Abnormal distortion of aortic corevalve bioprosthesis with suicide left ventricle, aortic insufficiency, and severe mitral regurgitation during transcatheter aortic valve replacement.

We present a patient with critical degenerative aortic stenosis, mitral annular and aortomitral continuity calcification, and senile sigmoid septal hypertrophy who underwent transcatheter aortic valve replacement using the CoreValve bioprosthesis. Immediately after predilation of the aortic valve (18-mm balloon), the patient developed severe hypotension and dynamic left ventricular outflow tract (LVOT) obstruction with systolic anterior motion of the anterior mitral leaflet, causing severe mitral regurgitation. After deployment of a 26-mm bioprosthesis, a transesophageal echocardiogram and left ventriculogram showed that the frame of the bioprosthesis appeared distorted and underexpanded. On the mitral side of the aorta (side of the aortomitral curtain between 12:00 and 3:00, echo short axis view), we found moderate periprosthetic aortic insufficiency with worse mitral regurgitation. The left ventricle was small and hyperdynamic (ejection fraction >85%). The patient soon developed complete heart block, atrial fibrillation, and ventricular tachycardia. She was resuscitated with aggressive intravenous fluids, vasopressors, and an emergently placed atrioventricular sequential pacemaker. We postdilated the 26-mm bioprosthesis with a 22-mm Z-Med balloon and subsequently with a 25-mm balloon. Each balloon was inflated to its nominal volume and pressure and conformed the nitinol frame of the valve to the net circular shape and expected diameter. However, as soon as each balloon was deflated, the surrounding aortic root anatomy visibly recoiled and the frame returned to its smaller diameter with a distorted shape. A second 26-mm CoreValve bioprosthesis was then deployed in a "valve-in-valve" configuration. Soon after, the patient's hemodynamics improved, her clinical condition stabilized, and she completely recovered. © 2016 Wiley Periodicals, Inc.

Results with the Talent thoracic stent graft in the VALOR trial.

OBJECTIVE: We report the 5-year outcomes of thoracic endovascular aneurysm repair (TEVAR) using the Medtronic Vascular Talent Thoracic Stent Graft System (Medtronic Vascular, Santa Rosa, Calif) in patients considered low or moderate risk for open surgical repair. METHODS: The Evaluation of the Medtronic Vascular Talent Thoracic Stent Graft System for the Treatment of Thoracic Aortic Aneurysms (VALOR) trial was a prospective, nonrandomized, multicenter, pivotal study conducted at 38 U.S. sites. Between December 2003 and June 2005, VALOR enrolled 195 patients who were low or moderate risk (0, 1, and 2) per the modified Society for Vascular Surgery and American Association for Vascular Surgery criteria. The patients had fusiform thoracic aortic aneurysms (TAAs) and/or focal saccular TAAs/penetrating atherosclerotic ulcers. Standard follow-up interval examinations were conducted at 1 month, 6 months, 1 year, and annually thereafter. RESULTS: Over the 5-year follow-up, 76 deaths occurred (43.9%). Freedom from all-cause mortality was 83.9% at 1 year and 58.5% at 5 years. Most deaths were due to cardiac, pulmonary or cancer-related causes. Freedom from aneurysm-related mortality (ARM) was 96.9% at 1 year and 96.1% at 5 years. There was only 1 case of ARM after the first year of follow-up. Over the 5-year follow-up period, four patients were converted to open surgery and four patients experienced aneurysm rupture. The 5-year freedom from aneurysm rupture was 97.1% and the 5-year freedom from conversion to surgery was 97.1%. The incidence of stent graft migration (>10 mm) was ≤ 1.8% in each year of follow-up. The rate of type I endoleak was 4.6% at 1 month, 6.3% from 1 month to 1 year, and 3.8% during year 5. The rate of type III endoleak was 1.3% at 1 month, 1.9% from 1 month to 1 year, and 1.9% during year 5. Through 5 years, 28 patients (14.4%) underwent 31 additional endovascular procedures on the original target lesion. The 5-year freedom from secondary endovascular procedures was 81.5%. CONCLUSIONS: Through 5-year follow-up in patients who were candidates for open surgical repair, TEVAR using the Talent Thoracic Stent Graft System has demonstrated sustained protection from ARM, aneurysm rupture, and conversion to surgery, and durable stent graft performance. Close patient follow-up remains essential after TEVAR.

Pivotal results for the Medtronic Valiant Thoracic Stent Graft System in the VALOR II trial.

OBJECTIVE: We report 30-day and 12-month results of endovascular treatment with the Valiant Thoracic Stent Graft System (Medtronic Vascular, Santa Rosa, Calif) in patients with descending thoracic aortic aneurysms of degenerative etiology. The Valiant stent graft is an evolution of the Talent thoracic stent graft (Medtronic Vascular). METHODS: The VALOR II (Evaluation of the Clinical Performance of the Valiant Thoracic Stent Graft System in the Treatment of Descending Thoracic Aneurysms of Degenerative Etiology in Subjects Who Are Candidates for Endovascular Repair) was a prospective, nonrandomized, pivotal trial conducted at 24 U.S. sites with enrollment between December 2006 and September 2009. Standard follow-up examinations, including physical examination, computed tomography, and chest radiography, were at 1, 6, and 12 months, and annually through 5 years. VALOR II outcomes were compared with those from the pivotal VALOR (Evaluation of the Medtronic Vascular Talent Thoracic Stent Graft System for the Treatment of Thoracic Aortic Aneurysms) trial of the Talent stent graft, which enrolled 195 patients with similar enrollment criteria. RESULTS: VALOR II enrolled 160 patients. Compared with VALOR patients, VALOR II patients had similar age and sex distribution but higher rates of cardiovascular risk factors and significantly more severe modified Society for Vascular Surgery/American Association for Vascular Surgery risk scores. Stent graft delivery and deployment were successful in 154 patients (96.3%). Outcomes at 30 days in VALOR II were perioperative mortality, 3.1%; major adverse events, 38.1%; paraplegia, 0.6%; paraparesis, 1.9%; and stroke, 2.5%. At 12 months, after the minimum sample size was reached, 151 patients were evaluated: aneurysm-related mortality was 4.0%, stent graft migration was 2.9%, and endoleak was 13.0%. Through 12 months, there were no ruptures, conversions to open surgery, secondary procedures due to endoleak >30 days, or loss of stent graft patency. The Valiant stent graft was statistically noninferior to the Talent stent graft in 12-month all-cause mortality (12.6% vs 16.1%) and exceeded the primary effectiveness goal of 12-month successful aneurysm treatment, defined as absence of aneurysm growth >5 mm and of secondary procedures for type I/III endoleak (97.4% vs 80.0%). CONCLUSIONS: The VALOR II 12-month results demonstrate that the Medtronic Valiant thoracic stent graft is a safe and effective treatment for patients with descending thoracic aortic aneurysms of degenerative etiology.

Pivotal results of the Medtronic Vascular Talent Thoracic Stent Graft System: the VALOR trial.

OBJECTIVE: This report summarizes the 30-day and 12-month results of endovascular treatment using the Medtronic Vascular Talent Thoracic Stent Graft System (Medtronic Vascular, Santa Rosa, Calif) for patients with thoracic aortic aneurysms (TAA) who are considered candidates for open surgical repair. METHODS: The study was a prospective, nonrandomized, multicenter, pivotal trial conducted at 38 sites. Enrollment occurred between December 2003 and June 2005. Standard follow-up interval examinations were prescribed at 1 month, 6 months, 1 year, and annually thereafter. These endovascular results were compared with retrospective open surgical data from three centers of excellence. RESULTS: The Evaluation of the Medtronic Vascular Talent Thoracic Stent Graft System for the Treatment of Thoracic Aortic Aneurysms (VALOR) trial enrolled 195 patients, and 189 were identified as retrospective open surgical subjects. Compared with the open surgery group, the VALOR test group had similar age and sex distributions, but had a smaller TAA size. Patients received a mean number of 2.7 +/- 1.3 stent graft components. The diameters of 25% of the proximal stent graft components implanted were <26 mm or >40 mm. Left subclavian artery revascularization was performed before the initial stent graft procedure in 5.2% of patients. Iliac conduits were used in 21.1% of patients. In 33.5% of patients, the bare spring segment of the most proximally implanted device was in zones 1 or 2 of the aortic arch. In 194 patients (99.5%), vessel access and stent graft deployment were successful at the intended site. The 30-day VALOR results included perioperative mortality, 2.1%; major adverse advents, 41%; incidence of paraplegia, 1.5%; paraparesis, 7.2%; and stroke, 3.6%. The 12-month VALOR results included all-cause mortality, 16.1%; aneurysm-related mortality, 3.1%; conversion to open surgery, 0.5%; target aneurysm rupture, 0.5%; stent graft migration >10 mm, 3.9%; endoleak (12.2%), stent graft patency, 100%; stable or decreasing aneurysm diameter, 91.5%; and loss of stent graft integrity, four patients. No deployment-related events or perforation of the aorta by a graft component occurred. The Talent Thoracic Stent Graft showed statistically superior performance with respect to acute procedural outcomes (P < .001), 30-day major adverse events (41% vs 84.4%, P < .001), perioperative mortality (2% vs 8%, P < .01), and 12-month aneurysm-related mortality (3.1% vs 11.6%, P < .002) vs open surgery. CONCLUSIONS: The pivotal VALOR 12-month trial results demonstrate that the Medtronic Talent Thoracic Stent Graft System is a safe and effective endovascular therapy as an alternative to open surgery in patients with TAA who were considered candidates for open surgical repair.