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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.

The aim of this study was to evaluate the performance of an adjusted HeartMate II risk score (HMRS) in Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS; n = 9,733) and in HeartWare Ventricular Assist Device (HVAD) bridge to transplant (BTT) trial patients (n = 360). Interagency Registry for Mechanically Assisted Circulatory Support data were used to calculate an adjusted HMRS, omitting center volume, for all patients on continuous-flow left ventricular assist device (LVAD) support. Ninety day mortality was then evaluated in INTERMACS and HVAD-BTT patients. Four risk groups were identified based on INTERMACS patient-adjusted HMRS: very low (<5%, 90 day mortality; score <0.20), low (5-10%, 90 day mortality; score 0.20-1.97), medium (10-20%, 90 day mortality; score 1.98-4.48), and high risk (>20%, 90 day mortality; score >4.48). Within INTERMACS, there were significant differences in survival between all-adjusted HMRS risk groups (p < 0.001 in pairwise comparisons). Controlling for known mortality correlates, the adjusted HMRS mortality hazard ratio was 1.19 (1.25-1.23) per unit HMRS increase. The HVAD cohort was a low-risk cohort with 90 day survivals for very low-, low-, and medium-risk patients of 100%, 97 ± 1.1%, and 90 ± 3.6%, respectively (p = 0.007). Patients in the very low- and low-risk group had significantly improved survival compared with medium-risk patients, respectively (both p < 0.05). The adjusted HMRS appropriately risk stratified a large cohort of INTERMACS patients and was predictive of survival in HeartWare-supported patients.

Objective: We evaluated a large single center experience of endograft repair of blunt traumatic injury of the thoracic aorta., Summary Background Data: Traumatic aortic transection is a devastating injury with high morbidity and mortality. Endograft repair of these injuries has reduced the rates of death and paraplegia seen with open surgical treatment in the past. However, endograft repair has been associated with a higher incidence of device related failure., Methods: The records of 43 consecutive cases of endograft treatment of traumatic aortic injury from December 2004 to November 2008 were reviewed. Patient demographics, procedure details, and outcomes were recorded. Aortic morphology was analyzed for predictors of device failure., Results: Forty-three patients (32 men) with a mean age of 44 years (range: 17-88) were treated. Primary technical success was 86%. Six proximal endoleaks (14.3%) occurred. Two were repaired with a more proximal cuff, but 3 required explantation and open repair (7%). Mortality in this series was 11.6%, but no death was aorta related. No patient having endograft treatment suffered postoperative paraplegia. Early device failure is associated with sharp angulation of the aorta and shortened distance between the left subclavian artery and the site of injury. Follow-up ranged from 1 to 38 months (mean: 7.4 months). There were no late device failures or complications., Conclusions: Endovascular repair of blunt traumatic aortic injury can be performed with a low morbidity and mortality. Anatomic patterns in the aortic arch appear to be predictive of early device failure. Midterm durability is excellent, but reliable follow-up remains challenging in this group of patients.