Endurant implanted (826/829)Endurant not implanted in 3 patients:Subject 05001-018: Implanting physician could not get device through iliac system,iliac arteries calcified circumferentially and tortuous. Diameter Left iliac: 13mm (Right iliac: 18mm) Subject 10201-009: One pin remained under the cap. System could not be deployed or retracted. Pt. converted. This was 1st generation spindle design.Medtronic has made improvements to the spindle edges to make them smoother and much less prone to getting caught up.Subject 10312-15 had an implant attempt, but was not implanted with the Endurant device. This patient is a 62 yr old Male patient (152cm and 44kg) with a maximum AAA diameter of 48 mm. Investigator narrative: ‘Patient 10312-015 was a complex problem. This patient needed to undergo the index procedure on a short term. For that reason we used some devices from our own stock. We first placed the iliac extension, with the idea of placing the main body here after through this extension. Eventually this failed and the main body ended up too high in the aorta, and covered both renal arteries. This case is an estimation- and/or measurement error’. During the procedure it was decided to convert the case to open surgery.Patients were converted to open surgery
Transcript of "AHA: Endurant veith 2010"
37th Annual VEITH Symposium 2010 <br />Contemporary One year EVAR Outcomes from the US IDE trial and ENGAGE Global Registry of the Endurant AAA Endograft Device<br />Michel S. Makaroun MD<br />Division of Vascular Surgery<br />University of Pittsburgh<br />for the US Endurant Pivotal Trial Investigators<br />
The Bifurcated Endurant EndoGraft<br />Description<br />Modular Stent-Graft<br />Multi-filament Polyester Fabric<br />Electropolished Nitinol Stent<br />Active Suprarenal fixation <br />3 cm Overlap Zone<br />Pt-Ir and Gold Markers<br /> Endurant<br />
The Bifurcated Endurant EndoGraft<br /><ul><li>M-shaped proximal stent: good neck conformability
One-piece, laser-cut, Nitinol suprarenal stent with anchoring pins</li></li></ul><li>Endurant Delivery System<br /><ul><li>Accurate stepwise proximal deployment of the stentgraft
Controlled release of the suprarenal anchoring pins</li></li></ul><li>Endurant Radio-Opaque Markers<br />“e” marker assists with A/P view and identifies contralateral gate<br />Flow divider marker for accurate contralateral limb placement<br />Contralateral gate ring marker assists with cannulation<br />
Endurant Delivery System<br />Allows for Slow Deliberate <br />and Accurate Proximal Deployment<br />
The Endurant US Regulatory Study<br />Follow-up<br /><ul><li>Schedule: 1, 6 and 12 months
Six Deaths during first year. None AAA related (CEC)</li></ul>Primary Cause of Death Days from Implant<br /> Stroke 90<br /> COPD 128<br /> Pulmonary fibrosis 215<br /> Lung cancer 267<br /> Multiple organ/system failure 280<br /> Metastatic bladder cancer 320<br /> Lung cancer 458<br />
The Endurant US Regulatory Study<br />Imaging Follow-up<br /><ul><li>Schedule: 1, 6 and 12 months
1 Stenosis</li></li></ul><li>The Endurant US Regulatory Study<br />Re-interventions up to one Year<br />
The Endurant Endograft<br />Summary and Conclusions<br /><ul><li>Results up to one year with the Endurant Endograft are quite encouraging
The Endurant Endograft appears to be a Safe and Effective new device for the management of AAA</li></li></ul><li>ENGAGE Overview<br />ENGAGE is a worldwide prospective registry of Post-market use of the ENDURANT endograft in the treatment of AAA <br />Study Plan<br />Enrollment: 1200 patients at 80 sites worldwide (5 year FU)<br />Primary endpoint: Treatment success at 12 months<br />Oversight: Executive committee (7 Investigators)<br />Study Purpose<br />Prospectively collect global ‘real life’ data<br />Real world patients<br />Minimal Inclusion / Exclusion Criteria<br />Real-world practice<br />Patients are followed per institution standard practices<br />
ENGAGE Interim Analysis<br />Acute Procedural Data for first 839 Patients Enrolled<br />Baseline Characteristics<br />AAA Size > 50mm 88.2%<br />Proximal Neck<br /> Length 27.8 mm + 13.4<br /> Length < 15 mm 18.1%<br />Procedural Data<br />Deployment Success 99.6%<br />Implant Duration 90 min (20-300)<br />General Anesthesia 63.3%<br />Length of Stay 5 days (0.5 – 217)<br /> * As of 05 October 2010<br />
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