Maintaining the minimal invasiveness of the percutaneous approach to aortic endografting reduces patient discomfort and permits earlier ambulation and hospital discharge. Initial success seems to be maintained at 1 month, however, longer follow-up will be required.

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 development of segmental or generalized left ventricular hypokinesia is an unusual occurrence in patients with hypertrophic cardiomyopathy. To determine the incidence and possible pathophysiologic mechanisms responsible for this process, the serial clinical and laboratory data of 62 patients with the diagnosis of hypertrophic cardiomyopathy were analyzed. During a mean follow-up period of 8 years (range 2 to 21), 5 patients (Group A) developed left ventricular hypokinesia, whereas the remaining 57 patients (Group B) continued to exhibit the clinical and laboratory findings of hypertrophic cardiomyopathy. Three patients developed a dilated left ventricle with generalized hypokinesia; two other patients had segmental left ventricular wall motion abnormalities. None of these five patients who developed left ventricular hypokinesia had fixed coronary artery disease. The mean age, sex, mean duration of follow-up, presence of coronary myocardial bridges and angina pectoris, and an interventricular gradient were all similar in Groups A and B. Midventricular obliteration was seen in 4 (80%) of the 5 patients in Group A and in 4 (7%) of the 57 patients in Group B (p less than 0.001). Findings from this study reveal that segmental or generalized left ventricular hypokinesia can develop in patients with hypertrophic cardiomyopathy in the absence of fixed coronary artery disease. Such hypokinesia can occur after an acute myocardial infarction or it can develop gradually without clinical or electrocardiographic evidence of infarction. Patients with the mid-ventricular obliteration variant of hypertrophic cardiomyopathy are at a higher risk of developing segmental or diffuse left ventricular hypokinesia.

Endovascular exclusion of abdominal aortic aneurysms (AAAs) was developed in an effort to treat patients who were at high risk for complications following standard surgical repair. Stent grafts used for endovascular repair of AAAs require the use of large-bore sheaths and surgical exposure of the common femoral arteries (CFAs). To decrease the invasiveness of AAA repair, we attempted to perform the procedure percutaneously utilizing the Prostar XL Percutaneous Vascular Surgery Device and the preclose technique. Thirty patients underwent an attempted percutaneous AAA repair. These patients were followed prospectively to assess the success of the procedure. Twenty-eight patients (93%) had successful percutaneous repair of both CFA access sites. One patient had inadequate hemostasis of the 22 Fr CFA entry site and one patient had inadequate hemostasis of the 16 Fr CFA entry site. Both of these CFA sites underwent open surgical repair. The rate of successful repair of the 22 Fr CFA access site was 29 of 30 (96%); for the 16 Fr CFA access site, 29 of 30 (96%). No in-hospital groin complications were seen. The procedure time was 105 +/- 21 min. The estimated blood loss was 90.6 +/- 50 cc. The hemoglobin loss was 1.54 +/- 0.89 mg/dL and the hematocrit loss was 5.04% +/- 2.8%. Complete percutaneous endoluminal AAA repair is feasible using the preclose technique. CFAs with sheaths up to 22 Fr can be safely and successfully accessed and repaired percutaneously using this technique. This method provides secure hemostasis and reduces the invasiveness of procedures requiring large-bore sheaths.

The Wallgraft Endoprosthesis for the treatment of traumatic arterial injuries offers a promising alternative to conventional operative repair with comparable patency and less major morbidity and mortality.