Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare Beneficiaries Article Swipe
Emily P. Zeitler
,
Boyang Bian
,
Robert I. Griffiths
,
Dominic J. Allocco
,
Thomas Christen
,
Kristine Roy
,
David J. Cohen
,
Matthew R. Reynolds
·
YOU?
·
· 2024
· Open Access
·
· DOI: https://doi.org/10.1161/circoutcomes.124.011007
YOU?
·
· 2024
· Open Access
·
· DOI: https://doi.org/10.1161/circoutcomes.124.011007
BACKGROUND: Long-term outcomes following left atrial appendage occlusion outside clinical trials and small registries are largely unknown. Collecting these data was a condition of US market authorization of the WATCHMAN device. The aim of this analysis was to evaluate the rates of stroke, bleeding, and death among Medicare beneficiaries following left atrial appendage occlusion implantation during initial commercial availability of the WATCHMAN left atrial appendage occlusion device overall and in important subgroups. METHODS: All Medicare fee-for-service beneficiaries ≥65 years of age who underwent left atrial appendage occlusion from April 1, 2016, to August 31, 2020, were included based on the International Classification of Diseases, Tenth Revision , and Current Procedural Terminology codes. Over a 5-year follow-up period, the cumulative incidence over time of mortality, ischemic stroke, and major bleeding were calculated using the International Classification of Diseases, Tenth Revision , diagnosis codes for the full study cohort and within important prespecified subgroups. RESULTS: WATCHMAN recipients (n=48 763) were a median of 77 (interquartile range, 72–82) years of age, 42% female, and mostly White (93%). The median CHA 2 DS 2 VASc score was 4 (interquartile range, 3–5) with prior major bleeding in 42% and prior stroke in 12%. At 5 years, death occurred in 44%, bleeding in 15% (with higher risk early following implantation), and ischemic stroke in 7%. Each of these end points was more common with greater baseline age. Male patients had greater 5-year mortality than female patients (46.9% versus 40.6%), but there was no difference between sexes in the rates of ischemic stroke (6.6% versus 7.5%) or major bleeding (14.9% for both). WATCHMAN recipients with prior ischemic stroke or a major bleeding event were older and frailer; these groups had higher rates of ischemic stroke, major bleeding, and death. CONCLUSIONS: Compared with patients enrolled in the pivotal clinical trials, Medicare beneficiaries undergoing WATCHMAN implantation were older, more female, and had more comorbid conditions. Substantial long-term mortality and major bleeding following WATCHMAN reflect the high-risk nature of the patient population, while the ischemic stroke rate was relatively low (<1.5% per year).
Related Topics
Concepts
Medicine
Interquartile range
Left atrial appendage occlusion
Stroke (engine)
Atrial fibrillation
Cohort
Occlusion
Internal medicine
Surgery
Pediatrics
Warfarin
Mechanical engineering
Engineering
Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1161/circoutcomes.124.011007
- OA Status
- green
- References
- 26
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4403138594
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
-
https://openalex.org/W4403138594Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.1161/circoutcomes.124.011007Digital Object Identifier
- Title
-
Long-Term Clinical Outcomes Following the WATCHMAN Device Use in Medicare BeneficiariesWork title
- Type
-
articleOpenAlex work type
- Language
-
enPrimary language
- Publication year
-
2024Year of publication
- Publication date
-
2024-10-01Full publication date if available
- Authors
-
Emily P. Zeitler, Boyang Bian, Robert I. Griffiths, Dominic J. Allocco, Thomas Christen, Kristine Roy, David J. Cohen, Matthew R. ReynoldsList of authors in order
- Landing page
-
https://doi.org/10.1161/circoutcomes.124.011007Publisher landing page
- Open access
-
YesWhether a free full text is available
- OA status
-
greenOpen access status per OpenAlex
- OA URL
-
https://www.ncbi.nlm.nih.gov/pmc/articles/11485207Direct OA link when available
- Concepts
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Medicine, Interquartile range, Left atrial appendage occlusion, Stroke (engine), Atrial fibrillation, Cohort, Occlusion, Internal medicine, Surgery, Pediatrics, Warfarin, Mechanical engineering, EngineeringTop concepts (fields/topics) attached by OpenAlex
- Cited by
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0Total citation count in OpenAlex
- References (count)
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26Number of works referenced by this work
- Related works (count)
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10Other works algorithmically related by OpenAlex
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| abstract_inverted_index.comorbid | 314 |
| abstract_inverted_index.enrolled | 296 |
| abstract_inverted_index.evaluate | 38 |
| abstract_inverted_index.frailer; | 279 |
| abstract_inverted_index.included | 96 |
| abstract_inverted_index.ischemic | 124, 215, 254, 269, 286, 334 |
| abstract_inverted_index.occurred | 202 |
| abstract_inverted_index.outcomes | 2 |
| abstract_inverted_index.patients | 232, 239, 295 |
| abstract_inverted_index.unknown. | 16 |
| abstract_inverted_index.(<1.5% | 340 |
| abstract_inverted_index.Diseases, | 103, 136 |
| abstract_inverted_index.Long-term | 1 |
| abstract_inverted_index.appendage | 6, 52, 64, 85 |
| abstract_inverted_index.bleeding, | 43, 289 |
| abstract_inverted_index.condition | 22 |
| abstract_inverted_index.diagnosis | 140 |
| abstract_inverted_index.follow-up | 115 |
| abstract_inverted_index.following | 3, 49, 212, 322 |
| abstract_inverted_index.high-risk | 326 |
| abstract_inverted_index.important | 70, 149 |
| abstract_inverted_index.incidence | 119 |
| abstract_inverted_index.long-term | 317 |
| abstract_inverted_index.mortality | 236, 318 |
| abstract_inverted_index.occlusion | 7, 53, 65, 86 |
| abstract_inverted_index.underwent | 82 |
| abstract_inverted_index.Collecting | 17 |
| abstract_inverted_index.Procedural | 109 |
| abstract_inverted_index.calculated | 130 |
| abstract_inverted_index.commercial | 57 |
| abstract_inverted_index.cumulative | 118 |
| abstract_inverted_index.difference | 247 |
| abstract_inverted_index.mortality, | 123 |
| abstract_inverted_index.recipients | 154, 266 |
| abstract_inverted_index.registries | 13 |
| abstract_inverted_index.relatively | 338 |
| abstract_inverted_index.subgroups. | 71, 151 |
| abstract_inverted_index.undergoing | 304 |
| abstract_inverted_index.BACKGROUND: | 0 |
| abstract_inverted_index.Substantial | 316 |
| abstract_inverted_index.Terminology | 110 |
| abstract_inverted_index.conditions. | 315 |
| abstract_inverted_index.population, | 331 |
| abstract_inverted_index.CONCLUSIONS: | 292 |
| abstract_inverted_index.availability | 58 |
| abstract_inverted_index.implantation | 54, 306 |
| abstract_inverted_index.prespecified | 150 |
| abstract_inverted_index.International | 100, 133 |
| abstract_inverted_index.authorization | 26 |
| abstract_inverted_index.beneficiaries | 48, 76, 303 |
| abstract_inverted_index.(interquartile | 162, 184 |
| abstract_inverted_index.Classification | 101, 134 |
| abstract_inverted_index.implantation), | 213 |
| abstract_inverted_index.fee-for-service | 75 |
| cited_by_percentile_year | |
| countries_distinct_count | 1 |
| institutions_distinct_count | 8 |
| sustainable_development_goals[0].id | https://metadata.un.org/sdg/3 |
| sustainable_development_goals[0].score | 0.7799999713897705 |
| sustainable_development_goals[0].display_name | Good health and well-being |
| citation_normalized_percentile.value | 0.33097626 |
| citation_normalized_percentile.is_in_top_1_percent | False |
| citation_normalized_percentile.is_in_top_10_percent | False |