PURPOSE: The technique of fenestrated and branched endovascular aneurysm repair (EVAR) has been used for the treatment a variety of aortic aneurysms. Although technically successful, longer-term results have been lacking. This article reports on the mid-term results of aneurysm repair with fenestrated and branched endografts from a European center with a large endovascular experience. METHODS: Between 2001 and 2005, 38 patients were prospectively enrolled in a single institution, investigational device protocol database. Indications for fenestrated or branched EVAR included unfavorable anatomy for traditional EVAR and an abdominal aortic aneurysm >5.5 cm in maximum diameter. Customized stent-grafts were either fenestrated or branched and based on the Zenith system. Data were analyzed on an intention-to-treat basis. Differences between groups were determined using analysis of variance with P < .05 considered significant. RESULTS: The mean (SD) follow-up was 25.8 +/- 12.7 months (median, 25.0 months; range, 9 to 46 months), and no patients were lost to follow-up. All cause mortality was 13% (5/38), with all deaths occurring within the first postoperative year; 30-day mortality was 2.6%. No patient died during the operation. Completion angiography demonstrated successful sealing in 37 of 38 patients and an overall operative visceral vessel perfusion rate of 94% (82/87). Cumulative visceral branch patency was 92% at 46 months. Stent occlusions, when they did occur, all happened within the first postoperative year. All postoperative occlusions occurred in unstented fenestrations or scallops. No occlusions occurred in stented vessels. The difference in serum creatinine preoperatively and postoperatively at 6 months, 1, 2, and 3 years was not significant (P = NS). No patient required dialysis. The aneurysm sac size decreased significantly during the first year and then remained stable (P < .05). Limb perfusion as assessed by the ankle/brachial index was not affected by the presence of a fenestrated or branched endograft. CONCLUSIONS: The intermediate-term results of fenestrated and branched endografts support their continued use in patients with anatomic contraindications for standard EVAR. Close surveillance is mandatory for early identification of visceral or branched vessel stenosis and preocclusion. All cases of failure appear to occur during the first year and then level off in subsequent longer-term follow-up. This includes death, secondary interventions, branch vessel patency, and complications. As the procedure matures, long-term results and randomized clinical trials will ultimately be required to determine the safety, efficacy, and stability of this system.
PURPOSE: The technique of fenestrated and branched endovascular aneurysm repair (EVAR) has been used for the treatment a variety of aortic aneurysms. Although technically successful, longer-term results have been lacking. This article reports on the mid-term results of aneurysm repair with fenestrated and branched endografts from a European center with a large endovascular experience. METHODS: Between 2001 and 2005, 38 patients were prospectively enrolled in a single institution, investigational device protocol database. Indications for fenestrated or branched EVAR included unfavorable anatomy for traditional EVAR and an abdominal aortic aneurysm >5.5 cm in maximum diameter. Customized stent-grafts were either fenestrated or branched and based on the Zenith system. Data were analyzed on an intention-to-treat basis. Differences between groups were determined using analysis of variance with P < .05 considered significant. RESULTS: The mean (SD) follow-up was 25.8 +/- 12.7 months (median, 25.0 months; range, 9 to 46 months), and no patients were lost to follow-up. All cause mortality was 13% (5/38), with all deaths occurring within the first postoperative year; 30-day mortality was 2.6%. No patient died during the operation. Completion angiography demonstrated successful sealing in 37 of 38 patients and an overall operative visceral vessel perfusion rate of 94% (82/87). Cumulative visceral branch patency was 92% at 46 months. Stent occlusions, when they did occur, all happened within the first postoperative year. All postoperative occlusions occurred in unstented fenestrations or scallops. No occlusions occurred in stented vessels. The difference in serum creatinine preoperatively and postoperatively at 6 months, 1, 2, and 3 years was not significant (P = NS). No patient required dialysis. The aneurysm sac size decreased significantly during the first year and then remained stable (P < .05). Limb perfusion as assessed by the ankle/brachial index was not affected by the presence of a fenestrated or branched endograft. CONCLUSIONS: The intermediate-term results of fenestrated and branched endografts support their continued use in patients with anatomic contraindications for standard EVAR. Close surveillance is mandatory for early identification of visceral or branched vessel stenosis and preocclusion. All cases of failure appear to occur during the first year and then level off in subsequent longer-term follow-up. This includes death, secondary interventions, branch vessel patency, and complications. As the procedure matures, long-term results and randomized clinical trials will ultimately be required to determine the safety, efficacy, and stability of this system.
Authors: Salvatore T Scali; Alyson Waterman; Robert J Feezor; Tomas D Martin; Philip J Hess; Thomas S Huber; Adam W Beck Journal: J Vasc Surg Date: 2013-05-21 Impact factor: 4.268