Background The National Cardiogenic Shock Initiative is a single‐arm, prospective, multicenter study to assess outcomes associated with early mechanical circulatory support (MCS) in patients presenting with acute myocardial infarction and cardiogenic shock (AMICS) treated with percutaneous coronary intervention (PCI). Methods Between July 2016 and February 2019, 35 sites participated and enrolled into the study. All centers agreed to treat patients with AMICS using a standard protocol emphasizing invasive hemodynamic monitoring and rapid initiation of MCS. Inclusion and exclusion criteria mimicked those of the “SHOCK” trial with an additional exclusion criteria of intra‐aortic balloon pump counter‐pulsation prior to MCS. Results A total of 171 consecutive patients were enrolled. Patients had an average age of 63 years, 77% were male, and 68% were admitted with AMICS. About 83% of patients were on vasopressors or inotropes, 20% had a witnessed out of hospital cardiac arrest, 29% had in‐hospital cardiac arrest, and 10% were under active cardiopulmonary resuscitation during MCS implantation. In accordance with the protocol, 74% of patients had MCS implanted prior to PCI. Right heart catheterization was performed in 92%. About 78% of patients presented with ST‐elevation myocardial infarction with average door to support times of 85 ± 63 min and door to balloon times of 87 ± 58 min. Survival to discharge was 72%. Creatinine ≥2, lactate >4, cardiac power output (CPO) <0.6 W, and age ≥ 70 years were predictors of mortality. Lactate and CPO measurements at 12–24 hr reliably predicted overall mortality postindex procedure. Conclusion In contemporary practice, use of a shock protocol emphasizing best practices is associated with improved outcomes.
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.
CE Mark approval in September 2011 and to date over 100 commercial implants have been performed. The device is composed of a porcine biologic valve attached to a self-expanding nitinol stent designed for simple 2-step implantation and characterized by controlled positioning, self-seating in the native annulus resulting in a negligible paravalvular leak rate. The device was tested in patients at high-risk for mortality with open surgical repair. Methods: Ninety (90) patients (femaleϭ69%) with severe aortic stenosis, a mean age of 83.4 Ϯ 4.1 years, all presenting with NYHA Functional Class III or IV and a mean STS Score of 7.9 Ϯ 4.6 were enrolled in two studies in Germany at 6 centers. Patients are clinically followed at 7 and 30 days, at 6 and 12 months, and annually thereafter out to 5 years post-implant. The device was successfully implanted in 94.4% of patients (nϭ85) with a pacemaker implantation rate of 11.1% (nϭ10). Results: At 12 months the survival rate is 81.1% (nϭ73), the stroke rate is 4.4% (nϭ4), with no further re-intervention required on the implanted device since procedure. Of the returning patients, 87% presented with NYHA Functional Class I/II. The mean gradient at 6 months is 10.3 Ϯ 5.2 mmHg, the mean EOA is 1.5 Ϯ 0.4 cm2 and 77.3% of returning patients suffered no paravalvular leak, 21.2% exhibit mild paravalvular leak (ϩ1) and only 1 patient possesses a moderate paravalvular leak (ϩ2). Conclusions: These data confirm the safety profile at one year of this 2nd Generation TAVI system. We will report the full 12 months results of this multi-center, nonrandomized study of this transapically-placed transcatheter aortic valve at TCT 2012.
A prospective double-blind trial of aspirin prophylaxis demonstrated a reduction of more than 50% in headache frequency in 9 of 12 migraine patients. Response to aspirin did not correlate with age, duration of headache history, family history, or platelet ultrastructure. There is some evidence that response to aspirin is associated with raised platelet aggregation. This pilot study indicates that aspirin is effective in migraine prophylaxis.
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