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Thirty day Outcomes and Costs of Fenestrated and Branched Stent Grafts versus Open Repair for Complex Aortic Aneurysms
Selected Abstracts from the August Issue of the European Journal of Vascular and Endovascular Surgery A. Ross Naylor, MBChB, MD, FRCS, Editor-in-Chief, and Philippe H. Kolh, MD, PhD, Senior Editor
Endovascular Aneurysm Sealing for Infrarenal Abdominal Aortic Aneurysms: 30-Day Outcomes of 105 Patients in a Single Centre Brownrigg J.R.W., de Bruin J.L., Rossi L., Karthikesalingam A., Patterson B., Holt P.J., Hinchliffe R.H., Morgan R., Loftus I.M., Thompson M.M. Eur J Vasc Endovasc Surg 2015;50:157-64. Objective: Endovascular aneurysm sealing (EVAS) has been proposed as a novel alternative to endovascular aneurysm repair (EVAR) in patients with infrarenal abdominal aortic aneurysms (AAA). The early clinical experience, technical refinements, and learning curve of EVAS in the treatment of AAA at a single institution are presented. Methods: One-hundred and five patients were treated with EVAS between March 2013 and November 2014. Prospective data were recorded on consecutive patients receiving EVAS. Data included demographics, preoperative aneurysm morphology, and 30-day outcomes, including rates of endoleak, limb occlusion, reintervention, and death. Postoperative imaging consisted of duplex ultrasound and computed tomographic angiography. Results: The mean age of the cohort was 76 6 8 years and 12% were female. Adverse neck morphology was present in 72 (69%) patients, including aneurysm neck length <10 mm (20%), neck diameter >32 mm (18%), b-angulation >60 (21%), and conical aneurysm neck (51%). There was one death within 30 days. The incidence of Type 1 endoleak within 30 days was 4% (n ¼ 4); all were treated successfully with transcatheter embolisation. All four proximal endoleaks were associated with technical issues that resulted in procedure refinement, and all were in patients with adverse proximal aortic necks. The persistent Type 1 endoleak rate at 30 days was 0% and there were no Type 2 or Type 3 endoleaks. Angioplasty and adjunctive stenting were performed for postoperative limb stenosis in three patients (3%). Conclusions: EVAS appears to be associated with reasonable 30-day outcomes despite the necessity of procedural evolution in the early adoption of this technique. EVAS appears to be applicable to patients with challenging aortic morphology and endoleak rates should reduce with procedural experience. The utility of EVAS will be defined by the durability of the device in long-term follow-up, although the absence of Type 2 endoleaks is encouraging. Interaction of Biomechanics with Extracellular Matrix Components in Abdominal Aortic Aneurysm Wall Tanios F., Gee M.W., Pelisek J., Kehl S., Biehler J., Grabher-Meier V., Wall W.A., Eckstein H.-H., Reeps C. Eur J Vasc Endovasc Surg 2015;50:167-74. Objective: Little is known about the interactions between extracellular matrix (ECM) proteins and locally acting mechanical conditions and material macroscopic properties in abdominal aortic aneurysm (AAA). In this study, ECM components were investigated with correlation to corresponding biomechanical properties and loads in aneurysmal arterial wall tissue. Methods: Fifty-four tissue samples from 31 AAA patients (30_; max. diameter Dmax 5.98 6 1.42 cm) were excised from the aneurysm sac. Samples were divided for corresponding immunohistological and mechanical analysis. Collagen I and III, total collagen, elastin, and proteoglycans were quantified by computational image analysis of histological staining. Pre-surgical CT data were used for 3D segmentation of the AAA and calculation of mechanical conditions by advanced finite element analysis. AAA wall stiffness and strength were assessed by repeated cyclical, sinusoidal and destructive tensile testing. Results: Amounts of collagen I, III, and total collagen were increased with higher local wall stress (P ¼ .002, .017, .030, respectively) and strain (P ¼ .002, .012, .020, respectively). AAA wall failure tension exhibited a positive correlation with collagen I, total collagen, and proteoglycans (P ¼ .037, .038, .022, respectively). a-Stiffness correlated with collagen I, III, and total collagen (P ¼ .011, .038, and .008), while b-stiffness
correlated only with proteoglycans (P ¼ .028). In contrast, increased thrombus thickness was associated with decreased collagen I, III, and total collagen (P ¼ .003, .020, .015, respectively), and AAA diameter was negatively associated with elastin (P ¼ .006). Conclusions: The present results indicate that in AAA, increased locally acting biomechanical conditions (stress and strain) involve increased synthesis of collagen and proteoglycans with increased failure tension. These findings confirm the presence of adaptive biological processes to maintain the mechanical stability of AAA wall. Thirty day Outcomes and Costs of Fenestrated and Branched Stent Grafts versus Open Repair for Complex Aortic Aneurysms Michel M., Becquemin J.-P., Clément M.-C., Marzelle J., Quelen C., Durand-Zaleski I., on behalf of the WINDOW Trial Participants. Eur J Vasc Endovasc Surg 2015;50:189-96. Objective: To compare 30 day outcomes and costs of fenestrated and branched stent grafts (f/b EVAR) and open surgery (OSR) for the treatment of complex abdominal aortic aneurysms (AAA) and thoraco-abdominal aortic aneurysms (TAAA). Methods: The multicenter prospective registry WINDOW was set up to evaluate f/b EVAR in high risk patients with para/juxtarenal AAA, and infradiaphragmatic and supradiaphragmatic TAAA. A control group of patients treated by OSR was extracted from the national hospital discharge database. The primary endpoint was 30 day mortality. Secondary endpoints included severe complications, length of stay, and costs. Mortality was assessed by survival analysis and uni/multivariate Cox regression analyses using pre- and post-operative characteristics. Bootstrap methods were used to estimate the cost-effectiveness of f/b EVAR versus OSR. Results: Two hundred and sixty eight cases and 1,678 controls were included. There was no difference in 30 day mortality (6.7% vs 5.4%, P ¼ 0.40), but costs were higher with f/b EVAR (V38,212 vs V16,497, P < .001). After group stratification, mortality was similar with both treatments for para/juxtarenal AAA (4.3% vs 5.8%, P ¼ .26) and supradiaphragmatic TAAA (11.9% vs 19.7%, P ¼ .70), and higher with f/b EVAR for infradiaphragmatic TAAA (11.9% vs 4.0%, P ¼ .010). Costs were higher with f/b EVAR for para/juxtarenal AAA (V34,425 vs V14,907, P < .0001) and infradiaphragmatic TAAA (V37,927 vs V17,530, P < .0001), but not different for supradiaphragmatic TAAA (V54,710 vs V44,163, P ¼ .18). Conclusion: f/b EVAR does not appear justified for patients with para/juxtarenal AAA and infradiaphragmatic TAAA fit for OSR but may be an attractive option for patients with para/juxtarenal AAA not eligible for surgery and patients with supradiaphragmatic TAAA. Clinical Trial Registration: http://www.clinicaltrials.gov/ct2/show/NCT01168037; identifier: NCT01168037 (WINDOW registry). Strategies for Free Flap Transfer and Revascularisation with Long-term Outcome in the Treatment of Large Diabetic Foot Lesions Kallio M., Vikatmaa P., Kantonen I., Lepäntalo M., Venermo M., Tukiainen E. Eur J Vasc Endovasc Surg 2015;50:222-9. Objective/Background: To analyse the impact of ischaemia and revascularisation strategies on the long-term outcome of patients undergoing free flap transfer (FFT) for large diabetic foot lesions penetrating to the tendon, bone, or joint. Methods: Foot lesions of 63 patients with diabetes (median age 56 years; 70% male) were covered with a FTT in 1991-2003. Three groups were formed and followed until 2009: patients with a native in line artery to the ulcer area (n = 19; group A), patients with correctable ischaemia requiring vascular bypass (n = 32; group B), and patients with uncorrectable ischaemia lacking a recipient vessel in the ulcer area (n = 12; group C).
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Endovascular Aneurysm Sealing for Infrarenal Abdominal Aortic Aneurysms: 30-Day Outcomes of 105 Patients in a Single Centre Brownrigg J.R.W., de Bruin J.L., Rossi L., Karthikesalingam A., Patterson B., Holt P.J., Hinchliffe R.H., Morgan R., Loftus I.M., Thompson M.M. Eur J Vasc Endovasc Surg 2015;50:157-64. Objective: Endovascular aneurysm sealing (EVAS) has been proposed as a novel alternative to endovascular aneurysm repair (EVAR) in patients with infrarenal abdominal aortic aneurysms (AAA). The early clinical experience, technical refinements, and learning curve of EVAS in the treatment of AAA at a single institution are presented. Methods: One-hundred and five patients were treated with EVAS between March 2013 and November 2014. Prospective data were recorded on consecutive patients receiving EVAS. Data included demographics, preoperative aneurysm morphology, and 30-day outcomes, including rates of endoleak, limb occlusion, reintervention, and death. Postoperative imaging consisted of duplex ultrasound and computed tomographic angiography. Results: The mean age of the cohort was 76 6 8 years and 12% were female. Adverse neck morphology was present in 72 (69%) patients, including aneurysm neck length <10 mm (20%), neck diameter >32 mm (18%), b-angulation >60 (21%), and conical aneurysm neck (51%). There was one death within 30 days. The incidence of Type 1 endoleak within 30 days was 4% (n ¼ 4); all were treated successfully with transcatheter embolisation. All four proximal endoleaks were associated with technical issues that resulted in procedure refinement, and all were in patients with adverse proximal aortic necks. The persistent Type 1 endoleak rate at 30 days was 0% and there were no Type 2 or Type 3 endoleaks. Angioplasty and adjunctive stenting were performed for postoperative limb stenosis in three patients (3%). Conclusions: EVAS appears to be associated with reasonable 30-day outcomes despite the necessity of procedural evolution in the early adoption of this technique. EVAS appears to be applicable to patients with challenging aortic morphology and endoleak rates should reduce with procedural experience. The utility of EVAS will be defined by the durability of the device in long-term follow-up, although the absence of Type 2 endoleaks is encouraging. Interaction of Biomechanics with Extracellular Matrix Components in Abdominal Aortic Aneurysm Wall Tanios F., Gee M.W., Pelisek J., Kehl S., Biehler J., Grabher-Meier V., Wall W.A., Eckstein H.-H., Reeps C. Eur J Vasc Endovasc Surg 2015;50:167-74. Objective: Little is known about the interactions between extracellular matrix (ECM) proteins and locally acting mechanical conditions and material macroscopic properties in abdominal aortic aneurysm (AAA). In this study, ECM components were investigated with correlation to corresponding biomechanical properties and loads in aneurysmal arterial wall tissue. Methods: Fifty-four tissue samples from 31 AAA patients (30_; max. diameter Dmax 5.98 6 1.42 cm) were excised from the aneurysm sac. Samples were divided for corresponding immunohistological and mechanical analysis. Collagen I and III, total collagen, elastin, and proteoglycans were quantified by computational image analysis of histological staining. Pre-surgical CT data were used for 3D segmentation of the AAA and calculation of mechanical conditions by advanced finite element analysis. AAA wall stiffness and strength were assessed by repeated cyclical, sinusoidal and destructive tensile testing. Results: Amounts of collagen I, III, and total collagen were increased with higher local wall stress (P ¼ .002, .017, .030, respectively) and strain (P ¼ .002, .012, .020, respectively). AAA wall failure tension exhibited a positive correlation with collagen I, total collagen, and proteoglycans (P ¼ .037, .038, .022, respectively). a-Stiffness correlated with collagen I, III, and total collagen (P ¼ .011, .038, and .008), while b-stiffness
correlated only with proteoglycans (P ¼ .028). In contrast, increased thrombus thickness was associated with decreased collagen I, III, and total collagen (P ¼ .003, .020, .015, respectively), and AAA diameter was negatively associated with elastin (P ¼ .006). Conclusions: The present results indicate that in AAA, increased locally acting biomechanical conditions (stress and strain) involve increased synthesis of collagen and proteoglycans with increased failure tension. These findings confirm the presence of adaptive biological processes to maintain the mechanical stability of AAA wall. Thirty day Outcomes and Costs of Fenestrated and Branched Stent Grafts versus Open Repair for Complex Aortic Aneurysms Michel M., Becquemin J.-P., Clément M.-C., Marzelle J., Quelen C., Durand-Zaleski I., on behalf of the WINDOW Trial Participants. Eur J Vasc Endovasc Surg 2015;50:189-96. Objective: To compare 30 day outcomes and costs of fenestrated and branched stent grafts (f/b EVAR) and open surgery (OSR) for the treatment of complex abdominal aortic aneurysms (AAA) and thoraco-abdominal aortic aneurysms (TAAA). Methods: The multicenter prospective registry WINDOW was set up to evaluate f/b EVAR in high risk patients with para/juxtarenal AAA, and infradiaphragmatic and supradiaphragmatic TAAA. A control group of patients treated by OSR was extracted from the national hospital discharge database. The primary endpoint was 30 day mortality. Secondary endpoints included severe complications, length of stay, and costs. Mortality was assessed by survival analysis and uni/multivariate Cox regression analyses using pre- and post-operative characteristics. Bootstrap methods were used to estimate the cost-effectiveness of f/b EVAR versus OSR. Results: Two hundred and sixty eight cases and 1,678 controls were included. There was no difference in 30 day mortality (6.7% vs 5.4%, P ¼ 0.40), but costs were higher with f/b EVAR (V38,212 vs V16,497, P < .001). After group stratification, mortality was similar with both treatments for para/juxtarenal AAA (4.3% vs 5.8%, P ¼ .26) and supradiaphragmatic TAAA (11.9% vs 19.7%, P ¼ .70), and higher with f/b EVAR for infradiaphragmatic TAAA (11.9% vs 4.0%, P ¼ .010). Costs were higher with f/b EVAR for para/juxtarenal AAA (V34,425 vs V14,907, P < .0001) and infradiaphragmatic TAAA (V37,927 vs V17,530, P < .0001), but not different for supradiaphragmatic TAAA (V54,710 vs V44,163, P ¼ .18). Conclusion: f/b EVAR does not appear justified for patients with para/juxtarenal AAA and infradiaphragmatic TAAA fit for OSR but may be an attractive option for patients with para/juxtarenal AAA not eligible for surgery and patients with supradiaphragmatic TAAA. Clinical Trial Registration: http://www.clinicaltrials.gov/ct2/show/NCT01168037; identifier: NCT01168037 (WINDOW registry). Strategies for Free Flap Transfer and Revascularisation with Long-term Outcome in the Treatment of Large Diabetic Foot Lesions Kallio M., Vikatmaa P., Kantonen I., Lepäntalo M., Venermo M., Tukiainen E. Eur J Vasc Endovasc Surg 2015;50:222-9. Objective/Background: To analyse the impact of ischaemia and revascularisation strategies on the long-term outcome of patients undergoing free flap transfer (FFT) for large diabetic foot lesions penetrating to the tendon, bone, or joint. Methods: Foot lesions of 63 patients with diabetes (median age 56 years; 70% male) were covered with a FTT in 1991-2003. Three groups were formed and followed until 2009: patients with a native in line artery to the ulcer area (n = 19; group A), patients with correctable ischaemia requiring vascular bypass (n = 32; group B), and patients with uncorrectable ischaemia lacking a recipient vessel in the ulcer area (n = 12; group C).
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