What question did this study set out to answer?

To assess the rates of thromboembolic and bleeding complications over a two-year follow-up in patients with non-valvular atrial fibrillation undergoing left atrial appendage closure compared to risk-score predictions.

January 8, 2015HeartOpen Access

Two-year clinical outcome from the Iberian registry patients after left atrial appendage closure

Q: What is the clinical evidence from this study?

Study design: Observational. Population: Non-valvular atrial fibrillation (NVAF) (n=167). Intervention: Left atrial appendage (LAA) closure with an occlusion device vs. Expected event rates from CHADS2, CHA2DS2-VASc, and HAS-BLED risk scores. Primary outcome: Stroke/transient ischaemic attack events (annual event rate compared to CHADS2 expected) (p=<0.001).

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Key result

Left atrial appendage closure in NVAF patients contraindicated for oral anticoagulants was associated with lower annual rates of stroke/TIA (2.4% vs 9.6%, p<0.001) than expected from CHADS2 scores.

Why the study?

Does left atrial appendage closure reduce thromboembolic and haemorrhagic events compared to predicted risk scores in NVAF patients contraindicated for oral anticoagulants?

Key Points

To assess the rates of thromboembolic and bleeding complications over a two-year follow-up in patients with non-valvular atrial fibrillation undergoing left atrial appendage closure compared to risk-score predictions.
Analyzed 167 patients with non-valvular atrial fibrillation and contraindications to oral anticoagulants recruited across 12 hospitals between 2009 and 2013.
Tracked patients (mean age 74.68±8.58 years) over a median follow-up of 24 months, with protocol requiring at least two transoesophageal echocardiograms in the first 6 months and postimplantation clopidogrel and aspirin.
Implantation was successful in 94.6% of subjects with a 5.38% intraoperative complication rate; overall follow-up mortality was 10.8% (9.5% non-cardiac).
Annualized rates of stroke or transient ischaemic attack were 2.4%, significantly lower than predicted by CHADS2 (9.6%, p<0.001) and CHA2DS2-VASc (8.3%, p=0.003).
Annualized major bleeding occurred at a rate of 3.1%, significantly below the 6.6% rate predicted by HAS-BLED scores (p=0.047).

Study Design

Type

Observational (n=167)

Multicenter

Yes

Structured PICO

Does left atrial appendage closure reduce thromboembolic and haemorrhagic events compared to predicted risk scores in NVAF patients contraindicated for oral anticoagulants?

Population

167 patients with non-valvular atrial fibrillation contraindicated for oral anticoagulants who underwent left atrial appendage closure, followed for a median of 24 months.

Exposure

Left atrial appendage (LAA) closure with an occlusion device, followed by antithrombotics including clopidogrel and aspirin.

Comparator

Expected event rates based on CHADS2, CHA2DS2-VASc, and HAS-BLED risk scores.

Outcome

Percentage of thromboembolic and haemorrhagic events over a 2-year follow-up.hard clinical

Main Result

Absolute Event Rate: 2.4% vs 9.6%

p-value: p=<0.001

LAA closure in NVAF patients contraindicated for oral anticoagulants is associated with significantly lower rates of thromboembolic and hemorrhagic events than predicted by standard risk scores at 2 years.

Discussion

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Implication

Hypothesis-generating for LAA closure in contraindicated NVAF; should not change practice without randomized confirmation.

Cite This Study

López-Mínguez et al. (2015) conducted an observational in Non-valvular atrial fibrillation (NVAF) (n=167). Left atrial appendage (LAA) closure with an occlusion device vs. Expected event rates from CHADS2, CHA2DS2-VASc, and HAS-BLED risk scores was evaluated on Stroke/transient ischaemic attack events (annual event rate compared to CHADS2 expected) (p=<0.001). Left atrial appendage closure in NVAF patients contraindicated for oral anticoagulants was associated with lower annual rates of stroke/TIA (2.4% vs 9.6%, p<0.001) than expected from CHADS2 scores.

synapsesocial.com/papers/6a773347df493903fd1ebdad https://doi.org/10.1136/heartjnl-2014-306332

Topics

Left atrial appendage closure Atrial fibrillation Persistent AF management Anticoagulation in AF AF ablation outcomes

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Two-year clinical outcome from the Iberian registry patients after left atrial appendage closure

Key Points

Study Design

Structured PICO

Main Result

Discussion

Implication

Cite This Study

Topics

Two-year clinical outcome from the Iberian registry patients after left atrial appendage closure

Key Points

Study Design

Structured PICO

Main Result

Discussion

Implication

Cite This Study

Also Consider

Topics

Also Consider