Percutaneous left atrial appendage transcatheter occlusion (PLAATO system) to prevent stroke in high-risk patients with non-rheumatic atrial fibrillation: results from the international multi-center feasibility trials.
OBJECTIVE
These studies were conducted to evaluate the feasibility of percutaneous left atrial appendage (LAA) occlusion using the PLAATO system (ev3 Inc., Plymouth, Minnesota).


BACKGROUND
Patients with atrial fibrillation (AF) have a five-fold increased risk for stroke. Other studies have shown that more than 90% of atrial thrombi in patients with non-rheumatic AF originate in the LAA. Transvenous closure of the LAA is a new approach in preventing embolism in these patients.


METHODS
Within two prospective, multi-center trials, LAA occlusion was attempted in 111 patients (age 71 +/- 9 years). All patients had a contraindication for anticoagulation therapy and at least one additional risk factor for stroke. The primary end point was incidence of major adverse events (MAEs), a composite of stroke, cardiac or neurological death, myocardial infarction, and requirement for procedure-related cardiovascular surgery within the first month.


RESULTS
Implantation was successful in 108 of 111 patients (97.3%, 95% confidence interval [CI] 92.3% to 99.4%) who underwent 113 procedures. One patient (0.9%, 95% CI 0.02% to 4.9%) experienced two MAEs within the first 30 days: need for cardiovascular surgery and in-hospital neurological death. Three other patients underwent in-hospital pericardiocentesis due to a hemopericardium. Average follow-up was 9.8 months. Two patients experienced stroke. No migration or mobile thrombus was noted on transesophageal echocardiogram at one and six months after device implantation.


CONCLUSIONS
Closing the LAA using the PLAATO system is feasible and can be performed at acceptable risk. It may become an alternative in patients with AF and a contraindication for lifelong anticoagulation treatment.
CardioVascular Center Frankfurt, Sankt Katharinen, Frankfurt, Germany.
Stefan H
SH
Ostermayer
Mark
M
Reisman
Paul H
PH
Kramer
Ray V
RV
Matthews
William A
WA
Gray
Peter C
PC
Block
Heyder
H
Omran
Antonio L
AL
Bartorelli
Paolo
P
Della Bella
Carlo
C
Di Mario
Carlo
C
Pappone
Paul N
PN
Casale
Jeffrey W
JW
Moses
Athena
A
Poppas
David O
DO
Williams
Bernhard
B
Meier
Allan
A
Skanes
Paul S
PS
Teirstein
Michael D
MD
Lesh
Toshiko
T
Nakai
Yves
Y
Bayard
Kai
K
Billinger
Thomas
T
Trepels
Ulrike
U
Krumsdorf
Horst
H
Sievert
D000368:Aged; D000369:Aged, 80 and over; D000925:Anticoagulants; D020517:Atrial Appendage; D001281:Atrial Fibrillation / Q000150:complications* / Q000628:therapy*; D021721:Balloon Occlusion / Q000295:instrumentation*; D002545:Brain Ischemia / Q000209:etiology / Q000517:prevention & control*; D006328:Cardiac Catheterization / Q000295:instrumentation*; D000075202:Contraindications; D005240:Feasibility Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D011446:Prospective Studies; D020521:Stroke / Q000209:etiology / Q000517:prevention & control*; D016896:Treatment Outcome
D000925:Anticoagulants