Clinical follow-up of left atrial appendage occlusion in patients with atrial fibrillation ineligible of oral anticoagulation treatment—a systematic review and meta-analysis

Q: What is the clinical evidence from this study?

Study design: Systematic Review. Population: Atrial fibrillation with increased risk of ischemic stroke and contraindication to oral anticoagulation (n=7951). Intervention: Percutaneous left atrial appendage occlusion vs. No stroke prevention (predicted risk). Primary outcome: Incidence rate of ischemic stroke (events per 100 patient-years) (74.7% risk reduction, 95% CI 1.08-1.77).

Frida Labori; Carl Bonander; Josefine Persson; Mikael Svensson

doi:10.1007/s10840-021-00953-9

February 13, 2021Journal of Interventional Cardiac ElectrophysiologyOpen Access

Clinical follow-up of left atrial appendage occlusion in patients with atrial fibrillation ineligible of oral anticoagulation treatment—a systematic review and meta-analysis

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Key result

Left atrial appendage occlusion reduced the risk of ischemic stroke by 74.7% compared to the predicted risk with no stroke prevention in patients with atrial fibrillation and contraindication to oral anticoagulation.

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Why the study?

Some patients with AF and increased ischemic stroke risk are ineligible for OAC due to contraindications, making percutaneous LAAO a potential preventive option whose long-term clinical effectiveness needed estimation.

Does percutaneous left atrial appendage occlusion (LAAO) reduce ischemic stroke in patients with atrial fibrillation and contraindication to oral anticoagulation compared to predicted risk with no stroke prevention?

Study Design

Type

Systematic Review (n=7,951)

Structured PICO

Does percutaneous left atrial appendage occlusion (LAAO) reduce ischemic stroke in patients with atrial fibrillation and contraindication to oral anticoagulation compared to predicted risk with no stroke prevention?

P

Population

7,951 patients with atrial fibrillation and contraindication to oral anticoagulation, followed for a weighted mean of 1.46 years after percutaneous left atrial appendage occlusion.

I

Intervention

Percutaneous left atrial appendage occlusion (LAAO) using various devices (Amplatzer cardiac plug, Amplatzer amulet, Watchman, WaveCrest, LAmbre), mostly followed by dual antiplatelet treatment (DAPT) for 1-6 months, then life-long single antiplatelet treatment.

C

Comparator

No stroke prevention (estimated through a predicted risk score in an untreated population, 5.5 per 100 patient-years at CHA2DS2-VASc 4).

O

Outcome

Incidence rate (events per 100 patient-years) of ischemic stroke, transient ischemic attack, major bleeding, and all-cause death after LAAO treatment.hard clinical

Main Result

Effect estimate: 74.7% risk reduction (95% CI 1.08-1.77)

Absolute Event Rate: 1.38% vs 5.5%

LAAO provides an effective stroke prevention strategy, reducing ischemic stroke risk by approximately 75% compared to predicted untreated risk, for AF patients who are ineligible for oral anticoagulation.

Limitations

Included studies were observational without control groups, requiring comparison to a predicted risk score.
Uncertainty estimates for effectiveness are based only on the statistical uncertainty associated with the predicted incidence rate.
Unclear if results are generalizable to populations with lower risk, as the average CHA2DS2-VASc score in the included studies was 4.32.
Observational studies without any control group (relies on predicted risk score for comparison)
Uncertainty estimates for effectiveness based only on statistical uncertainty of predicted incidence
Unclear if results are generalizable to populations with lower risk (mean CHA2DS2-VASc was 4.32)

Implication

Supports LAAO consideration in anticoagulation-contraindicated AF; hypothesis-generating pending randomized confirmation.

Abstract

Purpose The recommended stroke prevention for patients with atrial fibrillation (AF) and increased risk of ischemic stroke is oral anticoagulation (OAC). Parts of the patient population are not eligible due to contraindication, and percutaneous left atrial occlusion (LAAO) can then be a preventive treatment option. The aim of this systematic review and meta-analysis is to estimate the long-term clinical effectiveness of LAAO as stroke prevention in patients with AF, increased risk of ischemic stroke, and contraindication to OAC. Methods We performed a systematic review and meta-analysis, using Poisson random effect models, to estimate the incidence rate (events per 100 patient-years) of ischemic stroke, transient ischemic attack, major bleeding, and all-cause death after LAAO treatment. We also calculated the risk reduction of ischemic stroke with LAAO compared with no stroke prevention estimated through a predicted risk in an untreated population (5.5 per 100 patient-years). Results We included 29 observational studies in our meta-analysis, including 7 951 individuals and 12 211 patient-years. The mean CHA 2 DS 2 -VASc score among the patients in the included studies is 4.32. The pooled incidence rate of ischemic stroke is 1.38 per 100 patient-years (95% CI 1.08; 1.77). According to a meta-regression model, the estimated incidence rate of ischemic stroke at CHA 2 DS 2 -VASc 4 is 1.39 per 100 patient-years. This implies a risk reduction of 74.7% with LAAO compared to predicated risk with no stroke prevention. Conclusions Our results suggest that LAAO is effective as stroke prevention for patients with AF, increased risk of stroke, and contraindication to oral anticoagulation.

Discussion

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Cite This Study

Labori et al. (2021) conducted a systematic review in Atrial fibrillation with increased risk of ischemic stroke and contraindication to oral anticoagulation (n=7,951). Percutaneous left atrial appendage occlusion vs. No stroke prevention (predicted risk) was evaluated on Incidence rate of ischemic stroke (events per 100 patient-years) (74.7% risk reduction, 95% CI 1.08-1.77). Left atrial appendage occlusion reduced the risk of ischemic stroke by 74.7% compared to the predicted risk with no stroke prevention in patients with atrial fibrillation and contraindication to oral anticoagulation.

synapsesocial.com/papers/6a773346df493903fd1ebdab https://doi.org/10.1007/s10840-021-00953-9