RESUMEN
PURPOSE OF THE STUDY: To evaluate the mid-term safety and effectiveness of a novel stent graft for treatment of abdominal aortic aneurysm (AAA). METHODS: Thirty-three patients with AAA (20 males and 13 females; mean age: 71.3 y) were treated with the Ovation™ Abdominal Stent Graft System (TriVascular, Inc., Santa Rosa, CA, USA). Indications for endovascular aneurysm repair: AAA ≥ 5.5 cm, neck ≥ 7 mm, angulation ≤ 60° and with an inner wall diameter of no less than 16 mm and no greater than 30 mm; the presence of neck calcification and thrombosis is not much of a problem in this device because aortic seal is achieved with 2 polymer-filled sealing rings and the fixation by means of a suprarenal stent with 8 pairs of anchors. Patients were followed through discharge and returned for follow-up visits. The follow-up protocol included a CT-A exam at 1 and 12 months after the intervention; the mid-term follow up was performed at 3 and 6 months with contrast-enhanced ultrasound (CEUS). Mean follow-up duration was 18.6 months (range: 3-25 months). MAIN FINDINGS: Technical success was 100%. Mean implantation procedure time was 31.1 minutes, and median hospital stay was 4.6 days. None of the patients required conversion to open surgery, and no aneurysm enlargement, rupture, fracture, or migration were observed. No type I, III or IV endoleaks were observed. Hospitalization death rate was 0%. Death rate at 30 days was 0%. No major complications were observed. CONCLUSIONS: The first results from this 3-center study with the Ovation stent graft are promising with high technical success and excellent safety and effectiveness.
Asunto(s)
Aneurisma de la Aorta Abdominal/cirugía , Implantación de Prótesis Vascular/instrumentación , Prótesis Vascular , Polímeros/uso terapéutico , Anciano , Aneurisma de la Aorta Abdominal/diagnóstico por imagen , Implantación de Prótesis Vascular/efectos adversos , Implantación de Prótesis Vascular/métodos , Femenino , Humanos , Masculino , Polímeros/química , Tomografía Computarizada por Rayos XRESUMEN
The rate responsiveness of a single chamber, accelerometer-based pacemaker with an autocalibration function (Opus G VVIR pacemaker, ELA Medical) was studied with a daily life protocol developed to automatically optimize the programming of accelerometer-based sensors. This new sensor was compared with two other body activity sensors that were manually optimized patient by patient. Forty-three pacemaker recipients (mean age 71 +/- 11 years), paced > 95% of the time, underwent a daily life protocol consisting of rapid walking for 6 minutes (W), climbing upstairs for 1.5 minutes (U), and downstairs for 1.5 minutes (D), alternated by recovery phases. The results were compared with performances measured in a control population of healthy subjects and in two paced patient populations (one equipped with a Dash Intermedics VVIR pacemaker and the other equipped with a Sensolog III Pacesetter/St. Jude VVIR pacemaker). Sex distribution and mean age between paced patients and control subjects were statistically comparable. The mean heartrate achieved by all paced patients at each time sample was compared with the normograms, assigning acceleration (slope) and rate (rate) scores for exercise and recovery phases. Scores ranged from -10 (hypochronotropic) to +10 (hyperchronotropic). Zero represents exact concordance with the responses of healthy individuals, and values between -2.5 and +2.5 were considered statistically similar to normal. During W, although the overall performances of the Dash, Sensolog, and Opus G did not statistically differ from healthy controls, the scores obtained by the Opus G were significantly closer to controls than those of the two other pacemakers (P = 0.02). For U, the three sensors were hypochronotropic (P = 0.03), though the Opus G was associated with a heart rate response closer to that of healthy controls (P = 0.04). D provided similar mean heart rate scores for the Opus G and the Dash compared with healthy controls, in contrast with the hyperchronotropic behavior of the Sensolog (P = 0.02). Opus G revealed a physiological modulation of the heart rate for W and D tests with a slightly hypochronotropic behavior during U. The Opus G autocalibration function provided daily life performances closer to those of healthy controls than two other pacemakers equipped with a body activity sensor that were manually optimized.