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Utilization and Clinical Outcomes of Left Atrial Appendage Occlusion in Older Adults with Atrial Fibrillation and Frailty

Award Number: R01HL175560
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/01/2024
PERIOD OF PERFORMANCE END DATE: 04/30/2029

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Utilization and Clinical Outcomes of Left Atrial Appendage Occlusion in Older Adults with Atrial Fibrillation and Frailty - PROJECT SUMMARY One in every 3 persons develops atrial fibrillation (AF) in their lifetime, and AF affects at least 10% of adults aged ≥65 years. Stroke prophylaxis with oral anticoagulants (OAC) is recommended, but half of older adults who are eligible for OAC are not treated because of concerns for major bleeding. Treatment with OAC is even less frequent in adults with frailty, who have excess risk for major bleeding but also for ischemic stroke. To reduce AF risks in vulnerable populations, left atrial appendage occlusion (LAAO) was approved by Centers for Medicare & Medicaid Services (CMS) and is recommended by practice guidelines to provide AF stroke prevention for individuals deemed unsafe for long-term OAC. However, given its short-term procedural complications and life- long requirement for antiplatelet therapy, the overall benefit of LAAO among adults with frailty is unknown. In fact, because LAAO’s efficacy and safety were established against OAC in randomized controlled trials (RCT) of OAC-eligible patients, LAAO’s effectiveness and safety remain uncertain for the population most likely to benefit—patients with frailty or OAC ineligibility—resulting in a critical evidence-practice gap. The long-term goal of our AF Outcomes Research program is to improve evidence-based, patient-centered care for older adults with AF. To this end, our current objective is to evaluate utilization and outcomes of LAAO compared to therapeutic alternatives in older adults with frailty. We will utilize multiple real-world data sources and apply advanced causal inference methods to enhance generalizability and the validity of inference. In Aim 1 we will determine characteristics of older adults who received LAAO and characterize concordance of LAAO use with CMS approved and guideline recommended indication. In Aims 2 and 3 we will determine effectiveness, safety, and net benefit (home time) of LAAO compared to OAC and no OAC, respectively. In absence of RCTs, the proposed research will be the main source of evidence for guiding rational use of LAAO in vulnerable populations.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $722,754 )
2025	2025	HEBREW REHABILITATION CENTER	1200 CENTRE ST	ROSLINDALE	MA	02131	SUFFOLK	USA	Cardiovascular Diseases Research	000	2	3/31/2025	NON-COMPETING CONTINUATION	$650,478
2025	2025	HEBREW REHABILITATION CENTER	1200 CENTRE ST	ROSLINDALE	MA	02131	SUFFOLK	USA	Cardiovascular Diseases Research	001	2	7/1/2025	NON-COMPETING CONTINUATION	$72,276
														Subtotal = $722,754

Issue Date FY: 2024 ( Subtotal = $722,903 )
2024	2024	HEBREW REHABILITATION CENTER	1200 CENTRE ST	ROSLINDALE	MA	02131	SUFFOLK	USA	Cardiovascular Diseases Research	000	1	6/14/2024	NEW	$722,903
														Subtotal = $722,903

Grand Total All Awards = $1,445,657

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Utilization and Clinical Outcomes of Left Atrial Appendage Occlusion in Older Adults with Atrial Fibrillation and Frailty

Award Number: R01HL175560

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 07/01/2024

PERIOD OF PERFORMANCE END DATE: 04/30/2029

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