Global Post-Market Clinical Follow-up of the Treovance Stent-Graft for Endovascular Aneurysm Repair: One-Year Results From the RATIONALE Registry
| Autor: | Raman Uberoi, Carlo Setacci, Mario Lescan, Antonio Lorido, David Murray, Zoltán Szeberin, Tomasz Zubilewicz, Vincent Riambau, Angsu Chartrungsan, Jörg Tessarek, Marek Iłżecki, Hartmuth Gortz, Matthias Thenholt, Maher Fattoum, Semih Buz, Piergiorgio Cao, Domenico Benevento, Giancarlo Palasciano, Feras Abdallah, John Boyle, S. Llagostera Pujol, Carlos Esteban, Nilo Mosquera, Enrique Aracil Sanus, Ignacio Iglesias Negreira, J.T.F.J. Raymakers, Joost van Herwaarden, Georgios Pitoulias, Theodoros Kratimenos, Carl Magnus Wahlgren, Claes Forssell, Greg Fulton, Lars Lonn, Gustav Pedersen, Jorge Vergara, Manuel Espindola Silva, Stephen Wing-Keung Cheng, Phan Minh Anh, Carlos David Calderas, Patrick Bohan |
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| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: |
Male
Time Factors medicine.medical_treatment 030204 cardiovascular system & hematology 030230 surgery registry Endovascular aneurysm repair endovascular aneurysm repair 0302 clinical medicine Postoperative Complications Endovascular Aortic Repair Risk Factors Occlusion 80 and over Prospective Studies Registries Aged 80 and over Endovascular Procedures endograft Middle Aged Abdominal aortic aneurysm Aortic Aneurysm Product Surveillance Postmarketing Treatment Outcome Female Stents Cardiology and Cardiovascular Medicine Adult medicine.medical_specialty Adolescent endoleak occlusion Prosthesis Design Risk Assessment 03 medical and health sciences Blood Vessel Prosthesis Implantation Young Adult abdominal aortic aneurysm medicine Product Surveillance Postmarketing Humans Radiology Nuclear Medicine and imaging Abdominal cardiovascular diseases mortality reintervention stent-graft Aged Aortic Aneurysm Abdominal Blood Vessel Prosthesis business.industry Stent medicine.disease Surgery business Follow-Up Studies |
| Zdroj: | Journal of Endovascular Therapy |
| Popis: | Purpose: To evaluate the safety and performance of the Treovance stent-graft. Methods: The global, multicenter RATIONALE registry ( ClinicalTrials.gov; identifier NCT03449875) prospectively enrolled 202 patients (mean age 73.0±7.8 years; 187 men) with abdominal aortic aneurysms (AAA) suitable for endovascular aneurysm repair (EVAR) using the Treovance. The composite primary safety endpoint was site-reported all-cause mortality and major morbidity. The primary efficacy outcome was clinical success. Further outcomes evaluated included technical success; stent-graft migration, patency, and integrity; endoleak; and aneurysm size changes. Results: Technical success was 96% (194/202); 8 patients had unresolved type I endoleaks at the end of the procedure. There was no 30-day mortality and 1% major morbidity (1 myocardial infarction and 1 bowel ischemia). Clinical success at 1 year was confirmed in 194 (96%) patients; 6 of 8 patients had new/persistent endoleaks and 2 had aneurysm expansion without identified endoleak. A total of 8 (4%) reinterventions were required during the mean 13.7±3.1 months of follow-up (median 12.8). At 1 year, the Kaplan-Meier estimate for freedom from reintervention was 95.6% (95% CI 91.4% to 97.8%). Other estimates were 95.5% (95% CI 91.7% to 97.6%) for freedom from endoleak type I/III and 97.4% (95% CI 94.2% to 98.9%) for freedom from aneurysm expansion. Thirteen (6.4%) patients died; no death was aneurysm related. Conclusion: The RATIONALE registry showed favorable safety and clinical performance of the Treovance stent-graft for the treatment of infrarenal AAAs in a real-world setting. |
| Databáze: | OpenAIRE |
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