Sources of Funding and Disclosures, see page 3.References1 Carroll JD, Mack MJ, Vemulapalli S, Herrmann HC, Gleason TG, Hanzel G, Deeb GM, Thourani VH, Cohen DJ, Desai N, et al. STS‐ACC TVT registry of transcatheter aortic valve replacement. J Am Coll Cardiol. 2020; 76:2492–2516. doi: 10.1016/j.jacc.2020.09.595CrossrefMedlineGoogle Scholar2 Kolte D, Khera S, Nazir S, Butala NM, Bhatt DL, Elmariah S. Trends in cerebral embolic protection device use and association with stroke following transcatheter aortic valve implantation. Am J Cardiol. 2021; 152:106–112. doi: 10.1016/j.amjcard.2021.04.038CrossrefMedlineGoogle Scholar3 Kosmidou I, Liu Y, Alu MC, Liu M, Madhavan M, Chakravarty T, Makkar R, Thourani VH, Biviano A, Kodali S, et al. Antithrombotic therapy and cardiovascular outcomes after transcatheter aortic valve replacement in patients with atrial fibrillation. J Am Coll Cardiol Interv. 2019; 12:1580–1589. doi: 10.1016/j.jcin.2019.06.001CrossrefGoogle Scholar4 Kapadia SR, Makkar R, Leon M, Abdel‐Wahab M, Waggoner T, Massberg S, Rottbauer W, Horr S, Sondergaard L, Karha J, et al. Cerebral embolic protection during transcatheter aortic‐valve replacement. N Engl J Med. 2022; 387:1253–1263. doi: 10.1056/NEJMoa2204961CrossrefMedlineGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetails February 21, 2023Vol 12, Issue 4Article InformationMetrics Copyright © 2023 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley BlackwellThis is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.https://doi.org/10.1161/JAHA.122.028182PMID: 36752233 Manuscript receivedSeptember 14, 2022Manuscript acceptedDecember 5, 2022Originally publishedFebruary 8, 2023 Keywordstranscatheter aortic valve replacementischemic attacktransientcerebrovascular disordersstrokeaortic valve stenosisclinical protocolsPDF download SubjectsAortic Valve Replacement/Transcatheter Aortic Valve ImplantationCatheter-Based Coronary and Valvular InterventionsCerebrovascular Disease/StrokeIschemic StrokeQuality and Outcomes