Outcomes of Combined Left Atrial Appendage Occlusion and Transcatheter Mitral Edge-to-Edge Repair

Q: What is the clinical evidence from this study?

Study design: Cohort. Population: Atrial fibrillation and severe mitral regurgitation (n=24). Intervention: Combined LAAO (WATCHMAN-FLX) and MTEER (MitraClip). Primary outcome: Composite of all-cause mortality, stroke, and life-threatening or major bleeding at 45 days (95% CI 5%-37%).

Q: What does this research mean for the field?

Combined LAAO and transcatheter mitral edge-to-edge repair is feasible, resulting in a 45-day composite of mortality, stroke, or major bleeding in 21% of patients. Novelty: ClaimNovelty.NOVEL_FINDING. Consensus alignment: ConsensusAlignment.NEUTRAL.

Abdullah Al‐Abcha; Pietro Di Santo; Charanjit S. Rihal; Trevor Simard; Benjamin Hibbert; Mohamad Alkhouli

doi:10.1016/j.jacadv.2024.101541

January 8, 2025JACC AdvancesOpen Access

Outcomes of Combined Left Atrial Appendage Occlusion and Transcatheter Mitral Edge-to-Edge Repair

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Key result

Combined LAAO and MTEER yields a ~21% 45-day safety event rate, all nonprocedural.

95% CI 5%-37%
n=24

Why the study?

Up to 50% of patients undergoing MTEER have an indication for LAAO, but prospective evaluation of combining these procedures is lacking.

Is combined transcatheter mitral edge-to-edge repair and left atrial appendage occlusion feasible and safe in patients with indications for both procedures?

Study Design

Type

Cohort (n=24)

Multicenter

Yes

Structured PICO

Is combined transcatheter mitral edge-to-edge repair and left atrial appendage occlusion feasible and safe in patients with indications for both procedures?

P

Population

24 high-risk patients (mean age 79.5 years, 83% male) with concurrent clinical indications for mitral transcatheter edge-to-edge repair and left atrial appendage occlusion, followed for up to 1 year.

E

Exposure

Concomitant mitral transcatheter edge-to-edge repair (MTEER) with MitraClip and left atrial appendage occlusion (LAAO) with WATCHMAN FLX during a single procedure.

O

Outcome

Composite of all-cause mortality, stroke, and life-threatening or major bleeding at 45 days.composite

Combining left atrial appendage occlusion with transcatheter mitral edge-to-edge repair is technically feasible and safe in selected high-risk patients, offering a '1-stop' strategy.

Limitations

Early single-arm feasibility study with a small sample size
Enrolled patients who have high-prohibitive surgical risk, limiting generalizability
No comparative arm
No core-lab to adjudicate imaging findings
Incomplete 1-year follow-up data for some patients
Off-label use of DAPT as an alternative therapy for post-LAAO antithrombotic regimen
Early single-arm feasibility study with a small sample size.
Enrolled patients who have high-prohibitive surgical risk, which does not reflect the current national practice with MTEER.
No comparative arm of patients treated with MTEER and LAAO in separate settings.
No core-lab to adjudicate imaging findings.
1-year follow-up data is incomplete in 4 patients.
Some patients were discharged on DAPT, which is considered an off-label use for post-LAAO antithrombotic regimen.
Durability of MR reduction was lower than anticipated.

Implication

Supports combined LAAO-MTEER feasibility in high-risk patients; leaves open need for randomized trials before practice change.

Abstract

Background: Up to 50% of patients undergoing mitral transcatheter edge-to-edge repair (MTEER) have an indication for left atrial appendage occlusion (LAAO). However, prospective evaluation of this strategy is lacking. Objectives: The aim of the study was to prospectively evaluate the outcomes of combined LAAO and MTEER. Methods: The WATCH-TEER study is a prospective multicenter registry that aims to assess the feasibility and safety of concomitant MTEER with MitraClip and LAAO with WATCHMAN-FLX in patients with an approved clinical indication for both procedures. The primary endpoint was a composite of all-cause mortality, stroke, life-threatening, or major bleeding at 45 days. Results: A total of 24 patients were included between October 2020 and March 2024. Mean age was 79.5 ± 6.3 years, and 83% were males. The Society of Thoracic Surgeons operative risk score was 11.8% ± 5.3%, the CHA2DS2-VASc score was 4.5 ± 1.1, and the HAS-BLED score was 3.3 ± 1.5. Total procedure time was 103.6 ± 33.7 minutes. At 45 days, the primary endpoint occurred in 21% (95% CI: 5%-37%, n = 5/24) of patients, all of which occurred after discharge including 1 cardiac death, 1 ischemic stroke, 1 trauma-related intracranial hemorrhage, and 2 nonprocedural major bleeds. At 45 days, most patients (68%) had ≤2+ mitral regurgitation, and 72% of patients were in NYHA functional class I-II symptoms. Additionally, 71% of patients were not on anticoagulation, compared with only 20% at baseline. Conclusions: Combining LAAO with MTEER is feasible in patients who have a clinical indication for both procedures.

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Published by JACC Advances · CC BY

Cite This Study

Al‐Abcha et al. (2025) conducted a cohort in Atrial fibrillation and severe mitral regurgitation (n=24). Combined LAAO (WATCHMAN-FLX) and MTEER (MitraClip) was evaluated on Composite of all-cause mortality, stroke, and life-threatening or major bleeding at 45 days (95% CI 5%-37%). Combined LAAO and MTEER was feasible with a 45-day primary composite safety endpoint occurring in 21% of patients, all of which were nonprocedural.

synapsesocial.com/papers/6a210f3e01cd1e967e1e39db https://doi.org/10.1016/j.jacadv.2024.101541