What is the clinical evidence from this study?

Study design: Observational. Population: Non-valvular atrial fibrillation with OAC ineligibility (n=189). Intervention: Amplatzer Amulet vs. Watchman device. Primary outcome: Thromboembolic event (stroke and systemic embolization) at 6 months (OR 1.22, 95% CI 0.04-30.70, p=1.00).

What does this research mean for the field?

Left atrial appendage closure with the Amplatzer Amulet and Watchman devices achieves similar procedural success rates and comparably low rates of 6-month thromboembolic events and peri-device leaks in real-world clinical practice. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

August 20, 2018BMC Cardiovascular DisordersOpen Access

Real-world experience comparing two common left atrial appendage closure devices

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Key result

Amulet shows no difference in 6-month thromboembolic events compared to Watchman for LAAC.

OR 1.22
95% CI 0.04-30.70
P=1.00
n=189

Why the study?

Interventional left atrial appendage closure is a guideline-conform alternative to oral anticoagulation in non-valvular atrial fibrillation patients with OAC ineligibility, but direct comparisons of contemporary devices in real-world populations are lacking.

Does the Amplatzer Amulet device compared to the Watchman device improve procedural success or safety in patients with non-valvular atrial fibrillation ineligible for oral anticoagulation?

Study Design

Type

Observational (n=189)

Multicenter

Yes

Structured PICO

Does the Amplatzer Amulet device compared to the Watchman device improve procedural success or safety in patients with non-valvular atrial fibrillation ineligible for oral anticoagulation?

Population

189 patients with non-valvular atrial fibrillation and contraindications to long-term oral anticoagulation who underwent left atrial appendage closure, followed for 6 months.

Exposure

Left atrial appendage closure with Amplatzer Amulet device

Comparator

Left atrial appendage closure with Watchman device

Outcome

Procedural success, intra-hospital events, and event rates during 6 months follow-up (including peri-device leaks and thromboembolic events)safety

Main Result

Odds Ratio: 1.22 (95% CI 0.04–30.7)

Absolute Event Rate: 0% vs 0.9%

p-value: p=1.00

Both Watchman and Amplatzer Amulet devices demonstrate high procedural success and low follow-up complication rates for left atrial appendage closure, though access site bleeding may be higher with the Amplatzer device.

Limitations

Retrospective observational registry design with inherent selection bias
Imbalance in the total number of device implantations per group (154 vs 35)
Subjective assessment and documentation of bleeding events by treating physicians
Follow-up transoesophageal echocardiography was available in only 69% and 62% of successfully implanted patients
Follow-up period limited to 6 months
Limited sample size may have contributed to non-detection of infrequent thromboembolic events
retrospective approach

Implication

Supports similar short-term thromboembolic protection with either device; leaves open procedural safety questions in observational data.

Abstract

BACKGROUND: The interventional left atrial appendage closure (LAAC) is a guideline-conform alternative to oral anticoagulation (OAC) in non-valvular atrial fibrillation patients with OAC ineligibility. It was aimed to directly compare two contemporary devices in a real-world patient population. METHODS: LAAC was conducted in two centres between 2010 and 2014 as well as between 2014 and 2017, respectively, in a standard fashion based on the specific manufacturer's recommendations. Baseline characteristics, procedural data and event rates during intra-hospital and 6 months follow-up were registered in a retrospective approach, and analysed in device-related groups. RESULTS: A total of 189 patients presented for LAAC device implantation. Baseline characteristics were mostly evenly distributed. In 148 patients, a Watchman™ device (Boston Scientific, Natick, MA, USA) was successfully implanted, an Amplatzer™ Amulet™ (St. Jude Medical, St. Paul, MN, USA) in 34 patients (96.1 and 97.1%, respectively; p = 1.00). Major access site bleedings were more frequent in the Amplatzer™ Amulet™ group (8.9 versus 1.4%; p = 0.046). No intra-hospital thromboembolic event was present. During 6 months follow-up, peri-device leaks > 5 mm and thromboembolic events were uncommon (each p = n.s.). CONCLUSIONS: While procedural success was equally high with both contemporary devices, complications during follow-up were rare, and evenly distributed.

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Published by BMC Cardiovascular Disorders · CC BY

Cite This Study

Fastner et al. (2018) conducted an observational in Non-valvular atrial fibrillation with OAC ineligibility (n=189). Amplatzer Amulet vs. Watchman device was evaluated on Thromboembolic event (stroke and systemic embolization) at 6 months (OR 1.22, 95% CI 0.04-30.70, p=1.00). In a real-world registry of patients with non-valvular atrial fibrillation, left atrial appendage closure with the Amplatzer Amulet device showed no significant difference in thromboembolic events at 6 months compared to the Watchman device (0.0% vs 0.9%, OR 1.22).

synapsesocial.com/papers/6ab881cbcf37737d8da12e76 https://doi.org/10.1186/s12872-018-0899-9