TY - JOUR
T1 - Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the MANTA Percutaneous Vascular Closure Device
T2 - The SAFE MANTA Study
AU - Wood, David A.
AU - Krajcer, Zvonimir
AU - Sathananthan, Janarthanan
AU - Strickman, Neil
AU - Metzger, Chris
AU - Fearon, William
AU - Aziz, Mark
AU - Satler, Lowell F.
AU - Waksman, Ron
AU - Eng, Marvin
AU - Kapadia, Samir
AU - Greenbaum, Adam
AU - Szerlip, Molly
AU - Heimansohn, David
AU - Sampson, Andrew
AU - Coady, Paul
AU - Rodriguez, Roberto
AU - Krishnaswamy, Amar
AU - Lee, Jason T.
AU - Ben-Dor, Itsik
AU - Moainie, Sina
AU - Kodali, Susheel
AU - Chhatriwalla, Adnan K.
AU - Yadav, Pradeep
AU - O'Neill, Brian
AU - Kozak, Mark
AU - Bacharach, John M.
AU - Feldman, Ted
AU - Guerrero, Mayra
AU - Nanjundappa, Aravinda
AU - Bersin, Robert
AU - Zhang, Ming
AU - Potluri, Srinivasa
AU - Barker, Colin
AU - Bernardo, Nelson
AU - Lumsden, Alan
AU - Barleben, Andrew
AU - Campbell, John
AU - Cohen, David J.
AU - Dake, Michael
AU - Brown, David
AU - Maor, Nathaniel
AU - Nardone, Samuel
AU - Lauck, Sandra
AU - O'Neill, William W.
AU - Webb, John G.
N1 - Publisher Copyright:
© 2019 American Heart Association, Inc.
PY - 2019/7/1
Y1 - 2019/7/1
N2 - Background: Open surgical closure and small-bore suture-based preclosure devices have limitations when used for transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, or percutaneous thoracic endovascular aortic aneurysm repair. The MANTA vascular closure device is a novel collagen-based technology designed to close large bore arteriotomies created by devices with an outer diameter ranging from 12F to 25F. In this study, we determined the safety and effectiveness of the MANTA vascular closure device. Methods and Results: A prospective, single arm, multicenter investigation in patients undergoing transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, or thoracic endovascular aortic aneurysm repair at 20 sites in North America. The primary outcome was time to hemostasis. The primary safety outcomes were accessed site-related vascular injury or bleeding complications. A total of 341 patients, 78 roll-in, and 263 in the primary analysis cohort, were entered in the study between November 2016 and September 2017. For the primary analysis cohort, transcatheter aortic valve replacement was performed in 210 (79.8%), and percutaneous endovascular abdominal aortic aneurysm repair or thoracic endovascular aortic aneurysm repair was performed in 53 (20.2%). The 14F MANTA was used in 42 cases (16%), and the 18F was used in 221 cases(84%). The mean effective sheath outer diameter was 22F (7.3 mm). The mean time to hemostasis was 65±157 seconds with a median time to hemostasis of 24 seconds. Technical success was achieved in 257 (97.7%) patients, and a single device was deployed in 262 (99.6%) of cases. Valve Academic Research Consortium-2 major vascular complications occurred in 11 (4.2%) cases: 4 received a covered stent (1.5%), 3 had access site bleeding (1.1%), 2 underwent surgical repair (0.8%), and 2 underwent balloon inflation (0.8%). Conclusions: In a selected population, this study demonstrated that the MANTA percutaneous vascular closure device can safely and effectively close large bore arteriotomies created by current generation transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, and thoracic endovascular aortic aneurysm repair devices. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02908880.
AB - Background: Open surgical closure and small-bore suture-based preclosure devices have limitations when used for transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, or percutaneous thoracic endovascular aortic aneurysm repair. The MANTA vascular closure device is a novel collagen-based technology designed to close large bore arteriotomies created by devices with an outer diameter ranging from 12F to 25F. In this study, we determined the safety and effectiveness of the MANTA vascular closure device. Methods and Results: A prospective, single arm, multicenter investigation in patients undergoing transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, or thoracic endovascular aortic aneurysm repair at 20 sites in North America. The primary outcome was time to hemostasis. The primary safety outcomes were accessed site-related vascular injury or bleeding complications. A total of 341 patients, 78 roll-in, and 263 in the primary analysis cohort, were entered in the study between November 2016 and September 2017. For the primary analysis cohort, transcatheter aortic valve replacement was performed in 210 (79.8%), and percutaneous endovascular abdominal aortic aneurysm repair or thoracic endovascular aortic aneurysm repair was performed in 53 (20.2%). The 14F MANTA was used in 42 cases (16%), and the 18F was used in 221 cases(84%). The mean effective sheath outer diameter was 22F (7.3 mm). The mean time to hemostasis was 65±157 seconds with a median time to hemostasis of 24 seconds. Technical success was achieved in 257 (97.7%) patients, and a single device was deployed in 262 (99.6%) of cases. Valve Academic Research Consortium-2 major vascular complications occurred in 11 (4.2%) cases: 4 received a covered stent (1.5%), 3 had access site bleeding (1.1%), 2 underwent surgical repair (0.8%), and 2 underwent balloon inflation (0.8%). Conclusions: In a selected population, this study demonstrated that the MANTA percutaneous vascular closure device can safely and effectively close large bore arteriotomies created by current generation transcatheter aortic valve replacement, percutaneous endovascular abdominal aortic aneurysm repair, and thoracic endovascular aortic aneurysm repair devices. Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02908880.
KW - blood transfusion
KW - hemostasis
KW - stent
KW - transcatheter aortic valve replacement
KW - vascular closure device
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U2 - 10.1161/CIRCINTERVENTIONS.119.007258
DO - 10.1161/CIRCINTERVENTIONS.119.007258
M3 - Article
C2 - 31296082
AN - SCOPUS:85069752037
SN - 1941-7640
VL - 12
JO - Circulation: Cardiovascular Interventions
JF - Circulation: Cardiovascular Interventions
IS - 7
M1 - e007258
ER -