麻豆传媒

The rate of early adverse events after left atrial appendage (LAA) closure with Amplatzer devices is "non-negligible," an observational study suggested.

Although early procedural success occurred in an impressive 97.8% of patients, major adverse events occurred with the week at a frequency of 5.8%, according to , of University Hospital of Bern in Switzerland, and colleagues.

The predictors of these events were device repositioning (odds ratio 9.13, 95% CI 2.85-33.54) and left ventricular ejection fraction below 30% (OR 4.08, 95% CI 1.49-11.20), they wrote in JACC: Cardiovascular Interventions.

There was no effect of device type or size, nor did LAA morphology have an impact on event rates, they noted.

"Taken together, the findings of the present as well as previous studies suggest non-negligible rates of early safety events and thus point to the potential value of identifying predictive factors of early complications," Gloekler's group wrote.

In an accompanying editorial, , of Rutgers Robert Wood Johnson Medical School in New Brunswick, N.J., called the study "admirable," but said that it does not change the fact that Amplatzer devices still lack the robust evidence base of their main competitor, the Watchman.

While the Watchman has been subjected to two large randomized trials and several prospective registries boasting core laboratories and independent clinical events committees, the Amplatzer dataset is just based on "registries, mostly retrospective, and most without clinical events committees, core laboratories, independent data oversight, or data safety monitoring boards," Turi noted.

Thus, he emphasized a need for those missing randomized trials.

In the current multi-center study, 500 consecutive patients received either the Amplatzer Cardiac Plug (82%) or Amulet (18%) for stroke prevention. All had atrial fibrillation and were high-risk for oral anticoagulation.

Half the LAA closures were performed in conjunction with other interventions, namely percutaneous coronary intervention, patent foramen ovale occlusion, transcatheter aortic valve replacement, mitral clip insertion, or atrial fibrillation ablation.

"From a clinical standpoint, the benefits of 'drive-by' LAA closure can be debated: patients benefit from fewer and more comprehensive procedures; at the same time, contrast load, fluoroscopy, and procedure times are increased," Turi commented.

The authors recognized that they may have overestimated their LAA closure rate, lacking any periprocedural transesophageal echocardiographic assessment. In line with Turi's general observation of Amplatzer studies, there was also no independent monitoring or core laboratory analysis in the retrospective investigation.

Furthermore, the centers have been performing the LAA closures since 2002, their experience limiting the generalizability of the findings to other institutions.

This may make the 5.8% event rate even more worrying, according to Turi.

"The complication rate in this study is difficult to interpret but is arguably higher than one might have expected: the authors have exceptional experience and therefore are well past the usual learning curve. Thus they would be expected to have an unusually low rate of adverse events: in this study of 500 patients there were 10 embolizations and 33 pericardial effusions, of which 16 are described as major," he wrote.

He advocated for the use of routine echocardiographic guidance for now.

"Going forward, there continues to be a need for randomized trials of the [Amplatzer], and, more importantly, for a high level evidence base that examines LAA closure without post-implantation anticoagulation," Turi urged.