TY - JOUR
T1 - Safety and feasibility of peri-device leakage closure after LAAO
T2 - an international, multicentre collaborative study
AU - Piayda, Kerstin
AU - Sievert, Kolja
AU - Della Rocca, Domenico G
AU - Adeola, Oluwaseun G
AU - Alkhouli, Mohamad
AU - Yoo, David
AU - Benito-González, Tomas
AU - Cruz-González, Ignatio
AU - Galea, Roberto
AU - Skurk, Carsten
AU - De Backer, Ole
AU - Nielsen-Kudsk, Jens Erik
AU - Grygier, Marek
AU - Beaty, Elijah H
AU - Newton, Jim
AU - Pérez de Prado, Armando
AU - Räber, Lorenz
AU - Gibson, Douglas
AU - Van Niekerk, Christoffel
AU - Ellis, Christopher R
AU - Horton, Rodney P
AU - Natale, Andrea
AU - Grundwald, Iris
AU - Zeus, Tobias
AU - Sievert, Horst
PY - 2021/12/17
Y1 - 2021/12/17
N2 - BACKGROUND: Residual peri-device leakage (PDL) is frequent after left atrial appendage occlusion (LAAO). Little is known about management strategies, procedural aspects and outcomes of interventional PDL closure.AIMS: The aim of this study was to assess the safety and feasibility of PDL closure after LAAO.METHODS: Fifteen centres contributed data on baseline characteristics, in-hospital and follow-up outcomes of patients who underwent PDL closure after LAAO. Outcomes of interest included acute success and complication rates and long-term efficacy of the procedure.RESULTS: A total of 95 patients were included and a cumulative number of 104 leaks were closed. The majority of PDLs were detected within 90 days (range 41-231). Detachable coils were the most frequent approach (42.3%), followed by the use of the AMPLATZER Vascular Plug II (29.8%) and the AMPLATZER Duct Occluder II (17.3%). Technical success was 100% with 94.2% of devices placed successfully within the first attempt. There were no major complications requiring surgical or transcatheter interventions. During follow-up (96 days [range 49-526]), persistent leaks were found in 18 patients (18.9%), yielding a functional success rate of 82.7%, although PDLs were significantly reduced in size (pre-leak sizemax: 6.1±3.6 mm vs post-leak sizemax: 2.5±1.3 mm, p<0.001). None of the patients had a leak >5 mm. Major adverse events during follow-up occurred in 5 patients (2 ischaemic strokes, 2 intracranial haemorrhages, and 1 major gastrointestinal bleeding).CONCLUSIONS: Several interventional techniques have become available to achieve PDL closure. They are associated with high technical and functional success and low complication rates.
AB - BACKGROUND: Residual peri-device leakage (PDL) is frequent after left atrial appendage occlusion (LAAO). Little is known about management strategies, procedural aspects and outcomes of interventional PDL closure.AIMS: The aim of this study was to assess the safety and feasibility of PDL closure after LAAO.METHODS: Fifteen centres contributed data on baseline characteristics, in-hospital and follow-up outcomes of patients who underwent PDL closure after LAAO. Outcomes of interest included acute success and complication rates and long-term efficacy of the procedure.RESULTS: A total of 95 patients were included and a cumulative number of 104 leaks were closed. The majority of PDLs were detected within 90 days (range 41-231). Detachable coils were the most frequent approach (42.3%), followed by the use of the AMPLATZER Vascular Plug II (29.8%) and the AMPLATZER Duct Occluder II (17.3%). Technical success was 100% with 94.2% of devices placed successfully within the first attempt. There were no major complications requiring surgical or transcatheter interventions. During follow-up (96 days [range 49-526]), persistent leaks were found in 18 patients (18.9%), yielding a functional success rate of 82.7%, although PDLs were significantly reduced in size (pre-leak sizemax: 6.1±3.6 mm vs post-leak sizemax: 2.5±1.3 mm, p<0.001). None of the patients had a leak >5 mm. Major adverse events during follow-up occurred in 5 patients (2 ischaemic strokes, 2 intracranial haemorrhages, and 1 major gastrointestinal bleeding).CONCLUSIONS: Several interventional techniques have become available to achieve PDL closure. They are associated with high technical and functional success and low complication rates.
KW - Feasibility Studies
KW - Humans
KW - Septal Occluder Device/adverse effects
UR - http://www.scopus.com/inward/record.url?scp=85122073326&partnerID=8YFLogxK
U2 - 10.4244/EIJ-D-21-00286
DO - 10.4244/EIJ-D-21-00286
M3 - Journal article
C2 - 34219662
SN - 1774-024X
VL - 17
SP - e1033-e1040
JO - EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
JF - EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
IS - 12
ER -