Claude D Vaislic1, Jean Noël Fabiani2, Sidney Chocron3, Jacques Robin4, Victor S Costache5, Jean-Pierre Villemot6, Jean Marc Alsac2, Pascal N Leprince7, Thierry Unterseeh8, Eric Portocarrero6, Yves Glock9, Hervé Rousseau10. 1. Department of Cardiac, Vascular, and Thoracic Surgery, Centre Hospitalier Privé Parly 2, Le Chesnay, France claudevaislic@hotmail.com. 2. Department of Cardiovascular Surgery, Hôpital Européen Georges-Pompidou, Paris, France. 3. Department of Thoracic and Cardiovascular Surgery, Hôpital Jean Minjoz, Besançon, France. 4. Department of Cardiovascular Surgery, Hôpital Louis Pradel, Lyon-Bron, France. 5. Department of Cardiac Surgery, Centre Hospitalier de la Région d'Annecy, Metz-Tessy, France. 6. Department of Cardiovascular Surgery and Transplantation, CHU-Nancy, Hôpital d'adultes de Brabois, Nancy, France. 7. Department of Thoracic and Cardiovascular Surgery, Hôpital Pitié-Salpétrière, Paris, France. 8. Department of Interventional Cardiology, Institut Cardiovasculaire Paris Sud, Hôpital Privé Claude Galien, Quincy-sous-Sénart, France. 9. Department of Cardiovascular Surgery, CHU Toulouse, Hôpital Rangueil, Toulouse, France. 10. Department of Radiology, CHU Toulouse, Hôpital Rangueil, Toulouse, France.
Abstract
PURPOSE: To evaluate midterm outcomes of endovascular repair of types II and III thoracoabdominal aortic aneurysms (TAAA) using the Multilayer Flow Modulator (MFM) in patients unsuitable for open surgery or fenestrated stent-grafts. METHODS: In the prospective, multicenter, nonrandomized STRATO trial (EudraCT registration: 2009-013678-42; ClinicalTrials.gov identifier NCT01756911), 23 patients (mean age 75.8 years; 19 men) with Crawford type II and III TAAA (mean diameter 6.5 cm) were implanted between April 2010 and February 2011. Outcomes included all-cause mortality and stable aneurysm thrombosis with associated branch vessel patency. RESULTS: Through 36 months, there were 7 deaths (none confirmed as aneurysm-related), and no cases of spinal cord injury, device migration or fracture, or respiratory, renal, or peripheral complications. Three patients were lost to follow-up and 2 devices were explanted. The device was patent in the 11 remaining patients at 3 years. Stable aneurysm thrombosis was achieved for 15 of 20 patients at 12 months, 12 of 13 at 24 months, and 10 of 11 at 36 months. The rate of branch patency was 96% at 12 months (primary patency), 100% at 24 months, and 97% at 36 months. Nine patients suffered from endoleaks (attachment site or device overlap); 9 patients underwent 11 reinterventions (3 surgical). Maximum aneurysm diameter was stable for 18 of 20 patients at 12 months, 11 of 13 at 24 months, and 9 of 11 at 36 months. For 10 patients with computed tomography at 36 months, the mean ratio of aneurysm flow volume to total volume had decreased by 83%; the mean ratio of thrombus volume to total volume increased by 159%. CONCLUSION: Through 3 years, endovascular repair with the MFM appears to be safe and effective while successfully maintaining branch vessel patency.
PURPOSE: To evaluate midterm outcomes of endovascular repair of types II and III thoracoabdominal aortic aneurysms (TAAA) using the Multilayer Flow Modulator (MFM) in patients unsuitable for open surgery or fenestrated stent-grafts. METHODS: In the prospective, multicenter, nonrandomized STRATO trial (EudraCT registration: 2009-013678-42; ClinicalTrials.gov identifier NCT01756911), 23 patients (mean age 75.8 years; 19 men) with Crawford type II and III TAAA (mean diameter 6.5 cm) were implanted between April 2010 and February 2011. Outcomes included all-cause mortality and stable aneurysm thrombosis with associated branch vessel patency. RESULTS: Through 36 months, there were 7 deaths (none confirmed as aneurysm-related), and no cases of spinal cord injury, device migration or fracture, or respiratory, renal, or peripheral complications. Three patients were lost to follow-up and 2 devices were explanted. The device was patent in the 11 remaining patients at 3 years. Stable aneurysm thrombosis was achieved for 15 of 20 patients at 12 months, 12 of 13 at 24 months, and 10 of 11 at 36 months. The rate of branch patency was 96% at 12 months (primary patency), 100% at 24 months, and 97% at 36 months. Nine patients suffered from endoleaks (attachment site or device overlap); 9 patients underwent 11 reinterventions (3 surgical). Maximum aneurysm diameter was stable for 18 of 20 patients at 12 months, 11 of 13 at 24 months, and 9 of 11 at 36 months. For 10 patients with computed tomography at 36 months, the mean ratio of aneurysm flow volume to total volume had decreased by 83%; the mean ratio of thrombus volume to total volume increased by 159%. CONCLUSION: Through 3 years, endovascular repair with the MFM appears to be safe and effective while successfully maintaining branch vessel patency.
Authors: Anna Paula Weinhardt Baptista-Strazzi; Ricardo Aun; Igor Rafael Sincos; Allana M Tobita; Maria Fernanda Cassino Portugal; Vitória Penido de Paula; Oskar Kaufmann; Nelson Wolosker Journal: Clinics (Sao Paulo) Date: 2021-05-21 Impact factor: 2.365
Authors: Victor S Costache; Jorn P Meekel; Andreea Costache; Tatiana Melnic; Crina Solomon; Anca M Chitic; Cristian Bucurenciu; Horatiu Moldovan; Iulian Antoniac; Gabriela Candea; Kak K Yeung Journal: Materials (Basel) Date: 2020-05-15 Impact factor: 3.623