TY - JOUR
T1 - Safety and efficacy of the Amplatzer™ Trevisio™ intravascular delivery system
T2 - Post-approval study results
AU - Hascoet, Sebastien
AU - Baruteau, Alban Elouen
AU - Jalal, Zakaria
AU - Demkow, Marcin
AU - de Winter, Robbert
AU - Gaio, Gianpiero
AU - Clerc, Jean Michel
AU - Sabiniewicz, Robert
AU - Eberli, Franz
AU - Santoro, Giuseppe
AU - Dauphin, Claire
AU - Schubert, Stephan
AU - Smolka, Grzegorz
AU - Lutz, Matthias
AU - Moreno, Raul
AU - Pan, Manuel
AU - Gutierrez-Larraya, Federico
AU - Godart, Francois
AU - Carminati, Mario
AU - Ovaert, Caroline
AU - Batteux, Clement
AU - Guerin, Patrice
AU - Thambo, Jean Benoit
AU - Ewert, Peter
N1 - Publisher Copyright:
© 2023 Abbott Laboratories
PY - 2023/12
Y1 - 2023/12
N2 - Background: The Amplatzer™ Trevisio™ Intravascular Delivery System (Trevisio DS; Abbott Laboratories, Chicago, IL, USA) facilitates the delivery of Amplatzer™ Occluders and features an ultraflexible tip, which improves assessment of occluder position before release. Aims: To assess the safety and efficacy of the Trevisio DS for transcatheter closure of patent foramen ovale and atrial septal defect. Methods: The Amplatzer™ Trevisio™ Intravascular Delivery System Post-Approval Study was a prospective, postmarket, single-arm, multicentre, observational study of the Trevisio DS. Enrolled patients were indicated for transcatheter closure of patent foramen ovale or atrial septal defect. In all procedures, the Trevisio DS was used to deliver Amplatzer™ Occluders. Technical success was defined as successful deployment and release of at least one occluder. Device- or procedure-related serious adverse events were tracked until discharge or day 7, whichever occurred earlier. Results: The study enrolled 144 patients with patent foramen ovale and 107 patients with atrial septal defect at 22 European sites; 53 patients with atrial septal defect (49.6%) were aged < 18 years. The rate of technical success was 98.4% (97.2% for atrial septal defect, 99.3% for patent foramen ovale). There was one serious adverse event (0.4%), an acute periprocedural device embolization that occurred after occluder release in a patient with atrial septal defect; the device was retrieved percutaneously. This was determined by the implanter to be unrelated to the performance of the Trevisio DS. Conclusions: The Trevisio DS exhibited a high rate of technical success and an excellent safety profile during transcatheter closure of patent foramen ovale and atrial septal defect.
AB - Background: The Amplatzer™ Trevisio™ Intravascular Delivery System (Trevisio DS; Abbott Laboratories, Chicago, IL, USA) facilitates the delivery of Amplatzer™ Occluders and features an ultraflexible tip, which improves assessment of occluder position before release. Aims: To assess the safety and efficacy of the Trevisio DS for transcatheter closure of patent foramen ovale and atrial septal defect. Methods: The Amplatzer™ Trevisio™ Intravascular Delivery System Post-Approval Study was a prospective, postmarket, single-arm, multicentre, observational study of the Trevisio DS. Enrolled patients were indicated for transcatheter closure of patent foramen ovale or atrial septal defect. In all procedures, the Trevisio DS was used to deliver Amplatzer™ Occluders. Technical success was defined as successful deployment and release of at least one occluder. Device- or procedure-related serious adverse events were tracked until discharge or day 7, whichever occurred earlier. Results: The study enrolled 144 patients with patent foramen ovale and 107 patients with atrial septal defect at 22 European sites; 53 patients with atrial septal defect (49.6%) were aged < 18 years. The rate of technical success was 98.4% (97.2% for atrial septal defect, 99.3% for patent foramen ovale). There was one serious adverse event (0.4%), an acute periprocedural device embolization that occurred after occluder release in a patient with atrial septal defect; the device was retrieved percutaneously. This was determined by the implanter to be unrelated to the performance of the Trevisio DS. Conclusions: The Trevisio DS exhibited a high rate of technical success and an excellent safety profile during transcatheter closure of patent foramen ovale and atrial septal defect.
KW - Atrial septal defect
KW - Clinical trial
KW - Patent foramen ovale
KW - Septal occluder device
KW - Treatment outcome
UR - http://www.scopus.com/inward/record.url?scp=85176406219&partnerID=8YFLogxK
U2 - 10.1016/j.acvd.2023.10.006
DO - 10.1016/j.acvd.2023.10.006
M3 - Article
AN - SCOPUS:85176406219
SN - 1875-2136
VL - 116
SP - 580
EP - 589
JO - Archives of Cardiovascular Diseases
JF - Archives of Cardiovascular Diseases
IS - 12
ER -