Author + information
- Received January 15, 2019
- Revision received April 2, 2019
- Accepted April 11, 2019
- Published online June 3, 2019.
- Jens Erik Nielsen-Kudsk, MD, DMSca,∗ (, )
- Sergio Berti, MDb,
- Ole De Backer, MD, PhDc,
- Daniel Aguirre, MDd,
- Gaetano Fassini, MDe,
- Ignacio Cruz-Gonzalez, MD, PhDf,
- Giuseppi Grassi, MDg and
- Claudio Tondo, MD, PhDe
- aAarhus University Hospital, Aarhus, DenmarkaAarhus University Hospital, Aarhus, Denmark
- bFondazione Toscana Gabriele Monasterio, Massa, ItalyFondazione Toscana Gabriele Monasterio, Massa, Italy
- cRigshospitalet, Copenhagen, DenmarkRigshospitalet, Copenhagen, Denmark
- dHospital Clinico San Borja Arriaran, Santiago, ChileHospital Clinico San Borja Arriaran, Santiago, Chile
- eHeart Rhythm Center at Monzino Cardiac Center, University of Milan, Milan, ItalyHeart Rhythm Center at Monzino Cardiac Center, University of Milan, Milan, Italy
- fUniversitario de Salamanca, Salamanca, SpainUniversitario de Salamanca, Salamanca, Spain
- gOspedale dell’Angelo, Venice, ItalyOspedale dell’Angelo, Venice, Italy
- ↵∗Address for correspondence:
Prof. Jens Erik Nielsen-Kudsk, Department of Cardiology, Aarhus University Hospital, Skejby, Palle Juul-Jensens Boulevard 99, DK-8200 Aarhus N, Denmark.
Objectives The aim of this study was to compare patient and procedural characteristics, clinical events, and left atrial appendage (LAA) occlusion rates among implantation procedures guided either by intracardiac echocardiography (ICE) or by transesophageal echocardiography (TEE) in the Amulet Observational Study.
Background TEE is standard for intraprocedural imaging during LAA occlusion. ICE is an alternative enabling local rather than general anesthesia.
Methods The Amulet Observational Study is a prospective, multicenter, post-market study of the Amulet device in patients with atrial fibrillation at risk for thromboembolism from the LAA. Procedures were guided by ICE in the left atrium or TEE. A clinical events committee adjudicated serious adverse events. LAA closure was assessed by a core laboratory 1 to 3 months post-implantation.
Results Nine hundred fifty-five procedures were TEE guided and 130 (12%) were ICE guided. Local anesthesia was used in 93% of ICE-guided cases. Implantation success was >99% in both groups (p = 1.00). The procedure was longer (40 ± 31 min vs. 33 ± 21 min; p = 0.01) and contrast use higher (145 ± 157 ml vs. 98 ± 76 ml; p < 0.01) for ICE cases. LAA closure rate was 100% using ICE and 98% using TEE. Vascular access serious adverse events occurred in 0.8% of ICE patients and 1.5% of TEE patients (p = 0.52). Pericardial effusions or tamponade was observed at rates of 2.5% per year and 1.7% per year in ICE and TEE patients, respectively (p = 0.57). Rates of ischemic stroke (4.1% per year vs. 2.6% per year; p = 0.37) and major bleeding (8.2% per year vs. 10.6% per year; p = 0.44) did not differ significantly between ICE and TEE patients.
Conclusions Amulet LAA occlusion procedures guided by ICE and TEE resulted in comparable clinical event and LAA closure rates, without differences in procedural or vascular complications despite longer procedures and more contrast use.
Abbott provided funding for the Amulet Observational Study. No funding was provided for this analysis. Dr. Nielsen-Kudsk is a consultant and proctor for Abbott. Dr. Berti is a proctor for Abbott. Dr. De Backer has been a consultant for Abbott. Dr. Cruz-Gonzalez is a proctor for Abbott and Boston Scientific. Dr. Tondo is a consultant for Abbott. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received January 15, 2019.
- Revision received April 2, 2019.
- Accepted April 11, 2019.
- 2019 American College of Cardiology Foundation
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