Citations 2
Pivotal Clinical Study to Evaluate the Safety and Effectiveness of the MANTA Percutaneous Vascular Closure Device
Wood, David , Krajcer, Zvonimir , Sathananthan, Janarthanan , Strickman, Neil E., Metzger, Chris, Fearon, William F. , Aziz, Mark, Satler, Lowell F. , Waksman, Ron , Eng, Marvin H. , Heimansohn, David, Sampson, Andrew, Coady, Paul , Rodriguez, Roberto , Krishnaswamy, Amar , Lee, Jason T. , Ben‐Dor, Itsik , Moainie, Sina L. , Kodali, Susheel , Yadav, Pradeep , Kozak, Mark, Bacharach, J. Michael, Feldman, Ted , Nanjundappa, Aravinda , Bersin, Robert M., Potluri, Srinivasa , Barker, Colin M. , Bernardo, Nelson L. , Lumsden, Alan B. , Dake, Michael D. , Brown, David L. , Maor, Nathaniel, Nardone, Samuel, Webb, John G. , Investigators, on behalf of the SAFE MANTA Study, Kapadia, Samir , Greenbaum, Adam B. , Szerlip, Molly , Chhatriwalla, Adnan K , O’Neill, Brian Patrick , Guerrero, Mayra , Zhang, Ming , Barleben, Andrew R. , Campbell, John , Cohen, David Jonathan , Lauck, Sandra , O’Neill, William W. , Investigators, on behalf of the SAFE MANTA Study
Circulation: Cardiovascular Interventions | July 12, 2019 | Volume: 12 | Issue: 7 | Pages: No page available
10.1161/circinterventions.119.007258
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.
Refractory Pulmonary Edema and Upper Body Hypoxemia During Veno‐Arterial Extracorporeal Membrane Oxygenation—A Case for Atrial Septostomy
Prasad, Amit , Ghodsizad, Ali , Kozak, Mark, Körner, Michael, Banayosy, Aly El, Singbartl, Kai , Singbartl, Kai , Brehm, Christoph E
Artificial Organs | January 18, 2018 | Volume: 42 | Issue: 6 | Pages: 664-669
AbstractVeno‐arterial extracorporeal membrane oxygenation (VA‐ECMO) provides mechanical circulatory support for patients with advanced cardiogenic shock, facilitating myocardial recovery and limiting multi‐organ failure. In patients with severely limited left ventricular ejection, peripheral VA‐ECMO can further increase left ventricular and left atrial pressures (LAP). Failure to decompress the left heart under these circumstances can result in pulmonary edema and upper body hypoxemia, that is, myocardial and cerebral ischemia. Atrial septostomy can decrease LAP in these situations. However, the effects of atrial septostomy on upper body oxygenation remain unknown. After IRB approval, we identified 9 out of 242 adult VA‐ECMO patients between January 2011 and June 2016 who also underwent atrial septostomy for refractory pulmonary edema/upper body hypoxemia. We analyzed LAP/pulmonary capillary wedge pressure (PCWP), right atrial pressures (RAPs), PaO2/FiO2 ratios (blood samples from right radial artery), intrathoracic volume status, and resolution of pulmonary edema before and up to 48 h after septostomy. There were no procedure‐related complications. Thirty‐day survival was 44%. LAP/PCWP decreased by approximately 40% immediately following septostomy and remained so for at least 24 h. PaO2/FiO2 ratios significantly increased from 0.49 (0.38–2.12) before to 5.35 (3.01–7.69) immediately after septostomy and continued so for 24 h, 6.6 (4.49–10.93). Radiographic measurements also indicated a significant improvement in thoracic intravascular volume status after atrial septostomy. Atrial septostomy reduces LAP and improves upper body oxygenation and intrathoracic vascular volume status in patients developing severe refractory pulmonary edema while undergoing peripheral VA‐ECMO. Atrial septostomy therefore appears safe and suitable to reduce the risk of upper body ischemia under these circumstances.